Apnicure Winx User manual

Winx Sleep Therapy System
User Guide for Patients
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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
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Table of Contents
 Before you begin using the Winx Sleep Therapy System 1
Description of system 1
Winx Sleep Therapy System Components 2
Winx Sleep Therapy System Console Icons and States 4
General Warnings and Precautions 5
Instructions for using the Winx Sleep Therapy System 9
Setting up the console and mouthpiece 9
Disconnecting 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 the entire system 19
Replacing your mouthpiece and tubing 21
Special considerations 21
  •MovingtheWinxSleepTherapySystem 21
  •DataPortsinthebackoftheconsole 21
  •Removingandreplacingthedatacard 22
  •Disposal 23
Troubleshooting 25
System specifications 31
6Appendix 41
Clinical Data 41
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Description of system
The Winx Sleep Therapy System is designed to treat obstructive sleep apnea (OSA). In obstructive sleep
apnea, the muscles of the so palate and areas near the base of the tongue relax, obstructing the airway
while you sleep. The system consists of 3 main components – a console, a mouthpiece, and tubing. The
mouthpiece is worn inside your mouth while you sleep, and is attached to the console with the tubing.
The console creates a light vacuum that gently pulls your tongue and so palate forward, creating a
positive pressure gradient that helps to 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 mouth-breathing before using the system.
Indications for use
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:
 •Hasasevererespiratorydisorder,suchasseverelungdisease,pneumothorax,etc.
 •Haslooseteethoradvancedperiodontaldisease.
 •Isundertheageof18.
For use only by order of a physician.
Before you begin using the Winx Sleep Therapy System
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Winx Sleep Therapy System Components
Note: This is the only 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 Aer
Ejection
ON/OFF Button
Reservoir
CONSOLE
POWER CORD
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MOUTHPIECE SOFT CASE
MOUTHPIECE HOLDERTUBING
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 Seal
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OFF
Reaching
target
vacuum
At target
vacuum
Extended
vacuum
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
icon
Vacuum Level
icon
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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uidstogetinsidetheconsole.Ifyouthinkwaterorotheruids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
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WARNINGS (Possiblehealthrisks):
 •Use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.
°Painorsorenesstothetemporomandibularjoint(TMJ)-thejointthatconnectsthejawtotheskull.
°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 your mouthpiece or tubing with other
patients.
•Assessmentofeectivenessshouldbeconductedbyyourphysiciantoensureadequatetreatment
eect.
•ThelongtermeectivenessoftheWinxSleepTherapySystemhasnotbeendetermined.Patients
shouldbeevaluatedtoassessongoingappropriateeectiveness.
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CAUTION:
•Physicianshouldconsiderthemedicalhistoryandconditionofthepatient,includinghistoryofasthma,
sinusitis, nasal obstruction, breathing, or respiratory disorders or other relevant health problems, and
refer the patient to the appropriate health care provider before prescribing the device.
•Intheeventofapowerfailureordevicemalfunction,removethemouthpiece.Thesystemwillnot
provideeectivetherapyiftheconsoleisnotpoweredonorfunctioningproperly.
•Patientsshouldhavedocumentedobstructivesleepapnea.
•Adequacyofnasalpatencyshouldbeassessed(asevidencedbyPeakNasalInspiratoryFlow(PNIF)
greater than 75 L/min).
•Adequacyandcomfortofmouthpiecetshouldbeascertained,includingmaintenanceoforalvacuum
during device use.
•Deviceeectivenesshasnotbeenassessedinpatientswithnighttimemouthbreathing.
CAUTION (Preventing damage to the system):
•DO NOT modify the Winx Sleep Therapy System (console, mouthpiece, or tubing) in any way. Use only
ApniCure replacement components.
•DO NOT use or interchange any components of the Winx Sleep Therapy System with other sleep
apneadevices(CPAPmachines,masks,mouthpieces,dentalappliances,etc.).
