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1 2 | User Manual | Users Manual | 1.33 MiB | July 13 2021 / January 09 2022 | delayed release |
200-423-001_Rev A_2580 Manual US.book Page 1 INSPIRE SLEEP REMOTE Inspire Sleep Remote Model 2580 Rx Only 200-423-001_Rev A_2580 Manual US.book Page 2 The following is a registered trademark of Inspire Medical Systems, Inc.: Inspire The following is a trademark of Inspire Medical Systems, Inc.: Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page i Explanation of Symbols on Sleep Remote or Package Turn therapy on button; or, if therapy is already on, then push to pause therapy Turn therapy off button Decrease stimulation strength button Increase stimulation strength button Replace sleep remote batteries status light Generator battery may be low status light Communication with your generator has been interrupted due to Electromagnetic Interference (EMI) status light Bluetooth pairing is in process status light Stimulation strength is at the upper limit status light Inspire Sleep Remote English i 200-423-001_Rev A_2580 Manual US.book Page ii Consult instructions for use Reference number Serial number IEC 60601-1/EN60601-1, Type BF Equipment This symbol means that the device comes into contact with the patient Keep dry, use caution to prevent spilling or splashing liquids on the sleep remote Manufacturer Date of manufacture MRI unsafe Temperature limitation Atmospheric pressure limitation Relative humidity limitation 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 40 for more detailed information. ii English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page iii Inspire Sleep RemoteTM Quick Guide Therapy On Pause Decrease (stimulation strength) Status ring Increase (stimulation strength) Therapy Off Figure 1. Sleep remote front view White Green Solid Status Ring Therapy is off Therapy is on and stimulation is on Green Dimming and brightening Therapy is on, stimulation is paused Turning Therapy On Press the Therapy On (
) button and hold the sleep remote over your generator for 10 seconds or until the sleep remote produces an audio tone. When therapy is turned on, the generator will produce a brief stimulation pulse. Inspire Sleep Remote English iii 200-423-001_Rev A_2580 Manual US.book Page iv Turning Therapy Off Press the Therapy Off button (
) and hold the sleep remote over your generator for 10 seconds or until the sleep remote produces an audio tone. Note: Removing the batteries from your sleep remote will not turn off the therapy. Decreasing Stimulation Strength Press the Decrease button (
) and hold the sleep remote over your generator for 10 seconds. When audio is enabled, the sleep remote will produce an audio tone when you decrease stimulation. If the stimulation strength is at the lower limit when you press
) and audio is enabled, the remote the Decrease button (
will immediately emit three beeps. Increasing Stimulation Strength Press the Increase button (
) and hold the sleep remote over your generator for 10 seconds. When audio is enabled, the sleep remote will produce an audio tone when you increase stimulation. If the stimulation strength is at the upper limit when you press the Increase button (
will immediately emit three beefs.
) and audio is enabled, the remote Pausing Therapy While therapy is on, press the Therapy On button (
) and hold the sleep remote over your generator for 10 seconds or until the sleep remote produces an audio tone. iv English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page v Stimulation strength gauge Generator light Bluetooth EMI Upper limit light Sleep remote battery light Figure 2. Sleep remote back view Status Indicators Replace sleep remote batteries If the light is on, your generator battery may be low or therapy disabled, call your doctor If the light is on and flashing, communication with your generator has been interrupted due to Electromagnetic Interference (EMI). Refer to Interference on page 8. Stimulation strength is at the upper limit Stimulation strength gauge Bluetooth pairing is in process Inspire Sleep Remote English v 200-423-001_Rev A_2580 Manual US.book Page vi Finding the Generator Press the Therapy Off button (
) and move the sleep remote near your generator. When the sleep remote produces two beeps, with the second beep at a higher tone than the first, you have found the generator location. If the sleep remote produces three rapid beeps, you have not found the generator location. Try again. Two beeps with the second beep at a higher tone than the first Three rapid beeps Two beeps that repeat 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 Sleep remote is updating the generator Wait until complete, when the success tone is played Update may take several seconds vi English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page vii Table of Contents Explanation of Symbols on Product or Package i Inspire Sleep RemoteTM Quick Guide iii Glossary ix 1. Introduction 1 About This Manual 2 Package Contents 2 2. Inspire Therapy 3 Your Inspire System 3 Therapy Summary 4 3. Safety Information 7 Warnings 7 Precautions 8 System and Therapy 8 Patient Activities 8 Interference 8 Additional Therapy Information 5 Frequently Asked Therapy Questions 5 4. Using Your Sleep Remote 11 Sleep Remote Buttons 12 Status Ring 13 Stimulation Strength Gauge 14 Status Lights 16 Bluetooth Pairing with a Mobile Phone 18 Using Your Inspire Sleep Remote 21 Positioning Your Sleep Remote 21 Inspire Sleep Remote English vii 200-423-001_Rev A_2580 Manual US.book Page viii Communicating with your