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Sigma Amelung KC4 Delta

1. 1 1 1 3 PHYSICAL SPECIFICATIONS 1 2 1 4 PERFORMANCE SPECIFICATIONS 1 3 1 5 PHYSICAL DESCRIPTION 1 6 1 6 FRONT VIEW FIGURE 1 2 2 022222 0 1 7 LT KEYPAD FIGURE 2D usina 1 8 1 8 BACK VIEW FIGURE 3 4440422044 0 0 1 9 1 9 MULTIPETTE FIGURE 4 85 1 10 1 10 BALL DISPENSER FIGURE 5 1 11 1 11 THERMAL PRINTER FIGURE 6 1 11 1 12 PRINTER OPTIONS 2 caso conan 506 nennen 1 12 October 2001 SIGMA 60 AMELU NG 1 0 EN 4 AT Introduction 1 1 Intended Use The KC4 ATM Coagulation Analyzer is a semi automated mechanical clot detection system designed for the determination of prothrombin times PT activated partial thromboplastin times APTT fibrinogen concentrations determined by Clauss methodology and other clotting assays Any clotting based assay which has fibrin formation as its endpoint may be performed on the KC4 AM Coagulation Analyzer Measurement can be qualitative or quantitative When used in conjunction with appr
2. 3 7 3 11 TO DISPENSE FIRST 3 8 3 12 TO DISPENSE START 3 9 3 13 SELECTING A TEST TO BEGIN RUN 3 10 3 14 PATIENT IDENTIFICATION 0 3 11 8 15 TESTING e d E ea PE KE SU VENE 3 11 3 16 MANUAL START 3 12 3 17 AUTOMATIC START PROCEDURE 3 12 2 18 PRINTING RESULTS sii 3 13 October 2001 SIGMA AMELU NG 3 0 EN 4 AT General Operation 3 1 Instrument Preparation The is activated by the on off button located on the back of the instrument Turn instrument on and select appropriate language Press lt 1 gt Note This screen will only appear the first time the analyzer is turned on After a language has been selected the analyzer will automatically display the temperature indicator screen shown below on each subsequent power on Sprachwahl Deutsch ln AB N Englisch Franzoesisch Italienisch Niederlaendisch Spanisch Weiter mit Taste ENTER 3 2 Temperature Indicator Screen In this figur
3. 2 0 6 6 6 6 1 MAINTENANCE 4 21 0 1 1 1 00 6666 6 7 1 8 5 2 2 6 6 8 1 8 1 TROUBLESHOOTING FLOW 8 1 8 2 TROUBLESHOOTING PROCEDURES 8 1 APPENDIX 1666 6 1 INR FAST TRACK Bel Vie dan Bi 1 AZ APTIT FAST TRACK ia A 2 FIBRINOGEN FAST TRACK bla A 3 4 FIBRINOGEN CALIBRATION CURVE DILUTION A 4 A 5 EXTRINSIC FACTORS II V VII AND X FAST TRACK A 5 EXTRINSIC FACTOR STANDARD CURVE DILUTIONS A 6 INTRINSIC FACTORS VIII IX XI AND XII FAST 7 INTRINSIC FACTOR STANDARD CURVE DILUTIONS A 8 TOC 2 EN SIGMA AMELUNG October 2001 4 A Introduction Contents 1 1 5 2 22022 0000205555555 0 5 5552556 us 1 1 1 2 PRINCIPLES OF
4. 5 1 5 2 INR FLOW 5 3 5 3 PROTHROMBIN TIME PERCENT ACTIVITY 5 4 5 4 PT PERCENT ACTIVITY FLOW 5 7 5 5 RATIO FLOW CHART sra aii 5 8 5 6 ACTIVATED PARTIAL THROMBOPLASTIN 5 9 5 7 APTT FLOW CHART nee 5 11 5 8 FIBRINOGEN s 5 12 5 9 FIBRINOGEN FLOW CHART 5 15 5 10 FACTORS su 5 16 5 11 FACTORS FLOW CHART eu 5 19 5 12 STATS 5 20 October 2001 SIGMA AMELU NG 5 0 EN 4 A Test Programming 5 1 INR The INR International Normalized Ratio is the preferred method for reporting Prothrombin Times in the United States The PT percent activity curve and ratio are preferred in Europe Allow the instrument to reach 37 C prior to testing SIGMA AMELUNG KC 4 DELTA DATE TIME 10 08 12 Sep 2001 PROGRAM SELECTION PRINT PARAMETERS Prior to testing a Test Program or profile needs to be established The three programs available are discussed in Section 4 The Individual Program will be used here At the MAIN MENU Press 3 Program Selection Enter 4 digit Password Press lt J gt 4 Select Individua
5. Coagulation Analyzer Start Up Kit Carefully remove the instrument and accessories from the transport box Check that the following items have been included KC4 A Coagulation Analyzer 1 Power Cable 2 KC Micro Tetravettes 3 KC Delta Multipette with Starter Cable and Adapter Cord 4 Combitips 1 25 ml 5 each 5 KC Pipette Tips Yellow 200ul 1 tray 6 Tubes Plastic 14 5 x 85 mm 100 each 7 Tubes Glass 15 x 85 mm 50 each 8 Power Supply 12V 9 Lead for Power Supply 10 Protective Dust Cover 1 each Optional Items Catalog Number Item 1 P2864 KC Series Printer with Power Adapter 2 K1638 KC Series Thermal Printer Paper 3 K4882 KC4 ATM Multipette with Starter Cable 4 K0508 KC4 ATM Combitips 1 25 ml 5 KC4 ATM Combitips 2 50 ml 6 K4257 KC Pipette Tips Yellow 200 10 trays 7 T9304 Tubes Glass 15 x 85 mm 50 each 8 4887 KC4 Tetravettes 9 T2242 Tubes plastic 14 5 x 85 mm 10 K1635 KC Micro Cuvettes with Ball Dispencer 11 A6083 Coated Stir Bar 12 K6208 APTT Stir Bar 13 K0633 KC Pittette Tube Sleeves October 2001 SIGMA 60 AMELU NG 2 1 EN 4 AT Installation These are consumable items and should be ordered as needed 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 pri
6. 6 Press lt gt Enter Password Press to continue Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Tests In individual program FIB New entry press ENTER J to store Press ESC to cancel 5 12 EN SIGMA 0 AMELUNG October 2001 4 A Test Programming 7 To modify select Yes 1 to change or No 2 to Program FIB test in leave as programmed Incubation Time sec Calibration Curve FIB Point 1 G L sec Point 2 G L sec Point 3 G L sec Dilution Max Difference 96 Modify Yes 1 No2 8 Press Yes 1 if testing is to be done in duplicate MN FIB Program or Press No 2 if in single Double Test Yes 1 No 2 Max Difference 20 Press to continue 9 Enter the maximum difference allowed where Max Difference 36 Max difference 90 difference between values divided by the Mean value x 100 New entry press J to store Press ESC to continue 10 Press lt J gt to continue changing parameters FIB Program Double Test Yes 1 No 2 Max Difference 96 Press to continue October 2001 SIGMA 60 AMELUNG 5 13 EN 11 12 13 14 15 16 17 18 19 20 21 22 23 4 A Test Programming Choose the incubation time referenced in the test application Enter the refe
7. 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 KC4 ATM 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 C measurement well is rotating Instrument Error Nonfunctional sensor or thermostat overheating Place approximately 3 ml water into a 15 mm test tube Insert a thermometer Observe temperature after a 10 15 minute equilibration period Call Sigma Diagnostics Technical Service 1 800 325 0250 Controls are in range Unexpected results on patient samples Pre Analytical error Overfill or underfill 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 October 2001 SIGMA 0 AMELUNG 8 1 EN 4 A Troubleshooting Symptoms Possible Causes Corrective Action continued Pre Analytical error Failure to correct citrate volume Controls are in Ratio of
8. Point 2 96 sec Point 90 sec PT MAX 96 Difference Check PT No Modify Yes 1 No2 8 Press Yes 1 if testing is to be done in duplicate or No 2 if in single PT Program Double Test Yes 1 No 2 Max Difference 96 Press to continue more parameters 9 Enter the maximum difference allowed where Max Difference Max difference difference between values divided by the mean value x 100 New entry press J to store Press ESC to continue 10 Program the incubation time referenced in the Program PT test application dun Incubation Time sec 11 Enter the reference value of the PT calibration Calibration Curve PT curve This is the first point the highest point of the curve This does not have to be 100 it may epe qu vary depending on the source of the reference sec plasma Point 2 96 12 Enter the clotting time in seconds of the first sec point of the PT calibration curve Point 96 sec PT MAX 96 Max Difference 10 Modify Yes 1 No2 October 2001 SIGMA 60 AMELU NG 5 5 EN 4 A Test Programming 13 Enter the second value of the PT calibration curve The second point the middle point of the curve is a dilution of the reference plasma Example 30 is used Calibration Curve PT Point 1 06 Program PT Incubation Time sec 14 Enter the clotting time in seconds for the middle point of the PT calibra
9. Program 5 NEXT TEST Double Test Yes 1 No 2 Difference Check No Press ENTER J to continue October 2001 SIGMA 60 AMELUNG 5 19 EN 4 AT Test Programming 5 12 STATS STATS are programmed in Section 4 2 Emergency Program 1 From the MAIN MENU or if ROUTINE testing is in progress press lt J gt to bring up the Operating screen From the keypad press RUN At the Test Selection Screen choose Emergency Program 2 to bring up the Operating Screen If 2 beeps sound nothing has been programmed see Section 4 4 If multiple tests are grouped the STAT Mode press lt I gt to change to other tests in the group 5 20 EN SIGMA AMELUNG October 2001 KC4 A 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 October 2001 SIGMA 60 AMELU NG 6 1 EN KC4 A 7 Maintenance Introduction There is no routine mechanical maintenance associated with t
