Outline

This product is designed to simulate various antenatal and intrapartum, normal and abnormal electronic fetal monitoring (EFM) patterns clinically to enhance EFM pattern recognition skills of users in a safe and repeatable training environment. This aims to accelerate their response and management speed when facing real-life emergencies with patients, thereby reducing the occurrence of adverse events such as neonatal seizures and cerebral palsy, effectively ensuring the safety of mother and baby during the perinatal period.

The product consists of two parts: The student terminal- the simulated fetal heart rate monitor (FHR monitor), and the instructor terminal-control monitor- the simulated fetal monitor controller.

Hardware Function

· Similar in appearance to real FHR monitor;

1) Features a high-precision 13.3-inch LCD screen with a resolution of 1920*1080, providing clear display of waveforms and parameters;

2) Touchscreen facilitates easy setup and parameter adjustment.

· The device surface features power on/off, help, alarm mute, home, back buttons, and a navigation switch knob.

1)      Power on/off button:

After connecting to the AC power/installing a charged battery, press to turn on; while powered on, press to turn off;

2)      Help button:

For network and language settings

3)      Mute alarm button:

Press to mute all currently alarming parameters on the monitor; press again to release the current mute status.

4)      Home button:

Press to quickly return to the home screen interface

5)      Back buttons

Press to go back to the previous step.

6)      Navigation switch knob

Continuously variable design enables rotation in both directions to focus on a specific function. Press to confirm and perform the selected action.

· Alarm

When parameters exceed the threshold set for alarms the set alarm thresholds, the speaker can emit an alarm sound and the parameters will flash.

★· Two power supply methods are available: either using an AC power source or installing a rechargeable battery. The fully charged built-in battery can be used for 3 hours and supports manual insertion put in or removal within 10 seconds.

· The monitor is equipped with 3 probe interfaces (2 for FHR and 1 for uterine contractions). A prompt will display if each probe is connected. After placing and securing the probes on the abdomen of an SP or manikin, the screen will display the corresponding waveforms and data.

· HDMI output: the built-in conversion module can connect an HDMI cable to project screen data onto a larger screen other screens.

· The power indicator light can alert users to the current power status of the device.

Software Function

· The current patient’s gestational age and age could be displayed, making the simulation scenario more realistic.

· During a singleton pregnancy, the interface displays FHR1 and UA waveforms and their corresponding values. During a twin pregnancy, the interface displays FHR1, FHR2, and UA waveforms and their corresponding values, with yellow and red colors used to distinguish between FHR1 and FHR2 waveforms and values.

· The interface dynamically displays FHR monitoring data, accommodating up to 36 minutes of the latest FHR monitoring data in real-time, with waveforms refreshing from the right side.

· Clicking “Pause/Run” can lock the waveforms and data currently displayed on the screen. Clicking the button again allows the waveforms to quickly transition to the latest interface.

· Review of previous FHR monitoring data: Depending on the paper feed, each click of the “Left”/”Right” button moves the screen waveform by a time length of 12 minutes, 18 minutes, or 36 minutes. When the waveform is at the latest time point, the “Right” button is disabled; when the waveform is at the initial time point, the “Left” button is disabled.

· Alarm settings: It supports to set the alarm status (on/off), alarm range (30bpm～240bpm freely set) and alarm volume (0～7) for FHR1 and FHR2 separately; alarm status (on/off), alarm range (0mmHg～100mmHg freely set) and alarm volume (0～7) can also be set for UA .

· When the FHR or UA values exceed the set alarm range, the values in the interface will flash, and the interface will dynamically display the latest alarm log. The alarm effect is realistic and significant; the alarm sounds of FHR1, FHR2, and UA can be turned off separately.

· Adjustable paper feed: The default paper feed is 3cm/min, but it can also be set to 2cm/min or 1cm/min to suit the usage habits of obstetricians in different countries or regions.

· Review of historical training data: Up to 10 historical training data can be viewed, each containing elements such as case name, training time, and training duration, aiding in debrief and review.

· Printing of waveforms: The simulated FHR monitoring charts could be printed.

The Instructor Control Terminal

· The instructor can view the patient information (name, age, height, weight, etc.) of the running case and total running time, and control the running state of the case (to pause or end).

· FHR monitoring can be set at 0.5x, 1x, 2x, 4x, and 10x speeds, flexibly presenting the FHR monitoring curve.

· Three special conditions, including labor arrest, shoulder dystocia, and nuchal cord, are preset and can be activated with to apply to the current running case.

· The CTG switch can be controlled, and after turning on, it is possible to separately set whether the waveforms and data of the three parameters—FHR1, FHR2, and UA—are displayed on the trainee monitoring side.

★· The control terminal can adjust the parameter values to influence trigger the changes in FHR and uterine contraction curves.

1)      FHR monitor supports seamless adjustment between 30 to 240bpm through infinite sliding, and also allows direct numerical input.

2)      The amplitude value of FHR supports seamless adjustment between 0 to 100bpm through infinite sliding, and also allows direct numerical input. The change range can be selected among three levels: "None", "15-40", and ">40".

3)      FHR acceleration/deceleration time supports seamless adjustment between 10 to 360s through infinite sliding, and also allows direct numerical input.

4)      Baseline/Intermittent time FHR supports seamless adjustment between 10 to 360s through infinite sliding, and also allows direct numerical input.

5)      Intrauterine static pressure supports seamless adjustment between 0 to 50mmHg through infinite sliding, and also allows direct numerical input.

6)      Intrauterine pressure supports seamless adjustment between 10 to 100mmHg through infinite sliding, and also allows direct numerical input.

7)      Contraction duration supports seamless adjustment between 10 to 120s through infinite sliding, and also allows direct numerical input.

8)      Contraction interval supports seamless adjustment between 0 to 360s through infinite sliding, and also allows direct numerical input.

9)      Noise level supports seamless adjustment between 0 to 1, through infinite sliding, and also allows direct numerical input.

· The system has built-in multiple types of FHR and contraction waveforms, which can be expanded as needed.

1)      The system is preset with 5 types of baseline FHR waveforms, including absent baseline variability, minimal baseline variability, normal baseline variability, marked baseline variability and sinusoidal waveforms. The library supports expansion.

2)      ★The system is preset with a waveform library containing 28 types of FHR acceleration/deceleration waveforms, covering various types such as periodic acceleration, non-periodic acceleration, early deceleration, late deceleration, prolonged deceleration, and variable deceleration. The library supports expansion.

3)      ★The system is preset with a waveform library containing 25 types of contraction waveforms, including Type I waves, Type II waves, Type III waves, spike waves, bimodal contractions, hypertonic contractions, and hypotonic contractions among others. The library supports expansion.

4)      The system is preset with 3 types of contraction interval waveforms, including intervals with minor fluctuations, intervals with fluctuations, and intervals accompanied by fetal movement. The library supports expansion.

★· The system supports custom editing, saving, and deleting of waveforms: based on the original preset waveform library, new waveforms can be copied and created according to clinical teaching needs, and customized editing can be done by dragging adjustment points; newly created waveforms can be renamed, saved, and deleted.

1)      Custom-created waveforms can be configured to set the temporal association between fetal heart rate and uterine contractions, including synchronization of fetal heart rate with contractions, fetal heart rate lagging behind contractions, and no correlation between fetal heart rate and contractions.