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

Inspire Medical Systems, Inc. Patient Programmer for IPG 3032EN

Contents

User Manual Part 1

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INSPIRE SLEEP REMOTETM
Rx Only
Inspire Sleep Remote Model 2500
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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
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Explanation of Symbols on Product or Package
Sleep Remote Symbols
Therapy on
Therapy off
Stimulation strength decrease
Stimulation strength increase
Sleep remote batteries
Generator status
Audio tones on
Audio tones off
Package Symbols
Consult instructions for use
For USA audiences only
Serial number
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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 43 for more detailed information.
IP22
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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 you
hear an audio tone.
• When therapy is turned on you will feel a brief
stimulation.
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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Turning Therapy Off
• Press the Therapy Off button ( ) and hold the sleep
remote over your generator for 10 seconds or until you
hear an audio tone.
Decreasing Stimulation Strength
• Press the Decrease button ( ) and hold the sleep
remote over your generator for 10 seconds or until you
hear an audio tone.
• If you hear 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 you
hear an audio tone.
• If you hear 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 you hear an audio tone.
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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
Stimulation strength is at the upper limit
Stimulation strength gauge
Sleep remote
battery light
Generator
light
Upper limit
light
Stimulation
strength
gauge
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Finding the Generator
• Press the Therapy Off button ( ) and move the sleep
remote near your generator. When you hear two beeps
with a rising tone, you have found the generator location.
• If you hear three rapid beeps, you have not found the
generator location. Try again.
Audio Tones
Two beeps with a
rising tone
• 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
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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 7
Medical Procedures 7
Electromagnetic Interference 8
Theft Detector or Security Screening Devices 9
System and Therapy 10
Patient Activities 11
MRI and Other Medical Procedures 12
Mobile Devices and Common Household Electrical Items 12
4. Using Your Sleep Remote 15
Sleep Remote Buttons 16
Status Ring 17
Stimulation Strength Gauge 18
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Status Lights 20
Audio Tones 22
Turning Audio Tones On or Off 23
Using Your Inspire Sleep Remote 24
Positioning Your Sleep Remote 24
Communicating with your Generator 27
Turning Therapy On 29
Turning Therapy Off 30
Pausing Therapy 31
Increasing Stimulation Strength 32
Decreasing Stimulation Strength 33
5. Living with Your Inspire System 35
Activities and Exercise 35
Travel Information 35
When to Call Your Doctor 36
Manufacturer's Information 37
6. Maintaining Your Inspire Sleep Remote 39
Sleep Remote Batteries 39
Checking the Sleep Remote Battery Status 40
Replacing the Sleep Remote Batteries 41
Battery and Sleep Remote Disposal 43
Cleaning Your Sleep Remote 43
Handling Your Sleep Remote 44
Checking the Generator Battery Status 44
7. Troubleshooting Your Sleep Remote 45
8. Specifications 51
Connections to Additional Equipment 52
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Do Not Modify 52
FCC Statements 52
Inspire Medical Systems Limited Warranty 55
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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.
Diathermy — A medical treatment applied to the outside of
the body that delivers energy into the body. Depending on
the power level used, diathermy devices may or may not
produce heat within the body. This treatment is typically
used to relieve pain, stiffness and muscle spasms, reduce
joint contractures (in other words, shortening of muscles or
tendons), reduce swelling and pain after surgery, and
promote wound healing.
Electromagnetic Disturbance — An electromagnetic
event that may degrade the performance of a device.
Electromagnetic Interference (EMI) — The effect of an
electromagnetic disturbance that prevents the generator or
sleep remote from working properly. For example,
electromagnetic interference could prevent your generator
from communicating with your sleep remote.
Generator — The implanted component of the Inspire
system that contains the battery and electronics that control
stimulation.
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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.
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.
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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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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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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
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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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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.
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 (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.
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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.
How long will my generator battery last?
For information on battery life and replacement, refer to your
Inspire Patient Manual.
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Is it normal for the stimulation sensation to change
when I change position?
Yes, it is normal to notice minor changes in stimulation
sensation when you change position.
For more information regarding your Inspire system, refer to
your Inspire Patient Manual.
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3. Safety Information
Warnings
For additional warnings and safety information, refer to your
Inspire Patient Manual.
Choking hazard. The sleep remote batteries may pose a
choking hazard. Keep the sleep remote and batteries away
from children and pets.
Precautions
Medical Procedures
Consult your doctor regarding the following medical
procedures. These procedures may cause permanent
damage to the generator, particularly if used in close
proximity to the device:
• Dental drills and ultrasonic probes
•Electrolysis
• Bone growth stimulators
• Laser procedures
• Radiation therapy
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• High-output ultrasonics / lithotripsy (If lithotripsy must be
used, consult your doctor.)
For additional safety information, refer to your Inspire
Patient Manual.
Electromagnetic Interference
The following equipment or environments could generate
enough electromagnetic disturbance to potentially create
unwanted stimulation from your generator. Avoid them if
possible.
• Antennas of citizen band (CB) or ham radios
• Electric arc welding equipment
• Electric induction heaters
• Electric steel furnaces
• Equipment used for decreasing or eliminating magnetic
fields
• High-voltage areas (safe when outside the fenced area)
• Linear power amplifiers
• Microwave communication transmitters (safe when
outside the fenced area)
• Perfusion systems (for example, hospital equipment
used for maintaining blood flow)
• Power lines or power generators
• Resistance welders
• Television and radio transmitting towers (safe when
outside the fenced area)
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If you suspect that equipment is causing unwanted
stimulation or interfering with the implanted Inspire system,
do the following:
1. Move away from the equipment or object.
2. If possible, turn off the equipment or object.
3. Use the sleep remote to turn your therapy off.
4. Inform the equipment owner or operator about the
interference. If the above actions do not resolve the
effects of the interference, or you suspect that your
therapy is not the same after exposure to
electromagnetic interference, contact your doctor.
For additional safety information, refer to your Inspire
Patient Manual.
Theft Detector or Security Screening Devices
Use care when approaching theft detectors and security
devices (such as those found in airports, libraries,
department stores, and government buildings). When
approaching these devices, do the following:
1. Show the security personnel your Inspire Identification
Card and ask for a manual search. If security personnel
use a handheld security wand, ask them not to hold the
security wand near the generator longer than needed.
2. If you must pass through the theft detector or security
screening device, make sure your therapy is off. When
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walking through the device, keep as far from it as
possible.
Note: Some theft detectors might not be visible.
3. Proceed through the security device. Do not linger near
or lean on the security device.
For additional safety information, refer to your Inspire
Patient Manual.
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.
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.
Keep the sleep remote dry. Keep the sleep remote away
from sources of water and condensation such as sinks and
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humidifiers. Failure to keep the sleep remote dry could
damage the sleep remote.
Sleep remote connection to other equipment. Do not
connect the sleep remote to other equipment, cables, or
devices. The sleep remote is only for use with the Inspire
system. Connection to other equipment 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. The sleep remote batteries may pose a
choking hazard. Also, children or pets may damage the
sleep remote.
Component manipulation (twiddler's syndrome). Do not
manipulate (move) or rub your generator or leads through
your skin; this is sometimes called “twiddler's syndrome.”
Manipulation can cause damage to the components, lead
dislodgement, skin damage, or unintended stimulation.
Scuba diving or hyperbaric chambers. Do not dive below
10 meters (33 feet) of water or enter hyperbaric chambers
above 2.0 atmospheres absolute (ATA). Pressures below 10
meters (33 feet) of water (or above 2.0 ATA) can damage
your generator or leads. Before diving or using a hyperbaric
chamber, discuss the effects of high pressure with your
doctor.
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Skydiving, skiing, or hiking in the mountains. High
altitudes should not affect the generator; however, you
should consider the movements involved in such activities,
and take precaution to not put undue stress on your
generator or leads. During skydiving, the sudden jerking that
occurs when the parachute opens can dislodge or break a
lead, requiring additional surgery to repair or replace the
lead.
For additional safety information, refer to your Inspire
Patient Manual.
MRI and Other Medical Procedures
If you need or desire a procedure like MRI or diathermy,
consult your Inspire Patient Manual or your doctor to
determine if the medical procedure is safe for you.
The sleep remote contains metal and should be kept away
from MRI equipment.
Mobile Devices and Common Household
Electrical Items
Most of the electrical devices that you encounter in an
ordinary day are unlikely to affect your Inspire system.
However, electromagnetic interference can impact you and
your Inspire system in certain situations. The following
equipment is unlikely to affect your system if you follow
these guidelines:
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•Mobile phones and other radio-frequency sources (tablet
computers, AM/FM radios, cordless and conventional
telephones): Keep these items at least 15 cm (6 in) away
from the generator.
•Induction range: Keep the generator away from the
burners while the burners are turned on. Induction
ranges, unlike conventional electric stoves, produce
magnetic fields to generate heat.
•Power tools: Keep the motor away from the generator
and leads.
•Sewing machines or salon hair dryer: Keep the generator
away from the motors.
Some devices can interfere with the communication
between your generator and sleep remote.
•Home wireless products such as walkie-talkies,
Bluetooth, or WiFi networking devices. Stay 30 cm (1 ft)
away from such devices when using your sleep remote.
•Mobile phones. Note that mobile phones may interfere
with sleep remote communications if operated at the
same time and within 70 cm (2.3 ft).
If you suspect that equipment is causing unwanted
stimulation or interfering with your Inspire system, do the
following:
1. Move away from the equipment or object.
2. If possible, turn off the equipment or object.
3. Use the sleep remote to turn your therapy off.
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4. If the above actions do not resolve the effects of the
interference, or you suspect that your therapy is not the
same after exposure to electromagnetic interference,
contact your doctor.
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4. Using Your Sleep Remote
Your sleep remote allows you to turn your therapy on before
you go to sleep, off during waking hours, and pause therapy
if you wake and need time to fall back to sleep. It also allows
you to adjust the stimulation strength within a range
determined by your doctor. You also use your sleep remote
to check the status of your generator battery.
The sleep remote communicates with your generator by
sending and receiving short range radio signals to and from
your generator. To communicate with your generator, the
sleep remote Therapy On button ( ) must be placed
directly over your generator (Figure 5).
Figure 5. Communication between sleep remote and generator
Sleep remote
Generator
Radio signals
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Sleep Remote Buttons
Figure 6. Sleep remote buttons
The sleep remote buttons (Figure 6) allow you to turn your
therapy on and off, and to pause therapy. Also, you can
increase or decrease your stimulation strength within a
range selected by your doctor.
Select: To:
Turn therapy on. If therapy is on, pause therapy.
Turn therapy off
Decrease the stimulation strength
Increase the stimulation strength
Therapy On
Therapy Off
Increase
(stimulation strength)
Decrease
(stimulation strength)
Status ring
Pause
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Status Ring
Figure 7. Status ring
The sleep remote has a status ring (Figure 7) around the
Therapy On button ( ). The status ring lights up and
indicates if therapy is on, off, or paused.
To check your therapy status:
• Pick up or gently shake the sleep remote. The status ring
lights up to indicate your therapy status.
Note: Your sleep remote may not respond to a gentle shake
if it has been excessively bounced during the previous 30
minutes, such as when it has been in a car. If your remote
Status ring light: Means:
Solid white Therapy is off
Solid green Therapy is on and stimulation is active
Slowly dimming and
brightening green Therapy is on and stimulation is paused
Flashing yellow bars
A yellow status light on the back of the sleep
remote is on. Turn the sleep remote over and
review the status lights.
Status ring
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does not respond to a gentle shake, press the Therapy Off
button ( ) and wait for 10 seconds.
Stimulation Strength Gauge
Your doctor may have provided a range of stimulation
strength values for you to use. If you have a range of
stimulation strengths available, the increase ( ) and
decrease ( ) stimulation strength buttons allow you to
change the stimulation strength.
The stimulation strength gauge on the back of the sleep
remote indicates the current stimulation strength, and if the
stimulation strength has reached the upper or lower limit
(Figure 8). The stimulation strength gauge color also
indicates if therapy is on, off, or paused.
Note: If your doctor did not program a range of stimulation
strengths for you to use, the Increase ( ) and Decrease
( ) buttons do not change your stimulation strength.
Figure 8. Stimulationstrengthgauge
Stimulation
strength
gauge
Upper limit
light
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To check your stimulation strength:
• Pick up or gently shake the sleep remote. The stimulation
strength gauge indicates your current stimulation
strength.
Note: Your sleep remote may not respond to a gentle
shake if it has been excessively bounced during the
previous 30 minutes, such as when it has been in a car.
If your remote does not respond to a gentle shake, press
the Therapy Off button ( ) and wait for 10 seconds.
Stimulation strength
gauge:
Means:
One bar lit Stimulation strength is at minimum and
may not be decreased
Upper limit light on Stimulation strength is at maximum and
may not be increased
Solid white Therapy is off
Solid green Therapy is on and stimulation is active
Slowly dimming and
brightening green
Therapy is on and stimulation is paused
20 English Inspire Sleep Remote
200-161-101 Rev A
3032PatEN_ch4.fm 10/30/15 8:55 am
4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential
Inspire 002
Status Lights
Figure9. Statuslights
The generator light and the sleep remote battery light on the
back of your sleep remote indicate the status of your
generator and sleep remote batteries (Figure 9).
Note: When either status light turns on, yellow bars on the
status ring flash. The status ring is on the front of the sleep
remote. The bars flash for several seconds to notify you to
check the status lights on the back of the sleep remote.
Sleep remote
battery light
Generator
light
Inspire Sleep Remote English 21
200-161-101 Rev A
3032PatEN_ch4.fm 10/30/15 8:55 am
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
Inspire 002
Status light: Means:
Both status lights off Sleep remote and generator are operating
normally
Sleep remote
battery light on
Sleep remote batteries are low and need
to be changed
Generator light on Contact your doctor
Both status lights
on
Replace sleep remote batteries, because
low batteries may be preventing normal
sleep remote operation.
If condition persists, contact your doctor.
Your sleep remote may not be working
properly.
Generator light
flashing
Communication with your generator has
been interrupted by electromagnetic
interference. Move away from potential
sources of interference, and try again.

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