defibrillators type comparison: external, automated, semi automated

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™):

Defibrillators, External, Automated [17-116] 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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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,



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



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,



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



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


http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01314.html


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.



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-



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.

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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.



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].


http://65.213.73.178/detail/org.aspx?oid=1377





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.




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,



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


http://www.accesscardiosystems.com/

http://www.accesscardiosystems.com/recall.pdf


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.


http://www.medtronic-ers.com/500/

http://www.fda.gov/oc/po/firmrecalls/lifepak02_05.html


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


http://www.fda.gov/oc/po/firmrecalls/heartsine03_05.html

http://www.mhra.gov.uk/

http://www.medtronic-ers.com/500


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.comE-mail: [email protected]


http://www.fda.gov/cdrh/recalls/recall-042805.html

http://www.fda.gov/oc/po/firmrecalls/mrl05_05.html

http://www.burdick.com/

mailto:[email protected]


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.comE-mail: [email protected]

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.comEmail: [email protected]

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.comE-mail: [email protected] HeartSine Technologies Ltd [412551] Canberra House 203 Airport Road West Northern Ireland Phone: 44 (2890) 939400 Fax: 44 (2890) 939401 Internet: http://www.heartsine.comE-mail: [email protected]

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


http://www.cardiacscience.com/


http://www.defibtech.com/


http://www.heartsine.com/


http://www.heartsine.com/


http://www.medtronic-ers.com/





Metrax Metrax GmbH [172393] Reinwaldstrasse 22 D-78682 Rottweil Germany Phone: 49 (741) 2570 Fax: 49 (741) 257235 Internet: http://www.primedic.deE-mail: [email protected]

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.comE-mail: [email protected]

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.comE-mail: [email protected]

Schiller Schiller AG [162079] Altgasse 68 CH-6341 Baar Switzerland Phone: 41 (41) 7664242 Fax: 41 (41) 7610880 Internet: http://www.schiller.chE-mail: [email protected] 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.comE-mail: [email protected] Schiller Medical SAS [401027] 4 rue Louis Pasteur F-67162 Wissembourg


http://www.primedic.de/


http://www.medical.philips.com/




http://www.progettimedical.com/


http://www.schiller.ch/


http://www.schiller.com/



France Phone: 33 (3) 88633600 Fax: 33 (3) 88941282 Internet: http://www.schiller-medical.comE-mail: [email protected]

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.comE-mail: [email protected] 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.comE-mail: [email protected] 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.comE-mail: [email protected]

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.comE-mail: [email protected] 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.comE-mail: [email protected] 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.comE-mail: [email protected] 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.comE-mail: [email protected]


http://www.schiller-medical.com/


http://www.welchallyn.com/






http://www.zoll.com/









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 AED — Automated external defibrillator ALS — Advanced life support bpm — Beats per minute CE mark — Conformite Europeene mark CPR — Cardiopulmonary resuscitation CRT — Cathode ray tube CSA — Canadian Standards Association ECG — Electrocardiogram FDA — U.S. Food and Drug Administration IBP — Invasive blood pressureIEC — International Electrotechnical Commission

LCD — Liquid crystal display LED — Light-emitting diode MDD — Medical Devices Directive Ni-Cd — Nickel-cadmium Ni-MH — Nickel metal hydride PC — Personal computer PCMCIA — Personal Computer Memory Card International Association RAM — Random-access memory SLA — Sealed lead-acid UL — Underwriters Laboratories VF — Ventricular fibrillation 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 [email protected] (e-mail).




Product Comparison Chart




MODEL ECRI-RECOMMENDED

SPECIFICATIONS1ECRI-RECOMMENDED SPECIFICATIONS1

BURDICK BURDICK

Standard AED Public-Access Defibrillator (PAD)

CardioVive AT CardioVive DM

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 mode, J

Any Any Variable Variable

Energy settings, manual mode, J

Any Any 50-360 50-360

Protocol configured Yes Yes Output waveshape Biphasic preferred Biphasic preferred Biphasic truncated

exponential Biphasic truncated exponential

MONITOR ECG acquisition Electrodes Electrodes Monitor with ECG electrodes

Not specified Yes

ECG display Type Optional; no preference No LCD (through PC

interface) LCD (through PC 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, bpm

Any Any User selectable User selectable

VF amplitude threshold, mV

Any Any 0.08 0.08

SELF TEST Frequency Not specified Not specified Energy level, J Not specified Not specified

CHARGE TIME From shock advised, sec

Not specified Not specified

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.




