Henan Forever Medical Co., Ltd.

10.4 Inches Fetal Monitor (FM-V2.5)

Technical Data Sheet - Release V2.5

The 10.4 inches high-tech fetal monitor offers a reliable, high-performance solution for fetal monitoring needs in doctors’ practices, clinics and hospitals, from pre-natal check-ups to antepartum monitoring of high-risk pregnancies.

An optional USB Mouse/Keyboard control eases navigation and data entry.

An optional USB port offers patient data/NST report backup.

An optional Non-Stress Test (NST) report software eases documentation in antepartum monitoring.

Features

Core

· Newly advanced A9 main board with Linux OS, calculating speed is 4 times faster than traditional products

· Support storage of 25000 groups of medical record and 8640 hours trend review

Body

· 10.4 inch Folded high-brightness TFT LED

· Optional touch screen

Sensor

· 12-Crystal ultrasound transducer achieves a wider focal region for more uniform coverage at greater depths than conventional 9-crystal. 12-crystal ultrasound design can also get good result even when the patient varies her position and shape

· Optional waterproof FHR transducer for underwater birth

· Event Marker for easy documentation of events and kick counts. Auto-fetal-movement detector is also available.

· Use of signal strength indicator to position the ultrasound transducers at the optimum location on the patient

Printer

· Built-in high-speed thermal printer, printing width can be set to 112mm (Brand: SEIKO, Japan)

· Support fast printing of stored trend

Central System

· Optional Build-in wireless network module, supporting wired or wireless connection to the central monitoring station.

· Optional Support HL7 (Health Level Seven)

Alarm

· Three-level acousto-optic alarm

· FHR signal strength prompt

· Cross-Channel Verification (CCV) provides visual and audible indication when it detects synchronous fetal or maternal heart rate signals, indicating that you may be monitoring a duplicate signal)

· Sensor-off alarm

· Paper out alarm

· Support alarm review

Linux OS

· Support operation with mouse and computer keyboard (option)

· Multi-display mode to meet different clinical requirement, including Fetal-parameter interface, Maternal-parameter interface, Fetal/Maternal-parameter interface, as well as big font, alarm review, ECG review, trend table, trend graph and OxyCRG display.

· NIBP self-test mode: including overpressure test, static pressure test and air leakage test.

· On-screen scrolling for viewing stored fetal traces

· Generate ID automatically when register a new patient

· Support medical history search by patient ID, name and mobile number

· NST Timer

· Fetal Movement Profile (FMP) detects and automatically records gross fetal body movements

· Heart rate offset mode allowing you to offset FHR2 ± 5~30BPM.

· Support multi-language display

· Advanced Fischer NST Report (Fetal Health Report) 

· Support online software upgrading by net/USB

· Optional patient data &NST Report backup by USB in PDF format

Interface

Transducer socket

· US1 (FHR1)

· US2 (FHR 2)

· TOCO

· FM (Manual Fetal movement)

· SPO2 (Maternal SpO2)

· NIBP (Maternal NIBP)

LAN / Central monitor system interface

· The LAN port is for connecting the monitor to a central monitor system network.

Input device interface

· This optional interface provides an USB ports to enable the monitor to be connected to off-the-shelf input devices as well as support patient data & NST Report backup (option):

· Mouse: any specified trackball or USB mouse may be used for navigation and data entry.

· Computer keyboard: an USB computer keyboard can be used for data entry instead of the on-screen pop-up keyboard.

[Remark: user has to restart the machine after plug and unplug the mouse / computer keyboard.]

· Touch screen (optional)

[Remark: Touch screen can not be used simultaneously with mouse / computer keyboard.]

Service Features

· The Support Tool helps technical personnel to

–  carry out configuration, upgrades and troubleshooting on an individual monitor.

– back up the monitor settings.

· The Service Mode is password-protected and ensures that only trained staff can access service tests and tasks. It includes Printer Setting, Skin Type, AFM Setting, Brightness Setting, Clear Data, NIBP Calibration, and Touch Screen Calibration.

· The Support Tool uses the USB interface of the fetal monitor for software upgrading.

Related Product

· The monitor is compatible with Acoustic Fetal Stimulator, which use low frequency vibro-acoustic stimuli (VAS) to “wake” the fetus, increasing the efficiency of antepartum testing and improving retest consistency.

