July 2002

Physiologic Monitoring Systems, Cardiac

Catheterization
Scope of this Product Comparison
This Product Comparison covers physiologic
monitoring/recording systems intended for use in
the cardiac catheterization laboratory (cath lab).
Related equipment, such as imaging systems,
cine projectors, catheters, and freestanding car-
diac output computers, is not included. For more
information on these topics, see the following
Product Comparisons:
The pressures in the various chambers of the heart and
great vessels are thereby determined. From this data,
it is possible to calculate systemic and pulmonary blood
flows, note the presence or absence of shunts and their
size, calculate cardiac output and the vascular resis-
tance in the lungs, determine the work done by the
heart, and determine valve area in patients with val-
vular stenosis. These monitoring systems are also used
to help place catheters and to help observe any changes
resulting from treatment during catheterization.

• Cardiac Output Units, Thermal Dilution Cardiac catheterization has traditionally been part
of a complete evaluation of a patient with known or
• Radiographic/Fluoroscopic Systems, Angio- suspected heart disease (most commonly coronary
graphic/Interventional; Cardiovascular

UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature System™
(UMDNS™):
• Physiologic Monitoring Systems, Cardiac
Catheterization [12-648]

Purpose
Cardiac catheterization is an invasive procedure
used primarily to locate and identify irregularities
within the heart and its vasculature, the aorta, or the
vena cava, as well as to define the size or severity of
lesions. During this procedure, the cath lab monitor-
ing/recording system amplifies, conditions, and re-
cords signals obtained from blood pressure
transducers and surface and intracardiac electrodes.

