Inspire SLEEP REMOTE Manual Download Page 72

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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

MedPass SAS
95bis Boulevard Pereire
75017 Paris – France
+33 (0)1 42 12 28 84

Summary of Contents for SLEEP REMOTE

Page 1: ...INSPIRE SLEEP REMOTETM Rx Only Inspire Sleep Remote Model 2500 ...

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 RemoteTM ...

Page 3: ...py Turn therapy off Decrease stimulation strength Increase stimulation strength Replace sleep remote batteries If the light is on but not flashing your generator battery may be low If the light is on and flashing communication with your generator has been interrupted Audio tones on Audio tones off Package Symbols Consult instructions for use For USA audiences only ...

Page 4: ...bol means that the device fully complies with applicable European Directives European authorized representative IEC 60529 Protection from ingress by fingers or similar objects and moderate amounts of dripping water Note The sleep remote meets the water ingress rating of IP22 maintaining safe operation Exposure to water or liquids could result in a loss of performance Keep the sleep remote dry Refe...

Page 5: ...or 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 Status Ring White Therapy is off Green Solid Therapy is on and stimulation is on Green Dimming and brightening Therapy is on stimulation is paused Therapy On Therapy Off Increase stimulation strength Decrease stimulation strength Status ring Pause ...

Page 6: ...roduces three beeps immediately when you press the Decrease button stimulation strength is at the lower limit Increasing Stimulation Strength Press the Increase button and hold the sleep remote over your generator for 10 seconds or until the sleep remote produces an audio tone If the sleep remote produces three beeps immediately when you press the Increase button stimulation strength is at the upp...

Page 7: ...t flashing your generator battery may be low call your doctor If the light is on and flashing communication with your generator has been interrupted Refer to Interference on page 9 Stimulation strength is at the upper limit Stimulation strength gauge Sleep remote battery light Generator light Upper limit light Stimulation strength gauge ...

Page 8: ... 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 Audio Tones Two beeps with the second beep at a higher tone than the first Communication with the generator was successful Three rapid beeps Communication with the generator was not successful try again Stimulation is at the upper or lower li...

Page 9: ...ts 2 2 Inspire Therapy 3 Your Inspire System 3 Therapy Summary 4 Additional Therapy Information 5 Frequently Asked Therapy Questions 5 3 Safety Information 7 Warnings 7 Precautions 8 System and Therapy 8 Patient Activities 9 Interference 9 4 Using Your Sleep Remote 11 Sleep Remote Buttons 12 Status Ring 13 Stimulation Strength Gauge 14 Status Lights 16 Audio Tones 18 Turning Audio Tones On or Off ...

Page 10: ...ormation 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 39 Cleaning Your Sleep Remote 39 Handling Your Sleep Remote 40 Checking the Sleep Remote 40 Checking the Generator Battery Status 41 7 Troubles...

Page 11: ...Inspire Sleep Remote English ix Inspire Medical Systems Limited Warranty 53 ...

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Page 13: ...ctronics that control stimulation Hypoglossal Nerve The nerve that controls tongue movement Implantable Pulse Generator IPG See Generator Your doctor may refer to your generator as an IPG or implantable pulse generator Lead A thin implanted wire with protective coating that connects to the generator The Inspire system has a respiratory sensing lead and a stimulation lead Pause A delay in therapy t...

Page 14: ...n 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 th...

Page 15: ...deliver Inspire Upper Airway Stimulation UAS therapy Figure 3a Your doctor has given you an Inspire Sleep RemoteTM Figure 3b Use your sleep remote to turn your therapy on and off and adjust the strength of stimulation Figure 3 Inspire system a b Implanted components Inspire Sleep Remote ...

Page 16: ...planted 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 Ins...

Page 17: ...Upper Airway Stimulation UAS therapy Your doctor prescribed UAS therapy to treat your sleep apnea For more information about your Inspire system refer to your Inspire Patient Manual Your Inspire System Figure 4 Implanted components of the Inspire system Stimulation lead Respiratory sensing lead Generator ...

Page 18: ... 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 system Physician programmer That your doctor uses to program 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 ar...

Page 19: ...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 unc...

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Page 21: ...ction 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 in...

Page 22: ...me 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 connection to other equipment Do not connect the sleep remote to other equipment cables or ...

Page 23: ...te that mobile phones may interfere with sleep remote communications if operated at the same time and within 70 cm 2 3 ft A flashing as shown on page 17 indicates there is interference with the communication between your remote and your generator If you suspect that equipment is causing unwanted stimulation or interfering with your Inspire system do the following 1 Move away from the equipment or ...

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Page 25: ... 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 directly over your generator and facing away from you as shown below Figure 5 Figure...

Page 26: ...nd to pause therapy Also you can increase or decrease your stimulation strength within a range selected by your doctor Select To Turn therapy on If therapy is on pause therapy Turn therapy off Decrease the stimulation strength Increase the stimulation strength Therapy On Therapy Off Increase stimulation strength Decrease stimulation strength Status ring Pause ...

Page 27: ...our therapy status Note Your sleep remote may not respond to a gentle shake if it has been excessively bounced during the previous 30 minutes such as when it has been in a car If your remote Status ring light Means Solid white Therapy is off Solid green Therapy is on and stimulation is active Slowly dimming and brightening green Therapy is on and stimulation is paused Flashing yellow bars A yellow...

Page 28: ...w you to change the stimulation strength The stimulation strength gauge on the back of the sleep remote indicates the current stimulation strength and if the stimulation strength has reached the upper or lower limit Figure 8 The stimulation strength gauge color also indicates if therapy is on off or paused Note If your doctor did not program a range of stimulation strengths for you to use the Incr...

