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Apnicure Winx User Manual

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

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  • 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 Sleep Therapy System User Guide This User Guide contains instructions for using the Winx Sleep Therapy System. ® Read all Instructions for Use before using the system. 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: Table Of Contents

    Table of Contents  Before you begin using the Winx Sleep Therapy System Description of system Winx Sleep Therapy System Components Winx Sleep Therapy System Console Icons and States General Warnings and Precautions  Instructions for using the Winx Sleep Therapy System...
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  • Page 7: Before You Begin Using The Winx Sleep Therapy System

    The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults. Contraindications The Winx Sleep Therapy System should not be used to treat central sleep apnea (CSA), or by anyone who: • H as a severe respiratory disorder, such as severe lung disease, pneumothorax, etc. • Has loose teeth or advanced periodontal disease.

  • Page 8: Winx Sleep Therapy System Components

    Reservoir After Ejection Reservoir Ejection Button Reservoir Front View Back View Power Cord Jack POWER CORD Data Card/USB Port Cover Note: This is the only power cord that you can use with your Winx Sleep Therapy System. PN 12149-B.indd 2 4/23/13 11:53 AM...
  • Page 9 Winx Sleep Therapy System Components TUBING MOUTHPIECE HOLDER MOUTHPIECE SOFT CASE Lip Seal Arched Pad 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. PN 12149-B.indd 3 4/23/13 11:53 AM...

  • Page 10: Winx Sleep Therapy System Console Icons And States

    Winx Sleep Therapy System Console Icons and States Empty/ partially (Not lit) full Clean Reservoir soon icon Clean (Not lit) (Not lit) Reaching Warming Power Vacuum Level target icon icon vacuum At target Ready vacuum Extended Needs vacuum attention break (Periodic flash) PN 12149-B.indd 4...

  • Page 11: General Warnings And Precautions

    WARNINGS (Preventing electrical shock): • D O 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.
  • Page 12 WARNINGS (Possible health risks): • U se of the Winx Sleep Therapy System may cause: ° Oral tissue or dental discomfort. ° Jaw discomfort. ° Oral tissue irritation. ° Blood in mucus. ° Keratosis (skin overgrowth). ° Headache. ° Nasal congestion. ° Gingival or dental soreness. ° P ain or soreness to the temporomandibular joint (TMJ) - the joint that connects the jaw to the skull. ° Excessive salivation.
  • Page 13 • D evice effectiveness has not been assessed in patients with nighttime mouth breathing. CAUTION (Preventing damage to the system): • D O NOT modify the Winx Sleep Therapy System (console, mouthpiece, or tubing) in any way. Use only ApniCure replacement components. • D O NOT use or interchange any components of the Winx Sleep Therapy System with other sleep apnea devices (CPAP machines, masks, mouthpieces, dental appliances, etc.).
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  • Page 15: Instructions For Using The Winx Sleep Therapy System

    Instructions for using the Winx Sleep Therapy System  Set up the console. a. P lace the console close to your bed on a nearby nightstand or on the floor. Make sure the console is on a level surface and at least a few inches away from anything that might interfere with operation. DO NOT cover the console with anything that might interfere with system operation, such as a blanket, sheet, towel, etc.
  • Page 16 d. Fully insert the tubing into the console as shown. e. Insert the tubing connector into the mouthpiece connector as shown. 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. Tubing Connector Mouthpiece Connector PN 12149-B.indd 10 4/23/13 11:53 AM...
  • Page 17 ON. Note: If the power icon is flashing yellow, there is a problem with your console. Turn the Ready console OFF. Unplug the power cord from the wall outlet and then plug it back in. Turn the console back ON. If the power icon continues to flash, DO NOT use the system. Contact Winx Customer Service at 888-986-6275 or 650-361-9300. Needs C heck the fill level of the reservoir. attention The reservoir traps any excess 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.
  • Page 18 Insert the mouthpiece. Always brush your teeth and check your mouthpiece for damage prior to use. If you find any damage that you think will impact the performance of the system, DO NOT use the mouthpiece. Contact Winx Customer Service at 888-986-6275 or 650-361-9300. Try inserting the mouthpiece while sitting in an upright position until you become comfortable with Lip Seal placement. • H old the 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.
  • Page 19 This will occur during system start-up (or ramp up) and may also occur during the use of the Winx Sleep Therapy System. If you have difficulty maintaining target vacuum ( ) during use, refer to the troubleshooting guide under “cannot feel vacuum in mouth”...

