Medical equipment can present a variety of hazards including mechanical, electrical, fire-related, and those resulting from improper function or incorrect output. It is important to properly maintain equipment and perform safety testing using calibrated equipment to minimize risks to patients and users. Regular performance testing helps ensure medical devices are functioning as intended.
“Biomedical engineering is a discipline that
advances knowledge in engineering, biology and medicine, and improves human health through cross-disciplinary activities that integrate the engineering sciences with the biomedical sciences and clinical practice.”
A Bioamplifier is an electrophysiological device, a variation of the instrumentation amplifier, used to gather and increase the signal integrity of physiologic electrical activity for output to various sources. It may be an independent unit, or integrated into the electrodes.
The working of diffrent transducers and its priciples are discussed. The various types of sensors, transducers for the biopotential detections are also discussed with necessary diagrams.
تحميل برنامج فيس بوك بجميع الصور علي الهواتف و الكمبيوتر وز ماسنجر الفيس بوك , تطبيقات الفيس بوك علي الاندرويد و الايفون و الكثير
http://www.za-soft.com/%d8%aa%d8%ad%d9%85%d9%8a%d9%84-%d8%a8%d8%b1%d9%86%d8%a7%d9%85%d8%ac-%d9%81%d9%8a%d8%b3-%d8%a8%d9%88%d9%83-%d8%a3%d8%ad%d8%af%d8%ab-%d8%a5%d8%b5%d8%af%d8%a7%d8%b1/
“Biomedical engineering is a discipline that
advances knowledge in engineering, biology and medicine, and improves human health through cross-disciplinary activities that integrate the engineering sciences with the biomedical sciences and clinical practice.”
A Bioamplifier is an electrophysiological device, a variation of the instrumentation amplifier, used to gather and increase the signal integrity of physiologic electrical activity for output to various sources. It may be an independent unit, or integrated into the electrodes.
The working of diffrent transducers and its priciples are discussed. The various types of sensors, transducers for the biopotential detections are also discussed with necessary diagrams.
تحميل برنامج فيس بوك بجميع الصور علي الهواتف و الكمبيوتر وز ماسنجر الفيس بوك , تطبيقات الفيس بوك علي الاندرويد و الايفون و الكثير
http://www.za-soft.com/%d8%aa%d8%ad%d9%85%d9%8a%d9%84-%d8%a8%d8%b1%d9%86%d8%a7%d9%85%d8%ac-%d9%81%d9%8a%d8%b3-%d8%a8%d9%88%d9%83-%d8%a3%d8%ad%d8%af%d8%ab-%d8%a5%d8%b5%d8%af%d8%a7%d8%b1/
Российский государственный музей-заповедник"Тарханы"moiaav
Усадьба конца XVIII — начала XIX века, одно из наиболее известных лермонтовских мест России, где М.Ю. Лермонтов провёл детские годы. Усадьба расположена в селе Лермонтово (ранее это село называлось «Тарханы») Белинского района Пензенской области.
This was a presentation done team-wise in Manipal as part of our MBA assignments. The subject name was Operations Management and the presentation topics were different types of layouts. Our team got the topic Process Layout.
Private International Law in Myanmar and Myanmar Law of Contract by Oxford Pr...MYO AUNG Myanmar
https://www.law.ox.ac.uk/research-and-subject-groups/the-myanmar-law-of-contract
The Oxford-Burma/Myanmar Law Programme
The Myanmar Law of Contract
Private International Law in Myanmar
THE LAW OF CONTRACT IN MYANMAR
The Law of Contract in Myanmar by Adrian Briggs and Andrew Burrows was published in February 2017 and is the culmination of
one of the major projects of the Oxford – Burma/Myanmar Law Programme. The research and writing was primarily carried out in Oxford
using the facilities of the Bodleian Law Library and electronic databases but, in addition, short teaching visits were made
by the authors to Yangon where the opportunity was taken to talk with law faculty, practitioners and judges about the Myanmar law of contract.
CHAPTER 2FUNDAMENTALS OF NURSING POTTERATI FUNDAMEN.docxwalterl4
CHAPTER 2
FUNDAMENTALS OF NURSING: POTTER
ATI FUNDAMENTALS
CHAPTERS 1,2
SAFETY AND INFECTION CONTROL
SAFETY AND INFECTION CONTROL
CHAPTERS 27,28 FUNDAMENTALS OF NURSING
CHAPTER 10,11,12,13,14 ATI FUNDAMENTS
In patient safety, critical thinking is an ongoing process.Standards have been developed by American Nurses Association and The Joint Commission.Use of the nursing process when planning care promotes safety.
SAFETY AND INFECTION CONTROL
Safety in Health Care Organizations
A Safe EnvironmentIncludes meeting patients’ physical and psychosocial needsApplies to all places where patients receive careIncludes patients’ and health care providers’ well-beingReduces risk of injury and transmission of pathogensMaintains sanitation and reduces pollution
Environmental HazardsPhysical hazards: LightingObstaclesBathroom hazardsMotor vehicle accidentsPoisonFires
Falls
Transmission of pathogens
Pollution
Disasters
Natural
Man-made
Fire SafetyKeep open spaces (e.g., hallways) free of clutter.Make sure fire exits are clearly marked.Know the locations of all fire alarms, exits, and extinguishers.Know the telephone number for reporting fires.Know the agency’s fire drill and evacuation plans.Never use the elevator in the event of a fire.Turn off oxygen and appliances in the vicinity of a fire.In the event of fire, maintain the respiratory status of a client on life support manually with the use of an Ambu-bag (resuscitation bag) until the client can be moved away from the fire.Use the RACE mnemonic to set priorities in the event of a fire.Use the PASS mnemonic to remember how to use a fire extinguisher.
Evacuation Procedures
Ambulatory clients may be directed to walk on their own to a safe area and may be able to help move clients in wheelchairs.Bedridden clients are generally moved from the scene of a fire on stretchers, in their beds, or in wheelchairs.Appropriate transfer techniques must be used to carry a client from the area of a fire.Fire department personnel at the scene of a fire can help evacuate clients.
Safety - The Primary concern when caring for clients
All employees need to know:
the institution's fire evacuation routine
the location of fire alarms
the location of fire extinguishers
how to use the fire extinguisher
the location of fire exits
The "hang tag“ (ON FIRE EXTINGUISHERS) should be checked for date of last inspection (usually annually)
List the phone number for reporting fires close to all phones in the facility
facility rescue plans:
FIRE SAFETY
FIRE EXTNGUISHERS
The most common water extinguishers are suitable for class A fires only. Never use water to extinguish class C fires due to the risk of electrical shock.
Dry chemical extinguishers come in a variety of types and are suitable for a combination of class A, B, and C fires (liquids and electrical fires)
filled with foam or powder and pressurized with nitrogen
may leave a harmful residue that reduces the likelihood of re-ignition
Carbon dio.
Prevention of Accidents in An Operation Theatre Part 2-NURSINGMariaKuriakose5
This contains a detailed information about what causes accidents in an operation theater,its preventive measures and what else to be done to prevent such hazards taking place in an OT
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
India Diagnostic Labs Market: Dynamics, Key Players, and Industry Projections...Kumar Satyam
According to the TechSci Research report titled “India Diagnostic Labs Market Industry Size, Share, Trends, Competition, Opportunity, and Forecast, 2019-2029,” the India Diagnostic Labs Market was valued at USD 16,471.21 million in 2023 and is projected to grow at an impressive compound annual growth rate (CAGR) of 11.55% through 2029. This significant growth can be attributed to various factors, including collaborations and partnerships among leading companies, the expansion of diagnostic chains, and increasing accessibility to diagnostic services across the country. This comprehensive report delves into the market dynamics, recent trends, drivers, competitive landscape, and benefits of the research report, providing a detailed analysis of the India Diagnostic Labs Market.
Collaborations and Partnerships
Collaborations and partnerships among leading companies play a pivotal role in driving the growth of the India Diagnostic Labs Market. These strategic alliances allow companies to merge their expertise, strengthen their market positions, and offer innovative solutions. By combining resources, companies can enhance their research and development capabilities, expand their product portfolios, and improve their distribution networks. These collaborations also facilitate the sharing of technological advancements and best practices, contributing to the overall growth of the market.
