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November 2002

Ultrasound Therapy Systems, Physical Therapy;


Ultrasound Therapy/Neuromuscular
Stimulators, Physical Therapy
a neuromuscular stimulator to enhance pain-relief
Scope of this Product Comparison mechanisms and aid in the healing of soft-tissue injuries.

This Product Comparison covers tabletop, port- The exact physiologic mechanisms of pain relief and
able, and cart- or wall-mounted therapeutic ul- accelerated tissue healing through local heating are
trasound systems and combination ultrasound/ unknown. Possibilities include increased local blood
neuromuscular stimulator systems. Several low- flow, increased local metabolic rate, muscle relaxation,
frequency ultrasound physical therapy systems and heightened pain threshold of nerves. Conditions
are also included in the chart. involving scar-tissue tensions; ulcerations; bursitis; or
muscle, tendon, ligament, or joint pain can be treated
UMDNS information with ultrasonic energy.

This Product Comparison covers the following Similarly, the physiologic mechanisms of pain relief
device terms and product codes as listed in ECRI’s and enhanced tissue healing through nonthermal ef-
Universal Medical Device Nomenclature System™ fects of ultrasound are still under debate. Some theories
(UMDNS™):
• Ultrasound Therapy Systems, Physical
Therapy [11-248]
• Ultrasound Therapy/Neuromuscular Stimula-
tion Systems, Physical Therapy [17-908]

Purpose
Therapeutic ultrasound units convert electromag-
netic energy to high-frequency (i.e., 1 or 3 megahertz
[MHz]) sound waves that penetrate tissues to produce
pain relief and facilitate tissue healing through ther-
mal and nonthermal physiologic reactions. This con-
version of energy occurs in the transducer, or sound or
treatment head, of the machine. Ultrasound as a mo-
dality can be used independently or in conjunction with Portable ultrasound unit

202594 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA


424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org
Healthcare Product Comparison System

propose that the increased release of analgesic chemi- A special coupling gel or water is used to facilitate
cals or increased cell permeability to certain ions is transmission of the ultrasound beam from the
responsible. However, the most widely accepted expla- transducer to the patient’s skin. Some units are water-
nation is acoustic streaming, which occurs in response tight, allowing for underwater therapy. Not using gel
to mechanical pressure, in this case produced by the or water, or using an inadequate amount, will cause
flow of ultrasonic energy. According to this theory, the heat at the transducer-skin interface instead of in the
energy waves produced by the ultrasound transducer underlying tissues, possibly burning the patient.
cause extracellular fluids to move rapidly around the
Most units allow selection of a continuous mode, in
cell membrane, causing the cell to vibrate. The cellular
which the output power is constant, or a pulsed mode,
vibrations produce gas-filled bubbles, a process known
in which the output is switched on and off; the pulse
as cavitation. For therapeutic purposes, the cavitation
rate is typically 60 to 120 pulses per second (pps),
should be stable: the bubbles should pulse but not
although some units operate at a higher or lower rate.
expand or burst. Stable cavitation leads to increased
Pulsed waves are further characterized by the duty
cell permeability, which is believed to induce pain-re-
cycle, the percentage of time that ultrasound waves are
lief mechanisms such as altered pain perceptions. Sta-
present during a pulsed period. Typical duty cycles
ble cavitation is also believed to stimulate the release
range from 5% to 50%. Because the output power of a
of collagen and increase platelet activity, which in turn
pulsed waveform averaged over the on-and-off phase
speeds the rate of healing. Transient cavitation is
of the cycle is lower, it causes less heating than a
unstable and destructive to the cell and may result in
continuous output on the same setting. This means
tissue damage. More research is needed to completely
that the pulsed setting has fewer thermal effects. Some
understand the extent of nonthermal therapeutic ef-
studies have associated a reduced healing time with
fects (Dyson 1987; Michlovitz 1996).
pulsed ultrasound (Dyson 1987).
Principles of operation An important characteristic of the transducer is its
beam nonuniformity ratio (BNR), which approximates
When tissues absorb energy, most of that energy is
the intensity across the transducer’s effective radiat-
converted into heat. Therapeutic ultrasound, a modal-
ing area (ERA) — the actual area of the transducer
ity used in the treatment of soft-tissue injuries, relies
that radiates ultrasound. The BNR is the ratio of the
on a transducer to apply energy to the patient’s skin
maximum point intensity on the transducer to the
in the form of sound waves at frequencies well above
average intensity value across the transducer surface.
those audible to the human ear. A frequency of 1 MHz
Areas of high spatial intensities are known as “hot
is used for deep (3 to 5 cm) tissue, while a frequency of
spots” and may cause excessive heating to the under-
3 MHz is used for more superficial (1 to 2 cm) tissue.
lying tissue. A lower BNR indicates a more even dis-
Ultrasonic energy is gradually absorbed and converted
tribution of energy from the transducer (see Fig. 1).
to heat as it travels through the tissue; therefore, it is
possible to heat the underlying tissue without over- For correct application of ultrasound, the
heating the skin itself. Muscle absorbs about twice as transducer must be kept in constant motion, using
much ultrasonic energy as fat does; bone absorbs about
10 times more than soft tissue does. In traveling
through the first 3 cm of muscle, the ultrasonic beam 100
retains about 50% of its surface intensity value, a
satisfactory amount for deep heating. The rate at 80
Output Intensity, %

which tissue temperature increases when exposed to


the ultrasonic beam depends on the intensity (power 60
per unit area, expressed as watts/cm2) and local circu-
lation, since blood will carry heat away from the area. 40

A therapeutic ultrasound unit has two basic compo- 20


nents — a generator and a transducer. The electrical Center
output of the generator is applied through a flexible 0
C152UN1A

cable to a piezoelectric crystal in the transducer. The 20 15 10 5 0 5 10 15 20


crystal converts electrical energy into acoustic energy 2
Distance from center of 10 cm transducer in mm
through the reverse piezoelectric effect: as the voltage
alternates across the crystal, the crystal expands and Figure 1. Curve of ultrasonic field output across the
contracts, creating vibrations. This acoustic energy transducer’s surface (shown greater than actual scale)
exits the transducer in a collimated beam pattern.

2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

either a stroking motion or an overlapping circular


motion (Gann 1991; Michlovitz 1996). Stationary ap-
plication can lead to a buildup of heat in one spot,
causing a burn to the skin or to deeper tissue. It may
also lead to the formation of standing waves, wherein
the incident wave and the waves reflected from the
tissue interface in the body are superimposed on each
other so the peaks of both waves combine to either
increase the effect or cancel out the waves. Standing
waves can damage the tissues that surround the wave
and may cause clots in smaller blood vessels (Dyson
1987).
Since there is no direct indicator of internal tissue
temperature, the operator depends on patient feed-
back to adjust the intensity of the treatment and
prevent burns. The operator can, however, estimate
the output strength by knowing the ERA, the sound-
wave frequency, and the length of treatment.
Some units have an automatic shutoff that discon-
tinues therapy and stops the unit’s treatment timer
when there is insufficient coupling between the
transducer and the patient; they can also have an
audible and/or visible alarm to alert the user to the
problem. Some units also accommodate the use of two
transducers at a time either to treat two separate areas
on one patient or to treat two patients at once. In
addition, some suppliers offer watertight transducers
for use in underwater therapy. Combined ultrasound unit and neuromuscular
stimulator
A neuromuscular electrical stimulator is electrically
similar to a transcutaneous electrical nerve stimula-
Some neuromuscular stimulators are available as
tion (TENS) unit (see the Product Comparison titled
integral components of therapeutic ultrasound units
STIMULATORS, ELECTROANALGESIC, TRANSCUTANE-
and can be used in conjunction with the ultrasound.
OUS ELECTRICAL NERVE). An electronic generator
Combined therapy has been found to be useful in
transmits pulses of energy through the sound head,
preventing scar tissue formation in healing tissues and
which acts as the active electrode, and into the tissue.
in permitting the user to focus on particular muscle
Pulse waveforms are monophasic (either positive or
trigger points for greater pain relief (Roy and Irvin
negative) or biphasic; typically, a biphasic waveform is
1983). However, there is much controversy about the
used in conjunction with ultrasound therapy. The
validity of these studies, and very little supporting
pulse rate is variable; generally, 80 to 150 pps are used
literature has been published.
therapeutically. The pulse amplitude is adjusted sepa-
rately for each modality, allowing the maximum bene-
fit from both modalities while maintaining patient
Reported problems
comfort.
Ultrasound output may decline over time. The in-
Neuromuscular stimulation produces some local strument should be inspected annually and following
thermal and chemical changes in the patient; however, any mechanical impact to the transducer (e.g., from
it is most often used to create a muscle contraction. dropping) to ensure satisfactory output calibration.
When electrical stimulation is used in conjunction with The transducer assembly is prone to deterioration and
ultrasound, the active electrode can be manipulated to should be checked frequently for proper transmission
produce a rhythmic contraction-release episode in the and watertightness.
muscle or muscle group that is most affected by the
injury. The contraction-release acts as a pump and There have been reports of patient burns during the
promotes the removal of metabolic by-products, which use of ultrasonic units. These include both internal
helps reduce spasm and pain. burns, caused by excess local heating, and skin burns,

