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BT3000 PLUS

1. for Yes or 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 gt Send CHECKSUM isis es cem van ues cce cd Mrd uou t 3 characters gt Send end transmission character 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 0 01 Check Sum Error 0 02 Unknown Command 0x03 es Routine STAT field Error 0 04 oerum Urine field Error 0x05 ee Clone Yes No field Error 0 06 Cup position Error OXOT copo xe Number of Analysis field Error Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 18 0 08 Wrong Number of Test X09 nee Position already in execution 0x0A
2. Cloning impossible 0 0 Code duplicated 0 0 One or more analysis not present in the analyzer 0xOD ee One or 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 with 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 uU Identifies the type of patient in this case Serum Identifies that the patient is not a clone DULL IE LM Unknown position the analyzer will insert the patient in a convenient position US sodes ries 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 case of reception problems Reception of the first available report in case one desires to receive again all the reports
3. Enable Reagent Refrigerator 50 zi Number of Routine 1 50 m Number of STAT 51 52 n i Number of Standards 1 20 6 2 Number of Controls 21 26 Figure 14 refrigerator for the reagents Click to select the desired temperature among the available Figure 13 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 14 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 Select level to modify Level 2 C Level 3 C Level 4 Printer Header Footer Bar Code Serial L S E Module Working Tempe
4. REAGENT COMPUTER Modules Arrangement Figure 4 Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 11 of 11 OPERATOR MANUAL BT3000 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 Index BT3000 PLUS Page Page Page Page Page Page Rev 0 Soft Ver 8 manch oodoomtmw 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 a protected place Store the empty wooden crate in a safe place for future use 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 Arrow Pointing Upwards Base Spring Clip Figure 1 Section I Chapter B Unpacking amp Installation BT3000 PLUS
5. 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 and 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 Section I Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver S Page 15 of 32 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 ients Tests ers St Pri r Utility External Program e0000 lob Patients Pro rams m Ir 4 1 est Paramet andards And Controls G 5 ntControls Print Standards 5
6. Value 23 0 Dut of limit Section Chapter F Population Patient s Archive BT3000 PLUS 0 Soft Ver 8 Page 5 of 23 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 25 A result exceeds Mean by 25 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 15 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 25 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 15 in the same direction and at least one result exceeds mean by 25 alternatively two groups of 4 consecutive results exceed the mean by more than 1S in the same direction and at least one result exceeds mean by 2
7. Functions Exit External Programs No Message 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 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 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 test s 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 an ISE if enabled refer to Chapter L 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
8. Section I Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 16 of 32 1 3 2 Relation tests Print parameters Print Controls Print Standards 002 003 123 Insert new tes Code Test type 040 Relation Save E c Lal wl Functions e e e e eal New Code Clear Code Rename Parameters Standards Controls Fig 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 v will be displayed then select Parameters Parameters for Relation tests Code 1 st Unit 2nd Unit Supplementary Factor 1 00 Normal range Min 0 000 0 000 TES Automatic Decimal Custom 0 000 0 000 Woman 0000 0 000 Child Fig 9 In the parameters window fig 9 enter the following information Name complete test name 4 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
9. Show Optical Transmission Show Diagnostic and General Diagnostic Patients Tests Analyzer Utility External Programs Analvzer s utilities Mechanical Calibrations Diagnostic Show FEC Show Optical Trasmission Show Diagnostic Analyzers utilities General Diagnostic Figure 3 F C C Result 11 2 2002 E FCC 451 0 427 451 0 489 449 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 1 153 452 0 280 457 0 930 450 0 753 463 2 165 459 1 314 456 0 656 s n Print Re Read values Exit a Figure 4 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 Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 11 100 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 0 100 0 100 0 100 0 100 0 100 0 100 0 Qen 100 0 100 0 Exit 100 0 E Figure 5 Show Diagnostic RET Tubes and Peristaltic 01 03 03 Kit Tubes and Peristaltic pump Kit Tub
10. HOST COMPUTER General The analyzer BT 3000 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 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 p Sena pauent Code istis oer bets Debit qub Qa bieten eins 15 characters gt Send list type for patient insertion T for Routine or R for STAT gt Send type OF Serum oerte obe ei en node e Duces S for Serum or U for Urine gt Send if the patient is a
11. 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 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 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 Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver amp Page 3 of 8 1 2 RESULTS PER TEST Fg 223000 X Pazienti OG Inserisci Routine STAT H9 CTRL6724 H3 0009457 GLI Glicemia
12. The unit has suffered severe shock such as being dropped Do not use the unit Consult your nearest sales service office regarding repair Stop using the unit immediately and disconnect the power supply Consult your dealer regarding repair Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 19 ANALYZER Blue Tube Black Tube Vacuum Pump Svstem Power Cord y a 2 o g Aspiration Pump Internal 7 Waste Probe Waste Chamber Pu d External Waste Container Fluidic Pathway Figure 2 Drain Tube ee ee ed eee kee ee eee eee nn LE Ne RT Electric Cable Level Sensor een ey APT AT gig zl m Red LED Waste Probe P N 07 05165 01 FIGURE 3 1 7 SPARE PARTS FOR MAINTENANCE The following is listing of spare parts which are available for field replacement PART NO DESCRIPTION VACUUM PUMP SYSTEM COMPLETE FOR BT3000 PLUS 07 05165 01 WASTE PROBE 330 6338 FUSE 250 VOLT 0 5 AT 330 6400 MAIN POWER SUPPLY CORDSET Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 19 2 VACUUM PUMP SYSTEM P N 662 0788 and BYPRODUCTS OBSOLETE NO LONGER IN PRODUCTION 2 1 INTRODUCTION This compact and silent waste suction unit has been specifically designed for use with the BT3000 PLUS chemistry analyzer where continuous elimination of l
13. _ 1 ANNUAL MAINTENANCE 11 05220 01 3 CUBITAINER 10 LITERS WITHBOX P N6624010 1 BIMONTHLY MAINTENANCE KIT 6624016 1 WASHING PISTON GRIP SLEEVE TOOL 662 1025 1 000 TRANSP SAMPLE CAPSULE 2m STD amp CTRL 667 1040 __ 50 REAGENTCONTAINER80 mi WITH 6671072 50 REAGENTCONTAINER50 mi WITH CAP 6671073 25 REAGENTCONTAINER20mI WITH CAP 6671074 REAGENT CONTAINER 10 ml WITH CAP 667 1076 ad 50 ml BOTTLE WITH SCREW CAP 667 1080 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 nearest 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 Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 10 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 instrument s weight 95 Kg and is large enough for it
14. 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 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 M Warnings and Precautions BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 6 1 3 WASTE DISPOSAL e Toensure 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 consumables from the instrument test tubes cups bottles containers fluidic tubing etc and thoroughly clean the instrument with an approved disinfectant for decontamination 2 Conta
15. 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 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 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 linearity 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
16. m C m oc n mi m oc Figure 16 Trender Graph Data Sequence 3 Histogram NUM Stat Histogram Print Preview co e Eo e x Correlation Coefficient Deviance Variance 22 75 Standard Deviation Variation Coefficient Num of Rec si 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 double clicking the mouse on a given plotted point position and value is shown Fig 16 its coordinates information about 5 Page 13 of 23 BT3000 PLUS 0 Soft Ver 8 Q C Population Patient s Archive Chapter F Section I L Jennings Graph Diagrams for DOM Val H Data Sequence Histogram 0 013 6 308 ae Stat Histogram Num of Rec Standard Deviation Variance Correlation Coefficient 43 0 736 0 542 0 114 E Mean Variation Coefficient Deviance Median a 6 598 11 16 22 75 6 500 Print Preview Figure 18 By clicking on L Jennings button L Jennings graph is displayed for the selected data Fig 18 By double clicking the mouse on a given plotted point information about its coordinates position and value is shown Fig 16 Histogram Graph Diagrams for DOM Val Data Sequen
17. 52 4288 Vi 7 reading from a single electrode 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 for 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 number of points during reading time Normalization of reading data elimination of erroneous readings 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 x 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 T where CC Oorrelation 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 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 10 of 32 1 2 5 METHODS DESCRIPTION End Point Once the sample has been added to its reagent a reaction occurs first causing a variation in th
18. E Save amp Conca Figure 7 Low standard position and High standard position Write in these fields or select with up down arrow keys the positions for S E calibrators NOTE The low standard position must precede the high standard position Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 17 Timed re run It is possible to program automatic execution of calibration using this parameter The analyzer will issue a warning message when the programmed standardization ends If the reagents and standards are present then one can directly perform the calibration Insert the standardization time by enabling Time selection and program the corresponding field One can enter interval of hours or days in this field Last Standardization The time and date of last test calibration are shown here Electrode K cl co Slope After each calibration 5 F FUE TT the calculated values for the uum 7 slopes are updated in these fields Calculated slope values must be within the indicated ranges Ann En D F010 Slope Min By double 700 ann 780 740 clicking the textboxes slope each electrode Refer to test methodology for correct values The slope values are ranges are individually set for important for verifying a correct calibration and the electrodes status When a slope is out of range it will probably mean that the electrode must be replaced Standar
19. LIPA TRG p 21 crcl FEF MAG TSF Ca CRE FENP M G2 URCO aso BiC4 CHE FRUT IGA MAG3 URE aso1 CHE cup f GGT NONE UREA BD GW YT 16 PCR X AUR BIND cHOL couce Pxo Function 3 9 o New Code Clear Code Rename i i Standards Controls Figure 2 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 17 Test Parameters Standards And Controls Current Tray E Print parameters Print Controls Print Standards BIC MAG GLUC UREA CRE EBIT ur CAL TRG LDH AMY CHOL r Functions 7 New 2001 Clear Code Rename Standards Controls Figure 3 GENERAL PARAMETERS In this page it is possible to program the general parameters for the ISE IA _ Sample ul Sample volume expressed in ul default General Parameters Serum s Parameters Urine s Parameters value is 30 ul Serum dilution 1 Reagent dilution 1 dilution 1 Pu Sets dilution ratio between a m EE Factor sample and reagent default value is set at 14 Ranaut ooo Reagent dilution 1 Sets dilution ratio for IUE concentrated reagent default value is 10 Using this cm Te nef af cl parameter the analyze
20. POSITION XX interrupted It is possible to run missing tests using the rerun commands Chapter E paragraph 1 5 SPECIAL REAGENTS SCREEN MESSAGE CAUSES amp REMEDIES NO 5 BUFFER The error message NO ISE BUFFER is displayed when the analyzer detects through a built in liquid sensor the absence of ISE buffer solution needed for programmed tests Immediately after this message the ISE sampling is interrupted Insert new buffer It is possible to repeat interrupted tests using the Re run option Chapter E paragraph 1 5 NO I S E BASELINE The error message NO ISE BASELINE appears when the analyzer detects through a built in liquid sensor the absence of ISE reference solution Baseline required for running programmed tests Immediately after this message the reagent sampling is interrupted Insert fresh reference solution baseline It is possible to repeat interrupted test using the Re run option Chapter E paragraph 1 5 NO I S E WASHING The error message NO ISE WASHING SOLUTION SOLUTION is displayed when the analyzer detects through a built in liquid sensor the absence of ISE washing solution and instantly the ISE sampling is interrupted To restart washing insert new washing solution bottle NO SAMPLE DILUENT 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 ad
21. 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 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 31 of 32 1 7 CREATING THE CURRENT ANALYSES TRAY Available In Tray Reagents positions 001 Reagent 1 G Big 003 Xx fi Position C Little Print tests on analyzer Save 9 Cancel 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 ic
22. 03 03 03 Value 14 27 Uldi 54 49 Ulidl 66 74 Ullal 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 0002222 0007502 0007708 0001052 0001991 0009614 0005706 0009850 0007879 0008246 0002360 0008013 Code Select All Name Select All Group Male Male Male Male Male Male Male Male Male Male Male Male Fig 31 Test Type Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Method Trinder Jundrassik Jundrassik Color XXX Jundrassik Color Trinder Trinder Trinder Color Select the test and click on Print preview All results matching with search criteria are displayed the PRINT ALL from here it is possible to print patients results corresponding to the search criteria Print Selection C Complete Report with preview Complete Report Quick Print C Records Selected Quick Print 9 Cancel These three kinds of printings will produce reports as shown in Fig 32 Section I Chapter F Q C Population Patient s Archive BT3000 PLUS 0 Soft Ver 8 Page 21 of 23 Complete Report with preview this option will allow printing of all patients reports matching with the search criteria A printing preview will be displayed Complete Report Quick print this option will allow printin
23. 800 seconds approximately 540 seconds approximately 12 minutes approximately 5 ml approximately 2 ml approximately 7 ml approximately 250 ml approximately 170 ml approximately approx 170 ml 13 ml Cuvettes Washing Solution 2 ml approximately 0 5 ml ISE Washing Solution 0 5 ml Enzyme Solution BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 5 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 ISE reagents 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 BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 5 OPERATOR MANUAL BT3000 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 Pa
24. 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 If the Reception 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 Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 18 Both the programs use serial port wit
25. ER 9 30 PM Astarte tt C i P InstallShield Wizard Now click Finish Now the proper installation procedure begins Open and close the CD ROM drive to enable autorun automatic starting of the BT3000 PLUS Proceed with installation as for a new instrument Section IT Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 23 of 23 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 6 6 TECHNICAL ASSISTANCE Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 6 Technical Assistance Index BT3000 PLUS Rev 0 Soft Ver 8 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 an 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 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 Chapt
26. Figure 3 4 3 MODULES The BT3000 PLUS analyzer is constructed of a one piece stainless steel structure The injection molded body in Baydur amp is placed on the chassis to cover the instrument Fig 4 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 SE MODULE consists of the electrodes panel the diluter the reagents holder and the electronics e SAMPLING ARM two is composed of a two axes based mechanical system accommodating sampling needle head with built in electronics including correct position sensor Encoder Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 11 7 COMPUTER BOX 2 READING STATION 3 POWER SUPPLY 4 REAGENTS MODULE 5 SAMPLES TRAY MODULE 6 ISE MODULE 7 SAMPLING ARM gt S _ gt S gt
27. It 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 Samples in order to bring the reaction into linearity range The final result is automatically multiplied by the dilution factor and will be checked with flag Hyperactive Sample out of final ABS Limit Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver Page 23 of 32 ABS Delta mABS This parameter expressed in mABS is used in all the methods except Only Reading It represents the maximum Delta for the reaction d
28. The disposable cartridge is based on snap fit principle As the cartridge is put in place and locked the three rollers within the cartridge engage the unit s drive shaft b Quick connect couplings consist of two fitting halves coupling bodies female halves and inserts male halves Valved fittings have Delrin shutoff valves that automatically stop flow when coupling is disconnected Body and insert snap together for a secure seal To connect coupling simply plug insert into body fitting halves lock in place instantly with an audible click which assures a reliable and leak free connection To disconnect the fitting halves simply press the thumb latch lever on the coupling body and the coupling halves separate Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 19 2 16 TROUBLE SHOOTING GUIDE SYMPTOMS CORRECTIVE ACTIONS Audible Alarm of 1 second a External waste container full Empty the frequency with the LED on external waste container and press the waste probe lit RESTART button to reset Waste Bottle Full Remedy the causes of alarm and then enter the command Start Another Tray to carry on the operating procedure with the analyzer NOTE n the mean time vacuum pump continues to function without blocking the analyzer for about 4 minutes as the waste chamber inside vacuum pump system is being used It is important to press the RESTART button on the vacuum pump cabinet to c
29. VED Trinder 57 65 mg dl 33 00 62 50 PRY Trinder 54 49 1 01 31 00 62 50 VED Jundrassik 53 48 ma dl 49 00 115 5 Colesterolo XXX 11 57 mg dl 27 00 66 50 Glicemia ARRA 51 95 mg dl 28 00 56 00 BID XXX 55 80 mg dl 45 00 109 5 Riliriihina Trinrer AG 34 matal 49 00 106 5 Fig 33 Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 22 of 23 3 4 Other menu functions In the main page Patient Archives Fig 23 some menus are available as shown below File Utility Delete Sendta 5232 Help File Utility Exit Utility Delete Sendta 5232 Help Setlp Backup View External Archive View Internal Archive Format Floppy Delete Send to Delete Records selected Delete All Search Delete All Archive S hift F 10 5232 Help Send to 5232 Help Send Record s Selected Send All Search Section I 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 d
30. Volumetric factor Serum volume First reagent volume Second reagent volume Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver 8 Page amp of 32 I S E Module Functions COMPUTING THE SLOPE es mV BL mV BL tod C BSF C BSF where S Slope Electrodes BSF BaseLine Factor mV mV High Standard mV mV Low Standard BL Base Line High Standard BL Base Line Low Standard Ch High Standard Concentration Ci Low Standard Concentration COMPUTING THE RESULT mV BL mVs BLs Conc s BSF where S Slope i Electrode BSF Base Line Factor mV mV Electrode mVs mV Low Standard BL Base Line Electrode Bis Base Line Low Standard Cs Low Standard Concentration 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 Clinical Chemistry Z Log y F FZ PSE Of Op where Z Zeroing with water F4 First Filters Value F2 Second Filters Value Fz First Filters Zero Value Fzo Second Filters Zero Value Op Optical path Of F C C Section Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S 9 of 32 LS E Module V 32768
31. and the Extra Patients Routine on the right During the working phase the Re run is also shown Click 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 execution 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 12 together with the situation for Routines STAT Controls and Calibrato
32. even if no ISE determination has been performed b Run Prime 1 5 and repeat it three times refer to Chapter H paragraph 1 1 1 c At the end of this operation release tube 5 Figure 11 from the peristaltic pump and remove the tubes from the pinch valve to avoid sticking and collapsing of tubes NOTE In case the ISE module has the and CO electrodes then also disconnect the tube 2 connected to electrode see Figure 11 After a long period of system s inactivity perform the following a Connect tube 5 to the peristaltic pump insert tubing into the pinch valve and connect the tube 2 to K electrode b Run Prime I S E and repeat this procedure for three times refer to Chapter H paragraph 1 1 1 CAUTION Refer to the Troubleshooting guide in case of problems during system restoring Turning off BT3000 PLUS system equipped with ISE Module During turning off procedure the analyzer requests whether the cuvettes and the ISE Module should be washed with Cleaning Solution and Enzymatic Solution In case of an affirmative response the analyzer will wash both cuvettes and electrodes otherwise it is possible to wash the cuvettes only and not the ISE module or vice versa by clicking the appropriate icon in the Analyzer Utilities menu NOTE It is important to wash electrodes everyday even if the ISE Module has not been used This makes the electrodes more stable prolongs their life 1 10 TROUBLESH
33. lt Length gt String length 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 match 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 Section IT Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 8 of 18 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 gt Begin repetitive group Set End lt Name of group gt 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 comm
34. rogram the positions and enter the calibrator concentrations entire corresponding to the first desired position Select 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 Ea Dilution with solution Normalization procedure for the stored calibration curve Print parameters Re calibrating on single point i Calibration point fi Sample position Reagent m4BS Timed re run 00 00 00 Time selection C Automatic dilution Last Standardization lt Not Performed gt Number 1 2 3 4 0 000 0 000 0 000 0 000 5 0 000 0 000 0 000 0 000 100 sz from last calibration itions Graph Print Automatic adjust Save Cancel D see Figu
35. slow intermittent beeps and the waste probe LED is lit External waste container full Empty or replace it and press RESTART button Green to continue the operating procedure and to reset the alarm second alarm on rapid intermittent beeps with the LED on the waste probe lit The external waste container and the internal waste chamber are full The vacuum system stops itself the analyzer interrupts working phases and displays the message Low pressure Empty or replace the waste container and press the green RESTART button on the vacuum pump cabinet to continue the operating procedure and to reset the alarm If the audible alarm is still activated it means vacuum pump for draining is not efficient or the defective 3 way solenoid valve and that the internal waste chamber is still full The vacuum system stops itself the analyzer interrupts working phases and displays the message Low pressure Consult your nearest sales service office regarding repair 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 WARNING external water container to continue the tests Check replace if NO WATER necessary the tubular filter on the intake tube inside the water tank item b paragraph 1 3 The analyzer will start working from
36. used for entering the volume in ul of water that must be used for washing the hydraulic circuit at the end of a test determination Note The electrode is automatically 0 000 0 000 Woman Print poo Chid excluded In Urine s parameters it does not Ak fnis B appear even if it is present in the electrodes in use Figure 6 1 3 PROGRAMMING STANDARDS AND CONTROLS INSERTING STANDARDS Go to Test Parameters Standards And Controls Global page Figure 2 or the Test Parameters Standards And Controls Current Tray page Figure 3 Select ISE and then click Standards to display the Standard parameters for ISE Figure 7 Standards programming automatic or on request follows the same procedure of Clinical Chemistry Chapter C Standard parameters for ISE fis 2d Low standard position 20 zi High standard position Timed re run 0000 00 f Last Standardization 11211202 20 01 56 Electrode paragraph 1 5 Calibrations For system calibration two known standards Low and High are required The calibration parameters of the module and the relevant slopes calculated for each electrode are displayed together Here it is possible to set an automatic standardization timer and assign two positions for low and high standards same as clinical chemistry procedure outlined in Chapter C paragraph 1 5
37. 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 e Results 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 r
38. 03 2003 8 09 29 Questa nota abbast 0001831 Verdi Paolo Mali 04 03 2003 8 09 31 Questa nota abbast 0001431 Rossi Roberto Mal 04 03 2003 8 09 33 Questa nota abbast 0006312 Doh Francesco Mal 04 03 2003 8 08 33 Questa amp una nota abbast e Search Test Report Print All o Exit _ Version 1 0 41 1415 Figure 23 To run a query it is possible to specify various parameters Fig 23 such as Tests date range Analysis code range Name ourname 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 Into Record Quick Print Select date View Analyses can be activated also by double clicking 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 query result Quick print prints immediately the patient s report Select date Clicking on the icon next to the editing window March 203 2 Q si Sun Mon Tue Wed Thu Fri Sat 1 Choose Date for selection of tests date it is possible to select the desired date range for searc
39. 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 M Warnings and Precautions Index BT3000 PLUS 0 Soft Ver 8 1 WARNINGS AND PRECAUTIONS 1 1 POTENTIAL RISKS DURING OPERATION AND MAINTENANCE USE Although the BT3000 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 extreme 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 cau
40. 1ml every liter of water ratio 1 1000 must be connected to the upper connector identified by a white flange Its other end goes to the external water container The black tube for cuvettes waste fluid must be connected to the middle connector identified by a black flange Its other end goes directly into the second input connector of the vacuum pump The blue tube must be connected to the lowest connector with blue flange on the fluidic manifold Its other end goes directly into the first input connector of the vacuum pump system Refer to Figure 8 Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 10 WARNING 1 Do not use the vacuum pump System with any other fluid source except the BT3000 PLUS analyzer The unauthorized use may result in serious injury to the user and permanent damage to the vacuum pump system Vacuum Pump System Always check and empty Analyzer the full waste container Analyzer Blue Tube and press Restart button Black Tube Restart C To Analyzer Waste Probe C Normal Pressure AN WARNING 1 Read vacuum pump system instruction and warning notices carefully 2 Disposable gloves must be worn when servicing the vacuum pump system where hands may contact potentially contaminated waste materials C Low Pressure C Low Pressure Alarm Figure 8 Vacuum Pump System P N 06 05161 01 03 for BT3000 PLU
