Inverness Medical Inratio2 User manual

Professional User Guide
INRatio®2 ProthrombinTime (PT) Monitoring System
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Professional User Guide
Welcome
Congratulations on your purchase of the INRatio2®PT Monitoring System.This guide will
provide you with useful information on how to perform PT testing with the INRatio2.
Table of Contents page
Introduction
1. Introduction 4
2. Getting your System ready forTesting 4
3. Contacting Technical Support 5
The INRatio®2 PT Monitor
4. System Description 6
5. Precautions and Limitations 7
6.Turning the Monitor ON and OFF 8
7. Changing the Monitor Settings 10
Performing a Test
8. Performing aTest 16
9. Collecting a Fingerstick Sample 20
10. Reviewing Past Results in the Monitor Memory 22
11. Quality Control 23
Maintenance and Troubleshooting
12. Care and Cleaning of your Monitor 25
13. Installing/Replacing Monitor Batteries 25
14.Troubleshooting Error Messages 26
Helpful Reference Information
15. Hazards, LCD Display Icons, and Symbols 29
16. Performance Characteristics and Specications 32
17.Warranty 32
18. Glossary of Terms 33
19. Index 35

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1. Introduction
Before You Begin
Before using this system to test ProthrombinTime (PT), read this entire User Guide and the
inserts that came with the INRatio®Test Strips and the Lancet device.
Take special note of CAUTIONS throughout this User Guide.You must complete proper
training on the INRatio2 PT Monitoring system before you begin using the system.
Intended Use
The INRatio®2 PT Monitoring system is used for the quantitative measurement of Prothrom-
binTime (PT) in fresh, capillary whole blood.The INRatio2 PT Monitoring 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 INRatio2 PT Monitoring 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 dierences 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 dierences in reagents.The INRatio2 PT
Monitoring system provides both a PT and INR result with every test.
2. Getting your System ready for Testing
Your INRatio®2 PT Monitoring system comes with:
• INRatio2PTMonitor
• ProfessionalUserGuide
• CD-ROMofUserGuidesinotherlanguages
• QuickReferenceGuide
• Lancets
• PowerSupply
• TrainingVideo
• CapillaryTubes
• CarryingCase

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NOTES:
• DONOTuseanyotherPowerSupplywiththeINRatio2PTMonitororyou
may damage the system.
• TheINRatio2PTmonitorcanalsobepoweredusingstandardAAalkaline
batteries.
3. Contacting Technical Support
Contact Technical Support if you have questions about using your system
correctly or if you are having problems with the monitor or strips.
Technical Support
[phone] (toll free) or [phone]
To re-order supplies, contact the distributor who provided you with the INRatio®2 system kit.
Product
INRatioTest Strips
(Box of 12)
INRatio2 Test Strips
(Box of 48)
INRatio2 PT Monitor Power Supply
USA
INRatio2 PT Monitor Power Supply
withWorldwide Plugset
MicroSafe CapillaryTubes
Unistik 21g Single Use Lancets
(Box of 50)
Part Number
0100071
0100139
0100011
0100260
0200235
0902009
Description
12 single-use test strips for use
with the INRatio2 PT Monitor
48 single-use test strips for use
with the INRatio2 PT Monitor
USA Power Supply for use with the
INRatio2 PT Monitor
Worldwide Power supply for use
with the INRatio2 PT Monitor
Bag of 50 disposable capillary
sampling tubes
Disposable single use lancets
You will also need:
• INRatioTestStrips
(INRatioTest Strips are compatible with
the INRatio2 PT Monitor)
• Alcoholpads
• Gauzepads
• Punctureresistant(Sharps)container
Additional INRatioTest Strips and Lancets may be ordered through an authorized INRatio2
distributor.