• If oxygen is used with the device, the oxygen flow must be turned off when the device is
not operating. Explanation of the Warning: When the device is not in operation, and the
oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within
the device enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
• Do not block or seal off the exhalation ports.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will
vary, depending on the pressure settings, patient breathing pattern, mask selection, and the
leak rate. This warning applies to most types of CPAP and bi-level machines.
• At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate
to clear all exhaled gas from the tubing. Some rebreathing may occur.
• Attaching an exhalation device requires therapy pressure level adjustment to compensate
for increased leak.
• This mask can be used with devices that offer System One resistance compensation enabled
by your provider and this mask can be used with the Trilogy device utilizing pressure control
modalities.This mask can be used on devices without System One resistance compensation
if operating with auto-titration disabled or without auto-titration capabilities.
• Disconnect sensing systems on ventilators may not work as expected with pillows cushions.
Caregiver should visually monitor patients for disconnects or use an alternate interface.
Do not rely on any single alarm to detect a patient disconnect condition. The Low Tidal
Volume, Low Minute Ventilation, Low Respiratory Rate and Apnea alarms (if available)
should be used in conjunction with this mask to ensure proper ventilation. Explanation of
the Warning: The ventilator disconnect alarm attempts to detect changes in patient circuit
resistance (including the filter, humidifier, tubing, and mask) while connected to the patient.
In the event the patient becomes disconnected from the interface during ventilation with
the pillows cushions, the circuit resistance change is not sufficient to activate the disconnect
alarm. Therefore, the circuit disconnect alarm may not function.
Before Use Read and Understand the Instructions Completely.
• Hand wash the entire mask.
• Wash your face. Do not use moisturizer/lotion on your hands or face.
• Inspect the mask. Replace the cushion if it has hardened or torn, or any parts that are
broken.
Cleaning Instructions
Hand wash the mask before first use and daily. The headgear should be hand washed weekly, or as
needed. The headgear does not need to be removed for daily cleaning of the mask.
1. Hand wash the mask and headgear in warm water with a liquid dish washing detergent.
Cautions:
• Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or cleaning solutions
containing conditioners or moisturizers.
• Any deviation from these instructions may impact the performance of the product.
• Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard and replace any
components as necessary.
2. Rinse thoroughly. Air dry completely before use. Make sure the mask is dry before use. Lay the
headgear flat or line dry. Do not place the headgear into the dryer.
Institutional Disinfection
For multi-patient use in the hospital/institutional environment, use the Disinfection Guide to
reprocess the mask between patients. These instructions can be obtained by visiting us online at
www.philips.com/respironics or by contacting Philips Respironics Customer Service at 1-800-345-
6443 (USA or Canada) or at 1-724-387-4000.
2