Architecture
The document discusses active implantable medical devices (AIMDs) and their design. It begins with an overview of AIMDs,
Design
noting they are medical devices implanted surgically to power sensors and actuators. The cochlear implant is used as an
example to discuss how AIMDs can restore lost sensory functions. It describes the auditory system and how cochlear implants
work as a sensory prosthesis. The document outlines how microelectronics can improve AIMD performance by reviewing the
AIMD system architecture, interfaces like electrode arrays and implantable sensors, and components like batteries and
processing units. It concludes by discussing modeling tools
Adopting level set theory based algorithms to segment human earIJCI JOURNAL
Human identification has always been a topic that interested researchers around the world. Biometric methods are found to be more effective and much easier for the users than the traditional identification methods like keys, smart cards and passwords. Unlike with the traditional methods, with biometric methods the data acquisition is most of the times passive, which means the users do not take active part in data acquisition. Data acquisition can be performed using cameras, scanners or sensors. Human physiological biometrics such as face, eye and ear are good candidates for uniquely identifying an individual. However, human ear scores over face and eye because of certain advantages it has over face. The most challenging phase in human identification based on ear biometric is the segmentation of the ear image from the captured image which may contain many unwanted details. In this work, PDE based image processing techniques are used to segment out the ear image. Level Set Theory based image processing is employed to obtain the contour of the ear image. A few Level set algorithms are compared for their efficiency in segmenting test ear images
fNIRS and Brain Computer Interface for CommunicationInsideScientific
LIVE WEBINAR: June 8, 2017
Dr. Ujwal Chaudhary and Dr. Bettina Sorger present groundbreaking research in the field of fNIRS-based BCI for communication with healthy subjects and patients in completely locked-in states.
Neural activity is accompanied by a hemodynamic (vascular) responses that is sensitive to a host of features of coordinated brain function. Relating these measures to the seemingly endless breadth of human behavior is a principal aim of many scientific investigations. Fortunately, learning, language acquisition, sensory and motor functions, emotion, social interactions, and the influence of a host of disease processes can all be explored from measures of the functional near-infrared spectroscopy (fNIRS) signal. Wearable fNIRS technology exists that is portable, safe and easy to use, resistant to motion artifacts and can be employed in a subjects natural environment.
A promising application for fNIRS is the design of brain-computer interfaces (BCIs) for communication with completely locked-in patients. In the so called ‘locked-in’ state, fully conscious and awake patients are unable to communicate naturally due to severe motor paralysis. These patients are, however, able to modulate their brain activity which can be decoded and understood by exploring the fNIRS signal.
In this exclusive webinar sponsored by NIRx Medical Technologies, experts present the basic principles of fNIRS and BCI, technical setup and guidelines for running a successful fNIRS study and a comparison of fNIRS with other functional neuroimaging methods. Presenters highlight groundbreaking research in the field of fNIRS-based BCI for communication with healthy subjects and patients in a completely locked-in state. Specifically, Dr. Ujwal Chaudhary (University of Tübingen) shares results of his research with healthy participants and patients with locked-in syndrome due to amyotrophic lateral sclerosis (ALS). Dr. Bettina Sorger (Maastricht University) presents data from a recent study demonstrating the feasibility of a multiple-choice fNIRS-based communication BCI using differently-timed motor imagery as an information-encoding strategy.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
Adopting level set theory based algorithms to segment human earIJCI JOURNAL
Human identification has always been a topic that interested researchers around the world. Biometric methods are found to be more effective and much easier for the users than the traditional identification methods like keys, smart cards and passwords. Unlike with the traditional methods, with biometric methods the data acquisition is most of the times passive, which means the users do not take active part in data acquisition. Data acquisition can be performed using cameras, scanners or sensors. Human physiological biometrics such as face, eye and ear are good candidates for uniquely identifying an individual. However, human ear scores over face and eye because of certain advantages it has over face. The most challenging phase in human identification based on ear biometric is the segmentation of the ear image from the captured image which may contain many unwanted details. In this work, PDE based image processing techniques are used to segment out the ear image. Level Set Theory based image processing is employed to obtain the contour of the ear image. A few Level set algorithms are compared for their efficiency in segmenting test ear images
fNIRS and Brain Computer Interface for CommunicationInsideScientific
LIVE WEBINAR: June 8, 2017
Dr. Ujwal Chaudhary and Dr. Bettina Sorger present groundbreaking research in the field of fNIRS-based BCI for communication with healthy subjects and patients in completely locked-in states.
