User guide P9-0200-B
7 of 56
Version 2.0.3/2012
Medema Production A/S
Declaration of conformity
Medema Production A/S hereby declares that:
Machine: MC
Concept
Use:
(Prescribed use in
User
Manual)
Model No:
1103
Complies with the Medical Device Directive 93/42/EEC
The product is made in accordance with the harmonized
standard EN 12184 - Electrically powered wheelchairs, scooters
and their chargers.
The product is risk analysed in accordance with the harmonized
standard DS/EN ISO 14971:2007-04-10 2. edition - Medical
devices - Application of risk management to medical devices.
The Mini Crosser can, for a fee, be taken to the nearest
dealer for disposal in accordance with current environmental
regulations.
Manufacturer: Medema
Production
A/S
Address:
Enggårdvej 7, DK-7400 Herning
Tel./Fax
+45 7010 2054 +45 9716 8582
Date: 12.04.2010
Signature: _____________________
Summary of Contents for MC concept 1103
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