Battery Installation
1.Thread thinner end of the lanyard through the hanging hole.
2.Thread thicker end of the lanyard through the threaded end
before pulling it tightly.
3.Install as the figures show. (See Figure )
Lanyard Installation
1.Pull the battery cover horizontally.
2.Put two AAA batteries into battery cassette in right polarities and push the
cover back.
Notes: Battery polarities must be correct. Otherwise, damage might occur to device.
Please put or remove batteries in right order, or it will damage the device bracket.
Please remove the battery if the oximeter is not used for long time.
3.Install as the figures show. (See Figure)
Remove the battery from the product if it is not required for extended
Product Operation Steps
1.Install two AAA batteries into battery cassette before closing the cover.
2.Nip the clamp as diagram to the largest.(See Figure )
3.Plug one finger into rubber hole of the Oximeter (it is best to plug the finger
thoroughly) before releasing the clamp.
4.Do not tremble while the oximeter is working. It's better that the whole body be
in still status.
Note: For normal use after long interruptions, refer to the product operation steps.
5.Read corresponding data from display screen.
7
8
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
Product Operation Scope
The YUWELL
®
Finger Pulse Oximeter is designed for fingers(not thumb) between 0.3 and 0.9
inch (0.8-2.3cm) thick. And the finger shall be inserted into the sensor position which is in the
middle of the device.
The Finger Pulse Oximeter is NOT design for newborns and infants.
Product Properties
1.Operation of the product is simple and convenient.
2.The product is small in size, light in weight and portable.
3.The product can operate continuously for 17 hours with two brand new AAA batteries. (The operation
time may vary due to the different performance of batteries)
4.Low voltage prompt will appear on the display when the battery voltage is lower than the minimum
value of normal working voltage range.
5.The product will automatically shut down when there is no signal detected for about eight seconds.
periods of time in order to avoid damage to the oximeter resulting from a leaking battery.
Do not use the new batteries with the old ones. Alkaline battery of long service is recommended,
and do not use rechargeable batteries.
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