Neural activity is accompanied by a hemodynamic (vascular) responses that is sensitive to a host of features of coordinated brain function. Relating these measures to the seemingly endless breadth of human behavior is a principal aim of many scientific investigations. Fortunately, learning, language acquisition, sensory and motor functions, emotion, social interactions, and the influence of a host of disease processes can all be explored from measures of the functional near-infrared spectroscopy (fNIRS) signal. Wearable fNIRS technology exists that is portable, safe and easy to use, resistant to motion artifacts and can be employed in a subjects natural environment.
A promising application for fNIRS is the design of brain-computer interfaces (BCIs) for communication with completely locked-in patients. In the so called ‘locked-in’ state, fully conscious and awake patients are unable to communicate naturally due to severe motor paralysis. These patients are, however, able to modulate their brain activity which can be decoded and understood by exploring the fNIRS signal.
In this exclusive webinar sponsored by NIRx Medical Technologies, experts present the basic principles of fNIRS and BCI, technical setup and guidelines for running a successful fNIRS study and a comparison of fNIRS with other functional neuroimaging methods. Presenters highlight groundbreaking research in the field of fNIRS-based BCI for communication with healthy subjects and patients in a completely locked-in state. Specifically, Dr. Ujwal Chaudhary (University of Tübingen) shares results of his research with healthy participants and patients with locked-in syndrome due to amyotrophic lateral sclerosis (ALS). Dr. Bettina Sorger (Maastricht University) presents data from a recent study demonstrating the feasibility of a multiple-choice fNIRS-based communication BCI using differently-timed motor imagery as an information-encoding strategy.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
IT IS THE NEW SIDE OF LIFE SCIENCE WHICH CAN IMPROVE THE FUNCTIONALITY OF DAMAGE PART OF THE EYE , IN THIS PPT VARIOUS TECHNIQUES ARE DESCRIBED ON BIONIC EYE.
in this presentation we have worked in the theme of bio MEMS in the midical staffs specially in bionic eye
this technologie help blind peopls to get there vision back
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
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IT IS THE NEW SIDE OF LIFE SCIENCE WHICH CAN IMPROVE THE FUNCTIONALITY OF DAMAGE PART OF THE EYE , IN THIS PPT VARIOUS TECHNIQUES ARE DESCRIBED ON BIONIC EYE.
in this presentation we have worked in the theme of bio MEMS in the midical staffs specially in bionic eye
this technologie help blind peopls to get there vision back
thanks to Pr.brandly in 1960 how invented the first device which colled bionic eye
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
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Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Aimd same v09
1. Theory of operation
Architecture
Design
Active Implantable Medical Device Design :
The cochlear implant example
Nicolas Veau1
1 Neurelec, MXM group
SAME conference, October 6th , 2010
SAME2010 Active Implantable Medical Devices
2. Theory of operation
Architecture
Design
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
3. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
4. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
What is an Active Implantable Medical Device ?
Denition and examples
Medical Device: Maintain human physiological functions.
Implantable: Inserted into the human body by surgery.
Active: Uses energy to power its sensors and actuators.
Brain stimulators Heart stimulators
SAME2010 Active Implantable Medical Devices
5. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Economical environment
1 The AIMD is mainly used for :
Sensory and functional prosthesis for invalidating disabilities.
Automated drug delivery for chronicle diseases therapies.
Health monitoring and prevention.
Health care outsourcing.
2 The AIMD aims to :
Improve the quality of life by reducing disabilities, anxiety.
Extend the life time by monitoring vital signs.
Decrease the societal cost by improving the patient autonomy.
3 The AIMD market growth is driven by :
The rehabilitation of disability considered as a public priority.
The population aging.
The over weighted people growth.
The emergence of new geographic markets.
SAME2010 Active Implantable Medical Devices
6. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Economical environment
1 The AIMD is mainly used for :
Sensory and functional prosthesis for invalidating disabilities.
Automated drug delivery for chronicle diseases therapies.
Health monitoring and prevention.
Health care outsourcing.
2 The AIMD aims to :
Improve the quality of life by reducing disabilities, anxiety.
Extend the life time by monitoring vital signs.
Decrease the societal cost by improving the patient autonomy.
3 The AIMD market growth is driven by :
The rehabilitation of disability considered as a public priority.
The population aging.
The over weighted people growth.
The emergence of new geographic markets.
SAME2010 Active Implantable Medical Devices
7. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Economical environment
1 The AIMD is mainly used for :
Sensory and functional prosthesis for invalidating disabilities.
Automated drug delivery for chronicle diseases therapies.
Health monitoring and prevention.
Health care outsourcing.
2 The AIMD aims to :
Improve the quality of life by reducing disabilities, anxiety.
Extend the life time by monitoring vital signs.
Decrease the societal cost by improving the patient autonomy.
