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University of central Punjab

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

The Reality of Life…

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

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.

BUT THANX TO BIOMEDICAL

ENGINEERING AND ADVANCE

TECHNOLOGY

BIOMEDICAL ENGINEERS

Who we are ?

What we do?

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

FOR THE HEALTH INDUSTRY ,

BE IT HOSPITALS OR

MANUFACTURES OF

MEDICAL EQUIPMENT-

NOTHING COUNTS MORE

THAN THE SAFETY OF

PATIENT.

Hence proper Testing , Repairing , and

Calibrations of medical Equipment's is

necessary

Why testing and calibration is

necessary?

Testing and Calibration

CLASSIFICATION OF LAB DEVICES

WE CAN DIVIDE LAB DEVICES IN TO

THREE TYPES:

1. Electrical Safety Analyzers

2. Performance Analyzers

3. Simulators & Controllers

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

PERFORMANCE ANALYZERS

Defibrillator analyzer

Electrosurgery

Infusion Device

Incubator

Pressure Meters

Gas-Flow

Oxygen Analyzers

Medical Scopemeters

SIMULATORS & CONTROLLERS

Multipara meter Patient Simulators

Non-Invasive Blood Pressure Simulators

Sp02 Simulators

Fetal Simulators

Controllers

1: ELECTRICAL SAFETY

TESTING

AND ANALYZERS

WHY CALIBRATION AND ELECTRICAL

SAFETY OF MEDICAL EQUIPMENT

Why Test & Calibration

What you cannot measure you cannot control

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.

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

ELECTRICAL SAFETY ANALYZER

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

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

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

STANDARD FEATURES

• Flags failures, and simulatesperformance, ECG, andarrhythmia, waveforms.

• Results automatically analyzedand saved in non-volatilememory

• Accepts device information that is input using an

– External keyboard,

– Integrated keypad,

– Barcode keyboard wedge

Optional Feature

• Onboard thermal printing

SPECIFICATIONSVoltage Range: 0 to 300 V True RMS (single and dual lead)

Accuracy: DC - 100 Hz ± 1.5 % of reading ± 1 LSD

Insulation

ResistanceRange: 0.5 to 400.0 MΩ

Accuracy: ± 5 % of reading ± 2 LSD

Current

ConsumptionRange: 0 to 15 A ac True RMS

Accuracy: ± 5 % of reading ± 2 LSD

Mains on Applied

PartApplied 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 Voltage90 to 265 Vac, auto switching

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

Effects of Electric

Current on Human

Body

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

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

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

PERFORMANCE ANALYZERS

Defibrillator analyzer

Electrosurgery

Infusion Device

Incubator

Pressure Meters

Gas-Flow

Oxygen Analyzers

Medical Scopemeters

DEFIBRILLATOR ANALYZER

To understand the cocept of defibrillator analyzer first we

must know :

What is defibrillation?

What is defibrillator?

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.

DEFIBRILLATOR

A device that reverse the

fibrillation of heart.

Fibrillation causes the

heart to stop pumping

blood, leading to brain

damage

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

STANDARD FEATURES

Mostly these multifaceted devises

performs

primary measurement of energy,

peak voltage,

peak current,

pulse width, and

charge time test

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.

Electrosurgery and ESU

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.

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.

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

ELECTROSURGERY UNIT TESTERMostly, 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

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

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

INCUBATORS

It is an enclosed apparatus

providing a controlled

environment for the care

and protection of premature

or unusually small babies.

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.

PRESSURE METERS

DPM2Plus Pressure Meter

DPM4 Parameter Tester

DPM1B Pneumatic Transducer

Tester

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.

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.

GAS FLOW ANALYZER

Bi-directional flow,

pressure, volume, and

oxygen concentration,

and pressure

measurements

Low- and high-pressure,

and flow measurement

capability

199 X-RAY MEDICAL SCOPE METER

Displays kVp wave

forms and direct

kVp values

simultaneously on

an easy-to-read

screen

3. Simulators & Controllers

SIMULATORS & CONTROLLERS

Multipara meter Patient Simulators

Non-Invasive Blood Pressure Simulators

Sp02 Simulators

Fetal Simulators

Controllers

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

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

NON-INVASIVE BLOOD PRESSURE

SIMULATORS

BP Pump 2 Non-Invasive

Blood Pressure Simulator

CuffLink Non-Invasive Blood

Pressure Simulator

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

SP02 SIMULATORSINDEX 2 PULSE OXIMETER SIMULATOR

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.

OTHER DEVICES

PULSE OXIMETER

ECG MACHINE AND SIMULATOR

VENTILATOR Ventilator analyzer

TEMPERATURE SIMULATOR

Who is responsible for that?

ANY QUESTION?