169860 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org
Healthcare Product Comparison System
artery disease), although it is also used in diagnosing
disorders such as reduced left ventricular function,
valve incompetence, pulmonary vascular disease, and
congenital anomalies. It is also used for pacemaker
lead placement. Also, some systems may include a
workstation for report preparation and review in a
separate location.
Principles of operation
The basic cath lab recording system consists of a
computer console and a chart recorder, which typically
reside in a control room. A slave scope and patient
interface modules reside in the cath lab. All the systems
are multichannel and display and record 8 to 38 traces
of information from the patient. Linking the cath lab
monitor/recorder with a computer allows most of the
hemodynamic parameters to be calculated automat-
ically. The parameters that are automatically derived
typically include cardiac output, pressure gradients,
valve areas, shunt flows, vascular resistance, diastolic
filling period, systolic ejection period, work, and pree-
jection period. These values are stored chronologically,
along with other important events occurring during
catheterization, and can be printed in report form at
the conclusion of the procedure. It is possible to inter-
face with the cath lab imaging system to provide x-ray
image visualization on the physiologic monitor.
Before catheterization, a full 12-lead electrocar-
diogram (ECG) is usually performed to obtain base-
line values. This preliminary study can also disclose
unsuspected abnormalities. During the procedure,
Jugular Vein
Superior
Vena Cava
Pulmonary Artery
Right Ventricle
Basilic Vein
Femoral Vein
C406UN3A
Figure 1. Right-heart catheterization (RHC)
2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Aortic Arch
Left Ventricle
Brachial Artery
C406UN3B
Femoral Artery
Figure 2. Left-heart catheterization (LHC)
continuous arterial pressure can be monitored di-
rectly.
For right-heart catheterization (RHC), the catheter
is introduced into a vein in the arm, the external jugular
vein, or the femoral vein in the groin and then manipu-
lated into the right atrium of the heart under direct
observation using fluoroscopy. The catheter is then
passed through the right ventricle and lodged in the
pulmonary artery (see Fig. 1). In left-heart catheteri-
zation, which is less common, the catheter is introduced
into an artery in the arm or into the femoral artery and
maneuvered through the aortic valve and into the left
ventricle (see Fig. 2). Although RHC is the most com-
mon type of catheterization, there has been recent
debate about its benefits and risks. RHC has been
believed to be of great benefit to the patient, but a recent
study suggests that patients who undergo RHC have
higher mortality rates than comparably ill patients who
do not undergo the procedure (Connors et al. 1996). The
resolution of this issue is not currently apparent.
Pressure measurements from the pulmonary artery,
including pulmonary artery wedge pressure, provide
one reliable index of left-ventricular function. Pressure
gradient recordings can be made by drawing the cathe-
ter back through the chambers of the heart; gradients
from one chamber to another indicate the site of
stenosis or obstruction. Pressure measurements taken
in the right atrium determine central venous pressure.
Intracardiac pressure measurements are taken by
one of two methods. The more common method uses a
 Physiologic Monitoring Systems, Cardiac Catheterization
fluid-filled catheter and a blood pressure transducer.
The fluid-filled lumen of the catheter transfers pres-
sure fluctuations from the open distal end of the cathe-
ter inside the patient to a transducer at the proximal
end outside the patient, which converts the mechanical
force of the applied pressure into electrical signals that
are proportional to that pressure. These signals are
then transmitted to a pressure amplifier in the record-
ing system. The second, less common method uses a
transducer in the catheter tip to measure pressure
fluctuations. Although they theoretically produce dis-
tortion-free tracings, catheter-tip transducers are
fragile, expensive, and difficult to calibrate in vivo.
The status of the myocardium can be evaluated by
measuring pulmonary and systemic blood flows to
determine cardiac output. The most widely used
method is the thermal dilution technique in which a
chilled or room-temperature saline solution is injected
through the catheter into the right atrium; its tem-
perature is measured by a thermistor at the distal end
of the catheter, located in the pulmonary artery. The
temperature change correlates with the blood flow
through the heart. In a less common method, the
dye-dilution technique, dye is injected into the circula-
tory system at one point, and blood is sampled down-
stream until the dye appears. Changes in the
concentration of dye passing through the heart indi-
cate cardiac output.
The original method of determining cardiac output
was the Fick principle, which is accurate but more
time-consuming than other methods. Blood samples
are drawn through the catheter from the right and left
sides of the heart to obtain oxygen saturation meas-
urements, while simultaneous expired-air measure-
ments are collected for a period of two minutes.
Cardiac output can then be derived from oxygen con-
sumption and arterial and venous oxygen values.
Intracardiac electrocardiography is performed si-
multaneously with pressure measurements for analy-
sis of the tricuspid valve. The electrode is incorporated
into the tip of the catheter and drawn through the
valve to detect a signal change. Typical plug-in mod-
ules include those for ECG, ECG/His (bundle of His),
respiration, temperature, phonocardiograph signals,
hemoglobin oxygen saturation (SpO2), invasive pres-
sures, and cardiac output.
ECG/His amplifiers receive signals from electrode
catheters placed inside the various chambers of the
heart and from electrodes on the chest. Studies of the
bundle of His provide an assessment of the heart’s
electrical conduction system.
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Phonocardiography aids in diagnosing structural
heart abnormalities by measuring heart sounds that
are picked up by special microphones placed on the
chest. These sounds can then be compared simultane-
ously with either pulse or ECG waveforms.
Most systems allow waveforms to be frozen on the
monitor. 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.
Reported problems
Most problems associated with hemodynamic moni-
toring and recording involve inserting, advancing, and
maintaining the catheter. These problems include he-
matomas, infection, vascular damage, thrombosis, me-
chanically induced electrical irritation and
arrhythmias, catheter clotting, and balloon rupture.
Other common problems are poor electrode prepara-
tion and placement.
The hazard of electric shock to patients must be
considered in any room where electrical equipment is
used — particularly in the cath lab, where the catheter
provides a direct pathway for current to travel to the
conduction system of the heart. A safe power distribu-
tion system and its associated grounding are essential,
as are isolated electrical inputs on all equipment that
may come in contact with the patient and periodic
inspection and measurement of interequipment leak-
age currents. In the United States, the electrical wir-
ing and fittings must be installed in accordance with
the U.S. National Electrical Code and the standard for
safe use of electricity in healthcare facilities (see
Standards and Guidelines below).
Purchase considerations
Although each manufacturer’s system is configured
differently, most allow some flexibility in adapting
their configurations to the particular needs of the
hospital. Therefore, when choosing a system, it is im-
portant that the hospital consider its present and fu-
ture needs, space limitations, and patient volume. For
example, the hospital should consider whether the sys-
tem will be used for only diagnostic catheterizations or
for both diagnostic and therapeutic procedures.
The number of channels and paper speeds provided
by the recording system should correspond to the in-
stitution’s applications. The type of recorder used (e.g.,
thermal or laser printer) may vary; a high degree of
clarity and accuracy is most important. Hard copies
