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The Wireless Vital Signs Monitor Professional (WVSM Pro) series monitors are intended to be used as continuous or spot check monitors and indicated as single or multi-parameter vital signs monitors. There are two monitor configurations WVSM Pro and TVSM (Tactical Vital Signs Monitor): WVSM Pro is indicated to monitor electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR). TVSM is indicated to monitor noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI), The monitors use wireless communications to transmit vital signs data to a PC, laptop, or mobile device. Patient population: neonate/infant, pediatric and adult patients. The monitors may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor is intended to be used by trained healthcare providers.

Wireless Vital Signs Monitor Professional (WVSM Pro) and Tactical Vital Sign Monitor (TVSM) are part of the WVSM Pro Series monitors. The WVSM® Pro series monitors are small, rugged, and highly mobile medical devices intended to be used as an adult, pediatric, and neonate patient vital signs monitor for spot-checking or continuous applications. The monitors are small enough to stay with the patient from point of injury through the triage and treatment process. It is designed as a single or multi-parameter vital signs monitor. The WVSM Pro is capable of acquiring the following physiological parameters: electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR). The TVSM is capable of acquiring the following physiological parameters: noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI). Both models can be used as a standalone device or can transmit data via wireless communications to a PC, laptop, or mobile device (tablet or smartphone). WVSM Pro series monitors are intended for use in pre-hospital, emergency room, inpatient care facilities, healthcare facilities, emergency medical applications, during transport, outpatient care, and other related healthcare scenarios. The WVSM Pro is intended to be used by trained healthcare providers by prescription only. The basic principles of operation of the WVSM® Pro Series monitors include: ECG: 5- or 12-lead waveforms generated via skin electrodes with right-leg drive. Note: The device does NOT include the following functions: Automated Waveform Measurements, Arrhythmia Detection, or Alarms for these functions. Capnography: Infrared (IR) Spectroscopy is used to detect CO2 concentrations in expired air via mainstream or sidestream methods Pulse oximetry: The plethysmography waveform from Red and IR LEDs are used to calculate functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI) Temperature: YSI 400 compatible thermistor sensors Non-invasive blood pressure (NIBP): Oscillometric method The WVSM® Pro Series patient monitor enclosures are primarily plastic and is not intended to contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact.