INRatio 2 PTINR Professional Testing System User Guide Rev A July 2010

Professional User Guide

Welcome Congratulations on receiving your Alere™ INRatio®2 PT/INR Professional Testing System. This guide will provide you with useful information on how to perform PT/INR testing with INRatio®2.

Table of Contents

page

Introduction 1. Introduction... 5 2. Getting your System Ready for Testing... 6 The INRatio®2 PT/INR Monitor 3. System Description... 8 4. Precautions and Limitations... 10 5. Turning the Monitor ON and OFF... 12 6. Changing the Monitor Settings...15 Performing a Test 7. Performing a Test...24 8. Printing Results...31 9. Collecting a Fingerstick Sample...35 10. Reviewing Past Results in the Monitor Memory...38 11. Quality Control...41 Maintenance and Troubleshooting 12. Care and Cleaning of your Monitor...43 13. Installing/Replacing Monitor Batteries...43 14. Troubleshooting Error Messages...45 15. Contact Alere...50 Helpful Reference Information 16. Hazards, Monitor Display Icons, and Symbols...51 17. Performance Characteristics and Specifications...55 18. Warranty...55 19. Glossary of Terms...57 20. Index...59

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1. Introduction Before You Begin Before using this system to test your Prothrombin Time (PT), read this entire User Guide and the inserts that came with the INRatio® PT/INR Test Strips and the Lancing Device. Take special note of CAUTIONS throughout this User Guide. You must complete proper training on the AlereTM INRatio®2 PT/INR Professional Testing System before you begin using the system. Intended Use The AlereTM INRatio®2 PT/INR Professional Testing System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The AlereTM INRatio®2 PT/INR Professional Testing System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The AlereTM INRatio®2 PT/INR Professional Testing System is not intended to be used for screening purposes. Test Principle A drop of blood is applied to the test strip, where it is drawn into the test area. The blood mixes with reagents that start the clotting reaction. As the blood clots, there is a change in the impedance in the sample. The monitor detects the change and then calculates the PT for the sample and reports the result on the screen. The reagents used in performing PT tests can vary substantially between testing methods. This may cause differences in test results depending on the method used. For this reason, the International Normalized Ratio (INR) unit was developed. The INR is a mathematical correction of the PT result that adjusts for sensitivity differences in reagents. The AlereTM INRatio®2 PT/INR Professional Testing System provides both a PT and INR result with every test.

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2. Getting your System Ready for Testing Your AlereTM INRatio®2 PT/INR Professional Testing System comes with: • INRatio®2 PT/INR Monitor

• Power Supply Kit

• User Guide

• Training Video (DVD)

• User Guide with E-Trainer (CD)

• Capillary Tubes

• Quick Reference Guides

• Carrying Case

• Disposable Lancets NOTES: • DO NOT use any other Power Supply with the AlereTM INRatio®2 PT/INR Monitor or you may damage the system. • The AlereTM INRatio®2 PT/INR Monitor can also be powered using standard AA alkaline batteries. You will also need: • AlereTM INRatio® PT/INR Test Strips (AlereTM INRatio® Test Strips are compatible with the AlereTM INRatio®2 PT/INR Monitor) • Alcohol wipes • Gauze pads • Puncture proof container (Sharps) Additional AlereTM INRatio® PT/INR Test Strips and Lancets may be ordered through an authorized AlereTM INRatio®2 PT/INR System distributor.

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Ordering Information: To order Alere™ INRatio® PT/INR Test Strips, Lancets or Capillary Tubes contact the distributor who provided you with your Alere™ INRatio®2 PT/INR Professional Testing Kit. Refer to the Contact Alere section of this User Guide for additional contact information. Product AlereTM INRatio® PT/INR Test Strips (Box of 12)

Part Number 0100071

Description 12 single-use test strips for use with the AlereTM INRatio®2 PT/INR Monitor

AlereTM INRatio® PT/INR Test Strips (Box of 48)

0100139

48 single-use test strips for use with the AlereTM INRatio®2 PT/INR Monitor

AlereTM INRatio®2 Power Supply Kit (USA)

0100011

USA Power supply for use with the AlereTM INRatio®2 PT/INR Monitor

AlereTM INRatio®2 Power Supply Kit (Outside the USA)

0100260

Worldwide Power supply for use with the AlereTM INRatio®2 PT/INR Monitor

MicroSafe® Capillary Tubes

0200235

Bag of 50 disposable capillary sampling tubes

Unistik®2 21g Single Use Lancets (Box of 50)

