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The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, shortterm, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

The device consists of a modulator (an exhalation valve that opens at PIP and closes at PEEP), a mechanical manometer, a resistor (which is referred to as the PEEP Valve) attached within the exhalation path for elevating the PEEP further than can be set with the modulator, a patient connector tee to supply gas flow, entrain additional air, and connect to a face mask or a tube inserted into a patient's airway, and two associated accessories. It is intended to be used by properly trained personnel in any environment in which emergency ventilation is required. The VORTRAN GO₂VENT with PEEP Valve provides short-term, constant flow, pressure-cycled ventilatory support in either pressure control or pressure support mode. In pressure support mode, the rate dial of the VORTRAN GO₂VENT with PEEP Valve is set so that the baseline pressure is set above the set PEEP. This allows the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. In pressure control mode, the device will automatically cycle between PIP and PEEP when connected to a patient's airway. The working mechanism of the VORTRAN GO₂VENT with PEEP Valve consists of a moving diaphragm that opens the exhalation path when the pressure reaches PIP and closes when the pressure reaches PEEP. Without the PEEP Valve, PEEP will be approximately 20% of the set PIP. With the PEEP Valve attached, the PEEP will be increased from this value up to 24 cm-H₂O depending on the patient's compliance and the VORTRAN GO₂VENT with PEEP Valve's settings. The PEEP Valve is attached within the exhalation path by connecting it between the modulator and the patient connector tee. The pressure at which the diaphragm opens and closes against the valve is controlled by the amount of spring force acting against the diaphragm's movement. The spring force is adjusted by manually turning a threaded knob that varies the amount of spring compression. The device is constructed of a variety of plastics such as K-Resin, HDPE, polycarbonate, and silicone, as well as copper beryllium springs. The VORTRAN GO₂VENT with PEEP Valve is an external communicating device with limited and prolonged tissue contact duration (up to 30 days) via the breathing gas pathway. The associated accessories were included with the cleared predicate device (K162968) and include: - . Elbow flex hose for connecting the patient connector tee to a face mask or a tube inserted into a patient's airway - Oxygen tubing for connecting the patient connector tee to a gas supply

The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.

The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.

The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.

The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient's airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides. The manometer label has three color zones of green, yellow, and red to give enhanced visual support during ventilation. The color coded scale indicates the following: green is 0 to 20 cm-H2O; yellow is 20 to 40 cm-H2O, and red is for pressures above 40 cm-H2O. The color coded scale is only for visual support and the correct ventilation pressure must be determined by the medical professional.

The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).

The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via the connection tubing for monitoring cycling conditions of resuscitators such as the VORTRAN® Automatic Resuscitator.

The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

The VAR-Monitor is a battery (9 VDC) operated device that is mounted onto the VAR to monitor cycling conditions during operation.

The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

The VORTRAN Automatic Resuscitator (Model VAR-Plus) provides constant flow pressure cycled ventilatory support. The primary working mechanism of the VAR-PLUS is the Modulator which is an exhalation valve that opens at a set PIP (Peak Inspiratory Pressure) pressure and closes at a lower PEEP (Positive End Expiratory Pressure) pressure. During inhalation, exhalation will not start until the peak pressure is reached. During exhalation, inhalation will not begin until the pressure drops to PEEP. The rest of the VAR-PLUS consists of the Patient Connector Tee used to supply a flow of gas, entrain additional air, and provide a redundant pop-off valve