• 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.
• Consult a physician or dentist if you encounter tooth, gum,
or jaw soreness. Use of a mask may aggravate an existing
dental condition.
• A minimum of 3cm H
using this mask.
• Attaching an exhalation device requires therapy pressure
level adjustment to compensate for increased leak.
• Do not block or seal off the entrainment valve.
Contraindications
This mask may not be suitable for persons with the following
conditions: impaired cardiac sphincter function, excessive
reflux, impaired cough reflex, and hiatal 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.
• Wash your face. Do not use moisturizer/lotion on your hands or face.
• Inspect the mask and replace it if the cushion has hardened or is torn, or if any parts are
broken.
• Verify that the therapy device, i.e., ventilator, including the alarms and safety systems, has
been validated prior to use.
• Verify therapy device pressure(s).
Verify the Entrainment Valve
The entrainment valve consists of an air inlet and a flapper. With the airflow
turned off, verify that the elbow with the flapper is lying flat (Figure 2A)
so that room air can flow in and out through the air inlet. Next, with the
airflow on, the flapper should now cover the air inlet and air from the CPAP
or bi-level device should flow into the mask (Figure 2B). If the flapper does
not close or does not function properly, replace the mask.
Warning: Do not block or seal the entrainment valve.
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 mask in warm water with liquid dishwashing detergent.
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.
Caution: Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol,
or cleaning solutions containing conditioners or moisturizers.
Caution: Any deviation from these instructions may impact the performance of the
product.
2
O (hPa) must be maintained when
2
A
B
C
D
Figure 1
A Top Headgear Straps
B Integrated Cushion/Faceplate
C Bottom Headgear Straps
D Entrainment Valve Air Inlet (Do Not
Block)
E Push Button Adjuster
F Forehead Pad Support
G Frame with Elbow
H Exhalation Port (Do Not Block)
I
Headgear Clips
J
Quick Release Swivel
2A
2B
E
F
G
H
I
J
Figure 2