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INDEX - BT2000 PLUS (Operator Manual)

1. eeessseeeseseeeeeeee nenne nnne nnne nnn 3 characters gt Send end transmission character EOT gt Wait for response from the analyzer 2 characters If the communication is successful then the analyzer responds with character Y followed by a byte which identifies the position where patient has been inserted In case the communication was unsuccessful then the analyzer responds with N followed by a byte identifying the type of error The possible errors generated by the analyzer in response to the invalid insertion of patient are as follows 0x01 oe Check Sum Error 0x02 a hee Unknown Command OXO osos Routine STAT field Error 0x04 sss oerum Urine field Error 0x05 Clone Yes No field Error 0x06 sn Cup position Error OXO7 noises Number of Analysis field Error Section Chapter 4 Serial Communication BT2000PL 0 Soft Ver S Page 2 of 16 0 08 Wrong Number of Test ces nee Position already in execution 0 0 Cloning impossible 0 0 Code duplicated 0 0 more analysis not present in the analyzer 0 0 more analysis not present in the current plate 0 0 Too many analysis for the patient For example to send a patient with code 000000000000001 serum type and w
2. Version 1 0 4 1 14 15 To run a query it is possible to specify various parameters Fig 23 such as Tests date range Analysis code range Name Surname Arrangement by code surname test date All available fields are selected by default so that all data contained in the archive is displayed By right clicking on Print it is possible to obtain a complete printout of all the reports or one compressed report By right clicking over one record it is possible to choose among the following functions View Analyses can be activated also by double clicking View Analyses displays information related to the selected record see the data display of the selected record Info Record displays the position of the selected record in the Gluick Print query result Quick print prints immediately the patient s report Into Record select date Clicking on the icon next to the editing window March poos s o Choose Date for selection of tests date it is possible to select the desired date range for search query It is possible to select the initial and final date with simple clicks oe inthe window shown at the left Click on exit to save and close the frame Press ESC to abort Sun Mon Tue Wed Thu Fri Sat USE NS 1 Figure 24 Section I Chapter F Qualit
3. From To fi 50 m 05 or or or or 10 nr 12 NEM MEM EN DN EM MEE Select DEM I C 49 50 Deselect Figure 10 Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 6 Page 10 of 17 1 5 WORK LISTS Control Standard New Entry Ox xtra Patients Routine jo im IS E STA E a s te AUTOBATCHOOS3 AUTOBATCHOO4 FE 3 13 15 17 13 23 25 i27 24 33 35 37 33 Figure 11 The Work Lists can be accessed through the menu Patients Insert Routine STAT or directly using its proper icon The screen displays the Current Tray Routine in the center and the Extra Patients Routine on the right During the working phase the Re run is also shown Click on the Routine STAT Control and Standard buttons to view the corresponding work lists For Control and STAT as for the patients the screen displays the Current Tray Routine list Re run list and the Extra Patients Routine list It is possible to run controls and calibrators even during the determination of patients The New Entry command available only for Routine STAT and Control allows programming and running new acquisitions refer to paragraph 1 4 The lists show the positions number and test codes Samples in ex
4. Dimension Sample Code This field is used to define the number of characters dedicated to the patient code If set to zero the code length is variable codes with a number of characters between 1 and 13 are accepted automatically If as an example 10 is entered then the patient code must have ten characters Use a digit for Serum Urine If enabled it is possible to use one character to automatically identify the type of sample Serum Urine undergoing test Use one or two digits for profile number When enabled it is possible to use one or two characters to identify automatically the profile number assigned during profiles programming refer to Chapter C paragraph 1 6 Creating Profiles Serial Enables RS232 serial Language System Printer Header Footer Bar Code Serial working Temperature Samples Tray Passwords port to communicate with host Present Parameters E ES computer Figure 11 Check dS e Present to enable or Not Present to disable Once the ee serial port is enabled the Hardware x cia Parameters functions with the C Variable LT Qov fields COM Number Baud Rate and Hand Shake are enabled too D Qc COM Number Sets the serial Figure 11 port number for example COM 1 COM 2 etc Baud Rate Sets data transmission speed between the analyzer the host comp
5. s a i i qm qm a a ES k LL 8 LL 3 E N c 2 3 m c 22 B 2 0 0 M A Br Bin Pi c S Pin im PB OS Eu ODEs 0 B 2 8 2 B Bo T Bo S ea 5 ea 5 E gt aN gt SoO8 C E E gt E E gt sS 5 S 0 5 D 2 5 gt a o0 5 E Ex B Bs C 56 212 mg 1 gt e cIL m gt c B n mm D a g g i g _ D T 5 i c D O cc D Ppa dad 5 i c Be o E B8 4 E mmm D Lu e z9 35 T e z9 EG e G Qe Chapter F Quality Controls Section I By clicking on Stat Histogram button the histogram for the selected data with respect to the mean value is displayed Fig 20 By double clicking the mouse on a given plotted point information about its coordinates position and value is shown Fig 16 Inserting external analyses Add New Analysis Analysis Name Analytical method Result Date 05 02 2002 F g ure 2 1 Group Test Type Female Serum Accept E xit It is possible to store in the analyzers memory results of other analyses not performed by the analyzer These data will be saved into the archive and it will be possible to d
6. Figure 30 The function Create Modify current reagents tray creates the list for the reagents placed on the tray It can be accessed from the main menu Tests main menu or from the specific icon that allows direct access Save Memorizes data Exit To leave exit the program Print To print data The window Fig 30 displays the All tests list Available and adjacent to it In Tray the tests for the current tray are listed To create the reagents tray list select one or more tests from the left window then transfer them with arrow commands gt move single test or gt gt move multiple tests To remove from the current tray list select and transfer codes with commands lt single o lt lt multiple Once tests are transferred the analyzer automatically assigns the positions and the type of bottles but the user can modify both according to his needs To modify select the desired test in Reagents positions and then move the cursor in Position textbox Now enter directly the number or use up down arrow keys to scroll Bottle size can be selected by checking Big or Little There is also a field for selecting the volume of available bottles In case of Double Reagents or Concentrated to be diluted with solution positions and bottles type are displayed for each product It is possible to use the same reagent positions fo
7. MEN Li 4 9 wo m i T wu Lg c 5 ul 2 a 0 Bw Bw E 2 E S ra ee gt m C as 5 33 BE n cee 2 n g am 1 Ew a 2000 Exit Quality Controls Chapter F Figure 17 By clicking on Trender button data sequence is displayed together with its related minimum square line Fig 17 in the lower part of the graph the equation for the line is shown By Section I double clicking the mouse on a given plotted point position and value is shown Fig 16 L Jennings Graph Figure 19 Figure 20 Rev 0 Soft Ver 6 Page 12 of 20 BT2000 PL By clicking on L Jennings button L Jennings graph is displayed for the selected data By double clicking the mouse on a given plotted point information about its coordinates By double clicking the mouse on a given plotted point information about its coordinates By clicking on Histogram button the histogram for the selected data is displayed Fig 19 i JE 4 in 3 E 5 i i o x D a gt i a qui om SE o o w 9 D E gt 5 2 ea S 2 pa a T 51 2 2 X 0 x i EUN 5 ST rj Tos al 7 w fF ol 2 i iz _ z
8. gt 55 5 UI dl 2 05 32 0 59 0 BID lt Jundrassik gt 96 1 UI dl 1 06 51 0 108 11 1 lt gt m 5 ug L 8 00 e 155 PRY lt Trinder gt 6 mg dl 2 41 0 47 5 EE Print Sort Adjust 5 Archive Data Delete results Exit Section Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 12 of 16 The Patients data display page is shown in Figure 14 It can be accessed through the specific icon shown on the right When no data is present this page is empty It is a brief representation of data and allows visualization of results of patient in execution as the tasks for the single patients are completed Once the results are archived the information present in this page will no longer be available Test results with flags are highlighted in red The following information is displayed for each sample a Sample Position XX Progressive number from 01 to 52 for Routine and STAT Progressive number from 01 to 26 for STD and CTRL b Sample Code For Patients Routine and STAT it is assigned at check in For STD and Batch it is automatically assigned It is automatically assigned for CTRL but can be assigned by the user during input The relevant group level is also indicated see Chapter F paragraph 1 Quality Controls c Surname Name Patient s personal data d Sample Type The relationship of Sample to one of the groups Routine
9. PROCEDURE The system can be accessed only if a correct sequence of USER NAME PASSWORD is entered The sequence comprises the initial access level The password Administrator is the unique person who can provide the user with system access by creating the user name access level 3 and the initial password opening The access level 3 is the initial password opening The single password sequences except for the Administrator will expire every three months and will make the password modification necessary The user with previous password will make all the necessary password modifications The manufacturer will supply with the installed software only the factory default password for the administrator as follows User Name ADMIN Password ADMINISTRATOR When accessing for the first time the Administrator will be asked to change the factory default password ADMINISTRATOR Afterwards he can set the passwords for the various users NOTE The Biotecnica Instruments S p A is responsible for the password application If necessary one can request the current software version with different procedures from the ones outlined here Any eventual request must be drawn up freeing manufacturer of any responsibility Refer to the following pages for detailed description Refer to the following illustrated text for detailed description Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 6 Page 15 of 17 The user must
10. gt Figure 27 In addition to the list of Analysis of selected code the following informations are displayed name surname test date group measurement unit flags an asterix identifies tests with flags see flag page below Min Max range and notes There is a possibility to change the analysis results by right clicking with mouse on the relative line and selecting the option Modify Value It is also possible to view the analysis flag by selecting the option View Flags or by double clicking with mouse on the desired analysis line Using the keys Previous amp Next one can scroll through the entire list of previously selected codes with corresponding analysis results Section I Chapter F Quality Controls BT2000 PL Rev 0 Soft Ver 8 Page 16 of 20 View Flags This option is accessed through the page displaying the analysis results of a particular code View Analyses Fig 27 Here it is possible to view the analysis flags by double clicking with mouse or by right clicking with mouse on the desired analysis code Any problem that occurred during sampling is shown here highlighted in red Flag Window Result LI rit Min Value Value 37 38 mg dl 55 00 120 5 No Serum Value below the Standardiz Curve after Repetition No Reagent Parameters Error Reagent Out of Limit Serum Interference Hyperactive Sample Test Limit Unstable Serum Hyperactive Sample Max Abs Limit Inverted Reaction
11. Hyperactive Sample Max Abs Delta No Reference Solution 0 Pathological Sample below 9 Pathological 5 ample above M aximum Bubbles in ISE Module Value above the Standardization Curve Related Analysis Calculation Impossible Value below the Standardization Curve Eror in calculating Related Analysis Value above the Standardiz Curve after Repetition Impossible to perform nat in the tray Possible Prozone Figure 28 The Flag Window Figure 28 displays a brief description of the flags the results unit of measurement and the acceptability range Min Value amp Max Value Modify Analysis Value Old Value AY Mew Value E E Accent amp Cance Figure 29 Modify Analysis Value It is possible to modify the selected analysis Fig 29 result by right clicking with mouse in the Info Record page In the first field the Old Value of the result is shown while in the second field New Value it is possible to insert the modified result In case a wrong value is entered then a screen message will alert the user to repeat the operation Please pay careful attention to the correct entry of the decimal separator In the patient s report page there are also the following options amp Previous Next E il Send to RS232 when enabled sends results to the host computer Print preview displays the printing preview for the patient see also Fig 32 Previous
12. PRV lt Color gt 82 4 umg Adl i 5 02 49 0 115 VED lt Trinder gt 92 9 ug Adl i 7 04 54 0 98 0 FAC lt Color gt 4 67 ng L i 4 57 20 0 76 0 51 000653 Rossi Matteo STAT BID lt Jundrassik gt 41 0 mg dl i 0 900 42 0 99 0 t gt H3 00084117 Barnard Fabio Routine Glicemia CNN 55 5 UI dl i 2 05 32 0 59 0 BID lt Jundrassik gt 96 1 UI dl i 1 06 51 0 108 Lipasi CNN 15 5 ng L i 8 00 42 0 122 PRV lt Trinder gt 30 6 ug Adl i 2 41 13 0 47 5 Figure 1 The Patient s data display page is shown in Figure 1 It be accessed through the specific icon shown on the right When no data is present this page is empty It is a brief representation of data and allows visualization of results of patient in execution as the tasks for the single patients are completed Once the results are archived the information present in this page will no longer be available Test results with flags are highlighted in red The following information is displayed for each sample a Sample Position XX Progressive number from 01 to 52 for Routine and STAT Progressive number from 01 to 26 for STD and CTRL Section I Chapter G Displaying and Printing Results BT2000 PL Rev 0 Soft Ver S Page 2 of 7 b Sample Code For Patients Routine and STAT it is assigned at check in For STD and Batch it is automatically assigned It is automatically assigned for CTRL but can be assigned by the u
13. Samples and through barcode scanning using the Profile utility refer to Chapter C paragraph 1 6 Creating Profiles Bear in mind that when analyses programming is done manually with barcode enabled the codes and assigned analyses must be entered prior to verification of assigned positions With acquisition via host computer it is sufficient to verify positions just before test s run In case of acquisition via barcode scanning using Profile utility it is sufficient to verify positions just before running tests Section I Chapter I Barcode amp Related Functions BT2000 PL Rev 0 Soft Ver 8 Page 2 of 4 Entering patients with and without bar code on the same tray Patients with barcode and those without can be run together Patients without barcode must be inserted exactly into the positions assigned during programming Patients with bar code can be freely placed in any of the free position with no need to respect the assigned position number If the user does not respect this procedure during barcode verification the patients without barcode will be moved to the Extra List refer to Chapter E paragraph 1 5 Work Lists Afterwards these patients will be submitted for the execution of the assigned tests Additional Informations regarding types of barcodes The barcode scanner located inside the analyzer has 5 or 6 different codes stored in its flashram memory At present the following codes are default set in the flashra
14. 6 33 44 0 80 0 VED 51 0002151 63 0 mg L 6 00 26 0 72 0 9 CTRL6724 89 6 mg dl 8 96 25 0 84 5 3 0009457 98 0 mg dl 4 96 37 0 65 5 Stampa Figure 15 After the termination of programmed task the results can be viewed per Test The test Results display page is shown in Figure 15 Test results with flags are highlighted in red The following information is displayed for each single test a Sample Position XX Progressive Number from 01 to 52 for Routine and STAT b Sample code c Sample Type d Results Progressive Number from 01 to 26 for STD and CTRL For patients Routine and STAT it is assigned at input It is automatically assigned to STD and Batch It is automatically assigned to CTRLs but it can be given by the operator during input The group pertinence is indicated see Chapter F paragraph 1 Quality Controls The relationship of Sample to one of the groups Routine STAT CTRL or STD is indicated between brackets Tests results with any eventual flags The following commands are available in the results display page Print It provides hard copy of the entire contents of the data display page Exit Exits from data display page Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver Page 14 of 16 DISPLAYING REAL TIME DATA 51 0003216 RAT 41 7 UI
15. Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 18 of 22 The installation procedure automatically checks the communication port COM used for communication with the 552 In case the communication port not found cable disconnected no processor etc the following screen Select communication port will appear bt Plus Setup Do Welcome to Analyzer Installation Select comunication port Communication Port Note Com Comunication not C Com2 fouded on current analyzer L Com3 Please select the Com4 comunication port manually O Accept Pstart e E be Plus Setup Here the operator will manually select the Com port used for communication normally Com4 is utilized Select Com4 and click Accept Now the installation of operating programs begins CAUTION DO NOT INTERRUPT THE ONGOING INSTALLATION UNLESS FOR SERIOUS REASONS Setup Status bt Plus Setup is performing the requested operations Installing Copying help files D Program Files 4nalpzer Help 8T OPERATIVE nh m 2 Plus setup Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 19 of 22 After the termination of previous phase a message Setup has finished installing bt Plus on your computer will be displayed InstallShield Wizard Complete Setup has finished installing bt Plus on your computer
16. NEXT in both the screens Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 9 of 22 Now the Setup installs the Windows components and then completes the final set of tasks which may take several minutes 000 Profe ial Setup ER tela i n esas BER Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 10 of 22 The second phase of the installation has been successfully completed Remove CD from the drive Click Finish to restart the system Windows 2000 Professional Setup Completing the Windows 2000 Ti Setup Wizard You have successfully completed Windows 2000 Setup If there is a CD in your drive remove it Then to restart your computer click Finish 5 3 COMPLETING THE INSTALLATION This is the most delicate phase of the whole process If it is not performed correctly then it will be necessary to repeat the whole installation procedure of the operating system A welcome message is displayed INetwork Identification Wizard Welcome to the Network Identification Wizard This wizard helps you connect your computer 0 network To continue click Next Click NEXT key Enter user name who will log on to the system STRICTLY OBSERVE THESE INSTRUCTIONS Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 5 Page 11 of 22 Network Identification Wizard Users of This Computer
17. Next goes to the previous next patient Exit exits from the patient s report Send fep A5232 Print Preview Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 17 of 20 Printing Reports The following options are available in the main search window Patient Archives Fig 23 Search Pint al Qe Test Report from here it is possible to select one of the available tests and to print the corresponding results Fig 30 and 31 Test Report Lipasi Analyses 10 Analysis selected Fig 30 Patients Archive Analysis Values PRV Date Select All Surname Select All Date 27 02 03 27 02 03 27 02 03 28 02 03 28 02 03 28 02 03 28 02 03 03 03 03 03 03 03 03 03 03 03 03 03 03 03 03 Value 14 27 Ulidl 54 49 Ulidl 66 74 98 43 UM 52 53 mg L 3 800 mg dl 51 50 mg L 37 88 mg L 49 03 mg dl 28 77 UIA 12 19 mg dl 22 08 mg dl Code Select All Name Select All Code Group 0002222 Male 0007502 Male 0007708 0001052 Male 0001991 Male 0009614 Male 0005706 Male 0009850 Male 0007879 Male 0008246 Male 0002360 Male 0008013 Male Fig 31 Test Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Method Trinder Jundrassik Jundrassik Color XXX Jundrassik Color Trinder Trinder Trinder Color Sele
18. e Results Section I Chapter G Progressive Number from 01 to 52 for Routine and STAT Progressive Number from 01 to 26 for STD and CTRL For patients Routine and STAT it is assigned at input It is automatically assigned to STD and Batch It is automatically assigned to CTRLs but the operator can give it during input The group pertinence is indicated see Chapter F paragraph 1 Quality Controls Patient s personal data The relationship of Sample to one of the groups Routine STAT CTRL or STD is indicated between brackets Tests results for a given patient are displayed indicating extended name of the analysis test methodology normal values range and any eventual warning flags see paragraph 1 5 Flags List For automatic repetitions the values for the first and second determination are shown Tests results with any eventual warning flags Displaying and Printing Results BT2000 PL Rev 0 Soft Ver 6 Page 5 of 7 The following commands are available in the Real Time data display page Print It provides hard copy of the entire contents of the Real Time data display page Exit Exits from Real Time data display page 1 4 REACTION GRAPHS This function can be accessed through a specific icon It is used for displaying and eventually printing the graphs of the analyses The analyzer proposes two graphic display options All Patients or Single Patient By default the f
19. 1 p MUSE NOW on L I gt gt m system 1 to select EN K 11 a f elect ROW key below s and DOWN AR NTER h list n press E LT you want amp ad ESC DI PES Press ENTER to continue Now the Setup formats the hard disk and this phase may last for a few minutes ormatted CUn ee Lu EA RTI eue Vx ELE 37 5 02 SUB WC jys y 3 EE h 4 H E P I t Rev 0 Soft Ver 8 Page 4 of 22 BT2000 PL Software Installation amp Upgrade Section Chapter 5 Now the Setup copies files to the Windows 2000 installation folders in the hard disk and this may take several minutes to complete t L 1 gt e L u p C D 1 S 1 4 S b 0 n os A installation folders 1 7 1 m 1115 may take seueral minutes to complete IN 4 221 1 VALE While y y 1 MP CE C et pete en CR 19 Setup b pying fils o oes pet pr t wu a 3 i At the end of preceding phase the system will restart DO NOT REMOVE CD ROM FROM CD ROM DRIVE i LL 119090 Q wt your computer press ENTER your computer restarts Setup will continue S DIE ogc oe T2422 I COSE HS TEES E oor Your computer will reboot in 4 s ee gt Ge
20. Click Finish Now a screen with various options for End installation with restart or without restart of the system is displayed In case of the new installation select Yes want to restart my computer now first option End installation Setup has c ompleted installing bt Plus Yes want to restart my computer now Mo I will restart my computer later Click Finish to exit bt Plus etup FUIT E Plus setup QUK EN Now the operating program has been installed correctly in the ey Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 20 of 22 9 6 UPGRADING THE BT2000 PLUS SOFTWARE lf a software upgrade disk is inserted or reinstallation of BT2000 PLUS program then the following screen is displayed InstallShield Wizard Welcome Modify repair or remove the program Welcome to the bt Plus Setup Maintenance pro installation Click one of the options below gram This program lets you modify the curent Recycle Bir Select new program components to add or select currently installed components to remove C Repair 4 Reinstall all program components installed by the previous setup Internet Explorer E EM Remove a Remove all installed components Connect to the Internet InstallShield istae w E fa EMinstalishield Wizard T Select the option Remov
21. H20 total wash of cuvette 170 ml approximately Extra wash of cuvettes approx 170 ml 13 ml Cuvette Washing Solution Operating Limits The instrument cannot guarantee the preceding performance specs in the following conditions 1 Ambient conditions beyond the specified range 2 Use of non conformant clinical chemistry products such as washing solution distilled water and etc 3 Maintenance schedule and expiry date ignored 4 Use of non original spare parts and consumables The manufacturer does not guarantee the correct instrument Incase of implementation of unanticipated methodologies Consult your nearest sales service office or factory for the use of different methodologies Section I Chapter D Performance and Limits Rev 0 Soft Ver 8 BT2000PL Page 3 of 3 OPERATOR MANUAL BT 1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER E 1 OPERATING PROCEDURE 1 1 Turning on procedure 1 2 Reagents insertion and removal 1 3 Running Standard amp Controls on command or timed 1 4 Samples 1 5 Work Lists 1 6 Turning off procedure 1 7 Access Password Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Page Page Page Page Page Page Page Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Index a TS OBRNND 14 15 1 OPERATING PROCEDURE 1 1 TURNING ON PROCEDURE Turn on the analyzer by pressing on off switch on the rear panel refer to Chap
22. Lamp Setup Temperature test Figure 2 Run a dilutor prime by the command Dilutor prime Fig 2 Run a wash by the command Wash and fill up After the instrument has been turned on for 20 minutes warm up time run a photometric zeroing by the command Zeroing on water VV V Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 3 of 16 SERVICE ICONS BAR Reset Analyzer F5 Stand by Analyzer F6 1 TD Displays the Volumes Status Used to Insert Remove Reagents F10 D Password F7 e Status Analyzer F2 Printer Setup F4 Help on line F1 FUNCTION ICONS BAR 1 To Insert New Codes Parameters Standards and Controls for all Analyses 2 To Create the On Line Reagents Tray 3 To Insert Parameters Standard and Controls for the On Line Reagents 4 To Insert Modify Profiles 5 To Insert Routine View Programmed or In Run Patients 6 To Insert Batch 7 To Run Standards 8 To Run Controls 9 Analyzer s Utilities 10 Mechanical Calibrations 60000600000 11 a Results Listed per Patient b Results per test in real time Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 4 of 16 E 12 No Results 13 Reaction Graphs 14 Turning ofF the System Simply positioning the cursor the icons the so called hint will appear where available showing a
23. STAT CTRL or STD is indicated between brackets e Results Tests results for a given patient are displayed indicating extended name of the analysis test methodology normal values range and any eventual warning flags see Section I Chapter G paragraph 1 5 Flags List For automatic repetitions the values for the first and second determination are shown NOTE The information regarding calibrations such as computed factor values or any eventual errors that occurred during execution standardization are shown in the data display page The following commands are available in the data display page Print Sort Adjust Archive Data Delete results Exit E Print Print command If enabled it prints the entire contents of the data display page Sort Data sorting command This function is enabled only at the end of working session The real time data are displayed in test execution order The Sort command allows rearranging of data by test sequence order Adjust Data re reprocessing command This function is enabled only at the end of working sessions After confirming the command and selection of the desired analysis two data re processing modes are available The first mode allows a positive or negative percentage correction of increment or decreasing and the second mode uses the latest valid calibration This function is password protected see Chapter C paragraph 1 5 Archive Data This c
24. Select each analysis to be performed on the sample Profile Select the desired profile among the available The analyses programmed in this way can be modified To add or remove tests it is necessary to enter in the screen Select tests and confirm by clicking on the textboxes With Deselect it is possible to delete an already selected profile Save Saves patient s data and the associated analyses With this command test execution is delayed NOTE In the routine programming it is possible to acquire a greater number of patients than the available number of positions in samples tray All the patients acquired with no associated position are saved and displayed in the extra patients list and can be transferred to the main list on user s demand Refer to Chapter E paragraph 1 5 Work Lists Run This command immediately starts the execution of the programmed patient The sample plate adjusts itself to match the position assigned to the patient and a blinking red LED indicates the position for inserting cup or primary tube If patient code is missing or no analyses have been selected then this command cannot be activated Entering samples in Batch Fi Patients Tests Analyzer Utility External Programs 00000900 Direct access icon From To fi mo o o oc o os 1 M 12 wey Selec
25. Who can lag on to this computer HUS Cond 2g Pinta EL E compute Windows always assumes the Following user has logged on to this computer ei User name Administrator Password Confirm password EAE Es mue m 2 4 pu Ei scu te LIES Tee ADIE A PA AA e CW 29 quer gt S Enter Administrator as User Name Enter ENZO as Password which was also used in the previous installation phase Confirm password by rewriting it Click NEXT to continue The Windows installation has been completed Click Finish to exit Network Identification Wizard Completing the Network Identification Wizard You have successfully completed the Network Identification Wizard To clase this wizard click Finish Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 12 of 22 5 4 SETTINGS OF THE OPERATING SYSTEM Uncheck the box Show this screen at startup at the bottom left of the screen and click Exit at the bottom right of the screen I Getting Started Places You can access all your documents programs and settings from the start button Recycle Bin i Internet Explorer Connect to the Internet Open Control Panel Click Start point to Settings and click Control Panel My Documents LJ P 2 My Computer W
26. cuvette blank End Point Starter Dynamic As normal End Point with serum starter 1 phase Only reagent R1 or R1 R2 2 phase Serum Computation Reading 2 phase Reading 1 phase Absolute End Point This method is identical to the End Point but without subtraction of the Blank reagent COMPUTING CONCENTRATION VALUE n r e If the External Dilution Factor is less than or equal to 1 then Fnr 1 e In other cases Fnr External Dilution Factor e If sample is run with dilution then Fnr External Dilution Factor Dynamic Blank Check lf Dynamic Blank is present and test is either a Kinetic or a Fixed Time then e ABS ABS Dynamic Blank Value Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver Page 6 of 31 lf Dynamic Blank is not present and test is an End Point then e ABS ABS Blank Value ABS ABS x Fnr e fthe factor is used then Conc ABS x Factor e Otherwise the concentration is extrapolated from the standard s curve where Fnr Internal Factor ABS Test ABS Conc Final concentration 1 2 2 APPLIED MATHEMATICAL FUNCTIONS Correlation Coefficient TYXL 1 XL TY 1 1 where Number of readings Number of reading i Times Readings Linear Regression Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver Page 7 of 31 where Angular coefficient for the line Final point for the line Number
27. d Cordless Keyboard amp Mouse Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter I Barcode amp Related Functions BT2000 PL Rev 0 Soft Ver 8 Index IN 1 BAR CODE AND RELATED FUNCTIONS The software for the BT2000 Plus allows independent enabling and disabling for bar code scanning on Samples and Reagents refer to Chapter H paragraph 2 Analyzer Setup The enabling of barcode scanning on serum visualizes specific commands in the program refer to Chapter E paragraph 1 5 Work Lists The BT2000 PLUS uses as format a numeric code of max 13 digits for example EAN 13 If the used format has a lesser digits then the information space is reduced in the labels printing protocol In fact it is not possible to add profiles number serum and urine identification and besides the number of available characters for patient code are also reduced Printing protocol for barcode labels for patients with EAN 13 format for Serum Urine and Profile Number EAN 13 POSITION USE NOTES 01 10 Patient s code 0000000000 9999999999 Serum or Urine S U 0 Serum 1 Urine 12 13 Profile Number 01 99 00 None PILI J Patient s Code S U Profile No 2 USING THE BAR CODE 2 1 BARCODE ON SAMPLES Entering Patients Tests to be run can be acquired from the Host Computer from those stored after manual input refer to Chapter E paragraph 1 4
28. for memorizing NOTE Confirmation is requested in all the patients work lists to perform Codes Transfer Commands The analyzer verifies the availability of positions in the samples tray list and eventually prompts the user about the impossibility to complete the task Global Insert View patients The Functions menu in the Global Insert View patients fig 12 bar provides access to the following commands Global Insert View Patients Functions all pending patients d E m Repetition for analyses STAT Deal MENT New Entry MASA i ent Trap Routine Extra Patients Rout Clear Patient List Options Figure 12 Run All Pending Patients A sole command for running the already acquired patients and the partially processed patients because of an interruption during tests execution The analyzer will continue to process suspended patients Confirmation is required Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 6 Page 13 of 17 Repetition for Analyses This command re runs test for samples First the selection of the desired analyses codes is required and then the confirmation The analyzer automatically searches for the samples which had already undergone determination of selected analytes and performs the newly assigned work list and then updates patient reports with new data obtained from the repetition RS 232 This function is used
29. icense Agreement legal between you Ceither an individual 0 n the manufacturer Manufacturer 3 Sys stem or computer system component Buc etre qu uired the Microsoft software product T TUR RE PRODUCT or P ti PRODUCT is not accomp I ot use or copy the SOFTWARE PROD LH The SOPINI PE RODUCT includes computer ut n ass Mert ted materials and ocunentation ine EULA is an stance 2 ights ONLY if the SOFTI IARE PRODUCT P 27 1 ificate of a d Dare SIE EE m ae RE vided with the Any s Ehe c SOFTWARE PRODUCT that E pH xn 2 Eno ith a sepa end us er license aareenent ou agree the terms of that license agreement You to he oe terms of this EULA by installing cessing or otherwise sing the hes lanufacturer PERES pon AAR ESC Fr aq ACE DOUN Next Page ao Press F8 I agree to accept it Windows displays the existing partition of the hard disk ANDAI i ADTAL L n mina U n S set up Windows 2000 To create a partition in the space press To delete the selected partiti SER ES PE Mee c 724 MB Disk at ldo on b di iles Press ENTER to use the default partition Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver amp Page 3 of 22 Select Format the partition using the FAT file system n r TE 01 m
30. life saving The analyzer refrigerator produces water condensation in the reagent chamber This is important for cooling the reagents in the bottles In case of too much condensation wipe it off with a clothe without drying it completely never do this operation with the analyzer on The instrument can be leveled by means of the four adjustable feet to ensure the good drainage of the condensation CAUTION The analyzer is provided with four integral push pull handgrips located on the left and right sides of the base frame To lift or move the instrument from one location to another always use the handgrips NOTE All the components shown in the following figures may undergo modifications over the time Therefore it is recommended to verify them accurately prior to any repair or installation refer to eventual specific manuals included ELECTRICAL CONNECTIONS Connect main power cable from the instrument to the UPS and connect the latter to the mains wall outlet Figure 2 Power circuit should respect current laws and have a good earth connection Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 4 of 9 UPS Figure 2 The printer and peripheral devices should be connected to the appropriate accessory power connectors on the analyzer rear panel adjacent to mains power inlet See Figure 3 2 FUSE PRINTER POWER ON OFF ANALYZER P 9 E X A a
31. notice for any reason This includes but is not limited to utilization of advance in the state of the art and changes thereof Product enhancement resulting from our continuing quality improvement effort may necessitate changes in specifications without notice This fact doesn t oblige the company to inform its actual customers because the information included in the present manual refers to state of the product when shipped thus no warranty about notification of future changes is given The information contained in this manual is proprietary with Biotecnica Instruments S p A Reproduction of any part or whole may only be performed with written permission from Biotecnica Instruments S p A Section II Chapter 2 Warranty Conditions BT2000 PL Rev 0 Soft Ver 8 Page 3 of 4 a _ _ _ Page 1 of 1 instruments Parts Instruments Return Authorization J DATE From To Technical Assistance Export Manager Client information Instrument model Serial number Defective part Part description Code Serial number Bar code number Quantity Under warranty Yes No Order number Date Description of the problem Request for Repair Exchange LJ Quotation LJ Urgent O Name oignature Biotecnica Instruments response Return authorizat
32. or XXX lt 2 can be displayed inside the code boxes fields The symbol indicates that the position is used for many analyses while the symbol XXX lt 2 indicates the position of second bottle pertaining to the double reagent analyses In the field SECTOR the belonging group is shown and the default choice is To change group click on the left and right hand buttons There are two ways to insert remove reagent bottles in the tray one can insert bottles for single analysis or for the whole sector and the same is valid for removal of bottles Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver Page 2 of 17 Single bottle Right click over analysis code A combo box asks the user to choose between Insert bottle or Remove Bottle After the choice has been Insert bottle made the analyzer will correctly position the tray to match with the Remove bottle arrow at the base of the tray itself The verification of fluid volume contained in the bottle is associated with the insertion procedure With the barcode option enabled identification is correctly achieved through the automatic scan of the barcode on the inserted bottle The same function can be performed on command by activating the Scan bottle command near the insertion and removal commands Scan bottle Whole sector Right click over the SECTOR field A combo box asks the user to choose between sector s insertion Insert sector or removal Remo