MODEL ECRI-RECOMMENDED

SPECIFICATIONS1ECRI-RECOMMENDED SPECIFICATIONS1

BURDICK BURDICK

Standard AED Public-Access Defibrillator (PAD)

CardioVive AT CardioVive DM

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

shock, time, date, rhythm, others

ECG, recommended shock, time, date, rhythm, others

Capacity, min >15 >15 Not specified Not specified Playback Any Any RescueLink software, full-

disclosure playback RescueLink software, full-disclosure playback

Event record database storage

Yes Yes Yes Yes

Data management software

No preference No preference RescueLink RescueLink

BATTERY TYPE No preference No preference Lithium (extended life) Lithium (extended life) Integral/removable Removable Removable Removable Removable Charging method Nonrechargeable

preferred Nonrechargeable preferred


Charge time, hr NA NA Operating time >30 discharges or 2 hr

continuous ECG monitoring

>30 discharges or 2 hr continuous ECG monitoring

260 shocks at 360 J 260 shocks at 360 J

AC POWER Optional Optional NA NA H x W x D, cm (in) 8.4 x 26.9 x 31.5 (3.3 x

10.6 x 12.4) 8.4 x 26.9 x 31.5 (3.3 x 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 SPECIFICATIONS

RescueReady reliability; daily self-tests confirm that battery, internal circuitry, and preconnected electrodes are fully functional.

RescueReady reliability; daily self-tests confirm that battery, internal circuitry, and preconnected electrodes are fully functional.

Supplier Footnotes 1These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on this data.

1These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on this data.

Model Footnotes Data Footnotes




MODEL CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE Powerheart AED G3 Powerheart AED G3

Automatic Powerheart AED G3 Pro Powerheart Cardiac

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

manual override Automatic continuous monitoring or semiautomatic

Manual override No No No Yes Voice prompting Yes Yes Yes Yes Number of prompts 20 23 27 7


200, 300, 300 200, 300, 300 200, 300, 300 Auto and advisory per physician protocol (5-270 J), AED fixed at 200, 200, 270


NA NA 200, 300, 300 5-270

Protocol configured Yes Yes Yes Yes Output waveshape Biphasic truncated


Biphasic truncated exponential


MONITOR ECG acquisition Defib electrodes Defib electrodes Defib or monitoring

electrodes Defib electrode pads or ECG monitoring electrodes

Monitor with ECG electrodes

No No Yes Yes

ECG display Type NA NA Full color, transflective,

320 x 240 pixels STN color, 240 x 320 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, bpm

120-240, user selectable 120-240, user selectable 120-240, user selectable 120-240, user selectable


0.08 0.08 0.08 0.2

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

(monthly) Partial (weekly), full (monthly)

Partial (weekly), full (monthly)

Not specified


9 (for analysis) 9 (for analysis) 9 (for analysis) Continuous

Shock-to-shock, sec 3 shocks in 55 sec 3 shocks in 55 sec 3 shocks in 55 sec 10





MODEL CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE CARDIAC SCIENCE Powerheart AED G3 Powerheart AED G3

Automatic Powerheart AED G3 Pro Powerheart Cardiac

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

PC RescueLink software to PC

RescueLink software to PC

Data downloaded and reviewed on PC


Yes Yes Yes Yes


RescueLink RescueLink RescueLink Event Review Software Kit

BATTERY TYPE Lithium (extended life) Lithium (extended life) Lithium (extended life) SLA Integral/removable Removable Removable Removable Integral Charging method Disposable Disposable Disposable, optional

rechargeable Line cord

Charge time, hr NA NA 4.5 for completely depleted battery

10 maximum

Operating time Up to 290 shocks Up to 290 shocks Up to 290 shocks or 12 hr of use, rechargeable lasts for 100 shocks or 6 hr of monitoring

3 hr monitoring/2 hr pacing with new and fully charged battery, 30 Emax 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

10.6 x 12.4) 8.4 x 26.9 x 31.5 (3.3 x 10.6 x 12.4)

8.4 x 26.9 x 31.5 (3.3 x 10.6 x 12.4)

25.4 x 11.2 x 29.2 (10 x 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 electrodes/battery

7 years, excluding electrodes/battery

7 years, excluding electrodes/battery

1.5 years

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


Semiautomatic AED; RescueReady indicator; nonpolarized electrodes; electrode self-test for presence and functionality; battery capacity gauge; 4-year full replacement battery; 1-button operation.

