Medical Equipment

Quality Assurance:
Inspection Program Development
and Procedures

J. Tobey Clark
Director, Instrumentation & Technical Service,
Faculty, Biomedical Engineering/School of Engineering

Michael Lane
Associate Director, Instrumentation & Technical Services

Leah Rafuse
Clinical Engineer, Instrumentation & Technical Services

Instrumentation & Technical Services

University of Vermont
280 East Avenue, Suite 2
Burlington, VT 05401
Chapter 1: Introduction.............................................................................................. 2
Chapter 2: Definitions................................................................................................ 3
Chapter 3: Using a Risk-Based Assessment for Establishing a
Medical Equipment Maintenance Program....................................... 5
Chapter 4: General Procedures...............................................................................11
Chapter 5: Electrical Safety.................................................................................... 24
Chapter 6: Equipment Inspection Procedures.................................................... 37
General Equipment........................................................................................................ 38
Apnea Monitor.................................................................................................................41
Aspirator.......................................................................................................................... 45
Cardiac Output Unit........................................................................................................ 49
Central Station Monitoring System.............................................................................. 52
Compression Unit........................................................................................................... 55
Defibrillator..................................................................................................................... 59
Electrocardiograph......................................................................................................... 65
Electrosurgical Unit........................................................................................................ 69
Enteral Feeding Pump................................................................................................... 73
External Pacemaker....................................................................................................... 77
Fetal Monitor................................................................................................................... 80
Hypo/Hyperthermia Unit............................................................................................... 84
Infant Incubator.............................................................................................................. 88
Infusion Pump................................................................................................................. 94
Non-Invasive Blood Pressure Monitor......................................................................... 99
Patient Monitor............................................................................................................. 103
PCA Pump.......................................................................................................................110
Phototherapy Unit.........................................................................................................116
Pneumatic Tourniquet...................................................................................................119
Pulse Oximeter.............................................................................................................. 123
Radiant Warmer............................................................................................................ 127
Sphygmomanometer.....................................................................................................131
Therapeutic Stimulator................................................................................................ 134
Therapeutic Ultrasound................................................................................................137
Ventilator........................................................................................................................141
Appendix 1: Standards.............................................................................................. 147
IEC 60601-1..................................................................................................................147
IEC 62353......................................................................................................................147
NFPA 99......................................................................................................................... 148
The Joint Commission.................................................................................................. 148

©University of Vermont, Rev. 2 – Confidential 1

 CHAPTER 1: Introduction

The purpose of this document is to provide The publication is organized into four primary
guidance in establishing and managing a medi- sections:
cal equipment quality assurance (QA) program • A glossary of terms
and to present detailed procedures for inspec- • Background information on establishing and
tion, preventive maintenance, safety evaluation, managing a program including goals, meth-
and performance testing. ods, device inclusion and rating criteria, and
The target audiences for this publication standards
are those responsible for establishing and • General and device-specific procedures and
managing medical equipment QA program, forms for inspection, preventive mainte-
and staff performing inspections and device nance, safety evaluation, and performance
testing. Readers should have a basic techni- testing
cal background and some exposure to medical • An appendix with reference information
equipment in healthcare. The book does not Forms, tables, diagrams, illustrations, and photos
provide background information on clinical or are used to aid in the understanding of the
technical concepts or medical equipment prin- content.
ciples of operation. The publication takes into consideration
Medical equipment QA is part of an over- the advances in device reliability, reduced
all medical equipment management program preventive maintenance requirements, and
for a healthcare facility or system. A complete internal device surveillance (self test) along
program also includes corrective maintenance with changes in standards. Due to the ongoing
or repair, equipment control, asset management, efforts at global harmonization, international
health care technology planning, education, standards are used and referenced where
and activities directed toward improving medi- applicable, such as electrical safety testing
cal device-related patient safety. references IEC 62353.

Acknowledgements
The publication was funded by a grant from Fluke
Electronics Corporation (FEC). A number of diagrams,
illustrations and figures were provided by FEC as was
test equipment used in many of the photographs.

2 ©University of Vermont, Rev. 2 – Confidential

CHAPTER 2: Definitions

A meaningful preventive maintenance program Device inclusion: How a device is used

requires consistent terminology. This section determines whether or not to include the device
contains practical definitions of terms used in on the managed inventory. The device inclusion
this manual. categories include clinical equipment, utili-
Adverse event: Sometimes referred to as ties equipment, and general equipment. Most
a device incident. An event or circumstance equipment on the inventory will be classified as
arising during care that could have or did lead clinical equipment.
to unintended or unexpected harm, loss, or Electrical safety testing: Testing of equip-
damage. ment to assure it is electrically sound to avoid
Calibration: The process of determining the the possibility of microshock. Electrical safety
accuracy of a device by comparing it to a known testing involves testing the ground wire resis-
measurement standard. The device is then tance, current leakage to the chassis, and
adjusted to agree with the standard within a current leakage to the patient leads.
recommended tolerance. Minor adjustments to Equipment inventory: A record of medi-
achieve the specified accuracy are considered cal equipment used in a facility. The inventory
part of the calibration process. Major readjust- may include equipment that does not receive
ments and parts replacement are considered scheduled maintenance as well as managed
repairs and are not included in the calibration equipment for tracking purposes.
process. Estimated time: The estimated amount of
Class I medical equipment: Electrical time needed to perform the scheduled main-
medical equipment with accessible conductive tenance. The estimated time includes the
parts or internal conductive parts protectively time from test set up to the conclusion of the
grounded in addition to basic insulation. maintenance.
Class II medical equipment: Electrical Exception testing: Following scheduled
medical equipment that uses double insulation performance inspections, only failures are
or reinforced insulation for protection against documented. Equipment that has not been
electric shock in addition to basic insulation. documented as needing repair or adjustment
Clinical equipment: Medical equipment is assumed to be safe and ready for use. This
used for diagnosis, treatment, or monitoring of method of testing is useful when performing
a patient. Clinical equipment is further broken preventive maintenance and performance
down to life-support and non-life-support inspections on a large number of devices.
equipment. General equipment: Equipment that cannot
Clinical risk: The risk associated with the be classified as either clinical or utilities
clinical use of the equipment, taking into equipment.
account how invasive the equipment is to the Incoming inspection: A performance test
patient. performed on a piece of medical equipment
Corrective maintenance: Also known as before being put into use to verify the safety of
repair. Corrective maintenance entails isolating the device.
the cause of the device failure. Affected compo- Life support equipment: Medical equipment
nents are adjusted or replaced to restore normal that takes over a function of the human body
function. A performance inspection is performed and whose loss will cause immediate death.
following corrective maintenance before the
device is placed back into service to ensure
proper operation of the device.

©University of Vermont, Rev. 2 – Confidential 3

 Maintenance interval: Also referred to Procedure: Maintenance tasks that need to
as testing frequency or the length between be completed for effective performance testing
scheduled maintenance. Most commonly, the and preventive maintenance.
maintenance interval is given as a length of Quality assurance: A systematic process of
time (i.e. every 6 months), but can also be given checking to see whether a product or service is
in hours of equipment operation (i.e. every meeting specified requirements.
10,000 hours). Regulatory requirements: Specific criteria
Managed inventory: A record of medical that must be met as set forth in codes and
equipment used in the facility that only includes standards. Regulatory requirements often
equipment requiring scheduled maintenance. have the power of law behind them from a
Mean time between failures: The average governing body.
time between failures of a device or system. Repair: Also known as Corrective Mainte-
This is used as an indication of reliability. nance. Entails isolating the cause of the device
Nosocomial infection: An infection con- failure and replacing or adjusting affected
tracted by a patient during a hospital stay. components to restore normal function. A
Performance inspection: A procedure to performance inspection is performed following
ensure a device operates appropriately. The corrective maintenance before the device
device should meet safety and performance is placed back into service to ensure proper
requirements of regulatory agencies, the health- operation of the device.
care facility, and the manufacturer. Performance Risk assessment: The identification and
inspections will vary by device type and each quantification of possible hazards. A risk assess-
device type should have a written procedure ment involves a numerical scoring system to
that includes the characteristics that are tested, quantify the amount of risk.
how to test them, and acceptable operational Risk management: A process by which
limits. Performance inspections are performed possible hazards are identified and assessed.
periodically to ensure proper operation of Procedures are put into place to minimize the
devices prior to being put into service for the risks from the identified hazards.
first time, after a repair, or anytime the operation Standards: Also referred to as codes. Guide-
of the device is questioned. line documentation of practices agreed upon by
Physical risk: The risk associated with industrial, professional, or governmental orga-
device failure. nizations. The standard will usually establish
Preventive maintenance (PM): Periodic a specific value used for evaluation compliance
procedures to reduce the risk of device failure. with the standard.
The maintenance interval may be based on time Utilities equipment: Equipment that supports
(e.g. every 12 months) or operational usage (e.g. medical equipment, life support, infection con-
every 1,000 hours). Preventive maintenance trol, environmental, communication, or critical
is designed to ensure continuous operation of utility systems.
equipment. Preventive maintenance tasks may User checks: Also known as operator checks.
include replacing parts, lubricating, and adjust- Performance checks on medical equipment that
ing. Preventive maintenance excludes tasks can be performed by the clinical user. These
normally carried out by the user. are often simple operational checks that do not
Problem avoidance probability: The like- require the use of tools or test equipment.
lihood of a device to fail, based on historic
data related to medical equipment repair and
maintenance.

4 ©University of Vermont, Rev. 2 – Confidential

 CHAPTER 3: Using a risk-based
assessment for establishing a medical
equipment maintenance program

Goals of the maintenance program The University of Vermont has developed a

The goal of any medical equipment maintenance risk-based system for determining the mainte-
program is to ensure that medical equipment nance frequency. Intervals are established for
is safe, accurate, and ready for patient use. equipment inspection based on risk, require-
Quality assurance is achieved with periodic ments, logistics, and history. Written criteria are
checks of the equipment. The purpose of estab- used to identify risks associated with medi-
lishing risk-based maintenance intervals is to cal equipment per the Maintenance Strategy
provide high-quality, cost-effective inspections Worksheet. The risks include equipment
based on risk and function, historical data on function, physical risks associated with use, and
problems found, and the effect of maintenance equipment history as it relates to patient safety.
on the reduction of problems. Life support equipment is specifically identified
The PM/Inspection procedures should be and receives the highest priority for actions.
based on need that includes the maintenance The risk criterion is divided into five catego-
requirements of the device, risk classification, ries: clinical function, physical risk, problem
device function, and history of incidents. Main- avoidance probability, incident history, and reg-
tenance and performance inspections do not ulatory or manufacturer requirements. Devices
prevent random failures, particularly related to are given a score for each of these categories.
electronic equipment and low risk devices do The scores for each category are added up and a
not need performance verification at the same total score is given for each device type. Main-
frequency or intensity of higher risk devices. tenance strategies are determined based on
Medical equipment should be evaluated to the total score. A combined score of 13 or more
determine how often testing should be per- is justification for semiannual testing, a score
formed. If a device is not tested often enough, of 9-12 is justification for annual testing, and
it may fail before the next scheduled mainte- a score of 8 or less is justification for less than
nance or give erroneous results. If a device is annual testing, either bi-annual or no scheduled
tested too frequently, time that could be better testing, depending on clinical application. The
spent maintaining other equipment is wasted. result is a more cost-effective test program that
The biomedical professional’s job is to achieve a will result in improved patient care through less
balance between the time and effort needed for equipment downtime and more dollars for direct
periodic functional testing and the safe use patient care activities.
of medical equipment. The risks identified are used to assist in deter-
mining the strategies for maintenance, testing,
Risk-based inspection intervals and inspection of medical equipment. In addi-
tion, the identified risks are used to guide the
In order to maintain an efficient maintenance
development of training and education programs
program, the frequency of inspection must be
for staff that use or maintain equipment. All
determined. Effort should be spent on equip-
medical equipment is screened at the time of
ment where testing is likely to have an impact
delivery and appropriate training and testing
on the continued safe operation of the medical
of new equipment takes place prior to use on
device.
patients.

©University of Vermont, Rev. 2 – Confidential 5

 New device type
added to inventory

Complete
Maintenance
Strategy
Worksheet
The risk assessment should be done for
each new device type during the incoming
inspection when the device is added to the
inventory. The device will then have a test- Assign
ing frequency assigned. After this is done, inspection
frequency
the maintenance history of the device should
be monitored in order to evaluate the effec-
tiveness of the maintenance program. The
process is shown in Figure 1.
Inspection Accumulate Inspection
frequency may device frequency may
be too low history be too high

Evaluate
device
history

Yes

Frequent failures or
problems found
during testing?
Yes

No No

Infrequent failures
and no problems found
during testing?

No

Infrequent
failures, some minor
repairs or adjustments
needed during
testing?

Yes

Device has efficient

testing frequency

Figure 1.

6 ©University of Vermont, Rev. 2 – Confidential

 Maintenance strategy worksheet
Rating system for risk-based inspections University of Vermont Technical Services Program

Most device types have been evaluated and classified for test frequency already.
For new device types, use the scoring system to evaluate the frequency of testing.
Criteria: Choose one rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that 3
TSP testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1
There are requirements for testing independent of a numerical rating system 2
Total Score:
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested)
A combined score of 13 or more is justification for semiannual testing.
A combined score of 9-12 is justification for annual testing.
A combined score of 8 or less is justification for less than annual testing (either bi-annual or no scheduled testing, depending on clinical application).
Anesthesia machines and vaporizers are recommended for testing three times per year.
Some blood delivery devices such as warmers may be required to be tested four times per year based on AABB or CAP requirements.

Maintenance strategy assignment

Maintenance Program Check Ends Comment
Warranty: Attach coverage
Full manufacturers service contract
Manufacturers service contract with first look by TSP
CAPP contract with first look by TSP
TSP scheduled maintenance and repair
Hospital scheduled maintenance and repair
TSP repair on failure only
User maintenance only
Replace on failure only

Completed by:__________________________________________________________ Date:_ ____________________________________

©University of Vermont, Rev. 2 – Confidential 7

Clinical function is how invasive the equipment The last category is manufacturer’s or regu-
is to the patient. At the low end of this category latory requirements. This is also either yes or
is a device that does not make patient contact, no. If the device has a specific requirement for
for example, an exam light. The high end of this maintenance or testing, the device would score
category is a device used for life support, such high, otherwise the device would score low. The
as a ventilator. chart shown gives the scores from the main-
Physical risk is an evaluation of what will be tenance strategy worksheet for a few medical
the outcome if the device fails. At the low end devices.
is low risk; failure is more of an inconvenience To illustrate the application of the Mainte-
than actual harm such as an otoscope. Failure of nance Strategy Worksheet, two examples are
this type of device does not pose a threat to the given below, outlining the use of the worksheet.
patient’s outcome and the clinician can easily The first example is the pulse oximeter; the
use an alternate device with little impact to second is the electrosurgical unit.
patient care. At the high end is severe injury or The pulse oximeter is a device used for non-
death of the patient such as ventilator. Failure of invasive monitoring of blood oxygen levels. The
this type of equipment can have a serious detri- clinical function category would score 3 because
mental effect on the patient’s outcome. the device is used for direct patient monitoring.
Problem avoidance probability is based on Physical risk would score 3 because failure of
historic data related to medical equipment repair the device would cause inappropriate therapy,
and maintenance. The low end of this category perhaps not giving the patient supplemental
is maintenance or inspection having no impact oxygen, and/or loss of monitoring. Problem
on the reliability of the device; the high end is avoidance would score 2. Historically speaking,
common device failures are predictable and can failures of pulse oximeters are unpredictable and
be avoided by preventive maintenance. This impending problems are usually not uncovered
category also has an additional level, specific during periodic testing. Both incident history
regulatory or manufacturer’s requirements that and manufacturer/regulatory requirements score
dictate preventive maintenance or testing. 1. Historic data does not show a history of inci-
The device incident history is also based on dents involving pulse oximeters and there are no
historic data. This category only has two scores, specific requirements for maintenance of these
and is answered as yes or no. If a device had a devices. This gives the pulse oximeter a total
history of being involved in an incident resulting score of 10. Based in the maintenance work-
in patient harm, the device would score high. sheet, this is justification for annual testing.
Otherwise, the device would score low.

Problem Manufacturer
Clinical Physical Avoidance Incident or Regulatory Total Testing
Device Type Function Risk Probability History Requirements Score Frequency
Ventilator 5 4 4 2 2 17 Semiannual
Electrosurgical unit 4 4 2 2 1 13 Semiannual
Infusion pump 4 3 2 2 1 12 Annual
Pulse oximeter 3 3 2 1 1 10 Annual
Exam table 2 2 2 1 1 8 Bi-annual

8 ©University of Vermont, Rev. 2 – Confidential

 The electrosurgical unit is a device that uses Tracking device histories is useful for evaluating
high-frequency electric current for cutting or the effectiveness of the maintenance program. A
destroying tissue. The clinical function category computerized system is especially useful for this
would score 4 because the device is used for task, as different types of equipment problems
direct treatment of the patient. Physical risk will need to be tracked.
would score 4 because failure of the device Maintenance inspection intervals should be
could cause severe injury to the patient. Problem reviewed annually, to make changes as justified,
avoidance would score 2. Historically speaking, as well as following any changes in regulations
failures of electrosurgical units are unpredict- or guidelines. The review is done by analyz-
able and impending problems are usually not ing the data generated from the maintenance
uncovered during periodic testing. Incident history. To facilitate analysis, coding in the com-
history would score 2. Historical data reveals puterized maintenance management system on
that electrosurgical units have been involved the types of problems encountered is required.
with patient incidents. Manufacturer/regula- The University of Vermont uses a system where
tory requirements would score 1, as there are a work order is generated for every maintenance
no specific requirements for maintenance of event of a device. The work orders are coded
these devices. This gives the electrosurgical unit by type of maintenance event and the work
a total score of 13. Based in the maintenance order types categorize the service performed.
worksheet, this is justification for semiannual Work order types for maintenance, user errors,
testing. no problem found, recalls, upgrades, and other
As it can be seen from the previous exam- risk categories are tracked through the equip-
ples, devices that have more risk associated ment problem summaries. These summaries are
with them need more maintenance than other available for reporting to the Safety Commit-
devices. In the example, electrosurgical units tee to improve patient care and create a safe
will receive maintenance twice per year based environment.
on a risk assessment, while pulse oximeters will Devices that frequently have problems found
receive maintenance once per year. during the periodic performance inspection
One should note that devices were scored as or that have a high failure rate in between
generic device type only and are not model- inspections may need to have more frequent
specific. The risk criterion is used as a tool for inspections. Likewise, as the reliability of medi-
determining maintenance intervals. If a specific cal devices improves, fewer problems are found
model has testing or maintenance requirements during functional testing. In addition, newer
different from other devices of the same type, technology often requires fewer scheduled
the maintenance schedule can be adjusted on a parts for replacement as electronic controls are
case-by-case basis. replacing mechanical systems. For example,
anesthesia machines are beginning to use
Evaluating the effectiveness of the electronically-controlled flow controls instead of
maintenance program the traditionally used mechanical needle valve
Every maintenance program should be periodi- assemblies. Electronically controlled devices
cally evaluated for effectiveness. Performance tend to be more accurate and do not have parts
standards for medical equipment manage- that wear like mechanical systems do. These
ment should support the efforts of hospitals to devices may no longer continue to benefit from
manage health care technology for the purpose frequent inspections.
of improving the quality of care, containing the
cost of health care delivery, and improving the
safety of patients, hospital staff, and visitors.

©University of Vermont, Rev. 2 – Confidential 9

 In addition to tracking problems found during Performance standards should be clear and
functional testing, other types of device prob- reasonable, as well as ensure that local regula-
lems should be tracked. Device problems that tions are met. The most obvious example of a
cannot be reproduced and perceived problems performance standard is the functional test-
arising from incorrect use are indicators that ing completion rate. The University of Vermont
clinical staffs need additional education on the has found a realistic goal for the functional test
proper use of these devices. For example, if it is completion rate is 95 % of clinical devices with
noticed that there is a high incidence of work 100 % of life support devices. Other performance
orders with no problems found for patient moni- standards should be developed, such as the
tors, the clinical staff may need to be retrained number of use error related problems and dam-
on the proper operation of the monitors. Devices aged devices.
that have been abused may indicate the need If an evaluation finds the goals are not met, an
for additional staff education or a change in action plan should be developed to address the
clinical protocol such as equipment storage or problems. The underling cause of the problem
cleaning. Device failures that could have been must be discovered and then steps to solve the
prevented with proper maintenance, such as problem must be taken. After a plan has been
tubing and filters that need to be changed in a implemented, the plan should be monitored to
ventilator indicate that the maintenance sched- determine progress and evaluate whether or not
ule should be reevaluated or that additional the plan was effective.
technical education is needed.

10 ©University of Vermont, Rev. 2 – Confidential

CHAPTER 4: General procedures

Inventory control Location: This may be entered as the owner

Understanding what devices are in the facility in department or a physical location. The equip-
order to provide a quality maintenance program ment location is used to find the equipment
is critical. Inventory data is used for a variety of for maintenance. Also, the location is useful
applications including establishing a mainte- to break up the maintenance schedules by
nance schedule, tracking medical device hazards department.
and recalls, and deciding when to replace aging Maintenance history: A record should be
equipment. kept of all maintenance performed on equip-
ment, including scheduled maintenance, repairs,
Using a computerized medical software upgrades, and incident investigations.
equipment management system Dates of service should be included in this
history.
A computerized medical equipment manage- Work coding: For benchmarking and trend-
ment system is a useful tool in keeping track of ing, the type of maintenance being performed
the device inventory and maintenance his- on the equipment is required. The University of
tory. There are several programs commercially Vermont uses a work order coding system where
available, but whatever software is chosen, the a work order is generated for each maintenance
following information should be tracked. event and a work order type is assigned to each
Basic device information: Any medical work order. A sample of work order types are
equipment management software should track listed in the table on page 12.
basic device information. At a minimum, the Work order coding is important in measuring
device type, manufacturer, model, and serial the success of the maintenance program and
number should be tracked. This information is for identifying areas that need to be addressed.
essential to the maintenance program. For example, if there are a lot of work orders
Clinical use: The clinical use of a device indicating use error for a device, the trend may
should be documented. Equipment used for life indicate the clinical staff needs to be trained in
support needs to be given a higher priority for the proper use of the equipment. Below is an
maintenance. Additionally, regulations on life example of the use of trending data to identify
support devices may be different. In the United equipment with a high percentage of use error.
States, the Joint Commission requires equipment As a benchmark, equipment with a use error
used for life support to have a 100 % completion per device of greater than 10 % needs to be
rate for scheduled maintenance. addressed. In this example, hypo/hyperthermia
units have a use error percentage of around
12 %. Further investigation will need to be done
as to why the failures occur.

©University of Vermont, Rev. 2 – Confidential 11

Work order types for corrective maintenance
Work Order Type Definition
08-REPR-MAINT Device failure could have been prevented with maintenance, such as replacing tubing
09-REPR-RAND Device failure could not be prevented
10-REPR-USR ERR Device failure was caused by improper clinical use
11-REPR-DAMAGED Device failure was caused by abuse
12-REPR-NO PROB Reported failure could not be reproduced
14-RE-REPAIR Device failed for the same problem within 30 days of being repaired previously
18-TR-RAND B A minor problem found during the scheduled performance testing
19-TR-RAND C A major problem found during the scheduled performance testing
23-TR MAINT B A minor problem found during the scheduled performance inspection that could have been
prevented with maintenance
24-TR-MAINT C A major problem found during the scheduled performance inspection that could have been
prevented with maintenance
60-PLANNED Planned maintenance
57-NOT TESTED Device not tested during the regularly scheduled performance inspection
58-FT AFTER 57 Device that missed its regularly scheduled inspection has received a performance inspection
63-TR B - NFR A minor problem found during the scheduled performance testing that does not require follow up
64-TR C - NFR A major problem found during the scheduled performance testing that does not require follow up
65-TR A - NFR Scheduled maintenance (e.g. battery replacement) was not performed, no additional follow up is
necessary
Other work order types
15-INCOMING P Device passes initial performance inspection performed before the device is put into service
16-INCOMING F Device does not pass initial performance inspection
25-FT ADD P Device passes initial performance inspection performed after the device is already in service
26-FT ADD F Device does not pass initial performance inspection and has already been in service
27-FT NO ADD P Device passes initial performance inspection but will not be added to the inventory
28-FT NO ADD F Device that will not be added to the inventory does not pass initial performance inspection
30-PROD ALERT A recall or alert has been issued for a device
33-RECALL MOD Work done in answer to a recall, such as a software upgrade or parts replacement
37-INCIDENT INV Investigation of an incident involving the device
44-CALIBRATION Device requires calibration
59-INV DELETE Device is taken off of the inventory

12 ©University of Vermont, Rev. 2 – Confidential

Deciding which devices to put on the All major device classes should be assessed for
inventory inclusion based on function, risk, maintenance
The process to determine what devices will be requirements, historical incidents, and regula-
managed as part of the equipment management tions and each device type should be evaluated.
system is crucial to the success of the system. All Evaluations should be performed on new device
devices must be evaluated to determine if they types as they arrive at the hospital. All equip-
should be managed. ment used in the hospital should be evaluated
The University of Vermont uses three major regardless of ownership. Most commonly,
classifications of devices: clinical, utilities, and devices will fall into the clinical classification. A
general. Within the clinical classification, two maintenance schedule should be determined for
subgroups will be identified: life support and these devices based on the risk criteria dis-
non-life-support. Other equipment may be cussed in Chapter 3.
inventoried and tracked for financial or other Device inclusion must be performed and
reasons but is not included in this process. documented prior to any equipment use prefer-
Clinical equipment is any equipment used for ably during the technology planning stage prior
treatment, monitoring, or diagnosis of patients. to arrival at the facility. This process should be
Life support equipment is clinical equipment utilized for owned, rented, loaned, demonstra-
that takes over a function of the body and will tion or leased equipment.
cause immediate, within minutes, death if The factors must include function, risk, main-
removed. Under this definition a ventilator will tenance requirements, and history of incidents.
be considered life support equipment, whereas The University of Vermont has developed a
a hemodialysis machine is not considered life Device Inclusion Worksheet to facilitate this
support. Even though the hemodialysis machine process.
takes over the function of the kidney, removal
of the patient from hemodialysis will not cause
immediate death.

User Error and No Problem Found Work Orders By Device Type

(Excludes Devices With Inventory Count <15)
% Errors Per Device Type Per Quarter

13.00 %
12.00 %
11.00 %
10.00 %
9.00 %
8.00 %
7.00 %
6.00 %
5.00 %
4.00 %
3.00 %
2.00 %
1.00 %
0.00 %
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El
In

m
n
po

ar

Pu
tio
W
Hy

ta
lS
ra
nt
Ce

Figure 2.

©University of Vermont, Rev. 2 – Confidential 13

 Device inclusion worksheet

Device information
Device type Owner Hosp Vendor MD Other
Manufacturer Department
Model Tester Hosp TSP Mfr User
Serial number Prev maint Hosp TSP Mfr User
Control number Tests/year 1x 2x 3x 4x

Inclusion assessment
The intent is to capture all powered devices that by function, physical risk, maintenance requirements, or a history
of incidents or safety problems should be managed as a part of the medical equipment management system. Some
devices have a borderline inclusion between medical equipment and utilities, so tests for inclusion in the utilities
management program are included.
1: Life support equipment
Would failure of this device result in immediate death of the patient? And Yes No
Is the powered device used for direct patient treatment or care? Yes No
An answer of “Yes” to both of the above questions indicates that the device should be managed in the medical equipment inventory as a life support device.
2: Medical equipment
Is the powered device used for direct patient treatment or care? Yes No
Does the powered device provide diagnostic/monitoring information used in treatment? Yes No
Does this powered device come in contact with the patient? Yes No
An answer of “Yes” to any of the above three questions indicates that the device should be included in the medical equipment management program and
be inventoried under those provisions.
3: Utilities equipment
Does this device facilitate life support functions? Yes No
Does this device support infection control systems? Yes No
Does this device support facility environmental systems? Yes No
Does this device support critical facility utility systems? Yes No
Does this device support essential communications systems? Yes No
If the device fails to meet the medical equipment requirements, but there are any “Yes” answers to the utilities equipment questions, the device should be included
in the utilities equipment management program.
4: Clinical and physical risk
Does the device pose risk to the patient or staff when used in the facility? Yes No
Would failure or loss of use of the device adversely affect the deliver of health care? Yes No
Does this product or class of device have a history of incidents or safety recalls? Yes No
5: Maintenance requirements
Does the device require periodic inspection in order to ensure safe delivery of care? Yes No
Does the device require periodic performance testing to ensure safe delivery of care? Yes No
Does the device require periodic preventive care to ensure safe delivery of care? Yes No
If the device fails to meet the requirements for Medical or Utilities Equipment, but there are “YES” answers to the above questions in Clinical and Physical risk or
Maintenance Requirements, the device should be managed on a general equipment inventory with preventive maintenance or testing as appropriate.
Management program assignment
This device will be assigned as Life Support Equipment Yes No
This device will be assigned as Medical Equipment Yes No
This device will be assigned as Utilities Equipment Yes No
This device will be assigned as General Equipment Yes No
This device will be NOT be included in any equipment management program Yes No

Completed by:__________________________________________________________ Date:_ ____________________________________

14 ©University of Vermont, Rev. 2 – Confidential

Incoming inspections Incoming inspection of temporary
The initial test for a new piece of equipment medical equipment
prior to the use in patient care is called the Temporary medical equipment is equipment
Incoming Inspection. This inspection serves to that is not owned by the hospital, and which is
ensure the equipment passes all performance either used for patient care on a sporadic basis,
and safety requirements prior to use. This is or which will be used for a limited amount of
typically the most rigorous test performed of all time at the facility, typically 90 days or less.
inspections. A test form should be used to docu- Such equipment may include rental equipment,
ment test results. Incoming inspections should a sales demo, or patient owned equipment.
be done on all medical equipment, regardless of Temporary medical equipment needs to be
whether owned, rented, leased, loaned, or on properly maintained just as hospital owned
demonstration equipment. equipment does to protect the safety of the
Each device should be evaluated per the patient.
Device Inclusion Worksheet to determine the All medical equipment needs to undergo an
inventory classification. All medical equipment incoming inspection. Medical equipment that
determined to be on a management program will be at the facility for a single time of 90 days
needs to receive a performance and safety test or less does not need to be added to the equip-
prior to patient use. Working with clinical staff ment inventory, although a record should be
is required to ensure all medical equipment kept of the initial incoming inspection. Equip-
receives an incoming inspection, including demo ment that will be at the facility for longer than
equipment brought in by vendors. 90 days should be added to the equipment
If the equipment passes the inspection, the inventory to be tracked just like hospital-owned
device should be entered into the hospital’s equipment.
inventory. Inspection labels, warranty labels, Equipment that will be brought repeatedly to
and battery labels are also placed on the device the facility, such as a rental device, will need to
when appropriate. The equipment can now be have an incoming inspection and be added to
placed into service. the inventory. Additionally, the vendor should be
If the device does not pass the inspection, it required to certify that each time the device is
is not placed into service and the deficiencies brought to the facility, the equipment has been
are noted. Many devices receiving an incoming maintained, and that the device is safe and
inspection are covered under warranty. In this ready for use. The University of Vermont uses
case, the vendor should be contacted to either the following Vendor Safety Certification Form to
exchange or repair the equipment. The equip- ensure these devices are safe and ready for use
ment should not be placed into service until it when they are brought into the facility.
can successfully pass the incoming inspection.