33. patients Repetition for analyses Clear Patient List Os Om I n Proqram Code 8 2 524023141223 Access level 100 MASTER No Message 9 13 2004 9 32 18 AM RT 26 C CT 37 0 C 93 mBar o D Main menu each menu generates other commands and or options amp Direct access icons selecting each icon the relative command is directly activated 4 Software version operative program version 5 Access level is the access level of the operator it is password dependent 6 Vertical Bar Commands Direct access to function commands Messages bar clicking here opens a window showing the messages received by the program Errors bar by clicking here a window is opened showing the errors occurred during the work session 9 Refrigerator Status Indicator Operating Pressure Indicator Ambient Temperature RT Cuvette Temperature CT Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 4 of 11 Phas Patients Tests Analyzer Utility External Programs Insert patients Program Code 8 2 524023141229 Access level 100 MASTER No Message Bs EET UPC 4M RT 26 C CT 37 0 C 93 mBar SERVICE ICONS BAR Reset Analyzer F5 Stand by Analyzer F6 Displays the Volumes Status Used to Insert Remove Reagents F10 Password F7 Status Analyzer F2 Printer Setup F4 Help on
34. 9 of 17 Control Standard New Entry Options nsert Routine STAT Insert Batch Run all pending patients Repetition for analyses Clear Patient List Figure 9 Insert Batch In this page Figure 10 select the desired analysis code and associate sample positions with it Analysis list and routine numerations are displayed Click on the check boxes to enable or disable a test The Select command located next to the tray positions automatically enables all the positions entered in the fields From and To and the Deselect disables them all The selection or deselection of serum plate can also be performed by indicating the first and the last position of the work list After entering one or more analysis code enable test run check and start working phase by pressing Run The enabled sera positions are highlighted in red while the analyses codes in blue Press Exit to terminate and leave This check in procedure is simplified as it doesn t require patients data entry and doesn t make any distinction between serum and urine In the report A progressive numerical identification is automatically assigned to the report for example Batch xx NOTE Even if the programming is based on analyses the analyzer processing is always patient selective Patients Tests Analyzer Utility External Programs oooeoooooooeo Insert Modify Batch entry B Exit
35. CH Repetition for analyses Selects the repetition Run all pending patients Ctr R by analyses upon operator s request Clear Patient List Deletes the entire Repetition far analyses memorized patients list The analyzer will request Clear Patient List confirmation before deleting Figure 1 Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver S8 Page 2 of 31 Tests Menu Fig 2 Tests parameters Tests It is used Tests Analyzer Utility External Programs for programming and memorizing tests Tests parameters All Tests Shift cti 4 Analyses parameters Only In Tray It E ESTE S SUY provides direct access to the analyses on the current reagents tray Create current tray shit Ctrl T Create current tray This item is used to Insert prafiles Shift ctri P Create the list of analyses in the current reagents tray seu snit cilsk insert profiles See paragraph 1 6 Export Data Creating Profiles Import Data Figure 2 Run Standards Controls Activates the procedure for running standard controls Export Data Copies onto a floppy disk or any other desired location the above mentioned parameters There are two available options Back up for exporting all the analyses and Single Test exports the single tests Import Data Copies the above mentioned parameters from a floppy disk or from any other location There are two available options Resto
36. Delete Data For Data lt All Start Date End Date 14 12 2001 14 12 2001 Exit Alt F4 for Analyses Method For Method Export Data For Lok Import Data Total Figure 9 10 Export Data saves memorized quality controls on disk by selecting a particular Method Analyses Lot and Date If All is selected in the above mentioned fields then all controls will be memorized Refer to Figure 10 Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 6 of 20 Import Data Overwrites the actual stored data with those stored on a disk CAUTION It is not possible to restore overwritten data Delete Data it is possible to delete records in the archive by Date Method Analyses Lot or erase the whole archive Figure 9 CAUTION It is not possible to restore deleted data in the previous Delete Data command Archive on floppy Displays and prints quality controls stored on a disk Functions such as Insert Modify Data Cancel Export and Import are not available Figure 11 2 Quality Controls Functions Data Preference l Archive on Floppy Figure 11 Printer Setup Select Method Group Test Type TOI 7 V Serum Version 1 58 2121 Figure 12 The Population module manages and displays graphs as well as data and computes statistics on data of all the analyses p
37. OBJECTS e g CABLES TUBING ETC CAN BE TRAPPED BY ANY MOVING OR ROTATING PARTS e g SAMPLING ARM PLATES WASHER MODULE PUMP ROLLERS ETC OF THE ANALYZER SYSTEM NOTE a b The careful observation of the proceeding warnings should result in a long and satisfactory performance If the above mentioned notices are not fully observed then any form of warranty Is no longer valid and Biotecnica Instruments S p A will not be responsible for any subsequent damage or loss see Section Il 2 Warranty Conditions The information in this manual is based upon the hardware and software currently in use Biotecnica Instruments S p A reserves the right to make software and hardware changes or improvements for product enhancement without notice and without imposing any obligation upon itself to install these changes or improvements on its products previously manufactured Section I Chapter K Warnings amp Precautions 2000 PL Rev 0 Soft Ver 5 Page 5 of 6 1 3 WASTE DISPOSAL e ensure environment health and safety it is recommended not to discard the used consumables waste liquids or disposable maintenance kits into the environment e Insure that the disposal of waste material is done according to all applicable laws and regulations 1 4 SAFE DISPOSAL OF THE UNUSABLE INSTRUMENT For the proper disposal of instrument that is obsolete outdated beyond repair or unusable follow these steps carefully 1 Remove all c
38. Power 500 Watts PFC Unit Power Factor Correction included Section I Chapter M Technical Specs 2000 PL Rev 0 Soft Ver Page 2 of 4 PRINTER POWER REQUIREMENTS Universal Input 100 240 V 50 60 Hz Power 50 Watts UPS optional Input 220 V 50 60 Hz 110 V on request Output 220 V 50 60 Hz 110 V on request Power 1100 VA 710 Waitts ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY The BT2000 PLUS instrument has passed all tests related to Electromagnetic Compatibility EMC and Safety requirements for electrical equipment for measurement control and laboratory use performed by the OCE Lab EMC amp Electrical Safety Compliance Test Laboratory Ministry of Communication Italy accredited EMC certification body No 051 of 21 October 1998 Certificate s documentation is available on request The BT2000 PLUS is in conformity with the following normative standards EN 61326 EMC EN 61010 1 ELECTRICAL SAFETY PHOTOMETER Optical System Solid state photometry patented by Biotecnica Instruments S p A Detectors 10 UV VIS photodiodes reference channel PRECISION AND ACCURACY Spectral Response 340 380 405 436 480 510 546 578 630 700 nm Bandwidth 5 max Photometric precision 1 from to 2 000 O D 2 5 at 2 400 O D Photometric Sensitivity 0 0005 ABS Drift 0 005 ABS h steady state Optical path 7mm Photometric Lamp Tungsten Halogen Lamp with Dichroic Reflecto
39. Previous Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver S8 Page 4 of 31 1 2 OPERATING PRINCIPLES Generally adding a sample to its reagent determines a chemical reaction involving enzymes and or substrates whose effect is to increase or decrease the color and thus the optical density of the solution in the cuvette As the reaction proceeds it is read by the analyzer in terms of absorbance A or Abs for absorbance As every analyte has its own reagent with its proper characteristics therefore it becomes necessary to use different methodologies preparation and reading based upon different wavelengths for each test Many tests are based on similar principles hence they will have in common the method and the wavelength but not necessarily the incubation and reading times To obtain the concentration of an analyte in a sample the analyzer multiplies the absorbance or the absorbance delta AA absorbance variation developed by that sample reaction with a multiplication factor Besides some analyses for which a theoretical factor is used usually the factor is calculated during a calibration During the calibration the analyzer reads the reaction obtained with a known concentration sample called standard The factor is calculated by dividing the known concentration value by the absorbance read for the standard For the non linear analyses e g immunoturbidimetric tests it is necessary to create an interpolation c
40. Running Tests and the Chapter E paragraph 1 5 Work Lists 1 5 RUNNING TESTS Once the data has been entered insert the samples into the tray Figure 12 and then place the tray into the analyzer Figure 13 Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 11 of 16 Options The Options menu is available in the Current Tray Routine STAT and Controls It displays the following commands Send to extra patients The selected patients are removed from current samples tray list for placement on Extra Patients List Selection can be done by checking the Send to extra patients Print appropriate boxes Select All Print Lung Prints the partial for selected items or total samples list Select All Belgie Automatically selects the whole list bb Deselect All Scan tray and run d Automatically deselects the whole list confirmation required Run Work start command If single patients or the whole list are selected a message asks if the samples have been inserted If the answer is affirmative the analyzer automatically starts processing In case of a negative answer a guided procedure will assist the user to insert the samples The selection of the sample to be inserted is performed by confirming with cursor on the check box Use Select All to select the whole list and Deselect All to deselect it bu
41. Soft Ver 6 Page 10 of 12 SCREEN MESSAGE CAUSES amp REMEDIES This message stops the execution of programmed ERROR RESETTING ARM tests The message ERROR RESETTING ARM ARM HORIZONTAL HORIZONTAL may be generated by accidental blocking of arm or by damaged arm Try to reset by pressing key F5 If the message persists then contact approved technical assistance This message stops the execution of programmed tests The message ERROR RESETTING ARM ERROR RESETTING ARM VERTICAL is generated by an error during the vertical motion of the sampling needle This error may Si be caused by a deformed needle obstructions i e improper placing of the reagent bottles or a defective position sensor If the needle is deformed replace it As regards obstructions just place the bottles correctly Afterwards press F5 Reset key to restore correct analyzer operation In case of defective position sensor contact approved technical assistance This message stops the execution of programmed tests A defective position sensor of the washer ERROR RESETTING module generates the message ERROR WASHING STATION RESETTING WASHING STATION Press F5 Reset key to restore correct analyzer operation After eliminating the causes of this message proceed with execution commands Chapter E paragraph 1 5 If the message persists contact approved technical assistance The message Impossible to reset analyzer indicates a system
42. Standards and Controls Bar code scanner 2 separate scanners for positive identification of samples amp reagents TIME REQUIRED TO REACH STEADY STATE Ambient conditions Analyzer 21 C R T 33 RH Time required for the analyzer to completely reach steady state 20 minutes Ambient conditions Refrigeration Chamber 21 C R T 33 RH Time required for the refrigerated bottles to completely reach steady state Approx 2 hours CLINICAL CHEMISTRY Sampling cycle 17 seconds Analytical throughput 210 tests hour single reagent Test execution time max 360 seconds CUVETTE OPERATING TEMPERATURE Programmable Temperatures Room Temperature 32 C and 37 C Precision 0 2 C Accuracy 0 2 C Temperature Monitoring Device based on Peltier Effect REAGENT CHAMBER TEMPERATURE Nominal Temperature 11 C Approx Temperature Monitoring Device based on Peltier Effect OPERATING AMBIENT TEMPERATURE 18 C to 32 C 10 to 90 RH Non condensating PHOTOMETER Optical System Solid state photometry patented by Biotecnica Instruments S p A Detectors 10 silicon photodiodes for UV Visible 1 reference channel PRECISION AND ACCURACY Spectral response 340 380 405 436 480 510 546 578 630 700 nm Bandwidth 5 max Photometric precision 1 from to 2 000 O D 2 5 at 2 400 O D Photometric sensitivity 0 0005 ABS Drift 0 005 ABS h steady state Light path mm Light source Photometer Reflectorize
43. The amount of light radiation that passes through a homogeneous absorbing medium is defined as transmittance T where T 1 lo ly incident light radiation intensity transmitted light radiation intensity The absorbance A or extinction E is defined as A log 1 T log Mo The Lambert Beer law states the relation between absorbance concentration of a compound absorbing light and sample thickness A ecd molar extinction coefficient of the compound absorbing light at a certain A wavelength c molar concentration of the compound absorbing light d optical path of the radiation into the solution The absorbing spectrum of a compound is represented by a graph where the absorbed light 7 absorbance is related with the wavelength For a colored solution the graph will show one or more absorbance peaks These may be in the visible part of the spectrum 400 700 nm as in the ultraviolet 200 400 nm region The BT2000 PLUS uses a photometric system specially designed by the R amp D Dept of the Biotecnica Instruments S p A A light beam is sent through a cuvette that contains the solution that has to be read The exiting light beam is transmitted to a photometer containing 10 interference filters of different wavelengths The signal is amplified and then processed by the specific electronics and by the computer The program then makes all the necessary calculations and controls so that it can finally present the concentration of th
44. and statistics generation Analysis Selection How to run a Query Select Analysis 5 jelect Method HS TEES Date Range pom From To v Male v Serum EE Female V Urine Results Range v Chid V Relation a NENNEN Num of Rec Standard Deviation Variance Correlation Coefficient Min Result 43 0 736 0 542 11 5 000 Mean Variation Coefficient Deviance Median Max Result 6 598 11 16 22 75 6 500 7 800 M D 5 900 06 02 2002 Female Serum MD 620 002202 Female F 13 M D 16 300 10670272002 Female Serum EN g u re M D 6 400 06 02 2002 Female Serum M D 5 700 06 02 2002 Female Serum M D 7 400 06 02 2002 Female Serum M D 6 500 06 02 2002 Female Serum M D 6 200 06 02 2002 Female Serum M D 7 700 06 02 2002 Female Serum M D 7 500 06 02 2002 Female Serum M D 7 600 06 02 2002 Female Serum M D 7 000 06 02 2002 Female Serum M D 7 000 06 02 2002 Female Serum M D 6 200 06 02 2002 Female Serum Print Preview Exit To perform any query it is necessary to select an analysis from the Select Analysis list Fig 13 Once selected all existing methods associated to the analysis Select Method are displayed It is possible to select among the available methods by clicking on the check box Select only particular methods In case no box is checked then the search will
45. be created by the administrator of the password the person responsible for the system administration of archives and the management of the users passwords for system access The administrator has the User Name ADMIN and any password selected by him prior to log in the factory default password is ADMINISTRATOR which should be changed on the first log in by the administrator The administrator password is the only password without System Logon expiry date while the other passwords must be changed once every three months NOTE Modify Password Password min amp chr Confirm Password amp accent Cancel The password must have at least 8 characters The administrator has no access to the instrument but to a special window for the management of users and the possibility of insertion removal of users Section I Manage Users Available Users C level Gen Deselect all 2 Delete New User List of authorized users with proper access level highlighted Q Shutdown Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 8 Page 16 of 17 Each single user is associated to a basic access level LEGEND 0 Normal user 1 User having the possibility of modification of values 2 User having access to analytical parameters 3 User with access to the diagnostic of the instrument To assign the user an access level different than it is important to know the corresponding
46. be manually activated or it starts automatically when the instrument is left inactive for more than 30 minutes The Sleep Mode automatically performs the wash and fill up of the cuvettes with bi distilled water and remains idle waiting for users commands for immediate operation 2 LOG OFF The Log Off mode represents a partial turning off of the analyzer It disables some devices Halogen Lamp of the photometer cuvettes thermostat and drive motors This mode is used for energy saving The Log Off mode is utilized for programming automatic turning on at a desired date and time The instrument will remain in a stand by condition and it will automatically turn on 30 minutes before the programmed time The turning on in anticipation 30 minutes before the programmed time allows the analyzer to reach steady state thus allowing immediate operation at the programmed time CAUTION a Do not ever stop the analyzer by turning off the main switch prior to performing the correct SHUT DOWN procedure b Improper shutdown may cause loss of data and programs and will necessitate reinstallation of the operating software Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 16 of 16 OPERATOR MANUAL BT 1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 2 2 WARRANTY CONDITIONS Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 2 Warranty Conditions BT20
47. binding contract created with the Company when a written order acceptance has been sent by the Company or the ordered goods have been shipped For orders with a value over Euro 150 00 each the goods including the packing cases are shipped carriage paid All prices listed exclude VAT and all similar taxes and the purchaser will be liable for such taxes if applicable SHIPMENTS In accordance with the general provisions of law the goods are shipped at the customer s risk even where shipped carriage free The goods with cold storage temperature between 2 8 are shipped at controlled temperature CLAIMS Any claims must be made within 10 days from the receipt of goods PAYMENT TERMS The terms of payment indicated on the invoice are valid In the event of overdue account default interest at the rate of 2 above the official discount rate will be added to the outstanding account JURISDICTION For any judicial contest legal venue for both parties is Rome Italy For further info see Biotecnica site at www biotecnica if Section IT Chapter 3 Ordering Information BT2000 PL Rev 0 Soft Ver Page 2 of 3 3 2 CONSUMABLES FOR BT2000 PLUS PRODUCT Surfactant Wash Concentrate Cuvettes washing solution Fuse 8AT 250 Volt for Analyzer Power Cord for analyzer Power Cord for peripheral devices Peristaltic Pump Cartridge Halogen Lamp 12V 35W for Photometer Tubular Filter for H20 container Distilled Water container 5 It Cubitainer
48. brief description of the icon function This is followed when available by the function key between brackets which allows for the same function or command as the icon For example the hint Reset F5 means that the function key F5 has the same function of the icon In the same way in each menu are shown when available the quick commands e g Insert Batch Ctrl B means that the same function is activated by typing simultaneously on the keyboard the keys Ctrl and GENERAL ICONS apes Cancel aborts the programming and closes the window Save Save saves the program and closes the window Print Print prints the window s contents i e parameters graphs etc om Reduces the window to the upper bar where the analyzer s name appears xil Exit exits from the window Ov Closes the application or switches off the system Windows commands Reduces the window to an icon with ALT TAB it is possible to switch between open applications even if they are reduced to icons Selections clicking on the arrow opens a selections list Closes a window or an application Reduces the window to a single upper bar where only the analyzer s name will appear An icon representing refrigeration system operation has been added to the status bar in the main menu The Refrigerator disabled state may be necessary if the operator decides not to use the refrigerator for reactions or after a refrige
49. date range Total The controls are ordered by date and hour if daily and the Out of limit is displayed only if there are known controls It is possible to delete the selected control by right clicking on a given value only if the search is made on the Daily and not on the Total The boxes of control s range and Westgard decision become invisible in case an Unknown lot is selected Once all the key data is inserted just press Search to proceed with search visualization and control processing If All is selected in the fields Lot and Method then the search will be complete for all the lots and the methods relevant to the tests selected in the Analyses field In this condition the Range values will be set to O zero The Westgard D C and Print buttons activate functions of data report printout visualization of the Westgard graphic amp Daily Chart graph Analyses Level pType BIC Ale ay p 0 Tota Lot C 2 C Unknown Date 14 12 2001 Method From Time 11 00 ToTime 13 00 vae rime Out of gt 11 0 11 36 Range Statistics 15 0 11 46 Number Mean Min 10 0 5 00 23 0 12 00 Theoretical 0 20 0 Max SD 6 86 23 0 12 21 EN 34 3 28 012 27 Westgard decision Class H Class HB Class HC Class HD Class HE Class HF Figure 3 Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page
50. dl 2 986 47 0 83 5 51 0003216 BID lt Color gt 55 1 ug L i 1 41 44 0 62 0 51 0003216 Lipasi 65 3 mg dl i 4 11 58 0 97 0 51 0003216 FAC DE ng L i 7 88 43 0 85 5 L 51 0003216 PRY 6 UI l 7 58 29 0 72 5 51 0003216 Glicenia ANC 59 1 ug L i 3 70 41 0 83 5 51 0003216 Bilirubina Jundrassik 24 7 UI l 6 43 59 0 147 51 0003216 VED 24 7 UI l 2 66 41 0 94 5 51 0003216 Colesterolo ANC 41 5 mg L 0 200 40 0 lle 51 0003216 Glucosio AX 99 6 ug L i 5 22 48 0 1082 6 CTRL2011 BID ANC 27 3 UI l 1 05 36 0 106 H6 CTRL2011 Figure 16 The Figure 16 shows the data display page for Real Time This page can be accessed through the specific icon When no data is present this page is empty It is a brief representation of data and allows real time visualization of results of tests in execution as the single tests are completed Once the results are archived the information present in this page will no longer be available Test results with flags are highlighted in red The following information is displayed for each single test a Sample Position XX Progressive Number from 01 to 52 for Routine and STAT Progressive Number from 01 to 26 for STD and CTRL b Sample code For patients Routine and STAT it is assigned at input It is automatically assigned to STD and Batch It is automatically assigned to CTRLs but it can be given by the op
51. error It does not allow the continuing of IMPOSSIBLE TO RESET working phases Restart the system computer by ANALYZER pressing the start button located under the LCD screen If the message persists contact approved technical assistance The message Synch indicates a system error It does not allow the continuing of working phases SYNCH ERROR Restart the system computer by pressing the start button located under the LCD screen If the message persists contact approved technical assistance The message System blocked indicates a_ total SYSTEM BLOCKED blockage of the system Restart the system computer CALL ASSISTANCE by pressing the start button located under the LCD screen If the message persists contact approved technical assistance Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver 8 Page 11 of 12 2 2 3 OPTICAL SYSTEM VERIFICATION MESSAGES ERROR MESSAGE CAUSES amp REMEDIES The message LAMP PROBABLY OFF is displayed after a photometric zeroing when the analyzer detects that the optical system has a lower efficiency than WARNING the minimum value stored When this message is LAMP PROBABLY OFF displayed it is not possible to continue sampling tests Replace photometric lamp see item a in paragraph 1 3 and repeat command SETLAMP refer to Chapter H paragraph 1 1 1 In case the error message still persists contact approved technical assistance The message LAMP EXH
52. is composed of a two axes based mechanical system accommodating sampling needle head with built in electronics including correct position sensor Encoder POWER SUPPLY DILUTER READING STATION NEEDLE WASTE CUVETTE WASTE MODULES 1 COMPUTER BOX 2 READING STATION 3 POWER SUPPLY 4 REAGENT MODULE 5 SERUM MODULE 6 SAMPLING ARM REAGENT BAR CODE SERUM BAR CODE Only on BT2000 PLUS Only on BT2000 PLUS Modules Arrangement Fig 5 Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 11 of 11 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER B 1 INSTALLATION 1 1 Unpacking the Analyzer 1 2 Installation 1 3 Starting the instrument 1 3 1 Turning on the instrument for the first time 1 3 2 Preliminary checks Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter B Unpacking amp Installation 2000 PLUS Page Page Page Page Page Page Rev 0 Soft Ver 8 Index ONN BND 1 INSTALLATION 1 1 UNPACKING INSTRUCTIONS Unpacking the analyzer and the accessories The crates can be easily opened by applying the lever action with a large screwdriver to remove all the spring clips on the base of the crate as shown in the Figure 1 Carefully remove the upper covering Remove the analyzer and place it on a stable vibration free surface Carefully unpack all the accessories and place them in
53. is possible to enter intervals of days and hours for automatic controls run Fig 24 Each daily interval Select the function and set interval days then enter test running time for example 1 08 30 means every day at 08 30 or in any case at start up Every hour interval Select the function and set the desired interval hours and minutes Every day or when the preset time expires the analyzer will automatically alert the user that there are controls to be run If reagents and controls are present then the user can directly confirm to execute the tests e View used positions This command displays the test disposition 1 5 CALIBRATIONS Programming The analytical calibrations that can be run by the analyzer are divided as follows Linear and Non Linear Selection occurs during the programming of the analytical test parameters refer to paragraph 1 3 3 Primary Analytical Parameters and the following and can be executed on user s request or automatically In the pages All Tests and Current Tray select desired test code then move the mouse cursor to the command Standard and click to confirm The parameters of calibration execution and verification of the preselected test are shown in the displayed page Standard parameters for XXX FFI Linear and With factor analyses j Range limit m With Factor This parameter converts absorbance ABS Factor Minimum Maximum fo E Calculation values detected
54. lin eee mg L 3 93 55 0 103 3 0009452 ug L 3 56 38 0 97 0 7 CTRL4251 56 0 mg L 6 05 RAT 51 0002151 _ UI l 4 87 46 0 119 9 CTRL6724 _ UI l 2 11 43 0 98 5 3 0009457 89 3 mg dl 6 33 44 0 80 0 w VED 51 0002151 63 0 ug L 6 00 26 0 72 0 1 9 CTRL6724 89 6 mg dl 8 96 25 0 84 5 3 0009457 98 0 ng dl 4 96 37 0 65 5 Programmi Esterni Stampa Figure 2 After the termination of programmed task the results can be viewed per Test The test Results display page is shown in Figure 2 Test results with flags are highlighted in red The following information is displayed for each single test a Sample Position XX Progressive Number from 01 to 52 for Routine and STAT Progressive Number from 01 to 26 for STD and CTRL b Sample code For patients Routine and STAT it is assigned at input It is automatically assigned to STD and Batch It is automatically assigned to CTRLs but it can be given by the operator during input The group pertinence is indicated see Chapter F paragraph 1 Quality Controls c Sample Type The relationship of Sample to one of the groups Routine STAT CTRL or STD is indicated between brackets d Results Tests results with any eventual warning flags The following commands are available in the results display page Print It provides hard copy of the entire contents of the data display page
55. line F1 FUNCTION ICONS BAR 1 To Insert New Codes Parameters Standards and Controls for all Analyses 2 To Create the On Line Reagents Tray 3 To Insert Parameters Standard and Controls for the On Line Reagents 4 To Insert Modify Profiles 5 To Insert Routine View Programmed or In Run Patients 6 To Insert Batch Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 5 of 11 7 To Run Standards 8 To Run Controls 9 Analyzer s Utilities 10 Mechanical Calibrations 11 a Results Listed per Patient b Results per test in real time 12 No Results 13 Reaction Graphs 14 Turning ofF the System Simply positioning the cursor on the icons the hint will appear where available showing a brief description of the icon function This is followed when available by the function key between brackets which allows for the same function or command as the icon For example the hint Reset F5 means that the function key F5 has the same function of the icon In the same way in each menu are shown when available the quick commands e g Insert Batch Ctrl B means that the same function is activated by typing simultaneously on the keyboard the keys Ctrl and GENERAL ICONS 8 Cancel Cancel aborts the programming and closes the window ave Save saves the program and closes the window Print Print prin
56. of error and the suggested solution The system goes into the standby mode until the causes of error are eliminated and then the operation can be resumed from where it stopped When anything necessary for test run is lacking for example reagent or sample an appropriate message is displayed on the screen sampling procedure for the missing element is interrupted while the analyzer continues with the next working phases Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver S Page 8 of 12 SCREEN MESSAGE CAUSES amp REMEDIES SAMPLE IS MISSING NO ROUTINE XX NO STAT XX NO STANDARD XX NO CONTROL XX REAGENT IS MISSING NO REAGENT XXX POSITION XX WARNING LOW PRESSURE WARNING WASTE CONTAINER FULL WARNING NO WATER THERE ARE THE FOLLOWING OBLIGATIONS IN DIAGNOSTIC EXTRA WASH NO SAMPLE DILUENT Section I Chapter L Maintenance amp Troubleshooting The error SAMPLE IS MISSING is displayed when the analyzer detects the absence of sample through a built in liquid sensor It is subdivided into NO ROUTINE NO STAT NO STANDARD NO CONTROL After this message the sampling of the missing sample is interrupted It is possible to run missing tests using the rerun commands Chapter E paragraph 1 5 The error REAGENT IS MISSING is displayed when the analyzer detects through built in liquid sensor the absence of reagent needed for test run After this message the sampling of the mi
57. of readings Number of reading i Times Readings Ll 50 8 Distance point line D Y MX Q where Angular coefficient for the line Final point for the line Point Abscissa Point Ordinate lt 2 Distance between two points 2 y Ly uy Xo where X Abscissa Y Ordinate Xo First Point Abscissa X4 second Point Abscissa Yo First Point Ordinate y Second Point Ordinate Mathematical Functions for Clinical Chemistry VOLUMETRIC FACTOR USED IN SAMPLE BLANK A TESTS 2 vS VR vS where K Volumetric factor 9 Serum volume vR First reagent volume vR2 Second reagent volume 1 2 3 INITIAL COMPUTATION The initial computation is important for transforming the microprocessor data into compatible data for the program to generate the single absorbance value which will be used afterwards for the final absorbance computation Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 8 of 31 Clinical Chemistry pop Z Log L Op eI ve Of where Z Zeroing with water F4 First Filters Value F2 Second Filters Value Fz First Filters Zero Value Fzo Second Filter s Zero Value Op Optical path Of F C C 1 2 4 OPTIMIZATION TECHNIQUES FOR CLINICAL CHEMISTRY Searching for the right reading point for Fixed Time test If the point P1 is not read exactly at To then the ABS value f
58. places that should be used to represent numerical results of the tests Alternatively if the decimal places are not programmed Automatic then the analyzer automatically sets the number of decimal places in accordance with floating point algorithm e Instrumental Factor This function introduces a constant percentage correction of the final data of the executed test It may be used for making adjustments to test data obtained from analytical methods or different type of instruments e Shift This function introduces a constant quantitative correction of final test data It may be used for making adjustments to test data obtained through analytical methods or instruments of different types 1 3 6 AUTOMATIC RE RUNS The commands Re run Serum and Re run Urine are available automatic repetition parameters for hyperactive or pathological tests in the Check Parameters table To set move the mouse cursor over the desired command and click to confirm The following functions are available in the displayed table e Normal range Min U Min Max D i normal reference values min and max Min Max B for men U women D and children B e Re run hyperactive It allows automatic re run for a hyperactive result with sample dilution Confirm with check to enable e Re run pathological it allows automatic re run for a pathological test without sample dilution Check the box to confirm and enable The Pa
59. procedure is selected then the program will begin initialization of communication with analyzer will ask for data of the next report ready for serial dispatch and show data of relevant downloaded report If there are no reports to be received then a relevant message will be displayed Every time the program waits for a response from the analyzer in case of problem it is possible to abort the current operation by simply pressing the Esc Escape key Note Both the programs must reside in the computer connected serially to the analyzer through appropriate cable indicated in the Operators Manual The computer must be an IBM compatible equipped with DOS operative system Windows 95 Windows 98 or Windows 2000 The operating systems such as MAC UNIX Windows ME or XP are not supported Since the programs operate in DOS ambience therefore in case the Windows operating system is used then it will be necessary to open a DOS shell the command Prompts of MS DOS is found in the menu Programs Accessories accessed through the Start button on the bottom left of the screen Both the programs use serial port with the following setups 9600 1 None Hardware Important Notice These two programs are in the installation disk under Utility folder Section Chapter 4 Serial Communication BT2000PL Rev 0 Soft Ver 8 Page 16 of 16 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 5 5 INSTALLA
60. programmed patient can be executed immediately or saved for later use The programming fields and the functions are outlined below Exit To leave program press Exit Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page 6 of 17 Duplicate Patient Type Serum C Urine Duplicate patient 20 Child Routine a 7595 External dilution factor Name Draw Date 06 03 02 fi 00 A Test E Profile g Delete Save Figure 6A Figure 6 Group Select the group Man Woman Child for correct reference with normal values range Type It is default set to Serum The sample type Serum or Urines is selected here If Urine is selected then the volume of diuresis in liters is requested This is required for processing data acquired with automatic calculation on 24 hours If this processing is not required then leave the value at zero 0 Assigned Group Routine or CTRL Routine The default setting is Routine It is used for selecting the category Patient or Control Serum during sample programming Selecting CTRL Routine the type Known or Unknown and levels Level 1 2 3 Low Medium High must be specified NOTE With this type of acquisition the controls belonging to the stored Q C will use the positions assigned to routine patients not the dedicated ones Positi
61. programmed time before the sample is added which starts the reaction The sampling dynamics of the above mentioned methods are tabulated as follows NORMAL SAMPLING PROCEDURE Method __ Reagent Blank Reagent Dynamic End Point Fixed Time Kinetic I R Single R1 R1 S gt Ta gt L R1 Only Read Sine HR 4 SL End Point Fixed Time Kinetic Double R1 Ta R2 Tb R1 S Ta R2 Tb L End Point Fixed Time Kinetic I R Double R1 R2 Tb R1 R2 S Tb gt L Sample Blank A R1 5 Ta 1 R2 Tb L2 Sample Blank A b bue Sample Blank L2 L1 Sample Blank Double R2 R1 5 Ta L1 R2 S Tb gt L2 Sample Blank B b Sample Blank L2 L1 Ta and Tb Incubation times for R1 and R2 L Reading SERUM STARTER SAMPLING PROCEDURE Method __ Reagent Blank Reagent Dynamic aS lh aS S S Serum Starter Tr Delay Time for R1 and R2 Ts Serum Incubation Time L Reading The way the Reagent Blank and the Reaction s Dynamics are used is tabulated below Reagent blank Final reaction datum detection at the end of programmed time for incubation and reading and concentration s value computation Fixed Time Reagent s reading check Data detection during programmed reading time absorbance delta determination AA and concentration s value computation Reagents reading check Data detection during programmed reading time determination of the absorbance delta
62. stringn PatientNumberTest 3 Number of results to be sent a string of fixed length equal to 3 characters Set BeginAnalysesData Beginning of zone repeated for the number of results to be sent see PatientNumberTest Section Chapter 4 Serial Communication BT2000 PL _ Rev 0 Soft Ver 8 Page 14 of 16 Stringn AnalysesCode 04 An analysis code of fixed length equal to 4 characters Stringn AnalysesConcentration2 7 Concentration referred to the analysis code as per AnalysesCode a string of fixed length equal to 7 characters Set EndAnalysesData End of zone repeated for the number of results to be sent Stringn CheckSum 3 Check Sum transferred as a string of fixed length equal to 3 characters 4 2 1 SERIAL COMMUNICATION TEST PROGRAMS Program COMUNICA EXE It is a simple communication program for sending command characters to the analyzer and receive any response At the start the only input to the program is the number of the communication port from 1 to 4 A blue screen divided into two sections is displayed In the upper section the characters coming from the analyzer are displayed while the lower section displays the characters sent to the analyzer The only special keys used are F1 to clear the screen and F10 for exiting the program The special characters with values less than 32 are displayed in ASCII notations along with their values For example the Character EOT value 4 will be shown as EOT 4 To s
63. then after 3 minutes it is considered automatically as a negative answer and a screen message informs that no test will be run With the analyses in process the analyzer proceeds with the calibrations But if there are no reagents or standards present this procedure is interrupted and the counting of the calibration time interval restarts The previous calibration settings remain saved in memory Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page 4 of 17 Running Controls Controls Sera can be run on command or automatically according to programmed time intervals refer to Chapter C paragraph 1 4 Controls The two modes can coexist Commands are Immediate Controls and Timed Controls Fig 4 Immediate Controls Clicking this button generates a list of codes Select the desired tests and run by pressing Run With Select All or Deselect All commands it is possible to select or deselect the whole list A message will ask the user whether the control samples are already present in the tray or not If samples are already present click Yes and run will automatically start Otherwise if controls samples aren t already placed on the tray click No in this case a guided procedure is presented for samples insertion By clicking over sample s position the tray moves itself to accommodate cup s insertion After the insertion of necessary cups run the controls Timer drive