Fully automatic AED eliminates decision making for ease of use; RescueReady indicator; nonpolarized electrodes; electrode self-test for presence and functionality; battery capacity gauge; 4-year full replacement battery.

Semiautomatic with manual override functionality; color ECG display; RescueReady indicator; ECG monitoring allows professional user to take control of rescue.

Automatically detects VT, VF, and SVT and delivers cardioversion, pacing, or defibrillation or pacing; designed for in-hospital use.

Supplier Footnotes Model Footnotes Data Footnotes




MODEL DEFIBTECH HEARTSINE HEARTSINE MEDTRONIC LIFELINE AED Samaritan AED (001 : 002

: 003) Samaritan PAD LIFEPAK 500 AED

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


150 100, 150, 200, or as set in protocol

100, 150, 200 200-360 configurable (150 by country)


Not specified 100, 150, 200, 230 : Optional : Optional

NA NA

Protocol configured Yes Yes Yes Yes Output waveshape Biphasic truncated



Biphasic truncated exponential with voltage and duration compensation for patient impedance

MONITOR ECG acquisition Pads Defibrillation or

monitoring-only electrodes : Defibrillation electrodes : Defibrillation electrodes

None Disposable multifunction electrodes


No Yes : Optional : Optional NA No

ECG display Type No High-resolution backlit

LCD NA NA

Message display No Type No High-resolution backlit

LCD NA LCD

Heart rate display No Yes NA No Gain, mm/mV No Autogain NA NA

ELECTRODES Single-use, non-polarized, self-adhesive

Solid gel Pads Solid gel

Conductive area 50 cm² for DDP-200P (pediatric/infant), 103 cm² for DDP-100 (adult)

100 cm² 100 cm² 82 cm²

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, bpm

Not specified 180 (multiparameter) 181 (multiparameter) >120


Not specified 150 µV 150 µV >0.08

SELF TEST Frequency Daily, weekly, monthly Not specified Not specified Not specified Energy level, J 150 Not specified Not specified Not specified


<6 Not specified Not specified Not specified

Shock-to-shock, sec <20 Not specified Not specified Not specified





MODEL DEFIBTECH HEARTSINE HEARTSINE MEDTRONIC LIFELINE AED Samaritan AED (001 : 002

: 003) Samaritan PAD LIFEPAK 500 AED

ADAPTIV Biphasic DOCUMENTATION Chart recorder Optional No No No ECG/voice recording Yes/no Automatic to removable

battery Continuous ECG Yes/optional

Capacity, min 12 hours of ECG and events on removable data card

60 voice, 12 hr ECG 45 ECG and event data 20-80

Playback Downloaded SAVER Windows PC software

SAVER Windows PC software

Direct connection to PC, modem connection to PC, direct print

DATA STORAGE Solid-state memory Removable data card Integrated in Data Pak

battery Integrated in PAD unit Internal

Information stored ECG, events Continuous ECG, voice, event data, device status

ECG, events time stamped

ECG, events, voice, test log

Capacity, min Up to 12 hours 720 45 20-80 Playback Downloaded On PC On PC Data management

software Event record database storage

Yes Yes Yes Yes


Not specified Yes Yes DT Express/Code-Stat 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 (disposable)

Nonrechargeable (disposable)

Battery charger (SLA only)

Charge time, hr NA 2 NA 10 to full capacity Operating time 125 shocks or 8 hours

continuous operation (Model DBP-1400); 300 shocks or 16 hours continuous operation (Model DBP-2800)

12 hr ECG monitoring minimum, 120 x 200 J shocks (new battery)

6 hr or >30 shocks 18 hr monitoring/418 discharges, LiMnO2; 14 hr monitoring/312 discharges, LiSO2; 3 hr monitoring/59 discharges, 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

2.7) 20.5 x 25.8 x 6 (8.1 x 10.2 x 2.4)

20.3 x 17.8 x 5.1 (8 x 7 x 2)

10.2 x 26.7 x 29.5 (4 x 10.5 x 11.6)

WEIGHT, kg (lb) 1.9 (4.2) with DBP-1400, 2 (4.4) with DBP-2800

1.8 (4) 0.9 (2) 2.4 (5.3)

PURCHASE INFORMATION

List price Unit Not specified $2,995 : $2,795 : $2,695 $1,595, includes carry

case, 2 Pad-Paks (defib pads and batteries)

$3,605

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


Pads preconnected tested daily; unit and battery pack system test by user; visual and audible indication of unit status; splash proof.

