Vitalograph alpha 6000, Инструкция по эксплуатации

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EN
DT_0006 Issue 15
15. CE Notice
Marking by the symbol indicates compliance of the Vitalograph Model
6000 Alpha to the Medical Devices Directive of the European Community.
The device is intended for and suitable for use in a variety of professional
healthcare environments, e.g. primary care, hospital wards, occupational health
centres and clinics, 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 device should assure that it is used in such an environment.
The device was tested in accordance with:
EN 60601-1:2006 + A1:2013 with US deviations - Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
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.
EN 60601-1-2:2015 - Emissions tests
Emissions test Compliance
Electromagnetic environment -
guidance
RF emissions CISPR 11 Group 1
The device uses RF energy only for
its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class B
The device is suitable for use in all
establishments, including those
connected to the public mains
network (e.g. doctor’s offices in
residential areas)