DEVICE DETAILS
| NAME OF DEVICE | LIFESENSE II CAPNOMETER/PULSE OXIMETER (MODEL LS1) AND RESPSENSE II CAPNOMETER (MODEL LS1R) |
|---|---|
| ESTABLISHMENT NAME | ACUCARE SYSTEMS (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC8480220-43563 |
| BRAND NAME | NONIN |
| MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The LS1 Family of capnography monitors include LifeSence II (Model LS1) and RespSense II (Model LS1R). The LifeSense II monitor includes Nonin OEM III Core SpO2 PureSAT technology platform, as the pulse oximetry signal processor. Both monitors are small, tabletop devices that simultaneously measure, display, monitor, and record the applicable parameters. The LifeSense II Capnography/Pulse Oximeter Monitor (Model LS1) simultaneously measures, display, monitors and records functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (EtCO2), respiration rate and pulse rate of well or poorly perfused adult, pediatric, and infant patients. The monitor displays real-time functional oxygen saturation of arterial hemoglobin (SpO2) and end tidal carbon dioxide (EtCO2) trend lines and numeric data. It is a battery-backed, mains-powered device equipped with audio and visual alarm indicators. The RespSense II Capnography Monitor (Model LS1R) simultaneously measures, displays, monitors and records functional end tidal carbon dioxide (EtCOs) and respiration rate of adult, pediatric, and infant patients. The monitor displays real-time end tidal carbon dioxide (EtCO2) trend lines and numeric data. It is a battery-backed, mains-powered device equipped with audio and visual alarm indicators. |
| DEVICE INTENDED PURPOSE | The LifeSense II, Model LS1, capnography/pulse oximetry monitor is indicated for use in simultaneously measuring, displaying, monitoring and recording functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (EtCO2), repiration, and pulse rate of well or poorly perfused adult, pediatric and infant patients. The RespSense II, Model LS1R, capnography monitor is indicated for use in simultaneously measuring, displaying, monitoring and recording end tidal carbon dioxide (EtCO2) and repsiration rate of adult, pediatric, and infant patients. Both models are intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, including hospitals, long-term care, medical faicilities, sleep laboratories, home healthcare, subacute environments, and Emergency Medical Services (EMS), including patient transport. |
| VALIDITY DATE OF REGISTRATION | 01/06/2020 - 31/05/2025 |