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July 2005

Product Comparison
Defibrillators, External, Automated; Semiautomated

UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRI’s Universal Medical Device
Nomenclature System™ (UMDNS™):
9 Defibrillators, External, Automated [17-116]
9 Defibrillators, External, Semiautomated [18-500]

Table of Contents

Scope of this Product Comparison ...............................................................................................................................3


Purpose..........................................................................................................................................................................3
Cardiac physiology...................................................................................................................................................3
Principles of operation..................................................................................................................................................5
Defibrillator waveform ............................................................................................................................................5
Defibrillation procedure ..........................................................................................................................................5
Analysis of cardiac rhythm......................................................................................................................................6
Pediatric application................................................................................................................................................6
Accuracy ...................................................................................................................................................................6
Battery care and maintenance ................................................................................................................................7
Over-the-counter AED .............................................................................................................................................7
Reported problems........................................................................................................................................................7
Purchase considerations...............................................................................................................................................8
ECRI recommendations...........................................................................................................................................8
Other considerations................................................................................................................................................9
Stage of development..................................................................................................................................................10
Bibliography................................................................................................................................................................10
Standards and guidelines...........................................................................................................................................11
Citations from other ECRI publications ....................................................................................................................13
Supplier information ..................................................................................................................................................18
About the chart specifications....................................................................................................................................22
Product Comparison Chart ........................................................................................................................................23
Defibrillators, External, Automated; Semiautomated

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services research agency established in 1955. HPCS provides comprehensive information to help
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Defibrillators, External, Automated; Semiautomated

July 2005
Defibrillators, External, Automated; Semiautomated

Scope of this Product Comparison


This Product Comparison covers fully automated and semiautomated external defibrillators
(AEDs), as well as automated public-access defibrillators (PADs). Fully automated external
defibrillators determine whether a defibrillating shock is needed and automatically charge and
discharge to deliver a needed shock to the patient. Semiautomated units analyze the
electrocardiogram (ECG) and charge in preparation for shock delivery, but the operator activates the
discharge. Standard AEDs are used within the hospital by first-responding nurses or carried by
police officers and firefighters who respond to medical emergencies. PAD units are designed for use
by individuals who arrive on the scene before trained emergency medical personnel, such as security
guards and flight attendants; these users usually have no medical training but are trained in AED
use. Some AEDs can be switched to a manual mode. Totally manual defibrillators are covered in the
Product Comparison titled DEFIBRILLATORS, EXTERNAL, MANUAL; DEFIBRILLATOR/PACEMAKERS,
EXTERNAL.
For related information, see the following Product Comparisons:
• Defibrillator/Pacemakers, Implantable
• Pacemakers, Cardiac, External, Invasive Electrodes, Transvenous
• Pacemakers, Cardiac, Implantable
These devices are also called: AEDs, automated external defibrillators, automatic external
defibrillators, semiautomated defibrillators, and shock-advisory defibrillators.

Purpose
AEDs deliver a high-amplitude current impulse to the heart in order to restore normal rhythm
and contractile function in patients who are experiencing ventricular fibrillation (VF) or ventricular
tachycardia (VT) that is not accompanied by a
palpable pulse. AEDs differ from conventional
defibrillators in that AEDs can analyze the ECG
rhythm to determine whether defibrillation is
necessary; this eliminates the need for the user to
interpret the cardiac rhythm before delivering a
shock. AEDs are designed to be used primarily by
first responders to cardiac emergencies, who may
not be fully trained in advanced cardiac life support
(ACLS). In the prehospital setting, these emergency
personnel can include emergency medical
technicians (EMTs), firefighters, law enforcement
officers, and paramedics. More recently, flight
attendants, security guards, and others (sometimes
called traditional targeted responders; see Table) may be expected to use PAD units. AEDs can also
be used in areas of the hospital where advanced life support personnel are not readily available.

Cardiac physiology

The heart is stimulated to contract by a group of specialized myocardial cells called the sinoatrial
(SA) node, located at the junction of the superior vena cava and the right atrium. The SA node is the
heart’s natural pacemaker; it generates a spontaneous electrical stimulus that is conducted through
the atria and causes them to contract. The electrical stimulus is transmitted to the atrioventricular
(AV) node, located at the septal wall of the right atrium, and eventually to the ventricles,

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Defibrillators, External, Automated; Semiautomated

Who Uses AEDs?

Prehospital
Prehospital users can be classified as follows:
• First responders — Trained individuals who have a duty to respond to medical
emergencies. Examples include emergency medical services (EMS) personnel,
police officers, and firefighters.
• Targeted responders — Individuals within the general public who are likely or
willing to act in the case of a medical emergency, trained in AED use, and given
access to an AED. Targeted responders can be further classified as traditional or
nontraditional targeted reponders.
• Traditional targeted responders are individuals who, although they are not
first responders, are likely to perceive a duty to respond to a medical
emergency. Examples include security guards, stadium and golf course
personnel, and flight attendants.
• Nontraditional targeted responders are individuals within the general
public who express a willingness to respond to medical emergencies and
who volunteer for training. Examples include residents of large apartment
buildings, workers in high-rise office buildings, and even family members of
individuals known to be at risk for sudden cardiac arrest.
• Other members of the lay public — Some observers speculate that AEDs may, in
the future, be used by members of the public who have not specifically been
trained in AED use and who have not formally been given access to an AED. A
passerby who might otherwise perform cardiopulmonary resuscitation would be
one example of this type of user. (Note that AEDs are not currently marketed for
this purpose.)
In-hospital
AEDs are used in the hospital to help reduce cardiac arrest response times in certain
areas of the facility and even to replace the more expensive manual defibrillator/monitors for
some applications. Within the hospital, the device may be used in one of two different
implementation schemes, depending on the location of use and the staff’s level of training.
In-hospital users can be classified as follows:
• Advanced as well as basic users — The same device is used as an automated
unit by first-responding nurses or other personnel trained in basic life support
(BLS) and, if necessary, as a manual unit by physicians, members of the
resuscitation team, or other staff trained in advanced life support, when they
arrive.
• Basic users only — The device is used strictly as an automated unit by first-
responding nurses or other personnel trained in BLS. From an AED training
and use standpoint, this scheme is similar to prehospital use of an AED by first
responders.

stimulating them to contract.


The heart is able to pump effectively only when the contractions of all its muscle fibers are
precisely synchronized. In VF, the normal rhythmic ventricular contractions are replaced by rapid,
irregular twitching that results in ineffective and severely reduced pumping. If normal rhythm is not
restored quickly, death is imminent. Defibrillation is accomplished by applying an electric shock to
the heart to depolarize the myocardium and stop the uncoordinated contractions. The SA node can

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Defibrillators, External, Automated; Semiautomated

then resume normal function, and sinus rhythm can be restored. The earlier defibrillation occurs
after the onset of VF, the better the chance for survival; for every minute that passes after the onset
of VF, the chance for survival decreases by 10%. Performing cardiopulmonary resuscitation (CPR)
while waiting for a defibrillator can extend VF and delay the onset of asystole; however, CPR cannot
convert VF to a normal sinus rhythm. Because AEDs are simpler to operate and can be used by
personnel with considerably less training than those qualified to perform ACLS, they permit first
responders to defibrillate, which can reduce the patient’s time in fibrillation and improve the
patient’s prognosis.

Principles of operation
AEDs can be classified as either fully automatic or semiautomatic. Fully automatic models
require only that the user apply defibrillator electrodes to the patient and activate the unit, which
then analyzes the ECG rhythm obtained through the disposable defibrillation electrodes and
determines whether a defibrillation countershock is needed; if it is, the device automatically charges
and discharges.
Most AEDs are semiautomatic. These units analyze the patient’s ECG and notify the operator
when defibrillation is indicated and charge automatically. The operator then discharges the
defibrillator. AEDs can use visual messages and/or voice-synthesized instructions to notify the
operator of the proper course of action.
AEDs typically include a code documentation device, such as a
cassette recorder, memory module, or personal computer data
card; disposable adhesive defibrillation electrodes through which
the cardiac rhythm can be monitored and the electric shock
delivered; an LCD (liquid crystal display) or other display to give
the user status messages (patient and/or defibrillator), to display
the ECG waveform, or to prompt the user to initiate a shock; and
audible voice prompts.

Defibrillator waveform

The defibrillator waveform is a graph of the current delivered


versus time. Until recently, all external defibrillators used one of
two waveforms: the monophasic damped sinusoid or the
monophasic truncated exponential. AEDs with these waveforms
typically deliver 200-, 200- or 300-, or 360-joule (J) shocks in an
attempt to convert VF to an organized rhythm and use relatively large capacitors and batteries,
which limit how small and lightweight these devices can be made.
Recently, the technology previously designed for implantable cardioverter-defibrillators (ICDs)
has been made available in AED units. Virtually all ICDs sold today use biphasic waveforms. These
waveforms deliver current that flows first in a positive direction and then in a negative direction —
in effect creating two phases of waveform delivery — and hold the promise of requiring less energy to
be delivered for effective defibrillation. There are two types of external biphasic defibrillators on the
market, typically referred to as high energy and low energy. High-energy external biphasic
defibrillators are generally designed for use at greater than 200 J, while low-energy external
biphasic defibrillators are designed for use at less than 200 J. Defibrillators using this newer
technology may be smaller, lighter, less demanding of batteries, lower maintenance, and possibly
more affordable. Studies also suggest that patients receiving lower-energy biphasic shocks have a
more normal postshock rhythm than those receiving higher-energy monophasic shocks. This may be
due to a decrease in the amount of myocardial cell damage incurred during the shock.

Defibrillation procedure

Operators are trained to use an AED only on patients in cardiac arrest who are unconscious,

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pulseless, and not breathing spontaneously. To avoid misinterpretation from analysis of a rhythm
that is not associated with cardiac arrest, an accurate assessment of the presence of cardiac arrest is
very important before connecting the patient to an AED. Once cardiac arrest is confirmed, the AED
is turned on, and, if available, a voice recorder is automatically activated to document the user’s
comments and other sounds at the emergency scene. The patient’s ECG can also be recorded. The
operator attaches two adhesive defibrillator electrodes to the cables or directly to the AED and
applies the electrodes to the patient. One electrode is usually placed on the patient’s chest near the
upper-right sternal border, and the other is placed on the lower-left ribs over the apex of the heart.
The adhesive electrodes must be carefully applied to ensure good contact with the skin because
unlike paddles, these electrodes do not allow the user to apply pressure and thereby lower
transthoracic impedance by reducing the resistance between the patient’s skin and the electrodes.
All biphasic AEDs measure chest impedance during the first 1/1,000 of a second of the shock. The
shock can then be altered to deliver the appropriate output for the particular patient.
After the electrodes have been attached to the patient, CPR is discontinued, and either the user
activates the analysis function or the AED will automatically analyze the rhythm to determine
whether defibrillation is necessary. After analysis is initiated, all physical contact with the patient
must cease for the remainder of the defibrillation process. Depending on the AED, analysis takes
from 5 to 15 seconds; in fully automatic models, a shock is then automatically delivered when the
rhythm analysis determines it is necessary. Before the shock, the AED indicates that the capacitors
are charging and warns that a shock is imminent. In semiautomatic units, LCDs, visual alarms, or
voice-synthesized instructions prompt the user to press a button to deliver the shock. Before a shock
is delivered, the user of any defibrillator must alert the immediate personnel to the impending shock
by loudly stating “clear” or a similar warning.
After the first shock, analysis is activated again either manually or automatically, and the
defibrillator reanalyzes the cardiac rhythms to determine whether the heart has resumed its normal
beat. If fibrillation is still occurring, the device alerts the user and advises another shock. This
procedure repeats until three shocks have been delivered to the patient. CPR should be resumed for
one minute if normal rhythm has not been restored after the third shock; if the patient is confirmed
to be pulseless and not breathing after CPR, the defibrillation procedure should be resumed.

Analysis of cardiac rhythm

AEDs use algorithms to analyze a patient’s cardiac rhythm. A number of ECG signal
characteristics are analyzed, including amplitude, frequency, and waveform shape. Analysis
typically begins by dividing the ECG into discrete segments, each a few seconds long. Most AEDs
require that at least two of three consecutive segments analyzed elicit a decision to shock before a
shock can be delivered. Most AEDs attempt to filter out sources of interference capable of generating
artifacts on a patient’s ECG that might lead to misinterpretation. Most AEDs can also check for poor
electrode contact or loose or damaged electrodes; some units are designed to detect a patient’s
movements and/or the moving of a patient by others.

Pediatric application

Some AED suppliers have received U.S. Food and Drug Administration (FDA) approval to use
their devices on children younger than eight years of age. When pediatric pads are attached to an
AED, the delivered energy should be limited to levels safe for pediatric patients. Alternatively, if the
unit is not intended for use with pediatric patients, either (1) pediatric pads should not be able to be
connected, or (2) if they can be connected, the unit should not deliver a shock. For more information
on pediatric defibrillation, see the Health Devices citation below.

Accuracy

The accuracy of an AED’s rhythm-recognition algorithm is usually described in terms of


sensitivity and specificity. Sensitivity represents the AED’s ability to identify rhythms that should

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be shocked (e.g., VF). It is defined as the percent of correct decisions to shock out of the total number
of truly shockable rhythms. Specificity represents the ability of an AED to identify rhythms that
should not be shocked. It is defined as the percent of truly nonshockable rhythms that the device
made the correct decision not to shock. Ideally, AEDs would have 100% sensitivity as well as 100%
specificity. However, this is not realistic because there are trade-offs between the two. In general,
AEDs favor specificity: they avoid shocking nonshockable rhythms. In addition, the recommended
practice of attaching AEDs only to pulseless, unconscious patients helps to ensure that they will not
be used to analyze a large number of nonshockable rhythms.
The American National Standards Institute/Association for the Advancement of Medical
Instrumentation (ANSI/AAMI) standard for AEDs and remote-control defibrillators provides
minimum performance standards by which to measure the results of AED testing (see Standards
and Guidelines below). According to this standard, the sensitivity for recognizing VF at an amplitude
of 200 µV or greater should exceed 90% in the absence of artifact. For devices that detect VT, the
sensitivity should exceed 75%. The specificity of the device in correctly differentiating nonshockable
rhythms should exceed 95% in the absence of artifact.

