General Information; General Use; Responsibility Of The Manufacturer - GE Corometrics 170 Series Operator's Manual

General Information

General Use

Responsibility of the Manufacturer

Responsibility of the User
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Safety: General Information
If the monitor is cold to the touch or below ambient temperature, allow it to stabilize
to room temperature 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.
Periodically, and whenever the integrity of the monitor is in doubt, test all functions.
Refer to the accompanying
detailed instructions on fetal monitoring using the modalities available on a 170
Series Monitor.
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 for 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 170 Series
of monitors. 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 170 Series Monitor is designed to assist the perinatal staff by providing
information regarding the clinical status of the fetus during labor. 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.
170 Series Monitor
2003023-001
"Maternal/Fetal Monitoring Operator's Manual" for
Revision D