03 TM Technical Topics

Technology Management:
Medical Equipment Design

and Electrical Safety
1 © ECRI Institute
Outline of Content
 Electrical Safety
 Equipment Protection Classifications
 Electrical Shock
2 © ECRI Institute
ELECTRICAL SAFETY
3 © ECRI Institute
Electrical Safety
 Medical electrical equipment is
categorised into several classes and
protection classifications.
Why?
Class - To inform equipment user on the method

(earthed or double-insulated) used to protect against
electrical shock.
Protection Classification – To inform equipment user on

the degree the equipment is designed to protect against
electrical shock.
4 © ECRI Institute
240V AC Mains Power
 Can be dangerous to patients and staff if you
accidentally touch the “Live” connection
 Mains power is “Earth” seeking
Off
On General
Earth
Purpose
Outlet
Neutral Live
5 © ECRI Institute
Essential Mains Power
 Different colour to regular power
 Suitable for critical equipment
 Generator backup
Off
On
Earth
Neutral Live
6 © ECRI Institute
UPS Mains Power
 Uninterruptible Power Supply – outlets are typically yellow
 Hospital generator provides backup power when normal 240 V AC
mains supply drops out
 Critical, life-support equipment should be connected to these
outlets
Off
On
Earth
Neutral Live
7 © ECRI Institute
240V AC Mains Power
 Is used to power medical electrical
equipment
 Via flexible insulated mains cord
Medical Equipment
Mains Part
Applied
Part
E
N
L
8 © ECRI Institute
240V AC Mains Power
 Insulated mains cord offers protection
 Avoid exposed inner wires
Medical Equipment
Mains Part
Applied
Part
E
N
L
9 © ECRI Institute
240V AC Mains Power
 Fluid spill into the equipment
 Can be dangerous
 Send to biomedical engineering for urgent
attention
Medical Equipment
Mains Part
Applied
Part
E
N
L
10 © ECRI Institute
Conductors and Insulators
Relatively good Relatively good
Conductors Insulators
Copper Human Plastic, Perfect

Wire Body Rubber Ceramic Vacuum
0.1 1 1000 1 million 10million 100 million
Ohms
Class I Medical Equipment
 Three pin power plug
 Uses the safety earth wire
Live (active)
wire
Earth wire
Fuse
Neutral wire
Cable grip
Source: GCSE Science/Safety in Mains circuits, WikiBooks
Class I Medical Equipment
 Equipment with protective earth (metal stub)
 Accessible metal parts are earthed to ensure
that if they become live at any stage, high
current will flow, blowing the equipment fuse
Earth Protective Equipotential

Earth Earth
Common symbols on the equipment

Source: On-site Photo
Class II Medical Equipment
Source: ECRI On-site Photo
 Double insulation (two layers of insulation)

 2-prong power plug (without earth wire)
 Usually a non-conductor exterior cover of the
equipment
 Two concentric square symbol printed on the
equipment
 Class 2: “Double Insulated”
Medical Equipment
Mains Part
Applied
Part
N
L
 Class 2: “Double Insulated”
◦ with an internal fault
Medical Equipment
Mains Part
Applied
Part
N
L
Class III Medical Equipment
 Not 240V mains powered
 Low Voltage
 Can be battery only operated equipment
17 © ECRI Institute Source: ECRI On-site Photo

EQUIPMENT
PROTECTION
CLASSIFICATIONS
Equipment Protection Classifications
 There are several protection classifications

of electrically operated medical equipment
 Why?
 Used at different areas and application thus have

different safety requirements
 To ensure adequate safety for patient and operator

 Electrical safety of medical equipment is critical
because:
◦ the nature of use – electrical connection to patient
◦ non responsive patient – could be receiving an
electrical shock but cannot speak or move
◦ environment – presence of conductive solutions
 e.g., saline and blood
 Therefore, medical equipment connected to
patients has to be electrically safe
 Protection classifications
• B (Body)
• BF (Body Floating)
• BF Defibrillator Proof
• CF (Cardiac Floating)
• CF Defibrillator Proof
Type B
 This equipment provides no particular degree
of protection
 B type can be found for some medical
equipment
 Body symbol printed on the equipment
 If no symbol, then we assume that the
equipment is B type
Type BF
 Similar to type B but with isolated or floating
(F-type) applied parts to isolate the patient
from faulty equipment
 Common BF type medical equipment:
• Physiologic Monitor
• Pulse Oximeter
 Body in a square box symbol printed on the
equipment
Type BF Defibrillation
Proof
 BF type equipment but this equipment is safe

to be used when defibrillation is applied
 Common medical equipment of this type are:
• NIBP
• Pulse Oximeter
 Body in a square box with defibrillator paddles

symbol printed on the equipment
Type CF
 Equipment providing a higher degree of
protection against electric shock than type BF,
particularly with regards to allowable leakage
currents, and having floating applied parts
 The heart is more sensitive to electrical

current
 This equipment can be used during cardiac

procedures such as with open heart surgery,
or while placing pacemaker wires in the heart
Type CF
 This is where an electrical
connection may come in
direct contact with the heart
 Common medical equipment of this types
are:
• ECG monitors
• Invasive Blood Pressure (IBP) monitors
 Heart in a square box symbol printed on

the equipment
Type CF Defibrillation Proof
 Similar to type CF but this
equipment is safe to be used
in a situation where
defibrillation is applied
 This device can remain connected to the

patient during defibrillation
 Common medical equipment of this type is:
• ECG devices, IBP monitors
 Heart in a square box with defibrillator
paddles symbol printed on the equipment
ELECTRICAL SHOCK
Electrical Shock
 There are 2 types of potential electrical
shocks:
• Macro Shock – Current that leaks from

medical equipment and passes through the
body because the mains current is
“Earth Seeking”
• Micro Shock – Current that leaks from
medical equipment that has direct electrical
connection to the heart
Macro Shock
 Mains power is “earth” seeking
 Macro shock depends on
• Voltage
• Resistance
Source: MDUT Training Material
 The significant component is the CURRENT

Macro Shock
 Leakage current occurs because no equipment
is made using perfect insulators
 The term ‘leakage’ current refers to current

not intended to be applied to the operator or
patient that flows from conductive portions of
the equipment back through the earth wire
 Electrical current in excess of 10 mA passing

through the skin and into the body
Macro Shock
 Mains Safety Switch - good for Macro
Shock protection
◦ Trips (off) during a problem/fault
Earth Leakage
Circuit Breaker
(ELCB)
Safety Switch
Source: Wikipedia
Micro Shock
 Imperceptible electrical current (more than 10 uA)
applied directly, or in very close proximity, to the heart
muscle
 Can be of sufficient strength, frequency, and duration

to cause disruption of normal cardiac function
 Usually only possible during certain medical

procedures as the electric current needs to be
focussed directly into the heart by some conductor
inserted by invasive means (for example Cardiac
Catheterisation)
Micro Shock
Conductor in
direct contact
with the heart
Current Current
out in
Prevention from Electric Shock
 Learn how to properly use
electrical equipment
 Visually inspect the condition of equipment
 Turn off the equipment before plugging or

unplugging
 Do not use the equipment when it is wet

Send to biomedical engineering
 Do not pull the plug out by the cord

 Avoid using 3-pin adapter or broken 3-pin plug
 Minimise the use of extension cords with

patient care equipment (they may compromise
electrical safety)
 Electrical safety testing should be performed

periodically by biomedical engineering or
supplier
Report damaged mains cords and plugs immediately!
Report ASAP
Source: ProSoundWeb Source: Sound-On-Sound
Labeling
 Typical marking that can be found on the medical
equipment:
• Name of the manufacturer

• Model number or name
• Electrical rating
• Class
• Protection Classification Source: ECRI On-site Photo
• IP rating
IP Rating
 IP (immersion protection) code indicates the degree of
protection against harmful ingress of water
 IP marking:
• IPX0 – no-protection
• IPX1 – vertically dripping (equivalent to 5 mm of rain water/minute
for duration of 10 minutes)
• IPX2 – dripping at 15° tilted
• IPX3 – spraying
• IPX4 – splashing
• IPX5 – jetting
• IPX6 – powerful jetting
• IPX7 – temporary immersion (water tight equipment)
• IPX8 – continuous immersion (water tight equipment)
Medical Equipment Planning,
Procurement and Management
Outline of Content
 Introduction
 Medical Equipment Planning Protocols
◦ Planning
◦ Procurement
◦ Construction Coordination
◦ Acceptance Testing & Commissioning
 Common Oversights
 Future Challenges
 Opportunities for the BME
Introduction
 Good medical equipment planning
practices will provide answers to:
◦ Is this the right equipment?