41. 9625 SINTERED BRONZE SILENCER FIG 2A VACUUM PUMP SYSTEM TARGA PLUS COMPLETE SYSTEM WITH 2 WASTE PROBES 230 VAC WASTE PROBE 1 FIG 3A WASTE PROBE 2 FIG 3A 662 0788E VACUUM PUMP SYSTEM PLUS COMPLETE SYSTEM WITH 2 WASTE PROBES 110 VAC 662 0807 HYDROPHOBIC FILTER ASSY PUMP FIG 2A IMPORTANT NOTICE a There are no user replaceable parts within the pump system For any repairs to the vacuum pump system contact your local Sales Service representative office b Continue pressing the RESTART button until the waste chamber inside the cabinet is emptied approximately 30 seconds and the pump will beep continuously This operation must always be performed prior to any internal repairs or shipping for service Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 19 TRANSPARENT TUBE TUBO TRASPARENTE T ou ANALYZER ANALLIZATORE NC Fa y BOTTIGLIA HO J H O BOTTLE TUBO NERO BLACK TUBE TUBO BLU BLUE TUBE CAVO DI ALIMENTAZION PWR SUP CABLE VACUOMETRO rs aw il VACUUM GAUGE aN uL go AO ity PAX 2 LH m RIMUOVERE LE VITI uM B DI BLOCCAGGIO PER IL TUBO BLU NA SONDA Di SCARICO 1 TRASPORTO LATO INFERIORE BLUE TUBE WASTE PROBE 1 REMOVE TRANSIT SCREWS AT PERISTALTIC THE BOTTOM X TUBO NERO SONDA DI SCARICO 2 BLACK TUB
42. A decimal value 65 or hexadecimal value 41 then we can write A 65 or 0x41 String Identifies a sequence of printable characters enclosed in single apostrophes for example this is a string Comment Identifies a portion of test preceded by a character which will not be compiled but will serve as note only for the programmer Variables 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 Section IT Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 18 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 lt String gt lt Length gt Where String Transmit receive string
43. End Date 14 12 2001 Exit Alt F4 Far Analyses For Method Export Data For Lok Import Data Total Figure 9 Figure 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 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 M Quality Controls Functions Preference Archive an Floppy Printer Setup Functions Figure 11 Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 8 of 23 2 POPULATION Q File Tool Deleting Help Version 1458 2121 Figure 12 The Population module manages and displays graphs as well as data and computes statistics on data of all the analyses performed by the instrument This software module i
44. Erorsi B Bubbles in ISE Module D JU L R EN O X C Section Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver amp Page 7 of 8 In the patients archive active flags will be highlighted in red and will have the check in the corresponding box Flags quick reference with patients archive ao zd el lO 7 IS IR IT Id I gt lt IC Figure 5 SectionI Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver 8 Page 8 of 8 OPERATOR MANUAL BT3000 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 Setup Index BT3000 PLUS Page Page Page Page Page Rev 0 Soft Ver 8 l QT 1 ANALYZER TECHNICAL FUNCTIONS 1 1 Service Functions The analyzer has dedicated commands to allow Service and Diagnostic operations 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 1 1 1 Analyzer Utilities Analyzer s utilities f Wash cuvettes X Wash and fill up Extra wash
45. Every E E 0 000 Low Value 000 Low Value 0 000 Theoretical Value 0 000 Theoretical Value Sete 9 PH 0 000 High Value 0 000 High Value Timed Timed Timedrexun 01 08 30 Timed re run Timedrexun 00 08 30 Level 1 Level 2 Level 3 Level 3 Level 1 Levell2 Level 3 L Functions Functions ET Print view used positions c 9 Exit New Code New Code Figure 9 Figure 10 Known Enter lot name or number mean value and min amp max limits Enter tray s position already set to controls in the section Setup Analyzer included in the inner ring of samples tray Unknown Enter lot name or number and tray s positions Reserved positions are those already set in the program Setup Analyzer which are shared with known ones RUNNING STANDARDS AND CONTROLS The functions Run Standards and Controls can be accessed from Tests main menu or through the specific icons that allow direct access Fig 11 and 12 The displayed analysis 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 Run Standards Direct access icon Run Controls Direct access icon Select Standards Controls Select Standards Controls cre ISE1 TRG ISE
46. H51 0002151 9 CTRL6724 3 0009457 Inserisci Batch V GLU Glucosio Esecuzione pazienti in attesa 5 CTRL5496 H9 CTRL6724 3 0009457 7 CTRL4251 Ripetizione per analisi V LIP Lipasi Cancella lista pazienti 51 0002151 3 0009457 PRY H51 0002151 9 CTRL6724 H3 0009457 H CTRL4251 RAT H51 0002151 9 CTRL6724 3 0009457 VED 51 0002151 9 CTRL6724 3 0009457 ____ 52 4 87 1 46 4 64 5 5 x ng dl ug L 5 03 6 93 43 0 102 35 0 96 5 ng L ng L ng dl 7 01 8 86 5 75 11 0 55 5 27 0 82 5 20 0 46 0 ng dl 5 35 mg dl 4 21 14 0 54 0 mg dl 0 670 19 0 65 5 UI dl 4 94 mg dl UI l 9 95 3 37 26 0 68 0 33 0 91 5 UI dl 9 41 10 0 71 0 ng L 3 93 55 0 103 mg L 3 56 38 0 97 0 mg L 6 05 UI l 4 87 46 0 119 UI L 2 11 43 0 98 5 ng dl 6 33 44 0 80 0 mg L 6 00 26 0 72 0 ng dl 8 96 25 0 84 5 mg dl 4 96 37 0 65 5 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
47. 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 counting 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 19 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
48. PRECAUTIONS THE WARNINGS INFORMATION THEREFORE IS NORMALLY USED TO CALL ATTENTION ONLY TO THE MOST IMPORTANT PRECAUTIONS OR TO THOSE THAT ARE NOT NECESSARILY LISTED WITH THE INSTRUMENT COMPONENTS THE RESPONSIBILITY FOR THE SAFE USE OF THE INSTRUMENT OF BIOTECNICA INSTRUMENTS S p A RESTS WITH THE CUSTOMER THE INSTRUMENT SHOULD BE OPERATED OR SERVICED BY THE QUALIFIED PERSONNEL FAMILIAR WITH LABORATORY PROCEDURES AND WHO ARE ALSO FAMILIAR WITH THE NATURE OF THE SUBSTANCES USED IN COMBINATION WITH THE INSTRUMENT AND ANY NECESSARY PRECAUTIONS WHICH SHOULD BE TAKEN IN THE HANDLING USE AND STORAGE OF THE PRODUCTS IN NORMAL USE THE CUSTOMER SHALL BE RESPONSIBLE FOR THE CONTROL AND USE OF THIS INSTRUMENT WHETHER ALONE OR IN COMBINATION WITH OTHER ARTICLES OR SUBSTANCES OR IN ANY OTHER MANNER WHATSOEVER Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 19 2 8 Technical Specifications Mains Voltage AC DC Power Supply for Electronics Input Voltage Range Input Frequency Output Voltage Range Operating Temperature Vacuum Pump Pump Type Rated Voltage Operating Vacuum x 109 Attainable Vacuum Max Peristaltic Pump Drive Motor Speed Flow Rate Tube Material and Bore Transmission Media Life Expectancy Hi Lo Level Sensor Filter Life expectancy Dimensions Approx Height Width Depth Weight EMC Electrical Standards Warranty TECHNICAL SPECI
49. Rev 0 Soft Ver 8 Page 2 of 10 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 v Contents of the large wooden crate ANALYZER OK 1 USER S MANUAL 1 INSTALLATION DISK oo o 2 DISKS FOR TOUCH SCREEN 0 1 WINDOWS SOFTWARE DISK SS 1 KEYBOARD DRIVER gt S 1 UPSDRIVER 0 o 1 PRINTERDRIVER NN DISKS OF PARAMETERS v Contents of the small wooden crate accessories and peripherals CORDLESS KEYBOARD amp MOUSE P N 662 2057 1 UPS UNIT 1100VA P N 330 2132 1 POWER CORDSET P N 330 6391 2 POWER CORD FOR PERIPHERAL DEVICES 330 6400 INTERFACE CABLE FOR PRINTER P N 330 2165 PRINTER P N 330 2172 VACUUM PUMP SYSTEM P N 06 05161 01 1 WASTE SUCTION PUMP 1 WASTE PROBE 1 BLACK TUBE WASTE 1 BLUE TUBE WASTE 1 TRANSPARENT TUBE FOR DISTILLED WATER 1 TRANSPARENT OVERFLOW TUBE 2 2 FUSES 250 VOLT 8AT P N 330 6342B QUARTZ HALOGEN LAMP 12V 35W 9 P N 330 9321 CLEANING TOOL FOR SAMPLING NEEDLE 662 0629A 1 1 1 1 1 1 1 1 1 1 Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 10 Qty Descipion OK 1 SP MONTHLY MAINTENANCE KIT 11 05219 01
50. 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 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter A System Description Index BT3000 PLUS Rev 0 Soft Ver 8 SOoOORWN 1 INTRODUCTION The BT3000 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 BT3000 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 FUNCTI
51. 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 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 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 ZCheckSum 3 Check Sum transferred as a string of fixed length equal to 3 characters Section IT Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 18 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 wh
52. 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 that 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 II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 18 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 exa
53. Volumes calibration Dilutor prime T calculation 5 E module prime Extra V ash Il 5 E Module E F Empty Fluidics 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 filling up cycle with distilled water of the hydraulic circuit and sampling system 1 5 module prime Fills up the fluidic circuit of the ISE module Extra Wash I S E Module It is used for a complete extra wash with appropriate solutions ISE Cleaning Solution and Enzymatic Solution of the fluidic circuit of the ISE module 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
54. 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 fi mo rg 01 fig o oc wr 12 Wu es E LM wp EM EM ew Select 49 50 Deselect LEM EN LUN DU LO LN ES LM Figure 15 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 Figure 15 Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 19 Work Lists Routine STAT Control Standard New Entry outine Current Tra outine EJ AUTOBATCHO03 AUTOBATCHOD4 7 im m m n Fa Fa Fa im im n n n TY 4 E E 13 15 17 19 21 23 25 27 23 31 33 35 37 39 A Figure 16 Work Lists Figure 16 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 Pa
55. 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 Setup BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 11 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 If the instrument is equipped with an ISE module then place an empty reagent container 10 ml in the position of Wash Solution ISE module 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 analyzer 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
56. another concentration the different potentials will be observed with the same slope values To optimize system performance it is fundamental that both the slope and potential values are always around established levels In case the slope values are out of range an on screen error message is displayed even if there is an incorrect response from only one electrode A check is also performed on the slopes reproducibility The values obtained during current calibration are compared to the values of previous calibration An error message appears during calibration if there is a variation greater than 3 for and Na and 5 for CI and CO Each standard measurement is followed by a baseline measurement The baseline is a reference solution used for compensating any eventual drift of the system Section 1 Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S 10 of 17 IMPORTANT NOTICE a After an incorrect calibration or in case of a calibration beyond the preset limits the analyzer automatically performs a new calibration with up to 3 calibrations maximum b Once the calibration standards are poured into the sampling cups they are stable for no longer than 15 minutes If calibrations for any reason last longer than this time it is necessary to replace standards with fresh ones and repeat the calibration The bottles containing buffer and reference solutions must be placed on the analyzer open bottles at room temperature at least 30
57. command saves data and then closes the window Non Linear analyses These tests require from 3 to 6 standards Enter the number of standards to be used in the Number of Samples field Enter the actual positions on the tray for each standard and then the related concentrations Conc The values are automatically updated during calibration into the ABS boxes Standard parameters for IGA To use standards pre dilution Re calbration on single point Deben function enable the Automatic Dilution It is then possible to 2 3 Ditton select whether dilution must be performed with water or physiological solution Dilution with solution In the Dilution field enter the required dilution ratio If automatic dilution is not required then appropriate concentration of the corresponding standard must be entered in the each concentration field Dilution with solution Graph This command displays the graph of the stored interpolation curve In the graphic display page data and curve are displayed together and can be printed Print parameters Fie calibrating on single point Timed re run 0 00 00 Time selection m Calibration paint Sample position 100 x from last calibration e View used positions e Graph Print Log Logit 4 Automatic adjust amp Save 9 Cancel Fig 8 Functions New Code Normalizati
58. 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 Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 19 DISPLAYING REAL TIME DATA 51 0003216 41 7 HI GL 2 90 47 0 83 5 E 51 0003216 BID amp Lolor 25 1 ug L i 1 41 44 0 62 0 51 0003216 Lipasi 656 3 mg dl 4 11 58 0 97 0 51 0003216 FAC T4338 ug L i 7 88 43 0 85 5 51 0003216 PRY 6 UI l 7 58 29 0 72 5 51 0003216 Glicenia 59 1 ug L i 3 70 41 0 83 5 51 0003216 Bilirubina Jundrassik adat UI l Bass 59 0 1AF a 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 ANC 99 6 ng L 5 22 48 0 108 6 CTRL2011 BID ANC 27 3 UI l 1 05 36 0 106 H6 CTRL2011 Figure 21 The Figure 21 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 informatio
59. 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 Section I Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 17 of 32 Fig 10 a Fig 10 b A window divided in two parts will be displayed one for the calculator and one for the analyses list current tray Fig 10 a 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 function 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 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 ur
60. 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 Results are invalid or cannot Sampling imprecision due to dirt in the dilutor be reproduced due to residues 1 Disconnect dilutor tubes _ in the dilutor 2 Remove the two mounting screws on the transparent dilutor chamber and clean the piston with soft lintless cloth dampened with alcohol Rinse the chamber and reassemble Connect the tubes to appropriate ports Results are invalid or cannot be Sampling imprecision due to the presence of air in the reproduced due to air in the hydraulic circuit Probably caused by the clogged tubular filter sampling system in the external water container Check replace Filter if necessary Figure 6 Sampling imprecision due to deteriorated tube in the dilutor pinch valve nspect and replace Tube Figure 2 No 1 Sampling imprecision due to reagent or sample residues in the sampling tube or in the needle Inspect and replace Peristaltic Pump Cartridge Figure 2 No 4 Check and replace the Sampling Needle Figure 7 Check and replace the Sampling Tube Figure 7 To be replaced by qualified service technician only Sampling imprecision du
61. icon ES E L5 fed L3 iH 13 15 17 19 21 23 25 27 29 31 33 35 37 33 n n RR EA d wd d d d d di di di di di di d dj dj dj dj i n B Figure 13 allows tests re run repetitions on user s demand Routine Default displays 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 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 Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 19 Example of entering samples New Entry Routine Code gt Group iy Type Assigned Group f Man Serum Routine C Woman Urine CTRL Routine Surname C Child E Name Draw Date External dilution factor 06 03 02 fi 00 Position Ar I CM Test B Profile E Delete 3 Save B Run Exit Available profiles Analyses C3 Select gai p a E caa els Deselected E Max selec
62. 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 12secs Graph for patient STDOO1 Test 420 E Skip ta Code Figure 4 Section Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver amp Page 6 of 8 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 A TIU gt S No Error result to be accepted X C Note During report printing from patients archive all flags are replaced by the generic symbol asterisk J L I gt gt lt lt lt S P
63. j 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 L1 Order number Date Description of the problem Request for Repair LJ Exchange LJ Quotation LJ Urgent Name oignature Biotecnica Instruments response Return authorization number 2004 Date Approved Yes 0 No LU Repair Exchange U 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 EXCTRACT 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 Biotecn
64. mg dl i 2 3A Colesterola 6 79 UI l i 25 13 p 52 0003894 Claro David STAT Glucosio lt Color gt 26 1 UL dl i S S1 U 115 Lipasi lt Trinder gt 41 5 mg dl i 4 65 33 0 61 5 PRV lt Color gt 92 4 mg dl i 5 02 49 0 115 VED lt Trinder gt 92 9 mg dl i 7 04 54 0 98 0 FAC lt Color gt 4 67 mg L i 4 57 20 0 76 0 H51 000653 Rossi Matteo STAT BID lt Jundrassik gt 41 0 mg dl i O 900 42 0 99 0 t gt H3 0008117 Barnard Fabio Routine Glicemia XXX 55 5 HI dl i 2 05 32 0 59 0 BID lt Jundrassik gt 96 1 HI dl i 1 06 51 0 108 Lipasi XXX 15 5 ng L i 8 00 42 0 122 PRY lt Trinder gt 30 6 mg dl i 2 41 13 0 47 5 Figure 19 The Patient s data display page is shown in Figure 19 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 S 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 ZXX 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
65. months 3 months Cl amp CO 3 months UTILITY EXECUTION TIMES Wash amp Fill Up 2 0 seconds approximately Wash H20 180 seconds approximately Zeroing 420 seconds approximately F C C 900 seconds approximately Extra Wash I S E 800 seconds approximately Extra Wash Cuvette 540 seconds approximately Wash Shut Down 12 minutes approximately WASH VOLUMES Clinical Chemistry Washes H O Single Wash of Cuvette o ml approximately H O Single Wash of Needle 2 ml approximately Consumption per test 7 ml approximately H20 for Zeroing 250 ml approximately H20 Total Wash of Cuvette 170 ml approximately Extra Wash of Cuvettes approx 70 ml H2O 13 ml Cuvettes Washing Solution 5 Washes H20 per test 2 ml approximately S E Extra Wash 0 5 ml I S E Washing Solution 0 5 ml Enzyme Solution Section I Chapter O Technical Specifications BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 6 DATA MANAGEMENT Computer gt Pentium IV gt 2400 MHz or more IBM compatible DVD CD Rom Player gt 16X Hard disk 220 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 NOTE 1 As regards the technical specifications for the system instrumentation reagent used in the appli
66. 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 N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 16 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 ACTIONS The instrument or one of its Verify that the UPS group is turned on the electrical cables peripheral devices does not are correctly connected and check the fuses If fuses need replacement then observe the following procedure Turn off the instrument by pressing the main switch on the rear panel and unplug power cord Extract the fuse
67. now and set the date amp time later mm 115 1 130117 Setup E TOEI T sot date After making appropriate corrections click NEXT key The Setup requests to enter Name of instrument and Organization rofessional AME ws 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 Enter bt 3000 plus as and biotecnica instruments S p A as Organizzazione Click NEXT key Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 23 Now type the each STILE P JD 1 5 Product Key of Windows the Product Key is composed of 5 groups of 5 characters 2000 Professional Setup identifi a aig riti 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 Windo the Administrator Password for your system ws 2000 Professiona ELEME Yos dd Run Adi ministra stor P a andan 1211 Q1 4 In the field Administrator Password type ENZO and rewrite it in the field Confirm Password Sec
68. 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 BT3000 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 the 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
69. on line F1 FUNCTION ICONS BAR 1 To Insert New Codes Parameters Standards and Controls for all Analyses 7 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 a Results Listed per Patient b Results per test in real time CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 19 7 12 No Results 13 Reaction Graphs 14 Turning ofF the System Simply positioning the cursor on the icons the so called 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 Ctri 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 wi
70. 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 Successiva Precedente Section Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page4 of 32 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 n
71. 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 yx Tests Analyzer Utility External Programs 6606000960 dInsert Mo dify Batch entry 02 rg 03 o 10 12 EE I IND ID Select 8 8 C 4 50 Deselect Figure 11 Section 1 Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 11 of 19 1 5 WORK LISTS op ns AUTOBATCHOO4 E E 3 13 15 17 13 23 25 i27 24 33 35 37 39 Figure 12 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
72. performed on a single title When an out of limit variation occurs a message informs the user and the calibration will not e View used positions Linear Print Dai x i Ear be stored the previous positive calibration will remain in J Enable Auto Adjust Save 9 memory Figure 7 Reagent mABS It is a read only field and it is updated every time the blank reagent is performed In case Dynamic Blank is enabled refer to Chapter C paragraph 1 3 3 Primary Analytical Parameters then the reagent ABS value and the variation detected during blank s reading are displayed Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 19 from last calibration It is a percentage check made between current and previous calibration It compares the newly determined ABS 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 Automatic adjust It is a password protected parameter that enables or disables automatic modification of test results in case of an additional calibration run during patients execution Last Standardization This field displays date and time for the last stored positive calibration By double clicking over the date textbox it is possible to display the previous calibration parameters Save This
73. 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 Primary parameters Check Parameters Secondary parameters Code Lu Bar Code Test methodology Trinder Method End Point a Reagents gt Kind of process E Linear M 8 Sample C Times gt ial Copy From amp e Cancel 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 Primary parameters Check Parameters Secondary parameters Code Test methodology Trinder Method End Paint T Only Read End Paint 2 Points Latex LIE Edit dili Reagents E gt W Sample E C3 Times E gt Te Copy From Figure 13 Section Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS Available Methods Fig 13 End Point Kinetic Fixed Time Initial Rate I R sample Blank type A Sample Blank type B Only Read End Point 2 Points Sample Blank A b oample Blank B b End Point Starter Absolute End Point Rev 0 Soft Ver 8 Page 19 of 32 linear This function is used for linear reactions it requires analytical test calibration to process computing factor with
74. pump Connect the shorter feed tubing to the quick connect on the waste chamber Install the cover and tighten screws NOTE The hydraulic circuit inside the pump cabinet accommodates quick connect fittings The fittings provide excellent sealing reliability no flow restriction and prevent accidental disconnection The approved tubing for quick connects must always be cut clearly at 90 angle To connect disconnect observe the following simple steps a To connect simply push tubing into collet past the O ring to the internal tube stop Steel teeth on the collet grip tubing for leakproof connections b To disconnect press collet against fitting body to disengage steel teeth and slide out tubing Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 19 2 15 PERISTALTIC PUMP CARTRIDGE REPLACEMENT Peristaltic pump features removable cartridge pre loaded with special PHARMED tube eliminating set up errors To replace cartridge proceed as follows 1 Remove both ends of the peristaltic tubing with elbow inserts from the quick connect couplings Remove elbow inserts for reuse 2 Squeeze the locking catches and remove the defective cartridge and discard it 3 Introduce elbow inserts into the pump tubing Place the new cartridge on the drive shaft and gently press to snap fit 4 Carefully connect the pump tubing to both quick connects on the front panel The pump is now ready for operation NOTE a
75. readings It is suggested to insert the bottle containing buffer solution open bottle at room temperature in the reagent tray at least 30 minutes before operating phases begin and to allow for equilibrium with ambient temperature and with the carbon dioxide CO2 level in the atmosphere If the thermal equilibrium is not reached then the phenomenon of drift and erroneous results may occur while a lack of equilibrium with may provide higher result values for the latter test NOTE ISE Module should be calibrated only after the above mentioned equilibrium has been reached When using the chemical standards bear in mind that they are altered by air exposition Therefore it is recommended to fill the cups 74 full to minimize evaporation effect and run the calibration immediately afterwards and then discard the remaining standard In any case do not leave standards exposed to air for longer than 15 minutes It is suggested to run Prime I S E before running tests and repeat this procedure at least three times It is recommended to run the standardization twice a day in the morning and in the afternoon or in any case every four hours To ensure a successful calibration repeat it up to three times and verify if the results are stable Standards and samples should be at room temperature before they can be used Bear in mind that also the samples are altered if exposed to air for more than 30 minutes The buffer bottle must al
76. single test a Sample Position XX b Sample code c Sample Type d Results 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 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 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 Exit Exits from data display page Section Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver 8 Page 4 of 8 1 3 DISPLAYING REAL TIME DATA 51 0003216 51 0003216 BID lt Color gt 51 0003216 Lipasi 51 0003216 FAC 51 0003216 PRY 51 0003216 Glicemia H51 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 c 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
77. 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 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
78. 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 Fas xj Patients Tests Analyzer Utility External Programs 0282 08 O06 G6 00 028 O 23808 Insert Routine STAT Insert Batch Run all pending patients analyses Program Code 7 2 47372313122837231 7 beta Access level 100 MASTER 13 04 2005 10 32 28 RT 20 C CT 36 6 C 35 mBar e 9 0 Main menu each menu generates other commands and or options 2 amp 3 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 Messages bar clicking here opens a window showing the messages received by the program 7 Errors bar by clicking here a window is opened showing the errors occurred during the work session Vertical Bar Commands Direct access to function commands 9 Refrigerator Status Indicator Indicator for Operating Pressure Ambient Temperature RT Cuvette Temperature CT Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 17 SERVICE ICONS BAR Stand by Analyzer F6 Reset Analyzer F5 Displays the Volumes
79. 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 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 instrume
80. 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 Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 24 of 32 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 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
81. 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 fr Jus o Patients Tests Analyzer Utility External Programs s p P D e Insert n all pen patients epetition analyses Clear Patient List a Cen mBar Figure 1 Section I Chapter System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 11 2 BASIC OPERATING PRINCIPLES OF THE ANALYZER The BT3000 PLUS is an automatic analyzer based upon the spectrophotometry principles The light absorption laws rule the performance of spectrophotometers he amount of light radiation that passes through a homogeneous absorbing medium is defined as transmittance T where T 1I lo l 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
82. 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 and Related Functions BT3000 PLUS 0 Soft Ver amp 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 flashram memory of the barcode scanner module Ean13 code39 Codabar Inter