are not necessarily produced. Systems now employ
3
Healthcare Product Comparison System
recorders that allow the recording of overlapping
waveforms. In addition, the type and cost of paper
required for each recorder vary significantly. If paper
records are kept, each procedure requires a large
amount of paper, which has a significant effect on the
long-term cost of the system. However, waveforms are
typically stored digitally in current systems.
Monitors used in cath labs are modular, allowing
additional capabilities to be added later as the needs
of the lab change. Current systems usually include
pulse oximetry capabilities.
Data communications and data storage capabilities
vary among systems. Communications capabilities can
link the cath lab to other cath labs, to central worksta-
tions, to personal computers (PCs), or to hospital data
management systems. Storage capabilities include vari-
ous hard-disk capacities and can also include streaming
tape or compact discs (CDs). Recordable CD technology,
known as CD-R, is capable of storing a patient’s cardiac
catheterization study on a single, low-cost disk. Hospitals
should consider their communication and storage needs
before making a purchase decision.
Many systems offer capabilities for electrophysiology
procedures in addition to cardiac catheterization proce-
dures. Hospitals should consider such capabilities when
purchasing a new system. The decision may depend on
the volume of electrophysiology procedures performed,
since the procedures can be time-consuming. A dedicated
electrophysiology room with its own system may be
required if there are a significant number of procedures
performed. However, some facilities may be able to use
the same room and a system with dual capabilities for
both electrophysiology and cardiac catheterization.
Many systems have digitization hardware and soft-
ware available for ventriculography or coronary arte-
riography. Depending on the system, these functions
can be performed at a central workstation, on the cath
lab computer, or on a PC.
Stage of development
The basic functions of physiologic monitors in cath
labs have changed little since these labs were first
developed. One major trend is the increased comput-
erization for automated calculations, digital storage,
and networking. Automated calculations obviate the
need for staff to spend time on calculations based on
data provided by the monitoring system. Digital stor-
age is also becoming an increasingly popular method
of image archiving and allows for easier access to
images throughout a hospital via system networking.
The development of a catheter with a Doppler device
that can measure Doppler frequency shifts has made
4 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
it possible to calculate coronary flow velocity, which
can provide quantitative information about the condi-
tion of the heart. However, the capability to calculate
and store such information is not a part of currently
marketed monitors.
Bibliography
Bach RG, Donohue TJ, Kern MJ. Intracoronary Dop-
pler flow velocity measurements for the evaluation
and treatment of coronary artery disease. Curr Opin
Cardiol 1995 Jul;10(4):434-42.
Connors AF, Speroff T, Dawson NV, et al. The effec-
tiveness of right heart catheterization in the initial
care of critically ill patients. JAMA 1996 Sep
18;276(11):889-97.
Dalen JE, Bone RC. Is it time to pull the pulmonary
artery catheter? JAMA 1996 Sep 18;276(11):916-8.
Judkins MP. Guidelines for electrical safety in the
cardiac catheterization laboratory. Cathet
Cardiovasc Diagn 1984;10(3):299-301.
Levin AR. The science of cardiac catheterization in the
diagnosis of congenital heart disease. Cardiovasc
Clin 1972;4(3):235-73.
Reed CC, Clark DK. Cardiopulmonary perfusion.
Houston: Texas Medical Press; 1975.
Rushmer RF. Cardiovascular dynamics. 4th ed. Phila-
delphia: WB Saunders; 1976.
Swan HJ, Ganz W. Measurement of right atrial and
pulmonary arterial pressures and cardiac output:
clinical application of hemodynamic monitoring. In:
Stollerman GH, ed. Advances in internal medicine.
Vol. 27. Chicago: Year Book Medical Publishers;
1982:453-73.
Standards and guidelines
Note: Although every effort is made to ensure that the
following list is comprehensive, please note that other
applicable standards may exist.
American Association of Physicists in Medicine. Evalu-
ation of radiation exposure levels in cine cardiac
catheterization laboratories [report]. Cine Task Force
of the Diagnostic Radiology Committee. 12. 1984.
American College of Cardiology. Cardiac angiography
without cine film: erecting a “tower of babel” in the
cardiac catheterization laboratory [position state-
ment]. Cardiac Catheterization Committee. J Am
Coll Cardiol 1994 Sep;24(3):834-7.
 Physiologic Monitoring Systems, Cardiac Catheterization
American College of Cardiology/American Heart Asso-
ciation. ACC/AHA guidelines for cardiac catheteri-
zation and cardiac catheterization laboratories. Ad
Hoc Task Force on Cardiac Catheterization. J Am
Coll Cardiol 1991 Nov;18(5):1149-82.
American Heart Association. Pediatric therapeutic
cardiac catheterization [statement]. Council on Car-
diovascular Disease in the Young. Circulation 1998
Feb 17;97(6):609-25.
American National Standards Institute/Association
for the Advancement of Medical Instrumentation.
Safe current limits for electromedical apparatus
[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-
vised 1993).
International Electrotechnical Commission. Medical
electrical equipment — part 1: general require-
ments for safety [standard]. IEC 60601-1 (1988-12).
1988.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 1 [standard].
IEC 60601-1-am1 (1991-11). 1991.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 2 [standard].
IEC 60601-1-am2 (1995-03). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 1. Collateral standard:
safety requirements for medical electrical systems.
IEC 60601-1-1 (1992-06). 1992.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 1. Collateral standard:
safety requirements for medical electrical systems.
Amendment 1 [standard]. IEC 60601-1-1-am1 (1995-
11). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 2. Collateral standard:
electromagnetic compatibility — requirements and
tests. IEC 60601-1-2 (2001-09). 2001.
National Fire Protection Association/American Na-
tional Standards Institute. Health care facilities
[standard]. ANSI/NFPA 99-1996. 1999.
National electrical code. ANSI/NFPA 70-1996.
1996.
Ohio Nurses Association. Role of the registered nurse
in the cardiac catheterization laboratory [state-
ment]. NP 65. 1992 (revised 1995).
Ontario Ministry of Health and Long-Term Care.
Hemodynamic monitoring: a technology assess-
ment. Technology Subcommittee of the Working
Group on Critical Care. Can Med Assoc J 1991
Jul;145(2):114-21.
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Society for Cardiac Angiography and Interventions.
Guidelines for continuous quality improvement in
the cardiac catheterization laboratory. Cathet
Cardiovasc Diagn 1993 Nov;30(3):191-200.
Guidelines for electrical safety in the cardiac
catheterization laboratory. Laboratory Perform-
ance Standards Committee. Cathet Cardiovasc
Diagn 1984;10(3):299-301.
Guidelines for freestanding cardiac catheterization
laboratories. Laboratory Performance Standards
Committee. Cathet Cardiovasc Diagn 1989
Sep;18(1):60-1.
Guidelines for professional staff privileges in the
cardiac catheterization laboratory. Laboratory Per-
formance Standards Committee. Cathet Cardiovasc
Diagn 1990 Nov;21(3):203-4.
Minimal standards for a pediatric catheterization
and cineangiographic laboratory. Laboratory Per-
formance Standards Committee. Cathet Cardiovasc
Diagn 1983;9(6):617-8.
Citations from other ECRI publications
Health Technology Trends
Buying cardiac cath lab equipment? Don’t go filmless
yet. 1994 Oct:7.
Healthcare Risk Control
Technology overview: critical care. 1996 Jan;4:Critical
care:2.
Supplier information
GE Medical Systems
GE Medical Systems Asia (Japan) [300443]
4-7-127 Asahigaoka
Hino-shi
Tokyo
Japan
Phone: 81 (3) 425855451
Internet: http://www.gemedical.co.jp
GE Medical Systems Co Inc (Malaysia) [401861]
25/Fl UBN Tower
No 10 Jalan P Ramlee
50250 Kuala Lumpur
Malaysia
Phone: 60 (3) 2076424
Fax: 60 (3) 20799315
E-mail: info@gemedicalsystems.com
Internet: http://www.gemedicalsystems.com
5
Healthcare Product Comparison System

