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5

WARNINGS 

(Preventing electrical shock):

  •   

DO NOT

 attempt to open the console for any reason. The console does not contain any parts that 

you can service. If you have a problem with console operation, contact Winx Customer Service at 
888-986-6275 or 650-361-9300.

  •   

DO NOT

 immerse the console in water or any other liquid.

  •   

DO NOT

 operate the unit on wet surfaces.

  •  

 NEVER

 allow fluids to get inside the console. If you think water or other fluids may have penetrated 

the inside of the console, 

DO NOT

 use the system. Unplug the console from the wall outlet and 

contact Winx Customer Service at 888-986-6275 or 650-361-9300.

  •  

 DO  NOT

 use the device in the presence of a flammable mixture or flammable anesthetic.

  •  

 

Only use the electrical power cord included with your system kit.

General Warnings and Precautions

PN 12149-B.indd   5

4/23/13   11:53 AM

Summary of Contents for Winx

Page 1: ...Winx Sleep Therapy System User Guide for Patients PN 12149 B indd 1 4 23 13 11 53 AM...

Page 2: ...PN 12149 B indd 2 4 23 13 11 53 AM...

Page 3: ...This User Guide contains instructions for using the Winx Sleep Therapy System Read all Instructions for Use before using the system Sleep Therapy System User Guide PN 12149 B indd 3 4 23 13 11 53 AM...

Page 4: ...PN 12149 B indd 4 4 23 13 11 53 AM...

Page 5: ...ng the system 14 Preparing your system for next use 15 Care and maintenance of your Winx Sleep Therapy System 17 Cleaning your mouthpiece 17 Cleaning the reservoir 18 Cleaning your console 19 Flushing...

Page 6: ...PN 12149 B indd 6 4 23 13 11 53 AM...

Page 7: ...maintain an open airway A reservoir is built into the console to collect any saliva that may be drawn through the mouthpiece and tubing A user should be able to breathe through his her nose without mo...

Page 8: ...ly power cord that you can use with your Winx Sleep Therapy System Front View Back View Data Card USB Port Cover Power Cord Jack Reservoir Ejection Button Reservoir After Ejection ON OFF Button Reserv...

Page 9: ...R TUBING Check that all items are included in your packaging Contact Winx Customer Service at 888 986 6275 or 650 361 9300 if any items are missing Winx Sleep Therapy System Components Arched Pad Lip...

Page 10: ...uum break Not lit Periodic flash Winx Sleep Therapy System Console Icons and States Empty partially full Clean soon Clean now Not lit OFF Warming up Ready Needs attention Not lit Power icon Reservoir...

Page 11: ...DO NOT operate the unit on wet surfaces NEVER allow fluids to get inside the console If you think water or other fluids may have penetrated the inside of the console DO NOT use the system Unplug the c...

Page 12: ...ull Excessive salivation Obstruction of oral breathing If the mouthpiece causes prolonged discomfort remove it and contact your physician The mouthpiece and tubing are for your use only DO NOT share y...

Page 13: ...t of mouthpiece fit should be ascertained including maintenance of oral vacuum during device use Device effectiveness has not been assessed in patients with nighttime mouth breathing CAUTION Preventin...

Page 14: ...8 PN 12149 B indd 8 4 23 13 11 53 AM...

Page 15: ...t sheet towel etc b Connect the power cord into the back of console and plug the other end of the cord into a standard wall outlet 100 240 V AC Position the power cord to avoid creating a tripping haz...

Page 16: ...n Make sure the tubing will not get tangled or kinked while you sleep Leave some slack in the tubing for when you might turn over or move around d Fully insert the tubing into the console as shown Mou...

Page 17: ...saliva that may occur when using the system Check the reservoir icon on the top of the console to determine the fill level of the reservoir The icon will indicate the fill level If the icon is Not li...

Page 18: ...he mouthpiece in one hand as shown The mouthpiece should be held with the arched pad toward the back of your mouth and the lip seal to the front Make sure the arched pad is facing up toward the roof o...

Page 19: ...ve difficulty maintaining target vacuum during use refer to the troubleshooting guide under cannot feel vacuum in mouth for potential solutions If this problem persists contact Winx Customer Service a...

Page 20: ...period of time disconnect the mouthpiece from the tubing and leave the mouthpiece in your mouth Keep the console power turned ON if the plan is to return to bed in a few minutes If the mouthpiece nee...

Page 21: ...m for next use Rinse and clean the mouthpiece and reservoir after each use Flush and clean the entire system weekly See next section Care and maintenance of your Winx Sleep Therapy System PN 12149 B i...

Page 22: ...16 PN 12149 B indd 16 4 23 13 11 53 AM...

Page 23: ...wel Store your mouthpiece in the mouthpiece holder away from direct heat or sunlight and away from pets Note DO NOT clean the mouthpiece tubing and reservoir with strong cleaning agents such as deterg...

Page 24: ...inside of the reservoir lid Shake lid gently to remove excess water Allow lid to air dry for at least five minutes before replacing the insert and lid Replace the lid by turning it clockwise If water...

Page 25: ...ons to clean the console Once a week you should flush the entire system Flushing the entire system 1 Connect the mouthpiece to tubing and place the tubing on a flat surface 2 Place the mouthpiece hold...

Page 26: ...er about 30 seconds there should be very little to no water left in the holder Continue to run the console for another 15 seconds to remove any remaining water in the tubing 6 Turn the console OFF Not...

Page 27: ...r or if you intend to travel with the system When traveling internationally be familiar with electrical requirements within those regions The Winx Sleep Therapy System is compatible with electrical ou...

Page 28: ...th your finger and then release The card will be ejected 3 Grasp the end of the card and remove it from the console 4 Insert a new data card by pushing the card into the console data card slot until i...

Page 29: ...23 Disposal Dispose of the Winx Sleep Therapy System according to local regulations for disposal of electronic devices PN 12149 B indd 23 4 23 13 11 53 AM...

Page 30: ...24 PN 12149 B indd 24 4 23 13 11 53 AM...

Page 31: ...e the tubing connects to the console and mouthpiece Make sure all connections are properly seated Check tubing for cracks leaks If you find a crack or leak you may need to replace the tubing Contact W...

Page 32: ...ically If the power icon is flashing yellow unplug the console Plug it back in and press the power button If the yellow icon continues to flash contact Winx Customer Service at 888 986 6275 or 650 361...

Page 33: ...and the pad should rest in the back of your mouth Make sure mouthpiece is attached to the tubing Console tubing leak Make sure all connections are properly seated Make sure the lid on the reservoir i...

Page 34: ...n mouth Cannot maintain target vacuum continued System blocked continued Follow cleaning instructions for flushing the entire system with water If flushing the entire system with water does not solve...

Page 35: ...to your teeth or gums DO NOT use the mouthpiece Contact your physician Problem Possible Cause Solution Console display flashing yellow icon System reboot required If the power icon is flashing yellow...

Page 36: ...30 PN 12149 B indd 30 4 23 13 11 53 AM...

Page 37: ...1 4 lbs 0 65 kg Vacuum Setting 20 inH2 0 51 cmH2 0 Vacuum Accuracy 10 Operating Temperature Humidity 5 to 40 C and 15 to 95 humidity noncondensing Storage Temperature Humidity 20 to 60 C and 15 to 95...

Page 38: ...rmonic Emissions EN 61000 3 2 Class A Voltage fluctuations flicker emissions EN 61000 3 3 Complies Warning The use of accessories transducers and cables other than those specified with the exception o...

Page 39: ...ical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycle...

Page 40: ...y occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic...

Page 41: ...power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 7...

Page 42: ...current USB Universal Serial Bus SD card Temperature limitation Manufacturer Serial number Catalog number Data ports for physician use only Lot number Batch code CAUTION Federal Law restricts this dev...

