noninvasive passive spo2

A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of hemoglobin oxygen saturation (SpO2).

Technical characteristics:

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.

Accessories:

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)