Declaration Of Conformity; Dc Adapter; Ac Adapter - DeVilbiss Healthcare iGo 306DS Manual Del Usuario

declArAtion of conformity

Altitude ....................................................................................................................................................................... 0 –13,123 feet (0 – 4,000 meters)
Nominal Sound Level .......................................................................................................................................40 dBA at 3 in PulseDose Delivery Mode
Maximum Sound Level (from front) @ 3 LPM continuous flow ........................................................................................................................ 47.8 dBA
Pressure Relief Mechanism ............................................................................................................................................. 20 psi ±20% (138 kPa ± 20%)
OSD Set Points ..................................................................................................................................................................≥ 84% - Normal Light (green)
Electrical Power:
DeVilbiss Rechargeable Battery (Lithium Ion) ....................................................................................................................................... 8.8 Amp Hrs
AC Adapter Input Voltage Range ....................................................................................................................................................90-264 50/60 Hz
DC Adapter ......................................................................................................................................................... 12 Volt Negative Ground Vehicles
Adapter Manufacturer Info:
AC Adapter .......................................................................................... Jerome Industries Model # WSX828M, Autec Model # DT-EM250-2805
DC Adapter ......................................................................................................................................................................... EDAC, Model ED1010E
Audible Alerts:
• Power Fail
• Low Battery
• Low Oxygen Output
• High Flow/Low Flow
• No Breath Detected in PulseDose Mode
• High Temperature
• Unit Malfunction
Device Classification ................................................................................................................................................ Class I, Type BF Applied Part, IPX1
CAUTION– When moving the iGo from an extreme environment, allow time for your iGo to acclimate to the recommend operating
environment. Operating your iGo outside the recommended operating environment may impact performance, cause
damage, and will void the warranty.
Specifications subject to change without notice.
DeClaRaTIon of ConfoRMITY
Manufacturer:
Address:
Product Designation:
Catalog Number:
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:
0044
Sunrise Medical
dba DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset, PA 15501-2125 USA
Oxygen Concentrator
306DS
IIa, Rule 2
ISO13485:2003
TÜV NORD
Annex II Applied
EN 60601-1:1990+A1+A2
EN ISO 8359:1996
IEC 60601-1-4:2000
ISO 14971:2000
EN 60601-1-2:2001
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
75-85% - Low O2 Light (yellow)
< 75% - Service Required Light (red) and Audible Alert
EN
A-306 15