Inspire SLEEP REMOTE User manual

INSPIRE SLEEP REMOTETM
Rx Only
Inspire Sleep Remote Model 2500

The following is a registered trademark of Inspire Medical Systems, Inc.:
Inspire®
The following is a trademark of Inspire Medical Systems, Inc.: Inspire
Sleep RemoteTM

Inspire Sleep Remote English i
Explanation of Symbols on Product or Package
Sleep Remote Symbols
Turn therapy on, or if therapy is already on, then push to pause
therapy
Turn therapy off
Decrease stimulation strength
Increase stimulation strength
Replace sleep remote batteries
If the light is on but not flashing, your generator battery may be
low
If the light is on and flashing, communication with your
generator has been interrupted
Audio tones on
Audio tones off
Package Symbols
Consult instructions for use
For USA audiences only

ii English Inspire Sleep Remote
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
Conformité Européenne (European Conformity). This symbol
means that the device fully complies with applicable European
Directives
European authorized representative
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 39 for more detailed information.
2797
IP22

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

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.
Decreasing Stimulation Strength
• Press the Decrease button ( ) and hold the sleep
remote over your generator for 10 seconds or until the
sleep remote produces an audio tone.
• If the sleep remote produces three beeps immediately
when you press the Decrease button ( ), stimulation
strength is at the lower limit.
Increasing Stimulation Strength
• Press the Increase button ( ) and hold the sleep
remote over your generator for 10 seconds or until the
sleep remote produces an audio tone.
• If the sleep remote produces three beeps immediately
when you press the Increase button ( ), stimulation
strength is at the upper limit.
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.

Inspire Sleep Remote English v
Figure 2. Sleep remote back view
Status Indicators
Replace sleep remote batteries
If the light is on and not flashing, your generator battery
may be low, call your doctor
If the light is on and flashing, communication with your
generator has been interrupted. Refer to “Interference”
on page 9.
Stimulation strength is at the upper limit
Stimulation strength gauge
Sleep remote
battery light
Generator
light
Upper limit
light
Stimulation
strength
gauge

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

Inspire Sleep Remote English vii
Table of Contents
Explanation of Symbols on Product or Package i
Inspire Sleep RemoteTM Quick Guide iii
Glossary xi
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 9
Interference 9
4. Using Your Sleep Remote 11
Sleep Remote Buttons 12
Status Ring 13
Stimulation Strength Gauge 14
Status Lights 16
Audio Tones 18
Turning Audio Tones On or Off 19

viii English Inspire Sleep Remote
Using Your Inspire Sleep Remote 20
Positioning Your Sleep Remote 20
Communicating with your Generator 23
Turning Therapy On 25
Turning Therapy Off 26
Pausing Therapy 27
Increasing Stimulation Strength 28
Decreasing Stimulation Strength 29
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 39
Cleaning Your Sleep Remote 39
Handling Your Sleep Remote 40
Checking the Sleep Remote 40
Checking the Generator Battery Status 41
7. Troubleshooting Your Sleep Remote 43
8. Specifications 49
Connections to Additional Equipment 50
Do Not Modify 50
FCC Statements 50

Inspire Sleep Remote English ix
Inspire Medical Systems Limited Warranty 53

Inspire Sleep Remote English xi
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.
Hypoglossal Nerve — The nerve that controls tongue
movement.
Implantable Pulse Generator (IPG) — See Generator.
Your doctor may refer to your generator as an IPG or
implantable pulse generator.
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.

xii English Inspire 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.
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.

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

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 AAA or LR03 alkaline batteries
• Sleep Remote Manual and Quick Guide

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

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.

Inspire Sleep Remote English 5
When the delay time has passed, the Inspire system
delivers mild stimulation to the nerve that controls your
tongue movement (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.