Battery care and maintenance

AEDs use sealed lead-acid (SLA), nickel-cadmium, or lithium batteries. When possible, SLA
batteries not being used should be charged continuously at room temperature until they are fully
charged, which can take from 4 to 24 hours. Units that offer disposable lithium batteries do not
require recharging, thus simplifying AED use. Most AED manufacturers recommend that batteries
be charged after each use and replaced every one to two years. Although battery life depends heavily
on usage and maintenance practices, routine replacement better ensures that the battery will
provide the desired performance when needed. Rechargeable batteries should not be used in PAD
applications. For a more detailed discussion, see the Health Devices article on battery maintenance
listed below.
One unit covered in this Product Comparison is designed for in-hospital monitoring and automatic
defibrillation of patients who are deemed to be at high risk of sudden cardiac arrest. The unit
continuously monitors the patient’s cardiac rhythms through disposable electrodes and responds by
automatically delivering either cardioversion pacing or shock within seconds of detecting VT or VF,
depending on the rhythm detected. After setting up the device and attaching the electrodes to the
patient, no clinical personnel are needed to deliver the therapy.

Over-the-counter AED

For the first time, the U.S. FDA has cleared an AED for over-the-counter sale. The device is
designed for lay users to use on patients at least 8 years old and weighing at least 55 pounds;
smaller pads for use on infants are available by prescription. FDA notes that the device is covered as
a tracked device used outside user facilities under the Safe Medical Devices Act. Healthcare facilities
supplying AEDs for use outside the facility (e.g., physician offices, off-site imaging centers, patient
homes) should have tracking provisions in place to notify the manufacturer at receipt, upon request,
and on permanent disposal of the devices as they would for other tracked devices. FDA’s
announcement is available at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01314.html.

Reported problems
One problem associated with defibrillation is skin burns at the electrode sites. First- and second-
degree burns are especially likely to occur during repeated defibrillation attempts, which require
successively higher energies. Burns are usually caused by a high current flow through a small area
(e.g., an upturned edge of a defibrillation electrode) and/or an increased resistance (e.g., dried gel or
adhesive). In addition to increasing the risk of burns, poor application technique may also reduce the
energy delivered to the patient’s heart.
The operator should avoid physical contact with the patient during defibrillation. Therefore, CPR

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and/or mouth-to-mouth resuscitation must be interrupted while the AED performs rhythm analysis,
charges its capacitor, and delivers the electric shock. According to the American Heart Association
(AHA), the incidence of inappropriate shocks with AEDs has been minimal; however, it is
recommended that AEDs be placed in the analysis mode only after all movement — particularly
patient transport — and CPR have stopped.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Medical
Device Alert warning healthcare workers of the potential for a higher-than-necessary energy level to
be used with biphasic defibrillators. MHRA states that the rapid advances in biphasic technology
and the differences in energy-level protocols between biphasic and more traditional monophasic
devices have caused confusion in healthcare facilities. In the statement, the organization warns that
the 200 J/200 J/360 J sequence of shocks recommended for monophasic devices is not appropriate for
biphasic devices and that confusion has occurred when both monophasic and biphasic devices are
available in the same clinical area. MHRA recommends that all healthcare providers who might use
a defibrillator be educated and trained regarding appropriate use of the equipment. In particular,
providers should be informed that energy levels may vary among different defibrillators.
The LCD of some AEDs can be harder to see than other display technologies (e.g., CRTs [cathode
ray tubes]), especially if not viewed while standing directly in front of the screen or if viewed in
brightly lit areas, which can cause reflections or dark areas.

Purchase considerations
ECRI recommendations

Included in the accompanying comparison chart are ECRI’s recommendations for minimum
performance requirements for automated and semiautomated defibrillators. The requirements have
been separated into those for standard AEDs (automated and/or semiautomated) and those for PADs
(automated). The two listings are differentiated by the intended user group and application but are
interchangeable in many cases. Both types of unit are designed for users with minimal training.
Standard AEDs will often be placed in areas within the hospital where starting defibrillation
would otherwise take longer than three minutes and will be used by first-responding nurses or
carried by police officers and firefighters who respond to medical emergencies. PAD units are
designed for use by individuals who may arrive on the scene before first responders, such as security
guards and flight attendants. These users often have no medical training but are trained in AED
use. The two types of AEDs will differ mostly by the level of voice prompting, with PADs offering
more detailed instructions.
The ECG must be obtained through disposable defibrillation electrodes. The analysis program
must analyze ECG data and make a decision in less than 14 seconds. The AED must deliver
defibrillation energy at preset levels and sequences. The energy sequences must be programmable
without assistance from service personnel. The AED should charge to maximum energy in less than
15 seconds.
The AED should start analysis automatically or prompt the operator to press an analyze button
when the unit is turned on to prevent delays in initiating analysis. When the AED is not in analyze
mode, the device should provide an audible and visual indication of the presence of, or a change to, a
potentially shockable rhythm. An AED should be able to deliver a set of 3 shocks within 90 seconds;
the AED should not automatically deliver more than 3 successive detection-shock episodes.
ECRI recommends that charge/discharge sequences follow AHA protocols. Semiautomated
defibrillators, which are equipped with a discharge control, should (1) automatically disarm when
fully charged if not intentionally discharged within 10 to 30 seconds after charging, (2) provide a
quick and obvious method of disarming the unit manually if the charge is held for more than 30
seconds, and (3) lose no more than 15% of the initial deliverable energy before automatic disarm in
either AED or manual mode. Fully automated defibrillators should not hold their charge for longer
than 10 seconds before disarming.

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Most AEDs on the market employ a biphasic waveform. Because of strong clinical evidence
supporting the superiority of the biphasic waveform technology, ECRI recommends purchasing
biphasic rather than monophasic units.
Manual override can allow a more advanced user to continue a resuscitation attempt upon arrival
without requiring removal of the current defibrillator. This feature would be more commonly found
on standard AEDs.

Other considerations

Due to their simple design and ease of use, AEDs require less user training in rhythm recognition
and device operation, as well as less continuing education time, compared with conventional
defibrillators. However, in applications for which the incidence of cardiac arrest is low, skills
maintenance is important for both conventional defibrillator and AED users.
Some AEDs are equipped with an ECG display. AEDs with ECG displays are useful in
applications in which a person is present who is trained in ACLS and can recognize rhythms by
viewing an ECG. An ECG display will also permit the rescue to continue without the need to detach
the paddles or electrodes to switch the plug-in cord from the AED to a compatible
defibrillator/monitor. On the other hand, an ECG monitor will add to the complexity, size, and cost of
the device. Also, users of AEDs are typically not trained to read ECGs and might be distracted by the
display.
AEDs have various documentation features. Some have dual-channel ECG/voice recorders. Others
have solid-state memory, with a device that stores information summarizing the resuscitation
attempt. Still others have removable data cards or memory modules that can store information for
later review and allow it to be downloaded to a database for storage, trending, and report generation.
AED manufacturers offer various forms of software to facilitate information storage and trending,
but many larger emergency medical services systems have developed their own databases.
Most AEDs use disposable defibrillation electrodes, which typically cost between $13.50 and $36
per pair. Disposable electrodes can be a significant expense, depending on how often the AED is
used. Nonrechargeable batteries typically have a higher list price than rechargeable ones, although
they do not require the purchase of a battery charger. Nonrechargeable batteries can deliver
approximately 200 to 300 discharges and have a shelf life of approximately five years. (Shelf-life
estimates are based on batteries that are not in use. Battery life will decrease when the battery is
installed and if the unit performs periodic self-tests). A nonrechargeable battery can be exhausted
after a few days of training.
Rechargeable batteries allow more discharges over their lifetime. However, the number of
discharges depends on how often the AED is used. A fully charged battery delivers approximately 50
discharges; the battery should be replaced every two years. Cost comparisons cannot be provided
unless the use frequency can be specified. However, as a general rule, nonrechargeable batteries will
be less expensive if the AED is used infrequently, and rechargeable batteries will be less expensive if
device use is average to high. Disposal of nonrechargeable batteries is legal in the United States but
not in some parts of Europe. Users should check their regional regulations. Rechargeable batteries
are usually recycled.
AEDs designed for use by first responders in the prehospital environment should be lightweight
and portable to allow for easy transport. To reduce complexity, many of the advanced features of
manual defibrillator/monitors have been stripped from AEDs. The result is an easy-to-use device
that still has all the capabilities needed for the initial response to cardiac arrest. However, a device
capable of more advanced applications (i.e., a full-featured manual unit) may be required after an
AED is used for the initial rescue.
Savings on AEDs can be realized with a trade-in discount, upgrade, or multiple-purchase
agreement with the supplier. If a facility currently uses older models and newer models are now
necessary, the supplier may provide a considerable trade-in discount (e.g., 20% of the purchase
price). (Suppliers may choose to only allow users to trade in/upgrade devices specific to their product
lines.) If the user is implementing all new models, with no trade-ins or upgrades, a multiple-

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purchase discount may be available. This would also apply to all accessories required to operate the
unit or to replace used parts of the defibrillator (e.g., electrode pads).

Stage of development
Defibrillators have been in use for decades, and defibrillation is a well-established and accepted
technique that has undergone extensive clinical testing. AEDs were developed in the late 1970s and
have progressively become smaller, lighter, and more reliable. Originally, AEDs were intended for
use by relatives of people at high risk of VF. However, the initial clinical studies showed less-than-
desirable results in this setting because family members were unable to initiate treatment. Simpler
device operation and better training may again make this a growing area of use. Individuals
qualified to use AEDs include EMTs, firefighters, physicians, nurses, paramedics, other emergency
personnel, and, more recently, security guards and flight attendants. AHA suggests that because
AEDs require less training time and skills maintenance and offer superior device consistency, safety,
and speed of shock delivery, they may completely replace conventional defibrillators at the
prehospital level. Today, these defibrillators have more specific instructions added to voice prompts,
as well as voice prompts for guidance on CPR.
Because two of every three cases of sudden cardiac arrest occur outside the hospital, AEDs have
gained the most widespread acceptance in the prehospital environment, where they are increasingly
being used by EMTs and other first responders. AHA has strongly endorsed the principle of early
defibrillation, which states that “all those whose jobs require that they perform CPR be trained to
operate and permitted to use defibrillators, particularly AEDs.”
AHA’s principle of early defibrillation also encourages the use of AEDs in the hospital. AEDs are
likely to be increasingly important in locations where response times average more than two minutes
(e.g., outpatient and diagnostic areas). However, in many hospitals, defibrillation is still performed
by personnel trained in ACLS, who are often specifically designated to respond to cardiac arrest (e.g.,
code teams), and conventional defibrillator/monitors are still in widespread use.
AHA has suggested extending the principle of early defibrillation to the public, who are often the
first on the scene in cases of cardiac arrest. AEDs are beginning to be placed in locations such as
office buildings, stadiums, fitness clubs, and casinos, where they can be used within minutes of
cardiac arrest. In early 1996, the Cardiac Arrest Survival Act (H.R. 3022) was introduced in
Congress. This legislation calls for a federal program establishing training programs in lifesaving
first aid and the use of AEDs.

Bibliography
Achleitner U, Rheinberger K, Furtner B, et al. Waveform analysis of biphasic external defibrillators.
Resuscitation 2001 Jul;50(1):61-70.
Albrecht GB. Defibrillators: past, present, and problems. Int J Trauma Nurs 2001 Jan-Mar;7(1):23-5.
American Heart Association. Automated external defibrillators and ACLS: a new initiative from the
American Heart Association. Am J Emerg Med 1991 Jan;9(1):91-4.
American Heart Association. International guidelines 2000 for CPR and ECC. Part 4: the automated
external defibrillator: key link in the chain of survival. Circulation 2000 Aug 22;102(8):I-60-76.
American Heart Association. International guidelines 2000 for CPR and ECC. Part 6: advanced
cardiovascular life-support — Section 2: defibrillation. Circulation 2000 Aug 22;102(8):I-90-4.
Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverter-defibrillator in
acutely terminating episodes of ventricular fibrillation. Am J Cardiol 1998 May 15;81(10):1253-6.
Bardy GH, Marchlinski FE, Sharma AD, et al. Multicenter comparison of truncated biphasic shocks
and standard damped sine wave monophasic shocks for transthoracic ventricular defibrillation.
Circulation 1996 Nov 15;94(10):2507-14.

