MEASURE THE DIFFERENCE. Functional diagnostics for electrophysiology and interventional cardiology

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1 MEASURE THE DIFFERENCE Functional diagnostics for electrophysiology and interventional cardiology

2 02 MEASURE THE DIFFERENCE. SMART. PRECISE. RELIABLE. SCHWARZER CARDIOTEK has a long history in the development of diagnostics for cardiology. Today, our systems refl ect the continuous cooperation of cardiologists and scientists, combining state-ofthe-art research and development to deliver the smartest, most reliable and precise hardware and software solutions to our customers.

3 03 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. TRADITION MEETS INNOVATION With more than 1,000 hemodynamic installations, more than 800 installed EP systems worldwide and a successful market presence of more than 60 years, Schwarzer Cardiotek is synonymous with a solid partnership in the field of cardiology. We aim to be a leading player in interventional cardiology by providing intelligent insights into cardiac function and by delivering best-in-class quality and service to our customers and partners to enhance the care of their patients. _ Frank-Peter Klein President & Chief Commercial Officer Innovations in medical technology occur when a deep understanding of clinical practice is coupled with creativity and technological vision. Through a close, trusting collaboration with our customers and partners, our development team work to create innovative solutions to improve the clinical workfl ow. _ Michael Späth M.D., President & Chief Operations Officer Schwarzer Cardiotek Many years of experience and comprehensive expertise in the fi eld of modern cardiology diagnosis YEARS OF EXPERIENCE SINCE ,000 + HEMODYNAMIC SYSTEMS INSTALLED ELECTROPHYSIO- LOGIC SYSTEMS INSTALLED

4 04 MEASURE THE DIFFERENCE. EXCELLENT SIGNAL QUALITY We do not amplify the noise but the signal. The Schwarzer Cardiotek preamplifier technology offers brilliant signal quality. SYSTEM INTEGRATION AND SECURITY Taking the rising number of IT systems into account, Schwarzer Cardiotek ensures the seamless integration of your systems into any environment. High reliability and failure safety is extremely important to us. INTUITIVE OPERATION SUPPORTS WORKFLOW The Schwarzer Cardiotek functional keyboard offers access to the essential operating functions at a glance even in critical situations. Optimal support of workflow is also the core feature of our software solutions. Unique in the fi eld of cardiology: the Schwarzer Cardiotek keyboard.

5 05 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. HIGHEST QUALITY STANDARDS Assuring compliance with highest quality standards is the companyʼs top priority. We are certified according to EN ISO 13485:2012 and Annex II of the Medical Device Directive 93/42/EEC. The EP-TRACER has received FDA 510(k) clearance.

6 06 MEASURE THE DIFFERENCE. SMART. PRECISE. RELIABLE. EXPERT S OPINION Prof. Dr. Thomas Paul Director of the Department of Pediatric Cardiology and Intensive Care Medicine, Göttingen University Hospital The efficiency of the workflow shortens the examination and thus significantly reduces the strain on both the patient and the clinician. In pediatric cardiology we perform the complete range of diagnostic and catheter-based interventional procedures. In addition to this, we perform invasive diagnosis and treatment of every type of infantile cardiac arrhythmia. We have utilized the Schwarzer Cardiotek heart-catheter monitoring station since 2002 and throughout this time we have benefi ted from the company s many years of experience and the high quality of the product. In pediatrics we fi nd the precision of the equipment especially valuable.

7 07 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. HEMODYNAMICS evoseries Precise recording, measurement and calculation Our high-end cath lab systems, equipped with comprehensive functions, meet all expectations for functional diagnostics in heart catheterization including a dedicated version for pediatrics. The evoseries offers both automatic and manual measurement capabilities of curve segments, which can either be measured simultaneously or individually. Pullback curve segments are automatically assigned. In addition, there is also the option of manual correction of measurement points. Hemodynamic gradient and ECG recordings are saved in the background and can always be recalled and evaluated (Full Disclosure File). The integrated patient archive ensures the availability all reports containing waveforms and patient data, while the functional redundancy within the dual-computer design provides increased security against malfunction (depending on the model). Standard Interfaces Schwarzer Cardiotek evoseries stands for optimal system integration. The functionalities can be integrated into all DICOM structures, independently of the manufacturer. Thus, all advantages of the evo system can be accessed from any clinical environment. Heart Catheter Lab HIS Worklist / DICOM-UID MPPS Billing Report PDF Patient Stay Doctors Appointment HL7 Health Level 7 Perfect interaction Clinical communication structures and Schwarzer Cardiotek evo system. Runs DICOM- UID Report PDF DICOM- UID evo system Worklist File Transfer COM Server DICOM Digital Imaging and Communications in Medicine Runs PACS DICOM- UID DICOM Viewer Stock

