Specifications

2 Warnings, Cautions, and Notes
Chapter 2 Warnings, Cautions, and Notes
Warning: Indicates the possibility of injury to the patient or the operator.
Caution: Indicates the possibility of damage to the device.
Note: Places emphasis on an operating characteristic.
Warnings
• This manual serves as a reference. It should be used in conjunction with the instructions and
protocol set by the physician at the institution where the device is being used. The instructions in
this manual are not intended to supersede established medical protocols regarding the use of
assist ventilators.
• The BiPAP S/T System is an assist ventilator and is intended to augment the ventilation of a
spontaneously breathing patient. It must not be used as a life support ventilator. It is not
intended to provide the total ventilatory requirements of the patient.
• The BiPAP S/T should not be applied to patients who are incapable of maintaining
life-sustaining ventilation in the event of malposition of the patient interface.
• The BiPAP S/T is intended for use on patients one year of age and older.
• The BiPAP S/T is intended for use with a Respironics, Inc. approved patient circuit only. A
Respironics approved circuit consists of :
– smooth inner lumen tubing,
– an exhalation device such as the Whisper Swivel
®
II, Plateau™ Exhalation Valve, or
Respironics Disposable Exhalation Port Assembly, and
– a noninvasive patient interface (nasal mask, mouthpiece, or full face mask).
Additional accessories may be added to the circuit to meet specific needs. Every time changes are
made to the circuit configuration, the delivered pressures must be monitored at the patient
connection with the unit cycling. If using other patient circuits, they must have a continuous leak
exhalation port with flow comparable to Respironics exhalation ports.
• The continuous flow exhalation port (e.g., Whisper Swivel II) is designed to exhaust patient
exhalation from the patient circuit. Continuous flow is required for safe operation. Do Not Block
or Otherwise Try to Seal the Vents on the Exhalation Port.
• In situations where risk of contamination between the user and the BiPAP unit is high, a low
resistance, main flow bacteria filter should be placed in-line between the unit and the patient.
• All patient settings must be determined via appropriate diagnostic testing and monitoring by the
prescribing physician. Delivered pressures must be monitored at the patient connection with the
unit cycling.
• Each time changes are made to the circuit configuration, confirm that delivered pressures are
adequate for patient management.
• Explosion Hazard - Do not use the BiPAP S/T System in the presence of flammable anesthetics.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an
open flame.
• Do Not add oxygen to the front of a BiPAP unit (at the inlet filter opening).
• BiPAP S/T System performance should be verified, as described in Chapter 9, before each new
patient is placed on the system.
• If the BiPAP S/T begins to function incorrectly, discontinue use and contact your health care
dealer or Respironics, Inc.