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EC-Producer Declaration

EC-Producer Declaration
(Regarding to art. 4 paragraph. 2 EC-guideline 89/392/EWG)

We hereby declare, that the product listed below duet to its conception and design and in the make, issued by us is, according to the enclosed notes on operation and mounting, designed to be connected to a medical device respectively computer. Its initial operation is prohibited until the medical device or the computer, into which the mentioned part is to be connected, fully complies with the EC-regulation 89/392/EEC changed by 91/368/EEC and 89/336/EEC changed by 93/31/EEC and 73/23/EEC.

Any adoptions or alteration of which may be made to the product, without the prior consent of ENS EXPERT NETWORK SOLUTIONS, will make this declaration valid.

Denomination: Print2USB Box, Type P2U-MED

For manufacturing or order number please see type plate

We certify conformity with applicable EC-regulations of the product stated above.

89/336/EEC changed by 92/31/(EEC), 89/392/EEC changed by 91/368/EEC, 3/23/EEC, EN50081-1, EN50082-1, EN 55014, DIN EN292/1 and EN292-2

For delivered respectively not ready-mounted or not yet operated components of an Electronically printer device with a manufacturer's declaration according to EC machine regulation the customer will be liable for proper mounting and initial operation as well as for drawing up of the declaration of conformity according to EC-regulations. This declaration certifies compliance with the regulations mentioned, however does not include an assurance of specific characteristics.

Weilerswist, 01-02-11

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