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HumaStar 300

1. Diagnostics Worldwide 5 3 4 Testing Procedure The Module has to be calibrated daily together with the other components 1 Cal B approx 400 ul in a sample cup should be placed on the Calibration Rack 2 Place daily also 400 ul of Clean S solution in its position 3 Select to Calibrate the ISE it requires about 2 min a Clean S solution will be aspirated to clean and rinse the electrodes b Followed by purging several times the electrodes with Cal A reagent c It calibrates the electrodes with Cal A the first calibration point d It aspirates the Cal B twice to calibrate the second point e The Analyzer checks that the 2 calibration points are correct according to the preset values in the system an OK will be displayed f Should the calibration fail for one of the electrolytes there will be displayed a message The calibration has to be repeated g For further information see the Maintenance Program h If Quality Control is desired include a Serum control during the Calibration Note If the calibration of one of the parameters failed the system will print a next to this parameter The determination of all the tests will proceed the parameter that failed the calibration and if not repeated will use the data saved from the previous calibration 5 3 5 Urine Tests If there are Urine samples to be analyzed these have to be first pre diluted 1 10 with its proper diluent Use the Prepper In any case
2. ISEo ISE Out Range RPL Error in the triplicate Standard Calibration 4 8 2 Sample Pre dilution In routine testing a 3 ul sample is normally used Even in the case of Automatic Repetition of Result a 1 5 ul is used and gives perfectly acceptable results However automatic Pre dilution of sample can be used for any method that may require it or in the case of small volumes or pediatric samples that may need it The sample Pre dilution should be programmed in the Method and executed before the start of routine testing The sample Pre dilution should be done on both the Samples and their Standards and Calibrators When doing Pre dilution make sure that for every sample there is an empty pre dilution cup Make sure that there is a full bottle with pre dilution liquid under the Sampling Arm Make sure to select the Dilution Ratio before Start There is only one pre dilution Ratio possible with each run If there are more then ONE pre dilution ratio necessary in a Worklist the other tests will have to be done on a separate run Urine for ISE remember that all Urine samples have to pre diluted 1 10 prior to testing In case the analyzer is stopped and new samples have been added that require pre dilution these will be automatically pre diluted when START is given Human I A Diagnostics Worldwide 57 58 Human HumaStar 300 User Manual 5 Bar Code Reader Ise Module Data Exchange Both the Bar Code Reader as well
3. 8 Clear Page to delete all results without saving 9 Save and Clear all Samples 10 Repeat all Samples that have been programmed 11 Clear all Samples delete all samples without saving 2 7 _ Navigation The following commands are available Human L zeg Diagnostics Worldwide 23 Ele Edit Graph Navigation 2 y Previous page Newt Page Samples Previous Section ao ae 3 in ie 2 2 Close Register 23 2 A 24 2 de 25 2 26 21 2 7 1 24 Human HumaStar 300 User Manual 2 8 Help The following commands are available File Edt Graph Navigation 2 Help Tell me How Help What s this About Sar Pos 21 22 23 24 Di 26 2 8 1 2 9 Analyzer Status In part 3 ofthe Main Menu there are 3 icons that identify the Analyzer Status 1 START when this icon is green the analyzer is READY to execute a command To START click onthe green triangle When the triangle is gray the analyzer is in operation and cannot accept a new command 2 STOP Intelligent Enables to STOP the analyzer during operation without disturbing the E operational cycle There are two colours possible RED analyzer is operating and cannot accept other commands GREY analyzer cannot accept any command 3 Alarm When illuminated indicates the presence of an ERROR or FLAG Click on the ICON to A open a window to display the error message 4 Arrow close to th
4. To run a check click on its CHECK BOX e then click START The analyzer will perform the requested operation an OK will be displayed and the time of operation Wait for the green light START to be ON before requesting the next operation ISE MODULE CHECK In case of difficulty during Calibration before repeating try the suggested procedure below 1 Run twice the ISE Clean cycle fill the sample cup with the Clean solution and place it into its position 2 Run 3 times the ISE Purge cycle Then repeat the Calibration If the problem persists call technical assistance For additional details see description in Chapter 5 72 Human HumasStar 300 User Manual 6 3 Measurement System From the Main Menu click on F8 MAINTENANCE All Auto checks are indicated OK as shown below Ele Edt Graph Navigation 2 Measurement System Set Acton Time Instrument On Line 11 20 Int Hardware Fil Hydraulics Waste Tank Level Wath Tank Level Ine Liquid Level Test Level Bath Drain Bath Fil Incub Bath Wash All Cuvettes Clean All Cuvettes Read Temper C Read Al Fitters Read 340 nm Read 380 nm Read 405 nm 2 Read 510 nm Read 546 nm Si Read 578 nm 11 20 11 20 11 20 11 20 11 20 11 20 Ready A E 11 49 42 AM AutoCheck OK 6 3 1 Measurement System How to use the above program To run a check click on its CHECK BOX e then click START The analyzer will perform
5. Click F6 and the Book will open to all available programmed Standards and Calibrators The standards are arranged in alphabetical order on the right Each programmed standard or Calibrator has its own page which displays the name of the standard its concentration the absorbance measured or its calculated Factor and the date of its last calibration There are no limits of the number of Standards that can be programmed To Program a new Standard click on Edit and again on Insert Page to open a window Introduce the name of the new Standard and click OK A new page will be added for the Standard book Click on the first line with the asterisk to open the opposite page displaying all the available programmed methods Click the check box of the method corresponding to that Standard and click again on Reference line below to introduce the concentration value for that standard The same standard solution may be used for more than one method A multi Calibrator with all the substrates can be programmed the same way Introduce the concentrations for each of the methods one at a time To change the concentration value of a standard highlight it and change its concentration value on the Reference line To Delete a standard simply highlight it and press Delete on the keyboard A confirmation window will open choose Yes or No accordingly TO PROGRAM A MULTI STANDARD OR CALIBRATOR make sure to open a separate page for each concentration level as de
6. Onthe monitor all 40 positions are coloured White free positions 8 Inside the Figure are displayed the Free positions in White and the others as follows Yellow Position Accepted Green Sample Identified Red Sample NOT Identified White Free Position Es Aeoistere Dion 7 162817 6009900 D A O O en 10 10 Simpie NOT ienned oO Re a C Actepted Poskions 41 2016 4 E 90656009 5 1 2 3 To Assign Sample Positions 60 Human HumaStar 300 User Manual Sample not identified maybe dueto Missing Sample Bar Code not readable No Bar Code present All identified samples their positions become GREEN 9 Click on Accepted Posit To transfer its work list and the position becomes Yellow position accepted 10 The non identified Samples become Not assigned These can be assigned manually by Drag and Drop or click on Assign Manual 11 In both cases the positions become first green and the yellow To exit back to the Main Menu click Cancel See Fig 5 1 2 4 09 20 2001 152928 Fle Beyim Dot Sample Rack Load Free Postions Sample Kertifund Sample NOT Meretiod Accepted Posimons 5 1 2 4 To Accepted Sample Positions 5 2 Reagent Identification To identify the Reagents in their correct position as programmed on the Reagent ON Line Page 1 From the main Menu click F9 OPTIONS and activate Reagent Bar Code Identifica
7. first turn plate gt Inc Time 1 Read Time 4 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 variable Example 62 sec or any other time from the table 5 Measure Sample M2 First Measurement 6 Read Time 78 sec or any other time Second Measurement M3 This is a two point measurement CALCULATION OF RESULT M3 M2 X FACTOR FIXED TIME TEST 2 reagents Read Reagent cuvette M1 Add Reagent 2 Add Reagent blank RB Add Sample 9 40 seconds 62 88 114 140 166 192 218 244 270 296 322 eagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate gt gt Ss Inc Time 1 Inc Time 2 Read Time 4 6 8 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 variable Example 62 sec or any other time from the table 5 Add reagent 2 and mix 6 Incubation Time 2 variable Example 62 sec or any other time from the table 7 Measure Sample M2 First Measurement 8 Read Time 78 sec or any other time Second Measurement M3 This is a two point measurement CALCULATION OF RESULT M3 M2 X FACTOR In case of RB BIAS the calculation becomes CALCULATION OF RESULT M3 M2 BIAS x FACTOR 100 Human HumaStar 300 User Manual KINETIC TEST Singl
8. 1 Use of Profiles during Patient Entry 2 On Line Print Results 3 Automatic Repetition of Results 4 STD calibration in triplicate 5 Select primary tube 6 Show factor in standard section 94 Human HumaStar 300 User Manual Options not included in the Standard Analyzer are 1 Bar Code reader for Reagents 2 Bar Code for positive Sample Identification These options requires special software and modules to be implemented and available only upon request For Detailed Information see Chapter 3 7 Human I o Diagnostics Worldwide 95 F8 MAINTENANCE da Click F8 to open BOOK to MAINTENANCE The Maintenance is divided into 3 parts the Reagent System the Sample System and the Measurement System There is a complete auto check every time the analyzer is turned ON This maintenance program has been developed to enable to check and control every operation in the system This makes possible to quickly identify any problem or failure on the system ON LINE and eventually make repairs immediately or via a phone or modem line A description and explanation of the Maintenance program is given in the Service Manual Herewith there is only a list of checks and controls that the analyzer system goes through every time the analyzer is turned ON as well as all the controls that are performed during operation It is possible to check every moving part in the system as well as do maintenance that the analyzer requires fr
9. 10 0 47 1 47 0 43 Human PR o Diagnostics Worldwide 65 5 4 Data Exchange with Host Computer The SOFTWARE of the HumaStar 300 produced by HUMAN enables the exchange of data with other computers via a serial port RS232 connection There are two options available 1 Transfer of Worklist download from Host 2 Transfer of Results Upload to Host 5 4 1 Host Computer Setup The Host Computer to be connected to the HumaStar 300 should have the following set up 19200 n 8 1 XON XOFF 5 4 2 Connection from Host Computer To HumaStar 300 The Host Computer should be connected to the first serial COM 1 by means of a serial cable whose connections are described below HOST COMPUTER DTE HumaStar DTE DB9 DB25 DB9 2 E Ar ei 3 3 De E O 2 5 aee 5 5 4 3 Protocol The exchange of data is organised in packs These packs can be generally classified as A prologue pack sent at the beginning of the file to signal the number of data lines that are going to be transmitted Following is a description of a prologue pack HeadChar NumberOfLines CheckSum CR Data pack sent after a prologue pack following is its description HeadChar DataRecord CheckSum CR there is a space with a character ASCII 32 hex 20 HeadChar is a single character line header R Result for uploading P Patient in case of downloading NumberOfLines is the number of lines Data packs that are
10. 12D9 35 U L 0 35 200501201512 1672 Cardio 0 GLUC 2 108 mg dl 65 105 200501201512 1814 2 1 968 mg dl 8 1 4 200501201512 18BD Cardio 0 BilBic 2 1 59 mg dl 0 1 2 200501201512 1902 0 BilBic 2 1 58 mg dl 0 1 2 200501201512 1C1A OJAST 0 34 U L 0 35 200501201512 198A O GLUC O 103 mg dl 65 105 200501201512 1B26 O CREAT 2 1 937 mg dl 7 1 2 200501201512 1BCF R 12345678 Verdi Mario 18 0 O CREAT 1 453 mg dl 7 1 2 200501201512 159F R 12345678 Verdi Mario 18 0 O BilBic O 34 mg dl 0 1 2 200501201512 15EA R 12345678 Verdi Mario 18 0 O AST O 7JU L 0 35 200501201512 1363 R 12345678 Verdi Mario 18 0 0 GLUC 1 29 mg dl 65 105 200501201512 1507 NOTE To activate LIS communication select F9 print ON LINE Human PA o Diagnostics Worldwide 69 70 Human HumasStar 300 User Manual 6 Maintenance Program In this section are described all the controls and checks that the system does when turned ON and its maintenance The maintenance is divided in three parts 1 Reagent System 2 Sample System 3 Measurement System This program enables the operator to run a complete diagnostic check of the system without the need of a service engineer When turned ON the analyzer goes through a complete functional Auto check and when everything is in order the green triangle START is lighted indicating that the analyzer is ready for operation During the Auto check should there be an
11. Any damage so incurred shall be reported to the freight carrier for settlement or claim Human I A Diagnostics Worldwide 3 1 3 Installation 1 3 1 Unpacking Shipping and packing materials have been selected to provide maximum protection during transportation under normal handling conditions NOTICE once the carrier has taken possession of the system for transportation from the factory the carrier assumes all liability until delivery All claims for damage due to transportation must be filed with the carrier as soon as possible 1 3 1 1 Examine the shipping crate and cartons for indications of damage e g crushed or indented walls holes or gouges water damage etc Have the carrier note any such damage on the delivery receipt this will simplify formulating a claim ifany ofthe instruments or parts are damaged NOTICE the system serial number is identified as the serial number of the Analyzer Open the carton from the top and remove the instrument with care as shown on the graph above It is recommended that two people help with the removal of the instrument from its crate and its plastic bag Save the crate and packing material until you are sure you have received everything and all is in good working condition 1 3 2 Installation The Analyzer system must be installed in the laboratory by specialised personnel At the time of installation the system will be checked to ensure proper operati
12. Calibration in triplicate to run a standard in triplicate from the same sample cup during Calibration Will report a Mean value as the result 4 Automatic Repetition of Results enables to repeat automatically a test if its result is out of Linear Range LIN or Substrate Depletion SDP 5 Samples and Reagents with Bar Code enables the identification of samples and reagents if the Bar Code Reader is installed 6 Use of Primary Tubes has to be activated when working with primary tubes 7 Display Factor in the Standard Program activate to display the calculated Factor during Calibration instead of Optical Density ofthe Standard 44 Human HumasStar 300 User Manual 3 7 2 Special Options upon request 1 Bar Code Reader for Samples and Reagents installation has to be made in factory or by qualified personnel 2 Identification of Samples with Optical Pen to identify the Bar Code of Samples An Optical Pen can be used in parallel with the keyboard File Edt Graph Navigation 2 3 10 06 11 43 22 AM Y Automatic repetition of results Select primary tube iw Show factor in standard section Ready A HE P M4242aMauoCheck 0K 7 3 7 2 1 Diagnostics Worldwide 45 46 Human HumaStar 300 User Manual 4 Analyzer Operation 4 1 Analyzer Operation Check before Start Before turning ON the analyzer make sure a Tofillthe Wash Solution Container with fresh solution and place the liquid sensor fo
13. Check 48 Human HumaStar 300 User Manual If Bar Code Reader is built in it will check the reagent positions if they are as programmed on the Reagent On Line page If the Reagent is not recognized there will be a Warning A After the Reagents have been recognized the Sampling Probe will enter into each of the programmed reagent bottles and check its volume The quantity of reagent will be displayed in Test as number of tests available in the reagent bottle When the analyzer is not ready or the operational check failed the small red warning triangle will be ON Click on the arrow next to it to identify the reason Check Maintenance and trouble shooting guide to solve the problem before proceeding A In case of Warning or Error make sure that a Test using 2 reagents has been assigned 2 positions onthe Rack and both Reagents are present Make sure to have enough Reagent for the daily use To add Reagent click on its Check Box to deactivate it add reagent and then click again to activate Click START to repeat the Reagent volume check only on that reagent To proceed operation click START gt Start Operations es 2 x Searching operations No maintenance requesl Rack A 1 10 Pal no warnings present No reagent request no incongruences present No calibration request standards present Predil Ratio Start Operation for above Rack No Change Predilution cups betore to start Pre
