Clinical Restrictions - PULOX PO-100 Manual De Instrucciones

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 Pulse Oximeter should not be placed on a limb with the blood
pressure cuff, arterial ductus or intraluminal 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.

1.4.2 Clinical Restrictions

1. As the measure is taken on the basis of the arteriole pulse, a substantial
pulsating blood flow of the 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.
2. The measurement will be influenced by intravascular staining agents
(such as indocyanine green or methylene blue), skin pigmentation.
3. The measured value may be normal seemingly for the tester who has
anemia or dysfunctional hemoglobin(such as carboxyhaemoglobin
(COHb), methaemoglobin (MetHb) and sulfhaemoglobin (SuHb)), but the
tester may appear hypoxia, it is recommended to perform further
assessment according the clinical situations and symptoms.
4. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia,
as some severe anemia patients still show better pulse oxygen measured
valued.
5. Contraindication: no
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