14. CE Notice
Marking by the symbol
indicates compliance of the
Vitalograph Model 4000 COPD-6 to the Medical Devices Directive of
the European Community.
The Vitalograph Model 4000 COPD-6 is intended for use in a
variety of professional healthcare environments, e.g. primary care,
hospital wards and occupational health centres, except for near
active high frequency surgical equipment and the RF shielded
room of an ME system for magnetic resonance imaging, where the
intensity of electromagnetic disturbance is high. The customer or
the user of the COPD-6 should assure that it is not used in such an
environment.
The Model 4000 COPD-6 has been tested in accordance with:
EN60601-1:2006 + A1:2013
Medical electrical equipment. General requirements for basic safety
and essential performance
EN 60601-1-11: 2015
Medical electrical equipment. General requirements for basic safety
and essential performance. Collateral Standard: Requirements for
medical electrical equipment and medical electrical systems used
in the home healthcare environment.
EN 60601-1-2: 2015
Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
Summary of Contents for copd-6 4000
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