Safety Check - Test Instructions; Introduction; General Notes - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety check - Test instructions | 7.1 Introduction

7 Safety check - Test instructions

7.1 Introduction

7.1.1 General notes

NOTE
The safety check may only be carried out by one or more electricians (as
defined in IEC 61140) who have been appropriately trained for the device to
be inspected.
NOTE
The contents and specified tests described in this document are based on the
international standard, IEC 62353. This standard applies to the testing and in-
spections of medical electrical devices or medical electrical systems complying
with IEC 60601-1 (DIN EN 60601-1).
NOTE
In order to evaluate the safety of medical devices, systems or components of
medical devices or systems, the safety check must be carried out at the fol-
lowing times:
before commissioning
upon maintenance
during inspection and servicing
after repair
on the occasion of repeat tests
NOTE
With regard to devices that have not been manufactured in accordance with
IEC 60601-1 (DIN EN 60601-1), these requirements can be applied taking the
mandatory safety standards for the production of these devices into consider-
ation.
NOTE
If several medical electrical devices (ME device) or electrical devices from sev-
eral manufacturers combined into a system are connected to the KaVo dental
unit, the manufacturer data contained in the instructions for use for all
products subject to the safety checks must also be noted.
NOTE
Accessories of ME devices that might impact the safety of the device to be
tested or the measured results must be included in the safety checks.
NOTE
All tests on accessories included in the safety checks must be documented.
NOTE
Furthermore, the manufacturer data contained in the instructions for use
must be adhered to in all products to be tested and inspected.
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).
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