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Lecture_01_Introduction to Biomedical Instrumentation

Biomedical

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5 views

Lecture_01_Introduction to Biomedical Instrumentation

Biomedical

Uploaded by

batool.fattah9
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Medical Instrumentation II

EENG574

2022-2023
Outlines
1- Introduction to Biomedical Instruments
2- Electrical Safety
3- Instruments for Surgery
4- Cardiac Defibrillators
5- Oximeters
6- Laser and its Applications
7- Incubators
8- Anesthesia Machine
9- Endoscopes
10- Lithotripters
11- Autoclave
Introduction to
Biomedical Instruments
Basic Model of Instrumentation Systems

“Biomedical instruments” refer to a very broad class


of devices and systems.
A biomedical instrument is an ECG machine to many people.
To others, it’s a chemical biosensor, and to some it’s a
medical imaging system.

Current estimates place the worldwide market for


biomedical instruments at over $200 billion.

Biomedical instruments are ubiquitous; they are vital to


many medical and scientific fields.

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Basic Model of Instrumentation Systems

Even though there is a wide variety of instruments, almost


all of them can be modeled using the simple diagram below

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Basic Model of Instrumentation Systems

Sensors and Actuators

A sensor must:

- detect biochemical, bioelectrical, or biophysical parameters


- reproduce the physiologic time response of these parameters
- provide a safe interface with biological materials

An actuator must:

- deliver external agents via direct or indirect contact


- control biochemical, bioelectrical, or biophysical parameters
- provide a safe interface with biologic materials

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Basic Model of Instrumentation Systems

Electronics Interface

The electronics interface must:

- match the electrical characteristics of the sensor/actuator


with the computation unit
- preserve signal-to-noise ratio (SNR) of sensor
- provide a safe interface with the sensor/actuator
- provide secondary signal processing functions for the
system

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Basic Model of Instrumentation Systems

Computation Unit

The computation unit must:

- provide primary user interface


- provide primary control for the overall system
- provide data storage for the system
- provide primary signal processing functions for the system
- maintain safe operation of the overall system

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Types of Biomedical Instrumentation Systems
Direct/Indirect:
The sensing system measure a physiologic parameter
directly, such as the average volume blood flow in an artery,
or measures a parameter related to the physiologic
parameter of interest (e.g., Organ morphology can be
determined from x-ray shadows)

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Types of Biomedical Instrumentation Systems
Invasive/Noninvasive
Direct electrical recording of the action potential in nerve
fibers using an implantable electrode system is an example
of an invasive sensor. An imaging system measuring blood
flow dynamics in an artery (e.g., ultrasound color flow
imaging of the carotid artery) is an example of a non-
invasive sensor.

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Types of Biomedical Instrumentation Systems
Contact/Remote

A strain gauge sensor attached to a muscle fiber can record


deformations and forces in the muscle. An MRI or
ultrasound imaging system can measure internal
deformations without contacting the tissue.

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Types of Biomedical Instrumentation Systems
Sense/Actuate
A sensor detects biochemical, bioelectrical, or biophysical
parameters. An actuator delivers external agents via direct
or indirect contact and/or controls biochemical,
bioelectrical, or biophysical parameters. An automated
insulin delivery pump is an example of a direct, contact
actuator. Noninvasive surgery with high intensity, focused
ultrasound (HIFU) is an example of a remote, noninvasive
actuator.

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Top Global Medical Device Companies

1- Johnson & Johnson (25.1 B$)

- Surgical Equipments (laparoscopy, ESU…)


- Orthopedic implants (joint, spine…)
- Diagnostic and therapeutic catheters
- Sterilization instruments
- Disinfection and hand hygiene products
- Skin adhesives
- Surgical sutures
- Breast implants

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CRICOS: 00116K
Top Global Medical Device Companies

2- Medtronic (20.2 B$)

- Cardiac pacemakers
- Infusion pumps
- Insulin pumps
- ESU
- Defibrillators
- Catheters and stents
- Heart valves
- Capsule endoscopy
- Oximeters
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CRICOS: 00116K
Top Global Medical Device Companies

3- GE Healthcare (17.6 B$)

- ECG
- Infusion pumps
- CT scanners
- MRI
- Ultrasound systems
- Incubators
- Warmers
- Fetal monitoring systems
- Ventilators
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CRICOS: 00116K
Top Global Medical Device Companies

4- Siemens Healthcare (14.5 B$)

- CT scanners
- MRI
- Ultrasound systems
- Laboratory Diagnostics chemistry systems
- Hematology systems

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CRICOS: 00116K
Top Global Medical Device Companies

5- Philips Healthcare (11.9 B$)

- Ventilators
- Drug delivery systems
- Oximeters
- X-ray machines
- CT scanners
- MRI
- ECG
- Defibrillators
- Monitors
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CRICOS: 00116K
QMS: a quality management system is a set of policies, processes and procedures
required for planning and execution (production/development) in the core business

Quality System (QS) area of an organization (i.e. areas that can impact the organization ability to meet
customer requirements).

Medical device manufacturers around the world are


regulated to ensure that their product conformity is
safeguarded.
Manufacturers are required to not only establish
specifications for their products and processes, but also to
put quality systems in place to ensure those requirements
are met.
They are also responsible to ensure they have the objective
evidence of meeting quality system (QS) requirements.

The two primary guidelines for medical device manufacturer


QMS and related services today are the ISO 13485 standards
and the US FDA 21 CFR 820 regulations.
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Food and Drug Administration (FDA)

The Food and Drug Administration (FDA or USFDA) is a


federal agency of the United States Department of Health
and Human Services.
The FDA is responsible for protecting and promoting public
health through the control and supervision of
- food safety,
- tobacco products,
- pharmaceutical drugs (medications),
- vaccines,
- blood transfusions,
- medical devices,
- electromagnetic radiation emitting devices (ERED)…

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CRICOS: 00116K
International Organization for Standardization (ISO)

The International Organization Standardization (ISO) is an


independent, non-governmental international organization.

International Standards, published by ISO, covers almost


every industry, from technology, to food safety, to
agriculture and healthcare systems.

International Standards give world-class specifications for


products, services and systems, to ensure quality, safety and
efficiency.

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CRICOS: 00116K
FDA or ISO?

Conducting an investigation according to both tenets should


result in the highest integrity device trial that affords the
most stringent level of protection for human research
subjects.

While this may be challenging, it can be accomplished with


hard work and proper preparation.

Ensuring trials comply with both sets of standards allows


companies that conduct international trials to feel confident
that the resulting data is acceptable not only in the US, but
also to worldwide regulatory agencies.

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CRICOS: 00116K

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