MEASURE THE DIFFERENCE · Monitors 2 2 2 1 2 2 2 1 2 2 Functional keyboard Automatic hemodynamic measurement Manual hemodynamic measurement Gradient calculation Uptime concept based

MEASURE THE DIFFERENCEFunctional diagnostics for electrophysiology and interventional cardiology

02

SMART.PRECISE.

RELIABLE.

MEASURE THE DIFFERENCE.

SCHWARZER CARDIOTEK has a long history in the development of diagnostics for cardiology. Today, our systems reflect the continuous cooperation of

cardiologists and scientists, combining state-of-the-art research and development to deliver the

smartest, most reliable and precise hardware and software solutions to our customers.

03SCHWARZER CARDIOTEK. SMART. PRECISE. RELIABLE.

“ 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.

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 workflow. ”_ Frank-Peter Klein

President & Chief Executive Officer

Schwarzer CardiotekMany years of experience and

comprehensive expertise in the field of modern

cardiology diagnosis.

60 +YEARS OF

EXPERIENCESINCE 1938

1,000 +HEMODYNAMIC

SYSTEMS INSTALLED

800 +ELECTROPHYSIO- LOGIC SYSTEMS

INSTALLED

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.

04MEASURE THE DIFFERENCE.

EXCELLENT SIGNAL QUALITYWe do not amplify the noise but the signal. The Schwarzer Cardiotek preamplifier technology offers brilliant signal quality.

Unique in the field of cardiology: the Schwarzer Cardiotek keyboard.

SYSTEM INTEGRATION AND SECURITYTaking 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.


HIGHEST QUALITY STANDARDSAssuring 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.

06

SMART.PRECISE.

RELIABLE.

MEASURE THE DIFFERENCE.

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 benefited from the company’s many years of experience and the high quality of the product. In pediatrics we find the precision of the equipment especially valuable.”

EXPERT’S OPINION


Heart Catheter Lab HIS

PACSDICOM Viewer

evo system

Stock

COM Server

Runs

File Transfer

Runs

Billing Report PDFMPPS

Worklist /DICOM-UID

Worklist

Patient Stay Doctors Appointment

ReportPDF

DICOM-UID

DICOM-UID

DICOM-UID

HEMODYNAMICS

evoSeries Precise recording, measurement and calculation

Perfect interactionClinical communication structures and Schwarzer Cardiotek evo system.

HL7Health Level 7

DICOMDigital Imaging and Communications in Medicine

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.


Prof. Josep BrugadaServei de Cardiologia,

Institut Clínic del Tòrax Hospital Clínic,

University of Barcelona

“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 benefits 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.”

EXPERT’S OPINION

The EP-TRACER 2 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 2 is available in several versions for both stationary and mobile systems. The ability to transfer data from all common ablators ensures consistent documentation of diagnosis and intervention.

* Reg.U.S.Pat.Off., EP-TRACER with new software version 2.2

ELECTROPHYSIOLOGY

EP-TRACER® 2*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

EP-TRACER 2 MobileCart

EP-TRACER Portable

EP-TRACER 2 Stationary


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.

COMBINED SOLUTIONS HEMO -EP

evoduoThe 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

EP-TRACER 2 102


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.

CARDIOLOGY INFORMATION SYSTEM

cardWorksThe 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

Versatile add-on modules Our diverse range of add-on modules supports the user to create the most efficient workflow. 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 findings)■ statistical analysis of procedural and patient-relevant data,

material use and staff productivity


cardWorks offers fully automated reporting along with a complete package of interfaces that provide a smooth, personalized workflow for each user.

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.