  • Page 20: Disconnecting The System

    Continue breathing through your nose and lie down to sleep. Disconnecting the system When you wake up and are ready to start your day, remove the mouthpiece and place it in the mouthpiece holder. Push the console power button to turn the system OFF. The mouthpiece and reservoir should be cleaned daily prior to the next use. If you wake up in the middle of the night and need to get up for a brief Tubing Mouthpiece...

  • Page 21: Preparing Your System For Next Use

    Preparing your system 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.indd 15 4/23/13 11:53 AM...
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  • Page 23: Care And Maintenance Of Your Winx Sleep Therapy System

    Care and maintenance of your Winx Sleep Therapy System  After each use, you should clean your mouthpiece and the reservoir: Cleaning your mouthpiece. Disconnect the mouthpiece from the tubing. Rinse the mouthpiece in warm tap water. Shake off any excess water, and then dry with a clean towel. Store your mouthpiece in the mouthpiece holder, away from direct heat or sunlight, and away from pets.

  • Page 24: Cleaning The Reservoir

    Cleaning the reservoir To clean the reservoir, you will need to remove it from the console. Press the reservoir ejection button next to the reservoir on the top of the console. The reservoir will pop up. Remove the reservoir from the console. Remove the lid by turning it counter-clockwise.

  • Page 25: Cleaning Your Console

    Cleaning your console The console can be wiped down as needed with a damp cloth. DO NOT submerge in water or use cleaning solutions to clean the console. Once a week you should flush the entire system: Flushing the entire system Connect the mouthpiece to tubing, and place the tubing on a flat surface.
  • Page 26 Place the mouthpiece upside down in the holder so that the mouthpiece is completely immersed in water. Turn the console ON. Water will start to drain from the holder, through the mouthpiece and tubing and into the reservoir. After about 30 seconds, there should be very little to no water left in the holder.

  • Page 27: Replacing Your Mouthpiece And Tubing

    Replacing your mouthpiece and tubing You should replace your mouthpiece and tubing every 3 months. Contact Winx Customer Service at 888-986-6275 or 650-361-9300 if you have any questions on how to order your replacement parts. Remove the tubing by pulling the connector apart from the console.

  • Page 28: Removing And Replacing The Data Card

    Removing and replacing the data card O pen the protective cover on the back of the console by lifting up on the bottom edge. The protective cover will stay attached to the back of the console. Press the data card into the console with your finger and then release. The card will be ejected.  Grasp the end of the card and remove it from the console. I nsert a new data card by pushing the card into the console data card slot until it clicks into place. Note: • A ll other ports near the data card slot are for physician use only. DO NOT connect cables during normal use.

  • Page 29: Disposal

    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...
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  • Page 31: Troubleshooting

    • M ake sure all connections are properly seated. makes a leaking or where the • C heck tubing for cracks/leaks. If you find a crack noise tubing connects or leak, you may need to replace the tubing. to the console and Contact Winx Customer Service at 888-986-6275 mouthpiece or 650-361-9300. A leak in the console • M ake sure reservoir lid is fully tightened and that the reservoir is completely seated within the console. • I f you cannot find the source of the leak, contact Winx Customer Service at 888-986-6275 or 650-361-9300.
  • Page 32 • I f the system has not reached the target vacuum level for two hours, the console will turn itself off automatically. • I f 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 650-361-9300. • I f the vacuum icon is flashing yellow periodically ( there has been an extended break in vacuum pressure for over 2 hours. Press the power button to turn the console...
  • Page 33 Problem Possible Cause Solution Cannot feel Mouthpiece not • M ake sure lip seal is positioned between lips and teeth. vacuum sitting correctly • M ake sure there are no tears or other damage to the lip seal. in mouth/ in mouth or • M ake sure the mouthpiece is oriented correctly within your Cannot not providing a mouth. The arched pad should be facing up toward the maintain proper seal roof of your mouth, and the pad should rest in the back of target your mouth.
  • Page 34 Possible Cause Solution Console does Console power • M ake sure power cord is fully seated into console and not power cord not wall outlet. The green LED near the power jack on the connected back of the console will be lit. • If the console still does not power ON, contact Winx Customer Service at 888-986-6275 or 650-361-9300. PN 12149-B.indd 28 4/23/13 11:53 AM...
  • Page 35 ), turn the flashing yellow required console OFF. Unplug the power cord from the wall icon ( outlet and then plug it back in. Turn the console ON. If the power icon continues to flash yellow, contact Winx Customer Service at 888-986-6275 or 650-361-9300. Problem Possible Cause Solution Mouthpiece Improper placement • R eview steps for proper mouthpiece placement.
  • Page 36 PN 12149-B.indd 30 4/23/13 11:53 AM...

