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Basic User Manual
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Regulatory Requirements
Conformance Standards
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 B with BF Applied Parts.
•
Docking Station/Cart is Class 1.
• Continuous
Operation.
•
According to CISPR 11,
•
Equipment is Group 1, Class A ISM Equipment.
•
Docking Station/Cart is Group 1, Class A ISM
Equipment.
•
According to IEC 60529,
•
The footswitch rate is IP X8 (MKF 2 1S/1S-MED HID
GP 26).
•
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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