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Recorders, Electrocardiography Scanners, ECG

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43 views81 pages

Recorders, Electrocardiography Scanners, ECG

A10

Uploaded by

tuffaha1333
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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 Recorders, Electrocardiography; Scanners, ECG

Scope of this Product Comparison


This Product Comparison covers retrospective and real-time Holter recorders that store an electrocardiograph
signal on magnetic tape or electronic media. It also includes Holter scanners that are used to play back the
recorded electrocardiogram (ECG) signals for analysis. Specifications on 30-day event recorders are not included,
but an overview of the technology is discussed. Units that function exclusively as ECG event recorders are also
excluded.
These units are also called: Holter monitors, ambulatory electrocardiographs, ambulatory electrocardiogram
(AECG) scanners.
For further information on electrocardiograph technology, see the Product
Comparisons titled Electrocardiographs, Multichannel; Interpretive; Single-
Channel.

Purpose
Portable long-term electrocardiograph recorders detect and record a
patient’s ECG over an extended period of time (usually 6 to 48 hours) to detect
abnormalities in the heart’s electrical activity caused by routine daily activity
or heightened emotional or physical states. Typical ECG scanners either
analyze and display the recorded data or display data that has already been
analyzed by the recorder. AECG recording is most commonly used to detect
transient ventricular arrhythmias in symptomatic patients and in patients after
myocardial infarction. It is also used to monitor patients who report other
symptoms of possible cardiac origin (e.g., syncope, dyspnea, dizziness,
palpitations, angina), to assess the efficacy of treatment such as antiarrhythmic drug therapy, and to verify proper
pacemaker function; some models also record blood pressure. For more information on ambulatory blood
pressure monitoring, see the Product Comparison titled Recorders, Data, Blood Pressure. Standard 12-lead ECG
recording is frequently used as an adjunct to Holter monitoring
because it can define ECG abnormalities that require long-term
monitoring. Some models may allow derived 12-lead ECG UMDNS Information
analysis using 3 to 10 electrodes (number of electrodes varies by
This Product Comparison covers the following device
supplier). One supplier achieves 12-lead ECG analysis with 3 terms and product codes as listed in ECRI Institute’s
electrodes and 4 metal chest electrodes on the back side of the Universal Medical Device Nomenclature System™
recorder. The patient then positions the recorder in 3 different (UMDNS™):
Recorders, Electronic Storage, Data, Electrocardiography,
locations to get the 12-lead recording. Continuous [18-361]
Holter monitoring applications include detecting silent Recorders, Tape, Data, Electrocardiography, Continuous
[16-009]
ischemia, evaluating heart rate variability, and recording Scanners, Long-Term Recording, Electrocardiography
arrhythmogenic late potentials. [15-295]

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 hpcs@ecri.org
Recorders, Electrocardiography; Scanners, ECG

Principles of operation
There are two basic types of AECGs: retrospective and real time. The difference between the two technologies
is the point at which analysis is performed—after the data is recorded (retrospective) or during AECG monitoring
(real time). In retrospective systems, all the ECG data is typically recorded by a tape recorder and analyzed after
playback by a scanner. In real-time systems, the data is recorded, analyzed, and quantified by the recorder and
played back by the scanner. Some systems have both retrospective and real-time capabilities. Prospective
systems, a type of retrospective system, allow the technician to analyze and edit each arrhythmia event during
playback.
In both systems, the recorder typically consists of an electrocardiograph amplifier with three to five input leads
(which are attached to the patient using chest surface electrodes) coupled to either a tape recorder or an electronic
storage device. Real-time recorder systems also have a microprocessor that analyzes the ECG. The patient
typically wears the recorder supported by a shoulder strap or belt loop. Both real-time and retrospective systems
interface with personal or dedicated computers, which provide editing, storage, and reporting capabilities.
Tape-based scanners have a magnetic-tape reader that transfers the data to the computer. The scanner then
analyzes and quantifies the data and generates reports. In solid-state systems, the data is transferred from the
recorder to a scanner through an electronic interface or a removable data card. The technician then uses the
scanner to edit and print reports.
Retrospective recorders typically record up to 3 channels of ECG signals over a period of 6 to 48 hours. A
retrospective AECG scanner then reads the recordings at 60 to 240 times the recording speed, analyzing the tape
for arrhythmias and other irregularities.
Scanners in retrospective systems use one of three methods to analyze the AECG tapes and are categorized
according to the level of technician involvement: manual observer detection, semiautomated, and automated.

2 ©2008 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

 Manual observer detection—The technician identifies abnormal beats while the tape is scanned in
either a paging or a superimposition mode. In the paging mode, the technician typically surveys 1 to
10 minutes of ECG signals that are displayed on the screen (called a page) and has the option to print
the display. Subsequent pages are reviewed using the same procedure. In superimposition scanning,
successive ECG beats are superimposed over previous beats on the display screen. The technician
can stop the tape at any time to mark and classify abnormal beats. Some systems offer a combination
of paging and superimposition. In more automated systems, superimposition is aided by computer
analysis to identify aberrant beats.
 Semiautomated—When using this type of scanner, the technician must program the device to
identify which events are normal, abnormal, and artifact after determining the individual beat
structure based on initial scanning. The scanner catalogs these classifications, and all events are
sorted into a previously designated category. The technician can intercede at any time to correct
errors in classification. The scanner pauses automatically at events for which no category has yet
been established in its knowledge base.
 Automated—The device scans through the tape, automatically establishing beat classification bins
that categorize the abnormal beats according to the patient’s beat structure. The technician can
change, split, or merge the bins. In some automated systems, the technician can also operate the
device in a semiautomated mode.

Some suppliers may offer ECG analysis software (e.g., Windows based) that can be installed on existing
computers. The software will analyze the ECG, generate and print reports, and store ECG event data.
Virtually all retrospective systems include full disclosure (FD)—a continuous 24-hour ECG report in a
compressed format.
Real-time recorders analyze and quantify the ECG signal as it is being monitored. At the completion of a
study, the quantified information stored in the recorder-analyzer is transferred to a scanner (which, in real-time
systems, is sometimes called a playback device or a report generator). The scanner inputs and processes the
information to allow data storage and retrieval and printing. Many systems also permit editing similar to that of
automated retrospective systems by allowing the operator to manipulate bin classifications.
The amount of data that can be stored in real-time systems is limited by the electronic memory. To compensate
for this limitation, some real-time systems store only aberrant beats, although they count all beats. Most real-time
systems store all beats but compress the raw data using computer algorithms, enabling the system to produce an
FD report.
While the data compression used in real-time systems is necessary because of memory limitations, excessively
high compression ratios can create distortions when data is displayed or printed out. Unlike retrospective
systems, which have virtually no data storage limitations during a 24-hour AECG study, the electronic storage
used for FD in most real-time systems can necessitate a trade-off between the memory capacity and the fidelity of
the reproduced signal (several solid-state systems have been developed that have sufficient memory to store all
beats). Because the FD feature offers the only opportunity for comprehensive clinical review, ECRI Institute
recommends consistent use of FD in real-time systems.
Because arrhythmias and more subtle changes in the ECG signal often correlate with symptoms and activities,
patients frequently keep diaries during the recording. Digital clock displays on some units enable patients to
designate the time in their diary entries; some recorders also include push buttons that put a marker on the
recording media, allowing patients to annotate symptomatic periods. In addition, many systems automatically
annotate time and arrhythmia events.
Long-term event recorders are typically used for an extended period of time (from two days to eight weeks)
after a Holter study has not captured a cardiac event. As in a Holter study, patients wear a recorder during
normal activities. However, instead of the recorder capturing every heartbeat, patients activate the recording

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Recorders, Electrocardiography; Scanners, ECG

function when they feel symptomatic. This type of system requires patient compliance; therefore, if a cardiac
symptom incapacitates a patient, the system may not be useful. Some recorders have loop memory, which allows
the recorder to capture an event after it has occurred.
Clinicians can typically program each unit to record information before and after activation, allowing them to
program the amount of time they believe is most critical for a diagnosis. After the information has been recorded,
hospitals can interpret their own data, or the data can be sent by modem to a manufacturer’s receiving facility
where trained employees can analyze it.
Some suppliers offer a transtelephonic ECG transmitter (telemetry)
designed for remote real-time diagnosis of arrhythmias, ischemia, and
myocardial infarction. The handheld device transmits a complete 12-lead
ECG over telephone lines. A remote cardiac monitoring center interprets
the transmitted ECG using software for real-time diagnosis. The device
also has an external memory unit to store transient symptoms in 60-
second solid-state memory for later transmission and analysis. For more
information on telemetry, see the Product Comparison titled Physiologic
Monitoring Systems, Telemetric; ECG Monitors, Telemetric; Monitors,
Central Station.
Some suppliers offer transmission of ECG information over the
Internet. Once a recording has been taken at a remote site, the data is downloaded and transmitted. Transmission
time and speed depend on the amount of data, location (e.g., remote sites), and type of transmission lines.
One supplier listed in the chart uses a single-channel ECG monitor and event recorder built into a wristwatch.
The event recorder is activated by touching the face of the watch. Stored data is transmitted to a PC via optical
cable or standard modem.

Reported problems
For recorders that use magnetic tape, recorded heart rates can appear to increase toward the end of a
recording. This is usually due to slowing of the tape drive motor caused by depleted batteries. Units should be
regularly serviced to prevent mechanical problems that drain batteries excessively. Batteries should be new or
freshly charged at the beginning of a recording because it is difficult to evaluate tachycardia or bradycardia if
there is uncertainty about heart rate (see the charts for expected battery operation times). However, some units
have timing circuits that are powered by separate batteries or that are independent of changes in battery voltage.
These units superimpose timing signals on a separate channel of the recording and can determine heart or
pacemaker rates despite partially depleted batteries.
Occasionally, ECG recordings are poor quality or ECGs are not recorded at all because of improper electrode
placement, broken leads, mechanical failure, dried electrode gel, or poor electrode contact. Many portable long-
term ECG recorders have a test jack that can be used to check ECG signal quality after the patient is connected,
which can eliminate the need to repeat a recording.

Purchase considerations
ECRI Institute recommendations
Included in the accompanying comparison charts are ECRI Institute’s recommendations for minimum
performance requirements for Holter recorders and scanners.
FD capability must be available on all recorders to allow clinicians to review the entire waveform over the
entire monitored period; recorders should have a patient event marker and time stamp for all events. In real-time
systems, the recorder should be able to annotate arrhythmia detection. The recorder should be able to provide at

4 ©2008 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

least 24 hours of monitoring for at least 2 ECG channels, and the battery should operate the monitor for at least 24
hours; a rechargeable battery should not require more than 16 hours to recharge after depletion. Also, a battery-
powered Holter monitor should use a commonly available battery type that does not require frequent
replacement. Patient safety and system performance should not be adversely affected by fluid spills.
Retrospective, real-time, or combination scanners are acceptable. A tape-based retrospective scanner should
have a magnetic-tape reader to facilitate data transfer. Retrospective scanners should be capable of reading
recordings at 60 to 240 times the recording speed. A real-time scanner should have an electronic interface to
receive transferred data from the recorder. The scanner should analyze at least two channels; any scanning mode
is acceptable. The scanner should provide a time and heart-rate display, FD, and pacemaker analysis. Reports
should also indicate total beats and beats per hour for all types of beats (e.g., normal, ventricular,
supraventricular). An arrhythmia detection indicator and ST-segment analysis capability are required, as are
trend graphs for the R-R interval, ST-segment deviation, and ventricular beats. The patient’s strip should annotate
the time, patient identification, heart rate, and arrhythmias; FDs must be expanded on the strip. Data archiving
methods are selected by the facility.

Other considerations
Recorders range in price from $400 to $8,000; scanners range in price from $3,000 to $30,000. Like the purchase
price, the life-cycle costs of portable Holter systems vary; the determining factors depend on the degree of
technician involvement. When purchasing a recorder and scanner, hospitals should consider the following:
 Type of recorder and scanner
 Recording medium (e.g., magnetic tape, solid-state)
 Type of computer and printer
 Storage capabilities
 Software and interfacing accessories
 Number of input leads
In the United States, much controversy has been associated with the regulations concerning the classification
of recorders for Medicare reimbursement. These regulations vary from state to state and may change in the
future. The U.S. Centers for Medicare & Medicaid Services outlines the conditions necessary for authorization of
the use of diagnostic procedures.

Stage of development
In 1949, Norman Holter built the first AECG unit, which was actually an electrocardiograph radio transmitter
that required a separate receiver and recorder. Since then, units have decreased significantly in size and weight,
especially since the introduction of integrated circuits. Recording technology has also advanced, and now the
recording components are included in the ambulatory unit, resulting in better ECG signal quality than is usually
provided by radio transmission.
Since the early 1980s, Holter scanners have become increasingly automated and faster at processing data.
Technicians can generate reports in various formats and have greater flexibility in customizing them. Some
scanners offer hard-disk storage for patient reports and various data management software packages. Long-term
storage is available using floppy disks, hard disks, streaming tape, optical disk systems, or recordable compact
discs. Some scanners can also transmit data to doctors’ offices or other remote locations. Other refinements
include further size reductions, better signal quality, longer battery life, and digital clock displays for patient
reference.
Implantable ECG recorders have been introduced to improve the detection of arrhythmias. Once the recorder
is inserted under the skin, the patient uses a handheld activator to monitor the heart’s electrical activity. These
devices can store up to several hours of data and remain implanted for several months.

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Recorders, Electrocardiography; Scanners, ECG

Bibliography
Denes P. The importance of derived 12-lead electrocardiography in the interpretation of arrhythmias detected by
Holter recording. Am Heart J 1992 Oct;124(4):905-11.
Fogel RI, Evans JJ, Prystowsky EN. Utility and cost of event recorders in the diagnosis of palpitations,
presyncope, and syncope. Am J Cardiol 1997 Jan 15;79(2):207-8.
Heilbron EL. Advances in modern electrocardiographic equipment for long-term ambulatory monitoring. Card
Electrophysiol Rev 2002 Sep;6(3):185-9.
Hubelbank M. Holter monitoring state of the art: two steps forward and one back. J Electrocardiol
2002;35(Suppl):223-5.
Kennedy HL. Importance of the standard electrocardiogram in ambulatory (Holter) electrocardiography. Am
Heart J 1992 Jun;123(6):1660-77.
Kowey PR, Kocovic DZ. Cardiology patient pages: ambulatory electrocardiographic recording. Circulation 2003
Aug 5;108(5):e31-3.
Kühne M, Schaer B, Moulay N, et al. Holter monitoring for syncope: diagnostic yield in different patient groups
and impact on device implantation. QJM 2007 Dec;100(12):771-7.
Rao A, Lomax S, Ramsdale K, et al. Ambulatory cardiac rhythm monitoring. Br J Hosp Med 2007 Mar;68(3):132-8.

Supplier information
Note: The following list includes suppliers for both Chart A and Chart B.
ADVANCED BIOSENSOR
Advanced Biosensor Inc [359434]
400 Arbor Lake Dr Suite B450
Columbia, SC 29223-4571
Phone: (803) 407-3044, (800) 443-3816 Fax: (803) 407-3046
Internet: http://www.advancedbiosensor.com
E-mail: sales@advancedbiosensor.com

AEROTEL
Aerotel Medical Systems (1998) Ltd [162948]
5 Hazoref Street
Holon IL-58856
Israel
Phone: 972 (3) 5593222 Fax: 972 (3) 5596111
Internet: http://www.aerotel.com
E-mail: info@aerotel.com

APPLIED CARDIAC
Applied Cardiac Systems Inc [104071]
22912 El Pacifico Dr
Laguna Hills, CA 92653-1332
Phone: (949) 855-9366, (800) 423-2929 Fax: (949) 581-1009
Internet: http://www.appliedcardiacsystems.com

ASPEL
Aspel Sa [402131]
ulica Bratyslawska 2

6 ©2008 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Krakow PL-310201
Poland
Phone: 48 (12) 6220672 Fax: 48 (12) 6220668
Internet: http://www.aspel.com.pl
E-mail: agnieszka.niestoj@aspel.com.pl

BIOMEDICAL SYSTEMS
Biomedical Systems Corp [105010]
77 Progress Pkwy Bldg One
St Louis, MO 63043
Phone: (314) 576-6800, (800) 877-6334 Fax: (314) 576-1664
Internet: http://www.biomedsys.com
E-mail: info@biomedsys.com

Biomedical Systems SA/NV [398085]


1945 Chausse de Wavre
Bruxelles B-1160
Belgium
Phone: 32 (2) 6612070 Fax: 32 (2) 6612071
Internet: http://www.biomedsys.com
E-mail: info@biomedsys.com

CARDIAC SCIENCE
Cardiac Science Corp [451247]
3303 Monte Villa Pkwy
Bothell, WA 98021
Phone: (425) 402-2000, (800) 426-0337 Fax: (425) 402-2001
Internet: http://www.cardiacscience.com
E-mail: info@cardiacscience.com

Cardiac Science Corp China [451278]


6/Fl 829 Yi Shen Road
Shanghai 200233
People's Republic of China
Phone: 86 (21) 64959112 Fax: 86 (21) 64959114
Internet: http://www.cardiacscience.com

CARDIONETICS
Cardionetics Ltd [357301]
Grenville Place
Bracknell RG12 1BP
England
Phone: 44 (1344) 392773 Fax: 44 (1344) 392775
Internet: http://www.cardionetics.com
E-mail: enq@cardionetics.com

CUSTO MED
Custo Med GmbH [284600]
Leibnizstrasse 7
Muenchen/Ottobrunn D-85521
Germany
Phone: 49 (89) 7109800 Fax: 49 (89) 7109810
Internet: http://www.customed.de
E-mail: info@customed.de

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Recorders, Electrocardiography; Scanners, ECG

ELA/SORIN GROUP
Sorin Group Deutschland A Sorin Group Co [453102]
Lindberghstrasse 25
Muenchen D-80939
Germany
Phone: 49 (89) 323010 Fax: 49 (89) 32301391
Internet: http://www.sorin-crm.com
E-mail: info@sorin-crm.com

ELA Medical Inc A Sorin Group Co [103749]


14401 W 65th Way
Arvada, CO 80004-3599
Phone: (303) 425-5508, (800) 352-6466 Fax: (303) 467-6525, (888) 352-3999
Internet: http://www.sorin-crm.com
E-mail: info@sorin-crm.com

Sorin Biomedica Japan KK A Sorin Group Co [417261]


Akasaka Sanno Square Building 8/Fl 2-2-2 Akasaka Minato-ku
Tokyo 107-0052
Japan
Phone: 81 (3) 35608250
Internet: http://www.sorin-crm.com
E-mail: info@sorin-crm.com

ET MEDICAL DEVICES
et medical devices SpA [416216]
strada Rivoltana Nuova 53
Vignate (MI) I-20060
Italy
Phone: 39 (02) 9505181 Fax: 39 (02) 9566013
Internet: http://www.cardiette.biz
E-mail: cardiette@etmed.biz

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
E-mail: info@galix-gbi.com

GBI International Corp [176264]


Rocamora 4029
Capital Federal C1184ABA
Argentina
Phone: 54 (11) 48639309 Fax: 54 (11) 48631753
Internet: http://www.galix-gbi.com
E-mail: info@galix-gbi.com

GE HEALTHCARE
GE Healthcare Europe [171319]
283 rue de la Miniere boite postale 34
Buc Cedex F-78533

8 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

France
Phone: 33 (1) 30704040 Fax: 33 (1) 30709855
Internet: http://www.gehealthcare.com

GE Healthcare (Hong Kong) [401905]


