Inspire Medical Systems 2500 Patient Programmer for IPG User Manual 3032EN

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Document ID	2868960
Application ID	bHi3p5/QxEYy2bqC1SQnMA==
Document Description	User Manual Part 2
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Document Type	User Manual
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Date Submitted	2016-01-11 00:00:00
Date Available	2016-07-09 00:00:00
Creation Date	2015-10-30 08:52:13
Producing Software	Acrobat Distiller 11.0 (Windows)
Document Lastmod	2015-12-22 16:45:37
Document Title	3032EN.book
Document Creator	FrameMaker 11.0.2
Document Author:	Kathy

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Audio Tones
When audio tones are turned on, the sleep remote beeps
when a change to the therapy settings is successfully
completed.
Audio tone: Means:
• Your change was successful.
Two beeps
with a rising
tone
Three rapid
beeps
Six rapid
beeps
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• Your change was not successful, because the sleep
remote was unable to communicate with your
generator. Try the change again. (For instructions on
positioning your sleep remote, refer to page 24.)
• You tried to increase the stimulation strength outside
the range set by your doctor, and you have reached
the upper limit. (For instructions on increasing your
stimulation strength, refer to page 32.)
• You tried to decrease the stimulation strength outside
the range set by your doctor, and you have reached
the lower limit. (For instructions on decreasing your
stimulation strength, refer to page 33.)
• Communication with your generator was interrupted by
electromagnetic interference. Move away from
potential sources of interference, and try again.
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Turning Audio Tones On or Off
Your sleep remote audio tones can be turned on or off.
Inspire recommends that you keep audio tones on.
Turning audio tones on or off:
1. Remove the battery compartment cover. (For
instructions, refer to page 41.)
2. Push the audio tones switch up to turn the audio tones on
( ) and down to turn the audio tones off ( )
(Figure 10).
On
Audio tones
switch
Do not connect
anything to this
port
Off
Figure 10. Turning audio tones on or off
3. Replace the battery compartment cover. (For
instructions, refer to page 42.)
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Using Your Inspire Sleep Remote
Positioning Your Sleep Remote
The sleep remote communicates with your generator by
sending and receiving short range radio signals.
To communicate with your generator, you must place the
sleep remote Therapy On button (
) directly over your
generator immediately after you press a button (Figure 11).
The sleep remote attempts to communicate with your
generator for 10 seconds. If communication is not
successful after 10 seconds the sleep remote beeps rapidly
three times and the sleep remote light indicate the therapy
status for several seconds.
Sleep remote
Radio signals
Generator
Figure 11. Communication between sleep remote and generator
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To position your sleep remote for communication with
your generator:
1. Press a button. The therapy status light flashes to
indicate the change is in progress.
2. Position the sleep remote over your generator and
against your body. The buttons should face away from
your body (Figure 12).
Figure 12. Correct positioning of sleep remote over generator
3. Adjust the sleep remote position until the Therapy On
button (
) is directly over your generator.
4. Slowly adjust the sleep remote position until you hear a
tone or 10 seconds pass.
5. Remove the sleep remote from your body and review the
sleep remote lights to confirm that the change was
communicated to your generator.
Note: If you hear three rapid beeps, or the change you want
is not indicated by the sleep remote lights, then try
communicating with your generator again.
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If you are having trouble positioning the sleep remote:
Note: These steps turn therapy off.
1. Make sure the audio tones are on. (For instructions on
turning audio tones on and off, refer to page 23.)
2. Press the Therapy Off button ( ).
3. Position the sleep remote directly over your generator
and against your body. The buttons should face away
from your body (Figure 12).
4. Adjust the sleep remote position until the Therapy On
button (
) is directly over your generator.
5. Wait until you hear a tone or 10 seconds pass.
6. Remove the sleep remote from your body and review the
sleep remote lights to confirm that the change was
communicated to your generator.
Notes:
• If you hear three rapid beeps, or the change you want is
not indicated by the sleep remote lights, then try
communicating with your generator again.