14. Empty Alphanumeric Sample Type 1 digit 0 Serum Plasma 1 Urine 2 FCS List of Tests 3 Variable Length Alphanumeric 4 1 Can be empty only ifthe Family Name is not empty 2 Can be empty only if PID is not empty 3 The DataRecord must contain a list of tests for the patient 4 Each test has to be incorporated between the strings ASCII 176 and ASCII 167 and must be max 6 characters Example P 60126 P 123 Jimmy Denver 77 1 Private Patient 0 AST BilBic CREAT GLUC 1AF2 P 1234 Frank Rossi 18 1 Epat O AST BilBic CREAT GLUC 16A1 P 12345 Elisa Ribas 34 0 0 AST BilBic CREAT GLUCS 14F8 P 123456 Walter Giotto 88 1 Cardio 0 AST BilBic CREAT GLUC 1890 P 1234567 Coppi Sandra 33 0 Private Patient 0 AST BilBic CREAT GLUC 1BA9 P 12345678 Verdi Mario 18 0 O AST BilBic CREAT GLUC 15B2 Where P 123 Jimmy Denver 77 1 Private Patient O AST BilBic CREAT GLUC 1AF2 P space are prologue to DataRecord space cod ascii32 hex20 123 identification of sample max 13 characters Jimmy Fam Name max 16 characters Denver First name max 12 characters 77 Age 1 Sex 0 Female 1 Male Empty Accept Time Private Patient Comments max 22 characters 0 Type of Sample see table start test name cod ascii176 AST test name max 6 characters end test name cod ascii167 next test always
15. Incubation 322 seconds first turn plate IncTime 1 Inc Time 2 4 6 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 variable Example 62 sec or anyother time from the table 5 Measure Sample M2 before adding Reagent REAGENT 2 after 62 sec 6 Incubation Time 2 Example 260 sec 7 Measure final reaction M3 CALCULATION OF RESULT M3 M2 X FACTOR Note Sample Blank is measured just before adding Reagent 2 Incubation 1 and Incubation 2 are variable 102 Human HumaStar 300 User Manual BICHROMATIC DETERMINATION 2 3 Read Reagent cuvette M1 Read End Point M2 Add Reagent blank RB Add Sample 9 40 seconds eagent preheating to 37 C About 9C Max Incubation 322 seconds first turn plate Add reagent into cuvette Within 9 to 40 seconds Read Reagent cuvette Blank M1 at 2 different wavelengths ADD SAMPLE to preheated reagent and mix Incubation Time 1 variable See Incubation Table Read final reaction of sample M2 at 2 different wavelengths Incubation of reactiion can be anywhere from 36 to 322 seconds at intervals of 26 seconds Set incubation as necessary for the method from the incubation Table 1 CALCULATION filter M2 Afilter M1 x FACTOR Where A filter is the difference in mAbs between the 2 wavelengths NOTE Bichromatic determination can be single or two reagents FIXED
16. Intelligent STOP Display Bar that identifies the error or warning For Detailed Information see Chapter 4 3 96 Human HumaStar 300 User Manual FLAGS WARNINGS and ERRORS Q The following Flags and Error Warnings will be displayed during analyzer operation 1 1 RSE UM qa ty N 10 12 13 Rept test to be repeated Low result below normal range High result above normal range OD Optical Density out of range lt RB gt Reagent blank out of range SbDp Substrate Depletion lt NL gt Non linear Kinetic measurement Std No standard available Log error in Log Logit determination lt 0 negative result Lin Result above Linearity Limit Rgt Missing Reagent Smp Missing Sample Error in ISE module ISEC ISE Cal A Air ISEa ISE Air Error ISEn ISE Noise Error ISEd ISE Drift Error ISEo ISE Out Range For detail see Chapter 7 Human I o Diagnostics Worldwide 97 98 Human HumaStar 300 User Manual 8 Appendix Reaction details END POINT Single Reagent 1 2 3 4 5 z 5 5 EE 2 o OU q v O E Yor d s 385 S 30m 2 e St E S 9 40 seconds 10 36 62 88 114 140 166 192 218 244 270 296 322 Ara Reagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate 1 Add reagent into cu
17. Patient Report Normally the print done during operation is per patient OPTIONS is activated On Line Patient s results are printed one after the other there might be several patients on the same page This print is ideal for routine testing in case one wants to check x Cancel O List by Test a O List by Sample OK O Print by Report From Position 1 To Position 10 4 7 1 The results before printing the Final Report However the final Patient Report can be printed any time as follows 1 From the Main Menu click on File and the Print There are 3 possibilities of print a Print by Test b Print by Patient c Print Final Patient Report Choose accordingly 56 Human HumaStar 300 User Manual 4 8 Special Notes 4 8 1 Flags and or Errors displayed On Line Rept sample to be repeated Low result below normal range High result above normal range OD Optical Density out of range lt RB gt Reagent blank out of range SbDp Substrate Depletion lt NL gt Non linear Kinetic measurement Std No standard available Log error in Log Logit determination lt 0 negative result Lin Result above Linearity Limit Rgt Missing Reagent Smp Missing Sample Error in ISE module ISEc ISE Cal A Air ISEa ISE Air Error ISEn ISE Noise Error ISEd ISE Drift Error
18. Reagents f Stabil hrs stability time of reagent once placed on the analyzer There will be a flag when the time is up To deactivate stability time enter 999 g Lot Numbers enter the lot number indicated on the reagent bottle h Bottle Type there are two sizes N 1 50 ml N 2 5ml i LD Reagents insert identification number only if the Bar Code Reader is installed It checks the bottle position inside the Reagent Tray 9 FILTERS nm a First amp Second Click on the line to open the window that displays the 8 built in interference filters Choose according to the method b Second Filter Used only in Bichromatic Methods d Bichromatic Factor not active parameter Human PA o Diagnostics Worldwide 33 Page 3 includes 2 21 05 5 12 53 PM AST GOT Read Time sec 168 CHECK ABSORBANCE mAbs P Blank mir 1000 max 2200 Substr Depl min 300 CALCULATION Calibrate Factor Factor 1822 000 Reag Bias No LINEAR CORRELATION Intercept 0 00 Slope 1 00 gt 15 11 21 PM Auto Check OK 3 3 4 10 REACTION a Type click to open the options and choose one a EndPoint b Fixed Time c Kinetic b Read Time sec Measurement Time Click to open window and choose from the pre programmed and optimized times Only for Kinetic and Fixed Time Methods a For End Point measurements the time is fixed b For Fixed time and Kinetic measurement times can vary f
19. Registers Contains the following sub programs File Registers Tools 2 Operation F Data from Archive Methodology Profiles Standards Controls QC Maintenance Options 2 4 1 The following functions can be programmed from Registers or simply a click on its ICON or on its functional key from F2 to F9 NOTE The program METHODS FA is protected by a password 2 5 Tools Contains the following sub programs File Register Tools 2 v Esser Mode Instrument nit Preprer FR Rees culate Results Repot Definition iid E a nte a Y 2 5 1 1 Expert Mode Enables to introduce the password to access METHODS F4 2 Init instrument To repeat an initial Auto Check of the Analyzer 20 Human HumaStar 300 User Manual 3 Prepper This function enables to automatically pre dilute the sample OFF LINE Follow instructions indicated on the monitor 2x op Insert initial and final positions to use prepper sp select prediution ratio and then press OK _ Cancel From position 1 40 ft To position 1 40 ft Gun pe E Samples Ring Internat zl 4 Load Sample Rack Identification of samples with the built in BAR CODE READER optional Ele Edt Graph Navigation 2 3 8 06 3 55 30 PM J Available Reagents I Reagents On Line Cite Set Reagent Test Stbihrs Bott Cool Test lm Y TAG 999 1 Dua SE Human D Diagnostics Worldwide 21 5 Recalculate Results Enables to recal
20. again after 52 sec to check for substrate depletion M2 Incubation 2 example 78 sec or any other time Read time for Kinetic measurement example 130 sec or any other time M3 CALCULATION is a Linear Regression based on the 130 sec measurement multiplied by its FACTOR END POINT 2 reagents POST R2 3 5 Add Reagent 1 Add Sample Dispense Reagent 2 Read Sample cuvette Blank Read End Point 9 40 seconds Reagent preheating to 37 C Abq Max Incubation 322 seconds first turn plate gt ey Inc 1 62 Incubation 2 260 4 1 Add reagent into cuvette 2 ADD SAMPLE to preheated reagent and mix 3 Add REAGENT 2 example after 62 sec 4 Incubation Time 1 variable See Incubation Table Example 62 sec 5 Within 9 to 40 seconds Read Reagent cuvette Blank M1 6 Measure final reaction M2 CALCULATION OF RESULT M2 M1 X FACTOR 104 Human HumaStar 300 User Manual HUMAN Gesellschaft fur Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 61 22 99 88 0 Fax 49 61 22 99 88 100 e Mail human human de www human de Human EEE
21. as the ISE module are optional and are available directly from the factory They can also be installed at a later date at the customer s side by an authorised service engineer 5 1 Bar Code Reader for Samples and Reagent 5 1 1 The Bar Code can read the following codes UPC EAN Code 128 1 Code 39 w N Interleaved 2 of 5 Codabar gt 5 Per additional information contact your local agent 5 1 2 To identify the samples with the Bar Code File Registers Tools 2 v Expert Mode Instrument Init Prepper S FS Recalculate Results Report Definition Z F4 Date and Time A F5 FS AM 5 1 2 1 Select Bar Code Reader From the Main Menu go to OPTIONS F9 Select Samples with Bar Code See Fig 5 1 2 1 Insert Sample Tray The Bar Code will identify automatically the samples See Fig 5 1 2 2 A window will open displaying the Sample Tray and commands to identify them e Ad S Human I A Diagnostics Worldwide 59 File Registers Optore 2 09 30 2001 15228 Sample Rack Load 00000 O Q O S O FeeePostions DD Sorel weruhee Sara NOT Vermeil O AmepedPostions A go O 5 1 2 2 Sample Tray Bar Code Identification 5 Ifthe samples have been transferred via Serial port RS 232 these should contain as follows a ID number of the sample b Test to be performed 6 Make sure that the identification label with its Code on the Primary tube is visible on the Sample Tray 7
22. diluter Check reading cuvettes Check washing probe Clean probe s washing chamber General cleaning and tubing check Replace sensor level s flat cable General revision HELP ON LINE TELL ME HOW Welcome to the HELP ON LINE Click for the following information 1 Reagents On Line 2 Calibration 3 Patient Entry 4 STAT Operation 86 Human HumaStar 300 User Manual HumaStar 300 Maintenance Program 15days 30days 4months 6months EN Y O E O lyear 2year 5 Archive 6 Print Results 7 Methodologies 8 To Program a New Method 9 Standards and Calibrators 10 Profile 11 Controls 12 Ouality Control Program 13 Options 14 Maintenance 15 Special Functions 16 Warnings and Errors Ov ZF QQraRre REAGENTS ON LINE 2 SE Click the mouse on Operations F2 Reagents On Line All the chemistries that have been performed during the last run are displayed on the right There are a total of 30 ON LINE reagents that are identified from 1 to 30 on that page To see reagents 20 through 30 scroll the bar on the right To choose the methods to run today simply click the mouse on its check box If a new reagent or method is needed and is not on that list click the mouse on free position which is identified by an asterisk to highlight it and to open the left side page where all the remaining programmed chemistry methods are displayed C
23. for each individual method 8 Various possibilities of performing particular tests 9 Many checks and controls to assure reliability and accuracy of operation Human mme Diagnostics Worldwide 27 28 Human HumaStar 300 User Manual 3 Software 3 1 Software HumaStar 300 has an extremely easy and user friendly software with graphic presentation all incorporated into a Book which further simplifies its use A HELP On Line guides the operator during programming and operation Most of the special functions have been described in Chapter 2 herewith are described in detail the various parts of the program Methods F4 are protected by a password that can be defined by the user at the time of analyzer installation File Registers Tools 3 3 06 9 44 10 AM E FA HumaStar 300 F3 F4 F5 FE F7 F Fg e Qtr SS E Ready Human Diagnostics Worldwide 29 3 2 F3 Archive y Click on its ICON to open the options offered ww Archive Selection CG Internal Archive Cancel Archive on Diskette OK O Test Statistic O Test Counter O Last Warnings 3 2 1 3 3 F4 Methods S Click on its ICON or F4 to open the window with the 2 choices Regular Methods O Calculated Methods DK 3 3 1 1 Regular Methods access to all the Chemistry methods in alphabetical order 2 Calculated Methods user programmable formula to calculate RATI
24. introduced This operation is done automatically through the Maintenance program Simply press first Drain Bath and then Fill Bath NOTE USE ONLY BI DISTILLED WATER FOR THE INCUBATION BATH 3 4 16 MONITORA 11 ON OFF SWITCH 15 VOLTAGE SELECTOR AIR PUMP 1 4 1 1 ISE CALIBRATOR A Place the Calibrator A bottle close to the ISE module and close it with its level sensor cap When using the ISE module the reagent will automatically fill the system For details see ISE Calibration WASTE It is suggested to empty the Waste Container daily and rinse it with a detergent to avoid bacteria formation 6 Human HumaStar 300 User Manual 15 Description of the Analyzer 1 5 1 Layout The analyzer consists in three main parts which are assembled on a single support REAGENTS SAMPLES REACTION MEASUREMENT including cuvette washing system See Figure 1 4 3 1 each of these parts will be described in detail below REACTION PLATE with 39 cuvettes and Built Photometer Reagent Dispensing Arm Sample Dispensing Arm 4 STAT 16 Place for Standard and Controls NY J Washing well LS E Primary tube 30 ON LINE REAGENT SAMPLE TRAY 1 5 1 1 Layout Human PN Diagnostics Worldwide 7 1 5 2 Analytical Plate and its incubation thermostatic bath The reaction takes place in an analytical place containing 39 quartz cuvettes The plate is inc
25. the requested operation an OK will be displayed with the time of operation Wait for the Green Triangle START to be On before requesting the next operation 6 4 Daily Checks During SHUT DOWN of the analyzer there will be an automatic wash of the cuvettes In case of a non correct Shut Down of the Analyzer when analyzer is turned ON again after having done the necessary Auto checks it will wash the cuvettes Daily maintenance a Empty Waste container b Fill the Wash Container with fresh solution Make sure to use good quality distilled water bad quality of water may give ERRORS with the level sensor c Fillthe container with bi distilled water for the incubation bath d If ISE Module is installed check the presence of CAL A reagent e Remove all reagents Note WHEN ANALYZER IS TURNED OFF THE COOLING OF REAGENT TRAY IS ALSO OFF Human A Diagnostics Worldwide 73 6 5 Maintenance every TWO weeks Change the bi distilled water in the Thermostat and Incubation Bath 1 Empty and then refill with fresh bi distilled water use the Maintenance program 2 Depending on the tests performed however it is suggested to wash the cuvettes with a diluted Solution of Extran or a similar product used for laboratory glassware Use the Clean procedure found in the Maintenance program 6 6 Operation to be done every 2 months Clean Thermostat and Incubation Bath 1 This should be done using a liquid detergent for
26. to loose the O ring 3 Unscrew the syringe body 2 including its piston Make sure to fit the O ring 3 properly when mounting the new syringe gt 5 Note Do this operation only if necessary if there is a leaking or broken syringe 6 7 6 1 Diluter Syringe 1 Piston 6 Syringe holder 2 Syringe body 7 Tip tubing locking screw 3 O ring 8 Tubingto Wash solution 4 Piston locking screw 9 Tubingto Probe 5 Locking screw syringe Human I o Diagnostics Worldwide 79 80 Human HumaStar 300 User Manual 7 Trouble Shooting Spare Parts 7 1 Trouble Shooting Guide SYMPTOM Analyzer does not Turn On Photometer lamp is OFF Program does not load Printer does not turn ON Printer does not print On Line Printer does not print Patient Reports or other print outs Tubing leading to the two Probes are empty Air bubbles in the tubing leading to the Probe Photometer does not read Diluter Module stops Diluter does not aspirate or dispense Syringe has difficulty in filling or emptying Water Blank has too high an Absorbance Results are not reproducible CAUSES AND REMEDIES check power supply cord if inserted check fuse check voltage input Make sure that the Monitor is ON check power supply before changing lamp if computer and instrument is ON change lamp Turn OFF the analyzer Wait 10 sec and Turn ON again Make sure that the power cord is plugged in Make sure it is connected to the analy
27. two pages click the triangle on the bottom of the page 7 SAMPLE File Edit Graph Navigation 2 AST GL SAMPLE REAC Volume ul 30 Type Predil ratio Read REAGENTS First Second CHECI Features none R Bla Volumes ul 300 3 Incub sec 72 0 Subst Cooling Yes No Stabil hrs 999 999 CALCL Lot Numbers Calibr Bottle Type Facto Reag ID First ID Second FILTERS nm LINEA First amp Second 340 Interc Bichromatic Factor Slope Ready A BP nza a Volume from 3 to 70 ul b Predil Ratio Option enables the automatic pre dilution of Samples Standards and Controls before starting a run To select the dilution ratio click on the line to open the 15 pre programmed dilution ratios 2 4 5 10 20 30 40 50 60 70 80 90 100 150 and 200 8 REAGENTS Features Click on the line to display the available options none Single Reagent Standard Method Mono Diff Single Reagent Fixed Differential Method the first measurement M1 is taken 6 sec after the addition of the sample Sample Blank The final measurement M2 is taken after the programmed incubation time Bi Reag Two Reagents Standard Method Diff Fix Two Reagents Fixed Differential Method the first measurement M1 is taken 6 sec after the addition of sample to the first reagent R1 sample Blank The second reagent R2 is added after the programmed Incubation 1 final measurement M2 is taken after th