Expansion of Diagnostic Chains
The expansion of diagnostic chains is a driving force behind the growing demand for diagnostic lab services. Diagnostic chains often establish multiple laboratories and diagnostic centers in various cities and regions, including urban and rural areas. This expanded network makes diagnostic services more accessible to a larger portion of the population, addressing healthcare disparities and reaching underserved populations. The presence of diagnostic chain facilities in multiple locations within a city or region provides convenience for patients, reducing travel time and effort. A broader network of labs often leads to reduced waiting times for appointments and sample collection, ensuring that patients receive timely and efficient diagnostic services.
Rising Prevalence of Chronic Diseases
The increasing prevalence of chronic diseases is a significant driver for the demand for diagnostic lab services. Chronic conditions such as diabetes, cardiovascular diseases, and cancer require regular monitoring and diagnostic testing for effective management. The rise in chronic diseases necessitates the use of advanced diagnostic tools and technologies, driving the growth of the diagnostic labs market. Additionally, early diagnosis and timely intervention are crucial for managing chronic diseases, further boosting the demand for diagnostic lab services.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
2. A hazard is any biological, chemical,
mechanical, environmental or physical
agent that is reasonably likely to cause
harm or damage to humans, other
organisms, or the environment in the
absence of its control.
2
Most hazards are dormant or potential, with only a theoretical
risk of harm; however, once a hazard becomes "active", it can
create an emergency. A hazardous situation that has come to
pass is called an incident. Hazard and possibility interact
together to create risk
3. 3
Medical electrical equipment can present a range of hazards
to the patient, the user, or to service personnel.
Many such hazards are common to many or all types of
medical electrical equipment, whilst others are peculiar to
particular categories of equipment.
The root causes for injures involving medical equipment include
Human Error, Faulty Equipment Design & Poor Maintenance.
However, It is unwise to assume anything until a through
investigation is made and failure analysis is performed on the
equipment.
4. 4
Electro-Surgery burns due to poor contact with grounding plate.
Punctured intestine due to insulation breakdown on laparoscope.
Death caused for an infant by vacuum & suction lines reversed on portable
suction machine. .
Infant brain damage due to defective valve design on portable oxygen unit.
Microshock electrocution due to broken ground wire in die injector line
cord.
Many such hazards are common to many or all types of
medical electrical equipment, whilst others are peculiar
to particular categories of equipment.
Listed below are various types of
common hazards.
5. 5
1 - Mechanical Hazards
2 - Risk of Fire or Explosion
3 - Absence of Function
4 - Excessive or Insufficient Output
5 - Infection
6 - Misuse
7 - Risk of exposure to spurious electric
currents
8 - Radiation
6. 6
All types of medical electrical
equipment can present mechanical
hazards.
These can range from insecure
fittings of controls to loose fixings of
wheels on equipment trolleys.
The former may prevent a piece of
life supporting equipment from
being operated properly, whilst the
latter could cause serious accidents
in the clinical environment.
7. The Enclosure
The enclosure of the device must be sufficiently strong to retain its integrity under
conditions of normal wear and tear
Handles of portable equipment are tested with a force of four times the weight of the
product. If there is more than one handle, this weight is distributed between the
handles.
Moving Parts
Moving parts which could produce a safety hazard must be suitable guarded
to prevent access, unless exposure is essential to the operation of the equipment.
If movement of the equipment, or parts of the equipment can cause injury to the
patient, this movement can only be achieved by continuous operation of the control by
the operator.
Any electrically controlled mechanical movement must have an emergency switch.
Sharp Edges
The device must not have sharp edges, corners, etc.
Stability
Medical devices must not overbalance when tilted to an angle of 10°.
7
8. 8
All mains powered electrical
equipment can present the risk of
fire in the event of certain faults
occurring such as internal or
external short circuits.
In certain environments such fires
may cause explosions. Although
the use of explosive anesthetic
gases is not common today, it
should be recognized that many of
the medical gases in use
vigorously support combustion.
9. Medical devices typically contain a number of
electro-mechanical and chemical systems and
power sources. Power can be supplied to an
actuating mechanism, or fluids and gases can be
handled through compression, dispersion or
valving. The devices typically contain items that
include foamed padding and/or structural
plastics. All of these things in combination
present an energy source for ignition, fuel and
oxidizer – good conditions for fire ignition and
propagation.
9
10. 10
Since many pieces of medical electrical equipment
are life supporting or monitor vital functions,
the absence of function of such a piece of
equipment would not be merely inconvenient, but
could threaten life
This recommend the use of proper test
equipments to verify the correct operation of the
equipment.
11. 11
In order to perform its desired function equipment must
deliver its specified output.
Too high an output, for example, in the case of surgical diathermy
units, would clearly be hazardous. Equally, too low an output would
result in inadequate therapy, which in turn may delay patient
recovery, cause patient injury or even death.
This highlights the importance of correct
calibration procedures.
12. 12
Medical equipment that has been
inadequately decontaminated after use
may cause infection through the
transmission of microorganisms to any
person who subsequently comes into
contact with it.
Clearly, patients, nursing staff
and service personnel are potentially at
risk here.
13. Microbes can be carried from one person to another on
the surface of any equipment that is shared between
them unless it is decontaminated between use.
Decontamination of medical equipment involves the
destruction or removal of any organisms present in order to
prevent them infecting other patients or hospital staff.
The process by which microbes are passed from one infected
person, to cause infection in another, is known as 'cross-
infection'. Decontamination reduces the risks of cross
infection and helps to maintain the useful life of equipment.
13
14. Cleaning, disinfection and sterilization are all procedures
that are used in the decontamination process.
Cleaning is the process that removes contaminants
including dust, soil, large numbers of micro -organisms
and organic matter
(e.g. blood, vomit).
It is an essential prerequisite to disinfection and
sterilization.
It also removes the organic matter on which micro-
organisms might subsequently thrive.
15. Disinfection is a process used to reduce the
number of micro-organisms but not usually
bacterial spores.
The process does not necessarily kill or
remove all micro-organisms, but reduces
their number to a level which is not harmful
to health.
Sterilization removes or destroys all forms
of microbial life including bacterial spores.
19. Risk Application of Item Recommendation
High
In close contact with broken skin
or mucous membrane
Introduced into sterile body
areas
Cleaning followed by sterilisation.
Irradiation (Gamma or E-Beam)
Ethylene Oxide
Steam Sterilization
Dry Heat Sterilization
Medium
In contact with mucous
membranes contaminated with
particularly virulent or readily
transmissible organisms
Prior to use on
immunocompromised patients
Cleaning followed by sterilization or disinfection
required. Where sterilization may damage equipment,
cleaning followed by high level disinfection may be
used as an alternative.
Sodium Hypochlorite (Bleach)
Ethyl Alcohol
Isopropyl Alcohol (70%)
Alconox, Liquinox
Cidex (Glutaraldehyde)
Low In contact with healthy skin
Not in contact with patient
Cleaning only
with a detergent and water
19
20. Following use on a patient or when requiring inspection or service, all
medical devices must be checked for visible evidence of contamination by
the user/clinician; however, as contamination is not always visible, all
equipment must be cleaned following patient use. Every attempt must be
made by the user to adequately decontaminate the equipment prior to
transfer for repair or servicing. If it is not possible to decontaminate, then
the equipment must be safely contained and clearly identified as
‘contaminated’ until advice is obtained from the Infection Prevention and
Control Team and the Medical Electronics Department.
All equipment MUST be accompanied by the Trust Declaration of
Decontamination Status of Healthcare Equipment Following Use and Prior to
Service or Repair form,
20
21. If items are dispatched to suppliers, or presented for service or
inspection on the hospital’s premises without a declaration of
decontamination, the receiver will refuse to accept the item and it
will be returned to the ward/department until it is accompanied by
the aforementioned form. In some instances total decontamination
may not be possible at source i.e. point of use, due to internal
contamination of the equipment, requiring additional tools to gain
access to the affected parts. The equipment must be removed to a
suitable designated area for appropriate decontamination prior to
inspection, service or repair. In this instance, the nature of
contamination must be clearly communicated to the receiving
organisation using the Trust Declaration of Decontamination Status
of Healthcare Equipment Following Patient Use and Prior to Service
or Repair form.
21
22. In particular situations, for example when an item
of equipment has been involved in an incident, its
condition may be altered or influenced by the
decontamination process. In such situations, advice
must be sought from those investigating the
incident, the Infection Prevention and Control Team
and Medical Electronics.