Room 1102 11/Fl The Lee Gardens 33 Hysan Road
Causeway Bay
People's Republic of China
Phone: 852 21006300 Fax: 852 27831878
Internet: http://www.gehealthcare.com

GE Healthcare Technologies Information Technologies Div [441471]


8200 Tower Ave
Milwaukee, WI 53223
Phone: (262) 293-7368, (800) 851-6525 Fax: (262) 293-0122
Internet: http://www.gemedical.com
E-mail: info@gemedsystems.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

GETEMED
getemed Medizin und Informationtechnik AG [382201]
Oderstrasse 77
Teltow D-14513
Germany
Phone: 49 (3328) 39420 Fax: 49 (3328) 394299
Internet: http://www.getemed.de
E-mail: info@getemed.de

MEDITECH
Meditech Ltd [277797]
Ulloi utca 2000
Budapest H-1191
Hungary
Phone: 36 (1) 2808232 Fax: 36 (1) 2829388
Internet: http://www.meditech.eu
E-mail: meditech@meditech.eu

MEDSET
Medset Medizintechnik GmbH [282500]
Postfach 800103
Hamburg D-21001
Germany
Phone: 49 (40) 7258220 Fax: 49 (40) 72582211
Internet: http://www.medset.com
E-mail: info@medset.com

MIDMARK DIAGNOSTICS GROUP (BRENTWOOD)


Midmark Diagnostics Group Div Midmark Corp [416480]

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Recorders, Electrocardiography; Scanners, ECG

1125 W 125th St
Gardena, CA 90248
Phone: (310) 516-6050, (800) 624-8950
Internet: http://www.midmark.com
E-mail: info@midmarkdiagnostics.com

MORTARA INSTRUMENT
Mortara Instrument Inc [104961]
7865 N 86th St
Milwaukee, WI 53224-3431
Phone: (414) 354-1600, (800) 231-7437 Fax: (414) 354-4760
Internet: http://www.mortara.com
E-mail: sales@mortara.com

Mortara Instrument bv [426610]


H Dunantplein 6
de Bilt NL-3731 CL
The Netherlands
Phone: 31 (30) 2205050 Fax: 31 (30) 2201531
Internet: http://www.mortara.com
E-mail: solutions@mortara.com

Mortara Instrument GmbH [281445]


Henricistrasse 124
Essen D-45136
Germany
Phone: 49 (201) 268311 Fax: 49 (201) 268313
Internet: http://www.mortara.com
E-mail: solutions@mortara.com

Mortara Rangoni Europe srl [157063]


via Cimarosa 103-105
Casalecchio (BO) I-40033
Italy
Phone: 39 (051) 2987811 Fax: 39 (051) 6133582
Internet: http://www.mortara.it
E-mail: centralino@mortara.it

NASIFF
Nasiff Assoc Inc [328673]
PO Box 88
Brewerton, NY 13029
Phone: (315) 676-2346, (866) 627-4332 Fax: (315) 676-4711
Internet: http://www.nasiff.com
E-mail: nasales@nasiff.com

NORAV MEDICAL
Norav Medical Ltd [227936]
2 Hamada St
Yokneam IL-200692
Israel
Phone: 972 (4) 9893001 Fax: 972 (4) 9893004
Internet: http://www.norav.com
E-mail: sales@norav.com

10 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

NOVACOR
Novacor [160260]
4 passage Saint Antoine
Rueil-Malmaison Cedex F-92500
France
Phone: 33 (1) 41390161 Fax: 33 (1) 41390199
Internet: http://www.novacor.com
E-mail: novacor@novacor.fr

PHILIPS MEDICAL SYSTEMS


Philips Healthcare Cardiac & Monitoring Systems Div [453548]
3000 Minuteman Rd Mailstop 101
Andover, MA 01810
Phone: (978) 659-3000, (800) 934-7372, (800) 947-3299
Internet: http://www.medical.philips.com

Philips Healthcare International bv [453549]


Veenpluis 4-6 Postbus 10000
Best NL-5680 DA
The Netherlands
Phone: 31 (40) 2763051
Internet: http://www.medical.philips.com

PROGETTI
Progetti srl [272310]
via Bruno Buozzi 28
Moncalieri (TO) I-10024
Italy
Phone: 39 (011) 644738 Fax: 39 (011) 645822
Internet: http://www.progettimedical.com
E-mail: info@progettimedical.com

SCHILLER
Schiller America Inc [108674]
2131 NW 79th Ave
Doral, FL 33122
Phone: (786) 845-0620, (888) 845-8455 Fax: (786) 845-0602
Internet: http://www.schilleramerica.com
E-mail: sales@schilleramerica.com

Schiller AG [162079]
Altgasse 68
Baar CH-6341
Switzerland
Phone: 41 (41) 7664242 Fax: 41 (41) 7610880
Internet: http://www.schiller.ch
E-mail: sales@schiller.ch

Schiller Asia Pacific [330130]


7 Jalan Ara SD 7/3B Bandar Sri Damansara
Kuala Lumpur 52200
Malaysia
Phone: 60 (3) 62723033 Fax: 60 (3) 62722030

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Recorders, Electrocardiography; Scanners, ECG

Internet: http://www.schiller-asia.com
E-mail: sales@schiller.com.my

SCOTTCARE
Rozinn Electronics Inc A ScottCare Corp Co [106903]
71-22 Myrtle Ave
Glendale, NY 11385-7254
Phone: (718) 386-5526, (800) 648-8840 Fax: (718) 366-4574
Internet: http://www.rozinn.com
E-mail: holter@rozinn.com

SHL TELEMEDICINE
SHL Telemedicine International Ltd [354298]
Ashdar Building 90 Yigal Alon Street
Tel Aviv IL-67891
Israel
Phone: 972 (3) 5612212 Fax: 972 (3) 6242414
Internet: http://www.shl-telemedicine.com
E-mail: shl@shl-telemedicine.com

SPACELABS HEALTHCARE
Spacelabs Healthcare GmbH AN OSI Systems Co [452748]
Schwabacher Strasse 34
Feucht D-90537
Germany
Phone: 49 (9128) 9160 Fax: 49 (9128) 916127
Internet: http://www.spacelabshealthcare.com
E-mail: suggestions@spacelabs.com

Spacelabs Healthcare Inc An OSI Systems Co [101758]


5150 220th Ave SE
Issaquah, WA 98029
Phone: (425) 657-7200, (800) 522-7025 Fax: (425) 657-7212
Internet: http://www.spacelabshealthcare.com
E-mail: suggestions@spacelabs.com

Spacelabs Healthcare Ltd An OSI Systems Co [452741]


1 Harforde Court John Tate Road
Hertford SG13 7NW
England
Phone: 44 (1992) 507700 Fax: 44 (1992) 501213
Internet: http://www.spacelabshealthcare.com
E-mail: uksales@spacelabs.com

SUZUKEN
Suzuken Co Ltd [158015]
8 Higashi Kataha-cho Higashi-ku
Nagoya-shi 461-8701
Japan
Phone: 81 (52) 9506327 Fax: 81 (52) 9627440
Internet: http://www.suzuken.co.jp
E-mail: kenz@suzuken.co.jp

12 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

UBS INSTRUMENTS
UBS Instruments Corp Medical Equipment Div [402849]
7210 Jordan Ave B-10
Canoga Park, CA 91303
Phone: (818) 710-1195 Fax: (818) 710-1242
E-mail: hklee4@hotmail.com

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 hpcs@ecri.org (e-mail).

Last updated December 2008

©2010 ECRI Institute. All Rights Reserved. 13


Recorders, Electrocardiography; Scanners, ECG

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 Institute’s Problem Reporting System. While these data are reviewed by qualified
health professionals, they have not been tested by ECRI Institute’s 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 product’s 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, finder’s 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 more than
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 Institute’s 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.

14 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Product Comparison Charts

©2010 ECRI Institute. All Rights Reserved. 15


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ECRI INSTITUTE'S ADVANCED BIOSENSOR ADVANCED BIOSENSOR ADVANCED BIOSENSOR


RECOMMENDED
SPECIFICATIONS1
Basic Holter Recorders AB180 AB180R DL700
WHERE MARKETED Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes
CE MARK (MDD) Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Retrospective, real-time, or Digital Digital Digital
combination
RECORDER
ANNOTATION
Entry of patient ID, Keypad Keypad Diary
method
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection For real-time systems only No No No
Pacemaker detection Yes Yes Yes
RECORDER
Type Direct, digital, tape, or Digital Digital Digital
analog
No. of patient lead wires 7 7 7
Modes (can record 3 or No No No
12 leads with same
recorder)
Medium Any CompactFlash CompactFlash PCMCIA Flash
Capacity, hr 24 24 24 or 48 or 72 24 or 48
Memory size, MB 64 256 32
Frequency resp, Hz 0.67-40 0.05-50 0.05-60 0.05-100
Sampling rate, 180 180 133
samples/sec
Resolution, bits 10 10 8
Gain/sensitivity, mm/mV 2X 2X 2X
Calibration signal For analog media (cassette Yes Yes Yes
tape)
Signal output jack Optional No No Yes
Real-time clock (for Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 3 3 3
Others Not specified None Not specified
Every beat Yes Yes Yes
Length of time, hr 1-24 1-72 1-48
TIME DISPLAYED Optional Yes Yes Yes
FULL DISCLOSURE Preferred Yes Yes Yes
Length of time, hr 24 1-24 1-72 1-48

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

16 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ECRI INSTITUTE'S ADVANCED BIOSENSOR ADVANCED BIOSENSOR ADVANCED BIOSENSOR


RECOMMENDED
SPECIFICATIONS1
Basic Holter Recorders AB180 AB180R DL700
DATA COMPRESSION No No No
Type NA NA NA
Compression ratio NA NA NA
SOFTWARE Not specified Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) Any standard type AA (2) AA (1) AA (2)
Rechargeable Optional Optional Optional Optional
Recharging time, hr <16 Depends on charger Depends on charger Depends on charger
purchased purchased purchased
Operating time, hr 24 24 72 48
Low-battery notice Yes Yes Yes No
OTHER COMPATIBLE None None None
SCANNERS
H x W x D, cm (in) 7.1 x 11.2 x 2 (2.8 x 4.4 x 7.1 x 9.7 x 2 (2.8 x 3.8 x 15.2 x 8.9 x 3 (6 x 3.5 x 1.2)
0.8) 0.8)
WEIGHT, g (oz) 141 (5) 112 (4) 340.2 (12)
PURCHASE
INFORMATION
List price $2,495 $2,495 $1,495
Warranty 1 year 1 year 1 year
Delivery time, ARO Next day Next day Next day
Year first sold 1999 2004 1996
Number installed, 200/400 400/800 2,000/5,000
USA/worldwide
Fiscal year July to June July to June July to June
GREEN FEATURES None specified None specified None specified
OTHER SPECIFICATIONS Real-time ECG display. Real-time ECG display. Test jacks.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2007 December 2007 December 2007
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

©2010 ECRI Institute. All Rights Reserved. 17


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ADVANCED BIOSENSOR ADVANCED BIOSENSOR AEROTEL AEROTEL


DM400 MS2000 Heart 2005A Heart 2006
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified, single-lead Not specified, dual-lead loop
loop event recorder event recorder
TYPE Analog Digital Loop event recorder Loop event recorder
RECORDER
ANNOTATION
Entry of patient ID, Diary Keypad No No
method
Patient (event marker) Yes Yes Yes Yes
Time No Yes No No
Arrhythmia detection No No Yes Yes
Pacemaker detection Yes Yes Not guaranteed Not guaranteed
RECORDER
Type Analog Digital Direct Direct
No. of patient lead wires 5 or 7 7 3 4
Modes (can record 3 or No No No No
12 leads with same
recorder)
Medium Cassette tape CompactFlash Solid-state Solid-state
Capacity, hr 24 or 48 24 or 48 240 sec 480 sec
Memory size, MB NA 64 240 sec 480 sec
Frequency resp, Hz 0.05-100 0.05-100 0.05-40 0.05-40
Sampling rate, 128 133 250 250
samples/sec
Resolution, bits 8 8 LSB 25 µV LSB 25 µV
Gain/sensitivity, mm/mV 2X 2X Not specified Not specified
Calibration signal Yes Yes Yes Yes
Signal output jack Yes No No No
Real-time clock (for No Yes No No
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 or 3 3 1 2
Others Not specified Not specified Patient event recorder Patient event recorder
Every beat Yes Yes Not specified Not specified
Length of time, hr 1-48 1-48 Not specified Not specified
TIME DISPLAYED Yes Yes No No
FULL DISCLOSURE Yes Yes Not specified Not specified
Length of time, hr 1-48 1-48 Not specified Not specified

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

18 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ADVANCED BIOSENSOR ADVANCED BIOSENSOR AEROTEL AEROTEL


DM400 MS2000 Heart 2005A Heart 2006
DATA COMPRESSION No No Not specified Not specified
Type NA NA Not specified Not specified
Compression ratio NA NA Not specified Not specified
SOFTWARE Not specified Not specified Yes (factory) Yes (factory)
UPGRADEABLE
BATTERY
Type (number) 9 V alkaline (not specified) AA (2) 1.5 V AA alkaline (not 1.5 V AA alkaline (not
specified) specified)
Rechargeable Optional Optional No No
Recharging time, hr Depends on charger Depends on charger NA NA
purchased purchased
Operating time, hr 48 48 720 720
Low-battery notice No Yes Yes Yes
OTHER COMPATIBLE None None Not specified Not specified
SCANNERS
H x W x D, cm (in) 15.2 x 8.9 x 3 (6 x 3.5 x 1.2) 7.1 x 11.2 x 2 (2.8 x 4.4 x 7.5 x 6.8 x 1.7 (3 x 2.7 x 7.5 x 6.8 x 1.7 (3 x 2.7 x
0.8) 0.7) 0.7)
WEIGHT, g (oz) 340.2 (12) 141 (5) 80 (2.8) with battery 80 (2.8) with battery
PURCHASE
INFORMATION
List price $1,295 $2,495 Not specified Not specified
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO Next day Next day Stock to 90 days Stock to 90 days
Year first sold 1996 1996 Not specified Not specified
Number installed, 3,000/8,000 500/900 Not specified Not specified
USA/worldwide
Fiscal year July to June July to June January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Test jacks. Real-time ECG display. Transtelephonic ECG Transtelephonic ECG
transmission to Aerotel transmission to Aerotel
receiving stations. receiving stations.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2007 December 2007 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 19


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL AEROTEL AEROTEL AEROTEL APPLIED CARDIAC


HeartOne HeartView HeartView P-12/8 Plus Holter Performer Model
2003 & 2005 Digital
Recorders
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified, postevent Not specified Not specified Not specified
TYPE Postevent recorder Postevent recorder Postevent recorder Digital
RECORDER
ANNOTATION
Entry of patient ID, No No No Not specified
method
Patient (event marker) Yes Yes Yes Yes
Time No No No Yes
Arrhythmia detection Yes Yes Yes No
Pacemaker detection Not guaranteed Not guaranteed Not guaranteed Records actual pacer
artifact
RECORDER
Type Direct Direct Direct Digital
No. of patient lead wires None (embedded electrode) 10 3, plus 4 embedded 5 or 7
electrodes
Modes (can record 3 or No No 8 or 12 leads selectable Not specified
12 leads with same
recorder)
Medium Solid-state Solid-state Solid-state ATA
Capacity, hr 120 sec 58 sec 40 sec Up to 120
Memory size, MB 120 sec 58 sec 40 sec Up to 1 GB
Frequency resp, Hz 0.5-30 0.05-150 0.05-150 0.05-1,000
Sampling rate, 136 375 375 4,480 continuous
samples/sec
Resolution, bits LSB 19.5 µV LSB 39 µV LSB 39 µV 8
Gain/sensitivity, mm/mV Not specified Not specified Not specified Not specified
Calibration signal Yes Yes Yes 1 MV
Signal output jack No Acoustic, RS232 Acoustic, digital Yes
Real-time clock (for No No No Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 1 12 8 or 12 2 or 3
Others Patient event recorder Patient event recorder Patient event recorder None
Every beat Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified
TIME DISPLAYED No No No Yes
FULL DISCLOSURE Not specified Not specified Not specified See scanner
Length of time, hr Not specified Not specified Not specified See scanner

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

20 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL AEROTEL AEROTEL AEROTEL APPLIED CARDIAC


HeartOne HeartView HeartView P-12/8 Plus Holter Performer Model
2003 & 2005 Digital
Recorders
DATA COMPRESSION Not specified Not specified Not specified Not specified
Type Not specified Not specified Not specified Not specified
Compression ratio Not specified Not specified Not specified Not specified
SOFTWARE Yes (factory) Yes (factory) Yes (factory) See scanner
UPGRADEABLE
BATTERY
Type (number) 1.5 V AAA (not specified) 9 V alkaline (not specified) 9 V alkaline (not specified) AA or AA lithium (not
specified)
Rechargeable No No No Optional
Recharging time, hr NA NA NA Not specified
Operating time, hr Not specified 500 500 48, 120
(recording/transmission) (recording/transmission)
Low-battery notice Yes Yes Yes Not specified
OTHER COMPATIBLE Not specified Not specified Not specified NA
SCANNERS
H x W x D, cm (in) 6.3 x 6.3 x 1.3 (2.5 x 2.5 x 12 x 6 x 2.5 (4.7 x 2.4 x 1) 11 x 6 x 3.4 (4.3 x 2.4 x 1.3) 5.1 x 7.6 x 1.3 (2.1 x 3.9 x
0.5) 0.6)
WEIGHT, g (oz) 60 (2.1) with battery 110 (3.9) with battery, 180 142 (5) with battery 48 (1.7)
(6.3) without battery
PURCHASE
INFORMATION
List price Not specified Not specified Not specified Not specified
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO Stock to 90 days Stock to 90 days Stock to 90 days 7 days (guaranteed)
Year first sold Not specified Not specified Not specified Not specified
Number installed, Not specified Not specified Not specified Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Transtelephonic ECG Transtelephonic Transtelephonic ECG Ultrahigh-resolution
transmission to Aerotel transmission; digital output. transmission to Aerotel recording of actual pacer
receiving stations. receiving stations. artifacts; real-time review of
ECG on LCD screen to
ensure optimum hookup
quality; self-diagnostics; 48
hr service turnaround. UL-
approved safety leads.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 May 2006
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 21


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL APPLIED CARDIAC ASPEL ASPEL BIOMEDICAL SYSTEMS


Holter Performer Model AsPEKT 702 AsPEKT 812 BMS 1200
9900 Cassette
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes No No Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Tape Real-time Real-time Continuous
RECORDER
ANNOTATION
Entry of patient ID, Not specified Not specified Not specified Keypad or via PC
method
Patient (event marker) Yes Yes Yes Yes
Time No Yes Yes Yes
Arrhythmia detection No Yes Yes No
Pacemaker detection Not specified Not specified Not specified Yes
RECORDER
Type Tape Digital Digital Digital
No. of patient lead wires 5 or 7 7 10 5, 7, or 10
Modes (can record 3 or Not specified Not specified Not specified 3 or 12 leads
12 leads with same
recorder)
Medium Cassette Flash card Flash card CompactFlash card
Capacity, hr 24-48 24 48 24 or 48
Memory size, MB Not specified Not specified Not specified Up to 2 GB
Frequency resp, Hz 0.05-1,000 0.05-80 0.05-80 0.5-60
Sampling rate, Not specified Not specified Not specified 128-1,024
samples/sec
Resolution, bits Not specified Not specified Not specified 8, 10, or 12
Gain/sensitivity, mm/mV Not specified Not specified Not specified Not specified
Calibration signal 1 MV Yes Yes Yes
Signal output jack Yes Yes Yes ECG displayed on LCD
Real-time clock (for Not specified Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 or 3 3 12 3 or 12
Others Timing track Patient event Patient event Not specified
Every beat Not specified Not specified Not specified Yes
Length of time, hr Not specified Not specified Not specified Not specified
TIME DISPLAYED Yes No Yes Yes
FULL DISCLOSURE Not specified Not specified Not specified Yes
Length of time, hr Not specified Not specified Not specified 24-48

