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Chapter 1 Introduction
3
Warnings and Cautions
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
Warnings
A warning indicates the possibility of injury to the user or operator.
Patient Monitoring Prior to placing a patient on the ventilator, a clinical assessment should
be performed to determine:
• The device alarm settings
• Needed alternative ventilation equipment
• If an alternative monitor (i.e., an alarming Pulse Oximeter or
Respiratory Monitor) should be used
Alternative
Ventilation
For ventilator dependent patients, always have alternate ventilation
equipment, such as a back-up ventilator, manual resuscitator, or similar
device, available.
Ventilator dependent patients should be continuously monitored by
qualied personnel. These personnel should be prepared to provide
alternate therapy in the event of ventilator failure or inoperative
equipment.
Patient Disconnect
Protection
For ventilator dependent patients, do not rely on any single alarm
to detect a circuit disconnect condition. The Low Tidal Volume, Low
Minute Ventilation, Low Respiratory Rate, and Apnea alarms should
be used in conjunction with the Circuit Disconnect and Low Peak
Inspiratory Pressure alarms.
Test the operation of the circuit disconnect function daily and
whenever a change is made to the patient circuit. An increase in circuit
resistance can prevent proper operation of some alarms.
Speaking valves, Heat Moisture Exchangers (HMEs), and lters create
additional circuit resistance and may aect the performance of alarms
chosen for circuit disconnect protection.
Do not set the Low Peak Inspiratory Pressure alarm too low, or the
system may not detect large circuit leaks or a patient disconnect.