BMET ENTRY LEVEL

GUIDEBook

This helpful Guidebook is really Important for the “Biomeds Want to Be”
for it contains the necessary course lectures and vital information to start,
the basic knowledge in classification, operation of common general
medical equipment, devices and instruments in healthcare facility.
The importance of maintenance program and standards.

Exclusively Prepared
ExclusivelyByPrepared
BMET CONNECT
by
BMET CONNECT
Training and Tech Support Group

Page | 1
Table of Contents
1. Purpose of the Guide

2. Academic Background

3. Basic Medical Equipment in Hospitals

4. Nomenclature System (UMDNS, GMDNS System) (Book 2)

5. Medical Equipment Maintenance System Standards

6. Accreditation Agencies in Different Countries

7. What is Preventive and Corrective Maintenance Program?

8. Philippine Settings according to local Government and Alignment to What Standards

9. Electrical Safety Testing

10. Acronyms and its meaning in Biomedical Engineering Technology

© Copyright 2024 BMET CONNECT

No part of this Guidebook shall be copied or reproduced
unless with written permission from
BMET CONNECT® Training and Tech Support Group

Page | 2
1. Purpose of the Guide

How to Prepare Yourself into this New Field of Career in Healthcare Technology
Industry?

The advancing pace of technology is always double or more than what we expect in the
next generation to come. To become a Biomedical Equipment Technician or BMET, one
must have a great interest for this job. There are three things to consider: a keen
observer, having a time to do some tinkering in mechanical, electrical and electronics
devices, analytical thinking-an attitude to analyze certain things that interacts with
matter. Being a good observer is a must to practice critical thinking. A Biomed attitude
develops first for having a desire to do the job of a scientist. When is the time to pursue
your career as Biomed? The author of the book tells the story of his colleague career
path. During high school days, he proved his best interest in science subjects,
particularly Biology. The young man showed outstanding grades in Biology and Physics
then earned a successful result in many Science Quiz Contests, both regional and
national. He won more than couple of medals in Science Quiz Contests in his school
during foundation anniversary and sent to many district schools, regional and national
Science Quiz Bee Contests. Then entering college, took electronics engineering as a
course going to career pathway he wants to pursue, he continuously experimenting,
building electronics projects kit from Heath kit U.S.. His father ordered these kits from

Page | 3
United States as Gifts for having a good grade in university. After this he was able to
apply for a local company that distributes scientific and medical instruments, his first job
assignment is to clean a dozens of Microscopes

and Otoscopes. He was employed by a Nikon® Microscope and Welch Allyn® Distributor.
After his job locally, he was hired by a multi-national company in U.S., then continued his
studies there until he passed the licensing exam to become a Certified BMET.

2. Academic Background
Biomed or BMET does not require a mandatory engineering course as pre requisite, but requires
background in electronics or electrical trade courses. Some Biomeds have degree in Mechanical,
Chemical and Industrial Engineering. But what is appropriate is the electrical and electronics
background. Since medical equipment is composed of multi-disciplinary technical principles like
Electrical, Electronics, Hydraulics, Pneumatics, Thermodynamics and Biochemistry, the
complexities is really exhausting and brain boggling. To become a Biomed one must be ready to
the complexities and intricacies of the job.

Page | 4
3. Basic Medical Equipment in Hospitals

There are many medical devices, equipment and instruments in healthcare facilities particularly in
hospitals, some numbers or units also in medical diagnostic clinics, laboratories and health
centers. But these medical equipment varies according to their use and purpose, this is to classify
them into 2 groups: Diagnostics and Therapeutics. The two groups are also categorized according
to the specific department in hospitals that they belong to. To subdivide the group these are:
Diagnostics Equipment: X-Ray, Bone DEXA Densitometer, Ultrasound, CT Scan, MRI into Medical
Diagnostic Imaging, Clinical Laboratory: Bioanalytical systems are: Hematology, Biochemistry
Analyzers, Sub-Units including Centrifuges, Waterbaths, Balances and Weighting Scales, Pipettes

