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

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

Contents

User Manual Part 2

22 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Audio Tones When audio tones are turned on, the sleep remote beeps when a change to the therapy settings is successfully completed.Audio tone: Means:Two beeps with a rising tone• Your change was successful.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 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.)Six rapid beeps• Communication with your generator was interrupted by electromagnetic interference. Move away from potential sources of interference, and try again.
Inspire Sleep Remote English 23200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Turning 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).Figure 10. Turning audio tones on or off3. Replace the battery compartment cover. (For instructions, refer to page 42.)OffOnAudio tonesswitchDo not connect anything to this port
24 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Using Your Inspire Sleep RemotePositioning Your Sleep RemoteThe 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. Figure 11. Communication between sleep remote and generatorSleep remoteGeneratorRadio signals
Inspire Sleep Remote English 25200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002To 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 generator3. 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.
26 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002If 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.
Inspire Sleep Remote English 27200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Communicating 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. Figure 13. Status ring Status ring: Means:Whole ring blinking white Turning therapy offWhole ring blinking green Turning therapy on or pausing therapyTop of ring blinking Increasing stimulation strengthBottom of ring blinking Decreasing stimulation strengthStatusring
28 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Figure 14. Stimulation strength gaugeStimulation strength gauge:Means:Whole gauge blinking whiteTurning therapy offWhole gauge blinking greenTurning therapy on or pausing therapyOne step on the gauge is blinkingIncreasing or decreasing stimulation strength. The newly selected stimulation strength step is blinking.Stimulation strength gauge
Inspire Sleep Remote English 29200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Turning Therapy OnIt 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 generator3. 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.
30 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 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 OffAlways 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 ( ) cancels communication in progress. The sleep remote then attempts to turn your generator off.
Inspire Sleep Remote English 31200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Pausing TherapyIf 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.
32 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Increasing Stimulation StrengthThe 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 ( ) indicates when you have reached the 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 can’t achieve the desired stimulation strength.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.
Inspire Sleep Remote English 33200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002To 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 StrengthThe 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 can’t achieve the desired stimulation strength.
34 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch4.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002To 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.
Inspire Sleep Remote English 35200-161-101 Rev A3032PatEN_ch5.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0025. Living with Your Inspire SystemActivities and ExerciseOn 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 InformationAs 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
36 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch5.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002generator. 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 DoctorCall 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.
Inspire Sleep Remote English 37200-161-101 Rev A3032PatEN_ch5.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Manufacturer's InformationYour 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 55369Phone: 763-205-7970 or 1-844-672-4357 Toll FreeWebsite: www.inspiresleep.com
38 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch5.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
Inspire Sleep Remote English 39200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0026. Maintaining Your Inspire Sleep RemoteYou 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 BatteriesWarning: 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.
40 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Cautions:•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 StatusDevelop 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.
Inspire Sleep Remote English 41200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Replacing the Sleep Remote BatteriesThe 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 cover2. Push gently and firmly upward on the release tab at the end of the sleep remote.3. Gently rotate the cover upwards.
42 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002To 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).Figure 17. BatterycompartmentandbatteryplacementTo 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. Finger holeDo not connect anything to this port
Inspire Sleep Remote English 43200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Battery and Sleep Remote DisposalDispose 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 RemoteClean 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.
44 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch6.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Handling Your Sleep RemoteThe 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 StatusYou 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 ( ) on the back of your sleep remote. If the light is on, contact your doctor.
