MSLMP03 multi-parameter patient monitor specifications

1.Classification

Item

Specification

SFDA classification

Class II

Anti-electroshock degree

Class I equipment with internal power supply

Anti-electroshock degree

TEMP/SpO2/NIBP:

ECG/RESP:

BF

CF

Explosion proof level

Ordinary equipment，without explosion proof

Harmful liquid proof degree

Ordinary equipment，without liquid proof

Working system

Continuous running equipment

2.applicable standards

Medical electrical equipment GB 9706.1-2007,Part I:General requirements for safety

GB 9706.25-2005 Medical electrical equipment,Part 2-27:ECG monitoring equipment safety requirements

YY 1079-2008 ECG

YY0667-2008 Medical electrical equipment Part 2:Automatic cycling non-invasive blood pressure monitoring equipment,safety and essential performance.

YY0668-2008 Medical electrical equipment Part 2:multi-parameter patient monitoring equipment requirements for the safety.

3.monitor size and weight

size:300 ×275 ×150 mm  

Weight:4 kg

4.Power Supply:100~240 VAC,50/60 Hz,Pmax=90VA Fuse T1.5A

5.Battery

2.6 Ah 12V rechargeable battery

Operating time after full charge is more than 1 hours

Operating time after the first alarm of low battery will be about 5 minutes

Maximum charging time is less than 6 hours.

6 Signal Interface：Network interface  standard RJ45 Socket

7 Storage

Trend:720 hours

NIBP review:1000 NIBP events

Wave review:2 hours

Alarm review:200 alarm events

All storage data are non volatile.

8 Environment

8.1 Temperature

Working:0~40 °C

Storage:-20~50°C

8.2 Humidity

Working:15%-90 % (no coagulation)

Storage:15%-90 % (no coagulation)

8.3 Atmospheric pressure

Working 86.0 kPa~106.0kPa;

Storage 86.0 kPa~106.0kPa

9 ECG Specification

9.1 Heart rate calculation method

Since the first occurrence of heart rate to heart rate occurred in the second interval T1;second heart rate,heart rate occurred to a third place time interval T2;continuous record 10 times,and then calculated the average interval of 10,must the heart rate per minute.3s~10s refresh every heart.

9.2 Heart rate meter accuracy and arrhythmia response

Monitor the 20s stable time after figure ECG heart rate a wave group):heart rate display 40bpm±5bpm;b):heart rate display 30bpm±5bpm;c):heart rate display 120bpm±5bpm;d):heart rate display 45bpm±5bpm

A) Couple rhythm—two waves of duration is 1500ms;if the calculation all the QRS complex,heart rate to 80bpm,if only large R wave or S-wave,the heart rate to 40bpm.

B) Slow change couple rhythm—if the calculation all the QRS complex,heart rate to calculate 60bpm,if only large waves,heart rate to 30bpm.

C) Fast couple rhythm—if the calculation all the QRS complex,heart rate as 120bpm.

D) bi-directional contraction—if you calculate the QRS complex,heart rate to calculate 90bpm,if only large waves,heart rate to 45bpm.

9.3 Lead mode

5 Leads:RA、LA、LL、RL、V;lead mode:I,II,III,AVR,AVL,AVF,V

9.4 Gain

Gain control:manually four stalls

1/4 stalls(×0.25) 2.5mm/mV;1/2 stalls (×0.50) 5.0mm/mV; 1 stall (×1) 10mm/mV;2 stalls (×2) mV 20mm/mv;

9.5 Heart rate

Measure range:

Adult:15~300 bpm

Neonatal/Pediatric:15~350 bpm

accuracy:±1%

resolution:1 bpm

9.6 Sensitivity

>200 μV P-P

9.7 Differential Input Impedance

>5 M ohm

9.8 Bandwidth

Surgery:1~20 Hz

Monitor:0.5~40 Hz

Diagnostic;0.05~130 Hz

9.9 CMRR

Diagnostic Mode >90 dB

Monitor Mode:>110 dB

Surgery Mode:>110 dB

9.10 Electrode offset potential:±300mV

9.11 Input dynamic range

In any lead,the applied DC bias voltage of±300mV to 320mV/s rate of change of±5mV of the differential mode voltage,and display devices should have the capacity to respond;output signal amplitude error should not exceed±10% ;

9.12 pacing pulse suppression 

Monitor switch is open in the pacemaker,can inhibit the range:±2 mV~±700mV,width:0.1ms~2ms,rise time:10us~100μs normal QRS wave single pulse without overshoot pacing pulse does not affect heart rate calculation.

