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Core Medical Equipment




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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WHO/HSS/EHT/DIM/11.03


© World Health Organization 2011


All rights reserved. World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland


(tel.: +41 22 791 3264; fax: +41 22 791 4857). Requests for permission to reproduce or translate


WHO publications – whether for sale or for noncommercial distribution – should be addressed to


WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int).


The designations employed and the presentation of the material in this publication do not


imply the expression of any opinion whatsoever on the part of the World Health Organization


concerning the legal status of any country, territory, city or area or of its authorities, or concerning


the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border


lines for which there may not yet be full agreement.


The mention of specific companies or of certain manufacturers’ products does not imply that


they are endorsed or recommended by the World Health Organization in preference to others of


a similar nature that are not mentioned.


Errors and omissions excepted, the names of proprietary products are distinguished by initial


capital letters.


All reasonable precautions have been taken by the World Health Organization to verify the


information contained in this publication. However, the published material is being distributed


without warranty of any kind, either expressed or implied. The responsibility for the interpretation


and use of the material lies with the reader. In no event shall the World Health Organization be


liable for damages arising from its use.




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Analyzer, Laboratory, Hematology, Blood Grouping, Automated


Anesthesia Unit


Apnea Monitors


Aspirator


Auditory Function Screening Device, Newborn


Bilirubinometer


Blood Gas/pH/Chemistry Point of Care Analyzer


Blood pressure monitor


Bronchoscope


Cataract Extraction Units


Clinical Chemistry Analyzer


Colonoscope


Cryosurgical Unit


Cytometer


Defibrillator, External, Automated; Semiautomated


Defibrillator, External, Manual


Densitometer, Bone


Electrocardiograph, ECG


Electrosurgical Unit


Fetal Heart Detector, Ultrasonic


Fetal monitor


Glucose Analyzer


Hematology Point of Care Analyzer


Hemodialysis Unit


Immunoassay Analyzer


Incubator, Infant




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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n Laser, CO2


Laser, Ophthalmic


Mammography unit


Monitor, Bedside, Electroencephalography


Monitor, Central Station


Monitoring System, Physiologic


Monitor, Telemetric, Physiologic


Peritoneal Dialysis Unit


Pulmonary function analyzer


Radiographic, Fluoroscopic System


Radiotherapy Planning System


Radiotherapy Systems


Remote-afterloading brachytherapy system


Scanning System, CT


Scanning System, Magnetic Resonance Imaging, Full-Body


Scanning System, Ultrasonic


Transcutaneous Blood Gas Monitor


Ventilator, Intensive Care


Ventilator, Intensive Care, Neonatal/Pediatric


Ventilator, Portable


Videoconferencing system, Telemedicine


Warming Unit, Radiant, Infant


Whole Blood Coagulation Analyzer




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Core medical equipment
“Core medical equipment” refers here to technologies that are commonly considered as important or


necessary for specific preventive, diagnostic, treatment or rehabilitation procedures carried out in most


health care facilities.


Today, there are more than 10,000 types of medical devices available. The selection of appropriate medical


equipment always depends on local, regional or national requirements; factors to consider include the type


of health facility where the devices are to be used, the health work force available and the burden of disease


experienced in the specific catchment area. It is therefore impossible to make a list of core medical equipment


which would be exhaustive and/or universally applicable.


With that being said, we have reproduced hereafter a set of core medical equipment fact sheets which have


been issued by the ECRI Institute and the GMDN Agency, with a view to raising stakeholders’ awareness


about their existence and their functionality.


Each fact sheet displays a type of medical equipment, the health problems addressed by the device, the


operation procedures, its typical size, weight and price range, and infrastructure requirements for effective


and safe use. Technologies are placed into context of existing nomenclature systems; they are not specific


to any brand, model or vendor. The equipment is classified under the following categories: therapeutic,


diagnostic, chronic disease and child health.


The WHO Department of Essential Health Technologies is planning to continuously update the list of core


medical equipment and make it publicly available on the WHO website for information purposes, subject to


the disclaimers here below.


WHO has not reviewed the safety, efficacy, quality, applicability, or cost acceptability of any of the technologies


referred to hereafter. Therefore, inclusion of the aforesaid fact sheets herein does not constitute a warranty of


the fitness of any technology or of any resulting product and any future development thereof, for a particular


purpose. Besides, the responsibility for the quality, safety and efficacy of each technology or each resulting


product remains with its developer, owner and/or manufacturer.


WHO will not be held to endorse nor to recommend any technology or any resulting product thereof, as such


or in preference to others of a similar nature.


WHO does not warrant or represent that the use of the technologies or the resulting products thereof is,


or will be, in accordance with the national laws and regulations of any country, including but not limited to


patent laws. WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss,


damage or other prejudice of any kind whatsoever that may arise as a result of, or in connection with, the


procurement, distribution and/or use of any technology referred to hereafter, or of any resulting product and


any future development thereof.


Developers, owners and/or manufacturers of the technologies or resulting products thereof shall not, in any


statement of an advertising, commercial and/or promotional nature, refer to the inclusion of their technologies


in this publication. In no case shall the latter use the WHO name and/or the emblem, or any abbreviation


thereof, in relation to their business or otherwise.


Disclaimer




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Blood grouping systems perform basic blood processing tests
that include ABO grouping and subgrouping, Rh and other
red cell phenotyping, and antibody detection. These tests
determine factors that can cause transfusion reactions such
as red cell hemolysis, anaphylaxis, and other immunologic and
nonimmunologic effects.


Product description
Floor-standing or benchtop device includes a rack or tray onto
which patient blood sample tubes are loaded; the samples are
mixed with reagents to determine blood type and the results are
displayed on a monitor; cabinets or compartments store reagent
vessels; a monitor, keyboard, mouse, and printer (or entire
computer) may be connected for programming, data entry, and
to view and print testing results.


Principles of operation
Blood tube containing ethylenediamine-tetraacetic acid (EDTA)
anticoagulant is loaded onto the analyzer, and the operator
usually centrifuges them to separate the RBCs from the plasma.
Automated analyzers typically resuspend the RBCs in saline and
load the diluted samples onto microplates to which reagents
(known antisera) have been added. Blood group identity occurs
when the known antiserum, containing antibodies, clumps
(agglutinates) RBCs that have a corresponding antigen. Bar-
code labels provides a means of sample tracking.


Operating steps
Technicians load tubes into the sample tray and keep reagents
fi lled; tests are programmed either via a touchscreen panel on
the instrument, a computer, or the required test information is
on the tube’s printed bar code.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital, blood bank, clinical
laboratory


Requirements: Line power, water supply,
benchtop or fl oor space, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 1,000 x 1,750 x
900


Approx. weight (kg): 50-500


Consumables: Reagents, blood tubes


Price range (USD): 115,000 - 225,000


Typical product life time (years): 5-7


Shelf life (consumables): EDTA: 1 year


Types and variations
Benchtop or fl oor-standing


Analyzer, Laboratory, Hematology, Blood Grouping, Automated
UMDNS GMDN
16817 Analyzers, Laboratory, Hematology, Blood Grouping,


Automated
56712 ABO/Rh(D) blood grouping analyser IVD,


automated


Other common names:
Blood type analyzer, ABO blood typing system, AB0 blood typing system;Blood Grouping System




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Anesthesia units dispense a mixture of gases and vapors and
vary the proportions to control a patient’s level of consciousness
and/or analgesia during surgical procedures.


Product description
An anesthesia system comprises of a gas delivery platform,
a data analysis and distribution system, and physiologic and
multigas monitors (optional in most units), which indicate levels
and variations of several physiologic variables and parameters
associated with cardiopulmonary function and/or gas and
agent concentrations in breathed-gas mixtures. Manufacturers
typically offer a minimum combination of monitors, alarms, and
other features that customers must purchase to meet standards
and ensure patient safety.


Principles of operation
Because O2 and N2O are used in large quantities, they are usually
drawn from the hospital’s central gas supplies. Vaporizers add a
controlled amount of anesthetic vapor to the gas mixture. An
automatic ventilator is generally used to mechanically deliver
breaths to the patient. The ventilator forces the anesthesia gas
mixture into the patient’s breathing circuit and lungs and, in a
circle breathing system, receives exhaled breath from the patient
as well as fresh gas. A scavenging system captures and exhausts
waste gases to minimize the exposure of the operating room
staff to harmful anesthetic agents. Scavenging systems remove
gas by a vacuum, a passive exhaust system, or both.


Operating steps
A mask is placed over the nose and mouth. The anesthesia
unit dispenses a mixture of gases and vapors and varies the
proportions to control a patient’s level of consciousness
and/or analgesia during surgical procedures. The patient is
anesthetized by inspiring a mixture of O2, the vapor of a volatile
liquid halogenated hydrocarbon anesthetic, and, if necessary,
N2O and other gases.


Reported problems
One of the greatest dangers of anesthesia is hypoxia, which
can result in brain damage or death, though the administration
of concentrated O2 (100%) may be toxic. Gas with excessive
CO2 concentration, an inadequate amount of anesthetic agent,
or dangerously high pressure may cause hypoventilation,
compromised cardiac output, pneumothorax, and asphyxiation.
Contamination of the anesthesia breathing circuit may lead to
nosocomial infections.


Use and maintenance
User(s): Anesthesiologist, nurse anesthetist,
medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide, some
manufacturers offer offsite training or remote
training


Environment of use
Settings of use: Hospital (surgery),
ambulatory surgery centers


Requirements: Uninterruptible power source,
O2 fail-safe and hypoxic mixture fail-safe
systems, gas cylinder yokes for O2 if central
supplies fail, internal battery (for units with
automatic ventilators) capable of powering
the unit for at least 30 minutes


Product specifi cations
Approx. dimensions (mm): 1,500 x 700 x 700


Approx. weight (kg): 130


Consumables: Anesthetic agents, tubing,
masks


Price range (USD): 5,000 - 100,000


Typical product life time (years): 8-10


Shelf life (consumables): Variable


Types and variations
Cart mounted, ceiling mounted, wall mounted,
mobile


Anesthesia Unit
UMDNS GMDN
10134 Anesthesia Units 47769 Anaesthesia unit, mobile


Other common names:
Anesthesia machines; Anaesthesia apparatus; Gas-machine, anesthesia




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Apnea monitors detect the cessation of breathing (apnea) in
infants and adults who are at risk of respiratory failure and
alert the parent or attendant to the condition. Some prolonged
respiratory pauses result in low oxygen concentration levels in
the body, which can lead to irreversible brain damage and, if
prolonged, death.


Product description
The components of apnea monitors depend specifi cally on
the type. However, in general they are composed of a set of
sensors which obtain the information of different physiological
parameters. This information is passed to a micro computer
system, which analyses the sensors’ information and determines
if apnea is occurring.


Principles of operation
Monitors that use impedance pneumography detect small
changes in electrical impedance as air enters and leaves the
lungs and as the blood volume changes in the thoracic cavity.
Mattress-type motion sensors typically monitor changes in the
capacitance or resistance of a mattress transducer. Pneumatic
abdominal sensors also detect breaths as changes in pressure.
More direct methods of respiration detection monitor the airfl ow
into and out of the lungs; these include thermistors, proximal
airway pressure sensors, and carbon dioxide (CO2) sensors.


Operating steps
The apnea monitor is attached to the patient using appropriate
sensor for the measurement technique (e.g., mattress motion
sensor, pneumatic abdominal sensors, thermistors, proximal
airway pressure sensors, carbon dioxide (CO2) sensors, cannula).
Once connected, as the patient breathes, the unit monitors
different body parameters. If an alarm sounds, the operator
must attend the patient immediately.


Reported problems
Apnea monitors may fail to alarm during an episode because
they sense artifact (artifacts include vibrations, heart activity,
patient movement). Electromagnetic emissions from electronic
devices (other electronics or equipment) can also cause
interference, possibly leading to false breath and heartbeat
detection. Impedance pneumographs are more subject to
cardiovascular artifact. Misinterpreting impedance changes
because of heartbeats perceived as breaths frequent when
instrument sensitivity is not adjusted.


Use and maintenance
User(s): Nurse, medical staff, home care
providers


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, home, ambulatory
care center, nursery


Requirements: Uninterruptible power source,
battery backup


Product specifi cations
Approx. dimensions (mm): 150 x 120 x 120


Approx. weight (kg): 0.75


Consumables: Batteries, cables, electrodes/
sensors


Price range (USD): 200 - 5,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Stand-alone, modular


Apnea Monitors
UMDNS GMDN
12575 Monitors, Bedside, Respiration, Apnea 35194 Respiratory apnoea monitoring system


Other common names:
Cardiorespiratory monitors; Monitor, recording, apnoea




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Most surgical procedures require suctioning to remove blood,
gas, tissue, or other foreign materials and irrigating fl uids that
accumulate in the operative fi eld and obstruct the surgeon’s
view. Portable or mobile aspirators can be used if there is no
central vacuum system or if suctioning is required in areas that
do not have vacuum inlets.


Product description
Surgical aspirators consist of a line-powered vacuum pump, a
vacuum regulator and gauge, a collection canister, and an optional
bacterial fi lter. Plastic tubing connects these components,
completing an open-ended system that continuously draws
tissue debris and fl uid from the surgical fi eld to the collection
canister. The gauge allows the user to set a safe limit for
suctioning, to assess the performance of the vacuum pump,
and to detect leaks or blockages. Units are either portable or
mounted on a stand or cart for mobility.


Principles of operation
Various pump confi gurations include rotary-vane, diaphragm,
and piston. Each mechanism alternately increases and decreases
the vacuum and/or chamber volume, creating suction. Air is
drawn from the external tubing into the chamber, drawing
aspirate into a collection canister. Most surgical aspirators
have an overfl ow-protection assembly that prevents fl uid from
overfl owing into the pump and valves.


Operating steps
Operator powers on unit and selects appropriate suction level
and inserts suction tip into patient cavity. Collection canisters
should be monitored and emptied if they come close to capacity.


Reported problems
Suction regulators must be accurate; suction levels that are too
high can cause tissue damage. Some models operate at high
noise levels that can eclipse the volume of alarms for other
devices. A pump containing aspirated fl uid can be a source
of contamination. Changing or cleaning the suction tip during
surgeries or other use can help reduce infection risk. Operators
should follow universal precautions, including wearing gloves,
face shields or masks, and gowns.


Use and maintenance
User(s): Surgeons, assisting surgeons, nurses,
respiratory therapists, other medical staff


Maintenance: Biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: OR, patient bedside, home,
long-term care, ER


Requirements: Line power, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 300 x 400 x 800


Approx. weight (kg): 5-25


Consumables: Tubing, collection canisters,
liners, batteries


Price range (USD): 160 - 5,000


Typical product life time (years): 8-10


Shelf life (consumables): Rubber tubing: 10 yrs


Types and variations
Portable (sometimes considered a separate
category of emergency aspirators) or on
a cart; disposable or reusable canisters;
waterproof designs. The three types of pumps
used in surgical aspirators are rotary vane,
diaphragm, and cylinder piston


Aspirator
UMDNS GMDN
10217 Aspirators, Surgical 10217 Surgical suction system


Other common names:
Suction unit, suction pump, evacuator, vacuum pump




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices that allow hearing impairments to be detected quickly
so that any speech and language defi ciencies can be addressed
with early intervention programs. If hearing impairments are
not detected early in life, social, emotional, and intellectual
development (e.g., speech and language acquisition, academics)
can be affected. Permanent childhood hearing loss is the most
common defect that can be diagnosed at birth.


Product description
Devices consisting of a main testing system with a display screen
and ear tips, earmuffs, or electrodes; the unit can be table- or
cart-mounted.


Principles of operation
Once the ear probe(s) or electrodes are in place, infant
screening tests are performed using either auditory brainstem
response (ABR) or otoacoustic emissions (OAEs). ABR, an
electrophysiologic assessment, is used to measure the auditory
system’s response to sound. A soft click (usually 35 to 50 decibels
[dB]) is presented to the ear(s) via earphones or probes. OAE
is a screening method based on measuring the integrity of the
outer hair cells in the cochlea (inner ear). A soft click (usually 25
dB) is presented, and a small microphone measures the acoustic
response that is returned from the baby’s ear via a probe in the
ear canal.


Operating steps
For OAE screening the screener places a miniature earphone
and microphone in the infant’s ear. Sounds are played, and a
response is measured. If the infant hears normally, an echo is
refl ected into the ear canal and is measured by the microphone.
If there is no hearing loss, no echo can be measured. For ABR
testing, sounds are played into an infant’s ears. Electrodes are
placed on the baby’s head to detect responses. This measures
how the hearing nerve responds to sounds and can identify
infants with a hearing loss.


Reported problems
Users may experience diffi culty inserting probes into the ear
canal. Improper probe fi tting can increase the referral rate.
Proper insertion technique is easily learned, but the operator
usually needs some instruction. Some units have alarms for
improper probe placement. Proper earphone placement and
electrode impedances during setup and continuous monitoring
during testing are important. Obstruction in earphones (tips or
muffs) or myogenic interferences should be monitored during
automatic checks.


Use and maintenance
User(s): Audiologist; medical staff


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 195 x 70 x 30


Approx. weight (kg): 0.25


Consumables: NA


Price range (USD): 2,995 - 22,000


Typical product life time (years): 7


Shelf life (consumables): NA


Types and variations
Units may be table- or cart-mounted.


Auditory Function Screening Device, Newborn
UMDNS GMDN
20167 Auditory Function Screening Devices, Newborn 58019 Otoacoustic emission system, battery-powered


Other common names:
Automated Hearing Screening Devices; Newborn Auditory Function Screening Devices; Newborn Hearing Screening
Devices; Universal Newborn Hearing Screening Systems




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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In healthy full-term neonates, bilirubin can rise to peak levels of
5 to 13 mg/dL between the second and fi fth days of life before
decreasing to normal levels between the fi fth and seventh days.
This produces jaundice, a yellowish discoloration of the skin, eyes,
and mucous membranes. Monitoring bilirubin concentration is
also important in children and in adults where elevated levels
may indicate a pre-hepatic, hepatic, or post-hepatic metabolic
disorder.