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

22 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL APPLIED CARDIAC ASPEL ASPEL BIOMEDICAL SYSTEMS


Holter Performer Model AsPEKT 702 AsPEKT 812 BMS 1200
9900 Cassette
DATA COMPRESSION Not specified Not specified Not specified No
Type Not specified Not specified Not specified NA
Compression ratio Not specified Not specified Not specified NA
SOFTWARE Not specified Not specified Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) 9 V (not specified) AA alkaline (1) AA alkaline (2) AA alkaline (1)
Rechargeable Optional Optional Optional Yes
Recharging time, hr Not specified Not specified 48 Not specified
Operating time, hr 48 24 24 Up to 72
Low-battery notice Not specified Not specified Not specified Yes
OTHER COMPATIBLE All 1 mm/sec cassette Not specified Not specified BMS Century Series
SCANNERS systems, high-resolution
playback on ACS systems
H x W x D, cm (in) 8.8 x 15 x 2.8 (3.5 x 5.9 x 7.5 x 7.2 x 2.3 (3 x 2.8 x 13 x 9.6 x 3 (5.1 x 3.8 x 1.2) 7 x 9.5 x 2 (2.8 x 3.8 x 0.8)
1.1) 0.9)
WEIGHT, g (oz) 281 (9.9) 130 (4.6) 250 (8.8) 112 (3.9)
PURCHASE
INFORMATION
List price Not specified €967.60 (US$1,245) €1,272 (US$1,636) Not specified
Warranty 1 year 1 year 1 year 2 years
Delivery time, ARO 7 days (guaranteed) Not specified Not specified 2 weeks
Year first sold Not specified 2002 2004 2007
Number installed, Not specified Not specified Not specified Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Ultrahigh-resolution None specified. None specified. None specified.
recording of actual pacer
artifacts; self-diagnostics;
lead-failure and bad-battery
indicators; 48 hr service
turnaround. UL-approved
safety leads.
UMDNS CODE(S) 16009 18361 18361 18361
LAST UPDATED May 2006 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 23


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS CARDIAC SCIENCE CARDIAC SCIENCE


BMS 300 BMS VX3 Burdick Vision 5L Burdick Vision 5LR
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Adult, pediatric Adult, pediatric
TYPE Continuous Retrospective Digital Digital
RECORDER
ANNOTATION
Entry of patient ID, Keypad or via PC Keypad Front panel on recorder or Front panel on recorder or
method via computer via computer
Patient (event marker) Yes Yes Yes Yes
Time Yes No Yes Yes
Arrhythmia detection No No Yes Yes
Pacemaker detection Yes Yes Yes Yes
RECORDER
Type Digital Digital Digital Digital
No. of patient lead wires 5 or 7 5 or 7 5 or 7 5 or 7
Modes (can record 3 or 3 leads only 3 3 3
12 leads with same
recorder)
Medium Secure digital card CompactFlash card Preprogrammed Preprogrammed
CompactFlash card CompactFlash card
Capacity, hr 24, 48, and 72 24-48 24 or 48 1, 4, 8, 12, 16, 20, 24, user
selectable
Memory size, MB Up to 2 GB 256 128 1 GB
Frequency resp, Hz 0.5-50 0.5-50 0.05-60 0.05-300
Sampling rate, 128, 256, 512, 1,024 133 200 1,000
samples/sec
Resolution, bits 10 8 8-10, 4X oversample 8-10, 4X oversample
Gain/sensitivity, mm/mV Not specified Not specified User-selectable User-selectable
Calibration signal Yes Yes NA NA
Signal output jack ECG displayed on LCD ECG displayed on LCD NA NA
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 2 or 3 2 or 3 2 or 3
Others None specified Not specified None specified None specified
Every beat Yes Yes Yes Yes
Length of time, hr Not specified Not specified 24 or 48 1, 4, 8, 12, 16, 20, 24, user
selectable
TIME DISPLAYED Yes Yes Yes Yes
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr 24-72 24-48 Length of recording Length of recording

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

24 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS CARDIAC SCIENCE CARDIAC SCIENCE


BMS 300 BMS VX3 Burdick Vision 5L Burdick Vision 5LR
DATA COMPRESSION No No No No
Type NA NA NA NA
Compression ratio NA NA NA NA
SOFTWARE Not specified Not specified Yes Yes
UPGRADEABLE
BATTERY
Type (number) AA alkaline (1) 1.5 V AA alkaline (2) AA alkaline (1) AA alkaline (1)
Rechargeable Yes Yes No No
Recharging time, hr Not specified Not specified NA NA
Operating time, hr Up to 48 Up to 48 24 or 48 1, 4, 8, 12, 16, 20, 24, user
selectable
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE BMS Century Series BMS Century Series None None
SCANNERS
H x W x D, cm (in) 8.8 x 6.6 (3.5 x 2.6) 11.3 x 7 x 2.6 (4.4 x 2.8 x 1) 9.5 x 7.6 x 2.3 (3.8 x 3 x 9.5 x 7.6 x 2.3 (3.8 x 3 x
0.9) 0.9)
WEIGHT, g (oz) 114 (4) 114 (4) 114 (4) 114 (4)
PURCHASE
INFORMATION
List price Not specified Not specified $1,995 $2,250
Warranty 2 years 2 years 1 year 1 year
Delivery time, ARO 2 weeks 2 weeks 2-3 weeks 2-3 weeks
Year first sold 2007 2001 Not specified Not specified
Number installed, Not specified Not specified Not specified Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS None specified. None specified. Live ECG display for patient Live ECG display for patient
hookup verification. hookup verification; requires
research mode option on
scanning software (Vision or
Vision Premier).
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 25


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL CARDIONETICS CUSTO MED CUSTO MED CUSTO MED


C.Net2000+ : C.Net2100 : Custo cor Custo Flash 110 Custo Flash 220
C.Net5000
WHERE MARKETED Worldwide, except USA : Worldwide Worldwide Worldwide
USA : Not specified
FDA CLEARANCE Yes No No No
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified No usage restriction No usage restriction No usage restriction
TYPE Real-time Real-time Real-time Real-time
RECORDER
ANNOTATION
Entry of patient ID, Unique test reference and Software custo diagnostic Software custo diagnostic Software custo diagnostic
method manual entry of patient (medical operating system) (medical operating system) (medical operating system)
details
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes, plus ventricular Yes Yes Yes
rhythms, tachycardia,
bradycardia, ST
Pacemaker detection No Yes Yes Yes
RECORDER
Type Digital Solid-state memory Solid-state memory Solid-state memory
No. of patient lead wires 3 3, 6, 10 5 5
Modes (can record 3 or Single mode 3, 6, 10 5 5
12 leads with same
recorder)
Medium Solid-state memory Mini SD SD SD
Capacity, hr 24 48 (2 x 24) 24 24
Memory size, MB Not specified 128 minimum 128 minimum 128 minimum
Frequency resp, Hz 0.1-23 0.01-100 0.01-100 0.01-100
Sampling rate, 100, 500 1,000 1,000 1,000
samples/sec
Resolution, bits 12 Not specified Not specified Not specified
Gain/sensitivity, mm/mV 1,000 Not specified Not specified Not specified
Calibration signal Built-in Yes Yes Yes
Signal output jack No No Yes Yes
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 1 Up to 3/6/12 Up to 2 Up to 3
Others None Automatic baseline, auto Automatic baseline, auto Automatic baseline, auto
gain control gain control gain control
Every beat Yes, abnormalities recorded Yes Yes Yes
Length of time, hr 1 48 (24 hr x 7 days) 24 24
TIME DISPLAYED Yes Yes No No
FULL DISCLOSURE No Yes Yes Yes
Length of time, hr NA 48 (24 hr x 7 days) 24 24

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

26 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL CARDIONETICS CUSTO MED CUSTO MED CUSTO MED


C.Net2000+ : C.Net2100 : Custo cor Custo Flash 110 Custo Flash 220
C.Net5000
DATA COMPRESSION No Yes Yes Yes
Type NA Own patented method Own patented method Own patented method
Compression ratio NA Own patented method Own patented method Own patented method
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) AA alkaline (2 or 4) 1.5 V AAA (2) 1.5 V AA (2) 1.5 V AA (2)
Rechargeable Yes Yes Yes Yes
Recharging time, hr Not specified Depends on batteries Depends on batteries Depends on batteries
Operating time, hr 24 monitoring, plus 48 data 72 72 72
retention
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE Monitor delivers fully No No No
SCANNERS analyzed report direct to
printer or PC for e-mail,
electronic health record
H x W x D, cm (in) 11.5 x 9.8 x 2.8 (4.5 x 3.9 x 7.6 x 5.5 x 1.5 (3.0 x 2.2 x 9.8 x 6.5 x 2.2 (3.9 x 2.6 x 9.8 x 6.5 x 2.2 (3.9 x 2.6 x
1.1) 0.6) 0.9) 0.9)
WEIGHT, g (oz) 255 (9) 80 (2.6) without batteries 110 (3.9) without batteries 110 (3.9) without batteries
PURCHASE
INFORMATION
List price Not specified $2,200 $2,200 $2,200
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO 2 weeks 3-4 weeks 3-4 weeks 3-4 weeks
Year first sold 1999 : 2000 : 2006 2008 1992 1992
Number installed, NA/not specified : Not Not specified Not specified Not specified
USA/worldwide specified/NA : Not specified
Fiscal year April to March January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Single-lead 24 hr None specified. None specified. None specified.
ambulatory ECG monitor;
analyzes ECG on beat-by-
beat basis using advanced
neural network technology;
full report available on
completion of test with no
additional analysis time
required; report includes
analysis of arrhythmias,
ectopic events, ST-
segment, and patient-
triggered events; report may
be printed by direct
connection to printer or
viewed by means of the
C.onnect Report Viewing
software; C.Net5000
provides onscreen test
results.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 27


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL CUSTO MED CUSTO MED CUSTO MED ELA/SORIN GROUP


Custo Flash 500 Custo Flash 501 Custo Flash 510 SpiderView
WHERE MARKETED Worldwide Worldwide Worldwide Asia, Australia, Europe,
Japan, North America
FDA CLEARANCE No No No Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE No usage restriction No usage restriction No usage restriction Not specified
TYPE Real-time Real-time Real-time Retrospective, 2-12
channels, 1-4 days
RECORDER
ANNOTATION
Entry of patient ID, Software custo diagnostic Software custo diagnostic Software custo diagnostic LCD and keyboard
method (medical operating system) (medical operating system) (medical operating system)
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes Yes Yes Yes
Pacemaker detection No No Yes Yes
RECORDER
Type Solid-state memory Solid-state memory Solid-state memory MMC/SD card
No. of patient lead wires 3 (firmly installed) 3 (firmly installed) 3 (firmly installed) 3-10 different cables
available
Modes (can record 3 or 3 3 3 2-12 leads
12 leads with same
recorder)
Medium SD SD SD MMC/SD card (≥128 MB)
Capacity, hr 168 (7 x 24) 168 (7 x 24) 168 (7 x 24) 96
Memory size, MB 128 minimum 128 minimum 128 minimum 128 or more
Frequency resp, Hz 0.01-100 0.01-100 0.01-100 0.05-70 (0.01-400 in HR
mode)
Sampling rate, Not specified Not specified Not specified 200 or 1,000 Hz
samples/sec
Resolution, bits Not specified Not specified Not specified 2.5 or 10 µV
Gain/sensitivity, mm/mV Not specified Not specified Not specified 0.25-4
Calibration signal Yes Yes Yes Yes
Signal output jack No No No No (LCD display)
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG Up to 3 (I;II;III by Einthoven) Up to 3 (I;II;III by Einthoven) Up to 3 (I;II;III by Einthoven) 2, 3, 9, 12
Others Automatic baseline, auto Automatic baseline, auto Automatic baseline, auto PM pulses, battery level,
gain control gain control gain control ECG display
Every beat Yes Yes Yes Morphology, RR
Length of time, hr 168 (24 hr x 7 days) 168 (24 hr x 7 days) 168 (24 hr x 7 days) Analyzed time
TIME DISPLAYED No No No At hookup
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr 168 (24 hr x 7 days) 168 (24 hr x 7 days) 168 (24 hr x 7 days) 24-96

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

28 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL CUSTO MED CUSTO MED CUSTO MED ELA/SORIN GROUP


Custo Flash 500 Custo Flash 501 Custo Flash 510 SpiderView
DATA COMPRESSION Yes Yes Yes If requested
Type Own patented method Own patented method Own patented method No compression or Zip-like
Compression ratio Own patented method Own patented method Own patented method From 0-4
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) Own rechargeable lithium Own rechargeable lithium Own rechargeable lithium AA alkaline (1)
polymer (not specified) polymer (not specified) polymer (not specified)
Rechargeable Yes Yes Yes Yes
Recharging time, hr 2 2 2 Depends on charger
Operating time, hr 168 (24 hr x 7 days) 168 (24 hr x 7 days) 168 (24 hr x 7 days) Up to 96
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE No No No All ISHNE-compatible
SCANNERS scanners
H x W x D, cm (in) 9.5 x 6.5 x 1,7 (3.7 x 2.6 x 9.5 x 6.5 x 1,7 (3.7 x 2.6 x 9.5 x 6.5 x 1,7 (3.7 x 2.6 x 9.7 x 5.4 x 2.3 (3.8 x 2.1 x
0.7) 0.7) 0.7) 0.9)
WEIGHT, g (oz) 130 (4.2) including batteries 130 (4.2) including batteries 130 (4.2) including batteries 85 (3)
PURCHASE
INFORMATION
List price $2,200 $2,200 $2,200 Not specified
Warranty 1 year 1 year 1 year 2 years
Delivery time, ARO 3-4 weeks 3-4 weeks 3-4 weeks 2 weeks
Year first sold 2007 2007 2007 2003
Number installed, Not specified Not specified Not specified 500/12,000
USA/worldwide
Fiscal year January to December January to December January to December Not specified
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS None specified. None specified. None specified. 1,000 MHz high-resolution
mode; ECG on screen;
patient cable check;
impedance check; PM
protocol.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 29


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ET MEDICAL DEVICES ET MEDICAL DEVICES GALIX GALIX


CARDIOLINE CLICK Holter CARDIOLINE PRIMA Holter GBI-3S GBI-3S-LP
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Not specified Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Adult, pediatric Adult, pediatric
TYPE Retrospective Retrospective Retrospective Retrospective
RECORDER
ANNOTATION
Entry of patient ID, Not specified Not specified PC card driver PC card driver
method
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Not specified Not specified No No
Pacemaker detection Yes Yes Not specified Not specified
RECORDER
Type Digital Digital Digital Digital
No. of patient lead wires 5 or 7 5, 7, or 10 7 7
Modes (can record 3 or 3 3 or 12 3 3
12 leads with same
recorder)
Medium Internal Flash memory Flash card Solid-state standard Solid-state PCMCIA
PCMCIA card memory card
Capacity, hr 24, 48 ≥24 24-48 24-48 ECG mode, 10 m
VHR ECG mode
Memory size, MB 48 Up to 220 64 64
Frequency resp, Hz 0.05-55 0.05-150 0.05-50, 0.05-100 0.05-50/0.05-100 ECG, 0.2-
450 VHR ECG
Sampling rate, 250 Hz/channel Up to 1 kHz/channel 128, 256 128, 256; 1,000 VHR
samples/sec
Resolution, bits 10, 11 µV/bit LSB 12 8 8; 12 VHR
Gain/sensitivity, mm/mV Not specified Not specified 5, 10, 20 5, 10, 20
Calibration signal Not specified Not specified Yes Yes
Signal output jack Yes Yes Yes, through special cable Yes, through special cable
to any monitor or through to any monitor or through a
USB monitor module, which USB monitor module, which
turns the PC display into a turns the PC display into a
cardiac monitor cardiac monitor
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 3-12 (with no compression) 3 3
Others Pacemaker detection, event Pacemaker detection, event None None
marker, battery status, marker, battery status
electrode contact
Every beat Not specified Not specified No No
Length of time, hr Not specified Not specified NA NA
TIME DISPLAYED No Yes Yes Yes
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr Not specified Not specified 24, 48 24, 48

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

30 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL ET MEDICAL DEVICES ET MEDICAL DEVICES GALIX GALIX


CARDIOLINE CLICK Holter CARDIOLINE PRIMA Holter GBI-3S GBI-3S-LP
DATA COMPRESSION Yes None Yes Yes
Type Lossless NA Proprietary Proprietary
Compression ratio 33% average NA Variable, lossless Variable, lossless
SOFTWARE Yes Yes Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) 1.5 V AA (not specified) 3.6 V Ni-MH (not specified) AA alkaline (2) AA alkaline (2)
Rechargeable No Yes Optional Optional
Recharging time, hr NA 1 NA NA
Operating time, hr 48 36 48 48
Low-battery notice Yes Yes Not specified On LCD
OTHER COMPATIBLE None None Galix WinTer Holter Galix WinTer Holter
SCANNERS analyzer analyzer
H x W x D, cm (in) 11 x 8 x 1.7 (4.3 x 3.1 x 0.7) 14.2 x 9.2 x 4.3 (5.6 x 3.6 x 13 x 8 x 2.2 (5.2 x 3.2 x 0.9) 13 x 8 x 2.2 (5.2 x 3.2 x 0.9)
1.7)
WEIGHT, g (oz) 115 (4.1) with battery 320 (11.3) with battery and 210 (7.5) with batteries 210 (7.5) with batteries
flash card
PURCHASE
INFORMATION
List price $2,500 $4,500 Not specified Not specified
Warranty 1 year 1 year 2 years 2 years
Delivery time, ARO 2 weeks 2 weeks 2 days 2 days
Year first sold 2003 1998 1996 1999
Number installed, Not specified 250 3,100 total 1,350 total
USA/worldwide
Fiscal year January to December January to December March to February March to February
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS 3 channels/24-48 hr at 250- 3-12 channels/24 hr without ECG signal stored in a ECG signal stored in a
1,000 Hz sample frequency signal compression; 125- removable PCMCIA card; reusable, removable
for each channel; can be 1,000 Hz sample frequency built-in patient cable tester; PCMCIA card; built-in
connected to PC (via USB for each channel; can be 5- or 7-lead patient cable; patient cable tester; 5- or 7-
port) for inserting patient upgraded with other 128/256 samples/sec per lead patient cable; 12-bit
data, testing ECG signal applications (e.g., stress channel; 12-bit resolution; resolution; security system
quality directly on PC test, rest ECG). low-battery warning on LCD; prevents recording over a
screen, and downloading security system prevents nonprocessed memory
Holter test. recording over a card; records patient data
nonprocessed memory on memory card for
card; records patient data identification; compatible
on memory card for with GALIX Ventricular Late
identification. Potentials analysis software.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 31


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL GALIX GE HEALTHCARE GETEMED GETEMED


GBI-3SM SEER Light (24 hr) : SEER CM 3000 : CM 3000 SM CM 3000-12 : CM 3000-12
Light Extend (48 hr) BT
WHERE MARKETED Worldwide Worldwide Europe; USA by GE Europe; USA by GE
Healthcare Healthcare
FDA CLEARANCE To be submitted Yes Yes Yes
CE MARK (MDD) To be submitted Yes Yes Yes
PATIENT TYPE Adult, pediatric Not specified Adult, pediatric Adult, pediatric
TYPE Retrospective Digital Retrospective Retrospective
RECORDER
ANNOTATION
Entry of patient ID, Yes, not specified PC program or handheld Key panel or via PC Key panel or via PC
method controller
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection No No No No
Pacemaker detection Yes, 12,000 samples/sec for Yes Yes, SM version Yes
atrial and ventricular
pacemaker pulse detection
RECORDER
Type Digital Digital Digital Digital
No. of patient lead wires 7 5 or 7 5 or 7 10
Modes (can record 3 or 3 (true ECG channels) Up to 3 channels No Yes
12 leads with same
recorder)
Medium Solid-state secure digital Integrated memory Flash card Flash card
memory card
Capacity, hr 24, 48, 72 with 1 AAA 24 or 48 24-240 24-72
alkaline battery
Memory size, MB 512 to 1 GB SD memory 32 or 64 Up to 1 GB Up to 1 GB
card
Frequency resp, Hz 0.05-100 ECG, 0.05-500 0.05-40 0.05-75 0.05-150
VHR ECG
Sampling rate, 256-1,000 125 Up to 1.024 1.024
samples/sec
Resolution, bits 16 20 12 12
Gain/sensitivity, mm/mV 5, 10, 20 Not specified 1 1
Calibration signal Yes Digital No No
Signal output jack NA (the recorder has its Yes (infrared) Yes, digital Yes
own graphic display to show
sequentially all 3 ECG
channels)
Real-time clock (for Yes No Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 2 or 3 2 or 3 12
Others None ECG pacemaker Thorax impedance No
Every beat No Yes Yes Yes
Length of time, hr NA 24 or 48 24-240 24-72
TIME DISPLAYED Yes, does not need to be No Yes Yes
adjusted for years
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr 24, 48, 72 24 or 48 24-240 24-72

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covering the above
model(s). These
specifications continue onto
the next page.