Generator 24 Turning Therapy On 26 Turning Therapy Off 27 Pausing Therapy 28 Increasing Stimulation Strength 29 Decreasing Stimulation Strength 30 5. Living with Your Inspire System 33 Travel Information 33 When to Call Your Doctor 33 Manufacturer's Information 34 6. Maintaining Your Inspire Sleep Remote 35 Sleep Remote Batteries 35 Checking the Sleep Remote Battery Status 36 Replacing the Sleep Remote Batteries 37 Battery and Sleep Remote Disposal 40 Cleaning Your Sleep Remote 40 Handling Your Sleep Remote 41 Checking the Sleep Remote 41 Checking the Generator Battery Status 42 7. Troubleshooting Your Sleep Remote 43 8. Specifications 51 Connections to Additional Equipment 52 Do Not Modify 52 FCC Statements 52 Inspire Medical Systems Limited Warranty 55 viii English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page ix Glossary Apnea A temporary absence of breathing. Caution A statement describing actions that could result in minor or moderate injury to the patient, device damage, or improper functioning of a device. Contraindication A condition or circumstance when a person should not have an Inspire system. Generator The implanted component of the Inspire system that contains the battery and electronics that control stimulation. Your doctor may also refer to your generator as an IPG or implantable pulse generator. Hypoglossal Nerve The nerve that controls tongue movement. 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. Inspire Sleep Remote English ix 200-423-001_Rev A_2580 Manual US.book Page x Start Delay A delay between when the therapy is turned on and when the stimulation begins. Start Delay allows the patient to fall asleep before stimulation begins. Stimulation The delivery of electrical pulses to the nerve that controls tongue movement (see Hypoglossal Nerve). Stimulation Strength The stimulation level (amplitude) measured in volts. Therapy Treatment of a disease or condition. The Inspire system uses stimulation to provide therapy. Therapy Settings The settings, stored in the generator, that define the therapy you receive. Upper Airway The breathing path from the mouth and nostrils to the larynx (voice box). Warning A statement describing an action or situation that could seriously harm the patient. x English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 1 1. Introduction You have received an Inspire system to deliver Inspire Upper Airway Stimulation (UAS) therapy (Figure 3a). Your doctor has given you an Inspire Sleep RemoteTM (Figure 3b). Use your sleep remote to turn your therapy on and off and adjust the strength of stimulation. Implanted components Inspire Sleep Remote a b Figure 3. Inspire system Inspire Sleep Remote English 1 200-423-001_Rev A_2580 Manual US.book Page 2 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 AA or LR6 alkaline batteries Sleep Remote Manual and Quick Guide Sleep Remote carrying case 2 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 3 2. Inspire Therapy You have received an Inspire system to deliver Inspire Upper Airway Stimulation (UAS) therapy. Your doctor prescribed UAS therapy to treat your sleep apnea. For more information about your Inspire system, refer to your Inspire Patient Manual. Your Inspire System Stimulation lead Generator Respiratory sensing lead Figure 4. Implanted components of the Inspire system Inspire Sleep Remote English 3 200-423-001_Rev A_2580 Manual US.book Page 4 The implanted components of the Inspire system (Figure 4) are a generator, a stimulation lead, and a respiratory sensing lead. For more detailed information about each component, refer to your Inspire Patient Manual or contact your doctor. Generator Contains the battery and electronics that provide stimulation. Respiratory sensing lead When therapy is on, this lead monitors your breathing. Stimulation lead When therapy is on, this lead delivers stimulation to activate the muscles in your upper airway. The external components of the Inspire system are:
Sleep remote That you use to control your implanted Physician programmer That your doctor uses to program system. your therapy settings. Therapy Summary Inspire therapy is only used when you are sleeping. You will turn your therapy off during the day. When you are preparing to go to sleep, you will use your sleep remote to turn your therapy on. You will feel a brief stimulation confirming that therapy has been turned on. After the confirmation, stimulation is delayed so you have time to fall asleep. When the delay time has passed, the Inspire system delivers mild stimulation to the nerve that controls your tongue movement 4 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 5
(the hypoglossal nerve) as it senses breathing. The stimulation causes the upper airway muscles to stiffen, preventing airway blockages. The therapy does not wait for an apnea to occur before delivering stimulation. Stimulation is delivered throughout the night to prevent apneas. Additional Therapy Information For additional information, such as therapy indications, contraindications, risks, benefits, and surgical procedure description, refer to your Inspire Patient Manual. Frequently Asked Therapy Questions What does stimulation feel like?
Most patients report that stimulation is a mild sensation. Stimulation results in an involuntary movement of the upper airway muscles and/or tongue. If the stimulation strength is too high, the upper airway may have a strong response that may be uncomfortable. Stimulation strength can be adjusted so that therapy is comfortable and effective. Will I feel anything when I turn therapy on?