Product description
These devices come in a variety of physical confi gurations. They
may be relatively small, single-purpose hand-held instruments
that are simple to operate and are designed to measure the
concentration of bilirubin in the blood. They are often located in
neonatal intensive care units for rapid on-site bilirubin analysis,
which is essential for determining a proper treatment method.
Bilirubinometers may also be confi gured as larger benchtop
analyzers or stand-alone units.


Principles of operation
Bilirubin concentrations are determined either by whole
blood or serum analysis using spectrophotometric methods
or by skin-refl ectance measurements. The three methods of
spectrophotometric analysis are the direct spectrophotometric
method, the Malloy-Evelyn method, and the Jendrassik-Grof
method.


Operating steps
Blood samples are required for spectrophotometric analysis.
The analysis technique depends on both the type or types of
bilirubin being measured and the age of the patient (neonate
versus child or adult). Cutaneous bilirubinometers do not require
a blood sample. A light-emitting sensor is placed on the infant’s
skin (optimally on the forehead or sternum). The refl ected light
is split into two beams by a dichroic mirror, and wavelengths of
455 nm and 575 nm are measured by optical detectors.


Reported problems
Rapid changes in hydration (body water content) during
therapy can cause fl uctuations in blood bilirubin concentrations,
making assay results uncertain. Photo-oxidation (light-induced
breakdown) of bilirubin occurs if samples are exposed to light
for more than a few hours. Therefore, blood samples should be
protected from exposure to light.


Use and maintenance
User(s): Operator, medical staff


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 110 x 150 x 200


Approx. weight (kg): 3.4


Consumables: NA


Price range (USD): 3,100 - 7,000


Typical product life time (years): 6 to 8


Shelf life (consumables): NA


Types and variations
Benchtop; stand-alone; handheld


Bilirubinometer
UMDNS GMDN
15109
16166


Bilirubinometers
Bilirubinometers, Cutaneous


47988
16166


Bilirubinometer
Cutaneous bilirubinometer


Other common names:
Analyzers, Bilirubin; Bilirubin Analyzers; Jaundice Meters; Indirect Bilirubinometers




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© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Analyzers used to measure blood gas, pH, electrolytes,
and some metabolites in whole blood specimens. They can
measure pH, partial pressure of carbon dioxide and oxygen,
and concentrations of many ions (sodium, potassium, chloride,
bicarbonate) and metabolites (calcium, magnesium, glucose,
lactate). They are also used to determine abnormal metabolite
and/or electrolyte levels in blood and the patient’s acid-base
balance and levels of oxygen/carbon dioxide exchange.


Product description
Handheld device or benchtop device, sometimes placed on a
cart, with a display (usually LCD), a keypad to enter information,
and a slot to insert a test strip or sample tube. Some models
may have alarms, memory functions, touchpens, USB ports to
transfer data to a computer, and/or a small storage compartment
for reagents.


Principles of operation
Blood gas/pH analyzers use electrodes to determine pH, partial
pressure of carbon dioxide, and partial pressure of oxygen in
the blood. Chemistry analyzers use a dry reagent pad system
in which a fi lter pad impregnated with all reagents required for
a particular reaction is placed on a thin plastic strip. Electrolyte
analyzers use ion-selective electrode (ISE) methodology in
which measurements of the ion activity in the solution are made
potentiometrically using an external reference electrode and an
ISE containing an internal reference electrode.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,
or on test strips, and loaded into the analyzer. The operator may
select the tests being performed on the sample using a keypad
or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital, patient bedside,
physician offi ce, clinical laboratory, home


Requirements: Battery-operated handheld
devices do not have special settings
requirements; benchtop units require line
power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 400


Approx. weight (kg): 1-5 for handheld units;
15-25 for benchtop units


Consumables: Reagent cartridges or test
strips, batteries


Price range (USD): 150 - 165,000


Typical product life time (years): 4-6


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Handheld, portable, benchtop


Blood Gas/pH/Chemistry Point of Care Analyzer
UMDNS GMDN
18853 Analyzers, Point-of-Care, Whole Blood, Gas/pH/


Electrolyte/Metabolite
56661 Blood gas analyser IVD, automated


Other common names:
POC Analyzer, blood gas analyzer




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Health problem addressed
NIBP is an essential indicator of physiologic condition. As one of
the most frequently used diagnostic tests, it indicates changes
in blood volume, the pumping effi ciency of the heart, and the
resistance of the peripheral vasculature. Vital signs monitors are
used to measure basic physiologic parameters so that clinicians
can be informed of changes in a patient’s condition. Depending
on their confi guration, these units can measure and display
numerical data for NIBP, oxygen saturation, and temperature.


Product description
Automatic electronic sphygmomanometers noninvasively
measure and display a patient’s arterial blood pressure. The main
unit includes controls and a display; it also includes appropriate
attached cuffs, probes, and sensors that make possible sequential
and/or simultaneous measurements of the parameters. Some of
the NIBP monitors can be used as vital sign monitors with the
real-time measuring and display of two or more of the vital signs.
These monitors typically consist of portable or mobile electronic
units. The monitor may be connected to the line and/or powered
by internal batteries. Many devices may also perform continuous
monitoring during transportation or at the bedside. Vital signs
physiologic monitors are intended mainly for periodic automated
measuring of the parameters of one or more patients.


Principles of operation
Automatic electronic sphygmomanometers (NIBP monitors)
measure by the use of sound and detection of blood sound
turbulence (Korotkoff sounds). A microphone positioned against an
artery compressed by the device cuff detects the Korotkoff sounds,
enabling the unit to directly determine systolic and diastolic values
blood pressure values. NIBP is usually measured using cuffs and
either auscultatory or oscillometric techniques. The measurement
of temperature is typically accomplished using an intraoral sensor,
and SpO2 is determined using pulse oximetry sensors. These
monitors typically consist of portable or mobile electronic units
that facilitate movement from one location to other; the monitor
may be connected to the line and/or powered by internal batteries.


Operating steps
The cuffs, probes, and sensors are attached to the patient, and
then the monitor will begin taking intermittent or continuous
measurements as selected by the clinician. The devices may
remain at a patient’s bedside or can be transported by a caregiver
for vital signs spot checking throughout a care area. Alarms (e.g.,
for high blood pressure or low oxygen saturation) can typically
be set by caregivers and can be manually temporarily silenced.


Reported problems
Problems associated with monitors are often user-related.
Poor cuff placement or sensor preparation and attachment
are most commonly reported. Cables and lead wires should
be periodically inspected for breaks and cracks. Automatic


electronic sphygmomanometry and pulse
oximeters may have the inability to effectively
monitor patients with certain conditions (e.g.,
tremors, convulsions, abnormal heart rhythms,
low blood pressure)


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital (all areas),
ambulatory surgery centers


Requirements: Battery, uninterruptible power
source, appropriate cuffs/sensors


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 3


Consumables: Batteries, cables, sensors/
electrodes, cuffs


Price range (USD): 580 - 4,500


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Roll stand, portable, pole or bed mounts


Blood pressure monitor
UMDNS GMDN
18325
18326
25209


Sphygmomanometers, Electronic, Automatic,
Auscultatory
Sphygmomanometers, Electronic, Automatic,
Oscillometric
Monitors, Physiologic, Vital Signs


16173 Automatic-infl ation electronic
sphygmomanometer, non-portable


Other common names:
Vital signs monitoring units; noninvasive blood pressure (NIBP) monitors; auscultatory sphygmomanometers;
oscillometric sphygmomanometers; oscillotonometers, spot check monitors; spot checking; Recorder,
sphygmomanometer, automatic




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


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Health problem addressed
Devices that are introduced at the nose or mouth to observe
distal branches of the bronchi. Through working channels in the
bronchoscope, the physician can sample lung tissue (e.g., when
pulmonary malignancies are suspected), instill radiographic
media for bronchographic studies, perform laser therapy, remove
foreign objects, suction sputum for microbiological culturing,
insert catheters, and perform diffi cult intubations.


Product description
These devices consist of a proximal housing, a fl exible insertion
tube ranging from 0.5 to 7.0 mm in diameter, and an “umbilical
cord” connecting the light source and the proximal housing.
The proximal housing, which is designed to be held in one hand,
typically includes the eyepiece (fi beroptic models only), controls
for distal tip (bending section) angulation and suction, and the
working channel port.


Principles of operation
The bronchoscope (either fl exible or rigid) is inserted into
the airways, usually through the mouth or nose. Sometimes
the bronchoscope is inserted via a tracheostomy. Rigid
bronchoscopes are used for the removal of foreign bodies
while fl exible video bronchoscopes are intended to provide
images of a patient’s airways and lungs. Images provided by
the bronchoscope can be focused by adjusting the ocular on
the scope’s proximal housing. A video bronchoscope uses a
charge-coupled device (CCD) located at the distal tip of the
scope to sense and transmit images, replacing the image guide
and eyepiece. These images can then be recorded, printed,
stored on digital media, or transmitted to another location for
simultaneous viewing.


Operating steps
If a rigid bronchoscope is used, the patient will require anesthesia
before insertion into the airway via either the mouth or nose. For
procedures using fl exible bronchoscopes, the patient’s throat
will be numbed and the tube is then inserted into the airway via
either the mouth or nose. Video bronchoscopes are also inserted
via the mouth or nose, but have the benefi t of permitting the
physician to see the patient’s airways on an external monitor,
rather than through an eyepiece.


Reported problems
Despite the remote location of the light source, some of the
heat produced by the lamp is transmitted to the tip of the
bronchoscope. Bronchospasms and abnormal heartbeats may
occur in patients with respiratory or cardiac disorders. Bronchial
perforations can occur if biopsy brushes or other instruments
are forced out of the bronchoscope’s distal end and meet
resistance. Other complications may include loss of biopsy
brushes, or breakage of biopsy forceps.


Use and maintenance
User(s): Dedicated operator


Maintenance: Medical staff; technician;
biomedical or clinical engineer; central
sterile processing technician for cleaning and
disinfecting


Training: Supervised training with experienced
users


Environment of use
Settings of use: Endoscopy suite; operating
room; intensive care unit (rarely)


Requirements: Stable power source; access
to anesthesia and patient monitoring; oxygen
and suction should be available; access to
PACS or x-ray viewbox; bronchoscopy suite
should have direct external ventilation, HEPA
fi ltration


Product specifi cations
Approx. dimensions (mm): 600


Approx. weight (kg): 2.3


Consumables: NA


Price range (USD): 3,560 - 53,120


Typical product life time (years): 4 to 5


Shelf life (consumables): NA


Types and variations
Flexible; fl exible video; rigid


Bronchoscope
UMDNS GMDN
15073
17662
15074


Bronchoscopes, Flexible
Bronchoscopes, Flexible, Video
Bronchoscopes, Rigid


35461
44921
17662
15074


Flexible fi breoptic bronchoscope
Flexible ultrasonic bronchoscope
Flexible video bronchoscope
Rigid bronchoscope


Other common names:
Bronchial Endoscopes; Video Bronchoscopes




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© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices intended to break up and remove cataractous lenses of
the eye. Cataracts inhibit the transmission of light to the retina
and cause a painless blurring of vision. Cataracts are caused
by changes in the chemical composition of the lens associated
with many factors including age, environment, drugs, systemic
diseases, traumatic eye injuries, certain diseases of the eye, and
genetic or birth defects.


Product description
These units consist of a hollow probe (i.e., a phaco probe) that
includes an irrigation sleeve, an oscillating tip that converts
electric energy into ultrasonic waves, and a channel for
aspiration of lens fragments; the units also include a vacuum
pump and controls for the output levels, irrigation rate, and
mode of operation. CSUs (cryosurgical units) apply a refrigerant
(cryogen) to withdraw heat from target tissue either through
direct application or indirectly through contact with a cryogen-
cooled probe.


Principles of operation
These devices are intended to remove cataractous lenses by the
insertion of a probe that cuts and emulsifi es the lenses using
ultrasonic waves (phacoemulsifi cation).


Operating steps
An incision is made to gain access to the eye’s anterior
chamber. A viscoelastic material is then infused to deepen the
anterior chamber. After removing the anterior lens capsule
and hydrodissecting the lens to separate it from the cortex
and capsule, the surgeon inserts a phacoemulsifi cation probe
tip. The probe tip oscillates rapidly creating ultrasonic waves
that cut tissue. The cataractous lens is emulsifi ed and the lens
fragments are then aspirated from the eye through the hollow
tip of the phacoemulsifi er.


Reported problems
Thermal lesions to the sclera and cornea due to insuffi cient
irrigation and aspiration fl ow; metal fragments being left
in patients’ eyes following phacoemulsifi cation and of
phacoemulsifi cation units failing to vacuum; torn posterior
capsule due to high vacuum; postoperative endophthalmitis
resulting from bacterial contamination; surgically induced
astigmatism; corneal burns.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals; supervised training with experienced
surgeons


Environment of use
Settings of use: Operating room


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 245 x 220 x 154


Approx. weight (kg): 5.6


Consumables: NA


Price range (USD): 13,000 - 105,000


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Modular (in console); stand-alone; portable


Cataract Extraction Units
UMDNS GMDN
17596
11068


Phacoemulsifi cation Units, Cataract Extraction
Cryosurgical Units, Ophthalmic


45071
11068


Phacoemulsifi cation system generator
Ophthalmic cryosurgical system, mechanical


Other common names:
Phacoemulsifi cation Units; Phacoemulsifi ers; Cryoextractors; Cryosurgical Systems; Erysiphakes; Extractors, Cataract;
Fragmatomes; Cryophthalmic unit; unit, cryotherapy, ophthalmic




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Perform tests on whole blood, serum, plasma, or urine samples
to determine concentrations of analytes (e.g., cholesterol,
electrolytes, glucose, calcium), to provide certain hematology
values (e.g., hemoglobin concentrations, prothrombin times),
and to assay certain therapeutic drugs (e.g., theophylline),
which helps diagnose and treat numerous diseases, including
diabetes, cancer, HIV, STD, hepatitis, kidney conditions, fertility,
and thyroid problems.


Product description
Chemistry analyzers can be benchtop devices or placed on a cart;
other systems require fl oor space. They are used to determine
the concentration of certain metabolites, electrolytes, proteins,
and/or drugs in samples of serum, plasma, urine, cerebrospinal
fl uid, and/or other body fl uids. Samples are inserted in a slot or
loaded onto a tray, and tests are programmed via a keypad or
bar-code scanner. Reagents may be stored within the analyzer,
and it may require a water supply to wash internal parts. Results
are displayed on a screen, and typically there are ports to
connect to a printer and/or computer.


Principles of operation
After the tray is loaded with samples, a pipette aspirates a
precisely measured aliquot of sample and discharges it into the
reaction vessel; a measured volume of diluent rinses the pipette.
Reagents are dispensed into the reaction vessel. After the
solution is mixed (and incubated, if necessary), it is either passed
through a colorimeter, which measures its absorbance while it is
still in its reaction vessel, or aspirated into a fl ow cell, where
its absorbance is measured by a fl ow-through colorimeter. The
analyzer then calculates the analyte’s chemical concentrations.


Operating steps
The operator loads sample tubes into the analyzer; reagents may
need to be loaded or may already be stored in the instrument. A
bar-code scanner will read the test orders off the label on each
test tube, or the operator may have to program the desired tests.
After the required test(s) are run, the results can be displayed
on-screen, printed out, stored in the analyzer’s internal memory,
and/or transferred to a computer.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or fl oor
space, water supply, line power, biohazard
disposal


Product specifi cations
Approx. dimensions (mm): 500 x 700 x 1,000


Approx. weight (kg): 30-700


Consumables: Reagents, sample cells


Price range (USD): 10,000 - 465,000


Typical product life time (years): 5-7


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Some chemistry analyzers can be interfaced
to an automated immunoassay analyzer to
decrease operator intervention and possibly
improve workfl ow.


Clinical Chemistry Analyzer
UMDNS GMDN
16298 Analyzers, Laboratory, Clinical Chemistry,


Automated
35918
56676


Laboratory urine analyser IVD, automated
Laboratory multichannel clinical chemistry
analyser IVD, automated


Other common names:
Biochemistry analyzer




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Colonoscopes are used for the removal of foreign bodies, excision
of tumors or colorectal polyps (polypectomy), and control of
hemorrhage. Routine colonoscopy is important in diagnosing
intestinal cancer, the second leading cause of cancer deaths in
the United States. These endoscopic procedures reduce the need
for invasive surgical diagnostic and therapeutic procedures.


Product description
These devices consist of a proximal housing, a fl exible insertion
tube, and an “umbilical cord” connecting the light source and the
proximal housing. The proximal housing, which is designed to
be held in one hand, typically includes the eyepiece (fi beroptic
models only), controls for distal tip (bending section) angulation
and suction, and the working channel port. Colonoscopes have
several hollow channels for suction, water and air delivery, and
insertion of accessory instruments and cannulae. The distal tip
of video colonoscopes includes a charge-coupled device (CCD)
that serves as a small camera and electronically transmits the
image from the CCD to an external video-processing unit.


Principles of operation
Video colonoscope insertion tubes contains a fi beroptic light
bundle, which transmits light from the light source to the tip of
the endoscope. Each fi beroptic bundle consists of thousands
of individual glass fi bers coated with glass causing internal
refl ections that allow light transmission through the fi ber even
when it is fl exed. The light is used to illuminate the fi eld of view
in the patient’s colon. Video images are detected by the CCD
and are then transmitted to the video processor and then display
monitors or recording devices.