83. where it stopped see Chapter E paragraph 1 5 If the error message persists because of defective loading pump contact the approved technical assistance THERE ARE THE The message Extra wash is displayed during normal working sessions when the analyzer has been previously switched off without FOLLOWING following the proper shutdown procedure Chapter E paragraph 1 6 Execute a washing procedure Chapter H paragraph 1 1 to OBLIGATIONS IN prevent continuous appearance of this message This message does DIAGNOSTIC not stop test execution but it is not possible to guarantee correct EXTR A W A S H results if an effective Extra Wash is not performed Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 16 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
84. 0 Soft Ver S Page 20 of 32 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 Z2 see Fig 16 in accordance with number of reagents programmed Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters Code 2 E Number of reagents Iw Test methodology Volume pl 1150 Method L Concentrated End Point dil Reagents p Kind of process f Dilution with water C Water with solution 1st Filter 2nd Filter 340 700 Times E gt 100 Reaction direction Reagent 1 Reagent 2 ncreasing C Decreasing Copy From C None Figure 16 e 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
85. 02151 19 3 UI dl 9 41 10 0 71 0 9 CTRL67124 0 ln eee ug L 3 93 55 0 103 43 0009157 aaa mg L 3 56 38 0 97 0 7 CTRL4251 56 0 mg L 6 05 RAT 51 0002151 i ee ee UI l 4 87 46 0 119 9 CTRL6T24 0 ln eee Uzi 2 11 43 0 98 5 3 0009457 89 3 mg dl 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 4 Stampa Figure 20 After the termination of programmed task the results can be viewed per Test The test Results display page is shown in Figure 20 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
86. 1 1 In case the error message still persists contact approved technical assistance The message LAMP EXHAUSTED 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 new Photometric Zeroing refer to Chapter 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 paragraph 1 1 1 If after observing these steps the mess
87. 2 LAVA 15 MAG FEF A GLUC BIT LIPA AAA CAL Known Unknown L1 1 1 TRG 2 2 ccc PE ae cob bi Select All Deselect All Run Select All Deselect All Run ea Immediate Standards e Timed Standards e Immediate Controls e Timed Controls x00 Ee Os Or Figure 11 Figure 12 Section IT CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 19 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 Gee E E E E Re run Routine STAT Control Standard New Entry Extra Patients Routine 1 ions Direct access
88. 2 and by pressing them the given object moves step by step either clockwise 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 Setup BT3000 PLUS Rev 0 Soft Ver 8 Page3of 1l T Clinical Chemistry Arm n e Washing position ex Washing position ISE rs gi Arm on 1st ring gi Arm on 1st ring ISE Sample tray Di rect Access Icon IE Arm on 2nd ring IE Arm on 2nd ring 15 Arm on 3rd ring Arm on 3rd ring ISE Reagent tray B4 m on ath ino PAamonahing tse ca 1st reagent Arm on diluent ISE Cuvette tray ca 2nd reagent Nf on funnel ISE Lik Cuvettes position 0 Arm on enzyme solution ISE Arm on washing solution 15 Arm on buffer solution ISE Arm on reference solution ISE lk Cuvettes position ISE ti Test Figure 2 The Calibrations menu is subdivided into three columns Clinical Chemistry Arm ISE Arm and Tray as shown in Figure 2 The following commands are available CLINICAL CHEMISTRY ARM Washing position Arm remains on the washing position upon which it must be centered Arm 1 ring The samplin
89. 222 Verdi David Mal 27 02 2003 18 54 48 Questa una nota abbast 0007708 Verdi Paolo Mal 27 02 2003 9 54 48 Questa amp nota abbast 0001052 Verdi Robert Mal 28 02 2003 8 52 18 Questa nota abbast 0001991 Doh Mari Mal 28 02 2003 10 55 57 Questa nota abbast 0009614 Barnar d Matte Mal 28 02 2003 10 55 58 Questa nota abbast 0005706 Mati Nicola Mal 28 02 2003 10 55 59 Questa una nota abbast 0001958 Barnard Paolo Mal 28 02 2003 10 56 00 Questa una nota abbast 0009850 Nei Fabio Mal 03 03 2003 10 39 57 Questa una nota abbast 0007879 Rossi Luca Mal 03 03 2003 10 40 00 Questa una nota abbast 0008446 Lanti Paolo Mal 03 03 2003 10 40 00 Questa nota abbast 0008246 Lanti Nicola Mal 03 03 2003 10 40 01 Questa nota abbast 0002360 Lanti Luca Mal 03 03 2003 10 40 02 Questa una nota abbast 0006475 Bianchi Mari Mal 03 03 2003 10 40 02 Questa nota abbast 0006275 Bianchi Nicol Mal 03 03 2003 10 40 03 Questa nota abbast 0008013 Verdi Francesi Mal 03 03 2003 10 40 05 Questa nota abbast 0001928 Rossi Matteo Mal 03 03 2003 10 40 06 Questa nota abbast 0005042 Barnar d Mari Mal 03 03 2003 10 40 07 Questa nota abbast 0009552 Claro Paolo Mal 03 03 2003 10 40 08 Questa nota abbast 0002095 Rossi Matteo Mal 03 03 2003 1 0 40 09 Questa una nota abbast 0006209 Barnar d Paolo Mal 03 03 2003 10 40 09 Questa nota abbast 0006783 Verdi Matteo Mal 04 03 2003 8 09 28 Questa amp nota abbast 0006583 Doh Nicola Mal 04
90. 23 H 68 27 Packaged Instrument s Dimensions L 120 cm 48 D 80cm 32 H 80cm 32 Packaged Accessories Dimensions L 120 48 72 29 H 70 28 ANALYZER POWER REQUIREMENTS Universal Input 90 240 V 50 60 Hz Power 590 Watt PFC Unit Power Factor Correction included VACUUM PUMP POWER REQUIREMENTS New Vacuum Pump System P N 06 05161 01 Input 90 240 V 50 60 Hz Power 60 Watts Previous Vacuum Pump System P N 662 0788 OBSOLETE Input 220 V 50 60 Hz 110 V on request Power 80 Watts 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 Watts ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY The BT3000 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 BI3000 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
91. 5 Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 6 of 23 1 3 2 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 n ncc hier TUE Daily Chart graph EUN SU Analyses BIC Lot Method TRINDER Type Known Level Daily Control Level m Figure 7 By clicking the mouse over a given value in the graphic its information will be displayed Click Print to print the graph Westgard graph Analyses Date ime BIC 12 200 12 21 Method Level TRINDER i Type Known 230 Out of limit Figure 8 Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 7 of 23 1 4 ADDITIONAL FUNCTIONS P Quality Controls Export data Functions Preference Selection Export Data Alt E Analyses All Data Delete Data For Data
92. 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 0 to 2 000 O D 2 5 at 2 400 O D Section I Chapter O Technical Specifications BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 6 Photometric Sensitivity 0 0005 ABS Drift 0 005 ABS h steady state Optical path 7 mm Photometric Lamp Tungsten Halogen Lamp with Dichroic Reflector 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 F S Full Scale Accuracy at 3 ul 3 Accuracy Full Scale 0 1 from 10 ul to 470 ul 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 VOLUMES WORKING SOLUTIONS Clinical Chemistry Reaction Volume 280 ul minimum 700 ul max double reagent Sample Volume from1 to 100 ul ISE Concentrated Buffer Solution 50 ul 400 ul H20 Concentrated Reference Solution 50 ul 400 ul H20 Sample Volume 30 ul Concentrated Buffer 10 ml 200 tests Concentrated Refer
93. D 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 e AP Go Ge Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 23 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 TEE 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 Installing Devices Setup is detecting and installing devices on your computer CAUTION DO NOT INTERRUPT THIS OPERATION Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 23 Now the Setup asks for setting the correct date and time for the system One may skip this
94. E Module BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 17 1 4 REPLACING AND INSTALLING ELECTRODES The analyzer is supplied with the electrodes already installed in the ISE module To replace or install the electrodes the analyzer must be turned off and then the following steps must be observed WARNING Do not touch with bare hands the small metallic tubes of the electrodes the contacts of electrodes or the sensor electronics in order to avoid electrostatic discharges that may cause permanent damage or system malfunction Thumbscrew securing Metallic shield Pump Cartridge Dilutor Pinch Valve Dilutor Peristaltic Pump Figure 10 1 Before installing or replacing electrodes remove the ISE module as shown in Figure 10 and unscrew the thumbscrews securing the metallic shield 2 Disconnect the tubes 2 3 4 and 5 Figure 11 from the electrodes Remove the housing containing measurement electrodes Na Cl By pass or by gently moving leftwards Figure 11 Remove the housing containing Reference and Ground electrodes by carefully moving it rightwards Keep these housings in vertical position when electrodes are present Carefully remove the electrodes from their respective housings by gently pressing on the backside Always maintain the electrodes stack in vertical position It is recommended to immediately disconnect the first electrode K from the next one Replace the defective electrodes with new ones Reass
95. E WASTE PROBE 2 CONTENITORE DI SCARICO ESTERNO EXTERNAL WASTE CONTAINER VACUUM PUMP SYSTEM Installation FIGURE 1A Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 19 Section I Restart Push Button Hydrophobic Filter P N 662 0807 REPLACE FILTER EVERY 6 MONTHS Silencer P N 330 9625 Pump Cartridge P N 330 9088 REPLACE CARTRIDGE EVERY 6 MONTHS Elbow Fitting P N 330 9623 USER SERVICEABLE SPARE PARTS FIGURE 2A WASTE PROBE P N 662 0788A amp B FIGURE 3A Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 18 of 19 Always connect the tubing to the analyzer Do not use the Vacuum Pump System and Waste Tube with any other fluid source direct suction of liquid from any container or cleaning of any laboratory spillages The unauthorized use may result in serious injury to the user and permanent damage to the Vacuum Pump System Always unplug the power cord from the unit before performing any installation or maintenance procedure Remove Transit Screws at the bottom before operating during the analyzer operation WASTE CONTAINER WASTE WE or standby The Waste Probe CONTAINER a must always be kept on the m onm 0285 Waste Container to avoid E waste liquid spillages VACUUM PUMP SYSTEM WARNINGS FIGURE 4A Section 1 Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page I9 of 19 D
96. ECURE GROUND CONNECTION FAILURE TO DO THIS MAY CAUSE ELECTRIC SHOCK OR INJURY THE VACUUM PUMP SYSTEM MUST NOT BE DISMANTLED OR REPAIRED BY ANYONE WHO HAS NOT BEEN QUALIFIED BY THE MANUFACTURER INCORRECT WORK MAY CAUSE FIRE OR IRREPARABLE DAMAGE TO THE VACUUM PUMP SYSTEM 2 13 FUSE REPLACEMENT MAINS POWER INLET MODULE The mains power inlet module has a built in fuse holder and two fuses of 250 Volt 2 AT P N 330 6340 230 VAC pump or 250 Volt 4 AT P N 330 6342 115 VAC pump Fuses protect the system against power surges and overload by interrupting power Replace fuse s as marked on the rear panel To replace the fuse proceed as follows 1 Disconnect the power cord Remove the fuses by gently extracting the fuse holder with a tool The fuse holder has two grooves on the sides for tool accessibility only 2 Discard the old fuses and replace with new fuses which match the selected voltage rating indicated on the back panel label 3 Insert the fuse holder into the compartment and push until its latch snaps back into position 2 14 FILTER REPLACEMENT 1 2 3 Disconnect the power cable Loosen the cover screws and remove cover Remove the Filter tubing blue from the waste chamber and the vacuum pump quick connects Discard the filter Install a new filter by connecting longer tubing filter outlet to the quick connect on the vacuum pump The arrow indicator on the filter must point towards the air intake of the
97. FICATIONS 230 VAC 50 Hz or 117 VAC 60 Hz As per Clients disposition 85 265 VAC Switched Mode AC 47 63 Hz 24VDC 10 0 to 50 C Linear motor driven free piston oil less 230VAC 50 Hz or 115VAC 60 Hz As per Clients disposition Automatically regulated by Vacuum Limit Valve factory set at 400 mbar 40kPa 300 mmHg 11 8 in Hg Located downstream of the Hydrophobic Filter 800 mbar 80 kPa 600 mmHg 23 6 in Hg Direct Current Motor 24 VDC 3000 RPM 110 ml min PharMed Bore 23 2 mm Friction transfer of nominal speed directly onto the rollers Analyzer waste NOTE It is recommended that the Pump Cartridge be changed every 6 months Liquid Level Float Switch with hermetically sealed magnetic Reed Switch and permanent magnet Disposable hydrophobic bacteria filter NOTE It is recommended that the filter be changed every 6 months 310 mm 12 2 inches 230 mm 9 1 inches 420 mm 16 54 inches 15 kg 33 1 Ibs Meets EN 55011 EN 50082 1 For conducted and radiated emission Conforms to Council Directives 98 79 EEC of 27 October 1998 1 year including parts and labor excluding Consumables The Biotecnica Instruments S p A reserves the right to alter technical specifications without prior notice Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 19 2 9 CAUTION SHIPPING RETAINER VACUUM PUMP SYSTEM TO PROTECT THE VACUUM PUMP FROM VIBRATION AND IMPACT DURI
98. FLAGS During a calibration or a run an error message Air bubbles may appear The error may be momentary and not appear afterwards In this case it means a casual formation of bubbles If it persists then it may be due to problems of hydraulic nature a ISE funnel takes long time to empty It may be caused by defective or worn peristaltic pump for draining or an obstruction in the electrodes stack Repair or replace b Prime operation failure The Prime also calibrates the bubble sensor Check that prime is performed properly c Collapsed tube in the ISE pinch valve The Baseline solution doesn t enter the Reference electrode and the funnel doesn t empty The Reference electrode is filled during the prime Check and correct Results with flag D During the reading the flag D on one or more electrodes indicates a drift of potential greater than 2 mV The phenomenon may be determined by one of the following causes Defective electrode Electrode to be reconditioned Partial occlusion of the electrode Incorrect reagents No washing after a consistent run Correlation with general problems already explained Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S Page 15 of 17 NOTICE CHLORIDE ELECTRODE NEEDLE TOOL P N 03254 It is often possible to extend the life of a chloride electrode by using the supplied CHLORIDE ELECTRODE NEEDLE TOOL 1 Grasp the NEEDLE TOOL as shown Gently insert the tip of t
99. Figure 9 positions to display Insert re run timing screen Figure 9 Here one can enter interval of hours or days refer to Chapter C paragraph 1 4 for automatic controls run uumuaumm mamasuuuuanuuuuuauauas upon Date daily interval Select the function and set daily interval then enter test running time for example 1 08 30 means every day at 08 30 or in any case at start up upon Hour hour interval Select the function and set the desired hour 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 View used positions This command displays the test disposition NOTE Enter the same parameters also for Level 2 and 3 controls UNKNOWN CONTROLS The only parameters to be set are the lot name or number the sample position on the sample tray and the timed re run for each level Reserved positions are located in the inner circle of the sample plate and are dedicated to the calibrators and controls The numerical positions on the sample plate correspond to those already set in the program Setup Analyzer refer to Chapter H paragraph 2 Setup Analyzer After programming all the parameters save parameters by clicking Save button Click Print for hardcopy printout of control parameters Section I Chapter L IS
100. G 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 ERIBIBIER 2 Typ Known Lot Unknown EA 0571272001 Method j BICROMATO oe K Memorize Lot Date Time Value 14 2 200 11 36 o a Memorize Qe Figure 2 SectionI Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 23 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 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 con
101. HAPTER I 1 BARCODE AND RELATED FUNCTIONS 2 USING THE BARCODE 2 1 Barcode on Samples 2 2 Barcode on Reagents CHAPTER K 1 VACUUM PUMP SYSTEM INSTALLATION OPERATION 1 1 Functional characteristics 1 2 System control functions 1 3 Waste container external 1 4 Installation and operation 1 5 Maintenance and care 1 6 Trouble shooting 1 7 Spare parts for maintenance 2 VACUUM PUMP SYSTEM P N 662 0788 amp BYPRODUCTS OBSOLETE No longer in production 2 1 Introduction 2 2 Technical description vacuum pump Index BT3000 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 e et et Sk OI C9 amp NM O Ah BR RW W INDEX BT3000 PLUS Operator Manual 2 3 Principles of operation 2 4 Vacuum gauge 2 5 Vacuum level regulator 2 6 Hydrophobic filter 2 Warnings 2 8 Technical Specifications 2 9 Caution Shipping retainer Vacuum pump system 2 10 Installation 2 11 Quick start up 2 12 Care and maintenance 2 13 Fuse replacement mains power inlet module 2 14 Filter replacement 2 15 Peristaltic pump c
102. How to run a Query Select Analysis Select Methad Group Test Type Date Range DOM vi M D From To v Male Serum f Female Urine Results Range v Chid v Relation EN Num of Rec Standard Deviation Variance Correlation Coefficient Min Result 43 0 736 0 542 0 114 5 000 Mean Variation Coefficient Deviance Median Max Result 6 598 11 16 22 75 6 500 7 800 Group Test Type M D 5 300 06 02 2002 Female Serum M D 6 200 06 02 2002 Female Serum M D 6 300 06 02 2002 Female Serum M D 5 400 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 5 500 06 02 2002 Female Serum M D 5 200 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 x 4 14 Print Preview Exit Figure 13 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
103. ION 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 KINKS 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 C
104. IRCUIT 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 M Warnings and Precautions BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 6 30 31 32 33 34 35 36 37 38 39 40 41 42 43 THIS LAMP EMITS UV ULTRAVIOLET RADIATION PROLONGED EXPOSURE TO THIS LAMP MAY CAUSE SKIN AND EYE IRRITATION THE ANALYZER SYSTEM MUST NOT BE DISMANTLED 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 USE
105. L BT3000 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 IT Chapter 8 List of Applicative Methodologies BT3000 PLUS 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 II Chapter 8 List of Applicative Methodologies BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 2
106. LED 4 m WATER CLEANING TOOL P N 03254 REFERENCE REFER TO INSTRUCTIONS IN SOLUTION THE FIGURE 13 a D Na Sodium a eclode K Potassium 4 Electrode CI Chloride Electrode 4 4 CO Carbon a Dioxide eis R E pM VTL Flectrode CLEANING PROCEDURE Carefully insert the tip of 5ml 10 ml syringe filled with appropriate solution onto the top duct of electrode GS assembly as shown Zi x Inject solution until all the solution is forced through interconnecting bores of the electrodes and flows out from the bottom electrode thus thoroughly removing any contamination WARNING PUSH THE PLUNGER ONLY TO EJECT THE SOLUTION DO NOT PULL THE PLUNGER TO ASPIRATE THE SOLUTION INSIDE ELECTRODES THIS WILL CAUSE IRREPARABLE DAMAGE AND CONTAMINATION TO THE POTASSIUM ELECTRODE WITH CI OR CO PARTICLES DO NOT USE PLASTIC STRING FOR CLEANING THE REFERENCE OR Na ELECTRODES AS IT MAY DAMAGE THE ELECTRODES INTERNALLY ISE ELECTRODES CLEANING PROCEDURE Figure 14 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S Page 17 of 17 OPERATOR MANUAL BT3000 PLUS SECTION I GENERAL INFORMATION CHAPTER M 1 WARNINGS AND PRECAUTIONS 1
107. NG SHIPMENT IT COMES INSTALLED WITH A CLAMPING DEVICE WHEN YOU UNPACK YOUR VACUUM PUMP SYSTEM MAKE SURE TO REMOVE TWO TRANSIT SCREWS COLORED RED AT THE BOTTOM OF CABINET TO RELEASE THE VACUUM PUMP TURNING ON THE PUMP WITH THE TRANSIT SCREWS INSTALLED WILL MANIFEST ITSELF INCREASING THE APPARENT NOISE LEVEL DURING OPERATION AND MAY DAMAGE INTERNAL MECHANISMS 2 10 INSTALLATION Refer to Fig 1A Install all electrical cables and tubes as follows 1 2 2 11 1 2 3 Remove the transit screws at the bottom of the pump cabinet Connect waste tubing from the right side of the analyzer to appropriate quick connects on top of the vacuum pump cabinet Connect the liquid level detector cables and the drain tubes of Waste Probes to the vacuum pump cabinet front panel Insert the Waste Probes in authorized external waste containers Plug the power cordset to power inlet on the vacuum pump cabinet and then into one of the accessory power connectors on the analyzer rear panel QUICK START UP owitch on the analyzer The vacuum pump will start running Maximum operating vacuum is preset at 400 mbar 10 The vacuum level during unit s normal standby operating mode may vary between 100 mbar 5 mmHg to 300 mbar 225 mmHg In case the vacuum level drops below 100 mbar then refer to Paragraph 12 1 14 entitled Trouble Shooting Guide NOTE The waste probe LED and audible alarms keep you aware of the unit s status as f
108. ON is built into the operative software continuously monitors the analyzer system for correct operation Besides clinical chemistry and immunochemistry tests it is equipped for ions determination for Na CO2 upon request with ion selective electrodes ISE Module lon Selective Electrodes The analytical throughput is 330 tests h for clinical chemistry 205 tests h for the ISE Module including without I S E module 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 plus 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 The positive barcode identification of reagents position eliminates any possible error during the positioning of bottles t is possible to perform repetitions upon operator s request or automatically pathological results Incase 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
109. OOTING If the routine maintenance is performed regularly the ISE module functions correctly The most common problems encountered in the ISE Module are as follows a Calibration errors b Unreliable sample results with flags C Error messages of air bubbles a CALIBRATION ERRORS The causes may be due to various reasons and can be diagnosed through close examination of mV values of slopes Typical values of calibration potentials in mV K std low 8 mV std high 22 mV difference 30 mV slope 57 mV Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S Page 13 of 17 Na stdlow 10mV difference 15mV slope 63 mV std high 5 mV CI std low 6 mV difference 10mV slope 50 mV std high 4 mV stdlow 4 mV difference 10mV slope 32 mV std high 6 mV The above mentioned values are indicative and may deviate due to the wear and tear of the electrodes A positional error or an incorrect concentration of reagents may determine a considerable variation of potentials and slopes The mV values in brackets in the calibrations printout can give additional indications which are useful for the diagnostics For example Std low 8mV 208 200 Std high 22mV 178 200 One can observe in the above example the Baseline value 200 which must be always included between two Std values In fact the value 200 is between the two values 208 and 178 Various combinations of error a Inversion of Buf
110. OPERATOR MANUAL BT 3000 PLUS cod MO 04444 05 ING SOFTWARE VERSION 8 Rev 0 04 10 2004 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Tel 39 06 4112316 Fax 39 06 4103079 E mail Website INDEX BT3000 PLUS Operator Manual 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 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 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 CHAPTER E 1 OPERATIING PROCEDURE 1 1 Turning on procedure 1 2 Reagents insertion and removal 1 3 Running Stand
111. R 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 USE VACUUM PUMP UNTIL THE TWO TRANSIT SCREWS COLORED RED AT THE BOTTOM OF CABINET HAVE BEEN REMOVED OLD VACUUM PUMP SYSTEM P N 662 0788 AND BY PRODUCTS 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 OR THE VACUUM PUMP 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 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
112. Replace peristaltic pump cartridge as explained in the preceding a Reading Station Replace tube DA connecting the peristaltic pump through pinch valve to the dilutor Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 16 Carefully lower the ISE electrodes panel back into place ensuring that the tube is free and not pinched or crushed by the panel After replacing tubes and accessories turn on the analyzer Insert the plastic lodging with the reagent bottles containing appropriate products and run a few times the function Dilutor prime and Prime I S E refer to Chapter H paragraph 1 1 1 to prime the hydraulic circuit c Vacuum Pump System From June 2004 onwards all BT3000 PLUS family analyzers are supplied with a new vacuum pump system Its performance characteristics are identical to the previous model For detailed description and installation instructions refer to Chapter Section I Vacuum Pump System Installation Operation This compact pump system is virtually maintenance free and offers continuous duty collection of waste liquids outside the analyzer Does not require inconvenient peristaltic pump cartridge and filter changes The theoretical operating life of the pumps is between 4000 to 5000 hours after that the service technician should substitute the pumps WARNING a DISPOSABLE GLOVES MUST BE WORN WHEN SERVICING THE VACUUM PUMP SYSTEM WHERE HANDS MAY CON
113. S amp by products Figure 9 WASTE PROBE The waste probe shown above should be inserted directly into the waste container for waste liquids collection Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 8 of 10 1 3 STARTING THE INSTRUMENT 1 3 1 TURNING ON THE INSTRUMENT FOR THE FIRST TIME Turning on procedure for the first time 1 Turn on the UPS device as described in the appropriate supplied manual 2 3 4 5 6 Fig 10 Power on the printer refer to the specific manual enclosed 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 LCD display Figure 10 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 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 After turning on the system there is an access password requirement Refer to Chapter E paragra
114. 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 Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 15 of 19 c Surname 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 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 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 session
115. Status Used to Insert Remove Reagents F10 Password F7 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 Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 11 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 5 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 aborts the programming and closes the
116. TACT POTENTIALLY CONTAMINATED WASTE MATERIALS 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 Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 16 WASHERIDILUITOR SYSTEM BT 3000 PLUS READING STATION Il S E MODULE BT3000 PLUS Figure 2 BIMONTHLY MAINTENANCE KIT P N 662 1016 ITEM DESCRIPTION Diluter Pinch Valve Tube ISE ISE Pump Tube Interconnection Tube for GND Bypass OR CO2 Electrode 8 REF Tube Manifold Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 16 SIX MONTH MAINTENANCE KIT P N 11 05219 01 ITEM 2 ANNUAL MAINTENANCE P N 11 05220 01 ITEM QTY 2 7 Table of Figure 2 LT 6 LL O1 4 Go gt 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 see Figure 3 4 amp 5 lt 8 3 Figure 3 Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 16 REPLACING THE HALOGEN LAMP Figure 5 Precautions for handling the ha
117. TOCOL 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 to 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 Initiate analysis data Analysis data true and typical 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 N
118. The shut down procedure proposes the wash of the cuvettes as well as the ISE Module 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 As regards the ISE Module the two dedicated solutions must be placed in the lodging for the ISE reagents see Chapter L There are two additional modes for interrupting analyzer 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 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 t
119. Ver 8 Page 15 of 23 Click Yes on the Monitor Settings Monitor Se ttings 718 Default Monitor c ra 75 nd d Tech t Programs Folder Options Fonts Mouse Display Properties Jemove Add Remove Administrative Programs Tools a Click Power at the bottom right Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 23 Select the settings Never in Turn off monitor and Turn off disks Power Options Properties amp peu Settings for Home Office Desk H e Add Remove Administrative Programs Tools Tum oll monto i 5 lt 4 Y Li 7 um olf hard disks gt 15 M Folder Options Click OK If one desires to select a background picture go to Background page 1 move Add Remove Administrative Programs Tools a Folder Options Fonts HRAPPERIGUDICIEES My Computer lke My Compu y oelect the desired background picture and set Stretch in the Picture Display Click OK Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 23 If a question is asked then respond by clicking Yes SAINT 3 The Operating System is now configured correctly and one may proceed to the installation of the drivers of the peripheral device
