Medonic M16C-US, Руководство пользователя

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Section 1: Safety Instructions
Section Overview
Introduction This section describes the safety features and warnings associated with the
Medonic M-Series.
Contents This section contains the following topics:
Topic See Page
Intended Use 5
Safety Instructions 6
Biohazards 6
Emergency Procedures 7
Warning Signs in Manual 7
Signs on Equipment 9
1.1 Intended Use
Description The Medonic M-Series is a fully automatic hematology analyzer intended for
in vitro diagnostic testing of human blood samples under laboratory
conditions.
Operator
Requirements Operator must have basic laboratory skills and be aware of good laboratory
practice.
Warranty
limitations

Service must be performed by Boule Medical AB (hereafter referred to as
Boule), CDS or by service personnel authorized by Boule.

Use only original spare parts and Boule authorized reagents, controls,
calibrators and cleaners. (If these products are substituted it may void your
warranty)

Operators and laboratory supervisors are responsible that Boule products are
operated and maintained according to the procedures described in manuals,
control inserts and technical bulletins.
Warranty
limitations in
depth

Each Boule system is tested using recommended reagents, controls,
calibrators and cleaners. All performance claims are generated as part of this
complete system.

Boule products do NOT make diagnoses on patients. Boule intends its
diagnostic products (systems, software and hardware) to be used to collect
data reflecting the patient’s hematological status. This data, in conjunction
with other diagnostic information and the evaluation of the patient’s
condition, can be used by a trained clinician to establish a patient’s diagnosis
and to define clinical treatment.