10-K 1 d10k.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 1, 2006
`
`OR
`(cid:133) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
`OF 1934
`FORTHE 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
`(Address of principal executive offices)
`(Zip Code)
`Registrant’s telephone number, including area code (978) 421-9655
`Securities registered pursuant to Section 12(b) of the Act:
`Name of each exchange on which registered
`
`04-2711626
`(I.R.S. Employer
`Identification No.)
`
`Title of each class
`
`None
`
`Securities registered pursuant to Section 12(g) of the Act:
`Common Stock, $.02 Par Value
`Stock Purchase Rights
`(Title of class)
`
`None
`
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:133) No (cid:95)
`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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K 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, or a non-accelerated filer. See definition of
`“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act (Check one):
`Large accelerated filer (cid:133) Accelerated filer (cid:95) Non-accelerated filer (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 2, 2006 was $254,574,045 based on a
`closing sales price of $26.34 per share as reported for the NASDAQ-composite transactions.
`The number of shares of the registrant’s classes of common stock outstanding, as of December 8, 2006 was 9,950,130.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive Proxy Statement dated on or about December 20, 2006 to be delivered to shareholders in connection with the Annual
`Meeting of Shareholders to be held January 24, 2007 are incorporated by reference into Part III.
`
`Philips Exhibit 2008
`Zoll Lifecor v. Philips
`IPR2013-00609
`
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`Table of Contents
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`Part I
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`Part II
`Item 5.
`
`ZOLL MEDICAL CORPORATION
`Annual Report on Form 10-K
`For the Year Ended October 1, 2006
`Table of Contents
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Submission of Matters to a Vote of Security Holders
`
`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
`
`Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity
`Securities
`Selected Financial Data
`Management’s Discussion and Analysis of Financial Condition and Results of Operation
`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
`
`Directors and Executive Officers of the Registrant
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions
`Principal Accounting Fees and Services
`
`Exhibits and Financial Statement Schedules
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`PART I
`Except for historical information, the matters discussed in this Annual Report on Form 10-K are forward-looking statements that involve risks
`and uncertainties. The Company makes such forward-looking statements under the provision of the “Safe Harbor” section of the Private Securities
`Litigation Reform Act of 1995. Actual future results may vary materially from those projected, anticipated, or indicated in any forward-looking
`statements as a result of certain risk factors. Readers should pay particular attention to the considerations described in Part I, Item 1A of this report
`entitled “Risk Factors.” Readers should also carefully review the risk factors described in the other documents that the Company files from time to
`time with the Securities and Exchange Commission. In this Annual Report on Form 10-K, the words “anticipates,” “believes,” “expects,” “intends,”
`“future,” “could,” and similar words or expressions (as well as other words or expressions referencing future events, conditions or circumstances)
`identify forward-looking statements.
`Item 1. Business.
`Overview
`ZOLL Medical Corporation (ZOLL or the Company), a Massachusetts corporation incorporated in 1980, develops technologies and software
`that help clinicians, emergency medical services (EMS) personnel and lay rescuers advance the practice of resuscitation.
`To understand resuscitation, it is important to first provide background information about:
`•
`The anatomy of the heart;
`Sudden cardiac arrest (SCA) and how rapid, life-saving interventions can help SCA patients;
`•
`•
`The different arrhythmias that can lead to SCA;
`•
`The issue of traumatic injury and its effects that can also lead to SCA;
`•
`Recent developments and new research in the areas of emergency cardiovascular care and the performance of cardiopulmonary
`resuscitation (CPR); and
`• A definition of the resuscitation technology market.
`
`Anatomy of the Human Heart
`The normal human heart has four chambers, and expands and contracts more than 100,000 times each day. The two smaller, upper chambers
`are the atria, and the two larger, lower chambers are the ventricles. The walls of the atria and the ventricles are made up of cardiac muscle, which
`contracts rhythmically when stimulated by an electrical current. Normally, the heartbeat starts in the right atrium when a specialized group of cells
`sends an electrical signal. This signal spreads through the atria and then moves to the ventricles. As a result, the atria contract a fraction of a second
`before the ventricles. This exact pattern must be followed to ensure that the heart beats properly. This contraction and relaxation of the four
`chambers pumps blood to the lungs and the rest of the body.
