A-A-54444
ventilator apparatus shall include a means by which to automatically activate assist-control breathing at the ventilator rate/inspiratory time setting, or 12 breaths per minute/inspiratory time setting, whichever is greater. The apnea alarm shall be cancelable, not mutable.
The unit shall have a CPU failure alarm that shall activate whenever the CPU fails to successfully complete a functional self-check when the ventilator apparatus is placed in an operating mode or detects an operational fault during the course of operation. The CPU failure alarm shall not be mutable or cancelable.
An inverse I:E ratio alarm shall activate whenever inspiratory time exceeds expiratory time shall be provided. This alarm shall only be canceled by the operator lessening the inspiratory time control setting or lessening the rate control setting. The inverse I:E alarm shall not be mutable.
The ventilator shall have a pressure transducer calibration alarm that shall activate when the CPU detects a “non-zero” pressure transducer reading when exposed to an open atmosphere. The pressure transducer calibration alarm shall not be mutable. The alarm shall only be canceled by recalibrating the pressure transducer.
The apparatus shall have a battery operating time of at least 11 hours of continuous operation without diminishment of operating capability. Battery shall not deplete more than approximately 1.5 percent per month or 18 percent per year if stored at 70°F.
All circuitry within the ventilator and separate AC power supply shall be designed to conform within the electromagnetic interference/radio frequency interference requirements.
Dimensions of the self-contained ventilator apparatus shall not exceed 10 inches by 5.0 inches by 12 inches.
The self-contained ventilator apparatus, less all other components, shall not weigh more than 12 pounds.
Marking case containers. If the unit requires restricted conditions of storage, then the exterior markings of the over packaging, the carry-all carrying case, and the self-contained ventilator separate container shall indicate the required storage temperature and humidity.
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