Physiologic Monitoring Systems, Cardiac Electrophysiology

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail [email protected]

UMDNS Information

This Product Comparison covers the following device term and product code as listed in ECRI Institutes Universal Medical Device Nomenclature System (UMDNS):

Monitoring Systems, Physiologic, Cardiac Electrophysiology [17-898]

Physiologic Monitoring Systems, Cardiac Electrophysiology

Scope of this Product Comparison

This Product Comparison covers physiologic monitoring and recording systems used for cardiac

electrophysiology studies (EPSs) and associated therapies. Included are dedicated units, as well as cardiac

catheterization physiologic monitoring systems that have EPS capabilities. For information on other physiologic

monitoring systems, see the following Product Comparisons:

Physiologic Monitoring Systems, Acute Care; Neonatal;

ECG Monitors; Monitors, Central Station

Physiologic Monitoring Systems, Cardiac Catheterization

Physiologic Monitoring Systems, Stress Exercise, Cardiac;

Pulmonary

Physiologic Monitoring Systems, Telemetric; ECG

Monitors, Telemetric; Monitors, Central Station

These devices are also called: cardiac electrophysiology

monitoring systems, cardiac monitors, electrocardiographic

monitors, operating room monitors, and OR monitors.

Purpose

Cardiac EPSs are used, in conjunction with cardiac

catheterization, for patients with arrhythmia or conduction

disorders. During an EPS, several diagnostic tests and therapeutic treatments are performed, including analysis

of the function of various components of the atrioventricular (AV) conduction system under certain stressors,

determination of the site of interventions, and assessment of sinus node function. EPSs also include induction and

termination of ventricular tachycardias by means of an electrical stimulator in a controlled setting for diagnostic

purposes or to evaluate responses to antiarrhythmia drug therapies. Other tests currently performed in EPS

laboratories include evaluation of automatic implantable cardioverter-defibrillators (AICDs) to ensure proper

functioning and tilt tests to diagnose presyncope.

EPSs are indicated for patients with sinus node dysfunction, AV block, and supraventricular and ventricular

tachycardias. They are also performed on patients undergoing

pharmacologic, electrical, or ablative treatment of arrhythmias;

survivors of cardiac arrest; and patients with Wolff-Parkinson-White

syndrome (anomalous AV excitation), unexplained syncope, or

heart palpitations.

Patients being considered for AICDs undergo EPSs before

implantation to determine, among other things, the cause of the

arrhythmia, the optimal site for shock delivery (i.e., lead placement),


2 2009 ECRI Institute. All Rights Reserved.

and the most effective sequence of stimulation to achieve normal cardiac rhythm. (For more information, see the

Product Comparison titled Pacemakers, Cardiac, Implantable; Resynchronization.)

Principles of operation

EPSs are typically performed in cardiac

catheterization laboratories (cath labs) or dedicated

fluoroscopy suites. Before an EPS can be

performed, the patient must first undergo cardiac

catheterization, which allows endocardial catheter

electrodes capable of both electrical stimulation

and recording to be guided into the heart intra-

arterially or intravenously using fluoroscopy. (For

a detailed discussion of cardiac catheterization, see

the Product Comparisons titled Physiologic

Monitoring Systems, Cardiac Catheterization and

Radiographic/Fluoroscopic Systems,

Angiographic/Interventional; Cardiovascular.)

Before catheterization, a diagnostic 12-lead electrocardiogram (ECG) is usually performed to obtain baseline

values. This preliminary study can also disclose unsuspected abnormalities.

During catheterization, the electrophysiology (EP) monitoring/recording system amplifies, conditions, and

records signals obtained from the intracardiac electrodes as well as signals from surface electrodes and blood

pressure transducers. These monitoring systems also aid in the placement of catheters and help the physician

observe any changes resulting from treatment during catheterization.

A basic EP monitoring and recording system consists of a horizontal or vertical console with a monitor, a chart

recorder to print data and waveforms, a data recording system (e.g., magnetic or optical disk), and plug-in

modules to perform various amplification and conditioning functions. The recorder should be able to record 4 to

32 ECG signals, and the recording amplifiers should have high- and low-frequency filters for recording signals

from either surface or intracardiac electrodes. The recorder should also be able to respond to frequencies of up to

500 Hz. Most systems have between 6 and 38 channels (some may have up to 192 channels) and input switching

systems for selecting various combinations of electrodes. Waveforms are displayed on the screen and are

recorded correspondingly; most systems allow waveforms to be frozen on the monitors screen. Some can show

test protocols, results, and calculations on a separate video display unit, while others can annotate the chart

printouts, which can also feature a variety of reference lines, such as grids and event markers. Additional

workstations are available for analysis and manipulation of data and waveforms for data management purposes.

Final reports can be generated at the workstation, and waveforms and data can be stored on digital media (e.g.,

magnetic tape, optical disk).

