Notes For Medical Electrical Systems - KaVo ESTETICA E30 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 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 indi-
vidually. 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 mul-
tiple 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.
7 Safety checks - testing instructions | 7.1 Introduction
103 / 134
Instructions for use ESTETICA E30