GE Medical Systems Europe [171319] Quinton Instrument Co (Europe) [171233]

283 rue de la Miniere Planetenweg 83
boite postale 34 NL-2132 HL Hoofddorp
F-78533 Buc Cedex The Netherlands
France Phone: 31 (23) 5672400
Phone: 33 (1) 30704040 Internet: http://www.quinton.com
Fax: 33 (1) 30709855
E-mail: info@gemedicalsystems.com Siemens
Internet: http://www. gemedicalsystems.com Siemens AG
GE Medical Systems Information Technologies Siemens Medical Solutions
Monitoring Div [393580] Med AX MS1, Competitive Intelligence Diagnostic
8200 W Tower Ave and Interventional X-Ray
Milwaukee WI 53223-3219 Siemensstrasse 1
Phone: (414) 355-5000, (800) 558-5120 91301 Forchheim
Fax: (414) 357-3456 Germany
Internet: http://www.gemedicalsystems.com Phone: 49 (9191) 188943
Fax: 49 (9191) 189912
E-mail: Bernhard.Drexler@siemens.com
Mennen Medical Internet: http://www.siemensmedical.com
Mennen Medical Corp [101498] Siemens Canada Ltd [174735]
10123 Main St 2185 Derry Rd W
Clarence NY 14031 Mississauga ON L5N 7A6
Phone: (716) 759-6921, (800) 223-2201 Canada
Fax: (716) 759-2816 Phone: (905) 819-8000, (888) 303-3353
E-mail: info@mennenmedical.com Fax: (905) 819-5777
Internet: http://www.mennenmedical.com E-mail: webdesign@it.siemens.ca
Mennen Medical France [186156] Internet: http://www.siemens.ca
Zone d’Activites des Bellevues Siemens Medical Solutions USA Inc [399199]
rue du gros Murger Batiment Technosite 186 Wood Ave S
F-95613 Cergy Pontoise Cedex Iselin NJ 08830-2704
France Phone: (732) 321-4500
Phone: 33 (1) 34488485 Fax: (732) 321-4780
Fax: 33 (1) 34488133 E-mail: sales@siemensmedical.com
Internet: http://www.mennenmedical.com Internet: http://www.siemensmedical.com
Mennen Medical Ltd Siemens SA de CV [339105]
Div Charthouse Group International [171234] Poniente 116 No 590
Kiryat Weizmann Science Park 02300 Cd de Mexico
PO Box 102 Distrito Federal
Rehovot IL-76100 Mexico
Israel Phone: 52 (5) 3282000
Phone: 972 (8) 9383030 Fax: 52 (5) 3282017
Fax: 972 (8) 9383089 Internet: http://www.siemens.de
E-mail: consumablesintl@mennenmedical.com
TEB
Internet: http://www.mennenmedical.com
TEB (Tecnologia Eletronica Brasileira Ltda)
[174429]
Quinton
Avenida Diederichsen 1057-1059
Quinton Instrument Co [101891] Vila Guarani
3303 Monte Villa Pkwy 04310-000 Sao Paulo-SP
Bothell WA 98021-8906 Brazil
Phone: (425) 402-2000, (888) 784-6866 Phone: 55 (11) 50178555
Fax: (425) 402-2001 Fax: 55 (11) 50176472
E-mail: kathe_cooper@quinton.com E-mail: export@teb.com
Internet: http://www.quinton.com Internet: http://www.teb.com

6 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Physiologic Monitoring Systems, Cardiac Catheterization

Witt Biomedical CO — Cardiac output

Witt Biomedical Corp [152577] CRT — Cathode-ray tube
305 North Dr Suite H
Melbourne FL 32934-9261 CSA — Canadian Standards Association
Phone: (321) 253-5693, (800) 669-1328
Fax: (321) 253-0372 DAT — Digital audiotape
E-mail: rhurley@wittbiomedical.com DICOM — Digital Imaging and Communications in
Internet: http://www.wittbiomedical.com Medicine standard

About the chart specifications ECG — Electrocardiogram

The following terms are used in the chart: EP — Electrophysiology
Configuration: Systems are housed in various types of
ETCO2 — End-tidal carbon dioxide
cabinets, including horizontal and vertical consoles,
vertical racks, and mobile carts. Some consoles can ETL — ETL Testing Laboratories
also be mounted on wheels.
FDA — U.S. Food and Drug Administration
Maximum channels: The maximum number of modules
that can be plugged into the unit and operated at GB — Gigabyte
one time.
HDD — Hard disk drive
Annotations: Alphanumerics printed as part of the
hard-copy record (e.g., patient data, messages, real- HL7 — Health level 7
time clock).
HR — Heart rate
Event markers: Markers printed on the record to note
significant events (e.g., time of injection). HW — Hardware
Line selections: Different line selections provide refer- IBP — Invasive blood pressure
ence points for the trace. These lines can be in the
form of a grid, such as on graph paper, or a series of IEC — International Electrotechnical Commission
lines, such as timing lines.
IECG — Intracardiac electrocardiograph
Recorder/computer interface: The system can be inter-
faced with a tape recorder or computer system for ISO — International Organization for Standardiza-
data storage and analysis. tion
Integral computer: Some systems are equipped with a MDD — Medical Devices Directive
computer to run analytical programs and perform
other tasks. NFPA — National Fire Protection Association
Abbreviations: NIBP — Noninvasive blood pressure
AAMI — Association for the Advancement of Medi-
cal Instrumentation NTSC — National Television Systems Commission

