MMP12

Multi-parameters Module

MMP12
Multi-parameter
Module
V3.0

Overview
The MMP12 integrated 12 Leads ECG Multi-Parameters module can provide
measurement for ECG, respiration, temperature, blood pressure, blood oxygen,
pulse, etc. The measurement method of ECG: the heart first generates electrical thrill
before mechanical contraction, which generates biological current and conducted to
the body surface. ECG signal is the dynamic curve recording surface potential difference
that caused by different potentials changes in different body site. Impedance respiration
is measured across the thorax. When the patient is breathing or ventilated the volume of
air changes in the lungs, resulting in impedance changes between the electrodes. Respiration
rate (RR) is calculated from these impedance changes. Thermistors are used to monitor skin
temperature. The method of blood oxygen measurement is based on the absorption of selected
wavelengths of light. The light generated in the probe passes through the tissue and is converted
into electrical signals by the photodetector in the probe. The SpO2 module processes the electrical
signal and displays a waveform and digital values for SpO2 and pulse rate. The measurement of non-
invasive blood pressure is based on the principle of oscillation method. Wave of pressure pulse is
detected as the cuff being quickly inflated and deflated; the cuff is tied on limbs. After processing the
oscillation signals and calculation, parameters concerning mean pressure, systolic and diastolic pressures,
pulse rate are obtained.
Application
• SpO2, NIBP, 12 Leads ECG, Temperature, Respiration Rate, PR functions of patient monitor and emergency
transport monitors.
Functions
ECG measurement
• The result of ECG measurement maximum sup-
port 12leads ECG waveform includes heart rate,
body temperature, respiration, and ST-segment
deviation value of channel I, II and V1 as well as
the arrhythmia.
• Four measurement modes are provided: diagno-
sis, monitoring, HARDEST and operation.
• Three patient models are supported: adult, pedi-
atric and neonate.
The range of filtering in mode
Diagnosis
of diagnosis is 0.05hz-130hz
The range of filtering in mode
Monitoring
of monitoring is 0.5hz-40hz
The range of filtering in mode
HARDEST
of HARDEST is 5hz-20hz
The range of filtering in mode of
Operation
operation is 1hz-25hz
SpO2 measurement
• Real time measurement of SpO2, heart rate and
perfusion index (PI).
• Real-time transmission of pulse wave signals
based on infrared spectrum absorption.
• Real-time transmission of module’s state on
working, hardware, software and sensor.
• The host can issue an alarm according to rele-
vant information.
• Three patient models are supported: adult, pedi-
atric and neonate.
• Average time setup for parameters calculation
to obtain different response times of parameter
calculations.
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• Calibration for ECG: input 1mv standard voltage
to record waveform amplitude.
• Channel of Heart rate calculation/Arrhythmia
analysis: Heart Rate I, II and V1 as well as self-se-
lect are for selection.
• Notch Mode: 50 Hz, 60 Hz, and 50/60 Hz and off
are for selection.
• Interval measurement of ECG waveform charac-
teristic are supported: involving measurement of
PR interval, QRS interval, QT interval, QTC, P axis,
QRS electrical axis and T axis as well as amplitude
measurement of RV5, SV1.
• Printable diagnostic analysis are provided includ-
ing arrhythmia, conduction block, myocardial in-
farction, STT variations, ventricular hypertrophy,
atrial enlargement, electrical axis deviation and
other cardiac diseases.
• The ability of anti-motion interference and weak
signal measurement.
Manual Once measurement under one command
Auto-measurement at regular intervals,
1min, 2min, 3min, 4min, 5min, 10min,
15min, 30min, 60min, 90min, 2h, 3h, 4h,
8h are for selection. The periodic time is the
STAT time interval between two measurements.
If the interval from measurement ending to
next measurement starting is less than 30
seconds, it will be automatically extended to
30 seconds
Continuous measurement lasts 5
Continuous minutes, with a 5s interval between two
measurements
2
 NIBP measurement
• The systolic pressure (SYS), mean pressure (MAP),
diastolic pressure (DIA) and heart rate (PR) are
included in measurement results.
• Three measurement modes are provided: manual,
automatic (STAT) and continuous.
• Three patient models are supported: adult, pedi-
atric and neonate.
• Pressure calibration: continuous cuff pressure is
provided to calibrate accuracy.
• Leakage test: detect the integrity of airway.
• Anti-motion interference and weak signal meas-
urement.
• High reliability and accuracy.
• Real-time transmission of module’s state on work-
ing, hardware, software and sensor. The host can
issue alarms according to relevant information.
• Double overvoltage protection (hardware and
software).
• Double time-out protection (module time-out
protection, providing timing trigger port for host).