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.


evonatalFor pediatric cardiology

evosuperiorFor high-performance cardiology

evoprime+Comprehensive functionality with outstanding comfort

evoprimeComprehensive functionality in a compact package

evoduo natalCombined system, two-monitor version, also for pediatrics

evoduo superiorCombined system, two-monitor version, dual computing concept

evoduo primeCombined system, two-monitor version

EP-TRACER 2 PortablePortable EP recording system with built-in stimulator

EP-TRACER 2 MobileCart Mobile EP recording system with built-in stimulator

EP-TRACER 2 StationaryEP recording system with built-in stimulator

Blood pressure amplifier 4 4 4 4 4 4 4 3 3 3

Auxiliary channels (incl. invasive blood pressure)

6 6 6 6 6 6

EP-amplifier channels (EP-TRACER 38, 70 or 102) 38, 70, 102 38, 70, 102 38, 70 38, 70, 102 38, 70, 102 38, 70, 102

Bipolar intracardiac channels 20, 52, 84 20, 52, 84 20, 52 20, 52, 84 20, 52, 84 20, 52, 84

Integrated stimulator channels 2 2 2 2 2 2

Backup pacing

Monitors 2 2 2 1 2 2 2 1 2 2

Functional keyboard

Automatic hemodynamic measurement

Manual hemodynamic measurement

Gradient calculation

Uptime concept based on dual CPU utilization

Pediatric cardiology

Load stages control

HEMODYNAMICS

THE PERFECT SOLUTIONS FOR YOUR NEEDS


evonatalFor pediatric cardiology

evosuperiorFor high-performance cardiology

evoprime+Comprehensive functionality with outstanding comfort

evoprimeComprehensive functionality in a compact package

evoduo natalCombined system, two-monitor version, also for pediatrics

evoduo superiorCombined system, two-monitor version, dual computing concept

evoduo primeCombined system, two-monitor version

EP-TRACER 2 PortablePortable EP recording system with built-in stimulator

EP-TRACER 2 MobileCart Mobile EP recording system with built-in stimulator

EP-TRACER 2 StationaryEP recording system with built-in stimulator

Blood pressure amplifier 4 4 4 4 4 4 4 3 3 3

Auxiliary channels (incl. invasive blood pressure)

6 6 6 6 6 6

EP-amplifier channels (EP-TRACER 38, 70 or 102) 38, 70, 102 38, 70, 102 38, 70 38, 70, 102 38, 70, 102 38, 70, 102

Bipolar intracardiac channels 20, 52, 84 20, 52, 84 20, 52 20, 52, 84 20, 52, 84 20, 52, 84

Integrated stimulator channels 2 2 2 2 2 2

Backup pacing

Monitors 2 2 2 1 2 2 2 1 2 2

Functional keyboard

Automatic hemodynamic measurement

Manual hemodynamic measurement

Gradient calculation

Uptime concept based on dual CPU utilization

Pediatric cardiology

Load stages control

COMBINED SOLUTIONS HEMO -EP ELECTROPHYSIOLOGY

THE PERFECT SOLUTIONS FOR YOUR NEEDS


EASI LEAD SYSTEMSingle use electrodesIn 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 firmly 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.

MULTI-PARAMETER MODULE FOR PATIENT MONITORINGPhilips IntelliVue X2 Multi-Parameter ModuleThe 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 configurable). 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■ CO2 measurement in the main or side stream

FRACTIONAL FLOW RESERVEEvaluation without additional monitors and systemsThe 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-amplifier, 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.

ADDITIONAL PRODUCTS For improved diagnostics


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 SupportProviding 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.

TrainingsTraining 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 www.schwarzercardiotek.com

Schwarzer Cardiotek GmbHIm Zukunftspark 374076 HeilbronnGermanyPhone +49 (0)7131 2774 500 Fax +49 (0)7131 2774 590 [email protected]

CardioTek B.V.Amerikalaan 70 6199 AE Maastricht-Airport The NetherlandsPhone +31(0) 43 365 60 06Fax +31(0) 43 365 60 07

Hotline: +49 (0)7131 2774 555 www.schwarzercardiotek.com

Not

ice:

Con

tent

may

be

subj

ect t

o ch

ange

· V

3_0_

03_2

017

Documents

MEASURE THE DIFFERENCE · Monitors 2 2 2 1 2 2 2 1 2 2 Functional keyboard Automatic hemodynamic measurement Manual hemodynamic measurement Gradient calculation Uptime concept based