ACC — American College of Cardiology PC — Personal computer

ADT — Admission/discharge/transfer
AHA — American Hospital Association
ANSI — American National Standards Institute
ARO — After receipt of order
ASCII — American Standard Code for Information
Interchange
CD-R — Recordable compact disc
CD-ROM — Compact disc — read-only memory
CD-RW — Rewritable compact disc
CE mark — Conformite Europeene mark
QRS — Component of the ECG waveform
RAM — Random-access memory
SCSI — Small computer system interface
SECG — Surface electrocardiograph
SaO2, SpO2 — Hemoglobin oxygen saturation
SW — Software
TCP/IP — Transmission Control Protocol/Internet
Protocol
UL — Underwriters Laboratories

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 7
Healthcare Product Comparison System

Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
independent testing by ECRI or any other agency.
Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, prod-
ucts and specifications are subject to frequent changes.
ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
quences 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 com-
parison 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
hpcs@ecri.org (e-mail).

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8 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Physiologic Monitoring Systems, Cardiac Catheterization

Product Comparison Chart

MODEL GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS MENNEN MEDICAL

MAC-LAB 2000 MAC-LAB 4000 MAC-LAB 7000 HORIZON 9000 WS

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes

CONFIGURATION Modular, fixed desk, Modular, fixed desk, Modular, fixed desk, Console
mobile cart, PC- mobile cart, PC- mobile cart, PC-
based hardware based hardware based hardware
MAXIMUM CHANNELS 4 IBP, 12 ECG 4 IBP, 12 ECG 4 IBP, 12 ECG 32
PLUG-IN MODULES Integrated 12-lead Integrated 12-lead Integrated 12-lead 12-lead ECG, 4
ECG, SpO2, up to 4 ECG, SpO2, up to 4 ECG, SpO2, up to 4 pressures, SaO2,
IBP, NIBP, TDCO, IBP, NIBP, TDCO, IBP, NIBP, TDCO, NIBP, respiration,
analog output sync analog output sync analog output sync cardiac output,
on transportable on transportable on transportable temperature, 4
module (TRAM) module (TRAM) module (TRAM) auxiliary inputs

DISPLAY 1-18" flat panel * 2-18" flat panel * 2-18" flat panel * High-res color CRT
Traces Up to 12 Up to 12 Up to 12 32
Sweep speeds, mm/s 5, 10, 25, 50, 100, 5, 10, 25, 50, 100, 5, 10, 25, 50, 100, 6.25, 12.5, 25, 50,
200, 400, user- 200, 400, user- 200, 400, user- 100, 200
entered value entered value entered value
RECORDER Laser, thermal array Laser, thermal array Laser, thermal array Thermal array

Traces 12 12 12 24
Paper speeds, mm/s 5, 12.5, 25, 50 5, 12.5, 25, 50 5, 12.5, 25, 50 1-10, 25, 50, 100

Annotations Name, ID, paper Name, ID, paper Name, ID, paper Name, ID, date, ECG
speed, ECG and speed, ECG and speed, ECG and leads, time,
waveform grids, waveform grids, waveform grids, text pressure scales,
text header, text header, header, date/time pressure sites, HR,
date/time date/time respiration, time-
lines, pulse
oximetry

Event markers Yes Yes Yes Yes

Line selections ECG grid, vertical ECG grid, vertical ECG grid, vertical Timing, calibration
grid, mm rule grid, mm rule grid, mm rule grid selectable
ELECTROPHYSIOLOGY See footnote ** See footnote ** See footnote ** Yes
Number of channels Up to 32 Up to 96 Up to 128 32

Online analysis Yes Yes Yes Yes

Automated interval
measurements Yes Yes Yes No

Colons separate data on similar models of a device. This is the first of

* 1280 x 1024 resolution. three pages covering
** ComboLab with addition of CardioLab EP system. the above model(s).
These specifications
continue onto the
next two pages.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 9
Healthcare Product Comparison System

Product Comparison Chart

MODEL GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS MENNEN MEDICAL

MAC-LAB 2000 MAC-LAB 4000 MAC-LAB 7000 HORIZON 9000 WS

RECORDER/COMPUTER
INTERFACE Yes/yes Yes/yes Yes/yes Yes/yes
INTEGRAL COMPUTER 933 MHz Pentium III, 933 MHz Pentium III, 933 MHz Pentium III, Single Ultra SPARC
Windows NT operating Windows NT operating Windows NT operating Sun computer
system system system

Hemodynamic calc Yes Yes Yes Yes

Pediatric software Yes Yes Yes Yes

Applications
Data management Yes Yes Yes Clinibase solution
Stats analysis Yes Yes Yes Clinibase solution
Inventory control Yes * Yes * Yes * Clinibase solution
Report generator MS Word based MS Word based MS Word based H9000WS document
processor
Other Integrated schedul- Integrated schedul- Integrated schedul- Clinibase provides
ing optional ing optional ing optional ACC and NCDR
reporting module
Storage, MB 18 GB HDD, 2.6 GB 18 GB HDD, 2.6 GB 18 GB HDD, 2.6 GB 96 RAM, 3 GB hard
optical, 36-140 GB optical, 36-140 GB optical, 36-140 GB disk, 1.3 GB optical
server server server disk

LAB NETWORKING See footnote ** See footnote ** See footnote ** Yes

HIS INTERFACE ADT, optional orders ADT, optional orders ADT, optional orders Yes

NATIONAL CARDIOLOGY
DATABASE INTERFACE ACCAccess optional ACCAccess optional ACCAccess optional Yes

X-RAY IMAGE DISPLAY No Optional Optional Online in window

Source NA Any video Any video Video, cine

projector, or other
video source
Ventriculography NA Optional Optional Yes
Angiography NA Optional Optional Yes
Frame grabbing NA Optional Optional Yes
Zoom NA Yes Yes Yes

Other Bidirectional Bidirectional Bidirectional None specified

interface with GE interface with GE interface with GE
DLX x-ray systems DLX x-ray systems DLX x-ray systems

Colons separate data on similar models of a device. This is the second of

* Optional bar-code scanner. three pages covering
** List sharing and supplies synchronization using CardioLink server, pre/post OP stations for holding area integration the above model(s).
with vitals monitoring, simultaneous data entry with nurses station, remote view access to waveforms and report analysis. These specifications
continue onto the
next page.

