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- Frank`s Hospital Workshop

1. Test RATIO Incubation time Sec 60 Mean normal value 12 8 Next test or Main Menu Single test Change Yes 1 No 2 Yes Test RATIO Test RATIO Single Test Mean normal value 12 8 Change Single test Press ENTER to Duplicate Test 2 save new entry Press ENTER to continue Duplicate test Single test Press ESC to Cancel Test RATIO Test RATIO Max Difference 10 Incubation time Sec 60 Press enter to Press ENTER to save new entry save new entry Press ESC to cancel Press ESC to cancel NOTE The keypad must be set to INR Ratio O M V 1 1 2 49 07 03 30 Ke 49 Amelung 5 6 INR International Normalised Ratio The INR International Normalised Ratio is the preferred method for reporting prothrombin times in the USA The PT activity curve and ratio are preferred in Europe The following values are only example values and should be replaced by the values given in the test application Call up the test configuration and the INR test section 5 1 Following will be displayed on the screen Select Yes lt 1 gt to modify the settings Test INR Press No lt 2 gt or lt gt cancel and retain the original a aeia ene eea eis settings for the INR configuration The next test will be Default value 12 8 displayed ISI Value 1 03 Single Test Change Yes 1 No 2
2. 1 Plug the Instrument power cable into the power socket located on the back of the Instrument Connect to line voltage 2 If applicable Plug the printer accessory power cables into the corresponding accessory power sockets Connect to line voltage For the KC1A AMAX Destiny and AMAX 200 a total of 2 for the AMAX 400 a total of 3 and the KC4A 1 line socket s must be available 3 AMAX 200 AMAX Destiny Connect the mouse keyboard and printer to the integrated PC appropriate connection points are clearly marked on each PC ATTENTION The mouse is connected to the bottom connector and the keyboard connector is on top 04 01 21 W SI 5 bieech Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 7 Power ON AMAX series WARNING Assure that the shipping safety clamps and tape have been removed AMAX series As appropriate ensure that the instrument safety shield is in position The alignment plug rods on the instrument lid must be properly seated in the corresponding hole clips on the top of the instrument All instruments Power up the instrument by pressing the power supply switch from OFF 0 to ON I WARNING Do not switch OFF 0 and ON I rapidly Wait 10 15 seconds after switching OFF before switching ON AMAX series If the instrument has an automated sample and reagent dispense system at power ON I the robot arm if positioned in the well will move to the h
3. For single testing select lt 1 gt Single test For duplicate testing select lt 2 gt Duplicate test Test INR 5 ae Single test Press lt gt to cancel and retain original settings Change Single test Duplicate test 2 Press ENTER to continue If duplicate test is selected enter the maximum difference permitted between duplicates and press lt gt to save the new entry Test INR Max Difference 5 Press lt ESC gt to cancel and retain the original settings Press ENTER to The difference will be calculated as follows save new entry ress o cancel Difference Difference between Measuring and Average value x100 eae Average value Tests INR Incubation time Sec 60 Enter the incubation time contained in the test application and press lt gt to save the new entry Press ENTER to save new enrty Press lt ESC gt to cancel and retain the original settings Press ESC to cancel Tests INR Enter the Mean normal value in seconds and press lt gt ee ae ee oe ee eee to save the new entry i ages 4 Press lt ESC gt to cancel and retain the original setting Press ENTER to save new entry Press ESC to cancel 50 O M V 1 1 2 07 03 30 Kc 49 Amelung Enter the ISI contained in the reagent box insert and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original settings In conclusion all v
4. Parafilm is a trademark registered by American Can Company Greenwich CT USA O M V 1 1 2 07 03 30 71 Kc 49 Amelung A Appendix A 1 INR Fast Track Note Use the Multipette See section 5 for information regarding programming Activate the RUN Menu by depressing the lt RUN gt key Select lt 3 gt Start Single Test Program Select lt INR gt Enter the number of samples rack Enter the Patient ID Warm the Thromboplastin reagent to 37 C Place cuvettes in the sample rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using Tetravettes Dispense 50ul of sample into bottom of each cuvette Close flap remove rack from preparation area and swirl gently 4 5 times Transfer rack into the heated incubation area or into the rotating test positions Incubate for a minimum of 60 seconds up to a maximum of 180 seconds Press to prepare the Incubation Timers and then press for each activated measuring channel The activated measuring channels are indicated by 1 2 3 or 4 in the bottom line of the Operating Screen Upon completion of incubation timing the corresponding READY field will display 14 Upon completion of incubation timing place rack into the rotating test positions and open the flap 15 Press and hold the lt START gt key Using the Multipette dispense 100uI the PT reagent in the correct order into the cuvettes Start with the measuring channel on the left
5. lt 2 gt or lt gt to save the new entries The FAC or FAC test is configured The parameters for the next test will be displayed If there is no next test the Main Menu will be displayed If incorrect values were entered by mistake select Yes lt 1 gt to repeat the whole data entry routine 60 Inverse Calibration curve Are you sure Yes 1 2 No Point 1 3 100 0 Sec LOB Point 2 ES 25 0 Sec ZED Poa t 3 3 12 5 Sec 34 4 Max Difference amp 5 Change yesLi1 NoL2 07 03 30 Kc 49 Amelung 5 13 FAC Factors Flow Chart Whe Se BAC IR A teu yan ht 08 ACCOR LON 5 6 0 Incubation time Sec 60 Calibration points 5 Point 1 3 100 0 Main Menu Sec 10 4 Point 2 25 Sec 2145 Point 3 S 3 125 34 4 Factor 10 Calibration curve F10 Calibration points 5 Point 1 Sec 18 4 Point 4 3 0 0 Sec 0 0 Point 5 0 0 Sec 0 0 Press ENTER to save new entry Max Difference 5 Change Yes No Press ESC to cancel Yes Repeat Test FAC 1 1 for all calibration Single test points Change Single test 1 Calibration curve F10 Duplicate test 2 Press ENTER to continue Point 1 100 0 Press ENTER to save new entry Single test Duplicate test Press ESC to cancel Test FAC Test FAC Max Diff
6. Buffer ml Dilution factor 1 10 0 2 1 8 1 1 20 1 0 of 1 10 1 0 0 5 1 40 1 0 of 1 20 1 0 0 25 1 80 1 0 of 1 40 1 0 0 125 1 160 1 0 of 1 80 1 0 0 0625 A 7 Intrinsic Factors VIII IX XI und XII Fast Track Note Use the Multipette See section 5 for information regarding programming Activate the RUN Menu by depressing the lt RUN gt key Select lt 3 gt Start Single Test Program Select lt APTT gt Enter the number of samples rack Enter the Patient ID Allow the APTT reagent to warm to room temperature Warm the CaCl reagent to 37 C Place cuvettes in the sample rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using Tetravettes Prepare 1 5 sample dilutions Dispense 50ul of diluted sample patient sample 1 5 dilutions are prepared using Imidazole buffer in the bottom of each cuvette Add 50 ul of the appropriate Factor Deficient Plasma Close flap remove rack from preparation area and swirl gently 4 5 times Transfer rack into the heated incubation area or into the rotating test positions Add 50ul of APTT reagent to each cuvette Incubate for a minimum of 180 seconds up to a maximum of 300 seconds Press to prepare the Incubation Timers and then press for each activated measuring channel The activated measuring channels are indicated by 1 2 3 or 4 in the bottom line of the Operating Screen Upon completion of incubation timing the correspon
7. Check sample integrity looking for micro clots haemolysis or other irregularities Assure that ratio of anticoagulant to sample is correct full draw Draw a new specimen If erratic results are again obtained inquire about the clinical condition of the patient Results on patients in DIC are characteristically erratic Observe recommended sample storage conditions Sample related No sample added Assure that sample has been added 70 O M V 1 1 2 07 03 30 Kc 49 Amelung Symptoms Possible causes Corrective action No clot formation Sample related Low fibrinogen A deficiency of Fibrinogen will greatly prolong the results of many coagulation tests Reagent related No or incorrect reagent added Assure that correct reagents are being used Analytical error No ball in cuvette Assure that the ball has not fallen out of the cuvette prior to insertion into measuring well Clot formed but not detected Timer does not stop Analytical error Cuvette not seated in well Ball is positioned above the sensor Assure that there are no balls or other obstructing material in the bottom of the well Sample related Clot formed before 4 5 seconds If performing Fibrinogen use next higher dilution To stop the timer insert a new cuvette with ball in the measuring well After 10 seconds lift the cuvette out of the well
8. INR Press ENTER to save new Press ESC to cancel entry value 1 03 PT calculation value calculation 0 time Sec Incbation Single te Calibrati st on Sucve If incorrect values have been entered press Yes lt 1 gt to repeat the data entry routine 46 Point 1 100 0 10 8 Sec Point 2i 25r YE a 215 Seg Point 3 12 5 31 4 Sec PT max 130 With INR calcualtion ISI value e023 Change Yes 1 No 2 O M V 1 1 2 07 03 30 Kc 49 Amelung 5 3 PT activity Flow Chart Y Test PT Incubation time sec Single test Calibration curve Point 1 0 0 0 0 Sec Point 2 0 0 0 0 Sec Point 3 0 0 0 0 Sec PT max 130 Without INR calculation Change Ye i Test PT Single test Change Single test Duplicate test Press enter to continue Single test Duplicate test Test PT Max Difference 10 Press ENTER to save new entry Press ESC to cancel Test PT Incubation time Sec 60 Press ENTER to save new entry Press ESC to cancel Calibration curve Point 1 100 0 Press ENTER to sane new entry Press EXC to cancel Next test or main Menu Calibration curve Calculate INR With INR calcualtion Enter INR Value Without INR calculation Enter
9. MENU gt key see section 3 4 Select lt 3 gt Configuration Menu Enter the password and press ENTER lt gt The default password is 1234 Select 1 Change Routine Program if the Routine program is to be programmed 3 Change single test program if the Single Test Program is to be programmed For Routine Program programming Select all of the tests which will form the Routine Program test group using the appropriate function keys e g lt APTT gt The tests will be processed in the RUN mode in the same order they have been selected Wrong entries can be deleted using the lt DEL gt key If programming is aborted using the lt ESC gt key the test programmed in the original Routine Program will remain active When all tests have been selected press lt gt to return to the Configuration Menu O M V 1 1 2 07 03 30 Main Menu Main Menu Date 1 Jan 2000 1 Time 00 12 2 Configuration menu 3 Print paramters 4 RUN Menu RUN Screen Password Entry Enter password Press ENTER to continue Configuration Menu Configuration Menu Change routine program Change emergency program Change single test prog Delete all programs Change language keypad allal eij Nj e Change password Press ENTER to continue Example Routine Program Tests in Routine program APTT INR EIB T
10. Measurement AD OM ss iscccuesersveaaceenecetuetsaiaeenee tare anesnn nieve 35 3 19 Result QutPp t asia eeren eee ee nee eer 35 3 19 1 Result Output in Test Mode Program sesssssserrsrsssssrerrrrrrrrsssrrrrerren 35 3 19 2 Result Output in Routine Emergency or Single Test ceeeeeeeeeee 35 3 19 3 Result Output to LIS Laboratory Information System eeee 36 3 19 3 1 PC SERIAL Interface Specifications ccccccceeeeeeeeeeeeeeeeeteneeeeeeeees 36 3 19 3 2 Data protocol for the PC SERIAL Interface ccccessseeeesssteeeeeeees 37 4 PROCESSING MODE PROGRAMMING cccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneees 39 4 1 Routine and Single Test Mode Programming ccccceeeeeeeeteeeeeeeeeeeeeeees 39 4 2 Emergency Program Programming ccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 40 5 TEST CONFIGURATION CHANGING CONFIGURATION cccccsseseeeeeeeeeeeeees 43 5 1 Accessing Test Contiquration n anccadicAwl eho desi ao ieee 43 SPAA id Head il erence art A erate nee reer ee RC RRR rR RRR eR ER ERC Re ROC ER 44 Or MAMMA id A activity Flow Chan eree oa re 47 BA RATIO EE E E S esa E 48 5 5 Rato Flow G am cana aaee a aa a anaa ENEA a aA T A aA ENA KA AA EA anne 49 5 6 INR International Normalised Ratio c cccceceeceeeeeeeeeeeeeeeeeeeeeeesseneeeeees 50 Sa INA PIGWEGIANT uachiccsauhices caters E T TA TA S 52 BG APT POR E E tan satau aca oecau
11. Press No lt 2 gt or lt gt to cancel and retain the original Test APTT settings The next test will be displayed ENE cel For single testing select lt 1 gt Single test Cire ge For duplicate testing select lt 2 gt Duplicate test Single test Duplicate test 2 Press lt gt to retain the original settings Press ENTER to continue If duplicate test has been selected enter the maximum permitted difference between duplicates and press lt gt to save the new entry Masa Cache Baca ate ena lt o gt XG Press lt ESC gt to cancel and retain the original settings Tegi APTI The difference will be calculated as follows Press ENTER to save new entry Difference Difference between Measured and Average value 100 Average value Press ESC to cancel Test APTT Enter the incubation time contained in the test application and press lt gt to save the new entry Incubation time Sec z 180 Press lt ESC gt to cancel and retain the original setting Press ENTER to save new entry In conclusion all values will be displayed Press ESC to cancel If the values have been correctly entered complete the entry with No lt 2 gt or lt gt Lali assiseg begit AB T Ter oai uouo The APTT test is configured Incubation time Sec gt 180 All parameters of the following tests are now displayed If there are no tests to follow the Main Menu will
12. a reference plasma dilution Example 25 Enter the clotting time for the second point on the PT calibration curve and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting Example 21 5 seconds O M V 1 1 2 07 03 30 Leese PI Max Difference 5 Press ENTER to save new entry Press ECS to cancel Testi Bed Incubation time Sec 60 ENTER to new entry Press save ESC to Press cancel Calibration curve PT Point 1 ENTER to new entry Press save ESC to Press cancel Calibration Curve PT Point 1 Sec 10 8 ENTER to new entry Press save ESC to Press cancel Calibration curve PT Point 2 sy 900420 ENTER to new entry Press save ESC to Press cancel Calibration curve PT Peo ui titora sec 25 6 ENTER to new entry Press save ESC to Press cancel Enter the third value for the PT calibration curve and press lt gt to save the new value Press lt ESC gt to cancel and retain the original setting The third point is the lowest point in the curve and is a reference plasma dilution Example 12 5 Enter the clotting time fort he third point on the PT calibration curve and press lt gt to save Press lt ESC gt to cancel and retain the original setting The value for point 3 is the one with the longest time value Example 31 4 seconds Enter
13. area 8 Dispense one ball into each cuvette if not using Tetravettes 9 Prepare 1 10 sample dilutions 10 Dispense 50ul of diluted sample patient sample 1 10 dilutions are prepared using Imidazole buffer in the bottom of each cuvette 11 Add 50 ul of the appropriate Factor Deficiency Plasma 12 Close flap remove rack from preparation area and swirl gently 4 5 times 13 Transfer rack into the heated incubation area or into the rotating test positions 14 Incubate for a minimum of 60 seconds up to a maximum of 180 seconds 15 Press to prepare the Incubation Timers and then press for each activated measuring channel The activated measuring channels are indicated by 1 2 3 or 4 in the bottom line of the Operating Screen Upon completion of incubation timing the corresponding READY field will display 16 Upon completion of incubation timing place rack into the rotating test positions and open the flap 17 Press and hold the lt START gt key Using the Multipette dispense 100 pl Thromboplastin the correct order into the cuvettes Start with the measuring channel on the left 1 With the Multipette the timer starts automatically as the reagent is dispensed The timers stop when the samples clot 18 Call up the results and record them See test application O M 07 0 V 1 1 2 3 30 75 Kc 49 Amelung A 6 Extrinsic Factor Standard Curve Dilutions Dilution Reference plasma ml
