Device Dossier

Patient monitor, multiparameter

Device Dossier for Patient monitor, multiparameter (Single-patient physiologic monitoring system, Class IIb, sponsor Welch Allyn). ARTG record, intended…

Intended purpose

Intended Purpose The CVSM 6000 series of single patient monitoring systems are intended for monitoring of neonatal, pediatric, and adult patients for the following general physiology/vital sign parameters via a combination of CVSM 6000 modules: o noninvasive blood pressure, o pulse rate, o noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), o hemoglobin concentration (SpHb), o respiration rate (RRa) o monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, o Integrated Pulmonary Index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate, o body temperature in normal and axillary modes, o measurement of respiration rate, heart rate and patient movement o (Via USB port connection, rather than module) Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. This product is available for sale only upon the order of a physician or licensed health care professional and only to be used by clinicians and medically qualified personnel.

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