Inspire Sleep Remote English 45200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0027. Troubleshooting Your Sleep RemoteThe 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:Try these steps:Yellow bars are flashing left and right on the front of your sleep remote.• A status light on 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 20. A yellow light (or ) on the back of your sleep remote is on.• For information on status lights, refer to page 20.
46 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002No 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.• No batteries, depleted batteries, or a battery is placed backwards in the battery compartment.• 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.Both status lights () on the back of the sleep remote are on, and the sleep remote does not work.• 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. You want to check your generator battery without making any other changes.• Pick up or gently shake the sleep remote to display the battery status. If the generator status light ( ) is off, your generator battery is good (refer to page 44).If this happens: Possible causes:Try these steps:
Inspire Sleep Remote English 47200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002You do not hear audio tones, but the sleep remote is working.• Audio tones are turned off.• Turn audio tones on (refer to page 23).You hear three beeps after pressing the Increase ( ) or Decrease button ().• 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.You hear three beeps several seconds after pressing a button.• A setting in your generator has changed.• Communication with your generator was not successful.• Review current therapy settings and try your change again.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 33).If this happens: Possible causes:Try these steps:
48 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Stimulation is too strong.• Decrease stimulation (refer to page 33).Stimulation is not strong enough.• Increase stimulation (refer to page 32).You feel that a change took place after you pressed a button, but the sleep remote lights did not change.• 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.)• Hold the sleep remote closer to your generator. Review the positioning instructions on page 24. Try your change again.• An electronic device interfered with communication between your sleep remote and generator.• Turn off or move away from other electronic devices. Try your change again.If this happens: Possible causes:Try these steps:
Inspire Sleep Remote English 49200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002You do not feel stimulation immediately when turning therapy on.• Therapy may not have turned on.• 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.• Your stimulation may be delayed or paused.• 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.• The stimulation strength may be set too low.• 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.• Your generator may need attention from 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.If this happens: Possible causes:Try these steps:
50 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch7.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Your sleep remote lights do not turn on when it is gently shaken.Your sleep remote may have been excessively bounced during the previous 30 minutes and has temporarily disabled motion sensing to save battery life.• 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).Your sleep remote falls into water.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.Your sleep remote falls off a cabinet or table.• The sleep remote is designed to withstand a short drop and still operate normally, even if the case is chipped or otherwise damaged.If this happens: Possible causes:Try these steps:
Inspire Sleep Remote English 51200-161-101 Rev A3032PatEN_ch8.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0028. SpecificationsIf 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 RemotePower source 2 AAA or LR03 alkaline batteriesOperating temperature 5 – 40°C41 – 104°FStorage temperature (inside or outside of packaging)-25 – 70°C-13 – 158°FOperating humidity 15 – 90%Storage humidity up to 90%Operating/storage atmospheric pressure700 hPa – 1060 hPa (20.7 Hg – 31.3 Hg)Protection against electric shock Internally powered equipmentBattery life of sleep remote batteries2 months (average)Expected service life of sleep remote5-year expected (minimum) life
52 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch8.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Connections to Additional EquipmentAnybody 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 StatementsThis 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
Inspire Sleep Remote English 53200-161-101 Rev A3032PatEN_ch8.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002used 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.
54 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_ch8.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
Inspire Sleep Remote English 55200-161-101 Rev A3032PatEN_Warranty.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002Inspire Medical Systems Limited WarrantySummaryInspire 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.
56 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_Warranty.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002During 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 Conditions1. 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.
Inspire Sleep Remote English 57200-161-101 Rev A3032PatEN_Warranty.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 0026. 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 PeriodThe 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.
58 English Inspire Sleep Remote200-161-101 Rev A3032PatEN_Warranty.fm 10/30/15 8:55 am4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
200-161-101 Rev A3032PatEN_MLbcv.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002
© Inspire Medical Systems 2015All Rights Reserved200-161-101 Rev A3032PatEN_MLbcv.fm 10/30/15 8:55 am 4.625 x 6 inches (117 mm x 152 mm) Inspire Medical ConfidentialInspire 002200-161-101 Rev AManufacturerInspire Medical Systems, Inc.9700 63rd Avenue NorthMaple Grove, MN 55369USATel. 1-844-672-4357 Toll Freeor 763-205-7970Fax 763-537-4310www.inspiresleep.comHealthLink Europe Services BVDe Tweeling 20-225215 MC ‘s-HertogenboschThe NetherlandsTel. +31.13.5479300Attn: Quality Department

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