DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | BIOMETRIXS MEDITRONIXS GLOBAL |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC5843323-144456 |
| BRAND NAME | ACCURO |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | A Pulse oximeter (ACCURO) is detecting and measurement as below parameters to provide and help doctors for making figure out the patient’s vital condition: - Exact and stable oxygen saturation of arterial blood SpO2 (continuous measurement) The SpO2 function is indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients. The device works by applying a sensor to a pulsating arteriolar vascular bed. The SpO2 can be measured non-invasively on patient’s finger or earlobe. An LED in a sensor serves as a light source to emit red and infrared (IR) light alternately. The blood in capillary absorbs these lights, and the transmitted light is detected with a photodiode on the other side. The device is composed of finger probe and SpO2 module. SpO2 module drives currents into RED and IR LEDs in the SpO2 probe. Then the LEDS emit RED and IR light into the finger nail which is just below the LEDs. The sensor of the finger probe below the finger receives the RED and IR light and intensity of each light is translated into voltage. Voltages for RED and IR light signal are transformed to digital data using A/D converters in SpO2 module. After the conversion, the CPU in the SpO2 module calculates the RED to IR intensity ratio to obtain the corresponding SpO2 value. It also calculates the heart rate from the pulsating feature of input signal. To eliminate the influence of noise and patient’s motion, digital signal processing algorithms are adopted in calculating SpO2 and pulse rate values. |
| DEVICE INTENDED PURPOSE | The intended use of Pulse oximeter ACCURO is detecting and measurement as below parameters to provide and help doctors for making figure out the patient’s vital condition. • Exact and stable Oxygen saturation of arterial blood • Accurate Pulse Rate Especially, Pulse oximeter ACCURO has AGC (Auto Gain Controller) function for weak pulsatile patients. The device is to detect and control its gain automatically in accordance with patient’s pulse rate strength. |
| VALIDITY DATE OF REGISTRATION | 11/08/2023 - 10/08/2028 |