Declaration Of Conformity - DeVilbiss SmartLink-System Bedienungsanleitung

DeclArAtion of conformity

DeClaRaTIoN of CoNfoRMITY
Manufacturer: Sunrise Medical dba DeVilbiss Healthcare
Address: 100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
Product Designation: CPAP Accessory
Type, Model: DeVilbiss
Model DV5M
We herewith declare that the above-mentioned product complies with the requirements of EC Directive 93/42/EEC and the following:
Quality System Standards Applied:
Notified Body:
MDD:
Safety Standards Applied:
EMC Compliance to:
Authorized Representative:
0044
®Registered U.S. Patent and Trademark Office and other countries.
Microsoft Windows XP™, Windows Vista
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Adobe Reader are registered trademarks of Abobe Systems.
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Nonin nVISION are registered trademarks of Nonin.
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DeVilbiss , SmartLink™, IntelliPAP™, and SleepCube™ are registered trademarks of DeVilbiss Healthcare.
®
SmartLink™ Module
®
IS09001/ISO13485: 2003
TÜV NORD
Annex II Applied
IEC 60601-1: 1988 + AI 1995,
IEC 60601-1-4: 2000,
ISO 14971: 2000,
EN ISO 17510: 2000
IEC 60601-1-2: 2001
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
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EN
A-DV5SS 25