Revision C MAC 1200/1200 ST CE-1
2012250-021
CE Marking Information
CE Marking Information
Compliance
The MAC 1200/1200 ST bears CE mark “CE-0459”, notified body GMED,
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.
Any other directive(s) and all the standards the product complies to are
listed in the general information of the operator manual for the product
following this page.
The country of manufacture can be found on the equipment labeling.
The product is in radio-interference protection class A in accordance with
EN 55011.
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 MAC 1200/1200 ST 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.
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