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Labitec CoaDATA 501 Скачать руководство пользователя страница 53

 

Appendix 

 

CoaDATA 501 – Operators Manual 2.1 

Page 51 

Calibration curve axes 

PT: reciprocal/linear
Fibrinogen: log/log 
Extr. Factor 

log/log 

Intr. Factor 

log/log 

 
 

Conversion to ratio  
and INR: 

ratio

 

= measured clotting time / normal value 

 

INR

 = RATIO

 

ISI

 

 (International Normalized Ratio) 

 

ISI 

=

 

International Sensitivity Index according to package insert 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Содержание CoaDATA 501

Страница 1: ...Operators Manual CoaDATA 501 For in vitro diagnostic use only...

Страница 2: ...following LABiTec Software is the intellectual property of the LABiTec LAbor BioMedical Technologies GmbH Intellectual property rights shall remain with LABiTec LAbor BioMedical Technologies GmbH You...

Страница 3: ...meterization 28 2 2 5 Thrombin time parameterization 28 2 2 6 Intrinsic Factor parameterization 28 2 2 7 Extrinsic Factor parameterization 28 2 2 8 Utilities 29 2 2 8 1 Menu printer 29 2 2 8 2 Menu co...

Страница 4: ...Contents CoaDATA 501 Operators Manual 2 1 Page 2 5 APPENDIX 47 5 1 Disposables 47 5 2 Materials Supplied 47 5 3 Technical Data 48 5 4 Safety Specifications 49 5 5 Mathematics 50 5 6 Terminology 52...

Страница 5: ...is accessed with the Mode key Any procedure can be cancelled or stopped with the Esc key The measuring channel is integrated into the 37 4 C incubation block with 1 position for reagent bottle and 4...

Страница 6: ...ation block 37 C 4 positions for cuvettes T position for temp adjustment 1 position for reagent bottle 1 measuring channel with light protection caps designed for Thrombi Tips Membrane keypad with key...

Страница 7: ...nter parameters 0 key A print out of the respective parameters for the selected method is generated by pressing 0 during measuring Mode key 1 Calibration 2 Menu selection analyzer settings and method...

Страница 8: ...and centrifuges Use only the included original AC power adapter Use only original cuvettes and stir bars which will assure proper operation of the instrument Switch on CoaDATA 501 Connect the externa...

Страница 9: ...ed into the appropriate units ratio INR mg dl g l Once the start reagent has been added the measuring channel is adjusted that is the lamp intensity automatically adjusts up or down depending on the t...

Страница 10: ...analyzer is equipped with light protection caps for Thrombi Tips To guarantee perfect functioning of the system it is absolutely necessary to use only the variable Thrombi Pette and original Thrombi...

Страница 11: ...display will show the 36 5o C actual temperature of the measuring block 14 26 the remaining time of warm up phase The analyzer requires approximately 30 minutes to warm up the incubation block to an...

Страница 12: ...last e g PT is selected 1 PT Printer If the printer is set to AUTO in the menu UTILITIES the parameterization of the selected method as well as the result of the first measurement is printed as soon a...

Страница 13: ...cuvette Immediately place this cuvette into measuring channel Close the light protection cap The analyzer automatically recognizes the cuvette and starts the timer for sample incubation timer count d...

Страница 14: ...be adjusted for sample adjS adjust Sample adj S2 Sample adjustment Once the sample has been adjusted the following display 100 ul alternately GO S2 appears 100 ul Request to add GO S1 add start reage...

Страница 15: ...p Remove cuvette from measuring channel and confirm by pressing Reset key see chapter 3 Software The analyzer is now ready for additional measurements cuv in 1 Continue as described for additional mea...

Страница 16: ...rs Manual 2 1 Page 14 Select the desired method 1 7 Press Enter to confirm the method selection The new method has been initialized Incubation of the first samples can begin cuv in 1 Continue as descr...

Страница 17: ...CARD Reader the method name and the lot no will be displayed automatically reading card aPTT Lot XXXXX Press Enter to confirm loading remove card When remove card is displayed remove the ChipCARD from...