120. able analyses list will then appear select the tests to be associated and store with Save command Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0O Soft Ver S Page 25 of 32 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 possible 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 par
121. age W INDEX BT3000 PLUS Operator Manual SECTION Il SUPPLEMENTARY INFORMATIONS CHAPTER 1 1 ABBREVIATED OPERATING INSTRUCTIONS 1 1 Turning on and preliminary procedures 1 2 Inserting Reagents in Clinical Chemistry and ISE 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 CHAPTER 2 2 WARRANTY CONDITIONS CHAPTER 3 3 ORDERING INFORMATION 3 1 General terms and conditions for sale 3 2 Consumables for BT3000 PLUS 3 3 ISE Module consumables CHAPTER 4 4 SOFTWARE 4 1 Serial Communication between BT3000 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 BT3000 PLUS Operating Program 5 6 Upgrading the BT3000 PLUS software CHAPTER 6 6 TECHNICAL ASSISTANCE CHAPTER 7 7 BIBLIOGRAPHY OF ALLIED SUBJECTS CHAPTER 8 8 LIST OF APPLICATIVE METHODOLOGIES Index BT3000 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 Page Page Page Page Page Page Page Page Page C Jon OPERATOR MANUAL BT3000 PLUS
122. age Section I Chapter I Barcode and Related Functions Index BT3000 PLUS Rev 0 Soft Ver 8 IN 1 BAR CODE AND RELATED FUNCTIONS The software for the BT3000 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 BT3000 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 LL 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 Samples and through barcode scanning using the Profile utility refer
123. age no longer appears then it is possible to continue testing In case the error message still persists contact approved technical 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 messages that are not covered here or are not clear please contact Technical Assistance Dept at Biotecnica Instruments S p A Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 16 OPERATOR MANUAL BT3000 PLUS SECTION I GENERAL INFORMATION CHAPTER O 1 TECHNICAL SPECIFICATONS Page 2 NOTE Specifications are subject to change without notice Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter O Technical Specifications Index BT3000 PLUS Rev 0 Soft Ver 8 1 TECHNICAL SPECIFICATIONS PERFORMANCE Operating Mode Random access Methods Tests for Clinical Chemistry and Immune Chemistry ISE Module Na K Cl CO optional Test Mode Routine Batch Emergencies STAT Profiles Tests on line 80 refrigerated reagents Relation Tests Tests in memory 900 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 of related profiles or on demand Measurement direct reading of 34 cuvettes in optical glass Sample Tray C
124. al ABS Max ABS Delta and Check Prozone are different for serum and urine see Fig 19 and 20 1 3 5 SECONDARY ANALYTICAL PARAMETERS Primary parameters Check Parameters Secondary parameters Serum Urine 1st Unit Name Factor NAR 0 000 Dynamic Blank Number of needle washes 1 fi r Number of cuvette washes Shift 0 000 Instrumental Factor 0 000 Reagent Bank C Every run Decimals Every day C Automatic fe up Hour Custom Hour Minute 0 12 0 m 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 4st 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 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 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
125. alyses 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 Restore 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 Di
126. ameters 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 XXX Known run Known Lot name Lot name Lot name C nsert re run timing m I si Sample position 21 si Sample position 0000 Low alue Value 0 000 Theoretical Value 0 000 Theoretical Value High Value 0000 High Value Timed re run V Timed re run Levelft f Level 2 f Level 3 Level 3 iLevel t f Level 2 Level 3 Level 3 01 08 30 Timed r
127. amples Infra Run Serum N 20 samples Accuracy for Urine test Intra Run Urine 20 samples Infra Run Urine 20 samples Life expectancy for electrodes 4 plus Reference Electrode and CO on command 70 seconds 51 Samples hour 204 Results hour K Na and Buffer and Reference Solution concentrated Serum Urine whole 30 ul 1 10 with H2O automatically 1 14 automatically 196 for K amp 2 for 396 for CO 2 for K Na and Na 50 200mEq L K 1 20mEq L CI 50 400mEq L CO2 10 45mEq L Na 20 400mEq L 2 200mEq L Cl 40 400mEq L Na and C V 196 lt 2 CO C V lt 5 Na and C V 296 lt 2 5 lt 5 C K and V lt 2 C V lt 2 5 Na and Reference Electrode 12 months 3 months Cl amp CO 3 months RUNNING TIMES FOR UTILITY Wash amp Fill Up Wash H O Zeroing Extra Wash ISE Extra wash cuvette Wash Shut Down WASHES 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 ISE Washes H20 per test ISE extra wash Section I Chapter D Performance and Limits 2 0 seconds approximately 180 seconds approximately 420 seconds approximately 900 seconds approximately
128. ancel to exit this page Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page4 of 17 SERUM S PARAMETERS Here it is possible to assign the Normal range Figure 5 for each General Parameters Serum s Parameters Urine s Parameters Normal range n ax electrode and if needed the panic range for 3 50 5 00 500 woman pathological repetition The programming of the 3 50 5 00 Child QO T normal range values for Man Woman and Child is assigned specifically to each electrode Seeoscossessessessdbesesssssessessssi tt r Panic range 6 To assign panic range to each poo 5000 woman en electrode click corresponding tag nono 0 To visualize the Panic range click Re run BS OEY CF pathological checkbox If Re run pathological option is selected the analyzer will repeat all pathological results outside the given range Figure 5 Parameters for 1 5 Tests General Parameters Serum s Parameters Urine s Parameters O Seessosesssssssssedbesssssesssessess i b eeseosed URINE S PARAMETERS In addition to the tt same functions as the Serum s Parameters it qe is also has the pl Water field Figure 6 This is a Tm
129. and SET Section IT Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 18 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 error codes description and the possible causes Error Code Possible Causes An invalid command has been inserted in the Unknown command 9 commands of script A cimus ACE 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 uen 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 otring 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 tr
130. 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 2 5 End Point 2 Points This method only for single reagent tests is used whenever it is required to eliminate from the reaction the interference 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 eo 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 Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver S Page 13 of 32 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 50750 10710 etc The End Point Fixed Time Kinetic and IR methods allow bot
131. ange 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 Section Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver amp Page 5 of 8 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 first 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
132. ansmission 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 in the b A different value from ANALYSEDATA SET command 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 II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 18 TABEL 1 TRANSMISSION The following variables are used for the transmission of a report from analyzer to the host computer PATIENTCODE Patient Code otring PATIENTNAME Patient Name otring PATIENTSURNAME Patient Surname otring PATIENTGROUP Group 1 String Character PATIENTLISTTYPE List 2 String Character PATIENTTYPE Method Type String Character PATIENTNOTE Descriptive Note String PATIENTNUMBERTEST Number of Results String Character CHECKSUM Ch
133. apacity 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 11 seconds Analytical throughput 330 tests hour single reagent Test processing time max 360 seconds ISE PROCEDURE ISE Test processing time 70 seconds Executive throughput 51 Samples hour Analytical throughput 204 Results h K Na CUVETTE OPERATING TEMPERATURE Programmable Temperatures Room Temperature 32 C and 37 C Precision 0 2 Accuracy 0 2 Temperature Monitoring Device based on Peltier Effect REAGENT CHAMBER TEMPERATURE Nominal Temperature 11 Approx Temperature Monitoring Device based on Peltier Effect OPERATING AMBIENT TEMPERATURE 18 C to 32 C 10 to 90 RH Non condensating Section I Chapter O Technical Specifications BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 6 DIMENSIONS AND WEIGHT NOTE weight and dimensions shown are approximate Packaged Instrument 135 Kg 298 Ib Packaged Instrument with Accessories 225 Kg 496 Ib Packaged Accessories 90 Kg 199 Ib Instrument s Dimensions L 100 cm 40 D 58cm
134. ard and Controls on demand or timed 1 4 Samples 1 5 Work Lists 1 6 Turning off procedure 1 7 Access password Index BT3000 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 Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page ob SOOO RWN omy ovovonmmv Oo 12 16 INDEX BT3000 PLUS Operator Manual 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 1 3 1 Westgard Graph 1 3 2 Daily Chart Graph 1 4 Additional Functions 2 POPULATION 2 1 Analysis Selection How to run a Query 2 2 Principal statistics formulas used in Population module 2 3 Diagrams 2 4 Inserting external analyses 2 5 Other menu functions 3 PATIENTS ARCHIVE 3 1 Selection How to run a Query 3 2 Patient s report 3 3 Printing Reports 3 4 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 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 C
135. artridge replacement 2 16 Trouble shooting guide 2 17 Cleaning of the hydrophobic filter 2 18 User serviceable spare parts CHAPTER L 1 1SE MODULE Introduction Parameters Programming Standards and Controls Replacing and Installing Electrodes Preliminary steps before starting the system Calibration procedure Measuring unknown samples 8 Precautions for ISE Module usage 1 9 Suggestions for performance maintenance 1 10 Troubleshooting CHAPTER M 1 WARNINGS AND PRECAUTIONS 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 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 O 1 TECHNICAL SPECIFICATONS ep e ONOURWH Index BT3000 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 Page Page Page Page Page Page Page Page P
136. ary parameters Check Parameters Secondary parameters Serum Urine Save Code N AA ame Print Test methodology Urine pl Serum Urine Method End Point EHE E Dilution Kind of process 8 Sample D n si Pre Dilution 1 Linear Rd 1st Filter 2nd Filter fi Post dilution 1 20 Omes gt 3 Method End Point dii Reagents E Dilution Kind of process fi Pre Dilution 1 lines I lg Sample E 1st Filter 2nd Filter fi Post dilution 1 40 wow _ E Reaction direction ncreasing I C Decreasing Bwm Reaction direction Increasing C Decreasing deeem C None C None Figure 17 Figure 18 Section I Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver S Page 21 of 32 Serum Parameters Fig 17 e Name Enter the complete name e Serum pl Sample volume expressed in ul 100 ul max e Dilution In this screen two fields are available Pre Dilution 1 predilution ratio and Dilution 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 Pre Dilution 1 Set sample s pre dilution rat
137. assigned analyses codes Patients Tes Utility F 03 02 10 20 31 ae C mBar Figure 14 Section 1 Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 15 of 19 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 as well as the ISE Module 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 As regards the ISE Module the two dedicated solutions must be placed in the basket for the ISE reagents see Chapter L 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 user s 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 turn
138. at 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 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 Th
139. ata 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 Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 23 of 23 OPERATOR MANUAL BT3000 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 Page Page Page Page Page Page Section Chapter G Displaying and Printing Results Index BT3000 PLUS 0 Soft Ver 8 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 resul
140. ation port not found cable disconnected no processor etc the following screen Select communication port will appear Mf fbt Plus Setup E E A deo rn Dae S 3 n Ese cut gt gt at a4 Feed Comunication um C ES 1 Com2 Comunication not fouded on current analyzer 1 Com3 Please select the comunication port manually Com4 Astart w e Ebt Plus Setup lt 9 27PM 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 LA EEE lt lt xf TT inp E A Setup Status bt Plus Setup is performing the requested operations Copying help files C Program Files 4nalpzer Help 8T OPERATIVE Installing Cancel 5 A e tJ Ebr Plus Setup IE 3 29 PM Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 20 of 23 After the termination of previous phase a message Setup has finished installing bt Plus your computer will be displayed InstallShield Wizard Complete Setup has finished installing bt Plus on your computer i start w 51 EMbt Plu
141. 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 Diagrams for DOM Histogram Stat Histogram Num of Rec Standard Deviation Variance Correlation Coefficient 43 0 736 0 542 0 114 Median 6 500 Mean Variation Coefficient Deviance 6 598 11 16 22 75 Exit Figure 14 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 Chapter F Population Patient s Archive PLUS _ Rev 0 Soft Ver 8 Page 10 of 23 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 in the lowe
142. be disconnected before ISE module removal If the module is removed from it s lodging the ISE arm will be inoperative Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page2 of 17 Funnel or bowl Pinch valve Na Electrodes Mm Electrode Biot in 2 NS NS E S 4 E 7 EI Potassium iotecnica RU EL struments SpA Reference electrode 2 5 p 5 ct 2 Be fre 1 By pass Electrode T ej E or optional 2 amp By pass IE Electrode j Biotecnica Instruments S pA 1 Ground Electrode 1 1 2 PARAMETERS fit BE 2000 Ake Modify analytical parameters Modify analytical 4 Current Tray parameters All Tests Go to Test Parameters Standards and Controls Global page Figure 2 or the Test Parameters Standards and Controls Current Tray page Figure 3 Select ISE and then click Parameters to display the screen showing analytical parameters for the ISE General Parameters Serum s Parameters and Urine s Parameters The General Parameters is displayed first Figure 4 to access the other parameters click on the corresponding tags Test Parameters Standards And Controls Global Print parameters Print Controls Print Standards AiG ac BT CkmB FA GOT LDH PRO Bg Bi cio FANP tb T RF E o po 6 FaPR f HBDH
143. bration 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 Calculati 1069 hoo lute Number of samples 2 zi 10 lo Timed re run Last Standardization Reagent 5 lt Not Performed gt Number Pos Conc ABS 3 200 0 000 fi q 4 from last calibration e View used positions Linear Print 1 Enable Auto Adjust Save 9 Cancel Figure 26 Calibrators or standards used must be placed into dedicated positions on the 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 calibra
144. c reaction If the initial phase in unstable the regression line is computed by eliminating the points outlying it from 4996 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 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 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 12 of 32 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 2 5 The two reactions are distinct and separate
145. cations 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 analyzer BT3000 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 O Technical Specifications BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 6 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 1 1 ABBREVIATED OPERATING INSTRUCTIONS 1 1 Turning on and preliminary procedures 1 2 Inserting Reagents for Clinical Chemistry and ISE 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 FOREWORD Page Page Page Page Page Page Page Page NOGUN 10 14 19 This quick guide gives a global view of the system operation by outlining the sequence of fundamental operating phases t is highly recommended to carefully read these instructi
146. ce Histogram 0 013 6 308 m ES Stat Histogram Num of Rec Standard Deviation Variance Correlation Coefficient 43 0 735 0 542 0 114 Mean Variation Coefficient Deviance Median 6 598 11 16 22 fis 5 500 Di Print Preview O Exit 43 U 3b 0 942 0 114 sz Mean Variation Coefficient Deviance Median 5 538 11 16 22 75 6 500 Print Preview Exit Figure 19 By clicking Histogram button the histogram for the selected data is displayed Fig 19 By double clicking the mouse on a given plotted point information about its coordinates position and value is shown Fig 16 Section Chapter F Population Patient s Archive PLUS Rev 0 Soft Ver 8 Page 14 of 23 Statistic Histogram Graph Diagrams for DOM Data Sequence Trender Lag L J Histogram AE Stat Histogram Num of Rec Standard Deviation Variance Correlation Coefficient 43 736 0 5 0 114 Mean Variation Coefficient Deviance Median 6 598 11 16 22 75 6 500 Print Preview O Exit 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 2 4 INSERTING EXTERNAL ANALYSES Add New Analysis Analysis Mame Analptical
147. ce 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 M Warnings and Precautions BT3000 PLUS 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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see Chapter N Mai
148. chnical assistance Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 14 of 16 SCREEN MESSAGE CAUSES amp REMEDIES This message stops the execution of programmed ERROR RESETTING ARM tests The message ERROR RESETTING ARM ARM HORIZONTAL HORIZONTAL is generated by a defective position sensor of the arm Press F5 Reset key ERROR RESETTING LS E to restore the correct analyzer operation If the problem persists then contact approved technical ARM HORIZONTAL assistance This message stops the execution of programmed tests The message ERROR RESETTING ARM ERROR RESETTING ARM VERTICAL is generated by an error during VERTICAL up down motion the sampling needle This error may be caused by a deformed needle obstructions i e improper placing of the reagent bottles or a defective ERROR RESETTING ARM position sensor If the needle is deformed replace it LS E VERTICAL 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 If the message persi
149. ct 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 M Warnings and Precautions BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 6 OPERATOR MANUAL BT3000 PLUS SECTION I GENERAL INFORMATON CHAPTER N 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 N Maintenance amp Troubleshooting Index BT3000 PLUS Page Page Page Page Page Page Page Page Page Page Rev 0 Soft Ver 8 1 MAINTENANCE 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 T
150. d Low 310 108 Standard Low High Double Standard High 10 2 35 0 clicking the appropriate fields one can program the concentration values of the two standards for each electrode Every time standards are changed the set points must be changed as well Refer to the kit insert or to the standards label for the correct values 0 000 BSF This parameter is a Base Line Factor and is used only for It must be set to 10 It is a linearity correction factor Slope Min Slope Mas 46 0 162 aen 130 View used positions This command shows all the positions used by standards INSERTING CONTROLS Unk 3 4 Go to Test Paramete rs Lot name Standards And Controls rd Global page Figure 2 Or the Test Parameters Mis Standards And Controls amm 1 Current Tray page Figure is dad NN 3 Select ISE and then click i Controls to display the Controls parameters for ISE 0070330 Figure 7 The Controls eee programming automatic or T amp c request follows the identical procedure of Clinical Chemistry Chapter C paragraph 1 4 Controls Selection of a single electrode is required prior to controls programming Use the command Save for memorizing data Cancel for leaving the program without saving chang
151. d for the refrigerated bottles to completely reach steady state Approx 2 hours CLINICAL CHEMISTRY Sampling cycle 11 seconds Analytical throughput 330 tests hour single reagent Test execution time max 360 seconds ISE PROCEDURE ISE Test execution time 70 seconds Sample throughput 51 Samples hour Analytical throughput 204 Results h K Na and 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 Section I Chapter D Performance and Limits BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 5 Optical System oolid 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 0 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 Reflectorized Halogen dichroic lamp 12 VDC 35 Watts Life hours Approximately 2000 hours NOTE For optimal result
152. d fresh diluent solution and re run the sample Chapter E paragraph 1 5 Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 16 VACUUM PUMP SYSTEM SCREEN MESSAGE CAUSES amp REMEDIES 1 When the vacuum level drops below the preset level the message WARNING LOW PRESSURE is displayed and instantly the sampling procedure is interrupted To continue the tests it is important to solve the problem by verifying items under VACUUM PUMP SYSTEM in paragraph 2 1 in this chapter After resolving the problem the analyzer can be restarted and continue testing from where it stopped NOTE The message WARNING LOW PRESSURE may also appear when waste liquid container is full The vacuum pump system WARNING connected to the analyzer automatically transfers waste liquids into the waste container Whenever the waste container is full the level detector activated audio visual alarm alerts the user LOW PRESSURE The audible alarms have two beep frequencies slow rapid When the external waste container is full the vacuum pump system generates slow intermittent beeps The second alarm of rapid intermittent beeps is activated when the waste chamber inside the vacuum pump is full When the first alarm sounds the analyzer will continue to function for about 4 minutes until the internal waste chamber is full then it stops working 2 Operative steps sequence in case of alarm First alarm on
153. d waste liquid spillages Waste products must be handled with extreme caution It is recommended that disposable gloves for the safe handling of the waste in the laboratory must be worn before removing and replacing the peristaltic pump cartridge or servicing the unit and when hands may contact potentially contaminated materials and surfaces or components Carefully discard the used gloves in a proper refuse container 10 The waste chambers inside the pump system should be fully discharged prior to any internal repairs or shipping for service Press RESTART button for approximately 30 seconds to fully discharge the waste chambers inside the pump cabinet Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 8 of 19 c d DANGER TO AVOID ACCIDENTAL CONTAMINATION WITH CHEMICALS PATHOGENS AND MICROBIAL CONTAMINANTS USE SUITABLE GUARDS AND OR PERSONAL PROTECTION WHEN HANDLING CHEMICALS SERUMS REAGENTS ETC THE SAFE DISPOSAL OF THE WASTE MATERIALS IS THE RESPONSIBILITY OF THE USER INSURE THAT THE DISPOSAL OF RINSE WATER IS DONE ACCORDING TO ALL APPLICABLE LAWS AND REGULATIONS ACCIDENTAL INJECTION OR PRICKING OF THE SKIN WITH ANY SHARP OBJECT NEEDLE ETC MAY CAUSE A PROLONGED AND VERY PAINFUL LOCAL ANTIMICROBACTERIAL INFLAMMATORY REACTION EVERY PRECAUTION SHOULD BE TAKEN TO AVOID SUCH ACCIDENTS IMPORTANT NOTICE THE WARNINGS INFORMATION ITSELF IMPLIES MANY NATURAL AND ACCEPTED
154. e 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 multiplied by the factor computed during calibration to obtain the concentration of the analyte in the sample Conc in sample Factor x Reagent Blank A DELAY TIME INCUBATION READING 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
155. e 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 N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 16 z z _ Reset Diagnostic for Mismacsdes Reslocenent dat Kit Tubes and Pernstaltic pomp 01 09 2002 Kit Tubes and Peristaltic pomp Kit Tubes 1 5 module 0120922002 Extra Wash 01706 2002 Kit Tubes 1 5 module I S E Electrodes K C02 0120922002 I E Electrodes K CO2 5 E Electrodes Cl Ret 0 5 2003 Pompe and filter Vacuum System 01 09 2002 5 Electrodes Ret Photometric Lamp 1500 Hours 01 11 2002 Pompe and filter vacuum System Photometric Lamp 1500 Hours i 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 replacement are not indicated for simplification There are three tubing and accessory kits for maintenance A Bimonthly Maintenance Kit for ISE tubing ISE Module tubes DA and should be replaced every two months for error free operation Six Month Maintenance Kit Reading Station ISE Module Vacuum Pump System for special tubes exposed to wear and tear including pump cartridges etc and an annual maintenance kit Reading Station ISE Modu
156. e management of users and the possibility of insertion removal of users Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 19 Manage Users Available Users Mi Level 0 NN l Level 3 DAVID Ge Select all Deselect all Delete List of authorized users with proper access level highlighted Exil Shutdown 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 O it is important to know the corresponding access level password Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 18 of 19 Press New User in the previous screen Manage Users to insert a new user 2 3 4 5 6 User Hame USERT Password min amp chr Soe ee L anfirm Password Access Leve 6 Cancel Access Patient Archive Insert user name may be already present Here it is not possible to use the combination of identical User Name and Password Insert password minimum 8 characters Repeat password in the Confirm field Assign the initial access level to the user to select a level different from 0 the knowledge of corresponding password is necessary Enab
157. e run Figure 23 Figure 24 Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 26 of 32 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 is possible to enter intervals of days and hours for automatic controls run Fig 24 upon Date 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 upon Hour 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
158. e to reagent or sample residues on the external surface of the needle with consequent contamination during preparation Remove Needle s and clean them externally using gauze soaked with alcohol Figure 7 Check the efficiency of built in devices for needle cleaning In case of vacuum pump malfunction refer to items in VACUUM PUMP SYSTEM on the next page in this chapter If the problem with vacuum pump still persists or if there are any obstructions in the cleaning devices contact immediately the nearest Biotecnica sales service office Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 16 SYMPTOMS CORRECTIVE ACTIONS Results are imprecise due to vacuum pump malfunction or occluded washing piston insufficient cleaning or drying in case of vacuum pump malfunction refer to items in of the reading cuvettes VACUUM PUMP SYSTEM below If the problem with vacuum pump still persists or if there are any obstructions in the washing piston contact immediately the nearest Biotecnica sales service office NOTE Check sampling washing hydraulic circuit for leaks which may affect system performance 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
159. eady tuned If not then observe the following procedure 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 Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 10 Figure 6 PRINTER Refer to Figure 6 for connections FLUIDIC CONNECTIONS The external fluidic manifold to the upper right side on the rear Figure 7 has three connectors for intake and discharge of fluids A transparent tube supplies double distilled water from the external container and the black amp blue tubes discharge the analyzer waste through vacuum pump system to the external waste container In addition a transparent tube for fluid overflow is located at a lower level from the fluidic manifold o Figure The transparent black and blue tubes are fitted with quick connects having built in shut off valves which in case of disconnection prevents liquid spillage The transparent tube double distilled H20 plus Surface Active Agent i e tensioactive
