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
200-423-001_Rev A_2580 Manual US.book Page i

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
200-423-001_Rev A_2580 Manual US.book Page ii

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.
200-423-001_Rev A_2580 Manual US.book Page iv

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
200-423-001_Rev A_2580 Manual US.book Page vi

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
200-423-001_Rev A_2580 Manual US.book Page viii