3 The AIMD market growth is driven by :
The rehabilitation of disability considered as a public priority.
The population aging.
The over weighted people growth.
The emergence of new geographic markets.
SAME2010 Active Implantable Medical Devices
8. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
9. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
The auditory system
How does the ear work ?
External Ear: Antenna amplier conduction line
Middle Ear: Impedance matching Automatic Gain Control
Inner Ear: Analog-to-Digital Converter
SAME2010 Active Implantable Medical Devices
10. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
The auditory system
How does the internal ear work ?
Basilar membrane: Transform pressure variation in membrane
displacement. Behave as an analog delay line.
Corti Organ: Sense the displacement pattern on the basilar
membrane.
[2]
SAME2010 Active Implantable Medical Devices
11. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
The auditory system
How does the inner ear work ?
Inner Hair Cell: Amplitude time-space sampler. Low frequency
detector.
Outer Hair Cell: Frequency and phase time-space sampler. Up to
16kHz detector.
[2] [3]
SAME2010 Active Implantable Medical Devices
12. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
The auditory system
Auditory pathway from the inner ear to the brain
Auditory pathways: Autocorrelators feedback loops
Cortex: Correlators and associative memory
[2]
SAME2010 Active Implantable Medical Devices
13. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
14. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Cochlear Implant
How does the cochlear implant work ?
External ear middle ear = Microphone DSP
Inner hair cell Outer hair cells = Electrode array
[1]
SAME2010 Active Implantable Medical Devices
15. Theory of operation Overview
Architecture The auditory system
Design The cochlear implant system
Cochlear Implant
Clinical needs and their impacts on the electronics requirements
1 Reliability
1 System reliability
2 Data transfer reliability
2 Clinical performance
1 Good signal processing for voice, music, noise environment
2 Better stimulation with higher temporal and spatial resolution
3 User friendly interface
4 Data fusion
3 Low invasiveness
1 Miniaturization
2 Maintenance surgery
3 Active time
SAME2010 Active Implantable Medical Devices
16. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
17. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
AIMD architecture
Physical view
Subsystems : Constraints :
Stimulation Connections
Sensors Encapsulation
Energy transfer/storage Manufacturing
Communications Agreements
SAME2010 Active Implantable Medical Devices
18. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
AIMD architecture
Functional view
SAME2010 Active Implantable Medical Devices
19. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
AIMD architecture
Data path view
SAME2010 Active Implantable Medical Devices
20. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
21. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Electrode array
Characteristics
Clinical targets :
Preserve neurons
Activate neurons on demand
Monitor neuron activity
Electrode array characteristics :
Mechanical control : toxicity, insertion trauma, infection
Precise current control : in amplitude, time, in space
Tissue impedance measurements
Electrode arrays
[4]
SAME2010 Active Implantable Medical Devices
22. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Electrode array
3D current control
Virtual electrodes : Allow current steering and focusing for higher
neuron selectivity.
Complex waveforms : Allow better neuron preservation and
ecient stimulations.
Virtual electrodes concept
[4]
SAME2010 Active Implantable Medical Devices
23. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Implantable sensors
The interface with the outside world
RAIC
Acoustic sensor Bio-signal sensor
t pic N1 : en
et
pic P1 : 70
entre 400
fRAIC compri
1 kHz et 1
Amplitude de
entre 20 µV et
courant de st
Low noise, low power Neural response
Automatic gain control. Neural synchrony
Helium-leak test compliant Stimulation loop back
Low prole, small volume Time variability oset
SAME2010 Active Implantable Medical Devices
24. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Radio communication
Trans-cutaneous communication interface
Usages: Remote control, tting, multimedia accessories
Description du canal de propagation:
Figures: Below 3mW in 64kbps DL. Below 1µ W in standby.
1Mbps max.
Dilemma: Antenna)
FA ( Inverted Energy/Data transfer, Magnetic/Electromagnetic
Peau Cartilage Graisse Equivalent
Epaisseur 1 mm 4 mm 34 mm 39 mm
on: Permittivité 38.01 38.77 5.28 9.55
relative r
Link budget Antenna réalisé 8.55 13.98
Modèle
Conductivité 44.25 52.63
sous HFSS
Facteur de 0.0226 0.0190 0.1170 0.07151
perte
Caractéristiques des 3 tissues du model équivalent à 2.45 GHz
http://niremf.ifac.cnr.it/tissprop/htmlclie
Antenne IFA dessinée sous HFSS
Loss between external ear and F=2.45GHz, BW=80MHz,
implant : - 25dB @ 2.45GHz Z =50Ω L 30.35 mm
in
l 0.5 mm
SAME2010 Active ImplantableHMedical Devices
2 mm
25. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
26. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Battery
Safety : Backup system, safe chemistry, hot swap,
EN45502-2-3.
