BIOMEDICAL EQUIPMENT II DBE 221

ELECTRO-MEDICAL EQUIPMENT
These are Electro-Medical Devices (EMD) which can be used for Therapeutic (e.g.,
surgical instruments, lasers) or Diagnostic (e.g., imaging equipment, monitoring
devices) purposes. Stand-alone software, provided it meets the definition of a medical
device, can also fit the EMD category.

Electro-Medical Devices are covered by the Medical Device Directive (MDD;

93/42/EEC) and are subject to classification rules 9 to 11, plus special rules.
Manufacturers must adhere to a specific series of standards, including the IEC
60601 series. (Intern’l Electrotechnical Comm’n)

In this particular course we are going to look at Operation, Repairs test, repair,
specification and maintenance for electro-medical equipment, such as electrocardiographs,
electroencephalographs, and diathermy machines. How to specify an equipment – Main
purpose, - Capacity - Composition parts, - Accessories if required – Power requirements,
Warranty, Training

ELECTROCARDIOGRAPHS
Introduction
The beat of the heart, including the electrical signal transmitted to create the beat, is
one of the most familiar waveforms found in health care. It deserves this status. The
electrical activity of the heart is fairly simple to measure and tells a great deal about the
health of the patient.

Electrocardiogram refers to the recording of electrical changes that occurs in heart

during a cardiac cycle. It may be abbreviated as ECG or EKG while Electrocardiograph
is an instrument that picks up the electric currents produced by the heart muscle during
a cardiac cycle of contraction and relaxation. Electrocardiographs detect the electrical
signals associated with cardiac activity and produce an ECG, a graphic record of the
voltage versus time.

They are used to diagnose and assist in treating some types of heart disease and
arrhythmias, determine a patient’s response to drug therapy, and reveal trends or
changes in heart function. Multichannel electrocardiographs record signals from two or
more leads simultaneously and are frequently used in place of single-channel units.
Some electrocardiographs can perform automatic measurement and interpretation of
the ECG as a selectable or optional feature. Specs for an ECG Purpose to measure and
record Interpretive ECGraphs, 12-lead, High resolution thermal printer, Storage capacity
of say 75ECGs, Complete alpha-numeric key board, Mains & battery operated say for 3
hrs, Complies wz IEC 601-1, Power requirements 220-240V/50HZ

Electrical activity of the heart

The heart generates electrical signals to contract (pump blood). Cells within the heart
have the ability to depolarize and repolarize, and this process generates electrical
energy. The electrical signal in the heart begins at the sinoatrial (SA) node, which
stimulates the atria (the two upper chambers of the heart) to contract. The signal then
travels to the atrial ventricular (AV) node, followed by the Bundle of His, and then
through the Purkinje network, which stimulates the ventricles (the two lower chambers
of the heart) to contract. When the ventricles are being stimulated to contract, the atria
are repolarizing.

The first little upward notch of the ECG waveform is called the P wave. The P wave
indicates that the atria are contracting to pump blood. The next part of the ECG is a
short downward section connected to a tall upward section. This part is called the QRS
complex. When the Bundle of His fires, the ventricles contract to pump blood. The large
amplitude of voltage is required because the ventricles are the most muscular and
dense part of the heart. The next upward curve is called the T wave. The T wave
indicates the resting period (repolarization) of the ventricles.

The number of waves per minute is the heart rate. Notice that heart rate is measured
per minute rather than per second as most other electrical signals.

The amplitude of the QRS segment can be measured at the skin and is about 1 millivolt
(mV).
Working principle of electrocardiograph:

ECG units consist of the ECG unit, electrodes, and cables. The 12-lead system includes
three different types of leads: bipolar, augmented or unipolar, and precordial. Each of
the 12 standard leads presents a different perspective of the heart ’s electrical activity;
producing ECG waveforms in which the P waves, QRS complex, and T waves vary in
amplitude and polarity. Single-channel ECGs record the electric signals from only one
lead configuration at a time, although they may receive electric signals from as many as
12 leads. Non-interpretive multichannel electrocardiographs only record the electric
signals from the electrodes (leads) and do not use any internal procedure for their
interpretation. Interpretive multichannel electrocardiographs acquire and analyze the
electrical signals.