14. be Single test activated i Change Yes 1 Noj 2 If incorrect values have been entered press Yes lt 1 gt to repeat the data entry routine O M V 1 1 2 53 07 03 30 Ke 49 Amelung 5 9 APTT Flow Chart valid also for TCT ol keene alee es TESE AP eds tile RES Incubation time Sec 180 Single test Change Yes 1 No Test APPT Single test Change Single test Duplicate test Press ENTER to continue Duplicate test Single test Test APPT Max Difference 5 Press ENTER to save new entry Press ESC to cancel Vv Test APTT Incubation time Sec 180 Press ENTER to save new entry Press ESC to cancel Next test or Main Menu 54 bienech O M V 1 1 2 07 03 30 Kc 49 Amelung 5 10 FIB Fibrinogen Before the Fibrinogen test can be configured the concentrations and clotting times must be known for each calibration curve point Between 3 and 9 calibration points may be entered on the KC4A Note contained in the test application Note The following values are only examples and should be replaced by the values The Dilution will be reset to 1 10 when the KC4A is switched on and displayed in the Operating Screen see section 3 16 This value can be modified in the FIB test measuring mode by pressing the lt DILUTION gt key when no measurements are active The
15. instructions for use AMAX Destiny AMAX 200 AMAX 400 KC1A KC4A cy Batch code number System Cleaner Manufactured by Diverse Consumables Use By Date YYYY MM System Cleaner Temperature limits for storage Cuvettes Cuvette Trays System Cleaner By no means operate without the cover plate The cover plate ensures that extraneous light does not cause interference to the photometer AMAX Destiny Do not touch while instrument is in operation May be hazardous to operator May cause damage to instrument Robot Gantry AMAX Destiny AMAX 200 AMAX 400 Position of model serial number label Back of instrument AMAX Destiny AMAX 200 AMAX 400 KC1A KC4A 04 01 21 SI 9 Amelung Haemostasis Instruments SAFETY INSTRUCTIONS Symbol Meaning Used on in COM Port connection AMAX Destiny for keyboard mouse Right hand side of instrument AMAX 200 and printer COM Port connection On back of PC AMAX 400 for keyboard mouse and printer Consumables Use only consumables recommended by Trinity Biotech Plc Operation Manual Reagent Applications Use only reagent applications approved verified and provided by Trinity Biotech Ple Reagent box inserts application sheet and Operation Manual SI 10 04 01 21 Kc 4 Amelung OPERATION MANUAL Software Version 2 3 Instrument manufactured by Trinity Biotech p
16. levels according to the NCCLS EP5 T2 protocol Low Mid High Mean mg dl 104 09 154 10 323 53 Total imprecision CV 3 53 6 21 4 36 Within run imprecision 2 05 2 86 2 12 O M V 1 1 2 07 03 30 biewech 1 4 5 Precision Factor X Ke 49 Amelung The imprecision was evaluated at three levels according to the NCCLS EP5 T2 protocol Mean mg dl Total imprecision CV Within run imprecision 1 4 6 Precision Factor IX Low Mid High 31 57 102 8 28 5 71 5 22 2 63 2 22 2 20 The imprecision was evaluated at three levels according to the NCCLS EP5 T2 protocol Mean mg dl Total imprecision CV Within run imprecision Low Mid High 24 49 98 5 88 6 89 4 06 3 96 4 04 2 54 O M V 1 1 2 07 03 30 bienech Kc 4 Amelung 1 5 Front View KC4A Amelung Figure 1 2 Item Function or Description 1 Preparation area Used for preparing samples before the incubation step 2 Sample holders Used for transferring cuvettes from preparation area to reaction incubation wells and rotating test positions 3 Reagent warming wells 5 Three 15 mm and two 11 mm heated used to 4 Pipette Tubes 2 5 Reaction incubation wells 8 6 Rotating test positions 4 7 Display Screen O M V 1 1 2 07 03 30 warm reagents Used to store and preheat the pipettes when not in use Heated wells used for incubation of sample and first reagent Positions where start reagent is added and the clotting time is mea
17. lower part of the Operation Screen and which contains a sample to be tested O M V 1 1 2 07 03 30 33 Kc 49 Amelung Press the Channel timer key The Start Inc field will display for the corresponding channels At the same time each of these channels will begin the incubation countdown starting with the incubation time defined for this test Exception In measuring program Test Mode the incubation time will counted upwards When the desired incubation time has been reached press the lt READY gt key and then the Channel Timer key to activate the channel When 5 seconds of the incubation time remain an audible beep will sound The flag will be moved from the Start Inc field to the Ready field When the Ready field is so flagged that channel may be started Note Each channel may be started without an incubation time However the operator should adhere to the manufacturer s recommendations for the test procedure To override or interrupt the incubation time press the lt READY gt key and then the corresponding Channel Timer o key The selection of the lt READY gt key will be confirmed with READY in the bottom left of the Operating Screen 3 17 2 Testing 1 2 34 Install an appropriately sized tip onto the pipette Mix particulate reagent by covering the tube with Parafilm and inverting gently Do not shake Many coagulation reagents are mixtures of lipids whic
18. no further than 1 5 m 5 feet from an electrical outlet A total of two 2 outlets will be required for the AMAX Destiny and AMAX 200 A total of three 3 outlets will be required for the AMAX 400 One 1 outlet is required for KC1A and KC4A The instrument should not be operated from an extension cord that does not employ protective grounding The electrical outlet line should not be shared with large power consuming devices which are frequently turned on and off e g centrifuges air conditioners or refrigerators When these types of device power on and off there may be enough voltage drop on the line to interfere with proper functioning of the instrument W 04 01 21 bieyech Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 3 Electrical Requirements and Precautions 1 The instrument is factory equipped with a three pronged grounding plug designed to be connected with a matching three pronged receptacle This procedure is in accordance with the National Electrical Code and other applicable ordinances for this type of installation Under no circumstances should it be connected to an ungrounded two pronged plug 2 Do NOT use an extension cord not equipped to provide protective grounding Prior to connecting to the electrical outlet check to ensure that the instrument operating voltage 100 240 VAC 50 Hz 60 Hz 180 265 V or 90 132 V corresponds to the local line voltage 4 Itis recommended that a Trinity Biotech servic
19. ola EEEE EEEE 53 5 9 APTT Flow Chart valid also for TCT s cccc eecctcennceeeeeecenitecmceeacepenenttennceeede 54 5 10 FIB CPIDMMOGOI dinnsear 55 Se a A PIB FIGW Ghali EEE E TA TAE A A TA 57 5 12 FAC Factors FAC inverse Calibration Curve 0 0eeeeeeeeeeeeeeees 58 5 13 FAC Factors Flow GNM eaves ttt ta cecauneriee a eer entenmeanst cee ueeemeetcceerentaae 61 6 QUALITY CONT ROM wissivcicivicsccicccccsccccvcctccccvccscccsvcctecesveescaesvestenesvtesetesvsstunesvieeeteeeee 63 i MAINTENANGE ATT 65 8 TROUBLESHOOTING rsccccccvcccveccvecevecsucvavccavetewccnntvavecaucccwccneccawecueceawccnecuawecnececueeacs 67 8 1 Troubleshooting Flow Chatt ccccccccccceccececeeeeeeeeeeeeeceenneeeeeeeeesteeeenneeeeees 67 8 2 Troubleshooting Procedures Table ccccceeeeesseeceeceeeeeeeeeeeeeenseeeeees 67 A APPENDIX iscscenasnoterneeset onesie sna nae rade siha sanesa snes eee sas 73 Pols MINTR IB ASU Title a a 73 A23 APTT FastTrack ssena neni la Maca Nanhai a Nem CaN lacy tg 73 FG SAM ral e c a fe 7 Cae a ee ee 74 A 4 FIB Calilbration Curve DilUtions ccccccccccccccccccceceeeeeeeeeeeeeeeceeeeeeeeeeeeeeeeess 75 A 5 Extrinsic Factors Il V Vil und X Fast Track ccccccccceccseeeeeseeeseseeeeeseeeeeees 75 A 6 Extrinsic Factor Standard Curve Dilutions ccc ccccccccccceeeeeeeeeeeeeeeeeeeeeeeees 76 A 7 Intrinsic Factors VIII IX XI und XII Fast Track cecen 76 A 8 Intrinsic Factor Standa
20. sequence Follow manufacturer s instructions O M V 1 1 2 07 03 30 69 Kc 49 Amelung Symptoms Possible causes Corrective action Controls may be in or out of range Erratic within run test results Analytical error Imprecision in manual pipetting of sample and reagent Perform pipette maintenance A pipette Operating Manual is included in the box of the automatic pipette provided with the KC4A Practice pipetting technique Refer to the pipetting section for guidance Incorrect dispense position Consistent location for reagent dispense is important Refer to Pipetting section for guidance Failure to mix particulate reagent prior to use Cover top of tube with cap or Parafilm and invert gently to mix Failure to mix sample and first reagent After dispense of sample and reagent pick the cuvette up and swirl gently 5 6 times to evenly disperse the mixture in the bottom of the cuvette Reagent related Inconsistent or inaccurate reconstitution of reagent or control material Reconstitute new reagent and or control material Reagent related Reagent deterioration caused by extended heating in reagent well Remove reagent from instrument at the completion of testing Reagent related Reagent concentration caused by evaporation Reagents should be capped when not in use Sample related Improper specimen collection and handling
21. the instrument ON OFF Serial interface RS232 Used for transferring data to the LIS Laboratory Information System O M V 1 1 2 11 07 03 30 biach Kc 49 Amelung 1 8 Multipette Figure 1 5 Combitip Figure 1 6 Multipette Item Function Description 1 Combitip Tip used on the Multipette 2 Combitip aspiration dispense cone Portion of the tip that aspirates reagent 3 Combitip smallest pipetting volume 4 Max filling volume for the Combitip 5 Locking Clamp Used to firmly clamp the Combitip in the Multipipette 6 Filling lever The Combitip is filled by sliding the lever upward 7 Dispense lever The volume is dispensed by pressing the dispense lever down until it stops 8 Volume selection dial Determines pipetting volume setting 1 5 multiplied by the minimum pipetting volume of the Combitip 1 25 ml or 2 5 ml pipette tips 9 Start cable Connects pipette to instrument Detailed instructions for the use of the Multipipette can be found in the Multipipette instruction booklet Combitip and Multipette are trademarks registered by Eppendorf AG Hamburg Germany 12 O M V 1 1 2 07 03 30 bieyech Kc 49 Amelung 1 9 Thermal Printer Optional FRONT Paper cower window Paper cover Fs N Power Setioh Poraar lamp BACK Serial input Faral input Power tippt Cininecior peo Figure 1 7 Ground sorew More detailed description and instructions for the use of the Thermal Print
22. 1 With the Multipette the timer starts automatically as the reagent is dispensed The timers stop when the samples clot 16 Call up the results and record them ONOoahtwnn Ab 4 ono See test application A 2 APTT Fast Track Note Use the Multipette See section 5 for information regarding programming Activate the RUN Menu by depressing the lt RUN gt key Select lt 3 gt Start Single Test Program Select lt APTT gt Enter the number of samples rack Enter the Patient ID Allow the APTT reagent to warm to room temperature Warm the CaCl reagent to 37 C Place cuvettes in the sample rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using Tetravettes 10 Dispense 50ul of sample into bottom of each cuvette 11 Close flap remove rack from preparation area and swirl gently 4 5 times 12 Transfer rack into the heated incubation area or into the rotating test positions O M V 1 1 2 07 03 30 See OL Slee o 73 Kc 49 Amelung 13 Add 50ul of APTT reagent to each cuvette 14 Incubate for a minimum of 180 seconds up to a maximum of 300 seconds 15 Press to prepare the Incubation Timers and then press O for each activated measuring channel The activated measuring channels are indicated by 1 2 3 or 4 in the bottom line of the Operating Screen Upon completion of incubation timing the corresponding READY field will display 16 Upon compl
23. Amelung Haemostasis Instruments SAFETY INSTRUCTIONS Table of Contents SI 0 Introduction to Safety INStrUCtiONS ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeees 1 SI 1 Installation AMAX series ccccccceeeeteeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeseeeenneeeeeneees 1 SI 2 Location Requirements sesiseccictcacteereserinatucatndtasmcutvncncccacecensceapeiapecstenseusneve 2 SI 3 Electrical Requirements and PreCautiOns cccccccccceeesseeeeeeeeeeeeeeeeeeeeeees 3 SI 4 Removal of Shipping Safety Clamps AMAX serieS nnsssssssssssssnssnnnns 3 SI 5 Fresh Water and Waste Water Connections AMAX series 4 SI 6 Connection of Power Cables s sssseeeeeeeeeeeeeseeeeeeeeeeeseeeeeeeeeeeeeeeeeseeeeaaes 5 SI 7 POWER OWN sss ciccccusesccesceas sees vars vcsatssuneosestetacnsanceannssanreauseancectnet scent EnA Edn deep teeedentec 6 SI 8 Safely Using the Amelung Instrument eeeceeeeeeeeeeeeeeeeeeeeeeseeeeenes 7 S1 8 1 How to Avoid Danger to Life amp Health of Operators 0 cceecceeeeeeeees 7 SI 8 2 How to Avoid Damage to the Instrument ssseseeessesseernneseeerrrrrrneesssree 7 SI 8 3 Aende A U SE a E aa e 8 SI 8 4 Who May Use the Amelung Haemostasis Instruments eee 8 SI 9 Symbols used on the Amelung Haemostasis Instruments and Consumables eaaa aaciaee cedctccecccesdi Avsee sib dindineeedda eect eee 9 04 01 21 W SI O biach Amelung Haemostasis Instrum
24. ENTER to Save new entry Press ESC to cancel Calibration curve Point 1 Cea amp Press ENTER to save new entry Press ESC to cancel Calibration curve Fig Point 1 Sec A 0 7 8 Press ENTER to save new entry Press ESC to cancel The last point is the point with the smallest value and the longest time O M V 1 1 2 07 03 30 59 FAC Calibration Curve inverse curve Data Entry Enter the FAC calibration reference plasma value and press lt gt to save the new entry Point 1 is the point with the highest and the longest time The value need not be 100 Enter the clotting time in seconds for the first FAC calibration curve point and press lt gt to save the new entry Point 1 is the point with the longest time Press lt ESC gt to cancel and retain the original settings Ke 49 Amelung Calibration curve FAC FOLNE A CR o3 100 0 Press ENTER to save new entry Press ESC to cancel Calibration curve FAC Point 1 Sec 54 6 Press ENTER to Save new entry Press ESC to cancel Repeat the last two actions for all points until all of the defined points have been programmed The last point is the point with the smallest value and the shortest time If an inverse calibration curve FAC has been entered confirm the data entry with key lt 1 gt Yes In conclusion all values will be displayed If all values entered are correct press No
25. ISI Value 0 ISI Value Press ENTER to save new entry Press ESC to cancel 03 Calibration curve PT PT max 130 Press ENTER to save new entry Press ESC to cancel Calibration curve PT Point 1 Sec 12 0 Press ENTER to save new enrtry Press ESC to cancel Note The flow chart can also be used for NT and TT O M V 1 1 2 07 03 30 bie Ch 47 Ke 49 Amelung 5 4 RATIO Note Depending on the keypad settings see section 3 5 5 the tests PT and RATIO or NT and TT may be activated The following values are only example values and should be replaced by the values given in the test application Call up the test configuration and the RATIO test section 5 1 Following will be displayed on the screen Test RALLI Select Yes lt 1 gt to change the settings rere tainai cnactcicdceessnenetnetnetnee Incubation time sec 60 Press No lt 2 gt or lt gt to retain the original settings The Mean Normal value 12 8 next test will be displayed for configuration Single test Change Yes 1 No 2 Test RATIO For single testing select lt 1 gt Single test For duplicate processing select lt 2 gt Duplicate test Single test Press lt gt to cancel and retain original setting Se a Single test Duplicate test 2 Press ENTER to continue If duplicate test has been selected enter the maximum d
26. TRINITY BIOTECH SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE 06 02 01 biS lech Kc 49 Amelung T INTRODUC TION err rra rarae arrar r er a haa eee teed ence vans waae taeew ert ieai Ebrar kiment 3 iss ER acate c10 RO ETS eE E reer E E T 3 12 Principle Ol Op rati Nimiiro iriia a 3 1 3 Instrument Specifications aie ieee eee nieces ee rare ence he tee eee ee eee vee eee Soe 4 1 4 Performance Characteristics w o cston eae aa ta ieee eae 5 1 4 1 COMO LAUION RAEE oe Roe a ok Seer eat A hes E eee 5 1 4 2 Precision Prothrombin Time PT senesced event cece dicsertserd eet eser tarde vseeiecns 6 1 4 3 Precision Activated Partial Thromboplastin Time APTT eee 7 1 4 4 Precision FIDMNOOG Mictied vcrictiawievi atenihiiaides Aversecheliieedtenietiela es Ennn EEEa 7 1 4 5 Precision FACtOn X ezeceicie 2es iets eid eet oe eed pete ee 8 1 4 6 Precision Factor DC snes i taser retet tetas a cieata a sicera cpt planta de acca a adel 8 1 5 Front View KC4A Amelung eaceectesescacces vstececeseasteudiceheseccetaves Sieacder veeaean ganas 9 MG NR CY T 1e EEE A EE edewbetedecvestedenestedecventedeoreuledeoventedentebsdecveutiteeuouts 10 ke Back OW stasis tee eae nn ee ea ee ea ea ea ia ea ee eee 11 S INMGIL Bete sien taraentantoalhetnta stati Miata toi Maa a a Aetna 12 1 9 Thermal Printer Optional ic iccccerscacdeec res deravsaniec
