Introduction / Purpose

AVACEN is a noninvasive, drug-free, over-the-counter (OTC) heat therapy system designed to provide temporary relief for minor musculoskeletal discomfort.

Indications include:

1. Temporary relief of minor muscle pain, joint pain, and stiffness

2. Temporary relief of joint pain associated with arthritis, muscle spasms, and minor strains and sprains

3. Muscular relaxation

4. Temporary increase of local circulation where applied

The device is FDA 510(k) cleared for these indications.

Treatment Overview / How It Works

• AVACEN delivers gentle heat therapy through a user-friendly applicator, typically worn over the hand or targeted area

• Each session lasts 20–30 minutes

• Frequency of use may vary based on patient needs and provider recommendation

• Noninvasive and suitable for home or clinic use

Contraindications & Warnings

Do not use AVACEN if you have:

• Open wounds or skin lesions at the treatment site

• Severe peripheral vascular disease or compromised circulation

• Known hypersensitivity to heat therapy

• Implanted electronic devices (e.g., pacemakers), unless approved by your physician

• Pregnancy or breastfeeding (unless approved by your provider)

Use caution in patients with diabetes, neuropathy, or reduced heat sensation to avoid burns or skin injury.

Possible Risks / Side Effects

• Mild warmth or redness at the treatment site

• Temporary skin irritation or discomfort

• Rare: minor burns if misused or used on highly sensitive skin

Pre-Treatment Instructions

• Ensure the treatment area is clean and free of lotions, oils, or jewelry

• Inform the provider of any underlying medical conditions or medications

• Avoid prolonged exposure beyond recommended session duration

During Treatment / Application

• Patient remains seated comfortably with the device applied to the target area

• Patient should notify provider immediately if experiencing discomfort, overheating, or skin irritation

• Device settings should remain within recommended guidelines

Post-Treatment / Aftercare

• Remove device and allow the area to cool naturally

• Avoid applying additional heat sources to the area for at least 1–2 hours

• Maintain hydration and follow any provider-specific recommendations

• Schedule follow-up sessions as recommended

Patient Responsibilities

• Follow pre- and post-treatment instructions

• Report any adverse reactions immediately

• Adhere to recommended session duration and frequency

Acknowledgment & Consent

I acknowledge that:

• I have read and understood this consent form

• I understand the benefits, risks, and alternatives of AVACEN therapy

• I consent to the procedure and accept responsibility for my safety

• I release AI Wellness Center of Excellence, its staff, and affiliates from any liability except in cases of gross negligence or willful misconduct

I consent to photos or video for educational or promotional purposes, if applicable