It works on the principle that a contracting muscle generates a small electric current of
about 1Mv that can be detected and measured through electrodes suitably placed on
the body. For a resting electrocardiogram, a person is made to lie in the resting position
and electrodes are placed on arms, legs and at six places on the chest over the area of
the heart. The electrodes are attached to the person ’s skin with the help of a special
jelly. The electrode picks up the current and transmit them to an amplifier inside the
electrocardiograph. Then electrocardiograph amplifies the current and records them on
a paper as a wavy line. In an electrocardiograph, a sensitive lever traces the changes in
current on a moving sheet of paper. A modern electrocardiograph may also be
connected to an oscilloscope, an instrument that display the current on a screen.

Operating steps
After the electrodes are attached to the patient, the user selects automatic or manual
lead switching, signal sensitivity, frequency response range, and chart speed. In some
units, the operator can choose the lead groupings, their sequence, and the recording
duration for each group. In standard 12-lead tracings, signals from each group of leads
(i.e., bipolar, augmented, precordial) can be recorded for 2.5 seconds. For a rhythm
strip, one lead (usually lead II) is recorded for a full 12 seconds.

Repair and maintenance

Because electrocardiographs have electrical safety standards that are well established
and adhered to by all major manufacturers, few problems are associated with their use.
Of these, the most common is artifact or noise (e.g., broken electrode wires, poor
electrode cleaning or improper application, poor skin preparation, patient movement,
baseline drift, and interference). Incorrect placement of ECG leads can cause an
abnormality to be overlooked. Chest wall thickness can also affect diagnostic accuracy.

Maintenance
Below are a few maintenance tips;

i. Keep the electrocardiograph, reusable electrodes, and the patient cable clean.
Patient contact with contaminated equipment can spread infection.
ii. Never let soap or water come into contact with the electrocardiograph ’s internal
printer, connectors, or jacks.
iii. Never immerse the electrocardiograph or the patient cable in liquid.
iv. Never autoclave or steam clean the electrocardiograph or the patient cable.
v. Never pour alcohol directly on the electrocardiograph or the patient cable, and
never soak any components in alcohol.
vi. If any liquid enters the electrocardiograph, remove the Electrocardiograph from
service, and have it inspected by a qualified service person before using it again.

Daily recommended inspections

i. Check for cracked or broken patient cable, patient electrodes, power cord,
communications cables, display, and enclosure.
ii. Check for bent or missing pins on all cables.
iii. Check all cable and cord connections; reseat if any connectors are loose.
iv. Using an ECG simulator.

Artefacts
These are unwanted futures with in an ECG waveform. Also known as noise.
There are many types of noises and some of these include:
i. Power line interference/ AC interference
Causes
 The patient or technician was touching an electrode during recording.
 The patient was touching a metal part of an exam table or bed.
 A lead wire, patient cable, or power cord are broken.
 Electrical devices in the immediate area, or lighting, or wiring concealed in walls
or floors are interfering.
 An electrical outlet is improperly grounded.
 The AC filter is turned off or set incorrectly.

Actions for AC interference

 Verify that the patient is not touching any metal.
 Verify that the AC power cable is not touching the patient cable.
 Verify that the proper AC filter is selected.
 If interference persists, unplug the electrocardiograph from AC power and run it
on the battery. If this solves the problem, you’ll know that the noise was
introduced through the power line.
 If interference still persists, the noise may be caused by other equipment in the
room or by poorly grounded power lines. Try moving to another room.

ii. Muscle contractions/ muscle tremor

Causes
 The patient is uncomfortable, tense, and nervous.
 The patient is cold and shivering.
 The exam bed is too narrow or short to comfortably support arms and legs.
 The arm or leg electrode straps are too tight.
Actions
 Verify that the patient is comfortable, warm, and relaxed.
 Check all electrode contacts.
 If interference persists, turn the muscle-tremor filter on.
  If interference still persists, the problem is probably electrical in nature. See the
suggestions for reducing AC interference (in a related troubleshooting tip)

iii. Electrode contact noise

A dot might be flashing on the lead-status screen. Or one or more leads might appear
as a square wave.

