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Beckman Coulter Immage 800 - Frank`s Hospital Workshop

1. Escape Key Function Keys Tab Key Caps Lock Key Shift Keys Control Keys Alt Keys DUO gi Ov Backspace Key Enter Key Delete Key Page Up Key Page Down Key Arrow Keys Figure 2 14 IMMAGE 800 Keyboard E010331L CDR IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 23 Computer Port Connections Port Connections Figure 2 15 shows the back of the computer and where each cable connects A011412P EPS Printer Port Monitor Port Mouse Keyboard Port Instrument Port Apr Figure 2 15 CPU Ports Proper Care and Handling of a Floppy Diskette Diskettes require special care in handling Recommended diskette 3 5 inch Double sided High density IBM formatted diskette Store away from electrical motors power supplies or generators Keep away from magnets and magnetic fields Proper Care and Handling of a Compact Disk Compact disks CD ROMs require special care in handling Store away from direct sunlight excessive heat and humidity Hold the CD ROM by the edges Replace the CD ROM in its case after use System Description IMMAGE 800 Operations Manual A11403 Page 2 24 March 2004 Printer Description Printer Description The printer supplied with the IMMAGE 800 Immunochemis
2. Backup Follow the steps below to back up the database Step Action 1 Select Utilities from the menu bar 2 Select lt 6 gt Backup Restore from the Utilities dialog box OR Enter 6 in the Option No field and press Enter Select to Backup to Diskette Copy the database to a diskette When prompted insert a diskette into the floppy disk drive Backup to Hard Disk Copy the database to the hard disk 3 Select lt OK gt to back up the database OR Select lt Cancel gt to exit and return to the Utilities screen 4 When Backup is complete a confirmation is displayed on the screen Refer to Figure 10 32 Select lt OK gt to exit Utilities IMMAGE 800 Operations Manual A11403 Page 10 64 March 2004 Backup Restore Restore Database version 5 78 82 dated 8478271998 was successfully backed up Figure 10 32 Backup Complete Confirmation Dialog Box Restore Follow the steps below to restore the database Step Action 1 Select Utilities from the menu bar 2 Select lt 6 gt Backup Restore from the Utilities dialog box OR Select 6 in the Option No field and press Enter 3 NOTICE Restoring the entire database will overwrite the current database and replace it with the backed up database Select To Restore Entire Database Copy the entire database into the from Diskette system from the backup diskette When prompted insert the b
3. Hr M 2 26 Screen Formatosi I EE 2 27 A 2 30 Buttons A A A ba Ent 2 31 FOS IE BUS alot 2 32 Check BOXES iio dad da 2 33 Penormine SoftWare FUCSIA SS 2 34 PELE CHING ves CO SIMD o onse us eio qa im aie sued oy wash eM M 2 36 Dialog BONES NN dA d blau aou tcu tnu OCR Eon een 2 37 Deleting Data From a Text Field and Printing Data from a Screen sss 2 38 Page BACC EDI arto 2 30 Programi Structure mosike irae io 2 40 Sample Programming Overview ER 2 45 System Specifications and Characteristics veis pia Greed 2 46 Instcumelit Spec HTCALORHSO eoe E A E A E 2 46 Peripheral Devices Specifications ssssesssesssssesssessresseessererseetsstessersstesseeesseeessresseesseessees 2 48 Sample Contaimer Information ise cnet eii ers At ia 2 40 sample Containers Allowed aiii ida 2 49 Barcode Types and Cp Ons a da 2 50 Bar Code Label Specifications us suos snein QNSE ar ESAE 2 52 Applying Bar Code Labels 5 reete ter verae nai Gu dev 2 54 Sample VOM lidad 2 55 Loading Tubes Into Racks sta deans n 2 56 Instrument Operation OVOEVIQW tt a iro uad NE IDAS da dano 2 57 A ris ets eda ox stie pios ne qe eda ie ua dan vce sr Eds 2 57 IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 1 Overview Introduction Hardware Components Overview Introduction The IMMAGE 800 Immunochemistry System is a bench top analyzer composed of the IMMAGE 800 instrument
4. Step Action continued 12 Type the last cuvette number 39 in the Cuvette field to stop the wash in the Ending Range field 13 Select lt OK gt to start washing the cuvettes 3 of 3 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 19 As Indicated Maintenance Washing Cuvettes Washing Cuvettes Washing the cuvettes may become necessary when performing maintenance or when troubleshooting To access cuvette washing perform the following steps Step Action 1 Select Utilities from the menu bar 2 Select 7 Wash Cuvettes from the Utilities dialog box OR Enter 7 in the Option No field and press Enter 3 Type the first cuvette number 1 to begin the wash in the Starting Range field and press Enter 4 Type the last cuvette number 39 to stop the wash in the Ending Range field 5 Select lt OK gt to start washing the cuvettes NOTICE If Stop is selected to discontinue the cuvette wash Homing of the system is necessary prior to using the Sample Carousel Advance button OR Select Cancel to return to Utilities dialog box without starting the wash Replacing Syringes To replace the reagent or sample syringes perform the following steps Step Action 1 Select Utils from menu bar Select 3 Diagnostics Select 2 Callable Diagnostics Select 1 Electro mechanical motion Select Home All F3 Se
5. 2 56 Checking reagent calibration status 6 19 7 8 Batch program sss eee 7 46 Checking status 0 0 0 eese esee 7 6 Battery oo READERS ie eee a ES 10 14 Checking wash solution o ocoo oo ooo 7 9 Bi directional ooooooommom o 2 45 7 82 Chemistry information manual 1 3 Biohazard label eese 1 11 Chemistry protocol diskette 5 66 Biohazardous sees 10 18 CHOOSING A ore d seek ees a ee Dt Eae d 2 36 Biological samples Circuit board area Sees ay ease ate os 2 15 Pathogens eiii eee 1 8 Cleaning filters 0 0 0 0 eee eee 10 12 Bleach ar o ia ere 10 9 10 16 Clear chems sce beber RP EE 7 65 Booting up wach fe cesses eme WR 1 7 4 2 Clear samples dialog DOX o ooooooooo 7 77 B bbles ipe bx tier saute ida erage 10 10 Clearing a buffer or diluent position 6 12 Buttons 2 04 choke e io 2 31 Clearing all 72 chemistry positions 5 5 Clearing by rack and position 7 79 Clearing events lilsll else es 10 49 Clearing racks 0 0 cece eee 7 4 IMMAGE 800 Operations Manual A11403 Index March 2004 Page i of vii Clearing segments 0 0c eee eee eee 7 6 Decontaminate 0 e eee eee 10 14 Codabal uu erii it eae Pa debi 2 50 Define edit control 9 12 9 14 Define code length o o ooo 2 51
6. No software intervention is required Priming is not required IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 13 Loading Unloading Reagent Cartridges Introduction Loading Unloading Reagent Cartridges Introduction The reagent cartridges must be loaded before performing a run Description of Cartridge Bar Code The Beckman Coulter reagent cartridge bar code contains the following information Chem ID Reagent lot number Reagent cartridge serial number Limits Up to 24 cartridges can be loaded on the reagent carousel Only one lot of any reagent may be placed on the reagent carousel Multiple cartridges of the same lot may be placed on the carousel Loading Reagent Cartridges The instrument status must be in Standby in order to proceed with the steps below to load the reagent cartridge s Step Action 1 Select Rgts Cal from the menu bar 2 Invert each cartridge gently before removing screw caps Remove the screw caps from the cartridge s Check each compartment for bubbles and remove bubbles if present Place evaporation caps on each cartridge compartment Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix E Evaporation Cap Installation Instructions Note Some cartridges do not have reagent in compartment B Open the reagent compartment cover Place the reagent cartridges onto the reagent carou
7. 4 3 12 Replacing mechanical or electrical parts 1 7 1 8 Protein rate response curve 0 3 5 Replacing the same l0t o o o o 6 11 Protocol diskette o oooooooooo 5 66 Replicates 5 58 7 28 7 46 7 70 Requesting calibration Request calibration screen 6 27 Q STAT calibrator oooooococoococoo o 6 26 Requesting load list by date time 7 74 QC Chart 0000 9 3 9 29 9 31 9 34 Requesting load list by rack and position 7 73 QC File liSt 9 20 9 31 9 34 Requesting load list by status 7 74 QC File number 000000 eee 9 6 Rer un Dy in Sa v eve ee ee ey 7 63 7 64 QC L0G cuis dhe 9 3 9 22 9 31 9 34 A range of alphanumeric sample IDs 7 63 QC Summary elles 9 27 9 31 9 34 A range of sample IDs 0 0005 7 63 Quality control QC All sample IDs 0200000 eee 7 63 A e RE Haid beetle Renate 9 3 9 4 Individual sample IDS o o ooo 7 63 Rules RELEASE ee 9 3 Rack and positi0N oo oooooooo o 7 64 Statistics 1211 vi eL dus lle 9 3 Sample ID 3 ez i a ev te REAL 7 63 Quality control screen 0 0 0 cee eee 9 9 Rerun chem dialog box ooooooooooo 7 68 Quiet Zone yl cxlo Uy E ER BES 2 56 Rerun results Flag B seh et ele oru eir peret te t 7 61 Rerun samples dialog DOX
8. 7 62 R Rerunning original programs 7 67 Responsibility during the warranty period 1 5 Rack bar code label placement 5 118 Restore default 5 16 5 27 5 39 5 43 5 46 5 56 5 59 Rack labels 000 c eee eee 2 19 10 16 5 63 5 64 Rate determination 20 0 eee eee 3 3 Results screen 2 20 e eee ees 8 11 Rate Mode ia cc Soe ad eras a b 5 93 Reuse dilution 7 65 7 67 Rate nephelometry ooocoooooooooo 3 2 3 3 Reviewing a control definition 9 16 Rate turbidimetry 200 0055 3 2 3 3 Rul6S ud id 9 3 Laser light source nephelometric 3 2 LED light source turbidimetric 3 2 Nephelometric detector 3 2 S Reaction cuvette o ooooooooooooo 3 2 Turbidimetric detector o oooo o 3 2 Sample addition ports ooooooooooo 2 13 Reaction buffer ooooooo oo 2 4 2 5 Sample carousel 000 cee ee o 2 10 Reaction buffers 0 00 e eee eee ee 6 9 Sample carousel advance button 2 11 Reaction module 20 e eee eee 2 8 Sample carousel cover 0 0 cee eee 2 11 Reaction wheel 002 cee eee eee eee 2 9 Sample carousel status ooooooooooo 11 4 Read catds A nk Ae ae eee 6 5 Sample carousel status description Read reagents eese 6
9. 0 0 0 0 eee eee 2 45 Sample racks 0 00 cee ee eee 2 11 2 19 Sample replicates 7 10 7 29 Sample status Complete x steed es A 7 12 Incomplete ier er ore p e oe aa a eee 7 12 Not programmed sseleeleeees 7 11 RUNNING escitas Ede Uu ONES 7 11 Sample comment demographics 7 11 Sample required 0000 ee eens 7 11 Waiting torun lle 7 11 Sample syringe pump ssesesesesss 2 13 Sample type 7 10 7 20 7 25 7 38 7 45 7 46 7 70 9 6 Sample volumes Sampling template 2 00 ee eee 1 6 Scatter signal 0 0 eee eee 3 3 Scatter signal versus time for rate nephelometry and rate turbidimetry 6 coco 3 3 Scope of this manual lesse esee 1 3 Screen headings description Reagent status calibration status 6 3 Secondary aliquot tubes 2 49 Select control dialog box liess 7 41 Select clear racks dialog DOX 7 50 Selecting Text Ml cima Sew 2 36 Selecting a chemistry by number 7 18 Selecting a panel by number 7 16 Selecting a sample type ooooccccccccoo ro 7 20 Selecting an operational mode Bi directional oooo ooooomoomooo 5 54 Bi directional with host query 5 54 None ria A beet dj 5 54 Operational MOde oocococccccco 5 54 Unidirectional ooooooooooooooo 5 54 Selecting comment
10. 1 of 2 System Setup Page 5 28 IMMAGE 800 Operations Manual A11403 March 2004 Calculations Setup Units in Calculations Table 5 3 Calculations Available on IMMAGE 800 continued Calculation Chemistries Run for Formula Name Calculation ALB Index Albumin CSF and CSF ALB serum ALB serum IGG Index IGG CSF and serum CSF IGG serum IGG IGA Index IGA CSF and serum CSF IGA serum IGA IGM Index IGM CSF and serum CSF IGM serum IGM 2 of 2 Units in Calculations The units of the calculation result are the units of the first chemistry encountered in the equation Units will be converted within a calculation if the units belong in the same unit category Refer to Table 5 4 When the units in the calculation are not in the same category they cannot be converted and the calculation will be suppressed Units in Custom Calculations Changing the units of a chemistry may affect the calculation result defined with that chemistry Units will be converted within a calculation if the units belong in the same unit category Refer to Table 5 4 Enabling a Calculation The instrument status must be in Standby in order to proceed with the steps below to enable a calculation Step Action 1 From the Setup screen select lt 6 gt Calculations Refer to Figure 5 10 2 Select the button beside the calculation desired Multiple calculations can be selected 3 Sele
11. ooo o ooo 6 22 Calibration status oooocoooocooooo 6 23 B Events iaa doin Ts 6 24 MOS ii a EE 6 22 Background bar code label 2 11 CD ROM drive 0 0c cece eee eee ee 2 22 Bar code caution label 1 12 Change date 0 cece eee 5 47 Bar code parameters Change date dialog bOX o ooooooooo 5 47 Enabling check digitS 5 14 Change time 0 0 0 c eee eee 5 48 Fixed code lengthS 0 o ooooooo 5 14 Change time dialog box 24 hour format 5 48 Large intercharacter gap 5 14 Changing the displayed printed language Range lengths 0 eee eee eee 5 14 Languages keyboard 00ee eee 5 65 Start and stop codes match 5 14 Languages keyboard selection dialog box 5 65 Bar code priority 5 15 7 48 7 49 7 50 Check box es 2000 ee eee 2 33 2 36 7 30 Bar code reader 00 1 8 2 5 2 11 Checking buffer diluent status 7 8 Bar code symbologies 9e remaining ek e ath Rie par donis 6 9 B r Code iis ccd eda RM mace bald oe ine 5 13 Buffer diluent 0 0 0 c eee eee eee 6 9 Bar code setup screen 0 00 5 13 Buffer diluent status dialog box 6 10 Bar coded controls 0 0 e eee eee 7 39 Checking rack status 00000 esee 7 4 Bar coded tube orientation
12. Blue Connects wash solution box to instrument Orange vents wash solution to box 3 Waste Container Holds waste A drain can be used instead 4 Waste Tubing green Outlet for waste leading to waste container or drain IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 17 Wash Solution Box and Waste Container Wash Solution Wash Solution The wash solution is used to wash the probes mixers and cuvettes Wash Solution Box Placement The wash solution box must be close enough to the instrument to allow connection of the wash solution tubing Waste Container Placement The waste container must be placed with the opening of the waste container no higher than the top of the instrument System Description IMMAGE 800 Operations Manual A11403 Page 2 18 March 2004 Racks Description Racks Description Each sample rack holds up to nine sample tubes Each rack is bar coded to allow identification of the rack number by the instrument Refer to Figure 2 12 A012184P EPS 1 Rack Bar Code Label 2 Rack Number 3 Handle Figure 2 12 Sample Rack Types of Racks There are four types of racks They are identified by the size of sample tube that they hold Refer to APPENDIX A Part Number List 16x 100 mm e 16x 75 mm 13 x 100 mm e 13x75 mm Applying Rack Labels Refer to CHAPTER 5 System Setup Instrument Setup Placing Labels on a Rack fora detailed
13. Home AII Disable All e Sample Stir Motor Reagent Stir Motor The instrument status must be in Standby in order to proceed with the procedures described below Home All and Disable All Follow the steps below to home the system or to disable all instrument motors Step Action 1 Select Utilities from the menu bar 2 Select lt 3 gt Diagnostics OR Enter 3 in the Option No field 3 Select lt 2 gt Callable Diagnostics from the Diagnostics dialog box Refer to Figure 10 22 OR Enter 2 in the Option No field and press Enter 4 Select lt 1 gt Electro Mechanical Motion from the Callable Diagnostics screen OR Enter 1 in the Option No field and press Enter 5 Select to Call Diag F1 return to the Callable Diagnostics screen Home All F3 home the system Disable All F4 disable all instrument motors Utilities Page 10 50 IMMAGE 800 Operations Manual A11403 March 2004 Callable Diagnostics Sample Stir Motor and Reagent Stir Motor Callable Diagnostics Option No L Electro Mechanical Motion 1 2 Optics Pre Amp Board Eam Data ficquisition Board 4 Reference Cuvette 5 React ion Chamber Temperature Control 6 Reagent Chamber Temperature Control Eml Sample Bar Code Reader 8 Reagent Bar Code Reader _9 Pumps and Valves _18 Sample Stir Motor Cancel E014071S EPS Figure 10 22 Callable Diagnostics Dialog Box Sa
14. lille eee eee 6 26 Alpha 1 Microglobulin A1M 3 8 Calibration status esee 6 18 Alt Keys ere RI rexe e Ur CR 2 34 Cal failed eoe poc oes eT RI nog 6 18 ANDOY 2 esis io echoed a etapa I extre res 3 4 3 6 Cal re enabled 00 cece 6 18 Antibody excess 0 eee eee eee 3 8 Calibrated 6 2 eee eee 6 18 Antigen sil MENDA tan 3 4 Requested ooccccocoo eee 6 18 Antigen excess 3 8 3 9 3 10 5 42 7 10 7 28 7 30 Uncalibrated o oooooooooooo 6 18 7 46 7 65 Calibration time liMit o 6 34 Antigen excess screen o oooococooocoooooo 5 42 Calibrator bar code Card o oooocccoccocoo ooo 6 5 Antigen antibody reaction under varying concentrations Calibrator lot display dialog box 6 37 of antigen and antibody 3 4 Cancel eb Wis Se den Pee eres 2 37 Applying rack labels o o oooo 2 19 Canceling a chemistry lille lees 7 19 Arrow Keys cones er guru a oe Meek Oe be 2 35 Canceling a panel 0 eee eee eee 7 17 Assigned mean occ 9 6 Canceling a requested calibration 6 29 Assigned standard deviati0N 9 6 Capacities 2 0 eee 2 47 Assigning a rack and position 7 14 Cartridge bar code description 6 14 Autoclave sheds cies Raters a wee ee 10 14 Cartridge SpecifiC ooooooooooomoooo 6 22 Calibration criteria
15. 1 Check and clear as necessary e sample racks Check clear and replace as necessary e dilution segments Check e reagents buffers and diluents wash solution volume Refer to Preparing for Programming Running in this chapter 2 Request calibrations if necessary Refer to CHAPTER 6 Reagents Calibration 3 If samples are then bar coded program sample ID chemistries and any additional information needed for each sample Load samples in any rack and position not bar coded program rack and position sample ID chemistries and any additional information needed for each sample Load samples in the programmed racks and positions Refer to Programming a Sample in this chapter and CHAPTER 2 System Description Sample Container Information 4 Select Main from the menu bar AND Select Run 5 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run IMMAGE 800 Operations Manual A11403 Sample Programming Page 7 83 Host Communication Status Introduction Host Communication Status Introduction The following table explains the host communications messages displayed at the top center of the screen during a run Table 7 10 Host Communications Messages Host Setup Message Status None Host off IMMAGE 800 host communications is set for no host Unidirecti
16. 3 Type a Sample ID up to 15 alphanumeric characters a space is not allowed Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 14 March 2004 Entering Sample Identification 7 Displaying Editing a Sample Program NOTICE Every Sample ID must be unique A Sample ID can only be reused by e rerunning the sample The original and rerun results will be collated Example A sample is programmed for tests A and B Test B requires pretreatment of the sample The untreated sample can be run first for test A and the pretreated sample can then be rerun for Test B only OR clearing the Sample ID and reprogramming it The original and reprogrammed Sample IDs will be treated as two different samples Example A lab receives two different samples with identical Sample IDs One of the samples can be run first and cleared by Sample ID and the remaining sample can then be run Displaying Editing a Sample Program A previously saved sample program can be displayed by entering either the Rack and Position or the Sample ID The program can then be edited IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 15 Selecting Chemistry Tests by Panel Introduction Selecting Chemistry Tests by Panel Introduction A panel containing one or multiple chemistry tests can be selected Panels are defined by the user in Setup A panel can be selected by typing the number of the panel i
17. Step Action continued 10 Load the samples on the sample carousel 11 Select Main from the menu bar and Run 12 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run 2 of 2 UDR Rate Mode ests Remaining Cal Status 300 Uncalibrated Cancel E014049S EPS Figure 5 39 UDR Rate Mode Dialog Box Host Off Samples Results Available Racks 1 16 12 99 Enter Position Number 1 9 E014050S EPS Figure 5 40 UDR Rate Mode Assign Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 94 March 2004 Programming Rate Mode Additional Information Additional Information Refer to CHAPTER 7 Sample Programming Clearing a Sample and Requesting a Load List Refer to CHAPTER 8 Results Recall Printing Recalled Results to reprint UDR rate mode results Refer to APPENDIX C Reports for an example of a Rate Mode report IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 95 Calibrating a UDR Chemistry Introduction Calibrating a UDR Chemistry Introduction A UDR can be calibrated by using a multi point calibration Subsequently this calibration may be updated using a single point update calibration The UDR chemistry calibration using a multi point calibration or single point update requires that the protocol definition be completed and the chemistry name configured
18. Table 6 3 Calibration Status Terms Term Explanation Uncalibrated the reagent has never been calibrated Calibrated the reagent is calibrated Requested calibration is requested Cal Failed calibration failed Cal Re enabled the previous calibration is re enabled Checking On Board Reagent Cal Status Follow the steps below to check the calibration status of the on board reagent cartridges Step Action 1 Place reagent cartridges on the reagent carousel and read the cartridge bar codes Refer to Reagents Loading Unloading Reagent Cartridges in this chapter 2 Check the calibration status of the reagents from the Reagent Status Calibration Status screen under the Cal Status heading Refer to Figure 6 8 3 Select Control P to print the Reagent Status Calibration Status screen s Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 18 March 2004 Checking Calibration Status Verifying the Cal Status of Reagent Parameters in the Database Host Off eWLtymFB nu Main Samples Besults Rats Cal gc Setup Utils Status Stop F12 About Reagent Status Calibration Status 0 v testa n seriall r Pos Chem Left Lot Number Status Cal Date _ l IGG 288 309294 F959 Calibrated 02 02 2004 e TEST 16 123456 A438 Uncalibrated UDR1 n 12344BC E999 Unapproved 02 05 2004 ET SI el a el a 10 Read Reagent Buff er IS Cal Cal Read Reage
19. 1 of 2 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 15 As Indicated Maintenance Decontaminating Carousels and Racks Step Action continued 3 To remove the sample carousel unscrew the two top and two side screws 1 of the sample carousel cover Figure 10 10 4 Unscrew the sample carousel cap Remove the sample carousel Figure 10 11 5 Prepare a 10 bleach solution approximately 0 5 final hypochlorite solution in deionized water 6 Immerse carousels or sample racks into a large container or sink filled with the bleach solution Allow carousels or racks to soak at room temperature for 15 to 20 minutes 7 Remove the carousels or racks and rinse with deionized water or tap water and let stand until dry 8 Observe rack labels for bubbling peeling or fading Remove and replace with a new label if necessary according to instructions in CHAPTER 5 System Setup Placing Bar Code Label on Rack 2 of 2 Utilities IMMAGE 800 Operations Manual A11403 Page 10 16 March 2004 As Indicated Maintenance Replacing Cuvettes Replacing Cuvettes Cuvettes are clustered in sectors of three for efficient handling Handle cuvettes by the top edges only Do not remove or touch Reference Cuvette number 40 The instrument status must be in Standby in order to proceed with the steps below Step Action 1 Verify that the cuvette washer is raised into the cuvette wash
20. 4 All definitions for each chemistry calculation chosen will print Additional Information Refer to Configuring the Chemistry Menu and to Calculations Setup in this chapter for chemistry and calculations setup information System Setup IMMAGE 800 Operations Manual A11403 Page 5 24 March 2004 Report Setup Introduction Report Setup Introduction Report formats can be selected for patient reports A report header including a facility name and address can also be defined Automatic printing of calibration control and patient reports can also be enabled Defining the Report Header The report header can include the facility name and the facility address The instrument status must be in Standby in order to proceed with the steps below to define the report header Step Action 1 From the Setup screen select lt 5 gt Report Setup Refer to Figure 5 9 2 If desired type the name of the facility in the Facility Name field up to 60 alphanumeric characters 3 If desired type the address of the facility in the four Facility Address fields 4 lines of up to 60 alphanumeric characters each The default report header is blank Host Off 64 89 1998 88 25 Report Setup Report Header Facility Name Facility Address Report Format CAP Information Patient Lab Report DA ID Number Print Patient Reports v Attention erson Print Control Reports Enter facilitu name for r
21. Add Del Control Delete Ch ID E014032S EPS Figure 9 4 Define Edit Controls Dialog Box Control ID Control IDs must be part of the control definition if controls are identified by bar code on a run Each Control Name can be defined with up to eight different Control IDs The same bar coded control can be repeated in different positions during a run if a different Control ID is assigned Control IDs like Sample IDs must be unique for each sample within a run Control IDs unlike Sample IDs can be reused without being cleared after the control sample is run Results from all Control IDs for a chemistry are collected under the same Control Name Quality Control IMMAGE 800 Operations Manual A11403 Page 9 10 March 2004 Defining a Control Assigning Control ID Assigning Control ID After entering the minimum information to define a control follow the steps below to further define a control Step Action 1 From the Define Edit Control screen select Control ID F2 2 AN CAUTION When creating Contro IDs use a format that is distinctly different from Sample IDs This will prevent the reporting of erroneous results due to controls being run as patient samples or patient samples being run as controls The Control ID dialog box will display Up to eight unique IDs each with a maximum of 15 alphanumeric characters may he entered Press Tab Enter or use the arrow keys after each bar
22. Figure 8 1 Thru Post s Lastname Firstname mer zl ENS Sen F4 Recall Results Screen 2 of 2 Stop F12 Middle E014099S EPS Results Recall Page 8 4 IMMAGE 800 Operations Manual A11403 March 2004 Recalling Results by Rack and Position Introduction Recalling Results by Rack and Position Introduction Results can be recalled by Rack and Position Recalling by Rack and Position Follow the steps below to enter Rack and Position for recall Step Action 1 Select Results from the menu bar Refer to Figure 8 1 2 Type the rack number s desired for recall in the Rack s field up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range If then one rack number is entered Press Enter to access the Pos s field Type the position numbers desired for recall up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack number All positions on each rack are is entered automatically selected The Pos s field cannot be accessed Select the options button lt W gt beside the Data Source field Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall res
23. System Description IMMAGE 800 Operations Manual A11403 Page 2 54 March 2004 Sample Volume Minimum Volumes Sample Volume Minimum Volumes Refer to the IMMAGE Sampling Template for minimum volume requirements Primary Tube Sampling Template Before running a primary tube on the IMMAGE 800 verify sample tube volume level with the IMMAGE Sampling Template IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 55 Loading Tubes Into Racks Guidelines Loading Tubes Into Racks Guidelines Remove stoppers from sample tubes before loading Load the sample tubes onto the racks with the bar code labels facing the same direction as the sample rack bar code label Refer to Figure 2 25 Confirm that the tube is properly seated in the bottom of the rack Be sure the entire bar code symbol including quiet zone is visible through the rack Example 1 Figure 2 25 not be identified or run NOTICE The bar code must be visible to the Sample Bar Code Reader otherwise the sample will Rack Bar Code Label Bar Coded Tube Orientation A010099P EPS System Description Page 2 56 IMMAGE 800 Operations Manual A11403 March 2004 Instrument Operation Introduction Instrument Operation Overview Instrument Operation Introduction The following tables describe instrument functions during start up sample processing and data reduction Start up The following
24. A user defined warning message appears Read the message and select lt OK gt Select the AGXS Enable box Enter Rate Units into AGXS Limit field Select Save F9 If your password is protected then refer to the Password Setup Procedure in this chapter and enter your user name and password 8 Select lt OK gt W alalu pA Defining UDR Sample Reagent Volumes The minimum total cuvette volume of reagent s and sample is 195 uL The maximum total cuvette volume of reagent s and sample is 365 uL The instrument status must be in Standby in order to proceed with the steps below to define UDR sample and reagent volumes Refer to Figure 5 33 Step Action 1 From Page 2 of the Define Edit User Defined Chemistry screen select the Buffer options button beside the Buffer field 2 Select the buffer type from the list Select the Diluent options lt V gt button beside the Diluent field 4 Select the diluent type from the list 1of3 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 81 Defining a UDR Chemistry Defining UDR Sample Reagent Volumes Step Action continued 5 Enter the volume of sample or sample dilution to be aspirated and dispensed in the Sample or Dilution Volume field If the Sample Dilution field the Sample or Dilution Volume entry is field may be 1 5 to 1 50 3 uL to 75 uL 1 1 undiluted
25. Cumulative Mean 73 72 Cumulative SD 2 789 Comments Constituent Code 28 Cumulative Mean 137 4 Cumulative SD 10 20 Comments Constituent Code Cumulative Mcan 124 8 Cumulative SD 7 720 Comments E014109L EPS QC Log Report Reports Page C 18 IMMAGE 800 Operations Manual A11403 March 2004 Introduction QC Log by Reagent Lot QC Log by Reagent Lot IMMAGE S N PPI2 17 04 24 1998 09 18 39 PAGE 1 QC LOG REPORT Beckman Coulter Inc 200 S Kraemer Bivd Brca CA 92622 8000 B00 854 3633 Control Name VIGIL PRX L1 Start Date 04 01 1998 Lot Number M612142 End Date 04 24 1998 Sample Type Serum QC File Number constituent Code Assigned Mean 0 000 Cumulative Mean 78 29 Assigned 1 SD 99999 Cumulative SO 32 01 Reagent Lot Number M610013 Date i Result i Comments 04 23 1998 118 04 23 1998 116 04 23 1998 E 112 04 23 1998 117 04 23 1998 104 04 23 1998 100 04 23 1998 98 04 23 1998 f 105 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 ca QC File Number constituent Code 024 Assigned Mean 50 30 Cumulative Mean 41 26 Assigned 1 SD 5 050 Cumulative SD 2 206 Reagent Lot Number M706055 Date Time Result Units Flag Comments 04 23 1998 14 53 09 218 mg dL DELETES 04 24 1998 99 16 is poured wrong control 04 23 1998 14 52 49 mg dl DELETCD 04 24 1998 09 16 dis poured wrong contro 04 23 1998 14 52 39 mg dl DELCTED 04 24 1998 09 16 ji
26. IMMAGE 800 Operations Manual A11403 March 2004 Selecting Introduction Selecting Non Standard Dilutions 7 Introduction Non Standard Dilutions A Non Standard Dilution can be selected for an individual chemistry from a pre defined list The list contains Non Standard Dilutions that are specific for each chemistry The default starting dilution is indicated as selected when the Non Standard Dilutions screen is first displayed Refer to Figure 7 8 When a Non Standard Dilution is selected for a chemistry I it is used as the starting dilution for the chemistry it applies only to the chemistry for the current sample it is displayed beside the chemistry on the Sample Options dialog box it will remain selected if the Non Standard Dilution dialog box is displayed again for the same sample f antigen excess testing is enabled for a chemistry it will still be performed when a Non Standard Dilution is selected Sample programming from a host computer assumes the default starting dilution for each chemistry A Non Standard Dilution can be selected by editing the sample program before the run begins Alternatively a Non Standard dilution can be programmed to be the default starting dilution Refer to CHAPTER 5 System Setup Selecting Non Standard Dilutions as Default for Each Chemistry This would allow S ample programming from the host computer to begin at a dilution defined by the user A Non Standard Dilution
27. Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack number is entered All positions on each rack are automatically selected The Pos s field cannot be accessed 4 Select a button from the bottom of the dialog box IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 73 7 Requesting a Load List Requesting Load List by Date Time Requesting Load List by Date Time Follow the steps below to request a Load List by Date Time Step Action 1 Select Load List F9 from the Program Sample screen 2 Type the desired date and time ranges in the From fields and To fields Refer to Table 7 9 for a description of the Date Time field entries 3 Select a button from the bottom of the dialog box Table 7 9 Date Time Field Descriptions Field Entries Notes Date From mm 1 12 f only a From date is entered and To dd 1 31 the load list be requested for yy 0 99 the 24 hour period of that date The order and the separator character are defined in Setup Time From hh 1 12 A time entry is optional If and To 12 mm 0 59 only a date is entered the load hour format list will be requested for the AM PM each 24 hour period in the date Select the options button
28. Observe Status Monitor 2411 Reference Voltage Out of Range High WARNING Observe Status Monitor 2416 5 Volt Power Supply E Out of Range Low WARNING Observe Status Monitor 2417 5 Volt Power Supply E Out of Range High WARNING Observe Status Monitor 2418 12 Volt Power Supply Out of Range Low WARNING Observe Status Monitor 2419 12 Volt Power Supply Out of Range High WARNING Observe Status Monitor 2420 Negative 12 Volt Power Supply Out of Range Low WARNING Observe Status Monitor 2421 Negative 12 Volt Power Supply Out of Range High WARNING Observe Status Monitor 2422 24 Volt Power Supply D Out of Range Low WARNING Observe Status Monitor 2423 24 Volt Power Supply D Out of Range High WARNING Observe Status Monitor 2424 24 Volt Power Supply E Out of Range Low WARNING Observe Status Monitor 18 of 21 Utilities Page 10 40 IMMAGE 800 Operations Manual A11403 March 2004 Table 10 7 Errors Error Table Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 2425 24 Volt Power WARNING Observe Status Monitor Supply E Out of Range High 2426 24 Volt Power WARNING Observe Status Monitor Supply H Out of Range Low 24
29. 2 Select the options button lt W gt beside Timeout Value to enter the Timeout Value dialog box 3 Select the number next to one of the timeout values below 1 1 minute lt 2 gt 2 minutes lt 3 gt 4 minutes lt 4 gt 7 minutes lt 5 gt 10 minutes OR Select lt Cancel gt to exit the Timeout Value dialog box without selecting an timeout value Enabling Disabling Auto Send Results If Auto Send is enabled results are sent to the LIS automatically No additional actions are required to send the results If the Auto Send is disabled the results must be approved and sent to the LIS from the Recall Results By screen Refer to CHAPTER 8 Results Recall The instrument status must be in Standby in order to proceed with the steps below to enable or disable auto send results Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the check box next to Auto Send Results to enable auto send OR Deselect the check box to disable auto send System Setup IMMAGE 800 Operations Manual A11403 Page 5 52 March 2004 Host Communications Setup Enabling Disabling Error Display Mode Enabling Disabling Error Display Mode When fatal errors are generated there is a problem with transmission to or from the host system If the error display mode is enabled these errors will be displayed on the screen If the error display mode is disabled t
30. 4 and shear valves 5 Refer to operations fluid leaks Figure 10 3 Bubbles may be removed by gently tapping on or bubbles are present the tubing or syringe during the prime function Refer to As Indicated Maintenance in this section for syringe replacement f A010024PEPS Figure 10 3 2 of 2 Cleaning Instrument Parts The instrument status must be in Standby in order to proceed with the steps below to clean the reagent sample probes and mixer paddles Step Action 1 Raise reagent sample crane probe covers as shown A010039P EPS Figure 10 4 1 of 2 Utilities Page 10 10 IMMAGE 800 Operations Manual A11403 March 2004 Daily Maintenance Procedures Priming Step Action continued 2 Carefully wipe probe and mixer the full length exposed with an alcohol swab s Figure 10 5 3 Lower probe covers 2 of 2 Priming To prime perform the following steps Step Action 1 Select Utilities from the menu bar 2 Select lt 1 gt Prime from the Utilities dialog box OR Type 1 in the Option No field and press Enter Enter number of primes desired 4 Select lt OK gt IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 11 Monthly Maintenance Procedures Monthly Monthly Maintenance Procedures Monthly The following table lists the scheduled monthly maintenance for the IMMAGE 800 System Ta
31. 854 3633 Control Name PRX PRX PRX NNNNNNNNNNNNNNNNNNANNNND QC File List by QC File Number M612142 M612142 M612142 M612142 M612142 M612142 M612142 M612142 M612142 M612142 Mel2142 M612142 M i2142 M612142 M612142 M612142 M612142 M612142 M612142 M612142 Me12142 M612142 M612142 04 27 1998 14 34 33 PAGE 1 E014107L EPS Reports Page C 16 IMMAGE 800 Operations Manual A11403 March 2004 QC File List by Chemistry Name IMMAGE S N PPI2 17 VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL VIGIL aoc FILE LIST BY CHEMISTRY NAME Bockman Coulter Inc 200 S Kraemer Bivd Brea CA 92622 8000 8000 854 3633 M612141 M612141 M612141 M612141 M612141 M612142 M612141 M612141 M612141 M612141 M612141 M612141 M612141 M612141 M612141 M612141 Me12141 M612141 M612141 M612141 M612141 M612141 M612141 Figure C 16 QC File List by Chemistry Name Introduction QC File List by Chemistry Name 04 27 1998 15 52 47 PAGE 1 E014108L EPS IMMAGE 800 Operations Manual A11403 March 2004 Reports Page C 17 Introduction QC Log Report QC Log Report IMMAGL S N PPI2 17 Control Name Lot Number Sample Type VIGIL PRX L2 M612124 Serum 2 QC File Number Assigned Mean Assigned 1 SD Date 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 199
32. CALL BECKMAN COULTER Buffer Overflow CLINICAL SUPPORT Error 1215 Cuvette Selected FATAL CALL BECKMAN COULTER for Opportunistic CLINICAL SUPPORT Wash is Out of Range 1216 Cuvette Selected FATAL CALL BECKMAN COULTER for Preferred CLINICAL SUPPORT Wash is Out of Range 1217 Preferred Wash FATAL CALL BECKMAN COULTER Selection Error CLINICAL SUPPORT 1218 Bad Return FATAL CALL BECKMAN COULTER Status for CLINICAL SUPPORT Preferred Wash 11 of 21 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 33 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 1219 Cycler Timed FATAL CALL BECKMAN COULTER Out on Scheduler CLINICAL SUPPORT Stop 1220 Dilution Handler FATAL CALL BECKMAN COULTER Return Code CLINICAL SUPPORT Error 1223 Error Reporting FATAL CALL BECKMAN COULTER Wash Complete CLINICAL SUPPORT Status 1227 Received WARNING CALL BECKMAN COULTER Unexpected CLINICAL SUPPORT Level Sense Notification 1228 Received WARNING CALL BECKMAN COULTER Unexpected CLINICAL SUPPORT Level Sense Failure Notification 1601 OMT Detected WARNING Verify instrument is in proper mode Invalid Request for functions selected e g Standby 1602 Optics Check WARNING Will STOP CALL BECKMAN COULTER Nia Offset Run CLINICAL SUPPORT Quality High 1603 Optics Check
33. Diagnostic routines initiated by the user from the software CAP information Information consisting of an ID number and a designated laboratory contact person based on the College of American Pathology standard Check digit A character which is used to mathematically check that a bar code is read accurately Chemistry list The comprehensive list of all chemistries with protocols loaded into the system Chemistry menu The collection of chemistries configured by the user from the chemistry list for display selection in sample programming and panel configuration Code length A parameter which may be defined by the user so that only one bar code length will be accepted Glossary IMMAGE 800 Operations Manual A11403 Page 2 of 6 March 2004 Constituent code Constituent code A quality assurance program code that can be defined for a control chemistry Control ID The equivalent of a Sample ID for a control Up to 8 unique Control IDs can be defined for each Control Name Conversion factor The value that a user may define to apply to a result to convert from one category of units to another Critical range A user defined range consisting of low and high values that are used to flag patient results as critical low or critical high Cuvette One of the receptacles on the IMMAGE 800 reaction carousel in which sample and reactants are mixed and the reaction is measured DAS Data Acquisition Software Data
34. If the system has returned to a Standby status a new run must be started Several options are available when rerunning samples The original sample programs can be edited before rerunning The original sample programs can be rerun Selected chemistries can be rerun for a group of samples The initial dilution made in the dilution well can be reused The default is to remake a dilution Rerun Results When tests are rerun The rerun results replace the original results Rerun results are indicated by a flag R on the Laboratory Report After a sample is rerun all results will be collated on the result report IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 61 Selecting Samples to be Rerun Introduction Selecting Samples to be Rerun Introduction Samples can be selected for rerunning by Sample ID and or a range of Sample IDs or by Rack and Position Refer to Figure 7 19 Rerun Samples By Range Thru Rack s Pos s Edit Rerun Rerun Cancel Samples Samples Chems E010267S EPS Figure 7 19 Rerun Samples Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 62 March 2004 Selecting Samples to be Rerun 7 Rerunning by Sample ID Rerunning by Sample ID Follow the steps below to enter Sample IDs for rerun Both individual Sample IDs and a range of Sample IDs can be entered Step Action 1 Select Rerun Samples F6 from the Program
35. Kraemer Boulevard California 92822 8000 File Number 04 27 1998 14 5 amp 37 PAGC 1 Start Date 04 01 98 End Date 04 27 98 Constituent Code E014111L EPS Reports Page C 20 IMMAGE 800 Operations Manual A11403 March 2004 QC Summary Report IMMAGE S N PPI2 17 Control Name Lot Number Sample Type File No 0S1 032 033 034 VIGIL PRX L3 M612143 QC SUMMARY REPORT Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92622 8000 800 854 3633 Figure C 20 QC Summary Report Start Dat End Date 64 23 1998 18 23 16 PAGE 1 94 01 1998 04 23 1998 Introduction QC Summary Report E014112L EPS IMMAGE 800 Operations Manual A11403 March 2004 Reports Page C 21 Introduction Inter Lab QC Summary Report Inter Lab QC Summary Report IMMAGE S N PPI2 17 Control Name Lot Number Sample Type Figure C 21 04 23 1998 18 22 44 PAGE 1 INTER LAB QC SUMMARY REPORT Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92622 8000 8005 854 3633 ATTN Ms Mary Jane Smith ID 12345 6789 VIGIL PRX L3 M612143 Actual 82 34 263 2 Inter Lab QC Summary Report Assigned Start Date End Date 04 01 1998 04 23 1998 Assigned 99999 25 00 99999 0 000 280 0 0 000 E014113L EPS Reports Page C 22 IMMAGE 800 Operations Manual A11403 March 2004 Introduction Event Error Log Event Error Log IMMAGE S N PPI1_9 07 18 1996
36. Reagent Cartridges Compartments A and B Figure 2 3 The Reagent Compartment NOTICE The instrument will stop if the reagent compartment cover is opened System Description IMMAGE 800 Operations Manual A11403 Page 2 4 March 2004 Component List Reagent Compartment Component List The following table lists each component of the reagent compartment with its function Table 2 1 Reagent Compartment Components Number Component Function 1 Reagent Compartment Necessary to maintain temperature within Cover compartment 2 Reagent Carousel Holds up to 24 reagent cartridges and 4 reaction buffer bottles 3 Reaction Buffer Contain reaction buffers Bottles 4 Bar Coded Reagent Contain chemistry specific reagent including Cartridges where applicable Reagent AGXS antigen excess Solution Co reagent Conjugate Evaporation Caps The cartridges are bar coded to allow for instrument identification of each cartridge 5 Reagent Bar Code Reads bar codes on reagent cartridges Reader 6 Fans Circulate cool air in reagent compartment 7 Peltier Temperature Helps control 15 C in reagent compartment Sensor IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 5 Reagent Crane Description Reagent Crane Description The reagent crane transfers reagents and buffers from the reagent compartment to the reaction wheel Refer to Figure 2 4 A010098
37. Select Cancel F10 to exit the screen without saving any calibration programs 9 Repeat Steps 1 7 to program additional racks for calibration of other UDR chemistries System Setup IMMAGE 800 Operations Manual A11403 Page 5 98 March 2004 Calibrating a UDR Chemistry Requesting a UDR Cal Load List Standby Host Off 62 69 2864 13 26 emt Es E E Main Samples Results Utils Status Stop F12 About UDR Cal Assi Single Point Update vi Level 1 Chem Name UDRL imr Level 3 fivailable Racks 1 18 13 26 28 98 Level 4 Level 5 Level 6 Level 7 Level 8 LILIEIE 0000 A Level 9 Clear UDRCal Cancei Cle UDR Save Cancel Racks LdList 8e qusst CalRack Fi F6 7 F8 F9 F18 E011421S EPS Enter Rack Number 1 99 Figure 5 43 UDR Cal Assign Screen Requesting a UDR Cal Load List The instrument status must be in Standby in order to proceed with the steps below to request a UDR load list Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select UDRCal LdList F6 Refer to Figure 5 44 2 Select Print F10 to print the load list or UDRCal F9 to return to the UDR Cal screen Refer to APPENDIX C Reports for an example of a Calibration Load List IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 99 Calibrating a UDR Chemistry Running the UDR Calibration Standby Host Off 92 89 2004 11 38 E011
38. Surgical blade Utilities Page 10 4 IMMAGE 800 Operations Manual A11403 March 2004 Maintenance Precautions Introduction Maintenance Precautions Introduction To ensure the safe operation of the IMMAGE 800 and the safety of the operator please follow the precautions listed below Precautions 1 Do not remove or install a circuit board connect or disconnect any plug or cable while the power cord is connected 2 Always use the antistatic wrist strap located behind the front panel when handling any circuit board 3 Observe procedures pertaining to safe handling of biological hazards while performing system maintenance or repair 4 Theinstrument status must be in Standby before attempting to clean any part of the instrument 5 Keep clear of all mechanical assemblies when booting up the system or when exiting the Diagnostics function AN CAUTION Sodium Azide preservative in diagnostic reagents may react with lead or copper in drain lines and form explosive compounds Means of decontamination and control are described in Current Intelligence Bulletin Explosive Azide Hazard August 16 1976 prepared by the National Institute for Occupational Safety and Health A copy may be obtained from your Beckman Coulter Sales and Service Office IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 5 Maintenance Schedule Introduction Maintenance Schedule Introduction Follow the schedul
39. WARNING Will STOP CALL BECKMAN COULTER Nia Range Run CLINICAL SUPPORT Quality High 1604 Optics Check WARNING Will STOP CALL BECKMAN COULTER Nia Range High Run CLINICAL SUPPORT 1605 Optics Check WARNING Will STOP CALL BECKMAN COULTER Nia Range Low Run CLINICAL SUPPORT 1606 Optics Check WARNING Will STOP CALL BECKMAN COULTER Lpia Offset Run CLINICAL SUPPORT Quality High 1607 Optics Check WARNING Will STOP CALL BECKMAN COULTER Lpia Range Run CLINICAL SUPPORT Quality High 12 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 34 March 2004 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 1608 Optics Check WARNING Will STOP CALL BECKMAN COULTER Lpia Range High Run CLINICAL SUPPORT 1609 Optics Check WARNING Will STOP CALL BECKMAN COULTER Lpia Range Low Run CLINICAL SUPPORT 1610 Optics Check WARNING Will STOP CALL BECKMAN COULTER Too Much Optics Run CLINICAL SUPPORT Data 1611 Optics Check WARNING Will STOP CALL BECKMAN COULTER Optics Check Run CLINICAL SUPPORT Not Done 1612 OMT Detected WARNING CALL BECKMAN COULTER Invalid Barcode CLINICAL SUPPORT Setup 1613 Offline Sequence FATAL CALL BECKMAN COULTER has Timed Out CLINICAL SUPPORT 1614 Cannot Start Run WARNING Verify that volume in external wash Internal Wash solution container is su
40. usse rai 2 24 Define PrtName 0 2 cee eee eee 5 7 COMPUTET is ides etm eb lee 2 21 2 22 Defining the patient report format Computer keyboard connection 1 10 Lab rep rtiu s iro Ru e REESE 5 26 Computer mouse connection 1 10 Lab report dilutionS o 5 26 Computer power SWitCh oo o ooo o o 1 9 Patient chartable reports 5 26 Conjugate 0 E e e eee 3 6 Defining the report header Conjugate antibody ooooooooooo 3 6 Facility address fields 5 25 Connection between computer and monitor 1 11 Facility name field o o o 5 25 Connection between computer and printer 1 10 Report setup screen llle else 5 25 Constituent code ssls lessen 9 13 Deleting a chemistry llle 5 6 Continuous numbering mode 5 53 Deleting calibrator parameters 6 37 Control chemistries o 7 38 7 39 Deleting data from a text field Control lD 7 38 7 42 9 10 9 13 Backspace cido Eke a poke 2 38 Controlname 1 6 eee 9 6 Delete olet Se Wee d eed we 2 38 Control pending eese 7 38 Deleting from define edit controls screen Control sampletype lslsleesesssn 7 20 Define edit 0 2 cee eee ee ee 9 19 Copy to disk 10 45 10 46 10 47 Delete control o oooooooo
41. 0 9999 0 The result is multiplied by the slope then the offset is added or subtracted Entering Slope and Offset Adjustment The instrument status must be in Standby in order to follow the steps below to enter Slope and Offset Adjustment Step Action 1 Select Rgts Cal from the menu bar Select Cal Options F5 Select lt 2 gt Slope Offset Adjustment Select the Slope or Offset field beside the chemistry desired Type the slope and or offset number in the Slope and Offset fields Nin By wl vw Select an icon from the menu bar to save the slope offset number and go to another screen Restoring Default Slope and Offset Adjustments The instrument status must be in Standby in order to follow the steps below to restore the default slope and offset adjustments Step Action 1 From the Slope Offset screen select Restore Default F1 2 Select lt OK gt to restore all the defaults The default for each slope is 1 000 and each offset is 0 000 OR Select lt Cancel gt to return to the Slope Offset screen without restoring the default Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 38 March 2004 Cal Options Printing Slope and Offset Adjustments Printing Slope and Offset Adjustments From the Slope Offset screen select Print F10 to print all of the slope and offset adjustments IMMAGE 800 Operations Manual A11403 Reagents Calibration March
42. 1 Select Clear Samples F7 from the Program Sample screen 2 To enter type individual Sample IDs the Sample IDs to be cleared in the Sample ID s field up to 42 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric the individual Sample IDs to be cleared Sample IDs in the Sample IDs field separated by a comma all Sample IDs 0 in the Range field Press Enter Type Zzzzzzzzzzzzzzz in the Thru field 3 Select OK Select OK again to confirm the Sample IDs or Cancel to return to the Clear Samples dialog box OR Select Cancel to return to the Program Sample screen without clearing samples Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 78 March 2004 Clearing a Sample by Rack and Position Clearing by Rack and Position Clearing a Sample by Rack and Position Clearing by Rack and Position Follow the steps below to enter Rack s and Position s to be cleared Step Action 1 Select Clear Samples F7 from the Program Sample screen 2 Type the rack number s desired to be cleared in the Rack s field up to 15 characters Numbers can be separated by a comma as a series and or by
43. 2004 Approving a Calibration Introduction Approving a Calibration Introduction After the calibration run the instrument response IR for each calibrator replicate is generated The IR versus calibrator set point concentration as well as curve fit is displayed as a plot using various curve fit models The calibration model can be selected for the UDR The model and associated calibration parameters are saved for the reagent lot numbers defined for this UDR or until another calibration is requested The four models available are First Order Polynomial Second Order Polynomial Third Order Polynomial and Four Parameter Logistic Curve Fit Model Descriptions The following table describes the four curve fit models Refer to Figure 5 47 to Figure 5 53 Table 5 14 Curve fit Models Model Minimum number Formula Parameter of calibrator levels Displayed to plot graph First Order 4 A Polynomial B Second Order 5 gt A A011364L EPS C Third Order 6 A A011365L EPS C D Four Parameter 6 A Logistic B C D IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 103 Approving a Calibration Curve Fit Model Descriptions UDR1 First Order Polynomial Calibration R2 y Select Model Fi E014056S EPS Figure 5 47 Example of First Order Polynomial Calibration Host Off E i I n s t r u m e n t 1358 R e s iy o n s e E01
44. 2004 Page 6 39 CHAPTER 7 Sample Programming Table of Contents Preparing for Programming Running eese eene nennen enne ernst nennen 7 3 QVOLVIBW GS A ep A Euer d c Kasse De ocius cdeas dade 7 3 Checking and Clearing Sample Racks quas leen e oor is 7 4 Checking Status and Clearing Replacing Dilution Segments eee 7 6 Checking Reagents Buffers and Diliehits AOS 7 8 Checking Wash Solution Volume 5 5 5 2 tette iade ee tese d eeu e tacos ed eo Ra edu toad ede aeg 7 9 Programmis A er x datis qe eene Beas V etu La daten A EON RD AEG 7 10 OVA M ELE 7 10 PROCLAIM AO E A sese DUE Tete satu Gaede aC ee ae as 7 11 Entering Sample Identification Etica 7 14 Selecting Chemistry Tesis by Panel a e A E NE 7 16 Selecting Chemistry Tests by Chemistry 2 accsajanuessaderscansesy bes sade sthesnsaveguediasancesadeaseadsersboasae 7 18 selecung a Sample Type iii s n a a E a a 7 20 Entering a ample Commenters ostio GER IU oett dd mu ue OE Ro NE PUR 7 22 IN 7 24 Entering Patient Demographics ui de 7 25 Selecting Sample Options AR 7 28 Selecting Replicates a VM URDU 7 29 Antigen Excess CAGAS Lesiones dig ica bee 7 30 Selecting Non Standard Dilutions 5 dette ioc een nece tte eto tote saceatescdenes sedo toa PR aeo 7 31 Brienne an OFF line Diluton Factor ones SER AN OR E hhisdut ceu eui rd dott teg 7 33 Linkimg Unlimkitg Samples O qos e prp iA A 7 35 seting Variables a eso bod bends eve e nus M eee
45. 2004 Page C 13 Introduction User Defined Calibration Report User Defined Calibration Report IMMAGE S N 123 04 22 1998 08 14 44 PAGE 1 USER DEFINED CALIBRATION REPORT CHEM UDRI REAGENT SERIAL NUMBER A056 UDR BUFFER BUF10 L123456 RGT POS 2 REAGENT LOT NUMBER M804052 UDR DILUENT DIL10 L678901 MEAN INST RACK POS RESP 0 135 0 548 5 17 21 3 96 2 127 163 Qt pPO OU D UDRl CALIBRATED 04 21 1998 13 03 MODEL Four Parameter Logistic Calibration INSTRUMENT RESPONSE LOW 0 130 INSTRUMENT RESPONSE HIGH 168 0 595709 1 830002 171 291351 221 614227 E014064L EPS Figure C 13 User Defined Calibration Report Reports IMMAGE 800 Operations Manual A11403 Page C 14 March 2004 Introduction QC File List by Control Name QC File List by Control Name IMMAGE S N PPI2 17 04 27 1998 14 32 05 PAGE 1 Qc FILE LIST BY CONTROL NAME Beckman Coulter Inc 200 S Kraemer Bivd Brea CA 92622 8000 800 854 3633 VIGIL PRX L1 M612141 E014106L EPS Figure C 14 QC File List by Control Name IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 15 Introduction QC File List by QC File Number QC File List by QC File Number IMMAGE S N PPI2 17 058 059 060 661 062 063 064 065 066 0267 068 069 070 071 072 073 074 075 076 077 078 079 Dao Figure C 15 QC FILE LIST BY QC FILE NUMBER Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92622 8000 800
46. 3 uL to 21 uL NOTICE Aspiration of neat serum and or plasma sample volumes greater than 15 uL may result in carryover and is not recommended 6 Enter the reaction buffer volume to be aspirated and dispensed in the Reaction Buffer Volume field Entries may be 0 or from 195 uL to 300 uL 7 Enter the volume of reagent to be aspirated and dispensed from Compartment A in the Compartment A Volume field Entries may be from 5 uL to 235 uL 8 Enter the volume of reagent to be aspirated and dispensed from Compartment B in the Compartment B Volume field If the Reaction Buffer the Compartment B Volume Volume field entry is field entry may be 0 195 uL to 235 uL 195 uL to 300 uL 0 or 5 uL to 235 uL 9 Enter the gain in the Gain field Entries may be 1 2 3 or 4 The gain increases as the number increases 10 Enter the calibration dilution in the Cal Dilution field Entries may be from 1 5 to 1 50 OR Enter 1 1 for an undiluted sample The Sample Dilution field automatically displays the same value as the Cal Dilution field No input is allowed until after calibration and approval 2 of 3 System Setup IMMAGE 800 Operations Manual A11403 Page 5 82 March 2004 Defining a UDR Chemistry Defining UDR Sample Reagent Volumes Step Action continued 11 After calibration and approval if the desired sample dilution is different from the calibration dilution enter the s
47. 30 March 2004 Calculations Setup Selecting Urine Chemistries for Excretion Rate Calculations Selecting Urine Chemistries for Excretion Rate Calculations After the excretion rate calculation is enabled the urine chemistries for the calculation must be enabled Once enabled the excretion rate calculation will utilize the hours and volume entered for the urine sample When the instrument status is in Standby proceed with the steps below to enable urine chemistries for excretion rate calculations Step Action 1 2 From the Setup screen select lt 6 gt Calculations Refer to Figure 5 10 Select Select TUrine F2 Refer to Figure 5 12 3 Select the check box beside the urine chemistry desired for the excretion rate calculation The default is disabled unchecked Select lt OK gt to return to the Calculations Summary screen OR Select lt Cancel gt to return to the Calculations Summary screen without changing the urine chemistry definition Define Timed Urine Chemistries Chemistry AIM MA IGU TRU KAP LAM Enable Chemistry Enable Chemistry Enable Restore Default OK Cancel E010307S EPS Figure 5 12 Define Timed Urine Chemistries Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 31 Calculations Setup Selecting Units for Excretion Rate Calculations Selecting Units for Excretion Rate Calculations The instrument status must b
48. 800 Operations Manual A11403 Utilities March 2004 Page 10 45 Event Log Displaying Events Table 10 10 Event Log Option Numbers Option Number Event Log 1 Input Device Events 2 Database 3 Printer 4 Reagent Load 5 QC 6 System Sample Status 7 Calibration Results 8 Results 9 Maintenance Diagnostics 10 Console 11 Motion 12 Status Monitor 13 Instrument 14 LIS Errors 15 LIS Data Stream Displaying Events After selecting the desired Event Log follow the steps below to display the events Step 1 Action Select lt 2 gt Event Log from the Utilities dialog box 2 Select the desired option number s OR Type the option number s in the Option No field and press Enter Select Display Events F1 from the Event Log Screen Refer to Figure 10 19 To transfer information to diskette select lt Copy to Disk gt from the Display Events dialog box and follow the steps under Copying to disk To print the information select lt Print gt If finished viewing displayed information select lt Close gt Utilities Page 10 46 IMMAGE 800 Operations Manual A11403 March 2004 Event Log Copying to Disk Tine Description 82 19 1996 14 09 KEY Display Events 82 19 1996 14 09 KEY 82 19 1996 14 89 KEY Close 82 19 1996 14 89 KEY Display Events 62 19 1996 14 88 KEY 62 19 1996 14 88 KEY 82 19 1996 14 88 KEY 82 19 1996
49. AGE DRAW DATE 07 23 1996 BIRTH DATE DRAW TIME 00 00 SEX Male Female SAMPLE COMMENT DOCTOR LOCATION PATIENT COMMENT CHEMISTRY CALCULATION RESULTS REMARKS REFERENCE INTERVAL IGG 694 1618 IGA 68 378 IGM A 60 263 ca 88 201 ca 16 47 0 INSTRUMENT CODES E010310L EPS Figure C 1 Patient Chartable Report Reports Page C 2 IMMAGE 800 Operations Manual A11403 March 2004 Introduction Control Report Control Report IMMAGE S N PPIZ 15 04 27 1998 15 39 48 P GE 1 BECKMAN INSTRUMENTS INC 200 S KRAEMER BLVD BREA CALIFORNIA 92622 8000 Serum CONTROL ID V 1 RACK POS 2 2 SAMPLE TYPE CONTROL LOT M7D1221 RUN DATE TIME 04 23 1998 13 47 OFF LINE DIL CONTROL RANGE REMARKS 1 100 2 180 M802222 1 100 2 180 Ma02222 E014102L EPS Figure C 2 Control Report IMMAGE 800 Operations Manual A11403 Reports Page C 3 March 2004 Introduction Laboratory Report Laboratory Report IMMAGE S N PPI1 9 BECKMAN INSTRUMENTS 200 S CALIFORNIA 92622 8000 BREA RACK POS 3 4 SAMPLE TYPE Serum RUN DATE TIME 07 18 1996 10 17 OFF LINE DIL RESULTS UNITS CHEM IGG IGA IGM ca c4 SAMP COMMENT INSTRUMENT CODES Figure C 3 Laboratory Report 07 18 1996 12 58 13 PAGE 1 INC KRAEMER BLVD PATIENT ID REFERENCE INTERVAL REMARKS E010312L EPS Reports Page C 4 IMMAGE 800 Operations Manual A11403 March 2004 Introduction Laboratory Repor
50. Always use the antistatic wrist strap located in the electronic board compartment when removing or installing any circuit board Do not place containers holding liquid on top of the instrument If a spill occurs liquid may get into the instrument and damage electrical or mechanical components Safety Against Risk of Fire Fuses protect certain electrical circuits within this instrument against overcurrent conditions For continued protection against the risk of fire replace only with the same type and rating specified IMMAGE 800 Operations Manual A11403 Safety Notice March 2004 Page 1 of 2 Mechanical Safety Mechanical Safety For safe operation of the equipment observe the following Operate the system with reagent door and covers and shields in place During power up routine operation and diagnostic procedures keep hands and or foreign objects out of the path of the carousels and probes Do not attempt to clean around the carousels and probes while they are in motion Wait until the instrument is in standby to perform cleaning procedure Chemical and Biological Safety Normal operation may involve the use of solutions and test samples that are pathogenic or infectious Observe all laboratory policies or procedures which pertain to the handling of these materials The reagents and other chemical preparations used with the system will not normally cause adverse reactions however those persons with sensitive s
51. Areas dialog box OR Enter 11 in the Area No field and press Enter Select 1 Optics from the Alignment dialog box OR Enter 1 in the Procedure No field and press Enter Complete Steps 1 3 as described on the screen selecting Continue after performing each step OR Select Stop to exit Select Close to return to the Alignment screen or select Repeat to restart the alignment procedure Select Yes from the Alignment dialog box to save the alignment data to a temporary file OR Select No to return to the Alignment Optics screen without saving the alignment data Select an icon from the menu bar Select Yes from the Alignment dialog box to save the new alignment data to the database F1 Prev Align allows the operator to overwrite this alignment data with the previous alignment data OR Select No to restore the previous alignment data Utilities Page 10 62 IMMAGE 800 Operations Manual A11403 March 2004 Alignment Wash Head Automatic Depth Alignment Wash Head Automatic Depth Alignment Follow the steps below to perform the automatic depth alignment Step Action 1 Select Utilities from the menu bar 2 Select lt 4 gt Alignment OR Enter 4 in the Option No field and press Enter 3 Use the Page Up and Page Down buttons to view additional Utilities options Select 4 Cuvette Wash from the Functional Areas dialog box OR
52. Attempt to FATAL CALL BECKMAN COULTER Recover an CLINICAL SUPPORT Expired Cuvette 2212 Dilution Handler FATAL CALL BECKMAN COULTER Fatal Error CLINICAL SUPPORT 2214 Image Handler FATAL CALL BECKMAN COULTER Fatal Error CLINICAL SUPPORT 2215 Memory FATAL CALL BECKMAN COULTER Allocation Error CLINICAL SUPPORT for Image Stack 2216 Scheduler FATAL CALL BECKMAN COULTER Supervisor Fatal CLINICAL SUPPORT Error 2217 No Dilution WARNING 1 From Status menu check status of Wells Available dilution segments and replace segments showing zero 0 status 2 Rerun sample 2219 TDB Fatal Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 222 Failed to WARNING 1 Verify all constituents reagents Schedule Test samples buffers diluents and segments are available 2 Rerun sample 16 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 38 March 2004 Table 10 7 Displayed or Printed Error Messages continued Errors Error Table Error Abbreviation Explanation Action Message 2222 Task Fatal Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2223 Error with WARNING Will STOP CALL BECKMAN COULTER Scheduler Queue Run CLINICAL SUPPORT 2224 Illegal Queue WARNING Will STOP CALL BECKMAN COULTER Message Run CLINICAL SUPPORT Received 2225 Error in Cycle FATAL CALL BECKMAN COULTER Count CLINICAL SUPPORT Conversion 2402 Reaction WARNING
53. COULTER False Trigger on CLINICAL SUPPORT Reagent B at Position 814 Level Sense WARNING CALL BECKMAN COULTER False Trigger at CLINICAL SUPPORT Diluent Bottle 815 Level Sense WARNING CALL BECKMAN COULTER False Trigger at CLINICAL SUPPORT Dilution Well 816 Level Sense WARNING CALL BECKMAN COULTER False Trigger at CLINICAL SUPPORT Sample Rack 900 Software FATAL CALL BECKMAN COULTER Initialization CLINICAL SUPPORT Error 901 Error FATAL CALL BECKMAN COULTER Downloading CLINICAL SUPPORT DAS 9 of 21 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 31 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 1010 Unexpected FATAL CALL BECKMAN COULTER XCOM Error CLINICAL SUPPORT Detected 1020 XCOM Error FATAL CALL BECKMAN COULTER during Socket CLINICAL SUPPORT Create 1021 XCOM Error FATAL CALL BECKMAN COULTER during Connect CLINICAL SUPPORT 1022 XCOM Error FATAL CALL BECKMAN COULTER during CLINICAL SUPPORT Setsockopt 1023 XCOM Error FATAL CALL BECKMAN COULTER during Ioctl CLINICAL SUPPORT 1024 XCOM Error FATAL CALL BECKMAN COULTER during Bind CLINICAL SUPPORT 1025 XCOM Error FATAL CALL BECKMAN COULTER during Listen CLINICAL SUPPORT 1026 XCOM Error FATAL CALL BECKMAN COULTER during Select CLINICAL SUPPORT 1027 XCOM Error FATAL CALL BECKMAN COULT
54. Chemistry earlier in this chapter Deleting a UDR Definition The Delete function deletes a UDR definition only if the chemistry has been removed from the chemistry menu When the UDR definition is deleted the UDR reference intervals and all associated non archived patient results are deleted Refer to CHAPTER 10 Utilities Backup Restore The instrument status must be in Standby in order to proceed with the steps below to delete a UDR definition Step Action 1 From the Setup screen select lt 18 gt User Defined Chemistries 2 Choose a number beside the chemistry to be deleted 3 Select Delete F2 Refer to Figure 5 36 4 Select lt OK gt to delete the chemistry OR Select lt Cancel gt to return to the User Defined Chemistries screen without deleting the chemistry 5 Remove the reagent cartridge from the reagent carousel Delete User Def ined Chemistr Backup results prior to deleting a User Def ined chemistry Deleting a User Defined chemistry deletes all associated patient results Delete chemistry Cancel E014047S EPS Figure 5 36 Delete User Defined Chemistry Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 85 Editing UDR Definitions Introduction Editing UDR Definitions Introduction A previously defined UDR definition may be recalled and edited Editing the sample dilution and or AGXS Limit of a defined UDR clears the calibrat
