Roche Diagnostics
16 Operator’s Manual · Version 3.0
1 Safety Multiplate® analyzer
Safety precautions
Safety precautions
Generic hazard statements
Particular attention must be paid to the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important.
Operator qualification
The intended users of the analyzer are appropriately trained healthcare professionals
operating the analyzer in a laboratory setting.
Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in the Operator’s
Manual.
o Do not carry out operation and maintenance unless you have been trained by
Roche Diagnostics.
o Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer.
o Leave maintenance, installation or service that is not described in the Operator’s
Manual to trained Roche Service representatives.
o Follow standard laboratory practices, especially when working with biohazardous
material.
o Perform regular security and privacy awareness trainings for staff handling
personal data in a compliant way and according to the privacy principles that are
mandatory by customer regulations.
Safe and proper use of the analyzer
Pers onal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,
safety glasses with side shields, fluid resistant lab coat, and approved disposable
gloves.
o Wear a face shield if there is a chance of splash or splatter.
Accuracy/precision of measured
results
An incorrect measuring result may lead to an error in diagnosis, therefore posing
danger to the patient.
o Do not use consumables that have exceeded their expiration date, otherwise
inaccurate data may be obtained.
o For diagnostic purposes always assess the results in conjunction with the patient’s
medical history, clinical examination, and other findings.
Installation o Leave installation tasks that are not described in the Operator’s Manual to trained
Roche Service representatives.
o Follow the installation instructions carefully.
Operating conditions o Operation outside of the specified ranges may lead to incorrect results or
malfunction of the analyzer.
u See Environmental conditions (p. 62).
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