32 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL GALIX GE HEALTHCARE GETEMED GETEMED


GBI-3SM SEER Light (24 hr) : SEER CM 3000 : CM 3000 SM CM 3000-12 : CM 3000-12
Light Extend (48 hr) BT
DATA COMPRESSION Not necessary Yes Yes Yes
Type NA Lossless Proprietary Proprietary
Compression ratio NA Not specified 50% 50%
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) AAA alkaline (1) AAA (2) AA alkaline (not specified) AA alkaline (not specified)
Rechargeable Optional No Yes, external Yes, external
Recharging time, hr NA NA 12 12
Operating time, hr 72 Up to 48 120 72
Low-battery notice Yes, through graphic display Yes Yes Yes
message
OTHER COMPATIBLE Galix WinTer Holter SEER Light only: MARS None specified None specified
SCANNERS analyzer 3000, MARS 5000, MARS
8000; All SEER models:
MARS PC, MARS V7.X
H x W x D, cm (in) 7.6 x 5.7 x 1.6 (3 x 2.2 x 5.4 x 8.5 x 1.5 (2.1 x 3.3 x 10.8 x 7.9 x 2.2 (4.3 x 3.1 x 10.8 x 8.6 x 2.2 (4.3 x 3.4 x
0.65) 0.6) 0.9) 0.9)
WEIGHT, g (oz) 55 (1.9) with battery 72 (2.5) 160 (5.6) 160 (5.6)
PURCHASE
INFORMATION
List price Not specified Not specified €3,000-4,000 (US$3,840- €5,000-5,500 (US$6,400-
5,120) 7,040)
Warranty 2 years 1 year 1 year 1 year
Delivery time, ARO 3-5 days 30 days 2 weeks 2 weeks
Year first sold 2007 2001 2000 2004
Number installed, 100 >15,000 total 500/4,500 100/200
USA/worldwide
Fiscal year March to February January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS RoHS compliant. Offers 2-3 channels; small, Graphic display; pacemaker Graphic display; open lead
lightweight; works with pulse detection; open lead detection.
SEER Light controller or PC detection; integrated
program for patient impedance monitoring.
demographic download and
hookup ECG QC. Meets
requirements of AAMI EC-
11, IEC 601-1, ISO 9001,
and UL 544.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 33


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MEDITECH MEDITECH MEDITECH MEDITECH


card(x)plore CardioBlue CardioClip CardioMera
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE No No No No
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Retrospective Prepost Prepost (event recorder) Retrospective
RECORDER
ANNOTATION
Entry of patient ID, Yes Yes Yes Yes
method
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes In software In software Yes
Pacemaker detection Yes Not specified Yes Yes
RECORDER
Type Direct Not specified Not specified Direct
No. of patient lead wires 7 7 7 7
Modes (can record 3 or Not specified Not specified Not specified Not specified
12 leads with same
recorder)
Medium Solid-state memory Solid-state memory Solid-state memory Solid-state memory
Capacity, hr Not specified 1 maximum 1 maximum Not specified
Memory size, MB Not specified 2 2 Not specified
Frequency resp, Hz 0.05-40 0.05-100 0.05-100 0.05-40
Sampling rate, Not specified 150-600 Hz 150-600 Hz Not specified
samples/sec
Resolution, bits Not specified 12 12 Not specified
Gain/sensitivity, mm/mV Not specified Not specified Not specified Not specified
Calibration signal On PC Not necessary Not necessary On PC
Signal output jack Optional cable to RS232 Bluetooth Optical cable to RS232 Optional cable to RS232
Real-time clock (for Not specified Yes Yes Not specified
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 1-5 1-5 3
Others Blood pressure Bluetooth, modem, mobile Optional data transmission Blood pressure
phone by modem
Every beat Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified
TIME DISPLAYED Yes Yes Yes Yes
FULL DISCLOSURE Yes No No Yes
Length of time, hr Not specified NA NA Not specified

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

34 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MEDITECH MEDITECH MEDITECH MEDITECH


card(x)plore CardioBlue CardioClip CardioMera
DATA COMPRESSION Not specified Yes (without data loss) Yes (without data loss) Not specified
Type Not specified Not specified Not specified Not specified
Compression ratio Not specified Not specified Not specified Not specified
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) Not specified AAA (1) AAA (1) Not specified
Rechargeable Not specified No No Not specified
Recharging time, hr Not specified NA NA Not specified
Operating time, hr Not specified 1 month 1 month Not specified
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE None specified None specified None specified None specified
SCANNERS
H x W x D, cm (in) Not specified 6.6 x 5.9 x 1.7 (2.6 x 2.3 x 6.6 x 5.9 x 1.7 (2.6 x 2.3 x Not specified
0.7) 0.7)
WEIGHT, g (oz) Not specified ~49 (1.7) without batteries ~54 (1.9) with batteries Not specified
PURCHASE
INFORMATION
List price Not specified Not specified Not specified Not specified
Warranty 2 years 2 years 2 years 2 years
Delivery time, ARO 2-4 weeks 2-4 weeks 2-4 weeks 2-4 weeks
Year first sold 2004 2005 2003 2004
Number installed, Not specified Not specified Not specified Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Ambulatory cardiovascular Wireless transmission to Solid-state memory with up Windows-based transfer
diagnostic device. compatible devices with to 1 hr of ECG storage and from recorder via card
Bluetooth (mobile phone, 8 min pre-event strip length. reader.
PDA, PC).
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2007 December 2007 December 2007 December 2007
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 35


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MEDITECH MEDSET MIDMARK DIAGNOSTICS MORTARA INSTRUMENT


GROUP (BRENTWOOD)
CardioTens CARDIOLIGHT IQmark Digital Holter H12+
TELESMART H RecorderCF
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE No No Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified No restriction Not specified Adult and pediatric
TYPE Prepost Real-time, retrospective Retrospective, continuous 12-lead digital
RECORDER
ANNOTATION
Entry of patient ID, Yes PC-based No Direct, Holter system, or
method Web program
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection In software No No Yes
Pacemaker detection Not specified Yes Yes Yes
RECORDER
Type Not specified Digital Digital Digital
No. of patient lead wires 5 3, 5, 7 5, optional 7 6 or 10
Modes (can record 3 or Not specified 2 and 3 3 Yes
12 leads with same
recorder)
Medium Solid-state memory CompactFlash card Removable CompactFlash CompactFlash card
card
Capacity, hr 4 maximum (plus 24 hr BP, Up to 168 24 24, 48
ST, and HR monitoring)
Memory size, MB 2 500, 1,000 64-1,024 64, 128
Frequency resp, Hz 0.05-100 0.05-55 0.05-100 0.05-60
Sampling rate, 200 Hz 200 Hz 128 180 per channel
samples/sec
Resolution, bits 12 12 8 20
Gain/sensitivity, mm/mV Not specified Variable NA 10 standard
Calibration signal Not necessary Yes NA Not needed
Signal output jack Optical cable Yes NA Not needed, ECG preview
on display
Real-time clock (for Yes Yes Event time stamp Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 2 or 3 3, noncompressed FD 12, simultaneous acquisition
Others Simultaneous 24 hr BP Patient marker Patient events, pacemaker 10,000
monitoring spikes samples/sec/channel
pacemakers spike
detection, ST-segment
analysis on all 12 leads
Every beat Not specified Yes Yes Yes
Length of time, hr Not specified Variable, up to 168 24 Up to 48
TIME DISPLAYED Yes No Recording duration Yes
FULL DISCLOSURE No Yes Yes Yes
Length of time, hr NA Up to 168 24 Up to 48

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

36 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MEDITECH MEDSET MIDMARK DIAGNOSTICS MORTARA INSTRUMENT


GROUP (BRENTWOOD)
CardioTens CARDIOLIGHT IQmark Digital Holter H12+
TELESMART H RecorderCF
DATA COMPRESSION Yes (without data loss) Lossless No Proprietary
Type Not specified Not specified NA Proprietary
Compression ratio Not specified Variable NA Proprietary
SOFTWARE Yes Yes Not required Yes
UPGRADEABLE
BATTERY
Type (number) AA (4) AA (1), alkaline or lithium AA alkaline (2) 1.5 V AA alkaline or lithium
(1)
Rechargeable Yes Yes Not recommended No
Recharging time, hr 19 4 NA NA
Operating time, hr 48 120 24 Up to 48
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE None specified CARDIOLIGHT software IQmark EZ Holter, IQmark None
SCANNERS Advanced Holter and
IQmark Advanced Holter
with pacemaker
H x W x D, cm (in) 12.4 x 8.2 x 3.3 (4.9 x 3.2 x 12.2 x 6.7 x 2 (4.8 x 2.6 x 11.3 x 7 x 2.6 (4.4 x 2.8 x 1) 6.4 x 9.1 x 2.5 (2.5 x 3.5 x
1.3) 0.79) 1)
WEIGHT, g (oz) ~350 (12.3) with batteries 130 (4.6) 113 (4) 125 (4.4) without battery
PURCHASE
INFORMATION
List price Not specified €2,100 (US$2,832) $1,838 Not specified
Warranty 2 years 1 year 1 year 1 year
Delivery time, ARO 2-4 weeks 2 weeks 24 hr 30 days
Year first sold 1998 2005 2001 2002
Number installed, Not specified 0/800 Not specified Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Automatic event detection Bluetooth interface to check Large LCD shows all Small 12-lead Holter
with adjustable preset limits electrode application; 3-, 5-, channels of live ECG recorder with continuous 12-
(ST, pulse). or 7-lead electrode cable; signals before recording; lead ECG data acquisition;
removable memory card to removable CompactFlash pacemaker detection and
transfer ECG; pacemaker card; 5- or 7-lead patient 12-lead ST-segment
spike detection; self- cable options. ETL listed. display; LCD graphically
formatting. displays all 12 ECG
waveforms and measures
electrode impedance during
patient hookup.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2007 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 37


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MORTARA INSTRUMENT NASIFF NORAV MEDICAL NOVACOR


H3+ H1 DL 900 DUOLTER ACCESS
WHERE MARKETED Worldwide Worldwide Worldwide Africa, Asia/Pacific,
Australia, Europe, Middle
East
FDA CLEARANCE Yes Yes Yes No
CE MARK (MDD) Yes No Yes Yes
PATIENT TYPE Adult and pediatric Not specified Not specified Not specified
TYPE 2- or 3-channel digital Real-time and prospective Retrospective Real-time
RECORDER
ANNOTATION
Entry of patient ID, Direct, Holter system, or Keyboard Key panel Not specified
method Web program
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes Yes Yes No
Pacemaker detection Yes Yes Yes Not specified
RECORDER
Type Digital Digital Digital Digital (removable)
No. of patient lead wires 5 5 or 7 5 Not specified
Modes (can record 3 or 2 or 3 channels Not specified 3 Not specified
12 leads with same
recorder)
Medium Internal memory Flash SD memory card Flash card
Capacity, hr Up to 48 24, 48 24-120 24
Memory size, MB 64 Not specified Up to 1 GB Not specified
Frequency resp, Hz 0.05-60 0.05-100 0.05-60 (-3 dB) 0.05-50
Sampling rate, 180 per channel Not specified 256, 512, 1,024 Not specified
samples/sec
Resolution, bits 12 Not specified 8, 10 Not specified
Gain/sensitivity, mm/mV 10 standard Not specified 0.5X, 1X, 2X Not specified
Calibration signal Not needed Yes Yes No
Signal output jack Not needed, ECG preview Yes Yes, USB or memory card No
on display
Real-time clock (for Yes Yes Yes Not specified
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 or 3, simultaneous 3 2 or 3, differential 2
acquisition
Others Pacemakers spike Patient event Not specified ABPM, patient position and
detection, ST-segment event
analysis on all recorded
channels
Every beat Yes Yes Yes Not specified
Length of time, hr Up to 48 24 or 48 1-120 Not specified
TIME DISPLAYED Yes Yes Yes Yes
FULL DISCLOSURE Yes Yes Yes Not specified
Length of time, hr Up to 48 24 or 48 1, 6, 12, 24, 48, 72, 96, and Not specified
120 (120 requires fresh
lithium battery)

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

38 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL MORTARA INSTRUMENT NASIFF NORAV MEDICAL NOVACOR


H3+ H1 DL 900 DUOLTER ACCESS
DATA COMPRESSION Proprietary No No Not specified
Type Proprietary NA NA Not specified
Compression ratio Proprietary NA NA Not specified
SOFTWARE Yes Yes Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) 1.5 V AAA alkaline (1) AA alkaline (not specified) AA alkaline IEC-LR3 or AAA Ni-MH (not specified)
lithium L92-FR03 (not
specified)
Rechargeable No Yes Optional Yes
Recharging time, hr NA Not specified Depends on charger 2
purchased
Operating time, hr Up to 48 48 Depends on battery 24
Low-battery notice Yes Yes Yes Not specified
OTHER COMPATIBLE None IBM-compatible computers None specified Novacor software
SCANNERS
H x W x D, cm (in) 6.4 x 2.5 x 1.9 (2.5 x 1 x 10 x 5 x 2.4 (4 x 2 x 0.9) 61 x 61 x 17 (2.4 x 2.4 x 6.7 x 10.2 x 3.6 (2.6 x 4 x
0.8) 0.67) 1.4)
WEIGHT, g (oz) 28 (1) without battery 141 (5) with batteries 56 (2) 290 (10.2)
PURCHASE
INFORMATION
List price Not specified $3,195 with 1 recorder, Not specified $4,000-7,000
$1,400 for additional
recorders
Warranty 1 year 2 years and extended 1 year 1 year
Delivery time, ARO 30 days 1 week 30 days 3 weeks
Year first sold 2005 1996 2008 2002
Number installed, Not specified Not specified Not specified NA/25
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Very small Holter recorder None specified. ECG channel displays Oscillometric ABPM.
with continuous 2- or 3- English, German, French,
channel ECG data Italian, Portuguese,
acquisition; 5-wire patient Swedish, Dutch, Finnish,
cable type determines Polish, and Russian.
channels recorded;
pacemaker detection and 2-
or 3-channel ST-segment
display; LCD graphically
displays all ECG waveforms
during patient hookup.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2007 December 2008 May 2006
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 39


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL NOVACOR NOVACOR NOVACOR NOVACOR


Quattrolter Triolter VISTA Access VISTA Plus
WHERE MARKETED Africa, Asia/Pacific, Africa, Asia/Pacific, Africa, Asia/Pacific, Africa, Asia/Pacific,
Australia, Europe, Middle Australia, Europe, Middle Australia, Europe, Middle Australia, Europe, Middle
East East East East
FDA CLEARANCE No No Submitted Submitted
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Real-time Real-time Continuous real-time Continuous real-time
recording recording
RECORDER
ANNOTATION
Entry of patient ID, Not specified Not specified Not specified Not specified
method
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection No No No No
Pacemaker detection Not specified Not specified Not specified Not specified
RECORDER
Type Digital (removable) Digital (removable) Digital (removable) Digital (removable)
No. of patient lead wires Not specified Not specified Not specified Not specified
Modes (can record 3 or Not specified Not specified Not specified Not specified
12 leads with same
recorder)
Medium Flash card Flash card CompactFlash card CompactFlash card
Capacity, hr 24 24 24 264
Memory size, MB Not specified Not specified Not specified Not specified
Frequency resp, Hz 0.05-50 0.05-50 0.05-100 0.05-100
Sampling rate, Not specified Not specified Not specified Not specified
samples/sec
Resolution, bits Not specified Not specified Not specified Not specified
Gain/sensitivity, mm/mV Not specified Not specified Not specified Not specified
Calibration signal No No No No
Signal output jack No No No No
Real-time clock (for Not specified Not specified Not specified Not specified
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 2 2 3 3
Others ABPM, patient ABPM, patient position and Patient event, voice Patient event, voice
position/event/activity event message message
Every beat Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified
TIME DISPLAYED Yes Yes Yes Yes
FULL DISCLOSURE Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

40 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL NOVACOR NOVACOR NOVACOR NOVACOR


Quattrolter Triolter VISTA Access VISTA Plus
DATA COMPRESSION Not specified Not specified Not specified Not specified
Type Not specified Not specified Not specified Not specified
Compression ratio Not specified Not specified Not specified Not specified
SOFTWARE Not specified Not specified Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) Ni-MH (not specified) Ni-MH (not specified) Alkaline or Ni-MH (not Alkaline or Ni-MH (not
specified) specified)
Rechargeable Yes Yes Yes (Ni-MH) Yes (Ni-MH)
Recharging time, hr 2 2 2 2
Operating time, hr 24 24 264 264
Low-battery notice Not specified Not specified Not specified Not specified
OTHER COMPATIBLE Novacor software Novacor software Novacor software Novacor software
SCANNERS
H x W x D, cm (in) 6.7 x 10.2 x 3.6 (2.6 x 4 x 6.7 x 10.2 x 3.6 (2.6 x 4 x 8.6 x 5.4 x 1.9 (3.4 x 2.1 x 8.6 x 5.4 x 1.9 (3.4 x 2.1 x
1.4) 1.4) 0.75) 0.75)
WEIGHT, g (oz) 290 (10.2) 290 (10.2) 100 (3.5) with batteries and 100 (3.5) with batteries and
CompactFlash card CompactFlash card
PURCHASE
INFORMATION
List price $4,000-7,000 $4,000-7,000 Not specified Not specified
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO 3 weeks 3 weeks 3 weeks 3 weeks
Year first sold 2003 2003 2003 2004
Number installed, Not specified NA/200 NA/280 NA/50
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Oscillometric, auscultatory Oscillometric, auscultatory 160 x 104 pixel graphical 160 x 104 pixel graphical
and gated auscultatory and gated auscultatory LCD for settings and ECG LCD for settings and ECG
ABPM; arterial compliance ABPM; arterial compliance and HR display during and HR display during
and patient activity recording. hookup and monitoring. hookup and monitoring;
recording. vocal patient diary.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED May 2006 May 2006 May 2006 May 2006
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 41


