Product Specification

Payment Terms	L/C, T/T, Western Union, MoneyGram	Supply Ability	10000units/year
Delivery Time	Within 3 days	Packaging Details	carton box
size	15 inch	MOQ	1
OEM	yes	color	black
Brand Name	RAINBOW	Model Number	PM-9000GTE
Certification	ISO13485,FSC	Place of Origin	Hunan,China
High Light	7 In 1 Multipara Patient Monitor ，Low Power Multipara Patient Monitor ，Touch Screen ICU Vital Signs Monitor

Touch Screen Vital Sign Light Weight Human Voice Multi Parameter PM-9000GTE Patient Monitor

 

Product brief

1.ARM9 main board + 7in1 monitor module; Based on embedded linux, the monitor have small size, high integration, low power and high performance

2.Parameters include ECG, Respiration, NIBP, dual temperature,SpO2, pulse rate, dual IBP, CO₂ and 3.Multi-Gas

4.Unique human voice alarm

5.Full digital SpO2 technology with excellent performance in low perfusion and movement

6.ECG monitoring include arrhythmia analysis, ST calculation and Pace analysis

7.Protected against defibrillation, ESU and myoelectric artifact

8.NIBP have dual over pressure protect, can operation correctly under severe environment to protect the patient

9.Full alarm feature include 3 alarm level, alarm sound, alarm light and on screen alarm message

10.Human voice alarm helps the user to identify the source of alarms

11.Embedded network can connect to central monitor server

12.Maximum 720 hours trend review, 1000 NIBP review, 2 hours full wave review and 200 alarm event review

13.USB port support USB disk data output and PRS software to review patient data

14.USB WIFI module support wireless central monitor

15.15’high resolution LCD, big font screen provided

16.Optional touch screen for better user interface

 

Specification

Warning

The patient monitor may not meet its performance specification if stored or used outside the manufacturer’s specified temperature and humidity range.

1.1 Classification

Anti-electroshock type Class I equipment

Anti-electroshock degree CF defibrillation

1.2 Accordant Standard

Medical Device Directive 93/42/EEC
EN60601-1:2005 or IEC60601-1:2005	Medical Electrical Equipment, Part 1: General Requirements for Safety
EN60601-1-1 or IEC60601-1-1	Medical Electrical Equipment, Part 1-1: General Requirements for Safety, Collateral Standard: Safety Requirements for Medical Electrical Systems
IEC60601-1-4	Medical Electrical Equipment, Part 1-4: General Requirements for Safety, Collateral Standard: Programmable Electrical Medical Systems
IEC60601-2-49	Medical Electrical Equipment, Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment
IEC 60601-1-2:2007	Electromagnetic Compatibility, Medical Electrical Equipment
ISO 21647:2009	Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors

1.3 Power Supply

100~240 VAC, 50/60 Hz, Pmax=60VA

1.4 Battery

2200 mAh 14.8V rechargeable Lithium battery

Operating time after full charge is more than 1.5 hours

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

Maximum charging time is less than 6 hours.

1.5 Environment

Temperature

Working 0 ~ 40 °C, 5 ~ 40 °C with CO₂

Storage -20 ~ 50°C

Humidity

Working 15% - 90 %

Storage 15% - 90 % (no coagulation)

1.6 Signal Interface

Network interface standard RJ45 Socket

USB port

1.7 ECG

1.7.1 Lead mode

5 Leads, I, II, III, AVR, AVL, AVF, V

1.7.2 Gain

´2.5mm/mV, 5.0mm/mV, 10mm/mV, 20mm/mV

1.7.3 Heart rate

Measure range:

Adult 15 ~ 300 bpm

Neonatal/Pediatric 15 ~ 350 bpm

accuracy ± 1%

resolution 1 bpm

1.7.4 Sensitivity

> 200 μV P-P

1.7.5 Differential Input Impedance

> 5 M ohm

1.7.6 CMRR

Diagnostic Mode >90 dB

Monitor Mode >110 dB

Surgery Mode >110 dB

1.7.7 Electrode offset potential

±300mV

1.7.8 Leakage Current

< 10 μA

1.7.9 PACE pulse detect

range ±2～±700mV

width 0.1～2ms

rise time 10～100µs

1.7.10 PACE pulse rejection

range ±2～±700mV

width 0.1～2ms

rise time 10～100µs

1.7.11 Baseline Recovery

< 3 s After defibrillation.