· The fetal monitors can be equipped with NST (Non Stress Test) Report function (option) based on Fischer evaluation method to give a score of fetal wellbeing after 20 minutes continuous monitoring, thus helping the doctors make judgment about fetal health condition.

· Base line, LTV Amplitude, Period, Acceleration, and Deceleration are 5 indexes of analyzing FHR wave, the software allows interpretation of fetal heart Rate and TOCO traces, and generates a printed report automatically for a reassuring NST.

Performance Specifications

Dimension and Weight

- Dimension: 320mm*260mm*80mm

- Weight: 2.8kg（excluding accessories）

Power Supply

- Adapter:  Output 9VDC, 5A

- Voltage: AC100～240V, 50/60HZ

Display

- 10.4" color TFT LED  (0-135° rotation)

- Resolution: 800*600 pixels

Battery (Built-in)

- Type: Rechargeable lithium battery

- Charge Cycle: ≥500 times

- Working time: 2 hours (optional larger battery for 4-5 hours)

Recorder (Built-in)

- Method:  Thermal printer

- Paper: Z-fold, thermosensitive

- Paper width: 112 mm (4.41 in)

- Printing speed: 1/2/3cm/min

- Trace: Max. 4 tracks

- Recording way: Real-time Recording, Review Printing

Alarm

- Level: Low, medium and high

- Indication: Auditory, Visual, Delay of FHR Alarm

Input Device

- Touch screen (option)

- Keypad input (Standard)

- Mouse/ Keyboard input (option)

- USB port for patient data/NST report backup (option)

System Output & Extensible Interface

- Ethernet Network: 1 standard RJ45 socket

- USB Port: 1

Safety

- IEC60601-1 Approved, CE marking according to MDD93/42/EEC

- With reference to RoHS Directive 2011/65/EU recasting

Trend & Reviewing

- Cardiotocography (CTG):  

Waveform Review:  8640 hours

- Vital Signs:  

Trend: 2160 hours

Waveform Review: 2 hours

NIBP Review: 2000 groups

- Alarm Review: 2000 groups

Ultrasound (FHR)

- Transducer type: 12-Crystal ultrasound transducer

- Measure method: Wide beam pulse doppler

- FHR Measurement range:  

30 to 240 bpm (US Standard)

    50 to 210 bpm (Europe Standard)

- Accuracy: ±1 bpm

- Intensity: ＜3 mW/cm2

- Ultrasound frequency: 1MHz±3%

- Resolution: 1 bpm

TOCO

- Measurement method:  Strain gauge sensor element

- Measure range: 0 ~ 100 units

- Resolution: 1 unit

- Nonlinear deviation : ≤±8%

- Baseline setting: 0,5,10,15, 20 can be selected

- Auto offset correction: 3 second after connecting the transducer

- Auto zero adjust: TOCO value is set to zero negative following a negative Measure value for 5 seconds

Fetal Movement Recording

- Automatic fetal movement (AFM): pulsed doppler ultrasound

- Automatic fetal movement autograph

- Manual fetal movement marker (MFM)

Maternal SpO2 (Digital Technic)

- Measurement Range: 0 ~ 100 %

- Resolution: 1 %

- Accuracy:  ±2% (70% ~ 100%)

            ±3 % (35% ~ 69%)

            Unspecified (0 ~ 34%)   

Pulse Rate

- Range: 25~250bpm

- Accuracy: ±1% or ±1 bpm, whichever is greater

- Resolution: 1bpm

Maternal NIBP (MNIBP)

- Method: Oscillometric

- Measure mode Manual, Auto, STAT

- Measure Interval in AUTO Mode 1~480 min

- STAT mode cycle time:  Keep 5 minutes, at 5 seconds interval

- Measure and Alarm Range:

Systolic: 30~270 mmHg

Diastolic: 10~220 mmHg

Mean: 20~235 mmHg

- Static pressure accuracy ±3mmHg

- Resolution: 1mmHg

- Accuracy: Maximum Mean error ±5mmHg           

         Maximum Standard deviation 8mmHg

- Over pressure Protection: Dual protection via software & hardware

NST Report/FHR Interpretation (Option)

- Based on Fischer Evaluation Method (monitoring time≥20 Min)

- Average Baseline FHR / Number of Acceleration / Number of Deceleration / Number of Small Acceleration / Amplitude Variation / Number of PV

- Automatic Score Result: Sore: 8-10 (Excellent)

                      Sore: 5-7 (Suspicious)

                      Score:≤4 ( Fetus Hypoxia)