55. Defined WARNING Load buffers for all defined buffer but Not Detected positions 2005 Diluent Detected WARNING Define diluent positions for all loaded but Not Defined diluents 2006 Diluent Defined WARNING Load diluents for all defined diluent but Not Detected positions 2007 Invalid Card FATAL CALL BECKMAN COULTER Type Received CLINICAL SUPPORT from MPC 2008 Reagent Handler WARNING Will STOP CALL BECKMAN COULTER Invalid Run CLINICAL SUPPORT Parameters 220 Illegal Protocol FATAL CALL BECKMAN COULTER Tree Address CLINICAL SUPPORT 2202 Scheduler Fatal FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 2204 Corrupt Cycle FATAL CALL BECKMAN COULTER Stack CLINICAL SUPPORT 15 of 21 IMMAGE 800 Operations Manual A11403 March 2004 Utilities Page 10 37 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 2205 Cycle Stack FATAL CALL BECKMAN COULTER Empty CLINICAL SUPPORT 2206 Cycle Stack Full FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2207 Frame Stack Full FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2208 Frame Stack FATAL CALL BECKMAN COULTER Empty CLINICAL SUPPORT 2209 Cuvette Handler FATAL CALL BECKMAN COULTER Fatal Error CLINICAL SUPPORT 2210 Attempt to FATAL CALL BECKMAN COULTER Enable a CLINICAL SUPPORT Disabled Cuvette 2211
56. Defining a chemistry for a position Fixed code length oooooooooooo 2 51 Beckman CheMS ooococcococo 5 4 Intercharacter gap 0 eee eee eee 2 51 Chemistry configuration o oo oo o oo 5 4 Start and stop codes 0000 eeu 2 51 Chemistry configuration screen 5 4 Code Bicis atra ple nee ACR ee 2 50 Defining CAP information Bar code parameter 20 00 5 14 Attention person field 5 27 Check digit oooooococooroooo 5 14 IDnumberfield o ooooooooooo o 5 27 Code length one 0 0 cece eee ee 5 14 Defining new panels Code length tWo eee eee ee 5 14 Panel namefield ooooooooooo 5 9 Define code length ooo 5 14 Panels lo loe EP Sb ERREUR 5 9 Fixed code length 0 eee eee 5 14 Panels screen 2 00 eee ee 5 10 Large intercharacter gap 5 14 Panels summary 5 9 Start amp stop codes matcCh 5 14 Panels summary screen llle usu 5 10 Code 39 Defining new sample comment Checkdigit eio p need End 2 50 Sample comments 0 0000 eee eee 5 60 Define code length o ooo 2 50 Sample comments screen lusus 5 60 Fixed code length 0 e eee eee 2 50 Defining print names Intercharacter gap 0 0 eee ee eee 2 50 Define print names dialog box 5 7 Gomipact disk
57. Deleting and Printing a Control Definition Follow the steps below to review delete or print a control definition Step Action 1 From the Quality Control screen select the button beside the Control Name to be reviewed 2 Select Review Control F1 Refer to Figure 9 5 3 The information about the control is displayed Select to Control ID F2 View the Control IDs defined for the Control name Select OK to return to the Review Controls screen Delete Control F3 Clear the control Select OK to delete the control OR Select Cancel to return to the Review Controls screen Print Control F10 Print a comprehensive control listing A comprehensive control listing includes the control name control lot number sample type chemistry name units assigned mean performance range QC file number and constituent code 4 Select any icon from the menu bar to exit the Review Controls screen Quality Control IMMAGE 800 Operations Manual A11403 Page 9 16 March 2004 Reviewing a Control Definition Reviewing Deleting and Printing a Control Definition Standby Host Off March 26 E014033S EPS Figure 9 5 Review Controls Screen IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 17 Deleting a Control Definition Introduction Deleting a Control Definition Introduction A previously defined control may be deleted from any o
58. E014054S EPS Figure 5 45 UDR Cancel Cal Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 101 Calibrating a UDR Chemistry Clearing a UDR Cal Rack Clearing a UDR Cal Rack The instrument status must be in Standby in order to proceed with the steps below to clear a UDR Cal rack NOTICE Do not clear a UDR Cal rack until the final curve fit model for the calibration has been selected Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select Clear UDR Cal Rack F8 Refer to Figure 5 46 2 Enter the racks to clear in the Rack s field 3 Select lt OK gt to clear the rack OR Select lt Cancel gt to exit without clearing NOTICE Clearing the User Defined Calibration Rack will clear the rack positions The calibration results for this rack will be deleted After clearing the rack the calibration results cannot be displayed with the current model with a different model or be printed Clear UDR Calibration Racks Clearing the User Defined Calibration Rack will clear the rack positions The calibration results for this rack will be deleted After clearing the rack the calibration results cannot be displayed with the current model with a different model or be printed OK Cancel E014055S EPS Figure 5 46 Clear UDR Calibration Racks Dialog Box System Setup IMMAGE 800 Operations Manual A11403 Page 5 102 March
59. EUER TU SN VR rue SEEN V ke Pus 5 103 Prat bidder e 5 113 Setting Up UDR Reference Intervals and Panels eese 5 115 Defining UDR Quality Control 1 t tuere ia ies 5 116 Programms a UDR Sample aii 5 117 Instr ment Sep E H 5 118 A ccc b o puede M e SUE A LI de mee A 5 118 Placme Labels on Rica 5 119 Wash Solution Box and Waste Container Placement sese 5 121 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 1 Overview Introduction System Software Configuration Overview Introduction In System Setup several features of the IMMAGE 800 Immunochemistry System interface can be customized for the individual laboratory s requirements Setup maintains the default parameters used for configuring the IMMAGE 800 interface These configurations can be changed when the system status is in Standby This chapter explains how to configure the chemistry menu set up panels set up bar codes set up reference intervals set up reports set up special calculations set up units non standard dilutions configure antigen excess testing set up date and time set up host communications set up replicates statistics set up sample comments set up demographics set up the printer set up the language read the chemistry protocol diskette enter the instrument serial number set up user defined reagent chem
60. F1 Demog F2 Bondy Program Sample F1 Save Next F10 Sample Options F3 Link Sample Set Variable OK Cancel Program Batch F4 7 Select Racks F1 End Batch F10 Select Control F5 Sample Options F3 Select Control F5 Clear Chem F7 Cancel Edit F9 Save Next F10 Rerun Samples F6 Edit Samples Rerun Samples Rerun Chems Cancel Clear Samples F7 Post Run Summary F8 Load List F9 Save Next F10 E011369L EPS Figure 2 20 IMMAGE 800 Program Tree 1 of 5 System Description IMMAGE 800 Operations Manual A11403 Page 2 40 March 2004 Program Structure Introduction Results Display Results F1 Update Sample F2 Send to Host F6 Report Format F7 Print Report F8 Prev Sample F9 Next Sample F10 Cancel Send F4 Send to Host F8 Report Format F9 Print Report F10 Rgts Cal 4 Read Reagent F1 Reagents Calibration Reagent Summary F2 Buffer Diluent F3 Request Cal F4 Request Calibration Clear Racks F1 Save F9 Cancel F10 Cal Options F5 Calibration Options Calibrator Summary Slope Offset Adjustment Print Last Calibration Results Cal LdList F6 Calibration Loadlist Cancel Request F7 Read Cards F8 E011370L EPS Figure 2 21 IMMAGE 800 Program Tree 2 of 5 IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 41 Program Structure Introduction QC Review Control F1 Quality Control
61. F1 then Send to to the host computer Host F6 Select Prev Sample F9 or Next Sample F10 to display other samples if more than one sample was recalled Select Send to Host F6 for each sample displayed to send it to the host computer 3 Select Cancel Send F4 to stop sending results to the host Additional Information Refer to CHAPTER 5 System Setup Host Communications Setup for information about autosend IMMAGE 800 Operations Manual A11403 Results Recall March 2004 Page 8 13 CHAPTER 9 Quality Control Table of Contents Quality Ponit 9 2 OC 9 2 OC Statistics and Rules 4 iic reo RR RATER R EN d 9 3 Defining aC onto ii quc octo ponat quio uit das alba ced Dad tas 9 6 Inte A aod e a erts tdt ds 9 12 Reviewing a Control Definition tiet ina rate eee three es etae eade rad ehe et Ra ee du tUa eR deo 9 16 Deleting a Control Defrtloli 225 os A dates quos eae DEP VO uc Fax duds 9 18 Displaying the OC Fil List ET tad 9 20 e Gg ce DP 9 22 Displavina QC SU ALIS tral 9 27 OG Chart Cevey Jennings dd AS 9 29 QC Backup Tioira oa 9 31 Restoring and Reviewing Backup Data essere rennen enne enne enne 9 34 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 1 Overview Introduction Quality Control Overview Introduction The Quality Control QC program summarizes quality control results generated on
62. However the UDR buffer and diluent are given a specific name on the sample or reagent carousel The positions and lot numbers of UDR buffer and diluent must be entered into the computer Up to 4 bottles of UDR buffers may be placed on the inner section of the reagent carousel Up to 4 bottles of UDR sample diluents may be placed on the inner section of the sample carousel Checking UDR Buffer Diluent Status The instrument status must be in Standby in order to proceed with the steps below to check the buffer and diluent status before a run Step Action 1 Select Reagents Cal from the menu bar 2 Select Buffer Diluent F3 Refer to Figure 5 38 3 Check the Remaining for a sufficient amount to complete a run The designation for a UDR buffer is BUF1 4 and BUF 10 15 BUF 1 4 is designated for system buffer BUF 10 15 is designated for user defined buffer The designation for a UDR diluent is DIL1 4 and DIL 10 15 DIL 1 4 is designated for system diluent DIL 10 15 is designated for user defined diluent Buffer Diluent Status rouse Type A 1510304 evz Ml 1604223 A tenes 4 sure A oun Sample Carousel Pos Lot ype d u se4ezox 2 DILL M L684823X 3 DILi8 A X6123456 AE xd OK Cancel E014048S EPS Figure 5 38 Buffer Diluent Status Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 91 Loading Clearing UDR Buffer and Diluent Lo
63. Immunochemistry System are shown on the following pages The reports are in the order listed in Table C 1 and Figure C 1 through Figure C 25 Table C 1 Generated Reports Report Type Report Name Results Patient Chartable Report Control Report Laboratory Report Laboratory Report with Dilutions Calibration Calibration Load List Calibration Report Sample Programming Sample Load List Post Run Summary Setup Units Slope and Offset Summary Reference Interval and Critical Range Summary User Defined Reagent User Defined Chemistry Definition Report Chemistries User Defined Calibration Results Report User Defined Calibration Report User Defined Single Point Calibration Result User Defined Single Point Calibration Update Report Plot Robust Means Data Report Quality Control QC File List by Control Name QC File List by QC File Number QC File List by Chemistry Name QC Log Report QC Log by Reagent Lot Report QC Chart Report QC Summary Report Inter Lab Summary Report Utilities Event Error Log IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 1 Introduction Patient Chartable Report Patient Chartable Report IMMAGE S N PPI1 9 07 23 1996 15 24 31 PAGE 1 BECKMAN INSTRUMENTS INC 200 S KRAEMER BLVD BREA CALIFORNIA 92622 8000 NAME SMITH JOHN SAMPLE ID 13245 PATIENT ID SAMPLE TYPE Serum
64. Introduction When connecting a laboratory information system LIS to the IMMAGE 800 several parameters must be set Refer to Restoring Defaults in this section for default settings These parameters should be set by the person configuring the connection between the IMMAGE 800 and the LIS Further information about all of the host communications parameters is found in the IMMAGE Immunochemistry Systems Host Interface Specifications Entering Sender ID The Sender ID is a free text field sent with each message header record to the host if the Message Header Mode is set to Full Header The instrument status must be in Standby in order to proceed with the steps below to enter the Sender ID Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Type the sender ID in the Sender ID field Up to 80 alphanumeric characters 66 27 1996 69 18 Status Auto Send Results Continuous El Numbering Mode Error Display Mode Operational None Mode al Request Info Multiple Hode E al oder eer Wworeviated Header _ Mode Abbreviated Header A Enter a Sender ID E010227S EPS Figure 5 21 Host Communications Parameters Screen System Setup Page 5 50 IMMAGE 800 Operations Manual A11403 March 2004 Setting Computer Port Parameters The communications port parameters must be set to match those of the LIS The instrument status must be in Standby in o
65. Manual A11403 March 2004 Sample Programming Page 7 91 Language Conversions Romaji Text Language Conversions Romaji Text Kanji Text When the sound of the Japanese word is entered in Romaji the operator can choose the display mode of Hiragana or Katakana When a phonetic character is entered in Romaji a conversion process automatically replaces the entry with a Hiragana or Katakana character For example ma is a phonetic sound entered in Romaji Conversion to Hiragana or Katakana characters occurs immediately following the keystrokes m and a Refer to the end of this section for the Hiragana and Katakana conversions The sound of the Kanji word is entered in Romaji by the operator As the sound of the Kanji word is entered in Romaji each phonetic entry in Romaji is converted to the equivalent Hiragana sequences for the Kanji word The Hiragana sequence converted from Romaji will be highlighted with a blue background for translation to Kanji characters The SPACE BAR is used to display the Kanji candidates The first time the SPACE BAR is pressed the Hiragana sequence for the Kanji word is replaced with the first Kanji character s choice from a candidate list The second time the SPACE BAR is pressed the Kanji candidate list is displayed and the first Kanji character s that was previously displayed is replaced with the second Kanji character s choice from the candidate list Each subsequent time th
66. March 2004 Page 8 9 Recalling Results by Run Date Time Additional Information Table 8 1 Run Date Time Field Entry Options Field Entries Notes Date mm 1 12 If only a From date is entered the results From and To dd 1 31 will be recalled for the 24 hour period of yy 0 99 that date The order and the separator character are defined in Setup An entry in the From field is required Time hh 1 12 A time entry is optional If only a date is From and To mm 0 59 entered results will be recalled for each 12 hour 24 hour period in the date range format AM PM Time is not allowed to be entered unless Select the options date is entered button lt W gt beside gt the AM PM field The time format is defined in Setup as 12 hour or 24 hour TOENAM EM The separator character is defined in Time hh 0 23 Setup From and To mm 0 59 The 12 hour default is AM 24 hour format Additional Information Refer to CHAPTER 5 System Setup Date and Time Setup Results Recall Page 8 10 IMMAGE 800 Operations Manual A11403 March 2004 Displaying Recalled Results on the Screen Introduction Displaying Recalled Results on the Screen Introduction All recalled results may be viewed on the screen Displaying Results Follow the steps below to display results on the screen Step Action From the Recall Results screen select the results to be viewed 2 Select Display Results F1
67. Me E Od DUE 7 37 Prosramming d COBIEOL cocer its ei d eeu Pa EVER boa aah bake dud dotum inae ORTU de UTE ON sees 7 38 Programming a S DAT A lin 7 43 Selecting SdvelNext scott ON 7 44 Programming a Batch OF Samples ta 7 45 OVA EE 7 45 Entering Editing a Batch Sample Program eese eere 7 46 Identifying Batch Samples ansia dado 7 48 Loading and Starting qa RUD ui assise rdg da IM ehe E esu ae Eden itio tii AAA Hun 7 51 Loading Samples M M is 7 51 Pre r n Checklist o eee A E tatu dtt A A 7 54 A UE PRIOR QUARTI I ME stolen Mus E a nolis e canti 7 55 Ig PE Mug ERE 7 56 O Mr 7 56 System PAUSE P HO 7 57 Pausing to Load Samples 5 soo os tse duc desea Dat gu asi REO eke du qua du e a 7 58 Rer tnimeg 3 Sample secs culata mds ida 7 61 OVAL Wound a Tui A A a AA etu tes A hs 7 61 Selecting Samples to be Rerun ica 7 62 IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 1 Editing Sample Programs Before Rerunning eese eene tenen 7 65 Rerunning Original Sample Programs A nana eased 7 67 Rerunning Selected Chemistries tocco o EPI RUE MOI NO GN M IR ta aep dates ados qu 7 68 Rerunning Controls M 7 69 Requesting a Load List or Post run Summary essere nennen nennen nennen 7 70 VEIVIOW
68. OR Select Cancel to return to the Program Sample screen without rerunning E010268S EPS Figure 7 21 Rerun Chem Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 68 March 2004 Rerunning Controls 7 Introduction Rerunning Controls Introduction Bar coded and non bar coded controls can be rerun These controls are defined in the QC program Rerunning Original Control Programs Follow the steps below to rerun original control programs Step Action 1 Choose one of the following types of control samples If the control sample then has been run and is not bar coded all chemistries defined for the control may be rerun Go to Step 2 has completed results and is all chemistries defined for the control bar coded may be rerun Go to Step 3 has incomplete results and is only the incomplete chemistries bar coded defined may be rerun Go to Step 3 2 Enter the rack and position of the previously run non bar coded control Place the sample on the sample carousel Select Run from the main menu 4 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 69 Overview Introduction Requesting a Load List or Post run Summary Overview Introduction A Load List or Post
69. On Off System Power On Introduction After the IMMAGE 800 Immunochemistry System installation the system can be powered on Power On Sequence Follow the steps below to power on the IMMAGE 800 system Step Action 1 Check that the floppy disk drive is empty Turn on the printer Turn on the monitor Turn on the CPU Nn BR Ww dy Verify that the UPS is on The UPS power switch is on and the power indicator light is on Turn on the instrument Close reagent and sample carousel covers When the note is displayed to check dilution segment status select lt OK gt Oo oo QO When the temperature warning note displays select OK The system will continue to bring the reagent chamber and reaction cuvettes to the appropriate temperature range The system will not allow a run to start until the reaction cuvettes are within the appropriate temperature range 10 Refer to CHAPTER 11 System Status Instrument Commands Checking Dilution Segment Status and Clearing Dilution Segments and CHAPTER 7 Sample Programming Checking Status and Clearing Replacing Dilution Segments 11 Refer to the appropriate chapters in this manual to operate the system System Power On Off IMMAGE 800 Operations Manual A11403 Page 4 2 March 2004 System Power On Additional Information Additional Information Refer to CHAPTER 1 General Information Precautions and Hazards f
70. Operations Manual A11403 System Status Instrument Commands March 2004 Page 11 1 Checking Dilution Segment Status and Clearing Dilution Segments Introduction System Status Instrument Commands Checking Dilution Segment Status and Clearing Dilution Segments Introduction Prior to starting every run the Dilution Segments status should be checked Options There are two options from the Dilution Segments dialog box The status of the dilution segments can be left unchanged Upto four dilution segments can be cleared The cleared segments must be replaced with unused segments on the sample carousel Checking Status and Clearing Segments The instrument status must be in Standby in order to proceed with the steps below to check the status of the dilution segments Step Action 1 Select Status from the menu bar 2 Select lt 1 gt Dilution Segments Refer to Figure 11 1 3 If dilution segments are Then to be cleared Type the segment number s in the Clear Segment s field Numbers can be separated by a comma as a series or by a dash as a range OR Select the number beside each appropriate segment AND Select OK not to be cleared Select Cancel System Status Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11 2 March 2004 Checking Dilution Segment Status and Clearing Dilution Segments After Clearing Segments Dilution Segments Clear Segment s Ava
71. Page 5 74 March 2004 Defining a UDR Chemistry Description of Definition Fields Defining a UDR Chemistry Description of Definition Fields The following table describes the fields of the Define Edit User Defined Chemistry screen Page 1 Refer to Figure 5 32 Use the tab key to navigate Table 5 7 Protocol Definition Fields Page 1 alphanumeric characters Field Entries Allowed Function Chem Name Two to five alphanumeric Unique name for chemistry characters Reagent Lot Number A maximum of eight Identifies reagent lot number alphanumeric characters Cartridge Lot Number A maximum of eight Identifies cartridge lot number alphanumeric characters Cartridge Serial A maximum of four Identifies unique serial number Number alphanumeric characters of UDR cartridge AGXS Limit 1 9999 Identifies Antigen Excess limit rate Comments A maximum of 20 Provides additional vendor information or other comments Units Conversion Factor Protocol Selection from list Not applicable Selection from list Non Competitive nephelometric Competitive nephelometric Non Competitive NIPIA Competitive NIPIA Concentration Units of UDR results Displays the conversion factor input from the Units option button e mmunoprecipitin reaction detected by rate nephelometry nhibition immunoprecipitin reaction detected by rate nephelometry e mmunoprecipitin reaction detected
72. Page 5 78 IMMAGE 800 Operations Manual A11403 March 2004 Defining a UDR Chemistry Recommended Order for UDR AGXS Flagging Limit Use Recommended Order for UDR AGXS Flagging Limit Use Step Action 1 2 Define UDR parameters Perform UDR multi point calibration 3 Approve UDR multi point calibration Note If calibration verification is desired run the calibration verification BEFORE changing the sample dilution Change UDR sample dilution optional Perform UDR AGXS Limit determination testing using UDR Rate Mode Enter UDR AGXS Limit rate value and select check the AGXS Enable box to begin UDR AGXS flagging The AGXS Enable box is located in the Define Edit User Defined Chemistry screen Refer to Figure 5 32 Run UDR samples and perform single point UDR calibration updates Additional Information Refer to CHAPTER 3 Theory of Operations Principles of Methodologies for theory of operation information Beginning a New UDR Protocol Definition The instrument status must be in Standby to proceed with the steps below Refer to the Define Edit User Defined Chemistry screen shown in Figure 5 32 Step Action 1 From Page 1 of the Define Edit User Defined Chemistry screen enter the UDR chemistry name in the Chem Name field This field is limited to 2 5 alphanumeric characters The chemistry name must not be in use for any other chemistry or calcu
73. Pans 2 hdhefi E a De ee ES 2 5 Host up unidirectional 7 84 Fatal erors vue css ELA LR er ale Rs 4 5 Host communications parameters screen 5 50 File number 200 eee eee eee ee eee 9 6 Host programming of a control 7 39 Floppy diskette 0 00 eee eee eee 2 24 Host query 0 0 eee eee 2 45 7 80 7 81 Floppy diskette drive ooo oooooo 2 22 Hydro pneumatics lees 2 14 Fl id spills s n REDDERE PES 10 8 10 9 Formatting the date 2 dldlisc er iiss soc wc iA SEIS e Bats 5 44 l 4 digits eye err Pesan eee e 5 44 Date and time screen 0 00 5 45 CONS 3 ii RD Rd E 2 28 2 31 Date time nra aaoi n eee eere 5 44 IMMAGE 800 Immunochemistry System 2 2 Day format hala feted 5 44 IMMAGE 800 Instrument 000 2 3 Day Month Year 0000s ee eee 5 44 Immunoglobulin A IGA llle sees 3 8 Leading zero 01 00 cece eee eee 5 44 Immunoglobulin G serum IGG urine IGU 3 8 Month Day Year 5 44 Immunoglobulin M IGM lessen 3 8 Month format eene 5 44 Industry standards 0 0 eee 2 52 No leading zero 1 0 0 2 0 eee eee eee 5 44 Inhibition of immunoprecipitin by hapten drug 3 6 Order M EMT 5 44 Inserting a blank position for chemistry insertion 5 5 Separator field ooooooooooooo 5 45 Insoluble complexes lisse eese 3 6 I
74. RGT CART N A TEST PENDING RGT CART N A TEST PENDING RGT CART N A TEST PENDING RGT CART N A TEST PENDING RGT CART N A TEST PENDING Introduction Post run Summary E014103L EPS IMMAGE 800 Operations Manual A11403 March 2004 Reports Page C 9 Introduction Units Slope and Offset Summary Units Slope and Offset Summary IMMAGE S N 1343 02 06 2004 14 35 44 PAGE 1 UNITS DILUTION SLOPE AND OFFSET SUMMARY SAMPLE OFFSET VALUE Plasma Serum Plasma Serum CSF Plasma Serum Plasma Serum CSF Plasma Serum CSF Plasma Urine Serum Plasma Serum Plasma E011432L EPS Figure C 9 Units Slope and Offset Summary Reports IMMAGE 800 Operations Manual A11403 Page C 10 March 2004 Introduction Reference Interval and Critical Range Summary Reference Interval and Critical Range Summary IMMAGE S N PPI2 15 04 21 1998 10 55 35 PAGE 1 REFERENCE INTERVAL AND CRITICAL RANGE SUMMARY Default range SAMPLE SEX UNITS CRITICAL RANGE 31D 90D 3M 6M 7M 10Y 11Y 40Y 41Y 100Y E014105L EPS Figure C 10 Reference Interval and Critical Range Summary IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 11 Introduction User Defined Chemistry Definition Report User Defined Chemistry Definition Report IMMAGE S N CHEM UDR6 Reagent Lot Reagent Cartridge Lot Reagent Cartridge S N Reagent Expiration Date Vendor Information Sample or D
75. Refer to Figure 8 2 3 Select Page Up or Page Down to view other pages of the same sample Each sample generates at least two report pages 4 Select Prev Sample F9 or Next Sample F10 to view other samples if more than one sample result was recalled aec TUO Kl Main Samples Besults Rats Cal gc Setup Utils Status STOP Re su 1 t S Sample Status Rack 3 Pos 4 Sample ID 12345 Patient ID Sample Type Serum Run Date 87718796 18 17 parrene Off Line Dilution Gollection 97 18 96 gg gg Age Chem Result Reference Interval Remark IGG AGXS 1198 mg dL 694 1618 IGA AGXS 205 mg dL 58 8 378 AGXS 91 4 mg dL 58 8 263 184 mg dL 88 0 201 37 2 mg dL 16 8 47 0 Report Print format Report Sanpie E F8 F9 E010286S EPS Figure 8 2 Results Screen IMMAGE 800 Operations Manual A11403 Results Recall Page 8 11 Printing Recalled Results Introduction Printing Recalled Results Introduction All recalled results may be printed Printing a Recalled Result Follow the steps below to print a recalled result Step Action 1 From the Recall Results screen select the results to be viewed as described previously in this chapter To print using then default report format Go to Step 5 non default report format Continue to Step 3 Select Report Format F7 A Patient Report Format dialog box is displayed with the following cho
76. Revolutions per minute Call Beckman Coulter Clinical Support if the Revolutions per minute is out of specifications 7 Select to Call Diag F1 Return to the Callable Diagnostics screen Start Motor F2 Run the motor continuously Stop Motor F3 Stop the motor 2 of 2 Utilities Page 10 52 IMMAGE 800 Operations Manual A11403 March 2004 Alignment Introduction Alignment Introduction The Alignment option contains procedures for alignment for the IMMAGE 800 Alignment procedures are performed on hardware components classified into different Functional Areas The instrument status must be in Standby in order to proceed with the alignments described below Functional Area There are 11 hardware components on the IMMAGE 800 that require alignment The operator can perform alignments on the Sample and Reagent Probes and the Optics Functional Areas The alignment procedures described below will adjust the following Straightness of the Sample and Reagent Probe e Sample Crane Probe Height Depth Reagent Crane Probe Height Depth Optics Wash Head Automatic Depth Alignment NOTICE Alignment procedures for all other Functional Area require assistance from Beckman Coulter Service personnel Contact Beckman Coulter Clinical Support or a local Beckman Coulter Field Service office for assistance Prerequisite Alignment Steps Prerequisite steps are note
77. Robust Means Data Report OR Select Ctrl P on the keyboard to print the Plot Robust Means Data Curve Plot Robust Means Data Curve R o b 3800 8 u s t 2500 8 M 2000 8 a n s Rack 12 Pos 5 Replicate 2 Plot Robust Means Data Curve Time Range Starting Time 20 e Ending Time 06 B 15 Default OK Cancel lA Time mm ss Enter a starting time mm ss E011440S EPS Figure 5 57 Plot Robust Means Data Curve Time Range Window System Setup Page 5 112 IMMAGE 800 Operations Manual A11403 March 2004 Printing UDR Reports Description of UDR Reports Printing UDR Reports Description of UDR Reports The following table describes the UDR report options Refer to APPENDIX C Reports for examples of the UDR Reports Table 5 16 UDR Reports Report Description Definition Report Identifies UDR chemistry definition protocol and calibration information Calibration Results Report Identifies UDR instrument response results per replicate of each UDR calibrator for the selected chemistry Calibration Report Identifies UDR mean instrument responses per replicate of each UDR calibrator for the selected chemistry the curve fit model and associated parameters Single Point Update Calibration Results Report Identifies UDR instrument response results per replicate of single point update calibrator for the selected chemistry Single Point Update Calibration Repor
78. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 96 March 2004 Host Communication Interface 7 Hiragana Conversions From Romaji Hiragana Conversions From Romaji E b 5 A 5 A lt E a i u e o ka ki ku ke ko x L EN e tz 5 2 X E sa shi si su se so ta chi ti tsu tu te to ae da 1a D l U ES iE na ni nu ne no ha hi hu fu he ho d amp t M Wb Ux E ma mi mu me mo ya yu ye yo 5 y 5 D 3n 5A amp ra ri ru re ro wa wi we wo A nn mm Ai c i e C F Y ga gi gu ge go za di zu ze zo E 5 3 T e Ed u A iz da zi du de do ba bi bu be bo Iz U A x lz pa pi pu pe po x Zu xm Fk Ev gu Tp FE kya kyi kyu kyo gya gyi gyu gyo Le Lip La La Ue Uo Ck sha sya shu syu she sye sho syo ja ju jo 5 Bu Bip 5a 5 Be Ba 5w bx BE cha tya tyi cyi chu tyu che tye cho tyo dya di dyi dyu dye dyo cya cyu cye cyo n zt lt p Iz De Dor Ow Ux UL nya nyi nyu nyo hya hyi hyu hye hyo Us Uo Un Ua Uk US Un Up Us bya byi byu bye byo pya pyi pyu pyo 55 Ax AR Ad d PH Fp d fa fi fe fo mya myi myu myo Ue Yep Us rya ryu ryo y 5 A E D H A l U E O TSU TU tt ss kk pp tc YA YU J015152L EPS Figure 7 32 Hiragana Conversions From Romaji IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 97 Host Communication Interface Katakana Conversions From Romaji Katakana Conversions From Romaji 7 4 a i y y sa shi si F na ni Y 3 ma mi 7 Jy ra ri yv nn mm H ga gi a gt da
79. T510169 SAMPLE DILUENT DIL1 O INSTRUMENT TARGET CAL LOT RESPONSE RESPONSE UNIT mg dL mordL mqg dL 18 Jul 96 11 26 M411018 IGM CALIBRATED TO 104 00 mg dL so STAT AR CAL ID CAL 1 M503084 RACK POS REACTION BUFFER BUF1 TS10169 SAMPLE DILUENT DIL1 1510168 INSTRUMENT TARGET CHEM LOT RESPONSE RESPONSE c3 M512146 4 ca CALIBRATION FAILED INSTRUMENT ERROR E010315L EPS Figure C 6 Calibration Report IMMAGE 800 Operations Manual A11403 Reports Page C 7 March 2004 Introduction Sample Load List Sample Load List IMMAGE S N PPI1 9 Figure C 7 SAMPLE ID PATIENT NAME VPRX1 Control 12345 SAMPLE LOAD SAMPLE TYPE DILUTION Serum Serum Sample Load List LIST REPLICATES CHEMISTRIES IGA 07 18 1996 10 13 38 PAGE 1 STATUS Sampie Required E010316L EPS Reports Page C 8 IMMAGE 800 Operations Manual A11403 March 2004 Post run Summary IMMAGE S N PPI2 15 RUN DATE T 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 04 22 1998 Figure C 8 IME 12 I2 12 12 12 12 11 dps 11 11 11 11 11 11 11 11 RACK POS AARHAHDWbHADAAKHTHDD Post run Summary POST RUN SUMMARY SAMPLE ID 04 22 1998 12 45 11 PAGE 1 REMARKS ORLO E61 ORLO E63 RGT CART N A TEST PENDING ORLO E58 ORLO E58
80. Up gt lt Page Down gt buttons to access additional chemistries 5 Select lt OK gt to display the QC Chart s OR Select lt Cancel gt to cancel the Chart request 6 Select the lt Page Up gt lt Page Down gt buttons to access all requested QC charts 1 of 2 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 29 QC Chart Levey Jennings Accessing QC Chart Step Action continued 7 Select to Control Chems F1 specify other chemistries for charting QC File F2 specify other File Numbers for charting Print F10 print a copy of the QC Chart s Standby BECKMAN Main Samples Host Off EE rg s Results Agts Cal c QC Chart Start End Date Date 61 26 98 03 26 98 PRX1 Date Time 63 16 98 19 13 93 16 98 19 12 03 16 98 18 57 63 16 98 18 57 63 16 98 18 57 03 16 98 18 57 63 16 98 18 57 93 16 98 18 40 Control QC Chens Fi Figure 9 9 38D 28D 14 00 Control Lotit M612141 Control Name Type Serum 18D Mean 16 78 ES x Ix x x Ix x x 38D Filet F2 QC Chart Setup Sanple 1SD Qc 611 PAB 28D 2 of 2 March 26 1998 89 13 2 o Status Stop F12 About Const Chem Unit Code mg dL Pg 38D of Result 16 7 16 4 16 8 16 4 16 4 16 6 16 9 16 6 E014039S EPS Quality Control Page 9 30 IMM
81. Use extreme care when removing bar coded or labeled glass sample tubes from the IMMAGE 800 sample racks to avoid breakage Rotating the tube slightly while pushing from the bottom of the tube may make removal easier General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 6 March 2004 Hazards Introduction Hazards Introduction The following hazards are identified to ensure maximum safety of the user Booting Up Close reagent and sample carousel covers and keep clear of all mechanical assemblies when booting up the system Three pronged Power Plugs The three pronged power plug from all system components of the IMMAGE 800 Immunochemistry System must be connected to a three wire grounded power source Do not use an adapter to connect the power plug to a two pronged outlet If the electrical outlet will not accept the three pronged plug notify qualified maintenance personnel they will supply the required electrical ground DO NOT UNDER ANY CIRCUMSTANCES OPERATE THE SYSTEM UNTIL AN ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY CONNECTED TO GROUND Emergency Stop Turn the instrument main power switch off if the stop button on the screen is unavailable and the instrument must be stopped immediately Cranes Keep clear of both cranes while the instrument is running Covers Keep all covers and shields in place while the instrument is running Adding Samples to
82. WLM COMM Agent SCRMGR Interna Error description SM ELANG filename Sm wndutls c linenum 2063 INSTRUMENT CAU Calibration Failed for Reagent Chemistry C3 Index 2 Error Status 32 error id 18015 11 27 WLM Message 2303 was received by the WLM COMM Agent 11 27 WLM Message 2301 was received by the WLM Agent 11 27 WLM Message 2301 was received by the WLM COMM Agent 11 27 WLM Message 2301 was received by the WLM Agent 11 26 WLM Message 2303 was received by the COMM Agent 11 26 54 WLM Message 2301 was received by the Agent 11 26 44 WLM Message 2301 was received by the Agent 11 26 34 WLM Message 2301 was received by the Agent 11 25 54 WLM Message 2303 was received by the gent 11 25 54 WLM Message 2301 was received by the Agent 11 25 44 WLM Message 2301 was received by the Agent 11 25 14 WLM Message 2301 was received by the Agent 11 21 09 WLM Message 2202 was received by the Agent 11 20 31 KEY OK 11 20 28 KEY OK KEY Display KEY bPosO2 KEY Calibrator Summary KEY Cal Options KEY Reagent Load Calibration KEY ENTER KEY ENTER KEY ENTER KEY ENTER WLM Message 2202 was received by the WLM COMM Agent INSTRUMENT LPIA Optics Check LPIA Offset 20 LPIA Offset Quality 30 LPIA Range 112074 LPIA Range Quality 131 error id 5001 INSTRUMENT NIA Optics Check NIA Offset 3 NIA Offset Quality 15 NIA Range 54932 NIA Range Quality 2248 error id 5000 11 18 23 WLM I
83. Will STOP 1 Verify cover is closed Compartment Run 2 Check Status Monitor for stable Temperature Out reaction temperature in acceptable of Range Low range 2403 Reaction WARNING Will STOP 1 Verify cover is closed Compartment Run 2 Check Status Monitor for stable Temperature Out reaction temperature in acceptable of Range High range 2404 Reagent WARNING 1 Verify reagent fans are working Compartment 2 Verify cover is closed Temperature Out 3 Check Status Monitor for stable of Range Low reagent compartment temperature in acceptable range 2405 Reagent WARNING 1 Verify reagent fans are working Compartment 2 Verify cover is closed Temperature Out 3 Check Status Monitor for stable of Range High reagent compartment temperature in acceptable range 2406 Excessive WARNING 1 Verify reagent fans are working temperature 2 Verify cover is closed difference in the 3 Check Status Monitor for stable reaction chamber reagent compartment temperature in acceptable range 2408 Analog Ground WARNING Observe Status Monitor Out of Range Low 17 of 21 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 39 Errors Error Table Table 10 7 Error Displayed or Printed Error Messages continued Abbreviation Message Explanation Action 2409 Analog Ground Out of Range High WARNING Observe Status Monitor 2410 Reference Voltage Out of Range Low WARNING
84. Y Increasing scatter signal 5 Antibody Addition 3 Buffer Addition Figure 3 2 Scatter Signal versus Time for Rate Nephelometry and Rate Turbidimetry Rate Determination The system monitors scatter signal from the antigen antibody reaction at 5 second time intervals At the end of the reaction the system mathematically calculates the rate of change of the scatter signal IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 3 Signal Measurement and Reaction Dynamics Dynamic Blanking Dynamic Blanking The IMMAGE 800 automatically performs a patented dynamic blanking algorithm for selected analytes when testing at low serum dilutions The results are improved by elimination of the nonspecific light scatter produced by the polymer enhanced reaction buffer interacting with the serum Dynamics of the Immunoprecipitin Reaction The formation of light scattering complexes is dependent on the presence of antigen and antibody molecules in optimal proportions In general the reagent contains a fixed amount of antibody which binds with antigen in the sample to form light scattering complexes Refer to Figure 3 3 A011357L EPS 1 Antibody excess 5 Antibody 2 Optimal proportion 6 Soluble complexes 3 Antigen excess 7 Insoluble complexes 4 Antigen 8 Soluble complexes Figure 3 3 Antigen antibody Reaction Under Varying Concentrations Of Antigen And Antibody Theory of Operations IMMAGE 800 Operatio
85. a dash as a range 3 If then one rack number is Press Enter to access the Pos s field entered Type the position numbers desired to be cleared up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack All positions on each rack are number is entered automatically selected The Pos s field cannot be accessed 4 Select OK Select OK again to confirm the Racks and Positions or Cancel to return to the Clear Samples dialog box OR Select Cancel to return to the Program Sample screen without clearing samples IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 79 Overview Introduction Overview Introduction Routine Operation The following tables summarize routine operating procedures for various bar code and host computer capabilities Bar Code Setup and Host Communications Setup should first be appropriately defined Refer to CHAPTER 5 System Setup Operating in Host Query Mode Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using host query Step Action 1 Check and clear as necessary e sample racks Check clear and replace as necessary e dilution segments Check e reagents buffers and diluents wash so
86. and OR chemistry Select Cancel to return to the OR Define Edit Controls screen Select Cancel to delete the without deleting the chemistry results and cumulative statistics but not the chemistry Enter a maximum of 3 alphanumeric characters in the Operator ID field Press Enter Changing Units for a Defined Chemistry Follow the steps below to change the units for a chemistry defined in a control Step Action 1 Delete the chemistry from all controls Refer to Adding or Deleting Individual Chemistries in this chapter Change the units for the chemistry Refer to CHAPTER 5 System Setup Units Setup Add the chemistry back into the control definition Refer to Adding or Deleting Individual Chemistries Redefine the chemistry Refer to Entering the Minimum Control Definition or Defining More Information for a Control Quality Control Page 9 14 IMMAGE 800 Operations Manual A11403 March 2004 Editing a Control Additional Information Additional Information Refer to CHAPTER 5 System Setup Report Setup for information on setting up a report format for surveys IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 15 Reviewing a Control Definition Introduction Reviewing a Control Definition Introduction The Review Control function allows the operator to review control definitions for 100 controls Reviewing
87. and return to the Link Samples dialog box OR Select lt Cancel gt to return to the Link Samples dialog box without unlinking the samples Running Linked Samples Follow the steps below to run linked samples Step Action 1 Load the linked samples onto the instrument 2 Select Main from the menu bar AND Select Run 3 Select lt OK gt in the Check Dilution Segments dialog box to start the run OR Select lt Cancel gt to exit without starting the run Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 36 March 2004 Setting Variables 7 Introduction Setting Variables Introduction Variables are used in Custom Calculations as placeholders in formulas to represent more than one number value The numeric value of the variables can be entered on the Set Variables screen A maximum of six variable values may be entered The values apply only to the current sample Setting the Variables Follow the steps below to set the variables Step Action 1 Select the desired chemistry ies from the Program Sample screen Select Sample Options F3 Select lt Set Variables gt 2 3 4 Select an options button lt W gt from the Set Variables dialog box 3 Select the number beside the desired variable OR Enter the number of the desired variable in the Option No field OR Select Cancel to return to the Set Variables dialog box 6 Enter the v
88. bottle is pressurized and is constantly replenished with wash solution from the Wash Solution Container When the source runs out of wash solution it may be necessary to fill the internal wash bottle after replacing the empty Wash Solution Container Filling the Internal Wash Bottle Follow the steps below to fill the internal wash bottle The instrument status must be in Standby Step Action 1 Select Utilities from the menu bar 2 Select lt 8 gt Fill Internal Wash Bottle from the Utilities dialog box OR Enter 8 in the Option No field and press Enter 3 Select an icon from the menu bar to exit NOTICE The level of wash solution in the internal wash bottle can be verified through the Instrument Status Monitor Refer to CHAPTER 11 System Status Instrument Commands Checking the Instrument Status Monitor IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 67 Calibrate Touch Screen Introduction Calibrate Touch Screen Introduction The IMMAGE 800 system can access screen components with the optional touch screen monitor After calibration of the touch screen software functions can be activated by the touch of a finger or other object Any icon button or field on the screen can be selected by touching the icon button or field on the screen Calibrating the Touch Screen The instrument status must be in Standby in order to proceed with the steps below to calibrate the touch sc
89. button the button can be selected by pressing the Spacebar Page Up Page Down Buttons An exception to the use of the Tab key or arrow keys are page up page down buttons These buttons cannot be chosen The Page Up and or Page Down keys on the keyboard are equivalent to the lt Page Up gt and lt Page Down gt buttons respectively Selecting a Number from a List If there is a list of items to choose from the user may select an item by typing the number of the item in the text box and pressing Enter A range of numbers can be entered by entering the first number followed by a dash followed by the last number in the range Example 1 5 selects 1 2 3 4 and 5 A list of discontinuous numbers can be entered by separating the items with a comma Example 1 5 8 10 selects 1 5 8 9 and 10 Using the Touch Screen When the touch screen is used the screen can be touched with a finger or any other object Any button on the screen can be selected by touching the button on the screen Any text field can be chosen by touching the field on the screen IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 35 Selecting vs Choosing Introduction Selecting vs Choosing Introduction Selecting an item or field is different from choosing the item or field Text fields can only be chosen Buttons toggle buttons and check boxes can be chosen and selected Choosing Definition Using the Tab key
90. by the user 5 Sample Bar Code Scans bar codes on the sample carousel Reader including bar coded sample tubes sample rack bar codes background bar codes calibrator bar codes reagent bar code cards calibrator bar code cards 6 Sample Carousel Rotates the Sample Carousel to allow access for Advance Button loading sample racks dilution segments and sample diluent bottles 7 Background Bar Code Informs instrument of presence or absence of Label sample tube When the sample bar code reader can read the background bar code no sample tube is present at that position IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 11 Sample Crane Description Sample Crane Description The sample crane transfers samples and diluents Sample dilutions are made in the dilution wells and then delivered to the reaction wheel The Sample Crane functions in the same manner as the Reagent Crane Refer to Figure 2 7 A010496P EPS Sample Probe Mixer Sample Syringe Pump Sample Crane Wash Station Sample Addition Ports Poe c Figure 2 7 Sample Crane System Description IMMAGE 800 Operations Manual A11403 Page 2 12 March 2004 Component List Sample Crane Component List The following table lists each component of the sample crane with its function Table 2 5 Sample Crane Components Number Component Function 1 Sample Probe Aspirates sample and diluent and dispe
91. can be loaded Reagent cartridge 40 150 or 300 tests per cartridge Reaction buffers 4 bottles can be loaded Buffer bottle 120 mL 350 tests Samples 72 samples can be loaded Sample diluents 4 bottles can be loaded Diluent bottles 120 mL number of dilutions is workload dependent Sample dilution segments 4 segments of 36 wells each Dilution well 300 uL Wash solution 1 box 10 L approximately 1 000 tests Waste container 5 gallons 18 9 L IMMAGE 800 Operations Manual A11403 System Description Page 2 47 Peripheral Devices Specifications Introduction Peripheral Devices Specifications Introduction Refer to the inserts which accompany the respective peripheral devices computer printer etc for product specifications System Description IMMAGE 800 Operations Manual A11403 Page 2 48 March 2004 Sample Containers Allowed Introduction Sample Container Information Sample Containers Allowed Introduction The following categories document specifications for sample containers that can run on the IMMAGE 800 Immunochemistry System Primary Tubes 16 x 100 mm 10 mL 16 x 75 mm 7 mL 13 x 100 mm 7 mL 13 x 75 mm 16 5 x 92 mm Secondary Aliquot Tubes 16 x 100 mm 16 x 75 mm 13 x 100 mm 12 x 75 mm Microtubes 13 x 100 mm SYNCHRON Microtube Sample Cups NOTICE Low humidity and high ambient temperature may cause evapora
92. can be useful when a specific sample is known to have unusually low or high test results Sample Options System Replicates Sample Replicate Link Set Sample Variables OK Cancel E011447S EPS Figure 7 8 Non Standard Dilutions Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 31 Selecting Non Standard Dilutions Selecting a Non Standard Dilution Selecting a Non Standard Dilution Follow the steps below to select a Non Standard Dilution from the Non Standard Dilution list Step Action 1 Change the Sample Type if different from the default Sample Type Refer to Selecting a Sample Type in this chapter Select the chemistry desired Select Sample Options F3 from the Program Sample screen Select the options button lt W gt in the Non Standard Dilution column that is beside the desired chemistry Type the number of the desired dilution and press Enter OR Select the number beside the desired dilution Sample Programming Page 7 32 IMMAGE 800 Operations Manual A11403 March 2004 Entering an Off line Dilution Factor 7 Introduction Entering an Off line Dilution Factor Introduction An Off line Dilution Factor may be entered for a sample through the Sample Options screen This factor represents a user prepared dilution of the sample The Default Dilution normally used in the calculation of concentration for an analyte
93. compartment contains the electronic circuit boards Refer to Figure 2 9 Electronic circuit boards should only be handled by a Beckman Coulter service representative 1 Circuit Boards Figure 2 9 Electronics Compartment IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 15 Upper Instrument Subsystems Power Supply Assembly Power Supply Assembly All of the power supplies used by the IMMAGE 800 instrument are contained in this area of the instrument Refer to Figure 2 10 Power supply assemblies should only be handled by a Beckman Coulter service representative A010019P EPS 1 Power Tower 2 Power Switch 3 Electrical Outlet Voltage Selector Figure 2 10 Power Supply Assembly System Description IMMAGE 800 Operations Manual A11403 Page 2 16 March 2004 Wash Solution Box and Waste Container Description Wash Solution Box and Waste Container Description The wash solution box and waste container are stored separately from the IMMAGE 800 instrument Refer to Figure 2 11 A010073P EPS Wash Solution Box Wash Solution Tubing Waste Container Waste Tubing RON Figure 2 11 Wash Solution Box and Waste Container Component List The following lists the components depicted in Figure 2 11 Table 2 6 Wash Solution Box and Waste Container Components Item Component Function 1 Wash Solution Box 2 Wash Solution Tubing blue and orange Holds wash solution
94. computer and printer Refer to Figure 2 1 The system is shipped complete for installation The system will be installed by a Beckman Coulter Representative A011408P EPS 1 Instrument 2 Computer 3 Printer Figure 2 1 The IMMAGE 800 Immunochemistry System System Description IMMAGE 800 Operations Manual A11403 Page 2 2 March 2004 Instrument Description Instrument Description The IMMAGE 800 instrument is the analytical unit where the samples and reagents are loaded and where the chemical reactions take place Refer to Figure 2 2 5 1 Reagent Compartment 4 Sample Carousel 2 Reagent Crane 5 Sample Crane 3 Reaction Module 6 Upper Instrument Subsystems Figure 2 2 IMMAGE 800 Instrument IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 3 Reagent Compartment Description Reagent Compartment Description The reagent compartment is the area of the instrument where the removable reagent carousel is stored The temperature of the compartment is maintained at approximately 15 C Refer to System Specifications and Characteristics Temperature and Humidity in this chapter Reaction buffer bottles are placed in the center of the reagent compartment The bottles are maintained at room temperature Refer to Figure 2 3 A011410P EPS 1 Reagent Compartment Cover 5 Reagent Bar Code Reader 2 Reagent Carousel 6 Fans 3 Reaction Buffer Bottle 7 Temperature Sensor 4
95. computer and the IMMAGE 800 instrument Insert the Installation Diskette into the floppy diskette drive Turn the computer power on 2 3 4 5 Push the button beside the CD ROM drive insert the CD ROM label side up into the CD ROM drive and close the drawer Read the introduction screen AND Press Enter to continue When Installation is complete is displayed remove the Diskette and CD ROM from the drives Turn the computer off and then on Power on the instrument NOTICE If Esc is selected at any time during installation return to Step 1 System Power On Off Page 4 6 IMMAGE 800 Operations Manual A11403 March 2004 CHAPTER 5 System Setup Table of Contents System Software ConfiguratiOn esperes revera SUR Ioa ENSE NV A INR os OE LUPA PeR Us Tae RU TS E Pu Ue DR UV Up Pega un 5 2 cuu ICE Tb E 5 2 Configuring the Chemistry Menu iso 5 4 Panel SetuP me kar a al 5 9 MAE OS A EE tea cag E a E E t E 5 13 Reference Interval SSP csi o cadran ee nn idi iniii 5 17 ISG OEE SA A i D 3 od ote base uin Suet ns qua UA itd dedu due dut T RN eU iif uias au eR su duO 5 25 Caloulatioms Setup M 5 28 Units ni erc Ses CN CIE 5 37 Selecting Non Standard Dilutions as Default for Each Chemistry sess 5 40 Configuring Antigen Excess Testing sooo botas utate di as ieee ae 5 42 Datsand Lime Sti aa rra 5 44 Host Communications S
96. data points Description of Symbols on the QC Log The following table describes the symbols and flags displayed on the QC Log Table 9 1 QC Log Symbols and Flags Symbol Flag QC Result Interpretation Westgard Rule Violation Result and yellow Warning Result is gt x2 SD and lt 3 SD from 1 28 symbol the assigned mean Result and red Warning Result is gt 3 SD from the assigned 1 3SD symbol mean Result red Warning symbol Current result and previous result gt 2 2 28 and Accuracy flag SD on the same side of the assigned mean Result red Warning symbol Current result and previous result gt 2 R 4S and Precision flag SD on the opposite sides of the assigned mean Result flagged gt 4S D Result is included in the QC Log and QC Chart but is not used to calculate statistics Deleted QC data point was deleted The date time and operator are displayed beside the deletion ES An Action Log comment is associated with the data point Quality Control Page 9 22 IMMAGE 800 Operations Manual A11403 March 2004 QC Log Accessing QC Logs Accessing QC Logs Follow the steps below to access QC logs Step Action 1 From the Quality Control screen select the control desired Use the lt Page Up gt lt Page Down gt buttons to access additional controls 2 Select QC Log F5 Enter a Start date and an End date in the date range fields The default Start End
97. date is the current date Select lt OK gt to choose the default Use Tab to toggle between fields Select lt OK gt to continue OR Select lt Cancel gt to exit 4 The QC Log may be displayed by Chemistry or by Reagent Lot The default display is by chemistry in alphabetical order To display the QC Log by Reagent Lot select Rgt Lot F2 Refer to Figure 9 7 5 Enter the date range in the date range fields Select lt OK gt to continue Data is displayed by chemistry with reagent lot listed in descending order Use the lt Page Up gt lt Page Down gt buttons to access additional data OR Select lt Cancel gt to exit 6 To print the QC Log select Print F10 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 23 QC Log Deleting a Result March 26 1998 09 01 Status Stop F12 Control Control Name Lotit Sample Tupe 1998 Mar 26 1998 PRX2 612142 Serum Reagent Interpretation Lot Date Time Result Units Current Previous M786055 03 24 1998 10 39 158 mg dL W609076 83 24 1998 10 40 36 6 mg dL Figure 9 7 Deleting a Result E014037S EPS QC Log by Reagent Lot The instrument status must be in Standby in order to proceed with the steps below Follow the steps below to delete results from the QC Log cumulative statistics Step 1 Action From the Quality Control screen select the control desired Use the lt Page Up gt lt Page Down gt
98. define a chemistry Step Action 1 From the Setup screen select 1 Chemistry Configuration Refer to Figure 5 2 Choose the position for the chemistry Choose one e Type the Beckman Coulter chemistry acronym if known e g IGG OR Select Beckman Chems F1 to display a list of all Beckman Coulter chemistries that have a protocol on the system and select the appropriate chemistry Host Off 1 IGG 19 UHPT 28 2 IGA ii UDRZ 29 12 UDR1 3a is UC3 31 14 15 16 17 18 32 33 34 35 36 Insert Delete Chem F6 Fi F3 F4 Enter chemistry name or select a function Figure 5 2 E014043S EPS Chemistry Configuration Screen System Setup Page 5 4 IMMAGE 800 Operations Manual A11403 March 2004 Configuring the Chemistry Menu Clearing All 72 Positions Clearing All 72 Positions The instrument status must be in Standby in order to proceed with the steps below to clear all positions Step Action 1 From the Setup screen select lt 1 gt Chemistry Configuration 2 3 Select Clear All F4 Select lt OK gt to clear all of the configured chemistries OR Select lt Cancel gt to return to the Chemistry Configuration screen without clearing all of the configured chemistries Inserting a Blank Position for Chemistry Insertion This function is useful for inserting a chemistry into the menu The subsequent chemistries will be incr
99. enabled 3 To disable a bar code symbology deselect the check box beside the symbology If the check box is unchecked the symbology is disabled The default is all bar code types enabled 66 27 1996 09 05 Samples Results y Status Bar Code Setup Bar Code Types Bar Code Parameters v Code 39 Code 39 Parameters v Codabar Codabar Parameters v Interleaved 2 of 5 Interleaved Parameters vf Code 128 i Bar Code Priority Enable Disable bar code priority E010218S EPS Figure 5 6 Bar Code Setup Screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 13 Bar Code Setup Bar Code Parameters Bar Code Parameters Each bar code type has different parameters that can be set The parameters can include the following range lengths enabling check digits large intercharacter gap fixed code lengths start and stop codes match The parameters available for each bar code type are shown in Table 5 1 Defaults are in bold NOTICE The bar code parameters of the IMMAGE 800 must match the parameters of the printed bar code labels Review the bar code printer setup to confirm that the parameters of the IMMAGE 800 match those of the bar code printer Code 128 is always enabled with variable code length The parameters cannot be modified or changed The Code 128 specification is 64 characters or less The defaults for bar code parameters are
100. from list Sample comment dialog box 7 22 Sample comment list 7 22 Selecting fields to be displayed in sample programming Demographics setup ooocccoccccoo oo 5 62 Demographics setup screen 5 62 Selecting message header mode Abbreviated header ooooooooo o 5 55 Full header irine regieren eei eee eee 5 55 Message header mode 0 5 55 Message header record mode 5 55 Selecting non standard dilutions 7 31 7 32 Selecting number from list 2 35 Selecting paper size Printer setup 0 2 eee eee 5 64 Printer setup dialog box 5 64 Selecting request information mode Multiple xl ena aja 5 55 Request info mode 2 eae 5 55 Single pp RR dads eae he 5 55 Selecting units for each chemistry Category oo tn Oe ew rola rec ag 5 37 Conversion factor 0 0 0 eee eee ee eee 5 37 Conversion factor field 5 37 Default units llle 5 37 Units ee obtuse pL Rete oe 5 37 5 40 Units conversion dialog box 5 37 5 38 Units dialog box 0oooooooocoooooo 5 38 Units screen 2 0 ee eee 5 38 Sending results to the hoSt 8 13 Service information llle ee eee eens 1 5 Setting bar code parameters Bar code parameter 0 20 ee aes 5 15 Setting computer port parameters Baudtate
101. from the menu bar Select Buffer Diluent F3 Open the reagent or sample compartment cover Remove the buffer or diluent from the carousel Close the reagent or sample compartment cover Select the options button lt W gt beside the position to be cleared NED Nn BY WY WN Select lt Clear gt to clear the position OR Select lt Cancel gt to return to the Reagent Status Calibration Status screen without clearing the position Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 12 March 2004 Loading Wash Solution Introduction Loading Wash Solution Introduction The wash solution is used for rinsing the probes mixers and cuvettes on the IMMAGE 800 When to Load Load a new box of wash solution when the volume of the solution is low approximately 1000 tests 10 liter box Loading the Wash Solution The instrument status must be in Standby in order to proceed with the steps below to load the wash solution Step Action 1 Remove the screw cap with the tubings and straw attached from the wash solution container in use 2 Remove the screw cap from the new container of wash solution 3 Place the cap with the tubings and straw attached into the new wash solution and screw on the cap The blue tubing is attached to the side with a straw the orange tubing is not attached to a straw 4 Verify that the blue and orange tubings are attached to the top of the cap
102. hits Low or high voltage signals transmitted through the serial communication data line Data bits are transmitted after a Start bit and before the Parity bit and Stop bit The user can configure the number of bits to be transmitted between the Start bit and Stop bit Database A collection of data stored and organized for rapid access and retrieval Diluent Sample dilution medium for most protein and drug dilutions Diluent type A specific type of sample dilution medium such as Diluent 1 DIL 1 Dilution off line A dilution factor defined by the user by which the sample result will be multiplied Dilution segment A disposable tray of 36 dilution wells IMMAGE 800 Operations Manual A11403 Glossary March 2004 Page 3 of 6 Dilution starting Dilution starting The Beckman Coulter defined default dilution ratio from the system s predefined list for an individual chemistry Dilution well A container within a dilution segment that holds sample with its diluent Dilutions non standard A chemistry dependent list of dilutions from which the starting dilution of a chemistry may be selected The sample chemistry runs automatically based on the selected non standard dilution instead of the default dilution File number QC A unique number that must be assigned to each chemistry defined for a control Hapten A small molecule that can stimulate an immune response when conjugated with a larger carrier molecule A drug is a
103. if present 3 Place an evaporation cap on each bottle Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix E Evaporation Cap Installation Instructions 4 Open the reagent or sample compartment cover Rotate the sample carousel by pressing the advance button on the instrument 5 Place buffer and diluent bottles in their defined positions on the sample or reagent carousel according to the Buffer Diluent Status dialog box 6 Close the reagent or sample compartment cover The IMMAGE 800 retains the lot and position number The Remaining will be updated when the next run is started After Loading Buffers and Diluents Recalibration of affected reagents may be necessary when reaction buffer or diluent lots are changed Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual The system assumes that lot numbers and position numbers for buffers or diluents remain the same from run to run until changed by the operator The Remaining volume on the Buffer Diluent Status dialog box is updated during a sample run IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 11 Loading Clearing Buffers and Diluents Clearing a Buffer or Diluent Position Clearing a Buffer or Diluent Position The instrument status must be in Standby in order to proceed with the steps below to clear a buffer or diluent position Step Action 1 Select Rgts Cal
104. illustrates the conjugate antibody reaction in the presence of hapten drug D i A011359L EPS 1 Conjugate antibody complexing 4 Antibody 2 Inhibition of complexing by hapten 5 Hapten 3 Conjugate Antibody Figure 3 5 Inhibition of Immunoprecipitin by Hapten drug Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3 6 March 2004 Signal Measurement and Reaction Dynamics Drug Rate Response Curve Drug Rate Response Curve In drug assays the rate response decreases with increasing hapten drug concentration Figure 3 6 illustrates the rate response for several test samples with various hapten concentrations The magnitude of the rate response decreases from test sample A to test sample E Sample E has a very low rate response indicating a high hapten concentration in the sample A011360L EPS _ X Increasing free hapten drug concentration Y Peak rate of scatter 3 A E represent peak rate values at varying free hapten levels Specific antibody and drug conjugate remain at constant levels m Figure 3 6 Drug Rate Response Curve IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 7 Antigen Excess Testing Overview Antigen Excess Testing Overview Antigen excess AGXS testing is only necessary for some IMMAGE 800 protein reagents Immunoglobulin G serum IGG urine IGU Immunoglobulin A IGA Immunoglobulin M IGM Kappa KAP Lambda LAM Haptoglobi
105. in bold Table 5 1 Bar Code Parameters Parameter Code 39 Codabar Interleaved 2 of 5 Start amp Stop Codes Match NA Enabled or NA Disabled Check Digit Enabled or Enabled or Enabled or Disabled Disabled Disabled Large Intercharacter Gap Enabled or Enabled or NA Disabled Disabled Fixed Code Length Enabled or Enabled or NA Disabled Disabled Define Code Length Any number Any number NA 10 digits 10 digits Code Length One NA NA Any even number from 0 to 14 Code Length Two NA NA Any even number from 0 to 14 Not applicable System Setup Page 5 14 IMMAGE 800 Operations Manual A11403 March 2004 Bar Code Setup Setting Bar Code Parameters Setting Bar Code Parameters The instrument status must be in Standby in order to proceed with the steps below to set bar code parameters Step Action 1 From the Setup screen select lt 3 gt Bar Code 2 Select the appropriate Bar Code Parameter button Bar Code Parameter buttons are available for selection only for enabled bar code types Define any code lengths if necessary by typing the number in the Select options appropriate for your bar code system appropriate field If additional bar code parameters are to be set repeat Steps 2 5 Select lt OK gt to save the parameters OR Select lt Cancel gt to return to the Bar Code Setup screen without saving the parameters Bar Code Priority I
106. in the System Replicates field This field is for display only and cannot be accessed except from Setup A test replicate number can be entered for each test that is selected for a sample The test replicate number defines the number of times an individual test will be repeated 1 9 test replicates are available It applies only to the current sample NOTICE The test replicates function is available only when the Sample Replicate is set to 1 Entering Sample Replicates Follow the steps below to enter a Sample Replicate number Step Action 1 Select chemistry ies from the Program Sample screen Select Sample Options F3 2 3 Choose the Sample Replicate field 4 Type the number of replicates for the sample 1 9 Entering Test Replicates Follow the steps below to enter a test replicate number Step Action 1 Select chemistry ies from the Program Sample screen Select Sample Options F3 2 3 Choose the Reps field beside the desired chemistry 4 Type the number of replicates for the test 1 9 Additional Information Refer to CHAPTER 5 System Setup Default Setup for more information on defining System Replicates IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 29 Antigen Excess AGXS Testing Introduction Antigen Excess AGXS Testing Introduction Antigen excess AGXS testing can be enabled or disabled for a
107. is ON A010556L EPS Monitor Power Switch Printer Power Switch This symbol is located beside the printer power button A green light indicates the power to the printer is ON A010555L EPS Printer Power Switch Connection Between Computer and Mouse This symbol is located beside the connection between the computer and the mouse A010557L EPS Computer Mouse Connection Connection Between Computer and Keyboard This symbol is located beside the connection between the computer and the keyboard Esp A010558L EPS Computer Keyboard Connection Connection Between Computer and Printer This text is located next to the connection between the computer and the printer Parallel General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 10 March 2004 Symbols and Labels Connection Between Computer and Monitor Connection Between Computer and Monitor This symbol is located beside the connection between the computer and the monitor _ A010559L EPS Computer Monitor Connection High Voltage Electric Shock Risk This symbol indicates high voltage or risk of electric shock A_01374C EPS High Voltage Electric Shock Risk Read Manual This symbol cautions that the manual should be read before using the system A 01361C EPS Read Manual General Biohazard Caution This symbol is the international symbol for biohazardous material Ah A 01362C EPS Biohazard La