28. Control 43 3 6 2 To Delete or Chan Bera ControlV alle unse 43 316 3 Oualityi Control Programas cases POB PEO O sc a an 44 ET el EE 44 3 7 1 Standard Options can be activated by the operator when needed mer 44 34 2 Special Options UN II 45 4 Analyzer Operationen allen essen are REISENDEN teen 47 dd SEET EE 47 EA LE A A EES 47 4 2 1 Check Reagent Volumes for the Daily Run 48 4 2 2 Prepper the Auto Pre dilution system EEN 50 KERSCHT CL 50 4 3 1 The Calibration page arar 51 4 3 2 To program a Serum Control for Calibration ENEE 51 43 3 Multi Standard Eallbration COPA OR In PA or ada 51 Ee UE TEE EN E ET EN E Een 51 4 3 7 Check Calibration 51 4 3 8 To Repeat a Standard or Calibrator 4 3 9 To Repeat a Serum Control BER 4 3 10 To Display the graph of a Calibration or a Kinetic Control 44 Patient Emtnm EEN BEE 4 4 1 To Program Patients using Profiles BEE Ee EE EEN 54 A A NO 55 4 6 1 To Add Samples During Operation EEN 55 4 6 2 To Repeat a Test a Sample or All Tests ENEE 55 4 6 3 To Recalculate a Test against a New Factor ue 56 4 7 MAP TIME Of a RR ao 56 48 Special NOTES S Saa Saaai RRRS Ea SRE E ERES ES EES a SESS 57 481 Hags apndiorkrrorts gdleplavegd On Dip smsen 57 4 8 2 Sample Pre dilutionz WI N een nes 57 5 Bar Code Reader se Module Data EXchange n u ensneeesee nennen 59 5 1 Bar Code Reader for Samples and Reagent EEN 59 5 1 1 The Bar Code can read the follow
29. GGT GLUC IRON LDH MAGN TB T P UA 3 6 1 To Program a New Control 2 21 05 5 27 07 PM 3322 05 27 10 StdDev Q C page H 06 19 03 21 12 23 5 25 07 27 3498 23 10 31 04 35 03 37 3 39 10 41 10 43 30 45 06 47 06 51 53 57 59 Click Edit and the Insert Page Introduce the name of the new Control and click OK Introduce the Expiration date and its Lot Number a Click on the line with an asterisk on the right On the left are displayed all the available methods Click on the check box of the desired method to highlight b Click the mouse on Mean and enter the Mean Value for that method including the value of the plus and minus corresponding to 2 Standard Deviations or the values indicated on the sheet supplied with the Control Program one by one all the methods that are part of that Control Example GLUCOSE the theoretical value is 100 mg dl with 6 3 6 2 To Delete or Change a Control Value Simply highlight the Control and press Canc on the keyboard A confirmation window will open choose accordingly To Delete the Page or the whole Control click Edit and choose Delete Page A confirmation window will open choose accordingly To Change the Value of a single method simply click on its value and change accordingly To exit press the book cover to close the book or Navigation to close the book The programmed controls are automatically saved Human A Diagnosti
30. HumaStar 300 User Manual ee ET UTA AG ELIT atol Meares CEA FE AR Sa IRA de ERARA agt CE Human EEE No Rev Date 01 2008 07 02 2010 08 REVISION LIST OF THE MANUAL REVISION DESCRIPTION First edition for modified HumaStar 300 from S N A520331 Correction of typing errors Human PA A Diagnostics Worldwide 1 INTRODUCTION This manual is considered as a part of the instrument it has to be at the operator s hand as well as at the maintenance operator s availability For accurate installation use and maintenance please read the following instructions carefully In order to avoid instrument or personal damages carefully read the GENERAL SAFETY WARNINGS describing the suitable operating procedures In case of breakdowns or any troubles with the instrument apply to the local Technical Service 2 USER WARRANTY HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in material or workmanship provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser The HUMAN representative shall replace or repair any defective item at no charge except for transportation expenses to the point of repair This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage e g lamps valv
31. No maintenance request Rack A 1 10 Pal no warnings present No reagent request no incongruences present No calibration request standards present Predil Ratio Start Operation for above Rack N Change Predilution cups before to start Press OK to confirm and start operation Cancel 4 6 1 The analyzer can be started to run the routine Patient samples or STATs any time after the analyzer has been calibrated for the day Place at least one Sample Tray with the programmed samples and Press START the GREEN TRIANGLE below A confirmation window will be opened press OK 4 6 1 To Add Samples During Operation The analyzer is protected with a cover during operation not to disturb the moving parts To add new samples or STATS onto the Sample Tray the analyzer has to be STOPPED Click on the RED square next to the START The Sampling will STOP while the rest of the analyzer will continue operation Wait until the message displays Sampling stopped only then open the cover and introduce the desired samples Sample Tray or even Reagents if necessary Press START to continue operation Make sure that the Plexiglas cove is closed again Note DO NOT INTRODUCE SAMPLES OR REAGENTS WHILE THE ANALYZER IS IN OPERATION IT MAY DAMAGE THE SAMPLING ARM KEEP THE PLEXIGLAS COVER CLOSED DURING OPERATION 4 6 2 To Repeat a Test a Sample or All Tests To repeat a Sample or a Test proceed as follow 1 Select the d
32. OS and calculated methods on tests performed See Par 4 2 2 30 Human HumaStar 300 User Manual To Program a Method The parameters of a method are described on three pages Page one contains the following information to be programmed 2721705 5 12 28 PM TestName AST GOT Meas Unit UAL Decimals 0 REFERENCE Bay 0 35 Girl 0 35 er Age Limit 15 Male 0 35 Female 0 35 Age over 60 Male 0 35 Female 0 LINEARITY LIMIT QUALITY CONTROL Repeat control every hrs 1 EIA PM Auto Check DK 3 3 2 1 Name of Test Introduce a name for the Test 2 Units units of measurement mg dl U I g l etc 3 Decimals decimals in final result max 3 4 Reference Values enter Min and Max of Normal of reference values according to age and sex 5 Linearity Limit maximum linearity value for the method according to the reagent manufacturer If the value is not defined all results will be flagged as LIN non linear NOTE When the Automatic Repetition of Results is active all results that are above the programmed Linearity Limit will be automatically repeated using half the sample volume indicated in the method and the result corrected 6 Quality Control Repeat Control every hour enter the hours to automatically repeat the Serum Control for the Quality Control Program To exclude enter 99 Human ze Diagnostics Worldwide 31 To open the next
33. TIME TEST 2 reagents POST R2 E D be D Ka E o Ed el Dispense Sample Dispense Reagent 2 9 40 seconds Pre heating Incubation Time 1 Read Time 1 Dispense reagent 1 into cuvette anywhere from 50 to 300 ul No reagent blank reading 2 Dispense sample Incubation time 1 variable from 36 seconds on 3 Dispense reagent 2 into cuvette Total volume R2 sample R1 must be at least 300 ul 4 First reading will be taken 13 after 5 Second reading after the Read time Introduce READ TIME for all Kinetic and Fixed Time Introduce INCUBATION TIME 2 for End Point This is a two point measurement CALCULATION OF RESULT M2 M1 X FACTOR In case of RB BIAS the calculation becomes CALCULATION OF RESULT M2 M1 BIAS x FACTOR Human A Diagnostics Worldwide 103 KINETIC TEST 2 reagents POST R2 4 5 M2 Read Reagent cuvette blank Mi Measure solution within 10 6 N Dispense Reagent 1 DispenseSample Check substrate depletion Dispense Reagent 2 w 3 9 40 seconds 36 62 ss 114 140 166 192 218 de A 296 322 Reagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate pe S Inc 1 62 Inc 2 78 Read Time 130 Dispense reagent 1 into cuvette ADD SAMPLE to preheated reagent and mix Incubation Time 1 of sample example 62 sec or any time Add Reagent 2 Starter Within 9 to 40 seconds Read Sample cuvette Blank M1 Measure solution
34. aStar 300 User Manual Cat Number 17903 5 17903 6 17903 7 17903 8 17903 9 17903 4 17903 2 17903 1 17903 3 17903 10 17903 11 Description Calibrant A 500 ml Calibrant B 125 ml Cleaner 125 ml Diluent for Urine 125 ml Pump Cassette Reference Electrode Electrode for K Electrode for Na Electrode for Cl Compression seals box of 5 O ring box of 4 Table 5 3 6 1 Results obtained with the ISE Module Mean SD CV Mean SD CV First Instrument Na 134 132 132 132 132 132 131 131 131 132 131 90 0 88 0 66 Third Instrument Na 150 151 151 150 151 151 153 152 150 151 151 00 0 9428 0 6244 K 4 10 4 00 4 00 4 00 4 10 4 10 4 10 4 10 4 10 4 00 4 06 0 05 1 27 K 6 90 6 90 7 00 7 00 7 00 7 00 7 00 7 10 7 10 7 00 7 00 0 07 0 95 Cl 98 97 97 97 97 97 97 97 97 96 97 00 0 47 0 49 Cl 111 110 110 110 110 110 110 111 110 110 110 20 0 42 0 38 Mean SD CV Mean SD CV Second Instrument Na 135 131 131 131 131 131 132 132 131 75 1 39 1 05 Fourth Instrument Na 150 150 149 149 153 151 151 150 150 151 150 40 1 17 0 78 Qty 4 2 2 2 2 1 1 1 1 1 1 K Cl 3 80 98 3 80 97 3 80 98 3 80 98 3 80 97 3 80 97 3 80 97 3 80 98 3 80 97 50 0 00 0 53 0 00 0 55 K Cl 6 90 110 6 90 110 6 90 110 6 90 111 7 10 109 7 10 110 7 10 110 7 10 110 7 10 110 7 10 110 7 02 110 00 0
35. ace the Syringe 79 7 Trouble Shooting Spare Parts 81 7 1 Trouble Shooting Guide 81 7 2 Spare parts and accessories 84 7 3 Suggestions and Warnings 85 7 4 HUMaStar 300 Maintenance Prograrny srvasercsvssescsrasssoossasesoanssssoassssesostansoonnssscounsassoonnssssounsassossniusesousasescesusseseusasescoguasesgend 86 8 Apperidix Redetion UE 99 Human Diagnostics Worldwide iv iv Human HumaStar 300 User Manual 1 General Description HumaStar 300 is an automatic random access Chemistry Analyzer to run your daily workload a single test a profile an organ panel or STAT with the same speed and efficiency HumasStar 300 incorporates the latest in the art of smart technology and a sophisticated software that simplifies the work of the operator and offers maximum versatility and reliability of operation The analyzer offers many new and desirable features including a throughput of 300 chemistry test single reagent plus over 180 electrolytes per hour 5 at the same time making it ideal in any size laboratory Fig 1 1 Human wm Bi Wer Diagnostics Worldwide al 1 1 Main Characteristics Humastar 300 is fully controlled by a built in Pentium computer and performs the tests in a true random access mode where all tests for sample ONE are processed before starting on sample number TWO Each sample is treated like a STAT and a Patient Report is automatically printed THROUGHPUT 300 Chemistry te
36. agent Identification Number if Bar Code Reader is built in 11 Select Primary Filter 1 Select Filter 2 only if Bichromatic 12 Type End Point 13 Measurement Time it is programmed by default 14 Enter the values in mAbs for the Reagent Blank both Min and Max A check will be made during operation Example Glucose Min 0 Max 150 mAbs 15 Substrate Depl min Parameter active only for Kinetic 16 Calculation select between Standard Factor o Multistandard 17 If against Factor enter the factor value 18 If against Standard introduce its value in the Standard program F6 See graphic Presentation of the Method in Addendum 1b End Point Two Reagent Test Program as above points 1and 2 3 Features Bi Reagent 4 Program the volume of the second Reagent R2 from 3 ul to 500 pl 5a Program incubation time 1 time before the addition of R2 5b Program incubation time 2 time before final measurement All other parameters remain the same See graphic Presentation of the Method in Addendum Human PA Diagnostics Worldwide 35 2 Bichromatic Determination 1 Bichromatic Determinations can be End Point Fixed time or Kinetic 2 In point 10 above enter both Filter 1 and Filter 2 All other parameters remain the same See graphic Presentation of the Method in Addendum 36 Human HumaStar 300 User Manual 3 Fixed Time Determinations This is a two point measurement using a single or two Reag
37. anomaly an errors or warning these will be notified by the red Triangle The Warning massages will be displayed by clicking on its arrow Some of the messages are common such as missing Wash Solution Incubation Temperature not yet at 37 C etc Other Warnings or flags such as INIT hardware Filter identification etc require to consult the Maintenance program and check accordingly 6 1 Reagent System From the Main Menu click on F8 MAINTENANCE as shown on the figure below the main Auto checks of the Reagent and Sample System are all OK EN Fie Edt Graph Navigation 2 Reagent System Set Actor Tee Instrument On Line 11 18 Ind Hardware 11 19 FA Hydiaados 11 19 Wash Probe 11 19 Ind Code Reader Test Digo Test Liquid Sensor Pump P4 ON Pump P4 OFF Text Purp P2 Home Z Avis Home Plate Home Asm Homa Diner Arm On Reagerk Asm On Cuvette Arm on Wath M mee On 5 sec 6 1 1 Reagent System Human SP Diagnostics Worldwide Zi 6 2 Sample System 3710 06 11 49 46 AM Sample System Set Acton Tme Instrument On Line 11 19 Ind Hardware 11 19 Fil Hydraubes 1 20 Wash Probe 1120 Int Coda Reader Test D ser Test Sample Laval Test Pump Pi Test Predl Level Test Clean Level Test Cal B Level ISE modi On Lime ISE Maintenance ISE Purge ISE Clean Home Z Aust Home Piste Home Asm Home Dater Ready A E gt imasaamasChexor z 6 2 1 Sample System How to use the above program
38. ar 300 User Manual 2 Start Up 2 1 Start Up Turn ON the Analyzer The analyzer goes through an Auto check program and any anomaly will be automatically flagged When ready the green triangle START will be lit 2 2 Main Menu Display The Main Display is divided into 4 parts Part 1 contains all the commands for operation Part 2 contains all the icons of the 8 sub programs or Registers Part 3 indicates the Status of the analyzer Part 4 is the book OPERATION de Registers Tools 3 3 06 9 44 10 AM ne HumasStar 300 E UA RS Ready Human SP Diagnostics Worldwide 17 2 3 File Click to obtain a number of options as shown below File Registers Tools 2 Communications Move Archives Print gt Printer Setup b 2 3 1 1 Communications Enables to send and receive data Click to open the window that offers the below displayed options Communications COM 19200 n 8 1 E gs CC gx BM Ready to receve tests Fress OK tostat O by Serial Port Dee h O by Diskette p ot Store ir Bae Receive Worklist O Transmit Worklist O Transmit Results 2 3 2 The data can be transferred two ways via the Serial Port or via a floppy diskette Choose the way and proceed to a Receive a Work list b Transfer a Work list c Transfer Results The description above on the left 1 will indicate how it will be done when pressed OK The lower part in the window 2 will
39. be automatically saved and placed alphabetically among the other existing methods in the system To delete a method open that method click on EDIT and again on Delete Page A confirmation window will open click accordingly For Detailed Information see Chapter 3 3 92 Human HumaStar 300 User Manual Y toa F5 To Program a PROFILE e Click on F5 to open the Profile page Click on any existing Profile or any empty line with an asterisk to open the Left side page that displays all the programmed Methodologies available in the system An existing Profile will have its methods marked with v in their corresponding check boxes To program a new Profile click on an empty line on the right to open the opposite page with all the available programmed methods Click on the line Name on the left and introduce the name of the new Profile Go back to the right and click on the selected line to introduce that name Click on the check box of the methods that are to be part of that new Profile There are no limits of the number of Profiles that can be programmed To exit click the mouse on the BOOK cover The Profiles are automatically saved when the book is closed To delete a Profile simply highlight the Profile and press Key Delete on the keyboard A window will open for confirmation press Yes or No accordingly Click on F5 to open the Book to the Profile page For Detailed Information see Chapter 3 4 F6 STANDARDS
40. can be connected to the outlets AUX located in the back of the analyzer PARALLEL PORT PRINTER o SE ES 0 va vas au KEYBOARD coma wos gt 1 4 1 Human P Diagnostics Worldwide 5 1 4 1 Hydraulic Connections Follow example in Figure 1 4 1 1 1 a b c 2 a b WASH SOLUTION Fill container with 5 liters of dist water and add 1 500ul of Wash Additive cat no 18971 Mix slowly to avoid foaming Close the container with its screw cap containing the level sensor It will be flagged when the solution level in the container gets low however there will be enough solution to finish the programmed workload It is suggested to prepare the Wash Solution fresh every day and add to the container as necessary Once a week it is suggested to rinse thoroughly the Wash Container with distilled water before adding the freshly prepared Wash Solution INCUBATION BATH Fill the container with bi distilled water and close it with its screw cap and its level sensor When the Analyzer is turned ON the incubation bath will be automatically filled including its thermostat Both the temperature and the level of liquid in the incubation bath are continuously monitored Missing bi distilled water in the bath is automatically signaled and flagged To avoid formation of bacteria or other undesirable matter inside the water bath it is important that every two weeks this bi distilled water be drained and fresh one
41. concentrations have to be of the same Lot Number and have the same ID The Calibration Curve can be programmed two ways a Automatic Pre dilution from a concentrated Primary Standard Enter the name and ID the number of calibration points A page for each concentration will be automatically pre set Enter the concentration of the primary Standard There will be an automatic geometric pre dilution of the standard for the number of points programmed b Calibration Curve with individual Concentration Points Enter the name and ID the number of calibration points A page for each concentration level will be automatically pre set Enter the concentration of each individual calibration point on a separate page 3 5 2 To Delete or modify a Standard Value Simply highlight the Standard and press key Canc on the keyboard A confirmation window will open choose Yes or No accordingly To delete the Page click Edit and Delete Page A confirmation window will open choose accordingly To change the Value of a Standard click on its Value and change accordingly To save the modification close the book 42 Human HumaStar 300 User Manual 3 6 F7 Controls From the Main Menu click on Controls F7 to open its page There is no limit of the number of Controls that can be programmed Fie Edt Graph Navigation 2 Control Definition Lot number Expiabion date Method Bie BILTD Bil ot hem BUN CAL CHE CHOL CREAT D BILI
