Össur PROPRIO FOOT W Instructions For Use Manual

Contents

4ENGLISHThe Unity® System is referred to as the device in the following document. This document provides importantinformation on the indications for use, and handling of the device. It is intended for a certified prosthetist and theuser of the device. The device may only be fitted by a qualified practitioner authorized by Össur after completingthe corresponding training.UNITY® SYSTEM COMPONENTS (FIGURE 2)1. Membrane bolt2. Mounting piece3. Anchor blade4. Bumper5. Spring blade6. Membrane7. Membrane housing8. Bumper bolt9. Duckbill10. Inlet port - tube fitting11. O-ring12. Inlet port - port fitting13. Attachment piece14. Attachment bolt15. Tube16. Outlet portPROPRIO FOOT®Refer to the PROPRIO FOOT® Information For Use.DEVICE DESCRIPTIONThe device is a prosthetic interface with suspension properties designed to provide elevated vacuum for socketsuspension. Expected attainable vacuum achieved during normal operation ranges from 15–18 inHg or higher.Assisted suspension is obtained through a pump which draws air out from the socket in each step creating anelevated vacuum inside the socket interface.The device is designed to function in any temperature and humidity that the user encounters during normal use.INDICATIONS FOR USEMajor lower limb amputations.CONTRAINDICATIONSNone known.INTENDED USEThe device is a non-invasive, reusable prosthetic device, designed for single patient use.The device should only be used with a prescription from a physician that includes the necessary treatmentinformation.N.B. The device is designed to be used with Iceross Seal-In® liners, other applications are the sole responsibility ofthe provider.SAFETYWarningThe device is weatherproof, therefore cannot be submerged in water (see Weatherproof section).