22
23. Any packaging must be sufficiently robust to withstand transport
and if possible packaging specifically designed for the item of
equipment must be used in accordance with the Carriage of
Dangerous Goods Regulations 2007.
The condition of the item must be clearly labelled indicating
content and contamination status. This is so that it can be clearly
determined prior to opening the package. E.g. biohazard label if
required and Trust Declaration of Decontamination Status of
Healthcare Equipment Following Patient Use and Prior to Service or
Repair form. Transport of contaminated equipment within the Trust
must be in a suitable container via internal hospital transport.
Where appropriate all external parts of large items of mobile
equipment should be covered in orange clinical waste bags and
suitably labelled.
23
24. Standard/process/
issue
Monitoring and audit
Method By Committee Frequenc
y
Correct completion
of Declaration of
Decontamination
Status of Healthcare
Equipment
Following Patient
Use and Prior to
Service or Repair
form
Audit Medical
Technology
Department
Hospital
Decontamination
Group
Annually
24
26. 26
Misuse of equipment is one of the most common
causes of adverse incidents involving medical
devices.
Such misuse may be a result of inadequate user
training or of poor user instructions.
Do not modify or alter devices, unless in the
instructions for use it is clear that the manufacturer
sanctions the modification or alteration.
27. 27
All electrical equipment has the potential to expose people to the risk of spurious
electric currents. In the case of medical electrical equipment, the risk is potentially
greater since patients are intentionally connected to such equipment and may not
benefit from the same natural protection factors that apply to people in other
circumstances. Whilst all of the hazards listed are important, the prevention of many
of them require methods peculiar to the particular type of equipment under
consideration. For example, in order to avoid the risk of excessive output of
surgical diathermy units, knowledge of radio frequency power measurement
techniques is required. However, the electrical hazards are common to all types of
medical electrical equipment and can minimized by the use of safety testing
regimes which can be applied to all types of medical electrical equipment.
For these reasons, it is the electrical hazards that
are the main topic of this session.
28. 28
The medical use of ionizing radiations, whether for diagnosis
or therapy, not only results in the irradiation of the patient but
may also result in some degree of exposure of radiologists,
radiographers, other workers of the department.
Although many patients benefit from radiation’s ability to
destroy cancer cells or capture real-time images of the
human body, radiation can harm healthy cells wherever it
enters the body. It is well documented that ionizing radiation
can cause damage ranging from uncontrollable cell
replication to cell death.
29. Ionizing Radiation
A radiation that has
sufficient energy to
remove electrons from
atoms or molecules as it
passes through matter.
Examples: x-rays,
gamma rays, beta
particles, and alpha
particles
Non-Ionizing Radiation
A radiation that is not as
energetic as ionizing
radiation and cannot
remove electrons from
atoms or molecules.
Examples: light, lasers,
heat, microwaves, and
radar
31. Whole Body 5,000 mrem/year
Lens of the eye 15,000 mrem/year
Extremities, skin, and
individual tissues
50,000 mrem per year
Minors 500 mrem per year (10%)
Embryo/fetus* 500 mrem per 9 months
General Public 100 mrem per year
* Declared Pregnant Woman
32.
33. Radiation has the power to both save and harm lives.
Radiologic technologists use radiation to provide
quality medical imaging, but they must be aware of
potential exposure to radiation’s detrimental effects.
When proper time, distance, and shielding techniques
are used, dangerous exposure levels can be avoided.
Protection techniques are even more important for a
pregnant radiologic technologist, who must safeguard
her fetus from exposure. With an employer’s
cooperation and appropriate protection in place, a
pregnant technologist should be able to work in a
radiology setting without harming her fetus.
34.
35. Minimize the amount of
time spent near sources
of radiation.
The exposure is to be
kept as short as
possible because the
exposure is directly
proportional to time.
36. Distance from the radiation
source should be kept as
great as possible
As the distance from a radioactive
source doubles,
the exposure rate decreases by a factor
of four (inverse square Law)
Physical Law:
◦ Inverse Square Law
37. A lead protective shield
is placed between the
x-ray tube and the
individuals exposed,
absorbing unnecessary
radiation
TECHNOLOGIST . 25 mm LEAD
LEAD APRON, GLOVES
THYROID SHIELD, GLASSES
PATIENT –
GONAD SHEILDING
. 5 mm LEAD
38. 38
Why Test & Calibration
What you cannot measure you cannot control
As components age and equipment undergoes changes in
temperature or humidity or sustains mechanical stress,
performance gradually degrades. This is called drift.
When this happens your test results become unreliable and
both design and performance quality suffer.
While drift cannot be eliminated, it can be detected and either
corrected or compensated for through the process of
calibration.
39. 39
Definitions
• Calibration: process of comparing an unknown against
a reference standard within defined limits, accuracies and
Uncertainties
• Verification: process of comparing an unknown against
a reference standard at usually one data point
40. 40
What to TEST for?
• Performance Testing
• Safety Testing
Electrical Safety Testing
Radiation safety Testing
•On newly acquired equipment prior to use
•During routine planned preventative Maintenance.
•After repairs have been carried out on equipment.
When to test
42. 42
Performance testing is the process of determining or ensuring that the
equipment is performing to the expected standards of accuracy,
reliability, free of hysteresis and linear (as designed).
Safe and effective devices need to be available for patient care , to meet
the regulations, accreditation requirements and standards
The goal of any medical equipment maintenance program is to
ensure that medical equipment is safe, accurate, and ready for
patient use
Medical equipment testing is a critical task to ensure medical
devices are performing correctly for patients, doctors, nurses and
technologists alike. In order to ensure that we use proper Test
Equipments to analyze the functioning of each
equipments
43. 43
These test devices are used to create signals and capture
responses from electronic Devices Under Test (DUTs).
The proper operation of the DUT can be proven or faults in the
device can be traced, repaired, and certified calibration.
In order to increase patient safety and reducing the risks of legal
liabilities (in case of a patient mishap or accident shown to be the
investigative cause due to faulty or un-calibrated test equipment.)
These testing devices must be calibrated Periodically traceable to
the National Institute of Science and Technology (NIST), National
Metrology Institute (NMI), and comply with international standards (
i.e. ISO 9001:2008 registered, ISO/IEC 17025:2005 accredited, and
ANSI/NCSL Z-540.1-1994 compliant.).
44. 44
Defibrillator Analyzer
Patient Simulator
Tachometer
ESU analyzer
Ultrasound Phantom
Phototherapy Radiometer
Electrical Safety Analyzer
Ventilator analyzer
Flow meter
O2 Analyzer
Digital Thermometer
Multi meter
BP Simulator
SPO2 Analyzer./Simulator
Infusion Pump Analyzer
pH meter
Test Lung
Spectrum Analyzer
KV & Dose meter
Pressure Meter
45. 45
Defibrillator testers are testing devices used in
performing output measurement tests and
performance verification on defibrillator
equipment. Mostly, these multifaceted devices
performs primary measurement of energy,
peak voltage, peak current, pulse width, and
charge time tests.
Also, the device performs cardioversion analysis, Output Energy
Measurement (in Joules), On-demand Pacemaker Testing, and
generates simulated performance waves used in defibrillator testing as
well as several additional tests. Lastly, technicians can store, print data,
or possibly transfer it to an automated computerized maintainence
management system for archival.
46. 46
Patient Simulators (also known as ECG
testers or "Chicken-Hearts") are testing
devices used in performing output
measurement tests and performance
verification on electrocardiograph and/or
defibrillator equipment. Mostly, these
multifaceted devices performs primary
measurements of a twelve-lead ECGs
performance waves (e.g. heartrates, NSR
w/ PVCs, V-Tachycardia, V-Fibrillation,
Asystole, Bigeminy, Pacer, Trigeminy,
ST+, Block, Square Waves), Respiration,
Invasive Blood Pressure, Cardiac Output ,
and Temperature measurements.
Lastly, technicians can store, print
data, or possibly transfer it to an
automated computerized
maintenance management
system for archival
47. 47
Blood Pressure simulators are testing
devices used in performing output
measurement tests and performance
verification on blood pressure, vital
signs, or physiological monitoring
equipment. Mostly, these multifaceted
devices performs primary measurements
of Auscultatory Non-Invasive Blood
Pressure (NIBP) performance waves
(e.g. adult and infant blood pressure
Waves), leak tests, over-pressure tests,
inflate or deflate times, systolic and
diastolic pressures, manometer
readouts, heart-rate measurements.