42. cs Worldwide 43 3 6 3 Quality Control Program After each calibration the results of all Controls are automatically memorized for the Quality Control Program To check view or print open the Book From the Main Menu click on F7 Controls Open the page to a desired control and double click on a method The OC pages will open The right displays the values obtained during Calibration and the left displays the curve and the values of Mean SD Standard Deviation CV Coefficient of Variation and Th CV which is the difference between the analyzed value compared to the Mean value programmed for that method The OC graph and its values are displayed for 60 days and are automatically updated daily To cancel a wrong value or an error highlight it and press Canc Ele Edt Graph Navi gt 4 3 2006 9 16 00 AM Gluc 114 220 mg dl Data Concentrazione Riferimento 12 4139 117 34 134 118 413 118 34 134 ne 194134 116 34 134 114 194 134 116 34 134 110 94 134 121 34 134 102 34 134 101 94 134 107 34 134 102 34 134 111 34 134 104 34 134 107 34 134 107 94 134 104 34 134 074 A 20 4 2004 5 5 2004 10 7 2004 3 6 3 1 3 7 Options Available Standard Options 3 7 1 Standard Options can be activated by the operator when needed 1 Use of Profiles enables to use the Profiles during Patient Entry 2 On Line Print Results enables to print while analyzer is in operation 3
43. culate results that have not yet been saved Select the test introduce the new FACTOR into the appropriate window and press OK EE 2 Select test insert a factor and then press OK Cancel to recalculate Warming the selected test will be declared vs factor ALT 2 5 4 Note The new Factor will be also memorised in the method If the method was originally against a Standard it will be automatically modified and become against FACTOR 6 Report Definition Enables to personalise the print of the final Patient Report Fle Registers Tods 2 2 21 05 501 07 PM ax Pinter Font Name DEES x Ge Header HUMAN Gemary OC Lato abiy Body Use mouse to size columns Test Name Result Flag Unk Value Flag Measurament Unit 160 High mgd Bold Bold Regular Right Center Left RH H Quality Control 2 5 5 22 Human HumaStar 300 User Manual 2 6 EDIT The following commands are available Ele Edit Graph Navigation 2 x RAN arm 11 Save amp Clear Page 2 Repeat Page Clear Page Save amp Clear All Samples Repeat All Samples Clear All Samples 2 6 1 1 Save Batch for enables to program a batch a number of samples for the same test 2 Edit Results 3 Repeat Row To repeat a Single test or Single Sample 4 Insert Page 5 Delete Page to delete a page 6 Save and Clear Page to save and delete results from a page 7 Repeat Page to repeat all tests of that page
44. d Control to open the left side page The methods that can be calibrated with that control will be displayed including their Reference Values and the results obtained during the last calibration As above simply click against the methods to be calibrated A V inside its check box indicates that the method has been programmed NOTE There can be more then one standard for the same method To make sure that its value is correct click on its line and its value will be displayed on the left side page There can also be one standard solution or Calibrator that is used to calibrate more then one method simply click on its line to display its values on the left and choose accordingly 4 3 3 Multi Standard Calibration Make sure to program each standard concentration individually Each concentration requires its sample cup and a place on the Sample Tray 1 to 14 Place the standards with an increasing concentration with the lowest concentration first In case of Automatic Geometric Standard pre dilution place only the Primary Standard followed by the number of empty cups necessary for the curve dilution 4 3 4 ISE Module Calibration Only if ISE Module is installed The calibration of the ISE module has to be done daily The Calibration is done together with all the other Standards and Controls but has to beprogrammed Make sure there is a V in the corresponding check box Should the Calibration fail go to Maintenance F8 Purge 3
45. e Edit Graph Navigation 2 2 21 05 539 53PM Standard Control Details E Calibration Standard Set Standard Ctl Type preDil Date Bias Reag bias May23 Alb o y Last value Reference 6 16 ISECAB std 4 3 1 Calibration identified with an enlarging lens it contains Serum Controls for a proper operation of the analyzer and for the Monthly Quality Control Program it is recommended to run daily at least one or two Serum Controls Standards and Calibrators 4 3 1 The Calibration page There are 14 Check Boxes corresponding to 14 places on the Sample Calibration reserved to hold the Standards and Controls plus four Stats 1 The Calibration page displays all the Standards and Calibrators programmed in the system To program a new Standard simply click on an empty line on the right to open the left side page Click on Type to select between a Standard or Control 2 Click on Name using arrows up and down choose the desired Standard or Control Click on every Check box that needs calibration 3 Click on its programmed position on the right to confirm The name and value of the programmed test will be displayed A V mark inside the check box indicates that it has been programmed Note A method can be calibrated with more then one Standard or Calibrator but the last one will be used for calculation 50 Human HumaStar 300 User Manual 4 3 2 To program a Serum Control for Calibration Click on the desire
46. e Level Sensor sometimes Check wash solution if volume is low air bubbles enter the does not work properly flags no system and may produce errors in the Level sensor fill hydraulics sample but there is sample in the with fresh wash solution cup Dirty Sample Probe and or with a sticking drop Foam or air bubbles on top of the sample Wash solution has too much foam that disturbs Check the Level Sensor connection 82 Human HumaStar 300 User Manual Reagent Level Sensor sometimes does not work properly flags no Reagent but there is reagent in the container The same as above for the Sample Make sure not to shake but slowly swirl the reagents when preparing Shaking reagents creates foam and air bubbles that disturb proper operation Make sure that the Reagent Container is not too full there should be NO Reagent in the container neck where the Level Sensor does work Human AP TT Diagnostics Worldwide 83 7 2 Spare parts and accessories Part No OTY Description 17939 1 Adapter for Sample Cups for cat no 17960 x 17944 1 Adapter for Tubes 12x75 17960 1 1 Sample Tray Segment A for 14 x 100 tubes 17960 2 1 Sample Tray Segment B for 14 x 100 tubes 17960 3 1 Sample Tray Segment C for 14 x 100 tubes 17960 4 1 Sample Tray Segment D for 14 x 100 tubes 17961 1 1 Sample Tray Segment A for 12 5 x 75 tubes 17961 2 1 Sample Tray Segment B for 12 5 x 75 tubes 17961 3 1 Sample Tray Se
47. e Triangle click to open a scrolling window that displays all the messages 2 10 Sub Programs F2 a F9 From the Main Menu click on any of the ICONS to access the sub programs F2 OPERATION gt 1 REAGENTS a User programmable positions of the Reagents El ON LINE b Reagent volume check number of tests displayed ii F2 c Reagent stability displayed and checked d Bar Code identification of Reagents optional 2 CALIBRATION to calibrate and or standardise the analyzer using standards calibrators and serum controls ae x 3 STATS program to run Stats 4 SAMPLES possibility to program up to 240 Patients at a time a User programming using keyboard and mouse i b Transfer worklist from host or from diskette 10 c Identification by built in Bar Code Reader Optional F3 ARCHIVE F3 Human PA o Diagnostics Worldwide 25 is Archive Selection Internal Archive Cancel O Archive on Diskette OK O Test Statistic Test Counter Last Warnings 2 10 1 1 Internal Archive saved Patient data on hard disk Data can be checked printed transferred or saved Choose accordingly 2 Archive on diskette enables the user to find data saved on diskette 3 Statistics enables calculation of statistical data on a group of results 4 Test Counter shows the number of test performed for each method 5 Flags amp Errors memorises all flags and errors for 90 day
48. e programmed Incubation 2 Diff Var Two Reagents Variable Differential Method the first measurement M1 is taken 12 sec before the addition of reagent R2 The final measurement M2 is taken after the programmed Incubation 2 Post R2 Two Reagents Method the first measurement M1 is made after 6 sec the addition of Reagent 2 The final measurement M2 is made after the programmed Incubation 2 Premix Two Reagent Method where Reagent 1 can be less then 300 pl However the final reagent volume has to be 300 ul or more The first measurement M1 is taken 6 sec after the addition of reagent 2 Reagent Blank Sample is added and final measurement M2 is taken after the programmed Incubation 1 Incubation 2 for this method must be 0 32 Human HumaStar 300 User Manual a Volume First Reagent R1 ul The volume of the first reagent is 300 pul the only exception is with method Post R2 and Premix b Volume Second Reagent R2 ul by default none This volume is programmable from 3 to 500 ul and is dispensed after Incubation 1 except Premix The volume of R1 R2 should not be more then 600 pl c Incubation 1 sec incubation time after the addition of sample into R1 Click to open and choose one of the pre programmed optimized times d Incubation 2 sec incubation time after the addition of the second reagent R2 Click to open and choose one of the pre programmed optimized times e Cooling select Yes o No
49. e reagent 3 4 q 2 Read Reagent cuvette Substrate depletion check M3 ul Add Reagent Add Sample 9 40 seconds Weg 10 36 62 88 114 140 166 192 218 244 270 296 322 Reagent preheating to 37 C About 90 Max Incubation gt seconds first turn plate Inc 1 114 Read Time 130 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Measure solution within 10 sec after addition of sample M2 5 Measure solution again 52 sec later to check for Substrate depletion M3 6 Incubation of sample example 114 sec or any other time 7 Read time for Kinetic measurement example 130 sec or any other time M4 8 CALCULATION is a Linear Regression based on the 130 sec measurement multiplied by its FACTOR KINETIC TEST 2 reagents 3l 1a N M3 o Read Reagent cuvette blank Mi N Measure solution within 10 6 N Check substrate depletion Add Reagent 2 Add Reagent Add Sample 9 40 ee A 10 36 62 ss 114 140 166 192 218 a 296 322 Reagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate e iaa gt Inc 1 62 Inc 2 78 Read Time 130 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 of sample example 62 sec or any time 5 Add Reagent 2 Starter 6 Measure solution wit
50. ed Time or Kinetic 2 The Optimized Incubation Times are displayed in the Table below a Tests with a Single Reagent the Incubation time indicates the time from the addition of sample to the final measurement b Two Reagent Tests Incubation 1 is the time from the addition of the Sample to the dispensing of the Second Reagent Incubation 2 is the time after the addition of the Second Reagent and the final measurement FIRST TURN OF REACTION PLATE Incubation time 1 in second 36 62 88 114 140 166 192 218 244 270 296 322 Longer incubation and Read Time Read Time 8 Incubation time 2 in second 26 52 78 104 130 156 182 208 234 260 286 312 LONGER INCUBATION AND READ TIME Incubation time 1 in Max incubation Timel 491 sec second 348 374 400 426 452 478 491 517 543 569 595 621 Read Time amp Incubation time 2 in second Max incubation Time2 585 sec 338 364 390 416 442 481 507 533 559 585 611 It is possible to use a longer incubation and reading times However this will slow down the throughput of the analyzer Human PA o Diagnostics Worldwide 39 3 3 3 Calculated Methods F4 From the Main Menu click on F4 and select Calculate Methods These are methods whose results are derived from a mathematical formula calculation based on results from other tests An example is A G Ratio File Edit Graph Navigation 2 Alb Glob FORMULA Expressi
51. elate the results with other methods or instruments By default the Slope is 1 and Intercept is 0 3 3 1 To Introduce or Delete a Method 6 From the Main Menu click Tools then Expert Mode Introduce your Password Click on F4 Methods to open the method Book Click Edit above A window will open that enables to Insert page to introduce a new method Delete Page to cancel an existing method Insert Page a new page will be opened Enter a short name or Code max 6 characters Click on the Code and program the new Method as described above all 3 pages Click on another method or close the book to automatically save the new method To delete an existing method select the method to be cancelled and click on Delete Page Awindow will open to request confirmation to cancel Answer Yes o No accordingly To Exit program click on Tools and choose accordingly 3 3 2 Examples of how to Program the Methods 1a End Point Single Reagent 1 Volume of Sample from 3 ul to 70 ul with a 1 ul increment 2 Pre dilution Ratio only if needed See the 15 pre programmed Ratios 3 Features None 4 Volume Reagent 1 from 300 ul to 600 ul 5 Incubation Time 1 Insert incubation time from table from 36 to 621 sec 6 Select if Reagent needs refrigeration 7 Enter Stability of Reagent or 999 8 Enter the Lot number only if necessary 9 Enter Bottle Type 1 or 2 10 Enter Re
52. ents xi Abs ContrNormal BUN 431 96 8 1485 1743 196 2251 2509 2767 3025 3288 Cancel Print Data details Ai 43 1 1 3475 0 0000 3 3 5 Program as above for Single or Two reagents with the exception of 12 Type enter Fixed Time 13 Read Time sec enter the time from the optimized table from 26 to 416 sec 15 Enter the value for substr Depl min the default value is 300 16 Calculation enter Factor Standard Multi standard etc All other parameters remain the same See graphic Presentation of the Method in Addendum Human z ze Diagnostics Worldwide ER 4 Kinetic Single or Two Reagents Determination the result is based on many readings and calculated by linear regression and linearity checks xl Abs ContrNormal AST al 1 5425 1 4850 1 1 3125 A 1 1975 1 1400 38C 41 8 93 7 147 1 198 4 2258 251 7 2775 303 3 3291 355 3813 Cancel Print Data details E 41 8 1 4777 0 0000 3 3 6 1 Program as above for Single or Two Reagents with exception of 12 Type enter Kinetic 13 Read Time enter the time from the optimized table from 26 to 416 sec 14 Reagent Blank Check mAbs Enter the values since they are checked to determine if the reaction is positive or negative By default the Negative Reaction will have a minimum Reagent Blank higher then 900 mAbs The Positive Reaction Kinetic should have a Min Reagent Blank lower then 700 mAbs 15 Subst D
53. epl min enter the value in mAbs for maximum linearity check It will depend on the linearity of the method measurement time and volumes of sample and reagent used When the measured mAbs min is higher then programmed the result will be flagged as SDP Substrate Depletion 16 Calculation although mostly determined by a Factor it can also be determined by a Standard If Factor is used enter its value on the line below All other parameters remain the same See graphic Presentation of the Method in Addendum 5 Multi Standard o Log Logit 1 2 They can be End Points Fixed Time o Kinetic Program all parameters as above with special attention to a The method has to be calibrated with at least 2 and usually with 6 standards with different concentration A maximum of 11 different concentration standards can be used for a Calibration Curve b Make sure to program each Standard concentration individually c The Standards have to be introduced with an increasing concentration All other parameters remain the same See graphic Presentation of the Method in Addendum 38 Human HumaStar 300 User Manual 6 Incubation and Measurement Times Both Incubation and the Measurement times have been optimized for maximum efficiency and they are based on the operational cycle of the analyzer which is 12 sec 1 Maximum throughput of the Analyzer is obtained when running Single Reagent Chemistries independent of type End Points Fix
54. es syringes glassware fuses diskettes tubing etc The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturers instructions altered in any way not specified by HUMAN not regularly maintained used with equipment not approved by HUMAN or used for purposes for which it was not designed HUMAN shall be relieved of any obligation under this warranty unless a completed installation warranty registration form is received by HUMAN within 15 days of installation of this product This warranty does not apply to damages incurred in shipment of goods Any damage so incurred shall be re ported to the freight carrier for settlement or claim 3 INTENDED USE OF THE INSTRUMENT The instrument has to be used for the expected purposes and in perfect technical conditions by qualified personnel in working conditions and maintenance operations as described in this manual according to the GENERAL SAFETY WARNINGS This manual contains instructions for professional qualified operators 4 GENERAL SAFETY WARNINGS Use only chemical reagents and accessories specified and supplied by HUMAN and or mentioned in this manual Place the product so that it has proper ventilation The instrument should be installed on a stationary flat working surface free from vibrations Do not operate in area with excessive dust Work at room temperature and humidity according to the specificatio
