I m p o r t a n t I n f o r m a t i o n
20
DECLARATION OF CONFORMITY
Manufacturer:
Sunrise Medical
Address:
Respiratory Products Division
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
Product Designation:
Oxygen Conserving Device
Type, Model:
DeVilbiss® PulseDose® Compact Conserving
Device Model PD1000U, PD1000R, PD1000G
We herewith declare that the above-mentioned product complies with the
requirements of EC Directive 93/42/EEC and the following:
Quality System Standards Applied:
IS09001/EN46001
Notified Body RWTÜV
Safety Standards Applied:
CAN/CSA C22.2 No. 0-M91
CAN/CSA C22.2 No. 601.1-M90
CAN/CSA C22.2 No. 601.1S1-94
IEC 601-1:1988
IEC 60601-1:1988 Amendment 1 & 2
IEC 68-2
European Contact:
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
0044
®Registered U.S. Patent and Trademark Office and other countries.
D e c l a r a t i o n o f C o n f o r m i t y
21
PHYSICIAN INFORMATION
Name: __________________________________________________________
Address: ________________________________________________________
_______________________________________________________________
Telephone: ______________________________________________________
Emergency Telephone: _____________________________________________
PRESCRIPTION INFORMATION
Patient’s Name: __________________________________________________
Flow Setting (LPM): _______________________________________________
SET-UP INFORMATION
Name of Person Setting Up: ________________________________________
OXYGEN PROVIDER
Emergency Telephone Number: ______________________________________
This instruction guide was reviewed with me and I have been instructed on
the safe use and care of the DeVilbiss PulseDose oxygen conserving device.
_______________________________________________________________
Patient or Caregiver Signature
Date