Yes. When therapy is turned on you should feel a brief stimulation for a few seconds. Then stimulation is delayed for a period of time while you fall asleep. After this Start Delay, stimulation resumes. Inspire Sleep Remote English 5 200-423-001_Rev A_2580 Manual US.book Page 6 6 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 7 3. Safety Information The following warnings and precautions are in regard to the sleep remote. For additional warnings and precautions regarding Inspire therapy overall, refer to your Inspire Patient Manual. The Inspire Patient Manual includes safety information about medical procedures, equipment, devices, and activities that could interfere with the function of your Inspire system. If you need another Inspire Patient Manual, please contact your doctor or Inspire Medical Systems Inc. to request a replacement. Warnings Choking hazard. The sleep remote batteries may pose a choking hazard. Keep the sleep remote and batteries away from children and pets. 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. Inspire Sleep Remote English 7 200-423-001_Rev A_2580 Manual US.book Page 8 Precautions 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. Keep the sleep remote dry. Keep the sleep remote away from sources of water and condensation such as sinks and humidifiers. Failure to keep the sleep remote dry 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. Children or pets may damage the sleep remote. Interference Any electric device could be a potential source of interference with the communication between your remote and your generator. See below for typical examples of equipment in your 8 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 9 home that may cause interference and recommendations helping to prevent interference with the communication between your remote and your generator. Equipment:
Recommendations:
Home wireless products such as:
Wireless Qi chargers Wi-Fi networking devices Walkie-talkies Laptop Computers Tablets Mobile/cell phones Home electromagnetic devices such as:
Electric and magnetic blankets Electric and magnetic pillows Wearable electromagnetic devices Keep 3 feet (1 meter) away from home wireless devices when using your sleep remote. Note: Your sleep remote is designed to communicate with mobile/cell phones using Bluetooth Low Energy; however, using your phone simultaneously with your patient remote may interfere with communication with your generator. Keep 1 foot (0.3 meters) away from home electromagnetic devices when using your sleep remote. Inspire Sleep Remote English 9 200-423-001_Rev A_2580 Manual US.book Page 10 10 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 11 4. Using Your Sleep Remote Your sleep remote allows you to turn your therapy on before you go to sleep, off during waking hours, and pause therapy if you wake and need time to fall back to sleep. It also allows you to adjust the stimulation strength within a range determined by your doctor. You also use your sleep remote to check the status of your generator battery. The sleep remote communicates with your generator by sending and receiving short range radio signals to and from your generator. To communicate with your generator, the sleep remote Therapy On button (
) must be held directly over your generator and facing away from you as shown below (Figure 5). Generator Radio signals Sleep remote Figure 5. Communication between sleep remote and generator Inspire Sleep Remote English 11 200-423-001_Rev A_2580 Manual US.book Page 12 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 12 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 13 Status Ring Status ring Figure 7. Status ring The sleep remote has a status ring (Figure 7) around the Therapy On button (
). The status ring lights up and indicates if therapy is on, off, or paused. To check your therapy status:
Pick up or gently shake the sleep remote. The status ring lights up to indicate your therapy status. Status ring light:
Means:
Solid white Solid green Slowly dimming and brightening green Flashing yellow bars 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 this feature has been disabled. If your remote does not respond to a Inspire Sleep Remote English 13 200-423-001_Rev A_2580 Manual US.book Page 14 gentle shake, press the Therapy Off button (
therapy status.
) to display your 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 (
strength buttons allow you to change the stimulation strength.
) and decrease (
) stimulation 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 (
buttons do not change your stimulation strength.
) and Decrease (
) Upper limit light Stimulation strength gauge Figure 8. Stimulation strength gauge 14 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 15 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 this feature has been disabled. If your remote does not respond to a gentle shake, press the Therapy Off button (
to display your stimulation strength.
) Stimulation strength gauge: Means:
One bar lit Upper limit light on Solid white Solid green Slowly dimming and brightening green 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 15 200-423-001_Rev A_2580 Manual US.book Page 16 Status Lights Generator light Sleep remote battery light Figure 9. Status lights 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. 16 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 17 Status light:
Both status lights off Means:
Sleep remote and generator are operating normally Sleep remote battery light on Sleep remote batteries are low and need to be changed Generator light on Contact your doctor EMI light flashing Communication with your generator has been interrupted by electromagnetic interference
(EMI). Move away from potential sources of interference, and try again. Refer to Interference on page 9. Bluetooth light is on Sleep remote is in pairing mode. Inspire Sleep Remote English 17 200-423-001_Rev A_2580 Manual US.book Page 18 Bluetooth Pairing with a Mobile Phone Your sleep remote can connect to the Inspire Mobile App. See instructions below:
1. Download the Inspire Mobile App from your iOS or Android device and follow the mobile app instructions. 2. Remove the battery compartment cover. Go to Checking the Sleep Remote Battery Status on page 36 for more detailed information on removing the battery cover. 3. Push and hold the blue pairing button for 3 seconds until the Bluetooth light turns on. Note: The Bluetooth indicator will blink every second while the sleep remote is in pairing mode. 4. Wait for several seconds while the sleep remote securely pairs with the device. 5. When requested by the Inspire Mobile App, press the pairing button one time to confirm pairing. 6. The Bluetooth light will turn off when pairing is complete. 18 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 19 Bluetooth light Blue pairing button Figure 10. Bluetooth pairing with a mobile phone Audio Tones When audio tones are turned on, the sleep remote beeps when a change to the therapy settings is successfully completed. Note: You cannot adjust the volume of audio tones. Inspire Sleep Remote English 19 200-423-001_Rev A_2580 Manual US.book Page 20 Audio tone:
Means:
Your change was successful. Two beeps with the second beep at a higher tone than the first Three 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 21.) 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 29.) 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 30.) Communication with your generator was interrupted by electromagnetic interference. Move away from potential sources of interference, and try again. Six rapid beeps The sleep remote is updating the generator. Wait until you hear the success tone indicating the updating is complete. This update may take several seconds. Two beeps that repeat 20 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 21 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
) directly over your generator remote Therapy On button (
immediately after you press a button with the button facing away from you as shown below (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. Radio signals Generator Sleep remote Figure 11. Communication between sleep remote and generator Inspire Sleep Remote English 21 200-423-001_Rev A_2580 Manual US.book Page 22 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 the sleep remote produces 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 the sleep remote produces three rapid beeps, or the change you want is not indicated by the sleep remote lights, then try communicating with your generator again. 22 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 23 If you are having trouble positioning the sleep remote:
Note: These steps turn therapy off. 1. Press the Therapy Off button (
2. Position the sleep remote directly over your generator and against your body. The buttons should face away from your body (Figure 12).
