Atos Medical Provox LaryButton is a silicone stoma button, that maintains the opening of the stoma. It can be used to attach an HME, also in combination with Provox FreeHands FlexiVoice speaking valve. The Provox LaryButton is well suited for patients with a circumferential skin fold around the stoma (a so-called "lip") and patients with a sensitive skin.

Atos Medical Provox LaryButton Intended Use

• The Provox LaryButton is a self-retaining holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy.
• For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.
• The Provox LaryButton is intended for single patient use

How to use Provox LaryButton?

Preparation of LaryButton

Choosing correct size

• Diameter: To achieve an airtight fit and good retention the diameter of the Retention Collar of the LaryButton should exceed the diameter of the tracheostoma entrance. This is especially important for hands-free speech. Measure the size of the tracheostoma (largest diameter) with a ruler and fit the Provox LaryButton accordingly. In irregularly shaped tracheostomas, it may be difficult to achieve an airtight fit. Selection of a too small diameter will lead to a too loose fit; the device may fall out or air may escape when speaking. Selection of a too wide LaryButton may irritate or damage the tracheostoma.
• Length: In most cases the shorter size where the Retention Collar of the Provox LaryButton fits right behind the edge of the tracheostoma will provide a correct fit. However if the device is too short it may fall out of the tracheostoma. To help to choose what size(s) of LaryButton to prescribe to the patient, the clinician can use a Provox LaryButton Sizer Kit. The Sizer Kit contains samples (“sizers”) of commercially available Provox LaryButtons.

CAUTION: During fitting always make sure that the LaryButton does not reach the tracheal flange of the voice prosthesis. Optimal fit and performance of the Provox LaryButton is achieved if the patient has a so-called “tracheostoma lip” that is situated uniformly around the tracheostoma.

Preparing Atos LaryButton for insertion

• Before first use check that you have the correct size and that the package is not damaged or opened. Do not use otherwise.
• Make sure that your hands are thoroughly clean and dry before placing them in the area of the stoma or handling the Provox LaryButton and/or accessories.
• Have a mirror and sufficient light to illuminate the stoma.
• Always carefully inspect the Provox LaryButton before each use (i.e. before insertion), and ensure that it is undamaged and shows no signs of tears, cracks, or crusts. If you detect any damage, do not use the product, and obtain a replacement.
• Before insertion, rinse the device with drinking water to remove any disinfectant residues.
• Make sure that you only insert clean devices. In a hospital setting it is better to use sterile water rather than drinking water.
• If needed, lightly lubricate the Retention Collar of the device with some water-soluble lubricant. The following water-solublelubricants are recommended for use with the Provox LaryButton:
• KY Jelly
• SurgiLube
• Xylocaine /(lidocaine)

CAUTION: Only use water-soluble lubricants. Oil-based lubricants (e.g., Vaseline) may weaken damage or destroy the product and should not be used at any time.Make sure that you do not lubricate the HME Holder, HME Cassette or any accessory which is to be held by the Provox LaryButton, as this may lead to accidental detachment.

Inserting Provox LaryButton

There are 2 ways for insertion of LaryPage:
Procedure 1:

1. Fold the Retention Collar with your fingers and hold it firmly folded.
2. Insert the Retention Collar into the stoma and release it

Procedure 2:

• Fold the Retention Collar with your fingers
• Use a pair of blunt forceps or a lockable blunt hemostat from the inside o keep it folded CAUTION: DO NOT push the tip of the hemostats or forceps through the Provox LaryButton If the instrument tip is protruding from the button during insertion, the tissue of the trachea could be harmed and/or the voice prosthesis could ecome dislodged and subsequently be aspirated or ingested
• Insert the Retention Collar into the stoma
• Release the forceps to unfold the button

Check the correct fit by slightly pulling and/or rotating the button. Gently insert the Provox HME System component into the HME Holder.
NOTE: Some patients might experience more coughing after inserting the LaryButton and when touching the device to speak. This usually diminishes when the user gets used to the device. If discomfort occurs the LaryButton should be removed.

How to remove Atos Medical LaryPage

1. Hold the Provox LaryButton in place and gently remove the Provox HME System component from the HME Holder
2. Grasp the Provox LaryButton and gently turn it (about half a turn) to allow the Retention Collar to collapse thereby reducing its width
3. Remove the device by gently tilting it out of the stoma Alternatively, the device can be removed by pushing with a finger on the shaft from one direction and tilt the device out

NOTE: The insertion or removal procedures may occasionally cause some slight bleeding, irritation or coughing. Inform your clinician if the bleeding persists.

Cleaning and disinfection
CAUTION:

• Always remove the device from the stoma before cleaning.
• Do not at any time attempt to clean the device while inside the stoma since this could cause injury.
• Clean the Provox LaryButton after each use, or at least daily with the Provox TubeBrush.
• Do not use any water other than drinking water to clean and rinse the device.
• Be careful not to burn your finger in the warm cleaning water. Disinfect the Provox LaryButton at least once a day. with one of the following methods:
• • Ethanol 70% for 10 minutes
  • Isopropylalcohol 70% for 10 minutes
  • Hydrogenperoxide 3% for 60 minutes
• Do not use the device until it is completely dry. Inhalation of disinfectant fumes can cause severe coughing and irritation of the airways.
• If the Provox LaryButton looks dirty or has air dried in an area with a risk of contamination the device should be both cleaned and disinfected before use. A risk of contamination could exist if the device has been dropped on the floor or if it has been in contact with a pet, someone with a respiratory infection, or any other gross contamination.
• During hospitalization it is important to both clean and disinfect the Provox LaryButton after use but also before use since there is an increased risk of infection and contamination. In a hospital it is better to use sterile water for cleaning and rinsing, rather than drinking water.
• Do not clean or disinfect by any other method than described above as this might cause product damage and patient injury.

Storage instructions

• When not in use, clean and disinfect the device as described above and then store the Provox LaryButton in a clean and dry container at room temperature. Protect from direct sunlight.

Device lifetime

• The Provox LaryButton may be used for a maximum period of 6 months. If the device shows any signs of damage it shall be replaced earlier.


Disposal

• Always follow medical practice and national requirements regarding biohazard when disposing of a used medical device.


Contraindications

• Provox LaryButton is not intended to be used by patients that:
  • are under any form of mechanical ventilation.
  • have damaged tracheostoma tissue.