• The sleep remote communicates one change at a time. If
you press an incorrect button, wait for 10 seconds until
the sleep remote stops attempting to communicate with
the generator, and then press the correct button.
• Pressing the Therapy Off button ( ) cancels
communication in progress. The sleep remote then
attempts to turn your generator off.
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Communicating with your Generator
When the sleep remote is communicating with your
generator, the status ring and stimulation strength gauge
blink on and off.
The blinking lights indicate the change the sleep remote is
attempting to make to your generator.
Status
ring
Figure 13. Status ring
Status ring:
Means:
Whole ring blinking white
Turning therapy off
Whole ring blinking green
Turning therapy on or pausing therapy
Top of ring blinking
Increasing stimulation strength
Bottom of ring blinking
Decreasing stimulation strength
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Stimulation
strength
gauge
Figure 14. Stimulation strength gauge
Stimulation strength
gauge:
Means:
Whole gauge blinking
white
Turning therapy off
Whole gauge blinking
green
Turning therapy on or pausing therapy
One step on the gauge is
blinking
Increasing or decreasing stimulation
strength. The newly selected stimulation
strength step is blinking.
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Turning Therapy On
It is recommended that you turn therapy on as part of your
bedtime routine. Immediately after turning therapy on, you
will feel a short stimulation. After that initial stimulation,
therapy is delayed so you have time to fall asleep.
To turn your therapy on:
1. Press the Therapy On button (
).
2. Position the sleep remote over your generator and
against your body with the buttons facing away from your
body (Figure 15).
Figure 15. Correct positioning of sleep remote over generator
3. Wait until you hear a tone or 10 seconds pass.
4. Check the status ring.
– If the status ring is solid green or is slowly dimming and
brightening green, therapy is on. The sleep remote
lights stay on for several seconds after communicating
with the generator.
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– If the sleep remote lights are off, gently shake the
remote and the lights turn on.
Note: When you turn stimulation on, you will feel one short
stimulation, and then your generator will delay further
stimulation while you fall asleep. Your doctor sets the length
of this Start Delay time for your generator.
Turning Therapy Off
Always turn therapy off when you are not sleeping. Leaving
therapy on reduces generator battery life and increases the
likelihood of unwanted stimulation.
To turn your therapy off:
1. Press the Therapy Off button ( ).
2. Position the sleep remote over your generator and
against your body with the buttons facing away from your
body (Figure 15).
3. Wait until you hear a tone or 10 seconds pass.
4. Check the status ring.
– If the status ring is a solid white, therapy is off. The light
stays on for several seconds after communicating with
the generator.
– If the sleep remote lights are off, gently shake the
remote and the lights will turn on.
Note: Pressing the Therapy Off button ( ) cancels
communication in progress. The sleep remote then attempts
to turn your generator off.
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Pausing Therapy
If you wake with your therapy on, and you intend to go back
to sleep, you can pause therapy instead of turning therapy
off. The length of time that the therapy pauses is set by your
doctor.
Therapy Pause and Start Delay are different. Start Delay
begins automatically when you turn therapy on. When
therapy is on, Therapy Pause begins when you press the
Therapy On button (
).
To pause therapy:
1. Press the Therapy On button (
).
2. Position the sleep remote directly over your generator
and against your body with the buttons facing away from
your body (Figure 15).
3. Wait until you hear a tone or 10 seconds pass.
4. Check the status ring.
– If the status ring is slowly dimming and brightening
green, therapy is paused. The status ring stays lit for
several seconds after communication with the
generator.
– If the sleep remote lights are off, gently shake the
remote and the lights will turn on.
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Increasing Stimulation Strength
The sleep remote allows you to increase stimulation
strength within a range set by your doctor. If you feel little or
no stimulation, you can increase ( ) the stimulation.
Stimulation can be increased when therapy is on or off.
The stimulation strength gauge on the back of the sleep
remote indicates the current stimulation strength and the
upper limit light ( ) indicates when you have reached the
highest stimulation strength allowed by your doctor. (For
information on the stimulation strength gauge and upper
limit, refer to page 18.)
