Regulatory Requirements; Conformance Standards - GE LOGIQ V2 User Manual

Regulatory Requirements

Conformance Standards

LOGIQ V2/LOGIQ V1
Direction 5610736-100 Rev. 9
The following classifications are in accordance with the IEC/
EN 60601-1:
• 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.
• Continuous Operation
• According to CISPR 11,
• Equipment is Group 1, Class A ISM Equipment.
• According to IEC 60529,
• The footswitch rate is IPX8.
• 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 Information Technologies GmbH
(GEMS IT GmbH)
Munzinger Strasse 5, D-79111 Freiburg, Germany
Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233
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