160. earlier in this chapter evident reason VACUUM PUMP SYSTEM The vacuum pump is silent a No power to the system Power cord disconnected Connect the power cord ia Restart green LED not b Blown fuse s Replace with appropriate fuses as marked It Audible alarm of intermittent ndicates vacuum level variation due to leakage in the hydraulic frequency some flashing circuit connection s Ensure that the waste tubes blue and black J tubes connecting vacuum pump to the analyzer are firmly LEDs and the instrument in connected standby mode During the analyzer operation this phenomenon may be considered normal as there may be sudden variations in the vacuum level during emptying of the reading cuvettes Audible Alarm of intermittent External waste container full Empty the external waste container and press RESTART button on the vacuum pump cabinet to frequency with the LED on the continue the operating procedure and to reset the alarm waste probe lit Damaged Unit The unit has suffered severe shock such as being dropped Do not use the unit Consult your nearest sales service office regarding repair Smoke strange odor or noise Stop using the unit immediately and disconnect the power supply Consult your dealer regarding repair 2 2 SCREEN MESSAGES 2 2 1 SCREEN MESSAGES CAUSES AND REMEDIES The BT3000 PLUS software has a built in Auto diagnostic function which is enabled during normal working s
161. ecessarily 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 curve 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 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 Chapter Fu
162. eck Sum String Character ANALYSESCODE Analysis Code String ANALYSENAME Analysis name String ANALYSESTYPE Analysis Type String Character ANALYSESCONCENTRATION 1 1st Concentration otring ANALYSESCONCENTRATION2 2nd Concentration otring ANALYSESFLAGS 1 Flag 1st Result String ANALYSESFLAGS2 Flag 2nd Result String ANALYSESMINVALUE Minimum Value otring ANALYSESMAXVALUE Maximum Value String ANALYSESUM1 1st Unit of Measurement String ANALYSESUM2 2nd unit of measurement String 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 F Female Child Identifies Routine or STAT Select one of these Routine 5 STAT Transmitting patient from archive will always have identifier of Routine S Identifies Serum or Urine Select one of these S 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 sa
163. ed by sector or single reagent the analyzer will read the inserted codes Section I Chapter I Barcode and Related Functions BT3000 PLUS 0 Soft Ver 8 Page 4 of 4 OPERATOR MANUAL BT3000 PLUS SECTION I GENERAL INFORMATION CHAPTER K 1 VACUUM PUMP SYSTEM INSTALLATION OPERATION 1 1 System control functions Waste container external Installation amp operation Maintenance and care Trouble shooting Spare parts for maintenance A mA ok eA ok e NO Functional characteristics 2 VACUUM PUMP SYSTEM P N 662 0788 amp BYPRODUCTS OBSOLETE No longer in production Introduction Technical description vacuum pump Principles of operation Vacuum gauge Vacuum level regulator Hydrophobic filter Warnings Technical Specifications Caution Shipping retainer Vacuum pump system Installation Quick start up Care and maintenance Fuse replacement mains power inlet module Filter replacement Peristaltic pump cartridge replacement Trouble shooting guide Cleaning of the hydrophobic filter User serviceable spare parts Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter K Vacuum Pump System Index BT3000 PLUS 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 Rev 0 Soft V
164. elected the list of control positions is displayed Fig 10 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 E E E STAT Control Standard New Entry Options analyses Clear Patient List Figure 10 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 19 Insert Batch In this page Figure 11 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
165. emble the electrodes stack and place it into its housing Position the housing with the measurement electrodes on the ISE panel and gently press fit to the right into the appropriate connecting pins of the detection electronics 8 Carefully fit the housing with Ref amp Ground electrodes by gently pushing to the left into the pins of the detection electronics 9 Reconnect tubes 2 3 4 and 5 10 Secure the metallic shield using the thumbscrews 11 Insert ISE module into its appropriate slot Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 8 of 17 2 ET Electrode 0 Biotecnica Instruments SpA Tube 3 BY N 5 didi E l Tube 4 55 E u p ee al ed 1 5 PRELIMINARY STEPS BEFORE STARTING THE SYSTEM This procedure is necessary when installing the system or after replacing the electrodes For normal operating functions observe the following procedure a Place the working solutions in their respective lodgings Figure 12 b Make sure that the contents of the working solutions are sufficient for the necessary workload Caution This verification of volumes for necessary workload is highly recommended Whenever baseline or buffer solutions are changed a new calibration of the system must be performed which is not possible during the determination of tests c Run Prime I S E refer to C
166. enables or disables vocal function vocal messages 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 Figure 8 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 Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page70f 11 Printer Header Footer Customizes the printouts generated by the analyzer in the Archive Quality Control System Printer Header Foolher BarCode Serial LS E Module Working Temperature Samples Tray Passwords Utilities Figure 9 Two editable fields are displayed for wssese ole s aee programming of HEADER amp HEADER FOOTER Characters can be BIOTECNICA INSTRUMENTS 5 4 formatted B for bold U for underline I for italic as needed Font type size and text color are also available To print a test page click Test button FOOTER Dave Qo Figure 9 Bar Code Enables bar code scanning option Figure 10 Confirm Present to enable it or Not P
167. ence Solution 10 ml 200 tests RESIDUAL VOLUMES OF REAGENTS BOTTLES NEW SERIES 80 ml BOTTLES 1 ml 50 ml BOTTLES 1 ml 20 ml BOTTLES 0 5 ml 10 ml BOTTLES 0 5 ml ISE MODULE Number of electrodes 4 plus Reference Electrode Analytes K Na and CO optional Test processing Time for the ISE 70 seconds Executive throughput 51 Samples h Analytical throughput 204 Results h K Na Reagents Buffer and Reference Solution concentrated Section I Chapter O Technical Specifications BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 6 Sample Type Serum Urine Whole Sample Volume 30 ul Concentrated Reagents Dilution 1 10 with H2O automatically Dilution of Serum Buffer 1 14 automatically Precision on Serum test 1 for 2 for Cl 3 for Precision on Urine test 2 for and CI Linearity for Serum test Na 50 200mEq L 1 20mEq L 50 400mEq L CO2 10 45mEq L Linearity for Urine test 20 400mEq L 2 200mEq L 40 400mEq L Accuracy for Serum test Intra Run Serum 20 samples Na C V lt 196 V lt 2 lt 5 Infra Run Serum N 20 samples V 2 lt 2 5 lt 5 Accuracy for Urine test Intra Run Urine 20 samples and C V lt 2 Infra Run Urine 20 samples and C V lt 2 5 Average Life of Electrodes and Reference Electrode 12
168. er 8 oh B BRO W DN 1 VACUUM PUMP SYSTEM INSTALLATION OPERATION 1 1 FUNCTIONAL CHARACTERISTICS Vacuum Pump System Always check and empty Analyzer the full waste container Analyzer Blue Tube and press Restart button Black Tube Restart C To Analyzer Waste Probe C Normal Pressure AN WARNING gt Low Pressure 1 Read vacuum pump system instruction and warning notices carefully 2 Disposable gloves must be worn when servicing the vacuum pump system where hands may contact potentially contaminated waste materials C Low Pressure Alarm Figure 1 Vacuum Pump System P N 06 05161 01 for BT3000 PLUS amp BY PRODUCTS This silent and compact vacuum pump system has been specifically designed for use with BT3000 PLUS type analyzers It provides for an automatic and safe collection of waste liquids from analyzer s reaction cuvettes and sampling needle washing into the external waste disposal container in lab environment The system consists of a metallic cabinet containing two membrane pumps controlled by a microprocessor electronics and the electrical and fluidic connections to the analyzer The microprocessor manages three main functions pressure measurement waste container full check and pump shutdown The waste discharge has the following pathway course A The liquids aspirated by the pumps from the needle washing funnels bowls and the cuvet
169. er 6 Technical Assistance BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 2 OPERATOR MANUAL BT3000 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 II Chapter 7 Bibliographical Reference Index BT3000 PLUS Rev 0 Soft Ver 8 BIBLIOGRAPHY 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 medical devices 1998 EN 980 1996 Graphical symbols for use in the labelling of medical devices Section II Chapter 7 Bibliographical Reference BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 2 OPERATOR MANUA
170. er E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 19 allows tests 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 Exit To leave program press Exit New Entry Routine After the selection of Routine followed by confirmation through command New Entry the patients acquisition frame is displayed Figure 7 The programmed patient can be executed immediately or saved for later use The programming fields and the functions are outlined below Duplicate Patient Urine Duplicate patient Draw Date External dilution factor 06703702 E 00 Note Position pa un A Test Profile E Delete Save Figure 7A Figure 7 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 Urin
171. er a Kinetic or a Fixed Time then e ABS ABS Dynamic Blank Value If 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 ccu 280 TL D Y LyY TY where Number of readings Number of reading i Times Readings 5 Linear Regression Section Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S 7 of 32 where Ll 7 50 8 Angular coefficient for the line Final point for the line Number of readings Number of reading i Times Readings Distance point line where lt D Y MX Q Angular coefficient for the line Final point for the line Point Abscissa Point Ordinate Distance between two points where X Y Xo X4 yo y X x Y 2 y y yi Xx Abscissa Ordinate First Point Abscissa Second Point Abscissa First Point Ordinate second Point Ordinate Mathematical Functions for Clinical Chemistry VOLUMETRIC FACTOR USED IN SAMPLE BLANK A TESTS where vS vR vR Section I 0 YS vR vS VR vR
172. ering Information BT3000 PLUS Rev 0 Soft Ver 8 SIZE 2x50 ml 1 liter 1 Se Ll Ll LI Ll Refer to Section I Chapter K Vacuum Pump System 1 Refer to Section I Chapter K Vacuum Pump System 1 min 1000 Page 3 of 4 3 3 ISE MODULE CONSUMABLES PRODUCT PART NO SIZE 5 Low Calibrator 943 2x20 ml S E High Calibrator 944 2x20 ml 5 Starter Kit ZBT3000 PLUS 600 Tests 947 1 Consists of 943 944 947A 947B 947C 947D S E Buffer BT3000 Plus concentrated 947A 3x10 ml S E Reference BT3000 Plus concentrated 947B 3x10 ml S E Washing Solution 947C 3x10 ml S E Enzymatic Solution 947D 3x10 ml By Pass Electrode 662 0709 1 Reference Electrode 662 0710 1 Sodium Electrode Na 662 0711 1 Potassium Electrode K 662 0712 1 Chloride Electrode Cl 662 0713 1 CO Electrode 662 0716 1 Cleaning tool for Chloride Electrode 03254 1 Section II Chapter 3 Ordering Information BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 4 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 4 4 Software 4 1 Serial Communication BT3000 PLUS Host Computer Pages 4 4 2 Variable communication protocol Page 6 4 2 1 Serial communication test programs Page 17 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 4 Serial Communication Index BT3000 PLUS Rev 0 Soft Ver 8 4 SOFTWARE 4 1 SERIAL COMMUNICATION BT3000 PLUS
173. es and Print for hard copy printout Figure 8 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 17 The displayed page is divided into two parts one for the Known controls and the other for the Unknown controls Figure 8 The opening page is default set to Level 1 controls To set parameters for Level 2 and 3 click corresponding tabs KNOWN CONTROLS Known Controls Select the electrode prior to entering the control s Naf a range values Lot Name Enter a name or a lot number Sample position Enter the sample s physical position on the plate The reserved sample positions are located in the inner circles of the sample plate and are dedicated to calibrators and controls The numerical positions on the sample plate correspond to those established in the Setup Analyzer refer to Chapter H paragraph 2 Setup Analyzer Low value Enter the lower value for the control s range Theoretical Value Enter the theoretical value for the control High value Enter the higher value for the control s range Insert re run timing 297 Timed re run This parameter allows programming of automatic a Time interval ti f trol It i Stee ie inate execution of controls is y c E 30 possible to insert automatic Upon execution time for each single control Check Timed re run box and then Click Timed re run just above the View used
174. es 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 must be specified Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 19 With this type of acquisition the controls belonging to the stored will use the positions assigned to routine patients not the dedicated ones Position 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 op
175. es 1 5 module 01 03 03 Extra Wash 01 12 02 Kit Tubes 1 5 module I S E Electrodes K C02 01 03 03 L S E Electrodes K C02 S E Electrodes Na Ref 01 11 03 Pumps and filter Vacuum System 01 03 03 1 5 Electrodes Na CI Ref Photometric Lamp 1500 Hours 01 05 03 Pumps and filter Vacuum System Photometric Lamp 1500 Hours Clear Diagnostic for ptical transmission 100 Es Figure 6 1000 Show Optical Transmission After each photometric zeroing it indicates the percentage transparency of the DT cuvettes The cuvettes with poor transparency are highlighted 100 Figure 5 Show Diagnostic it shows the status of the various parts of the system that should be replaced regularly This page shows the consumable parts life cycles remaining cycles and the replacement date Figure 6 When at the analyzer start the message There are the 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 fo
176. ess ENTER to use the default partition Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 23 Select Format the partition using the FAT file system n r TE 01 m 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 PE s Lu EA RTI eue Vx ELE 37 5 02 SUB WC jys y 3 EE h 4 H E P I t Page 4 of 23 Rev 0 Soft Ver 8 BT3000 PLUS Software Installation amp Upgrade Chapter 5 Section II 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 ra pet pr t wu a 3 i ere At the end of preceding phase the system will restart DO NOT REMOVE C
177. essions 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 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 N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 11 of 16 SCREEN MESSAGE CAUSES amp REMEDIES The error SAMPLE IS MISSING is displayed when the SAMPLE IS MISSING analyzer detects the absence of sample through a built in liquid sensor It is subdivided into NO ROUTINE NO NO ROUTINE XX STAT NO STANDARD NO CONTROL After this NO STAT XX message the sampling of the missing sample is NO STANDARD XX interrupted It is possible to run missing tests using the NO CONTROL XX rerun commands Chapter E paragraph 1 5 The error REAGENT IS MISSING is displayed when REAGENT IS MISSING the analyzer detects through a built in liquid sensor the absence of reagent needed for test run After this NO REAGENT XXX message the sampling of the missing reagent is
178. etected 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 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 D flag Hyperactive Sample out of Max ABS Delta 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 Note The parameters Test limit Initial ABS Fin
179. 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 Line for two points 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 bichromati
180. fer Baseline Considerable increase of potentials up to 100mV decrement of slopes b Insertion of identical reagents Buffer Buffer or Baseline Baseline The potentials are almost within norms but there is considerable decrement of slopes In the above items a and b the Baseline values shown in the preceding example shall not be coherent Obstructions caused by proteins in electrodes amp CO After approximately 150 to 200 samples the Cl amp electrodes may be periodically obstructed In this case one observes an increase in the slopes of K amp Na and decrement in the slopes of Cl amp CO Follow the instructions for the cleaning of electrodes A similar error may also be caused by a partially occluded Ground electrode Generally the obstructions are caused by the foreign matter and not by protein Carefully observe the cleaning procedures as outlined in the Figures 13 and 14 on the ensuing pages NOTE A prolonged obstruction of the Cl electrode may progressively obstruct the electrodes below it and Bypass For cleaning these electrodes use syringe for the and the cleaning tool on the Bypass as shown in the Figure 14 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver Page 14 of 17 b BAD RESULTS OF SAMPLES Generally this phenomenon occurs during sampling but it may take place afterwards Observe the above mentioned diagnostic procedures C ERROR MESSAGES AIR BUBBLES
181. g patients Program Code Access level 1 Normal User Q D Main menu Each menu generates additional commands and or options amp Direct access icons Selecting any icon the corresponding command is directly activated Software version Operating program version Access level It is the password dependent access level allowed to the operator Message bar Clicking here opens a window showing messages received by the program 7 Errors bar Clicking here opens a window showing the errors that occurred during the work session Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 19 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 To 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 comple
182. g Profiles Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page amp of 1l Serial Enables RS232 serial System Printer Header Footer BarCode Serial 1 5 Module Working Temperature Samples Tray Passw al gt 7 port to communicate with host computer Figure 11 Check Present to enable or Not Present Parameters COM Number 1 C Not Present Baud Rate Present to disable Once the m I serial port is enabled the Hardware Sotware i Internal Parameters functions with the QI fields Number Baud E TE VeRO Sn Rate and Hand Shake are Sendthe results with instead of the value enabled too O 9 9 7 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 and the host computer 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 7 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
183. g 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 The 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 Cuvettes position The sampling arm moves over cuvettes tray The sampling needle must be centered on the cuvette ISE ARM Washing position ISE Same as clinical chemistry sampling arm Arm on 1 ring ISE Same as clinical chemistry sampling arm Arm on 2 ring ISE Same as clinical chemistry sampling arm Arm on 3 ring ISE Same as clinical chemistry sampling arm Arm on 4 ring ISE Same as clinical chemistry sampling arm Arm on Funnel ISE The sampling arm moves on to the ISE funnel where it must be centered Arm on enzyme solution ISE The sampling arm moves on to the appropriate hole corresponding to the enzyme solution in the instrument s top Arm on washing solution ISE Same as above but for the washing sol
184. g 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 Patients Archive Code 0006209 Male Test Date 03 03 03 Surname Barnard Name Paolo Notes Questa una nota abbastanza lunga Analysis Method Result Result 2nd Range Range 2nd islucasia Trinder j 90 33 mg dl 22 00 53 00 RAT Trinder 75 90 mgidl s4 00 114 0 Colesterolo Color BO 63 mg dl 40 00 118 0 FAC MA 27 02 mud 10 00 34 00 Bilirubina Jundrassik m 94 58 35 00 89 00 Glicemia Trinder C 11 07 mall 37 00 101 5 VED MA 83 44 mgidl 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 Ulidl 47 00 126 5 Bilirubina XXX 16 16 Ul dl 43 00 109 5 Lipasi Jundrassik 55 45 Ulidl 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 XXX 19 74 UM 40 00 91 00 Bilirubina XXX C 42 18 117 52 00 121 0 FAC Color 43 46 Ul dl 51 00 107 5
185. ge Page Page Section Chapter E Operating Procedure Index BT3000 PLUS 0 Soft Ver 8 ili 12 16 16 1 OPERATING PROCEDURE 1 1 TURNING ON PROCEDURE Turn on the analyzer by pressing on off switch on the rear panel refer to Chapter 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 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 View volumes status special reagents Reagents status Washing solution C rm ca 10 0 lt Number of samples Figure 1 Figure 2 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 p
186. ge 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 Unit 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 of Limit Interference Hyperactive Sample Test Limit Unstable Serum Hyperactive Sample Max Abs Limit Inverted Reaction Hyperactive Sample Max Abs Delta No Reference Solution PL 1008 Li Pathological Sample above Maximum Bubbles in ISE Module Value above the Standardization Curve Related Analysis Calculation Impossible Value below the Standardization Curve Error in calculating Related Analysiz 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 Af New Value E Accent 8 Cance Figure 29 Modify Analysis Value It is possible to modify the selected analysis Fig 29 result by right clicking with mouse in the I
187. gle 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 to deselect it but 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 Section IT CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 14 of 19 1 6 DISPLAYING AND PRINTING RESULTS Displaying Patients 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 P H7 CTRL9413 Lanti David Control Unknow Level 2 Lipasi lt Trinder gt 8 68 i 8 47 l licemia zLolor 94 9 moz dl i es Fac lt Trinder gt 33 9 UIrdl i 3 60 ow VED ZAA 43 2 ug dl i 5 18 RAT Colors 69 0 UIrdl i 4 20 Bilirubina XXX 24 4 HI dl i 5 08 PRY lt Color gt 12 7 HI dl i 1 56 BID XXX 35 0 i 0 890 Glucosia ae 39 9
188. grips 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 TO BT 3000 PLUS y Q Figure 2 UPS Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 10 Vacuum pump and printer should be connected to the appropriate accessory power connectors on the analyzer rear panel adjacent to mains power inlet See Figure 3 FUSE PRINTER POWER ON OFF ANALYZER E J Ea 9 VACUU PUMP POWER 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 alr
189. h query It is ZEE 5 8 7 8 possible to select the initial and final date with simple clicks 5 rv e B a ai inthe window shown at the left Click on exit to save and close the frame Press ESC to abort Figure 24 Section I Chapter F Q C Population Patient s Archive BT3000 PLUS 0 Soft Ver 8 Page 18 of 23 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 PES search is case sensitive meaning that the system distinguishes the capital letters Upper case letters from the E a small letters lower case letters Or Ooms 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 Codes Selection Insert Initial Code Name Surname Selection click on the hand icon Select Name 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 S search or click Cancel to abort the operation Figure 26 3 2 PATIENTS REPORT View Analyses In this page Figure 27 it
190. h the following setups 9600 1 None Hardware Important Notice These two programs are in the installation disk under Utility folder Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 18 of 18 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION 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 BT3000 PLUS Program 5 6 Upgrading the BT3000 PLUS software Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page Page Page Page Page Page Page 1 of 23 5 INSTALLATION OF THE OPERATING SYSTEM OS CAUTION INSTALLATION OF THE OPERATING SYSTEM MUST BE DONE BY EXPERT PERSONNEL AND TECHNICAL PERSONNEL ONLY 5 1 PRELIMINARY PHASE 1 Ensure that the BIOS has the following Boot configuration Hard Disk CD ROM Drive A 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 ENTER Continue 1 F3 Quit Press enter to init
191. h 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 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 5 L R1 R1 Only Read Sige HR SL End Point Fixed Time Kinetic I R Double R1 Ta R2 Tb R1 5 Ta R2 Tb gt L End Point Fixed Time Kinetic I R Double R1 R2 Tb R1 R2 S Tb gt L Sample Blank A R1 5 1 R2 Tb L2 Sample Blank BERRE Sample Blank L2 L1 Sample Blank B Double R2 R1 5 L1 R2 5 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 ec ni ein 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 bla
192. hapter H paragraph 1 1 1 and repeat it for at least three times Working Solutions Figure 12 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver 8 Page9 of 17 If one or more electrodes or any other component has been replaced then it will be necessary to perform additional calibrations for reconditioning d Verify that programmed values for the standards high level low level correspond to the used lot Programming is performed as shown in Figure 7 where the values for two standards must be entered for the calculation of slope during the calibration e To reduce the risk of contamination of baseline and buffer solutions through ambient air it is suggested to remove and close the two bottles at the end of daily working sessions Remember to open and replace these bottles at the beginning of every new working session The ISE module should be considered by the user as an ordinary test for Clinical Chemistry requiring a programming of its own for standards and controls Calibration should be performed every four hours and it is essential for precise and accurate results In addition it is recommended to execute repeated calibrations until a stable slope value is obtained 1 6 CALIBRATION PROCEDURE Standards are automatically diluted with buffer solution pH 8 6 with a ratio of 1 14 The mixed product is aspirated into the electrodes through the peristaltic pump After an incubation period the reading i
193. haracter otring otring otring Character otring Character otring Character otring Character otring Character otring Character otring Character otring Rev 0 Soft Ver 8 Page 12 of 18 Identifies a Control or a Sample Select only one of these CONTROL Sample Control Sample Control Sample Control Sample Control Sample Control Sample Control Identifies a Known or Unknown Control Select only one of these UNKNOW KNOW Unknown Known Unknown Known Unknown Known Unknown Known Unknown Known Unknown Known Identifies Control Level Select only one of these LOW NORMAL ABNORMAL Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 0 Identifies if it is a Clone Select only one of these 0 1 0 NI NOCLONE CLONE Section II Normal Clone Normal Clone Normal Clone Normal Clone Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 18 TABEL 2 INTERNAL VARIABLES Variables Decima Hexadecimal Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 14 of 18 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 ZPat
194. 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 selection 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 19 In patients bar code printing protocols it is possible to add P
195. he ISE system with the appropriate Daily Before turning off solutions 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 BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 10 OPERATOR MANUAL BT 3000 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 mathematical 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 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section Chapter C Functions Analyses Prog Ctrls Calib Index BT3000 PLUS 0 Soft Ver 8 1 FUNCTIONS 1 1 DESCRIPTION OF THE PROGRAM MENU As already described in the Chapter A the BT3000 PLUS is a clinical chemistry automated analyzer for programming and performing tests in Routine programming per patient Batch samples per test and STATs on seru
196. he needle tool into either end of electrode Keeping your fingers off the opposite end of electrode slowly but firmly push the needle straight through the electrode s inner core until the needle tip appears at the other end of the electrode be careful not to bend the needle inside the electrode Wipe off any debris on the needle tip and gently pull the needle back out of the electrode Wipe off the needle and remove any debris or moisture from the electrode surface CHLORIDE ELECTRODE NEEDLE TOOL 2 Reinstall the electrode into the electrode housing in the correct order 3 Install the electrode housing into the ISELyte Analyzer Connect tubing and prime the ISE module completely If the electrode s performance does not improve contact your local Technical Support WARNING NEEDLE TOOL can damage all other electrodes K Na CO2 REF Do not use Chloride Electrode Cleaning Procedure Figure 13 Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver Page 16 of 17 FOR CONVENIENCE SAKE IT IS IMPORTANT TO DETACH THESE ELECTRODES IN SMALL GROUPS FROM THE REST TO AVOID POSSIBLE ACCIDENTAL DAMAGE WHEN HANDLING A LONG STRING OF ELECTRODES OBSERVE THE CLEANING PROCEDURE OUTLINED HERE FOR OTHER ELECTRODES GND Electrode REF Reference Electrode BI DISTIL