Page 43: ...bove warranty as customer s sole remedy and ApniCure s sole liability ApniCure will repair or replace at its discretion any nonconforming material or part Warranty claims on defective Product must be...

Page 44: ...e Mouthpiece or Tubing Warranty is void on product which is sold or resold outside the country of original purchase ApniCure shall examine any Product that is returned with a Return Materials Authoriz...

Page 45: ...ther rights which vary from state to state To exercise your rights under this warranty please contact ApniCure Returns Policy The Winx Sleep Therapy System is considered personal medical treatment and...

Page 46: ...40 PN 12149 B indd 40 4 23 13 11 53 AM...

Page 47: ...ubjects not willing to comply with other non surgical treatment Male and female subjects were included without discrimination by gender and subjects of all races and ethnicities were equally eligible...

Page 48: ...ications likely to affect neurocognitive function and or alertness Patients on stable selective serotonin reuptake inhibitor SSRI therapy for 3 months and who are expected to remain on therapy for the...

Page 49: ...ts with inadequate mouthpiece fit and eliminate subjects meeting exclusion criteria that could only be detected functionally such as nighttime mouth breathing and inadequate nasal patency One night ho...

Page 50: ...point Cohort N 63 Primary Endpoint Cohort at 28 days PE Completers N 57 ITT Cohort at 28 days N 78 ITT Completers N 69 ITT Cohort N 78 64 Subjects 60 93 8 S3 Screen Fail Winx Fit Criteria 4 hrs TST 14...

Page 51: ...with PSG 4 TST N 52 ITT Cohort at 28 days N 78 ITT Completers N 69 ITT Cohort N 78 64 Subjects 60 93 8 S3 Screen Fail Winx Fit Criteria 4 hrs TST 14 4 hrs vacuum time 21 mouthpiece fit 8 4 hrs vacuum...

Page 52: ...y treatment with the Winx System see Tables 1 4 TABLE 1 FIRST TREATMENT NIGHT AND DAY 28 TREATMENT NIGHT AHI RESULTS PRIMARY ENDPOINT COHORT Control Night Median Q1 Q3 Treatment Night Median Q1 Q3 Med...

Page 53: ...nge Q1 Q3 Median of Change Q1 Q3 Control Night vs First Treatment Night N 78 AHI 31 0 18 8 51 0 15 3 7 5 36 6 10 7 23 2 0 9 41 5 70 6 2 9 p value 0 0001 0 0001 Control Night vs Day 28 Treatment Night...

Page 54: ...ian Change Q1 Q3 Median of Change Q1 Q3 Control Night vs First Treatment Night N 63 ODI 22 7 11 7 41 6 12 0 5 7 23 9 6 5 18 3 2 2 41 9 63 5 9 5 p value 0 0001 0 0001 Control Night vs Day 28 Treatment...

Page 55: ...TREATMENT NIGHT AHI RESULTS IN SUBJECTS THAT MET CLINICAL SUCCESS N 26 Control Night Median Q1 Q3 Treatment Night Median Q1 Q3 Median Change Q1 Q3 Median of Change Q1 Q3 AHI 26 2 19 8 45 3 5 7 3 6 10...

Page 56: ...stopping their OSA treatment for two weeks and therefore their baseline ESS scores reflected the results of prior treatment Subgroup 2 One subject had missing data thus was not included in the analysi...

Page 57: ...51 Notes PN 12149 B indd 51 4 23 13 11 53 AM...

Page 58: ...52 Notes PN 12149 B indd 52 4 23 13 11 53 AM...

Page 59: ...PN 12149 B indd 53 4 23 13 11 53 AM...

Page 60: ...patents 8 122 889 and 8 122 890 Additional patents and design registrations pending Winx the Winx logo and the ApniCure logo are trademarks of ApniCure Inc PN 12149 A 900 Chesapeake Drive Redwood Cit...

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