1.7.12 Signal Range

± 5 mV p-p

1.7.13 Bandwidth

Surgery 1 ~ 20 Hz

Monitor 0.5 ~ 40 Hz

Diagnostic 0.05 ~ 130 Hz

1.7.14 Calibration Signal

1 mV p-p, ± 5% accuracy

1.7.15 ST measurement

range -2.0 ~ +2.0 mV

Accuracy -0.8mV～+0.8mV: ±0.02mV or ±10%, which is greater

Other range: unspecified

1.8 Respiration

1.8.1 Method

Impedance between RA-LL or RA-LA

1.8.2 Differential Input Impedance

>2.5 M ohm

1.8.3 Respiration Impedance Range

0.3~3Ω

1.8.4 Base Impedance Range

200Ω-2000Ω

1.8.5 Bandwidth

0.3 ~ 2 Hz

1.8.6 Gain

´0.25,´0.500,´1,´2,´4

1.8.7 Respiration Rate

Measurement Range

Adult 0 ~ 120 BrPM

Neonatal / Pediatric 0 ~ 150 BrPM

Resolution 1 BrPM

Accuracy 0～6 BrPM: unspecified

7～150 BrPM: ±2 BrPM or ±2%, use the greater

Inspiriting current < 300 µA RMS max

1.8.8 Apnea Alarm

10 ~ 40 s

1.9 NIBP

1.9.1 Method

Oscillometry

1.9.2 Measure mode

Manual, Auto, STAT

1.9.3 Measure Interval in AUTO Mode

1,2,3,4,5,10,15,30,60,90,120,180,240,480 min

1.9.4 Measure Period in STAT Mode

5 min

1.9.5 Pulse Rate Range

40 ~ 240 bpm

1.1.1 Measure and Alarm Range

Adult Mode

SYS 40 ~ 280 mmHg

DIA 10 ~ 220 mmHg

MEAN 20 ~ 240 mmHg

Pediatric Mode

SYS 40 ~ 220 mmHg

DIA 10 ~ 160 mmHg

MEAN 20 ~ 170 mmHg

Neonatal Mode

SYS 35 ~ 135 mmHg

DIA 10 ~ 100 mmHg

MEAN 20 ~ 110 mmHg

1.1.2 Static pressure accuracy

±3mmHg

1.1.3 Resolution

1mmHg

1.1.4 Accuracy

Maximum Mean error ±5mmHg

Maximum Standard deviation 8mmHg

1.1.5 Overpressure Protection

Adult 300 mmHg

Pediatric 240 mmHg

Neonatal 150 mmHg

1.1 SpO₂

1.1.1 Measurement Range

0 ~ 100 %

1.1.2 Resolution

1 %

1.1.3 Accuracy

70% ~ 100% ±2 %

0% ~ 69% unspecified

1.1.4 Pulse Rate

Measure and Alarm Range 20~250bpm

Resolution 1bpm

Accuracy ±3bpm

1.2 Temperature

Channel 2

Measure and Alarm Range 0 ~ 50 °C

Resolution 0.1°C

Accuracy(no sensor) ± 0.1℃(25℃ – 45℃) ,± 0.2℃(other)

Accuracy(include sensor) ± 0.2℃(32℃ - 42℃)

± 0.3℃(other)

1.3 MASIMO Spo2 (optional)

Measurement range 1 to 100%

Resolution 1%

Accuracy 70 to 100%: ±2% (measured without motion in adult/pediatricmode)

70 to 100%: ±3% (measured with motion in neonate mode)

70 to 100%: ±3% (measured with motion)

0% to 69%: Not specified.

Refreshing rate 1 s

Updated period 8 s, 16 s

Pulse Rate

Measurement range 25 to 240 bpm

Resolution 1 bpm

Accuracy ±3 bpm (measured without motion)

±5 bpm (measured with motion)

Refreshing rate 1 s

Updated period 8 s, 16 s

Low Perfusion

Conditions Pulse amplitude: >0.02%

Light penetration: >5%

SpO2 accuracy ±2%

PR accuracy ±3 bpm

1.4 NELLCOR SpO₂(Optional)

1.4.1 SpO2

Range 0～100%

resolution 1%

accuracy 70～100%:±2%

< 69%:undefined

1.5 IBP(optional)

1.5.1 Sensor

reusable sensors:OHMEDA P23XL or BD,EDWARD compatible

once usage:OHMEDA DT-4812 or BD,EDWARD compatible

excitation voltage:＋5Vdc±2%

sensitivity:5uV/V/mmHg

1.5.2 Channels

2 channels

1.5.3 Measuer Range

-50~ 360(mmHg)

1.5.4 Resolution

1mmHg

1.5.5 Accuracy(no sensor)

±2% or ±1mmHg, use the greater

1.5.6 Band Width

Normal mode: DC～40Hz

Smooth mode: DC～12.5Hz

1.6 CO₂(optional)

1.6.1 Measuer Range

0% ~ 13%

1.6.2 Resolution

1 mmHg

1.6.3 Accuracy

±2 mmHg @ < 5.0% CO₂ (at ATPS)

1.6.4 Breath Rate

Breath Rate: 3 - 150 bpm

1.7 Gas (optional)

1.7.1 Measuer Range

CO2 0 - 15 %

N2O 0 - 100 %

HAL, ISO, ENF 0 - 8 %

SEV 0 - 10 %

DES 0 - 22 %

1.7.2 Accuracy

CO2 ± (0.2 %ABS + 2 %REL)

O2 ± (1 %ABS + 2 %REL)

N2O ± (2 %ABS + 2 %REL)

HAL, ISO, ENF ± (0.15 %ABS + 2 %REL)

SEV ± (0.15 %ABS + 2 %REL)

DES ± (0.15 %ABS + 2 %REL)

1.7.3 Breath Rate

Breath Rate: 0 - 150 bpm, ±1bpm

1.8 Touch Screen (optional)

1.8.1 Method

4 wire resistor

1.8.2 size

12.1 inch

1.9 Recorder(optional)

Paper width 48 mm

speed 25/50 mm/s

wave channel 3 channels