Page | 5
or Pipetors, Biological Safety Cabinets, Oven, Dryers, Mixers and Shakers. Life-Support Equipment
such as Ventilators, Anesthesia Machines (Also belong to Therapeutics), Hemodialysis Machines,
Units, Infant Incubators and Respiratory Therapy Devices. For Sterilization, Infection Control:
Autoclaves, UV Disinfectors, Sterilizers using dry and liquid, chemical solutions and sterilants.
Other lines or sub fields: Opthalmology. Dental, Physical, Occupational Therapy or Rehabilitation
Equipment. Another High Specialty under Therapeutic are: LINAC-Linear Accelerators, Cobalt
Therapy, Brachytherapy and Radiotherapy Systems. For Surgery and Operating Rooms:
Electrosurgical Units, Electrocautery, Lasers for Surgery, Cryosurgical Units, Endoscopy Systems,
Operating Microscopes, Robotics and Computer-Assisted Surgery. Most minor medical devices
are: Aspirators or Suction Units, Nebulizers, Patient Weighting Scales and Sphygmomanometers-
Blood Pressure Apparatus, Ultrasonic Cleaners, Paraffin Baths in Physiotherapy. ICU and O.R.
Rooms: Physiological Patient Monitors, Infusion Pumps both located in Patient Wards, O.R. and
ICU’s. In Clinical Laboratory, a lot of minor equipment and devices are also included and must be
maintained by a qualified in-house BMET-Biomedical Equipment Technicians.

3.a Aspirator (Suction Machine)

Page | 6
Aspirators or Suction Machines have different types and uses, the photo above is a sample of
most common portable aspirator for general suction applications. There are more advanced
types like Thoracic for Respiratory Care and more features like high pressure and high capacity
types for Operating Room use.

3.b Nebulizer

Another motorized or motor-equipped medical device is the nebulizer. This unit is indispensable
in every Emergency Room, ICU’s, Patient Wards and even other department in hospitals that
requires patient breathing apparatus such as n Operating Rooms or Hemodialysis Rooms or X-
Ray Department. Certain advanced technology was employed in designing and manufacturing a
Nebulizer. There are Ultrasonic Nebulizer where ultrasonic transducer is incorporated to achieve
more molecular or micro size nebulization and less noise motor operation, see right photo.

Page | 7
3.c Sphygmomanometer (BP Apparatus)

This medical apparatus or device plays a vital role in everyday life of both patients and healthcare
personnel mostly doctors and nurses. For it measures, monitors the patient’s blood pressure for
required period of time, during regular or daily monitoring and even in emergency cases. It is the
first line of diagnostic procedure. There are many types of BP Apparatus and Devices from simple
Aneroid or Gauge-type (See Below Photo), Mercurial-Type (Above Photo) which is now discarded
by FDA and Government Healthcare Regulatory Agencies due to its toxic components that may
harm the people and the environment. Another advanced types are electronic
sphygmomanometers (Below Photo), Non-Invasive Blood Pressure monitors (NIBP), Invasive or
In-Vivo Blood Pressure Monitors.

Page | 8
3.c Sphygmomanometer (BP Apparatus)

Some advanced models or types is a Wrist-Worn type (Not in Photo) it uses oscillometric
principles, the pressure transducer is built-in on its wrist cuff that should be properly positioned
to pulse location in patient’s wrist.

Page | 9
3.d Pulse Oximeter (Electro-Medical)

This medical device is valuable in hospitals and other healthcare facilities. The device is
indispensable and very handy for doctors, nurses and clinicians. The Pulse Oximeter is the results
of advancement in technology in determination of pulmonary blood gases. ABG or Arterial Blood
Gas Machines manufacturers incorporates Pulse Oximetry in their latest units.

Page | 10
3.e ECG (Electrocardiograph) Electro-Medical

The Electrocardiograph (ECG) is invented by Wilhelm Einthoven, its primary functions in diagnosis of hearth
rate, rhythm and underlying condition of the heart is really important to the doctors who interpret the
abnormalities, the electrophysiological changes and to conduct diagnosis by reading the graphical
recordings from various limbs and chest leads, from LI-II-III, AvR, AVl, AVf or Chest Leads V1-V2-V3-V4-V5-
V6. There are many types such as 1-Channel (See Fig.9a) and 3-Channel or Multi-Channel (See Fig.9b).