10. Power Supply Voltage Power Consumption Temperature Control Reagent Warming Wells Reaction Incubation Wells Measurement Wells Measurement Time Minimum Maximum Coagulation Analyzer Bench Top Unidirectional Ball Method 4 LCD 12 0 cm 35 4 cm 45 0 cm 6 3 kg 110 220V 50 60 HZ 1 5A at 100V 0 4A at 220V 37 0 C 0 5 C 37 0 C 0 5 C 37 0 C 0 5 C 4 5 seconds 999 9 seconds 1 2 EN SIGMA 0 AMELUNG October 2001 4 AT Introduction 1 4 Performance Specifications The overall performance of any testing performed on the KC4 ATM Coagulation Analyzer is dependent not only on the instrument performance but is also a function of specimen integrity collection and handling as well as accuracy and precision of the sample and reagent dispensing system being used Correlation The following linear regression data was obtained during evaluation to show equivalence with a commercially available mechanical coagulation analyzer Activated Partial Prothrombin Time Thromboplastin Time Number of Samples 121 110 Correlation Coefficient r 0 998 0 896 Slope 1 051 1 235 Intercept 0 241 0 873 The following linear regression data was obtained during evaluation to show equivalence with a commercially available photo optical coagulation analyzer Fibrinogen Factor X Factor IX Number of Samples 109 112 101 Correlation Coefficient r 0 930 0 974 0 897 Slope 1 067 1 010 0 958 Interce
11. Warm APTT reagent and CaClz to 37 C Prepare 1 5 sample dilutions Place cuvettes into rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using a Tetravette Pipette 50 ul diluted sample patient test plasmas are prepared by diluting plasma 1 10 with Imidazole Buffer into bottom of each cuvette Add 50 appropriate Factor Deficient Plasma Close flap remove rack from preparation area and swirl gently 4 5 times Transfer rack into heated incubation area or into the rotating test positions Incubate for 240 seconds This is the TOTAL incubation time for the test a combination of the sample warm up plus the warming of the APTT reagent Press to prepare Incubation Timers and then press for each channel with sample in cuvette At 185 seconds add 50 ul APTT reagent 18 Upon completion of incubation timing for the last well being tested place rack into rotating test positions and open flap Press START Begin dispensing 50 ul CaCl into cuvettes Using the Multipette measurement timing begins automatically Record results Refer to test application October 2001 SIGMA AMELUNG A 7 EN KC4 AT APPENDIX 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 1 5 1 0 0 5 1 20 1 0 1 10 1 0 0 25 1 40 1 0 1 20 1 0 0 125 1 80 1 0 1 40 1 0 0 0625 8 SIGMA
12. 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 position 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 7 or Multipette 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 Directio
13. 0 AMELUNG October 2001
14. 1 3 1 1 POL 72 Low Mid High Mean seconds 12 1 23 3 40 7 Total Imprecision CV 2 59 7 12 3 0 Mean seconds 12 1 41 7 Within Run Imprecision CV 2 6 1 8 POL Low Mid High Mean seconds 11 3 22 8 34 2 Total Imprecision CV 1 97 7 41 0 50 Mean seconds 11 4 34 7 Within Run Imprecision CV 2 0 1 3 1 4 EN SIGMA AMELUNG October 2001 4 A Introduction Precision Activated Partial Thromboplastin Time APTT Imprecision was evaluated at three levels according to the EP5 T2 protocol Low Mid High Mean seconds 28 55 51 01 75 78 Total Imprecision CV 3 12 3 41 3 21 Within Run Imprecision CV 1 47 1 60 1 37 APTT total imprecision was evaluated in three physician s office laboratories POL at three levels according to NCCLS EP10 T protocol Within Run imprecision was evaluated in three physician s office laboratories at two levels POL 1 Low Mid High Mean seconds 29 0 43 3 57 6 Total Imprecision CV 2 83 3 15 1 87 Mean seconds 30 8 57 5 Within Run Imprecision CV 2 7 1 6 POL 2 Low Mid High Mean seconds 29 2 42 7 57 0 Total Imprecision CV 4 38 2 29 2 84 Mean seconds 28 2 57 1 Within Run Imprecision CV 2 1 1 7 POL Low Mid High Mean seconds 30 0 54 7 68 6 Total Imprecision CV 1 87 1 80 2 13 Mean seconds 26 9 64 4 Within Run Imprecision CV 1 4 2 5 Precision Fibrinogen Imprecision was evaluated at three levels according to the NCCLS EP5
15. Difference New entry press J to store Press ESC to continue PT Program Double Test Yes 1 No 2 Difference Check No Press to continue October 2001 SIGMA 60 AMELUNG 5 7 EN 4 A Test Programming 5 5 Ratio Flow Chart PROGRAM RATIO PROGRAM RATIO P Incubation time sec 0 Incubation time sec 0 Default Value 0 0 Default Value 0 0 Max Difference Difference Check RATIO No RATIO No Modify Yes 1 No 2 Modify Yes 1 No2 Program RATIO RATIO Program Incubation time 0 Double Test Yes 1 No 2 New entry press J to store Press ESC to continue Max Difference 96 Press J to continue Y Press ESC to continue Program RATIO Default Value N t to st Max Difference 90 Press ESC to continue New entry press J to store Press ESC to continue PROGRAM RATIO Incubation time sec O Default Value 0 0 RATIO Program Double Test Max Difference 20 5 Yes 1 No 2 RATIO No Modify Yes 1 No2 Max Difference 96 Y NEXT TEST Press J to continue 5 8 EN SIGMA AMELUNG October 2001 4 A Test Programming 5 6 Activated Partial Thromboplastin Time Allow the instrument to reach 37 C prior to testing SIGMA AMELUNG KC 4 DELTA DATE TIME 10 08 12 Sep 2001 P
16. pipette tip Dispense one aliquot of reagent into reagent container to prime the pipette tip Press the START key Fully depress the pipetting lever to dispense reagent This is best accomplished by holding the pipette angled obliquely from the right rear side and dispensing the reagent just to the right side of the ball Measurement timing is started automatically Return the pipette to the heated pipette tube holder Note Replace the pipette tube holder sleeves daily and for each new reagent Pipette tube holder sleeves should be treated as biohazardous waste 3 12 EN SIGMA AMELUNG October 2001 4 AT General Operation Note To increase speed when using an automatic multipette with starting cable simple keep the Start Key of the first channel depressed while pipetting Thus when channel 1 is pipetted and the timer for channel 1 is started the timer for channel 2 is activated When channel 2 is pipetted its timer begins and channel 3 s timer is activated etc 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 elapsed time will be displayed in seconds and tenths of seconds 3 18 Printing Results 1 The
17. related Incorrect volume of reagent being used Reagent related Reconstitution with incorrect diluent volume Follow manufacturer s instructions Follow manufacturer s instructions Reagent related Reconstitution with other than the recommended diluent Follow manufacturer s instructions 8 2 EN SIGMA 0 AMELUNG October 2001 4 A Troubleshooting Symptoms Possible Causes Corrective Action continued Reagent related Lot to lot variation in reagent Controls out of New lot number of reagent reactivity is not unusual Re range with different reactivity verify reference range Prepare Unexpected results Reagent related Reagent defective due to mishandling in shipping or storage new reference curves as appropriate 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 cont
18. the instrument 2 4 Electrical Requirements The KC4 ATM Coagulation Analyzer is designed with a factory equipped three pronged grounding plug designed to be connected to the Power Supply which is then plugged into the analyzer Under no circumstances should it be connected to an ungrounded two pronged receptacle This procedure is in accordance with the National Electrical Code and other applicable ordinances for this type of installation 1 Do not use an extension cord which cannot to provide protective grounding 2 Itis recommended that any repair work other than routine maintenance be performed by a trained specialist familiar with the hazards involved 3 Ifsafe operation of the KC4 ATM Coagulation Analyzer is no longer possible the instrument must be taken out of service 2 2 EN SIGMA AMELUNG October 2001 4 A Installation 2 5 Preliminary Check of the Instrument Operation 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 power cable to power cable socket on back of instrument DC6 5V 2A Connect the Data Cable from the Serial Port on the Printer to the Printer port on the back of the Analyzer if utilizing KC4 AM printer Activate the KC4 ATM Coagulation Analyzer by pressing the of
19. 8 PRINTING 000 3 13 4 PROGRAMMING csssccssssccessscesssescesstecesseecesstceesececesesecsseeecesseeeesseceeseeees 4 1 4 1 ROUTINE PROGRAMMING 4 1 4 2 EMERGENCY 2 959 5 0 4 2 4 3 INDIVIDUAL PROGRAMMING 4 3 October 2001 SIGMA 0 AMELUNG TOC 1 EN KC4 AT Table of Contents 5 TEST 4 2 0 42423 5 1 5 1 INR TEE 5 1 5 2 JINR EDLOW CHART tes torn Ed eie ud ER Ce PER LN p ERR 5 3 5 3 PROTHROMBIN TIME PERCENT ACTIVITY CURVE 5 4 5 4 PT PERCENT ACTIVITY FLOW 00000000000 tene 5 7 5 5 RATIO FLOW CHARD 26 she se ate sos dan 5 8 5 6 ACTIVATED PARTIAL THROMBOPLASTIN 00 5 9 5 7 APTT FLOW CHART nina bene 5 11 5 8 FIBRINOGEN de lee eM en eu EPUM EM ER EE a 5 12 5 9 FIBRINOGEN FLOW 5 15 gt 10 FACTORS EM sn ea aa 5 16 511 FACTORS FLOW CHART areas 5 19 518 STATS m 5 20 QUALITY
