Helio PM5500 Manuel D’Utilisation
dECLARATION OF CONFORMITY
Manufacturer:
Precision Medical, Inc.
300 Held Drive, Northampton, PA 18067, USA
CONTACT: Quality Manager
Phone: 610-262-6090
Authorized European Representative: Emergo Europe (European Office)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
Product:
Gas Mixers for Medical Use (Blender)
Model(s):
PM5470EN, PM5480EN, PM5570EN, PM5580EN
MDD Class:
IIb
Classification criteria:
Clause 3.2 Rule 11 of Annex IX of MDD
As delivered, the object of the declaration described above is in conformity with the
requirements of MDD 93/42/EEC Annex II.3 and the following documents:
Document
Edition
EN 980
2008
EN 1041
2008
ISO 11198
1995
ISO 14971
2007 2nd Ed
ISO 15001
2004
ISO 7000
2004
Notified Body:
TÜV Rheinland Products Safety GmbH
EC Certificate No.: HD60019110 0001
www.precisionmedical.com
ISO 13485 Certified
505963 Rev3 (E) 04/05/10 P
rinted
in
USA