Plaxtreme Intended Use & Indications
Regulatory and safety information for the Plaxtreme hand and forearm rehabilitation device. Always follow the official product labeling, instructions for use and technical documentation supplied with the device.
Intended use
Plaxtreme is an electric powered robotic palm system intended to assist patient rehabilitation from strokes, traumatic brain injuries (TBI), and other neurological disorders, based on Error Augmentation technology. The Plaxtreme utilized motor tasks implemented in 3D VR games through the system computer monitor, to motivate practice. The system integrates biofeedback by using precise muscle strength measurements, range of motion, and other clinical scales to calculate and apply forces accurately across the entire motion cycle.
Contraindications
- The use of the system is prohibited for patients who have difficulty understanding the instructions for use.
- Cognitive impairment: patients with severe cognitive impairments may not be able to understand or follow the instructions for safe use of the device, which could result in improper use and potential injury.
Warnings and precautions
- Patients presenting with acute orthopedic upper-body injuries, trauma, fractures, or recent soft-tissue injuries in the practicing arm or hand must consult a physician prior to initiating treatment.
- The Plaxtreme system is non-MRI compatible and must not be operated within a Magnetic Resonance Imaging (MRI) suite. Additionally, operation is strictly prohibited within oxygen-enriched clinic areas.
- System installation, technical maintenance, and hardware or software modifications must be executed solely by authorized Bioxtreme personnel.
Regulatory status
Plaxtreme is FDA listed and CE-Marked. Approvals, registrations, certifications, features and labeling may differ by jurisdiction, and a reference to the product here does not mean it is available, approved, registered, certified or appropriate for use in your location or for your intended use.
