GE LOGIQ 7, Basic User Manual

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LOGIQ 7 Basic User Manual i
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Direction 2392206-100 Rev. 1
Regulatory Requirements
Conformance Standards
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 B
with BF or CF Applied Parts.
• According to CISPR 11, this is Group 1, Class A ISM
Equipment.
• According to IEC 60529, the footswitch rate IPx8 is suitable
for use in surgical rooms.
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 Chapter 2 of this
manual.
European registered place of business:
GE Medical Systems Europe
Quality Assurance and safety Regulatory Manager
BP 34
F 78533 Buc Cedex, France
Tel: +33 (0) 1 30 70 4040