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 User Instructions and Important Safety Information

WARNING

The Voutia™ System is designed to be used by individuals suffering from a perceived or actual lack of sufficient saliva production.  Use by individuals with an impaired swallowing ability, risk of aspiration, impaired mental status, or have failed a physician prescribed swallow test is not recommended.

This device is not waterproof.  Do not immerse the device or allow it to be in direct contact with fluids to avoid potential damage to the unit.

When using the Voutia™ System, basic safety precautions should always be observed, including the following:

  1. Read all instructions before using the Voutia™  System.
  2. Only use the Voutia™ System for its intended use.
  3. Do not allow the Voutia™ System to be used as a toy.
  4. To protect against the risk of electric shock, do not immerse any part of the Voutia™ System in water or other liquids.
  5. Never yank cord to disconnect from any outlet.  Grasp plug and pull to disconnect.
  6. Do not allow the tubing or cords to contact hot surfaces.
  7. Always disconnect the Voutia™ System from its power source before filling the bottle.
  8. Do not operate the system with a damaged cord or plug, or if the appliance or any other part of the Voutia™  System has been dropped or damaged. To avoid risk of electric shock, do not disassemble or attempt to repair any component of the Voutia™ System.  Return the Voutia™  System to the manufacturer for inspection and repair or replacement.
  9. Do not leave the Voutia™ System unattended while connected to power sources.
  10. Use caution when emptying the unit.  Do not allow water to drain into or on the components.
  11. Do not operate in the presence of explosive and/or flammable fumes.
  12. This device is intended for individual personal use.  Do not share the Voutia™ System among different individuals.  Follow all instructions included with the unit/system.
  13. NEVER use any chemicals or substances in the Voutia™ System other than the recommended cleaning solution or potable water. 
  14. Use of unauthorized substances can damage the device and void any warranty.

To reduce the risk of fire, electric shock, or injury:

  • Do not leave the Voutia™ System plugged in while unattended.
  • ALWAYS unplug from power sources when refilling the bottle.
  • Use only as described in the enclosed manual or under the written advisement of a licensed Physician or Dentist.
  • DO NOT pull cord or tube, use cord or tube as a handle, close a door on the cord or tube, or pull cord or tube around sharp edges or corners. Keep cord and tube away from heated surfaces.
  • DO NOT use extension cords or outlets with inadequate current carrying capacity.
  • Do not unplug by pulling the cord.  To unplug, grasp the plug, not the cord.
  • Do not handle the Voutia™ System or plug with hands that are damp or wet.
  • Do not put objects into openings or use if any opening is blocked.
  • Store the Voutia™ System indoors in a cool dry area.
  • DO NOT use cleaning solutions (other than what is recommended by the manufacturer).
  • Do not attempt to fill the Voutia™ System under a faucet.  Always use a measuring cup.
  • KEEP THE Voutia™ System OUT OF THE REACH OF CHILDREN.  USE FOR AND WITH CHILDREN UNDER 18 SHOULD ONLY BE DONE UNDER THE RECOMMENDATION OF A PHYSICIAN OR DENTIST AND WITH CLOSE ADULT SUPERVISION. FOLLOW ALL ENCLOSED INSTRUCTIONS.

SAVE THESE INSTRUCTIONS

FOR FUTURE REFERENCE

THE VOUTIA™  SYSTEM IS FOR SINGLE PATIENT USE ONLY

DO NOT SHARE THE DEVICE WITH OTHERS

The device should not be immersed in liquids or exposed to precipitation.  Use of the Voutia™ System should not be done in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.  

Maximum Time of Continuous Use of The Voutia™ System:  24 hours a day.

This system is designed to deliver potable fluid to the oral cavity.  It may be used for any extended period of time.  Users should take care to note if the fluid being delivered states a maximum allowable amount within a certain period of time.  DO NOT EXCEED RECOMMENDED FLUID AMOUNTS OR DOSEAGES FROM ANY MANUFACTURER OR SUPPLIER.

