This document discusses various types of medical equipment testing devices used by biomedical engineers. It describes electrical safety analyzers that test for electrical safety standards, performance analyzers like defibrillator and infusion pump analyzers that test device performance, and simulators & controllers that simulate patient conditions to test equipment. Biomedical engineers work to ensure safety, effectiveness and reliability of medical technology through proper testing, repair and calibration of equipment.

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

5. 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

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

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

8. Why testing and calibration is
necessary?

9. Testing and Calibration

10. CLASSIFICATION OF LAB DEVICES

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

12. 1: ELECTRICAL SAFETY
TESTING
AND ANALYZERS

13. 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

14. 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

16. Effects of Electric
Current on Human
Body

17. 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

18.  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

19. 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

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

22. DEFIBRILLATOR ANALYZER

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

24. 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

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

26. Electrosurgery and ESU

27. 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.

28. 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.

29. 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

30. 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

31. 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

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

33. 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.

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

35. 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.

36. 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.

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

38. 199 X-RAY MEDICAL SCOPE METER
Displays kVp wave
forms and direct
kVp values
simultaneously on
an easy-to-read
screen

39. 3. Simulators & Controllers

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

41. 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

42. 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

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

44. 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

45. SP02 SIMULATORS
INDEX 2 PULSE OXIMETER SIMULATOR

46. 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.

47. OTHER DEVICES

48. VENTILATOR Ventilator analyzer

49. TEMPERATURE SIMULATOR

50. Who is responsible for that?

51. ANY QUESTION?