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Potec PRK-8000 - SAFETY INFORMATION; Safety Information for U.S.A.; EU Representative and Compliance

Potec PRK-8000
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- ii -
SAFETY INFORMATION
Accessory equipment connected to the analog and digital interfaces must be certificated
according to the respective IEC standards (e.g. IEC 60950-1 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with
the system standard EN 60601-1:2006, Clause 16. Everybody who connects additional
equipment to the signal input part or signal output part configures a medical system, and is
therefore responsible that the system complies with the requirements of the system standard
IEC 60601-1:2005, Clause 16. If in doubt, consult the technical service department or your
local representative.
For U.S.A
Do not make any changes or modifications to the equipment unless otherwise specified in the
manual.
If such changes or modifications should be made, you could be required to stop operation of
the equipment.
For EU Countries
The following mark, the name & address of the EU Representative shows compliance of the
instrument with Directive 93/42/EEC.
EU Representative:
Medical Device Safety Service GmbH
Schiffgraben 41, D-30175
Hannover, Germany

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