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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.

The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. The modification to the WVSM includes: Adding an indication for capnography by interfacing with a FDA cleared accessory. Adding the capability to use the device while connected to the AC power adapter instead of only using the device on battery power.

The intended use of the ADMS software application is to: Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients. Display visual alarm conditions as generated by a connected monitor. Display of patient information can be real-time or historical record review. Provide review and trend application data, designed to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. ADMS is intended for use in professional healthcare facilities, emergency medical applications, during transport, and other healthcare environments by trained healthcare professionals. ADMS Software is not intended for home use. Indicated for use for specific patient populations (adult, pediatric, infant/neonate) depends on the indicated labeling of medical device(s) connected to ADMS providing the data.

The Athena GTX Device Management Suite (ADMS) is a software only device that manages patient data from compatible monitoring devices. The Athena GTX Device Management Suite (ADMS) receives, distributes and displays physiologic waves, parameters and visual alarms at locations other than at the patient, for multiple patients. Data is generate by compatible connected devices and can be real-time or historical review. The Athena GTX Device Management Suite provides a method of controlling ADMS compatible devices and viewing the device's data on Android devices (smartphones and tablets), iOS devices (smartphones and tablets) and on PCs running Windows OS. The ADMS software receives data using Wi-Fi (802.11) from any Athena device within range. Whenever a device comes within range of ADMS, it will start receiving data from the device automatically. Commands to devices is transmitted via Wi-Fi (802.11) to the device. Each platform running ADMS can support viewing up to twenty (20) devices at one time. The Athena GTX Device Management Suite (ADMS) consists of software only applications that do not come into physical contact with patients.

The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.

The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry. The WiCap Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WiCap monitor. WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.

The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.

The TACVAC™ portable battery powered suction device is designed for the same application and intended use as the SSCOR, Inc. Jr® Quickdraw, Model 2400 listed predicate device. The TACVAC™ portable battery powered suction device is capable of the same functions as have been provided by the predicate device referenced above. The TACVAC™ consist of both re-useable and disposable (one-time use components). The device is very light weight (8 ounces) and can be compactly stowed (7.25" x 7.38" x 3.0") by inserting the suction unit inside the bottle to reduce space required to carry the device to the point of injury. To assemble from the stowed condition the valve unit is simply removed (unscrewed from the bottle) and the suction unit is removed. Then the valve unit is replaced back on the bottle and the suction unit is inserted into the valve unit and locked in place by twisting to engage the bayonet fittings. The assembled size is 7.25" x 11.88" x 3.0". A third party suction tip is installed on the suction tubing and then the unit can be turned on/off with the power switch. Once the unit is switched on suction will build in the bottle. Suction is applied at the suction tip by depressing the suction button. The device must be kept upright during use to prevent the overfill float check valve from engaging and shutting off suction to the tip. Once the user has finished using the device on a particular patient the valve unit, bottle and suction tip are discarded. The Suction unit is to be cleaned and disinfected. New batteries are installed as required to ensure full suction and use time. A new valve unit, bottle and suction tip are needed for the next use of the device.

The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or mufti-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC), Personal Digital Assistant (PDA) or Mobile device.

The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over. The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions. Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm. Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application. Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.

The Athena GTX mini-Medic™ wireless vital signs monitor system is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit time (PWTT). Vital signs are displayed directly on the forehead sensor and transmitted wirelessly to a handheld display unit. Reports and data file saving is done via wireless download to a PC.

The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor far ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC) or Personal Digital Assistant (PDA).