SafeSplint

Description

SafeSplint is an inflatable upper extremity splint for immobilizing the hand in the correct safe anatomical position while providing rigid immobilization of a hand, wrist or forearm injury or fracture. It is a disposable, single use bladder system that inflates through three inlet ports around a patient's upper extremity to immobilize and splint the hand, assembled and applied by a physician, and adjusted (pneumatically or mechanically) by the patient. Each package contains one (1) 16" inflatable short arm splint, one (1) 16" stockinette, one (1) manual inflation pump, one (1) instructions for use document, and one (1) patient card for device identification. Apply SafeSplint at the time of upper extremity injury prior to obtaining professional orthopedic attention. Comfortably inflate SafeSplint to fit to the patient hand in a safe anatomical position while rigidly immobilizing the fracture for patient comfort for up to fourteen (14) days. Product is waterproof and sweat wicking. Remove and reapply the splint by the physician when necessary, and adjust air pressure by patient for comfort. Not intended to replace any casts (plaster or fiberglass), be used as an alternative to orthopedic intervention, set (reduce) the fracture, or hold a fracture that's already been set (reduced). Disclaimer regarding irritation: Physicians should assess patients for adverse reactions on the skin where the device has contact, such as redness (erythema), swelling (edema), irritation, sensitization (delayed Type IV hypersensitivity), allergy, immune response, or other reactions. Physicians may use a generic stockinette with SafeSplint to proactively prevent potential irritation. SafeSplint is not intended to be used on broken skin and wounds should be treated/covered as per standard of care prior to putting the SafeSplint on.