Operating steps
The patient typically lies on his or her side on a procedure table.
Patients typically will require anesthesia or conscious sedation
before insertion of the colonoscope. The colonoscope is inserted
into the colon via the rectum by a gastroenterologist. Video
images are typically viewed throughout the procedure on a video
monitor. These images can then be recorded, printed, stored on
digital media, or transmitted to another location for simultaneous
viewing. The gastroenterologist manipulates the direction of the
device using controls on the colonoscope control housing.


Reported problems
Although rare, trauma to the colon and adjacent organs during
colonoscopy can result in complications such as bleeding, peritonitis,
and appendicitis. ECRI Institute has received reports of diffi culty
in inserting forceps through the instrument channel of contorted
colonoscopes, causing delays in procedures. Problems have
occurred related to blockage of the air channel from inadequately
rinsed disinfectant or retrograde fl ow of protein material into the
channel during a procedure. Also, patient infection is a common
mainly from improper cleaning and disinfection procedures.


Use and maintenance
User(s): Gastroenterologist


Maintenance: Medical staff; technician;
biomedical or clinical engineer; central
sterile processing technician for cleaning and
disinfecting


Training: Supervised training with experienced
users


Environment of use
Settings of use: Gastroenterology lab or suite,
operating room


Requirements: Stable power source; access
to anesthesia and patient monitoring; oxygen
and suction should be available; endoscopy
suite should have direct external ventilation,
HEPA fi ltration


Product specifi cations
Approx. dimensions (mm): 1,700


Approx. weight (kg): 5


Consumables: NA


Price range (USD): 25,000 - 41,000


Typical product life time (years): 4 - 5


Shelf life (consumables): NA


Types and variations
Video; fi beroptic


Colonoscope
UMDNS GMDN
10950 Colonoscopes 36117 Flexible video colonoscope


Other common names:
Endoscopes; video endoscopes; Video colonoscope, fl exible; Video colonoscope




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These devices provide an accepted treatment modality within
the fi elds of dermatology, oral surgery, gynecology, urology,
otolaryngology, proctology, and ophthalmology. They can be
used to treat malignant and benign tumors, acne, warts, and
hemorrhoids.


Product description
These devices are available as consoles or as stand-alone or
handheld units. Consoles are freestanding units that typically
contain cryogen gas cylinders, pressure regulators, indicators,
and operating controls. They are usually battery powered and
can be equipped with a probe-tip fi beroptic light source for
transillumination of tissue. Stand-alone units consist of a tank, a
pressure regulator, and a probe attached by tubing to the tank.
Handheld units are lightweight, portable CSUs that typically
use liquid nitrogen as the cryogen and are either reusable or
disposable (with individual gas cartridges).


Principles of operation
CSUs apply a refrigerant (cryogen) to withdraw heat from target
tissue either through direct application or indirectly through
contact with a cryogen-cooled probe. There are two basic types
of CSUs: those that use liquid nitrogen and those that use nitrous
oxide (N2O), carbon dioxide (CO2), or other compressed gases.
All CSUs employ either a closed or an open system. In a closed-
system CSU, the cryogen fl ows through an insulated shaft in the
hollow probe, cools the tip, and is exhausted back through the
probe. Open-system CSUs apply cryogen directly to the target
tissue. CSUs using N2O or CO2 are not usually suitable for use
as open systems because cryogen “snow” would build up on
the target tissue and insulate the lesion from the cryogen spray.
Liquid nitrogen CSUs can be either open or closed.


Operating steps
A surgeon will use a cryosurgical unit to introduce a refrigerant to
target tissue (e.g., wart, tumor) either through direct application
(dabbing or spraying on) or through a cryogen-cooled probe
(e.g., gun-type or pencil-shaped with either a curved or straight
tip). Cryosurgically treated tissue is usually left in situ and
allowed to become necrotic and slough off.


Reported problems
Few device-related problems have occurred with the use of
CSUs. Of continued concern is the mechanical integrity of the
units, especially the probe tips, because they are exposed to
temperature and pressure extremes. Also potential damage to
tissue outside of the treatment zone is a concern.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals; supervised training with experienced
surgeons


Environment of use
Settings of use: Operating room


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 690x360x660


Approx. weight (kg): 72


Consumables: Liquid nitrogen or other
compressed gases


Price range (USD): 535-95000


Typical product life time (years): 10


Shelf life (consumables): Variable


Types and variations
Console; stand-alone; handheld unit


Cryosurgical Unit
UMDNS GMDN
18051
11067


Cryosurgical Units
Cryosurgical Units, General-Purpose


11067 Cryosurgical system, mechanical


Other common names:
Cryoextractors; Cryoprobes; Cryostats; Cryo Units; CSU; Probes, Cryosurgical




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Used to diagnose and/or prognose leukemia, lymphoma,
immunodefi ciency disorders such as HIV infection, autoimmune
disease, and fetal abnormalities, and to evaluate the success of
transplantation procedures. Also used in cancer diagnosis and
research to evaluate drug resistance, detect tumor cell DNA
aneuploidy, immunophenotyping, and analyzing tumor cell
proliferation. Can be adapted to provide a rapid, sensitive, and
cost-effective way to detect, characterize, and identify bacteria.


Product description
Automated cytometers in which cells are dispersed in fl uid
suspension and fl ow one at a time through a narrow beam of
light, typically from a laser. Each cell generates optical signals
that are measured and analyzed. These cytometers include
a cell transportation system, a laser for cell illumination,
photodetectors for signal detection, and a computer-based
management system.


Principles of operation
Specifi c dyes and fl uorochromes are used to mark structures in
or on the cells. These dyes bind to specifi c cellular components,
such as DNA, cellular enzymes, membrane surface markers,
or other antigens. Cells are suspended in a liquid stream and
transported in a single-cell path to the analysis chamber.
They are illuminated by a beam of high-intensity light. When
exposed to light of a particular wavelength, the fl uorochromes
will fl uoresce, emitting light of a longer wavelength than the
incident light they absorb. A detection system analyzes each
cell at a rate of up to 10,000 cells/second.


Operating steps
Sample cells must be treated with reagents and are loaded
into the instrument. The operator may have to program the
desired wavelength and parameters measured using a computer
connected to the instrument.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or fl oor
space, line power


Product specifi cations
Approx. dimensions (mm): 600 x 450 x 500


Approx. weight (kg): 50-100


Consumables: Reagents, sample cells


Price range (USD): 27,000 - 250,500


Typical product life time (years): 5-7


Shelf life (consumables): Fluorescent dyes: 1
year


Types and variations
Cell-sorting capabilities can separate and
analyze specifi c cell types within the sample;
model may have multiple lasers or an
autoloader.


Cytometer
UMDNS GMDN
16867
16503


Cytometers, Automated, FlowCytometers,
Automated, Flow, Sorting


57839 Flow cytometry analyser IVD, automated


Other common names:
Flow cytometer, reticulocyte analyzer, cell sorter




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Health problem addressed
Fully automated external defi brillators (AEDs) deliver a high-
amplitude current impulse to the heart in order to restore normal
rhythm and contractile function in patients who are experiencing
ventricular fi brillation (VF) or ventricular tachycardia (VT) that
is not accompanied by a palpable pulse.


Product description
AEDs determine whether defi brillation is needed and
automatically charge and discharge to deliver a shock.
Semiautomated units analyze the ECG and charge in preparation
for shock delivery, but the operator activates the discharge.
AEDs typically include a memory module or PC data card,
disposable adhesive defi brillation electrodes, a display to give
status messages (patient and/or defi brillator), to display the
ECG waveform, or to prompt the user to initiate a shock.


Principles of operation
Automated defi brillators analyze the ECG rhythm to determine
if a defi brillation shock is needed; if it is, the defi brillator warns
the operator and automatically charges and discharges. Most
of these defi brillators use a single pair of disposable electrodes
to monitor the ECG and deliver the defi brillator discharge, but
some also incorporate ECG displays. The simple design and ease
of use of automated defi brillators requires very little training
and operational skill.


Operating steps
The operator attaches two adhesive defi brillator electrodes to
the cables or directly to the AED and applies the electrodes to
the patient. The AED will automatically analyze the rhythm to
determine whether defi brillation is necessary. In fully automatic
models, a shock is then automatically delivered when the rhythm
analysis determines it is necessary. In semiautomatic units the
user is prompted to deliver the shock.


Reported problems
Failure can be caused by defi brillator malfunction, poor
electrode application, inappropriate energy selection, a cardiac
physiologic state not conducive to defi brillation, or rechargeable
battery issues. First- and second-degree burns are especially
likely to occur during repeated defi brillation attempts (which
require successively higher energies) at the paddle or electrode
sites because a high current fl ow through a small area and/or
increased resistance (due to dried gel).


Types and variations
Portable, carrying case


Use and maintenance
User(s): Emergency medical services (EMS),
police offi cers, fi refi ghters, traditional
targeted responders (e.g., security guards,
fl ight attendants), nontraditional responders
(e.g., offi ce staff, family members), any
hospital staff trained in advance life support
(ALS) or basic life support (BLS).


Maintenance: Biomedical or clinical engineer/
technician, medical staff, out of hospital (e.g.,
airlines, shopping centers, emergency medical
servicers), manufacturer/servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, emergency transport,
emergency medical services, patient homes,
public building or other public settings


Requirements: Fully charged battery/good
battery care and maintenance procedures
in place, uninterruptible power source (to
power and recharge batteries), proper sized
shock pads or electrodes, maintenance
procedures to monitor shelf life of shock pads
or electrodes, as well as errors returned by
internal testing trials.


Product specifi cations
Approx. dimensions (mm): 100 x 250 x 200
Approx. weight (kg): 2.5
Consumables: Batteries, cables, electrodes/
pads (with gel)
Price range (USD): 1,300 - 2,300
Typical product life time (years): 10
Shelf life (consumables): 1-2 years for
disposable electrodes/pads


Defi brillator, External, Automated; Semiautomated
UMDNS GMDN
17116
18500


Defi brillators, External, Automated
Defi brillators, External, Semiautomated


48049


48048


Non-rechargeable professional semi-
automated external defi brillator
Rechargeable professional automated external
defi brillator


Other common names:
AEDs, automated external defi brillators, automatic external defi brillators, semiautomated defi brillators, and shock-
advisory defi brillators, PADs, automated public-access defi brillators




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Defi brillators are lifesaving devices that apply an electric shock
to establish a more normal cardiac rhythm in patients who are
experiencing ventricular fi brillation (VF) or another shockable
rhythm.


Product description
The defi brillator charges with a large capacitor. For external
defi brillation, paddles are needed to discharge on the patient’s
chest. Disposable defi brillation electrodes may be used as an
alternative. For internal defi brillation small concave paddles are
used. An ECG monitor included is used to verify a shockable
rhythm and the effectiveness of treatment. Many defi brillators
can be equipped with optional monitoring capabilities, such as
pulse oximetry, end-tidal carbon dioxide and NIBP.


Principles of operation
Defi brillators typically have three basic modes of operation:
external defi brillation, internal defi brillation, and synchronized
cardioversion. (Sync mode uses a defi brillator discharge to correct
certain arrhythmias, such as VT; a shock is delivered only when
the control circuits sense the next R wave. The delivery of energy
is synchronized with and shortly follows the peak of the R wave,
preventing discharge during the vulnerable period of ventricular
repolarization.) An audible/visible indicator inform when the
capacitor is charged and the device is ready. ECG monitoring
can be performed before, during, and after a discharge, usually
through ECG electrodes, although most external paddles and
disposable electrodes have ECG monitoring capability. Many
defi brillators are equipped with optional monitoring capabilities
(SpO2, ETCO2, temperature, NIBP).


Operating steps
Apply the paddles to the patient’s chest and discharges the
defi brillator. Synchronized cardioversion (sync mode) uses a
defi brillator discharge to correct certain arrhythmias, such as
VT. After verifying that the sync marker pulse appears reliably on
the R wave, the operator presses and holds the paddle discharge
buttons; a shock is delivered only when the control circuits sense
the next R wave. The delivery of energy is synchronized with and
shortly follows the peak of the R wave, preventing discharge
during the vulnerable period of ventricular repolarization, which
is represented by the T wave.


Reported problems
Failure can be caused by defi brillator malfunction, poor
electrode application, inappropriate energy selection, a cardiac
physiologic state not conducive to defi brillation, or rechargeable
battery issues. First- and second-degree burns are especially
likely to occur during repeated defi brillation attempts (which
require successively higher energies) at the paddle or electrode
sites because a high current fl ow through a small area and/or
increased resistance (due to dried gel).


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, emergency transport


Requirements: Fully charged battery/good
battery care and maintenance procedures
in place, uninterruptible power source (to
power and recharge batteries), proper sized
shock pads or electrodes, maintenance
procedures to monitor shelf life of shock pads
or electrodes, as well as errors returned by
internal testing trials.


Product specifi cations
Approx. dimensions (mm): 250 x 300 x 250


Approx. weight (kg): 5.5


Consumables: Batteries, cables, paddles/
electrodes, gel


Price range (USD): 1,000 - 25,000


Typical product life time (years): 6-7


Shelf life (consumables): 1-2 years for
disposable electrodes/pads


Types and variations
Cart mounted, carry case


Defi brillator, External, Manual
UMDNS GMDN
11134 Defi brillators, External, Manual 37806 Manual external defi brillator


Other common names:
Battery-powered defi brillators, cardioverters, defi brillator/monitor/ pacemakers, external biphasic defi brillators, external
monophasic defi brillators, and monitor/defi brillators; DC-defi brillator, high-energy (including paddles)




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
The primary purpose of these noninvasive measurements is to
detect quantitative decreases in bone mass related to metabolic
bone diseases such as osteoporosis and to assess effi cacy of
treatment.


Product description
Central DXA devices (dual-energy x-ray absorptiometers) use
a dual-energy x-ray source to assess bone mineral content in
the axial skeleton. These devices have a large, fl at table and
an “arm” suspended overhead. Ultrasonic bone densitometers
measure broadband ultrasonic attenuation (BUA) and speed of
sound (SOS), to provide a quantitative ultrasound index of the
appendicular skeleton. Peripheral devices measure bone density
in the wrist, heel or fi nger. The pDXA device is much smaller than
the Central DXA device. It is a portable box-like structure with a
space for the foot or forearm to be placed for imaging.


Principles of operation
DXA systems use one of two methods to create a dual-energy
spectrum from an x-ray source. One method involves alternating
pulses of low-and high-voltage power applied to the x-ray tube.
The attenuation values of the resulting low- and high-energy
x-rays are then measured separately. The other method applies a
constant potential to the x-ray source while using a K-edge fi lter
to separate the energy spectrum into two narrow energy bands.
An energy-discriminating detector with a dual-channel analyzer
counts the resultant photons. Ultrasonic bone densitometry
systems do not rely on a radiation source but instead use sound
waves to measure the integrity of the appendicular skeleton,
typically through the calcaneus or phalanges of the fi ngers.


Operating steps
This examination is usually done on an outpatient basis. In the
Central DXA examination, the patient lies on a padded table.
An x-ray generator is located below the patient and an imaging
device, or detector, is positioned above. To assess the spine,
the patient’s legs are supported on a padded box to fl atten the
pelvis and lower (lumbar) spine. To assess the hip, the patient’s
foot is placed in a brace that rotates the hip inward. In both
cases, the detector is slowly passed over the area, generating
images on a computer monitor.


Reported problems
No serious reports concerning the functioning of DXA scanners.


Use and maintenance
User(s): Bone densitometry technician


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospitals, medical offi ces
(central DXA); mobile health vans, drugstores
(pDXA)


Requirements: Stable power source; shielding
for treatment room and control room (central
bone densitometers)


Product specifi cations
Approx. dimensions (mm): 840 x 737 x 483


Approx. weight (kg): 181


Consumables: NA


Price range (USD): 9,180 - 199,000


Typical product life time (years): 12 to 15


Shelf life (consumables): NA


Types and variations
Central bone densitometers; peripheral bone
densitometers


Densitometer, Bone
UMDNS GMDN
17152
18382
17747


Densitometers, Bone
Densitometers, Bone, Ultrasonic
Densitometers, Bone, X-Ray, Dual-Energy
Absorptiometry


38314
37661


Bone absorptiometric radionuclide system
Bone absorptiometric x-ray system, dual-
energy


Other common names:
Absorptiometers, X-Ray, Dual-Energy; Central DXA Systems; DEXA Systems; Diagnostic Bone Absorptiometer;
Dual-Energy Densitometers; Dual-Energy X-Ray Absorptiometers; DXA Systems; Peripheral DXA Systems (pDXA);
Radionuclide Systems; Ultrasonometers; Absorptiometer, dual-photon; RI bone mineral analyser; Dual-energy x-ray
absorptiometry (DEXA) system




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Electrocardiographs detect the electrical signals associated
with cardiac activity and produce an ECG, a graphic record of
the voltage versus time. They are used to diagnose and assist in
treating some types of heart disease and arrhythmias, determine
a patient’s response to drug therapy, and reveal trends or
changes in heart function. Multichannel electrocardiographs
record signals from two or more leads simultaneously and
are frequently used in place of single-channel units. Some
electrocardiographs can perform automatic measurement and
interpretation of the ECG as a selectable or optional feature.


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


Principles of operation
Electrocardiographs record small voltages of about one millivolt
(mV) that appear on the skin as a result of cardiac activity. The
voltage differences between electrodes are measured; these
differences directly correspond to the heart’s electrical activity.
Each of the 12 standard leads presents a different perspective of the
heart’s electrical activity; producing ECG waveforms in which the P
waves, QRS complex, and T waves vary in amplitude and polarity.
Other lead confi gurations include those of the Frank system and
Cabrera leads. The Frank confi guration measures voltages from
electrodes applied to seven locations—the forehead or neck, the
center spine, the midsternum, the left and right midaxillary lines,
a position halfway between the midsternum and left midaxillary
electrodes, and the left leg.