◦ Is the technology appropriate?
◦ Is the purchase cost-effective?
◦ Does this equipment improve the safety and
quality of care?
◦ Is this equipment good enough?
Planning
 Study and understand the project brief and schematic
drawings
 Developing the medical equipment list- provides a

platform for project team to discuss and decide on the
type and number of medical equipment required
 Estimating the medical equipment budget
 Preparing medical equipment descriptions and generic

utility requirements
 Coordinating with the architect/medical planner for

medical equipment placement
Planning – Sample Documents
Planning – Sample Documents
Procurement
 Preparing tender documents with neutral technical
specifications
 Pre-qualifying vendors for the tender

o Ensure competitive and comparable submissions from
vendors
 Issuing and receiving tenders to/from vendors
 Evaluating tender submissions
 Making recommendations
Procurement – Sample Documents
Construction Coordination
 Coordinating on-site construction works
related to medical equipment with other
consultants, project team members and
builders
 Supervision of the contractual obligations by

the medical equipment vendors
 Coordinating the final delivery of the

medical equipment and related installations
according to agreed schedules
Acceptance Testing &
Commissioning
 Supervising works carried out by vendors
 Using proven and tested protocols for

acceptance tests
 Recording information into an asset

management software
 Arranging for user training sessions
 Handing over medical equipment to end-users
Acceptance Testing &
Commissioning
 The supplier shall provide complete copies
of the following items to Biomedical
Engineering Services:
◦ user manual
◦ service or maintenance manuals
◦ circuit diagrams and drawings
◦ parts list
◦ PPM checklist according to manufacturer’s
recommendation
◦ other necessary documents/items
Acceptance Testing & Commissioning –
Sample Document
Common Oversights
 Installation of Ceiling Mounted or Wall Mounted
equipment
◦ Ceiling Mounted: Surgical lights, pendants/booms
◦ Wall Mounted: Examination lights, microscopes

◦ Area for installation should be clearly demarcated on drawings and
at location
◦ To avoid clashing with other installed M&E services – electrical

cables, ventilation ducts, medical gas piping, water and drain piping
◦ Close coordination with M&E consultants and Architect
◦ For wall mounted equipment, wall strength needs to be adequate –

may require wall stiffeners
Common Oversights
 Electromagnetic shielding for MRI
◦ Radius between isocentre of MRI magnet and nearby

sources of interference, such as AHUs, elevators,
electrical distribution boards, motors, generators,
roads (cars), railway (trains, subway)
◦ Can influence the homogeneity of the magnetic field
◦ Active and passive shielding requirements

 Active – magnet shimming
 Passive – special enclosed cabins
Common Oversights
 Environmental requirements
◦ For imaging equipment e.g. MRIs, CT Scanners,

Radiographic and Fluoroscopic systems
◦ Temperature: 18 – 22 degrees C
◦ Humidity: 40 – 60 % relative humidity
◦ Air conditioning system designed to handle these

requirements
Common Oversights
 Weight and dimensions of medical equipment
and their placements
◦ Delivery paths and door sizes for large equipment

need to be identified early
◦ Some can be table top or floor standing - heavy

equipment would need reinforced benches or tables
◦ Should be captured by the Architect in their loaded

drawings
Common Oversights
 Mostly can be overcome through:
◦ Thorough understanding of medical equipment pre-

installation requirements
◦ Regular communication with other consultants on the

project team, e.g. coordination meetings
◦ Review of schematic drawings – loaded drawings, 4-

wall drawings, room data sheets
Future Challenges
 Identifying equipment capabilities required to meet
expanding clinical needs
 Matching equipment capacity with utilization

demands and future growth
 Evaluating existing technology for reallocation ─ is

it outdated, reaching the end of its useful life, etc.
 Optimizing equipment configuration to address

operational issues
 Addressing patient safety concerns
Opportunities for the BME
 BME’s need to broaden their role to be a
more essential part of this process, through:
◦ Acquiring an understanding of the requirements
of the medical equipment planning process
◦ Determining which types of information the BME
department is most suited to manage based on
its experience and role within the organization.
External consultants may need to be hired.
◦ Having appropriate information, procedures, and
forms available in an accurate and accessible
format including literature, historical databases,
and questionnaires to facilitate the process
Biomedical Asset
Management Systems
Outline of Content
 Introduction
 Importance of a Good System
 Screenshot Examples
 Guide on Selecting a System
Introduction
 Central database/registry for all medical
equipment
 Can be
◦ Records on paper
◦ Excel spreadsheets
◦ Simple software programme (e.g. Access database)
◦ Sophisticated computerised software systems
Introduction
 Records information such as
◦ Asset number
◦ Equipment type/description
 Using nomenclature e.g. UMDNS
◦ Model name and number
◦ Manufacturer name
◦ Serial number
◦ PO/Contract number cross reference
◦ List of software, components, accessories
◦ Date of acceptance and warranty expiry
◦ Designated location of equipment
◦ Departmental owner
Introduction
 Asset Number
◦ Unique identifier
◦ Important reference, the link between what is
physically present and information in the system
◦ Frequently hospitals have parallel numbering systems
for their equipment
 E.g. accounting department and the biomedical
engineering department assign unique numbers
 Important to standardize on a single number to be used
to track equipment in the hospital
Importance of a Good System
 Improve the biomedical engineering
department’s performance and efficiency, thus
reducing operating costs
 Lists all equipment and service information

