Declaration Of Conformity - DeVilbiss Healthcare SleepCube Standard CPAP DV51 Serie Guía De Instrucciones

EN
Degree of protection from electric shock .........................................................................................................................................Type BF Applied Part
Degree of protection against ingress of liquids ............................................................................................................................................................IPX1
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Mode of operation ............................................................................................................................................................................................ Continuous
clinical Specifications for Digital Outputs
Pressure ........................................................................................................................................................................................ 0 to 25.5 cmH2O ± 0.5

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:
EMc compliance To:
Authorized Representative:
®Registered U.S. Patent and Trademark Office and other countries.
0044
SE-DV51
16
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP
DeVilbiss® IntelliPAP™ or SleepCube™DV5x Series CPAP
Models DV51 Standard CPAP
IIa, Rule 2
ISO13485:2003
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
DEclaration of conformity