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


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


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital (all areas), family
medicine practices and other medical offi ces


Requirements: Uninterruptible power source,
battery backup, appropriate electrodes


Product specifi cations
Approx. dimensions (mm): 120 x 400 x 350


Approx. weight (kg): 6


Consumables: Batteries, cables, electrodes


Price range (USD): 975 - 6,000


Typical product life time (years): 10


Shelf life (consumables): 1-2 years for
disposable electrodes/sensors


Types and variations
Portable, cart, desktop, tabletop


Electrocardiograph, ECG
UMDNS GMDN
16231
18330


18329
17687


11413


Electrocardiographs, Multichannel, Interpretive
Electrocardiographs, Multichannel, Interpretive,
Signal-Averaging
Electrocardiographs, Multichannel, Noninterpretive
Electrocardiographs, Multichannel, Noninterpretive,
Signal-Averaging
Electrocardiographs, Single-Channel


16231
17687


11413


Interpretive multichannel electrocardiograph
Signal-averaging multichannel
electrocardiograph
Single-channel electrocardiograph


Other common names:
Computer-assisted electrocardiographs; interpretive ECG machines; interpretive electrocardiographs; automated
electrocardiographs; EKG machines; Electrocardiograph multichannel;




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Devices intended for surgical cutting and for controlling
bleeding by causing coagulation (hemostasis) at the surgical
site. Electrosurgery is commonly used in dermatological,
gynecological, cardiac, plastic, ocular, spine, ENT, maxillofacial,
orthopedic, urological, neuro- and general surgical procedures
as well as certain dental procedures.


Product description
These systems include an electrosurgical generator (i.e., power
supply, waveform generator) and a handpiece including one or
several electrodes.


Principles of operation
In monopolar electrosurgery, tissue is cut and coagulated
by completion of an electrical circuit that includes a high-
frequency oscillator and amplifi ers within the ESU, the patient,
the connecting cables, and the electrodes. In most applications,
electric current from the ESU is conducted through the surgical
site with an active cable and electrode. The electrosurgical
current exits the patient through a dispersive electrode (usually
placed on the patient at a site remote from the surgical site)
and its associated cable connected to the neutral side of the
generator. In bipolar electrosurgery, two electrodes (generally,
the two tips of a pair of forceps or scissors) serve as the
equivalent of the active and return electrodes in the monopolar
mode.


Operating steps
Electrosurgical procedures may or may not be performed
with the patient under anesthesia. The patient is prepped and
electrodes are applied to the affected areas. Electrical current
is delivered to the affected area and the surrounding tissue is
heated to cause desiccation, vaporization, or charring to remove
diseased or damaged tissue.


Reported problems
There is a risk of surgical fi re when using oxygen while performing
electrosurgery. Partial or complete detachment of the electrode
pad from the patient is a common cause of patient burns. Burns
may also result from inadequate site preparation, defective
materials or construction, or incorrect placement of the return
electrode. The second most common type of electrosurgical
injury occurs when the active electrode is inadvertently
energized while the tip is in contact with nontarget tissue.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals; supervised training with experienced
surgeons


Environment of use
Settings of use: Hospital operating room


Requirements: Stable power source; smoke
evacuation


Product specifi cations
Approx. dimensions (mm): 777 x 360 x 505


Approx. weight (kg): 28


Consumables: Active and return electrodes


Price range (USD): 1,500 - 14,000


Typical product life time (years): 7 to 10


Shelf life (consumables): Single use or variable


Types and variations
Bipolar unit; monopolar unit; monopolar/
bipolar unit


Electrosurgical Unit
UMDNS GMDN
11490
18230
18229
18231


Electrosurgical Units
Electrosurgical Units, Bipolar
Electrosurgical Units, Monopolar
Electrosurgical Units, Monopolar/Bipolar


44776 General-purpose electrosurgical diathermy
system


Other common names:
Bovies; Coagulators, Electrosurgical; Diathermy Units, Surgical; Electrocautery Units; Electrosurgical Generators;
Endometrial Ablation Systems; ESUs; Hyfrecators; Malis Coagulators; Stimulators, Muscle; Surgical Diathermy Units;
Surgical Units; Wapplers; Apparatus, electrosurgical; Surgical diathermy generator




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Ultrasonic fetal heart detectors are low-cost devices used in
a variety of healthcare settings to provide audible and visual
information about the fetus. The unit provides quick reassurance
of fetal well-being to both the mother and the healthcare worker.
Fetal heart detectors can easily detect fetal heart sounds
throughout the pregnancy, starting as early as 8 weeks. The
ability of most units to accurately calculate the fetal heart rate
has also made these devices valuable diagnostic tools.


Product description
Fetal heart detectors are devices that use ultrasonic waves to
provide audible and/or visual information. They consist of an
ultrasound-frequency electrical generator and appropriate
ultrasound transducers housed in a probe that is placed on
the maternal abdomen. Ultrasonic heartbeat detectors amplify
the audible frequency shift signal of the returned ultrasonic
waves and deliver it to speakers or headphones; the heart rate
is determined either by measuring the timing of the peaks in
the Doppler signal or, more accurately, by using automated
autocorrelation procedures. These devices can detect fetal heart
activity as soon as 10 weeks after conception. Advanced units
can even detect bidirectional blood fl ow, allowing the clinician
to evaluate maternal vessels, such as the uterine artery.


Principles of operation
Fetal heart detectors transmit high-frequency sound waves
either continuously or in pulses. In continuous-wave (CW)
units, a crystal vibrates as an electrical current passes through
it, creating and transmitting acoustic energy, while a second
crystal detects echoes from structures in the body. In pulsed-
Doppler systems, a single crystal alternately transmits periodic
bursts of ultrasonic waves and senses the echoed energy. In both
systems, the refl ected wave is reconverted to an electrical signal
that can be used to create an audible sound or a waveform.
Ultrasonic heartbeat detectors amplify the audible frequency
shift signal of the returned ultrasonic waves and deliver it to
speakers or headphones; the heart rate is determined either by
measuring the timing of the peaks in the Doppler signal or by
using automated autocorrelation procedures.


Operating steps
An acoustic coupling gel is spread over the skin to facilitate the
effi cient transmission of ultrasound waves into and out of the
body. The probe is placed against the mother’s abdomen. If the
scanned structures are in motion, the frequency of the returning
sound waves changes in proportion to the velocity and direction
of the moving structures. Fetal heart detectors amplify this
audible frequency change, known as Doppler shift, and channel
it to speakers or headphones.


Reported problems
Although researchers have yet to establish
whether a signifi cant risk exists, there is some
concern about whether exposure to ultrasonic
energy during diagnostic procedures is safe.
Many factors can affect the ability of the unit
to detect the fetal heartbeat (i.e., body fat and
blood fl ow can absorb acoustic energy). Since
pathogens may be present on the patient’s
skin, transmission of these organisms to the
transducer head commonly occurs.


Use and maintenance
User(s): Physicians, obstetric nurses,
community midwives


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Obstetrics (hospital, OB/GYN
practices), emergency medicine


Requirements: Battery, uninterruptible power
source (recharge batteries), appropriate
transducer with gel


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 1


Consumables: Batteries, gel


Price range (USD): 350 - 800


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Portable, handheld, tabletop units


Fetal Heart Detector, Ultrasonic
UMDNS GMDN
11696 Detectors, Fetal Heart, Ultrasonic 35068 Foetal heart detector, ultrasonic


Other common names:
Ultrasonic stethoscopes; fetal Dopplers; Monitor, heart rate, fetal ultrasonic; Monitor, heart sound, fetal, ultrasonic;
monitor, hemic sound, ultrasonic.




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© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Electronic fetal monitoring (EFM) provides graphic and numeric
information on fetal heart rate (FHR) and maternal uterine
activity (UA) to help clinicians assess fetal well-being before and
during labor. FHR often exhibits decelerations and accelerations
in response to uterine contractions or fetal movements; certain
patterns are indicative of hypoxia. Examination of these patterns,
the baseline level, and variability characteristics can indicate
the need to alter the course of labor with drugs or perform an
operative delivery.


Product description
Fetal monitors are bedside units that consist of a monitoring unit,
cables, and electrodes. They are designed to measure, record, and
display FHR, uterine contractions, and/or maternal blood pressure
and heart rate before and during childbirth. These monitors
may sense FHR and uterine contraction indirectly through the
mother’s abdomen and/or directly by placing an electrode on
the fetal scalp (or other exposed skin surface) and measuring the
change in pressure within the uterus. Antepartum fetal monitors
are typically used in physician’s offi ces and clinics long before the
beginning of labor. Most hospital-based monitors have additional
capabilities, including fetal and maternal ECG recording.


Principles of operation
Fetal monitors detect FHR externally by using an ultrasound
transducer to transmit and receive ultrasonic waves; the
frequency (or Doppler) shift of the refl ected signal is proportional
to the velocity of the refl ecting structure—in this case, the fetal
heart. A transducer contains one or more piezoelectric elements
that convert an electrical signal into ultrasonic energy that can
be transmitted into tissues. When this ultrasonic energy is
refl ected back from the tissues, the transducer reconverts it to
an electrical signal that can be used to create a waveform for
display and recording and an audible FHR (sound created by the
frequency shift of the ultrasonic signal).


Operating steps
Continuous electronic FHR monitoring can be performed
indirectly, by applying an ultrasound transducer to the mother’s
abdomen, or directly, by attaching an electrode assembly to
the fetus after rupture of the amniotic membranes. Uterine
contractions can be recorded along with FHR by placing a
pressure transducer on the mother’s abdomen or by directly
measuring the change in pressure in the uterus with a catheter.


Reported problems
Common errors include doubled or halved rates, masked
fetal arrhythmias, and presentation of the maternal heart
rate as the FHR. Another error is the report of false FHR
decelerations during uterine contractions due to ultrasonic
signal-processing circuits holding the last FHR on occasional
signal peaks during noisy signals. Reported complications


of fetal scalp electrode application include
infection, uterine perforation, and soft tissue
injuries; mostly resulting from poor technique.
Some investigators have expressed concern
about the possible risks associated with fetal
exposure to ultrasound.


Use and maintenance
User(s): Physicians, obstetric nurses,
community midwives


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Obstetrics (hospital, OB/GYN
practices), emergency medicine


Requirements: Uninterruptible power source,
battery backup, appropriate transducer/
electrodes/sensors


Product specifi cations
Approx. dimensions (mm): 100 x 150 x 200


Approx. weight (kg): 6


Consumables: Batteries, cables, electrodes/
sensors, gel


Price range (USD): 1,200 - 15,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Tabletop, cart, some portable


Fetal monitor
UMDNS GMDN
18339
18340


Monitors, Bedside, Fetal, Antepartum
Monitors, Bedside, Fetal, Intrapartum


43958 Foetal cardiac monitor


Other common names:
Cardiotocographs; fetal electrocardiogram (ECG) monitors; fetal heart rate monitors; ultrasonic fetal monitors; Monitor,
cardiac, fetal; Monitor, heart valve movement, fetal, ultrasonic; Monitor, phonocardiographic, fetal.




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
Used to test for and manage diabetes by measuring blood
glucose levels; also used to test for transient high or low glucose
levels (e.g., during surgery); they are also used in sports medicine.


Product description
Handheld device with a display (usually LCD), a keypad to enter
information, and a slot to insert a test strip containing a drop
of blood which is tested for glucose. Some models may have
alarms, memory functions, touchpens, USB ports or wireless
features to transfer data to a computer, and/or a small storage
compartment for test strips.


Principles of operation
In optical BGMs, the blood sample is exposed to a membrane
covering the reagent pad, which is coated with an enzyme
(glucose oxidase, glucose dehydrogenase). The reaction
causes a color change; the intensity of this change is directly
proportional to the amount of glucose in the blood sample.
Light from an LED strikes the pad surface and is refl ected to a
photodiode, which measures the light’s intensity and converts
it to electrical signals. Electrochemical BGMs use an electrode
sensor to measure the current produced when the enzyme
converts glucose to gluconic acid. The resulting current is
directly proportional to the amount of glucose in the sample.


Operating steps
The test strip is inserted into the device either before or after the
addition of blood to the pad; timing begins automatically when
the monitor senses blood on the strip. Within seconds, a reading
is taken and displayed.


Reported problems
Outdated or improperly stored test strips can produce
inaccurate glucose readings. Healthcare personnel who use
BGMs in multiple-patient facilities should be aware of the risk of
exposure to potentially infectious bloodborne pathogens during
testing and cleaning procedures. Cross-contamination can occur
if appropriate infection control measures are not taken. Lancing
devices can cause needlestick injuries.


Use and maintenance
User(s): Patient, clinician, nurse


Maintenance: Patient or clinician


Training: Training manual


Environment of use
Settings of use: Home, hospital, physician
clinic


Requirements: NA (battery-operated
handheld devices do not have special settings
requirements)


Product specifi cations
Approx. dimensions (mm): 90 x 50 x 100


Approx. weight (kg): 0.65


Consumables: Test strips, batteries


Price range (USD): 15 - 1500


Typical product life time (years): 5-7


Shelf life (consumables): Test strips: 6 months


Types and variations
Specialized devices for neonate may be
available; some devices not intended for use
with neonates; some models allow alternate-
site testing (fi ngertip, forearm, palm)


Glucose Analyzer
UMDNS GMDN
16488
15102


Analyzers, Point-of-Care, Whole Blood Glucose
Analyzers, Laboratory, Body Fluid, Glucose


56684
56685


44206


Home-use/point-of-care glucose analyser IVD
Battery-powered Home-use/point-of-care
glucose analyser IVD
Line-powered Laboratory glucose analyser
IVD, automated


Other common names:
Glucometers, glucose meters, glucose monitors, blood sugar meters




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Used to count blood cells. An abnormal red cell count may indicate
polycythemia or anemia, which occurs because of blood loss,
failure of the bone marrow to produce RBCs, vascular hemolysis,
hypersplenism, or defi ciencies of iron, vitamin B12, or folic acid.
Abnormal white cell counts may indicate allergies, bacterial
or viral infections, infl ammatory disorders, tumors, tissue
destruction, toxic metabolic states, leukemia, myeloproliferative
syndromes, parasitic infecitons, or typhoid fever.


Product description
Handheld device or benchtop device, sometimes placed on a
cart, with a display (usually LCD), a keypad to enter information,
and a slot to insert a test strip or sample tube. Some models
may have alarms, memory functions, touchpens, USB ports to
transfer data to a computer, and/or a small storage compartment
for reagents.


Principles of operation
Red blood cell, white blood cell, and platelet counts are obtained
using the volumetric impedance technique, which creates pulses
which are amplifi ed; the magnitude of the pulse is directly
proportional to the volume of the cell. Another method is the
light-scatter technique, which counts and sizes cells by detecting
the amount of light scattered by a stream of hydrodynamically
focused cells. Within minutes of placing the sample into the
analyzer, the sample’s cells have been quantifi ed, and results are
analyzed and displayed.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,
or on test strips, and loaded into the analyzer. The operator may
select the tests being performed on the sample using a keypad
or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital, patient bedside,
physician offi ce, clinical laboratory, home


Requirements: Battery-operated handheld
devices do not have special settings
requirements; benchtop units require line
power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 400


Approx. weight (kg): 1-5 for handheld units;
15-25 for benchtop units


Consumables: Reagent cartridges or test
strips, batteries


Price range (USD): 191 - 28,000


Typical product life time (years): 4-6


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Handheld, portable, benchtop


Hematology Point of Care Analyzer
UMDNS GMDN
18513 Analyzers, Point-of-Care, Whole Blood, Hematology 35476 Haematological cell analyser IVD, automated


Other common names:
POC Analyzer, hematology analyzer; Analyser, laboratory, haematology, cell counting, automated




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These devices perform extracorporeal dialysis to replace the
main activity of the kidneys in patients with impaired renal
function, such as those with end-stage renal disease.


Product description
Single-patient hemodialysis systems can be divided into
three major components: the dialysate delivery system, the
extracorporeal blood-delivery circuit, and the dialyzer.


Principles of operation
Single-patient hemodialysis systems can be divided into
three major components: the dialysate delivery system, the
extracorporeal blood-delivery circuit, and the dialyzer. Blood is
taken via the extracorporeal circuit, passed through a dialyzer
for solute and fl uid removal, and returned to the patient. Each
system has its own monitoring and control circuits. The delivery
system prepares dialysate—a solution of purifi ed water with an
electrolyte composition similar to that of blood—and delivers it to
the dialyzer. The external blood-delivery system (extracorporeal
blood circuit) circulates a portion of the patient’s blood through
the dialyzer and returns it to the patient. The dialyzer is a
disposable component in which solute exchange, or clearance,
takes place.


Operating steps
Blood is taken via the extracorporeal circuit, passed through a
dialyzer for solute and fl uid removal, and returned to the patient.


Reported problems
Infections are a leading cause of morbidity and mortality
in chronic hemodialysis patients. For example, HBsAg (an
indicator for the presence of hepatitis B virus) has been
detected on various surfaces in hemodialysis centers. Strict,
specifi c policies and procedures designed to reduce infection
risks should be implemented. These policies should address
issues such as sterilization and disinfection, housekeeping,
laundry, maintenance, waste disposal, isolation precautions, and
universal precautions.