Lastly, technicians can store, print
data, or possibly transfer it to an
automated computerized maintenance
management system for archival
48. 48
Electrosurgical Unit (ESU) testers are
testing devices used in performing output
measurement tests and performance
verification on electrosurgical or Bovie
equipment. Mostly, these multifaceted
devices performs primary measurement of
energy, Load Impedance (50 Ohms), peak-
to-peak voltage, crest factor, selected load
impedance value, RF current, and RF
power tests. Also, RF Leakage tests,
including active and dispersive electrode
leakage to ground used in electrosurgical
testing as well as several additional tests.
The technicians can store, print
data, or possibly transfer it to an
automated computerized
maintenance management
system for archival
49. 49
Conductivity meters are testing devices
used in performing output conductivity
measurements (in µS/cm)and performance
verification for laboratory equipment in a
solution. Commonly used in hydroponics,
aquaculture and freshwater systems to
monitor the amount of nutrients, salts or
impurities in the water. Lastly, technicians
can store, print data, or possibly transfer it
to an automated computerized
maintenance management system for
archival.
50. 50
A digital voltmeter (DMM) is an
instrument used for measuring the
electrical potential difference between
two points in an electric circuit. Analog
voltmeters move a pointer across a scale
in proportion to the voltage of the circuit;
digital voltmeters give a numerical
display of voltage by use of an analog to
digital converter.
A multimeter can be a hand-held device useful for basic fault finding and field
service work or a bench instrument which can measure to a very high degree of
accuracy. They can be used to troubleshoot electrical problems in a wide array of
industrial and household devices such as electronic equipment, motor controls,
domestic appliances, power supplies, and wiring systems.
51. 51
Infusion pump testers are testing
devices used in performing output
measurement tests and performance
verification on infusion pumps, syringe
pumps, Patient Controlled Analgesia
(PCA) Pumps, and infusion controller
equipment. Mostly, these multifaceted
devices performs primary
measurements of Average Flow Rates,
Bolus, and Total Volume Delivered and
Timing measurements, Occlusion and
Back Pressure, and generates simulated
performance waves used in infusion
testing as well as several additional
tests.
Technicians can store, print data,
or possibly transfer it to an
automated computerized
maintainence management
system for archiva
52. 52
An Ultrasound Watt-meter
(Radiometer) are testing devices used
in performing output measurement
tests and performance verification on
ultrasound equipment. Mostly, these
multifaceted devices performs primary
measurements of total-pulsed or
continuous-average power (in watts)
measurements.
These devices are tested using either
demonized/distilled and/or degassed
water (never use regular tap water for
performing measurement checks--will
result in inaccurate readings). l. Lastly, technicians can store, print data, or
possibly transfer it to an automated
computerized maintainence management
system for archival.
53. 53
A Pulse Oximeter (SpO2)
testers are testing devices
used in performing output
measurement tests and
performance verification on
pulse oximeter equipment.
Mostly, these Multifaceted
devices performs primary
measurement of Rate,
Saturation Percentage, and
Pulse Amplitude.
Technicians can store, print data, or possibly transfer it to an
automated computerized maintainence management system for
archival.
54. 54
A ventilator testers are testing devices
used in performing output measurement
tests and performance verification on
insufflators, medical gas and vacuum
outlets, pressure gauges, flow-meters,
aspirators and suction devices, and
anesthesia equipment. Mostly, these
multifaceted devices performs primary
measurement of high- or low-flow and
pressure, Air, O2, CO2, N2, N2O, He
measurements, Breath rate (in breaths
per minute (bpm)), Inspiratory time,
Expiratory time, Positive end-expiratory
pressure (PEEP), Mean airway pressure
(in CM H2O), and Flow (in liters per
minute (lpm)) tests
Technicians can store, print data, or
possibly transfer it to an automated
computerized maintainence
management system for archival.
FlowAnalyser™ PF-300 ventilator tester
55. 55
Phototherapy Radiometer is designed for the accurate
measurement of light radiation in the blue part of the
spectrum from 400-480 nanometers. Phototherapy
exposure in this range is used in the treatment of
hyperbilirubinemia in newborn children.
It provides continuous measurement of irradiation by
simply placing the detection probe under the
phototherapy light (fluorescent lamps only). In addition
to verifying output power, the DALE40 saves costs by
eliminating premature replacement of lamps.
Light measurement is according to the percent
response given the wavelength characteristics curve.
The detector probe, included with the unit, has a wide
angle lens which matches the cosine receiving function
of human skin.
Measurements are taken in
µW/cm2, with a range of 0-1999.
This unit of measurement can
be compared directly to other
units of measurement.
56. 56
A Pressure Meter are testing devices used
in performing output measurement tests
and performance verification on
Ophthalmology lasers, dialysis machines,
automatic tourniquets, drainage devices,
IV pumps, diagnostic and surgical suction
devices, ventilators, and pressure gauges
equipment. Mostly, these multifaceted
devices performs primary measurement
of gas or liquid pressures Measurement
(in mmhg or cmH2O) as well as several
additional tests.
Technicians can store, print data,
or possibly transfer it to an
automated computerized
maintainence management
system for archival
57. 57
A spectrum analyzer are testing devices
used in performing output measurement
tests and performance verification on audio
and telemetry devices. Mostly, these
multifaceted devices performs primary
measurement of EMC/EMI, Frequency
Range, Bandwidth, Average Noise Level,
Sweep Time, and Amplitude tests. There are
analog and digital spectrum analyzers:
An analog spectrum analyzer uses either a
variable band-pass filter whose mid-
frequency is automatically tuned (shifted,
swept) through the range of frequencies of
which the spectrum is to be measured or a
superheterodyne receiver where the local
oscillator is swept through a range of
frequencies.
A digital spectrum analyzer computes the
discrete Fourier transform (DFT), a
mathematical process that transforms a
waveform into the components of its
frequency spectrum.
Some spectrum analyzers (such as "real-time
spectrum analyzers") use a hybrid technique
where the incoming signal is first down-
converted to a lower frequency using
superheterodyne techniques and then
analyzed using fast fourier transformation
(FFT) techniques.
58. 58
The thermometer is a device that
measures temperature or
temperature gradient using a variety
of different principles.
Thermometers that include an
electronic device and attached
sensors that detect and transduce
changes in temperature into
variations of some electric
characteristic (e.g., resistance,
voltage). These variations of the
electric characteristics are
processed in electronic circuits and,
in turn, displayed as temperature
readings.
Thermo meter
59. 59
The probe is designed using the latest
advances in micro system technology
and provides a complete in line real
time monitoring system with unique
versatility and design. The sensor
proves his reliability when testing the
performance of any anesthesia
delivery and monitoring systems or the
accuracy of CO2 monitoring devices.
The MultiGasAnalyser™ sensor head
measures infrared light absorption at
several different wavelengths and
exactly determines the gas
concentrations of the
mixtures.
60. 60
PH meter
A device used to measure the pH of a liquid
PH meter
Test Lung
A device used to check the function of ventilator
Infant Test Lung
Test Lung
Tacho meter
A device that measures
speed of rotation
Tacho meter
61. 61
The Firefly endoscope-testing device is a
handheld instrument designed to measure the
luminous radiation of standard medical
endoscopic light sources, fiber optic cables
and endoscopes.
The Firefly consists of an integrating sphere,
light meter and adapters to interface with
endoscopic equipment common in surgical
applications
Firefly
The Oxygen Analysers are used to measure
the concentration of the oxygen in a gas
sample
Oxygen Analyzer
62. 62
An electrical-safety testers are testing
devices used in performing safety tests
and performance verification on
medical equipment. Mostly, these
multifaceted devices performs primary
electrical safety tests, including mains
voltage, protective earth resistance,
insulation resistance, device current,
earth, chassis, and patient leakages,
lead-to-lead leakage, generates
simulated performance waves used in
defibrillator testing as well as several
additional tests.
technicians can store, print data, or
possibly transfer it to an automated
computerized maintainence
management system for archival.
