MCF-21 B Series Fetal Monitor (CTG)

Technical Data Sheet - Release V2.6

The Unicare MCF-21 B Series An optional USB Mouse/Keyboard

high-tech fetal monitor offers a control eases navigation and data
reliable, high-performance solution for entry.
fetal monitoring needs in doctors’ An optional USB port offers patient
practices, clinics and hospitals, from data/NST report backup.
pre-natal check-ups to antepartum
monitoring of high-risk pregnancies. An optional Non-Stress Test (NST)
report software eases documentation
in antepartum monitoring.

UNICARE
CE/ISO/RoHS/CFDA
Features
Core • Optional Support HL7 (Health Level Seven)
• Newly advanced A9 main board with Linux OS,
calculating speed is 4 times faster than traditional Alarm
products • Three-level acousto-optic alarm
• Support storage of 25000 groups of medical record and • FHR signal strength prompt
8640 hours trend review • Cross-Channel Verification (CCV) provides visual
and audible indication when it detects synchronous fetal
Body or maternal heart rate signals, indicating that you may be
• 12.1 inch Folded high-brightness TFT LED monitoring a duplicate signal)
• Optional touch screen • Sensor-off alarm
• Humanized probe frame design • Paper out alarm
• Support alarm review
Sensor
• 12-Crystal ultrasound transducer achieves a wider Linux OS
focal region for more uniform coverage at greater depths • Support operation with mouse and computer
than conventional 9-crystal. 12-crystal ultrasound design keyboard (option)
can also get good result even when the patient varies her • Multi-display mode to meet different clinical
position and shape requirement, including Fetal-parameter interface,
Maternal-parameter interface, Fetal/Maternal-parameter
• Optional waterproof FHR transducer for underwater interface, as well as big font, alarm review, ECG review,
birth trend table, trend graph and OxyCRG display.
• Event Marker for easy documentation of events and
kick counts. Auto-fetal-movement detector is also • NIBP self-test mode: including overpressure test,
available. static pressure test and air leakage test.
• Use of signal strength indicator to position the • On-screen scrolling for viewing stored fetal traces
ultrasound transducers at the optimum location on the • Generate ID automatically when register a new patient
patient • Support medical history search by patient ID, name
and mobile number
Printer • NST Timer
• Built-in high-speed thermal printer, printing width can be • Fetal Movement Profile (FMP) detects and
set to 112mm, 150mm, can meet both US standard automatically records gross fetal body movements
and European standard (Brand: SEIKO, Japan) • Heart rate offset mode allowing you to offset FHR2
± 5~30BPM.
• Support fast printing of stored trend • Support multi-language display
• Advanced Fischer NST Report (Fetal Health
Central System Report)
• Optional Build-in wireless network module, • Support online software upgrading by net/USB
supporting wired or wireless connection to the central • Optional patient data/NST Report backup by USB
monitoring station. in PDF format
Interface Related Product
Transducer socket
• US1 (FHR1)
• US2 (FHR 2)
• TOCO
• FM (Manual Fetal movement)
• ECG (Maternal ECG)
• TEMP (Maternal temperature)
• SPO2 (Maternal SpO2) • The monitor is compatible with Acoustic Fetal
• NIBP (Maternal NIBP) Stimulator, which use low frequency vibro-acoustic stimuli
(VAS) to “wake” the fetus, increasing the efficiency of
LAN / Central monitor system interface antepartum testing and improving retest consistency.
• The LAN port is for connecting the monitor to a central
monitor system network.

Input device interface

• This optional interface provides two 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.] • The fetal monitors can be equipped with NST (Non Stress
Test) Report function (option) based on Fischer evaluation
• Knob (Standard) method to give a score of fetal wellbeing after 20 minutes
• Touch screen (optional) continuous monitoring, thus helping the doctors make
[Remark: Touch screen can not be used simultaneously with judgment about fetal health condition.
mouse / computer keyboard.]