Causes
 Electrode contact might be poor.
 A lead might be loose.
 A lead might be defective
Actions
 Replace the electrode.
 Verify that the patient’s skin has been properly prepared.
 Verify that electrodes have been properly stored and handled.
 Replace the patient cable

iv. Motion Artifacts

v. Baseline wandering
Wandering baseline is an upward and downward fluctuation of the waveforms.

Causes
 Electrodes are dirty, corroded, loose, or positioned on bony areas.
 The electrode gel is insufficient or dried.
 The patient has oily skin or used body lotions.
 Rising and falling of chest during rapid or apprehensive breathing
Actions
 Clean the patient’s skin with alcohol or acetone.
 Reposition or replace the electrodes.
  Verify that the patient is comfortable, warm, and relaxed.
 If wandering baseline persists, turn the baseline filter on.

Filters
The noise above can be removed by use of filters. Different filters are used to correct
ECG waveforms and some of these include;
 The notch filter
 High Band pass filter
 Low band pass filter

Trouble shooting the ECG

Some of the common System problems include;
i. The electrocardiograph won't turn on when it is plugged in
Possible Causes
 The AC power connection is faulty.
 An AC fuse is blown.
 There is no AC power.
Actions
 Check the AC power source.
 Check the AC fuses.

ii. The electrocardiograph won't turn on when it is unplugged

Possible Causes
 The battery is disconnected or incorrectly connected.
 The battery is low, not charging, depleted, or bad.
Actions
 Check the battery connections
 Recharge the battery.
 Replace the battery.

iii. The electrocardiograph shuts down during printing

Possible Causes
  The battery is low or bad.
Actions
 Recharge the battery.
 Replace the battery.

Specification
 Approx. Dimensions (mm): 120 x 400 x 350
 Approx. weight (kg): 6
 Consumables: Batteries, cables, electrodes
 Price range (USD): 975 - 6,000
 Typical product life time (years): 10
 Shelf life (consumables): 1-2 years for disposable electrodes/sensors

ELECTROENCEPHALOGRAPHS (EEG)
Introduction
Measuring the activity and function of the brain is more complex than measuring the
electrical activity of the heart. Signals from the brain are more random and have only
recently been translated into specific applications. Even though brain signals can be
extremely useful in patient assessment, in general, measuring the function of the brain
is far less common than other technology-facilitated patient care tools.

Review of neuro-anatomy and physiology

Here is a brief review of basic neuro-anatomy and physiology terminology.

 Neuron – This is the most basic cell associated with the brain.
 Brainstem – This portion of the brain controls life sustaining functions.
 Cerebellum and cerebrum – These major parts of the brain control various body
 functions and memory.
 Ventricles of the brain – These spaces within the brain are important because
implants and monitors often involve these areas.
 Spinal cord sections – The spinal cord includes the cervical, thoracic, lumbar,
and sacral regions.
 Cerebral spinal fluid (CSF) – This fluid is very important because it cushions the
brain and can be monitored to assess brain health.

Electrical activity in the brain

Electroencephalography (or electroencephalogram) the electrical signals from the brain
can be measured using many electrodes on the scalp. EEG signals created inside the
brain are complex and relatively random. Measured at the scalp, EEG amplitudes are
very small, in the range of microvolts. Specifically,

EEGs are used to:

 Evaluate brain lesions

 Identify epilepsy
 Evaluate mental disorders
 Assess sleep patterns
 Evaluate brain responses to stimuli

Patterns and information are more difficult to obtain from an EEG than from an ECG.
Nevertheless, tests are often performed that evaluate the EEG waveform in response to
an input like light or sound. Since data can be gathered from many people, a typical
EEG response can be predicted and compared to the response of a particular patient.
Noise, motion artifacts, and ECG signal interference can present some major issues
because EEG waveforms appear at the scalp in such low voltages.

Brain signals, which are grouped based on frequency, are divided into alpha, beta,
theta, and delta waves. Different signals are prominent depending on the age and
activity of the patient.

i. Alpha – 7.5–13 Hz; present during rest and relaxation.

ii. Beta – 14 Hz and higher; present for patients who are alert and awake. These
waves have the lowest amplitude.
iii. Theta – 3.5–7 Hz; normal for awake children.
 iv. Delta – 3 Hz or below; common during sleep and in infants. These waves have
the highest amplitude.