197. his 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 The analyzer at about the expiry of a month prompts this operation Place a bottle containing sodium hypochlorite solution at 5 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 your 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 th
198. iate installation Section IT Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 23 Now the screen displays the end user license agreement for Microsoft Windows PORTANT READ CAR icense Agreement legal between you Ceither an individual 0 n eee 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 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 EYEE 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 Pr
199. ic pump cartridge and filter changes The theoretical operating life of the pumps is between 4000 to 5000 hours after that the service technician should substitute the pumps WARNING a DISPOSABLE GLOVES MUST BE WORN WHEN SERVICING THE VACUUM PUMP SYSTEM WHERE HANDS MAY CONTACT POTENTIALLY CONTAMINATED WASTE MATERIALS 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 1 6 TROUBLE SHOOTING TROUBLE SHOOTING GUIDE The vacuum pump is silent and a No power to the system Power cord disconnected Restart green LED not lit Connect the power cord b Blown fuse s Replace with appropriate fuses as marked Audible alarm of intermittent frequency Indicates vacuum level variation due to leakage in the some flashing LEDs and the instrument hydraulic circuit connection s Ensure that the waste tubes in standby mode blue and black tubes connecting vacuum pump to the analyzer are firmly connected During the analyzer operation this phenomenon may be considered normal as there may be sudden variations in the vacuum level during emptying of the reading cuvettes Audible Alarm of intermittent frequency External waste container full Empty the external waste with the LED on the waste probe lit container and press RESTART button on the vacuum pump cabinet to continue the operating procedure and to reset the alarm
200. ica 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 Conditions Page 4 of 4 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 3 3 ORDERING INFORMATION 3 1 GENERAL TERMS AND CONDITIONS FOR SALE 3 2 Consumables for BT3000 PLUS 3 3 ISE Module Consumables Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section II Chapter 3 Ordering Information Index BT3000 PLUS Page Page Page Page Rev 0 Soft Ver 8 I 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 paragraphs 3 2 and 3 3 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 Q
201. ientListType Char PatientType Char PatientClone Stringn PatientCupPosition 2 Stringn PatientNumberTest 2 Set BeginAnalysesData Stringn AnalysesCode 4 Set EndAnalysesData Stringn CheckSum 3 The following are the details 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 AnalysesCode 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 PatientNumberTest Set EndAnalysesData End of analysis codes Stringn CheckSum 3 Check Sum transferred as a string of fixed length equal to 3 characters Section IT Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 15 of 18 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 ZPatientNumberTest 3
202. ile 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 send 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
203. ime 2 minutes terminates without resetting the system pumps disabled In this case the green LED of the Restart button flashes in quick successions 1 3 WASTE CONTAINER EXTERNAL The waste probe is placed into the external waste container to transfer liquid ejected from the waste pumps into the container For safety reasons the waste probe is equipped with a liquid level sensor which is activated when the external waste container is full In this condition the liquid level sensor transmits the signal to the microprocessor thus putting the system in standby mode In addition the vacuum pump system generates an intermittent audible alarm and the red LED on top of the waste probe is lit During the standby lasting approximately 2 minutes the waste fluid flow is deviated through a three way solenoid valve into the internal waste chamber thus continuing the waste aspiration function transitorily but the fluid flow to the external waste container is stopped The purpose of this momentary deviation is to avoid any spillage during the transfer of the waste probe from one waste container to another empty container After emptying or substituting the external waste container press Restart button on the vacuum pump system front panel to continue the operating procedure and reset the alarm If the preceding step is not taken after 2 minutes the system will enter the alarm condition by turning off the aspiration pumps of the vacuum pump system Simul
204. ine CRE x urine ml 24 h serum CRE x 1440 the formula would be CRE amp U 900 ERE amp S 1440 The button Test Function Fig 10 b 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 present 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 clic
205. ing 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 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 19 The single password sequences except for the Administrator will expire every three months and wil 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 fo
206. io 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 e Name enter the complete name e Urine pl sample volume expressed in ul 100 ul max e 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 Primary parameters Check Parameters Secondary parameters Pade Sample Starter Saye 01 Delay Time Print Test methodology Uu Reading Time Method End Point 4 Reagents E n Kind of process ae ncubation time with Factor E Sample Ti ime 1st Filter 2nd Filter s mo s Times p Reagent 1 r Reaction direction Increasing C Decreasing Te Copy From Figure 19 e Sam
207. iquid is required to be automatic removal of waste The gauge controlled suction can reach a maximum vacuum of 400 mbar It produces low noise level while maintaining strong suction capabilities It provides for an automatic and safe collection of waste liquids from to the external waste disposal containers in laboratory Whenever the external waist container is full the waste probe liquid level sensor activates a low frequency audio visual alarm and instantly shuts down the peristaltic pump The vacuum pump stops running if any of the internal waste collection chamber is full and remains in the standby mode until the waste containers are emptied and the alarm reset The suction unit cabinet accommodates two inner waste collection chambers of approximately 300ml capacity each The vacuum to the waste chambers is aspiration of waste liquids from analyzer is provided by the vacuum pump The waste liquid aspirated from the analyzer is collected in these waste chambers Simultaneously two high throughput peristaltic pumps are used to transfer the waste liquid to the external waste containers through external waste probes thus preventing secondary contaminant exposure The peristaltic pump features a removable and disposable cartridge that is pre loaded with special Pharmed tube Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 19 2 2 TECHNICAL DESCRIPTION VACUUM PUMP The waste suction unit utilizes a vacuum pump fo
208. 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 Lamp Setup This function performs a partial FCC procedure i e a specific zeroing of the photometer which is necessary every time the lamp is replaced It is advisable that only technical assistance personnel use this function 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
209. is possible to view the test results of a selected code Results for 04 03 2003 Code 0001431 Sumame Hame Date Group Rossi Roberta 04 03 2003 Male Notes Questa amp una nata abbastanza lunga b Fac Coor myd 3539 Lp Cow myd 738 RAT Tide BR VED Tide modi Coo 388 PRY Jundassk 1 BD mod 1371 A Send Prnt Preview amp Previous 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 Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 19 of 23 View Flags This option is accessed through the pa
210. ite at www biotecnica ii Section II Chapter 3 Ordering Information BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 4 3 2 CONSUMABLES FOR BT3000 PLUS PRODUCT PART NO Surfactant Wash Concentrate 392 Cuvettes washing solution 393 Fuse 0 5AT 250 Volt for Vac Pump P N 06 05161 01 330 6338 Fuse 2AT 250 Volt for Vac Pump P N 662 0788 C D E F 330 6340 Fuse 8AT 250 Volt for Analyzer 330 6342B Power Cord for analyzer 330 6391 Power Cord for peripheral devices 330 6400 Peristaltic Pump Cartridge 330 9072 Halogen Lamp 12V 35W for Photometer 330 9321 Tubular Filter for H2O container 330 9614 Distilled Water container 5 It Cubitainer 660 4002 Cleaning Tool for Arm Needle 662 0629A Hydrophobic Filter Assy for vac Pump P N 662 0788 C D E F 662 0807 Waste Container 10 It Cubitainer 662 1010 Sampling Needle 662 1011 Bimonthly Maintenance Kit for ISE Module 662 1016 oix Monthly Maintenance Kit tubing etc 11 05219 01 for analyzers with vacuum pump P N 06 05161 01 02 03 oix Monthly Maintenance Kit tubing etc 662 1002 for analyzers with vacuum pump P N 662 0788 C D E F Annual Maintenance Kit Tubing etc 11 05220 01 for analyzers with vacuum pump P N 06 05161 01 02 03 Annual Maintenance Kit tubing etc 662 1009 for analyzers with vacuum pump P N 662 0788 C D E F Serum Capsule 2 ml 667 1040 Reagent Bottle 80 ml 667 1072 Reagent Bottle 50 ml 667 1073 Reagent Bottle 20 ml 667 1074 Reagent Bottle 10 ml 667 1076 Section II Chapter 3 Ord
211. k on the corresponding tags Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 18 of 32 Primary Parameters Parameters for Clinical Chemistry GLU Primary parameters Check Parameters Secondary parameters Code atu Bar Code Test methodology Trinder Method End Point M Volume pl 300 Concentrated E Number of reagents d Reagents p ue of process W Sample gt Linear T 1st Filter 2nd Filter 510 700 Reaction direction 6 Dilution with water Dilution with sali ore 00 Increasing C Decreasing EN Copy From AR eagent 1 g Save Print 9 Cancel Figure 11 Code The code of the selected analysis is shown in the text box It is not possible to write in this field Bar Code t assign positive barcode identification lt enables if activated in the Setup Analyzer bar code scanning to correctly identify the bottle during reagent s insertion phase is possible to a numerical code for Test methodology In this field the reaction principle used for the test can be specified for example Jaffe 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 Method This parameter defines the main methodology for the analysis To
212. le Vacuum Pump System 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 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 Section I Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 16 Washer tube 3 Remove and discard the old tubing It is possible that a
213. le or not Access Patient Archive Click Accept Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 19 of 19 OPERATOR MANUAL BT3000 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 1 3 1 Westgard Graph 1 3 2 Daily Chart 1 4 Additional Functions 2 POPULATION 2 1 Analysis Selection How to run a Query 2 2 Principal statistics formulas used in Population module 2 3 Diagrams 2 4 Inserting external analyses 2 5 Other menu functions 3 PATIENTS ARCHIVE 3 1 Selection How to run a Query 3 2 Patient s report 3 3 Printing Reports 3 4 Other menu functions Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Page Section Chapter F Population Patient s Archive Index BT3000 PLUS 0 Soft Ver 8 ee ee ee 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 INSERTIN
214. leaved 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 and Related Functions BT3000 PLUS 0 Soft Ver amp Page 3 of 4 2 2 BARCODE ON REAGENTS The analyzer has the possibility to work either as closed system or open system The closed system means the exclusive use of reagents with s
215. logen 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 light 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 malfuncti
216. lots General Parameters Graph Parameters Analyses Level Axe X Level Axe Y BIC type 1 C 1 n nown C 2 2 Unknown C 3 Method Start Date End Date TRINDER 14 12 2001 14 12 2001 Value Axe x 20 0 14 12 2001 Value Axe Y 4 60 14 12 2001 Figure 4 By clicking over a value plotted on the graph the information relating the pair of values will be displayed Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 4 of 23 1 3 1 WESTGARD GRAPH The Westgard graph provides a global vision of a given lot by plotting data on a diagram having the origin at 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 Analyses BIC Lot_ Method TRINDER Type Known Level lt Daily gt Control Level _ rt Figure 5 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 E Analyses Date Time BIC H4nz 2000 faz Method TRINDER
217. m 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 amp drug abuse reading of potassium sodium and chloride carbon dioxide upon request with indirect ISE method lon Selective Electrodes see Chapter L 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 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 cons 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 acces
218. me values of the 1st result Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 11 of 18 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 PATIENTISCONTROL PATIENTCONTROLKNOK PATIENTCONTROLLEVEL PATIENTCLONE PATIENTCUPPOSITION PATIENTNUMBERTEST CHECKSUM ANALYSESCODE Patient Code Patient Name Patient Surname List Group 2 Method Type v Urine in 24 h Descriptive Note If the patient is a control If itis a known control Control Level If itis 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 i STAT R Routine 9 STAT ROUTINE Routine STAT STAT 2 Identifies Male Female or Child Select only one of these 0 Male 1 Female 2 Child 0 Male N Female 2 Child M Male F Female C Child MAN Male FEMALE Female CHILD Child Identifies Serum or Urine Select only one of these 0 SERUM 1 URINE 0 SERUM T URINE 9 SERUM U URINE SERUM SERUM URINE URINE Section II Chapter 4 Serial Communication BT3000 PLUS otring otring otring otring Character otring Character otring C
219. mediate 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 driven 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
220. method Result Date 06 02 2002 Group Test Type Female Serum amp Accept Exil Figure 21 It is possible to store in the analyzer s memory results of other analyses not performed by the analyzer These data will be saved into the archive and it will be possible to display statistics as well as analyses results The input screen Fig 21 shows the following fields Analysis Name Analytical Method Result Date Group and Test Type 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 Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 15 of 23 2 5 OTHER MENU FUNCTIONS The main menu contains two additional sub menus with the following options Backup Restore Backup E xit File Utility Hew Record Delete Hecord s selected Delete Analysis Data Delete Archive Format Floppy FILE Backup creates a backup of the archive in a floppy disk Restore Backup restores the archive backup from a floppy disk Exi
221. minutes before operating phases begin and to allow for equilibrium with ambient temperature and with the carbon dioxide CO level in the air If the thermal equilibrium is not reached then the phenomena of drift effects and erroneous results can occur while a lack of equilibrium with CO may provide higher results for the latter test NOTE If slopes and potentials are constantly out of range this indicates that the electrodes are exhausted or there is an aspiration error of the reference baseline solution in the reference electrode or the working solutions buffer baseline STD are contaminated or degraded In case of contamination or degradation replace in sequence the buffer solution then the reference solution and at last the standard Whenever a product is replaced repeat the calibration procedure In the other cases such as exhausted electrodes or a baseline aspiration error in the reference electrode refer to the Troubleshooting guide 1 7 MEASURING UNKNOWN SAMPLES After a correct calibration the samples are determined which are prepared and read in similar manner to standards dilution 1 14 aspiration into the electrodes potential reading and the reference baseline aspiration The samples are calculated applying Nernst equation E Ey s log Cx C Std Considering the fact that the system requires a calibration the measurement method is defined as comparative ISE tests are programmed in the same way as a
222. mory 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 Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver S Page 29 of 32 Standard parameters for IGA d E To use fu nction of Re calibration an single point standards pre dilution observe the following 4f Automatic dilution 2 E Dilution proced
223. mple of eventual response to the data sent in Sending a patient to BT3000 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 PEE 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 SEQ 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 II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 18 Wiring Diagram of Interface Cable co m g amp M rz BT3000 PLUS Figure 1 1 2 3 a 5 6 7 o m N amp umm BT3000 PLUS BRI Figure 2 Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 18 4 2 VARIABLE COMMUNICATION PRO
224. n 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 BT3000 PLUS Rev 0 Soft Ver 8 Page 8 of 11 4 BRIEF DESCRIPTION OF THE SYSTEM 4 1 FRONT VIEW OF THE ANALYZER Figure 2 1 ON OFF BUTTON FOR COMPUTER 2 LCD DISPLAY 3 REFRIGERATED REAGENT COMPARTMENT 4 SAMPLES TRAY o SAMPLING ARM FOR CLINICAL CHEMISTRY 6 SAMPLING ARM ISE 7 SE MODULE 8 FLUIDIC CIRCUIT AND READING STATION 9 PUSH PULL HANDGRIPS 10 ISE FUNNEL 11 DILUENT BOTTLE Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 11 4 2 REAR PANEL CONTROLS AND CONNECTORS TO HOST COMPUTER EXTERNAL MONITOR PS2 MOUSE PORT LPT 1 COM 3 MAINS POWER PRINTER SERIAL PORT ACCESSORY POWER CONNECTORS aag N MAX LOAD 100 WATTS Q TOTAL LOAD 3 OUTPUTS LINE FUSES 300 WATTS 250 VOLT 8 AT Midi Sound USB2 coy TO UPS an SERVICE CONNECTOR Rm PANEL OUTPUT 1 RX KEYBOARD PORT Mic Sound Line in Sound Line 2 EU LAMP FAN lt BLUE TUBE WASTE 1 NEEDLE WASH BLACK TUBE WASTE 2 READING CUVETTES REAGENTS SAMPLE
225. n 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 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 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 Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 18 of 19 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
226. nctions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S 5 of 32 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 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 Fnr 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 Section Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 6 of 32 Dynamic Blank Check If Dynamic Blank is present and test is eith
227. ndow 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 refrigeration operating error generated by the system 0o BEND o Refrigerator enabled Refrigerator disabled Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 5 of 19 2 Direct Access Icon Enzyme solution Washing solution 3 E2 1 ips re Ir ire kow el Check volumes Number of samples um Scan all battles eM Figure 3 Figure 3A 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 accommodate
228. nfo 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 xit 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 Next goes to the previous next patient Exit exits from the patient s report Print Preview Section Chapter F Population Patient s Archive BT3000 PLUS _ Rev 0 Soft Ver 8 Page 20 of 23 3 3 PRINTING REPORTS The following options are available in the main search window Patient Archives Fig 23 2 Search E Pint al Eu 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 Heport Lipasi BID Bilirubina Colesterolo FAC 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
229. ng 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 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 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 14 of Calibrator Positions Current Tray Standards This list is in a read only format A double click on an active position displays the
230. nk 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 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 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 14 of 32 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 A b 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 dete
231. ntenance 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 M Warnings and Precautions BT3000 PLUS Rev 0 Soft Ver 8 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 SOLUT
232. nts 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 Max U Min Max D 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 Panic 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 avail
233. ny other analysis of clinical chemistry Precision and accuracy errors when determining samples of errors during samples determination please follow indications outlined in the Troubleshooting guide Determined results can be associated to a flag that indicates eventual problems occurred during measurement The presence of D flag near a result relevant to one or more electrodes indicates drift during sample reading i e the drift has exceeded 2mV and thus the electrode may be unstable The flag L near the results indicates the absence of reference baseline solution The flag B adjacent to results indicates the presence of air bubble in the hydraulic circuit during the transfer of the sample into the electrodes The sign in place of the results indicates abnormal values for example 9999999 999 This situation may be result from an interruption of the liquid flow into the electrodes during the test reading phases Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S Page 11 of 17 1 8 PRECAUTIONS FOR ISE MODULE USAGE The ambient conditions play an important role in the correct use of the ISE module Room temperature must be between 20 C and 26 C and the humidity between 35 and 75 If the room temperature varies even by 2 C or 3 C during a working day then it will be necessary to repeat the calibration of the ISE module just before running tests to avoid errors during next
234. o not ever leave the Waste Probe on the floor or outside its external Waste Container OPERATOR MANUAL BT3000 PLUS SECTION I GENERAL INFORMATION CHAPTER L 1 ISE MODULE 1 1 Introduction 1 2 Parameters 1 3 Programming Standards and Controls 1 4 Replacing and Installing Electrodes 1 5 Preliminary steps before starting the system 1 6 Calibration procedure 1 7 Measuring unknown samples 1 8 Precautions for ISE Module usage 1 9 Suggestions for performance maintenance 1 10 Troubleshooting Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter L ISE Module Index BT3000 PLUS Rev 0 Soft Ver 8 Page Page Page Page Page Page Page Page Page Page 1 ISE MODULE 1 1 INTRODUCTION In addition to the Clinical Chemistry and Immune chemistry tests the BT3000 PLUS analyzer allows tests for the Na K and Cl CO2 optional ions with ion selective electrodes ISE module The device consists of a reading module with a dedicated sampling arm and therefore can be considered as a stand alone module of the instrument The system is called lon Selective as the electrodes used respond to their respective ions in accordance with the Nernst equation E EO RT nF log aM ion activity E observed potential in Volts EO constant standard potential for a redox semi reaction referred to hydrogen electrode gases constant F Faraday s constant T temperat
235. o 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 Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page I9 of 19 OPERATOR MANUAL BT3000 PLUS SECTION Il ADDITIONAL INFORMATION CHAPTER 2 2 WARRANTY CONDITIONS Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section IT Chapter 2 Warranty Conditions Index BT3000 PLUS Rev 0 Soft Ver 8 2 WARRANTY CONDITIONS Biotecnica Instruments S p A after having accurately tested this analyzer guarantees the instrument for 1 one year starting from invoice The 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 The 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 The 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 clients location transport board and lodging as well If the stated defects
236. oceed 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 Section I Chapter E Operating Procedure BT3000 PLUS procedure starts automatically Rev 0 Soft Ver 8 Page 4 of 19 If there no samples in the plate then answer 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 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 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 5 Im
237. ode 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 Remove sector After the choice has been made the analyzer will correctly memeye Sector 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 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 3 information Volume ml Mum Samples Ma
238. of programmed tests The message ERROR RESETTING REAGENT TRAY is activated by an incorrect zero 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 te
239. of the generated list and no physical position is assigned to them Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 32 of 32 OPERATOR MANUAL BT 3000 PLUS SECTION I GENERAL INFORMATION CHAPTER D 1 PERFORMANCE AND LIMITS Page 2 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Section I Chapter D Performance and Limits Index BT3000 PLUS Rev 0 Soft Ver 8 1 PERFORMANCE AND LIMITS PERFORMANCE Operating Mode Random access Methods Tests for Clinical Chemistry and Immune Chemistry S E Module Na K Cl CO optional Test Mode Routine Batch Emergencies STAT Profiles Tests on line 80 refrigerated reagents Relation Tests Tests in memory 500 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 34 cuvettes made of special optical glass Samples Tray Capacity 52 positions for Samples amp STATs 26 for 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 require
240. ofiles 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 Surname Type Assigned Group Serum Routine Urine CTRL Routine Name Draw Date External dilution factor 05 03 02 fi 00 Ar CM Test S Profile SE Delete E Save B Run Exit Child Available profiles Analyses C aa Select NE CoH ela Deselected E selectable tests 50 Remaining 50 Figure 8 Delete Cancels the programmed patient Confirmation is requested 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 s
241. ollows a 1 alarm Beep of 1 second frequency The LED on the waste probe will be lit The external waste container is full Empty it In the mean time vacuum pump continues to function without blocking the analyzer for about 4 minutes as the waste chamber inside vacuum pump system is being used It is important to press the RESTART button on the vacuum pump cabinet to continue the operating procedure and to reset the alarm b 2 alarm Beep of 0 5 second frequency The LED on the waste probe will be lit This alarm is activated when the external waste container is not emptied and the waste chamber inside the vacuum pump system is full A signal is sent to the analyzer to interrupt the operating functions with a Waste Bottle Full message c The Waste Bottle Full message will stop analyzer function Once the cause of the message is remedied the command Start Another Tray can be selected to carry on the operating procedure with the analyzer Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 11 of 19 2 12 CARE AND MAINTENANCE Refer to FIG 2 3 amp 4 It is highly recommended to replace every 6 months the peristaltic pump cartridge P N 330 9088 and the Hydrophobic Filter P N 662 0807 located inside the vacuum pump cabinet a b N CAUTION HIGH VOLTAGE INSIDE HAZARD OF ELECTRICAL SHOCK PUMP WIRING IS LIVE DISCONNECT INPUT POWER POWER CORD BEFORE SERVICING NEVER OPERATE WITHOUT S