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Healthcare Product Comparison System

caused by contact with a hot transducer or heating of Stage of development


the skin-transducer interface due to inadequate gel. Therapeutic ultrasound has been used clinically
The intensity levels of ultrasonic therapy are gener- since the 1940s. Currently, most units are of solid-
ally much higher than those of diagnostic ultrasonic state design with digital controls. In 1993, the U.S.
equipment. Clinicians should therefore be aware of Food and Drug Administration updated its perform-
potential hazards (e.g., areas of insufficient blood flow ance standard for ultrasonic physical therapy prod-
that cannot handle the increased metabolic activity ucts, which requires these units to have a power
caused by ultrasonic treatment) and use ultrasound indicator, an autoshutoff timer, and labels indicating
with care. Inefficient coupling caused by poor design, the BNR and ERA of the transducer. Some manufac-
a defective crystal, or an insufficient amount of gel will turers have also incorporated features such as self-
also cause heat to build up in the transducer and calibration, output power control in response to tissue
thereby reduce the number of sound waves radiated loading, and automatic shutoff in case of an overheated
into the treatment site. transducer and/or inadequate coupling.

Therapeutic ultrasound is contraindicated for use in Studies are being done to evaluate ultrasound use
various areas: the eye; the uterus during pregnancy; in phonophoresis — a method of delivering medica-
the testes; malignant tumors; the spinal cord; and tion through the skin to the site where the effect is
areas over the heart, a pacemaker, joint replacements desired. Although the technique is commonly used,
with polyethylene or methyl methacrylate (a common Byl (1995) concluded that more carefully designed
glue type), prostheses, or epiphyseal (growth) plates in research is needed to improve the ability to provide
patients under the age of 20. In addition, ultrasound effective treatment.
application may damage tissue that has been subjected
to deep radiation treatments. Bibliography
Therapists administering ultrasound treatment are Byl NN. The use of ultrasound as an enhancer for
also exposed to vibrations passed through the housing transcutaneous drug delivery: phonophoresis. Phys
of the transducer as they hold the applicator. These Ther 1995 Jun;75(6):539-53.
vibrations, known as parasitic radiation, may cause
acute pain in the hand and finger joints of some thera- Fletcher D. The fundamentals of ultrasound equip-
pists (Michlovitz 1996). ment. Biomed Inst and Tech 2002 Mar-Apr;
36(2):129-32.

Purchase considerations Gann N. Ultrasound: current concepts. Clin Manage


1991 Jul-Aug;11(4):64-9.
A purchaser has the option of buying a tabletop,
wall-mounted, or cart-mounted therapeutic ultra- Gersh MR. Electrotherapy in rehabilitation. Philadel-
sound unit. Some portable devices are also available in phia: FA Davis; 1992.
a carrying case or tote bag if the unit is to be used for
off-site therapy. Hekkenberg RT, Reibold R, Zeqiri B. Development of
standard measurement methods for essential prop-
Ultrasound units with dual frequencies (i.e., 1 and erties of ultrasound therapy equipment. Ultrasound
3 MHz) provide a greater range of treatment capabili- Med Biol 1994;20(1):83-98.
ties. Some therapy systems come with only one
transducer, while others are equipped with several Michlovitz SL, ed. Thermal agents in rehabilitation.
transducers of various diameters to facilitate treat- 3rd ed. Philadelphia: FA Davis; 1996:168-212.
ment of different areas of the body.
Robinson AJ, Snyder-Mackler L. Clinical electrophysi-
Although ultrasound machines are relatively inex- ology: electrotherapy and electrophysiologic testing.
pensive, costs associated with the following must also 2nd ed. Baltimore (MD): Williams & Wilkins; 1994.
be considered: additional transducers, coupling gel,
service (inspections and repairs), and a therapist. Rothstein J. The rehabilitation specialist’s handbook.
Philadelphia: FA Davis; 1991:627-46.
Instead of buying separate units, purchasers can
obtain a combination ultrasound/neuromuscular Sicard-Rosenbaum L, Lord D, Danoff JV, et al. Effects
stimulator unit to reduce costs. These units allow the of continuous therapeutic ultrasound on growth and
user to choose therapeutic ultrasound only, neuromus- metastasis of subcutaneous murine tumors. Phys
cular stimulation only, or a combination of the two. Ther 1995 Jan;75(1):3-11.

4 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Sussman C. Physical therapy modalities and the TNO Prevention and Health. Development of standard
wound recovery cycle. Ostomy Wound Manage 1992 measurement methods for essential properties of
Mar;38(2):43-51. ultrasound therapy equipment. Ultrasound Med
Biol 1994 Jan;20(1):83-98.
Zeqiri B, Hodnett M. A new method for measuring the
effective radiating area of physiotherapy treatment U.S. Department of Health and Human Services. Food
heads. Ultrasound Med Biol 1998 Jun;24(5):761-70. and Drug Administration. Performance standards for
sonic, infrasonic, and ultrasonic radiation-emitting
Standards and guidelines products. 21 CFR 1050. 2000.

Note: Although every effort is made to ensure that the


following list is comprehensive, please note that other Citations from other ECRI publications
applicable standards may exist.
Health Devices Alerts
British Standards Institution. Specification for safety
of ultrasonic therapy equipment [standard]. BS This Product Comparison lists Health Devices Alerts
5724:Section 2.5. 1985. (HDA) citations published since the last update of this
report. Each HDA abstract is identified by an Acces-
Canadian Healthcare Association. User guidelines for sion Number. Recalls and hazard reports include de-
interferential current therapy devices. H50-1/3- scriptions of the problem involved; abstracts of other
1993E. 1993. published articles are referenced by bibliographic in-
Institute of Physics and Engineering in Medicine. formation. HPCS subscribers can call the Hotline for
Guidelines for the routine performance checking of additional information on any of these citations or to
medical ultrasound equipment. 58. 1988. request more extensive searches of the HDA database.
International Electrotechnical Commission. Medical A4368 The U.K. Medical Devices Agency (MDA) is-
electrical equipment — part 1: general require- sued a safety notice warning that the casing on the
ments for safety [standard]. IEC 60601-1 (1988-12). adapter plug of the Boots the Chemists Item Code
1988. 38-08-920 units purchased in the U.K. in 1999 and 2000
Medical electrical equipment — part 1: general re- break away or totally detach, exposing live wires, with
quirements for safety. Amendment 1 [standard]. the potential to cause electric shock to users. MDA
IEC 60601-1-am1 (1991-11). 1991. recommends the following: (1) Identify and isolate any
affected product purchased in 1999 or 2000. (2) Discon-
Medical electrical equipment — part 1: general re- tinue use of affected product, immediately switch the
quirements for safety. Amendment 2 [standard]. power off at the main power supply, and remove the
IEC 60601-1-am2 (1995-03). 1995. adapter plug from the main socket. (3) Return affected
Medical electrical equipment — part 1: general re- product to the nearest Boots the Chemists outlet for
quirements for safety. Section 1. Collateral stan- refund, repair, or replacement. Healthcare profession-
dard: safety requirements for medical electrical als who become aware that their patients or clients are
systems. IEC 60601-1-1 (1992-06). 1992. using these devices should warn them about the poten-
tial problem and advise them to take the above actions.
Medical electrical equipment — part 1: general re-
For further information, contact Paul Tansley, Boots
quirements for safety. Section 1. Collateral stan-
Company PLC, by mail at the above address, by tele-
dard: safety requirements for medical electrical
phone at (0115) 949 2218, or by fax at (0115) 847 2825.
systems. Amendment 1. IEC 60601-1-1-am1 (1995-
Inquiries to MDA should be addressed to the MDA
11). 1995.
Adverse Incident Centre by mail at Hannibal House,
Medical electrical equipment — part 1: general re- Elephant and Castle, London SE1 6TQ, England; by
quirements for safety. Section 2. Collateral standard: telephone at (0207) 972 8080; or by fax at (0207) 972
electromagnetic compatibility — requirements and 8109. Source: Great Britain. Medical Devices Agency.
tests. IEC 60601-1-2 (2001-09). 2001. Product recall: Boots pain therapy intrasound unit,
Medical electrical equipment — part 2-5: particular item code 38-08-920. London: Department of Health;
requirements for the safety of ultrasonic therapy 2001 Mar. 3 p. (Safety notice; no. SN2001[05])
equipment. 2nd ed [standard]. IEC 60601-2-5 (2000-
Health Devices Inspection and Preventive Maintenance
07). 1984 (revised 2000).
System
Testing and calibration of ultrasonic therapeutic
equipment [standard]. 150. 1963. Physical therapy ultrasound units. Procedure no. 470.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 5
Healthcare Product Comparison System