Protection : Titanium casing with feed-through, over and
under charge, emergency stop.
Energy transfer : Capacity vs., charging time, charging time
after 10 years.
Inductive charging : EN45502-2-3, expected eciency above
70%
Energy distribution : 0.9 V.
SAME2010 Active Implantable Medical Devices
27. Theory of operation The AIMD system
Architecture The AIMD interfaces
Design The AIMD components
Processing units
1 Intensive processing routines : Physiological noise ltering,
artifact reduction, sensor data fusion, stimulations building,
signal features extractions ...
2 Processing units : ASIC, ASP, FPGA, DSP, DMA, MCU
3 Software architecture : Usually no RTOS, no vendors libraries
for safety reasons, specic development and test guidelines.
Generic datapath
SAME2010 Active Implantable Medical Devices
28. Theory of operation Modeling tools
Architecture Simulation tool
Design
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
29. Theory of operation Modeling tools
Architecture Simulation tool
Design
Analytical models
Multi-physics models
1 Captures tight physics interactions : acoustic, viscosity and
thermal combined eects.
2 Ecient for variable sensitivity analysis and optimization under
constraints.
3 Supported by simpler and easier to understand lumped
elements representations.
Subcutaneous microphone
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SAME2010 Active Implantable Medical Devices
30. Theory of operation Modeling tools
Architecture Simulation tool
Design
Analytical models
Statistical and biological models
1 The model computes the neurons population recruited by
electrical stimulation according to their ring rate.
2 This model is used to identify the virtual electrodes that
maximize spatial selectivity and directivity of a stimulation
Current focusing and steering
Current Focusing − Contour Plot of Number of Neurons Fired Current Focusing − Number of Neurons Fired Current Steering − Contour Plot of Number of Neurons Fired Current Steering − Number of Neurons Fired
2.5 90 100 2.5 90 100
σ=0 α=0
2 80 90 σ = 0.5 2 80 90 α = 0.25
σ = 0.75 α = 0.5
1.5 80 1.5 80
70 σ=1 70 α = 0.75
electrode α=1
1 70 1 70
60 60 electrode
Neurons Fired
Neurons Fired
0.5 60 0.5 60
Location (x)
Location (x)
50 50
0 50 0 50
40 40
−0.5 40 −0.5 40
30 30
−1 30 −1 30
−1.5 20 20 −1.5 20 20
−2 10 10 −2 10 10
−2.5 0 0 −2.5 0 0
0 0.2 0.4 0.6 0.8 1 −2.5 −2 −1.5 −1 −0.5 0 0.5 1 1.5 2 2.5 0 0.2 0.4 0.6 0.8 1 −2.5 −2 −1.5 −1 −0.5 0 0.5 1 1.5 2 2.5
σ values Location along Neural Clusters(x) α values Location along Neural Clusters(x)
SAME2010 Active Implantable Medical Devices
31. Theory of operation Modeling tools
Architecture Simulation tool
Design
Numerical models
Physics models
1 Useful for complex geometry and numerous interfaces
2 Reduce the number of prototypes and cost
3 Computations intensive, slow optimization convergence
4 Expensive tools, dicult to set them up, lack of
interoperability with others tools.
Antenna Magnetic systems Piezoelectric systems
SAME2010 Active Implantable Medical Devices
32. Theory of operation Modeling tools
Architecture Simulation tool
Design
Numerical models
Statistical and biological models
A simplistic 3D model of the cochlea
Accompanying electrode array
Generated potentials and currents through the cochlea when
the electrodes were stimulated.
Neural response to electrical stimulation was observed.
BEM and HodgkinHuxley model method
[6]
SAME2010 Active Implantable Medical Devices
33. Theory of operation Modeling tools
Architecture Simulation tool
Design
Outline
1 How can an AIMD restore lost human sensory functions ?
Overview
Sensory processing : The auditory system example
Sensory prosthesis : The cochlear implant example
2 How can microelectronics benet to AIMD's performances ?
The AIMD system
The AIMD interfaces
The AIMD components
3 How to solve strongly coupled constraints in an AIMD design ?
Modeling tools
Simulation tool
SAME2010 Active Implantable Medical Devices
34. Theory of operation Modeling tools
Architecture Simulation tool
Design
Cochlear implant simulator
SAME2010 Active Implantable Medical Devices
35. Bibliography I
[1] Digisonic SP system
http://neurelec.com/
NEURELEC, Vallauris
[2] Pujol R. al.
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SAME2010 Active Implantable Medical Devices