Invacare Sleep Apnea Machine ISP2000 Assembly, Installation And Operating Instructions

ASSEMBLY, INSTALLATION, AND
OPERATING INSTRUCTIONS
Invacare® Twilight™
Nasal Mask and Headgear
MODEL NO: ISP2000 STANDARD
LATEX
FREE
DEALER: THIS MANUAL MUST BE GIVEN TO THE END USER.
USER: BEFORE USING THIS NASAL MASK AND HEADGEAR, READ THIS
MANUAL AND SAVE FOR FUTURE REFERENCE.
For more information regarding
Invacare products, parts, and services,
please visit: www.invacare.com
1
SPECIAL NOTES
SPECIAL NOTES
DANGER/WARNING/CAUTION notices as used in this manual
apply to hazards or unsafe practices which could result in personal
injury or property damage.
NOTICE
THE INFORMATION CONTAINED IN THIS DOCUMENT IS
SUBJECT TO CHANGE WITHOUT NOTICE.
CHECK ALL PARTS FOR SHIPPING DAMAGE. IF SHIPPING
DAMAGE IS NOTED, DO NOT USE. CONTACT DEALER/CARRIER
FOR FURTHER INSTRUCTION.
THE INVACARE TWILIGHT NASAL MASK IS INTENDED TO BE
USED WITH POSITIVE AIRWAY PRESSURE DEVICES SUCH AS
CPAP, TO PROVIDE 3-20 cmH2O FOR THE TREATMENT OF
ADULT OBSTRUCTIVE SLEEP APNEA. THE MASK IS INTENDED
FOR SINGLE PATIENT USE. THE MASK IS TO BE USED ON
ADULT PATIENTS (> 66 LBS [30 kg]) FOR WHOM POSITIVE
AIRWAY PRESSURE THERAPY HAS BEEN PRESCRIBED.
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.
2
SPECIAL NOTES
SAFETY SUMMARY
To ensure the safe and proper installation and use of the
Invacare Twilight Nasal Mask and Headgear, these
instructions MUST be followed:
WARNING
This Twilight 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 hole or holes associated with
the mask.
Explanation of Warning: CPAP systems are intended
to be used with special masks with connectors 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 attached mask
exhalation port. 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.
The entire mask system is for single patient use, and
must not be reused on another person. This is to avoid
risk of cross-infection.
3
HEADGEAR/MASK ASSEMBLY, PLACEMENT
HEADGEAR/MASK ASSEMBLY, PLACEMENT
AND USAGE (FIGURE 1)
NOTE: Wash the headgear before using it for the first time, as dye may
run. Refer to CLEANING THE MASK AND HEADGEAR in this manual.
NOTE: Invacare recommends washing your face before fitting the
mask. This will remove excess facial oil and extend the life of the mask.
1. Check the nasal mask, ensuring that the nasal cushion is attached,
the swivels function, and the exhalation ports are clear.
2. Attach the headgear to the nasal mask by sliding the upper
headgear straps through the loophole of the forehead support.
3. Adjust each strap by folding it back and attaching it to itself,
using the hook and loop fastener straps.
4. Slide the lower headgear strap through the loopholes of the
headgear clips.
5. Loosely secure the straps by folding them back and using the
hook and loop fastener straps.
6. Connect a standard 22mm bore, 6-foot tube from your flow
generator to the tubing swivel by pressing the tube end over
the swivel.
7. Turn ON the flow generator BEFORE placing the mask on
your face.
8. Place mask on face with headgear straps behind head.
9. Adjust the mask position on the nose. Depress the forehead
support adjustment tab and slide the forehead support up or
down until it contacts the forehead and the upper portion of the
nasal cushion lightly touches the bridge of the nose. The mask
should fit comfortably.
10. Place the mask loosely over the nose, with minimal pressure.
11. Attach the headgear clips to the nasal mask.
NOTE: If a leak occurs, tighten the headgear straps by readjusting the
hook and loop fasteners.
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 healthcare professional.
4
HEADGEAR/MASK ASSEMBLY, PLACEMENT
DETAIL “A”
Forehead
Support
Nasal
Cushion
Forehead Support
Adjustment Tab
NOTE: The Invacare
Twilight Nasal Mask is
supplied assembled
(except for the headgear
and headgear clips).
Main
Swivel
Tubing
Swivel
Mask Shell with
Exhalation Ports
DETAIL “C”
DETAIL “B”
Upper Headgear
Strap
Hook and Loop
Fastener Straps
Headgear
Clips
NOTE: Two (2) spare
clips are included.
