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User Manual Part 1 | Users Manual | 4.97 MiB | November 01 2016 / September 07 2016 | |||
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User Manual Part 2 | Users Manual | 5.48 MiB | November 01 2016 / September 07 2016 | |||
1 | Cover Letter(s) | November 01 2016 | ||||||
1 | Cover Letter(s) | November 01 2016 | ||||||
1 | External Photos | November 01 2016 / September 07 2016 | ||||||
1 | Internal Photos | November 01 2016 / September 07 2016 | ||||||
1 | ID Label/Location Info | November 01 2016 | ||||||
1 | RF Exposure Info | November 01 2016 | ||||||
1 | Test Report | November 01 2016 | ||||||
1 | Test Setup Photos | November 01 2016 / September 07 2016 |
1 | User Manual Part 1 | Users Manual | 4.97 MiB | November 01 2016 / September 07 2016 |
3032PatEN_fcv.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 INSPIRE SLEEP REMOTETM Inspire Sleep Remote Model 2500 Rx Only 200-161-101 Rev A 3032PatEN_fcv.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 200-161-101 Rev A 3032PatEN_sym.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Inspire Sleep Remote English i 200-161-101 Rev A 3032PatEN_sym.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Conformit Europenne (European Conformity). This symbol means that the device fully complies with applicable European Directives European authorized representative IP22 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. ii English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_QRef.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Inspire Sleep RemoteTM Quick Guide Therapy On Pause Decrease
(stimulation strength) Status ring Increase
(stimulation strength) Therapy Off Figure 1. Sleep remote front view Status Ring White Green Solid Green Dimming and brightening Turning Therapy On Press the Therapy On (
Therapy is off Therapy is on and stimulation is on Therapy is on, stimulation is paused
) 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. Inspire Sleep Remote English iii 200-161-101 Rev A 3032PatEN_QRef.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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
), stimulation strength is at the lower Decrease button (
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
), stimulation strength is at the upper Increase button (
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.
) iv English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_QRef.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Stimulation strength gauge Generator light Upper limit light Sleep remote battery light 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 Inspire Sleep Remote English v 200-161-101 Rev A 3032PatEN_QRef.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. Two beeps with a rising tone Three rapid beeps Audio Tones Communication with the generator was successful Communication with the generator was not successful, try again Stimulation is at the upper or lower limit vi English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_TOC.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Inspire Sleep Remote English vii 200-161-101 Rev A 3032PatEN_TOC.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 viii English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_TOC.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Do Not Modify 52 FCC Statements 52 Inspire Medical Systems Limited Warranty 55 Inspire Sleep Remote English ix 200-161-101 Rev A 3032PatEN_TOC.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 x English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_gl.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. Inspire Sleep Remote English xi 200-161-101 Rev A 3032PatEN_gl.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. xii English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_gl.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 xiii 200-161-101 Rev A 3032PatEN_gl.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 xiv English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch1.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. Implanted components Inspire Sleep Remote a b Figure 3. Inspire system Inspire Sleep Remote English 1 200-161-101 Rev A 3032PatEN_ch1.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 2 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch2.fm 10/30/15 8:54 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Stimulation lead Generator Respiratory sensing lead Figure 4. Implanted components of the Inspire system Inspire Sleep Remote English 3 200-161-101 Rev A 3032PatEN_ch2.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. 4 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch2.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. Inspire Sleep Remote English 5 200-161-101 Rev A 3032PatEN_ch2.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. 6 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Inspire Sleep Remote English 7 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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) 8 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 Inspire Sleep Remote English 9 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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 10 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. Inspire Sleep Remote English 11 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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:
12 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 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. Inspire Sleep Remote English 13 200-161-101 Rev A 3032PatEN_ch3.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 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. 14 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 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 (
directly over your generator (Figure 5).