27. Z Press ENTER to save new entry Press ESC to cancel 39 For Single Test Program programming Using the appropriate function keys e g lt APTT gt select all of the tests which should be available in the Single Test Program mode Wrong entries can be deleted using the lt DEL gt key If programming is aborted using the lt ESC gt key the test programmed in the original Single Test Program will remain active When all tests have been selected press lt gt to return to the Configuration Menu If the Configuration Menu is exited using the lt gt key all of the programmed tests and their parameters will be displayed in sequence Test parameters can be entered or changed during this sequence section 5 Note The test parameters will always be displayed when the Configuration Menu is exited if at least one of the three menus Change xxx program is selected 4 2 Kc 49 Amelung Example Single Test Program Tests in Routine program APTT FIB TZ INR Press ENTER to save new entry Press ESC to cancel Configuration Menu Configuration Menu Change routine program Change emergency program Change single test prog Delete all programs Change language keypad D f a el wi wolfe Change password Press enter to continue Emergency Program Programming Programming the Emergency program defines which tests will be processed
28. agent defective due to mishandling in shipping or storage First use of reagent in this shipment Temperature of storage area appropriate Reagent related Reagent deteriorated Do not use reagent beyond stated reconstituted stability time or beyond expiration date of un reconstituted reagent Reagent related Reagent deteriorated because of extended warming in reagent well Do not store reagent on instrument At the completion of testing remove reagent from instrument cap and store according to the manufacturer s instructions Reagent related Reagent contaminated Avoid contact of pipette tips with previously pipetted sample or reagent Control related Deteriorated or contaminated control material Prepare fresh controls Incorrectly reconstituted control material s Reconstitute according to the manufacturer s instructions Use only fresh deionised water for reconstitution Analytical error Incorrect incubation time Follow manufacturer s instructions Analytical error Incorrect reagent temperature 15 mm tube must be used No more than 3 5 ml of reagent should be placed in tube Allow 15 20 minutes for reagent to come to temperature in the reagent well Some reagents Thrombin Reagent for Fibrinogen should not be warmed but must be equilibrated to room temperature prior to use Follow reagent manufacturer s instructions Analytical error Incorrect testing
29. alues will be displayed If the values have been correctly entered complete the entry with No lt 2 gt or lt gt The INR test is configured All parameters of the following tests are now displayed If there are no tests to follow the Main Menu will be activated If incorrect values have been entered press Yes lt 1 gt to repeat the data entry routine Tests INR Mean normal value 12 8 TSI Value voll 013 p SSeS 5 Press ENTER to save new entry Press ESC to cancel Incubation time Sec 60 Mean normal value 12 8 ISI Value 10 33 Single test Modify Yes 1 No 2 The KC4A calculates the INR automatically using the Mean normal value and the specific ISI value entered for the thromboplastin reagent in use Note Before values are entered a mean normal value should be determined for the specific lot number of the thromboplastin being used Because the mean normal value is dependant on the patient population the laboratory and the thromboplastin reagent formulation being used the mean normal value should be determined for the specific patient population laboratory reagent formulation combination For a correct INR calculation the geometric mean of the normal patient population should be determined When the geometric mean has been determined it can be programmed into the KC4A coagulation analyzer O M V 1 1 2 07 03 30 51 5 7 INR Flow Chart Test INR I
30. asuring ch 1 is complete time 15 1s 1 10 1 10 active measuring channels with test allocation e g two tests in duplicate displayed two different test in duplicate 3 16 3 Operating Screen in Test Mode left Program Test Mode Test Mode T 37 3C right Measuring block temperature in C poet bow 1 2 3 4 Measuring channels 1 through 4 Incubation time display in seconds Inc time 14 0 0 0 l hie weet teal 0 0l 0 0012 3 0 0 Measuring time display in seconds S T Incubation ch 1 is running since 14s art LC f Measuring ch 2 can be started Ready xxx ke ISTOP v Measuring channel 3 running since 12 3s STOP Measuring on ch 4 was interrupted i 4 using the STOP key Test Mode all 4 measuring channels are always active Note In the bottom left of the Operating Screen the action selected using the lt START gt lt gt or lt STOP gt keys will be displayed see section 3 17 3 17 Sample Processing 3 17 1 Starting Incubation Time 1 After the measuring program has been selected the Operating Screen will be displayed With the transfer of the first rack to the rotating wells press the Incubation timer The bottom left of the Operating screen will display START Inc confirming that the incubation procedure has been initiated 2 Start the incubation timers for each channel which is activated in the
31. aused to the KC4A O M V 1 1 2 07 03 30 16 Kc 49 Amelung 2 5 Preliminary Check of Instrument Performance The preliminary function checks of instrument operation should be performed prior to using the instrument This preliminary function check is to ensure that the instrument is functioning properly prior to reporting patient results 1 Connect the power supply to the POWER SUPPLY socket on the back of the instrument DC6 5V 2A Connect the power supply cable to the power supply and plug the power cable into the electrical supply socket A green light will shine on the power supply 2 Connect the Multipette Starter cables into the corresponding sockets PIPETTES on the back of the KC4A instrument making sure that the Multipette locking mechanism is securely seated Note To protect the instrument from static electrical disturbance some of the connection sockets have protection caps Please remove these caps before connecting the peripheral equipment 3 Ifthe optional printer is being used connect the printer SERIAL input connector with the printer port PRINTER on the KC4A Connect the printer to the mains supply circuit by connecting the POWER SUPPLY PRINTER socket on the KC4A to the DC6 5V 2A socket on the printer Switch the printer on by sliding the POWER switch to 1 Note In order to speed up the warming of the KC4A thermostatically controlled measuring block the
32. be re entered O M V 1 1 2 07 03 30 20 Kc 49 Amelung 3 5 Configuration Menu Functions The configuration menu is selected from the Main Menu see section 3 4 In the Main Menu press 3 Configuration Menu The Configuration Menu is protected from access by unauthorised personnel by a 4 digit password The default password is 1234 Enter the password and press the lt gt key Incorrect entries can be deleted using the lt DEL gt key The Configuration Menu will be displayed Configuration Change routine program Change emergency program Change single test prog Delete all programs Change language keypad Alal Bl WI MIT Change password Press ENTER to continue Configuration Menu 1 Change Routine Program see also section 4 1 This function allows the operator to select the tests available to be run in the Routine Program The tests are selected by pressing keys INR APTT FIB etc and confirming with lt gt Incorrect entries may be corrected by pressing the lt DEL gt key Terminating is possible with lt ESC gt Upon termination the previously set values will remain valid In this program the analyzer will allow a sequential operation of tests Batch mode 2 Change Emergency Program see also section 4 2 This function allows the operator to select the tests available to be run in the Emergency Program The tests are se
33. bitip until it clicks into position Be sure the Combitip plunger is fully inserted into the barrel before attaching it to the Multipette Be sure the filling lever is completely down and then lower the locking clamp to secure the Combitip in place O M V 1 1 2 27 07 03 30 biS lech Ke 49 Amelung Verify that the volume selection dial is set to dispense the correct volume Immerse the Combitip cone into the liquid Fill by slowly sliding the filling lever upward Wipe the Combitip cone with a lint free tissue Follow the guidelines for correct dispense positions described in the following sections 3 12 To dispense the Sample Sample should be dispensed to the 12 o clock position of the cuvette See diagram Aim the pipette to the 12 o clock position Position the tip approximately 3 4 mm above the bottom of the cuvette Depress the pipettor button to the first stop and hold for 1 2 seconds to allow the residual contents of the tip to collect at the bottom of the tip Press the button to the second stop This will deliver any residual sample into the cuvette To avoid bubbling and splattering the tip should not be placed so Close to the bottom that at the completion of pipetting the tip is submersed in the dispensed sample An alternative method is to touch the tip to the cuvette sidewall approximately 3 4 mm above the bottom of the cuvette and then depress the button slowly to the first stop Wait 1 2 seconds and
34. can be corrosive and any spillage into the reagent incubation well should be cleaned up immediately All sample spills should be considered to have created a potentially biohazardous environment and should be cleaned up immediately using appropriate safeguards to avoid personal contamination If decontamination is required wipe area with a paper towel moistened with a mild disinfectant Any balls that inadvertently find their way into the bottom of any of the wells can be removed using a magnet O M V 1 1 2 07 03 30 65 Kc 42 Amelung 8 Troubleshooting 8 1 Troubleshooting Flow Chart Sample Preanalytical Analytical related error error 8 2 Unexpected results Reagent related Control related Troubleshooting Procedures Table Symptoms Possible causes Corrective action After pressing On Off the display is empty measurement well is not rotating Instrument Error KC4A not connected to power supply or power supply not connected to outlet Assure that the connecting cable is seated firmly in the power supply socket Assure that the power supply cord is connected to the appropriate outlet After pressing On Off temperature fails to stabilize at 37 3 C measurement well is rotating Instrument Error Non functional sensor or thermostat overheating Place approximately 3 ml water into a 15 mm test tube and place it in one of the reagent warming w
35. cluding error values e g values exceeding the max CV Key lt 5 gt Use this selection to enable the transfer excluding error values e g values exceeding the maximum CV The data transfer will be automatically performed at the completion of measurement and need not be manually activated If the KC4A is not connected an LIS Keys lt 4 gt and lt 5 gt have no function and any selection may be made Printer installed When the printer is correctly installed switched on and on line the box will display YES If NO is displayed the printer is either switched off is off line or the data line is incorrectly connected 3 8 Reagent Handling Figure 3 1 Reagents for the appropriate test are prepared according to the manufacturer s instructions Refer to the manufacturer s reagent application for specific instructions on preparation and handling of reagents Any reagent requiring pre heating should be placed into a 15 mm tube and inserted into the reagent incubation well The fluid level in the tube should not be above the top edge of the incubation well A minimum of 15 minutes will be required to warm reagent to 37 3 C 0 5 C Note If reagents are taken directly out of the refrigerator they will need longer to equilibrate All reagents should be used before the end of the manufacturer s recommended expiry date Do not place open reagent vials on the instrument 24 O M V 1 1 2 07 03 30 biey
36. cturer s instructions Centrifuge immediately Centrifuge at correct RCF for correct time interval Store no longer than 4 hours at room temperature or refrigerated temperatures Pre Analytical error Contact with glass Transfer plasma to plastic storage tube using plastic transfer pipettes Sample related Loss of Factors V and VIII Avoid heating at 37 C for longer than 5 minutes Controls out of range Unexpected results Sample related Incorrect volume being used Follow manufacturer s instructions Reagent related Contaminated reagents Reconstitute new reagent or open new bottle Reagent related Wrong reagent being used Follow manufacturer s instructions Reagent related Incorrect volume of reagent being used Follow manufacturer s instructions Reagent related Reconstitution with incorrect diluent volume Follow manufacturer s instructions 68 O M V 1 1 2 07 03 30 Kc 42 Amelung Symptoms Possible causes Corrective action Controls out of range Unexpected results Reagent related Reconstitution with other than the recommended diluent Follow manufacturer s instructions Reagent related New lot number of reagent with different reactivity Lot to lot variation in reagent reactivity is not unusual Re verify reference range Prepare new reference curves as appropriate Reagent related Re
37. ding READY field will display 18 Upon completion of incubation timing place rack into the rotating test positions and open the flap 19 Press and hold the lt STARTS gt key Using the Multipette dispense 50 ul CaCl in the correct order into the cuvettes Start with the measuring channel on the left 1 With the Multipette the timer starts automatically as the CACI reagent is dispensed The timers stop when the samples clot 20 Call up the results and record them Se ee a es Oe Ne kkk N Oo fF W PD See test application 76 O M V 1 1 2 07 03 30 Kc 42 Amelung A 8 Intrinsic Factor Standard Curve Dilutions Dilution Reference Plasma ml Buffer ml Dilution factor 1 5 0 4 1 6 1 1 10 1 0 of 1 5 1 0 0 5 1 20 1 0 of 1 10 1 0 0 25 1 40 1 0 of 1 20 1 0 0 125 1 80 1 0 of 1 40 1 0 0 0625 O M V 1 1 2 07 03 30 bi w h 77
38. e lt RUN gt or lt MENU gt keys 3 7 Printer Menu Functions The Printer Menu is activated by selecting the lt Printer gt key Selection is only possible when the measuring mode is not active or when no other actions have been activated The currently selected options are flagged with Data report Print test page 1 Enable printout cas Disable printout 3 Printout incl error val e Printout excl error val 5 Printer installed Ja Press ENTER to continue Em Data Report Key lt 1 gt Using this selection when the optional printer is connected a test text will be printed The printer is correctly connected if this text is readable Key lt 2 gt Using this selection results will be automatically printed when the printer is correctly connected The result display on the KC4A screen will be deactivated This selection must be made every time the KC4A instrument is powered up During active operation this function can only be selected when the word Yes is displayed in the box beside the question Printer installed See below Key lt 3 gt Use this selection to disable the automatic printout Result data will be displayed on the screen Deferred printing of results is no longer possible O M V 1 1 2 23 07 03 30 Kc 49 Amelung Key lt 4 gt If the KC4A is connected online to a Laboratory Information System LIS see section 3 18 3 use this selection to enable the transfer of data in
39. e representative performs any repair work other than routine maintenance and minor adjustments 5 Instrument safety is uncertain if the instrument is not operated according to the instructions in the Operation Manual SI 4 Removal of Shipping Safety Clamps AMAX series WARNING 1 The cable binders resp tapes must be removed from the robot arm X and Y axis drive belts prior to system activation WARNING 2 The protection on the tip of the probe be removed prior to system activation WARNING 3 Shipping safety clamps holding the probe must be removed prior to system activation 04 01 21 W Sl 3 biach Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 5 Fresh Water and Waste Water Connections AMAX series Fresh water for probe rinsing and washing is supplied from a 2 liter container AMAX Destiny 21 liter container AMAX 200 AMAX 400 1 Fill the fresh water container to the Max Level line with deionized water Optimum performance will be obtained if the water is allowed to degas prior to installing on the instrument Degassing is most easily accomplished by allowing the filled container to sit for 8 12 hours prior to installing on the instrument 2 AMAX Destiny The fresh water A and waste water B reservoirs are located on the left side when facing the instrument front of the AMAX Destiny a Place the fresh water in the back position and the waste contain
