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The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Testa, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a pressure generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the babyPAC ventilator (K970158) already on the market. The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and for resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg). The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the controls for the gauge and internal pneumatics are recessed to minimise the possibilities of damage and inadvertent operation. The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector The module weighs 8.25 lb (3.75 kilograms) The module control panel has the following features: - Adjustable Relief Pressure Control, range 12 to 80 cm H2O. - Inspiratory Time Control, range 0.25 to 2.0 seconds. - Expiratory Time Control, range 0.25 to 4.0 seconds - Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O. - PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O. - IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected. - Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. - Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 to 70 % with oxygen and air supplies - Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure they show red, with adequate pressure they show white. Any visible red indicates that the supply should be changed. As the pressure falls the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority (to EN 475: 1995) audible warning. - Electronic alarm bezel indicating - High Pressure/ Constant Positive Inflation Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure - Inflation Indicator Flashes Green LED every time inflation pressure rises through 10 cm H2O. - Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within eight seconds - Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced. - Single Gas Use Indicator Flashes a Green LED as a burst of 3 flashes every 30 seconds, whenever the ventilator is being used with only a single gas input (ie oxygen or air only). In the event that the single gas fails (ie. where the audible gas failure alarm has activated) the Low Pressure/ Disconnect Indicator will activate together with the audible alarm. - Low battery indicator Flashes Yellow LED with audible alarm.