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DEVICE DETAILS

NAME OF DEVICEHANDHELD PULSE OXIMETER (PC-66B)
ESTABLISHMENT NAMELEPU COMMERCE(MALAYSIA) SDN.BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC4172524-175148
BRAND NAMELEPU MEDICAL
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe pulse oximeter provides a non-invasive measurement of the arterial oxygen saturation (SpO2) and the heart rate (pulse rate). Oxygen saturation indicates the percentage of haemoglobin in arterial blood that is loaded with oxygen. Therefore, it is an important parameter for assessing respiratory function. ● 22-inch TFT display for Sp02, PI, Plethysmogram, PR ● MoveOxy SpO2 technology with artefact removal and anti- motion performance ● Various SpO probes for Adult, Paediatric, and Neonate • Inbuilt lithium battery for continuous monitoring ● Up to 384 hours SpO2 data storage for reviewing ● Adjustable alarm limit, pitch tone level, and key tone
DEVICE INTENDED PURPOSEThis Handheld Pulse Oximeter is intended for measuring and recording the pulse rate and functional oxygen saturation (SpO2). It is applicable for monitoring SpO2 and pulse rate of adult and paediatric patients in clinical institutions and homes.
VALIDITY DATE OF REGISTRATION25/06/2024 - 24/06/2029

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