Features - EDAN F15 Series User Manual

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
Chapter1 Safety Guidance
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 In order to ensure the operator and patient's safety, read through this chapter before using
this monitor.
2 This user manual is written to cover the maximum configuration. Therefore, your model
may not have some of the parameters and functions described, depending on what you
have ordered.
3 Whenever a monitor's identifier appears on the title, paragraph or picture, it means that the
information applies to that monitor only. Where the information applies to all models, no
distinction is made.
4 The functions frequently used are marked with an asterisk *, for example 4.14 *Reviewing
Alarms.
1.1 Intended Use/Indications for Use
F15 series are intended for real time monitoring of fetal physiological parameters, including
noninvasive monitoring of single, twin or triple fetal heart rates (FHR), fetal movements (FM).
F15 series are also intended for real time monitoring of maternal physiological parameters, including
uterine activity, maternal heart rate (MHR), maternal ECG (MECG), temperature (TEMP), oxygen
saturation (SpO2), pulse rate (PR), and noninvasive blood pressure (NIBP).
F15 series are intended for invasive monitoring of direct ECG (DECG) and intrauterine pressure (IUP).
F15 series can be compatible with FTS-3 which is a wireless system intended for monitoring
physiological parameters including fetal heart rates (FHR), fetal movements (FM), uterine activity.
F15 series are intended for monitoring in a bath (FTS-3 only) or shower (FTS-3, and F15 wireless
transducers).
F15 series can display, store, and print patient information and parameters, provide alarms of fetal and
maternal parameters, and transmit patient data and parameters to Central Monitoring System.
Monitoring FHR using ultrasound is recommended from the 24th week of gestation. FECG is only
indicated for use on women who are at >36 completed weeks, with singleton pregnancies.
F15 series are intended to be used by trained health care professionals in clinical and hospital-type
facilities, in private households and during transports in healthcare facilities.

1.2 Features

F15 series fetal and maternal monitors are divided to wired models and wireless models based on
configurations and functions and there are total two models: Wired model F15 and wireless model F15
Air.
The following table lists the configuration of F15 series.
014_14.1_F15_Series_User_Manual
CAUTION
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Safety Guidance
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