55. esired Sample in the Worklist 1 to 240 2 Onthe left are displayed all the results of the given Patient click on a Test result a Click on Edit and Repeat Row that single test will be repeated b Click on the desired Sample or Patient on the right and Repeat Row all the tests for that given Patient will be repeated c Click on the Patient on the right and then Repeat Page All 10 samples for that given test will be repeated Click on the Patient on the right and then Repeat all Samples all tests on that page will be repeated Human I o Diagnostics Worldwide 55 4 6 3 To Recalculate a Test against a New Factor GC Select test insert a factor and then press OK to recalculate Warming the selected test will bz declared vs factor LUC v fi OK 4 6 3 1 It is possible to recalculate the results of a whole test by introducing a new Factor a From the Main Menu click on Tools Click on Recalculate Result A window will open to introduce the New Factor o an Introduce the Code Name for the Test to be recalculated e Introduce the New Factor and press OK Note All results obtained that way will be flagged with the word Edit indicating that these are edited Results The method in case it was previously against a Standard will be corrected in the methodology against Factor and its new factor introduced 4 7 Print of a
56. gment C for 12 5 x 75 tubes 17961 4 1 Sample Tray Segment D for 12 5 x 75 tubes 17931 1 1 Sample Cup Adapter for cat no 17961 x 18720 31 1 Plastic Sample Cups Bag of 2000 18971 1 Wash Additive WAD 4 x 25 ml 17942 1 Container for ISE Standard A 17903 10 1 Compression Seals 5 pcs 17903 11 1 Sensor O rings 4 pcs 17903 1 1 Na Electrode 17903 2 1 K Electrode 17903 3 1 Cl Electrode 17903 4 T Reference Electrode 17903 5 1 Standard A 500ml 17903 6 1 Standard B 100ml 17903 7 1 Cleaner 125ml 17903 8 1 Urine Diluent 125ml 17903 9 1 Pump Cassette 17915 1 1 Syringe with Piston for Sample Diluter 17915 2 1 O ring for Syringe No 4 No 5 4 pcs 17916 1 1 Syringe with Piston Reagent Diluter 17916 2 1 Teflon Tubing with Connector for Probe 17934 1 Kit Tubing for peristaltic pump P 3 7 8 17933 1 1 Pump Tube Type 1 for P1 2 4 5 1 pcs 17953 1 Tube Connector for pumps P1 P2 17920 32 1 Photometer Lamp 17938 S 1 Reagent sample probe 17916 S 1 Teflon tubing w connector for probe 17950 5 1 Reagent container 50 ml with cap 17905 5 1 Reagent container 5 ml with cap 17906 5 1 Adapter for reagent container 5 ml 17950 6 1 Extractor for reagent container 50 amp 5 ml 84 Human HumaStar 300 User Manual 7 3 Suggestions and Warnings SUGGESTIONS To avoid to decrease the throughput of the analyzer we suggest to program methods with a total time lower than 322 sec 2 Before the start of the daily work refill co
57. going to be transmitted its format is 5 digits with leading space DataRecord is described in the Uploading and Downloading chapters Each field in the DataRecord must be distinct from the others with a separator char ASCII 124 hex 7C CheckSum is computed by adding the ASCII value of each pack characters from the HeadChar up to but not including the before the CheckSum itself It is transmitted in 4 digits in hex format with leading zeroes e g OEA2 Following is an example of CheckSum for a download prologue pack P 20122 Char ASCI Dec ASCI Hex P 80 50 CH 32 20 a 32 20 Sr 32 20 ir 32 20 we 32 20 2 50 32 290 122 CR stands for Carriage Return ASCII 13 hex OD Each transmission must start with a Prologue pack that indicates the total number of line to follow Example Prologue HeadChar 2 CheckSum CR Data HeadChar DataRecord CheckSum CR 66 Human HumaStar 300 User Manual Data HeadChar DataRecord CheckSum CR 5 4 4 To Transfer a Worklist Downloading from HOST or from a diskette The HeadChar is P and the DataRecord are formatted from the Table below Parameters Dimension Max Values acceptable PID 1 13 chars Empty Alphanumeric Family Name 2 16 chars Empty Alphanumeric First Name 12 chars Empty Alphanumeric Age 2digit Empty Number Sex 1 digit O Female 1 Male Accept Time 4 chars Format HHMM Comments 22 chars
58. h 1 Patient ID 2 Last Name 3 First Name 4 Comments open line to any desired comments 5 Sex amp Age use arrows to choose sex 6 Introduce Age 7 Type amp Time 8 Choose between Serum Plasma CSF or Urine 2 Below are displayed all the programmed methods in the system Choose the methods by clicking on its check box Make sure that the programmed method has the v inside Once all the desired methods have been programmed for a Patient click on a new line on the right for the next patient The data introduced is automatically saved 4 4 1 To Program Patients using Profiles From the main window click Options A window will open click on Use Profiles All the programmed Profiles will to be displayed during Patient Entry on the right side below its 10 Patients Human P Diagnostics Worldwide 53 4 5 To Programa Stat De Edt Graph Navigation 2 11 47 00 AM AutoCheck OK 4 5 1 The procedure is exactly the same as programming a Patient sample except it is done on the special STAT page The page is marked with a Red Cross with a Syringe on it There are four places reserved for STATS marked A B C and D Program and place the 4 samples into their corresponding positions on the Sample Tray These samples have a preference and will be processed immediately ki 54 Human HumaStar 300 User Manual 4 6 ToRun Patient Samples w Start Operations Searching operations H
59. he data and or Clear the pages for the next run a single page or all the samples To transfer or receive data click on FILE to open the menu Communication that enables to move to receive and to transfer data For details see Chapter 2 Click on F3 to open the BOOK on ARCHIVE which offers a number of important functions For details see Chapter 3 2 90 Human HumaStar 300 User Manual PRINT RESULTS 3 Results are automatically printed during operation per Patient However there is a PRINT program that enables to obtain different print outs that can be of great help to the operator Click on FILE from the Main Menu and then PRINT The following print possibilities are offered a Page the right side page on Patient Entry b Calibration data of the last calibration performed c Test Pending a list of all tests programmed but not yet executed worklist d Printout Results a window will open to display the options to print by Test Sample or Final Patient Report For details see Chapter 4 7 Human A TT Diagnostics Worldwide 91 F4 METHODOLOGIES Click on F4 METHODOLOGY There are two types of Methods 1 Regular Methods with an unlimited number of user programmable methods 2 Calculated Methods such as Test Ratios also user programmable The user may program or modify any method both the Regular as well as the Calculated The Parameters of each Regular method is program
60. heck Prepare a fresh solution or use pure dist Water Make sure that solution was dispensed into the cuvette Reaction cuvette dirty try Blank with another cuvette Repeat water blank Go to Maintenance and activate to repeat the water blank Check photometer lamp alignment Dirty solution in the incubation bath change Dirty reaction cuvettes Go to Measuring System maintenance and activate check box Clean cuvettes Reagent volume in cuvette too small Make sure there is at least a Human PA Diagnostics Worldwide 81 minimum of 300 l When checking Reagent Blank Check sample and reagent volumes Old photometer lamp change Badly connected Probes or torn tubing check Dirty Sample Probe clean Dirty or old wash solution prepare fresh Dirty solution in the incubation bath change The cuvette Washing station is not working properly Make sure there is wash solution and the probes go down all the way to the bottom of the cuvettes Make sure that the Air pump is working properly and drying the cuvettes as it should Make sure that the Sample Liquid Level Sensor works properly Serum controls not within expected Check controls for expiration date and correct lot number range Check method it may have been inadvertently reprogrammed Make sure that method conforms with reagent suppliers specifications Make sure the controls are not deteriorated Re assa
61. hin 10 sec after addition of Reagent 2 M2 7 Measure solution again after 52 sec to check for substrate depletion M3 8 Incubation 2 example 78 sec or any other time 9 Read time for Kinetic measurement example 130 sec or any other time M4 10 CALCULATION is a Linear Regression based on the 130 sec measurement multiplied Human Diagnostics Worldwide 101 DIFFERENTIAL TEST FIXED 1 2 3 fs 7 M2 M3 2 E g EE S E ak E cr 5 St al amp be F S E 5 E ro ba UI X x 5 E 5 3 SE 3 E S lt xo lt pe x 9 40 seconds Ea 10 36 62 88 114 140 166 192 218 244 270 296 322 Reagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate dic r Inc Time 2 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 SAMPLE BLANK is measured automatically within 10 sec after mixing of sample with the reagent M2 5 Incubation Time 1 variable See Incubation Table 6 Add Reagent 2 starter if necessary 7 Measure final reaction of sample M3 Set incubation as necessary for the method from the incubation Table 1 and or 2 CALCULATION of RESULT M3 M2 x FACTOR DIFFERENTIAL TEST VARIABLE USE ONLY WITH TWO REAGENTS Read Reagent cuvette M1 Add Reagent 2 starter Add Reagent 1 blank RB Add Sample Read End Point 9 40 seconds Reagent preheating to 37 C About 90 Max
62. i standard calibrator should be programmed the same way as a control where each concentration point should be individual checked to be programmed To Introduce a new Standard or Control into the Calibration Page Click on an empty line from 1 to 14 identified by an asterisk to highlight it and to open the left side page Click the line Type on the left and scroll to choose between Standard or Control All Standards and Controls programmed in the system are memorized Click the line Name then scroll to find the desired Standard or Control The Method or the Control will be identified and the previously programmed values displayed Click again the empty position on the right to assign ts place on the Sample Plate Once all the Standards and the Serum Controls have been programmed click the green triangle START A confirmation window will open click OK to Start Calibration After the calibration is completed check the results When in doubt repeat a standard or control accordingly The Controls will be used for the monthly Quality Control Program The green triangle START will be ON and the analyzer is ready for the next operation For details see Chapter 4 3 88 Human HumaStar 300 User Manual PATIENT ENTRY A Patient Entry can be done at any time While the analyzer is working or calibrating Patient Entry can also be done via RS 232 interface by a diskette previously prepared or simply type in the Patient data from the keyb
63. in to the position highlighted on the right The reagent will be programmed c The tests are performed in the same sequence as their Reagent position on the Tray The Reagent On Line Page contains the following information 1 Alittle Check Box with a number identifies the position on the Reagent Rack Reagent the name or code of the reagent Test indicating the number of tests available in the reagent bottle Stb hrs stability of the reagent in hours Bottle type 1 50mlor 2 5 ml Cool the Yes indicates that the reagent should be placed in the Tray WN ul 9 gt e e Note The Tray is cooled to maintain better the reagent stability It is not a refrigerator and is turned OFF together with the analyzer 7 To Exit click on Navigation than click again on Close register or simply click on the Book cover 4 2 1 Check Reagent Volumes for the Daily Run lig Fo DE Upeai wm Searching opershors Ce F3 Na martenance request 3 no warrungs present amp F4 Reagent Volume Chack Press OK to conti and stat operation SE q Se e CW Ready A E gt EPM Option changed 4 2 1 1 Open the BOOK to Reagents On Line and make sure that all the reagents that are to be used for the day are programmed there is a Y check in its box 1 When the GREEN triangle below is ON click START gt 2 A window will open Check Reagent Volume Click OK to START Reagent
64. indicate what is being transferred or received ATTENTION The system will transmit all the data that it holds in memory It is suggested to cancel all the old results before transferring new data To cancel results after having transferred them go to F2 Work List Choose Modify and then click on Save and delete all Samples or clear all samples 18 Human HumaStar 300 User Manual 2 Tosave a monthly Archive Enables to transfer data by month from the Hard Disk onto a floppy diskette It is suggested to use a separate diskette for each month 21x Select month to move insert a diskette Fr into floppy drive and then press OK to continue My 5 3 Print There are the following options a Page page shown in the book b All Pages like all pages of the methods c Calibration Results of the last calibration performed d Test Pending All programmed tests not yet performed or Work List e Print Result results for a given work list A window will open Follow instructions as indicated Results Printout Selection x L O List by Test O List by Sample O Print by Report From Position 11 X To Position 2 3 4 f Sample Reports print a selected number of reports from a Worklist or from Archive 4 Printer Setting enables to install or choose a new printer 5 Exit to end operation and to Turn OFF the Analyzer Human P Diagnostics Worldwide 19 2 4
65. ing check boxes c To Exit click on the book cover or on Navigation to close the book The Profile is automatically saved 3 4 2 To Delete a Profile Simply highlight the Profile to be cancelled and press key Canc on the keyboard A window will open for confirmation press Yes or No accordingly Human A ze Diagnostics Worldwide 41 3 5 F6 Standards From the Main Menu click on Standards F6 to open its page There is no limit to the number of Standards and Calibrators that can be programmed Fie Edt Graph Navigation 2 Standard Definition Relaranca Lot MunStd ID Expiration date 02 21 10 Avalable tests ALB Method Vabe Factor Last Date ALK GLUC 100 ALT AMY AST BiDe BILTD Bill ot BUN CAL CHE CHOL CKNAC CREAT D BILI GGT IRON LOH 3 5 1 To Program a New Standard Click on Edit and then Insert Page In the window enter the name of the Standard its lot number if available and the number of calibration points On the right select the method insert the expiration date and click on the line with the asterisk On the left side are displayed all the available methods Click on the method and then on the right side on the asterisk On the top left enter the concentration for the Standard Then click on the right to save the value If it is a Multi calibrator it is possible to enter several methods that are standardized against a single Calibrator Note In case of a Calibration curve all the
66. ing codes EEN 59 5 1 2 To identify the samples with the Bar Code EEN 59 52 Reagent ldentification u ee men 61 A UE 62 Sisal OOMEN so EAEAN EE EAE AAA 62 ii iii Human HumaStar 300 User Manual 5 3 2 AAA 63 5 3 3 Important NOTES eussssasseissascassaseassnssassnsssassasssassasscassnsscassnsscnssnssnssnsscnssnschsehdesnssnnssnssnsshsehssshssnsschsehssshsed esdsehisnnsshissnsshisteee 63 5 34 Testing Procedure unse 64 e A A Se SS EAA E ENEE 64 53167 Trouble Sno tins the SE MOU e AANEREN 64 5 4 Data Exchange with Host Computer EEN 66 5 41 OA US A to 66 5 4 2 Connection from Host Computer To HumaStar 200 ENEE 66 E RO 66 544 To Transfer a Worklist Downloading from HOST or from a diskette inicie 67 5 4 5 Transfer Results Transmission to HOST or Diskette ccecccsssssccsssseecssssssccsssssecssssuseccssssessessusessssssecsssseecsessseecsssseees 68 6 Maintenance RR sn 71 6 1 Reagent SyStem ii a A 71 6 2 Sample System EEN 72 EE RE EE E A ee ee 73 6 4 A TO 73 6 5 Maintenance every TWO weeks EEN 74 6 6 Operation to be done every 2 months 74 EE INTEN DEE 75 6 7 1 Change Photometer Lamp See 6 7 1 1 cocidos 75 6 7 2 Drain and Fill the Incubation bath see 6 7 2 1 cccccsssssssssssecsssssessssssecssssssecssssscssssssecssssuscssssssccesssssccessueecessueeesssseeesses 76 6 7 3 Check Incubation Temperature 76 6 74 Change the Sampling Probe See 6 7 4 1 sssini 77 6 7 5 Change Tubing on Peristaltic Pump 78 6 7 6 Repl
67. interventions HUMAN Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 61 22 99 88 0 Fax 49 61 22 99 88 100 e Mail tech support human de www human de Human PP o Diagnostics Worldwide Contents 1 General Description RR 1 Lo A NR 2 EC EN El Lu E 3 A GBR 4 E dn 4 13 2 Installation A 13 3 Environmental Reg ultetretttes ee A 1 34 Operating Temperature DIE eet A 1 3 5 Power Requirements ENEE 4 O A O 5 LAI veraltet Ee HOENEN 6 15 A RN tits 7 EE e EE 7 1 5 2 Analytical Plate and its incubation thermostatic bath EEN 8 1 9 3 Cuvette EIN E 9 154 ENEE Washing Kreeser 9 1 55 Samples 10 1 5 6 A RAT 11 o Sample YI eier 12 A EE UE AAA RR 12 15 9 D NE poi Gr SE a RR RR RR RR RR O O 13 1 5 10 N E 14 1 5 11 Dlterro Eeer 15 2 1 2 2 2 3 2 4 2 5 2 6 227 ET 24 Dido E 25 2 9 Analyzer EH 25 2 10 UR E eer 25 2 11 User Personalized Programs arar 26 2 12 Important fUNCtIONS cinc ani 27 TOEAU A A NN 29 E EE 29 3 2 e ATA O 30 A A A 30 3 341 To Mtroquce orDelete Method iia OS 35 3 3 2 Examples of how to Program the Methods ENEE 35 333 E EE 40 ES E Wl 41 34 To prostamia ne WR FONO eege 41 342 To Delete Oe UE 41 3 5 E E 42 3 51 ToPrograma New Standard AAA TN 42 3 5 2 Mo Deleteormodihya Standard Va lUe issnin EEE 42 A AR O QUE O SPA NPR ROS DO NRO ANNE ANI EN 43 3 6 1 To Program a New