The number of intracardiac electrodes used for EPSs varies. Generally, two to four catheters are used; the

number is determined by the complexity of the study being performed. Points of placement include high in the

right atrium, in the region of the sinus node; at the AV junction; in the apex of the right ventricle; across the

tricuspid valve ring to record His bundle activity; and in the coronary sinus. To perform tricuspid valve analysis,

the electrode at the catheter tip is drawn through the valve to detect a signal change. Catheters commonly

measure from 4 to 8 French (Fr), and each catheter can have from two to eight electrodes with interelectrode

distances of 1 to 10 mm. Externally, three to six leads may be used. During an open-chest procedure, the surgeon

may also touch the myocardium with a wand-like device that has electrodes at the tip.

Electrical stimulation is performed with a programmable electrical stimulator that has an isolated output. (EP

monitoring and recording systems may not include stimulators, which would need to be purchased from a

stimulator supplier.) Stimulation is introduced during sinus rhythm or atrial or ventricular pacingfor instance,


2009 ECRI Institute. All Rights Reserved 3

to induce ventricular tachycardias, the characteristics of which can guide AICD programming or reveal the

patients response to antiarrhythmic or other drugs. The stimulator must be able to deliver at least two precisely

timed impulses during spontaneous and paced rhythms with cycle lengths of 150 to 1,500 msec, as well as

multiple extra stimuli from two or more sites simultaneously. It is also advisable for the stimulator to have a

safety switch to prevent pacing at



Reported problems

Most problems associated with electrophysiologic monitoring and recording involve inserting, advancing, and

maintaining the position of the catheter. These problems include hematomas, infection, vascular damage,

thrombosis, mechanically induced electrical irritation and arrhythmias, catheter clotting, and balloon rupture.

Other common problems are poor electrode preparation and placement.

The hazard of electric shock to patients must be considered in any room where electrical equipment is used

particularly in settings where a catheter provides a direct pathway for current to travel to the conduction system

of the heart. A safe power-distribution system and its associated grounding are essential, as are isolated electrical

inputs on all equipment that may come in contact with the patient (along with periodic inspection and

measurement of interequipment leakage currents). In the United States, the electrical wiring and fittings must be

installed in accordance with the U.S. National Electrical Code and standards for safe use of electricity in

healthcare facilities.

Damaged muscle tissue interferes with and slows the ventricular depolarization wave, causing reentrant

currents, which may trigger sustained ventricular tachycardia. This condition can degenerate into ventricular

fibrillation or death.

Purchase considerations

ECRI Institute recommendations

Included in the accompanying comparison chart are ECRI Institutes recommendations for minimum

performance requirements for cardiac EP systems.

EP systems may be mobile (e.g., cart mounted), tabletop, or wall mounted. The maximum channels (i.e., the

maximum number of modules that can be plugged into the unit and operated at one time) should be selected by

the physician based on procedural requirements. The system should have at least 12 surface electrocardiogram

(SECG) channels and 24 intracardiac electrocardiogram (IECG) channels, as well as programmed lead switching.

The EP lab monitoring and recording systems should have a console with high-resolution color monitors

suitable for display of waveforms and data; an integrated computer with data-processing software and recording

media (e.g., DVD, optical disk); a chart recorder with printing capabilities; plug-in modules that acquire vital

signs and procedure monitoring functions; and a remote amplifier unit to process and condition cardiac electrode

signals.

The EP system should be able to annotate chart printouts using a variety of reference lines (e.g., grids, event

markers), be able to interface with RF-generating devices and cardiac cath lab imaging systems, and have

multitasking software with user-configurable parameters that allows real-time signal analysis.

The EP lab system should be capable of networking and interfacing with a hospital information system; such

networking should be bidirectional and Health Level 7 (HL7) compliant. The EP lab system should also have the

ability to interface with a national cardiology database (e.g., American College of Cardiology/National

Cardiovascular Data Registry [ACC/NCDR]) and cardiology data management system.

Other considerations

Cardiac EP systems are typically customized to meet the facilitys needs. A basic system is configured with

amplifiers and filters for signal acquisition and processing, a display screen, and a recorder. It is possible to use

preexisting amplifiers and interface them with a corresponding display screen and recorder.

Clinicians should determine the maximum number of ECG channels desired; the number of available ECG

channels varies among systems. Varying sweep speeds up to 100 mm/sec must be available when performing

EPSs. Display screens vary in the number of waveforms that are displayed; correspondingly, the recorders vary



in the number of traces recorded. Some EP systems do not offer recorders as standard equipment because all the

waveforms can be retrieved from storage and viewed onscreen for manipulation. However, if a recorder is

required, it can be interfaced with these systems. Semiautomated or automated input switching systems allow for

the selection of various electrode combinations. Some systems allow the addition of amplifiers as needed.

Monitors used during EPSs are modular, allowing additional capabilities to be added later as the needs of the

lab change. In addition, although each manufacturers system is configured differently, most allow some

flexibility in adapting their configurations to the particular needs of the hospital. Therefore, in choosing a system,

it is important that the hospital consider its present and future needs, space limitations, and patient volume.

The number of channels provided by the recording system should correspond to the institutions applications.

Current systems vary in the type of recorder used (i.e., thermal, fiberoptic, ink-jet, or laser).

Data communications and data storage capabilities vary among systems. Communications capabilities can

provide links to other EP labs, central workstations, personal computers, or hospital data management systems.

Storage capabilities include various hard disk capacities and can also include a variety of digital media for

archival purposes and easy retrieval of data. Hospitals should consider their communications and storage needs

before making a purchase decision. EP monitoring and recording systems also come with a variety of analysis

and data management software packages, which allow user-programmable or customized report generation.

Stimulators are not offered as standard components by most EP monitoring and recording system

manufacturers and must be purchased from a stimulator supplier. This must be factored into the cost of the EP

system.

Facilities should also consider whether they require separate rooms for EPSs only or catheterization/EPSs.

When planning, the time required for each test, type and number of tests, and patient volume should be

considered. Some cardiac cath lab monitoring systems are also used for EPSs. For more information on equipment

planning, facilities should contact ECRI Institutes Applied Solutions Group (ASG).

Cost containment

Because EP is a dynamic technology, manufacturers frequently make software changes to enhance

performance or to meet current clinical needs; therefore, facilities should negotiate for software upgrades and

enhancements for no cost for the life of the equipment. Service contract costs should be specified in all purchase

contracts; they are usually negotiable. If a hospitals clinical engineering department plans to service the

equipment after the warranty period, the cost of service training should be included in the purchase contract, and

the hospital should negotiate for an inventory of frequently needed parts to be placed in the facility on

consignment. All clinical training should be included at no charge.

A life-cycle cost (LCC) analysis can be used to compare high-cost alternatives and/or to determine the positive

or negative economic value of a single alternative. For example, hospitals can use LCC analysis techniques to

examine the cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright.

Because it examines the cash-flow impact of initial acquisition costs and operating costs over a period of time,

LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs

of equipment ownership. One LCC techniquepresent value (PV) analysisis especially useful because it

accounts for inflation and for the time value of money (i.e., money received today is worth more than money

received at a later date). Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes

more than just the initial acquisition cost and that a small increase in initial acquisition cost may produce

significant savings in operating costs. The PV is calculated using the annual cash flow, the dollar discount factor,

and the lifetime of the equipment (in years) in a mathematical equation.



The following represents a sample seven-year PV/LCC analysis for an EP system.

Present Value/Life-Cycle Cost Analysis

Assumptions

Dollar discount factor is 6%

Inflation rate is 6% for a full-service contract

Service contract is based on 7% of the purchase price

Capital costs

Basic system = $105,000

Additional slave monitor = $4,000

Fluoroscopy image storage = $10,000

Total Capital Costs = $119,000

Operating costs

Service contract, years 2 through 7 = $8,330/year

Total Operating Costs = $0 in year 1; $8,330/year for years 2 through 7

PV = ($168,980)

As illustrated by the above sample PV/LCC analysis, the initial acquisition cost is only a fraction of the total

cost of operation over seven years. Therefore, before making a purchase decision based solely on the acquisition

cost, buyers should consider operating costs over the lifetime of the equipment.

Other costs not included in the above analysis, but important to consider before making a final purchasing

decision, include the costs of purchasing and operating EP imaging equipment. The fluoroscopic imaging system

used during the catheterization procedure should be, at minimum, a single-plane configuration with either a

tilting table or a C-arm. A biplane configuration is preferable and is often necessary for larger patients.

Maintenance costs for the imaging equipment (e.g., x-ray tube replacement) must also be considered.

EPSs can be performed in a cardiac cath lab, a dedicated or mobile fluoroscopy suite, or a dedicated EP

laboratory. Because an EPS can take three to six hours or more, hospitals should analyze an EP laboratorys

impact on existing cardiac catheterization or fluoroscopy services. Scheduling problems in cath labs may result

due to increasing numbers of EPSs being performed. As a result, hospitals may consider upgrading or adding a

new lab facility dedicated to EPSs. Installing a dedicated EP lab can cost between $300,000 and $500,000, while a

new cath lab will cost twice that. Depending on laboratory setup and utilization issues, hospitals must choose

between a dedicated EP system or a cath lab system with an EP option.

For further information on PV/LCC analysis, customized analyses, and purchase decision support, readers

should contact ECRI Institutes SELECTplus Group.

Stage of development

Since the late 1960s, cardiac EPSs have come into wide clinical acceptance for evaluating cardiac arrhythmias.

Over time, there has been increased computerization of the cath labs in which EPSs are typically performed. This

enables automated calculations and storage of waveforms and data on digital media.

Bibliography

Bevilacqua LM, Berul CL. Advances in pediatric electrophysiology. Curr Opin Pediatr 2004 Oct;16(5):494-9.

Darling EJ. Overview of cardiac electrophysiologic testing. Crit Care Nurs Clin North Am 1994 Mar;6(1):1-13.



Determinants of predicted efficacy of antiarrhythmic drugs in the electrophysiologic study versus

electrocardiographic monitoring trial. The ESVEM investigators. Circulation 1993 Feb;87(3):323-9.

Jalife J. Basic cardiac electrophysiology for the clinician. 2nd ed. Hoboken (NJ):Wiley-Blackwell; 2009.

