Scribd
Upload
6 views

Mak Lect 1 (1)

Uploaded by

anitangabire017
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
6 views

Mak Lect 1 (1)

Uploaded by

anitangabire017
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 42

Medical devices and instrumentation II

Clinical Engineering

Lecture 1

By
Matovu Brian
Objectives and Learning outcomes

Objectives
• To develop and design new models of medical devices
• To describe the structure and operations of medical equipment
• To demonstrate skills in maintenance, servicing, repair of medical
equipment
• To discuss quality control measures performed on various medical
devices.
Learning outcomes
• Appreciate the current designs and develop new designs of medical
devices
• Understand the working and operating principles of medical equipment
and devices
Course content
Introduction, examples, fundamental rules of bioinstrumentation, basic
instrument, types of sensors, Medical equipment symbols, calibration
and maintenance. Theory of operation, calibration and maintenance of
medical equipment.
 Medical imaging: Ultrasound, X-rays, Computerized tomography (CT
scanners), magnetic resonance imaging (MRI),
 Oxygen: Oxygen concentrators, Oxygen cylinders, Oxygen
generators, Bulk gas system, Administering oxygen, Flow meters and
regulators, Respiration therapy and ventilators, Mechanics of
ventilation
 Therapeutic & prosthetic devices: defibrillators, pacemakers,
bladder stimulators, electro surgery devices, ventilators, incubators,
etc.
Medical device
Instrumentation
Bioinstrumentation
Bioinstrumentation is an application of Biomedical engineering which focuses on the devices and
mechanics used to measure, evaluate and treat biological systems . Examples include: patient
monitors, defibrillators and glucose monitoring machine, clinical thermometer etc.
TYPICAL BIOMEDICAL
INSTRUMENT

Devices that can be used to make measurements of biological medical quantities and
give quantitative (or sometimes qualitative) results
FUNDAMENTAL RULES OF
BIOINSTRUMENTION

1. Minimum disturbance to physiologic


system
2. Sensor must be at physiologic variable
value
3. Maintain Simplicity
Types of Sensors

2. Chemical
1. Physical  Oxygen electrode
 Strain gauge  Glass electrode (pH)
 Accelerometer
 Load cell (force) 3. Bioanalytical
 Pressure sensor  Glucose sensor
 Lactate sensor. etc.
IMPORTANT TERMS IN
BIOINSTRUMENTATION`

 Sensitivity -Change in output as a function of a change in input

 Stability -Consistency in output for a constant input

 Specificity-Ability to distinguish desired variable from other competing variables

 Accuracy -Difference between true value and measured value divided by the true
value
 Precision -Number of distinguishable alternatives from which a given result is selected

 Resolution -Smallest increment that can be measured with certainty


 Reproducibility -Same output for the same input
Medical device Vs Medical Equipment

• Medical device: An instrument/apparatus / machine that is used in the prevention,


diagnosis or treatment of disease, or for detecting, measuring, restoring, correcting
or modifying the structure or function of the body for some health purpose.

• Medical equipment: Medical devices requiring calibration, maintenance, repair,


user training, and decommissioning activities usually managed by clinical engineers.
Medical equipment is used for the specific purposes of diagnosis and treatment of
disease or rehabilitation following disease or injury.
Medical equipment classification
1.Diagnostics Equipment: Any type of equipment whose main purpose is to help doctors detect and

diagnose diseases for example: ECG, EMG, EEG, Ultrasound machines, X-ray machines, CT Scanners, MRI

machines, Endoscopes

2. Therapeutic Equipment: Any equipment used after surgeries and other medical treatments to help

patients recover and improve their health. For example: Medical Lasers, Catheters, Endoscopes,

Radiotherapy machines, Ocular Equipment, Dental Equipment


3.Surgical Instruments: Any instrument can be used in surgeries for example: Cutting instruments, Grasping or holding

instruments.

4. Life support Equipment: Any equipment that is used to maintain a patient’s organs functioning when said organs

have failed For example: Hemodialysis, Ventilators, Incubators, Heart Lung Machine
5.Laboratory Equipment: Any equipment that is used in laboratories for example: sample separation, centrifugation
etc.
*electrophoresis, capillary *particle / cell counters
*spectrophotometers *flow cytometry
*microscopy
Classes of medical devices
There are 3 classes of medical
devices:
• Class I devices are low-risk devices.
Examples include bandages,
handheld surgical instruments, and
nonelectric wheelchairs.
• Class II devices are intermediate-
risk devices. ...
• Class III devices are high-risk
devices that are very important to
health or sustaining life.
Medical Equipment Symbols
CE Marking

• The CE mark indicates


conformity with EU
health, safety, and
environmental
protection standards on
many products that are
traded on the single
market in the European
Economic Area (EEA).
ATTENTION

• This indicates that attention must

be given before using the product.

• For example, it may lead on to

guidance that instructions are

included in the packaging and

must be read prior to use.

• In this case the attention symbol

will be accompanied by a symbol

of a book.
Keep Dry

• Indicates a medical
device that needs to
be protected from
moisture.
Product Expiry Date / Use By

• Product Expiry Date /


Use By – this symbol
will be next to the date
(year/ month) on
which a product must
be used by.
Date of Manufacture

• The white factory indicates


the date that the product
was manufactured.
Manufacturer

The black factory shows details


of the product manufacturer
and gives that address.
It is important to note the
difference between the two.
Single use symbol

• Single use symbol,


which means that
the medical device must
only be used once and
then disposed of in the
correct manner.
The product must
not be re
sterilized.
• This symbol indicates that
the medical device is
sterile, along with the
method by which it has
been sterilized – in this
specific case ethylene
oxide.
• Other medical product
sterilization methods can
include radiation (R), x-ray
(E) and hydrochloric acid
(H).
The product has not
been sterilized.
Do not use the
product if the box is
damaged.
Use of the “Rx only”
Rx only symbol as an
Caution: Federal law restricts this device
to sale by or on the order
alternative to the
prescription device
labeling statement.
• Three Phase alternating
current
• - To indicate the type of
mains supply
• Three Phase alternating
current with neutral
conductor
• To indicate the type of
mains supply
• Importer
• Indicates the entity importing
the medical device into the
locale.
Summary
Summary
• Bioinstrumentation

• Typical Biomedical instrument

• Rules of bioinstrumentation

• Sensors

• Medical Devices vs Medical Equipment

• Classes of medical devices

• Medical Equipment symbols


Certifications
Certifications
“In whatever you do, always give 100% unless you’re donating
blood.”
By Bill Murray

You might also like