OEM Module

advertisement
Currently, a large percentage of Meditech business is performed
for the healthcare market – assembling everything from patient
heart monitors to cancer diagnostic devices. We thoroughly
understand the critical nature of the medical industry, and provide
thorough documentation with traceability to all of our medical
customers, ensuring the medical PCB assembly will exceed
manufacturing requirements and customer satisfaction demands.
Medical PCB Assembly Due to our continued growth in the medical
and bio-medical markets, Meditech has invested in certifications
that are necessary for circuit board assembly manufacturing. We
are ISO13485:2003 certified and compliant to FDA CRF820 part 21,
guaranteeing that we meet the necessary requirements for medical
PCB assembly.
Our software management system, Cogiscan’s Track, Trace and
Control (TTC) System, that is used in our production floor is
incredibly beneficial to our medical PCB assembly customers. This
system allows us to provide detailed traceability, all the way to the
reference designator, on enrolled products. Additionally, the TTC
Program further illustrates our commitment to transparency and
our emphasis on full traceability.
We would genuinely love the opportunity to assist in building your
medical product – please contact us to learn more about our
healthcare services.
We offer world-class circuit board assembly and
electro-mechanical box build services to the medical
industry.
Products Range
Digital SpO2 Module
www.meditech.com.cn
oem@meditech.cn
Analog SpO2 Module
Multi Parameter Monitor
NIBP Module
Side stream EtCO2 module
Digital SpO2 Module
Analog SpO2 Module
Model: MD100
Model: MD200
Range
Pulse rate: 30 ~ 250 bpm
SpO2: 0 ~ 100%
Weak perfusion 0.1%
Resolution(1SD)
Pulse rate: (30~250BPM)
+2bpm or -2bpm Normal
+3bpm or -3bpm Motion or low perfusion
SpO2: (70~100%)
+2% or -2% Normal
+3% or -3%Motion or low perfusion
Below 70% Not specified
Environmental Requirements
Operating temperature: 0~45 °C
Storage temperature: -20~60 °C
Operating Humidity:30~95%
Storage Humidity:10~100%
Operating Altitude:-500~5000m
Storage Altitude:-500~10000m
Par.
Min.
Typ.
Max.
5V
+4.75V
+5V
+5.25V
Ripple
---
---
100mVp-p
Current
---
20mA
---
Serial transmission logic capacity:
TTL/RS232 Serial Port
Standards
IEC60601-1: SPO2: BF-type
IEC60601-1-27: 1994: EN865
ANSI/AAMI SP10: 1992: EN12470-4:2001
Sensor : Only digital sensor can be used for this module
SPO2
Measuring range: 50 -100% SPO2
Measurement accuracy: ±2 @ 50-100% SPO2
Less than 50% have not been defined
Pulse rate
Measuring range : 30-235 times / min
Measurement accuracy: Greater than ±2 times / min or ±2%
Bar chart: 0-8
Environmental Requirements
Operating temperature: 0~45 °C
Storage temperature: -20~60 °C
Operating Humidity:30~95%
Storage Humidity:10~100%
Operating Altitude:-500~5000m
Storage Altitude:-500~10000m
Serial transmission logic capacity: TTL/RS232 Serial Port
Security
Oxygen saturation: BF – type
Power Requirements
Operating voltage: 5V ±0.1V DC
Power: 40mA
Environmental conditions
Operating temperature: 5-50℃
Storage temperature : -20℃ - +70 ℃
Relative humidity : 0-85% (non-condensing)
Size
40 x 52 x 10mm
Standards
IEC60601-1: SPO2: BF-type
IEC60601-1-27: 1994: EN865
ANSI/AAMI SP10: 1992: EN12470-4:2001
Sensor: BCI sensor can be used for this module.
Multi Parameter Module
Model: MD01
HR
Adult
15 ~ 300 BPM
Neo/Ped
15 ~ 350 BPM
Accuracy ± 1% or ± 1bpm choose the greater one
Resolution 1BPM
RESP rate Range and Accuracy
Adult
7~120BrPM
Neo/Ped
~150 BrPM
Resolution 1 BrPM
Accuracy ±2 BrPM
NIBP
Adult Mode
SYS 40 ~ 270mmHg
DIA 10 ~ 215 mmHg
MEAN 20 ~ 235 mmHg
Pediatric Mode
SYS 40 ~ 200 mmHg
DIA 10 ~ 150 mmHg
MEAN 20 ~ 165 mmHg
Neonatal Mode
SYS 40 ~ 135 mmHg
DIA 10 ~ 100 mmHg
MEAN 20 ~ 235 mmHg
stalic state pressure range 0~300mmHg
Stalic state pressure accuracy ±3mmHg
blood pressure accuracy: Maximum Mean error ±5mmHg;
Maximum Standard deviation
±8mmHg
SPO2
Range
0 ~ 100 %
Resolution 1 %
Accuracy 70~100%:±2 DIGIT
0% ~ 69% unspecified
Pulse Rate
Range
20~300bpm
Resolution 1BPM
Accuracy ±3bpm
TEMP
Range
0 ~ 50 °C
Resolution 0.1°C
Accuracy ±0.1°C(not include sensor error)
IBP Accuracy: ± 1mmHg or ± 2%,take the greater one (not
include sensor error)
Power supply:
Request of exterior power supply input voltage 12V
DC(±10%),0.5A,lines wave <100mv
Power consume:stalic state < 2W,work < 6W.