0902009

50 Disposable single use lancets

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3. System Description The AlereTM INRatio®2 PT/INR Monitor Top View

Monitor Display Symbols, instructions and results will be displayed on this screen Sample Light Apply blood sample here after the test strip is inserted Test Strip Guide Insert test strip here to turn monitor ON for testing

OK Button Turns the monitor ON and OFF, and accepts/stores display entries (UP) and (DOWN) Buttons Changes information on the display and scrolls between results in the monitor memory (Memory) Button Puts the monitor in Memory mode (Setup) Button Puts the monitor in Setup mode (Print) Button Puts the monitor in Print mode 8

The AlereTM INRatio®2 PT/INR Monitor

The INRatio® PT/INR Test Strip

Bottom and Top End Views Electrodes Area where change in the impedance in the sample is measured as the blood clots. Test Area Area where the blood mixes with reagents that start the clotting reaction. Battery Door Battery Door Release

Sample Well Area where the blood drop is applied and is drawn into the test strip.

Power Supply Jack Data Port

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4. Precautions and Limitations Certain conditions limit the effectiveness of the AlereTM INRatio®2 PT/INR Professional Testing System to work properly and provide accurate results. Take note of these limitations and precautions. Care of your INRatio®2 PT/INR Monitor • DO NOT allow any liquid to spill on the monitor. If this should occur, unplug the monitor (if it is plugged in) and contact Alere Product Support immediately. • The monitor is a delicate instrument, and should be handled with care. Dropping or other mishandling may cause it to malfunction. • The monitor should be transported in its supplied carrying case. • DO NOT store the monitor below -4ºF/-20ºC or above 158ºF/70ºC. Testing environment • Room temperature for testing should be between 50ºF and 95ºF (between 10ºC and 35ºC). • The monitor and test strip must also be at room temperature before use. • Relative humidity should be between 15% and 95%, without condensation. • Atmospheric pressure should be between 700 hPa and 1060 hPa. Patient health status Current patient health status may affect test results and cause inaccurate results or results that are not what you expect. It is important to take certain health factors into consideration when interpreting test results and deciding on a course of action for your patients. Failure to do so may lead to an incorrect interpretation of the PT/INR monitor result. See the Performing a Test (Section 7) of this Professional User Guide for more information about unexpected results. 10

Performing a test Running a test with an incorrect strip code may cause inaccurate results. Confirm the strip code each time a test strip is inserted. Test with the monitor on a level surface that is free of vibrations. Testing on an uneven surface or shaking may cause inaccurate results. DO NOT hold the monitor in your hand while running a test. Blood sample must be applied to the test strip immediately after collection or the blood will begin clotting. This may cause inaccurate results. Test strips are for single use only. DO NOT reuse them or re-apply blood to them. This may cause inaccurate results or a testing error. DO NOT move or touch the monitor while it is running a test. Collecting a fingerstick blood sample Use only fresh capillary blood for testing. Squeezing the fingerstick site excessively (milking) may release interstitial fluid into the blood sample. This may cause inaccurate results. The fingerstick site must be completely dry. If any alcohol remains on the finger, it may cause hemolysis. This may cause inaccurate results.

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5. Turning the Monitor ON and OFF Follow these steps to turn the monitor ON or OFF. NOTE: The INRatio®2 PT/INR Monitor comes with a Power Supply but you must plug it into the monitor and a wall jack before the monitor will turn ON. Turning the monitor ON You have 2 options for turning the monitor ON: 1.

Press and hold the

button until the monitor turns on.

2.

Insert a fresh test strip if you are ready to perform a test.

In both cases the monitor will automatically perform a self test where all symbols will appear on the display.

The monitor will prepare for testing for a few seconds.

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The monitor will then prompt you to insert a test strip, or to confirm the strip code if you inserted a test strip to turn on the monitor.

NOTE: The Low Temperature symbol ( ) or High Temperature symbol ( ) will appear on the display if the ambient temperature is outside the operating range of the monitor. If you get a “LO” or “HI” message, move the monitor to a location that is within the operating range and begin again. You will not be able to perform a test until the ambient temperature is within the monitor’s operating range. With the monitor ON you can: • perform a test, or • enter Setup mode where you can change the monitor settings, or • enter Memory mode where you can review past results. See the appropriate sections of this User Guide for complete information for all of these options.

NOTE: If your monitor is connected to a computer or other external device, 2 dashes “- -” will appear on the display. This means the monitor is turned OFF but is communicating with the external device.

