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DECLARATION OF CONFORMITY
Manufacturer: Drive Medical Design & Manufacturing
99 Seaview Boulevard
Port Washington, NY 11050
Product Designation :
Type/Model: 18605
We herewith declare that the above-mentioned product complies with the requirements of EC
Directive 93/42/EEC and the following:
Class: IIa, Rule 2
Quality System Standards Applied: IS09001/ISO13485
Notified Body RWTUV
MDD Annex II Applied
Safety Standards Applied: EN60601-1/IEC 601-1:1988 including A1:1991 and A2:1995
CAN/CSA 22.2 No. 601.1-M90
UL 60601-1:2003
ISO 10079-1:1991
EMC (Electromagnetic Compatibility) Compliance to: EN 60601-1-2 (2001) [All applicable stan-
dards available upon request]
EN55011 Class B
For Baery Operation Only: RTCA/DO-160D, Section 21 (Radiated Emissions), Category M. For
Airline Use
warranty
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