108. is allowed to be edited e chemistries may be added or deleted STAT check box e Sample Comment Test Replicates AGXS testing Non standard dilutions Reuse Dilution Option There is an option to reuse the dilution made in the dilution well when a sample was originally run Refer to Editing Programs Before Rerun Step 3 This option can be useful when sample volume is limited Reuse Dilution cannot be used if the necessary dilution segments were cleared or removed from the sample carousel If Reuse Dilution is selected and there is not enough diluted sample available in the dilution well the dilution will be remade in a new well Note The default is to remake a dilution A CAUTION Due to the possibility of sample evaporation over time the Reuse Dilution feature should be used with discretion Clear Chems Option There is an option to clear all of the chemistries originally selected for a sample Refer to Editing Programs Before Rerun Step 3 This option can be useful when the original sample program had several chemistries selected and only one or two chemistries are to be rerun IMMAGE 800 Operations Manual A11403 Sample Programming Page 7 65 Editing Sample Programs Before Rerunning Editing Programs Before Rerun Editing Programs Before Rerun Follow the steps below to edit individual sample programs before rerunning Step Action 1 Select Rerun Samples F6 from the Program Sampl
109. lis 04 9 mm dd amp mm dd yy E jl k Ba m 707 Fh ait p BAIDEAALT Pew hh m J010256S EPS Figure 7 27 Patient Demographic Screen 1 MI Middle Initial It is recommended that the MI field be disabled in the demographics screen setup Refer to Chapter 5 System Setup when running the IMMAGE 800 in the Japanese language mode IMMAGE 800 Operations Manual A11403 Sample Programming Page 7 89 Data Text Entry Screens and Fields Recall Results Screen Refer to Figure 7 28 Patient Last Name First Name MI aM EE AA ID BBA ME MAS J014099S EPS Figure 7 28 Recall Results Screen Setup e Sample Comments Screen Refer to Figure 7 29 J010229S EPS Figure 7 29 Sample Comments Screen 1 Ml Middle Initial It is recommended that the MI field be disabled in the demographics screen setup Refer to Chapter 5 System Setup when running the IMMAGE 800 in the Japanese language mode Sample Programming Page 7 90 IMMAGE 800 Operations Manual A11403 March 2004 Report Setup Screen Refer to Figure 7 30 Facility Name Facility Address Attention Person Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92622 8000 800 854 3633 S W 5 70 07 A BRESR E AR Z 1D BS 12345 6789 BARAZOOR sek 310 438 45 3 OED ZRA Ms Mary Jane Smith J014090S EPS Figure 7 30 Report Setup Screen Data Text Entry 7 Screens and Fields IMMAGE 800 Operations
110. mode Roman press the Shift Caps Locks keys at the same time To return to Hiragana press the Katakana Hiragana key To change from Hiragana to Katakana press the Shift Katakana Hiragana keys at the same time To return to Hiragana press the Katakana Hiragana key The one byte two byte key is used as a toggle to switch between half width and full width characters IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 87 Data Text Entry Introduction Data Text Entry Introduction Data text entry of Japanese characters are only available from the Japanese keyboard provided Japanese words are entered in Romaji for translation to Hiragana Katakana and or Kanji Screens and Fields The screens and fields available for text entry of Japanese characters are Main Sample Program Screen Refer to Figure 7 26 e Sample Comment om ose Belmar 14 EA AERE eS Figure 7 26 Sample Programming Screen Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 88 March 2004 Data Text Entry 7 Screens and Fields Demographics Screen Refer to Figure 7 27 e Sample Comment Patient Last Name First Name MI Patient Comment Physician Name e Location Collected By HAHA TAE MEE tz a o rs cal oro leer Las 13627 el Buc BABE ii 1 EN TUE ER Ad 0 tel ma I Hit tit BS a ae hel nae G E p 2 Shh ag hm _ al S amp 7 aR
111. or arrow keys moves the user to the various items on the screen by highlighting one item at a time An item is highlighted when a dark line appears around it When the item is highlighted that item is chosen but no action occurs Selecting Definition Pressing the Spacebar selects the chosen item on the screen When an item is selected the software performs the appropriate action Text fields cannot be selected only chosen Selecting Choosing by Mouse or Touch screen Buttons toggle buttons and check boxes are selected with the user s first action and the Spacebar is not needed when using the mouse or touch screen System Description IMMAGE 800 Operations Manual A11403 Page 2 36 March 2004 Dialog Boxes Definition Dialog Boxes Definition Cancel 0K Dialog boxes are smaller than the total size of the screen and generally do not include a bottom row of function keys The purpose of a dialog box is to input a single piece of data This piece of data may be as simple as confirming the user s request for the system to perform an action Refer to Figure 2 19 Data is entered into dialog boxes the same as it is entered into the working area of any screen Timed Urine Parameters Urine Volume Collection Period E010254S EPS Figure 2 19 Dialog Box Example Most dialog boxes will have a lt Cancel gt button This button closes the dialog box without entering the requested data or denies confirmat
112. package of 10 96395 Evaporation Caps IMMAGE package of 20 470707 Fan Filters Power Supply 928389 Host Interface Specifications IMMAGE Immunochemistry Systems English Refer to CD ROM Product Manuals Keyboard English 974072 French 974073 German 974074 Italian 974075 Spanish 974076 Japanese 448778 Labels Bar Code Test 450418 Sample Rack package of 1 99 447628 Maintenance Kit IMMAGE Systems 470739 Maintenance Logbook English Refer to CD ROM Product Manual 962324 Manual IMMAGE Immunochemistry Systems Chemistry Information Refer to CD ROM Chemistry Information Manual IMMAGE 800 Immunochemistry System Instructions For Use Refer to CD ROM Product Manuals Manual IMMAGE 800 Immunochemistry System Operations Refer to CD ROM Product Manuals Material Safety Data Sheet Package English 447210 French 447211 German 447212 Italian 447213 Spanish 447214 2 of 4 Part Number List IMMAGE 800 Operations Manual A11403 Page A 2 March 2004 Table A 1 Part Number List continued Description Part Number Microtube SYNCHRON package of 1000 448774 package of 100 756776 Bar Coded Label Microtube package of 500 470683 Mixer Paddle Assembly 470453 Monitor 15 inch color 470742 Mouse Pad 470733 Paper Printer 8 2 x 11 inch 963827 Printer 120 volt 963423 220 volt 965223 Printer Cartridge 966602 Probe Assembly 470688 Racks IMMAGE Sample 16 x 7
113. procedure for label placement IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 19 Racks Loading Rack onto the Sample Carousel Loading Rack onto the Sample Carousel Follow the steps below to load a rack onto the sample carousel Refer to Figure 2 13 Step Action Press the Advance button to advance the sample carousel to an empty slot Lift the rack by its handle Open the cover of the sample carousel Align rack pegs over holes in the sample carousel Mn BY wy N Lower rack pegs into carousel holes A010086P EPS Figure 2 13 Loading Rack onto the Sample Carousel System Description Page 2 20 IMMAGE 800 Operations Manual A11403 March 2004 Computer Description Computer Description The computer supplies the user interface to the IMMAGE 800 Immunochemistry System and stores data The user performs all software interaction on the computer portion of the system This software interaction is stored on the computer and is sent to the instrument at the appropriate time Additionally patient results control results and setup parameters are stored on the computer NOTICE Only the computer supplied by Beckman Coulter is to be used with the IMMAGE 800 Immunochemistry System Changing the Date on the PC The PC supplied with some IMMAGE 800 systems contains a battery that provides power to the computer s internal clock during po
114. sample E34 Buff LVL Level Sense Failure on 1 Check and remove bubbles from Buffer buffer 2 Observe that reagent probe enters buffer 3 Rerun sample E35 Dil LVL Level Sense Failure on 1 Check and remove bubbles from Diluent diluent 2 Rerun sample 3 of 21 IMMAGE 800 Operations Manual A11403 March 2004 Utilities Page 10 25 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message E36 Sample LVL Level Sense Failure on 1 Check and remove bubbles from Sample sample 2 Verify sufficient sample volume is present 3 Rerun sample E37 RGT A N A Reagent Compartment A Calibrate reagent Unavailable E38 RGT B N A Reagent Compartment B Calibrate reagent Unavailable E39 Buff N A Buffer Unavailable Load a new buffer bottle and verify that buffer position is defined correctly E40 Dil N A Diluent Unavailable Load a new diluent bottle and verify that diluent position is defined correctly E41 Hrdwr N A Hardware Unavailable Home system E42 Excess Scat Excessive Scatter CALL BECKMAN COULTER CLINICAL SUPPORT E43 Blank Term Assoc Blank Terminated CALL BECKMAN COULTER CLINICAL SUPPORT E44 S W Error Bad Test Object Address CALL BECKMAN COULTER CLINICAL SUPPORT E45 Uncal RGT Uncalibrated Reagent Recalibrate reagent E46 DilWell Err Dilution Segments n
115. should be considered in the creation of a user prepared dilution The Off Line Dilution Factor applies to the current sample only When a sample using an off line dilution factor is run the system makes no further dilutions It runs the sample as is it does not create the default dilution or any out of range dilutions Each result is automatically multiplied by the user entered off line dilution factor Example To assay an IGA sample at twice the default dilution To make twice the dilution of the analyte being assayed the user must know the Default Dilution and appropriate diluting fluid for the analyte Find the Default Dilution and diluting fluid for IGA in IMMAGE Immunochemistry Systems Chemistry Information Manual APPENDIX B Measuring Ranges Dilution Fluids The Default Dilution for IGA is 1 36 The diluting fluid for IGA is DIL 1 Prepare the Default Dilution for the analyte being tested For IGA make a 1 36 dilution by diluting 1 part serum in 35 parts of DIL 1 Prepare a 1 2 dilution of the previously prepared Default Dilution Dilute 1 part of Default Dilution in 1 part of DIL The final dilution factor is now 1 72 Enter an Off line Dilution Factor of 72 during sample programming The system will produce a final result by automatically multiplying each test result from the sample by 72 Alternatively the user may run an off line dilution without selecting to use this feature The system will per
116. station If the cuvette washer is lowered into a cuvette select lt Home gt from the Main screen to raise the cuvette washer 2 Remove the two reaction module cover screws 1 X 7 A010038PEPS Figure 10 12 3 Slide reaction module cover forward from under cuvette wash station as shown A010032P EPS Figure 10 13 1 of 3 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 17 As Indicated Maintenance Replacing Cuvettes Step Action continued 4 Unscrew cuvette cover plate counterclockwise Remove cover plate A010033P EPS Figure 10 14 5 Remove cuvettes by lifting upward Rotate the wheel as necessary to access all the cuvettes Dispose of the used cuvettes in a manner appropriate for biohazardous materials 6 Wipe the wheel with lint free tissue moistened with DI water 7 Replace all cuvettes handling by the top edges only Refer to Figure 10 15 Confirm that all cuvettes are seated in the reaction carousel Figure 10 15 Replace the covers 9 Select Utilities from the menu bar 10 Select 7 Wash Cuvettes from the Utilities dialog box OR Enter 7 in the Option No field and press Enter 11 Type the first cuvette number 1 to begin the wash in the Starting Range field and press Enter 2 of 3 Utilities Page 10 18 IMMAGE 800 Operations Manual A11403 March 2004 As Indicated Maintenance Replacing Cuvettes
117. status must be in Standby in order to proceed with the steps below to approve a UDR calibration model The Multi Point UDR Calibration Result report must show at least one instrument response IR for each calibrator level If not the entire calibration run must be repeated The exception to rerunning the entire calibration occurs when one of the calibrator levels has a status of Incomplete The incomplete sample may be rerun as part of the same calibration rack and its results added to the rest of the calibration data Step Action 1 From the User Defined Chemistries screen select Approve Cal F5 2 Use lt Page Up gt or lt Page Down gt to review the plots of the models for the calibration The last page has a composite plot of all the models To print a curve fit model plot press Ctrl P on the keyboard 4 Select Model F1 to display the curve fit model options Refer to Figure 5 53 5 Select the number beside the model desired and select lt OK gt to approve the UDR calibration OR Select lt Cancel gt to exit the User Defined Model dialog box 6 Select Print Report F8 to print the data and statistics for a curve fit model 7 Program controls on the UDR through Sample Programming to see if they are acceptable with the chosen calibration model before clearing the UDR cal rack To test another model with controls repeat Steps 1 7 8 When the final calibration model has been selecte
118. steps below to access a previously defined control and to edit an assigned mean SD constituent code or control ID of a previously defined control Step Action 1 From the Quality Control screen select the button beside the control name to be edited 2 Select Define Edit F2 Refer to Figure 9 3 1 of 2 Quality Control IMMAGE 800 Operations Manual A11403 Page 9 12 March 2004 Editing a Control Accessing a Control to Edit Step Action continued 3 Enter the new Mean value beside the chemistry it corresponds to in the Assigned Mean field Press Enter Enter the 1 SD value beside the chemistry it corresponds to in the Assigned SD field Press Enter A Define Edit Controls dialog box is displayed when there are new values entered in the Assigned Mean and or Assigned SD fields Select to 1 Restore previously defined exit the Define Edit dialog box mean SD and continue and restore the previously defined mean and or SD value and continue 2 Apply new mean SD and change the mean and or SD to the continue statistical database new values The previous results and cumulative statistics are saved 3 Delete existing data and change the mean and or SD to the start new statistical database new values The previous results and cumulative statistics are deleted This option is not available if the control is programmed for a run 4 Enter
119. the Assigned Mean Results greater than 4 SD are included in the QC Log and QC Chart but are not used to calculate statistics Flags Generated on Printed QC Reports These flags appear in the remarks column of the QC results report Greater than 2SD Greater than 3SD Two successive controls greater than 2SD Accuracy Two successive controls greater than 2SD on opposite sides of the assigned mean Precision Additional QC Precision Rules Some additional Westgard QC rules are helpful when determining whether the system is in control These are not flagged by the IMMAGE 800 QC program but can help in determining system performance Refer to Figure 9 1 4 1S Within or Across Last Four Results of One or Two Levels of Control Were More than 1 SD From the Mean on the Same Side This rule judges the result out of control if the last four results from one or two levels were more than 1 SD from the mean in the same direction Quality Control Page 9 4 IMMAGE 800 Operations Manual A11403 March 2004 QC Statistics and Rules Additional QC Precision Rules e 10X Within or Across Last Ten Results of One or Two Levels of Control Were All on the Same Side of the Mean This rule judges the result out of control if the last ten results from one or two levels were all on the same side of the mean Control IN CONTROL ACCEPT RUN YES OUT OF CONTROL REJECT RUN EVALUATE E015001L EPS Figure 9 1 QC Accept Rejec
120. the panel name E014095S EPS Figure 5 5 Panels Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 10 March 2004 Editing Panels Panel Setup Editing Panels The instrument status must be in Standby in order to proceed with the steps below to edit defined panels Step Action 1 From the Setup screen select lt 2 gt Panels A multipage list of panel summaries will be displayed Select the numbers beside the panels to be edited Select Define Edit F1 aJ AIJ N Rename the panel if desired Select or deselect the numbers beside each chemistry as desired Selecting Clear Chems F1 will deselect all of the selected chemistries Select the options button lt V gt beside Sample Type to change the sample type Select the sample type The default sample type is determined by the sample type selected in the Default Setup screen Refer to Default Setup Setting the Default Sample Type in this chapter to change the default sample type Select the AGXS check box beside the desired chemistry to enable or disable antigen excess testing 10 Select the options button lt W gt in the Non Std column beside the desired chemistry to change the dilution Select the number beside the desired dilution OR Enter the number of the desired dilution AND Press Enter To edit additional panels select Prev Panel F9 or Next Panel F10 to display the previous or next panel Rep
121. to return to the Select Control dialog box without saving the control program OR Select Save F10 to save the control program and return to the Program Sample screen OR Select Cancel Edit F9 to return to the Program Sample screen without saving the control program Sample Programming Page 7 40 IMMAGE 800 Operations Manual A11403 March 2004 Select Control Control Lotit M56661 M586862 M586863 Figure 7 10 Figure 7 11 Select Control Dialog Box Control Lot Control Name Program Control Screen IMMAGE 800 Operations Manual A11403 March 2004 E010259S EPS M506061 VIGILPRXL Cancel Save Edit E9 F18 E010260S EPS Programming a Control Programming a Non bar Coded Control Sample Programming Page 7 41 1 Programming a Control Alternative Methods of Selecting Controls Alternative Methods of Selecting Controls In addition to using Select Control F5 the following methods can be used to select a control Table 7 7 Alternative Methods of Selecting Controls Method If then 1 the Control ID is known type the Control ID in the Sample ID field of the Program Sample screen the Rack and Position of a completed control is known type the Rack and Position number in the Rack field and Pos field of the Program Sample screen Additional Information Refer to CHAPTER 9 Quality Control Defining a Control for more in
122. uIU L U mL mg dL nmol L IU mL ug dL pmol L mIU mL pg dL uIU mL mg mL ug mL ng mL pg mL Restoring Defaults The default units and standard dilutions for all of the chemistries can be restored with the following procedure The default unit for each chemistry is shown in the Units Dialog Box refer to Selecting Units for Each Chemistry above The default dilution for each chemistry is shown in the Non Standard Dilutions box Refer to selecting non standard dilutions for each chemistry The instrument status must be in Standby to proceed with the steps below to restore defaults Action 1 From the Setup screen select lt 7 gt Units Non Standard Dilutions 2 Select Restore Default F1 Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual defaults OR 3 Select OK to restore the defaults for units and standard dilutions Select Cancel to return to the Units Setup screen without restoring the IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 39 Selecting Non Standard Dilutions as Default for Each Chemistry Introduction Selecting Non Standard Dilutions as Default for Each Chemistry Introduction The instrument status must be in Standby in order to select a non standard dilution for a chemistry The system allows the user to select a non standard dilution to use as the initial dilution every time a particular assay is run Selectin
123. which are out of range display in red BECKMAN Main Samples Results Rats Cal Instrument Status Value Min Name 5 Volt E 12 Volt E 12 Volt E 24 Volt D 24 Volt E 24 Volt H 424 Volt S 24 Volt P Analog Ground 42 5 Ref Voltage Low Pressure High Pressure Vacuum Reaction Ctrl Temp Reagent Ctrl Temp Card Cage Temp Thermal Flags Select an option Figure 11 3 5 03 12 89 12 0 23 24 09 24 08 24 04 24 07 a 2 5 2 BES Do eco 4 50 19 88 13 20 20 40 20 40 20 40 20 48 20 40 0 10 2 38 5 m zu Setup ME C 4D RS 37 5 deg 16 0 deg 45 8 deg Utils Status Name Cycle Count Wash Level Waste Irap Level Vacuum Reservoir Level Reagent Cover Reaction Cover Console Version CAU Version Status Monitor Screen E010294S EPS System Status Instrument Commands Page 11 6 IMMAGE 800 Operations Manual A11403 March 2004 Accessing Instrument Commands Introduction Accessing Instrument Commands Introduction The Main icon can be used to access the instrument commands Stop Home Pause and Run The Stop command is also available from the menu bar or by selecting F12 Command Description The following table describes the function of each instrument command Table 11 3 Instrument Commands Command Function Stop Stops instrument immediately current samples being run will be incomplete and must be rerun All
124. will appear Refer to Figure 7 4 If the parameters are not entered the sample program cannot be saved Information must be entered as follows Step Action 1 Type the urine volume in milliliters 1 99999 0 and press Enter 2 Enter the total time in which the urine was collected Type the number of hours 0 99 and press Enter Type the number of minutes 0 59 and press Enter 3 Select OK to program the urine parameters OR Select Cancel to return to the Program Sample screen The Sample Type must be changed or the urine parameters must be entered to save the sample program Timed Urine Parameters Urine Volume Collection Period Figure 7 4 Timed Urine Parameters Dialog Box Additional Information Refer to CHAPTER 5 System Setup Default Setup for more information on defining a default Sample Type IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 21 Entering a Sample Comment Introduction Entering a Sample Comment Introduction A Sample Comment can be selected from a list defined in Setup or can be entered in the Sample Comment field Selecting Comment from List Follow the steps below to select a Sample Comment from the Sample Comment list Refer to Figure 7 5 Only one comment can be selected for a sample After a comment is selected it can be edited in the Sample Comment field Step Action 1 Select Samples from the me
125. 0 Operations Manual A11403 Page 7 16 March 2004 Selecting Chemistry Tests by Panel 7 After Panel Selection No s L Nane 1 IMMUNO IGG IGA IGM 2 COMPLEMENT c3 C4 OK Cancel E010253S EPS Figure 7 3 Panels Dialog Box After Panel Selection After a panel is selected the panel number will remain displayed the chemistries in that panel will be selected in the Chemistry Menu the sample type defined for the panel will be displayed any off line or non standard dilution defined for the panel will be applied NOTICE If multiple panels are selected their defined sample types non standard dilutions antigen excess and any off line dilutions must be the same Canceling a Panel A selected panel can be canceled by deselecting it in the Panels list The highlight will be removed A panel cannot be canceled after the sample program is saved and or the run is started Additional Information Refer to CHAPTER 5 System Setup Panel Setup for more information on defining panels IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 17 Selecting Chemistry Tests by Chemistry Introduction Selecting Chemistry Tests by Chemistry Introduction A chemistry test can be selected individually from the chemistry menu Chemistries are configured on the chemistry menu by the user in Setup A chemistry can be selected by typing the number of the chemistry in the Chem No s fiel
126. 004 Warranty and Service Policy Information Warranty Policy Warranty and Service Policy Information Warranty Policy The IMMAGE 800 Immunochemistry System is covered by and subject to the exceptions of the standard warranty enclosed with each system Failure to operate the system in accordance with this manual voids the warranty Service Information If any fault develops in the system call the Beckman Coulter Clinical Support Center Give full details of the difficulty Be sure to have the model and serial number located on the lower right side of the instrument near the front For USA and Canadian customers only Call your local Beckman Coulter office toll free from anywhere in the continental United States Alaska Hawaii and Canada at 800 854 3633 For customers outside the USA and Canada Call the nearest Beckman Coulter Field Service Office Responsibility During the Warranty Period The user is responsible for the routine preventive maintenance procedures described in the maintenance section of this manual Repairs arising from failure to perform these maintenance procedures at the indicated time intervals will be made at the user s expense Shipping Damage Each IMMAGE 800 System is carefully examined and checked by Beckman Coulter before it is shipped When you receive your new IMMAGE 800 System visually inspect the shipping container for any possible damage If there is damage notify the Beckman Coulter Service
127. 1 in the RF housing Refer to Figure 10 44 LI a gt A012192P EPS Figure 10 44 10 Secure the probe by reinstalling the set screw 11 Connect the tubing from the top of the probe assembly 12 Connect the level sense cable to the receptacle 5 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 77 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Step Action continued 13 Reinstall the crane assembly access cover Reinstall the level sense cable receptacle cover 14 Select any icon from the menu bar to exit Diagnostics 15 Prime the system Refer to Troubleshooting Daily Maintenance Procedures Priming in this chapter 16 Verify the straightness of the probe Refer to Troubleshooting Alignment Straightness of the Sample Probe in this chapter 6 of 6 Utilities Page 10 78 IMMAGE 800 Operations Manual A11403 March 2004 CHAPTER 11 System Status Instrument Commands Table of Contents System Status Instrument Commands cooooccconcccnonccononccnnnncnnononcnnnnnconnnnonnnnnrnnnn cnn nennen tenentes 11 2 Checking Dilution Segment Status and Clearing Dilution Segments ss 11 2 Checking Sample Carousel Stas ii 11 4 Checking the Instrument Status Monitor cited 11 6 Accessing Instrument COHITIHanS edo veces i ecb GU Ra I ENSE ode n te e alae aene pi vacdaseses 11 7 IMMAGE 800
128. 13 05 25 PAGE 1 EVENT ERROR LOG DATE TIME OCCURRED DESCRIPTION WLM Change of state from CAU Standby C mpcnim src wim wim log c 897 WLM Message 2602 was received by the WLM Agent WLM Change of state from CAU Stopped C mpcnim src wim wim log c 897 WLM Message 2602 was received by the WLM agent WLM Message 2611 was received by the WLM Agent WLM Change of state from CAU lt Stopping C mpcnim socc wlm wlm log c 897 SCRMGR Internal Error description SM ELANG filename sm wndutls c linenum 2063 INSTRUMENT CAU Calibration Failed for Reagent Chemistry IGU Index 2 Error Status 1 error id 18015 WLM Message 2602 was received by the WLM COMM Agent WLM Message 2202 was received by the WLM COMM Agent WLM Message 2303 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent WLM Message 2202 was received by the WLM COMM Agent WLM Message 2303 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM agent WLM Message 2303 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent WLM Message 2301 was received by the WLM COMM Agent KEY WLM Message 2301 was received by the WLM COMM Agent WLM Message 2301 was received by the
129. 14 07 KEY Event Log 82 19 1996 14 87 KEY System Setup 82 19 1996 14 06 KEY Utils 82 19 1996 14 06 KEY Utils 82 19 1996 14 06 KEY Utils 82 19 1996 14 06 KEY Alignment 82 19 1996 14 02 KEY OK 62 19 1996 14 82 Utils 62 19 1996 14 02 KEY Cancel 82 19 1996 14 02 Utils Copy to Disk Ea d A E E 0030020NA 1 1 1 1 i 1 1 1 1 1 1 1 1 1 1 E010274S EPS Figure 10 19 Display Events Dialog Box Copying to Disk After selecting the desired Event Log follow the steps below to copy the events to a disk Step Action 1 Select Copy to Disk F2 from the Event Log Screen 2 Select a drive option by selecting the options button W beside the Drive field OR Type the appropriate drive option and press Enter Refer to Figure 10 20 Insert disk into appropriate drive 4 Select OK to transfer information to a diskette OR Select Cancel to return to the Event Log Screen without copying the information IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 47 Event Log Specifying Date Time Copy to Diskette Note Copy to disk will copy the event files in MS DOS format Insert a diskette into Drive 8 7l Do you wish to continue E010275S EPS Figure 10 20 Copy to Diskette Dialog Box Specifying Date Time After selecting the desired event log follow the steps below to specify the desired date and time period Step Acti
130. 14 Complete 0 0 c cece 11 5 Reagent addition ports o oo oo 2 7 Host query fav lee kid eme Sik ee tes 11 5 Reagent bar code card 0 eee 6 5 Incomplete creiren yere iy 20 e cee eee eee 11 5 IMMAGE 800 Operations Manual A11403 Index March 2004 Page v of vii Not programmed ooccoccocc 11 5 RUNNING pentas ieu Bate eee et ere rk es 11 5 Waiting to run llle 11 5 Sample carousel status screen 11 4 Sample comment 7 10 7 22 7 23 7 45 7 46 7 65 Sample comment fieldS 7 25 Sample containers lille essen 2 49 Sample crane 000 c lees esee 2 12 Sample CUPS 0 0 c eee eee eee 2 49 Sample diluent 0 0 0 0 cece eee 2 11 Sample diluents 0000 cece eee eee 6 9 Sample ID cocida ated thea be 7 14 7 70 Sample ID clearing Dy oooooo ooo 7 78 A range of alphanumeric sample IDs 7 78 A range of sample lDS 7 78 All sample IDs oooooooocoronomo 7 78 Individual sample IDS 7 78 Sample options 0oooococccocoo o 7 28 7 45 Sample options dialog bOX 7 28 Sample paddle Mixer oooococcococcoo o 2 13 Sample probe oococccocccccoco 2 13 Sample processing llle 2 57 Sample programming options Bi directional llle 2 45 Host quety i esine eae or ee DIY 2 45 Unidirectional
131. 2 489 8 9 1 4 10 53 55 1 039 1 9 Print Print CAP F9 F18 E014038S EPS Figure 9 8 QC Summary Quality Control Page 9 28 IMMAGE 800 Operations Manual A11403 March 2004 QC Chart Levey Jennings Introduction QC Chart Levey Jennings Introduction QC Chart displays the results in a control file for a specified period default is current date in graphic form showing the position of data points relative to the assigned mean and standard deviation The results are listed by date and time most recent results first QC Chart is available for either the hard disk or the floppy disk NOTICE Flagging is based on assigned mean and SD at time of run and will not change if the assigned mean and or SD are modified Accessing QC Chart Follow the steps below to access QC chart Step Action 1 From the Quality Control screen select the control desired Use the lt Page Up gt lt Page Down gt buttons to access additional controls 2 Select QC Chart F7 Refer to Figure 9 9 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select lt OK gt to choose the default Use Tab to toggle between fields Select lt OK gt to continue OR Select lt Cancel gt to exit 4 All chemistries for the control are selected by default Deselect defined chemistries that should not be charted Multiple selections are allowed Select the lt Page
132. 24 Hour 2 12 Hour 2 Format the time by selecting the button beside Time Format Select either 1 Leading Zero 01 2 No Leading Zero 1 3 Format the hour by selecting the button beside lt Hour Format gt 4 Determine the appropriate time separator then e delete the current separator in the Separator field e type in the appropriate separator Restoring Default Formats To restore the date and time formats to their defaults select Restore Default F1 The format defaults are Date Display Format Defaults Order Day Format Month Format Year Format Separator Time Display Format Defaults Time Format Hour Format Separator month day year Leading Zero 01 Leading Zero 01 1996 four digit year 24 Hour Leading Zero 01 System Setup Page 5 46 IMMAGE 800 Operations Manual A11403 March 2004 Date and Time Setup Changing the Date Changing the Date The instrument status must be in Standby in order to proceed with the steps below to change a date Step Action 1 From the Setup screen select lt 9 gt Date Time Refer to Figure 5 18 2 Select Change Date F2 Refer to Figure 5 19 3 Correct the month displayed above the mm if needed delete the currently displayed month type the correct month in its place The digits for month can be entered with or without a leading zero For example 4 or 04 may by entered for April 4 Correct th
133. 27 24 Volt Power WARNING Observe Status Monitor Supply H Out of Range High 2428 24 Volt Power WARNING Observe Status Monitor Supply S Out of Range Low 2429 24 Volt Power WARNING Observe Status Monitor Supply S Out of Range High 2430 24 Volt Power WARNING Observe Status Monitor Supply P Out of Range Low 243 24 Volt Power WARNING Observe Status Monitor Supply P Out of Range High 2432 High Pressure WARNING With system running samples Out of Range 1 Check Status Monitor Low 2 Verify high pressure is in range 2433 High Pressure WARNING With system running samples Out of Range 1 Check Status Monitor High 2 Verify high pressure is in range 2434 Low Pressure WARNING With system running samples Out of Range 1 Check Status Monitor Low 2 Verify low pressure is in range 2435 Low Pressure WARNING With system running samples Out of Range 1 Check Status Monitor High 2 Verify low pressure is in range 2436 Vacuum Out of WARNING With system running samples Range Low 1 Check Status Monitor 2 Verify vacuum is in range 19 of 21 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 41 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 2438 Internal Wash WARNING CALL BECKMAN COULTER Bottle
134. 3 Sample Programming March 2004 Page 7 3 Checking and Clearing Sample Racks Introduction Checking and Clearing Sample Racks Introduction If sample racks were programmed for a previous run the racks must be cleared before they can be used again NOTICE If only bar coded samples are used racks and positions are automatically assigned it is not necessary to clear racks Checking Rack Status Follow the steps below to determine whether a rack is Available Step Action 1 Select Samples from the menu bar 2 Select Load List F9 3 Type the rack numbers s to be checked in the Rack s field up to 15 alphanumeric characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 4 Select Display If a Load List cannot be displayed for a requested rack the rack is Available Clearing Racks Follow the steps below to clear sample racks Step Action 1 Select Samples from the menu bar 2 Select Clear Samples F7 3 Choose the Rack s field 4 Type the rack numbers to be cleared Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 5 Select lt OK gt to clear the racks OR Select lt Cancel gt to return to the Program Sample screen without clearing racks 6 Select lt OK gt to confirm the racks to be cleared OR Select lt Cancel gt to return to the Clear Samples di
135. 4057S EPS Figure 5 48 Example of Second Order Polynomial Calibration System Setup IMMAGE 800 Operations Manual A11403 Page 5 104 March 2004 Approving a Calibration Curve Fit Model Descriptions 158 Concentration mg dL Print Report rs E014058S EPS Figure 5 49 Example of Third Order Polynomial Calibration Host Off I n s t r u n e n t R e s P o n s e E014059S EPS Figure 5 50 Example of Four Parameter Logistic Calibration IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 105 Approving a Calibration Curve Fit Model Descriptions UDR84 Composite Calibrations E014060S EPS Figure 5 51 Example of Composite Calibration Host Off n s t ES u m e n t R e s P o n s e 18 88 ota mg dL p ve Point UPA ate p E011423S EPS Figure 5 52 User Defined Single Point Update Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 106 March 2004 Plot Descriptions Approving a Calibration Plot Descriptions The following table describes the plots Table 5 15 Plot Descriptions Part Description X axis Calibrator setpoint concentrations and units defined by the protocol Y axis Instrument responses IR for each calibrator replicate Asterisks Each calibration data point Dotted line Calibration curve Letter U Single point update level Approving a UDR Calibration The instrument
136. 422S EPS Figure 5 44 User Defined Calibration Load List Screen Running the UDR Calibration The instrument status must be in Standby in order to proceed with the steps below to run a UDR calibration Step Action 1 Load the calibration samples in the appropriate racks 2 Select Main from the menu bar and Run 3 Select lt OK gt in the Check Dilution Segments dialog box to start the run OR Select lt Cancel gt to exit without starting the run 4 When the calibration run is finished a multi point or single point UDR Calibration Results report is printed Continue to Approving a UDR Calibration System Setup IMMAGE 800 Operations Manual A11403 Page 5 100 March 2004 Calibrating a UDR Chemistry Canceling a UDR Cal Request Canceling a UDR Cal Request The instrument status must be in Standby in order to proceed with the steps below to cancel a UDR cal request Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select Cancel Request F7 Refer to Figure 5 45 2 Select the requested chemistries to be canceled Select OK to cancel the calibration request The Cal Status of the canceled chemistries will return to the status prior to the calibration request OR Select Cancel to return to the User Defined Chemistries screen UDR Cancel Cal ests Serial No Remaining Cal Status 884852 A056 300 Requested OK Cancel
137. 5 mm package of 4 470717 16 x 100 mm package of 4 470718 13 x 75 mm package of 4 470719 13 x 100 mm package of 4 470720 Sample Cup Holder Kit 470755 Sample Cup Holder package of 10 Bar Coded Label 0 5 mL package of 20 Bar Coded Label 2 0 mL package of 20 Sampling Template IMMAGE Immunochemistry Systems English 962325 French 962326 Danish 988987 German 962327 Greek 988990 Italian 962328 Portuguese 988989 Spanish 962329 Swedish 988988 Japanese 962330 Chinese A11430 3 of 4 IMMAGE 800 Operations Manual A11403 March 2004 Part Number List Page A 3 Table A 1 Part Number List continued Description Part Number Software Analyzer Boot Diskette 470611 Chemistry Protocol Diskette 447180 Operating and Installation CD ROM and Diskette A13218 Syringes 250 uL 470464 500 uL 470465 Tool IMMAGE Optics Wash Head Alignment 470456 Magnet Safety Override 470558 Reaction Wheel Alignment 470450 Reagent Crane 470495 Sample Crane 470498 Uninterruptible Power Supply 120 volt 970342 220 volt 970343 Japan 970545 User Defined Reagent Kit 447255 Valve Solenoid 470283 Wash Solution Cap Assembly 470728 Wash Drain Tubing IMMAGE 470726 Waste Container 828573 Waste Tubing Kit 470551 Wheel Buffer bottle 470171 4 of 4 Includes Host Interface Specifications Instructions for Use Maintenance Logbook and Operations Manuals Part
138. 75P EPS Figure 10 26 3 Remove the left access cover 1 of the Crane Assembly by removing the two Phillips screws on the left side Loosen the Phillips screws on the right side 2 of the assembly Refer to Figure 10 27 A014076P EPS Figure 10 27 4 Rotate the assembly towards the appropriate compartment and raise the probe guard to expose the probes 3 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 57 Alignment Straightness of the Sample or Reagent Probe from side Step Action continued 5 Use the flex coupling to lower the probe so that the upper large diameter portion of the probe falls just inside the compartment and is centered on the tape 6 From the side of the instrument make marks 1 and 2 on the piece of tape where the sides of the probe line up Refer to Figure 10 28 A014077P EPS Figure 10 28 4 of 6 Utilities Page 10 58 IMMAGE 800 Operations Manual A11403 March 2004 Alignment Straightness of the Sample or Reagent Probe from side Step Action continued 7 Use the flex coupling 1 to raise the probe so that the tip of the probe is lined up with the piece of tape Refer to Figure 10 29 A014078P EPS Figure 10 29 If the tip of the probe is then centered 1 between the tape the probe is straight Refer to marks Figure 10 30 not centered between the tape align p
139. 8 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 Time 15 10 15 07 15 05 15 05 14 43 14 42 14 42 14 42 14 16 14 16 14 15 14 15 13 53 13 59 13 53 20 eje 20 10 d 39 29 12 28 18 58 48 36 26 16 Qc File Number Assigned Mean Assigned 1 SD Date 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 Time 15 02 15 01 15 01 15 01 14 39 14 39 14 38 14 38 14 18 14 12 14 11 14 11 13 50 13 49 18 49 20 59 DAS 40 18 o8 58 28 o7 o7 E OF 06 56 45 QC File Number Assigned Mcan Assigned Date 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 04 23 1998 Figure C 17 Time 15 04 15 03 15 03 15 03 14 41 14 40 14 40 14 40 14 14 14 14 14 14 r 1 SD 19 EG 40 20 os 39 28 18 57 47 37 027 0 000 993999 028 164 0 15 00 o29 0 000 99999 Result 71 0 75 1 74 1 74 4 70 3 Result 121 122 124 123 133 136 134 139 146 139 147 147 148 148 146 04 24 1998 09 12 14 PAGE 1 Qc LOG REPORT Beckman Coulter Inc 200 S Kraemer Bivd Brea CA 92622 8000 8005 854 3633 Start Date 04 01 1998 End Dato 04 24 1998 Constituent Code
140. AGE 800 Operations Manual A11403 March 2004 QC Backup Introduction QC Backup Introduction The QC Backup function saves the control information and QC View data on a floppy diskette for future review The archived data can be reviewed in the following functions Review Control QC File List QC Log e QC Summary QC Chart QC Print The control information consists of the inputs used to define a control Refer to Defining a Control in this chapter The QC View data consist of the result date result value QC rule flags deleted data point date action log comment deleted result operator ID and reagent lot number QC results that are archived on floppy diskettes may be deleted from the QC Result database on the hard disk The cumulative statistics are not affected by this deletion Why Perform Routine QC Backup The IMMAGE 800 database can store up to 35 000 QC results from 999 QC files Upon exceeding 999 QC Files a pop up window appears notifying the operator that the QC database is full Some QC Files must be deleted to make room for new QC Files Upon reaching 35 000 QC results a result associated with a File Number overwrites the oldest result related to the File Number If there are no results associated with the File Number the new result is not stored A message appears notifying the operator that the new result was not saved To avoid loss of QC results it is necessary to perform routine QC Backup Th
141. CE March 2004 BECKMAN COULTER IMMAGE 800 Immunochemistry System For n Vitro Diagnostic Use Operations Manual Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 Copyright 2004 Beckman Coulter Inc ud BECKMAN COULTER INC 4300 N Harbor Blvd Fullerton CA U S A 92835 TABLE OF CONTENTS SAFETY NOTICE CHAPTER 1 General Information Precautions and Hazards s sess 1 1 CHAPTER 2 System Description A 2 1 CHAPTER Theory of Operations aso 3 1 CHAPTER 4 System Power On Off sia 4 1 CHAPTERS System SUD A HO D MEE 5 1 CHAPTER 6 Reagents Calibration odios Ded teer iib bau ce ed teca itia bdetiaes 6 1 CHAPTER Sample Programming 15s re deco i 7 1 CHAPTER Results Recall aa 8 1 CHAPTERS Quality Control aot eotste ii 9 1 CHAPTER 10 Ut diia 10 1 CHAPTER 11 System Status Instrument Commands seen 11 1 APPENDIX A Part Number EISE rosier ERST conet ost des axed eos eae A Vnde I RA DR AR A 1 APPENDIX B Instrument Codes viii EO det cio IMG deus B 1 APPENDIX C Reports ries eenen orbem MORSU trente equi a recae Ear b a ees C 1 GLOSSARY INDEX IMMAGE 800 Operations Manual A11403 Table of Contents March 2004 Page 1 of 1 Introduction Safety Notice Introduction This safety notice summarizes information basic to the safe operation of the IMMAGE 800 Immunochemistry System described in this manual The international sym
142. Cancel to return to the Quality Control screen without deleting the results from the hard disk Enter a date range in the QC Date Range dialog box Select OK to delete the QC results from the hard disk OR Select Cancel to return to the Quality Control screen without deleting the QC results from the hard disk Quality Control Page 9 32 IMMAGE 800 Operations Manual A11403 March 2004 QC Backup QC Backup Option No 1 Backup to Disk 2 Revieu Disk Cancel E014040S EPS Figure 9 10 QC Backup Dialog Box IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 33 Restoring and Reviewing Backup Data Introduction Restoring and Reviewing Backup Data Introduction Archived data can be reviewed from a floppy diskette Review options available from the floppy include Review of control definition and cumulative statistics for a control file Display and printing of QC File List QC Log QC Summary and QC Chart Modifications to the control files that have been backed up are not allowed Reviewing Archived Data Step Action 1 From the Quality Control screen select the options button lt W gt beside QC Data Source field Refer to Figure 9 11 Select External Media Insert the archived diskette and select OK in the QC View External Media dialog box to continue OR Select Cancel to exit the dialog box Select OK on the B
143. Chemistries which utilize AGXS testing have antigen dispensed and their reaction monitored for an additional 20 seconds The instrument will automatically make the appropriate dilution for high or low samples to obtain the final answer Samples which exceed the instrument range will be flagged as Out of Range Hi or Out of Range Lo Note During the run the system tracks all reagent volumes and can switch to another bottle of the same lot number If there are no additional reagents of that lot number the test will be set to Pending prior to aspiration of sample or reagent Data Reduction 2 of 2 The following table describes the typical data reduction process performed by the IMMAGE 800 Table 2 12 Data Reduction Functions Stage Description 1 The reaction wheel operates on a 5 second cycle time During each cycle the cuvettes are spun in front of the optics station and 200 data points are taken These 200 points per cuvette are then calculated to a single value 2 For each spin the calculated value the time the data was taken and a calculated quality value is logged for each cuvette 3 When the reaction incubation time has expired on each cuvette the data logged for that cuvette is checked for certain mathematical bounds 4 The data is then checked for an increasing signal indicative of a reaction Passing the checks the data is then mathematically curve fitted to a non linear function T
144. Define Edit F2 Delete Control F3 QC File List F4 QC Log F5 QC Summary F6 QC Chart F7 Figure 2 22 Control ID F2 Delete Control F3 Print Control F10 Add Del Chems F1 Control ID F2 Delete Control F3 List CtlIName F1 List File F2 List SelChem F3 List AllChem F4 Print F10 QC Log F1 Reagent Lot F2 Delete Result F3 Action Log F4 Print F10 Print Inter Lab F9 Print F10 Control Chems F1 QC File F2 Print F10 IMMAGE 800 Program Tree 3 of 5 System Description Page 2 42 IMMAGE 800 Operations Manual A11403 March 2004 Program Structure Introduction Setup Chemistry 4 Beckman Chems F1 Configuration Beckman Chemistries Define PrtName F3 Define Print Name Clear All F4 Insert Chem F5 Insert Chemistry Delete Chem F6 Delete Chemistry UDR Main F9 Panels __ Define Edit F1 Clear Chem F1 Delete Panels F2 Panels Summary F2 Print All F10 Prev Panel F9 Next Panel F10 Bar Code _ _ Restore Default F1 Reference Interval Report Setup Restore Default F1 Calculations View Edit F1 Select TUrine F2 Define Calc F3 Delete Calc F4 Define Var F5 Units Non standard Dilutions Restore Default F1 Print All F10 Antigen Excess R
145. Displaying Deleting Reagent Parameters Introduction Reagent parameters may be displayed and or deleted from the Reagent Summary Displaying Reagent Parameters The instrument status must be in Standby in order to proceed with the steps below to display reagent parameters Step Action 1 Select Rgts Cal from the menu bar 2 Select Reagent Summary F2 Refer to Figure 6 3 3 Select a button beside the Chem lot to be displayed Select the lt Display gt button to view the reagent lot parameters Select lt Go To gt and type the Chem and Lot number Refer to Figure 6 4 THEN OR Select lt OK gt from the Reagent Lot Parameters dialog box when finished viewing the reagent lot parameters d l E l E z m zl E xy 5 x x M41ii85 M511179 M682181 W511283 M581195 M511204 411618 M587162 511285 Bejete Figure 6 3 3 01 1998 12 01 1996 03 81 1998 61 61 2008 61 61 2008 61 61 1998 01 01 1998 11 01 1996 11 01 1996 11 61 1996 GoTo OK Cal Status Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Cal Date E010239S EPS Reagent Summary Dialog Box IMMAGE 800 Operations Manual A11403 March 2004 Reagents Calibration Page 6 7 Displaying Deleting Reagent Parameters Deleting Reagent Parameters Reagent Lot Parameters IGG M5112804 Expirat
146. Down Delete Tab remain the same amp E i 657 bal EST EN biii ert Print s PR g 8 2 8 4 f Back i ns a Mz 3 3 af a ES BIS DINH HERRERA oobur E015150L EPS 1 One Byte Half width Two Byte Full width 4 Not Used 2 Roman Character 5 Katakana Mode Hiragana Mode 3 Not Used Figure 7 25 IMMAGE 800 Japanese Keyboard Keyboard Entry Data may be entered from the keyboard in the following writing modes Eigo Zenkaku Eigo Hankaku Hiragana Katakana Zenkaku Katakana Hankaku Kanji Translation from Romaji to Hiragana conversion The following writing modes and character widths may be selected from field to field or screen to screen English Full width or half width Full width Half width Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 86 March 2004 Computer 7 Keyboard Entry Hiragana Full width Katakana Full width or half width Note Kanji characters converted from Hiragana are full width When a change in the writing mode and or character width is selected using the keyboard the change is displayed on the screen The character width and type mode symbol are displayed in the lower right corner of the screen To switch from Japanese entry mode to English entry
147. E014070S EPS Figure 10 34 Utilities Screen with Touch Screen Option IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 69 Overview Introduction Replacing Parts User Servicing Overview Introduction This section describes the customer replaceable parts on the IMMAGE 800 e Syringe e Sample and Reagent Crane Mixer Paddle e Sample and Reagent Crane Probe The instrument status must be in Standby in order to proceed with the parts replacement described below Utilities IMMAGE 800 Operations Manual A11403 Page 10 70 March 2004 Syringe Replacing Syringes Syringe Replacing Syringes Refer to As Indicated Maintenance Replacing Syringes in this chapter IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 71 Sample and Reagent Crane Mixer Paddle Replacing Sample and Reagent Crane Mixer Paddle Sample and Reagent Crane Mixer Paddle Replacing Sample and Reagent Crane Mixer Paddle Follow the steps below to replace the Sample or Reagent Crane Mixer Paddle Step Action 1 Rotate the Crane Assembly toward the sample carousel 2 Remove the Crane Mixer Paddle 1 by gently pulling it down and out from the crane assembly Refer to Figure 10 35 A014083P EPS Figure 10 35 Install the new mixer paddle making sure that it is pushed all the way up and properly seated Verify the straightness of the mixer paddle Refer to Troubleshooting Callable Dia
148. ER during Accept CLINICAL SUPPORT 1030 Console to CAU FATAL Check cables between console and Communications instrument Failure Alive CALL BECKMAN COULTER Task CLINICAL SUPPORT 1201 Invalid Test FATAL CALL BECKMAN COULTER Image Element CLINICAL SUPPORT 1202 Error Scheduling FATAL CALL BECKMAN COULTER Next Transaction CLINICAL SUPPORT 1203 Start cycle does FATAL CALL BECKMAN COULTER not match current CLINICAL SUPPORT cycle 1204 Invalid Next Test FATAL CALL BECKMAN COULTER Status CLINICAL SUPPORT 10 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 32 March 2004 Table 10 7 Displayed or Printed Error Messages continued Errors Error Table Error Abbreviation Explanation Action Message 1205 Sequencer Cycle FATAL CALL BECKMAN COULTER Buffer CLINICAL SUPPORT Unavailable 1206 Scheduled FATAL CALL BECKMAN COULTER Cuvette 1s CLINICAL SUPPORT Already in Use 1207 Scheduled FATAL CALL BECKMAN COULTER Cuvette 1s Out of CLINICAL SUPPORT Range 1208 The Command FATAL CALL BECKMAN COULTER has Exceeded the CLINICAL SUPPORT Command Buffer size 1209 Maximum FATAL CALL BECKMAN COULTER Number of CLINICAL SUPPORT Cycles Exceeded 1210 Sub Sequence FATAL CALL BECKMAN COULTER Time Tick Not in CLINICAL SUPPORT Ascending Order 1212 DAS Buffer FATAL CALL BECKMAN COULTER Overflow Error CLINICAL SUPPORT 1213 Calculations FATAL
149. Enter 4 in the Area No field and press Enter 4 Select 3 Automatic Depth Alignment OR Enter 3 in the Procedure No field and press Enter 5 Complete steps 1 3 as described on the screen selecting lt Continue gt after performing each step OR Select lt Stop gt to exit Select lt Close gt to return to the Alignment screen or select lt Repeat gt to restart the alignment procedure 6 Select lt Yes gt from the Alignment dialog box to save the alignment data to a temporary file OR Select lt No gt to return to the Alignment screen without saving the alignment data 7 Select an icon from the menu bar Select lt Yes gt from the alignment dialog box to save the new alignment data to the database F1 Prev Align allows the system to overwrite this alignment data with the previous alignment data OR Select lt No gt to restore the previous alignment data IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 63 Backup Restore Introduction Backup Restore Introduction The Backup Restore option provides the ability to store data to a floppy disk or hard disk for use at a later time Backup saves data to the hard disk or to a diskette for safe storage Restore takes previously backed up data from the hard disk or diskette and places it back onto the system The instrument status must be in Standby in order to proceed with the steps below to back up or restore data
150. Error CLINICAL SUPPORT 105 P Semaphore FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 106 V Semaphore FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 107 Partition Return FATAL CALL BECKMAN COULTER Buffer Error CLINICAL SUPPORT 108 Partition Get FATAL CALL BECKMAN COULTER Buffer Error CLINICAL SUPPORT 109 Partition Ident FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 110 Queue Ident FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 111 Segment Get FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 112 Partition Create FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 7 of 21 IMMAGE 800 Operations Manual A11403 March 2004 Utilities Page 10 29 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 113 Partition Delete FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 114 Timer Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 115 Ident Semaphore FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 150 Operating FATAL CALL BECKMAN COULTER System Error CLINICAL SUPPORT 500 Motion Error WARNING Home system Sample Carousel or some other device not functional 501 Now Homing WARNING No action required Reagent Section 502 Now Homing WARNING No action required Sample Section 503 Reagent Section WARNING Home system is Inopera
151. GE 800 Immunochemistry System is a fully automated computer controlled bench top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs The system methodologies are rate turbidimetry and rate nephelometry The IMMAGE 800 is a high throughput random access analyzer that features bar code identification of samples and reagents to perform sample testing It automatically dilutes the samples and delivers them to the reaction cuvette along with other reaction constituents The system analyzes up to 72 samples per run with up to 24 analytes per sample General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 2 March 2004 How to Use This Manual Scope of This Manual How to Use This Manual Scope of This Manual This manual provides information on the operation of the IMMAGE 800 Diagnostic interpretation or the clinical significance of the assay results provided by the system are not discussed in this manual Typical and actual results are shown only to demonstrate the operating procedures parameters and characteristics of the system IMMAGE Chemistry Information Manual This manual should be used in conjunction with the IMMAGE Immunochemistry Systems Chemistry Information Manual which contains specific chemistry information for the full range of analytes available on the IMMAGE 800 Manual Conventions The IMMAGE 800 Immunochemistry System Operations Manual
152. IBRATED 01 29 2004 15 11 MODEL Third Order Polynomial Calibration INSTRUMENT RESPONSE LOW 7 2232e 000 INSTRUMENT RESPONSE HIGH 6 0137e 002 1 2727e 001 3 0674e 001 2 3030e 000 8 4542e 002 SCALE FACTOR 0 9496 E011444L EPS Figure C 24 User Defined Single Point Calibration Update Report IMMAGE 800 Operations Manual A11403 March 2004 Reports Page C 25 Introduction Plot Robust Means Data Report Plot Robust Means Data Report IMMAGE S N ppi210 01 28 2004 06 43 52 PAGE 2 UDR DATA CURVE Chem name Rack Position Repeat MEAN DATA E011445L EPS Figure C 25 Plot Robust Means Data Report Reports IMMAGE 800 Operations Manual A11403 Page C 26 March 2004 Alphanumeric character Glossary Alphanumeric character A Z a z 0 9 Analyte The component being measured Antibody Ab A protein made by the body to defend itself against a foreign substance antigen Antibody molecules bind noncovalently to the antigen that triggers their production Antigen Ag A foreign substance that triggers an antibody response from the body s immune system Antigen excess AGXS testing A test for unbound excess antibody remaining in solution after the primary reaction with antigen Excess antibody is detected by the further addition of antigen and measurement of reaction rate Assay A test A single concentration determination Assigned mean The mean value defined for a contro
153. ID for each sample in the batch Refer to Figure 7 12 Rack and Position numbers can be entered for samples that are not bar coded 3 Select End Batch F10 when all Sample IDs are entered 66 24 1996 10 33 Status Sample IDs Enter Sample ID E010263S EPS Figure 7 12 Program Batch Screen Bar Code Priority Enabled Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 48 March 2004 Identifying Batch Samples 7 Identifying Batch Samples Bar Code Priority Disabled Identifying Batch Samples Bar Code Priority Disabled Follow the steps below to identify which samples are to be included in a batch if Bar Code Priority is disabled in Setup Step Action 1 Select Program Batch F4 when all information to be applied to the batch is programmed 2 Type the rack numbers to be used for the batch Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 Refer to Figure 7 13 If the racks are then listed as available Press Enter and proceed to Step 3 not listed as available Type the rack numbers that need to be cleared Select Clear Racks AND Select OK to confirm the racks and repeat Step 2 for available racks OR Select Cancel to return to the Select Clear Racks dialog box without clearing the racks 3 Type the number of samples to be included in the batch This number must be less than or e
154. Introduction Programming a Sample Overview Introduction The following sample information can be programmed sample identification test selection sample description which consists of sample type sample comment patient ID and patient demographics sample options which consist of sample replicates test replicates off line dilution ratio antigen excess testing non standard dilutions and linking samples control samples STAT samples Additional Information Refer to CHAPTER 2 System Description Sample Container Information Sample Containers Allowed Sample Cups when using a sample cup Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 10 March 2004 Program Sample Screen 7 Accessing Program Sample Screen Program Sample Screen Accessing Program Sample Screen Select Samples from the menu bar to access the Program Sample screen Refer to Figure 7 2 06 27 1996 09 24 g ssEI 4 Samples El Rats Cal Setup Utils Status STOP Not Programmed STAT 1 Tu Serum Z Et L gt Comment SA foes Sample Status Patient chee gt Sample Program Select Rer Batch Sample Load Options Ba F3 C Control Her c Reports List F6 F7 F8 Enter Sample ID E010252S EPS Figure 7 2 Program Sample Screen Sample Status The status of the current sample is displayed on the right side of the title bar The following table decribes each status and which sample programming fi
155. MAGE Immunochemistry Systems Host Interface Specifications The instrument status must be in Standby in order to proceed with the steps below to select the operational mode Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the options button lt W gt beside Operational Mode to enter the Operational Mode dialog box 3 Select the number next to one of the operational modes below 1 None 2 UniDirectional 3 BiDirectional 4 BiDirectional with Host Query OR Select Cancel to exit the Operational Mode dialog box without selecting an operational mode System Setup Page 5 54 IMMAGE 800 Operations Manual A11403 March 2004 Host Communications Setup Selecting Request Information Mode Selecting Request Information Mode The request information mode determines whether the IMMAGE 800 queries for one or multiple samples at a time The optimal setting for this mode is determined by how the LIS processes the requests real time vs batch processing The instrument status must be in Standby in order to proceed with the steps below to select the request information mode Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 Select the options button lt V gt beside Request Info Mode to enter the Request Information Mode dialog box Select the number next to one of th
156. MMAGE 800 Operations Manual A11403 Index March 2004 Page iii of vii Instrument commands Home ree 1 te ut eee rated is 11 7 MGA Dar eut ebd RR tub pb eben 2 28 Pause ope ED eU Pees dI et 11 7 Message bar 00 0 cee eee eee 2 28 FUIS cras eles oh RUE AMA aoe a 11 7 Microalbumin MA 00 000 cece eee eee 3 8 SOP uet Steel ed a Oe by e e eet oe 11 7 Microtubes i aena a a eee 2 49 Instrument or UPS Power Switch ON 1 9 Minimum control definition 9 6 9 7 Instrument status monitor 11 6 Minimum information llle 9 6 Inter Eab i o epee Dee Y euh 9 27 Minimum sample program required 7 14 Interleaved 20f5 lille 2 50 Minimum volumes l l 2 55 Check digit LESS eS 2 51 Mixer paddles 10 10 10 51 10 70 Code length one 20000e ee eee 2 51 MONITOR nil Evite atada a aceon 2 22 4 2 Code length tWo cece eee eee 2 51 Monitor power switch o oooooooo 1 10 MOUSE iii scien is a Re Wd 2 22 2 36 Multipage i sss pace Sete ave ek Sea eee ee 2 39 K pag Kappa KAP 5 itae rai ba 3 8 N Keyboard ooo 2 22 2 23 Keyboard equivalents 2 34 2 39 NM os Son HM ee In E Eu 7 70 Non standard dilution 7 10 7 17 7 28 7 31 7 65 L Non standard dilutions dialog box 7 31 Label print quality llle 2 52 0 Label sources 00200 e eee eee
157. Manual A11403 March 2004 Alignment Straightness of the Sample or Reagent Probe from side Straightness of the Sample or Reagent Probe from side Follow the steps below to verify the straightness trueness of the Sample Probe viewing it from the side of the probe Step Action 1 Disable all Electro Mechanical Motion Refer to Home All and Disable All in this chapter 2 If aligning the Sample Probe If aligning the Reagent Probe follow the steps below follow the steps below Remove the sample carousel Open the Reagent Carousel lid cover by removing the two hex screws 1 on top of the carousel cover removing the two Phillips screws 2 on the right side just above the fan Refer to Figure 10 24 Place a piece of tape along the __ Place a piece of tape along the top left edge of the sample top right edge of the reagent carousel tub Refer to Figure carousel tub Refer to Figure 10 25 10 26 1 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 55 Alignment Straightness of the Sample or Reagent Probe from side Step Action continued 1 A011431P EPS Figure 10 24 ES ui Figure 10 25 2 of 6 Utilities Page 10 56 IMMAGE 800 Operations Manual A11403 March 2004 Alignment Straightness of the Sample or Reagent Probe from side Step Action continued 4 PT a A0140
158. Number List Page A 4 IMMAGE 800 Operations Manual A11403 March 2004 Introduction APPENDIX B Instrument Codes Introduction When the instrument code appears on a report the first two digits represent the chemistry and the letter s that follow represent the condition s Example the instrument code 01J means that a slope offset adjustment was applied to the chemistry IGG Chemistry Codes The codes for chemistries are shown in the following table Table B 1 Chemistry Codes Code Chemistry Code Chemistry Code Chemistry 01 IGG 16 PAB 47 THE 02 IGA 17 ALB 48 TOB 03 IGM 19 TRU 49 VPA 04 C3 20 AIM 52 DIG 05 AAT 25 APA 57 DNB 06 KAP 26 APB 58 IGE 07 TRF 27 RF 61 IGALC 08 HPT 29 AT3 62 IGMLC 09 C4 30 ASO 64 LPAX 10 AAG 32 FER 65 CRPH 11 LAM 33 IGU 12 AMG 41 CAR 13 PFB 42 GEN 14 CER 43 PHE 15 MA 44 PHY IMMAGE 800 Operations Manual A11403 Instrument Codes March 2004 Page B 1 Condition Codes Condition Codes The codes for conditions are shown in the following table Table B 2 Condition Codes Condition Code Slope offset adjustment J Calibration re enabled C Reagent expired R Simulated result S Dilution well reused W Instrument Codes Page B 2 IMMAGE 800 Operations Manual A11403 March 2004 Introduction APPENDIX C Reports Introduction Examples of reports that can be generated by the IMMAGE 800
159. P EPS Reagent Probe Mixer Reagent Syringe Pump Reagent Crane Wash Station Reagent Addition Ports Bo Figure 2 4 Reagent Crane System Description IMMAGE 800 Operations Manual A11403 Page 2 6 March 2004 Component List Reagent Crane Component List The following table lists each component of the reagent crane with its function Table 2 2 Reagent Crane Components Number Component Function 1 Reagent Probe Aspirates reagents and buffer from the reagent compartment and dispenses them into a cuvette on the reaction wheel Reagent Paddle Mixer Mixes the contents of a cuvette after reagent or buffer has been dispensed 2 Reagent Syringe Mechanism for accurate reagent and buffer Pump 500 uL aspiration and delivery through the reagent probe 3 Reagent Crane Wash Washes interior and exterior of reagent probe Station mixer 4 Reagent Addition Two openings in reaction module cover to allow Ports reagents to be added to one of two different cuvette locations IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 7 Reaction Module Description Reaction Module Description The reaction module is the area of the instrument where the reaction takes place The temperature of the reaction module is maintained at approximately 37 C Refer to Figure 2 5 and System Specifications and Characteristics Temperature and Humidity in this chapter 1 Optics 5 Cuvette Was
160. R 11 System Status Instrument Commands for more information on Dilution Segments status IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 7 Checking Reagents Buffers and Diluents Introduction Checking Reagents Buffers and Diluents Introduction Before starting a run the Reagent Status Calibration Status and Buffer Diluent Status should be checked to ensure that the appropriate chemistries buffers and diluents are on the system the volume of reagents buffers and diluents seem adequate to complete the run the chemistries are calibrated Checking Reagent Status Follow the steps below to check the status of reagents Step Action 1 Select Rgts Cal from the menu bar 2 Select Read Reagents F1 to update the status information if reagent cartridges were loaded or removed since the last run Determine if the chemistries on the carousel and the number of tests remaining are appropriate for the run Note any chemistries that require calibration Refer to CHAPTER 6 Reagents Calibration for further information on loading reagent cartridges and calibration Checking Buffer Diluent Status Follow the steps below to check the status of buffers and diluents Step Action 1 Select Rgts Cal from the menu bar 2 3 Select Buffer Diluent F3 Determine if the buffer and diluent types and the volume Remaining are appropriate for
161. Representative before his her arrival at your facility to install your system If no damage is found to the shipping container the Beckman Service Representative will supervise the unpacking of your system If it is damaged in any way the customer should file a claim with the carrier If no damage is found a visual and operational check of your system will be performed IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 5 Precautions Introduction Precautions Introduction The operational precautions below enable the user to avoid those actions which could result in an invalid quantitative determination Proper Handling of Diskettes The 3 5 inch floppy diskettes require special handling to prevent damage Do not store or place a diskette near electrical motors power supplies or generators Do not store or place a diskette near magnets or a magnetic field Proper Handling of Compact Disks Compact disks CD ROMs require special handling to prevent damage Do not place a CD ROM in direct sunlight or excessive heat or humidity Hold a CD ROM by the edges Replace a CD ROM in its case after use Sample Volumes Sample containers must contain an adequate volume of test specimen to ensure accurate aspiration Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual and the Sampling Template for information regarding volume requirements A CAUTION