ADDITIONAL IMPORTANT SAFEGUARDS

  1. To avoid circuit overload, DO NOT operate another appliance on the same socket (circuit)
  2. DO NOT leave the Voutia™ System unattended when the system is connected to a power supply/electrical outlet.

The manufacturer accepts no responsibility for damage caused to objects, materials, animals, or persons due to the inappropriate use of the Voutia™ System, and/or through ignoring the advice and recommendations set down in the Owner’s Manual.  Specific written recommendations for use by a licensed Physician and/or Dentists should still adhere to the manufacturer’s basic operating instructions.

Use of prescription medications or saliva substitutes is considered “off label” use and is not recommended.

The manufacturer accepts no responsibility for damage caused to objects, materials, animals, or persons due to  the use of saliva substitutes and/or prescription medications independently or under the guidance and supervision of a licensed health care professional that deviate from use guidelines set forth in this document.

Thank You for Choosing Voutia™

Your Voutia™ System is a very versatile device.  Used correctly, it is intended to make life more comfortable for individuals suffering from the debilitating effects of dry mouth (xerostomia).  Take care to read all of the information contained with this unit before using it.

  • Inconspicuous size and design
  • Hands free headpiece
  • Portable (with the internal  rechargeable battery )
  • Long battery life
  • Operation from home with DC power plug
  • 9 customizable flow settings (0.1 to .9 ml/min)
  • Flow settings are saved in 4 different selection modes

 

Instructions for the Operation and Maintenance

of the Voutia™ System

Maintenance and Cleaning

The device should be cleaned BEFORE ITS FIRST USE and weekly thereafter.  This helps to prevent germs from growing in the bottle and the tube.

DO NOT WEAR THE UNIT DURING THE CLEANING PROCESS

To disinfect, follow these steps once per week:

Cleaning

The recommended cleaning protocol is intended to clean the reservoir, tubing, attachment components and pump.  These are the only components that come in contact with the fluid to be delivered to the oral cavity.  Cleaning is essential to ensure safe use of your device.

  1. Users should boil water for 10 minutes and allow it to cool to room temperature  before proceeding. Then, safely transfer this water to the 16 oz. reservoir bottle using a measuring cup.
  2. Add 2 ml of household chlorine bleach to the reservoir. Replace the reservoir cap and tubing. 
  3. Attach the pumping unit to its included wall power adapter/charger as shown in the setup instructions and plug into a wall outlet.
  4. Attach the reservoir to the inlet port and the headset to the outlet port on the main pump housing.  Position the polyimide tube end such that the fluid pumped during this cleaning process is collected and/or disposed of in a manner deemed appropriate by your locality.  Cleaning solutions will not be reused.
  5. Power on the device and allow it to run on its maximum setting #9 (0.9 ml/min) for 1 (one) hour.  (Please note, not all of the cleaning solution in the reservoir will be used.)
  6. After 1 (one) hour, power the device off and detach the reservoir from the device.
  7. Remove the cap and dampen a soft cloth or paper towel with some of the remaining disinfecting solution.  Use this dampened cloth or paper towel to gently wipe down the outside of the tube that goes into your mouth and allow a minimum of 10 minutes for it to dry.  
  8. Dispose of all remaining cleaning solution in a manner deemed appropriate by your locality. 
  9. Rinse the headset tubing, reservoir bottle and the reservoir tubing/cap section several times with clean, potable drinking water to remove any residual cleaning solution.
  10.  Fill the reservoir with potable drinking water, reattach the cap/tubing section and then reconnect the closed reservoir/cap/tubing component to the inlet port of the device.  NOTE: PRIOR TO REATTACHING TO THE INLET PORT, USE AN ABSORBANT CLOTH OR PAPER TOWEL TO BLOT OFF ANY VISIBLE DISINFECTING SOLUTION PRESENT ON THE INLET PORT.
  11.  Power on the device as before and run the device on its maximum setting 9 (0.9 ml/min) for a minimum of 20 (twenty) minutes. NOTE: DO NOT DETACH THE HEADSET FROM THE OUTLET PORT AT ANY TIME DURING THIS PROCEEDURE.

