GE Versana Essential Technical Publication page 5

Regulatory Requirements
Conformance Standards
–
Versana Essential
5759238-100 English Rev. 2
The following classifications are in accordance with the IEC/
EN 60601-1:6.8.1:
• According to 93/42/EEC Medical Device Directive, this is
Class IIa Medical Device.
• According to IEC/EN 60601-1,
• Equipment is Class I, Type BF Applied Parts.
• According to CISPR 11,
• Equipment is Group 1, Class A ISM Equipment.
• Continuous Operation.
• According to IEC 60529,
• The footswitch rate IPx8 is suitable for use in surgical
rooms.
• Probe head (immersible portion) and cable are IPX7.
Probe connector is not waterproof.
This product complies with the regulatory requirement of the
following:
• Council Directive 93/42/EEC concerning medical devices:
the CE label affixed to the product testifies compliance to
the Directive.
The location of the CE marking is shown in the Safety
chapter of this manual.
Authorized EU Representative
European registered place of business:
GE Medical Systems SCS
283 rue de la Minière 78530 BUC, France
User Guide
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