40. eceecverccvantevadeucdeeacventese eaguces 13 A MIN Pe Pa LOIN E eace auc coca scat uate cde T 15 Ae UMMM ACH BNC E eae lca ne ee ee ee en cen a uiiee eeiee Deeul wet ee enon 15 2 2 SOLAN 2 10 O44 RRO re en no rT ee ete ea nee ee Ree ve ere en eee 15 2 3 Location Requirements cataners eater eaters ote eae 16 2 4 Electrical Requirements and Precautions eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 16 2 5 Preliminary Check of Instrument Performance cccceeeeeeeeeeeeeeeeeeees 17 3 GENERAL ORERA TION ei cisisesctitntainubeticbiuebsinduiatabsbeuets dvisincetenass onlaindebsdnonsenedecsivisiads 19 3 1 KC4A Programs and their Function Secesised foes onde luce acisad soon cod doe ee ieee ons ed 19 3 2 Switching on the KC4A Coagulation AnalyZev c ccceeeeeeeeeeeeeenteeeeees 19 3 3 Temperature Indicator SCre M ce eeeeeeescceeeeeeeeeeeeeeaeeeeeeeeeeeeensesneeeeeeees 20 3 4 Main Menu Functions steed sae a SO Sa i a i aka i Leela 20 3 5 Configuration Menu FUNCHONS sseisccseteewcsretesnsccedeceeneeOerneoselveneeeeteswesceteeeeted 21 3 6 Run Menu Functions ccccceeeseee sees eeeeeeeeseeeeeeeseeeeeseseeeseeeseesseeeseeeees 23 36 R n Menu FUNnCHONS aiwcicoiocio oon aol ocis ion ae onan ool one lee olan ame 23 S20 Printer MONI FUNCION Sierstenen e occ sed dns envensunsces 23 O26 REAGSIMU FIG IN ae AEA ee ee sp ET 24 3 9 C vettePreparati N si cntecaneeice nck caren naar ca amicus A a Nam
41. ech 3 9 Cuvette Preparation ATTENTION The cuvettes are disposable and should not under any circumstances be reused Amelung 8 ATTENTION Used cuvettes are potentially biohazardous PON Handle according to laboratory safety regulations for disposal of biohazardous DQ materials Unused cuvettes are not biohazardous ATTENTION After the cuvette carton has been opened the cuvettes and balls should be protected from dust humidity and any other dirt and should be stored according the recommended storage conditions printed on the cuvette package Figure 3 2 In KC4A preparation area twelve 12 unheated cuvette positions are available Three 3 sample holders each containing four 4 cuvettes may be positioned there Place one Tetravette in the sample holder see figure 3 2 and remove the paper ball retainer Unpacked cuvettes bulk ware may also be placed in the preparation area positions The ball is then added using the ball dispenser ATTENTION The operator must check that every cuvette positioned in the instrument contains a ball O M V 1 1 2 25 07 03 30 biS ECCh Kc 49 Amelung Place the Tetravettes or Microcuvettes in the preparation positions Up to twelve 12 cuvettes can be positioned in the instrument at one time The exact size and surface quality of the cuvettes is critical to the proper performance of testing Absolute cleanl
42. ed 26 3 If value 2 missing 27 i will be filled with X 28 m i 29 10 0 1 0 0 0 OJO Blank __ Space _ 30 31 1 i 32 2 Right justfied 33 i 34 o i 35 0 0 1 01 01 0 00 Blank Space left justified 38 0 0 1 0 010 0 0 Blank space 39 0 1 0 0 0 1 0 1 E With error E 0 01100 0 0 0 no error Blank 40 0 0 0 0 1 1 0 1 CR 7 Carriage return 41 0 0 0 0 1 0 11 0 LF LF Line feed 42 0 0 0 0 0 0 1 1 ETX ETX End of text O M V 1 1 2 07 03 30 Example for program A P T T APTT P T PT R A T 1 O RATIO When a PT NT o TT Test with INR is performed the complete data protocol will be transmitted twice The first time for the PT NT or TT Test The second time for the INR Test Example of value and result 1 2 3 12 3 1 2 3 4 123 4 1 2 3 4 12 34 1 00 100 Example of unit G Q Grams per Litre S s Seconds 37 Kc 49 Amelung 4 Processing Mode Programming 4 1 Routine and Single Test Mode Programming Programming the Routine Program defines the tests which are to be performed in the Routine Program mode section 3 1 Programming the Single Test Program defines which tests can be called up and performed in the Single Test Program mode section 3 1 The programming method for both the Routine and Single Test Program is the same Activate the Main Menu using the lt
43. ells Insert a thermometer in the reagent tube Observe temperature after a 10 15 minute equilibration period Additional information can be received from your Trinity Biotech Instrument Service Provider O M V 1 1 2 07 03 30 Ke 49 Amelung Symptoms Possible causes Corrective action Controls are in range Unexpected results on patient samples Pre Analytical error Overfill or under fill of collection tube Full draw in commercial vacuum tubes assures correct blood anticoagulant ratio Pre Analytical error Incorrect volume type e g EDTA heparin concentration or lack of anticoagulant Use anticoagulant as recommended by the reagent manufacturer Pre Analytical error Ratio of anticoagulant to blood is inappropriate Failure to correct citrate volume for patients with high gt 55 or low lt 21 haematocrit Pre Analytical error Clotted specimen Testing should never be performed on specimens containing micro or macro clots Pre Analytical error Inadequate or too vigorous mixing of specimen Invert gently to mix well without mechanical trauma Pre Analytical error Contamination with heparin Do not draw blood from a heparin lock or any other heparinized line Pre Analytical error Delay in transporting or processing or the use of nonstandardized procedures for transporting processing storing or testing the specimen Follow manufa
44. ended dispense position After sample has been dispensed close the Plexiglas flap pick the cuvette rack up and swirl gently to evenly disperse the sample over the bottom of the cuvettes Place the rack with cuvettes in the rotating test positions ensuring that the cuvettes are pressed firmly down to the bottom Two additional racks of cuvettes 4 each may also have samples pipetted and placed in the reaction incubation wells Care must be taken not to over incubate the samples It is advisable to stagger the time interval between the cuvette racks in the heated incubation wells and rotating test positions to prevent over incubation Allow the samples to pre incubate for the recommended time It will take slightly longer a minimum of 120 seconds for a sample that has been stored at refrigerator temperature 2 8 C to reach 37 C than for samples stored at room temperature 18 26 C Several of the coagulation factors Factors V VIII XIII and fibrinogen are labile at 37 C To avoid loss of these factors samples should not be pre incubated longer than 5 minutes Timing is critical in coagulation testing and the reagent manufacturer s guidelines for incubation times should be followed Any particulate reagent must be well mixed prior to use For those tests having more than one reagent all incubations prior to measurement start can be accomplished in the reaction incubation wells Nine o clock is the recommended first reagent dispense pos
45. ents SAFETY INSTRUCTIONS SI 0 Introduction to Safety Instructions This brochure is a listing of general safety procedures which should be implemented when using the following Amelung Haemostasis Instruments KC1A KC4A AMAX Destiny AMAX 200 and AMAX 400 The Amelung Haemostasis Instruments may be used as a coagulation analyzer for the detection of fibrin formation utilizing either mechanical principles ball method only KC instrument line or utilizing mechanical principles photo optical principles chromogenic kinetic enzyme analysis and micro particle agglutination assays on the AMAX series ATTENTION Potential Risk samples may contain micro clots which can lead to the generation of false results In order to reduce the probability of generating such outliers take the necessary precautions when withdrawing blood samples and take into consideration that results in duplicate dramatically reduce outlier rates ATTENTION Use only reagent applications approved verified and provided by Trinity Biotech Plc ATTENTION The Trinity Biotech reagents have been optimized for use on the Amelung Haemostasis Instruments Trinity Biotech recommends the use of these reagents on their haemostasis instruments SI 1 Installation AMAX series A Trinity Biotech authorized representative is responsible for unpacking installing and initial setup of the Amelung Haemostasis Instruments 04 01 21 W Sl 1 biach Amelung Haemostasis I
46. equence section 5 Change language keypad 5 Change password 6 Press ENTER to continue Note The test parameters will always be displayed when the Configuration Menu is exited if at least one of the three menus Change xxx program is selected O M V 1 1 2 41 07 03 30 Kc 49 Amelung 5 Test Configuration Changing Configuration Prerequisite In order for a test to be configured it must have been selected for use in at least one of the processing programs see section 4 If this is not the case insert the test in one of the processing programs Please note that the insertion of a new test in a processing program will deactivate the previous programming The originally programmed test must be reselected by pressing the corresponding function key e g INR In the Routine and Emergency Program the order of entry is important Tests will be processed in the same order that they are entered in these programs Configuring a Test or changing a test configuration In order to change test parameters at least one of the menu options Change Routine Emergency or Single Test Program must be selected from the Configuration Menu section 4 The menu option Change XXX program can be exited using the lt ESC gt key The program retains the original settings The Configuration Menu will be recalled After pressing the lt gt key all of the tests and specific test programming will be displayed in sequence and may be c
47. er can be found in the Thermal Printer instruction booklet O M V 1 1 2 13 07 03 30 biewech Kc 49 Amelung 2 Installation 2 1 Unpacking The KC4A Coagulation Analyzer is shipped in a transport box designed to protect the instrument from damage during shipment If damage is apparent immediately notify the shipping company Note the damage on the shipping bill of lading and notify your Trinity Biotech Sales Representative 2 2 KC4A Startup Kit Carefully remove the instrument and accessories from the transport box Check that the following items have been included gt KC4A gt Power Supply and Power Cable gt Starter Set KC4A Catalogue Description Quantity Z04140 Tetravettes Micro Box with 150 pieces 1 Box 848040 Dust Cover KC4A 1 each 832150 Tubes Glass 14 5x85mm 50 each 832155 Tubes Plastic 14 5x85mm 100 each 838012 Combitip 1 25ml 5 each Additional Products and Consumables Catalogue Item Z09165 Printer DPU 414 30B KC Delta 852015 KCA Series Thermal Printer Paper P02100 KC4A Multipette with Starter Cable 838012 KC4A Combitips 1 25 ml 838025 KC4A Combitips 2 50 ml 838830 Pipette Delta 50 100 200ul 837045 Pipette Tips Yellow 200ul 10 trays 832150 Tubes Glass 14 5x85mm 50 pieces 832155 Tubes Plastic 14 5x85mm 100 pieces Z04140 Tetravettes Micro Box with 150 pieces Z05111 KC Micro Cuvettes wi
48. er in the front position of the holder mounted on the left hand side when facing the instrument front of the instrument b Connect the waste water tubing to the AMAX The waste water connection D is the lower connector c Connect the fresh water tubing to the AMAX The fresh water connection C is the upper connector 3 AMAX 200 AMAX 400 The fresh water and waste water reservoirs are located under the instrument See illustrations below for connectors fresh water in and waste water out respective fresh water sensors and waste water sensors AMAX Destiny AMAX 200 400 Fresh Water Gera 1 Waste out 5 Fresh in 3 Fresh sense 4 Waste sense Fresh water in Waste water container out container WARNING The AMAX Destiny waste water tubing is larger than the fresh water tubing The connectors at the instrument are different DO NOT ATTEMPT TO FORCE THE CONNECTORS Sl 4 W 04 01 21 biach Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 6 Connection of Power Cables WARNING Ensure that ON I OFF 0 switch is set in the OFF position for the Instrument and printer WARNING The Instrument and associated printer should not be placed on the same electrical line as air conditioners refrigerators or centrifuges WARNING Do not connect to an ungrounded two pronged power outlet
49. erence 5 Calibration points 3 Press ENTER to Press ENTER to save new entry save new entry Prees ESC to cancel Press ESC to cancel Test FAC Test FAC Incubation time Sec 60 Factor 10 2 5 7 8 9 10 11 12 Press ENTER to Press ENTER to save new entry save new entry Press ESC to cancel Press ESC to cancel O M V 1 1 2 61 07 03 30 Kc 49 Amelung 6 Quality Control Regularly performed quality control is the best monitor of test performance To assure that control and unknown sample results are evaluated under the same test conditions control material should be included with each run The reagent manufacturer s QC recommendations should be used as a guide for establishing a QC protocol Control results deviating from established ranges are indicative of a system failure and should be investigated immediately The more common sources of error and the corrective action to take are presented in the Troubleshooting section Section 8 O M V 1 1 2 63 07 03 30 Kc 49 7 Amelung 7 Maintenance There is no routine mechanical maintenance associated with the KC4A The KC4A was factory calibrated for rotational speed magnetic sensor strength and temperature General housekeeping is the only maintenance that need be performed with any regularity Occasional cleaning with a damp paper towel is recommended to remove accumulated dust or other material Spills should be cleaned up as they occur Reagents
50. erference in residential areas In this case it is possible that the user may be required to take appropriate action WARNING This instrument is classified as an In Vitro Diagnostics Device SI 8 4 Who May Use the Amelung Haemostasis Instruments The instruments should only be used by trained personnel whose knowledge training and experience guarantees correct handling of the system 1 Operators must have been instructed in the use of the Amelung instruments and must operate exclusively in accordance to the instructions contained in this manual 2 Refer to appropriate sections in this manual for instructions on how to operate the Amelung Haemostasis Instruments WARNING Under no circumstances should any software other than that authorized by Trinity Biotech Plc be installed on the integrated AMAX series PCs WARNING Under no circumstances should any consumables other than that authorized by Trinity Biotech Plc be used on the Amelung Haemostasis Instrument SI 8 W 04 01 21 biAECh Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 9 Symbols used on the Amelung Haemostasis Instruments and Consumables Symbol Meaning Used on in E Dorotre s Cuvette boxes Cuvette Trays Cuvettes amp Balls IVDO In Vitro Diagnostics Device Sp raon Manuais Cuvette boxes Biological risks AMAX Destiny AMAX 200 AMAX 400 Consult
51. etion of incubation timing place rack into the rotating test positions and open the flap 17 Press and hold the lt START gt key Using the Multipette dispense 50 ul CaCl in the correct order into the cuvettes Start with the measuring channel on the left 1 With the Multipette the timer starts automatically as the CACI reagent is dispensed The timers stop when the samples clot 18 Call up the results and record them See test application A 3 FIB Fast Track Note Use the Multipette See section 5 for information regarding programming Activate the RUN Menu by depressing the lt RUN gt key Select lt 3 gt Start Single Test Program Select lt FIB gt Enter the number of samples rack Enter the Patient ID Warm the Thrombin Reagent to room temperature 18 25 C Prepare the 1 10 sample dilutions Place cuvettes in the sample rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using Tetravettes 0 Dispense 100ul of diluted sample patient sample 1 10 dilutions are prepared using Imidazole buffer in the bottom of each cuvette 11 Close flap remove rack from preparation area and swirl gently 4 5 times 12 Transfer rack into the heated incubation area or into the rotating test positions 13 Incubate for a minimum of 60 seconds up to a maximum of 180 seconds 14 Press to prepare the Incubation Timers and then press O for each activated measuring channe
52. evaluation to show equivalence with a commercially available photo optical coagulation analyzer Fibrinogen Factor IX Number 109 Correlation Coefficient 0 930 0 897 Slope 1 067 0 958 Intercept 30 749 3 403 The following linear regression data were obtained in three physician s office laboratories POL during evaluation to show equivalence with manufacturer derived results on the KC4A POL 1 Thromboplastin Time APTT Number 47 44 Correlation Coefficient 0 991 0 960 Slope 0 981 1 066 Intercept 0 492 0 379 POL 2 Thromboplastin Time APTT Number 45 46 Correlation Coefficient 0 989 0 965 Slope 1 019 1 029 Intercept 0 248 1 021 O M V 1 1 2 07 03 30 bi w h Ke 49 Amelung POL 3 Thromboplastin Time APTT Number 52 47 Correlation Coefficient 0 974 0 927 Slope 1 012 0 786 Intercept 0 326 9 470 1 4 2 Precision Prothrombin Time PT Imprecision on the KC4A was evaluated at three levels according to the NCCLS EP5 T2 protocol Low Mid High Mean 13 20 33 53 39 66 Total imprecision CV 2 03 2 50 4 18 Within run imprecision 1 02 1 28 1 53 PT total imprecision was evaluated at three physician s office laboratories at three levels according to the NCCLS EP10 T protocol Within run imprecision n 20 on each level was evaluated at three physician s office laboratories at two levels POL 1 Low Mid High Total Mean 13 1 26 8 42 9 Total Imprecision CV 1 97 1 63 2 47 Within Run Mean 12 7 44 1 Withi
