Owner’s Manual
Invacare®Twilight™Full
Face Mask
LATEX
FREE
This owner’s manual is to be used in conjunction with the
supplemental sheet provided, part no. 1150693.
USER: Before using this product, read the owner’s manual
and supplemental sheet and save for future reference.
DEALER: The owner’s manual and supplemental sheet MUST
be given to the end user.
For more information regarding
Invacare products, parts, and services,
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TABLE OF CONTENTS
TABLE OF CONTENTS
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The benefits of registering include:
1. Safeguarding your investment.
2. Ensuring long-term maintenance and servicing of your product.
3. Receiving updates with product information, maintenance tips and industry
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Register ONLINE at warranty.invacare.com
Please have your model number and purchase date available to complete your
registration.
Any registration information you submit will only be used by Invacare
Corporation and protected as required by applicable laws and regulations.
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SECTION 1—GENERAL GUIDELINES
SECTION 1—GENERAL GUIDELINES
ꢀ
WARNING
SECTION 1 - GENERAL GUIDELINES contains important information for
the safe operation and use of this product.
If oxygen is used in conjunction with a PAP machine and the full face mask,
the oxygen flow MUST be turned Off when the PAP machine is not
operating. If the oxygen flow is left On, oxygen may accumulate within the
tubing, machine enclosure, or the mask surroundings. Accumulated
oxygen in the tubing, machine enclosure, or the mask surroundings may
increase the risk of fire.
CAUTION
“Caution: Federal law restricts this device to sale or rental by or on order of a
physician, or any other practitioner licensed by the law of the state in which
he/she practices to use or order the use of this device.”
At low CPAP pressures the flow through the exhalation port may be inadequate
to clear all exhaled gas from the tubing. Some rebreathing may occur.
This Twilight Full Face Mask should be used only with PAP systems
recommended by your physician or respiratory therapist. A mask should not be
used unless the PAP system is turned On and operating properly.
This mask is a full face mask, which covers both the nose and the mouth.
NEVER block the vent hole or holes associated with the mask.
DO NOT use an electrically conductive breathing tube.
PAP systems are intended to be used with special masks which have vent holes
to allow continuous flow of air out of the mask. When the PAP machine is
turned On and functioning properly, new air from the PAP machine flushes the
exhaled air out through the mask exhalation vent holes. However, when the
PAP machine is not operating, not enough fresh air is provided through the
mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer
than several minutes can in some circumstances lead to suffocation. This
warning applies to most models of PAP systems.
The mask may not be suitable for those with risk of gastric regurgitation or
similar conditions.
For patients who are unable to remove the mask, it MUST be used under
qualified supervision.
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 systems.
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SECTION 2—USING THE MASK ASSEMBLY
SECTION 2—USING THE MASK ASSEMBLY
Assembling the Cushion
NOTE: For this procedure, refer to SECTION A in supplemental sheet provided.
1. Remove the cushion from the plastic bag and install onto the mask
frame.
2. Align the keying features at the bottom and sides of the cushion to the
mating keying features on the mask frame.
3. Gently push the cushion ribbing down into the mounting channel on
the mask frame.
NOTE: The cushion is completely seated in the mounting channel when the
cushion and the mask frame meet forming a gapless seam around the outside edge.
Inspecting the Mask
NOTE: For this procedure, refer to SECTION B in supplemental sheet provided.
NOTE: Wash the headgear before using it for the first time, as dye may run. Refer
NOTE: Invacare recommends washing your face before fitting the mask. This will
remove excess facial oil and extend the life of the mask.
Check the following:
•
•
•
•
•
•
Check that the valve flap is clean and dry.
Inspect the valve flap for any damage or wear.
Ensure that the valve flap is mounted to the mask swivel.
Ensure that the mask and tubing swivels rotate properly.
Ensure the port is plugged.
Ensure the exhalation vent holes are clear.
Check Valve Function
ꢀ WARNING
DO NOT use the mask if the valve flap is damaged or missing.
NOTE: If the valve flap is damaged, distorted, or torn, it should be replaced with
a new part.
NOTE: For this procedure, refer to SECTION C in supplemental sheet provided.