Working principle of the EEG machine

An EEG device records electrical signals from the brain, specifically postsynaptic
potentials of neurons originating from the cerebral cortex, through electrodes that are
attached to the subject's scalp.
The electrodes attached to the subject's scalp transmit the electrical signals produced
by the brain to the EEG monitor. Since these electrical signals are very small (of the
order of 10s of microvolts) the EEG acts as an amplifier, typically amplifying them by
10,000 times, as well as a device to measure them.
An EEG lets a practitioner view, in real time, and record electrical impulses from the
brain and observe changes to those impulses. This can indicate the general mind state
of the subject being monitored.

EEG recording techniques

Encephalographic measurements employ recording system consisting of
- Electrodes with conductive media
- Amplifiers with filters
- A/D converter
- Recording device.
Electrodes read the signal from the head surface, amplifiers bring the microvolt signals
into the range where they can be digitalized accurately, converter changes signals from
analog to digital form, and personal computer (or other relevant device) stores and
displays obtained data. Scalp recordings of neuronal activity in the brain, identified as
the EEG, allow measurement of potential changes over time in basic electric circuit
conducting between signal (active) electrode and reference electrode [12]. Extra third
electrode, called ground electrode, is needed for getting differential voltage by
subtracting the same voltages showing at active and reference points. Minimal
configuration for monochannel
EEG measurement consists of one active electrode, one (or two specially linked
together) reference and one ground electrode. The multi-channel configurations can
comprise up to 128 or 256 active electrodes.
Block Diagram of EEG Machine

Montage selector:
Montages are patterns of connections between the electrodes and the recording
channels. The montage selection switch is used for selecting a particular channel.
Different channels convey different information. Montages are always symmetrical and
hence in the 10-20 electrode placement system the electrodes are also placed
symmetrically. The EEG signals are transmitted from the electrodes to the montage
selector panel. The montage selector of an EEG machine is a large frame which
consists of different switches so as to allow the user to select the desired electrode pair.
Pre-amplifier
The function of pre-amplifiers in the EEG measuring system is clear from the name
itself. As the EEG signals are having amplitude levels in microvolt range it is
compulsory that they are to be amplified before further processing. It is to ensure that
the information from the EEG electrodes is not affected by any external noise. We
normally use high gain, high CMRR operational amplifiers as preamplifiers due to its
versatile features.

Filters and amplifiers

The muscle artifacts (noise) are a major problem regarding the EEG waveform. These
noises can make the representation dishonest. So we have to filter out these noise
contents. This function is done by a bank of filters in the EEG machine systems, which
are selected according to the need. Amplifiers are used here also to improve the
amplitude levels of EEG waveform.

Analog to Digital Converters (ADC)

For the detailed analysis of the EEG waveform, we use computers and oscilloscopes.
As the computers only accept digital data we have to convert the analog EEG
information in to digital form. The function of ADC is to convert the analog EEG signal to
digital form. Thus the computer can store the EEG waveform for future reference.