) must be placed Sleep remote Radio signals Generator Figure 5. Communication between sleep remote and generator Inspire Sleep Remote English 15 200-161-101 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 Sleep Remote Buttons Therapy On Pause Decrease
(stimulation strength) Status ring Increase
(stimulation strength) Therapy Off 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 16 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 Ring Status ring Figure 7. Status ring The sleep remote has a status ring (Figure 7) around the Therapy On button (
indicates if therapy is on, off, or paused. To check your therapy status:
Pick up or gently shake the sleep remote. The status ring
). The status ring lights up and lights up to indicate your therapy status. Status ring light:
Solid white Solid green Slowly dimming and brightening green Flashing yellow bars Means:
Therapy is off Therapy is on and stimulation is active Therapy is on and stimulation is paused A yellow status light on the back of the sleep remote is on. Turn the sleep remote over and review the status lights. 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 Inspire Sleep Remote English 17 200-161-101 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
) stimulation strength buttons allow you to 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 (
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. Upper limit light Stimulation strength gauge Figure 8. Stimulationstrengthgauge 18 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 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:
One bar lit Upper limit light on Solid white Solid green Slowly dimming and brightening green Means:
Stimulation strength is at minimum and may not be decreased Stimulation strength is at maximum and may not be increased Therapy is off Therapy is on and stimulation is active Therapy is on and stimulation is paused Inspire Sleep Remote English 19 200-161-101 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 Generator light Sleep remote battery light 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. 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 light:
Both status lights off Sleep remote battery light on Means:
Sleep remote and generator are operating normally Sleep remote batteries are low and need to be changed Generator light on Contact your doctor Both status lights on Generator light flashing 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. Communication with your generator has been interrupted by electromagnetic interference. Move away from potential sources of interference, and try again. Inspire Sleep Remote English 21 200-161-101 Rev A
1 | User Manual Part 2 | Users Manual | 5.48 MiB | November 01 2016 / September 07 2016 |
3032PatEN_ch4.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Audio Tones When audio tones are turned on, the sleep remote beeps when a change to the therapy settings is successfully completed. Audio tone: Means:
Your change was successful. Two beeps with a rising tone Three rapid beeps Six rapid beeps Your change was not successful, because the sleep remote was unable to communicate with your generator. Try the change again. (For instructions on positioning your sleep remote, refer to page 24.) You tried to increase the stimulation strength outside the range set by your doctor, and you have reached the upper limit. (For instructions on increasing your stimulation strength, refer to page 32.) You tried to decrease the stimulation strength outside the range set by your doctor, and you have reached the lower limit. (For instructions on decreasing your stimulation strength, refer to page 33.) Communication with your generator was interrupted by electromagnetic interference. Move away from potential sources of interference, and try again. 22 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 Turning Audio Tones On or Off Your sleep remote audio tones can be turned on or off. Inspire recommends that you keep audio tones on. Turning audio tones on or off:
1. Remove the battery compartment cover. (For instructions, refer to page 41.) 2. Push the audio tones switch up to turn the audio tones on
) and down to turn the audio tones off (
)
(
(Figure 10). On Audio tones switch Off Do not connect anything to this port Figure 10. Turning audio tones on or off 3. Replace the battery compartment cover. (For instructions, refer to page 42.) Inspire Sleep Remote English 23 200-161-101 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 Using Your Inspire Sleep Remote Positioning Your Sleep Remote The sleep remote communicates with your generator by sending and receiving short range radio signals. To communicate with your generator, you must place the sleep remote Therapy On button (
) directly over your generator immediately after you press a button (Figure 11). The sleep remote attempts to communicate with your generator for 10 seconds. If communication is not successful after 10 seconds the sleep remote beeps rapidly three times and the sleep remote light indicate the therapy status for several seconds. Sleep remote Radio signals Generator Figure 11. Communication between sleep remote and generator 24 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 To position your sleep remote for communication with your generator:
1. Press a button. The therapy status light flashes to indicate the change is in progress. 2. Position the sleep remote over your generator and against your body. The buttons should face away from your body (Figure 12). Figure 12. Correct positioning of sleep remote over generator 3. Adjust the sleep remote position until the Therapy On button (
) is directly over your generator. 4. Slowly adjust the sleep remote position until you hear a tone or 10 seconds pass. 5. Remove the sleep remote from your body and review the sleep remote lights to confirm that the change was communicated to your generator. Note: If you hear three rapid beeps, or the change you want is not indicated by the sleep remote lights, then try communicating with your generator again. Inspire Sleep Remote English 25 200-161-101 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 If you are having trouble positioning the sleep remote:
Note: These steps turn therapy off. 1. Make sure the audio tones are on. (For instructions on turning audio tones on and off, refer to page 23.) 2. Press the Therapy Off button (
3. Position the sleep remote directly over your generator and against your body. The buttons should face away from your body (Figure 12).