1. Connect a standard 22mm bore, 6-foot tube from your flow generator
to the hose swivel by pressing the tube end over the swivel.
2. Turn On the flow generator.
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SECTION 2—FITTING THE MASK
3. Check that the valve functions properly by sealing off the cushion
facial opening. The valve flap should cover and seal the large opening
in the mask swivel.
4. Turn the flow generator Off. The flap should return to a straight
position and not be blocking the large opening in the mask swivel.
ꢀ WARNING
DO NOT place the mask on your face unless the PAP machine is
turned On. Otherwise, injury may occur.
Fitting the Mask
NOTE: For this procedure, refer to SECTION D in the supplemental sheet.
1. Before fitting the mask, unfasten one or both of the headgear clips
from the mask frame (D-1).
2. Place the mask on the face with the headgear straps behind the head
(D-2).
3. Fit the mask loosely over the nose and mouth with minimal pressure.
4. Reattach both headgear clips to the mask frame (D-2).
5. Adjust the mask as follows:
A. Lift the forehead lever to the unlocked position (D-3).
B. Slide the forehead support up or down until it contacts the
forehead and the upper portion of the cushion lightly touches the
bridge of the nose (D-3).
C. Lower the forehead lever to lock the forehead support in the
desired position (D-4).
ꢀ WARNING
DO NOT pull the straps too tight. This can cause skin irritation and
may deform the cushion causing a leak. If the mask and headgear are
adjusted correctly and a problem persists, contact your health care
professional.
6. Adjust the strap length as needed using the hook and loop fasteners
(D-5 and D-6).
NOTE: If a leak occurs, adjust the forehead support. If this does not work, tighten
or loosen the headgear straps by readjusting the hook-and-loop fasteners.
NOTE: Proper mask fit should allow full contact of the cushion without excessive
pressure on the face.
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SECTION 2—REMOVING THE MASK AND HEADGEAR
Removing the Mask and Headgear
NOTE: For this procedure, refer to SECTION D in the supplemental sheet
provided.
1. Place your thumb and forefinger around one of the headgear clips
(D-1).
2. Gently pull the headgear clip away from your face.
NOTE: It is not necessary to remove the headgear straps from the clips or the
forehead support when removing the mask.
3. Pull the mask forward and lift it upwards and over the head.
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SECTION 3—CLEANING THE MASK
SECTION 3—CLEANING THE MASK
Disassembling the Mask for Cleaning
NOTE: For this procedure, refer to SECTION B, SECTION C, SECTION E, and
SECTION F on supplemental sheet.
1. Detach the headgear from the forehead support by unfastening the
hook-and-loop fastener tabs from the headgear and sliding the straps
out of the slot in the forehead support (SECTION C).
NOTE: It is not necessary to detach the clips from the headgear for daily washing
unless desired.
NOTE: It is not necessary to completely disassemble the mask for daily cleaning
in the home. The mask can be cleaned and rinsed while still assembled. It is
recommended to disassemble the mask for cleaning at least once per week.
2. Lift the forehead lever to the unlocked position (E-2).
3. Rotate the forehead support and remove from mask frame (E-3).
4. Rotate the forehead lever outward and remove from the mask frame
(E-4).
NOTE: It is not necessary to remove the forehead support after every use. It can
be cleaned and rinsed while it is mounted to the mask frame.
5. Remove the cushion from the mask frame by slowly pulling the
cushion off (SECTION B).
6. Remove the retaining ring on the outside of the mask swivel (F-1).
7. Remove the mask swivel by rotating it back through the opening in
the mask frame (F-2).
8. Remove the hose swivel by pulling it off the mask swivel (F-3).
9. Gently remove the valve flap by pulling it out of the mask swivel (F-3).
10. Uncover the port by grabbing the tab on the port plug and gently
pulling up (F-4).
11. Remove the port plug from the mask frame by holding it near the
attachment point and gently pulling it straight out (F-4).
NOTE: Placing the components in the wash solution first can ease in the removal
of the port plug from the mask frame.
NOTE: It is not necessary to remove the valve flap and the port plug completely
after every use. They can be cleaned and rinsed while attached to the mask frame.
