Full Text Searchable PDF 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. Place the meter on a flat, non-vibrating surface.
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.
Remove the strip and set the package aside.
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
”.
The sample application area will flash green indicating
where the sample should be applied. You have 2.5
minutes to apply the sample to the strip.
PST
Intended Use
- The Coag-Sense Self-Test Prothrombin Time (PT)/INR Monitoring System is an
in vitro
diagnostic
device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh
capillary whole blood. It is intended for use by properly selected and suitably trained patients or their caregivers on the
order of the treating physician. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior
to self-testing. The device is not intended to be used for screening purposes.
For In Vitro Diagnostic Use
Activity
Display Screen/Visual Aid
4.
Remove the cap from the one-time-use 21g lancet,
place it against the skin, and push down firmly against
the finger to lance the surface of skin. Note: smaller
gauge lancets should not be used.
5.
The blood should bleed freely. If it doesn’t, gently
squeeze the finger on each side of the wound to
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
TOUCH OR SQUEEZE BULB. With tube horizontal
touch tip to bead of blood. Let capillary action fill cap-
illary portion of tube until blood flow stops. Squeeze
finger to generate additional blood if required to com-
pletely fill capillary portion of sample transfer tube.
7.
Move fingers to flat sides of bulb being sure to cover
air hole. Rest hand on meter. Insert tip into sample
application well of test strip, touching tip down on
strip at flashing green light. Gently squeeze bulb until
blood leaves tube (do not produce air bubbles). Keep
pressure on bulb and pull away from test strip (avoids
back suction).
You must apply blood to the test
strip within 15 seconds of lancing the finger.
The meter will know that you have added the sample
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.
Record the results. Remove the test strip and properly
dispose along with the transfer tube and lancet. Turn
off the meter.
NOTE:
Read Self-Test User’s Manual for complete instructions for use, indications, warnings, precautions and
troubleshooting tips. If any error messages are displayed, refer to the “Troubleshooting” section of the User
Manual or call CoaguSense Technical Service at
1-866-903-0890
.
CSI P/N 100287 Rev. AE
For In Vitro Diagnostic Use
EMERGO EUROPE
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
© CoaguSense Inc.
48377 Fremont Blvd., STE 113
Fremont, CA 94538 USA
(510) 270-5442 (510) 226-6540 (Fax)
www.coagusense.com
Product Made in U.S.A