  • Page 37: System Specifications

    System specifications  System specifications AC Power Consumption 100-240 V AC, 50/60 Hz, 200 mA DC Power Consumption 6.2 V DC, 1100 mA Dimension (Console) 5.6" x 3.7" x 3.8" (143mm x 94mm x 97mm) Weight (Console) 1.4 lbs. (0.65 kg) Vacuum Setting 20 inH 0 (51 cmH Vacuum Accuracy +/- 10% Operating Temperature & Humidity 5 to 40°C and 15 to 95% humidity (noncondensing) Storage Temperature & Humidity...
  • Page 38 Voltage fluctuations/ flicker emissions Complies EN 61000-3-3 Warning: The use of accessories, transducers and cables other than those specified with the exception of transducers and cables sold by ApniCure as replacement parts for internal components, may result in increased emissions or decreased immunity of the Winx Sleep Therapy System. Warning: The Winx console should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the console should be observed to verify normal operation in the configuration in which it will be used. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the console. Warning: Monitor nearby electrical equipment for normal operation. The Winx console may interfere with other equipment. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the console or other equipment.
  • Page 39 Line to Ground Voltage dips, short <5 % U <5 % U If the user of the Winx Sleep Therapy System requires interruptions and voltage (>95 % dip in U (>95 % dip in U continued operation during power mains interruptions, it variations on power supply for 0.5 cycle...
  • Page 40 System is used exceeds the applicable RF compliance level above, the Winx Sleep Therapy System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Winx Sleep Therapy System.
  • Page 41 Winx Sleep Therapy System The Winx Sleep Therapy System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Winx Sleep Therapy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Winx Sleep Therapy System as recommended below, according to the maximum output power of the communications equipment.
  • Page 42 Symbols Caution, consult accompanying Class II (Double insulation) documents Consult instructions for use Type BF Medical Equipment Direct current USB (Universal Serial Bus) SD card* Temperature limitation *Standard capacity SD card 2GB or less Manufacturer Serial number Catalog number Data ports for physician use only CAUTION: Federal Law restricts this Lot number/Batch code device to sale by or on the order of a...
  • Page 43 • M outhpiece – 30 days from date of sale to patient • T ubing – 30 days from date of sale to patient Should the Product fail to conform to the above 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 made by the initial customer of record, based on assigned serial number, lot number or warranty registration.
  • Page 44 • T his is a limited warranty and does not cover: a. A ny damage caused as a result of improper use, accident, neglect, abuse, modification, water ingress or alteration of the Product; b. Repairs carried out by any service organization that has not been expressly authorized by ApniCure to perform such repairs; c. A ny damage or contamination due to cigarette, pipe, cigar or other smoke; and d. A ny components of the Product other than the Console, Mouthpiece, or Tubing.
  • Page 45 (b) indirect, punitive, incidental, reliance, special, exemplary or consequential damages including, but not limited to, loss of revenues or profits, (c) any direct damages in excess of the amount paid to ApniCure with respect to the particular Product giving rise to such damages, even if such party has been advised of the possibility of such damages.
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  • Page 47: Appendix