`Sudden Cardiac Arrest
`Sudden cardiac death results from the sudden, abrupt loss or disruption of heart function. This abrupt loss of function, also known as sudden
`cardiac arrest (SCA), causes lack of blood flow to vital organs. SCA results in a loss of blood pressure, pulse, and consciousness. Most commonly,
`SCA is caused by an abnormal heart rhythm called ventricular fibrillation, which occurs when the heart beats too rapidly and/or chaotically, or not
`at all (cardiac standstill from other non-fibrillation dysrhythmias such as pulseless electrical activity).
`According to the Center for Disease Control and Prevention, there are an estimated 460,000 deaths from SCA annually in the United States,
`and approximately 1,000 people die of SCA every day. SCA strikes without
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`warning and can kill its victims within minutes; most victims have no prior symptoms. Many of these deaths are from ventricular fibrillation. For
`SCA victims, time is the most critical element for 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 American Heart Association (AHA), more than 95% of SCA victims in the
`U.S. die, in many cases because life-saving defibrillators arrive too late, if at all.
`Different Arrhythmias that Can Lead to SCA
`Arrhythmias are abnormal rhythms of the heart caused by insufficient circulation of oxygenated blood, drugs, electrical shock, mechanical
`injury, disease, or other causes. The three types of major arrhythmias are ventricular fibrillation and tachycardia; atrial fibrillation and flutter; and
`symptomatic bradycardia. It is possible for a patient to experience more than one type of arrhythmia during SCA. In these situations, it is important
`for trained rescuers to have equipment that has defibrillation and pacing capabilities, as well as technology that can assist with CPR performance.
`Ventricular Fibrillation. Ventricular fibrillation is a condition in which disorganized electrical activity causes the ventricles to contract in a
`rapid, unsynchronized, and uncoordinated fashion. When this occurs, an insufficient amount of blood is pumped from the heart. Ventricular
`fibrillation is the most common arrhythmia thought to cause SCA. The onset of ventricular fibrillation often occurs without warning and causes the
`heart to cease pumping blood effectively. This sudden stopping of the heart is known as cardiac arrest, which is the cause of sudden cardiac death.
`The only accepted treatment for ventricular fibrillation is defibrillation. In emergency situations, external defibrillation was conventionally
`administered through hand-held paddles placed on the patient’s chest. However, external defibrillation is now more likely to be administered
`through disposable adhesive electrodes, which are believed to be safer and easier to use than paddles.
`According to the AHA, early defibrillation of ventricular fibrillation is the single most effective intervention in the rescue of a victim of SCA.
`Each minute of delay in returning the heart to its normal pattern of beating decreases the chance of survival by 7% to 10%. Furthermore, there is an
`increasing body of evidence that other actions, in addition to defibrillation, must occur to maximize the chance of a successful resuscitation. These
`actions comprise a “Chain of Survival” consisting of early access, early CPR, early defibrillation, and early advanced care.
`Atrial Fibrillation. The AHA estimates that close to 2 million Americans suffer from atrial fibrillation. Atrial fibrillation is a condition in
`which disordered electrical activity causes the atria to contract in a rapid, unsynchronized and uncoordinated fashion. This inefficient contraction
`results in a smaller amount of blood entering the ventricles, which in turn results in an insufficient level of circulation. Since blood is not pumped
`completely out of the atria, the blood can pool and clot. While not immediately life threatening, atrial fibrillation can lead to significant health
`threats, such as stroke. Over time, poorly functioning atria can also cause the ventricles to work harder, wear out sooner, and eventually lead to
`cardiac arrest.
`Common forms of treatment for atrial fibrillation include cardioversion and drug therapies. During cardioversion, a defibrillator delivers
`electrical current that is synchronized with a patient’s heartbeat to return the atria to a normal rhythm. Cardioversion is usually an elective therapy,
`scheduled and performed in a controlled environment. All of ZOLL’s manual defibrillators include cardioversion capability.