). 3. Adjust the sleep remote position until the rear surface of the remote, opposite the Therapy On button (
over your generator (Figure 5).
), is directly 4. Wait until the sleep remote produces 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. Notes:
If the sleep remote produces 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. Inspire Sleep Remote English 23 200-423-001_Rev A_2580 Manual US.book Page 24 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 that the sleep remote is attempting to make a change to your generator. Status ring Figure 13. Status ring Status ring:
Means:
Whole ring blinking white Turning therapy off Whole ring blinking green Turning therapy on or pausing therapy Top of ring blinking Increasing stimulation strength Bottom of ring blinking Decreasing stimulation strength 24 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 25 Stimulation strength gauge Figure 14. Stimulation strength gauge Stimulation strength gauge:
Means:
Whole gauge blinking white Turning therapy off Whole gauge blinking green Turning therapy on or pausing therapy One step on the gauge is blinking Increasing or decreasing stimulation strength. The newly selected stimulation strength step is blinking. Inspire Sleep Remote English 25 200-423-001_Rev A_2580 Manual US.book Page 26 Turning Therapy On It is recommended that you turn therapy on as part of your bedtime routine. Immediately after turning therapy on, the generator will produce a brief stimulation pulse. 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 the sleep remote produces 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 26 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 27 stay on for several seconds after communicating with the generator. If the sleep remote lights are off, gently shake the remote and the lights turn on. Note: When you turn stimulation on, the generator will produce a brief stimulation pulse, 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 the sleep remote produces 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. Inspire Sleep Remote English 27 200-423-001_Rev A_2580 Manual US.book Page 28 Note: Pressing the Therapy Off button (
communication in progress. The sleep remote then attempts to turn your generator off.
) cancels 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 the sleep remote produces 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. 28 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 29 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 (
can be increased when therapy is on or off.
) the stimulation. Stimulation The stimulation strength gauge on the back of the sleep remote indicates the current stimulation strength and the upper limit
) indicates when you have reached the highest light (
stimulation strength allowed by your doctor. (For information on the stimulation strength gauge and upper limit, refer to page 14.) 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 (
positioning the sleep remote over your generator.
) and 2. Wait until the sleep remote produces a tone or 10 seconds 3. Turn therapy on by pressing the Therapy On button (
positioning the sleep remote over your generator.
) and 4. Wait until the sleep remote produces a tone or 10 seconds pass. pass. 5. You will receive one short stimulation immediately when therapy is turned on. Inspire Sleep Remote English 29 200-423-001_Rev A_2580 Manual US.book Page 30 To increase stimulation strength:
1. Press the Increase button (
). Note: If the sleep remote beeps rapidly three times, and the upper limit light (
have reached the upper limit.
) on the back of the remote is on, you 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 the sleep remote produces 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 (
Stimulation strength can be decreased with therapy on or off.
) the stimulation strength. 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 14.) Contact your doctor if you cant achieve the desired stimulation strength. 30 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 31 To test the current stimulation strength:
1. Turn therapy off by pressing the Therapy Off button (
positioning the sleep remote over your generator.
) and 2. Wait until the sleep remote produces a tone or 10 seconds 3. Turn therapy on by pressing the Therapy On button (
positioning the sleep remote over your generator.
