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4. Safety Guidelines
Please make sure to read this manual thoroughly and comply with the
instructions provided before installing and operating the instrument. To
ensure the best experience while using Coag 2D, keep this manual for
future reference.
4.1. Conditions of Intended Use
The Coag 2D was designed solely for in vitro diagnostic use. The primary
test specimen is plasma separated with centrifugation from
sodium-citrate anticoagulated human whole blood. Any other usage of
the instrument constitutes as misuse, which may cause damage to the
instrument and may negatively influence test results. False test results
and/or damage to the instrument can be averted by the exclusive use of
manufacturer approved consumables (such as reagents, cleansers and
cuvettes). For the list of manufacturer approved consumables, visit the
official Diagon website (www.diagon.com).
Compliance with this manual is also part of the conditions of intended use
– make sure to follow these instructions regarding cleaning and mainte-
nance procedures to prevent any issues that may arise while operating
the Coag 2D.
The Coag 2D coagulometer is an In Vitro Diagnostic instrument
suitable for healthcare professional use according to the Directive
98/79/EEC.
4.2 General Usage Information
The unboxing, installation and set-up of the Coag 2D may only be done
by your local representative.
The user may not open the exterior of the instrument and may not come
into physical contact with or touch its internals or circuits.
In case of any malfunctions or any unusual odors, fume coming from the
instrument, hit the main switch and disconnect the power cord immedia-
tely. After taking these measures, contact your local maintenance team to
resolve the underlying issue.