`Bradycardia. Bradycardia is a condition in which the heart beats too slowly. The principal therapies for the emergency treatment of
`bradycardia are drugs and temporary cardiac pacing, either or both of which may be used to stimulate effective cardiac contractions and restore
`circulation. Cardiac pacing utilizes an electrical pulse to stimulate the patient’s heartbeat. For the emergency treatment of bradycardia, there are two
`primary techniques
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`for temporary pacing: invasive endocardial pacing, in which a wire is inserted directly into the heart to provide the electrical stimulus; and non-
`invasive temporary pacing, which uses gelled electrodes applied to the patient’s chest to conduct an electrical stimulus. Non-invasive temporary
`pacing is an option on most ZOLL defibrillators and is recommended as the first intervention for bradycardia in the AHA’s resuscitation protocols.
`Traumatic Injury and its Effects
`Trauma is widely recognized as a major health problem and the third leading cause of death in the U.S. In 2002, there were over 161,000 fatal
`injuries in the United States. Severe injury is the number one killer of both children and young adults up to age 44. As a disease of young people, it
`is also the leading cause of life years lost. The leading causes of death following traumatic injury are brain injury, blood loss, and organ failure from
`excessive inflammation. SCA can also occur in trauma patients.
`In 2000, a workshop known as the Post-Resuscitative and Initial Utility in Life-Saving Efforts (PULSE), convened to address resuscitation
`research in the areas of SCA and injury from trauma. The PULSE report, published in Circulation, noted that earlier and better CPR, rapid
`defibrillation, and earlier hemorrhage control will lead to improvements in survival. One recommendation made was that “technology-based
`methodologies for monitoring and performing resuscitation should be improved,” along with the use of “new and novel devices to produce blood
`flow during cardiac arrest.”
`Recent Developments and New Research in the Areas of Emergency Cardiovascular Care and CPR Performance
`Officially named the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care,
`the 2005 AHA Guidelines provide recommendations about how lay rescuers and healthcare providers should resuscitate victims of cardiovascular
`emergencies, including SCA, which is fatal within minutes of onset, if not treated with CPR and/or defibrillation. The Guidelines, which began in
`the early 1990s, are updated every five years to reflect advancements in resuscitation research and the science. The European Resuscitation Council
`(ERC) also releases updated Guidelines every five years in conjunction with the AHA.
`A major theme in the latest release is the emphasis on performing effective, high-quality CPR. According to the AHA and the ERC, the new
`focus resulted from studies that showed that “blood circulation increases with each chest compression in a series and must be built back up after
`interruptions.” In addition, the authors of the Guidelines noticed a “striking” difference between data showing the critical role of early, high-quality
`CPR in increasing cardiac arrest survival rates, and data showing that few victims of cardiac arrest receive CPR—with even fewer receiving high-
`quality CPR.
`The AHA and the ERC also maintain that early CPR can quickly return oxygen-rich blood to the heart and throughout the body. In addition,
`when CPR is performed in conjunction with defibrillation, which is indicated in approximately 50% of collapsed victims, it can help restore normal
`heart rhythm, which can double a victim’s chance of survival, especially for the 75-80% who suffer cardiac arrest at home. Indeed, without
`immediate intervention, an SCA victim has only about a 5% chance of survival. But if CPR and defibrillation are provided within the first three
`minutes after collapse, survival rates can reach as high as 75%.
`The Resuscitation Technology Market
`The Company develops technologies that help clinicians, EMS personnel and lay rescuers advance and improve the practice of resuscitation.
`In order to advance resuscitation practices, the Company believes it must provide technology that addresses various clinical interventions that are
`part of resuscitation efforts. These include the following:
`Pacing, which helps regulate the heartbeat when the heart’s natural native pacemaker is not fast enough, or if blocks in the heart’s
`•
`electrical system prevent impulses from reaching the ventricles. ZOLL has been a leader in pacing technology since its first commercial
`product was released in 1984.
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`•
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`•
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`• Defibrillation, which uses an electrical current to stop the chaotic rhythm so the heart can reestablish its normal rhythmic beating. It is
`used in patients experiencing dangerous arrhythmias or SCA. ZOLL is also a leader in the area of defibrillation, and its products have
`been deployed and accepted by professional healthcare personnel worldwide.
