DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | SILVER STATE LABORATORY SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6526324-183121 |
| BRAND NAME | JUMPER |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | Oxygen saturation is the percentage of oxyhaemoglobin (HbO2) that is combined with oxygen against all combinable haemoglobin (Hb). It is an important physiological parameter involved in respiration and circulation. The oxygen saturation of arterial blood in a normal human body is 98%. Oxygen saturation is an important indicator of the oxygen condition in the human body. In general, the normal values of oxygen saturation shall not be lower than 94%. If the measured value of oxygen saturation is lower than 94%, an insufficient supply of oxygen is considered. The pulse rate is the number of pulse beats per minute. Normally, the pulse rate is consistent with the heart rate. In general, the pulse rate of every people is 60 to 90 beats per minute. The Perfusion Index (PI) usually reflects the limb perfusion status of an examined patient, and shows the detection precision of the instrument as well; that is, examination can still be performed even in the low or weak perfusion condition. The PI of a normal human body is 3% or greater. It is applicable to a wide range of fields, such as families, hospitals, oxygen bars, social medical care institutions, and sports & health. Use this instrument for measurement before or after sports. You are not advised to use this instrument during sports activities. Do not use it for continuous care for patients. It adopts photoelectric oxyhemoglobin inspection technology in accordance with capacity pulse scanning recording technology, which can be used to measure human oxygen saturation & pulse rate through finger The device is suitable for daily care in family, hospitals, oxygen bars, community healthcare and physical care in sport, etc. it can be used before or after exercise. It is recommended to measure in a calm state |
| DEVICE INTENDED PURPOSE | The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments. |
| VALIDITY DATE OF REGISTRATION | 26/08/2024 - 25/08/2029 |