Declaration Of Conformity - DeVilbiss Healthcare SmartLink DV5M Manuel D'utilisation

specs / DeclArATIon
Operating Conditions:
Temperature Range: ......................................................................41°F to 104°F (5°C to 40°C)
Humidity Range: ....................................................................... 0 to 95% R.H. non-condensing
Atmospheric Conditions: ............................................................. Sea level to 9,000' (2,743 M)
Transportation and Storage Conditions:
Temperature Range: ..............................................................-40°F to 158°F (-40°C to +70°C)
Humidity Range: ....................................................................... 0 to 95% R.H. non-condensing

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:
Notified Body:
MDD:
Safety Standards Applied: IEC 60601-1:1988 + A1 1995
EMC Compliance To:
European Contact:
0044
Sunrise Medical dba DeVilbiss Healthcare
100 DeVilbiss Drive, Somerset, PA 15501
CPAP Accessory
DV5M SmartLink Module
For DeVilbiss IntelliPAP or SleepCube CPAP
IIa, Rule 2
ISO 13485:2003
TUV NORD
Annex II Applied
IEC 60601-1-4:2000
ISO 14971:2000
IEC 60601-1-2:2001
Sunrise Medical Ltd.
High Street
Wollaston West Midlands DY8 4PS
England
44-138-444-6688
EN
15
A-DV5M-1