Writing recorder and paper drive

The writing part of an EEG machine is usually consists of an ink type direct writing
recorder. The recorder will be a chart paper which is driven by a synchronous motor.
For the clear representation of the EEG waveform an accurate and stable paper drive
mechanism is provided by the synchronous motor. Also there are provisions to control
the paper speed.
Artifacts
Among basic evaluation of the EEG traces belongs scanning for signal distortions called
artefacts.
Usually it is a sequence with higher amplitude and different shape in comparison to
signal sequences that doesn’t suffer by any large contamination. The artefact in the
recorded EEG may be either patient-related or technical. Patient-related artefacts are
unwanted physiological signals that may significantly disturb the EEG. Technical
artefacts, such as AC power line noise, can be decreased by decreasing electrode
impedance and by shorter electrode wires. The most common EEG artefact sources
can be classified in following way:
Patient related:
 Any minor body movements
 EMG Electromyography
 ECG (pulse, pace-maker)
 Eye movements
 Sweating
Technical:
 50/60 Hz
 Impedance fluctuation
 Cable movements
 Broken wire contacts
 Too much electrode paste/jelly or dried pieces
 Low battery
Excluding the artefact segments from the EEG traces can be managed by the trained
experts or automatically. For better discrimination of different physiological artefacts,
additional electrodes for monitoring eye movement, ECG, and muscle activity may be
important.
Implementation of General maintenance for electro-medical equipment
Inspection and preventive maintenance (IPM)
IPM procedures
Using the correct and appropriate procedures for equipment maintenance can make the
difference between having reliable and properly functioning equipment and not.
Performing IPM activities should be defined prior to execution of the inspection or
maintenance work, through a careful review of each type of equipment (or model).
Most IPM procedures are completed by technical personnel from the clinical
engineering department. In some cases, however, routine and easy to perform tasks
are completed by the user. This saves time for technical personnel to perform more
technically complex and critical tasks and also provides the user with a sense of
ownership. The type of inspection the user might perform would be pre-use or daily
checks, where required. Examples of this might be daily calibration of portable blood
glucose monitors, daily testing of defibrillators or checking the standard calibration of
laboratory equipment. It is the responsibility of the clinical engineering department to
train the user to perform these tasks. See section 5.3.9 for further information on user
interaction.

A sample policy Inspection and preventive maintenance procedure

Equipment to be covered by the program will typically include: life support equipment,
laboratory equipment, surgical and critical care equipment, imaging equipment,
equipment which could cause patient injury or death if it fails, equipment required to be
maintained by regulations, equipment on an outside vendor maintenance program,
equipment under lease where maintenance is part of the lease, and equipment under
warranty.
Procedure
i. All equipment due for maintenance needs to be identified one month prior to the
maintenance date. The list of maintenance tasks can be generated automatically
by a computerized maintenance management system (CMMS), if in place.
ii. Parts required for preventive maintenance are ordered and made available for
the equipment in this period.
iii. The inspection and preventive maintenance (IPM) tasks will be assigned to
specific biomedical technicians.
iv. Work orders will be generated and distributed to the assigned technicians.
v. Maintenance will be performed in accordance with the established IPM
procedure. These IPM procedures will be based on manufacturer ’s
recommendations, industry recommendations and facility experience.
vi. The assigned technician will document on the work order the inspections and
maintenance performed and any other important observations.
vii. When the IPM is completed successfully, the equipment will receive an IPM
sticker or other identification denoting its maintenance status.
viii. When the IPM and documentation is completed, the work order will be updated in
the records and/or the CMMS.
ix. If scheduled work cannot be completed (i.e. parts are needed, equipment is in
use, equipment cannot be located), the reason is documented on a work order.
This work will be followed up at a later date.
x. When scheduled maintenance is performed by an outside vendor, the biomedical
engineering department will notify the vendor and schedule the maintenance
service. When maintenance and documentation is completed, the work order is
subsequently updated in the records and/or the CMMS.
xi. Life support equipment due for maintenance but still in use by patients will be
scheduled for maintenance after it is removed from the patient. The technician
will work closely with the clinical department to schedule the maintenance as
soon as possible.
xii. Equipment scheduled for IPM but which cannot be located, can be identified as
“could not locate” only after a concerted effort to locate the device has been
made, the equipment owners have made every attempt to locate it and the
biomedical engineering supervisor/manager has approved the device to be
marked in this way.
xiii. If the equipment has not been located for two consecutive maintenance cycles, it
will be removed from service and deleted from the records, and/or deactivated in
the CMMS.
xiv. To assure IPM quality technician competency and the correct execution of IPM,
procedures and practices need to be evaluated by clinical engineering
management.
xv. Maintenance completion rates, lists of equipment unable to be located, PM yield
rates and other quality or performance related statistics will be reported to the
relevant safety committee and the clinical engineering department staff at least
quarterly.

Longer or shorter preventive maintenance intervals are adopted after documented

justification based on previous PM yield data, relevant safety information and other
service history records.