Mason JW. A comparison of electrophysiologic testing with Holter monitoring to predict antiarrhythmic-drug

efficacy for ventricular tachyarrhythmias. N Engl J Med 1993 Aug 12;329(7):445-51.

Scheinman MM, Keung E. The year in review of clinical cardiac electrophysiology. J Am Coll Cardiol 2008 May

27;51(21):2075-81.

Strong growth in EP boosts cardiac rhythm market. Clinica 1996 Feb 5;691:16.

Ward DE, Camm AJ. Dangerous ventricular arrhythmiascan we predict drug efficacy? [letter]. N Engl J Med

1993 Aug 12;329(7):498-9.

Willems S, Weiss C, Ventura R, et al. Catheter ablation of atrial flutter guided by electroanatomic mapping

(CARTO): a randomized comparison to the conventional approach. J Cardiovasc Electrophysiol 2000

Nov;11(11):1223-30.

Zickler P. Electrophysiology. Med Imaging 1995 Jul;10(7):44-51.

Supplier information

BARD

Angiomed GmbH & Co Medizintechnik KG Sub C R Bard Inc [332055]

Wachhausstrasse 6

Karlsruhe D-76227

Germany

Phone: 49 (721) 94450 Fax: 49 (721) 9445111

Internet: http://www.crbard.com

E-mail: [email protected]

Bard China Sub C R Bard Inc [343164]

Swissotel Beijing Hong Kong Macau Center Dongsishitiao

Beijing 100027

People's Republic of China

Phone: 86 (10) 65014225

Bard Electrophysiology Div CR Bard Inc [435644]

55 Technology Dr

Lowell, MA 01851

Phone: (978) 441-6202, (800) 824-8724 Fax: (978) 323-2260

Internet: http://www.bardep.com

Bard Nederland bv Sub C R Bard Inc [343215]

Weverstedehof 10

Nieuwegein NL-3430 BD

The Netherlands

Phone: 31 (30) 6000570 Fax: 31 (30) 6022443

Internet: http://www.crbard.com




GALIX

Galix Biomedical Instrumentation Inc [176265]

2555 Collins Ave Suite C-5

Miami Beach, FL 33140

Phone: (305) 534-5905 Fax: (305) 534-8222

Internet: http://www.galix-gbi.com


GE HEALTHCARE

GE Healthcare Asia (Japan) [300443]

4-7-127 Asahigaoka Hino-shi

Tokyo 191-8503

Japan

Phone: 81 (3) 425826820 Fax: 81 (3) 425826830

Internet: http://japan.gehealthcare.com/cwcjapan


GE Healthcare France [171319]

11 avenue Morane Saulnier

Velizy Cedex F-78457

France

Phone: 33 (6) 07453493 Fax: 33 (1) 34495202

Internet: http://www.gehealthcare.com


GE Healthcare Technologies Diagnostic Cardiology [441472]

8200 W Tower Ave PO Box 414

Milwaukee, WI 53223-3219

Phone: (414) 355-5000, (800) 643-6439 Fax: (414) 355-3790

Internet: http://www.gehealthcare.com

GE Healthcare UK Ltd [401906]

Amersham Place

Little Chalfont HP 94SP

England

Phone: 44 (870) 6061920 Fax: 44 (1494) 544350

Internet: http://www.gehealthcareeurope.com

MENNEN MEDICAL

Mennen Medical Corp [101498]

950 Industrial Blvd

Southampton, PA 18966

Phone: (215) 259-1020, (800) 223-2201 Fax: (215) 675-6212

Internet: http://www.mennenmedical.com


Mennen Medical Ltd [171234]

4 Ha-Yarden Street PO Box 102

Rehovot IL-76100

Israel

Phone: 972 (8) 9323333 Fax: 972 (8) 9328510

Internet: http://www.mennenmedical.com




SIEMENS MEDICAL

Siemens Canada Ltd [174735]

2185 Derry Rd W

Mississauga, ON L5N 7A6

Canada

Phone: (905) 819-8000, (888) 303-3353 Fax: (905) 819-5777

Internet: http://www.siemens.ca


Siemens Medical Solutions USA Inc Health Service Corp [399199]

51 Valley Stream Pkwy

Malvern, PA 19355

Phone: (610) 219-6300, (888) 826-9702 Fax: (610) 219-3124

Internet: http://www.siemensmedical.com


Siemens SA de CV [339105]

Poniente 116 No 590

Cd de Mexico 02300

Mexico

Phone: 52 (5) 3282000 Fax: 52 (5) 3282017

Internet: http://www.siemens.com.mx


ST JUDE MEDICAL

St Jude Medical UK Ltd [301608]

Stratfrod Business & Technology Parl Banbury Road

Stratford upon Avon CV37 7GY

England

Phone: 44 (1789) 207600 Fax: 44 (1789) 207601

Internet: http://www.sjm.com


St Jude Medical Japan KK [382507]

F-Nisei Ebisu Building 6/Fl 3-16-3 Higashi Shibuya-ku

Tokyo 150-0011

Japan

Phone: 81 (3) 57780702 Fax: 81 (3) 57780704



St Jude Medical Inc Cardiology/Atrial Fibrillation Div [452237]

14901 DeVeau Pl

Minnetonka, MN 55345-2126

Phone: (952) 933-4700, (800) 328-3873 Fax: (952) 933-0307



TEB

TEB (Tecnologia Eletronica Brasileira Ltda) [174429]

Avenida Diederichsen 1057-1059 Vila Guarani

Sao Paulo-SP 04310-000

Brazil



Phone: 55 (11) 50178555 Fax: 55 (11) 50176472

Internet: http://www.teb.com.br


Note: The data in the charts derive from suppliers specifications and have not been verified through

independent testing by ECRI Institute or any other agency. Because test methods vary, different products

specifications are not always comparable. Moreover, products and specifications are subject to frequent changes.

ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse

consequences of acting on such information.

When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier

discounts. And although we try to indicate which features and characteristics are standard and which are not,

some may be optional, at additional cost.

For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the

conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change

often.

Need to know more?

For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610)

825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail).

Last updated June 2009



Policy Statement

The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization.

HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and

therapeutic capital equipment more effectively in support of improved patient care.

The information in Product Comparisons comes from a number of sources: medical and biomedical

engineering literature, correspondence and discussion with manufacturers and distributors, specifications from

product literature, and ECRI Institutes Problem Reporting System. While these data are reviewed by qualified

health professionals, they have not been tested by ECRI Institutes clinical and engineering personnel and are

largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the

quality or validity of information derived from outside sources or for any adverse consequences of acting on such

information.

The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison

System does not constitute the endorsement or approval of the products quality, performance, or value, or of

claims made for it by the manufacturer. The information and photographs published in Product Comparisons

appear at no charge to manufacturers.

Many of the words or model descriptions appearing in the Healthcare Product Comparison System are

proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any

name without designation as proprietary should not be regarded as a representation that is not the subject of

proprietary rights.

ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare

Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI

Institute and its employees accept no royalties, gifts, finders fees, or commissions from the medical device

industry, nor do they own stock in medical device companies. Employees engage in no private consulting work

for the medical device industry.

About ECRI Institute

ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research

in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for over 40

years, ECRI Institute marries experience and independence with the objectivity of evidence-based research.

More than 5,000 healthcare organizations worldwide rely on ECRI Institutes expertise in patient safety

improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology.

ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World

Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and

Quality. For more information, visit http://www.ecri.org.



Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1

BARD GALIX GE HEALTHCARE

Basic EP Systems LabSystem Pro PHYSIO-28 CardioLab IT

WHERE MARKETED Worldwide Asia, Latin America Worldwide

FDA CLEARANCE Yes No Yes

CE MARK (MDD) Yes No Yes

CONFIGURATION Mobile (e.g., cart mounted), tabletop, wall mount

Cart mounted, horizontal, portable

PC-based software, fixed desk, mobile cart

Stationary, mobile

MAXIMUM CHANNELS By user requirements 16-80 16 IECG, 12 SECG Up to 128 with 224 inputs, 12-lead ECG, SpO2, up to 4 IBP, NIBP, TDCO, optional ETCO2, analog output synchronization

PLUG-IN MODULES SECG, IBP, device interface(s), IECG; others as required

SECG plus 2 IBP, V lead plus 2 IBP, IECG, STIM interface for cardiac stimulator, HLII1

Integrated 12-lead ECG, 16 HIS ECG, built-in multiprogrammable stimulator

CLab II plus amplifier, TRAM 451, ETCO2

SECG CHANNELS 12 12 12 Up to 12

IECG CHANNELS 24 Up to 72, 144 inputs 16 Up to 224

STIMULATORS INCLUDED

Optional No Yes Optional MicroPace

PROGRAMMED LEAD SWITCHING

Yes Yes Yes Yes

DISPLAY SCREEN Yes Type High-resolution, 16 colors

(1280 x 1024) High-resolution SVGA color LCD

Two or three 20" flat-panel, 1600 x 1200 resolution

Diag size, cm (in) 50.8 (20) 43.2 (17), 48.3 (19), 53.3 (21)

50.8 (20)

Data displayed Not specified Not specified Not specified User selectable Number of traces 32, user-configurable Up to 80 simultaneously 16 64/page Sweep speeds, mm/sec 5, must be user-selectable 25, 50, 100, 200, 400, 800 25, 50, 100, 200, 400, 800 5, 10, 25, 50, 100, 200, 400,

user-entered value

This is the first of five pages covering the above model(s). These specifications continue onto the next four pages.







RECORDER Type Thermal array, laser printer High-resolution laser Any Windows-compatible

laser printer NA (optional laser printer)

Number of traces 12, user-configurable 80 16 Laser printer, based on screen layout

Paper speed, mm/sec 5, 12.5, 25, 50; variable Not specified 25, 50, 100, 200, 400, 800 NA Annotations Name, ID, date, time;

clinical values as required Yes Name, operator, date/time,

speed, ECG grid, position, comments

Name, ID, paper speed, ECG and waveform grids, text header, date/time, free drawing

Line selections Timing, millimeter grid/ruler Grid for amplitude and timing reference measurements, 12-lead ECG available on demand to print

Amplitude and time grids Laser printer, based on screen layout

INTEGRAL COMPUTER Any IBM Pentium Best available PC 2.33 GHz dual-core Xeon, Windows XP SP2 operating system

Applications Not specified Not specified Not specified Data management Yes Yes Yes Yes Statistical analysis Yes See Other Specifications No Yes, Centricity CVIS Report generator Yes Yes Microsoft Word-based MS Word-based Other None specified None specified Orders, scheduling, ADT,

charge capture, physician reporting, Holter, macros

Storage Not specified (DVD) 500 GB hard drive, CD-R/DVD long-term

Dual 80 GB HDD, 9.4 GB DVD/RAM, 144-900 GB RAID server

NETWORKING BETWEEN LABS

Yes No Windows Yes

INTERFACES Biosense Webster's CARTO XP, ablation generators and stimulators

HIS Yes Optional No Optional (ADT, orders, billing/charge capture, material management, results)

Suppliers Not specified NA Optional

This is the second of five pages covering the above model(s). These specifications continue onto the next three pages.







Cardiology data management system

Yes Optional No Integrated with GE Centricity Cardiology CVIS, optional interface to third-party CVIS

Suppliers Not specified NA Optional Cath lab imaging system Not specified Not specified Not specified Optional, GE and third party

via DICOM National Cardiology Database

Not specified Not specified Not specified GE and third party

This is the third of five pages covering the above model(s). These specifications continue onto the next two pages.







POWER REQUIREMENTS VAC, Hz 100/120/220/240, 50/60 110/220, 50/60 Hz 100-240, 50/60 Hz Consumption, W Not specified 500 1,800 maximum

H x W x D, cm (in) 86.3 x 74 x 160 (34 x 29 x 63)

9.6 x 30.2 x 27.2 (3.8 x 11.9 x 10.7), console without PC

82.5 x 81 x 76 (32.5 x 32.1 x 30)

WEIGHT, kg (lb) 272 (600) 2 (4.4) without PC 113 (249.2)

PURCHASE INFORMATION

Price range $50,000-150,000 $16,000-25,000 Not specified Warranty 1 year, parts, service, and

installation 18 months, parts and labor 1 year, parts and labor

Delivery time, ARO 2-4 weeks 4 weeks 45 days Service contract ~8% of purchase price Yes Optional Year first sold 2003 1998 2003, 2000 (CardioLab

2000, 4000, and 7000), 1989 (DOS-based)

Number installed USA Not specified Not specified >1,000 (combined IT

platform) Worldwide Not specified Not specified >1,500

Fiscal year January to December April to March January to December

GREEN FEATURES None specified None specified None specified

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.







OTHER SPECIFICATIONS Windows 2000 operating system; customizable user interface; modular STAMP amplifier; template matching; T-wave subtraction; waveform analysis; data centralization (stimulator, RF generator, imaging); MS Word reports; DVD archiving; MicroPace stimulator interface; optional image capture.

Programmable and preconfigured protocols; selection of stimulation channel by software; real-time and capture screens; triggering by any channel and stimulus synchronization; automatic rate measurement; amplitude and time measurement with unlimited number of calipers; event markers; storage of long-term studies; multiprogrammable stimulator with up to 3 extrastimuli; 3 methods of tachycardia termination; backup pacing and capability to work with independent automatic increment/decrement of coupling extrastimuli intervals.

EP-only application; 3-D mapping interface option with Biosense Webster CARTO XP system; bidirectional interface; auto storage of mapping points; transfer of color snapshot and comprehensive report generation; auto control of CardioLab from CARTO XP system; CardioImage fluoroscopy image management system with up to 4 inputs of imaging; live and frozen snapshots display; centralized waveform archive with near real-time review of raw waveforms from any office PC connected to server; custom forms; interactive statistic, user-defined macros to automate tasks; full-disclosure storage of waveforms; remote modem support; dual hemo/EP capabilities; Nellcor OxySmart or Masimo SpO2; interactive administrative reporting; inventory management; billing/charge capture; online structured physician reporting.

UMDNS CODE(S) 17898 17898 17898 17898

LAST UPDATED May 2005 June 2009 June 2008

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

Model Footnotes

Data Footnotes




MODEL GE HEALTHCARE MENNEN MEDICAL SIEMENS MEDICAL ST JUDE MEDICAL1 ComboLab IT EMS-XL 32/64 AXIOM Sensis XP EP

System1 EP WorkMate Recording System

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes

CONFIGURATION Stationary, mobile PC-based software, movable console, mobile cart, combo with Horizon SE

Cabinet, table Cart or permanent install, 2 primary monitors, slave monitors, 120 or 56 catheter inputs

MAXIMUM CHANNELS Up to 128 with 224 inputs, 12-lead ECG, SpO2, up to 4 IBP, NIBP, TDCO, optional ETCO2, analog output synchronization

32 or 64, 12 SECG, 2 IBP, 18/50 IECG

128 448 stored from up to 140 total inputs

PLUG-IN MODULES CLab II plus amplifier, TRAM 451, ETCO2

Integrated 12-lead ECG, 18/50 IECG, dual output multiprogrammable stimulator

Inputs available in integrated input box and Hemopod (12-channel ECG, HR, cycle length, 4 IBP, thermal dilution CO, SpO2, NIBP, 1 QRS sync, respiration/CO2 module)

Up to 4 pressure-monitoring channels, multimodality image acquisition, remote nurses charting station, navigation interfaces, FFT analysis

SECG CHANNELS Up to 12 12 12 12

IECG CHANNELS Up to 224 18/50 0, 32 (not available in USA), 64, or 128

56, 120


Optional MicroPace Dual-output multiprogrammable

Stimulator interface Yes


Yes Yes Yes Yes

DISPLAY SCREEN Type Two or three 20" flat-panel,

1600 x 1200 resolution 2 high-resolution SVGA LCD flat-panel color

21" (1600 x 1200) flat-panel color (EP and combo unit)

High-resolution LCD flat-panel

Diag size, cm (in) 50.8 (20) 50.8 (20) 53.3 (21), Sensis XP configuration dependent

53.3 (21)

Data displayed User selectable HR, systolic, diastolic, mean pressure

User-configurable data parameters, including 12-lead ECG, 4 IBP, NIBP, SpO2, respiration, HR, cycle length, ablation data

SECG, IECG pressure tracings, heart rate, ablation parameters

Number of traces 64/page 2 panels, 32 traces each Unlimited, user configured, theoretical end at 80 traces

32/page, 6 pages

Sweep speeds, mm/sec 5, 10, 20, 25, 50, 100, 200, 400, user-entered value

25, 50, 100, 150, 200, 300 12.5, 25, 50, 100, 200, 400 (real-time and review mode)

10-600







RECORDER Type NA (optional laser printer) Any network laser printer Laser printer

(network/parallel port) LaserJet

Number of traces Laser printer, based on screen layout

32 Unlimited, user configured 64

Paper speed, mm/sec NA 25, 50, 100, 150, 200, 250, 300

12.5-400 real-time mode 10-300

Annotations Name, ID, paper speed, ECG and waveform grids, text header, date/time, free drawing

Name, operator, date/time, speed, ECG grid, position, comments

Yes Annotations are user-configurable; text, characters, or numbers

Line selections Laser printer, based on screen layout

Amplitude and time grids Millimeter grid, raster is user configurable

Lines or grid format

INTEGRAL COMPUTER 2.33 GHz dual-core Xeon, Windows XP SP2 operating system

2.8 GHz Pentium 4 Pentium 4, 3.0 GHz Dual-core Xeon processors

Applications Not specified Not specified Microsoft XP Professional on ACQ and workstations, Microsoft Server 2003 on high-end server

Not specified

Data management Yes Optional Yes (with information system)

EP monitoring and stimulation

Statistical analysis Yes, Centricity CVIS Yes (with optional data management)

Yes (with information system)

No

Report generator MS Word-based MS Word-based MS Word-based online and offline

Yes

Other Orders, scheduling, ADT, charge capture, physician reporting, Holter, ST segment, macros

None specified Dedicated AXIOM Sensis server

None specified

Storage Dual 80 GB HDD, 9.4 GB DVD/RAM, 144-900 GB RAID server

80 GB hard drive, optional CD-R/DVD-RW

160 GB hard disk (RAID 5 available)

160 GB RAID redundant backup


Yes Windows 2000 Ethernet, TCP/IP, DICOM, HL7, open architecture

Optional

INTERFACES Biosense Webster's CARTO XP, ablation generators and stimulators

Not specified Not specified Biosense Webster CARTO system, Phillips Allura system, most approved ablation generators, HL7, LUMEDX, Xcelera

HIS Optional (ADT, orders, billing/charge capture, material management, results)

Optional DICOM, HL7, ASCII, bidirectional

Yes

Suppliers Optional Not specified; standard HL7 protocol for ADT, HL7 results or XML, RTF, and FTP

Proprietary Optional





MODEL GE HEALTHCARE MENNEN MEDICAL SIEMENS MEDICAL ST JUDE MEDICAL1 ComboLab IT EMS-XL 32/64 AXIOM Sensis XP EP System1 EP WorkMate Recording

System


Integrated with GE Centricity Cardiology CVIS, optional interface to third-party CVIS

Optional Yes Yes

Suppliers Optional Mennen Medical All Optional Cath lab imaging system

Optional, GE and third party via DICOM

Not specified Siemens proprietary Not specified

National Cardiology Database

GE and third party Not specified ACC-NCDR modules (data collected for submission to third party), Heartlab/LUMEDX/Apollo/AXIS/Goodroe

Not specified







POWER REQUIREMENTS VAC, Hz 100-240, 50/60 Hz 110/220, 50/60 Hz 100-120, 230-240, 50/60 Hz 85-265, 47-63 Consumption, W 1,800 maximum 400 1,200 VA maximum 1,500

H x W x D, cm (in) 82.5 x 81 x 76 (32.5 x 32.1 x 30)

74.5 x [80.5-96] x 82 (29.3 x [31.7-37.8] x 32.3) console with monitor; 103 x 60 x 60 (40.6 x 23.6 x 23.6) mobile cart

