Patient Monitoring System
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·SternMed GmbH·Registered Nov 02, 2024- Analysis ID
- 2403034ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231229-0035
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- SternMed GmbH
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- SternMed GmbH
- Authorized Representative
- CÔNG TY TNHH ĐẦU TƯ PHÁT TRIỂN BNL
- Intended Use
- The Macs 10 patient monitor is a multifunctional device designed to monitor the vital signs of adult, pediatric, and neonatal patients. It features real-time recording and display of parameters such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, respiratory rate, CO2, body temperature, etc., which enable comprehensive analysis of the patient's physiological status. The Macs 20 and Macs 30 patient monitors are multifunctional devices designed to monitor the vital signs of adult, pediatric, and neonatal patients. They feature real-time recording and display of parameters such as ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiratory rate (RESP), body temperature (TEMP), as well as selective monitoring functions such as end-tidal carbon dioxide concentration (EtCO2), invasive blood pressure (IBP), cardiac output (C.O.), anesthetic concentration (AG), and the Cerebral State Index (CSI), etc., which enable comprehensive analysis of the patient's physiological status. The Macs 50 Monitor Screen is designed to be used for monitoring, displaying, reviewing, storing, and alarming multiple physiological parameters of adults, children, and neonates, including ECG, ST-segment analysis, arrhythmia analysis, tachycardia analysis, heart rate (HR), respiratory rate (RR), temperature (Temp), functional oxygen saturation of the pulse (SpO2), heart rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), impedance cardiography (ICG), carbon dioxide (CO2), nitrous oxide (N2O), and total hemoglobin (Sphb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet). The analysis of ICG and ST-segment are applicable only to adults. The following functions are not applicable to neonates: the Cerebral State Index (CSI) monitoring and the total hemoglobin (SCHb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet) monitoring. The EMS module, which includes ECG, respiratory rate, heart rate, SpO2, NIBP parameters, and temperature, is suitable for use during the transfer of patients
- Registration Date
- Nov 02, 2024
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Access comprehensive regulatory information for Patient Monitoring System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403034ĐKLH/BYT-HTTB and manufactured by SternMed GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ĐẦU TƯ PHÁT TRIỂN BNL.
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