8 08 MEASURE THE DIFFERENCE. ELECTROPHYSIOLOGY EP-TRACER Portable EP-TRACER The EP recording system with built in stimulator and unique signal quality 12 surface ECG channels 20, 52 or 84 bipolar intracardiac channels 6 auxiliary channels (e.g. for invasive blood pressure) Built-in stimulator with 2 outputs User selectable stimulation on intracardiac channels without external wiring Minimal space requirement USB connection to PC Isolated power supply The EP-TRACER stands for unmatched signal clarity giving it the reputation as one of the best preamplifiers available in the market. The signal quality and easy handling of the integrated stimulator ensure efficient and fast work. The EP-TRACER is available in several versions for all stationary and mobile applications. The ability to transfer data from all common ablators ensures consistent documentation of diagnosis and intervention. EXPERT S OPINION Prof. Josep Brugada Servei de Cardiologia, Institut Clínic del Tòrax Hospital Clínic, University of Barcelona EP-TRACER MobileCart The easy handling of the EP-TRACER Portable and its full integrated stimulator enables me to work effectively and fast. I have used the electrophysiological systems of Schwarzer Cardiotek for more than 20 years. I choose this system for the combined benefi ts of excellent signal quality and portability. The compact system EP-TRACER Portable is run through a laptop allowing me full portability without compromising on quality, and thus I can bring it with me wherever I require; whether within Spain or on humanitarian missions abroad. EP-TRACER Stationary

9 09 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. COMBINED SOLUTIONS HEMO-EP evoduo The combined system for hemodynamic and electrophysiological applications Effective use of your facilities Integration of hemodynamics and electrophysiology in a single workstation Unparalleled flexibility Combined benefits of both systems The evoduo platform combines two systems: the hemodynamic functionality of the evoseries and a modular extension to the EP-TRACER for electrophysiology. The evoduo is available in three model variants. Depending on your needs you can choose between the standard version, the model for superior requirements in adult cardiology or a version for pediatric cardiology. All three versions are available with 38, 70 or 102 intracardiac channels. EP-TRACER 102

10 10 MEASURE THE DIFFERENCE. CARDIOLOGY INFORMATION SYSTEM cardworks The cardiology information system for the cardiac cath lab Complete integration of findings and reports with the BQS data management system in the clinical standards workflow Out-of-the-box report generation, without additional user interaction Graphical documentation of indications and interventions in heart, coronary and peripheral arteries cardworks is a flexible information system that focuses on the work processes in the cardiac cath lab. Through its modular design, cardworks can be utilized for either single workstations or multiple networked measuring stations, with inputs from multiple user profiles in a diverse range of clinical settings. Integration with the hemodynamic measurement station and the connection via standard interfaces to the HIS and other sub-systems guarantees the immediate availability and consistent distribution of all the required information. Versatile add-on modules Our diverse range of add-on modules supports the user to create the most effi cient workfl ow. They enable: generation of detailed graphical documentation of indications and interventions in the coronary and peripheral arteries management of materials schedule planning automatic text generation (based on the recorded indications and fi ndings) statistical analysis of procedural and patient-relevant data, material use and staff productivity

11 11 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. cardworks offers fully automated reporting along with a complete package of interfaces that provide a smooth, personalized workfl ow for each user. Detailed documentation Aside from collecting and maintaining all patient-related and procedural data required for documentation, billing and statistical analysis, cardworks automatically displays all hemodynamic measurements (such as pressures and oxygen saturations) on an interactive heart graphic, thus simplifying procedure monitoring. These features, combined with the integration of ICD10, OPS and BQS databases, allow for the automatic generation of a detailed report with just a few clicks. Comprehensive procedure history An intuitive Windows-based menu system allows all relevant events to be quickly documented. All the materials and medication used (including the amount of contrast medium used), the type of interventions performed and the time required, can all be easily documented with just a few clicks.