Performances
ECG

Range...........................................................................................................................0 – 100 %
Range of measurement Base resistance value........................................................................................ Undefined
Variable resistance value........................................................................................ 1%

Range..........................................................................................................15-300 bpm (adult)

.................................................................................................. 15-350 bpm (pediatric/neonate)
Range of PR
Accuracy......................................................................................................................... ±1bpm
Resolution.................................................................................................................. 1bpm

Noise .................................................................................................................. < 30 uv(peak-to-valley)

Input impedance .............................................................................................................................................> 5 MΩ

Diagnosis........................................................................................................................ ≥90 dB
Common-mode rejection Monitoring.................................................................................................................. ≥100 dB
Operation............................................................................................................... ≥100 dB

Voltage range of ........................................................................................................................................... ±400mV

electrode polarization

Baseline recovery time ..................................................................................................................< 3s after defibrillation

Detection amplitude..................................................................................... ±2 ~±700 mV

Detection for pacer signal Pulse width............................................................. standard requirement--(0.1 ms-2.0ms)
Rise Time...........................................................................................................10us-100us

Cut mode......................................................................................................................... 300 W

Electrotome protection Noise suppression for electrotome.............................................................................
Under the guidance of IEC 60601-2-27, article 5.2.8.14, the peak-to-valley noise tested with
standard ECG lead wire is less than or equal to 2mV compared with the baseline

Remove the maximum and minimum values of recent 12 RR intervals, and calculate the
Mean algorithm of HR mean value

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 Figure 3a (Ventricular Bigeminy).................................................................80±1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy)............................60±1 bpm
Response to irregular rhythm
Figure 3c (Rapid Alternating Ventricular Bigeminy).................... 120±1 bpm
Figure 3d (Bi-directional Systoles).......................................................... 90±2 bpm

Conform to requirement......................................................................... IEC 60601-2-27

Response time of change
Heart rate from 80-120bpm.................................................................no more than 7s
in heart rate
Heart rate from 80-40bpm............................................................... no more than 7s

Time to alarm for tachycardia .......................................................................................................................... no more than 10s

Tall T-wave rejection The maximum T-wave amplitude (aT) meet the requirement of 1.2mv specified in IEC
capability 60601-2-27

Range................................................................................................................................. 0-300
PVCS (statistics of
Accuracy................................................................................................................................ No
premature beat)
Resolution........................................................................................................................ ±1

................................................................................................................ Asystole, fibrillation (VF)

...................................................................................................Ventricular tachycardia, R ON T
.......................................................................................................Multiple VPB and Couple VPB
....................................................................................................... Accidental VPB and bigeminy
............................................................................ Trigeminy and supraventricular tachycaridia
.....................................................................................................Supraventricular bradycaridia
Category of arrhythmia ...............................................................................................................................Multi Form VPB
............................................................................................................................Pace not capture
............................................................................................................................. Pacer not paced
............................................................................................................................ Irregular rhythm
.....................................................................................................................................Missed beat
.........................................................................................................................................PVCs/min

Measurement range.......................................................................................- 2.0~2.0 mV

Accuracy............................................... within the range of -0.8-0.8 mV,±0.02 mV or 10 %,
choose the bigger one; other ranges are not defined
Analysis of ST-segment
Update time...................................................................................................................10s
On the ST template, the user can change the measurement place of ST values by adjusting
the sites of ISO and ST

Respiration SpO2
Range of RR......................................................... 0-120 rpm
Range of measurement..................................... 0-100%
Accuracy............................... 15-120 rpm: ±2 rpm or ±2 %;
Accuracy........................................................70-100%, ±2%;
Below 15rpm: not Defined
70 % or below, no definition
Base impedance...........................................500-2000 Ω
Resolution..................................................................... 1%
Variable impedance....................................... 0.2-3.0 Ω

Body temperature Pulse Rate (PR)

Range of measurement.......................................0-50°C Range of measurement..............................25–250bpm
Accuracy........................................................................±0.1C Accuracy.......................................................................... ±2%
Resolution................................................................. 0.1°C Resolution.................................................................1bpm

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 Perfusion Index (PI)
Range of measurement......................................0–20 %
Accuracy........................................................... No definition
Resolution.............................................................. 0.001%
Cuff pressure
Range of measurement........................... 0–300 mmHg
Accuracy................................. ±2mmHg or ±1% of reading
(take the bigger one)
Resolution................................................................1mmHg

Blood pressure and pulse rate

Patient
SYS MAP DIA PR
category

Adult 40–270mmHg 20–230mmHg 10–210mmHg 30–240bpm

Pediatric 40–200mmHg 20–175mmHg 10–162mmHg 30–240bpm

Neonate 40–130mmHg 20–100mmHg 10-90mmHg 40–240bpm

Measurement parameter Accuracy Resolution

The mean deviation <±5mmHg

Blood pressure value 1mmHg
The standard deviation <8mmHg

±2bpm or ±2% of reading

PR 1bpm
(take the bigger one)

Overpressure Protection
Protection pressure Protection pressure
Patient category
of software of hardware