Страница 18: ...ber has been entered the following display will appear 1 conv Press the arrow key to display the following menus 1 conversion 2 conversion replication measurement and cuv remove detec Overview PT para...

Страница 19: ...n the first calibration point This point is defined as point of greatest activity and shortest clotting time 1 point 100 0 Confirm the activity of 100 0 by pressing Enter or overwrite the preset entri...

Страница 20: ...st is active for con versions in the ready to measure mode This is also valid for INR and ratio under 2nd conversion Press Esc to access the measuring mode or Enter to add or verify additional paramet...

Страница 21: ...replication you can select between double for double determinations or single for single determinations by pressing the arrow key replic Press Enter double Selection of double determination Press Ent...

Страница 22: ...t reagent volume and lot number appears Start reagent volume reagent lot number Start Reagent 100 ul Enter the volume for the start reagent e g 100 l Press Enter to confirm the entry lot no 12345678 E...

Страница 23: ...measuring channel OFF Cuvette detection occurs only when a cuvette is placed into the measuring channel The removal of cuvettes must be confirmed by pressing the Reset key Select the desired cuvette...

Страница 24: ...by pressing the right arrow key Overview over aPTT parameterization 2 conversion ratio input of normal value for ratio calculation or none for no conversion replication select single or double determi...

Страница 25: ...oefficient of variation of the individual values will be displayed If this value is exceeded the message mean error will appear in the display and print out coef variat ion possible entry range n 5 1...

Страница 26: ...r key to get the cuvette detection on the display OFF By selecting ON Cuvette detection occurs as soon as a cuvette is placed in the measuring channel or removed from the measuring channel OFF Cuvette...

Страница 27: ...e and the coefficient of variation double CV 1 20 measurement start reagent volume reagent lot no and sample incubation time cuv remove detect refer to chapter 3 Software ON activates the automatic cu...

Страница 28: ...ion curve point has been confirmed select ESC work ENTER more parameters Press Esc to access the measuring mode or Enter to add or verify additional parameters replication replic Press Enter double Se...

Страница 29: ...entry of start reagent volume and reagent lot no Start Reagent 100 ul Enter the volume for start reagent lot no 12345678 Enter the reagent lot no Press Enter to confirm the selection select ESC work E...

Страница 30: ...parameterized with this menu intrinsic factors endogenous clotting factors The following menus can be accessed under method parameters 1 conversion curve input of a 9 point calibration curve under or...

Страница 31: ...ate and time calibrate temp adjustment of temperature secret no enter personal secret number cuvette test test automatic cuvette detection Use the left or right arrow key to change the menu selection...

Страница 32: ...e of the distributor 2 2 8 3 Menu beeper beeper Press Enter to confirm selection The integrated beeper provides an acoustic signal during key strokes when an error occurs after sample incubation when...

Страница 33: ...f the incubation block Refer to chapter 1 2 figure 1 marked with T If you like to verify or adjust the temperature the cuvette at the position T must be filled with 400 l bi distilled water Measuring...

Страница 34: ...he following display will appear enter new se cret no 11111 0 none You can overwrite the number preset by the manufacturer Press Enter to save the new number A print out of secret number as well as se...

Страница 35: ...measuring channel the display cuv appears The display will show the respective status once a cuvette is placed into or removed from the analyzer Press Enter to leave the menu 2 3 Printer It is possibl...

Страница 36: ...2 8 Utilities PARAMETER PROTOCOL 980 Bytes 1 channel V X xx mm dd yy math vers V XX xx actual date time 02 12 99 14 44 00 dd mm yy hh mm ss device specific ser no j582074 Serial number of analyzer sec...

Страница 37: ...UBLE Double determination coef var 5 Coefficient of variation incubat 60 s Sample incubation time start reagent Lot 101xxx Reagent lot no reagent 100 ul Reagent start volume 1st convers INTERPOLAT 1 c...

Страница 38: ...coef var 5 Coefficient of variation incubat 60 s Sample incubation time start reagent Lot 101xxx Reagent lot no reagent 100 ul Reagent start volume 1st convers QUICK FACTOR 2nd convers INR 100 11 8s f...

