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Visionaire™ 2 and visionaire™ 3 en – AirSep MN157-1 B User Manual

Page 153

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VisionAire™ 2 and VisionAire™ 3

EN

AirSep

®

Corporation

EN-27

MN157-1 rev. B

8.0

Conformity with EN 60-601 (

§

§ 6.8.2 b) / Classification:


The manufacturer, assembler, installer or importer are not considered to be
responsible themselves for the consequences on the safety, reliability and
characteristics of a device unless:

- The assembly, fitting, extensions, adjustments, modifications or repairs have

been performed by persons authorized by the party in question,


- The electrical installation of the corresponding premises complies with IEC

regulations.


- The device is used in accordance with the instructions for use. “If the

replacement parts used for the periodic servicing by an approved technician do
not comply with the manufacturer’s specifications, the latter is absolved from all
responsibility in the event of an accident. Do not open the device while in
operation: risk of electrical shock. This device complies with the requirements
of the MDD(93/42/EEC:2007/47/EC) Annex I European directive but its
operation may be affected by other devices being used close by, such as
diathermy and high frequency electro-surgical equipment, defibrillators, short
wave therapy equipment, mobile telephones, CB and other portable devices,
microwave ovens, induction plates or even remote control toys and more
generally electromagnetic interferences which exceed the levels specified by
the EN 60601-1-2 standard.