Inverness Medical Inratio2 User manual

Professional User Guide
INRatio®2 ProthrombinTime (PT) Monitoring System
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®

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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.

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(Example MM/DD/YY format)
3. Select the desired format for displaying the date
Choose between MM/DD/YY or DD/MM/YY formats.The rst 2
sets of digits (DD/MM or MM/DD) will be ashing 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.
4. Set the year
The last 2 digits of the year will begin to ash on the display. Use
the and buttons to change the year. Press the button
when you have the correct year on the display.
5. Change the month
The month will be ashing 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 ashing on the display. Use the and buttons
to change the day.
Press the button when you have the correct day on the
display.
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 ashing 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)

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INR Mode
Test results are displayed in
International Normalized Ratio
(INR) units only.The INR is a
mathematical correction of the
ProthrombinTime (PT) result
that adjusts for dierences in
the reagents that are used in
calculating your test results.
INR + PT Mode
Test results are displayed in
International Normalized Ratio
(INR) units and Prothrombin
Time (PT) seconds.
(Example INR + PT Mode)
INR + PT Mode
8. Change the hour
The hour will be ashing on
the display. Use the and
buttons to change the hour.
Press the button when
you have the correct hour on
the display.
9. Change the minutes
The minutes will be ashing
on the display. Use the
and buttons to change the
minutes.
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 dierent unit display
modes.This unit display mode controls how much information
will appear along with your INR test result on the monitor display.
INR Mode (Example INR Mode)
NOTE:The test result in INR units will appear on all of the 4 display modes.

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Press the button when you have the correct display mode on the display.
11. Select the target range mode
An INR target range may be set in your monitor to alert you when 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 theTarget ON and
OFF modes.
If you want the target range mode ON, press the button
when the Target Range ON symbol ( ) is on the display. Go to
step 12. ( = Target range mode ON)
If you want the target range mode OFF, press the button
when theTarget 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)
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
Test results are displayed in
International Normalized Ratio
(INR) units, ProthrombinTime
(PT) seconds and the Quality
Control (QC) results that are
taken every time you perform
a test.
INR + QC Mode (Example INR + QC Mode)
INR + PT +QC Mode (Example INR + PT + QC Mode)

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12. Set the lower limit of the target range
The lower limit of the target range will be ashing, and the
LowTarget 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.
Press the button when you have the correct lower limit on
the display.
13. Set the higher limit of the target range
The higher limit of the target range will be ashing, and the
HighTarget symbol ( ) will appear on the display. The“HI”
message will also appear on your test result display whenever
your result falls above the higher limit. Use the and buttons
to change the higher limit.
Press the button when you have the correct higher limit on
the display.
After setting the higher limit,“OK?”will begin ashing on the
display. If the target range is correct, press the button to
store the target range in the monitor.You will return to the
monitor display that prompts you to insert a test strip.
Or, if you would like to re-enter a target range, press the and
buttons to go back to the lower limit and repeat steps 12 and 13
until the correct target range is on the monitor display.

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(Example test result below
target range — INR mode)
Example monitor displays when test results fall outside the target range
The LowTarget symbol ( )
will appear with your test result
on the display whenever your
result falls below the lower limit
of your target range.
The HighTarget symbol ( )
will appear with your test result
on the display whenever your
result is above the upper limit of
your target range.
NOTES:
• Ifyouneedtogobackandcorrectanyselectionsbeforeyouexit,youwillneedtorepeat
all Setup steps. Press the Setup button to return to the monitor display where you are
prompted to insert a test strip. Press the Setup button again to re-enter Setup mode
where you will begin by setting the date.
• AfteryoucompleteallSetupsteps,youwillreturntothemonitordisplaywhereyourst
entered Setup mode.
• Yourdate,time,displaymode,andtargetrangesettingsarestoredinthemonitorusing
battery power. If you are using a Power Supply and have removed the batteries (or the
batteries have completely run down), you will lose your settings within about two hours
if you unplug the Power Supply.To save your settings, install or replace the batteries as
needed even when using a Power Supply.
(Example test result below
target range — INR + QC mode)
(Example test result above
target range — INR + PT mode)
(Example test result above target
range — INR + PT + QC mode)

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2. Insert a test strip into the test strip guide on the
monitor
Remove a fresh test strip from its foil pouch. Insert it into the
test strip guide so that the clear end with the vertical contact
bars goes in rst. On the blue end of the strip you should be able
to read the word“INRatio®”appearing from left to right. Make
sure the sample well in the strip lines up with the green light on
the test strip guide.
3. Match the code on the monitor display with the
strip code on the test strip pouch or strip container
If the codes match, simply press the button while“OK?“is
ashing on the display and proceed to Step 4.
8. Performing a Test
Follow these steps to perform a test.
CAUTION:Alwaysplacethemonitoronaatsurfacethatisfreeof
vibrationwhileyouperformatest.DONOTholdthemonitorinyourhand.
Failure to do so may cause inaccurate results.
1. Press and hold the button or insert a fresh test strip to turn the
monitor ON
The monitor will
automatically perform a self
test where all segments on
the display will appear.
The monitor will prepare for
a test for a few seconds.
If you turned the monitor on
by pressing the button,
the monitor will prompt you
to insert a test strip (go to
step 2).
If you turned the monitor on
by inserting a fresh test strip,
the monitor will prompt you
to conrm the strip’s code
(go to step 3).