Supplier information Diter-Elektroniikka


Diter-Elektroniikka Oy [172848]
Amrex Hakkiskuja 10
FIN-20300 Turku
Amrex Electrotherapy Equipment [178844]
Finland
641 E Walnut St
Phone: 358 (2) 2539800
Carson CA 90746-1227
Fax: 358 (2) 2384504
Phone: (310) 527-6868, (800) 221-9069
E-mail: mail@diter.com
Fax: (310) 366-7343
Internet: http://www.diter.com
E-mail: amrex@amrex-zetron.com
Internet: http://www.amrex-zetron.com
Dynatronics
Bandelin Electronic Dynatronics [105329]
7030 Park Centre Dr
Bandelin Electronic GmbH & Co KG [173102]
Salt Lake City UT 84121
Heinrichstrasse 3-4
Phone: (801) 568-7000, (800) 874-6251
D-12207 Berlin
Fax: (801) 568-7711
Germany
E-mail: info@dynatron.com
Phone: 49 (30) 768800
Internet: http://www.dynatronics.com
Fax: 49 (30) 7734699
E-mail: info@bandelin.com
Internet: http://www.bandelin.com DynaWave
DynaWave Corp [102810]
Biorem 2520 Kaneville Ct
Biorem Physiotherapy [192812] Geneva IL 60134-2506
via F Angrisani 18/A Phone: (630) 232-4945
I-84043 Agropoli SA Fax: (630) 232-7042
Italy E-mail: dynawave@inil.com
Phone: 39 (0974) 827171 Internet: http://www.inil.com/users/dynawave
Fax: 39 (0974) 824246
Internet: http://www.bsbgroup.it
Electro-Medical
Electro-Medical Supplies (Greenham) Ltd
Celcom
[171326]
Celcom Inc [277920] Limborough Road
2-2-13 Tokoji-machi Wantage, Oxfordshire OX12 7AD
Hakata-ku England
Fukuoka 816-0096 Phone: 44 (1235) 772272
Japan Fax: 44 (1235) 763518
Phone: 81 (92) 4718863 E-mail: sales@emslimited.co.uk
E-mail: celcom00@db3.so-net.no.jp Internet: http://www.emslimited.co.uk

Chattanooga Electromedicarin
Chattanooga Group Electromedicarin SA [230811]
Div Encore Medical Corp [101154] Poligono Industrial Can Volart
4717 Adams Rd Calle Torre de Cellers 6 Nave 2
PO Box 489 E-08150 Parets del Valles (Barcelona)
Hixson TN 37343-4001 Spain
Phone: (423) 870-2281, (800) 592-7329 Phone: 34 (93) 5730724
Fax: (423) 875-5497 Fax: 34 (93) 5730331
E-mail: customerservice@chattgroup.com E-mail: carin@electromedicarin.com
Internet: http://www.chattgroup.com Internet: http://www.electromedicarin.com

6 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Elmed ERBE Elektromedizin

Elmed Inc [101348] ERBE Elektromedizin GmbH [156988]


60 W Fay Ave Waldhoernlestrasse 17
Addison IL 60101-5106 D-72072 Tuebingen
Phone: (630) 543-2792 Germany
Fax: (630) 543-2102 Phone: 49 (7071) 7550
E-mail: medical@elmed.com Fax: 49 (7071) 755179
Internet: http://www.elmed.com E-mail: sales@erbe-med.de
Internet: http://www.erbe-med.de

Hero Medical
Enraf-Nonius Hero Medical Pty Ltd [177031]
PO Box 441
Enraf-Nonius bv [295028] Elwood
Roentgenweg 1 Melbourne, VIC 3184
Postbus 810 Australia
NL-2600 AV Delft Phone: 61 (3) 95318788
The Netherlands Fax: 61 (3) 95318788
Phone: 31 (15) 2698400 E-mail: sales@hero.com.au
Fax: 31 (15) 2561686 Internet: http://www.hero.com.au
E-mail: info@enraf-nonius.nl
Internet: http://www.enraf-nonius.com
Innokas Medical
Enraf-Nonius Medical Equipment Co Ltd
[303456] Innokas Medical Oy [330829]
984/22-27 TSST Building Tarjusojantie 10
Sukhumvit 71 Road Klongton Nua Wattana FIN-90440 Kempele
Bangkok 10110 Finland
Thailand Phone: 358 (8) 5623100
Phone: 66 (2) 7133366 Fax: 358 (8) 5623111
Fax: 66 (2) 7132145 E-mail: innokas@innokasmedical.fi
E-mail: prasrai@mozart.inet.co.th Internet: http://www.innokasmedical.fi
Internet: http://www.enraf-nonius.com

Enraf-Nonius NV/SA [333675] ITO


Ingberthoeveweg 3d ITO Co Ltd [156029]
B-2630 Aartselaar 3-3-3 Toyotama-Minami
Belgium Nerima-ku
Phone: 32 (3) 4500070 Tokyo 176-8605
Fax: 32 (3) 4500075 Japan
E-mail: info@enraf-nonius.be Phone: 81 (3) 39944619
Internet: http://www.enraf-nonius.com Fax: 81 (3) 39941465
E-mail: itocoltd@itolator.co.jp
Enraf-Nonius SA [333676] Internet: http://www.itolator.co.jp
15 rue Paul Langevin
Zone d’Activites les Beaudottes ITO JV International (S) Pte Ltd [173130]
F-93274 Sevran Cedex 63 Hillview Avenue
France 07-20 Lam Soon Industrial Building
Phone: 33 (1) 49361818 Singapore 669569
Fax: 33 (1) 43847649 Republic of Singapore
E-mail: info@enraf-nonius.fr Phone: 65 7638233
Internet: http://www.enraf-nonius.com Fax: 65 7638200

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

KLD-Biosistemas Mettler Electronics


KLD-Biosistemas Equipamentos Eletronicos Ltda Mettler Electronics Corp [101504]
[174395] 1333 S Claudina St
Avenida Europa 610 Jd Camanducaia Anaheim CA 92805-6235
Caixa Postal 140 Phone: (714) 533-2221, (800) 854-9305
13900-909 Amparo-SP Fax: (714) 635-7539
Brazil E-mail: mail@mettlerelec.com
Phone: 55 (19) 38079811 Internet: http://www.mettlerelec.com
Fax: 55 (19) 38079812
E-mail: kld@wayout.com
Internet: http://www.kld.com Nemectron

KW Industria Nemectron GmbH [138326]


Daimler Strasse 15
KW Eletronica Ltda [174401]
D-76185 Karlsruhe
Avenida Augusto Barassa 1211
Germany
Juliana
Phone: 49 (721) 97320
13904-990 Amparo-SP
Fax: 49 (721) 9732175
Brazil
E-mail: export@nemectron.de
Phone: 55 (19) 38075100
Internet: http://www.nemectron.de
Fax: 55 (19) 38076774
E-mail: kw@kweletronica.com
Internet: http://www.kweletronica.com
Physiomed

Laser Instruments Physiomed Electromedizin AG [285969]