©University of Vermont, Rev. 2 – Confidential 15

Vendor Safety Certification Form used clinically. As a prerequisite to patient use of
Medical equipment often is provided to facili- devices that cannot be fully tested by the hos-
ties for use as loaners, demonstration, rental pital, the hospital requires the vendor to provide
or lease. It is sometimes not possible for the a certification that the device(s) is/are safe for
hospital or its biomedical equipment agent to use at the facility for a specific period of time or
adequately test these devices before they are under specific circumstances of use.

Clinical Use Prohibited Without This Certification

Hospital:________________________________________________________________________________

Department:____________________________________________________________________________

Manager:________________________________________________ Date:_________________________

Device Description:_ _____________________________________________________________________

Vendor:__________________________________________________ Contact:_ _____________________

Serial Numbers of All Devices:_____________________________________________________________

Intended Use of the Device:_______________________________________________________________

Dates of Use: Start:________________________________________ Stop:_________________________

Vendor completes this part:

����� This vendor certifies this device is provided to the facility in safe and useable condition, and is FDA
approved for the intended clinical procedure(s). This vendor has or will test the device for proper
function prior to clinical use, but after arrival at the facility. Training will be provided to staff on
safe use and potential risks.
����� This device is an investigational device for which FDA approval does not exist as of yet. The device
will not be used clinically until all hospital investigational review board approval is received.
Training will be provided on safe use and potential risks.
����� This equipment is provided repeatedly to the hospital and is maintained by the vendor. It is
checked between assignments to different facilities, and records of maintenance are provided
annually to the facility. Ongoing performance and safety testing is provided, and the vendor
certifies that the device is safe for use as provided at delivery.
����� Non-hospital employees who will be delivering and/or operating the equipment are appropriately
trained and qualified to be transporting, setting up, and operating the equipment.

Note any special conditions:_ _____________________________________________________________

_______________________________________________________________________________________

Vendor Signature:_ ______________________________________ Date:_________________________

Facility Signature:_______________________________________ Date:_________________________

16 ©University of Vermont, Rev. 2 – Confidential

Documentation most commonly because the equipment could
Documentation is very important to any main- not be physically located. The equipment may
tenance program. Tracking what maintenance also miss an inspection if it is being used on a
has been performed is impossible if there is no patient and cannot be removed or if the equip-
documentation. All maintenance, scheduled and ment has been sent out for repair.
unscheduled, should be recorded in the equip- Every effort should be made to locate and
ment history. inspect equipment marked as ‘Not Tested’
The University of Vermont uses documentation and working with clinical staff to locate this
by exception to report the results of scheduled equipment will be required. A list of missing
performance inspections. Documentation by equipment should be sent to the department so
exception is the process of documenting fail- that the staff can keep watch for the missing
ures only. A work order is completed only for equipment. A protocol should be established
those devices that fail to meet a routine, sched- for clinical staff when they find the equipment.
uled inspection against safety, performance or If possible, the equipment should be set aside
quality assurance criteria. Devices that pass for testing. Designating a storage area for this
the scheduled inspection criteria are rendered purpose is desired.
acceptable and do not require written test forms At the University of Vermont, a work order is
or additional work orders. created for devices that were not tested during
All incoming inspections, other additions to their scheduled test round. The work order is
inventory, and devices that have undergone left open for up to thirty days while biomedi-
corrective maintenance should have a docu- cal equipment technicians attempt to locate
mented PM/inspection form and work order the equipment. During this time, nursing staff
completed. is asked to assist in locating the equipment. A
notice is sent to the department manager with
Locating missing equipment a list of equipment that needs to be located for
inspection. If nursing staff locates the missing
As stated above, the University of Vermont uses equipment, the equipment is set aside, if pos-
a system of documentation by exception. A sible, until it can be inspected and biomedical
work order needs to be opened for each prob- personnel are notified.
lem noted during the scheduled test round. Once the equipment has been inspected,
The work order coding system contains specific another work order is created to show that the
work order types for problems encountered equipment received its scheduled maintenance.
during scheduled maintenance. This work order has a type that indicates a
One work order type ‘Not Tested’ is par- functional test following a ‘Not Tested’ work
ticularly useful. This work order type is used order. Again, the coding system is important, as
to mark equipment that did not receive its it allows these types of maintenance events to
scheduled inspection. Equipment may miss its be identified.
scheduled inspection for a variety of reasons,

©University of Vermont, Rev. 2 – Confidential 17

Labels
Labels are an easy and effective way to com- RVICES RVICES RVICES
SE SE SE
municate information about medical equipment. DATE DUE DATE DUE DATE DUE

HNICAL

HNICAL
HNICAL
PR

PR
PR
The University of Vermont uses a variety of

O G RA

O G RA
O G RA
TESTED BY TESTED BY TESTED BY
labels to indicate specific data necessary for

EC

EC
EC
B -ANNUAL ANNUAL SEMI ANNUAL
technology management, regulatory require-

M
M
T T
• U • U
T
VM • • U VM •
ments, and for safety. Labels may be used for VM •
performance inspections—bi-annual, annual,
semiannual and general, battery installa-
tion, specific calibration, warranty, hazards RVICES RVICES
SE SE
and warnings, and upgrade or recall data. In DATE DUE

HNICAL

HNICAL
DA E DUE

PR

PR
addition, a unique identifier control number is

O G RA

O G RA
TESTED BY
ES ED BY
placed on each piece of equipment for ease of

EC

EC
QUARTERLY

M
T T
device tracking. The following are examples of • U • U
VM • VM •
these labels:
Control number tags are made of aluminum
and attached with a permanent adhesive. Biomedical Engineering Dept
PERFORMANCE TESTED BY
These tags need to be rugged in order to stand TECHNICAL SERVICES PROGRAM ELECTRICAL SAFETY TEST
up to repeated cleaning and disinfecting of the Name________________ Date__________
Completed by__________________________
Date__________________________________
equipment. Other labels are made of a material Inspection Due_________________________
UAL BE269
that allows them to be peeled off and replaced.
Labels that require written information should
be filled in using permanent marker, to avoid
fading of the ink. NON-HOSPITAL OWNED BATTERY REPLACED
EQUIPMENT Date____________ By____________
Date Due_______________________
Electrical Safety Tested
Biomedical Engineering Dept
Date______________ By_____________ BE702
Next Inspection Due_____________________

TSP-UVM ANESTHESIA This equipment is

VAPORIZER PROGRAM under warranty.
OUTPUT VERIFICATION Beginning__________ Ending__________
DONE___________ DUE________ BY________ UAL BE282
OVERHAUL/REMANUFACTURER
DONE_______________ DUE_______________
Inspection labels that include a next inspec-
tion due date are especially useful. Clinical staff
should be trained that if they find a piece of
CENTRIFUGE PERFORMANCE TEST
equipment with an outdated inspection sticker,
they should put the equipment aside if possible
Setting Cent Tach Photo Tach
RPM DEFECTIVE
and contact biomedical personnel.
RPM
RPM
DO NOT USE
Care should be taken to ensure labels are MAX RPM
Timer Stopwatch DATE: ____________________
not placed over important information, such as Date By
BY: ______________________
warnings, contraindications, and instructions. Due Control #
UAL BE305
DO NOT REMOVE
THIS LABEL
BE203

Figure 3. Label samples.

18 ©University of Vermont, Rev. 2 – Confidential

Forms The checklist has an option for each main-
Testing checklists should be developed for each tenance task as either passed, failed, or not
device type. These lists are useful because they applicable. Devices that have maintenance
outline recommended maintenance procedures tasks that fail should not be put back into ser-
and provide numerical criteria for quantitative vice until the problem has been corrected.
tests. The not-applicable category is necessary
The maintenance checklists should be filled as the maintenance checklists are generic by
out during an incoming inspection or testing device type and, since device operation varies
following a repair. The University of Vermont from model to model, not every maintenance
uses documentation by exception policy and task can be performed on every device. For
does not fill out a maintenance checklist for the example, the centrifuge maintenance checklist
successful completion of a scheduled perfor- includes timer accuracy, operation of the brake,
mance inspection. Maintenance forms can be and alarm activation. High-end centrifuges will
either paper or electronic format. Placing main- have all of these functions. However, simpler
tenance checklists on a handheld device such centrifuges may not have these functions to be
as a PDA that can be filled out electronically tested. This doesn’t mean the device is unsafe
may be useful. to use, it simply means the equipment does not
The maintenance forms should contain infor- have those functions.
mation on what equipment is being inspected, Every maintenance task that needs to be
the date the inspection occurs, and who is to performed on every device can be included on
perform the inspection. A list of maintenance the maintenance checklist. Device function and
tasks should be broken down by subsystem operation vary greatly by model and manu-
and numerical criteria given for quantitative facturer. Reference to the equipment’s service
tests. For example, the measured flow rate of an manual for any additional maintenance tasks is
infusion pump should be within 10 % of the set required. A sample form for Infusion Pumps is
rate. This criterion appears on the test form next shown on page 20.
to the task for flow rate accuracy.

©University of Vermont, Rev. 2 – Confidential 19

 Infusion pump procedure
Estimated time: 45 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer 20 cc or larger syringe
IDA4 Plus Infusion Device Analyzer 3 way stopcock
Tubing set for infusion pump Tubing and connectors to connect to IDA 4 Plus
Reservoir to connect to tubing set (bag or bottle)

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean flow detector
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Pole clamp function
Flow rate accuracy ± 10 %
Volume accuracy ± 10 %
Infusion complete/KVO
Occlusion detection pressure ± 1 psi
Piggyback infusion
Alarm function
Complete model-specific performance testing

20 ©University of Vermont, Rev. 2 – Confidential

Safety In order to service equipment, removing
Maintaining and inspecting medical equipment the cover is necessary. This will expose more
involves a number of risks, including electrical electrical hazards. Jewelry, such as rings and
and mechanical hazards. Many maintenance watches, should be removed to avoid acciden-
tasks include precautions to minimize theses tal contact with electrical components. Power
risks. Always follow manufacturer’s guidelines should be removed from the equipment during
for safety precautions during specific tests. the repair process whenever possible. As many
Being aware of potential hazards will allow tests as possible should be performed without
risks to be minimized. power to the equipment, for example, using an
Electrical hazards: Electricity poses a ohmmeter to check semiconductors for a short
significant hazard for biomedical personnel. circuit. If you must test a live circuit, be care-
Not only are you exposed to electrical hazards ful not to accidentally cause a short with your
during a repair, but also while testing medical test leads, as this can cause damage to compo-
equipment for electrical safety. Electrical safety nents. Also be aware that capacitors can store
testing requires the simulation of faults and a charge even after the equipment has been
extra caution should be taken. unplugged for some time.
Electrical safety testing should be done before If a circuit board needs to be moved from
performance testing. The continuity between their mountings, insulating material should be
the chassis and the ground pin on the plug placed between the board and anything that
should be confirmed first; this is the primary may cause a short. Adjustments to potentiom-
protection against electrical shock to equipment eters should be made with insulated tools.
users. Check the power cord for frayed instal- Use caution while handling static sensitive
lation or exposed wires. Damaged power cords components, as even small amounts of static
should be replaced immediately. electricity can cause damage to the compo-
Testing should never be performed on equip- nents. Use an anti-static wrist strap to avoid
ment that is in use on a patient. As stated damage to sensitive components.
above, electrical safety testing simulates Mechanical hazards: Mechanical and
electrical faults and can expose the patient to pneumatic assemblies pose hazards as well and
dangerous voltages and currents. Work with should be given appropriate caution. Moving
clinical staff is necessary to either disconnect parts can cause injuries such as cuts and
the equipment from the patient or to arrange crushed fingers. Unsecured fittings on pneu-
a time to test the equipment when it is not matic systems can blow off under pressure and
in use. The electrical safety analyzer should become projectiles. Compressed gases also pose
be plugged into a properly grounded outlet to fire, as well as suffocation hazards.
prevent a shock hazard while testing a piece of When inspecting equipment with moving
defective equipment. parts, for example, irrigation units and elec-
Line voltage is used during lead isolation tric beds, fingers, and clothing should be kept
testing. This test should only be performed with away from the moving parts. Maintenance such
test equipment that has been designed for safe as visually inspecting for wear, cleaning, and
application of the voltage to the patient leads. lubrication should be done with the equipment
Do not touch the leads during lead isolation powered off, and unplugged if possible. Jewelry
testing, as this may cause a shock. should be removed to avoid getting caught on
moving parts and loose clothing, such as ties,
should be secured.

©University of Vermont, Rev. 2 – Confidential 21

 Compressed gas cylinders pose unique haz- Food and drinks should be kept away from
ards and should be handled carefully. Oxidizing benches, shelves, and other areas where poten-
gases such as oxygen and nitrous oxide pose a tially contaminated medical equipment is being
serious fire hazard. Additionally, gases such as serviced or stored. Applying cosmetics and
nitrogen, nitrous oxide, and carbon dioxide are handling contact lenses should also be avoided
a suffocation hazard in large amounts. in these areas.
Damage to the cylinder valve can have Equipment should only be inspected or
catastrophic effects. The cylinder will rapidly repaired after it has been disinfected. Clinical
discharge its contents, possibly causing a staff should be educated on the proper way to
suffocation or fire hazard and as the cylin- disinfect equipment and what type of disin-
der discharges, will become a projectile. Care fectant to use. Certain disinfectants can cause
should be taken to never drop a gas cylinder. If damage to equipment such as breaking down
a cylinder for a piece of equipment is removed, the plastics used for the outer case and caus-
the cylinder should be laid down on the floor. A ing the case to become brittle. Check with the
cylinder standing on end is easily knocked over. equipment’s user manual or the manufacturer
Do not drag, roll, or slide cylinders, as this can for instructions on how to disinfect equipment
damage the valve. and what disinfectants can be used safely.
Combustible substances such as oil and If work must be done on equipment that has
grease should not be used with compressed not been cleaned, wear personal protective
gas. Likewise, you should not handle cylinders, equipment such as gloves, mask, and gown.
hoses, regulators, or other gas system compo- Disinfect the work area when done and wash
nents with oily hands or gloves. Oxidizing gases hands thoroughly after removing the protective
such as oxygen and nitrous oxide will ignite equipment.
violently when combined with a heat source, The Blood borne Pathogen Standard became
such as an electrical spark or even frictional a federal regulation in the United States
heat caused by gas moving through narrow enforced by the Occupational Health and Safety
hoses, and a combustible fuel. Administration (OSHA) on March 6, 1992. The
Make sure connections to high pressure sys- purpose of the regulation is to limit occupa-
tems are secure. High pressure gas can cause tional exposure to blood and other potentially
connectors to become projectiles. To avoid infectious materials. The focus of the mandate
connectors from suddenly disconnecting, use is to utilize universal precautions and work
threaded or positive locking connectors. Do not practice controls to reduce the exposure risk
use friction fittings, as they will not stand up to to HIV, hepatitis and other infectious diseases.
a high pressure. Biomedical equipment technicians are specifi-
Infection control: Another risk inherent to cally mentioned as an at-risk group due to their
maintaining medical equipment is biological work on medical equipment that may be con-
hazards. Infection control guidelines need to be taminated. The regulation states: “Equipment
followed in order to prevent both contracting which may become contaminated with blood
diseases and to avoid the spread of nosoco- or other potentially infectious materials shall
mial infections. The easiest and most effective be examined prior to servicing or shipping,
method to prevent the spread of infection is and shall be decontaminated as necessary”
with proper hand washing. Hand washing (Paragraph (d)(2)(xiv). The only exception in the
should be performed before eating, after standard is if decontamination of the equipment
handling soiled equipment, after removal of is not feasible. In this case, a biohazard label,
gloves, after the end of a shift before you leave and a description of the contamination must be
the facility, and any time hands are obviously placed on the device.
soiled.

22 ©University of Vermont, Rev. 2 – Confidential

 At the University of Vermont, all staff with Cleaning equipment
occupational exposure to blood borne patho- Medical equipment needs to be cleaned to
gens, BBP, receive initial training before prevent the spread of inspections and also to
exposure to the BBP environment and annual keep the equipment in operational condition.
refresher training. The hepatitis B vaccine is For example, residue from adhesive tape can
provided to staff upon completion of the initial make displays difficult to read. The manufac-
BBP training. Universal precautions, a method turer’s cleaning procedures in the equipment’s
of infection control in which all blood and body operation manual should always be followed to
fluids are treated as if known to be infectious prevent damage caused by cleaning.
for HIV, HBV and other blood borne pathogens, Some cleaners may damage equipment. The
and engineering/work practice controls are University of Vermont has found problems
used to limit occupational exposure to blood associated with cleaning solutions, including
and other potentially infectious materials. cracked and brittle cases on equipment and
Tuberculosis is a serious bacterial infection degradation of panel membranes. In this case,
that can spread from individual to individual work order trending revealed a high percentage
through the air and may scar lungs, kidneys, of ‘damaged’ work orders for infusion pumps.
bones, or the brain. Tuberculosis is highly Upon further investigation, it was found that the
contagious and can be fatal, though it is usually cleaning solution that was being used to disin-
curable with medication. fect the pumps between patients was causing
At the University of Vermont, every staff the plastic cases to turn brittle and crack.
member who performs work in a healthcare is Working with the manufacturer of the pumps,
tested using the PPD Mantoux skin test prior to a recommendation for a suitable disinfectant
work in the environment, with clinical follow was made.
up is required for a positive test result. Staff are Always check the equipment operation
tested annually thereafter for the presence of manual in the proper way to disinfect the
the TB virus. equipment. The manual should list the pre-
ferred cleaning method and what cleaners
Storage can be used. Also be aware that cleaners can
Equipment that is not used every day is often sometimes discolor, etch, or soften materials
put into a storage room. Equipment should be such as plastics often used in equipment cases.
cleaned before being put into storage. Equip- Always test cleaners in an inconspicuous area
ment that has a battery should be stored before using.
plugged in to keep a charge on the battery.
Equipment in active storage will need to
have scheduled maintenance like other equip-
ment, even if it has not been used since the last
performance inspection. Regularly scheduled
performance inspections Ensure the equipment
is safe and ready for use.

©University of Vermont, Rev. 2 – Confidential 23

 CHAPTER 5: Electrical safety

Electrical safety is an area of concern related to cause ventricular fibrillation in experiments

medical devices. Electrical shock can cause dis- conducted with dogs when a conductor made
ruptions during healthcare procedures, injury, direct contact to the heart. Microshock is the
and death. Physiological effects range from a term used to describe direct shocks to the car-
tingling sensation to serious burns and electro- diac muscle.
cution. Excitable human tissue is very sensitive From the data for macroshock and micro-
to current in the frequency range of electrical shock, limits have been established for leakage
power systems worldwide—50-50 Hertz. Figure current. These limits are contained in various
4 shows the effects of current flowing from one standards worldwide. In the case of equipment
skin contact point to another. Macroshock is the designed for low resistance, direct contact with
term applied when electrical current is applied patients including indwelling catheters, elec-
externally. trical isolation design techniques are applied
The electrical safety issue takes on added to reduce the current flowing to the patient to
significance related to electrically-susceptible microamperes even at line voltage levels. Even
patients. For cardiac procedures, electrically under device failure or short circuit conditions,
conductive catheters may be placed into the the patient is protected from microshock. These
heart while the patient is connected to medi- techniques may utilize isolation transformers
cal equipment. The skin is a high electrical and optical circuits. Thus, electrical safety stan-
resistance, but internal body components such dards specify low microampere limits for direct
as blood and muscle are a low electrical resis- patient contact equipment.
tance. Currents as low as 20 microamps can

Burns

Cardiac fibrillation

Muscle contraction, suffocation

Let-go current

Sensitivity limit

1 mA 10 mA 100 mA 1A 10 A 100 A

Figure 4. Effects of current flowing from one skin contact point to another.

24 ©University of Vermont, Rev. 2 – Confidential

 To reduce leakage current to negligible levels, The basic electrical safety tests are:
chassis grounding is utilized to shunt any leak- 1. Visual inspection of cables, plugs and
age or fault current to ground—not to the patient connectors
or staff. Figure 5 shows pictorially and sche- 2. Measurement of ground wire resistance
matically the hazard current from the electrical 3. Measurement of chassis and patient lead/
failure being safety shunted to ground through contact isolation
this alternative pathway. Effective grounding Other tests may be required depending upon
can only be achieved with very low resistance the country, state/province/department, or
pathways to ground on the order of tenths of an local codes.
ohm. Grounding is another measurement speci-
fied in electrical safety standards for medical
devices.

230 V
50 Hz

Fuses 230 V

10 Ω
~22 A

~11 V

0.5 Ω 0.5 to 200 kΩ

~22 A .055 to 22 mA

Figure 5. Hazard current from electrical failure being safety shunted to ground through an
alternative pathway.

©University of Vermont, Rev. 2 – Confidential 25

Electrical safety standards The terminology used in IEC 60601.1 includes
Electrical safety standards have been developed • Protective earth resistance
in the United States, European countries, and • Earth leakage current
other parts of the world. The standards differ in • Enclosure leakage current
criteria, measurements, and protocol. • Patient leakage current
The International Organization for Stan- • Patient auxiliary current
dardization (ISO) and the International • Mains on applied part (MAP)
Electrotechnical Commission (IEC) based in To represent the impedance of a patient, the
Europe are organizations that provide standards test load in Figure 6 has been developed.
worldwide in partnership with the World Trade Leakage current measuring devices use this
Organization. These standards include those impedance circuit for measurements.
for electromedical equipment. There are gen-
eral and specific standards for medical device
electrical safety. 10,000 Ω
The primary standard for medical devices
has been IEC 60601. General requirements for 0.015 µF
protection against electric shock hazards are Milli-
covered in IEC 60601.1, Section 3. Input 1,000 Ω voltmeter
In this standard, each instrument
has a class.
• Class I – Live part covered by basic Figure 6. Impedance of a patient test load.
insulation and protective earth
• Class II – Live part covered by
double or reinforced insulation Leakage measurements (IEC 60601.1, Sec-
• Class IP – Internal power supply tion 3, Clause 19 limits have been developed
Each patient applied part or patient for equipment types and measurements. NC
lead has a type. is normal conditions and SFC is single fault
• Type B – Patient applied part conditions. Some of the measurements are only
earthed applicable to manufacturer design testing.
• Type BF – Patient applied part
floating (surface conductor)
• Type CF – Patient applied part
floating for use in direct contact
with the heart

26 ©University of Vermont, Rev. 2 – Confidential

 Earth Enclosure Patient Patient Patient leakage Patient Patient Patient
leakage leakage leakage leakage current mains auxiliary auxiliary auxiliary
Leakage current current current AC current DC on applied current current DC current AC
current (µA) mA (µA) (µA) (µA) (µA) (µA) (µA) (µA)
Type B NC 5 100 100 10 — 100 10 100
SFC 10 500 500 50 — 500 50 500
Type BF NC 5 100 100 10 — 100 10 100
SFC 10 500 500 50 5000 500 50 500
Type CF NC 5 100 10 10 — 10 10 10
SFC 10 500 50 50 50 50 50 50

Other important points about IEC 60601.1 2. Association for the Advancement of Medi-
are the use of up to 25 amperes AC for protec- cal Instrumentation (AAMI) - ANSI/AAMI
tive earth testing, leakage current is measured ES1, Safe Current Limits for Electromedical
at 110 % of mains voltage, and performance of Apparatus is another commonly accepted
dielectric strength/insulation testing. standard.
A new IEC standard is used for medical 3. Underwriters Laboratories (UL) - UL544,
device testing in hospitals. IEC standards 62353 Medical Equipment requirements is a stan-
applies to testing of medical equipment and dard for manufacturers, not hospitals.
medical electrical systems, which comply with These standards may be referenced by accredi-
IEC 60601-1. IEC 62353 was developed because tation, code or regulatory organizations such as
IEC 60601.1 is a type-testing standard with no the Joint Commission, Occupational Health and
risk management criteria and is impractical for Safety Administration or other organizations
testing in the hospital environment. monitoring healthcare institutions in the United
IEC 62353 tests include those prior to use on States. The Appendices describe the above
patients, during schedule periodic testing, and standards and test setups.
after repair. Thus, this standard is for hospi- Global harmonization of standards has lead to
tals and does not address equipment design. the development of world wide standards. After
In Annex E of the document, the manufacturer the deadlines below, equipment must be certi-
is requested to provide information on testing fied to the IEC60601-1 standard or the device
interval and procedure based on risk, typical cannot be sold in that country.
usage, and device history. Minimum interval
• USA uses UL2601-1
requirements for life support and other critical
– The deadline was December 31, 2004
equipment is set at 24 months.
• Europe uses EN60601-1
In the United States, there are several primary
– The deadline was June 13, 1998
and secondary organizations setting standards:
• Canada uses CAN/CSA-C22.2 No. 601.1-M90
1. National Fire Protection Association
– The deadline was January 1, 2000
(NFPA) - NFPA 99, Standard for Healthcare
Facilities is the primary standard addressing
electrical safety testing affecting healthcare
institutions. Other publications are NFPA 70,
National Electrical Code, and NFPA 70E,
Electrical Safety in the Workplace.

©University of Vermont, Rev. 2 – Confidential 27

Electrical safety testing
Testing requirements and sequence Start
according to IEC 62353 Annex C are
shown below. Only measurement
Selection of the test Insulation resistance
equipment that meets IEC 61010-1 see 4.1 see 5.3.3
should be used.
The sequence outlined in Figure Visual inspection Functional test
7 should be followed. For example, see 5.2 see 5.4
protective earth resistance should
be measured prior to leakage cur- Protective earth resistance Reporting of results
see 5.3.1 see 5.1
rent measurements.
Leakage current Evaluation
see 5.3.2 see 5.2

Check and prepare

for normal use see 5.2

Figure 7. Testing requirements and sequence according to IEC 62353 Annex C.

General connections to an electrical safety • Tests and measurements

analyzer (ESA) are shown in Figure 8. Consult • Date, type, and outcome/results of
the operational manual for specifics for your ESA. – Visual inspections
Documentation requirements for IEC 62353 – Measurements (measured values,
include: measuring method, measuring equipment)
• Identification of the testing group (hospital – Functional testing according to 5.4
department, independent service organiza- • Concluding evaluation
tion, manufacturer) • Date and signature of the individual who
• Names of the persons, who performed the performed the evaluation
testing and evaluation(s) Computerized record-keeping systems are
• Identification of the equipment/system (e.g. greatly preferred for data storage, search,
type, serial number, inventory number) and review, and analysis. Note the device fields
the accessories tested must be standardized.

To protective
earth or
N
R
enclosure
S
Pro ON
01 RN
N

2
5
8

0
3
6

Figure 8. General connections to an electrical safety analyzer.

28 ©University of Vermont, Rev. 2 – Confidential

 Electrical safety procedure
Estimated time: 5 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: Fluke Biomedical ESA620 or equivalent

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Fuse rating is appropriate
Power cord, accessory cables, charger, patient cables, connectors
Integrity of mechanical parts
Electrical safety Criteria IEC 62353
Ground wire resistance 0.3 W
Current in µA Applied part
Type Type Type
B BF CF
Equipment leakage – alternative method
For accessible conductive parts of Class I equipment con-
1000 1000 1000
nected or not connected to the protective earth conductor
For Class II ME equipment 500 500 500
Equipment leakage – direct or different method
Equipment leakage current for accessible conductive parts
of Class I ME equipment connected or not connected to the 500 500 500
protective earth conductor
Equipment Leakage current for Class II ME equipment (NC) 100 100 100
Applied part leakage current – alternative method (a.c.)
Applied part leakage current of applied part — < 5000 < 50
Applied part leakage current – direct method (a.c.)
Total patient leakage current mains voltage on applied part — 5000 100
Insulation test (optional) 500 V dc applied < 2 MW

Tested by:_ ________________________________________ Date:_______________________________________________

©University of Vermont, Rev. 2 – Confidential 29

 To grounded portion
of enclosure

Figure 9. ESA601 connected to a device under test.

Physical condition
Verify the case integrity and look for damage.
Ensure the device is not contaminated. Check
the controls, indicators, and displays. Verify
the labeling is appropriate, not damaged and
legible. Check the fuse has the proper rating.
Visually inspect the power cord, plug, any
cables, connectors, chargers, or other external
connections. Verify any mechanical parts are in
good condition.

Electrical safety analyzer (ESA) setup

Place controls in startup mode (e.g. ESA 620
function switch to OFF). Insert measurement
cables into the ESA. Plug the ESA into the
power receptacle and turn on. Ensure the line
voltage is appropriate as read from the ESA.
Note: All tests below should be performed with the device
OFF and ON. The highest reading should be documented or
used for exception reporting. Typical electrical safety test set-up.

30 ©University of Vermont, Rev. 2 – Confidential

 DEVICE UNDER TEST
S5 DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
S1 S2

EARTH
OPEN GREEN
TERMINAL DUT_PE FE

PE S3

CONDUCTIVE PART

_ TEST LEAD

CURRENT
SOURCE OHM
1 A DC

+ RED TERMINAL

Figure 10. Protective earth resistance test configuration.