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Defibrillators, External, Automated; Semiautomated

Cleland MJ, Maloney JP, Rowe BH. Problems associated with the z-fold region of defibrillation
electrodes. J Emerg Med 1998 Mar-Apr;16(2):157-61.
Cummins RO. From concept to standard-of-care? Review of the clinical experience with automated
external defibrillators. Ann Emerg Med 1989 Dec 12;18(12):1269-75.
Cummins RO, Eisenberg MS, Litwin PE, et al. Automatic external defibrillators used by emergency
medical technicians: a controlled clinical trial. JAMA 1987 Mar 27;257(12):1605-10.
Geddes LA, Havel W. Evolution of the optimum bidirectional (+/- biphasic) wave for defibrillation.
Biomed Instrum Technol 2000 Jan-Feb;34(1):39-54.
Gilman BL, Brewer JE, Klein TK, et al; (2) Montauk L. Alarming defibrillator headlines [letter and
reply]. Ann Emerg Med 1997 Dec;30(6):836-7.
Gliner BE, Jorgenson DB, Poole JE, et al. Treatment of out-of-hospital cardiac arrest with a low-
energy impedance-compensating biphasic waveform automatic external defibrillator. Biomed
Instrum Technol 1998 Nov-Dec;32(6):631-44.
Great Britain. Medicines and Healthcare Products Regulatory Agency. All biphasic defibrillators (all
manufacturers). London: Department of Health; 2003 Apr 17. 3 p. (Medical device alert; no.
MDA/2003/012).
Handley AJ, Handley SA. Improving CPR performance using an audible feedback system suitable for
incorporation into an automated external defibrillator. Resuscitation 2003 Apr;57(1):57-62.
Jorgenson DB, Skarr T, Russell JK, et al. AED use in businesses, public facilities and homes by
minimally trained first responders. Resuscitation 2003 Nov;59(2):225-33.
Kerber RE. New and exciting developments in defibrillation — what will we be doing in 2010?
Singapore Med J 2001 Sep;Suppl 1:031-2.
Liddle R, Davies CS, Colquhoun M, et al. ABC of resuscitation. The automated external defibrillator.
BMJ 2003 Nov 22;327(7425):1216-8.
Ruskin JN. Automatic external defibrillators and sudden cardiac death [editorial]. N Engl J Med
1988 Sep 15;319(11):713-5.
Schneider T, Martens PR, Paschen H, et al. Multicenter, randomized, controlled trial of 150-J
biphasic shocks compared with 200- to 360-J monophasic shocks in the resuscitation of out-of-
hospital cardiac arrest victims. Circulation 2000 Oct 10;102(15):1780-7.
Stults KR, Brown DD, Kerber RE. Efficacy of an automated external defibrillator in the
management of out-of-hospital cardiac arrest: validation of the diagnostic algorithm and initial
clinical experience in a rural environment. Circulation 1986 Apr;73(4):701-9.
van Alem AP, Vrenken RH, de Vos R, et al. Use of automated external defibrillator by first
responders in out of hospital cardiac arrest: prospective controlled trial. BMJ 2003 Dec
6;327(7427):1312-6.

Standards and guidelines


Note: Although every effort is made to ensure that the following list is comprehensive, please note
that other applicable standards may exist.
American Association for Respiratory Care. Defibrillation during resuscitation [guideline]. Respir
Care 1995 Jul;40(7):744-8.
American College of Cardiology. Early defibrillation [position statement]. 1991 Oct.
American College of Emergency Physicians. Early defibrillation programs [policy statement]. EMS
Committee. 04202. Ann Emerg Med 2001 May;37:557.

©ECRI. All Rights Reserved.


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Defibrillators, External, Automated; Semiautomated

Public training in cardiopulmonary resuscitation and public access defibrillation [policy


statement]. 400274. 1999 Sep. Ann Emerg Med 2000 Jun;35:640-1.
American Heart Association. Automatic external defibrillators for public access defibrillation:
recommendations for specifying and reporting arrhythmia analysis algorithm performance,
incorporating new waveforms, and enhancing safety [statement]. Task Force on Automatic
External Defibrillation. Circulation 1997 Mar;95(6):1677-82.
Improving survival from sudden cardiac arrest: the ‘chain of survival’ concept [statement].
Advanced Cardiac Life Support Subcommittee and the Emergency Cardiac Care Committee.
Circulation 1991 May;83(5):1832-47.
Public access defibrillation [statement]. Task Force on Automatic External Defibrillation.
Circulation 1995 Nov;92(9):2763.
American Heart Association/European Resuscitation Council/Heart and Stroke Foundation of
Canada. Guidelines 2000 for cardiopulmonary resuscitation and emergency cardiovascular care.
International Consensus on Science. Circulation 2000 Aug 22;102(8 Suppl 1):I1-I11.
American National Standards Institute/Association for the Advancement of Medical
Instrumentation. Automatic external defibrillators and remote-control defibrillators [standard].
ANSI/AAMI DF39-1993. 1993.
ASTM International. Practice for performance of prehospital automated defibrillation [standard].
ASTM Committee F30 on Emergency Medical Services. F1255-90 (1995). 1995.
Australasian College for Emergency Medicine. Early access defibrillation in out of hospital cardiac
arrest [policy]. 1997 Mar.
Australian Resuscitation Council. Early defibrillation [policy statement]. 1997 Jul.
Public access defibrillation (PAD) [guideline]. 10.1.3. 2004 Nov.
Canadian Association of Emergency Physicians. Public access defibrillation programs [position
statement]. Public Access Defibrillation Working Group. 2001.
European Resuscitation Council. European Resuscitation Council guidelines for the use of
automated external defibrillators by EMS providers and first responders [guideline]. Early
Defibrillation Task Force. Resuscitation 1998 May;37(2):91-4.
Guidelines 2000 for adult advanced life support. Advanced Life Support Working Group.
Resuscitation 2001 Mar;48(3):211-21.
Guidelines 2000 for adult basic life support. Basic Life Support and Automated External
Defibrillation Working Group. Resuscitation 2001 Mar;48(3):199-205.
Guidelines 2000 for advanced paediatric life support. Paediatric Life Support Working Group.
Resuscitation 2001 Mar;48(3):231-4.
Guidelines 2000 for automated external defibrillation. Basic Life Support and Automated
External Defibrillation Working Group. Resuscitation 2001 Mar;48(3):207-9.
Guidelines 2000 for basic paediatric life support. Paediatric Life Support Working Group.
Resuscitation 2001 Mar;48(3):223-9.
International Electrotechnical Commission. Cardiac defibrillators — cardiac defibrillators —
monitors — part 1: operation [technology information report]. IEC/TR3 61288-1 (1993-10). 1993.
Cardiac defibrillators — cardiac defibrillators — monitors — part 2: maintenance [technology
information report]. IEC/TR3 61288-2 (1993-10). 1993.
Medical electrical equipment — part 1: general requirements for safety [standard]. IEC 60601-1
(1988-12). 1988.
Medical electrical equipment — part 1: general requirements for safety. Amendment 1 [standard].
IEC 60601-1-am1 (1991-11). 1991.
Medical electrical equipment — part 1: general requirements for safety. Amendment 2 [standard].

©ECRI. All Rights Reserved.


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Defibrillators, External, Automated; Semiautomated

IEC 60601-1-am2 (1995-03). 1995.


Medical electrical equipment — part 1-1: general requirements for safety. Collateral standard:
safety requirements for medical electrical systems. 2nd ed. IEC 60601-1-1 (2000-12). 1992
(revised 2000).
Medical electrical equipment — part 1-2: general requirements for safety. Collateral standard:
electromagnetic compatibility — requirements and tests. IEC 60601-1-2 (2001-09). 1993 (revised
2001).
Medical electrical equipment — part 2: particular requirements for the safety of cardiac
defibrillators and cardiac defibrillator/monitors [standard]. IEC 60601-2-4 (1983-01). 1983.
National Association of EMS Physicians. Early defibrillation [position paper]. Prehosp Emerg Care
2000 Oct-Dec;4(4):358.

Citations from other ECRI publications


Health Devices
Automated external defibrillators. 1993 May-Jun;22(5-6):289.
Battery care and maintenance. 1993 May-Jun;22(5-6):284.
Defibrillator/monitors and external noninvasive pacemakers [evaluation]. 1993 May-Jun;22(5-6):212-
94.
The importance of early defibrillation. 1993 May-Jun;22(5-6):211.
Defibrillator/monitors and external noninvasive pacemakers [evaluation update]. 1993
Dec;22(12):579-82.
Automated external defibrillators [evaluation]. 1995 Aug-Sep;24(8-9):303-58.
Automated external defibrillators [update evaluation]. 1996 Aug;25(8):271-98.
Automated external defibrillators (AEDs) in the hospital [Talk to the specialist]. 1997 Feb;26(2):79.
Focus on automated external defibrillators [perspective, update evaluation, and technology
management guide]. 1999 May-Jun;28(5-6).
A new defibrillator/monitor application. In-hospital use by basic as well as advanced users. 2000
Sep;29(9):329.
Defibrillator/monitor/pacemakers [update evaluation and supplementary articles]. 2000
Sep;29(9):301-32.
External biphasic defibrillators: should you catch the wave? [guidance article]. 2001 Jun;30(6):219-
25.
Defibrillator/monitor/pacemakers [update evaluation]. 2002 Feb;31(2):45-64.
Not for children: most automated external defibrillators will deliver too much energy to pediatric
patients [hazard report]. 2002 Feb;31(2):72-4.
Maintaining public access AEDs [Talk to the specialist]. 2002 Nov;31(11):420.
AEDs in your facility. A risk management perspective. 2003 Jun;32(6):235-40.
Automated external defibrillators (AEDs) [evaluation]. 2003 Jun;32(6):223-34.
Automated external defibrillators (AEDs) [evaluation]. 2004 Jun;33(6):189-221.
Automated external defibrillators (AEDs) [evaluation]. AED Now Available Over-the-Counter. 2004
Jun;33(6):189-221.
Pediatric defibrillation and AEDs [guidance article]. 2004 August;33(8): 291-2.

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Health Devices Alerts


This Product Comparison lists Health Devices Alerts (HDA) citations published since the last
update of this report. Each HDA abstract is identified by an Accession Number. Recalls and hazard
reports include descriptions of the problem involved; abstracts of other published articles are
referenced by bibliographic information. HPCS subscribers can call the Hotline for additional
information on any of these citations or to request more extensive searches of the HDA database.

A5496 FDA has designated this Class II Recall No. Z-0356-04 for certain Access CardioSystems
AEDs. The above defibrillators may fail to operate because of a faulty component on the circuit
board. The firm states that the possibility of component failure is very low and depends on use
conditions and notes that no incidents of this failure have been reported with the above units. The
manufacturer initiated a recall by telephone call and e-mail on December 18 and 19, 2003, and by
letter dated December 19, 2003. Verify that you have been contacted by Access CardioSystems.
Identify and remove from service any affected product in your inventory. Source: FDA Enforcement
Rep 2004 Jan 28; Manufacturer.
A5643 (In reference to Action Item Accession No. A4237 dated September 8, 2000 and Action Item
Accession No. A4245 dated September 29, 2000.) FDA has designated this Class II Recall No. Z-
0886-04 for Medtronic LIFEPAK 500 AEDs.The Action Items warned that a limited number of
LIFEPAK 500 defibrillator batteries have an increased risk of battery-cell rupture, which can lead to
staff or patient harm and require repair of the defibrillator before patient use. Medtronic previously
recalled LIFEPAK 500 defibrillator batteries manufactured between September 1998 and April 1999
that had part numbers 3005380-000 through 3005380-006 with battery date codes 9837 through
9920 or part number 3005380-014 with battery date codes 9812 and 9901 through 9905. The
manufacturer has incorporated electrical protection features into the battery design to prevent
similar problems in batteries produced from and after April 2000 and states that this design
modification has proven to be very effective, with no further rupture incidents reported. However,
the firm has received 7 reports of battery-cell rupture involving defibrillator batteries produced
before April 2000 that were not originally recalled. The firm has expanded the recall to include
products with battery date codes below 0013. The manufacturer initiated this recall by letter,
telephone call, and follow-up letter beginning April 2, 2004. Verify that you have received the April
2004 letter or telephone call and follow-up letter from Medtronic. Identify affected product by
removing the battery from the LIFEPAK 500 defibrillator and examining the part number and
battery date code according to the instructions and illustrations included in the letters. If the
battery’s numbers and codes are not in the affected range, the battery may be reinstalled. If the
battery’s numbers and codes are in the affected range, contact Medtronic by telephone to receive a
replacement defibrillator battery. Medtronic will immediately ship the replacement free of charge.
The firm recommends that you leave the affected battery in the defibrillator until the replacement
arrives. After the replacement is installed, turn on the defibrillator to alert the device that a new
battery has been installed. Wait 10 seconds to confirm that the message “Connect Electrodes”
appears. (If any other message appears, contact Medtronic by telephone at the above number for
service.) Turn off the defibrillator. The unit is now ready for use. Return the removed affected
battery to Medtronic using the replacement-battery packaging. Source: FDA Enforcement Rep 2004
May 5; letters submitted by manufacturer.
A5693 FDA has designated this Class II Recall No. Z-0918-04 for certain Welch Allyn AEDs. A faulty
component has been identified in the above defibrillators that could result in an intermittent shock-
button (button number 3) failure. The manufacturer initiated a recall by letter dated April 26, 2004.
The firm would not provide ECRI with any information. Verify that you have received the April 26,
2004 letter from Welch Allyn. Identify and isolate any affected product in your inventory. Source:
FDA Enforcement Rep 2004 May 19.
A5716 FDA has designated this Class II Recall No. Z-0991-04 for certain Cardiac Science AEDs. The
batteries in the AEDs may contain an incorrect fuse, which could open and prevent the AED from
functioning. The manufacturer initiated a recall by letter dated May 10, 2004. Verify that you have
received the May 10, 2004 notification letter, replacement battery, battery installation instructions,