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL PHILIPS HEALTHCARE PHILIPS HEALTHCARE PROGETTI SCHILLER


DigiTrak Plus (24 hr : 48 hr) DigiTrak XT (24 hr : 48 hr : DL 800 FD-12
96 hr : 7 days)
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Adult
TYPE Retrospective, 24 hr : 48 hr Retrospective, 24, 48, 96, or Real-time Retrospective
continuous recording 7 days
RECORDER
ANNOTATION
Entry of patient ID, Not specified PID can be downloaded Keyboard PC
method from Holter app
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes Yes Yes Yes
Pacemaker detection Yes Yes Yes Yes
RECORDER
Type Direct Direct Direct, digital Digital
No. of patient lead wires 5 5-lead EASI 7 10
Modes (can record 3 or 3 3 3 Yes
12 leads with same
recorder)
Medium CompactFlash MMC SD memory card CompactFlash
Capacity, hr 24 : 48 24, 48, 96, or 7 days 24-72 24
Memory size, MB 64 : 128 24, 48, 96 hr, or 7 days 512 Not specified
Frequency resp, Hz 0.05-60 0.05-60 0.05-150 (-3 dB) 0.05-100
Sampling rate, 175 175 1,000 1,024
samples/sec
Resolution, bits 10 10 10 10
Gain/sensitivity, mm/mV Not specified Not specified 2X 2X
Calibration signal Yes Yes Yes Not specified
Signal output jack Yes Yes Yes, USB or memory card USB
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels 3
ECG 3 plus pacemaker, 12-lead 3 plus pacemaker, 12-lead 2 or 3, differential 12
derived derived
Others Pacer display, digital timing Pacer display, digital timing Not specified None
track track
Every beat Yes Yes Yes Yes
Length of time, hr 24 : 48 24, 48, 96, or 7 days 1-72 1-24
TIME DISPLAYED Yes Yes Yes Yes
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr 24 : 48 24, 48, 96, or 7 days 1-72 1-24

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

42 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL PHILIPS HEALTHCARE PHILIPS HEALTHCARE PROGETTI SCHILLER


DigiTrak Plus (24 hr : 48 hr) DigiTrak XT (24 hr : 48 hr : DL 800 FD-12
96 hr : 7 days)
DATA COMPRESSION None No Yes No
Type NA NA Not specified NA
Compression ratio NA NA Not specified NA
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) AA alkaline (not specified) AAA lithium (1) AA 1.5 (1) AA alkaline (not specified)
Rechargeable Available No Optional Yes
Recharging time, hr Not specified Not specified Depends on charger Not specified
purchased
Operating time, hr 24 : 48 24, 48, 96, or 7 days 72 24
Low-battery notice Not specified Yes, before recording is Yes Yes
started
OTHER COMPATIBLE None None None None
SCANNERS
H x W x D, cm (in) 8.6 x 6.4 x 2 (3.4 x 2.5 x 5.6 x 9.1 x 1.9 (2.2 x 3.6 x Not specified 7 x 11 x 2 (2.8 x 4.3 x 0.8)
0.8) 0.8)
WEIGHT, g (oz) 90 (3.2) 62 (2.2) Not specified 141 (5)
PURCHASE
INFORMATION
List price Not specified Not specified $2,000 Not specified
Warranty 2 years 2 years 1 year 2 years
Delivery time, ARO 30 days 30 days 30 days Not specified
Year first sold 1999 2008 2003 Not specified
Number installed, Not specified Not specified 2,000 total Not specified
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Water resistant; LCD; 5 lead Water resistant; LCD; 5 lead None specified. None specified.
wires achieve 3 wires achieve 3
conventional leads; EASI- conventional leads; EASI-
derived 12-lead ECG; derived 12-lead ECG;
nonremovable memory for nonremovable memory for
patient security; USB patient security; USB
interface; Microsoft interface; Microsoft
Signature for Windows XP. Signature for Windows XP.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED June 2010 June 2010 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 43


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SCHILLER SCHILLER SCHILLER SCHILLER


Medilog AR12 Medilog AR4 Medilog FD5 MT-101
WHERE MARKETED Worldwide, Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Adult, pediatric Adult, pediatric Adult Adult, pediatric
TYPE Real-time, retrospective Real-time, retrospective Retrospective Digital
RECORDER
ANNOTATION
Entry of patient ID, PC PC PC Menu buttons
method
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection Yes Yes Yes Yes
Pacemaker detection Yes Yes Yes Yes
RECORDER
Type Digital Digital Digital widescreen Digital
No. of patient lead wires 3, 5, 7 3, 5, 7 5, 7 7
Modes (can record 3 or No No No Yes
12 leads with same
recorder)
Medium CompactFlash CompactFlash CompactFlash SD memory card
Capacity, hr Programmable Programmable, 5 days 24, 48 24-72
Memory size, MB Not specified Not specified Not specified 512
Frequency resp, Hz 0.05-100 (1,800 0.05-100 (1,800 0.05-100 0.05-150 (-3 dB)
programmable) programmable)
Sampling rate, 4,096 4,096 1,024 1,000
samples/sec
Resolution, bits 16 16 10 10
Gain/sensitivity, mm/mV Auto Auto 2X 2X
Calibration signal Auto-calibration Auto-calibration No Yes
Signal output jack Infrared, memory card Infrared, memory card USB Yes, USB or memory card
Real-time clock (for Yes Yes Yes Yes
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 3 3 2 or 3, differential
Others Pacemaker, EDR, RR, PR, Pacemaker, RR, PR, QT None Not specified
QT
Every beat Yes Yes Yes Yes
Length of time, hr 1-72 1-72 1-48 1-72
TIME DISPLAYED With Palm handheld PDA With Palm handheld PDA Yes Yes
FULL DISCLOSURE Yes Yes Yes Yes
Length of time, hr 1-72 1-120 1-48 1-72

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

44 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SCHILLER SCHILLER SCHILLER SCHILLER


Medilog AR12 Medilog AR4 Medilog FD5 MT-101
DATA COMPRESSION Yes Not specified No Yes
Type Lossless Huffman Lossless Huffman NA SCHILLER
Compression ratio Not specified Not specified NA Not specified
SOFTWARE Yes Yes Yes Yes
UPGRADEABLE
BATTERY
Type (number) AA alkaline (not specified) AA alkaline (not specified) AA alkaline (not specified) AA 1.5 (1)
Rechargeable Yes Yes Yes Optional
Recharging time, hr 2 2 Not specified Depends on charger
purchased
Operating time, hr Programmable Programmable 24, 48 24, can charge during
recording
Low-battery notice Yes Yes Yes Yes
OTHER COMPATIBLE None None None None
SCANNERS
H x W x D, cm (in) 7 x 9 x 2 (2.8 x 3.5 x 0.8) 7 x 9 x 2 (2.8 x 3.5 x 0.8) 7 x 11 x 2 (2.8 x 4.3 x 0.8) 9.4 x 6.1 x 2 (3.7 x 2.4 x
0.8)
WEIGHT, g (oz) 75 (2.6) 75 (2.6) 141 (5) 110 (3.8) including battery
PURCHASE
INFORMATION
List price Not specified Not specified Not specified Not specified
Warranty 2 years 2 years 2 years 1 year
Delivery time, ARO 20 days 20 days 20 days 30 days
Year first sold 2001 2002 2001 2003
Number installed, Not specified Not specified Not specified Not specified/6,500
USA/worldwide
Fiscal year January to December January to December January to December January to December
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Hookup signal display on Hookup signal display on Widescreen display; Real-time ECG display.
Palm handheld; real-time P- Palm handheld; 4,096 Hz automatic QA checks.
and T-wave detection; high- signaling rate; 3-, 5-, or 7- Meets requirements of ISO
resolution HRV analysis; lead configuration. 9000.
derived 12-lead ECG;
integrated respiratory
monitoring; high-resolution
pacemaker detection.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 45


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SCOTTCARE1 SCOTTCARE1 SCOTTCARE1 SHL TELEMEDICINE


RZ153+ (Cardio ID+)2 RZ153+12 (Cardio ID+)2 RZ153+7D (Cardio ID+)2 CardioBeeper CB-12/121
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Cable Cable Cable Real-time
RECORDER
ANNOTATION
Entry of patient ID, Keypad Keypad No Not specified
method
Patient (event marker) Yes Yes Yes NA
Time Yes Yes Yes NA
Arrhythmia detection No (performed by analysis No (performed by analysis No (performed by analysis NA
system, not in the recorder) system, not in the recorder) system, not in the recorder)
Pacemaker detection Yes, selectable Yes, selectable Yes, selectable Not specified
RECORDER
Type Digital Digital Digital NA
No. of patient lead wires 5 or 7 5, 7, or 10 5 or 7 Not specified
Modes (can record 3 or 3 channel 3 or 12 channel 3 channel Not specified
12 leads with same
recorder)
Medium Removable CompactFlash Removable CompactFlash Embedded flash memory NA
Capacity, hr 24, 48, 72 24-48 24, 48, 72, 120, 168 NA
Memory size, MB Depends on CompactFlash Depends on CompactFlash 512 Not specified
card size card size
Frequency resp, Hz 0.05-60 0.05-190 for 3- and 12-lead 0.05-60 0.05-150
modes
Sampling rate, 180 Selectable, up to 1,024 180 Not specified
samples/sec
Resolution, bits 8, 10, 12; 4X oversampling 8, 10, 12; 4X oversampling 10 Not specified
Gain/sensitivity, mm/mV 5, 10, 20 5, 10, 20 10 Not specified
Calibration signal Automatic Automatic Automatic NA
Signal output jack No, RZ153+ digital No, RZ153+ digital No, RZ153+ digital NA
recorders display actual recorders display the actual recorders display the actual
ECG signal for all leads to ECG signal for all leads to ECG signal for all leads to
visualize signal quality; visualize signal quality; visualize signal quality;
provides a built-in provides a built-in provides a built-in
impedance check with lead impedance check with lead impedance check with lead
quality indicator quality indicator quality indicator
Real-time clock (for Yes Yes Yes Not specified
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 3 or 12 3 NA
Others Pacer (all models)/time Pacer (all models)/time Pacer (all models)/time Not specified
Every beat Yes Yes Yes Not specified
Length of time, hr 24, 48, 72 24-48 24, 48, 72, 120, 168 Not specified
TIME DISPLAYED Yes Yes Yes NA
FULL DISCLOSURE Yes Yes Yes Not specified
Length of time, hr Equal to recording length Equal to recording length Equal to recording length Not specified

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

46 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SCOTTCARE1 SCOTTCARE1 SCOTTCARE1 SHL TELEMEDICINE


RZ153+ (Cardio ID+)2 RZ153+12 (Cardio ID+)2 RZ153+7D (Cardio ID+)2 CardioBeeper CB-12/121
DATA COMPRESSION None None None Not specified
Type NA NA NA Not specified
Compression ratio NA NA NA Not specified
SOFTWARE Yes Yes Yes Not specified
UPGRADEABLE
BATTERY
Type (number) AA alkaline or lithium (1) AA alkaline or lithium (1) AA alkaline or lithium (2) 9 V alkaline (not specified)
Rechargeable Yes Yes Yes No
Recharging time, hr 12 12 12 NA
Operating time, hr Up to 72 Up to 48 Up to 168 30
Low-battery notice Yes, visual Yes, visual No Not specified
OTHER COMPATIBLE Rozinn Holter for Windows+ Rozinn Holter for Windows+ Rozinn Holter for Windows+ None
SCANNERS
H x W x D, cm (in) 7.1 x 9.5 x 2 (2.8 x 3.8 x 7.1 x 9.5 x 2 (2.8 x 3.8 x 6.9 x 11.1 x 2 (2.75 x 4.37 x 9.5 x 14.9 x 3.2 (3.7 x 5.9 x
0.8) 0.8) 0.8) 1.3)
WEIGHT, g (oz) 113 (4) 113 (4) 170 (6) 310 (10.9)
PURCHASE
INFORMATION
List price Varies with options, Not specified (varies with Not specified (varies with Not specified
configuration, and quantity options, configuration, and options, configuration, and
quantity) quantity)
Warranty 1 year 1 year 1 year Not specified
Delivery time, ARO 24 hr 24 hr 24 hr Not specified
Year first sold 2003 2003 2005 Not specified
Number installed, ~45,000 total for all models ~45,000 total for all models ~45,000 total for all models Not specified
USA/worldwide
Fiscal year October to September October to September October to September Not specified
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Patient first name, last Patient first name, last Check hookup on screen; all Personal 12-lead
name, DOB, in addition to name, DOB, in addition to Rozinn software products transtelephonic ECG
ID encoded on ID encoded on including Holter analysis, transmitter; continuous
CompactFlash card; all CompactFlash card; all transtelephonic monitoring, rhythm strip (lead II) and
Rozinn software products Rozinn software products and ABP monitoring may be sections of leads: I, III, V1,
including Holter analysis, including Holter analysis, installed on the same V2, V3, V4, V5, and V6
transtelephonic monitoring, transtelephonic monitoring, platform and even on the (Avr, Avl, Avf) are
and ABP monitoring may be and ABP monitoring may be same computer, if desired. reconstituted at receiver; 17
installed on the same installed on the same sec total transmission time;
platform and even on the platform and even on the 80 dB min CMRR; 0.05-150
same computer, if desired. same computer, if desired. Hz min frequency response;
<40 mV system noise.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes 1Formerly Rozinn 1Formerly Rozinn 1Formerly Rozinn

Electronics, Inc, acquired by Electronics, Inc, acquired by Electronics, Inc, acquired by


ScottCare Corp; ScottCare ScottCare Corp; ScottCare ScottCare Corp; ScottCare
is a division of Scott is a division of Scott is a division of Scott
Fetzer/Berkshire Hathaway, Fetzer/Berkshire Hathaway, Fetzer/Berkshire Hathaway,
Inc. Inc. Inc.
Model Footnotes 2Advanced, 3rd-generation 2Advanced, 3rd-generation 2Up to 7-day recording. 1Transtelephonic ECG
digital Holter recorder. digital Holter recorder. transmitter.
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 47


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SHL TELEMEDICINE SHL TELEMEDICINE SHL TELEMEDICINE SPACELABS


HEALTHCARE1
CardioPocket CB-2501 CardioSen'C River 1 Aria
WHERE MARKETED Worldwide Not specified USA Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Not specified Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Real-time Real-time Not specified Digital zero compression
RECORDER
ANNOTATION
Entry of patient ID, Not specified Yes Yes USB interface to PC or
method Preview Palm device
Patient (event marker) NA NA Yes Yes
Time NA NA Yes Yes
Arrhythmia detection NA NA Not specified No
Pacemaker detection Not specified Yes Not specified Optional
RECORDER
Type NA NA Looping Digital
No. of patient lead wires Not specified 1 belt and 2 lead wires 3 4
Modes (can record 3 or Not specified 12 leads 1 or 3 leads No
12 leads with same
recorder)
Medium NA Acoustic or cellular Acoustic or cellular Flash RAM
Capacity, hr NA NA NA Up to 48
Memory size, MB Not specified NA NA 64
Frequency resp, Hz NA 0.05-150 0.05-40 0.05-40
Sampling rate, Not specified 500 200 128
samples/sec
Resolution, bits Not specified 12 10 Not specified
Gain/sensitivity, mm/mV Not specified Not specified Yes Not specified
Calibration signal NA Not specified Not specified Automatic
Signal output jack NA Not specified Yes 128-256 scans/sec sample
rate
Real-time clock (for Not specified NA Not specified No
event marking)
RECORDING
PARAMETERS
No. of channels
ECG NA NA 2 Optional 3 (2 ECG, 1 pacer)
Others Not specified NA Not specified None specified
Every beat Not specified NA Not specified Not specified
Length of time, hr Not specified NA Not specified Not specified
TIME DISPLAYED NA NA Not specified No
FULL DISCLOSURE Not specified NA Not specified Not specified
Length of time, hr Not specified NA Not specified Not specified

This is the first of two pages


covering the above
model(s). These
specifications continue onto
the next page.

48 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SHL TELEMEDICINE SHL TELEMEDICINE SHL TELEMEDICINE SPACELABS


HEALTHCARE1
CardioPocket CB-2501 CardioSen'C River 1 Aria
DATA COMPRESSION Not specified No Yes No (digital)
Type Not specified NA Not specified NA
Compression ratio Not specified NA Not specified NA
SOFTWARE Not specified Not specified Not specified Not specified
UPGRADEABLE
BATTERY Yes
Type (number) 3 V lithium (2) Lithium (not specified) Lithium (not specified) AA alkaline or AA Ni-MH (1)
Rechargeable No No Yes Varies by external charger
Recharging time, hr NA NA Not specified NA
Operating time, hr 3 years Not specified Not specified 24 or 48
Low-battery notice Not specified Yes Yes Not specified
OTHER COMPATIBLE None Not specified Not specified 563, 363, CNAV+
SCANNERS Impresario, Sentinel
Impresario systems
H x W x D, cm (in) 9.5 x 13 x 2 (3.7 x 5.1 x 0.8) Not specified 9.5 x 3.5 x 7 (3.7 x 1.4 x 7.6 x 5.6 x 1.8 (3 x 2.2 x
2.8) 0.7)
WEIGHT, g (oz) 150 (5.3) Not specified Not specified 80 (2.8)
PURCHASE
INFORMATION
List price Not specified Not specified Not specified $1,750-1,975 with pacer
Warranty Not specified Not specified Not specified 1 year
Delivery time, ARO Not specified Not specified Not specified 4 weeks
Year first sold Not specified 2007 Not specified 2000
Number installed, Not specified Not specified Not specified >5,000 total
USA/worldwide
Fiscal year Not specified Not specified Not specified July to June
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Personal transtelephonic None specified. Personal activated Fully programmable, lead
ECG transmitter enclosed in electrocardiograph display and impedance
a billfold wallet; amplifier symptomatic event recorder check with handheld
includes common mode and transmitter; real-time, preview device; 8-bit (20
rejection of >80 dB; cellular-digital, graphic mV) resolution; dynamic
transmitter includes 0.05- display which shows the range of 5 mV; 4-electrode
150 Hz frequency, carrier status of the device, a and 3-channel hookups.
frequency of 1,700 Hz, symptoms table, an activity
deviation sensitivity of 127.5 list, programmable
Hz/uV, and FM modulation. parameters, and device
operational status.
UMDNS CODE(S) 18361 18361 16009 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes 1Acquired Del Mar Reynolds

Medical.
Model Footnotes 1Transtelephonic ECG
transmitter.
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 49


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SPACELABS SPACELABS SUZUKEN UBS INSTRUMENTS


HEALTHCARE1 HEALTHCARE1
evo Lifecard CF Kenz Cardy 301 Compas XM
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes No Yes
CE MARK (MDD) Yes Yes Yes Yes
PATIENT TYPE Not specified Not specified Not specified Not specified
TYPE Digital, zero compression Digital zero compression Retrospective Real-time
RECORDER
ANNOTATION
Entry of patient ID, Interface with PC via IR USB card reader interface Not specified Not specified
method docking station with analyzer
Patient (event marker) Yes Yes Yes Yes
Time Yes Yes Yes Yes
Arrhythmia detection No No Yes Yes
Pacemaker detection Yes Yes Not specified Not specified
RECORDER
Type Digital Digital Direct Digital
No. of patient lead wires 4 3, 4, 6, 7, or 10 Not specified Not specified
Modes (can record 3 or No Yes Not specified Not specified
12 leads with same
recorder)
Medium Internal rechargeable cell CompactFlash card Flash memory Solid-state memory
Capacity, hr Up to 48 24, 48, or 168 (7 days 24 24
continuous use)
Memory size, MB 128 90-256 Not specified Not specified
Frequency resp, Hz 0.05-40 0.05-40 0.05-40 0.05-60
Sampling rate, 2,048 1,024 Not specified Not specified
samples/sec
Resolution, bits Not specified Not specified Not specified Not specified
Gain/sensitivity, mm/mV Not specified Not specified Not specified Not specified
Calibration signal Automatic Automatic Yes No
Signal output jack 128 scans/sec sample rate 128-1,000 scans/sec Yes No
sample rate
Real-time clock (for Yes Yes Not specified Not specified
event marking)
RECORDING
PARAMETERS
No. of channels
ECG 3 3 3 3 simultaneous
Others Pacing Pacing Timing track, patient event Patient event
Every beat Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified
TIME DISPLAYED Yes Yes No Yes
FULL DISCLOSURE Not specified Not specified Not specified Not specified
Length of time, hr Not specified Not specified Not specified Not specified

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covering the above
model(s). These
specifications continue onto
the next page.