68. laboratory glassware such as Extran from Merck or any other similar product Use it instead of the bi distilled water 2 Use the procedure in Maintenance program to DRAIN and FILL Liquid Bath with the detergent 3 Leave the detergent liquid in the bath for at least an hour 4 Rinse well several times with bi distilled water and finally fill it with good quality bi distilled water 74 Human HumasStar 300 User Manual 6 7 6 7 Analyzer Maintenance 1 Change Photometer Lamp See 6 7 1 1 Operation to be done with Analyzer OFF Oy A E Remove the rear panel Disconnect the lamp cord from the power supply board Remove screw holding lamp Remove knob ADJ Horizz Remove lamp and place the new one Note do not touch the glass part of the lamp with your fingers use the plastic envelope to hold the glass part Proceed in reverse to lock well the screw 8 Turn ON the Analyzer 10 11 12 13 14 Pipette 500 ul of distilled Water into cuvette 38 Go to Maintenance F8 Reading System select Photometer Test Click INIT to initialize the system Click START Cuvette N 38 will position itself in front of the photometer and measurement will start at 340 nm for approximately 80 sec The Transmission will be displayed Adjust the horizontal knob loosen and rotate the vertical cam 1 or 2 to obtain an optimum value of 60 e 90 the measurement time will stop when the Transmission will be s
69. lick on the desired reagent on the left then click again into a free position on the right The new desired reagent will be automatically programmed A v mark is its check box means the reagent is programmed for the next run The reagent volume in each container is constantly monitored during operation Before starting the actual run an automatic Reagent Volume Check is performed The number of Tests Available in every reagent container is displayed together with other pertinent information To check the reagent volume click START the green triangle and window will open If no maintenance or other operational requests are displayed click OK to confirm REAGENT VOLUME CHECK Human TT Diagnostics Worldwide 87 Should the START triangle not be visible close the Book or change page to display it The REAGENTS ON LINE page will display for all the checked reagents 1 The position of the reagent on the Reagent Plate 2 The number of the tests available in each reagent container 3 The size or type of the container to be used 4 The stability of the reagent in hours 5 If reagent requires cooling or not 6 Double click on a Reagent to display its last Calibration Curve Reagent volume checks are made only once a day when programming the daily workload or at any time when reagents are added or changed Once the reagent check has been completed the instrument will be READY for the next operation and the Green t
70. med on 3 pages Page 1 includes the name Units Reference Values Linearity Limits and Quality Control checks Page 2 contains the parameters for sample and reagent volumes special features incubation times and the wavelength filters etc Page 3 Contains parameters for Reagent Blank checks substrate depletion for enzymes reaction types measurement including various calculation modes and linear correlation The Calculated Methods are programmed separately They offer a standard formula enabling the operator to program a combination of various ratios that are automatically calculated and results presented in the final Patient Report For more details see the Chapter 3 3 There is also a set of methods as an example supplied with the analyzer Click on F4 METHODOLOGY Note To access the Methodology program requires a Password From the Main Menu click TOOLS and then Expert Mode a window will open that enables to introduce the password F4 To Program a New Method e Click F4 Methodology to open the Book after having introduced the password Click EDIT and again Insert Page for new method A window will open enabling to introduce a short name or code for the new method with maximum of 6 characters Introduce the new name and click OK Proceed to program all the parameters for that method After having introduced all the data simply click on another method or close the diary book The new method will
71. mmed These samples can be inserted onto the analyzer sample tray at a later time or whenever convenient To introduce new samples while analyzer is in operation press the Intelligent STOP the red square For details see Chapter 4 4 STAT OPERATION If during routine operation it is necessary to run a STAT click F2 to open the Book Click on page 3 STAT which is marked with a syringe and a red cross To introduce the STAT sample into the sample plate it is necessary to STOP the analyzer Click on the RED square STOP and wait until the analyzer stops and the green triangle START is lit This is an intelligent stop the Reagent probe stops dispensing and the Sample probe finishes its programmed cycle The already prepared samples continue to be measured and processed in the reaction plate No samples is lost There are 4 positions on the inside of the sample plate reserved for STATS They are marked D C B and A to processed in this sequence While waiting for the analyzer to STOP which will take about a minute and half go to the STAT page and program the desired STAT samples Up to 4 STAT samples can be programmed at a time The procedure is exactly the same as programming a Patient sample When the green triangle START is lit open the plexiglas cover and place the Stat sample into their programmed positions on the Sample Tray Click START to continue operation The START OPERATION window will open Make sure that
72. mpletely the container for the pre dilution 3 Use mono reagent methods 4 Do not fill the reagent containers of 50 ml with less than 2 5 ml of reagent and the reagent containers of 5 ml with less than 0 5 ml of reagent The reagent could place itself in the corners of the container modifying the real number of the test 5 To activate LIS communication select F9 print ON LINE 6 There are 4 positions on the inside of the sample plate reserved for STATS They are marked D C B and A to processed in this sequence WARNING DURING THE OPERATION A B c D E F G Do not open the cover in Plexiglas Do not remove the pre dilution container Do not remove reagent and sample tray Do not move the caps of the Wash and Incubation containers also if flagged wait the END OF RUN Do not delete METHODS STANDARDS or an CONTROLS Do not deselect ii STANDARDS and CONTROLS during the calibration Do not modify the setup of clock and calendar for avoiding to modify the data of calibrations and controls Human PA Seeg Diagnostics Worldwide 85 7 4 OPERATION Change distillated water for incubation analytical chamber Clean analytical chamber Cleanm reading cuvettes Replace syringe type 4 and 5 cylinder and piston Replace tubing pumps P 3 P7 P8 Replace tubing pumps P1 P2 P4 P5 Replace pumps cartridge P 3 P7 P8 Replace pump P6 Replace photometer lamp Clean optical assay Check probe alignment Check
73. n cuvettes to assure a non stop operation DIRECT READING a built in multi filter photometer measures each sample every 12 seconds at 8 different wavelengths There is a reagent cuvette blank for every sample to eliminate the possibility of errors 1 S E MODULE is built in for the determination of Na K and Cl together with the routine chemistries Optional AUTOMATIC REPETITION OF RESULTS results that are outside of linearity range or suspect of substrate depletion are automatically repeated with half its sample size REAGENT VOLUME only 300 ul of reagent is sufficient to run any test KEYBOARD a full keyboard for easy programming and patient data input USER FRIENDLY SOFTWARE with graphic presentation makes the analyzer easy and simple to operate The operator is guided step by step through all operations including an On Line HELP program ON LINE HELP a program to help the operator during operation and programming OPEN SYSTEM an unlimited number of Chemistries and Immunoassay methods Profiles Standards Calibrators and Controls are all user programmable including automatic calculations of Ratio methods ON LINE QUALITY CONTROL checks the precision during standardisation and presents graphically a 60 day Quality Control program with calculated MEAN Standard Deviation CV and theor CV STATS are processed within 6 minutes without interfering with the routine testing PATIENT REPORT are user pers
74. ns listed in this manual Do not operate this instrument with covers and panels removed Only use the power cord specified for this product with the grounding conductor of the power cord connected to earth ground Use only the fuse type and rating specified by the manufacturer for this instrument use of fuses with improper ratings may pose electrical and fire hazards To avoid fire or shock hazard observe all ratings and markings on the instrument Do not power the instrument in potentially explosive environment or at risk of fire Prior to cleaning and or maintaining the instrument switch off the instrument and remove the power cord For cleaning use only materials specified in this manual otherwise parts may become damaged It is recommended always to wear protective apparel and eye protection while using this instrument Respective warning symbols if appearing in this manual should be carefully considered Human P Diagnostics Worldwide 5 DISPOSAL MANAGEMENT CONCEPT The currently valid local regulations governing disposal must be observed It is in the responsibility of the user to arrange proper disposal of the individual components All parts which may comprise potentially infectious materials have to be disinfected by suitable validated procedures autoclaving chemical treatment prior to disposal Applicable local regulations for disposal have to be carefully observed The Instruments and electronic accessories with
75. o check the temperature inside the cuvette proceed as follows 1 The analyzer should be ON at least 10 min before starting the test 2 Dispense 500 ul of dist Water into a reaction cuvette 3 Place a thermometer probe into the cuvette and wait about 90 sec before starting to measure Use a thermometer with a small 1mm thermocouple not to distort the measurement 76 Human HumasStar 300 User Manual 6 7 4 Change the Sampling Probe See 6 7 4 1 Operation to be done with Analyzer OFF 1 Removethe Sample Probe and remove the screw to lock the probe 2 Disconnect tubing by rotating the TIP anti clockwise 3 Place the new Probe and make sure to lock well the TIP 6 7 4 1 Sampling Arm Human 2 ze Fe Diagnostics Worldwide 77 6 7 5 Change Tubing on Peristaltic Pump Operation to be done with Analyzer OFF 1 Remove the screws 4 2 Remove the support 5 3 Change tubing 3 cod No K10034 01 4 To reassemble repeat the operation in reverse Note Use only the original tubing from Human Other types of tubing will alter the volumes dispensed and cause inconveniences in operation of the analyzer IN 6 7 5 1 Peristaltic Pump 78 Human HumasStar 300 User Manual 6 7 6 Replace the Syringe Operation to be done with Analyzer OFF Follow the figure below 1 Remove the plastic locking screw of the Piston 4 Remove the locking screw 5 to easier remove the syringe UU N Make sure not
76. oard Up to 240 Patients can be programmed at a time with an unlimited number of chemistries However there are only 30 On Line Reagents at a time Click F2 to open the Book Click on page 4 indicated as 1 10 Samples Each page contains 10 samples corresponding to one segment on the Sample plate The number on the page corresponds to the number on the Sample Segment To program a Sample click on the first line or any line to open the left side page that displays the patient Introduce the patient demographics or sample data All the available programmed tests or methods in the system are displayed To choose a methods click its check box A v mark inside its check box indicates that the method has been programmed It is also possible to program by Profile Instead of programming one test at a time click on a Profile and then the corresponding sample number The data introduced will be automatically saved To program by Profile activate in Options F9 Once a certain number of samples has been programmed place them on the Sample Tray and START the analyzer Click the green triangle A START window will open If no maintenance or other operational requests are displayed it will identify the Racks and the sample numbers that are programmed click OK to confirm If there are sample that require pre dilution do not forget to introduce its dilution ratio before START While the analyzer is working more patient samples can be progra
77. ol highlight it and simply change its values To exit press the book cover The programmed Controls are automatically saved For Detailed Information see Chapter 3 6 F7 Quality Control Program Click F7 to open the BOOK with all the available programmed Controls All Serum Controls performed during calibration are automatically memorized for the monthly Quality Control Program Each method has its own OC page and its own graph To check view or print the OC page click twice on the desired method to open its OC program pages The right side displays the values obtained during calibration and the left displays the curve with the values of Mean Standard Deviation and Coefficient of Variation Click twice on the graph to display a larger version of the graph with its details displayed in the window below Scroll to display its OC values the graph and its values The Q C values are displayed for only 60 days and are automatically updated daily The QC sheets and the graphs can be printed For Details Information see Chapter 3 6 F9 OPTIONS Click on F9 to open OPTION page There are a number of options available with the system Some of those options are part of the standard software There are others that require the addition of modules or extra parts and are optional not available with the standard Analyzer system The Standard Option can be activated or deactivated directly by the user as necessary These are
78. om time to time For Detailed Information see Chapter 6 SPECIAL FUNCTIONS N There are some special function that apply to allthe programs in the system there are Use ofthe mouse The mouse is an integral part in the operation of the analyzer All operations with the exception of Patient and other data Entry are done with the help of the mouse In the instructions the use of the mouse will be referred as CLICK point with the mouse to the indicated item and CLICK to execute the order Menu Items On the top right ofthe Main Window there are 5 special functional menu keys that are an important part in the operation of the analyzer Some of these functions are operative only in combination with certain programs These are as follows FILE It offers a number of sub commands such as Communication Move archive Print Printer Set up and Exit to shut down the system REGISTERS contains the 8 programs from F2 to F9 TOOLS contains the following sub programs Expert Mode Instrument Init Prepper for sample pre dilution To Load Sample Rack Recalculate Results Report Definition Set Date and Time EDIT offers 13 functions necessary during programming and operation of the analyzer NAVIGATION offers some commands useful during programming HELP On Line Status of the Analyzer There are 3 important icons on the bottom of the Main Menu that identify the status of the analyzer START
79. on A A B Use A B Cor D to indicate below Tests A Test ALB B Test T P C Test D Test 3 3 3 1 To program a test click on Edit and then Insert Page Enter the name of the new method followed by the parameters requested on page 1 On page 2 enter the formula to calculate the new method A total of 4 tests are available to calculate the new method A B C and D Example is A G Ratio A Albumin and B Tot Protein On the line Expression enter the formula A A B To cancel a method click on its name Go to Modify and select Cancel Page 40 Human HumaStar 300 User Manual 3 4 F5 Profiles From the Main Menu click on Profiles F5 to open ts page On the left are displayed all the available programmed methods in the system There is no limit to the number of Profiles that can be programmed Ele Edt Graph Navigation 2 2 21 05 5 19 02 PM Name Diabetes Avalable tests D BILI GGT vi GLUC vi IRON v LDH MAGN PHOS CJTBIU v TP Test Teitfla v Ted TRG vi UA 15 16 42 PM Auto Cheek OK D 3 4 1 3 4 1 To program a new Profile Click on the asterisk on the right side page a Click on the left on the line Name enter the name of the new Profile Go back to right page and click on the previously selected line to introduce the new name b On the left are displayed all the available methods Choose the desired methods for that Profile by clicking on their correspond
80. onalised printed and automatically saved on a hard disk BI DIRECTIONAL INTERFACE via built in a RS 232 C connection to EDP systems 2 Human HumasStar 300 User Manual 1 2 Warranty HUMAN warrants that instruments sold by it or by one of its authorised dealers shall be free of defects in material or workmanship provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser HUMAN shall replace or repair any defective item at no charge except for transportation expenses to the point of repair This warranty excludes HUMAN from liability to replace any item considered as expendable in the course of normal usage e g lamps valves syringes glassware fuses diskettes tubing etc HUMAN shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer s instructions not regularly maintained used with equipment not approved by HUMAN or used for purposes for which it was not designed HUMAN shall be relieved of any obligation under this warranty unless 1 Acompleted installation warranty registration form is received by HUMAN within 15 days of installation of this product 2 The Buyer within the applicable period of time returns the defective product or part thereof freight pre paid at Buyer s expense to HUMAN This warranty does not apply to damages incurred in shipment of goods
