Inspire SLEEP REMOTE 2580 User manual

INSPIRE SLEEP REMOTE™
Rx Only
Inspire Sleep Remote Model 2580
200-423-001_Rev A_2580 Manual US.book Page 1

The following is a registered trademark of Inspire Medical Systems, Inc.: Inspire®
The following is a trademark of Inspire Medical Systems, Inc.: Inspire Sleep
Remote™
200-423-001_Rev A_2580 Manual US.book Page 2

Inspire Sleep Remote English i
Explanation of Symbols on Sleep Remote or
Package
Turn therapy on button; or, if therapy is already on, then push
to pause therapy
Turn therapy off button
Decrease stimulation strength button
Increase stimulation strength button
Replace sleep remote batteries status light
Generator battery may be low status light
Communication with your generator has been interrupted
due to Electromagnetic Interference (EMI) status light
Bluetooth® pairing is in process status light
Stimulation strength is at the upper limit status light
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ii English Inspire Sleep Remote
Consult instructions for use
Reference number
Serial number
IEC 60601-1/EN60601-1, Type BF Equipment
This symbol means that the device comes into contact with
the patient
Keep dry, use caution to prevent spilling or splashing liquids
on the sleep remote
Manufacturer
Date of manufacture
MRI unsafe
Temperature limitation
Atmospheric pressure limitation
Relative humidity limitation
IEC 60529, Protection from ingress by fingers or similar
objects and moderate amounts of dripping water
Note: The sleep remote meets the water ingress rating of IP22, maintaining
safe operation. Exposure to water or liquids could result in a loss of
performance. Keep the sleep remote dry. Refer to “Battery and Sleep
Remote Disposal” on page 40 for more detailed information.
IP22
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Inspire Sleep Remote English iii
Inspire Sleep RemoteTM Quick Guide
Figure 1. Sleep remote front view
Turning Therapy On
• Press the Therapy On ( ) button and hold the sleep remote
over your generator for 10 seconds or until the sleep remote
produces an audio tone.
• When therapy is turned on, the generator will produce a brief
stimulation pulse.
Status Ring
White Therapy is off
Green – Solid Therapy is on and stimulation is on
Green – Dimming and brightening Therapy is on, stimulation is paused
Therapy On
Therapy Off
Increase (stimulation
strength)
Decrease (stimulation
strength)
Status ring
Pause
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iv English Inspire Sleep Remote
Turning Therapy Off
• Press the Therapy Off button ( ) and hold the sleep remote
over your generator for 10 seconds or until the sleep remote
produces an audio tone.
Note: Removing the batteries from your sleep remote will not
turn off the therapy.
Decreasing Stimulation Strength
• Press the Decrease button ( ) and hold the sleep remote
over your generator for 10 seconds. When audio is enabled,
the sleep remote will produce an audio tone when you
decrease stimulation.
• If the stimulation strength is at the lower limit when you press
the Decrease button ( ) and audio is enabled, the remote
will immediately emit three beeps.
Increasing Stimulation Strength
• Press the Increase button ( ) and hold the sleep remote
over your generator for 10 seconds. When audio is enabled,
the sleep remote will produce an audio tone when you
increase stimulation.
• If the stimulation strength is at the upper limit when you press
the Increase button ( ) and audio is enabled, the remote
will immediately emit three beefs.
Pausing Therapy
• While therapy is on, press the Therapy On button ( ) and
hold the sleep remote over your generator for 10 seconds or
until the sleep remote produces an audio tone.
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Inspire Sleep Remote English v
Figure 2. Sleep remote back view
Status Indicators
Replace sleep remote batteries
If the light is on, your generator battery may be low or
therapy disabled, call your doctor
If the light is on and flashing, communication with your
generator has been interrupted due to Electromagnetic
Interference (EMI). Refer to “Interference” on page 8.
Stimulation strength is at the upper limit
Stimulation strength gauge
Bluetooth pairing is in process
Sleep remote
battery light
Bluetooth
EMI
Upper limit
light
Stimulation
strength gauge
Generator light
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vi English Inspire Sleep Remote
Finding the Generator
• Press the Therapy Off button ( ) and move the sleep remote
near your generator. When the sleep remote produces two
beeps, with the second beep at a higher tone than the first,
you have found the generator location.
• If the sleep remote produces three rapid beeps, you have not
found the generator location. Try again.