Switch Ground wire resistance

Diagram Reference ESA601 Name Action Insert the medical equipment electrical power
S1 Neutral — plug into the ESA power receptacle. If this is a
S2 Polarity — permanently-wired device, a ground connec-
S3 Earth Open tion at the same potential as the device under
S5 — — test needs to be located. A ground wire must be
attached to the ESA ground input. Devices that
are located in rooms with isolated power should
be tested on grounded distribution systems.
Zero the test lead resistance by connecting
the RED lead to the ESA ground point (e.g.
ESA 601—PE TEST POINT) and pressing the
Zero button.
Attach the RED ground lead to the device
under test (DUT) chassis grounding point.
Activate the control for ground wire resistance
measurement and record the reading or docu-
ment by exception only.

©University of Vermont, Rev. 2 – Confidential 31

 DEVICE UNDER TEST
DUT_L1

APPLIED
PART

+ DUT_L2
500 V
_ DC
MD
MEG
OHMS
DUT_PE
FE

EARTH
OPEN
CONDUCTIVE PART

S3

PE

Figure 11. Mains insulatioin resistance test configuration.

Insulation tests Switch

Remove the red test lead from the chassis Diagram Reference ESA601 Name Action
grounding point. Switch the function switch to S3 Earth Open
measure insulation first from earth ground, then
from the patient applied part.

32 ©University of Vermont, Rev. 2 – Confidential

 DEVICE UNDER TEST
S5 DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
S1 S2

EARTH
OPEN
DUT_PE
FE

S3

CONDUCTIVE PART
MD
µA

APPLIED PART

PE S4

Figure 12. Earth leakage current test configuration.

Switch Earth electrical leakage current

Diagram Reference ESA601 Name Action Measure the earth leakage current by switch-
S1 Neutral Variable ing the function switch to the Earth Leakage
S2 Polarity Variable setting and following the ESA procedure. Make
S3 Earth Open measurement without the red lead attached to
Applied parts the device. The measurement should be made
S4 Variable
selection knob under Normal and Reverse Polarity. Ensure the
S5 — — ESA is not quickly switched between Normal
and Reverse Polarity. Record the reading or
document by exception.

©University of Vermont, Rev. 2 – Confidential 33

 DEVICE UNDER TEST
S5 DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
S1 S2

EARTH
OPEN
DUT_PE
FE

S3

CONDUCTIVE PART

MD TEST LEAD
µA
APPLIED PART

PE S4

Figure 13. Enclosure leakage current test configuration.

Chassis electrical leakage current Switch

Measure the chassis leakage current following Diagram Reference ESA601 Name Action
the ESA procedure. Make measurement with S3 Earth Open
the red lead attached to the device. The
measurement should be made under Normal
and Reverse polarity. Ensure the ESA is not
quickly switched between Normal and Reverse
polarity. Record the reading or document by
exception only.

Chassis/enclosure leakage current test.

34 ©University of Vermont, Rev. 2 – Confidential

 DEVICE UNDER TEST
S5 DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
S1 S2

EARTH
OPEN
DUT_PE
FE

S3

CONDUCTIVE PART

LEAD SELECT

MD
µA
PE S4

Figure 14. Patient leakage current test configuration.

Switch Patient applied part leakage current

Diagram Reference ESA601 Name Action Ensure the patient applied leads are attached to
S1 Neutral Variable the appropriate connectors on the ESA (e.g. see
S2 Polarity Variable Figure 8) per the ESA manual. Switch the func-
S3 Earth Variable tion switch to Patient Lead Leakage or Applied
Applied parts Parts Leakage per the ESA instructions. Make
S4 Variable
selection knob measurements with the red lead attached to
S5 — — the device. The measurement should be made
under Normal and Reverse polarity. Ensure
the ESA is not quickly switched between
Normal and Reverse polarity. The test should
be performed by selecting all leads connected
together and individual leads measured in
respect to ground. Record the reading or docu-
ment by exception only.

Chassis/enclosure leakage current test.

©University of Vermont, Rev. 2 – Confidential 35

 DEVICE UNDER TEST
S5 DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
S1 S2

EARTH OPEN
DUT_PE
FE

S3

CONDUCTIVE PART

TEST LEAD
RED TERMINAL

PE S6

1:1.1
MD LEAD SELECT
L1 µA

L2
ISOLATION S4
TRANSFORMER

Figure 15. Mains on applied parts leakage current test configuration.

Lead isolation test/mains on applied Switch

parts leakage Diagram Reference ESA601 Name Action
This test applies the power line or mains S1 Neutral Closed
voltage to the patient applied parts so cau- S2 Polarity Variable
tion should be taken in not to come in contact S3 Earth Closed
with the patient applied parts during this test. S4 M.A.P./500 V Variable
Ensure the Patient Applied Leads are attached S5 — —
to the appropriate connectors on the ESA (e.g. Applied parts
S6 Variable
see Figure 8) per the ESA manual. Switch the selection knob
function switch to Patient Lead Leakage or
Applied Parts Leakage per the ESA instruc-
tions. Make measurements with the RED lead
attached to the device. The measurement
should be made under Normal and Reverse
polarity. Ensure the ESA is not quickly switched
between Normal and Reverse polarity. The test Return to service
should be performed by selecting ALL leads Before returning to use, return any controls that
connected together and individual leads mea- were adjusted to their original settings. Plug in
sured in respect to ground. Record the reading the power cord to ensure the battery remains
or document by exception only. charged.

36 ©University of Vermont, Rev. 2 – Confidential

 CHAPTER 6: Equipment
inspection procedures

This section contains preventive maintenance

and inspection procedures for common medi-
cal equipment. Each procedure will list the
necessary test equipment, estimated time for
inspection, and an inspection check list that
can be used for documentation. The checklist is
broken up into four categories, physical condi-
tion, electrical safety, preventive maintenance,
and performance inspection. A test form for
general equipment is given for reference.

©University of Vermont, Rev. 2 – Confidential 37

 General equipment procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
Other equipment as necessary

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Calibrate to manufacturer’s specifications
Check all fluid levels
Replace battery every 24 months
Clean exterior
Lubricate as required
Complete model-specific preventive maintenance
Performance testing
Verify unit operates within manufacturer’s specifications
Operates on battery power
Audible alarms
Visual alarms
Remote alarms
Complete model-specific performance testing

38 ©University of Vermont, Rev. 2 – Confidential

Physical condition and electrical safety are • Display intensity adequate for daytime
general maintenance requirements that apply use: Verify all lights, LEDs, and displays
to all medical equipment. This information will can be easily seen in ambient light. Displays
appear on all checklists and should be per- should be able to be read easily under
formed during all inspections. These general normal operating conditions.
maintenance tasks will not be discussed in the • Control numbers, labeling, and warn-
specific device procedures. ings present and legible: Ensure all control
numbers, device labels, warning labels, or
Physical condition other labels can be easily read. Verify control
These tasks check the physical condition of the numbers and inspection stickers do not cover
equipment. These tasks should be performed for up any cautions, warning labels, or other
all medical equipment. device information.
• Device is clean and decontaminated: • Inlets and hoses: Check the condition of all
Ensure the equipment has been cleaned external tubing and hoses. Ensure they are
following patient use. Examine the exte- not cracked or kinked. Check the general
rior of the unit for cleanliness. If there are condition of the connectors. Look for damage
signs of blood or other spilled liquids, the such as stripping or cross threading. Verify
device should be cleaned per the hospital’s that connectors are tight.
equipment disinfection policy and the manu- • Power cord, patient and accessory cables,
facturer’s approved cleaning instructions. charger: Check the physical condition of the
• No physical damage to case, display,
power cord. Look for cuts, frayed wires, and
mounts, cart, or components: Examine missing insulation. Check the physical condi-
the device for general physical condition. tion of the plug, looking for bent or loose
Ensure plastic housings are intact and that prongs. Ensure strain reliefs are intact. Check
all assembly hardware is present and tight. the physical condition of cables, looking for
Examine the exterior for cracks and chips. frayed wires and loose or bent connections.
Check that shelves and brackets are secure. Ensure connections are clean and free of cor-
Check the condition of castors and ensure rosion and build up such as gel or hair. Verify
they turn and swivel as appropriate. Check that disposable accessories are within their
the operation of the brakes. expiration dates.
• Switches and controls operable and cor- • Filters and vents clean: Ensure filters and
rectly aligned: Ensure all switches, buttons, vents are free of dust and other build up. Pay
knobs, and other controls are operable. Verify special attention to cooling fans. Clean or
knobs are properly aligned with markings on replace filters as necessary.
the control panel.

©University of Vermont, Rev. 2 – Confidential 39

Electrical safety Preventive maintenance
These tasks check the electrical safety of the Complete model-specific preventive mainte-
equipment and are important to prevent a shock nance: Refer to the monitor’s service manual
to the patient. Follow the procedures given in for preventive maintenance tasks specific to the
Chapter 5, Electrical Safety. Measure ground device. Complete the preventive maintenance
wire resistance, chassis leakage. Measure per manufacturer’s procedure.
current leakage to patient leads if applicable.
Electrical safety should be checked for all Performance inspection
medical equipment. Complete model-specific performance
• Device specific tasks testing: Refer to the service manual for perfor-
Preventive maintenance and performance mance inspection tasks specific to the device.
inspection include maintenance tasks and Complete the performance inspection per
testing criteria that are specific for each manufacturer’s procedure.
device type. These tasks should be per- Returning the device to service: Upon
formed in addition to the general physical completion of maintenance, all controls should
and electrical safety tests. be returned to their previous clinical set-
As a general guideline, rechargeable bat- tings. Return all alarm limits adjusted during
teries should be replaced every 24 months. the functional test to their original locations.
Certain batteries in low-use situations such Adjust the alarm volume to an audible level.
as automatic external defibrillators may last The alarms should be able to be heard easily in
longer. The manufacturer battery replace- the normal operating environment. If the device
ment schedule should be followed if provided will not immediately be returned to use, make
in the documentation. Electrical safety sure the power cord is plugged in to ensure the
checks should be performed following a bat- battery remains charged and the equipment is
tery replacement. Always verify the operation ready for use.
of the device before replacing the battery. A
functional test should be performed following
battery replacement.
These procedures are written for general device
types. Check the equipment’s service manual
for any additional model-specific tests and
maintenance.

40 ©University of Vermont, Rev. 2 – Confidential

 Apnea monitor respiration rate, with the limits of these param-
Apnea is defined as the absence of breathing. eters adjustable by the user. An audible alarm
An apnea monitor is designed to detect this will sound when the alarm limits are exceeded
condition. The apnea monitor senses by mea- or if the monitor or when an apnea condition is
suring changes in the electrical impedance of detected. These types of monitors are typically
the thoracic cavity during respiration. Typically, used to monitor high-risk infants.
electrodes are attached to the patient with lead Recommended functional test frequency:
wires connected to the monitor. The monitor semiannual.
will usually display the patient’s heart rate and

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant History 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 13
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 41

 Apnea monitor procedure
Estimated time: 25 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
Stopwatch or watch with a second hand

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Heart rate accuracy ±5%
Respiratory rate accuracy ±5%
Apnea alarm function
Apnea alarm delay time ± 20 %
60 BPM rejection of ECG artifact
Alarm function
Complete model-specific performance testing

42 ©University of Vermont, Rev. 2 – Confidential

Physical condition Set the heart rate on the MPS450 to 120 bpm.
Check the physical condition of the device, as Press ‘1’ (NSR), and then use the soft keys
described in the General Equipment Procedure. marked ‘UP’ and ‘DOWN’ to change the heart
rate to 120 bpm.
Electrical safety Set the respiration rate to 60 breaths/min.
Press ‘2’ (RESP) and then use the soft keys to
Perform electrical safety checks as described in change the respiration rate.
Chapter 5, Electrical Safety. Check ground wire The heart rate and respiration rate should
resistance, chassis leakage, and lead leakage. be within 5 % of the set rates. For a simulated
heart rate of 120 bpm, the displayed rate should
Preventive maintenance be between 114 bpm and 126 bpm. For a res-
Replace battery: The battery should be piration rate of 60 breaths/min, the displayed
replaced every 24 months. Replace if necessary. respiration rate should be between 57 breaths/
Complete model-specific preventive main- min and 63 breaths/min.
tenance: Refer to the monitor’s service manual Apnea alarm function: On the MPS450,
for preventive maintenance tasks specific to the press the button marked ‘2’ (RESP). To simulate
device. Complete the preventive maintenance an apnea condition, press the rightmost soft
per manufacturer’s procedure. key button ‘APNE’. Use the soft keys marked
‘PREV’ and ‘NEXT’ to cycle through the apnea
Performance inspection durations and select ‘CONTINUOUS’. Press the
Verify unit operates on battery: Check that soft key labeled ‘RUN’ to start the apnea condi-
the ac power indicator is lit up when the power tion. To stop the apnea condition and return to
cord is plugged into an outlet. Unplug the ac normal respiration, press the soft key labeled
power cord and perform the remainder of the ‘STOP’. The alarm should sound for an apnea
functional test on battery power. The ac power condition. Most monitors will alarm within
indicator should go out when the power cord 30 seconds.
is unplugged and the battery indicator should Apnea alarm delay time: Simulate an apnea
light up. Be sure to plug the power cord back in condition as described in the step above. Set
at the conclusion of the test. the apnea duration to continuous. Start the
Heart rate accuracy, respiratory rate apnea simulation by pressing the soft key
accuracy: Connect the patient leads to the lead labeled ‘RUN’ and begin timing on the stop-
connectors on the MPS450. The respiratory watch. Stop timing when the apnea alarm
signal from the MPS450 is sent to the left sounds. Press the soft key labeled ‘END’ to
arm (LA) lead on the default setting. Change return to normal respiration and silence the
the respiratory signal to the left leg (LL) if alarm. Compare the actual time for the alarm to
necessary. From the main menu, press ‘0’ sound with the monitor’s alarm delay. The time
(SETUP), press the leftmost blue arrow key for should be with 20 % of the delay setting. For
‘RESP’, and then again for ‘LEAD’. This will an apnea delay of 30 seconds, the alarm should
toggle the respiratory lead from LA to LL. For sound within 36 seconds.
most purposes, the respiratory lead can be left
on left arm.

©University of Vermont, Rev. 2 – Confidential 43

 60 bpm rejection of ECG artifact: This test the monitor alarms when the respiration rate
checks the coincidence circuit designed to falls below the set low respiration limit and
reject detected breaths that may be erroneously above the high respiration limit. Set the res-
detected QRS complexes from the ECG signal. piration rate to 60 breaths/min and clear any
Press ‘2’ (RESP) to enter the Respiration alarms.
menu on the MPS450. Set the respiration rate Check the function of the accidental power off
to 60 breaths/min. Press ‘1’ (NSR) to enter the alarm. Apnea monitors used on infants are often
Normal Sinus Rhythm menu. Set the heart equipped with a ‘sibling alarm’ that sounds
rate to 60 bpm. The monitor should alarm. Set when the monitor is turned off accidentally.
the heart rate back to 120 bpm. These monitors will require a key sequence
Alarm function: Check that all alarms are to power off without sounding an alarm, such
functional and that the volume is adequately as holding the reset button while turning the
loud. Ensure appropriate visual indicators are power off. Check the operator’s manual for the
functioning. device’s specific operation. To check the alarm,
Check heart rate and respiration rate alarms press the power button without performing the
separately. Note the alarm settings on the moni- power-off button sequence. The monitor should
tor. Press ‘1’ (NSR) on the MPS450 to enter the shut down, but an alarm will sound. Follow the
Normal Sinus Rhythm menu on the MPS450. instructions in the operator’s manual to clear
Bring the heart rate down to just below the this alarm.
monitor’s low heart rate limit. The alarm should Complete model-specific performance
sound. Increase the heart rate above the low testing: Refer to the service manual for perfor-
alarm point. Clear the alarm if necessary. mance inspection tasks specific to the device.
Increase the heart rate to just above the high Complete the performance inspection per
heart rate limit. Note that the alarm sounds manufacturer’s procedure.
when the heart rate increases beyond the high Return to service: Before returning to use,
alarm limit. Set the heart rate back to 120 bpm return any alarms that were adjusted to their
and clear any alarms. original settings. Ensure the volume of the
Press ‘2’ (RESP) to enter the Respiration audible alarms is loud enough to be heard in
menu. Repeat the process for the respiration normal operating conditions. Plug in the power
rate as done for the heart rate above. Ensure cord to ensure the battery remains charged.

44 ©University of Vermont, Rev. 2 – Confidential

 Aspirator vacuum pressure. The motorized suction pump
An aspirator is sometimes known as a suction creates a vacuum in the suction tubing. When
pump or a vacuum. It uses suction to remove the tubing is inserted into a body cavity, mate-
gas, fluid, tissue, or other materials from a rial is sucked through the tubing and deposited
body cavity. An aspirator typically consists of a into the collection container.
suction pump, a collection container, tubing, a Recommended functional test frequency:
pressure gauge, and a means for adjusting the annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 45

 Aspirator procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)  DPM 4 Pressure Meter (or equivalent)
  Stopwatch or watch with a second hand   Tubing and connectors to connect to DPM 4

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Replace filters
Lubricate motor
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Vacuum gauge accuracy ± 10 %
Maximum vacuum Thoracic, low volume: > 40 mmHg
Emergency, surgical, tracheal, uterine: > 400 mmHg
Breast pump: > 200 mmHg
Vacuum rise time Thoracic: < 4 sec/30 mmHg
Emergency, Surgical, Tracheal: < 4 sec/300 mmHg
Uterine: < 3 sec/30 mmHg
Breast pump: < 2 sec/150 mmHg
Complete model-specific performance testing

46 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Performance inspection
Check the physical condition of the device, as Verify unit operates on battery: Check that
described in the General Equipment Procedure. the ac power indicator is lit when the power
cord is plugged into an outlet. Unplug the ac
Electrical safety power cord and perform the remainder of the
Perform electrical safety checks as described in functional test on battery power. The ac power
Chapter 5, Electrical Safety. Check ground wire indicator should go out when the power cord
resistance and chassis leakage. is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
Preventive maintenance conclusion of the test.
Vacuum gauge accuracy: Turn on the DPM 4.
Replace battery: The battery should be
The DPM 4 defaults to pressure units in mmHg.
replaced every 24 months. Replace if necessary.
If the pressure gauge is in another unit, press
Replace filters: Inspect filters and replace as
the soft key labeled ‘UNIT’ and then select the
necessary. Refer to the device service manual
desired units. Most aspirators measure vacuum
for filter replacement.
in mmHg. The DPM 4 should read ‘0.0’ mmHg
Lubricate motor: Follow the manufacturer’s
when the pressure port is open to atmosphere.
instructions in the service manual for lubricat-
Connect the aspirator to the pressure port on
ing the pump motor. Not all motors will need to
the front of the DPM 4. This connector is a male
be lubricated.
leur lock connector. The connection from the
Complete model-specific preventive main-
aspirator should come from the port intended for
tenance: Refer to the monitor’s service manual
the patient tubing.
for preventive maintenance tasks specific to the
Turn on the aspirator and adjust the vacuum
device. Complete the preventive maintenance
to a low setting. Slowly increase the vacuum
per manufacturer’s procedure.
across its range up to the maximum setting.
Compare the vacuum gauge reading with the
measured vacuum from the DPM 4. The gauge
reading should be within 10 % of the mea-
sured vacuum. For a vacuum gauge reading of
300 mmHg, the measured vacuum should be
between 270 mmHg and 330 mmHg.
Maximum vacuum: Disconnect the suction
tubing from the DPM 4 and occlude the suction
tubing. The tubing can be occluded with a stop-
cock in the off position or by simply covering the
tubing with your thumb. Adjust the suction to its
maximum setting. The accuracy of the vacuum
gauge must be verified prior to this test. The
values on the test form are guidelines based on
common practice. Refer to the aspirator’s opera-
tor manual for its actual performance capability.
If the measured vacuum is low, look for air leaks,
particularly in collection bottle caps and hoses.
Release the occlusion on the tubing.

Verifying aspirator vacuum accuracy with the DPM 4.

©University of Vermont, Rev. 2 – Confidential 47

 Vacuum rise time: With the aspirator set to common practice. Refer to the aspirator’s opera-
its maximum setting, occlude the suction tubing. tor manual for its actual performance capability.
Use a stopwatch or a watch with a second Complete model-specific performance
hand to measure the time it takes to reach the testing: Refer to the service manual for perfor-
vacuum level indicated on the test form. Tho- mance inspection tasks specific to the device.
racic aspirators should reach 30 mmHg in less Complete the performance inspection per
than 4 seconds. Emergency, surgical, or tracheal manufacturer’s procedure.
aspirators should reach 300 mmHg in less than Return to service: Before returning to use,
4 seconds. Uterine aspirators should reach return the suction setting to its original setting.
300 mmHg in less than 3 seconds. Breast pumps Plug in the power cord to ensure the battery
should reach 150 mmHg in less than 2 seconds. remains charged.
Again, these are general guidelines based on

48 ©University of Vermont, Rev. 2 – Confidential

 Cardiac output unit temperature of the surrounding blood is
A cardiac output unit measures the volume of measured through a thermistor located near
blood pumped by the heart during a period of the tip of the catheter. Once the catheter is
time, typically measured in liters per minute inserted, ice water is injected through the
(L/min). Cardiac output represents the volume catheter and emerges from a small hole approx-
of blood that is delivered to the body is an imately 12 inches before the end of the catheter.
indicator of overall cardiac status and tissue The cardiac output unit processes the signal
perfusion. Blood flow from the heart is mea- from the thermistor and displays a thermal
sured using the thermal dilution technique in dilution curve from which cardiac output and
which a cold solution is injected upstream of other hemodynamic parameters such as stroke
the heart and the temperature differential is volume can be derived.
monitored on the downstream side. A balloon Recommended functional test frequency:
catheter is inserted through the heart. The annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 49

 Cardiac output monitor procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
Cardiac output adapter box 
Cables to connect to cardiac output monitor

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Performance testing
Verify accuracy of blood temperature 37 °C ± 0.2 °C
Verify cardiac output accuracy
Complete model-specific performance testing

50 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Turn on the MPS450. Press the button labeled
Check the physical condition of the device, as ‘8’ (‘CO’) to enter the cardiac output menu.
described in the General Equipment Procedure. The blood temperature displayed on the car-
diac output monitor should read 37 °C ± 0.2 °C.
Electrical safety Verify cardiac output accuracy: With the
cardiac output monitor and MPS450 set up as
Perform electrical safety checks as described in above, enter the cardiac output menu on the
Chapter 5, Electrical Safety. Check ground wire MPS450 by pressing ‘8’ (CO). Press the soft key
resistance and chassis leakage. labeled ‘INJ’ to toggle the injectate temperature
between 0 °C and 24 °C. Set the injectate tem-
Performance inspection perature to 24 °C.
Verify accuracy of blood temperature: Adjust Turn the trimpot on the cardiac output box
the settings on the cardiac output monitor as until the injectate temperature on the cardiac
follows. Set the catheter type/size to Baxter monitor reads 24 °C.
Edwards, 93a-131-7f. Set the calibration coef- The simulated flow rate on the MPS450 can
ficient to 0.595. Set the injectate volume to be set to 2.5 L/min, 5.0 L/min and 10.0 L/min
10 cc. Set the injectate temperature to 24 °C. by pressing the soft keys labels ‘PREV’ and
Connect the cardiac output box to the ‘NEXT’ to scroll through the values. The car-
‘CO/TEMP’ port on the right hand side of the diac output should be checked at each of these
MPS450. Connect the blood temperature therm- settings.
istor cable from the cardiac output monitor to Set the volume on the MPS450 to 2.5 L/min.
the small 4 pin connector on the cardiac output Initiate a cardiac output measurement on the
adapter. Connect the injectate temperature from monitor. Press the soft key labeled ‘RUN’ on the
the cardiac output monitor to the large 4-pin MPS450 to start the simulation. If you need to
connector on the cardiac output box located just end the simulation before the cardiac output
above the resistance trimpot. calculation is complete, press the soft key
labeled ‘STOP’. Repeat this measurement for the
5.0 L/min and 10.0 L/min rates.
Complete model-specific performance
testing: Refer to the service manual for perfor-
mance inspection tasks specific to the device.
Complete the performance inspection per
manufacturer’s procedure.
Return to service: Before returning to use,
return the cardiac output monitor to its original
settings.

Connecting the cardiac output monitor to the MPS450.

©University of Vermont, Rev. 2 – Confidential 51

Central station ECG strips. Bedside monitors will be connected
Central stations are monitors that are designed to the central station computer through the
to be positioned in a central location, usually hospital’s network. If telemetry transmitters are
at a nurse’s station and consolidate information used for remote monitoring, an antenna system
from individual bedside and telemetry moni- and receivers will be necessary for receiving
tors. The central station usually displays an ECG the radio signal. Central stations are used for
waveform for each patient being monitored, and remote monitoring of patients in one or more
also any alarms that are triggered. Central sta- areas of a hospital. They do not replace bedside
tions typically consist of one or more displays, a monitors.
computer that runs the central station, speakers Recommended functional test frequency:
for audible alarms, and a recorder for printing annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

52 ©University of Vermont, Rev. 2 – Confidential

 Central station monitoring
system procedure
Estimated time: 35 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
Index 2 SpO2 Simulator (or equivalent)
Vacuum or canned air for clearing dust from cooling fans

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean dust from cooling fans
Complete model-specific preventive maintenance
Performance testing
Verify display is clear and legible
Verify monitoring capabilities of hard wired monitors
Verify monitoring capabilities of telemetry transmitters
Verify recorder accuracy ±4%
Verify operation of alarms
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 53

Physical condition the left side MPS450. Press ‘1’ (NSR) to enter the
Check the physical condition of the device, as normal sinus rhythm menu. Set the heart rate to
described in the General Equipment Procedure. 80 bpm. If the telemetry has SpO2 capabilities,
connect the finger probe to the Index 2 Pulse
Electrical safety Oximeter Simulator as described in the Pulse
Oximeter Procedure.
Perform electrical safety checks as described in Ensure that a battery is installed in the
Chapter 5, Electrical Safety. The central station telemetry transmitter. Admit a test patient on
will not be able to be removed from power for this telemetry channel. Verify that the central
testing and will need to be tested as perma- station displays the ECG rhythm and heart rate.
nently installed medical equipment. Discharge the test patient when finished. The
process will need to be repeated for each telem-
Preventive maintenance etry transmitter.
Clean dust from cooling fans: The comput- Verify recorder accuracy: With a test patient
ers that run central station monitoring systems admitted to the central station and the ECG
are often situated under desks. As the cooling leads connected to the MPS450 as above, press
fans accumulate a lot of dust and debris, they ‘1’ (NSR) on the MPS450. Set the heart rate
can become clogged and lead to overheating to 60 bpm. Initiate strip record on the central
of the computer system. Use a small vacuum or station.
a canned air to remove dust from the fans and Measure the distance between the peaks
vents. A vacuum is preferred over compressed of the QRS complex. With a recorder speed of
air, as it will not blow dust around the patient 25 mm/sec, the QRS peaks should be between
care area. 24 mm and 26 mm apart.
Complete model-specific preventive main- Verify operation of alarms: Check that all
tenance: Refer to the monitor’s service manual alarms are functional and that the volume is
for preventive maintenance tasks specific to the adequately loud. Ensure that appropriate visual
device. Complete the preventive maintenance indicators are functioning.
per manufacturer’s procedure. Note the alarm settings on the central sta-
tion. Press ‘1’ (NSR) to enter the Normal Sinus
Performance inspection Rhythm menu. Bring the heart rate down to just
Verify display is clear and legible: The monitor below the monitor’s low heart rate limit. The
should be clear and bright enough to read. Look alarm should sound. Increase the heart rate
for distortion around the edges of the screen. above the low alarm point. Clear the alarm if
Verify monitoring capabilities of hard- necessary. Increase the heart rate to just above
wired monitors: Connect the MPS450 to a the high heart rate limit. Verify that the alarm
monitor following the instructions given in the sounds when the heart rate increases beyond
Patient Monitor procedure. At a minimum simu- the high alarm limit. Set the heart rate back to
late a heart rate and respiration. Attach the ECG 80 bpm and clear any alarms.
lead wires to the lead connectors on the left Complete model-specific performance
side of the MPS450. The MPS450 will default to testing: Refer to the service manual for perfor-
a normal sinus rhythm of 80 bpm. mance inspection tasks specific to the device.
Admit a test patient in this bed on the central Complete the performance inspection per
station. Verify that the central station displays manufacturer’s procedure.
the ECG wave, heart rate, and other monitored Return to service: Discharge any test
parameters. Discharge the test patient. patients. Return any alarms that were adjusted
Verify monitoring capabilities of telemetry to their original settings. Ensure the volume of
transmitters: Connect the ECG leads of the the audible alarms is loud enough to be heard
telemetry transmitter to the lead connections on in normal operating conditions.

54 ©University of Vermont, Rev. 2 – Confidential

 Compression unit tubing, and cuffs that wrap around the patient’s
Compression units are designed to apply and limbs. Air is pumped through the tubing into
release pressure on a patient’s limbs in order to the cuffs until the pressure inside the cuff
facilitate the return of blood through the veins. reaches a set pressure. The cuff remains
They are used to reduce the risk of deep vein inflated at the set pressure for a set period of
thrombosis during long periods of immobiliza- time. Pressure is then relieved from the cuff and
tion, which can lead to pulmonary embolism. the cuff remains deflated for another set period
Compression units are also used during and of time. The compression unit will continuously
immediately following surgery to minimize repeat this cycle of inflation and deflation.
venous stasis. A compression unit typically Recommended functional test frequency:
consists of an air compression pump, a pres- annual.
sure control mechanism, a timing mechanism,

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 55

 Compression unit procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
DPM 4 Pressure Meter (or equivalent)
Stopwatch or watch with a second hand
Tubing and connectors to connect to DPM 4
Compression set
PVC pipe to attach compression set to

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Pressure accuracy ±2%
Timing cycle accuracy ±2%
Alarm function
Complete model-specific performance testing

56 ©University of Vermont, Rev. 2 – Confidential

 Physical condition functional test on battery power. The ac power
Check the physical condition of the device, as indicator should go out when the power cord
described in the General Equipment Procedure. is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
Electrical safety conclusion of the test.
Pressure accuracy: A tubing set that can
Perform electrical safety checks as described in connect to the compression unit and to the DPM
Chapter 5, Electrical Safety. Check ground wire 4 will be needed for this test. A simple test set
resistance and chassis leakage can be constructed from a disposable compres-
sion set. Cut the tubing a short distance from
Preventive maintenance the connector for the compression unit. Insert a
Replace battery: The battery should be luer connector into the tubing to connect to the
replaced every 24 months. Replace if necessary. DPM 4. If the compression set has multiple infla-
Complete model-specific preventive main- tion tubes, occlude the remaining open tubing
tenance: Refer to the monitor’s service manual using tie-wraps.
for preventive maintenance tasks specific to the Connect the test set to the compression unit.
device. Complete the preventive maintenance The DPM 4 defaults to pressure units in mmHg.
per manufacturer’s procedure. If the pressure gauge is in another unit, press
the soft key labeled ‘UNIT’ and then select the
Performance inspection desired units. Most compression units measure
Verify unit operates on battery: Check that pressure in mmHg. The DPM 4 should read
the ac power indicator is lit when the power ‘0.0’ mmHg when the pressure port is open to
cord is plugged into an outlet. Unplug the ac atmosphere. Connect the test set to the pressure
power cord and perform the remainder of the port of the DPM 4.
Start the compression cycle on the compres-
sion unit. Measure the reading using the DPM
4 and compare this value with the display on
the compression unit. If the compression unit
has multiple settings, measure the pressure
readings throughout its range. The pressure
displayed on the compression unit should be
within 2 % of the pressure measured on the
DPM 4. For a pressure reading of 45 mmHg, the
measured pressure should be between
44 mmHg and 46 mmHg.