81. ons During installation at least one person in the laboratory will be trained in operation and maintenance of the Analyzer The HumaStar 300 is a highly sophisticated high precision sensitive instrument Proper installation will ensure optimum performance 1 3 3 Environmental Requirements The system should be mounted on a table or workbench in an area free from vibration draughts dust strong magnetic fields or direct sunlight 1 3 4 Operating Temperature Limits Ambient room temperature from 15 Cto 32 C max humidity 65 non condensing 1 3 5 Power Requirements A standard 115 230 V 50 60 Hz 500 VA power is required as indicated on the back of the instrument A 2 wire outlet is used to assure proper electrical grounding If the laboratory power supply varies by more than 10 It is recommended to install an external stabiliser an On Line UPS with a minimum rating is 600 VA 4 Human HumaStar 300 User Manual 14 Assembly The Analyzer is supplied assembled and ready to use However it is important that the installation be done by authorised personnel only The instrument should be internally examined to check that no damage has occurred to any of the electronic boards or mechanical parts during shipment Then proceed to install the external parts as follows Monitor Printer Mouse Keyboard Waste Container Wash Solution Container Container of liquid for the Incubation Bath See Figure 1 4 1 The Monitor and the printer
82. or carry over A standard B sol n and a Clean sol n cups are placed on the calibration Rack necessary for calibration 5 3 1 ISE MODULE 5 3 1 Some Characteristics Characteristics Whole Serum or Plasma is used Small Sample size only 60 ul Electrodes are mounted close to the electronics to minimise electronic noise and improve precision Sample deposit near the ISE sensors for a rapid electrolyte result Rapid operation only 30 sec cycle time Simple Maintenance Easily accessible pumps and electrodes for maintenance and service Two bubble detectors to assure reliability Two point calibration to assure precision One point calibration with every sample Maintenance free Electrodes for 6 months or 10 000 sample warranty Disposable reference electrodes no additional filling required 62 Human HumaStar 300 User Manual 5 3 2 Technical Specifications Sample Volume Sample Reproducibility Serum Na K Cl Analysis Time Throughput serum Serum plasma or dilute Urine 60 ul 160 ul for diluted Urine 1 10 Maximum imprecision within run Typical Carry over serum CV lt 1 5 100 160 mmol L lt 0 5 CV lt 2 3 00 6 00 mmol L lt 1 5 CV lt 2 80 0 120 0 mmol L lt 1 0 serum 30 seconds including one point calibration urine 60 seconds including one point calibration 90 x3 samples per hour urine 45 samples per hour 5 3 3 Im
83. orldwide 9 1 5 5 Sampling Arm The Sampling arm holds the probe that is connected to the diluter which aspirates and transfers both the sample and the reagent into the reaction cuvette and mixes at the same time During its operating cycle the probe can move to its various positions Samples Reaction cuvette Washing Position Sample Pre dilution Container and into the ISE Module 1 5 5 2 Reagent Arm 10 Human HumaStar 300 User Manual 1 5 6 Reagent compartment REAGENT CAPACITY 30 On Line reagents each reagent can be cooled or left at room temperature The large reagent bottles hold 50 ml and the smaller reagent bottles hold 5 ml REAGENT COVER 1 5 6 1 Reagent Tray Human L zeg Diagnostics Worldwide 11 1 5 7 Sample Tray SAMPLE CAPACITY 40 On Line primary tubes or small sample cups on 4 independent sector See Fig 1 4 9 1 plus 20 positions for Standards Calibrators Controls and STATs Each sample has a corresponding place for a cup for automatic pre dilution if necessary For details see Chapter 6 PREDILUTION CUP PRIMARY TUBE SAMPLE SEGMENT SAMPLE SEGMENT 14 PLACES FOR STANDARD AND CONTROLS 1 5 7 1 Sample Tray 1 5 8 Probe Washing Station It is of utmost importance that the Probe is properly cleaned after each operation to avoid both carry over and contamination This washing station has been especially conceived to wash the probe both internally P1 and P2 and exte
84. out batteries power packs etc must be disposed of according to the regulations for the disposal of electronic components Batteries power packs and similar power source have to be dismounted from electric electronic parts and disposed off in accordance with applicable local regulations 6 INSTRUMENT DISINFECTION Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrument is removed from the laboratory for disposal or servicing it must be decontaminated disinfected Decontamination disinfection should be performed by a authorised well trained personnel observing all necessary safety precautions Instruments to be returned have to be accompanied by a disinfection certificate completed by the responsible laboratory manager If a disinfection certificate is not supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument by the servicing centre or from authority s interventions 7 NOTICE Every effort has been made to avoid errors in text and diagrams however HUMAN GmbH assumes no res
85. ponsibility for any errors which may appear in this publication It is the policy of HUMAN GmbH to improve products as new techniques and components become available HUMAN GmbH therefore has to reserve the right to change specifications if necessary in the course of such improvements NOTICE Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious emm UY BIOHAZARD The BIOHAZARD warning label must be affixed to instrument prior to first use with biological material Servicing Note Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrument is removed from the laboratory for disposal or servicing it must be decontaminated Decontamination should be performed by authorised well trained personnel only observing all necessary safety precautions Instruments to be returned have to be accompanied by a decontamination certificate completed by the responsible laboratory manager If a decontamination certificate is not supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument by the servicing centre or from authority s
86. portant Notes 1 Power Supply of the ISE Module The ISE module remains ON at all times even after the analyzer is turned OFF The ISE electrodes have to be kept moist at all time even during the standby periods Every 30 min a small volume of Calibrant A is automatically pumped through the electrodes to keep them moist and ready to operate The ISE module is directly connected to the power supply 2 Reagents 1 Calibrant A Cal A is used as reagent wash and one point calibration is being consumed at a rate of approx 24 ml a day That includes 100 samples of Na K and Cl in an 8 hour day plus 16 hours of standby 2 Calibrant B Standard Cal B for calibration only is used as the second point calibration It is used as a Standard during calibration consumption approx 400 ul a day 3 Cleaner used only once or twice a day to clean the electrodes and to eliminate protein build up It is used as a sample during calibration consumption approx 400 ul a day 4 Urine Diluent Needed only for the dilution of the Urine samples Urine samples must be pre diluted 1 10 with this diluent before testing ISE MODULE SERIAL CABLE 5 3 3 1 Diagram of the ISE Module Method for the ISE Module The determination of the three methods Sodium Potassium and Chloride does not need any special method Introduce only the Reference Values allthe rest is programmed inside the module Human A TT
87. r control To fill the smaller container with the liquid for the incubation bath To empty the Waste Container then place 20 ml of Sod Hypochlorite CAL A only if ISE Module is built in place a full container with Calibrant A next to the module and close with its liquid sensor anos Turn ON the Analyzer it will perform all the necessary Auto Checks when the green triangle is lit the analyzer is ready for operation 4 2 Reagents Click on F2 OPERATION The BOOK will open on the Reagents On Line Page On the right are displayed all the reagents that have an assigned place on the Reagent Tray Click the mouse on any line to open the left side page On the left are displayed all the remaining programmed methods that have not been assigned a place on the Reagent Tray File Edt Graph Navigation 2 Available Reagents Reagents On Line Set Reagent Test Sib by Bott Cool E EA v2 v3 va v 5 v 6 vi EA EE w 10 ivi 9 12 py xe 5 a 8888888888888 Nada y ot pa ya Human z ze Diagnostics Worldwide 47 To program Reagents for the daily run 1 Simply click on the Check Box for the reagent to be used 2 If the reagent has not yet been assigned a position on the Reagent Rack or it is necessary to change its position proceed as follows a Click on an empty line with an asterisk Cl on the right to highlight the line b Click on the left on the method to be programmed then click aga
88. riangle START will be ON For details see Chapter 4 2 SH F2 CALIBRATION 24 Once the Reagents have been checked the next step is CALIBRATION Click the mouse on Operations F 2 The Book will open Click on the enlarging lens to open the Calibration page There are 14 positions displayed corresponding to the 14 places in the center of the Sample Plate reserved for Standards Calibrators and Controls numbered 1 though 14 Places 15 and 16 are reserved for the ISE use only All the previously used Standards and Controls are displayed To choose a Standard for calibration click on its corresponding check box A v mark inside a check box indicates that the corresponding Standard Calibrator or Control has been programmed To check the details of a standard or calibrator simply click on its name to open the left side page The standard is identified including its concentration and its optical density or Factor obtained during its previous calibration To check the details of a Serum Control click on its name and the left side page will display all the chemistries including their reference values as well as the value obtained during the last calibration To program a Serum Control for Calibration click the mouse on the desired control to open the left side page All the methods are displayed Click the check box of the methods to be calibrated A v mark inside its box will indicate that the method has been programmed A mult
89. rnally by pump P4 and a final air jet cleans and dries the tip of the probe from any residue of wash solution A Te ve PSN SS AD 3 WASH SOLUTION 1 5 8 1 Washing Station 12 Human HumaStar 300 User Manual 1 5 9 Diluter A high precision Diluter connected to the Probe transfers both the sample and reagent User programmable volumes are possible from 3 ul to 70 ul for sample and 3 ul to 600 ul for reagent with 1ul increments The peristaltic pumps P1 and P2 mounted in series with the Diluter washes both the Probe and its connecting tubing after each operation The volume of wash has been optimised to assure a perfectly clean operation 1 5 9 1 Human EE i Diagnostics Worldwide 13 1 5 10 Peristaltic pumps 4 PERISTALTIC PUMPS TO RINSE THE PROBE 1 5 10 1 The four peristaltic pumps below serve as follows P1 Washes the sample tubing and its Probe inside P2 Washes the reagent tubing and its Probe inside P4 Washes both probes externally P5 Solution to wash the cuvettes 14 Human HumaStar 300 User Manual 1 5 11 Photometer A multi filter photometer using 8 narrow band interference filters has been conceived to offer maximum sensitivity accuracy and stability of measurement The following 8 standard interference filters have been built in 340 380 405 510 546 578 620 and 700 nm 674 020 00 1 5 11 1 Photometer Human Ke L zeg Diagnostics Worldwide 15 16 Human HumaSt
90. rom 26 to 416 seconds 11 CHECK ABSORBANCE mAbs enter the Min and Max forthe Reagent Blank These values are important in both calibration and routine testing especially important in the determination of Enzyme Kinetics Any anomaly will be flagged a Substr Depl min Substrate Depletion used only for Enzyme Kinetic Determinations Enter the max value in mAbs of the method linearity Every Kinetic measurement is checked for Substrate Depletion and Linearity A measurement is taken 6 sec after the addition of sample into the reagent and again 60 sec later If enzyme activity is larger then programmed it will be flagged as SBD When the Automatic Repetition of Results is active the test will be repeated automatically with half its sample size and result corrected accordingly 12 CALCULATION a Calibrate click to open the options a Factor b Standard c Multi Standard 34 Human HumaStar 300 User Manual c Log Logit d Log Logit Cubic b Factor If method is to be determined against a known Factor enter its value The tests that are determined against a Standard or Calibration Curve select accordingly The actual values for those parameters should be programmed in F6 Standards c Reag Bias Subtr Select Yes or No This is a Reagent Blank correction performed during calibration and will be subtracted during result calculation 13 LINEAR CORRELATION enables to introduce a Slope and Intercept to corr
91. s 2 11 User Personalized Programs F4 METHODS protected by Password HumaStar 300 is an open system and F4 enables the user to program an unlimited number of methods i F5 PROFILES unlimited number of user programmable profiles and organ panels FS for easy patient entry F6 STANDARDS unlimited number of user programmable Standards Calibrators F6 and Calibration Curves 4 F7 CONTROL unlimited number of user programmable Controls for an On Line F7 Quality Control program with graphic presentation of data F8 MAINTENANCE enables to check every movable and operating part in the s FS system The program is divided into three parts S Reagent System S Sampling System S Reaction Measurement System Click on its corresponding ICON In the next Chapters there will be a more detailed description 26 Human HumaStar 300 User Manual Eh Es F9 OPTIONS there are Options that enable the User to activate or deactivate if needed Upon request the following Options can be built into the system 1 Bar Code Reader for samples and Reagents 2 12 Important functions 1 User programmable calculated methods Ratio tests 2 Possibility to display calibration curves and Quality Control Curves 3 User programmable graphic print of Patient Report 4 Communication with Host computer in real time 5 Re calculation of data of an entire test 6 Statistics on performed tests 7 Automatic pre dilution
92. scribed above Also make sure to identify a given multi standard or calibrator with a Lot number or some identification that is common to all the different concentrations for a particular calibration curve To exit click on the book cover The programmed Standards are automatically saved For Detailed Information see Chapter 3 5 Human PA T Diagnostics Worldwide 93 F7 CONTROLS Click with the mouse on Controls or press key F7 and automatically the Diary Book will open to programmed Controls To Program a new Control click Edit and again Insert Page to open a window and to introduce the name of the new Control A new page will be opened for that Control Click on the first line with the asterisk to open the opposite page which displays all the available programmed methods Click on a check box of the desired method once highlighted click again on the line below indicated as MEAN Introduce on that line the Mean value for that method including its plus and minus value found on the data sheet for that control Program one by one all the methods that are part of that Control To Delete or Change a Control Value simply highlight the Control and press key Delete A confirmation window will open press Yes or No accordingly To Delete the Page or the Control completely click on Edit and choose Delete Page A window will open for confirmation click Yes or No accordingly To change a value for a Contr
93. ss OK tc confirm and start operation Coml 4 2 1 2 A window will open to START operation Start the daily run on the Sample Rack indicated with the Check Box Ifa Sample Pre dilution is necessary it will be indicated in the box Pred Ratio Note If there are methods in the daily Worklist that require Sample Pre dilution introduce the Pre dilution Ratio before START of the analyzer Only one Sample pre dilution ratio is possible per run The analyzer will perform the tests on both the diluted and the non diluted samples Br Insert initial and final positions to use prepper KH select predilution ratio and then press OK Cancel From position 1 40 tT Topostion 1 4 fF Predil Ratio 12 sl Samples Ring internal y 4 2 1 3 Human z ze Diagnostics Worldwide 49 4 2 2 Prepper the Auto Pre dilution system The Sample pre dilution has to be made before starting the daily run From the Main Menu go to Tools and click on Prepper A window will open that enables to program the pre dilution ratio as well as the positions of the samples a Samples in the Internal empty pre dilution cup in the external row b Samples in the External empty pre dilutions cups in internal row c Inserta full bottle with pre dilution liquid into its place and click OK Follow instructions they are self explanatory 4 3 Calibration Once the reagents and their volumes have been checked the next step is Fil
94. st per hour independent of method used plus 180 electrolytes at the same time by a built in ISE module for Na K and Cl Optional SAMPLE CAPACITY The analyzer is conceived to process up to 240 Patients at a time with automatic loading and programming while the analyzer is in operation 40 On Line primary tubes or small sample cups on 4 independent sector plus 20 positions for Standards Calibrators Controls and Stats Each sample has a corresponding place for a cup for automatic pre dilution if necessary REAGENT CAPACITY 30 On Line reagents each reagent can be cooled or left at room temperature METHODS an unlimited number of user programmable methods can be programmed with a single or two reagents Up to 30 different single reagent methods or 15 two reagent methods can be processed at a time or a combination of the two REAGENT VOLUME is automatically monitored with an On Line inventory The number of tests available in each reagent bottle is displayed and its stability checked A missing reagent is automatically flagged AUTOMATIC SAMPLE PRE DILUTION on request prior to start operation SAMPLING PROBE with its built in mixer and liquid level sensor transfers both reagent and sample and automatically mixes to start reaction BAR CODE READER to identify for samples and reagents Optional WALK AWAY OPERATION Once the patients are programmed all operations are fully automatic including automatic wash of the reactio