The maximum amount of liquid contained in the tubing and pump is less than 1 ml.  As all components in the fluid pathway are nonabsorbent, running potable water from the rinsed reservoir/cap/tubing component for a minimum of 20 (twenty) minutes will flush out all tubing and the pump system of any residual cleaning solution with 18 (eighteen) ml of potable fluid.

 

MAIN UNIT SETUP

ATTACHING THE RESERVOIR BAG/BOTTLE

When looking at the front of the Voutia™, you will notice 2 inlet ports located at the top.  The right port (IN) is where you attach the reservoir.  The left port (OUT) is for attaching the headset/tubing.

Fluid will flow in from the right port, through the pumping system and exit at the left port.

To attach the reservoir, do the following:

  1. Locate the right “IN” port and the small tube coming from the reservoir bag.
  2. Using the included Luer adapter, attach the reservoir tube to the Voutia™ top right “IN” port. (do not overtighten)
  3. When ready for use, remove the reservoir cap and fill the reservoir with the appropriate fluid.
  4. Replace the cap and follow the instructions for attaching the headpiece tubing before powering on Voutia™.

SETTING UP THE HEADPIECE

  1. Gently hold the flexible ear loop with your fingers.
  2. Carefully unwind the tubing attached to it so there are no bends. (do not use much force)
  3. Place the flexible ear loop over the ear of your choice with the smallest tube facing your mouth.
  4. Take the very small tube and put it in your mouth between your cheek and teeth. Do not chew on the tube.
  5. If desired, the thin tube to the mouth can be threaded between the lower teeth and positioned under the tongue.
  6. If desired, the larger tube can be run under a jacket or shirt to hide it.  Have it come out near where it can hook to the pump. (It is recommended that the tube go between an undergarment and the shirt to avoid rubbing on your skin or catching.)
  7. Attach the larger tube’s end to the top left “OUT” port  with the Luer attachment, just as the reservoir tube was attached.  (Do not over tighten)

PLACE THE UNIT ON A STABLE TABLE/NIGHTSTAND IF YOU ARE GOING TO SLEEP.

IF YOU ARE GOING TO BE WALKING AROUND, ATTACH IT TO YOUR BELT WITH THE BELT CLIP OR USE A PREFERED CARRY BAG.

The Voutia™ Controls

On the front of the Voutia™ device, you will notice a LCD display, four (4) directional arrows, and a center button with a circle on it.  This is where you will be able to turn on/off the device and make your flow selections.

Powering on the Voutia™ Using its Internal Battery     
Locate the center button with the round circle.
  1.  Press and hold the center button for 2-3 seconds.
  2.  The unit will power on, go through a systems check and show the display.
  3.  If a mode is not selected, the device will enter a sleep mode after 30 seconds.
  4.  If a flow rate was selected at an earlier use, the system will begin pumping at that setting immediately.
  5.  If you do not wish the unit to pump, press the “down” arrow until the number “0” is displayed.

Powering and Charging the Voutia™ System from External Power

  1. Check to make sure the Voutia™ Device is not powered on.
  2. Plug in the included wall adapter to a standard home wall outlet (110 volt)
  3. Plug in the other end of the power adapter to the power jack on the outside of the Voutia™ Device. (Do not force the plugs together; slowly rotate the plug as you apply light pressure.  There is only 1(one) correct position and they will slide together when aligned.)
  4.  The Voutia™ unit will power on when attached to the wall charger.
  5.  The unit will go through a systems check and show “STANDBY” the display.

NOTE:  If you turn off your Voutia™ while charging, you must disconnect the charger from the unit in order to turn the unit back on.