64. to place the solutions when needed and to ensure correct execution of washing procedures In case the washing procedures are not performed during shutdown then at the next restarting of the analyzer before any sample run the system will display a message inviting the operator to perform the required washings Bear in mind that it is not possible to ensure data precision and accuracy if the normal washing and maintenance procedures are not observed RS232 This command is active only when the serial communication is enabled see Analyzer Setup Chapter H paragraph 2 It allows the analyzer to send data to the host computer upon operator s request Log Files A memory location in which all the operations performed by the analyzer are stored This function is divided in two parts the first part memorizes the type and the number of tests performed the second stores the errors and the incorrect procedures This read only area is very important for the Technical Assistance service personnel External Programs Menu Fig 5 External Programs The functions in this menu are outlined in the Chapter F Quality Cantral Population Patient Archive Fig 5 Two buttons lt amp gt have been introduced on the title bar in the screens of standards and controls analysis parameter insertion These buttons allow for moving to previous or successive analyses without returning to the initial page LEER Successive
65. to remove dust grease and other contamination Use soft dusting cloth dampened with distilled water or a mild solution of detergent with water Do not use alcohol solvents or abrasives Use appropriate soft lintless cloth or tissues for LCD Display cleaning Clean gently and avoid excessive rubbing to prevent damage to the LCD Display surface Do not use any liquid that may damage the invisible matrix of the touchscreen Protective gloves and laboratory coats gowns should be worn to prevent contamination when cleaning the inside of the reagent chamber or serum plate chamber because of liquid contaminants Use appropriate disinfectant for the thorough cleaning and elimination of biological residues Clean the cuvettes thoroughly with approved washing solution Immediately eliminate any traces of serum drops or liquid contaminants using appropriate disinfectant to avoid difficulties associated with removal of dry and tenacious contaminations Handle cuvettes with protective gloves Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver S Page 7 of 12 2 MALFUNCTIONS 2 1 TROUBLESHOOTING The risk of encountering system malfunctions is very low if the routine care and maintenance procedure outlined in the previous chapter and the instructions in the operating manual are strictly observed Refer to the troubleshooting guide below and the subsequent text regarding symptoms and corrective actions SYMPTOMS CORRECTIVE
66. used or applied symbols 4 BRIEF DESCRIPTION OF THE SYSTEM 4 1 Front view of the analyzer 4 2 Rear Panel Controls and Connectors 4 3 Modules CHAPTER B 1 INSTALLATION 1 1 Unpacking the analyzer 1 2 Installation 1 3 Setting up the instrument 1 3 1 Turning on the instrument for the first time 1 3 2 Preliminary checks CHAPTER C 1 FUNCTIONS 1 1 Description of the Program Menu 1 2 Operating principles 1 2 1 Computations 1 2 2 Applied mathematical functions 1 2 3 Initial computation 1 2 4 Optimization techniques for Clinical Chemistry 1 2 5 Methods Description Index BT2000 PLUS Rev 0 Soft Ver 8 Page l of 4 Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page cd DOONAN INDEX BT2000 PLUS Operator Manual 1 3 Analyses Programming 1 3 1 Creating a New Code 1 3 2 Relation Tests 1 3 3 Primary Analytical Parameters 1 3 4 Check Parameters 1 3 5 Secondary Analytical Parameters 1 3 6 Automatic re runs 1 4 Controls 1 5 Calibrations 1 6 Creating Profiles 1 7 Creating the Current Analyses Tray CHAPTER D 1 PERFORMANCE AND LIMITS CHAPTERE 1 OPERATIING PROCEDURE 1 1 Turning on procedure 1 2 Reagents insertion and removal 1 3 Running Standard and Controls on demand or timed 1 4 Samples 1 5 Work Lists 1 6 Turning off procedure 1 7 Access
67. wa Ipape 7 z z 264 i 1 t t y ad TON n b V 4 iM 1 a amp Select the desired background picture and set Stretch in the Picture Display Click OK Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 16 of 22 If a question is asked then respond by clicking Yes The Operating System is now configured correctly and one may proceed to the installation of the drivers of the peripheral devices e g Additional Serial port Touchscreen and printer CAUTION The supplementary drivers must be installed prior to installation of the BT2000 PLUS operating program in the system Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 17 of 22 9 5 INSTALLATION OF THE BT2000 PLUS OPERATING PROGRAM Insert the CD ROM containing the operating program of the BT2000 PLUS in the CD ROM drive The following screen appears Auto run feature Launch Setup Explore CD gt Exit to Windows gt Click LAUNCH SETUP Now the installation procedure begins which will guide the user during operating program installation pwr I E bt Plus Setup Welcome to Analyzer Installation The InstallShield Wizard will install bt Plus on your computer continue click Next lick N fistart 57 Eve Plus Setup Click NEXT Section
68. want to restart my computer now y 7 gt LT will restart my computer later 4 esol lick Finish to exit bt Plus setup xplorer Connect to the Internet Finish Cancel e 7 5 5 wizard Now click Finish Now the proper installation procedure begins Open and close the CD ROM drive to enable autorun automatic starting of the BT2000 PLUS Proceed with installation as for a new instrument Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 22 of 22 OPERATOR MANUAL BT 1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 6 6 TECHNICAL ASSISTANCE Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section IT Chapter 6 Technical Assistance BT2000 PL Rev 0 Soft Ver Index 6 TECHNICAL ASSISTANCE Please do not return any equipment or system before discussing your application problem with a Biotecnica Instruments S p A representative and obtaining a Return Authorization The Technical Assistance Department at Biotecnica Instruments S p A or your Biotecnica representative is available for your assistance For other analyzer applications your Biotecnica representative or Biotecnica Instruments S p A is eager to help you Please feel free to call your representative or the number below to discuss your application INSTRUMENTS S p A Via Licenza 18
69. 00 PL Rev 0 Soft Ver 8 Index 2 WARRANTY CONDITIONS e Instruments S p A after having accurately tested this analyzer guarantees the instrument for 1 one year starting from invoice e warranty includes the repairing and the replacement for free of the faulty parts due to wrong manufacturing Warranty is not extended to the normally consumable parts of the system e warranty is not valid in case of improper use negligence improper or lack of maintenance and cleaning tampering or repairing by third parties not authorized by Biotecnica Instruments S p A and in any case when the cause cannot be stated as original manufacturing fault e costs of shipment and transport to Biotecnica Instruments S p A for repair or substitution and the risks deriving from this is the responsibility of the buyer including all the costs of onsite technical service at client s location transport board and lodging as well e fthe stated defects will result to be out of warranty limits the buyer will pay repair or replacement costs e Instruments S p A is not responsible for any unforeseen technical problem that might occur If the requested technical assistance is outside the terms of warranty a charge will me made to the customer as per current rates in force e Biotecnica Instruments S p A is an internationally known for its high quality standards production Biotecnica Instrum
70. 000 PL Rev 0 Soft Ver 5 Page 3 of 6 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 DO NOT ATTEMPT TO ALTER THE SHAPE OF ANY PART OF THE SYSTEM IF THE SYSTEM IS NOT OPERATING PROPERLY AND THE TROUBLE SHOOTING SECTION refer to Chapter N DOES NOT PROVIDE A SATISFACTORY SOLUTION TO THE PROBLEM THEN DO NOT USE THE SYSTEM UNTIL THE DEFECTS ARE REMEDIED INSPECT ALL ACCESSORIES AND SYSTEM CORDS DO NOT USE IF DAMAGE CAN BE SEEN SUCH AS CUT INSULATION OR OUTER COVERING FRAYED OR BROKEN WIRES CORRODED OR BROKEN CONNECTORS ETC TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK DO NOT ALLOW FLUIDS OR ANY FOREIGN OBJECT TO ENTER THE SYSTEM WIPE OFF SPILLS IMMEDIATELY DO NOT USE BENZENE THINNER ANY KIND OF SOLVENTS OR ABRASIVE DETERGENTS TO CLEAN THE CASE CLEAN WITH SOFT DUSTING CLOTH DAMPENED WITH DISTILLED WATER IF NECESSARY USE ONLY NEUTRAL DETERGENT DO NOT STICK OBJECTS OF ANY KIND INTO THE SYSTEM THROUGH BACK PANEL OR CASE SLOTS AS THEY MAY TOUCH DANGEROUS VOLTAGE POINTS OR SHORT OUT PARTS THAT COULD RESULT IN FIRE OR ELECTRIC SHOCK INSTALL THE SYSTEM IN SUCH A WAY THAT ADEQUATE VENTILATION IS PROVIDED ALL AROUND TO PROPERLY DISSIPATE THE HEAT USE ONLY ORIGINAL TUBING REPLACEMENTS MONTHLY AND QUARTERLY REPLACEMENT KITS DO NOT USE CONVENTIONAL TUBING THIS WILL CAUSE MALFUNCTION OF THE SYSTEM MAKE SURE ALL FLUID LINES ARE FREE OF KINK
71. 000 T Automatic C Custom 0 000 0 000 Womar fo O00 0 000 Child Figure 9 In the parameters window fig 9 enter the following information Name complete test name 15 Unit measurement unit Clicking on the 2 Unit it is possible to enter a secondary unit with its conversion factor the analyzer will multiply the 1 unit by the given factor Supplementary Factor The result of the mathematical function will be multiplied also by this value This is simply an additional calculation offered by the analyzer Normal Range insert the min and max values of the normal range for male female and child Decimals it is possible to choose the number of decimals after the point Leaving the Automatic option the analyzer will follow this principle floating point for values like O XXX three decimals for values up to 9 XX two decimals for values up to 99 X one decimal for values over 100 no decimals To enter the mathematical function select Function MUC PHO PRO D 1 Figure 10 Figure 10A A window divided in two parts will be displayed one for the calculator and one for the analyses list current tray Fig 10 The mathematical function can be composed of simple values and operations or can recall sample results acquired by the analyzer serum and urine on other tests complex f
72. 00156 ROME ITALY Tel 39 06 4112316 Fax 39 06 4103079 Technical Assistance E mail ciucci biotecnica it Biotecnica E mail bt biotecnica it Webs ite www biotecnica it Section IT Chapter 6 Technical Assistance BT2000 PL Rev 0 Soft Ver S Page 2 of 2 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 7 7 BIBLIOGRAPHY OF ALLIED SUBJECTS Page 2 NOTE The following bibliography is given to supplement this manual whose scope as an operator manual permits only the mention or brief explanation of some subjects Biotecnica Instruments S p A Via Licenza 18 00155 Rome ITALY Section Chapter 7 Bibliographical Reference BT2000 PL Rev 0 Soft Ver 8 Index BIBLIOGRAPHY OF ALLIED SUBJECTS Burtis C A Ashwood E R Tietz Textbook of Clinical Chemistry 11 Ed W B Saunders Company 1994 Press W H Flannery B P Teukolsky S A Vetterling W T Numerical Recipes The Art Of Scientific Computing Cambridge Univ Press 1986 EN 591 1994 In vitro diagnostic systems Requirements for user manuals for in vitro diagnostic instruments for professional use ital UNI 96 EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements amendment to IEC 1010 1 1990 A1 1992 EN 1658 1996 Requirements for marking of in vitro diagnostic instruments Directive 98 79 EC on in vitro diagnostic m
73. 3 of 20 1 3 DISPLAYING amp PROCESSING BY LOT PAIRS JUDEN GRAPH After selecting the key parameters Analyses Lot Method Known Unknown and Level data processing and visualization is performed The controls are ordered by date and only in case of known controls the Out of limit condition is indicated Refer to Figure 4 This function relates two different levels for the same lot displaying distribution of controls within the limits of lots Level Axe Y C fi 2 C 3 Method Start Date End Date TRINDER 7 11272001 1471272001 AB Search Opin Value Axe X Vale Date 2 D 20 0 14 12 2001 F g ure 4 Value Axe Y Value __ Out of imit n 4 60 14 12 2001 By clicking over a value plotted on the graph the information relating the pair of values will be displayed Westgard graph The Westgard graph provides a global vision of a given lot by plotting data on a diagram having the origin at 0 line representing the actual mean not the theoretical value of the same lot and as division values such as 15 to 45 and 15 to Mean 4S see Westgard table in Figure 5 All data within the given range will be displayed with a green triangle while the out of range data will be plotted using red squares Westgard graph _ dad EET Method TRINDER Type Known Figure 5 Secti
74. 7000 Pro C d gt i y T DU is Setup ses th T A i E uses th 2 id F y L IN vir BAM 2 Juin TOM DS neo eoe e tee We ene A A Enter bt 2000 plus as Name and biotecnica instruments S p A as Organizzazione Click NEXT key Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 7 of 22 Now type the Product Key of Windows the Product Key is composed of 5 groups of 5 characters each 4 Windows 2000 Professional Setup identifi ait HH LATTE ATs AE HY ep dy 1 pern Fm Manz _ The 25 character Product Key appears on the installation CD ROM cover After typing the Product Key click NEXT key In case of incorrect Product Key entry a message will alert the operator to enter the correct Product Key Now provide the Administrator Password for your system pondo ws 7000 Professiona EE Yos des m Adi ministra stor P a i name andan 1211 Q1 4 In the field Administrator Password type ENZO and rewrite it in the field Confirm Password Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 8 of 22 In case the board has a LAN network communication hardware then the following screens will be displayed ional Setup a collection of WORKGROUP Do not change the default parameters and click
75. ACTIONS The instrument or one of its Verify that the UPS group is turned on the electrical cables peripheral devices does correctly connected and check the fuses If fuses need replacement then observe the following procedure 1 Turn off the instrument by pressing the main switch on the rear panel and unplug power cord 2 Extract the fuse holder located above the main switch on the rear panel by gently opening the latch with a tool Discard the old fuses and replace with new fuses which match the selected voltage rating indicated on the rear panel label Insert the fuse holder into the compartment and push until its latch snaps back into the position see Figure 3 Chapter B Invalid results or cannot be Defective or burnt out lamp reproduced Inspect and replace the lamp refer to item a in paragraph 1 3 Photometric lamp replacement Invalid results or cannot be Perform all maintenance procedures and check all possible reproduced without any causes described earlier in this chapter evident reason 2 2 SCREEN MESSAGES 2 2 1 SCREEN MESSAGES CAUSES AND REMEDIES The BT2000 PLUS software has a built in Auto diagnostic function which is enabled during normal working sessions This function allows verification of any system malfunction or lacking of any solution necessary for running the tests In presence of any system malfunction an appropriate message is displayed on the screen indicating the type
76. ALUE Maximum Value String ANALYSESUM 1 1st Unit of Measurement otring ANALYSESUM2 2nd unit of measurement otring ANALYSESUMFACTOR Unit Factor String ANALYSES2RESULT Does the 2nd result exists String Character ANALYSESSERUMTYPE Method Type String Character ANALYSESURINE24H Urine in 24 h String Identifies Male Female or Child Select one of these M Male PF Female C Child 2 Identifies Routine or STAT Select one of these Routine o STAT Transmitting patient from archive will always have identifier of Routine 9 Identifies Serum or Urine Select one of these e Serum U Urine Identifies Clinical Chemistry ISE Module or Relation Analysis Select one of these C Clinical Chemistry ISE Module R Relation Analysis Identifies if the 2nd result exists or not Select one of these Y 2nd result exists N 2nd result does not exist e f only the final result is desired then always refer to variables pertaining to 2nd result e Incase of the absence of 2nd result then its variables will have the same values of the 1st result Section Chapter 4 Serial Communication BT2000PL Rev 0 Soft Ver 8 Page 10 of 16 TABLE 1 RECEPTION The following variables are used for reception of a patient by the analyzer Variable PATIENTCODE PATIENTNAME PATIENTSURNAME PATIENTLISTTYPE PATIENTGROUP PATIENTTYPE PATIENTURINE24H PATIENTNOTE PATIENTISCONT
77. AUSTED is displayed after a photometric zeroing when the analyzer detects that the optical system has a lower efficiency than the minimum value stored The sampling tests are WARNING stopped instantly after this message Replace the LAMP PROBABLY photometric lamp see item a in paragraph 1 3 and then perform an Extra wash Afterwards perform a EXHAUSTED Wash and Fill Up followed by a cycle of SETLAMP refer to Chapter H paragraph 1 1 1 If after observing these steps the message no longer appears then it is possible to continue testing In case the error message still persists contact approved technical assistance The message ERROR IN OPTICAL GROUP is ERROR IN OPTICAL displayed after resetting the analyzer and indicates an GROUP optical group malfunction Contact approved technical assistance CUVETTES The message CUVETTES TRANSMISSION OUT TRANSMISSION OUT OF OF LIMITS is displayed after a photometric zeroing LIMITS when the analyzer detects optically unusable cuvettes The sampling tests are stopped instantly after this message Replace the photometric lamp see item a in paragraph 1 3 and then perform an Extra wash Afterwards perform a Wash and Fill Up followed by a new Photometric Zeroing refer to Chapter H paragraph 1 1 1 If after observing these steps the message no longer appears then it is possible to continue testing In case the error message still persists contact approved t
78. Bar icon n 2 Once the Current Tray is created it will be possible to assign a position to each reagent bottle 1 3 1 CREATING A NEW CODE Open the analysis programming page and select New Code Enter the tests code and select the Test Type among the options showed by clicking on the button Y The test type defines whether the programmed test is a Clinical Chemistry or a relation test mathematical computation refer to paragraph 1 3 2 Relation tests Use the button Save to memorize the test or press Cancel to exit and abort programming Any code can be deleted with Clear Code or modified with Rename Once a code is set it is possible to program the analytical parameters see paragraph 1 3 3 and the following 1 3 2 RELATION TESTS Print parameters Print Controls Print Standards 002 003 B zi sl Functions e e o New Code Clear Code Rename Parameters Standards Controls Figure 8 Once the code has been created for the relation test as shown in Fig 8 it is possible to program its general parameters and the related mathematical function In the analyses list click on the code the check symbol will be displayed then select Parameters Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 15 of 31 Parameters For Relation tests Code Name Jaw E 1 st Unit 2nd Unit Supplementary Factor Decimal Ja 000 0
79. C Control NO Sample YES Control SAMPLE Sample CONTROL Control Identifies a Known or Unknown Control Select only one of these 0 Unknown 1 Known 0 Unknown male Known N Unknown b Known U Unknown K Known NO Unknown YES Known UNKNOW Unknown KNOW Known Identifies Control Level Select only one of these 1 Level 1 2 Level 2 3 Level 3 T Level 1 2 Level 2 9 Level 3 d Level 1 N Level 2 A Level 3 LOW Level 1 NORMAL Level 2 ABNORMAL Level 1 Identifies if it is a Clone Select only one of these 0 Normal 1 Clone 0 Normal T Clone N Normal Y Clone NOCLONE Normal CLONE Clone Section Chapter 4 Serial Communication BT2000 PL Rev 0 Soft Ver 8 Page 12 of 16 TABEL 2 INTERNAL VARIABLES Variables Decima Hexadecimal SCRIPT EXAMPLES The examples outlined here are the transformation in script of the standard routine of the patient reception by the analyzer Stringn PatientCode 15 Char PatientListT ype Char PatientType Char PatientClone Stringn PatientCupPosition 2 Stringn PatientNumberTest 2 Set BeginAnalysesData Stringn AnalysesCode 4 Set EndAnalysesData Stringn CheckSum 3 Section Chapter 4 Serial Communication BT2000 PL Rev 0 Soft Ver 8 Page 13 of 16 The following are the detai
80. Chapter M paragraph 1 1 Potential risks during use and maintenance The components that are most subject to wear are the fluidic tubing used in the pinch valves the peristaltic pump cartridges and the photometric lamp The hydraulic circuit items not mentioned in the maintenance table should be considered as non consumable and should be replaced only by the qualified technical personal during service Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver Page 2 of 12 5how Diagnostic x 29 x Clear Diagnostic Far Phase Life cycles Missing cycles Replacement date Tubes and Peristaltic pump OR EE A203 Tropea Kit Tubes and Peristaltic pump Extra Wash 1047 2004 Photometric Lamp 1500 Hours 3172005 Photemetnc Lamp 71500 Hours Figure 1 1 2 REPLACING TUBING AND ACCESSORIES The components that should be replaced are clearly indicated in the Figure 2 The items that don t require routine replacement are not indicated for simplification There are two tubing and accessory kits for six month and annual maintenance Six Month Maintenance Kit Reading Station for special tubes exposed to wear and tear including pump cartridges etc and an annual maintenance kit for Reading Station and for an over all maintenance When installing any tubing kit it is important that the hydraulic circuit is empty To avoid any undesired liquid spills disconnect the external water input
81. Cleaning Tool for Arm Needle Waste Container 10 It Cubitainer Sampling Needle Six Monthly Maintenance Kit Annual Maintenance Kit Serum Capsule 2 ml Reagent Bottle 50 ml Reagent Bottle 20 ml Reagent Bottle 10 ml 10 ml TUBE Section II Chapter 3 Ordering Information PART NO 392 393 330 6342B 330 6391 330 6400 330 9072 330 9321 330 9614 660 4002 662 0629A 662 1010 662 1011 662 2000 662 2001 667 1040 667 1073 667 1074 667 1076 667 1081 BT2000 PL SIZE 2x50 ml 1 liter 1 LI Ll Lll 1 min 1000 Rev 0 Soft Ver 8 Page 3 of 3 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 4 4 Software 4 1 Serial Communication Pade 2 BT2000 PLUS lt gt Host Computer ge 4 2 Variable communication protocol Page 5 4 2 1 Serial communication test programs Page 15 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section Chapter 4 Serial Communication BT2000PL Rev O Soft Ver 8 Index 4 SOFTWARE 4 1 SERIAL COMMUNICATION BT2000 PLUS lt gt HOST COMPUTER General The analyzer BT2000 PLUS allows bi directional communication through RS 232C serial connection with any host computer The particular feature of the dialog is that it is always the host computer which initiates the communication for either transmitting patient list or for receiving the results To initiate any communication the
82. EE Identifies numbers of reports C eme First test code 000 000 GLI test result BUN EE oecond test code 0010 10 BUN test result CORE Third test code 00100 0 COL test result MOT a Identifies the Check Sum lt e ipud This character ends communication Calculation of Check Sum This procedure calculates a Control code in accordance with the transmitted or received data An algebraic sum of ASCII values of all the sent characters is executed For example the character A has ASCII value 65 0x41 Consequently the module 256 of the found value is executed balance of dividing the value by 256 This is the Check Sum to be sent Section Chapter 4 Serial Communication BT2000 PL 0 Soft Ver S Page 4 of 16 Wiring Diagram of Interface Cable ead m dmm BT2000 PLUS Figure 1 1 2 3 4 5 6 7 ag co j m N amp umm BT 2000 PLUS iH Figure 2 4 2 VARIABLE COMMUNICATION PROTOCOL Introduction The variable serial protocol has been designed to provide the user with possibility to personalize the transmitted and received data from the analyzer The user can transmit or receive in addition to preset data patient code analysis code results etc also the simple text strings and or characters in order to meet the personal requirements Not only the user can decide t
83. Exit Exits from data display page Section I Chapter G Displaying and Printing Results BT2000 PL Rev 0 Soft Ver 6 Page 4 of 7 1 3 DISPLAYING REAL TIME DATA 51 0003216 RAT 51 0003216 BID lt Color gt 51 0003216 Lipasi 51 0003216 FAC 51 0003216 PRY 51 0003216 Glicemia 51 0003216 Bilirubina lt Jundrassik gt 51 0003216 VED 51 0003216 Colesteroloa ae 51 0003216 Glucosio AUC 6 CTRL 2011 BID ANGUS H6 CTRL2011 41 7 UI dl 2 98 47 0 83 5 55 1 mg L 1 21 44 0 82 0 66 3 mg dl 4 11 58 0 97 0 7 38 mg L 7 88 43 0 85 5 62 6 UI l 7 58 29 0 72 5 59 1 mg L 3 70 41 0 83 5 24 7 UI l 6 23 59 0 147 54 7 UI l 2 66 41 0 94 5 41 5 mg L 0 200 40 0 112 39 6 ug L 8 22 48 0 102 57 3 UI l i 1 05 38 0 106 Figure 3 The Figure 3 shows the data display page for Real Time This page can be accessed through the specific icon When no data is present this page is empty It is a brief representation of data and allows real time visualization of results of tests in execution as the single tests are completed Once the results are archived the information present in this page will no longer be available Test results with flags are highlighted in red The following information is displayed for each single test a Sample Position XX b Sample code c Surname Name d Sample Type
84. FROM UPS Figure 3 CONNECTING MOUSE AND KEYBOARD Keyboard and mouse are cordless and work by radio transmission The receiver with PS 2 adapter should be plugged into the appropriate port on the rear panel The receiver has two cables with colored connectors that should be plugged into the respective ports of the same color They are generally violet for keyboard and green for mouse Figure 4 Receiver mouse and keyboard should be already tuned If not then observe the following procedure Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 5 of 9 plOUSE KEYBO AM CONNECOTRS Figure 4 Figure 5 Turn on the analyzer after program loading system boot is finished press connect button on the receiver and then press connect button on mouse Next press connect button on receiver again and press connect button on keyboard rear Refer to Figure 5 Connect buttons are generally located on the rear and can be pressed with the tip of the pen or pencil Test mouse and keyboard and eventually repeat the tuning operation starting from the receiver These devices need tuning only once from BT 2000 PLUS from BT 2000 PLUS ie Pot Fig 6 PRINTER Refer to Figure 6 for connections FLUIDIC CONNECTIONS The external fluidic manifold Figure 7 located at the bottom left of the rear panel has three connectors dedicate
85. In case of two units of measurements the test value is expressed in two results In the analytical calibrations the 1st Unit of measurement is used If Urine is selected then it is possible to enter a specific unit of measurement and therefore a conversion factor between the measurement unit used in the Serum and the one used in the Urine e Dynamic Blank This parameter can be enabled or disabled If the parameter is enabled then the analyzer quantifies and memorizes the photometric drift of the blank by processing only the reagent as sample After the determination of the Reagent Delta ABS this value is then subtracted from the Sample ABS value The value of Reagent Delta ABS is then visualized in the STANDARD page adjacent to the absolute value of the reagent Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 23 of 31 Number of needle washes Normally one washing is sufficient however in case of highly contaminating tests more washings will be necessary To set washing numbers maximum 9 washings in accordance with the contaminating force of the used product press the up down arrow keys or move the mouse cursor inside the dedicated box and enter directly the value With this command the user can set the number of washings to be performed after the dispensing of the reagent used for the test in the programming phase e Number of cuvette washes Normally only one washing is sufficient but in the case of
86. KEYBOARD P N 330 2055 amp P N 330 2176 WITH CONNECTING CABLE n BT 1000 ONLY 1 PRINTER P N 330 2172 0 0 0 0 0 0 0 1 SURFACTANTWASH CONC 2x50 ml P N 392 1 1 WASHING SOLUTION FOR CUVETTE 1 liter P N393 1 FUNNEL CAP OPENER TOOL 90 05201 01 1 2 FUSES 250 VOLT 8AT P N 330 6342B 1 1 1 1 QUARTZ HALOGEN LAMP 12 35W 9 P N 330 9321 1__ SIX MONTHLY MAINTENANCE 662 2000 1 ANNUAL MAINTENANCE KIT 662 2001 0 1 CLEANING TOOL FOR SAMPLING NEEDLE 662 0629A 2 CUBITAINER 10 LITERS WITHBOX P N6621010 1 WASHING PISTON GRIP SLEEVE TOOL 662 1025 1 000 TRANSP SAMPLE CAPSULE 2ml STD amp CTRL 667 1040 50 REAGENT CONTAINER 50 ml WITH CAP 667 1073 25 REAGENT CONTAINER 20 ml WITH CAP 667 1074 25 REAGENT CONTAINER 10 ml WITH CAP 667 1076 2 10 ml TUBES 667 1081 gt Z 9 y Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 3 of 9 Verifying eventual damages occurred during shipment It is highly recommended to accurately verify the instrument and its accessories for any damages that could have occurred during shipment In case there is a damage or missing items then please fill out all the sections of the Mod 05 35a in this manual in the SECTION ll CHAPTER 2 WARRANTY CONDITIONS Send it to your neare
87. NTLED OR REPAIRED BY ANYONE WHO HAS NOT BEEN QUALIFIED BY THE MANUFACTURER INCORRECT WORK MAY CAUSE FIRE OR IRREPARABLE DAMAGE TO THE SYSTEM DO NOT OVERLOAD ACCESSORIES POWER OUTLETS AND EXTENSION CORDS AS THIS CAN RESULT IN FIRE OR ELECTRIC SHOCK DO NOT PLACE THE SYSTEM ON AN UNSTABLE CART STAND OR TABLE THE SYSTEM MAY FALL CAUSING SERIOUS INJURY TO USER AND SERIOUS DAMAGE TO THE APPLIANCE PLACE THE SYSTEM ON A STABLE VIBRATION FREE LEVEL TABLE OR CART USE ONLY SECURE POWER SOURCE TO PROTECT THE ANALYZER SYSTEM AGAINST POWER SURGES DISCONNECT TEMPORARILY THE ANALYZER POWER CORD FROM THE WALL OUTLET IN CASE OF BAD ATMOSPHERIC CONDITIONS DO NOT OIL ANY PART OF THE SYSTEM EMPTY WASTE CONTAINERS WHENEVER THEY ARE FULL ENSURE THAT THE CONTAINER LIDS ARE SCREWED ON TIGHTLY TO PREVENT LEAKAGE OR DISPERSION INTO THE ENVIRONMENT THE SAFE DISPOSAL OF THE ANALYZER WASTE MATERIAL WITH MINIMAL ENVIRONMENTAL IMPACT IS THE RESPONSIBILITY OF THE USER DO NOT ATTEMPT TO REMOVE ANY PANELS OR COVERINGS OF THE ANALYZER SYSTEM WHILE THE SYSTEM IS IN OPERATION AFTER OPERATION SERVICING COVER THE SYSTEM WITH A PROTECTIVE PLASTIC OR CLOTH SHEET DO NOT USE SOFTWARE DISKS OF UNKNOWN ORIGIN IN THE ANALYZER COMPUTER AS THEY MAY INTRODUCE VIRUSES DO NOT USE THE COMPUTER OF THE ANALYZER FOR ANY OTHER PURPOSE THAN THE ONE FOR WHICH IT IS DESIGNED FOR BE PARTICULARLY CAUTIOUS THAT NO PARTS OF YOUR BODY e g FINGERS HAIR ETC OR LOOSE
88. ONS 1 1 Potential risks during operation and maintenance 1 2 Interferences and actions to be avoided 1 3 Waste disposal 1 4 Safe disposal of the unusable instrument CHAPTER L 1 MAINTENANCE AND CARE 1 1 Preventive maintenance and Extra Wash 1 2 Replacing tubing and accessories 1 3 Additional Maintenances 1 4 Cleaning the Instrument 2 MALFUNCTIONS 2 1 Troubleshooting 2 2 Screen messages 2 2 1 Screen messages Causes and remedies 2 2 2 Messages requiring technical assistance 2 2 3 Optical verification messages CHAPTER M 1 TECHNICAL SPECIFICATONS SECTION Il SUPPLEMENTARY INFORMATIONS CHAPTER 1 1 ABBREVIATED OPERATING INSTRUCTIONS 1 1 Turning on and preliminary procedures 1 2 Inserting Reagents in Clinical Chemistry 1 3 Analytical calibrations and Controls 1 4 Entering Patients and Work Lists 1 5 Running Tests 1 6 Displaying and Printing Results 1 7 Turning off the analyzer Index BT2000 PLUS Rev 0 Soft Ver 8 Page 3 of 4 Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page N WN C ob INDEX BT2000 PLUS Operator Manual CHAPTER 2 2 WARRANTY CONDITIONS CHAPTER 3 3 ORDERING INFORMATION 3 1 General terms and conditions for sale 3 2 Consu
89. ONS Page 3 of 4 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 3 3 ORDERING INFORMATION Page 2 3 1 GENERAL TERMS AND CONDITIONS FOR SALE Page 2 3 2 Consumables for BT2000 PLUS Page 3 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 3 Ordering Information BT2000 PL Rev 0 Soft Ver Index 3 ORDERING INFORMATION Please contact Biotecnica Instruments S p A for any configuration or special requirement not covered in this manual For technical or ordering assistance start with our convenient ordering check list located in the ensuing paragraph 3 2 For further assistance don t hesitate to call the Biotecnica Instruments S p A or your local sales representative office To obtain accessories spare parts address order or enquiry to your Biotecnica Instruments S p A sales service representative or to Biotecnica Instruments S p A and supply the following Informations a Instrument Model and Serial Number b Quantity of parts desired Part Number d Description Biotecnica Instruments S p A Via Licenza 18 00155 Rome ITALY Phone 39 06 411 2316 Fax 39 06 410 3079 E mail obt biotecnica it NOTE DUE TO IMPROVEMENTS IN DESIGN AND OR SPECIFICATIONS SOME PRODUCTS MAY DIFFER SLIGHTLY FROM THE PREVIOUS DESCRIPTION 3 1 GENERAL TERMS AND CONDITIONS FOR SALE ORDERS All telephone or written orders placed by the customer are considered a
90. OOD EXTERNAL GROUND 4 DO NOT INSERT REMOVE EXTERNAL DEVICES CONNECTORS WITH POWER ON H O INLET 5 REFER TO INSTRUCTION MANUAL FOR INSTALLATION AND OPERATION PROCEDURES FISHER CONNECTOR WALL OUTLET AND MAINS POWER INLET BEFORE REPLACING ANY FUSE Pal al al a a me me ee we me ee i TP TF WASTE PROBE OVERFLOW TUBE Rear Panel Fig 3 Connectors Computer Box Fig 4 Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 10 of 11 4 3 MODULES The BT2000 PLUS analyzer is constructed of a one piece stainless steel structure The injection molded body in Baydur is placed on the chassis to cover the instrument Fig 5 shows the modular composition of the instrument Each module has its own specific function Modules definition e COMPUTER BOX consists of LCD Monitor Touch screen Main board Power Supply and peripheral devices e READING STATION MODULE comprises cuvette plate photometer diluter reading unit washing station H2O reservoir and electronics e POWER SUPPLY MODULE houses the main power supply of the analyzer e REAGENT TRAY MODULE is composed of the rotating reagent s tray the refrigeration chamber the bar code reader and the electronics e SAMPLE TRAY MODULE is composed of the rotating samples tray the bar code reader the sample tube sensors the washing wells and the control electronics e SAMPLING ARM
91. OPERATOR MANUAL BT 1000 amp BT2000 PLUS P N MO 04840 02 ING SOFTWARE VERSION 8 Rev 0 28 September 2004 This product conforms to the safety requirements of the Council Directives 98 79 EEC of 27 October 1998 European Parliament regarding the In Vitro Diagnostic Medical Devices This directive is in accordance with the Article 2 Paragraph 2 of the Directive 89 336 EEC which ceases to apply to the products complying with the present directive Refer to Paragraph 7 Article No 1 of the IEC Official Gazette No L331 of Dec 1998 It also conforms to Italian Regulations CEI EN 61010 01 and CEI EN 61326 1 EMC The conformity is attested when the equipment is installed in accordance with the conditions outlined in the manual Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Tel 39 06 4112316 Fax 39 06 4103079 E mail bt biotecnica it Website INDEX BT2000 PLUS Operator Manual IMPORTANT NOTICE The introduction of access passwords has been rendered mandatory since 2004 for safeguarding sensitive data refer to CHAPTER E paragraph 1 7 NOTE This manual is valid for both BT1000 and BT 2000PLUS The following components are not installed on the BT1000 a Reagent refrigerator b Barcode c Touchscreen d Cordless Keyboard amp Mouse SECTION I GENERAL INFORMATION CHAPTER A 1 INTRODUCTION 2 BASIC OPERATING PRINCIPLES OF THE ANALYZER 3 SYMBOLS explanation of the
92. PROFILES this function creates modifies analyses groups useful when checking in patients It can be accessed from Tests menu or from the specific icon that allows direct access Figure 28 Save Memorizes data Exit To leave exit the program It is possible to delete update and print an already existing profile Creating a profile click over New button the Profile Name textbox will appear Enter the name for the profile and click on Analyses this will open a window where it will be possible to select the analyses for the profile Click Save to store the selected analyses Fig 29 It is possible to enter in the Code for Bar Code field a numerical code used by the analyzer for bar code scanning option This code allows totally automated patient s acquisition To update an existing profile select it from the list and click on Modify and then proceed as outlined previously To delete an existing profile select its name and press Erase confirmation is requested prior to erasing Note During patients check in the profiles with analyses not included in the current tray are NOT displayed Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 30 of 31 1 7 CREATING THE CURRENT ANALYSES TRAY Available In Tray Reagents positions Reagent 1 001 7 Big Xx a fi Position Little 90 0 ml Print tests on analyzer 9 Save Cancel
93. R Fig 9 Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver 8 Page 8 of 9 1 3 2 PRELIMINARY CHECKS Before using the analyzer it is recommended to perform the preliminary checks outlined below Some of these checks should be performed daily and others are periodically DESCRIPTIVE TABLE OPERATIVE CONTROL PERIODICITY NOTES Verify that there is sufficient washing solution Daily in the external tank for the needs of the working day The washing solution is prepared by adding to double distilled the Surface Active Agent tensioactive 1ml per liter of water i e ratio 1 1000 See technical specifications regarding double distilled water below Check that the waste containers are empty Daily or that they are of sufficient capacity for at least containing washing solution corresponding to the daily waste liquid volume Zeroing of the photometer Day Wait 20 min from start up Wash the cuvettes with the proper solution Dey Before turning off DOUBLE DISTILLED WATER SPECIFICATIONS Resistivity 25MO Conductivity lt 1uS cm pH 6 4 Residual lons lt 1ug l Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 9 of 9 OPERATOR MANUAL BT 1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER C 1 FUNCTIONS 1 1 Description of the Program Menu Page 1 2 Operating Principles Page 1 2 1 Computations Page 1 2 2 Applied mathe
94. ROL PATIENTCONTROLKNOK PATIENTCONTROLLEVEL PATIENTCLONE PATIENTCUPPOSITION PATIENTNUMBERTEST CHECKSUM ANALYSESCODE Patient Code Patient Name Patient Surname List Group 2 Method Type Urine in 24 h Descriptive Note If the patient is a control If it is a known control Control Level If it is a clone Vial Cup position Number of test Check Sum Analysis Code Identifies Routine or STAT Select only one of these 0 Routine 1 STAT 0 Routine ile STAT Routine STAT ROUTINE Routine STAT STAT 2 Identifies Male Female or Child Select only one of these 0 Male 1 Female 2 Child 0 Male T Female 2 Child M Male F Female 04 Child MAN Male FEMALE Female CHILD Child Identifies Serum or Urine Select only one of these 0 SERUM 1 URINE 0 SERUM i URINE S SERUM U URINE SERUM SERUM URINE URINE Section Chapter 4 Serial Communication BT2000 PL otring otring otring otring Character otring Character otring Character otring otring otring Character String Character otring Character otring Character otring Character otring Character otring Character otring Rev 0 Soft Ver Page 11 of 16 Identifies a Control or a Sample Select only one of these 0 Sample 1 Control 0 Sample T Control N Sample Y Control 9 Sample