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and shipping box with prepaid postage from Cardiac Science. Identify any affected product in your
inventory. Using the instructions included with the notification letter, replace all affected AED
batteries with the replacement batteries provided by the manufacturer. Source: FDA Enforcement
Rep 2004 Jun 9; Manufacturer.
A5734 FDA has designated this Class II Recall Nos. Z-1033/1034-04 for certain Cardiac Science
AEDs.The AEDs may contain defective or marginal high-voltage capacitors, which may prevent the
device from delivering optimum defibrillation therapy during use. The manufacturer states that the
device’s monthly self-test should alert users to a defective capacitor. If an affected AED fails the self-
test, the AED Rescue-Ready nonvolatile indicator, which is located on the device's upper-right
corner, will turn from green to red. The device will then beep and display “call for service.” However,
the firm adds that a self-test may not detect a defective capacitor. In this case, the AED would take
more time to charge and could fail to provide adequate therapy when needed. The manufacturer
initiated a recall by letter dated June 22, 2004. Verify that you have received the June 22, 2004,
letter, list of affected AED serial numbers, and return authorization number from Cardiac Science.
Using the list of affected AED serial numbers, identify any affected product in your inventory. The
manufacturer will test, repair, and return affected AEDs within 30 days of receipt free of charge.
Source: FDA Enforcement Rep 2004 Jun 30; letter submitted by manufacturer.
A5938 Access CardioSystems automated external defibrillators (AEDs) with serial numbers 075180
through 084760 may exhibit 1 or both of 2 problems: the shock delivery circuit may fail and/or the
AED may turn on unexpectedly. If the shock delivery circuit fails, the AED cannot deliver additional
defibrillation shocks. Additionally, the on/off button may become inoperative after the device turns
on unexpectedly; therefore, the AED may not defibrillate. The malfunctions appear to have risen
from a latent defect in some components. An investigation is ongoing to determine the root cause of
the malfunction. Access CardioSystems is discontinuing the manufacture and support of all its AED
models, is no longer accepting orders for disposable parts, and is ceasing operations. The
manufacturer initiated a recall by letter dated November 3, 2004. Verify that you have received the
November 3, 2004 letter and response form from Access CardioSystems (these materials are also
available online at http://www.accesscardiosystems.com). The manufacturer states that users should
immediately discontinue use of units with the affected serial numbers and remove them from
service. Source: Access CardioSystems. Urgent recall notice—immediate action required: Access
CardioSystems, Inc.’s AccessAED and AccessALS automated external defibrillators [online]. 2004
Nov 3 [cited 2004 Nov 9]. Available from Internet: http://www.accesscardiosystems.com/recall.pdf;
Manufacturer.
A6013 In the referenced Action Item (A5938), it was reported that Access CardioSystems is
discontinuing the manufacture and support of all its automated external defibrillator (AED) models,
is no longer accepting orders for disposable parts, and is ceasing operations. The U.K. Medicines and
Healthcare Products Regulatory Agency (MHRA) has issued a Medical Device Alert and the Irish
Medicines Board (IMB) has issued a Safety Notice informing international users of the recall. The
above AEDs with serial numbers 075180 through 084760 may exhibit 1 or both of 2 problems: the
shock delivery circuit may fail and/or the AED may turn on unexpectedly. If the shock delivery
circuit fails, the AED cannot deliver additional defibrillation shocks. Additionally, the on/off button
may become inoperative after the device turns on unexpectedly; therefore, the AED may not
defibrillate. Identify and isolate any affected product in your inventory. MHRA and IMB recommend
that all affected AEDs be removed from service and replaced with alternative AEDs. Source: Great
Britain. Medicines and Healthcare Products Regulatory Agency. Access AED, Access PAD, and
Access ALS defibrillators manufactured by Access Cardiosystems Inc. London: Department of
Health; 2004 Nov 23. 4 p. (Medical device alert; no. MDA/2004/051); Ireland. Irish Medicines Board.
AccessAED PAD, AccessAED and AccessALS automated external defibrillator devices. Dublin:
Department of Health; 2004 Nov 26. 3 p. (Safety notice; no. SN2004[10]).
A6018 FDA has designated this Class II Recall No. Z-1472-04 for ZOLL M Series AEDs. Under
certain conditions, a software defect in the AEDs can cause the device to skip the “Press Shock”
prompt after correctly advising the user of a shockable electrocardiogram rhythm, charging, and
enabling/illuminating the shock button. ZOLL states that the AED indicates that it is ready to

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Defibrillators, External, Automated; Semiautomated

discharge but skips the visual screen display and audible “Press Shock” prompt. Under these
circumstances, the AED will properly analyze the patient’s rhythm and prompt the user regarding
the analysis outcome (“Shock Advised” or “No Shock Advised”). Users can deliver treatment by
pressing the shock button. ZOLL states that the “Press Shock” display and audible prompt are
redundant indications of the AED’s status. The firm adds that rescuers typically know that the
device is charged and ready for discharge when the shock button is illuminated and the ready tone is
sounding. Affected AEDs have been in clinical use since October 2001, and to date, ZOLL has
received only 1 report that may be related to this issue. The manufacturer initiated a recall by letter
dated July 27, 2004. Verify that you have received the July 27, 2004, letter and software update
request form from ZOLL. Identify any affected product in your inventory. The firm states that
although it believes that users likely will not notice that the screen prompt and audible prompt are
missing while using the AED and will operate it correctly, ZOLL will provide users with corrected
software if they choose. Only M Series units equipped with the AED feature are affected. Affected
units have a main switch labeled “On” and “Off” or “On,” “Off,” and “Pace.” Units with switches
labeled “Defib,” “Monitor,” and “Off” and “Defib,” “Monitor,” “Pace,” and “Off” are not affected. To
check the software version of your AEDs: (1) Turn the unit on, and note the software version number
displayed in the lower right-hand corner of the display during the self-test, which occurs when the
unit is turned on. (2) If you have 1 of the affected software versions listed above, advise users of the
problem. (3) Instruct users that if the device issues the “Shock Advised” prompt followed by the
charge-ready tone and illumination of the shock button, the shock button should be pressed to
deliver patient treatment. Source: FDA Enforcement Rep 2004 Sep 22; letter submitted by
manufacturer.
A6154 FDA has designated this action Class II Recall Nos. Z-0398/0399-05 for certain Cardiac
Science AEDs. Delivery of the first defibrillation shock in the 3-shock sequence in the AEDs may be
delayed because of charge noise from a defective electronic component. Cardiac Science states that
this charge noise occurs in limited circumstances when the device is placed on a conductive surface.
The manufacturer adds that all U.S. customers have been notified of the action, that the field
correction is 95% complete in the U.S., and that it has received no reports of patient injury or death
related to this issue. The firm initiated a field correction by telephone call on November 12, 2004.
Verify that you have been contacted by Cardiac Science or your distributor. Identify any affected
product in your inventory. The manufacturer recommends that you continue to use the AEDs until
you have received the field correction for affected devices. Source: FDA Enforcement Rep 2005 Feb
16; Manufacturer.
A6186 FDA has designated this recall Class I for Medtronic LIFEPAK 500 AEDs. The AEDs may
display the “connect electrodes” message and fail to analyze the patient’s heart rhythm even if they
are properly attached to the patient, potentially inhibiting therapy if it becomes necessary.
Medtronic has received 54 reports of such incidents; 8 of these incidents could have prevented
patient resuscitation. The manufacturer adds that the affected 1,924 first-generation, monophasic
LIFEPAK 500 AEDs represent an estimated 1% of the LIFEPAK 500 AEDs used worldwide. While
actual field reports account for <1% of patient uses, a theoretical engineering analysis estimates that
this problem may occur in up to 8% of patients. The firm initiated a recall by certified letter dated
February 3, 2005. Verify that you have received the February 3, 2005, certified letter from
Medtronic. Identify any affected product in your inventory. Medtronic is contacting affected
customers to offer advice on using the above AEDs and to schedule replacement of affected product.
The manufacturer states that it will update or replace the above AEDs by March 31, 2005. Until you
receive an update or replacement, the firm recommends that you leave affected product in service.
Source: Medtronic. Medtronic announces voluntary recall of certain monophasic LIFEPAK 500
automated external defibrillators (AEDs) [press release online]. 2005 Feb 25 [cited 2005 Mar 1].
Available from Internet: http://www.medtronic-ers.com/500/; United States. Food and Drug
Administration. Center for Devices and Radiological Health. Medtronic announces voluntary recall
of certain monophasic LIFEPAK 500 automated external defibrillators [press release online]. 2005
Jan 25 [cited 2005 Mar 1]. Available from Internet:
http://www.fda.gov/oc/po/firmrecalls/lifepak02_05.html.

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Defibrillators, External, Automated; Semiautomated

A6239 Source: United States. Food and Drug Administration. Center for Devices and Radiological
Health. Recall—firm press release: Heartsine Technologies, Inc. issues worldwide recall of certain
automatic external defibrillators [online]. 2005 Mar 18 [cited 2005 Mar 23]. Available from Internet:
http://www.fda.gov/oc/po/firmrecalls/heartsine03_05.html.
A6243 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a
Medical Device Alert warning healthcare workers that Medtronic LIFEPAK 500 AEDs may not
recognize a connection between their electrodes and the patient, potentially impeding analysis and
inhibiting therapy if it becomes necessary. In such situations, affected devices display a “connect
electrodes” message even if they are properly attached to the patient. This problem appears to occur
when patient impedance is at the low end of the AED’s range, which is 30 to 300 Ω according to
device specifications. MHRA recommends the following: (1) Notify all AED users at your facility of
this issue; (2) identify and isolate any affected product in your inventory by comparing your AED
serial numbers with the list of affected serial numbers (available online at MHRA’s Web site at
http://www.mhra.gov.uk or at the manufacturer’s Web site at http://www.medtronic-ers.com/500). If
you possess affected AEDs and do not have alternative models, the manufacturer recommends that
you continue to use the affected AEDs; (3) contact the manufacturer to schedule replacement of
affected product. Source: Great Britain. Medicines and Healthcare Products Regulatory Agency.
Medtronic LIFEPAK 500 monophasic automated external defibrillator manufactured from March to
May 1997. London: Department of Health; 2005 Mar 23. 3 p. (Medical device alert; no.
MDA/2005/020).
A6306 The Australian distributor initiated a recall by safety alert and letter dated February 18,
2005. The U.S. distributor initiated a recall by press release and Urgent Device Recall Notification
letter dated April 28, 2005. FDA has designated this recall Class I Recall No. Z-0805-05 for certain
Laerdal defibrillator adapter cables. The Australian Therapeutic Goods Administration recently
received 2 reports of patient death after defibrillation failure during use of Heartstart 4000
defibrillators with Heartstart 3000 electrode pads. After testing of the above defibrillators and pads
for malfunctions, the manufacturer determined that the problem was caused by breakage of an
adapter cable from “wear and tear”; the cable was being used to make the defibrillator and pads
compatible. Although both the above defibrillators and the above electrodes function correctly and
are not subject to this recall, the preshift checking procedures described in the Heartstart 4000
defibrillator owner’s manual are not suitable for checking the system when it is equipped with an
adapter cable and will not alert the user to a broken adapter cable. Laerdal confirms that the above
cables manufactured and distributed in the U.S. and other parts of the world are subject to the same
problems. For U.S. customers, verify that you have received the April 28, 2005, Urgent Device Recall
Notification letter, “Supplemental Information—Questions and Answers” sheet, receipt
acknowledgment notification, and customer ship history/acknowledgment form from Laerdal and the
firm’s recall contractor, NNC Group. For Australian customers, verify that you have received the
February 18, 2005, safety alert and/or Recall for Product Correction letter and “Not for Clinical Use”
labels from Laerdal. (Note: Customers in other countries will have received notices from the Laerdal
divisions within their respective countries.) Identify, isolate, and immediately discontinue clinical
use of any affected product in your inventory. Source: Australia. Therapeutic Goods Administration.
Recall for product correction of Laerdal patient cable adapters (Laerdal cat # 920650). TGA News
2005 Apr; No. 46; FDA Enforcement Rep 2005 May 18; letter submitted by U.S. distributor.
A6361 FDA has designated this recall Class I Recall No. Z-0806-05 for certain Welch Allyn MRL
automated external defibrillators (AEDs). These units may fail to analyze the patient’s
electrocardiogram and deliver appropriate therapy, possibly delaying treatment and/or resuscitation
and activating the “Defib Comm” error message. The manufacturer has determined that the failure
is caused by radio-frequency interference that is generated inside the defibrillators by an
intermittent electrical short circuit between the connector and the external housing of the device.
The electrical short circuit is created when an impact to the exterior of the defibrillator causes the
circuit board connector to perforate an insulation shield. The manufacturer states that the problem
arises only when the above combination of factors necessary to cause electrical short circuits occurs.
The firm has received 12 complaints related to this problem, including 1 report in which the failure

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may have prevented resuscitation. The manufacturer initiated a recall by Urgent Medical Device
Recall letter dated April 28, 2005. If you have any of these devices, verify that you have received the
April 28, 2005, Urgent Medical Device Recall letter and response form from Welch Allyn MRL.
Identify any affected product in your inventory by locating the serial and part numbers on the lower
right corner of the back panel of the defibrillator. Source: Letter submitted by manufacturer; United
States. Food and Drug Administration. Center for Devices and Radiological Health. Medical device
recalls. Class I recall: Welch Allyn Co., AED 20®, automatic external defibrillator [online]. 2005 May
13 [cited 2005 May 16]. Available from Internet: http://www.fda.gov/cdrh/recalls/recall-042805.html;
United States. Food and Drug Administration. Center for Devices and Radiological Health. MRL,
Inc. a Welch Allyn company issues a voluntary worldwide recall of selected AED20 automatic
external defibrillators [press release online]. 2005 May 12 [cited 2005 May 16]. Available from
Internet: http://www.fda.gov/oc/po/firmrecalls/mrl05_05.html; FDA Enforcement Rep 2005 May 18.
A6436 The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a
Medical Device Alert warning for certain Laerdal Medical adapter cables that may fail and prevent
defibrillation. MHRA has received 2 reports of patient death in Australia in which broken adapter
cables exhibiting “wear and tear” prevented the defibrillators from delivering a shock. Further
investigation showed that the adapter cables were not included in the preshift checking procedures
when a 50 Ω test load was used and were therefore not tested before the device was used. The
manufacturer initiated a recall to U.K. customers by Advisory Notice 2005-R-01 dated April 18,
2005. For more information about the manufacturer-initiated worldwide recall, see Action Item
Accession No. A6306 dated May 27, 2005. Verify that you have received the April 18, 2005, advisory
notice and return form from Laerdal; the letter and form are also available as an appendix to MHRA
Medical Device Alert No. MDA/2005/032. Identify, isolate, and immediately discontinue clinical use
of any affected product in your inventory. Laerdal states that the above cables are now intended for
training purposes only. If you do not intend to use the device for training purposes, immediately
discard the cables and record the number of discarded cables on the return form. If your facility
chooses to keep the adapter cables for training purposes, clearly label them “NOT FOR CLINICAL
USE” and record the number of labeled cables on the return form. Source: Great Britain. Medicines
and Healthcare Products Regulatory Agency. Defibrillator—Laerdal adaptor cable, product code
920650. London.

Healthcare Risk Control


Automated External Defibrillators [risk analysis]. 2002 Nov; Suppl A: Emergency Care 11.
Automated External Defibrillator Purchase Considerations. 2002 Nov; Suppl A: Emergency Care
11.1.
Defibrillator Failures [risk analysis]. 1996 Jan; Vol 3: Medical Technology 13.
Emergency Department Liability [risk analysis]. 1996 Jan; Vol 4: Emergency Care 1.