63. 63
Digital kV Meter is a test device for quality
control and acceptance testing in
radiographic, mammographic, CT,
fluoroscopic and dental x-ray systems. It
enables the user to measure the new IEC
quantity "practical peak voltage" as well as
non-invasive kVp, relative mAs and
exposure time
Dosimeters measure an individual's or an
object's[ exposure to something in the
environment radiation dosimeter, which
measures exposure to ionizing radiation
65. 65
√ Ensure patient safety
Protect against macroshock
Protect against microshock
√ Test for electrical internal breakdown /
damage to power cord, AC mains
feed, etc.
√ Meet codes & standards
AAMI, IEC, UL, NFPA, etc.
√ Protect against legal liability
In case of a patient incident
67. 67
The International Electrotechnical
commission[1] (IEC) is a non-profit, non-
governmental international standards
organization that prepares and publishes
International Standards for all electrical,
electronic and related technologies –
collectively known as "electrotechnology".
IEC standards cover a vast range of technologies from power generation,
transmission and distribution to home appliances and office equipment,
semiconductors, fibre optics, batteries, solar energy, nanotechnology and marine
energy as well as many others.
The IEC also manages three global conformity assessment systems that certify
whether equipment, system or components conform to its International Standards.
68. 68
They also first proposed a system of standards, the Giorgi System,
which ultimately became the SI, or Système International d’unités
(in English, the International System of Units).
Today, the IEC is the world's leading
international organization in its field, and
its standards are adopted as national
standards by its members. The work is
done by some 10 000 electrical and
electronics experts from industry,
government, academia, test labs and
others with an interest in the subject.
69. 69
The IEC cooperates closely with the International
Organization for Standardization (ISO) and the
International Telecommunication Union (ITU). In
addition, it works with several major standards
development organizations, including the IEEE with
which it signed a cooperation agreement in 2002, which
was amended in 2008 to include joint development
work.
Other standards developed in cooperation between IEC
and ISO are assigned numbers in the 80000 series, such
as IEC 82045-1.
70. 70
IEC standards have numbers in the range 60000–79999 and their titles
take a form such as IEC 60417: Graphical symbols for use on equipment.
The numbers of older IEC standards were converted in 1997 by adding
60000, for example IEC 27 became IEC 60027.
IEC 60027 Letter symbols to be used in electrical technology...
IEC 60034 Rotating electrical machinery
IEC 60038 IEC Standard Voltages
IEC 60044 Instrument transformers
IEC 60050 International Electrotechnical Vocabulary
IEC 60062 Marking codes for resistors and capacitors
IEC 60063 Preferred number series for resistors and capacitors
IEC 60065 Audio, video and similar electronic apparatus - Safety requirements
IEC 60068 Environmental Testing
IEC 60071 Insulation Co-ordination
IEC 60073 Basic Safety principles for man-machine interface, marking and
identification
71. 71
IEC 60601 Medical Electrical Equipment
IEC 62304 Medical Device Software - Software Life Cycle Processes
IEC 62366 Medical devices—Application of usability engineering to medical
devices
IEC 62464 Magnetic resonance equipment for medical imaging
– the IEC 60601-1-xx series of collateral standards for MEDICAL
ELECTRICAL EQUIPMENT;
– the IEC 60601-2-xx series of particular standards for particular types of
MEDICAL ELECTRICAL EQUIPMENT; and
– the IEC 60601-3-xx series of performance standards for particular types of
MEDICAL ELECTRICAL EQUIPMENT
IEC 60601-x-xx
72. 72
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General
requirements for safety Collateral standard: Electromagnetic
compatibility – Requirements and tests
IEC 60601-1-3, Medical electrical equipment – Part 1: General
requirements for safety – 3. Collateral standard: General
requirements for radiation protection in diagnostic X-ray
equipment
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General
requirements for safety Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment – Part 1-8: General
requirements for safety Collateral standard: General requirements,
tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
73. 73
Electrolysis (mainly near d.c.)
Neuromuscular effects (mainly 10-100Hz)
Heating (mainly 100KHz-30Mhz)
Physiological Effects of Electricity
Human body can easily bear electrical current of 1 milliampere passing through its body
without appreciable risk or damage. However, as the amount of current increases the
body may suffer different type of damages like. Fibrillation, Burns to parts of the body
due to heat generated by electricity, Damage to nervous system causing loss of
nervous control.
When the current passes through brain it can lead to unconsciousness and permanent
damage to the brain. including death or electrocution
The physiological effects of electrical shock include the following.
74. 74
The human body can easily detect macro shock and violent
reactions occur to high current flow level in the body…
Below 1 ma (1,000 µa), it is often much more difficult to detect
the presence of a shock hazard from simple perception…
75. 75
The movement of ions of opposite polarities in
opposite directions through a medium is called
electrolysis and can be made to occur by passing
DC current through body tissues or fluids.
If a DC current is passed through body tissues for
a period of minutes, ulceration begins to occur.
Such ulcers, while not normally fatal, can be
painful and take long periods to heal.
76. 76
Na+ Na+ Na+
Cl- Cl- Cl-
_ +
Sodium atoms
created at electrode
Chlorine atoms
created at electrode
Ionic Current
The formation of
sodium atoms at the
negative electrode
and chlorine atoms
at the positive
electrode causes
local chemic al
actions which kills
the cells.
Electrolysis
Physiological Effects of Electricity
77. 77
Macro shock: is the most common type of shock received and occurs when the
human body becomes a conductor of electric current passing by means other than directly
through the heart. This effect can readly occur with the use of medical electrical equipment
as the natural resistance of the skin to current flow is often reduced or bypassed by
electrodes and electorde paste or by invasion into mucous membrane.
Large current passing through the skin - a small proportion may pass through the
heart
Macroshock has the potential for both burns and cardiac arrhythmias. Currents pass
through the extremities mostly through the muscles. A current flowing from arm to arm, or
arm to leg, must pass through the thorax. In the thorax the current is split between the
chest wall and the great vessels, which obviously deliver the current directly to the
myocardium.
Physiological Effects of Electricity
78. 78
Microshock refers to currents delivered
directly to the heart via intracardiac
electrodes or catheters. Because the current is
delivered to a very small area, only a very
small current is required to reach the
fibrillation threshold.
The currently accepted minimum current is 10
A (microamps = 1/1000 of milliamps
For a (15-100Hz) current passing between the hands, the following effects are
expected
0.5-1mA Perception
10mA Can’t let go
100mA Severe pain. Interference with breathing and heart
function
1A Sustained heart contraction
79. 79
Heating Effects - Surgical Diathermy
In Surgical Diathermy the heat is concentrated at the tip of the probe because the
current density (A/m2) is very high but at the plate it is low. Heating will occur at the
plate if he contact area reduces (plate comes loose)
Skin Internal Skin
Current = I
Low current
density at
return
electrode
Current = I
Very high
current density
at active
electrode
Physiological Effects of Electricity
80. 80
Classes and Types
L1 - Hot
L2 - Neutral
Earth - Ground
Mains Line - Voltage
Applied Parts - Patient
Leads
Enclosure/Case - Chassis
Protective Earth -Ground Wire
Earth Leakage Current
Leakage in Ground Wire
Enclosure Leakage - Chassis
Leakage
Patient Leakage - Lead Leakage
Patient Auxiliary - Leakage
between Patient Leads
Mains on Applied Parts - Lead
Isolation
Insulation Resistance - Dielectric
Strength or Insulation Resistance
between Hot and Neutral to
Ground
Earth Resistance - Ground Wire
Resistance
81. 81
All electrical equipment is categorised into classes
according to the method of protection against electric
shock that is used. For mains powered electrical
equipment there are usually two levels of protection
used, called "basic" and "supplementary" protection.
The supplementary protection is intended to come into
play in the event of failure of the basic protection.
Equipment Class{I,II,III} method of protection
against electric shock
Equipment Type{B,BF,CF} degree of protection
82. 82
Class I equipment has a protective earth. The basic means of protection is the
insulation between live parts and exposed conductive parts such as the metal
enclosure. In the event of a fault that would otherwise cause an exposed conductive
part to become live, the supplementary protection (i.e. the protective earth) comes
into effect. A large fault current flows from the mains part to earth via the protective
earth conductor, which causes a protective device (usually a fuse) in the mains circuit
to disconnect the equipment from the supply.