95. S NICKS SHARP BENDS PUNCTURES OR OCCLUSIONS BEFORE INSTALLING ON SYSTEM DO NOT TWIST THE PERISTALTIC PUMP TUBING WHEN PLACING IN THE RACEWAY OF THE PUMP ROLLER RELEASE THE PERISTALTIC PUMP TUBING WHENEVER THE SYSTEM IS UNUSED FOR LONG PERIODS OF TIME IF IT IS NOT BE USED FOR SOME TIME THE PINCH VALVES TUBING SHOULD BE RELEASED CAUTION THE HYDRAULIC CIRCUIT SHOULD BE FULLY DISCHARGED AND THE WATER RESERVOIR DISCONNECTED FROM THE CIRCUIT PRIOR TO RELEASING THE TUBES FROM THE PINCH VALVES IF THESE STEPS ARE NOT TAKEN SERIOUS DAMAGE MAY BE CAUSED TO THE ANALYZER THE HALOGEN LAMP MUST BE REPLACED SOME MINUTES AFTER THE INSTRUMENT HAS BEEN TURNED OFF AND POWER CORD UNPLUGGED refer to Chapter N Maintenance ALWAYS ALLOW THE BURNT OUT LAMP TO COOL DOWN BEFORE HANDLING OR ATTEMPTING REPLACEMENT NEVER TOUCH THE LAMP OR THE REFLECTOR WITH BARE FINGERS USE A RAG WHEN CHANGING IF THE LAMP IS TOUCHED INADVERTENTLY DURING INSTALLATION CLEAN THE LAMP OR REFLECTOR WITH ALCOHOL AND DRY WITH A CLEAN SOFT CLOTH BEFORE BURNING CONTAMINATION OF THE LAMP OR REFLECTOR MAY REDUCE LAMP PERFORMANCE Section I Chapter K Warnings amp Precautions 2000 PL Rev 0 Soft Ver 5 Page 4 of 6 30 31 32 33 34 35 36 37 38 39 40 41 42 THIS LAMP EMITS UV ULTRAVIOLET RADIATION PROLONGED EXPOSURE TO THIS LAMP MAY CAUSE SKIN AND EYE IRRITATION THE ANALYZER SYSTEM MUST NOT BE DISMA
96. Secondary parameters 9 Code Sample Starter 01 Bar Code Delay Time 1 Print Test methodology 0_ Reading Time Method az End Point Pme E a w Kind of process m ncubation time with Factor BA S E l 1st Fiter 2nd Fit Tme 1 st Filter nd Filter s Times gt Reagent 1 340 00 g Reaction direction Increasing C Decreasing 5 Copy From Figure 19 Sample Starter This parameter if enabled allows separate dispensation between sample and reagent To enable click on this box to confirm Delay Time Parameter expressed in seconds preceding the incubation time and it indicates a time gap available for the solution in the cuvette to become stable During delay time no reading is performed different from the incubation time and it is useful in tests with incubation time Incubation Time This parameter expressed in seconds indicates incubation time for the analysis reagent and samples dispensed in the cuvettes as required by the methodology The possible values range from 0 to 999 seconds For double reagent methods it is possible to enter different incubation times for the first and second reagent originating in different sampling dynamics During incubation time the analyzer performs reading for capturing in advance the reactions that are out of linearity range see later Check Parameters Reading Time The user mu
97. Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver Page 5 of 22 5 2 SETUP OF THE OPERATING SYSTEM After the restart the system displays the Setup Wizard which will guide the user during setup of the Operating System ows 2000 Professiona E TEP Welcome tothe vindow 2000 T Setup Wizard TEN HE This wizard installs Windows 2000 Professional on your computer The wizard needs to gather some information 1 about you and your computer to set up Windows 2000 properly Click Next to continue with Setup n Click NEXT key to continue with Setup Now the Windows Setup detects the existing hardware and installs devices in the system This will take several minutes In case the system halts crash that means some hardware is not compatible with the system and or the board utilized T Windows 2000 Professional amp Setup E Installing Devices Setup is detecting and installing devices on your computer CAUTION DO NOT INTERRUPT THIS OPERATION Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 6 of 22 Now the Setup asks for setting the correct date and time for the system One may skip this now and set the date amp time later mm 115 1 130117 Setup E TOEI T re sot date After making appropriate corrections click NEXT key The Setup requests to enter Name of instrument and Organization rofessional AME ws
98. T2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 1 1 ABBREVIATED OPERATING INSTRUCTIONS Page 2 1 1 Turning on and preliminary procedures Page 3 1 2 Inserting Reagents for Clinical Chemistry Page 6 1 3 Analytical calibrations and Controls Page 7 1 4 Entering Patients and Work Lists Page 8 1 5 Running Tests Page 11 1 6 Displaying and Printing Results Page 12 1 7 Turning off the analyzer Page 16 FOREWORD This quick guide gives a global view of the system operation by outlining the sequence of fundamental operating phases It is highly recommended to carefully read these instructions and allied information in order to have a deeper knowledge of each argument Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 1 of 16 1 ABBREVIATED OPERATING INSTRUCTIONS The BT2000 PLUS is an automatic analyzer for clinical chemistry and immunochemistry analyses The analyzer can be divided into the following two distinct parts a Sampling Unit It prepares for tests the samples and single or double reagent b Reading Unit Cuvette plate with integral automatic washing system SYMBOLS As the BT2000 PLUS analyzer software runs under Windows it uses the same philosophy with windows icons quick commands function keys and curtain shaped menus Every window has its own icons and specific menus that will be described hereafter The f
99. TENANCE AND CARE 1 1 PREVENTIVE MAINTENANCE AND EXTRA WASH Exercise extreme care to ensure that the system is regularly provided with proper maintenance and care to avoid any problems and malfunctions which can potentially generate erroneous results This will give longest life at lowest overall cost The maintenance is normally performed every six months or whenever the operating conditions dictate it The analyzer stores the number of run tests and a built in maintenance software alarm automatically alerts the operator through on screen messages whenever any part needs attention or replacement Failure to follow proper maintenance and replacement procedures may result in system malfunction EXTRA WASH This function is similar to the one performed daily but it is performed with an aggressive detergent This operation is automatically prompted by the analyzer Place a bottle containing solution of HCI 0 1N in the position 40 of the reagent plate as indicated in the on screen message and activate the washing function At the end perform one or two washings of cuvettes using Wash and fillup function It is highly recommended to perform the Extra Wash whenever there is any uncertainty regarding the execution of normal daily washings A progressive accumulation of contaminants inside the cuvettes may cause serious problems by slowly releasing them during the test runs The following simple steps serve as practical guidelines in establishing yo
100. TION OF THE OPERATING SYSTEM 5 1 Preliminary Phase 5 2 Setup of the Operating System 5 3 Completing the installation 5 4 Settings of the Operating System 5 5 Installation of BT2000 PLUS Program 5 6 Upgrading the BT2000 PLUS software Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 1 of 22 Page Page Page Page Page Page 5 INSTALLATION OF THE OPERATING SYSTEM OS CAUTION INSTALLATION OF THE OPERATING SYSTEM MUST BE DONE BY EXPERT PERSONNEL AND ONLY IN CASE THE OS HAS TO BE RE INSTALLED EX NOVO BEFORE STARTING ANY SOFTWARE INSTALLATION PROCEDURE CONTACT THE AUTHORIZED TECHNICAL PERSONNEL ONLY 5 1 PRELIMINARY PHASE 1 Ensure that the BIOS has the following Boot configuration Hard Disk CD ROM DriveA 2 Check that the mouse and the keyboard are properly connected 3 Ensure that the following supplementary hardware has been correctly installed Additional Serial Audio Card optional Network Interface Card optional Touch Screen Connecting cable between IBM amp 552 4 Turn on the instrument and insert Windows 2000 disk in the CD ROM drive The following screen appears NTER Continue ES C Cancel F3 Quit Press enter to initiate installation Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 2 of 22 Now the screen displays the end user license agreement for Microsoft Windows PORTANT READ CAR
101. TY THE SYSTEM MUST BE GROUNDED THE WIRES IN THE MAINS POWER CORDSET ARE COLORED IN ACCORDANCE WITH THE FOLLOWING CODES GREEN AND YELLOW EARTH BLUE NEUTRAL BROWN LIVE THE WIRE COLORED BLUE IS INTERCHANGEABLE WITH WIRE COLORED BROWN IN CASE OF DOUBTS CONTACT THE NEAREST SALES SERVICE OR A QUALIFIED ELECTRICIAN REPLACE FUSE AS MARKED see Chapter Maintenance PRIOR TO THE REMOVAL OF ANY FUSE TURN POWER OFF AND UNPLUG THE CORDSET FROM THE WALL UNDER NO CIRCUMSTANCES IS THIS INSTRUMENT CASE TO BE OPENED THIS INSTRUMENT IS NOT USER SERVICEABLE DANGEROUS HIGH VOLTAGES INSIDE THIS INSTRUMENT CASE IN EVENT OF DIFFICULTY PLEASE NOTIFY YOUR DEALER FOR PROMPT SERVICE FOR OPERATING SAFETY DO NOT INSTALL THE SYSTEM IN A LOCATION WHERE IT WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS DIRECT SUN LIGHT OR ANY OTHER SOURCE OF EXTREMELY HIGH TEMPERATURES DO NOT OPERATE THE SYSTEM IN THE PRESENCE OF FLAMMABLE FLUIDS OR GASEOUS ATMOSPHERE DISINFECTING AGENTS CLEANING AGENTS ETC DUE TO POSSIBLE FIRE OR EXPLOSION DO NOT KINK BEND LAY OBJECT ON OR OTHERWISE DAMAGE OR RESTRICT CABLES AND TUBES BE SURE THAT THE POWER SWITCH ON THE BACK PANEL OF SYSTEM IS OFF WHEN PLUGGING IN OR REMOVING THE POWER CORDSET FROM A WALL OUTLET TURN OFF THE MAINS POWER SWITCH ON THE REAR PANEL WHENEVER THE SYSTEM IS NOT IN USE THIS PREVENTS DAMAGES DUE TO SURGE IN THE MAINS POWER Section I Chapter K Warnings amp Precautions 2
102. The same function can be performed on demand by activating the Scan Bottle command near the insertion removal commands Whole sector Right click on the SECTOR field Choose between bottle s insertion or removal The analyzer will correctly position the whole sector for insertion or removal With bar code option enabled identification is correctly achieved through the automatic scan of the bar code for the inserted bottles The same function can be performed on demand through Scan Sector near the sector insertion removal commands Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 6 of 16 1 3 ANALYTICAL CALIBRATIONS AND CONTROLS Select Standards Controls Select All Deselect All ch Immediate Standards eh Timed Standards e Immediate Controls xj Timed Controls Fig 6 Select standards Controls Known Unknown Erow Unknown 1 1 1 E Gru 2 2 2 2 Zu all B BO Know Unknow Lj 1 ER BUN 2 2 3 Unknown 1 1 PRO 0 2 2 ry Select All Deselect All Immediate Standards e Timed Standards eu Immediate Controls Timed Controls Ors Fig 7 RUNNING STANDARDS AND CONTROLS The functions Run Standards and Run Controls can be accessed from Tests main menu or through the specific icons that allow direct access Fig 6 and 7 The displayed analysi
103. The analyzer provides two other modes for interrupting its operation 1 SLEEP MODE This mode can be manually activated or it starts automatically when the instrument is left inactive for more than 30 minutes The Sleep Mode automatically performs the wash and fill up of the cuvettes with bi distilled water and remains idle waiting for users commands for immediate operation Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 6 Page 14 of 17 2 LOG OFF The Log Off mode represents a partial turning off of the analyzer It disables some devices Halogen Lamp of the photometer cuvettes thermostat and drive motors This mode is used for energy saving The Log Off mode is utilized for programming automatic turning on at a desired date and time The instrument will remain in a stand by condition and it will automatically turn on 30 minutes before the programmed time The turning on in anticipation 30 minutes before the programmed time allows the analyzer to reach steady state thus allowing immediate operation at the programmed time CAUTION If the SHUT DOWN procedure has not been observed then do not ever stop the analyzer by turning off the main switch 1 7 ACCESS PASSWORD The access passwords have been implemented to activate the various functions procedures of the instrument and in compliance with European normatives regarding privacy safeguarding sensitive data legislative decree No 196 of 30 June 2003
104. XX Known Lot name Lot ohi pu m 21 si Sample position 21 sj Sample position 0 000 Lou value 0 000 Low value 0 000 Theoretical Value o Theoretical Value 0 000 High Value 0 000 High Value Timed re run Timed re run 2 Timed re run Level 1 Level 2 Levell3 Level 3 Level 1 Level 2 Levell3 Level 3 Levelft f Level 2 f Level 3 Level 3 eve 01 08 30 Timed re tun 01 08 30 save Print View used positions used positions Figure 23 Figure 24 Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 25 of 31 The first displayed tables are Level 1 for Known and Unknown controls To select move onto the desired tag title and click to confirm Fig 23 e Known To program move the cursor over desired boxes and confirm Enter Lot name or number mean value and min amp max limits Enter Sample position already set to controls in the section Setup Analyzer included in the inner ring of samples tray e Unknown Enter Lot name or number and Sample position Reserved positions are those already set in the program Setup Analyzer which are shared with known ones e Timed re run With this program it is possible to set automatic controls run for a selected analysis For each control it is possible to enter the time of automatic execution Move over Timed re run field and check the box It
105. a protected place Store the empty wooden crate in a safe place for future use CAUTION The analyzer is provided with four integral handgrips located on the left and right sides of the base frame To lift or move the instrument from one location to another always use the handgrips Arrow Pointing Upwards Base Spring Clip Figure 1 Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 2 of 9 Verification Of the contents of the wooden crates Verify upon receipt of the BT3000 PLUS analyzer system that all parts are present and intact when opening the wooden crates and packaging In the basic package the BT3000 PLUS analyzer system is provided with the following items in the checklist Yv Contents of the large wooden crate Qty Descipion OK 1 ANALYZER 0 o o 1 USER S MANUAL 1 INSTALLATION DISK 1 IMAGE DISK HARD DISK 1 WINDOWS 2000 PROFESSIONAL SOFTWARE DISK WITH LICENSE 1 DRIVERS AND UTILITY DISK oOo 1 J UPSDRIVER 0 1 JPRINTERDRVER 0 1 VGADRIVRDISK gt v Contents of the small wooden crate accessories and peripherals Oty Descipin OK 1 WASTE PROBE HO INTAKE TUBE EB UPS UNIT 1100VA P N 330 2132 1 POWER CORDSET mI 330 6391 1 TRANSPARENT OVERFLOW TUBE 50cm LONG EN CORDLESS KEYBOARD amp MOUSE P N 662 2057 FOR BT2000 PLUS ONLY EN
106. access level password Press New User in the previous screen Manage Users to insert a new user User Name USER Password min amp chr Access Leve Access Patient Archive Cancel 1 Insert user name be already present Here it is not possible to use the combination of identical User Name and Password 2 Insert password minimum 8 characters 3 Repeat password in the Confirm field 4 Assign the initial access level to the user to select a level different from 0 the knowledge of corresponding password is necessary 5 Enable or not Access Patient Archive 6 Click Accept Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 6 Page 17 of 17 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER F 1 QUALITY CONTROLS 1 1 Inserting modifying controls 1 2 Displaying and processing by date 1 3 Displaying and processing by lot pairs Juden graph Westgard Graph Westgard s decision Daily Chart graph Additional Functions Population Analysis Selection How to run a Query Principal statistics formulas used in Population module Diagrams Inserting external analyses Other menu functions 1 6 Patients archive Selection How to run a Query Patient s report Printing Reports Additional menu functions A Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Page Page Page Page Page Pa
107. ation and programming 4 otress program Access to this program is password protected and is for the exclusive use of the service personnel 2 ANALYZER SETUP This command is used for entering additional information on the various controls of the system It can be accessed through the Utility Setup Analyzer in the main menu It is disabled during working sessions of the analyzer By clicking on the Setup Analyzer command a screen displays various programmable items Point the cursor on the desired title and click to confirm After setup is done click Save to save changes or Cancel to leave the program without saving bear in mind that setup is an external program and must be closed once changes are made It is highly recommended that operations in the setup program are performed by specialized personnel Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver S Page 6 of 10 Language this page 1 Figure 7 it is possible to select a desired language e g English or Italian The default language is English To let the analyzer use different language language files must be placed inside the Language directory Analyzer Operative Language Language System Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords Qc 7 Figure 7 System In this page it is possible to modify the f
108. ation s value computation sample Blank B b Blank Reagent with R2 Working Reagent first phase sample blank with reagent 1 and sample data detection at the end of incubation time 1 second phase analysis with reagent 2 and sample data detection at the end of incubation time 2 absorbance delta determination AA between first and second phase and concentration s value computation Only Read Reagent blank Final reaction data detection at the end of programmed time for End Point reading and concentration s value computation End Point Reagent s reading check Data detection during programmed reaction time first 2 points datum in incubation time and the last datum in reading time absorbance delta determination AA and concentration s value computation Without Blank Reagent reading only with reference to H20 Final reaction data detection at the end of programmed time for reading and concentration s value computation However the Blank is read to verify the reagent End Point Absolute During Only Read End Point analyses the analyzer uses the reactive just to prepare the reagent blank The analysis procedure requires then to sample at least 300 ul from the final solution in the sample cups and pour it into the cuvettes for the reading phase Only single reagent use is allowed For the End Point Kinetic Fixed Time Initial Rate and End Point 2 Point methods it is possible to use single a
109. be performed on all the methods One can simultaneously enable the search for one or more groups Group Man Woman Child or Test Type Serum Urine Relation Moreover it is possible to limit search within two dates Date range or according to a given data range Results range Pm Figure 14 Data Sequence adh Stat Histogram Num of Rec Standard Deviation Variance Correlation Coefficient 43 0 736 0 542 0 114 a Mean Variation Coefficient Deviance Median 6 598 11 16 X 22 75 6 500 Prnt Preview After selection of the Analysis Method Group Test Type Results Range and Date Range the graph display page Diagrams DOM Figure 14 is accessed by clicking on Diagrams Figure 13 in the main page The following statistical data for the selected option is presented same as in the preceding main page Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 8 Page 8 of 20 Number of selected records Mean Median Standard Deviation Correlation coefficient Variation coefficient Variance Deviance Clicking on one of the keys corresponding to desired graph in the Diagrams for DOM page Figure 14 it is possible to display one of the following graphs Data sequence displays data sequence indicating on the abscissa the value number and on the ordinates its related value Trender displays data sequence together with minimum square line
110. before applying any maintenance kit Turn on the instrument and perform a washing cycle to evacuate all liquid in the hydraulic circuit When changing tubes pump cartridge etc follow the illustrative diagrams Figure 2 on the next page a Reading Station see Figure 2 Reading Station Peristaltic Pump Tubing Remove both ends of the peristaltic pump tubing from the diluter manifold Squeeze the locking catches and remove the defective cartridge Place the new cartridge on the drive shaft and gently press to snap fit Carefully attach the pump tubing to both fittings in the diluter manifold Pinch valve tubing replacement 1 Detach pinch valve tube and discard it Carefully insert the tube through the perpendicular intake port down into side slot of the pinch valve Pressing of the black button on the front of pinch valve facilitates insertion Carefully attach ends of pinch valve tubing to appropriate fittings as shown in the Reading Station in Figure 2 Washer aspiration tube Detach defective tube and replace with new aspiration tube Washer tube 3 Remove and discard the old tubing It is possible that a small quantity of distilled water will flow out of the water reservoir Immediately dry it after the tube replacement Carefully insert the new tubing into the pinch valve and attach the ends to the appropriate fittings of the water reservoir and the washer Section I Chapter L Maintenance amp Troublesh
111. ber 1 2 3 4 Pos 1 L2 t t t Conc 0 000 0 000 o 000 0 000 aps ooo foo oo aco 100 from last calibration Pin Leg Logit4 git 4 e adjus a D s e Figure 27 Enable the check Re calibrating on single point then enter in the Calibration point the position number occupied by the desired calibrator during the plotting of previous curve Then enter in the Sample position the position on the tray where it should be placed After the determination the analyzer calculates the percentage offset for the current result from the stored value then reprocesses and mathematically updates the remaining ABS values of standards already pertaining to the curve thus normalizing the whole calibration Graph this command displays the graph for the stored interpolation curve In the graphic display page data and curve are displayed together Print This command prints programmed data Save This command saves data and then closes the window Cancel This command exits without saving Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 29 of 31 1 6 CREATING PROFILES J Insert Modify Profile ants Name 151 Available profiles Analyses Code for Bar Code 0 Not Present p si GLU GOT EESE T Ise GGT ALK Figure 28 Figure 29 INSERT MODIFY
112. by the analyzer into final concentration E LI values A text box field appears Figure 25 where it is Number of samples MaxVar possible to enter the known factor reported in the ho 2 aime methodology while the ABS value of reagent detected by FIN repicates oovon00 Treset the analyzer is represented contextually m Linear Range limit Factor and acceptable Limit A parameter for conversion of absorbance values ABS determined by the analyzer into the final values of the number 1 2 4 concentration Enter the factor value if known or else leave the displayed value because the analyzer after each cone 5 000 po calibration calculates and updates the data In order to Lgs foo verify calibration s validity enter the Minimum and rT Maximum range in which the calculated factor must be A hda included After the determination of an out of limit value a Vewuedpose Linear Cen message informs the user and the previously stored value Queen um is not modified If the values for concentration and m aaa D s absorbance are known it is possible to process mathematically the factor through the Calculation Figure 25 command Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 26 of 31 Timed re run standardization time Using this parameter it i
113. ct the test and click on Print preview All results matching with the search criteria are displayed Select Print out from here it is possible to print patients results corresponding to the search criteria Complete Report with preview this option will allow Print Selection Complete Report with preview Complete Report Quick Print C Records Selected Quick Print x 9 Cancel printing of all patients reports matching with the search criteria A printing preview will be displayed Complete Report Quick print this option will allow printing of all patients reports matching with the search criteria Printing is immediate with no preview Records Selected Quick print if only one or a few patients are selected it will be possible from here to print only these reports These three kinds of printings will produce reports as shown in Fig 32 Section I Chapter F Quality Controls BT2000 PL Rev 0 Soft Ver S Page 18 of 20 Patients Archive Code 0006209 Male Test Date 03 03 03 Surname Barnard Name Paolo Notes Questa amp una nota abbastanza lunga Analysis Method Result Result 2nd Range Range end islucasia Trinder j 90 33 22 00 53 00 RAT Trinder 75 90 mgidl s4 00 114 0 colesterolo Color BO 63 mgidl 40 00 118 0 FAC 27 02 mu dl 10 00 34 00 Bilirubina Jundrassik 94 58 Ud 35 00 89 00 Glicemia Trinder Mm 11 07 mal
114. d Halogen dichroic lamp 12 VDC 35 Watts Life hours Approximately 2000 hours NOTE For optimal result the lamp can be used for about 1 500 hours The long term use will result in the gradual deterioration of the UV emission Section I Chapter D Performance and Limits Rev 0 Soft Ver 8 BT2000PL Page20f3 DILUTER TECHNICAL SPECIFICATIONS Diluters Type Biotecnica Diluter Module Max Volume 470 ul Linearity 0 1 full scale Accuracy at 3 ul 3 Accuracy from 10 to 470 ul 1 Reproducibility 0 7 at3 ul 0 6 gt Life Expectancy 3 million operating cycles Maintenance every 300 000 operating cycles O ring seal replacement VOLUMES WORKING SOLUTIONS Clinical Chemistry Reaction Volume 280 ul min to 700 ul max double reagent Sample Volume 1 to 100 ul RESIDUAL VOLUMES FOR REAGENT BOTTLES 50 ml BOTTLES Approx 1 ml 20 ml BOTTLES Approx 0 5 ml 10 ml BOTTLES Approx 0 5 ml RUNNING TIMES FOR UTILITY approximate Wash amp Fill Up 2 0 seconds approximately Wash H20 180 seconds approximately Zeroing 420 seconds approximately FOG 900 seconds approximately Extra wash cuvette 540 seconds approximately Wash Shut Down 12 minutes approximately WASHES VOLUMES Clinical Chemistry Washes H20 single wash of cuvette 5 ml approximately H O Single wash of Needle 2 ml approximately Consumption per test 7 ml approximately H20 for zeroing 250 ml approximately
115. d as described in Routine but if sent for execution they are analyzed immediately with highest priority All the acquired patients with no assigned position are saved and displayed in the temporary list Extra Patients STAT from where they can be transferred back to the work list on user s demand refer to paragraph 1 5 Work Lists Patients Tes Utility New Entry Gog B 8 E Routine STAT Control Standard Extra Patients STAT Options Options analyses Figure 8 New Entry Controls Once the icon Controls is selected the list of control positions is displayed Fig 9 Controls acquisition frame is displayed by activating New Entry command or with a double click on a given position A window identical to the one displayed in Routine appears but without the patient fields Bear in mind that the tray positions reserved for controls are the ones assigned in the Analyzer Setup Chapter H paragraph 2 An appropriate screen message alerts the user when a wrong position number is entered Patients acquired as Controls can be saved as described in Routine and are executed afterwards All the acquired controls without assigned position are saved and displayed in the temporary list Extra Patients Control from where they can be transferred on user s demand refer to paragraph 1 5 Work Lists Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page
116. d by the factor computed during calibration to obtain the concentration of the analyte in the sample Conc in sample Factor x A3 Reagent Blank A2 A3 A DELAY TIME INCUBATION READING TIME TIME Absolute End Point This method is identical to the End Point but without subtraction of the Reagent Blank Fixed Time In this type of reaction there is an increase or decrease of the absorbance during both incubation s and reading s phases However the slope of the line may not be the same during the two phases The reaction graph displayed to the user is not always linear but can also appear as piecewise linear This is because the graph is obtained by the union of the read points that may not be aligned A regression line is calculated during both incubation s and reading s phases These provide the user with information about the correct evolution of the reaction During reading time the absorbance delta AA is also computed which is used for calculating the final concentration for the analyte in the sample It may happen due to a physical delay that the instrument does not respect the timing and that tests are read at a different final time from the one set in the parameters In this case the analyzer performs one more reading traces the regression line between the last two points moves to the exact reading time and derives the correct absorbance value from it Concentration is calculated by multiplying the absorbance d
117. d to H2O intake discharge of waste fluids and a connector for transparent fluid overflow tube A transparent tube supplies double distilled water from the external container The waste probe tube discharges the analyzer waste flowing from an internal vacuum pump to the external waste container In addition the tubes are fitted with quick connects having built in shut off valves which in case of disconnection prevents liquid spillage Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver 8 Page 6 of 9 Overflow Tube Fisher connector Waste Probe Waste Probe H O Intake Fig 7 The transparent tube double distilled H20 plus Surface Active Agent i e tensioactive 1ml every liter of water ratio 1 1000 must be connected to the right connector H20 Intake Its other end goes to the external water container Connect the liquid level detector cable Fisher connector and the drain tube of the waste probe to the middle connector Waste Probe Insert the waste probe in authorized external waste container Refer to Figure 7 WARNING 1 Do not use the internal vacuum pump system with any other fluid source except the BT2000 PLUS analyzer The unauthorized use may result in serious injury to the user and permanent damage to the vacuum pump system DRAIN TUBE CONNECTOR WASTE PROBE P N 07 05165 01 Figure 3 1 3 STARTING THE INSTRUMENT 1 3 1 TURNING ON THE INSTRUMENT FOR THE FIRST TIME Tur
118. displays the following commands Send to extra patients The selected patients are removed from current samples tray list for placement on Extra Patients List Selection can be done by checking the appropriate boxes Use Select to select the whole list and Deselect All to deselect it but in this case confirmation is required Options Print send to extra patients Prints the partial for selected items or total samples list Print d Select Al Select All Deselect Al Automatically selects the whole list Run Delete Deselect All Automatically deselects the whole list confirmation required Scan tray d Scan tray and run d Run Work start command If single patients or the whole list is selected a message asks if the samples have been inserted If the answer is affirmative the analyzer automatically starts processing In case of a negative answer a guided procedure will assist the user to insert the samples The selection of the sample to be inserted is performed by confirming with cursor on the check box After the insertion of all the samples activate Run Delete Removes selected or all the patients Confirmation is required NOTE In case the serum barcode is enabled in the Options menu then two additional commands are automatically added Controls are excluded The two commands are Scan Tray and Scan Tray and Run Both commands allow further select
119. dology In this field the reaction principle used for the test can be specified for example Jaff IFCC etc This option is useful when recalling the tests from the QUALITY CONTROL archive in accordance with different principles during the function Data Processing Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 17 of 31 Method This parameter defines the main methodology for the analysis To program move the cursor over and select the chosen method The available methods are detailed in paragraph 1 2 5 of this chapter Parameters for Clinical Chemistry GLU Code Trinder Method Primary parameters Check Parameters Secondary parameters GLU Bar Code Test methodology End Point Reagents E Kind of process Sampl Eo Linear 9 Sample With Factor Polynomial Cubic Spline Multi Points Log Logit 4 Log Loait 5 Least Curve 2 Limes E lel Copy From Figure 12 Kind of process defines the kind of test s calibration linear with factor or with curve The following choices are available Parameters for Clinical Chemistry GLU lable Methods Fig 1 3 Primary parameters Check Parameters Secondary parameters Code End Point GLU BarCode E p Kinetic Test methodology Fixed Time Trinder Method Initial Rate I R lendron 2 IEEE sample Blank type A Kinetic Fited Time In
120. e and click NEXT NOTE The ensuing procedure will remove only the executable files but not the data A screen Confirm File Deletion appears InstallShield Wizard Welcome T Modify repair or remove the program Welcome to the bt Plus Setup Maintenance program This prdgramilets you modify the curent installation Click one of the options below SOUPE C Confirm File Deletion Internet Explorer P Remove a Remove all installed components Connect to the Internet InstallShield tart te E 7 Wizard Click Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 21 of 22 Wait for the completion of the procedure My Computer u Maintenance Complete My Network l InstallShield Wizard has finished performing maintenance ope o J lu laces d perations on bt F Recycle Bin t annm enn Internet Explorer Connect to the Internet starl rA c LL PTrostanishield wizard Q EL 9 Now click Finish Now a screen with various options for End installation with restart or without restart of the system is displayed Select the second option No I will restart my computer later no reboot My Computer Taq 3 DUE T End installation My Network Places Setup has completed installing bt Plu Recycle Bin i Yes
121. e accessed from Patients main menu or from dedicated icons Select Exit to leave the program The represented analyses codes pertain to the list generated in the Create current tray Insert Routine STAT The following options are available in this page Global Insert View Patients Figure 5 ee B d E E Re un Routine STAT Control Standard Exit New Entry Extra Patients Routine ions Options E Ld d d ff di di di Wi A mi Fa 3 5 El 13 15 17 19 21 23 25 27 23 31 33 35 37 39 AL NN wq i i e c D Q NOTE Point the cursor on the desired option and click to confirm Re run allows tests re run repetitions on user s demand Routine Default display of Patient positions STAT Displays STAT Single Test in Actual Time i e urgent positions positions Control Displays Control positions Standard Displays Calibrator positions New Entry Enables data entry procedure for Routine STAT and Controls Extra Patients Displays the list of patients with no assigned position Patients selected in the work list may be moved here Options menu Send to extra patients command and then back New Entry Routine After the selection of Routine followed by confirmation through command New Entry the patients acquisition frame is displayed Figure 6 The
122. e 20 Figure 21 Select the Check Parameters table Fig 20 and 21 To set a given parameter move the cursor on its corresponding textbox and click to confirm The user can enter the following information Reagent limit mABS this parameter indicates the limit absorbance ABS value that is acceptable for the reagent maximum for increasing reactions minimum for decreasing ones and it is expressed in mABS If reagent s absorbance is beyond this limit the analyzer will check the results with O flag Reactive out of limit This parameter allows monitoring reagents quality as well as checking any variation from the specific techniques The parameter is identical for the serum and urine Note This control has the highest priority on all the other check flags and inhibits the automatic repetition functions Curve Acceptance C C Correlation Coefficient The programmable values range from 0 to 100 This parameter is identical for both serum and urine and indicates the acceptability limit for any data instability that is detected during programmed reading time If this value is exceeded the final result will be checked with a flag Unstable Sample C C greater than assigned value Test limit Conc This parameter is used in all methodologies and it allows verification of the final concentration of the analyses It represents a threshold value beyond which the analyzer detects an out of linea
123. e compound in the sample and the any irregularities found in the reaction The general principle upon which the photometry in clinical chemistry is based is the following the increasing or the decreasing of the color intensity in a specific solution is proportional to the searched compound concentration Generally speaking when a sample is added to a specific reagent it starts a reaction carried out by specific enzymes or substrates This reaction causes the increasing or decreasing of the solution color inside the cuvette During the reaction process the instrument reads it by means of its absorbance The final data processing is done with reference to a calibration or a theoretical factor so as to give at the end the concentration of the compound into the sample 3 SYMBOLS EXPLANATION OF THE USED OR APPLIED SYMBOLS As the BT2000 PLUS analyzer software is based upon Windows it uses the Windows style icons quick commands function keys and curtain shaped menus Every screen has its own icons and specific menus that will be described hereafter The full meaning of each command will be explained in the corresponding chapters At the start up the program will display the following main window Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 3 of 11 Patients Tests Analyzer Utility External Programs OG 06 008 0 02000 Insert Routine STAT Insert Batch Run all pending
124. e end of working sessions After confirming the command and selection of the desired analysis two data re processing modes are available The first mode allows a positive or negative percentage correction and the second mode uses the latest valid calibration This function is password protected see Chapter C paragraph 1 5 Archive Data This command saves data into the patients archive Delete results This command deletes data It is password protected Exit Exits from data display page Section I Chapter G Displaying and Printing Results BT2000 PL Rev 0 Soft Ver 6 Page 3 of 7 1 2 RESULTS PER TEST fi 523000 Iet e 9 CTRL6T24 _ mg dl 5 03 43 0 102 3 0009457 80 0 mg L 6 93 35 0 96 5 GLI Glicemia Inserisci 51 0002151 mg L 7 01 11 0 55 5 Routine STAT 9 CTRL6724 31 9 ug L 8 86 27 0 82 5 1 3 0009457 72 4 mg dl 5 75 20 0 46 0 Inserisci Batch V GLU Glucosio Esecuzione 5 CTRL5496 52 4 ng dl 5 35 pazienti in attesa 9 CTRL6724 87 1 mg dl 4 21 14 0 54 0 EN H3 0009457 46 4 mg dl 0 670 19 0 65 5 1 Ripetizione per 7 CTRL4251 64 5 UI dl 4 94 1 analisi V LIP Lipasi Cancella lista ponant 51 0002151 50 7 mg dl 9 95 26 0 68 0 3 0009452 aaan UI l i 3 37 33 0 91 5 PRY 51 0002151 19 3 UI dl 9 41 10 0 71 0 1 9 CTRL6724
125. e following 9 elements set 1 2 2 17 21 34 34 34 67 X 9 1 2 21 median is 21 the fifth element The median for even elements is the X N 2 X N 2 2 V2 element Ex be given the following 8 elements set 1 2 12 24 26 45 45 46 UX 4 X 5 V2 24 26 2 25 median is 25 By comparing the median and the arithmatical mean one can assume the existence of a measurement error or an asymmetry in the distribution function in case these two quantities differ greatly Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 10 of 20 by double clicking the information about its its coordinates information about J Rev 0 Soft Ver 6 Page 11 of 20 Data Sequence Graph DIAGRAMS position and value is shown Stat Histogram Print Preview Exit Trender L J Histogram LJ kals asl Histogram Stat Histogram Print Preview Data Sequence i O c fe amp gt mouse on a given plotted point coordinates By clicking on Data Sequence Fig 15 key the data sequence is displayed iz O T 5 3 5 ow T Os Zu n D 8 8 Lo Lo Ds SU C e I Lo X miu o c mn 8 LL iei 5 D c pal e oO P c c i 5 O 3 A a c mm c zt 2 E
