ECOtwin LCD / LED
Section 2
Introduction
General
This chapter provides a general description of the ECOTWIN monitor including:
Intended use
Product Features
Model Configurations
Intended Use
ECOTWIN monitor, non-invasive fetal monitoring system provides graphic and numeric information on
fetal heart rate (FHR) and maternal uterine activity (UA) to help assess fetal well-being before and during
labor. FHR often exhibits decelerations and accelerations in response to uterine contractions or fetal
movements; certain patterns are indicative of hypoxia. Examination of these patterns, the baseline levels,
and variability characteristics can indicate the need to alter the course of labor with drugs or perform an
operative delivery.
It is intended to be used to pregnant woman only by trained and qualified personnel such as medical
professionals especially physicians and nurse of obstetrics in medical institution having antepartum
examination rooms, labor and delivery rooms.
Product Features
The monitored data can be recorded continuously or intermittently on a strip chart recorder at the
operator's discretion. The recorded information includes graphic trend data and text information of
monitor hardware and software configuration, date and time, patient identification, changes to
operational settings, clinician and patient event marks.
Contraindication
The contraindication includes any special symptoms or circumstance that renders the use of a
remedy or the carrying out of a procedure inadvisable, usually because of a risk.
Use the device in accordance with its intended use and instruction with warnings and cautions.
User manual
8