). 4. Adjust the sleep remote position until the Therapy On button (
) is directly over your generator. 5. Wait until you hear a tone or 10 seconds pass. 6. Remove the sleep remote from your body and review the sleep remote lights to confirm that the change was communicated to your generator. Notes:
If you hear three rapid beeps, or the change you want is not indicated by the sleep remote lights, then try communicating with your generator again. The sleep remote communicates one change at a time. If you press an incorrect button, wait for 10 seconds until the sleep remote stops attempting to communicate with the generator, and then press the correct button. Pressing the Therapy Off button (
) cancels communication in progress. The sleep remote then attempts to turn your generator off. 26 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 Communicating with your Generator When the sleep remote is communicating with your generator, the status ring and stimulation strength gauge blink on and off. The blinking lights indicate the change the sleep remote is attempting to make to your generator. Status ring Figure 13. Status ring Status ring:
Whole ring blinking white Whole ring blinking green Top of ring blinking Bottom of ring blinking Means:
Turning therapy off Turning therapy on or pausing therapy Increasing stimulation strength Decreasing stimulation strength Inspire Sleep Remote English 27 200-161-101 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 Stimulation strength gauge Figure 14. Stimulation strength gauge Stimulation strength gauge:
Whole gauge blinking white Whole gauge blinking green One step on the gauge is blinking Means:
Turning therapy off Turning therapy on or pausing therapy Increasing or decreasing stimulation strength. The newly selected stimulation strength step is blinking. 28 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 Turning Therapy On It is recommended that you turn therapy on as part of your bedtime routine. Immediately after turning therapy on, you will feel a short stimulation. After that initial stimulation, therapy is delayed so you have time to fall asleep. To turn your therapy on:
1. Press the Therapy On button (
2. Position the sleep remote over your generator and
). against your body with the buttons facing away from your body (Figure 15). Figure 15. Correct positioning of sleep remote over generator 3. Wait until you hear a tone or 10 seconds pass. 4. Check the status ring. If the status ring is solid green or is slowly dimming and brightening green, therapy is on. The sleep remote lights stay on for several seconds after communicating with the generator. Inspire Sleep Remote English 29 200-161-101 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 If the sleep remote lights are off, gently shake the remote and the lights turn on. Note: When you turn stimulation on, you will feel one short stimulation, and then your generator will delay further stimulation while you fall asleep. Your doctor sets the length of this Start Delay time for your generator. Turning Therapy Off Always turn therapy off when you are not sleeping. Leaving therapy on reduces generator battery life and increases the likelihood of unwanted stimulation. To turn your therapy off:
1. Press the Therapy Off button (
2. Position the sleep remote over your generator and
). against your body with the buttons facing away from your body (Figure 15). 3. Wait until you hear a tone or 10 seconds pass. 4. Check the status ring. If the status ring is a solid white, therapy is off. The light stays on for several seconds after communicating with the generator. If the sleep remote lights are off, gently shake the remote and the lights will turn on. Note: Pressing the Therapy Off button (
communication in progress. The sleep remote then attempts to turn your generator off.
) cancels 30 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 Pausing Therapy If you wake with your therapy on, and you intend to go back to sleep, you can pause therapy instead of turning therapy off. The length of time that the therapy pauses is set by your doctor. Therapy Pause and Start Delay are different. Start Delay begins automatically when you turn therapy on. When therapy is on, Therapy Pause begins when you press the Therapy On button (
To pause therapy:
1. Press the Therapy On button (
2. Position the sleep remote directly over your generator
).
