10-K 1 d221219d10k.htm FORM 10-K
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`Table of Contents
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`WASHINGTON, D.C. 20549
`FORM 10-K
`
`(MARK ONE)
`(cid:95) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`FOR THE FISCAL YEAR ENDED OCTOBER 2, 2011
`
`OR
`(cid:133) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`FOR THE TRANSITION PERIOD FROM TO .
`COMMISSION FILE NUMBER 0-20225
`
`ZOLL MEDICAL CORPORATION
`
`(Exact name of registrant as specified in its charter)
`
`MASSACHUSETTS
`(State or other jurisdiction of
`incorporation or organization)
`269 MILL ROAD, CHELMSFORD,
`MASSACHUSETTS
`01824
`(Zip Code)
`(Address of principal executive offices)
`Registrant’s telephone number, including area code (978) 421-9655
`Securities registered pursuant to Section 12(b) of the Act:
`Title of each class
`Name of each exchange on which registered
`Common Stock, $0.01 Par Value
`The NASDAQ Stock Market LLC
`Stock Purchase Rights
`
`04-2711626
`(I.R.S. Employer
`Identification No.)
`
`Securities registered pursuant to Section 12(g) of the Act:
`None
`(Title of class)
`
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:95) No (cid:133)
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes (cid:133) No (cid:95)
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
`Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been
`subject to such filing requirements for the past 90 days. Yes (cid:95) No (cid:133).
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
`Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12
`months (or for such shorter period that the registrant was required to submit and post such files). Yes (cid:95) No (cid:133)
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained
`herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference
`in Part III of this Form 10-K or any amendment to this Form 10-K. (cid:133)
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
`company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
`Act (Check one):
`Large accelerated filer (cid:95) Accelerated filer (cid:133) Non-accelerated filer (cid:133) Smaller reporting company (cid:133)
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:133) No (cid:95)
`The aggregate market value of the voting stock held by non-affiliates of the registrant as of April 3, 2011 was $968,067,620 based on a
`closing sales price of $44.57 (the closing price on April 1, 2011) per share as reported on the NASDAQ Global Select Market (for this
`computation, the registrant has excluded the market value of all shares of Common Stock reported as beneficially owned by directors and
`executive officers of the registrant, but includes certain shares beneficially owned by persons known to the registrant to beneficially own more
`than 10% of the registrant’s Common Stock.)
`The number of shares of the registrant’s single class of common stock outstanding as of November 8, 2011 was 22,146,937.
`
`Philips Exhibit 2012
`Zoll Lifecor v. Philips
`IPR2013-00606
`
`Page 1 of 112
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`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive Proxy Statement for the Registrant’s 2012 Annual Meeting of Shareholders that the Registrant intends to file with
`the Securities and Exchange Commission within 120 days of the Registrant’s fiscal year ended October 2, 2011 are incorporated by reference
`into Part III of this Annual Report on Form 10-K.
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`ZOLL MEDICAL CORPORATION
`Annual Report on Form 10-K
`For the Year Ended October 2, 2011
`
`Table of Contents
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Removed and Reserved
`
`Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Selected Financial Data
`Management’s Discussion and Analysis of Financial Condition and Results of Operations
`Quantitative and Qualitative Disclosures About Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
`Part I
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`Part II
`Item 5.
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`Part III
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`Part IV
`Item 15.
`Signatures
`Index to Consolidated Financial Statements
`
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accountant Fees and Services
`
`Exhibits, Financial Statement Schedules
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`2
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`Page No.
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`3
`23
`38
`38
`38
`38
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`39
`42
`42
`57
`59
`93
`93
`93
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`95
`95
`95
`95
`95
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`97
`101
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`PART I
`
`Certain statements contained herein constitute “forward-looking statements” as that term is defined under the Private Securities Litigation
`Reform Act of 1995 (the “Act”) and releases issued by the SEC and within the meaning of Section 27A of the Securities Act of 1933 and
`Section 21E of the Securities Exchange Act of 1934. The words “anticipates,” “believes,” “expects,” “intends,” “sees,” “future,” “may,” “will,”
`“would,” “can,” “could,” “estimates,” “plans,” “target,” “goal,” “project” and other expressions which are predictions of or indicate future
`events and trends and which do not relate to historical matters identify forward-looking statements. Particularly, the Company’s expectations
`regarding its business, operational results, future operational liquidity, contractual obligations and other commercial commitments, and capital
`requirements are forward-looking statements. Reliance should not be placed on forward-looking statements because they involve known and
`unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to differ
`materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. The
`Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future
`events or otherwise. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking
`statements include, but are not limited to, the actions of competitors, the acceptance of our products in their respective markets, adverse
`economic conditions, and those other risks and uncertainties contained in this Annual Report on Form 10-K, including in Item 1A of Part I
`entitled “Risk Factors”.
