Philips Avalon FM20, Instructions For Use Manual

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1 Introduction
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Introducing the Avalon Family of Fetal Monitors
The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40 and FM50. While the
FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very
similar for all monitors. The Avalon fetal monitors also share the same transducers, accessories,
software, and are compatible with the Avalon CTS Cordless Fetal Transducer System (M2720A).
Intended Use
The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Fetal/
Maternal Monitors are intended for:
•
non-invasive monitoring of fetal heart rates and movements.
• non-invasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternal
noninvasive blood pressure, and maternal oxygen saturation.
• invasive monitoring of fetal Direct ECG and intrauterine pressure and for displaying and
recording of fetal and maternal ECG waves. (FM30 and FM50 only)
• displaying, storing and recording patient data and parameter values and for generating alarms from
fetal and maternal parameters.
• transmitting patient data and parameter values to a patient information and surveillance system.
• use by trained health care professionals.
• use in antepartum testing areas, in labor and delivery rooms and during postpartum recovery in the
hospital environment. They are not intended for use in intensive care units or operating rooms.
• transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as
doctors’ offices, and for use in private households. (FM20 and FM30 only)
WARNING
The fetal/maternal monitors are not intended for:
•
use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).
• ECG measurements on patients connected to electrical stimulators or with cardiac pacemakers.
• use of the invasive measurements IUP and fetal DECG and use of the patient module (M2738A)
in domestic establishments and those connected directly to the public low-voltage supply network
that supplies buildings used for domestic purposes.
CAUTION
US federal law restricts this device to sale by, or on the order of, a physician.