95. sult RPL Should the new Calibration not be acceptable and it is not repeated for calculation of that method will be used the previously memorized result 4 3 8 To Repeat a Standard or Calibrator To repeat a STD or Calibrator it has to be reprogrammed Go back to the Calibration Page and check the box V of the one to be repeated All the other standards etc should be deactivated Press START to repeat calibration 4 3 9 To Repeat a Serum Control To repeat a Control for one or more methods simply deactivate their check boxes by removing the V on the right and then reactivate Deactivate all the ones on the left that do not need repetition Click START to repeat 4 3 10 To Display the graph of a Calibration or a Kinetic Control Go to Reagents on Line Page and click twice on any one of the Calibrated methods its corresponding graph will be displayed Human PA o Diagnostics Worldwide 51 Eds Edt Gaph Nangaton 2 Y 28 65 22202 FM xl 4 3 10 1 a The graphs remain in memory until a new Calibration for that method is done or that calibration has been cancelled The values of the individual measurement points can be displayed by clicking on their arrows on the right b Note If the O D values of a Calibration curve are available the curve can be displayed in all 3 algorithms as Multi Standard Log Logit or Cubic c Itis also possible to view and display the graph of a Patient result Click twice on a Patient Resul
96. t then it must be a valid code 2 Can be empty only if the P ID field id not empty 68 Human HumaStar 300 User Manual Example R 240138 R 123 Jimmy Denver 77 1 Private Patient O AST 2 77 U L 0 35 200501201512 18DC R 123 Jimmy Denver 77 1 Private Patient O GLUC 2 145 mg dl 65 105 200501201512 1A77 R 123 Jimmy Denver 77 1 Private Patient O CREAT 2 3 001 mg dl 8 1 4 200501201512 1BOB R 123 Jimmy Denver 77 1 Private Patient 0 BilBic 2 2 1 mg dl O 1 2 200501201512 1B28 R 1234 Frank Rossi 18 1 Epat O BilBic 2 1 6 mg dl O 1 2 200501201512 16DB R 1234 Frank Rossi 18 1 Epat O AST 2 36 U L 0 35 200501201512 1486 R 1234 Frank Rossi 18 1 Epat 0 GLUC 0 102 mg dl 65 105 200501201512 161D R 1234 Frank Rossi 18 1 Epat O CREAT 2 1 917 mg dl 8 1 4 200501201512 16C8 R 12345 Elisa Ribas 34 0 O CREAT 2 1 879 mg dl 7 1 2 200501201512 1523 R 12345 Elisa Ribas 34 0 O BilBic 2 1 59 mg dl 0 1 2 200501201512 156A R 12345 Elisa Ribas 34 0 O AST O 34 U L 0 R 12345 Elisa Ribas 34 0 O GLUC 2 105 mg dl 65 105 200501201512 1479 R 123456 Walter Giotto 88 1 R 123456 Walter Giotto 88 1 R 123456 Walter Giotto 88 1 R 123456 Walter Giotto 88 1 R 1234567 Coppi Sandra 33 0 R 1234567 Coppi Sandra 33 0 R 1234567 Coppi Sandra 33 0 R 1234567 Coppi Sandra 33 0 Cardio O AST O Cardio O CREAT Private Patient Private Patient Private Patient Private Patient 35 200501201512
97. t and its graph will be displayed Individual Patient graphs are not memorized when their results are saved in the archive 52 Human HumaStar 300 User Manual 44 Patient Entry Patient Entry can be done at any time while the analyzer is working or calibrating Patient Entry can also be done via RS 232 serial port interface or by a previously prepared diskette It can be done using a Bar Code Pen to identify the sample or simply type in all the Patient data on the keyboard Up to 240 Patients can be programmed at a time with a maximum of 30 different methods De Edt Boh Navigation 2 Sample Data Sanpe ID 4455 Type pe Note LastName Carl 4455 s p j FutName Smith Comments Pivate Sext ge Male Tye b Tine Scrum Pls ICH 4 K J CKNAC Na v ALB GL Y iv ALK v vi 15 40 45 PM Auo Check OK 4 4 1 Click on F2 to open the BOOK Click on page 4 1 10 Samples or Patient Entry Each page contains 10 Patients corresponding to one Rack in the Sample Compartment The number on the page corresponds to the number on the Sample tray Patients can be programmed one by one by Profiles or Organ Panels or in a Batch mode Program the desired Test or Tests and click Edit and then Save for indicating the number of Patients in that Batch To program a Patient see figure Click on the first line or any line on the right to open the left side page The display is self explanatory 1 Introduce the Patient demographics starting wit
98. the STAT check box is activated together with all the other sample Racks that are still to be processed Click OK to START the analyzer The Stat samples are the first ones to be processed followed automatically by all the remaining programmed samples For details see Chapter 4 5 F3 ARCHIVE Click on F3 to open the BOOK on ARCHIVE which offers a number of important functions 1 Internal Archive stores all Patient data on the built7in hard disk The data can be viewed printed transferred or saved for future reference 2 Archive on a Diskette enables to find Patient data from a monthly diskette Human PA Diagnostics Worldwide 89 3 Test Statistics on the work performed Highlight a batch of results to obtain automatically the calculation of Mean Standard Deviation and CV 4 Test Counter displays the number and the type of tests performed 5 Last Warning displays all the warnings and or errors encountered in the past 90 days of analyzer operation The Patient Archive is stored in an alphabetical order by date or D number A Patient data can be found by its Patiente ID Patient s Last name Patient s First name Date of testing Make sure to SAVE all the daily work load before turning OFF the analyzer or prior to start a new workload To save Patient data click on OPERATION F2 and enter the Patient data page Click on EDIT to open the menu that enables to Save t
99. the Urine samples are always run separately before the routine 5 3 6 Trouble Shooting the ISE Module In case of difficulty in calibration go to F8 MAINTENANCE From there it is possible to clean and wash properly the electrodes Proceed as follows 1 Open the Sampling System page 2 Activate ISE Clean and click START Repeat this operation at least twice 3 Activate ISE Purge and click START Repeat this operation at least twice 4 Activate Calibrate and click START This operation might be necessary if the Module has not been used for a while or when the electrodes are close to expiration Sample Tube Sample Detector Optically Detects Air Bubble in Flow Sample Na Electrode Signal to Microprocessor pong noir a measures Na Potential mv Microprocessor measures K Potential mV K Electrode Microprocessor measures Ci Electrode gt Cr Potential mV Fiow ihru dans Reference Electrode Body Assam by AgCI Coated Silver Pin High Concentration KCI Sample Detector Optically Signal to Microprocessor Detects Air Bubble in Flow Pump Tube Low Resistance Ceramic Plug lonic Contact thru High Concentration KGI Internal Filling Solution d To P 2 Membrane 5 3 6 1 Electrode Measurement Diagram For one year operation with HumaStar 300 The following is a spare part list recommended for one year operation With the built in ISE Module 64 Human Hum
100. times and try again It is suggested that after every 50 samples the module should be CLEAN ed and PURGE See details in Analyzer Maintenance 4 3 5 Reag BIAS Subt If requested it should be programmed in Position O and the corresponding methods on the left should have their check boxes with V The Bias value will be used in calculation and will compensate all samples Standards and Controls accordingly Make sure that it has been programmed as YES in the Method 4 3 6 Start Calibration Once all the Standards and the Serum Controls have been programmed click the GREEN triangle START A confirmation window will open press OK to Start Calibration 4 3 7 Check Calibration After the calibration is done and printed Check carefully every value and make sure that all the results are within the limits of the programmed controls There is an automatic check done by the analyzer against the previous Calibration If the new result varies more then 10 from the previous Calibration the result will be automatically flagged as HIGH or LOW When in doubt repeat a standard or control accordingly The Controls will be used for the monthly Quality Control Program The Standardization of a method can be made on a single Standard or that standard in triplicate from the same cup A Mean will be calculated and used for calculation A minimum of 2 results have to be within 3 otherwise it will be repeated When printed there will be a Warning against that re
101. tion 2 Make sure that in the Method has been entered the Identification Code for each reagent 3 Should the Code not be programmed it will not be identified even though the bottle has a correct label Proceed to assign manually the position 4 Open the Reagent Tray and insert the bottle The Reagents positions are automatically identified 5 All information regarding the Reagents is displayed on Reagents On Line page 6 Ifthe Code is not legible it will not be accepted To use that Reagent it must be reprogrammed in the Method 7 If the Code on the Reagent Bottle does not correspond to the one programmed in the Method the following Warning will be displayed Error in Reagent Bar Code impossible to identify the following Reagents Example GLU CRE etc The Reagent position will be deactivated and it will be necessary to reprogram its position and recheck again Human AI o Diagnostics Worldwide 61 5 3 Ise Module HumaStar 300 can be supplied with a built in ISE Module for the determination of Sodium Na Potassium K and Chloride Cl in serum plasma and Urine The ISE Module is calibrated daily together with all the other methods It requires only a single reagent that is Calibrator A The samples to be analyzed are automatically transferred directly into the Module by the Sampling Arm After each determination there is an automatic wash with Cal A reagent to eliminate contamination
102. ubated in a water bath at 37 C 0 2 C The temperature in the bath is maintained constant by a thermostat that continuously circulates the water by means of the pump P6 The measurement of the reaction is made directly inside the cuvettes through two quartz windows mounted on the circumference of the Incubation chamber that enables the photometric light to go though to a detector a OL E TETAS 1 5 2 1 Analytical Plate e OUT 1 5 2 2 Incubation Chamber 8 Human HumaStar 300 User Manual 1 5 3 Cuvette Washing System It is of utmost importance that each cuvette is properly washed and dried to assure reliable results since both the reaction and the measurement take place inside that cuvette To assure perfect cleaning the cuvette has a circular design with a spherical closure at the bottom to avoid right angles which are the difficult ones to clean 1 5 4 Cuvette Washing Probe It s a four way system the first one empties the cuvette the second purges with wash solution several times and the third to blows air to eliminate any residue from the inside wall of the cuvette The Probe as it goes down into the cuvette activates the aspirating pump P3 and P8 while wash solution is forced inside the cuvette several times and re aspirated Finally forced air is blown into the cuvette to eliminate the residues of the wash solution CUVETTE WASHING STATION 1 5 4 1 Cuvette Washing System Human z ze Diagnostics W
103. ubstituted with an OK Lock well the screws 3 or 4 If necessary the operation can be repeated without the dispensing of fresh dist Water Check the value of all 8 filters they all should be between 40 and 90 Remount the back panel ADJ Horizz Vertic 6 7 1 1 Human P Diagnostics Worldwide 75 6 7 2 Drain and Fill the Incubation bath see 6 7 2 1 To be done with Analyzer ON Drain 1 Make sure that the Waste Tubing is inside the WASTE container 2 Go to Maintenance F8 Analytical System select Drain bath 3 Click START This operation takes about 3 minutes and will be over when the START triangle will be green again To Fill 1 Make sure the container is full with bi distilled water 2 Select Fill bath 3 Click START The operation takes about 3 minutes and will be over when the START triangle will be green again 4 Incase there is not enough bi dist Water there will be a Warning on the monitor Add bi dist Water into the container and repeat points 2 and 3 above Se IN ouT OVERFLOW 6 7 2 1 Note During bath filling the pump will be noisy The noise will stop the minute the pump will be full with liquid again 6 7 3 Check Incubation Temperature Operation to be done with Analyzer ON The incubation temperature is set to 37 C with the reaction cuvettes filled with 500 ul of dist Water The temperature is continuously checked during operation T
104. vette 2 Within 9 to 40 seconds Read Reagent cuvette Blank Mi 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 variable See Incubation Table 5 Measure final reaction of sample M2 Incubation of reactiion can be anywhere from 36 to 322 seconds at intervals of 26 seconds Set incubation as necessary for the method from the incubation Table 1 CALCULATION OF RESULT M2 M1 x FACTOR END POINT 2 reagents 1 2 3 5 7 Ex 5 as E o D bo v O E Kor eg s EE 3 30 2 X 3e E S 9 40 seconds 10 36 62 88 114 140 166 192 218 244 270 296 322 Reagent preheating to 37 C About 90 Max Incubation 322 seconds first turn plate gt SD Inc 1 62 Incubation 2 260 4 6 1 Add reagent into cuvette 2 Within 9 to 40 seconds Read Reagent cuvette Blank M1 3 ADD SAMPLE to preheated reagent and mix 4 Incubation Time 1 variable See Incubation Table Example 62 sec 5 Add REAGENT 2 example after 62 sec 6 Incubation 2 variable Example 260 sec 7 Measure final reaction M2 CALCULATION OF RESULT M2 M1 X FACTOR Human T Diagnostics Worldwide 99 FIXED TIME TEST Single reagent Read Reagent Add Reagent cuvette blank RB M1 Add Sample 9 40 seconds eagent preheating to 37 C About 90 Max Incubation 322 seconds
105. with a start and end character Each field should be separated by a cod ascii124 cod hex7C 1AF2 Checksum hex CR Carriage Return cod ascii13 cod hex0D Human I A Diagnostics Worldwide 67 5 4 5 Transfer Results Transmission to HOST or Diskette The HeadChar is R and the DataRecord are formatted from the Table below Transfer to Host DataRecord Parameters Accepted Values Length PID 1 Empty Alphanumeric 13 chars Fam Name 2 Empty Alphanumeric 16 chars Name Empty Alphanumeric 12 chars Age Empty Alphanumeric 2 digits Sex O Female 1 digit 1 Male Accept Time HHMM format 4 Comments Empty Alphanumeric 22 charat Test Type O Serum Plasma 1 digit 1 Urine 2 FCS Test Name Alphanumeric 6 chars Type of Result 1 To repeat 2 digits 0 OK 1 Result below normal range 2 Result above normal range 3 Optical Density out of range 4 Reagent Blank out of range 5 Substrate depletion 6 Kinetic measurement not linear 7 Standard not available 8 Error in test Log Logit 9 Negative Result 10 Result above Linearity Limit 11 Missing reagent 12 Missing Sample 13 Error in the ISE module Result Use dot as decimal separator Units of Measurement Alphanumeric Min Normal Range Max Normal Range Date of testing Format Date YYYYMMDDHHMM 1 Can be empty only if Fam Name field is not empty but if data must be stored in Pending Lis
106. y by an alternative system method or different reagent If substrates recommend to re standardize analyzer using fresh primary standards or calibrators Dirty solution in the incubation bath change Make sure that the incubation bath is at 37 C Make sure the factors used are correct Make sure that the values of expected range are for the method used on this analyzer Syringe leaks Check piston Check the O ring Check the OUT tubing for blockage Make sure the Probe is not blocked Change Syringe and piston Air bubbles inside the syringe Make sure the piston is tight and there are no leaks Make sure that the wash solution is correctly prepared and has Tween 20 in it one drop per liter of dist Water Make sure that the INLET connection into the syringe is tight or its tubing torn Samples are being contaminated Reagent and or Sample Probe is badly connected or leaking Missing wash solution or old dirty or contaminated wash solution prepare fresh Dirty cuvettes wash them first with a detergent and then with the wash solution Cuvettes are not being washed properly check the washing station Make sure that the air pump operates correctly Make sure that the washing probes do not leak Make sure the washing probes go down properly all the way to the bottom of the cuvettes during wash Make sure that the waste is properly eliminated The sampl
107. zer check ON OFF switch Make sure it is set ON LINE Make sure check box in Options is enabled for Print ON LINE Check printer cable Make sure that the check box in Options is Disabled to print On Line make sure it is connected to the analyzer make sure the printer is On Line Check wash container it may be empty Leak or torn tubing check change tubing if necessary Leaking syringe check and change piston if necessary Go to Maintenance and activate check box Fill Hydraulics and or Wash Probes and click START Make sure that all tubing is full of wash solution and there are no air bubbles in the system check proper operation of the peristaltic pumps Torn tubing replace Check connections to the Probe Leaking Syringe replace Torn tubing in peristaltic pump change Check O ring in syringe Check if photometer lamp is ON Try to read on another wavelength Check if filter drum moves Check if water was dispensed to read WATER BLANK Try to lubricate the screw with very thin oil Clean syringe with a good laboratory detergent Change the whole syringe Check with Test Diluter in F8 Maintenance Squeezed or torn syringe tubing Loose or badly connected Probe Blocked probe clean Wash solution container empty check Make sure there is Wash Solution in the container Check for leaking piston or blocked tubing Remove syringe and clean Dirty or old wash solution used for Blank c

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