Page | 11
3.f Defibrillator - Therapeutic, Electro-Medical

Defibrillator is classified as Therapeutic Medical Equipment under critical class. This unit is highly
needed in most ICU’s-Intensive Care Units in hospitals, for it has a life-saving purpose. When
patient is in code “blue” or need a cardioversion and resuscitation, this machine is really a miracle
worker for it has the capability of reviving patients who are in critical condition. The maintenance
tasks for this equipment is the following 1) Check the paddle contacts for any film or residue of
conductive or electrolyte gel that is dried. The dried gel can cause unwanted electrical resistance
that may impede the flow of current going to the patient during defibrillation procedures. 2) Check
if the electrical output energy in Joules are within the proper ranges and tolerances. 3) Check if
the built-in ECG (Electrocardiograph) runs normally and within the proper amplitude and
sensitivity range ad its recorder speed is normal. Other important test for Defibrillator is electrical
safety, to check for any unwanted leakage current and grounding integrity.

Page | 12
3.g Electrosurgical Unit (ESU) Electro-Medical

ESU-Electrosurgical Unit is a vital equipment in surgical suites or operating room in hospitals. It

aide’s doctors in surgery procedures. It is similar to the principles of high frequency welding, but
not the same in application of RF frequency in medical field. It consists of different modes such as
CUT in cutting mode and COAG in coagulation mode. The output energy for the tissue to cut
depends on the current output setting as decided by the surgeon. There are specific preventive
maintenance tasks for ESU equipment, 1) To check the output current or energy in WATTS through
the use of ESU Output Analyzer. This calibration device detects current output from ESU and reads
its output, both modes CUT and COAG, and BLEND output cables are connected to this analyzer
while pressing the footswitch. There are (2) Pencil Electrodes with Blades for CUT and COAG
Modes and the patient Plate as ground return contact for patient.

Page | 13
3.h Sterilizer (Autoclave) Sterilization

Sterilizer more technical term, so-called Autoclave in clinical or healthcare facilities is the basic
equipment in infection control for it helps the O.R. or Surgery Department to decontaminate
certain surgical items, materials or instruments that is use for patient’s surgical procedures.

Page | 14
3.i Anesthesia Units (Analgesia) Life-Support, Therapeutic

Anesthesia machine or Analgesia unit is one of the most important Life-Support (Therapeutic)
Medical Equipment in Surgery or Operating Room Department. For it is the first equipment for
giving the patient a so-called “goodnight sleep” while undergoing surgical procedures. The
patient will be sedated fully in major operation by placing an inhalation mask into the mouth, the
anesthesiologist will open the vaporizer dial knob that releases the anesthetic gases that will be
inhaled by the patient until the procedure is completed. The Vaporizer is the vital part of the
anesthesia unit, it has many types of anesthetic gases namely: Nitrous Oxide, Isoflurane,
Sevoflurane, Halothane and Desflurane. Other anesthetic gas is discarded already for clinical use
due to its flammable and explosive effects such as Ether. The parameters involved when calibrating
the main anesthesia machine are: Oxygen Flow and Pressure, Nitrous Oxide Flow and Pressure,
and Vaporizer output in percent.

Page | 15
3.j Infant Incubator ( Life-Support, Therapeutic)

Infant Incubator is most important in Pediatric Department in hospitals, for it provides a thermo
effect to babies that requires sufficient incubation period after birth. Some babies and infants are
premature and small enough, suffers from hypothermia that needs immediate therapy and relief
to the newly born babies.

Page | 16
3.k Ventilator (Life-Support, Therapeutic)

One of the major life-support equipment under critical class medical equipment and device is
infant and adult ventilator. This machine supports breathing process to the patient who is not
capable of breathing by itself voluntarily. The so-called mechanical ventilator saves many patient
lives in the hospital mostly located in the ICU’s. This indispensable unit requires proper
maintenance and calibration regularly. The parameters that involves in calibration and
performance testing of Infant and Adult Ventilator are: Oxygen Pressure and Flow, Oxygen
percentage, breaths per minute I:E Ratio, Breathing Cycles, etc. there are various adjustments to
compensate the lung compliance of specific patient which are located in control panel. To
maintain this machine, the Biomed needs test tools and verification devices such as Ventilator Gas
Flow analyzer, manual Wright’s Respirometer, Oxygen Analyzer and Timer.