72 x 120 x 80 (28.3 x 47.2 x 31.5) with cabinet

183 x 121.9 x 91.4 (72 x 48 x 36)

WEIGHT, kg (lb) 113 (249.2) 80 (176) console without transformer, 50 (110) mobile cart without transformer, 29 (63.9) transformer

~85 (187.4), including monitors

272 (600)


Price range Not specified $66,750-82,000 Not specified $208,215-238,140 Warranty 1 year, parts and labor 1 year, parts and labor 1 year 1 year, parts and labor Delivery time, ARO 45 days 90 days FOB 6-8 weeks 30-60 days Service contract Optional Yes Optional 1-year increments, full

service and biomedical second call-in

Year first sold 2003, 2000 (ComboLab 2000 and 7000), 1989 (DOS-based)

2003 2003 1996

Number installed USA >1,000 (combined IT

platform) Not specified >700 700

Worldwide >1,500 Not specified >1,000 400 Fiscal year January to December January to December October to September January to December

GREEN FEATURES None specified None specified None specified None specified







OTHER SPECIFICATIONS EP-only application; 3-D mapping interface option with Biosense Webster CARTO XP system; bidirectional interface; auto storage of mapping points; transfer of color snapshot and comprehensive report generation; auto control of CardioLab from CARTO XP system; CardioImage fluoroscopy image management system with up to 4 inputs of imaging; live and frozen snapshots display; centralized waveform archive with near real-time review of raw waveforms from any office PC connected to server; custom forms; interactive statistic, user-defined macros to automate tasks; full-disclosure storage of waveforms; remote modem support; Nellcor OxySmart or Masimo SpO2; interactive administrative reporting; inventory management; billing/charge capture; online structured physician reporting.

12-lead ECG and IECG interface for third-party mapping systems; interface to RF ablation systems.

Multitasking, multiuser system; DICOM, HL7, ASCII communication optional. Meets requirements of CAN/CSA C22.2 No. 601-1M90; EN 865; IEC 60601-1, 60601-1-2, 60601-1-25, 60601-2-30, 60601-2-34, and 60601-2-49; and UL 2601-1.

None specified.

UMDNS CODE(S) 17898 17898 17898 17898

LAST UPDATED June 2008 June 2009 June 2009 June 2009

Supplier Footnotes 1St Jude Medical recently purchased EP MedSystems.

Model Footnotes 1Hemo, EP, and combo system.

Data Footnotes




MODEL TEB SP12/32

WHERE MARKETED Mexico, South America

FDA CLEARANCE No

CE MARK (MDD) No

CONFIGURATION Cart mounted

MAXIMUM CHANNELS 38

PLUG-IN MODULES None, all functions are integral; 12 SECG, 18 IECG, 4 IBP, 1 thermodilution, 4 external inputs, 3 outputs

SECG CHANNELS 12

IECG CHANNELS 18


Yes


Yes

DISPLAY SCREEN Type 2 high-resolution color LCDs Diag size, cm (in) 43 (17) Data displayed Not specified Number of traces 32 Sweep speeds, mm/sec 12.5, 25, 50, 100, 200, 300





MODEL TEB SP12/32

RECORDER Type Laser printer Number of traces 32 Paper speed, mm/sec 12.5, 25, 50, 200, 300, 400 Annotations Date, time, lead, patient ID,

gain, paper speed Line selections Time grid

INTEGRAL COMPUTER AMD SEMPROM 64 3200 Applications Not specified

Data management No Statistical analysis No Report generator Yes Other No

Storage 80 GB


No

INTERFACES HIS No

Suppliers NA





MODEL TEB SP12/32


No

Suppliers NA Cath lab imaging system Not specified National Cardiology Database

Not specified





MODEL TEB SP12/32

POWER REQUIREMENTS VAC, Hz 110/220, 50/60 Consumption, W 380

H x W x D, cm (in) 140 x 90 x 63 (55 x 35 x 25)

WEIGHT, kg (lb) 82 (180)


Price range $44,000 Warranty 1 year, parts and labor Delivery time, ARO 4-6 weeks Service contract No Year first sold 1994 Number installed

USA NA Worldwide 452

Fiscal year January to December

GREEN FEATURES None specified





MODEL TEB SP12/32

OTHER SPECIFICATIONS Continuous storage in hard disk; DVD recorder included to save stored data at end of procedure; USB port; Windows-based software included on PC. Registered by the Brazilian Ministry of Health. TEB is ISO 9001 and ISO 13485 certified; IEC 601 certified.

UMDNS CODE(S) 17898

LAST UPDATED June 2009

Supplier Footnotes

Model Footnotes

Data Footnotes

Scope of this Product ComparisonPurposePrinciples of operationSecurityExternal databases and registries

Reported problemsPurchase considerationsECRI Institute recommendationsOther considerationsCost containmentPresent Value/Life-Cycle Cost Analysis

Stage of developmentBibliographySupplier informationPolicy StatementAbout ECRI InstituteProduct Comparison Chart

Documents

Physiologic Monitoring Systems, Cardiac Electrophysiology