12 12 MEASURE THE DIFFERENCE. THE PERFECT SOLUTIONS FOR YOUR HEMODYNAMICS evonatal For pediatric cardiology evosuperior For highperformance cardiology evoprime+ Comprehensive functionality with outstanding comfort evoprime Comprehensive functionality in a compact package evoelement Entry-level version with all basic functions for the modern cath lab Blood pressure amplifier Auxiliary channels (incl. invasive blood pressure) EP-amplifier channels (EP-TRACER 38, 70 or 102) Bipolar intracardiac channels Integrated stimulator channels Backup pacing Monitors Functional keyboard Automatic hemodynamic measurement Manual hemodynamic measurement Gradient calculation Uptime concept based on dual CPU utilization Pediatric cardiology Load stages control

13 13 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. NEEDS COMBINED SOLUTIONS HEMO-EP ELECTROPHYSIOLOGY eco c Small solution for right heart diagnostics evoduo natal Combined system, two-monitor version, also for pediatrics evoduo superior Combined system, two-monitor version, dual computing concept evoduo prime Combined system, two-monitor version EP-TRACER Portable Portable EP recording system with built-in stimulator EP-TRACER MobileCart / MobileDesk Mobile EP recording system with built-in stimulator EP-TRACER Stationary EP recording system with built-in stimulator , 70, , 70, , 70 38, 70, , 70, , 70, , 52, 84 20, 52, 84 20, 52 20, 52, 84 20, 52, 84 20, 52,

14 14 MEASURE THE DIFFERENCE. ADDITIONAL PRODUCTS For improved diagnostics EASI LEAD SYSTEM Single use electrodes In the cath lab, the significance of hemodynamic results depends highly on the quality of ECG signals. The EASI lead system has been clinically validated and can be used for ECG monitoring. By using a special algorithm and the appropriate positioning of only 5 electrodes, data for the 12 standard leads is collected. This concept is validated especially for interventional use and enables the user to monitor special chest wall leads without interfering with x-ray images. The adhesive electrodes are fi rmly attached to the patient and connected to the corresponding leads, reducing transmission resistances and increasing signal quality. The single use product must be replaced for each patient. FRACTIONAL FLOW RESERVE Evaluation without additional monitors and systems The optional integrated FFR measurement enables the assessment of flow reserve without additional monitors and systems. The Schwarzer Cardiotek evo measuring station allows the connection of all commonly used FFR systems. In some systems, the distal pressure values are transmitted wirelessly to the Schwarzer Cardiotek pre-amplifi er, thus increasing freedom of movement at the operating table. Furthermore, all hemodynamic measurements (including the FFR value) are integrated in a single system and documented in a single cardiac catheterization report. MULTI-PARAMETER MODULE FOR PATIENT MONITORING Philips IntelliVue X2 Multi-Parameter Module The module transmits the numeric values to the hemodynamic measuring station. Operation is possible at the measuring station in the control room and directly via the multi-parameter module in the examination room (the display is freely confi gurable). The monitor can also operate in battery mode for up to three hours in mobile use, which permits the secure and straightforward monitoring of patients before and after an examination in the heart catheter laboratory. The following parameters can be continuously monitored by the module, displayed on the hemodynamic monitors in the control room and examination room, and documented in the heart catheter report: Heart rate Temperature Oxygen saturation Non-invasive blood pressure (NiBP) Cardiac output with the thermodilution method Respiration CO 2 measurement in the main or side stream

15 15 SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE. SERVICES AND SUPPORT Our technologies are designed to help improve medical services and restore health. To enable the most efficient and effective use of our high-quality measuring stations and software solutions, we provide an extensive service and maintenance support strategy. Our service management covers all key aspects required for the optimal utility of our products, including documentation, quality management, maintenance, safety checks, repairs, instruction and training. Technical Support Providing you with excellent technical support is especially important to us. At Schwarzer Cardiotek we always deliver outstanding services to our customers. You have access to a highly qualified and experienced technical support team that will always do its very best to assist and advise you. Trainings Training plays a crucial role, enabling you to take full advantage of the technical capabilities of your recording system in practical application. We offer customized application training for our products in the areas of hemodynamics, electrophysiology and cardiac information systems. For more information visit

16 Hotline: +49 (0) Schwarzer Cardiotek GmbH Im Zukunftspark Heilbronn Germany Phone +49 (0) Fax +49 (0) CardioTek B.V. Amerikalaan AE Maastricht-Airport The Netherlands Phone +31(43) Fax +31(43) Notice: Content may be subject to change V1.2_102015

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