General Information; General Use; Responsibility Of The Manufacturer; Responsibility Of The User - GE Corometrics 250cx Series Operator's Manual

General Information

General Use

Responsibility of the Manufacturer

Responsibility of the User

Revision C
Safety: General Information
If the monitor is cold to the touch or below ambient temperature, allow it to stabilize
before use.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems Information Technologies. Parts and
accessories used shall meet the requirements of EN60601-1-1.
Disposable devices are intended for single use only. They should not be reused.
Test all functions periodically and whenever the integrity of the monitor is in doubt.
Refer to the "Maternal/Fetal Monitoring, Clinical Applications Manual" for
information concerning the limitations of internal and external fetal heart rate
monitoring techniques.
GE Medical Systems Information Technologies is responsible for the effects on
safety, reliability, and performance if:
assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorized by GE Medical Systems Information
Technologies;
the electrical installation of the relevant room complies with the requirements of
appropriate regulations; and
the monitor is used in accordance with the instructions of use.
This device is intended for use by clinical professionals who are expected to know
the medical procedures, practices, and terminology required to monitor obstetrical
patients. This manual documents all possible parameters available in the 250cx
Series monitor. It is the responsibility of each hospital to ensure that the Labor and
Delivery staff is trained in all aspects of the selected model.
The 250cx Series monitor is only one clinical indicator of fetal status during labor.
The monitor is designed to assist the perinatal staff in assessing the status of a
patient. The monitor does not replace observation and evaluation of the mother and
fetus at regular intervals by a qualified care provider, who will make diagnoses and
decide on treatments or interventions. Visual assessment of the monitor display and
strip chart must be combined with knowledge of patient history and risk factors to
properly care for the mother and fetus.
250cx Series Maternal/Fetal Monitor
2036946-001
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