Valleylab CUSA EXcel-8 - EMC Compatibility; Statutory and Regulatory Requirements; Voluntary Standards

Standards and IEC Classifications
Voluntary Standards
The CUSA EXcel system meets the following standards:
* UL 60601-1
+ cUL/CSA Test requirements: (CSA 22.2, No. 601.1)
+ {EC 601-1 Medical electrical equipment: General requirements for safety
e 1EC60601-1-2 Second edition
e CISPR11 Class A electromagnetic compatibility for industrial-process
measurement and control equipment: Emissions requirements
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© {STA Pre-Shipment Test Procedures, Project 2A.
Statutory and Regulatory Requirements
Class I Medical Device (Special Controls)
EMC Compatibility
Notice
The CUSA EXcel should not be used adjacent to or stacked with equipment other
than specified in the CUSA EXcel User Guide and Service Manual. If adjacent or
stacked use is necessary, the CUSA EXcelEXcelEXcel should be observed to
verify normal operation in the configuration in which it will be used.
The electrical surgical generator used with the CUSA EXcel intentionally applies
RF energy for diagnosis or treatment during activation. Observe other electronic
medical equipment in the vicinity during the CUSA EXcel activation for any
possible adverse electromagnetic effects. Ensure adequate separation of
electronic medical equipment based on observed reactions.
The use of accessories, other than specified in the CUSA EXcel User Guide and
Service Manual, may result in increased emissions or decreased immunity of the
CUSA EXcel.
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CUSA
EXcel-8
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Service
Manual
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