) and 4. Wait until the sleep remote produces a tone or 10 seconds pass. 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 the sleep remote produces 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. Inspire Sleep Remote English 31 200-423-001_Rev A_2580 Manual US.book Page 32 32 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 33 5. Living with Your Inspire System 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 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. If you notice that your sleep remotes batteries deplete when you travel, you may want to remove the batteries during the transit portion of your trip(s). Once you arrive at your destination, install the batteries back into your sleep remote. When to Call Your Doctor Call your doctor if:
You experience anything unusual, such as new, unexplained symptoms. Inspire Sleep Remote English 33 200-423-001_Rev A_2580 Manual US.book Page 34 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. 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: 5500 Wayzata Blvd, Suite 1600 Golden Valley, MN 55416 Phone: 763-205-7970 or 1-844-672-4357 Toll Free Website: www.inspiresleep.com 34 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 35 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 AA or LR6 alkaline batteries. Replace the batteries when the sleep remote battery light is on or after 6 months of use. Cautions:
Do not use rechargeable batteries in the sleep remote. Rechargeable batteries may cause the sleep remote to not function properly. Inspire Sleep Remote English 35 200-423-001_Rev A_2580 Manual US.book Page 36 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 your sleep remote batteries. If the light is off and your sleep remote is responsive, your batteries are good. If no lights come on when you gently shake your sleep remote, replace the batteries. If your sleep remote is still unresponsive after replacing the batteries, contact your doctor. 36 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 37 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 37 200-423-001_Rev A_2580 Manual US.book Page 38 To replace the sleep remote batteries:
1. Insert your finger into the gap between a battery (+) terminal and the housing of the sleep remote. 2. Simultaneously, lightly press down and pull backwards on the battery so that the battery snaps out of place. 3. Remove the battery and repeat steps 1 and 2 to remove the second battery. 4. Position each new battery to match the figure of the battery compartment below (Figure 17). Note: Your sleep remote uses two AA batteries. Note: Do not use rechargeable batteries in your sleep remote. 5. Gently press down each battery to snap it into place. Figure 17. Battery compartment and battery placement 38 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 39 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. Inspect the battery door to make sure it is properly closed. 4. Inspire Sleep Remote English 39 200-423-001_Rev A_2580 Manual US.book Page 40 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:
Your sleep remote is water-resistant, not waterproof, and exposure to water or other liquids beyond a slightly damp cloth used for cleaning 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. 40 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 41 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 Sleep Remote Pick up or gently shake the sleep remote to display the status. If this feature is disabled, press the Therapy Off button and wait 10 seconds.. If the status ring is illuminated on the front of the remote, and
) on the back of the both the yellow status lights (
remote are off, you may resume use of your sleep remote. If both lights are not off, refer to page 17 of this manual to
) and (
determine the meaning of the status lights, and if both lights are lit you may need to replace your remote batteries (refer to page 37). If both the low battery (
) lights are on, the sleep remote may have an issue. Please contact your
) and interference (
Inspire Sleep Remote English 41 200-423-001_Rev A_2580 Manual US.book Page 42 doctor as your primary source for all questions and requests. As an additional resource, you may contact Inspire Medical Systems, Inc. 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 42 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 43 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 34. If this happens:
Possible causes:
Try these steps:
Yellow bars are flashing left and right on the front of your sleep remote. A status light on the back of the sleep remote is on. Turn the sleep remote over and view the status lights. For information on status lights, refer to page 16. For information on status lights, refer to page 16. A yellow light
) or or on the back of your sleep remote is on. No lights turn on after you press a button. Sunlight may obscure your view of the sleep remote lights. If you are outdoors, move indoors or use your sleep remote in the shade. Inspire Sleep Remote English 43 200-423-001_Rev A_2580 Manual US.book Page 44 If this happens:
Possible causes:
Try these steps:
No batteries, depleted batteries, or a battery is placed backwards in the battery compartment. The sleep remote may not be operating properly. Check the orientation of the batteries. If the batteries are oriented correctly, replace with new batteries (refer to page 35). If the problem persists, call your doctor. For information on status lights, refer to page 16. 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 (
battery is good (refer to page 40).
) is off, your generator The stimulation Confirm that the current strength is at the upper or lower limit. stimulation strength does not work for you. Contact your doctor to change the stimulation strength limits. Both status lights
) on the
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. You hear three beeps after pressing the Increase (
) or Decrease button
). 44 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 45 If this happens:
Possible causes:
Try these steps:
Review current therapy settings and try your change again. A setting in your generator has changed. Communication with your generator was not successful. You hear three beeps several seconds after pressing a button. Stimulation is uncomfortable. 1. Press the Therapy Off button
). 2. Reduce the stimulation strength by pressing the Decrease button
), and then holding the
sleep remote over your generator. 3. Press the Therapy On button
) to test the stimulation
strength. Decrease stimulation further if necessary (refer to page 29). Decrease stimulation (refer to page 29). page 28). Increase stimulation (refer to Inspire Sleep Remote English 45 Stimulation is too strong. Stimulation is not strong enough. 200-423-001_Rev A_2580 Manual US.book Page 46 If this happens:
Possible causes:
Try these steps:
You feel that a change took place after you pressed a button, but the sleep remote lights did not change. Hold the sleep remote closer to your generator. Review the positioning instructions on page 20. 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.) device interfered with communication between your sleep remote and generator. Therapy may not have turned on. Your stimulation may be delayed or paused. An electronic Turn off or move away from other electronic devices. Try your change again. You do not feel stimulation immediately when turning therapy on. 46 English Inspire Sleep Remote 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. 200-423-001_Rev A_2580 Manual US.book Page 47 If this happens:
Possible causes:
Try these steps:
The stimulation strength may be set too low. Your generator may need attention from your doctor. Your sleep remote lights do not turn on when it is gently shaken. This feature may have been disabled using a mobile phone. Your sleep remote falls into water. 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 28). If you still do not feel stimulation, contact your doctor. Pick up or gently shake the sleep remote. If the generator status light (
sleep remote is on, contact your doctor.
