Invacare Oxygen Equipment 1126360 3 User Manual

Assembly, Installation, and Operating  
Instructions  
®
Invacare Twilight™II  
Nasal Mask  
LATEX  
FREE  
USER: Before using this nasal mask, read this manual and save  
for future reference.  
DEALER: This manual must be given to the end user.  
For more information regarding  
Invacare products, parts, and services,  
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SPECIAL NOTES  
WARNING  
DO NOT install, maintain or operate this equipment  
without first reading and understanding this manual. If  
you are unable to understand the DANGERS/  
WARNINGS/CAUTIONS and INSTRUCTIONS, contact  
your Home Healthcare provider before attempting to use  
this equipment - otherwise injury or damage may result.  
Invacare products are specifically designed and  
manufactured for use in conjunction with Invacare  
accessories. Accessories designed by other manufacturers  
have not been tested by Invacare and are not  
recommended for use with Invacare products.  
Part No 1126360  
3
Invacare® Twilight™II Nasal Mask  
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GENERAL GUIDELINES  
GENERAL GUIDELINES  
WARNING  
GENERAL GUIDELINES contains important information  
for the safe operation and use of this product. DO NOT  
use this product or any available optional equipment  
without first completely reading and understanding these  
instructions and any additional instructional material such  
as Owner’s Manuals, Service Manuals or Instruction  
Sheets supplied with this product or optional equipment.  
If you are unable to understand the Warnings, Cautions  
or Instructions, contact a health care professional, dealer  
or technical personnel before attempting to use this  
equipment - otherwise, injury or damage may occur.  
This Twilight II Nasal Mask should be used only with CPAP  
systems recommended by your physician or respiratory  
therapist. A mask should not be used unless the CPAP system  
is turned on and operating properly.  
NEVER block the vent holes associated with the mask.  
CPAP 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 CPAP machine is turned on and functioning  
properly, new air from the CPAP machine flushes the exhaled  
air out through the mask exhalation vent holes. However, when  
the CPAP 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 CPAP systems.  
CAUTION  
Federal law restricts this device to sale by or on the order  
of a physician.  
Invacare® Twilight™II Nasal Mask  
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Part No 1126360  
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USING HEADGEAR/MASK ASSEMBLY  
Using Headgear/Mask Assembly  
NOTE: For this procedure, refer to FIGURE 1 on page 7 and  
FIGURE 2 on page 8.  
NOTE: Wash the headgear before using it for the first time, as dye  
may run. Refer to Cleaning the Mask and Headgear on page 9.  
NOTE: Invacare recommends washing your face before each use of  
the mask. This will remove excess facial oil and extend the life of the  
mask.  
NOTE: Twilight II Nasal Mask is supplied fully assembled.  
1. Remove the clear protective cover that is over the cushion.  
2. Check for the following:  
A. Ensure that the nasal cushion is fully attached.  
B. Ensure the mask and hose swivels rotate properly.  
C. Ensure the port plug is fully seated to seal the port, and  
the exhalation vent holes are clear.  
3. Unfasten one or both of the headgear clips from the mask  
shell. Refer to FIGURE 2 on page 8.  
4. Connect a standard 22 mm bore, 6-foot hose from your  
flow generator to the hose swivel by pressing the tube end  
over the hose swivel.  
5. Turn on the flow generator.  
WARNING  
Flow generator MUST be on BEFORE placing the mask  
on your face.  
6. Place the mask on your face with the headgear straps  
behind your head.  
7. Fit the mask loosely over your nose and mouth.  
NOTE: A minimal amount of pressure should be used to secure the  
nasal mask to the face.  
Part No 1126360  
5
Invacare® Twilight™II Nasal Mask  
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USING HEADGEAR/MASK ASSEMBLY  
8. Adjust the mask position on the nose by doing the  
following:  
A. Press the forehead support adjustment tab.  
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.  
C. Release the adjustment tab to lock it in the desired  
position.  
9. Attach the headgear clips to the mask, and adjust the strap  
lengths as needed.  
NOTE: Proper mask fit should allow full contact of the cushion  
without excessive pressure on the face.  
NOTE: If a leak occurs, tighten or loosen the headgear straps by  
readjusting the hook-and-loop fastening strips.  
WARNING  
DO NOT pull the straps too tight; this can cause skin  
irritation and may deform the nasal cushion, causing a  
leak. If the mask and headgear are adjusted correctly and  
a problem persists, contact your health care professional.  
Invacare® Twilight™II Nasal Mask  
6
Part No 1126360  
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USING HEADGEAR/MASK ASSEMBLY  
DETAIL “A” - MASK  
Forehead Support  
Loophole  
Nasal  
Cushion  
Forehead Support  
Adjustment Tab  
Swivel  
Retaining Ring  
Port Plug  
Mask Frame  
Hose Swivel  
Mask Swivel  
Exhalation  
Vents  
DETAIL “B” - HEADGEAR  
Upper Headgear Strap  
(tan side in)  
DETAIL “C” - FITTING  
Hook and  
Loop Fastener  
Straps  
Headgear  
Lower Headgear  
Attach Hose from Flow  
Generator Here  
Clips  
Strap  
FIGURE 1 Using Headgear/Mask Assembly  
Part No 1126360  
7
Invacare® Twilight™II Nasal Mask  
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REMOVING THE MASK AND HEADGEAR  
Removing the Mask and Headgear  
NOTE: For this procedure, refer to FIGURE 2.  