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SECTION 3—CLEANING THE MASK AND HEADGEAR
Cleaning the Mask and Headgear
CAUTION
ALWAYS be sure to remove any foreign material (dirt, lint, etc.)
from the exhalation vents.
DO NOT use bleach, chlorine, aromatic-based cleaning solutions,
scented oils, or moisturizing or antibacterial soaps to clean the mask
components. These solutions may cause hardening and reduce the life
of the product.
Alcohol may be used to clean the silicone cushion ONLY. DO NOT
use alcohol to clean the mask frame, headgear or air tubing.
ꢀ WARNING
DO NOT expose any part of the mask system or tubing to direct
sunlight as it may cause mask deterioration.
ALWAYS rinse mask thoroughly after cleaning. Insufficient rinsing of
cleaning agents can result in severe skin rash, irritation and skin
breakdown. Discontinue using the mask if there is an allergic reaction
to any part of the mask, and contact your healthcare professional.
Washing the mask in an automatic dishwasher is not recommended.
Doing so may damage or affect the life of the valve flap or the
product. Also, the automatic dishwasher cleaning and rinsing agents
may leave a residue on the mask, which may cause skin irritation.
For multi-patient use/reuse, clinicians should refer to the Mask
Disinfection and Sterilization Guide (p/n 1130216).
The headgear cannot be disinfected or sterilized. Refer to instruc-
tions below for washing the headgear.
NOTE: Wash the entire mask system (except the headgear) after each use.
NOTE: Wash the headgear at least once per week.
NOTE: ALWAYS hand wash the headgear to increase the life of the product.
2. Hand wash the headgear in warm or cool water using a mild
detergent.
3. Rinse the headgear thoroughly and allow to air dry.
4. Hand wash the mask components using a mild detergent, such as
hand dishwashing detergent, in warm water.
5. Rinse the mask components thoroughly and allow them to air dry.
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SECTION 3—ASSEMBLING THE MASK
Assembling the Mask
CAUTION
Replace the mask or mask component if damaged or deteriorated.
Dispose of any damaged or broken parts in an environmentally
friendly manner or as normal household waste.
ꢀ WARNING
DO NOT use the mask if the valve flap is damaged or missing.
NOTE: For this procedure, refer to SECTION A, SECTION C, SECTION E, and
SECTION F on supplemental sheet provided.
1. Inspect all components for damage or wear.
2. Replace the port plug onto the mask frame by pushing the barb on the
port plug into the hole in the mask frame while gently pulling the barb
through from the other side until the barb snaps into place (F-4).
3. Push the port plug down over the port on the mask frame to seal the
port (F-4).
4. Check that the valve flap is clean and dry (F-3).
5. Slide the valve flap into the slot in the mask swivel. Gently pull it
through from the inside while pushing it in from the outside until it
snaps into place (F-3).
6. Snap the hose swivel onto the mask swivel (F-3).
7. Insert the mask swivel through the opening in the mask frame from
the inside (F-2).
8. Lock the mask swivel into place on the outside of the mask frame by
slipping the retaining ring over the mask swivel (F-2).
9. Push the retaining ring into the groove on the swivel until it snaps in
place (F-1).
NOTE: Align the keying features at the bottom and sides of the cushion to
the mating keying features on the mask frame (SECTION A).
10. Gently push the cushion ribbing down into the mounting channel on
the mask frame.
NOTE: The cushion is completely seated in the mounting channel when the
cushion and the mask frame meet forming a gapless seam around the outside edge.
11. If necessary, reattach the forehead support as follows:
A. Slide the forehead lever onto the mask frame (E-4).
B. Position the forehead lever into the unlocked position (E-3).
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WARRANTY
C. Slide the forehead support into the mask frame and place at
desired position (E-2).
D. Lower the forehead lever to lock the forehead support in the
desired position (E-1).
12. Attach the headgear to the mask by sliding the upper headgear straps
through the loophole of the forehead support. The tan side of the
headgear goes against the head and the Invacare label will be on the
outside of the upper strap (SECTION C).
13. Loosely secure each side of the upper headgear strap by folding them
back and using the hook-and-loop fastening strips to secure the ends
of the straps to the upper headgear strap (SECTION C).
