GE Dash 3000 Operator's Manual page 14

Patient monitor
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CE Marking Information
General Information
CE-2
wideband transmission systems and HIgh PErformance Radio Local Area
Network (HIPERLAN) equipment".
Article 3.2 Protection of the Radio Spectrum: the product complies with: ETSI EN
300 328 (2003): "Radio Equipment and Systems (RES); Wideband transmission
systems; Technical characteristics and test conditions for data transmission equipment
operating in the 2.4 GHz ISM band and using spread spectrum modulation
techniques.
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:
assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations; and,
the device is used in accordance with the instructions for use.
All publications conform with the product specifications and applicable EN
publications on safety and essential performance of electromedical equipment as
well as with applicable UL and CSA requirements and AHA recommendations
valid at the time of printing.
The quality management system complies with the international standards ISO
9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/EEC.
Dash™ 3000/4000/5000
2000966-386D

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