). and against your body with the buttons facing away from your body (Figure 15). 3. Wait until you hear a tone or 10 seconds pass. 4. Check the status ring. If the status ring is slowly dimming and brightening green, therapy is paused. The status ring stays lit for several seconds after communication with the generator. If the sleep remote lights are off, gently shake the remote and the lights will turn on. Inspire Sleep Remote English 31 200-161-101 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 Increasing Stimulation Strength The sleep remote allows you to increase stimulation strength within a range set by your doctor. If you feel little or no stimulation, you can increase (
) the stimulation. Stimulation can be increased when therapy is on or off. The stimulation strength gauge on the back of the sleep remote indicates the current stimulation strength and the upper limit light (
highest stimulation strength allowed by your doctor. (For information on the stimulation strength gauge and upper limit, refer to page 18.) Contact your doctor if you cant achieve the desired stimulation strength. To test the current stimulation strength:
1. Turn therapy off by pressing the Therapy Off button (
) indicates when you have reached the
) and positioning the sleep remote over your generator. 2. Wait until you hear a tone or 10 seconds pass. 3. Turn therapy on by pressing the Therapy On button (
and positioning the sleep remote over your generator.
) 4. Wait until you hear a tone or 10 seconds pass. 5. You will receive one short stimulation immediately when therapy is turned on. 32 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 To increase stimulation strength:
1. Press the Increase button (
). Note: If the sleep remote beeps rapidly three times, and the upper limit light (
) on the back of the remote is on, you have reached the upper limit. 2. Position the sleep remote directly over your generator and against your body with the buttons facing away from your body (Figure 15). 3. Wait until you hear a tone or 10 seconds pass. 4. To test the new stimulation strength:
a.Turn therapy off. b.Turn therapy on. You will receive one short stimulation immediately when therapy is turned on. Decreasing Stimulation Strength The sleep remote allows you to decrease the stimulation strength within a range set by your doctor. If stimulation feels too strong, you may want to decrease (
) the stimulation strength. Stimulation strength can be decreased with therapy on or off. The stimulation strength gauge on the back of the sleep remote indicates the current stimulation strength. If only one bar on the gauge is lit, then stimulation strength is at the lowest allowed setting. (For information on the stimulation strength gauge, refer to page 18.) Contact your doctor if you cant achieve the desired stimulation strength. Inspire Sleep Remote English 33 200-161-101 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 To test the current stimulation strength:
1. Turn therapy off by pressing the Therapy Off button (
and positioning the sleep remote over your generator. 2. Wait until you hear a tone or 10 seconds pass. 3. Turn therapy on by pressing the Therapy On button (
and positioning the sleep remote over your generator.
)
) 4. Wait until you hear a tone or 10 seconds pass. 5. You will receive one short stimulation immediately when therapy is turned on. To decrease stimulation strength:
1. Press the Decrease button (
) to adjust your stimulation strength. Note: If the sleep remote beeps rapidly three times, and only one bar on the stimulation strength gauge is on, you have reached the lower limit. 2. Position the sleep remote directly over your generator and against your body with the buttons facing away from your body (Figure 15). 3. Wait until you hear a tone or 10 seconds pass. 4. To test the new stimulation strength:
a.Turn therapy off. b.Turn therapy on. You will receive one short stimulation immediately when therapy is turned on. 34 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch5.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 5. Living with Your Inspire System Activities and Exercise On the advice of your doctor, and as you begin to feel better after your surgery, you can gradually resume your normal lifestyle. Returning to your daily activities should make you feel better, not worse. It is important that you follow your doctor's advice. Ask your doctor about strenuous activities, such as lifting heavy objects. Caution: For several weeks after the implant procedure, avoid sudden, excessive, or repetitive bending, twisting, bouncing, or stretching. These types of activities could affect your healing process and cause you discomfort. Travel Information As you travel, your sleep remote will allow you to operate your generator at any travel destination while you sleep. It is possible that airport security devices may affect the operation of your generator and detect the metal in your Inspire Sleep Remote English 35 200-161-101 Rev A 3032PatEN_ch5.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 generator. Always tell security staff that you have an implanted generator and carry your Inspire Identification Card for verification. This also applies if you encounter similar security devices in other situations. For detailed instructions about how to interact with security devices, refer to "Theft Detector or Security Screening Devices" on page 9. When to Call Your Doctor Call your doctor if:
You experience anything unusual, such as new, unexplained symptoms. You notice signs of infection such as redness and swelling near an implant site. You notice that the stimulation begins to feel different or becomes uncomfortable. Turn the therapy off first, then call. You are not getting adequate stimulation. The location of your stimulation has dramatically changed. This could result from movement of the stimulation lead. The generator light on the back of your sleep remote is on. If you are unable to reach your doctor immediately, try again at a later time. Meanwhile, discontinue therapy and contact the doctor who implanted your system. 36 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch5.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Manufacturer's Information Your primary resource for all questions and requests is your doctor. As an additional resource, you may contact Inspire Medical Systems, Inc:
Address: 9700 63rd Ave N, Maple Grove, MN 55369 Phone: 763-205-7970 or 1-844-672-4357 Toll Free Website: www.inspiresleep.com Inspire Sleep Remote English 37 200-161-101 Rev A 3032PatEN_ch5.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 38 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 6. Maintaining Your Inspire Sleep Remote You will need to replace your sleep remote batteries and clean the sleep remote as needed. Although your doctor will monitor your generator battery status during your follow-up appointments, you can also use your sleep remote to check your generator battery status. Sleep Remote Batteries Warning: The sleep remote batteries may pose a choking hazard. Keep the sleep remote and batteries away from children and pets. The sleep remote uses two AAA or LR03 alkaline batteries. Replace the batteries when the sleep remote battery light is on or after 4 months of use. Inspire Sleep Remote English 39 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Cautions:
Do not use rechargeable batteries in the sleep remote. Rechargeable batteries may cause the sleep remote to not function properly. Do not leave batteries in the sleep remote if it will not be used for more than 4 weeks. Batteries left in the sleep remote may corrode and damage the sleep remote. Checking the Sleep Remote Battery Status Develop a routine where you check your sleep remote battery status regularly. Inspire recommends checking the sleep remote batteries each morning after you turn therapy off. To check the sleep remote battery status:
1. Pick up or gently shake the sleep remote. 2. Check the sleep remote battery light (
) on the back of your sleep remote If the light is on, replace the sleep remote batteries. If the light is off, the batteries are good. 40 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Replacing the Sleep Remote Batteries The sleep remote batteries are located in a battery compartment on the bottom of the sleep remote. To remove the battery compartment cover:
1. Hold the sleep remote with the battery compartment cover facing upwards as shown in Figure 16. Figure 16. Removing the battery compartment cover 2. Push gently and firmly upward on the release tab at the end of the sleep remote. 3. Gently rotate the cover upwards. Inspire Sleep Remote English 41 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 To replace the sleep remote batteries:
1. Insert your finger in the finger hole to loosen the first battery, and then gently remove the batteries. 2. Position each battery to match the figure in the battery compartment (Figure 17). Do not connect anything to this port Finger hole Figure 17. Batterycompartmentandbatteryplacement To close the battery compartment:
1. Insert the battery door tabs into the two slots located above the batteries. 2. Gently lower the battery compartment cover. 3. Gently press down on the end of the battery compartment cover to lock it in place. 4. Inspect the battery door to make sure it is properly closed. 42 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Battery and Sleep Remote Disposal Dispose of depleted batteries and a worn out sleep remote according to local requirements. If desired, remove the batteries and return the sleep remote to Inspire for disposal. Cleaning Your Sleep Remote Clean the outside of the sleep remote with a slightly damp cloth. The sleep remote is not sterile and is not intended to be sterilized. Diluted mild household detergents will not damage the sleep remote. Cautions:
Avoid getting the sleep remote wet. Your sleep remote is water-resistant, not waterproof, and exposure to water or other liquids could damage the sleep remote. Do not use corrosive liquids to clean your sleep remote
(eg, bleach, nail polish remover). Corrosive liquids could damage the external housing of the sleep remote. Inspire Sleep Remote English 43 200-161-101 Rev A 3032PatEN_ch6.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Handling Your Sleep Remote The sleep remote should be handled with care. Caution:
Handle your sleep remote with care. Mishandling the sleep remote can damage the sleep remote. Do not drop the sleep remote. Protect the sleep remote against sharp blows and physical shocks. Do not disassemble or tamper with the internal components of the sleep remote. Accessing the internal components could affect the performance of the sleep remote and void the warranty. Checking the Generator Battery Status You can check your generator battery status. If your generator battery is low, your generator will need to be replaced. To check the generator battery status:
1. Pick up or gently shake the sleep remote. 2. Check the generator light (
remote. If the light is on, contact your doctor.
