Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.
Model
SONOSAT-W01T
Device description
This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing.The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.The power supply is 4.2V Li-battery and also the subject device can be powered by adapter.The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR).The subject device is not for life-supporting or life-sustaining and it is not an implantable device.The subject device owns software which has been validated by the manufacturer.
An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.