GE 2000 Series, Руководство оператора

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Revision B Series 2000 Treadmill CE-1
409110-006
CE Marking Information
CE Marking Information
Compliance
The Series 2000 Treadmill bears CE mark CE-0459 indicating its
conformity with the provisions of the Council Directive 93/42/EEC
concerning medical devices and fulfills the essential requirements of
Annex I of this directive. The product is in radio-interference protection
class A in accordance with EN 55011.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
The safety and effectiveness of this device has been verified against
previously distributed devices. Although all standards applicable to
presently marketed devices may not be appropriate for prior devices (i.e.
electromagnetic compatibility standards), this device will not impair the
safe and effective use of those previously distributed devices. See user’s
information.
Exceptions
The Series 2000 Treadmill EMC: Immunity Performance
Users should be aware of known RF sources, such as radio or TV
stations and hand-held or mobile two-way radios, and consider them
when installing a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system may degrade the EMI performance. Consult
with qualified personnel regarding changes to the system
configuration.