CoaguSense Coag-Sense User manual
Coag-Sense®
Prothrombin Time (PT)/INR
Monitoring System
Quick Reference Guide
Getting Started and Setting Up the Meter
1.
Gather test supplies such as test strips, lancets and sample transfer tubes.
2. Warm your hands to increase circulation.
3. Wash your hands with warm soapy water and completely dry them.
4. Placethemeteronaat,non-vibratingsurface.
5. Turn the meter on by pressing the POWER button on the top left side of the meter.
Performing a ProThrombin Time Test
Activity Display Screen/Visual Aid
1. After turning on the meter, you will know it is ready
when the display reads: “READY INSERT STRIP”.
Open a test strip pouch, tearing at the notched end.
Removethestripandsetthepackageaside.
2. Holding the round end, gently push the strip com-
pletely into the meter. The meter will display “PAT
STRIP DETECTED” and begin the strip warming
process changing the display to: “WARMING
PLEASE WAIT”. The time for completion of the
warming process will be displayed in seconds.
3. The meter will beep to let you know it is ready for a
sample and display the message “APPLY SAMPLE”.
Thesampleapplicationareawillashgreenindicating
wherethesampleshouldbeapplied.Youhave2.5
minutes to apply the sample to the strip.
PST
Intended Use-TheCoag-SenseSelf-TestProthrombinTime(PT)/INRMonitoringSystemisanin vitro diagnostic
devicethatprovidesquantitativeprothrombintime(PT)results,expressedinsecondsandINRunits.Itusesfresh
capillarywholeblood.Itisintendedforusebyproperlyselectedandsuitablytrainedpatientsortheircaregiversonthe
orderofthetreatingphysician.Patientsshouldbestabilizedonwarfarin-type(coumarin)anticoagulationtherapyprior
toself-testing.Thedeviceisnotintendedtobeusedforscreeningpurposes.
For In Vitro Diagnostic Use
Activity Display Screen/Visual Aid
4. Removethecapfromtheone-time-use21glancet,
place it against the skin, and push down rmly against
thengertolancethesurfaceofskin.Note:smaller
gauge lancets should not be used.
5. The blood should bleed freely. If it doesn’t, gently
squeezethengeroneachsideofthewoundto
get it started. Lower your hand below your heart if
necessary to produce a “bead” sized drop of blood.
6.
Hold sample transfer tube below bulb. DO NOT
TOUCHORSQUEEZEBULB.Withtubehorizontal
touchtiptobeadofblood.Letcapillaryactionllcap-
illaryportionoftubeuntilbloodowstops.Squeeze
ngertogenerateadditionalbloodifrequiredtocom-
pletelyllcapillaryportionofsampletransfertube.
7. Movengerstoatsidesofbulbbeingsuretocover
air hole. Rest hand on meter. Insert tip into sample
application well of test strip, touching tip down on
stripatashinggreenlight.Gentlysqueezebulbuntil
bloodleavestube(donotproduceairbubbles).Keep
pressureonbulbandpullawayfromteststrip(avoids
back suction). You must apply blood to the test
strip within 15 seconds of lancing the nger.
Themeterwillknowthatyouhaveaddedthesample
and the display will then read: “TESTING, PLEASE
WAIT”. Testing time is patient’s actual clotting time.
8. When testing is complete, the meter beeps once
and the results (INR and Prothrombin Time (PT) in
seconds) appear on the screen.
Recordtheresults.Removetheteststripandproperly
dispose along with the transfer tube and lancet. Turn
othemeter.
NOTE: ReadSelf-TestUser’sManualforcompleteinstructionsforuse,indications,warnings,precautionsand
troubleshooting tips. If any error messages are displayed, refer to the “Troubleshooting” section of the User
ManualorcallCoaguSenseTechnicalServiceat1-866-903-0890.
CSIP/N100287Rev.AE
For In Vitro Diagnostic Use
EMERGO EUROPE
Prinsessegracht20
2514 AP, The Hague
The Netherlands
©CoaguSenseInc.
48377FremontBlvd.,STE113
Fremont,CA94538USA
(510)270-5442(510)226-6540(Fax)
www.coagusense.com
Product Made in U.S.A
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