While connected to an outlet, the Voutia™ System will operate normally and charge the internal Lithium Polymer battery at the same time. You should not need to go without the system while charging.

Display and Display Lighting

The Voutia™ LCD display will light up to help you read it when you power on the device or adjust a setting.  Because this lighting draws extra power from the internal battery, the Voutia™ System is designed to turn off the backlight and display after approximately 30 seconds if no buttons are pressed.  Optimizing battery life for pump function is important so you can get maximum use from each charge.

If you power on your Voutia™ System but no not select a mode, after several seconds, the unit will go into “STANDBY MODE.”  This also protects the battery from excessive drain.  To exit the “STANDBY MODE,” simply press any one of the keys and Voutia™ will “wake” up

Navigating the Display

Use the left and right arrow keys to move between the preprogrammed modes (shown at the top of the LCD display) depending on your activity and needs.

                                SLP = Sleep mode, (0.1 to 0.3 ml/min recommended)

                                SIT = Resting mode, (0.5 ml/min recommended)

                                DAY = Daytime mode, (0.4 to 0.7 ml/min recommended)

                                EXE =Exercise mode, 0.7 to 0.9 ml/min recommended)

PLEASE NOTE: EACH PERSON IS UNIQUE AND THE SELECTION RECOMMENDATIONS ARE ONLY GUIDELINES.  SELECT THE RATE THAT PROVIDES THE BEST RELIEF, HOWEVER, DO NOT EXCEED THE RECOMMENDED RATE WHEN SLEEPING.

A full description of what mode you have selected will appear in the lower left of the LCD display. A battery monitor bar is located in the lower right corner of the display so you will know the Voutia™ battery charge status. Selectable modes are:  Sleep, Sitting, Daytime, and Exercise.

Once started, your Voutia™ System will begin to pump at the selected rate and save this setting for future use.  Make sure you are wearing the accompanying headpiece or fluid spilling will occur.

Adjusting the Rate for Individual Needs

Each user has unique personal needs and desires.  The Voutia™ System understands this and may be adjusted to slightly increase or decrease the rate of each preprogrammed mode.  If you find that a slight increase or decrease is desired, please do the following:

  1. Locate the up and down arrows on the front of the unit.
  2. To slightly increase fluid to the mouth, press the “up” arrow key facing the LCD display.
  3. To slightly decrease the fluid to the mouth, press the “down” arrow key.

Turning the Power Off

To shut off your Voutia™ System, simply locate the center key with the circle on it.  Press and hold down the center key marked “0” for 4- 5 seconds.  The device should power off.

IMPORTANT CHARGING INFORMATION

  • Do not charge the device near flammable materials
  • In any case where the Voutia™ System becomes damaged, hot, or swells, discontinue its use immediately.
  • If the housing becomes damaged and internal components of the battery come in contact with your skin, wash the area with soap and water immediately. 
  • If contact with the eyes occurs, flush eyes with generous amounts of water for 15 minutes and seek medical attention.
  • Damaged Vouti devices should be returned to the manufacturer for repair or replacement.
  • DO NOT USE A DAMAGED DEVICE

FREQUENTLY ASKED QUESTIONS AND TROUBLESHOOTING


 
I set up and turned on my device and nothing is coming out.