20. L PRINTER FIGURE 6 1 11 1 12 PRINTER OPTIONS ns een 1 12 2 INSTALLATION ae ea ea el RO EORR 2 1 2 1 UNPACKING RERO RR 2 1 2 0 ATM COAGULATION ANALYZER START UP 9 1 2 3 LOCATION 2 2 2 2202020800000000000000 t rennen tnos 2 2 2 4 ELECTRICAL REQUIREMENTS 2 2 25 PRELIMINARY CHECK OF THE INSTRUMENT OPERATION 2 3 3 GENERAL OPERATION ini PANT EUR Rn e NOR FO a ra te 3 1 3 1 INSTRUMENT 2 00210000000000 3 1 3 2 TEMPERATURE INDICATOR SCREEN 3 1 3 8 MAIN MENU 22 2 02 0000000 0000 treten treten trennt 3 2 34 PASSWORD MODIFICATION ea 3 2 3 5 PROGRAM MODIFICATION en rn 3 3 3 6 REAGENT 222 2 0 00 0 00 0 KAKEK EEEE EEEE EEEE EEEn nanen 3 4 3 7 3 4 38 SAMPLE PREPARATION sudden con vu did un 3 5 20 HEN aio 3 6 3 10 DISPENSE SAMPLE nee 3 7 3 11 TO DISPENSE FIRST 2222222002200000 00001000000 enne 3 8 3 12 TO DISPENSE START 3 9 3 13 SELECTING A TEST 8 8 8 3 10 8 14 PATIENT IDENTIFICATION send 3 11 2 12 TESTING IA 3 11 3 16 MANUAL START PROCEDURE ep deban dd 3 12 3 17 AUTOMATIC START PROCEDURE aa 3 12 3 1
21. October 2001 4 A Introduction 1 8 Back View Figure 3 2 1 Item Function or Description 1 Thermal Printer Port Thermal Printer connection 2 Automatic Multipette Socket s Used to connect pipettes Remove the cap plug in the Multipette 3 Power Switch Powers instrument off on 4 Power Supply Socket Connects instrument to power cord October 2001 SIGMA 60 AMELU NG 1 9 EN 4 A Introduction 1 9 Multipette Figure 4 A amp B eppendort Combitip 4 Item 4 1 Volume selection dial 2 Pipetting lever 3 Filling lever 4 Locking clamp 5 Combitip 6 Combitip Cone 7 Starter Cable Multipette 4 B Function or Description Determines pipetting volume setting 1 5 multiplied by the minimum pipetting volume of the Combitip 1 25 ml or 2 50 ml pipette tips The volume is pipetted by pressing the pipetting lever down until it stops The Combitip is filled by sliding this lever upward The locking clamp serves to firmly clamp the Combitip The pipette tip used with the automatic multipette Portion of the pipette tip that aspirates reagent Connects pipette to instrument 1 10 EN SIGMA AMELUNG October 2001 4 A Introduction 1 10 Ball Dispenser Figure 5 Item Description or Function 1 Dispenser For loading microballs into cuvettes 1 11 Thermal Printer Figure 6 FRONT Paper cover Paper co
22. ROGRAM SELECTION PRINT PARAMETERS Prior to testing a Test Program or profile needs to be established The three programs available are discussed in Section 4 The Individual Program will be used here At the MAIN MENU 1 Press Program Selection 2 Enter 4 digit Password _ 3 Press lt J gt 4 Press Individual Program Modify 4 Choose tests from the keypad Press lt J gt 7 Select Yes 1 to change settings or select No 2 to leave as programmed Enter Password Press to continue Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Tests In individual program APTT New entry press ENTER J to store Press ESC to cancel Program PTT Incubation time sec 240 Max Difference 96 Modify Yes 1 No 2 October 2001 SIGMA 0 AMELUNG 5 9 EN 4 A Test Programming 8 To test in duplicate select Yes 1 or A 4 PTT program Select No 2 to test in single Double Test Yes 1 No 2 Max Difference 96 Press J to continue 9 Enter the maximum value allowed where Max difference 20 difference between values divided by the Mean value x 100 New entry press J to store Press ESC to continue Max Difference 90 10 10 Program the incubation time referenced in the test application 11 Select No 2 when modifications are complet
23. SIGMA 0 AMELUNG KC49 COAGULATION ANALYZER rum manufactured by Sigma Amelung Lemgo German y REVISION DATE 10 23 01 SIGMA DIAGNOSTICS INSTRUMENT WARRANTY Sigma Aldrich Co Inc Sigma warrants that instruments it sells to be free from defects in workmanship and materials during normal use by the original purchaser 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 Sigma Service Center immediately and be prepared to furnish pertinent details concerning the defect the model number and the serial number Warranty service is provided 8 30 a m through 5 00 p m Monday through Friday except on Sigma observed holidays 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 Sigma s labor rates then in effect This Warranty does not cover defects or malfunctions which 1 are not reported to Sigma during the Warranty Period and within one week of occurrence 2 result from chemical decomposition or corrosion 3 are described in the applicable Sigma Operation Guide 4 result from maintenance repair or modification performed without Sigma s prior written authorization or 5 r
24. 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 CV 2 05 2 86 2 12 October 2001 SIGMA 0 AMELUNG 1 5 EN 4 AT Introduction Precision Factor X Imprecision was evaluated at three levels according to the NCCLS EP5 T2 protocol Low Mid High Mean 96 31 57 102 Total Imprecision CV 8 28 5 71 5 22 Within Run Imprecision CV 2 63 2 22 2 20 Precision Factor IX Imprecision was evaluated at three levels according to the NCCLS EP5 T2 protocol Low Mid High Mean 96 24 49 98 Total Imprecision CV 5 88 6 89 4 06 Within Run Imprecision CV 3 96 4 04 2 54 1 5 Physical Description The external features of the KC4 ATM Coagulation Analyzer are shown in Figure 1 Front Figure 2 Keypad Figure 3 Rear Figure 4 Automatic Multipette with starter cable Figure 5 Ball Dispenser and Figure 6 Thermal Printer 1 6 EN SIGMA AMELUNG October 2001 4 A Introduction 1 6 Front View Figure 1 Item Rack 2 Preparation Area 3 Pipette Tubes 4 Reagent Warming Wells 5 5 Reaction Incubation Wells 8 6 Rotating Test Positions 4 7 Display Screen Function or Description Used for transferring cuvettes from preparation area to reaction incubation wells and rotating test positions Room temperature wells used for sample preparation prior to incubation Used to store the pipe
25. TOR STANDARD CURVE 65 A 5 INTRINSIC FACTORS VIII IX XI AND XII FAST TRACK A 7 INTRINSIC FACTOR STANDARD CURVE DILUTIONS A 8 October 2001 SIGMA AMELUNG A 0 EN KC4 AT APPENDIX A 1 INR Fast Track Note Use the Multipette See Section 5 for information regarding programming pL E 14 15 16 17 From the MAIN MENU press lt J gt Press RUN Select Individual Program Select lt INR gt and press lt J gt Enter Samples per rack the test must be set up for duplicates so the count would be 1 for a single sample or 2 for 2 samples Press lt J gt Enter Patient ID and press lt J gt Warm thromboplastin reagent to 37 C Place cuvettes into rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using a Tetravette Pipette 50 ul sample into bottom of each cuvette Close flap remove rack from preparation area and swirl gently 4 5 times Transfer rack into 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 Incubation Timers and then press for each channel with sample in cuvette Upon completion of incubation Timing for the last well being tested place rack into rotating test positions and open Flap Press START and begin
26. To delete all programs 6 Language Modify Parameter Check with Enter WARNING All tests in the programs and all test parameters can be deleted with one keystroke A complete new installation of programs is necessary if all programs are deleted See Section 4 for a more detailed description of Program Modification October 2001 SIGMA 60 AMELUNG 3 3 EN 4 A General Operation 3 6 Reagent Handling Reagent 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 C 0 5 C Note Reagents direct from the refrigerator may take slightly longer to warm up All reagents should be used before the expiration date listed by the manufacturer for each reagent Do not place any opened reagent bottles on the instrument 3 7 Cuvette Preparation Tetravettes or micro cuvettes are placed in racks in the unheated preparation area Up to twelve 12 cuvettes can be placed on the instrument The exact size and surface quality of the cuvettes is critical to the proper performance of testing Absolute
27. aminated control material Prepare fresh controls Incorrectly reconstituted control material s Reconstitute according to the manufacturer s instructions Use only fresh deionized 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 sequence Follow manufacturer s instructions October 2001 SIGMA 0 AMELUNG 8 3 EN 4 A Troubleshooting Symptoms Possible Causes Corrective Action Erratic within run Analytical error Perform pipette maintenance test results Imprecision in manual A pipette Operating Manual is Controls may be in pipetting of sample and included in the box of the or out of range reagent automatic pipette provided with the 4 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