CTL-Laserinstruments [416026] Postfach 48
ulica Wiosny Ludow 49 D-91218 Schnaittach/Laipersdorf
PL-02-495 Warszawa Germany
Poland Phone: 49 (9126) 258720
Phone: 48 (22) 8678801 Fax: 49 (9126) 258725
Fax: 48 (22) 8678748 E-mail: info@physiomed.de
E-mail: pokora@ctl.com.pl Internet: http://www.physiomed.de
Internet: http://www.ctl.com.pl

Rich-Mar
Metrax
Metrax GmbH [172393] Rich-Mar Corp [101645]
Reinwaldstrasse 22 PO Box 879
D-78682 Rottweil Inola OK 74036-0879
Germany Phone: (918) 543-2222, (800) 762-4665
Phone: 49 (741) 2570 Fax: (918) 543-3334
Fax: 49 (741) 257235 E-mail: info@richmarweb.com
E-mail: metrax.vertrieb@metrax.de Internet: http://www.richmarweb.com
Internet: http://www.metrax.de

Metron Skylark

Metron Medical Australia Pty Ltd [184653] Skylark Device & Systems Co Ltd [152424]
57 Aster Avenue 12/Fl No 34 Chung Shan North Road Section 3
PO Box 2164 Taipei
Carrum Downs, VIC 3201 Taiwan
Australia Phone: 886 (2) 25979005
Phone: 61 (3) 97751234 Fax: 886 (2) 25912344
Fax: 61 (3) 97751990 E-mail: skylark@ms1.hinet.net
E-mail: mmasales@zip.com.au Internet: http://www.skylarkdevice.com

8 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

TRUMPF Zimmer
Zimmer Electromedical Corp [243015]
TRUMPF Medizin Systeme & Co KG [407177]
25 Mauchly Suite 300
Am Gansacker 1b
Irvine CA 92618-2331
D-79224 Umkirch
Phone: (949) 727-3356, (800) 327-3576
Germany
Fax: (949) 727-2154
Phone: 49 (7665) 98020
E-mail: info@zimmerusa.com
Fax: 49 (7665) 980237
Internet: http://www.zimmerusa.com
E-mail: info.em@de.trumpf-med.com
Internet: http://www.trumpf-med.com Zimmer Elektromedizin GmbH [232380]
Junkersstrasse 9
D-89231 Neu-Ulm
TUR Germany
Phone: 49 (731) 9761291
TUR Elektromedizin GmbH [283034] Fax: 49 (731) 9761299
Berliner Strasse 60 E-mail: info@zimmer.de
D-16540 Hohen Neuendorf Internet: http://www.zimmer.de
Germany
Note: The following companies did not provide us
Phone: 49 (3303) 5260
with any product information in time for publication.
Fax: 49 (3303) 52612
Their addresses are listed as a service to our readers.
E-mail: tur@elektromedizin.com
Internet: http://www.elektromedizin.com Cosmogamma srl [152467]
via Govoni 8/A
I-40066 Pieve di Cento BO
Uniphy Italy
Phone: 39 (051) 975054
GymnaUniphy NV [394679] Internet: http://www.cosmogamma.com
Pasweg 6a R J Lindquist Co [102114]
B-3740 Bilzen 2419 W 9th St
Belgium Los Angeles CA 90006-2004
Phone: 32 (89) 510510 Phone: (213) 382-1268
Fax: 32 (89) 510511 Fax: (213) 382-0958
E-mail: info@gymna-uniphy.com
Internet: http://www.gymna-uniphy.com
About the chart specifications
The following terms are used in the chart:
XLTEK Maximum output, W: The maximum ultrasonic energy
radiated by the transducer, expressed in watts.
XLTEK [375502]
2568 Bristol Circle Maximum intensity, W/cm2: The maximum energy ra-
Oakville ON L6H 5S1 diated per unit area, expressed in watts per square
Canada centimeter.
Phone: (905) 829-5300, (800) 387-7516
Duty cycle, %: The pulse duration (time on) divided by
Fax: (905) 829-5304
the entire pulse period (time on + time off).
E-mail: diagnostic_sales@xltek.com
Internet: http://www.xltek.com Pulse rate, pps: The repetition frequency of waves,
expressed in pulses per second.
XLTEK Korea Co Ltd [266253]
BNR: The beam nonuniformity ratio, or ratio of the
Kangnam-gu Do-Kok Gong 951-33
maximum to average intensity across the
So-Hun Building No 202
transducer surface; a lower number indicates more
Seoul 101-752
uniform output from the transducer.
Republic of Korea
Phone: 82 (2) 5382443 Transducer, number: The number of transducers avail-
E-mail: diagnostic_sales@xltek.com able; one transducer is included in the price, and the
Internet: http://www.xltek.com others are optional.

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

ERA, cm2: The effective radiating area of the MDD — Medical Devices Directive
transducer, expressed in square centimeters.
Ni-Cd — Nickel-cadmium
Multifrequency capability: The ability of a dual-
frequency unit’s transducer to emit both frequen- SEV — Schweizerischer Electrotechnischer Verein
cies through the same treatment head. TENS — Transcutaneous electrical nerve stimulation
Plug-in/hardwired: The transducer is either perma-
nently wired or simply plugged into the unit. TUV — Technischer Ueberwachungs Verein

Abbreviations: UL — Underwriters Laboratories

CE — Communaute Europeen VDE — Verband Deutscher Electrotechniker

CE mark — Conformite Europeene mark VGA — Video graphics array

CETL — Canadian ETL Testing Laboratories Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
CISPR — Comite International Special des Pertur- independent testing by ECRI or any other agency.
bations Radioelectriques Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, prod-
CSA — Canadian Standards Association
ucts and specifications are subject to frequent changes.
CUL — Canadian Underwriters Laboratories ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
EEC — European Economic Community quences of acting on such information.
EN — European Norm When reading the charts, keep in mind that, unless
ETL — ETL Testing Laboratories otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which
EU — European Union features and characteristics are standard and which
are not, some may be optional, at additional cost.
FCC — U.S. Federal Communications Commission
For those models whose prices were supplied to us
FDA — U.S. Food and Drug Administration in currencies other than U.S. dollars, we have also
GS — Gepruefte Sicherheit listed the conversion to U.S. dollars to facilitate com-
parison among models. However, keep in mind that
IEC — International Electrotechnical Commission exchange rates change often.
ISO — International Organization for Standardi- Need to know more?
zation For further information about the contents of this
LCD — Liquid crystal display Product Comparison, contact the HPCS Hotline at +1
(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
LED — Light-emitting diode hpcs@ecri.org (e-mail).

10 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL AMREX AMREX AMREX BANDELIN ELECTRONIC

SYNCHROSONIC SYNCHROSONIC SYNCHROSONIC UltraPuls H


U/20 : U/50 U/HVG50 : US/752 US/50 : US/54
WHERE MARKETED Worldwide Worldwide Worldwide European Union

FDA CLEARANCE Yes Yes Yes No


CE MARK (MDD) Not specified Not specified Not specified Yes
CONFIGURATION Portable Portable Portable Tabletop

OUTPUT
Frequency, MHz 1 1 1 0.043
Maximum output, W 12 : 20 (optional 12 20 (optional 12 for 20 (optional 12 for 16
for export) export) export)
Maximum intensity,
W/cm2 5 (opt 3 for export) 5 (opt 3 for export) 5 (opt 3 for export) 0.15

Continuous beam Yes (100% amplitude) * Yes (100% amplitude) * Yes (100% amplitude) * Yes
Pulsed beam Yes Yes Yes Yes
Duty cycle, % 100 : 50 50 50 75

Pulse rate, pps NA : 0.29-0.67 0.29-0.67 0.29-0.67 Not specified


BNR 5.5:1 maximum 5.5:1 maximum 5.5:1 maximum Not specified

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Analog Analog Analog LED

TRANSDUCER
Number 1 1 1 1
ERA, cm2 4 4 4 20
Multifrequency
capability No No No No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No : Optional, with Yes Yes No
external stimulator
POWER SOURCE, VAC 120/220 120/220 120/220 240
Hz 50/60 50/60 50/60 50
H x W x D, cm (in) 17.8 x 30.5 x 27.9 17.8 x 50.8 x 27.9 17.8 x 38.1 x 27.9 12.5 x 24 x 18.5
(7 x 12 x 11) (7 x 20 x 11) (7 x 15 x 11) (4.9 x 9.4 x 7.3)
WEIGHT, kg (lb) 5.4 (12) 8.2 (18) : 9.1 (20) 6.4 (14) 2.3 (5.1)
LIST PRICE $1,095 : $1,535 $3,625 : $2,965 $2,035 : $2,310 Not specified

WARRANTY 2 years 2 years 2 years 2 years

DELIVERY TIME, ARO Not specified Not specified Not specified Not specified
YEAR FIRST SOLD Not specified Not specified Not specified 2000
FISCAL YEAR March to February March to February March to February January to December
OTHER SPECIFICATIONS Watertight sound Watertight sound Watertight sound Application for
head; wall bracket, head; wall bracket, head; wall bracket, wound cleaning and
utility cart, quick- utility cart, quick- utility cart, quick- healing stimulation;
connect transducer connect transducer connect transducer transducer designed
cable optional; cable optional; cable optional; to be waterproof
standard and small standard and small standard and small (IP 67).
transducer face- transducer face- transducer face-
plates available. plates available. plates available.
CSA approved and CSA approved. CSA approved.
UL listed.

