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9 SPECIFICATION
ENGLISH
Product code
Lot number
Note: Your device may not contain all the following symbols.
SpO2 [see note 1]
Display range 0% ~ 99%
Measured range 0% ~ 100%
Accuracy [see note 2] 70%~100%: ±2%;
0%~69%: unspecied.
Resolution 1%
PR
Display range 30 bpm ~ 250 bpm
Measured range 30 bpm ~ 250 bpm
Accuracy ±2 bpm or ±2%, whichever is greater.
Resolution 1 bpm
Accuracy under low perfusion [see note 3] Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
Light interference Under normal and ambient light conditions, the
SpO2 deviation ≤ 1%
Pulse intensity Continuous bar graph display, the higher display
indicates the stronger pulse.
Upper and lower limit of measured values
SpO2 0% ~ 100%
PR 0 bpm ~ 254 bpm
Optical sensor [see note 4]
Red light Wavelength: about 660 nm, optical output pow-
er: < 6.65 mW
Infrared light Wavelength: about 905 nm, optical output pow-
er: < 6.75 mW
Memory Up to 99 group of data under auto mode, total
duration does not exceed 72 hours.
Up to 24-hour data under manual mode.
Safety class Internally powered equipment, type BF applied
part
International Protection IP22
Working voltage DC 2.6 V ~ 3.6V
Working current ≤ 100 mA
Power supply Dry battery (2AA)
Dimension and Weight
Dimensions 110(L) × 60(W) × 24(H) mm
Weight About 120g (with Dry battery(2AA))
Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range. By articial inducing,
get the stable oxygen level to the range of 70 % to 100 % SpO2, compare the SpO2 values collected by the secondary standard pulse
oximeter equipment and the tested equipment at the same time, to form paired data, which are used for the accuracy analysis.(It is
applicable for the probes equipped
There are 12 healthy volunteers (male: 6. female: 6; age: 21~29; skin color: black: 4, light: 7, white: 1) data in the clinical report.
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