Instructions for Use

WBI LightWire — Oral Myofunctional Training Device

Manufacturer: WB Integrated Health International Private Limited Plot Number 337 Industrial Area Phase II, Chandigarh 160002 India

Contact: admin@wbihi.com · +91 9915222551 · WBIHI.com

Critical Safety Warnings

• DO NOT ALTER: Do not bend, twist, or manipulate the wire or structure of the appliance out of its prescribed shape. Unauthorized alteration can cause improper force distribution, device failure, or injury.
• INTERMITTENT USE ONLY: This device is not a permanent or continuous wear fixture. It must be removed throughout the day according to your therapist's schedule.
• DO NOT WEAR WHILE EATING: Always remove the appliance before eating, drinking hot liquids, or chewing. Wearing the device during mastication poses a choking hazard and will damage the appliance.
• DO NOT WEAR DURING SPORTS, SWIMMING, OR VIGOROUS ACTIVITY: Always remove the device before any intense activity or sport where the jaw or tongue may be difficult to control or be impacted, and before entering water.
• CHOKING HAZARD: Inspect the device before every use for loose parts, cracks, or structural damage. Do not place a damaged device in the mouth.

1. Device Description & Principle of Operation

The WBI LightWire is a non-powered, removable oral medical device designed for physiotherapy applications. It is engineered strictly and exclusively for tongue posture training as part of oral myology physiotherapy. The device works by providing a physical/proprioceptive feedback to train and condition the tongue muscles into the correct anatomical resting position.

2. Intended Purpose & Indications for Use

• Intended Purpose: To exercise and condition the tongue muscles to promote correct tongue posture.
• Indications for Use: For use in oral myology physiotherapy
• Target Patient Population: For adults undergoing oral posture / myofunctional training
• Intended Users: To be used by the patient as a part of myofunctional training and exercise

3. Contraindications

Do not use this device if you have:

• Inability to independently insert and remove the device safely without supervision (unless under constant caregiver assistance).
• Known allergies or hypersensitivities to Cobalt, Chromium, Nickel, Acrylic, or Stainless Steel.
• Periodontal disease, mobility of teeth, or unhealed oral wounds/ulcerations.

4. Instructions for Use & Handling

4.1 Insertion

1. Thoroughly brush your teeth and rinse your mouth before inserting the appliance.
2. Clean the appliance according to the instructions in Section 5.1.
3. Gently place the appliance into the mouth over the designated dental arch using your fingers.
4. DO NOT bite the appliance into place, as this may distort or break the device.

4.2 Wear Schedule

• Wear the device only for the durations prescribed by your myofunctional therapist or healthcare provider.
• Ensure the device is removed intermittently throughout the day as instructed.

4.3 Removal

1. Using your fingers, carefully disengage the retention mechanisms from your teeth.
2. Remove the appliance straight out of your mouth.
3. Immediately rinse the device under cool or lukewarm tap water.

5. Cleaning and Storage

5.1 Cleaning

• Daily Clean: After every removal, rinse the appliance with cool or lukewarm water. Brush gently using a soft-bristled toothbrush and mild, non-abrasive soap.
• Do Not Use: Avoid boiling water, hot water, harsh chemicals, bleach, or abrasive toothpastes, as these will warp or degrade the appliance materials.

5.2 Storage

• When not actively wearing the appliance, it must be stored inside the provided protective carry case.
• The appliance can be stored with or without the dental model.
• Ensure the appliance is dry before closing the case to prevent microbial growth.
• Keep the carry case away from direct sunlight, high heat sources, pets, and children.

6. Emergency & Adverse Incident Protocols

6.1 Pain, Stress, or Discomfort

If you experience any level of physical stress, pain, bleeding, mucosal ulceration, or severe difficulty while wearing the appliance:

1. Remove the appliance immediately.
2. Contact WBIHI support immediately at admin@wbihi.com for guidance. Do not attempt to reinsert the device until instructed.

6.2 Emergencies and Trapped Devices

• If the device appears stuck, unremovable, or if you experience severe respiratory or physiological distress while the device is removed or in place: 1. Seek immediate medical attention by contacting your local emergency services (e.g., 911) or visiting the nearest hospital emergency room. 2. Once you are safe and stable, contact WBIHI to report the incident.

6.3 Regulatory Serious Incident Reporting (EU MDR / Health Canada / CDSCO)

If any serious incident occurs in relation to the device (e.g., death, temporary or permanent serious deterioration of health), the user must report it to WBIHI and the Competent Authority of the country in which the user is established.

7. Lifetime, Maintenance, and Disposal

• Expected Service Life: Five (5) Years under normal usage conditions.
• Disposal: This device does not pose a biohazard unless contaminated with infectious biological material. Dispose of the appliance and carry case in accordance with local environmental regulations and municipal solid waste guidelines.

8. Administrative & Regulatory Information

• Document Revision: IFU-WBI-001
• Date of Issue: July 2026
• Manufacturer Registration No. (CDSCO): WBINT-Ahmed-GJ/M/MD/030168

9. Glossary of Symbols