Testing pressure accuracy of a compression unit with the DPM 4.

©University of Vermont, Rev. 2 – Confidential 57

 Timing cycle accuracy: Disconnect the Alarm function: Check that all alarms are
DPM 4 and test tubing from the compression functional and that the volume is adequately
unit and connect a complete compression set. loud. Ensure that appropriate visual indicators
For testing, attach the compression set to a are functioning.
piece of PVC pipe or other rigid pipe to simu- Complete model-specific performance
late a limb. Start the compression cycle. Use a testing: Refer to the service manual for perfor-
stopwatch or a watch with a second hand to mance inspection tasks specific to the device.
measure the length of time the pressure is held. Complete the performance inspection per
When the compression unit deflates, measure manufacturer’s procedure.
the length of time before the next inflation. Return to service: Before returning to use,
Compare the measured times to the compres- return the compression cycle setting to its origi-
sion unit’s setting. The measured time should nal setting. Plug in the power cord to ensure
be within 2 % of the set time. the battery remains charged.

58 ©University of Vermont, Rev. 2 – Confidential

 Defibrillator selectable from 0 J to 360 J. Most defibrillators
Defibrillators deliver electric impulse to the also include an electrocardiograph to moni-
heart through the chest wall in order to restore tor the patient’s rhythm. Some defibrillators
a normal rhythm in patients experiencing ven- include a pacer function. Electrical impulses
tricular fibrillation or ventricular tachycardia. are delivered to the heart, causing the heart to
The high electrical energy stops the indepen- contract. This is used for emergency treatment
dent action of the individual muscle fibers, so of asystole, severe bradycardia, implantable
that the natural pacemaker of the heart can pacemaker failure, or other conditions requiring
take over. A set charge is generated and is emergency cardiac pacing.
delivered through a set of paddles or disposable Recommended functional test frequency:
defibrillation electrodes through the chest wall. semiannual.
The defibrillator’s output energy is typically

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 13
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 59

 Defibrillator procedure
Estimated time: 30 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
Impulse 4000 Defibrillator and Pacer Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
Ohmmeter (Can be part of a multimeter, such as the Fluke 73 series digital multimeter)
Cables and connectors to connect defibrillator to analyzer

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC, < 500 µA SFC
Patient leakage current < 100 µA B and BF, < 10 µA CF
Patient lead leakage current – isolation test (mains on patient applied part) < 100 µA BF, < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Verify electrodes, gel and paddles are stored with the defibrillator and are within expiration dates
Verify proper time and date, correct if necessary
Complete model-specific preventive maintenance

continued on page 61

60 ©University of Vermont, Rev. 2 – Confidential

continued from page 60

Test Result
Pass Fail N/A
Performance testing
Verify unit operates on battery
Paddle continuity ≤ 0.15 W
Heart rate accuracy ±5%
Recorder speed ±4%
Verify operation of alarms
Output accuracy ± 15 %
Output energy at maximum setting for 10 charge cycles ± 15 %
Charge time after 10 discharge cycles ≤ 15 sec
Energy after 60 sec of full charge ≥ 85 %
Internal discharge function
Synchronizer operation ≤ 60 msec
Pacer output accuracy ± 10 %
Pacer rate accuracy ±5%
Demand-mode sensitivity
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 61

Physical condition Paddle continuity: Connect the ohmmeter
Check the physical condition of the device, as between a paddle and the appropriate pin on
described in the General Equipment Procedure. the paddle connector. The resistance should
not be higher than 0.15 W. Repeat for the other
Electrical safety paddle. This step can be skipped if only dispos-
able paddles are used.
Perform electrical safety checks as described in Heart rate accuracy: Connect the ECG leads
Chapter 5, Electrical Safety. Check ground wire to the lead connectors on the Impulse 4000. On
resistance, chassis leakage, and lead leakage. the Impulse 4000, press F3 ‘ECG’ to enter the
ECG menu. Press F1 ‘NORM’ to select a normal
Preventive maintenance sinus rhythm. Press F2 ‘60’ to set the heart
Replace battery: The battery should be rate to 60 bpm. On the defibrillator, set the ECG
replaced every 24 months. Replace if necessary. source to Lead II.
Verify electrodes and defibrillator gel or dispos- The heart rate should be within 5 % of the
able paddles are stored with the defibrillator set rate. For a simulated heart rate of 60 bpm,
and are within expiration dates: Verify that the displayed rate should be between 57 bpm
ECG electrodes are stored with the unit. If hard and 63 bpm. Set the heart rate on the Impulse
paddles are used, verify that defibrillator gel is 4000 bpm to 120 bpm. The displayed heart rate
stored with the unit. The conductive gel should should be between 114 bpm and 126 bpm.
be for use with defibrillators and lotion, skin Recorder speed: Set the heart rate on the
lubricant, or ultrasound gel should not be used. Impulse 4000 bpm to 60 bpm. Record a strip on
If hard paddles are not used, verify that dis- the defibrillator. Measure the distance between
posable pads are stored with the unit. Check the peaks of the QRS complex. With a recorder
the expiration date on the electrodes, gel, and speed of 25 mm/sec, the QRS peaks should be
disposable paddles. between 24 mm and 26 mm apart.
Verify proper time and date. Correct if Verify operation of alarms: Check that all
necessary: Verify the time and date displayed alarms are functional and that the volume is
on the defibrillator is correct. If the time and adequately loud. Ensure appropriate visual indi-
date is not displayed on the defibrillator moni- cators are functioning.
tor, print a strip from the recorder. The time and Note the alarm settings on the defibrillator.
date should appear on the printed strip. Correct Set the low limit to 35 bpm and the high limit
the time and date as necessary. 155 bpm. The alarm limits may not be able to
Complete model-specific preventive main- be set to these exact values, depending on the
tenance: Refer to the monitor’s service manual defibrillator. If that is the case, set the alarm
for preventive maintenance tasks specific to the limits to the next closest value, keeping the low
device. Complete the preventive maintenance limit above 30 bpm and the high limit below
per manufacturer’s procedure. 160 bpm.
Press F3 ‘ECG’ on the Impulse 4000 to enter
Performance inspection the ECG menu. Press F1 ‘NORM’ to select a
Verify unit operates on battery: Check that normal sinus rhythm. Set the heart rate to
the ac power indicator is lit when the power 30 bpm. The alarm should sound. Increase
cord is plugged into an outlet. Unplug the ac the heart rate to 80 bpm and clear the alarm
power cord and perform the remainder of the if necessary. Set the heart rate to 160 bpm.
functional test on battery power. The ac power Verify that the alarm sounds when the heart
indicator should go out when the power cord rate increases beyond the high alarm limit. Set
is unplugged and the battery indicator should the heart rate back to 80 bps and clear any
light. Be sure to plug the power cord in at the alarms. Return the alarm limits to their previous
conclusion of the test. settings.

62 ©University of Vermont, Rev. 2 – Confidential

 Output accuracy: Connect the defibrillator Output energy at maximum setting for
paddles to the paddle contacts on the Impulse 10 charge cycles: Set the energy on the
4000. The Apex contact is on the right and the defibrillator to the maximum setting. Charge
Sternum contact is on the left. the defibrillator and then discharge into the
If disposable paddles are being used, you will Impulse 4000. Repeat this charge and dis-
need a test set to connect from the defibrilla- charge cycle 10 times. On the tenth shock, the
tor cable to the Impulse 4000. A simple test set energy output should still be within 15 % of the
can be made from a set of disposable paddles. setting.
Cut the pads off of the set leaving the connec- Charge time after 10 charge cycles: Mea-
tor and two lengths of wire. Strip the ends of sure the charge time on the maximum energy
the wires and install banana plugs. Insert the setting after 10 discharge cycles. From the
banana plugs into the paddle contacts of the ‘DEFIB’ menu on the Impulse 4000, select F3
Impulse 4000. Connect the test set to the defi- ‘MEXE’. Press F2 ‘HIGH’ for the high energy
brillator cable. range. Connect the defibrillator paddles to the
With the Impulse 4000 set to a heart rate of paddle contacts on the Impulse 4000. Press
80 bpm, set the ECG source on the defibrillator F3 ‘START’ and immediately start charg-
to paddles. View the ECG trace on the defibril- ing the defibrillator. When the defibrillator
lator. If the trace appears upside down, reverse is fully charged, immediately discharge into
the paddle connections. the Impulse 4000. The energy output and the
Return to the main menu of the Impulse charge time will be displayed. The charge time
4000. Press F1 ‘DEFIB’ to enter the defibrillator should not exceed 15 s.
menu. Press F1 ‘ENERGY’ then F2 ‘HIGH’. The Energy after 60 sec of full charge: Charge
high setting is for energy output up to 1000 J; the defibrillator at its maximum setting. Wait
the low setting is for measuring 50 J and below. 60 seconds and then discharge into the Impulse
Measure the energy output of the defibrillator 4000. The output should be at least 85 % of the
throughout its range. At a minimum, measure energy setting. At a setting of 360 J, the output
the output at the lowest setting, a mid level should be at least 306 J.
setting, and the highest setting. The output Internal discharge function: The defibrilla-
should be within 15 % of the set energy level. tor should have a method of discharging stored
At 360 J, the energy output should be between energy. Some models have a button on the
306 J and 414 J. front panel for this function. Others release the
energy after a set time or when the defibril-
lator is turned off. Check the service manual
for specific operation of the internal discharge
function. Charge the defibrillator and do not
discharge. Allow the energy to be discharged
internally. Attempt to discharge into the Impulse
4000. Verify that no energy has been delivered.
Sychronizer operation: Set the ECG source
on the defibrillator to Lead II. Put the defibrilla-
tor into synch mode. Return to the main menu
of the Impulse 4000. Press F1 ‘DEFIB’ to enter
the defibrillator menu. Press F2 ‘CARDIO’ for the
cardioversion menu and then F2 ‘HIGH’. Press
F1 ‘NSR’ for a normal sinus rhythm. Charge
the defibrillator. Press and hold the discharge
button(s) on the defibrillator. The delay time
Measuring defibrillator power output. should not be more than 60 mSec.

©University of Vermont, Rev. 2 – Confidential 63

 Pacer output accuracy: Connect the ECG Adjust the pulse rate on the pacer to just below
leads to the lead connectors on the MPS450. 60 ppm. The output should stop. No output
Set the heart rate on the MPS450 to 60 bpm. should be measured on the Impulse 4000 and
Press ‘1’ (‘NSR’), and then use the soft keys pacing spikes should not appear on the ECG
marked ‘UP’ and ‘DOWN’ to change the heart trace. Adjust the pulse rate to just above
rate to 60 bpm. On the defibrillator, set the ECG 60 ppm. Pacing should start again.
source to Lead II. Connect the ECG leads to the Impulse 4000.
Connect the pacing cable to the defibrillator From the Pacer menu, press F3 ‘DEMAND’. With
if necessary. You will need a test set to connect the pacer in demand mode, press F1 ‘START’.
the pacing cable to the Impulse 4000. A test The Impulse 4000 will display the calculated
set can be made from the disposable pads as underdrive and overdrive ECG rates.
described previously. A havertriangle waveform will be displayed
From the main menu of the Impulse 4000, on the ECG trace. Pacing spikes should appear
press F2 ‘PACER’. Press F1 ‘INT50W’ to select on the ECG trace. Press F2 ‘OVER’ to select the
the internal 50 W test load. Press F1 ‘PULSE’ overdrive ECG rate. Verify that the pacing stops
to enter the pacer measurement mode. Set the with this higher rate. Turn off the pacer and
pacing rate on the defibrillator to 120 ppm. return the output and rate to their previous
Set the defibrillator output to the minimum settings.
setting and start pacing. The ECG wave form Return to service: Before returning to use,
should display pacing spikes at approximately return any alarms that were adjusted to their
the mid point between QRS peaks and on top original settings. Ensure the volume of the
of QRS peaks. The impulse 4000 will display audible alarms is loud enough to be heard in
the pacer output amplitude in mA. Measure the normal operating conditions. Ensure the pacer
pacer output over its entire range. The mea- is turned off and that any settings that were
sured output should be within 10 % of the set adjusted are returned to their original settings.
output. For an amplitude setting of 100 mA, Plug in the power cord to ensure the battery
the measured output should be between 90 mA remains charged and ready for use.
and 110 mA. Complete model-specific performance
testing: Refer to the service manual for perfor-
***IMPORTANT*** mance inspection tasks specific to the device.
DO NOT TOUCH THE PADDLE Complete the performance inspection per
CONTACTS ON THE IMPULSE 4000 manufacturer’s procedure.
WHILE THE DEFIBRILLATOR PACER
IS ON. TURN THE PACER OFF
BEFORE ADJUSTING OR REMOVING
CONNECTIONS.

Pacer rate accuracy: While measuring pacer

output, the Impulse 4000 also displays the
pulse rate. The measured pulse rate should
be within 5 % of the set rate. For a rate of
120 ppm, the pulse rate should be between
114 ppm and 126 ppm. Set the heart rate on
the MPS450 to 30 bpm. Measure the pulse rate
throughout its range.
Demand-mode sensitivity: Set the heart rate
on the MPS450 to 60 bpm. Turn on demand
mode on the defibrillator pacer if necessary.
Measuring pacer output with the Impulse 4000.

64 ©University of Vermont, Rev. 2 – Confidential

 Electrocardiograph from 12 groups of leads. These are commonly
An electrocardiograph (ECG) records the electri- referred to as 12 lead ECGs. In addition, diag-
cal activity of the heart over time by measuring nostic ECGs typically contain an interpretation
the changes of electrical potential caused by function, where the measured signals of the
electrical activity of the heart muscle during the cardiac activity are analyzed using an internal
heartbeat. Leads affixed to the patient transmit algorithm. Diagnostic ECGs do not usually have
the electrical signal to the processor, which heart rate alarms. An ECG monitor will have 3
then produces a graph of the amplitude of the or 5 lead wires and is used for monitoring as
signal versus time as the electrocardiogram. opposed to diagnosis. ECG monitors will have
The electrocardiogram is used particularly in adjustable heart rate alarms.
diagnosing abnormalities of the heart. Diag- Recommended functional test frequency:
nostic ECGs typically have 10 physical lead annual.
wires but measures the electrical potential

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 65

 Electrocardiograph procedure
Estimated time: 25 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Clean rollers and paper guides
Lubricate motor and paper drive mechanism
Verify proper time and date. Correct if necessary
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Heart rate accuracy ±5%
Amplitude accuracy ±5%
Recorder speed ±4%
Paper cue
Alarm function
Complete model-specific performance testing

66 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Clean rollers and paper guides: Inspect the
Check the physical condition of the device, as rollers and paper guides and remove any debris.
described in the General Equipment Procedure. Check for bits of torn paper caught in the rollers.
Lubricate motor and paper drive mecha-
Electrical safety nism: Follow the manufacturer’s instructions
in the service manual for lubricating the motor
Perform electrical safety checks as described in and paper drive mechanism. Not all motors will
Chapter 5, Electrical Safety. Check ground wire need to be lubricated.
resistance, chassis leakage, and lead leakage. Complete model-specific preventive main-
tenance: Refer to the monitor’s service manual
Preventive maintenance for preventive maintenance tasks specific to the
Replace battery: The battery should be device. Complete the preventive maintenance
replaced every 24 months. Replace if necessary. per manufacturer’s procedure.
Verify proper time and date. Correct if nec-
essary: Verify that the time and date displayed Performance inspection
on the electrocardiograph is correct. If the time Verify unit operates on battery: Check that
and date is not displayed on the monitor, print the ac power indicator is lit when the power
a strip from the recorder. The time and date cord is plugged into an outlet. Unplug the ac
should appear on the printed strip. Correct the power cord and perform the remainder of the
time and date as necessary. functional test on battery power. The ac power
indicator should go out when the power cord
is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
conclusion of the test.
Heart rate accuracy: Connect the patient
leads to the lead connectors on the MPS450. Set
the heart rate on the MPS450 to 60 bpm. Press
‘1’ (NSR), and then use the soft keys marked
‘UP’ and ‘DOWN’ to change the heart rate to
60 bpm.
The heart rate should be within 5 % of the
set rate. For a simulated heart rate of 60 bpm,
the displayed rate should be between 57 bpm
and 63 bpm. Set the heart rate on the MPS450
to 120 bpm. The displayed heart rate should be
between 114 bpm and 126 bpm.

Electrocardiograph with leads connected to MPS450.

©University of Vermont, Rev. 2 – Confidential 67

 Amplitude accuracy: With the patient leads Verify operation of alarms: Check that all
connected to the MPS450, input a normal sinus alarms are functional and that the volume is
rhythm by pressing ‘1’ (NSR). Press the soft key adequately loud. Ensure that appropriate visual
marked ‘SEL’ to select AMPL. Use the soft keys indicators are functioning. Electrocardiographs
marked up and down to change the amplitude designed for diagnosis usually do not include
to 1.0 mV. Set the sensitivity on the electrocar- hear rate alarms.
diograph to 20 mm/mV. Record a strip on the Note the alarm settings on the monitor. Press
electrocardiograph. ‘1’ (NSR) to enter the Normal Sinus Rhythm
Measure the height of the QRS peak. The menu. Bring the heart rate down to just below
measured amplitude should be within 5 % of the monitor’s low heart rate limit. The alarm
the set amplitude. For an amplitude setting of should sound. Increase the heart rate above
1 mV and a sensitivity of 20 mm/mV, the peak the low alarm point. Clear the alarm if neces-
height should be between 19 mm and 21 mm. sary. Increase the heart rate to just above the
Recorder speed: Set the heart rate on the high heart rate limit. Note that the alarm sounds
MPS450 to 60 bpm. Record a strip on the elec- when the heart rate increases beyond the high
trocardiograph. Measure the distance between alarm limit. Set the heart rate back to 60 bpm
the peaks of the QRS complex. With a recorder and clear any alarms.
speed of 25 mm/sec, the QRS peaks should be Complete model-specific performance test-
between 24 mm and 26 mm apart. ing: Refer to the service manual for performance
Paper cue: Verify the operation of the paper inspection tasks specific to the device. Complete
cue, if equipped. Initiate a page advance on the performance inspection per manufacturer’s
the electrocardiograph. The paper should stop procedure.
Return to service: Before returning to use,
at the beginning of the next page. If the paper
return any alarms that were adjusted to their
does not stop or stops at an incorrect location, original settings. Ensure the volume of the audi-
ensure the correct paper is being used with the ble alarms is loud enough to be heard in normal
electrocardiograph. Clean the optical sensor if operating conditions. Plug in the power cord to
necessary. ensure the battery remains charged.

68 ©University of Vermont, Rev. 2 – Confidential

 Electrosurgical unit on the hand piece holding the electrode, or by
Electrosurgical units (ESU) use electrical a footswitch. An ESU may use a monoploar or
energy for cutting tissue and for controlling a bipolar mode. In monoplar mode, electrical
bleeding by causing coagulation using a high- current is delivered to the patient by an active
frequency electric current. Tissue resistance cable and electrode and returns to unit through
to the high-frequency, high-density current a return electrode. In bipolar mode, two elec-
results in a heating effect that causes tissue trodes, typically the tips of a pair of forceps or
destruction. Electrical current is delivered and scissors, serve as the equivalent of the active
received through cables and electrodes. The and dispersive leads in the monopolar mode.
electrodes may be activated by either a switch Recommended functional test frequency:
semiannual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers /regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 13
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 69

 Electrosurgical unit procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
QA-ES II Electrosurgery Analyzer (or equivalent)
Cables and connectors to connect ESU to QA-ES II

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace filters as necessary
Complete model-specific preventive maintenance
Performance testing
Inspect dispersive electrode
Operation of footswitch
Output power ± 15 %
Return electrode monitor
Alarms
Complete model-specific performance testing

70 ©University of Vermont, Rev. 2 – Confidential

Physical condition Performance inspection
Check the physical condition of the device, as Inspect dispersive electrode: Inspect reusable
described in the General Equipment Procedure. dispersive electrodes for cracks, bends, burn
marks, severe scratching, or a build up of gel.
Electrical safety Electrodes should be smooth and clean to allow
Perform electrical safety checks as described in the maximum contact area to the patient.
Chapter 5, Electrical Safety. Check ground wire Operation of footswitch: Check the physical
resistance and chassis leakage condition of the footswitch. Ensure the foot-
switch does not stick in the on position. Both
Preventive maintenance cut and coagulation mode should be able to be
activated from the footswitch.
Replace filters: Inspect filters and replace as
Output power: Connect the monopolar active
necessary. Refer to the device service manual
electrode of the ESU to the red ‘VAR. LOAD’
for filter replacement.
connector on the QA-ES II. Connect the dis-
Complete model-specific preventive main-
persive electrode of the ESU to the black ‘VAR.
tenance: Refer to the monitor’s service manual
LOAD’ connector on the QA-ES II.
for preventive maintenance tasks specific to the
Put the QA-ES II in continuous mode. From
device. Complete the preventive maintenance
the main menu, press F2 ‘KNOB PARAM’ until
per manufacturer’s procedure.
an asterisk (*) appears beside Mode. Turn the
encoder knob until ‘Cont. Oper’ appears on
the screen. Press F2 to adjust the test load. An
***IMPORTANT*** asterisk should appear by Load on the screen.
DO NOT TOUCH THE CABLES AND Use the encoder knob to select the load resis-
CONNECTORS FROM THE ACTIVE tance. Check the ESU’s service manual for the
OR DISPERSIVE ELECTRODES appropriate load resistance.
WHILE THE ESU IS ACITVE. DO Press F3 ‘START’ to start measuring the
NOT ALLOW CABLES OR CONNEC- energy output. Put the ESU in cut mode and set
TORS TO COME IN CONTACT WITH the energy output to minimum. Activate the ESU
CONDUCTIVE SURFACES SUCH and measure the energy output on the screen of
AS METAL TABLES. DEACTIVATE the QA-ES II.
THE ESU BEFORE ADJUSTING OR Adjust the ESU output to its maximum cut set-
REMOVING CONNECTIONS. ting. Measure the output on the QA-ES II in cut
mode according to the table below. The actual
output should be within 15 % of the set output.
For an output setting of 300 W, the measured
output should be between 225 W and 345 W.
Measure the output at 75 %, 50 %, and 25 % of
the maximum setting.
Repeat the output measurements with the
ESU in coagulation mode according to the table
below. Start with the minimum setting and
then outputs at 100 %, 75 %, and 25 % of the
maximum setting. All measurements should be
within 15 % of the set output.

ESU with handpiece connected to QA-ES II.

©University of Vermont, Rev. 2 – Confidential 71

 Power setting Output (± 15 %) Test results
Test mode % of max Setting Low High Reading Pass Fail
Cut 100 % 300 W 255 W 345 W
75 % 225 W 191.3 W 258.8 W
50 % 150 W 127.5 W 172.5 W
25 % 75 W 63.8 W 86.3 W
Coagulation 100 % 120 W 102 W 138 W
75 % 90 W 76.5 W 103.5 W
50 % 60 W 51 W 69 W
25 % 30 W 25.5 W 34.5 W

Remove the monopolar electrode from red the return electrode alarm. Be sure the disper-
‘VAR. LOAD’ connector on the QA-ES II and the sive electrode is placed on a non-conductive
dispersive electrode from the black connector. surface where the electrode will not come
Connect the ESU bipolar active electrode to the into contact with anyone. The load resistance
red ‘VAR LOAD’ connector. Connect the return may need to be adjusted for bipolar operation.
of the bipolar electrode to the black ‘VAR LOAD’ Repeat the output measurements detailed above
connector. The dispersive cable will need to for both cut and coagulation modes according
remain connected to the ESU to avoid activating to the table below.

Power setting Output (± 15 %) Test results

Test mode % of max Setting Low High Reading Pass Fail
Cut 100 % 50 W 42.5 W 57.5 W
75 % 37.5 W 31.9 W 43.1 W
50 % 25 W 21.3 W 28.8 W
25 % 12.5 W 10.6 W 14.4 W
Coagulation 100 % 50 W 42.5 W 57.5 W
75 % 37.5 W 31.9 W 43.1 W
50 % 25 W 21.3 W 28.8 W
25 % 12.5 W 10.6 W 14.4 W

Return electrode monitor: Connect the the alarm sounds. The return electrode alarm
dispersive electrode to the ESU and connect should also sound if the dispersive cable is
the two wires of the dispersive electrode to disconnected from the ESU. The ESU should not
the red and black ‘VAR.LOAD’ connectors of the activate when the return electrode monitor is
QA-ES II. To make a quick test set from a dis- alarming.
posable dispersive electrode, cut the electrode Verify operation of alarms: Simulate any
from the cable and separate the two wires in alarm conditions. Check that all alarms are
the dispersive cable. Strip the wires and attach functional and that the volume is adequately
banana plug connectors. loud. Ensure that appropriate visual indicators
Press F2 ‘KNOB PARAM.’ on the QA-ES II until are functioning.
the asterisk appears next to Mode. Use the Complete model-specific performance
encoder knob to select REM test and then press testing: Refer to the service manual for perfor-
enter to select the test. Press F2 ‘KNOB PARAM’ mance inspection tasks specific to the device.
to select Delay. Turn the encoder knob to set the Complete the performance inspection per
delay to 3000 ms. manufacturer’s procedure.
Press F3 ‘START’ on the QA-ES II. The load Return to service: Before returning to use,
resistance will start at 10 W and gradually return any settings that were adjusted to their
increase. Press F3 ‘STOP’ to stop the test when original settings.

72 ©University of Vermont, Rev. 2 – Confidential

 Enteral feeding pump digestive tract. These pumps will utilize a pump
Enteral feeding pumps are used in patients mechanism such as a rotary peristaltic pump,
without gastrointestinal complications who linear peristaltic pump, or a volumetric pump.
are unable or unwilling to consume adequate Most pumps record the dose rate, dose settings,
nutrients. Feeding solutions are delivered to and infused volume in the memory. Audible and
the patient through temporary or surgically visual alarms alert the user to flow changes or
implanted feeding tubes. The pumps accurately malfunctions.
control the flow of liquid feeding solutions Recommended functional test frequency:
that are administered enterally, through the annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2 1
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 73

 Enteral feeding pump procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent) 20 cc or larger syringe
IDA 4 Plus Infusion Device Analyzer (or equivalent) 3 way stopcock
Tubing set for feeding pump Tubing and connectors to
Reservoir to connect to tubing set (bag or bottle) connect to IDA 4 Plus

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean flow detector
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Pole clamp function
Flow rate accuracy ± 10 %
Volume accuracy ± 10 %
Occlusion detection pressure ± 1 psi
Alarm function
Complete model-specific performance testing

74 ©University of Vermont, Rev. 2 – Confidential

Physical condition Flow rate accuracy: Fill the infusion reser-
Check the physical condition of the device, as voir with a 1 % detergent solution in de-ionized
described in the General Equipment Procedure. water. Prepare a 1 % stock solution of detergent
such as Cole-Parmer Micro-90 in volume using
Electrical safety de-ionized water. The solution may be stored in
a closed vessel for up to 6 months. This solution
Perform electrical safety checks as described in should then be diluted 10:1 with de-ionized
Chapter 5, Electrical Safety. Check ground wire water for daily use. If the water used causes too
resistance and chassis leakage. much foaming, a 20:1 dilution is recommended.
Do not use tap water or solutions intended for
Preventive maintenance patient use, as these may harm the transducers
Clean flow detector: Inspect the flow detector in the IDA 4 Plus.
on the feeding pump. Clean any debris from the Connect the feeding tubing to the reservoir.
flow sensor. Prime the set so there is no air in the tubing.
Replace battery: The battery should be With the tubing draining into a container or
replaced every 24 months. Replace if necessary. sink, open the flow control mechanism on the
Complete model-specific preventive main- tubing set. Hold the reservoir high enough
tenance: Refer to the monitor’s service manual above the tubing so that fluid flows through the
for preventive maintenance tasks specific to the tubing under the force of gravity. Allow fluid to
device. Complete the preventive maintenance flow through the tubing until no air bubbles can
per manufacturer’s procedure. be seen in the tubing. Insert the set into the
feeding pump. Connect the three-way stopcock
Performance inspection to the channel 1 port on the IDA4 Plus. Con-
Verify unit operates on battery: Check that nect the patient feeding tubing to one port of
the ac power indicator is lit when the power the stopcock. Fill the syringe with the detergent
cord is plugged into an outlet. Unplug the ac solution and connect this to the other port of
power cord and perform the remainder of the the stopcock. Connect a piece of tubing to the
functional test on battery power. The ac power drain port of channel 1 and run the tubing into
indicator should go out when the power cord a container to catch the used solution.
is unplugged and the battery indicator should From the main menu of the IDA 4 Plus, use
light. Be sure to plug the power cord in at the the arrow keys to highlight ‘SETUP’ under
conclusion of the test. channel 1 and then press ‘ENT’. Use the arrow
Pole clamp function: Check the physical keys to highlight ‘FLOW’ and press ‘ENT’.
condition of the pole clamp. The pole clamp Select ‘PRIME’. Close the stopcock port con-
should be securely fastened to the feeding nected to the feeding tubing, leaving the ports
pump. The clamp mechanism should move to the syringe and the IDA 4 Plus open. Inject
freely. The pole clamp should secure the feed- the solution in the syringe into the IDA 4 Plus
ing pump to the IV pole. until ‘START’ appears on the screen. Select
‘AutoSTART’. The IDA 4 Plus will start the flow
test when it detects flow from the pump. Close
the port to the syringe, leaving the ports to the
tubing and the IDA 4 Plus open.