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If the codes do not match, use the and buttons to change the
rst digit of the code which will then be ashing.
Press the button to accept the rst digit and move to the next
digit. Change each digit using the and buttons, then press the
button to accept each digit and move to the next digit.
To scroll more quickly through letters and numbers while
making changes, hold the and buttons down.
After setting the fth digit,“OK?”will begin ashing on the
display. If the code is correct, press the button to store the
code in the monitor.
Or, if you need to correct the code, press the and buttons to
go back to the rst digit and repeat step 3 until the correct code is
on the monitor display.
CAUTION:Alwaysmatchthecodeonthemonitordisplaywiththestrip
code on the test strip pouch/container. Failure to do so may cause
inaccurate results.
NOTE: If you entered an invalid strip code, the CAUTION symbol
() will ash underneath the code. Re-enter the correct code
beginning with the rst digit, which is now ashing.
4.Waitforthemonitortowarmup
The monitor will count down for a few seconds and display the
Temperature symbol ( )as it warms up for the test.

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The monitor display will prompt you to apply a blood sample
when it’s ready to perform a test.
5.Getangersticksample
See Instructions for Collecting a Fingerstick Sample (Section 9) for getting the correct blood
sample to perform a test.
6.Applythebloodsampletothesamplewellonthe
test strip
Make sure you apply the sample directly over the green light.
DONOT move the monitor or your nger as you apply the
sample.
If you applied a blood sample before the monitor was ready, the
CAUTION symbol ( ) will ash on the display. Remove the test
strip. DONOT add more blood to the test strip. Go back to step 2
and re-test with a fresh test strip.
7.Waitforthemonitortobeepandthencountdown
for a few seconds as it performs the test
If the monitor does not beep and count down, it means not
enough blood was applied. DONOT add more blood to the test
strip. Remove the test strip. Then go back to step 2 and re-test
with a fresh test strip.

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The test result will appear on the monitor display along with the
date and time.
Test results are automatically stored in the monitor memory along
with the date and time of the test. See Reviewing Past Results in
the Monitor Memory (Section 10) for reviewing past results.
(Example INR mode result)
CAUTION:Unexpectedresults:
Anunexpectedresultmayincludeanyresultthatfallsoutsidethe
therapeutictargetrange,oraresultthatfallsinsidethetargetrange,but
isnotconsistentwiththepatient’scurrenthealthstatus(e.g.,theyhave
symptoms such as bleeding or bruising).
Whatcausesunexpectedresults:
1.A hematocrit (percentage of blood that is red blood cells) that is higher or lower than
the validated operating range of the INRatio®2 system can cause an inaccurate result. Refer
 totheteststrippackageinsertformoreinformation.Vericationofthepatient’shematocrit
will help ensure the reliability of results obtained with the PT monitor.
2.Lupus or antiphospholipid antibody syndrome (APS) may falsely prolong the INR value.
Testing with an APS-insensitive laboratory method is recommended.
3.Certain prescription drugs (e.g., heparin–Refer to the test strip package insert for more
information) and over-the-counter medications (e.g., antibiotics) can aect the action of
oral anticoagulants and the INR value.
4.Liver diseases, congestive heart failure, thyroid dysfunction, and other diseases or
conditions can aect the action of oral anticoagulants and the INR value.
5.Changes in diet, lifestyle, or taking nutritional supplements such as ginkgo biloba can
aect the action of oral anticoagulants and the INR value.
Be aware of any of these conditions before you begin testing your patients, and ask them to
alert you if there has been any change in their health status or medications once they begin
testing.
Whattodowhenyougetanunexpectedresult:
Always follow your usual procedures for re-testing on the PT monitor, re-testing using an
alternative method, adjusting the dose of anticoagulant medication, or any other corrective
actions.

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8. Turn the monitor OFF when you are nished testing
To turn the monitor o, press and hold the button for about two seconds. Remove the
used test strip when prompted, and discard it in a Sharps or other puncture proof container.
If using batteries, the monitor will turn o automatically if you leave it unattended for a few
minutes. If using the power supply, the monitor will stay on indenitely. It is recommended
that you turn the monitor OFF manually to conserve power.
BeforeturningthemonitorOFF,youalsohavetheoptionto:
1.Perform another test
Remove and discard the used test strip, then begin again at step 2 with a fresh test strip,
using a dierent nger for the ngerstick sample.
2.Review past results in the monitor memory
Press the Memory button to enter Memory mode (see Reviewing Past Results in
Monitor Memory in Section 10 for reviewing past results).
3.Change the monitor settings
Press the Setup button to enter Setup mode (see Changing the Monitor Settings in
Section 7 for changing your monitor settings).
9. Collecting a Fingerstick Sample
Follow these steps to obtain a drop of blood from a nger.
CAUTION:Itisimportantthatyouusethecorrecttechniqueanda21
or 23 gauge lancet to obtain the right type and amount of blood sample.
Failure to do so may cause inaccurate results. If you use another type of
lancingdeviceorlancet,makesuretofollowtheinstructionsthatcame
with that device to get the correct blood sample.
1. Prepare sampling supplies
•Lancet
 •Alcoholpad
 •Gauze
 •Sharpsorotherpunctureresistant
container