Audio Tones
Two beeps with the
second beep at a
higher tone than the
first
• Communication with the generator
was successful
Three rapid beeps • Communication with the generator
was not successful, try again
• Stimulation is at the upper or lower
limit
Two beeps that
repeat
• Sleep remote is updating the generator
• Wait until complete, when the success
tone is played
• Update may take several seconds
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Inspire Sleep Remote English vii
Table of Contents
Explanation of Symbols on Product or Package i
Inspire Sleep RemoteTM Quick Guide iii
Glossary ix
1. Introduction 1
About This Manual 2
Package Contents 2
2. Inspire Therapy 3
Your Inspire System 3
Therapy Summary 4
Additional Therapy Information 5
Frequently Asked Therapy Questions 5
3. Safety Information 7
Warnings 7
Precautions 8
System and Therapy 8
Patient Activities 8
Interference 8
4. Using Your Sleep Remote 11
Sleep Remote Buttons 12
Status Ring 13
Stimulation Strength Gauge 14
Status Lights 16
Bluetooth Pairing with a Mobile Phone 18
Using Your Inspire Sleep Remote 21
Positioning Your Sleep Remote 21
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viii English Inspire Sleep Remote
Communicating with your Generator 24
Turning Therapy On 26
Turning Therapy Off 27
Pausing Therapy 28
Increasing Stimulation Strength 29
Decreasing Stimulation Strength 30
5. Living with Your Inspire System 33
Travel Information 33
When to Call Your Doctor 33
Manufacturer's Information 34
6. Maintaining Your Inspire Sleep Remote 35
Sleep Remote Batteries 35
Checking the Sleep Remote Battery Status 36
Replacing the Sleep Remote Batteries 37
Battery and Sleep Remote Disposal 40
Cleaning Your Sleep Remote 40
Handling Your Sleep Remote 41
Checking the Sleep Remote 41
Checking the Generator Battery Status 42
7. Troubleshooting Your Sleep Remote 43
8. Specifications 51
Connections to Additional Equipment 52
Do Not Modify 52
FCC Statements 52
Inspire Medical Systems Limited Warranty 55
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Inspire Sleep Remote English ix
Glossary
Apnea — A temporary absence of breathing.
Caution — A statement describing actions that could result in
minor or moderate injury to the patient, device damage, or
improper functioning of a device.
Contraindication — A condition or circumstance when a person
should not have an Inspire system.
Generator — The implanted component of the Inspire system
that contains the battery and electronics that control stimulation.
Your doctor may also refer to your generator as an IPG or
implantable pulse generator.
Hypoglossal Nerve — The nerve that controls tongue movement.
Lead — A thin, implanted wire with protective coating that
connects to the generator. The Inspire system has a respiratory
sensing lead and a stimulation lead.
Pause — A delay in therapy that allows the patient to temporarily
stop stimulation without turning the therapy off. The pause time
allows the patient to fall asleep before stimulation begins again.
Precaution — See Caution.
Remote — See Sleep Remote.
Sleep Remote — Device the patient uses to turn therapy on and
off, and to change stimulation strength within limits set by a
doctor.
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x English Inspire Sleep Remote
Start Delay — A delay between when the therapy is turned on
and when the stimulation begins. Start Delay allows the patient
to fall asleep before stimulation begins.
Stimulation — The delivery of electrical pulses to the nerve that
controls tongue movement (see Hypoglossal Nerve).
Stimulation Strength — The stimulation level (amplitude)
measured in volts.
Therapy — Treatment of a disease or condition. The Inspire
system uses stimulation to provide therapy.
Therapy Settings — The settings, stored in the generator, that
define the therapy you receive.
Upper Airway — The breathing path from the mouth and nostrils
to the larynx (voice box).
Warning — A statement describing an action or situation that
could seriously harm the patient.
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Inspire Sleep Remote English 1
1. Introduction
You have received an Inspire system to deliver Inspire® Upper
Airway Stimulation (UAS) therapy (Figure 3a). Your doctor has
given you an Inspire Sleep RemoteTM (Figure 3b). Use your sleep
remote to turn your therapy on and off and adjust the strength of
stimulation.
Figure 3. Inspire system
a
b
Implanted
components
Inspire Sleep Remote
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2 English Inspire Sleep Remote
About This Manual
This manual provides information on using and maintaining your
Inspire Sleep Remote. The sleep remote should only be used
according to the instructions in this manual and the instructions
provided by your doctor.
This manual also contains information about Inspire therapy. This
includes answers to common questions about living with an
Inspire system. For additional information about your implanted
Inspire System, refer to the Patient Manual you received after
your implant surgery.
Information is provided about what to do if you encounter
problems with your Inspire system and when you should call your
doctor. If you have questions that are not answered in this
manual, or if any unusual situations or problems occur, talk to
your doctor. For more information about Inspire therapy and the
Inspire system, refer to “Inspire Therapy” on page 3 and your
Inspire Patient Manual.