162. Requested Calibration Follow the steps below to cancel a requested calibration Step Action 1 Select Rgts Cal from the menu bar 2 Select the button s to the left of the requested chemistries to be canceled 3 Select Cancel Request F7 The Cal Status of the canceled chemistries will return to the status prior to calibration request IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 29 Loading Calibrators on the Sample Carousel Introduction Loading Calibrators on the Sample Carousel Introduction When calibration is requested calibrators are placed on the sample carousel Placing Bar Coded Calibrators on the Carousel Calibration status must be Requested in order to proceed with the steps below to place bar coded calibrators on the sample carousel prior to automatic assignment Step Action 1 Locate the calibrator bar code label provided with the calibrator 2 Place the appropriate label on an empty test tube Refer to CHAPTER 2 System Description Sample Container Information for various test tube and sample cup sizes and instructions for applying bar code labels Note The labeled test tube should be saved for re use Place the tube into a sample rack Place the appropriate sample cup in the labeled test tube Place the appropriate calibrator in the sample cup Alaj AJ O Repeat steps 1 5 for any additional calibrators Continue placin
163. S c eatin 7 70 Requesting Eod List escono das 7 71 Reguestins A Post run S UTNE ys co A aes ivit m Ret Ro 7 16 JI AR LIN SANS cin ee CI c dE es eae 7 77 VMTN OW rs oc eee A cael ce are care ee A p fU d 7 77 Clearing a Sample by Sample ID vu tics 7 78 Clearing a Sample by Rack and Position 0 0 ceesecesncecssececesceceeececesceeceeececeneecseeeecseeeesaes 7 79 Routine Operation s ES 7 80 Overview E M 7 80 Host Communication SOEUR oues eee ee n dea toii viet A aAa du e i eus 7 84 Operating IMMAGE 800 in J apatiese D EE 7 85 Di cad AMAN NT URN ERIS 7 85 COMP a 7 86 Ib rss eit Ya ER TTE UM 7 88 Laungudbe CON VEIS Sao IR 7 92 Display sa SUAS ias 7 94 Host Communication Interact das tar eg 7 96 Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 2 March 2004 Overview Introduction Overview 7 Introduction Preparing for Programming Running Before programming samples and or starting a run all racks to be used must have a status of Available If the status of a rack is not Available the rack must be cleared before it can be used for programming samples the dilution segments status should be checked Segments can be cleared or left unchanged reagents reaction buffers and sample diluents should be checked wash solution volume should be checked IMMAGE 800 Operations Manual A1140
164. Sample screen 2 To enter type individual Sample IDs the Sample IDs for rerun in the Sample ID s field up to 43 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric the individual Sample IDs to be rerun in Sample IDs the Sample IDs field separated by a comma all Sample IDs 0 in the Range field Press Enter Type zzzzzzzzzzzzzzz in the Thru field 3 Select a button from the bottom of the dialog box IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 63 Selecting Samples to be Rerun Rerunning by Rack and Position Rerunning by Rack and Position Follow the steps below to enter Rack s and Position s for rerun Step 1 Action Select Rerun Samples F6 from the Program Sample screen 2 Type the rack number s desired for rerun in the Rack s field up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 If then one rack number is Press Enter to access the Pos s field entered Type the position numbers desired for rerun up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range No
165. Select OK to accept chemistries OR Cancel to return to the Define Edit Controls screen without accepting the chemistries 10 The system automatically assigns a QC File number in the QC File Number field Press Enter to accept the Auto increment QC File number OR Enter a unique file number beside each of the chemistries being defined in the QC File Number field up to 3 numeric characters 1 of 2 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 7 Defining a Control Entering the Minimum Control Definition Step Action continued 11 Enter the Mean value beside the chemistry it corresponds to in the Assigned Mean field Press Enter NOTICE The Assigned Mean is set to 0 and the Assigned SD is set to 99999 if 0 is entered in the Assigned Mean field 12 Enter the 1 SD value beside the chemistry it corresponds to in the Assigned SD field Press Enter 13 Proceed to Defining More Information on a Control to continue adding information to the control definition OR Select any icon from the menu bar to exit the Define Edit Controls screen and save the control definition 14 A message will display upon exiting the screen if there is any missing information for the control definition Refer to Figure 9 4 Select lt OK gt to exit without saving the control OR Select Cancel to return to the Define Edit screen to add the necessa
166. Step Action 1 From the Setup screen select lt 6 gt Calculations OR Enter 6 in the Options No field Select the number s beside the Custom Calculations desired OR Enter the number s corresponding to the Custom Calculations in the Option No field Select Delete Calc F4 Select lt OK gt to delete the Custom Calculations OR Select lt Cancel gt to return to the Calculations Summary screen without deleting the Custom Calculations System Setup Page 5 36 IMMAGE 800 Operations Manual A11403 March 2004 Units Setup Introduction Units Setup Introduction Units can be selected for reporting with the results and displayed throughout the IMMAGE 800 system for each chemistry Selecting Units for Each Chemistry The instrument status must be in Standby in order to proceed with the steps below to select the desired units for a chemistry Step Action 1 From the Setup screen select lt 7 gt Units Non Standard Dilutions Refer to Figure 5 13 Select the sample type then select the options button lt W gt beside the desired chemistry Refer to Figure 5 14 The default units are displayed Select the number beside the units desired for the selected chemistry and sample type OR Select Cancel to return to the Units screen without changing the units If the units selected are in a different category than the default units a Units Conversion dial
167. The calibration is programmed from the User Defined Chemistries screen shown in Figure 5 28 The calibrators are run as routine test samples using the defined protocol A UDR calibration must be on a separate run from samples for that UDR chemistry The instrument response IR for each calibrator replicate is generated Once the calibration is approved the UDR cal status is in Calibrated and UDR chemistries can be run with other Beckman Coulter chemistries Using the UDR calibration data the system will calculate a final result in the concentration units selected in the protocol Programming a UDR Calibration The instrument status must be in Standby in order to proceed with the steps below to program a UDR calibration Step Action 1 From the User Defined Chemistries screen select Request Cal F4 The UDR chemistries on the reagent carousel will be displayed Refer to Figure 5 41 2 Select up to six UDR chemistries for calibration Select OK to continue OR Select Cancel to return to the User Defined Chemistries screen 4 From the UDR Cal Assign screen enter an available rack number in the Rack field Refer to Figure 5 42 OR Select Clear Racks F1 and enter the racks and or positions to clear Select OK to clear or Cancel to exit without clearing 5 After a rack number is entered the position numbers will automatically fill in the Pos field according to the levels defined for the chem
168. W range beside the AM PM field Time is not allowed to be Select AM or PM entered unless date is entered The time format is defined in Setup as 12 hour or 24 hour Time From hh 0 23 The separator character is and To 24 mm 0 59 defined in Setup hour format The 12 hour default is AM Requesting Load List by Status Follow the steps below to request a Load List by Sample Status Step Action 1 Select Load List F9 from the Program Sample screen 2 Select the options button lt W gt beside the Status field 3 Type the number of the desired status OR Select the number beside the desired status Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 74 March 2004 Printing a Load List Requesting a Load List 7 Printing a Load List After an option to request a Load List is entered the Load List can be printed by selecting Print The Program Sample screen will appear The Load List will not be displayed Refer to APPENDIX C Reports for an example of a printed Load List Displaying a Load List After an option to request a Load List is entered the Load List can be displayed by selecting Display The Load List screen will appear Refer to Figure 7 23 Page Up and Page Down buttons appear when a displayed Load List covers more than one screen A displayed Load List can also be printed from the Load List screen by selecting Print F10 S
169. a IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 93 Display Language Display and Output Display Language Display and Output Display output is mixed scripts of Japanese and English characters with the exception of the messages captured in the Event Log which appear in English Refer to Figure 7 31 Display Events Description f o 7 8 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 62 19 1996 92 19 1996 82 19 1996 92 19 1996 92 19 1996 92 19 1996 BR iD oO om ou won eH it 1 1 1 1 1 1 1 1 al 1 2 1 1 1 Copy to Disk print Figure 7 31 Display Events Dialog Box Time 14 09 14 69 14 09 14 09 14 08 14 08 14 08 14 07 14 07 14 06 14 06 14 06 14 66 14 62 14 62 14 02 14 02 KEY Display Events KEY KEY KEY Close Display Events KEY KEY KEY KEY KEY KEY KEY KEY KEY KEY KEY KEY KEY Event Log System Setup Utils Utils Utils Alignment DK Utils Cancel Utils E010274S EPS English characters appear where Japanese characters are not appropriate such as Reagent Name or Control Name Reagent Buffer or Diluent Lot Number Calibration ID Sample ID Patient ID Control ID Button Function Label or Abbreviation Reports and Summaries are displayable and printable in mixed scripts of Japan
170. aced on the sample carousel at one time Additional samples in a batch can be placed on a subsequent run Batches and individual samples can be programmed in the same run IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 45 Entering Editing a Batch Sample Program Introduction Entering Editing a Batch Sample Program Introduction The information to be applied to all samples in a batch is entered in the Program Sample screen This information can be edited later for individual samples within the batch Entering a Batch Program Follow the steps below to enter a sample program to be applied to a batch of samples Step Action 1 Select Samples from the menu bar 2 Select chemistries from the Program Sample screen Refer to Programming a Sample Selecting Chemistry Tests by Panel and Selecting Chemistry Tests by Chemistry in this chapter for more information Select Sample Type if the Sample Type default is to be changed for the batch Refer to Programming a Sample Selecting a Sample Type in this chapter for more information Select Sample Comment if a Sample Comment is to be entered for the batch Refer to Programming a Sample Entering a Sample Comment in this chapter for more information Select Sample Options F3 if replicate AGXS testing or dilution defaults are to be changed for the batch Refer to Programming a Sample Selecting Sample Op
171. ackup diskette into the floppy disk drive Restore View Patient Copy the View patient results into the Results from Diskette system from the backup diskette View patient results can be displayed and printed they cannot be edited or sent to the host When prompted insert the backup diskette into the floppy disk drive Restore Entire Database Copy the entire backed up database from Hard Disk into the system from the hard disk Restore View Patient Copy the View patient results into the Results from the Hard Disk system from the backup hard disk 1 of 2 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 65 Backup Restore Restore Step Action continued 4 Select OK to restore the database OR Select Cancel to exit and return to the Utilities screen 5 When Restore is complete a confirmation is displayed on the screen Refer to Figure 10 33 Select OK to exit 6 Refer to CHAPTER 8 Results Recall to display and print View patient results 2 of 2 Database version 5 76 62 dated 04 82 1998 was successfully restored OK E014082S EPS Figure 10 33 Restore Complete Confirmation Dialog Box Utilities IMMAGE 800 Operations Manual A11403 Page 10 66 March 2004 Fill Internal Wash Bottle Introduction Fill Internal Wash Bottle Introduction The IMMAGE 800 is equipped with an internal wash bottle that supplies wash solution to the system where needed The internal wash
172. ackup Restore screen to view the QC database OR Select Cancel to exit without viewing the database Select OK when the database is successfully restored 1 of 2 Quality Control Page 9 34 IMMAGE 800 Operations Manual A11403 March 2004 Restoring and Reviewing Backup Data Reviewing Archived Data Step Action continued 2 Select to Review F1 review backed up control definitions QC File List F4 display and print backed up QC file lists Refer to Displaying the QC File List in this chapter QC Log F5 display the backed up QC log Refer to Accessing QC Logs in this chapter QC Summary F6 display and print a summary of the backed up data Refer to Accessing the QC Summary in this chapter QC Chart F7 view a specific backed up control chart Refer to Accessing QC Chart in this chapter Print Control F10 print backed up control ranges 2 of 2 Option No L 1 Hard Disk 2 External Media Cancel E014041S EPS Figure 9 11 QC Source Dialog Box IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 35 CHAPTER 10 Utilities Table of Contents IBID e PE 10 2 raul M 10 2 Manten ANCE o 10 4 Recommended Tools and Sup plese aii 10 4 MACACO a ARE 10 5 Maintenance Schedule vs id dad uino ia eec e aa edu tua eacus 10 6 Auto Maintenan
173. ading a New Lot of UDR Buffer Diluent or Changing a Position Loading a New Lot of UDR Buffer Diluent or Changing a Position Follow the instructions in CHAPTER 6 Reagents Calibration Loading Clearing Buffers and Diluents Loading A New Lot Or Changing A Position Replacing the Same Lot of UDR Buffer Diluent Follow the instructions in CHAPTER 6 Reagents Calibration Loading Clearing Buffers and Diluents Replacing the Same Lot After Loading Buffers and Diluents NOTICE Recalibration of affected reagents may be necessary when buffer or diluent lot numbers are changed The system assumes that lot numbers and position numbers for buffers or diluents remain the same from run to run until changed by the user The Remaining volume on the Buffer Diluent Status dialog box is updated during a sample run Clearing a UDR Buffer Diluent Position Refer to CHAPTER 6 Reagents Calibration Loading Clearing Buffers and Diluents Clearing a Buffer or Diluent Position System Setup IMMAGE 800 Operations Manual A11403 Page 5 92 March 2004 Programming Rate Mode Introduction Programming Rate Mode Introduction After the UDR chemistry protocol is defined and the chemistry is configured Rate Mode is used to optimize UDR parameters After running the UDR chemistry a report with only instrument responses IR is automatically generated A maximum of six UDRs may be programmed at one time in rate mode Rate Mode can be run
174. agent that fails calibration will be displayed and printed on the report as Pending Refer to CHAPTER 10 Utilities Troubleshooting Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 34 March 2004 Re Enabling Calibration Introduction Re Enabling Calibration Introduction The previous successful calibration can be re enabled only when a calibration fails Re enabling Calibration The instrument status must be in Standby in order to proceed with the steps below to re enable a calibration Step Action 1 Select Rgts Cal from the menu bar 2 Select the options button W to the right of the Cal ID of the failed calibration 3 From the Re enable Previous Calibration dialog box select OK to re enable the calibration OR Cancel to return to the Reagent Status Calibration Status screen without re enabling the calibration After Calibration is Re enabled The previous calibration is re enabled for all reagent cartridges of the same lot Results generated by a re enabled calibration are flagged on the laboratory and patient chartable reports under the Instrument Code Refer to APPENDIX B Instrument Codes for instrument codes IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 35 Cal Options Introduction Cal Options Introduction Cal Options is used to access Calibrator Summary calibrator lot parameters Slope and Offset Adjustment
175. agents have been optimized so that the initial measuring range will include the majority of the expected concentration values Each reagent bar code card contains information which defines the out of range high and out of range low limits Samples above or below the initial measuring range will automatically be retested at the next appropriate dilution refer to IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix B Measuring Ranges Dilution Fluids for dilution scheme IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 11 Calibration Calibration Curve Calibration Calibration Curve The calibration curve for each lot of reagent is determined by Beckman Coulter Inc In general the calibration curve is formed from eight to twelve standards of known analyte concentrations with approximately thirty points per standard tested on multiple systems The calibration curve parameters are coded onto a lot specific reagent bar code card When a reagent bar code card is read the curve parameter information is transferred and stored by the system System Calibration System calibration is accomplished by testing a single analyte concentration which is contained in a specific calibrator To ensure a valid calibration the system requires that the rate response of two replicates obtained during calibration is reproduced within a predefined percentage The averaged rate of the two replicates is used to esta
176. ainer no higher than the top of the instrument IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 121 CHAPTER 6 Reagents Calibration Table of Contents A S T R RE R E E E E E ESA 6 2 A O rH 6 2 Reagent Status Calibration Status Screen ti 6 3 Loading Reagent Calibrator Bar Coded Parameters esee 6 5 Displaying Deleting Reagent Parameters A veo anual edes 6 7 Loading Clearing Buffers and Diluents essere nennen rennen 6 9 LO AGN Wash SOLUTION FORM D 6 13 Loading Unloading Reagent Cartridges essere enne enne 6 14 C altbraBOD A KE dau A oap qot Rt IAEA 6 17 OVOLVIOW ues Sonet sim ebd quat edd fees umen a S due S cadi Ec A 6 17 Checking Calibration Status iieis deve dn oso de dd 6 18 Calibration stored 6 21 Cartridge Specific Calibration 42 eei eina disen E EYE SUI EN AERE Dee 6 22 Requesting and Canceling Calibration 00 eccceesscsssecsencecesnceceecceceeeeecseeeceeeecseeeeneeeesaees 6 26 Loading Calibrators on the Sample Carousel eese 6 30 Start ns a CADERA ou 6 33 Calibration Results i545 isa hse rh died Or 6 34 Re Enabling Calibration cuna a ie 6 35 ALD DUONG is dimos 6 36 IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 1 Overview Introduction Reagents Overview Introduction This section explains Reagent Status Calibration Status Scr
177. al user interface 2 26 2 34 Rerun edit samples screen 7 66 Reuse dil Em 7 66 Editing samples within a batch H Patient demographic 5 7 47 Electronics compartment 0 2 15 Haptoglobin HPT 0c eee eee ee eee 3 8 Electronics control compartment 2 14 Heat block temperature sensor 2 9 Emergency stop ocoocccoocccc 4 4 High voltage electric shock risk 1 11 Entering an off line dilution factor 7 33 Host communicati0NS o ooooooooooo 5 50 Environmental conditions 2 47 Auto send results 0 20020 eee eee eee 5 52 Error messages lees 10 22 Operational mode 0 0 0c eee eee 5 54 Error table ilk tat na dee Pe we 10 22 Port parameters 0 00 e eee ee eee 5 51 Event log option s 0 e eee eee 10 45 Sender IDs eek ea 5 50 Event log options 2 0s eee 10 46 Timeout value nauau anana 5 52 Example of procedure table 1 4 Host communications messages 7 84 Bidirectional with host query 7 84 Host down ki ReIeRe cse dda Red 7 84 F Host down Query in progress 7 84 A gcn ee ee E 7 84 Failed calibration 0 0 00 a 6 34 Host up Query in progress 7 84 Fanillers ce clio Si eee e 10 12 Host up biodirectional 7 84
178. alibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated Uncalibrated GoTo OK Reagent Summary Dialog Box E010239S EPS Reagents Calibration Page 6 20 IMMAGE 800 Operations Manual A11403 March 2004 Calibration History Introduction Calibration History Introduction The Calibration History window allows the operator to review the previous four calibrations and displays the following information chemistry name reagent lot number date time Cal ID scale factor reaction buffer sample diluent Displaying Calibration History Calibration history is not available for User Defined Reagents Up to four successful calibrations will be displayed Failed calibrations will not be displayed Step Action l Select Rgts Cal icon 2 From the Reagent Status Calibration Status screen select the pull down on the Cal ID field to display the Calibration History window Refer to Figure 6 1 3 The calibrations display ascending date time order with the oldest calibration listed first 4 Select lt OK gt to return to the Reagent Status Calibration screen Re Enable Calibration If the most recent calibration failed and there was a previous successful calibration the user has the option to re enable the previous calibration Step Action 1 From the Reagent Status Calibration Status screen select Re enab
179. alibrator target values Step Action 1 Display the Calibrator Lot Display dialog box for the calibrator that is to be printed Refer to Displaying Calibrator Lot Parameters Select lt Print gt to print the calibrator lot parameters OR lt OK gt to return to the Calibrator Summary Dialog box Deleting Calibrator Parameters The instrument status must be in Standby in order to follow the steps below to delete calibrator parameters Step Action 1 Select Rgts Cal from the menu bar Select Cal Options F5 Select lt 1 gt Calibrator Summary Refer to Figure 6 13 2 3 4 Select a button beside the Cal lot to be deleted THEN Select the lt Display gt button to view the calibrator lot parameters for deletion OR Select lt Go To gt and type the Cal and Lot number of 2 IMMAGE 800 Operations Manual A11403 March 2004 Reagents Calibration Page 6 37 Cal Options Definition of Slope and Offset Step Action continued 5 Select OK from the Delete Calibrator Lot Confirmation dialog box to delete the parameters OR Cancel to return to the Calibrator Summary dialog box without deleting parameters 2 of 2 Definition of Slope and Offset Slope and offset values are entered to scale a result from the IMMAGE 800 to correlate with other systems Acceptable slope entries 0 001 9999 0 Acceptable offset entries 9999
180. alog box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 4 March 2004 Checking and Clearing Sample Racks 7 After Racks are Cleared After Racks are Cleared After sample racks are cleared the rack status becomes Available associated sample programs and results remain in the database Both can be accessed through Results Recall by any option except Rack and Position Additional Information Refer to Requesting a Load List in this chapter for more information on the Load List function Refer to Clearing a Sample in this chapter for more information on the Clear Samples function IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 5 Checking Status and Clearing Replacing Dilution Segments Introduction Checking Status and Clearing Replacing Dilution Segments Introduction Prior to starting every run the Dilution Segments status should be checked Options There are two options from the Dilution Segments status screen The status of the dilution segments can be left unchanged Upto four dilution segments can be cleared The cleared segments must be replaced with unused segments on the sample carousel Checking Status and Clearing Segments The instrument status must be in Standby in order to proceed with the steps below to check the status of the dilution segments Step Action 1 Select Status from the menu bar 2 Select l
181. alue of the variable in the Value field and press Enter Select lt OK gt to set the variable and return to the Sample Options dialog box OR Select Cancel to return to the Sample Options dialog box without setting the variable Additional Information Refer to CHAPTER 5 System Setup Calculations Setup for more information on special calculations IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 37 Programming a Control Introduction Programming a Control Introduction Control IDs Control names and lot numbers are defined in QC along with information including e Sample Type Control chemistries Upto eight unique Control IDs Mean and Standard Deviation Controls may be identified by bar code labels or by Rack and Position Control results are compared to the ranges defined by the mean and standard deviation Controls cannot be included during batch programming of patient samples Control IDs like Sample IDs must be unique for each sample within a run Control Batch F1 cannot be accessed when control definitions do not include Control IDs Sample Control IDs must be used when programming controls in batch Control IDs unlike Sample IDs can be reused after the control sample is run When the sample status of a Control ID is Complete or Incomplete the Control ID can be selected to run again the status will automatically change to Sample Require
182. ample ID Sample Type Patient Name Dilution Serum Serum Serum 2103 LEMERCIER MARIE 2116 Serum PEREZ JUAN 127 CSF SCHMIDT HANS 06 24 1996 16 53 Status Replicates Chemistries 103 1 4 1 IGG 1 IGA 1 IGHM 1C3 104 1 IGG 1164 1 IGM 1C3 1 C4 1 IGG 1 IGG Figure 7 23 Load List Screen Additional Information Status Pg Sample Required Sample Required Sample Required Sample Required Sample Required Print F18 E010265S EPS Refer to CHAPTER 5 System Setup Date and Time Setup for more information on defining date and time formats IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 75 Requesting a Post run Summary Introduction Requesting a Post run Summary Introduction The Post Run Summary feature provides a list of samples that are pending or incomplete in reverse chronological order The summary includes Run date and time Rack and position e Sample ID Chemistry name Remarks The operator has the option to choose the time frame for the Post Run Summary report The Post Run Summary Time Search includes None 12 Hour 24 Hour 48 Hour 72 Hour Accessing the Post Run Summary Follow the steps below to access the Post Run Summary Step Action 1 Select Samples from the menu bar 2 Select Post Run Summary F8 3 Select Print F10 to print the Post Run Summary OR Selec
183. ample dilution in the Sample Dilution field Entries may be from 1 5 to 1 50 OR Enter 1 1 for an undiluted sample 12 Select the options button lt W gt beside the Reaction Time field 13 Select the reaction time number from the list 14 Select the lt Page Down gt button to go to Page 2 of the Define Edit User Defined Chemistry screen 15 Continue to Defining UDR Calibration Information 3 of 3 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 83 Defining UDR Calibration Information Defining UDR Calibration Information Defining UDR Calibration Information Defining UDR Calibration Information The out of range low value for the protocol is the lowest non zero calibrator setpoint concentration The out of range high value for the protocol is the highest calibrator setpoint concentration The instrument status must be in Standby in order to proceed with the steps below to define the calibration information on Page 3 of the Define Edit User Defined Chemistry screen Refer to Figure 5 35 Step Action 1 From Page 3 of the Define Edit User Defined Chemistry screen enter the number of Cal Setpoint levels in the Levels field Entries may be from four to nine Enter the number of replicates to be run per Cal Setpoint level in the Replicates field Entries may be from one to nine Enter a Cal Level number in the Update Level field for a single point calibration updat
184. an Operating Instrument The instrument status must be in Standby when adding or changing reagents buffers diluents or dilution segments The instrument status must be in Standby or Pausing OK to load samples when adding or removing samples Keep reagent and sample carousel covers closed while the instrument is running Pausing the System to Load Samples If you pause the system to load or remove samples while the system is running DO NOT load or remove samples until the OK to load samples message appears on the screen Failure to comply may cause personal injury IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 7 Hazards Replacing Mechanical or Electrical Parts Replacing Mechanical or Electrical Parts Before replacing any defective mechanical or electrical part in the system confirm that the power to the system is turned off Bar Code Readers DO NOT tamper with or remove the housing of any bar code reader Disposal of Waste Liquids All waste liquids from the IMMAGE 800 Immunochemistry System should be disposed of in an approved method for handling biohazardous material Biological Samples Observe all laboratory policies or procedures pertaining to the handling of biological samples that may contain pathogens Preservatives Sodium azide preservative may form explosive compounds in metal drain lines See National Institute for Occupational Safety and Health bulletin Explo
185. an and SD values may be edited as data is collected for the individual laboratory Each laboratory should establish its own precision parameters which more accurately reflect individual laboratory quality control criteria Quality Control IMMAGE 800 Operations Manual A11403 Page 9 6 March 2004 Defining a Control Entering the Minimum Control Definition Entering the Minimum Control Definition When the instrument status is Standby follow the steps below to enter the minimum information to define a control Step Action 1 Select QC from the menu bar Refer to Figure 9 2 2 Select a number beside a blank line under the Control Name column 3 Select Define Edit F2 Refer to Figure 9 3 4 Enter the name of the control in the Control Name field Press Enter The Control Name must be unique and can contain up to 20 alphanumeric characters Spaces are allowed 3 Enter the control lot number in the Control Lot field The lot number can contain up to 12 alphanumeric characters No spaces are allowed Press Enter 6 Select the Sample Type from the options button W The default sample type is serum 7 Select Add Del Chem F1 to select chemistries for the control Refer to Figure 9 4 Use the Page Up gt lt Page Down buttons to view additional chemistries 8 Select the desired chemistries Deselecting a selected chemistry will delete the chemistry from the control definition 9
186. ar code labeled Samples may be placed in any position of any rack of the proper size no Load List is required is not bar code labeled Select Samples from the menu bar Select Load List F9 from the Program Samples screen Type the number s of the rack s programmed for the samples to be processed and Print or display the Load List to identify the proper position for each sample 1 of 3 IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 51 Loading Samples Load Samples Step Action continued 2 Place prepared sample containers into sample racks and verify that each container is placed into a rack which matches the container size four rack sizes are available 13 x 75 mm 13 x 100 mm 16 x 75 mm and 16 x 100 mm seated in the depression at the bottom of the rack and positioned so that bar code labels 1 if used face in the same direction as the rack bar code label 2 Position numbers 3 A012101L EPS Figure 7 15 2 of 3 Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 52 March 2004 Loading Samples 7 Load Samples Step Action continued Confirm the instrument status is in Standby Place the sample rack in any position on the sample carousel Notes Position the rack so that both rack pegs 2 slide into holes in the carousel 1 3 Press the advance b
187. arousel Description Sample Carousel Description The sample carousel is the area of the instrument where the samples are loaded onto the system and where the diluents are placed Samples are loaded onto the system via sample racks All sample cups must be placed on the system using the Sample Cup Holder Kit Refer to Appendix A Part Number List To ensure sufficient sample aspiration do not place sample cups directly into the racks or use 1 0 mL sample cups Sample dilutions are made in dilution wells Refer to Figure 2 6 A011411P EPS 1 Sample Carousel Cover 5 Sample Bar Code Reader 2 Sample Diluent Bottle 6 Sample Carousel Advance Button 3 Sample Rack 7 Background Bar Code Label 4 Dilution Segment Figure 2 6 Sample Carousel System Description IMMAGE 800 Operations Manual A11403 Page 2 10 March 2004 Component List Sample Carousel Component List The following table lists each component of the sample carousel with its function Table 2 4 Sample Carousel Components Number Component Function 1 Sample Carousel Reduces evaporation of sample Cover 2 Sample Diluent Contain sample diluents Bottles 3 Sample Racks Hold sample tubes Refer to Racks in this section of the manual 4 Dilution Segments The various sample dilutions are automatically made in the wells of the dilution segments before delivery to the reaction wheel The disposable dilution segments are placed on the system
188. at have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host 5 Select a function button from the bottom of the screen 6 Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results IMMAGE 800 Operations Manual A11403 Results Recall March 2004 Page 8 7 Recalling Results by Patient Name Introduction Recalling Results by Patient Name Introduction Results can be recalled by Patient Name Recalling by Patient Name Follow the steps below to recall a result by Patient Name Step Action 1 Select Results from the menu bar Refer to Figure 8 1 2 Enter the Patient Name in the Patient Name field NOTICE The results are recalled only when there are exact matches of the last name first name and middle initial A wildcard is allowed for middle initial entry In this case samples are retrieved based on exact matches of the last name first name with any or no middle initial Select the options button lt W gt beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instruc
189. ation status is Cal Failed request either a new calibration or Cal Re enable Refer to Re Enabling Calibration in this section Requesting Calibration Follow the steps below to request calibration Step 1 Action Select Rgts Cal from the menu bar 2 Load the reagent cartridges if necessary Refer to Reagents Loading Unloading Reagent Cartridges in this chapter Select the button s to the left of the chemistries to be calibrated If selecting a chemistry where more than one cartridge of the same lot number is on the reagent carousel e each cartridge of that lot is automatically given a status of Requested only the cartridge with the lowest volume will be calibrated Select Request Cal F4 The Request Calibration screen is displayed Refer to Figure 6 10 Requested Chems appear next to the appropriate Calibrator for the chemistry To run a calibrator as a STAT select the STAT checkbox for the calibrator at the right of the screen ALL chemistries requested for a STAT calibrator will be calibrated STAT A STAT calibrator will be run before any other calibrator or sample Go to Checking and Clearing Racks Reagents Calibration Page 6 26 IMMAGE 800 Operations Manual A11403 March 2004 Requesting and Canceling Calibration Checking and Clearing Racks 8 1996 11 18 Rack Pos Calibrator Requested Chems 1 CAL 1 M583084 IGG IGA IGM C8 C4 fiva
190. ation that is associated with a patient such as name ID age or sex Pause An instrument command which allows results to be generated for all samples in progress and then returns the instrument to Standby status Peltier A temperature control system that heats or cools depending on the ambient temperature Primary tube A tube into which the patient sample is collected Range length bar code The limits of the code length which may be defined for a symbology Reagent name The two to five character abbreviation of the chemistry name Reference interval normal range A user defined range consisting of low and high values that are used to flag patient results as low or high IMMAGE 800 Operations Manual A11403 Glossary March 2004 Page 5 of 6 Replicates Replicates The number of repetitions performed for a test or sample Secondary tube A tube which contains a portion of patient sample control or calibrator from another container Slope A value by which a result is multiplied Special character Any displayable or printable keyboard character that is not an alphanumeric character including the following 19 4 960 amp z eV IC i 7 Standby An instrument mode where all motion is stopped and motors are turned off Start Stop bits Synchronization method that signals the start and end of data transmission in serial communication The Data bits are preceded by the Start bit and followed by
191. atus must be in Standby in order to proceed with the steps below to change the lot or position of a buffer or diluent Step Action 1 Select Rgts Cal from the menu bar Select Buffer Diluent F3 Refer to Figure 6 6 Select the options button lt W gt beside the desired position 2 3 4 Select the desired buffer or diluent to place in the position Press OK OR Select Cancel to return to the Reagents Status Calibration Status screen without selecting a buffer or diluent Enter the buffer or diluent lot number Repeat steps 3 5 for each buffer and diluent to be loaded Select OK to accept any changes made OR Select Cancel to return to the Reagent Status Calibration Status screen without entering any changes Follow Replacing the Same Lot in this section to place bottles on the carousel s NOTICE Recalibration of affected chemistries may be necessary when buffer or diluent lots are changed Reagents Calibration Page 6 10 IMMAGE 800 Operations Manual A11403 March 2004 Loading Clearing Buffers and Diluents Replacing the Same Lot Replacing the Same Lot The instrument status must be in Standby in order to proceed with the steps below to replace the same lot of buffer or diluent in the same position Step Action 1 Mix each buffer or diluent bottle by inversion remove the screw cap 2 Check each container for bubbles and remove bubbles
192. atus screen shows Pausing Load Samples and the estimated time period before you can add or remove samples The time counts down in 5 second increments to zero OR Select the lt Cancel gt button to cancel the pause request This will not affect the current run Refer to Figure 7 17 Wait until the OK to load samples message appears on the screen Refer to Figure 7 18 AN CAUTION To avoid personal injury DO NOT load or remove samples until the OK to load samples message appears on the screen When the message appears select OK The system status changes to Pausing OK to load sample 1 of 2 Sample Programming Page 7 58 IMMAGE 800 Operations Manual A11403 March 2004 Pausing to Load Samples 7 Canceling a Pause Step Action continued 5 Advance the sample wheel and load samples NOTICE The amount of time to load new samples and to resume the run depends on the number of samples being processed If a small number of samples are being processed there may not be enough time to resume the run In this case the sytem will return to Standby Select RUN to restart the system 6 Go the the Main screen and select RUN The system status will change to Resuming and Run A CAUTION To avoid personal injury DO NOT load samples once the RUN button is selected 2 of 2 puu AG eRIu LLILLLEL NLDe Pausing OK to load samples Host Of
193. bbreviation Explanation Action Message El No AGXS Data No Antigen Excess Data CALL BECKMAN COULTER Points CLINICAL SUPPORT E2 No AGXS Data No Antigen Excess Data CALL BECKMAN COULTER Points High CLINICAL SUPPORT E3 Motion Error Motion Error 1 Remove any obstructions from moving parts 2 Home system 3 Follow Event Log directions to display the Motion Error Event Log 4 Restart the run Report any failed devices to Beckman Coulter Clinical Support E4 No Dil Wells Out of Dilution Wells From Status menu check status of dilution segments and replace segments showing zero 0 status E5 RGT Cart N A Insufficient Chemistry If reagent volume is low load a new Reagent and or reagent cartridge and Read Reagents Uncalibrated Reagent from the Rgts Cal screen If reagent is uncalibrated calibrate E6 Back to Back Excessive Calibrator Repeat calibration Replicate Spread E7 Scale Fct Scale Factor Range Error Repeat calibration E8 Unstable RXN Unstable Reaction CALL BECKMAN COULTER CLINICAL SUPPORT E9 RGT Cart N A Insufficient Chemistry Reagent not on board Load a new Reagent reagent cartridge and Read Reagents from the Rgts Cal screen E10 Chk Optics Optics Error for AGXS CALL BECKMAN COULTER excessive Q Values CLINICAL SUPPORT 10 Code Segment FATAL CALL BECKMAN COULTER CRC Failure CLINICAL SUPPORT 1 of 21 IMMAGE 800 Operations Manual A11403 March 2004 Utilities Page 10 23 Errors Error Ta
194. bel IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 11 Symbols and Labels Caution Biohazard Caution Biohazard This cautionary label is located between the sample and reagent carousels Operate the system with all covers in place CAUTION ney TO REDUCE RISK OF PERSONAL INJURY X OPERATE ONLY WITH ALL COVERS IN PLACE A 01364C EPS 270 456161 A Caution Biohazard Label Bar Code Caution This label is placed on the cover of any laser based bar code reader Do not stare into laser light beam when cover is open or removed CAUTION LASER LIGHT ACCESSIBLE WHEN COVER IS OPEN OR REMOVED DO NOT STARE INTO BEAM 270 456357 B A010640L EPS Bar Code Caution Label Laser This label is placed near any opening through which a bar code reading beam emits Avoid exposure to laser light emitted from the opening AVOID EXPOSURE LASER LIGHT IS EMITTED FROM THIS APERTURE 270 456356 B S A 01377C EPS Laser Caution Label Class Il Laser Caution This cautionary label is located between the sample and reagent carousels Do not stare into laser light beam CAUTION DX LIGHT DO NOT STARE INTO BEAM 670 nm 1 mW CLASS Il LASER PRODUCT 270 456355 B A 01376C EPS Class II Laser Caution Label General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 12 March 2004 Class 111 B Laser Caut
195. ber List Description Part Number Bar Code Reader 470274 Cable Assemblies Ethernet to computer Ethernet Coax Cable ext 963781 Computer to printer Printer Cable 970207 Cable Assembly Crane Flex 470221 Cap Assemblies External Wash 470586 Waste 470728 Carousels IMMAGE Reagent 470379 Sample 470519 CD ROM Chemistry Information IMMAGE Immunochemistry Systems English Danish French German Greek Italian Portuguese Spanish and Swedish 474616 Chinese English and Japanese 389143 CD ROM Product Manuals IMMAGE 800 Immunochemistry System English Danish French German Greek Italian Portuguese Spanish and Swedish A12551 Chinese English and Japanese A12554 Chemistry Protocol Diskette 470632 Computer 470737 Cords Power 120 volt U S and Japan 928305 220 volt European 897191 220 volt Printer Power Adaptor Cable 469342 220 volt Adaptor Cable shield 2 5 meter 757955 Cover IMMAGE Sample Carousel 470560 Cups sample 0 5 mL package of 100 663773 2 0 mL package of 100 652730 1 of 4 IMMAGE 800 Operations Manual A11403 March 2004 Part Number List Page A 1 Table A 1 Part Number List continued Description Part Number Cuvette Sectors IMMAGE package of 13 470706 Cuvette IMMAGE Reference 470704 Dilution Segments IMMAGE package of 100 470708 Diskettes Formatted Blank
196. ble Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message Ell Chk Optics Optics Error excessive 1 Dilute and rerun sample scatter 2 Check and remove bubbles from reagent cartridge sample container E12 Chk Optics Excessive Q Values 1 Check and remove bubbles from Detected reagent cartridge sample container 2 Check and remove bubbles from buffers and diluents 3 Rerun sample E13 Chk Optics Optics Error Divide by CALL BECKMAN COULTER Zero or Log 10 Domain CLINICAL SUPPORT El4 Chk Optics Optics Error for AGXS CALL BECKMAN COULTER Divide by Zero or Log 10 CLINICAL SUPPORT Domain E15 Chk Optics Optics Error Bad Data CALL BECKMAN COULTER CLINICAL SUPPORT El6 Chk Optics Optics Error for AGXS CALL BECKMAN COULTER excessive scatter CLINICAL SUPPORT E17 Chk Optics Optics Error for AGXS CALL BECKMAN COULTER Bad Data CLINICAL SUPPORT E18 RGT Temp OR Reagent Temperature Out 1 Verify reagent fans are turning of Range 2 Close reagent cover 3 Check Status Monitor to verify reagent temperature is within range E19 Anlg Gnd OR Analog Ground Out of CALL BECKMAN COULTER Range CLINICAL SUPPORT E20 Ref Volt OR Reference Voltage Out of CALL BECKMAN COULTER Range CLINICAL SUPPORT E21 PSVE PS OR P5VE Power Supply Out CALL BECKMAN COULTER of Range CLINICAL SUPPORT E22 P12V PS OR P12V P
197. ble 504 Sample Section WARNING Home system is Inoperable 505 DAS Reload WARNING 1 Select Utils Error 2 Select lt 10 gt Reload DAS code 3 Reboot instrument 801 Level Sense WARNING 1 Check and remove bubbles from Failure at Buffer buffer Bottle 2 Observe that reagent probe enters buffer 3 Rerun sample 802 Level Sense WARNING 1 Check and remove bubbles from Failure on Reagent Compartment A Reagent A at 2 Rerun sample Position 803 Level Sense WARNING 1 Check and remove bubbles from Failure on Reagent Compartment B Reagent B at 2 Rerun sample Position 8 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 30 March 2004 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 804 Level Sense WARNING 1 Check and remove bubbles from Failure at Diluent diluent Bottle 2 Rerun sample 805 Level Sense WARNING CALL BECKMAN COULTER Failure at CLINICAL SUPPORT Dilution Well 806 Level Sense WARNING 1 Check and remove bubbles from Failure at Sample sample Position 2 Verify sufficient sample volume is present 3 Rerun sample 811 Level Sense WARNING CALL BECKMAN COULTER False Trigger at CLINICAL SUPPORT Buffer Bottle 812 Level Sense WARNING CALL BECKMAN COULTER False Trigger on CLINICAL SUPPORT Reagent A at Position 813 Level Sense WARNING CALL BECKMAN
198. ble 10 4 Monthly Maintenance Clean Perform Exterior surfaces Record the cycle count Fan Filters Cleaning Surfaces Wipe all exposed surfaces on the system and table surfaces with a fresh 10 bleach solution Cleaning Filters To clean fan filters perform the following the steps Step Action 1 Grasp and pull both fan covers 1 from right side of instrument and remove filters 2 A010022P EPS Figure 10 6 1 of 2 Utilities Page 10 12 IMMAGE 800 Operations Manual A11403 March 2004 Monthly Maintenance Procedures Cycle Count Step Action continued 2 Remove filter 1 from the left side of the instrument Figure 10 7 3 Wash the filters with deionized water to remove lint or clean the filters with pressurized air if available 4 Use paper towels or lint free tissues to dry the filter Reinsert filters and replace covers 2 of 2 Cycle Count The cycle count is the total number of tests started by the IMMAGE 800 Obtaining the cycle count is necessary to determine the number of tests performed Follow the steps below to obtain the cycle count Step Action 1 Select Status from the menu bar 2 Select lt 3 gt Instrument Status Monitor from the Status screen OR Type 3 in the Option No field and press Enter 3 Record the results on the maintenance log sheet IMMAGE 800 Operations Manual A11403 Utilitie
199. blish a calibration scale factor based on the assigned calibrator target value The calibration scale factor is used to adjust the measured rate response to equal the theoretical response Protein Calibration Curve When the antibody concentration is constant the rate response will increase as antigen concentration increases The maximum rate response occurs when the antibody and antigen are in optimal proportions As antigen concentration increases further the rate response will then progressively decrease The regions at lower and higher antigen concentration are called antibody excess and antigen excess respectively Drug Calibration Curve When the concentration of conjugate and specific antibody are constant the rate response will decrease as drug hapten concentration increases The maximum rate response occurs when the drug is absent and the maximum amount of antibody is available to react with the conjugate Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3 12 March 2004 CHAPTER 4 System Power On Off Table of Contents System Power ON OFF seca onc bees o ds 4 2 System Power ON dla feces id cto detecte Dto oce a clara 4 2 System POWER OE RR CH 4 4 Database Recovery A Ad 4 5 Software Installation Instructions 1 eee ee RG ut Stes 4 6 IMMAGE 800 Operations Manual A11403 System Power On Off March 2004 Page 4 1 System Power On Introduction System Power
200. bol displayed above is a reminder that all safety instructions should be read and understood before installation operation maintenance or repair of this instrument When you see the symbol on other pages pay special attention to the safety information presented Observance of safety precautions will also help to avoid actions that could damage or adversely affect the performance of the instrument Other symbols may also be displayed on the equipment These are reproduced and described in the Operating Precautions and Hazards section Safety During Installation and or Maintenance This instrument is designed to be installed by a Beckman Coulter Field Service representative Installation by anyone other than authorized Beckman Coulter personnel invalidates any warranty covering the instrument Any servicing of this equipment that requires removal of any covers can expose parts which involve the risk of electric shock or personal injury Make sure that the power switch is turned OFF and that the instrument is disconnected from the main power source Refer such maintenance to qualified service personnel Electrical Safety To reduce the risk of electrical shock this instrument uses a three wire electrical cord and plug to connect to earth ground Make sure that the matching wall outlet receptacle is properly wired and earth grounded Never remove or install any circuit board connect or disconnect any plug or cable while the power is ON
201. brator bar code card s on an EMPTY rack s Refer to Figure 6 2 2 Open the sample compartment cover Rotate the sample carousel by pressing the advance button on the instrument Place the rack s on the sample carousel Close the sample compartment cover Select Rgts Cal from the menu bar Select Read Cards F8 Select lt OK gt to start the bar code read and go to Step 8 OR Select Cancel to return to the Reagent Status Calibration Status screen without reading the bar code cards SEND my BR Ww 1 of 2 IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 5 Loading Reagent Calibrator Bar Coded Parameters Loading Bar Code Cards Step Action continued 8 If the bar code card is the screen will display successfully read the Rack reagent calibrator Name and Lot for each scanned bar code card in the Cards Read window misread an error message appears with the rack and position where the bar code was misread Refer to CHAPTER 10 Utilities Troubleshooting To exit the Cards Read dialog box even if the bar code read is not finished select OK Figure 6 2 2 of 2 A010072P EPS Loading Reagent Calibrator Bar Code Cards on a Rack Reagents Calibration Page 6 6 IMMAGE 800 Operations Manual A11403 March 2004 Displaying Deleting Reagent Parameters Introduction
202. buttons to access additional controls Select QC Log F5 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select lt OK gt to choose the default Use Tab to toggle between fields Select lt OK gt to continue OR Select lt Cancel gt to exit Select the result by selecting the check box next to the result Select Delete Result F3 Enter a maximum of 3 alphanumeric characters in the Operator ID field Press Enter 1 of 2 Quality Control Page 9 24 IMMAGE 800 Operations Manual A11403 March 2004 QC Log Action Log Step Action continued 7 A message appears to confirm the deletion of the result QC result will be deleted Backup is suggested Delete QC result Select lt OK gt to delete the result OR Select Cancel to exit without deleting the result The deleted result is still displayed within the QC Log It is marked as deleted with the initials of the operator who deleted it However the data point will no longer be included in any calculations or summaries 2 of 2 Action Log An Action Log comment to be associated with a particular result can be defined by the operator The instrument status must be in Standby in order to proceed with the steps below Follow the steps below to associate a comment with a result Step Action 1 From the Quality Control screen select the control d
203. by rate turbidimetry Inhibition immunoprecipitin reaction detected by rate turbidimetry Reagent Expiration Date Date in order as defined in Date Setup Reagent will be flagged on reports as expired after this date 1 of 2 IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 75 Defining a UDR Chemistry Description of Definition Fields Table 5 7 Protocol Definition Fields Page 1 continued Field Entries Allowed Function Tests per Cartridge 1 300 Identifies the number of tests available in the reagent cartridge AGXS Enabled Select check to enable Allows usage of AGXS Limit field 2 of 2 The following table describes the protocol fields of the Define Edit User Defined Chemistry screen Page 2 Refer to Figure 5 33 Table 5 8 Protocol Definition Fields Page 2 Field Entries Allowed Function Buffer BUF 1 to 4 or Identifies type of buffer used in BUF 10 to 15 test Diluent DIL 1 to 4 or Identifies type of diluent used in DIL 10 to 15 test Sample or Dilution Volume 3 uL to 21 uL or 3 uL to 75 uL depending on the sample dilution Sample or dilution volume dispensed to reaction cuvette Reaction Buffer Volume 0 or from 195 uL to 300 uL Reaction buffer volume dispensed Compartment A Volume Refer to Figure 5 34 5 uL to 235 uL Reagent volume aspirated from cartridge compartment A C
204. calibration 5 108 Defining an AGXS limit llus 5 80 Editing the time range on a robust means data curve T NU CE EE HE d DEMO 5 112 Plotting a robust means data curve 5 109 Programming a single point UDR calibration 5 98 Recommended order for UDR AGXS flagging limit use O at u Tah iras 5 79 Using the mouse Clicking e Abe AE wah recs DI VS 2 34 Dragging icons Re Se ee ee a d 2 34 Pointer neri able iege epe da 2 34 V METTE coed a he Mineo 2 14 Variables e ticket E Ee ds 7 37 Setting the variables o o o oo 7 37 Verifying the cal status of reagent parameters 6 19 IMMAGE 800 Operations Manual A11403 Index March 2004 Page vii of vii
205. calibration Refer to Re Enabling Calibration in this chapter of 2 Reagents Calibration Page 6 24 IMMAGE 800 Operations Manual A11403 March 2004 Cartridge Specific Calibration Calibration Events If Then continued a new reagent lot calibration is _ recalibrate with a fresh cartridge greater than desired predetermined number of tests remaining remove cartridge specific cartridge place a fresh cartridge on carousel request and recalibrate chemistry replace used cartridge on carousel after successful calibration specific calibration information select the options button lt W gt beside Cal ID for is desired the calibrator of the specific chemistry The Calibration Information screen will indicate whether the calibration was cartridge specific 2 of 2 IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 25 Requesting and Canceling Calibration Introduction Requesting and Canceling Calibration Introduction Reagent and calibrator bar code parameters must be loaded prior to requesting a calibration Refer to Reagents Loading Reagent Calibrator Bar Coded Parameters in this chapter Calibration must be requested for a reagent lot which has a status of Uncalibrated before patient samples can be run with that reagent lot Calibration may be requested regardless of the current calibration status for any reagent lot If the calibr
206. can be edited Data storage and retrieval through the Archive Restore screen Data recall through the Results Recall screen Patient information through the Sample Demographics screen Data output in Japanese including printer output of reports and results Host interface with the Laboratory Information System LIS to transfer Japanese characters A basic Kanji character dictionary and an expanded dictionary to include additional Kanji characters for names places and technical medical terms Pop up messages including error messages are displayed in mixed scripts of Kanji Hiragana Katakana and English as appropriate for the message Barcode labels parameters and data will be read and stored in English Reagent lot parameter data will be stored and displayed in English Note Japanese language capability requires a Japanese keyboard NOTICE Other languages will be disabled when the IMMAGE 800 is running in the Japanese language In order to access another language the IMMAGE 800 software must be reinstalled It is recommended that the database be archived before switching languages IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 85 Computer The Japanese Keyboard Computer The Japanese Keyboard Figure 7 25 depicts the IBM Japanese terminology translation keyboard used with the IMMAGE 800 The function of the normal keyboard keys For example Esc Page Up
207. ce Procedures aou cde dates ictus teg VII n dug ade geass ep tase DU ce du EAE DRE 10 7 Daily Maintenance Procedures ie 10 8 Monthly Maintenance Procedures A 10 12 As Indicated Maintenance ia 10 14 TroubleshoDU ub uo m a da 10 22 ETTO S ao 10 22 Eyent Lol nudos 10 44 Callable Diagnostics a 10 50 A uita estudia desees ub testate piu tan ead ats es eem piae aes 10 53 TAC UO RES eode sumet tinent uta stan eae eae cn ea 10 64 Pall Internal Wash Bottle ria 10 67 Calibrate Touch Screen ira 10 68 Replacing P rts User Servicing ii 10 70 uci m 10 70 SAS sor PEPPER 10 71 sample and Reagent Crane Mixer Paddle viii eei ie e b cad din dias 10 72 sample and Reagent Crane Probe deo de 10 73 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 1 Overview Introduction Utilities Overview Introduction Utilities is divided into three sections Maintenance Troubleshooting and Replacing Parts User Servicing These tasks are designed for performance at the operator level Maintenance This section will be helpful in performing required maintenance essential to obtain accurate results meet inspection and accreditation requirements This section explains how to perform daily maintenance perform monthly maintenance perform as indicated maintenance prime system fluids wash cuvettes Troubleshooting This section will be helpful in diagnosing instr
208. chemistry system It contains essential non lot specific information about how to run each chemistry When to Load the Protocol Diskette The chemistry protocol diskette is loaded when the IMMAGE 800 is installed When new chemistries become available a new diskette is provided Loading the Protocol Diskette The instrument status must be in Standby in order to proceed with the steps below to load the chemistry protocols onto the hard drive of the computer Step Action Select Setup from the menu bar Select 16 Chemistry Protocol Diskette from the Setup screen Insert the chemistry protocol diskette into the floppy diskette drive Refer to CHAPTER 2 System Description Select OK if the database has been archived Select Cancel to return to the Setup screen without loading the diskette OR If the diskette is the screen successfully read unsuccessfully read returns to the Setup menu displays an appropriate error message Refer to CHAPTER 10 Utilities Select Main to return to the main display System Setup Page 5 66 IMMAGE 800 Operations Manual A11403 March 2004 Instrument Serial Number Setup Introduction Instrument Serial Number Setup Introduction The serial number of the instrument is entered through the Instrument Serial Number option The instrument serial number will be printed on all reports How to Enter the Serial Numbe
209. code ID entry to move between fields 3 Select lt OK gt to exit the screen and save the Control IDs OR Select lt Cancel gt to exit the screen without saving the Control IDs Defining More Information for a Control After entering the minimum information to define a control follow the steps below to further define a control Step Action 1 Enter the constituent code a quality assurance program code beside the chemistry it corresponds to in the Constituent Code field 4 alphanumeric characters type leading zeroes if they are part of the constituent code 2 Select any icon from the menu bar to exit the Define Edit Controls screen and save the control definition IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 11 Editing a Control Introduction Editing a Control Introduction The assigned mean standard deviation SD constituent code and control ID of a previously defined control can be edited In addition individual chemistries can be added or deleted Editing Precautions When editing control information the following should be considered Changing the mean and or SD may affect subsequent QC statistical data Changing previously defined mean and or SD to zero will set the mean to zero and the SD to 99999 Subsequent data points will be compared to the new mean and SD Accessing a Control to Edit When the instrument status is Standby follow the
210. ct View F1 The Calculations screen for the first calculation selected will be displayed Refer to Figure 5 11 4 Select the check box beside Enable Calculation to enable the calculation displayed The default for all calculations is disabled unchecked 1 of 2 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 29 Calculations Setup Enabling a Calculation Step Action continued 5 Select Prev Calc F9 or Next Calc F10 to move to another Calculations screen OR Select Cale Summary F1 or an icon from the menu bar to return to the Calculations Summary screen 6 If the Excretion Rate Calculation is enabled go to Selecting Urine Chemistries for Excretion Rate Calculations 2 of 2 Samples Results Calculations Summary Number s LO o Opt Calculations Enable Calculations 1 APA APB ALB INDEX 2 APB APA IGG INDEX 3 KAP LAM IGA INDEX 4 PRO NAP IGM INDEX 5 PRI PHE CUS TOMCALC 61 6 EXCRET RATE CUSTOMCALC 82 T CSF INDEX 8 IGG SYN RATE View y Select Def ine Delete Def ine Edit ar Fi E014091S EPS Figure 5 10 Calculations Summary Screen Status Calculation Name Enable Calculation vi Calculation Formula Sample Iype 2 2 Calc Summary Fi E010306S EPS Figure 5 11 Calculations Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5
211. cters Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric the individual Sample IDs to be recalled in Sample IDs the Sample IDs field separated by a comma all Sample IDs 0 in the Range field Press Enter Type Zzzzzzzzzzzzzzz in the Thru field 3 Select the options button lt W gt beside the Data Source field 1 of 2 IMMAGE 800 Operations Manual A11403 Results Recall March 2004 Page 8 3 Recalling Results by Sample ID Recalling by Sample ID Step Action continued 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host 5 Select a function button from the bottom of the screen 6 Refer to Displaying Recalled Results on the Screen and Printing a Recalled Result in this chapter to display or print results Initializing Samples Results Recall Results Sample ID s Range Rack s Patient ID Patient Name Run Date Time From Results Source
212. d Table 4 1 Information Changed After Power is Restored Information Screen Change Dilution Segments dialog box All segments go to 0 wells available Sample Carousel Status monitor Screen is blank Reagent Status Calibration Status screen Screen is blank Calibration requests are deleted Sample Load List Samples which were In Process become Incomplete Instrument Status Monitor Continuously updates all parameters Simulated calibrations Calibration status changes to Failed Printing Printouts will stop From Results Recall request printouts of patient and control reports if needed Calibration reports cannot be recalled for printing IMMAGE 800 Operations Manual A11403 System Power On Off March 2004 Page 4 5 Software Installation Instructions Introduction Software Installation Instructions Introduction The IMMAGE 800 System Software is preloaded on the hard disk The Installation Diskette and System Software CD ROM are provided in case the software is reloaded Preparation The following are used during the installation Installation Diskette CD ROM Storage of Software Store the Diskette and CD ROM in an area away from electrical and magnetic interference to prevent damage Avoid extreme temperature Installing the Software Follow the steps below to install reload software Step 1 Action Complete backup of the database to a floppy diskette Power off the
213. d any Pending tests are deleted from an Incomplete control sample program Exception if controls are programmed by bar code the system will try to run Pending tests from an Incomplete sample Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 38 March 2004 Programming a Control 7 Control Chemistries Control Chemistries When a control is selected only the chemistries defined for the Control Name are available The defined chemistries can be selected and deselected from the Program Control screen A manually programmed control will always be programmed for the chemistries that were selected last Example e Control X is defined for IGG IGA and IGM IGA and IGM are deselected before the control is run The next time the control is programmed only IGG will be selected Bar Coded Controls Bar code labels can be used to identify control samples The bar code must encode a defined Control ID If the same control is repeated in different positions during a run each control sample must have a different bar coded Control ID All defined control chemistries will be run automatically when a Control ID is identified by bar code Exception the system will try to run Pending tests from an Incomplete sample NOTICE After pausing or stopping the system completed bar coded control samples will be run again when the system is started Host Programming of a Control If a control is prog
214. d clear the UDR calibration rack Refer to Clearing a UDR Cal Rack in this chapter IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 107 Approving a Calibration Approving a Single Point UDR Calibration User Def ined Model Option Number 4 T First Order Polynomial E Second Order Polynomial 3 Third Order Polynomial Pa Four Parameter Logistic OK Cancel E014061S EPS Figure 5 53 User Defined Model Dialog Box Approving a Single Point UDR Calibration The instrument status must be in Standby to proceed with the steps below to approve a UDR calibration model The single point UDR Calibration Result report must show at least one instrument response IR for the single point calibrator level If not a calibration run must be repeated Step Action 1 From the User Defined Chemistries screen Figure 5 28 select the UDR chemistry and Approve Cal F5 NOTICE If a single point calibration is approved with a scale factor that is not within the range 0 6667 2 0 the sample run will produce no concentration results In this case first rerun the single point calibration If the results are the same run a multi point calibration Target instrument response 50 for calibration update level 2 Select Approve Update F1 to approve the scale factor Refer to Figure 5 52 The only curve fit model available is the approved multi point calibrated curve fit model Note Th
