Itc ProTime Microcoagulation System User Manual

ProTime® Microcoagulation System For in vitro Diagnostic Use Operator’s Manual for Patient Self-Testers TABLE OF CONTENTS INTENDED USE ...

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

11 • 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

12 6. Start the Test • Press the button to start the test. This signals ProTime to draw the sample into the cuvette. • It takes only a few seconds

13 • The instrument then progresses to the test and displays the TESTING screen. 8. Read the Result In a few minutes, the result is ready. • Pre

14 TROUBLESHOOTING Most often, a fault message indicates a problem with blood collection or a mistake in the test procedure. If an error message appe

15 Screen Display Source of Error Method of Control SAMPLE NOT SEEN TURN OFF TRY AGAIN Can be caused by small samples, clots, air bubbles, or a sea

16 MAIN MENU OPTIONS The options presented in the MAIN MENU are: Each of these options will lead to sub menus within the selection. The following bu

17 SHOW RESULTS Press the button to move the highlight bar to the SHOW RESULTS line in the MAIN MENU. Press the button to view the SHOW RESULTS me

18 Example: Printing Data Press the button to set the feature to ON or OFF and then press the button to save the setting. • Highlight the SHOW R

19 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

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

20 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

21 SET BEEP If SET BEEP is selected, the following screen appears: To turn BEEP SOUND ON press the button. The SET BEEP ON screen appears: Then pr

22 PERFORMANCE CHARACTERISTICS The ProTime instrument has been tested extensively by doctors, nurses and patients. Eighty-four people, ages 7 to 81,

23 Clinical Performance Comparison A. ProTime3 vs. ProTime Linear regression containing clinical fingerstick results from three sites yielded a reg

24 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

25 APPENDIX I – RUN LQC When RUN LQC is selected from the MAIN MENU, the following screen is displayed and the user can select NOR/ABN (NORMAL/ABNORMA

26 LQC RECORDS The LQC record will be displayed as follows, depending upon the OID ON/OFF selections and the LQC NOR/ABN selections. For LQC Normal

27 APPENDIX II – USE OF PID AND OID NUMBERS The PID/OID selection is indicated only by the location of the highlight (text on the screen is unchanged)

28 After the cuvette is inserted, the user has the option to set an operator ID (OID) and/or a patient ID (PID) if the OID and/or PID have been enable

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

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

30 Password The password option permits the professional to access portions of the ProTime program that are not accessible to patient self-testers.

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

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

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

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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

5 SAFETY FEATURES AND QUALITY CONTROL Each ProTime and ProTime3 cuvette has two channels for performing the two levels of control which work simultane

6 If the calculated INR is: Then ProTime displays: < 0.6 INR LOW 0.6 - 0.79 INR < 0.8 0.8 - 7.0 Result 7.1 - 9.9 Result - followed by "

7 SERVICE AND MAINTENANCE Routine Maintenance and Cleaning DO NOT immerse the ProTime instrument or allow fluid to enter the cuvette housing. Inspe

8 Battery Replacement Refer to the instructions provided with the replacement battery. The used battery should be disposed of in accordance with local

9 Charging the Battery The battery of the instrument needs to be charged before the first use. 1. Connect the AC/DC power module to an electrical serv