50 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart A: Recorders, Electrocardiography

MODEL SPACELABS SPACELABS SUZUKEN UBS INSTRUMENTS


HEALTHCARE1 HEALTHCARE1
evo Lifecard CF Kenz Cardy 301 Compas XM
DATA COMPRESSION No (digital) No (digital) Not specified Not specified
Type NA NA Not specified Not specified
Compression ratio NA NA Not specified Not specified
SOFTWARE Yes Yes Not specified Not specified
UPGRADEABLE
BATTERY
Type (number) Internal rechargeable cell AAA alkaline or AAA Ni-MH AAA alkaline (2) Ni-Cd pack (not specified)
(not specified) (1)
Rechargeable Yes, via docking station Varies by external charger No Yes
Recharging time, hr 5 min for 24 hr NA NA 16
Operating time, hr 48 24-48 @ 12-bit, 168 @ 10- >24 48
bit (7 day)
Low-battery notice Yes Yes Not specified Not specified
OTHER COMPATIBLE Impresario and Sentinel Sentinel, Impresario, and None specified None required
SCANNERS Holter (Pathfinder and Pathfinder Holter systems
Impresario) systems
H x W x D, cm (in) 9.6 x 5.7 x 17.5 (3.8 x 2.2 x 9.6 x 5.6 x 1.8 (3.8 x 2.2 x 5.4 x 8.5 x 1.5 (2.1 x 3.3 x 13.3 x 8.3 x 3.9 (5.3 x 3.3 x
6.9) 0.7) 0.6) 1.5)
WEIGHT, g (oz) 55 (1.9) 130 (4.6) with battery, card, 72 (2.5) with batteries 369 (13) with battery
and patient cable
PURCHASE
INFORMATION
List price $2,075 $2,225 Not specified $3,995
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO 30 days 4 weeks 1 month Not specified
Year first sold 2007 2002 (7-day model) 2002 Not specified
Number installed, Not specified >7,000 total Not specified 5,000 total
USA/worldwide
Fiscal year July to June July to June April to March Not specified
GREEN FEATURES None specified None specified None specified None specified
OTHER SPECIFICATIONS Onboard ECG display; Onboard ECG display; None specified. FD; audible and visual
dynamic energy source; up waterproof; to IPX7; records alerts; low-battery indicator;
to 48 hours of ECG, pacing up to 7 days of continuous programmable monitoring;
on all channels standard. ECG; 12-bit (2.5 mV) narrative summary; 84 full-
resolution; dynamic range of size ECG strips; ST protocol
10 mV; 3-electrode and 3- and analysis in 3 channels;
channel hookups; >5 HRV time domain analysis.
megaohms input
impedance; CMRR >60 at
10 Hz. Complies with EC38
AAMI standard.
UMDNS CODE(S) 18361 18361 18361 18361
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes 1Acquired Del Mar Reynolds 1Acquired Del Mar Reynolds

Medical. Medical.
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 51


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL ECRI INSTITUTE'S ADVANCED BIOSENSOR APPLIED CARDIAC APPLIED CARDIAC


RECOMMENDED
SPECIFICATIONS1
Basic Holter Scanners NH300 Holter Reporter MASTER Holter Reporter MASTER
Digital Digital/Tape
WHERE MARKETED Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes
CE MARK (MDD) Yes Yes Yes
HARDWARE/SOFTWARE Both Not specified Not specified
OR SOFTWARE ONLY
SYSTEM TYPE Prospective and/or Prospective, retrospective Prospective, retrospective Prospective, retrospective
retrospective
CHANNELS ANALYZED 2 3, simultaneous or individual 2 or 3 2 or 3
MAXIMUM NO. OF Unlimited Not specified Not specified
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Any Automatic or manual FD, superimposition (3-D), FD, superimposition (3-D),
page, individual or page, individual or
combination mode combination mode
Time Yes Yes Yes Yes
Heart rate Low, mean, high Yes Yes Yes
Type and size 1024 x 760 Not specified Not specified
FULL DISCLOSURE Yes Yes Annotated/tabulated Annotated/tabulated
PACEMAKER ANALYSIS Yes Yes Yes Yes
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Yes
ST-segment analysis Yes Yes Yes Yes
No. of classifications No specific number required 28 Multiple Multiple
PATIENT EVENT STOP Not required Yes Yes Yes
TAPE PLAYBACK TYPE Any NA Digital Digital/cassette
PLAYBACK TYPE
Cassette Acceptable No No Yes
Reel-to-reel Acceptable No No No
Digital Acceptable Yes Yes Yes
PRINTER Any Any PCL5 or PCL6 Windows compatible Windows compatible
compatible
REMOTE TRANSMISSION Not required Yes Remote download, remote Remote download, remote
edit, fax, e-mail edit, fax, e-mail
PC COMPATIBLE Preferred Yes Yes Yes
UPGRADEABLE Preferred Yes Not specified Not specified
NETWORKABLE Preferred Yes Yes Not specified

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

52 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL ECRI INSTITUTE'S ADVANCED BIOSENSOR APPLIED CARDIAC APPLIED CARDIAC


RECOMMENDED
SPECIFICATIONS1
Basic Holter Scanners NH300 Holter Reporter MASTER Holter Reporter MASTER
Digital Digital/Tape
STORAGE CAPABILITIES
Hard disk Any Yes ≥120 GB ≥120 GB
Long-term medium Any CD-R or any storage media DVD-RW DVD-RW
Heart rate Optional Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format Customizable User-defined User-defined
Event marker summary Not required Yes Yes, in context Yes, in context
Strip annotation Time, patient ID, HR, strip Time, patient name/ID, Time, patient name/ID, strip Time, patient name/ID, strip
annotation (e.g., arrhythmia arrhythmia annotate, HR, speed, arrhythmia annotate, speed, arrhythmia annotate,
annotate) narrative HR, narrative, msec interval HR, narrative, msec interval
calipers calipers
STRIP EXPANSION ON FD Yes Yes Annotated Annotated
REPORT
DATA MANAGEMENT Preferred Yes Yes Yes
Export method .ini Various Various
Export data format .ini Various Various
HL7 interfaces .ini Yes Yes
PREFERRED RECORDER AB-180R Applied Cardiac Systems Applied Cardiac Systems
high-resolution digital high-resolution cassette or
digital
Accepts others Yes No Yes
WEB-BASED No Yes, IMS is .NET enabled Yes, IMS is .NET enabled
RESOURCES
Operating system and NA Not specified Not specified
application
vulnerabilities
Software patches NA Not specified Not specified
PURCHASE
INFORMATION
List price, std $3,995 Not specified Not specified
configuration
Warranty Life of product 1 year 1 year
Delivery time, ARO Next day upon request 7 days (guaranteed) 7 days (guaranteed)
Year first sold 2000 Not specified Not specified
Number installed
USA/worldwide 400/100 Not specified Not specified
Fiscal year July to June Not specified Not specified

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model(s). These
specifications continue onto
the next page.

©2010 ECRI Institute. All Rights Reserved. 53


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL ECRI INSTITUTE'S ADVANCED BIOSENSOR APPLIED CARDIAC APPLIED CARDIAC


RECOMMENDED
SPECIFICATIONS1
Basic Holter Scanners NH300 Holter Reporter MASTER Holter Reporter MASTER
Digital Digital/Tape
OTHER SPECIFICATIONS Windows Windows XP certified; Windows XP certified;
98/NT/2000/XP/Vista. ODBC SQL database; ODBC SQL database;
network and Internet ready; network and Internet ready;
PDF generator; flash or PDF generator; flash or
USB download capabilities; USB download capabilities;
simultaneous audible patient diary
superimposition, onscreen playback; simultaneous
ECG paging or scrolling, superimposition, onscreen
and FD printing; batch ECG paging or scrolling,
processing of up to 1,000 and FD printing; batch
patients; accurate pacer and processing of up to 1,000
pediatric waveform patients; accurate pacer and
reproduction; compatible pediatric waveform
with ACS Instrument reproduction; compatible
Management System "IMS" with ACS Instrument
for low-cost EMR interface Management System "IMS"
and worldwide data access. for low-cost EMR interface
and worldwide data access.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2007 May 2006 May 2006
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

54 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS CARDIAC SCIENCE


Century 1000 Century 2000 Century 3000 Burdick VISION
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Not specified Not specified Not specified Software only or with
OR SOFTWARE ONLY optional computer hardware
SYSTEM TYPE Retrospective Prospective, retrospective Prospective, retrospective Retrospective
CHANNELS ANALYZED 2, 3, or 12 2, 3, or 12 2, 3, or 12 3
MAXIMUM NO. OF Not specified Not specified Not specified Unlimited
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Progress bar, retrospective FD, superimposition, FD, superimposition, FD, page, template,
template editing template editing histogram, arrhythmiagraph
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size Not specified Not specified Not specified 48.3 cm (19") LCD or user-
supplied
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Yes Yes Yes Optional
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Yes
ST-segment analysis Yes Yes Yes Yes
No. of classifications 200 200 200 5
PATIENT EVENT STOP Yes Yes Yes Yes
TAPE PLAYBACK TYPE Cassette and flash card Cassette and flash card Cassette and flash card Digital
PLAYBACK TYPE
Cassette Yes Yes Yes No
Reel-to-reel No No No No
Digital Yes Yes Yes Yes
PRINTER Windows printers Windows printers Windows printers Ink-jet or laser
REMOTE TRANSMISSION Internet, direct connection Internet, direct connection Internet, direct connection Yes
PC COMPATIBLE Yes Yes Yes Yes
UPGRADEABLE Not specified Not specified Not specified Yes
NETWORKABLE Not specified Not specified Not specified Yes

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

©2010 ECRI Institute. All Rights Reserved. 55


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS CARDIAC SCIENCE


Century 1000 Century 2000 Century 3000 Burdick VISION
STORAGE CAPABILITIES
Hard disk Yes Yes Yes Yes
Long-term medium Floppy and optical disks, Floppy and optical disks, Floppy and optical disks, CD-RW or network drive
tape Zip drive, network drive tape Zip drive, network drive tape Zip drive, network drive
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format Flexible or customized Flexible or customized Flexible or customized Flexible
Event marker summary Yes Yes Yes Yes
Strip annotation Time, patient name/ID, strip Time, patient name/ID, strip Time, patient name/ID, strip Patient name/ID, HR, time,
speed, R-R gain, HR, speed, R-R gain, HR, speed, R-R gain, HR, arrhythmia annotation,
narrative, arrhythmia, and narrative, arrhythmia, and narrative, arrhythmia, and rhythm strip, ST, miniature 7
user user user sec rhythm strip; all are
automatic
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT ISA/PCI ISA/PCI ISA/PCI Yes
Export method Not specified Not specified Not specified Varies
Export data format Not specified Not specified Not specified Alphanumeric text, report
image
HL7 interfaces Not specified Not specified Not specified Yes
PREFERRED RECORDER BMS cassette and Flash BMS cassette and Flash BMS cassette and Flash Vision 5L or Vision 5LR
card recorder card recorder card recorder (research)
Accepts others Yes Yes Yes Yes
WEB-BASED Not specified Not specified Not specified Yes
RESOURCES
Operating system and Not specified Not specified Not specified Windows XP Pro or Vista
application Home Premium
vulnerabilities
Software patches Not specified Not specified Not specified User installable as available
PURCHASE
INFORMATION
List price, std Not specified Not specified Not specified $7,065, includes software
configuration and 1 recorder
Warranty 2 years 2 years 2 years 1 year
Delivery time, ARO 3 weeks 3 weeks 3 weeks 2-3 weeks
Year first sold 2002 1995 1995 Not specified
Number installed
USA/worldwide Not specified Not specified Not specified Not specified
Fiscal year January to December January to December January to December January to December

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model(s). These
specifications continue onto
the next page.

56 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS BIOMEDICAL SYSTEMS CARDIAC SCIENCE


Century 1000 Century 2000 Century 3000 Burdick VISION
OTHER SPECIFICATIONS Custom scan profiles; Custom scan profiles; Batch processing; full Software-guided hookup
Windows based; Windows Windows based; Windows remote satellite module with wizard; guided review of
98/2000/XP compatible; 24 98/2000/XP compatible; 24 report data transmission; configurable final report;
hr modem or Internet hr modem or Internet network compatible; 24 hr built-in fax/modem and CD-
support; Internet software support; Internet software modem or Internet support; RW; network compatibility;
access; compatible with access; compatible with template matching; QT and satellite operation;
other Windows applications; other Windows applications; HRV analysis; enhanced ST nonproprietary data
pacemaker analysis; spike pacemaker analysis; spike analysis; ASCII roles export. exchange formats;
P-wave detection. CE P-wave detection. Meets instructional AVIs; hookup
certified. requirements of GLEM. CE verification display; strip
certified. annotation includes clinical
limits legend;
arrhythmiagraph; optional
HRV (both time and
frequency domain) with
optional pacemaker
software.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 57


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL CARDIAC SCIENCE ELA/SORIN GROUP ET MEDICAL DEVICES GALIX


Burdick VISION PREMIER SyneScope CARDIOLINE WinTer1
CUBEHOLTER
WHERE MARKETED Worldwide Asia, Australia, Europe, Worldwide Worldwide
Japan, North America
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Submitted
HARDWARE/SOFTWARE Software only or with Both Both Software, hardlock, and
OR SOFTWARE ONLY optional computer hardware memory card reader
SYSTEM TYPE Retrospective Retrospective Retrospective Retrospective
CHANNELS ANALYZED 3 2-12 3 and 12 3
MAXIMUM NO. OF Unlimited Depends on HD size, Unlimited Unlimited
RECORDERS FOR unlimited if stored on
ANALYSIS AND CD/DVD
STORAGE
SCAN DISPLAY
Scanning modes Superimposition, FD, page, Superimposition, page, line FD, superimposition, page, FD, page scroll, event,
template, histogram, template, custom trends, backup module,
arrhythmiagraph templates, morphologies,
print preview
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size 48.3 cm (19") LCD or user- Selectable Not specified PC monitor
supplied
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Optional Yes Yes Yes, for both atrial and
ventricular pacemakers
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Trends over 24 hr Yes Yes
ST-segment analysis Yes Trends over 24 hr Yes Yes
No. of classifications 14 16 24 26
PATIENT EVENT STOP Yes Yes Yes Yes
TAPE PLAYBACK TYPE Digital Cassette, flash memory USB or flash card reader Memory card reader
card
PLAYBACK TYPE
Cassette No Yes No No (discontinued)
Reel-to-reel No No Not specified No (discontinued)
Digital Yes Flash card Via USB port or flash card Yes
reader
PRINTER Ink-jet or laser HP laser compatible Laser PostScript All Windows compatible
REMOTE TRANSMISSION Yes Network, e-mail, Web-mail Yes Internet, WAN, LAN
PC COMPATIBLE Yes Yes Yes Yes
UPGRADEABLE Yes Yes Yes Yes
NETWORKABLE Yes Yes Yes Yes

This is the first of three


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

58 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL CARDIAC SCIENCE ELA/SORIN GROUP ET MEDICAL DEVICES GALIX


Burdick VISION PREMIER SyneScope CARDIOLINE WinTer1
CUBEHOLTER
STORAGE CAPABILITIES
Hard disk Yes Hardware-dependent Yes Yes
Long-term medium CD-RW or network drive CD, DVD, optical, network Hard, floppy disk, CD-R, Hard, optical disk
DVD
Heart rate Yes Yes (text report) Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes, also supraventricular
and QT
REPORT OPTIONS
Format Flexible Flexible Flexible or customized Customized
Event marker summary Yes Yes Yes Yes
Strip annotation Patient name/ID, HR, time, Yes Time, patient name/ID, strip Time, patient name/ID, strip
arrhythmia annotation, speed, HR, arrhythmia speed, HR, arrhythmia
rhythm strip, ST, miniature 7 annotate, comments annotate, narrative, interval
sec rhythm strip plus
custom annotations; all are
automatic
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Export to ASCII Yes Yes
Export method Varies Automatic and manual Manual, automatic, e-mail Proprietary, complete
backup module
Export data format Alphanumeric text, report ISHNE, ASCII, text PDF, TXT, XML, GDT Data table
image
HL7 interfaces Yes No Optional Yes
PREFERRED RECORDER Vision 5L or Vision 5LR All ELA recorders CARDIOLINE CLICK Holter Galix GBI-3S, GBI-3S-LP,
(research) and CARDIOLINE GBI-3SM
PRIMAholter
Accepts others Yes All tape recorders Not specified Yes, under special
agreement only
WEB-BASED Yes Yes Not specified Yes
RESOURCES
Operating system and Windows XP Pro or Vista Vista and Vista SP1 OK Windows 2000/XP Not specified
application Home Premium
vulnerabilities
Software patches User installable as available No Not specified Not specified
PURCHASE
INFORMATION
List price, std $8,065, includes software Not specified $10,000 Not specified
configuration and 1 recorder
Warranty 1 year 2 years 1 year 3 years
Delivery time, ARO 2-3 weeks 4 weeks 2 weeks 3 days
Year first sold Not specified 1980 2005 1996
Number installed
USA/worldwide Not specified 200/8,000 Not specified Not specified
Fiscal year January to December Not specified January to December March to February

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

©2010 ECRI Institute. All Rights Reserved. 59


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL CARDIAC SCIENCE ELA/SORIN GROUP ET MEDICAL DEVICES GALIX


Burdick VISION PREMIER SyneScope CARDIOLINE WinTer1
CUBEHOLTER
OTHER SPECIFICATIONS Software-guided hookup HR variability module; QT Windows compatible; Windows based; template
wizard; guided review of analysis module; multiple pacemaker morphology matching; ST and QT
configurable final report; network stations; P-wave analysis; HRV analysis in analysis; onscreen report
built-in fax/modem and CD- analysis module; late- time domain; networking preview; customizable
RW; network compatibility; potential analysis module; capability; optional tools for hourly table; works with all
satellite operation; compatible with Holter QT analysis, HRV analysis Windows operating
nonproprietary data recordings up to 12 in frequency domain, and systems; high-speed
exchange formats; channels (up to 4 days); late-potential analysis; download; HRV; time and
instructional AVIs; hookup Tvar, Pwave. optional data management frequency domain; sleep
verification display; strip software with long-term apnea analysis module;
annotation includes clinical storage on CD or DVD. unlimited graphic Holter
limits legend; database and archiving;
arrhythmiagraph; optional patient diary automatically
HRV (both time and printed; real-time ECG
frequency domain) with signal from recorder
optional pacemaker monitored at PC display;
software. proprietary noise analysis;
network compatible; remote
24 hr ECG data and report
transmission over Internet,
satellite, fiberoptic, other;
integration to Galix ECG
Professional Station with
computerized stress test
and ventricular late-potential
analysis; ventricular late
potential module; time and
frequency domain HRV;
recording noise analysis;
print preview of everything
to be printed.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes 1New interactive screen
design improves
effectiveness and reliability.
Data Footnotes

60 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL GE HEALTHCARE GETEMED MEDSET MIDMARK DIAGNOSTICS


GROUP (BRENTWOOD)
MARS V7.2 Cardio Day CARDIOLIGHT PADSY IQmark Advanced Holter
JAVA application
WHERE MARKETED Worldwide Europe; USA by GE Worldwide Worldwide
Healthcare
FDA CLEARANCE Yes Yes Submitted Yes
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Both Hardware (CardioMem CM Complete system with PC or Software only
OR SOFTWARE ONLY 3000, CM 3000 SM, CM software package
3000-12, and CM 3000-12
BT) and software
(CardioDay)
SYSTEM TYPE Retrospective, prospective, Retrospective Prospective, retrospective Retrospective
paging, event scan,
superimposition scan,
waterfall review
CHANNELS ANALYZED 2, 3, or 12 2, 3, or 12 1, 2, 3 1, 2, or 3
MAXIMUM NO. OF >100 >4,000 Unlimited, depends on Unlimited
RECORDERS FOR capacity of hard disk/server
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Retrospective, prospective, FD, superimposition, event, Strips, templates, Preview, templates, sample
paging, event scan, page, strips, templates, superimposition, events strips, FD, page scan
superimposition scan, QuickScan
waterfall review
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size 50.8 cm (20"), 1024 x 768, Yes 38.1 cm (15") 1024 x 768 recommended,
high resolution any Windows-supported
display
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Yes Yes Yes Optional
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Color code/annotate
ST-segment analysis Yes Yes Yes Yes
No. of classifications 15 Typical 30; 1,000 maximum 26 (plus 12 pacemaker 13
classes)
PATIENT EVENT STOP Yes Yes Yes NA
TAPE PLAYBACK TYPE PCMCIA, CompactFlash Digital, 1-2 mm cassettes Digital None
cards, direct USB connect
to all-digital recorder
PLAYBACK TYPE
Cassette No Yes No No
Reel-to-reel No No No No
Digital Yes Yes Yes PCMCIA or CompactFlash
card reader
PRINTER Network laser All Windows All available printers running Windows-supported printers
on OS
REMOTE TRANSMISSION Yes Yes Yes Network or e-mail
PC COMPATIBLE Yes Yes Yes Windows-based PC
UPGRADEABLE Yes Yes Yes Yes
NETWORKABLE Yes Yes Yes Yes

These specifications
continue onto the next two
pages.