Colons separate data on similar models of a device.


* Modulated at 120 Hz.

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

Product Comparison Chart


MODEL BANDELIN ELECTRONIC BIOREM BIOREM CELCOM
FAILED TO RESPOND * FAILED TO RESPOND * FAILED TO RESPOND *
UltraPuls R ECO ECOSCAN UX-301

WHERE MARKETED European Union Worldwide Worldwide Worldwide

FDA CLEARANCE No No No No
CE MARK (MDD) Yes Yes Yes No
CONFIGURATION Tabletop Tabletop, portable, Tabletop, portable, Tabletop
cart cart
OUTPUT
Frequency, MHz 0.068 1, 3 1, 3 1
Maximum output, W 6 10 cont, 15 pulsed 10 cont, 15 pulsed 5

Maximum intensity,
W/cm2 0.5 2 cont, 3 pulsed 2 cont, 3 pulsed Not specified

Continuous beam No Yes Yes Not specified


Pulsed beam Yes Yes Yes Not specified
Duty cycle, % 60 25, 50, 75, cont 25, 50, 75, cont Not specified
(@ 0.5 Hz) (@ 0.5 Hz)
Pulse rate, pps Not specified 1/2, 1/4, 1/9 (2 ms) 1/2, 1/4, 1/9 (2 ms) Not specified
BNR Not specified <6 <6 Not specified

TIMER RANGE, min 0-8 0-30 0-30 0-30


OUTPUT POWER DISPLAY LED Digital Digital Not specified

TRANSDUCER
Number 1 1 3 Not specified
ERA, cm2 3 5 5, 50 Not specified
Multifrequency
capability No Yes Yes Not specified
Plug-in/hardwired Plug-in Plug-in Plug-in Not specified
NEUROMUSCULAR
STIMULATOR No Optional Optional Yes

POWER SOURCE, VAC 240 100/240 100/240 100-240


Hz 50 50/60 50/60 50/60
H x W x D, cm (in) 25.6 x 25 x 15.4 32 x 30 x 12 45 x 34 x 15 28 x 36 x 14
(10 x 9.8 x 6.1) (12.6 x 12 x 4.7) (18 x 13 x 6) (11 x 14.2 x 5.5)
WEIGHT, kg (lb) 2.2 (4.5) 2.7 (5.9) 5.5 (12) 5 (11)
LIST PRICE Not specified ITL 942,065-1,151, See footnote ** Not specified
385 (US$452-552)
WARRANTY 2 years 1 year 1 year 1 year

DELIVERY TIME, ARO Not specified 2 weeks 2 weeks 2 weeks


YEAR FIRST SOLD 2001 1993 1993 Not specified
FISCAL YEAR January to December Not specified Not specified October to September
OTHER SPECIFICATIONS Treatment of Autocalibration; 2 special None specified.
musculoskeletal contact control; applicators with
disorders; tranducer autodiagnosis. wide control
designed to be surfaces; can be
waterproof (IP 67). applied in a fixed
way with common
elastic bandages;
autocalibration;
contact control;
autodiagnosis.

Colons separate data on similar models of a device.


* Specifications current as of April 2001.
** ITL 1,537,018-1,878,586 (US$856-1,046).

12 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL CHATTANOOGA CHATTANOOGA CHATTANOOGA CHATTANOOGA

Forte CPS 200 Combo Forte CPS Ultrasound Intelect 200 Intelect 300
: CPS 400 Combo Ultrasound Ultrasound
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) Not specified Not specified Yes Yes
CONFIGURATION Portable/cart Portable/cart/ Portable Portable
battery option
OUTPUT
Frequency, MHz 1, 3.3 1, 3.3 1, 3.3 1, 3.3
Maximum output, W 20 20 20 20

Maximum intensity,
W/cm2 2.5 2.5 2.5 2.5

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100

Pulse rate, pps 100 100 100 100


BNR <6 <6 <6 <6

TIMER RANGE, min 0-99 0-99 0-99 0-99


OUTPUT POWER DISPLAY LCD/digital LED LCD Digital LED LCD

TRANSDUCER
Number 3 3 3 3
ERA, cm2 2, 5, 10 2, 5, 10 2, 5, 10 2, 5, 10
Multifrequency
capability Yes Yes Yes Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes Output jack Output jack Output jack

POWER SOURCE, VAC 90-260 90-260 90-260 90-260


Hz 47/63 47/63 47/67 47/67
H x W x D, cm (in) 14 x 12 x 4 21 x 28 x 6.4 21 x 28 x 8.9 21 x 28 x 6.4
(5.5 x 4.7 x 1.6) (8.3 x 11 x 2.5) (8.3 x 11 x 3.5) (8.3 x 11 x 2.5)
WEIGHT, kg (lb) 1.6 (3.5) 0.9 (2) w/o battery 0.9 (2) w/o battery 0.9 (2) w/o battery
LIST PRICE $3,295 : $3,895 $1,695 $1,525 $1,585

WARRANTY 2 years, limited 2 years, limited 2 years 2 years

DELIVERY TIME, ARO <30 days <30 days <30 days <30 days
YEAR FIRST SOLD 1997 1997 1998 1998
FISCAL YEAR June to May June to May June to May June to May
OTHER SPECIFICATIONS BNR certificate; Optional recharge- Self-calibrating Self-calibrating
self-calibrating able Ni-Cd ultrasound; head ultrasound; head
ultrasound; built-in batteries; self- contact control. contact control;
clinical protocols calibrating built-in clinical
and remote control. ultrasound; built-in protocols.
clinical protocols.

Colons separate data on similar models of a device.

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

Product Comparison Chart


MODEL CHATTANOOGA CHATTANOOGA CHATTANOOGA CHATTANOOGA

Intelect 340 Combo Intelect Legend Intelect Legend Vectra 2C :


Combo Ultrasound Vectra 4C
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) Yes Not specified Not specified Not specified
CONFIGURATION Portable/cart Portable/cart Portable/cart Portable/cart

OUTPUT
Frequency, MHz 1, 3.3 1, 3.3 1, 3.3 1, 3.3
Maximum output, W 20 20 20 20

Maximum intensity,
W/cm2 2.5 2.5 2.5 2.5

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100

Pulse rate, pps 16, 48, 100 100 100 100


BNR <6 <6 <6 <6

TIMER RANGE, min 0-99 0-99 0-99 0-99


OUTPUT POWER DISPLAY LCD/digital LED LCD/digital LED Electroluminescent Electroluminescent

TRANSDUCER
Number 3 3 3 3
ERA, cm2 2, 5, 10 2, 5, 10 2, 5, 10 2, 5, 10
Multifrequency
capability Yes Yes Yes Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes Yes Output jack Yes

POWER SOURCE, VAC 90-260 90-260 90-260 90-260


Hz 47/63 47/63 47/63 47/63
H x W x D, cm (in) 14 x 12 x 4 14 x 12 x 4 21 x 28 x 8.9 40.6 x 54.6 x 20.3
(5.5 x 4.7 x 1.6) (5.5 x 4.7 x 1.6) (8.3 x 11 x 3.5) (16 x 21.5 x 8)
WEIGHT, kg (lb) 1.6 (3.5) 1.6 (3.5) 0.9 (2) 5.9 (13)
LIST PRICE $2,395 $2,995-3,295 $1,595 $4,595 : $5,295

WARRANTY 2 years 2 years 2 years 2 years

DELIVERY TIME, ARO <30 days <30 days <30 days <30 days
YEAR FIRST SOLD 1998 1999 1997 1999
FISCAL YEAR June to May June to May June to May June to May
OTHER SPECIFICATIONS Self-calibrating Self-calibrating Self-calibrating Self-calibrating
ultrasound; head ultrasound. ultrasound. ultrasound; gel
contact control; warmer; built-in
built-in clinical clinical protocols.
protocols; remote
control included.

