Declaration Of Conformity - DeVilbiss Healthcare SleepCube AutoAdjust CPAP DV54 Serie Guía De Instrucciones

EN
Sound Level (tested per ISO 17510) ...................................................................................................................................................................... 26 dBA
Filter Specifications
Standard Filter > 3.0 micron particles
Optional Fine Particle Filter > 0.3 micron particles
Max Flow Rates
83 L/m @ 6.5 cmH2O (1/3 max pressure)
134 L/m @ 13 cmH2O (2/3 max pressure)
163 L/m @ 20 cmH2O (max pressure)
Pressure Accuracy ...................................................................................................................................................................................... ± 1.0 cmH2O
Pressure Swings
(cmH2O peak to peak at 500mL tidal volume, sine wave profile)
Breaths per minute
@ 6.5 cmH2O
@ 13 cmH2O
@ 20 cmH2O
Equipment classification with respect to protection from electric shock.............................................................................................................. Class II
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
Mask Pressure .............................................................................................................................................................................0 to 25.5 cmH2O ± 0.5
Patient Flow ...................................................................................................................................................................-127 to +127 L/min ± 10 L/min
Leak Flow ............................................................................................................................................................................ 0 to +127 L/min ± 10 L/min
Estimated Tidal Volume ............................................................................................................................................................................... 0 to 1023 mL
NOTE
–Tidal Volume is an estimate. It is provided for trending purposes only.

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:
SE-DV54
16
10 15 20
0.5 0.5 0.5
1.0 1.0 1.0
1.0 1.0 1.0
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP
DeVilbiss® IntelliPAP™ or
SleepCube™DV5x Series CPAP Model
DV54 AutoAdjust
IIa, Rule 2
ISO13485:2003
TÜV NORD
Annex II Applied
DEclaration of conformity
Safety Standards Applied:
EMC Compliance To:
Authorized Representative: Sunrise Medical Ltd.
®Registered U.S. Patent and Trademark Office and other countries.
0044
IEC 60601-1:1988 + A1 1995
IEC 60601-1-4:2000
ISO 14971:2000
EN ISO17510:2002
IEC 60601-1-2:2001
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688