Southeastern Biomedical
Associates, Inc.
• Boyd Campbell CBET, CRES – Southeastern
Biomedical Associates, Inc
• Ashley Greco Sales – Sales Consultant –
Southeastern Biomedical Associates, Inc
• Chris Ritchie – Regional Sales Manager – Fluke
Biomedical
Trusted Partners
• “Our customer has
the right to get a little
more than they paid
for.”
• -- John Fluke
Biomedical / Clinical
Engineering
Representative Company Presentation
Defibrillation
Usage and Testing
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History
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1899 – University of Geneva
1933 – Use of a hollow needle to pass current
1947 – First use on a human
1950s – External Defibs appear
1959 – First DC defib
1980’s – Biphasic Technology appears
Defibrillation
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MyGyver Defibrillator
• What does a defib do?
• What does a defib not do?
– Start the heart
– Work on asystolic patient
Basic Function of a Defib
• Electronic device used to depolarize
myocardium from atrial or ventricle fibrillation.
• Fibrillation is cause by ectopic beats.
• Two modes of operation: Defibrillate and
Synchronized (sync) Cardioversion.
• Internal and external usage.
• Designed to provide up to 360 Joules for
external and 50 joules for internal.
CardioVersion - Sync
• Delivery of energy to the heart during the phase
of ventricular depolarization.
• Normally used during atrial fibrillation.
• Energy must be delivered after detection of R
wave of QRS complex.
• Depolarization - is the reversal of resting
potential in excitable cell membranes when
stimulated.
Monophasic vs Biphasic
• Monophasic – Single polarity waveform, Uses
higher energy.
• Biphasic – Dual polarity waveform, Uses lower
energy.
Definitions
• Energy- Joule – (Voltage x current x time)
• Current – (voltage / impedance) What actually
defibrillates the heart
• Impedance – Resistance to electrical flow
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Biphasic Waveforms
• Rectilinear – varies impedance (Zoll)
• BTE – varies voltage (Physio, Philips)
Changes in impedance
• Current – (voltage / impedance)
Regulatory issues
• Nearly 300,000 Americans collapse each year when their hearts
stop pumping blood
– External defibrillators are designed to save their lives
• Defibrillators are malfunctioning far too often, costing people their
lives
– 28,000 reports of defibrillators failing
– Manufacturers issued 68 recalls
• The FDA has become increasingly concerned about rapidly rising
reports of problems with the devices
– The agency concluded that many of the failures could be prevented
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Q: Are 50 Ω test loads enough to ensure output
conditions of modern-day defibrillators?
– Do all of your hospital’s patients have the same input
impedance? No!
A: Testing beyond the 50 Ω load is necessary to
ensure defibrillator inventory performance of
modern defibrillators
Test Loads
Q: What loads are recommended?
A: Section 6.8.3 of the IEC 60601-2-4 standard
and AAMI DF80 standards require defibrillators
to be tested on different resistance loads of 25,
50, 75, 100, 125, 150 and 175 ohms to ensure
proper current is delivered to patients with
different impedances.
Testing continued
• Charge Time - Max. energy charge time should
not exceed 15 sec. on the 10th charge.
• Paddle continuity - resistance from paddle to the
appropriate pin of the paddle connector should
not exceed .15 ohms.
• Overall delay in sync. mode from defibrillator is
60 ms after R wave. Some differences by
manufacturer. Must fire before T wave.
• Internal paddle testing.
AED Testing
• Do they really need testing?
• What do we test?
This action, an FDA Class I recall, affects only
DDU-100 series AEDs shipped with 2.004
software or earlier. It issued the recall based
on two possible conditions, which in rare
cases may cause an affected AED to cancel
shock during the charging process and not
provide therapy, which may result in failure
to resuscitate the patient. Both conditions
are not detectable by the periodic self-test
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Defibrillator testers are regulated by 510(k)
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 870 -- CARDIOVASCULAR DEVICES
Subpart F--Cardiovascular Therapeutic Devices
Sec. 870.5325 Defibrillator tester
(a)Identification. A defibrillator tester is a device that is connected to the output of a
defibrillator and is used to measure the energy delivered by the defibrillator into a
standard resistive load. Some testers also provide waveform information
(b)Classification. Class II (performance standards)
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Questions?
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The End