GE CASE V6.7 Operator's Manual page 3

CE Marking Information
Compliance
Revision C
CE Marking Information
The product CASE bears the CE marking 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.
The medical device has been assigned to class IIa as specified in Annex
IX of the Directive 93/42/EEC.
The CE marking only covers accessories listed in the Order Information
chapter.
The product complies with the electromagnetic immunity requirements
of standard IEC 60601-1-2 "Electromagnetic Compatibility - Medical
Electrical Equipment".
The radio interference emitted by this device is within the limits
specified in EN 55011 - class A.
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external
devices operated in the vicinity of the system cart comply with the
relevant EMC requirements. X-ray equipment, MRI devices, radio
systems, cellular telephones, etc. are possible sources of interference as
they may emit higher levels of electromagnetic radiation. Keep the
system cart away from these devices and verify the performance of CASE
before use.
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
Operator's Manual).
The country of manufacture appears on the device label.
CASE
2060290-201
CE-1