75
• As the measure is taken on the basis of arteriole pulse, substantial pulsating blood ow of subject is required. For a sub-
ject 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.
• The accuracy of the readings under weak perfusion has been veried using signals from the patient simulator. The SpO2
and pulse rate values vary within the measurement range due to various weak signal conditions and are compared to the
actual SpO2 and pulse rate values of the known input signals.
• The claim for SpO2 accuracy should be supported by clinical research measurements covering the entire spectrum. By
articially inducing to different stable oxygen levels, make it in the range of 70% ~ 100% of SpO2. Use secondary stand-
ard SpO2 measuring equipment for comparison to collect SpO2 values together with the tested product, compose paired
data groups for accuracy analysis.
• Clinical report records data of 12 healthy volunteers, including 6 females and 6males. Volunteers’ age ranges from 21 to
29. Skin color is distributed from dark to light, including 3 dark black skins, 2 medium black skins, 5 light skins, 2 white
skins.
• When using the device, please keep it away from the instruments that can generate strong electric or magnetic eld.
Use the device in an inappropriate environment may cause interference to the surrounding radio equipment or affect its
working.
• If necessary, please log on our company’s ofcial website to download the list of SpO2 probes and extension cords that
can be used in conjunction with this device.
Warning
• Check if the cable of SpO2 probe is in normal condition before measuring. After unplugging the SpO2 probe cable from
the socket, “SpO2%” and “bmp” on the screen will disappear.
• Do not use the SpO2 probe once the package or the probe is found damaged. Instead, you shall return it to the vendor.
• The supplied SpO2 probe is only suitable for use with this device. This device can only use the SpO2 probe described
in this manual. It is the responsibility of the operator to check the compatibility of the device and the SpO2 probe (and
extension cable) before use. Incompatible accessories may result in device performance decreasing or cause injury to
the patient.
• SpO2 probe is a medical product that can be used repeatedly.
• The measured value may be normal seemingly for the testee who has anemia or dysfunctional hemoglobin (such as car-
ENGLISH