242. on II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 19 1 3 Analytical Calibrations and Controls CALIBRATIONS The analytical calibrations that can be run by the analyzer are divided as follows With Factor Linear and Non Linear The selection occurs during the programming of the analytical test parameters refer to Chapter C paragraph 1 3 3 Primary Analytical Parameters and can be executed on user s request or automatically Linear and With factor analyses Standard parameters for 001 Factor This parameter converts absorbance ABS values detected by the analyzer into final concentration E values When a theoretical factor is used i e With Factor methodologies enter in this field the known Range limit Wi EF factor The analyzer when calibrating calculates and 00 0200 Tine selection updates the factor value ziv replicates 2n u Range limit In order to verify calibration s validity enter hoo BERE as the Minimum and Maximum range in which the factor must be included If an out of limit factor is detected a a message informs the user and the previously stored value is not modified 50 0 oo o nay Calibrators or standards used must be placed into E dedicated positions on the samples tray It i
243. on procedure for the stored calibration curve Enable with check Re calibrating on single point then enter in the Calibration point the position number corresponding to the Number field 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 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 Section IT CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page amp of 19 CONTROLS The controls are divided into Known and Unknown where it is possible to program three levels for each one subdivided in tables Known Level 1 2 3 Unknown Level 1 2 3 TestParameters Standards And Controls Globa 000 Print paramet Print paramete 5 5 Control parameters for 001 Control parameters for 001 2 0000000000000 Known Unknown 0 Known if Unknown Lot name Lot name Lot name Insert re run timing At hour a1 si Sample position 21 si Sample position sj Sample position Each zi Day s C
244. on that allows direct access Save Memorizes data Exit To leave exit the program Print To print data Into the window Fig 30 the All tests list Available is displayed 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 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 gt 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 for 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
245. ons 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 CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page l of 19 1 ABBREVIATED OPERATING INSTRUCTIONS The BT3000 PLUS is an automatic analyzer for clinical chemistry immunochemistry analyses and for electrolytes determination of and CF through lon Selective Electrodes ISE Module It is possible to add the CO electrode optional to the ISE Module The instrument is a fully automatic analyzer for processing serum urine and plasma samples 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 BT3000 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 full meaning of each command will be explained in the corresponding chapters At the start up the program will display the following main window Fi Plus eo Patients Tests Analyzer Utility External Programs 600600000006 Insert Routine STAT Insert Batch Run all pendin
246. ons or totally occluded Figure 6 Figure 6 Chapter N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 16 c Sampling arms and sampling tubes The analyzer does not monitor the sampling arms maintenance Two sampling needles refer to No 12 in Table of Figure 2 are provided for yearly replacement or when necessary in the annual maintenance kit SAMPLING NEEDLES SAMPLING TUBES Figure 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 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
247. ontinue the operating procedure and to reset the alarm Audible Alarm of 0 5 second he external waste container is not frequency with the LED on the emptied and the waste chamber inside the waste probe lit vacuum pump system is full In this case a signal is sent to the analyzer to interrupt its functions Empty the external waste container Press the RESTART button to reset the alarm The vacuum level below In the normal operating conditions the 200 mbar 150 mmHg vacuum range may vary between 250 mbar 188 mmHg to 400 mbar 300 mmHg The vacuum level below 200 mbar 150 mmHg indicates leakage in hydraulic circuit Ensure that the waste tube blue tube connecting vacuum pump to the analyzer and the exhaust tubes in the analyzer are firmly connected b Partially occluded hydrophobic filter located inside vacuum pump system Replace with Part No 662 0807 Caution Always install filter with flow flow directional arrow pointing towards the pump entering the vacuum pump from the waste chamber side Damaged Unit The unit has suffered severe shock such as being dropped Do not use the unit Consult your dealer regarding repair Liquid such as water has been otop using the unit immediately and sucked into the vacuum pump disconnect the power supply Consult your dealer regarding repair omoke strange odor or noise Stop using the unit immediately and disconnect the power supply Consult your dealer regarding repai
248. or conversion of absorbance values ABS determined by the analyzer into the final values of the Te 2 concentration Enter the factor value if known or else leave the displayed value because the analyzer after each Tu calibration calculates and updates the data In order to ABS 0 000 verify calibration s validity enter the Minimum r Maximum range in which the calculated factor must be Last Standardization ee Reagent ABS lt Not Performed gt 1 Pos 2 100 2 trom last calibration included After the determination of an out of limit value a rues ee Em IR E message informs the user and the previously stored value Qeon _ is not modified If the values for concentration and L Enable Auto Adjust absorbance are known it is possible to process mathematically the factor through the Calculation Figure 25 command Section I Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver S Page 27 of 32 Timed re run standardization time Using this parameter it is 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 cali
249. ort 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 ordering 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 Start up of the general setup program of the BT3000 PLUS Floppy disk formatting Section Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 17 of 23 3 1 SELECTION How to run a Query File Utility Delete 5232 Help 9 9 9 Choose Date Choose Code Choose Name Arrangement gt Select All Selecta z E Select Al al C Cod Choose Sumame C Sumame Select All ES eds E 0003426 Bianchi Paolo Mal 27 02 2003 95445 Questa nota abbast 0002621 Fedi Francesco Mal 27 02 2003 9 54 46 Questa nota abbast 0007502 Doh Robert _ Mal 27 02 2003 9 54 47 Questa nota abbast 0002
250. ositions 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 The Figure 2 shows the reagents volume status and the sample diluent for the ISE Module The symbols 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 BT3000 PLUS Rev 0 Soft Ver 8 Page 20f 19 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 barc
251. paragraph 1 5 Calibrations Both choices can coexist The commands are Immediate Standards and Timed Standards Fig 4 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 the 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 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 pr
252. parameters Check Parameters Secondary parameters Normal range Serum Normal range Urine Min Max Min Max 0 000 Reagent limit mABS 0 000 0 000 0 000 Reagent limit 485 0 000 0 000 Man Prin 100 Curve Acceptance 2 fo 000 0 000 Woman f 00 Curve Acceptance A fo 000 0 000 Woman Serum Urine 0 000 0000 Child Serum Urine Chid J Re run hyperactive t Profile J Re run hyperactive 2 000 Test imit Conc 0 000 Test imit Conc S Frome Mm 4 pathological 0 000 Initial ABS mABS range a Initial ABS 5 ie nic range 3000 2 Min Max 3000 Min Max Final ABS mABS 0 000 0 000 Man Fees ees 0000 0000 Man 2000 2000 Max ABS Delta mABS 0 000 0000 Woman Max ABS Delta mABS 0 000 Woman Check Prozona Check Prozona C Enable hid Enable no hid fiat mABS 09 paps pathological ke Figure 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
253. pecial 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 the problems have been solved Every time a new reagent bottle is insert
254. ph 1 7 ACCESS PASSWORD regarding the utilization of the password Prime the hydraulic circuit using the commands outlined in Chapter H paragraph 1 1 Service Functions Dilutor prime Wash and fill up I S E module prime for the last command it is necessary to set the analyzer with working solutions for the ISE module refer to Chapter L FLOPPY DISK AND CD ROM POWER PUSH BUTTON FOR COMPUTER Section I Chapter B Unpacking amp Installation BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 10 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 Bam a of the photometer Wait 20 min from start up Wash the cuvettes with the proper solution the cuvettes with the proper solution Before turning off Wash of t
255. ple Starter This parameter if enabled allows separate dispensation between sample and reagent To enable click on this box to confirm e 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 O incubation time e 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 e Reading Time The user must enter the total reading time in seconds keeping in mind that the analyzer performs a reading every 10 seconds The possible values range from 0 to 990 s Section I Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 22 of 32 1 3 4 Check Parameters Parameters for Clinical Chemistry XXX Parameters for Clinical Chemistry XXX Primary parameters Check Parameters Secondary parameters Primary
256. r Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page I4 of 19 2 17 CLEANING OF THE HYDROPHOBIC FILTER Vacuum Pump System BT3000 PLUS amp BT2000 3000 TARGA Normally during the routine maintenance the hydrophobic filter located inside the vacuum pump system is replaced approximately every 12 months Sometimes the filter may become occluded after a short period of time or suddenly These occlusions are generally caused by the presence of excessive foam formed in the waste liquid by agitation This can happen if an excessive amount of surfactant detergent is used in the washing liquid or reagents containing too much surfactant Even if there is a waste chamber in the vacuum pump system to attenuate the problem the foam may overflow from the waste chamber into the hydrophobic filter before the liquid level detector turns off the vacuum pump Observe the following procedure to resolve this problem 1 When the external waste container is full the system generates an audio visual alarm The operator must intervene soon to avoid overfilling of internal waste chamber causing foam to overflow into the filter 2 Regeneration of the filter through cleaning This operation is possible if the filter is occluded recently and has not exceeded its current operating life In practice an old filter with membrane occluded by dried up residues must be substituted 3 Disconnect the power cable Remove the cover from the vac
257. r differentiated aspiration of waste fluids from the analyzer The vacuum pump system consists of the following items 1 Two 2 identical waste chambers in Pyrex for differentiated collection of waste fluids from the analyzer 2 Vacuum pump with hydrophobic filter and a silencer 3 Two 2 peristaltic pumps for emptying the waste chamber fluids 4 Two 2 waste probes with liquid level sensors for inserting in the special waste containers external for safe liquid disposal 5 Four 4 liquid level sensors in Hi Low positions inside the waste chambers 2 3 PRINCIPLES OF OPERATION The fluids aspirated from the analyzer are separated according to degree of contamination into two separate channels Basically the blue tube evacuates less contaminated fluids while the black tube evacuates highly contaminated fluids The peristaltic pump does not empty the internal waste chamber receiving the fluid until the rising liquid level few centimeters actuates the bottom liquid level sensor The liquid level sensor controls the peristaltic pump until the liquid level returns to the minimum position The liquid level sensor is used for operating the peristaltic pump when necessary instead of continuously The liquid level sensor located on the top of waste chamber is for signaling any system error In case of peristaltic pump malfunction the waste chamber will continue to fill up until the liquid overflows into the vacuum pump To prevent this happening the
258. r 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 2 2 PRINCIPAL STATISTICS FORMULAS USED IN POPULATION MODULE Mean X X1 Xn selected elements being n the number of elements Xq4 Xo X 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 2 Xi X 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 CV D5 1 00 X Section Chapter F Population Patient s Archive BT3000 PLUS Rev O Soft Ver 8 Page 11 of 23 Minimum square line 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 particula
259. r prepares dilutes the working LN ll reagents such as Reference Baseline Solution and pr Pa uw em Buffer Solution which are CONCENTRATED Pee ee 1st Unit Enter value in the corresponding field and enable 2 Unit to enter a second value and Figure 4 instantly a new textbox appears where the user can enter the second unit and the second _ unit s conversion factor In case of double units the test values are expressed with two results In analytical calibrations the first measurement unit is used Number of Washes Normally one wash is usually sufficient To set a different number of washes maximum 9 use up down arrow keys or enter the value directly into the box This option allows the user to set the number of washes that will be run at the end of dispensing the reagent used for the programmed test Incubation Time Incubation time expressed in seconds default value is 2 seconds Reading Time Analysis reading time expressed in seconds default value is set at 4seconds Decimals For setting the number of decimal digits in test results Automatic or Custom If a value is not specified then the analyzer automatically assigns number of decimal digits using the Floating point algorithm Electrodes in use K Na CI CO2 Click the check boxes to select the electrodes to be used among those available here This command selects or deselects electrode Press C
260. r 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 ISE Module operation 4 Barcode operation and programming 5 otress program Access to this program is password protected and is for the exclusive use of the service personnel Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 11 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 i
261. r 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 System Logon Change password The user must 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 expiry date while the other passwords must be changed once every three months Modify Password Password min o chr Confirm Password Accept Cancel NOTE The password must have at least 8 characters The administrator has no access to the instrument but to a special window for th
262. r the median for N odd elements is the X N 1 2 th element Example given the 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 Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 23 2 3 DIAGRAMS Data Sequence Graph EI LJ o m ch m ce kals aal Histogram Stat Histogram Print Preview Correlation Coefficient 0 114 Variance 0 542 Standard D eviation 0 736 Num of Rec 43 Median 6 500 Deviance 22 75 Variation Coefficient 11 16 2 Mean 6 598 Exit Figure 15 By clicking on Data Sequence Fig 15 key the data sequence is displayed Coordinate clicking the information about its position and value is shown by double mouse on a given plotted point coordinates i O c gt Record Mum Range Data ba 1640572001 A 16 05 2001
263. rammed 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 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
264. rators 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 calibration 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 me
265. rature Samples Tray Passwords gt Modify password Old password 9 New password Re enter password Section I Chapter H Figure 15 Analyzer Technical Functions Setup Passwords This function is for personalization of the passwords that grant access to program levels 2 and 3 Fig 15 This operation is reserved for specialized personnel only BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 11 Audio Engine To activate the Audio Engine Figure 17 go to Utility Setup Analyzer System Figure 8 16 Voice choose Present and click adjacent button Figure 16 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 activate Audio Engine Present C Mot Present Figure 16 Audio Engine Select Audio Engine x Test Test String Speed Volume Figure 17 Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page ll of 11 OPERATOR MANUAL BT3000 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 Biotecnica Instruments S p A Via Licenza 18 00156 Rome ITALY Page Page Page P
266. rd To close this wizard click Finish T dl b Section Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 23 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 Getting Started with Windows 2000 EE LEM 512 se My Network AT i Getting Started Places E You can access all your documents programs and m settings From the start button Recycle Bin C24 Ly Connect to Me internet Open Control Panel Click Start point to Settings and click Control Panel On My Documents wj My Computer i Windows Update Programs nal Documents Settings aae i Network and Dial up Connections s Printers Help A Taskbar amp Start Menu Search Run J Shut Down start rd Windows 2000 Pro Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 14 of 23 Double click on Display icon Control Panel t Er EAT re 1 D trol Panel Hardware Cont 0 High Color 16 bit oet Screen area to 800 by 600 pixels Section IT Chapter 5 Software Installation amp Upgrade Add oc Adminis BT3000 PLUS Rev 0 Soft
267. re 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 Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 30 of 32 1 6 CREATING PROFILES Available profiles Analyses GOT CAL GPT f ISE GGT TRG ALK AUR AMY Figure 28 Figure 29 INSERT MODIFY 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
268. 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 problems 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 b ISE Module see Figure 2 ISE MODULE To access the ISE Module tubing remove the plastic lodging for the reagents Slide up the ISE electrodes panel to have an easy access to disconnect the waste tube connecting peristaltic pump to the ISE Module refer to chapter L par 1 4 Replace the Y shaped tubing set 7 by first inserting the single tube end into the bubble sensor and then connect it to the funnel located above Insert the remaining two tube attachments into the appropriate slots tube in the upper slot and the REF tube in the lower slot of the pinch valve and then correctly connect their ends to the REF and K electrodes as shown in the figure Verify correct tubing placement in the pinch valves Replace the ISE peristaltic pump tube 6 by connecting one end to the ground electrode then around the pump head and the other end to the waste liquid connector as illustrated Connect tube 5 to the Co2 electrode or By pass and the ground electrode
269. resent to disable it With bar code enabled further options are On Samples and On Reagents or just one of the two Language System Printer Header Footer Serial ISE Module Working Temperature Samples T gt Present Setup Not Present On Samples 200356789 Setup Bar code on Samples 2 On Reagents F il This function customizes the Setup Bar Code on Reagents Setup Bar Code on Samples jo zi Dimension Sample Code ID O Variable contents of the patient code Use a digit for Serum Urine reported on the bar coded label Length 13 Digits C Length 12 Digits Use one or two digits for profile number Dimension Sample Code This field is used to define the j number of characters dedicated z to the patient code If set to zero Figure 10 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 Creatin
270. rmination 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 concentration 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
271. rofile Number which provides total automation in patient acquisition refer to Chapter C paragraph 1 6 Creating Profiles and Chapter I 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 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 allows 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 patien
272. rs 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 BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 19 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 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 patents Prints the partial for selected items or total samples list Print Select Al Select All Deselect Al Automatically selects the whole list Run d Delete Deselect AII Automatically deselects the whole list confirmation required Scan tray j Scan tray and run 4 Work start command If single patients or the whole list is selected a message asks if the samples
273. s 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 command 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 Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 16 of 19 RESULTS PER TEST fj 223000 Pazienti Test Anali ooga 9 CTRL6724 aaan mg dl 5 03 43 0 102 GLI Glicemia 3 0009457 80 0 ng L 6 93 35 0 96 5 Inserisci Routine STAT 51 0002151 i eee 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 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 ln eee UI L 3 37 33 0 91 5 w PRY 51 00
274. s 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 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 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 hand
275. s e g Additional Serial port Touchscreen and printer CAUTION The supplementary drivers must be installed prior to installation of the BT3000 PLUS operating program in the system Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 18 of 23 9 5 INSTALLATION OF THE BT3000 PLUS OPERATING PROGRAM Insert the CD ROM containing the operating program of the BT3000 PLUS in the CD ROM drive The following screen appears My Documep gt e My Comput J am My Netwo Places E Recycle B Internet 7752 vc dg ws 4 5 ut uum J V 278 u A erie 7 d 2 A 7 i N ae 14 A FE A Ar UP AS gt P NW 4 r LEN me 45 PIPES it a Pa TIG a TUR RENS Click LAUNCH SETUP Now the installation procedure begins which will guide the user during operating program installation Welcome to Analyzer Installation The InstallShield Wizard will install bt Plus on your computer To continue click Next H Cancel BERIE sese Click Section Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 19 of 23 The installation procedure automatically checks the communication port COM used for communication with the 552 In case the communic
276. s 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 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 and statistics generation Section Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 23 2 1 ANALYSIS SELECTION
277. s 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 Web Section II Chapter 2 Warranty Conditions BT3000 PLUS 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 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 gt 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 5 Section II Chapter 2 Warranty Conditions BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 4 Page 1 of 1 53928868258 Mod 05 35a ing Rev 0 Parts Instruments Return Authorization DATE
278. s Samples Figure 3 Special Reagents This command displays the volume status of the ISE reagents ISE washing solution and the special solution NaCl 0 9 diluent for serum Click on the field Special reagents a screen View volumes status special reagents showing a sequence of bottles appear Figure 2 Click on Check volumes the analyzer automatically verifies volume contained in all the existing bottles Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 19 Single reagent bottle Right click with mouse on the desired bottle representation Figure 2 a screen appears with options Insert bottle and Check volume After selecting the option for example Insert bottle the analyzer will verify the volume contained in this bottle Insert bottle Check valume 1 3 RUNNING STANDARDS amp CONTROLS ON DEMAND OR TIMED Select Standards Controls Deselect All Select All e Timed Standards Exit e Immediate Standards Figure 4 The Run Standards and Run Controls functions are menu or through the specific icons that allow direct access Figure 5 available from the Tests main 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
279. s Setup 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 completed installing bt Plus G Ye UN nt to e tart my omputer now will n tart my omputet later ck Finish to exit bt Plus setup start na Plus Setup 1 qu k 9129 Now the operating program has been installed correctly in the system Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 21 of 23 5 6 UPGRADING THE BT3000 PLUS SOFTWARE If a software upgrade disk is inserted or reinstallation of BT3000 PLUS program then the following screen is displayed My Documents My Computer InstallShield Wizard Welcome f te Modify repair or remove th My Network Places Welcome to the bt Plus Setup Maintenance program This program lets you modify the current installation Click one of the options below Modify Bin T2 Select new program components to add or select currently installed components to remove C Repair m 1 im Reinstall all program components installed by the previous setup Internet T 1 Explorer Remove Remove all installed c omponents Connect to the Internet iste c 2 PMinstaishietd wi
280. s 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 reagents volume status for the ISE Module and the sample diluent are illustrated in the Figure 3A The insertion of reagents in the reagent tray for clinical chemistry and in the ISE Module is shown in Figures 4 amp 5 respectively Figure 5 Figure 4 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 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 Secti
281. s highly recommended that operations in the setup program are performed by specialized personnel Language this page 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 LG E Module Working Temperature Samples T Language A O Figure 7 System In this page it is possible to modify the following Language System Printer Header Footer Bar Code Serial 1 5 Module Working Temperature Samples T DU Icons Navigation Ba Visible Invisible C Invisible Visible If selected the patients will put Jd i be sent to the extra patients Voice C Present nt list only if it is not full Print out real time results with color Print out real time results with final report If selected the patients will be sent to the extra patients list in any case C Jn any case options Figure 8 Icons It enables or disables the displaying of the icons on top of the screen Navigation It enables or disables the displaying of the navigation bar on the left side of the screen Voice it
282. s performed At the end of calibration phase the slope is calculated in accordance with Nernst equation Slope s AE log STD high log STD low where AE difference in mV between STD high and STD low After calibrating each electrode optimal slopes are obtained which should be within the following acceptance range K 50 60 mV Na 55 65 mV CI 35 52 mV 22 32 mV NOTE In addition to the acquired slopes values it is important to observe also the potential of the standards mV STD Low and mV STD High in the calibration printout refer to Chapter G paragraph 1 In the optimal conditions these values can be reproduced quite easily with slight variations around nominal value The potential of the standards in association with the obtained slope values are useful for evaluation of a correct calibration When electrodes are not efficient for example when poor or no maintenance has been performed or in case of contamination or degradation of the working solutions Buffer Baseline or STD the potential values vary considerably This results in erroneous slopes indicating that the operating conditions are not optimal However in some cases the potentials have incorrect values but the slopes are apparently acceptable Be cautious with this situation as the precision and accuracy of tests results will be affected by an incorrect calibration The potential values are related to standards thus by changing standard s lot with
283. s possible to use up to 4 different standard concentrations or View used posi Linear en run up to 4 repetitions on a single title and automatic adiust D see position In the linear analyses Figure 6 Programming replicates on a single title Enter 1 into the Number of samples then enter the replicates up to 4 max Select the actual position Pos on the tray for the replicated standard and then the concentration Conc The values are automatically updated in the ABS boxes during the calibration Programming several standards Enter the number of standards to be used in the Number of samples textbox Enter the actual Standard parameters for BIC positions Pos on the tray for each standard and then the TT pic ERR i concentrations Conc The values are automatically pm Ex updated in the ABS boxes during the calibration Number of samples Var 7 J Timed re run t 10 Calibration parameters Var Maximum percentage variation This parameter is for verifying percentage variation It E represents the acceptable difference between the ABS Ih sp values calculated for the different calibration points in 0 000 Reagent 5 Last Standardization lt Not Performed gt 50 0 100 mo case more calibrators are used or repetitions are