Use and maintenance
User(s): Nurse; dialysis technician


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Dialysis department at
hospitals; dialysis clinics


Requirements: Stable power source; water
treatment capability (e.g., reverse osmosis,
deionization)


Product specifi cations
Approx. dimensions (mm): 1680 x 510 x 640


Approx. weight (kg): 85


Consumables: Dialysate and administration
sets


Price range (USD): 37,000


Typical product life time (years): 5 to 7


Shelf life (consumables): variable and single
use


Types and variations
Single patient; multiple patient


Hemodialysis Unit
UMDNS GMDN
11218 Hemodialysis Units 34995 Haemodialysis system


Other common names:
Artifi cial Kidneys; Dialysis Machines; Hemodialyzers; Hemodialysis Machines; System, dialysate delivery, sealed; System,
dialysate delivery, sorbent regenerated; Haemodialysis apparatus




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Immunoassay analyzers test patient samples for a variety of
substances, including antiarrhythmic, antibiotic, anticonvulsant,
or cardiac glycoside drug concentration determination; infectious
diseases; allergy testing; cardiac markers; endocrine hormone
testing; and protein, viral, or bacterial toxin determinations.


Product description
Laboratory analyzers used to identify and quantify specific
substances, typically using an antibody (e.g., immunoglobulin)
as a reagent to detect the substance (i.e., antigen, hapten) of
interest. These analyzers typically include an autosampler,
a reagent dispenser, a washer, and a detection system.
Configuration and levels of sophistication, as well as available
testing options, vary greatly.


Principles of operation
Labeled molecules are added to patient specimens and passed
through a light of a particular wavelength. If the labeled
molecules bind to the molecules in the patient specimen, the
bound molecules will emit light. This indicates a positive result
that can then be quantified. The light signals are captured by a
detector and analyzed by the system’s computer. Models may
use an enzyme-substrate system, a fluorescent substance (either
a natural substance or a dye), or an acridinium ester or luminol.


Operating steps
The operator loads sample cells into the analyzer; reagents are
already stored in the instrument. Typically, a bar-code scanner
will read the test orders off the label on each test tube. The
analyzer will perform the required test(s), and the results can
be displayed on-screen, printed out, stored in the analyzer’s
internal memory, and/or transferred to a computer.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Laboratory technician


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Clinical laboratory


Requirements: Adequate benchtop or floor
space, water supply, line power, biohazard
disposal


Product specifications
Approx. dimensions (mm): 600 x 750 x 1,000


Approx. weight (kg): 10-60


Consumables: Reagents (cartridges, test
strips, etc.), reaction cuvettes


Price range (USD): 4,278 - 339,000


Typical product life time (years): 5-7


Shelf life (consumables): Reagents: 1-2 years


Types and variations
Enzyme, fluorescence, or chemiluminescence
methodolgies; some models can be interfaced
to an automated chemistry analyzer to
decrease operator intervention and possibly
improve workflow.


Immunoassay Analyzer
UMDNS GMDN
18625 Analyzers, Laboratory, Immunoassay 56724 Multichannel immunoassay analyser IVD,


automated


Other common names:
IA analyzer, EIA analyzer, FIA analyzer, CIA analyzer, enzyme photometric analyzer, immunofluorescence analyzer,
luminescent analyzer




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Health problem addressed
At birth, an infant’s core and skin temperatures tend to drop
signifi cantly because of heat loss from conduction, convection,
radiation, and water evaporation. Prolonged cold stress
in neonates can cause oxygen deprivation, hypoglycemia,
metabolic acidosis, and rapid depletion of glycogen stores.


Product description
Bassinets enclosed in plastic with climate controlled equipment
and hand-access ports with doors that are intended to keep
infants warm and limit their exposure to germs.


Principles of operation
These devices provide a closed, controlled environment that
warms an infant by circulating heated air over the skin. The heat
is then absorbed into the body by tissue conduction and blood
convection. Ideally, both the skin and core temperatures should
be maintained with only minor variations.


Operating steps
The neonate lies on a mattress in the infant compartment,
which is enclosed by a clear plastic hood. Incubators have hand-
access ports with doors that permit the infant to be handled
while limiting the introduction of cool room air. The clinician can
raise or remove the plastic hood or open a panel to gain greater
access to the infant.


Reported problems
Deaths and injuries to neonates in incubators have been linked
to thermostat failure that caused incubator overheating and
infant hyperthermia and to malfunctions or design defects that
produced fi res and electric shock hazards. Inadequate control
over the amount of oxygen delivered in an incubator can cause
hyperoxia or hypoxia.


Use and maintenance
User(s): Nursing staff


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital (primary care,
intermediate care, intensive care areas);
transport units used in ambulances


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 1326 x 1040 x 750


Approx. weight (kg): 93


Consumables: NA


Price range (USD): 13,000 - 43,000


Typical product life time (years): 7 to 10


Shelf life (consumables): NA


Types and variations
Incubator; incubator/warmer; transport;
mobile


Incubator, Infant
UMDNS GMDN
12113
17432
12114


Incubators, Infant
Incubators, Infant, Mobile
Incubators, Infant, Transport


35121
36025


Transport infant incubator
Conventional infant incubator


Other common names:
Beds, Infant; Combination Incubator/Warmers; Infant Incubators; Infant Warmers; Neonatal Care Stations; Transport
Incubators; Warmers; Thermostated transportable incubator; Incubator, neonatal transport




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The CO2 laser is applied extensively in gynecology, genitourinary,
plastic, dental, hepatic, orthopedic, and cardiovascular surgery
and are considered the mainstay of laser neurosurgery. They are
used for cutting, dissection, and coagulation of a wide range of
tissues.


Product description
Devices that typically consist of a laser tube, a laser pump, a
cooling system, an aiming laser, and a delivery system. A typical
CO2 laser delivery system consists of a hollow articulated arm
with mirrors set in each rotating joint so that the handpiece can
aim the beam in any direction. The handpiece has a focusing
lens to control spot size and focal length.


Principles of operation
CO2 lasers have two main modes of operation: continuous wave
(CW) and pulsatile (e.g., superpulse, pulser). In the CW mode,
the laser continuously delivers energy as long as the footpedal
is depressed. This mode releases the highest average power, but
it is the least precise of the operating modes. Pulsatile modes
allow the laser to fi re much shorter pulses than the CW mode.
Superpulse emits pulses that are 200 to 1,000 microseconds
(μsec) long; it is used when precise control is necessary. Pulser,
a second type of pulsatile mode, emits energy for 2 to 25
milliseconds (msec). A newer, highly developed type of pulsatile
mode is ultrapulse; the peak energy of each pulse in this mode
lasts longer than that of superpulse, subjecting tissue to a
substantially greater amount of energy per pulse.


Operating steps
These devices are intended to create surgical incisions, to
excise or vaporize deeper tissues (e.g., to remove tumors) after
incisions, to coagulate very small bleeding vessels, to vaporize
surface anomalies (e.g., warts), and to excise or vaporize tissue
accessible by both rigid and fl exible endoscopes.


Reported problems
Serious eye injuries have resulted from exposure to direct or
refl ected laser light; many of these injuries occurred because
eye protection was inappropriate. Fire is a risk, particularly
during laser surgery in the area of the head and neck. Oxygen
and nitrous oxide can enter the surgical site or collect in the
otopharyngeal cavity and increase the fl ammability of nearby
materials. Other risks include excessive bleeding resulting from
the CO2 laser’s inability to effectively coagulate blood vessels.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital; clinic; physician
offi ce


Requirements: Stable power source; smoke
evacuation


Product specifi cations
Approx. dimensions (mm): 350 x 400 x 1190


Approx. weight (kg): 49


Consumables: CO2 compressed gas


Price range (USD): 13,019-75,000


Typical product life time (years): 7


Shelf life (consumables): Variable


Types and variations
Free-fl owing tube; sealed tube


Laser, CO2
UMDNS GMDN
18203
18204
16942


Lasers, Carbon Dioxide
Lasers, Carbon Dioxide, Dental
Lasers, Carbon Dioxide, Surgical/Dermatologic


35939


47878


Surgical/dermatological carbon dioxide laser
system
Dental carbon dioxide laser system


Other common names:
Carbon Dioxide Lasers; Laser, ENT, microsurgical carbon dioxide; Laser, surgical, carbon dioxide, general-purpose;
Laser, surgical, carbon dioxide, speciality




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Health problem addressed
Devices used to coagulate abnormal vascular tissue in the retina.
Proliferation of such tissue (diabetic retinopathy) may lead to
blindness. They may create highly localized perforations in the
iris or in the trabecular meshwork to relieve excessive intraocular
pressure (glaucoma). They can also be used to reshape the
cornea to correct vision problems.


Product description
Most ophthalmic laser systems consist of a laser module—a
laser medium, laser pump, laser cavity, and cooling system that
is typically coupled to a slit-lamp biomicroscope by a flexible
fiberoptic cable. Other laser-energy delivery systems include
indirect ophthalmoscopes, intraocular probes, and interfaces for
operating microscopes.


Principles of operation
These devices are grouped into three main types:
photocoagulating lasers, photodisrupting lasers, and
photoablating lasers. Some ophthalmic lasers are also used for
photodynamic therapy. For photocoagulation ophthalmologists
use argon, dye, krypton, diode, and frequency-doubled Nd:YAG
lasers to coagulate abnormal vascular tissue in the retina. Dye
and diode lasers are being used in the photodynamic treatment
of intraocular tumors. Q-switched Nd:YAG ophthalmic lasers
are used for microsurgery in the anterior portions of the eye.
Excimer lasers are used in phototherapeutic keratectomy to
smooth over corneal scarring and remove calcification plaques,
in photorefractive keratectomy to shape the cornea to correct
myopia, and in automated lamellar keratoplasty to correct both
myopia and hyperopia.


Operating steps
The ophthalmologist views the structures within the patient’s
eye and aims and focuses the laser through the optics of the
slit lamp; when the laser is fired, the energy is delivered through
these optics or through coaxial optics.


Reported problems
Adverse outcomes include hemorrhage in and behind the retina,
retinal membrane contraction, atrophy of the iris, corneal edema
and neovascularization, loss of blue vision, changes in corneal
epithelial cell density, and increased intraocular pressure. Using
an Nd:YAG laser in the presence of an IOL can pit the lens,
affecting visual acuity.


Use and maintenance
User(s): Surgeon


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals; supervised training with experienced
surgeons


Environment of use
Settings of use: Hospital; clinic


Requirements: Stable power source


Product specifications
Approx. dimensions (mm): 130 x 220 x 250


Approx. weight (kg): 47


Consumables: NA


Price range (USD): 75,000


Typical product life time (years): 7


Shelf life (consumables): NA


Types and variations
With integrated slit lamp; without integrated
slit lamp


Laser, Ophthalmic
UMDNS GMDN
16945
17773
17808
17481
18224
17702
18227
16946
16947


Lasers, Argon, Ophthalmic
Lasers, Argon/Krypton, Ophthalmic
Lasers, Diode, Ophthalmic
Lasers, Dye, Ophthalmic
Lasers, Er:YAG, Ophthalmic
Lasers, Excimer, Ophthalmic
Lasers, Excimer/Ho:YAG, Ophthalmic
Lasers, Krypton, Ophthalmic
Lasers, Nd:YAG, Ophthalmic


16945
36171
44731

17481
17702
36532
16947


Ophthalmic argon laser system
Ophthalmic argon/krypton laser system
Ophthalmic diode-pumped solid-state laser
system
Ophthalmic dye laser system
Ophthalmic excimer laser system
Ophthalmic krypton laser system
Ophthalmic Nd:YAG laser system


Other common names:
Coagulators, Laser, Ophthalmic; Coagulators, Optical; Laser Coagulators, Ophthalmic; Photocauteries; Photocoagulation
Lasers; Photocoagulators; Semiconductor laser therapy equipment; Diode-pumped solid-state (DPSS) laser




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Mammographic radiographic units use x-rays to produce images
of the breast—a mammogram—that provide information about
breast morphology, normal anatomy, and gross pathology.
Mammography is used primarily to detect and diagnose breast
cancer and to evaluate palpable masses and nonpalpable breast
lesions.


Product description
A complete mammographic radiographic system includes
an x-ray generator, an x-ray tube and gantry, and a recording
medium. The x-ray generator modifies incoming voltage to
provide the x-ray tube with the power necessary to produce
an x-ray beam. They also include a “paddle” for compression
and placement of the breasts during imaging. Screen-film
systems consist of a high-resolution phosphorescent screen
with phosphor crystals that emit light when exposed to x-rays.
Digital mammographic computed radiography (CR) uses a
“digital” cassette to replace the traditional film cassette and
digital cassette reader, producing a digital image from the
cassette instead of developing film through a film processor.


Principles of operation
Low energy X-rays are produced by the x-ray tube (an evacuated
tube with an anode and a cathode) when a stream of electrons,
accelerated to high velocities by a high-voltage supply from the
generator, collides with the tube’s target anode. The cathode
contains a wire filament that, when heated, provides the electron
source. The target anode is struck by the impinging electrons.
X-rays exit the tube through a port window of beryllium.
Additional filters are placed in the path of the x-ray beam to
modify the x-ray spectrum. The x-rays that pass through the
filter are shaped by either a collimator or cone apertures and
then directed through the breast.


Operating steps
The mammography technician positions the patient, aligns
the X-ray tube for projection, compresses the patient’s breast
with the compression paddles, and then steps away to avoid
X-ray exposure before initiating the exposure to the patient.
Developed images are typically sent to a view box or work
station for viewing.


Reported problems
Historically, the most common problems associated with
mammography have not involved the units themselves but rather
are related to radiation exposure risks to patients. Inadequate
compression of the breast can cause poor image quality on
mammograms. Sagging of the breast during mediolateral oblique
and 90° lateral views, underexposure of the thick posterior part
of the breast and overexposure of the thin anterior part, blurring
of calcifications, and uneven exposure of fibroglandular tissue
can result if compression is not properly applied during imaging.


Use and maintenance
User(s): Radiology/mammography technican,
radiologist


Maintenance: Biomedical or clinical engineer/
technician, radilogy staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Radiology departments,
mammography clinics, stand-alone imaging
centers, mobile (i.e., trailer- or truck-based)
units


Requirements: Stable power source;
appropriate shielding; imaging workstations
or X-ray viewboxes


Product specifications
Approx. dimensions (mm): 1000 x 750 x 1000


Approx. weight (kg): 300


Consumables: NA


Price range (USD): 30,000-240,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Digital, film


Mammography unit
UMDNS GMDN
12425
18432


Radiographic Units, Mammography;
Radiographic Systems, Digital, Mammography


37672 Stationary mammographic x-ray system,
digital


Other common names:
Mammo units; X-ray system, diagnostic, mammographic, stationary, digital




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EEG monitors are used for observing and diagnosing a variety
of neurologic conditions, including epilepsy, related convulsive
disorders, and brain death. They can also be used to evaluate
psychiatric disorders and differentiate among various psychiatric
and neurologic conditions. In addition, electroencephalographic
studies with EEG monitors can assist in localizing tumors or
lesions on or near the surface of the brain.


Product description
EEG monitors use electrodes placed on a patient’s scalp to
measure, amplify, display in graphic form, and record the weak
electrical signals generated by the brain. They continuously
display processed EEG signals in graphic form over a period
of time so that waveform and pattern changes can be readily
detected. EEG monitors use computers to analyze and generate
large amounts of electroencephalographic data (as in Fourier
analysis), which are processed and displayed in various formats.
Many systems can produce and display certain types of EPs
or event-related potentials, a specific type of EEG signal that
occurs in response to a periodically applied external stimulus.


Principles of operation
Low-amplitude (microvolt range) EPs believed to be generated
by large numbers of nerve cells known as pyramidal cells, which
are located in the outer layer (cortex) of the brain, polarize
and depolarize in response to various stimuli, creating the EEG
waveform. These fluctuating electrical potentials are detected
by electrodes placed on the scalp and are displayed and/or
recorded on the EEG. Each EEG channel amplifies a signal from
a pair of electrodes, and these amplified signals can be printed
on a chart recorder and/or displayed on a monitor.


Operating steps
Scalp electrodes are usually affixed by a technician with a conductive
adhesive or paste. Cup, or disk, electrodes are affixed to the scalp
with a special adhesive called collodion or with a conductive paste.
Regardless of the electrode-placement procedure used, patients
usually lie down, remain awake, and keep their eyes closed during an
EEG recording; however, sleep EEG recordings (polysomnography)
are also common. The set of electrode pairs that the technician
selects for recording is called a montage.


Reported problems
The most common problem is improper electrode application.
Avoiding this problem requires use of proper technique during skin
preparation and electrode attachment, in addition to positioning
the electrodes in the correct system configurations. Poor electrode
contact with the scalp can distort the results of EEG recordings.
A recurring difficulty with electroencephalography is the failure of
EEG monitors to filter out artifacts, which can result in an incorrect
signal interpretation or inability to analyze the EEG signal.


Use and maintenance
User(s): Neurologists, neurosurgeons, or
other physicians, EEG technicians, sleep lab
technicians, nurses, anesthesiologists, OR
technicians,


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: ICUs, OR, sleep lab, EEG lab,
neurology clinics


Requirements: Uninterruptible power source,
battery backup, good lead/cable connections,
conductive gel


Product specifications
Approx. dimensions (mm): 350 x 50 x 390


Approx. weight (kg): 8


Consumables: Electrodes, conductive gel


Price range (USD): 1,750 - 113,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Computer laptop, mobile console, or monitor


Monitor, Bedside, Electroencephalography
UMDNS GMDN
12602 Monitors, Bedside, Electroencephalography 38736 Electroencephalographic monitoring system,


portable


Other common names:
Cerebral function monitors; EEG recorders; electroencephalographs; monitors, bedside, electroencephalography,
spectral




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Continuous monitoring is a valuable tool that helps provide
additional information to the medical and nursing staff about
the physiologic condition of the patient. Using this information,
the clinical staff can better evaluate a patient’s condition and
make appropriate treatment decisions and is used to treat a
wide range of patient conditions.