10 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Physiologic Monitoring Systems, Cardiac Catheterization

Product Comparison Chart

MODEL GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS GE MEDICAL SYSTEMS MENNEN MEDICAL

MAC-LAB 2000 MAC-LAB 4000 MAC-LAB 7000 HORIZON 9000 WS

OPERATING TEMP, °C 5-40 5-40 5-40 0-32

RELATIVE HUMIDITY, % 15-95, non- 15-95, non- 15-95, non- 30-75, noncondensing
condensing condensing condensing
LINE POWER, VAC 110/220 110/220 110/220 110/220, 50/60 Hz

H x W x D, cm (in) 32 x 32 x 30 32 x 40 x 30 32 x 40 x 30 115.6 x 130.8 x 83.8

(12.6 x 12.6 x 11.8) (12.6 x 15.7 x 11.8) (12.6 x 15.7 x 11.8) (45.5 x 51.5 x 33),
with casters with casters with casters console and display

WEIGHT, kg (lb) ~250 (551.3) ~300 (661.5) ~300 (661.5) 147.4 (325) console
and display
PURCHASE INFORMATION
Price $50,000 $75,000 $100,000 Not specified

Warranty 1 year, parts and 1 year, parts and 1 year, parts and 1 year
labor labor labor
Delivery time, ARO 45 days 45 days 45 days 12 weeks

Service contract Variable plans Variable plans Yes 5-10% of purchase

price per year
Year first sold 2000 NT, 1987 2000 NT, 1987 2000 NT, 1987 1994
Classic Series Classic Series Classic Series
Number installed
USA 10 10 1,200 300
Worldwide 40 50 2,500 500
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Full disclosure; Full disclosure; User-defined macros Integrated
remote modem remote modem to automate tasks; information
support; dual support; dual full disclosure; management;
hemo/EP capability. hemo/EP capability. remote modem multitasking and
support; dual multiuser systems;
hemo/EP capability; integrated document
coronary tree processing; dual
diagrams; vitals network for true
alert; ECG tone and open architectural
Nellcor Oxysmart or integrated SaO2,
Massimo for SpO2. NIBP, CO, and 12-
lead ECG; peripheral
pressure analysis
available as
optional software
module.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 11
Healthcare Product Comparison System

Product Comparison Chart

MODEL QUINTON SIEMENS SIEMENS TEB

Q-Cath System CATHCOR LX CATHCOR LX Desktop SP12/32

WHERE MARKETED Worldwide Worldwide Worldwide Mexico/South America

FDA CLEARANCE Yes Yes Yes No
CE MARK (MDD) Optional Yes Yes No

CONFIGURATION Modular; optional Fixed table, compact Small, PC-like Cart mounted
stationary or mobile
table
MAXIMUM CHANNELS 26; 6 displayed 12 12 38
PLUG-IN MODULES 12-lead SECG, 4 IBP, Inputs available in Inputs available in Integral functions
4 invasive mean an integrated input an integrated input include 12 SECG, 18
pressures, NIBP, box: 12-channel sur- box: 12-channel sur- IECG, 3 invasive
4 dp/dt, 2 DC, 1 face ECG, 4 pres- face ECG, 4 pres- pressures, thermal
analog ECG/pressure sures, 4 universal sures, 4 universal dilution, 4 external
output, NIBP, inputs, 2 analog inputs, 2 analog outputs
6 IECG, SpO2, outputs, 1 QRS sync outputs, 1 QRS sync
cardiac output, output, interface to output, interface to
optional interface Nellcor SpO2, Nellcor SpO2,
to peripheral Critikon NIBP and Critikon NIBP and
monitoring devices Siemens SCX000 pat- Siemens SCX000 pat-
ient monitors (CO, ient monitors (CO,
SpO2, NIBP, resp) * SpO2, NIBP, resp)
DISPLAY See footnote ** High-res color CRT High-res color CRT 2 high-res color CRT
Traces 6 1-14, user config 1-14, user config 32
Sweep speeds, mm/s 12.5, 25, 50, 100 12.5, 25, 50, 100 12.5, 25, 50, 100 12.5, 25, 50, 100,
200 in free-running
or trigger mode
RECORDER Thermal array, HP Thermal array Laser printer Thermal array
LaserJet 4100 (built-in) and laser (external)
printer printer (external)
Traces 12 1-12, user config NA 32
Paper speeds, mm/s 5, 25, 50, 100 2.5, 5, 10, 25, 50, NA 12.5, 25, 50, 100 in
100, 200 real time; 200 in
non-real-time
Annotations Name, date, time, Patient ID, clock/ Patient ID, clock/ Date, time, lead,
paper speed, range calendar, pressures, calendar, pressures, patient ID, gain,
labels, pressure HR, valve area, raw HR, valve area, raw paper speed
data, HR, elapsed data, demographics data, demographics
time, analysis
results (pressure &
valve), case number,
vital signs, 3 user-
defined grid lines ***
Event markers Sample waveform Time marker, Time marker, Time grid
marker, manual event sample points sample points
marker
Line selections Up to 3 (vertical, Millimeter ruled Millimeter grid Not specified
ECG grid, horizon)
ELECTROPHYSIOLOGY Yes Yes Yes Yes
Number of channels 6 with 18 inputs 12 IECG 12 IECG 18

