2
3
port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.
•
A minimum of 3cm H
2
O (hPa) must be maintained when using this mask.
•
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.
•
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.
•
Do not block or try to seal 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 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.
•
Verify that the air entrainment valve functions correctly,
as noted below.
•
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).
Cleaning Instructions
1. Hand wash the mask in warm water with a mild dishwashing
detergent.
Caution:
Use a mild liquid dishwashing detergent only. Do not
use bleach, alcohol, or cleaning solutions containing bleach
or alcohol, or cleaning solutions containing conditioners or
moisturizers.
2. Rinse thoroughly and air dry completely before use.
Air Entrainment Valve
1. Locate the air entrainment valve flapper inside the mask elbow.
2. With the airflow turned off, the entrainment valve flapper will lie flat, so that room air
can flow through the fresh air inlet in the valve.
3. With the airflow on, the flapper will now cover the fresh air inlet and air from the CPAP
or bi-level device should flow into the mask.
4. Do not block or try to seal the fresh air inlet in the elbow. Ensure that the entrainment
valve is not blocked with secretions and that the flapper is dry. If the flapper does not
function properly, replace the mask.
Leak Symbol and Port Settings
Some ventilators may incorporate the use of a leak symbol and value in the mask selection
setup procedures. The leak characteristics of this mask is leak symbol ( ). The leak symbol
and value represents the intentional leak characteristics of the interface. On ventilators
equipped with a Mask Selection control, enter the leak symbol value ( ) that corresponds
with the leak symbol value on the mask.
Achieving the Right Fit
1. Hold the mask lightly against the patient’s face and slide the CapStrap headgear over their
head. Connect the ball-and-socket swivel clips after the headgear is in position with the
headgear tabs facing outward.
2. Adjust the position of the forehead arm to ensure minimal mask contact pressure on the
nasal bridge while achieving minimal mask cushion leak. The lowest position provides the
highest contact pressure at the bridge of the nose and provides the
best mask cushion seal. The highest position provides the lowest
contact pressure at the bridge of the nose and provides lower mask
cushion seal.
3. Connect the patient circuit (exhalation device and flexible tubing) to
the mask
elbow with air entrainment valve.
4. Unfasten the headgear tabs on the top strap of the CapStrap and
gradually adjust to ensure the mask is tight enough to achieve minimal
mask cushion leak and a comfortable fit. DO NOT OVERTIGHTEN.
Unfasten the headgear tabs at the swivel clips and gradually adjust to ensure the mask
is tight enough to achieve minimal mask cushion leak and a comfortable fit. DO NOT
OVERTIGHTEN.
5. Turn on the noninvasive ventilator. Instruct the patient to breathe normally.
6. Make final adjustments to all adjustment points to manage leaks and to provide
a comfortable fit.
Notes:
•
Re-adjust the strap tension if leaks occur as the patient’s position changes.
•
Do not overtighten the straps. Overtightening can cause or worsen leaks.
Connecting and Disconnecting the Headgear
The CapStrap headgear design provides the opportunity for greater headgear positioning
and comfort. This mask can also be used with the Four Point Headstrap with swivel clips
(REF 1015788).
A
B
C
E
F
G
H
D
Figure 1
A = CapStrap
B = Forehead Bracket and
Forehead Pad
C = Swivel Clip (ball and
socket)
D = Mask Leak Symbol and
Value
E = Entrainment Valve with
Fresh Air Inlet
F = Faceplate with Gel
Cushion
G = Four Position Forehead
Arm
H = Headgear Strap
Figure 2