Product description
Depending on their confi guration, central monitors include
modules to measure varios parameters, including ECG,
respiratory rate, NIBP and IBP, body temperature, SpO2, SvO2,
cardiac output, ETCO2, intracranial pressure, and airway gas
concentrations. They include computing capabilities and
additional displays to observe trend information; some also
include full-disclosure capabilities. They do not replace bedside
monitors.


Principles of operation
Physiologic monitors can be confi gured, modular, or both.
Confi gured monitors have all their capabilities already built-in.
Modular systems feature individual modules for each monitoring
parameter or group of parameters; these modules can be used in
any combination with each bedside monitor or be interchanged
from monitor to monitor. Some physiologic monitoring systems
have the capabilities of both modular and confi gured systems.
With these monitors, frequently used parameters (e.g., ECG)
are confi gured to the monitor, but modules As monitoring data
is collected, some central stations are beginning to send the
information to the patient’s electronic medical record (EMR).


Operating steps
Receivers are connected to a bedside monitor and/or central
station monitor. Some central station monitors can be networked
so that a patient’s waveform can be simultaneously displayed
at multiple locations within a hospital. Some telemetry systems
allow receivers to be connected to a bedside monitor or to be
used on the same central station network as hardwired bedside
monitors. This allows the clinician to view a patient’s ECG and
other monitored information at the bedside and at the central
station.


Reported problems
Central monitors may tempt hospital personnel to pay more
attention to the equipment than to the patient connected to it.
Even monitors that are functioning reliably cannot substitute for
frequent direct observation. Frequent false positive alarms can
cause alarm fatigue and result in clinical staff missing critical
patient events like low oxygen saturation levels.


1. 99


2. 105


3. 66


TELEMETRY
CENTRAL STATION


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: General medical and surgical
areas, intermediate care/step down units,
cardiac rehab, telemetry units


Requirements: Uninterruptible power source,
redundant data backups


Product specifi cations
Approx. dimensions (mm): Varies by
confi guration selected


Approx. weight (kg): Varies by confi guration
selected


Consumables: None


Price range (USD): 4,500 - 40,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Desk mounted, bedside mounted


Monitor, Central Station
UMDNS GMDN
20179 Monitors, Central Station 38470 Patient monitoring system central station


monitor


Other common names:
Central station monitors, central monitoring, alarm monitoring center, alarm monitoring station; Monitoring central




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Health problem addressed
Continuous monitoring is a valuable tool that helps provide
additional information to the medical and nursing staff about
the physiologic condition of the patient. Using this information,
the clinical staff can better evaluate a patient’s condition and
make appropriate treatment decisions.


Product description
These systems usually include a central station monitor that
receives, consolidates, and displays the information and a set of
monitors that are deployed near the patient (bedside monitors)
to provide the required data from each patient (ECG, respiratory
rate, noninvasive blood pressure (NIBP) and invasive blood
pressure (IBP) (systolic, diastolic, and mean), body temperature,
(SpO2), mixed venous oxygenation (SvO2), cardiac output,
(ETCO2), intracranial pressure, and airway gas concentrations).


Principles of operation
Physiologic monitors can be confi gured, modular, or both.
Confi gured monitors have all their capabilities already built-
in. Modular systems feature individual modules for each
monitoring parameter or group of parameters; these modules
can be used in any combination with each bedside monitor or
be interchanged from monitor to monitor. Some devices have
the capabilities of both modular and confi gured systems. Many
physiologic monitoring systems include a central station capable
of displaying ECG waveforms and other information from any
bedside within the system, and many are equipped with alarms
that are coordinated with those at the bedside monitor.


Operating steps
Once patients are attached to the appropriate monitoring
electrodes/pads, the cables are connected to the physiologic
monitor. Then the monitor allows patients’ physiologic
parameters to be continuously monitored so that changes can be
identifi ed and, if necessary, treated. The monitored parameters
can be seen at the bedside and (if desired) shared with a central
station. System suppliers offer different monitoring options to
meet a variety of applications (such as critical care, the operating
room, or transport).


Reported problems
Poor electrode preparation and attachment are most commonly
reported. Cables and lead wires should be periodically inspected
for breaks and cracks. Loss of patient alarms, misleading alarms,
and parameter errors have been the causes of most monitor
recalls. Even monitors that are functioning reliably cannot
substitute for frequent direct observation. Many devices
produce frequent “false alarms” which can lead to alarm fatigue
and missed critical events.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital, inter- and intra-
hospital transport; mostly in intermediate
care/step down units and in general medical
and surgical areas


Requirements: Uninterruptible power source,
battery backup, good lead/pad/cable
connections


Product specifi cations
Approx. dimensions (mm): 375 x 275 x 238


Approx. weight (kg): 10


Consumables: Batteries, cables, sensors/
electrodes, cuffs


Price range (USD): 3,000 - 50,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Bedside mounted, pole mounted, wall
mounted, transport, handle


Monitoring System, Physiologic
UMDNS GMDN
12636 Monitoring Systems, Physiologic 33586


36872
35569


Physiologic monitoring system, single-patient
Transportable physiologic monitoring system
Neonatal physiologic monitoring system


Other common names:
Operating room (OR) monitors, acute care monitoring systems, vital signs monitors, neonatal monitors, physiologic
monitors; Single-patient monitoring system and related equipment; Measuring/monitoring system, biophenomena;
Monitoring, bedside unit; Single patient monitoring system; Monitor, patient transport; Physiologic monitoring system,
acute care, battery-powered; physiologic monitoring system, neonatal




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Health problem addressed
Continuous monitoring is a valuable tool that helps provide
additional information to the medical and nursing staff about
the physiologic condition of the patient. Using this information,
the clinical staff can better evaluate a patient’s condition and
make appropriate treatment decisions. Most commonly used
for treatment of patients with cardiac conditions.


Product description
Telemetric monitors designed for continuous measurement and
transmission of several vital physiologic parameters to a central
station or a bedside monitor. These monitors typically consist
of transmitters and electrodes, an antenna system or access
points, receivers, and a display screen and recorder. Telemetry
systems transmit physiologic parameters like ECG, NIBP, SpO2.


Principles of operation
Telemetric monitoring systems transmit patients’ physiologic
parameters to a central station display and/or a bedside
monitor. Data transfer is done to a remote location by means of
radio waves. Because they use radio-wave transmission, cables
are not required to connect the patient and transmitter to the
display monitor, thereby allowing greater patient mobility.


Operating steps
Appropriate monitoring electroed must be attached to the
patient. The cables are attached to the telemetry transmitter.
The transmitter sends physiologic monitored data to the central
station or bedside monitor that receives, consolidates, and
displays the information collected from one or more patients.


Reported problems
The frequency bands used by wireless medical telemetry
are getting crowded, putting medical telemetry at risk for
interference. Signal fading, during which the ECG signal is
momentarily lost, results in inaccurate ECG signals, false alarms,
and monitoring data loss. To reduce the potential of interference
from noise, hospitals should survey the installation site to ensure
that the antennae are properly placed, that no other equipment
operates at that frequency, and that no outside interference
impede telemetry signals.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Hospital; step-down/
intermediate care areas, cardiac rehab,
any area with mobile patients that require
physiologic monitoring


Requirements: Uninterruptible power source,
battery backup, good lead/pad/cable
connections


Product specifications
Approx. dimensions (mm): 124 x 70 x 35


Approx. weight (kg): 0.18


Consumables: Batteries, cables, sensors/
electrodes


Price range (USD): 2,300 - 150,000


Typical product life time (years): 7-10


Shelf life (consumables): NA


Types and variations
Telemetry pack worn by patient (e.g.,
pendant, strapped to arm, garment pouch)


Monitor, Telemetric, Physiologic
UMDNS GMDN
13987 Monitors, Telemetric, Physiologic 31733 Electrocardiography telemetric monitoring


system


Other common names:
Arrhythmia detectors, arrhythmia monitors, cardiac monitors, arrhythmia ECG monitors, telemetric ECG monitors,
electrocardiographic monitors, ECG physiologic telemetry units, telemonitors; ECG telephonic transmission equipment;
Monitor, telemetric, electrocardiography




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These devices are intended to treat renal failure, partially
replacing kidney function by removing metabolic wastes
through selective diffusion across the peritoneum.


Product description
These devices consist of a machine that performs automated
dialysis cycles (for CCPD), a catheter and a sterile disposable
tubing system.


Principles of operation
These devices perform three main types of PD therapy:
continuous ambulatory peritoneal dialysis (CAPD), intermittent
peritoneal dialysis (IPD), and continuous cyclic peritoneal
dialysis (CCPD). The type of therapy indicated depends on the
physician’s preference and profi ciency in the required aseptic
technique as well as on the patient’s condition. The most
commonly used type of therapy is CAPD, in which the patient
manually infuses dialysate from a portable plastic bag that is
usually worn until the dialysate is drained several hours later.
CAPD is inexpensive and can be performed almost anywhere if
strict aseptic technique is used. IPD can be performed manually
by the patient, a family member, or a nurse; it can also be
performed automatically with a PD unit.


Operating steps
A typical dialysis cycle consists of fi lling the peritoneal cavity
with a volume of dialysate, letting the dialysate remain within the
cavity for a selected period of time (dwell time) while diffusion
and osmosis occur, and draining the spent dialysate from the
peritoneal cavity.


Reported problems
Peritonitis (infl ammation of the peritoneum) is the most serious
complication of PD therapy. Poor aseptic technique often
introduces bacteria that are present on the hands or on the skin
surrounding the catheter site to the PD tubing, which can result
in peritonitis and catheter-site or tunnel infections. User error
has resulted in the accidental introduction of disinfectant into
the peritoneal cavity. Also, arthritic or very weak patients may
have diffi culty handling the tubing sets and drainage equipment.


Use and maintenance
User(s): Patient


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by dialysis department
staff


Environment of use
Settings of use: Hospital; dialysis clinic; home


Requirements: Stable power source (if using
continuous cycler-assisted peritoneal dialysis)


Product specifi cations
Approx. dimensions (mm): 215 x 455 x 385


Approx. weight (kg): 17


Consumables: Dialysate and administration
sets


Price range (USD): 7,000 - 13,000


Typical product life time (years): 5 -7


Shelf life (consumables): variable and single
use


Types and variations
Continuous ambulatory peritoneal dialysis
(CAPD); continuous cycler-assisted peritoneal
dialysis (CCPD)


Peritoneal Dialysis Unit
UMDNS GMDN
11226 Peritoneal Dialysis Units 11226 Peritoneal dialysis system


Other common names:
Artifi cial Kidney Machines; Cyclers, Peritoneal Dialysis; Dialysis Machines; Dialysis Units; Kidney Machines; Peritoneal
Dialysis Cyclers; PD Cyclers; Peritoneal Dialysis Drainage Systems; Automated peritoneal dialysis apparatus; System,
peritoneal, automatic delivery; Dialysis system, peritoneal




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Pulmonary function analyzers measure the performance of
a patient’s respiratory system, especially for outpatient or
presurgical screening. These systems measure the ventilation,
diffusion, and distribution of gases in the lungs. They are used
to help assess patients with conditions like chronic obstructive
pulmonary disorder (COPD).


Product description
Pulmonary function analyzers are designed to assess the
volume, airfl ow, and derived parameters through the respiratory
tract of adults and older children. These devices typically
include a spirometry instrument (e.g., pneumotachometer,
bellows, rolling-seal-type spirometer), a computer, a gas
analyzer, and an electronic unit with computerized capabilities
and appropriate software. In addition to diagnostic spirometer
measurements, they may measure parameters such as functional
residual capacity, diffusing capacity of the lungs for carbon
monoxide, and airway resistance. The analyzers are intended
to provide a baseline for ventilatory function as well as identify
respiratory impairments. Some systems include a total-body
plethysmograph for measuring lung volume and Raw.


Principles of operation
Spirometry instruments measure the volume of gases exhaled
by the patient (i.e., volume changes of the lungs) either by
volume displacement or fl ow sensing methods. Spirometers
measure the volume directly; these devices include water-seal
bellows and rolling-seal spirometers, or the fl ow of gas that
is integrated to yield volume. Such fl ow sensing instruments
can employ a pneumotachometer, a hot-wire anemometer, or
a turbinometer. Some analyzers incorporate computers with
software that permits customized reports or the inclusion of
specialized predictive equations for normal function.


Operating steps
The operator selects the desired parameters to be measured or
follows a procedure protocol; a spirometry instrument is held to
the patient’s mouth in order to measure exhaled breath. Results
are displayed onscreen and may be stored or printed out.


Reported problems
Computer software can be a signifi cant source of error, and a
manufacturer should be able to document the computational
algorithms of its software and demonstrate its accuracy.
Problems related to equipment failures of spirometers are
uncommon; some may result from misuse of a properly
functioning analyzer. The mouthpiece or tubing on a spirometry
instrument can provide a warm, moist environment favorable to
the growth and transmittal of disease-causing microorganisms.


Use and maintenance
User(s): Physicians, nurses, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Pulmonary medicine,
respiratory therapy, or general medicine
departments


Requirements: Uninterruptible power source,
battery backup, appropriate masks and tubing


Product specifi cations
Approx. dimensions (mm): 350 x 600 x 1,000


Approx. weight (kg): 50


Consumables: Tubing, masks


Price range (USD): 1,800 - 60,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Portable, cart, desktop, tabletop


Pulmonary function analyzer
UMDNS GMDN
13182 Analyzers, Physiologic, Respiratory Function


Mechanics, Adult
35282 Pulmonary function analysis system, adult


Other common names:
Respiratory function analyzers; respiratory function mechanics analyzers; Calculator, pulmonary function laboratory




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This technology is effective in arthrography, bronchography,
gastrointestinal and biliary tree studies, hysterosalpingography,
intravenous and retrograde pyelography, myelography, and
sialography. Other applications include locating ingested foreign
materials; localizing lesions for needle aspiration or biopsy;
highlighting congenital anatomic abnormalities; diagnosing
congestive heart failure; and evaluating chest pain.


Product description
These devices consist of a combination of a patient support unit
(usually a table base and a movable tabletop), an under-table
x-ray tube and holder, x-ray generators, a power-assisted spot-
fi lm device, an image intensifi er, radiation shields, a Bucky fi lm
tray, an overhead x-ray tube and ceiling support for follow-up
radiography, and a control panel.


Principles of operation
Most R/F systems allow spot fi lming of the image to produce
an x-ray fi lm for later detailed study by the radiologist and for
fi lm archiving. For routine radiography and follow-up x-ray
scans after studies that use contrast media (e.g., gastrointestinal
studies), most systems include an under-table Bucky tray for use
with an overhead x-ray tube.


Operating steps
Patients are positioned on the x-ray table and a catheter
inserted (procedure-dependent). The x-ray scanner will be used
to produce fl uoroscopic images. Depending on the procedure,
a dye or contrast substance may be injected into the patient via
an IV line in order to better visualize the organs or structures
being studied. After the procedure is complete the IV line will
be removed.


Reported problems
Typical problems include mechanical issues; unexpected failures
of safety features; overexposure or unexpected exposure to
radiation; breakage or weakening of mechanical supports;
overheating in drive motors; table misalignments; inadequate
radiation shielding; and noncompliance with regulatory codes.


Use and maintenance
User(s): Radiologic technician


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospitals; private practices;
clinics; stand-alone imaging centers


Requirements: Radiation shielding (room,
mobile, or overhead); stable power source


Product specifi cations
Approx. dimensions (mm): Confi gurable


Approx. weight (kg): Confi gurable


Consumables: NA


Price range (USD): 415,000 - 1,150,000


Typical product life time (years): 10


Shelf life (consumables): NA


Types and variations
Over- or under-table x-ray tube; C-arm;
remote control; direct control


Radiographic, Fluoroscopic System
UMDNS GMDN
16885 Radiographic/Fluoroscopic Systems, General-


Purpose
37645 Stationary basic diagnostic x-raysystem, digital


Other common names:
General-Purpose Radiographic/Fluoroscopic Systems; Radiographic/Fluoroscopic Units, General-Purpose; Tables,
Radiographic/Fluoroscopic; Direct-Controlled Radiographic/Fluoroscopic Systems; Remote-Controlled Radiographic/
Fluoroscopic Systems




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These systems are used mainly for treatment of cancer and
related diseases.


Product description
Computer workstations that typically consist of a computer,
software for dosage calculation, and input and output devices
(e.g., keyboards, monitors, printers) for graphic and alphanumeric
data. These systems use x-ray image data and dosimetric data
to help clinicians determine the optimum treatment parameters
to match the prescribed dose and constraints. Planning systems
are available for all types of radiation treatment delivery.


Principles of operation
Various computer algorithms are used to model the interactions
between the radiation beam and the patient’s anatomy to
determine the spatial distribution of the radiation dose. Different
algorithms are necessary to account for the different types
of radiation and computational complexity. With the increase
in computational performance available today, improved
algorithms are being developed. All treatment planning systems
use x-ray based image data since the x-ray data is necessary
for the dosimetry calculations. Most treatment planning systems
today use inverse planning, which works backwards from the
prescribed treatment volume to determine the optimum beam
angles and collimation.


Operating steps
The fi rst step in treatment planning is to identify the planning
target volume and the organs at risk. This is done by the
oncologist using the contouring tools available on the planning
system. Automatic contouring tools can help in outlining organs
or regions of bulk density. Depending on the type of lesion, it
may be necessary to use multiple images from different sources.
Alignment can be achieved using either implanted fi ducial
markers or anatomic structures. Dose calculation is central to all
treatment planning systems.


Reported problems
Several issues have been reported involving treatment delivery
errors due to incorrect calibration among third-party equipment,
treatment planning systems, and treatment delivery equipment.
These errors can affect multiple patients. Therefore, all those
involved in radiation oncology should be alert to any anomalies.