`
`Item 1. Business.
`Overview
`ZOLL Medical Corporation (ZOLL, the Company, we or us) develops, manufactures, and markets resuscitation devices, related data
`management and software solutions, and temperature management technology. ZOLL is continuing its expansion from its founding focus on
`external pacemakers and defibrillators for the treatment of cardiac arrest to a much broader focus on a range of resuscitation devices and
`temperature management solutions for critical care and surgical patients. This expanded focus involves not only initial care but prevention of
`sudden cardiac death in patients with a known risk, as well as care after an event, where initial resuscitation success can be enhanced with
`specific strategies for improving recovery and reducing morbidity. As the science of resuscitation continues to expand, so does our business
`opportunity and the potential for revenue growth. We believe there is a substantially greater opportunity to improve operating profitability and
`achieve significant recurring revenues as we provide products and services to a much larger resuscitation and critical care market.
`
`Historically, ZOLL grew primarily from its core defibrillation and pacing technologies used to treat victims of sudden cardiac arrest
`(SCA) and other heart arrhythmias. This primarily involved the sale of capital equipment to the hospital and emergency medical services
`(EMS) markets. With a strong product differentiation strategy, ZOLL has been successful at driving long-term revenue growth by increasing its
`market share through significant investments in research and development and building direct sales and distribution channels.
`
`In the late 1990’s, ZOLL entered the data management software business, seeking to gain leverage in the pre-hospital market. Although
`these software solutions offer higher profitability, with margins significantly greater than the capital equipment products, and recurring
`revenues, the revenues generated by this business are relatively modest in comparison to defibrillator revenue. The addition of automatic
`external defibrillators (AEDs) in 2002 to our product portfolio, targeting the public access portion of the defibrillator market, again provided
`new opportunities to drive revenue growth through market expansion. We built market share with our introduction of cardiopulmonary
`resuscitation (CPR) feedback technology, although operating profitability was constrained by the highly fragmented nature of this new, highly
`competitive part of the market.
`
`Also in the early 2000’s, we recognized the growth opportunity associated with improving SCA outcomes beyond defibrillation and
`expanded our strategy to focus on the broader resuscitation opportunity. Expanding product offerings to address each of the links in the
`American Heart Association’s (AHA’s) Chain of Survival
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`(COS) was a key element of our strategy. In fiscal 2005, ZOLL acquired the AutoPulse Non-Invasive Cardiac Support Pump to offer enhanced
`®
`circulatory support and chest compression capability, and also acquired the Power Infuser fluid resuscitation product, which is used primarily
`®
`in military applications. In 2006, ZOLL completed a long-term plan to acquire the LifeVest wearable defibrillator business, which provides
`®
`proactive protection for patients at risk of SCA. In 2007 and 2009, ZOLL acquired therapeutic hypothermia technology and products that are
`used to provide therapeutic management of patients’ core body temperatures, including as part of post-resuscitation care. Throughout this
`period, ZOLL’s data management offerings were also expanded.
`
`We believe ZOLL’s focus on the much larger resuscitation market has opened up significant new, long-term market opportunities beyond
`our core business of defibrillation and pacing. The current defibrillation/pacing market is estimated to be approximately $1.5 billion annually.
`The annual U.S. market for the LifeVest, which achieved $105.8 million of revenue in 2011, has a long-term potential of growing to
`approximately $1.9 billion annually. In Germany, where we have begun sales of the LifeVest, the market opportunity is more than $500
`million. Similar, if not larger, market opportunities for the LifeVest exist in other countries like Japan. While our AutoPulse and temperature
`management products compete in markets of modest annual size currently, the potential worldwide markets for these products long-term are
`estimated at $600 million and $2.5 billion, respectively. These new markets are expected to develop over a number of years, accelerating as
`they expand from the initial indication and early adopters; clinical research will drive further use, offering increased growth opportunities.
`
`Equally important, we believe there is a significant opportunity to increase ZOLL’s profitability well above our historical levels due to the
`business models associated with these new markets. In particular, the LifeVest has been built as a service business relying on new and recurring
`physician prescriptions. The AutoPulse leverages our existing capital equipment distribution channels. Our temperature management solutions
`offer both a capital equipment product and a steady stream of recurring revenue from single-use, proprietary, disposable catheters used for each
`treated patient. These opportunities offer the potential of higher levels of profitability when compared to our historical levels. Finally, we
`expect that our broader focus on resuscitation will give rise to opportunities to develop or acquire additional resuscitation products to further
`leverage existing infrastructure.
`As ZOLL continues its expansion and its mix of businesses changes, we expect to realize greater opportunities for revenue growth. In
`addition, we believe there is significantly greater opportunity to improve our rate of operating profitability.
`
`The Clinical Need and Opportunity
`Sudden Cardiac Arrest and Resuscitation
`An estimated 450,000 people die from SCA annually in the United States. Approximately 1,000 people die of SCA every day outside of
`the hospital, and similar unexpected deaths occur in hospitalized patients at a rate of nearly 100,000 per year. Estimates of worldwide deaths
`exceed 1 million each year, making SCA one of the largest public health problems in the world.
`
`Resuscitation in this context refers to the restoration of normal physiological function in a patient who has had an episode of SCA. An
`individual’s chances of surviving SCA in the United States can fluctuate dramatically, depending on where he lives, and international results
`are similar. According to the AHA, the median survival-to-discharge rate after SCA is 6.4% in the United States. Medical interventions can
`treat the underlying disease, but many tens of thousands of lives could be saved with better quality resuscitation care.
`
`For SCA victims, time is the most critical element to survival. For every minute of delay in the restoration of effective cardiac function
`provided by defibrillation—the process of delivering electrical current to the heart to stop the fibrillation and permit the return of coordinated
`cardiac contractions—survival decreases by as much as 10%. According to the AHA, about 95% of SCA victims in the United States die, in
`many cases because lifesaving defibrillators arrive too late, if at all.
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`Providing temporary circulatory support with CPR is also critical to survival when SCA occurs. When appropriate care is provided in the
`form of CPR, early defibrillation, advanced life support (ALS), and continuing post-resuscitation care, as many as 50% of victims can survive
`SCA resulting from ventricular fibrillation. For some patients with a known and identified risk of SCA, immediate defibrillation with a
`wearable external defibrillator or implanted defibrillator can be highly effective, and the survival rate can approach 100%.
`
`Chain of Survival (COS)
`A useful metaphor to describe dependent relationships among different aspects of care contributing to survival is the “Chain of Survival.”
`The metaphor suggests that survival is dependent on the strength of each link and that any weakness in one link will break the chain and reduce
`the likelihood of survival. ZOLL’s resuscitation business strategy seeks to provide products that support and strengthen each link in the chain.
`
`Historically, the AHA’s COS defined the four key steps that rescuers should follow in treating SCA: early access, circulation,
`defibrillation, and advanced cardiac life support (ACLS). Historically, heavy emphasis was focused by the market on the defibrillation link in
`the chain. Over the past decade, the AHA’s view of this COS has emerged to place balanced emphasis on all links of the chain. In addition, the
`AHA has recently added a fifth link, post-resuscitation care. From our viewpoint, we believe the COS should include an additional link,
`preventive care, at the beginning of the COS, and utilize data collection and analysis to tie it all together.
`
`ZOLL’s version of the COS adds to the AHA’s 5-link chain Early Intervention as the first link, with data management and analysis tying all
`the links together.