28. anticoagulant to blood for patients with high gt 55 or range is inappropriate low 2196 hematocrit Unexpected results on patient samples 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 manufacturer 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 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
29. 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 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 recommended 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
30. cleanliness of cuvettes is mandatory to ensure correct performance The cuvettes are intended as one time use items Rewashing cuvettes is not recommended The performance of substitute cuvettes cannot be guaranteed therefore substitute cuvettes should not be used Tetravettes are cuvettes in pre packaged groups of 4 They contain a stainless steel ball and can go directly into a loading rack and onto the instrument The stainless steel balls 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 which are manufactured by Sigma Amelung 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 an adverse effect on coagulation testing results The balls are intended as one time use items Recycling balls is not recommended The performance of substitute balls cannot be guaranteed therefore substitute balls should not be used The ball dispenser used in conjunction with the micro cuvettes has been designed to facilitate transfer of balls into the cuvettes 3 4 EN SIGMA AMELUNG October 2001 4 AT General Operation 3 8 Sample Preparation Plasma samples and reagents are added with appropriate microliter pipettes Refer to the manufacturer s reagent
31. dispensing PT reagent into wells With the Multipette the timer starts automatically as reagent is dispensed Record results October 2001 SIGMA AMELUNG A 1 EN KC4 AT APPENDIX A 2 APTT Fast Track Note Use the Multipette See Section 5 for information regarding specific u US uet 14 15 16 17 18 programming From the MAIN MENU press lt J gt Press RUN Select Individual Program Select lt gt and press lt J gt Enter Samples per rack the test must be set up for duplicates the count would be 1 for a single sample or 2 for 2 samples Press A Enter Patient ID and press lt J gt Warm APTT reagent and CaCl to 37 C Place cuvettes into rack positioned in the unheated preparation area Dispense one ball into each cuvette if not using a Tetravette Pipette 50 ul sample into bottom of each cuvette Close flap remove rack from preparation area and swirl 4 5 times Transfer rack to heated incubation area or into the rotating test positions Incubate for 240 seconds This is the TOTAL incubation time for the test itisa combination of the sample warm up plus the warming of the APTT reagent Press to prepare Incubation Timers and then press for each channel with sample in cuvette At 185 seconds add 50 ul APTT reagent Upon completion of incubation Timing for the last well being tested place rack into rotating test positions and open flap Pr
32. e 96 Modify Yes 1 The KC4 wil automatically calculate the INR using the programmed values entered for the mean of the Reference Range and the ISI value for the thromboplastin in use Prior to entering values a reference range should be determined for the lot number of thromboplastin that will be used Because PT reference ranges can vary between laboratories and between different reagent formulations determination of the reference range on the population being served is recommended For accurate INR reporting the determination of the geometric mean is recommended When the geometric mean has been determined values may be programmed into the 4 5 2 EN SIGMA 0 AMELUNG October 2001 4 A Test Programming 5 2 INR Flow Chart Program INR Incubation Time sec Default Value ISI Value Max Difference 96 Modify 2 1 Program INR Incubation time sec New entry press J to store Press ESC to continue y INR Program Double Test Yes 1 No 2 Max Difference 96 Press to continue Program INR Default value New entry press J to store Press ESC to continue Max Difference 90 10 New entry press J to store Press ESC to continue Program INR ISI Value New entry press J to store Press ESC to continue y INR Program Doub
33. e The cycle will return to the Main Menu when all modifications are complete 5 10 EN SIGMA AMELUNG October 2001 4 A Test Programming 5 7 APTT Flow Chart Program PTT Program PTT Incubation time sec Incubation time sec 240 Max Difference Max Difference 96 10 Modify Yes 1 No 2 Modify Yes 1 No 2 PTT program Double Test Program PTT Yes 1 No 2 Incubation time sec 240 Max Difference Press J to continue Max Difference sec 10 Modify Yes 1 No 2 Max Difference New entry press J to store Press ESC to continue Next Test PTT program Double Test Yes 1 No 2 Difference Check No Press J to continue October 2001 SIGMA 60 AMELUNG 5 11 EN 4 A Test Programming 5 8 FIBRINOGEN Prior to programming Fibrinogen the concentration of the calibration curve points and the clotting time for each point must be known Allow the instrument to reach 37 C prior to testing SIGMA AMELUNG KC 4 DELTA DATE TIME 12 Sep 2001 PROGRAM SELECTION PRINT PARAMETERS Prior to testing the test must be programmed into a testing format as discussed in Section 4 The Individual Program will be used here At the MAIN MENU 1 Press for Program Selection 2 Enter 4 digit Password 3 Press lt gt 4 Press Individual Program Modify 4 5 Choose tests from the keypad
34. e the thermometer indicates operating temperature has not been reached In approximately 20 minutes the analyzer will reach operating temperature 37 0 5 C The display will change to the MAIN MENU October 2001 SIGMA AMELUNG 3 1 EN 4 A General Operation 3 3 Main Menu Functions SIGMA AMELUNG KC 4 DELTA DATE 12 Sep 2001 TIME 10 08 PROGRAM SELECTION PRINT PARAMETERS Press J to continue 1 To enter DATE select 1 The date is in European format dd mm yy 12 09 2001 is September 12 2001 The entry is confirmed with 1 or terminated with lt ESC gt If terminated the previous values remain valid 2 To enter TIME select 2 The format for time is hh mm example 10 08 3 To modify Program Selection select 3 4 To PRINT a copy of all programmed tests and parameters select 4 5 To proceed to the Operating Screen press lt I gt 3 4 Password Modification From the Main Menu screen press 3 Program Selection Password modify Routine Program modify Emergency Program modify Individual Program modify Delete all programs Language modify Press to continue Parameter Check with Enter Select 1 Password modify Enter a new password Press lt J gt The default password for a new analyzer is 1 2 3 4 Enter Password Press to continue 3 2 EN SIGMA AMELUNG October 2001 4 AT General Operation 3 5 Program Modification Selecting the te
35. e next test in the program ie APTT press lt gt Enter the number of samples per rack press lt J gt The next test in the program APTT will appear in the upper right corner of the Operating Screen To end the program press lt RUN gt Select 2 Emergency Program Enter Patient ID press lt J gt The first test programmed in the Emergency Program will appear in the upper right corner of the Operating Screen Only one sample at a time can be run in the Emergency Program At the end of the first test the result will be displayed Record the result Press lt J gt to scroll to the next test in the program To end the program press RUN Select 3 Individual Program A grid of available tests programmed into the Individual Program will be displayed see section 4 Select a test by pressing the test Function Key For example INR APTT and FIB are displayed on the grid To begin INR testing press the INR key Press lt J gt Enter number of samples per rack press lt J gt enter Patient ID press lt gt INR will be displayed in the upper right corner and the Patient ID will be displayed in the upper left corner of the Operating Screen 3 10 EN SIGMA AMELUNG October 2001 4 AT General Operation Note When entering the number of samples per rack if testing in duplicate Max would be 2 and the choice of 1 pair or 2 pair per rack would be made It is recommended that samples be analyzed in duplica