284. s superfine particles bacteria condensate and any liquid that may contaminate or damage the pump Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 19 1 2 3 4 7 8 9 2 7 WARNINGS Refer to Fig 4A Read vacuum pump system instructions and warning notices carefully Always make sure that the power cord is unplugged from the unit before performing any installation maintenance procedure To protect the vacuum pump from vibration and impact during shipment it comes installed with a clamping device When unpacking the vacuum pump system make sure to remove two transit screws colored red at the bottom of cabinet to release the vacuum pump Turning on the pump with the transit screws installed will manifest itself increasing the apparent noise level during operation and may damage internal mechanisms For proper Vacuum Pump System operation and safety use only with Biotecnica analyzer suitable for this pump type Biotecnica makes no warranty of fitness for use other than its specific analyzer Do not use the pump unit for cleaning of any laboratory spillages or direct removal of liquids from any container The unauthorized use may result in serious injury and permanent damage to vacuum pump system Do not ever leave the Waste Probe outside its external waste container during the analyzer operation or standby The waste probe must always be kept on the waste container to avoi
285. s 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 Run all pending patients Restarts the work list after an interruption Patients Tests Analyzer Utility Ex Insert Batch srb Repetition for analyses Selects the repetition Run all pending patients Ctr R by analyses upon operator s request Ls Clear Patient List Deletes the entire Repetition far analyses Cl 5 memorized patients list The analyzer will request Clear Patient List confirmation before deleting Figure 1 Section 1 Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS Rev 0 Soft Ver 8 Page20f 32 Tests Menu Fig 2 Tests parameters All 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 an
286. signed 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 must be specified Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page I1 of 19 Position Displays the assigned position on the sample tray Test Generates the Analysis List Select each analysis to be performed on the sample Profile oelect 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 oaves 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 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
287. sm 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 poc ED Pin E BarCode Test methodology Test methodology Method Method End Point 44 Reagents E End Point zi Reagents E 9 sawe FD C _ some FD Limes 40 gt Limes Reaction directi ing 4 From From Figure 14 Figure 15 Reaction direction select the kind of absorbance 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 Section I Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS
288. splays 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 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 Setup Analyzer Shut Down Figure 4 Section Chapter Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page 3 of 32 Note The analyzer switches automatically to standby mode when left unused for 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 prog
289. sts contact approved technical assistance The message Impossible to reset analyzer indicates a system 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 N Maintenance amp Troubleshooting BT3000 PLUS Rev 0 Soft Ver 8 Page 15 of 16 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 perform Photometric Zeroing refer to Chapter H paragraph 1
290. sults 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 Chapter G Displaying and Printing Results BT3000 PLUS 0 Soft Ver 8 Page 2 of 8 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 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
291. t 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 Select Analysis Select Method Group Test Type Date Range DOM M D From C D M M Male Serum 03 03 2003 04 03 2003 Female Urine Results Range Child From Ta elation 1 000 20 all 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 Section I Chapter F Population Patient s Archive BT3000 PLUS 0 Soft Ver 8 Page 16 of 23 3 PATIENTS ARCHIVE Choose Date Choose Code Choose Name Select All Select All ze Select All za Choose Surname Select Al A Arrangement C Code Figure 22 The Patients Archive module displays patients information and allows rep
292. t 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 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 14 of 19 Global Insert View patients The Functions menu in the Global Insert View patients fig 13 bar provides access to the following commands Global Insert View Patients Functions Hun all pending patients E ce Control Repetition for analyses STAT TUN E ew Entr H5232 y ent Tray Routine i Clear Patient List Extra Patients Rout Options Dr Figure 13 Run All Pending Patients A sole command for runni
293. table tests 50 Remaining 50 Figure 14 After the selection of Routine followed by confirmation through command New Entry the patients acquisition frame is displayed Figure 14 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 clone 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 As
294. taneously the analyzer enters the standby mode and a corresponding warning message LOW PRESSURE appears on the screen NOTE The liquid level sensor is magnetically actuated reed switch make and break type Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 19 1 4 INSTALLATION amp OPERATION 1 Connect the Blue and Black waste tubes from the right side of the analyzer to the appropriate quick connect on the vacuum pump cabinet front panel Fig 1 2 Connect the Waste Probe electric cable liquid level detector and the drain tube of to the vacuum pump cabinet front panel Fig 1 and Fig 3 3 Insert the Waste Probes in authorized external waste container 4 Plug the power cordset to power inlet on the rear of vacuum pump cabinet and then into one of the accessory power connectors on the analyzer rear panel 5 Now the system is fully installed and ready for operation 6 Switch on the analyzer The vacuum pump will start running NOTE The vacuum pump system power inlet on the rear has no ON OFF switch The system turns ON and OFF simultaneously with the analyzer The vacuum Pump System is equipped with a universal power supply of 90 to 240 Volt AC 50 60 Hz similar to the power supply of BT3000 PLUS 1 5 MAINTENANCE AND CARE This compact pump system is virtually maintenance free and offers continuous duty collection of waste liquids outside the analyzer Does not require inconvenient peristalt
295. tarts 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 19 New Entry STAT After the selection of STAT followed by confirmation through New Entry the STAT acquisition frame is displayed Figure 9 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 saved 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 E B 8 o eun Routine STAT Control Standard New Entry Extra Patients STAT Options Options Insert Routine STAT Insert Batch Run all pending patients analyses Clear Patient Lis Figure 9 New Entry Controls Once the icon Controls is s
296. ted 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 o Verify the presence of the washing liquid at least for the daily needs It consists of bi distilled plus surfactant 1ml l 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 Figure 1 Analyzer s utilities Direct Access con ED Wash cuvettes gt Run a dilutor prime by the command Dilutor prime Fig 2 Run a wash by the command Wash and fill LS Pr Dilutor prime F C C calculation 33 up gt After the instrument has been turned on for 20 minutes warm up time run a photometric NA I S E E Fluidics zeroing by the command Zeroing on water Exit Figure 2 Section CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 19 Section II 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
297. tes washing through the two tubes Blue and Black tubes respectively are transferred to an internal waste chamber made of transparent Pyrex From here the waste fluid is ejected to the external waste container through the waste probe equipped with liquid level sensor B Whenever the external waist container is full the waste probe liquid level sensor activated audio visual alarm alerts the operator and instantly shuts down the pumps Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 2 of 19 1 2 SYSTEM CONTROL FUNCTIONS Pressure Three LEDs on the front panel indicate the system vacuum level Green LED Normal operating vacuum level approximately 60 millibar Yellow LED Low vacuum level below 40 millibar Red LED Vacuum level lower than 15 millibar Alternating Green Yellow and Red LEDs Indicate high vacuum level higher than 300 millibar All LEDs turned off Pumps disabled The green LED indicates that the system is functioning properly The yellow LED may indicate an operating limit condition still satisfactory but signaling the beginning of vacuum level deterioration The red LED indicates vacuum level failure due to various reasons The alternate lighting of Green Yellow and Red LEDs indicate excessive vacuum level probably caused by an occluded waste probe tube from the vacuum pump system to the external waste container All LEDs turned off condition is reached when the standby t
298. 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 Linear and With factor analyses With Factor This parameter converts absorbance ABS E Calculation values detected by the analyzer into final concentration values A text box field appears Figure 25 where it is Factor Minimum Maximum 1 00 1 00 1000 Range limit gt Nurnber of samples 0 ER possible to enter the known factor reported in the 100 2 NE methodology while the ABS value of reagent detected by F EIN 100 00 00 the analyzer is represented contextually Linear Range limit Factor and acceptable Limit A parameter f
299. 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 1 4 SAMPLES 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 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 6 d E outine Control Standard Extra Patients Routine Options E New Entry E Ld d wd d d Wu d d di d di dI dI d dj Wi Ld d wi wr d wd d di d di dL d dj dj di a L3 5 El i 13 15 17 19 21 23 29 27 29 31 33 35 37 39 Ss Ld Sls ls Hd a C o NOTE Point the cursor on the desired option and click to confirm Section I Chapt
300. the lamp can be used for about 1 500 hours The long term use will result in the gradual deterioration of the UV emission 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 ISE System Concentrated Buffer Solution 50 ul 400 ul H20 Concentrated Reference Solution 50 ul 400 ul H20 Sample Volume 30 ul Concentrated Buffer 10 ml 200 tests Concentrated Reference Solution 10 ml 200 tests RESIDUAL VOLUMES FOR REAGENT BOTTLES NEW SERIES 80 ml BOTTLES Approx 50 ml BOTTLES Approx 20 ml BOTTLES Approx 10 ml BOTTLES Approx Section I Chapter D Performance and Limits BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 5 ISE MODULE Number of electrodes Analytes Test execution time for ISE Sample throughput Analytical throughput Reagents Sample Type Sample Volume Concentrated Reagents Dilution Dilution of Serum Buffer Precision on Serum test Precision on Urine test Linearity for Serum test Linearity for Urine test Accuracy for Serum test Intra Run Serum N 20 s
301. 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 delta 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 INCUBATION INCUBATION DELAY TIME TIME READING TIME DELAY TIME TIME READING TIME Section 1 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver S Page I1 of 32 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 AI A2 A3 AI A2 A3 DELAY TIME Eco READING TIME DELAY TIME She dii 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 kineti
302. 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 to give at the end the concentration of the compound into the sample The ISE lon Selective Electrodes module is a device dedicated to the determination in the samples of the electrolytes Na plus a channel for an optional electrode see chapter L This device is defined as ion selective as the used electrodes react with the corresponding ions in accordance with the following Nernst law E RT nF log aw aM M ion activity E potential in Volt E constant H electrode redox semi reaction std potential R gas constant F Faraday s constant T temperature expressed in Kelvin degrees n ion charge The average life of the electrodes is approx one year for sodium and reference approx three months for potassium and approximately six months for chloride and carbon dioxide However the electrodes life is dependent upon the number of sample runs and the routine maintenance procedures outlined in this manual Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 11 3 SYMBOLS EXPLANATION OF THE USED OR APPLIED SYMBOLS As the BT3000 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
303. 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 Protocol it is possible to use the internal communication protocol or a variable protocol When choosing the variable protocol it will be possible to set the protocol options by clicking on the dedicated icon Only expert operators should set the variable protocol see Chapter 4 Section Il paragraph 4 2 Language System Printer Header Footer Bar Code Serial 5 Module working Temperature Samples T a LS E Module Activates the 5 Module LG E tc ISE module Figure12 Check Present Present to activate or Not bo Present to deactivate When the ISE module is disabled all relevant menu options will be disabled too or not visible at all Figure 12 Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page9 of 11 Working Temperature Sets working temperature for reading cuvettes and activates the Luvettes Temperature C Room Temperature E 37 C Language System Printer Header Footer Bar Code Serial 1 5 Module Working Temperature Samples T4 gt Set up pressure Minimal pressure 40
304. tients 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 Running Tests and the Chapter E paragraph 1 5 Work Lists Section II CHAPTER 1 Abbreviated Operating Instructions BT3000 PLUS Rev 0 Soft Ver 8 Page 13 of 19 1 5 Running Tests Once the data has been entered insert the samples into the tray Figure 17 and then place the analyzer into the tray Figure 18 Figure 17 Figure 18 Options The Options menu is available in the Current Tray Routine STAT and Controls It displays the following commands Send to extra patients Options Send to extra patients Print k Select All Deselect All Run k Delete Scan tray d Scan tray and run k 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 Print Prints the partial for selected items or total samples list Select All Automatically selects the whole list Deselect All Automatically deselects the whole list confirmation required Run Work start command If sin
305. tion 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 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 maintenan
306. tion II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page amp of 23 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 NEXT in both the screens Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 9 of 23 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 i n esas BER Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 10 of 23 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 0 Completing the Windows 20 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 Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page I1 of 23 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 Ne
307. tion is not used then separate reports are obtained Duplicate patient By clicking on the icon 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 Surname 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 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 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 Section I Chapter E Operating Procedure BT3000 PLUS Rev 0 Soft Ver 8 Page 8 of 19 Profiles Select Deselect Tests Profile The stored Profiles list Fig 8 is displayed through this command refer to Chapter C paragraph 1 6 Creating Pr
308. tors 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 Chapter C Functions Analyses Prog Ctrls Calib BT3000 PLUS 0 Soft Ver 8 Page 28 of 32 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 calib
309. trol 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 11 011 36 Range Statistics 15 0 11 46 Number Mean Min 10 0 5 00 23 0 12 00 Theoretical 20 0 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 Chapter F Population Patient s Archive BT3000 PLUS Rev 0 Soft Ver 8 Page 3 of 23 1 3 DISPLAYING amp PROCESSING BY LOT PAIRS JUDEN GRAPH After selecting the key parameters Analyses Lot Method Type 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
310. ts for test results will be displayed for test 1 1 RESULTS PER PATIENT Results 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 ug 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 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 re
311. twork Identification Wizard Welcome to the Network Identification Wizard This wizard helps you connect your computer to a network continue click Next Click NEXT key Enter user name who will log on to the system STRICTLY OBSERVE THESE INSTRUCTIONS Network Identification Wizard Users of This Computer Who can log on to this computer PERT SEER ES EERE t we avec Od icu us in ndi TER ji ndows assume the same usar will mee ba o this h h option do you prefer i i VIAE m Bits nn Users must enter a user name and password to use this computer i ve a T Hu PR Ne Windows always assumes the Following user has logged on to this Administrator X erm 1 2 tW t Password Confirm password vmi toc vy e Nn ms 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 Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 12 of 23 The Windows installation has been completed Click Finish to exit mmm Identification Wizard BUS Completing the Network Hii Identification Wizard if 1 m fi ns J d di AT 4 a 7 You have successfully completed the Network m Wiza
312. uantity 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 bt 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 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 s
313. ul while the maximum allowable volume is 700 ul 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 Ml Diluent the volume of diluent to be added to the concentrated reagent For example for a dilution ratio of 1 2 write 100 for the concentrated reagent and 200yl for the diluent The dedicated diluent is considered by the analyzer as a further reagent and will therefore take a position of its own in 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 programmed 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 Code X BarCode EE Print Test methodology Sample pl Prim
314. umber of invalid analysis Invalid Data not through variables Invalid Data through variables 4 An analysis variable is outside the SET BEGIN END relative to the analysis Section II Chapter 4 Serial Communication BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 18 Notes regarding Scripts A script is a text document Each one of the single commands must each reside in a different 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 TYPE OF DATA Character 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 If for example we want to identify the character
315. upper liquid level sensor is actuated which disables the system by turning off the vacuum pump Instantly an audible alarm is activated intermittent acoustic signals of high frequency The waste probes transfer the liquid ejected from the peristaltic pumps into the external waste containers For safety reasons each waste probe is equipped with a liquid level sensor which is activated when the external waste container is full In this condition the vacuum pump system generates an intermittent audible alarm of low frequency and simultaneously the red led on top of the waste probe is lit NOTE The liquid level sensors are magnetically actuated reed switch make and break type 2 4 Vacuum Gauge The vacuum status is clearly indicated on the front panel vacuum gauge 2 5 Vacuum Level Regulator The pump circuit incorporates an automatic vacuum level regulator which is factory set at 400 mbar 40 kPa 300 mm Hg 11 8 in Hg The vacuum regulator monitors the vacuum level and automatically adjusts it when the vacuum level rises above the desired point in the event of clogged filter or any other system occlusion By using the vacuum regulator the risk of a pump failure due to excessive is eliminated extending the pump life and ensuring high performance 2 6 Hydrophobic Filter A disposable hydrophobic filter protects the vacuum pump from contamination If the filter becomes clogged it may be replaced any time The hydrophobic filter capture
316. ure in Kelvin degrees n ion s charge It is highly recommended to carefully read this chapter before using the system The user should also keep in mind that all the ISE components must be maintained in optimal operating conditions to ensure precise and accurate determination of results The correct use by the well qualified personnel assures quality test results as well as a longer duration of the electrodes Lifetime for electrodes is about 1 year for sodium and reference 3 months for potassium chloride and carbon dioxide However the electrodes lifetime depends upon the number of samples determined and the observation of routine maintenance at proper intervals For a correct use of the system the user must observe some basic functions such as initial restoring for electrodes conditioning calibrations repeated every 4 hours or at any temperature variation that is greater than 3 C and at the substitution of working solutions Buffer amp Reference When turning off the analyzer it is necessary to perform a washing procedure with appropriate detergent solutions This chapter gives some operating suggestions and GLP to help assure precision and accuracy of the system The ISE module Figure 1 is located inside the right side of the analyzer The ISE reagents are positioned near the ISE module and are accessible through an appropriate panel The module can be removed by opening the panel and extracting it upwards all fluidic tubes must
317. ution Arm on buffer solution ISE Same as above but for the buffer solution Arm on reference solution ISE Same as above but for the reference solution Cuvettes position ISE The sampling arm moves over cuvettes tray The sampling needle must be centered on the cuvette Section I Chapter H Analyzer Technical Functions Setup BT3000 PLUS Rev 0 Soft Ver 8 Page 4 of 11 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 4 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 The procedure is identical for the instrument equipped with ISE module and the second sampling arm Follow the guide shown on the right side of the page for relevant positions 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
318. uum pump system Remove the filter tubing from the internal waste chamber and the vacuum pump quick connects metallic Turn the filter upside down with the flow arrow indicator Do on the filter Fig A must point upwards Remove the vent cap Fig A at the bottom of the filter and drain any liquid inside the filter Use a plastic pipette on the top opposite to flow arrow indicator to blow out any liquid or wet residues from the clogged filter membrane Now about 90 of the filter efficiency must have been restored Best results can be obtained by using compressed air in place of the pipette 4 Replace vent cap Fig A and tighten it Install the filter and the vacuum pump system cover and tighten screws Apply Plastic Pipette or Compressed Air Applicare Pipetta Plastica o Aria Compressa Figure A Vent Cap Tappo uscita liquido Section I Chapter K Vacuum Pump System BT3000 PLUS Rev 0 Soft Ver 8 Page 15 of 19 2 18 USER SERVICEABLE SPARE PARTS Operator Maintenance is limited to the following spare parts Warranty will be considered void if any other part of the Waste Suction Pump Unit is tampered with during the warranty period PART NO DESCRIPTION 330 6340 FUSE 250 VOLT 2 AT 230 VACUUM PUMP SYSTEM 330 6342 FUSE 250 VOLT 4 AT 115 VAC VACUUM PUMP SYSTEM 330 6400 MAINS POWER SUPPLY CORDSET 330 9088 CARTRIDGE PERISTALTIC PUMP FIG 2A 330 9623 ELBOW FITTING FOR PERISTALTIC PUMP CARTRIDGE 330
319. ways be closed after the ISE determinations as the in the solution degrades when exposed to air for more than three days If slope should drop below 15 then replace the buffer solution and calibrate again If the slope is still low even with a new buffer then replace the electrode If one of the two solutions buffer or reference is replaced then the calibration should be performed again to avoid possible incorrect results If the electrodes are removed for any reason then carefully note down the electrodes sequence positions The potassium electrode K must be immediately detached by disconnecting tube from the next electrode Na in the stack and maintained in vertical position because even a small reflux of liquid from Cl and CO electrodes can destroy it Carefully observe the liquid flow direction in the ISE module fluidic circuit Liquid s flow should be clockwise while hydraulic pump should rotate counterclockwise The electrodes should be washed every day even if the ISE module has not been used for some time This makes the electrodes more stable and guarantees a longer life Section I Chapter L ISE Module BT3000 PLUS Rev 0 Soft Ver S Page 12 of 17 1 9 SUGGESTIONS FOR PERFORMANCE MAINTENANCE To eliminate any problems during ISE operation observe the following suggestions Before a long period of system s inactivity proceed as follows a Perform an extra wash refer to Chapter H paragraph 1 1 1
320. will result to be out of warranty limits the buyer will pay repair or replacement costs Biotecnica 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 Biotecnica Instruments S p A is an internationally known for its high quality standards in production Biotecnica Instruments 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 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 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 users 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 profit s loss business interruption or information loss cannot be ascribed to Biotecnica Instrument
321. window Save Save saves the program and closes the window Pr int Print prints the window s contents i e parameters graphs etc Reduces the window to the upper bar where the analyzer s name appears 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 EHE e ooo 1 Refrigerator enabled Refrigerator disabled Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 6 of 11 IVD SYMBOLS PRINTED PACKAGING ITEMS Caution consult instructions for use In vitro Diagnostic Medical Device Catalog number Manufacturer Lot number or Batch code Storage temperature BER s Expiry date Biological hazard Risk symbols CE Logo Directive 98 79 CE XxX T8 Section I Chapter A System Description BT3000 PLUS Rev 0 Soft Ver 8 Page 7 of 11 SYMBOLS APPLIED ON THE ANALYZER Direct current Pam M Alternating current P Both direct current and alternating current Earth ground CL Protective earth conductor terminal 7 7 Chassis ground terminal Equipotentiality ON Main supply OFF Main supply n Equipment protected throughout by double insulation or reinforced insulatio
322. zard Select the option Remove and click NEXT NOTE The ensuing procedure will remove only the executable files but not the data A screen Confirm File Deletion appears oe A My Documents LJ My Computer Welcome ao Modify repair or remove the pro ie My Network ma Places Welcome to the bt Plus Setup Maintenance program This program lets you modity the current installation Click one of the options below Modify Ir Recycle Bin Confirm File Deletion x Do you want to completely remove the selected application and all of its components i gt Internet Explorer d ji Remove all installed components J Connect to the Internet lristallShield Ok 51 A Ca fElinstalishieid Wizard Click OK Section II Chapter 5 Software Installation amp Upgrade BT3000 PLUS Rev 0 Soft Ver 8 Page 22 of 23 Wait for the completion of the procedure 2s My Documents de My Computer A e Maintenance Complete My Network Places Finish Tc starl rt E E ER 9 30PM 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 N My Documents P InstallShield Wizard P My Computer End installation

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