215. d and saved the user must log in and perform a password setup procedure This password protection feature is recommended for security purposes The password setup is used to identify specific information such as who logged in which field was updated what screen was entered what field was changed This and other information are described in the Display Events log The password setup is described in the following steps Step 1 Action Select the Password Setup box near upper right corner of the User Defined Chemistries screen Refer to Figure 5 28 The User Log in screen appears Refer to Figure 5 29 Note that the Username field defaults to ADMIN Enter ADMIN in the Password field and select lt OK gt OR Select lt Cancel gt to return to the User Defined Chemistries screen If lt OK gt was selected above the UDR User Setup Password Protection Mode screen appears Refer to Figure 5 30 This screen is used to add or delete a user Up to 16 users are allowed Password protection is enabled by default 1 e the Password Protection Mode box is checked If the Password Protection Mode box is disabled not checked the password protection feature is not available i e no prompt after Define and Save To add another user select a new user name number Then select Define Edit User and proceed to Step 4 A Define Edit User screen appears Refer to Figure 5 31 Enter a new user name in the Usernam
216. d on the IMMAGE 800 alignment screens as Step 1 for each alignment procedure These prerequisites are required when aligning a new system or realigning an entire system The prerequisites can be ignored when performing an alignment of a specific functional area IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 53 Alignment Straightness of the Sample and Reagent Probe from front Straightness of the Sample and Reagent Probe from front Follow the steps below to verify the straightness trueness of the Sample Probe or Reagent Probe looking at the front of the probe The instrument status must be in Standby Step Action 1 Verify that the Sample or the Reagent Crane Mixer Paddle is straight Refer to Callable Diagnostics Sample Stir Motor and Reagent Stir Motor in this chapter Rotate the Crane Assembly so that the crane assembly is facing towards the front of the instrument Raise the probe guard 1 to expose the probes and verify that the probe is aligned with the Crane Mixer Paddle 2 Refer to Figure 10 23 If the probe is then aligned with the Crane proceed to Straightness of Sample and Mixer Paddle or Reagent Probe from the side not aligned with the Crane adjust the probe by gently bending it to Mixer Paddle align with the Crane Mixer Paddle LLL ADHOT2P EPS Figure 10 23 Utilities Page 10 54 IMMAGE 800 Operations
217. d or by selecting the appropriate button in the chemistry menu The maximum number of chemistries which can be selected is the number of chemistries configured in the chemistry menu Selecting a Chemistry by Number Follow the steps below to select a chemistry by number Step Action 1 Select Samples from the menu bar 2 Choose the Chem No s field 3 Type the desired chemistry number s in the Chem No s field Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 4 Press Enter Selecting a Chemistry from Chemistry Menu Follow the steps below to select a chemistry from the chemistry menu Step Action 1 Select Samples from the menu bar 2 Select the button corresponding to the desired chemistry Chemistries with numbers greater than 45 can be accessed by paging down NOTICE If both panels and individual chemistries are selected for a sample their Sample Types and any off line dilutions must be the same After Chemistry Selection After a chemistry is selected the button is highlighted in the chemistry menu Sample Programming Page 7 18 IMMAGE 800 Operations Manual A11403 March 2004 Selecting Chemistry Tests by Chemistry 7 Canceling a Chemistry Canceling a Chemistry A selected chemistry can be canceled by deselecting the button from the chemistry menu The highlight is removed A ch
218. de card Requested Calibration status of a requested chemistry that will become a cartridge specific calibration Cartridge Specific Calibration Criteria The criteria for cartridge specific calibration is defined as follows Reagent bar code card indicates the potential for this classification Reagent cartridge on carousel contains less than predetermined number of tests remaining Calibration is requested for a specific chemistry Reagents Calibration Page 6 22 IMMAGE 800 Operations Manual A11403 March 2004 Cartridge Specific Calibration Calibration Status If Then more than one cartridge on carousel has less than the predetermined number of tests remaining the system uses the cartridge with the least number of tests remaining two or more cartridges with the same number of tests remaining are on the system at the same time the system uses the cartridge loaded at the lowest carousel position all the cartridge specific calibration criteria are met when a calibration is requested the system automatically runs a cartridge specific calibration on the appropriate cartridge Calibration Status Each cartridge with a cartridge specific calibration will have its own calibration values There can be only one cartridge specific calibration per cartridge Any time the same cartridge is recalibrated for cartridge specific use the previous cartridge
219. ding Codabar labels with large gaps between bar code characters The normal intercharacter gap cannot exceed one character element Fixed Code Length If the sample IDs being used are all of the same length Fixed Code Length may be enabled to ensure that only one length of sample ID is accepted Define Code Length When Fixed Code Length is enabled the code length may be defined as from 1 to 15 characters IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 51 Bar Code Label Specifications Industry Standards Bar Code Label Specifications Industry Standards American National Standards ANSI X3 182 1990 American Society for Testing Materials ASTM E1466 92 Symbol Size Maximum overall length 60 mm 2 36 inch Includes bar code symbol with 5 mm 0 20 inch quiet zone at each end Minimum height 10 mm 0 40 inch Symbol Content Maximum of 15 characters Recommended symbol content printed on label in human readable form Square bracket or percentage sign 96 dollar sign comma quotation mark ampersand amp asterisk semi colon question mark back slash V caret tilde or piping bar I cannot be used as a character Margin of Reading Accuracy Bar code symbol narrow element width of 0 19 to 0 51 mm 0 0075 to 0 02 inch Wide element to narrow element ratio of 2 2 1 to 3 0 1 Placing a Tube into a Rack Tubes should be seated to the bottom of th
220. e e 1 5 years on the first line 6 14 years on the second line 15 175 years on the third line Age ranges cannot overlap Example of overlapping age ranges e 1 5 years e 5 175 years Defining Editing Intervals and Ranges The instrument status must be in Standby in order to proceed with the steps below to define reference intervals and critical ranges Step Action 1 From the Reference Interval Critical Ranges screen type the low age in the Low field Press Tab Refer to Figure 5 8 Type the age unit in the field next to the low age Press Enter Type the high age in the High field Press Tab Type the age unit in the field next to the high age Press Enter NM BB Ww ry Type the low and high reference interval numbers in the Low and High Reference Interval fields The low reference interval number must be less than the high reference interval number rounded to the nearest hundredth Example Acceptable entry Low 5 06 High 5 07 Unacceptable entry Low 5 061 High 5 063 6 Optional entry Type the low and or high critical range numbers in the Low and or High Critical Range fields The critical range numbers must be outside of the reference interval 1 of 2 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 19 Reference Interval Setup Selecting the Default Step Action continued 7 Repeat Steps 1 6 for additional interval and range d
221. e Entries may be from one to nine Enter the number of replicates to be run for the Update Level in the Replicates field Entries may be from one to nine Enter the concentration value in each of the Cal Setpoint fields The concentration values must be in ascending order with Level 1 being the lowest concentration Each field entry is limited to seven digits or six digits with a decimal point NOTICE The number of calibration levels limits the type of curve fit model applicable to the UDR Refer to Approving a Calibration Curve Fit Model Descriptions later in this chapter Select Save F9 to save the protocol and calibration information OR Select Cancel F10 to exit the screen without saving the protocol Go to the User Defined Chemistries screen Figure 5 28 and select Chem Config F9 to configure the UDR chemistry Refer to Configuring the Chemistry Menu in this chapter From the Chemistry Configuration screen select UDR Main F9 to return to the User Defined Chemistries screens System Setup Page 5 84 IMMAGE 800 Operations Manual A11403 March 2004 Deleting UDR Chemistries Removing a UDR Chemistry from the Chemistry Menu Deleting UDR Chemistries Removing a UDR Chemistry from the Chemistry Menu This function removes the UDR chemistry from the chemistry configuration menu from any configured control and from any configured panel Refer to Configuring the Chemistry Menu Deleting a
222. e The light source for the rate turbidimeter is an light emitting diode LED at a wavelength of 940 nm Turbidimetric measurements are made at 0 from the incident beam as shown in Figure 3 1 A010323L EPS 1 LED light source turbidimetric 6 Nephelometric detector 2 Laser light source nephelometric 90 angle to incident laser beam 3 Focus lens 7 Laser light bounces into light trap 4 Beam splitter 8 Turbidimetric detector 0 angle to the 5 Reaction cuvette incident LED beam Figure 3 1 IMMAGE 800 Rate Nephelometer and Rate Turbidimeter Basic Components Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3 2 March 2004 Signal Measurement and Reaction Dynamics Light Scatter Signal Development Signal Measurement and Reaction Dynamics Light Scatter Signal Development During an antigen antibody reaction immunoprecipitin complexes are formed In rate nephelometry the light scattered at 90 increases as the complexes are formed In rate turbidimetry the light intensity at 0 decreases as the complexes are formed This decrease is converted to an increasing scatter signal by the formula light intensity scatter signal Log 10 initial light intensity E011367L EPS Rate nephelometry and rate turbidimetry give the same signal as illustrated in Figure 3 2 A011368L EPS 1 X Increasing time 4 Sample Addition 2
223. e interval will vary depending on the number of controls run The system also monitors the database and reports the remaining hard disk storage space for QC This is displayed on the Quality Control screen just below the menu toolbar Backup should be considered when less than 596 of QC storage space remains IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 31 QC Backup QC Backup QC Backup Follow the steps below to back up QC to a floppy diskette Formatted diskettes must be double sided high density Step Action 1 From the Quality Control screen select QC Backup F8 Refer to Figure 9 10 Select 1 Backup to Disk OR Enter 1 on the Option No field Enter a maximum of 3 alphanumeric characters in the Operator ID field Press Enter Place a floppy diskette into the disk drive Select OK to back up the QC OR Select Cancel to return to the Quality Control screen without archiving the QC NOTICE If Backup is selected the system will format the diskette before doing the backup All existing files will be overwritten When backup is complete a message is displayed asking the operator whether the backed up results should be deleted At the Backup Restore dialog box select OK to continue NOTICE Once the QC data is deleted from the hard disk modifications are no longer allowed Select OK to delete the QC results from the hard disk OR Select
224. e SPACE BAR is pressed the highlighted Kanji character s is replaced by the first character s on the next available candidate list until there are no more choices left Note There can be one 1 or over one hundred 100 Kanji candidates on a case by case basis The maximum number of Kanji choices displayed at any time is nine 9 Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 92 March 2004 Language Conversions 7 Kanji Text Additional Information Kanji Text Additional Information To view the next set of Kanji candidates press the SPACE BAR or the down Y arrow key To view the previous set of Kanji candidates press the up T arrow key The last Kanji character used always appears as candidate number one until the IMMAGE 800 system is rebooted The number of Kanji choices found is displayed to the right of the Kanji choices displayed and the number associated with the numeric order is displayed to the left of the Kanji choices The candidate Kanji character s displayed in the text field is highlighted with yellow until it is approved inserted by the user The candidate Kanji character s is entered into text when the ENTER key is pressed or the selection number for the Kanji choice displayed at the bottom of the screen is entered by the user Note If none of the Kanji character candidates are suitable choosing the 0 option will automatically cause the text to revert back to Hiragan
225. e and calibration runs only For further details refer to Programming Rate Mode and Calibrating a UDR Chemistry in this chapter Refer to the following steps to plot a Robust Means Data Curve Step Action 1 Go to the User Defined Chemistries screen and select a UDR chemistry Refer to Figure 5 28 2 Select Print Plot F10 A User Defined Reports screen appears Refer to Figure 5 54 3 From the User Defined Reports screen select option 6 Plot Robust Means Data Curve and OK The Plot Robust Means Data Curve window appears as shown in Figure 5 55 OR Select Cancel to return to the User Defined Chemistries screen 4 From the Plot Robust Means Data Curve window enter the rack number position number and replicate number Select Plot to plot the curve A typical Robust Means Data Curve is shown in Figure 5 56 OR Select Exit to return to the previous screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 109 Approving a Calibration Plotting a Robust Means Data Curve Host Off 02 06 2004 12 08 Ei Calibeation Report 4 Single Point Update Calibration Results Report 5 Singte Point Update Calibration Report 6 Plot Robust Means Data Curve Enter a Number from 1 to 3 E011437S EPS Figure 5 54 User Defined Reports Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 110 March 2004 Approving a Calibration Plotting a Robust Mean
226. e comment IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 61 Demographics Setup Introduction Demographics Setup Introduction The fields which are accessible in the demographics screen of sample programming can be selected Refer to CHAPTER 7 Programming a Sample Entering Patient Demographics Selecting Fields to be Displayed in Sample Programming The instrument status must be in Standby in order to proceed with the steps below to select fields for display in sample programming Step Action 1 From the Setup screen select lt 13 gt Demographics Setup Refer to Figure 5 24 2 Select the check boxes beside the fields to be accessible in the Demographics screen of sample programming Checked fields will be accessible unchecked fields will not be accessible in sample programming 66 27 1996 09 20 put Samples Results Status Demographics Setup Last Name Ej Doctor First Name f Middle Initial 4f Location Date of Birth E Collection Date Y Collection Time of Collected By Ef Enable Disable the demographic field of choice E010230S EPS Figure 5 24 Demographics Setup Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 62 March 2004 Demographics Setup Restoring Defaults Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore defaults to the Demographics Setup St
227. e day displayed above the dd if needed delete the currently displayed day type the correct day in its place The digits for day can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by entered for the fourth day of the month 5 Correct the year displayed above the yyyy if needed delete the currently displayed year type the correct year in its place The digits for year must contain all four digits For example 1996 may be entered but not 96 6 Select OK to save the changes OR Select Cancel to return to the Date and Time screen without saving the changes Change Date Leo 19 1996 mm dd YYYY Cancel E010225S EPS Figure 5 19 Change Date Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 47 Date and Time Setup Changing the Time Changing the Time The instrument status must be in Standby in order to proceed with the steps below to change the time Step Action 1 From the Setup screen select lt 9 gt Date Time Refer to Figure 5 18 2 Select Change Time F3 Refer to Figure 5 20 3 Correct the hour displayed above the hh if needed delete the currently displayed hour type the correct hour in its place The digits for hour can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by entered for four o clock 4 Correc
228. e eee eee 1 3 Priming sse wa cepa UE RR E Gees p eds 10 11 Text field o uio lie IL lm Re met penes 1 3 PIDE cie arson athe lose Pate Galle edu oS at Ae 2 37 Manual format 0 c eee eee eee 1 3 A utrum ie ae a tea eat nx cesi eoo Aline 4 2 Margin of reading accuracy 2 52 Printer cartridge oooooooooooooomo 10 14 Index IMMAGE 800 Operations Manual A11403 Page iv of vii March 2004 Printer power switch o ooo oooooooo o 1 10 Reagent carousel 0c eee eee eee 2 5 Printing a screen Reagent cartridges o ooo 2 5 6 14 GUIS scisco eie emite tee arated etd 2 38 Reagent compartment 2 4 5 77 Printing calibrator target values 6 37 Reagent compartment cover 2 5 Printing data from a Screen o o 2 38 Reagent crane ooccoococo ee 2 6 Printing load liSt oo ooooooooooo 7 75 Reagent paddle mixer o ooooococoooooo 2 7 Probes Oo x Sel el ee 10 10 10 58 10 70 Reagent parameters 0c eee eee eee 6 7 Probes mixers ooo 10 8 Reagent probe eee eee eee 2 7 Program batch screen bar code priority disabled 7 50 Reagent status calibration status screen 6 3 Program batch screen bar code priority enabled 7 48 Reagent syringe pump esee 2 7 Program control SCreen o ooooooooooo 7 41 Recall results screen 0 2 0 eee eee eee 8 4 Program
229. e field Enter your password in the Password field Enter the same password in the Confirm Password field To delete a user select the username number and select Delete User OR Select Cancel to return to the Password Protection Mode Screen 6 Select Exit to return to the User Defined Chemistries screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 69 Setting Up a UDR Chemistry Password Setup Procedure dud Taj lla Print Mot r o Enter a User Defined Chemistry Number Figure 5 28 User Defined Chemistries Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 70 March 2004 Setting Up a UDR Chemistry Password Setup Procedure Belete 2 Request Age POVE pos 2e Civ BSPR Chem Print x e List e a Rac k Conf i fis eS Insert Passuord E011434S EPS Figure 5 29 User Login Screen Host Off Clr UDR Chem Print CalRack Conf ig Plot F8 F9 F18 E011435S EPS Choose User Figure 5 30 UDR User Setup Password Protection Mode Screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 71 Setting Up a UDR Chemistry Password Setup Procedure Host Off Cie UDR Chem Print CaiRack Config Piot FS F9 rig E011436S EPS Insert Password Figure 5 31 Define Edit User Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 72 March 2004 Setting Up a UDR Chemistry Accessin
230. e in Standby in order to proceed with the steps below to change the unit for Excretion Rate calculations Step Action 1 From the Setup screen select lt 6 gt Calculations 2 Select lt 6 gt Excretion Rate OR Enter the number beside Excretion Rate in the Option field Select View Edit F1 4 Select the options button W beside the Unit field From the Calculation Unit screen select the number next to the desired unit OR Enter the number corresponding to the desired unit AND Press Enter 5 Select Cale Summary F1 OR Select any icon from the menu bar 6 From the Warning screen select OK to change the unit OR Select Cancel to exit without changing the unit Restoring Default Excretion Rate Calculations When the instrument status is in Standby proceed with the steps below to restore all default excretion rate calculations Step Action 1 From the Setup screen select lt 6 gt Calculations Refer to Figure 5 10 2 Select Select TUrine F2 Refer to Figure 5 12 3 Select lt Restore Default gt All the urine chemistry checkboxes will be unchecked and the timed urine calculations for those chemistries disabled Select lt OK gt to return to the Calculations Summary screen OR Select lt Cancel gt to return to the Calculations Summary screen without changing the timed urine chemistry definition System Setup Page 5 32 IMMAGE 800 Opera
231. e letter U appears on the plot at the update level A scale factor is also displayed on the plot window Refer to Figure 5 52 NOTICE After programming and saving a single point calibration request the curve fit model cannot be changed Each single point calibration can only use the model from the last approved mult point calibration If the update level letter U does not appear on the plot window the single point calibration is not reliable Repeat the single point calibration If the results are the same perform a multi point calibration 1 of 2 System Setup IMMAGE 800 Operations Manual A11403 Page 5 108 March 2004 Approving a Calibration Plotting a Robust Means Data Curve Step Action 3 To print a curve fit model plot press Ctrl P on the keyboard 4 Select Print Report F8 to print the data and statistics for a curve fit model Select UDR Main F10 to return to the User Defined Chemistries screen 6 Program controls on the UDR through Sample Programming to see if the single point calibration is acceptable Another model cannot be tested 7 When the calibration model has been approved clear the UDR calibration rack Refer to Clearing a UDR Cal Rack in this chapter 2 of 2 Plotting a Robust Means Data Curve The Robust Means Data Curve plots a Robust Means Time curve for reagent development purposes A Robust Means Data Curve may be plotted for UDR rat
232. e of auto daily monthly and as indicated maintenance to keep the IMMAGE 800 in proper operating condition For higher volume laboratories maintenance frequency when appropriate will be indicated based on the number of tests To keep a log of performed maintenance use the IMMAGE Immunochemistry Systems Maintenance Logbook Utilities IMMAGE 800 Operations Manual A11403 Page 10 6 March 2004 Auto Maintenance Procedures Auto Auto Maintenance Procedures Auto The Auto Maintenance cycle washes all cuvettes 1 39 This cycle is performed automatically when The system is in Standby and one or more of the cuvettes has not been washed in the preceding 12 hours The system is in Standby and one or more of the cuvettes has not been used in the preceding 12 hours If the system is active when one of the above situations occur or the system is interrupted during the Auto Maintenance cycle the wash will run again in one hour IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 7 Daily Maintenance Procedures Daily Daily Maintenance Procedures Daily The following table lists the scheduled daily maintenance for the IMMAGE 800 System Table 10 2 Daily Maintenance Check Clean Wash Volume and Tubings Reagent and Sample Probes Mixers Waste Volume and Tubing Fluid spills Syringes tubings tips and valves Observe and Check As part of daily maintenance perform the following s
233. e operational modes below lt I gt Single lt 2 gt Multiple OR Select lt Cancel gt to exit the Request Information Mode dialog box without selecting the request information mode Selecting Message Header Mode The message header mode determines if the message headers sent to the host will include the Sender ID Version No and Date and Time of Message fields The instrument status must be in Standby in order to proceed with the steps below to select the message header mode Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the options button lt W gt beside Message Header Mode to enter the Message Header Record Mode dialog box 3 Select the number next to one of the operational modes below lt 1 gt Full Header lt 2 gt Abbreviated Header OR Select lt Cancel gt to exit the Message Header Record Mode dialog box without selecting a message header mode IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 55 Host Communications Setup Restoring Defaults Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore the host communication parameter defaults Step Action Figure 5 21 1 From the Setup screen select lt 10 gt Host Communications Refer to 2 Select Restore Default F1 Refer to Table 5 6 Select lt OK gt to rest
234. e rack with the bar code label facing the same direction as the rack label Label Print Quality Printed by direct thermal or thermal transfer Label Symbologies Code 39 Interleaved 2 of 5 Codabar Code 128 Check Characters The use of check digits and fixed length codes is highly recommended where possible This greatly reduces the possibility of scanning errors System Description IMMAGE 800 Operations Manual A11403 Page 2 52 March 2004 Bar Code Label Specifications Label Sources Label Sources All patient and control sample labels are supplied by the customer Preprinted labels can be used or labels generated by a bar code printer Beckman Coulter Inc recommends the following printers Execuport 2400 Computer Transceiver Systems P O Box 1117 23 Carol Street Clifton NJ 07014 0996 Phone 201 473 4700 Intermec 3000A Intermec Corporation 6001 36th Avenue West Everett WA 98203 Phone 1 800 755 5505 Zebra 130 Zebra Technologies Corp 333 Corporate Woods Parkway Vernon Hills IL 60061 Phone 708 634 6700 Please contact any of the above vendors or industry standard associations for any specific bar code application issues IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 53 Applying Bar Code Labels Correct Application of Bar Codes Applying Bar Code Labels Correct Application of Bar Codes Refer to the IMMAGE Sampling Template for the correct application of bar codes
235. e screen and select samples to be rerun Refer to Rerunning a Sample Selecting Samples to be Rerun in this Section for more information 2 Select Edit Samples Perform any of the following Refer to Figure 7 20 Edit the desired sample program information Refer to Programming a Sample in this chapter for more information Select Reuse Dil F4 to reuse the original dilution Select OK to confirm e Select Clear Chems F8 to clear all original chemistry selections Then select the desired chemistry s to be rerun 4 Select Save Next F10 to edit the next sample OR return to the Sample Program screen when all samples selected for rerun are edited Beaman DD KI Ev E Main Samples Results Rats Cal gc Setup Utils Status STOP Rerun Edit Samples rio eme rack s Pos stat joe i mn es Be 2 UU NNI Sample Reuse Options Dil E3 F4 Enter Panel Number s E010304S EPS Figure 7 20 Rerun Edit Samples Screen Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 66 March 2004 Rerunning Original Sample Programs 7 Introduction Rerunning Original Sample Programs Introduction Samples can be rerun with no change to the original sample programs All initial dilutions will be remade when original sample programs are rerun The Reuse Dilution option is only available through Edit Samples Rerunning Original Programs Follow the steps belo
236. e the changes or additions OR Select Cancel to return to the Chemistry Configuration screen without saving changes or making additions Define Print Names Chen Print Nane Chen Print Name 2 IGA 3 IGM 4 C3 5 C4 5 E010215S EPS Figure 5 3 Define Print Names Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 7 Configuring the Chemistry Menu Additional Information Additional Information Refer to CHAPTER 6 Reagents Calibration Loading Unloading Reagent Cartridges for information on unloading chemistries Refer to CHAPTER 7 Sample Programming Selecting Chemistry Tests by Panel and Selecting Chemistry Tests by Chemistry for information on removing chemistries from a programmed sample Refer to CHAPTER 7 Sample Programming Programming a Control for information on removing chemistries from a programmed control System Setup IMMAGE 800 Operations Manual A11403 Page 5 8 March 2004 Panel Setup Introduction Panel Setup Introduction The IMMAGE 800 holds up to 50 chemistry panels in its memory Each panel is defined with a name and the chemistries that it contains Defining New Panels The instrument status must be in Standby in order to proceed with the steps below to define a panel list Step Action 1 From the Setup screen select 2 Panels Refer to Figure 5 4 2 Select an available panel number fo
237. eat Steps 4 5 11 Select Panels Summary F2 to return to the list of panel summaries Refer to Figure 5 4 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 11 Panel Setup Deleting Panels Deleting Panels The instrument status must be in Standby in order to proceed with the steps below to delete defined panels Step Action 1 From the Setup screen select lt 2 gt Panels A multipage list of panel summaries will be displayed 2 Select the numbers beside the panels to be deleted Select Delete Panels F2 4 Select lt OK gt at the Delete ALL selected panels dialog box OR Select lt Cancel gt to return to the list of panel summaries without deleting the panels System Setup IMMAGE 800 Operations Manual A11403 Page 5 12 March 2004 Bar Code Setup Introduction Bar Code Setup Introduction The bar code symbologies recognized by the IMMAGE 800 can be selected Additionally the bar code parameters can be configured to match those of the sample bar codes being read Enabling Disabling Bar Code Symbologies The instrument status must be in Standby in order to proceed with the steps below to enable or disable bar code symbologies Step Action 1 From the Setup screen select 3 Bar Code Refer to Figure 5 6 2 To enable a bar code symbology select the check box beside the symbology If the check box is checked the symbology is
238. ected the QC File List by Control Name is displayed with all defined controls Select QC File List F4 Refer to Figure 9 6 4 Select to display the QC list by List CtlName F1 Control name List File F2 File number List SelChem F3 Selected chemistries Choose the chemistries and select lt OK gt to display the QC List OR Select lt Cancel gt to exit without displaying the QC List List All Chem F4 Chemistry name in alphabetical order 5 Select Print F10 to print the File List Select any icon from the menu bar to exit OR Quality Control Page 9 20 IMMAGE 800 Operations Manual A11403 March 2004 Displaying the QC File List Displaying QC File Lists QC Filet 288 201 E014034S EPS Figure 9 6 QC File List IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 21 QC Log Introduction QC Log Introduction The QC Log displays results from a specified period with interpretations regarding the relationship between QC results using the assigned mean and standard deviation Data points can be deleted from the hard disk only and the cumulative statistics will update automatically The deleted data points are marked as deleted with the operator s initials and the date and time of deletion The operator may view or print the QC Log from either the hard disk or the floppy disk The Action Log within the QC Log function allows comments to be attached to specific
239. eee 2 53 Label symbologies Off line dilution 7 17 7 18 Godabare taco cise Seas we ee US 2 52 Off line dilution factor 7 28 7 33 7 34 7 70 Code Oi ari MORAN 2 52 Off line dilution ratio o oooo ooooo 7 10 Code 39 iii ria 2 52 o E 2 37 Interleaved 20f5 0 0 eee eee eee 2 52 One chemistry selecti0N oooo oooooo 9 6 Lambda LAM 0 0 cece eee eee eee 3 8 A rene on ts Sikes ele aS 2 9 10 53 10 62 Laser caution label o 1 12 Options button 00005 2 28 2 31 Leaks celeber sey da os 10 10 Out of range testing description 3 11 Light scatter signal development 3 3 Light scattering complexes sss 3 4 Link to recall demographics 7 24 P Linking samples 2 00 eee eee eee 7 35 Linked samples running lusus 7 36 Page up page down 05 2 35 2 39 Load list dialog box o oooooooooo o 7 71 Panel sample type 0 00 cee ee eae 7 20 Ed oni ceo ura a 7 72 Panels list A range of alphanumeric sample IDs 7 72 Panels dialog box 02002000e 7 17 A range of sample lDS 7 72 Password setup procedure ooo oo o ooooo o 5 69 All sample IDs 2 2000 0 eee eee 7 72 Patient demographics 7 10 7 25 Individual sample IDS 7 72 Patie
240. een Loading Reagent Calibrator Bar Coded Parameters Displaying Deleting Reagent Parameters Loading Clearing Buffers and Diluents Loading Wash Solution Loading Unloading Reagent Cartridges Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 2 March 2004 Reagent Status Calibration Status Screen Displaying the Screen Reagent Status Calibration Status Screen Displaying the Screen Select Rgts Cal from the menu bar Refer to Figure 6 1 Standby Host Off 02 09 2004 11 35 e F Ee 2 Hain Samples Results Rats Cal Reag ent Status Pos Chw Left Loi IGG 288 M309294 Z mst 10 3 funr1 s F959 123456 4438 12344BC E999 Re Reagent Buffer Request Reagent Summary Di luent Sa F1 F2 F3 ES Select an option Figure 6 1 Screen Headings Description Seria a Number Status n Qc Setup Utils Status Stop F12 About Calibration Status Cal Date 62 62 2004 Cal ID CAL 1 M382135 v k Calibrated Uncalibrated EA A Unapproved 62705 2004 Cal Cal Gance i Options LdList egusst F5 F6 d E011425S EPS Reagent Status Calibration Status Screen The following table describes the headings of the Reagent Status Calibration Status screen for Beckman Coulter chemistries Table 6 1 Screen Headings Heading Description Pos Position of the reagent cartridge on the reagent carousel Chem Name of chemistry Tests Left Number of te
241. efinitions for the same chemistry calculation Use the Page Up or Page Down buttons to move to other pages of the same chemistry calculation Select another sample type and or sex to define additional groups of the chemistry calculation Repeat Steps 1 7 OR Select Prev Chem F9 or Next Chem F10 to define other chemistries Repeat Steps 1 7 OR Select any icon from the menu bar to exit the screen Selecting the Default 2 of 2 The default interval and range will be printed when an age is not specified in sample programming or when age is specified but the reference interval has not been defined for that age Only one default can be chosen for a particular interval and range definition grouped by chemistry calculation sample type and sex When the instrument status is in Standby proceed with the steps below to select the default interval and range Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 Select the button beside the desired chemistry calculation Multiple chemistries calculations may be chosen Select lt Define Edit gt Refer to Figure 5 7 Select a field on the interval range line that is the chosen default Select Select Default F4 A gt symbol will mark the default range on the far left of the line Select another sample type and or sex to move to other definitions within the same chemistr
242. elds or functions are accessible while the status is displayed Table 7 1 Sample Status Status Description Accessible Fields Functions Not Programmed Sample is not programmed or All saved Sample Required Sample program is saved All Waiting to Run The sample carousel was Demographics scanned and the sample program is recognized by the system Add chemistries and any options related to them Running One or more tests requested for the sample are running Sample Comment Demographics Add chemistries and any options related to them 1 of 2 IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 11 Program Sample Screen Program Sample Working Area Table 7 1 Sample Status continued Status Description Accessible Fields Functions Complete All tests requested for the Demographics sample are completed Rerun Incomplete At least one test result for the Patient ID sample is pending Sample Comment Demographics Rerun Program Sample Working Area 2 of 2 The Program Sample screen working area is divided into three sections The following table lists the functions available in each section of the working area Table 7 2 Working Area Functions Section Functions Upper Allows entry of the following information associated with a sample Rack STAT Designation Sample Comment Position Sample Type Sample ID Patient ID Patie
243. emented by one position After a blank position is inserted a chemistry can be defined for that position using the normal procedure Refer to Defining a Chemistry for a Position in this section The instrument status must be in Standby in order to proceed with the steps below to insert a blank position Step Action 1 From the Setup screen select lt 1 gt Chemistry Configuration 2 Select a position 3 Select Insert Chem F5 to insert a blank position and increment the subsequent chemistries by one position 4 Define a chemistry for the new blank position as described in Defining a Chemistry for a Position in this section IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 5 Configuring the Chemistry Menu Deleting a Chemistry Deleting a Chemistry This function deletes a chemistry from the menu and decrements the subsequent chemistries by one position The chemistry protocol remains in the system When the chemistry is deleted from the chemistry menu the system automatically removes the chemistry from any configured control e the system automatically removes the chemistry from any configured panel in which it is defined accumulated QC data for the chemistry is not deleted Step Action 1 From the Setup screen select 1 Chemistry Configuration 2 Choose a position for the chemistry to be deleted 3 Select Delete Chem F6 4 Select OK to del
244. emistry cannot be canceled after the run is started Additional Information Refer to CHAPTER 5 System Setup Configuring the Chemistry Menu for more information on configuring the chemistry menu IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 19 Selecting a Sample Type Introduction Selecting a Sample Type Introduction Sample Type is selected from a list which contains e Serum e CSF Plasma Random Urine Timed Urine The default Sample Type is defined in Setup and is initially displayed in the Sample Type field NOTICE If a sample type is selected that is not applicable to specific chemistries those chemistries are unavailable and appear dimmed on the chemistry menu Selecting a Sample Type Follow the steps below to select a Sample Type Step Action 1 Select Samples from the menu bar 2 Select the options button lt W gt beside the Sample Type field 3 Type the number of the desired Sample Type and press Enter OR Select the number beside the desired Sample Type Panel or Control Sample Type If a panel or control is selected the Sample Type defined for the panel or control will automatically appear Sample Programming Page 7 20 IMMAGE 800 Operations Manual A11403 March 2004 Selecting a Sample Type Timed Urine Parameters Timed Urine Parameters If Timed Urine is selected as the Sample Type a dialog box
245. ep Action 1 From the Setup screen select lt 13 gt Demographics Setup 2 Select Restore Default F1 The default is all fields accessible 3 Select lt OK gt to restore defaults OR Select lt Cancel gt to return to the Demographics Setup screen without restoring the defaults IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 63 Printer Setup Introduction Printer Setup Introduction The printer type is a Hewlett Packard Deskjet or compatible The paper size can be selected Selecting Paper Size The instrument status must be in Standby in order to proceed with the steps below to select the paper size Step Action 1 From the Setup screen select lt 14 gt Printer Setup Refer to Figure 5 25 2 Select the options button lt W gt beside Paper Size 3 Select the option number for the desired paper size OR Select lt Cancel gt to return to the Printer Setup dialog box 4 Select lt OK gt OR Select lt Cancel gt to return to the Printer Setup dialog box without changing the paper size Default is U S Domestic 8 Y x 11 inches Printer Setup Printer Type HP 666 or Compatible Paper Size U S Domestic 8 1 2 x 11 m 7l Restore OK Cancel Default E010231S EPS Figure 5 25 Printer Setup Dialog Box Restoring Default To restore the paper size default select Restore Default from the Printer Setup dialog bo
246. eport header E014090S EPS Figure 5 9 Report Setup Screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 25 Report Setup Defining the Patient Report Format Defining the Patient Report Format The instrument status must be in Standby in order to proceed with the steps below to define the patient report format Step Action 1 From the Setup screen select lt 5 gt Report Setup Refer to Figure 5 9 2 3 Select the options button lt W gt beside Patient under Report Format Select the number for the appropriate format Refer to APPENDIX C Reports for format examples Lab Report Lab Report Dilutions Patient Chartable Reports The default patient report format is Lab Report Disabling Automatic Printing Patient calibration and control reports automatically print unless the print is disabled The instrument status must be in Standby in order to proceed with the steps below to disable automatic printing Step Action 1 From the Setup screen select lt 5 gt Report Setup Refer to Figure 5 9 2 Select the check box next to Patient Report Calibration Report Control Report to disable the automatic printing of patient calibration or control reports respectively The default is all three reports are automatically printed checked System Setup Page 5 26 IMMAGE 800 Operations Manual A11403 March 2004 Report Setu
247. equest F7 Cancels a calibration after it has been requested Read Cards FS Reads reagent or calibrator bar code cards when cards are placed on the sample carousel racks Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 4 March 2004 Loading Reagent Calibrator Bar Coded Parameters Introduction Loading Reagent Calibrator Bar Coded Parameters Introduction A reagent bar code card is provided with every reagent kit The reagent bar code card contains lot specific parameters for each reagent A calibrator bar code card is provided with every calibrator The calibrator bar code card contains lot specific parameters for each calibrator When to Load Prior to reagent calibration the reagent and calibrator bar code cards must be scanned into the database If a reagent or calibrator lot was previously used the bar code card does not need to be rescanned Limits Up to 8 reagent or calibrator bar code cards can be loaded on the sample carousel at one time Upto 6 different lots of the same reagent or calibrator ID can be stored at one time When more than 6 different lots are scanned the oldest by date of scan is removed from the database Up to 50 different calibrator names can be stored in the database Loading Bar Code Cards The instrument status must be in Standby in order to proceed with the steps below to load reagent and calibrator bar code cards Step Action 1 Place the reagent or cali
248. er vendor information or other comments This field is limited to 20 alphanumeric characters 2 of 2 Defining an AGXS Limit The AGXS Limit is a user defined value The AGXS Limit feature will only be available if the UDR has a status of calibrated and uses a Non Competitive Nephelometric or Non Competitive NIPIA protocol Entry of this value in the AGXS Limit field is only available after a UDR multi point calibration has been performed and approved Entering an AGXS Limit value into the UDR definition will clear the calibration program of the defined UDR The AGXS limit is calibration specific therefore recalibrating a UDR using a multi point calibration will clear the AGXS Limit field and disable AGXS flagging During the sample run if the calibrated rate for a UDR sample reaction is equal to or greater than the value entered for the AGXS Limit in the UDR definition the system will suppress the results and display in the results column on the results display and printout instead of a numerical result AGXS flagging shall not apply during UDR Rate Mode runs System Setup IMMAGE 800 Operations Manual A11403 Page 5 80 March 2004 Defining a UDR Chemistry Defining UDR Sample Reagent Volumes Refer to follow the steps to enter an AGXS flagging rate value Step Action 1 From the User Defined Chemistries screen select the chemistry for AGXS flagging Refer to Figure 5 28 Select Define Edit
249. erial and or Refill numbers does not affect calibration Editing anything else clears the calibration programs cancels the calibration clears the AGXS Limit and disables AGXS flagging If the serial number is changed in the protocol definition the cartridge identified by the overwritten serial number is no longer usable regardless of the number of tests remaining Editing a UDR Definition is summarized in Table 5 12 below Table 5 12 Editing a UDR Definition Edited UDR Definition Effect on Calibration Effect on AGXS Flagging Comments No Effect No Effect Serial Number Status Calibrated Refill Cartridge Sample Dilution Clears Program No Effect AGXS Limit Status Calibrated All Other Parameters Clears Program Cancels Calibration Clears AGXS Limit Status Uncalibrated Disable Flagging IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 87 Loading UDR Reagent Cartridges Introduction Loading UDR Reagent Cartridges Introduction The UDR reagent cartridges must be loaded before performing a run Description of Cartridge The UDR cartridge provided by Beckman Coulter contains the following information Limits Cartridge lot number Cartridge serial number Six UDR cartridges may be loaded on the reagent carousel at one time Each UDR cartridge has a set number of 300 tests When the 300 tests count down to zero a new UDR serial number and or cartridge lot numbe
250. escription Page 2 29 Text Fields Definition of Text Field Text Fields Definition of Text Field Text fields are white areas on the screen in which the user types data Definition of Cursor When a text field is chosen a cursor displays in that field This cursor indicates where text will be entered Characteristics of Text Fields Unless otherwise noted most text fields can accept any alphanumeric characters This means that the user can type in any letter number or a space Each text field has a limited number of characters that can be entered Most text fields have a restricted set of characters that can be entered Example If the user attempts to enter anything other than a number in a numeric field the character will not be entered A message will display which reads Only numeric characters are allowed NOTICE The alphanumeric characters I piping bar backslash caret and amp ampersand are not allowed because they are host interface delimiters System Description IMMAGE 800 Operations Manual A11403 Page 2 30 March 2004 Buttons Function Buttons Function Buttons on the screen perform as their name implies When they are selected or pressed an action is performed in the software Often this action will be used to access a new screen or dialog box The icons in the menu bar and the function buttons on the bottom of the screen operate like buttons Example The opt
251. ese and English characters These include but are not limited to Post Run Summary Sample Load List Results Recall Calibration Reports and Load Lists Sample Programming Page 7 94 IMMAGE 800 Operations Manual A11403 March 2004 Display Language 7 Data Storage Retrieval Data Storage Retrieval The IMMAGE 800 system has the capability of retrieving samples and results by patient names in Japanese Data entered in Japanese is stored and retrieved in the Japanese language mode Databases stored archived in Japanese are not displayable with Japanese characters in other languages Databases stored archived in other languages are retrievable in the Japanese language mode but not translated Kanji characters from the main Kanji dictionary are retrieved automatically as needed IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 95 Host Communication Interface Japanese Character Transfer Host Communication Interface Japanese Character Transfer Special provisions are necessary to accommodate the transfer of Japanese characters over the customer communication network The baseline IMMAGE 800 host communication protocol uses the specifications of ASTM E1381 91 The optimal use of escape delimiters is implemented to allow sending and receiving of Japanese characters For further information refer to IMMAGE Immunochemistry Systems Host Interface Specifications Revision AD or greater
252. esired Use the lt Page Up gt lt Page Down gt buttons to access additional controls 2 Select QC Log F5 3 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select lt OK gt to choose the default Use Tab to toggle between fields Select lt OK gt to continue OR Select lt Cancel gt to exit 4 Select the result by selecting the check box next to the result Select Action Log F4 6 The QC Action Log dialog box appears Enter a maximum of 30 alphanumeric characters in the Comment field Select lt OK gt to save the comment in the database OR Select lt Cancel gt to exit without saving the comment 1 of 2 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 25 QC Log Action Log Step Action continued Select Print F10 to print the QC Log 2 of 2 Quality Control Page 9 26 IMMAGE 800 Operations Manual A11403 March 2004 Displaying QC Summaries Introduction Displaying QC Summaries Introduction The QC Summary report contains the cumulative mean SD CV and number of results N for any control within a specified date interval The printed report contains the cumulative mean SD CV and Number of accumulated results A report can be printed in the Inter Lab format for submission to Beckman Coulter The constituent code must be defined in order for a chemistry
253. estore Default F1 Date Time Restore Default F1 Change Date F2 Change Time F3 Host Communications Restore Default F1 Default Setup Sample Comments Demographics Setup Restore Default F1 Printer Setup Languages Keyboard Chemistry Protocol Diskette Instrument Serial Number Figure 2 23 IMMAGE 800 Program Tree 4 of 5 IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 43 Program Structure Introduction Utils Prime Utilities Event Log Display Events F1 Copy to Disk F2 Date Time F3 Clear Events F4 Print F10 Diagnostics Cycle Count Call Diagnostics Alignment Prev Align F1 Previous Alignment Format QNX Diskettes Backup Restore Wash Cuvettes Fill Internal Wash Bottle Stop Print Reload DAS Code Calibrate Touch Screen Shutdown Status Dilution Segments Sample Carousel Status Figure 2 24 IMMAGE 800 Program Tree 5 of 5 System Description IMMAGE 800 Operations Manual A11403 Page 2 44 March 2004 Sample Programming Overview Introduction Sample Programming Overview Introduction This section summarizes the sample programming methods for the IMMAGE 800 Immunochemistry System Sample Programming Options The following table will summarize the sample programming options based on the variables of bar coded samples and host interface For detailed expla
254. estoring the defaults Additional Information CHAPTER 7 Sample Programming Selecting Save Next Programming a Batch of Samples Identifying a Batch System Setup Page 5 16 IMMAGE 800 Operations Manual A11403 March 2004 Reference Interval Setup Introduction Reference Interval Setup Introduction When a reference interval and critical range are defined they are printed beside the result on the report A result outside of the reference interval or critical range is flagged The interval and range are defined per chemistry or calculation with distinction made for sample type sex and age group Chemistries must be configured and calculations must be enabled before intervals can be defined The minimum entries necessary to save a reference interval are low age low age unit high age high age unit low reference interval number and high reference interval number Defining Editing Sample Type and Sex The instrument status must be in Standby in order to proceed with the steps below to define a sample type and sex for intervals and ranges Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation being defined Multiple chemistries calculations can be chosen Select lt Define Edit gt Refer to Figure 5 8 Select the options button lt W gt below Sample Type Select the sample type The de
255. ete the chemistry OR Select Cancel to return to the Chemistry Configuration screen without deleting chemistry NOTICE If the error message Unable to delete chemistry is displayed one of the following conditions exists The reagent is on board the instrument The chemistry is programmed for a sample The chemistry is configured in a programmed control This condition must be corrected before the chemistry can be deleted System Setup Page 5 6 IMMAGE 800 Operations Manual A11403 March 2004 Configuring the Chemistry Menu Defining Print Names Defining Print Names This function allows definition of print names for each chemistry A Print Name is any defined text that will print on the patient chartable report in place of the Beckman Coulter chemistry name The instrument status must be in Standby in order to proceed with the steps below to define a Print Name Step Action 1 From the Setup screen select 1 Chemistry Configuration 2 Select Define PrtName F3 Refer to Figure 5 3 The chemistry menu will be displayed If there are chemistries defined for positions greater than 20 the Page Up and Page Down buttons can be used to show additional pages of chemistries Choose the text field beside the desired chemistry Type the print name up to 21 alphanumeric characters For additional chemistries repeat Steps 3 4 DN ny AJ Ww Select lt OK gt to sav
256. etup ii din E dE UVRE LOI EY RE SR Re Vo 5 50 Default SOUP sacssctie stn a cetus iie Lodel o sd 5 57 sample Comments Sepp usce Sea seared cay oes le buen fest messes UG CUN ERU dy base oe MIRIAM e esos 5 60 Demographics CU te o tosb endet het ton ee Beatum teo iae 5 62 Printer Selllpuocasdie uet iN SAMO RNO UIS EBORE A M ADMI LM pe MSAN ME AIMER IN I 5 64 Language SUP hurts tao ee veta VU sd ev UI EVA TA We C EDIn Dac uen a eM Rouen Dune aM Rad 5 65 Loading the Chemistry Protocol Diskette oooconncccnincccnnncccnonccconancnoncnonnnnnonnnnccnoncnonncnonnnnnos 5 66 Instrument Serial Number Set p iei eite eias ee aei ona eret pe ae REPE Ee E feda toas dee 5 67 User Defined Reagent Chemistry Sebup a soper ates ed a e td be tius 5 68 UDR Chemistry Overview and Precautions essen enne enne ennt 5 68 beiung Dpa UDR Chemisty caeai RO nde mua ee Ads 5 60 Defining a UDR ChH mistiy sareni Ne ERO eset sn esate sare etie uf as aun han dol DU ARN 5 75 Defining UDR Calibration Information essere enne rennen enne 5 84 Deleting UDR Cheitilst les 41 5 o nya eren SOR E Aa P Aerea Fel DRE uS 5 85 Edite UDR D finitions cate 5 86 Loading UDR Reap ent C arid si 5 88 Loading Clearing UDR Buffer and Diluent di 5 91 Programming Rate MOode usum terenne eas 5 93 Calibrating a UDR Chemistry ossi dues edge te tns ud rd cite dud ds ld es Da 5 96 Approving Calibration sinoti estet e NRR eS INNER eS URRR NNUR n Se TNR Ue dae
257. f 02 06 2004 14 17 Status Stop F12 INFORMATIONAL OK to load samples Select an option E011430S EPS 4 Figure 7 18 OK to Load Samples Message Canceling a Pause Select the lt Cancel gt button to cancel the pause request This will not affect the current run Refer to Figure 7 17 IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 59 Pausing to Load Samples Resume Operations Resume Operations If the user chooses to resume operations before the system goes to Standby the system continues the pause process until all currently running tests are complete When all operations are complete the system reinventories the sample wheel and automatically returns to the running state If the user resumes operations after the system goes to Standby the system reinventories the sample wheel and returns to a running state Incomplete samples requiring additional dilutions continue processing at the next required sample dilution Dilutions created before selecting Pause will not be reused In some instances the system may have to remake previously made dilutions and additional sample volume may be required Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 60 March 2004 mud 7 Rerunning a Sample Overview Introduction A sample can be rerun when it has a status of Complete or Incomplete If the system is running a sample programmed to be rerun will be added to the current run
258. f the Bar Code Priority is batch programming will disabled autonumber the racks and positions enabled not autonumber the racks and positions The instrument reads bar coded samples whether or not the Bar Code Priority is enabled Disabling the Bar Code Priority is recommended Enabling Disabling Bar Code Priority The instrument status must be in Standby in order to proceed with the steps below to enable or disable Bar Code Priority Step Action 1 From the Setup screen select lt 3 gt Bar Code 2 To enable bar code priority select the check box beside Bar Code Priority If the check box is checked the bar code priority is enabled 3 To disable bar code priority deselect the check box beside Bar Code Priority If the check box is unchecked bar code priority is disabled The default is bar code priority enabled IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 15 Bar Code Setup Restoring Defaults Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore bar code symbology defaults Step Action 1 From the Setup screen select lt 3 gt Bar Code 2 Select Restore Default F1 to return all bar code setups to their defaults 3 Select lt OK gt at the confirmation screen to restore the defaults OR Select lt Cancel gt to return to the Bar Code Setup screen without r
259. f three locations the Quality Control screen the Review Controls screen the Define Edit Controls screen The entire control definition all chemistries is deleted Deleting from the Quality Control Screen Follow the steps below to delete a control definition from the Quality Control screen Step Action 1 Select QC from the menu bar 2 From the Quality Control screen select the button beside the Control Name to be deleted Select Delete Control F3 4 Select OK to delete the control OR Select Cancel to return to the Quality Control screen without deleting the control 5 Enter a maximum of 3 alphanumeric characters in the Operator ID field Press Enter Deleting from the Review Control Screen Follow the steps below to delete a control from the Review Controls screen Step Action 1 Select QC from the menu bar 2 From the Quality Control screen select the button beside the Control Name to be deleted Select Review Control F1 4 Select Delete Control F3 Select lt OK gt to delete the control OR Select Cancel to return to the Quality Control screen without deleting the control of 2 Quality Control IMMAGE 800 Operations Manual A11403 Page 9 18 March 2004 Deleting a Control Definition Deleting from the Define Edit Controls Screen Step Action continued 6 Enter a maximum of three alphanumeric characters in t
260. fault is serum Select the options button lt W gt below Sex Select the sex The default is M F Male Female coo y OQ NY AJ O Go to Defining Editing Intervals and Ranges IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 17 Reference Interval Setup Choices for Age Field Entries Reference Interval Critical Ranges Configured Chemistries Def ine Clear Print Edit Ranges ic Cancel em the chemistries E010308S EPS Figure 5 7 Reference Interval Critical Ranges Dialog Box y IS z 4 E E i g A n 5 2 DON aa A Insert Delete Clear Select Line Line nges Default Fi F2 F3 F4 Enter low age range E010309S EPS Figure 5 8 Reference Interval Critical Ranges Screen Choices for Age Field Entries The following choices are available for the age field entries Table 5 2 Age Field Entries Field Entry choices Low Age Range High Age Range 0 999 Age unit field next to the low and high age fields Y Years default H Hours D Days W Weeks M Months System Setup IMMAGE 800 Operations Manual A11403 Page 5 18 March 2004 Reference Interval Setup Before Defining Editing Intervals Ranges Before Defining Editing Intervals Ranges If more than one age defined interval or range is to be entered it must be entered from the lowest age range to the highest age range Exampl
261. fficient Bottle Fill CALL BECKMAN COULTER Procedure has CLINICAL SUPPORT Timed Out LLS 1 1615 Cannot Start Run WARNING Verify that volume in external wash Internal Wash solution container is sufficient Bottle Fill CALL BECKMAN COULTER Procedure has CLINICAL SUPPORT Timed Out LLS2 1616 Cannot Start Run WARNING Verify that reaction module cover is Reaction properly seated Temperature is CALL BECKMAN COULTER out of Range CLINICAL SUPPORT 1617 Cannot Start Run WARNING Verify that volume in external wash Internal Wash solution container is sufficient Bottle is Empty CALL BECKMAN COULTER CLINICAL SUPPORT 13 of 21 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 35 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 1620 Mechanical WARNING Reagent or 1 Check that the reagent cover is on Devices are reaction cover may have the instrument inoperable Go been opened during 2 Close reagent cover if open to Diagnostics or power on 3 Select Utils Alignment to 4 Select Diagnostics correct the 5 Select Main problem 6 Select lt OK gt to exit the Diagnostics message 7 Observe that the probes home 8 Select Home 9 If the probes home then proceed to the next step If the WARNING is displayed again CALL BECKMAN COULTER CLINICAL SUPPORT 10 Wash t
262. first 5 minutes of operation to respond to any messages that might be displayed IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 55 Overview Introduction Pausing a Run Overview Introduction When the system is running the user may select the pause option to load samples without waiting for the entire system to complete all actions When pausing a run The user can pause the system for a sample load The user can pause the system completely The user can cancel the pause request Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 56 March 2004 System Pause 7 Introduction System Pause Introduction If the system is running and the user selects the pause option from the IMMAGE 800 main screen the user may choose to completely pause the system When the user selects pause the system completes any sample that is in process and goes into Standby after the pause Step 1 Action During the run select Pause at the main screen Select System Pause at the Request Pause screen Refer to Figure 7 17 The system status changes to Pausing The system completes any sample that is in process then goes into Standby mode Host Off 02 06 2004 14 11 AIR migisiE n Samples Results Rats Cal Qc Setup Utils Status Stop F12 About Option No fa di System Pause e Load Sanples Request Pause Cancel Enter an option numbe
263. form tests using the default dilution and out of range dilutions as required The user would then need to manually multiply all test results for the sample by the user prepared dilution factor IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 33 Entering an Off line Dilution Factor Entering Off line Dilution Factor Entering Off line Dilution Factor Follow the steps below to enter an Off line Dilution Factor Step Action 1 Select Sample Options F3 from the Program Sample screen 2 Choose the Off line Dilution Factor field 3 Enter the factor by typing the number of total parts of diluent sample 1 01 9999 99 and press Enter AN CAUTION If a non standard or off line dilution is selected a condition of antigen excess could exist which may not be detected by the IMMAGE 800 System When an off line dilution is selected diluent incompatibility is not detected by the IMMAGE 800 System Only chemistries using the same diluent type should be run on a sample with an off line dilution preparation Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix F System Reagent Configuration and Part Numbers for a list of chemistries using the same diluent type Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 34 March 2004 Linking Unlinking Samples 7 Introduction Linking Unlinking Samples Introduction Some special calculati
264. formation on defining controls Sample Programming Page 7 42 IMMAGE 800 Operations Manual A11403 March 2004 Programming a STAT Programming a STAT Introduction Introduction 7 A sample which requires priority can be programmed as a STAT The running priority for samples is dj STAT calibration STAT samples controls Routine calibration Routine samples controls A STAT sample is run before any routine patient or control sample on the carousel regardless of the Rack and Position numbers A STAT calibration is run before a STAT sample A STAT calibration must be programmed when the calibration is requested If multiple STAT samples are programmed they will be run in the order they are placed around the sample carousel in a counter clockwise direction Programming a STAT Sample Follow the steps below to program a STAT sample Step Action 1 Select Samples from the menu bar 2 Select the STAT check box This can be done at any time while programming a sample Additional Information Refer to CHAPTER 6 Reagents Calibration Requesting and Canceling Calibration for more information on programming a STAT calibration IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 43 Selecting Save Next Introduction Selecting Save Next Introduction When all desired information is programmed for a sample select Save Next F10 to program add
265. from the Program Sample screen 2 To enter type individual Sample IDs the Sample IDs desired for the Load List in the Sample ID s field up to 43 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric the individual Sample IDs to be requested Sample IDs in the Sample IDs field separated by a comma all Sample IDs 0 in the Range field Press Enter Type Zzzzzzzzzzzzzzz in the Thru field 3 Select a button from the bottom of the dialog box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 72 March 2004 Requesting Load List by Rack and Position Requesting a Load List Requesting Load List by Rack and Position Follow the steps below to request a Load List by Rack and Position Step 1 Select Load List F9 from the Program Sample screen Action 2 Type the rack number s desired for the Load List in the Rack s field up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 If one rack number is entered then Press Enter to access the Pos s field Type the position numbers desired for the Load List up to 15 alphanumeric characters
266. g Enable Disable the Antigen Excess testing E010223S EPS Figure 5 17 Antigen Excess Screen System Setup Page 5 42 IMMAGE 800 Operations Manual A11403 March 2004 Configuring Antigen Excess Testing Restoring Defaults Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore the default Step Action 1 From the Setup screen select lt 8 gt Antigen Excess 2 Pressing Restore Default F1 will set AGXS testing to enabled for all appropriate chemistries requiring AGXS testing IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 43 Date and Time Setup Introduction Date and Time Setup Introduction At installation the system requires the date and time to be set After this changing the date or time is optional The format of the date and time for the appropriate screens and printouts may be changed as well Formatting the Date The instrument status must be in Standby in order to proceed with the steps below to format date parameters Step Action 1 From the Setup screen select lt 9 gt Date Time Refer to Figure 5 18 2 Format the order of the date by selecting the button beside Order Select either 1 Month Day Year 2 Day Month Year 3 Year Month Day Format the day by selecting the button beside Day Format Select either 1 Leading Zero 01 2 No Leadin
267. g calibrators into the same sample rack Open the sample compartment cover 8 Place the rack s containing calibrators on the sample carousel Rotate the sample carousel by pressing the advance button on the instrument NOTICE Place racks containing calibrators in position A and B Controls and or patient samples may be placed in other positions on the sample carousel Refer to CHAPTER 7 Sample Programming 9 Close the sample compartment cover Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 30 March 2004 Loading Calibrators on the Sample Carousel Displaying Printing Cal Load List Displaying Printing Cal Load List After the calibrators are manually assigned follow the steps below to display or print the Calibrator Load List and to load calibrators Step Action 1 From the Reagent Status Calibration Status screen select Cal LdList F6 Refer to Figure 6 12 Select lt Print gt to print a Cal Load List OR Select lt OK gt to return to the Reagent Status Calibration Status screen Refer to APPENDIX C Reports for an example printout Placing Non bar Coded Calibrators on the Carousel Follow the steps below to place non bar coded calibrators on the sample carousel Step Action 1 According to the Cal Load List place a test tube into the appropriate rack and position 2 Place the appropriate sample cup in the te
