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.

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64. System Description
The INRatio®2 PT Monitor
TopView
LCDDisplay
(Setup) Button: puts the monitor in Setup mode
(OK) Button:
turns the monitor ON and OFF, and accepts/
stores display entries
(Memory) Button:
puts the monitor in Memory
mode
(UP) and (DOWN)Buttons:
changes information on the display
and scrolls between results in the
monitor memory
Test Strip Guide: insert test strip here to turn monitor
ON forTesting
Sample Light: apply blood sample here after the test
strip is inserted

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Certain conditions limit the eectiveness of the INRatio®2 PT Monitoring system to work
properly and provide accurate results.Take note of these limitations and precautions.
Care of your INRatio2 PT monitor
• DONOT allow any liquid to spill on the monitor. If this should occur, unplug the
monitor (if it is plugged in) and callTechnical 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acarryingcaseoranothersecurecontainer.
• 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.
5. Precautions and Limitations
Biosite Inc., San Diego,CA 92121
1-877-441-744 www.hemosense.com
The INRatio®2 PT Monitor
TopEndandBottomViews
BatteryDoor
BatteryDoorRelease
DataPort
PowerSupplyJack
The Test Strip
Electrodes
TestArea
SampleWell

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Patient health status
Current patient health status may aect test results and cause inaccurate results
or results that are not what you expect. It’s 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 monitor result.
See the Performing a Test (Section 8) of this Professional User Guide for more
information about unexpected results.
Performing a test
Running a test with an incorrect strip code may cause inaccurate results. Conrm 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ngerstickbloodsample
Use only fresh capillary blood for testing.
Squeezing the ngerstick site excessively (milking) may release interstitial uid into the
blood sample.This may cause inaccurate results.
The ngerstick site must be completely dry. If any alcohol remains on the nger, it may
cause hemolysis.This may cause inaccurate results.
6. Turning the Monitor ON and OFF
Follow these steps to turn the monitor ON or OFF.
NOTE:The INRatio®2 PT Monitor comes with a Power Supply but you must plug it into the
INRatio2 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.

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NOTE:The LowTemperature symbol ( ) or HighTemperature 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.
In both cases the monitor
will automatically perform a
self test where all segments
will appear on the display.
The monitor will prepare for
testing for a few seconds.
The monitor will then
prompt you to insert a test
strip, or to conrm the strip
code if you inserted a test
strip to turn on the monitor.
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.
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.

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7. 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
(Example timeout when being
prompted to apply blood)
The monitor will
automatically perform a self
test where all segments 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.
2. Enter Setup mode
Press the Setup button to enter Setup mode.
The Setup symbol ( ) 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 rst time, the date will be set to 01/01/2004
and the time will be set to 12:00.
If you are using the external power supply, the monitor will stay on indenitely.
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.