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Turning the monitor OFF You can turn the monitor OFF whenever it is idle (not in the process of performing a test) by pressing and holding the button for about two seconds. If you are using the external power supply, the monitor will stay on indefinitely.

NOTE: Turning the monitor OFF manually when it is not being used will help conserve battery power. If you are using battery power, and the monitor is left idle for about 10 minutes, the monitor will count down for about 10 seconds and then turn OFF. Press any button to keep the monitor turned ON and return to the previous monitor display. (Example timeout when being prompted to apply blood)

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6. Changing the Monitor Settings Follow these steps to change the date, time, units (how you want your test results displayed), and whether you want to set a target range for your results. 1. Press and hold the

button to turn the monitor ON

The monitor will automatically perform a self test where all symbols will appear on the display.

The monitor will begin preparing for a test for a few seconds.

The monitor will then prompt you to insert a test strip.

NOTE: You may access Setup mode whenever your monitor is turned on, or after performing a test. 15

2. Enter Setup mode Press the Setup button The Setup symbol (

to enter Setup mode.

) will appear on the display along with the year that’s currently set in the monitor.

NOTE: When you turn on the monitor for the first time, the date will be set to 01/01/2004 and the time will be set to 12:00. 3. Select the desired format for displaying the date Choose between MM/DD/YY or DD/MM/YY formats. The first 2 sets of digits (DD/MM or MM/DD) will be flashing on the display. Use the and buttons to switch between date formats. Press the button when you have the correct date format on the display.

(Example MM/DD/YY format)

4. Set the year

The last 2 digits of the year will begin to flash on the display. Use the and buttons to change the year. Press the button when you have the correct year on the display.

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5. Change the month

The month will be flashing on the display. Use the and buttons to change the month. Press the button when you have the correct month on the display.

6. Change the day

The day will be flashing on the display. Use the

Press the

and

buttons to change the day.

button when you have the correct day on the display.

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7. Select the desired format for displaying the time of day

Choose between 12-hour (AM/PM) or 24-hour formats. The 2 digits next to “hr” will be flashing on the display. Use the and buttons to switch between 12-hour and 24-hour time formats. Press the button when you have the correct time format on the display. (Example 12-hour format)

8. Change the hour

The hour will be flashing on the display. Use the and button when you have the correct hour on the display.

buttons to change the hour. Press the

9. Change the minutes

The minutes will be flashing on the display. Use the

and

buttons to change the minutes.

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Press the

button when you have the correct minutes on the display.

10. Select the test result display mode

Use the and buttons to choose 1 of 4 different display modes. This display mode controls how much information will appear along with your INR test result on the monitor display.

NOTE: The test result in INR units will appear on all of the 4 display modes.

INR Mode

INR Mode

(Example INR Mode result)

Test results are displayed in International Normalized Ratio (INR) units only. The INR is a mathematical correction of the Prothrombin Time (PT) result that adjusts for differences in the reagents that are used in calculating your test results.

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INR + PT Mode Test results are displayed in International Normalized Ratio (INR) units and Prothrombin Time (PT) seconds. INR + PT Mode

(Example INR+PT result)

INR + QC Mode

INR + QC Mode

(Example INR + QC Mode)

Test results are displayed in International Normalized Ratio (INR) units, along with the Quality Control (QC) results that are taken every time you perform a test.

INR + PT + QC Mode

INR + PT + QC Mode Press the

(Example INR + PT + QC Mode)

Test results are displayed in International Normalized Ratio (INR) units, Prothrombin Time (PT) seconds and the Quality Control (QC) results that are taken every time you perform a test.

button when you have the correct result display mode showing.

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11. Select the target range mode An INR target range may be set in your monitor to alert you when your test results fall outside the range. CAUTION: If results fall outside the target range, or if results fall within the target range but are not consistent with the patient's current health status (e.g., they have symptoms such as bleeding or bruising), follow your usual procedures for taking corrective action. Use the the

and

buttons to switch between the Target ON and OFF modes.

If you want the target range mode ON, press the ( ) is on the display. Go to step 12. ( = Target range mode ON)

button when the Target Range ON symbol

If you want the target range mode OFF, press the button when the Target Range OFF symbol ( ) is on the display. You will return to the monitor display that prompts you to insert a test strip. Skip steps 12 and 13. ( = Target Range mode OFF)

12. Set the lower limit of the target range

The lower limit of the target range will be flashing, and the Low Target symbol ( )will appear on the display. The “LO” message will also appear on your test result display whenever your result falls below the lower limit. Use the and buttons to change the lower limit.

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