Dextreme™ Intended Use & Indications

Intended use

Dextreme is a robotic arm system engaged in the upper limb to assist patient rehabilitation from strokes, traumatic brain injuries (TBI), and other neurological disorders based on Error Augmentation technology. The Dextreme system rehab motor tasks are implemented in 3D VR games through the system computer monitor to motivate the practice. The system integrates biofeedback 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 with one of the following:

• Pregnant or nursing women.
• Acute orthopedic condition in the practicing limb.

Warnings and precautions

• Patients with active orthopedic upper-body injuries, acute trauma, fractures, or recent soft-tissue injuries in the practicing limb must consult a physician prior to initiating treatment.
• Similar to conventional physical exercise involving muscle exertion, patients may experience transient fatigue, minor muscle spasms, or muscle soreness during or after a session. These effects are anticipated, expected to resolve shortly after therapy, and should be reported to the supervising clinician if they persist.
• The Dextreme system is non-MRI compatible and must not be operated within a Magnetic Resonance Imaging (MRI) suite.
• System installation, technical maintenance, and structural updates must be executed solely by authorized Bioxtreme personnel. The device is designed to interface safely and exclusively with secure, official healthcare facility inner networks.

Regulatory status

Dextreme™ 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.

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