) on the back of your sleep 44 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 7. Troubleshooting Your Sleep Remote The following table provides possible solutions to common questions that may arise when using your sleep remote. If you need further assistance in setting up, using, or maintaining your sleep remote, or to report problems with your sleep remote, contact your doctor or Inspire Medical Systems, Inc. For contact information, refer to Manufacturer's Information on page 37. If this happens: Possible causes:
A status light on Turn the sleep remote over Try these steps:
on the back of the sleep remote is on. and view the status lights. For information on status lights, refer to page 20. For information on status lights, refer to page 20. Inspire Sleep Remote English 45 Yellow bars are flashing left and right on the front of your sleep remote. A yellow light
(
back of your sleep remote is on.
) on the or 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 If this happens: Possible causes:
Sunlight may obscure your view of the sleep remote lights. No batteries, No lights turn on after you press a button. depleted batteries, or a battery is placed backwards in the battery compartment. Try these steps:
If you are outdoors, move indoors or use your sleep remote in the shade. Check the orientation of the batteries. If the batteries are oriented correctly, replace with new batteries (refer to page 39). If the problem persists, call your doctor.
) on the Both status lights
(
back of the sleep remote are on, and the sleep remote does not work. You want to check your generator battery without making any other changes. The sleep remote batteries may be very low and need to be replaced. Replace the sleep remote batteries with new batteries. Make sure that you are not pressing any buttons while inserting batteries. The sleep remote may not be operating properly. For information on status lights, refer to page 20. If all the lights stay on, call your doctor. Pick up or gently shake the sleep remote to display the battery status. If the generator status light (
generator battery is good
(refer to page 44).
) is off, your 46 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 If this happens: Possible causes:
Audio tones are turned off. Try these steps:
Turn audio tones on (refer to page 23). You do not hear audio tones, but the sleep remote is working. You hear three beeps after pressing the Increase (
) or Decrease button
(
You hear three beeps several seconds after pressing a button.
). Stimulation is uncomfortable. The stimulation strength is at the upper or lower limit. Confirm that the current stimulation strength does not work for you. Contact your doctor to change the stimulation strength limits. A setting in your generator has changed. Review current therapy settings and try your change again. Communication with your generator was not successful. 1. Press the Therapy Off button
(
). 2. Reduce the stimulation strength by pressing the Decrease button (
then holding the sleep remote over your generator. 3. Press the Therapy On button
), and
) to test the stimulation
(
strength. Decrease stimulation further if necessary (refer to page 33). Inspire Sleep Remote English 47 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 If this happens: Possible causes:
Try these steps:
Stimulation is too strong. Stimulation is not strong enough. You feel that a change took place after you pressed a button, but the sleep remote lights did not change. Decrease stimulation (refer to page 33). Increase stimulation (refer to page 32). Hold the sleep remote closer to your generator. Review the positioning instructions on page 24. Try your change again. Turn off or move away from other electronic devices. Try your change again. The sleep remote was too far from the generator. (The generator may have received the sleep remote signal, but the sleep remote did not receive the generator confirmation signal.) An electronic device interfered with communication between your sleep remote and generator. 48 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 If this happens: Possible causes:
Therapy may not have turned on. You do not feel stimulation immediately when turning therapy on. Your stimulation may be delayed or paused. The stimulation strength may be set too low. Your generator may need attention from your doctor. Try these steps:
Pick up or gently shake the sleep remote to check therapy status. If the status ring is white, therapy is off. Turn therapy on again. Pick up or gently shake the sleep remote to check therapy status. If the status ring is slowly dimming and brightening green, therapy is on and stimulation is paused. Stimulation will automatically start after the Start Delay or pause time. Pick up or gently shake the sleep remote to check therapy status. If the status ring is solid green, stimulation is on. You may want to increase the stimulation strength (refer to page 32). If you still do not feel stimulation, contact your doctor. Pick up or gently shake the sleep remote. If the generator status light (
) on the back of the sleep remote is on, contact your doctor. Inspire Sleep Remote English 49 200-161-101 Rev A 3032PatEN_ch7.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Try these steps:
Press the Therapy Off button
