GE Medical Systems T-2100, Operator'S Manual, Page: 3 / 28

CE Marking Information
2021403-026B T-2100 Treadmill CE-1
CE Marking Information
Compliance
NOTE
The CE mark information is part of the operator manual and is
applicable for all products marked and delivered by GE Medical
Systems Information Technologies in the European community.
The T-2100 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.
EMC Immunity Performance
WARNING
RF sources — 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.
Refer to the service manual for detailed exceptions and compliance
information.