`
`ZOLL Products as Related to the COS
`Early Intervention Link: The LifeVest Wearable Defibrillator
`ZOLL manufactures and markets the only wearable defibrillator, the LifeVest, worn by patients at risk for SCA. It provides protection
`during their changing medical condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician
`time to assess the patient’s long-term arrhythmic risk and implement appropriate treatment. Lightweight and easy to wear, it allows patients to
`return to their activities of daily living, while providing the peace of mind that they are protected from SCA. The LifeVest continuously
`monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart
`rhythm.
`
`The LifeVest is used for a wide range of indications, including following a heart attack, before or after bypass surgery or stent placement,
`as well as in patients with cardiomyopathy or congestive heart failure that places them at particular risk of SCA. In addition, the LifeVest is
`worn by patients awaiting an implantable defibrillator or after removal of an implantable device due to infection or other reasons. We believe
`there is a wide range of conditions that place patients at risk of SCA, for which the LifeVest could be an attractive treatment option.
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`The LifeVest is prescribed by a physician, typically a cardiologist, for a patient to wear during a period of temporary risk of a fatal
`arrhythmic event and is covered by most health plans in the United States, including commercial, state, and federal plans. Medicare provides
`coverage for the device rental for patients satisfying specific medical criteria and physician prescription requirements. As of November 2011,
`the LifeVest has been prescribed for more than 50,000 patients.
`
`The LifeVest durable medical equipment (DME) rental business model allows a physician to protect a specific patient from SCA by
`placing a medical order (i.e., prescription) directly with ZOLL. From this point, ZOLL manages the process, which includes fitting the LifeVest
`to the specific patient, educating the patient in the hospital, managing the medical documentation and insurance paperwork, and being available
`to address patient needs once discharged from the hospital.
`
`Potential applications of the LifeVest are broad, and the understanding of the factors placing patients at risk of SCA continues to evolve.
`Wearable defibrillation remains in the early stages of market development. We believe that there is ever-growing awareness of the LifeVest
`system as a treatment option for patients with SCA risk, and some physicians have incorporated the LifeVest into their practice standards.
`Despite this progress, market penetration remains low, and we believe that there is substantial opportunity for growth, to the extent that the
`LifeVest becomes accepted as a standard of care. Our ongoing commercial efforts focus on generating growth through clinical acceptance and
`research demonstrating patient benefit. In our model of potential acceptance across current coverage indications, we estimate that the
`LifeVest’s market in the United States has the potential to grow over many years to be approximately $1.9 billion annually.
`On August 4, 2011, Durable Medical Equipment Regional Carriers issued for comment draft revisions to the local coverage
`determinations with respect to Medicare reimbursement for AEDs and wearable defibrillators, including our LifeVest product. The draft
`revisions would limit the indications for Medicare reimbursement for the LifeVest product. These draft revisions are subject to public hearings
`and comments. The public comment period ended September 23, 2011. We have been advised that a decision could be made in the near future,
`although there is no statutory provision that defines a timeline for a decision. We believe that following the public hearing process, the current
`indications for Medicare reimbursement of the LifeVest product will not be limited; however, in the event the draft revisions were to become
`final, the draft limitations on the indications for Medicare reimbursement would have a material adverse effect on our LifeVest business.
`
`Key Differentiators
`The LifeVest is the only non-invasive wearable defibrillator on the market or commercially available today.
`
`Competition
`At the present time, there is no other device on the market similar to the ZOLL LifeVest. Other treatment options for physicians managing
`patients at high risk of SCA are an AED that requires bystander intervention by a family member or other person, or an implantable cardiac
`defibrillator (ICD) that requires surgery. Advances in implantable devices may someday provide for less invasive and less expensive therapies,
`such as subcutaneous implantable defibrillators, but the non-invasive nature of the LifeVest is a strong differentiator whenever SCA risk is
`considered temporary or changing. Finally, we believe that any interested, potential competitor would need to follow the same clinical and
`regulatory path that was required of the LifeVest to prove both safety and efficacy.
