CoaguSense Coag-Sense Prothrombin Time PT/INR Self-Test User's Manual page 11

section on "Collecting a Fingerstick Sample" for more
information.

Use only fresh fingerstick capillary blood for testing. The
blood should only come in contact with the products
provided with the Coag-Sense System. Other products
may have anti-coagulant agents on their surfaces and
result in unreliable test results.

The Coag-Sense PT/INR System is for in vitro diagnostic
use only.

Blood samples must be applied to the test strip
immediately after collection or the blood begins to
clot, causing unreliable results.

Squeezing the fingerstick site excessively (milking)
releases "tissue layer" fluid and tissue factors that can
cause unreliable results.

The fingerstick site should be washed with warm water
and soap, and then completely dried. The site must be
clean of all hand oils/lotions and foreign matter, which
may cause unreliable results.

If Alcohol wipes are used, wipe the fingerstick site with a
gauze pad and make sure the site is completely dry. If
any alcohol remains (or is re-introduced) on the finger, it
may cause unreliable results.

The quality of fingerstick and the sample delivered are
important to the test results. If there is a question
about the sample or sample collection, obtain a new
strip, repeat the fingerstick on a different finger, and
test again.

If a test requires a repeat, use a different finger for the
fingerstick, since blood may have started to clot on the
first finger, which may cause unreliable results.
CoaguSense, Inc. For In Vitro Diagnostic Use
Warnings and Precautions
Page 11