Roche CoaguChek Pro II, Operator'S Manual

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CoaguChek
®
Pro II · Operator’s Manual
– International Normalized Ratio (INR)
– combination of INR/seconds, or
– combination of INR/%Quick
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 calibration 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 POCT1‑A standard. Data management systems
may have the ability to expand the security features of
the meter, such as enabling operator lockouts. Data
management systems may also enable data transfer to
a hospital information system (HIS) or to a laboratory
information system (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
nonreactive 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 substrate, generating an electrochemical
signal. Depending on the time elapsed when this
signal first appears, it is converted via an algorithm
1 Introduction
• 1