| Customization: | Available |
|---|---|
| Classification: | Imaging Diagnostic Equipment |
| Type: | ECG |
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1.0 The usage range
This specification suited for customer's appointed models.
2.0 Ambient condition
2.1 Ambient temperature: +5-- +40
2.2 Relative humidity:below80%
2.3 Atmospheric pressure: 86Kpa-106KPa
2.4 Storage and transport method: individual moistureproof package. Transport conditions is under the 0--+45 temperature.
3.0 Construction
3.1 Appearance requests:
a) The cable is round and glossy. the color uniformity. the jacket
is ok. no Disrepair. no dirt. no disfigurement. etc.
b) The surface of the connector is glossy. no burr. no obvious machine scar. no disfigurement. no modification. no dirt. no metal rust etc.
c)Plugs.cable.connections between the sensors should be strong. reliable
3.2 Size requirements:
Testing the Size according to the drawing.
(The important size requirements. please notify it on time)
3.3 Packaging requirements:
The packaging in accordance with the requirements of the engineer drawing. (In case of special packaging requirements. please promptly notify it.)
4.0 Technical requirements
4.1Reference to ISO 9919:2005(E)Special requirements of pulse oximetry GB 9706.1-2007 Medical lectrical equipment - Part 1: General requirements for safety and essential performance
4.2 Use performance
4.2.1 SpO2 Test range and precision
4.2.1.1 SpO2 Test range: Should be 70% -100%
4.2.1.2 SpO2 Test precision:(90%-100%) 2%; (70%-89%)3%
4.2.2 Pulse Test range and precision
4.2.2.1Pulse Test range: Should be 30bpm -245bpm
4.2.2.2 Pulse Test precision: 3 bpm
4.3 Mechanical properties:
4.3.1Insertion and extraction force: 0.3-2 kgf.
4.3.3Vertical pull length:> 10kg. 1 minutes continuously and the jacket is ok.
(Plug side)
5.0 environmental protection requirements:
5.1All the raw materials should comply with ROHS standard
Principle of Operation:
Non-dispersive infrared (NDIR)
Initialization Time:
Capnogram displayed in less than 20 seconds
Reaching full specifications within 2 minutes.
Co2 Measure Range
0 - 150 mmHg
0 - 19.7%
0 - 20kPa
Co2 Measure Resolution
0.1mmHg
Co2 Accuracy:
0 -40 mmHg
41- 70 mmHg
71-100 mmHg
101-150 mmHg
Respiratory Rate:
Range 3 - 150 BPM
Accuracy ±1 breath
Calibration:
No routine user calibration required, The mainstream sensor an airway adapter , zero is required when changing to a different airway adapter
Compensation:
Barometer Pressure 450 - 850 mmHg.
Operator selectable O2 , N2O, He compensation.
Power Requirements:
5.0 VDC ±5%, power consumption less than 1.3W typical
Temperature / Humidity:
Operating: 0 ºC to 40 ºC, 10 to 90% RH
Storage: - 40ºC to 70 C, <90% RH
Data Interface:
Rs232, 19200 baud rate, standard N-8-1. Fully compatible with Respironics Co2 module's communication protocol
Regulatory:
Designed to comply YY0601 and ISO21647.
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