Use and maintenance
User(s): Medical physicists


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospitals; private practices;
clinics; stand-alone imaging centers


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): NA


Approx. weight (kg): NA


Consumables: NA


Price range (USD): 50,000 - 230,000


Typical product life time (years): 5 to 7


Shelf life (consumables): NA


Types and variations
Radiosurgery planning systems;
brachytherapy planning systems


Radiotherapy Planning System
UMDNS GMDN
21955 Workstations, Radiotherapy Planning 40996 Radiation therapy treatment planning system


Other common names:
Computers, Radiotherapy Planning System; Computers, Radiotherapy Treatment Planning; Computers, Radiotherapy,
Planning; Radiotherapy Planning Workstations; Radiotherapy Treatment Planning Systems; Treatment Planning
Systems;Radiotherapy, dose planning system; System, planning, radiation therapy treatment.




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Linear accelerators (linacs) and cobalt radiotherapy units are
used in external-beam radiation therapy to treat cancer. Cobalt
units and low-energy linacs are used primarily to treat bone
cancer and tumors of the head, neck, and breast. High-energy
linacs are used to treat deep-seated neoplasms and tumors of
the pelvis and thorax. Radiation is used to treat at least 50% of
all cancer cases. It can be either curative or palliative, depending
on the stage and prognosis of the disease.


Product description
Linacs emit a well-defined beam of uniformly intense x-ray
photon radiation of different energies, depending on the
accelerator. Some linacs also produce electron beams. Cobalt
radiotherapy units use a man-made radioisotope, cobalt-60,
to produce gamma-ray photons. Linacs consist of four major
components—a modulator, an electron gun, a radio-frequency
(RF) power source, and an accelerator guide. The electron beam
produced by a linac can be used for treatment or can be directed
toward a metallic target to produce x-rays. Linacs are classified
according to their energy levels, low, medium, and high.


Principles of operation
Linear accelerators accelerate electrons that collide with a heavy
metal target, scattering high-energy x-rays. A portion of these
x-rays is collected and shaped to form a beam that matches the
patient’s tumor. The beam comes out of a gantry which rotates
around the patient. The patient lies on a moveable treatment
couch and lasers are used to make sure the patient is in the
proper position. Radiation can be delivered to the tumor from
any angle by rotating the gantry and moving the treatment
couch.


Operating steps
A radiation therapist positions the patient on the unit’s table and
carefully aligns the patient with positioning lasers and fiducial
tattoos. Additional beam shaping elements are attached to the
collimator or are adjusted on the collimator. The therapist then
leaves the room and controls the delivery of radiation from a
separate control room.


Reported problems
Most radiation therapy-related errors and incidents have been
reported to be caused by use error. This can result in significant
under-dose or over-dose in the delivery of radiation. Errors can
also occur at the planning stage or in equipment calibration.
Missed clinical information at the planning stage has caused
severe (even fatal) radiation injury, and poor calibration can
lead to serious medical errors. Also, in several reported cases,
electromagnetic interference from a linear accelerator caused
infusion-pump failure when the pumps were being used on
patients undergoing radiation therapy.


Use and maintenance
User(s): Medical physicists; radiation therapy
technicians


Maintenance: Medical physicists; radiation
therapy staff; technicians; biomedical or
clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Radiation therapy department
or centers


Requirements: Stable power source; shielded
room and control room


Product specifications
Approx. dimensions (mm): 6500 x 7000 x
3200 (room size); 2500 x 500 (treatment
couch)


Approx. weight (kg): Variable


Consumables: NA


Price range (USD): 1,500,000-4,500,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Linear accelerators; Cobalt radiotherapy units


Radiotherapy Systems
UMDNS GMDN
16972
12364


Radiotherapy Systems, Cobalt;
Linear Accelerator


38297
35159


Teletherapy radionuclide system; Linear
accelerator system


Other common names:
Radotherapy systems, external beam radiation therapy systems, radiation therapy systems, LINAC; Cobalt radiotherapy
machine; Radioisotope teletherapy equipment; Radiotherapy unit, cobalt; Radionuclide system, therapeutic, teletherapy;
Medical linear accelerator




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These devices are most commonly used in conjunction with
external-beam radiotherapy, surgery, or chemotherapy to treat
endometrial, cervical, prostate, or pancreatic cancer; they are
also the primary treatment for soft-tissue sarcomas, vaginal
and rectal cancers, early-stage lip and tongue cancers, and
endobronchial carcinomas.


Product description
These systems are typically radioisotope delivery units (i.e.,
afterload unit) with a source-drive mechanism (usually a
computer-controlled stepper motor with drive rollers or belts),
applicators, a control console, and a computerized planning unit.


Principles of operation
Remote afterloading brachytherapy systems automatically
administer a radioisotope directly to cancerous tissue,
thereby minimizing the radiation dose to surrounding tissue
and eliminating the radiation exposure to hospital staff. The
amount of the radiation dose varies with the brachytherapy
method chosen for treatment delivery: low-dose-rate (LDR)
brachytherapy uses an implanted source that delivers a dose
of 40 to 60 centigrays (cGy) per hour over several days; high-
dose-rate (HDR) brachytherapy uses a traveling (stepping)
source that delivers a dose greater than 100 cGy per minute for
5 to 30 minutes; pulsed-dose-rate (PDR) brachytherapy uses a
cable-driven source delivering a dose of up to about 300 cGy
per hour for 10 to 30 minutes, repeated over several days.


Operating steps
After the treatment parameters have been tested, the source
drive mechanism, usually a computer-controlled stepper motor
with drive rollers or belts, advances the source from the shielded
safe through the guide tubes and into the treatment applicators.
The source guide tubes, also called transfer tubes, ensure
accurate source placement in the applicators. The indexer, which
typically provides 18 to 24 channels, facilitates source entry and
transfer for complex treatments requiring multiple applicators.


Reported problems
Most of the problems associated with brachytherapy are side
effects of radiation. Patients may develop localized irritation,
soft-tissue ulcerations, osteonecrosis, small-bowel perforations,
radiation mucositis, and abdominal fi stulas from implanted
radioactive sources. There have also been reports of dose
miscalculations and improper handling of source wires and
seeds by physicians, nurses, and medical physicists during
brachytherapy treatment.


Use and maintenance
User(s): Radiation physicist; licensed
dosimetrist (supervised by radiation
physicist); radiation oncologist


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital radiation oncology
department


Requirements: Stable power source; shielding
for treatment room and control room


Product specifi cations
Approx. dimensions (mm): 1330 x 540 x 790


Approx. weight (kg): 92


Consumables: NA


Price range (USD): 255,000 - 485,124


Typical product life time (years): 8 to 10


Shelf life (consumables): NA


Types and variations
High-dose-rate (HDR) brachytherapy; low-
dose-rate (LDR) brachytherapy; pulsed-dose-
rate (PDR) brachytherapy systems


Remote-afterloading brachytherapy system
UMDNS GMDN
20352
17517


Brachytherapy Systems
Brachytherapy Systems, Remote Afterloading


38300 Remote-afterloading brachytherapy system


Other common names:
Curietherapy Systems; Endocurietherapy Systems; Radiotherapy Units; Remote Afterloaders; Radionuclide system,
therapeutic, brachytherapy, remote afterloading; System, applicator, radionuclide, remote-controlled




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Health problem addressed
These scanners are used for a wide variety of diagnostic
procedures, including spine and head injuries, lesions, and
abdominal and pelvic malignancies; to examine the cerebral
ventricles, the chest wall, and the large blood vessels; and to
assess musculoskeletal degeneration.


Product description
Devices that consist of an x-ray subsystem, a gantry, a patient
table, and a controlling computer. A high-voltage x-ray generator
supplies electric power to the x-ray tube, which usually has a
rotating anode and is capable of withstanding the high heat
loads generated during rapid multiple-slice acquisition. The
gantry houses the x-ray tube, x-ray generator, detector system,
collimators, and rotational frame.


Principles of operation
CT scanners use slip-ring technology, which was introduced in
1989. Slip-ring scanners can perform helical CT scanning, in which
the x-ray tube and detector rotate around the patient’s body,
continuously acquiring data while the patient moves through
the gantry. The acquired volume of data can be reconstructed
at any point during the scan. All modern CT scanners are
multislice. Inside the gantry, an x-ray tube projects a fan-shaped
x-ray beam through the patient to the detector array. As the
x-ray tube and detector rotate, x-rays are detected continuously
through the patient. The computer mathematically reconstructs
data from each full rotation to produce an image of one slice.


Operating steps
During a CT scan, the table moves the patient into the gantry
and the x-ray tube rotates around the patient. As x-rays pass
through the patient to the detectors, the computer acquires and
processes data to form an image.


Reported problems
Controlling the radiation dose is the most signifi cant concern
facing all CT users. Also, unnecessary testing could cause an
overexposure to radiation. System problems and communication
breakdowns can result in repeat CT scans, and so, facilities need
to provide extensive training for these systems to eradicate
confusion when using the equipment.


Use and maintenance
User(s): Computed tomography scanning
technician


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospitals; private practices;
clinics; stand-alone imaging centers


Requirements: Stable power source; shielded
room and control room


Product specifi cations
Approx. dimensions (mm): 1882 x 2225 x 1006


Approx. weight (kg): 1906


Consumables: NA


Price range (USD): 329,900-3,200,000


Typical product life time (years): 8 to 10


Shelf life (consumables): NA


Types and variations
Multislice; 3-D CTA; 4-D imaging


Scanning System, CT
UMDNS GMDN
13469 Scanning Systems, Computed Tomography 37618 Full-body CT system


Other common names:
Computed Tomography Scanners; Computed Tomography Scanning Systems; Computed X-Ray Tomography Scanners;
Computer-Assisted Tomography Scanners; Computerized Tomographs; CT Scanners; CT Scanners, Mobile; CT Scanning
Systems; CT Slice Scanners; Multislice Scanners, Computer Tomography; Scanners, Computed Axial Tomography;
Scanners, Computed Tomography; Scanners; Computer Tomography, Mobile; Scanners, Computed Tomography, X-Ray;
Scanner, computed tomography, full-body; Whole body x-ray CT scanner




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Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
MRI is primarily used to identify diseases of the central nervous
system, brain, and spine and to detect musculoskeletal disorders.
It is also used to view cartilage, tendons, and ligaments. MRI
can also be used to image the eyes and the sinuses. MRI can be
used to help diagnose infectious diseases; to detect metastatic
liver disease; to display heart-wall structure; to stage prostate,
bladder, and uterine cancer; to evaluate kidney transplant
viability; and to study marrow diseases.


Product description
An MRI unit consists of a magnet, shimming magnets, an RF
transmitter/receiver system with an antenna coil, a gradient
system, a patient table, a computer, display monitors, and an
operator console. They typically have static magnetic fi elds
ranging from 0.064 to 3.0 T (as measured in the center of
the magnet bore). For comparison, the earth’s magnetic fi eld
is approximately 0.00006 T. Three basic magnet designs
are available for diagnostic MRI applications: the permanent
magnet, the resistive magnet, and the superconducting magnet.
Most systems today use a superconducting magnet. A standard
MRI suite comprises three main rooms: the procedure room, the
equipment room, and the control room.


Principles of operation
MRI units use strong electromagnetic fi elds and radio-frequency
radiation to translate the distribution of hydrogen nuclei in body
tissue into computer-generated images of anatomic structures.
MRI depends on the magnetic spin properties of certain atomic
nuclei in body tissue and fl uids and their behavior in the applied
magnetic fi eld. These nuclei are normally aligned randomly in
tissue until an external magnetic fi eld is applied and the nuclei
align themselves with that fi eld.


Operating steps
During an MRI scan the patient is moved into the bore of the MRI
magnet while the operator adjusts the controls depending on the
section(s) of the anatomy being scanned. Before the procedure
begins patients are checked for metal jewelry or other metal
objects which can distort the image or cause injury. Images are
processed by the MRI system’s computer and are generated for
viewing and diagnosis. Images are typically transferred to a
picture archiving and communication system.


Reported problems
Although the number of adverse incidents is relatively low,
numerous reports of injuries in MRI centers and a few reports
of deaths. Most of these incidents can be attributed to the
presence of ferromagnetic devices and equipment (including
implants) in the MR environment. Ferromagnetic objects have


become projectiles and injured or killed
patients. Several incidents have occurred
in which patients undergoing MRI studies
sustained second- and third-degree burns
when their skin contacted surface coils or
monitoring cables.


Use and maintenance
User(s): Radiologists, MRI technicians


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: MRI suite or clinic; operating
room


Requirements: Stable power source; shielded
room and control room


Product specifi cations
Approx. dimensions (mm): 2500 x 2500 x
2500


Approx. weight (kg): 5,500


Consumables: NA


Price range (USD): 150,000 - 3,100,000


Typical product life time (years): 8-10


Shelf life (consumables): NA


Types and variations
Extremity, full body, mammographic,
neurosurgical; various fi eld strength systems;
open or closed


Scanning System, Magnetic Resonance Imaging, Full-Body
UMDNS GMDN
18108 Scanning Systems, Magnetic Resonance Imaging,


Full-Body
37652
37653
37654


Full-body MRI system, permanent magnet
Full-body MRI system, resistive magnet
Full-body MRI system, superconducting
magnet


Other common names:
MRI systems; MRI scanners, MR scanners, magnetic resonance scanners




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Health problem addressed
These devices are used primarily for abdominal and OB/GYN
scanning. Some systems include additional transducers to
facilitate more specialized diagnostic procedures, such as
cardiac, vascular, endovaginal, endorectal, or small-parts (e.g.,
thyroid, breast, scrotum, prostate) scanning.


Product description
General-purpose ultrasonic scanning systems provide two-
dimensional (2-D) images of most soft tissues without subjecting
patients to ionizing radiation. These systems typically consist of
a beamformer, a central processing unit, a user interface (e.g.,
keyboard, control panel, trackball), several probes (transducers
or scanheads), one or more video displays, some type of
recording device, and a power system.


Principles of operation
Ultrasound refers to sound waves emitted at frequencies
above the range of human hearing. For diagnostic imaging,
frequencies ranging from 2 to 15 megahertz (MHz) are typically
used. Ultrasonic probes contain one or more elements made of
piezoelectric materials (materials that convert electrical energy
into acoustic energy and vice versa). When the ultrasonic
energy emitted from the probe is refl ected from the tissue, the
transducer receives some of these refl ections and reconverts
them into electrical signals. These signals are processed and
converted into an image. Lower sound frequencies provide
decreased resolution but greater tissue penetration, while
higher frequencies improve resolution when deep penetration
is not necessary.


Operating steps
To perform ultrasonic imaging, a probe is either placed on the
skin (after an acoustic coupling gel is applied) or inserted into a
body cavity. Scanned structures can be measured by ultrasound
technicians using digital calipers (i.e., cursors electronically
superimposed over the scanned cross-sectional image that
calculate the size of the scanned structure). The caliper system
can also be used by technicians to plot and measure the area,
circumference, or volume of a structure. A data-entry keyboard
permits information such as patient name, date, and type of
study to be entered and displayed along with the scanned image.


Reported problems
Ultrasound diagnostic imaging appears to be risk-free when used
properly. Ultrasound transducers should be handled carefully
to avoid damage. Electromechanical problems, such as cracks
in piezoelectric elements, can alter beam width and/or spatial
pulse length, thereby affecting lateral and axial resolution. Errors
in distance measurements can cause incorrect calculations.


Use and maintenance
User(s): Ultrasound technician


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital radiology
departments; private physician offi ces


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 1340x420x630


Approx. weight (kg): 75


Consumables: NA


Price range (USD): 25,000 -220,000


Typical product life time (years): 5


Shelf life (consumables): NA


Types and variations
General-purpose; OB/GYN; small parts;
vascular; cardiology; endocavity


Scanning System, Ultrasonic
UMDNS GMDN
15976 Scanning Systems, Ultrasonic, General-Purpose 40761 General-purpose ultrasound imaging system


Other common names:
Abdominal Ultrasound Scanners; Doppler Devices; General-Purpose Ultrasonic Scanners; Metal Detectors; Metal
Detectors, Ultrasonic; Scanners, Ultrasonic, Dedicated Linear Array; Scanners, Ultrasonic, General-Purpose; Scanners,
Ultrasonic, Pediatric; Ultrasound Scanners, Bladder; Ultrasound Scanners, General-Purpose; Ultrasound Scanners,
Urology; Diagnostic imaging equipment, general use




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Monitors partial pressure of CO2 at the skin surface of patients
at risk of hypoxia or inadequate ventilation or in whom clinically
signifi cant metabolic changes may be detected as changes in
tcpCO2 (e.g., patients under general anesthesia, patients with
emphysema). Transcutaneous blood gas monitoring can be
used as a supplement—or, in some cases, as an alternative—to
periodically drawing and analyzing arterial blood.


Product description
Rectangular or square device with wires connecting to patient
measurement sensors; additional input/output channels may be
available; display (LED, LCD) indicates patient blood gas levels;
buttons or dials for control settings; may include thermal printer;
sensors are usually small and round, attached to patient’s skin
with adhesive.


Principles of operation
TcpCO2 is monitored by a small sensor, which houses a pH
electrode, a reference electrode, an electrolyte solution, a Tefl on
membrane, and a heating element. An adhesive ring fastens the
sensor to the skin. The heating element warms the skin to 42° to
45°C. The CO2 that diffuses through the stratum corneum by the
warming of the skin passes across the sensor’s semipermeable
membrane and into a diluted bicarbonate solution (electrolyte
solution) in the sensor chamber. Adding CO2 lowers the pH of
the solution (increases acidity); a glass electrode measures the
change. The electrode’s output is converted into a signal, which
the instrument records as tcpCO2.


