14
SpO
2
Standards
Meet standards of ISO 80601-2-61
Measurement accuracy verification: The SpO
2
accuracy has been verified in human
experiments by comparing with arterial blood sample reference measured with a CO-
oximeter. The pulse rate accuracy has been verified by ECG Signal Emulator. Pulse
oximeter measurement are statistically distributed and about two-thirds of the
measurements are expected to come within the specified accuracy range compared to
CO-oximeter measurements.
SpO
2
range
70% to 100%
SpO
2
Accuracy (Arms)
80-100%:
±
2%, 70-79%:
±
3%
PR range
30 to 250 bpm
PR accuracy
±
2 bpm or
±
2%
，
whichever is greater
Sleep Recording
Recording time
Up to 10 hours
Data storage
SpO
2
, pulse rate
Measurement summary
O2 score, Total duration, <90% STAT, Average
saturation, Lowest saturation, Summary(No abnormal
detected, blood oxygen drop detected, Unable to
analyze)
Pedometer
Range
0 to 99999 steps
Vibrator
Event
Steps, low oxygenation
Threshold
Oxygenation: 80% to 90%, adjustable
Steps: 0 to 99999, adjustable
Mobile APP
Operating system
IOS 9.0 or above, Android 4.0 or above
IOS Capability
iPhone 4s and models launched subsequently; iPad 3
and models launched subsequently;
Android Capability
Mobile phone or pad with
Bluetooth
2.1 or above
Functionality
Data export, data review, data sharing