Online analysis No Time measurement Time measurement Yes

Automated interval
measurements No Vertical cursors Vertical cursors Yes

Colons separate data on similar models of a device. This is the first of

* Optional 12-channel analog output interface. three pages covering
** 17" or 22" flat-screen ultra high-resolution monitors or 15" flat-panel LCD monitor. the above model(s).
*** Also site labels and interval time lines. These specifications
continue onto the
next two pages.

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 Physiologic Monitoring Systems, Cardiac Catheterization

Product Comparison Chart

MODEL QUINTON SIEMENS SIEMENS TEB

Q-Cath System CATHCOR LX CATHCOR LX Desktop SP12/32

RECORDER/COMPUTER
INTERFACE Yes/yes Yes/yes No/yes Yes/yes
INTEGRAL COMPUTER Pentium III PC w/Pentium II 233 PC w/Pentium III 750 AMD K6-II 500 MHz
1.13 GHz, 256 MB MHz (or more), net- MHz, network inter-
RAM, 20 GB HD, work interface, 64 face, 128 MB RAM,
1.4 MB floppy drive, MB RAM (or more), 8 30 GB hard drive,
CD-ROM, 8 GB tape GB hard drive (or 8 GB tape streamer *
drive, Windows XP more) **
Hemodynamic calc Yes Yes Yes Yes

Pediatric software Yes Yes Yes Yes

Applications
Data management Yes Yes Yes No
Stats analysis Yes Opt query wrkstation Opt query wrkstation Yes
Inventory control Yes Opt inven wrkstation Opt inven wrkstation No
Report generator Yes Yes Yes Yes

Other See Other Optional bar-code Optional bar-code None specified

Specifications scanning, flat scanning, flat
screens *** screens
Storage, MB Interface to ORION 8 GB (>100,000 8 GB (>100,000 20 GB
2000 cardiovascular patient files) patient files)
information manage-
ment system for data
collection †
LAB NETWORKING TCP/IP, MLLP Ethernet TCP/IP Ethernet TCP/IP No
open architecture open architecture
HIS INTERFACE Yes, ADT or HL7 ASCII file ASCII file No
optional transfers, transfers,
bidirectional †† bidirectional
NATIONAL CARDIOLOGY
DATABASE INTERFACE ACC and STS Data collected and Data collected and No
certified registry sent to Siemens CDMS sent to Siemens CDMS
database (cardiology data (cardiology data
management system) ††† management system)
X-RAY IMAGE DISPLAY Single images or Optional image Optional image No
cine acquisition analysis system analysis system
through Quinton (QUANTCOR) (QUANTCOR)
qualified vendor
Source Any digital cine Any standard NTSC Any standard NTSC NA
loop video signal video signal

Ventriculography Yes Yes Yes NA

Angiography Yes Yes Yes NA
Frame grabbing Yes Yes Yes NA
Zoom Yes Yes Yes NA

Other Interfaces with Images printed on Images printed on NA

multiple image plain-paper laser plain-paper laser
management printer with printer with
suppliers (export calculations, auto- calculations, auto-
demographic data to matic database down- matic database down-
image-acquisition load to CATHCOR LX load to CATHCOR LX
systems and import
cine images)

Colons separate data on similar models of a device. This is the second of

* With SCSI connection; Specialix I/O 8+ serial ports; Linux redhat 5.2 and kernel 2.0 36 operating system; Informix three pages covering
4 GL 7.20.UD7 database; Informix SE+ ESQL 7.24.UC5-1. the above model(s).
** Tandberg SLR-5 with SCSI connection 4 GB tape streamer; Specialix I/O8+ serial ports; Linux redhat 5.2; Kernel 2.0 36 These specifications
operating system; Informix SE+ ESQL 7.24.UC5-1 database. continue onto the
*** Angio interface, image analysis, congenital heart picture, coronary tree report, case recorder. next page.
†
Also export to Q-Cath patient file to third-party systems; 20 MB hard drive, DAT tape, CD-RW.
††
Optional DICOM/HL7 communication kit (CATHCOR Talk).
†††
ACC and STS certified.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 13
Healthcare Product Comparison System

Product Comparison Chart

MODEL QUINTON SIEMENS SIEMENS TEB

Q-Cath System CATHCOR LX CATHCOR LX Desktop SP12/32

OPERATING TEMP, °C 16-32 10-40 10-40 15-35

RELATIVE HUMIDITY, % Up to 90, 30-75 30-75 15-85, noncondensing
noncondensing
LINE POWER, VAC 100, 120, 220, 230, 100-120, 220-240 100-120, 220-240 110/220, 50/60 Hz
240, 20 A
H x W x D, cm (in) 71.1 x 55.4 x 60 116 x 125 x 80 44.6 x 20.5 x 51.6 150 x 170 x 75
(28 x 21.8 x 23.6) (45.7 x 49.2 x 31.5) (17.6 x 8.1 x 20.3) (59.1 x 66.9 x 29.5)
computer cabinet; table; central unit;
78 x 119.9 x 92.9 150 x 85 x 58 36 x 95 x 33.2
(30.1 x 47.2 x 36.6) (59.1 x 33.5 x 22.8) (14.2 x 37.4 x 13)
optional table compact, wheels;
130 x 85 x 58
(51.2 x 33.5 x 22.8) *
WEIGHT, kg (lb) 228.4 (503.6) with ~115 (250) ** ~29 (63.9) 50 (110.3)
table and 2 monitors
PURCHASE INFORMATION
Price $85,000; See Other Not specified Not specified $35,000
Specifications