268. g Define Edit Accessing Define Edit The instrument status must be in Standby in order to proceed with the steps below to access the Define Edit screen Step Action 1 From the Setup screen select lt 18 gt User Defined Chemistries 2 Select the UDR Option Number Refer to Figure 5 28 3 Select Define Edit F1 Refer to Figure 5 32 and Figure 5 33 Continue to Beginning a New UDR Protocol Definition in this chapter Standby Host Off Define Edit User Defined Chemistr Units Conversion Factor Chem Name mg dL Ta 1 oggaggaogag Reagent Lot 1234ABC Protocol Non Competitive Neph 2i Number Cartridge Lot M384382 Reagent 82 85 2005 Number ll Expiration Date Cartridge Serial F E999 ORDRE Tests per cartridge 5 AGXS Limit AGXS Enabled O Comments Enter a reagent lot number E011418S EPS Figure 5 32 Define Edit User Defined Chemistry Screen Page 1 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 73 Setting Up a UDR Chemistry Accessing Define Edit Off emm E gs nu ples Besults a Its Cal Qc Setup tils Status Stop F12 About Define Edit User Defined Chemistry Sample or Dilution Volume pecan Buffer i 1 Gain 3 Cal Dilution Sample Dilution Reaction Time 2s A minutes i a a Select the buffer type Figure 5 33 Define Edit User Defined Chemistry Screen Page 2 System Setup IMMAGE 800 Operations Manual A11403
269. g Zero 1 Format the month by selecting the button beside Month Format Select one 1 Leading Zero 01 2 No Leading Zero 1 3 Abbreviated Month Jan 4 Full Month January Format the year by selecting the button beside Year Format Select either 1 2 Digits lt 2 gt 4 Digits 1 of 2 System Setup Page 5 44 IMMAGE 800 Operations Manual A11403 March 2004 Date and Time Setup Formatting the Date Step Action continued 6 Determine the appropriate date separator then delete the current separator in the Separator field type in the appropriate separator any non alphabetic character Example 2 of 2 66 27 1996 89 16 AE Main Samples Results Rats Cal c Setup Utils Status STOP Date and Time gi ue Order Date Display Format _ Time Display Format De 3 Bes mme 7 xe Leading Zero vn 24 Hour z Poran i i Forast Leading Zero Perea Leading Zero A ia Separator Separator f Change the date the time or the formats defined E010224S EPS Figure 5 18 Date and Time Screen IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 45 Date and Time Setup Formatting the Time Formatting the Time The instrument status must be in Standby in order to proceed with the steps below to format the time Action 1 From the Setup screen select 9 Date Time Refer to Figure 5 18 Select either 1
270. g a Non Standard Dilution Step Action 1 From the Setup screen select lt 7 gt Units Non Standard Dilutions Refer to Figure 5 13 Select the sample type Then select the options button lt gt beside the desired chemistry Standard and non standard dilutions are displayed Refer to Figure 5 16 Select the number beside the desired dilution for the selected chemistry and sample type Note that the current default dilution is highlighted If the chosen dilution is a non standard dilution that dilution will appear on the Units Non Standard Dilutions screen OR Select lt Cancel gt to return to the Units Non Standard Dilutions screen without changing the non standard dilution OR Select lt Default gt to return to the standard default dilution Repeat Steps 2 3 for additional chemistries When a non standard dilution has been selected for a chemistry and sample type whenever this chemistry is run in this sample type the system uses the selected non standard default dilution as the initial dilution If the test is out of range at this dilution the system will step up or step down to a different dilution If the original sample was programmed to run with a standard dilution and later you changed the default dilution to a non standard dilution the sample will be rerun with the standard dilution System Setup Page 5 40 IMMAGE 800 Operations Manual A11403 March 2004 Selecting Non Sta
271. g the key that corresponds to the underlined letter in the title of that icon For example to show the Main screen press the key combination Alt m Buttons in dialog boxes may be selected using the Alt key method as well Function Buttons Functions buttons on the bottom of the screen can be selected by pressing the function keys at the top of the keyboard F1 F2 F3 The function buttons on the screen are numbered from left to right just as they are on the keyboard System Description IMMAGE 800 Operations Manual A11403 Page 2 34 March 2004 Performing Software Functions Tab Spacebar Tab Spacebar The items in the working area of the screen can be chosen by using the Tab key Pressing the Tab key moves the highlight forward generally left to right and top to bottom through the various text fields and screen buttons that may be chosen If the item is a text field data may be entered as soon as the item is chosen If the item is a button the button can be selected by pressing the Spacebar Arrow Keys Spacebar The Arrow Keys on the keyboard may also be used to move the highlight between the various items on the screen that may be chosen The highlight moves in the direction of the arrow If a text field is chosen lt and gt will move through each letter in the field before moving to the next item If the item is a text field data may be entered as soon as the item is chosen If the item is a
272. gnostics Sample Stir Motor and Reagent Stir Motor in this chapter Utilities Page 10 72 IMMAGE 800 Operations Manual A11403 March 2004 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe The instrument status must be in Standby in order to proceed with the steps below to replace the Sample Probe or the Reagent Probe Step Action 1 Disable all Electro mechanical motions Refer to Troubleshooting Callable Diagnostics Home All and Disable All in this chapter 2 Remove the left access cover 1 of the Crane Assembly by removing the two Phillips screws on the left side Loosen the Phillips screws on the right side 2 of the assembly Refer to Figure 10 36 A014076P EPS Figure 10 36 1 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 73 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Step Action continued 3 With the probe over the wash station 1 remove the tubing from the top of the probe assembly by unscrewing the black fitting 2 Refer to Figure 10 37 Figure 10 37 Locate the access cover 1 for the probe level sense cable 2 by tracing the cable from the probe Remove the access cover using a Phillips screwdriver Refer to Figure 10 38 Figure 10 38 2 of 6 Utilitie
273. h Station 2 Reaction Wheel 6 Heat Block Temperature Sensor 3 Cuvette 7 Status Monitor Temperature Sensor 4 Reference Cuvette Figure 2 5 Reaction Module System Description IMMAGE 800 Operations Manual A11403 Page 2 8 March 2004 Component List Reaction Module Component List The following table lists each component of the reaction module with its function Table 2 3 Reaction Module Components Number Component Function 1 Optics Measures light scatter in nephelometric reactions 670 nm wavelength and turbidimetric reactions 940 nm wavelength 2 Reaction Wheel Holds 39 reaction cuvettes and the reference cuvette Spins to move individual cuvettes to correct positions for each stage of the analysis 3 Cuvettes Hold the combined reactants The reaction being measured takes place in the clear plastic cuvettes The optics pass light through the cuvette to measure scatter 4 Reference Cuvette Has a known scatter value The instrument measures the scatter from the on board reference cuvette It then adjusts the optics based on these measurements and the known reference values 5 Cuvette Wash Station Washes the cuvette after the reaction is complete 6 Heat Block Controls 37 C in reaction module Temperature Sensor 7 Status Monitor Monitors reaction module temperature Temperature Sensor IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 9 Sample C
274. he Operator ID field Press Enter 2 of 2 Deleting from the Define Edit Controls Screen Follow the steps below to delete a control from the Define Edit Controls screen Step Action 1 Select QC from the menu bar 2 From the Quality Control screen select the button beside the Control Name to be deleted Select Define Edit F2 4 Select Delete Control F3 Select lt OK gt to delete the control OR Select lt Cancel gt to return to the Quality Control screen without deleting the control 6 Enter a maximum of three alphanumeric characters in the Operator ID field Press Enter IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 19 Displaying the QC File List Introduction Displaying the QC File List Introduction The operator can display and or print a list of QC files by control name chemistry name or QC File number A QC Hile is a grouping of control information for a particular chemistry in a particular control e g control lot number mean SD cumulative sums A QC File number is the unique number assigned by the operator to identify a particular QC File Refer to Defining a Control in this chapter Displaying QC File Lists Follow the steps below to list QC files Step Action 1 Select QC from the menu bar 2 Select a number beside a defined control If a Control Name is not sel
275. he cuvettes twice 1626 CAU Optics Post WARNING Repeat all chemistries run on the NIA Run Check Optics Failed NIA Channel 1626 CAU Optics Post WARNING Repeat all chemistries run on the Run Check LPIA Optics Failed LPIA Channel 1627 Cannot Start WARNING Reboot the instrument Run Alignment Checksum 1628 Cannot Start WARNING CALL BECKMAN COULTER Run UDS File CLINICAL SUPPORT Not Loaded 1629 File Gets Error WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 1630 Download Error WARNING CALL BECKMAN COULTER UDS File CLINICAL SUPPORT Exceeded Limit of 1024 Lines 14 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 36 March 2004 Table 10 7 Errors Error Table Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 1800 Fatal Results WARNING Will STOP Record what is displayed on pop up Calculation Task Run screen Error CALL BECKMAN COULTER CLINICAL SUPPORT 1801 Calibration WARNING Repeat calibration Failed for Reagent 200 Unrecognized WARNING Will STOP Verify that buffer and diluent positions Bulk Name Run are defined correctly 2002 Sizeof memory FATAL Check Sample Type for programmed allocation chemistries mismatch No Chemistry Protocol Available for this dilution 2003 Buffer Detected WARNING Define buffer positions for all loaded but Not Defined buffers 2004 Buffer
276. he rate of scatter intensity is calculated from the resulting curve 6 The rate is directly related to the concentration 7 A concentration test result is calculated based on the calibration factor the rate and any dilution factors used 8 Results may be scaled into alternative reporting units defined by the user System Description Page 2 58 IMMAGE 800 Operations Manual A11403 March 2004 CHAPTER 3 Theory of Operations Table of Contents B ros qe RO Haro RR TTE EE 3 2 Primceiples or Metliodologies sd 3 2 Signal Measurement and Reaction Dynamics esee rennen 3 3 Antigen Excess Testing rronin aao oaa Ea is 3 8 Out ofsrange VOS A EA 3 11 CAMDEN Me EET 3 12 IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 1 Principles of Methodologies Principles of Rate Nephelometry Theory of Operations Principles of Methodologies Principles of Rate Nephelometry The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette The light source for the rate nephelometer is a 670 nm laser The detector is placed at a 90 angle from the laser beam to measure light scatter as shown in Figure 3 1 Principles of Rate Turbidimetry The rate turbidimeter measures the decrease in the intensity of light as it passes through a solution of light scattering particles in a cuvett
277. hes 7 6 cm minimum Top 4 inches 10 1 cm from top of instrument Dimensions Excluding Wash and Waste Bottles Height 30 inches 76 2 cm Depth 25 5 inches 64 8 cm Length 43 5 inches 110 5 cm Weight 250 Ib 120 kg Power Requirements Operating Range Frequency Transient Suppression BTU Generated Electrical Outlet Surge Protector Current Temperature and Humidity 115 90 132 VAC RMS Single Phase 230 180 264 VAC RMS Single Phase 50 60 Hz nominal 47 63 Hz Recommended 2 900 BTU hour Grounded per Local Code Recommended 8 0 Amps normal 12 Amps surge Ambient Temperature 15 C to 32 C Ambient Relative Humidity RH 15 to 85 non condensing Reagent Compartment Temperature 13 22 C 32 C Ambient lt 45 RH Reaction Module Temperature 37 C 0 3 C System Description Page 2 46 IMMAGE 800 Operations Manual A11403 March 2004 Instrument Specifications Drain Requirements Drain Requirements Flow Rate 3 Liters hour minimum Waste Container Placement The opening should be no higher than the top of the instrument Regulatory Agency Approvals The IMMAGE 800 meets the safety requirements for the following agencies CE UL CSA IEC and CENFLEC Environmental Conditions System can operate up to 8000 ft 2 438m elevation Capacities The following table lists various system capacities Table 2 9 System Capacities Item Capacity Reagents 24 reagent cartridges
278. hese errors will not be displayed on the screen but can be found in the Error Log Refer to CHAPTER 10 Utilities The instrument status must be in Standby in order to proceed with the steps below to enable or disable error display mode Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the check box next to Error Display Mode to enable error display mode OR Deselect the check box to disable error display mode Enabling Disabling Continuous Numbering Mode The frame is a basic unit of data transmission When the continuous numbering mode is checked enabled frame numbers from the host will not be reset at 1 with the next header record The instrument status must be in Standby in order to proceed with the steps below to enable or disable the continuous numbering mode Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the check box next to Continuous Numbering Mode to enable continuous numbering OR Deselect the check box to disable Continuous Numbering Mode IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 53 Host Communications Setup Selecting an Operational Mode Selecting an Operational Mode One of three operational modes can be selected or host communications can be turned off completely The three operational modes are described in the IM
279. ices Lab Report Lab Report Dilutions Patient Chartable Reports Select a Report Format OR Select Cancel to return to the previous screen without selecting a report format Select Print Reports F8 The selected results will be printed in the format desired Stopping a Print Request Printing of recalled results can be stopped from the Results Recall Screen by selecting Utilities from the menu bar and lt 10 gt Stop Print Additional Information For information on the default report format setup refer to CHAPTER 5 System Setup Report Setup For examples of result report formats refer to APPENDIX C Reports Results Recall Page 8 12 IMMAGE 800 Operations Manual A11403 March 2004 Sending Results to the Host Introduction Sending Results to the Host Introduction Results from the IMMAGE 800 are automatically sent to the host computer when the autosend is enabled in Host Communications setup Results can be sent manually to the host computer whether autosend is enabled or disabled Manually Sending Results to the Host Follow the steps below to manually send results to the host computer Step Action 1 From the Recall Results By screen select a single sample or range of samples to send to the host computer 2 To select send results to the host Send to Host F8 computer without displaying them display results and send them Display Results
280. ilable Wells 1 Dilution Segment 1 34 zl Dilution Segment 2 36 3 Dilution Segment 3 36 4 Dilution Segment 4 E010293S EPS Figure 11 1 Dilution Segments Dialog Box After Clearing Segments Always replace the cleared dilution segments with unused segments on the sample carousel before a run is started Replacing Dilution Segments The instrument status must be in Standby in order to proceed with the steps below to replace dilution segments Step Action 1 Lift the cover of the sample carousel 2 Rotate the sample carousel by pressing the advance button in order to access the desired dilution segment if necessary Lift the segment to be replaced off the sample carousel 4 Dispose of the used segment in a manner appropriate for biohazardous materials Place an unused segment in the empty position on the sample carousel 6 Repeat steps 2 5 until all desired segments are replaced Additional Information Refer to CHAPTER 7 Sample Programming for more information on Dilution Segments status IMMAGE 800 Operations Manual A11403 System Status Instrument Commands March 2004 Page 11 3 Checking Sample Carousel Status Introduction Checking Sample Carousel Status Introduction The status of each sample on a run can be monitored during the run through Sample Carousel Status The status is indicated by the colored indicator beside the Position Number Sample ID Acces
281. ilable racks 1 6 8 99 Save Cancel F9 F18 Select OK or Cancel E010236S EPS Figure 6 10 Request Calibration Screen Checking and Clearing Racks The rack position used for a calibrator must be Available before it is used for calibration Follow the steps below to check the rack status and clear racks Step Action 1 On the Request Calibration screen check the Available Racks section to see if the rack to be used is Available Available racks have at least one position that is not programmed 2 If the rack is Not Available select Clear Racks F1 Refer to Figure 6 11 1 of 2 IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 27 Requesting and Canceling Calibration Checking and Clearing Racks Step Action continued 3 If then one rack number is entered Press Enter to access the Pos s field Type the position numbers desired to clear up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on the rack are automatically cleared more than one rack number all positions on each rack are is entered automatically cleared the Pos s field cannot be accessed 4 Select lt OK gt to clear the racks and positions OR Select Cancel to return to the Reagent Status Calibration Status scree
282. ilution Volume Reaction Buffer Volume Ca Dilution Compartment A Volume Compartment B Volume Levels 9 Update Level 5 Figure C 11 M306179 M304302 B645 07 31 2005 User Defined 6 Protocol AGXS Limit 21 uL Diluent 300 uL Buffer 1 1 Gain mo JA Sample Dilution Oo uL Reaction Time CALIBRATION INFORMATION Replicates 2 Replicates 2 01 26 2004 11 19 07 USER DEFINED CHEMISTRY DEFINITION REPORT Non Competitive Nephelometric Minutes Cal Setpoint E011446L EPS User Defined Chemistry Definition Report Reports Page C 12 IMMAGE 800 Operations Manual A11403 March 2004 Introduction User Defined Calibration Results Report User Defined Calibration Results Report IMMAGE S N 123 04 22 1998 08 16 34 PAGE 1 USER DEFINED CALIBRATION RESULTS CHEM UDRI REAGENT SERIAL NUMBER A056 UDR BUFFER BUFID Li23456 RGT POS 2 REAGENT LOT NUMBER MBO04052 UDR DILUENT DIL10 L678901 INST RESP ERROR 0 186 0 180 0 131 0 0439 n SD 0 06568 12 i2 12 12 SD 0 1204 22 buon 25 0 25 0 25 0 25 0 50 0 1153 AA gt gt gt 50 0 50 0 50 0 50 0 SD 0 1708 4 A 4 A 4 A 4 A 150 150 150 150 SD 0 7274 naan gt gt gt 200 200 200 200 SD al nana gt gt gt 300 300 300 300 SD 6 40 P gt gt gt E014065L EPS Figure C 12 User Defined Calibration Results Report IMMAGE 800 Operations Manual A11403 Reports March
283. ion This cautionary label is located at the top of the optics module to laser light beam CAUTION DE LASER LIGHT AVOID DIRECT EXPOSURE TO BEAM 670 nm 10mW CLASS III B LASER PRODUCT 447099 AA A010648L EPS Class III B Laser Caution Label Reagent Compartment Cover Notice Symbols and Labels Class IIl B Laser Caution Avoid direct exposure This label is located on the reagent compartment cover The instrument will stop if the cover is opened INSTRUMENT WILL STOP IF COVER IS OPENED 447069 AA A010647L EPS Reagent Compartment Cover Label IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 13 CHAPTER 2 System Description Table of Contents Hardware Components Li NRI RI UA TURNUS Uns a ruo Urna ee ER vague due aa E e M PUR IRR TUER 2 2 SR Lc sd Los Duet oc lost ed Jada ced iocis 2 2 WPS EUR TIL iii 2 3 Reagent Compartment a 2 4 O e EA 2 6 Reaction Module E 2 8 Sample Cards ME E E E EN 2 10 A E E E E E OUR RU To Rp a S 2 12 Upper Instrument Subsystems ers o e ds 2 14 Wash Solution Box and Waste Container eeessseeseeeseseeeeee eene enne nennen enne enne 2 17 Racks gestern pie DIR A da ns etek ac vd dnt 2 19 Computer EP cis 2 21 luu EI th le 2 25 SoftWare OVErVIEW o et hes iol sat act te ks iste oe dece Dette cipe OR unte AN III DET 2 26 MV CLV IC UR
284. ion Date 61 61 1998 Buffer s BUFL a Diluent s DILL 8 Calibrator CAL 1 E010299S EPS Figure 6 4 Reagent Lot Parameters Dialog Box Deleting Reagent Parameters The instrument status must be in Standby in order to proceed with the steps below to delete reagent parameters Step Action 1 Select Rgts Cal from the menu bar 2 Select Reagent Summary F2 Refer to Figure 6 3 3 Select a button beside the Chem lot to be deleted OR Select lt Go To gt and type the Chem and Lot number Refer to Figure 6 5 4 Select lt Delete gt Select lt OK gt from the Delete Reagent Lot Confirmation dialog box to delete the parameters OR Select lt Cancel gt to return to the Reagent Summary dialog box without deleting parameters Delete Reagent Lot Confirmation Delete the following reagent lot IGG 561195 All calibration results for this reagent lot will also be deleted OK Cancel E010300S EPS Figure 6 5 Delete Reagent Lot Confirmation Dialog Box Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 8 March 2004 Loading Clearing Buffers and Diluents Introduction Loading Clearing Buffers and Diluents Introduction Reaction buffers and sample diluents must be placed on the IMMAGE 800 and their positions and lot numbers must be entered into the computer Limits Up to 4 bottles of reaction buffer may be placed on the inner section of the reagent car
285. ion of an action If this button is selected no data is entered no action is performed the dialog box closes This button can also be selected by pressing Alt c Some dialog boxes will have an OK button This button accepts the data being entered or confirms a user s request for an action If this button is selected the data is entered into the system or the action is performed the dialog box closes This button can also be selected by pressing Alt 0 Print or Display Some dialog boxes may contain Print or Display buttons IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 37 Deleting Data From a Text Field and Printing Data from a Screen Deleting Data from a Text Field Deleting Data From a Text Field and Printing Data from a Screen Deleting Data from a Text Field Follow the steps below to delete data from a text field Step Action 1 Choose the text field 2 Choose one Press the Delete key to delete the entire field Press the Backspace key to delete a single character prior to the cursor Drag through any portion of the text to highlight it and then press the Backspace key to delete the highlighted text Printing Data from a Screen Many screens contain data that may be printed by selecting Print F10 Printing a Screen Any screen can be printed by pressing Ctrl P simultaneously System Descri
286. ion programs for the UDR Editing Comments the Cartridge Serial Number and or refilling a cartridge will not affect calibration Editing anything else clears the calibration programs cancels the calibration clears the AGXS Limit and disables AGXS flagging The edited UDR definition is saved with the same chemistry name Refer to Table 5 11 for further information Table 5 11 UDR Editing Function Editing Function Calibration Calibration Curve Fit Rack Status Model Clears calibration programs Cleared Calibrated Cannot Change Clears calibration programs and Cleared Uncalibrated Cannot Change Cancels the calibration System Setup IMMAGE 800 Operations Manual A11403 Page 5 86 March 2004 Editing UDR Definitions Editing a UDR Definition Editing a UDR Definition The units and chemistry name of the UDR cannot be changed unless the UDR is first removed from the chemistry menu The instrument status must be in Standby in order to proceed with the steps below to edit a UDR definition Step Action 1 From the Setup screen select lt 18 gt User Defined Chemistries 2 Select a number beside a defined UDR position Refer to Figure 5 28 3 Select Define Edit F1 4 Refer to Defining a UDR Chemistry to edit the UDR definition and calibration information NOTICE Editing the sample dilution or AGXS Limit of a defined UDR clears the calibration programs for that UDR Editing Comments Cartridge S
287. ions button lt W gt next to the Sample Comment field on the Program Sample screen is an example of a button IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 31 Toggle Buttons Function Toggle Buttons Function Toggle buttons function in the same manner as buttons except when they are selected or pressed their state is changed Selected or Unselected Toggle buttons may either be in the selected or unselected state If a toggle button is selected it will be highlighted in blue Example Each chemistry button in the list of chemistries on the Program Sample screen is an example of a toggle button System Description IMMAGE 800 Operations Manual A11403 Page 2 32 March 2004 Check Boxes Function Check Boxes Function Check boxes are similar to toggle buttons because they are either toggled on or off When selected a check box will change state States A check box is either checked or unchecked When checked a check mark will appear in the check box Example The STAT check box on the Sample Program screen is an example of a check box IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 33 Performing Software Functions Introduction Performing Software Functions Introduction The IMMAGE 800 Immunochemistry System uses a graphical user interface Functions can be performed by using a mouse to point and click with keyboard equivalents or with an optional t
288. ior to multi point calibration The single point calibration update result is compared to the multi point calibration and the system calculates a scale factor After the update is approved the scale factor is applied to quality control results and patient results The instrument status must be in Standby in order to program a single point UDR calibration Program a single point calibration as follows Step Action 1 From the User Defined Chemistries screen select Request Cal F4 Refer to Figure 5 28 The UDR chemistries on the reagent carousel will be displayed 2 Select up to six UDR chemistries for calibration Select OK to continue OR Select Cancel to return to the User Defined Chemistries screen 4 From the UDR Cal Assign screen select check the single point update box The predefined update single point level and the Cal ID fields will be enabled Refer to Figure 5 43 5 From the UDR Cal Assign screen enter an available rack number in the Rack field OR Select Clear Racks F1 and enter the racks and or positions to clear Select OK to clear or Cancel to exit without clearing 6 After a rack number is entered fill in the Pos field according to the level defined for the chemistry displayed 7 Enter a Cal ID in the Cal ID field optional Up to 18 characters may be entered 8 Select Save F9 or a menu bar icon to save the calibration program for the displayed chemistry OR
289. is Not CLINICAL SUPPORT Filling 2439 Internal Wash WARNING CALL BECKMAN COULTER Bottle has CLINICAL SUPPORT Exceeded Maximum Fill Time 2440 Reagent WARNING Will STOP Close reagent compartment cover Compartment Run Lid is Open 244 Reaction WARNING Will STOP Close reaction compartment cover Compartment Run Lid Open 2442 Thermal Flag WARNING CALL BECKMAN COULTER Failure CLINICAL SUPPORT 2443 Card Cage WARNING CALL BECKMAN COULTER Temperature Out CLINICAL SUPPORT of Range Low 2444 Card Cage WARNING CALL BECKMAN COULTER Temperature Out CLINICAL SUPPORT of Range High 2445 Vacuum WARNING Will STOP CALL BECKMAN COULTER Reservoir Full Run CLINICAL SUPPORT 2446 Internal Wash WARNING Will STOP CALL BECKMAN COULTER Bottle float Run CLINICAL SUPPORT switch is disconnected 2447 New failed FATAL CALL BECKMAN COULTER Sending Status CLINICAL SUPPORT Monitor message to Console 2800 ISS Semaphore FATAL CALL BECKMAN COULTER Create Error CLINICAL SUPPORT 2801 Test Object FATAL CALL BECKMAN COULTER Pointer and Tog CLINICAL SUPPORT Mismatch 20 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 42 March 2004 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message 2802 Invalid Reagent FATAL CALL BECKMAN COULTER Type from CLINICAL SUPPORT Reagent Handler 21 of 21 IMMAGE 800 Operati
290. istries System Setup IMMAGE 800 Operations Manual A11403 Page 5 2 March 2004 Accessing Setup Overview Accessing Setup The instrument status must be in Standby in order to proceed with the steps below to access the Setup screen Step Action 1 Select Setup from the menu bar 2 Choose the desired setup option from a numbered button Refer to Figure 5 1 Standby Host Off SMO Mik a s Main Samples Results Rats Cal z Panels 3 Bar Code 4 Reference Interval 5 Report Setup 6 Calculations 7 Un its Non Standard Dilutions 8 antigen Excess _ 9 Date Time 18 Host Communications Enter the function number Figure 5 1 t Setup Utils Status Stop F12 About 11 Default Setup _12 Sample Comments _13 Denographics Setup 14 Printer Setup 15 Languages Keyboard _16 Chemistry Protocol Diskette 17 Instrument Serial Number 18 User Def ined Chemistries E011414S EPS Setup Screen IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 3 Configuring the Chemistry Menu Introduction Configuring the Chemistry Menu Introduction The chemistry menu available in the sample programming quality control panel definition and other screens is defined by the individual laboratory The menu contains up to 72 chemistries Defining a Chemistry for a Position The instrument status must be in Standby in order to proceed with the steps below to
291. istry displayed The calibrators must be programmed in ascending concentration with Level 1 being the lowest concentration 6 Enter a Cal ID in the Cal ID field optional Up to 18 characters may be entered 1 of 2 System Setup Page 5 96 IMMAGE 800 Operations Manual A11403 March 2004 Calibrating a UDR Chemistry Programming a UDR Calibration programs Step Action continued 7 Select Save F9 or a menu bar icon to save the calibration program for the displayed chemistry OR Select Cancel F10 to exit the screen without saving any calibration chemistries 8 Repeat Steps 4 7 to program additional racks for calibration of other UDR UDR Request Cal Chem Lot Remaining Cal Status 37 UDR1 M8804052 308 Uncalibrated 2 Cancel E014051S EPS Figure 5 41 UDR Request Cal Dialog Box Samples Results UDR Cal Assign Chem Name UDR3 Available Racks 2 3 5 8 18 11 13 29 31 39 41 99 i Clr UDR Save Fi F6 Enter Rack Number 1 99 E014052S EPS Figure 5 42 UDR Multi point Cal Assign Screen 2 of 2 IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 97 Calibrating a UDR Chemistry Programming a Single Point UDR Calibration Programming a Single Point UDR Calibration A single point calibration update can be performed on a UDR after a multi point calibration has been performed and approved This option is not available pr
292. itional samples A message will display if there is not enough information entered to save the sample program If a minimum of a sample identifier Rack and Position or Sample ID and a chemistry is programmed for a sample the sample program will be automatically saved if the Program Sample screen is exited without selecting Save Next F10 Automatic Incrementing If a Rack number and Position number are entered for the current sample selecting Save Next F10 will automatically increment to the next position within the rack according to the following guidelines Table 7 8 Automatic Incrementing If the next position on the rack is then Save Next will display not programmed a blank Program Sample screen with the current Rack and a new Position programmed but not run the corresponding sample program complete incomplete or the next position on the rack that is not programmed for a rerun or programmed or is programmed but not run calibrator Selecting Save Next F10 from the last position on a rack will display a blank Program Sample screen Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 44 March 2004 mM T7 Programming a Batch of Samples Overview Introduction Multiple samples can be programmed as a batch with the same chemistries Sample Type Sample Comment and Sample Options Up to 100 samples can be programmed in a batch A maximum of 72 samples can be pl
293. kin should wear protective gloves before attempting to work with reagents and other chemical preparations Do not handle sample or solutions without proper protection Body fluids and other infectious samples must be handled according to good laboratory practice to prevent spread of disease When performing maintenance service or troubleshooting on elements of the system that have contacted sera or other biological fluids observe standard laboratory precautions It is always necessary to wash your hands thoroughly after performing any routine maintenance Dispose of all waste solutions according to appropriate environmental health and safety guidelines Safety Notice IMMAGE 800 Operations Manual A11403 Page 2 of 2 March 2004 CHAPTER 1 General Information Precautions and Hazards Table of Contents General Information Precautions and Hazards essere eene nennen 1 2 Diligo S De HL TENER EET 1 2 How to Use This Manual naian O E E no nono senten nete an nene ase 1 3 Warranty and Service Policy Information viii tacet ec ds 1 5 Precautii onsa eoar Mee eee m MEM M M AEE MG ES 1 6 Haz tds 1 e a tia is 1 7 Symbols ANCL ADEIS 5 ccc ie aaa leetyan suited a a a a E E aE Aa S 1 9 IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 1 Introduction Intended Use General Information Precautions and Hazards Introduction Intended Use The Beckman Coulter IMMA
294. l ASTM protocol A standardized computer interface specification following the guidelines from the American Society for Testing and Materials Bar code card A Beckman Coulter provided card which is imprinted with bar codes The card contains either Reagent Parameters or Calibrator Parameters to input lot specific information into the IMMAGE 800 system Bar code reader A device on the instrument that scans and decodes bar codes Batch A group of samples with the same sample programming information except for Sample ID IMMAGE 800 Operations Manual A11403 Glossary March 2004 Page 1 of 6 Baud rate Baud rate The serial data transfer speed between two or more communication devices One baud equals one signal event change in frequency phase angle or voltage transmitted per second Bidirectional interface Two way transmission of information from the host computer to the instrument usually sample programming and from the instrument to the host computer usually results Buffer Reaction medium for most protein and drug chemistry reactions Buffer type A specific type of reaction medium such as Buffer 1 BUF 1 CMOS An acronym for Complementary Metal Oxide Semiconductor the components of the computer battery that stores the internal clock and PC configurations Calculation Beckman Coulter defined A calculation formula supplied by Beckman Coulter which is uneditable and undeletable Callable diagnostics
295. l beads e a 10 12 10 13 Name ous err e Ree i t cin m ire nnns 7 26 Patient comment 7 27 PatientID i RUD eve ERU i 7 26 D SA a attains tete ev Iudae 7 26 Demographics SCreen oooooocooocooooo 7 25 Data reduction 02000 eee eee 2 58 Dialog box 2 0000 eee 2 37 Database after power is restored 4 5 Dilution segments 2 11 7 3 7 6 11 2 Date ar Lor bee Ge Et n Ene 5 44 5 47 Dilution segments dialog bOx 11 3 CHANGING 5 o Een ha ane a ea REGERE ERE 5 47 Dilution segments status o oooo 11 2 Formatting ori niI ease tae ea eae aa 5 44 DIMENSIONS 225 cee eee ee ee oe ee ee 2 46 Date time dialog box event log 10 48 Disabled demographic fields 7 25 Decision table 00 e eee eee eee 1 4 Disabling automatic printing Index IMMAGE 800 Operations Manual A11403 Page ii of vii March 2004 Calibration report s s auauua sanaan 5 26 Yar format e DR Ta ie aoe A 5 44 Control report eee ee 5 26 Year Month Day eese 5 44 Patient report else 5 26 Formatting the time Display at eo A Ee eniin 2 37 T2 DOUE vs St noe IUE HORROR ek hates EA 5 46 Display events dialog DOX 10 47 24 NOU e ce ore we Rey eed 5 46 Displaying a load list Date time custo leid he ek 5 46 Load list screen 00 0c eee lesen 7 75 Hour format cion acl sie ae te eared Apes 5 46 Displaying ca
296. lation 2 Select the options button W beside the Units field 3 Select the number for the desired unit 4 Enter the reagent lot number in the Reagent Lot Number field 5 Select the options button lt W gt beside the Protocol field 6 Select the number for the desired protocol 7 Select the Cartridge Lot Number field 8 Enter the cartridge lot number from the UDR cartridge The lot number is found on the bar code label of the UDR cartridge supplied by Beckman Coulter 1 of 2 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 79 Defining a UDR Chemistry Beginning a New UDR Protocol Definition Step Action continued 9 Select the options button lt W gt beside the Reagent Expiration Date field 10 Enter the reagent expiration date NOTICE The expiration date must not be the current date Recalibration will be necessary when the expiration date is changed 11 Select lt OK gt to enter the expiration date into system OR Select lt Cancel gt to exit the dialog box without entering the date Continue to Defining UDR Sample Reagent Volumes 12 Enter the reagent cartridge serial number in the Cartridge Serial Number field The serial number is found on the bar code label of the UDR cartridge supplied by Beckman Coulter 13 Enter the number of tests in the Tests per Cartridge field The maximum number of tests is 300 14 If desired select the Comments field and ent
297. le Calibration The calibration status of the test changes to Cal Re enable 2 The calibrations display ascending date time order with the oldest calibration listed first 3 Select lt OK gt to return to the Reagent Status Calibration screen IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 21 Cartridge Specific Calibration Introduction Cartridge Specific Calibration Introduction The cartridge specific calibration option provides calibration of partially used cartridges The calibration factor established from a fresh cartridge can be stored and applied to all subsequently loaded cartridges of the same lot Explanation of Terms The table below defines terms specific to cartridge specific calibration for the IMMAGE 800 Table 6 4 Cartridge Specific Calibration Terms Term Explanation Reagent Lot Calibration of a fresh cartridge to be applied to all cartridges with the same lot number Cartridge specific Calibration of a partially used cartridge to be applied to that cartridge only The system determines the cartridge to be used for this calibration based on criteria described below Refer to Cartridge Specific Calibration Criteria Predetermined number of The number of tests remaining in a cartridge to allow a tests cartridge specific calibration This number is determined by Beckman Coulter on a per chemistry basis and is coded into the reagent bar co
298. le buttons 0 20005 2 32 2 36 Westgard rules 200 9 2 9 3 9 4 Tools and supplies 000 e eee eee 10 4 VOX eruere gical kate a Rp 9 5 Touch Screen o 2 35 10 68 j 9 2 Calibrating elm ae ote 10 68 Dr ir wr peur PW E 9 2 TUBING 5 eek deben Regt cide uS 10 8 2 259 Ul8 23 a eben e Due pte ades 9 4 Typesofracks llle 2 19 Ad S oleo ru ee Rec uu r v Ron echt 9 4 PEAS TU Oia o RR m Senta Ate 9 4 U Working area 1 1 eee 2 29 Unidirectional 2 0 0 0 0 0 0 cee eee eee 2 45 Z Dilution segments 0 0s eee eee 7 83 Uninterruptible power source UPS 2 22 4 2 Z SCOIG cose dae Rh aed ho be d bas 9 3 9 4 Units categories o oooooooommoomoo 5 39 Unlinking samples 0 0 0c ee eee 7 36 UPS ac ia 4 2 Urine Transferrin TR ooooocoocoocoooo 3 8 User defined reagent UDR 5 68 Approving a UDR calibration 5 107 5 108 Calibration informati0N 5 84 Order of reaction 0 000 e cece eae 5 78 Precautions opnara io e ia p i e Aia e a ea 5 68 Protocol citaciones ERR da 5 75 Protocol definition o ooooooooo 5 79 Rate mode er aaia e E 5 93 Sample reagent volumes Ls 5 81 UDR calibration 5 96 5 98 UDR definition ooooooooooooooo 5 87 User defined reagent chemistry setup 5 68 Approving a single point UDR
299. lect Devices F2 Select either 11 Sample syringe or 12 Reagent syringe Select 3 Aspirate volumes Oo CO NIAJ NY BY wy t2 Enter 125 for the sample syringe or enter 250 for the Reagent Syringe select lt OK gt 1 of 2 Utilities IMMAGE 800 Operations Manual A11403 Page 10 20 March 2004 As Indicated Maintenance Replacing Syringes Step Action continued 10 Unscrew bottom syringe screw 1 and top syringe screw 2 Refer to Figure 10 16 AO10025PEPS Figure 10 16 11 Remove syringe for replacement AO10026PEPS Figure 10 17 12 Insert new syringe 13 Select Main from the menu bar 14 After the status returns to Standby prime the system and observe syringes for leaks or bubbles Refer to Daily Maintenance Procedures Priming in this chapter 15 Run controls to verify system performance 2 of 2 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 21 Errors Error Messages Troubleshooting Errors Error Messages The following table describes the types of error messages generated by the system Error messages contain an explanation of the problem as well as an error number for reference in the Error Table Errors are also logged in the Event log For retrieval of events refer to Event Log in this section Table 10 6 Error Messages Location Explanation Remarks column of patient Syste
300. les Load List F9 Requests a load list Save Next F10 Saves the current sample program and allows programming of the next sample Additional Information Refer to CHAPTER 2 System Description Performing Software Functions for general information on using the software IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 13 Entering Sample Identification Introduction Entering Sample Identification Introduction Every sample must be identified by either Rack and Position or Sample ID Both Rack and Position and a Sample ID can be entered for a sample Minimum Sample Program Required The minimum information required for a sample to be saved is Rack and Position and at least one chemistry OR Sample ID and at least one chemistry Assigning a Rack and Position Follow the steps below to assign a Rack number and Position number NOTICE A Rack number and Position number must be assigned if a sample is not bar coded or if a sample bar code is unreadable Step Action 1 Select Samples from the menu bar Choose the Rack field if the cursor is in another field 2 3 Type an available Rack number 1 99 and press Enter 4 Type a Position number 1 9 Entering a Sample ID Follow the steps below to enter a Sample ID Step Action 1 Select Samples from the menu bar 2 Choose the Sample ID field if the cursor is in another field
301. librator lot parameters 6 36 Leading zero 01 0 0 0 0 e eee eee 5 46 Calibrator lot display dialog box 6 37 No leading zero 1 0 0 0 0 ee eee eee eee 5 46 Calibrator summary dialog box 6 36 Separator field ooooooooooooooo 5 46 Displaying reagent parameters 6 7 Time formate siars 0 0 cee eee ee 5 46 Reagent lot parameters dialog box 6 8 Function button 0 0 eee eee eee 2 34 Reagent summary dialog box 6 7 Function button description Displaying editing a sample program 7 15 Buffer diluent ooooococoocoonooo 6 4 Disposal of waste liquidS 1 8 Gal ldLiSt ettet core E oo REDI 6 4 Drain requirements 0 0 eee eee 2 47 Gal OPtiOnS ticos ie letra aes 6 4 Drug rate response curve lle lesen 3 7 Cancel request 0 0 0 eee eee esses 6 4 Dynamic blanking llle 3 4 Read cards uisus loe ee adie TRE eee 6 4 Read reagent 20 cee eee eee eee 6 4 Reagent summary 0 0 0 eee eee eee 6 4 E Request cal sge cde ir ie eee eee ee 6 4 Function buttons o oooooooo 2 28 2 34 Editing a control 9 12 Functional area 0 eee eee 10 53 Editing a sample comment 5 61 Editing panels Clear chems 00000 elle eese 5 11 G Editing programs before rerun Clear chems 00000 c eee eee eee eee 7 66 Graphic
302. llle an pela eed aad 5 51 Data bits roe ee ea T E 5 51 Party ueri RERIRNERDURXRGROGENGG CER cede 5 51 SOP DIIS ce oet x RE ERI EUER ras 5 51 Setting system replicates statistics System replicates field 5 58 Setting the default sample type Default sample type 2 0000 5 57 Default setup dialog DOX 5 58 Setting the timeout value Tribute iii hoop ec eats data Rb dai 5 52 10 minutes ik erg robo 5 52 2 miDUtes ix E ES RYE REA S 5 52 A miri tes 2 eie RR ita ERE DE 5 52 YA MINUTES MM Le 5 52 Timeout value 2 2 eee ee 5 52 Set p xb tea tee hei nae 5 3 Setup screen 00 cee eee 5 3 Soluble complexes 0 000 e eee eee eee 3 4 Standard deviation oooo oo ooo 7 38 9 6 Starting a calibration fUN o o oo 6 33 Starting the run eese 7 55 Start Upe L a a A eed 2 festa 2 57 STAT calibrati0N ooooo ooo o 6 26 7 43 STAT samples sess 7 43 Statistics cdi uero rk eat Ki DENT DS 9 3 Stats 2s s ERR mc teet ten eee Meus 11 4 11 6 Status Dal ius paio kp Eur ien a E EGER 2 27 Status monitor screen llle eee eee 11 6 Status monitor temperature sensor 2 9 Stir Moto e pared NI Moses 10 51 Stopping a print request 5 8 12 Symbol content iles esee 2 52 Symbol size 1 eee 2 52 Syringes i it ae Be EE Reed e 10 8 System calibration Calibration scale factor o o
303. log box chemistries must first be selected from the Program Sample screen Refer to Figure 7 7 Sample Options allows the designation of the number of replicates for an entire sample or for individual tests the enabling or disabling of antigen excess testing the selection of non standard dilutions the entering of an off line dilution factor the linking and unlinking of two samples for a calculation the setting of variables for use in Custom Calculations Sample Options System Replicates Sample Replicate L Off line Dilution Factor 1 No eStuRdRRd E T Chem AGXS Reps Dilution Chem AGXS Reps Dilution an AO C Link Set 2 OK c 1 Sample Uariables o Cancer E014093S EPS Figure 7 7 Sample Options Dialog Box Exiting the Sample Options Dialog Box Select OK to save the information and return to the Program Sample screen OR Select Cancel to return to the Program Sample screen without accepting any changes Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 28 March 2004 Selecting Replicates 7 Introduction Selecting Replicates Introduction A Sample Replicate number can be entered in the Sample Replicate field The Sample Replicate number defines the number of times all tests selected for the sample will be repeated 1 9 Sample Replicates are available It applies only to the current sample The default number of sample replicates defined in Setup is displayed
304. lution volume Refer to Preparing for Programming Running in this chapter Request calibrations if necessary Refer to CHAPTER 6 Reagents Calibration 1 of 2 Sample Programming Page 7 80 IMMAGE 800 Operations Manual A11403 March 2004 Overview 7 Operating in Host Query Mode Step Action continued NOTICE If a position is programmed by a bar coded tube with host query the position will automatically clear when a new bar coded tube is read in that position The new bar coded tube can then run as a result of the host query for that position All manually programmed positions must be cleared manually in order to run any other samples in those positions If a bar coded tube with a host query is run in a position previously manually programmed the position will not automatically clear A conflict warning message will display If samples are then bar coded load samples in any rack and position not bar coded program rack and position and sample ID for each sample Load samples in the programmed racks and positions Refer to Programming a Sample in this chapter Refer to CHAPTER 2 System Description Sample Container Information 4 Select Main from the menu bar AND Select Run 5 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run 2 of 2 IMMAGE 800 Operation
305. m is unable to obtain a valid answer report Instrument errors on patient A code to indicate that the system is operating in a report user modified mode Green border pop up window INFORMATIONAL MESSAGE only on screen Yellow border pop up window WARNING MESSAGE system performance may on screen need to be reviewed Operation will continue unless startup checks have failed Red border pop up window on FATAL WARNING message system performance screen must be reviewed and operation will cease Using the Error Table Table 10 7 is useful to look up an explanation of any displayed or printed error messages Error messages with the prefix E are found on patient reports e g E10 Error messages without a prefix are displayed as pop up windows e g 10 The Action column is prioritized with the most likely solutions appearing first Call Beckman Coulter Clinical Support as a final resolution NOTICE The Status Monitor screen updates every three seconds with out of range results highlighted in red and should therefore be observed for several minutes to verify proper instrument performance Refer to CHAPTER 11 System Status Instrument Command Checking the Instrument Status Monitor Utilities IMMAGE 800 Operations Manual A11403 Page 10 22 March 2004 Errors Error Table Error Table Table 10 7 Displayed or Printed Error Messages Error A
306. mistry Information Manual for appropriate measuring range E59 ORHI High Result Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual for appropriate measuring range E60 RXN Error No Reaction AGXS CALL BECKMAN COULTER failed CLINICAL SUPPORT E61 ORLO No Reaction excluding Refer to IMMAGE Immunochemistry Drugs Systems Chemistry Information Manual for appropriate measuring range E62 RXN Error No Reaction Drugs CALL BECKMAN COULTER CLINICAL SUPPORT 5 of 21 IMMAGE 800 Operations Manual A11403 March 2004 Utilities Page 10 27 Errors Error Table Table 10 7 Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message E63 ORLO Unstable Reaction Refer to IMMAGE Immunochemistry excluding Drugs Systems Chemistry Information Manual for appropriate measuring range E64 RXN Error Unstable Reaction 1 Verify all constituents reagents Drugs samples buffer diluents and segments are available 2 Rerun sample E65 ORHI High Result Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual for appropriate measuring range E66 RXN Error Unstable Reaction CALL BECKMAN COULTER CLINICAL SUPPORT E70 Invalid Cal Invalid Calibration Type 1 Reread reagent card Incorrect Reagent Card or 2 Reread calibration card Bad Read E71 Cal Reps Too Few Calibrators Repeat calibration Need Two or M
307. mple Stir Motor and Reagent Stir Motor The Sample and Reagent Stir Motor option is used to test or to verify The revolutions per minute of the Sample and Reagent Stir Motors The straightness of the Sample and Reagent Mixer Paddle Follow the steps below to measure motor speed or test paddle straightness Step Action 1 Select Utilities from the menu bar 2 Select lt 3 gt Diagnostics from the Utilities screen OR Enter 3 in the Option No field 3 Select lt 2 gt Callable Diagnostics from the Diagnostics dialog box OR Enter 2 in the Option No field and press Enter of 2 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 51 Callable Diagnostics Sample Stir Motor and Reagent Stir Motor Step Action continued 4 If then Sample Stir Motor is Select lt 10 gt Sample Stir Motor from desired the Callable Diagnostics screen OR Enter 10 in the Option No field and press Enter Reagent Stir Motor is Select lt 11 gt reagent stir motor from desired the callable diagnostics screen OR Enter 11 in the Option No field and press Enter 5 Observe the Mixer Paddle for sway or wobble during motor exercise Replace the Mixer Paddle if necessary Refer to Replacing Parts User Servicing Sample and Reagent Crane Mixer Paddle in this chapter 6 Verify that the Speed of Motor displayed at the end of the motor exercise is within 6000 to 10000
308. n HPT Urine Transferrin TRU Alpha 1 Microglobulin A1M Microalbumin MA and Albumin ALB which are identified by the system as ambiguous are tested for antigen excess condition if AGXS testing is enabled Refer to CHAPTER 5 System Setup Configuring Antigen Excess Testing A reaction is ambiguous if the rate response could represent either an antigen excess or an antibody excess reaction Antibody Excess When the reaction is to the left of the optimal antibody antigen proportions center line the reaction is in antibody excess AbXS Refer to Figure 3 7 This indicates all the antigen in the sample is bound forming complexes This is the ideal condition for the reaction to take place Antigen Excess When the reaction is to the right of the optimal antigen antibody proportions center line the reaction is in antigen excess AgXS and the rate response will start to decrease due to excessive levels of antigen Refer to Figure 3 7 Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3 8 March 2004 Antigen Excess Testing Ambiguous Response Ambiguous Response It is possible for two significantly different sample concentrations of antigen to yield the same rate response Either the rate response represents the correct concentration in the area of AbXS left side or the same rate response represents a concentration that is in the area of AgXS right side and requires further dilution Antigen excess testi
309. n without clearing 5 If the calibrator sample then is bar coded Select Save F9 to save the request OR Select Cancel F10 to return to the Reagent Status Calibration Status screen without saving not bar coded Go to Assigning Calibrator Rack and Position in this section 2 of 2 Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 28 March 2004 Requesting and Canceling Calibration Assigning Calibrator Rack and Position Clear Racks Clear Racks Positions OK Cancel E010237S EPS Figure 6 11 Clear Racks Dialog Box Assigning Calibrator Rack and Position A non bar coded calibrator must be assigned a rack and position when requesting calibration Follow the steps below to assign rack and position to a non bar coded calibrator sample Step Action 1 From the Request Calibration screen type the Available rack and position for the calibrator in the Rack and Position fields 2 Select the options button lt W gt beside the desired position for the calibrator 3 From the Calibrator Lots dialog box select the appropriate calibrator lot number OR Select Cancel to return to the Request Calibration screen without selecting a calibrator lot number 4 Select Save F9 to save the calibration request and assignment OR Select Cancel F10 to return to the Reagent Status Calibration Status screen without saving Canceling a
310. n example of a hapten Host query A form of bidirectional interface communication When the instrument reads a bar coded sample ID for which it has no program the host computer is queried for the program associated with that sample The host then sends the queried information to the system Icon A small pictorial representation of a functional area The icons are found on the menu bar at the top of the screen Intercharacter gap The space that separates two characters in a bar code Inter lab A Beckman Coulter QC program Laboratory information system LIS A laboratory host computer that can be interfaced to an IMMAGE 800 System Microtube A sample tube manufactured by Beckman Coulter which is intended for low volume samples and can be bar coded Glossary IMMAGE 800 Operations Manual A11403 Page 4 of 6 March 2004 Multipage list Multipage list A feature of the IMMAGE 800 interface that lists more than one screen page of information e g chemistries The multipage list includes Page Up and Page Down keys for next page scrolling Numeric character 0 9 Offset A value which is added or subtracted following the application of a slope value to a chemistry result On board reagent The chemistries buffers and diluents that are currently loaded onto the system Panel A group of tests that are ordered together Parity A method of detecting serial data transmission errors Patient demographics Inform
311. n individual chemistry The enabling or disabling of AGXS from Sample Options applies only to the current sample If AGXS testing is applicable to a chemistry a check box appears beside that chemistry in the Sample Options dialog box AGXS Testing Default The default for AGXS testing is defined in Setup and indicated by the check box Refer to Table 7 6 Table 7 6 AGXS Testing Every time the test is run it will be tested for antigen excess When the check AGXS testing is And on the Program Sample box is screen checked enabled for the chemistry a small green box appears on the chemistry button on the chemistry menu unchecked disabled for the chemistry The chemistry will not be tested for antigen excess there is no green box on the chemistry button on the chemistry menu Enabling Disabling AGXS Testing Follow the steps below to enable or disable AGXS testing Step Action 1 Select Sample Options F3 from the Program Sample screen 2 Choose the AGXS check box beside the desired chemistry 9 Select the check box to toggle it to checked or unchecked Additional Information Refer to CHAPTER 3 Theory of Operation Antigen Excess Testing for more general information on antigen excess Refer to CHAPTER 5 System Setup Configuring Antigen Excess Testing for more information on defining the default for AGXS testing Sample Programming Page 7 30
312. n the Panel No s field or by selecting the panel from the Panels list The maximum number of panels which can be selected is the number that was defined in Setup NOTICE Panels defined using previous versions of software and restored to version 1 5 will have a sample type of Unknown Panels having a sample type of Unknown cannot be used in Sample Programming Refer to CHAPTER 5 System Setup Panel Setup Editing Panels to edit a sample type Selecting a Panel by Number Follow the steps below to select a panel by number Step Action 1 Select Samples from the menu bar 2 From the Program Sample screen choose the Panel No s field 3 Type the desired panel number s in the Panel No s field Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 4 Press Enter Selecting a Panel from Panels List Follow the steps below to select a panel from the Panels list Refer to Figure 7 3 Step Action 1 Select the options button lt W gt beside the Panel No s field 2 Type the desired panel number s Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 Press Enter OR Select the number beside the desired panel s 3 Select OK to program the panel s OR Select Cancel to return to the Program Sample screen without programming the panels Sample Programming IMMAGE 80
313. nations of sample programming refer to CHAPTER 7 Sample Programming of this manual Table 2 8 Sample Programming Options Bar Coded Host Interface Sample Programming Samples Yes Host Query None required Load samples in any rack and position No Bi directional None required Load samples in rack and position assigned by host Yes Bi directional None required Load samples in any rack and position No Unidirectional Required Enter rack and position number sample ID and chemistries Load samples in assigned rack and position Yes Unidirectional Required Enter sample ID and chemistries Load samples in any rack and position No None Required Enter rack and position number sample ID demographics and chemistries Load samples in assigned rack and position Yes None Required Enter sample ID demographics and chemistries Load samples in any rack and position IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 45 Instrument Specifications Placement System Specifications and Characteristics Instrument Specifications Placement The surface on which the unit rests must be free of vibration and must be level 1 or 0 75 inch 1 9 cm slope across the length and the width of the instrument Do not place instrument in direct sunlight or drafts or near a heating or cooling duct Clearance Sides 6 inches 15 2 cm minimum Back None Front 3 inc
314. nce Intervals and Panels UDR Reference Interval and Panel Setup Setting Up UDR Reference Intervals and Panels UDR Reference Interval and Panel Setup UDR reference intervals and panels are defined like other Beckman Coulter chemistries from the Reference Interval Setup and Panel Setup screens Refer to Reference Interval Setup Defining Editing Intervals and Ranges and Panel Setup Defining New Panels in this chapter IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 115 Defining UDR Quality Control UDR Quality Control Definition Defining UDR Quality Control UDR Quality Control Definition UDR quality controls are defined like other Beckman Coulter chemistries from the Quality Control screen Refer to CHAPTER 9 Quality Control Defining a Control System Setup IMMAGE 800 Operations Manual A11403 Page 5 116 March 2004 Programming a UDR Sample UDR Programming Reference Programming a UDR Sample UDR Programming Reference The UDR chemistry is programmed like an other Beckman Coulter chemistry from the Program Sample screen except that AGXS check cannot be chosen Refer to CHAPTER 7 Sample Programming IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 117 Overview Introduction Instrument Setup Overview Introduction Some parts of the instrument hardware require a one time setup prior to a sample run This section explains Rack bar code label placeme
315. nd or variables per calculation and press Enter to continue The order of precedence when using mathematical operations in a calculation formula are Ist brackets 2nd exponent 3rd multiplication division 4th addition subtraction 7 To edit the sample type select the options button lt V gt beside Sample Type 1 1 or Sample Type 2 2 to select the sample types NOTICE The same sample type cannot be defined for Sample Type 1 1 and Sample Type 2 2 The default for Sample Type 1 1 is the default sample type specified in System Setup Refer to Default Setup Setting the Default Sample Type in this chapter The default sample type for Sample Type 2 2 is None 1 of 2 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 35 Calculations Setup Deleting Custom Calculations Step Action continued 8 Select to Save Calc F2 save the calculation defined Calc Summary F1 return to the Calculations Summary screen Prev Calc F9 return to the previous calculation if more than one Custom Calculation is chosen Next Calc F10 advance to the next calculation if more than one Custom Calculation 1s chosen Select any icon from the menu bar to exit 2 of 2 Deleting Custom Calculations The instrument status must be in Standby in order to proceed with the steps below to delete a Custom Calculation
316. ndard Dilutions as Default for Each Chemistry Selecting a Non Standard Dilution Default Cancel Select a Non Standard Dilution E011416S EPS o Figure 5 16 Non Standard Dilutions Display IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 41 Configuring Antigen Excess Testing Introduction Configuring Antigen Excess Testing Introduction Antigen excess AGXS testing can be enabled or disabled for each appropriate chemistry configured on the chemistry menu The default for AGXS testing is enabled for all the appropriate chemistries If AGXS testing is enabled AGXS testing is always performed for the associated chemistry If AGXS testing is disabled AGXS testing will not be performed for the associated chemistry AGXS can be enabled or disabled for an individual sample in Sample Programming How to Configure AGXS Testing The instrument status must be in Standby in order to proceed with the steps below to configure AGXS testing Step Action 1 From the Setup screen select lt 8 gt Antigen Excess A multipage list of chemistries will be displayed Refer to Figure 5 17 A checkmark in the box indicates AGXS is enabled for that chemistry Select the check box to remove the check and disable the AGXS testing Nain 66 27 1996 89 15 Becan J KJ Be Pme Samples Results Rats Cal Setup utiis Status STOP Antigen Excess Chen AGXS Testing Chen fiGXS Testin
317. ne eaa ctae eas e RR Ree thee deas vens 8 8 Recalling Results by Run Date Time ao eee etos eene otto ies ket ene een grades ee AN Uno cies 8 9 Displaying Recalled Results on the Screen sseeeeeeeeeenee eene 8 11 Printings Recalled RES IN 8 12 Sendi g Results tothe Host esent AER 8 13 IMMAGE 800 Operations Manual A11403 Results Recall March 2004 Page 8 1 Overview Introduction Results Recall Overview Introduction This chapter discusses how to recall and print patient and control results Results can be recalled by sample ID rack and position patient ID or run date and time Results which have been recalled can be sent to a host computer Up to 10 000 patient samples may be stored by the IMMAGE 800 database Results Recall IMMAGE 800 Operations Manual A11403 Page 8 2 March 2004 Recalling Results by Sample ID Introduction Recalling Results by Sample ID Introduction Results can be recalled by Sample ID and or a range of Sample IDs Recalling by Sample ID Follow the steps below to enter Sample IDs for recall Both individual Sample IDs and a range of Sample IDs can be entered Step Action 1 Select Results from the menu bar Refer to Figure 8 1 2 To enter type an individual Sample ID the Sample IDs desired for recall in the or a series of Sample Sample ID s field up to 42 characters IDs spaces are not allowed A single Sample ID has a maximum of 15 chara
318. ng differentiates these two situations Refer to Figure 3 7 A011361L EPS Increasing antigen concentration 3 Antibody excess AbXS X Y Rate response 4 Antigen excess AgXS 1 2 Figure 3 7 Antigen Excess Detection IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 9 Antigen Excess Testing How Antigen Excess Testing is Performed How Antigen Excess Testing is Performed The system performs antigen excess testing by adding additional antigen to the completed reaction Table 3 1 Antigen Excess Testing If unbound Ab is the addition of more Ag will and the IMMAGE 800 will result in present an increase in rate response as use the initial rate response to indicated by the solid line in calculate the final result Figure 3 8 not present no increase in rate response automatically rerun the as indicated by the broken line sample at the next higher in Figure 3 8 dilution and test for antigen excess until a final result is obtained 1 X Reaction time in seconds 2 Y Rate response Figure 3 8 A011362L EPS 3 Response if antibody excess 4 Response if antigen excess Rate Response versus Reaction Time Theory of Operations Page 3 10 IMMAGE 800 Operations Manual A11403 March 2004 Out of range Testing Description of Out of range Testing Out of range Testing Description of Out of range Testing The IMMAGE 800 re
319. ng the event option number Refer to Date Time option instructions 1 of 2 Utilities Page 10 44 IMMAGE 800 Operations Manual A11403 March 2004 Event Log Information Options Step Action continued 3 Select the desired option number s OR Type the option number s in the Option No field and press Enter Numbers can be separated by a comma as a series and or by a dash as a range Example 2 3 5 9 17 2 of 2 66 19 1998 09 36 Status Stop F12 11 Calibrate Touch Screen al Event Log 12 Shutdoun La Diagnostics a Alignment _5 Format QNX Diskettes 21 Backup Restore Wash Cuvettes gren Fill Internal Wash Bottle g Stop Print 18 Reload DAS Code E014070S EPS Figure 10 18 Utilities Dialog Box Information Options After the Event Log Option s has been selected the information can be formatted using the following options Refer to Table 10 9 and Table 10 10 Table 10 9 Event Log Options Option Description Display events F1 For reviewing events on the screen Copy to Disk F2 For saving events to a disk for permanent records Date Time F3 For selecting events for a specified date and time Clear events F4 For removing unwanted event information Print F10 For creating a paper copy To save paper before selecting Print verify only the desired event option s for the appropriate time period selected IMMAGE
320. ns Manual A11403 Page 3 4 March 2004 Signal Measurement and Reaction Dynamics Protein Rate Response Curve Protein Rate Response Curve Figure 3 4 illustrates the rate response for several test samples with various antigen concentrations The antibody is maintained at a constant level The magnitude of the rate response increases from test sample A to test sample F The rate response for test sample G is less than for sample F although the antigen concentration in sample G is greater than sample F Test sample H illustrates a further reduction in the rate response due to the increase in antigen concentration in the sample A011358L EPS 1 X Increasing Antigen Concentration Y Peak rate of scatter A H represent peak response values at varying antigen concentrations The antibody is maintained at a constant level oN Figure 3 4 Protein Rate Response Curve IMMAGE 800 Operations Manual A11403 Theory of Operations March 2004 Page 3 5 Signal Measurement and Reaction Dynamics Dynamics of Inhibition of Immunoprecipitin by Hapten Drug Dynamics of Inhibition of Immunoprecipitin by Hapten Drug In the drug assays the conjugate is prepared by linking several hapten drug residues to a high molecular weight carrier The conjugate competes with the free drug hapten in the sample for available binding sites on the antibody Increased drug in the sample results in a decrease in the formation of insoluble complexes Figure 3 5