It is important to realise that not all equipment having an earth connection is
necessarily class I. The earth conductor may be for functional purposes only such as
screening. In this case the size of the conductor may not be large enough to safely
carry a fault current that would flow in the event of a mains short to earth for the
length of time required for the fuse to disconnect the supply.
term referring to electrical equipment in which protection against
electric shock does not rely on BASIC INSULATION only, but
which includes an additional safety precaution in that means are
provided for ACCESSIBLE PARTS of metal or internal parts of
metal to be PROTECTIVELY EARTHED
83. 83
Class I medical electrical equipment should have fuses at the equipment end of the
mains supply lead in both the live and neutral conductors, so that the
supplementary protection is operative when the equipment is connected to an
incorrectly wired socket outlet.
Further confusion can arise due to the use of plastic laminates for finishing
equipment. A case that appears to be plastic does not necessarily indicate that the
equipment is not class I. There is no agreed symbol in use to indicate that
equipment is class I.
Where any doubt exists, reference should be made to equipment manuals. The
symbols below may be seen on medical electrical equipment adjacent to terminals.
84. 84
The method of protection against electric shock in the case of class II
equipment is either double insulation or reinforced insulation. In double
insulated equipment the basic protection is afforded by the first layer of
insulation. If the basic protection fails then supplementary protection is
provided by a second layer of insulation preventing contact with live parts.
Reinforced insulation is defined in standards as being a single layer of
insulation offering the same degree of protection as double insulation.
Class II medical electrical equipment should be fused at the equipment
end of the supply lead in either mains conductor or in both conductors if
the equipment has a functional earth.
The symbol for class II equipment is two
concentric squares indicating double insulation
as shown.
85. 85
shock relies on the fact that no voltages higher than safety extra low voltage (SELV)
are present. SELV is defined in turn in the relevant standard as a voltage not
exceeding 25V ac or 60V dc.
In practice such equipment is either battery operated or supplied by a
SELV transformer.
If battery operated equipment is capable of being operated when connected to the
mains (for example, for battery charging) then it must be safety tested as either
class I or class II equipment. Similarly, equipment powered from a SELV transformer
should be tested in conjunction with the transformer as class I or class II equipment
as appropriate.
It is interesting to note that the current IEC standard relating to safety of
medical electrical equipment does not recognize Class III equipment since
limitation of voltage is not deemed sufficient to ensure safety of the patient. All
medical electrical equipment that is capable of mains connection must be classified
as class I or class II. Medical electrical equipment having no mains connection is
simply referred to as "internally powered
86. 86
As described above, the class of equipment defines the method of protection
against electric shock. The degree of protection for medical electrical equipment
is defined by the type designation. The reason for the existence of type
designations is that different pieces of medical electrical equipment have
different areas of application and therefore different electrical safety
requirements. For example, it would not be necessary to make a particular piece
medical electrical equipment safe enough for direct cardiac connection if there is
no possibility of this situation arising.
All medical electrical equipment should be marked by the manufacturer with
one of the type symbols.
Table below shows the symbols and definitions for each type classification of
medical electrical equipment.
87. 87
Type Symbol Definition
B
Equipment providing a particular degree of
protection against electric shock, particularly
regarding allowable leakage currents and reliability
of the protective earth connection (if present).
BF
As type B but with isolated or floating (F - type)
applied
part or parts.
CF
Equipment providing a higher degree of protection
against electric shock than type BF, particularly with
regard to allowable leakage currents, and having
floating applied parts.
Type Symbols for Medical equipments
88. 88
A part of the equipment which in normal use:
necessarily comes into physical contact withthe
patient for the equipment to perform its function;
or can be brought into contact with the patient;
or needs to be touched by the patient
tableNo applied part
89. 89
Part of equipment which can be touched without
the use of a tool.
EXAMPLE 1 Illuminated push-buttons
EXAMPLE 2 Indicator lamps
EXAMPLE 3 Recorder pens
EXAMPLE 4 Parts of plug-in modules
EXAMPLE 5 Batteries
90. 90
Current that is not functional.
several different leakage currents are defined according to the paths
that the currents take.
Earth Leakage Current
Enclosure Leakage Current
Patient Leakage Current
Patient auxiliary current
Causes of Leakage currents
If any conductor is raised to a potential above that of earth, some current is bound
to flow from that conductor to earth. The amount of current that flows depends on:
1- the voltage on the conductor.
2- the capacitive reactance between the conductor and earth.
3-the resistance between the conductor and earth.
91. 91
current flowing from the MAINS PART through or across the
insulation into the PROTECTIVE EARTH CONDUCTOR
Under normal conditions, a person who is
in contact with the earthed metal enclosure
of the equipment and with another earthed
object would suffer no adverse effects even
if a fairly large earth leakage current were
to flow. This is because the impedance to
earth from the enclosure is much lower
through the protective earth conductor than
it is through the person. However, if the
protective earth conductor becomes open
circuited, then the situation changes. Now,
if the impedance between the transformer
primary and the enclosure is of the same
order of magnitude as the impedance
between the enclosure and earth through
the person, a shock hazard exists.
92. 92
LEAKAGE CURRENT
flowing from the
ENCLOSURE to earth or
to another part of the
ENCLOSURE through a
conductor other than
the protective earth
conductor.
LEAKAGE CURRENT
flowing from the
ENCLOSURE to earth or
to another part of the
ENCLOSURE through a
conductor other than
the protective earth
conductor.
93. 93
Patient leakage current is
the leakage current that
flows through a patient
connected to an applied
part or parts.
It can either flow from the
applied parts via the
patient to earth or from an
external source of high
potential via the patient
and the applied parts to
earth.
Patient leakage current is
the leakage current that
flows through a patient
connected to an applied
part or parts.
It can either flow from
the applied parts via the
patient to earth or from
an external source of
high potential via the
patient and the applied
parts to earth.
94. 94
The patient auxiliary
current is defined as
the current that
normally flows between
parts of the applied
part through the
patient, which is not
intended to produce a
physiological effect
95. 95
By applying mains voltage to the applied parts, the leakage current that would flow
from an external source into the patient circuits can be measured.
Although the safety tester normally places a current limiting resistor in series with
the measuring device for the performance of this test, a shock hazard still exists.
Therefore, great care should be taken if the test is carried out in order to avoid the
hazard presented by applying mains voltage to the applied parts. Careful
consideration should be given as to the necessity or usefulness of performing this
test on a routine basis when weighed against the associated hazard and the
possibility of causing problems with equipment.
The purpose of the test under IEC 60601-1 is to ensure that there is no danger of
electric shock to a patient who for some unspecified reason is raised to a potential
above earth due to the connection of the applied parts of the equipment under test.
The standard requires that the leakage current limits specified are not exceeded.
There is no guarantee that equipment performance will not be adversely affected by
the performance of the test. In particular, caution should be exercised in the case of
sensitive physiological measurement equipment. In short, the test is a "type test".
96. 96
The resistance of the protective earth conductor is measured between the earth pin
on the mains plug and a protectively earthed point on the equipment enclosure (see
figure 6). The reading should not normally exceed 0.2 O at any such point. The test
is obviously only applicable to class I equipment.
In IEC60601, the test is conducted using a 50Hz current between 10A and 25A for a
period of at least 5 seconds. Although this is a type test, some medical equipment
safety testers mimic this method. Damage to equipment can occur if high currents
are passed to points that are not protectively earthed, for example, functional
earths. Great care should be taken when high current testers are used to ensure that
the probe is connected to a point that is intended to be protectively earthed.
HEI 95 and DB9801 Supplement 1 recommend that the test be carried out at a
current of 1A or less for the reason described above. Where the instrument used
does not do so automatically, the resistance of the test leads used should be
deducted from the reading.
If protective earth continuity is satisfactory then insulation tests can be performed.
97. 97
For a plugged-in system, it is worth doing a mains insulation test
on the system as a whole to check the integrity of the
interconnecting mains wiring and the MSO if fitted.
For installations, this test is impractical and may be dangerous. If
the test is to be performed, a number of preliminary steps are
required. The equipment / system must be disconnected from the
electrical supply. Allowance should be made for discharging large
capacitors, which may hold considerable charge for some time after
the machine is disconnected. Also any Uninterruptible Power
Supplies (UPS) must be identified and disconnected.
Electrical Safety Testing
98. Visual Inspection
Earth Resistance Test
Insulation Test
Leakage Current Test
Earth Leakage
Current
Touch Current Patient Leakage
Current
Electrical Safety Testing
100. 100
For systems, inspection should include ensuring that the system’s
components are all labelled and have all been tested individually during
acceptance testing. For routine testing, the tester should ensure that the
system has not been re-configured or items substituted.
