Recorders, Electrocardiography Scanners, ECG
Recorders, Electrocardiography Scanners, ECG
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.
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
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
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.
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
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
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
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
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
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
GE HEALTHCARE
GE Healthcare Europe [171319]
283 rue de la Miniere boite postale 34
Buc Cedex F-78533
France
Phone: 33 (1) 30704040 Fax: 33 (1) 30709855
Internet: http://www.gehealthcare.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
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
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
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
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
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
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
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.
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
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Many of the words or model descriptions appearing in the Healthcare Product Comparison System are
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name without designation as proprietary should not be regarded as a representation that is not the subject of
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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
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for the medical device industry.
Medical.
Model Footnotes 1Transtelephonic ECG
transmitter.
Data Footnotes
Medical. Medical.
Model Footnotes
Data Footnotes
These specifications
continue onto the next two
pages.
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
Medical.
Model Footnotes
Data Footnotes