Problem identification
When IPM identifies a problem, the device can either be set aside for later repair, so the
IPM work can continue on schedule, or the repair can be completed as part of the IPM
process. If the IPM activities or related repairs are not accomplished in a certain pre-
defined period, the work order should be left open and the staff should inspect or repair
the device as soon as reasonably possible. Higher priority devices not inspected in
previous IPM periods should be located and inspected first. Appendix A.5 presents a
sample policy regarding corrective actions identified during preventive maintenance.

Corrective maintenance
Troubleshooting and repair
Identification of a device failure occurs when a device user has reported a problem with
the device. As mentioned earlier, it may also occur when a technician in the clinical
engineering department finds that a device is not performing as expected during IPM.
In order to return equipment to service as quickly as possible, efficient troubleshooting
is required to verify the failure and determine its origin. In some cases the technician will
find that the device itself has failed and must be repaired. The technician then
determines what steps are necessary to correct the problem and return the device to full
functionality. The technician initiates the corrective maintenance, performing some
steps themselves and making use of in-house expertise or external service providers
when necessary. This corrective maintenance may be accomplished at various levels:
• Component level. Component-level troubleshooting and repair isolates the failure to a
single, replaceable component. In electrical devices, mechanical devices, and for
discreet components of electronic devices (such as resistors or capacitors in an
electronic circuit, or fuses) this is often the most effective repair approach. In relation to
electronic devices, however, component-level repair may be time-consuming and
difficult. Modern electronic circuit boards (digital circuit boards, especially) are
frequently not repairable at the component level. In those cases board-level or even
system-level repair need to be considered.
• Board level. For electronic devices, it is common to isolate failures to a particular
circuit board and to replace the entire circuit board rather than a given electronic
component.
• Device or system level. In some cases even board-level troubleshooting and repair is
too difficult or time consuming. In such cases it can be more cost-effective to replace
the entire device or subsystem.
It is important to choose an appropriate level of maintenance for each situation.
This is dependent on the availability of financial, physical and human resources as well
as on the urgency of a particular repair request. For high-priority cases, for example,
device-level repairs may be preferred. When more time is available, board- or
component-level repair may be feasible. If component-level repair is proposed, part
replacement may be necessary. For this approach, there are a few options from which
to choose.
The replacement can be made with specialized parts from the manufacturer, with
generic parts of the same or higher specifications (e.g. fuses), or with spares reclaimed
from non-functional or obsolete equipment (only after thorough risk assessment and
permission of the clinical engineering manager).
In some cases, the technician will find that the device performs within its design
specifications, as defined by the manufacturer. In such instances, it is necessary to
communicate with the device user and examine the work environment to determine why
the device did not function as expected. See section

Factors affecting equipment failures

When investigating an unexplained failure, environmental factors should be taken into
due consideration. For example, medical devices that require electrical power may be
adversely affected by power issues. Ideally, electrical power should have a steady
voltage (of the appropriate value); be free of transient distortions, such as voltage
spikes, surges or dropouts; and be reliable, with only rare loss of power.
Unfortunately, these ideal characteristics do not always exist in many developing
countries. Technical personnel should collaborate with those responsible for the
electrical power system in the health-care organization to help make the system
function as effectively as possible.
This may include purchasing voltage regulators, installing uninterruptable power
supplies (UPS), using surge protectors, and avoiding connecting extension leads/plug
boards in series.
Furthermore, technical personnel should work with the facility personnel to ensure that a
functional back-up generator is in place and that the switch to auxiliary power is made in
under 10 seconds.
Another alternative may be to select and purchase equipment that is battery operated.
When considering acquiring new equipment, it is also important for the technical
personnel to ensure that the electrical power system is capable of supporting it. When it
cannot, it often makes sense to opt for less sophisticated and more robust equipment.

Similarly, technical personnel should be aware of how medical devices interact with
other utility systems (e.g. medical gas and vacuum systems, temperature control and
ventilation systems, water supply, information technology and communication
infrastructure, etc.). And, once again, they should collaborate with others in the
organization to optimize the ability of the utility systems to support medical equipment.1
Unique aspects of the physical environment, such as high temperature and humidity,
can adversely affect medical equipment designed for use in temperate climates or
controlled environments.
Maintenance procedures in a particular country or region may need to be adjusted
based on these local factors.
The age and condition of the health-care facility may also play a role in medical
equipment failure. Over time, utilities systems will degrade and may become overloaded
and/or outdated. Older facilities will have been built to older standards. Even new
facilities may not meet all applicable standards. Therefore, it is often necessary to test
the utility infrastructure rather than to assume it is functioning appropriately.