Page | 17
3.l Water Bath (Clinical Laboratory)

Water Bath is one of the basic clinical laboratory equipment that is essential to clinical laboratory
department in hospitals, this piece of equipment is required to maintain patient’s specimen,
samples, reagents into 37 Deg. C (Human Body Temperature). This unit requires pure water usually
distilled to be poured into water bath basin or chamber. Using water other than distilled will cause
the buildup of scales or corrosion.

Page | 18
3.m Microscope (Clinical Laboratory)

Page | 19
3.n Pipettor/ Pipette (Clinical Laboratory)

Pipette or Pipettor requires periodic maintenance and calibration for it precisely aspirates and
dispenses certain biochemical solutions, reagents, patient samples, biological liquid samples and
analytes.

Page | 20
3.O Spectrophotometer (Clinical Laboratory)

Spectrophotometer is the parent of Biochemistry Analyzer, where Bioanalytical Instruments

evolved from. Spectro-means light bands while Photometry means light measurements. This
machine employs light sources of UV and Visible Light, a monochromator mirror with gratings
that disperses light, passes into mirror, lens then to slit. The analyte or specimen is prepared in a
test tube or cuvette then mixed with certain biochemical solutions or reagents, that reacts with
the light. When certain wavelength of light source is used to pass through the specimen or sample,
an absorbed light depends on the density of liquid in a sample then reacts when dense or passes
the light if low density. Then light entered into the test tube or cuvette with specific sample then
into the photodetector tube that converts light energy into electrical pulses that will be processed
by a computer for final measurements, then send to display monitor either analog or digital. Some
advanced models have printer/recorder; others can be interfaced serially into a desktop PC
computer. To further discuss spectrophotometry principles, Biomed should learn the Beer-
Lambert’s Law which applies to calorimetric measurements. The following page explain the details
of computing a spectrophotometric measurement.

Page | 21
3.O Spectrophotometer (Clinical Laboratory)

The reference solution or “Blank” sample usually Water is required in order to calibrate
the Spectrophotometer before performing any colorimetric analysis of patient sample.
Remember the rules: Blank Sample for Water T-Transmittance = 0 or ZERO %, A-
Absorbance = 100 % For Air, usually the same rule is applied 100 % Transmittance, 0 or
No Absorbance reading acquired.

Page | 22
3.P Centrifuge (Clinical Laboratory)

Centrifuges are devices in tandem with microscopes in clinical laboratory, the patient
samples usually of blood or urine are collected into test tubes, cuvettes or capillary tubes,
placed in the rotor with sample wells, rotates into certain or specific speed in RPM as
required to separate fluids or liquids from solids. A whole blood sample is place in a
centrifuge to separate cells from plasma. This will prepare the blood sample for staining
into glass slides to manually count the cells. Other parts of the centrifuged blood is for
feeding into hematology or blood chemistry analyzer.

Page | 23
3.Q X-Ray Radiographic Unit (Medical Imaging)

X-Ray Machine is the first line of diagnostic procedures in healthcare facilities like Blood
Testing. This unit is capable of seeing the underlying anatomical structures of human body
as well the structure and image of different organs inside our bodies. X-Ray Machines
employs or apply an ionizing type of radiation to penetrate even the dense tissues and
organs.

Page | 24
3.R Ultrasound Scanning Units (Medical Imaging)

Page | 25
4. Medical Equipment Nomenclature System
The UMDNS – Universal Medical Device Nomenclature System, ECRI is the creator of
these codes to become a standard worldwide nomenclature. It is a standardized terms
and definitions that has been officially adopted by many nations. A standard
nomenclature and computer coding system for medical devices. Its main purpose is to
facilitate the identification, filing, processing, storing, retrieving, transferring and
communicating data of medical devices. - ECRI

GMDNS The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed
descriptors and is the leading global standard for the naming, classification and categorization of
medical device products. The GMDN Database lists all the Terms, which are currently available to
name and describe medical devices, although new Terms are regularly issued to cope with new
medical device innovations. The GMDN is owned and managed by the GMDN Agency, a non-
profit organization. Anyone can register for free as a member on the GMDN website to access
and use any GMDN Term. The GMDN provides Healthcare Professionals, Regulators,
Manufacturers and others with a common language to communicate and share information. To
find out more about the GMDN and its history. – gmdnagency.gov

To check the list of UMDNS Nomenclature System – Please See List at the end of the
Guide.

