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Medical Equipment Calibration and Quality Assurance

Presentation · March 2014

DOI: 10.13140/RG.2.2.27148.31361

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Moustafa Mohamed Ahmed

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Medical Equipment Calibration
and Quality Assurance

Prof. Moustafa M. Mohamed

Vice Dean
Faculty of Allied Medical Science
Pharos University in Alexandria
 Lab’s Devices
We can divide Medical Equipment
Calibration devices in to three types:
1.Electrical Safety Analyzers
2.Performance Analyzers
3.Simulators & Controllers
Electrical Surgical Unit
Defibrillator
Pacemaker
Infusion/Syringe Pump
Incubator
Patient monitor
Pulse Oximeter
ECG Machine
•Pressure
•Humidity
•Temperature
•Gas Flow
 1. 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
• 601 Pro SeriesXL International Safety Analyzer
• Electrical Safety Analyzer performs all primary electrical
safety tests, including mains (line) voltage, protective earth
(ground wire) resistance, MAP (insulation) resistance,
device current, and applied parts (patient leakage) tests.
• It also offers ECG simulation and point–to-point voltage,
leakage, and resistance tests.
• The ESA615 is an all-in-one solution with a multimeter,
electrical safety analyzer and ECG simulator in a single
test instrument.
601 Pro Series XL International
Safety Analyzer
 2. Performance Analyzers
• Electrosurgery
• Defibrillator / Pacemaker
• Infusion Device
• Incubator
• Pressure Meters
• Gas-Flow
• Oxygen Analyzers
• Medical Scopemeters
 Electrosurgery
QA-ES Electrosurgery Analyzer
 Defibrillator / Pacemaker
• Impulse 6000D/7000DP
Defibrillator/External Pacer Analyzer and
Tester
• SigmaPace™ 1000 External Pacemaker
Analyzer
• QED 6 Defibrillator Analyzer
 Impulse 6000D/7000DP
Defibrillator/External Pacer
Analyzer and Tester
SigmaPace™ 1000 External
Pacemaker Analyzer
 Infusion Device
IDA 4 Plus Multi-Channel
Infusion Device Analyzer
• The infusion device tester measures
instantaneous flow, average flow, occlusion
pressure, and analyzes patient-control
analgesia (PCA) units.
• Infusion device tester records infusion
pump test results internally and provides
easy-to-read test-result graphs live right on
the analyzer’s screen.
 Incubator
INCU™ Incubator Analyzer
• Incubator Analyzer specifies temperature,
humidity, sound and airflow characteristics
of incubators.
 Pressure Meters
• DPM2Plus Pressure Meter
• DPM4 Parameter Tester
• DPM1B Pneumatic Transducer Tester
• 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.
• When coupled with the optional Parabolic Flow Adapter
accessory, the pressure displayed on the DPM2Plus can be
quickly interpreted by using the look-up-table supplied
with the parabolic flow adapter. This time-saving feature
helps determine flow from medical devices.
DPM2Plus Pressure Meter
DPM4 Parameter Tester
 Gas-Flow
• VT PLUS HF Gas Flow Analyzer
• ACCU LUNG Portable Precision Test
Lung
• VT MOBILE Gas Flow Analyzer »
VT PLUS HF Gas Flow
Analyzer
• The VT PLUS HF is Fluke Biomedical’s premier general-purpose gas-
flow analyzer. In addition, special display modes and bi-directional
flow make it perfect for fully and efficiently testing both conventional
mechanical ventilators and high-frequency ventilators.. Multiple
special-function tests make troubleshooting quick and efficient.

• VT PLUS HF has the capability to measure either high- or low-flow

and pressure, replacing the need for gauges and flow meters. It
measures 21 ventilator parameters and can display all of them on one
screen. Results can be printed directly from the unit or from a PC with
included Windows-compatible software. VT PLUS HF also has
onboard graphing capability and shows the minimum, maximum,
average, and absolute measurement for all parameters.