Health Technology Forecast


Automated external defibrillators. 2004 Jan.

Supplier information
Burdick
Burdick Inc, A Quinton Co [105481]
500 Burdick Pkwy
Deerfield, WI 53531
Phone: (608) 764-7179 (800) 777-1777 Fax: (608) 764-7188
Internet: http://www.burdick.com
E-mail: info@burdick.com

©ECRI. All Rights Reserved.


18
Defibrillators, External, Automated; Semiautomated

Cardiac Science
Cardiac Science Inc [344498]
1900 Main St Suite 700
Irvine, CA 92614-7317
Phone: (949) 797-3800 (888) 274-3342 Fax: (949) 951-7315
Internet: http://www.cardiacscience.com
E-mail: rcohen@cardiacscience.com
Defibtech
Defibtech LLC [435457]
753 Boston Post Rd Suite 102
Guilford, CT 06437
Phone: (203) 453-6654 (866) 333-4248 Fax: (203) 453-6657
Internet: http://www.defibtech.com
Email: sales@defibtech.com
HeartSine
HeartSine Technologies Inc [412550]
940 Calle Amanecer Suite E
San Clemente, CA 92673
Phone: (949) 218-0092 (866) 478-7463 Fax: (949) 218-0093
Internet: http://www.heartsine.com
E-mail: info@heartsine.com

HeartSine Technologies Ltd [412551]


Canberra House 203 Airport Road West
Northern Ireland
Phone: 44 (2890) 939400 Fax: 44 (2890) 939401
Internet: http://www.heartsine.com
E-mail: sales@heartsine.com
Medtronic
Medtronic Emergency Response Systems [440781]
11811 Willows Rd NE PO Box 97006
Redmond, WA 98073-9706
Phone: (425) 867-4000 (800) 442-1142 Fax: (425) 867-4121
Internet: http://www.medtronic-ers.com

Medtronic Emergency Response Systems (Asia Pacific) [440800]


Level 9 Forsyth Barr House Corner Armagh and Colombo Street
Christchurch 1
New Zealand
Phone: 64 (3) 3794429 Fax: 64 (3) 3792374
Internet: http://www.medtronic-ers.com

Medtronic Emergency Response Systems (France) [440796]


122 avenue du General Leclerc
F-92514 Boulogne-Billancourt Cedex
France
Phone: 33 (1) 55381700 Fax: 33 (1) 55381800
Internet: http://www.medtronic-ers.com

Medtronic Emergency Response Systems (UK) [440786]


Suite One Sherbourne House Croxley Business Park
Watford Hertfordshire WD18 8WW
England
Phone: 44 (1923) 212213 Fax: 44 (1923) 241004
Internet: http://www.medtronic-ers.com

©ECRI. All Rights Reserved.


19
Defibrillators, External, Automated; Semiautomated

Metrax
Metrax GmbH [172393]
Reinwaldstrasse 22
D-78682 Rottweil
Germany
Phone: 49 (741) 2570 Fax: 49 (741) 257235
Internet: http://www.primedic.de
E-mail: metrax.vertrieb@metrax.de
Philips Medical Systems
Philips Medical Systems, Cardiac & Monitoring Systems Div [397917]
3000 Minuteman Rd Mailstop 101
Andover, MA 01810
Phone: (978) 687-1501 (800) 934-7372 Fax: (800) 947-3299
Internet: http://www.medical.philips.com

Philips Medical Systems (Asia Pacific), Cardiac & Monitoring Systems Div [398048]
24/Fl Cityplaza One 1111 King's Road
Taikoo Shing
People's Republic of China
Phone: 852 31977777 Fax: 852 25069261
Internet: http://www.medical.philips.com

Philips Medical Systems (Europe), Cardiac & Monitoring Systems Div [398047]
Herrenberger Strasse 124
D-71034 Boeblingen
Germany
Phone: 49 (7031) 4641552 Fax: 49 (7031) 4644096
Internet: http://www.medical.philips.com
E-mail: pmscc@philips.com
Progetti
Progetti srl [272310]
via Bruno Buozzi 28
I-10024 Moncalieri TO
Italy
Phone: 39 (011) 644738 Fax: 39 (011) 645822
Internet: http://www.progettimedical.com
E-mail: info@progettimedical.com
Schiller
Schiller AG [162079]
Altgasse 68
CH-6341 Baar
Switzerland
Phone: 41 (41) 7664242 Fax: 41 (41) 7610880
Internet: http://www.schiller.ch
E-mail: sales@schiller.ch

Schiller America Inc [108674]


11300 NW 41st St
Miami, FL 33178
Phone: (786) 845-0620 (888) 845-8455 Fax: (786) 845-0602
Internet: http://www.schiller.com
E-mail: sales@schilleramerica.com

Schiller Medical SAS [401027]


4 rue Louis Pasteur
F-67162 Wissembourg

©ECRI. All Rights Reserved.


20
Defibrillators, External, Automated; Semiautomated

France
Phone: 33 (3) 88633600 Fax: 33 (3) 88941282
Internet: http://www.schiller-medical.com
E-mail: info@schiller.fr
Welch Allyn
Welch Allyn Inc [101850]
4341 State Street Rd PO Box 220
Skaneateles Falls, NY 13153-0220
Phone: (315) 685-4100 (800) 535-6663 Fax: (315) 685-4091
Internet: http://www.welchallyn.com
E-mail: info@mail.welchallyn.com

Welch Allyn International Venture Inc [319405]


10 Hoe Chiang Road #19-03 Keppel Towers
Singapore 089315
Republic of Singapore
Phone: 65 62910882
Internet: http://www.welchallyn.com
E-mail: info@welchallyn.com

Welch Allyn UK Ltd [319406]


Cublington Road
Aston Abbotts Buckinghamshire HP22 4ND
England
Phone: 44 (207) 3656780 Fax: 44 (207) 3659694
Internet: http://www.welchallyn.com
E-mail: sales@welchallyn.com
ZOLL
ZOLL Medical Australia Pty Ltd [340577]
81 Excelsior Street
Lisarow NSW 2250
Australia
Phone: 61 (2) 94208733 Fax: 61 (2) 43292226
Internet: http://www.zoll.com
E-mail: gdousset@zoll.com.au

ZOLL Medical Corp [150032]


269 Mill Rd
Chelmsford, MA 01824
Phone: (978) 421-9655 (800) 348-9011 Fax: (978) 421-0025
Internet: http://www.zoll.com
E-mail: info@zoll.com

ZOLL Medical Deutschland [406734]


Gmb N Schillingsrotter Strasse 23
D-50996 Koeln
Germany
Phone: 49 (2241) 945855 Fax: 49 (2241) 945857
Internet: http://www.zoll.com
E-mail: sbraever@zollgermany.de

ZOLL Medical UK Ltd [340608]


49 Melford Court Harwick Grange Woolston
Warrington Chesire WAI 4RZ
England
Phone: 44 (1925) 846400 Fax: 44 (1925) 846401
Internet: http://www.zoll.com
E-mail: info@zoll.com

©ECRI. All Rights Reserved.


21
Defibrillators, External, Automated; Semiautomated

About the chart specifications


The following terms are used in the chart:
Protocol configured: Some of the units allow the purchaser to dictate, to some extent, the protocol
— that is, the sequence of prompts and energy level provided by the unit.
Output waveshape: Monophasic (damped) sinusoidal (see Geddes and Havel 2000 in Bibliography).
Gain, mm/mV: Determines the amplitude of the electrocardiogram waveform displayed; it is
measured in millimeters per millivolt.
V tach rate threshold, bpm: The heart rate above which the unit will shock ventricular tachycardia.
VF amplitude threshold, mV: The amplitude below which the unit will not shock ventricular
fibrillation. The threshold depends on the rate and the waveform characteristics.
Event record database storage: Some units allow data from each resuscitation attempt to be
downloaded to a database for long-term storage and trending.
Abbreviations:
AAMI — Association for the Advancement of
Medical Instrumentation LCD — Liquid crystal display
AED — Automated external defibrillator LED — Light-emitting diode
ALS — Advanced life support MDD — Medical Devices Directive
bpm — Beats per minute Ni-Cd — Nickel-cadmium
CE mark — Conformite Europeene mark Ni-MH — Nickel metal hydride
CPR — Cardiopulmonary resuscitation PC — Personal computer
CRT — Cathode ray tube PCMCIA — Personal Computer Memory Card
CSA — Canadian Standards Association International Association
ECG — Electrocardiogram RAM — Random-access memory
FDA — U.S. Food and Drug Administration SLA — Sealed lead-acid
IBP — Invasive blood pressure UL — Underwriters Laboratories
IEC — International Electrotechnical VF — Ventricular fibrillation
Commission VT — Ventricular tachycardia

Note: The data in the charts derive from suppliers’ specifications and have not been verified
through independent testing by ECRI or any other agency. Because test methods vary, different
products’ specifications are not always comparable. Moreover, products and specifications are subject
to frequent changes. ECRI is not responsible for the quality or validity of the information presented
or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect
supplier discounts. And although we try to indicate which features and characteristics are standard
and which are not, some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have
also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in
mind that exchange rates change often.

Need to know more?


For further information about the contents of this Product Comparison, contact the HPCS Hotline
at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or hpcs@ecri.org (e-mail).

©ECRI. All Rights Reserved.


22
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart

©ECRI. All Rights Reserved.


23
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED BURDICK BURDICK
SPECIFICATIONS1 SPECIFICATIONS1
Standard AED Public-Access Defibrillator CardioVive AT CardioVive DM
(PAD)
WHERE MARKETED Worldwide Worldwide
FDA CLEARANCE Yes Yes
CE MARK (MDD) Yes Yes
STANDARD AED or PAD Not specified Not specified
DEFIBRILLATOR
Type Fully or semiautomatic Fully or semiautomatic Automated Automated
Manual override Optional Optional Not specified Yes
Voice prompting Yes Yes Yes Yes
Number of prompts No preference No preference 10 10
Energy sequence, AED Any Any Variable Variable
mode, J
Energy settings, Any Any 50-360 50-360
manual mode, J
Protocol configured Yes Yes
Output waveshape Biphasic preferred Biphasic preferred Biphasic truncated Biphasic truncated
exponential exponential
MONITOR
ECG acquisition Electrodes Electrodes
Monitor with ECG Not specified Yes
electrodes
ECG display
Type Optional; no preference No LCD (through PC LCD (through PC
interface) interface)
Message display
Type LCD LCD
Heart rate display Optional No Yes Yes
Gain, mm/mV Any Any Not specified Yes
ELECTRODES Any Any Not specified Not specified
Conductive area >50/>15 cm² (peds) >50/>15 cm² (peds) Full electrode Full electrode
Shelf life >12 months >12 months 2 years 2 years
List price (pair) Not specified Not specified
ANALYSIS
Auto or manual Auto Auto Auto Auto and/or manual
Segment analyzed, sec No preference No preference 14 14
Analysis time, sec <15 <15 Not specified Not specified
V tach rate threshold, Any Any User selectable User selectable
bpm
VF amplitude Any Any 0.08 0.08
threshold, mV
SELF TEST
Frequency Not specified Not specified
Energy level, J Not specified Not specified
CHARGE TIME
From shock advised, Not specified Not specified
sec
Shock-to-shock, sec Not specified Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


24
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED BURDICK BURDICK
SPECIFICATIONS1 SPECIFICATIONS1
Standard AED Public-Access Defibrillator CardioVive AT CardioVive DM
(PAD)
DOCUMENTATION
Chart recorder Optional Optional Printed from PC Printed from PC
ECG/voice recording Yes/optional Yes/optional ECG ECG
Capacity, min >15 >15 Not specified Not specified
Playback Any Any Yes Yes
DATA STORAGE
Solid-state memory Any Any Yes Yes
Information stored ECG, shocks ECG, shocks ECG, recommended ECG, recommended
shock, time, date, rhythm, shock, time, date, rhythm,
others others
Capacity, min >15 >15 Not specified Not specified
Playback Any Any RescueLink software, full- RescueLink software, full-
disclosure playback disclosure playback
Event record database Yes Yes Yes Yes
storage
Data management No preference No preference RescueLink RescueLink
software
BATTERY TYPE No preference No preference Lithium (extended life) Lithium (extended life)
Integral/removable Removable Removable Removable Removable
Charging method Nonrechargeable Nonrechargeable Not specified Not specified
preferred preferred
Charge time, hr NA NA
Operating time >30 discharges or 2 hr >30 discharges or 2 hr 260 shocks at 360 J 260 shocks at 360 J
continuous ECG continuous ECG
monitoring monitoring
AC POWER Optional Optional NA NA
H x W x D, cm (in) 8.4 x 26.9 x 31.5 (3.3 x 8.4 x 26.9 x 31.5 (3.3 x
10.6 x 12.4) 10.6 x 12.4)
WEIGHT, kg (lb) <4.5 (10) <4.5 (10) 3.5 (7.7) 3.5 (7.7)
PURCHASE
INFORMATION
List price
Unit Not specified Not specified
Charger Not specified Optional
Replacement batt Not specified Not specified
Load simulator Not specified Not specified
Memory modules Not specified Not specified
Warranty 5 years, parts and labor 5 years, parts and labor
Delivery time, ARO Not specified Not specified
Year first sold Not specified Not specified
OTHER RescueReady reliability; RescueReady reliability;
SPECIFICATIONS daily self-tests confirm daily self-tests confirm
that battery, internal that battery, internal
circuitry, and circuitry, and
preconnected electrodes preconnected electrodes
are fully functional. are fully functional.
1 1
Supplier Footnotes These recommendations These recommendations
are the opinions of ECRI's are the opinions of ECRI's
technology experts. ECRI technology experts. ECRI
assumes no liability for assumes no liability for
decisions made based on decisions made based on
this data. this data.
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