36. e password default password is 1 2 3 4 Press lt gt Select 4 Individual Program Modify press TZ Thrombin Clotting Time key Press lt gt To access the program settings press lt J gt Press 2 No until Test TZ appears at the top of the screen Press 1 Yes to modify TZ Enter 1 duplicate testing and 10 for allowed CV press lt 1 gt to continue Enter incubation time of 10 seconds press lt gt Press 2 No when modifications are done Press lt 1 gt to continue Press Run select Start Individual Program Press TZ Thrombin Clotting Time key press lt J gt October 2001 SIGMA 60 AMELUNG 2 3 EN 15 16 17 18 19 4 AT Installation Enter 2 samples per rack press lt J gt Press lt J gt again to bring the Operating Screen up If the automatic Multipette with the starter cable is being used plug the pipette cable connection into the pipette cable socket on the rear of the KC4 Snap the locking mechanism on the Multipette into place Start timers by pressing the START key followed by the individual well timers When all timers are showing 0 0 press and hold the START key While at the same time depress the trigger switch on the Multipette 4 times All wells should begin timing After at least 10 seconds remove the cuvette rack from the rotating test positions Observe that the timers stop and are indicating the elapsed time in second
37. ess START Begin dispensing 50 ul CaCl into cuvettes Using the Multipette measurement timing begins automatically Record results A 2 EN SIGMA AMELUNG October 2001 KC4 AT APPENDIX FIBRINOGEN Fast Track Note Use the Multipette See Section 5 for information regarding programming cH E O peo 11 12 14 15 16 17 From the MAIN MENU press lt J gt Press RUN Select Individual Program Select lt FIB gt and press lt J gt Enter Samples per rack the test must be set up for duplicates the count would be 1 for a single sample or 2 for 2 samples Press lt gt Enter Patient ID and press lt J gt Warm Thrombin Reagent to room temperature 18 25 C Prepare 1 10 sample dilutions Dispense one ball into each cuvette if not using a Tetravette Pipette 100 ul diluted sample patient test plasmas are prepared by diluting plasma 1 10 with Imidazole Buffer into bottom of each cuvette Close flap remove rack from preparation area and swirl gently 4 5 times Transfer rack into heated incubation area or into the rotating test positions 13 Incubate for a minimum of 60 seconds and up to a mzximum of 180 seconds Press to prepare Incubation Timers and then press for each channel with sample in cuvette Upon completion of incubation timing for the last well being tested place rack into rotating test positins and open flap Press START and begin d
38. esult from misuse abuse or accident Sigma 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 Sigma s sole discretion replacement of the instrument or of components thereof In no event shall Sigma be liable for injuries sustained by third parties incidental or consequential damages or lost profits Replaced parts shall become the property of Sigma THE FOREGOING IS THE SOLE WARRANTY MADE BY SIGMA REGARDING THE INSTRUMENT AND SIGMA SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE KC4 ATM User Manual October 2001 Software Version 1 1B O 2001 Sigma Aldrich Co October 2001 SIGMA 60 AMELUNG EN KC4 ATM Table of Contents 1 INTRODUCTION DER pH Ep MEE IH rtp E DUMP CIS 1 1 EE INTENDED USE tota 1 1 12 PRINCIPLES OF OPERATION 1 1 13 PHYSICAL SPECIFICATIONS una 1 2 1 4 PERFORMANCE SPECIFICATIONS 1 3 1 5 PHYSICAL DESCRIPTION uei eunte erroe dii unc aid aaa aa 1 6 16 FRONT VIEW FIGURE Nana 1 7 1 7 KEYPAD PURA 1 8 1 8 BACK VIEW FIGURE 3 1 9 1 9 MULTIPETTE FIGURE 4 A amp B 1 10 1 10 BALL DISPENSER FIGURE eee ele eee una eia ee 1 13 1 11 THERMA
39. eter changes to be made See Section 5 regarding programming tests Main Menu SIGMA AMELU KC 4 DELTA DATE 12 Sep 2001 TIME 10 08 PROGRAM SELECTION PRINT PARAMETERS Password Screen Enter Password Press J to continue Modify Screen Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Language Modify Parameter Check to Enter Routine Program Tests In Routine Program INR APTT FIB New entry press ENTER to store Press ESC to cancel Programming Screen Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue October 2001 SIGMA 0 AMELUNG 4 1 EN 4 A Mode Programming 4 2 Emergency Programming From the MAIN MENU Press Program Selection Enter Password press ENTER lt 1 gt to continue Press 3 Emergency Program Modify Choose tests from the keypad for this group When complete press ENTER lt J gt Tests will cycle allowing for Parameter changes to be made See Section 5 for programming changes Main menu SIGMA AMELUNG KC 4 DELTA DATE 12 Sep 2001 TIME 10 08 PROGRAM SELECTION PRINT PARAMETERS Password Screen Enter Password Press to continue Modify Screen Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Pres
40. f on switch located on the left hand side of the back of the instrument Observe that the display screen lights up a screen appears giving the operator the option to select the operating language After the language selection a screen showing a thermometer appears and will remain displayed while the instrument warms up to 37 C Observe that four of the measurement wells are rotating The wells will rotate continuously whenever the instrument is on Place a KC4 ATM 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 KC4 ATM 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 Verification of temperature can be performed by placing approximately 3 ml of water into a 15 mm reagent tube 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 3x05 Note The use of smaller diameter tubes is not recommended due to inadequate heat transfer 8 10 11 12 13 14 To verify the operation of the timers use the pipette with the start cable and the measuring wells a program modification is needed From the Main Menu select 3 Program Selection Enter th
41. film and inverting gently Do not shake Many coagulation reagents are mixtures of lipids which 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 START key Dispense reagent just to the right side of the ball and simultaneously press the Specific Channel Key Note Measurement can be started automatically if the reagent is dispensed with enough force to move the ball from its steady position This is best accomplished by dispensing the reagent directly onto the right side of the ball This dispense should not be so forceful that any of the reaction mixture is splashed out of the cuvette This is not as reliable a way to start timing It is particularly unreliable when dispensing a volume less than 100 ul 3 17 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 Install appropriately sized pipette tip Mix particulate reagent by covering the tube with Parafilm and inverting it gently Do not shake Many coagulation reagents are mixtures of lipids which will undergo spatial rearrangement when shaken The reactivity of such reagents is dependent on the specific lipid arrangement Aspirate start reagent into the
42. he KC4 ATM The KC4 ATM 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 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 October 2001 SIGMA 60 AMELU NG 7 0 EN 4 A Troubleshooting Contents 8 1 TROUBLESHOOTING FLOW DIAGRAM 8 1 8 2 TROUBLESHOOTING PROCEDURES 8 1 October 2001 SIGMA 60 AMELU NG 8 O EN 4 A Troubleshooting 8 1 Troubleshooting Flow Diagram Unexpected Results Control Results Imprecision Out 22 Sample Related Pre Analytical Error Analytical Error Reagent Related 8 2
43. ination 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 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 interface 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
44. ispensing 100 ul Thrombin Reagent into each well Using the Multipette the timer starts automatically as reagent is dispensed Record results Refer to test application October 2001 SIGMA AMELUNG A 3 EN KC4 AT APPENDIX 4 FIBRINOGEN CALIBRATION CURVE DILUTION Fibrinogen Reference Buffer Dilution ml ml Dilution Factor 157 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 4 SIGMA AMELUNG October 2001 KC4 AT APPENDIX A 5 EXTRINSIC FACTORS II V VII and X FAST TRACK Note Use the Multipette See Section 5 for information regarding programming cH E O m 11 12 13 14 15 16 17 18 From the MAIN MENU press lt gt Press RUN Select Individual Program Select FAC and press lt J gt Enter Samples per rack the test must be set up for duplicates the count would be 1 for a single sample or 2 for 2 samples Press 4 Enter Patient ID and press lt J gt Warm thromboplastin Reagent to 37 C Prepare 1 10 sample dilutions Dispense one ball into each cuvette if not using a Tetravette Pipette 50 ul diluted sample patient test plasmas are prepared by diluting plasma 1 10 with Imidazole Buffer into bottom of each cuvette Add 50 ul appropriate Factor Deficient Plasma Close flap remove rack from preparation area and swirl gently 4 5 times Transfe
