Standards and IEC Classifications
Technical Specifications
CUSA EXcel Ultrasonic Surgical Aspirator System Service Manual 5-7
Voluntary Standards
The CUSA EXcel system meets the following standards:
•
UL 60601-1
• cUL/CSA Test requirements: (CSA 22.2, No. 601.1)
•
IEC 601-1 Medical electrical equipment: General requirements for safety
•
IEC 60601-1-2 Second edition
•
CISPR11 Class A electromagnetic compatibility for industrial-process
measurement and control equipment: Emissions requirements
•
ISTA Pre-Shipment Test Procedures, Project 2A.
Statutory and Regulatory Requirements
Class II 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 EXcel 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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