Colons separate data on similar models of a device.

14 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL CHATTANOOGA DITER-ELEKTRONIIKKA DYNATRONICS DYNATRONICS

Vectra Pro 2 : D1 ULTRA : D1b UL- Dynatron 150 Plus Dynatron 850 Plus :
Vectra Pro 4 : TRA : D4 COMBI 950 Plus
WHERE MARKETED Worldwide Europe, Far East, Worldwide Worldwide
Middle East

FDA CLEARANCE Yes Not specified Yes Yes


CE MARK (MDD) No Yes Yes Yes
CONFIGURATION Cart included Tabletop Portable Portable

OUTPUT
Frequency, MHz 1, 3.3 0.9, 2, 3 1, 2, 3 1, 2, 3
Maximum output, W 20 9 continuous, 12 20 20
pulsed
Maximum intensity,
W/cm2 2.5 2 20 20

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50, 100 Not specified 10, 20, 50, continu- 10, 20, 50, continu-
ous ous
Pulse rate, pps 100 16, 48, 100 100 100
BNR <6 Not specified <6 <6

TIMER RANGE, min 0-99 0-30 0-99 0-99


OUTPUT POWER DISPLAY Color VGA Not specified Digital Digital
touchscreen
TRANSDUCER
Number 3 1 Up to 4 Up to 4
ERA, cm2 2, 5, 10 6; 1.3 optional 1, 2, 5, 10 1, 2, 5, 10
Multifrequency
capability Yes Yes 1, 2, 3 MHz 1, 2, 3 MHz
Plug-in/hardwired Plug-in Not specified Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes Not specified Possible with Yes
interconnection
POWER SOURCE, VAC 90-260 110-120/220-240 120/240 120/240
Hz 47/63 50/60 50/60 50/60
H x W x D, cm (in) 40.6 x 54.6 x 20.3 33 x 31 x 14 8.9 x 20.3 x 17.8 8.4 x 25.4 x 24.1
(16 x 21.5 x 8) (13 x 12.2 x 5.5) (3.5 x 8 x 7) (3.3 x 10 x 9.5)
WEIGHT, kg (lb) 5.9 (13) 5.5 (12.1) <1.8 (<4) 2.1 (4.6)
LIST PRICE $6,195 : $7,295 Not specified $1,495 $2,995 : $4,195

WARRANTY 2 years Not specified 2 years 2 years

DELIVERY TIME, ARO <30 days Not specified Not specified Not specified
YEAR FIRST SOLD 1999 1999 Not specified Not specified
FISCAL YEAR June to May Not specified July to June July to June
OTHER SPECIFICATIONS Self-calibrating Multifrequency; Parameters can be Parameters can be
ultrasound; gel microprocessor; modified during modified during
warmer; built-in sealed for treatment; water- treatment; water-
clinical protocols; underwater therapy. tight sound heads; tight sound heads;
multimedia; includes sound-head sound-head protec-
2 soundheads and all protection system; tion system; option-
probes. optional carrying al carrying case;
case. Complies with stimulator includes
CSA and FCC Part 18 interferential and
verification. combination therapy.

Colons separate data on similar models of a device.

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

Product Comparison Chart


MODEL DYNAWAVE DYNAWAVE DYNAWAVE DYNAWAVE

DynaLator 811 DynaSound 401 DynaSound 801 Soundtek UT-4700

WHERE MARKETED USA USA USA USA

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) No No No No
CONFIGURATION Tabletop Tabletop Tabletop Portable

OUTPUT
Frequency, MHz 1 1 1 1
Maximum output, W 20 20 20 16 cont, 20 pulsed

Maximum intensity,
W/cm2 2 2 2 2 cont, 2.5 pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 5-50 25, 50, 75 5-50 20

Pulse rate, pps 10 30 10 10


BNR 4.8 8 7.5 8

TIMER RANGE, min 0-99 0-99 0-99.9 0-15


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 1 1 1 1
ERA, cm2 10 * 10 * 10 * 8
Multifrequency
capability No No No No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes No No Yes

POWER SOURCE, VAC 115 ** 115 115 ** 115


Hz 50/60 60 50/60 60
H x W x D, cm (in) 14.6 x 43.2 x 33 12.7 x 27.9 x 33 14.6 x 43.2 x 33 15.9 x 32 x 23.9
(5.8 x 17 x 13) (5 x 11 x 13) (5.8 x 17 x 13) (6.3 x 12.6 x 9.4)
WEIGHT, kg (lb) 8.2 (18) 4.5 (10) 8.2 (18) 8.4 (18.5)
LIST PRICE $5,195 $4,495 $2,995 $2,495

WARRANTY 2 years 2 years 2 years 1 year

DELIVERY TIME, ARO Stock Stock Stock Stock


YEAR FIRST SOLD Not specified Not specified Not specified Not specified
FISCAL YEAR October to September October to September October to September October to September
OTHER SPECIFICATIONS Audiovisual Constant power Audiovisual Optional mobile
indicator for output regardless indicator for cart.
open/short circuit, of tissue density; open/short circuit,
overheated, or automatic treatment overheated, or
detuned transducer; suspension for detuned transducer;
includes constant inadequate coupling; constant power
power output audiovisual coupling output regardless of
regardless of tissue indicator; self-test tissue density.
density. capability.

Colons separate data on similar models of a device.


* A 5 cm2 transducer can be substituted for the 10 cm2 transducer at no charge.
** Others available.

16 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL ELECTRO-MEDICAL ELECTRO-MEDICAL ELECTRO-MEDICAL ELECTROMEDICARIN

Combination 850 EMS 350 : EMS 450 MEDI-LINK Ultrasound Megasonic 212-K

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Not specified Not specified Not specified No


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Portable Portable Portable Tabletop

OUTPUT
Frequency, MHz 1, 3 1 or 3 : 1, 3 1, 3 1
Maximum output, W 10 10 10 15

Maximum intensity,
W/cm2 2 2 2 2.5 cont/pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % Not specified Not specified Not specified 10, 20

Pulse rate, pps Not specified Not specified Not specified 100%
BNR 6 6 6 <6

TIMER RANGE, min 0-20 0-20 0-20 0-30


OUTPUT POWER DISPLAY Digital LCD Digital LED Digital LCD * 12 LEDs

TRANSDUCER
Number 2 1:2 2 1
ERA, cm2 0.5, 5 5 : 0.5, 5 0.5, 5 6
Multifrequency
capability Yes No : Yes Yes No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in (3)
NEUROMUSCULAR
STIMULATOR 2/4 pole No Optional No
interferential
POWER SOURCE, VAC 100/240 100/240 100/240 110/220
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) Not specified Not specified Not specified 9 x 25 x 28
(3.5 x 9.8 x 10.9)
WEIGHT, kg (lb) 2.2 (4.9) 1.5 (3.3) 1 (2.2) 7 (15.4)
LIST PRICE £1,595 (US$2,360) £575 (US$903) : £485 (US$761) $1,500
£895 (US$1,324)
WARRANTY 2 years 2 years 2 years Not specified

DELIVERY TIME, ARO 7-10 days 7-10 days 7-10 days 1 month
YEAR FIRST SOLD 1999 1994 1994 1996
FISCAL YEAR April to March April to March April to March Not specified
OTHER SPECIFICATIONS Line power and None specified. Requires control Microprocessor self-
battery. module (ML9000, calibration test;
£699 [US$1,034]) watertight sound
plus a treatment head; ultrasound
head (ML9120 or feedback contact
ML9130, control; micro-
£475 [US$703] processor self-
each). calibration head.
ISO 9001 and 46001.

Colons separate data on similar models of a device.


* On control module.