Operating steps
Sensors are affi xed to patient skin; device is programmed by
operator (i.e., turned on, measured parameters may be chosen);
device takes periodic or continuous blood gas measurements
and alarms if measurements are outside of normal range.
Periodically location of sensor must be changed to a different
place on patient’s skin to avoid irritation or burns, some devices
include a site-change timer.


Reported problems
Varying degrees of burns can result from the sensor’s elevated
temperature. Thin-skinned infants and patients with peripheral
vascular impairment are especially at risk. Frequent sensor
relocation, as recommended by the manufacturer, can help
prevent burns; however, sensor relocation often entails
recalibration.


Use and maintenance
User(s): Medical staff


Maintenance: Biomedical or clinial engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital


Requirements: Line power


Product specifi cations
Approx. dimensions (mm): 100 x 300 x 200


Approx. weight (kg): 0.5-5


Consumables: Sensors, probes, calibration
materials


Price range (USD): 7,225 - 20,000


Typical product life time (years): 8


Shelf life (consumables): Disposable sensor
membranes: 2 weeks; reusable sensors: 2
months


Types and variations
Modular unit (connected to other patient
monitoring devices) or stand-alone;
specialized for adult, pediatric, or neonate;
most measure both tcpCO2 and tcpO2; some
measure tcpCO2 and SpO2; reusable or
disposable sensors


Transcutaneous Blood Gas Monitor
UMDNS GMDN
17996 Monitors, Bedside, Blood Gas, Transcutaneous 36898 Patient monitoring system module, blood gas,


transcutaneous


Other common names:
TcpCO2 monitor, breathing circuit monitor, CO2 monitor




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Ventilators provide temporary ventilatory support or respiratory
assistance to patients who cannot breathe on their own or who
require assistance to maintain adequate ventilation because of
illness, trauma, congenital defects, or drugs (e.g., anesthetics).


Product description
Ventilators consist of a fl exible breathing circuit, a control system,
monitors, and alarms. The gas is delivered using a double-limb
breathing circuit. The gas may be heated or humidifi ed using
appropriate devices. The exhalation limb releases the gas to the
ambient air. Intensive care ventilators are usually connected to a
wall gas supply. Most ventilators are microprocessor controlled
and regulate the pressure, volume, and FiO2. Power is supplied
from either an electrical wall outlet or a battery.


Principles of operation
The control mode provides full support to patients who cannot
breathe for themselves. In this mode, the ventilator provides
mandatory breaths at preset time intervals and does not allow
the patient to breathe spontaneously. Assist/control modes
also provide full support by delivering an assisted breath
whenever the ventilator senses a patient’s inspiratory effort and
by delivering mandatory breaths at preset time intervals. With
volume-controlled breaths, a control system is used to ensure
that a set tidal volume is delivered during the inspiratory cycle.
Pressure-controlled breaths regulate fl ow delivery to attain and
sustain a clinician-set inspiratory pressure level for a set time so
that the ventilator delivers controlled or assisted breaths that
are time cycled. Combination modes are also available.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run
performance and calibration checks). They next make sure that
settings (including alarm levels) are correct and appropriate for
the patient type and condition. Once completed, the patient
is connected to the ventilator. When the ventilator-patient
connection is completed, users ensure the patient is being
properly ventilated. While patient is being ventilated, caregivers
monitor/evaluate the patient, and respond promptly to alarms.


Reported problems
Risk of acquiring pneumonia may be minimized by following
proper infection control procedures. Leaks in the breathing
circuit or components may prevent the ventilator from delivering
the appropriate amount of ventilation. Proper maintenance and
avoiding operator errors or machine failures can be critical.
Critical changes in patient conditions can be missed if alarms
are not set properly or are not noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory
therapist, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Intensive care, critical care
settings, surgery


Requirements: Uninterruptible power source,
battery backup, proper tubing/masks


Product specifi cations
Approx. dimensions (mm): 125 x 40 x 62


Approx. weight (kg): 67


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 9,000 - 60,000


Typical product life time (years): 8, depends
on hours used


Shelf life (consumables): NA


Types and variations
Cart or stand mounted


Ventilator, Intensive Care
UMDNS GMDN
17429 Ventilators, Intensive Care 42411 Intensive-care ventilator, adult/infant


Other common names:
IC ventilators, critical care ventilators, continuous ventilators, positive-pressure ventilators; Adult ventilator; Respirator,
general-purpose




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Neonatal intensive care ventilators provide ventilatory support
to preterm and critically ill infants who suffer from respiratory
failure and who generally have low-compliance lungs, small
tidal volumes, high airway resistance, and high respiratory
rates. These mechanical ventilators promote alveolar gas
exchange (oxygenation and carbon dioxide [CO2] elimination)
by generating positive pressure to infl ate the lungs of an infant
who is incapable of adequate independent breathing.


Product description
A typical neonatal ventilator system consists of a breathing
circuit, a humidifi cation system, gas-delivery systems, monitors
and their associated alarms, and gas sources for oxygen (O2)
and compressed air. Ventilators also require an integral or
add-on-oxygen-air proportioner (blender) to deliver a fraction
of inspired FiO2 between 21 and 100%. Controls are used to
determine the operating mode and ventilation variables. Most
ventilators have several operating modes.


Principles of operation
Intensive care ventilators designed for neonatal and/or pediatric
respiratory support are mostly time-cycled pressure-control
devices. CPAP is useful for infants with restrictive lung disease
or decreased lung compliance and alveolar collapse (infants with
hyaline membrane disease); PEEP maintains lung volume and
prevents alveolar collapse. High-frequency ventilation delivers
small tidal volumes around a near-constant mean airway pressure
(MAP) at frequencies higher than those produced during the
fastest possible panting (i.e., above 100 breaths per minute),
thus avoiding both high and low extremes of lung volume.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run
performance and calibration checks). They next make sure that
settings (including alarm levels) are correct and appropriate for
the patient type and condition. Once completed, the patient
is connected to the ventilator. When the ventilator-patient
connection is completed, users ensure the patient is being
properly ventilated. While patient is being ventilated, caregivers
should monitor/evaluate the patient, and respond promptly to
alarms.


Reported problems
Risk of acquiring pneumonia may be minimized by following
proper infection control procedures. Leaks in the breathing
circuit or components may prevent the ventilator from delivering
the appropriate amount of ventilation. Proper maintenance and
avoiding operator errors or machine failures can be critical.
Critical changes in patient conditions can be missed if alarms
are not set properly or are not noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory
therapist, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide


Environment of use
Settings of use: Neonatal intensive care unit
(NICU), pediatric intensive care unit (PICU),
critical care settings, surgery


Requirements: Uninterruptible power source,
battery backup, proper tubing/masks


Product specifi cations
Approx. dimensions (mm): 29 x 53 x 45


Approx. weight (kg): 27


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 7,500 - 45,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Cart or stand mounted


Ventilator, Intensive Care, Neonatal/Pediatric
UMDNS GMDN
14361 Ventilators, Intensive Care, Neonatal/Pediatric 14361 Intensive-care ventilator, neonatal/paediatric


Other common names:
Continuous ventilators, neonatal ventilators, pediatric ventilators, positive-pressure ventilators, time-cycled ventilators;
Ventilator, infant




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© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Portable ventilators deliver room air or oxygen-enriched gas
into the breathing circuit, where it can be humidifi ed by a heated
humidifi er or a heat and moisture exchanger before delivery to
the patient. They provide long-term support for patients who do
not require complex critical care ventilators. They can be used
for treating patients with conditions like pneumonia or during
mass casualty events.


Product description
Ventilators designed to provide support to patients who do
not require complex critical care ventilators. These ventilators
typically consist of a fl exible breathing circuit, a control system,
monitors, and alarms. Some systems may also include specialized
breathing circuits, oxygen accumulators, and heated humidifi ers
or heat and moisture exchangers (HMEs). Most devices use
positive pressure to deliver gas to the lungs at normal breathing
rates and tidal volumes through an endotracheal tube, a
tracheostomy cannula, or a mask. Power is typically supplied
from a power line or from an internal or external battery (e.g., a
car battery). These ventilators are used for long-term respiratory
support in extended care facilities and in the home; they may
also be used in emergency care.


Principles of operation
Portable ventilators deliver room air or O2-enriched gas into
the breathing circuit, where it can be humidifi ed by a heated
humidifi er or an HME before delivery to the patient. Typically,
these ventilators drive air into the breathing circuit with a
motor-driven piston or turbine. In the home setting, O2 is usually
delivered directly into the breathing circuit from a separate
source, such as an O2 tank. Most devices use positive pressure
to deliver gas to the lungs at normal breathing rates and tidal
volumes through an endotracheal tube, a tracheostomy cannula,
or a mask. Portable/home care ventilators may use several
methods of cycling (e.g., volume, time) and several ventilation
modes, including control, assist/control, and synchronized
intermittent mandatory ventilation (SIMV) modes.


Operating steps
Users fi rst check that the unit is ready for use (e.g., run
performance and calibration checks). They then make sure
that settings (including alarms) are correct and appropriate for
the patient type and condition. Once completed, the patient
is connected to the ventilator. When the ventilator-patient
connection is completed, users ensure that the patient is being
properly ventilated. While patient is being ventilated, caregivers
are responsible for monitoring/evaluating the patient, and for
promptly responding to alarms.


Reported problems
Most of the reported problems involving portable ventilators
arise from user error, poorly maintained exhalation valve
assemblies, and the use of poor-quality breathing circuits. Other


issues include disconnection of the breathing
circuit from the device, equipment failure,
disconnection/kinking/bending of tubing,
and extreme environmental conditions. Also,
critical changes in patient conditions can be
missed if alarms are not set properly or are not
noted by clinical staff.


Use and maintenance
User(s): Physicians, nurses, respiratory
therapist, other medical staff


Maintenance: Biomedical or clinical engineer/
technician, medical staff, manufacturer/
servicer


Training: Initial training by manufacturer,
operator’s manuals, user’s guide; clinical staff
to assist family with home care operation


Environment of use
Settings of use: Home care, long-term care
facilities, patient transport vehicles


Requirements: Battery, uninterruptible power
source (for recharging batteries), proper
tubing/masks


Product specifi cations
Approx. dimensions (mm): 150 x 250 x 300


Approx. weight (kg): 7


Consumables: Batteries, tubing, masks, fi lters


Price range (USD): 3,300 - 13,500


Typical product life time (years): 8


Shelf life (consumables): Variable


Types and variations
Portable, carrying case


Ventilator, Portable
UMDNS GMDN
17423 Ventilators, Portable 47083 Portable ventilator, electric


Other common names:
Continuous ventilators; home care ventilators; positive-pressure ventilators; time-cycled ventilators; Continuous,
ventilator, home-use; Portable / home-use ventilator




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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These systems are used for diagnosis and prescription of
medical treatment for patients at remote locations, for remote
clinical consultations between medical professionals, for
education and training of medical staff, and for administrative/
business functions. Telemedicine can be as simple as a telephone
conversation between personnel or a fax transmission, or as
complex as a real-time interactive video examination of a patient
conducted by physicians separated by hundreds of miles.


Product description
Components of a telemedicine videoconferencing system vary,
depending on the confi guration chosen by the buyer. In general,
system components include a codec, viewing monitor(s),
camera(s), control/user interaction devices (e.g., mouse,
keyboard,) input devices (e.g., document scanner, medical
scopes), and output and storage devices (e.g., printers, CD-ROM
drives). Most suppliers offer different confi gurations customized
to the buyer’s needs.


Principles of operation
Telemedicine videoconferencing uses video and
telecommunications technology to transmit medical information
(audio, video, and graphics) between two or more sites.


Operating steps
Patient examinations are conducted using instruments (e.g.,
stethoscopes, ophthalmoscopes) and examining cameras
connected to the telemedicine system, allowing a physician
at a remote site real-time access to the patient and real-time
interaction with the examining physician, physician assistant, or
nurse. A technician or nurse typically operates the instruments
with the patient in an examination room. Images and data
are then transmitted to the remote physician for viewing and
analysis, and interacting with the patient.


Reported problems
The telemedicine system should have some form of security
to avoid problems with data confi dentiality. Electric
fl uctuations can damage computer components, impair system
performance, disrupt program operation, and destroy data.
Preventive measures include installing an online uninterruptible
power supply. A dedicated power line isolated for the central
processing unit may be useful to reduce signal noise. Copying
disks at regular intervals protects stored information.


Use and maintenance
User(s): Physicians, medical professionals,
administrators, students


Maintenance: Technicians; IT staff; biomedical
or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospitals; private practices;
clinics; schools


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): NA


Approx. weight (kg): NA


Consumables: NA


Price range (USD): 1,495 - 177,000


Typical product life time (years): 5 to 7


Shelf life (consumables): NA


Types and variations
Mobile (rollabout); group (room); desktop


Videoconferencing system, Telemedicine
UMDNS GMDN
18138 Information Systems, Telemedicine,


Videoconferencing
36303 Video conferencing telemedicine system


Other common names:
Teleconferencing Systems, Video; Teleconsultation Systems; Telemedicine Videoconferencing Systems; Video
Teleconferencing Systems; Videoconferencing Systems, Telemedicine




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Health problem addressed
These devices are commonly used to provide thermal
support for newborns in the delivery suite, for critically ill
infants who require constant nursing intervention, and for
infants undergoing treatment that prolongs exposure to a
cool environment. Prolonged cold stress can overwork heat-
producing mechanisms, drain energy reserves, and result in
hypoxia, acidosis, hypoglycemia, and, in severe cases, death.


Product description
Infant radiant warmers are overhead heating units. They typically
consist of a heat source, a skin-temperature sensor, an automatic
(servo) control unit, and visual and audible alarms.


Principles of operation
A heating element generates a signifi cant amount of radiant
energy in the far IR wavelength region (longer than three microns
to avoid damaging the infant’s retina and cornea). The radiant
output of the heating unit is also limited to prevent thermal
damage to the infant. The IR energy is readily absorbed by the
infant’s skin; increased blood fl ow in the skin then transfers heat
to the rest of the body by blood convection (heat exchange
between the blood and tissue surfaces) and tissue conduction
(heat transfer between adjacent tissue surfaces).


Operating steps
After birth, infants are placed under a radiant warmer until they
can achieve thermoregulation.


Reported problems
Because warming by IR energy is an effi cient means of energy
transfer, extreme hyperthermia, skin burns, permanent brain
damage, or even death can result.


Use and maintenance
User(s): Nursing staff; physicians


Maintenance: Medical staff; technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital; birthing center


Requirements: Stable power source


Product specifi cations
Approx. dimensions (mm): 2100x1310x750


Approx. weight (kg): 110


Consumables: NA


Price range (USD): 3,250 - 26,000


Typical product life time (years): 8


Shelf life (consumables): NA


Types and variations
Freestanding; modular; permanently-mounted


Warming Unit, Radiant, Infant
UMDNS GMDN
17956
17433
12113


Warming Units, Patient, Radiant, Infant
Warming Units, Patient, Radiant, Infant, Mobile
Incubators, Infant


36812
17433


Infant/regional-body warmer
Infant warmer


Other common names:
Beds, Infant; Combination Incubator/Warmers; Infant Warmers; Mobile Warmers; Transport Warmers; Transport Radiant
Warmers; Warmers, Infant, Radiant, Stationary




http://www.who.int/medical_devices/en/index.html
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).


Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.


© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.


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Devices that measure the clotting mechanisms of hemostasis;
used primarily to detect clotting defi ciencies related to
thromboembolytic disease, thrombocytopenia, impaired
liver function, hemophilia, von Willebrand disease, and other
conditions. They are also used to monitor the effect of drugs
such as heparin, oral anticoagulants, and thrombolytic and
antiplatelet agents on whole blood, as well as the effects of
blood component therapy.


Product description
Handheld device or benchtop device, sometimes placed on a
cart, with a display (usually LCD), a keypad to enter information,
and a slot to insert a test strip or sample tube. Some models
may have alarms, memory functions, touchpens, USB ports to
transfer data to a computer, and/or a small storage compartment
for reagents.


Principles of operation
One of three methods may be used: Mechanical impedance
uses blood viscosity changes to determine clotting time.
Instruments using the photometric principle monitor changes
in the specimen’s optical density to detect the beginning of clot
formation. The electromagnetic uses a magnet in the test tube
aligned with a magnetic detector in the cuvette and remains
locked in position with the detector while the test tube rotates.
When a clot forms, it entangles the magnet, breaking the
electromagnetic coupling and allowing the magnet to rotate
with the tube, terminating the test.


Operating steps
Whole blood samples are placed in tubes, on reaction cuvettes,
or on test strips, and loaded into the analyzer. The operator may
select the tests being performed on the sample using a keypad
or connected computer.


Reported problems
Operators should be aware of the risk of exposure to potentially
infectious bloodborne pathogens during testing procedures and
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.


Use and maintenance
User(s): Medical staff


Maintenance: Laboratory technician;
biomedical or clinical engineer


Training: Initial training by manufacturer and
manuals


Environment of use
Settings of use: Hospital, patient bedside,
physician offi ce, clinical laboratory, home


Requirements: Line power, biohazard disposal


Product specifi cations
Approx. dimensions (mm): 200 x 150 x 300


Approx. weight (kg): 1-10


Consumables: Reagents (cartridges, test
strips, etc.), reaction cuvettes


Price range (USD): 648 - 46,000


Typical product life time (years): 5-8


Shelf life (consumables): Reagents: 2 years


Types and variations
Handheld, portable, benchtop; some models
may also test platelet function


Whole Blood Coagulation Analyzer
UMDNS GMDN
16749 Analyzers, Point-of-Care, Whole Blood, Coagulation 56689 Laboratory coagulation analyser IVD,


automated


Other common names:
Thromboelastograph, thrombometer; Analyser, laboratory, haematology, coagulation, automated






Core Medical Equipment




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