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WillowWood ALPHA ACLS-049-X06 Instructions Manual

Control liner system
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ALPHA® CONTROL
LINER SYSTEM
INSTRUCTIONS
WHAT'S IN THE BOX
Alpha Control Liner with Electrodes Installed
Alpha Control Module*
Alpha Control Cap*
Alpha Control Lock with Release Button*
Alpha Control Liner Fabrication Dummy Kit*
Instructions
*not included with replacement liner
ADDITIONAL MATERIALS REQUIRED
Coapt System
Batteries
Any additional desired components

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Summary of Contents for WillowWood ALPHA ACLS-049-X06

  • Page 1 ALPHA® CONTROL LINER SYSTEM INSTRUCTIONS WHAT'S IN THE BOX Alpha Control Liner with Electrodes Installed Alpha Control Module* Alpha Control Cap* Alpha Control Lock with Release Button* Alpha Control Liner Fabrication Dummy Kit* Instructions *not included with replacement liner ADDITIONAL MATERIALS REQUIRED Coapt System Batteries Any additional desired components...
  • Page 2 Symbol indicating to consult instructions for use. Symbol indicating to consult instructions for use. Symbol indicating to consult instructions for use. Symbol indicating to consult instructions for use. Symbol indicating body contact. Symbol indicating body contact. Symbol indicating body contact. Symbol indicating body contact.

  • Page 3: Table Of Contents

    CONTENTS SECTION ..........PAGE INDICATIONS FOR USE ..........4 DONNING................4 TURNING ON THE SYSTEM ........5 TRIMMING .................5 CLEANING AND CARE ..........6 ALPHA CONTROL MODULE INSTALLATION ...............8 SHAPE CAPTURE AND MODIFICATION ..........11 TEST SOCKET FABRICATION ......13 TEST SOCKET FITTING ........... 15 DEFINITIVE SOCKET FABRICATION ....

  • Page 4: Indications For Use

    INDICATIONS FOR USE The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs. DONNING Do not apply any type of lotion or powder to the residual limb or to the liner, as these products could damage the liner.

  • Page 5: Turning On The System

    • Never cut the liner distal to the electrodes. Use sharp scissors, a paper cutter, or a Hand-Held Cutting Wheel (WillowWood Part No. 700- TL002). If using the Hand-Held Cutting Wheel, place the liner on a cutting board or thick piece of plastic. Using a straight edge as a guide, roll the cutting wheel cross the liner.

  • Page 6: Cleaning And Care

    CLEANING AND CARE Proper hygiene is extremely important when using the liner. Please review these care instructions very thoroughly with the patient. Daily Cleaning Thoroughly clean the gel side of the liner. Use lukewarm tap water and a hypoallergenic body soap.
  • Page 7 Weekly Disinfection Place a small amount of Rinse off excess alcohol ethyl or isopropyl alcohol with water. on a soft, clean cloth. Dry the liner with a Gently wipe the gel clean, lint-free cloth. side of the liner for two minutes.

  • Page 8: Alpha Control Module Installation

    ALPHA CONTROL MODULE INSTALLATION Each Alpha Control Liner requires that an Alpha Control Module be installed for functionality. The liner will eventually need to be replaced, but the electrodes, module, and liner cap can be transferred to the replacement liner. Important: Use only electrodes ACL-300.
  • Page 9 To install the Module in a new liner: 1. Unscrew the liner cap, if it is in place, and set aside. If necessary, use an adjustable wrench on the flat side section of the liner cap to facilitate removal. Do not scratch the top surface of the liner cap, or you may need to replace it to ensure system functionality.
  • Page 10 4. Gently begin to push the Module into the housing (Figure 9), without rotating or bending the Module. The Module should easily slide into place in the housing. If it does not, check that the keys are aligned (note that the Module has a second semi-circular groove that does not continue the entire length, and should be positioned opposite the key).

  • Page 11: Shape Capture And Modification

    SHAPE CAPTURE AND MODIFICATION 1. Don the liner with the electrodes installed. Ensure that there are no wrinkles or air pockets between the skin and the liner. 2. Fill in the groove on the umbrella using the provided rubber bands (Figure 11).
  • Page 12 Sand down the distal end of the positive model to the umbrella transition line to create a flat surface on which to place the lock dummy (Figures 14a, 14b). 10. Place the lock dummy on the model with the hole for the lock release button in the desired...

  • Page 13: Test Socket Fabrication

    TEST SOCKET FABRICATION Note: The lock dummy is shipped with all available screws installed. The first time you use the lock dummy, you will need to remove the screws you don’t need, • If you will be mounting the lock from the distal end of the socket, you will need to remove the side screws.
  • Page 14 Fabricate the diagnostic socket. 3. Grind down to expose the screws. Remove the screws. If using the side mount screws, continue to grind around the side mount holes until the socket thickness is less than 1/8” (.125”) to ensure the proper amount of thread engagement when installing the lock.

  • Page 15: Test Socket Fitting

    TEST SOCKET FITTING Have the amputee don the liner. Have the amputee don the test socket. Make adjustments as necessary for easy donning. The lock should make a clicking noise to indicate complete donning, at which point a gentle tug can confirm that the lock is engaged.

  • Page 16: Definitive Socket Fabrication

    Note: For Steps 4-7, the terminal device should not be attached to the socket. This will allow for easier troubleshooting should any issues arise during first test fitting. Attach the terminal device on a stand or lay the terminal device on a table. Make sure all connections are completed.

  • Page 17: Repairing Worn Seams

    REPAIRING WORN SEAMS Damage to the liner seams from wear can be repaired with the same process that is used for other Alpha Liners, as long as the damage does not expose any leads or electrodes. Note: If the damage to the liner exposes leads or electrodes, the amputee should discontinue use immediately and acquire a replacement liner to prevent injury.

  • Page 18: Troubleshooting

    TROUBLESHOOTING WillowWood has partnered with Coapt to bring you the liner system to enhance your experience with the Coapt Complete Control System Gen2. If you are experiencing issues that do not appear in or are not fixed by the guide below, call customer support.

  • Page 19: Regulatory Information

    (c) a serious public health threat, please immediately report the incident by contacting WillowWood Global or, if in the EU, the authorized European Union representative and the competent authority within the member state in which the patient/user is established.
  • Page 20 WillowWood Global LLC 15441 Scioto Darby Road Mt. Sterling, OH 43143 téléphone 740.869.3377 / 800.848.4930 télécopieur 740.869.4374 www.willowwood.com Brevet www.willowwoodco.com/education-and-resources/patents Emergo Europe Westervoortsedijk 60 6827 AT Arnhem The Netherlands PN-2593-A 08 DEC 2022...

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