©University of Vermont, Rev. 2 – Confidential 75

 Set the flow rate on the feeding pump to Alarm function: Check that all alarms are
60 mL/hr and set the dose to 10 mL. Start the functional and that the volume is adequately
feeding pump. When the pump alarms com- loud. Ensure appropriate visual indicators are
plete, select ‘END’ on the IDA 4 Plus to end the functioning.
test. At this rate and volume, the dose should Set the rate on the pump to 100 mL/hr and
be complete in approximately 10 minutes. Clear set the volume to 100 mL. Start the pump.
the alarm on the pump. The measured flow Occlude the tubing between the reservoir and
rate should be within 10 % of the set rate. For the pump. The tubing can be occluded either
a flow rate of 60 mL/hr, the flow rate should be by closing a clamp attached to the tubing or
between 54 mL/hr and 66 mL/hr. Set the flow by pinching the tubing with a set of hemostats
rate on the pump to 120 mL/hr and the dose or pliers. The pump should alarm upstream
to 10 mL. Repeat the flow test at the higher occlusion.
flow rate. Clear the alarm and restart the pump. Occlude
The IDA 4 Plus is equipped with four chan- the tubing after the pump. The pump should
nels to analyze infusion devices. Four pumps alarm downstream occlusion. Clear the alarm.
can be run simultaneously. If the pump is equipped with an air detector
Volume accuracy: Set up the feeding pump introduce air into the tubing. This can be done
and the IDA 4 Plus as described previously in by turning the reservoir upside down until a
Flow Rate Accuracy. The IDA 4 Plus will mea- bubble of air is pulled through the tubing. Turn
sure flow rate and volume simultaneously. The the reservoir right side up. When the air bubble
delivered volume should be within 10 % of the gets to the pump, the pump should alarm air in
set volume. For a set volume of 10 mL, the mea- line. Clear the alarm. Remove the tubing from
sured volume should be within 9 mL and 11 mL. the pump and prime the set so that there is no
Occlusion detection pressure: From the air in the tubing. Reinsert the tubing set into
channel set up menu on the IDA 4 Plus, select the pump and restart the pump.
‘OCCLUSION’. Prime the IDA 4 Plus with the Simulate an empty container situation either
syringe if necessary. Set the flow rate on the by turning the reservoir upside down so that
feeding pump to 100 mL/hr. Set the volume to no fluid can get to the tubing, or by removing
10 mL or more so that the volume will not be the tubing from the reservoir. The pump should
delivered before the test is complete. Start the alarm when no fluid flow is detected.
pump. Select ‘START’ on the IDA 4 Plus. Select Complete model-specific performance
‘END’ on the IDA 4 Plus when the pump alarms testing: Refer to the service manual for perfor-
occlusion. Note the pressure at which the pump mance inspection tasks specific to the device.
alarms. Compare the measured pressure to the Complete the performance inspection per
occlusion pressure of the pump. The occlusion manufacturer’s procedure.
pressure will be specific to the model. Check Return to service: Before returning to use,
the service manual for the specific pressure. return any settings that were adjusted to their
The measured occlusion pressure should be original settings. Ensure the volume of the
within 1 psi of the pump’s occlusion pressure. audible alarms is loud enough to be heard in
For an occlusion pressure of 20 psi, the mea- normal operating conditions. Plug in the power
sured pressure should be between 19 psi and cord to ensure the battery remains charged.
21 psi.

76 ©University of Vermont, Rev. 2 – Confidential

 External pacemaker chambers of the heart are stimulated simul-
External pacemakers electric impulse to the taneously. External pacemakers are used to
heart through the chest wall in order to tempo- assist in resuscitation, correct arrhythmias such
rary pacing of the heart. External pacemakers as asystole or bradycardia, or to temporarily
consist of electronic circuitry that controls the pace during procedures that may induce these
pulse rate and output current and a two lead arrhythmias.
cable used to connect it to disposable adhesive Recommended functional test frequency:
electrodes. Electrical impulses are delivered semiannual.
to the heart, causing the heart to contract. All

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 14
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 77

 External non-invasive
pacemaker procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
SigmaPace 1000 External Pacemaker Analyzer (or equivalent)
Cables and connectors to connect pacemaker to analyzer

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Rate accuracy ±5%
Output accuracy ± 10 %
Pulse width ± 10 %
Alarm function
Complete model-specific performance testing

78 ©University of Vermont, Rev. 2 – Confidential

Physical condition range. The measured output should be within
Check the physical condition of the device, as 10 % of the set output. For an output setting
described in the General Equipment Procedure. of 100 mA, the measured output should be
between 90 mA and 110 mA.
Electrical safety
Perform electrical safety checks as described in
Chapter 5, Electrical Safety. Check ground wire
***IMPORTANT***
resistance, chassis leakage, and lead leakage. DO NOT TOUCH EXPOSED
CONNECTORS WHILE THE
Preventive maintenance PACEMAKER IS ON. TURN THE
PACER OFF BEFORE ADJUSTING
Replace battery: The battery should be
OR REMOVING CONNECTIONS.
replaced every 24 months. Replace if necessary.
Complete model-specific preventive main-
tenance: Refer to the monitor’s service manual Rate accuracy: While measuring pacer
for preventive maintenance tasks specific to the output, the SigmaPace 1000 also displays the
device. Complete the preventive maintenance pulse rate. The measured pulse rate should be
per manufacturer’s procedure. within 5 % of the set rate. For a rate of 80 ppm,
the pulse rate should be between 84 ppm and
Performance inspection 76 ppm. Slowly adjust the pulse rate on the
Verify unit operates on battery: Check that pacemaker and measure the pulse rate through-
the ac power indicator is lit when the power out its range.
cord is plugged into an outlet. Unplug the ac Pulse width: While measuring pacer output,
power cord and perform the remainder of the the SigmaPace 1000 will display the pulse
functional test on battery power. The ac power width. Typical pulse widths are between
indicator should go out when the power cord 0.5 mSec to 2.0 mSec. Measure the pulse
is unplugged and the battery indicator should width across its range. The measured pulse
light. Be sure to plug the power cord in at the width should be within 10 % of the set width.
conclusion of the test. For a pulse width of 2.0 mSec, the measured
Output accuracy: Connect the pacemaker pulse width should be between 1.8 mSec and
to the input jacks on the front of the analyzer. 2.2 mSec.
Power on the analyzer and press F1, ‘NONINV’, Verify operation of alarms: Simulate any
to select non-invasive pacing. Press F3, ‘BRAND’ alarm conditions. Check that all alarms are
to cycle through the available manufacturers. functional and that the volume is adequately
The preset test load will appear for each manu- loud. Ensure that appropriate visual indicators
facturer. If necessary, press F4, LOAD’, to adjust are functioning.
the test load. Refer to the pacemaker’s manual Complete model-specific performance test-
for the proper load. Press F1, ‘NEXT’, once the ing: Refer to the electrosurgical unit’s service
proper manufacturer and test load have been manual for performance inspection tasks spe-
selected. cific to the device. Complete the performance
Set the pacing rate on the pacemaker to inspection per manufacturer’s procedure.
80 ppm. Set the pacemaker output to the mini- Return to service: Before returning to use,
mum setting and start pacing. The SigmaPace return any settings that were adjusted to their
1000 will display the pacer output amplitude original settings. If equipped with a power
in mA. Measure the pacer output over its entire cord or charger, plug in to ensure the battery
remains charged and ready for use.

©University of Vermont, Rev. 2 – Confidential 79

Fetal monitor transducer. During invasive monitoring, elec-
Fetal monitors measure fetal heart rate and trodes are placed on the scalp or other exposed
maternal uterine contractions during labor to skin of the fetus to measure the fetal heart
assess the progress of labor and the health of rate. Intrauterine pressure is measured directly
the mother and fetus. Fetal monitors may use through a pressure transducer located on a
non-invasive or invasive methods for monitor- catheter that is inserted into the uterus. Fetal
ing. For non-invasive monitoring, measurements monitors may have additional monitoring capa-
are taken from transducers placed on the moth- bilities, such as maternal heart rate and blood
er’s abdomen. An ultrasound transducer is used pressure.
to measure the fetal heart rate. Uterine contrac- Recommended functional test frequency:
tions are measured using a tocodynamometer annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant History 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

80 ©University of Vermont, Rev. 2 – Confidential

 Fetal monitor procedure
Estimated time: 30 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent) Cables to connect fetal monitor to
PS320 Fetal Simulator (or equivalent) analyzer
MFH-1 Mechanical Fetal Heart (or equivalent) Stopwatch or clock with second hand
Ultrasound gel

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Replace battery every 24 months
Clean rollers and paper guides
Lubricate motor and paper drive mechanism
Verify proper time and date, correct if necessary
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Fetal heart rate accuracy ±5%
Maternal heart rate accuracy ±5%
Intrauterine pressure accuracy ±2%
Recorder speed (3 cm/min) ±4%
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 81

Physical condition Performance inspection
Check the physical condition of the device, as Verify unit operates on battery: Check that
described in the General Equipment Procedure. the ac power indicator is lit when the power
cord is plugged into an outlet. Unplug the ac
Electrical safety power cord and perform the remainder of the
Perform electrical safety checks as described in functional test on battery power. The ac power
Chapter 5, Electrical Safety. Check ground wire indicator should go out when the power cord
resistance, chassis leakage, and lead leakage. is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
Preventive maintenance conclusion of the test.
Fetal heart rate accuracy: If the fetal moni-
Replace battery: The battery should be
tor uses fetal scalp electrodes, connect the
replaced every 24 months. Replace if necessary.
ECG cable to the connectors on the side of the
Clean rollers and paper guides: Inspect the
PS320. Use the fetal up and down buttons to
rollers and paper guides and remove any debris.
set a fetal heart rate of 120 bpm. The displayed
Check for bits of torn paper caught in the rollers.
heart rate should be within 5 % of the set rate.
Lubricate motor and paper drive mecha-
For a simulated heart rate of 120 bpm, the
nism: Follow the manufacturer’s instructions
displayed rate should be between 114 bps and
in the service manual for lubricating the motor
126 bps.
and paper drive mechanism. Not all motors will
Connect the ultrasound cable from the
need to be lubricated.
ultrasound connector on the fetal monitor to
Verify proper time and date, correct if
the US1 port of the PS320. If the fetal monitor
necessary: Verify the time and date displayed
is equipped with two ultrasound inputs, con-
on the monitor is correct. If the time and date is
nect a second ultrasound cable to the US2 port
not displayed on the monitor, print a strip from
of the analyzer. As above, the displayed heart
the recorder. The time and date should appear
on the printed strip. Correct the time and date
as necessary.
Complete model-specific preventive main-
tenance: Refer to the monitor’s service manual
for preventive maintenance tasks specific to the
device. Complete the preventive maintenance
per manufacturer’s procedure.

Testing ultrasound transducers with the MFH-1 Fetal Heart Simulator.

82 ©University of Vermont, Rev. 2 – Confidential

rate should be within 5 % of the set rate. For a Recorder speed: Record a strip on the fetal
simulated heart rate of 120 bpm, the displayed monitor. Use the mark function on the recorder
rate should be between 114 bps and 126 bps. to place a mark on the paper. Use a stopwatch
Disconnect the cables from the PS320 analyzer. or clock to time 150 seconds (2.5 minutes).
To test the operation of the ultrasound trans- Place another mark on the paper. Measure the
ducers, connect the MFH-1 Fetal Heart Simulator distance between the marks. With a recorder
to the US1 port of the PS320 analyzer. The speed of 3 cm/min, the marks should be
analyzer will need to be used with the battery between 72 mm and 78 mm.
eliminator, as the MFH-1 cannot run on battery Verify operation of alarms: Check that all
power. Connect an ultrasound transducer to the alarms are functional and that the volume is
fetal monitor. Place the transducer face up on a adequately loud. Ensure that appropriate visual
flat surface and coat with ultrasound gel. Place indicators are functioning.
the MFH-1 on top of the transducer with the Note the alarm settings on the monitor. Adjust
simulation window facing the transducer. The the fetal heart rate on the PS320 down to just
fetal heart rate will be displayed on the monitor below the monitor’s low heart rate limit. The
and should be within 5 % of the set rate. For a alarm should sound. Increase the fetal heart
simulated heart rate of 120 bpm, the displayed rate above the low alarm point. Clear the alarm
rate should be between 114 bpm and 126 bpm. if necessary. Increase the fetal heart rate to just
Repeat this process for each ultrasound trans- above the high heart rate limit. Note that the
ducer. Remove the MFH-1 from the PS320. alarm sounds when the heart rate increases
Maternal heart rate accuracy: Connect the beyond the high alarm limit. Set the fetal heart
ECG cable to the connectors on the side of the rate back to 120 bpm and clear any alarms.
PS320. Use the maternal up and down buttons Repeat the process for the maternal heart rate
to set a maternal heart rate of 60 bpm. The dis- alarm.
played heart rate should be within 5 % of the Complete model-specific performance
set rate. For a simulated heart rate of 60 bpm, testing: Refer to the service manual for perfor-
the displayed rate should be between 57 bpm mance inspection tasks specific to the device.
and 63 bpm. Complete the performance inspection per
Intrauterine pressure accuracy: Connect manufacturer’s procedure.
the TOCO cable from the TOCO connector on the Return to service: Before returning to use,
fetal monitor to the TOCO port of the PS320. Use return any alarms that were adjusted to their
the TOCO button to scroll through the available original settings. Ensure the volume of the
settings. The displayed intrauterine pressure audible alarms is loud enough to be heard in
should be within 2 % of the set pressure. For normal operating conditions. Clean ultrasound
a simulated pressure of 50 mm, the displayed gel from the transducers. Plug in the power cord
pressure should be between 49 mm and 51 mm. to ensure the battery remains charged.

©University of Vermont, Rev. 2 – Confidential 83

Hypo/hyperthermia unit circulating water, and a blanket designed for
Hypo/hyperthermia units regulate a patient’s water circulation. The units will also have a
temperature using circulating water. By adjust- thermostat and circuitry for maintaining a set
ing the temperature of the water, the patient temperature.
may be either heated or cooled. These devices Recommended functional test frequency:
typically consist of a water reservoir, a heat- annual.
ing element, a cooling system, a pump for

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 11
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

84 ©University of Vermont, Rev. 2 – Confidential

 Hypo/hyperthermia unit procedure
Estimated time: 35 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
DPM 4 with temperature probe (or equivalent)
Water flow meter
Tubing and connectors to connect flow meter

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Inspect and clean reservoir
Lubricate motor
Complete model-specific preventive maintenance
Performance testing
Fluid level
Flow rate
Temperature accuracy ± 1 ºC
High temperature protection ≥ 43 ºC
Low temperature protection ≤ 1 ºC
Temperature probe accuracy ± 1 ºC
Alarms
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 85

Physical condition Flow rate: Connect a blanket to the hypo/
Check the physical condition of the device, as hyperthermia unit. Connect a water flow meter
described in the General Equipment Procedure. between the outlet of the hypo/hyperthermia
unit and the inlet of the blanket. Check the ser-
Electrical safety vice manual for flow rate specifications.
Temperature accuracy: Connect the tem-
Perform electrical safety checks as described in perature probe to the Temp connector on the
Chapter 5, Electrical Safety. Check ground wire side of the DPM 4. If the temperature units need
resistance and chassis leakage. to be changed, press the soft key labeled ‘UNIT’
on the DPM 4 and then use the menu scroll
Preventive maintenance keys until ‘C/F’ is displayed. Press the soft key
Inspect and clean reservoir: Empty the water labeled ‘C/F’ to toggle between the Celsius and
reservoir. Check for cracks and leaks. Inspect Fahrenheit scales.
the condition of rubber seals and replace as Connect a blanket to the hypo/hyperthermia
necessary. Clean any debris or mineral build up unit. Insert the temperature probe into the
from the reservoir. Refill the reservoir tank with water reservoir to measure the temperature of
distilled water. Do not fill with tap water, as the circulating water. Set the temperature of the
this may cause mineral build up in the device. hypo/hyperthermia unit to its lowest setting.
Lubricate motor: Follow the manufacturer’s Allow the water temperature to stabilize. Repeat
instructions in the service manual for lubricat- the temperature measurement with a midrange
ing the pump motor. Not all motors will need to temperature and the maximum temperature
be lubricated. setting. The measured temperature should be
Complete model-specific preventive main- within 1 °C of the set temperature. For a set
tenance: Refer to the monitor’s service manual temperature of 42 °C, the measured temperature
for preventive maintenance tasks specific to the should be between 41 °C and 43 °C.
device. Complete the preventive maintenance
per manufacturer’s procedure.

Performance inspection
Fluid level: Ensure there is an adequate water
level in the reservoir. There should be sufficient
water for circulating throughout the blanket, but
the water reservoir should not be overfilled.

Testing water temperature with the DPM 4.

86 ©University of Vermont, Rev. 2 – Confidential

 High temperature protection: Connect a If the hypo/hyperthermia is not equipped
blanket to the hypo/hyperthermia unit and with a patient temperature probe, follow the
insert the temperature probe into the water manufacturer’s procedure for overriding the
reservoir. Set the temperature on the hypo/ thermostat.
hyperthermia unit to its maximum setting. Temperature probe accuracy: Fill a con-
If the hypo/hyperthermia unit is equipped tainer with warm water at about 30 °C. Insert
with a patient temperature probe, expose the the temperature probe from the hypo/hyper-
temperature probe to room air. The temperature thermia unit and the temperature probe from
of the circulating water should increase until the the DPM 4 into the water. The temperature dis-
hypo/hyperthermia unit alarms temperature. played on the hypo/hyperthermia unit should
Note the temperature at which the alarm sounds be within 1 °C of the temperature measured
on the DPM 4. Check the service manual for the on the DPM 4. For a temperature of 30 °C, the
specific high temperature limit and compare this displayed temperature should be between 29 °C
value with the measured temperature. The mea- and 31 °C.
sured temperature should be within 1 °C of the Alarm function: Check that all alarms are
high temperature limit. For a high temperature functional and that the volume is adequately
limit of 44 °C, the measured high temperature loud. Ensure that appropriate visual indicators
should be between 43 °C and 45 °C. are functioning.
If the hypo/hyperthermia is not equipped If the hypo/hyperthermia unit is equipped
with a patient temperature probe, follow the with a low reservoir alarm, drain the reservoir
manufacturer’s procedure for overriding the to below the low water level. Run the hypo/
thermostat. hyperthermia unit. The low reservoir alarm
Low temperature protection: If the hypo/ should sound. Fill the reservoir with distilled
hyperthermia unit is equipped with a low water until the alarm clears.
temperature alarm, set the temperature on the Complete model-specific performance
hypo/hyperthermia unit to its lowest setting. testing: Refer to the service manual for perfor-
If the hypo/hyperthermia unit is equipped mance inspection tasks specific to the device.
with a patient temperature probe, expose the Complete the performance inspection per
temperature probe to room air. The temperature manufacturer’s procedure.
of the circulating water should decrease until Return to service: Before returning to use,
the hypo/hyperthermia unit alarms low temper- return any settings that were adjusted to their
ature. Note the temperature at which the alarm original settings. Ensure the volume of the
sounds on the DPM 4. Check the service manual audible alarms is loud enough to be heard in
for the specific low temperature limit and com- normal operating conditions. If the hypo/hyper-
pare this value with the measured temperature. thermia unit is going to be used in the near
The measured temperature should be within future, Ensure there is an adequate water level
1 °C of the low temperature limit. in the reservoir. If the hypo/hyperthermia unit
will not be used soon, drain the water from the
reservoir.

©University of Vermont, Rev. 2 – Confidential 87

Infant incubator circulating warm air, and temperature controls.
Infant incubators provide a closed controlled Temperature sensors may measure air tem-
environment to maintain appropriate tempera- perature inside the incubator, the infant’s body
ture, humidity, and oxygen levels for infants temperature through a skin probe, or both. Most
and are used mainly for premature infants incubators also include humidity controls and a
and other newborns that cannot regulate their means for adjusting oxygen levels.
body temperature by themselves. Infant incu- Recommended functional test frequency:
bators typically consist of a clear removable annual.
plastic hood with a mattress, a heater, a fan for

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

88 ©University of Vermont, Rev. 2 – Confidential

 Infant incubator procedure
Estimated time: 120 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
INCU incubator analyzer (or equivalent)
Stopwatch or watch with a second hand
Heat Gun

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean cooling vents and filters
Inspect and clean ducts, heater, and fans
Inspect gaskets for signs of deterioration
Inspect port closures and port sleeves
Replace battery every 24 months
Complete model-specific preventive maintenance

continued on page 90

©University of Vermont, Rev. 2 – Confidential 89

 Infant incubator procedure
Estimated time: 120 minutes

continued from page 89

Test Result
Pass Fail N/A
Performance testing
Verify unit operates on battery
Fan operation
Warm up time ± 20 %
Air temperature accuracy ± 1 ºC
Skin temperature accuracy ± 0.3 ºC
Temperature overshoot ± 2 ºC
Relative humidity ± 10 %
Air flow ≤ 0.35 m/s
Air temperature alarms
Skin temperature alarms
High temperature protection ≤ 40 °C
Noise level ≤ 60 dB normal conditions
≤ 80 dB alarm activated
≥ 80 dB alarm activated,
3 m from incubator
Alarm function
Complete model-specific performance testing

90 ©University of Vermont, Rev. 2 – Confidential

Physical condition Replace battery: The battery should be
Check the physical condition of the device, as replaced every 24 months. Replace if necessary.
described in the General Equipment Procedure. Complete model-specific preventive main-
tenance: Refer to the monitor’s service manual
Electrical safety for preventive maintenance tasks specific to the
device. Complete the preventive maintenance
Perform electrical safety checks as described in per manufacturer’s procedure.
Chapter 5, Electrical Safety. Check ground wire
resistance and chassis leakage. Performance inspection
Preventive maintenance Verify unit operates on battery: Check that
the ac power indicator is lit when the power
Clean cooling vents and filters: Inspect vents cord is plugged into an outlet. Unplug the ac
and air filters. Use a portable vacuum to clean power cord and perform the remainder of the
dust from air ducts. Clean or replace filters functional test on battery power. The ac power
as necessary. Ensure that filters are installed indicator should go out when the power cord
properly. is unplugged and the battery indicator should
Inspect gaskets for signs of deterioration: light. Be sure to plug the power cord in at the
Check rubber or plastic gaskets and seals for conclusion of the test.
signs of deterioration. Replace as necessary. Fan operation: Inspect the fan blades for
Inspect port closures and port sleeves: damage. Look for chips, warping, melting, and
Inspect port doors and iris seals for proper missing blades. Ensure there is adequate clear-
closure. Inspect the port gloves for holes or ance around the fan assembly. Look for signs of
other signs of wear. rubbing around the fan housing. Lubricate the
fan motor per the manufacturer’s specification.
Follow the manufacturer’s instructions in the
service manual for lubricating the pump motor.
Not all motors will need to be lubricated.
Warm-up time: With the incubator at room
temperature, set the incubator temperature for
12 ºC above ambient temperature (typically
36 ºC). Use a stopwatch to time how long it
takes for the temperature to stabilize. The mea-
sured warm-up time should be within 20 % of
the manufacturer’s specified warm-up time. For
a warm-up time of 30 minutes, the measured
warm up time should be within 24 minutes and
36 minutes.

INCU inside incubator.

©University of Vermont, Rev. 2 – Confidential 91

 Air temperature accuracy: Set the incuba- more than 2 ºC. For a set temperature of 36 ºC,
tor temperature to 32 ºC. Place the INCU in the the incubator temperature should not exceed
center of the incubator. Place the T1 and T3 38 ºC during temperature stabilization.
temperature probes so that they are placed ver- Relative humidity: If the incubator is
tically in opposite corners. Place the T2 probe in equipped with a display for relative humid-
the center holder. Attach the air flow sensor and ity, note the relative humidity measured on the
rotate the sensor so that it is perpendicular to INCU. The measured relative humidity should be
the air flow within the incubator. If the incuba- within 10 % of the displayed relative humidity.
tor is equipped with a skin temperature probe, For a displayed relative humidity of 50 %, the
place the skin probe in close proximity to the measured relative humidity should be between
T2 sensor. Allow the incubator temperature to 45 % and 55 %.
stabilize. Press the ‘SELECT’ button on the INCU Air flow: With the INCU placed in the center
to cycle through the readings. The measured of the incubator, rotate the air flow sensor so
air temperature should be within 1 ºC of the set that it is perpendicular with the airflow in the
temperature. For a set temperature of 32 ºC the incubator. Note the air velocity measurement
measured temperature should be between 31 ºC on the INCU. The air velocity should not exceed
and 33 ºC. 0.35 m/s.
Set the temperature on the incubator to 36 ºC Air temperature alarms: Set the incubator
and allow the temperature to stabilize. Repeat temperature to 36 ºC and allow the tempera-
the temperature measurements at 36 ºC. ture to stabilize. Open the incubator hood to
Skin temperature accuracy: Place the skin room air. Verify that the low temperature alarm
temperature probe in close proximity to the T2 sounds. Close the incubator and allow the tem-
sensor on the INCU. Allow the incubator tem- perature to stabilize at 36 ºC. Use a heat gun to
perature to stabilize. The measured temperature increase the air temperature. Note the tempera-
on the T2 sensor should be within 0.3 ºC of the ture at which the alarm sounds.
displayed skin temperature on the incubator.
For a displayed skin temperature of 36.0 ºC,
the measured temperature should be between
35.7 ºC and 36.3 ºC.
Temperature overshoot: From a stabilized
incubator temperature of 32 ºC, increase the
incubator temperature to 36 ºC. Allow the
temperature to stabilize. During temperature
stabilization, the temperature in the incubator
should not overshoot the set temperature by

***CAUTION***
DO NOT USE THE AIR FLOW SENSOR IN
THE PRESENCE OF OXYGEN. THE SENSOR
USES A HOT-WIRE TECHNIQUE FOR AIR
VELOCITY MEASUREMENT AND MAY
BECOME A SOURCE OF IGNITION.

Placement of air flow sensor.

92 ©University of Vermont, Rev. 2 – Confidential

 Skin temperature alarms: Adjust the skin Alarm function: Check that all alarms are
temperature set point on the incubator to 36 functional and that the volume is adequately
ºC. Place the sensor in the incubator and allow loud. Ensure that appropriate visual indicators
the temperature to stabilize. Remove the skin are functioning.
temperature sensor from the incubator and Unplug the temperature probe from the incu-
verify that the low temperature alarm sounds. bator. The disconnected probe alarm should
Place the skin temperature sensor in a cup of activate. If the incubator is equipped with
warm water. Ensure the water is warm enough alarms for an open or short circuited tempera-
to activate the high temperature alarm. ture probe, use open and short circuited probe
High temperature protection: Set the incu- plugs to test these alarms. Disconnect the skin
bator temperature to its maximum setting and temperature probe and connect the probe plugs.
allow the temperature to stabilize. Use a heat The appropriate alarms should activate.
gun to blow hot air into the incubator to raise Unplug the incubator to simulate a power fail-
the temperature above the maximum setting. ure. The power failure alarm should activate.
Note the temperature at which the over tem- Complete model-specific performance
perature alarm activates. testing: Refer to the service manual for perfor-
Noise level: With the incubator running and mance inspection tasks specific to the device.
the INCU placed in the center of the incubator, Complete the performance inspection per
measure the sound level inside the incubator. manufacturer’s procedure.
Press the ‘SELECT’ button on the INCU to cycle Return to service: Before returning to use,
through the measurements until the sound return any settings that were adjusted to their
level is displayed. All ports and doors should be original settings. Ensure the volume of the
closed for this measurement. The sound level audible alarms is loud enough to be heard in
within the incubator should not exceed 60 dB. normal operating conditions. Plug in the power
The most common cause of high sound levels in cord to ensure the battery remains charged.
the incubator is a noisy fan assembly. Activate
an alarm. The sound level in the incubator with
the alarm sounding should not exceed 80 dB.
Remove the INCU from the incubator and
place it 3 m from the front of the incubator.
Activate an alarm on the incubator and mea-
sure the sound level with the INCU. The alarm
should be at least 80 dB at this distance.

©University of Vermont, Rev. 2 – Confidential 93

Infusion pump for propelling the infusate. Adjustable settings
Infusion pumps deliver controlled and accu- control the flow rate and volume to be infused.
rate infusion of liquids to a patient through Audible and visual alarms alert the user to flow
intravenous, epidural, or subcutaneous routes. changes or malfunctions. Most infusion pumps
These pumps may utilize a peristaltic pump include a memory function that records does
mechanism, a volumetric pump mechanism that settings and alarms.
repeatedly compresses a specific amount of fluid Recommended functional test frequency:
into a cassette, or a syringe driven mechanism annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

94 ©University of Vermont, Rev. 2 – Confidential

 Infusion pump procedure
Estimated time: 45 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent) Tubing set for infusion pump
IDA 4 Plus Infusion Device Analyzer (or equivalent) 20 cc or larger syringe
Reservoir to connect to tubing set (bag or bottle) 3 way stopcock
Tubing and connectors to connect to IDA 4 Plus

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean flow detector
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Pole clamp function
Flow rate accuracy ± 10 %
Volume accuracy ± 10 %
Infusion complete/KVO
Occlusion detection pressure ± 1 psi
Piggyback infusion
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 95

Physical condition Flow rate accuracy: Fill the infusion reser-
Check the physical condition of the device, as voir with a 1 % detergent solution in de-ionized
described in the General Equipment Procedure. water. A 1 % stock solution of detergent such
as Cole-Parmer Micro-90 should be prepared
Electrical safety in volume using de-ionized water; this may be
stored in a closed vessel for up to 6 months.
Perform electrical safety checks as described in The solution should then be diluted 10:1 with
Chapter 5, Electrical Safety. Check ground wire de-ionized water for daily use. If the water used
resistance and chassis leakage. causes too much foaming, a 20:1 dilution is
recommended. Do not use tap water or solutions
Preventive maintenance intended for patient use, as these may harm the
Clean flow detector: Inspect the flow detector transducers in the IDA 4 Plus.
on the infusion pump. Clean any debris from Connect the infusion tubing to the reser-
the flow sensor. voir. Prime the set so that there is no air in
Replace battery: The battery should be the tubing. With the tubing draining into a
replaced every 24 months. Replace if necessary. container or sink, open the flow control mecha-
Complete model-specific preventive main- nism on the tubing set. Hold the reservoir high
tenance: Refer to the monitor’s service manual enough above the tubing so that fluid flows
for preventive maintenance tasks specific to the through the tubing under the force of gravity.
device. Complete the preventive maintenance Allow fluid to flow through the tubing until no
per manufacturer’s procedure. air bubbles can be seen in the tubing. Insert the
set into the infusion pump. Connect the three-
Performance inspection way stopcock to the channel 1 port on the IDA
Verify unit operates on battery: Check that 4 Plus. Connect the patient infusion tubing to
the ac power indicator is lit when the power one port of the stopcock. Fill the syringe with
cord is plugged into an outlet. Unplug the ac the detergent solution and connect this to the
power cord and perform the remainder of the other port of the stopcock. Connect a piece of
functional test on battery power. The ac power tubing to the drain port of channel 1 and run
indicator should go out when the power cord the tubing into a container to catch the used
is unplugged and the battery indicator should solution.
light. Be sure to plug the power cord in at the
conclusion of the test.
Pole clamp function: Check the physical
condition of the pole clamp. The pole clamp
should be securely fastened to the infusion
pump. The clamp mechanism should move
freely. The pole clamp should secure the infu-
sion pump to the IV pole.

