Medema Mini Crosser M-MaxX User Manual download pdf (Page 6)

User guide P9-0135-B 6 of 52 Version 1.0.3/2012

Medema Production A/S

Declaration of conformity

Medema Production A/S hereby declares that:

Machine: Mini Crosser

Use: (Prescribed use in

User Manual)

Model No: M-MaxX

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: _____________________

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Medema Mini Crosser M-MaxX User Manual Page 6