◦ Schedule for inspection or preventive maintenance
◦ Records of repairs
◦ Equipment maintained by vendors or 3rd party service
organizations
Importance of a Good System
 If there is no such central system
◦ Lose opportunities to save money by getting volume
discounts for services or parts
 e.g. where one department ordered service by a vendor,
unaware that the equipment was in fact covered under a
service contract
◦ Very cumbersome to check inventory to determine if

any equipment are impacted by hazards and recalls
Screenshot Examples (ECRI-AIMS)
 Equipment Information
 Equipment History Log
 Equipment Preventive Maintenance Scheduling
 Setting the Preventive Maintenance Schedule
 Equipment Service Contract Information
 Work Order Request
 Work Order
 Reports
 Reports
 Parts Inventory
 PDA/Smartphone/Tablet module
Guide on Selecting a System
 Identify IT infrastructure system requirements
 Identify software system licensing requirements
 Determine availability of local support and

training
 Ask for a list of installed customer base
 If there is a nearby reference site, call the
person or better still, visit the site to look
at the system and get user feedback
 Ability of the system to link or interface
with other software/databases
◦ E.g. Hospital information systems, finance or
procurement software.
 Can the data from your existing system be
converted/migrated to the new system?
◦ Cost and time required
 Standard package and optional add-ons available
◦ What is the cost of each package and additional
modules?
 Is there a limitation in the number of users

which can access the software?
 Is there an annual licensing fee attached?

◦ For training, support, fixes and upgrades
Summary
 Electrical Safety
 Medical Equipment Planning
 Asset Management

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Technology Management:

Medical Equipment Design

Class - To inform equipment user on the method

Protection Classification – To inform equipment user on

 Mains power is “Earth” seeking

Copper Human Plastic, Perfect

0.1 1 1000 1 million 10million 100 million

Earth Protective Equipotential

Common symbols on the equipment

Source: ECRI On-site Photo

 Double insulation (two layers of insulation)

17 © ECRI Institute Source: ECRI On-site Photo

 There are several protection classifications

 Used at different areas and application thus have

 To ensure adequate safety for patient and operator

 BF type equipment but this equipment is safe

 Body in a square box with defibrillator paddles

 The heart is more sensitive to electrical

 This equipment can be used during cardiac

 Heart in a square box symbol printed on

 This device can remain connected to the

• Macro Shock – Current that leaks from

Source: MDUT Training Material

 The significant component is the CURRENT

 The term ‘leakage’ current refers to current

 Electrical current in excess of 10 mA passing

 Can be of sufficient strength, frequency, and duration

 Usually only possible during certain medical

Source: MDUT Training Material

 Visually inspect the condition of equipment

 Turn off the equipment before plugging or

 Do not use the equipment when it is wet

 Do not pull the plug out by the cord

 Minimise the use of extension cords with

 Electrical safety testing should be performed

• Name of the manufacturer

◦ Is this the right equipment?

 Developing the medical equipment list- provides a

 Estimating the medical equipment budget

 Preparing medical equipment descriptions and generic

 Coordinating with the architect/medical planner for

 Pre-qualifying vendors for the tender

 Issuing and receiving tenders to/from vendors

 Evaluating tender submissions

 Supervision of the contractual obligations by

 Coordinating the final delivery of the

 Using proven and tested protocols for

 Recording information into an asset

 Arranging for user training sessions

 Handing over medical equipment to end-users

◦ Wall Mounted: Examination lights, microscopes

◦ To avoid clashing with other installed M&E services – electrical

◦ Close coordination with M&E consultants and Architect

◦ For wall mounted equipment, wall strength needs to be adequate –

◦ Radius between isocentre of MRI magnet and nearby

◦ Can influence the homogeneity of the magnetic field

◦ Active and passive shielding requirements

◦ For imaging equipment e.g. MRIs, CT Scanners,

◦ Humidity: 40 – 60 % relative humidity

◦ Air conditioning system designed to handle these

◦ Delivery paths and door sizes for large equipment

◦ Some can be table top or floor standing - heavy

◦ Should be captured by the Architect in their loaded