Monitor switch is open in the pacemaker,can inhibit the range:±2 mV~±5mV,width:0.5ms~2ms,rise time:10us~100μs single pulse overshoot normal QRS waves of pacing pulses,without affecting heart rate calculation.

Overshoot (a0) range should 0.025ap to 0.25ap range,independent of the choice of time constant,but not more than 2mV;

Monitor switch is open in the pacemaker,pacing pulse detector inhibition of rapid ECG signal to 1V/s RTI minimum input slew rate.

9.13 QRS wave amplitude and period range between 

Amplitude (p-v RTI) range:0.5mV~5mV;

Width (adult monitor):70~120ms;

Width (neonatal/pediatric):40~120ms;

Set monitor mode for adults should not be less than or equal to 0.15mV amplitude QRS signal or of less than or equal to 10ms between the 1mV signal a response.For neonatal/pediatric mode,monitors allowed to respond to the above two signals to respond to either or both;

9.14 frequency voltage tolerance 

Superimposed on a QRS wave signals received,and to meet tolerances of±10% of heart rate showed the error limits of accuracy required under the premise of the maximum frequency sine wave peak-valley kurtosis should not be less than 100μV (pv) 

9.15 drift tolerance 

When a 0.1Hz,amplitude 4mV (pv) of the triangular wave superimposed on a string of rate of 0.5mV,interval 100ms,repetition rate of 80bpm when the QRS wave,ECG heart rate monitor shows the error should be within 80bpm±8bpm;

9.16 baseline control and stability 

Reset:reset recovery time is not greater than the 3s;

Baseline Stability:After boot,10s baseline drift in the output rate should not exceed 10μV/s RTI;

After boot,1h,total drift should not exceed 500μV/s RTI;

Working temperature should not exceed 50μV/℃ 

9.17 system noise 

Should be not more than 30μV (p-v RTI) 

9.18 Multi-channel crosstalk 

Should not be imposed by the channel signal is not imposed without the signal channel output generated more than spin plus signal (multiplied by the gain) 5%;

9.19 Electro surgery interference suppression 

Heart rate should not exceed the interference is not activated when the heart rate±10%,interfere with the duration should not exceed 10S;

9.20 pacemaker pulse display capabilities 

Show an increase is not less than 0.2mV RTI;in 10s,the baseline drift is not greater than 10mm;

9.21 heart rate response time 

Step increase in heart rate from 80bpm to 120bpm maximum response time of less than 10 s;

Heart rate from 80bpm to 40bpm step to reduce the maximum response time of less than 10 s;

9.22 to the alarm time 

High heart rate alarm start time is less than 10 s by YY 1079-2008;

Low heart rate alarm start time is less than 10 s according to YY 1079-2008;

Cardiac stop alarm start time is less than 10 s by YY 1079-2008;

Tachycardia alarm start time is less than 10 s.

9.23 calibration signal 

1mV (peak to peak),the accuracy  ≤±5%

10 NIBP Specifications

10.1 Measurements

Pulse wave oscillation

10.2 Mode

Manual/Automatic/Continuous

10.3 Automatic measurement mode of measurement interval

1 minute,2 minutes,3 minutes,4 minutes,5 minutes,10 minutes,15 minutes,30 minutes,60 minutes,90 minutes,2 hours,3 hours,4 hours,8 hours

10.4 Continuous measurement mode of measurement time

5 minutes

10.5 pulse rate range

40-240 bpm

10.6 Measurement range and accuracy

Range

40~280mmHg systolic blood pressure for adults

Diastolic blood pressure 10~220mmHg

The average pressure of 20~240mmHg

40~220mmHg systolic blood pressure of children

Diastolic blood pressure 10~160mmHg

20~170mmHg mean pressure

Newborn systolic blood pressure 40~135mmHg

Diastolic blood pressure 10~100mmHg

The average pressure of 20~110mmHg

Static pressure range 0~300mmHg

3mmHg static pressure±Accuracy 

5mmHg;±Blood pressure accuracy:the maximum average error of 

Maximum standard deviation 8mmHg

10.7 overvoltage protection

Adult model 300 mmHg

Child model 240 mmHg

Neonatal model 150 mmHg

11 SpO ± Specifications

11.1 oxygen saturation

Measuring range 0 to 100%

Resolution 1%

2%±Accuracy of 70~100%:

<69%:not defined

11.2:pulse rate

Range 20~250bpm

Resolution 1bpm

3bpm±Accuracy 

12:temperature specifications

Sensor type 10K series,2.25K Series

Number of channels 2 channels

C°Range 0~50 

C°Resolution of 0.1 

C°(sensor error not included) 0.1° Accuracy 

13 recorder (optional)

Record width of 48 mm

Walking paper speed 25/50 mm/s

2-channel waveform tracings

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