25
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE
Powerheart AED G3 Powerheart AED G3 Powerheart AED G3 Pro Powerheart Cardiac
Automatic Rhythm Module (CRM)
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD PAD PAD Standard AED CRM
DEFIBRILLATOR
Type Semiautomatic Fully automatic Semiautomatic with Automatic continuous
manual override monitoring or
semiautomatic
Manual override No No No Yes
Voice prompting Yes Yes Yes Yes
Number of prompts 20 23 27 7
Energy sequence, AED 200, 300, 300 200, 300, 300 200, 300, 300 Auto and advisory per
mode, J physician protocol (5-270
J), AED fixed at 200, 200,
270
Energy settings, NA NA 200, 300, 300 5-270
manual mode, J
Protocol configured Yes Yes Yes Yes
Output waveshape Biphasic truncated Biphasic truncated Biphasic truncated Biphasic truncated
exponential exponential exponential exponential
MONITOR
ECG acquisition Defib electrodes Defib electrodes Defib or monitoring Defib electrode pads or
electrodes ECG monitoring
electrodes
Monitor with ECG No No Yes Yes
electrodes
ECG display
Type NA NA Full color, transflective, STN color, 240 x 320
320 x 240 pixels pixels
Message display
Type Text Text 8.9 cm diagonal 9.7 cm diagonal
Heart rate display No No Yes Yes
Gain, mm/mV NA NA NA Not scaled
ELECTRODES Hydro gel Hydro gel Hydro gel Disposable with gel
Conductive area 228 cm² 228 cm² 228 cm² 164 cm²
Shelf life 2 years 2 years 2 years 1 year
List price (pair) $43.95 $43.95 $43.95 $39.95
ANALYSIS
Auto or manual Auto Auto Auto Auto/advisory/manual;
AED, ECG monitoring,
external temp, and pacing
are on demand and
asynchronous
Segment analyzed, sec Continuous Continuous Continuous Continuous
Analysis time, sec 9 9 9 Continuous
V tach rate threshold, 120-240, user selectable 120-240, user selectable 120-240, user selectable 120-240, user selectable
bpm
VF amplitude 0.08 0.08 0.08 0.2
threshold, mV
SELF TEST
Frequency Daily, weekly, monthly Daily, weekly, monthly Daily, weekly, monthly At power-on and
continuously when on
Energy level, J Partial (weekly), full Partial (weekly), full Partial (weekly), full Not specified
(monthly) (monthly) (monthly)
CHARGE TIME
From shock advised, 9 (for analysis) 9 (for analysis) 9 (for analysis) Continuous
sec
Shock-to-shock, sec 3 shocks in 55 sec 3 shocks in 55 sec 3 shocks in 55 sec 10

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


26
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE
Powerheart AED G3 Powerheart AED G3 Powerheart AED G3 Pro Powerheart Cardiac
Automatic Rhythm Module (CRM)
DOCUMENTATION
Chart recorder No No No No
ECG/voice recording No No No No
Capacity, min NA NA NA NA
Playback NA NA NA NA
DATA STORAGE
Solid-state memory Internal Internal Internal Nonvolatile RAM
Information stored Time/date stamp, ECG Time/date stamp, ECG Time/date stamp, ECG FR stores 6 events (each
event can contain up to 6
shocks)
Capacity, min 60 (ECG only) 60 (ECG only) 60 (ECG only) 48 (8 min/event)
Playback RescueLink software to RescueLink software to RescueLink software to Data downloaded and
PC PC PC reviewed on PC
Event record database Yes Yes Yes Yes
storage
Data management RescueLink RescueLink RescueLink Event Review Software Kit
software
BATTERY TYPE Lithium (extended life) Lithium (extended life) Lithium (extended life) SLA
Integral/removable Removable Removable Removable Integral
Charging method Disposable Disposable Disposable, optional Line cord
rechargeable
Charge time, hr NA NA 4.5 for completely 10 maximum
depleted battery
Operating time Up to 290 shocks Up to 290 shocks Up to 290 shocks or 12 hr 3 hr monitoring/2 hr
of use, rechargeable lasts pacing with new and fully
for 100 shocks or 6 hr of charged battery, 30 Emax
monitoring shocks
AC POWER No No No Yes
H x W x D, cm (in) 8.4 x 26.9 x 31.5 (3.3 x 8.4 x 26.9 x 31.5 (3.3 x 8.4 x 26.9 x 31.5 (3.3 x 25.4 x 11.2 x 29.2 (10 x
10.6 x 12.4) 10.6 x 12.4) 10.6 x 12.4) 4.4 x 11.5)
WEIGHT, kg (lb) 3.5 (7.7) 3.5 (7.7) 3.5 (7.7) 5.6 (12.4)
PURCHASE
INFORMATION
List price
Unit $2,495 $2,495 $3,995 $6,500
Charger NA NA Not specified NA
Replacement batt $395 $395 $395 $199
Load simulator $400 $400 $400 $699
Memory modules NA NA NA Not specified
Warranty 7 years, excluding 7 years, excluding 7 years, excluding 1.5 years
electrodes/battery electrodes/battery electrodes/battery
Delivery time, ARO Ships within 24 hr Ships within 24 hr Ships within 24 hr Ships within 24 hr
Year first sold 2003 2004 2004 2002
OTHER Semiautomatic AED; Fully automatic AED Semiautomatic with Automatically detects VT,
SPECIFICATIONS RescueReady indicator; eliminates decision manual override VF, and SVT and delivers
nonpolarized electrodes; making for ease of use; functionality; color ECG cardioversion, pacing, or
electrode self-test for RescueReady indicator; display; RescueReady defibrillation or pacing;
presence and nonpolarized electrodes; indicator; ECG monitoring designed for in-hospital
functionality; battery electrode self-test for allows professional user to use.
capacity gauge; 4-year full presence and take control of rescue.
replacement battery; 1- functionality; battery
button operation. capacity gauge; 4-year full
replacement battery.
Supplier Footnotes
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


27
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL DEFIBTECH HEARTSINE HEARTSINE MEDTRONIC
LIFELINE AED Samaritan AED (001 : 002 Samaritan PAD LIFEPAK 500 AED
: 003) ADAPTIV Biphasic
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Not specified Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD AED AED PAD Not specified
DEFIBRILLATOR
Type Semiautomatic Semiautomatic Semiautomatic Semiautomatic
Manual override Not specified Optional No No
Voice prompting Yes Yes Yes Yes
Number of prompts Not specified 38 42 Numerous
Energy sequence, AED 150 100, 150, 200, or as set in 100, 150, 200 200-360 configurable (150
mode, J protocol by country)
Energy settings, Not specified 100, 150, 200, 230 : NA NA
manual mode, J Optional : Optional
Protocol configured Yes Yes Yes Yes
Output waveshape Biphasic truncated Biphasic truncated Biphasic truncated Biphasic truncated
exponential exponential exponential exponential with voltage
and duration
compensation for patient
impedance
MONITOR
ECG acquisition Pads Defibrillation or None Disposable multifunction
monitoring-only electrodes electrodes
: Defibrillation electrodes :
Defibrillation electrodes
Monitor with ECG No Yes : Optional : Optional NA No
electrodes
ECG display
Type No High-resolution backlit NA NA
LCD
Message display No
Type No High-resolution backlit NA LCD
LCD
Heart rate display No Yes NA No
Gain, mm/mV No Autogain NA NA
ELECTRODES Single-use, non-polarized, Solid gel Pads Solid gel
self-adhesive
Conductive area 50 cm² for DDP-200P 100 cm² 100 cm² 82 cm²
(pediatric/infant), 103 cm²
for DDP-100 (adult)
Shelf life Not specified 2 years 3 years 2 years
List price (pair) Not specified $20-32 Included with battery $32
ANALYSIS
Auto or manual Auto Auto Auto Auto
Segment analyzed, sec Continuous 5 5 2.7
Analysis time, sec Not specified 1-15 1-15 5.4-8.1
V tach rate threshold, Not specified 180 (multiparameter) 181 (multiparameter) >120
bpm
VF amplitude Not specified 150 µV 150 µV >0.08
threshold, mV
SELF TEST
Frequency Daily, weekly, monthly Not specified Not specified Not specified
Energy level, J 150 Not specified Not specified Not specified
CHARGE TIME
From shock advised, <6 Not specified Not specified Not specified
sec
Shock-to-shock, sec <20 Not specified Not specified Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


28
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL DEFIBTECH HEARTSINE HEARTSINE MEDTRONIC
LIFELINE AED Samaritan AED (001 : 002 Samaritan PAD LIFEPAK 500 AED
: 003) ADAPTIV Biphasic
DOCUMENTATION
Chart recorder Optional No No No
ECG/voice recording Yes/no Automatic to removable Continuous ECG Yes/optional
battery
Capacity, min 12 hours of ECG and 60 voice, 12 hr ECG 45 ECG and event data 20-80
events on removable data
card
Playback Downloaded SAVER Windows PC SAVER Windows PC Direct connection to PC,
software software modem connection to PC,
direct print
DATA STORAGE
Solid-state memory Removable data card Integrated in Data Pak Integrated in PAD unit Internal
battery
Information stored ECG, events Continuous ECG, voice, ECG, events time ECG, events, voice, test
event data, device status stamped log
Capacity, min Up to 12 hours 720 45 20-80
Playback Downloaded On PC On PC Data management
software
Event record database Yes Yes Yes Yes
storage
Data management Not specified Yes Yes DT Express/Code-Stat
software Suite
BATTERY TYPE LiMnO2 LiMnO2 (1) LiMnO2 (1) LiMnO2, LiSO2, SLA
Integral/removable Removable Remove/5 yr shelf life Remove/5 yr shelf life Separate
Charging method Disposable Rechargeable and Nonrechargeable Battery charger (SLA only)
nonrechargeable (disposable)
(disposable)
Charge time, hr NA 2 NA 10 to full capacity
Operating time 125 shocks or 8 hours 12 hr ECG monitoring 6 hr or >30 shocks 18 hr monitoring/418
continuous operation minimum, 120 x 200 J discharges, LiMnO2; 14 hr
(Model DBP-1400); 300 shocks (new battery) monitoring/312
shocks or 16 hours discharges, LiSO2; 3 hr
continuous operation monitoring/59 discharges,
(Model DBP-2800) SLA
AC POWER No No No No
H x W x D, cm (in) 22 x 30 x 7 (8.5 x 11.8 x 20.5 x 25.8 x 6 (8.1 x 10.2 20.3 x 17.8 x 5.1 (8 x 7 x 10.2 x 26.7 x 29.5 (4 x
2.7) x 2.4) 2) 10.5 x 11.6)
WEIGHT, kg (lb) 1.9 (4.2) with DBP-1400, 2 1.8 (4) 0.9 (2) 2.4 (5.3)
(4.4) with DBP-2800
PURCHASE
INFORMATION
List price
Unit Not specified $2,995 : $2,795 : $2,695 $1,595, includes carry $3,605
case, 2 Pad-Paks (defib
pads and batteries)
Charger NA $129 NA $161
Replacement batt Not specified $180 $99 $135-210
Load simulator Not specified Not required Not required $76
Memory modules Not specified Integrated into battery Integrated into PAD No
Warranty 1 year 5 years 5 years 5 years
Delivery time, ARO Not specified 30 days 30 days 30 days
Year first sold Not specified 2002 2004 1996
OTHER Pads preconnected tested 1-2-3 operation; large 12.5 1-2-3 operation; large Readiness status display;
SPECIFICATIONS daily; unit and battery cm (5 in) diagonal display; illuminating graphical multiple configurable
pack system test by user; readiness indicator with interface; readiness setup options; splashproof
visual and audible self-tests; rugged indicator with self-tests; IPX4 rated; preconnected
indication of unit status; rubberized case; IPX4 rugged rubberized case; electrodes compatible with
splash proof. splashproof; Intelligent IPX4 splashproof; other LIFEPAK
Battery System; carrying combined electrode and defibrillators.
case and mounting battery pak.
support system optional.
1
Supplier Footnotes These recommendations
are the opinions of ECRI's
technology experts. ECRI
assumes no liability for
decisions made based on
this data.
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


29
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL MEDTRONIC MEDTRONIC METRAX METRAX
LIFEPAK 500 AED LIFEPAK CR Plus HeartSave 6 HeartSave 6S
Monophasic ADAPTIV Biphasic
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes No No
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD Not specified Not specified Advanced AED with Advanced AED with
manual mode and manual mode and
cardioversion cardioversion and SpO2
DEFIBRILLATOR
Type Semiautomatic Semiautomatic or fully Semiautomatic and Semiautomatic and
automatic manual manual
Manual override No No Yes Yes
Voice prompting Yes Yes Yes Yes
Number of prompts Numerous Numerous 38 38
Energy sequence, AED 200-360 configurable (150 200-360 configurable (150 Not specified (low, Not specified (low,
mode, J by country) by country) medium, high) medium, high)
Energy settings, NA NA 50, 100, 200, 300, 360 50, 100, 200, 300, 360
manual mode, J
Protocol configured Yes Yes Low, medium, high Low, medium, high
Output waveshape Monophasic damped sine Biphasic truncated Biphasic Biphasic
(Edmark) exponential
MONITOR
ECG acquisition Disposable multifunction Disposable, QUIK-PAK Multifunction electrodes in Multifunction electrodes in
electrodes multifunction front cover front cover
Monitor with ECG No No Yes Yes
electrodes
ECG display Yes Yes
Type NA NA LCD, blue mode LCD, blue mode
Message display Not specified Not specified
Type LCD NA LCD, blue mode LCD, blue mode
Heart rate display No No 0-30 bpm 0-30 bpm
Gain, mm/mV NA NA NA NA
ELECTRODES Solid gel Solid gel Not specified Not specified
Conductive area 82 cm² 82 cm² 76 cm² per pad 76 cm² per pad
Shelf life 2 years 2 years 2 years 2 years
List price (pair) $32 $80 QUIK-PAK (includes Not specified Not specified
CHARGE-PAK battery
charger and 1 set of
QUIK-PAK electrodes)
ANALYSIS
Auto or manual Auto Auto Auto Auto
Segment analyzed, sec 2.7 2.7 3 3
Analysis time, sec 5.4-8.1 5.4-8.1 7-12 7-12
V tach rate threshold, >120 >120 Not specified Not specified
bpm
VF amplitude >0.08 >0.08 >200 µV >200 µV
threshold, mV
SELF TEST
Frequency Not specified Not specified Daily, monthly, every 6 Daily, monthly, every 6
months months
Energy level, J Not specified Not specified Up to max energy every 6 Up to max energy every 6
months months
CHARGE TIME
From shock advised, Not specified Not specified 12 12
sec
Shock-to-shock, sec Not specified Not specified Not specified Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