Contact your doctor if you can’t achieve the desired
stimulation strength.
To test the current stimulation strength:
1. Turn therapy off by pressing the Therapy Off button ( )
and positioning the sleep remote over your generator.
2. Wait until you hear a tone or 10 seconds pass.
3. Turn therapy on by pressing the Therapy On button (
and positioning the sleep remote over your generator.
4. Wait until you hear a tone or 10 seconds pass.
5. You will receive one short stimulation immediately when
therapy is turned on.
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To increase stimulation strength:
1. Press the Increase button ( ).
Note: If the sleep remote beeps rapidly three times, and
the upper limit light ( ) on the back of the remote is on,
you have reached the upper limit.
2. Position the sleep remote directly over your generator
and against your body with the buttons facing away from
your body (Figure 15).
3. Wait until you hear a tone or 10 seconds pass.
4. To test the new stimulation strength:
a.Turn therapy off.
b.Turn therapy on. You will receive one short stimulation
immediately when therapy is turned on.
Decreasing Stimulation Strength
The sleep remote allows you to decrease the stimulation
strength within a range set by your doctor. If stimulation feels
too strong, you may want to decrease ( ) the stimulation
strength. Stimulation strength can be decreased with
therapy on or off.
The stimulation strength gauge on the back of the sleep
remote indicates the current stimulation strength. If only one
bar on the gauge is lit, then stimulation strength is at the
lowest allowed setting. (For information on the stimulation
strength gauge, refer to page 18.)
Contact your doctor if you can’t achieve the desired
stimulation strength.
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To test the current stimulation strength:
1. Turn therapy off by pressing the Therapy Off button ( )
and positioning the sleep remote over your generator.
2. Wait until you hear a tone or 10 seconds pass.
3. Turn therapy on by pressing the Therapy On button (
and positioning the sleep remote over your generator.
4. Wait until you hear a tone or 10 seconds pass.
5. You will receive one short stimulation immediately when
therapy is turned on.
To decrease stimulation strength:
1. Press the Decrease button ( ) to adjust your
stimulation strength.
Note: If the sleep remote beeps rapidly three times, and
only one bar on the stimulation strength gauge is on, you
have reached the lower limit.
2. Position the sleep remote directly over your generator
and against your body with the buttons facing away from
your body (Figure 15).
3. Wait until you hear a tone or 10 seconds pass.
4. To test the new stimulation strength:
a.Turn therapy off.
b.Turn therapy on. You will receive one short stimulation
immediately when therapy is turned on.
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5. Living with Your Inspire
System
Activities and Exercise
On the advice of your doctor, and as you begin to feel better
after your surgery, you can gradually resume your normal
lifestyle. Returning to your daily activities should make you
feel better, not worse. It is important that you follow your
doctor's advice. Ask your doctor about strenuous activities,
such as lifting heavy objects.
Caution: For several weeks after the implant procedure,
avoid sudden, excessive, or repetitive bending, twisting,
bouncing, or stretching. These types of activities could affect
your healing process and cause you discomfort.
Travel Information
As you travel, your sleep remote will allow you to operate
your generator at any travel destination while you sleep.
It is possible that airport security devices may affect the
operation of your generator and detect the metal in your
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generator. Always tell security staff that you have an
implanted generator and carry your Inspire Identification
Card for verification. This also applies if you encounter
similar security devices in other situations.
For detailed instructions about how to interact with security
devices, refer to "Theft Detector or Security Screening
Devices" on page 9.
When to Call Your Doctor
Call your doctor if:
• You experience anything unusual, such as new,
unexplained symptoms.
• You notice signs of infection such as redness and
swelling near an implant site.
• You notice that the stimulation begins to feel different or
becomes uncomfortable. Turn the therapy off first, then
call.
• You are not getting adequate stimulation.
• The location of your stimulation has dramatically
changed. This could result from movement of the
stimulation lead.