`Circulatory support and assistance for manual CPR performance, which involves helping to circulate oxygenated blood throughout a
`patient’s body when the heart in unable to do so. This is accomplished through manual chest compressions (pushing on the chest) and
`forcing air into the lungs of a patient via rescue ventilation. ZOLL’s Real CPR Help™ technology offers real-time feedback to rescuers so
`that they can monitor and improve CPR performance. ZOLL was the first manufacturer to offer this feedback mechanism in an automated
`external defibrillator (AED), which is a portable device that analyzes the heart’s rhythm and, if necessary, allows rescuers to deliver an
`electric shock to an SCA victim. ZOLL now also offers Real CPR Help technology in most of its professional defibrillators.
`• Automated circulatory support, which automates the process of performing chest compressions rather than having rescuers perform them
`manually. This intervention can help decrease interruptions, while increasing the quality of chest compressions (i.e., maintaining proper
`rate and depth). The ZOLL AutoPulse® helps healthcare professionals in pre-hospital and in-hospital settings automate the process of
`delivering CPR chest compressions.
`Fluid replacement, which provides circulatory support through intravenous fluid administration that is the primary treatment for
`hypovolemia. Hypovolemia, the decrease in the volume of circulatory blood, is a common condition found in trauma patients and can
`lead to shock, SCA and/or death. Trauma is widely recognized as a major health problem and is the third leading cause of death in the
`U.S. ZOLL’s Power Infuser® has been widely accepted by the U.S. military for fluid resuscitation, and the Company is now pursuing the
`EMS market with this product.
`• Data management, which involves software that automates the documentation and management of both clinical and non-clinical
`information in pre-hospital and hospital settings. These products can work together in an integrated system so that information can be
`captured, documented, and managed throughout the care of a cardiac arrest patient, from the field to the hospital. ZOLL information
`management solutions involve: electronic documentation and data gathering (e.g., data from the 911 call, to patient vital signs, to billing
`information); aggregation of this type of data; and the ability to review and analyze information for remedial training/continuous quality
`initiatives (CQI) or other strategic planning efforts.
`• Ventilation, which involves air entering and leaving the lungs, allowing the body to expel carbon dioxide and oxygenate blood that
`circulates through a patient’s body. While ZOLL does not currently offer a product that specifically address this aspect of resuscitation,
`the Company regards it as a future growth area.
`• Hypothermia, which involves cooling an SCA patient a few degrees (i.e., to 91.5°F or 33°C), may play a role in helping resuscitated
`patients recover. The 2005 AHA Guidelines suggest that mild hypothermia may be beneficial to neurological outcome without significant
`risk of complications. While ZOLL does not currently offer a product that specifically address this aspect of resuscitation, the Company
`regards it as a future growth area.
`ZOLL’s Core Technology
`The Company’s line of resuscitation products include three core technologies that are implemented throughout the product line. They include:
`•
`Rectilinear Biphasic™ waveform, which is utilized in its line of professional defibrillators and AEDs;
`External pacing technology in the Company’s professional defibrillators; and
`•
`•
`Real CPR Help technology in its professional defibrillators and AEDs.
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`ZOLL’s Biphasic Waveform. External defibrillators deliver current over time to the heart, which results in a defined waveform shape. One
`type of waveform in use today is monophasic, meaning that current is delivered in a single pulse that flows in one direction. Another type is the
`biphasic waveform, which, in contrast, delivers current that first flows in a positive direction for a period of time and then reverses direction so that
`it flows in a negative direction.
`ZOLL’s primary competitors offer biphasic waveforms using the same general waveform shape. However, the Company has developed a
`uniquely shaped biphasic waveform, which achieves higher efficacy at lower current levels than monophasic waveforms. ZOLL’s biphasic
`waveform reduces the heart’s exposure to high peak current, which helps to reduce risk to the patient, while increasing efficacy. In addition,
`ZOLL’s biphasic waveform keeps the waveform shape and duration constant over a wide range of patients whose differing physiologies affect the
`conduction of current, which also helps to improve efficacy.
