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2010-8401CE-E
February 2018
Page 8 of 8
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CONFORMITY WITH EN 60601-1
CONFORMITY WITH EN 60601-1 (§ 6.8.2 b):
The manufacturer, assembler, installer or distributor 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.
•
Electrical installation of the corresponding premises complies with local electrical codes. (e.g. IEC/NEC)
•
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 manufacturer is not responsible in the event of an accident or non-performance.
This device complies with the requirements of the FDA Quality System Regulation and 93/42/EEC European directive
but its operation may be affected by other devices being used nearby, such as diathermy and high frequency
electrosurgical equipment, mobile telephones, CB and other portable devices, microwave ovens, induction plates or
even remote control toys or any other electromagnetic interferences which exceed the levels specified by the EN
60601-1-2 standard.
EU Representative
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
Tel: +49-511-39-08 95 30
Fax: +49-511-39-08 95 39
www.mdi-europa.com
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
Tel: 205-856-7200 Fax: 205-856-0533