Package Contents
The sleep remote package contains the following:
• One Inspire Sleep Remote
• Two AA or LR6 alkaline batteries
• Sleep Remote Manual and Quick Guide
• Sleep Remote carrying case
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Inspire Sleep Remote English 3
2. Inspire Therapy
You have received an Inspire system to deliver Inspire Upper
Airway Stimulation (UAS) therapy. Your doctor prescribed UAS
therapy to treat your sleep apnea.
For more information about your Inspire system, refer to your
Inspire Patient Manual.
Your Inspire System
Figure 4. Implanted components of the Inspire system
Stimulation lead
Respiratory sensing
lead
Generator
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4 English Inspire Sleep Remote
The implanted components of the Inspire system (Figure 4) are a
generator, a stimulation lead, and a respiratory sensing lead. For
more detailed information about each component, refer to your
Inspire Patient Manual or contact your doctor.
•Generator — Contains the battery and electronics that
provide stimulation.
•Respiratory sensing lead — When therapy is on, this lead
monitors your breathing.
•Stimulation lead — When therapy is on, this lead delivers
stimulation to activate the muscles in your upper airway.
The external components of the Inspire system are:
•Sleep remote — That you use to control your implanted
system.
•Physician programmer — That your doctor uses to program
your therapy settings.
Therapy Summary
Inspire therapy is only used when you are sleeping. You will turn
your therapy off during the day.
When you are preparing to go to sleep, you will use your sleep
remote to turn your therapy on. You will feel a brief stimulation
confirming that therapy has been turned on. After the
confirmation, stimulation is delayed so you have time to fall
asleep.
When the delay time has passed, the Inspire system delivers mild
stimulation to the nerve that controls your tongue movement
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Inspire Sleep Remote English 5
(the hypoglossal nerve) as it senses breathing. The stimulation
causes the upper airway muscles to stiffen, preventing airway
blockages. The therapy does not wait for an apnea to occur before
delivering stimulation.
Stimulation is delivered throughout the night to prevent apneas.
Additional Therapy Information
For additional information, such as therapy indications,
contraindications, risks, benefits, and surgical procedure
description, refer to your Inspire Patient Manual.
Frequently Asked Therapy Questions
What does stimulation feel like?
Most patients report that stimulation is a mild sensation.
Stimulation results in an involuntary movement of the upper
airway muscles and/or tongue. If the stimulation strength is too
high, the upper airway may have a strong response that may be
uncomfortable. Stimulation strength can be adjusted so that
therapy is comfortable and effective.
Will I feel anything when I turn therapy on?
Yes. When therapy is turned on you should feel a brief stimulation
for a few seconds. Then stimulation is delayed for a period of time
while you fall asleep. After this Start Delay, stimulation resumes.
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6 English Inspire Sleep Remote
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Inspire Sleep Remote English 7
3. Safety Information
The following warnings and precautions are in regard to the sleep
remote. For additional warnings and precautions regarding
Inspire therapy overall, refer to your Inspire Patient Manual. The
Inspire Patient Manual includes safety information about medical
procedures, equipment, devices, and activities that could
interfere with the function of your Inspire system. If you need
another Inspire Patient Manual, please contact your doctor or
Inspire Medical Systems Inc. to request a replacement.
Warnings
Choking hazard. The sleep remote batteries may pose a choking
hazard. Keep the sleep remote and batteries away from children
and pets.
Flammable environment. Avoid using the sleep remote in the
presence of flammable gases and/or fumes. An interaction
between the flammable environment and the batteries in the
sleep remote could occur. The consequences of using a battery-
powered device near flammable environments are unknown.
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8 English Inspire Sleep Remote
Precautions
System and Therapy
Using a programmer or a sleep remote with other medical
devices. Do not use the sleep remote on another medical device,
such as a cardiac pacemaker. The sleep remote is not compatible
with other medical devices. Using the sleep remote with other
devices will not make the desired (or any) adjustment. Therefore,
that medical device may not perform its function in the desired
manner and could lead to improperly treated symptoms. For the
same reasons, do not use a sleep remote or programmer from
another medical device with your Inspire generator.
Keep the sleep remote dry. Keep the sleep remote away from
sources of water and condensation such as sinks and humidifiers.
Failure to keep the sleep remote dry could damage the sleep
remote.
Sleep remote modification. Do not modify (change) the sleep
remote. Modification of the sleep remote can result in damage to
the sleep remote, causing it to not work properly.
Patient Activities
Children and pets. Keep the sleep remote away from children
and pets. Children or pets may damage the sleep remote.
Interference
Any electric device could be a potential source of interference
with the communication between your remote and your
generator. See below for typical examples of equipment in your
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