Description

Accel-Heal Solo is an innovative, single-use medical device designed to enhance the healing process of chronic and painful wounds through advanced electrical stimulation therapy. This discreet, wearable device is engineered to deliver a continuous 12-day treatment cycle, providing sub-sensory pulsed microcurrent therapy that complements standard wound care practices.

Key Features

• Wearable and Discreet: With dimensions of approximately 7cm x 4cm x 2cm, Accel-Heal Solo can be easily secured using a clip, strap, bandage, or stocking, making it suitable for use in various settings, including clinical, community, and home environments.

• Automated Therapy: The device operates with minimal intervention, requiring only the connection of hydrogel-based electrode pads to healthy skin near the wound. Once activated, it runs a pre-set program, with most patients not perceiving the electrical pulses due to their sub-sensory nature.

• Convenient Features: Includes LED indicators for operational feedback, a pause function for therapy interruption, and automatic voltage adjustment to ensure effective current delivery.

Usage and Management

The device is activated by a simple button press and automatically completes its therapy sequence, making it manageable by patients, carers, or healthcare professionals. It is designed to remain dry, with the capability to detach from wires during showering.

Clinical Benefits

Clinical evidence supports Accel-Heal Solo's effectiveness in promoting wound healing and alleviating pain, potentially reducing the need for pharmacological pain relief. Significant improvements in pain scores and wound healing rates have been reported, making it a valuable adjunct in wound management.

Safety Considerations

Accel-Heal Solo is not suitable for individuals under 18 or those with specific medical conditions such as active cancer, certain heart conditions, or epilepsy. It should not be used near varicose veins, main arteries, or in hyperbaric chambers. Users are advised to consult healthcare providers if necessary, and to be aware of potential allergic reactions to the hydrogel pads.

Environmental and Technical Specifications

The device should be stored between 5°C and 40°C with humidity levels of 10% to 80%. It is designed to function in environments with controlled electromagnetic interference and complies with relevant electrical safety standards.

Regulatory Compliance

Accel-Heal Solo is a Class IIa medical device, CE marked, and manufactured in accordance with ISO 13485:2016 standards. It adheres to the WEEE Directive for disposal, requiring return to a healthcare provider or appropriate facility after use.

Availability

This device is not available in the USA or South Africa, and it is intended to be part of a comprehensive wound care plan, enhancing healing rather than providing immediate wound closure.