5
6
8.Measurement accuracy- in the absence of movement:
Note:The accuracy(A
RMS
) is calculated by the measurement values after a statistical distribution；
compared to the reference device in a control study, approximately 2-thirds of the values were at(over
or below) the accuracy(A
RMS
) value.
Pulse rate: 25bpm～250bpm, accuracy(A
RMS
): ±1% or ±1bpm(larger)
9.Operation mode: Continuous operation.
�
65
70
75
80
85
90
95
100
0
15
30
45
60
75
90 105 120 135 150
Time�/s
Response
�
Time
8�
Beat
�
Average
SpO
2
/ %
Figure 4
10.Device response time.(See Figure 4)
11.Peak wavelengths and light output power：
Emission wavelength range 600nm-1000nm, radiation intensity is less than
15mW/sr (20mA).
Information of wavelength range may be of especial use to clinical doctors.
12.Description of the effect on displayed and transmitted SpO
2
and Pulse rate
data value：
1)data averaging and other signal processing.
2)the data update period:≤3 pulse rate cycles, less than 30s.
Note: Data processing and update will not affect pulse rate and SpO
2
.
13.The pulse waveform has been normalized, the measurement value is the best when the waveform is
smooth and stable.
14. Internally Powered ME Equipment
15.TYPE BF APPLIED PARTS
16.Degrees of protection provided by enclosures (IP code)：IP22.
Technical Description
1. Determination of Oxygen Saturation Accuracy
The claimed oxygen saturation is supported by coverage of the entire range of clinical research
measurements.
2.Data Collection
In the clinical test process, data points are recorded with comparable density in the entire claimed
range.
3. Data Analysis
For each claimed range, the oxygen saturation accuracy of the Pulse Oximeter should be represented
in the form of mean root square of the difference between the measured values of oxygen saturation
and the reference value. The formula is as follows:
A
rms
: accuracy.
n: test sample quantity.
SpO
2i
: measured value of pulse oxygen saturation during the first measurement using the finger pulse
Oximeter.
S
Ri
: reference value of pulse oxygen saturation during the ith measurement using the carbon-monox-
ide-blood-gas analyzer.
4. Characteristics of Population under Clinical Research
The group of healthy adult volunteers for the study consisted of 12 subjects - 4 women and 8 men, The
ages ranged from 18 to 50 years. The subject weights ranged from 48 to 90kg. The subject Height
ranged from 160 to 182cm. The Skin tones included in the study were as follows: 3 subjects with dark
Indication for Use
Intended use: The YUWELL
®
Finger Pulse Oximeter is a kind of non-invasive, non-sterile, reusable, spot
checking device which can measure and display SpO
2
and pulse rate through finger. It is intended for adults
and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continu-
ous monitoring, using during motion or using with low perfusion.
Contraindications: None.
Technical Parameters
1.Display Type: LED
SpO
2
Display range: 0%~100%.
Pulse Rate Display range: 25bpm~250bpm.
2.Power: Two AAA 1.5V alkaline batteries.
3.Working Current: Less than 40mA at rated voltage 3V.
4.Anti-interference ability of ambient light: Deviation in blood oxygen content is less than ± 1% when
measured under indoor nature light / existing lighting and measured in the dark room.
5.The product will automatically shut down when there is no signal detected for about eight seconds.
6.Dimension(YX102/YX103):60mm*38mm*35mm(LWH), Weight:38g approximately (without batteries).
7.Working Environments: Ambient temperature: 5℃～40℃; Relative humidity: ≤80％; Atmospheric
pressure: 860hPa～1060hPa.
Display
Symbol of oxygen saturation
Low Battery
Symbol of
pulse rate
Pulse bar
Pulse rate
Oxygen
saturation
Figure 2 Wave signal undetected
Figure 3
Signal undetected
Signal inadequacy
(eg: 1.Finger is out.
2.Device fault )
Range
90% to 100%
80% to 90%
70% to 80%
＜70%
A
RMS
±2%
No definition
pigmentation, 5 subject with very light pigmentation.
The remaining subjects with light (medium) skin
tones of Asian origins.
5.Graphical Plot of SaO
2
versus error (SpO
2
- SaO
2
)
6.The technology used in Finger Pulse Oximeter has
been verified with accuracy when there is no motion
via human blood studies on healthy volunteers of
both male and female with light to dark pigmented
skin in induced hypoxia studies in the range of
70%-100% SpO
2
against a laboratory co-oximeter.
7.The technology used in Finger Pulse Oximeter has
been verified with the pulse rate accuracy of
25-250bpm range in the bench top test against
SpO
2
ACCURACY (A
RMS
)
