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prevent interference from ambient light, make sure to place the sensor properly and cover the sensor
with opaque material.
Frequent movement (active or passive) of the subject or severe activity can affect the measured
accuracy.
The SpO2 probe should not be placed on a limb with the blood pressure cuff, arterial ductus or intra-
luminal tube.
The measured value may be inaccurate during debrillation and in a short period after debrillation,
as it has not debrillation function.
The device has been calibrated before leaving factory.
The device is calibrated to display functional oxygen saturation.
The equipment connected with the Oximeter interface should comply with the requirements of IEC
60601-1.
1.4.2 Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood ow of subject is
required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding,
or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the
measurement will be more sensitive to interference.
B. The measurement will be inuenced by intravascular staining agents (such as indocyanine green or
methylene blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or dysfunctional he-
moglobin(such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb) and sulfhaemoglobin
(SuHb)), but the tester may appear hypoxia, it is recommended to perform further assessment ac-
cording the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe anemia
patients still show better pulse oxygen measured valued.
E. Contraindication: no
2 PRINCIPLE
Figure 1 Operating principle
Principle of the Oximeter is as follows: An experience formula of data process is established taking use
of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb)
and Oxyhemoglobin (HbO2) in glow & near-infrared zones. Operation principle of the device is: Photo-
electric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning
& Recording Technology, so that two beams of different wavelength of lights can be focused onto human
nail tip through perspective clamp nger-type sensor. Then measured signal can be obtained by a pho-
tosensitive element, information acquired through which will be shown on screen through treatment in
electronic circuits and microprocessor.
3 FUNCTIONS
3.1. Main performance
A. SpO2 value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator appears before working abnormally which is due to
ENGLISH
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
5


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