    Appendix Clinical Data The ATLAST Study was a four-week, multi-center, prospective, open label, randomized first-night order of control vs. treatment, single-arm trial of the Winx Sleep Therapy System for the treatment of obstructive sleep apnea. The objective of the study was to demonstrate safety and effectiveness of the Winx Sleep Therapy System. Subject Population The subject population included subjects with OSA. Subjects could be: • t reatment naïve, • C PAP failures, or subjects not willing to comply with CPAP treatment, • o ther non-surgical treatment failures, or subjects 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 to participate. Inclusion Criteria • S ubject is between the ages of 18 and 80. • D iagnosis of OSA, based on ODI 10-60 (as assessed per home screening night). • S ubject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
  • Page 48 • O ral cavity infection or any other oral or dental condition or problem that would limit subject use of the Winx Sleep Therapy System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Winx Sleep Therapy System. • P rior use of the Winx Sleep Therapy System. • H istory of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
  • Page 49 (such as nighttime mouth breathing and inadequate nasal patency). One night home use of the Winx System with actigraphy to screen for proper fit including maintenance of oral vacuum was conducted. The subject was only given the Winx System, actigraph, and instructions for home use; an oximeter was not included. Subjects had to have had a total of at least four hours of sleep time. The sleep lab staff measured the total sleep time using actigraphy, and the oral vacuum stability using the Winx System console when the subject returned the equipment.
  • Page 50 • 4 (1.8%) Lost to follow-up Safety Cohort N=146 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 time & mouthpiece fit (17) •...
  • Page 51 N=146 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 time & mouthpiece fit (17) • 2 (3.1%) Voluntary decision: no longer interested (1);...
  • Page 52 Clinical Success was observed in 41.3% (4/15 mild, 10/18 moderate, 12/30 severe) of the Primary Endpoint Cohort comparing First Treatment Night with Control. Clinical Success was observed in 38.5% (5/16 mild, 10/23 moderate, 15/39 severe) of the Intent-to-Treat Cohort comparing Day 28 Treatment Night with Control. AHI and ODI were significantly reduced by treatment with the Winx System (see Tables 1-4). TABLE 1: FIRST TREATMENT NIGHT AND DAY 28 TREATMENT NIGHT AHI RESULTS...
  • Page 53 TABLE 2: FIRST TREATMENT NIGHT AND DAY 28 TREATMENT NIGHT AHI RESULTS (ITT COHORT) Control Night Treatment Night Median Change Median of % Change Median Median (Q1 – Q3) (Q1 – Q3) (Q1 – Q3) (Q1 – Q3) Control Night vs First Treatment Night (N= 78) 31.0 15.3 -10.7 -41.5 (18.8, 51.0) (7.5, 36.6) (-23.2, -0.9) (-70.6, -2.9) p-value <0.0001...
  • Page 54 TABLE 3: FIRST TREATMENT NIGHT AND DAY 28 TREATMENT NIGHT ODI RESULTS (PRIMARY ENDPOINT COHORT) Control Night Treatment Night Median Change Median of % Change Median Median (Q1 – Q3) (Q1 – Q3) (Q1 – Q3) (Q1 – Q3) Control Night vs First Treatment Night (N= 63) 22.7 12.0 -6.5 -41.9 (11.7, 41.6) (5.7, 23.9) (-18.3, 2.2) (-63.5, 9.5) p-value <0.0001...
  • Page 55 -48.1 (12.7, 40.6) (6.2, 21.7) (-23.8, -0.1) (-72.5, -1.0) p-value <0.0001 0.0002 p-value = signed rank test In the 26 subjects who achieved Clinical Success at the First Treatment Night in the Primary Endpoint Cohort, the median change of AHI from Control Night to First Treatment Night was significant (p < 0.0001). This group of subjects is relevant because it reflects the most likely users of the Winx System, since non-responders will choose other treatment options. (See Table 5) TABLE 5: FIRST TREATMENT NIGHT AHI RESULTS IN SUBJECTS THAT MET CLINICAL SUCCESS Control Night Treatment Night Median Change Median of % Change Median Median (Q1 – Q3) (Q1 – Q3) N=26 (Q1 –...
  • Page 56 Forty-seven ITT Cohort subjects that completed the ESS were treatment naïve or stopped using their OSA treatment at least two weeks prior to their first visit, and therefore had untreated-baseline ESS scores (Subgroup 1). Twenty-two ITT Cohort subjects completed the ESS without 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 analysis. With treatment, improvement in ESS was seen in Subgroup 1 and maintenance of ESS was observed in Subgroup 2. (See Table 6) TABLE 6: EPWORTH SLEEPINESS SCALE Primary Endpoint Cohort ITT Cohort Subgroup 1* Subgroup 2** Subgroup 1* Subgroup 2**...
  • Page 57 Notes PN 12149-B.indd 51 4/23/13 11:53 AM...
  • Page 58 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 Redwood City, CA 94063, USA p. 650.361.9300 toll-free (USA). 888.986.6275 © ApniCure, Inc. All rights reserved. The product described herein is covered by one or more of the following U.S. 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 PN 12149-B.indd 54 4/23/13 11:53 AM...

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