[11.E] Certificate Of Compliance Medical Devices - h/p/cosmos 150/50 locomotion de med Operating Instructions And Service Manual

Certificate of compliance medical devices
[11.E]
n
Certificate of Compliance
for devices for medical and rehabilitation purposes
Manufacturer
h/p/cosmos sports & medical gmbh
Am Sportplatz 8
DE 83365 Nussdorf-Traunstein / Germany
phone +49 / 86 69 / 86 42 0
fax +49 / 86 69 / 86 42 49
email@h-p-cosmos.com
Product running machine (treadmill ergometer) Classification according to European Council
UMDNS Code: 14-141
Models h/p/cosmos stratos lt med
h/p/cosmos mercury lt med
h/p/cosmos stellar lt med
h/p/cosmos quasar lt med
h/p/cosmos pulsar lt
h/p/cosmos pulsar lt 3p
h/p/cosmos venus
h/p/cosmos gaitway II S
h/p/cosmos 150/50 locomotion DE med
We herewith declare that the above mentioned types meet the following standards:
European Council Directive 93/42 EEC (MDD medical device directive). The appendix I + II of the
Directive 93/42 EEC is being applicable. The n - mark gets affixed to the products.
The following listed and fulfilled Norms are elements of our production:
DIN VDE 0751-1:2001-10, DIN EN 60601-1:1990 + A1:1993 + A2:1995, DIN EN 60601-1-1:2001,
DIN EN 60601-1-2:2001 + A1:2006, DIN EN 60601-1-4:1996 + A1:1999, DIN EN 60601-1-6:2004,
DIN EN 957-1:2005-11, DIN EN 957-6:2001-11, DIN EN ISO 14971:2000,
DIN EN ISO 9001:2000, DIN EN ISO 13485:2003
This certificate of compliance covers all running machine models which are listed above and which are
produced by h/p/cosmos on and from November 24, 2006. The validity of this certificate of compliance expires
on the release date of a certificate of compliance with a later issue date, which may be necessary due to
technical modifications or due to changes of standards, guidelines and directives.
83365 Nussdorf-Traunstein, November 24, 2006
h
Franz Harrer
President
© 2008 h/p/cosmos sports & medical gmbh
www.h-p-cosmos.com
Directive 93/42 EEC: Class II b
Classification according to DIN EN 957-1:2005-11: SA
file: n:\article\cos14310m5-v1.04hpc-en\20080901_cos14310m5-v1.04hpc-en_manual_h-p-cosmos_running_machine.doc
email@h-p-cosmos.com
h/p/cosmos stratos med
h/p/cosmos mercury med
h/p/cosmos stellar med
h/p/cosmos quasar med
h/p/cosmos pulsar
h/p/cosmos pulsar 3p
h/p/cosmos saturn
h/p/cosmos gaitway II F
h/p/cosmos 150/50 locomotion E med
p
Wolfgang Petry
Safety Representative for Medical Devices
created 01.09.2008 printed 08.10.2008
certificates
page: 163 of 176