Страница 39: ...ipets The pipetting process was too slow and the angle incorrect The temperature of the start reagent deviates from 37 C The reagent has been placed incorrectly The sample or control is too old No sti...

Страница 40: ...cal Service break readjust message is displayed if the light value is too dark during the adjustment phase Repeat test and dilute plasma if necessary mg dl 2 0 converted value is lower than the parame...

Страница 41: ...om the set value the measurement is not cancelled Instead this warning appears in the display and is also printed out via the active printer mean error Signals a wrong result after a double determinat...

Страница 42: ...following menus printer computer beeper clock calibrate temp secret number and cuvette test The analyzer contains automatic cuvette detection The following display will appear after initialization aut...

Страница 43: ...eep channels clear 1 PT Method parameter Test steps double determ Method list secret no cuv in 1 1 PT 1 conv incu 47 2 aPTT 2 conv adj S1 3 Fib 1 replic GO S1 4 Fib 2 measure 100 ul 5 Thrmb cuvdet 1 2...

Страница 44: ...ow chart to set single or double determination at the analyzer Test steps for double determination Test steps for single determination cuv in 1 cuv in incu 47 incu 47 adj S1 adj S GO S1 GO S 100 ul 10...

Страница 45: ...time 0 0 0 0 0 0 0 0 0 sec 3 Fib 1 Value 8 4 2 1 0 0 0 0 0 g l 0 0 0 2 Time 8 5 16 5 32 80 0 0 0 0 0 sec 4 Fib 2 Value 804 402 199 100 0 0 0 0 0 mg dl 0 0 0 3 Time 8 5 16 5 32 80 0 0 0 0 0 sec 5 Thrmb...

Страница 46: ...electrical shock as low as possible Use only grounded extension cables Never intentionally disconnect the grounding contacts There is the risk of electrical shock if the protective conductor is interr...

Страница 47: ...ximity of the analyzer Electrical sparks could cause fire or explosions 3 Mechanical safety Analyzer is operating Never open screw attached housing parts while the instrument is ON There is a risk of...

Страница 48: ...functions significantly Keep the instrument clean and do not spill liquids onto the analyzer To protect the instrument from dust cover it with the supplied dust cover or store instrument in a cabinet...

Страница 49: ...al CoaDATA 501 30 000 1613 German Version Pipettes Thrombi Pette 20 200 l 20 000 2712 Thrombi Pette 20 l 20 000 2713 Thrombi Pette 50 l 20 000 2714 Thrombi Pette 100 l 20 000 2715 Thrombi Pette 200 l...

Страница 50: ...lume min 150 l max 300 l test suspension Calibration manual input of calibration points method dependent Software loaded in memory Programmed PT in sec Ratio INR combinations methods aPTT in sec and R...

Страница 51: ...th the essential requirements of the following European directives If the instrument s type plate bears an IVD symbol it complies with the following directive 98 79 EC in vitro Diagnostics directive I...

Страница 52: ...le 57 Computation of PT 1 meas time 100 PT Range for conversions Method Unit from to exceeded PT 2 0 250 error Ratio 0 1 10 Error INR 0 1 10 error Fibrinogen g l 0 4 9 999 error mg dl 40 999 9 error A...

Страница 53: ...e axes PT reciprocal linear Fibrinogen log log Extr Factor log log Intr Factor log log Conversion to ratio and INR ratio measured clotting time normal value INR RATIO ISI International Normalized Rati...

Страница 54: ...clock menu date and time curve calibration curve cal calibration adjustment cuvette test automatic cuvette detection cuv lrn blank value cuvette detection cool down refer to chapter 2 4 4 D E ERROR r...

Страница 55: ...Pro parameter protocol parameter error refer to chapter 2 4 2 Q R S Secret no security code number T THROMBIN T Thrombin time TIME hour minute second Temperat warning refer to chapter 2 4 4 SYSTEM FAI...

Страница 56: ...Appendix CoaDATA 501 Operators Manual 2 1 Page 54...

Страница 57: ......

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