`External Pacing Technology. In 1984, the Company introduced a non-invasive temporary pacemaker based on the research of Paul M. Zoll,
`M.D., one of the Company’s founders. This technology, which was the cornerstone of the pacing capability in ZOLL’s line of hospital defibrillators,
`has been clinically shown to offer superior capture rates and provide lower mean capture thresholds. It also allows better patient tolerance of
`external pacing due to reduced current requirements and large surface area electrodes that deliver the current. In 1992, the AHA elevated non-
`invasive pacing to the initial treatment of choice for certain serious patient conditions (Class 1 for profound bradycardia). This means that external
`pacing should be performed on patients because of the clear benefit, with little risk. The Company believes that it was the market leader for this
`technology at that time, and remains so today.
`Real CPR Help Technology in its Professional Defibrillators and AEDs. In 2002, with the launch of the AED Plus™, ZOLL introduced
`technology that allows rescuers to see and hear how well they perform the rate and depth of chest compressions during a cardiac arrest event. Along
`with the AED Plus, ZOLL has integrated this Real CPR Help technology into the AED Pro® and the newly introduced R Series™. The Company
`plans to add this technology to its other defibrillator products, including the E Series® and M Series®.
`ZOLL’s Line of Resuscitation Products
`The Company’s resuscitation products fall into the following categories:
`•
`Professional defibrillators, which include the M Series, E Series, newly introduced R Series, and the LifeVest® wearable defibrillator,
`which is prescribed by cardiologists;
`• AEDs that assist with manual CPR efforts, which include the AED Pro and the AED Plus;
`• Disposable electrodes used with ZOLL’s line of defibrillators;
`•
`The AutoPulse Non-invasive Cardiac Support Pump, used to automate the process of delivering chest compressions;
`• Documentation and information management, which include RescueNet™ for EMS personnel and CodeNet® for hospitals; and
`•
`Fluid replacement utilizing the ZOLL Infuser®, also known as the Power Infuser® in the military market.
`
`Professional Defibrillators
`A professional defibrillator is used by trained healthcare professionals to defibrillate a person in SCA. Healthcare professionals can review a
`patient’s heart rhythm, and manually determine and set the level of energy (known as Joules) used to defibrillate. ZOLL’s professional defibrillators
`also include monitoring parameters (e.g., oxygen saturation levels, and blood pressure, among others) to help assess a patient’s condition.
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`M Series Defibrillators. The M Series family of products was designed for both the hospital and pre-hospital markets. ZOLL currently sells 11
`models of this device, including a model designed for critical care transport and a model tested and certified for use on military aircraft.
`The large number of models reflects user selection and need for various features and options such as shock advisory capability, 12-lead ECG,
`diagnostic operation, or data transmission features. The M Series defibrillator is the Company’s best-selling product to date. It has been selected as
`the standard device by institutions such as Brigham and Women’s Hospital, The Mayo Clinic, Scripps Health System, The Johns Hopkins Hospitals,
`the U.S. Armed Forces, and the German Army. ZOLL believes that the M Series clinical superiority and range of features have helped maximize
`customer retention by reducing the need for operator retraining and enhancing operator confidence.
`M Series defibrillators were designed to allow customers to add features depending upon their individual needs. Other features available
`include the following:
`• Complete Data Management. A code marker system follows protocols established by the AHA, and it allows complete documentation
`of an event with a “one touch” data annotation feature. The record made of the event includes all information collected by the defibrillator
`and can be upgraded to include an optional voice recording. All of this data is stored on a removable data card. It can also be transmitted
`electronically to other devices via a serial port, built-in modem, and Bluetooth® wireless communications, allowing significant flexibility
`in moving data for purposes of remote consultation and recordkeeping. ZOLL also developed software applications for the archiving and
`trending of this information.
`• Diagnostic 12-lead ECG with Interpretive Statement. The 12-lead feature enables a user to get a diagnostic ECG tracing, or a view of
`the heart’s electrical activity. 12-lead is used to provide rapid and early identification of myocardial infarction, commonly called a heart
`attack, in the pre-hospital setting. ZOLL pays royalties to GE Medical Systems (GEMS) on each 12-lead analysis program sold.
`Interface to GEMS MUSE Cardiology Information System. The M Series and E Series defibrillators communicate directly with the
`GEMS Information Technologies MUSE cardiology information system. This MUSE interface provides direct communication of pre-
`hospital 12-lead ECG data into GE’s MUSE information system, eliminating the need for a dedicated receiving station or gateway.
