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rial ductus or intraluminal tube.
% The measured value may be inaccurate during defibrillation and in a short period af-
ter 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 re-
quirements of IEC 60601-1.
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 tem-
perature, major bleeding, or use of vascular contracting drug, the SpO
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 indocy-
anine green or methylene blue), skin pigmentation.
C.The measured value may be normal seemingly for the tester who has anemia or dys-
functional 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.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some se-
vere 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.
10
waveform (PLETH)
2
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