noninvasive passive spo2
A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of hemoglobin oxygen saturation (SpO2).
SpO2 measurement range at least 70 to 99 %, minimum resolution 1%
Accuracy of SpO2 better than ± 2%
Pulse rate range at least 30 to 240 bpm, minimum gradation 1 bpm
Accuracy of pulse rate better than ± 4 bpm
Signal strength or quality to be visually displayed
Automatic power-off facility required after minimum of 1 minute
Low battery display required
Integrated display for data visualization with size not less than 5 inches.
Video display of at least the following parameters:
a) SpO2 sensor connected;
b) alarms disabled;
c) low battery;
d) Battery in charge.
At least the following audio alarms:
a) high frequency;
b) low frequency;
c) Low saturation.
Battery charger, Batteries
Oxymeter cable with a length of at least 1.2 m;
1 adult patient reusable oxymeter sensor
1 pediatric patient reusable oxymeter sensor;
1 neonatal patient reusable oxymeter sensor.
Risk classification: Class B (GHTF Rule 10);Class II (USA); Class II (EU, Japan, Canada and Australia)
Regulatory approvals: Should be FDA or CE approved product.
International Standard: ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes (Australia, Canada and EU)
ISO 14971:2007 Medical devices – Application of risk management to medical devices IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance