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

200-161-101 Rev A3032PatEN_fcv.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002INSPIRE SLEEP REMOTETMRx OnlyInspire Sleep Remote Model 2500
200-161-101 Rev A3032PatEN_fcv.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002The 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 i200-161-101 Rev A3032PatEN_sym.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Explanation of Symbols on Product or PackageSleep Remote SymbolsTherapy onTherapy offStimulation strength decreaseStimulation strength increaseSleep remote batteriesGenerator status Audio tones onAudio tones off Package SymbolsConsult instructions for useFor USA audiences onlySerial number
ii English Inspire Sleep Remote200-161-101 Rev A3032PatEN_sym.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002IEC 60601-1/EN60601-1, Type BF EquipmentThis symbol means that the device comes into contact with the patientKeep dry, use caution to prevent spilling or splashing liquids on the sleep remoteConformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European DirectivesEuropean authorized representativeIEC 60529, Protection from ingress by fingers or similar objects and moderate amounts of dripping waterNote: 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
Inspire Sleep Remote English iii200-161-101 Rev A3032PatEN_QRef.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Inspire Sleep RemoteTM Quick GuideFigure 1. Sleep remote front viewTurning 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 RingWhite Therapy is offGreen – Solid Therapy is on and stimulation is onGreen – Dimming and brightening Therapy is on, stimulation is pausedTherapy OnTherapy Off Increase (stimulation strength)Decrease(stimulation strength)Status ringPause
iv English Inspire Sleep Remote200-161-101 Rev A3032PatEN_QRef.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Turning 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.
Inspire Sleep Remote English v200-161-101 Rev A3032PatEN_QRef.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Figure 2. Sleep remote back view Status IndicatorsReplace sleep remote batteriesIf the light is on and not flashing, your generator battery may be low, call your doctorStimulation strength is at the upper limitStimulation strength gaugeSleep remote battery lightGeneratorlightUpper limit lightStimulationstrengthgauge
vi English Inspire Sleep Remote200-161-101 Rev A3032PatEN_QRef.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Finding 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 TonesTwo beeps with a rising tone • Communication with the generator was successfulThree rapid beeps • Communication with the generator was not successful, try again• Stimulation is at the upper or lower limit
Inspire Sleep Remote English vii200-161-101 Rev A3032PatEN_TOC.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Table of ContentsExplanation of Symbols on Product or Package iInspire Sleep RemoteTM Quick Guide iiiGlossary xi1. Introduction 1About This Manual 2Package Contents 22. Inspire Therapy 3Your Inspire System 3Therapy Summary 4Additional Therapy Information 5Frequently Asked Therapy Questions 53. Safety Information 7Warnings 7Precautions 7Medical Procedures 7Electromagnetic Interference 8Theft Detector or Security Screening Devices 9System and Therapy 10Patient Activities 11MRI and Other Medical Procedures 12Mobile Devices and Common Household Electrical Items 124. Using Your Sleep Remote 15Sleep Remote Buttons 16Status Ring 17Stimulation Strength Gauge 18
viii English Inspire Sleep Remote200-161-101 Rev A3032PatEN_TOC.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Status Lights 20Audio Tones 22Turning Audio Tones On or Off 23Using Your Inspire Sleep Remote 24Positioning Your Sleep Remote 24Communicating with your Generator 27Turning Therapy On 29Turning Therapy Off 30Pausing Therapy 31Increasing Stimulation Strength 32Decreasing Stimulation Strength 335. Living with Your Inspire System 35Activities and Exercise 35Travel Information 35When to Call Your Doctor 36Manufacturer's Information 376. Maintaining Your Inspire Sleep Remote 39Sleep Remote Batteries 39Checking the Sleep Remote Battery Status 40Replacing the Sleep Remote Batteries 41Battery and Sleep Remote Disposal 43Cleaning Your Sleep Remote 43Handling Your Sleep Remote 44Checking the Generator Battery Status 447. Troubleshooting Your Sleep Remote 458. Specifications 51Connections to Additional Equipment 52
Inspire Sleep Remote English ix200-161-101 Rev A3032PatEN_TOC.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Do Not Modify 52FCC Statements 52Inspire Medical Systems Limited Warranty 55
x English Inspire Sleep Remote200-161-101 Rev A3032PatEN_TOC.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
Inspire Sleep Remote English xi200-161-101 Rev A3032PatEN_gl.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Glossary 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.
xii English Inspire Sleep Remote200-161-101 Rev A3032PatEN_gl.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Hypoglossal 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.
Inspire Sleep Remote English xiii200-161-101 Rev A3032PatEN_gl.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Therapy 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.
xiv English Inspire Sleep Remote200-161-101 Rev A3032PatEN_gl.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
Inspire Sleep Remote English 1200-161-101 Rev A3032PatEN_ch1.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0021. IntroductionYou 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 systemabImplantedcomponents Inspire Sleep Remote
2 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch1.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002About This ManualThis 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 ContentsThe 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 3200-161-101 Rev A3032PatEN_ch2.fm 10/30/15 8:54 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0022. Inspire TherapyYou 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 SystemFigure 4. Implanted components of the Inspire systemStimulation leadRespiratorysensing leadGenerator
4 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch2.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002The 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 SummaryInspire 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.
Inspire Sleep Remote English 5200-161-101 Rev A3032PatEN_ch2.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Stimulation is delivered throughout the night to prevent apneas.Additional Therapy InformationFor additional information, such as therapy indications, contraindications, risks, benefits, and surgical procedure description, refer to your Inspire Patient Manual.Frequently Asked Therapy QuestionsWhat 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.
6 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch2.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Is 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.
Inspire Sleep Remote English 7200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0023. Safety InformationWarningsFor 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.PrecautionsMedical ProceduresConsult 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
8 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002• High-output ultrasonics / lithotripsy (If lithotripsy must be used, consult your doctor.)For additional safety information, refer to your Inspire Patient Manual.Electromagnetic InterferenceThe 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)
Inspire Sleep Remote English 9200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002If 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 DevicesUse 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
10 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002walking 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 TherapyUsing 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
Inspire Sleep Remote English 11200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002humidifiers. 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 ActivitiesChildren 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.
12 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Skydiving, 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 ProceduresIf 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 ItemsMost 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:
Inspire Sleep Remote English 13200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002•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.
14 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch3.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0024. 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.
Inspire Sleep Remote English 15200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0024. Using Your Sleep RemoteYour 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 generatorSleep remoteGeneratorRadio signals
16 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Sleep Remote ButtonsFigure 6. Sleep remote buttonsThe 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 offDecrease the stimulation strengthIncrease the stimulation strengthTherapy OnTherapy Off Increase (stimulation strength)Decrease(stimulation strength)Status ringPause
Inspire Sleep Remote English 17200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Status RingFigure 7. Status ringThe 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 offSolid green Therapy is on and stimulation is activeSlowly dimming and brightening green Therapy is on and stimulation is pausedFlashing 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
18 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002does not respond to a gentle shake, press the Therapy Off button ( ) and wait for 10 seconds.Stimulation Strength GaugeYour 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. StimulationstrengthgaugeStimulation strength gaugeUpper limit light
Inspire Sleep Remote English 19200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002To 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 decreasedUpper limit light on Stimulation strength is at maximum and may not be increasedSolid white Therapy is offSolid green Therapy is on and stimulation is activeSlowly dimming and brightening greenTherapy is on and stimulation is paused
20 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Status LightsFigure9. StatuslightsThe 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 lightGeneratorlight
Inspire Sleep Remote English 21200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Status light: Means:Both status lights off Sleep remote and generator are operating normallySleep remote battery light onSleep remote batteries are low and need to be changedGenerator light on Contact your doctorBoth status lights onReplace 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 flashingCommunication with your generator has been interrupted by electromagnetic interference. Move away from potential sources of interference, and try again.

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