30
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL MEDTRONIC MEDTRONIC METRAX METRAX
LIFEPAK 500 AED LIFEPAK CR Plus HeartSave 6 HeartSave 6S
Monophasic ADAPTIV Biphasic
DOCUMENTATION
Chart recorder No No Yes Yes
ECG/voice recording Yes/optional Yes/no Yes Yes
Capacity, min 20-80 20 minimum Up to 24 hr (ECG, event) Up to 24 hr (ECG, event)
Playback Direct connection to PC, Via wireless IrDA port Windows-based data Windows-based data
modem connection to PC, management software management software
direct print
DATA STORAGE
Solid-state memory Internal Internal digital Removable compact Removable compact
Flash card Flash card
Information stored ECG, events, voice, test ECG, events, markers, Continuous ECG, all Continuous ECG, all
log test log events/audio recording events/audio recording
Capacity, min 20-80 20 ECG Up to 12 hr (ECG, event) Up to 12 hr (ECG, event)
Playback Data management Data management Windows-based data Windows-based data
software software management software management software
Event record database Yes 200 time-stamped event- Yes Yes
storage log markers
Data management DT Express/Code-Stat DT Express/Code-Stat Windows Windows
software Suite Suite
BATTERY TYPE LiMnO2, LiSO2, SLA Internal hybrid layer LiMnO2 LiMnO2
capacitor (HLC)
Integral/removable Separate Removable CHARGE- Removable Removable
PAK battery charger
Charging method Battery charger (SLA only) CHARGE-PAK battery NA (disposable) NA (disposable)
charger
Charge time, hr 10 to full capacity NA NA NA
Operating time 18 hr monitoring/418 30 full discharges or 210 110 full-energy shocks or 110 full-energy shocks or
discharges, LiMnO2; 14 hr min of on time w/fully 15 hr continuous 15 hr continuous
monitoring/312 charged device monitoring monitoring
discharges, LiSO2; 3 hr
monitoring/59 discharges,
SLA
AC POWER No No Yes (as power module) Yes (as power module)
H x W x D, cm (in) 10.2 x 26.7 x 29.5 (4 x 10.7 x 20.3 x 24.1 (4.2 x 8 26 x 26 x 9 (10.2 x 10.2 x 26 x 26 x 9 (10.2 x 10.2 x
10.5 x 11.6) x 9.5) 3.5) 3.5)
WEIGHT, kg (lb) 2.8 (6.2) 2 (4.4) 2 (4.4) 2 (4.4)
PURCHASE
INFORMATION
List price
Unit $3,262 $2,785 Not specified Not specified
Charger $161 $80 CHARGE-PAK NA NA
includes CHARGE-PAK
battery charger and 1 set
of QUIK-PAK electrodes
Replacement batt $135-210 See charger Not specified Not specified
Load simulator $76 NA Not specified Not specified
Memory modules No No Not specified Not specified
Warranty 5 years 5 years 2 years 2 years
Delivery time, ARO 30 days 30 days 30 days 30 days
Year first sold 1996 2002 2003 2003
OTHER Multiple configurable Readiness status display; None specified. None specified.
SPECIFICATIONS setup options; splashproof multiple configurable
IPX4 rated; preconnected setup options; splashproof
electrodes compatible with IPX4 rated; preconnected
other LIFEPAK electrodes; compatible
defibrillators. with other LIFEPAK
defibrillators.
Supplier Footnotes
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


31
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL METRAX METRAX METRAX METRAX
HeartSave AED HeartSave AED-M HeartSave AED-T (V) HeartSave AED-T (V+D)
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE No No No No
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD PAD PAD PAD with patented PAD with patented
telemetry system telemetry system
DEFIBRILLATOR
Type Semiautomatic Semiautomatic Semiautomatic Semiautomatic
Manual override No No No No
Voice prompting Yes Yes Yes Yes
Number of prompts 38 38 38 38
Energy sequence, AED Not specified (low, Not specified (low, Not specified (low, Not specified (low,
mode, J medium, high) medium, high) medium, high) medium, high)
Energy settings, NA NA NA NA
manual mode, J
Protocol configured Low, medium, high Low, medium, high Low, medium, high Low, medium, high
Output waveshape Biphasic Biphasic Biphasic Biphasic
MONITOR
ECG acquisition Multifunction electrodes in Multifunction electrodes in Multifunction electrodes in Multifunction electrodes in
front cover front cover front cover front cover
Monitor with ECG No Yes Yes Yes
electrodes
ECG display No Yes No No
Type NA LCD, blue mode NA NA
Message display NA Not specified Not specified Not specified
Type NA LCD, blue mode LCD, blue mode LCD, blue mode
Heart rate display Digital, 0-30 bpm 0-30 bpm 0-30 bpm 0-30 bpm
Gain, mm/mV NA NA NA NA
ELECTRODES Not specified Not specified Not specified Not specified
Conductive area 76 cm² per pad 76 cm² per pad 76 cm² per pad 76 cm² per pad
Shelf life 2 years 2 years 2 years 2 years
List price (pair) Not specified Not specified Not specified Not specified
ANALYSIS
Auto or manual Auto Auto Auto Auto
Segment analyzed, sec 3 3 3 3
Analysis time, sec 7-12 7-12 7-12 7-12
V tach rate threshold, Not specified Not specified Not specified Not specified
bpm
VF amplitude >200 µV >200 µV >200 µV >200 µV
threshold, mV
SELF TEST
Frequency Daily, monthly, every 6 Daily, monthly, every 6 Daily, monthly, every 6 Daily, monthly, every 6
months months months months
Energy level, J Up to max energy every 6 Up to max energy every 6 Up to max energy every 6 Up to max energy every 6
months months months months
CHARGE TIME
From shock advised, 12 12 12 12
sec
Shock-to-shock, sec Not specified Not specified Not specified Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


32
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL METRAX METRAX METRAX METRAX
HeartSave AED HeartSave AED-M HeartSave AED-T (V) HeartSave AED-T (V+D)
DOCUMENTATION
Chart recorder Yes Yes Yes Yes
ECG/voice recording Yes Yes Yes Yes
Capacity, min Up to 24 hr (ECG, event) Up to 24 hr (ECG, event) Up to 24 hr (ECG, event) Up to 24 hr (ECG, event)
Playback Windows-based data Windows-based data Windows-based data Windows-based data
management software management software management software management software
DATA STORAGE
Solid-state memory Removable compact Removable compact Removable compact Removable compact
Flash card Flash card Flash card Flash card
Information stored Continuous ECG, all Continuous ECG, all Continuous ECG, all Continuous ECG, all
events/audio recording events/audio recording events/audio recording events/audio recording
Capacity, min Up to 12 hr (ECG, event) Up to 12 hr (ECG, event) Up to 12 hr (ECG, event) Up to 12 hr (ECG, event)
Playback Windows-based data Windows-based data Windows-based data Windows-based data
management software management software management software management software
Event record database Yes Yes Yes Yes
storage
Data management Windows Windows Windows Windows
software
BATTERY TYPE LiMnO2 LiMnO2 LiMnO2 LiMnO2
Integral/removable Removable Removable Removable Removable
Charging method NA (disposable) NA (disposable) NA (disposable) NA (disposable)
Charge time, hr NA NA NA NA
Operating time 110 full-energy shocks or 110 full-energy shocks or 110 full-energy shocks or 110 full-energy shocks or
15 hr continuous 15 hr continuous 15 hr continuous 15 hr continuous
monitoring monitoring monitoring monitoring
AC POWER Yes (as power module) Yes (as power module) Yes (as power module) Yes (as power module)
H x W x D, cm (in) 26 x 26 x 9 (10.2 x 10.2 x 26 x 26 x 9 (10.2 x 10.2 x 26 x 26 x 9 (10.2 x 10.2 x 26 x 26 x 9 (10.2 x 10.2 x
3.5) 3.5) 3.5) 3.5)
WEIGHT, kg (lb) 2 (4.4) 2 (4.4) 2 (4.4) 2 (4.4)
PURCHASE
INFORMATION
List price
Unit Not specified Not specified Not specified Not specified
Charger NA NA NA NA
Replacement batt Not specified Not specified Not specified Not specified
Load simulator Not specified Not specified Not specified Not specified
Memory modules Not specified Not specified Not specified Not specified
Warranty 2 years 2 years 2 years 2 years
Delivery time, ARO 30 days 30 days 30 days 30 days
Year first sold 2003 2003 2003 2003
OTHER None specified. None specified. None specified. None specified.
SPECIFICATIONS
Supplier Footnotes
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


33
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL PHILIPS MEDICAL PHILIPS MEDICAL PHILIPS MEDICAL PROGETTI
SYSTEMS SYSTEMS SYSTEMS
HeartStart FR2+ M3860A HeartStart FRx HeartStart OnSite PG DEF
: M3861A M5066A
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes, including sale w/o Yes
prescription
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD AED Both PAD AED
DEFIBRILLATOR
Type Semiautomatic Semiautomatic Semiautomatic Semiautomatic
Manual override Optional No No Yes
Voice prompting Yes Yes Yes Yes
Number of prompts 36 71 including CPR 71 including CPR Not specified
coaching coaching
Energy sequence, AED 150 fixed 150 fixed 150 fixed Escalating, 110-200
mode, J
Energy settings, 150 NA NA Escalating, 110-230
manual mode, J
Protocol configured With training/admin pack With Event Review With Event Review 100, 150, 200, 230
software & HeartStart software & HeartStart
Configure Palm handheld Configure Palm handheld
software software
Output waveshape Biphasic truncated Biphasic truncated Biphasic truncated Biphasic truncated
exponential exponential exponential exponential
MONITOR
ECG acquisition Defibrillator pads and Defib pads Defib pads Multifunction electrodes in
ECG electrodes SpeedTray
Monitor with ECG Optional No No Yes
electrodes
ECG display Yes Yes
Type High-resolution backlit NA NA High-resolution backlit
LCD : NA LCD
Message display Yes
Type High-resolution backlit Lighted "dashboard" icons NA LCD
LCD : NA
Heart rate display In monitor mode : NA NA NA Digital, 0-200 bpm
Gain, mm/mV 11.6 (fixed) 11.6 (fixed) 11.6 (fixed) 5 gain settings
ELECTRODES Hydro gel Hydro gel Hydro gel Not specified
Conductive area 44 (ped)/100 cm² (adult) 85 cm² adult/ped (1 pad 85 cm² adult/ped 76 cm² per pad
set for adults and peds)
Shelf life 2 years 2 years 2 years 5 years
List price (pair) $34 adult, $85 ped $49 adult/ped (when $49 adult, $85 ped $35
equipped with pediatric
"key")
ANALYSIS
Auto or manual Auto, optional Auto Auto Auto, manual optional
auto/manual
Segment analyzed, sec 4.5 4.5 4.5 3
Analysis time, sec 9-13.5 9-13.5 9-13.5 1-12
V tach rate threshold, Adapt rate threshold Adapt rate threshold Adapt rate threshold 180; 120, 150, 180 are
bpm (multiparameter) (multiparameter) (multiparameter) configurable
VF amplitude 0.08 peak to peak 0.08 peak to peak 0.08 peak to peak >150 µV
threshold, mV
SELF TEST
Frequency Daily, weekly, monthly, at Daily, weekly, monthly, at Daily, weekly, monthly, at Daily
turn-on turn-on turn-on
Energy level, J 150 monthly 150 monthly 150 monthly 100, 150, 200, 230
CHARGE TIME
From shock advised, <10 <10 <10 6
sec
Shock-to-shock, sec <20 <20 (8.5 after CPR pause) <20 (8.5 after CPR pause) 20

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


34
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL PHILIPS MEDICAL PHILIPS MEDICAL PHILIPS MEDICAL PROGETTI
SYSTEMS SYSTEMS SYSTEMS
HeartStart FR2+ M3860A HeartStart FRx HeartStart OnSite PG DEF
: M3861A M5066A
DOCUMENTATION
Chart recorder No No No No
ECG/voice recording Removable data card Internal memory, ECG Internal memory, ECG Optional
only only
Capacity, min 8 hr ECG only 15 ECG/event data 15 ECG/event data Up to 12 hr (ECG, event)
Playback Windows-based software, No No Windows-based data
Event Review suite of management software
products
DATA STORAGE
Solid-state memory Removable data card Yes Yes Removable PC data card
(MMC)
Information stored ECG, shock and event ECG, shock and event ECG, shock and event Continuous ECG; all
summary, optional voice summary summary events/audio recording
with time optional
Capacity, min 8 hr ECG or 1 hr with 15 15 Up to 2 hr (ECG, event)
voice
Playback Data card and on unit On unit On unit Windows-based data
management software
Event record database Yes Yes Yes Yes
storage
Data management Event Review suite of Event Review suite of Event Review suite of Access DMS (Windows)
software products on PC products on PC or palm products on PC or palm
BATTERY TYPE LiMnO2 (1) LiMnO2 (1) LiMnO2 (1) LiMNO2
Integral/removable Removable Removable Removable Removable
Charging method Nonrechargeable, Nonrechargeable, Nonrechargeable, External charger optional
disposable; lithium ion disposable disposable
rechargeable
Charge time, hr 3 (lithium ion) NA NA 2
Operating time 12 hr ECG monitoring/300 4 hr/200 discharges, 5 yr 4 hr/200 discharges, 5 yr 120 full-energy shocks or
discharges/5 yr shelf life shelf life plus typical 4 yr shelf life plus typical 4 yr 12 hr continuous
plus typical 5 yr standby standby mode standby mode monitoring and 10 full
mode shocks
AC POWER No No No Optional
H x W x D, cm (in) 6.6 x 21.8 x 21.8 (2.6 x 6 x 22 x 18 (2.4 x 8.7 x 7.1 x 21 x 18.8 (2.8 x 8.3 x 7.6 x 18.5 x 10.9 (3 x 7.3 x
8.6 x 8.6) 7.1) 7.4) 4.3)
WEIGHT, kg (lb) 2.1 (4.7) w/battery 1.6 (3.5) w/battery 1.5 (3.3) w/battery 1.3 (2.9)
PURCHASE
INFORMATION
List price
Unit $2,995 : $2,395 $1,895 $1,495 $1,795
Charger $150 NA NA Not specified (optional)
Replacement batt $225 $135 $135 $35
Load simulator Not required Not required Not required $425
Memory modules $89 NA NA NA
Warranty 5 yr, optional 2 yr 5 yr, optional 2 yr 5 yr, optional 2 yr 5 years
extension; 4 yr from install extension; 4 yr from install extension; 4 yr from install
date for battery; to date for battery; to date for battery; to
expiration date for pads expiration date for pads expiration date for pads
Delivery time, ARO <30 days; replacement <30 days; replacement <30 days; replacement 30 days
within 24 hr within 24 hr within 24 hr
Year first sold 2000 2005 2002 2002
OTHER Automatically conducts Automatically conducts Automatically conducts None specified.
SPECIFICATIONS daily, weekly, and monthly daily, weekly, and monthly daily, weekly, and monthly
self-tests; tests include self-tests; tests include self-tests; tests include
verification of calibration pads presence and pads presence and
and full-energy discharge readiness, verification of readiness, verification of
test; active status calibration and full-energy calibration and full-energy
indicator. discharge test; active discharge test; active
status indicator; over 85 status indicator; over 84
different tests. different tests.
Supplier Footnotes
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