126. e samples tray Keep in mind that enumeration is the one set in the program Analyzer Setup paragraph 2 Chapter H It is possible to use up to 4 different standard concentrations or run up to 4 repetitions on a single title and position in the linear analyses It is also possible to assign the same positions to several analyses when using multi calibrators Programming several standards Enter the number of standards to be used in the Number of samples textbox up to 4 samples The programmable fields for positions Pos and the concentration values Conc for the selected number of standards are then automatically displayed In the ABS boxes the values are automatically updated during the calibration if Known then the operator can insert them Move cursor to each textbox field to be programmed and click to confirm and then enter data Figure 26 Programming replicates on a single title Enter 1 into the Number of samples field then enter the replicates up to 4 max The position default position is n 1 as well as standard s concentration is automatically displayed together with other read only fields equivalent to the number of replicates entered The values are automatically updated in the ABS boxes during the calibration if Known then these can be inserted by the operator Move cursor to each textbox field to be programmed and click to confirm and then enter data Figure 25 Section I Chapt
127. echnical assistance IMPORTANT NOTICE The above mentioned messages are only a partial representation of all the possible warnings that the analyzer may output to the user In case of any unknown messages please contact Technical Assistance Dept at Biotecnica Instruments S p A giving detailed description of the type of error and possibly the conditions of the event Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver 8 Page 12 of 12 OPERATOR MANUAL BT1000 amp BT2000PLUS SECTION I GENERAL INFORMATION CHAPTER M 1 TECHNICAL SPECIFICATONS Page 2 NOTE This manual is valid for both BT1000 and BT 2000PLUS The following components are not installed on the BT1000 a Reagent refrigerator b Barcode c Touchscreen d Cordless Keyboard amp Mouse NOTE Specifications are subject to change without notice Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter M Technical Specs 2000 PL Rev 0 Soft Ver 8 Index 1 TECHNICAL SPECIFICATIONS PERFORMANCE Operating Mode Random access Methods Tests for Clinical Chemistry and Immune Chemistry Test Mode Routine Batch Emergencies STAT Profiles Tests on line 48 refrigerated reagents Relation Tests Tests in memory 500 single or double reagent unlimited Relation Tests Test Re runs automatic or on demand Calibrations and Controls automatic or on demand Automatic Profiles automatic execution
128. ecution are highlighted in red free positions in green while the programmed samples in Stand By state are indicated in blue If there is lack of serum or reagent the samples are highlighted in yellow Patients codes that are cloned are written in italics while the determinations that are currently being repeated are underlined The absence of results is in white color and the yellow color is used for processed data The Samples in Extra Patients Routine list and the Re run list are displayed in blue The font color and style of patient codes have the same codification as the list of sample tray Work Lists are used to display the entered patients codes or to verify the samples state on the tray Fig 11 together with the situation for Routines STAT Controls and Calibrators Routine Tray List Inside this list it is possible to view in real time the actual situation The user by double clicking on an active position enables the Registry situation with information on selected code and analyses It is possible to modify if the sample is not being run It is possible to enter new data by just double clicking on a vacant position During tray processing as the samples are analyzed the positions that were previously occupied become vacant green Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 8 Page 11 of 17 Options The Options menu is available in the Current Tray Routine STAT and Controls It
129. edical devices 1998 EN 980 1996 Graphical symbols for use in the labelling of medical devices Section Chapter 7 Bibliographical Reference BT2000 PL Rev 0 Soft Ver 8 Page 2 of 2 OPERATOR MANUAL BT1000 BT2000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 8 8 LIST OF APPLICATIVE METHODOLOGIES Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section Chapter 8 List of Applicative Methodologies BT2000 PL Rev 0 Soft Ver 8 Page l of 2 8 LIST OF APPLICATIVE METHODOLOGIES All available applicative methodologies are resident in the analyzer s hard disk Section IT Chapter 8 List of Applicative Methodologies BT2000 PL Rev 0 Soft Ver 8 Page 2 of 2
130. ee Figure 3 4 amp 5 2 ED aae iu Mn ult ji z Sue Lae d 3 XE Sey RE i 3 Figure3 Figure 4 1 ii Td Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver S Page 5 of 12 REPLACING THE HALOGEN LAMP Figure 5 Precautions for handling the halogen lamp Turn off power and remove the power cord from the wall outlet before servicing The replacement of the Halogen lamp can be done by the removal of the rear panel or by sliding the transparent shutter on the front panel and then removing the access cover from the deck Figures 3 4 amp 5 Always allow the burnt out lamp to cool down Never touch the reflector or the lamp with bare fingers Use a rag when changing If the lamp is touched inadvertently during installation clean the lamp or reflector with alcohol and dry with a clean soft cloth before burning Contamination of the lamp or reflector may reduce lamp performance It is recommended to initially burn the new lamp for about 30 minutes before analyzer operation Release the lamp assembly by gently sliding downwards Loosen the front screws in the socket and remove the burnt out lamp Insert a new halogen lamp fully into the socket and firmly tighten the screws to secure the lamp It is recommended to slightly press both of the lamps retaining spring clips before fitting the lamp Slide the lamp assembly onto the li
131. elta during reading time by the factor obtained from the calibration Conc In Sample Factor x A3 A2 A2 AA Al A2 A3 Al A2 A3 DELAY TIME TIME READING TIME INCUBATION DELAY TIME READING TIME Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 10 of 31 Kinetics This kind of reaction is very similar to the previous one with the difference that the reaction and the graph derive both from the computation of two regression lines one for the incubation phase and the other for the reading phase These two lines are often the same if the reaction has a good quality The regression line for the reading phase is then scaled to minutes to compute absorbance delta AA min This value is then multiplied by the factor to compute the concentration of the analyte in the sample Conc in Sample Factor A3 A2 A3 A2 AA min Al A2 A3 AI A2 A3 DELAY TIME wee READING TIME DELAY TIME here READING TIME Initial Rate I R This type of reaction is very similar to the kinetic one If the initial phase is stable then it behaves exactly like a kinetic reaction If the initial phase in unstable the regression line is computed by eliminating the points outlying it from 49 to 100 Thus the calculation is identical to the one for kinetic reaction Conc in sample Factor x AA min Sample Blank A This method is used whenever it is required to eliminate the photometric
132. end a special character with values less than 32 or higher than 124 it is necessary to keep pressed the ALT key and simultaneously to write the value of the character to be sent using numerical keys For example to send EOT it is necessary to keep the ALT key pressed and simultaneously enter the value 4 through the numerical key and then release the ALT key Program BTPLUS EXE It is a simple communication program that simulates the host computer At the start it is necessary to identify the number of communication port from 1 to 4 and the desired procedure Transmission or Reception In case the Transmission is selected the program will ask for patient code from 1 to 15 characters the test number from 1 to 9 and the relevant analysis code for each test for example BUN It is a good practice to use the same analysis codes which the analyzer has memorized in the plate actually in use if otherwise then an error will result in the transmission phase Now the program will execute an initialization procedure of communication with the analyzer will send patient data and wait for the outcome of transmission At the end the screen will display the outcome of the operation or show the position number of the plate where the patient has been inserted or explanation of error code sent by the instrument for example Patient Code Duplicated Section Chapter 4 Serial Communication BT2000PL Rev 0 Soft Ver 8 Page 15 of 16 If the Reception
133. ent in the current reagent tray 1 3 3 PRIMARY ANALYTICAL PARAMETERS From the page All Tests or Current Tray select the desired test code then move mouse cursor over Parameters and click to confirm In the displayed page the analytical parameters for the chosen test are shown they are divided into Primary Parameters Secondary Parameters and Check Parameters By clicking on the gt or buttons it will be possible to go to the next or previous test parameters Parameters for Clinical Chemistry GLU The first screen shows Primary Parameters to display the other screens click on the corresponding tags Primary Parameters Parameters for Clinical Chemistry GLU Code The code of the selected Ronee Be Number of reagents amp Save analysis IS shown in the text box It BLU Barcode O is not possible to write in this field Test methodblogs Bar Code t is possible to Trinder Volume pl 300 Method assign a numerical code for L Concentrated End Point gt BUE us i i Kind of process Dilution vith water positive barcode identification It NE enables if activated the Setup po ECOSSE ale Analyzer bar code scanning to eaction direction i correctly identify the bottle during reagent s insertion phase Decreasing Tey Copy From Figure 11 Test metho
134. ent refrigerator b Barcode c Touchscreen d Cordless Keyboard amp Mouse Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Index oh a o00oooN 1 INTRODUCTION The BT2000 PLUS is an automatic analyzer for Clinical Chemistry and Immunoturbidimetry represents the technological evolution of the T A R G A line Technology Advanced Random Generation Analyzer manufactured by Biotecnica Instruments S p A Rome Italy The BT2000 PLUS software is based upon Windows 2000 NT Fig 1 It is easy to learn and offers the operator thanks to its selective random access the maximum flexibility in the acquisition and performing of ROUTINE and URGENT Single Test Actual Time tests on serum plasma and urine Designed for continuous use 24 hours non stop the analyzer can perform STANDARDS CALIBRATION and QUALITY CONTROLS upon operator s request or at programmed time intervals An AUTODIAGNOSTIC FUNCTION is built into the operative software continuously monitors the analyzer system for correct operation The analytical throughput is 330 tests h for clinical chemistry The methods used are End Point Fixed Time Kinetic Initial Rate I R Sample Blank type A and B Only Read End Point 2 points Sample Blank A b Sample Blank B b and End Point Starter It is possible to store up to 500 different test codes plu
135. ents S p A is thus responsible for providing to the customer clear and effective information for use of it s products including all the precautions and warnings for a secure and risk free use e Service personnel must also refer to the warnings and cautions notices in this manual It is the duty of the service engineer of Biotecnica to instruct his service personnel to take all necessary precautions during repair and handling of products e Biotecnica Instruments S p A is not responsible for any damage that may be caused directly or indirectly to persons or things due to a lack of observance of all the warnings and cautions outlined in the user s manual and concerning the warnings and cautions during the different working phases of the instrument see chap M Direct indirect incidental special moral damages as well as other damages of any type including with no limitation those deriving from profits loss business interruption or information loss cannot be ascribed to Biotecnica Instruments S p A even in the case in which the possibility of the event had been explicitly stated Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Tel 39 06 4112316 Fax 39 06 4103079 E mail bt biotecnica it Web www biotecnica it Section IT Chapter 2 Warranty Conditions BT2000 PL Rev 0 Soft Ver 8 Page 2 of 4 NOTES FROM THE MANUFACTURER gt The Biotecnica Instruments S p A reserves the right to revise this manual without
136. er C Functions BT2000 PL Rev 0 Soft Ver 8 Page 27 of 31 Var Maximum percentage variation This parameter is for verifying percentage variation It represents the acceptable difference between the ABS values calculated for the different calibration points in case more calibrators are used or repetitions are performed on a single title When an out of limit variation occurs a message alerts the user and the calibration will not be stored the previous positive calibration will remain in memory Reagent mABS It is a read only field a function common to all the analyses and it is updated every time the blank reagent is performed In case Dynamic Blank is enabled subtraction of the photometric variation of the reagent refer to paragraph 1 3 3 Primary Analytical Parameters then the reagent ABS value and the variation detected during blank s reading are displayed from last calibration It is a percentage check made between current and previous calibration It compares the newly determined ABS data with already stored data If the programmed limit is surpassed then a message informs the user and the previous positive calibration will remain intact in memory View used positions This command opens a unique window to represent tests disposition Automatic adjust It is a password protected parameter that enables or disables automatic modification of test results in case of an additional calibratio
137. erator during input The group pertinence is indicated see Chapter F paragraph 1 Quality Controls c Surname Name Patient s personal data d Sample Type The relationship of Sample to one of the groups Routine STAT CTRL or STD is indicated between brackets e Results Tests results for a given patient are displayed indicating extended name of the analysis test methodology normal values range and any eventual warning flags see Section Chapter G paragraph 1 5 Flags List For automatic repetitions the values for the first and second determination are shown Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 15 of 16 The following commands are available in the Real Time data display page Print It provides hard copy of the entire contents of the Real Time data display page Exit Exits from Real Time data display page 1 7 TURNING OFF THE ANALYZER To turn off the instrument the SHUT DOWN procedure must be observed In this way the instrument is turned off not completely except for the reagent refrigerator The shut down procedure proposes the wash of the cuvettes with appropriate washing solution before turning off The analyzer indicates the position where the detergent should be inserted for the cuvettes washing see also Chapter C paragraph 1 1 There are two additional modes for interrupting analyzer operation 1 SLEEP MODE This mode can
138. erformed by the instrument This software module is independent from the operating program for analyses performed by the instrument The main functions are Display and data acquisition from updated analyses file Update internal archives Delete analyses files Generate dynamic query that allows to sort and display data by analysis analytical method results range group type and date Statistical operations display number of run tests mean calculation standard deviation variation amp correlation coefficients variance deviance angular coefficient and known term of the minimum square line Display data graphs Trender data with fitting line L Jannings histograms with base zero and statistical mean value represents the base Printout of total and partial data graphs and statistics Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 8 Page 7 of 20 Moreover the program has the following built in secondary functions Total and partial Back Up and Restore selected by date and or group and or type and or method and or by results range functions Total Restore function appends adds data to the existing archive Printer setup Deletion of the whole population archive Addition of external tests for storing in the memory results belonging to different analyses than those performed by the analyzer these results will be saved in the archive thus allowing data display
139. ero positioning of the reagent tray This error can be ERROR RESETTING caused either by an incorrect placement of reagents REAGENT TRAY tray into the analyzer or by a defective position sensor Verify and correctly place the reagents tray and then press F5 Reset key to restore correct analyzer operation In case of defective position sensor contact qualified technical assistance to solve the problem This message stops the execution of programmed tests The message ERROR RESETTING DILUTOR is generated by incorrect zero positioning of the dilutor piston This error can be ERROR RESETTING caused either by an excessive piston friction or a DILUTOR defective position sensor In the event of friction it is sufficient to disassemble and clean the piston with a soft cloth dampened with alcohol reassemble and then press F5 Reset key to restore correct analyzer operation In case of defective position sensor contact approved technical assistance to solve the problem This message stops the execution of programmed tests A position sensor error of the cuvette tray ERROR RESETTING generates the message ERROR RESETTING CUVETTE TRAY CUVETTES TRAY Press F5 Reset key to try to restore the correct operation of the analyzer If this does not solve the problem then it will be necessary the to contact approved technical assistance Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0
140. error codes description and the possible causes Error Code Possible Causes An invalid command has been inserted in the Unknown command commands of script Ane vsus A string as first parameter for String or Stringn g req command has not been inserted A string like parameter lt lunghezza gt of command Stringn has been inserted 1 2 3 A number request 04 Invalid number format Inserted invalid decimal or hexadecimal number a Inserted more than two parameters for command String or Stringn Cala b Inserted more than one parameter for the command Char or Set A string for command Char has been inserted 7 String Terminator Request a Inserted less than two parameters for command String or Stringn b No parameter inserted for command Char or Set Invalid String Length The string length for Stringn command is less than 0 or more than 128 a An empty string inserted for the command String or Stringn b Inserted a character identified as a Tried to transfer an invalid variable in the list of internal variables b Tried to use a transmission variable in the script of reception or vice versa Damaged file Hard disk error Contact Sales Service Internal error Probably damaged program Reinstall Unknown file the program If the problem persists contact sales service a The text SET BEGIN or SET END not written Incorrect identifier the b A different value from ANALYSEDATA SET comma
141. es in order to bring the reaction into linearity range The final result is automatically multiplied by the dilution factor and will be checked with A flag Hyperactive Sample out of final ABS Limit Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 22 of 31 Max ABS Delta mABS This parameter expressed in mABS is used in all the methods except Only Reading It represents the maximum Delta A for the reaction detected during incubation phase Test is considered out of linearity when this value is surpassed For the methods Kinetics Fixed Time and Initial Rate the analyzer processes data using the obtained result till the end of test s reading phase This ABS Delta is compared with the set value For kinetics this value is scaled to minutes for the methods End Point End Point 2 point Sample Blank A B Sample Blank A b Sample Blank B b and End Point Starter the analyzer checks ABS variation produced by the reaction at 74 of incubation time and if this value is surpassed the test will result in out of linearity condition With the Re run hyperactive check enabled refer to paragraph 1 3 6 Automatic Re runs the analyzer will automatically re run the test by pre diluting the sample see Samples in order to reenter the reaction into linearity range The final result is automatically multiplied by the dilution factor and will be checked with flag Hyperac
142. for a rapid access to the most frequently used commands refer to Chapter A paragraph 3 The analyzer provides access to the operating commands in the following three different ways Menus Shortcuts Icons Menu move the cursor on the selected command and click once to access the function Shortcuts the shortcut is a particular combination of the keys Ctrl or Alt one letter of the function s name ex Ctrl P or Alt A It gives a direct access to the requested command The Shortcuts are available for the menu items in Patients and Tests These are always enabled except for the external programs the diagnostic page and the parameters programming pages or in case of errors notification Icons it is the symbolic representation of a given function Move the mouse cursor on the desired icon and confirm by a single click to access the function The menus contain five items Patients Tests Analyzer Utility and External programs Each item has a sub menu that provides access to additional commands some of which can also be selected through combination of keys corresponding to the desired shortcut Patients Menu Fig 1 Insert Routine STAT Insert Batch these items are used to enter samples for Routine STAT and Batch mode Insert Rautine STAT Ctrl P all pending patients Restarts the work list after an interruption Patients Tests Analyzer Utility Ex Insert Batch
143. for transferring data from the analyzer to the host computer Data transfer can be automatic if enabled in the Setup If it is not enabled then the data transfer occurs on user s request through the command Accept Result to be sent Confirmation is required The function Delete Result to be sent always present allows deletion of the data to be sent to the host computer confirmation is required see also Chapter H paragraph 2 Analyzer Setup Clear Patients List This command allows deletion of the previously acquired patients list Confirmation is required It deletes the whole list Standards Activation of Standard button displays a list Fig 13 of Calibrator Positions Current Tray Standards This list is in a read only format A double click on an active position displays the assigned analyses codes Patients Tes Utility ALI L1 ex AAAA ES wo im im m n ln un n 7 F 03 02 10 20 31 a C mBar Figure 13 1 6 TURNING OFF PROCEDURE To turn off the instrument the SHUT DOWN procedure must be performed In this way the instrument is definitely turned off except for the refrigerator for the reagents The shut down procedure proposes the wash of the cuvettes with appropriate washing solutions before turning off The analyzer indicates the position where the detergent should be inserted for the cuvettes washing see also Chapter C paragraph 1 1
144. ft Ver S Page 20 of 20 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER G 1 DISPLAYING AND PRINTING RESULTS 1 1 Results per Patient 1 2 Results per Test 1 3 Displaying Real Time data 1 4 Reaction graphs 1 5 Flags list Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter G Displaying and Printing Results BT2000 PL Page Page Page Page Page Page Rev 0 Soft Ver S8 Index Jo Om 1 DISPLAYING AND PRINTING RESULTS The representation of the test results can be accessed through the specific icon shown on the right for the two available options View results for sample results will be displayed for patient and View results for test results will be displayed for test 1 1 RESULTS PER PATIENT Results aMWwuaa NN t gt 7 CTRL9413 Lanti David Control Unknown Level 2 Lipasi lt Trinder gt 6 66 UI l 8 47 llicemia lt Color gt 94 9 mg dl i 2 90 Fac lt Trinder gt dd UI dl i 3 60 VED ADR 43 2 ng dl i 5 18 RAT lt Color gt 58 0 UI dl d 28 Bilirubina CNN 24 4 UI dl i 8 08 PRV lt Color gt leat UI dl i 1 56 BID CNN Sos 1 i 0 890 Glucosio TROS 39 9 mg Adl i 2 33 Colesterolo Da 1H UIZl dada D H5 0003894 Claro David STAT Glucosio lt Color gt 26 1 UI dl Bla 51 0 e 115 Lipasi lt Trinder gt 41 6 ng dl i 1 55 33 0 6l 5
145. ge Page Page Page Page Page Page Page Page Page Page Page Page Page Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver S Index OG PR BP ONN 1 QUALITY CONTROLS It is an external program for inserting modifying and processing quality controls Version 2 0 14 12 2001 11 36 18 Fig 1 It allows to Insert Modify controls Display and process by date Display and process by lot pares Additional functions 1 1 INSERTING MODIFYING CONTROLS After selection of key parameters such as Analyses Lot Method Type type of control Known Unknown and Level one must set the Value Value in concentration In case of insertion of new Lot the program will request its range valid only for Known control See Figure 2 Insert Modifiy Analyses C NNNGNN amp Known Lot Unknown n 0571272001 Method BICROMATO 254 Date Time 14 2 2001 11 36 o a Memorize Exi Figure 2 Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 2 of 20 1 2 DISPLAYING AND PROCESSING BY DATE It allows display and data processing after selection of key parameters Analyses Lot Method Type of control Known Unknown and Level The search of controls can be performed for a single data Daily results within a given time range or for a given
146. ght cone and orient the lamp socket in the vertical position as shown in the Figure 5 b Tubular filter for external water container H O BOTTLE Section I BOTTIGLIA H5 0 Tubular Filter The analyzer does not monitor the maintenance of this filter It is included in the annual maintenance kit Replace filter when it malfunctions or totally occluded Figure 6 Figure 6 Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver S Page 6 of 12 c Sampling arms and sampling tubes The analyzer does not monitor the sampling arm maintenance A sampling needle refer to No 6 in Table of Figure 2 is provided for yearly replacement or when necessary in the annual maintenance kit SAMPLING TUBE HEATER SAMPLING NEEDLE Fig 7 To replace the needle Loosen and remove retaining nut with needle from the needle holder Clean or substitute with new needle Gently push in needle into the needle holder until fully seated Carefully remove the needle with retaining ring from the needle holder Clean or replace the needle and firmly secure to the needle holder with retaining ring 1 4 CLEANING OF THE INSTRUMENT It is a Good Laboratory Practice GLP to maintain the instrument in optimal operating conditions The instrument should be fully turned off and the power cord unplugged from the wall outlet prior to performing any cleaning procedure The exterior of the analyzer casing may be cleaned periodically
147. hat after a run test the reports are not immediately available for transmission as these need validation To do this go to Utility menu RS232 and enable the option Accept result to be sent This operation must always be performed after each run test or groups of run test Section Chapter 4 Serial Communication BT2000PL Rev 0 Soft Ver S Page 3 of 16 There is also an additional option for performing validation operation automatically Go to Setup of the analyzer Menu Utility Setup Analyzer go to the Serial fourth from the left and enable the option All results must be sent automatically without validate at the bottom of the page In case of positive response to the request for a report the analyzer transmits Patient code 15 characters LIST tyDO aoo od for Routine or for STATS Sample type S for Serum or U for Urine Number of reports 3 characters For each report Analysis 4 characters GSU cers accu bata characters Check Sum 3 characters lt EOT gt The following is an example of eventual response to the data sent in Sending a patient to BT2000 PLUS 000000000000001RS003GLI 000 000BUN 0010 10COL 00100 0107 lt EOT gt Where 000000000000001 Patient code ispum Identifies STATS list M Identifies the type of patient in this case Serum P
148. he user through samples insertion By clicking over sample s position the tray moves itself to accommodate cup s insertion Once the necessary cups have been inserted it is possible to run the calibration gt Timed Standards Only the codes with programmed times are enabled After selection of tests the calibrations can be run In this case the interval of the automatic calibration starts when test terminates In case the calibrations aren t run then the time count of calibration s interval starts from the moment the selection was made Once the automatic calibration time has expired then a screen message asks the user whether tests should be run next Answer with Yes or In case the answer is yes then the analyzer will proceed as already explained for immediate standards A message asks if there are calibration samples in the plate If the samples are already introduced then respond with Yes the calibration procedure starts automatically lf there are no samples in the plate then answer No In this case a guided procedure will assist the user to introduce samples Confirm with cursor on the sample position the plate prepares for cup insertion After the insertion of necessary cups run the calibration When a negative answer is given to the request for standards run the count of calibrations time interval starts again In case no answer is given to the analyzer message and the analyzer has no tests running
149. he problems have been solved Every time a new reagent bottle is inserted by sector or single reagent the analyzer will read the inserted codes Section I Chapter I Barcode amp Related Functions BT2000 PL Rev 0 Soft Ver 8 Page 4 of 4 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER K 1 WARNINGS AND PRECAUTIONS 1 1 Potential risks during operation and maintenance 1 2 Warnings and precautions 1 3 Waste disposal 1 4 Safe disposal of the unusable instrument Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Page Page Page Page Section I Chapter K Warnings amp Precautions 2000 PL Rev 0 Soft Ver 8 Index 1 WARNINGS AND PRECAUTIONS 1 1 POTENTIAL RISKS DURING OPERATION AND MAINTENANCE USE Although the BT2000 PLUS analyzer system uses high performance components which provide a high degree of safety it is essential that the user takes the usual precautions to safeguard himself and to ensure a safe working environment Biotecnica Instruments S p A only guarantees the workmanship and materials of its products It is the duty of the user to take care of safe operation and no amount of warnings can take place of such care As regards the moving parts in the analyzer these have been appropriately protected to avoid any potential risks to the user and for proper instrument operation and safety However it is highly recommended to exercise e
150. he same direction and at least one result exceeds mean by 25 alternatively two groups of 4 consecutive results exceed the mean by more than 15 in the same direction and at least one result exceeds mean by 25 Daily chart graph The Daily Chart graph provides a global vision of a given lot plotting data on a diagram having the origin represented by the actual mean not by the theoretical value of the same lot and as divisions values such as Mean Standard Deviation 1 Mean Standard Deviation 2 to Mean Standard Deviation 4 In addition the red dashed lines indicate the upper and lower limits of the lot All data within the range will be represented by a green triangle while the out of range data will be plotted using red squares Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 5 of 20 Daily Chart graph Analyses Lot jg Method TRINDER Known Level Daily Control Level Figure 7 clicking the mouse over a given value the graphic its information will be displayed Click Print to print the graph Westgard graph Analyses Date Time 2 2001 1221 Method Level TRINDER 0 Knawn 23 0 Out of limit 1 4 ADDITIONAL FUNCTIONS f Quality Controls Functions Data Preference Export data Selections Export Data Al E za T Import Data AlE I n Re All Data
151. he sampling arm moves to the position for the second reagent corresponding to the appropriate hole for accessing small reagent bottle on the instrument s top It is recommended to calibrate the reagent tray prior to calibrating the sampling arm TRAY Sample tray The sampling arm moves to position 1 of the sample tray Reagents tray It is recommended to insert a large reagent bottle fitted with small bottle into position Z4 prior to the calibration By activating this command the reagents tray moves and puts position Z4 below the hole for the first reagent Center the bottle for the first reagent in this position It is suggested to check also the position for the second reagent Cuvettes tray The washing piston must be centered on the cuvette Check correct centering through the piston up down movement using the command Test 1 2 DIAGNOSTIC FUNCTIONS Diagnostic pages are accessible only from Analyzers main menu Fig 3 The Diagnostic functions are partially reserved for approved service personnel only Therefore the access to some of the functions is password protected It contains the following options Show F C C Show Optical Transmission Show Diagnostic and General Diagnostic Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver 6 Page 4 of 10 Patients Tests Analyzer Utility External Programs Analyzer s utilities Mechanical Calibrations Diagnostic Show S
152. his bottle Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver Page 3 of 17 m Ium Im B uS SS ce big Select All Deselect All nin Select All Deselect All Run e Immediate Standards E Timed Standards e Immediate Controls c Timed Controls a ea m ese exit Or igure Figure 3 Figure 4 The Run Standards and Run Controls functions are available from the Tests main menu or through the specific icons that allow direct access The displayed analysis codes belong to the list generated in the Current tray list RUNNING STANDARDS Standards calibration can be run either on command or automatically at pre determined time intervals refer to Chapter C paragraph 1 5 Calibrations Both choices can coexist The commands are Immediate Standards and Timed Standards Fig 3 gt Immediate Standards Once the button is clicked a list of codes appears select the desired tests and run by pressing Run With Select All or Deselect All commands it is possible to select or deselect the whole list A message will ask the user whether the calibration samples are already present in the tray or not If the samples are already present click Yes and calibration procedure will automatically start Otherwise if calibration samples aren t already placed on the tray click No in this case a procedure will guide t
153. host computer will have to send to analyzer the character SIX 0x02 and expect the character ACK 0x06 as a response At this point the host computer will send data to the analyzer and terminate the communication by sending the character EOT 0x04 It is important to remember that any communication is followed by a response from the analyzer It must be noted that if the parameter to be transmitted is shorter in length than the length requirement of the communication protocol than a space must be added before or after For example the analysis have length 4 therefore to send a code GLI one must add a space before or after to reach the length of 4 characters Patient transmission gt Start communication with sequence STX ACK Send Patient 6008 th oekpaU 15 characters gt Send list type for patient insertion T for Routine or R for STAT P Send type of S for Serum or U for Urine gt Send if the patient is a for Yes N for No gt Transmit position of 00 unknown gt Send number of tests to be from 01 to 99 P Send codes of tests to be 4 characters P Send Check Sum
154. how Optical Trasmission Show Diagnostic General Diagnostic F C C Result 11 2 2002 G8 042 S 0488 443 1 016 451 0 526 447 1 407 450 0 659 451 0 543 450 0 736 453 0 000 450 0 630 450 0 707 450 0 698 453 0 020 455 0 496 456 0 723 452 0 334 457 0 915 456 0 728 455 0 394 457 0 910 457 0 734 449 0 823 454 0 257 452 0 173 460 1 427 458 1153 452 0 280 457 0 930 450 0 753 463 2 165 459 1 314 456 0 656 459 1 194 Print Re Read values O Exit 449 0 333 Figure 4 100 0 100 0 100 0 100 0 100 0 100 0 100 0 Fi 5 m Figure 5 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 E o 100 0 Qen 100 0 100 0 O i 100 0 Figure 5 Section I Chapter H Analyzer Technical Functions Show F C C It shows the optical correction factor calculated for all the reading cuvettes For each cuvette the mABS and the F C C values Figure 4 are reported It also indicates the cuvettes with correction factor exceeding the preset limits Show Optical Transmission After each photometric 1000 zeroing it indicates the percentage transparency of the 1000 cuvettes The cuvettes with poor transparency are highlighted BT2000 PL Rev 0 Soft Ver S8 Page 5 of 10 LK gt gt Show Diagnostic it Clear Diagnostic for S h OWS th e statu S of th e Puce TENER act K
155. in the lower part of the graph the equation for the represented line is shown L Jennings displays L Jennings graph for the selected data Histogram displays the histogram for the selected data Statistical Histogram displays the histogram for the selected data respect to the mean value Mean X X1 Xn selected elements being n the number of elements Xq4 Xo X Ye n Standard Deviation SD is a quantity that measures the spread of data across its mean value If data is mostly located near the mean SD assumes a small value otherwise a large value indicates large data spread ps amp A n 1 Variation coefficient CV is computed as the ratio between mean square error and arithmetic mean CV is a relative quantity and independent from the measurement unit used D5 1 00 X Section I Chapter F Quality Controls BT2000 PL Rev 0 Soft Ver 8 Page 9 of 20 Minimum square line y Where Y XY nYxXy b YY aYx Correlation Coefficient DXI Y Y X X gt X X Y Y CC Variance Sx xx Y n 1 Deviance 2 Median The Median for an ordered ser of data is the central value or the arithmetic mean of the two central values depending on the fact that the number of elements in the set be odd or even In particular the median for N odd elements is the X N 1 2 th element Example given th
156. indows Update Programs Documents gt Settings Control Panel aa SERAS i Network and Dial up Connections Printers BE Taskbar amp Start Menu J Shut Down Windows 2000 Pro Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 13 of 22 Double click on Display icon PAE TER Control Panel Windows Update Select Settings fee e D E els l ZU f DeL Set Screen area to 800 by 600 pixels Section II Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 14 of 22 Click Yes on the Monitor Settings lonitor Settings dd Remove Add Remove Adm Hardware Programs ag Folder Options Fonts Go to Screen Saver emove Add Remove Administr Tools E controipane Click Power at the bottom right Section Chapter 5 Software Installation amp Upgrade BT2000 PL Rev 0 Soft Ver 8 Page 15 of 22 Select the settings Never in Turn off monitor and Turn off disks Power Uptions Properties u Click OK If one desires to select a background picture go to Background page xm j 3 den n Fonts Mouse Id Tp PCS id Th 4 cr E Suns JUNG picture or HTML document as