Infusion pump connected to the IDA 4 Plus.

96 ©University of Vermont, Rev. 2 – Confidential

 From the main menu of the IDA 4 Plus, use Set up the infusion pump with a high flow
the arrow keys to highlight ‘SETUP’ under rate and low volume, such as 300 mL/hr and
channel 1 and then press ‘ENT’. Use the arrow 2 mL. Start the pump and allow the infusion to
keys to highlight ‘FLOW’ and press ‘ENT’. Select complete. When the infusion is complete, do not
‘PRIME’. Close the stopcock port connected to stop the pump, instead silence the alarm and
the infusion tubing, leaving the ports to the let the pump run. Enter the ‘FLOW’ screen on
syringe and the IDA 4 Plus open. Inject the the IDA 4 Plus to measure the KVO rate. Several
solution in the syringe into the IDA 4 Plus until minutes may be required for the analyzer to be
‘START’ appears on the screen. Select ‘Auto- able to measure the low rate. The measured
START’. The IDA 4 Plus will start the flow test rate should be within 10 % of the infusion
when it detects flow from the pump. Close the pump’s KVO rate. For a KVO rate of 1 mL/hr, the
port to the syringe, leaving the ports to the measured rate should be between 0.9 mL/hr
tubing and the IDA 4 Plus open. and 1.1 mL/hr.
Set the flow rate on the infusion pump to Occlusion detection pressure: From the
60 mL/hr and set the dose to 10 mL. Start the channel set up menu on the IDA 4 Plus, select
infusion pump. When the pump alarms com- ‘OCCLUSION’. Prime the IDA 4 Plus with the
plete, select ‘END’ on the IDA 4 Plus to end the syringe if necessary. Set the flow rate on the
test. At the set rate and volume, the dose should infusion pump to 100 mL/hr. Set the volume to
be complete in approximately 10 minutes. Clear 10 mL or more so that the volume will not be
the alarm on the pump. The measured flow delivered before the test is complete. Start the
rate should be within 10 % of the set rate. For pump. Select ‘START’ on the IDA 4 Plus. Select
a flow rate of 60 mL/hr, the flow rate should be ‘END’ on the IDA 4 Plus when the pump alarms
between 54 mL/hr and 66 mL/hr. Set the flow occlusion. Note the pressure at which the pump
rate on the pump to 120 mL/hr and the dose alarms. Compare the measured pressure to the
to 10 mL. Repeat the flow test at the higher occlusion pressure of the pump. The occlusion
flow rate. pressure will be specific to the model. Check
The IDA 4 Plus is equipped with four chan- the service manual for the specific pressure.
nels to analyze infusion devices. Four pumps The measured occlusion pressure should be
can be run simultaneously. within 1 psi of the pump’s occlusion pressure.
Volume accuracy: Set up the infusion pump For an occlusion pressure of 20 psi, the mea-
and the IDA 4 Plus as described previously in sured pressure should be between 19 psi and
Flow Rate Accuracy. The IDA 4 Plus will mea- 21 psi.
sure flow rate and volume simultaneously. The Piggyback infusion: From the channel set
delivered volume should be within 10 % of the up menu on the ID A4 Plus, select ‘DUAL FLOW’.
set volume. For a set volume of 10 mL, the mea- Prime the IDA 4 Plus with the syringe if neces-
sured volume should be within 9 mL and 11 mL. sary. Use the arrow keys to enter the flow rates
Infusion complete/KVO: At the conclusion and volumes to be tested. Enter 60 mL/hr for the
of an infusion, the infusion pump should alarm secondary rate, 10 mL for the secondary volume,
‘infusion complete’ or ‘KVO’. If the pump alarms 12 0mL/hr for the primary rate, and 10 mL
‘KVO’ it is supplying a very low flow rate in for the primary volume. Select ‘AutoSTART’ to
order to keep the vein open if another infusion start the flow measurements when flow is first
needs to be given. Measure the KVO rate using detected.
the ‘FLOW’ function on the IDA 4 Plus.

©University of Vermont, Rev. 2 – Confidential 97

 On the infusion pump, set the primary rate for If the pump is equipped with an air detector,
120 mL/hr and the primary volume to 10 mL. introduce air into the tubing. Turn the reser-
Set the piggyback flow rate to 60 mL/hr and the voir upside down until a bubble of air is pulled
piggyback volume to 10 mL. Start the piggyback through the tubing. Turn the reservoir right side
infusion. up. When the air bubble gets to the pump, the
The IDA 4 Plus will display the rate and pump should alarm air in line. Clear the alarm.
volume for the piggyback infusion as ‘FLOW 1’. Remove the tubing from the pump and prime
When the piggyback infusion is completed, the the set so that there is no air in the tubing.
infusion pump should automatically switch over Reinsert the tubing set into the pump and
to the primary infusion, and will usually sound restart the pump.
an audible tone. The rate and volume for the Simulate an empty container situation either
primary infusion is displayed on the IDA 4 Plus by turning the reservoir upside down so that
as ‘FLOW 2’. The delivered flow rates and vol- no fluid can get to the tubing, or by removing
umes should be within 10 % of their set rates. the tubing from the reservoir. The pump should
Alarm function: Check that all alarms are alarm when no fluid flow is detected.
functional and that the volume is adequately Complete model-specific performance
loud. Ensure that appropriate visual indicators testing: Refer to the service manual for perfor-
are functioning. mance inspection tasks specific to the device.
Set the rate on the pump to 100 mL/hr and Complete the performance inspection per
set the volume to 100 mL. Start the pump. manufacturer’s procedure.
Occlude the tubing between the reservoir and Return to service: Before returning to use,
the pump. The tubing can be occluded either return any settings that were adjusted to their
by closing a clamp attached to the tubing or original settings. Ensure the volume of the
by pinching the tubing with a set of hemostats audible alarms is loud enough to be heard in
or pliers. The pump should alarm upstream normal operating conditions. Plug in the power
occlusion. cord to ensure the battery remains charged.
Clear the alarm and restart the pump. Occlude
the tubing downstream from the pump. The
pump should alarm downstream occlusion.
Clear the alarm.

98 ©University of Vermont, Rev. 2 – Confidential

 Non-invasive blood pressure monitor the cuff is deflated, transducers measure pres-
A non-invasive blood pressure (NIBP) monitor sure fluctuations. The monitor then processes
measures and displays blood pressure using the information from the pressure transducers
external sensors. These devices consist of an and displays the systolic, diastolic, and mean
inflatable cuff, hose, pressure sensors, proces- pressure, typically in mmHg (millimeters of
sor, and a display. Typically, NIBP monitors mercury). Most NIBP monitors will also display
use an oscillometric method to measure blood heart rate.
pressure. The cuff is attached to a patient’s arm Recommended functional test frequency:
and then inflated until blood flow is stopped. As annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 99

 Non-invasive blood pressure
monitor procedure
Estimated time: 25 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)  BP Pump2 NIBP Analyzer (or equivalent)
Stopwatch or watch with a second hand      PVC pipe to attach tourniquet cuff to
Tubing and connectors to connect to DPM 4

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC, < 500 µA SFC
Patient leakage current < 100 µA B and BF, < 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF, < 10 µA CF
(mains on patient applied part)
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Check condition of tubing, cuffs, and hoses
Clean recorder paper compartment, rollers and paper guides
Lubricate motor and paper drive mechanism
Verify proper time and date, correct if necessary
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Leak test ≤ 15 mmHg/min
Static pressure accuracy ± 3 mmHg
Pressure relief test ≤ 330 mmHg
Dynamic pressure accuracy ± 10 mmHg
Heart rate accuracy ±5%
Auto interval time ± 10 %
Stop/Cancel/Deflate ≤ 10 sec
Recorder operation
Alarm function
Complete model-specific performance testing

100 ©University of Vermont, Rev. 2 – Confidential

Physical condition Complete model-specific preventive main-
Check the physical condition of the device, as tenance: Refer to the monitor’s service manual
described in the General Equipment Procedure. for preventive maintenance tasks specific to the
device. Complete the preventive maintenance
Electrical safety per manufacturer’s procedure.
Perform electrical safety checks as described in Performance inspection
Chapter 5, Electrical Safety. Check ground wire
resistance and chassis leakage. Verify unit operates on battery: Check that
the ac power indicator is lit when the power
Preventive maintenance cord is plugged into an outlet. Unplug the ac
power cord and perform the remainder of the
Check condition of tubing, cuffs, and hoses: functional test on battery power. The ac power
Inspect hoses and cuffs for signs of wear. Look indicator should go out when the power cord
for holes, cracks, and dry rot. Ensure that all is unplugged and the battery indicator should
connections are secure. light. Be sure to plug the power cord in at the
Clean recorder paper compartment, roll- conclusion of the test.
ers, and paper guides: Inspect the rollers and Leak test: Connect a hose and cuff to the
paper guides and remove any debris. Check for NIBP monitor. Place the cuff around a piece of
bits of torn paper caught in the rollers. PVC pipe or other sturdy cylindrical object to
Lubricate motor and paper drive mecha- simulate placement on a limb. Connect a piece
nism: Follow the manufacturer’s instructions of tubing to the pressure port on the BP Pump 2.
in the service manual for lubricating the motor Connect a tee to this tubing and attach tubing
and paper drive mechanism. Not all motors will and connectors. Connect the two legs of the
need to be lubricated. tee between the hose and the cuff of the NIBP
Verify proper time and date. Correct if nec- monitor.
essary: Verify that the time and date displayed Place the NIBP monitor in service mode to
on the monitor is correct. If the time and date is perform the leak test. Select ‘LEAK TEST’ on the
not displayed on the monitor, print a strip from BP Pump 2. Press ‘SETUP’ to change the test
the recorder. The time and date should appear pressure set point. Use the number keys to enter
on the printed strip. Correct the time and date a test pressure of 250 mmHg and then press
as necessary. ‘ENT’. Press the soft key labeled ‘START’ on the
Replace battery: The battery should be analyzer to start the test. Allow the test to run
replaced every 24 months. Replace if necessary. for at least 30 seconds and then press the soft
key labeled ‘STOP’ to end the test. The leak rate
should be less than 15 mmHg/min.
Static pressure accuracy: With the NIBP
monitor in service mode, select ‘Static Pressure’
on the BP Pump 2. Press the soft key labeled
‘SOURCE’. Set the test pressure on the analyzer
to 200 mmHg. Start the test by pressing the
soft key labeled ‘START’. Compare the pressure
displayed on the NIBP monitor with the mea-
sured pressure displayed on the analyzer. The
measured pressure should be within 3 mmHg of
the displayed pressure. For displayed pressure
of 200 mmHg, the measured pressure should be
between 197 mmHg and 203 mmHg.
Testing a NIBP monitor with the BP Pump 2.

©University of Vermont, Rev. 2 – Confidential 101

 Pressure relief test: Place the NIBP monitor Recorder operation: After taking some blood
into service mode. Select ‘PRESSURE RELIEF’ pressure measurements, print the results with
on the BP Pump 2 and set the test pressure to the recorder. Ensure the recorder prints clearly
380 mmHg. Press the soft key labeled ‘START’ and legibly. If the date and time is present on
to start the test. Once the high-pressure relief the recorded strip, Ensure the date and time is
valve is triggered on the NIBP monitor, the moni- accurate.
Alarm function: Check that all alarms are
tor will vent the pressure from the cuff. Note the
functional and that the volume is adequately
pressure at which the relief valve is triggered. loud. Ensure that appropriate visual indicators
The over pressure limit should be less than are functioning.
330 mmHg. Check the service manual for the Select ‘STANDARD BP’ on the BP Pump 2.
exact value. Press the soft key labeled ‘OPTIONS’ on the BP
Dynamic pressure accuracy: Place the NIBP Pump 2 and set the simulated blood pressure to
monitor into the normal operating mode. Select 200/155 mmHg. Set the high alarm limits on the
‘STANDARD BP’ on the BP Pump 2. Press the NIBP monitor lower than the simulated pres-
soft key labeled ‘OPTIONS’ on the BP Pump 2 to sures. Set the high systolic alarm to 195 mmHg,
cycle through the available preset blood pressure the high diastolic alarm to 150 mmHg, the high
simulations. Select a blood pressure of 120/80 on mean pressure alarm to 160 mmHg, and the high
the analyzer. heart rate alarm to 75 bpm. Initiate a blood pres-
Initiate a blood pressure measurement on the sure measurement on the NIBP monitor. The high
NIBP monitor. The displayed pressure should be alarms should activate.
within 10 mmHg of the set pressure. For a set If the high heart rate alarm was unable to be
blood pressure of 120/80, the systolic pressure set at a low enough value, set the alarm for its
should be between 110 mmHg and 130 mmHg lowest value. Select ‘PATIENT CONDITIONS’ on
and the diastolic pressure should be between the BP Pump 2. Use the ‘OPTIONS’ soft key to
70 mmHg and 90 mmHg. Repeat the measure- cycle through the available simulations until the
ments for a blood pressure of 200/150 and a heart rate is high enough. The ‘MILD EXERCISE’
blood pressure of 80/50. simulation has a heart rate of 120 bpm.
Heart rate accuracy: With the NIBP monitor Clear the alarms on the NIBP monitor and
in normal operating mode, select ‘STANDARD BP’ return the alarm limits to their original settings.
on the BP Pump 2. Set the simulated blood pres- Select ‘STANDARD BP’ on the BP Pump 2 and
sure to 120/80. The simulated heart rate will be set the simulated blood pressure to 60/30. Set
80 bpm. Initiate a blood pressure measurement the low alarm limits on the NIBP monitor higher
on the NIBP monitor. The displayed heart rate
than the simulated pressures. Set the low sys-
should be within 5 % of the set heart rate. For
a simulated heart rate of 80 bpm, the displayed tolic alarm to 65 mmHg, the low diastolic alarm
heart rate should be between 76 bpm and to 35 mmHg, the low mean pressure alarm to
84 bpm. 45 mmHg, and the low heart rate alarm to
Auto interval time: Select a standard blood 85 bpm. Initiate a blood pressure measurement
pressure on the BP Pump 2 of 120/80. Put the on the NIBP monitor. The high alarms should
NIBP into automatic mode with an interval of activate.
5 minutes. Use a stopwatch or a watch with Complete model-specific performance test-
a second hand to measure the length of time ing: Refer to the service manual for performance
between BP measurements. The measured time inspection tasks specific to the device. Complete
should be within 10 % of the set interval. For a the performance inspection per manufacturer’s
set interval of 5 minutes, the measured interval
procedure.
should be between 4 minutes 30 seconds and
5 minutes 30 seconds. Return to service: Before returning to use,
Stop/Cancel/Deflate: Initiate a blood pressure return any settings that were adjusted to their
measurement on the NIBP monitor. Allow the cuff original settings. Ensure the volume of the
to inflate. Stop the measurement on the monitor. audible alarms is loud enough to be heard in
The cuff should deflate in less than 10 seconds. normal operating conditions. Plug in the power
cord to ensure the battery remains charged.

102 ©University of Vermont, Rev. 2 – Confidential

 Patient monitor parameters are able to be measured, and a
Patient monitors measure and display physi- single model may have several possible config-
ologic parameters reflecting a patient’s clinical urations. Most commonly these monitors display
condition. These monitors may sometimes be at least ECG waveforms, SpO2, and blood pres-
referred to as vital signs monitors. Patient moni- sure. Each component of the monitor should be
tors contain circuitry to acquire and process tested to Ensure the device is accurate.
information from physiological sensors, such Recommended functional test frequency:
as electrodes, catheters, and transducers. The annual.
monitors are usually customizable as to what

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 103

 Patient monitor procedure
Estimated time: 50 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
BP Pump 2 NIBP Analyzer (or equivalent)
Index 2 SpO2 Analyzer (or equivalent)
Stopwatch or watch with a second hand
Cables to connect to MPS450
Tubing and connectors to connect to BP Pump 2
PVC pipe to attach BP cuff to
Gas with a known quantity of CO2

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW

continued on page 105

104 ©University of Vermont, Rev. 2 – Confidential

 Patient monitor procedure
Estimated time: 50 minutes

continued from page 104

Test Result
Pass Fail N/A
Preventive maintenance
Check condition of tubing, cuffs, and hoses
Clean recorder paper compartment, rollers and paper guides
Lubricate motor and paper drive mechanism
Verify proper time and date, correct if necessary
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Heart rate accuracy ±5%
Amplitude accuracy ±5%
Recorder speed ±4%
Respiration rate accuracy ±5%
Leak test ≤ 15 mmHg/min
Static pressure accuracy ± 3 mmHg
Pressure relief test ≤ 330 mmHg
Dynamic pressure accuracy ± 10 mmHg
Auto interval time ± 10 %
Stop/Cancel/Deflate ≤ 10 sec
SpO2 accuracy ±3%
Invasive pressure accuracy ±5%
Temperature accuracy ± 0.3 C
Carbon dioxide concentration accuracy ± 0.4 vol %
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 105

Physical condition is unplugged and the battery indicator should
Check the physical condition of the device, as light. Be sure to plug the power cord in at the
described in the General Equipment Procedure. conclusion of the test.
Heart rate accuracy: Connect the patient
Electrical safety leads to the lead connectors on the MPS450.
Set the heart rate on the MPS450 to 60 bpm.
Perform electrical safety checks as described in Press ‘1’ (‘NSR’), and then use the soft keys
Chapter 5, Electrical Safety. Check ground wire marked ‘UP’ and ‘DOWN’ to change the heart
resistance and chassis leakage. rate to 60 bpm.
The heart rate should be within 5 % of the
Preventive maintenance set rate. For a simulated heart rate of 60 bpm,
Check condition of tubing, cuffs, and hoses: the displayed rate should be between 57 bpm
Inspect hoses and cuffs for signs of wear. Look and 63 bpm. Set the heart rate on the MPS450
for holes, cracks, and dry rot. Ensure that all to 120 bpm. The displayed heart rate should be
connections are secure. between 114 bpm and 126 bpm.
Clean recorder paper compartment, roll- Amplitude accuracy: With the patient leads
ers, and paper guides: Inspect the rollers and connected to the MPS450, input a normal
paper guides and remove any debris. Check for sinus rhythm by pressing ‘1’ (‘NSR’). Press the
bits of torn paper caught in the rollers. soft key marked ‘SEL’ to select AMPL. Use the
Lubricate motor and paper drive mecha- soft keys marked up and down to change the
nism: Follow the manufacturer’s instructions amplitude to 1.0 mV. Set the sensitivity on the
in the service manual for lubricating the motor electrocardiograph to 20 mm/mV. Record a strip
and paper drive mechanism. Not all motors will on the electrocardiograph.
need to be lubricated. Measure the height of the QRS peak. The
Verify proper time and date. Correct if nec- measured amplitude should be within 5 % of
essary: Verify that the time and date displayed the set amplitude. For an amplitude setting of
on the monitor is correct. If the time and date is 1 mV and a sensitivity of 20 mm/mV, the peak
not displayed on the monitor, print a strip from should be between 19 mm and 21 mm.
the recorder. The time and date should appear Heart rate alarms: Set the high heart rate
on the printed strip. Correct the time and date alarm on the monitor to 120 bpm. Set the low
as necessary. heart rate alarm on the monitor to 40 bpm.
Replace battery: The battery should be Adjust the heart rate on the MPS450 to
replaced every 24 months. Replace if necessary. 140 bpm. The high rate alarm should activate.
Complete model-specific preventive main- Return the heart rate on the MPS450 to
tenance: Refer to the monitor’s service manual 60 bpm and clear the alarm. Adjust the heart
for preventive maintenance tasks specific to the rate on the MPS450 to 30 bpm. The low rate
device. Complete the preventive maintenance alarm should activate. Return the heart rate on
per manufacturer’s procedure. the MPS450 to 60 bpm and clear the alarm.
Return the alarm limits on the monitor to their
Performance inspection original settings.
Verify unit operates on battery: Check that Recorder speed: Set the heart rate on the
the ac power indicator is lit when the power MPS450 to 60 bpm. Record a strip on the elec-
cord is plugged into an outlet. Unplug the ac trocardiograph. Measure the distance between
power cord and perform the remainder of the the peaks of the QRS complex. With a recorder
functional test on battery power. The ac power speed of 25 mm/sec, the QRS peaks should be
indicator should go out when the power cord between 24 mm and 26 mm apart.

106 ©University of Vermont, Rev. 2 – Confidential

 Respiration rate accuracy: Set the respira- analyzer to start the test. Allow the test to run
tion rate on the MPS450 to 20 breaths/min. for at least 30 seconds and then press the soft
Press ‘2’ (‘RESP’) and then use the soft keys key labeled ‘STOP’ to end the test. The leak rate
to change the respiration rate. The respiration should be less than 15 mmHg/min.
rate should be within 5 % of the set rate. For a Static pressure accuracy: With the NIBP
simulated respiration rate of 20 breaths/min, monitor in service mode, select ‘STATICPres-
the displayed rate should be between sure’ on the BP Pump2. Press the soft key
19 breaths/min and 21 breaths/min. labeled ‘SOURCE’. Set the test pressure on the
Respiration alarms: Set the high respiration analyzer to 200 mmHg. Start the test by press-
rate alarm on the monitor to 60 breaths/min. ing the soft key labeled ‘START’. Compare the
Set the low respiration rate alarm on the moni- pressure displayed on the NIBP monitor with
tor to 20 bpm. Adjust the respiration rate on the the measured pressure displayed on the ana-
MPS450 to 80 breaths/min. The high rate alarm lyzer. The measured pressure should be within
should activate. Bring down the respiration rate 3 mmHg of the displayed pressure. For dis-
on the MPS450 to 30 breaths/min and clear played pressure of 200 mmHg, the measured
the alarm. Adjust the respiration rate on the pressure should be between 197 mmHg and
MPS450 to 15 bpm. The low rate alarm should 203 mmHg.
activate. Bring down the respiration rate on the Pressure relief test: Put the NIBP monitor
MPS450 to 20 breaths/min and clear the alarm. into service mode. Select ‘PRESSURE RELIEF’
Return the alarm limits on the monitor to their on the BP Pump 2 and set the test pressure to
original settings. 380 mmHg. Press the soft key labeled ‘START’
To simulate an apnea condition, press the soft to start the test. The test will end when the
key button ‘APNE’. Use the soft keys marked high-pressure relief valve is triggered on the
‘PREV’ and ‘NEXT’ to cycle through the apnea NIBP monitor and the monitor vents the pres-
durations and select ‘CONTINUOS’. Press the sure from the cuff. Note the pressure at which
soft key labeled ‘RUN’ to start the apnea condi- the relief valve is triggered. The over pressure
tion. To stop the apnea condition and return to limit should be less than 330 mmHg. Check the
normal respiration, press the soft key labeled manufacturer’s service manual for the exact
‘STOP’. The alarm should sound for an apnea value.
condition. Most monitors will alarm within Dynamic pressure accuracy: Place the NIBP
30 seconds. monitor into the normal operating mode. Select
Leak test: Connect a hose and cuff to the ‘STANDARD BP’ on the BP Pump 2. Press the
NIBP monitor. Place the cuff around a piece of soft key labeled ‘OPTIONS’ on the BP Pump 2 to
PVC pipe or other sturdy cylindrical object to cycle through the available preset blood pres-
simulate placement on a limb. Connect a piece sure simulations. Select a blood pressure of
of tubing to the pressure port on the BP Pump 2. 120/80 on the analyzer.
Connect a tee to this tubing and attach tubing Initiate a blood pressure measurement on the
and connectors. Connect the two legs of the NIBP monitor. The displayed pressure should be
tee between the hose and the cuff of the NIBP within 10 mmHg of the set pressure. For a set
monitor. blood pressure of 120/80, the systolic pressure
Place the NIBP monitor in service mode to should be between 110 mmHg and 130 mmHg
perform the leak test. Select ‘LEAK TEST’ on the and the diastolic pressure should be between
BP Pump 2. Press ‘SETUP’ to change the test 70 mmHg and 90 mmHg. Repeat the measure-
pressure set point. Use the number keys to enter ments for a blood pressure of 200/150 and a
a test pressure of 250 mmHg and then press blood pressure of 80/50.
‘ENT’. Press the soft key labeled ‘START’ on the

©University of Vermont, Rev. 2 – Confidential 107

 Auto interval time: Select a standard blood From the main menu, press the soft key
pressure on the BP Pump 2 of 120/80. Put the labeled ‘SIM’ to enter the simulation mode.
NIBP into automatic mode with an interval of Begin a manual simulation by pressing the
5 minutes. Use a stopwatch or a watch with soft key labeled ‘MAN’. Use the plus and minus
a second hand to measure the length of time keys to adjust the O2 level and heart rate. Set
between BP measurements. The measured time the heart rate to 60 bpm to match the heart
should be within 10 % of the set interval. For a rate from the MPS450. Adjust the O2 level on
set interval of 5 minutes, the measured interval the Index 2 to 96 %. Initiate a measurement on
should be between 4 minutes 30 seconds and the pulse oximeter. The displayed SpO2 value
5 minutes 30 seconds. should be within 3 digits of the set value. For
Stop/Cancel/Deflate: Initiate a blood pres- a simulated SpO2 of 96 %, the displayed value
sure measurement on the NIBP monitor. Allow should be between 93 % and 99 %.
the cuff to inflate. Stop the measurement on the SpO2 alarms: Set the high O2 alarm on the
monitor. The cuff should deflate in less than pulse oximeter to 98 %. Set the low O2 alarm
10 seconds. to 90 %. Set the Index 2 for a manual simula-
NIBP alarms: Select ‘STANDARD BP’ on tion with the SpO2 at 96 % and the heart rate
the BP Pump 2. Press the soft key labeled 80 bpm. Initiate a measurement on the pulse
‘OPTIONS’ on the BP Pump 2 and set the simu- oximeter. Adjust the SpO2 on the Index 2 to
lated blood pressure to 200/155. Set the high 100 %. The high O2 alarm on the pulse oxime-
alarm limits on the NIBP monitor lower than ter should activate. Bring the SpO2 back down
the simulated pressures. Set the high systolic to 96 % and clear the alarm. Adjust the SpO2 on
alarm to 195 mmHg, the high diastolic alarm to the Index 2 to 88 %. The low O2 alarm on the
150 mmHg, and the high mean pressure alarm pulse oximeter should activate. Bring the SpO2
to 160 mmHg. Initiate a blood pressure mea- back to 96 % and clear the alarm.
surement on the NIBP monitor. The high alarms Set the high heart rate alarm on the pulse
should activate. Clear the alarms on the moni- oximeter to 120 bpm and set the low heart rate
tor and return the alarm limits to their original alarm to 60 bpm. Adjust the heart rate on the
settings. Index 2 to 125 bpm. The high heart rate alarm
Select ‘STANDARD BP’ on the BP Pump 2 and should activate. Return the heart rate to 80 bpm
set the simulated blood pressure to 60/30. Set and clear the alarm. Adjust the heart rate on
the low alarm limits on the NIBP monitor higher the Index 2 to 55 bpm. The low heart rate alarm
than the simulated pressures. Set the low sys- should activate. Return the heart rate to 80 bpm
tolic alarm to 65 mmHg, the low diastolic alarm and clear the alarm. Return all alarm limits to
to 35 mmHg, and the low mean pressure alarm their original settings.
to 45 mmHg. Initiate a blood pressure mea- Invasive pressure accuracy: Set the blood
surement on the NIBP monitor. The low alarms pressure transducer sensitivity on the MPS450
should activate. according to manufacturer requirements. Press
O2 accuracy: Attach a finger probe to the the button labeled ‘0’ (‘SETUP’) to access the
pulse oximeter. Place the finger sensor on the set up menu. Press the soft key labeled ‘BP
finger simulator of the Index 2 simulator. From SENSE’ and then use the soft keys to toggle the
the main menu of the Index 2, press the soft key sensitivity between 5 µV/V/mmHg and
labeled ‘MORE’ for the second menu and then 40 µV/V/mmHg.
press the soft key labeled ‘MAKE’. Use the plus Press the key labeled ‘3’ (‘BP’) to enter the
and minus keys to scroll through the available blood pressure menu on the MPS450. Press
makes. Select the make of the pulse oximeter to the ‘BP1’ soft key and then press ‘ZERO’ to zero
be tested. When the correct make appears on the channel if necessary. Connect the invasive
the screen, press the ‘ESC’ key to return to the blood pressure cable to the BP1 port on the side
main menu. of the MPS450.