53. g 12s left v Measuring channel 3 can be started Ready kK kK DIRK Measuring channel 2 running since 9 3s v Measuring channel 1 is done Time 14 8s t 1 2 active channels with patient allocation displayed two different patients in e g two patients rack duplicate testing dupli oe 5 p 32 O M V 1 1 2 07 03 30 Kc 49 Amelung 3 16 2 Operating Screen in Emergency Program left patient number Pat ID 123456 Stat right Emergency Program Measuring channels 1 through 4 Incubation time display in seconds Measuring time display in seconds Incubation time is running Measurement can be started or is running Position 1 2 3 4 Inc time 0 0 0 0 eas time 0 0 0 0 0 0 0 0 Stra rt Cig Ready Measurement in complete ATE active measuring channels with test allocation EE aeo EA displayed three different tests in single mode e g three test in Emergency Prog singleton left patient number Pat Nr 123456 Stat right Emergency Program EEEN 1 2 3 4 Measuring channels 1 through 4 Incubation time display in seconds Inc time 0 0 0 3 eas time 15 1 7 4 0 0 0 0 Measuring time display in seconds Seane INE n a Incubation time ch 4 running still 3s Measuring ch 3 can be started Ready Sma AE K v Measuring ch 2 running since 7 4s a D FIB FIB Me
54. h will undergo spatial rearrangement when shaken Aspirate reagent into the pipette tip Dispense one aliquot of reagent into reagent container to prime the pipette tip Press the lt START gt key Dispense reagent just to the right side of the ball and simultaneously press the Specific Channel Key There are two starting methods Automatic recommended and the Manual start method Automatic Start Procedure The KC4A Multipette is recommended for use in the Automatic Start Procedure Assure that the Multipette cable is plugged into the Automatic Pipette socket located on the rear of the KC4A Coagulation Analyzer Up to three pipettes may be installed Press and hold the lt Start gt key during reagent dispense into the measuring channels The reagent is dispensed from left to right starting with Channel 1 Simulateously with the reagent dispense the timers will start counting The next measuring channel to the right will be set for measurement start It will be started simultaneously with the next reagent dispense and the following channel to the right will be set for measurement start If the operator releases the lt START gt key after the reagent is added to the first cuvette it must be pressed before the addition of reagent to each cuvette Confirmation that the lt START gt key has been selected is confirmed by the display Start Meas in the bottom left of the Operating screen Manual Start Procedure The manual start
55. hanged Any changes to the test configuration made here will be valid for all processing programs except the definition single duplicate testing in the Emergency Program section 4 2 max difference entry 5 1 Accessing Test Configuration Press the lt MENUs gt key to activate the Main Menu Tie nee section3 4 00 ee Date 1 Jan 2000 1 Time 0 0 3 12 2 Select lt 3 gt Configuration Menu Configuration menu 3 Print parameters 4 RUN Menu RUN Enter the password i Babee Pye SW Rad go pinnis The default password is 1234 Press the lt gt key Press ENTER to continue Configuration Menu Select one of the menu options S Weeki se PEOST Routine Emergency or Single Test Program using keys Change Emergency program lt 1 gt lt 2 gt or lt 3 gt Change Single test prog Delete all programs Change language keypad Example 3 Change Single Test Program ie ae EA oe Press ENTER to continue DN oy ej wi N rR O M V 1 1 2 07 03 30 43 Abort programming using the lt ESC gt key The original programming will be retained and the Configuration Menu recalled Press the lt gt to exit the Configuration Menu All of the tests which are programmed in at least one of the proceeding programs will be displayed in sequence Tests may now be configured by pressing lt 1 gt Modify Yes The configurat
56. i 25 3 10 Sample PrepalalO tec eden cane cae reine ose cee nne 26 SA1 PUD O UNG e828 se cio ree e iet Socata d aie Co AA e Aae a a NES 27 3 12 To dispense the SAM ple ec ict co tiec occ huccaseebies awcetisec seenueeaseetioecdpensean ae ticecerendere 28 3 13 To Dispense the First ROAGSM sees cctedeewensetesentedwevende era vosesvexeetedeeevaceseneetes 29 3 14 To Dispense the Starting Reagent cccccceeeeeeeeeseeeeeeeeeeeeeeeeeeessneeeeees 30 3 15 Selecting Operating Program and Starting ceeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeees 31 3 15 1 Starting Routine or Single Test Program cccceeceeeseseeeeeeeeeeeeeesneees 31 3 15 2 Activating the Emergency Program cccceeeeeeeeeeeeeeeeeeneeeeeeeeeteeeeeaeees 32 3 15 3 Activating Test Mode Program ccceceeeessssscceeeeeeeeeeeeeeeeeeeeeeeeeenessaaeees 32 3 16 Operating Scree 9 eei a Cer Te 32 07 03 30 O M V 1 1 2 biS lech Ke 49 Amelung 3 16 1 Operating Screen in Routine and Single Test Program ccceeee 32 3 16 2 Operating Screen in Emergency Program cccccceeeeeeeeeeeeeeeeeeeeeeeees 33 3 16 3 Operating Screen in Test Mode ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeeeeeea 33 3 17 Sample Pro essiNg Asc nes heed Eana a tee eer uma ee dere EaR ENE 33 3 17 1 Starting Incubation Time sssssssseeeessseeenrrrreressrerrrrrrrsssrrrrrrrnnnnsssrrnnnn nnne 33 ES Al WY yaa EE Eae EEE E T E T E A 34 3 18 Manual
57. ially disposable gloves which may have been in contact with biological material for example infectious plasma should be changed immediately and disposed of appropriately WARNING Plasma reagents cuvette trays cuvettes and waste water are potentially biohazardous waste D 4 Handle according to laboratory safety regulations for disposal of biohazardous materials WARNING If the Instrument exhibits defects which may cause danger to life and health of patients or operators the system must not be used Breakdowns or defects on the Instrument which have caused damage to a patient or operator have to be immediately referred to the direct supervisor SI 8 2 How to Avoid Damage to the Instrument WARNING Use only original Trinity Biotech accessories WARNING Regard the displayed error messages 7 04 01 21 W S biach Amelung Haemostasis Instruments SAFETY INSTRUCTIONS S1 8 3 Intended Use The Amelung Haemostasis Instruments are intended to be used as a coagulation analyzer for the detection of fibrin formation utilizing either mechanical principles ball method only KC instrument line or utilizing mechanical principles photo optical principles chromogenic kinetic enzyme analysis and micro particle agglutination assays on the AMAX series WARNING This instrument is classified as Class A equipment This equipment can cause radio int
58. ibration points 5 Point 4 G L 0 75 Sec 45 0 Point 5 G L 0 55 Sec 65 0 Max Difference 5 Change Yes 1 No 2 Test FIB Single test Change Single test Duplicate test 2 Press ENTER to continue Single test Duplicate test Max Difference 5 Press ENTER to save new entry Prees ESC to cancel Test FIB Incubation time Sec 60 Press ENTER to save new entry Press ESC to cancel Next test or Main Menu Calibration curve FIB Point 1 Sec 12 5 Press ENTER to save new entry Press ESC to cancel Repeat for all calibration points Calibration curve FIB Point 1 G L 2 20 Press ENTER to save new entry Press ESC to cancel A Test FIB Calibration points 5 Press ENTER to save new entry Press ESC to cancel O M V 1 1 2 07 03 30 Ch 57 Kc 49 Amelung 5 12 FAC Factors FAC inverse Calibration Curve Note Only one factor curve can be entered and stored at any one time Note The following values are only examples and should be replaced by the values contained in the test application Note FAC Instead of a normal factor calibration curve an inverse calibration curve can be entered e g for Protein C or Protein S clotting tests The inverse setting is indicated by the flag after the test code FAC Test FAC Factor 10 Activate the test configu
59. ifference and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting Max Difference 5 Tests RATIO The difference will be calculated as follows Press ENTER to save new entry Difference Difference between Measuring and Average value x100 PERRE EREA R Average value Test RATIO Enter the incubation time defined in the test application Incubation time Sek 60 and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original settings PrEEE ENIE E save new entry Press ESC to cancel Test RATIO Enter the Mean normal value in seconds and press lt gt Mean normal value 12 8 to save the new entry Press lt ESC gt to cancel and retain original settings Press ENTER to save new entry Press ESC to cancel 48 O M V 1 1 2 07 03 30 Kc 49 Amelung In conclusion all values willbe displayed ff Test RATIO If the values have been correctly entered complete the Incubation time Sec 60 entry with No lt 2 gt or lt gt Pane Mamas eee eee The RATIO test is configured All parameters of the following tests are now displayed If there are no tests to follow the Main Menu will be activated Single test Change Yes 1 No 2 If incorrect values have been entered press Yes lt 1 gt to repeat the data entry routine 5 5 Ratio Flow Chart
60. in the Emergency Program section 3 1 Activate the Main Menu using the lt MENUs gt key see section 3 4 Select lt 3 gt Configuration Menu Enter the password and press ENTER lt gt The default password is 1234 Press 2 Change Emergency Program 40 Main Menu Main Menu Date 1 Jan 2000 1 Time 00 12 2 Configuration Menu 3 Print parameters 4 RUN Menu RUN Screen Enter Password Enter password Press ENTER to continue Configuration Menue Configuration Menu Change routine program Change emergency program Change single test prog Delete all programs Change language keypad oflaj esej wll ni re Change password Press enter to continue O M V 1 1 2 07 03 30 Kc 49 Amelung Using the appropriate function keys e g lt INR gt select all of the tests which should be available in the Emergency Program mode The tests will be processed in the RUN mode in the same order they have been selected Wrong entries can be deleted using the lt DEL gt key If programming is aborted using the lt ESC gt key the test programmed in the original Emergency Program will remain active When all tests have been selected press lt gt All tests in the Emergency Program will be processed either in single key 1 or duplicate key 2 Press the lt gt key to retain the current sett
61. iness of cuvettes is mandatory for correct performance The cuvettes are intended as one time use items Tetravettes are cuvettes in group in packs of four Each cuvette contains a stainless steel ball and can be used without any additional preparation The balls in the cuvettes are manufactured from a special stainless steel Purity weight size surface quality and magnetic characteristics of the balls are all critical to the proper performance of testing The balls manufactured by Trinity Biotech have been tested to ensure compatibility with the instrument measurement process and that they are inert when used with plasma and coagulation reagents Rust slight impurities or oil residue can have a deleterious effect on coagulation testing results The balls are also one time use items 3 10 Sample Preparation Plasma samples and reagents are added with appropriate microlitre pipettes Refer to the manufacturer s reagent application to determine the sample and reagent s volume required for each test Pipetting technique is critical to the performance of testing Refer to the Pipetting section for guidelines in proper pipetting technique section 3 11 Although the use of a Multipette will facilitate initiation of measurement timing special pipettes are not required If a Multipette is not available measurement timing can be started using the start button and channel buttons Sample is dispensed into the cuvette Twelve o clock is the recomm
62. ing Note The selection of single or duplicate testing made for tests in the other processing modes are not valid for the Emergency Program see section 5 When duplicate testing has been selected the maximum permitted difference between duplicate measuring times in must be entered Press lt gt to close If the entry is aborted using the lt ESC gt key the currently programmed maximum difference value will be retained The difference is calculated as follows Difference difference between measuring and average value x100 Average Value Example Emergency Program Tests in Emergency program INR ECT Press ENTER to save new entry Press ESC to cancel Singleton or duplicate testing in Emergency program Single test Change Single test 1 Duplicate test 2 Press ENTER to continue Enter difference in Emergency program Max Difference 0 Press ENTER to save new entry Press ESC to cancel Configuration Menu The Configuration Menu will be activated Configuration Menu 5 7 3 Ch Routi Pr f 1 If the Configuration Menu is exited using the lt gt key all poo SS So S oran ange Emergency program 2 of the programmed tests and their parameters will be ER E E wearee 3 displayed in sequence Test parameters can be entered peiste aIr pee ened 7 or changed during this s
63. ing screen see section 3 16 23 Activate all four incubation timers by pressing the Incubation Key and then all four Channel Selection Keys All four incubation timers run backwards from 10 seconds to 0 At 5 and 0 a beep tone will sound The screen display in the Ready field indicates that the incubation time has been completed 24 When all incubation timers display 10 press and hold the lt START gt key Press the dispense lever on the Multipette 4 times Observe that beginning on the left all 4 measuring channels will be activated Release the lt START gt key 25 After at least 10 0 seconds remove the cuvette rack from the rotating test positions Observe that the timers stop and are indicating the elapsed time in seconds and tenths of seconds The in the Ready field will be replaced by 26 If the optional printer is connected after about 1 second the measurement timers will reset to 0 and the patient result protocol will be printed 27 If the printer is not in use not properly connected or not switched on an error message will be displayed Printer error Please check if the printer is properly connected and switched on Otherwise press lt ESCs to switch off the print program The result protocol from the first patient will be displayed on the screen Press lt gt to scroll to the next result protocol Press lt gt to return to the Operating Screen With the com
64. ing number Tests result data will be processed according to the selected replicate configuration i e duplicate or single testing When the processing of the last test in the Test Group is completed select lt gt to exit the Routine Program operation Emergency Program In the Emergency Program several different tests will be allocated to and processed from one patient Tests result data for all tests in the Emergency Program will be processed according to the selected replicate configuration i e duplicate or single testing After all tests have been completed the Emergency Program will be deactivated Test Mode In this program selection defined test will not be processed and no IDs will be allocated Only time measurements are performed No results will be transmitted to the printer or to the LIS Laboratory Information System The measuring channels can be individually activated The incubation timers can be individually activated The incubation timers will start at 0 and be counted upwards by seconds 3 2 Switching on the KC4A Coagulation Analyzer The KC4A Coagualtion Analyzer ON OFF switch is on the back of the instrument see section 1 7 Switch the instrument on The 4 measuring channels will rotate and the display screen will be activated O M V 1 1 2 19 07 03 30 biS lech Kc 49 Amelung 3 3 Temperature Indicator Screen After switching on the KC4A the temperature indicator screen will be displayed until the thermos
65. inue 2 The sample ID can be individually defined Press key lt 2 gt to activate this option Then you will be asked for the sample IDs for the Note first group of samples Requesting the Sample ID The patient ID may have a maximum of 9 digits Then the Operating Screen will be activated Sample measurement can now begin section 3 16 1 Note If the patient ID is to be automatically incremented the number of patients per rack and patient IDs will not be requested It is possible to change this by selecting the corresponding test key e g PT Note only for Routine Program When processing of one for all samples has been completed press the lt gt key to activate the next test programmed in the Routine Program O M V 1 1 2 31 07 03 30 biS lech Kc 49 Amelung 3 15 2 Activating the Emergency Program WA A e Le After selecting the Start Emergency Program saa te es the patient ID will be requested Enter the patient ID and press the lt gt key Entry of up to 9 digits is permitted Press ENTER to Sate new entry The Operating Screen will be activated Requesting patient number In the Operating Screen footer the test to be performed are displayed section 3 16 2 If there are more than 4 measurements to be performed the next ones will be called up when the first measurements have been completed 3 15 3 Activating Test Mode Program After activating the Test Mode the Operati