1. Place your thumb and forefinger around one of the  
headgear clips.  
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.  
Lower Headgear  
Lower  
Strap  
Headgear  
Strap  
Headgear Clip  
Headgear Clip  
FIGURE 2 Removing the Mask and Headgear  
Invacare® Twilight™II Nasal Mask  
8
Part No 1126360  
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CLEANING THE MASK AND HEADGEAR  
Cleaning the Mask and Headgear  
WARNING  
DO NOT expose any part of the mask system to direct  
sunlight as it may cause mask deterioration.  
After cleaning, ALWAYS rinse mask thoroughly.  
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 health care professional.  
For multi-patient use/reuse, clinicians should refer to the  
Mask Disinfection and Sterilization Guide (p/n 1130216).  
The Twilight II Headgear cannot be disinfected or  
sterilized. Refer to instructions below for washing the  
headgear.  
CAUTION  
ALWAYS be sure to remove any foreign material (dirt,  
lint, etc.) from the exhalation vent holes.  
DO NOT use bleach, chlorine, aromatic-based cleaning  
solutions, scented oils, or moisturizing or antibacterial  
soaps, to clean the nasal cushion, mask frame, headgear  
or air hose. These solutions may cause hardening and  
reduce the life of the product.  
Alcohol may be used to clean the silicone nasal cushion  
ONLY. DO NOT use alcohol to clean the mask frame,  
headgear or air hose.  
NOTE: Wash the 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.  
Part  
No  
1126360  
9Inva®caTrweilight™II Nasal Mask  
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DISASSEMBLING THE MASK FOR CLEANING  
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, though, that the mask be  
disassembled for cleaning at least once per week of use.  
1. Disassemble the mask. Refer to Disassembling the Mask  
for Cleaning on page 10.  
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 dishwashing detergent, in warm water.  
5. Rinse the mask components thoroughly and allow them to  
air dry.  
WARNING  
Washing the mask in a dishwasher is not recommended.  
Dishwasher cleaning and rinsing agents may leave a  
residue on the mask, which may cause skin irritation.  
DO NOT air dry in direct sunlight as it may cause mask  
deterioration.  
Disassembling the Mask for Cleaning  
NOTE: For this procedure, refer to FIGURE 1 on page 7 and  
FIGURE 3 on page 12.  
1. Removing the mask. Refer to Removing the Mask and  
Headgear on page 8  
2. Detach the six foot air hose from the hose swivel.  
3. 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 slots in the  
forehead support (Detail “B” of FIGURE 1).  
Invacare® Twilight™II Nasal Mask  
10  
Part No 1126360  
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DISASSEMBLING THE MASK FOR CLEANING  
4. Remove the forehead support from the mask frame by  
pressing down the adjustment tab and sliding the support  
upward over the tab and off of the frame (Detail A” of  
FIGURE 3).  
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 shell.  
5. Remove the nasal cushion from the mask frame by slowly  
pulling it out of the mounting channel.  
6. Remove the swivel retaining ring on the outside of the  
mask swivel (Detail “B” of FIGURE 3).  
7. Remove the mask swivel by rotating it through the  
opening in the mask frame.  
8. Remove the hose swivel by pulling it off of the mask  
swivel.  
9. Gently pull the port plug off the port on the mask swivel.  
10. Remove the port plug from the mask swivel by holding it  
near the attachment point and gently pulling it straight out.  
NOTE: Placing the components in the wash solution first can ease  
in the removal of the port plug from the mask swivel.  
NOTE: It is not necessary to remove the plug completely from the  
mask swivel after every use. It can be cleaned and rinsed while it is  
attached to the mask frame.  
Part No 1126360  
11  
Invacare® Twilight™II Nasal Mask  
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REASSEMBLING THE MASK  
DETAIL “A” - CUSHION  
AND FOREHEAD SUPPORT  
DETAIL “B” - FRAME, RING,  
AND SWIVELS  
Port Plug  
Forehead  
Support  
Port  
Swivel  
Retaining  
Ring  
Hose Swivel  
Adjustment  
Mounting  
Tab  
Channel  
Nasal  
Cushion  
Mask  
Frame  
Mask  
Swivel  
Mask  
Frame  
Hose Swivel  
FIGURE 3 Cleaning the Mask and Headgear  
Reassembling the Mask  
WARNING  
Replace the mask or mask component if damaged or  
deteriorated.  
NOTE: For this procedure, refer to FIGURE 3 on page 12 and  
FIGURE 4 on page 15.  