  • When you first attach the tubing and turn on your device, all of the tubes are empty.  Because the device does not pump water fast, it can take a few minutes to fill and begin wetting the mouth. 
  • Check to make sure there is no leak at where the tubes meet the pump. If so, slightly tighten the connection some more.
  • Watch the tube to see if the water is moving through it
  • Perform the priming procedure for the pump shown in figures 3 & 4 below.
  • Apply light suction to the tube in your mouth. This will speed up priming of the pump
I plugged in my device and pressed the key but nothing happens.
  • Check to make sure wall plug is all the way plugged into the outlet
  • Check to make sure the battery is charged on the unit by looking at the lower right display.
  • Check the speed setting.  Sleeping mode is very slow.   The tubing may take more time to fill.
I hear the pump working but no water is coming out.
  • Check to make sure the tubes are hooked to the correct ports of the pump       
  • Check the tubing to make sure there is no bend stopping the flow
  • Look at the small tube that goes in your mouth to check for any kinks
  • Check the bottle to make sure it is full of water
  • Gently suck on the small tube to help pull fluid from the reservoir to the pump.
The plug came out of the device while I was using it and it cut off.
  • If the unit becomes unplugged during use, turn the device off before reattaching the power cord to the unit. The device should not be harmed if this occurs.
How long will my Voutia™ device last?
  • By adhering to the recommendations in this document, your Voutia™ device should give you several years of operation.  The pump is rated to last > 5000 hours and the battery for 500 charges or approximately 2-3 years
  • In the event your pump stops functioning or your battery fails to hold a charge, simply return it to the supplier who can replace either for a nominal parts and labor fee.  There is no need to purchase a completely new Voutia™ device in these situations.

In the event that you are unable to get the device to run as you need, please contact the manufacturer so arrangements can be made for instruction, a replacement or repair.  Do not attempt to repair the device yourself as this will void any warranties.

STORAGE OF THE UNIT

The Voutia™ Device, Headpiece and Tubing should not be stored unless these steps are performed.  Storage should be in a cool dry place.

  1. Pour out all contents of the bottle.
  2. Attach the headpiece to the pump and perform the disinfection procedure described on page 3.
  3. After the bottle is emptied, run the device AT ITS MAXIMUM SETTING OF 9 with the headset attached for 10 minutes to clear any liquid out of the tubes.
  4. Detach the reservoir and headset from the main pumping unit.
  5. Attach the included 3cc syringe to the outlet port and gently pull the plunger up to draw any residual fluid from the pumping system that may remain.
  6. Attach the 3cc syringe to the adapter on the headset and gently draw back on the plunger to remove any residual fluid in the headset.
  7. Disconnect all power sources and store the unit in a cool dry place.

NOTE:  Prior to using the unit at a later date, perform the complete disinfection procedure listed above.  The unit should then be disinfected and ready to use again.

     


     


            



Voutia Setup Guide With Pictures

Step 1:

  1. Locate the reservoir bottle, 1 (one) clear adapter and your Voutia Unit.
  2. Attach the clear adapter to the BLUE connector on the reservoir tube as shown in Fig. 1. (Do not overtighten) 
  3.  Fill your reservoir bottle with potable tap or bottled water.

(There is no need to turn on the device yet)

Fig. 1

Fig. 1 


Step 2:

  1. Attach the clear adapter to the Voutia unit’s TOP RIGHT port as shown in Fig. 2. (Do not overtighten)
  2. You have successfully connected your fluid supply!!
Fig. 2

Fig. 2 


 

Step 3:

  1. Locate the 3cc syringe included with the Voutia System.
  2. Attach the syringe to the TOP LEFT port on the Voutia housing as shown in Fig. 3. (Do not overtighten)

The pump is auto-priming, but this will speed up the process.
NOTE: The Voutia system contains a backflow prevention valve.  Do not attempt to inject fluid back into the headset port.  Once water begins to enter the syringe, detach the syringe and dispose of any liquid in an apprpriate manner.

 

Fig. 3


 

Step 4:

  1. Gently pull the plunger out until you see water begin to fill the syringe as seen in Fig. 4. (There is no need to pull fast)
  2. You have successfully “primed” the pumping system.
  3. Remove the syringe and proceed to step number 5.

Note: Priming the pump is not always a necessity but is included here to show a way to speed up the pumping process
Fig. 4
Fig. 4


 

Step 5:

  1. Locate and attach the second clear adapter to the TOP LEFT port where the syringe was attached as shown in figure 5.
  2. Next, locate the included headset that has the soft silicone ear support also shown in Fig. 5.
  3. GENTLY unwind the ear support tubing taking EXTREME CARE not to kink the tan colored micro-tube.
Fig. 5

Fig. 5



Step 6:

  1. Attach the blue connector to the clear adapter as shown in Fig. 6. (Do not overtighten)
  2. Place the ear support over the ear of your choice then gently guide the tan micro-tube along your cheek and insert the free end into a comfortable location IN your mouth.

