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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEONECARE BIOTECH SDN BHD
REGISTRATION NOGC3880222-83400
BRAND NAMELEPU
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe product is mainly indicated for measurement of human Oxygen Saturation (SpO2), Pulse Rate (PR) and PI(Perfusion Index). The product has visual prompts and verbal prompts , such as finger out and pulse sound (optional). The applied part of this device is silica gel pad. The measuring principles of pulse oximeter is based on Lambert Beer law, The spectrum absorption characteristics is different of Reductive hemoglobin(RHb) and Oxyhemoglobin(Hbo2) in red light and nearinfrared light zones. The pulse oximeter calculate Spo2 ,PR and PI from the light intensity absorption difference by measuring the ratio of absorbed red and infrared light with each pulse.
DEVICE INTENDED PURPOSEThe LOX100 Fingertip Oximeter is intended for use in homes or hospitals for noninvasive measurement of oxygen saturation, pulse rate and perfusion index. The device can be used for both children and adults. This device is intended only for spotchecking.
VALIDITY DATE OF REGISTRATION16/01/2022 - 15/01/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fingertip Pulse Oxymeter (Blue)LOX100A
2Fingertip Pulse Oxymeter (Green)LOX100B
3Fingertip Pulse Oxymeter (Cyan)LOX100C
4Fingertip Pulse Oxymeter (Yellow)LOX100D