
noninvasive passive spo2
- Description
Description
Product description:
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) |
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