Use Instructions

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
19. General Safety Precautions
The Instructions for Use is regarded to be a part of the instrument, and should
always be kept on hand.
The Instructions for Use describes the present state of the device/system,
including software and accessories, with regard to the fundamental requirements
of the MDD 93/42/EEC.
Exact adherence to the instructions issued is a prerequisite for perfect and
intended functioning of ERT instruments.
Deviation from Intended Use
Any non-observance of the procedures (such as preparation for the measurement
and methods, disinfection procedures, use of accessories and replacement parts
etc.) described in the Instructions for Use results in a deviation from intended use.
In case of a deviation from intended use, the operator/user has to supply proof of
meeting all corresponding fundamental requirements.
The operator/user is, however, responsible for performing the conformity
assessment correctly and is also completely liable for defective products - i.e. the
operator/user is liable for his/her modification of the medical product.
ERT only guarantees for the safety, reliability and function of the instrument if
• installation, extension, modifications, and repairs are exclusively carried out by
personnel authorized for these tasks by ERT.
• the room in which the equipment is operated complies with the country-
specific installation standard.
• the unit can be plugged into a socket with protective conductor system.
• the ambient conditions at the place of installation are suitable for the unit.
• the unit is used according to the training and Instructions for Use.
Unpack your medical device. Please check if the unit is damaged. If so, do not use
it and return it for a replacement.
Report of Incidents
If you recognize or experience any serious incident that has occurred in relation
to the device, you should report this to the manufacturer and the competent
authority of your country.
Subject Safety according to EN 60601-1
This medical device safely insulates the subject from the mains power supply as
required in the safety regulations on leakage current according to EN 60601-1,
Type BF. Nevertheless, a subject environment must be defined. That means
the subject has to keep a distance of at least 1.5 m from all open interfaces,
connectors and the notebook to avoid any contact with electrical voltage.
The physician/operator must not touch any voltage-carrying parts and the subject
at the same time.
General Safety Precautions