66. ion description will be described under the corresponding name in the following sections Ke 49 Amelung Tests in Single program INR TCT FTB Press ENTER to save new entry Press ESC to cancel If the parameters are correct press lt gt or lt 2 gt Modify No and the parameters of the next test will be displayed When the last test has been displayed the Main Menu will be displayed The configuration is complete 5 2 PT NT TT PT Thromboplastin Time or Prothrombin time NT Normotest TT Thrombotest The method of configuration of the tests PT NT and TT is the same For example the PT test will be described Note und TT can be activate Dependant on the keypad setting Section 3 5 5 the tests PT and RATIO or NT The following values are only examples The correct values should be taken from the reagent manufacturer s test application Call up the test configuration section 5 1 and test PT Following display will appear on the screen Select YES lt 1 gt to change the settings Select No lt 2 gt or lt gt to retain the original settings The configuration for the next test will be displayed For Singleton testing select lt 1 gt Single Test To perform the test in duplicate select lt 2 gt Duplicate Test If lt gt is selected the original setting will be retained Thrombotest is a trademark registered by Axis Shield PoC as Norway 44 Incubati
67. ition section 3 13 Care must be taken to avoid contact of the reagent pipette tip with previously dispensed sample After addition of reagent close the Plexiglas lid pick up the cuvette rack and swirl gently 5 6 times to mix the reagent and previously pipetted sample The reaction mixture should be evenly dispersed around the channel at the bottom of the cuvette No more cuvettes should be prepared for testing than can be completed within the specified guidelines In most instances addition of a start reagent begins the coagulation process It is important that the Measurement Timer be started simultaneously to the addition of the start reagent in order to ensure accuracy and precision of the assay Test measurement timing can be started either manually using the Channel Key or automatically by using the Multipette fitted with a starter cable Use of a Multipette will ensure that the reagent addition starts measurement timing 26 O M V 1 1 2 07 03 30 Kc 49 Amelung The location of the start reagent dispense is important To ensure that mixing of start reagent with the previously pipetted sample or sample reagent mixture begins immediately the start reagent should be dispensed just to the right side of the ball This is best accomplished by holding the pipette angled obliquely from the right rear side of the cuvette towards the ball position and dispensing the reagent just to the right of the ball Care must be taken to avoid sp
68. l The activated measuring channels are indicated by 1 2 3 or 4 in the bottom line of the Operating Screen Upon completion of incubation timing the corresponding READY field will display 15 Upon completion of incubation timing place rack into the rotating test positions and open the flap 16 Press and hold the lt START gt key Using the Multipette dispense 50 pl Thrombin Reagent in the correct order into the cuvettes Start with the measuring channel on the left 1 With the Multipette the timer starts automatically as the reagent is dispensed The timers stop when the samples clot 17 Call up the results and record them S O0 he OT R NE See test application 74 O M V 1 1 2 07 03 30 Kc 42 Amelung A 4 FIB Calibration Curve Dilutions Dilution Fibrinogen Reference ml Buffer ml Dilution factor 1 7 0 1 0 6 1 43 1 8 0 1 0 7 1 25 1 10 0 1 0 9 1 1 20 0 1 1 9 0 5 1 25 0 1 2 4 0 4 1 30 0 1 2 9 0 33 1 40 0 1 3 9 0 25 A 5 Extrinsic Factors Il V Vil und X Fast Track Note Use the Multipette See section 5 for information regarding programming 1 Activate the RUN Menu by depressing the lt RUN gt key 2 Select lt 3 gt Start Single Test Program 3 Select lt FAC gt 4 Enter the number of samples rack 5 Enter the Patient ID 6 Warm the Thromboplastin reagent to 37 C 7 Place cuvettes in the sample rack positioned in the unheated preparation
69. lashing the reagent out of the cuvette The dispense rate should be of moderate speed and forcefulness 3 11 Pipetting The overall performance of the KC4A Coagulation Analyzer is dependent on the accuracy and precision of pipetting both sample and reagent s Testing can be performed with either standard microlitre pipette s or with the Multipette fitted with a starting cable When the Multipette is used to dispense the final start reagent the timer is automatically started simultaneously with reagent dispense When a standard microlitre pipette is used for addition of the final start reagent the timer is started manually using the Specific Channel Key Regardless of what kind of pipette is used the care taken with pipetting is directly proportional to the overall accuracy and precision of testing To avoid contamination of reagents if the same pipette is being used for both sample and reagent a new tip must be used when transitioning between sample and reagent To avoid cross contamination between samples a new tip should be used for each sample whether running plasma or whole blood samples G Pipetting technique for non repeating pipettes To fill the pipette tip Depress the button to the first stop With the button depressed insert the tip into the sample or reagent to a depth of approximately 2 3 mm If pipetting plasma directly from a centrifuged tube of blood the tip should be kept well away from the blood plasma i
70. lc IDA Business Park Bray Co Wicklow Ireland CE KC is a trademark registered by Trinity Biotech plc O M V 1 1 2 07 03 30 Trinity Biotech Plc IDA Business Park Bray Co Wicklow Ireland Tel 353 1276 9800 www trinitybiotech com 07 03 30 Trinity Biotech GmbH Lehbrinksweg 59 32657 Lemgo Germany Tel 49 5261 9630 Trinity Biotech USA 4 Connell Drive Suite 7100 Berkeley Heights NJ 07922 USA Tel 1 908 898 1500 O M V 1 1 2 TRINITY BIOTECH INSTRUMENT WARRANTY Trinity Biotech Plc Trinity Biotech warrants that instruments it sells are free from defects in workmanship and materials during normal use by the original purchaser or designated agent This Warranty shall continue for a period of one year from the date of invoice to the original purchaser or until title is transferred from the original purchaser whichever occurs first the Warranty Period If any defects occur during the Warranty Period contact the Trinity Biotech Service Centre or its authorised distributor representative immediately and be prepared to furnish pertinent details concerning the defect the model number installation date and the serial number Warranty service for instrumentation purchased direct from Trinity Biotech is provided 8 30 a m through 5 00 p m Monday through Friday except on Trinity Biotech observed holidays For hours of service in areas other than the USA UK and Germany please contact your local authori
71. lected by pressing keys INR APTT FIB etc and confirming with lt gt Incorrect entries may be corrected by pressing the lt DEL gt key Terminating is possible with lt ESC gt Upon termination the previously set values will remain valid 3 Change Single Test Program see also section 4 1 This function allows the operator to individualize the test menu by sample if desired The tests in the Individual Program are chosen directly from the keyboard by pressing keys INR APTT FIB etc and confirming with lt gt Incorrect entries may be corrected by pressing the lt DEL gt key Terminating is possible with lt ESC gt Upon termination the previously set values will remain valid Detailed information for modifying the processing options is described in section 4 Note After selecting 1 2 or 3 the Configuration Menu is exited by pressing ENTER or ESC Now the assay parameters can be defined or modified These entered or modified assay parameters definitions will be valid for all processing options Only the selected configuration of single duplicate testing in the Emergency program has priority over the assay definition replicate selection 4 Delete All Programs The test selections for all of the processing options will be deleted All assay definition settings will also be deleted WARNING All tests in all processing options and all assay definition settings can be deleted with one keystroke A complete new installation of p
72. ll values will be displayed If all values entered are correct press No lt 2 gt or lt gt to save the new entries The FIB test is configured The parameters for the next test will be displayed If there is no next test the Main Menu will be displayed If incorrect values were entered by mistake select Yes lt 1 gt to repeat the whole data entry routine Point 1 Point 2 Point 3 Note Enter the value in g l of the Fibrinogen eine cae yas ic Hie Reference Plasma for the first point in the bce te ok eae curve The value can vary from lot to lot sec 65 0 When using the KC4A coagulation analyzer max pifferencets 5 please note that the clotting time for the Change Yesili NoL2 highest point in the curve must be longer than the KC4A minimum measuring time 4 5 sec This can be achieved by using the Trinity Biotech reference plasma and the optimised dilution ratio contained in the test application Note The recommended dilution ratio and reagent volumes for the Fibrinogen test are contained in the KC4A Fibrinogen Test Application 56 O M V 1 1 2 07 03 30 Kc 49 Amelung 5 11 FIB Flow Chart Test FIB Incubation time Sec 60 Calibration points 5 Point 1 G L 2 20 Sec 12 5 Point 2 G L 1 60 Sec 18 0 Point 3 G L 1 10 Sec 25 0 Press ENTER to continue Test FIB Incubation time Sec 60 Cal
73. modified dilution value will remain valid until the instrument is switched off or the value is modified again Activate the test configuration section 5 1 and the FIB test Following display will appear on the screen To enter more than 3 points press lt gt until the question Modify Yes lt 1 gt No lt 2 gt is displayed Select Yes lt 1 gt to modify the settings Press No lt 2 gt or lt gt to retain the original settings The next test will be displayed For single testing select lt 1 gt Single test For duplicate testing select lt 2 gt Duplicate test Press lt gt to cancel and retain original setting If duplicate test has been selected enter the maximum permitted difference between duplicates and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting The difference will be calculated as follows Difference Difference between Measured and Average value y 100 Average value Enter the incubation time contained in the test application and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting O M V 1 1 2 07 03 30 Incubation time Sec 60 Calibration curve 5 Point 1 G L 2 20 Sec 12 5 Point 2 CGP Tey 1 60 Sec 18 0 Point 3 G L t po Sec 255500 Press ENTER to continue Test FIB Incubation time Sec 60 Calibration c
74. n Run Imprecision CV 1 3 1 1 POL 2 Low Mid High Total Mean 12 1 23 3 40 7 Total Imprecision CV 2 59 7 12 3 0 Within Run Mean 12 1 41 7 Within Run Imprecision CV 2 6 1 8 POL 3 Low Mid High Total Mean 11 3 22 8 34 2 Total Imprecision CV 1 57 7 41 0 50 Within Run Mean 11 4 34 7 Within Run Imprecision CV 2 0 1 3 6 O M V 1 1 2 07 03 30 bienech Kc 49 Amelung 1 4 3 Precision Activated Partial Thromboplastin Time APTT APTT imprecision on the KC4A was evaluated at three levels according to the NCCLS EP5 T2 protocol Low Mid High Mean 28 55 51 01 75 78 Total imprecision CV 3 12 3 41 3 21 Within run imprecision 1 47 1 60 1 37 APTT total imprecision was evaluated at three physician s office laboratories at three levels according to the NCCLS EP10 T protocol Within run imprecision n 20 on each level was evaluated at three physician s office laboratories at two levels POL 1 Low Mid High Total Mean 29 0 43 3 57 6 Total Imprecision CV 2 83 3 15 1 87 Within Run Mean 30 8 57 5 Within Run Imprecision CV 2 7 1 6 POL 2 Low Mid High Total Mean 29 2 42 7 57 0 Total Imprecision CV 4 38 2 29 2 84 Within Run Mean 28 2 57 1 Within Run Imprecision CV 2 1 1 7 POL 3 Low Mid High Total Mean 30 0 54 7 68 6 Total Imprecision CV 1 87 1 80 2 13 Within Run Mean 26 9 64 4 Within Run Imprecision CV 1 4 2 5 1 4 4 Precision Fibrinogen Fibrinogen imprecision was evaluated at three
75. ncubation time sec Mean normal value 12 8 Single test Change Yes 1 Noj 2 Test INR Single test Change Single test 1 Duplicate test 2 Press ENTER to continue Single test Duplicate test Test INR Max Difference 5 Press ENTER to save new entry Press ESC to cancel Test INR Incubation time Sec 60 p Press ENTER to save new entry Press ESC to cancel 52 kC 49 Amelung ISI Value 3 ADI iq Next test or Main Menu Test INR Mean normal value 12 8 ISI Value 1 03 Press ENTER to save new entry Press ESC to cancel Test INR Mean normal value 12 8 Press ENTER to save new entry Press ESC to cancel O M V 1 1 2 07 03 30 Kc 49 Amelung 5 8 APTT or TCT APTT Activated partial thromboplastin time TCT Thrombin clotting time The method for configuring the APTT und TCT test is the same In the example below the APTT test will be described Note The following values are only example values and should be replaced by the values given in the test application ies APRETI Call up the test configuration and the APTT test section 5 1 Following will be displayed on the screen TEU Dat SOS ER MME ela E REED Single test Change Yes 1 Noj 2 Select Yes lt 1 gt to modify the settings
76. ng Screen will display Section 3 16 3 No additional data entries are necessary In this mode patient IDs are not allocated and only the time result will be displayed on the screen Result data cannot be transferred to the printer or to an LIS The measuring channels can be used independently of one another this feature is unique to this mode 3 16 Operating Screen All measurements are directed using the Operating Screen The basic display configuration is dependant on the active program e g patient number test or patient number rack 3 16 1 Operating Screen in Routine and Single Test Program left ID of first patient Pat ID 1 FIB 1 10 right Test to be performed EREDE 1 2 3 4 Measuring channel positions 1 through 4 Incubation time in seconds Inc time 0 0 0 0 Measuring time in seconds Incubation time is running Measurement can be started or is running Measurement is complete active channels with patient allocation displayed 4 different patients in single mode Meas time 0 0 0 0 0 0 0 0 Start Inc Ready e g four patients rack in singleton left ID of first patient Pat ID 1 FIB 1 10 right Test to be performed Measuring channel positions 1 through 4 Position I 2 3 4 5 Incubation time in seconds Inc time 0 0 0 12 j Meas time 14 8 9 3 0 0 0 0 Measuring time in seconds RRIF i i ee eee eres Incubation time ch 4 runnin
77. nstruments SAFETY INSTRUCTIONS SI 2 Location Requirements 1 Sl 2 Locate the Amelung Haemostasis Instrument on a level stable vibration and dust free counter area that allows air circulation to the back of the instrument To allow for adequate instrument cooling there must be at least 10 cm 4 inches between the back of the instrument and any wall It should not be positioned next to centrifuges or other equipment that many cause vibration Minimum Space Requirements includes instrument and peripheral equipment a AMAX Destiny Benchtop version 56 cm H x 68 cm L x 82 cm W 22 in H x 27 in L x 32 in W b AMAX 200 Benchtop version 56 cm H x 82 cm L x 69 cm W 22 in H x 32 in L x 27 in W With base cabinet 127 cm H x 82 cm L x 69 cm W 50 in H x 32 in L x 27 in W c AMAX 400 Benchtop version 62 5 cm H x 140 cm L x 67 5 cm W 25 in H x 56 in L x 27 in W With base cabinet 130 cm H x 140 cm L x 67 5 cm W 52 in H x 56 in L x 27 in W d KC1A Benchtop version 8 cm H x 21 cm L x 14 cm W 3 25 in H x 8 25 in L x 5 5 in W e KC4A Benchtop version 12 cm H x 45 cm L x 35 4 cm W 4 7 in H x 17 7 in L x 13 9 in W Locate the Amelung Haemostasis Instrument in an area of low humidity and little temperature fluctuation It should not be positioned in an area directly below ventilating ducts which produce strong air currents Locate the instrument in an area not illuminated by direct sunlight The instrument must be located
78. nterface This will assure that no red cells or platelets will be aspirated into the tip If pipetting a particulate reagent the reagent should be well mixed prior to aspiration Release the button slowly in such a manner that the sample or reagent flows smoothly into the pipette tip Slow aspiration will assure that the volume aspirated into the tip is accurate If the button is allowed to snap back an incorrect volume may be aspirated In addition sample or reagent can be aspirated into the barrel of the pipette This can result in contamination of subsequent samples or reagents Unless the pipette is dismantled and cleaned inadvertent aspiration into the pipette barrel will result in eventual obstruction and incorrect operation of the pipette Once the tip is filled no dripping should be observed If dripping is observed either the tip is not seated correctly on the pipette or the pipette requires maintenance In such a circumstance replace the tip If this does not correct the problem the pipette should not be used until maintenance can be performed Pipetting technique for Multipettes Only pipette tips recommended for use with the pipette should be used Any pipette tip whose insertion opening is out of round should be discarded Any pipette tips that are bent or otherwise damaged should be discarded The tip opening must not be occluded Slide the filling lever down until it stops then raise the locking clamp upward Insert the Com
