DEVICE DETAILS
| NAME OF DEVICE | NONIN PALMSAT 2500 SERIES HANDHELD PULSE OXIMETER AND ACCESSORIES |
|---|---|
| ESTABLISHMENT NAME | ACUCARE SYSTEMS (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC4591820-38168 |
| BRAND NAME | NONIN PALMSAT 2500 SERIES HANDHELD PULSE OXIMETER AND ACCESSORIES |
| MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The PalmSAT 2500/2500A Pulse oximeters are digital handheld devices that display numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The 2500/2500A Pulse Oximeters will typically operate for 60 continuous hours between alkaline battery replacement or 40 hours with the optional Model 2500B Rechargeable NiMH (Nickel Metal Hydride) battery pack. The devices require no routine calibration or maintenance other than alkaline battery replacement or recharging the optional battery pack. A pulse oximeter determines functional oxygen saturation of the arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. The 2500/2500A must be used with Nonin-branded pulse oximeter sensors. |
| DEVICE INTENDED PURPOSE | The NONIN PalmSAT 2500 Pulse Oximeters are indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults, pediatric, infrant, and neonatal patients. The 2500/2500A pulse oximeters are intended for continuous monitoring and/or spot-checking of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused. |
| VALIDITY DATE OF REGISTRATION | 24/12/2019 - 23/12/2024 |