Isolated: 4000VAC Leak current <0.5mA
Work Environment
Operating temperature: 0 ~ 55°C
Storage temperature:
-20 ~ 65 °C
Operating Humidity: 15% ~ 95 % (no coagulate)
Storage Humidity:
10% ~ 95 %(no coagulate)
Size: 120mm x 100mm x 25mm
Weight: < 300 g(not include accessories
NIBP Module
Model: MD-IBP2
Measuring range:
Adult:
30 to 255 mmHg systolic blood
pressure
An average of 20 to 235 mmHg
pressure
15 to 220 mmHg diastolic blood
pressure
Pulse rate of 30 to 240 times /
min
Newborn:
30 to 135 mmHg systolic blood
pressure
An average of 20 to 125 mmHg
pressure
15 to 110 mmHg diastolic blood
pressure
Pulse Rate of 40 to 240 times /
min
Measurement time:
Adults: up to more than 120
seconds;
Newborn: up to more than 90
seconds;
Restriction on software
over voltage:
Adult: Less than 290mmHg;
Newborns: no more than
145mmHg;
Protection on hardware
over voltage:
Adult: 300 ±10 mmHg;
Newborn: 150 ±4 mmHg;
Measuring principle
Oscillometry
Deflation approach:
ladder Deflated
The initial inflation
pressure value:
Adult: 150 mmHg;
Newborn: 70 mmHg;
Sensor zero reset:
Prior to each measurement
Resolution:
1 mmHg
Measurement accuracy:
Maximum average deviation: no
more than ± 5 mmHg;
maximum standard deviation:
less than 8 mmHg;
Pressure accuracy
instructions:
± 3 mmHg
Leakage:
less than 6 mmHg Per minute;
Electrical performance:
Voltage: 12 VDC (adapt to the
corresponding valve), 5 VDC
Quiescent current: 80 mA
Measurement current: 200 mA
Environment:
inflated current: 600mA
Operating Temperature: 0 to 55
Celsius degrees
Storage Temperature: -20 to 65
Celsius degrees
Humidity Range: 0 to 95%, noncondenser
Operation Altitude: -500 m to
4600 meters
Life Span: can operate 100,000
blood pressure measurements
Size
12.6 cm x 6.8 cm x 2.8 cm
Weight:
180 g
Mainstream EtCO2 Module
Model: MD-ET2
Sensor Operating Principle
Energy Emitting Device
Energy Detecting Device
CO2 Range
CO2 Accuracy
Intelligent design can wipe off the excursion from
temperature, pressure and inconsistent component.
It allows wrong power supply, humidity in the pipeline.
Great capacity to ensure that any provision of about 50 sets
of stock
TTL or RS232 can be choice by customer.
Breath Rate
Dimensions
Weight
Operating Temperature
Range
Shipping / Storage
Temperature Range
Automatic Offset
Calibration
Input Voltage
Interface
Pneumatics
Power Consumption
Warm-up Time
Response Time: Detector
System
Infrared Spectroscopy
Proprietary High Efficiency IR
Source
Frequency Stable Thermopile
0% to 20%
± 2 mmHg @ < 5.0% CO2 (at
BTPS)
< 5% of reading @ 5.0% to 13%
CO2 (at BTPS)
< 10% of reading @ 13% to
20.0% CO2 (at BTPS)
2-150 BPM
77mm*52mm*28mm
< 3.0 ounces (< 76 grams)
5° C to 50° C
-40° C to 70° C
Time and temperature based, as
well as on-demand
5.00 Volts (± 5%)
Highly configurable serial digital
interface(TTL/RS232), CO2 and
barometric waveform data,
Breath Detect Algorithm data
On-board aspiration pump and
flow controller
Configurable aspiration flows to
250 ml/min (± 10%)
480mW (typical with pump on)
1200mW (extreme status)
10 seconds
28 mSec (typical)
200mSec (typical) (Dependent
Upon Implementation,
Pneumatics and Water
Separation Technique)
Download