Page 29: ...ous 30 minutes such as when it has been in a car If your remote does not respond to a gentle shake press the Therapy Off button and wait for 10 seconds Stimulation strength gauge Means One bar lit Stimulation strength is at minimum and may not be decreased Upper limit light on Stimulation strength is at maximum and may not be increased Solid white Therapy is off Solid green Therapy is on and stimu...

Page 30: ...te indicate the status of your generator and sleep remote batteries Figure 9 Note When either status light turns on yellow bars on the status ring flash The status ring is on the front of the sleep remote The bars flash for several seconds to notify you to check the status lights on the back of the sleep remote Sleep remote battery light Generator light ...

Page 31: ...act your doctor Both status lights on Replace sleep remote batteries because low batteries may be preventing normal sleep remote operation If condition persists contact your doctor Your sleep remote may not be working properly Generator light flashing Communication with your generator has been interrupted by electromagnetic interference Move away from potential sources of interference and try agai...

Page 32: ... instructions on positioning your sleep remote refer to page 20 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 28 You tried to decrease the stimulation strength outside the range set by your doctor and you have reached the lower limit For instructions on ...

Page 33: ...dio tones on or off 1 Remove the battery compartment cover For instructions refer to page 37 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 off 3 Replace the battery compartment cover For instructions refer to page 38 Off On Audio tones switch Do not connect anything to this port ...

Page 34: ...utton directly over your generator 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 Figure 11 Communicat...

Page 35: ...oning 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 produ...

Page 36: ...te opposite the Therapy On button is directly over your generator Figure 5 5 Wait until the sleep remote produces 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 the sleep remote produces three rapid beeps or the change you want is not indicated by the sleep remote lights th...

Page 37: ...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 off Whole ring blinking green Turning therapy on or pausing therapy Top of ring blinking Increasing stimulation strength Bottom of ring blinking De...

Page 38: ...h 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 Stimulation strength gauge ...

Page 39: ...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 ...

Page 40: ...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 pas...

Page 41: ...omatically 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...

Page 42: ...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 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 the sleep remote produces a tone or 10...

Page 43: ...strength a Turn therapy off b Turn therapy on You will receive one short stimulation immediately when therapy is turned on Decreasing Stimulation Strength The sleep remote allows you to decrease the stimulation strength within a range set by your doctor If stimulation feels too strong you may want to decrease the stimulation strength Stimulation strength can be decreased with therapy on or off The...

Page 44: ... until the sleep remote produces 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 rem...

Page 45: ...Inspire Sleep Remote English 31 b Turn therapy on You will receive one short stimulation immediately when therapy is turned on ...

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Page 47: ... 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 When to Call Your Doctor Call your doctor if You experience anything unusual such as new unexplained symptoms You notice signs o...

Page 48: ...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 Blv...

Page 49: ... sleep remote to check your generator battery status Sleep Remote Batteries Warning The sleep remote batteries may pose a choking hazard Keep the sleep remote and batteries away from children and pets The sleep remote uses two AAA or LR03 alkaline batteries Replace the batteries when the sleep remote battery light is on or after 4 months of use Cautions Do not use rechargeable batteries in the sle...

Page 50: ...Status Develop a routine where you check your sleep remote battery status regularly Inspire recommends checking the sleep remote batteries each morning after you turn therapy off To check the sleep remote battery status 1 Pick up or gently shake the sleep remote 2 Check the sleep remote battery light on the back of your sleep remote If the light is on replace the sleep remote batteries If the ligh...

Page 51: ...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 ...

Page 52: ...ttery compartment Figure 17 Figure 17 Battery compartment and battery placement To close the battery compartment 1 Insert the battery door tabs into the two slots located above the batteries 2 Gently lower the battery compartment cover 3 Gently press down on the end of the battery compartment cover to lock it in place 4 Inspect the battery door to make sure it is properly closed Finger hole Do not...

Page 53: ...mote 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...

Page 54: ... 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 the status ring is illuminated on the front of the remote and both the yellow status lights and on the back of the remote are off you may resume use of your sleep remote If both lights are not of...

Page 55: ... 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 ...

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Page 57: ...e 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 ...

Page 58: ...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 16 If all the lights stay on call your d...

Page 59: ...mulation 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 ove...

Page 60: ...e 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 20 Try your change again An electronic device interfered with communication between your sleep remote and generator Turn off or move away from other ...

Page 61: ...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 28 If you still do not feel stimulation contact your doctor Yo...

Page 62: ... batteries refer to page 35 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...

Page 63: ...ting temperature Inspire Sleep Remote Power source 2 AAA or LR03 alkaline batteries Operating temperature 5 40 C 41 104 F Storage temperature inside or outside of packaging 25 70 C 13 158 F Operating humidity 15 90 Storage humidity up to 90 Operating storage atmospheric pressure 700 hPa 1060 hPa 20 7 Hg 31 3 Hg Protection against electric shock Internally powered equipment Battery life of sleep re...

Page 64: ...s must comply with the requirements for medical electrical systems see IEC 60601 1 1 or clause 16 of the 3Ed of IEC 60601 1 respectively Local laws take priority over the requirements of this section Contact your doctor or Inspire for additional information Do Not Modify Do not modify the sleep remote Changes or modifications could void the user s authority to operate the equipment FCC Statements ...

Page 65: ...erference 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 receivi...

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Page 67: ...itness 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...

Page 68: ...p 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 Sys...

Page 69: ...ANTABILITY 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 h...

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Page 72: ...1 Rev E 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 MedPass SAS 95bis Boulevard Pereire 75017 Paris France 33 0 1 42 12 28 84 ...

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