GE Corometrics 250cx Series, Руководство оператора

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Revision C 250cx Series Maternal/Fetal Monitor CE-1
2036946-001
CE Marking Information
0086
CE Marking Information
Compliance
A GE brand Corometrics 250cx Series Monitor bears CE mark CE-0086
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 device is manufactured in India; the CE mark is applied under the
authority of Notified Body BSI (0086).
The country of manufacture and appropriate Notified Body can be found
on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility—Medical Electrical Equipment” and
standard EN 60601-1 “General Requirements for Safety.”
Components of the Certified Systems
The IEC electromagnetic compatibility (EN) standards require individual
equipment (components and accessories) to be configured as a system
for evaluation. For systems that include a number of different
equipments that perform a number of functions, one of each type of
equipment shall be included in the evaluation.
The equipment listed below is representative of all possible
combinations. For individual equipment certification, refer to the
appropriate declarations of conformity.
Component Description:
„
250cx Series Maternal/Fetal Monitor
„
Model 146 Fetal Acoustic Stimulator
„
Intrauterine Pressure Transducer
„
TOCO Transducer
„
FECG Cable/Legplate
„
Ultrasound Transducers (x2)
„
Blood Pressure Hose and Cuff
„
MSpO
2
Interconnect Cable and Sensor
„
MECG Cable
„
FECG/MECG Adapter Cable
„
Remote Event Marker
„
RS-232C Interconnect Cables (x3)
„
Central Nurses Station Interconnect Cable
„
Model 2116B Keyboard and Interconnect Cable
„
Model 1563AAO Telemetry Cable
„
Exergen TemporalScanner TM TAT-5000 Assembly 2036641-001