GE MAC 5000, Operator'S Manual

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MAC 5000 System — 2000657-024, Revision A CE-1
Marking Information
Compliance
This device bears CE mark CE-0366 or 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.
For devices manufactured in the United States, the CE
mark is applied under the authority of Notified Body
GMED (0459).
For devices manufactured in Germany, the CE mark is
applied under the authority of Notified Body VDE
(0366).
The country of manufacture and appropriate Notified
Body 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
There are no exceptions.
0459