• The generator light on the back of your sleep remote is
on.
If you are unable to reach your doctor immediately, try
again at a later time. Meanwhile, discontinue therapy
and contact the doctor who implanted your system.
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Manufacturer's Information
Your primary resource for all questions and requests is your
doctor. As an additional resource, you may contact Inspire
Medical Systems, Inc:
Address: 9700 63rd Ave N, Maple Grove, MN 55369
Phone: 763-205-7970 or 1-844-672-4357 Toll Free
Website: www.inspiresleep.com
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6. Maintaining Your Inspire Sleep
Remote
You will need to replace your sleep remote batteries and
clean the sleep remote as needed. Although your doctor will
monitor your generator battery status during your follow-up
appointments, you can also use your sleep remote to check
your generator battery status.
Sleep Remote Batteries
Warning: The sleep remote batteries may pose a
choking hazard. Keep the sleep remote and batteries
away from children and pets.
The sleep remote uses two AAA or LR03 alkaline batteries.
Replace the batteries when the sleep remote battery light is
on or after 4 months of use.
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Cautions:
• Do not use rechargeable batteries in the sleep
remote. Rechargeable batteries may cause the sleep
remote to not function properly.
• Do not leave batteries in the sleep remote if it will not
be used for more than 4 weeks. Batteries left in the
sleep remote may corrode and damage the sleep
remote.
Checking the Sleep Remote Battery Status
Develop a routine where you check your sleep remote
battery status regularly. Inspire recommends checking the
sleep remote batteries each morning after you turn therapy
off.
To check the sleep remote battery status:
1. Pick up or gently shake the sleep remote.
2. Check the sleep remote battery light ( ) on the back of
your sleep remote
– If the light is on, replace the sleep remote batteries.
– If the light is off, the batteries are good.
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Replacing the Sleep Remote Batteries
The sleep remote batteries are located in a battery
compartment on the bottom of the sleep remote.
To remove the battery compartment cover:
1. Hold the sleep remote with the battery compartment
cover facing upwards as shown in Figure 16.
Figure 16. Removing the battery compartment cover
2. Push gently and firmly upward on the release tab at the
end of the sleep remote.
3. Gently rotate the cover upwards.
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To replace the sleep remote batteries:
1. Insert your finger in the finger hole to loosen the first
battery, and then gently remove the batteries.
2. Position each battery to match the figure in the battery
compartment (Figure 17).
Do not connect
anything to this
port
Finger hole
Figure 17. Battery compartment and battery placement
To close the battery compartment:
1. Insert the battery door tabs into the two slots located
above the batteries.
2. Gently lower the battery compartment cover.
3. Gently press down on the end of the battery
compartment cover to lock it in place.
4. Inspect the battery door to make sure it is properly
closed.
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Battery and Sleep Remote Disposal
Dispose of depleted batteries and a worn out sleep remote
according to local requirements. If desired, remove the
batteries and return the sleep remote to Inspire for disposal.
Cleaning Your Sleep Remote
Clean the outside of the sleep remote with a slightly damp
cloth. The sleep remote is not sterile and is not intended to
be sterilized. Diluted mild household detergents will not
damage the sleep remote.
Cautions:
• Avoid getting the sleep remote wet. Your sleep remote is
water-resistant, not waterproof, and exposure to water or
other liquids could damage the sleep remote.
• Do not use corrosive liquids to clean your sleep remote
(eg, bleach, nail polish remover). Corrosive liquids could
damage the external housing of the sleep remote.
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Handling Your Sleep Remote
The sleep remote should be handled with care.
Caution:
Handle your sleep remote with care. Mishandling the sleep
remote can damage the sleep remote.
• Do not drop the sleep remote. Protect the sleep remote
against sharp blows and physical shocks.
• Do not disassemble or tamper with the internal
components of the sleep remote. Accessing the internal
components could affect the performance of the sleep
remote and void the warranty.
Checking the Generator Battery Status
You can check your generator battery status. If your
generator battery is low, your generator will need to be
replaced.