157. ing and displaying data by date range code patient s name surname test date Moreover the program has a series of built in secondary functions such as 9 9 9 9 Archive backup Printer set up Cancelling the whole archive otart up of the general setup program of the BT2000 PLUS Floppy disk formatting Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver S Page 14 of 20 Selection How to run a Query File Utility Delete Sendto 5232 Help Choose Date lect All Choose Code se Select All 27 02 2003 9 54 45 27 02 2003 9 54 46 27 02 2003 9 54 47 27 02 2003 9 54 48 27 02 2003 9 54 48 28 02 2003 8 52 18 28 02 2003 10 55 57 28 02 2003 10 55 58 sta una ni esta una nol uesta una nota abbas 28 02 2003 10 55 59 Questa una nota abbas F l g u re 2 3 28 02 2003 uesta una nota abbas uesta una nota abbas sta una ni 10 56 00 03 03 2003 10 39 57 03 03 2003 10 40 00 03 03 2003 10 40 00 03 03 2003 10 40 01 03 03 2003 10 40 02 03 03 2003 10 40 02 03 03 2003 10 40 03 03 03 2003 10 40 05 03 03 2003 10 40 06 03 03 2003 10 40 07 03 03 2003 10 40 08 03 03 2003 10 40 09 03 03 2003 10 40 09 04 03 2003 8 09 28 04 03 2003 8 09 29 04 03 2003 8 09 31 04 03 2003 8 09 33 04 03 2003 8 08 33 amp unan iesta amp una nol gt Test Report Print All
158. interference of the sample for example turbid sera from the reaction These are double reagent End Point reactions The reaction and the computation are performed during two distinct phases in the first phase sample blank the reaction between the first reagent and the sample R1 S takes place while in the second phase the second reagent is added to R1 S R1 S R2 The final absorbance used for computing the concentration of the analyte is obtained from the difference in absorbance between the two phases Conc in sample Factor x A2 A1 x k A2 Al R1 S R2 Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 11 of 31 Sample Blank B This kind of reaction is very similar to the previous one The reaction always occurs in two phases in the first phase sample blank the analyzer reads the final absorbance A1 of the reaction between the first reagent and the sample R1 S in the second phase it reads the final absorbance A2 of the reaction between the second reagent and the sample R2 S The two reactions are distinct and separate and the sampling in the two phases takes place in two different reading cuvettes The final absorbance used for computing is obtained from the difference between the two phases Conc in sample Factor x A2 A1 A1 A2 R1 S R2 S End Point 2 Points This method only for single reagent tests is used whenever it is required to eliminate from the reaction the i
159. ion All and Single Position Scan tray Allows positive identification and saves present samples on the tray It is subdivided into the following two functions All The tray performs a rotation scan to make a positive identification and saves all the samples codes in the sera tray Single Position Allows positive identification and saving of only one single code The analyzer requests the desired position and the tray accordingly positions itself for sample s insertion Makes one rotation for reading the present code Scan tray and run Performs reading rotation as before but runs the tests immediately NOTE In patients bar code printing protocols it is possible to add Profile Number which provides total automation in patient acquisition refer to Chapter C paragraph 1 6 Creating Profiles and Chapter paragraph 1 Bar code and related functions During bar code reading the analyzer provides a list of likely errors that occurred In this case the reading can be repeated by re activating the command Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver 8 Page 12 of 17 Extra Patients It displays the acquired patients that haven t been inserted in the run list The user by double clicking on an active position enables Registry Situation with selected code and analyses information It is possible to modify it Options The Options menu allo
160. ion N Caution risk of electric shock black on yellow background N Caution refer to accompanying documents black on yellow background Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page amp of 11 4 BRIEF DESCRIPTION OF THE SYSTEM 4 1 FRONT VIEW OF THE ANALYZER 1 ON OFF BUTTON FOR COMPUTER 2 LCD DISPLAY 3 REFRIGERATED REAGENT COMPARTMENT 4 SAMPLES TRAY o SAMPLING ARM FOR CLINICAL CHEMISTRY 6 FLUIDIC CIRCUIT AND READING STATION 7 INTEGRAL HANDGRIPS 8 DILUENT BOTTLE Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 9 of 11 4 2 REAR PANEL CONTROLS AND CONNECTORS Box Computer Rif Fig 4 EXTERNAL MONITOR MAINS POWER INLET ACCESSORY POWER x 95 245 VAC 47 63Hz 600W CONNECTORS LINE FUSES MAX LOAD OUTPUT 250VOLTS 8AT 100 WATTS TOTAL LOAD 2 OUTPUT 200 WATTS PRINTER TUBO DI STRARIPAMENTO SONDA DI SCARICO co Mic Sound CONNETTORE FISHER S X Line in Sound Line ou SONDA DI SCARICO PS2 PORT MOUSE Sound EX PORT KEYBOARD __ TO UPS RS232 CONNECTOR 1 THE GREEN POWER SWITCH NEAR FLOPPY DRIVE ENABLES THE INGRESSO LY SYSTEM STANDBY MODE ONLY TO TURN OFF POWER TO THE WHOLE SYSTEM PRESS ON OFF MAINS SWITCH ON THE REAR PANEL H O 2 TO PREVENT ELECTRICAL SHOCK UNPLUG POWER CORD FROM THE FOR THE CONTINUED FIRE PROTECTION REPLACE ONLY WITH FUSE AS MARKED 3 DO NOT OPERATE WITHOUT G
161. ion number 2004 Date Approved Yes 0 No LU Repair Exchange Destroy U Quotation Note Approved by Technical Assistance Dept Signature Quality Control Manager Supervising Signature Note No parts or instruments will be accepted for repair or replacement without a Return Authorization number which can be obtained from Biotecnica Instruments S p A Fax this Return Authorization form to 39 06 410 3079 to the attention of Technical Assistance Export Manager who will then evaluate and issue a Return Authorization number WARRANTY EXTRACT Biotecnica Instruments S p A warrants its instruments to be free from defective parts and workmanship for a period of one 1 year from the date of purchase Liability under this warranty is expressly limited to repair or replacement of defective parts at the option of Biotecnica Instruments S p A This warranty does not cover the results of misuse accident or abuse of any parts of its instruments which have been repaired tampered with or altered by anyone other than personnel authorized by Biotecnica Instruments S p A This warranty does not apply to fluid handling devices consumables or reagents Products returned to Biotecnica Instruments S p A for repair or replacement shall be sent with transportation prepaid If found not to be defective under the terms of warranty a charge will be made for repair or replacement and freight costs will be at customer s expense WARRANTY CONDITI
162. irst graph in the memory of Patients will be displayed Using the up down hand keys the user scrolls through different patients while using left right arrow keys the different graphs for a single patient are shown Figure 4 If Single Patient is selected then the analyzer will request its identification code By selecting an identification code among the available in the Skip to code field it is possible to go directly to the single patient IMPORTANT The graphic pages are available only after test runs and prior to data archival Graphs are divided into two parts by 2 dashed orthogonal axes On the left part there is the incubation time graph while on the right there is the reading time graph On the right of the window there are 2 frames containing the information concerning the absorbance determined during the two phases incubation and reading times and AABS that refers to the divisions on the ABS axis Each division in the Time axis is approx 10secs Graph for patient STDOO1 Test 420 E Skip ta Code Figure 4 Section I Chapter G Displa
163. isplay statistics as well as analyses results The input screen Fig 21 shows the following fields Analysis Name Analytical Method Result Date Group and Test Data entry is case sensitive meaning that an analysis name written in capital letters YOU is different from the one written in lower case letters you and is different from the one written with initial upper case letter You Every time a new analyses is inserted the window does not close automatically instead the same window is displayed again with the fields Analysis Name and Analytical Method showing the preset values of the analysis just inserted Other menu functions The main menu contains two additional sub menus with the following options FILE Backup creates a backup of the archive in a floppy disk Restore Backup restores the archive backup from a floppy disk Exit closes the population archive and goes back to the operating program UTILITY New Record allows external analyses to be stored into the population archive see paragraph 2 4 and Fig 21 Delete Records selected records in the archive can be randomly selected by holding pressed the Ctrl key while clicking with the mouse Once selected the records can be deleted by clicking on this button Delete Analysis Data this command will delete the archive all records corresponding to the selection made i e if selection is Backup Res
164. it Tubes and Peristaltic pump Va ri O u S p a rts of th e Photometric Lamp 71500 Hours 3 1 2005 Photometric Lamp 71500 Hours syste Im th at S h O U d be replaced regularly This page shows the consumable parts life cycles remaining cycles and the replacement date Figure 6 When at the analyzer start up the message There are the Figure 6 following obligations in diagnostic appears it means that the indicated item has to be replaced or an action has to be undertaken In the Show Diagnostic page there will be one or more flashing lines corresponding to the parts needing replacement refer to Chapter N Once the required maintenance has been performed reset the internal counters of the analyzer by clicking on the single voice described in the table on the right side General Diagnostic This function is reserved for the Technical Assistance personnel for diagnosing problems which cause analyzer malfunction There is free access to most of this program However the use of this program without the proper supervision of approved technical personnel is user s responsibility Therefore it is highly recommended that the operator is assisted by the specialized technical personnel when using this program This command verifies the operation of the following devices and the operating phases 1 Photometer stability and operation 2 Hydraulic functions sampling washing and emptying of cuvettes 3 Barcode oper
165. ith analysis GLI BUN and COL onto the STATS list then one must send the following sequence of characters excluding initial sequence STX 2ACK 000000000000001RSN0003GLI BUN COL 134 lt EOT gt Where 000000000000001 Patient code URS Identifies STATS list Snob Identifies the type of patient in this case Serum No Identifies that the patient is not a clone OO LM Unknown position the analyzer will insert the patient a convenient position eee identifies the number of test to be executed GLI BUN COL Test codes observe the space after each code to reach the 4 characters limit jT Identifies the Check Sum SEQ T gt 9 2 This character ends communication Results reception There are three commands for receiving reports from the analyzer Reception of next available report Reception of the last report sent in case of reception problems Reception of the first available report in case one desires to receive again all the reports The commands R L and A require standard communication or the procedure ST X lt gt ACK and the character EOT to end communication As a response to one of these three commands the analyzer sends the requested report if available or the character NAK 0x15 if there is no report to be sent It must be borne in mind t
166. itial Aate Latex irc P i Sample Blank type B 9 ime Only Read End Point 2 Points Sample Blank A b End Point 2 Paints Sample Blank B b From End Point Starter Absolute End Point Figure 13 linear This function is used for linear reactions it requires analytical test calibration to process computing factor with factor It is used for linear reactions whenever the computing factor is known with curve Non linear tests distinguished by Polynomial It is used for non linear tests Here an almost perfect cubic approximation curve is generated which lacks infinite approximations on too distant points Cubic spline It is used for non linear reactions A cubic interpolation is created for solving the problems of polynomial curve in some particular cases the approximation is zero on the points not flex point free Log logit 4 and Log logit 5 It is a logarithmic approximation on four or five points used for non linear tests Multi point Linear interpolating function for several standard concentrations max 6 It mathematically extrapolates data that are out of calibration s limit Minimum squares Used in non linear reactions A minimum squares approximation is created for solving the problems of polynomial amp spline curves in some particular cases and is flex point free Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 18 of 31 Line for two point
167. l 37 00 101 5 VED FUA C 93 44 mud 41 00 77 50 Fig 32 In this kind of printout all patient data are shown followed by the analyses list with analytical method result with flags and normal range The last kind of printout Compress Report will produce a different kind of report where only analyses are listed with no reference to the pertinent patient Fig 33 Glucosio Trinder 51 98 Ul dl 47 00 126 5 Bilirubina XXX 16 16 Ul dl 43 00 109 5 Lipasi Jundrassik 55 45 13 00 78 50 FAC Jundrassik 31 46 mg L 20 00 81 00 RAT Color 43 37 mg dl 42 00 118 0 Glicemia Jundrassik 91 30 mg L 36 00 102 0 BID Color 87 86 Ulfdl 34 00 90 00 RAT 19 74 Ul 40 00 91 00 Bilirubina XXX 42 18 117 52 00 121 0 Color 43 46 Ulidl 51 00 107 5 VED Trinder 57 65 mg dl 33 00 62 50 PRY Trinder 54 49 Ul dl 31 00 62 50 VED Jundrassik 63 48 mg dl 49 00 115 5 Colesterolo XXX 11 57 mg dl 27 00 66 50 Glicemia 30000 51 96 mg dl 28 00 56 00 BID XXX 55 80 mg dl 45 00 109 5 Riliriihina Trinrer Fi 23 49 00 106 5 ig Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 19 of 20 Additional menu functions In the main page Patient Archives Fig 23 some menus are available as shown below File Utility Delete 5232 Help Eile Utility Exit Utility Delete Sendta 5252 Help 5Setllp Backup View External Archive View Internal Archive For
168. l Time i e urgent positions positions Control Displays Control positions Standard Displays Calibrator positions New Entry Displays window for entering data of Routine STAT and Control samples Extra Patients Displays the list of patients with no assigned position Patients selected in the work list may be moved here Options menu Send to extra patients command and then back Exit To leave program press Exit Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 8 of 16 Example of entering samples New Entry Routine Type Code Group Assigned Group Man Serum Routine C Woman Urine C CTRL Routine Sumame C Child Name Draw Date External dilution factor 06 03 02 fi 00 Note Position EN ca Test B Profile E Delete 3 Save ig Run Exit Available profiles Analyses oH ae Select aro oH ela Deselected E Max selectable tests 50 Remaining 50 Figure 9 After the selection of Routine followed by confirmation through command New Entry the patients acquisition frame is displayed Figure 9 The programmed patient can be executed immediately or saved for later use The programming fields and the functions are outlined below Code It is the identification number assigned by the user to the patient It is possible to assign an already given code thus creating a cl
169. le profiles Analyses selectable tests 50 Remaining 50 Figure 7 Delete Cancels the programmed patient Confirmation is requested Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page 8 of 17 Save Saves patients data and the associated analyses With this command test execution is delayed NOTE In the routine programming it is possible to acquire a greater number of patients than the available number of positions in samples tray All the patients acquired with no associated position are saved and displayed in the extra patients list and can be transferred to the main list on user s demand refer to paragraph 1 5 Work Lists Run This command immediately starts the execution of the programmed patient The sample plate adjusts itself to match the position assigned to the patient and a blinking red LED indicates the position for inserting cup or primary tube If patient code is missing or no analyses have been selected then this command cannot be activated New Entry STAT After the selection of STAT followed by confirmation through New Entry the STAT acquisition frame is displayed Figure 8 Bear in mind that the tray positions reserved for emergencies are the ones assigned in the Analyzer Setup Chapter H paragraph 2 An appropriate screen message alerts the user when a wrong position number is entered Patients acquired as STAT can be save
170. lems of contaminations and carry over In such situations it is highly recommended to perform thorough washing of cuvettes using appropriate solution during extra wash followed by a washing cycle Consult factory for additional information regarding the washing procedure already described previously WARNING a DISPOSABLE GLOVES MUST BE WORN OR ADEQUATE SAFETY MEASURES MUST BE TAKEN FOR PERSONAL PROTECTION WHEN HANDLING THE SYSTEM WHERE HANDS MAY CONTACT POTENTIALLY CONTAMINATED WASTE MATERIALS CHEMICAL PRODUCTS SERUM REAGENTS AND ETC b THE SAFE DISPOSAL OF THE WASTE MATERIALS IS THE RESPONSIBILITY OF THE USER INSURE THAT THE DISPOSAL OF WASTE CONTAINER FLUIDS IS DONE ACCORDING TO ALL APPLICABLE LAWS AND REGULATIONS m I gl I INI PEN o Im IE iI B PF UO AV WASHERIDILUITOR SYSTEM BT 2000 PLUS READING STATION Figure 2 Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Rev 0 Soft Ver 6 Page 4 of 12 SIX MONTH MAINTENANCE KIT P N 662 2000 QTY MN Peristaltic Pump Cartridge ANNUAL MAINTENANCE KIT P N 662 2001 Table of Figure 2 1 3 ADDITIONAL MAINTENANCES a Photometric lamp replacement The analyzer controls the Halogen lamp condition and it should be replaced annually or when there is a faulty operation The analyzer verifies lamp efficiency and stability and alerts the user through appropriate messages in case of fault s
171. line and be complete In other words a single command cannot be divided into more lines Stringn Name 10 gt Valid line Stringn Name 10 char A gt Invalid line Stringn Name gt Invalid Command 10 An editor for writing modifications saving and compiling of one or more scripts is accessible inside the program setup function In any case it is possible to write a script with any text editor DOS or Windows like Notepad of Windows or the EDITOR of the DOS It is not possible to import documents written with UNIX as the characters used for going to the next line are different from the ones used by the DOS or Windows CAUTION If one wants to use the script stored in a removable disk for example floppy disk then it will be necessary to copy it on the hard disk Section Chapter 4 Serial Communication BT2000 PL 0 Soft Ver S Page 6 of 16 TYPE OF DATA Character String Comment Variables Identifies a single character can pass as printable character enclosed between single apostrophes as decimal ASCII value followed by symbol or else hexadecimal ASCII value followed by Ox lf for example we want to identify the character A decimal value 65 or hexadecimal value 41 then we can write A 65 or 0x41 Identifies a sequence of printable characters enclosed in single apostrophes for example this is a string Identifies a portion of test preceded by a character which
172. lling up cycle with distilled water of the hydraulic circuit and sampling system Zeroing on water Performs photometer zeroing with distilled water This procedure can be performed either on request or automatically When the analyzer is turned on the zeroing is required It is highly recommended to allow the analyzer to reach steady state approximately 20 minutes before running the zeroing Check volumes The analyzer checks the volumes of reagents present in the reagent tray These volumes are updated in the corresponding window Reagents status for the reagents insertion procedure F10 key Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver 6 Page 2 of 10 Volumes calibration A screen message invites to insert a large bottle fitted with a small bottle 10 ml both empty into the position number 1 of the reagents tray It then asks to insert an empty sample cup into position 1 of the sample plate These are automatically and gradually filled up with distilled water in order to create references for determining the volumes of the bottles and the cup F C C calculation This procedure is for calculating the optical correction factor for the reading cuvettes A screen message invites to insert a bottle with appropriate solution into the position 40 of the reagents tray Generally a solution of Potassium Bichromate with absorbance between 0 500 Abs and 1 200 Abs read at 340 700nm is used The analy
173. lockwise or counterclockwise The Test command verifies the correct centering of the sampling needle by moving it up and down NOTE It is highly recommended to calibrate the trays Sample Reagent Cuvette first and then the positions of sampling arm In addition the sampling needle must be centered on the required positions Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver 6 Page 3 of 10 Calibrations Clinical Chemistry Arm ex Washing position Direct Access Icon gi Arm an 1st ring p2 Arm on 2nd ring p3 Amm an 3rd ring a tray 4 Arm on 4th ring 1st reagent Cuvette tray ra 2nd reagent 0 Arm on diluent Js Cuvettes position No option selected Figure 2 CLINICAL CHEMISTRY ARM Washing position Arm remains on the washing position upon which it must be centered Cuvettes position The sampling arm moves over cuvettes tray The sampling needle must be centered on the cuvette Arm 1 ring The sampling arm moves to position 1 of the 1 ring outer circle Insert an empty cup into the tray to better observe the position Arm on 2 ring The sampling arm moves to position 27 of the 2 ring Arm on 3 ring The sampling arm moves to position 1 of the 3 ring Arm 4 ring The sampling arm moves to position 14 of the 4 ring 1 reagent the sampling arm moves to the appropriate hole on the instrument s top for accessing 1st reagent 2 reagent T
174. ls of the above Scripts Stringn PatientCode 15 Patient Code of fixed length equal to 15 characters Char PatientListl ype Type of list Routine STAT as single character Char PatientType Serum type Serum Urine as single character Char PatientClone Identifies if the patient is or is not a clone single character Stringn PatientCupPosition 2 Position of serum cup string of fixed length equal to 2 characters Stringn PatientNumberTest 2 Number of tests to be executed string of fixed length equal to 2 characters Set BeginAnalysesData Beginning of analysis codes Stringn ZAnalysesCode 4 An analysis code of fixed length equal to 4 characters It must be entered for each type of test as per qty indicated in the ZPatientNumberTest Set EndAnalysesData End of analysis codes Stringn CheckSum 3 Check Sum transferred as a string of fixed length equal to 3 characters The following examples are the transformation in script of the standard routine for the transmission of a report by the analyzer to the host computer Stringn PatientCode 15 Char PatientType stringn PatientNumberTest 3 Set BeginAnalysesData Stringn AnalysesCode 04 Stringn AnalysesConcentration2 7 Set EndAnalysesData Stringn CheckSum 3 The details of the above scripts are as follows Stringn PatientCode 15 Patient Code of fixed length equal to 15 characters Char PatientType Serum type Serum Urine as single character
175. lution 1 ratio of dilution repetitions Maximum pre dilution limit is 1 499 In case both ratios are set the user can work within this limit or in case a higher limit is necessary then an external dilution must be performed refer to chapter E paragraph 1 4 Samples Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 20 of 31 Pre Dilution 1 Set sample s pre dilution ratio only if required by the methodic otherwise enter 1 for not to predilute Dilution 1 Set the sample s dilution ratio to be used for automatic repetitions of tests which during the determination have either Max ABS Delta or Final ABS or Test Limit values out of the programmed limits see ensuing Control Parameters The user can then set an adequate dilution ratio in order to bring the reaction into linearity limits Urine Parameters Fig 18 Name enter the complete name Urine pl sample volume expressed in ul 100 ul max Dilution The programming of fields text boxes for Pre Dilution 1 and Dilution 1 the procedure is identical to the above mentioned Serum Parameters Times this command allows setting of incubation and reading times Move the mouse cursor over Times command and click to confirm a form appears on a side of the screen with programmable fields Fig 19 The user can then enter the following information arameters for Clinical Chemistry 00 Primary parameters Check Parameters
176. ly switched off without following the proper shutdown procedure Chapter E paragraph 1 6 Execute a washing procedure Chapter H paragraph 1 1 to prevent continuous appearance of this message This message does not stop test execution but it is not possible to guarantee correct results if an effective Extra Wash is not performed The error message NO SAMPLE DILUENT is displayed when the analyzer detects the absence of sample diluent solution and instantly the testing of samples to be prediluted is interrupted To solve the problem add fresh diluent solution and re run the sample Chapter E paragraph 1 5 BT2000 PL Rev 0 Soft Ver 6 Page 9 of 12 2 2 2 SCREEN MESSAGES REQUIRING TECHNICAL ASSISTANCE SCREEN MESSAGE CAUSES amp REMEDIES This message stops the execution of programmed tests The message ERROR RESETTING SAMPLE TRAY is generated by an incorrect home position of ERROR RESETTING the sample tray This error can be caused either by an SAMPLE TRAY absence of sample tray or defective position sensor In case of a wrong positioning or absence of sample tray correctly position the sample tray in its chamber and then press F5 Reset key to restore correct analyzer operation In case of defective position sensor contact qualified technical assistance to solve the problem This message stops the execution of programmed tests The message ERROR RESETTING REAGENT TRAY is activated by an incorrect z
177. m Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords Cu stomizes the printouts __ generated by the analyzer in the wssese zif Archive and Quality Control Utilities Figure 9 Two editable fields are displayed for programming of HEADER amp FOOTER Characters can be formatted B for bold U for underline I italic as needed Font type size and text color are also available To print Figure 9 a test page click Test button Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver Page 7 of 10 Bar Code Enables bar code Language System Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords scanning option Figure 10 2 TT Confirm Present to enable it xa ee 1200356789 or Not Present to disable it With bar code enabled further options are On Samples and Length 13 Digits 77 C Mis ia Use a digit for Serum Urine On Reagents or just one of Use one or two digits for profile number the two r Setup Bar Code on Reagents Setup Bar Code on Samples 0 Dimension Sample Code ID 0 V ariable Setup Bar code on Samples j This function customizes the M 9 contents of the patient code Figure 10 reported on the bar coded label
178. m memory of the barcode scanner module Ean13 code39 Codabar Interleaved 2 of 5 6 Interleaved 2 of 5 8 Interleaved 2 of 5 10 The scanner automatically detects the presence of one of the preceding codes on the barcode label Additional codes can be programmed upon request These are available in groups of 5 see below and can be loaded into the scanning module using a floppy disk Codes available upon request CODE39 CODE39 FULL ASCHII CODABAR CODE128 EAN128 CODE93 PLESSEY PHARMACODE EAN13 UPCA UPCE EAN13 AddON2 EAN8 AddOn2 UPCA AddOn2 UPCE AddOn2 EAN13 AddOn5 EAN8 AddOn5 UPCA AddOn5 UPCE AddOn5 Suggested dimensions for the labels Although the analyzer is equipped with a high quality barcode scanner the labels of improper dimensions or defective labels may not be read For correct readings the barcode label should be properly centered on the tube and should have dimensions between xxx cm and xxx cm The barcode on the label should be completely visible after the tube has been inserted into the sample plate It must not be partially covered on the top and the bottom If the tube is partially covered by barcode then the tube must be positioned in such a way that the barcode is facing outwards of the sample plate Section I Chapter I Barcode amp Related Functions BT2000 PL Rev 0 Soft Ver 8 Page 3 of 4 2 2 BARCODE ON REAGENTS The analyzer has the possibility to work either as closed system or open sys
179. mables for BT2000 PLUS CHAPTER 4 4 SOFTWARE 4 1 Serial Communication between BT2000 PLUS and Host Computer 4 2 Variable communication protocol 4 2 1 Serial communication test programs CHAPTER 5 5 INSTALLATION OF THE OPERATING SYSTEM 5 1 Preliminary phase 5 2 Setup of the Operating System 5 3 Completing the Installation 5 4 Settings of the Operating System 5 5 Installation of the BT2000 PLUS Operating Program 5 6 Upgrading the BT2000 PLUS software CHAPTER 6 6 TECHNICAL ASSISTANCE CHAPTER 7 7 BIBLIOGRAPHY OF ALLIED SUBJECTS CHAPTER 8 8 LIST OF APPLICATIVE METHODOLOGIES Index BT2000 PLUS Rev 0 Soft Ver 8 Page 4 of 4 Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page ONN OPERATOR MANUAL BT 1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER A 1 INTRODUCTION 2 BASIC OPERATING PRINCIPLES OF THE ANALYZER 3 SYMBOLS explanation of the used or applied symbols 4 BRIEF DESCRIPTION OF THE SYSTEM 4 1 Front view of the analyzer 4 2 Rear Panel Controls and Connectors 4 3 Modules IMPORTANT NOTICE Page Page Page Page Page Page Page The introduction of access passwords has been rendered mandatory since 2004 for safeguarding sensitive data refer to CHAPTER E paragraph 1 7 NOTE This manual is valid for both BT1000 and BT 2000PLUS The following components are not installed on the BT1000 a Reag
180. mat Floppy Shift F 7 O Delete 5232 Help Delete Records selected Delete All Search Delete All Archive Send to R5232 Help Send Record s Selected Send All Search FILE in this menu the only command available is Exit which is used to close the Patients Archive program UTILITY the following commands are available SetUp opens the printer setup Backup creates a backup copy of the selected search without deleting files from the HD To create the backup it is necessary to first perform a search then select a location for the backup files View External Archive click on this button select the location where the backup files are and then press the search button to view data View Internal Archive press this button to go back to the internal archive after having viewed an external backup file Format Floppy it is used to format a floppy disk DELETE the following commands are available Delete Records Selected Allows deletion of only the randomly selected records Delete All Search it deletes the whole performed search Delete All Archive it deletes the whole archive SEND TO RS232 Send Records Selected sends randomly selected records to the host computer Send All Search sends the whole performed search to the host computer HELP displays the help on line window Section I Chapter F Quality Controls 2000 PL Rev 0 So
181. matical functions Page 1 2 3 Initial computation Page 1 2 4 Optimization techniques for Clinical Chemistry Page 1 2 5 Methods Description Page 1 3 Analyses Programming Page 1 3 1 Creating a New Code Page 1 3 2 Relation Tests Page 1 3 3 Primary Analytical Parameters Page 1 3 4 Check Parameters Page 1 3 5 Secondary Analytical Parameters Page 1 3 6 Automatic re runs Page 1 4 Controls Page 1 5 Calibrations Page 1 6 Creating Profiles Page 1 7 Creating the Current Analyses Tray Page Q gt aa ao gt Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 INDEX 1 FUNCTIONS 1 1 DESCRIPTION OF THE PROGRAM MENU As already described in the Chapter A the BT2000 PLUS is a clinical chemistry automated analyzer for programming and performing tests in Routine programming per patient Batch samples per test and STATs on serum plasma and urine The single samples are always accessed in random mode Besides the clinical chemistry it is possible to perform turbidimetry tests immunochemistry for specific Proteins pharmaceuticals and drug abuse Once the program is loaded the main page appears where it is possible to enter all the menus These are available in two variants the horizontal and the vertical menu bars Moreover there is the icon bar that can be used
182. ml approximately 250 ml approximately 170 ml approximately approx 170 ml 13 ml Cuvettes Washing Solution DATA MANAGEMENT Computer gt Pentium IV gt 2400 MHz or more IBM compatible DVD CD Rom Player gt 16X Hard disk gt 20 Gb Floppy Disk Drive 1 44 Mb Monitor LCD Display Module TFT 12 with integrated touchscreen Interface 2 Serial Ports RS232C 2 USB PORTS Printer Ink jet Color IBM compatible or other Mouse amp keyboard Cordless External Modem Optional Error Messages Visible Vocal optional 1 As regards the technical specifications for the system instrumentation reagent used in the applications of kit these are the responsibility of kit s manufacturer and will be stated in the applications refer to the instructions accompanying the kits 2 The analyzer BT2000 PLUS does not require after sales regular calibration and mechanical adjustment procedures There are mechanical and electronic adjustments performed by the manufacturer Biotecnica Instruments S p A during assembly and quality controls These adjustments may be performed again in case required by a particular technical service and in any case are at the discretion of the authorized technical personnel only However It is highly recommended to check the system periodically to prevent any faults or malfunction of the analyzer Section I Chapter M Technical Specs 2000 PL Rev 0 Soft Ver Page 4 of 4 OPERATOR MANUAL BT1000 amp B
183. mperature Sets working temperature for reading cuvettes activates the refrigerator for the reagents Click to select the desired temperature among the available Figure 12 e Room Temperature e 32 C e 37 C Enable Reagent Refrigerator If not selected it excludes the reagent refrigeration Samples Tray Customizes samples tray Figure 13 Here it is possible to change the number of positions dedicated to the samples of Routine STAT Standards and Controls Routine and STAT positions are included in the two outermost rings with progressive numeration from 1 to 52 Standard and Controls positions are in the innermost rings with progressive numeration from 1 to 26 It is not possible to exclude one typology to advantage of the other one The minimum number of assignable positions is 1 for the Routine STAT and Standards and 3 for the controls Click up down arrows to increase decrease the number of dedicated positions or write the desired number into the textbox The analyzer will automatically upgrade the positions for the second item of the pair every time the first one is changed Level 1 C Level 2 C Level 3 Select level to modify Language System Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords Modify password Old password P New password Re enter password Section I Setup Utili
184. n Controls Only the codes with programmed times are enabled After selection of tests the controls can be run In this case the interval of the automatic execution starts when test terminates In case the controls aren t run then the count of execution time interval starts from the moment the selection was made Once the automatic execution time has expired then a screen message asks the user whether tests should be run hereafter Answer with Yes or In case the answer is yes then the analyzer will proceed as already explained A message asks if there are samples in the plate If the samples are already introduced then respond with Yes the execution procedure starts automatically If there are no samples in the plate then answer No In this case a guided procedure will assist the user to introduce samples Confirm with cursor on the sample position the plate prepares itself for cup insertion After the insertion of necessary cups start the run When a negative answer is given to the request for execution of controls the count of automatic execution time interval starts again In case no answer is given and the analyzer has no tests running then after 3 minutes it is considered automatically as a negative answer and a screen displays message of no test execution With the analyses in process the analyzer proceeds with the execution of the controls But if there are no reagents or samples this procedure is interrupted and the c
185. n run during patients execution It is a percentage check made between current and previous calibration It compares the newly determined data with already stored data If the programmed limit is surpassed then a message informs the user and the previous positive calibration will remain intact in memory Last Standardization This field displays date and time for the last stored positive calibration common to all the analyses By double clicking over the date textbox it is possible to display the previous calibration parameters Simply selecting the Restore button can restore this calibration Print This command prints calibration parameters Save This command saves data and then closes the window Cancel This command exits without saving Non Linear analyses These tests require from 3 to 6 standards If the type of process is Multi Point analyses then the number to be inserted in the Number of Samples field varies from minimum 2 standards to maximum 6 standards The corresponding number of programmable textboxes for positions and standards concentrations are automatically displayed Log logit 4 and 5 will use respectively 4 or 5 standards The values are automatically updated in the ABS boxes during the calibration if known then the user can insert these manually The programming is similar to the one for linear analyses but in this case the standards automatic dilution is also available Section I Chapter C Functi
186. nd transferred as lt Group name gt for the SET Too little data 10 Empty string Unknown variable 12 3 1 r command Damaged exit file Hard disk error Contact sales service SET command not closed The SET END not inserted in the script Too many SET commands More than one SET BEGIN command inserted SET command not found The SET BEGIN command not found in the script command as Group name gt for the SET command the SET command the SET BEGIN command type Char 15 16 17 18 19 20 1 2 Section Chapter 4 Serial Communication 2000 Rev 0 Soft Ver S Page9 of 16 TABEL 1 TRANSMISSION The following variables are used for the transmission of a report from analyzer to the host computer PATIENTCODE Patient Code String PATIENTNAME Patient Name String PATIENTSURNAME Patient Surname String PATIENTGROUP Group String Character PATIENTLISTTYPE List 2 String Character PATIENTTYPE Method Type String Character PATIENTNOTE Descriptive Note otring PATIENTNUMBERTEST Number of Results otring Character CHECKSUM Check Sum otring Character ANALYSESCODE Analysis Code otring ANALYSENAME Analysis name otring ANALYSESTYPE Analysis Type String Character ANALYSESCONCENTRATION 1 1st Concentration otring ANALYSESCONCENTRATION2 2nd Concentration otring ANALYSESFLAGS1 Flag 1st Result String ANALYSESFLAGS2 Flag 2nd Result String ANALYSESMINVALUE Minimum Value otring ANALYSESMAXV
187. nd double reagent methodologies The Reading only method uses only a single reagent and the Sample Blank A amp B methods require exclusively double reagent methodologies 1 3 ANALYSIS PROGRAMMING The analyzer can store virtually endless analysis codes with parameters There are two different codes lists a global All Tests list where all programmed codes are stored and an on line reagents tray Current Tray list where only the codes for the analyses that have their reagent in the tray are stored Patients standards and controls can be programmed and performed only for the on line list Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 14 of 31 21 151 rams a 8 8 00 ntrol obal tan Fig 6 The analysis programming page can be accessed from the main menu Tests or from the specific icon that gives direct access see Chapter A paragraph 3 icon n 1 in the Function Icons Bar Fig 6 To set out new analyses it is necessary first to create the code this function is enabled only in the All Tests and then to assign the parameters the standards and the controls these are enabled also in the Current Tray To perform any test it is necessary to move its code from the All Tests to the Current Tray by using the command Modify Current Tray Function Icons