•Ifyoudroptheconsole,rstconrmthatthesystemisstillworkingproperly.Ifthesystemdoesnot
perform as expected, DO NOT use the system. Contact Winx Customer Service at 888-986-6275 or
650-361-9300.
•Cleanthereservoirlidbyrinsingwithrunningwateronly.DO NOT use instruments or devices to clean
the inside of the lid.
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1Set up the console.
a.Placetheconsoleclosetoyourbedonanearbynightstandorontheoor.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.
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 hazard.
Note: DO NOT use any other power cord with your console.
Instructions for using the Winx Sleep Therapy System
c.Opentheprotectivecoveronthebackoftheconsolebyliinguponthebottomedge.Makesurethe
data card is fully inserted into the console data card slot (see page 22).
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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.
d. Fully insert the tubing into the console as shown.
Mouthpiece
Connector
Tubing
Connector
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2Turn the console on.
Push the power button on the console to turn the unit ON. The power icon will flash blue
for a few seconds while it warms up, and then turn solid blue when the unit is fully
powered ON.
Note: If the power icon is flashing yellow, there is a problem with your console. Turn the
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ash,DO NOT use the system.
Contact Winx Customer Service at 888-986-6275 or 650-361-9300.
3Checkthelllevelofthereservoir.
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lllevelofthereservoir.Theicon
willindicatethelllevel.
If the icon is:
 •Not lit – the reservoir is ready for use. You do not need to empty the reservoir.
 •Flashing yellow – the reservoir is almost full. The console will still operate when the
icon is flashing yellow, but you should clean the reservoir as soon as you can. This will
ensure your console is ready the next time you use the system.
 •Solid yellow – the reservoir is full. The console will not operate until you clean the
reservoir.
If you need to clean the reservoir, see page 18.
Power icon Reservoir icon
Clean soon
Clean now
Empty/
partially full
(Not lit)
Ready
Warming up
Needs
attention
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4Insert the mouthpiece.
Alwaysbrushyourteethandcheckyourmouthpiecefordamagepriortouse.Ifyound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
placement.
 •Hold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.
 •Makesurethearchedpadisfacinguptowardthe
roof of your mouth. Place the mouthpiece inside
your mouth so that the lip seal sits between your
teeth and lips.
Begin breathing through your nose.
Note: •DO NOT chew on the mouthpiece
 •DO NOTwearthemouthpiecewhileeatingordrinking
 •DO NOTinsertthemouthpieceupsidedown.Makesurethearchedpad
points upward toward the roof of your mouth.
Lip Seal
Pad
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5Wait for the vacuum level on the console to reach the correct vacuum.
Wait for the vacuum level icon to turn from flashing yellow to solid green. Flashing
yellow means the console is in the process of increasing vacuum until it reaches its
pre-settargetlevel.Thiscantakeabout10-15seconds.Thevacuumleveliconwill
flash yellow whenever the vacuum is not at the pre-set target level. 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” for potential
solutions. If this problem persists, contact Winx Customer Service at 888-986-6275 or
650-361-9300.
Vacuum is applied through the hole in the arched mouthpiece pad.
Tip: To help achieve the proper vacuum, li your
tongue to the roof of your mouth and swallow.
Once vacuum is achieved, relax your tongue. The
vacuum will hold your tongue in place.
Note: You cannot adjust the vacuum level of the console. The vacuum level will
automatically reach a target level that has been pre-set.
Vacuum icon
Ready
Reaching
target
vacuum
Extended
vacuum
break
(Periodic flash)
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6Continue 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
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 needs to be removed
for a longer period of time, remove it and turn the console OFF. Simply
repeat the preceding steps when you are ready to return to bed and go
backtosleep.
Note: Aer two hours of use without having attained target vacuum, the console will automatically turn
o.Thevacuumiconwillperiodicallyashyellow( ).
Mouthpiece
Connector
Tubing
Connector
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