To check the generator battery status:
1. Pick up or gently shake the sleep remote.
2. Check the generator light ( ) on the back of your sleep
remote. If the light is on, contact your doctor.
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7. Troubleshooting Your Sleep
Remote
The following table provides possible solutions to common
questions that may arise when using your sleep remote. If
you need further assistance in setting up, using, or
maintaining your sleep remote, or to report problems with
your sleep remote, contact your doctor or Inspire Medical
Systems, Inc. For contact information, refer to
“Manufacturer's Information” on page 37.
If this happens: Possible
causes:
Try these steps:
Yellow bars are
• A status light on • Turn the sleep remote over
flashing left and
on the back of
and view the status lights. For
right on the front
the sleep remote information on status lights,
of your sleep
is on.
refer to page 20.
remote.
A yellow light
or
) on the
back of your
sleep remote is
on.
• For information on status
lights, refer to page 20.
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If this happens: Possible
causes:
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Try these steps:
No lights turn on • Sunlight may
• If you are outdoors, move
after you press a
obscure your
indoors or use your sleep
button.
view of the sleep remote in the shade.
remote lights.
• No batteries,
• Check the orientation of the
depleted
batteries. If the batteries are
batteries, or a
oriented correctly, replace with
battery is placed new batteries (refer to
backwards in the page 39).
battery
• If the problem persists, call
compartment.
your doctor.
• Replace the sleep remote
Both status lights • The sleep
) on the
remote batteries batteries with new batteries.
back of the sleep
may be very low Make sure that you are not
remote are on,
and need to be
pressing any buttons while
and the sleep
replaced.
inserting batteries.
remote does not
work.
• The sleep
• For information on status
remote may not
lights, refer to page 20. If all
be operating
the lights stay on, call your
properly.
doctor.
You want to
check your
generator battery
without making
any other
changes.
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• Pick up or gently shake the
sleep remote to display the
battery status. If the generator
status light ( ) is off, your
generator battery is good
(refer to page 44).
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If this happens: Possible
causes:
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Try these steps:
You do not hear • Audio tones are • Turn audio tones on (refer to
audio tones, but
turned off.
page 23).
the sleep remote
is working.
You hear three
• The stimulation • Confirm that the current
beeps after
strength is at the stimulation strength does not
pressing the
upper or lower
work for you. Contact your
Increase ( ) or
limit.
doctor to change the
Decrease button
stimulation strength limits.
( ).
You hear three
beeps several
seconds after
pressing a
button.
Stimulation is
uncomfortable.
• A setting in your • Review current therapy
generator has
settings and try your change
changed.
again.
• Communication
with your
generator was
not successful.
1. Press the Therapy Off button
( ).
2. Reduce the stimulation
strength by pressing the
Decrease button ( ), and
then holding the sleep
remote over your generator.
3. Press the Therapy On button
( ) to test the stimulation
strength. Decrease
stimulation further if
necessary (refer to page 33).
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If this happens: Possible
causes:
Try these steps:
Stimulation is too
strong.
• Decrease stimulation (refer to
page 33).
Stimulation is not
strong enough.
• Increase stimulation (refer to
page 32).
You feel that a
• The sleep
• Hold the sleep remote closer
change took
remote was too
to your generator. Review the
place after you
far from the
positioning instructions on
pressed a button, generator. (The
page 24. Try your change
but the sleep
generator may
again.
remote lights did
have received
not change.
the sleep remote
signal, but the
sleep remote did
not receive the
generator
confirmation
signal.)
• An electronic
• Turn off or move away from
device interfered other electronic devices. Try
with
your change again.
communication
between your
sleep remote
and generator.
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If this happens: Possible
causes:
You do not feel
stimulation
immediately
when turning
therapy on.
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Try these steps:
• Therapy may not • Pick up or gently shake the
have turned on.
sleep remote to check therapy
status. If the status ring is
white, therapy is off. Turn
therapy on again.