35
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL SCHILLER SCHILLER SCHILLER WELCH ALLYN
FRED FRED easy FRED easyport AED 10
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Submitted Submitted Submitted Yes
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD Not specified Not specified Not specified Not specified
DEFIBRILLATOR
Type Semiautomatic Semiautomatic Semiautomatic Semiautomatic
Manual override Optional Optional (2005) No No
Voice prompting Yes Yes Yes Yes
Number of prompts 8 8 (+7 for PAD +3 for 8 (+3 for technical 18
technical defaults) defaults)
Energy sequence, AED 130, 130, 180 or 90, 130, 90, 130, 150 adult; 15, 30, 120, 120, 120 adult; 50, 150 or 200 (shock 1); 150,
mode, J 180 50 pediatric (pediatric 50, 50 pediatric (pediatric 200, or 300 (shock 2);
settings are automatic settings are automatic 150, 200, 300, or 360
when pediatric electrodes when pediatric electrodes (shock 3 and higher)
are plugged in) are plugged in)
Energy settings, 1, 2, 4, 6, 8, 15, 30, 50, Not specified Not specified NA
manual mode, J 70, 90, 110, 130, 150, 180
Protocol configured At factory User config w/Easy Soft & User config w/Easy Soft & By user
serial cable serial cable
Output waveshape Multipulse biowave, Multipulse biowave, Multipulse biowave, Biphasic truncated
damped sinusoidal, damped sinusoidal, damped sinusoidal, exponential
biphasic multipulse biphasic multipulse biphasic multipulse
biowave, 4 + 4 msec biowave, 4 + 4 msec biowave, 4 + 4 msec
MONITOR
ECG acquisition Defib electrodes, ECG Defib electrodes Defib electrodes Pads
electrodes
Monitor with ECG Optional No No No
electrodes
ECG display Yes Yes Yes
Type Backlit LCD 130 x 70 mm Backlit LCD 100 x 37 mm Backlit LCD 60 x 40 mm NA
Message display
Type Onscreen Onscreen Onscreen LCD
Heart rate display Yes Yes No No
Gain, mm/mV Not specified Not specified Not specified NA
ELECTRODES Solid gel Solid gel Solid gel Self-seal hydro gel
Conductive area 28 or 88 cm² 28 or 78 cm² 28 or 50 cm² 101 or 106 cm²
Shelf life 2 years 2 years 2 years 1.5 years
List price (pair) $24 $24 $24 $30
ANALYSIS
Auto or manual Manual Auto, manual Auto, manual Auto
Segment analyzed, sec 4 4 4 4
Analysis time, sec <20 <10 <10 4-16
V tach rate threshold, >180 >180 >180 >160
bpm
VF amplitude >0.20 >0.20 >0.20 0.1
threshold, mV
SELF TEST
Frequency Daily with Ni-Cd batteries, Weekly At switch on Not specified
weekly with lithium
batteries
Energy level, J Not specified Not specified Not specified Not specified
CHARGE TIME
From shock advised, 6 <10 <10 Not specified
sec
Shock-to-shock, sec <20 <20 <25 Not specified

This is the first of two


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model(s). These
specifications continue
onto the next page.

©ECRI. All Rights Reserved.


36
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL SCHILLER SCHILLER SCHILLER WELCH ALLYN
FRED FRED easy FRED easyport AED 10
DOCUMENTATION
Chart recorder No No No No
ECG/voice recording PC flash card SD card Mini SD card Continuous ECG, all
events
Capacity, min 2 MB (5 hr ECG, 500 16 MB (30 ECG, 30 voice, 16 MB (30 ECG, 500 150-240
events), 10 MB (30 ECG, 500 events) events)
30 voice, 500 events)
Playback PC with software PC with software PC with software PC with Windows
DATA STORAGE
Solid-state memory Removable PCMCIA card Removable SD card Removable mini SD card Internal
Information stored ECG, events or ECG, ECG, voice, events ECG, events Continuous ECG, all
voice, events events, treatment
summary
Capacity, min 2 MB (5 hr ECG, 500 16 MB (30 ECG, 30 voice, 16 MB (30 ECG, 30 voice, NA
events), 10 MB (30 ECG, 500 events) 500 events)
30 voice, 500 events)
Playback On PC On PC On PC Any PC with Windows,
250 ECG events or 3,000
non-ECG events
Event record database Yes Yes Yes Yes
storage
Data management READER READER READER SMARTLINK
software
BATTERY TYPE Ni-Cd, lithium Li-MnO2 Li-MnO2 LiMnO2
Integral/removable Removable Removable Removable Removable
Charging method Line cord or separate NA NA NA
charger
Charge time, hr 27 (100%) NA NA NA
Operating time 450 discharges or 5 hr 240 discharges at 150 J or 60 discharges at 120 J or 90/125/150 discharges at
monitoring (lithium), 110 7 hr monitoring 4 hr monitoring 360/200/ 150 J or 5 hr of
discharges or 2.5 hr ECG monitoring
monitoring (Ni-Cd)
AC POWER Optional charging bracket Not specified None No
H x W x D, cm (in) 9 x 25 x 26 (3.5 x 9.8 x 7 x 23 x 22 (2.7 x 9 x 8.7) 3.5 x 13 x 12 (1.4 x 5.1 x 21.1 x 17.5 x 7.1 (8.3 x
10.2) 4.7) 6.9 x 2.8)
WEIGHT, kg (lb) 3.5 (7.7) 1.5 (3.4) 0.49 (1.1) 1.6 (3.5) w/battery
PURCHASE
INFORMATION
List price
Unit Not specified Not specified Not specified $2,110
Charger Not specified Not specified Not specified NA
Replacement batt Not specified Not specified Not specified $100
Load simulator Not specified Not specified Not specified $550
Memory modules Not specified Not specified Not specified NA
Warranty 3 years 5 years 1 year 5 years
Delivery time, ARO 2 weeks 2 weeks Not specified 5 days
Year first sold 1999 2002 2004 2002
OTHER Automatic self-test; SpO2; None specified. None specified. None specified.
SPECIFICATIONS options include 12-lead
diagnostic ECG, GSM
transmission, data
transmission, and ECG
analysis through ECG
cable.
Supplier Footnotes
Model Footnotes
Data Footnotes

©ECRI. All Rights Reserved.


37
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL WELCH ALLYN ZOLL ZOLL ZOLL
AED 20 AED Plus AED Pro Pro/Primary AED
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
STANDARD AED or PAD Not specified Not specified Not specified Not specified
DEFIBRILLATOR
Type Semiautomatic Automatic external w/CPR Semiautomatic w/CPR Automated w/display,
feedback feedback battery and AC power
Manual override Yes No Yes Yes
Voice prompting Yes Yes Yes Yes
Number of prompts 27 27 27 5
Energy sequence, AED 150 or 200 (shock 1); 150, 120, 150, 200 120, 150, 200 User configured
mode, J 200, or 300 (shock 2);
150, 200, 300, or 360
(shock 3 and higher)
Energy settings, 2, 5, 7, 10, 20, 30, 50, 70, NA 120, 150, 200 1-10, 15, 20, 30, 50, 75,
manual mode, J 100, 150, 200, 300, 360 100, 120, 150, 200
Protocol configured By user NA Configurable Configurable
Output waveshape Biphasic truncated Rectilinear biphasic Rectilinear biphasic Rectilinear biphasic
exponential
MONITOR
ECG acquisition Pads, ECG electrodes CPR-D Padz CPR-D Padz Electrodes, ECG
electrodes
Monitor with ECG Yes No Yes Yes
electrodes
ECG display
Type LCD LCD LCD Integral high-contrast EL
Message display
Type On ECG display LCD LCD High-contrast EL
Heart rate display Yes No Yes Yes
Gain, mm/mV 10 (autogain) NA Not specified 5, 10, 15, 20, 30
(autogain)
ELECTRODES Self-seal hydro gel Polymer gel Not specified Polymer gel
Conductive area 101 or 106 cm² 78.5 cm² front, 113 cm² 78.5 cm² front, 113 cm² 78.5 cm² front, 113 cm²
back back back
Shelf life 1.5 years 4 years 4 years 1 year
List price (pair) $30 $149 $149 $30-36
ANALYSIS
Auto or manual Auto with manual Auto Both Auto
Segment analyzed, sec override 3, 9 3 3, 9
Analysis time, sec 12-16 6-9 maximum 6-9 maximum 9 maximum
V tach rate threshold, >160 >150 >150 >150
bpm
VF amplitude 0.1 >0.1 >0.1 >0.1
threshold, mV
SELF TEST
Frequency Not specified Not specified Not specified Not specified
Energy level, J Not specified Not specified Not specified Not specified
CHARGE TIME
From shock advised, Not specified Not specified Not specified Not specified
sec
Shock-to-shock, sec Not specified Not specified Not specified Not specified

This is the first of two


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model(s). These
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38
Defibrillators, External, Automated; Semiautomated

Product Comparison Chart


MODEL WELCH ALLYN ZOLL ZOLL ZOLL
AED 20 AED Plus AED Pro Pro/Primary AED
DOCUMENTATION
Chart recorder No No No Yes
ECG/voice recording Continuous ECG, all Optional Yes Standard/optional
events, voice
Capacity, min 150-240 20 420 120 w/4 MB PC card
Playback Directly on PIC display, PC ZOLL Data Review ZOLL Data Review ZOLL Data Review
w/Windows
DATA STORAGE
Solid-state memory Removable PC data card, No Removable USB key Removable PC card
internal memory
Information stored Continuous ECG, all ECG, optional voice Complete ECG, optional ECG, event, voice, code
events, audio and voice markers, pacing
treatment summary
Capacity, min 90 continuous ECG (4 MB) 20 unlimited Data-card capacity
Playback Any PC with Windows, 100 ZOLL Data Review ZOLL Data Review ZOLL Data Review
ECG events or 300 non-
ECG events
Event record database Yes Yes Yes Yes
storage
Data management SMARTVIEW/SMARTLINK ZOLL Data Review ZOLL Data Review ZOLL RescueNet
software
BATTERY TYPE Ni-MH/LiMnO2 123A LiMgO2 SLA/lithium ion Rechargeable SLA
(rechargeable and
disposable)
Integral/removable Removable Removable Removable Removable
Charging method Separate Smart Charger NA External AC or battery support
Charge time, hr 1.5-2 NA 4 4 w/integral charger
Operating time See other specications 300 shocks or 1.5 hr 6-13 hr 35 discharges @ max
continuous energy or 3 hr continuous
monitoring/defibrillation monitoring, 2.5 hr
continuous
monitoring/pacing
AC POWER No None None Standard
H x W x D, cm (in) 23.9 x 22.9 x 7.6 (9.4 x 9 x 13.5 x 24.1 x 29.2 (5.3 x 9.9 x 5.1 x 23.9 (3.9 x 2 x 17 x 25.9 x 20.5 (6.7 x
3) 9.5 x 11.5) 9.4) 10.2 x 8.1)
WEIGHT, kg (lb) <2 (4.5) 2.9 (6.5) 2.4 (5.2) without battery 5.2 (11.5)
PURCHASE
INFORMATION
List price
Unit $3,460-4,225, varies by $1,895-2,095 $3,795 $5,490-9,790
configuration
Charger Included NA $1,545 $1,545
Replacement batt $200 $75 $130 $130
Load simulator $550 $149 $149 Integral
Memory modules $200 4 MB card NA NA $350 (pack of 2 PCMCIA
cards)
Warranty 5 years 5 years 5 years 5 years (hospital use)
Delivery time, ARO 5 days Not specified 30-60 days Not specified
Year first sold 2000 2002 2005 1999
OTHER 80/120/150 discharges at 1-piece electrode design 1-piece electrode design ZOLL uniform operating
SPECIFICATIONS 360/200/150 J or 3 hr of that incoporates CPR that incoporates CPR system; hands-free
ECG monitoring (Ni-MH); feedback on depth and feedback on depth and operation; 2/1 PC-card
200/285/350 discharges at rate of compression for rate of compression for slots; error-correction
360/200/150 J or 6 hr ECG nonshockable events. nonshockable events; prompts; universal cable;
monitoring (lithium). standard defibrillator pads. 3-lead patient cable (Pro).
Supplier Footnotes
Model Footnotes
Data Footnotes

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