45. l Program Modify 4 5 Choose tests from the keypad 6 Press lt J gt to store Enter Password Press to continue Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Tests In individual program INR New entry press ENTER J to store Press ESC to cancel October 2001 SIGMA 0 AMELUNG 5 1 4 A Test Programming 7 Select Yes 1 to change settings or select No 2 to leave as programmed 8 To test in duplicate select Yes 1 or No 2 for single testing press lt u gt 9 Enterthe maximum difference allowed where Max difference 96 difference between values divided by the mean value x 100 10 Program the incubation time referenced in the test application 11 Default Value is the PT Mean Normal 12 ISI Value for the thromboplastin in use 13 14 Max Difference as determined above Select No 2 when modification is complete The cycle will return to the MAIN MENU when all modifications are complete Program INR Incubation Time sec Default Value ISI Value Max Difference 96 Modify Yes 1 INR Program Double Test Yes 1 No 2 Max Difference 9 Press to continue Max Difference 10 New entry press 1 to store Press ESC to continue Program INR Incubation Time sec Default Value ISI Value Max Differenc
46. lashed 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 see diagram Pipette Tip Start Reagent Dispense First R irst Reagent right of ball Dispense 9 o clock Sample Dispense WU 12 o clock Bal e e 6 o clock Front View Side View October 2001 SIGMA 60 AMELUNG 3 9 EN 4 A General Operation 3 13 Selecting a Test to Begin a Run From the Main Menu Press lt J gt The Operating Screen will be displayed Operating Screen 37 C Pat ID 333 Position 1 2 3 4 Inc Time 0 0 0 0 Meas Time 0 0 0 0 Start Inc Ready 1 2 3 4 The upper left shows the current patient ID and the upper right shows the temperature of the measuring block in lt MENU gt Accesses up Main Menu functions RUN accesses the Program Menu Select 1 Routine Program Select number of samples per rack press lt J gt Enter the Patient ID press lt J gt The analyzer will display the first test programmed into the Routine Program see Section 4 For example if INR APTT and FIB are in the Routine Program then the first test to be performed will be INR INR will appear in the upper right corner of the Operating Screen replacing the temperature To scroll to th
47. le Test Yes 1 No 2 Max Difference 20 Press to continue Program INR Incubation Time sec 60 Default Value 12 2 ISI Value 1 78 Max Difference 10 Modify Yes 1 No 2 NEXT TEST October 2001 SIGMA 0 AMELUNG 5 3 EN 4 A Test Programming 5 3 Prothrombin Time Percent Activity Curve Allow the instrument to reach 37 C prior to testing SIGMA AMELUNG KC 4 DELTA DATE TIME 10 08 12 Sep 2001 PROGRAM SELECTION PRINT PARAMETERS Prior to testing a Test Program or profile needs to be established The three programs available are discussed in Section 4 The Individual Program will be used here At the MAIN MENU 1 Press 3 Program Selection 2 Enter 4 digit Password 0 3 Press lt J gt 4 Select Individual Program Modify 4 5 Choose tests from the keypad 6 Press lt gt to store Enter Password Press to continue Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Tests In individual program PT New entry press ENTER J to store Press ESC to cancel 5 4 EN SIGMA 0 AMELUNG October 2001 4 A Test Programming 7 Select Yes 1 to change settings or select No 2 to leave as programmed Program PT Incubation Time Calibration Curve PT Point 1 96 sec
48. ns for both manual start and automatic start are described below 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 October 2001 SIGMA 60 AMELUNG 3 5 EN 4 A General Operation of the ball Care must be taken to avoid splashing the reagent out of the cuvette The dispense rate should be of moderate speed and forcefulness 3 9 Pipetting The overall performance of the KC4 A Coagulation Analyzer is dependent on accuracy and precision of pipetting both sample and reagent s Testing can be performed with either standard microliter 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 microliter 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 contam
49. ogen Assure that sample has been added Reagent related No or incorrect reagent added A deficiency of Fibrinogen will greatly prolong the results of many coagulation tests Analytical error No ball in cuvette Assure that correct reagents are being used Clot formed but not detected Timer does not stop Analytical error Cuvette not seated in well Sample related Clot formed before 4 6 seconds Assure that the ball has not fallen out of the cuvette prior to insertion into measuring well Ball is positioned above the sensor Assure that there are no balls or other obstructing material in the bottom of the well 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 Parafilm is a registered trademark of American Can Company Greenwich CT October 2001 SIGMA 0 AMELUNG 8 5 EN 4 A APPENDIX Contents 1 INR FAST A 1 A2 APTT FAST TRACK siii ani A 2 FIBRINOGEN FAST TRACK A 3 A 4 FIBRINOGEN CALIBRATION CURVE A 4 EXTRINSIC FACTORS II V VII AND X FAST A 5 EXTRINSIC FAC
50. om of the cuvette Depress the pipette 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 Cuvette 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 press the button to the second stop position Sample should not Sample Dispense dispensed by touching the tip to the upper 12 o clock 6 o clock sidewalls of the cuvette Any sample that is left on the upper walls will not participate in the coagulation reaction Pipette Tip October 2001 SIGMA 60 AMELUNG 3 7 EN 4 A General Operation 3 11 To Dispense 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 pipette 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 b
51. opriate reagents the sample can be plasma or whole blood The additions of both sample and reagents are manual Time measurement of the clotting endpoint is automated 1 2 Principles of Operation The A is an electromechanical clot detection system 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 AM The measuring well rotates slowly 50 rpm 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 position and triggers an impulse in the magnetic sensor This impulse electronically stops the timer see diagrams Cuvette Stainless Thermostatically Steel Controlled Ball Incubation Block a Magnetic Sensor Precision Drive gt October 2001 SIGMA 60 AMELUNG 1 1 EN 4 AT Introduction 1 3 Physical Specifications Type Online Principle Measuring Channels Display Incubation Wells Reagent Wells Dimensions Height Width Depth Weight
52. or to using the KC4 A Coagulation Analyzer The Operation Manual has been written to provide the most comprehensive understanding of the operation of the KC4 ATM Coagulation Analyzer and to enable you to fully utilize the features of the instrument 2 3 Location Requirements 1 Place the KC4 ATM 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 KC4 ATM Coagulation Analyzer should also be protected from moisture 2 To avoid exceeding the control range of the instrument place the KC4 ATM Coagulation Analyzer 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 KC4 ATM Coagulation Analyzer to direct sunlight Sunlight influences the temperature control 3 Itis preferable to place the KC4 ATM Coagulation Analyzer in an area which is no further than 6 ft 1 8 m from an electrical outlet The instrument should 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
53. printer will immediately print out the results of the first test The second test results will be printed after lt J gt is pressed Individual Program INR Date 25 Nov 2001 Time 01 11 Patient ID 25 Measured Values Value 1 12 4 sec Value 2 12 1 sec Average Value 12 25 sec Difference 2 4 Result 1 02 Individual Program INR Date 25 Nov 2001 Time 01 12 Patient ID 26 Measured Values Value 1 12 0 sec Value 2 12 3 sec Average Value 12 15 sec Difference 2 4 Result 1 01 Individual Program INR Date 25 Nov 2001 Time 01 14 Patient ID 27 Measured Values Value 1 11 5 sec Value 2 11 2 sec Average Value 11 35 sec Difference 2 6 Result 0 93 October 2001 3 13 EN SIGMA 0 AMELUNG 4 AT Mode Programming Contents 4 1 ROUTINE 4 1 4 2 EMERGENCY 222 4 2 4 3 INDIVIDUAL PROGRAMMING 4 3 October 2001 SIGMA AMELU NG 4 0 EN 4 AT Mode Programming 4 1 Routine Programming From the MAIN MENU Select 3 Program Selection Enter Password press ENTER lt 1 gt Press 2 Routine Program Modify Select from the keypad all tests desired for this group When complete press ENTER lt 1 gt Tests programmed will cycle allowing param