188. nic range box appears similar to the Normal range it allows programming the limits beyond which the analyzer performs test re run Values in the Panic range can be different from those in the Normal range tests e Profile it is available when automatic hyperactive pathological re run option is enabled and it allows automatic execution of analyses to be associated to programmed test To set move the mouse cursor over Profile command and click to confirm The available analyses list will then appear select the tests to be associated and store with Save command Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 24 of 31 GENERAL CONSIDERATIONS ON TEST LIMIT REACTION LIMIT AND MAX DELTA ABS These three parameters are used to monitor a likely hyperactive situation in a sample whether it is serum or urine With automatic hyperactive samples re run option enabled the analyzer produces two results the first value indicates the specific parameter that has been passed for example if Reaction Limit has been passed the A flag is displayed while the second one indicates what has been detected after repetition In case the automatic sample s re run has not been sufficient to restore the reaction within programmed limits the user can insert a manually pre diluted sample For this purpose a field called Dilution Factor has been added to the patient entry page During check in or sample s re run phase it is p
189. ning on procedure for the first time 1 Turn on the UPS device as described in the appropriate supplied manual 2 Power on the printer refer to the specific manual enclosed Section I Chapter B Unpacking amp Installation 2000 PLUS Rev 0 Soft Ver Page 7 of 9 3 To switch on the analyzer use the mains power switch on the rear panel of the instrument This button activates only the refrigerating system for the reagents To properly turn on the analyzer system momentarily press the push button under the Floppy Disk display Figure 9 CAUTION Do not press this push button during analyzer operation because when pressed it stops the instrument leaving only the refrigerating system on refer to Paragraph 1 6 Chapter E Turning off the instrument 4 Once turning on procedure has completed lasting about 1 minute wait for the system to warm up During warm up phase the temperature indicator flashes on the bottom right of the display until the appropriate temperature is reached The instrument reaches the steady state after approximately 20 minutes 5 After turning on the system there is an access password requirement Refer to Chapter E paragraph 1 7 ACCESS PASSWORD regarding the utilization of the password 6 Prime the hydraulic circuit using the commands outlined in Chapter H paragraph 1 1 Service Functions Dilutor prime Wash and fill up DVD ROM 2 n FLOPPY F DISK POWER BUTTON COMPUTE
190. ns The Service functions are divided into Analyzer Utilities and Mechanical Calibrations These functions are accessed from Analyzer s main menu or through the appropriate direct access icons The Diagnostic function is accessible only through the menu Analyzer has the following commands Show F C C Show Optical password protected Show Diagnostic and the General Diagnostic 1 1 1 ANALYZER UTILITIES Analyzer s utilities I 5 ff Wash cuvettes E m water Wash and fill up Check volumes 1 5 us Extra wash Volumes calibration Direct Access Icon Dilutor prime L F C E calculation Empty Fluidics E B Lamp Setup i Temperature test Figure 1 To activate any of the following commands click on the corresponding button Figure 1 Wash cuvettes Washes with distilled water and dries all the reading cuvettes Wash and fill up Washes and fills cuvettes with distilled water This procedure can be performed either on request or automatically After 20 minutes of total inactivity the analyzer enters the sleep mode and washes the cuvettes Extra wash It is used for complete washing with appropriate washing solution of the hydraulic circuit and cuvettes When this function is activated a message prompts the user to insert into the reagent tray in the position matching with the arrow 39 a large bottle containing washing solution Dilutor prime Performs a fi
191. nterference due to the sample The absorbance of the first reading in incubation phase is subtracted from the final absorbance Conc in Sample Factor x A3 A1 DELAY Time NCUBATION TIME READING TIME Only Read This method is used to read in End Point solely the sample with a reagent blank It can be used to read an already prepared manually solution The factor for the computation can be either derived from calibration or set by the user Conc in Sample Factor x final A Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 12 of 31 For all the methods except for Only Read it is possible to work with one or two reagents These reagents can be ready to use or concentrated in this case the analyzer provides automatic dilution The reagents can be placed in bottles of different volumes 50 ml 80 ml 20 ml and 10 ml and in case of double reagent the different size bottles are coupled together e g 80 10 10 20 50 50 10710 etc The End Point Fixed Time Kinetic and IR methods allow both with single and double reagent the use of a special feature called Serum Starter Normally during test runs the same preparation arm samples single or double reagents plus sample By using the Serum Starter function the reagents are placed into the cuvette by the main preparation arm and the sample is placed separately by the secondary arm In this way the reagents can incubate in the cuvette for the
192. o send or receive numerical information for example number of tests not as single byte but as a preset numerical string or vice versa For example the user can decide to receive something like Section Chapter 4 Serial Communication BT2000PL Rev 0 Soft Ver S Page 5 of 16 Initiate analysis data lt Analysis data true and typical gt End analysis data Where the phrases Initiate analysis data and End analysis data do not refer to any preset data by the analyzer but serve only for monitoring communication process can be useful for inserting specific markers on those programs which obtain information from text files It is obvious that the protocol of initiation and end of communication the commands for the request of report and the analyzer responses in case of error or success remain identical to the usual preset serial communication NOTE a If a check sum is omitted in a communication then the analyzer will not control it b The following numbers have been used to represent the error codes relevant to sending a patient to the analyzer as regards the parameters not part of the standard serial communication 1 Number of invalid analysis 2 Invalid Data not through variables Invalid Data dunes variables 4 An analysis variable is outside the SET BEGIN END relative to the analysis Notes regarding Scripts A script is a text document Each one of the single commands must each reside in a different
193. o start the analyzer press the mains switch on the rear panel of the instrument This operation turns on only the refrigeration chamber for the reagents Start the computer by briefly pressing the push button under the screen Figure 1 CAUTION Do not press this push button during analyzer operation Bear in mind that if this button is pressed again it shuts down the analyzer but not completely leaving only the refrigeration chamber turned on refer to Chapter E paragraph 1 6 Turning off procedure 4 Once turning on is completed lasting approximately 1 minute wait for the instrument to warm up During the warm up period the LED bar indicator flashes until the proper temperature is reached The instrument reaches the steady state in approximately 20 minutes after power on DVD ROM FLOPPY DISK zum 9 POWER BUTTON COMPUTER Fig 1 5 Verify the presence of the washing liquid at least for the daily needs It consists of bi distilled plus surfactant 1 1 of water ratio 1 1000 6 Verify that waste liquid containers are empty or at least have the capacity to contain the quantity of liquid produced during the working day NOTE It is important to observe steps 2 5 and 6 to ensure a continuous operation of the analyzer without interruptions Analyzer s utilities Wash cuvettes Direct Access Icon Wash and fill up Extra wash P Volumes calibration FEC calculation
194. of related profiles or on demand Measurement direct reading of 25 cuvettes in optical glass Sample Tray Capacity 52 positions for Samples amp STAT 26 for Standard and Controls Bar code scanner 2 distinct readers for positive identification of samples and reagents TIME REQUIRED TO REACH STEADY STATE Ambient conditions 21 C R T 33 RH Time required for the analyzer to reach steady state 20 min Ambient conditions 21 C R T 33 RH Time required for refrigerated bottles to reach steady state approximately 2 hours CLINICAL CHEMISTRY Sampling Cycle 17 seconds Analytical throughput 210 tests hour single reagent Test processing time max 360 seconds CUVETTE OPERATING TEMPERATURE Programmable Temperatures Room Temperature 32 C and 37 C Precision 0 2 C Accuracy 0 2 C Temperature Monitoring Device based on Peltier Effect REAGENT CHAMBER TEMPERATURE Nominal Temperature 11 C Approx Temperature Monitoring Device based on Peltier Effect OPERATING AMBIENT TEMPERATURE 18 C to 32 C 10 to 90 RH Non condensating DIMENSIONS AND WEIGHT NOTE weight and dimensions shown are approximate Instrument Kg 85 Packaged Instrument Kg 105 Accessories Kg 25 Packaged Accessories Instrument s Dimensions 58 cm 23 Packaged Instrument s Dimensions L 120 cm 47 29 Packaged Accessories Dimensions L 70 28 D 70 28 ANALYZER POWER REQUIREMENTS Universal Input 90 240 V 50 60 Hz
195. ollowing eee 9 If selected the patients will be J S options Figure 8 is Icons It enables or disables Piin the displaying of the icons on top Print out real time results with color of th e screen Print out real time results with final report If selected the patients will be Navigation Bar It enables Use Ey pean Menu extra patients list in disables the displaying of the navigation bar on the left side of the screen Voice it enables or disables vocal function vocal messages Language System Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords Invisible Invisible C n any case Figure 8 Use European Menu If disabled it changes the menu bar as well as the operating functions from European mode to the ones exclusively dedicated to USA mode NOTE The USA operating modes are not outlined in the present manual Print out real time results with color When enabled the real time print out will be in colors otherwise it will be in black and white Print out real time results with final report When enabled it provides test results per patient in real time hard copy print out in report format Add to extra patients list If selected then one can choose to send patients to the list if it is not full or in any case amp Printer Header Footer Language Syste
196. ommand saves data into the patients archive Delete results This command deletes data It is password protected Exit Exits from data display page Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 13 of 16 RESULTS PER TEST fg 223000 Aix e CS i c X eco 9 CTRL6724 0 ln ee mg dl 5 03 43 0 102 V GLI Glicemia 3 0009457 80 0 mg L 6 93 35 0 96 5 Inserisci Routine STAT 51 0002151 i ee mg L 7 01 11 0 55 5 9 CTRL6724 31 9 mg L 8 86 27 0 82 5 3 0009457 72 4 ng dl 5 75 20 0 46 0 Inserisci Batch V GLU Glucosio Esecuzione 5 CTRL5496 52 4 mg dl 5 35 pazienti in attesa 9 CTRL6724 87 1 mg dl 4 21 14 0 54 0 3 0009457 46 4 mg dl 0 670 19 0 65 5 1 Ripetizione per 7 CTRL4251 64 5 UI dl 4 94 LIP Lipasi Cancella lista pazienti 51 0002151 50 7 mg dl 9 95 26 0 68 0 3 0009457 UI l 3 3 33 0 91 5 PRY 51 0002151 19 3 UI dl 9 41 10 0 71 0 H9 CTRL6724 0 ne eee mg L 3 93 55 0 103 43 0009157 2 mg L 3 56 38 0 97 0 7 CTRL4251 56 0 ug L 6 05 RAT 51 0002151 i ee UI l 4 87 46 0 119 9 CTRL6724 0 ln eee UI 1 2 11 43 0 98 5 3 0009457 89 3 mg dl
197. on Displays the first free position from the available positions To modify this field use horizontal arrows lt or type in the desired position Do not modify to accept Code It is the identification number assigned by the user to the patient The user can also enter the code of a patient saved in the work list even if in execution In this case a message asks the user to confirm patient s data cloning In case of affirmative response all the data relevant to the patient is instantly displayed and is linked to the current position The cloning of a patient s code allows the user to obtain one report in case different samples are used If this option is not used then separate reports are obtained Duplicate patient By clicking on the icon Figure 6 amp 6A it is possible to create a worklist with the same profile Autobatch or else a list with sequential codes When the patients are entered using the duplication method their codes may be assigned by the analyzer or it may be a progressive number In the case of progressive number the operator must enter the first code to be used Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page 7 of 17 Surname Name Enter patient s personal data Draw Date System date is automatically displayed To modify move mouse cursor on textbox click and edit Note Additional information to be added to the report External Diluti
198. on Factor By default set to 1 It allows analysis determination on externally diluted samples Enter in this field the external dilution factor ratio used in sample preparation Final result is multiplied by the inserted ratio NOTE If a hyper activity parameter value is surpassed indicated by an appropriate flag during determinations of externally diluted samples the Automatic Re run is not performed Test Generates the Analysis List Select each analysis to be performed on the sample Profiles Select Deselect Tests Profile The stored Profiles list Fig 7 is displayed through this command refer to Chapter C paragraph 1 6 Creating Profiles Two acquisition modes are available The first one requires a double click on profile s name The second mode after choosing the profile with one click requires confirmation by activating Select The analyses programmed in this way can be modified To add or remove tests it is necessary to enter in the screen Select tests and confirm by clicking on the textboxes With Deselect it is possible to delete an already selected profile Code Group i Type Assigned Group f Man Serum Routine C Woman Urine C CTRL Routine Surname C Child Draw Date External dilution factor 06 03 02 fi 00 Note ER IN ca Test B Profile E Delete E Save B Run Exit Availab
199. on I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 6 Page 4 of 20 By clicking the mouse over a given value in the graph its information will be displayed fig 6 Click on the Print button to print the graph Westgard graph Analyses Date Time BIC 222001 12 21 Method Level TRINDER 1 Type Figure 6 Known 23 0 Out of limit Westgard s Decision It is a procedure for classifying values of a Known lot taken into consideration for processing The following procedure is observed for classification Class A 1 2S A result exceeds Mean by 2S Class 1 35 result exceeds Mean by 3S Class C 2 2S Two consecutive results exceed mean by 2S in the same direction Class D R 4S Difference between two consecutive results is higher than 4S and at least one result exceeds mean by 25 Class E 4 1S Four consecutive results exceed mean by more than 1S in the same direction and at least one result exceeds mean by 25 Class F 10x Ten consecutive results are all in the same direction of the mean value and at least one result exceeds the mean by 2S Mean Mean range of the Lots S Max range Min range 8 Classes are controlled from F to A The classes are mutually exclusive that is if a given value is mapped to one class then it can t be part of another class Example 2 E classes means that 5 consecutive results exceed Mean by more than 1S in t
200. one of the patient The cloning of a patient s code allows the user to obtain one report in case different samples are used If this option is not used then separate reports are obtained It is also possible to create multiple duplicates of the same patient where the codes will be automatically assigned and identified by the name Autobatch These will have individual reports Surname Name Enter patient s personal data External Dilution Factor By default set to 1 It allows analysis determination on externally diluted samples Enter in this field the external dilution factor ratio used in sample preparation Final result is multiplied by the inserted external dilution factor Group Select the group Man Woman Child for correct reference with normal values range Type It is default set to Serum The sample type Serum or Urines is selected here If Urine is selected then the volume of diuresis in liters is requested Assigned Group Routine or CTRL Routine The default setting is Routine It is used for selecting the category Patient or Control Serum during sample programming Selecting CTRL Routine the type or Unknown and levels Level 1 2 3 must be specified Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 9 of 16 Position Displays the assigned position on the sample tray Test Generates the Analysis List
201. ons BT2000 PL Rev 0 Soft Ver 8 Page 28 of 31 Standard parameters for IGA LJ Fie calibration on single point Timed re run Automatic dilution 2 Dilution Dilution with solution To function standards pre dilution observe the following procedure Program the positions and enter the calibrator concentrations entire corresponding to the first desired m oelect the desired dilution ratio in Dilution field The calculated serial dilution starting from the entire standard will be automatically presented in the concentration fields Place on the serum plate one cup with the highest standard followed by some empty cups to be used for preparation of the serial dilution During the execution of test calibration first the standard dilutions are prepared and then the determinations are performed and at last the curves are processed The programming procedure is identical in the non linear analyses Log logit 4 amp 5 the required positions are 4 amp 5 respectively Note It is possible to perform normalization of stored calibration curves using only one calibrator Normalization procedure for the stored calibration curv 1 Re calibrating on single point zi n point fi e Sample position Last Standardization p 000 Reagent 5 lt Not Performed gt GF Timed e Print parameters Num
202. onsumables from the instrument test tubes cups bottles containers fluidic tubing etc and thoroughly clean the instrument with an approved disinfectant for decontamination 2 Contact a firm specialized in hazardous waste disposal for safe instrument disposal NOTE a The manufacturer of the instrument assumes no responsibility for any breaches resulting from the delivery of the analyzer to a third party for disposal b The manufacturer of the instrument is not responsible for collection and safe disposal of the instrument The safe disposal of the instrument and its contents is the responsibility of the user Section I Chapter K Warnings amp Precautions 2000 PL Rev 0 Soft Ver 8 Page 6 of 6 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATON CHAPTERL 1 MAINTENANCE AND CARE 1 1 Preventive maintenance and Extra Wash 1 2 Replacing tubing and accessories 1 3 Additional maintenances 1 4 Cleaning the instrument 2 MALFUNCTIONS 2 1 Troubleshooting 2 2 Screen messages 2 2 1 Screen messages Causes and remedies 2 2 2 Messages requiring technical assistance 2 2 3 Optical system verification messages Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter L Maintenance amp Troubleshooting BT2000 PL Page Page Page Page Page Page Page Page Page Page Rev 0 Soft Ver S Index ooh 1 MAIN
203. ooting BT2000 PL Rev 0 Soft Ver S Page 3 of 12 Normally the reading cuvettes should be substituted only if it is impossible to clean them properly or of they are damaged After substitution with new cuvette s it is important to perform the FCC procedure for the recalculation of the correction factor of the optical path If the FCC procedure is not performed then it may result in an optical transmission error of approximately 3 max After removing cuvette plate and then replacing cuvette s on the cuvette plate give it a final inspection to make certain everything concerning cuvettes cleanliness and integrity is satisfactory Gently place the cuvette plate downwards onto the rotor Be sure it is uniformly seated and secure all the cuvettes by gently pushing downwards until they bottom against the depth of the rotor Do not force the any cuvette into place in the cuvette plate use a light pressure with thumb Fasten the cuvette plate securely by tightening all the mounting screws To ensure that pressure is applied uniformly first tighten all mounting screws finger tight and then tighten them in a crosswise pattern Do not use excessive force on the screws NOTE The cleaning of cuvettes is of special importance and demands the complete removal of all contaminations from the inner surfaces If the cuvettes are not regularly cleaned then during the tests the slow release of contamination deposits from the inner surfaces may cause serious prob
204. or P1 must be extracted with the following procedure with N 3 1 Compute the Regression line y mX q from the reading points 2 Search for the point on the line at To with N 23 1 Compute Best Fit curve coefficients from the reading points 2 Search for the point on the line at To N number of points during reading time Normalization of reading data elimination of erroneous readinas for Kinetics and Initial Rate tests If more than two points are obtained during reading time then a If CC is gt 0 99 the procedure stops b If CC is lt 0 99 NN N 3 Compute linear regression and store m and q Compute the first most distant point from the line y mX q Trace the point on the line NN NN 1 If NN is gt 0 go back to step 2 where Correlation Coefficient N Number of points during reading time NN Number of points to be traced m Angular coefficient for the line q Known line coefficient Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 9 of 31 1 2 5 METHODS DESCRIPTION End Point Once the sample has been added to its reagent a reaction occurs first causing a variation in the solution s color i e the absorbance usually during incubation time followed by a phase in which the reaction s color is stable defined as plateau Generally the absorbance value A is read from the first point after the incubation time This value is then multiplie
205. ossible to set a pre dilution parameter that will be used by the analyzer when calculating final result For manually pre diluted samples if the result is hyperactive this will be checked with the appropriate flag but test won t be automatically re run The user has thus the opportunity to run the test again with an increased pre dilution for pre diluted samples manually or automatically The test results will be then checked with these parameters before calculating the dilution factor Note Reporting the first and second result when automatically re running pathological and hyperactive tests in case of automatic re running of hyperactive and pathological tests the analyzer displays and prints in real time a compressed report The report shows the results obtained from the first and second determination naming them first and second result However one should bear in mind that in the patients archive only the second result is stored the one obtained after the repetition 1 4 CONTROLS In the pages All Tests and Current Tray select desired test code then move the mouse cursor to the command Controls and click to confirm The parameters for the desired test are contained in the displayed page The controls are divided into Known and Unknown where it is possible to program three levels for each one subdivided in tables Known Level1 2 3 Unknown Level 1 2 3 Control parameters for XXX Control parameters for X
206. ounting of automatic execution time interval restarts Standards Controls and Patients Run The analyzer allows the associated running of standards controls and patients The standards on user s demand can be processed before during or after patients run These three options provide the analyzer with maximum operating flexibility To run calibrations during patients tests observe the previously outlined procedures After the termination of calibrations performed during the determination of the tests the successive test results are processed in accordance with the last calibrations The previous test results are processed using previous calibrations At the end of work phase it is possible to recalculate all the tests using the latest calibrations through the command Adjust followed by With Standard The command Adjust can be accessed through the page Available results real time results Refer to Chapter G paragraph 1 1 Displaying Patient Results For results calculation see Chapter C paragraph 1 5 Calibrations NOTE In case of analytical errors during calibrations the analyzer displays the error type and conserves the previous validated calibrations in the analyzer memory Section I Chapter E Operating Procedure BT2000 PL Rev 0 Soft Ver S Page 5 of 17 1 4 SAMPLES Entering Samples Routine STAT Controls and Batch Samples can be entered with Insert Routine STAT or with Insert Batch These can b
207. password CHAPTER F 1 QUALITY CONTROLS 1 1 Controls Inserting modifying controls 1 2 Displaying and processing by date 1 3 Displaying and processing by lot pairs Juden graph Westgard Graph Westgard Decision Daily Chart Graph 1 4 Additional Functions 2 POPULATION Analysis Selection How to run a Query Principal statistics formulas used in Population module Diagrams Inserting external analyses Other menu functions 3 PATIENTS ARCHIVE Selection How to run a Query Patient s report Printing Reports Other menu functions CHAPTER G 1 DISPLAYING AND PRINTING RESULTS 1 1 Results per patient 1 2 Results per test 1 3 Displaying real time data 1 4 Reaction Graphs 1 5 Flags List Index BT2000 PLUS Rev 0 Soft Ver 8 Page 2 of 4 Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page INDEX BT2000 PLUS Operator Manual CHAPTER H 1 ANALYZER TECHNICAL FUNCTIONS 1 1 Service Functions 1 1 1 Analyzer Utilities 1 1 2 Mechanical Calibrations 1 2 Diagnostic Functions 2 ANALYZER SETUP CHAPTER I 1 BARCODE AND RELATED FUNCTIONS 2 USING THE BARCODE 2 1 Barcode on Samples 2 2 Barcode on Reagents CHAPTER K 1 WARNINGS AND PRECAUTI
208. per minute AA min processing of the linear regression and computation of the concentration s value Initial Rate Reagents reading check Data detection during programmed reading time determination of the absorbance delta per minute AA min processing of the linear regression and computation of the concentration s value Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 13 of 31 Sample Blank A Reagents reading only for check R1 R2 first phase sample blank with reagent 1 and sample data detection at the end of incubation time 1 second phase analysis adding reagent 2 data detection at the end of incubation time 2 absorbance delta determination AA between first and second phase and concentration s value computation Sample Blank Blank Reagent R1 R2 first phase sample blank with reagent 1 and sample data detection at the end of incubation time 1 second phase analysis adding reagent 2 data detection at the end of incubation time 2 absorbance delta determination AA between first and second phase and concentration s value computation Sample Blank B Reagent s reading only for check with R2 Working Reagent first phase sample blank with reagent 1 and sample data detection at the end of incubation time 1 second phase analysis with reagent 2 and sample data detection at the end of incubation time 2 absorbance delta determination AA between first and second phase and concentr
209. r Power 35 Watts Input voltage 12 VDC Avg Rated Life Approximately 2000 hours NOTE For optimal result the lamp can be used for about 1 500 hours The long term use will result in the gradual deterioration of the UV emission DILUTORS Dilutors Type Biotecnica Dilutor TECHNICAL SPECIFICATIONS Max Volume 470 ul Linearity F S 0 1 Accuracy at 3 ul 3 Accuracy Full Scale 0 1 Reproducibility 0 7 at 3 ul 0 6 at 3 ul Average Life 3 million operating cycles Maintenance Every 300 000 operating cycles O ring seal replacement Section I Chapter M Technical Specs 2000 PL Rev 0 Soft Ver Page 3 of 4 VOLUMES WORKING SOLUTIONS Clinical Chemistry Reaction Volume Sample Volume 280 ul minimum 700 ul max double reagent from1 to 100 ul RESIDUAL VOLUMES OF REAGENTS BOTTLES 50 ml BOTTLES 20 ml BOTTLES 10 ml BOTTLES 1 ml 0 5 ml 0 5 ml UTILITY EXECUTION TIMES Wash amp Fill Up Wash H O Zeroing PO oe Extra Wash Cuvette Wash Shut Down WASH VOLUMES Clinical Chemistry Washes H20 Single Wash of Cuvette H20 Single Wash of Needle Consumption per test H20 for Zeroing H2O Total Wash of Cuvette Extra Wash of Cuvettes 2 0 seconds approximately 180 seconds approximately 420 seconds approximately 900 seconds approximately 540 seconds approximately 12 minutes approximately o ml approximately 2 ml approximately 7
210. r several analyses The creation of the current reagents list is automatic when the Bar Code option is enabled refer to Chapter The Relation Tests can be entered in the analyses tray They are placed at end of the generated list and no physical position is assigned to them Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 31 of 31 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER D 1 PERFORMANCE AND LIMITS Page 2 NOTE This manual is valid for both BT1000 and BT 2000PLUS The following components are not installed on the BT1000 a Reagent refrigerator b Barcode c Touchscreen d Cordless Keyboard amp Mouse Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter D Performance and Limits Rev 0 Soft Ver 8 BT2000 PL Index 1 PERFORMANCE AND LIMITS PERFORMANCE Operating Mode Random access Methods Tests for Clinical Chemistry and Immune Chemistry Test Mode Routine Batch Emergencies STAT Profiles Tests on line 48 refrigerated reagents Relation Tests Tests in memory 900 single or double reagent unlimited Relation Tests Test Reruns Automatic or on demand Calibrations and Controls Automatic or on demand Automatic Profiles Automatic execution of related profiles or on demand Measurement Direct reading of 25 cuvettes made of special optical glass Samples Tray Capacity 52 positions for Samples amp STATs 26 for
211. rammed Fig 17 and 18 The Serum card is displayed first To move between the Serum and Urine cards click on the desired tag The user can enter the following information Parameters for Clinical Chemistry XXX Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters Serum Urine Code xX BarCode Test methodology Method End Point 4 Kind of process 1st Filter 340 2nd Filter 700 ncreasing C Decreasing C None Reaction direction d Reagents E Sample E Times E gt isl Copy From Sample pl Print Dilution fi Pre Dilution 1 fi Post dilution 1 Figure 17 Serum Parameters Fig 17 Name Enter the complete name Primary parameters Check Parameters Secondary parameters Code px Bar Code Test methodology Method End Point Kind of process Li v 1st Filter 340 2nd Filter 700 Reaction direction ncreasing C Decreasing C None Serum Urine Save Pi Name Urine pl 3 Dilution fi Pre Dilution 1 fi Post dilution 1 4 Reagents E Sample gt Times E gt is Copy From Figure 18 Serum pl Sample volume expressed in ul 100 ul max Dilution In this screen two fields are available Pre Dilution 1 predilution ratio and Di
212. ration operating error generated by the system 0o o oC Refrigerator enabled Refrigerator disabled Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 5 of 16 1 2 INSERTING REAGENTS FOR CLINICAL CHEMISTRY Reagents status f m D E co C Less estes fees J er es el Check volumes mj Scan all battles Fig 3 This function can be accessed either by pressing F10 key or by clicking on the specific direct access icon It assists the user in correct positioning of the reagent bottles as programmed in the current tray The reagent tray accommodates five removable sectors identified by the letters A B C D and E Each sector has 8 positions The screen displays the representation of 8 8 reagent bottles Figure 3 The analysis codes that use large bottles are displayed in the lower positions while the codes using small bottles are displayed in the upper positions The insertion of reagents in the reagent tray for clinical chemistry is shown in Figures 4 amp 5 m WV ONSE i 7 Te I lt g Fig 4 Fig 5 Single bottle Right click over analysis code Choose between bottle s insertion or removal The analyzer will correctly position the tray to match with the arrow at the base of the tray itself With bar code option enabled identification is correctly accomplished through the automatic scan of the bar code on the inserted bottle
213. re will import all parameters and Single test imports single tests Analyzer Menu Fig 3 Analyzer s utilities Provides access to the service Analyzer Utility ExtemalPr Procedures of the analyzer Mechanical Calibrations For making adjustments to mechanical devices Mechanical Calibrations Diagnostic The technical assistance personnel mainly use this function see Chapter H Analvzer s utilities Diagnostic Figure 3 Utility Menu Fig 4 Archive Data This command stores the processed patients Utility External Programs data into the patients archive Archive Data View reaction s curves This command displays on a graph the view reaction s curves reaction s curves of tests with print capability View Results for analises View results for Analyses Displays results for test Setup Analyzer It is used to define some system parameters This command is disabled during analyzer operation Refer to Sleep Setup Analyzer in Chapter H paragraph 2 Suspend activity Logo Sleep This command sets the analyzer to a standby mode during which the cuvettes are washed and the monitor displays the screensaver Press any key to exit this mode then a reset will occur and the analyzer will be immediately ready to operate This option is Log Files useful when the analyzer is not being used for a while but it must be kept on to resume work immediately Se
214. rity condition hyperactivity With Re run hyperactive check enabled refer to paragraph 1 3 6 Automatic re runs the analyzer will automatically re run the test by pre diluting the sample in order to bring the reaction into linearity range The final result is automatically multiplied by the dilution factor and will be checked with I flag 7 Hyperactive Sample out of Test Limit Initial ABS mABS This parameter is used only for the methods Kinetics Fixed Time and Initial Rate t is expressed in mABS and defines the limit for the total absorbance reagent serum expected for this test The first reading of the incubation phase is compared with this value If the read value is greater than the parameter the analyzer will consider that as a possible interference of serum in the reaction for example lipemic serum thus marking the final result with flag Serum Interference Final ABS mABS this parameter is used only for the methods Kinetics Fixed Time and Initial Rate It is the last reading of the reaction expressed in mABS it indicates the limit upper limit for increasing analyses lower limit for decreasing ones beyond which the analyzer detects an out of linearity test hyperactivity With Re run hyperactive check enabled refer to paragraph 1 3 6 Automatic Re runs the analyzer will automatically re run the test by pre diluting the sample refer to Chapter E paragraph 1 4 Sampl
215. s Relation Tests with no limit In the stored analyses list the operator can generate customized test codes sequence of reagent plate in use including the relation tests During analyzer operation the refrigerated reagents chamber ensures a longer stability of the products in use positive barcode identification of reagents position eliminates any possible error during the positioning of bottles It is possible to perform repetitions upon operator s request or automatically pathological results n case of hyperactive results the test repetition can be performed with automatic dilution of the sample as programmed in the parameters page It is also possible to run tests on already diluted samples thanks to the automatic data processing function Random positioning of samples and positive barcode identification The bar code feature and the connection to the Host Computer allow the system to be fully automated An internal software manages the QUALITY CONTROL statistics of control sera and population and PATIENTS ARCHIVE with data display and printouts 2 Fas Patients Tests Analyzer Utili Patients Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 2 of 11 2 BASIC OPERATING PRINCIPLES OF THE ANALYZER The BT2000 PLUS is an automatic analyzer based upon the spectrophotometry principles The light absorption laws rule the performance of spectrophotometers
216. s Used for linear reactions It requires analytic calibration of the test Processes the passing line for two different concentrations Represents FACTOR SLOPE and INTERCEPT SHIFT FILTER The operator can select the desired filter value for the 1st Filter and the 2nd Filter reference filter from the available filter wavelengths 340 380 405 436 480 510 546 578 630 700 nm Figures 14 and 15 For the tests in bichromatism click on the 1st Filter and select the desired filter value from the cascading window and then go to 2nd Filter and select the desired filter value from its cascading window 1st position has empty field For the tests in monochromatism select the desired filter value in the 1st Filter cascading window Since the second filter is not used in this test therefore select the first position empty field in the cascading window of 2nd Filter Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters Primary parameters Check Parameters Secondary parameters Code Code x Bar Code B Prin Test methodology Test methodology Method Method Reagents E d Reagents E l Sample E sx lg Sample E OQ Ime E st Filter nd Filter 7 Reaction directi ncreasin mi Copy From ial Copy From Figure 14 Figure 15 Reaction direction select the kind of ab
217. s E i Gert utan Reaction direction ncreasing C Decreasing EN Copy From Reagent 2 C None Figure 16 Volume ul enter the reaction volumes for each reagent expressed in ul selecting the corresponding tag Reagent 1 and Reagent 2 see Fig 16 Always bear in mind that the minimum volume for the final solution reagent sample is 300 ul while the maximum allowable volume is 700 yl Concentrated this field refers to concentrated reagents If ready to use reagents are used this option should be disabled If the program for volume of the Concentrated is enabled then insert in the Volume ul text box the volume of the concentrated reagent that the analyzer will withdraw for sampling select the type of diluent to be used if double distilled water Dilution with water or dedicated diluent Dilution with solution Write in the apposite field ul Diluent the volume of diluent to be added to the concentrated reagent For example for a dilution ratio of 1 2 write 100ul for the concentrated reagent and 200ul for the diluent The dedicated diluent is considered by the analyzer as a further reagent and will therefore take a position of its own the reagents tray If the diluent is the distilled water the analyzer will take it from the main reservoir Sample clicking on the button will open the window where sampling parameters for Serum and Urine can be prog
218. s codes pertain to the list generated in the Current tray To run standards and controls select the desired tests and then click on the Run button To leave program press Exit Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 7 of 16 1 4 ENTERING PATIENTS AND WORK LISTS Entering Samples Routine STAT Controls and Batch Samples can be entered with Insert Routine STAT or with Insert Batch These can be accessed from Patients main menu or through appropriate direct access icons Select Exit to leave the program The represented analyses codes pertain to the list generated in the Create current tray Entering Patients The options outlined below are available in this page Global Insert View Patients Figure 13 Point the cursor on the desired option and click to confirm To leave program press Exit MIS P Gee E 8 cw E Re run Routine STAT Control Standard New Entry Extra Patients Routine 1 ions Direct access icon ES le H le E L5 fed El il 13 15 17 19 21 23 25 27 29 31 33 35 37 33 41781787370 Figure Re run allows tests re run repetitions on user s demand Routine Default displays of Patient positions STAT Displays STAT Single Test in Actua