Adult <297±3 mmHg <320±5mmHg

Pediatric <250±3 mmHg <260±5mmHg

Neonate <150±3 mmHg <160±5mmHg

Maximum limit time for blood pressure measurement

Adult < 120s

Pediatric < 120s

Neonate < 90s

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Standards compliance description
Regulation /
Number Name Version
Standard Number

IEC 60601-2-27.2005 Particular requirements for

1 IEC 60601-2-27 the safety, including essential performance, of 2005
electrocardiographic monitoring equipment

Testing and reporting performance results of

2 AAMI EC57 cardiac rhythm and ST segment measurement 2012
algorithms

Medical Electrical Equipment–Part2-25:

3 IEC60601-2-25 Particular requirements for the basic safety and 2011
essential performance of electrocardiographs

Medical Electrical Equipment–Part 2: Particular

1996
4 IEC60601-2-30 requirements for safety of automatic cycling
A1:1999
indirect blood pressure monitoring equipment

Non-invasive sphygmomanometers-Part 1:
5 EN1060-1 1995
General requirements

Non-invasive sphygmomanometers-Part 3:
6 EN1060-3 Supplementary requirements for electro- 1997
mechanical blood pressure measuring systems

Medical electrical equipment -- Part 2-61:

Particular requirements for basic safety and
7 ISO80601-2-61:2011 2011
essential performance of pulse oximeter
equipment

ISO 9919:2005 Medical electrical equipment-

Particular requirements for the basic safety
8 ISO9919 2010
and essential performance of pulse oximeter
equipment for medical use

Medical electrical equipment-Part

2-51:Particular requirements for safety,
9 IEC60601-2-51 including essential performance, of recording 2003
and analyzing single channel and multichannel
of electrocardiographs

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Electrical Characteristics
A single +12VDC input is provided externally, and the range of offset voltage
Power supply
should not exceed ±10% of the full-scale voltage.

Power Consumption ≤6W

Environment Characteristics

Working Environment Storage Environment

Temperature 10°C – 40°C (50°F – 104°F) -20°C – 70°C (4°F – 158°F)

Humidity 15 % – 90 % non-condensing 15 % – 95 % non-condensing

Latitude -170m – 1700m -170m – 1700m

Dimensions

Note: It is required that if the

protective earth and the isolated
port are installed on the same
conductor, the isolation port shall
be fixed with insulating screws.

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Interfaces
Power and communication Connector
The pins of power supply and communication inter-
face socket are defined as follows:

Pin Signal Description

The port J4/J10 of 12 leads ECG is defined as follows,
1 TXD Data transmission of UART
with the socket pin spacing of 2.54 mm:
2 RXD Data reception of UART

3 DGND 12V GND

Pin Signal Description
4 +12V 12V power input

5 DGND 12V GND 1 RL RL (right leg)

6 +12V 12V power input

2 ECG SHIELD Signal shielding wire
The power supply and communication interface sock-
et are defined as follows (Note: pin 4 and 6 are the The chest electrode: 4th Intercostal
3 V1
same input, pin 3 and 5 are the same) (IC) space at right border of sternum

4 LL LL (left leg)

5 LA LA (left arm)

6 RA RA (right arm)

Note 1: TXD is the data sent to the host by module M103.

Note 2: The distance of socket J1 is 2.54 mm. 7 —— Reserved

ECG leads input connector 8 V6

Left midaxillary line at the
horizontal level of V4
The port J4 of 3/5 leads ECG is defined as follows, with
Left midaxillary line at the
the socket pin spacing of 2.54 mm: 9 V5
horizontal level of V4

5th IC space on left midclavicular

Pin Signal Description 10 V4
line

1 RL RL (right leg)
11 V3 Midway between V2 and V4

2 ECG SHIELD Signal shielding wire

The fourth intercostal space at the
12 V2
The chest electrode: 4th Intercostal left edge of sternum
3 V1
(IC) space at right border of sternum

4 LL LL (left leg)

5 LA LA (left arm)

6 RA RA (right arm)

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The schematic diagram of lead electrodes is as follows:

SpO2 Sensor Connector

The interface socket J7 of sensor is defined as follows,
with the socket pin spacing of 2.0mm:

Pin Signal Description

1 1_WIRE Signal wires of probe identification

Temperature Sensor Connector 2 GND GND
The port J3 of temperature probe is defined as follows,
3 IR Positive pole IR LED
with the socket pin spacing of 2.54 mm:
4 RED Positive pole RED LED

Pin Signal Description 5 SpO2- Negative pole of optical signal

Temperature Sensor 1 6 SPO2+ Positive pole of optical signal

1 TEMP1
Positive input
Temperature Sensor 1
2 TGND
Negative input
Temperature Sensor 2
3 TEMP2
Positive input
Temperature Sensor 2
4 TGND
Negative input

Ordering
Our integrated 12 Leads ECG Multi-Parameters module part number is MMP12.
For ordering our module, please contact directly our website www.zugmed.com for further information.

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