) on the back of the
) Press the Therapy Off button (
and wait 10 seconds. If the remote lights do not turn on, replace the remote batteries
(refer to page 35). 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. Insert new batteries. 5. Inspire Sleep Remote English 47 200-423-001_Rev A_2580 Manual US.book Page 48 If this happens:
Possible causes:
Try these steps:
Your sleep remote falls off a cabinet or table. Cannot pair with mobile phone Incorrect procedure used The sleep remote is designed to withstand a short drop and still operate normally, even if the case is chipped or otherwise damaged. Download the Inspire Mobile App, open the App, and follow the App instructions. Refer to Bluetooth Pairing with a Mobile Phone on page 18 for more information. Be sure to press the pairing button to confirm pairing as soon a prompted by the Inspire Mobile App. Enable the Bluetooth connection in your mobile phones settings. Process not completed within 60 seconds The mobile phones Bluetooth connection is disabled. 48 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 49 If this happens:
Possible causes:
Try these steps:
The Inspire Mobile App is not connecting to the sleep remote. The sleep remote can only be paired with one device at a time. Re-pair with the Inspire Mobile App. Refer to the steps in Bluetooth Pairing with a Mobile Phone on page 18. The mobile phones Bluetooth connection is disabled. Other Enable the Bluetooth connection in your mobile phones settings. 1. Reset the sleep remote pairing information by holding down the pairing button for 10 seconds. 2. Re-pair with the Inspire Mobile App. Refer to the steps in Bluetooth Pairing with a Mobile Phone on page 18 for more information. 3. Restart your mobile phone. Inspire Sleep Remote English 49 200-423-001_Rev A_2580 Manual US.book Page 50 50 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 51 8. Specifications If the sleep remote may have been stored at high or low temperatures or at greater than 90% humidity, store the sleep remote at room temperature and at less than 90% humidity for one hour before use. This will allow the remote to return to normal operating temperature. Inspire Sleep Remote Power source Operating temperature Storage temperature
(inside or outside of packaging) Operating humidity Storage humidity Operating/storage atmospheric pressure 2 AA or LR6 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) Protection against electric shock Internally powered equipment Battery life of sleep remote batteries 6 months (average) Expected service life of sleep remote 5-year expected (minimum) life Inspire Sleep Remote English 51 200-423-001_Rev A_2580 Manual US.book Page 52 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. Local laws take priority over the requirements of this section. Contact your doctor or Inspire for additional information. Do not modify the sleep remote. Changes or modifications could void the user's authority to operate the equipment. Do Not Modify FCC Statements This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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 used in accordance with the instructions, may cause harmful interference to radio 52 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 53 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 53 200-423-001_Rev A_2580 Manual US.book Page 54 54 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 55 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 55 200-423-001_Rev A_2580 Manual US.book Page 56 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. n 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. n 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. 6. The product must be returned to Inspire Medical Systems, 5500 Wayzata Blvd, Suite 1600, Golden Valley, MN 55416 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. 56 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 57 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 57 200-423-001_Rev A_2580 Manual US.book Page 58 58 English Inspire Sleep Remote 200-423-001_Rev A_2580 Manual US.book Page 1 200-423-001_Rev A_2580 Manual US.book Page 2 Manufacturer Inspire Medical Systems, Inc. 5500 Wayzata Blvd, Suite 1600 Golden Valley, MN 55416 USA Tel. 1-844-672-4357 Toll Free or 763-205-7970 Fax 763-537-4310 www.inspiresleep.com Inspire Medical Systems 2021 All Rights Reserved 200-423-001 Rev A
1 2 | Agent Authorization Letter | Cover Letter(s) | 833.67 KiB | July 13 2021 |
Inspire Sleep Apnea Innovation Agent Authorization Letter 10 June 2021 To whom it may concern, We, the undersigned, hereby authorize Joel Aaberg to act on our behalf, as our agent, in the following matters related to the FCC and/or Industry Canada approval of our products: report submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity Necessary to obtain such certification. Any act carried out by Joel Aaberg within the scope of this authorization shall have the same affect as our own. This authorization shall expire 12 months from original date. ee ha Dieken e |} ee (A ] Vn TES ia|
Program Director, Product Development Inspire Medical Systems, Inc. 5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416 844-OSA-HELP | InspireSleep.com
1 2 | Antenna Info | Operational Description | 2.25 MiB | July 13 2021 |
SPECIFICATION
Part No.