219. s possible to set an automatic execution of calibration of a selected analysis commonly used for Linear and Non Linear analysis At the programmed standardization time out the analyzer will alert the user through a message and if the reagents and standards are present then one can directly perform the calibration Check the Timed re run box and enter the standardization time in the Time selection field It is possible to enter the intervals of days or hours Each daily interval Select the function and set interval days then enter test running time for example 1 08 30 means every day at 08 30 or in any case at start up Every hour interval Select the function and set the desired interval hours and minutes At the end of programming press Save to store data Press Exit to leave the program and not to save any eventual modifications Standard parameters for BIC Range limit Factor Minimum Maximum Calcula 1069 fico it Number of samples Var 10 O Timed re run o Last Standardization Reagent 5 lt Not Performed gt L8 f Pos Cone 200 ABS 0 000 fe q from last calibration e View used positions Linear Print 1 Enable Auto Adjust Save 9 Cancel Figure 26 r Calibrators or standards used must be placed into dedicated positions on th
220. ser during input The relevant group level is also indicated see Chapter F paragraph 1 Quality Controls c Surname Name Patient s personal data d Sample Type The relationship of Sample to one of the groups Routine STAT CTRL or STD is indicated between brackets e Results Tests results for a given patient are displayed indicating extended name of the analysis test methodology normal values range and any eventual warning flags see paragraph 1 5 Flags List For automatic repetitions the values for the first and second determination are shown NOTE The information regarding calibrations such as computed factor values and any eventual errors that occurred during execution standardization are shown in the data display page The following commands are available in the data display page Print Sort Adjust Archive Data Delete results 87 Exit Print Print command It allows two options Normal print out will print the pages as they are displayed i e samples will be printed sequentially or Print out for sample will print one single patient for each page Sort Data sorting command This function is enabled only at the end of working session The real time data are displayed in random order as the analyzer returns them The Sort command allows rearranging of data by test sequence start time Adjust Data re reprocessing command This function is enabled only at th
221. sorbance variation to be checked during reaction The following choices are available Increasing Decreasing None Selecting None excludes the possibility of controlling the reaction direction and in addition no control is performed on the flags of ABS Limit and out of range reagents This function is useful when testing new methods Select correct option so that the parameters later described Final ABS Initial ABS and Reagent Limit have the necessary reference with reaction progress Reagents click on this button to select the reagents parameters Fig 16 The user can enter the following information e Number of reagents Enter the number of reagents the methodology requires max 2 Use up down arrow keys or move the cursor directly on the box and enter the value Insert the volume of each reagent by selecting the corresponding table Reagent 1 amp Reagent 2 see Fig 16 in accordance with number of reagents programmed Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 19 of 31 Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters Code Bar Code Test methodology Method End Point Kind of process Linear v 2 si Number of reagents Reagents p W Sample E Volume pl 1150 L Concentrated s DGIO WAE 1st Filter 2nd Filter te Duhon Sr 340 700 2 Time
222. ssing reagent is interrupted It is possible to run missing tests using the rerun commands Chapter E paragraph 1 5 This message appears when the vacuum pump inside the analyzer has lost efficiency and the vacuum level is below 40 millibar It is possible to continue the tests if the vacuum level is 35 millibar and by setting the minimum threshold in the setup to 20 millibar If the problem persists contact nearest sales service department Whenever the external waste container is full the waste probe level detector transmits the relevant signal to the analyzer If the waste container is replaced within 60 seconds the analyzer operation is not interrupted if otherwise the analyzer interrupts sampling until the system Is reset The message No Water appears when washing water does not reach the analyzer because the external water container is empty or defective loading pump When this message is displayed the sampling procedure for programmed tests is stopped Fill the external water container to continue the tests Check replace if necessary the tubular filter on the intake tube inside the water tank item b paragraph 1 3 The analyzer will start working from where it stopped see Chapter E paragraph 1 5 If the error message persists because of defective loading pump contact the approved technical assistance The message Extra wash is displayed during normal working sessions when the analyzer has been previous
223. st enter the total reading time in seconds keeping in mind that the analyzer performs reading every 10 seconds The possible values range from 0 to 990 s Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 21 of 31 1 3 4 CHECK PARAMETERS Parameters for Clinical Chemistry XXX Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters z Primary parameters Check Parameters Secondary parameters Normal range Serum Normal range Min Max a Min Max 0 000 Reagent limit m4BS 0 000 0 000 0 000 Reagent limit m4BS 0 000 0 000 Man D Prin 100 Curve Acceptance 2 0 000 0 000 Woman 100 Curve Acceptance 2 0 000 0 000 Woman Serum Urine 0 000 Child Serum Urine 0 000 0 000 Child 0 000 e tun hyperactive fez Profile 0 000 O Re tun hyperactive Prae Test limit Test limit ae Wie oe ECR Pie run pathological 5 Profile 4 Re tun pathological yo Prof acon Re un pathological aati Initial ABS m amp B5 range ches Initial ABS m amp B5 ani 3000 Final ABS mABS Iden 2000 Final ABS mABS 2000 Max ABS Delta m4BS nic range Min Max 0 000 0 000 e 2000 jooo 0 000 Woman Max ABS Delta mABS 0 000 Woman M Check Prozona M Check Prozona Enable no ooo po fia mABS fio mABS Figur
224. st sales service office or directly to Biotecnica Instruments S p A Rome Italy After appropriate evaluation Biotecnica or its branch office will provide the best solution to the problem 1 2 INSTALLATION The analyzer must be placed on a stable vibration free surface level table or cart It should be easily accessible to the operator to load samples consumables reagents etc Ensure that the table can bear the instruments weight 85 Kg and is large enough for its dimensions refer to Chapter O paragraph 1 Technical Specifications Avoid exposure to direct light heat air streams and draught The instruments left right and rear sides must be left free min 20 cm from the wall to ensure the produced heat dispersion and easy tubes and cables connection Room temperature must not exceed 32 C We recommend placing on the same table the analyzer and its peripherals max allowed distance 1 5 m The vacuum system must be placed under the table in a position that allows its comfortable use and the easy connection of the waste tubes to the waste chambers The printer can be placed in any location always taking into consideration the paper feed the connections with the instrument and the power supply needs It is very important to place the analyzer away from strong electromagnetic fields such as centrifuges electric motors big refrigerators X ray instruments etc The table must be near a wall outlet with earthing and differential switch
225. t E LS LS es 49 50 Deselect Figure 10 Batch Entry Click test code then click each desired position selected positions are highlighted in red Finally click on the checkbox by the code to activate the programmed batch Select the Run button to perform the patients Refer to Fig 10 Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 10 of 16 Work Lists eG wis zs Patient Performed patients Routine Current Tray Routine Extra Patients Routine Options Options EJ AUTOBATCHOO3 AUTOBATCHOO04 qn 11 NENNEN d d dj dj dj dj i S E E ERES E FA E E ESI ESI ESI Fr Fn ES E 87 m Li a a m Li a m SEI Figure 11 Work Lists Figure 11 are used to display the patient codes or to verify the status of the samples in the tray together with the situation of Routines STAT Controls and Calibrators The Work Lists can be accessed through the menu Patients Insert Routine STAT or using its direct access icon The screen displays the Current Tray Routine in the center and the Extra Patients Routine on the right During the working phase the Re run is also shown The Options menu is available in the Current Tray Routine STAT and Controls It displays various commands outlined in the following paragraph 1 5
226. t in this case confirmation is required After the insertion of all the samples activate Run Delete Removes selected or all the patients Confirmation is required 1 6 DISPLAYING AND PRINTING RESULTS Displaying Patients Results The representation of the test results can be accessed through the specific 4 icon shown on the right for the two available options View results for sample results will be displayed for patient and View results for test results will be displayed for test a t H7 CTRL9413 Lanti David Control Unknown Level 2 lt Trinder gt 8 68 UI l i 8 47 Glicemia lt Color gt 94 9 mg dl i 2 lt Trinder gt 33 9 UI dl 3 60 VED lt gt 43 2 mg dl 5 18 RAT lt Color gt 66 0 UI dl 4 28 Bilirubina coop 24 4 UI dl 8 08 PRY lt Color gt 12 7 UI dl 1 56 BID 35 0 UI l 0 890 Glucosio 39 9 mg dl 2 33 Colesterolo 6 79 UIZL 9 13 w 52 0003894 Claro David STAT Glucosio lt Color gt 26 1 giai Si 115 Lipasi lt Trinder gt 41 8 mg dl 4 65 33 0 61 5 PRY lt Color gt 82 4 mg dl 8 02 49 0 115 VED lt Trinder gt 02 9 mg dl 7 04 54 0 98 0 FAC lt Color gt 4 67 mg L 4 57 20 0 78 0 w 51 000653 Rossi Matteo STAT BID lt Jundrassik gt 41 0 mg dl 0 900 42 0 99 0 f t H3 0008117 Barnard Fabio Routine Glicemia lt
227. tch the data length If the length of the numerical values is less than the data length then a series of characters 0 will be added to the left to reach the preset data dimension In case the length of the numerical values string is longer than the data length then the string will be truncated to match the data length It is not possible to use variables as parameter Length Example Stringn Hello Word 40 Stringn Variable1 0x10 Char Identifies a single character or single byte Set syntax Char lt Character gt Example Char H Char 20 Char 0x10 Char STX Identifies the beginning and the end of the group of repetitive commands syntax Set Begin lt Name of group Begin repetitive group Set End lt Name of group End repetitive group Note Actually the ANALYSESDATA is the unique SET present which identifies the analysis in transmission reception Only one command SET BEGIN and one command SET END can be present in a script A script must always contain the command SET The variable PATIENTNUMBERTEST must be present before the command SET Section Chapter 4 Serial Communication BT2000PL 0 Soft Ver S Page amp of 16 COMPILATION ERROR One or more errors due to incorrect script writing or the system error may show up during compilation of a script The compiler shows the error code the description of error and the line where it has been detected The following table shows the
228. tem The closed system means the exclusive use of reagents with special barcodes provided by the instrument manufacturer The barcode reading provides positive identification of the bottle with all the information regarding the reagent bottle small or large bottle volume expiry date and the lot number The instrument can also work as an open system after an agreement with the manufacturer The open system allows total exclusion of the barcode or the reading of analysis code only CAUTION For reagents bottles only the EAN 13 format labels are used The manufacturer provides the identification code directly on the bottle The reagent placement can be at random During the scanning the analyzer stores the newly generated map It is highly recommended to observe a systematic positioning of reagents in accordance with the problems of the contamination Some highly aggressive reagents may generate a carry over problem causing contamination phenomena in the successive tests Check volumes This command allows measurement of the volume of the reagent bottles refer to Chapter E paragraph 1 2 Reagents insertion and removal With reagent barcode enabled it is also possible to check the actual position of all the bottles in tray At the end of the reagent scanning the analyzer sorts codes disposition and provides a list of all the errors found during reading phase In case of detected anomalies the procedure can be repeated once t
229. ter B paragraph 1 3 Starting the instrument This operation turns on only the refrigerating system for the reagents To properly turn on the analyzer momentarily press the pushbutton located below the LCD display Chapter B Figure 11 Remember that if the same pushbutton is pressed again it turns off the analyzer leaving only the refrigerating system on After this initial phase of power on it will be necessary to enter the password see paragraph 1 7 ACCESS PASSWORD in this chapter After the turning on procedure lasting approx 1 minute allow the analyzer to warm up The instrument is ready for use after about 20 minutes when the temperature in the cuvettes tray has reached the proper value and the photometric lamp is stable 1 2 REAGENTS INSERTION AND REMOVAL Reagents status hex bi D ce rt wv Scan all bottles Figure 1 This function is accessed either by pressing F10 key or by clicking on the specific icon It helps the user to correctly position the reagent bottles as programmed in the current tray The reagent tray is divided into five removable sectors identified by the letters A B C D and E Each sector has 8 positions The screen displays the representation of 8 8 bottles Figure 1 The analysis codes of large bottles are displayed on the lower positions while the upper positions indicate the codes used for small bottles including the volume status for the sample diluent The symbols
230. the safety and warning precautions must be observed as outlined in the preceding paragraph e The exterior of the analyzer casing may be cleaned periodically to remove dust grease and other contamination It is not necessary to clean the inside Use soft cloth dampened with a mild solution of detergent with water e The owner shall be responsible for maintenance of the analyzer Wear or damage caused by lack of normal maintenance or by misuse of the analyzer shall not be considered as defective workmanship and material Section I Chapter K Warnings amp Precautions 2000 PL Rev 0 Soft Ver 8 Page 2 of 6 1 2 WARNINGS AND PRECAUTIONS The following warnings will aid the user to provide adequate safeguards to assure safe trouble free performance 1 10 11 12 13 BEFORE OPERATING THIS SYSTEM BE SURE TO READ THE OPERATOR MANUAL THOROUGHLY AND CAREFULLY AFTERWARDS KEEP IT HANDY FOR FUTURE REFERENCE TAKE SPECIAL CARE TO FOLLOW THE WARNINGS AND CAUTIONS INDICATED ON THE SYSTEM REAR PANEL AS WELL AS IN THE OPERATOR MANUAL SYSTEM S USE SHOULD BE RESTRICTED TO LAB S QUALIFIED PERSONNEL ONLY SLOTS AND OPENINGS IN THE CASE BACK PANEL AND BOTTOM ARE PROVIDED FOR VENTILATION THIS ENSURES RELIABLE OPERATION OF THE SYSTEM AND TO PROTECT IT FROM OVERHEATING DO NOT BLOCK OR COVER THESE OPENINGS BEFORE USING THE SYSTEM CHECK THAT THE VOLTAGE ON THE REAR PANEL LABEL MATCHES THE LOCAL LINE VOLTAGE TO GUARANTEE SAFE
231. tive Sample out of Max ABS Delta e Check Prozone mABS this parameter checks the ABS variation tendency during all processing time of the test In case of inversion it is likely to be in a Prozone situation The final result will be checked with C flag This parameter is used for all methods except for Reading only and indicates the maximum allowable inversion variation expressed in mABS e Note The parameters Test limit Initial ABS Final ABS Max ABS Delta and Check Prozone are different for serum and urine see Fig 19 and 20 1 3 5 SECONDARY ANALYTICAL PARAMETERS Parameters for Clinical Chemistry XXX BA Primary parameters Check Parameters Secondary parameters Serum Urine 1st Unit x ERG 2nd Unit ono Dynamic Blank Number of needle washes fi EH Number of cuvette washes Shift 0 000 Instrumental Factor 0 000 Reagent Blank Every run Decimals Every day C Automatic 9 up Hour Custom Hour Minute 0 22 zi vv Figure 22 After selecting the Secondary Parameters Figure 22 to program click inside the desired parameter textbox and confirm The user can enter the following information 1st Unit Enter the measurement unit in this field Click on the 2nd Unit to enable it for the second unit of measurement Instantly a new textbox will appear where the operator can type in the second unit of measurement
232. tore Backup Exit Utility Hew Record Delete Record s Select Analysis select Method Group Test Type Date Range selected DUM From To Delete Analysis Male Serum 03 03 2003 04 03 2003 uis Female Urine Results Range From Ta Child Relation pd Format Floppy DOM results for male serum with method M D and within the date and results ranges will be deleted Delete Archive this command will delete the whole archive no matter which selection has been made Format Floppy used to format the floppy disk Delete Archive Section I Chapter F Quality Controls 2000 PL Rev 0 Soft Ver 8 Page 13 of 20 1 5 PATIENTS ARCHIVE File Utility Delete SendtoRS232 Help Choose Date Choose Code Ch Select Select All sel Select All sel Choose Surname cs Select All Test Date Arrangement 1 C Code Figure 22 The Patients Archive module displays patients information and allows report printing It is also possible to display select and print external data that was previously saved on external files This software module is independent from the operating program for running analyses Its main features are 9 9 9 9 Displaying as well as data acquisition from updated analysis file Innternal archives update Internal and external archives display Cancelling of analyses files Dynamic query that allows sorting order
233. ts the window s contents i e parameters graphs etc alli Reduces the window to the upper bar where the analyzer s name appears Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 6 of 11 An icon representing refrigeration system operation has been added to the status bar in the main menu The Refrigerator disabled state may be necessary if the operator decides not to use the refrigerator for reactions or after a refrigeration operating error generated by the system 30 12 20 0c Refrigerator enabled Refrigerator disabled IVD SYMBOLS PRINTED PACKAGING ITEMS N Caution consult instructions for use In vitro Diagnostic Medical Device Catalog number lt Manufacturer Lot number or Batch code p4 Storage temperature Expiry date Biological hazard Risk symbols C 4 CE Logo Directive 98 79 CE Section I Chapter A System Description BT2000 PL Rev 0 Soft Ver 8 Page 7 of 11 SYMBOLS APPLIED ON THE ANALYZER A compilation of the main nameplate and warning symbols used for the IEC standards based on Table 1 of IEC 61010 1 Second Edition Direct current Alternating current Both direct and alternating current Earth ground Terminal Protective earth conductor terminal Frame or chassis ground terminal Equipotentiality ON Main supply C OFF Main supply Equipment protected by double insulation or reinforced insulat
234. tup Analyzer Shut Down Figure 4 Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 3 of 31 Note The analyzer switches automatically to standby mode when left unused for more than thirty minutes Suspend activity Log Off This command is used for programming the power on of the analyzer on a specific date and hour A small window will appear on the monitor where the restart time and date can be set After the programming is confirmed a guided procedure will lead to the system s washing procedure and afterwards the analyzer will suspend its activity The system will be off except for the reagent refrigeration chamber At the expiry of programmed time and date the analyzer will exit the sleep mode by performing a system reset To resume the analyzer activity before the programmed time press any key The system will reset and after approximately 20 minutes warmup time the analyzer will be ready to operate Shut Down To turn off the analyzer it is important to observe the shutdown procedure refer to Chapter E paragraph 1 6 The program through a guided procedure will perform the shutdown wash and then the computer will turn off leaving only the reagent refrigeration chamber turned on Press the ON OFF button on the rear panel to turn also the refrigerator off Note The analyzers program will guide the operator through screen messages in the analyzer turning on and turning off procedures He will be invited
235. ty Figure 14 Chapter H Analyzer Technical Functions BT2000 PL Passwords This function is for personalization of the passwords that grant access to program levels 2 and 3 Fig 14 This operation is reserved for specialized personnel only Rev 0 Soft Ver 6 Page 9 of 10 Audio Engine To activate the Audio Engine Figure 16 go to Utility Setup Analyzer System Figure 8 15 Voice choose Present and click adjacent button Figure 15 This option permits audio volume regulation and the velocity of audio reproduction If audio volume regulation and the velocity of audio reproduction is not required then select Not Present Language System Printer Icons v Visible Invisible Click this button to A E activate Audio Engine f Present C Mat Present Figure 15 Audio Engine Select Audio Engine x Test Test String Speed Volume Figure 16 Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver 6 Page 10 of 10 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATION CHAPTER I 1 BARCODE AND RELATED FUNCTIONS 2 USING THE BARCODE 2 1 Barcode on Samples 2 2 Barcode on Reagents NOTE Page Page Page Page This manual is valid for both BT1000 and BT 2000PLUS The following components are not installed on the BT1000 a Reagent refrigerator b Barcode c Touchscreen
236. ull meaning of each command will be explained in the corresponding chapters At the start up the program will display the following main window o atients Tests Analyzer Utility External Programs 0000000000000 0 Q Insert Routine STAT Insert Batch Run all pending patients Repetition for analyses Clear Patient List Program Code 8 2 5240231 41229 Access level 100 MASTER 9 13 2004 9 32184M 26 C 37 0 C 93 mBar Main menu each menu generates other commands and or options Direct access icons selecting each icon the relative command is directly activated Software version operative program version Access level is the access level of the operator it is password dependent Vertical Bar Commands Direct access to function commands Messages bar clicking here opens a window showing the messages received by the program Errors bar by clicking here a window is opened showing the errors occurred during the work session Refrigerator Status Indicator Indicator for Operating Pressure Ambient Temperature RT Cuvette Temperature CT QQO 69 G0 Section II Chapter 1 Abbreviated Instructions BT2000 PL Rev 0 Soft Ver 8 Page 2 of 16 1 1 TURNING ON AND PRELIMINARY PROCEDURES 1 Check that the UPS device is turned on 2 Check that the printer is on and that there is enough paper in the tray 3 T
237. unction To enter a simple mathematical function avail yourself of the calculator To enter a complex function select the code of the test to be inserted into the function A small field will appear where it is possible to select between serum or urine results for that test Then complete the function with the needed operations Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 8 Page 16 of 31 To create more complex functions involving more than one test s result it is advisable to use the parenthesis as for all normal mathematical functions Ex For the creatinine clearance with urine 24h 900ml urine CRE x urine ml 24 h serum CRE x 1440 the formula would be CRE amp U 900 CRE amp S 1440 The button Test Function Fig 10A is used for checking the relation test result from the analyzer based on values given to the tests involved in the function This option is useful for verifying the correct use of values and parenthesis in the formula The other options Figure 9 available are Save saves and exits from the window Print prints parameters Cancel exits without saving Note The relation tests can be inserted into the available analyses list for the current tray even if they have no determined reagent position refer to paragraph 1 7 Modify Current Tray The result for a relation test can be returned only if both the test itself and all the other analyses involved in the function are pres
238. ur care and maintenance program CAUTION a Completely empty hydraulic circuit using the program outlined in the Chapter H paragraph 1 1 Empty Fluidics and wait until this operation terminates b Always make sure that the mains power switch on the instrument is turned off and the power cord is unplugged from the wall outlet before performing any maintenance procedure 1 Replace the worn out component soon after the on screen message from the maintenance software has been displayed Figure 1 Show Diagnostic To access this function refer to chapter H 2 Any consumable part showing signs of wear or damage should be immediately replaced even if the appropriate on screen message is not already displayed 3 Use only original Biotecnica parts Do not replace defective parts with non original parts as this will cause malfunctioning of the analyzer In case of any doubt contact the Biotecnica Instruments S p A or nearest service center 4 Use only bi distilled water for the washes performed during working phases 5 Use only Biotecnica Instruments S p A approved wash solution for the washing procedures at the end of working session 6 During routine maintenance exercise extreme caution to avoid any contamination When replacing tubing needle or handling waste container etc accidental contact with organic liquid is possible For individual safety use suitable protective garments such as overalls and gloves refer to
239. urve by means of several standards at different concentrations 1 2 1 COMPUTATIONS COMPUTING ABSORBANCE ABS End Point ABS Mean value of the last points in reading time max 3 With subtraction of the Blank reagent Kinetics e Linear regression computation e ABS straight line coefficient x 60 sec Fixed Time ABS A ABS last reading first reading Initial Rate e Linear regression computation e ABS Straight line coefficient In case test is unstable e Linear regression computation e Elimination of 49 of the most distant points from the straight line e ABS re computation Sample Blank A ABS Last reading of the second phase last reading of the first phase x K K Volumetric factor Section I Chapter C Functions BT2000 PL Rev 0 Soft Ver 6 Page 5 of 31 Sample Blank B ABS Last reading of the second phase last reading of the first phase End Point 2 Points If readings are more than 3 e L1 First reading e 2 Mean value of the last 3 readings If readings are more than 2 e 1 First reading e 2 Mean value of the last 2 readings Otherwise e L1 First reading e 2 Last reading ABS L2 L1 Sample Blank A b Blank R1 R2 1 phase R1 Serum 2 phase R2 Computation Reading 2 phase Reading 1 phase blank Sample Blank B b Blank R2 1 cuvette R1 serum 2 cuvette R2 serum Computation Reading 2 cuvette Reading 1
240. uter Click Y to view all the possible transmission speeds To select click on the desired value Hand Shake Enables Data Flow Control to be used during data transmission Click Y to view the available options To select click on the desired option All results must be sent automatically without validation When this option is enabled all results from the analyzer are sent automatically and immediately to the host computer If the option is not enabled then the operator decides when to send the data see Chapter C paragraph 1 1 Description of the program Menu Analyzer will display the following options for sending patients to the host computer accept results to be sent or delete results to be sent see Chapter E paragraph 1 5 WORK LISTS Section I Chapter H Analyzer Technical Functions BT2000 PL Rev 0 Soft Ver S Page 8 of 10 Cuvettes Temperature C Room Temperature C 30 C Language System Printer Header Footer Bar Code Serial Working Temperature Samples Tray Passwords 4c Set up pressure Minimal pressure 20 x Reagent refrigerator Enable Reagent Refrigerator 8 zi Temperature Reagents refrigerator Setup Utility Figure 12 Ce Number of Routine 2 Number of STAT 20 4 Number of Standards ic Number of Controls 1 50 51 52 1 20 21 26 Setup Utility Figure 13 Working Te
241. ve sector After the choice has been made the analyzer will correctly position the whole sector for insertion or removal The verification of fluid Scan sector volume contained in the bottles is associated with the sector insertion procedure With bar code option enabled identification is correctly achieved through the automatic scan of the bar code of the inserted bottles The same function can also be performed on command through Scan sector near the sector insertion and removal commands Insert sector Remove sector Scan all bottles Enabled only when barcode option is on It automatically performs the correct identification of all bottles positions Move cursor to this command and click Check volumes This option checks on users demand the volume contained in all the bottles that are placed on the tray Click with mouse on this command to confirm Volume s information By clicking on the each analysis code the volume of the reagent contained in the bottle is displayed as well as the number of tests that can be performed with it Figure 2 information Volume ml Num Samples Mas Samples Figure 2 2 Single reagent bottle Right click with mouse on the desired bottle representation Figure 1 apne a screen appears with options Insert bottle and Check volume j After selecting the option for example Insert bottle the analyzer will verify the volume contained in t
242. very aggressive tests more washings will be necessary To set washing number max 9 required by the contaminating force for the used product press or move the mouse cursor over dedicated box and enter directly the value With this command the user can set the number of washings for the cuvette used by the current analysis before making it available to other tests In practice the analyzer verifies and selects from all the cuvettes that have terminated analysis the one that requires minimum number of washes e Reagent Blank Timing This parameter is used for automatic determination of the ABS value for the reagent Select among available choices present in the Reagent Blank timing list see Fig 22 one of the following Every run The absorbance determination for the reagent will be performed at work start up Every day The absorbance determination for the reagent will be performed once a working day when the first working list of day is started up Hour The absorbance determination for the reagent will be performed at the time intervals as programmed into the Hour and Minute boxes For example setting 02 hour and 00 minutes determination will be performed every two hours To set the value press or move the mouse cursor inside the dedicated box and enter directly the value e Decimals If this parameter is used with the Custom then it sets the number of decimal
243. will not be compiled but will serve as note only for the programmer These are particular sequence of characters preceded by the symbol which will be used by the program for storing internal information patient code analysis name and etc refer to TABLE 1 TRANSMISSION RECEPTION There are also variables for direct uses which allow for identification of any character below ASCII 32 space to facilitate the writing of the script for example one can use the variable EOT to identify the character 4 see TABLE 2 INTERNAL VARIABLES SCRIPT FUNCTIONS String Identifies a string of variable length ending with a particular character syntax String lt string gt l lt Terminator gt Where lt String gt Transmit receive string lt Terminator gt End character Note It is not possible to use the variables like parameter Terminator Example String Hello Word 0 String My String String Variable1 0x10 Stringn Identifies a string of fixed length Syntax Stringn String Length Where String Transmit receive string lt Length gt String length Section Chapter 4 Serial Communication BT2000PL 0 Soft Ver S Page 7 of 16 Note If the length of the text strings is less than the data length then a series of spaces will be added on the right to reach the data preset length In case the text string is longer than the data length then the string end will be cut off to ma
244. ws the following functions Send to Current Tray The selected patients are removed from Extra Patients List for placement on current samples tray list Selection can be done by checking the appropriate boxes Use Select to select the whole list and Deselect to deselect it The confirmation is required Print Prints the selected or total samples list Delete Removes selected or all the patients Confirmation is required Performed Patients List This list displays the codes and positions for the completed patients that are available for repetition The user by double clicking on an active code enables patient s information page with assigned analyses and relevant results while by clicking on a given analysis code the reaction graph is presented To re run the desired patient code must be transferred to Current Tray List and then run again Confirm with a single click on the position confirmation is requested before transferring If the answer is positive then the screen Select Repetition Position is displayed If available the previously used position is shown otherwise the first vacant position is presented modify if necessary Once the position is confirmed or modified Registry Situation with related analysis is presented Deselect the analysis that should not be repeated add new tests if needed Once programming has been terminated confirm with command Run to run the sample or save
245. xtreme care during analyzer operation and especially when working close to the devices To avoid accidental contamination use suitable guards and or personal protection such as overall and gloves When handling reagents it is advisable to observe good laboratory practice GLP rules Chemicals serum samples and reagents must be handled with extreme caution Patient samples may be biologically hazardous The reagents or any other substances that may enter in contact with samples should be treated in the same way as samples themselves The materials of human origin such as control sera are tested for the detection of HbsAg anti HCV anti HIV 1 anti HIV 2 antibodies Even if the result is negative as no known analytical method can exclude any infection s risk with certainty therefore these materials must be considered as potentially infective and thus must be handled with extreme caution The reagents and any other substance entering in contact with samples must be treated in the same way The reagents must be manipulated before during and after the use by qualified personnel familiar with their characteristics in order to safeguard the user as well as the quality of the reagent itself MAINTENANCE e It is of extreme importance that the instrument is fully turned off and the power cord unplugged from the wall outlet to safely perform any maintenance or service procedure e During maintenance procedures see Chapter N Maintenance
246. y Controls 2000 PL Rev 0 Soft Ver 6 Page 15 of 20 Codes Selection Insert Initial Code Insert Final Code amp accen 8 Cancel Codes Selection It is possible to enter the information regarding the search range for desired analyses codes by clicking on the icon hand next to Choose Codes The search is case sensitive meaning that the system distinguishes the capital letters Upper case letters from the small letters lower case letters Clicking on the button Accept will save the values entered Figure 25 in the editing fields Insert Initial Code and Insert Final Code Pressing of Cancel will cancel the operation of the codes selection Name Surname Selection click on the hand icon ELE corresponding to Choose Name or Choose Surname Fig 23 to open the Name Selection window for seraching by name or surname Write name or surname in the dedicated field and click Accept to save the name or surname for NI search or click Cancel to abort the operation Figure 26 Patients Report View Analyses In this page Figure 27 it is possible to view the test results of a selected code Results for 04 03 2003 Code 0001431 Surname Rossi Roberta 04 03 2003 Male Notes mL dal Sendto 5232 Questa amp una nata abbastanza lunga BD a Date Group amp Previous
247. ying and Printing Results BT2000 PL Rev 0 Soft Ver 6 Page 6 of 7 1 5 FLAGS LIST The analyzer uses flag symbols to properly check analyses result These symbols are printed in the report adjacent to the result The following priority exists for the flags indicating hyperactivity Test Limit A Reaction Limit d Max ABS Delta The flags and their meanings are tabulated below S UY Unstable sample C C greater than assigned value Sample above Calibration curve Sample above Calibration curve after repetition Sample below Calibration curve Result processing impossible analysis is not resident on the tray Serum interference Note During report printing from patients archive all flags are replaced by the generic symbol asterisk Section I Chapter G Displaying and Printing Results BT2000 PL Rev 0 Soft Ver 6 Page 7 of 7 OPERATOR MANUAL BT1000 amp BT2000 PLUS SECTION I GENERAL INFORMATIONS CHAPTER H 1 ANALYZER TECHNICAL FUNCTIONS 1 1 Service Functions 1 1 1 Analyzer Utilities 1 1 2 Mechanical Calibrations 1 2 Diagnostic Functions 2 ANALYZER SETUP Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter H Analyzer Technical Functions BT2000 PL Page Page Page Page Page Rev 0 Soft Ver 6 Index oO GN IN 1 ANALYZER TECHNICAL FUNCTIONS 1 1 SERVICE FUNCTIONS The analyzer has dedicated commands to allow Service and Diagnostic operatio
248. zer guides the user through the procedure This function is password protected The FCC procedure is useful for the correction of optical path of the cuvettes It Is performed only when one or more cuvettes are replaced or after a thorough service is performed on the instrument computer e g hard disk substitution where correction factors may be lost Temperature test Verifies thermostatic temperature of the reading cuvettes plate For a correct measurement it is important that the thermometer of low temperature absorbance miniature probe tip is used The measurement cuvette should be filled with 300 to 400ul of solution It is also important that the measurements are taken after the instrument has reached steady state approximately 20 minutes Empty Fluidics This command completely empties the fluidic circuit It is to be used exclusively as preliminary operation for maintenance or eventual moving of the instrument 1 1 2 MECHANICAL CALIBRATIONS This function allows mechanical centering and adjustments for the different positions of the sampling arm cuvettes plate sample plate and reagents tray Bear in mind that the analyzers are already factory calibrated and a new adjustment is seldom necessary To perform calibrations move the mouse cursor on the desired function and click to confirm Two buttons Dec and Ince are enabled on the screen Figure 2 and by pressing them the given object moves step by step either c

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