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ENGLISH
If necessary, please visit our official website to get the information about SpO
2
probe that can be
used with this device.
If the device or component is intended for single-use, then the repeated use of these parts will pose
risks on the parameters and technical parameters of the equipment known to the manufacturer.
If necessary, our company can provide some information (such as circuit diagrams, component lists,
illustrations, etc.), so that the qualified technical personnel of the user can repair the device compo-
nents designated by our company.
The measured results will be influenced by the external colouring agent (such as nail polish, colour-
ing agent or color skin care products, etc.), so don’t use them on the test site.
As to the fingers which are too cold or too thin or whose fingernail is too long, it may affect the meas-
ured results, so please insert the thicker finger such as thumb or middle finger deeply enough into
the probe when measuring.
The finger should be placed correctly(see Attached figure 4), as improper installation or improper
contact position for sensor will influence the measurement.
The light between the photoelectric receiving tube and the light-emitting tube of the device must
pass through the subject’s arteriole. Make sure the optical path is free from any optical obstacles like
rubberized fabric, to avoid inaccurate results.
Excessive ambient light may affect the measured results, such as surgical light (especially xenon
light sources), bilirubin lamp, fluorescent lamp, infrared heater and direct sunlight, etc. In order to
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 SpO
2
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 defibrillation and in a short period after defibrillation,
as it has not defibrillation 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.
The computer intended to be connected with this device,shall be approved and certificated according
to IEC 60950.
After the mains is interrupted, the device will automatically switch to battery for working, it will auto-
matically switch to mains after it is restored.
1.4.2 Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow 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 SpO
2
waveform (PLETH) will decrease. In this case, the
measurement will be more sensitive to interference.
B. The measurement will be influenced 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:
a. The person who is allergic to silicone, PVC, TPU TPE or ABS can not use this device.
b. The damaged skin tissue can’t be measured.
c. During cardiopulmonary resuscitation.
d. When the patient is too hypovolemic.
e. For assessing the adequacy of ventilatory support.
f. For detecting worsening lung function in patients on a high concentration of oxygen.