For installations, visual inspection may include:
◦ Electrical works test certificates
◦ Electrical safety certificate for installations
◦ MEIGaN test certificate for sockets wiring, earth wiring and equipotential
bonding
◦ Review of suppliers’ EST
◦ Test certificates of other plug-in medical equipment or systems in the
patient area
Electrical Safety Testing
101. 101
The resistance of the protective earth conductor is
measured between the earth pin on the mains plug
and a protectively earthed point on the equipment
enclosure (see figure 6). The reading should not
normally exceed 0.2Ω at any such point. The test is
obviously only applicable to class I equipment.
In IEC60601, the test is conducted using a 50Hz
current between 10A and 25A for a period of at least
5 seconds. Although this is a type test, some medical
equipment safety testers mimic this method.
Damage to equipment can occur if high currents are
passed to points that are not protectively earthed, for
example, functional earths
Applicable to Class I, all types
Limit: 0.2Ω
DB9801 recommended?: Yes, at 1A or
less.
HEI 95 recommended?: Yes, at 1A or
less. Notes: Ensure probe is on a
protectively earthed point
105. 105
DUT 1
DUT 2
ERB
Incoming
PE Conductor
Bonding
Tester
Test to all exposed conductive
parts on each DUT in turn
< 0.1
< 0.2
Bonding
Tester
Installation
Electrical Safety Testing
106. 106
HEI 95 and DB9801 recommended that for
class I equipment the insulation resistance be
measured at the mains plug between the live
and neutral pins connected together and the
earth pin. Whereas HEI 95 recommended
using a 500V DC insulation tester, DB 9801
recommended the use of 350V DC as the test
voltage.
Applicable to Class I, all types
Limits: Not less than 50MΩ
DB9801 recommended?: Yes
HEI 95 recommended?: Yes
Notes: Equipment containing mineral
insulated heaters may give values down to
1MΩ. Check equipment is switched on
107. 107
HEI 95 further recommended for
class II equipment that the
insulation resistance be measured
between all applied parts
connected together and any
accessible conductive parts of the
equipment. The value should not
normally be less than 50MΩ
108. 108
Equipment Configuration Insulation Resistance
Stand alone >50 M
System without MSO >50 M
System with MSO >50 M
Permanently installed > 50 M
Electrical Safety Testing
110. 110
hygroscopic mineral-insulated heating elements, which may exhibit low values until run for
some hours to desiccate;
interference-suppression and discharge devices such as in Visual Display Units;
a compromise struck with competing requirements e.g. conductivity of operating theatre
electrical warming mattress.
For a plugged-in system, it is worth doing a mains insulation test on the system as a whole to
check the integrity of the interconnecting mains wiring and the MSO if fitted.
For installations, this test is impractical and may be dangerous. If the test is to be performed,
a number of preliminary steps are required. The equipment / system must be disconnected
from the electrical supply. Allowance should be made for discharging large capacitors, which
may hold considerable charge for some time after the machine is disconnected. Also any
Uninterruptible Power Supplies (UPS) must be identified and disconnected.
Equipment exhibiting values an order of magnitude lower may be permissible,
if they involve the following:
Electrical Safety Testing
111. 111
For class I equipment, earth leakage current is measured
as shown in figure 12. The current should be measured
with the mains polarity normal and reversed. HEI 95 and
DB9801 Supplement 1 recommend that the earth leakage
current be measured in normal condition (NC) only. Many
safety testers offer the opportunity to perform the test
under a single fault condition such as live or neutral
conductor open circuit
122. 122
An electrical-safety testers are testing
devices used in performing safety tests
and performance verification on
medical equipment. Mostly, these
multifaceted devices performs primary
electrical safety tests, including mains
voltage, protective earth resistance,
insulation resistance, device current,
earth, chassis, and patient leakages,
lead-to-lead leakage, generates
simulated performance waves used in
defibrillator testing as well as several
additional tests. technicians can store, print data, or
possibly transfer it to an automated
computerized maintainence
management system for archival.
123. 123
Electrical Safety Testing
Type of equipment User checks Formal visual inspection
Combined inspection and
test
Equipment loan or hire e.g. medical
equipment library, trial device
Visually inspect cable
and case
Before issue / after return According to category
MDD Risk Class I equipment
generally
Yes
On acceptance, after repair or
incident
If earthed, on acceptance, after
repair or incident
1 to 2 years
MDD Risk Class IIa; medium risk Yes 6 months to 1 year
1 to 2 years. Include leakage
currents tests
MDD Risk Class IIb; medium to high
risk
Yes 6 months to 1 year
6 months to 1 year or after repair
or incident. Include leakage
currents tests
MDD Risk Class III; high risk Yes 6 months to 1 year
6 months to 1 year or after repair
or incident. Include leakage
currents tests
Equipment used by the public, e.g. in
hotels, patients own equipment from
home
By member of staff 3 months When arrives or 1 year
Cables and plugs, extension leads Yes 6 months to 1 year (intrusive) 1 year
126. 126
The most advanced Electrical Safety Analyzer on the market
EN60601-1, EN601010-1, and AAMI & ESI test loads (user selectable) into one
device
The One-Touch-Testing user interface
Allows user to perform rapid tests on various medical devices
Multiple enclosure-leakage points
Multiple patient-applied-part types
• Power ON/OFF delay
• DC only for patient- and auxiliary-leakage tests
• User-programmable test sequences
• Offers manual, auto, step, and computer-control mode operations
• ASCII data transfer
• Memory for up to 1000 device-information records
• Conducts electrical safety testing in accordance with IEC 601-1, VDE 751, VDE
701, HEI 95, IEC 1010, AAMI, and AS/NZS 3551 requirements
601PROSeriesXL
127. 127
• Flags failures, and simulates
performance, ECG, and
arrhythmia, waveforms.
• Results automatically analyzed
and saved in non-volatile
memory
• Accepts device information
that is input using an
– External keyboard,
– Integrated keypad,
– Barcode keyboard wedge
Optional Feature
• Onboard thermal printing
601PROSeriesXL
128. 128
Voltage Range: 0 to 300 V True RMS (single and dual lead)
Accuracy: DC - 100 Hz ± 1.5 % of reading ± 1 LSD
Insulation
Resistance Range: 0.5 to 400.0 MΩ
Accuracy: ± 5 % of reading ± 2 LSD
Current
Consumption Range: 0 to 15 A ac True RMS
Accuracy: ± 5 % of reading ± 2 LSD
Mains on Applied
Part
Applied
Voltage:
≥ 110 % of mains voltage
Accuracy: ± 2 % of reading ± 6 µA
Protective Earth
Resistance Range: 0.000 to 2.999 Ω
Accuracy:
± 5 % of reading ± 4 mΩ (1 A, 10 A, and 25 A test currents)
(Refer to Operator’s Manual for additional specs qualifying the
effects on accuracy of variations in load inductance and phase
angle.)
Supply Voltage 90 to 265 Vac, auto switching
601PROSeriesXL
129. 129
601PROSeriesXL
IEC601-1 and AAMI
Leakage Currents
Range: 0 to 8000 µA True RMS
Accuracy:
(per IEC601-1 or AAMI filter),
-DC - 1 kHz ± 1 % of -reading ± 1 µA
-1 to 100 kHz ± 2 % of reading ± 1 µA
- 100 kHz to 1 MHz ± 5 % of reading ± 1 µA
DC-Only Frequency
Response:
DC - 5 Hz (approx)
ECG Simulation and
Performance Testing ECG Complex: 30, 60, 120, 180, 240 BPM
Performance
Pulse: 30, 60 BPM, 63 ms pulse width
600 to 700 µs rise and fall
time
Sine Waves: 10, 40, 50, 60, 100 Hz
Square Wave: 0.125, 2.000 Hz (50 % duty cycle)
Triangle Wave: 2 Hz, 2 mV
Dimensions 16.62 in L x 11.75 in W x 5.56 in H
Weight 17lb / 7.7kg
130. 130
Mains Voltage
Dual Lead Voltage
Dual Lead Leakage
Current Consumption
Insulation Resistance
Protective Earth
Resistance
Earth Leakage Current
Enclosure Leakage
Current
Patient Leakage
Current
Mains on Applied Part
Leakage
Patient Auxiliary Current
Accessible Voltage
Accessible Leakage
Equivalent Device
Leakage
Equivalent Patient
Leakage
601PROSeriesXL
131. 131
Probe/Safety Lead, Red - 1
Probe/Safety Lead, Black - 1
Adapter, Banana/Alligator - 5
Operators Manual - 1
Large Clamp, Red - 1
Warranty Card - 1
Printer Paper Roll (original) - 1
Printer Paper Roll (new style) - 1
• Carry Case
• RS232 Cable (9M-9F)
• Printer Cable
• Barcode, Keyboard, Wedge
• Adapter, Banana, ECG
• Keyboard English
• Powercord Set Australian
• Powercord Set Schuko
• Powercord Set US 120 V
• Powercord Set UK
601PROSeriesXL
Optional Accessories
132. 132
Keys grouped by color and functionality
Red keys -used to access menu options
◦ Include previous key, the four SOFT KEYS, and
the enter key
Black keys -gain access to additional functions
◦ Include the esc/stop key, the view present
settings key, the print header key, and the print
data key.