`Pulse Oximetry. Pulse oximeters determine the oxygen saturation levels in blood (SpO2), allowing a rapid identification of potential
`problems in the cardiopulmonary system. Since pulse oximeters can help detect the onset of cardiovascular incidents, pulse oximetry is
`now widely used in both hospital and pre-hospital settings when monitoring patient vital signs. While conventional pulse oximeters do
`not perform well during patient motion or in intense light, ZOLL uses Masimo Corporation’s patented technology, which is designed to
`overcome these technical problems. ZOLL purchases circuit boards and sensors from Masimo Corporation. The Company has a non-
`exclusive license to use the patented technology incorporated in these parts, which are incorporated, in turn, into ZOLL’s products.
`• Capnography. Capnography, also known as EtCO2, is the measurement of the amount of carbon dioxide being exhaled, allowing for
`rapid identification of potential problems in the cardiopulmonary system. ZOLL purchases circuit boards and sensors from Respironics
`Novametrix LLC that provide this feature. In October 2004, ZOLL announced new plug-and-play mainstream and side stream EtCO2
`monitoring capability designed for ease of use in pre-hospital settings. Users can easily select the optimum CO2 monitoring method based
`on the patient’s condition.
`• Non-invasive Blood Pressure Measurement. ZOLL developed a non-invasive blood pressure measurement capability, also known as
`NIBP, and integrated it into the M Series and E Series defibrillators. ZOLL purchases circuit boards, hoses, and cuffs from SunTech
`Medical to provide this feature.
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`E Series Defibrillator. The E Series family of products is a line of defibrillators for the pre-hospital environment, which also offers a range of
`similar monitoring and data features that are also available on the M Series. The E Series was launched in July 2005 and began shipping in
`September 2005. Designed specifically for the EMS market, the E Series offers several unique features that will allow the Company to expand the
`EMS portion of the pre-hospital market. The E Series is targeted towards Advanced Life Support providers, and it includes all of the features of the
`M Series, as described above. ZOLL believes that the E Series is the only rugged, durable defibrillator available today that offers the following:
`• Designed to Meet the Needs of the EMS Environment. A suitcase-style with a protective roll cage allows customers to carry or store
`the device more easily. It also offers a Rapid Cable Deployment System™ that helps manage all the parameter cables, allowing for faster
`deployment.
`TriMode Display. The E Series allows users to view the screen under virtually any lighting conditions.
`Improved Event Synchronization. The E Series is equipped with a built-in GPS clock that allows customers to automatically
`synchronize all dispatch, defibrillator, and intervention call times, improving overall data accuracy.
`R Series Defibrillator. Designed for hospitals, the Company believes that the R Series, announced in November 2006, sets a new standard for
`simplicity and operational readiness, which will help improve in-hospital resuscitation efforts. Moreover, the R Series simplifies and speeds up
`deployment of pacing and defibrillation therapy. It also offers tools that can help clinicians improve CPR performance. Finally, the R Series offers
`automated checks designed to help maximize the readiness of the R Series for clinicians. The R Series offers a range of new features:
`The OneStep System. The OneStep System provides a single cable for pacing, monitoring, and defibrillation. It also includes one
`•
`electrode set through which clinicians can monitor, pace, defibrillate, and get real-time feedback on chest compressions, also known as
`Real CPR Help.
`Tools Help Users Improve CPR Performance. More than half of in-hospital codes involve non-shockable rhythms. In such cases, the
`only treatment for such rhythms is high-quality CPR, with minimal interruptions. The R Series offers See-Thru CPR™ functionality that
`helps clinicians minimize interruptions in CPR performance. While viewing the ECG on a monitor/defibrillator, artifact (i.e., “noise”)
`from chest compressions make it difficult to discern the presence of an organized heart rhythm unless compressions are halted. See-Thru
`CPR filters out this artifact so clinicians can view an underlying rhythm without stopping chest compressions.
`In addition to See-Thru CPR, the R Series offers a visual aid known as the CPR Index™ that allows clinicians to see how well they are
`performing the rate and depth of chest compressions in real time. This Index, along with audible prompts (e.g., “Push Harder” and “Good
`Compressions”), helps clinicians improve CPR performance by integrating rate and depth into a single indicator on an easy-to-read
`display. With this feedback, clinicians know how well