Inspection and return to service

After completion of repair, it is essential to conduct a performance and safety
inspection, and in some cases a recalibration may be required. These activities will
measure the performance of the device and allow for any adjustments necessary to
return the equipment to full functionality. Once this is complete, the device may be
returned to use in patient care.

Reporting
For IPM activities, the technician typically has a detailed checklist to follow in order to
record the results. Having such a checklist also serves as a reminder of each step in the
IPM process and thus helps avoid skipping or overlooking specific steps. Recording
measurements and documenting the final results (either as ‘pass/fail ’ or numeric
values) aids in the execution of future maintenance work, including repairs. Having the
last few sets of IPM checklists on-hand for reference during maintenance is extremely
helpful for decision-making. For example, for equipment with therapeutic energy output,
including the energy readings from the last few inspections on the next inspection form
helps identify potential problems, as equipment energy levels may slowly drift over time.
Additionally, knowing when routine maintenance parts were last replaced helps identify
if or when the parts should be replaced again, and helps explain the condition of the
parts during the current inspection.
For CM, the technician records what actions were taken, including the time and the cost
of those actions.

Safety
There are various safety aspects to consider when implementing a successful and
effective maintenance program, such as the safety of technical personnel while
performing maintenance, safety of the user following maintenance, and general
infection control.
The safety of equipment maintenance personnel is fundamental. Therefore, it is
important to have a lock out/tag out policy to protect personnel from unexpected
activation of equipment and release of stored energy. This policy ensures that when
working on electrical equipment it is essential to disconnect it from the electrical power
source. One or more physical locks may be applied to keep the power source
disconnected (‘lock out’) so that it is not inadvertently reconnected before the repair is
completed. When it is not possible to physically lock out the power source, prominent
signage should be posted (‘tag out’).
Furthermore, personnel should be aware, prior to performing maintenance work, of
particular medical technologies that may present special hazards such as chemical
hazards from chemotherapeutic agents and from other sources, radiation hazards from
radiation-generating equipment and radiopharmaceuticals, magnetic field hazards from
magnetic resonance imaging (MRI) equipment, hazards from compressed gas
cylinders, etc. Training in personal protective equipment (PPE) and techniques that will
allow technical personnel to work safely in hazardous conditions are critical. It is
preferable to have PPE readily available within the clinical engineering department for
hazardous maintenance.
Following maintenance, especially after procedures that may have affected the safety
features of a medical device, technical personnel should verify that the device is safe to
use, mechanically and electrically. Particular attention is given to electrical safety for
medical devices such that ground resistance and leakage currents are measured to
ensure that they are within applicable limits.
(In the absence of electrical safety test equipment, technical personnel must rely on
careful repair techniques and simple electrical tests to verify device integrity). Clinicians
should be advised to check the settings of the device and to perform basic operational
checks prior to using the device with patients. When direct communication is not
possible, a prominent note should be placed on the device so that it is not used without
being checked by the clinician.
Lastly, when working in the clinical environment, technical personnel should be aware
of infection control risks that they might encounter (patients with airborne infections
such a tuberculosis, for example) and, if there is any doubt, they should ask clinicians in
the area. In particular, if asked to work on a medical device that appears to be
contaminated, they should request assistance in cleaning the device from the clinical
user, who will have knowledge regarding the potential contaminants and their
associated hazards. Additionally, technical personnel should be aware of infection
hazards that their work might create for patients.
For example, patients with compromised immune systems (certain organ transplant
patients, patients with AIDS, and others) or otherwise susceptible to infection (such as
premature infants) can be severely affected by molds and spores disturbed and
dispersed by maintenance activities in the clinical environment. Again, when in doubt,
equipment maintainers should communicate with clinicians about potential risks and
ways to manage those risks. See Appendix A.6 for a sample infection control policy.