• Base line, LTV Amplitude, Period, Acceleration, and

Service Features Deceleration are 5 indexes of analyzing FHR wave, the
software allows interpretation of fetal heart Rate and TOCO
• The Support Tool helps technical personnel to
traces, and generates a printed report automatically for a
– carry out configuration, upgrades and troubleshooting on
reassuring NST
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.
Performance Specifications

Dimension and Weight Ultrasound (FHR) Maternal Respiration

- Dimension: 360mm*310mm*120mm - Transducer type: 12-Crystal ultrasound transducer - Method: Impedance between RA-LL, RA-LA

- Weight: 5.3kg（excluding accessories） - Measure method: Wide beam pulse doppler - Gain: ×0.25, ×0.50, ×1, ×2, ×4
Power Supply - FHR Measurement range:
- Respiration Rate: 0bpm, 6 ~ 150 bpm
- Voltage: AC100～240V, 50/60HZ 30 to 240 bpm (US Standard)
- Resolution: 1 bpm
Display 50 to 210 bpm (Europe Standard)
- Accuracy: ±2 bpm or ±2%, whichever is greater
- Accuracy: ±1 bpm
- 12.1" color TFT LED (0-90° rotation) - Apnea Alarm: 10 ~ 60 s
- Intensity: ＜3 mW/cm2
- Resolution: 1024*768 pixels Maternal SpO2 (Digital Technic)
- Ultrasound frequency: 1MHz±3%
Battery (Built-in) - Measurement Range: 0 ~ 100 %
- Resolution: 1 bpm
- Type: Rechargeable lithium battery 14.8V/2200mAh - Resolution: 1 %
TOCO
- Charge Cycle: ≥500 times - Accuracy: ±2% (70% ~ 100%)
- Measurement method: Strain gauge sensor element
- Working time: 2 hours ±3 % (35% ~ 69%)
- Measure range: 0 ~ 100 units
Unspecified (0 ~ 34%)
- Resolution: 1 unit
Recorder (Built-in) Pulse Rate
- Nonlinear deviation : ≤±8%
- Method: Thermal printer - Range: 25~250bpm
- Baseline setting: 0,5,10,15, 20 can be selected
- Paper: Z-fold, thermosensitive - Accuracy: ±1% or ±1 bpm, whichever is greater
- Auto offset correction: 3 second after connecting the
- Paper width: 112 mm (4.41 in)/150 mm (5.91 in) - Resolution: 1bpm
transducer
- Printing speed: 1/2/3cm/min
- Auto zero adjust: TOCO value is set to zero negative
Maternal NIBP (MNIBP)
- Trace: Max. 4 tracks
following a negative Measure value for 5 seconds - Method: Oscillometric
- Recording way: Real-time Recording, Review Printing
Fetal Movement Recording - Measure mode Manual, Auto, STAT
Alarm - Measure Interval in AUTO Mode 1~480 min
- Automatic fetal movement (AFM): pulsed doppler
- Level: Low, medium and high - STAT mode cycle time: Keep 5 minutes, at 5
ultrasound
- Indication: Auditory, Visual, Delay of FHR Alarm seconds interval
- Automatic fetal movement autograph
Input Device - Measure and Alarm Range:
- Manual fetal movement marker (MFM)
- Touch screen (option) Systolic: 30~270 mmHg
Maternal ECG
- Knob (Standard) Diastolic: 10~220 mmHg
- Lead mode: 3/5 Leads, I, II, III or I, II, III, AVR, AVL,
- Keypad input (Standard) Mean: 20~235 mmHg
AVF, V
- Mouse/ Keyboard input (option) - Static pressure accuracy ±3mmHg
- Gain: 2.5mm/mV, 5.0mm/mV, 10mm/mV, 20mm/mV,
- USB port for patient data/NST report backup - Resolution: 1mmHg
40mm/mV, Auto
(option) - Accuracy: Maximum Mean error ±5mmHg
- Sweep speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
System Output & Extensible Maximum Standard deviation 8mmHg
- Accuracy: ±1bpm/ ±1%, whichever is greater
Interface - Resolution: 1 bpm
- Over pressure Protection: Dual protection via