14. Slide the lower headgear strap through the loopholes of the headgear
clips (SECTION C).
15. Loosely secure each side of the lower headgear strap by folding them
back and using the hook-and-loop fastening strips to secure the ends
of the straps to the lower headgear strap (SECTION C).
WARRANTY
PLEASE NOTE: THE WARRANTY BELOW HAS BEEN DRAFTED TO COMPLY
WITH FEDERAL LAW APPLICABLE TO PRODUCTS MANUFACTURED AFTER
JULY 4, 1975.
This warranty is extended only to the original purchaser/user of our products.
This warranty gives you specific legal rights and you may also have other legal rights
which vary from state to state.
Invacare warrants the Twilight Full Face Mask to be free from defects in materials and
workmanship for a period of 90 days from date of purchase. If within such warranty
period any such product shall be proven to be defective, such product shall be repaired or
replaced, at Invacare's option. This warranty does not include any labor or shipping
charges incurred in replacement part installation or repair of any such product.
Invacare's sole obligation and your exclusive remedy under this warranty shall be limited
to such repair and/or replacement.
For warranty service, please contact the dealer from whom you purchased your Invacare
product. In the event you do not receive satisfactory warranty service, please write
directly to Invacare at the address on the back cover, provide dealer's name, address,
date of purchase, indicate nature of the defect and, if the product is serialized, indicate
the serial number. Do not return products to our factory without our prior consent.
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LIMITATIONS AND EXCLUSIONS: THE FOREGOING WARRANTY SHALL NOT
APPLY TO SERIAL NUMBERED PRODUCTS IF THE SERIAL NUMBER HAS BEEN
REMOVED OR DEFACED, PRODUCTS SUBJECTED TO NEGLIGENCE, ACCIDENT,
IMPROPER OPERATION, MAINTENANCE OR STORAGE, COMMERCIAL OR
INSTITUTIONAL USE, PRODUCTS MODIFIED WITHOUT INVACARE'S EXPRESS
WRITTEN CONSENT (INCLUDING, BUT NOT LIMITED TO,
MODIFICATION THROUGH THE USE OF UNAUTHORIZED PARTS OR
ATTACHMENTS; PRODUCTS DAMAGED BY REASON OF REPAIRS MADE TO ANY
COMPONENT WITHOUT THE SPECIFIC CONSENT OF INVACARE, OR TO A
PRODUCT DAMAGED BY CIRCUMSTANCES BEYOND INVACARE'S CONTROL,
AND SUCH EVALUATION WILL BE SOLELY DETERMINED BY INVACARE. THE
WARRANTY SHALL NOT APPLY TO PROBLEMS ARISING FROM NORMAL WEAR
OR FAILURE TO ADHERE TO THE FOLLOWING INSTRUCTIONS.
THE FOREGOING EXPRESS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY
OTHER WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED,
INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE, AND THE SOLE REMEDY FOR VIOLATIONS OF
ANY WARRANTY WHATSOEVER, SHALL BE LIMITED TO REPAIR OR
REPLACEMENT OF THE DEFECTIVE PRODUCT PURSUANT TO THE TERMS
CONTAINED HEREIN. THE APPLICATION OF ANY IMPLIED WARRANTY
WHATSOEVER SHALL NOT EXTEND BEYOND THE DURATION OF THE EXPRESS
WARRANTY PROVIDED HEREIN. THE MANUFACTURER SHALL NOT BE LIABLE
FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER.
THIS WARRANTY SHALL BE EXTENDED TO COMPLY WITH STATE/PROVINCIAL
LAWS AND REQUIREMENTS.
Invacare Corporation
USA
Manufactured by:
Invacare Corp.
One Invacare Way
Elyria, Ohio USA
44036-2125
2101 E. Lake Mary Blvd.
Sanford, FL 32773
800-832-4707
800-333-6900
Technical Services
800-832-4707
All rights reserved. Trademarks are
identified by ™ and ®.
All trademarks are owned by or
licensed to Invacare Corporation
unless otherwise noted.
R
© 2007 Invacare Corporation
Part No 1130237
Rev A - 9/07
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