1. Replace the port plug onto the mask swivel by pushing the  
barb on the plug into the hole in the swivel while gently  
pulling the barb through from the other side, until the barb  
snaps into place (Detail “B” of FIGURE 3).  
2. Push the port plug down over the port on the mask swivel  
to seal the port.  
3. Snap the hose swivel onto the mask swivel.  
4. Insert the mask swivel through the opening in the mask  
frame from the inside.  
Invacare® Twilight™II Nasal Mask  
12  
Part No 1126360  
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REASSEMBLING THE MASK  
5. Lock the mask swivel into place on the outside of the mask  
frame by slipping the swivel retaining ring over the  
swivel.  
6. Seat the swivel retaining ring into the groove on the swivel  
until it snaps in place.  
7. Align the keying features at the top and bottom of the  
nasal cushion to the mating keying features in the  
mounting channel of the mask frame. The textured area  
above the keying feature at the top of the cushion aligns  
with the base of the adjustment tab. (Detail “B” of FIGURE  
4).  
8. Gently push the cushion ribbing down into the mounting  
channel on the mask frame.  
NOTE: The nasal cushion is completely seated in the mounting  
channel when the cushion and the mask frame meet forming a  
gapless seam around the outside edge.  
9. If necessary, reattach the forehead support by doing the  
following (Detail “B” of FIGURE 4):  
A. Align the channels on the outside of the support with  
the flanges on the mask frame.  
B. Slide the forehead support into the top of the mask  
frame.  
C. Press the forehead support adjustment tab.  
D. Slide the end of the forehead support over the tab to the  
desired position.  
E. Release the adjustment tab to lock it in the desired  
position.  
10. Attach the headgear to the mask by sliding the upper  
headgear strap 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.  
Part No 1126360  
13  
Invacare® Twilight™II Nasal Mask  
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REASSEMBLING THE MASK  
11. Loosely secure each side of the upper headgear strap by  
folding it back and, using the hook-and-loop fastening  
strips, secure the excess straps to the upper headgear strap.  
12. Slide the lower headgear strap through the loopholes of  
the headgear clips.  
13. Loosely secure each side of the lower headgear strap by  
folding it back and, using the hook-and-loop fastening  
strips, secure the excess straps to the lower headgear strap.  
Invacare® Twilight™II Nasal Mask  
14  
Part No 1126360  
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REASSEMBLING THE MASK  
DETAIL “A” - FRONT  
Forehead Support  
Adjustment  
Tab  
Swivel  
Retaining  
Ring  
Port  
Plug  
INSIDE  
OUTSIDE  
Mask  
Swivel  
Nasal Mask  
Cushion  
Hose Swivel  
Mask Frame  
Channels  
DETAIL “B” - REAR  
OUTSIDE  
Adjustment Tab  
Forehead  
Support  
Mating Keying  
Feature  
Mounting Channel  
Keying  
Feature  
Textured area  
Mask  
Frame  
Flanges  
INSIDE  
Nasal  
Cushion  
Cushion Ribbing  
FIGURE 4 Cleaning the Mask and Headgear  
Part No 1126360  
15  
Invacare® Twilight™II Nasal Mask  
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STORAGE AND OPERATING CONDITIONS  
Storage and Operating Conditions  
OPERATING TEMPERATURE:  
STORAGE TEMPERATURE:  
50 to 104°F (10 to 40°C)  
- 4 to 158°F (-20 to 70°C)  
MASK DEADSPACE VOLUME (ml)  
Small  
85  
Standard  
102  
Large  
108  
Typical values for Pressure Drop  
0.12 cmH O (.012 kPa) at flow of 50 LPM  
2
0.41 cmH O (.040 kPa) at flow of 100 LPM  
2
Pressure and Flow Characteristic  
EXHAUST VENT PRESSURE AND FLOW  
60  
50  
40  
30  
20  
10  
0
0
10  
15  
20  
25  
5
Pressure (cmH20)  
Invacare® Twilight™II Nasal Mask  
16  
Part No 1126360  
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REPLACEMENT ITEMS/ACCESSORIES  
Replacement Items/Accessories  
The following Invacare Twilight II Mask replacement items  
and accessories are available:  
• Small Nasal Cushion - ISP2110SM  
• Standard Nasal Cushion - ISP2110STD  
• Large Nasal Cushion - ISP2110L  
• Headgear - 1122733  
• Chin Support - 1122734  
Part No 1126360  
17  
Invacare® Twilight™II Nasal Mask  
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NOTES  
Invacare® Twilight™II Nasal Mask  
18  
Part No 1126360  
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WARRANTY  
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 II 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.  
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.  
®
Part  
No  
1126360  
19InvacaTrewilight™II Nasal Mask  
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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  
Invacare, Yes, you can. and the  
Medallion Design are registered  
trademarks of Invacare Corporation.  
Twilight is a trademark of Invacare  
Corporation.  
One Invacare Way  
Elyria, Ohio USA  
44036-2125  
800-333-6900  
© 2006 Invacare Corporation  
Part No 1126360  
Rev D - 9/1/06  
Tech Services  
800-832-4707  
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