Page | 26
5.Medical Equipment Maintenance System Standards
For the past few decades, medical equipment manufacturers are continuing their
development to their design and efficiency to suit the demanding needs of healthcare
facilities around the world. The inclusion of computer software, upgrading of hardware
to make the performance of each medical equipment to optimum level. The advancing
technology of medical devices are one of the big developments in healthcare technology
industry, for it helps to increase the efficiency of healthcare workers particularly the
doctors, nurses, radiologic technologists and medical technologists. Another side of this
Is the pacing of maintenance system and its implementation? The local and international
Medical device regulatory and standard agencies and organizations have following
adaption to this increasing development of technology of medicine and healthcare. One
of the most active non-profit organization that influence the compliance of standard
medical device maintenance program is the ECRI-Emergency Care Research Institute. ECRI
IPM-Inspection and Maintenance System is patient safety-focus maintenance program.
JCAHO-Joint Commission on Accreditation of Healthcare Organizations in U.S., JCI-Joint
Commission International, is an accreditation body that accredits more than 22,000 U.S.
Healthcare Organizations and Programs. NFPA 99 (National Fire Protection Code) The
regulations called Healthcare Facilities Code covers the safety of healthcare facilities from
fires that originates from equipment, appliances and related electrical machineries,
including medical gas and vacuum systems that is not regularly inspected and maintained
by some qualified technical personnel. Some of the code features including the
provisions for the installation, inspection, maintenance of all healthcare facilities including
hospitals, nursing homes and limited care settings. See NFPA 99 Healthcare Facilities Code
Handbook Series 2012-2015, downloadable from NFPA 99 website.

AEM-Alternative Equipment Maintenance Program, this maintenance system is based on

manufacturer’s specifications. It doesn’t allow alteration, modification and customization
of medical equipment and devices that will be included in commissioned hospital’s asset
list and prior to preventive maintenance program and calibration. In-house Biomedical
Equipment Technicians both from private and government hospitals will benefit on this.

Other Maintenance system standards are: Predictive Maintenance and Proactive

Maintenance. Both maintenance systems are effective provided you have all the necessary
test tools to inspect, to calibrate, to monitor the normal performance of medical
equipment, devices and instruments. The best approach of these two maintenance
systems, you can forecast the downtime of specific device before failure occurs. But the
Maintenance system cost more and the expertise of Biomeds is high, in order to conduct
a proactive and predictive maintenance program. Monitoring and measuring equipment

Page | 27
downtimes should be done by determining the MTBF or Mean Time Before Failure, this
task is also applied in reliability engineering.

6.Accreditation Agencies in Different Countries

There are many accrediting agencies, bodies and organizations all over the world. Most
of them are implementing and adopting various quality system standards, it depends on
what country it originates. In the Philippines, ever since the medical equipment population
rise in local healthcare facilities, the maintenance system standards also grows. The
standard of healthcare facilities and the maintenance program are under the monitoring
of DOH-Department Health, and some most-restricted medical equipment are channeled
to FDA-Philippines. The agency is regulating new medical device entering into the country
and regulatory framework for health, safety, efficacy and consumers market and reselling
locally is highly regulated that must pass through series of tests.

In other countries, like in U.S., FDA is also one of the main regulatory bodies or agencies
that implements the same conditions in maintenance program for medical devices, for
radiology equipment in the Philippines, FDA Performance Testing is a mandatory
requirement prior to LTO-License to Operate application and renewal process.

Page | 28
7. What is Preventive and Corrective Maintenance Program
The two (2) Important tasks and procedures in any medical equipment maintenance
program:

PREVENTIVE MAINTENANCE – is a regular maintenance task of a Biomed whether in-

house or from ISP-Independent Service Provider, with detailed procedures according to
the equipment manufacturers and as an advice of local and international “legitimate”
maintenance and regulatory agencies, controlling and monitoring the effective
maintenance program for healthcare service organizations, with wide scope of
accreditation rules and policies. Among these are: ECRI-Emergency Care Research
Institute, who implemented the IPM, JCI, NFPA 99, ASHE, FDA.

