Notes For Medical Electrical Systems; Components Of The Safety Check - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety check - Test instructions | 7.1 Introduction
NOTE
The following tests and measurements must be documented, for example in
the medical device book. We recommend using the templates at the end of
the document.
NOTE
The tests must be performed in the order specified by the manufacturer!

7.1.2 Notes for medical electrical systems

NOTE
An ME System is the combination of individual devices (as defined by the
manufacturer) that must meet the following conditions:
at least one of the devices must be a medical electrical device.
The devices must be functionally connected or at least they should be connec-
ted by the application of a multiple socket outlet.
NOTE
With ME systems, the person responsible for putting the system together
must define the necessary measuring parameters and measuring procedures
as required in IEC 60601-1 (DIN EN 60601-1).
NOTE
Each individual device in an ME system, which has a separate connection to
the power supply network or which can be connected to or separated from
the power supply network without the aid of a tool, must be checked individu-
ally. Moreover, the ME system must be checked as one unit to avoid any
"aging" of individual devices leading to unacceptable values in sum.
NOTE
An ME system that is connected to the supply network by means of a multiple
socket outlet must be treated as one device during checks and testing.
NOTE
If the ME system or part of the system is connected to the supply network by
means of an insulating transformer, the transformer must be included in the
measurements.
NOTE
In ME systems, in which more than one ME device are interconnected via data
lines or otherwise, e.g. via electrically conductive attachments or coolant
tubes, the earth wire resistance of every single device must be checked.
NOTE
If it is impossible to check single ME devices that are functionally connected to
an ME system individually for technical reasons, the ME system must be
checked as a whole.

7.1.3 Components of the safety check

Visual inspection (inspection by examination)
Optical appraisal of the safe and usable condition of the medical device and its
accessories.
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