IfU TECOTHERM NEO TN300 EN - 01.doc
Page 76 of 76
Ref No. TN300 EN-01
15.
Conformity declaration
Manufacturer:
TEC COM GmbH
Address:
Böllberger Weg 170
D-06128 Halle, Germany
The manufacturer, certified according ISO 13485
herewith declares that the actual device Hypothermia System
TECOTHERM NEO
fully
complies to the requirements of
Medical Device Directive
93/42/EEC
Safety, general
EN 60601-1: 2007
Electromagnetic Compatibility
EN 60601-1-2: 2007
Usability
EN 60601-1-6: 06.2008
Alarm systems
EN 60601-1-8: 09.2008
Physiologically closed loop systems PCLS
EN 60601-1-10:2008
Safety of mattresses etc
EN 60601-2-35: 2009:10 E/F
The general requirements of Medical Device Directive 93/42/ EEC are fulfilled acc.
ann. III EC type examination
ann. I
ann. V Declaration of Conformity
Each device is produced in full compliance with the technical documentation.
Place, date
Halle, April 2010
Signature
Manufacturer
TEC COM GmbH
Gesellschaft für Technik,
Technologie und Vermarktung
Böllberger Weg 170
D - 06128 Halle / Saale
Tel.:
0345 / 120 52 04
Fax:
0345 / 120 52 11
E Mail [email protected]
16. Disposal
This device must not disposed of as common industrial waste or household
waste. It must be delivered to a local regular collecting point, to a waste
disposal company or returned to the distributor or the manufacturer.
Inspiration Healthcare Ltd.
Gildor House
West Street
Earl Shilton
Leicester
Leicestershire LE9 7EJ
UK
Tel:
+ 44(0)1455 840555
Fax:
+ 44(0)1455 841464
E Mail: [email protected]
