Pulse oximeter monitoring is used for more than 20 years in the emergency rescue. It is known as the "Fifth Vital Signs" in the emergency room. The Pulse oximeter monitoring is essential, as during process of cardiopulmonary resuscitation and tracheal intubation, hypoxemia and bradycardia often can not be found in time. And a Cross-Sectional Study showed that when the used of pulse oximeter monitor in the emergency department, the rate of recue is decrease from 0.34% to 0.12%, the rate of ICU transfer decrease from 0.56% to 0.29%.
Suitable for adult, pediatric and neonate patients
Technical Specification |
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Enclosure | |||||
Weight | 258grams (9.1 ounces) with batteries | ||||
Dimensions | 13.5cm × 7.5cm × 2.8cm | ||||
Alarms | |||||
Categories | Patient status and system status | ||||
Notification | Audible and visual | ||||
Setting | Full storage, low battery and sensor off | ||||
Range | Pulse rate (30-350bpm), SpO2 (0-100%) | ||||
Alarm volume level | 0-85dB | ||||
Range, Accuracy and Resolution | |||||
Range Type | Range Values | ||||
Measurement Ranges | |||||
SpO2 | 0-100% | ||||
Pulse rate | 30-350bpm | ||||
Measurement Accuracy | |||||
SpO2 | 70-100% (±2%), <70% undefined | ||||
Pulse rate | ±2bpm/±2% take maximum | ||||
Resolution | |||||
SpO2 | 1% | ||||
Pulse rate | 1bpm | ||||
Electrical | |||||
AC power requirement | 100-240VA, 47-63Hz | ||||
Power comsumption | 20VA | ||||
Batteries | |||||
Types | Alkaline/Ni-Mh Batteries, IEC: LR6 | ||||
Operating time | ≥20hours | ||||
Charge time | ≤ 6hours | ||||
Environment | |||||
Operating tempearture | 0-45℃ | ||||
Storage temperature | -20-60℃ | ||||
Operating humidity | 30-95% | ||||
Operating altitude | -500-5000m | ||||
Trends | |||||
Types | Tabular | ||||
Memory | Save total 120 hours data events. Save data and time, alarm conditions, pulse rate and SpO2 measurements | ||||
Standards and Certification | |||||
IEC 62366 | Medical devices-Application of usability engineering to medical devices | ||||
IEC 62304 | Medical device-software life cycle processes | ||||
MDD 93/42/EEC | European Medical Device Directive | ||||
ISO 13485 | Medical equipment-Quality management system | ||||
EN ISO 14971 | Medical devices-Risk management | ||||
EN 60601-1 | Medical electrical equipment | ||||
EN 60601-2 | Medical electrical equipment | ||||
EN 60601-8 | Medical electrical equipment | ||||
EN 980 | Symbols for use in labeling of medical devices | ||||
EN 1041 | Information supplied by the manufacture of medical devices | ||||
ISO 80601-2-61 | Medical electrical equipment-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use | ||||
EN ISO 10993-1 | Biological evaluation of medical devices | ||||
EN ISO 10993-5 | Biological evaluation of medical devices | ||||
EN ISO 10993-10 | Biological evaluation of medical devices | ||||
ISO 14155-1 | Clinical investigation of medical devices | ||||
CE | CONFORMITE EUROPEENNE | ||||
SFDA | State Food and Drug Administration |
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Magill, SA 5072
Australia
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Tel: 08 7073 9324
Email: info@utechmd.com.au