or after removing it: Unusual chest discomfort, shortness of breath, stomach distension,
belching, or severe headache; drying of the eyes, eye pain, or eye infections; blurred vision.
(Consult an ophthalmologist if symptoms persist.)
• 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.
• This mask should not be used on patients who are uncooperative, obtunded,
unresponsive, or unable to remove the mask.
• This mask is not recommended if the patient is taking a prescription drug that may
cause vomiting.
• If an additional exhalation device is added to the patient circuit, you may need to adjust
the pressure level to compensate for the additional leak of the exhalation device.
• This mask does not include an anti-asphyxia valve that would allow a patient to breathe if
the ventilator failed.
• The gel mask is not customizable. Do not attempt to heat.
• Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing, tears,
cushion damage resulting in gel exposure, etc). Discard and replace any components as
necessary.
• This mask is for single use only and is not intended to be disinfected or cleaned after
patient use. Dispose of the mask after patient use. Multi-patient use without disinfection
between patients increases the risk of infection.
• This mask is not designed for reuse. Respironics cannot
guarantee the performance specifications once this mask has
been disinfected or cleaned after patient use.
• Use of a nasal or full face mask may cause tooth, gum, or jaw
soreness or aggravate an existing dental condition. Consult your
physician or dentist if symptoms occur.
Contraindications
This mask is contraindicated for patients without a spontaneous
respiratory drive. This mask may not be suitable for persons with the
following conditions: impaired cardiac sphincter function, excessive
reflux, impaired cough reflex, and hiatial hernia. It should not be
used if the patient is uncooperative, obtunded, unresponsive, or
unable to remove the mask by themselves.
Before Use
• Read and understand the instructions completely.
• Hand wash the mask.
• Clean the patient's face.
• Verify that the mask and headgear are the correct size.
• If a nasogastric (NG) tube or similar device is in place, use the
optional NG tube sealing pad. Position the pad so that its flat
surface is against the patient's face and the C-shaped opening
surrounds the tube.
• Verify that the therapy device, i.e., ventilator, including the alarms
and safety systems, has been validated prior to use.
• Check for the blue elbow on the mask, and note that the mask does not include an anti-
asphyxia valve that would allow a patient to breathe if the ventilator failed.
• Inspect the mask and replace it if the cushion has hardened or is torn, or if any parts
are broken.
• Verify therapy device pressure(s).
2
A
G
F
E
D
Figure 1
A = CapStrap
B = Forehead Bracket and
Forehead Pad
C = Swivel Clip
(ball and socket)
D = Blue 22 mm Standard
Elbow (SE)
E = Faceplate with
Gel Cushion
F = Four Position
Forehead Arm
G = Headgear Strap
B
C