Product Manual

CE Marking Information
2040604-012D SEER
®
Light CE-1
CE Marking Information
Compliance
NOTE
This CE mark information is part of the operator manual and is
applicable for all products marketed and distributed by GE Medical
Systems Information Technologies in the European community.
These SEER
®
Light devices bear the CE mark 0459, notified body GMED,
indicating its conformity with the provisions of the Council Directive 93/
42/EEC, concerning medical device 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”.
NOTE
Refer to the SEER Light service manual for additional compliance
and exception information.
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. 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.