©2010 ECRI Institute. All Rights Reserved. 61


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL GE HEALTHCARE GETEMED MEDSET MIDMARK DIAGNOSTICS


GROUP (BRENTWOOD)
MARS V7.2 Cardio Day CARDIOLIGHT PADSY IQmark Advanced Holter
JAVA application
STORAGE CAPABILITIES
Hard disk Yes Yes Yes Yes
Long-term medium MUSE CV, CD-R, DVD-R, Hard disk, optical disk, tape, All available media Any backup system
network drives CD-R, DVD-R
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format Flexible, customized Hardcopy, PDF, TIFF, XML Flexible or customized User-selectable
Event marker summary Yes Yes Yes Yes
Strip annotation Time, patient name, HR, Time, patient name/ID, strip Time, patient name/ID, strip Time, patient name/ID, beat
beat label, R-R interval, speed, arrhythmia, HR, speed, arrhythmia annotate, annotation, intervals, HR,
symptom or activity, rhythm beat-to-beat, comments HR, narrative custom label, arrhythmia
abnormality, atrial classification
fibrillation, atrial flutter
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT MUSE CVIS, CD-R, HD, Yes Yes Yes
DVD, EMR export
Export method Raw, MIT formats, research Flexible Yes Archive
formats, PDF
Export data format Raw, MIT formats, research Flexible Medset format *.car, PDF
formats, PDF
HL7 interfaces Via MUSE Yes GDT/HL7 interface software No
PREFERRED RECORDER SEER MC2, SEER Light, CardioMem CM 3000(-12) CARDIOLIGHT IQmark Digital Holter
SEER Light Extend, 8500 or getemed R151A TELESMART, SMART, RecorderCF
analog tape FMC-A, FCO, Braemar
Accepts others Yes Yes Yes No
WEB-BASED Yes Yes Yes, for scanning evaluation No
RESOURCES center
Operating system and Windows Windows 2000/XP/Vista Windows XP Service Pack 2 NA
application or higher, Windows Vista,
vulnerabilities Mac OS 10.4 or 10.5
Software patches Yes Provided as necessary 2-3 updates yearly NA
PURCHASE
INFORMATION
List price, std Not specified $10,000, basic software and €3,900 (US$5,251) $8,454, includes 1 IQmark
configuration 1 recorder Digital Holter RecorderCF
and hookup kits
Warranty 1 year, hardware; 90 days, 2 years 1 year 1 year
software
Delivery time, ARO 30-45 days 2 weeks 2 weeks 24 hr
Year first sold 2001 1992 1999 Not specified
Number installed
USA/worldwide >3,000 total 500/1,500 0/1,000 Not specified
Fiscal year January to December January to December January to December January to December

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62 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL GE HEALTHCARE GETEMED MEDSET MIDMARK DIAGNOSTICS


GROUP (BRENTWOOD)
MARS V7.2 Cardio Day CARDIOLIGHT PADSY IQmark Advanced Holter
JAVA application
OTHER SPECIFICATIONS Fully scalable solution Network connection; QT, Patient Diagnostic System Includes IQmark Diagnostic
supports low-to-high volume PQ, and HRV analysis (time (PADSY) with Holter ECG Workstation for patient
enterprisewide facilities in and frequency domain), analysis software; other record management;
stand-alone or full batch print; batch applications optional; local/network reviewing and
client/server platform with processing; frequency solutions for network editing support; auto report;
up to 25 simultaneous pacemaker analysis; late systems; ECG data transfer beat editing and template
clients; 5 styles of potentials; AFib detection; via TCP/IP; 48 hr event editing; AFib, QT/QTc and
processing respiration analysis; 12- overview with ECG strips; HRV analysis; color-coded
(template/retrospective, channel measurement. caliper and editors (single arrhythmia; event strips;
paging beat, episode, area, print continuous diagnostic
prospective/superimposition, template); examples; ST strips; e-mails; saves in full
event scan, waterfall and reanalysis; HRV and or summary report format.
review); true 12-lead Holter pacemaker analysis; QT
with 12-single lead and AFib analysis; TCP/IP
measurements; ST-segment for telemedicine
elevation/depression; beat- applications.
to-beat QT; new Sudden
Cardiac Death Risk
Stratification algorithms (T-
wave alternans and heart
rate turbulence). Meets
requirements of AAMI EC-
11, ISO 9001, and UL 544.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 63


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL MIDMARK DIAGNOSTICS MIDMARK DIAGNOSTICS MORTARA INSTRUMENT NASIFF


GROUP (BRENTWOOD) GROUP (BRENTWOOD)
IQmark Advanced with IQmark EZ Holter H-Scribe Cardio-Holter
Pacemaker Analysis
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes No
HARDWARE/SOFTWARE Software only Software only Both Not specified
OR SOFTWARE ONLY
SYSTEM TYPE Retrospective Retrospective Prospective, retrospective, Prospective, retrospective
superimposition
CHANNELS ANALYZED 1, 2, or 3 1, 2, or 3 2, 3, 12 3
MAXIMUM NO. OF Unlimited Unlimited Unlimited Not specified
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Preview, templates, sample Sample strips, FD, page Page mode and FD
strips, FD, page scan scan superimposition with stop
criteria, retrospective
autoscan
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size 1024 x 768 recommended, 1024 x 768 recommended, 48.3 cm (19") LCD or 61 cm Not specified
any Windows-supported any Windows-supported (24") wide TFT-LCD
display display
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Yes No Yes Yes
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Color code/annotate Color code/annotate Yes Yes
ST-segment analysis Yes Yes Yes Yes
No. of classifications 21 11 15; 7 beat labels 10
PATIENT EVENT STOP NA NA Yes Yes
TAPE PLAYBACK TYPE None None Optional 1 mm/sec cassette Digital
tape drive
PLAYBACK TYPE
Cassette No No Yes No
Reel-to-reel No No No No
Digital PCMCIA or CompactFlash PCMCIA or CompactFlash Yes Yes
card reader card reader
PRINTER Windows-supported printers Windows-supported printers HP LaserJet or Windows Any Windows-compatible
printer printer
REMOTE TRANSMISSION Network or e-mail Network or e-mail H-Scribe network and Web Yes
transfer
PC COMPATIBLE Windows-based PC Windows-based PC Yes Yes
UPGRADEABLE Yes Yes Yes Yes
NETWORKABLE Yes Yes Yes Yes

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64 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL MIDMARK DIAGNOSTICS MIDMARK DIAGNOSTICS MORTARA INSTRUMENT NASIFF


GROUP (BRENTWOOD) GROUP (BRENTWOOD)
IQmark Advanced with IQmark EZ Holter H-Scribe Cardio-Holter
Pacemaker Analysis
STORAGE CAPABILITIES
Hard disk Yes Yes 160 GB Yes
Long-term medium Any backup system Any backup system DVD, CD or any arbitrary Any PC media
drive
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format User-selectable User-selectable User-defined Standard and customized
Event marker summary Yes Yes Yes Yes
Strip annotation Time, patient name/ID, beat Time, patient name/ID, beat Yes Yes
annotation, intervals, HR, annotation, intervals, HR,
custom label, arrhythmia custom label, arrhythmia
classification classification
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Yes Yes Yes
Export method Archive Archive User-defined Not specified
Export data format *.car, PDF *.car, PDF XML, PDF Binary, ASCII, PDF
HL7 interfaces No No Yes Custom
PREFERRED RECORDER IQmark Digital Holter IQmark Digital Holter H-12, H12+, H3+ Nasiff H1
RecorderCF RecorderCF
Accepts others No No Cassette tape (1 mm/sec) Yes
WEB-BASED No No No Yes
RESOURCES
Operating system and NA NA NA Not specified
application
vulnerabilities
Software patches NA NA NA Not specified
PURCHASE
INFORMATION
List price, std $11,069, includes 1 IQmark $6,146, includes 1 IQmark Not specified $3,195
configuration Digital Holter RecorderCF Digital Holter RecorderCF
and hookup kits and hookup kits
Warranty 1 year 1 year 1 year 2 years
Delivery time, ARO 24 hr 24 hr 30 days 1 week
Year first sold Not specified Not specified 1995 1996
Number installed
USA/worldwide Not specified Not specified Not specified Not specified
Fiscal year January to December January to December January to December January to December

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©2010 ECRI Institute. All Rights Reserved. 65


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL MIDMARK DIAGNOSTICS MIDMARK DIAGNOSTICS MORTARA INSTRUMENT NASIFF


GROUP (BRENTWOOD) GROUP (BRENTWOOD)
IQmark Advanced with IQmark EZ Holter H-Scribe Cardio-Holter
Pacemaker Analysis
OTHER SPECIFICATIONS Includes IQmark Diagnostic Includes IQmark Diagnostic Continuous 12-lead ECG Seamless integration to
Workstation for patient Workstation for patient data acquisition and 12-lead cardio database with ECG,
record management; record management; ST-segment analysis; stress, and other tests;
local/network reviewing and local/network reviewing and traditional 2- or 3-channel powerful beat editing
editing support; auto report; editing support; auto report; Holter recorder acquisition functions; beat
beat editing and template beat editing and group depending on recorder type; measurements.
editing; AFib, QT/QTc and editing; color-coded pacemaker analysis; heart
HRV analysis; color-coded arrhythmia; event strips; rate variability; automatic
arrhythmia; event strips; print continuous diagnostic arrhythmia event selection;
print continuous diagnostic strips; e-mails; saves in full onscreen report preview;
strips; e-mails; saves in full or summary report formats. Windows architecture;
or summary report formats. support for up to 48 hr of
recording; Web upload
option allows remote Holter
data transfer via
intranet/Internet.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2007
Supplier Footnotes
Model Footnotes
Data Footnotes

66 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL NORAV MEDICAL NOVACOR PHILIPS HEALTHCARE PROGETTI


NH-300 HOLTERSOFT ULTIMA 1810 : 2010 PG 8
WHERE MARKETED Worldwide Africa, Asia/Pacific, Europe, Worldwide Worldwide
Middle East
FDA CLEARANCE Yes Submitted Yes No
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Software only Not specified Software only (recorders Not specified
OR SOFTWARE ONLY sold separately)
SYSTEM TYPE Retrospective Retrospective, automatic Retrospective, prospective Retrospective, prospective
CHANNELS ANALYZED 3, simultaneous or individual 1, 2, or 3 3 3
MAXIMUM NO. OF Unlimited Not specified Not specified Not specified
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Automatic or manual Trends, histograms, strips, Philips QuickScan, paging, FD, superimposition,
FD, events, templates superimposition, compressed
retrospective
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size Depends on PC monitor Not specified Not specified Not specified
used
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Yes Yes Yes Yes
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Yes
ST-segment analysis Yes Yes Yes Yes
No. of classifications 18 22 User-defined Multiple
PATIENT EVENT STOP Yes Yes Yes Yes
TAPE PLAYBACK TYPE NA PCMCIA or CompactFlash USB Digital flash card
cards
PLAYBACK TYPE
Cassette No No No No
Reel-to-reel No No No No
Digital Yes Yes Yes Yes
PRINTER Any PCL5 or PCL6 Most Widely compatible Laser
compatible
REMOTE TRANSMISSION Yes Yes Optional Internet
PC COMPATIBLE Yes Yes Yes Yes
UPGRADEABLE Yes Not specified Yes Not specified
NETWORKABLE Yes Not specified Yes Not specified

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©2010 ECRI Institute. All Rights Reserved. 67


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL NORAV MEDICAL NOVACOR PHILIPS HEALTHCARE PROGETTI


NH-300 HOLTERSOFT ULTIMA 1810 : 2010 PG 8
STORAGE CAPABILITIES
Hard disk Yes Yes Yes Yes
Long-term medium DVD-R, CD-R, or any Hard disk, tape, optical, Zip, Hard, floppy disk; 3rd-party Floppy, HD, CD, DVD
storage media CD-R options internal/external Zip,
Jaz, CD-R, and DVD-R
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format Customizable User-customized Customizable Flexible and customized
Event marker summary Yes No Not specified Yes
Strip annotation Time, patient name/ID, Time, patient name/ID, strip Time, patient name/ID, HR, Time, patient name/ID, strip
arrhythmia annotate, HR, speed, arrhythmia annotate, arrhythmia annotate, gain speed, arrhythmia annotate,
medication, narrative HR, narrative HR, narrative
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Yes Yes Yes
Export method User-specified Not specified Not specified Not specified
Export data format PDF, GDT Not specified PDF Not specified
HL7 interfaces Yes Not specified Yes Not specified
PREFERRED RECORDER DL-900 Novacor VISTA, VISTA Philips DigiTrak XT Any digital
ACCESS, VISTA PLUS
Accepts others DL-800, DL-800HR, Novacor UNOLTER, DigiTrak Plus and XT only No
DXP1000 DUOLTER, TRIOLTER, or
QUATTROLTER
WEB-BASED Yes Not specified Not specified Not specified
RESOURCES
Operating system and Yes, via distributor Not specified Holter 2.9 is only supported Not specified
application on Microsoft Vista, Windows
vulnerabilities XP Pro, Windows 2003
server
Software patches Yes, via distributor Not specified Not specified Not specified
PURCHASE
INFORMATION
List price, std Not specified $6,000 Not specified Not specified
configuration
Warranty 1 year 1 year and hotline 1 year Not specified
Delivery time, ARO Not specified 3 weeks 30-45 days Not specified
Year first sold 2001 2002 2008 Not specified
Number installed
USA/worldwide Not specified NA/480 >2,000 total Not specified
Fiscal year January to December January to December January to December Not specified

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68 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL NORAV MEDICAL NOVACOR PHILIPS HEALTHCARE PROGETTI


NH-300 HOLTERSOFT ULTIMA 1810 : 2010 PG 8
OTHER SPECIFICATIONS Includes SAECG, QT, LQT, Windows-based software Configured to scan standard Windows based; exportable
and HRV analysis; free (Windows 98/ME/2000/XP); 2- or 3-channel atrial format report.
software updates for life of ABPM; QT; HRV; automatic fibrillations; IVCD/BBB;
system. AF and sleep apnea pacer; infant/pediatric sinus
modules; patient activity rhythm/easy; marked sinus
analysis; vocal patient arrhythmia; HRV, QT, and
journal replay. pacer analysis; artifact/no
ectopy; artifact/ectopy;
optional networking/remote
transmission, derived 12-
lead, and fax capabilities;
Windows XP compatible.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 May 2006 June 2010 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 69


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCHILLER SCHILLER SCHILLER SCHILLER


Medilog Excel 3 Medilog Prima-3 Kit medilogDarwin MT-200
WHERE MARKETED Worldwide, except USA Worldwide, except USA Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Not specified Not specified Software only Software only
OR SOFTWARE ONLY
SYSTEM TYPE Retrospective Retrospective Analysis software Analysis software
CHANNELS ANALYZED 2 or 3 2 or 3 1-12 3, simultaneous or individual
MAXIMUM NO. OF Not specified Not specified Unlimited Unlimited
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes FD, superimposition, FD, superimposition, Retrospective Automatic or manual
template edit, page, report template edit, page, report
review review
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size Not specified Not specified Depends on PC monitor Depends on PC monitor
used used
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Yes Yes Yes Yes
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Yes
ST-segment analysis Yes Yes Yes Yes
No. of classifications 60 60 Unlimited 20
PATIENT EVENT STOP Yes Yes Yes Yes
TAPE PLAYBACK TYPE Digital Digital Digital NA
PLAYBACK TYPE
Cassette No No No No
Reel-to-reel No No No No
Digital Yes Yes Yes Yes
PRINTER Laser User-configured Any Any PCL5 or PCL6
compatible
REMOTE TRANSMISSION Yes Yes Yes Yes
PC COMPATIBLE Yes Yes Yes Yes
UPGRADEABLE Not specified Not specified Yes Yes
NETWORKABLE Not specified Not specified Yes Yes

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70 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCHILLER SCHILLER SCHILLER SCHILLER


Medilog Excel 3 Medilog Prima-3 Kit medilogDarwin MT-200
STORAGE CAPABILITIES
Hard disk Yes Yes Yes Yes
Long-term medium Floppy disk, CD writer, User-configured CD, DVD CD-R or any storage media
network
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes Yes
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format Fixed, flexible, or Fixed, flexible, or Customizable Customizable
customized customized
Event marker summary Yes Yes Yes Yes
Strip annotation Yes Yes Time, patient name/ID, Time, patient name/ID,
arrhythmia annotate, HR, arrhythmia annotate, HR,
medication, narrative medication, narrative
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Yes Yes Yes
Export method Not specified Not specified File, TCP/IP SCHILLER compatible
Export data format Not specified Not specified HL7, GDT, BDT SCHILLER
HL7 interfaces Not specified Not specified Yes Yes
PREFERRED RECORDER Oxford Instruments Medilog Oxford Instruments Medilog Oxford Instruments Medilog SCHILLER MT-101
FD4, FD5, AR4, or AR12 FD4, FD5, AR4, or AR12 FD4, FD5, AR4, or AR12,
SCHILLER MT-101, BR-
200+
Accepts others No No Yes No
WEB-BASED Not specified Not specified No Yes
RESOURCES
Operating system and Not specified Not specified NA Yes
application
vulnerabilities
Software patches Not specified Not specified NA Yes
PURCHASE
INFORMATION
List price, std Not specified Not specified Not specified Not specified
configuration
Warranty 1 year 1 year Not specified 1 year
Delivery time, ARO 30 days 30 days Not specified 30 days
Year first sold 1992 1992 Not specified 2003
Number installed
USA/worldwide Not specified Not specified Not specified Not specified/6,500
Fiscal year January to December January to December January to December January to December

