The document discusses the importance of electrical safety and performance analyzers in biomedical engineering, emphasizing the need for testing and calibration of medical equipment to ensure patient safety. It details various types of analyzers, such as electrical safety analyzers, performance analyzers, and simulators/controllers, while outlining their functions and testing standards. Additionally, it underscores the role of biomedical engineers in enhancing patient care and reducing risks associated with medical devices.

1. University of central Punjab
Tel #+923314947934

3. OBJECTIVE..
As a result of completing this module you should be
able to understand the:
The concept of :
 Electrical Safety Analyzers
 Performance Analyzers
 Simulators & Controllers

4. The Reality of Life…

5. "... hearts & brains too good to die."
Peter Safar, MD

6. Despite advances in medical science
Sudden Death continues to increase
Advances in modern medical science (including
Emergency Medical Services) have helped to prolong
life and reduce the number of deaths from many “killer”
health problems. But the problem of sudden cardiac
death has continued to go virtually unchecked.

7. BUT THANX TO BIOMEDICAL
ENGINEERING AND ADVANCE
TECHNOLOGY

8. BIOMEDICAL ENGINEERS
Who we are ?
What we do?

9. WHO WE ARE?
 Biomedical engineering is a team of
engineering professionals working in a
clinical environment to resolve technology
issues related to patient care
What we do?
 Biomedical engineers provide their services
by reducing the risks, improve patient
outcome and enhance patient care in a cost
effective manner

10. FOR THE HEALTH INDUSTRY ,
BE IT HOSPITALS OR
MANUFACTURES OF
MEDICAL EQUIPMENT-NOTHING
COUNTS MORE
THAN THE SAFETY OF
PATIENT.

11. Hence proper Testing , Repairing , and
Calibrations of medical Equipment's is
necessary

12. Why testing and calibration is
necessary?

13. Testing and Calibration

15. CLASSIFICATION OF LAB DEVICES

16. WE CAN DIVIDE LAB DEVICES IN TO
THREE TYPES:
1. Electrical Safety Analyzers
2. Performance Analyzers
3. Simulators & Controllers

17. ELECTRICAL SAFETY ANALYZERS
 ESA612 Electrical Safety
Analyzer »ESA620 Electrical Safety
Analyzer »ULT800 Ultrasound Transducer
 Leakage Current Tester » medTester 5000C
Automated Biomedical Equipment Test
 System
 180 Electrical Safety Analyzer
 175 Electrical Safety Analyzer

18. PERFORMANCE ANALYZERS
 Defibrillator analyzer
 Electrosurgery
 Infusion Device
 Incubator
 Pressure Meters
 Gas-Flow
 Oxygen Analyzers
 Medical Scopemeters

19. SIMULATORS & CONTROLLERS
 Multipara meter Patient Simulators
Non-Invasive Blood Pressure Simulators
Sp02 Simulators
 Fetal Simulators
Controllers

20. 1: ELECTRICAL SAFETY
TESTING
AND ANALYZERS

21. WHY CALIBRATION AND ELECTRICAL
SAFETY OF MEDICAL EQUIPMENT
Why Test & Calibration
What you cannot measure you cannot control

22. Electrical safety testing
It is essential to ensure safe
operating standards for any
product that uses electricity.
In most markets it is mandatory for
a product to conform
to safetystandards pro
mulgated by safety and standard
agencies such as
UL, CE, VDE, CSA, BSI, CCC and
so on.

23. ELECTRICAL SAFETY TESTS
To conform to such standards, the product must pass safety
tests such as the high voltage test (also called as Dielectric
voltage-withstand test or high potential test),
 Mains Voltage
 Dual Lead Voltage
 Dual Lead Leakage
 Current Consumption
 Insulation Resistance Test,
 Ground (Earth) Bond & Ground Continuity Test & Leakage
Current Test (also called as Line Leakage Test, Earth
Leakage Current Test,
 Enclosure Leakage Current Test or Patient Leakage Current
Test).
These tests are described in IEC 60335, IEC 61010 and many
other national and international standards

24. ELECTRICAL SAFETY ANALYZER

25. ELECTRICAL SAFETY ANALYZERS
 ESA612 Electrical Safety
 Analyzer »ESA620 Electrical
Safety
 Analyzer »ULT800
Ultrasound Transducer
 Leakage Current Tester »
medTester 5000C
 Automated Biomedical
Equipment Test
 180 Electrical Safety
Analyzer
 175 Electrical Safety
Analyzer

27. STANDARD FEATURES
 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

28. STANDARD FEATURES
• 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

29. STANDARD FEATURES
• 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

30. SPECIFICATIONS
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

31. 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

32. Effects of Electric
Current on Human
Body

33. Effects of Electric Current on Human
Body
•Threshold of perception of electric
shock is about 1mA
•Tingling sensation is felt when
contacted with electrified object
through intact of skin
•As magnitude of alternating current is
increased
– Tingling sensation leads to
contraction of muscles
– Muscular contraction increases
– Finally value of current is
reached where grip of current
cannot be released

34.  Let -go- current: the max. current at which the subject
is still capable of releasing a conductor by using
muscles
 Here individual can withstand with no serious effects
 Average let go current for males- 16mA, females-10.5mA,
approx. 9-6 mA for both.
Hold-on-type: A current level higher than let go
current, the subject looses ability to control his own
muscle action and unable to release grip on the
conductor
 Such currents are very painful and hard to bear
 Physical injury is caused b currents in range of 20-100mA
A very high currents (6 amperes and above) lead to
 Temporary respiratory paralysis
 Serious burns

35. Recommendations of IEC
International Electrotechnical
Commission (IEC) said:
 Continuous medical equipment current
should not exceed 100 uA
 Should be with in a frequency range of 0
to 1kHz
 In abnormal situations recommended
max. current is 500 uA
 Should be in a frequency upto 1 kHz
 Above 1 kHz max increases is
proportionally with frequency

37. PERFORMANCE ANALYZERS
 Defibrillator analyzer
 Electrosurgery
 Infusion Device
 Incubator
 Pressure Meters
 Gas-Flow
 Oxygen Analyzers
 Medical Scopemeters

38. DEFIBRILLATOR ANALYZER

39. To understand the cocept of defibrillator analyzer first we
must know :
What is defibrillation?
What is defibrillator?

40. DEFIBRILLATION
Defibrillation is a proses in which
an electronic devise sends an
electric shock to the heart to
stop an extremely rapid, irregular
heartbeat, and restore the
normal heart rhythm.

41. DEFIBRILLATOR
A device that reverse the
fibrillation of heart.
Fibrillation causes the
heart to stop pumping
blood, leading to brain
damage

42. DEFIBRILLATOR ANALYZER
Defibrillator testers are
testing devices used in
performing output
measurement tests and
performance verification
on defibrillator
equipment.
Defibrillator analyzers
automate the inspection
and preventive
maintenance testing of
defibrillators

43. STANDARD FEATURES
Mostly these multifaceted devises
performs
 primary measurement of energy,
 peak voltage,
 peak current,
 pulse width, and
 charge time test

44.  Also, the device performs cardio version 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 maintenance
management system for archival.

45. Electrosurgery and ESU

46. ELECTROSURGERY
Electrosurgery is the application of high frequency
electric current to biological tissue as a mean to
cut, coagulate, desiccate, or fulgurate (sparking
with the coagulation wave form) tissue.

47. BENEFITS
Its benefits include:
 The ability to make precise
cuts with limited blood loss.
 Electrosurgical devices are
frequently used during surgical
operations helping to prevent
blood loss in hospital
operating rooms or in
outpatient procedures.

48. ELECTROSURGERY UNIT (ESU)
A Electrosurgical Unit (ESU)
testers are testing devices used in
performing output measurement
tests and performance verification
on electrosurgical or Bovie
equipment

49. ELECTROSURGERY UNIT TESTER
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.
 RF Leakage tests, including active and dispersive
electrode leakage to ground used in electrosurgical
testing as well as several additional tests

50. INFUSION/SYRINGE PUMP ANALYZERS
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

51. STANDARD FEATURES
Mostly, these multifaceted devices
performs
 primary measurements of Average
Flow Rates,
 Bolus,
 Total Volume Delivered and Timing
measurements,
 Occlusion and Back Pressure,
 Generates simulated performance
waves used in infusion testing as well
as several additional tests

52. INCUBATORS
It is an enclosed apparatus
providing a controlled
environment for the care
and protection of premature
or unusually small babies.

53. INCU™ INCUBATOR ANALYZER
The INCU™ is an
incubator analyzer,
designed around AAMI
and IEC standards, that
specifies
• Temperature,
• Humidity,
• Sound and
• Airflow characteristics
of incubators.

54. PRESSURE METERS
DPM2Plus Pressure Meter
DPM4 Parameter Tester
DPM1B Pneumatic Transducer
Tester

55. DPM2Plus Pressure Meter
The DPM2Plus
Universal Pressure
Meter is designed to
measure the positive
and negative pressures
of medical devices in
either liquid or gaseous
form to assist in repair
and quality control.

56. DPM4 Parameter Tester
DPM4 is ideal for the
testing done as part of
preventive maintenance
or repair processes
whenever measurement
of pressure, flow, or
relative humidity is
required.

57. GAS FLOW ANALYZER
Bi-directional flow,
pressure, volume, and
oxygen concentration,
and pressure
measurements
Low- and high-pressure,
and flow measurement
capability

58. 199 X-RAY MEDICAL SCOPE METER
Displays kVp wave
forms and direct
kVp values
simultaneously on
an easy-to-read
screen

59. 3. Simulators & Controllers

60. SIMULATORS & CONTROLLERS
Multipara meter Patient Simulators
Non-Invasive Blood Pressure Simulators
Sp02 Simulators
Fetal Simulators
Controllers

61. MULTIPARAMETER PATIENT SIMULATORS
PS410 ECG/Arrythmia Simulator
 medSim 300B Patient Simulator
MPS450 Patient Simulator
Data Sim 6100 Patient Simulator
ECG Simulator, PS420 Multiparameter Patient ECG
Simulator

62. MPS450 PATIENT SIMULATOR
•ECG 12-lead simulation
•invasive BP
• respiration
• temperature
•BP in sync with ECG
•HHC3 HAND HELD
CONTROLLER is used to
remotely operate MPS450

63. NON-INVASIVE BLOOD PRESSURE
SIMULATORS
BP Pump 2 Non-Invasive
Blood Pressure Simulator
CuffLink Non-Invasive Blood
Pressure Simulator

64. BP PUMP 2 NON-INVASIVE BLOOD
PRESSURE SIMULATOR
 The BP Pump 2
provides dynamic blood-pressure
simulations for
testing adult and
neonatal noninvasive
blood pressure
monitors, including both
arm- and wrist-cuff
types. The analyzer
features a preset mode
for simulation of most
patient conditions and
the capability to
program user-defined
simulations

65. SP02 SIMULATORS
INDEX 2 PULSE OXIMETER SIMULATOR

66. DALE40 PHOTOTHERAPY
RADIOMETER
 The DALE40 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.
 The DALE40 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.

67. OTHER DEVICES

68. PULSE OXIMETER

69. ECG MACHINE AND SIMULATOR

70. VENTILATOR Ventilator analyzer

71. TEMPERATURE SIMULATOR

72. Who is responsible for that?

74. ANY QUESTION?