108 ©University of Vermont, Rev. 2 – Confidential

 Press the ‘DYNA’ soft key to start a dynamic alarm should activate. Return the temperature
pressure simulation. Select an arterial pressure on the MPS450 to 37 ºC and clear the alarm.
of 120/80. Press ‘RUN’ to begin the simulation. Adjust the temperature on the MPS450 to 24 ºC.
The pressure displayed on the monitor should The low temperature alarm should activate.
be within 5 % of the set pressure. For a simu- Return the temperature on the MPS450 to
lated pressure of 120/80, the displayed systolic 37 ºC and clear the alarm.
pressure should be between 114 mmHg and Carbon dioxide concentration accuracy:
126 mmHg and the diastolic pressure should be Connect the gas canister to the patient sample
between 76 mmHg and 84 mmHg. line of the monitor. Inject the gas into the
Invasive pressure alarms: Set the high- sample line. The displayed CO2 concentration
pressure alarm limits on the monitor lower should be within 0.4 vol% of the gas sample.
than 120/80. Set the high systolic alarm limit For a gas sample with 5.0 % CO2, the monitor
to 115 mmHg and the high diastolic alarm limit should display a CO2 concentration between
to 75 mmHg. The high alarms should activate. 4.6 % and 5.4 %.
Clear the alarms on the monitor and return the Carbon dioxide alarm: Set the high carbon
alarm limits to their original settings. dioxide alarm limit on the monitor to below the
Set the low-pressure alarm limits on the CO2 concentration of the test gas. Inject the gas
monitor higher than 120/80. Set the low into the patient sample tubing. The high CO2
systolic alarm limit to 125 mmHg and the low concentration alarm should activate. Return the
diastolic alarm limit to 85 mmHg. The low alarm limit to its original setting and clear the
alarm should activate. Clear the alarms on the alarm.
monitor and return the alarm limits to their Alarm function: Check that all alarms are
original settings. functional and that the volume is adequately
Temperature accuracy: Connect the temper- loud. Ensure that appropriate visual indicators
ature cable to the CO/TEMP port on the side are functioning.
of the MPS450. Press the key labeled ‘7’ Complete model-specific performance
(‘TEMP’) to start the temperature simulation. testing: Refer to the service manual for perfor-
Use the up and down keys to set the tempera- mance inspection tasks specific to the device.
ture to 37 ºC. The temperature displayed on the Complete the performance inspection per
monitor should be within 0.3 ºC of the set tem- manufacturer’s procedure.
perature. For a simulated temperature of 37 ºC, Return to service: Before returning to use,
the displayed temperature should be between return any settings that were adjusted to their
36.7 ºC and 37.3 ºC. original settings. Ensure the volume of the
Temperature alarms: Set the high tempera- audible alarms is loud enough to be heard in
ture alarm on the monitor to 38 ºC and set the normal operating conditions. Plug in the power
low temperature alarm to 34 ºC. Adjust the cord to ensure the battery remains charged.
temperature on the MPS450 to 40 ºC. The high

©University of Vermont, Rev. 2 – Confidential 109

PCA pump continuous infusion, as a demand dose only, or
PCA, patient controlled analgesic, pumps are as a continuous infusion with a demand dose. A
infusion pumps that deliver an analgesic drug demand dose is initiated by the patient pressing
on when requested by the patient. These a button. A predetermined amount of the drug is
pumps typically utilize tubing designed specifi- delivered rapidly as a bolus. PCA pumps have a
cally for use with PCA infusion pumps, which timing function that allows a ‘lockout interval’,
is then connected to an infusion catheter or to prevent an overdose of the analgesic.
other infusion device such as an implanted Recommended functional test frequency:
infusion port. PCA pumps can typically be pro- annual.
grammed to deliver in one of three ways, as a

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

110 ©University of Vermont, Rev. 2 – Confidential

 PCA pump procedure
Estimated time: 45 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
IDA 4 Plus Infusion Device Analyzer (or equivalent)
PCA trigger interface
Tubing set for PCA pump
Reservoir to connect to tubing set (bag, bottle, or syringe)
20 cc or larger syringe
3 way stopcock
Cable to connect PCA trigger interface to PCA pump
Tubing and connectors to connect infusion set to IDA4 Plus
Tubing and connectors to connect to IDA 4 Plus

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW

continued on page 112

©University of Vermont, Rev. 2 – Confidential 111

 PCA pump procedure
Estimated time: 45 minutes

continued from page 111

Test Result
Pass Fail N/A
Preventive maintenance
Clean flow detector
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Door lock
Pole clamp function
Load dose ± 10 %
Flow rate accuracy ± 10 %
Volume accuracy ± 10 %
PCA dose ± 10 %
Lock out interval ±5%
Dose limit
KVO rate ± 10 %
Occlusion detection pressure ± 1 psi
Alarm function
Complete model-specific performance testing

112 ©University of Vermont, Rev. 2 – Confidential

Physical condition Load dose: Fill the reservoir with a 1 % deter-
Check the physical condition of the device, as gent solution in de-ionized water. Prepare a 1 %
described in the General Equipment Procedure. stock solution of detergent such as Cole-Parmer
Micro-90 in volume using de-ionized water;
Electrical safety this may be stored in a closed vessel for up to
6 months. This solution should then be diluted
Perform electrical safety checks as described in 10:1 with de-ionized water for daily use. If the
Chapter 5, Electrical Safety. Check ground wire water used causes too much foaming, a 20:1
resistance and chassis leakage. dilution is recommended. Do not use tap water
or solutions intended for patient use, as these
Preventive maintenance may harm the transducers in the IDA 4 Plus.
Clean flow detector: Inspect the flow detector Connect the infusion tubing to the reser-
on the PCA pump. Clean any debris from the voir. Prime the set so that there is no air in
flow sensor. the tubing. With the tubing draining into a
Replace battery: The battery should be container or sink, open the flow control mecha-
replaced every 24 months. Replace if necessary. nism on the tubing set. Hold the reservoir high
Complete model-specific preventive main- enough above the tubing so that fluid flows
tenance: Refer to the monitor’s service manual through the tubing under the force of gravity.
for preventive maintenance tasks specific to the Allow fluid to flow through the tubing until no
device. Complete the preventive maintenance air bubbles can be seen in the tubing. Insert
per manufacturer’s procedure. the set into the pump. Connect the three-way
stopcock to the channel 1 port on the IDA 4
Performance inspection Plus. Connect the patient infusion tubing to one
Verify unit operates on battery: Check the port of the stopcock. Fill the syringe with the
ac power indicator is lit when the power cord detergent solution and connect the syringe to
is plugged into an outlet. Unplug the ac power the other port of the stopcock. Connect a piece
cord and perform the remainder of the func- of tubing to the drain port of channel 1 and run
tional test on battery power. The ac power the tubing into a container to catch the used
indicator should go out when the power cord solution.
is unplugged and the battery indicator should Connect the PCA trigger interface box to the
light. Be sure to plug the power cord in at the connector on the back of the IDA 4 Plus. Attach
conclusion of the test. a cable from channel 1 of the trigger output to
Door lock: Inspect the door assembly. the patient dose cable port on the PCA pump. If
Ensure the door swings smoothly and locks multiple PCA pumps are to be tested simultane-
with the key. ously, additional pumps can be connected to the
Pole clamp function: Check the physical other channels on the interface box.
condition of the pole clamp. The pole clamp From the status screen on the IDA 4 Plus,
should be securely fastened to the pump. The select ‘UTIL’ to enter the utilities menu and then
clamp mechanism should move freely. The pole select ‘TEST PARAMATERS’ from the utilities
clamp should secure the pump to the IV pole. menu. Use the arrow keys to adjust the PCA Pre
Ensure the pole clamp cannot be released when Trig Time to 60 seconds. This is the time prior
the pump is locked. to the expiry of the lock out interval that the
IDA 4 Plus will begin attempting to trigger the
PCA dose.

©University of Vermont, Rev. 2 – Confidential 113

 Return to the main set-up screen and use the Volume accuracy: Continue to run the PCA
arrow keys to select ‘SETUP’ under channel 1. pump as described above. The IDA 4 Plus will
Use the arrow keys on the set-up menu to select display the total volume delivered. Allow the
‘PCA’. Use the arrow keys to enter the basal pump to deliver at least 10 mL and then com-
flow rate, total volume, bolus volume, lockout pare the measured volume displayed on the
time, and loading dose to be tested. Enter a analyzer to the volume displayed on the pump.
basal flow rate of 15 mL/hr. Enter a total volume The measured volume should be within 10 %
of 20 mL. Enter a bolus volume of 1 mL. Enter of the pump volume. For a volume of 10 mL, the
a lockout time of 5 minutes 0 seconds. Enter a measured volume should be between 9 mL and
loading dose of 1 mL. After the test information 11 mL.
is entered, the PCA test screen will appear. Use PCA dose: Continue to run the PCA pump as
the arrow keys to highlight ‘PRIME’. Close the described above. The IDA 4 Plus will display
stopcock port connected to the infusion tubing, the delivered bolus volume. Allow the pump to
leaving the ports to the syringe and the IDA deliver a bolus and then compare the measured
4 Plus open. Inject the solution in the syringe volume displayed on the analyzer to the set
into the IDA 4 Plus until ‘START’ appears on the volume. Verify that the actual bolus volume is
screen. Select ‘AutoSTART’. The IDA 4 Plus will within 10 % of the set volume. For a dose of
start the flow test when it detects flow from the 1 mL, the measure volume should be between
pump. Close the port to the syringe, leaving the 0.9 mL and 1.1 mL.
ports to the tubing and the IDA 4 Plus open. Lock out interval: Continue to run the PCA
Set up the PCA pump as entered on the IDA 4 pump as described above. The IDA 4 Plus will
Plus. Set the continuous flow rate to 15 mL/hr, attempt to trigger a PCA dose 60 seconds before
the bolus volume to 1 mL, the lockout time to the lock out time expires. Allow the PCA pump
5 minutes, and the loading dose to 1 mL. If to deliver at least 2 doses. The interval time will
the PCA pump has a dose limit, set the limit to be displayed on the IDA 4 Plus. The measured
2 mL. interval time should be within 5 % of the set
Start the pump. The loading dose will appear lock out interval. For a lock out interval of
on the PCA test screen. Verify that the actual 5 minutes, the measured interval time should
bolus volume is within 10 % of the set volume. be between 4 minutes 45 seconds and 5 min-
For a dose of 1 mL, the measure volume should utes 15 seconds.
be between 0.9 mL and 1.1 mL. Dose limit: Continue to run the PCA pump
The IDA 4 Plus is equipped with four chan- as described above and allow it to deliver
nels to analyze infusion devices. Four pumps 20 mL. When the pump reaches the dose limit,
can be run simultaneously. the dose limit alarm should activate. The pump
Flow rate accuracy: Continue to run the PCA should no longer deliver the continuous rate,
pump as described above. The IDA 4 Plus will nor allow any boluses. The pump may continue
display the basal flow rate. Allow the pump to to deliver a KVO rate.
deliver at least 10 mL and then compare the KVO rate: When the PCA pump reaches its
measured flow rate to the set rate. The mea- dose limit, it will go into a KVO rate to supply
sured flow rate should be within 10 % of the set a very low flow rate in order to keep the vein
rate. For a flow rate of 15 mL/hr, the measured open if another infusion needs to be given.
flow rate should be between 13.5 mL/hr and Measure the KVO rate using the ‘FLOW’ function
16.5 mL/hr. on the IDA 4 Plus.

114 ©University of Vermont, Rev. 2 – Confidential

 Allow the pump to reach its dose limit, but do The tubing can be occluded either by closing
not stop the pump. Instead, silence the alarm a clamp attached to the tubing or by pinching
and let the pump run. Enter the ‘FLOW’ screen the tubing with a set of hemostats or pliers. The
on the IDA 4 Plus to measure the KVO rate. It pump should alarm upstream occlusion.
may take several minutes for the analyzer to Clear the alarm and restart the pump. Occlude
be able to measure the low rate. The measured the tubing after the pump. The pump should
rate should be within 10 % of the infusion alarm downstream occlusion. Clear the alarm.
pump’s KVO rate. Check the service manual for If the pump is equipped with an air detector,
the exact rate. For a KVO rate of 1 mL/hr, the introduce air into the tubing. This can be done
measured rate should be between 0.9 mL/hr by turning the reservoir upside down until a
and 1.1 mL/hr. bubble of air is pulled through the tubing. Turn
Occlusion detection pressure: From the the reservoir right side up. When the air bubble
channel set up menu on the IDA 4 Plus, select gets to the pump, the pump should alarm air in
‘OCCLUSION’. Prime the IDA 4 Plus with the line. Clear the alarm. Remove the tubing from
syringe if necessary. Set the flow rate on the the pump and prime the set so that there is no
PCA pump to 15 mL/hr and start the pump. air in the tubing. Reinsert the tubing set into
Select ‘START’ on the IDA 4 Plus. Select ‘END’ the pump and restart the pump.
on the IDA 4 Plus when the pump alarms occlu- Simulate an empty container situation either
sion. Note the pressure at which the pump by turning the reservoir upside down so that
alarms. Compare the measured pressure to the no fluid can get to the tubing, or by removing
occlusion pressure of the pump. The occlusion the tubing from the reservoir. The pump should
pressure will be specific to the model. Check alarm when no fluid flow is detected.
the service manual for the specific pressure. Complete model-specific performance
The measured occlusion pressure should be testing: Refer to the service manual for perfor-
within 1 psi of the pump’s occlusion pressure. mance inspection tasks specific to the device.
For an occlusion pressure of 20 psi, the mea- Complete the performance inspection per
sured pressure should be between 19 psi and manufacturer’s procedure.
21 psi. Return to service: Before returning to use,
Alarm function: Check that all alarms are return any settings that were adjusted to their
functional and that the volume is adequately original settings. Ensure the volume of the
loud. Ensure that appropriate visual indicators audible alarms is loud enough to be heard in
are functioning. normal operating conditions. Plug in the power
Set the continuous rate on the pump to cord to ensure the battery remains charged.
15 mL/hr. and start the pump. Occlude the
tubing between the reservoir and the pump.

©University of Vermont, Rev. 2 – Confidential 115

Phototherapy unit to break down the bilirubin. A photo oxidation
Phototherapy units irradiate patients with light process causes the converts water-insoluble
to produce beneficial bioeffects. Most commonly, bilirubin to water-soluble compounds that can
these devices are used to treat hyperbiliru- be excreted. Most commonly, phototherapy units
binemia, jaundice, in newborns. Phototherapy are seen as overhead units that apply the light
units for this purpose are sometimes referred to radiation from a lamp. Phototherapy units are
as bili lights. Blue light, typically with a wave- also available as pad or blanket with a separate
length between 420 nm and 480 nm, is used light source connected by a fiberoptic cable.
Recommended functional test frequency:
annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

116 ©University of Vermont, Rev. 2 – Confidential

 Phototherapy unit procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
DALE40 Phototherapy Radiometer (or equivalent)
Stopwatch or watch with a second hand

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Inspect bulbs
Complete model-specific preventive maintenance
Performance testing
Timer accuracy ± 0.5 %
Output accuracy ≥ 4.5 µW/cm2/nm
(≥ 198 µW/cm2 @ 44 nm bandwidth)
≤ 40 µW/cm2/nm
(≤ 1760 µW/cm2 @ 44 nm bandwidth)
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 117

Physical condition set time of 120 seconds, the actual measured
Check the physical condition of the device, as time should be between 114 seconds and
described in the General Equipment Procedure. 126 seconds. Verify that treatment stops when
the timer stops.
Electrical safety Output accuracy: Initiate a phototherapy
treatment. Place the photodetector probe facing
Perform electrical safety checks as described in the light about 18 inches (45.7cm) from the light
Chapter 5, Electrical Safety. Check ground wire source. The irradiance will be displayed on the
resistance and chassis leakage. Dale40. The measured irradiance should be
between 198 µW/cm2 and 1760 µW/cm2. Refer
Preventive maintenance to the phototherapy unit’s service manual for
Inspect bulbs: Inspect the phototherapy unit the unit’s output range.
for broken or burned out bulbs. Replace as Alarm function: Check that all alarms are
necessary. functional and that the volume is adequately
Complete model-specific preventive main- loud. Ensure that appropriate visual indicators
tenance: Refer to the monitor’s service manual are functioning.
for preventive maintenance tasks specific to the Complete model-specific performance
device. Complete the preventive maintenance testing: Refer to the service manual for perfor-
per manufacturer’s procedure. mance inspection tasks specific to the device.
Complete the performance inspection per
Performance inspection manufacturer’s procedure.
Timer accuracy: Set the timer for 2 minutes. Return to service: Before returning to use,
Initiate treatment and begin timing with the return any settings that were adjusted to their
stopwatch. Initiate phototherapy treatment and original settings. Ensure the volume of the
begin timing with a stopwatch or a watch with audible alarms is loud enough to be heard in
a second hand. The treatment timer should normal operating conditions.
sound within 5 % of the measured time. For a

118 ©University of Vermont, Rev. 2 – Confidential

 Pneumatic tourniquet and arteries and preventing blow flow past the
Tourniquets are used to prevent blow flow to cuff. The pneumatic tourniquet measures and
a limb during surgery. A pneumatic tourniquet displays the cuff pressure and inflation time.
consists of an inflatable cuff, an air pump, The cuff itself is typically dual chambered,
pressure sensors, and a processor to control allowing for alternation of the pressure site.
cuff pressure. The cuff is placed on the limb Recommended functional test frequency:
proximal to the operative site. The cuff is then semiannual.
inflated to a preset pressure, occluding vessels

Sample risk assessment

Criteria - choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 14
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 119

 Pneumatic tourniquet procedure
Estimated time: 35 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent) Squeeze bulb with bleed valve
DPM 4 Pressure Meter (or equivalent) Tubing and connectors to connect
Stopwatch or watch with a second hand to DPM 4
PVC pipe to attach tourniquet cuff to

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Check condition of tubing, cuffs, and hoses
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Verify function of control valve
Controller stability ± 10 mmHg after 15 min
Cuff pressure accuracy ±5%
Timer accuracy ± 2 min after 15 min
Maximum cuff pressure ≤ 550 mmHg or
manufacturer’s specification
Complete model-specific performance testing

120 ©University of Vermont, Rev. 2 – Confidential

Physical condition Verify function of control valve: Connect
Check the physical condition of the device, as hoses and cuffs to the pneumatic tourniquet.
described in the General Equipment Procedure. Place the cuffs around a piece of PVC pipe
or other sturdy cylindrical object to simulate
Electrical safety placement on a limb. Inflate the proximal cuff.
Ensure the tourniquet is able to hold pressure.
Perform electrical safety checks as described in Inflate the distal cuff. Again, Ensure the tour-
Chapter 5, Electrical Safety. Check ground wire niquet is able to hold pressure and then deflate
resistance and chassis leakage. the cuff. Inflate both cuffs together. Hold the
pressure for a short time and then deflate. If the
Preventive maintenance tourniquet has multiple channels, repeat the
Check condition of tubing, cuffs, and hoses: test for each channel.
Inspect hoses and cuffs for signs of wear. Look Controller stability: Attach a 3-way connec-
for holes, cracks, and dry rot. Ensure that all tor to the pressure port on the DPM 4. Attach a
connections are secure. squeeze ball to one leg of the connector. Ensure
Replace battery: The battery should be the bleed valve on the squeeze ball is closed.
replaced every 24 months. Replace if necessary. Attach another 3-way connector to the other
Complete model-specific preventive main- leg. Connect the remaining two legs between
tenance: Refer to the monitor’s service manual the hose and the cuff of the tourniquet.
for preventive maintenance tasks specific to the Set the pressure on the pneumatic tourniquet
device. Complete the preventive maintenance to 400mmHg and inflate the cuff. Allow the
per manufacturer’s procedure. pressure to stabilize for 15 minutes. After
15 minutes, the pressure should be between
Performance inspection 390 mmHg and 410 mmHg.
Verify unit operates on battery: Check that Cuff pressure accuracy: Set the pressure on
the ac power indicator is lit when the power the pneumatic tourniquet to 200 mmHg and
cord is plugged into an outlet. Unplug the ac inflate the cuff. Observe the pressure for at least
power cord and perform the remainder of the two minutes to Ensure the pressure remains
functional test on battery power. The ac power stable. The displayed pressure should be within
indicator should go out when the power cord 5 % of the measured pressure. For a displayed
is unplugged and the battery indicator should pressure of 200 mmHg, the measured pressure
light. Be sure to plug the power cord in at the should be between 190 mmHg and 210 mmHg.
conclusion of the test. Set the cuff pressure to 450 mmHg and repeat
the measurement. At this setting, the measured
pressure should be between 427.5 mmHg and
472.5 mmHg.

©University of Vermont, Rev. 2 – Confidential 121

 Timer accuracy: Inflate the cuff on the Alarm function: Check that all alarms are
pneumatic tourniquet. Use a stopwatch or a functional and that the volume is adequately
watch with a second hand to measure the loud. Ensure that appropriate visual indicators
elapsed time. Allow the cuff to remain inflated are functioning.
for 15 minutes. The elapsed time displayed on Inflate the tourniquet cuff. Slowly open the
the tourniquet should be between 13 and bleed valve on the squeeze ball to simulate a
17 minutes. leak. The tourniquet leak alarm should activate.
Maximum cuff pressure: Set the pressure Complete model-specific performance
on the pneumatic tourniquet to its maximum testing: Refer to the service manual for perfor-
setting. Inflate the cuff and allow the pres- mance inspection tasks specific to the device.
sure to stabilize. Use the squeeze ball to slowly Complete the performance inspection per
increase the pressure in the cuff until the manufacturer’s procedure.
pressure relief valve vents the pressure in the Return to service: Before returning to use,
cuff. Note the pressure at which the relief valve return any settings that were adjusted to their
is triggered. The over pressure limit should be original settings. Ensure the volume of the
less than 550 mmHg. Check the manufacturer’s audible alarms is loud enough to be heard in
service manual for the exact value. normal operating conditions. Plug in the power
cord to ensure the battery remains charged.

122 ©University of Vermont, Rev. 2 – Confidential

 Pulse oximeter hemoglobin (HHb) absorb red and infrared light
A pulse oximeter non-invasively measures the differently. The percent saturation of hemo-
oxygen saturation of a patient’s blood. A pulse globin in arterial blood can be calculated by
oximeter consists of a red and an infrared light measuring light absorption changes caused by
source, photo detectors, and probe to transmit arterial blood flow pulsations.
light through a translucent, pulsating arterial Recommended functional test frequency:
bed, typically a fingertip or earlobe. Oxygen- annual.
ated hemoglobin (O2Hb) and deoxygenated

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 123

 Pulse oximeter procedure
Estimated time: 20 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
Index 2 SpO2 Analyzer (or equivalent)

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean recorder paper compartment, rollers and paper guides
Lubricate motor and paper drive mechanism
Verify proper time and date, correct if necessary
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Heart rate accuracy ±5%
SpO2 accuracy ±3%
Recorder operation
Alarm function
Complete model-specific performance testing

124 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Verify proper time and date. Correct if nec-
Check the physical condition of the device, as essary: Verify that the time and date displayed
described in the General Equipment Procedure. on the monitor is correct. If the time and date is
not displayed on the monitor, print a strip from
Electrical safety the recorder. The time and date should appear
on the printed strip. Correct the time and date
Perform electrical safety checks as described in as necessary.
Chapter 5, Electrical Safety. Check ground wire Replace battery: The battery should be
resistance and chassis leakage. replaced every 24 months. Replace if necessary.
Complete model-specific preventive main-
Preventive maintenance tenance: Refer to the monitor’s service manual
Clean recorder paper compartment, roll- for preventive maintenance tasks specific to the
ers, and paper guides: Inspect the rollers and device. Complete the preventive maintenance
paper guides and remove any debris. Check for per manufacturer’s procedure.
bits of torn paper caught in the rollers.
Lubricate motor and paper drive mecha- Performance inspection
nism: Follow the manufacturer’s instructions Verify unit operates on battery: Check that
in the service manual for lubricating the motor the ac power indicator is lit when the power
and paper drive mechanism. Not all motors will cord is plugged into an outlet. Unplug the ac
need to be lubricated. power cord and perform the remainder of the
functional test on battery power. The ac power
indicator should go out when the power cord
is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
conclusion of the test.
Heart rate accuracy: Attach a finger probe
to the pulse oximeter. Place the finger sensor
on the finger simulator of the Index 2 simulator.
From the main menu of the Index 2, press the
soft key labeled ‘MORE’ for the second menu
and then press the soft key labeled ‘MAKE’. Use
the plus and minus keys to scroll through the
available makes. Select the make of the pulse
oximeter to be tested. When the correct make
appears on the screen, press the ‘ESC’ key to
return to the main menu.

Pulse oximeter connected to Index 2 SpO2 simulator.

©University of Vermont, Rev. 2 – Confidential 125

 From the main menu, press the soft key at 96 % and the heart rate 80 bpm. Initiate a
labeled ‘SIM’ to enter the simulation mode. measurement on the pulse oximeter. Adjust
Begin a manual simulation by pressing the soft the SpO2 on the Index 2 to 100 %. The high O2
key labeled ‘MAN’. Use the plus and minus keys alarm on the pulse oximeter should activate.
to adjust the O2 level and heart rate. Set the Bring the SpO2 back down to 96 % and clear
heart rate to 80 bpm. Turn on the pulse oxime- the alarm. Adjust the SpO2 on the Index 2 to
ter and initiate a measurement. The displayed 88 %. The low O2 alarm on the pulse oximeter
heart rate should be within 5 % of the set heart should activate. Bring the SpO2 back to 96 %
rate. For a simulated heart rate of 80 bpm, the and clear the alarm.
displayed heart rate should be between 76 bpm Set the high heart rate alarm on the pulse
and 84 bpm. oximeter to 120 bpm and set the low heart rate
O2 accuracy: Adjust the O2 level on the Index alarm to 60 bpm. Adjust the heart rate on the
2 to 96 %. Initiate a measurement on the pulse Index 2 to 125 bpm. The high heart rate alarm
oximeter. The displayed SpO2 value should be should activate. Return the heart rate to 80 bpm
within 3 % of the set value. For a simulated and clear the alarm. Adjust the heart rate on
SpO2 of 96 %, the displayed value should be the Index 2 to 55 bpm. The low heart rate alarm
between 93 % and 99 %. should activate. Return the heart rate to 80 bpm
Recorder operation: After taking some and clear the alarm. Return all alarm limits to
O2 measurements, print the results with the their original settings.
recorder. Ensure the recorder prints clearly Complete model-specific performance
and legibly. If the date and time is present on testing: Refer to the service manual for perfor-
the recorded strip, Ensure the date and time is mance inspection tasks specific to the device.
accurate. Complete the performance inspection per
Alarm function: Check that all alarms are manufacturer’s procedure.
functional and that the volume is adequately Return to service: Before returning to use,
loud. Ensure that appropriate visual indicators return any settings that were adjusted to their
are functioning. original settings. Ensure the volume of the
Set the high O2 alarm on the pulse oximeter audible alarms is loud enough to be heard in
to 98 %. Set the low O2 alarm to 90 %. Set the normal operating conditions. Plug in the power
Index 2 for a manual simulation with the SpO2 cord to ensure the battery remains charged.

126 ©University of Vermont, Rev. 2 – Confidential

 Radiant warmer probe. Typically, the radiant warmer is set
Radiant warmers provide thermal stability to to a temperature and a temperature probe is
infants. They are used to provide thermal sup- attached to the infant’s skin. The heater will
port to newborns and critically ill infants and turn on while the infant’s skin temperature is
also for infants undergoing long procedures in below the set temperature. When the skin tem-
a cool environment. Unlike incubators, radi- perature reaches the set temperature, the heater
ant warmers are not enclosed, allowing direct turns off.
access to the infant. These devices typically Recommended functional test frequency:
consist of an overhead heater and a temperature semiannual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 14
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 127

 Radiant warmer procedure
Estimated time: 35 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
INCU incubator analyzer (or equivalent)

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean vents and filters
Replace battery every 24 months
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Fan operation
Temperature accuracy ± 0.3 ºC
Temperature alarms
Alarm function
Complete model-specific performance testing

128 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Performance inspection
Check the physical condition of the device, as Verify unit operates on battery: Check that
described in the General Equipment Procedure. the ac power indicator is lit when the power
cord is plugged into an outlet. Unplug the ac
Electrical safety power cord and perform the remainder of the
Perform electrical safety checks as described in functional test on battery power. The ac power
Chapter 5, Electrical Safety. Check ground wire indicator should go out when the power cord
resistance and chassis leakage. is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
Preventive maintenance conclusion of the test.
Fan operation: Inspect the fan blades for
Clean vents and filters: Inspect vents and air
damage. Look for chips, warping, melting, and
filters. Clean or replace filters as necessary.
missing blades. Ensure there is adequate clear-
Ensure that filters are installed properly.
ance around the fan assembly. Look for signs of
Replace battery: The battery should be
rubbing around the fan housing. Lubricate the
replaced every 24 months. Replace if necessary.
fan motor per the manufacturer’s specification.
Complete model-specific preventive main-
Follow the manufacturer’s instructions in the
tenance: Refer to the monitor’s service manual
service manual for lubricating the pump motor.
for preventive maintenance tasks specific to the
Not all motors will need to be lubricated.
device. Complete the preventive maintenance
per manufacturer’s procedure.

INCU placed in radiant warmer. INCU with radiant warmer adapter.

©University of Vermont, Rev. 2 – Confidential 129

 Temperature accuracy: Set the warmer tem- back in the warmer and allow the tempera-
perature to 34 ºC. Place the INCU in the center ture to stabilize. Hold the sensor close to the
of the incubator. Place the T1 and T3 tempera- heater. Verify that the high temperature alarm
ture probes so that they are placed vertically activates.
in opposite corners. Clip the T2 probe to the Alarm function: Check that all alarms are
underside of the radiant baby adapter. Place functional and that the volume is adequately
the radiant baby adapter on top of the INCU and loud. Ensure that appropriate visual indicators
align it with the heater in the warmer. are functioning.
Place the skin temperature probe from the Unplug the temperature probe from the incu-
warmer in close proximity to the T2 sensor. bator. The disconnected probe alarm should
Allow the temperature to stabilize. Press the activate. If the incubator is equipped with
‘SELECT’ button on the INCU to cycle through alarms for an open or short circuited tempera-
the readings. Place the skin temperature probe ture probe, use open and short circuited probe
in close proximity to the T2 sensor on the INCU. plugs to test these alarms. Disconnect the skin
Allow the incubator temperature to stabilize. temperature probe and connect the probe plugs.
The measured temperature on the T2 sensor The appropriate alarms should activate.
should be within 0.3 ºC of the displayed skin Unplug the incubator to simulate a power fail-
temperature on the incubator. For a displayed ure. The power failure alarm should activate.
skin temperature of 34 ºC, the measured Complete model-specific performance
temperature should be between 33.7 ºC and testing: Refer to the service manual for perfor-
34.3 ºC. Repeat the temperature measurements mance inspection tasks specific to the device.
at 36 ºC and 38 ºC. Complete the performance inspection per
Temperature alarms: Adjust the temperature manufacturer’s procedure.
set point on the warmer to its maximum set- Return to service: Before returning to use,
ting. Place the sensor in the warmer and allow return any settings that were adjusted to their
the temperature to stabilize. Remove the skin original settings. Ensure the volume of the
temperature sensor from the warmer and allow audible alarms is loud enough to be heard in
it to cool. Verify that the low temperature alarm normal operating conditions. Plug in the power
activates. Place the skin temperature sensor cord to ensure the battery remains charged.

