CE MARKING INFORMATION
i •
0459
Compliance
This monitor bears the CE Mark indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical
devices.
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
120 Series Maternal/Fetal Monitor
Model 146 Fetal Acoustic Stimulator
Intrauterine Pressure 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)
COROLAN Interconnect Cable
Central Nurses Station Interconnect Cable
Model 2116B Interconnect Cable
Exceptions
None
Monitor System EMC:
Immunity
Performance
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.
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