• Your stimulation • Pick up or gently shake the
may be delayed
sleep remote to check therapy
or paused.
status. If the status ring is
slowly dimming and
brightening green, therapy is
on and stimulation is paused.
Stimulation will automatically
start after the Start Delay or
pause time.
• The stimulation • Pick up or gently shake the
strength may be sleep remote to check therapy
set too low.
status. If the status ring is solid
green, stimulation is on. You
may want to increase the
stimulation strength (refer to
page 32). If you still do not feel
stimulation, contact your
doctor.
• Your generator
may need
attention from
your doctor.
• Pick up or gently shake the
sleep remote. If the generator
status light ( ) on the back of
the sleep remote is on, contact
your doctor.
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If this happens: Possible
causes:
Your sleep
remote lights do
not turn on when
it is gently
shaken.
Your sleep
remote falls into
water.
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Try these steps:
Your sleep remote • Press the Therapy Off button
may have been
( ) and wait 10 seconds. If
excessively
the remote lights do not turn
bounced during
on, replace the remote
the previous 30
batteries (refer to page 39).
minutes and has
temporarily
disabled motion
sensing to save
battery life.
1. Immediately remove the
sleep remote from the water.
2. Dry the sleep remote with a
towel.
3. Remove the batteries and dry
the battery compartment if
needed.
4. Allow the battery
compartment to air dry at
room temperature for at least
24 hours.
5. Insert new batteries.
Your sleep
remote falls off a
cabinet or table.
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• The sleep remote is designed
to withstand a short drop and
still operate normally, even if
the case is chipped or
otherwise damaged.
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8. Specifications
If the sleep remote has been stored at high or low
temperatures, store the sleep remote at room temperature
for one hour before use. This will allow the remote to return
to normal operating temperature.
Inspire Sleep Remote
Power source
2 AAA or LR03 alkaline batteries
Operating temperature
5 – 40°C
41 – 104°F
Storage temperature
(inside or outside of packaging)
-25 – 70°C
-13 – 158°F
Operating humidity
15 – 90%
Storage humidity
up to 90%
Operating/storage atmospheric
pressure
700 hPa – 1060 hPa (20.7 Hg –
31.3 Hg)
Protection against electric shock Internally powered equipment
Battery life of sleep remote
batteries
2 months (average)
Expected service life of sleep
remote
5-year expected (minimum) life
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Connections to Additional Equipment
Anybody connecting additional equipment to medical
electrical equipment configures a medical system and is
responsible that the system complies with the requirements
for medical electrical systems.
Additional equipment connected to the sleep remote must
comply with the respective IEC or ISO standards (for
example IEC 60950 for data processing equipment such as
personal computers). All configurations must comply with
the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1,
respectively).
Local laws take priority over the requirements of this section.
Contact your doctor or Inspire for additional information.
Do Not Modify
Do not modify the sleep remote. Changes or modifications
could void the user's authority to operate the equipment.
FCC Statements
This equipment has been tested and found to comply with
the limits for a Class B digital device, pursuant to part 15 of
the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and
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used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no
guarantee that interference will not occur in a particular
installation.
If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and
receiver.
• Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician
for help.
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Inspire Medical Systems Limited Warranty
Summary
Inspire provides a limited warranty against defects. The warranty period
for implanted products is 3 years. All other products have a warranty
period of 1 year.
The warranty information below is intended for doctors (referred to as
physicians in the warranty), but is included here for reference. Ask your
doctor if you have any questions. The information below takes
precedence over the information contained in this Summary.
Inspire Medical Systems' products consist of Implantable Pulse
Generators (IPG), tools to connect the IPG to implantable leads, leads,
Inspire Sleep Remotes, and physician programmers.
