User Manual Part 2

2001989-301A- draft 1 ApexPro™ CE-1
CE marking information
Compliance
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
“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.
Exceptions
The CIC Pro Clinical Information Center and ApexPro Telemetry Server are suitable
for use in the specified electromagnetic environment. For more information, refer to
the appropriate service manual.
R&TTE directive
The ApexPro 420-460 MHz transmitters and receiver bear the CE mark CE 0123
indicating conformity to R&TTE Directive 1999/5/EC.
The product complies with the requirements of standard EN 300 220-1 [ETSI 300
220-1 v1.2.1]: “Electromagnetic Compatibility and Radio Spectrum Matters (ERM);
Short Range Devices (SRD); Part 1: Technical Characteristics and Test Methods”.
For more information, refer to the appropriate service manual.
General information
 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.
Draft