601PROSeriesXL
133. 133
1. Using Factory Default
Settings
2. Selecting the Test Standard
3. Selecting the Printer Output
4. Selecting the RS232 Baud
Rate
5. Activating the Beeper
6. Setting the Time and Date
7. Configuring the Enclosure
Leakage for the Auto mode
Sequence
8. Selecting Language Options
9. Selecting the DC Option
10. Selecting the Auto/Step Tests:
Controlled Power Sequences
or 601CE Conventional Test
11. Sequences enabling Stop on
Failure
12. Configuring for Device
Records or Templates
601PROSeriesXL
134. 134
1. Connecting the Device Under Test
2. The Power-Up Sequence
3. Selecting the Test Standard
4. Selecting the Class/Type
5. Saving Standard, Class, Type and Test Current
6. Using View Present Settings
7. Manual Operation
601PROSeriesXL
1. Selecting Auto or Step Mode Testing
2. Executing Auto and Step Mode Tests
3. Creating/Editing a Device Record or Template
Auto/Step Modes
135. 135
1. Sending Test Results from the 601PRO to the Host
2. Computer
3. Test Data Record: Serial Output
4. Printing Test Records
5. Deleting Test Records
601PROSeriesXL
1. Connecting the 601PRO and the Host
Computer
2. Sending Device Information Records from the
601PRO to the Host Computer
3. Receiving Device Information Records from
the Host computer
4. Device Information Record: Definition of
Fields
5. Device Information Record Format
6. Deleting Device Records and Templates
Device Records and Templates
136. 136
1. Permanently Wired Devices
2. Portable Devices
3. Portable Devices in Isolated Power Systems
4. Testing Three-Phase Portable Devices
5. Testing Conductive Surfaces
6. Detachable Power Supply Cable
7. Battery-Powered Equipment
601PROSeriesXL
1. Accessing System Setup
2. Selecting the Test Standard
3. Referring to Test Limits for the Selected Standard
Standards and Principles
138. 138
The risk of sustaining an electric shock can be
reduced by adopting the following practices:
1. A suitable Permit-to-Work system should always be in
place and operated, to ensure the effective isolation of hard-wired equipment before
repair or maintenance work commences.
1. Due care must always be exercised when switching off main power supplies to ensure
that only the intended circuits are isolated. Lock-off systems must be used, where
necessary.
2. Switch off and withdraw the plug on items of portable electrical equipment prior to
making any alterations or modifying any circuitry.
3. Do not handle any equipment with wet hands and do not work in close proximity to water
supplies or other earthed metalwork where there may be a risk of putting one hand on
earthed metal and the other on live equipment. If equipment is suspected of being live,
switch off, and have its electrical status tested by a competent person. Record the test.
139. 139
5. The external metal casing of electrical apparatus and associated cables and conduits must
be earthed as a legal requirement. Water and gas pipes, however, must not be used as
earth points. Such pipes must be effectively bonded, to ensure that they remain at an equal
electrical potential. Checks should be carried out at least annually, to ensure that this
continues to be the case.
6. On no account must a three-phase socket outlet be used to supply single-phase apparatus.
7. Where supplies to experimental equipment are obtained from terminals, these must be
insulated and a control/emergency switch must be close by.
8. Standard types of electrical fittings, such as 3-pin plugs, sockets and switches, should
always be used as specified by manufacturers and in accordance with good practice (e.g.
switches must not be mounted upside down and single pole switches must not be wired into
the neutral lead.)
9. If it is possible to do so, always use low voltage equipment.
10. The use of high voltage equipment must be strictly controlled, and suitable assessments of
risk, and control features, prepared prior to use.
140. 140
Typical Voltages at the Wall Socket
Note :the preferred method of
hand wiring plugs: Long earth
wire, short live
Electrical Hazards
142. 142
Leakage Current
In Class I equipment, most leakage current is caused by
capacitance between the leads in the mains cord and a
small amount due to stray capacitance within the equipment
itself.
Electrical Hazards
143. 143
If the earth lead becomes detached, then the current that
would normally have flowed along it will now be available
on the case of the equipment and, in the case of a Type
B applied part, it will also flow through the patient
Electrical Hazards
146. 146
Loss of Earth in Class 1 Equipment
This is the most common and most serious hazard since a
simple failure of basic insulation will then produce a deadly
situation of the metal case being at live mains voltage
Loss of earth will only be found by testing
MP
Class 1
Electrical Hazards
147. 147
Extension Leads
Extension leads are not permitted in clinical areas of RCH
organisations. They may cause high earth resistance and excessive earth
leakage current. An extension lead can allow equipment to be powered
from areas other than the relevant protected treatment area. The power
from the other area may not be protected to the same level as the power in
the treatment area.
As the connection between the extension lead and the equipment mains
cable is often on the floor there is a high danger from fluid spills, tripping
and damage to the mains cable by trolleys when an extension lead is used.
Double Adaptors
Double adaptors must not be used
in RCH organisations. They may not
sit securely in a wall outlet, may not
be able to provide adequate earth
protection and may cause overloading,
overheating, fire or loss of electrical supply
149. 149
IEC 60601 IEC XXXXXA/P
Functional
Connection
The medical equipment might draw large currents via the I/O
port which, under a SFC, could appear on the applied part
(Type B) or on the enclosure for Class I
Electrical Hazards
150. 150
IEC 60601
or XXXXX
IEC XXXXX
Functional
Connection
Earth with
potential
difference
Patient
Environment
In case of an interruption of protective earthing for an equipment in the
patient environment, this potential difference may appear on the
enclosure of the equipment causing a safety hazard for
the operator or for the patient
Electrical Hazards
151. 151
Humidity in the plugs of blood and fluid heaters
causing device failure (Andersen C, Pold R, Nielsen HD. Ugeskr
Laeger 2000; 162(6))
Accidental toppling of a fluid container causing spillage
onto a blood pressure monitor (Singleton RJ, Ludbrook GL,
Webb RK, Fox MA. Anaesth Intensive Care 1993; 21(5))
Electric shocks to anaesthetists after touching a faulty
device and the chassis of another device simultaneously
(Singleton RJ, Ludbrook GL, Webb RK, Fox MA. Anaesth Intensive
Care 1993; 21(5))
Electrical Hazards
152. 152
An anaesthetised patient was connected to an ECG device
that had been wired wrongly with the earth and neutral
connections transposed. After noticing electrical
interference with the ECG signal, the anaesthetist
instructed an assistant to plug the monitor into a 2nd wall
socket. Unknown to the assistant, the 2nd socket was
wired with reverse polarity causing the chassis of the
monitor to go live and suffered a minor shock.
Unfortunately the patient experienced an intense shock
since she was also connected to a surgical diathermy
plate. She became cyanotic and her pulse stopped but
later recovered completely (Atkin DH, Orkin LR. Anesthesiology
1973; 38(2))
Electrical Hazards
153. 153
A 9-month old baby was found dead on a bed after
admission to hospital with suspected pneumonia. The
patient apparently put an uncovered oval shaped lamp
switch (pendant switch) into his mouth and died of electric
shock after contacting the exposed wires (Yamazaki M, Bai H,
Tun Z, Ogura Y, Wakasugi C. J Forensic Sci 1997; 42(1))
Electrical Hazards