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©2010 ECRI Institute. All Rights Reserved. 71


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCHILLER SCHILLER SCHILLER SCHILLER


Medilog Excel 3 Medilog Prima-3 Kit medilogDarwin MT-200
OTHER SPECIFICATIONS Advanced ischemia, ST, Report upload <5 sec; 40 None specified. Windows 2000/XP/Vista.
and HRV analysis; 40 full recordings online; optional
records online; batch print; ABP. Meets requirements of
fax; networking. Meets BS 5750 Part 1, EN 29001,
requirements of BS 5750 IEC 601, ISO 9001, and UK
Part 1, EN 29001, IEC 601, DOH.
ISO 9001, and UK DOH.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes
Model Footnotes
Data Footnotes

72 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCOTTCARE1 SCOTTCARE1 SCOTTCARE1 SCOTTCARE1


Holter for Windows1+ Holter for Windows2+ Holter for Windows3+ RapidScan+
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Both Both Both Both
OR SOFTWARE ONLY
SYSTEM TYPE Retrospective and Retrospective and Retrospective and Retrospective and
prospective prospective prospective prospective
CHANNELS ANALYZED Any 1, 2, 3, or 8 Any 1, 2, 3, or 8 Any 1, 2, 3, or 8 Any 1, 2, or 3
MAXIMUM NO. OF Number of recorders Number of recorders Number of recorders Number of recorders
RECORDERS FOR unlimited, number of unlimited, number of unlimited, number of unlimited, number of
ANALYSIS AND patients limited only by free patients limited only by free patients limited only by free patients limited only by free
STORAGE disk space disk space disk space disk space
SCAN DISPLAY
Scanning modes FD, superimposition, page FD, superimposition, page FD, superimposition, page FD, superimposition, page
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size Templates, measurement Templates, measurement Templates, measurement Color-coded beats and
cursors, and text; separate cursors, and text; separate cursors, and text; separate measurement cursors
templates for VPB, SVPB, templates for VPB, SVPB, templates for VPB, SVPB,
aberrant SVPB, normal, A- aberrant SVPB, normal, A- aberrant SVPB, normal, A-
paced, V-paced, AV-paced, paced, V-paced, AV-paced, paced, V-paced, AV-paced,
AFib, and artifact beats AFib, and artifact beats AFib, and artifact beats
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS Optional Yes Yes No
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes Yes
ST-segment analysis Yes Yes Yes NA
No. of classifications 37 automatically detected 37 automatically detected 37 automatically detected 37 automatically detected
arrhythmia/rhythm events arrhythmia/rhythm events arrhythmia/rhythm events arrhythmia/rhythm events
PATIENT EVENT STOP Yes Yes Yes Yes
TAPE PLAYBACK TYPE Cassette playback, USB, or Cassette playback, USB, or Cassette playback, USB, or Cassette playback, USB, or
CompactFlash reader CompactFlash reader CompactFlash reader CompactFlash reader
PLAYBACK TYPE
Cassette No No No No
Reel-to-reel No No No No
Digital Yes Yes Yes Yes
PRINTER HP LaserJet 2015, optional HP LaserJet 2015, optional HP LaserJet 2015, optional HP LaserJet 2015, optional
black-and-white or color black-and-white or color black-and-white or color black-and-white or color
LaserJet LaserJet LaserJet LaserJet
REMOTE TRANSMISSION Internet via Internet via Internet via NA
NetScan/NetLink, fax, e- NetScan/NetLink, fax, e- NetScan/NetLink, fax, e-
mail mail mail
PC COMPATIBLE Microsoft Windows Microsoft Windows Microsoft Windows Microsoft Windows
XP/VISTA based XP/VISTA based XP/VISTA based XP/VISTA based
UPGRADEABLE H4W+ software updates H4W+ software updates H4W+ software updates H4W+ software updates
free for the life of the free for the life of the free for the life of the free for the life of the
system/PC system/PC system/PC system/PC
NETWORKABLE Yes Yes Yes Yes

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Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCOTTCARE1 SCOTTCARE1 SCOTTCARE1 SCOTTCARE1


Holter for Windows1+ Holter for Windows2+ Holter for Windows3+ RapidScan+
STORAGE CAPABILITIES
Hard disk 250 GB 250 GB 250 GB 250 GB
Long-term medium DVD, or any PC media DVD, or any PC media DVD, or any PC media DVD, or any PC media
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes Yes
ST-segment deviation Yes Yes Yes NA
Ventricular beats Yes Yes Yes Yes
REPORT OPTIONS
Format PDF for e-mail, fax, Web PDF for e-mail, fax, Web PDF for e-mail, fax, Web PDF for e-mail, fax, Web
Event marker summary Yes Yes Yes Yes
Strip annotation Patient name, time, HR, 2nd Patient name, time, HR, 2nd Patient name, time, HR, 2nd Patient name, time, HR, 2nd
HR, R-R interval, beat-to- HR, R-R interval, beat-to- HR, R-R interval, beat-to- HR, R-R interval, beat-to-
beat HR, strip diagnosis, beat HR, strip diagnosis, beat HR, strip diagnosis, beat HR, strip diagnosis,
standard grid standard grid standard grid standard grid
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Optional Optional Yes NA
Export method Export utility Export utility Export utility Export utility
Export data format HL7, ASCII, PDF HL7, ASCII, PDF HL7, ASCII, PDF, FDA XML HL7, ASCII, PDF
HL7 interfaces V2.3, V3.0 V2.3, V3.0 V2.3, V3.0 V2.3, V3.0
PREFERRED RECORDER Rozinn RZ151 Series Rozinn RZ151 Series Rozinn RZ151 Series Rozinn RZ151 Series
(tape), Rozinn RZ153+ (tape), Rozinn RZ153+ (tape), Rozinn RZ153+ (tape), Rozinn RZ153+
Series (digital) Series (digital) Series (digital) Series (digital)
Accepts others Yes, all 1 mm/sec cassette Yes, all 1 mm/sec cassette Yes, all 1 mm/sec cassette Yes, all 1 mm/sec cassette
WEB-BASED Yes Yes Yes Yes
RESOURCES
Operating system and OS updates from Microsoft, OS updates from Microsoft, OS updates from Microsoft, OS updates from Microsoft,
application H4W+ updates from Rozinn H4W+ updates from Rozinn H4W+ updates from Rozinn H4W+ updates from Rozinn
vulnerabilities
Software patches Yes (MS OS), full release Yes (MS OS), full release Yes (MS OS), full release Yes (MS OS), full release
(H4W+) (H4W+) (H4W+) (H4W+)
PURCHASE
INFORMATION
List price, std Varies with options, Varies with options, Varies with options, Varies with options,
configuration configuration, and quantity configuration, and quantity configuration, and quantity configuration, and quantity
Warranty 3 years 3 years 3 years 3 years
Delivery time, ARO <2 weeks <2 weeks <2 weeks <2 weeks
Year first sold 1993 1993 1993 1996
Number installed
USA/worldwide >4,000 worldwide (all >4,000 worldwide (all >4,000 worldwide (all >4,000 worldwide (all
models) models) models) models)
Fiscal year January to December January to December January to December January to December

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74 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SCOTTCARE1 SCOTTCARE1 SCOTTCARE1 SCOTTCARE1


Holter for Windows1+ Holter for Windows2+ Holter for Windows3+ RapidScan+
OTHER SPECIFICATIONS Fully relational Holter Fully relational Holter Fully relational Holter Network ready; Microsoft
database and archiving; database and archiving; database and archiving; Word; business software;
TRUE 12-lead ECG; TRUE 12-lead ECG; TRUE 12-lead ECG; page and strip editing;
NetScan and NetLink for NetScan and NetLink for NetScan and NetLink for selectable full disclosure; all
Internet 24 hr ECG data Internet 24 hr ECG data Internet 24 hr ECG data Rozinn software products,
transmission; network transmission; network transmission; network including Holter analysis,
ready; Microsoft Word; ready; Microsoft Word; ready; Microsoft Word; transtelephonic monitoring,
business software; FDA business software; FDA business software; FDA and ABP monitoring, may
XML output included with XML output included with XML output included with be installed on same
12-lead option; all Rozinn 12-lead option; all Rozinn 12-lead option; all Rozinn platform or same computer,
software products, including software products, including software products, including if desired.
Holter analysis, Holter analysis, Holter analysis,
transtelephonic monitoring, transtelephonic monitoring, transtelephonic monitoring,
and ABP monitoring, may and ABP monitoring, may and ABP monitoring, may
be installed on same be installed on same be installed on same
platform or same computer, platform or same computer, platform or same computer,
if desired. if desired. if desired.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008 December 2008
Supplier Footnotes 1Formerly Rozinn 1Formerly Rozinn 1Formerly Rozinn 1Formerly Rozinn

Electronics, Inc, acquired by Electronics, Inc, acquired by Electronics, Inc, acquired by Electronics, Inc, acquired by
ScottCare Corp; ScottCare ScottCare Corp; ScottCare ScottCare Corp; ScottCare ScottCare Corp; ScottCare
is a division of Scott is a division of Scott is a division of Scott is a division of Scott
Fetzer/Berkshire Hathaway, Fetzer/Berkshire Hathaway, Fetzer/Berkshire Hathaway, Fetzer/Berkshire Hathaway,
Inc. Inc. Inc. Inc.
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 75


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SHL TELEMEDICINE SPACELABS SPACELABS SPACELABS


HEALTHCARE1 HEALTHCARE1 HEALTHCARE1
CardioVision Software Impresario Ensemble Impresario Solo Impresario Symphony
Analysis
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
HARDWARE/SOFTWARE Not specified Turnkey (hardware) or Turnkey (hardware) or Turnkey (hardware) or
OR SOFTWARE ONLY software only software only software only
SYSTEM TYPE Real-time Retrospective Retrospective Retrospective, prospective
CHANNELS ANALYZED 12 Up to 3 arrhythmia, 3 ST Up to 3 arrhythmia, 3 ST Up to 3 arrhythmia, 3 ST
MAXIMUM NO. OF Not specified Not specified Not specified Not specified
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes Not specified Superimposition, page, Superimposition, page Superimposition,
forms mode, forms arrhythmiagraph, page
Time Yes Yes Yes Yes
Heart rate Yes Yes Yes Yes
Type and size Not specified Not specified Not specified Not specified
FULL DISCLOSURE Yes Yes Yes Yes
PACEMAKER ANALYSIS No Optional Optional Yes
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator No Yes Yes Yes
ST-segment analysis No Yes Yes Yes
No. of classifications 12 Unlimited Unlimited Unlimited
PATIENT EVENT STOP NA Yes Yes Yes
TAPE PLAYBACK TYPE NA Digital flash, digital RAM Digital flash, digital RAM Digital flash, digital RAM
PLAYBACK TYPE
Cassette Not specified No No No
Reel-to-reel Not specified No No No
Digital Not specified Yes Yes Yes
PRINTER Any HP LaserJet HP LaserJet HP LaserJet
REMOTE TRANSMISSION Yes Yes Yes Yes
PC COMPATIBLE Yes Yes Yes Yes
UPGRADEABLE Not specified Yes Yes Yes
NETWORKABLE Not specified Yes Yes Yes

This is the first of three


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

76 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SHL TELEMEDICINE SPACELABS SPACELABS SPACELABS


HEALTHCARE1 HEALTHCARE1 HEALTHCARE1
CardioVision Software Impresario Ensemble Impresario Solo Impresario Symphony
Analysis
STORAGE CAPABILITIES
Hard disk Yes Yes Yes Yes
Long-term medium Hard disk, tape, floppy CD-RW, DVD, network CD-RW, DVD, network CD-RW, DVD, network
Heart rate Yes Yes Yes Yes
TREND GRAPHS
R-R interval No Yes Yes Yes
ST-segment deviation No Yes Yes Yes
Ventricular beats No Yes Yes Yes
REPORT OPTIONS
Format Flexible Flexible user-defined Flexible user-defined Flexible user-defined
Event marker summary Yes Yes Yes Yes
Strip annotation Time, patient name/ID, strip Time, patient name, beat Time, patient name, beat Time, patient name, beat
speed, arrhythmia annotate, annotation, HR, arrhythmia annotation, HR, arrhythmia annotation, HR, arrhythmia
HR, narrative, flexible annotate, speed, scale, annotate, speed, scale, annotate, speed, scale,
narrative narrative narrative
STRIP EXPANSION ON FD Yes Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Yes Yes Yes
Export method Not specified Not specified Not specified Not specified
Export data format Not specified Not specified Not specified Not specified
HL7 interfaces Not specified Yes Yes Yes
PREFERRED RECORDER NA Spacelabs Healthcare Spacelabs Healthcare Spacelabs Healthcare
Lifecard CF, Aria, evo Lifecard CF, Aria, evo Lifecard CF, Aria, evo
Accepts others NA Del Mar 485, 483 Del Mar 485, 483 Del Mar 485, 483
WEB-BASED Not specified Yes Yes Yes
RESOURCES
Operating system and Not specified Windows XP Windows XP Windows XP
application
vulnerabilities
Software patches Not specified Not applicable Not applicable Not applicable
PURCHASE
INFORMATION
List price, std Not specified Not specified Not specified Not specified
configuration
Warranty Not specified 1 year 1 year 1 year
Delivery time, ARO Not specified 30 days 30 days 30 days
Year first sold Not specified 2001 2001 2001
Number installed
USA/worldwide Not specified Not specified Not specified Not specified
Fiscal year Not specified July to June July to June July to June

This is the second of three


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

©2010 ECRI Institute. All Rights Reserved. 77


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SHL TELEMEDICINE SPACELABS SPACELABS SPACELABS


HEALTHCARE1 HEALTHCARE1 HEALTHCARE1
CardioVision Software Impresario Ensemble Impresario Solo Impresario Symphony
Analysis
OTHER SPECIFICATIONS Detailed real-time ECG HRV, QT, and pacemaker Nationwide direct service Late-potential analysis;
waveform; zoom on each of detection optional. support. Meets pacemaker detection; 3
12 leads; point-and-click requirements of ISO 13485. modes for HR annotation;
measurement of ECG QT-segment analysis;
parameters; LAN and stand- event/loop monitoring; ABP;
alone; comparison with nationwide direct service
previous ECG. support. Meets
requirements of ISO 13485.
UMDNS CODE(S) 15295 15295 15295 15295
LAST UPDATED December 2007 December 2008 December 2008 December 2008
Supplier Footnotes 1Acquired Del Mar Reynolds 1Acquired Del Mar Reynolds 1Acquired Del Mar Reynolds

Medical. Medical. Medical.


Model Footnotes
Data Footnotes

78 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SPACELABS SUZUKEN UBS INSTRUMENTS


HEALTHCARE1
Pathfinder DIGITAL Kenz Cardy Analyzer 03 Compas XM
WHERE MARKETED Worldwide Worldwide Worldwide
FDA CLEARANCE Yes No Yes
CE MARK (MDD) Yes Yes Yes
HARDWARE/SOFTWARE Hardware only Not specified Not specified
OR SOFTWARE ONLY
SYSTEM TYPE Retrospective, prospective Prospective, retrospective Real-time
CHANNELS ANALYZED Up to 3 arrhythmia, 3 ST 3 3 simultaneous
MAXIMUM NO. OF Not specified Not specified Not specified
RECORDERS FOR
ANALYSIS AND
STORAGE
SCAN DISPLAY
Scanning modes FD, flowing page, FD, compressed Not specified
superimposition
Time Yes Yes Yes
Heart rate Yes Yes Yes
Type and size Not specified Not specified Not specified
FULL DISCLOSURE Yes Yes Yes
PACEMAKER ANALYSIS Yes Yes No
TOTAL BEATS/BEATS
PER HR
All types Yes/yes Yes/yes Yes/yes
Normal Yes/yes Yes/yes Yes/yes
Ventricular Yes/yes Yes/yes Yes/yes
Supraventricular Yes/yes Yes/yes Yes/yes
ARRHYTHMIA
DETECTION
Indicator Yes Yes Yes
ST-segment analysis Yes Yes Yes
No. of classifications Unlimited Multiple Not specified
PATIENT EVENT STOP Yes Yes Yes
TAPE PLAYBACK TYPE Digital flash card, No None
CompactFlash card
PLAYBACK TYPE
Cassette No No No
Reel-to-reel No No No
Digital Yes Yes Yes
PRINTER HP LaserJet Laser Dot matrix, laser
REMOTE TRANSMISSION Yes No No
PC COMPATIBLE Yes Yes Yes
UPGRADEABLE Yes Not specified Not specified
NETWORKABLE Yes Not specified Not specified

This is the first of three


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

©2010 ECRI Institute. All Rights Reserved. 79


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SPACELABS SUZUKEN UBS INSTRUMENTS


HEALTHCARE1
Pathfinder DIGITAL Kenz Cardy Analyzer 03 Compas XM
STORAGE CAPABILITIES
Hard disk Yes Yes Yes
Long-term medium CD-R/RW, DVD, network Hard disk, F1 optical, MO Not specified
disks, DVD
Heart rate Yes Yes Yes
TREND GRAPHS
R-R interval Yes Yes Yes
ST-segment deviation Yes Yes Yes
Ventricular beats Yes Yes Yes
REPORT OPTIONS
Format 17 flexible formats User-customized Not specified
Event marker summary Yes Yes Yes
Strip annotation Time, event, HR, patient ID, User-customized Yes
beat and event annotate,
analysis date
STRIP EXPANSION ON FD Yes Yes Yes
REPORT
DATA MANAGEMENT Yes Yes Not specified
Export method Not specified Not specified Not specified
Export data format Not specified Not specified Not specified
HL7 interfaces Yes Not specified Not specified
PREFERRED RECORDER Spacelabs Healthcare Kenz Cardy 2P/301 Cardiac Care Units recorder
Lifecard CF
Accepts others Reynolds Medical LC2/3 No Not specified
WEB-BASED Yes Not specified Not specified
RESOURCES
Operating system and Windows XP Not specified Not specified
application
vulnerabilities
Software patches Not applicable Not specified Not specified
PURCHASE
INFORMATION
List price, std Not specified Not specified $3,995
configuration
Warranty 1 year 1 year 1 year
Delivery time, ARO 30 days 1 month Not specified
Year first sold 2000 (Windows 2000 2003 Not specified
version)
Number installed
USA/worldwide Not specified Not specified 5,000
Fiscal year July to June April to March Not specified

This is the second of three


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

80 ©2010 ECRI Institute. All Rights Reserved.


Recorders, Electrocardiography; Scanners, ECG

Chart B: Scanners, Electrocardiography

MODEL SPACELABS SUZUKEN UBS INSTRUMENTS


HEALTHCARE1
Pathfinder DIGITAL Kenz Cardy Analyzer 03 Compas XM
OTHER SPECIFICATIONS 12-lead Holter; 7-day Windows XP-based Narrative summary.
screening; Spectral HRV operation.
option.
UMDNS CODE(S) 15295 15295 15295
LAST UPDATED December 2008 December 2008 December 2008
Supplier Footnotes 1Acquired Del Mar Reynolds

Medical.
Model Footnotes
Data Footnotes

©2010 ECRI Institute. All Rights Reserved. 81

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