User Manual

Introduction • 1
13
INR is a standardized measurement of the rate at which
blood clots. A low INR can indicate an increased risk of
blood clots, while an elevated INR can indicate increased
risk of bleeding.
The meter guides you through the test, step by step,
using icons and instructions on the display. Each box of
test strips has its own code chip that you insert into the
meter. This code chip contains lot-specific information
about its test strips, such as the expiration date and cali-
bration data. Optional liquid controls for the system are
also available.
The CoaguChek Pro II meter has the ability to connect to
a data management system (DMS) through the Handheld
Base Unit from Roche Diagnostics (available separately)
or via wireless communication (WLAN). The CoaguChek
Pro II meter supports data exchange via the POCT1A
standard. Data management systems may have the ability
to expand the security features of the meter, such as ena-
bling operator lockouts. Data management systems may
also enable data transfer from a HIS and/or to a LIS. Refer
to the manuals of the Handheld Base Unit and of your
DMS for technical details.
Test principle The CoaguChek Tests contain desiccated reagents.
These consist of activators, a peptide substrate, and non-
reactive components. When a sample is applied to a test
strip, the reagent dissolves and the activators start the
coagulation process, leading to the formation of the
enzyme thrombin. Simultaneously the meter starts to
measure the time. Thrombin cleaves the peptide sub-
strate, generating an electrochemical signal. Depending
on the time elapsed when this signal first appears, it is
converted via an algorithm into customary coagulation
units (depending on the test, into INR, %Quick, or
seconds) and the result is displayed.