1-2 120 Series Maternal/Fetal Monitor Revision B
2015590-001
Safety: General Information
General Information
General Use
If the monitor is cold to the touch or below ambient temperature, allow it to reach
ambient, 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 “Chapter 6, Functional Checkout Procedure”.
Refer to the “Maternal/Fetal Monitoring Operator’s Manual” for information
concerning the limitations of internal and external fetal heart rate monitoring
techniques.
Responsibility of the Manufacturer
GE 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;
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.
Responsibility of the User
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 120 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 120 Series Monitor is designed to assist the perinatal staff by providing
information regarding the clinical status of the mother and 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.
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