(
) and wait 10 seconds. If the remote lights do not turn on, replace the remote batteries (refer to page 39). 1. Immediately remove the sleep remote from the water. 2. Dry the sleep remote with a towel. 3. Remove the batteries and dry the battery compartment if needed. 4. Allow the battery compartment to air dry at room temperature for at least 24 hours. 5. Insert new batteries. The sleep remote is designed to withstand a short drop and still operate normally, even if the case is chipped or otherwise damaged. Your sleep remote lights do not turn on when it is gently shaken. If this happens: Possible causes:
Your sleep remote may have been excessively bounced during the previous 30 minutes and has temporarily disabled motion sensing to save battery life. Your sleep remote falls into water. Your sleep remote falls off a cabinet or table. 50 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch8.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 8. Specifications If the sleep remote has been stored at high or low temperatures, store the sleep remote at room temperature for one hour before use. This will allow the remote to return to normal operating temperature. Inspire Sleep Remote Power source Operating temperature 2 AAA or LR03 alkaline batteries 5 40C 41 104F
-25 70C
-13 158F 15 90%
up to 90%
700 hPa 1060 hPa (20.7 Hg 31.3 Hg) Storage temperature
(inside or outside of packaging) Operating humidity Storage humidity Operating/storage atmospheric pressure Protection against electric shock Internally powered equipment Battery life of sleep remote batteries Expected service life of sleep remote 5-year expected (minimum) life 2 months (average) Inspire Sleep Remote English 51 200-161-101 Rev A 3032PatEN_ch8.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Connections to Additional Equipment Anybody connecting additional equipment to medical electrical equipment configures a medical system and is responsible that the system complies with the requirements for medical electrical systems. Additional equipment connected to the sleep remote must comply with the respective IEC or ISO standards (for example IEC 60950 for data processing equipment such as personal computers). All configurations must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Local laws take priority over the requirements of this section. Contact your doctor or Inspire for additional information. Do Not Modify Do not modify the sleep remote. Changes or modifications could void the user's authority to operate the equipment. FCC Statements This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and 52 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_ch8.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Inspire Sleep Remote English 53 200-161-101 Rev A 3032PatEN_ch8.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 54 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_Warranty.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Inspire Medical Systems Limited Warranty Summary Inspire provides a limited warranty against defects. The warranty period for implanted products is 3 years. All other products have a warranty period of 1 year. The warranty information below is intended for doctors (referred to as physicians in the warranty), but is included here for reference. Ask your doctor if you have any questions. The information below takes precedence over the information contained in this Summary. Inspire Medical Systems' products consist of Implantable Pulse Generators (IPG), tools to connect the IPG to implantable leads, leads, Inspire Sleep Remotes, and physician programmers. 1. EXCLUSION OF WARRANTIES, NO WARRANTIES FOR TOOLS. The implied warranties of MERCHANTABILITY and fitness for a particular purpose and all other warranties, express or implied with regard to tools are EXCLUDED from any transaction and shall not apply. Inspire Medical Systems will not be liable for any damages, whether direct, consequential, or incidental caused by tool defects, failures, or malfunctions, whether such claims are based on warranty, contract, tort or otherwise. No person has any authority to bind Inspire Medical Systems to any representation or warranty with respect to tools. You may have other rights, which vary from state to state. If one or more of the provisions of this exclusion of warranties for tools shall be deemed void or unenforceable, the remaining provisions shall continue to have full force and effect. 2. LIMITED WARRANTY FOR PRODUCTS OTHER THAN TOOLS. This limited warranty is available if products other than tools fail to function within normal tolerances due to defects in materials or workmanship that manifest during the specified warranty period. Inspire Sleep Remote English 55 200-161-101 Rev A 3032PatEN_Warranty.