1. EXCLUSION OF WARRANTIES, NO WARRANTIES FOR
TOOLS. The implied warranties of MERCHANTABILITY and
fitness for a particular purpose and all other warranties, express or
implied with regard to tools are EXCLUDED from any transaction
and shall not apply. Inspire Medical Systems will not be liable for
any damages, whether direct, consequential, or incidental caused
by tool defects, failures, or malfunctions, whether such claims are
based on warranty, contract, tort or otherwise. No person has any
authority to bind Inspire Medical Systems to any representation or
warranty with respect to tools. You may have other rights, which
vary from state to state. If one or more of the provisions of this
exclusion of warranties for tools shall be deemed void or
unenforceable, the remaining provisions shall continue to have full
force and effect.
2. LIMITED WARRANTY FOR PRODUCTS OTHER THAN TOOLS.
This limited warranty is available if products other than tools fail to
function within normal tolerances due to defects in materials or
workmanship that manifest during the specified warranty period.
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During the operational life of an IPG, battery energy is consumed to
monitor the patient's breathing and provide therapy. On the basis of
individual patient physiology, certain patients may require more frequent
therapy, thus requiring replacement of the IPG in less than the warranty
period shown below. This is considered normal for those patients and not
a malfunction or defect in the IPG.
If the purchaser complies with the Terms and Conditions, Inspire Medical
Systems will issue a limited warranty toward the purchase of a new
Inspire Medical Systems IPG product. The limited warranty credit amount
will be the full purchase price of either the original unit or the replacement
unit, whichever is less.
For patient products, for example, IPG, lead, Inspire Sleep Remote,
Inspire Medical Systems will issue a credit to the hospital conducting
replacement surgery on behalf of the original patient. Any cost
reductions extended as a result of this warranty shall be fully and
accurately reflected on the patients' bill and reported to that applicable
payor using the appropriate methodology.
For physician products, for example, physician programmer, Inspire
Medical Systems will issue a credit to the original purchaser of the
product.
A. Terms and Conditions
1. The product labeling must indicate a limited warranty exists.
2. For implantable products, this limited warranty applies only for a
product replacement in the original patient.
3. All registration materials must be completed and returned to Inspire
Medical Systems within 30 days of first use.
4. The product must be replaced with an Inspire Medical Systems
product.
5. If the product is implantable, it must be implanted before the
product expires and implanted with other Inspire Medical Systems
products.


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6. The product must be returned to Inspire Medical Systems, 9700
63rd Avenue North Maple Grove, MN 55369 within 30 days that the
product first fails to function within normal tolerances. The product
may be returned at no cost to you. Contact your Inspire Medical
Systems representative for information on how to return the
product.
7. Inspire Medical Systems will inspect the returned product and
determine whether a limited warranty credit is due.
8. All products returned to Inspire Medical Systems become its
property.
This limited warranty represents the entire obligation of Inspire Medical
Systems for products other than tools and is made IN LIEU OF any other
warranties, whether express or implied, including MERCHANTABILITY or
fitness for a particular purpose.
Inspire Medical Systems will not be liable for any damages, whether
direct, consequential, or incidental caused by product defects, failures, or
malfunctions, whether such claims are based on warranty, contract, tort
or otherwise.
No person has any authority to bind Inspire Medical Systems to any
warranty or representation except those specifically contained herein.
This limited warranty gives specific legal rights, and you may also have
other rights, which vary from state to state. If one or more of the provisions
of this limited warranty shall be deemed void or unenforceable, the
remaining provisions shall continue to have full force and effect.
B. Limited Warranty Period
The applicable limited warranty period for each product is listed and
calculated as follows:
1. Three (3) years from date an IPG or lead is implanted in the patient.
2. One (1) year from the date a physician or Inspire Sleep Remote is
first used.
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Manufacturer
Inspire Medical Systems, Inc.
9700 63rd Avenue North
Maple Grove, MN 55369
USA
Tel. 1-844-672-4357 Toll Free
or 763-205-7970
Fax 763-537-4310
www.inspiresleep.com
HealthLink Europe Services BV
De Tweeling 20-22
5215 MC ‘s-Hertogenbosch
The Netherlands
Tel. +31.13.5479300
Attn: Quality Department
© Inspire Medical Systems 2015
All Rights Reserved
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---

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