1-2-3 operation; large 12.5 cm (5 in) diagonal display; readiness indicator with self-tests; rugged rubberized case; IPX4 splashproof; Intelligent Battery System; carrying case and mounting support system optional.

1-2-3 operation; large illuminating graphical interface; readiness indicator with self-tests; rugged rubberized case; IPX4 splashproof; combined electrode and battery pak.

Readiness status display; multiple configurable setup options; splashproof IPX4 rated; preconnected electrodes compatible with other LIFEPAK defibrillators.

Supplier Footnotes 1These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on this data.

Model Footnotes Data Footnotes




MODEL MEDTRONIC MEDTRONIC METRAX METRAX LIFEPAK 500 AED

Monophasic LIFEPAK CR Plus ADAPTIV Biphasic

HeartSave 6 HeartSave 6S

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

manual mode and cardioversion

Advanced AED with manual mode and cardioversion and SpO2

DEFIBRILLATOR Type Semiautomatic Semiautomatic or fully

automatic Semiautomatic and manual

Semiautomatic and manual

Manual override No No Yes Yes Voice prompting Yes Yes Yes Yes Number of prompts Numerous Numerous 38 38


200-360 configurable (150 by country)

200-360 configurable (150 by country)

Not specified (low, medium, high)



NA NA 50, 100, 200, 300, 360 50, 100, 200, 300, 360

Protocol configured Yes Yes Low, medium, high Low, medium, high Output waveshape Monophasic damped sine

(Edmark) Biphasic truncated exponential

Biphasic Biphasic

MONITOR ECG acquisition Disposable multifunction

electrodes Disposable, QUIK-PAK multifunction

Multifunction electrodes in front cover



No No Yes Yes

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

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, bpm

>120 >120 Not specified Not specified


>0.08 >0.08 >200 µV >200 µV

SELF TEST Frequency Not specified Not specified Daily, monthly, every 6

months Daily, monthly, every 6 months

Energy level, J Not specified Not specified Up to max energy every 6 months

Up to max energy every 6 months


Not specified Not specified 12 12

Shock-to-shock, sec Not specified Not specified Not specified Not specified





MODEL MEDTRONIC MEDTRONIC METRAX METRAX LIFEPAK 500 AED

Monophasic LIFEPAK CR Plus ADAPTIV Biphasic

HeartSave 6 HeartSave 6S

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,

modem connection to PC, direct print

Via wireless IrDA port Windows-based data management software

Windows-based data management software

DATA STORAGE Solid-state memory Internal Internal digital Removable compact

Flash card Removable compact Flash card

Information stored ECG, events, voice, test log

ECG, events, markers, test log

Continuous ECG, all events/audio recording


Capacity, min 20-80 20 ECG Up to 12 hr (ECG, event) Up to 12 hr (ECG, event) Playback Data management

software Data management software




Yes 200 time-stamped event-log markers

Yes Yes


DT Express/Code-Stat Suite

DT Express/Code-Stat Suite

Windows Windows

BATTERY TYPE LiMnO2, LiSO2, SLA Internal hybrid layer capacitor (HLC)

LiMnO2 LiMnO2

Integral/removable Separate Removable CHARGE-PAK battery charger

Removable Removable

Charging method Battery charger (SLA only) CHARGE-PAK battery charger

NA (disposable) NA (disposable)

Charge time, hr 10 to full capacity NA NA NA Operating time 18 hr monitoring/418

discharges, LiMnO2; 14 hr monitoring/312 discharges, LiSO2; 3 hr monitoring/59 discharges, SLA

30 full discharges or 210 min of on time w/fully charged device

110 full-energy shocks or 15 hr continuous monitoring


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

10.5 x 11.6) 10.7 x 20.3 x 24.1 (4.2 x 8 x 9.5)

26 x 26 x 9 (10.2 x 10.2 x 3.5)

26 x 26 x 9 (10.2 x 10.2 x 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

includes CHARGE-PAK battery charger and 1 set of QUIK-PAK electrodes

NA NA

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


Multiple configurable setup options; splashproof IPX4 rated; preconnected electrodes compatible with other LIFEPAK defibrillators.

