Notes For Medical Electrical Systems - KaVo Primus 1058 Life TM Instructions For Use Manual

Note
KaVo offers a medical device book for keeping an inventory and recording es-
sential master data on the medical device. The medical device book is only
available in German (Mat. no. 0.789.0480).
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 manu-
facturers) that must meet the following conditions:
▶ At least one of these devices must be a medical electrical device.
▶ The devices must be functionally connected or at least they should be
connected by the application of a multiple socket outlet.
Note
With ME systems, the person responsible for putting the system together
must employ the necessary measuring parameters and measuring proced-
ures defined 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 mains, or which can be connected to or separated from the
power supply mains without the aid of a tool, must be checked individually.
Moreover, the ME system must be checked as one unit to avoid the situation,
in which the „aging" of individual devices lead to unacceptable values in sum.
Note
An ME system that is connected to the power supply mains by means of a
multiple socket outlet must be treated as one device during checks and test-
ing.
Note
If the ME system or part of the system is connected to the power supply
mains by means of an isolating transformer, the transformer must be in-
cluded 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.
7 Safety check - Test instructions | 7.1 Introduction
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Instructions for use Primus 1058 Life