CORRECTIVE MAINTENANCE – is a reactive process or actions to be taken when any or

many machines, medical equipment or devices experience a downtime, breakdown or
failure. This is also the main responsibility of a BMET whether in-house or ISP-Independent
Service Providers service personnel. This involves repair, adjustments and any technical
corrective actions in order to bring back the device or unit into active service mode in
healthcare facilities particularly in hospitals.

Page | 29
8. Philippine Settings According to Local Government and Alignment to What Standards?
As a long time BMET in healthcare facility, both locally or here in the Philippines, there is
no known alignment to a particular medical equipment or devices maintenance standards.
The hospital maintenance setting either in-house or with outsource service provider or
ISP-Independent Service Provider is contracted, no such alignment to specific national or
international standard is observe. But based in long term practice, Biomeds in the
Philippines are conducting preventive maintenance as per recommendation of equipment
manufacturers found in the service manuals. For electrical standards in healthcare facility
here most receptacles or AC power outlets are patterned to U.S. standards preferably NEC
Regulations. The AC Line Voltage and Frequency is only the different, in U.S.110-120V 50
Hz., while here is 220-230V, 60 Hz. But for other regulations like transformer
configurations, grounding system and electrical safety testing is always the same. For
practicing Biomeds here to conduct an electrical safety program is to follow the IEC
60601-1 Standards and can shifted to IEC-62353 Standards for Medical Devices Electrical
Safety Testing, practice in healthcare facilities in the Philippines.

Page | 30
9. Electrical Safety Testing
Electrical Safety Testing is one of the most important elements in conducting a regulatory-
compliant medical equipment and devices preventive maintenance program. Besides for
patient safety concerns it prevents the healthcare facility and its staff from the dangers of
hazardous electrical leakage currents, and from unwanted sparks that may result into
explosion or fire. The Electrical Safety Practice Manual for local Biomed Practitioner can
avail from BMET CONNECT Training and Tech Support Group. You can send your message
to BC FB Group Messenger to request your copy of the manual.

Page | 31
10. Acronyms in Biomedical Engineering Technology
AAMI- Association for Advancement in Medical Instrumentations U.S.A.
ACCE- American College of Clinical Engineering U.S.A.
NFPA-National Fire Protection Association U.S.A.
OSHA-Occupational Safety Health Association
JCI-Joint Commission International
JCAHO-Joint Commission in Accreditation of Healthcare Organization
BMET-Biomedical Equipment Technician
CBET-Certified Biomedical Equipment Technician
CBET-RES Certified Biomedical Equipment Technician Radiological Equipment Specialist
CBET-LES Certified Biomedical Equipment Technician Laboratory Equipment Specialist
ISO-International Standards Organization
IEC-International Electrotechnical Commission
VAC-Volts, Alternating Current
DCV-Volts, Direct Current
ESA-Electrical Safety Analyzer
ESU-Electrosurgical Unit
UMDNS-Universal Medical Device Nomenclature System
GMDNS-Global Medical Device Nomenclature System
ECRI- Emergency Care Research Institute
ASHE-American Society of Healthcare Engineering

Page | 32
UMDNS Nomenclature

Page | 33
Page | 34
Page | 35
Page | 36
Page | 37
Page | 38
Page | 39
Page | 40
Page | 41
Page | 42
Page | 43
Page | 44
Page | 45
Page | 46
Page | 47
Page | 48
Page | 49
Page | 50
Page | 51
Page | 52
Page | 53
Page | 54
Page | 55
Page | 56
Page | 57
Page | 58
Page | 59
Page | 60
Page | 61
Page | 62
Page | 63
Page | 64
Page | 65
Page | 66
Page | 67
Page | 68
Page | 69
Page | 70
Page | 71
Page | 72
Page | 73
Page | 74
Page | 75
Page | 76
Page | 77
Page | 78
Page | 79
Page | 80
Page | 81
Page | 82
Page | 83
Page | 84
Page | 85
Page | 86
Page | 87
Page | 88
Page | 89
Page | 90
Page | 91
Page | 92
Page | 93
Page | 94
Page | 95
Page | 96
Page | 97
Page | 98
Page | 99
Page | 100
Page | 101
Page | 102