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The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator thus providing emergency respiratory support. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his her negative inspiratory force and the source gas being delivered to the patient through a face mask. Additionally, there is a non-rebreathing valve (reusable version or single patient use version) attached to the Bi-Flow D/R which directs the patient's exhalation back to atmosphere. The combination of the Bi-Flow D/R and the non-rebreathing valve as a single device is commonly referred to as a Demand Valve. The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device. The Bi-Flow D/R will be sold by Spiracle Technology only by or on the order of a physician and is intended to be used exclusively by trained health care professionals. The Bi-Flow D/R will be sold as a component of a respiratory support system to be configured by the health care provider. As such, it will be compatible with all commonly available oxygen source and face mask connections.

The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. The small portable device is primarily constructed of aluminum components and utilizes a plastic and silicone rubber inhalation valve. The device is gas powered and has no electronic components or software. The device is pilot actuated.

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor vontilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor ventilatory functions. It is a small, portable battery operated device that attaches to bag mask resuscitators, oxygen powered demand valve resuscitators or automatic transport ventilators, which may not be equipped with pressure gauges for the purpose of patient airway monitoring. The TDx PRM monitors the following patient parameters: peak inspiratory pressure, breath frequency, inspiratory and expiratory times, positive end expiratory pressure ("PEEP"). The TDx PRM also offers a cardiopulmonary resuscitation metronome to assist in the pacing of cardiopulmonary resuscitation efforts. The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor and does not provide any patient alarms. Moreover, the TDx PRM has no direct patient contact; transmission of airborne pathogens is prevented by means of standard bacterial filters such as are routinely used with emergency resuscitation equipment. The TDx PRM is a microprocessor-controlled device that utilizes a electronic pressure transducer.