Readiness status display; multiple configurable setup options; splashproof IPX4 rated; preconnected electrodes; compatible with other LIFEPAK defibrillators.

None specified. None specified.





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

telemetry system PAD with patented 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







NA NA NA NA

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

front cover Multifunction electrodes in front cover




No Yes Yes Yes

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, bpm

Not specified Not specified Not specified Not specified


>200 µV >200 µV >200 µV >200 µV

SELF TEST Frequency Daily, monthly, every 6

months Daily, monthly, every 6 months

Daily, monthly, every 6 months

Daily, monthly, every 6 months

Energy level, J Up to max energy every 6 months





12 12 12 12






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

management software Windows-based data management software



DATA STORAGE Solid-state memory Removable compact

Flash card Removable compact Flash card

Removable compact Flash card

Removable compact Flash card

Information stored Continuous ECG, all 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

management software Windows-based data management software




Yes Yes Yes Yes


Windows Windows Windows Windows

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 15 hr continuous 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

3.5) 26 x 26 x 9 (10.2 x 10.2 x 3.5)

26 x 26 x 9 (10.2 x 10.2 x 3.5)

26 x 26 x 9 (10.2 x 10.2 x 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


None specified. None specified. None specified. None specified.





MODEL PHILIPS MEDICAL

SYSTEMS PHILIPS MEDICAL SYSTEMS

PHILIPS MEDICAL SYSTEMS

PROGETTI

HeartStart FR2+ M3860A : M3861A

HeartStart FRx HeartStart OnSite M5066A

PG DEF

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE Yes Yes Yes, including sale w/o

prescription Yes

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

coaching 71 including CPR coaching

Not specified


150 fixed 150 fixed 150 fixed Escalating, 110-200


150 NA NA Escalating, 110-230

Protocol configured With training/admin pack With Event Review software & HeartStart Configure Palm handheld software

With Event Review software & HeartStart Configure Palm handheld software

100, 150, 200, 230

Output waveshape Biphasic truncated exponential




MONITOR ECG acquisition Defibrillator pads and

ECG electrodes Defib pads Defib pads Multifunction electrodes in

SpeedTray Monitor with ECG electrodes

Optional No No Yes

ECG display Yes Yes Type High-resolution backlit

LCD : NA NA NA High-resolution backlit

LCD Message display Yes Type High-resolution backlit

LCD : NA Lighted "dashboard" icons NA LCD

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

set for adults and peds) 85 cm² adult/ped 76 cm² per pad

Shelf life 2 years 2 years 2 years 5 years List price (pair) $34 adult, $85 ped $49 adult/ped (when

equipped with pediatric "key")

$49 adult, $85 ped $35

ANALYSIS Auto or manual Auto, optional

auto/manual Auto Auto Auto, manual optional

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, bpm

Adapt rate threshold (multiparameter)



180; 120, 150, 180 are configurable


0.08 peak to peak 0.08 peak to peak 0.08 peak to peak >150 µV

SELF TEST Frequency Daily, weekly, monthly, at

turn-on Daily, weekly, monthly, at turn-on

Daily, weekly, monthly, at turn-on

Daily

Energy level, J 150 monthly 150 monthly 150 monthly 100, 150, 200, 230 CHARGE TIME From shock advised, sec

<10 <10 <10 6

Shock-to-shock, sec <20 <20 (8.5 after CPR pause) <20 (8.5 after CPR pause) 20





MODEL PHILIPS MEDICAL

SYSTEMS PHILIPS MEDICAL SYSTEMS

PHILIPS MEDICAL SYSTEMS

PROGETTI

HeartStart FR2+ M3860A : M3861A

HeartStart FRx HeartStart OnSite M5066A

PG DEF

DOCUMENTATION Chart recorder No No No No ECG/voice recording Removable data card Internal memory, ECG

only Internal memory, ECG only

Optional

Capacity, min 8 hr ECG only 15 ECG/event data 15 ECG/event data Up to 12 hr (ECG, event) Playback Windows-based software,

Event Review suite of products

No No Windows-based data management software

DATA STORAGE Solid-state memory Removable data card Yes Yes Removable PC data card

(MMC) Information stored ECG, shock and event

summary, optional voice ECG, shock and event summary

ECG, shock and event summary

Continuous ECG; all events/audio recording with time optional

Capacity, min 8 hr ECG or 1 hr with voice

15 15 Up to 2 hr (ECG, event)

