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This document specifies a data-centric personalized surveillance framework for the continuous monitoring on use and care of artificial eye (ocular prostheses) for individuals with eye loss or visual impairment. The framework focuses on the structured collection, integration, and use of diverse prosthesis-related data—including wear patterns, hygiene records, socket condition, user-reported outcomes, and relevant health information associated with artificial eye usage. It defines requirements for data-driven hygiene tracking, adverse event reporting, and continuity of care across both clinical and home settings. The document also provides guidance for users, caregivers, and service providers to utilize this data to ensure safe, effective, and inclusive management of artificial eyes—not only throughout the device lifecycle but also across the wearer’s lifetime using usecase examples.
Reģistrācijas numurs (WIID)
85419
Darbības sfēra
This document specifies a data-centric personalized surveillance framework for the continuous monitoring on use and care of artificial eye (ocular prostheses) for individuals with eye loss or visual impairment. The framework focuses on the structured collection, integration, and use of diverse prosthesis-related data—including wear patterns, hygiene records, socket condition, user-reported outcomes, and relevant health information associated with artificial eye usage. It defines requirements for data-driven hygiene tracking, adverse event reporting, and continuity of care across both clinical and home settings. The document also provides guidance for users, caregivers, and service providers to utilize this data to ensure safe, effective, and inclusive management of artificial eyes—not only throughout the device lifecycle but also across the wearer’s lifetime using usecase examples.