Warranty 1 year 1 year 1 year 1 year, parts/labor

Delivery time, ARO 45 days 4-5 weeks 4-5 weeks 4-6 weeks

Service contract Varies Not specified Not specified No

Year first sold 1998 1993 2001 1994

Number installed
USA 500 Not specified Not specified NA
Worldwide 100 Not specified Not specified 280
Fiscal year January to December October to September October to September January to December
OTHER SPECIFICATIONS Includes QCA and Multitasking, multi- Multitasking, multi- Optional program-
ventricular image user system for user system for mable simulator;
analysis and virtually unlimited virtually unlimited continous storage on
bidirectional number of number of hard disk; CD-R to
import/export data- simultaneous users simultaneous users save stored data at
exchange software; without loss of without loss of procedure's end;
Q-Cath software, performance; performance; Windows-based soft-
Q-Cath Data DICOM/HL7 DICOM/HL7 ware for data review
Exchange program, communication communication on standard PC.
Q-Cath Exchange through optional through optional Registered product
software; list price CATHCOR Talk. CATHCOR Talk. in the Brazilian
includes two 17" Meets requirements Meets requirements Ministry of Health.
control room of IEC 601-1, IEC SC of IEC 601-1, IEC SC
monitors, one 22" 62D, and UL 544. 62D, and UL 544.
remote procedure
room monitor, table,
and laser printer.
Meets requirements
of AAMI/ANSI, CSA,
ETL, IEC 601, and
UL.

Colons separate data on similar models of a device.

* Compact, without wheels.
** Depending on optional hardware.

14 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Physiologic Monitoring Systems, Cardiac Catheterization

Product Comparison Chart

MODEL WITT BIOMEDICAL

Series IV

WHERE MARKETED Worldwide

FDA CLEARANCE Yes
CE MARK (MDD) Yes

CONFIGURATION Modular, console

MAXIMUM CHANNELS 25 active

PLUG-IN MODULES 12 ECG, 4 pressures,
NIBP and SpO2 (inte-
grated), thermal
cardiac output and
bath probe,
respiration, ETCO2

DISPLAY Color CRT w/alphanum

Traces Up to 25
Sweep speeds, mm/s 5, 12.5, 25, 50,
100, 200, 400, user-
defined
RECORDER LaserJet V

Traces Up to 25
Paper speeds, mm/s 5-400

Annotations Patient ID, date,

time, paper spd, HR,
pressures, pressure
site, pressure
scale, elapsed time,
gradients, valve
calculations, CO,
simultaneous wave-
forms, menu-driven
Event markers Time marker,
sampling marker,
event marker
Line selections Millimeter ruled

ELECTROPHYSIOLOGY No
Number of channels NA

Online analysis NA

Automated interval
measurements NA

Colons separate data on similar models of a device. This is the first of

three pages covering
the above model(s).
These specifications
continue onto the
next two pages.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 15
Healthcare Product Comparison System

Product Comparison Chart

MODEL WITT BIOMEDICAL

Series IV

RECORDER/COMPUTER
INTERFACE Yes/yes
INTEGRAL COMPUTER 750 MHz or greater
processor, 128 MB
RAM, 20 GB or
greater hard drive

Hemodynamic calc Yes

Pediatric software Yes

Applications
Data management Yes
Stats analysis Yes
Inventory control Yes
Report generator MS Word, XML

Other Coronary tree anno-

tation, user-defined
conscious settings *
Storage, MB 20 GB or greater
with hard drive
backup, optional DAT
backup

LAB NETWORKING Yes

HIS INTERFACE HL7 compliant

NATIONAL CARDIOLOGY
DATABASE INTERFACE ACC, IBS, Apollo,
Goodroe, any HL7-
compliant supplier

X-RAY IMAGE DISPLAY Yes

Source DICOM 3.0, video

Ventriculography Yes
Angiography Yes
Frame grabbing Optional
Zoom Yes

Other Center-line wall

motion, % stenosis,
vessel diameter,
graphical coronary
tree, save to bit-
map, DICOM viewing,
HIPAA compliant

Colons separate data on similar models of a device. This is the second of

* Electronic signatures, scheduling, real-time posting. three pages covering
the above model(s).
These specifications
continue onto the
next page.

16 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Physiologic Monitoring Systems, Cardiac Catheterization

Product Comparison Chart

MODEL WITT BIOMEDICAL

Series IV

OPERATING TEMP, °C 5-30

RELATIVE HUMIDITY, % 20-80, noncondensing

LINE POWER, VAC 120

H x W x D, cm (in) 86.4 x 112.4 x 81.9

(34 x 44.25 x 32.25)

WEIGHT, kg (lb) 569.1 (258)

PURCHASE INFORMATION
Price $92,900 base price

Warranty 1 year

Delivery time, ARO 4-8 weeks

Service contract 10% of price; comp-

rehensive HW & SW
Year first sold 1997

Number installed
USA 670
Worldwide Not specified
Fiscal year January to December
OTHER SPECIFICATIONS Meets requirements
of AAMI, CSA, EN
460001 registration,
ISO 9001, NFPA 99,
and UL 544/2601-1.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 17