54. pt 30 749 0 166 3 403 The following linear regression data was obtained in three physician s office laboratories POL during evaluation to show equivalence with manufacturer derived results on the KC4 Coagulation Analyzer Activated Partial POL 1 Prothrombin Time Thromboplastin Time Number of Samples 47 44 Correlation Coefficient 0 991 0 960 Slope 0 981 1 066 Intercept 0 492 0 379 Activated Partial POL 2 Prothrombin Time Thromboplastin Time Number of Samples 45 46 Correlation Coefficient r 0 989 0 965 Slope 1 019 1 029 Intercept 0 248 1 021 October 2001 SIGMA 60 AMELUNG 1 3 EN 4 AT Introduction Activated Partial POL Prothrombin Time Thromboplastin Time Number of Samples 52 47 Correlation Coefficient 0 974 0 927 Slope 1 012 0 786 Intercept 0 326 9 470 Precision Prothrombin Time PT Imprecision was evaluated at three levels according to NCCLS EP5 T2 protocol Low Mid High Mean seconds 13 20 33 53 39 66 Total Imprecision CV 2 03 2 50 4 18 Within Run Imprecision CV 1 02 1 28 1 53 PT total imprecision was evaluated in three physician s office laboratories POL at three levels according to NCCLS EP10 T protocol Within Run imprecision was evaluated three physician s office laboratories at two levels POL 1 Low Mid High Mean seconds 13 1 26 8 42 9 Total Imprecision CV 1 97 1 63 2 47 Mean seconds 12 7 44 1 Within Run Imprecision CV
55. r rack into heated incubation area or into the rotating test positions Incubate for a minimum of 60 seconds and up to a maximum of 180 seconds Press to prepare Incubation Timers and then press for each channel with sample in cuvette Upon completion of incubation timing for the last well being tested place rack into rotating test positions and open flap Press START and begin dispensing 100 ul thromboplastin into each well Using the Multipette the timer starts automatically as reagent is dispensed Record results Refer to test application October 2001 SIGMA AMELUNG A 5 EN KC4 AT APPENDIX A 6 EXTRINSIC FACTOR STANDARD CURVE DILUTIONS Reference Dilution Plasma ml 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 6 EN SIGMA 0 AMELUNG October 2001 KC4 AT APPENDIX 7 INTRINSIC FACTORS VIII IX and XII FAST TRACK Note Use the Multipette See Section 5 for information regarding programming 12 13 14 15 16 17 19 20 From MAIN MENU press lt gt Press RUN Select Individual Program Select FAC and press lt J gt Enter Samples per rack the test must be set up for duplicates the count would be 1 for a single sample or 2 for 2 samples Press lt gt Enter Patient ID and press lt J gt
56. ram FAC New entry press ENTER J to store Press ESC to cancel 5 16 EN SIGMA 0 AMELUNG October 2001 4 A Test Programming 7 Select Yes 1 to change settings or select No 2 to go to the next test 8 To test in duplicate select Yes 1 or No 2 for single 9 Enter the maximum difference allowed where Maximum value 96 difference between values mean value x 100 10 Press lt J gt to continue PROGRAM FAC Factor 0 Incubation Time sec Count Points Calibration Curve F Point 1 96 0 0 sec 0 0 Point 2 96 0 0 0 0 Point 3 96 0 0 sec 0 0 Modify Yes 1 No 2 next test FAC Program Double Test Yes 1 No 2 Max Difference Press to continue Max Difference 0 New entry press J to store Press ESC to continue FAC Program Double Test Yes 1 No 2 Max Difference Press to continue Note Only one factor curve may be entered at a time October 2001 SIGMA 60 AMELUNG 5 17 EN 11 13 14 15 16 17 4 A Test Programming Enter the Factor that will be used 12 Enter an incubation time referenced in the test application Choose as many Curve Points Count Points as appropriate for testing requirements 9 points max Enter the reference value of the Factor calibration curve This is the first point the highest point of the curve This does not al
57. rence value of the P FIB P FIB Fibrinogen reference plasma in G L M Ld for the first point of the curve This Incubation Time sec Incubation Time sec can vary depending on the source Calibration Curve FIB Calibration Curve FIB of the reference plasma When Point 1 G L Point 4 G L using the KC4 ATM Coagulation d Analyzer care should be taken that the clot time of the highest point is 5 Port gt G1 more than the minimum read time sec sec 4 5 sec of the instrument This Point 3 G L Dilution 1 5 can be achieved by utilizing the sec Difference Check FIB No optimal dilutions for the reference plasma referred to in the reagent applications Dilution Modify 1 No2 Max Difference Modify Yes 1 No2 Enter the clotting time in seconds for the first point of the Fibrinogen reference curve Enter the second value for the Fibrinogen reference curve The second point is a dilution of the reference plasma Enter the clotting time in seconds for the second point of the Fibrinogen reference curve Enter the third value for the Fibrinogen reference curve The third point is a dilution of the reference plasma Enter the clotting time in seconds for the third point of the Fibrinogen reference curve Enter the fourth value of the Fibrinogen reference curve The fourth point is a dilution of the reference plasma Enter the clotting time in seconds for the four
58. rve FIB Calibration Curve FIB Point 1 G L Point 4 G L New entry press J to store sec sec Press ESC to continue Point 2 G L Point 5 G L sec sec Point 3 G L Dilution 1 5 FIB program sec Difference Check FIB No Double Test Dilution Modify Yes 1 No2 Yes 1 No 2 Difference Check FIB No Max Difference Modify Yes 1 No2 Press J to continue gt NEXT TEST October 2001 SIGMA 60 AMELUNG 5 15 EN 4 A Test Programming 5 10 FACTORS Prior to programming Factors the concentration of the calibration curve points must be known and the clotting time for each point must be established Allow the instrument to reach 37 C prior to testing SIGMA AMELUNG KC 4 DELTA DATE TIME 10 08 12 Sep 2001 PROGRAM SELECTION PRINT PARAMETERS Prior to testing a Test Program or profile needs to be established The three programs available are discussed in Section 4 The Individual Program will be used here At the MAIN MENU 1 Press 3 Program Selection 2 Enter 4 digit Password 3 Press lt J gt 4 Select Individual Program Modify 4 5 Choose desired tests from the keypad 6 Press lt J gt Enter Password Press to continue Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Tests In individual prog
59. s ENTER to continue Emergency Screen Tests In Emergency program INR APTT FIB New entry press ENTER to store Press ESC to cancel Programming Screen SIGMA AMELUN KC 4 DELTA DATE 12 Sep 2001 TIME 10 08 PROGRAM SELECTION PRINT PARAMETERS 4 2 EN SIGMA 0 AMELUNG October 2001 4 A Mode Programming 4 3 From the MAIN MENU Press Program Selection Enter Password press lt 1 gt Press 4 Individual Program Modify Choose tests from the keypad for this group When complete press ENTER lt gt When complete press ENTER lt 1 gt Tests will cycle for parameter changes See Section 5 for programming information Individual Programming Main Menu SIGMA AMELU KC 4 DELTA DATE 12 Sep 2001 TIME 10 08 PROGRAM SELECTION PRINT PARAMETERS Password Screen Enter Password Press J to continue Modify Screen Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue Individual Screen Tests In Individual Programming INR APTT FIB New entry press ENTER to store Press ESC to cancel Programming Screen Password Modify Routine Program Modify Emergency Program Modify Individual Program Modify Delete all programs Press ENTER to continue October 2001 SIGMA 0 AMELUNG 4 3 EN 4 A Test Programming Contents S L INR sd
60. s and tenths of seconds The first result will print automatically if the optional printer has been installed or will appear on the screen Press lt J gt to print the second result and clear the memory With the completion of the Preliminary Checks of Instrument Operation installation is complete and the instrument is ready for operation If the instrument fails to perform any of the tests with the specifications listed call Sigma Diagnostics Technical Service for assistance 2 4 EN SIGMA 0 AMELUNG October 2001 4 AT General Operation Contents 3 1 INSTRUMENT 3 1 3 2 TEMPERATURE INDICATOR 3 1 3 3 MAIN MENU 8 2 4 3 2 3 4 PASSWORD MODIFICATION 3 2 3 5 PROGRAM 3 3 3 6 REAGENT 2 3606 3 4 3 7 CUVETTE PREPARATION 3 4 3 8 SAMPLE PREPARATION 3 5 8 9 PIPETTING see 3 6 3 10 TO DISPENSE
61. sts to be available for each program The programs Routine Emergency Individual are modified by selecting tests from the keypad to form a desired group From the Main Menu screen select 3 Program Selection From the Program Selection screen select 2 Modify the Routine Program 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 FIB etc and confirming with lt J gt 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 3 Modify the Emergency Program This function allows the operator to select the tests available to be run in the Emergency Program The tests are selected by pressing keys INR APTT FIB etc and confirming with lt gt Terminating is possible with lt ESC gt Upon termination the previously set values will remain valid The analyzer will do a selected profile of tests on a single patient Patient Selective 4 Modify the Individual program 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 Terminating is possible with lt ESC gt Upon termination the previously set values will remain valid 5
