GE Dash 3000 Operator's Manual page 13

CE Marking Information
Compliance
Exceptions
Radio and Telecommunication Terminal Equipment
Directive
2000966-386D
The patient monitor 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 system meets the requirements of EN 60601-1-2 (2001) Medical Electrical
Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard:
Electromagnetic compatibility — Requirements and tests.
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.
The monitor contains a transmitter. The transmitter bears a CE mark indicating
conformity with the essential requirements specified in Article 3 of the Council
Directive 1999/5/EC of 9 March 1999 concerning Radio Equipment and
Telecommunications Terminal Equipment (R&TTE).
The essential requirements are as follows:
Article 3.1 (a) Health Safety; the product complies with the particular medical device
safety standards specified in the Medical Device Directive 93/42/EEC: EN 60601-1/
1990 + A1: 1993 + A2: 1995: Medical electrical equipment. General requirements for
safety.
Article 3.1 (b) EMC; the product complies with:
EN 60601-1-2 (2001) Medical electrical equipment: Part 1: General requirements
for safety - 2. Collateral standard: Electromagnetic compatibility - requirements
and test.
ETS 300 826 (1997): "Electromagnetic compatibility and Radio spectrum
Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for 2.4 GHz
Dash™ 3000/4000/5000 CE-1