DEVICE DETAILS
| NAME OF DEVICE | HANDHELD PULSE OXIMETER (AH-MX) |
|---|---|
| ESTABLISHMENT NAME | GASWORLD SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC10576623-150448 |
| BRAND NAME | ACARE |
| MEDICAL DEVICE CATEGORY | MD 1301 - Monitoring devices of non-vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | The AH-MX handheld pulse oximeter is intended for continuously monitoring or spot checking peripheral oxygen saturation (SPO2) and pulse rate (PR) for adult, pediatric or neonatal patients. The device can be used in institutions or unit with health care capability. This includes outpatient departments, emergency rooms and departments of internal medicine in hospitals, ordinary departments in clinics, nursing hospitals and community medical instructions, it many also be used in the home. The Handheld type oximeter can be used to measure human Haemoglobin Saturation and heart rate through finger. The product is suitable for use in family, hospital (including clinical use in internist/surgery, Anaesthesia, paediatrics, intensive care and etc.) Oxygen Club, social medical organizations, physical care in sports (It can be used before or after sports.) In the same time, doctor can use the waveform end-user’s current SPO2 volume curve. Pulse oximeter is a very important and common device to check patient's blood oxygen saturation (SPO2) level and pulse rate. As a portable, compact, simple, reliable and durable physiological monitoring device, handheld pulse oximeter AH-MX can greatly enhance patient care. It is widely applied in clinic, hospital, social medical organizations, and first aid and so on. - Light and compact handheld design - High resolution 2.4'' color display - Gravity sensor automatically change the direction of display - Visual and sound alarms - Convenient AA size alkaline or rechargeable Li-ion battery - With medical grade AC/DC adapter - With cardle as power charger |
| DEVICE INTENDED PURPOSE | The AH-MX handheld pulse oximeter is intended for continuously monitoring or spot checking peripheral oxygen saturation (SPO2) and pulse rate (PR) for adult, pediatric or neonatal patients. The device can be used in institutions or unit with health care capability. This includes outpatient departments, emergency rooms and departments of internal medicine in hospitals, ordinary departments in clinics, nursing hospitals and community medical instructions, it many also be used in the home. |
| VALIDITY DATE OF REGISTRATION | 09/10/2023 - 08/10/2028 |