Playback Data card and on unit On unit On unit Windows-based data management software


Yes Yes Yes Yes


Event Review suite of products on PC

Event Review suite of products on PC or palm

Event Review suite of products on PC or palm

Access DMS (Windows)

BATTERY TYPE LiMnO2 (1) LiMnO2 (1) LiMnO2 (1) LiMNO2 Integral/removable Removable Removable Removable Removable Charging method Nonrechargeable,

disposable; lithium ion rechargeable

Nonrechargeable, disposable

Nonrechargeable, disposable

External charger optional

Charge time, hr 3 (lithium ion) NA NA 2 Operating time 12 hr ECG monitoring/300

discharges/5 yr shelf life plus typical 5 yr standby mode

4 hr/200 discharges, 5 yr shelf life plus typical 4 yr standby mode

4 hr/200 discharges, 5 yr shelf life plus typical 4 yr standby mode

120 full-energy shocks or 12 hr continuous monitoring and 10 full 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

8.6 x 8.6) 6 x 22 x 18 (2.4 x 8.7 x 7.1)

7.1 x 21 x 18.8 (2.8 x 8.3 x 7.4)

7.6 x 18.5 x 10.9 (3 x 7.3 x 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 extension; 4 yr from install date for battery; to expiration date for pads

5 yr, optional 2 yr extension; 4 yr from install date for battery; to expiration date for pads

5 yr, optional 2 yr extension; 4 yr from install date for battery; to expiration date for pads

5 years

Delivery time, ARO <30 days; replacement within 24 hr

<30 days; replacement within 24 hr

<30 days; replacement within 24 hr

30 days

Year first sold 2000 2005 2002 2002 OTHER SPECIFICATIONS

Automatically conducts daily, weekly, and monthly self-tests; tests include verification of calibration and full-energy discharge test; active status indicator.

Automatically conducts daily, weekly, and monthly self-tests; tests include pads presence and readiness, verification of calibration and full-energy discharge test; active status indicator; over 85 different tests.

Automatically conducts daily, weekly, and monthly self-tests; tests include pads presence and readiness, verification of calibration and full-energy discharge test; active status indicator; over 84 different tests.

None specified.





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

technical defaults) 8 (+3 for technical defaults)

18


130, 130, 180 or 90, 130, 180

90, 130, 150 adult; 15, 30, 50 pediatric (pediatric settings are automatic when pediatric electrodes are plugged in)

120, 120, 120 adult; 50, 50, 50 pediatric (pediatric settings are automatic when pediatric electrodes are plugged in)

150 or 200 (shock 1); 150, 200, or 300 (shock 2); 150, 200, 300, or 360 (shock 3 and higher)


1, 2, 4, 6, 8, 15, 30, 50, 70, 90, 110, 130, 150, 180

Not specified Not specified NA

Protocol configured At factory User config w/Easy Soft & serial cable

User config w/Easy Soft & serial cable

By user

Output waveshape Multipulse biowave, damped sinusoidal, biphasic multipulse biowave, 4 + 4 msec

Multipulse biowave, damped sinusoidal, biphasic multipulse biowave, 4 + 4 msec

Multipulse biowave, damped sinusoidal, biphasic multipulse biowave, 4 + 4 msec


MONITOR ECG acquisition Defib electrodes, ECG

electrodes Defib electrodes Defib electrodes Pads


Optional No No No

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, bpm

>180 >180 >180 >160


>0.20 >0.20 >0.20 0.1

SELF TEST Frequency Daily with Ni-Cd batteries,

weekly with lithium batteries

Weekly At switch on Not specified

Energy level, J Not specified Not specified Not specified Not specified CHARGE TIME From shock advised, sec

6 <10 <10 Not specified

Shock-to-shock, sec <20 <20 <25 Not specified





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

events), 10 MB (30 ECG, 30 voice, 500 events)

16 MB (30 ECG, 30 voice, 500 events)

16 MB (30 ECG, 500 events)

150-240

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,

voice, events ECG, voice, events ECG, events Continuous ECG, all

events, treatment summary

Capacity, min 2 MB (5 hr ECG, 500 events), 10 MB (30 ECG, 30 voice, 500 events)



NA

Playback On PC On PC On PC Any PC with Windows, 250 ECG events or 3,000 non-ECG events