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

Product Comparison Chart


MODEL ELECTROMEDICARIN ELECTROMEDICARIN ELECTROMEDICARIN ELECTROMEDICARIN

Megasonic 212-P Megasonic 226 Megasonic 700 Megasonic 707

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE No No No No
CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Portable Tabletop Tabletop Tabletop

OUTPUT
Frequency, MHz 1 1 1, 3 1, 3
Maximum output, W 15 15 15 15

Maximum intensity,
W/cm2 2.5 cont/pulsed 2.5 cont/pulsed 2.5 cont/pulsed 2.5 cont/pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20 10, 20 10, 20 10, 20

Pulse rate, pps 100% 100% 100% 100%


BNR <6 <6 <6 <6

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY 12 LEDs Digital LCD Digital LCD Digital LCD

TRANSDUCER
Number Up to 2 Up to 2 (1) Up to 2 Up to 2
ERA, cm2 1.6, 6 1.6, 6 1.6, 6 1.6, 6
Multifrequency
capability No No No No
Plug-in/hardwired Plug-in (3) Plug-in (3) Plug-in (3) Plug-in (3)
NEUROMUSCULAR
STIMULATOR Yes Yes No Yes

POWER SOURCE, VAC 110/220 110/220 110/220 110/220


Hz 50/60 or battery 50/60 50/60 50/60
H x W x D, cm (in) 9 x 25 x 28 10 x 36 x 29.5 15 x 44 x 14.2 15 x 44 x 14.2
(3.5 x 9.8 x 10.9) (3.9 x 14 x 11.5) (5.9 x 17.3 x 5.6) (5.9 x 17.3 x 5.6)
WEIGHT, kg (lb) 9 (19.8) 9 (19.8) 10 (22) 10 (22)
LIST PRICE $2,170-2,425 $2,000-2,385 $2,500-2,950 $2,800-3,200

WARRANTY Not specified Not specified Not specified Not specified

DELIVERY TIME, ARO 1 month 1 month 1 month 1 month


YEAR FIRST SOLD 1993 1996 2000 2000
FISCAL YEAR Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Alternative battery Ultrasound feedback Ultrasound feedback Ultrasound feedback
operation; ultra- contact control; contact control; contact control;
sound feedback con- microprocessor self- microprocessor self- microprocessor self-
tact control; micro- calibration test; calibration test; calibration test;
processor self-cali- watertight sound watertight sound watertight sound
bration head; para- head; parameters can head; parameters can head; parameters can
meters can be modi- be modified during be modified during be modified during
fied during treat- treatment; prepro- treatment; prepro- treatment; prepro-
ment. ISO 9001 and grammed protocols; grammed protocols; grammed protocols;
46001. SCAM MODE. * SCAM MODE. SCAM MODE. *

Colons separate data on similar models of a device.


* ISO 9001 and 46001.

18 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL ELMED ELMED ELMED ELMED

210C 210C/HVG 500 210C/Stimulator 210S/Stimulator


Model 6195 Model 6210 Models 6100 : 6150 Model 6110
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) No No No No
CONFIGURATION Tabletop Tabletop Portable Tabletop

OUTPUT
Frequency, MHz 1 1 1 1
Maximum output, W 18 18 18 18

Maximum intensity,
W/cm2 3 3 3 3

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 50 50 50 50

Pulse rate, pps 120 120 120 120


BNR 8.5 8.5 8.5 8.5

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Analog Analog Analog Analog

TRANSDUCER
Number 1 1 1 1
ERA, cm2 6 6 6 6
Multifrequency
capability Not specified Not specified Not specified Not specified
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes Yes Yes Yes

POWER SOURCE, VAC 117 * 117 * 117 * 117 *


Hz 60 60 60 60
H x W x D, cm (in) 30.5 x 27.9 x 15.2 51 x 33 x 16 Not specified 30.5 x 27.9 x 15.2
(12 x 11 x 6) (20 x 13 x 6.3) (12 x 11 x 6)
WEIGHT, kg (lb) 7 (16) 9.9 (22) Various 7 (16)
LIST PRICE $1,495 $2,495 $2,145 : $1,695 $1,895

WARRANTY 1 year 1 year 1 year 1 year

DELIVERY TIME, ARO Stock Stock Stock Stock


YEAR FIRST SOLD Not specified Not specified Not specified Not specified
FISCAL YEAR January to December January to December January to December January to December
OTHER SPECIFICATIONS Can be combined with Combined with high- Unit combined with Unit combined with
separate stimulator voltage stimulator low-voltage faradic low-voltage faradic
unit on cart; auto- in modular cabinet stimulator in stimulator; has
matic transducer with mobile cart. modular cabinet; automatic shutoff
shutoff. mobile cart switch in the trans-
available. ducer cradle.

Colons separate data on similar models of a device.


* Others available.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 19
Healthcare Product Comparison System

Product Comparison Chart


MODEL ELMED ELMED ENRAF-NONIUS ENRAF-NONIUS
FAILED TO RESPOND * FAILED TO RESPOND *
Sonodynator 834 Sonostat 733 Sonopuls 190 Sonopuls 490 :
Model 6300 Model 6350 Sonopuls 491
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Tabletop Tabletop Tabletop, portable, Tabletop, portable,
cart cart
OUTPUT
Frequency, MHz 0.875 0.875 1 1, 3
Maximum output, W 10 12 15 15

Maximum intensity,
W/cm2 2.5 3 2 cont, 3 pulsed 1.5 cont, 3 pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 25 25 5-80 5-80 (continuous)

Pulse rate, pps 29 30 100 100


BNR 5.3 5.3 6, max 6, max

TIMER RANGE, min 0-20 0-25 0-30 0-30


OUTPUT POWER DISPLAY Digital Dial scale Digital Digital

TRANSDUCER
Number 1 1 1 2
ERA, cm2 4 1, 4 5 0.8, 5
Multifrequency
capability Not specified Not specified No Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Yes No Fixed No : Yes

POWER SOURCE, VAC 117 117 ** 110-120/220-240 110-120/220-240


Hz 48-62 60 50/60 50/60
H x W x D, cm (in) 49 x 15 x 41 40 x 9 x 27 22 x 20 x 19.5 29 x 28 x 10.5
(19.3 x 5.9 x 16.1) (15.7 x 3.5 x 10.6) (8.7 x 7.9 x 7.7) (11.4 x 11 x 4.1)
WEIGHT, kg (lb) 13 (29) 5 (11) 1.7 (3.7) 4 (8.8)
LIST PRICE $3,985 $2,495 Not specified Not specified

WARRANTY 1 year 1 year 2 years 2 years

DELIVERY TIME, ARO Stock Stock 2 weeks 2 weeks


YEAR FIRST SOLD Not specified Not specified 1999 1997
FISCAL YEAR January to December January to December January to December January to December
OTHER SPECIFICATIONS Combined with None specified. 10 programmable Battery; 10
diadynamic and low- positions. adjustable programs;
voltage stimulator. 1 central regulator;
contact control.

Colons separate data on similar models of a device.


* Specifications current as of April 2001.
** Others available.

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Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL ENRAF-NONIUS ENRAF-NONIUS ERBE ELEKTROMEDIZIN ERBE ELEKTROMEDIZIN
FAILED TO RESPOND * FAILED TO RESPOND *
Sonopuls 590 : Sonopuls 992+ Erbogalvan E2 Erbosonat Comfort
Sonopuls 591 VAK Plus
WHERE MARKETED Worldwide Worldwide Worldwide, except Worldwide, except
USA USA

FDA CLEARANCE Yes No No No


CE MARK (MDD) Yes Yes CE 0124 CE 0124
CONFIGURATION Tabletop, portable, Tabletop, portable, Tabletop or with Tabletop
cart cart movable trolley
OUTPUT
Frequency, MHz 1, 3 1, 3 1 1
Maximum output, W 15 15 7.5 cont unmodulated 15
15 pulse modulated
Maximum intensity,
W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 1.5 pulse modulated, 1.5 continuous, 3
3 continuous pulsed
Continuous beam Yes Yes Yes Yes
Pulsed beam Yes Yes Yes Yes
Duty cycle, % 20 20 10, 20, 33 10, 20, 33

Pulse rate, pps 16, 48, 100 16, 48, 100 100 100
BNR 6, max 6 max Not specified Not specified