NOTE:  The micro-tube can be trimmed later to a length that is desired by the user.
Fig. 6
Fig. 6



Step 7:  Turning on the unit

Note:  Figures 7/8 do NOT show the headpiece attached

  1. Locate and press the center button on the Voutia housing shown in Fig. 7.
  2. A systems check will occur and the word “STANDBY” appears on the screen.
  3. If no arrow buttons are pressed after 20 seconds, the Voutia system will turn off to save battery power.
Fig. 7

Fig. 7


Step 8:

  1. Press the center round button or one of the up/down arrows to activate the system.
  2. The up/down arrow buttons (Fig. 8) will let users select the flow rate that best meets their need.
  3. Pressing the center button again will pause the pump and return it to “STANDBY” mode.
  4. The backlight on the system will turn off after 20 seconds to conserve battery life.  Simply press one of the buttons to turn it back on.

NOTE: Watch the headset tubing when you turn on the pump.  You should see the fluid begin to move through it.  If this is not happening, check your connections to make sure there is no leak or obstruction.

Fig. 8

Fig. 8 





Safety and Effectiveness (CFR21860.7)

This device is intended to be used for the relief of chronic dry mouth (xerostomia) encountered during waking or sleeping hours.  The developer and manufacturer recommend that users familiarize themselves with the device before use.  Instructions set forth in the enclosed user information and safety instructions should be read and understood in their entirety before beginning use.

When used in accordance to the enclosed instructions, risk of injury or illness should not occur.

 

Indications for use:

The Voutia™ system is indicated to provide relief of dry mouth by coating, moistening and lubricating oral structures thereby relieving the symptoms of xerostomia (dry mouth).

 

Additional Information:

  • This device requires no monitoring when used as intended.
  • This device is not considered a life supporting necessity.  It is designed to provide relief and comfort from dry mouth symptoms in a convenient manner.  Alternate methods of hydration and lubrication of oral structures may be used in lieu of this device such as drinking from a water bottle or use of over the counter mouth washes and lozenges.
  • There are no known adverse reactions from using this device as directed by the developer.
  • This device is not considered a prescription device per the USFDA CFR21801.109 act.  However, it may require a written prescription for reimbursement by insurance providers.

 

Contraindications:

The Voutia™ device should not be used in individuals with an impaired swallow or gag reflex or who have failed a physician prescribed swallow test.  The use of fluids other than potable water is not recommended by Virginia Head and Neck Therapeutics, LLC or the developer.  Use of fluids other than potable water should only be undertaken when supervised by a licensed healthcare provider who accepts full responsibility for any consequences arising from such use and indemnifies Virginia Head and Neck Therapeutics, LLC and its affiliates of any and all liability.

 

Disclaimer of Liability:

This device is for single patient use and should not be shared amongst others. Virginia Head and Neck Therapeutics, LLC indemnify themselves in the use of this device by others.  Any and all Claims against Virginia Head and Neck Therapeutics, LLC shall be under the jurisdiction of the Commonwealth of the State of Virginia.

Virginia Head and Neck Therapeutics, LLC acknowledge and adhere to the United States FDA in imposing the notification and other remedies (repair, replacement, refund) provisions of section 21CFR518 of the USFDA act.
Determination of replacement or repair of returned units is at the sole discretion of Virginia Head and Neck Therapeutics, LLC 

 
Contact Information:
Virginia Head and Neck Therapeutics, LLC
Jeffrey W. Cash, DDS, FICD, President
10149 Bon Air Crest Drive
North Chesterfield, VA 23235-4868
Email:  cashdds@hotmail.com
 



END