`
`CPR Link: AutoPulse
`CPR is a means to provide temporary circulation of blood for patients whose hearts have stopped beating. It can be a lifesaving
`intervention before the arrival or availability of skilled medical care. Public safety personnel, hospital medical personnel, and many others are
`required to be regularly trained in CPR. It consists of pressing
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`hard on the patient’s chest to a depth of at least 2 inches and at a rate of at least 100 times per minute, as is now recommended in the 2010 AHA
`guidelines. In some cases, ventilation with mouth-to-mouth breathing or mechanical ventilating devices should be provided. CPR is demanding
`physically and difficult to perform effectively, especially over long periods, and particularly when a patient needs to be moved or is in the back
`of a moving ambulance. When performed effectively, manual CPR can provide about 30% of normal blood flow to temporarily support a
`patient and preserve cardiac and brain function.
`
`ZOLL develops and markets the AutoPulse , an automated CPR device. The AutoPulse is battery operated and portable and is designed
`®
`for use in emergency medical services applications and in hospitals. It consists of a backboard and a simple disposable load-distributing band
`that fastens across a victim’s chest. The AutoPulse automatically calculates the patient’s shape and size for maximum
`compression/decompression benefit without the need to enter patient information or make manual adjustments. The AutoPulse improves the
`consistency of circulatory support, reduces the manpower required to perform CPR, and enhances the safety of rescue personnel in a moving
`vehicle.
`
`The AutoPulse compresses the entire upper chest (thorax) in a unique, semi-circumferential “hands-free” manner, circulating more blood
`than is customary with manual chest compressions. Studies of the device have shown that it can achieve coronary perfusion pressures equal to
`normal heart function in some patients. Additionally, it offers the benefit of providing CPR without the need for additional personnel who can
`provide the required manpower to sustain CPR over a long period. It also permits rescuers to focus on other lifesaving interventions while CPR
`is being done mechanically. At the end of fiscal 2011, there were approximately 6,000 AutoPulse units installed in hospitals and emergency
`services worldwide.
`
`More recently, significant attention has been directed to decreasing the risk of injury to rescuers when providing care during ambulance
`transport, since rescuers are often unrestrained while providing care and subject to serious injury in the event of a crash. The National
`Association of EMS Physicians, the International Association of Fire Chiefs, and a number of other interested parties have instituted safety
`initiatives. Providing manual CPR in a moving vehicle while unrestrained has been identified as an area of focus. The AutoPulse addresses this
`risk and facilitates the provision of CPR in a moving ambulance while the rescuers are safely restrained.
`
`Key Differentiators
`The AutoPulse uses a proprietary mechanism of action (e.g., a load-distributing band vs. sternal compression) to provide blood flow
`nearly equal to normal circulation.
`Research supporting the AutoPulse is more extensive than for any other mechanical chest compression device. The CIRC (Circulation
`Improving Resuscitation Care) trial compared the rates of survival to hospital discharge among patients who suffered out-of-hospital cardiac
`arrest and were treated with the AutoPulse to similar patients who received manual CPR. Initial results from CIRC were presented in November
`at the AHA Resuscitation Science Symposium (ReSS) in Orlando. Full results of the trial are expected to be published in 2012.
`
`The CIRC trial confirmed the impact that high-quality CPR can have on improving survival rates from SCA. The trial demonstrated that
`AutoPulse compressions are equivalent to high-quality manual CPR compressions. Manual CPR is the current standard for providing temporary
`circulatory support and oxygen delivery during cardiac arrest and has the highest treatment recommendation (Class I) in the AHA guidelines.
`However, delivery of manual CPR is often inconsistent. Significant decreases in quality have been seen after as little as one minute. The
`physical challenges associated with providing consistent manual CPR are recognized as a key factor in limiting CPR quality.
`
`Comparing high-quality manual CPR to AutoPulse CPR was a major focus of the CIRC trial. The protocol incorporated intensive training
`in manual CPR beyond that which is required in current guidelines; this training
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`was uniformly delivered to caregivers at all participating sites. It focused on minimizing hands-off time and frequent re-training, and it also
`closely tracked CPR fraction, the percentage of time that compressions are being delivered during resuscitation, which is a marker of CPR
`quality. Performance audits were also used to track CPR quality. The CPR fractions reported in both arms of the trial were very high for a large,
`multicenter prospectively randomized study. The resulting overall survival rate in the CIRC trial was also comparatively higher. Further,
`because of the high standards employed in the design of this trial, it is expected that the CIRC trial will set a new standard for research in the
`pre-hospital environment.
