Warnings And Precautions - CoaguSense Assure PT Care Prothrombin Time User Manual

5. Warnings and Precautions

patients who have recently taken or are currently taking any
type of Heparin anticoagulants. The system should also not be
used to monitor patients on direct oral anticoagulants (DOACs)
including Factor Xa and Direct Thrombin inhibitors.
Test Site and Blood Sample
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• The Assure
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• The Assure
its expiration date.
• The quality of the blood sample can affect PT test results. A blood sample of
poor quality can produce unreliable results. Read the section on "Collecting
a Fingerstick Sample" for more information.
• Blood samples must be applied to the test strip immediately after collection
or the blood begins to clot, causing unreliable results.
• The blood sample transferred to the test strip must be a minimum of 10 µL in
volume. Low sample volume may cause an error message.
Use only fresh fingerstick capillary blood for testing. The blood should only
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come in contact with the Sample Transfer Tubes provided with the Assure
PT Care PT/INR system. Other products may have anti-coagulant agents on
their surfaces and result in unreliable test results.
Squeezing the fingerstick site excessively (milking) releases interstitial
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"tissue layer" fluid that can cause unreliable results.
The fingerstick site should be washed with warm water and soap, and then
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completely dried. The site must be clean of all hand oils/lotions and foreign
matter, which may cause unreliable results.
WARNING: This test system is not recommended for
PT Care PT/INR system is for in vitro diagnostic use only.
PT Care meter will not produce a result if the test strip is past
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