WLA.01
Model
2.4GHz High Efficiency Loop Antenna
Description
2.5dBi 2400MHz to 2500MHz
WLAN/WIFI/Bluetooth/Zigbee
Features
3.2*1.6*0.5mm
Low Profile
Peak gain 2.5dBi
50 Ohm Impedance
RoHS Compliant
SPE-11-8-146/M/SS Page 1 of 17
1. Introduction
The WLA.01 2.4GHz Loop antenna is a high efficiency, miniature SMD, edge mounted
ceramic antenna for very small space requirements for Wi-Fi, WLAN, Zigbee, Bluetooth,
and 802.11 applications. The WLA.01 uses the main PCB as its ground plane, thereby
increasing Antenna Efficiency. It is tuned for different PCB sizes by simply changing the
value of the matching circuit. At 3.2mm*1.6mm*0.5mm, the WLA.01 is one of the smallest
antennas available worldwide. This antenna is delivered on tape and Reel.
Many module manufacturers specify peak gain limits for any antennas that are to be
connected to that module. Those peak gain limits are based on free-space conditions. In
practice, the peak gain of an antenna tested in free-space can degrade by at least 1 or 2dBi
when put inside a device. So ideally you should go for a slightly higher peak gain antenna
than mentioned on the module specification to compensate for this effect, giving you better
performance.
Upon testing of any of our antennas with your device and a selection of appropriate layout,
integration technique, or cable, Taoglas can make sure any of our antennas’ peak gain will
be below the peak gain limits. Taoglas can then issue a specification and/or report for the
selected antenna in your device that will clearly show it complying with the peak gain
limits, so you can be assured you are meeting regulatory requirements for that module.
For example, a module manufacturer may state that the antenna must have less than
2dBi peak gain, but you don’t need to select an embedded antenna that has a peak gain
of less than 2dBi in free-space. This will give you a less optimized solution. It is better to
go for a slightly higher free-space peak gain of 3dBi or more if available. Once that antenna
gets integrated into your device, performance will degrade below this 2dBi peak gain due
to the effects of GND plane, surrounding components, and device housing. If you want to
be absolutely sure, contact Taoglas and we will test. Choosing a Taoglas antenna with a
higher peak gain than what is specified by the module manufacturer and enlisting our help
will ensure you are getting the best performance possible without exceeding the peak
gain limits.
1.1 Applications
• Bluetooth earphone systems
•
IEEE802.11 b/g
• ZigBee
• Wireless PCMCIA cards or USB dongle
• Hand-held devices when Bluetooth/Wi-Fi functions are needed, e.g., Smart phone.
SPE-11-8-146/M/SS Page 2 of 17
2. Specifications
The WLA.01 is designed to mount at the center of the edge of an evaluation board of
80 x 40mm.The antenna performance was measured with the WLA.01 mounted on the
evaluation board with SMA(F) connector.
No
Parameter
Center Frequency
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Dimensions
VSWR
Polarization
Bandwidth
Gain
Efficiency
Impedance
Dimensions
Material
Mechanical
Environmental
Specification*
2400-2500MHz
3.2*1.6*0.5mm
2 max
Linear
100MHz min.
Peak 2.5dBi typ.
84% typ.
50 W
3.2*1.6*0.5mm
Ceramic
-40°C~+85°C
-40°C~+105°C
Operating Temperature
Storage Temperature
Temperature Coefficient(τf)
0 ± 20 ppm @-20ºC to +80ºC
Recommended Reel Storage
5°C to 40°C
Condition
Relative Humidity 20% to 70%
* The data was measured by a CTIA Authorized Test Lab.
** Center frequency will be offset to working frequency according to the conditions of user’s
Ground plane and radome.
SPE-11-8-146/M/SS Page 3 of 17
3. Electrical Specification (80*40mm ground plane)
3.1 Return Loss(S11)
SPE-11-8-146/M/SS Page 4 of 17
3.2 VSWR
SPE-11-8-146/M/SS Page 5 of 17
4. Radiation Pattern (Customize Design)
4.1 Radiation Pattern (80mmX40mm ground plane)
Z
X
Y
SPE-11-8-146/M/SS Page 6 of 17
4.2 3D Gain pattern @2442MHz
SPE-11-8-146/M/SS Page 7 of 17
4.3 Efficiency Table
SPE-11-8-146/M/SS Page 8 of 17
4.4 Efficiency vs Frequency
SPE-11-8-146/M/SS Page 9 of 17
5. Layout Guide
5.1 Solder Land Pattern
Land pattern for soldering (grey marking areas) is as shown below. A matching circuit
similar to the one shown in section 5.3 is also required.
SPE-11-8-146/M/SS Page 10 of 17
5.2 Solder Land Pattern
This antenna includes a fine tuning element (as shown in the land patterns above)
that can be used to slightly shift antenna resonance.
5.3 Matching Circuit
Like all antennas, surrounding components, enclosures, and changes to the GND plane
dimensions can alter performance. A pi-matching network like the one shown below is
required in case adjustments need to be made. The antenna EVB has a similar matching
network. The components on the EVB are a good starting point for a new design, but will
need to be adjusted upon integration for best performance. The zero ohm resistor is
needed for the ability to solder down a coax pigtail to make measurements with a vector
network analyzer.
