Itc ProTime Microcoagulation System User Manual Page 1

ProTime® Microcoagulation System For in vitro Diagnostic Use Operator’s Manual TABLE OF CONTENTS INTENDED USE...

10 Charging the Battery The battery in the instrument needs to be charged before the first use. 1. Connect the AC/DC power module to an electrical ser

11 3. Prepare for Finger Incision While the cuvette is warming, prepare the finger. Wait for the prompt before incising the finger and collecting blo

12 • Touch the large drop of blood to the collection cup. Keep adding blood until the blood level fills the cup above the line. • For Tenderlett Plu

13 • It takes only a few seconds for ProTime to draw the blood into the cuvette. Watch the screen for the next prompt. 7. Remove Tenderlett Plus

14 8. Read the Result In a few minutes, the result is ready. • Press the button to turn off. • Press the button to go to the MAIN MENU i

15 Troubleshooting Guidelines • Become skilled at obtaining blood with the fingerstick technique. This will help avoid sample errors. • Follow all o

16 Screen Display Source of Error Method of Control CUVETTE EXPIRED Expired cuvette Check to make sure cuvettes have not expired. The expiration d

17 Run Test To run the test, select the RUN TEST menu item. The instrument does a SELF CHECK procedure, which may take up to 60 seconds. The followin

18 RUN LQC When RUN LQC is selected from the MAIN MENU, the following screen is displayed and the user can select NOR/ABN (NORMAL/ABNORMAL). The ins

19 SHOW RESULTS Press the button to move the highlight bar to the SHOW RESULTS line on the MAIN MENU. Press the button to view the SHOW RESULTS me

2 INTENDED USE The ProTime Microcoagulation System is a portable, battery-operated instrument with a disposable cuvette for quantitative determination

20 LQC RECORDS The result and ID information will be stored in the database as a QC record. QC result will be displayed as follows, depending upon

21 The instrument auto send feature allows transmitting of test results directly to a serial printer or to a computer by using the PROCABLE. Contact

22 SET UP Go to the MAIN MENU screen and choose the SET UP option by using the button to scroll and the button to select SET UP. The following scr

23 Changing the Hour The time is pre-set to Eastern Standard Time (EST). For example, the time is 1:25 PM. Change the hour by pressing the button u

24 SET PID/OID The PID/OID selection is indicated only by the location of the highlight (text on the screen is unchanged). • Use the button to selec

25 To enter a PID, the first position in the PID field (starting from the left) is indicated by a triangular cursor. • Press the button until the de

26 The CONFIRM PID confirmation screen will follow the ENTER PID screen: After setting of both requested PID and/or OID, the WARMING screen will appe

27 FOR PROFESSIONALS ONLY - PROGRAM MODE Note: The Program Mode feature is only available to professional users. The following information is not c

28 Once the correct month appears, press the button to set the month. The procedure will then advance to changing the year screen. Change the year

29 SET ISI If SET ISI is selected from the PROGRAM MODE, the following screen is displayed: To change the ISI used in the calculation, access the PRO

3 SYSTEM FEATURES 1. Tenderlett Plus/Tenderlett Plus LV. The finger incision and blood collection device used with ProTime and ProTime cuvettes.

30 CHANGE PASSWORD If CHANGE PASSWORD option is selected from the PROGRAM MODE menu, the user must enter the password (up to 6 digits) as a left just

31 PERFORMANCE CHARACTERISTICS Reporting ProTime Results The ProTime Microcoagulation System reports a result as International Normalized Ratio (INR)

32 Table 2 shows examples of how the calculation of PT seconds is affected by changing the ISI. As the ISI increases, the plasma equivalent PT decreas

33 Accuracy INR results generated by the ProTime and ProTime3 cuvettes using venous and fingerstick whole blood samples were compared to INR values o

34 Additional external control materials may be used to check instrument function, reagent integrity and user technique. Each institution should esta

35 SUGGESTED READING Adcock DM, Kressin DC, Marlar RA. Effect of 3.2% vs 3.8% Sodium Citrate Concentration on Routine Coagulation Testing. Am J Clin

36 SAFETY STANDARDS The ProTime instrument complies with the following safety standard requirements and directives: CSA C22.2. 601.1. Medical Electr

37 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The ProTime® Microcoagulation System is intended for use in the electromagneti

38 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The ProTime® Microcoagulation System is intended for use in the electromagnetic

39 INDEX attention label ...4 battery care...8 b

4 IMPORTANT LABELS AND SYMBOLS Before using the ProTime Microcoagulation System, it is essential that the contents of this Operator’s Manual and any i

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5 PRINCIPLES OF OPERATION The ProTime Microcoagulation System measures the PT using fibrin clot formation and detection. The ProTime cuvette is a self

6 Operating Precautions • For in vitro Diagnostic Use. • The ProTime instrument is designed for use only with ProTime cuvettes. • The ProTime instru

7 Reagent Preparation and Storage • Bring the foil-pouched cuvette to room temperature prior to use. • ProTime cuvettes are ready-to-use. No additio

8 Rechargeable Battery Facts • Batteries discharge naturally over time (approximately 5% per month). • Battery capacity (the amount of charge the ba

9 SPECIMEN COLLECTION Fingerstick whole blood is the recommended specimen. The Tenderlett Plus device is to be used with the ProTime cuvette, and the