DEVICE DETAILS
| NAME OF DEVICE | DESKTOP PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | MEDIC DOT COM SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC875871066418 |
| BRAND NAME | CONTEC |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SINGLE |
| DEVICE DESCRIPTION | THE PULSE OXYGEN SATURATION IS THE PERCENTAGE OF HBO2 IN THE TOTAL HB IN THE BLOOD, SO-CALLED THE O2 CONCENTRATION IN THE BLOOD. IT IS AN IMPORTANT BIO-PARAMETER FOR THE RESPIRATION. MANY OF THE RESPIRATION DISEASE WILL CAUSE HYPOXEMIA, EVEN DAMAGE THE PATIENT’S LIFE. AS A RESULT, MONITORING THE SPO2 IS INDISPENSABLE IN THE CLINICAL RESCUING. THE TRADITIONAL METHOD TO MEASURE SPO2 IS TO ANALYZE THE SAMPLE OF THE PATIENT’S BLOOD TO GET THE PARTIAL PRESSURE OF OXYGEN AND CALCULATE THE SPO2 BY USE THE BLOOD-GAS ANALYZER. THIS METHOD IS INCONVENIENT AND DISCONTINUOUS. FOR THE PURPOSE OF MEASURING THE SPO2 MORE EASILY AND ACCURATELY, OUR COMPANY DEVELOPED THE PULSE OXIMETER. THE DEVICE CAN MEASURE THE PULSE RATE SIMULTANEOUSLY. THE PULSE OXIMETER IS PORTABLE, AND WITH LOW POWER CONSUMPTION, CONVENIENT TO USE AND CARRY. YOU JUST NEED TO PUT THE FINGERTIP INTO THE SENSOR OF THE DEVICE, THE SPO2 VALUE WILL APPEAR ON THE SCREEN IMMEDIATELY. IN THE CLINICAL PRACTICE, THE TOLERANCE IS SMALLER THAN ±2% IN THE RANGE FROM 70% TO 99%. |
| DEVICE INTENDED PURPOSE | THE DEVICE CAN BE USED IN MEASURING THE PULSE OXYGEN SATURATION AND PULSE RATE THROUGH FINGER. THE PRODUCT IS SUITABLE FOR BEING USED IN FAMILY, HOSPITAL, OXYGEN BAR, COMMUNITY HEALTHCARE, PHYSICAL CARE IN SPORTS (IT CAN BE USED BEFORE OR AFTER DOING SPORTS AND IT IS NOT RECOMMENDED TO USE THE DEVICE DURING THE PROCESS OF HAVING SPORT) AND ETC. |
| VALIDITY DATE OF REGISTRATION | 06/06/2018 - 05/06/2023 |