321. nses them into the dilution well Aspirates diluted sample from the dilution well and dispenses it into a cuvette on the reaction wheel Sample Paddle Mixer Mixes the contents of a cuvette while diluted sample is dispensed Also mixes in dilution wells 2 Sample Syringe Pump Mechanism for accurate sample diluent and 250 uL diluted sample aspiration and delivery through the sample probe 3 Sample Crane Wash _ Washes interior and exterior of sample probe Station mixer 4 Sample Addition Two openings in reaction module cover to allow Ports samples to be added to one of two different cuvette locations IMMAGE 800 Operations Manual A11403 March 2004 System Description Page 2 13 Upper Instrument Subsystems Upper Subsystem List Upper Instrument Subsystems Upper Subsystem List The upper portion of the instrument contains three subsystems Hydro Pneumatics Electronics Control Compartment Power Supply Assembly Hydro Pneumatics The hydro pneumatics control the flow of wash solution through the system and the flow of waste out of the system Pressure and vacuum control this fluid motion Refer to Figure 2 8 1 Pressure Reservoir Liquid 2 Pressure Reservoir Air 3 Vacuum Reservoir Figure 2 8 Hydro Pneumatics System Description IMMAGE 800 Operations Manual A11403 Page 2 14 March 2004 Upper Instrument Subsystems Electronics Compartment Electronics Compartment The electronics
322. nt Wash solution box placement Waste container placement System Setup IMMAGE 800 Operations Manual A11403 Page 5 118 March 2004 Placing Labels on a Rack Introduction Placing Labels on a Rack Introduction Two labels must be placed on each rack The labels identify the rack number One label is bar coded the other label is a numbered label Placing the Bar Coded Label on the Rack Place the bar coded rack label on the side of the rack as pictured in Figure 5 58 A010084P EPS Rack bar code label Figure 5 58 Rack Bar Code Label Placement IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 119 Placing Labels on a Rack Placing the Rack Number Label on the Rack Placing the Rack Number Label on the Rack Place the rack number label on the top of the rack as pictured in Figure 5 59 A010085P EPS Rack number label Figure 5 59 Rack Number Label Placement System Setup IMMAGE 800 Operations Manual A11403 Page 5 120 March 2004 Wash Solution Box and Waste Container Placement Introduction Wash Solution Box and Waste Container Placement Introduction The wash solution box and waste container are placed by the instrument in specific locations Wash Solution Box Placement The wash solution box is placed close enough to the instrument to allow connection of the wash solution tube Waste Container Placement The waste container must be placed with the opening of the waste cont
323. nt Summary Di luent a aquest Cards F1 F2 F3 ES F5 F6 E F8 Select an option E011425S EPS Figure 6 8 Reagent Status Calibration Status Screen Verifying the Cal Status of Reagent Parameters in the Database Follow the steps below to verify the calibration status of any reagent loaded in the database Step Action 1 From the Reagent Status Calibration Status screen select Reagent Summary F2 Refer to Figure 6 9 2 Verify the calibration status under the Cal Status heading for the desired reagent 3 For further information about the reagent complete the following steps From the Reagent Summary dialog box select a button beside a desired reagent THEN Select the lt Display gt button to view the reagent lot parameters Refer to Figure 6 4 OR Select lt Go To gt and type the Chem and Lot number 4 Select lt OK gt from the Reagent Lot Parameters dialog box when finished viewing the reagent lot parameters IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 19 Checking Calibration Status Verifying the Cal Status of Reagent Parameters in the Database E E z E E gH m E M512146 M411105 W511179 M6821681 M511203 M581195 W511284 M4liBi8 M587182 W511205 Belete Figure 6 9 93 01 1998 12 01 1996 63 61 1998 61 61 2606 61 61 2080 81 01 1998 61 61 1998 11 61 1996 11 61 1996 11 81 1996 Cal Status Cal Date Uncalibrated Unc
324. nt ID ici a a a a 7 10 7 24 Requesting by sample ID 7 72 Pausing to load samples s sss 7 58 Loading a new lot or changing a position Peltier uris eee ged gasp ATE Is 2 5 Buffer diluent oooooocococcooooo oo 6 10 Pending 2 ta ad af cet as RU 7 70 Loading rack cece eee 2 20 Placement sexu a ume ee ee 2 46 Loading reagent cartridges on the reagent carousel 6 15 Placing a tube into arack 055 2 52 Loading reagent calibrator bar code cards on a rack 6 6 Port Connections Loading samples 0 000 e eee eee ee eee 7 51 CPU ports ssc ei ee ee dae de eee 2 24 Loading the wash soluti0N 6 13 Power off sequence 0s eee eee aes 4 4 Lot numbers cocacola de eee ed 9 6 Power on sequence 00 eee eee eee 4 2 Power requirements 0000 eee eae 2 46 Power supply assembly 2 14 2 16 M Precautions Antistatic wrist strap o oooooooooo 10 5 Manual conventions Biological hazards llle 10 5 Buttoris orici pi UPRER CREEDuG4 1 3 Circuit Doard cunc eene ER d 10 5 Combination keys 0 0000 eee eee 1 3 PRECISION oce Drop andere but eR ar d 9 4 9 22 Function buttons lille 1 3 Pre run checklist 0 0 00 ee eee eee 7 54 Icon buttons ee ee ee 1 3 Pressulre z cuis le Ape ek Bes oe eae 2 14 Keyboard keys 1 3 Primary tubes 2 49 Options button 0 00 c ee
325. nt Name can only be accessed through Demographics Middle Lower chemistry menu Allows the selection of panel numbers and or chemistry numbers Displays the chemistries which were configured in Setup Allows the selection of chemistries ndicates that antigen excess testing is enabled for a chemistry by displaying a small green box e Displays Page Up and Page Down buttons so chemistries with numbers greater than 45 can be accessed Sample Programming Page 7 12 IMMAGE 800 Operations Manual A11403 March 2004 Program Sample Screen 7 Program Sample Function Buttons Program Sample Function Buttons The following table describes the function buttons at the bottom of the screen Table 7 3 Program Sample Function Buttons Name Button Description Demog F2 Allows the entry of patient demographic information Sample Options F3 Allows the selection of sample or chemistry replicates off line or non standard dilutions antigen excess testing and linking samples Program Batch F4 Allows a sample program to be automatically repeated for multiple samples Program Control F5 Allows the selection of a control from a pre defined list Rerun Samples F6 Allows the selection of samples or chemistries to be rerun Clear Samples F7 Allows sample programs or racks to be cleared Post Run Summary F8 Provides a list of pending or incomplete samp
326. nt the final calculation on reports when the chemistries necessary for the calculation are run The system provides a maximum of 28 additional calculations that may be defined edited and or deleted by the operator The Custom Calculations feature provides for the reporting of operator defined calculations using sample results when chemistries necessary for the calculations are run The calculations may involve results from one sample or two linked samples The default for calculations is disabled Calculation Description The following table describes the 12 calculations available on the IMMAGE 800 Table 5 3 Calculations Available on IMMAGE 800 Calculation Chemistries Run for Formula Name Calculation APA APB Apolipoprotein A serum APA serum APB Apolipoprotein B APB APA Apolipoprotein B serum APB serum APA Apolipoprotein A KAP LAM Kappa Lambda serum KAP serum LAM PRO NAPA Procainamide serum PRO serum NAPA N acetylprocainamide PRI PHE Primidone serum PRI serum PHE Phenobarbital Excretion Rate Any urine chemistry that Result in mg dL 10 is configured Volume in mL Time in minutes serum and CSF Albumin serum and CSF CSF Index Immunoglobulin G CSF IGG serum ALB CSF ALB CSF and serum serum IGG Albumin CSF and serum IGG Synth Rate Immunoglobulin G 5 dL day CSF IGG serum IGG 369 CSF ALB serum ALB 230 0 43 serum IGG serum ALB
327. nts If Then a cartridge is designated by a reagent parameter bar code is loaded on the carousel with a predetermined number of tests remaining has a chemistry requested for calibration it may be used to establish a cartridge specific calibration a calibration is requested the status of only the cartridge designated for cartridge specific calibration changes to Requested All other cartridges of that chemistry maintain the same calibration status prior to the request additional cartridges of the same lot with greater than the predetermined number of remaining tests are loaded on the system the calibration is successfully completed those cartridges maintain the reagent lot calibration the Cal Status of that cartridge goes to Calibrated e a new cartridge specific calibration is applied the reagent lot calibration is no longer associated with this cartridge the cartridge specific calibration does not affect any other cartridge with the same lot number the calibration fails the status of only the Requested cartridge changes to Cal Failed The Cal Status of all additional cartridges will not change cancellation of the cartridge specific calibration request is desired cancel the calibration request Refer to Requesting and Canceling Calibration in this chapter reestablishment of cartridge specific calibration is desired reenable
328. nu bar 2 To select comment from list To enter comment number Select the options button lt W gt Choose the Sample Comment beside the Sample Comment field field AND AND Type the number of the desired Type the number of the desired comment and press Enter comment and press Enter OR Select the number beside the desired comment Sample Comment No 1 henoLyzeo 2__ LIPEMIC 3 ICTERIC aa 141 18 Cancel E010255S EPS Figure 7 5 Sample Comment Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 22 March 2004 Entering a Comment Entering a Sample Comment Entering a Comment Follow the steps below to enter a Sample Comment Step 1 Action Select Samples from the menu bar 2 Choose the Sample Comment field 3 Type a Sample Comment up to 25 alphanumeric characters Additional Information Refer to CHAPTER 5 System Setup Sample Comments Setup for more information on defining a list of Sample Comments IMMAGE 800 Operations Manual A11403 March 2004 Sample Programming Page 7 23 Entering a Patient ID Introduction Entering a Patient ID Introduction A Patient ID can be entered in the Patient ID field The Patient ID can be used as a link to recall demographics refer to Table 7 4 Table 7 4 Patient ID Field If and then a Patient ID is entered along the same Pa
329. nvalid rack ID detected O0 mpenim src wlm wlm_verify c 84 a 8 a 3 a 8 8 8 8 8 8 8 a 1 B 8 4 E OEO 5 o E010317L EPS Figure C 22 Event Error Log IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 23 Introduction User Defined Single Point Calibration Results User Defined Single Point Calibration Results IMMAGE S N 1458 01 29 2004 14 42 58 PAGE 1 BECKMAN COULTER INC 200 S Kraemer Blvd Brea CA 92822 S N 1458 Software 2 0 03 USER DEFINED SINGLE POINT CALIBRATION RESULTS CHEM UDRS REAGENT CARTRIDGE S N CB23 UDR BUFFER BUF T211272 REAGENT LOT M303185 UDR DILUENT DIL1 T307087 REAGENT CARTRIDGE LOT M302304 UNIT UDRMCAL 4 1 x mg dL UDRMCAL4 2 mg dl MEAN 88 44 SD 0 4172 SCV 0 4718 E011443L EPS Figure C 23 User Defined Single Point Calibration Results Reports IMMAGE 800 Operations Manual A11403 March 2004 Page C 24 Introduction User Defined Single Point Calibration Update Report User Defined Single Point Calibration Update Report IMMAGE S N 1458 CHEM RGT POS RACK POS UDR3 01 29 2004 15 12 23 PAGE 1 BECKMAN COULTER INC 200 S Kraemer Blvd Brea CA 92822 S N 1458 Software 2 0 03 USER DEFINED SINGLE POINT CALIBRATION UPDATE REPORT REAGENT CARTRIDGE S N C823 UDR BUFFER BUF1 T211272 REAGENT LOT M303185 UDR DILUENT DILI T307087 REAGENT CARTRIDGE LOT M3G2304 MEAN INST CAL ID RESP UBRMCAL4 2 88 44 CAL
330. o ooo 3 12 Calibrator target value o oooo ooooo 3 12 Theoretical response 20 000 3 12 System pause ees 7 57 Index Page vi of vii IMMAGE 800 Operations Manual A11403 March 2004 System replicates oooooooooooooo 7 29 T Reagent summary dialog box 6 20 W Tab spacebar 0 cece eee 2 35 Warranty policy 1 5 Temperature and humidity 2 46 Wash cuvettes 0 0 0 e eee eee ee 10 18 Temperature warning note 055 4 2 Wash head 0 0 eee eae 10 53 10 63 Test replicate 2 0 0 2 0 2 7 29 Wash solution 2 17 2 18 6 13 10 8 10 67 Test replicateS 7 10 7 29 7 65 Wash solution box placement 2 18 5 118 Toxic a adn 2 30 Wash solution tubing ooooooooo 2 17 Three pronged power plugs 1 7 Wash station 0 0 eee ooo 2 7 2 13 TITIO itur hti eR PREISE ERO RR ARA 5 46 Washing CUVetteS oo ooooooooomoo 10 20 Formatting aei ri 5 46 Waste COntaiNer ooooo 2 17 10 8 Timed urine parameters Waste container placement 2 18 5 118 Sample type 0 0 0 cee eee eee 7 21 Waste tubing 0 cee eee eee 2 17 Timed urine parameters dialog box 7 21 Weight reed em dme ute 2 46 Til Dario cn uei oe oe Sada e ca Eee 2 28 WellS 5 1 rui ridad apace chun ep 2 11 2 12 Togg
331. o the Setup dialog box without restoring the defaults IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 59 Sample Comments Setup Introduction Sample Comments Setup Introduction Up to 20 sample comments may be predefined on the IMMAGE 800 Immunochemistry System for use when programming samples on the instrument These will be presented in a numbered menu when programming samples Defining New Sample Comment The instrument status must be in Standby in order to proceed with the steps below to define samples comments Step Action 1 From the Setup screen select lt 12 gt Sample Comments Refer to Figure 5 23 2 Choose a text field beside a comment number Type a comment up to 25 characters long including spaces and punctuation 4 Return to Step 2 for additional comments Samples Results Status Sample Comments HEMOLYZED LIPEMIC ICTERIC El 2 3 4 5 5 7 8 9 18 Print Eig Enter Sample Comment E010229S EPS Figure 5 23 Sample Comments Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5 60 March 2004 Sample Comments Setup Editing a Sample Comment Editing a Sample Comment The instrument status must be in Standby in order to proceed with the steps below to edit a sample comment Step Action 1 From the Setup screen select lt 12 gt Sample Comments Refer to Figure 5 23 2 Choose the comment to be edited Edit th
332. ocedure tables are the most common type of table in this manual They list each step of a procedure by number with the corresponding action that is to be performed A Refer to Figure x x instruction directs the operator to the screen that displays as a result of the action requested in the step Occasionally a decision must be made at a step within a procedure A smaller decision table is then presented which describes the variable conditions in the left column and the appropriate action for each condition in the right column Example of Procedure Table The following table is an example of a procedure table that contains a decision table Step Action 1 Select Rerun Samples F6 Refer to Figure x x 2 To enter type individual Sample IDs the Sample IDs for rerun in the Sample IDs field a range of Sample IDs the Sample ID at the beginning of the range in the Range field 3 Select a button from the bottom of the dialog box Read the decision table as complete sentences using the first heading to introduce the condition and the second heading to introduce the action Step 2 of the table is read To enter individual Sample IDs type the Sample IDs for rerun in the Sample IDs field To enter a range of Sample IDs type the Sample ID at the beginning of the range in the Range field General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 4 March 2
333. og box is displayed Refer to Figure 5 15 and Table 5 4 The default units are displayed in the Units Conversion dialog box Follow the steps below to enter a conversion factor Type the conversion factor to be multiplied by the default units in the Conversion factor field e Select OK to save the conversion factor OR Select Cancel to return to the Units dialog box without saving the conversion factor Repeat Steps 2 4 for additional chemistries IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 37 Units Setup Selecting Units for Each Chemistry Standby Select a Sample Type Figure 5 13 Units Non Standard Dilutions Screen Select Unit Selected 8 mg m 15 nmol L _22 oium B ug ml 16 pmol L 23 un 18 ng mL 17 IU L 24 Usd 14 pgm 18 mua _25 um 12 noi _49 uu 13 mmol L _20 IU mL 14 unt 21 mun Cancel E010221S EPS Figure 5 14 Units Dialog Box Enter Conversion Factor IGG From default To selected Conversion factor gt E010220S EPS Figure 5 15 Units Conversion Dialog Box E011415S EPS System Setup Page 5 38 IMMAGE 800 Operations Manual A11403 March 2004 Table 5 4 Units Categories Units Setup Restoring Defaults Weight Volume Mass Volume International Units Volume Units Volume g L mol L IU L U L mg L mmol L mIU L U dL g dL umol L
334. ompartment B Volume 0 or from Reagent volume aspirated from Refer to Figure 5 34 5 uL to 235 uL cartridge compartment B Gain 1 2 3 4 Signal amplification As gain number increases signal amplification increases Cal Dilution 1 1 or 1 5 to 1 50 Determines dilution ratio for calibration Sample Dilution 1 1 or 1 5 to 1 50 Determines dilution ratio for sample predilution Reaction Time Select from list 1 5 to 10 minutes Interval in which reaction readings are taken after addition of the last reagent to the reaction mixture System Setup Page 5 76 IMMAGE 800 Operations Manual A11403 March 2004 Defining a UDR Chemistry Description of Definition Fields A011410P EPS 1 Reagent Compartment Cover 5 Reagent Bar Code Reader 2 Reagent Carousel 6 Fans 3 Reaction Buffer Bottle 7 Temperature Sensor 4 Reagent Cartridges Compartments A and B Figure 5 34 The Reagent Compartment The following table describes the calibration fields of the Define Edit User Defined Chemistry screen Page 3 Refer to Figure 5 35 Table 5 9 Calibration Definition Fields Page 3 Field Entries Allowed Function Levels 4 to 9 Identifies the number of calibrators used in test Replicates to 9 Allows a number of tests to be repeated for each calibration level Update Level 1to9 Single point calibration setpoint update level Replicates to 9 Set point upda
335. ompletion of the daily workload Step Action 1 Open the reagent compartment cover 2 Lift the reagent carousel from the center and remove 3 Store the loaded reagent carousel in the refrigerator No software intervention is required Removing Cartridges from the Reagent Carousel The instrument status must be in Standby in order to proceed with the steps below to remove reagent cartridges from the reagent carousel Step Action 1 Open the reagent compartment cover 2 Lift the reagent cartridge up from the reagent carousel 3 Store the cartridge in the refrigerator No software intervention is required 4 Close the reagent compartment cover Reagents Calibration Page 6 16 IMMAGE 800 Operations Manual A11403 March 2004 Overview Introduction Calibration Overview Introduction This section explains the following topics Checking Calibration Status Requesting and Canceling Calibration Loading Calibrators on the Sample Carousel Starting a Calibration Run Calibration Results Re enabling Calibration Cal Options IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 17 Checking Calibration Status Introduction Checking Calibration Status Introduction The calibration status of each chemistry can be checked prior to performing a run Explanation of Terms The following table explains the different calibration status terms
336. on 1 Select Date Time F3 from the Event Log Screen 2 Type in desired time period Press the Enter key to advance the cursor to each field 3 Select lt OK gt to return to the Event Log Screen Select Display Events F1 to view events that occurred during the selected time period Refer to Figure 10 21 OR Select lt Cancel gt to exit the Date Time screen without specifying a date time period E010296S EPS Figure 10 21 Date Time Dialog Box Utilities IMMAGE 800 Operations Manual A11403 Page 10 48 March 2004 Event Log Clearing Events Clearing Events After selecting the desired event log follow the steps below to clear the desired events Step Action 1 Select Clear Events F4 from the Event Log Screen 2 Verify events to be cleared 3 Select lt OK gt to remove specified events OR Select lt Cancel gt to exit the Clear Events screen without clearing events Printing an Event Log Follow the steps below to print an Event Log Step Action 1 Select a desired event from the Event Log Screen 2 Select Display Events F1 3 Select lt Print gt IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 49 Callable Diagnostics Introduction Callable Diagnostics Introduction The Callable Diagnostics option provides procedures directed toward identifying and isolating specific IMMAGE 800 malfunctions This section describes
337. on a calibrated or uncalibrated UDR Programming Rate Mode The instrument status must be in Standby in order to proceed with the steps below to program a UDR for rate mode Step Action 1 From the User Defined Chemistry screen select Rate Mode F3 Refer to Figure 5 39 2 Select up to six of the UDR chemistries 3 Select lt OK gt to continue Rate Mode may be run on a calibrated or uncalibrated UDR NOTICE Rate results are always uncalibrated rate whether the UDR is calibrated or uncalibrated OR Select lt Cancel gt to exit rate mode and return to the User Defined Chemistry screen 4 From the UDR Rate Mode Assign screen Refer to Figure 5 40 enter an available rack number in the Rack field OR Select Clear Racks F1 and Enter the racks and or positions to clear Select lt OK gt to clear or lt Cancel gt to exit without clearing 5 Enter a position number in the Pos field Up to nine positions may be entered 6 Enter a Sample ID in the Sample ID field for each position assigned Up to 15 characters may be entered 7 Select Save F9 to save the program OR Select Cancel F10 to exit the screen without saving the program Repeat Steps 1 7 to program additional racks for rate mode 9 Print a Load List from Sample Programming 1 of 2 IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 93 Programming Rate Mode Programming Rate Mode
338. onal Host Up IMMAGE 800 host communications is set for transfer of data from the IMMAGE 800 to the host only Bidirectional Bidirectional with Host Query Host Up IMMAGE 800 is able to communicate with the host Host Down Host Up IMMAGE 800 is unable to communicate with the host but is still trying IMMAGE 800 is able to communicate with the host Host Down IMMAGE 800 is unable to communicate with the host but is still trying Host Up Query in Progress IMMAGE 800 is querying for samples from the host Host Down Query in Progress IMMAGE 800 is unable to communicate but is still attempting to query for samples from the host Checking for a Successful Host Query For the Bidirectional and Bidirectional With Host Query setups review the load list for any samples that have not been received from the host after the run is in progress Sample Programming Page 7 84 IMMAGE 800 Operations Manual A11403 March 2004 per 7 Operating IMMAGE 800 in Japanese Overview Introduction There are several features available when the IMMAGE 800 is enabled in the Japanese language These features are Keyboard entry mode selection in English or Japanese Romaji by use of a Japanese keyboard Data entry and edit in English Hiragana Katakana and Kanji within some functions e Static and dynamic display of Japanese characters on screens and fields that
339. ons Manual A11403 Utilities March 2004 Page 10 43 Event Log Introduction Event Log Introduction The Event Log is a record of system events such as an error or system status information that is logged e g The time has changed This logged information can be used as a troubleshooting tool if a problem is encountered while operating the instrument Event Information The following information displays as part of the event log description Table 10 8 Event Log Event Information Definition Number Sequential number identifying the order with number one representing the most recent event Class Number corresponding to the 1 25 event classes listed on the event log main screen e g Input Device Events Date Event searches specified for the appropriate Month Day and Year Time Event searches specified for the appropriate Hours and Minutes Description Identifies previous condition of the event logged Accessing the Event Log The instrument status must be in Standby in order to proceed with the steps below to access the Event Log Step Action 1 Select Utilities from the menu bar Refer to Figure 10 18 Numbers 2 Select 2 Event Log Refer to Table 10 9 for a list of the Option OR Enter 2 in the Option No field and press Enter NOTICE It may be useful to select a specific time period for retrieval This may be done before or after selecti
340. ons use the test results from two different samples The Sample IDs of both samples must be linked so the calculation can be performed Samples can also be unlinked Linking Samples Follow the steps below from the Sample Program screen to link two samples Step Action 1 Program one of the samples to be linked Select Save Next F10 2 Enter a Sample ID select chemistries and program any additional information for the other sample to be linked Select Sample Options F3 4 Select lt Link Samples gt Refer to Figure 7 9 Type the Sample ID of the saved sample to be linked to the sample being programmed 6 Select lt OK gt to save the link and return to the Sample Options dialog box OR Select lt Cancel gt to return to the Sample Options dialog box without linking the samples Link Samples Sample ID P Link diste c Az ID Uni ink OK Cancel Samples E us E010298S EPS Figure 7 9 Link Samples Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 35 Linking Unlinking Samples Unlinking Samples Unlinking Samples Follow the steps below to unlink two samples Step Action 1 Display one of the linked samples by entering the Sample ID in the Program Sample screen Select Sample Options F3 Select lt Link Samples gt Select lt Unlink Samples gt NM BB Ww vy Select lt OK gt to unlink the samples
341. ooooo 9 19 Copy to diskette dialog bOX 10 48 Deleting from quality control screen COVES esto coh Rose Sat ER TANE 1 7 Delete control 020 eee eee eee 9 18 CPU osc bic ine ate nce ELM SR E UTOR 4 2 Deleting from review control screen ECL TM MH n 1 7 Delete control 00 cece eee 9 18 CUISOfe da ui ar ate cedere ie bs 2 30 Review control 0 2002 eee eee eee 9 18 Curve fit model anaana eile 5 103 Deleting panels 00002 5 12 Descriptions llle 5 103 Deleting reagent parameters 6 8 First order polynomial 5 103 Delete reagent lot confirmation dialog box 6 8 Four parameter logistic 5 103 Demographics Second order polynomial 5 103 AO a wae 7 26 Third order polynomial 5 103 Age US ici ad 7 26 Custom calculati0N ooooococooooo 5 34 Collected by ooocoooocccoocc eee 7 27 Defining cep tt GRADES 5 34 Collection date 0 0 cee eee 7 27 Deleting rroi eres era cio 5 36 Collection time 0 0 0 0 eee eee eee 7 27 Editing ies Sates Gee hed eee eR 5 35 Date of birth llle 7 26 Cuvette wash 0 0 eese ee 10 14 Demographic field entries 7 26 Cuvette wash station 0000 esee 2 9 Doctora het diia ACIE 7 27 CuvettesS oooo 2 9 10 14 10 17 10 18 Location 3 ment gos re REOR caca Toe eR 7 27 Cycle count sec
342. or a description of switches and port connections Refer to CHAPTER 2 System Description Computer Printer for the location of appropriate switches and connections Refer to the instruction manual provided with the UPS for specific information on the UPS IMMAGE 800 Operations Manual A11403 System Power On Off March 2004 Page 4 3 System Power Off Introduction System Power Off Introduction It is recommended that the instrument remains powered on and in Standby when not in use Powering off the system is recommended for the following situations when parts replacement procedures specify power to be turned off when moving the system to a new location when lab power goes off the console is protected by the UPS Once the procedure is complete or lab power is restored power on the system Power Off Sequence The instrument status must be in Standby in order to proceed with the steps below to power off the IMMAGE 800 system NOTICE The database may become corrupted if power is turned off before the Power Off sequence is completed Step Action 1 Check that the floppy diskette drive is empty 2 Select Utilities from the menu bar 3 Select lt Shutdown gt 4 When the message Shutdown Complete is displayed turn off the printer monitor CPU computer UPS and instrument Emergency Stop Turn the instrument main power switch off if the stop button on the screen is
343. ore Replicates for Calculation Only one Replicate Calculation E72 NoParam No Valid Reagent Reread reagent card Parameters A G Reagent Card with no Parameters or Bad Read E73 RGT Handler Reagent Handler Error CALL BECKMAN COULTER CLINICAL SUPPORT E76 Loop Error Out of range result failed Rerun pending test to reach final dilution level E77 DilWell LVL Level sense failure ona Rerun sample dilution well E79 S W Error No memory available Reboot Instrument E80 Bad Data Bad Data CALL BECKMAN COULTER CLINICAL SUPPORT 6 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 28 March 2004 Table 10 7 Displayed or Printed Error Messages continued Errors Error Table Error Abbreviation Explanation Action Message E81 Bad Data Bounds Failure CALL BECKMAN COULTER CLINICAL SUPPORT E82 Bad Data Divide by Zero CALL BECKMAN COULTER CLINICAL SUPPORT E83 Bad Data Excessive Q Values CALL BECKMAN COULTER CLINICAL SUPPORT E84 Bad Data Log 10 Domain Error CALL BECKMAN COULTER CLINICAL SUPPORT E85 Bad Data Divide by Zero Error CALL BECKMAN COULTER Cal Actual Actual CLINICAL SUPPORT Zero 101 Queue Send FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 102 Queue Receive FATAL CALL BECKMAN COULTER Error CLINICAL SUPPORT 103 Event Send Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 104 Event Receive FATAL CALL BECKMAN COULTER
344. ore the defaults OR Select lt Cancel gt to return to the Host Communications Parameters screen without restoring the defaults Table 5 6 Host Communication Parameter Defaults Parameter Default Sender ID blank Baud Rate 9600 Stop Bits 1 Parity None Data Bits 8 Timeout Value 1 minute Auto Send Results Enabled Error Display Mode Enabled Continuous Numbering Mode Enabled Operational Mode None Request Information Mode Single Message Header Mode Abbreviated Header Additional Information For additional information refer to IMMAGE Immunochemistry Systems Host Interface Specifications System Setup Page 5 56 IMMAGE 800 Operations Manual A11403 March 2004 Default Setup Introduction Default Setup Introduction Default Setup is used to define the default sample type for all samples programmed The sample type can be changed for individual samples from the Program Sample screen define the default number of replicates to be run for each sample and what statistics to run on replicates enable or disable statistics to run on replicates define the default setup of the Calibration Halt function Setting the Default Sample Type The instrument status must be in Standby in order to proceed with the steps below to define default sample types Step Action 1 From the Setup screen select lt 11 gt Default Setup Refer to Fig
345. ot 1 Clear dilution segments Defined or Cleared 2 Rerun sample E47 S W Error Scheduling Failed CALL BECKMAN COULTER CLINICAL SUPPORT E48 No Param No Valid Reagent 1 Reload reagent card Parameters A G 2 Reload reagent E49 Buff N A Insufficient Buffer Load a new buffer bottle and verify that buffer position is defined correctly 50 Process FATAL CALL BECKMAN COULTER Exception CLINICAL SUPPORT 4 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 26 March 2004 Table 10 7 Errors Error Table Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message ESO Dil N A Insufficient Diluent Load a new diluent bottle and verify that diluent position is defined correctly E51 Sample N A Insufficient Sample Verify sufficent sample E52 CalFail Calibration Failure Repeat calibration E53 Pause Pause CALL BECKMAN COULTER CLINICAL SUPPORT E54 RGT Handler Reagent Handler Error CALL BECKMAN COULTER CLINICAL SUPPORT E55 WASH N A Insufficient Wash Fluid 1 Verify wash line is not pinched 2 From Utilities menu select 8 Fill Internal Wash Bottle 3 Rerun samples E56 No Model No Model CALL BECKMAN COULTER CLINICAL SUPPORT E57 RXN Temp Reaction Temperature 1 Verify cover is in place Out of Range 2 Check Status Monitor for stable temperature E58 ORLO Low Result Refer to IMMAGE Immunochemistry Systems Che
346. ouch screen Using the Mouse The mouse is the recommended method for performing actions with the IMMAGE 800 When the mouse is moved the arrow on the screen moves with it This arrow is called the pointer Movements of the pointer correspond to movements of the mouse When the pointer tip is touching an item on the screen the pointer is pointing to that item Pressing the left button on the mouse and quickly releasing it is called clicking Clicking a button on the screen that the pointer is pointing to will select that button Clicking twice in rapid succession is called double clicking Pressing and holding down the left mouse button and moving the mouse is referred to as dragging Using Keyboard Equivalents All actions on the IMMAGE 800 can be performed with keyboard equivalents as well The screen navigation will be affected by the location of the cursor on the screen The cursor movement is directed either within a partition local movement which is a logical grouping of data fields that may or may not be visually distinct from other groupings or is directed globally which is movement throughout the entire screen Keyboard equivalent methods include Alt Key Function Buttons Tabs Spacebar Arrow Keys Spacebar Page Up Page Down Keys e Selecting a number from a list Alt Key Icon buttons on the menu bar at the top of the screen can be selected by pressing and holding down the Alt key and then pressin
347. ousel Up to 4 bottles of sample diluent may be placed on the inner section of the sample carousel For certain chemistries a buffer is used as sample diluent and is placed on the inner section of the sample carousel Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Only one lot number of each buffer type and one lot number of each diluent type may be loaded onto the system at one time Multiple bottles of the same lot can be loaded at different positions When multiple positions are defined for the same buffer or diluent the lot number will be automatically copied to each position Checking Buffer Diluent Status The instrument status must be in Standby in order to proceed with the steps below to check the buffer and diluent status before a run Step Action l Select Rgts Cal from the menu bar 2 Select Buffer Diluent F3 Refer to Figure 6 6 3 Check the Remaining for a sufficient amount to complete a run Approximately 350 tests per bottle of reaction buffer IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 9 Loading Clearing Buffers and Diluents Loading a New Lot or Changing a Position Buffer Diluent Status Figure 6 6 T511141 P2020296 1510169 Lot 1510168 1516168 1516168 1516168 Cancel E010234S EPS Buffer Diluent Status Dialog Box Loading a New Lot or Changing a Position The instrument st
348. ower Supply Out CALL BECKMAN COULTER of Range CLINICAL SUPPORT E23 N12V PS OR NI2V Power Supply Out CALL BECKMAN COULTER of Range CLINICAL SUPPORT 2 of 21 Utilities IMMAGE 800 Operations Manual A11403 Page 10 24 March 2004 Table 10 7 Errors Error Table Displayed or Printed Error Messages continued Error Abbreviation Explanation Action Message E24 P24VDPSOR P24VD Power Supply CALL BECKMAN COULTER Out of Range CLINICAL SUPPORT E25 P24VEPSOR P24VE Power Supply CALL BECKMAN COULTER Out of Range CLINICAL SUPPORT E26 P24VH PS P24VH Power Supply CALL BECKMAN COULTER Out of Range CLINICAL SUPPORT E27 P24VS PS P24VS Power Supply CALL BECKMAN COULTER Out of Range CLINICAL SUPPORT E28 P24VP PS P24VP Power Supply CALL BECKMAN COULTER Out of Range CLINICAL SUPPORT E29 Hi Press High Pressure Out of With system running samples Range 1 Check Status Monitor 2 Verify high pressure is in range E30 Lo Press Low Pressure Out of With system running samples Range 1 Check Status Monitor 2 Verify low pressure is in range E31 Vac Vacuum Out of Range With system running samples 1 Check Status Monitor 2 Verify vacuum is in range E32 RGT A LVL Level Sense Failure 1 Check and remove bubbles from Reagent Compartment A Reagent Compartment A 2 Rerun sample E33 RGT B LVL Level Sense Failure 1 Check and remove bubbles from Reagent Compartment B Reagent Compartment B 2 Rerun
349. p Defining Inter Lab Information Defining Inter Lab Information The instrument status must be in Standby in order to proceed with the steps below to define the Inter Lab information for the report header Step Action 1 From the Setup screen select lt 5 gt Report Setup Refer to Figure 5 9 2 Type the laboratory Inter Lab ID number beside the ID Number field up to 9 numbers The default is blank 3 Type the name of the attention person beside Attention Person field up to 30 alphanumeric characters The default is blank Restoring Report Setup Defaults The instrument status must be in Standby in order to proceed with the steps below to restore report setup defaults Step Action 1 From the Setup screen select lt 5 gt Report Setup Refer to Figure 5 9 2 Select Restore Default F1 to return all patient and control report setups to their defaults 3 Select OK at the confirmation screen to restore the defaults OR Select Cancel to return to the Report Setup screen without restoring the defaults Additional Information For examples of report formats refer to APPENDIX C Reports IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 27 Calculations Setup Introduction Calculations Setup Introduction There are 12 Beckman Coulter defined calculations that can be enabled for the IMMAGE 800 The system will automatically calculate and pri
350. pe 1 1 or Sample Type 2 2 to select the sample type s NOTICE The same sample type cannot be defined for Sample Type 1 1 and Sample Type 2 2 The default for Sample Type 1 1 is the default sample type specified in System Setup Refer to Default Setup Setting the Default Sample Type in this chapter The default sample type for Sample Type 2 2 is None Select Save Calc F2 To save the calculation defined Select Cale Summary F1 to return to the Calculation Summary screen OR Select any icon from the menu bar to exit System Setup Page 5 34 IMMAGE 800 Operations Manual A11403 March 2004 Calculations Setup Editing a Custom Calculation Editing a Custom Calculation The instrument status must be in Standby in order to proceed with the steps below to edit a Custom Calculation Step Action 1 From the Setup screen select 6 Calculations OR Enter 6 in the Option No field 2 Select the number s beside the Custom Calculations desired OR Enter the number s corresponding to the Custom Calculations in the Option No field Select View Edit F1 4 To edit the calculation name enter a name with a maximum of 15 characters and press Enter to continue 5 Select the check box next to Enable Calculation to enable or disable the use of the calculation and press Enter to continue 6 To edit the calculation formula enter a formula with a maximum total of six chemistries a
351. pe of serum or plasma If the sample type defined for a calculation is plasma the calculation is applied to samples with a sample type of serum or plasma Custom Calculations that require two samples must be linked through Sample ID Each sample can only be linked to one other sample Refer to CHAPTER 7 Sample Programming Linking Unlinking Samples Slope offset adjustments if used will be applied to the chemistry result before the calculation is performed Custom calculation results are reported without units IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 33 Calculations Setup Defining a Custom Calculation Defining a Custom Calculation The instrument status must be in Standby in order to proceed with the steps below to define a Custom Calculation Step Action 1 From the Setup screen select lt 6 gt Calculations OR Enter 6 in the Option No field Select Define Calc F3 Define the calculation name with a maximum of 15 characters Select the check box next to Enable Calculation to enable the use of the calculation Enter the calculation formula with a maximum total of six chemistries and or variables per calculation The order of precedence when using mathematical operations in a calculation formula are lst brackets 2nd exponent 3rd multiplication division 4th addition subtraction Select the options button lt W gt beside Sample Ty
352. ponding keyboard function key Options Button Within the working area and occasionally on screens or dialog boxes are buttons that perform a different function than the F numbered function buttons These buttons called options buttons appear triangular in shape V and often accompany a text field When an options button is selected it presents a list of items or options from which a user may choose Message Bar The blue bar at the bottom of the screen is the message bar This bar is used for instructions and error messages The first line displays instructions and the second line displays error messages These messages are related to activities in the working area Refer to Figure 2 18 System Description IMMAGE 800 Operations Manual A11403 Page 2 28 March 2004 Working Area Screen Format Working Area The middle portion of the screen is referred to as the working area The user enters data into the working area via Text fields Buttons Toggle buttons Check boxes Sampl Patient Rack Pos sra Eis 415 Sample Sample Patient 10 L 1 comment SE RN LZ RES ES zm Sample Progranm Select _ Rerw Clea Sample Load Options Batch Control Samples Samples Reports List F3 F5 F6 F F8 E9 E010270S EPS 1 Text Field 4 Toggle Button 2 Cursor 5 Check Box 3 Options Button Figure 2 18 Working Area of Program Sample Screen IMMAGE 800 Operations Manual A11403 March 2004 System D
353. ption Page 2 38 IMMAGE 800 Operations Manual A11403 March 2004 Page Up Page Down Definition of Multipage Page Up Page Down Definition of Multipage Some screens contain lists of data If this list contains more data than an individual screen can show the list is said to be multipage Example The chemistry list on the Program Sample screen is a multipage list Use of Page Up Page Down The user can access additional pages of data by selecting the page up and page down buttons on the right The page numbers are shown above the buttons Selecting the Page Down button will advance the page to the next page Selecting the Page Up button will return the page to the previous page These buttons only appear if more than one page of data exists Keyboard Equivalents The keyboard equivalent of the screen Page Up and Page Down buttons are the Page Up and Page Down keys respectively IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 39 Program Structure Introduction Program Structure Introduction The software or interface of the IMMAGE 800 Immunochemistry System is divided into functional areas based on different tasks The icons in the menu bar at the top of the screen represent the various functional areas The following menu tree displays an overview to the structure of the IMMAGE 800 software divided into its functional groups Main Stop Home Pause Run Samples Control Batch
354. qual to the number displayed beside Samples available to program 4 Select OK to proceed to the Program Batch screen Rack and position numbers will be displayed corresponding to the racks selected and the number of samples entered Refer to Figure 7 14 5 Type the desired Sample ID beside each Rack and Position 6 Select End Batch F10 when all Sample IDs are entered IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 49 Identifying Batch Samples Additional Information Select Clear Racks Racks available for batch programming 3 99 Racks to program or clear Rack s 3 4 Samples available to program No of samples in batch OK Cancel E010261S EPS Figure 7 13 Select Clear Racks Dialog Box CETTE C CREE Enter Sample ID E010262S EPS Figure 7 14 Program Batch Screen Bar Code Priority Disabled Additional Information Refer to CHAPTER 5 System Setup Bar Code Setup for more information on enabling and disabling Bar Code Priority Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 50 March 2004 Loading Samples 7 Load Samples Loading and Starting a Run Loading Samples Load Samples To load prepared sample containers into racks and onto the IMMAGE 800 follow these steps Step Action 1 Determine in which rack and position to place sample containers If the sample container Then is b
355. r E011429S EPS Figure 7 17 Request Pause Screen Canceling a Pause Request Select the Cancel button to cancel the pause request This will not affect the current run Refer to Figure 7 17 Restarting a Run Select the RUN button to restart the paused run IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 57 Pausing to Load Samples Introduction Pausing to Load Samples Introduction If the system is running and the user selects the pause option from the IMMAGE 800 main screen the user may choose to pause the system for a sample load This type of pause allows the user to load samples without waiting for the entire sytem to complete all actions The system provides an estimated time period before samples can be loaded based on the time when sample additions removal is allowed Tests currently running on the reaction wheel will continue No further dilutions are created While the remaining tests continue samples may be added or removed The user has the option to resume operations or let the system pause to Standby Pausing Load Samples Step Action 1 Program new samples on a rack that is not on the system 2 During the run select lt Pause gt from Main screen It is recommended not to pause the system during calibration because it may result in a calibration failure Select Load Samples at the Request Pause screen Refer to Figure 7 17 Note that the st
356. r When the instrument status is in Standby proceed with the steps below to enter the serial number of the instrument Step Action 1 From the Setup screen select lt 17 gt Instrument Serial Number Refer to Figure 5 27 2 Type the instrument serial number in the Serial Number field up to 7 alphanumeric characters 3 Select lt OK gt to enter the serial number OR lt Cancel gt to return to the Setup screen without entering the serial number Serial Number Serial Number L1 E010295S EPS Figure 5 27 Serial Number Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 67 UDR Chemistry Overview and Precautions Introduction User Defined Reagent Chemistry Setup UDR Chemistry Overview and Precautions Introduction Each laboratory can define its own user defined reagent UDR chemistry protocols using the templates from the chemistry protocol diskette After the chemistry protocol diskette is loaded and the UDR protocol is defined the UDR chemistry name is available for placement on the list of configured chemistries for selection in UDR rate mode programming reference intervals UDR calibration sample programming control definitions and panels Precautions A CAUTION Since Beckman Coulter does not manufacture or otherwise control the sample and reagents that may be used in user defined reagent applications Beckman Coulter makes no warranty whatsoe
357. r each panel to be defined from the multipage list of panel summaries Available panels have blank Name and Chemistry fields Select Define Edit F1 Refer to Figure 5 4 4 Type the panel name in the Panel Name field up to 15 alphanumeric characters Refer to Figure 5 5 5 Select the number beside each desired chemistry for the panel being defined Selecting Clear Chems F1 will deselect all of the selected chemistries 6 Select the options button lt W gt beside Sample Type 7 Select the sample type The default sample type is determined by the sample type selected on the Default Setup screen Refer to Default Setup Setting the Default Sample Type in this chapter to change the default sample type 8 Select the AGXS check box beside the desired chemistry to enable or disable antigen excess testing 9 Select the options button lt W gt in the Non Std column beside the desired chemistry Select the number beside the desired dilution OR Enter the number of the desired dilution and press Enter 10 To define additional panels select Next Panel F10 to move to the next panel and return to Step 4 11 Select Panels Summary F2 to return to the list of panel summaries IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 9 Panel Setup Defining New Panels Status Enter number from 1 to 58 E014094S EPS Figure 5 4 Panels Summary Screen E Sad EY ET is E ES b F2 aid Enter
358. r must be defined and loaded When the cartridge is level sensed as empty but more tests are available on the Reagent Calibration Status screen the UDR cartridge may be refilled and reused until the tests remaining is zero Loading UDR Cartridges Follow the instructions in CHAPTER 6 Reagents Calibration Loading Unloading Reagent Cartridges Loading Reagent Cartridges Refilling UDR Cartridges A UDR can be programmed to run a maximum of 300 tests If the cartridge holds less than 300 tests the cartridge may be refilled to reach the maximum 300 tests Follow the steps below to refill the UDR cartridge Step Action 1 Go to the User Defined Chemistry screen Refer to Figure 5 28 2 Select a UDR 3 Select Define Edit F1 4 Select lt OK gt to close the warning message 5 Select Refill F8 at the Defined Edit User Defined Chemistry screen Refer to Figure 5 32 6 Select the Cartridge Serial Number on the UDR Cartridge Refill screen Refer to Figure 5 37 1 of 2 System Setup Page 5 88 IMMAGE 800 Operations Manual A11403 March 2004 Loading UDR Reagent Cartridges Loading UDR Cartridges Step Action continued 7 Select Refill The system will update tests remaining in the cartridge to the number of tests defined in the Defined Edit User Defined Chemistry screen OR Select Exit to return to the Defined Edit User Defined Chemistry screen without refilling the cart
359. r the background bar code label on the rack After a bar code is read the database is checked for a program The following table describes the possible displays for Sample ID and Status on the Sample Carousel status screen based on the bar code read and program Table 11 2 Sample ID and Status Displayed Displayed Sample Bar Code Read Is there a program for next torack Carousel Status the rack and position position or for the sample ID SAMPLE ID Programmed Valid sample bar code Yes Host Query or Valid sample bar code No Not Programmed Not Programmed _ Valid sample bar code Sample ID or rack and position conflict lt blank gt Programmed Background bar code Yes Not Programmed Background bar code No NO READ Programmed Invalid or no bar code Yes Not Programmed Invalid or no bar code No IMMAGE 800 Operations Manual A11403 System Status Instrument Commands Page 11 5 Checking the Instrument Status Monitor Introduction Checking the Instrument Status Monitor Introduction The instrument status monitor displays the instrument parameters which are continuously monitored Accessing Instrument Status Monitor Follow the steps below to access the instrument status monitor Step Action 1 Select Status from the menu bar 2 Select lt 3 gt Instrument Status Monitor Refer to Figure 11 3 3 Verify acceptable status monitor parameters Parameters
360. rammed by a host computer the Control ID sent from the host must be programmed for only the chemistries defined for that control must not match any patient Sample ID that is sent for the same run IMMAGE 800 Operations Manual A11403 Sample Programming Page 7 39 Programming a Control Programming a Non bar Coded Control Programming a Non bar Coded Control Follow the steps below to program a non bar coded control Step 1 Action Select Select Control F5 from the Program Sample screen 2 Type the number of the desired control and press Enter Refer to Figure 7 10 OR Select the number beside the desired control OR Select lt Cancel gt to return to the Program Sample screen without selecting a control Enter a Rack and Position number Refer to Figure 7 11 AND Select the options button lt W gt beside the Control ID field to select a Control ID A Control ID is optional NOTICE If a control is programmed with a Control ID and the host sends a patient sample with an ID identical to the control the programmed control will be deleted Select or deselect panels and or chemistries if necessary Select Clear Chems F7 to deselect all chemistries Refer to Selecting Chemistry Tests by Panel and Selecting Chemistry Tests by Chemistry in this Section Select Sample Options F3 if needed Refer to Selecting Sample Options in this Section Select Select Control F5
361. rations Manual A11403 Sample Programming March 2004 Page 7 25 Entering Patient Demographics Entering Demographics Entering Demographics Follow the steps below to enter patient demographics from the Demographics screen Step Action 1 Type or select the appropriate information in each field Refer to Table 7 5 for a description of field entries 2 When all desired Demographics are entered To Select return to the same sample Program Sample F1 advance to the next sample Save Next F10 Table 7 5 Demographic Field Entries Field Entries Notes Patient ID 15 alphanumeric characters Patient ID may be entered from the Program Sample screen Name Last name 18 alphanumeric characters First name 15 alphanumeric characters MI Middle Initial 1 alphabetic character Date of mm 1 12 The order and the separator Birth dd 1 31 character are defined in Setup yyyy 1850 2035 Sex Select the options button lt W gt The options are beside the Sex field Male Female M F Select an option from the list The default is M F Age units Select the options button lt W gt The options are beside the Age field Hours Days Weeks Months Select an option from the list Years The default is Years Age Hours 0 999 Age is automatically calculated Days 0 999 if Date of Birth is entered Weeks 0 999 Age is automatically Months 0 999 recalculated if Age units a
362. rder to proceed with the steps below to set the computer port parameters for communications of the IMMAGE 800 to a host Host Communications Setup Setting Computer Port Parameters computer Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21 2 Select the options button lt W gt next to one of the following parameters refer to Table 5 5 Baud Rate Stop Bits Parity Data Bits 3 Select the choice that matches the parameter of the host Select Cancel to exit the dialog is without setting a parameter The choices are shown in Table 5 5 4 Repeat Steps 2 3 to set additional parameters Table 5 5 Computer Port Parameter Choices Baud Rate Stop Bits Parity Data Bits lt 1 gt 2400 lt 1 gt 1 lt 1 gt None lt 1 gt 8 lt 2 gt 4800 lt 2 gt 2 lt 2 gt Even lt 2 gt 7 lt 3 gt 9600 lt 3 gt Odd lt 4 gt 19200 IMMAGE 800 Operations Manual A11403 March 2004 System Setup Page 5 51 Host Communications Setup Setting the Timeout Value Setting the Timeout Value The timeout value is the time the IMMAGE 800 will wait for an answer to a query of the host before timing out and canceling the query The instrument status must be in Standby in order to proceed with the steps below to set the timeout value Step Action 1 From the Setup screen select lt 10 gt Host Communications Refer to Figure 5 21
363. re Years 0 999 changed 1 of 2 Sample Programming IMMAGE 800 Operations Manual A11403 March 2004 Entering Patient Demographics 7 Additional Information Table 7 5 Demographic Field Entries continued Field Entries Notes Patient 45 alphanumeric characters Comment Doctor 18 alphanumeric characters Location 20 alphanumeric characters Collection mm 1 12 The order and the separator Date dd 1 31 character are defined in Setup yy 0 99 The default date is the current date Collection hh 0 23 The time format is defined in Time mm 0 59 Setup as 12 hour or 24 hour 24 hour The separator character is format defined in Setup Collection hh 1 12 The time format is defined in Time mm 0 59 Setup as 12 hour or 24 hour 12 hour The separator character is format AM PM defined in Setup Select the options button W beside the Collection Time field Select AM or PM Collected 18 alphanumeric characters By The default is AM 2 of 2 Additional Information Refer to CHAPTER 5 System Setup Demographic Setup for more information on disabling demographic fields and Date and Time Setup for more information on defining date and time formats IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 27 Selecting Sample Options Introduction Selecting Sample Options Introduction To access the Sample Options dia
364. reen Step Action 1 Select Utilities from the menu bar 2 Select lt 11 gt Calibrate Touch Screen from the Utilities dialog box OR Enter 11 in the Option No field and press Enter Refer to Figure 10 34 To calibrate and enable the touch screen with one finger or an appropriate object touch the crosshairs in the upper left quadrant of the display area twice Next touch the crosshairs in the lower right quadrant of the display area twice OR To exit without saving the calibration select lt Cancel gt or any key on the keyboard NOTICE The touch screen will not be activated if the first calibration attempt is canceled prior to touching both crosshairs If a previous calibration exists canceling a calibration attempt retains the previous calibration data After calibration software functions can be activated by the touch of a finger or other object Any icon button or field on the screen can be selected by touching the icon button or field on the screen Once the touch screen is activated it cannot be turned off Utilities Page 10 68 IMMAGE 800 Operations Manual A11403 March 2004 Calibrate Touch Screen Calibrating the Touch Screen 11 Calibrate Touch Screen 2 Event Log 12 Shutdown 3 Diagnostics 4 Alignment 5 Format QNX Diskettes 6 Backup Restore 7 Mash Cuvettes 8 Fin Internal Wash Bottle g Stop Print 18 Reload DAS Code
365. ridge 8 Refill the cartridge 2 of 2 S Host Off 02 05 2004 16 23 eiWigimimriglisiEll Chem Name UDRI Reagent Lot Number 1234ABC Tests per cartridge 25 Serial Number Tests left Total tests left E999 7 282 Figure 5 37 UDR Cartridge Refill Screen The UDR Cartridge Refill screen Figure 5 37 is defined in Table 5 13 Table 5 13 UDR Cartridge Refill Screen Screen Item Screen Definition Chem Name Chemistry Name as defined in Figure 5 32 Reagent Lot Number Reagent Lot Number as defined in Figure 5 32 Tests per cartridge Tests per cartridge as defined in Figure 5 32 Serial Number Cartridge Serial number as defined in Figure 5 32 Tests left Number of tests remaining from tests per cartridge defined in Figure 5 32 Total tests left Number of tests remaining from 300 total tests per cartridge IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 89 Loading UDR Reagent Cartridges Removing UDR Cartridges Removing UDR Cartridges Follow the instructions in CHAPTER 6 Reagents Calibration Loading Unloading Reagent Cartridges Removing Cartridges from The Reagent Carousel System Setup IMMAGE 800 Operations Manual A11403 Page 5 90 March 2004 Loading Clearing UDR Buffer and Diluent Introduction Loading Clearing UDR Buffer and Diluent Introduction Beckman Coulter IMMAGE 800 buffers and diluents or user prepared solutions may be used as UDR buffer and diluent
366. robe by gently bending it marks to center of the tape marks A014079P EPS Figure 10 30 8 Reinstall the sample carousel cover 5 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 59 Alignment Sample and Reagent Crane Probe Height Depth Sample and Reagent Crane Probe Height Depth Step Action continued 9 Reinstall the access cover of the Crane Assembly Position the tubing in the grooves before tightening the screws 6 of 6 Follow the steps below to align the Sample or Reagent Crane Probe height depth Step Action 1 Select Utilities from the menu bar 2 Select lt 4 gt Alignment OR Enter 4 in the Option No field and press Enter 3 If then aligning the Sample Probe 1 Select 9 Sample Crane Probe from the Functional Areas dialog box OR Enter 9 in the Area No field and press Enter 2 Select 1 Sample Crane Probe from the Alignment dialog box OR Enter 1 in the Procedure No field and press Enter aligning the Reagent Probe 1 Select 10 Reagent Crane Probe from the Functional Areas dialog box OR Enter 10 in the Area No field and press Enter 2 Select 1 Reagent Crane Probe from the Alignment dialog box OR Enter 1 in the Procedure No field and press Enter 1 of 2 Utilities Page 10 60 IMMAGE 800 Operations Man
367. rt is marked with a yellow warning symbol beside the value on the QC Log and QC Chart screens is highlighted in a real time pop up window on the monitor as the system is running IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 3 QC Statistics and Rules Flags Generated on Printed QC Reports 1 3SD Result Greater Than 3SD From the Assigned Mean If the result is greater than 3 SD from the assigned mean the result is flagged as 3SD on the QC Log report is marked with a red warning symbol beside the value on the QC Log and QC Chart screens is highlighted in a real time pop up window on the monitor as the system is running 2 28 and R 4S Results Between 2 SD and 3 SD as Compared to the Previous Result In addition the Z score for the current result is compared with the Z score of the previous result in the same QC file If both Z scores are beyond 2 SD on the same side of the assigned mean the current result receives an Accuracy flag on the QC Log report this flag signifies a violation of the 2 28 rule These values appear with a red warning symbol in the QC Log and QC Chart If the two results being compared are greater than 2 SD on opposite sides of the assigned mean the current result receives the Precision flag on the QC Log report signifying a violation of R 4S rule These values appear with a red warning symbol in the QC Log and QC Chart Results Greater Than 4 SD From
368. run Summary can be requested at any time A Load List contains the following information for each sample when applicable Rack Position e Sample ID Patient Name e Sample Type Off line Dilution Factor Chemistries including replicates e Sample status STAT designation Rerun designation A Post run Summary contains the following information for each sample Rack Position e Sample ID Date and time programmed Pending tests Test status Reason for each incomplete test Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 70 March 2004 Requesting a Load List Introduction Requesting a Load List Introduction A Load List can be requested by one of the following options e Sample ID and or a range of Sample IDs Rack Position Date Time e Sample Status When a Load List is requested it can be displayed and or printed Refer to Figure 7 22 Load List By Samen Range Thru Rack s Pos s Date Time From Status Print Display Cancel E010264S EPS Figure 7 22 Load List Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 71 Requesting a Load List Requesting Load List by Sample ID Requesting Load List by Sample ID Follow the steps below to request a Load List by Sample ID Both individual Sample IDs and a range of Sample IDs can be entered Step Action 1 Select Load List F9
369. ry information 15 A Define Edit Controls dialog box is displayed when the Assigned Mean field and or Assigned SD field are set to 0 or there are no values entered in the Assigned Mean field and or Assigned SD field Select 1 Save file s with Mean 0 0 SD 99999 to set the mean to 0 and the SD to 99909 for the chemistries in question 2 Delete undefined file s from this control delete the chemistries in question from the control Cancel to return to the Define Edit screen and enter the mean and or SD 2 of 2 Quality Control Page 9 8 IMMAGE 800 Operations Manual A11403 March 2004 Defining a Control Entering the Minimum Control Definition Host Off QC Data Source Hard Disk z Control Name Control Lotit 1 Pax M612141 z PRX2 M612142 M612143 E014029S EPS Figure 9 2 Quality Control Screen 100 07 of QC results storage remaining 99 4 of QC file numbers remaining E014031S EPS Figure 9 3 Define Edit Controls Screen IMMAGE 800 Operations Manual A11403 March 2004 Quality Control Page 9 9 Defining a Control Control ID Host Off 1880 0 of QC results storage remaining 99 4 of QC file numbers remaining Incomplete control information QC File Number Control Name Lot Number and Sample Type must be defined and one chemistry selected to save definition Exit without defining the control
370. s Introduction The following section describes the QC rules used by the Quality Control feature Determination of QC Flags The IMMAGE 800 uses the Z score method for standardizing the scale of a normally distributed measurement variable For an individual control result the Z score represents the distance in standard deviations from the assigned mean The Z score is calculated from the following equation where the individual control result the assigned mean for the control the assigned standard deviation for the control E011375L EPS Each time a control result 1s received the Z score is calculated If the Z score is less than 2 SD the result is within the assigned control range the assigned mean 2 assigned standard deviations and is considered acceptable Results are flagged at time of run Flagging is not changed if the operator modifies the assigned mean and or SD If the operator chooses to use a QC program other than the IMMAGE 800 QC program assigning a mean of 0 and an SD of 99999 for a chemistry prevents additional flagging of the results in the IMMAGE 800 QC database and on the IMMAGE 800 screen Accuracy and Precision Flags The IMMAGE 800 utilizes the following Westgard rules for evaluation of QC data 1 2S Result Between 2SD and 3SD From the Assigned Mean If the result is between 2 and 3 standard deviations from the assigned mean the result is flagged as gt 2SD on the QC Log repo
371. s March 2004 Page 10 13 As Indicated Maintenance As Indicated As Indicated Maintenance As Indicated The following table lists the As Indicated maintenance for the IMMAGE 800 System Table 10 5 As Indicated Maintenance Clean Perform Clean or replace printer cartridge Refer to Printer Manual Replace all Cuvettes every 10 000 tests For systems using DIL2 cuvettes may need to be replaced more frequently Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix F System Reagent Configuration and Part Numbers for chemistries using DIL2 Decontaminate Sample Reagent Carousels and Sample Racks Cuvette Wash Replace syringes if leaking occurs or as needed Replace UPS battery when battery low light or audible alarm is activated Refer to UPS User s Manual Decontaminating Carousels and Racks To decontaminate the sample or reagent carousels or sample racks perform the following steps Verify from the status bar that the instrument status is in Standby DO NOT Autoclave Carousels or Sample Racks NOTICE Utilities Page 10 14 IMMAGE 800 Operations Manual A11403 March 2004 As Indicated Maintenance Decontaminating Carousels and Racks Step Action 1 To remove the reagent carousel lift the reagent cover 1 A010094PEPS Figure 10 8 2 Pull up on the carousel 1 A010046P EPS Figure 10 9
372. s Page 10 74 IMMAGE 800 Operations Manual A11403 March 2004 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Step Action continued 5 Disconnect the probe level sense cable from the IMMAGE 800 by pulling the connector 1 straight out from the receptacle Refer to Figure 10 39 Figure 10 39 6 Disconnect the RF cable by pulling the connector 1 straight out from the receptacle Refer to Figure 10 40 A012189P EPS Figure 10 40 3 of 6 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 75 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Step Action continued 7 At the crane assembly remove the small set screw 1 located near the top right side of the probe RF radio frequency shield housing 2 a brass cylinder Refer to Figure 10 41 A014086P EPS Figure 10 41 Pull the probe up and out from the crane assembly Refer to Figure 10 42 A012191P EPS Figure 10 42 4 of 6 Utilities Page 10 76 IMMAGE 800 Operations Manual A11403 March 2004 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Step Action continued 9 Remove the set screw on the new probe Refer to Figure 10 43 Install the new probe into the crane assembly AO12190P EPS Figure 10 43 NOTICE Align the hole of the probe with the access hole