`
`We believe most EMS and hospitals are not able to provide the consistently high-quality manual CPR that was incorporated by extensive
`training and monitoring of staff in the CIRC trial. The trial clearly demonstrates that AutoPulse can be a safe and effective option for
`significantly improving CPR quality and providing improved outcomes. We believe many systems will incorporate the AutoPulse in their
`efforts to improve system performance. The AutoPulse will be especially effective when manual CPR performance is known to be lower than
`that reported in the CIRC trial.
`
`Competition
`Competitors offer devices that provide mechanical CPR. Other products duplicate the mechanism of manual CPR by compressing the
`sternum (i.e., the center of the chest.) Michigan Instruments, which originally pioneered the introduction of a mechanical CPR device known as
`a “Thumper,” manufactures the Life-Stat Model 1108, the newest model. It is sold through independent distributors in the United States and
`®
`internationally. The LUCAS device, similar to the Michigan Instruments device in terms of its mechanism of operation, was developed by
`Jolife AB, a privately held Swedish company, which was acquired in February 2011 by Physio-Control, a division of Medtronic, Inc.
`
`Defibrillation Link: Defibrillators
`Professional Defibrillators
`Professional defibrillators are used by health care professionals to treat patients experiencing SCA in all areas of health care. They are
`installed on all ambulances that provide ACLS and in virtually all health care facilities. In hospitals, defibrillators are typically placed on “crash
`carts” located in either every hospital unit and care area or placed strategically so they may be rapidly brought to a patient’s bedside by trained
`staff in the event of need.
`
`Professional defibrillators incorporate monitoring capabilities, so professionals can view the patient’s electrocardiogram (ECG), e.g. heart
`rhythm, and other vital physiologic information, such as oxygen saturation and blood pressure. The ECG helps to determine the patient’s
`treatment and may indicate the need for a defibrillating shock or external pacing. Another characteristic of professional defibrillators is that
`they permit the user to determine whether a shock is needed and to manually select the level of energy (“dose”), calculated in joules, used to
`defibrillate. They incorporate a wide range of energy outputs to cover the various defibrillating energy doses required for adult, pediatric, and
`neonatal patients. Disposable electrodes are typically used to deliver defibrillation and pacing therapy to patients. Professional defibrillators can
`also have paddles, held by the user on the chest to deliver defibrillation. In addition, professional defibrillators have the capability to perform a
`procedure called cardioversion, which is used to terminate an abnormal but non-life-threatening heart rhythm. The defibrillator delivers a shock
`at a specific point in the ECG, thereby “converting” the rhythm.
`
`ZOLL’s professional defibrillators include many selectable monitoring parameters to provide a detailed assessment of a patient’s
`condition. Examples of these parameters include: oxygen saturation levels (SpO ); 12-lead acquisition and analysis; invasive and non-invasive
`2
`blood pressure; end-tidal CO concentrations (EtCO ); carboxyhemoglobin saturation levels (SpCO); methemoglobin saturation levels (SpMet);
`2
`2
`and patient temperature.
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`Professional defibrillators may also incorporate some features that allow operation with automated ECG analysis and permit use as both
`an AED and manual device by different levels of care providers in either the organization or facility. These devices typically operate using
`either AC power or batteries.
`
`ZOLL currently offers many different models of professional defibrillators that are targeted to various use-specific needs.
`
`Our R Series models are offered mainly to hospitals. R Series defibrillators are Code-Ready , because they automatically monitor and
`®
`®
`test the complete defibrillator system—electronics, batteries, cables, and defibrillator discharge. If a component is not functioning, the monitor
`will display a message warning staff. The Code-Ready R Series offers multiple channels on a color monitor display. We supply it in versions
`®
`that allow for its use as both a manual defibrillator and an AED.
`
`The E Series models are primarily designed for use in EMS, where their rugged design and reliability match the rigorous environment
`®
`inherent with emergency medical calls. This device combines both manual defibrillator and AED capabilities, although it is primarily used as a
`conventional device.
`
`In 2010, we began marketing a new defibrillator called the Propaq MD for military applications, as well as air medical applications,
`®
`where its very small size, and light weight make it ideally suited for t