GE ApexPro Operator's Manual page 3

CE marking information
Compliance
Exceptions
R&TTE directive
General information
2001989-200E
The ApexPro telemetry system bears CE mark CE-0459 indicating 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 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 "Medical
electrical equipment - Part 1-2: General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests."
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.
The CIC Pro Clinical Information Center and telemetry server are suitable for use in
the specified electromagnetic environment. For more information, refer to the
appropriate service manual.
The ApexPro 420-460 MHz transmitters and receiver system conform to the R&TTE
Directive 1999/5/EC.
For more information, refer to the appropriate service manual.
This manual is an integral part of the product and describes its intended use. It
should always be kept close to the equipment. Observance of the manual is a
prerequisite for proper product performance and correct operation and ensures
patient and operator safety.
The symbol means ATTENTION: Consult accompanying documents.
Information which refers only to certain versions of the product is accompanied
by the model number(s) of the product(s) concerned. The model number is given
on the nameplate of the product.
The warranty does not cover damages resulting from the use of accessories and
consumables from other manufacturers.
GE is responsible for the effects on safety, reliability, and performance of the
product, only if:
ApexPro™ CE-1