79. ome position and the cuvette tray cuvette box transport drive belts will reset itself All instruments The instrument will self start the user interface software AMAX series If any one of the instrument module elements fails during power up an error message is displayed In this situation the operator should contact Instrument Service for assistance AMAX series The instrument start menu displays on the monitor screen AMAX series Initially an lt Error gt message symbol will display as temperature may be out of range After 10 20 minutes the system should reach operating temperature AMAX series As appropriate if the onboard cuvette supply is insufficient a warning message will display W 04 01 21 bieyech Amelung Haemostasis Instruments SAFETY INSTRUCTIONS SI 8 Safely Using the Amelung Instruments If the Instrument is operated according to the instructions of use there will be no danger to life and health of operating personnel SI 8 1 How to Avoid Danger to Life amp Health of Operators 1 AMAX series The Instrument should not be operated without the safety shield in position WARNING AMAX Destiny The Instrument should not be operated without the safety shield in position The safety shield ensures that extraneous light does not cause interference to the photometer and protects the operator from injury which could be caused by the movement of the robot arm 2 Safety clothing espec
80. on time Sec 0 Single test Calibration c Point 1 Ons Point 2i 0 Point 3 0 5 PT max Oooog Without INR calculation Change Yes 1 No 2 Teste PI Single test Change Single test Duplicate test 2 Press ENTER to continue O M V 1 1 2 07 03 30 Kc 49 Amelung If duplicate test is selected enter the max difference CV and press lt gt to save the new entry Press lt ESC gt to retain the original setting The difference will be calculated as follows Difference Difference between Measuring and Average time x100 Average Value Enter the incubation time defined in the test application and press lt gt to save the new entry Press lt ESC gt to retain the original setting Enter the reference values for the PT calibration Curve Point 1 is the point with the highest value and the shortest time The value need not be 100 It may vary according to the source of the reference plasma Example 100 Enter the clotting time for the first point on the PT calibration curve and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting The value of point 1 is the one with the shortest value Example 10 8 seconds Enter the second value for the PT calibration curve and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting The second point is
81. ord New Password Press ENTER to save new entry Press ESC to cancel To change the password enter the new password 4 digits press lt I gt To confirm re enter the new password and complete the entry with lt gt If both new password entries were identical the new password is now valid If the new password entries were not identical the old password remains valid Repeat the Change Password procedure if the error message Incorrect Password is displayed 22 O M V 1 1 2 07 03 30 bienech Kc 49 Amelung 3 6 Run Menu Functions The Run Menu is activated by selecting the lt RUN gt key Selection is only possible when the measuring mode is not active or when no other actions have been activated Start routine program Start emergency program Start single test program Test mode Main menu ENU RUN Menu Start routine program The Routine Program is activated sections 3 1 3 15 1 Start emergency program The Emergency program is activated sections 3 1 3 15 2 Start single test program The Single Test Program is activated sections 3 1 3 15 1 Test mode Clotting times will be measured using this program without using any of the pre programmed test definitions see sections 3 1 3 15 3 MENU Main Menu The Main Menu is activated section 3 4 Ie W N Note When the measurement mode is inactive all programs can be exited using th
82. pletion of the Preliminary Checks of instrument Operation installation is complete and the KC4A instrument is ready for operation If the instrument fails to perform any of the tests with the specifications listed call Instrument Service at Trinity Biotech Note The settings for the TCT Test must be returned to the original settings see section 5 8 18 O M V 1 1 2 07 03 30 bienech Kc 49 Amelung 3 General Operation 3 1 KC4A Programs and their Function The KC4A coagulation analyzer has 4 different operation programs Single Test Program Routine Program Emergency Program Test Mode Program selection is made in the RUN Menu see section 3 6 Single Test Program In the Single Test Program one programmed Test can be activated All samples will be processed using this test until the Single Test Program has been deactivated Patient IDs may be entered individually or counted upwards from a user definable starting number Tests result data will be processed according to the selected replicate configuration i e duplicate or single testing Routine Program In Routine Program several different tests can be put together in a Test Group Each test will be processed as in the Single Test Program one test on several patients To switch to the next test in the group press lt gt The next test in the Test Group will be automatically activated Patient IDs may be entered individually or counted upwards from a user definable start
83. power supply to the thermal printer will be activated when the measuring block temperature has reached 35 C The printer will then be automatically switched on 4 Activate the KC4 A Coagulation Analyzer by pressing the off on switch located on the left hand side of the back of the instrument 5 Observe that the display screen lights up A screen showing a thermometer see section 3 3 appears and will remain displayed while the instrument warms up to 35 C Then the display will switch to the Main Menu se section 3 4 6 Observe that all four of the measurement wells are rotating The wells will rotate continuously whenever the instrument is on 7 Place a KC4A Micro cuvette or Tetravette into each position of the cuvette rack Place the cuvette rack on the rotating test positions such that the cuvettes are sitting flush in the holes If using a KC4A Micro cuvette dispense one ball into each cuvette using the ball dispenser Observe that the ball falls to the front of the cuvette and stays there 8 Verification of temperature can be performed by placing approximately 3 ml of water into a 15 mm reagent tube Place the reagent tube into the Reagent warming wells section 1 5 3 Place a thermometer into the tube and allow to equilibrate until the temperature has stabilized Approximately 15 minutes will be required for temperature stabilization The temperature should be 37 3 0 5 C Note The use of smaller diameter tubes is not
84. press the button to the second stop position Sample should not be dispensed by touching the tip to the upper sidewalls of the cuvette Any sample that is left on the upper walls will not participate in the coagulation reaction 28 Pipet tip Cuvette ___ Sample dispense A eS Ball 12 o clock ee NX A 6 o clock Figure 3 3 O M V 1 1 2 07 03 30 Kc 49 Amelung 3 13 To Dispense the First Reagent For those tests utilizing more than one reagent the first reagent should be dispensed to the 9 o clock position of the cuvette See diagram Aim the pipette to the 9 o clock position Position the tip approximately 3 4 mm above the bottom of the cuvette Depress the pipettor button to the first stop and hold for 1 2 seconds to allow the residual contents of the tip to collect at the bottom of the tip Press the button to the second stop This will deliver any residual reagent into the cuvette To avoid bubbling and splattering the tip should not be placed so close to the bottom that at the completion of pipetting the tip is sulbmersed in the dispensed reagent An alternative method is to touch the tip to the cuvette sidewall approximately 3 4 mm above the bottom of the cuvette and then depress the button slowly to the first stop Wait 1 2 seconds and press the button to the second stop position To avoid contamination of reagent during subsequent reagent pipetting care must be taken to avoid contact of the tip with the
85. previously dispensed sample Pipet tip Cuvette Sample dispense First reagent j 12 o clock dispense 9 o clock e First reagent dispense 9 o clock Front view Side view Figure 3 4 O M V 1 1 2 07 03 30 29 Kc 49 Amelung 3 14 To Dispense the Starting Reagent The Start Reagent is the reagent that when added begins the coagulation reaction Start Reagent should be dispensed just to the right side of the ball This positioning assures that mixing of reagent with the other reaction constituents begins immediately Holding the pipettor obliquely from the right side aim the pipette tip to the right side of the ball Position the tip approximately 5 6 mm above the ball Depress the pipettor button to the last stop position The dispense rate should not be so rapid or forceful that reagent is splashed out of the cuvette To avoid contamination of reagent during subsequent reagent pipetting care must be taken to avoid contact of the tip with the previously dispensed sample and or reagent Refer to the General Operation section for further information on the use of the automatic pipettor with starter cable Pipet tips ES EEE Cuvette Start reagent ni dispense ight side of ball te First reagent dispense LU Sample dispense 9 o clock 12 o clock a Balll oe pane REK 9 o clock Front view Side view Fig
86. procedure is used when no pipette with starting cable is available Press the lt START gt key As a control the lower left field will display Start Meas Simultaneously with the dispensing of the start reagent the measurement timers must started Therefore press the Channel Key simultaneously with start reagent dispense The measurement is started and the measurement timers beginns running Replace the pipette in the heated pipette sleeve O M V 1 1 2 07 03 30 bienech Kc 49 Amelung Note Replace the pipette tube holder sleeves daily and for each new reagent Pipette tube holder sleeves should be treated as biohazardous waste With the addition of start reagent initiation of the coagulation process begins As coagulation takes place fibrinogen polymerizes to form strands of fibrin The formed fibrin sweeps the ball out of its steady position which triggers an impulse in the magnetic sensor This impulse electronically stops the timer signifying the end of measurement time The Ready field will display Measurement has been completed The elapsed time will be displayed in seconds and tenths of seconds When all tests have been completed the actual results will be calculated 3 18 Manual Measurement Abort If a measurement has to be manually aborted because no clot has formed or because a test was incorrectly started press the lt STOP gt key In the bottom left of the Operating Screen STOP will be displa
87. pulse in the magnetic sensor This impulse electronically stops the timer see illustration Cuvette Thermostatically Controlled Incubation Block Magnetic sensor Precision Drive ee Figure 1 1 O M V 1 1 2 07 03 30 Ke 49 Amelung 1 3 Instrument Specifications Type Coagulation Analyzer Bench top Online Unidirectional Principle Ball Method Measuring Channels 4 Display Liquid Crystal Display LCD Incubation Wells 8 Reagent Well 5 Dimensions Height 12cm Width 35 4 cm Depth 45 0 cm Weight 6 3 kg Power supply Primary Voltage Power Consumption Measurement Time Minimum Maximum 100 240 V 50 60 Hz 1 5 A at 100 V 0 4 A at 230 V 4 5seconds 999 9 seconds O M V 1 1 2 07 03 30 bienech Kc 42 Amelung 1 4 Performance Characteristics The overall performance of any testing performed with the KC4A is not only dependent on the instrument but is also a function of specimen collection sample handling techniques and on the accuracy and precision of the sample and reagent dispensing system used 1 4 1 Correlation The following linear regression data were obtained during evaluation to show equivalence with a commercially available mechanical coagulation analyzer Prothrombin Time APTT Number 121 110 Correlation Coefficient 0 998 0 896 Slope 1 051 1 235 Intercept 0 241 0 873 The following linear regression data were obtained during
88. ration section 5 1 and the FAC Incubation time Sec 60 test The following display will appear on the screen ee ee a ot Point 1 100 0 REC gt 4 Lpg To enter more than 3 points press lt gt until the question ENE Aa bate Modify Yes lt 1 gt No lt 2 gt is displayed aes nee 2 R Press ENTER to continue Test EACH FACTOR 10 Ln cru Balt ao pai mie 56 C f 60 Select Yes lt 1 gt to modify the settings oe E a Press No lt 2 gt or lt gt to retain the original settings The Saas meee res 076 next test will be displayed mag ee et oe Max Difference amp 5 Change Yes 1 No 2 Test FAC For single testing select lt 1 gt Single test Single test For duplicate testing select lt 2 gt Duplicate test OPIRE Press lt gt to cancel and retain original setting E EE NAN 1 Duplicate test 2 Press ENTER to continue Test FAC If duplicate test has been selected enter the maximum pern between duplicates and press lt gt to save the new entry 2 Difference 25 Press lt ESC gt to cancel and retain the original setting Press ENTER to save new entry The difference will be calculated as follows Press ESC to cancel Difference Difference between Measured and Average value x 100 Average value Test FAC Incubation time Sec z 60 Enter the incubation time contained in the test application and press l
89. rd Curve Dilutions ccccccceeeeeeeceeeeeeeeeeeeeeteeeeeees 77 2 O M V 1 1 2 07 03 30 biS lech Kc 49 Amelung 1 Introduction 1 1 Intended Use The KC4A Amelung is a semi automated mechanical clot detection system designed for the determination of prothrombin times PT activated partial thromboplastin times APTT fibrinogen concentrations and other clotting tests Any clotting time test that has fibrin formation as its endpoint may be performed on the KC4A Measurement can be qualitative or quantitative When used in conjunction with appropriate reagents the sample can be plasma or whole blood Addition of both sample and reagents is manual The time measurement of the clotting endpoint is automated 1 2 Principle of Operation The system utilizes a special cuvette in which there is a stainless steel ball Sample is added to the cuvette After an appropriate incubation period the cuvette is placed into the measuring well of the KC4A The measuring well rotates slowly causing the cuvette to rotate along its longitudinal axis Because the cuvette is positioned at a slight angle gravity and inertia always position the ball at the lowest point of the cuvette Exactly opposite the ball position is a magnetic sensor With the addition of appropriate reagent a timer is started As coagulation takes place fibrin strands form in the reaction mixture The fibrin strands pull the ball away from its inertia position that triggers an im
90. recommended due to inadequate heat transfer The thermometer should not drain heat from the measuring medium water To verify the functionality of the sensors the Multipette with the starting cable should be used Note Settings made during the Performance Checks may vary from the previous settings and may require that changes be made to the programming 9 Inthe Main Menu press lt 3 gt to enter the Configuration Menu O M V 1 1 2 17 07 03 30 biS lech Ke 49 Amelung 10 Enter the password default password is 1 2 3 4 Press lt gt The Configuration Menu will display 11 To select language press 5 Change language keypad 12 Make an appropriate language and keypad assignment selection Press lt gt 13 Press 3 Change Single test program press TCT Thrombin Clotting Time key Confirm with lt gt 14 To access the program settings press lt gt 15 Press 1 YES to change the TCT settings 16 Press 2 duplicate testing and 10 for the allowed CV press lt gt to store entry and continue 17 Enter incubation time of 10 seconds Press lt gt to store entry and continue 18 Press 2 No The settings will be stored 19 Press lt RUNs gt to access the RUN Menu see section 3 6 20 Select 3 Start single program 21 Press the TCT Thrombin Clotting Time This activates the TCT Test 22 For Quantity Samples per rack press 2 Then press lt I gt twice to bring up the operat