130 ©University of Vermont, Rev. 2 – Confidential

 Sphygmomanometer The cuff is then deflated slowly while a clini-
A sphygmomanometer is a device for measur- cian uses a stethoscope to listen for Korotkoff
ing blood pressure. It consists of an inflatable sounds, the sound of blood flow through the
cuff, an inflation bulb with a one way valve, artery, at the brachial pulse. The pressure at
and a pressure meter. The pressure meter may which the first sound is heard as the cuff is
be either a mercury manometer or an aneroid deflating is the systolic pressure. The pressure
gauge, although many healthcare institutions at which sounds are no longer heard is the
no longer allow the use of mercury. Typically, diastolic pressure.
the cuff is placed around the patient’s arm Recommended functional test frequency:
and then inflated until the artery is occluded. annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 10
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 131

 Sphygmomanometer procedure
Estimated time: 5 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: DPM 4 Pressure Meter (or equivalent)
Stopwatch or watch with a second hand
Tubing and connectors to connect to DPM 4
PVC pipe to attach cuff to

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Preventive maintenance
Check condition of tubing, cuffs, and hoses
Complete model-specific preventive maintenance
Performance testing
Gauge zero ± 1 mmHg
Leak test ≤ 15 mmHg/min
Pressure accuracy ± 3 mmHg
Complete model-specific performance testing

132 ©University of Vermont, Rev. 2 – Confidential

Physical condition Connect a tee to this tubing and attach tubing
Check the physical condition of the device, as and connectors. Connect the two legs of the
described in the General Equipment Procedure. tee to between the hose and the cuff of the
sphygmomanometer. Close the bleed valve and
Electrical safety use the cuff’s squeeze ball to inflate the cuff to
the maximum pressure indicated on the gauge.
Perform electrical safety checks as described in After 1 minute, read the pressure indicated
Chapter 5, Electrical Safety. Check ground wire on the gauge. The pressure should not have
resistance and chassis leakage. dropped more than 15mmHg in 1 minute.
Pressure accuracy: Inflate the cuff to until
Preventive maintenance 200 mmHg is read on the DPM 4. Read the
Check condition of tubing, cuffs, and hoses: pressure on the sphygmomanometer gauge.
Inspect hoses and cuffs for signs of wear. Look The pressure on the gauge should be within
for holes, cracks, and dry rot. Ensure that all 3 mmHg of the true pressure measured on
connections are secure. the DPM 4. For a pressure of 200 mmHg, the
Complete model-specific preventive main- gauge should read between 197 mmHg and
tenance: Refer to the monitor’s service manual 203 Hg. Repeat the pressure measurement for
for preventive maintenance tasks specific to the 120 mmHg and 60 mmHg.
device. Complete the preventive maintenance Complete model-specific performance
per manufacturer’s procedure. testing: Refer to the service manual for perfor-
mance inspection tasks specific to the device.
Performance inspection Complete the performance inspection per
Gauge zero: With no pressure in the cuff, manufacturer’s procedure.
read the pressure on the gauge of the sphyg- Return to service: Before returning to use,
momanometer. The gauge should read between return any settings that were adjusted to their
-1 mmHg and 1 mmHg. Discard aneroid gauges original settings. Ensure the volume of the
that cannot be reset to zero. audible alarms is loud enough to be heard in
Leak test: Place the cuff around a piece of normal operating conditions. Plug in the power
PVC pipe or other sturdy cylindrical object to cord to ensure the battery remains charged.
simulate placement on a limb. Connect a piece
of tubing to the pressure port on the DPM 4.

©University of Vermont, Rev. 2 – Confidential 133

Therapeutic stimulator controls, and a timer. A controlled electrical
Therapeutic stimulators cause controlled mus- current is delivered to the muscles through
cular contractions by applying electrical stimuli electrodes applied to the patient’s skin. Thera-
to nerves that control muscle activity. They are peutic stimulators are often used in conjunction
typically used during physical therapy for pain with therapeutic ultrasound.
management and to reduce swelling. These Recommended functional test frequency:
devices consist of a pulse generator, intensity annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

134 ©University of Vermont, Rev. 2 – Confidential

 Therapeutic stimulator procedure
Estimated time: 25 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
Oscilloscope such as Fluke 199XRAY
Stopwatch or watch with a second hand

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Inspect leads and electrodes
Complete model-specific preventive maintenance
Performance testing
Output accuracy ± 10 %
Timer accuracy ± 10 sec
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 135

Physical condition the stimulator and adjust the output to 20 mA.
Check the physical condition of the device, as Read the current measured on the scope. The
described in the General Equipment Procedure. measured current should be within 10 % of the
set current. With a set current of 10 mA, the
Electrical safety measured current should be between 9 mA and
11 mA. Repeat the measurement for 25 mA,
Perform electrical safety checks as described in 50 mA, and 100 mA.
Chapter 5, Electrical Safety. Check ground wire Timer accuracy: Set the treatment timer on
resistance and chassis leakage. the stimulator for 1 minute. Start the stimulator
and begin timing with a stopwatch or a watch
Preventive maintenance with a second hand. The treatment timer should
Inspect leads and electrodes: Inspect leads sound between 50 seconds and 70 seconds.
and electrodes for signs of wear such as frayed Verify that the there is no output after the
wires or broken strain reliefs. Inspect electrodes timer stops.
for corrosion or a build up of conductive gel. Alarm function: Check that all alarms are
Clean if necessary. functional and that the volume is adequately
Complete model-specific preventive main- loud. Ensure that appropriate visual indicators
tenance: Refer to the monitor’s service manual are functioning.
for preventive maintenance tasks specific to the Remove one of the electrode cables from the
device. Complete the preventive maintenance scope probe, being careful not to touch the
per manufacturer’s procedure. exposed electrode. Verify that the electrode
disconnection alarm activates.
Performance inspection Complete model-specific performance
Output accuracy: Connect the scope probe testing: Refer to the service manual for perfor-
to channel A of the oscilloscope. Press the mance inspection tasks specific to the device.
‘SCOPE’ button on the 199XRAY to enter oscil- Complete the performance inspection per
loscope mode. Press the ‘A’ button on the scope manufacturer’s procedure.
to access the settings for channel A. Press the Return to service: Before returning to use,
F3 (‘PROBE A’) and set the probe type to cur- return any settings that were adjusted to their
rent. Connect the stimulator electrode cable to original settings. Ensure the volume of the
the scope probe. Set the simulator to a Rus- audible alarms is loud enough to be heard in
sian waveform with a continuous cycle. Start normal operating conditions.

136 ©University of Vermont, Rev. 2 – Confidential

 Therapeutic ultrasound effect from the vibration of the tissue, causing
Therapeutic ultrasounds deliver ultrasonic microscopic air bubbles to form. The air bub-
waves that penetrate tissues and cause thermal bles transmit the vibrations and stimulate cell
and non-thermal effects and are typically used membranes. Therapeutic ultrasounds consist of
to speed healing in soft tissue injuries. Energy a radio frequency generator, usually 1 MHz to
from the sound waves is absorbed and causes 3 MHz, an intensity controller, and an applicator
heating in the tissue, resulting in an increase in containing a piezoelectric transducer.
blood flow, which speeds healing and reduces Recommended functional test frequency:
swelling. Sound waves also cause a cavitational annual.

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4 4
Device is used for a life support 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3 3
Device failure could result in severe injury to, or death of, patient or user 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3 3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1 1
A significant history of incidents exists 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1 1
There are requirements for testing independent of a numerical rating system 2
Total Score: 12
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 1

©University of Vermont, Rev. 2 – Confidential 137

 Therapeutic ultrasound procedure
Estimated time: 25 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
UW5 Ultrasound wattmeter (or equivalent)
Stopwatch or watch with a second hand

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Inspect sound head
Complete model-specific preventive maintenance
Performance testing
Verify unit operates on battery
Output accuracy ± 20 %
Duty cycle
Timer accuracy ± 10 sec
Alarm function
Complete model-specific performance testing

138 ©University of Vermont, Rev. 2 – Confidential

 Physical condition Performance inspection
Check the physical condition of the device, as Output accuracy: Ensure the UW5 is level
described in the General Equipment Procedure. before testing. If necessary, level the UW5 using
the adjustable leveling jacks on the underside
Electrical safety of the unit. Place the transducer cone on the
Perform electrical safety checks as described in mounting pin in the transducer well. Fill the
Chapter 5, Electrical Safety. Check ground wire transducer well with 850 ml ± 50 ml de-ionized
resistance and chassis leakage. and degassed water. The water should be at
room temperature. Turn on the UW5 and allow
Preventive maintenance at least 5 minutes for it to stabilize at room
temperature. Press the ‘ZERO’ button to zero the
Inspect sound head: Inspect the sound head
wattmeter.
for signs of wear such as frayed wires or broken
Place the appropriately sized centering ring
strain reliefs. Look for corrosion or a build up of
over the transducer well. Place the sound head
conductive gel. Clean if necessary.
in the transducer well so that it is centered and
Complete model-specific preventive main-
vertical. The sound head should be completely
tenance: Refer to the monitor’s service manual
coupled with water.
for preventive maintenance tasks specific to the
Start the ultrasound with a continuous duty
device. Complete the preventive maintenance
cycle and bring the output to the maximum
per manufacturer’s procedure.
setting. Measure the ultrasound output on the
UW5. The measured output should be within
20 % of the set output. For a set output of
20 W, the measured output should be between
16 W and 24 W. Repeat this measurement for
all frequencies.
Duty cycle: Start an ultrasound treatment at
10 W and a continuous (100 %) duty cycle.
The output on the UW5 should be approximately
10 W. Adjust the duty cycle to 50 %. The ultra-
sound output on the wattmeter should fall to
50 % of the output setting, or 5 W. Cycle
through all of the available duty cycles and
verify the output.
Timer accuracy: Set the treatment timer on
the stimulator for 1 minute. Start the stimulator
and begin timing with a stopwatch or a watch
with a second hand. The treatment timer should
sound between 50 seconds and 70 seconds.
Verify that the there is no output after the
timer stops.

Measuring ultrasound power output with the UW5.

©University of Vermont, Rev. 2 – Confidential 139

 Alarm function: Check that all alarms are completely drain the well. Remove the drain
functional and that the volume is adequately tube from its storage clip. Holding the tube end
loud. Ensure that appropriate visual indicators over a container, pinch the tube just in front of
are functioning. the stopper with one hand while pulling the
Disconnect the sound head cable from the stopper out with the other. Remove the stop-
ultrasound. Verify that the sound head discon- per and allow the water to drain completely.
nection alarm activates. The UW5 should be fully drained before being
Complete model-specific performance stored. This will prevent bacterial growth and
testing: Refer to the service manual for perfor- other potential water related damage.
mance inspection tasks specific to the device. Return to service: Before returning to use,
Complete the performance inspection per return any settings that were adjusted to their
manufacturer’s procedure. original settings. Ensure the volume of the
Remove the water from the transducer well of audible alarms is loud enough to be heard in
the UW5 when the measurements are complete. normal operating conditions.
Using the drain tube located in the bottom front,

140 ©University of Vermont, Rev. 2 – Confidential

 Ventilator a control system, monitors, alarms, and a source
Ventilators mechanically move air into and of gas, either an internal compressor or external
out of the lungs, to provide respiration for a connections for compressed gas cylinders or the
patient who is physically unable to breathe, hospital gas wall outlets.
or is breathing insufficiently. Most ventilators Recommended functional test frequency:
use positive pressure to gas to the lungs. These semiannual.
devices typically consist of a breathing circuit,

Sample risk assessment

Criteria – choose 1 rating from each category Weight Score
Clinical function
No patient contact 1
Device may make contact with patient but function is non-critical 2
Device is used for patient diagnosis, or direct monitoring 3
Device is used to deliver direct treatment to the patient 4
Device is used for a life support 5 5
Physical risk
Device poses no appreciable risk due to failure 1
Device failure will result in low risk 2
Device failure will result in inappropriate therapy, misdiagnosis, or loss of monitoring 3
Device failure could result in severe injury to, or death of, patient or user 4 4
Problem avoidance probability
Maintenance or inspection would not impact reliability of the device 1
Common device failure modes are unpredictable or not very predictable 2
While common device failure modes are not very predictable, device history indicates that TSP
3
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance 4 4
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5
Incident history
No significant history 1
A significant history of incidents exists 2 2
Manufacturers/regulatory requirements for specific schedules
No requirements 1
There are requirements for testing independent of a numerical rating system 2 2
Total Score: 17
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested) 2

©University of Vermont, Rev. 2 – Confidential 141

 Ventilator procedure
Estimated time: 50 minutes

Equipment information
Control number:____________________________________ Hospital:_ __________________________________________
Manufacturer:______________________________________ Model:_____________________________________________
Serial number:_ ____________________________________ Location:___________________________________________

Test information
Technician:________________________________________ Date:_______________________________________________
Test type: Incoming_ ________ Post repair_________
Test equipment needed: ISA 601 Electrical Safety Analyzer (or equivalent)
VT PLUS HF Ventilator Analyzer (or equivalent)
Test lung (such as ACCULUNG)
Hoses and connectors to connect to VT PLUS HF

Test Result
Pass Fail N/A
Physical condition
Device is clean and decontaminated
No physical damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, and warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
Electrical safety
Ground wire resistance < 0.3 W
Chassis leakage < 100 µA NC,
< 500 µA SFC
Patient leakage current < 100 µA B and BF
< 10 µA CF
Patient lead leakage current – isolation test < 100 µA BF
(mains on patient applied part) < 10 µA CF
Insulation test (optional) 500 V < 2 MW
Preventive maintenance
Clean vents and filters
Replace tubing
Replace battery every 24 months
Complete model-specific preventive maintenance

continued on page 143

142 ©University of Vermont, Rev. 2 – Confidential

 Ventilator procedure
Estimated time: 50 minutes

continued from page 142

Test Result
Pass Fail N/A
Performance testing
Verify unit operates on battery
Gas cylinders and regulators
Hoses, tubing, and connectors
Volume accuracy ± 10 %
Respiration rate
I:E ratio
Pressure accuracy ± 10 %
PEEP
O2 accuracy ±2%
Alarm function
Complete model-specific performance testing

©University of Vermont, Rev. 2 – Confidential 143

Physical condition yokes. Disconnect hoses from the hospital’s gas
Check the physical condition of the device, as system. With the ventilator turned off, open
described in the General Equipment Procedure. each cylinder. Note the pressure in each cylin-
der. Replace any cylinders with less than
Electrical safety 500 psi. Close the cylinders. The pressure
should remain steady on the cylinder gauges.
Perform electrical safety checks as described in Hoses, tubing, and connectors: Check
Chapter 5, Electrical Safety. Check ground wire the condition of external hoses, tubing, and
resistance and chassis leakage. connectors. Check for signs of wear such as
cracking or dry rot. Ensure all connectors are
Preventive maintenance tight.
Clean vents and filters: Inspect vents and air Volume accuracy: Turn on the VT PLUS HF
filters. Clean or replace filters as necessary. and allow it to warm up. Ensure that all hoses
Ensure that filters are installed properly. are disconnected from the analyzer and then
Replace tubing: Replace internal tubing and press the soft key to zero the pressure and flow.
filters as necessary. Follow the manufacturer’s Press ‘8’ (‘SETUP’) on the analyzer to enter the
guidelines for tubing replacement. setup menu. Use the arrow keys to highlight
Replace battery: The battery should be ‘Gas Settings’ and then press the ‘MODIFY’ soft
replaced every 24 months. Replace if necessary. key. Use the arrow keys to highlight ‘GAS TYPE’
Complete model-specific preventive main- and press the ‘MODIFY’ soft key to select the
tenance: Refer to the monitor’s service manual gas used in the ventilator. Most commonly, air
for preventive maintenance tasks specific to the or O2 will be used. Enter the gas temperature,
device. Complete the preventive maintenance ambient temperature, and relative humidity of
per manufacturer’s procedure. the gas as necessary. To change the settings,

Performance inspection
Verify unit operates on battery: Check that
the ac power indicator is lit when the power
cord is plugged into an outlet. Unplug the ac
power cord and perform the remainder of the
functional test on battery power. The ac power
indicator should go out when the power cord
is unplugged and the battery indicator should
light. Be sure to plug the power cord in at the
conclusion of the test.
Gas cylinders and regulators: Check the
condition of gas cylinders and regulators.
Remove each cylinder and verify that the index
pins are present on the cylinder yoke. Verify
that cylinders have the correct color coding and
labeling and that the cylinders are within their
expiration dates. Replace the cylinders in their

Ventilator and test lung connected to the VT PLUS HF.

144 ©University of Vermont, Rev. 2 – Confidential

highlight the parameter and then press the Respiration rate: Set up the VT PLUS HF
‘MODIFY’ soft key. Enter the new value using analyzer and the ventilator as described above.
the number keys on the front of the analyzer The respiration rate can be read on the volume
and then press the ‘ENTER’ soft key. Press the screen of the analyzer.
‘BACK’ soft key to return to the measurement I:E ratio: Set up the VT PLUS HF analyzer and
screen on the analyzer. Match the VT PLUS HF the ventilator as described above. The inspi-
correction mode setting to that used by the ration to expiration ratio can be read on the
ventilator manufacturer (usually found in the volume screen of the analyzer.
ventilator service manual). Pressure accuracy: Press ‘1’ (‘PRESSURE’)
Connect a patient breathing circuit to the on the VT PLUS HF to switch to the pressure
ventilator. Connect the Y piece of the patient screen. If the ventilator has a pressure control
tubing to the high flow inlet on the right side of mode, enter a pressure of 40 cmH2O and a rate
the VT PLUS HF analyzer. Set up the test lung of 6breaths/min, otherwise enter a tidal volume
(such as ACCULUNG) resistance and compliance of 1000 mL and a rate of 6 breaths/min. Start
settings by selecting a pair of resistance and the ventilator. Compare the pressure measured
compliance settings that most closely matches on the analyzer with the pressure displayed on
the patients served by the hospital owning the the ventilator. The measured pressure should
ventilator (e.g. resistance = Rp20, compliance = be within 10 % of the displayed pressure. For a
C20). Connect the test lung to the flow exhaust displayed pressured of 40 cmH2O, the measured
on the left side of the analyzer. pressure should be between 36 cmH2O and
Enter the volume screen on the analyzer by 44 cmH2O.
pressing ‘2’ (‘VOLUME’). Set up the ventilator PEEP: Put the ventilator into volume control
with a tidal volume of 200 mL, a breath rate of mode with a tidal volume of 1000 mL and a
25 breaths/min, and an inspiration to expira- rate of 6 breaths/min. Begin ventilating. Watch
tion ratio of 1:2 and start the ventilator. The the pressure airway pressure gauge during
ventilator may take a few breaths to stabilize ventilation. Following expiration, the pressure
the delivered volume. The measured volume gauge should return to zero. Set the PEEP
should be within 10 % of the set volume. For a (post expiratory end pressure) to 10 cmH 2O.
set tidal volume of 200 mL, the measured tidal The airway pressure gauge should drop to
volume should be between 180 mL and 220 mL. 10 cmH2O following expiration instead of
Repeat the measurement with a tidal volume of returning to zero. Measure the actual PEEP
1300 mL and a rate of 8 breaths/min. The tidal using the VT PLUS HF. PEEP is displayed on the
volume should be between 1170 mL and pressure screen.
1430 mL.

©University of Vermont, Rev. 2 – Confidential 145

 O2 accuracy: Before measuring oxygen con- Close the O2 cylinder and disconnect the
centration using VT PLUS HF, Ensure the sensor pipeline. The low O2 pressure alarm should
displays the oxygen concentration at 100 % O2. activate. Reconnect the pipeline and clear the
If not, perform the oxygen calibration according alarm. Repeat this for other gases if necessary.
to the VT PLUS HF operator’s manual. Set up the ventilator with a tidal volume of
If possible, remove the O2 sensor from the 1000 mL, a rate of 6 breaths/min, and an I:E
breathing circuit and allow the sensor to sit in ratio of 1:2 and start the ventilator. Note the
room air for approximately 5 minutes. The O2 maximum airway pressure during ventilation.
reading in room air should be 21 %. Calibrate Set the high pressure limit about 10 cmH 2O
the sensor according to the ventilator manu- below the peak inspiratory pressure. If the
facturer’s recommended procedure if possible. Peak inspiratory pressure is 40 cmH2O, set the
Return the sensor to the breathing circuit. high pressure limit to 30 cmH2O. Verify that
Set up the ventilator with a tidal volume of the ventilator immediately stops delivering the
1000 mL, a breath rate of 6 breaths/min, and breath when the pressure limit is reached and
an inspiration to expiration ratio of 1:2 and start allows the breath to be exhaled. Verify that the
the ventilator. Press ‘3’ (‘O2’) on the VT PLUS HF alarm activates. Return the high alarm limit to
to switch to the O2 screen. The O2 percentage its previous setting and clear the alarm.
is displayed on the VT PLUS HF. Compare this Disconnect the inspiratory limb of the patient
value to the value displayed on the ventilator. circuit from the ventilator. The low pressure
The measured O2 percentage should be within alarm should activate.
2 digits of the displayed value. In 100 % O2, Complete model-specific performance
the measured oxygen percentage should be at testing: Refer to the service manual for perfor-
least 98 %. mance inspection tasks specific to the device.
Alarm function: Check that all alarms are Complete the performance inspection per
functional and that the volume is adequately manufacturer’s procedure.
loud. Ensure that appropriate visual indicators Return to service: Before returning to use,
are functioning. return any settings that were adjusted to their
Remove the O2 sensor from the breathing original settings. Ensure the volume of the
circuit and expose it to room air. Set the low O2 audible alarms is loud enough to be heard in
alarm to 30 %. Verify that the alarm activates. normal operating conditions. Plug in the power
Return the O2 sensor to the breathing system cord to ensure the battery remains charged.
and return the alarm to its previous setting. Standards are used to give a baseline

146 ©University of Vermont, Rev. 2 – Confidential

APPENDIX 1: Standards

performance that needs to be met in order to requirements in addition to the parent standard.
ensure the safe use of medical equipment. These standards are general in nature, like the
A medical equipment maintenance program parent standard, and are applicable to all medi-
needs to meet or exceed all local standards. cal equipment. Particular standards contain
All relevant standards should be reviewed to requirements that are exceptions to the parent
ensure program compliance. The following and collateral standards. These types of stan-
Chapter discusses some standards that biomed- dards are specific to a device type. IEC 60601
ical personnel should be familiar with. is the parent standard. Collateral standards are
labeled as 60601-1-xx and particular standards
IEC 60601-1 are labeled as 60601-2-xx, with xx represent-
The International Electrotechnical Commission, ing a specific document.
IEC, is a worldwide organization that pro- IEC 60601-1 is mainly used by manufacturers
motes global standardization in the electronics of medical equipment. Medical equipment that
industry. IEC 60601-1, titled Medical electri- is manufactured to this standard has been sub-
cal equipment - Part 1: General requirements jected to rigorous safety and performance tests
for basic safety and essential performance, and has met quality assurance specifications.
addresses the issues of safely designing medi-
cal equipment and serves as the foundation for IEC 62353
safe manufacturing practices. This standard is IEC 62353 is an international standard pub-
mainly used in the design and manufacture of lished by the International Electrotechnical
medical equipment. Commission, a worldwide organization that
In 2005, the third edition of 60601-1 was promotes global standardization in the elec-
published. The object of the standard is to pro- tronics industry. The standard deals with the
vide general requirements for safety of medical testing of medical equipment before first use,
devices and to provide the basis for more spe- after servicing, or periodic safety inspections.
cific standards. This edition combines product The standard specifies how to test for elec-
requirements with manufacturing processes trical safety and gives limits for acceptable
such as risk management. This edition also measurements. Specific tests for measuring the
addresses the concept of essential performance, protective earth resistance, leakage current,
parts of the equipment operation that directly applied part leakage current, and insulation
affect the safety of the patient and operators. resistance are outlined. These terms are
The rationale behind the standard is to iden- defined as:
tify specific hazards associated with medical Protective earth resistance: Sometimes
equipment and to define an acceptable level of referred to as ground wire resistance. Resis-
risk for each hazard. Additionally, it provides tance between any conductive part of the
an objective test to determine if the risks have equipment and the protective connector of
been acceptably minimized, while avoiding the main power supply plug, the protective
requirements defining how to minimize risks. connector of the appliance inlet, or the protec-
This standard is not intended to be used tive conductor permanently connected to the
alone, as it addresses general safety issues supply mains.
applied broadly across medical equipment. More Equipment leakage current: Current flow-
specific standards need to be applied to specific ing from the supply mains to earth through
types of medical equipment. The 60601 family the protective earth conductor and accessible
of standards contains collateral and particu- conductive parts.
lar standards. Collateral standards contain

©University of Vermont, Rev. 2 – Confidential 147

 Applied part leakage current: Sometimes systems, and emergency management. It is
referred to as lead leakage. The current flowing important to note that this is a voluntary stan-
from the supply mains and accessible conduc- dard. However, many localities have adopted
tive parts to the applied parts, or patient leads. NFPA 99 as part of their fire codes.
Insulation resistance: The resistance of NFPA 99 includes a Chapter on electrical
the insulation between the supply mains and equipment that is of particular interest to bio-
protective earth, the supply mains and acces- medical equipment technicians. This Chapter
sible conductive parts, or the supply mains and specifically covers the performance, mainte-
the patient leads. The insulation resistance is nance, and testing of electrical equipment used
calculated by applying a voltage and measuring within the hospital. Numerical criteria are given
the resulting current. for electrical safety testing. NFPA 99 section
IEC 62353 sets specific limits for electrical 8.4 states that the ground wire resistance of
safety testing. The protective earth resistance medical equipment should be less than 0.5 W. It
should not exceed 300 mW. Leakage current for goes on to say that the chassis leakage current
Class I medical equipment should not exceed should not exceed 300 µA.
500 µA using the direct measurement method;
leakage current for Class II medical equipment The Joint Commission
should not exceed 100 µA. The Joint Commission is a regulatory body
Electrical safety testing is discussed in detail that evaluates and accredits health care
in Chapter 5 of this manual, Electrical Safety. organizations in the United States. The Joint
IEC 62353 goes on to further specify that safety Commission’s mission is to improve the safety
related functions of the equipment are to be and quality of healthcare provided to the public.
inspected. The standard does not specify which Currently, a system of unannounced surveys is
functions need to be tested or how often, only used to promote continued compliance of the
that the device functionality should be tested. Joint Commission’s regulations.
The standard also specifies that safety inspec- The Joint Commission releases National
tions need to be documented. Patient Safety Goals annually relating to per-
tinent healthcare quality issues. The National
NFPA 99 Patient Safety Goals are eventually rolled into
The National Fire Protection Agency is an the Joint Commission’s regulations. The Joint
international organization that advocates the Commission’s regulations include a Chap-
consensus of codes and standards for fire, elec- ter on the Environment of Care. This Chapter
trical, and building safety. NFPA building codes specifically deals with medical equipment, its
have been adopted in the United States. The maintenance, and how to minimize its risk. One
standard NFPA 99, Standard for Health Care common benchmark that is used in the United
Facilities, establishes criteria to minimize the States is the completion of scheduled mainte-
risk of fire, explosion, and electrical hazards in nance. The Joint Commission requires that
health care facilities. 100 % of life support equipment receive its
NFPA 99 covers nearly all aspects of fire scheduled maintenance and that at least 90 %
safety in the hospital environment including of non-life support equipment receive its sched-
building electrical systems, vacuum and gas uled maintenance.

148 ©University of Vermont, Rev. 2 – Confidential

Author’s biographical information

J. Tobey Clark, MSEE CCE, is the Director, Michael W. Lane, MBA, is the Associate
Instrumentation and Technical Service, at Director, Instrumentation and Technical
the University of Vermont. He leads the Services, at the University of Vermont.
Technical Services Program, a 26 hospital He manages the operations of Technical
shared service clinical engineering program Services Program, a 26 hospital shared
serving Vermont, upstate New York, and service clinical engineering program serving
northern New Hampshire. Tobey also directs Vermont, upstate New York, and northern
the Instrumentation & Model Facility (IMF) New Hampshire. He holds Certification as a
which designs, develops, fabricates and Quality Manager from the American Society
services custom research instruments for for Quality. Michael is a member of the
the University of Vermont community. He Vermont Council for Quality and serves as a
has a faculty appointment in the School of state examiner for Performance Excellence.
Engineering and the College of Nursing Michael is a member of the Association for the
and Health Sciences where he teaches Advancement of Medical Instrumentation
medical instrumentation courses. Tobey is and of the American Society for Field
involved in a number of professional activities Service Managers.
including serving as a board member of the
ACCE Healthcare Technology Foundation
and as an advisor to the World and Pan
American Health Organizations. He was the
2002 recipient of the Clinical/Biomedical
Engineering Career Achievement award
from the Association for the Advancement
of Medical Instrumentation and the 2008
Professional Achievement in Management
award from the American College of Clinical
Engineering. Tobey is currently supported by
Leah Rafuse, BSME, is a clinical engineer
with Technical Services Program, a 26
several grants related to medical technology
hospital shared service clinical engineering
education and international clinical
Program, at the University of Vermont. Leah is
engineering exchange.
responsible for clinical engineering services
for eight hospitals in upstate New York. Leah
is a graduate of the University of Vermont’s
engineering program. Prior to taking over
clinical engineering services in New York,
Leah worked with Technical Services Program
as a biomedical equipment technician,
specializing in anesthesia equipment.
©2009 Fluke Biomedical.
1/2009 3276553 C-EN-N Rev A