Safety Checks - Testing Instructions; Introduction; General Instructions - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety checks - testing instructions | 7.1 Introduction

7 Safety checks - testing instructions

7.1 Introduction

7.1.1 General instructions

Note
The safety checks may only be carried out by one or more electricians (as
defined in IEC 61140) who have received appropriate training for the device
to be inspected.
Note
The contents and specified tests in this document are based on the interna-
tional standard, IEC 62353 (DIN VDE 0751-1). This standard applies to the
testing and inspections of medical electrical equipment 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 checks must be carried out at the
times specified below:
▶ Prior to startup
▶ during maintenance
▶ during inspections and servicing
▶ following repair
▶ on the occasion of recurrent 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 con-
sideration.
Note
If the unit comprises several electrical devices or electrical devices from sev-
eral manufacturers that are connected to a system in connection with the
KaVo dental unit, the manufacturer data contained in the instructions for use
for all products subject to safety controls must also be observed.
Note
Accessories to ME devices that could have an impact on the safety of the
device to be tested or the measured results must be included in the safety
checks.
Note
All tests concerning the included safety checks of accessories must be docu-
mented.
Note
Furthermore, the manufacturer data contained in the instructions for use
must be adhered to in all products to be tested and inspected.
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