Yes Yes Yes Yes


READER READER READER SMARTLINK

BATTERY TYPE Ni-Cd, lithium Li-MnO2 Li-MnO2 LiMnO2 Integral/removable Removable Removable Removable Removable Charging method Line cord or separate

charger NA NA NA

Charge time, hr 27 (100%) NA NA NA Operating time 450 discharges or 5 hr

monitoring (lithium), 110 discharges or 2.5 hr monitoring (Ni-Cd)

240 discharges at 150 J or 7 hr monitoring

60 discharges at 120 J or 4 hr monitoring

90/125/150 discharges at 360/200/ 150 J or 5 hr of ECG monitoring

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

10.2) 7 x 23 x 22 (2.7 x 9 x 8.7) 3.5 x 13 x 12 (1.4 x 5.1 x

4.7) 21.1 x 17.5 x 7.1 (8.3 x 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


Automatic self-test; SpO2; options include 12-lead diagnostic ECG, GSM transmission, data transmission, and ECG analysis through ECG cable.

None specified. None specified. None specified.





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

feedback Semiautomatic w/CPR feedback

Automated w/display, battery and AC power

Manual override Yes No Yes Yes Voice prompting Yes Yes Yes Yes Number of prompts 27 27 27 5


150 or 200 (shock 1); 150, 200, or 300 (shock 2); 150, 200, 300, or 360 (shock 3 and higher)

120, 150, 200 120, 150, 200 User configured


2, 5, 7, 10, 20, 30, 50, 70, 100, 150, 200, 300, 360

NA 120, 150, 200 1-10, 15, 20, 30, 50, 75, 100, 120, 150, 200

Protocol configured By user NA Configurable Configurable Output waveshape Biphasic truncated

exponential Rectilinear biphasic Rectilinear biphasic Rectilinear biphasic

MONITOR ECG acquisition Pads, ECG electrodes CPR-D Padz CPR-D Padz Electrodes, ECG

electrodes Monitor with ECG electrodes

Yes No Yes Yes

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

back 78.5 cm² front, 113 cm² back

78.5 cm² front, 113 cm² 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, bpm

>160 >150 >150 >150


0.1 >0.1 >0.1 >0.1

SELF TEST Frequency Not specified Not specified Not specified Not specified Energy level, J Not specified Not specified Not specified Not specified


Not specified Not specified Not specified Not specified






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

events, voice Optional Yes Standard/optional

Capacity, min 150-240 20 420 120 w/4 MB PC card Playback Directly on PIC display, PC

w/Windows ZOLL Data Review ZOLL Data Review ZOLL Data Review

DATA STORAGE Solid-state memory Removable PC data card,

internal memory No Removable USB key Removable PC card

Information stored Continuous ECG, all events, audio and treatment summary

ECG, optional voice Complete ECG, optional voice

ECG, event, voice, code markers, pacing

Capacity, min 90 continuous ECG (4 MB) 20 unlimited Data-card capacity Playback Any PC with Windows, 100

ECG events or 300 non-ECG events

ZOLL Data Review ZOLL Data Review ZOLL Data Review


Yes Yes Yes Yes


SMARTVIEW/SMARTLINK ZOLL Data Review ZOLL Data Review ZOLL RescueNet

BATTERY TYPE Ni-MH/LiMnO2 123A LiMgO2 SLA/lithium ion (rechargeable and disposable)

Rechargeable SLA

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 continuous monitoring/defibrillation

6-13 hr 35 discharges @ max energy or 3 hr continuous 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

3) 13.5 x 24.1 x 29.2 (5.3 x 9.5 x 11.5)

9.9 x 5.1 x 23.9 (3.9 x 2 x 9.4)

17 x 25.9 x 20.5 (6.7 x 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

configuration $1,895-2,095 $3,795 $5,490-9,790

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


80/120/150 discharges at 360/200/150 J or 3 hr of ECG monitoring (Ni-MH); 200/285/350 discharges at 360/200/150 J or 6 hr ECG monitoring (lithium).

1-piece electrode design that incoporates CPR feedback on depth and rate of compression for nonshockable events.

1-piece electrode design that incoporates CPR feedback on depth and rate of compression for nonshockable events; standard defibrillator pads.

ZOLL uniform operating system; hands-free operation; 2/1 PC-card slots; error-correction prompts; universal cable; 3-lead patient cable (Pro).



defibrillators type comparison: external, automated, semi automated

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