Declaration Of Conformity - DeVilbiss DV5HH User Manual

DeClArATIon of ConformITy

THIS IS THE EXCLUSIVE REMEDY AND LIABILITY FOR CONSEQUENTIAL AND
INCIDENTAL DAMAGES UNDER ANY AND ALL WARRANTIES ARE EXCLUDED TO
THE EXTENT EXCLUSION IS PERMITTED BY LAW. SOME STATES DO NOT ALLOW
LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, OR THE LIMITATION
OR EXCLUSION OF CONSEQUENTIAL OR INCIDENTAL DAMAGES, SO THE ABOVE
LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.
This warranty gives you specific legal rights, and you may also have other rights which vary
from state to state.
DECLARATION OF CONFORMITY
Manufacturer:
Address:
Product Designation:
Type, Model:
We herewith declare that the above-mentioned product complies with the requirements of
EC Directive 93/42/EEC and the following:
Class:
Quality System Standards Applied: ISO13485:2003
Notified Body:
MDD:
Safety Standards Applied:
EMC Compliance To:
Authorized Representative:
®Registered U.S. Patent and Trademark Office and other countries.
0044
Sunrise Medical dba DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP
DeVilbiss® IntelliPAP™ or SleepCube™DV5x Series
CPAP Models DV51 Standard CPAP and DV53 & DV54
AutoAdjust and DeVilbiss Heated Humidifier Model
DV5HH
IIa, Rule 2
TÜV NORD
Annex II Applied
IEC 60601-1:1988 + A1 1995
IEC 60601-1-4:2000
ISO 14971:2000
EN ISO17510:2002.
IEC 60601-1-2:2001
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS ENGLAND
44-138-444-6688
EN
A-DV5HH
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