• VT PLUS HF can be operated with a variety of precision test lungs to

ensure that ventilators are tested to manufacturers’ specifications and
clinical expectations with a fully NIST-traceable testing system.
Oxygen Analyzers MaxO2 PLUS
AE Oxygen Analyzer
• analyzer that measures the oxygen concentration in a flow
of gas from a medical gas source or through a medical gas-
flow device such as a ventilator or anesthesia system, or
within an infant incubator.
• It is handheld and rugged to suit the needs of portable use.
• The MaxO2 PLUS AE comes equipped with a two-year
warranty on both analyzer and sensor.
199XRay Medical ScopeMeter
• Fluke Biomedical announced today that it has released the 199 X-
RAY Medical ScopeMeter and 35080M Non-Invasive kVp Divider
kit.
• This powerful combination significantly streamlines x-ray system
calibration, QA or corrective maintenance procedure setup, and
analysis.
• "The 199XRAY Medical ScopeMeter high-performance oscilloscope
is ideal for engineers who need the full capabilities of a high-
performance oscilloscope in a handheld, battery-powered instrument,"
said Gary Kaufmann, Product Manager for Fluke Biomedical.
• "The 35080M Non-Invasive kVp Divider can eliminate the need for
bulky and heavy high-voltage divider tanks. It's so compact in size that
it fits into a shirt pocket." The 35080M quickly and accurately
measures kV for all modalities. The unit checks both above and below
table tubes and digitally displays the peak and average kV values along
with the waveform on the 199XRAY Medical ScopeMeter.
Alternatively, the Model 35050AT Dosimeter and optional Excel Add-
in software can be used to display and record kV readings.
• The 199X-RAY Medical ScopeMeter has all of the normal
oscilloscope functions, as well as the speed, performance,
and analysis power for the more demanding applications.
This high-performance oscilloscope offers specifications
found on top-end bench instruments. With up to 200 MHz
bandwidth, 2.5 GS/s real-time sampling, and a deep
memory of 27,500 points per input, the 199X-RAY is ideal
for engineers who need the full capabilities of a high-
performance oscilloscope in a handheld, battery-powered
instrument.
• In addition, the 199X-RAY is especially designed for use
with x-ray systems. This ScopeMeter displays kVp
waveforms and direct kVp values simultaneously on an
easy-to-read screen. Now you no longer have to waste time
calculating scope traces to derive the kVp values.
• Field Applications
– Dual input – 200, 100 or 60 MHz bandwidth
– Up to 2.5 GS/s real-time sampling per input
– Connect-and-View™ automatic triggering and a full range of manual
trigger modes
– Digital Persistence for analyzing complex dynamic waveforms, similar to
an analog scope
– Fast-display update rate for seeing dynamic behavior instantaneously
– Automatic capture and replay of 100 screens
– 27,500 points-per-input record length using ScopeRecord mode
– TrendPlot paperless chart recorder for trend analysis up to 22 days
– Up to 1,000 V independently floating isolated inputs
– Waveform reference for visual comparisons and automatic pass/fail
testing of waveforms
– Vpwm function for motor drive and frequency inverter applications
– 1000 V CAT II and 600 V CAT III safety certified
– Four-hours-rechargeable NiMH battery pack
 3. Simulators & Controllers
• Multiparameter 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
• DataSim 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
 Sp02 Simulators
Index 2 Pulse Oximeter
Simulator
DALE40 Phototherapy
Radiometer
Software Ansure
 Course Description
• This course introduce the therapeutic &
prosthetic devices like: Defibrillators,
Pacemakers, Electrical Surgical Unit,
Ventilators, incubators, Artificial kidneys -
Endoscopy - Laser devices - Anesthesia
equipment, Pulse Oximeter, Patient
Monitor, Phototherapy, Infusion Pump
 Course Goals
• Understand each instrument theory, background
and principle of operation.
• Describe the concept of the Electrical Safety
Analyzers for each equipments, The international
safety standards like AAMI, ANSI, IEC.
• Describe the organization of the Computerized
Maintenance Management System in planed
preventive maintenance.
• Simulate human biomedical signal to test the
reliability of the biomedical equipment.
 Course Textbooks

• (1) The Biomedical Engineering Handbook, 3rd Edition (3

Volume Set)by: Joseph D. Bronzino
(2) Encyclopedia of Medical Devices and Instrumentation,
6 Volume Set - Second Edition by: John G.
Webster Part1 Part2 Part3 Part4
(3) Medical Instrumentation Application and Design, 4th
Edition by: John G. Webster
(4) Handbook of Modern Sensors: Physics, Designs, and
Applications, Fourth Edition by: Jacob Fraden
(5)Biomedical Instrumentation: Technology and
ApplicationsBy R. Khandpur
 Useful Links
• Useful Links

• http://www.k-space.org/AAMI/ user name:

aami password: bme
Fluke Biomedical Test Equipment
http://assets.fluke.com/Biomedical/Video/ESA612.html
http://assets.fluke.com/BiomedDocs/PPP089_PS400_Self-
Paced_Training_2010/player.html
MRE Dynatech NV LLC
FDA: List of Medical Device Recalls
FDA: How to Report A Medical Device Problem

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