91. rograms is necessary if all programs are deleted O M V 1 1 2 21 07 03 30 Ke 49 Amelung 5 Change Language Keypad After pressing lt 5 gt a new menu will be activated in which the languages German English or French may be selected In the same menu the keypad options lt PT gt or lt NT gt and lt Ratio gt or lt TT gt may be selected Language By pressing lt 1 gt GERMAN lt 2 gt ENGLISH or lt 3 gt French the corresponding language will be selected The current selection is indicated by after the number Keypad By pressing the key lt 7 gt PT und RATIO or lt 8 gt NT und TT activates the keypad for the corresponding tests The current selection is indicated by after the number Note If the keypad configuration is modified all tests selected for all processing options Routine Emergency and Single Test Programs will be deleted section 4 The assay definitions will remain stored 6 Change Password The Configuration Menu is protected from interference by unqualified personnel by a 4 digit password The default password is 1234 and may be changed to a laboratory specific password The default password is then invalidated For that reason please make sure that the new password does not get forgotten Without the new password the Configuration Program can no longer be accessed Press lt ESC gt during the new password entry and the old password will remain valid Change Passw
92. sed Trinity Biotech distributor Any service performed at other times and all service required to correct defects or malfunctions not covered by this Warranty will be billed on a time and material basis at Trinity Biotech s labour rates then in effect This Warranty does not cover defects or malfunctions which 1 are not reported to Trinity Biotech or it s authorised distributor during the Warranty Period and within one week of occurrence 2 result from chemical decomposition or corrosion 3 are described in the applicable Trinity Biotech Guide 4 result from maintenance repair or modification performed without Trinity Biotech s or it s authorised distributor s prior written authorization or 5 result from misuse abuse or accident Trinity Biotech s liability for all matters arising from the supply installation use repair and maintenance of the instrument whether arising under this Warranty or otherwise shall be limited solely to the repair or at Trinity Biotech s or it s authorised distributor s sole discretion replacement of the instrument or of components thereof In no event shall Trinity Biotech or its authorised distributors be liable for injuries sustained by third parties incidental or consequential damages or lost profits Replaced parts shall become the property of Trinity Biotech or its authorised distributors THE FOREGOING IS THE SOLE WARRANTY MADE BY TRINITY BIOTECH REGARDING THE INSTRUMENT AND
93. sured Displays incubation times clotting times programming selections and other menus 1 6 Keypad Kc 49 Amelung ET Psy N J T ie i WU TZ FE onl if MEM Figure 1 3 Item Function Description 1 START Key Activates the automatic measurement timer 2 Incubations Key Starts the incubation timers 3 READY Key Skips the incubation time 4 Channel Key Activates the corresponding measuring channel for incubation time measurement or abort 5 STOP Key Interrupts measurement 6 Function Keys Used for programming or selecting tests T MENU Key Returns to Main Menu 8 RUN Key Returns to RUN menu 9 lt 4 Enter ENTER 10 ESC Key Cancels a function 11 PRINTER Key Printer LIS Activates the output menu 12 DILUTION Key Used to change the patient dilution for the FIB test Section 5 10 13 DEL Key Delete Deletes the previous entry 10 O M V 1 1 2 07 03 30 bieyech Kc 4 Amelung 1 7 Back View Figure 1 4 Item Function or Description 1 Label 2 Automatic Multipette s sockets Used to connect Multipipettes remove the cap plug in the Multipette 3 Power input Used to connect the instrument to the power supply Thermal printer port Thermal printer connection Power switch Powers
94. t gt to save the new entry Press lt ESC gt to cancel and retain the original setting Pire SS VENTER Ro save new entry Press ESC to cancel 58 O M V 1 1 2 07 03 30 Kc 49 Amelung Enter the Factor code to be used and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original settings Note If an inverse calibration curve is to be entered FAC the factor code entry will not be used If an inverse calibration curve is already entered entry of the factor code will not be requested Enter the number of calibration points and press lt gt to save the new entry minimum of 3 maximum of 9 points Press lt ESC gt to cancel and retain original settings Factor Calibration Curve data entry Enter the FAC calibration reference plasma value and press lt gt to save the new entry Point 1 is the point with the highest and the shortest time The value need not be 100 Enter the clotting time in seconds for the first FAC calibration curve point and press lt gt to save the new entry Point 1 is the point with the shortest time Press lt ESC gt to cancel and retain the original settings Repeat the last two actions for all points until all of the defined points have been programmed Test FAC Factor t 10 Qe fg Pgs Big SE UO Wi Dag 12s 72 Prees s ENTER to save new entry Press ESC to cancel Test FAC Curve Points 3 Press
95. tatically controlled measuring block has reached 35 C TRINITY BIOTECH KC4 DELTA Versibomst V2 3 Temperature Display In approximately 20 minutes the analyzer will reach operating temperature 37 3 C 0 5 C The display will change to the MAIN MENU 3 4 Main Menu Functions The Main Menu Screen will be activated using the lt MENUs gt key This is possible when no measurements are currently being performed and no data entries have been made The Main Menu will also be automatically displayed after switching on the KC4A and attainment of a measuring block temperature of gt 35 C Main Menu Date 1 Jan 2000 1 Time 00 12 2 Configuration Menu 3 Le Print Parameters RUN Menu RUN Main Menu Main Menu Functions Key Function lt 1 gt Date entry the new date will replace the old date lt 2 gt Time entry the new time will replace the old time lt 3 gt Activates the Configuration Menu see section 3 5 If the optional printer is connected selection of lt 4 gt will print out all the tests defined in lt 4 gt each of the processing options Routine Emergency Single and the settings of all tests lt RUN gt Activates the RUN Menu see section 3 6 Note When the KC4A is switched off the Date Time and test settings will remain active for approximately 2 weeks If the instrument remains unused for longer periods the test settings must
96. th Ball Dispenser 111028 KC Pipette Tube Sleeves These are consumable items and should be ordered as needed O M V 1 1 2 07 03 30 bi W h 15 Kc 49 Amelung Pipettes are required for the test performance Although the use of a Multipette will ensure the start of the timing measurement is simultaneous with the addition of the reagent it is not mandatory Read the Operation Manual carefully prior to using the KC4A Coagulation Analyzer The Operation Manual has been written to provide the most comprehensive understanding of the operation of the KC4A Coagulation Analyzer and to enable you to fully utilize the features of the instrument 2 3 Location Requirements 1 Place the KC4A Coagulation Analyzer on a stable vibration and dust free work surface It should not be positioned next to a centrifuge or other equipment which may cause vibration The KC4A Coagulation Analyzer should also be protected from moisture 2 To avoid exceeding the control range of the instrument place the KC4A Coagulation Analyzer in an area with a maximum room temperature of 30 C It should not be positioned in an area directly below ventilating ducts which produce strong air currents Do not expose the KC4A Coagulation Analyzer to direct sunlight Sunlight influences the temperature control 3 Itis preferable to place the KC4A Coagulation Analyzer in an area which is no further than 6 ft 1 8 m from an electrical outlet The instrument sho
97. the maximum value to be reported for the PT in and press lt gt to save the new entry Press lt ESC gt to cancel and retain the original setting Values which are higher than the defined PT max will not be evaluated and is reported as gt defined PT max value Example 130 If the INR is to be calculated the ISI value must be entered Press lt gt to save the new entry The standard value does not need to be entered It will be calculated from the calibration curve If the ISI value O is entered no INR value will be calculated Press lt ESC gt to cancel and retain the original setting Example 1 03 In conclusion all values will be displayed If the values have been correctly entered complete the entry with No lt 2 gt or lt gt The PT test is configured All parameters of the following tests are now displayed If there are no tests to follow the Main Menu will be activated Ke 49 Amelung Calibration Point 3 E he Aa curve Press ENTER to Save new Press ESC to entry Pulls cancel Calibration Point 3 sec Si lie curve Press ENTER to Save new Press ESC to entry 4 PT cancel Calibration PT max 13 0 curve 0 Press ENTER to Save new Press ESC to entry Pr cancel Cadi ib Bact Calculate With INR enter ISI Without enter BSE ISI value on Curve INR
98. the printer and printed These results will not be displayed on the Operating Screen New measurements can be performed on the KC4A coagulation analyzer during the printing of results O M V 1 1 2 07 03 30 35 Ke 49 Amelung Example Result Output with Printer 05 Feb 2004 10 34 Single Test Program PT Patient ID 123456 Measured values 11 9 sec 12 1 sec Average value 12 0 sec Difference 0 8 Result 108 3 INR 1 17 Note The end of the paper roll is indicated with red diagonal stripes When these stripes are visible insert a new roll of paper Result Output without the Optional Printer The KC4A coagulation analyzer default settings presume that the optional printer will be installed see section 1 10 The first attempt to transfer data and results to the printer will provoke the screen display Printer error Please check if printer is installed correctly and switched on Or press ESC to disable printout Press the lt ESC gt key and the error message will be deleted The raw data and calculated results for each patient or in Emergency program each test will now be displayed on the KC4A screen Press the lt gt key to scroll to the next result After the last result has been displayed press the lt gt to perform more tests in the Routine or Emergency Program If all tests in the Emergency Program have been performed the Emergency Program will be deactivated after the last Emergency result has been displa
99. uld not be operated from an extension cord which does not employ protective grounding The electrical outlet used should not be shared with any devices which consume large amounts of power on a cyclic basis e g centrifuges air conditioners and refrigerators When these type of devices cycle on and off there may be a voltage drop in the line which could interfere with the proper functioning of the instrument 2 4 Electrical Requirements and Precautions The KC4A is connected to the mains power circuit by way of an external power pack Using the power pack connection cable connect the power pack to the KC4A Using the power supply cable provided connect the power pack into the mains supply circuit 1 Do NOT use an extension cord not equipped to provide protective grounding 2 The KC4A is factory equipped with a three pronged grounding plug designed to be connected with a matching three pronged receptacle Under no circumstances should it be connected to an ungrounded two pronged plug This procedure is in accordance with the National Electrical Code and other applicable ordinances for this type of installation 3 Itis recommended that a Trinity Biotech service representative perform any repair work other than routine maintenance and minor adjustments 4 If instrument safety is uncertain the instrument may no longer be operated WARNING Use only the external power supply provided with the instrument otherwise damage will be c
100. ure 3 5 O M V 1 1 2 07 03 30 30 Kc 49 Amelung 3 15 Selecting Operating Program and Starting To activate the operating programmes bring up the RUN Menu section 3 6 using the lt RUN gt key Using the keys lt 1 gt lt 2 gt lt 3 gt or lt 4 gt select the desired program section 3 1 Note Before the Routine Single Test or Emergency Programs can be activated the corresponding test must have been configured in the Configuration Menu see section 4 Mode Programming 3 15 1 Starting Routine or Single Test Program After selecting Start Routine Program or Start Single Test Program you will be asked how saat a222 many samples are to be measured in one rack Max defines the maximum number of samples Sample per Rack For singleton testing it is four 4 for duplicate Number testing it is two 2 samples aie FF Enter the number of patients Note Use the key lt gt to set the number to Max Requesting the number of patients rack After entering the number of patients you will be asked how the sample IDs are to be assigned There are two possibilities Routine Program 1 The sample ID will automatically incremented by one beginning with the number displayed Patient ID 1 in Patient ID Use key lt 1 gt to edit the starting number Sranie eae Kariere ii a Press lt gt to activate this option Manual input of Pat ID 2 Press enter to cont
101. urve 5 Point 4 G L 0 75 Sec 45 0 Poirt 5 G L 0 55 Sec 65 0 Max Difference 5 Modify Yes 1 No 2 Test FIB Single Test Change Single test 1 Duplicate test 2 Press ENTER to continue Dest EIB Max Difference 5 Press ENTER to save new entry Press ESC to cancel Testi FEB Incubation time Sec 60 Press ENTER to Save new entry Press ESC to cancel 55 Enter the number of calibration points and press lt gt to save the new entry minimum of 3 maximum of 9 points Press lt ESC gt to cancel and retain original settings Enter the FIB calibration reference plasma value Point 1 is the point with the highest value Gram Litre and the shortest time Enter the clotting time in seconds for the first FIB calibration curve point and press lt gt to save the new entry Point 1 is the point with the shortest time Press lt ESC gt to cancel and retain the original settings Ke 49 Amelung Testr BL B Curve points 5 Press ENTER to save new entry Press ESC to cancel Calibration curve FIB Point 1 G L Spree Press ENTER to save new entry Press ESC to cancel Calibration curve FIB Point 1 Sec T 5 Press ENTER to Save new entry Press ESC to cancel Repeat the last two actions for all points until all of the defined points have been programmed The last point is the point with the smallest g l value and the longest time In conclusion a
102. yed 3 19 3 Result Output to LIS Laboratory Information System Simultaneously with the output of result data to the display or the printer the data will also be transferred to the LIS interface It is an RS232 interface and is on the back of the KC4A labelled with PC Serial If this interface is not being used there is nothing which needs to be observed or set If the interface is to be used it is possible to select if results with error flags are to be transferred or not section 3 7 3 19 3 1 PC SERIAL Interface Specifications gt Baud rate 9600 Bit sec gt Complete ASCII Character Set 1 Start bit 7 Information bits Bit 1 7 odd or even parity parity disabled or 8 Bit without parity 2 Stop bits gt 9pin Sub D Connecter DBY Pin 2 RXD Pin 3 TXD Pin 5 GND 36 O M V 1 1 2 07 03 30 bienech Kc 4 Amelung 3 19 3 2 Data protocol for the PC SERIAL Interface Byte 7 6 5 4 3 2 1 O Bit Example 1 11 0 0 0 0 0 0111 0 STX STX Start of text 2 A 3 P 4 T Left justified 5 T 6 i 710 0 1 0 0 010 10 Blank Space _ 8 9 i 10 1 11 2 12 3 Right justified 13 4 14 5 15 6 16 a 17 0 0 1 0 0 0 0 0 Blank Space 18 19 1 20 2 Right justified 21 22 ee 23 0 0 1 0 0 0 0 0 Blank __ Space 24 1 25 2 Right justfi
103. yed confirming that the stop procedure has been initiated Press the corresponding Channel timer key Z to stop the measurement in that channel STOP will display in the corresponding position in the Operating Screen No result will be calculated for this measurement If more patients rack were selected than will actually be measured then these can be aborted without starting If patient numbers are set to automatically increment patient number will still be allocated even for aborted measurements 3 19 Result Output 3 19 1 Result Output in Test Mode Program If measurements are performed using the Test Mode program only the measurement timer will be stopped The measuring time can be read off the Operating Screen There will be no calculation of raw data transfer of data to the printer or transfer of data to the LIS interface 3 19 2 Result Output in Routine Emergency or Single Test Results will be automatically calculated and released when all activated measurements have been completed Activated measuring channels are indicated by a number or a test code in the bottom line of the Operation Screen section 3 16 If a measuring channel does not conclude a measurement while e g no clot is formed then the measurement must be manually aborted see section 3 18 Result Output with Optional Printer If the printer has been correctly installed see section 1 10 2 5 3 the raw data and calculated results will be transferred to

- Frank`s Hospital Workshop

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