SPE-11-8-146/M/SS Page 11 of 17
6. Antenna Drawings
6.1 Antenna Main Body
6.2 Antenna with EVB
SPE-11-8-146/M/SS Page 12 of 17
6.3 Footprint on EVB
SPE-11-8-146/M/SS Page 13 of 17
47mm
7. Packaging
6000pcs WLA.01 per Tape and Reel
Dimensions: Ø330*60mm
Weight: 3.23Kg
6000pcs WLA.01 per Carton
Dimensions: 340*340*90mm
Weight:3.5Kg
60mm
m
m
0
3
3
Ø
m
m
0
9
340mm
340mm
SPE-11-8-146/M/SS Page 14 of 17
7.1 Tape Dimensions (unit: mm)
Feature
Specifications
Tolerances
W
P
E
F
P2
D
Po
10Po
Ao
Bo
Ko
t
12
8
1.75
5.5
2
1.5
4
40
1.9
3.5
0.8
0.3
7.2 Pocket Dimensions (unit: mm)
Feature
Specifications
Tolerances
±0.30
±0.10
±0.10
±0.10
±0.10
±0.10
±0.10
±0.20
±0.10
±0.10
±0.10
±0.05
SPE-11-8-146/M/SS Page 15 of 17
8. Recommended Reflow Temp Profile
The WLA.01 Loop Antenna can be assembled following either Sn-Pb or Pb-Free assembly
processes. The recommended soldering temperatures are as follows:
SPE-11-8-146/M/SS Page 16 of 17
Taoglas makes no warranties based on the accuracy or completeness of the contents of this document
and reserves the right to make changes to specifications and product descriptions at any time without
notice. Taoglas reserves all rights to this document and the information contained herein.
Reproduction, use or disclosure to third parties without express permission is strictly prohibited.
Copyright © Taoglas
SPE-11-8-146/M/SS Page 17 of 17
1 2 | Cover Letter | Cover Letter(s) | 38.43 KiB | July 13 2021 |
10 June 2021
Federal Communications Commission
Authorization and Evaluation Division
7435 Oakland Mills Road
Columbia, Maryland 21046
Re: FCC Application
FCC ID: 2AGO22580
To whom it may concern,
We, Inspire Medical Systems Inc., hereby apply for original certification of the radios included in the
Model 2580 Patient Remote. The telemetry intentional radiator operates at 175kHz and is compliant to 47
CFR §15.209. The Bluetooth radio operates at 2.4GHz and is compliant to 47 CFR §15.247.
Sincerely,
Sr. Director Regulatory: Joel Aaberg
Telephone Number:
Email:
763-205-7972
joelaaberg@inspiresleep.com
Inspire Medical Systems, Inc.
5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416
844-OSA-HELP | InspireSleep.com
1 2 | Request for Confidentiality | Cover Letter(s) | 168.16 KiB | July 13 2021 |
10 June 2021
Federal Communications Commission
Authorization and Evaluation Division
7435 Oakland Mills Road
Columbia, Maryland 21046
Re: Request for confidentiality
FCC ID: 2AGO22580
To whom it may concern,
Pursuant to Sections 0.457(d) and 0.459 of the Commission’s Rules, Inspire Medical Systems, Inc.
hereby requests long-term confidential treatment of information accompanying this application as outlined
below:
Inspire Medical Systems, Inc. also hereby requests short-term confidential treatment of information
accompanying this application as outlined below for a period of 180 days:
• Block Diagram
• Operational Description
• Schematics
• User Manual
• External Photos
• Test Set-up Photographs
•
Internal Photos
The above materials contain trade secrets and proprietary information not customarily released to the
public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified
benefits to its competitors.
The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all
accompanying materials will not be made before the date of the Grant for this Application.
Yours sincerely,
Name: Joel Aaberg
Title: Senior Director of Regulatory Affairs
Inspire Medical Systems, Inc.
5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416
844-OSA-HELP | InspireSleep.com
1 2 | Test Setup Photos | Test Setup Photos | 857.42 KiB | July 13 2021 / January 09 2022 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-07-13 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
2 | 0.175 ~ 0.175 | DCD - Part 15 Low Power Transmitter Below 1705 kHz |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2021-07-13
|
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1 2 | Applicant's complete, legal business name |
Inspire Medical Systems, Inc.
|
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1 2 | FCC Registration Number (FRN) |
0025086356
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1 2 | Physical Address |
5500 Wayzata Blvd
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1 2 |
Golden Valley, Minnesota 55416
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1 2 |
United States
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
a******@element.com
|
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1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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1 2 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
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app s | FCC ID | |||||
1 2 | Grantee Code |
2AGO2
|
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1 2 | Equipment Product Code |
2580
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
D**** D******
|
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1 2 | Title |
Program Director
|
||||
1 2 | Telephone Number |
763-2********
|
||||
1 2 | Fax Number |
763-5********
|
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1 2 |
d******@inspiresleep.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | 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 2 | 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 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/09/2022 | ||||
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 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 2580 | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | 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 2 | Grant Comments | Output power listed is conducted. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | 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 2 | Firm Name |
Element Materials Technology Minneapolis
|
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1 2 | Name |
R****** W********
|
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1 2 | Telephone Number |
503-8******** Extension:
|
||||
1 2 | Fax Number |
503-8********
|
||||
1 2 |
r******@element.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0030000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 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