software & hardware

- Ethernet Network: 1 standard RJ45 socket - Leakage Current < 10 µA
- USB Port: 2
Maternal Temperature
- CMRR: Diagnostic Mode >89 dB
- Video Output: 1 HDMI port (option) - Technique: Thermistor probe (2.25K)
Monitor Mode >105 dB
Trend & Reviewing Surgery Mode >105 dB
- Measuring and Alarm Range: 0.0 ℃~ 50 ℃ (32℉~
122℉)
- Cardiotocography (CTG): - Bandwidth: Surgery 1 ~ 25 Hz
- Unit: Celsius (℃), Fahrenheit ( ℉)
Waveform Review: 8640 hours Monitor 0.5 ~ 40 Hz
- Resolution: 0.1℃
- Vital Signs: Diagnostic 0.05 ~ 120 Hz
- Accuracy: ±0.1℃
Trend: 2160 hours Maternal Heart Rate
Waveform Review: 2 hours
NST Report/FHR Interpretation
- Measure range: Adult: 0bpm; 10 ~ 300 bpm
NIBP Review: 2000 groups Neonate: 0bpm; 10 ~ 350 bpm
(Option)
- Alarm Review: 2000 groups - Resolution: 1 bpm - Based on Fischer Evaluation Method (monitoring time

Safety - Accuracy: ± 1% or ± 1bpm, whichever is greater ≥20 Min)

- IEC60601-1 Approved, CE marking according to ST Measurement - Average Baseline FHR / Number of Acceleration /

MDD93/42/EEC Number of Deceleration / Number of Small

- Range: -2.0 ~ +2.0 mV
- With reference to RoHS Directive 2011/65/EU Acceleration / Amplitude Variation / Number of PV
- Accuracy: -0.8mV ～ +0.8mV: ±0.02mV or ±10%,
recasting - Automatic Score Result: Sore: 8-10 (Excellent)
whichever is greater
Sore: 5-7 (Suspicious)
- Other range: unspecified
Score:≤4 ( Fetus Hypoxia)
- Resolution: 0.01mV
* Specifications subject to change without prior notice
Model Configuration
Fetal Parameter Maternal Parameter Printer Paper Width Battery

Model AFM
Single Dual Signal Overlap 112mm 112mm 150mm 150mm Lithium
TOCO & NIBP, SpO2, PR ECG, TEMP, RESP
FHR FHR Alarm A type B type A type B type battery
MFM

Config. A ● N/A ● ● N/A N/A N/A ● Opt Opt Opt ●

MCF-21 B Config. B ● ● ● ● ● N/A N/A ● Opt Opt Opt ●
(12.1 inch) Config. C ● N/A ● ● ● ● ● ● Opt Opt Opt ●
Config. D ● ● ● ● ● ● ● ● Opt Opt Opt ●
1) HDMI 2) Touch Screen 3) Fetal Stimulator 4) Wall-mount 5) Trolley
Option: 6) Waterproof FHR Probe & 7) Central Monitoring Station 8) Keyboard & Mouse control 9) Advanced Fischer NST Report 10) USB port with patient
TOCO Probe function data/NST report backup function
Remark: The touch screen and mouse/ computer keyboard is not compatible by now.
Table legend: ： ●-Standard , N/A – not applicable

Gallery for Optional Accessories:

FHR Transducer TOCO Transducer Event Marker Fetal Acoustic Stimulator Central Monitoring Station Reusable Transducer Belt NIBP Cuff and NIBP Tube SpO2 Transducer

112(A) mm Thermal Paper 112(B) mm Thermal Paper 150 (A) mm Thermal Paper
150 (B) mm Thermal Paper
Temperature (112mm×100mm×150p, (112mm×100mm×150p, (150mm×100mm×150p,
(150mm×100mm×150p,
Transducer (Skin / European Standard, USA Standard, 30-240 bpm) European Standard,
ECG Cables
USA Standard, 30-240bpm)
Rectal type) Trolley with Basket 30-210 bpm) 50-210bpm)
Wall-mount with basket
Standard Packing List:

Standard Packing List Config. A Config. B Config. C Config. D

No. Parts No. Description QTY QTY QTY QTY
1 8310400004 FHR Transducer 1 2 1 2
2 8310400003 TOCO Transducer 1 1 1 1
3 8310400012 Event Marker 1 1 1 1
4 8189007066 Belt 2 3 2 3
5 8111810003 Recording Paper
2 2 2 2
(112mmx100mmx150p, European Standard)
6 8112900002 Power Cord 1 1 1 1
7 8510100002 User Manual 1 1 1 1
8 8510120001 Checking List 1 1 1 1
9 8310100008 Ground Cable 1 1 1 1
10 8189007074 Adult NIBP cuff with connector, Sac-type (for 25-35cm) 0 0 1 1
11 8189007010 NIBP Extension Hose 0 0 1 1
12 8310400014 Reusable Adult SpO2 Probe 0 0 1 1
13 8189007072 Skin Temperature Probe, 2.25K 0 0 1 1
14 8310400019 ECG Cable 0 0 1 1
15 8189007002 ECG Electrodes (25 pcs/package) 0 0 1 1
Options:
No. Parts No. Description
NST Report
1 N/A Fisher NST Report (Fetal Health Report)
Transducer
2 8310400004 FHR Transducer
N/A Waterproof FHR Transducer
3 8310400003 TOCO Transducer
N/A Waterproof TOCO Transducer
4 8310400012 Event Marker
Recording Paper
5 8111810003 Recording Paper (112mmx100mmx150p, European Standard, per piece)
Recording Paper (112mmx100mmx150p, US Standard, per piece)
6 8111810024 Recording Paper (150mmx100mmx150p, European Standard, per piece)
7 8111810022 Recording Paper (150mmx100mmx150p, US Standard, per piece)
Temperature
8 8189007072 Skin Temperature Probe, 2.25K
9 8189007005 Rectal Temperature Probe, 10K
NIBP
10 8189007010 NIBP Extension Hose
11 8189007074 Adult NIBP cuff with connector, Sac-type (for 25-35cm)
[for other special size, please contact the salesman.]
ECG
12 8310400019 ECG Cable
13 8189007002 ECG Electrodes (25 pcs/package)
SPO2
14 8310400014 Unicare Reusable Adult SPO2 sensor with plug
Others
15 8112600002 Touch Screen
16 N/A Computer Keyboard
8490000047 Mouse
17 USB port for patient data/NST report backup
18 8600000001 Central Monitoring Station (software + dongle)
19 8212010009 Rechargeable Lithium-ion Battery
20 8490000012 Fetal Acoustic Stimulator
21 8189007066 Belt (per piece)
22 8190100001 Ultrasound Gel (250g)
23 8212900052 Wall Mounting Rack with Basket
24 8510110002 Service Manual
25 8490000001 Trolley with basket and wheels
26 8700010103 Net Cable for Central Station (5M)
27 8112900002 Power Cord (3 pin)
28 8310100008 Ground Wire
29 N/A HDMI Output
30 N/A HDMI to VGA transverter
31 N/A USB Input Function (support USB Mouse/Keypad input and control)
N/A USB Output Function (patient data backup by USB and NST report)
32 8490000031 Wireless AP (transmitter & Receiver) (for wireless central monitor system)
33 8490000030 Wireless AP (transmitter) (for wireless central monitor system)
34 9100010003 Switch Board
* Contents are subject to change without prior notice
Shenzhen Unicare Electronic Co., Ltd.

Add: 3D, Building4, Tian-an Industrial Zone, Nan You,

Nanshan District, Shenzhen, 518054, P.R. China

Tel: +86-(0) 755-3336 9088 / 3336 2088 / 3330 3188

Fax: +86-(0) 755-3336 6818

Email: market@unicare-med.com

Web: www.unicare-med.com/en

© 2016 Shenzhen Unicare Electronic Co., Ltd.

All rights are reserved.

Unicare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice

or obligation and will not be liable for any consequences resulting from the use of this publication.

Printed in The People’s Republic of China.

November 2016