373. s or Print Last Calibration Results Displaying Calibrator Lot Parameters The instrument status must be in Standby in order to follow the steps below to display calibrator lot parameters Step Action 1 Select Rgts Cal from the menu bar Select Cal Options F5 Select lt 1 gt Calibrator Summary Refer to Figure 6 13 2 3 4 Select a button beside the Calibrator to be displayed THEN Select the lt Display gt button to view the calibrator lot parameters Refer to Figure 6 14 OR Select lt Go To gt and type the Cal and Lot number Select lt OK gt from the Calibrator Lot Display dialog box when finished viewing the calibrator lot parameters Calibrator Summary Display Exp Date M5809106 85 01 1997 503084 11 01 1996 510003 86 01 1997 M502005 09 01 1995 IES11008 61 01 1997 511197 08 01 1997 Delete GoTo OK E010302S EPS Figure 6 13 Calibrator Summary Dialog Box Reagents Calibration Page 6 36 IMMAGE 800 Operations Manual A11403 March 2004 Cal Options Printing Calibrator Target Values Calibrator Lot Display Sample Type Expiration Date 96 01 1997 Rework Chen Target Value Chem Target Value 201 51 5 398 1458 134 1300 OK Print CAL 1 M5100063 Serum mg dL mg dL mg dL mg dL mg dL g L E010301S EPS Figure 6 14 Calibrator Lot Display Dialog Box Printing Calibrator Target Values Follow the steps below to print c
374. s poured wrong contro 04 23 1998 14 52 30 mg dl DELETED 04 24 1998 09 16 jis poured wrong control 04 23 1998 14 30 28 ma dt DELETED 04 24 1998 09 16 gis poured wrong contrat 04 23 1998 14 30 18 mazdt DELETED 04 24 1998 09 16 dts poured wrong control 04 23 1998 14 29 58 may dt DELETED 04 24 1998 09 16 Jis poured wrong control 04 23 1998 14 29 mg dt DELETED 04 24 1998 09 16 gts poured wrong control 04 23 1998 14 03 mg dL 250 04 23 1998 i ma dL 04 23 1998 t mg dl 04 23 1998 E D mg dt 04 23 1998 5 t mg dl 04 23 1998 i me al 04 23 1998 ES mg dt 04 23 1998 E014110L EPS Figure C 18 QC Log by Reagent Lot IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 19 Introduction QC Chart Report QC Chart Report IMMAGE S N PPI 2 8 Control Name Lot Number Sample Type Chemistry Result Date 04 24 98 04 24 98 04 23 98 04 23 98 04 22 98 04 22 98 04 21 98 04 21 98 04 20 98 04 20 98 04 17 98 04 17 98 04 14 98 04 14 98 04 13 98 04 13 98 04 10 98 04 10 98 04 09 98 04 09 98 04 08 98 04 08 98 04 03 98 04 03 98 04 02 98 04 02 98 Figure C 19 QC Chart Report 09 02 09 01 09 13 09 12 09 00 08 59 12 49 12 48 09 13 09 12 09 19 09 18 10 39 10 38 10 20 10 20 08 47 08 46 09 57 09 56 10 17 10 16 09 04 09 04 09 19 09 18 VIGIL PRX2Z M612142 Serum 1 N u D 1 N eee A iS M o QC CHART REPORT BECKMAN INSTRUMENTS BECKMAN INSTRUMENTS
375. s Batch Control Samples Samples Summaru List Next Fi F2 F3 F4 F5 F6 FZ F8 F9 F18 6 Enter Sample ID E011413S EPS 1 Status Bar 5 Function Buttons 2 Menu Bar 6 Message Bar 3 Icon Button 7 Working Area 4 Title Bar Figure 2 17 Sample Programming Screen Status Bar The blue bar at the top of the screen is the status bar This bar shows the instrument status date and time IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 27 Screen Format Menu Bar Menu Bar Title Bar Below the status bar is a row of icon buttons called the menu bar These icon buttons can be selected to access various functional areas of the interface These areas are Main e Samples Results Rgts Cal Reagent load and calibration QC Quality control e Setup Utils Utilities e Status e Stop F12 About The menu bar consists of these specific icon buttons regardless of the current screen Below the menu bar is a bar containing the title of the current screen with some possible additional information Function Buttons At the bottom of the screen is an area for up to ten function buttons These function buttons perform functions that are specific to the particular screen Each function button on the screen corresponds to a function key on the keyboard read from left to right F1 F2 F3 etc The screen function buttons are labeled with the action the function button performs and the corres
376. s Data Curve Host Off Pos Replicate Enter Rack Number 1 99 E011438S EPS Figure 5 55 Plot Robust Means Data Curve Window tandby Host Off am mm meli R o b u s M e a n s Edit Time Print Range E Figure 5 56 Plot Robust Means Data Curve E011439S EPS IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 111 Approving a Calibration Editing the Time Range on a Robust Means Data Curve Editing the Time Range on a Robust Means Data Curve The time range can be edited on a Robust Means Data curve in order to focus on a particular area of the curve Perform the following steps to edit the time range Step Action 1 Refer to Figure 5 56 and select Edit Time Range on the Robust Means Data Curve A Time Range window appears as shown on Figure 5 57 Enter the new starting time and ending time in the Time Range window The new starting ending times must be within the original time range as shown on the initial data curve A new Time Range screen appears that shows the edited times Select lt OK gt to plot the new curve and proceed to Step 4 OR Select Default to return to the original curve and time range OR Select lt Cancel gt to return to the previous screen Select lt Exit gt to return to the Plot Robust Means Data Curve screen Figure 5 55 OR Select Edit Time Range again and repeat this procedure OR Select Print to print the the Plot
377. s Manual A11403 Sample Programming March 2004 Page 7 81 Overview Operating in Bi directional Mode Operating in Bi directional Mode Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using bi directional mode Step Action 1 Check and clear as necessary e sample racks Check clear and replace as necessary e dilution segments Check e reagents buffers and diluents e wash solution volume Refer to Preparing for Programming Running in this chapter Request calibrations if necessary Refer to CHAPTER 6 Reagents Calibration Send sample programming from the host computer according to the laboratory s procedure If samples are then bar coded load samples in any rack and position not bar coded load samples in racks and positions assigned by the host Refer to CHAPTER 2 System Description Sample Container Information Select Main from the menu bar AND Select Run Select lt OK gt in the Check Dilution Segments dialog box to start the run OR Select lt Cancel gt to exit without starting the run Sample Programming Page 7 82 IMMAGE 800 Operations Manual A11403 March 2004 Step Overview Operating Without Host Communications Operating Without Host Communications Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using unidirectional mode Action
378. sample function buttons 7 13 Recalling by patientID 8 7 Program sample screen 0 00 7 11 Recalling by rack and positi0N 8 5 Program sample working area Recalling by run date time o o 8 9 Antigen excess testinQ 7 12 7 18 Recalling by sample ID 00 8 3 Green box 2 0 cece eese 7 12 Recommended QC analysis intervals 9 2 Non standard dilutions 7 13 Re enabling calibration 6 35 Patient D 2 ai Wate wees 7 12 Re enable previous calibration dialog box 6 35 Sample comment 00000 0c eee 7 12 Reference cuvette 0 0 eee eee 2 9 Programming a STAT sample 7 43 Reference interval 0 00 e eee eee 5 17 Programming non bar coded control 7 40 Reference interval critical ranges dialog box 5 18 Proper handling of compact disks 1 6 Reference interval critical ranges screen 5 18 Proper handling of diskettes 1 6 Regulatory agency approvals 2 47 Protein calibration curve Removing cartridges from the reagent carousel 6 16 Antibody excess 0 0 ce eee eee eee 3 12 Removing the reagent carousel 6 16 Antigen excess 0 eee eee ee 3 12 Replacing a dilution segment 7 7 Maximum rate response
379. sample programming is saved Home Reagent and sample carousels cuvettes and probes return to their home position Pause Stops instrument after current samples that are running are completed All sample programming is saved OR Pauses instrument to load samples during a run Run Starts a run Accessing Instrument Commands Follow the steps below to access the instrument command buttons Step Action 1 Select Main from the menu bar 2 Select the desired command IMMAGE 800 Operations Manual A11403 System Status Instrument Commands March 2004 Page 11 7 Accessing Instrument Commands The Stop Command and Cuvette Maintenance The Stop Command and Cuvette Maintenance The following steps are recommendations for maintenance of the cuvettes after the Stop command is selected Table 11 4 Recommended Maintenance After Stop Command Selected After Stop is selected the cuvettes during a run and before Run is selected immediately 1 hour do not require maintenance less than 24 hours later should be washed Refer to CHAPTER 10 Utilities As Indicated Maintenance Washing Cuvettes more than 24 hours later should be replaced Refer to CHAPTER 10 Utilities As Indicated Maintenance Replacing Cuvettes System Status Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11 8 March 2004 APPENDIX A Part Number List Table A 1 Part Num
380. sel Ensure that the reagent cartridge is correctly placed into the groove on the carousel Refer to Figure 6 7 Close the reagent compartment cover Note If calibration and reagent status do not need to be reviewed proceed to sample programming Refer to CHAPTER 7 Sample Programming Select Read Reagents F1 of 2 Reagents Calibration Page 6 14 IMMAGE 800 Operations Manual A11403 March 2004 Loading Unloading Reagent Cartridges Loading Reagent Cartridges Step Action continued 7 Select OK to initiate the reagent cartridge read and go to Step 8 OR Select Cancel to return to the Reagent Status Calibration Status screen without reading the reagent cartridges 8 If the screen will display the load is successful updated reagent status information the load is unsuccessful an error message Refer to CHAPTER 10 Utilities Troubleshooting the cartridge is expired a warning message the cartridge is exhausted Tests Left as zero 2 of 2 Figure 6 7 Loading Reagent Cartridges on the Reagent Carousel IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 15 Loading Unloading Reagent Cartridges Removing the Reagent Carousel Removing the Reagent Carousel The instrument status must be in Standby in order to proceed with the steps below to remove the reagent carousel from the IMMAGE 800 upon c
381. sing Sample Carousel Status Follow the steps below to access the sample carousel status Step Action 1 Select Status from the menu bar 2 Select 2 Sample Carousel Status Refer to Figure 11 2 06 27 1996 89 42 ewa DU l be ER SS Main Samples Results Rgts tal OC Setup Utils Status STOP Sample Carousel Status lot Programmed exHost Query baiting to Run Running ealncomplete coComplete E010303S EPS Figure 11 2 Sample Carousel Status Screen System Status Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11 4 March 2004 Checking Sample Carousel Status Description of Sample Carousel Status Description of Sample Carousel Status The following table describes the sample carousel status indicator colors and sample carousel status terms Table 11 1 Sample Carousel Status Indicator Status Description Color White Not Programmed Sample is not programmed or saved Purple Host Query Sample ID queries the host for programming Yellow Waiting to Run The sample carousel was scanned and the sample program is recognized by the system Green Running One or more tests requested for the sample are running Red Incomplete At least one test result for the sample is pending Blue Complete All tests requested for the sample are complete Sample IDs and Bar Code Reads The sample bar code reader will read either the sample bar code label o
382. sive Azide Hazards 8 16 76 Incineration of used reagent cartridges may produce toxic fumes General Information Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1 8 March 2004 Symbols and Labels Introduction Symbols and Labels Introduction The following list of symbols and labels is used on the IMMAGE 800 Immunochemistry System The symbols are affixed to the appropriate components of the system as described briefly below Instrument or Uninterruptible Power Supply UPS Power Switch ON This symbol is located on the instrument and the UPS main power switches When the portion of the switch that displays this symbol is depressed the instrument is ON A 00052C EPS Instrument or UPS Power Switch ON Instrument or UPS Power Switch OFF This symbol is also located on the instrument and the UPS main power switches When the portion of the switch that displays this symbol is depressed the instrument is O A_00053C EPS Instrument or UPS Power Switch OFF Computer Power Switch This symbol is located above the computer power button A green light indicates the power to the computer is ON AO10555L EPS Computer Power Switch IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards March 2004 Page 1 9 Symbols and Labels Monitor Power Switch Monitor Power Switch This symbol is located on the monitor power button A green light indicates the power to the monitor
383. specific calibration for that cartridge will be overwritten Follow the steps below to access the Calibration Information screen that summarizes calibration status Step Action 1 From the Reagent Status Calibration Status screen select the options button lt W gt beside Cal ID for the desired chemistry If View the Calibration Information dialog box for the desired information Then recalibration is requested for a chemistry and one of the cartridges meets the cartridge specific calibration criteria calibration status is Requested for that cartridge only a newly loaded cartridge has the same lot number as a cartridge with previous cartridge specific calibration the reagent lot calibration not cartridge specific applies to the new cartridge Calibration status is the same as the reagent lot calibration status prior to loading the new cartridge the lot number of the reagent is new to the system calibration status is Uncalibrated for all cartridges of that lot on the system IMMAGE 800 Operations Manual A11403 March 2004 Reagents Calibration Page 6 23 Cartridge Specific Calibration Calibration Events Calibration Events Reagents selected for cartridge specific calibration should be calibrated using the same method as that used to calibrate other reagents The table below presents a set of varying conditions and their corresponding eve
384. st tube Place the appropriate calibrator in the sample cup 4 Repeat steps 1 3 for any additional calibrators Continue placing calibrators into the same sample rack Open the sample compartment cover 6 Place the rack s containing calibrators on the sample carousel Rotate the sample carousel by pressing the advance button on the instrument NOTICE Place racks containing calibrators in position A and B Controls and or patient samples may be placed in any other positions on the sample carousel Refer to CHAPTER 7 Sample Programming 7 Close the sample compartment cover IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 31 Loading Calibrators on the Sample Carousel Programming Samples and Controls Cal Load List Rack Pos Cal ID 2 UCAL H511197 IGU IGG IGA IGM C3 C4 Chems 3 3 1 CAL 1 M583884 Figure 6 12 Cal Load List Dialog Box Programming Samples and Controls Samples and controls may be programmed on a calibration run Refer to CHAPTER 7 Sample Programming Reagents Calibration Page 6 32 IMMAGE 800 Operations Manual A11403 March 2004 Starting a Calibration Run Introduction Starting a Calibration Run Introduction After the calibration has been requested and calibrators are placed into position the calibration run is started Starting a Calibration Run Follow the steps below to start the calibration run Step Action 1 Select Main from the men
385. sts remaining in the reagent cartridge Lot Lot number of the reagent Serial Number Serial number of the reagent cartridge Cal Status Current calibration status of the reagent cartridge Cal date Date of calibration Cal ID Name of calibrator Options button lt W gt Calibrator information beside the Cal ID IMMAGE 800 Operations Manual A11403 March 2004 Reagents Calibration Page 6 3 Reagent Status Calibration Status Screen Function Button Description Function Button Description The following table describes the function buttons at the bottom of the Reagent Status Calibration Status screen Table 6 2 Function Buttons Name Button Function Read Reagent F1 Reads the bar coded label on the reagent cartridges that are loaded on the reagent carousel Reagent Summary F2 Lists the chemistry name reagent lot reagent expiration date calibration status calibration date and calibrator lot for all reagents which have had bar code parameters loaded into the database Buffer Diluent F3 Allows set up of buffer or diluent positions on reagent or sample carousel Displays the Remaining volume of buffer or diluent Request Cal F4 Requests calibration of selected chemistries Cal Options F5 Allows the selection of one of the following options Calibrator Summary Slope and Offset Adjustments Cal LdList F6 Displays a load list of requested calibrations Cancel R
386. t Identifies UDR mean instrument responses per replicate of single point update calibrator for the selected chemistry the curve fit model associated parameters and scale factor Plot Robust Means Data Report Identifies UDR robust means data for a single replicate of a selected UDR calibrator or rate mode report Rate Mode Results Identifies UDR instrument responses per replicate of each UDR sample for the selected chemistry Patient Results Identifies UDR concentrations per replicate of patient sample programmed IMMAGE 800 Operations Manual A11403 System Setup Page 5 113 Printing UDR Reports Printing UDR Reports Printing UDR Reports The instrument status must be in Standby in order to proceed with the steps below to print UDR reports Step Action 1 From the Setup screen select lt 18 gt User Defined Chemistries 2 From the User Defined Chemistries screen choose one of the defined UDR positions Select Print Plot F10 to display the report options 4 Select the number beside the report desired Select lt OK gt to print the report OR Select lt Cancel gt to return to the User Defined Chemistry screen Printing UDR Rate Mode and Patient Results Follow the instructions in CHAPTER 8 Results Recall Printing Recalled Results to reprint UDR rate mode and patient results System Setup IMMAGE 800 Operations Manual A11403 Page 5 114 March 2004 Setting Up UDR Refere
387. t 1 gt Dilution Segments 3 If dilution segments are then to be cleared Type the segment number s in the Clear Segment s field Numbers can be separated by a comma as a series or by a dash as a range OR Select the numbered button beside each appropriate segment AND Select lt OK gt not to be cleared Select lt Cancel gt After Clearing Segments Always replace the cleared dilution segments with unused segments on the sample carousel before a run is started Sample Programming Page 7 6 IMMAGE 800 Operations Manual A11403 March 2004 Checking Status and Clearing Replacing Dilution Segments 7 Replacing Dilution Segments Replacing Dilution Segments The instrument status must be in Standby in order to proceed with the steps below to replace dilution segments Step Action 1 Lift the cover of the sample carousel 2 Rotate the sample carousel by pressing the advance button in order to access the desired dilution segment if necessary 3 Lift the segment to be replaced off of the sample carousel Refer to Figure 7 1 4 Dispose of the used segment in a manner appropriate for biohazardous materials 5 Place an unused segment in the empty position on the sample carousel 6 Repeat Steps 2 5 until all desired segments are replaced 1 Dilution Segment Figure 7 1 Replacing a Dilution Segment Additional information Refer to CHAPTE
388. t Chart Using Westgard Rules IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 5 Defining a Control Introduction Defining a Control Introduction The Define Edit option allows definition of up to 100 control names The minimum information required to save a control definition is control name lot number sample type one chemistry selection QC file number Mean e Standard Deviation SD In addition the assigned mean standard deviation SD and constituent code can be defined for each chemistry in a control Control IDs can also be assigned to a control Grouping Chemistries Under a Control Name All chemistries appearing in a control definition must be of the same sample type and have the same sample preparation Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual for specific information QC File Number The QC file number is a number from 1 999 which is unique to a chemistry defined within a control name If the QC file number has already been assigned the database will not accept it a second time The file number can be reused after a chemistry in a control is deleted Assigned Mean and Assigned SD For initial setup of control definitions the mean and standard deviation SD values from commercial quality control inserts may be used When the laboratory establishes its own mean and SD ranges these values should be used instead of the insert values The me
389. t an icon from the menu bar to exit the screen Setting the Post Run Summary Time Limit Refer to CHAPTER 5 System Setup Default Setup Setting the Default Post Run Summary Time Search Sample Programming Page 7 76 IMMAGE 800 Operations Manual A11403 March 2004 mW T Clearing a Sample Overview Introduction A sample can be cleared by Sample ID and or a range of Sample IDs or by Rack and Position Refer to Figure 7 24 Up to 10 000 Sample IDs can be stored in the database When a sample is cleared by Sample ID the associated Position on the Rack becomes available for programming the Sample ID can be reused the Sample Program cannot be recalled by Rack and Position or Sample ID When a sample is cleared by Rack and Position the associated Position on the Rack becomes available for programming the Sample ID cannot be reused the sample program cannot be recalled by Rack and Position Clear Samples Clear Sample IDs Range Thru Clear Racks Positions Rack s Pos s OK Cancel E010266S EPS Figure 7 24 Clear Samples Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 77 Clearing a Sample by Sample ID Clearing by Sample ID Clearing a Sample by Sample ID Clearing by Sample ID Follow the steps below to enter Sample IDs to be cleared Both individual Sample IDs and a range of Sample IDs can be entered Step Action
390. t the minute displayed above the mm if needed delete the currently displayed minute type the correct minute in its place The digits for minute can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by entered for four minutes after the hour 3 If the time format is set to twelve hour mode correct the AM PM setting if necessary 1 Select the button beside the AM or PM 2 Select 1 for AM or 2 for PM 6 Select lt OK gt to save the changes OR Select Cancel to return to the Date and Time screen without saving the changes Change Time Cancel E010226S EPS Figure 5 20 Change Time Dialog Box 24 hour format System Setup IMMAGE 800 Operations Manual A11403 Page 5 48 March 2004 Date and Time Setup Setting Back the Date Time Setting Back the Date Time After the date time is set back an overlapping time period is created Example Old time 11 PM New set time 10 PM The overlapping time period is 1 hour If a run is finished at 11 PM old time and another is run finished by11 PM new time the overlapping time period of 1 hour will have results and load lists from both runs If these results and load lists are recalled by date and time both sets of results and load lists will display IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 49 Host Communications Setup Introduction Host Communications Setup
391. t with Dilutions Laboratory Report with Dilutions IMMAGE S N PPI1 9 07 18 1996 13 00 59 BECKMAN INSTRUMENTS INC 200 S KRAEMER BLVD BREA CALIFORNIA 92622 8000 RACK POS 3 4 SAMPLE TYPE Serum SAMPLE ID 12345 RUN DATE TIME 07 18 1996 10 17 PATIENT ID OFF LINE DIL RESULTS UNITS REFERENCE INTERVAL ma dL mg dL mg dL ma aL mg dL SAMP COMMENT INSTRUMENT CODES E010313L EPS Figure C 4 Laboratory Report with Dilutions IMMAGE 800 Operations Manual A11403 Reports March 2004 Page C 5 Introduction Calibration Load List Calibration Load List IMMAGE S N PPI1 9 Figure C 5 07 18 1996 11 11 48 PAGE 1 BECKMAN INSTRUMENTS INC 200 S KRAEMER BLVD BREA CALIFORNIA 92622 8000 CALIBRATION LOAD LIST M511197 M503084 IGG IGA IGM C3 C4 E010314L EPS Calibration Load List Reports Page C 6 IMMAGE 800 Operations Manual A11403 March 2004 Introduction Calibration Report Calibration Report 07 18 1996 11 32 00 Page 1 IMMAGE S N PPI1_9 BECKMAN INSTRUMENTS INC 200 S KRAEMER BLVD BREA CALIFORNIA 92622 8000 CALIBRATION REPORT IS STAT ete ee CAL ID CAL 1 M503084 RACK POS REACTION BUFFER BUF1 T510169 SAMPLE DILUENT DIL1 7510168 INSTRUMENT TARGET CAL LOT RESPONSE RESPONSE VALUE UNIT DILUTION M511204 Ge e 1520 00 mg dL 1520 00 mo du mg du IGG CALIBRATED TO 1520 00 mg dL 18 wR STAT vetted CAL ID CAL I1 M503084 RACK POS REACTION BUFFER BUF1
392. tables explain what happens after all reagents and samples have been loaded and Start Run has been selected Table 2 10 Start Up Functions Stage Description 1 The IMMAGE 800 will home moving parts prime wash through the lines wash the probes perform internal diagnostic checks 2 A fluid level sense is performed on all Buffer and Diluent bottles The 96 volume remaining is then calculated 3 Sample and Reagent carousels are spun Bar codes for both reagent and samples are read If the reagent load procedure has been performed and the reagent cover has not been opened the reagent carousel is not reread 4 The on board reference cuvette is read as part of optical quality control Sample Processing The following table describes typical sample processing performed by the IMMAGE 800 Table 2 11 Sample Processing Functions Stage Description 1 Buffer is added to the reaction cuvette followed by a 5 minute incubation to allow temperature equilibrium 2 Sample or diluted sample is added to the reaction cuvette with mixing Reagent is then dispensed with mixing 4 The reaction is monitored from 90 seconds up to 5 minutes depending on the chemistry 1 of 2 IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 57 Instrument Operation Data Reduction Table 2 11 Stage Sample Processing Functions continued Description 2
393. te If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack All positions on each rack are number is entered automatically selected The Pos s field cannot be accessed A sample in a bar coded container originally programmed by entering the Sample ID or the Control ID only cannot be rerun by Rack and Position when sample is later placed in a non bar coded container The label must be recognized to rerun the sample If the Rack and Position was programmed but not scanned from the sample carousel rerun of the sample is allowed using a non bar coded container Select a button from the bottom of the dialog box When rerunning samples by Rack and Position the samples must be kept in their original rack number and position number on the sample carousel NOTICE Rerunning with Non Standard Dilutions If the original sample was programmed to run with a standard dilution and later you changed the defaulted standard to a non standard dilution the sample will be rerun with the standard dilution Sample Programming Page 7 64 IMMAGE 800 Operations Manual A11403 March 2004 Editing Sample Programs Before Rerunning 7 Introduction Editing Sample Programs Before Rerunning Introduction After samples are selected to be rerun the individual sample programs can be edited The following sample program information
394. te replicate Cal Level Setpoints Up to 6 digits with a Identifies concentration value decimal point or seven for each calibration level in digits ascending order where Level 1 is the lowest concentration value IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 77 Defining a UDR Chemistry Order of Reaction Levels Replicates Update Level Replicates Host Off Cal Level Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level 9 02 05 2004 16 49 Cal Setpoints 6 622 8 764 1 21 2 57 4 81 7 86 16 8 12 2 13 2 Enter Number of Calibrator Levels 4 9 E011419S EPS Figure 5 35 Order of Reaction Define Edit User Defined Chemistry Screen Page 3 The following table describes the order of reaction as determined by the type and volume of reaction components defined Table 5 10 Order of Reaction If the Reaction Buffer Volume is and the Compartment B Volume is the Order of Reaction is Between 195 300 uL 0 uL UDR buffer gt Incubate gt Neat or Diluted Sample gt Compartment A Reagent starts reaction Between 195 300 uL Between 5 235 uL UDR buffer Compartment B Reagent Incubate Neat or Diluted Sample Compartment A Reagent starts reaction 0 uL Between 195 235 uL Compartment B Reagent Neat or Diluted Sample gt Incubate gt Compartment A Reagent starts reaction System Setup
395. teps Table 10 3 Visual Maintenance Visually confirm that the is Wash Solution 1 volume sufficient to perform the laboratory s daily workload Each box will perform approximately 1 000 tests Blue Wash Solution tubing 2 Orange Wash Solution tubing 3 free of sharp bends or obstructions and is attached to blue fitting Refer to Figure 10 1 free of sharp bends or obstructions and is attached to orange fitting Green waste tubing 4 free of any sharp bends or obstructions and is routed to the drain or waste container If the waste is collected in a waste container 5 decontaminate according to local regulatory guidelines and empty as needed Utilities Page 10 8 IMMAGE 800 Operations Manual A11403 March 2004 Daily Maintenance Procedures Observe and Check Figure 10 1 Wash Solution and Waste Containers Observe and Check If then fluid spills are present cover spills with 10 bleach solution and wipe with an at location 1 absorbent towel Call Beckman Coulter Clinical Support 2 or 3 Refer to Figure 10 2 A010279P EPS Figure 10 2 of 2 IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 9 Daily Maintenance Procedures Cleaning Instrument Parts If then continued while priming or remove bubbles from reagent 1 and sample 2 syringes during routine syringe lines 3 tips
396. the IMMAGE 800 Immunochemistry System The control program uses the Westgard Rules to monitor statistics for up to 100 controls Rule violations 1 2S and 1 38 are flagged on a real time basis and can be displayed on the console monitor The QC program provides the following features Review Control Define Edit Delete Control QC File List e OC Log QC Summary QC Chart Levey Jennings Backup QC Print Control Recommended QC and Analysis Intervals Beckman Coulter recommends that at least two levels of control material be analyzed daily In addition these controls should be run with each new calibration with each new lot of reagent and run after specific maintenance or troubleshooting as detailed in CHAPTER 10 Utilities More frequent use of controls or the use of additional controls is left to the discretion of the user based on individual laboratory practice QC Data Source The system allows the operator to review and print QC data stored on Hard Disk External Media Floppy Diskettes Additional Information Refer to APPENDIX C Reports for a QC Report Sample 1 Wesigard J O Barry P L Hunt M R Groth T A A Multirule Shewhart Chart for Quality Control in Clinical Chemistry Clinical Chemistry 1981 27 493 501 Also http www westgard com pdf Quality Control IMMAGE 800 Operations Manual A11403 Page 9 2 March 2004 QC Statistics and Rules Introduction QC Statistics and Rule
397. the Stop bit Symbology bar code A set of rules for encoding and decoding information contained in a bar code symbol Examples of symbologies are Code 39 Code 128 Codabar and Interleaved 2 of 5 Target value The known concentration of a calibrator Unidirectional interface One way communication Results are communicated from the instrument to the host computer only Unit category An expression of concentration such as weight volume e g mg dL mass volume e g mol L and International Units volume e g IU mL Glossary IMMAGE 800 Operations Manual A11403 Page 6 of 6 March 2004 Index A C ACGCUIACy s soo Meee de ea ta 9 4 9 22 Calculations screen 0 0c cee eee eee 5 30 Action log 1 et Bea re 9 22 9 25 9 31 Calculations summary screen 4 5 30 Add del chem control chem 0005 9 14 Calculations Beckman Coulter defined 5 28 Adding samples to an operating instrument 1 7 Editing variableS oooooooomoo o 5 33 Advance buttoN ooooocooocooocooo ooo 2 11 7 7 Excretion rate calculations 5 31 After calibration o ooooooooommooo 6 34 UnitS scales BAe a at 5 29 After loading buffers and diluents 6 11 Calibration curve 0 eee 3 12 AGXS Testing 0 cee eee eee eee 5 42 Calibration report nanasa aaaea eee 6 34 Alb min ALB re aa a R R pud 3 8 Calibration request
398. the revised constituent code beside the chemistry it corresponds to in the Constituent Code field 4 alphanumeric characters type leading zeroes if they are part of the constituent code 5 Select Control ID F2 6 Enter the revised control ID into the Control ID field Up to 15 alphanumeric characters per field At least one Control ID and up to 8 different control IDs may be defined for each control name 7 Select OK to save the Control IDs OR Select Cancel to return to the Define Edit Controls screen without saving the Control ID 8 Select any icon from the menu bar to exit the Define Edit Controls screen and save the edited control definition 2 of 2 IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 13 Editing a Control Adding or Deleting Individual Chemistries Adding or Deleting Individual Chemistries Follow the steps below to add or delete an individual chemistry definition from a control definition Step Action 1 From the Quality Control screen select the button beside the control name to be edited Select Define Edit F2 Select Add Del Chem F1 aj AI II N Select the button beside the chemistry to be added or deleted If deleting a chemistry without If deleting a chemistry with results results Select OK to delete the Select OK to delete the results chemistry from the control cumulative statistics
399. the run Refer to CHAPTER 6 Reagents Calibration Loading Clearing Buffers and Diluents for more information Sample Programming Page 7 8 IMMAGE 800 Operations Manual A11403 March 2004 Checking Wash Solution Volume Introduction Checking Wash Solution Volume Introduction Before starting a run the wash solution should be checked to ensure that there is sufficient volume to complete the run Each wash solution box will perform approximately 1 000 tests The instrument also has an internal reservoir of wash solution so a run can continue for a short time after the box is empty however the box should be replaced as soon as possible Checking Wash Solution Follow the steps below to check the wash solution volume Step Action 1 Visually inspect the wash solution level through the perforated cut outs at the top of the box and or lift and swirl the box Replace the box if the wash solution volume does not appear sufficient to complete the run Refer to CHAPTER 6 Reagents Calibration Loading Wash Solution for more information Wash solution can be pooled For a more accurate estimation of wash solution usage record the cycle count when a new wash solution box is placed on the system Replace the box when the cycle count nears 1 000 additional tests NOTICE Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 9 March 2004 1 Overview
400. ther chemistries calculations OR Select any icon from the menu bar to exit the screen Deleting a Line 2 of 2 This function is used to delete one line of a chemistry calculation interval and range definition The instrument status must be in Standby in order to proceed with the steps below to delete a line from an interval and range definition for a chemistry calculation Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 Select the button beside the chemistry calculation where a line is being deleted Select lt Define Edit gt Refer to Figure 5 7 Select a field on the line being deleted Select Delete Line F2 D ny AJO Select lt OK gt to delete the intervals and ranges OR Select lt Cancel gt to return to the Reference Interval Critical Ranges screen without deleting the line IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 23 Reference Interval Setup Printing Intervals and Ranges Printing Intervals and Ranges When the instrument status is in Standby proceed with the steps below to print the interval and range definitions Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation to be printed Multiple chemistries calculations can be chosen 3 Select Print
401. tient ID is the demographic information with demographic entered later for a will be displayed information for a sample new sample automatically for the new sample the patient name will appear in the Patient Name field Entering a Patient ID Follow the steps below to enter a Patient ID Step Action 1 Select Samples from the menu bar 2 Choose the Patient ID field 9 Type a Patient ID up to 15 alphanumeric characters Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 24 March 2004 Entering Patient Demographics 7 Introduction Entering Patient Demographics Introduction Patient Demographics can be entered for each sample Select Demog F2 to access the Demographics screen The upper section of the Program Sample screen also appears on the Demographics screen Refer to Figure 7 6 Only the STAT check box and the Sample Type and Sample Comment fields can be accessed Individual patient demographic fields can be disabled from Setup Disabled demographic fields cannot be accessed 87 16 1996 13 44 Sample Status Not Programmed Sample Type i sm qme i LL pesi a yj Doctor Location Lastname Firstname MI e 1 Collection 07 18 96 sex wr mm dd yy we Date tom dd yy z Collection Time hh m Patient Comment ye ees Program Sample EL Enter Patient ID E010256S EPS Figure 7 6 Demographics Screen IMMAGE 800 Ope
402. tion when using small volumes of sample in sample cups To minimize evaporation Program samples in positions A or B on the sample carousel OR Program samples as STATS 2 mL placed into a sample cup holder 0 5 mL placed into a sample cup holder IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 49 Bar Code Types and Options Introduction Bar Code Types and Options Introduction Four bar code types are supported by the IMMAGE 800 Code 39 Code 128 nterleaved 2 of 5 Codabar The bar code scanner will read any of these bar code types provided the type is enabled in Bar Code Setup and the options match those defined for the bar code label The scanner will also automatically discriminate between the symbologies so tubes with bar code labels of different types may be intermixed in a run Code 39 Options Check Digit If a higher degree of data integrity is required a check digit may be enabled and added to the bar code ID The check digit used is a Modulus 43 which is the sum of all the character values and is the last digit of the bar code ID Code 39 expects the check digit to be included in the final code length Large Intercharacter Gap In Code 39 the intercharacter gap has a minimum value of one times the width of the narrow element and a maximum value of three times the width of the narrow element or 0 06 inches 0 152 cm whichever is greater This feature sho
403. tions in this chapter for more information Sample Programming Page 7 46 IMMAGE 800 Operations Manual A11403 March 2004 Entering Editing a Batch Sample Program 7 Editing Samples Within a Batch Editing Samples Within a Batch Individual samples within a batch can be edited after the batch samples are identified Editing can include entering patient demographic information Follow the steps below to edit an individual sample within a batch Step Action 1 Select Samples from the menu bar 2 Type the Rack number and Position number OR Type the Sample ID of the desired sample Edit the desired information for the sample 4 Select Save Next F10 Repeat Steps 2 4 to edit additional samples IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 47 Identifying Batch Samples Introduction Identifying Batch Samples Introduction After a sample program is entered for a batch the samples in the batch must be identified The procedure for identifying samples in a batch is different when Bar Code Priority is enabled in Setup than when Bar Code Priority is disabled Identifying Batch Samples Bar Code Priority Enabled Follow the steps below to identify which samples are to be included in a batch if bar code priority is enabled in Setup Step Action 1 Select Program Batch F4 when all information to be applied to the batch is programmed 2 Type the Sample
404. tions Manual A11403 March 2004 Variables Calculations Setup Variables An IMMAGE 800 variable is a placeholder which may represent more than one number A maximum of six variables may be defined for use in Custom Calculations The numeric value for a variable is assigned during sample programming and that value will be used for the Custom Calculation on that particular sample Refer to CHAPTER 7 Sample Programming Setting Variables Defining and Editing Variables The instrument status must be in Standby in order to proceed with the steps below to define or edit variables Step Action 1 From the Setup screen select 6 Calculations OR Enter 6 in the Option No field 2 Select Define Var F5 3 Enter the Variable name in the Define Variables fields A maximum of six variables may be defined with up to five alphanumeric characters NOTICE Variable names cannot begin with a numeric character 4 Select OK to save the variable name OR Select Cancel to return to the Calculations Summary screen Custom Calculations A Custom Calculation name must be unique with a maximum of 15 characters Calculation formulas are not affected if the operator deletes the chemistries from the Chemistry Configuration The operator must enable or disable each Custom Calculation individually If the sample type defined for a calculation is serum the calculation is applied to samples with a sample ty
405. tions Manual A11403 Page 5 58 March 2004 Default Setup Setting the Default Post Run Summary Time Search Setting the Default Post Run Summary Time Search The instrument status must be in Standby in order to proceed with the steps below to set the time limit for the Post Run Summary Step Action 1 From the Setup screen select lt 11 gt Default Setup 2 Select the options button lt W gt beside Post Run Summary Time 3 Select the number beside the desired time search option OR Enter the number of the desired time search in the Option No field and press Enter OR Select Cancel to return to the Default Setup screen without changing the Post Run Summary Time search The default Post Run Summary time has no time restriction 4 Select lt OK gt to return to the Setup dialog box and change the Post Run Summary Time Search OR Select Cancel to return to the Setup dialog box without changing the Post Run Summary Time Search Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore replicate statistic defaults Step Action 1 From the Setup screen select lt 11 gt Default Setup Refer to Figure 5 22 2 Select lt Restore Default gt The defaults are Default Sample Type serum System Replicates 1 Post Run Summary Time none 3 Select lt OK gt to restore defaults OR Select lt Cancel gt to return t
406. tions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host 5 Select a function button from the bottom of the screen 6 Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results Results Recall IMMAGE 800 Operations Manual A11403 Page 8 8 March 2004 Recalling Results by Run Date Time Introduction Recalling Results by Run Date Time Introduction Results can be recalled by Run Date Time Recalling by Run Date Time Follow the steps below to recall results by Run Date Time Step Action Select Results from the menu bar Refer to Figure 8 1 2 Enter the desired date and time ranges in the From fields and To fields Refer to Table 8 1 Select the options button lt W gt beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host 5 Refer to Displaying Recalled Results on the Screen and Printing a Recalled Result in this chapter to display or print results IMMAGE 800 Operations Manual A11403 Results Recall
407. to be included in the Inter Lab QC Summary Accessing the QC Summary Follow the steps below to access the QC Summary Step Action 1 From the Quality Control screen select the control desired Use the lt Page Up gt lt Page Down gt buttons to access additional controls Select QC Summary F6 from the Quality Control screen Refer to Figure 9 8 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select lt OK gt to choose the default Use Tab to toggle between fields Select lt OK gt to continue OR Select lt Cancel gt to exit Select Print F10 to print the QC Summary OR Select Inter Lab F9 to print a QC Summary report in the Inter Lab format Additional information Refer to CHAPTER 5 System Setup Report Setup Defining Inter Lab Information for information on setting up a Inter Lab reference number and contact person for the Inter Lab QC Summary IMMAGE 800 Operations Manual A11403 Quality Control March 2004 Page 9 27 Displaying QC Summaries Additional information Main Samples Besults Rats Cal QC Summary Start End Date Date January 26 1998 March 26 1998 fissigned Summary Chem Mean SD N Mean SD c3 25 8 255 3 1 742 c4 61 5 5 5 58 34 8 7273 March 26 n Utils Status Stop F12 About Control Lotit Sample Tupe M612143 Serum Cumulative Summary CU N Mean SD Cu 8 7 18 271 6
408. to clear intervals and ranges from the Reference Interval Critical Ranges dialog box Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation to be cleared Multiple chemistries calculations can be chosen Select Clear Ranges 4 Select lt OK gt to clear all the intervals and ranges for the chemistry ies calculation s selected OR Select Cancel to return to the Reference Interval Critical Ranges dialog box without clearing intervals and ranges IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 21 Reference Interval Setup Inserting a Line When the instrument status is in Standby proceed with the steps below to clear intervals and ranges from the Reference Interval Critical Ranges screen Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation to be cleared Multiple chemistries calculations can be chosen Select lt Define Edit gt Refer to Figure 5 7 4 Select Clear Ranges F3 Select lt OK gt to clear the intervals and ranges for the chemistry calculation sample type and sex selected OR Select lt Cancel gt to return to the Reference Interval Critical Ranges screen without clearing intervals and ranges 6 Select another sample type and or sex
409. to move to other definitions within the same chemistry calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 to move to other chemistries calculations Repeat Steps 4 5 OR Select any icon from the menu bar to exit the screen Inserting a Line This function is used to insert one line in a chemistry calculation interval and range definition The instrument status must be in Standby in order to proceed with the steps below to insert a line into an interval and range definition for a chemistry calculation Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation where a line is being inserted Select lt Define Edit gt Refer to Figure 5 7 4 Select a field on the line below where a line will be inserted Select Insert Line F1 A blank line will be inserted 1 of 2 System Setup IMMAGE 800 Operations Manual A11403 Page 5 22 March 2004 Reference Interval Setup Deleting a Line Step Action continued Type ages age units intervals and ranges on the blank line Use the Page Up or Page Down buttons to move to other pages of the same chemistry calculation Select another sample type and or sex to insert lines from additional groups of the chemistry calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 to move to o
410. try System is the HP DeskJet printer The printer is designed to use single sheet paper The printer is set up to use 8 5 x 11 inch paper Paper size can be chosen in Printer Setup Refer to the manual that accompanies the printer for proper setup care and handling of the printer IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 25 Overview Introduction Software Overview Overview Introduction The IMMAGE 800 is controlled through a graphical user interface GUI This section describes the basic functions within the interface The concepts presented in this section should be understood by the user before attempting to use the IMMAGE 800 The Main Software screen is shown below Host Off 02 05 2004 15 37 Stop F12 Version 2 8 84 EFL Stop Home Pause Run Select an option E011433S EPS Figure 2 16 Main Screen System Description IMMAGE 800 Operations Manual A11403 Page 2 26 March 2004 Screen Format Introduction Screen Format Introduction The IMMAGE 800 Immunochemistry System is designed to have a user friendly interface Figure 2 17 shows the sample programming screen of the IMMAGE 800 as an example of this interface This screen is broken into six functional areas Status Bar Menu Bar Title Bar Function Buttons Message Bar Working Area Host Off Patient Serum Zi Patient EA Name e Control Demog Sample Program Select Rerun Clear PostRun Load Saw Batch Option
411. u bar 2 Select Run Additional Information Refer to CHAPTER 2 System Description for information on how the IMMAGE 800 processes a calibrator and for test tube and sample cup sizes Refer to CHAPTER 3 Theory of Operations for the theory of calibration IMMAGE 800 Operations Manual A11403 Reagents Calibration March 2004 Page 6 33 Calibration Results Introduction Calibration Results Introduction The following information may be printed on the Calibration Report for a successful calibration result Refer to APPENDIX C Reports for an example report Chemistry ID Chemistry Lot Calibrator ID Reaction Buffer Lot e Sample Diluent Lot Date and Time of Calibration Units nstrument Response Target Response Cal Value Dilution Rack Position of the calibrator Reagent Position STAT Rerun flags Instrument Errors Codes Calibrated to Value Calibration Time Limit No time limit is imposed by the system for expiration of a calibration result Recalibration of affected reagents may be necessary when reaction buffer or diluent lots are changed Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual After Calibration Rack positions used for calibration are automatically cleared to a status of Available after the calibration is run whether the calibration passed or failed Failed Calibration When calibration fails e Samples programmed for a re
412. ual A11403 March 2004 Alignment Sample and Reagent Crane Probe Height Depth Step Action continued Complete Steps 1 3 as described on the screen selecting Continue after performing each step OR Select Stop to exit Select Close to return to the Alignment screen or select Repeat to restart the alignment procedure Select Yes from the Alignment dialog box to save the alignment data to a temporary file OR Select No to return to the Alignment Reagent Crane Probe screen without saving the alignment data Select any icon from the menu bar Refer to Figure 10 31 Select Yes from the Alignment dialog box to save the new alignment data to the database F1 Prev Align allows the operator to overwrite this alignment data with the previous alignment data OR Select No to restore the previous alignment data 2 of 2 Do you want to save the Alignment data No E014080S EPS Figure 10 31 Alignment Dialog Box IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 61 Alignment Optics Alignment Optics Alignment Follow the steps below to perform the Optics Alignment Step 1 Action Select Utilities from the menu bar 2 Select lt 4 gt Alignment OR Enter 4 in the Option No field and press Enter Use the Page Up and Page Down buttons to view additional Utilities options Select 11 Optics from the Functional
413. uld be enabled when the intercharacter gap exceeds four times the narrow element width Fixed Code Length If the sample IDs being used are all of the same length Fixed Code Length may be enabled to ensure that only one length of sample ID is accepted Define Code Length When Fixed Code Length is enabled the code length may be defined as from 1 to 15 characters Code 128 Options The options for Code 128 bar codes are fixed in the software and cannot be reconfigured by the user The IMMAGE 800 uses Code 128 formatting to read BECKMAN COULTER bar coded cards and rack ID Fixed Code Length disabled System Description IMMAGE 800 Operations Manual A11403 Page 2 50 March 2004 Bar Code Types and Options Interleaved 2 of 5 Options Interleaved 2 of 5 Options Check Digit If a higher degree of data integrity is required a check digit may be enabled and added to the bar code ID The check digit used is a Modulus 10 Interleaved 2 of 5 expects the check digit to be included in the final code length Code Length One An even number from 0 to 14 must be defined as the number of characters in the code Code Length Two A second code length an even number from 0 to 14 may be defined Both lengths would then be recognized Codabar Options Start and Stop Codes Match When this option is enabled the start code and stop code must be the same character for a valid read Large Intercharacter Gap This option is used when rea
414. ults from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host Select a function button from the bottom of the screen of 2 IMMAGE 800 Operations Manual A11403 Results Recall March 2004 Page 8 5 Recalling Results by Rack and Position Recalling by Rack and Position Step Action continued 7 Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results 2 of 2 Results Recall Page 8 6 IMMAGE 800 Operations Manual A11403 March 2004 Recalling Results by Patient ID Introduction Recalling Results by Patient ID Introduction Results can be recalled by Patient ID or by Control ID Recalling by Patient ID Follow the steps below to Recall a result by Patient or Control ID Only one Patient or Control ID may be requested at a time Step Action 1 Select Results from the menu bar Refer to Figure 8 1 2 Enter the Patient or Control ID up to 15 alphanumeric characters in the Patient ID field Select the options button lt W gt beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes th
415. ument problems initiating appropriate solutions for problems identified This section explains how to use Error messages for troubleshooting Event Log Callable Diagnostics alignment backup restore internal wash bottle fill touch screen calibration Utilities IMMAGE 800 Operations Manual A11403 Page 10 2 March 2004 Overview Replacing Parts User Servicing Replacing Parts User Servicing For help with any system issues call Beckman Coulter Clinical Support The following information will assist the troubleshooting process the model number part number or serial number of the affected system and diagnostic printouts containing full details of the difficulty encountered IMMAGE 800 Operations Manual A11403 Utilities March 2004 Page 10 3 Recommended Tools and Supplies Beckman Coulter Tools and Supplies Maintenance Recommended Tools and Supplies Beckman Coulter Tools and Supplies The following items can be acquired from Beckman Coulter Inc Table 10 1 Beckman Coulter Tools and Supplies Item Part Number Maintenance Logbook 962324 IMMAGE Optics Wash Head Alignment Tool 970456 Additional Tools Supplies The following items should be available in the laboratory Straight slotted screwdrivers Phillips head screwdrivers Allen wrench 9 64 inch Isopropyl alcohol swabs Household bleach solution Cotton tipped applicators Deionized water Paper towels Lint free tissues
416. unavailable and the instrument must be stopped immediately NOTICE When an emergency stop or unplanned power loss occurs during a run and power is restored within 24 hours the cuvettes must be washed 1 time before a run can be started Refer to CHAPTER 10 Utilities As Indicated Maintenance Washing Cuvettes If power is restored after 24 hours the cuvettes must be replaced Refer to CHAPTER 10 Utilities As Indicated Maintenance Replacing Cuvettes System Power On Off Page 4 4 IMMAGE 800 Operations Manual A11403 March 2004 Database Recovery Introduction Database Recovery Introduction In the event of a fatal system error or power outage the system will attempt to recover files and databases which may have been affected Fatal Errors When a fatal error note is displayed call Beckman Coulter for assistance Information Retained The following information will be retained in the database after power is restored Chemistry protocols Reagent and calibrator bar coded parameters Current calibration status for each reagent Calibration requests that were not completed Completed results e Sample programming for incomplete results and samples that have not been run Quality control files All system software setup configurations Event logs All instrument hardware settings Information Changed The following information and or screens will be changed after power is restore
417. ure 5 22 2 Select options button lt W gt beside Default Sample Type 3 Select the button beside desired default sample type from the choices below Serum e CSF Plasma Random Urine Timed Urine The default is serum The selection will be shown in the Default Sample Type field Select OK to return to the Setup dialog box and change the sample type OR Select Cancel to return to the Setup dialog box without changing the sample type IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 57 Default Setup Definition of Replicates Default Setup Default Sample Type System Replicates 1 Post Run Summary Time None 7 Restore Default ae Som E014092S EPS Figure 5 22 Default Setup Dialog Box Definition of Replicates System Replicates The number of times each test will be performed on each sample Setting System Replicates The instrument status must be in Standby in order to proceed with the steps below to set the desired number of system replicates Step Action 1 From the Setup screen select lt 11 gt Default Setup Refer to Figure 5 22 2 Type the desired number of system replicates 1 to 9 in the System Replicates field 3 Select lt OK gt to return to the Chemistry Configuration screen OR Select lt Cancel gt to return to the Chemistry Configuration screen without changing the statistics setup System Setup IMMAGE 800 Opera
418. uses the following printed and visual cues to guide the user in how to respond to printed directions Table 1 1 IMMAGE 800 Conventions Convention Description Icon Buttons Icon buttons are in bold with one letter underlined The underline indicates which letter to press in combination with the Alt key to select the icon button from the keyboard Function Buttons F1 Function buttons are in bold with the corresponding function key in square brackets Buttons The less than and greater than 2 symbols enclose a button s name in bold Options button W The less than lt and greater than gt symbols enclose a black triangle preceded by the phrase options button all in bold Text field Names of text fields are followed by the word field all in bold X or Tab Alt X Keyboard keys are in bold and enclosed by square brackets Combination keys are in bold and enclosed by square brackets with a plus between each key Manual Format Information in this manual is presented in modular units Each unit of information is described by a brief title in the left margin Many units consist of a table which presents a procedure process or description IMMAGE 800 Operations Manual A11403 March 2004 General Information Precautions and Hazards Page 1 3 How to Use This Manual Procedure Tables Procedure Tables Pr
419. utton to rotate the carousel to additional positions Racks containing calibrators must be placed in sample carousel positions A and or B only A012102L EPS Figure 7 16 3 of 3 IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 53 Pre run Checklist Pre run Checklist Pre run Checklist Pre run Checklist With the IMMAGE 800 in Standby prepare for the start of a run by performing these tasks or verifying they have been performed Refer to appropriate sections of this guide for instructions on how to perform each task Perform daily maintenance Check status of dilution segments clear and replace if necessary Check status of reagent cartridges load if necessary Check status of reaction buffers and sample diluents replace if necessary Check sample rack status clear racks if necessary Check calibration status calibrate 1f necessary Prepare sample containers Program control or patient requests if necessary Load samples Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 54 March 2004 Starting the Run Starting the Run When all sample racks are on the sample carousel and the run is ready to be processed follow the steps below Step Action 1 Close the covers Select Main from the menu bar 2 3 Select Run 4 Select OK if dilution segment status is OK AND Observe the instrument occasionally during the
420. ver with respect to such sample and reagent performance including sample carryover test results reagent and cartridge handling their effect on the system or required system maintenance or the frequency thereof or their effect on operator safety User assumes full responsibility for use of the proper test protocol and test result generation for the reagent s selected by the user and for any errors or omissions associated therewith BECKMAN COULTER EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THIS PRODUCT WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AN CAUTION Non Beckman Coulter reagents calibrators and controls can contain components not listed on the insert which may carry over into the system causing chemical or optical interference This carryover could adversely affect results on a properly performing system Manufacturers of user defined reagents should be contacted for disclosure of potentially interfering substances such as preservatives System Setup IMMAGE 800 Operations Manual A11403 Page 5 68 March 2004 Setting Up a UDR Chemistry Loading the Protocol Diskette Setting Up a UDR Chemistry Loading the Protocol Diskette Follow the instructions under Loading the Chemistry Protocol Diskette earlier in this chapter to load the user defined reagent chemistry protocol templates Password Setup Procedure Once a UDR chemistry has been define
421. w to rerun original sample programs Step Action 1 Select Rerun Samples F6 from the Program Sample screen and select samples to be rerun Refer to Rerunning a Sample Selecting Samples to be Rerun in this section for more information 2 Select Rerun Samples The Rerun Samples dialog box will close and the Program Sample screen will appear IMMAGE 800 Operations Manual A11403 Sample Programming March 2004 Page 7 67 Rerunning Selected Chemistries Introduction Rerunning Selected Chemistries Introduction Through Rerun Chem one or more chemistries can be selected for all samples which are to be rerun The samples will then be programmed for only those selected chemistries Only a chemistry which was selected in the original sample program can be selected in Rerun Chem The ability to add a new chemistry is only available through Edit Samples Selecting Chemistries for Rerun Follow the steps below to select chemistries to be rerun Step Action I Select Rerun Samples F6 from the Program Sample screen and select samples to be rerun Refer to Rerunning a Sample Selecting Samples to be Rerun in this section for more information 2 Select lt Rerun Chem Select the chemistry s to be rerun Refer to Figure 7 21 Refer to Programming a Sample Selecting Chemistry Tests by Chemistry in this chapter for more information 4 Select lt OK gt to run the chemistry s
422. wer off The status of the battery is checked every time the Power On sequence is performed A CAUTION The date and time must be reset each time the Power On sequence is performed on a computer with a dead CMOS Complementary Metal Oxide Semiconductor battery Contact Beckman Coulter Clinical Support or the nearest local Beckman Coulter Field Service office for assistance in replacing the battery IMMAGE 800 Operations Manual A11403 System Description March 2004 Page 2 21 Computer Changing the Date on the PC Table 2 7 Computer Components Number Component Description 1 Personal Computer The PC contains the PC CPU Central Processing Unit hard disk drive floppy diskette drive CD ROM Drive 2 Floppy Diskette Drive Where a 3 5 inch floppy diskette is placed and read 3 CD ROM Drive Where a CD ROM is placed and read 4 Keyboard 101 key enhanced keyboard 5 Mouse A two button movable input device 6 Monitor Displays user interface touch screen 7 Uninterruptible Power The backup power source providing temporary Source UPS power to the computer for a limited period of time in the event of brownouts or low line voltage conditions System Description IMMAGE 800 Operations Manual A11403 Page 2 22 March 2004 Keyboard Computer Keyboard Figure 2 14 depicts the 101 key enhanced keyboard used on the IMMAGE 800
423. x System Setup IMMAGE 800 Operations Manual A11403 Page 5 64 March 2004 Language Setup Introduction Language Setup Introduction A language can be selected for use for system operations and printouts on the IMMAGE 800 The keyboard should match the language Changing the Displayed Printed Language The instrument status must be in Standby in order to proceed with the steps below to change the language Step Action 1 From the Setup screen select lt 15 gt Languages Keyboard Refer to Figure 5 26 2 Select a language from the options button lt V gt NOTICE Selecting Japanese from the Language options will cause the Language Keyboard selection to become unavailable Reloading of the software is necessary to restore the Language Keyboard Selection option OR Select lt Cancel gt to return to the Setup screen without changing the language 3 Perform the power off sequence and then the power on sequence Refer to CHAPTER 4 System Power On Off Power On Sequence Power Off Sequence Language Keyboard Selection Language English USA OK Cancel E010232S EPS Figure 5 26 Languages Keyboard Selection Dialog Box IMMAGE 800 Operations Manual A11403 System Setup March 2004 Page 5 65 Loading the Chemistry Protocol Diskette Description Loading the Chemistry Protocol Diskette Description The chemistry protocol diskette is provided with each IMMAGE 800 Immuno
424. y calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 to move to other chemistries calculations Repeat Steps 4 5 OR Select any icon from the menu bar to exit the screen System Setup Page 5 20 IMMAGE 800 Operations Manual A11403 March 2004 Reference Interval Setup Deselecting a Default Deselecting a Default When the instrument status is in Standby proceed with the steps below to deselect the default interval and range Step Action 1 From the Setup screen select lt 4 gt Reference Interval Refer to Figure 5 7 2 Select the button beside the desired chemistry calculation Multiple chemistries calculations may be chosen Select lt Define Edit gt Refer to Figure 5 7 4 Select a field on the interval range line that is the current default Select Select Default F3 The gt symbol is removed from the far left of the line 6 Select another sample type and or sex to move to other definitions within the same chemistry calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 for other chemistries calculations Repeat Steps 4 5 OR Select any icon from the menu bar to exit the screen Clearing Intervals Ranges Intervals and ranges can be cleared from either the Reference Interval Critical Ranges dialog box or the Reference Interval Critical Ranges screen When the instrument status is in Standby proceed with the steps below
425. zi N E pa pi Rmi Rx kya kyi Vr sha sya Fr T4 cha tya tyi cyi cya Z 4 nya nvi Ex Es bya byi aT 74 fa fi J rya vid f A I Figure 7 33 7 x a u e o A y su se so Xx T 7 nu ne no La A mu me mo JL L n ru re ro Z 7 d gu ge go J Ty F du de do TJ E pu pe po 3 kyu kyo va Dr a shu syu she sye sho syo Fa Tr Ta chu tyu che tye cho tyo cyu cye cyo 1 3 nyu nyo Ea Er Ea byu bye byo 7r aa fe fo Ya Ya ryu ryo 3J x U E 9 IN ha ya wa A ba Fe gya Te ja Tv dya Ev hya Ex pya mya ki F chi ti E h 74 wi J E bi gal Egyl Fa di dyi Ex hyi Ex pyi z myi 9 ku Y tsu tu 2 hu fu 1 yu Xa gyu Ya ju Fa dyu Ea hyu Ez pyu 1 myu y TSU TU tt ss kk pp tc Katakana Conversions From Romaji Tr dve Er hye YA Xa gyo za jo Fa dyo Ex hyo Ex pyo myo a YU J015153L EPS Sample Programming Page 7 98 IMMAGE 800 Operations Manual A11403 March 2004 CHAPTER 8 Results Recall Table of Contents Results Recall 352 225 n tddi 8 2 vedi Jem b 8 2 Recalling Results by Sample ID 5 sione e eR Oso nates t qo ie inre 8 3 Recalling Results by Rack and Position i i eos es teet edocet decade ede 8 5 Recalling Results by Patent 1D os aah see vase Uv eae NI AE tna UE ee EAR eU 8 7 Recalling Results by Patient Nate de ettet tente deant et ee

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