Lower
Headgear
Strap
Attach Tube From
Flow Generator
Here
FIGURE 1 - HEADGEAR/MASK ASSEMBLY,
PLACEMENT AND USAGE
5
HEADGEAR/MASK REMOVAL, CLEANING
REMOVING THE MASK AND HEADGEAR
(FIGURE 2)
1. Place your thumb and forefinger around one of the headgear
clips and 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.
2. Pull the mask forward and lift it up and over the head.
Headgear
Clip
Headgear
Clip
FIGURE 2 - REMOVING THE MASK AND HEADGEAR
CLEANING THE MASK AND HEADGEAR
CAUTION
ALWAYS be sure to remove any foreign material (dirt,
lint, etc.) from the exhalation ports.
DO NOT use bleach, chlorine, aromatic-based cleaning
solutions, scented oils, or moisturizing or antibacterial soaps,
to clean the cushion, mask frame, headgear, or air tubing.
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, head gear or air tubing.
6
MASK REMOVAL, DISASSEMBLY AND CLEANING
WARNING
DO NOT expose any part of the mask system or tubing
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.
Wash the entire mask system (except the headgear) after each use.
Wash the headgear at least once per week.
NOTE: ALWAYS hand wash the headgear to increase the life of the
product.
1. Separate the headgear from the mask assembly and hand wash the
mask components using a mild detergent (such as dishwashing
detergent) in warm water. Rinse thoroughly and allow parts to
air-dry out of direct sunlight.
NOTE: It is not necessary to remove the nasal cushion after every use.
It can be cleaned and rinsed while it is mounted to the mask shell.
DISASSEMBLING/REASSEMBLING THE NASAL
CUSHION TO THE MASK SHELL (FIGURE 3)
1. Remove the nasal cushion by slowly pulling it out of the nasal
mask channel. Refer to FIGURE 3.
2. Hand wash the nasal cushion using a mild detergent (such as
dishwashing detergent) in warm water.
3. Prior to rinsing, press the ribbed portion of the nasal cushion
into the channel of the mask shell.
NOTE: Wetting the cushion ribbing sparingly with soapy water will ease
the insertion into the nasal channel.
4. Start with the top of the nasal mask cushion, gradually working
down the sides until the nasal mask cushion is seated in the
nasal mask channel.
7
REASSEMBLY
Nasal Mask
Channel
Nasal Mask
Cushion Ribbing
Nasal Mask
Cushion
Nasal Mask
Channel
Cushion Ribbing
FIGURE 3 - DISASSEMBLING/REASSEMBLING THE
NASAL CUSHION TO THE MASK SHELL
NOTE: Ensure the nasal cushion is COMPLETELY seated in the channel
before use. When properly assembled, the nasal cushion and mask shell
should form a smooth, continuous surface.
5. After the nasal mask cushion is securely reassembled, rinse the
entire mask thoroughly and allow to air dry out of direct sunlight.
NOTE: Make sure the mask is dry before use. Inspect the mask after
cleaning.
CAUTION
Replace the mask if any parts are damaged or
deteriorated.
8
STORAGE, SPECIFICATIONS
STORAGE AND OPERATING CONDITIONS
OPERATING TEMPERATURE:
50 to 104°F (10 to 40°C)
STORAGE TEMPERATURE:
-4 to 158°F (-20 to 70°C)
TYPICAL VALUES FOR PRESSURE DROP
0.30 cmH2O (.030 kPa) at flow of 50 LPM
1.14 cmH2O (.112 kPa) at flow of 100 LPM
PRESSURE AND FLOW CHARACTERISTICS
EXHAUST VENT PRESSURE VS. FLOW
60
50
Flow (LPM)
40
30
20
10
0
0
5
10
15
20
25
Pressure (cmH2O)
REPLACEMENT ITEMS/ ACCESSORIES
The following Invacare Twilight Mask replacement items and
accessories are available:
•
•
•
•
Standard nasal cushions - ISP2010
Large nasal cushions - ISP2010L
Headgear - 1122733
Chin Restraint - 1122734
9
WARRANTY
LIMITED 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 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.
10
WARRANTY
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.
11
Invacare Corporation
www.invacare.com
USA
One Invacare Way
Elyria, Ohio USA
44036-2125
800-333-6900
2101 E. Lake Mary Blvd.
Sanford, Florida USA
32773
Technical Support:
Toll Free 800-832-4707
Invacare is a registered trademark of
of Invacare Corporation.
Yes, you can. and Twilight are
trademarks of Invacare Corporation.
© 2003 Invacare Corporation
Part No. 1109361
Rev B - 10 /03