08 Transducer design Flashcards
What is the V-model in Medical device development process?
Its a model that emphasises validation and verification processes throughout the design development process
What are “user requirements”?
High level requirements from the user perspective
(What the end user needs from the device)
What are the “design input requirements”?
Design input requirements are the documented technical requirements derived from user requirements and system environments
(Translates user requirements into measurable and technical specifications)
What is “Conceptual design”?
The identification of the system functions and a conceptual solution for each function
(Defines overall system architecture and outlines how the device will meet design inputs)
What is “detailed design”?
The implementation of the conceptual solutions with specified deimensions, materials, software etc.
What is “design VERIFICATION”?
Design verification is the process of checking that a product, system, or component meets specified (design) requirements and functions correctly, ensuring that the design is implemented as intended.
Answers the question of whether the product was built right.
What is “design VALIDATION”?
Design validation is the process of evaluating a product or system to ensure it meets the intended use and requirements (original user requirements).
Does it work in real world conditions (what it was actually meant for)
How do design verification and design validation differ?
Design verification ensures that the product meets specified requirements and is built correctly, while design validation ensures that the product fulfills its intended purpose and meets user needs.
What is a DACS device?
(D)irect (A)coustic (C)ochlear (S)timulator device
The implantable actuator (attached to the cochlea or near it) directly delivers mechnical vibrations to the cochlea, bypassing the damaged or impaired middle ear
The actuator converts electrical signals into the mechanical vibrations
Which hearing loss would benefit from DACS devices?
Individuals with mixed hearing loss
Specifically conductive hearing loss with
What is the limitation of DACS?
Non- measurable bone conduction level
What is the DACS implantation concept? (Stapes)
The physiological stapes is removed before being replaced by a prosthetic stapes
What are the important considerations when implanting things in the ear?
- Biocompatibility
(toxic material contact with tissue must be prevented, long term biocompatibility) - Size and geometry must bd considered (limited space to place an implant without causing any damage)
How is the middle ear transfer function determined?
The velocity of the stapes is measured for a constant sound pressure of 1 Pa (94 dB SPL) in front of the tympanic membrane
What is being mimicked in the DACS actuator concept development?
Conceptual designs of stapes replacements are being made to mimic physiological velocity spectrums