62. te Samples per rack Count 2 2 3 14 Patient Identification After the number of samples per rack has been entered the analyzer will ask for a Patient ID number Press 1 to enter a Patient ID The instrument will automatically increment up from this number Press 2 to enter a specific Patient ID for the samples to be analyzed Note This screen must be re accessed to enter subsequent Patient ID numbers To do this press the RUN key select 3 Individual Program Press the appropriate test key Theer the number of samples per rack 2 when analyzing in duplicate select 2 for manual Patient ID entry ROUTINE PROGRAM Patient ID Start Patient ID Modify Manual Patient ID Press to Continue 3 15 Testing 1 With the transfer of the first rack to the rotating wells Press Incubation timer Operating Screen Patient ID 333 INR Position 1 2 3 4 Inc Time 0 0 0 0 Meas Time 0 0 0 0 0 0 0 0 Start Inc une READY 2 Press Channel timer for each sample to be tested October 2001 SIGMA 60 AMELUNG 3 11 EN 4 A General Operation 3 Each channel will begin the incubation countdown An audible beep will occur when 5 seconds remain 4 Press and hold down the START key and begin dispensing start reagent 3 16 Manual Start Procedure Install a pipette tip onto an appropriately sized pipette Mix particulate reagent by covering the tube with Para
63. th point of the Fibrinogen reference curve Enter the fifth value of the Fibrinogen reference curve The fifth point is a dilution of the reference plasma Enter the clotting time in seconds for the fifth point of the Fibrinogen reference curve Enter the dilution for the patient or control samples to be analyzed Fibrinogens use a 5 point reference curve Select No 2 when modifications are complete The cycle will return to the Main Menu when all modifications are complete Note Suggested dilutions and volumes used are found in the KC4 AM Fibrinogen Application 5 14 EN SIGMA AMELUNG October 2001 4 A Test Programming 5 9 Fibrinogen Flow Chart Program FIB Incubation time sec Program FIB Incubation Time sec New entry press J to store Calibration Curve FIB Press ESC to cancel Point 1 G L sec y Point 2 G L A Program FIB Calibration curve FIB sec Point 3 G L sec New entry press J to store Press ESC to cancel Y Dilution Max Difference 0 Program FIB Modify Yes 1 Point 1 G L New entry press J to store FIB program Press ESC to cancel Double Test Yes 1 No 2 Continue through all parameters of the program Max Difference Press J to continue Program FIB Program FIB Max Difference 96 Incubation Time sec Incubation Time sec Calibration Cu
64. 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 combitip 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 3 6 EN SIGMA AMELUNG October 2001 4 AT General Operation 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 10 Dispense 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 bott
65. tion curve sec Point 2 90 sec Point 96 sec PT MAX 96 Max Difference 10 Modify Yes 1 No2 15 Enter the third value of the PT calibration curve The third point the lowest point of the curve is a dilution of the reference plasma Program PT Incubation Time sec Example 12 5 is used Calibration Curve E 16 Enter the clotting time in seconds of the third Point ii point of the PT calibration curve sec 17 Enter the Maximum PT value Values exceeding maximum value sec entered are not printed out Point 00 Example 130 is used sec PT MAX Max Difference 10 Modify Yes 1 No2 18 Select No 2 when modification is complete The cycle will return to the MAIN MENU when all modifications are complete 5 6 EN SIGMA AMELUNG October 2001 4 AT Test Programming 5 4 PT Percent Activity Flow Chart Program PT NEXT TEST Incubation Time gt Calibration Curve PT 7 Program PT Point 1 96 Incubation Time sec 60 sec Calibration Curve PT Point 2 96 Point 1 96 sec sec Point 3 96 Point 2 96 sec sec PT MAX 96 Point 3 96 Difference Check PT No sec Modify Yes 1 No2 PT MAX Max Difference 96 Modify Yes1 No2 PT Program Double Test Yes No 2 Max Difference 96 NEXT TEST Press to continue Max
66. 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 Reagent related Reagent deterioration caused by extended heating in reagent well Reconstitute new reagent and or control material Reagent related Reagent concentration caused by evaporation Remove reagent from instrument at the completion of testing 8 4 EN SIGMA AMELUNG October 2001 4 A Troubleshooting Symptoms Possible Causes Corrective Action continued Erratic within run test results Controls may be in or out of range Sample related Improper specimen collection and handling Reagents should be capped when not in use Check sample integrity looking for microclots hemolysis 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 Sample related No sample added Observe recommended sample storage conditions No clot formation Sample related Low fibrin
67. ttes when not in use Three 15 mm and two 11 mm heated wells used to warm reagents Heated wells used for incubation of sample and first reagent Positions where start reagent is added and the clotting time is measured Displays elapsed time in seconds during incubation for each of 4 channels Displays elapsed time in seconds and tenths of seconds during clot time measurement Displays incubation times clotting times programming selections and other menus October 2001 SIGMA 60 AMELU NG 1 7 EN 4 A Introduction 1 7 Keypad Figure 2 Item 1 Start Key 2 Incubation Key 3 Ready Key 4 Channel Key 5 Stop Key 6 Function Keys 7 Menu Key 8 Run Key 9 4 10 ESC Key 11 Printer Key 12 Dilution Key 13 DEL key FS ES gt 1 2 No gt A sap JJ 4 x j Function or Description Activates automatic measurement timer Starts Incubation timers Not functional at this time Starts manual timing and incubation Terminates measurements and aborts testing Used in programming tests Returns to Main Menu from Operating Screen Returns to Test Program Selection Screen from Operating Screen ENTER Escapes back to previous function Used to turn printer on or off Used to change the patient dilution 1 8 EN SIGMA AMELUNG
68. utton 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 submersed 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 previously dispensed sample First Reagent Sample Dispense Dispense 12 o clock 9 o clock 8 Ball i First Reagent Dispense 9 o clock Front View Side View 3 8 EN SIGMA AMELUNG October 2001 4 AT General Operation 3 12 To Dispense Start 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 pipette 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 pipette button to the last stop position The dispense rate should not be so rapid or forceful that reagent is sp
69. ver window Power Switch BACK Serial input Parallel input connector Power supply jack Ground screw October 2001 SIGMA 60 AMELUNG 1 11 EN 4 AT Introduction 1 12 Printer Options From the Main Menu press lt I gt Press the PRINTER key The shows which options have been selected If the analyzer is connected to a host LIS ensure that option 4 is selected If the analyzer is not connected to a host LIS select 5 Print Test Page Print Switch On Print Switch Off Line out incl Error Val 4 5 Line out excl Error Val Press ENTER lt J gt to continue 1 12 EN SIGMA0AMELUNG October 2001 4 A Installation Contents EE Vie dnce 2 1 2 2 KC4 A COAGULATION ANALYZER START UP KIT 2 1 2 3 LOCATION 5 00 00 0 2 2 2 4 ELECTRICAL 65 2 2 222 2 2 2 5 PRELIMINARY CHECK OF THE INSTRUMENT 2 3 October 2001 SIGMA 0 AMELU NG 2 0 EN 4 AT Installation 2 1 Unpacking The 4 A 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 Sigma Diagnostics Sales Representative 2 2 4
70. ways have to be 100 it can vary depending on the source of the reference plasma Enter the clotting time in seconds of the first point of the Factor calibration curve Continue entering percentage points and seconds to complete the calibration curve PROGRAM FAC Factor 0 Incubation Time sec Count Points Calibration Curve F Point 1 96 sec Point 2 96 0 0 sec 0 0 Point 3 96 0 0 sec 0 0 Modify Yes 1 No 2 next test Select No 2 when modifications are complete The cycle will return to the Main Menu when all modifications are complete 5 18 EN SIGMA 0 AMELUNG October 2001 4 A Test Programming 5 11 Factors Flow Chart PROGRAM FAC Factor 0 Program FAC Incubation Time sec Incubation time sec Count Points Calibration Curve F 2 New entry press J to store Point 1 0 0 Press ESC to cancel through remaining parameters sec 0 0 Point 2 0 0 sec 0 0 After final parameter has been entered Point 3 0 0 sec 0 0 Modify Yes 1 No 2 next test PROGRAM Factor 0 FAC Program Incubation Time sec 2 Double Test Count Points Yes 1 No 2 Calibration Curve F Point 1 94 0 0 Max Difference sec 0 0 Press ENTER to continue Point 2 96 0 0 sec 0 0 Point 3 0 0 Max Difference sec 0 0 New entry press to store Press ESC to continue Modify Yes 1 No 2 next test FAC

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