Overview; Intended Use Statement (M1310A) - Philips 50 T Series Instructions For Use Manual

2

Overview

Intended Use Statement (M1310A)

In connection with a fetal monitor, the Series 50 T (M1310A) Fetal
Telemetry System allows continuous non-invasive or invasive wireless
monitoring of an ambulant patient during both antepartum testing and
labor and delivery in that the monitoring of the fetal heart rate (FHR) via
ultrasound or direct electrocardiogram (DECG), and the uterine activity
via an external Toco transducer or an internal intrauterine pressure (IUP)
transducer is possible.
The device is intended to be used in labor-rooms and delivery-rooms and
in antepartum-testing areas. It is not intended to be used for transport
monitoring and home use.
The FHR and uterine activity signals are transmitted continuously via
radio frequency from the telemetry transmitter to the telemetry receiver,
where they are displayed and recorded on the connected fetal monitor.
The Telemetry System should only be used by, or under the direct
supervision of, a licensed physician or other health care practitioner who
is trained in the use of fetal heart rate monitors and in the interpretation
of fetal heart rate traces. US federal law restricts this device to sale by, or
on the order of, a physician.
Chapter 2 - Overview 9