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 During the operational life of an IPG, battery energy is consumed to monitor the patient's breathing and provide therapy. On the basis of individual patient physiology, certain patients may require more frequent therapy, thus requiring replacement of the IPG in less than the warranty period shown below. This is considered normal for those patients and not a malfunction or defect in the IPG. If the purchaser complies with the Terms and Conditions, Inspire Medical Systems will issue a limited warranty toward the purchase of a new Inspire Medical Systems IPG product. The limited warranty credit amount will be the full purchase price of either the original unit or the replacement unit, whichever is less. For patient products, for example, IPG, lead, Inspire Sleep Remote, Inspire Medical Systems will issue a credit to the hospital conducting replacement surgery on behalf of the original patient. Any cost reductions extended as a result of this warranty shall be fully and accurately reflected on the patients' bill and reported to that applicable payor using the appropriate methodology. For physician products, for example, physician programmer, Inspire Medical Systems will issue a credit to the original purchaser of the product. A. Terms and Conditions 1. The product labeling must indicate a limited warranty exists. 2. For implantable products, this limited warranty applies only for a product replacement in the original patient. 3. All registration materials must be completed and returned to Inspire Medical Systems within 30 days of first use. 4. The product must be replaced with an Inspire Medical Systems product. 5. If the product is implantable, it must be implanted before the product expires and implanted with other Inspire Medical Systems products. 56 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_Warranty.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 6. The product must be returned to Inspire Medical Systems, 9700 63rd Avenue North Maple Grove, MN 55369 within 30 days that the product first fails to function within normal tolerances. The product may be returned at no cost to you. Contact your Inspire Medical Systems representative for information on how to return the product. 7. Inspire Medical Systems will inspect the returned product and determine whether a limited warranty credit is due. 8. All products returned to Inspire Medical Systems become its property. This limited warranty represents the entire obligation of Inspire Medical Systems for products other than tools and is made IN LIEU OF any other warranties, whether express or implied, including MERCHANTABILITY or fitness for a particular purpose. Inspire Medical Systems will not be liable for any damages, whether direct, consequential, or incidental caused by product defects, failures, or malfunctions, whether such claims are based on warranty, contract, tort or otherwise. No person has any authority to bind Inspire Medical Systems to any warranty or representation except those specifically contained herein. This limited warranty gives specific legal rights, and you may also have other rights, which vary from state to state. If one or more of the provisions of this limited warranty shall be deemed void or unenforceable, the remaining provisions shall continue to have full force and effect. B. Limited Warranty Period The applicable limited warranty period for each product is listed and calculated as follows:
1. Three (3) years from date an IPG or lead is implanted in the patient. 2. One (1) year from the date a physician or Inspire Sleep Remote is first used. Inspire Sleep Remote English 57 200-161-101 Rev A 3032PatEN_Warranty.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 58 English Inspire Sleep Remote 200-161-101 Rev A 3032PatEN_MLbcv.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 200-161-101 Rev A 3032PatEN_MLbcv.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical Confidential Inspire 002 Manufacturer Inspire Medical Systems, Inc. 9700 63rd Avenue North Maple Grove, MN 55369 USA Tel. 1-844-672-4357 Toll Free or 763-205-7970 Fax 763-537-4310 www.inspiresleep.com HealthLink Europe Services BV De Tweeling 20-22 5215 MC s-Hertogenbosch The Netherlands Tel. +31.13.5479300 Attn: Quality Department Inspire Medical Systems 2015 All Rights Reserved 200-161-101 Rev A 200-161-101 Rev A
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2016-01-11 | 0.175 ~ 0.175 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2016-01-11
|
||||
1 | Applicant's complete, legal business name |
Inspire Medical Systems, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0025086356
|
||||
1 | Physical Address |
5500 Wayzata Blvd
|
||||
1 |
Golden Valley, Minnesota 55416
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
V******@tuvam.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AGO2
|
||||
1 | Equipment Product Code |
2500
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D**** D******
|
||||
1 | Title |
Program Director
|
||||
1 | Telephone Number |
763-2********
|
||||
1 | Fax Number |
763-5********
|
||||
1 |
d******@inspiresleep.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 07/09/2016 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Patient Programmer for IPG | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
TUV SUD America Inc.
|
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1 | Name |
W**** E********
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1 | Telephone Number |
813 2********
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1 | Fax Number |
978 9********
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1 |
b******@tuvam.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 0.17500000 | 0.17500000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC