Welch Allyn Schiller AT-2plus Manual page 3

6-channel electrocardiograph

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DECLARATION OF CONFORMITY

Electrocardiograph:

Serial numbers starting with:

Years of manufacturing:

We, the undersigned,hereby declare that the medical device (classe II a) specified above conforms with the Essential Require-

ments listed in Annex I, of EC Directive 93/42/EEC

This declaration is supported by:

Certificate of approval No:

11425-02

ISO 9001 / EN 46001 by SQS valid date 17. January 2001

45112-60-01

ISO 9001/ 07.94, EN 46001 / 08.96 by DEKRA valid date 30.04.2003

and

45112-16-01

Annex II, Section 3 of the Directive 93/42/EEC, valid date 30.01.2003

Baar (Switzerland) 12.03.1998

JJ Schmid

Research & Development Manager

Cardiovit AT - 2 Plus

025.

1996 onwards

iii

Markus Bütler

Quality Assurance Manager

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