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 4 2 2 2
ERA, cm2 0.5, 0.8, 5 0.8, 5 2.5, 5 2.5, 5
Multifrequency
capability No Yes Not specified Not specified
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No : Yes Yes Yes In combination with
Erbogalvan Comfort
POWER SOURCE, VAC 110-120/220-240 110-120/220-240 120-240 ±10% 120/240 ±10%
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 12 x 36 x 33.5 13.5 x 36 x 38 9.2 x 31.5 x 33.2 10 x 40 x 37
(4.7 x 14.2 x 13.2) (5.3 x 14.2 x 15) (3.6 x 12.3 x 13) (3.9 x 15.7 x 14.6)
WEIGHT, kg (lb) 6.1 (13.4) 8.5 (18.7) 3.9 (8.6) 6.7 (14.8)
LIST PRICE Not specified Not specified €3,818 (US$3,729) €2,648 (US$2,607)

WARRANTY 2 years 2 years 2 years 2 years

DELIVERY TIME, ARO 2 weeks 2 weeks Not specified Not specified


YEAR FIRST SOLD 1990 : 1991 1994 2000 1994
FISCAL YEAR January to December January to December January to December January to December
OTHER SPECIFICATIONS Suitable for 2 separated chan- Meets requirements Meets requirements
combination therapy; nels; protocols for of EU Directive 93/ of IEC 601-1 and VDE
contact control : treatment; memory 42 EEC IIb, ERBE 0750.
20 adjustable cards; computer quality assurance,
programs; contact connection; contact ISO 9001/EN 6001,
control. control; extra- and protective class
large display. EN 60601-1.

Colons separate data on similar models of a device.


* Specifications current as of April 2001.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 21
Healthcare Product Comparison System

Product Comparison Chart


MODEL HERO MEDICAL HERO MEDICAL HERO MEDICAL INNOKAS MEDICAL
FAILED TO RESPOND *
DM1 : DM2 DM 3 DP 1 PTC 2100 Ultrasound

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide, except


USA

FDA CLEARANCE No No No Not specified


CE MARK (MDD) Not specified Not specified Not specified Yes
CONFIGURATION Tabletop Tabletop Portable Tabletop

OUTPUT
Frequency, MHz 1 1 and 3 1 1, 3
Maximum output, W 15 15 2.5 15

Maximum intensity,
W/cm2 3 3 1 2 cont, 3 pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 1-100 : 50 1-100 50 11, 14, 20, 33, 50

Pulse rate, pps 1-100 : 100 1-100 100 100


BNR Not specified Not specified Not specified <7

TIMER RANGE, min 0-15 0-15 0-5 0-30


OUTPUT POWER DISPLAY Digital Digital LED Digital

TRANSDUCER
Number 1 2 1 2
ERA, cm2 5 5 2.5 2.1, 4.7
Multifrequency
capability No Yes No No
Plug-in/hardwired Hardwired Plug-in Hardwired Plug-in
NEUROMUSCULAR
STIMULATOR No No No Combination
available
POWER SOURCE, VAC 110/240 110/240 110/240 110/240
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 45 x 32 x 11 45 x 32 x 11 8x4x3 8.5 x 33 x 33
(17.8 x 12.6 x 4.3) (17.8 x 12.6 x 4.3) (3.2 x 1.6 x 1.2) (3.3 x 13 x 13)
WEIGHT, kg (lb) 2.2 (4.8) 2.5 (5.5) 0.2 (0.44) 6.5 (14.3)
LIST PRICE AU$850 (US$474) : AU$1,100 (US$615) AU$195 (US$109) Not specified
AU$760 (US$525)
WARRANTY 1 year 1 year 1 year 2 years

DELIVERY TIME, ARO 1 week 1 week 1 week 4 weeks


YEAR FIRST SOLD 1990 1991 1990 1994
FISCAL YEAR July to June July to June July to June January to December
OTHER SPECIFICATIONS Briefcase optional. Briefcase optional. Portable for Skin contact control
personal use. reduces power if
poor coupling
between sound head
and patient; sound
heads individually
calibrated by com-
puter; calibration
data stored inside
sound head.

Colons separate data on similar models of a device.


* Specifications current as of September 1999.

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Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL ITO ITO KLD BIOSISTEMAS KLD BIOSISTEMAS

US-100 US-700 Avatar 1-1MHz Avatar 1-Esthetic


TUS0101 TUS0102
WHERE MARKETED Worldwide Worldwide Brazil Brazil

FDA CLEARANCE Submitted Submitted No No


CE MARK (MDD) Yes Yes No No
CONFIGURATION Portable Tabletop Portable Portable

OUTPUT
Frequency, MHz 0.8 1, 3 1 2.5
Maximum output, W 12 16.2 15 15

Maximum intensity,
W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 3 3

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes yes Yes
Duty cycle, % 2.9 ±30 5, 10, 20, 30, 50 20 20

Pulse rate, pps 100 100 100 100


BNR <4 <4 <8 <8

TIMER RANGE, min 0-30 0-30 3-18 3-18


OUTPUT POWER DISPLAY LCD LCD LED LED

TRANSDUCER
Number 2 2 1 1
ERA, cm2 0.8, 4 0.9, 5.5 3 3
Multifrequency
capability No Yes No No
Plug-in/hardwired AC adapter Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No Optional No No

POWER SOURCE, VAC 110-240 110-240 120/220 120/220


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 22.7 x 20.7 x 9.3 120 x 33 x 25 7 x 12 x 20 7 x 12 x 20
(8.9 x 8.1 x 3.7) (47.2 x 13 x 9.8) (2.8 x 4.8 x 8) (2.8 x 4.8 x 8)
WEIGHT, kg (lb) 2 (4.4) 6 (13.2) 1 (2.2) 1 (2.2)
LIST PRICE $1,200 $1,990 $330 $340

WARRANTY 1 year 1 year 1 year 1 year

DELIVERY TIME, ARO 40 days 40 days Stock Stock


YEAR FIRST SOLD 2001 1997 2000 2000
FISCAL YEAR January to December January to December January to December January to December
OTHER SPECIFICATIONS AC/DC dual power Programmable; 36 Watertight sound Watertight sound
source; 10 preset memories; treatment head. head; product mar-
programs; 1 free protocols; automatic keted for cellulitis
user-programmable contact control; and lymphodrainage.
memory; auto automatic
contact control; calibration.
adjustable coupling CE mark.
sensitivity; LCD
screen; automatic
calibration.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 23
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Product Comparison Chart


MODEL KLD BIOSISTEMAS KLD BIOSISTEMAS KLD BIOSISTEMAS KLD BIOSISTEMAS

Avatar 2-1MHz Avatar 2-Esthetic Avatar 3 Avatar 5


TUS0201 TUS0202 TUS0203 US9705
WHERE MARKETED Brazil Brazil Brazil Brazil

FDA CLEARANCE No No No No
CE MARK (MDD) No No No No
CONFIGURATION Portable, tabletop Portable, tabletop Tabletop Tabletop/cart

OUTPUT
Frequency, MHz 1 2.5 1, 2.5 1, 3
Maximum output, W 15 15 15 15

Maximum intensity,
W/cm2 3 3 3 3

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 5, 10, 20 5, 10, 20 5, 10, 20 5, 10, 20

Pulse rate, pps 96 96 96 16, 48, 100


BNR <8 <8 <8 <6.5

TIMER RANGE, min 1-30 1-30 1-30 1-30


OUTPUT POWER DISPLAY Digital LCD Digital LCD Digital LCD Digital LCD

TRANSDUCER
Number 1 1 2 6
ERA, cm2 3 3 3 1, 3, 5
Multifrequency
capability No No No No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No No Connector for Connector for
external stimulator external stimulator
POWER SOURCE, VAC 120/220 120/220 120-220 120-220
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 12 x 29 x 32 12 x 29 x 32 12 x 29 x 32 12 x 40 x 32
(4.8 x 11.5 x 12.6) (4.8 x 11.5 x 12.6) (4.8 x 11.5 x 12.6) (4.8 x 15.6 x 12.6)
WEIGHT, kg (lb) 3 (6.6) 3 (6.6) 3.4 (7.5) 4.7 (10.36)
LIST PRICE $550 $560 $730 $1,470

WARRANTY 1 year 1 year 1 year 1 year

DELIVERY TIME, ARO 1 week 1 week 1 week 2 weeks


YEAR FIRST SOLD 2002 2002 2002 1998
FISCAL YEAR January to December January to December January to December January to December
OTHER SPECIFICATIONS Watertight sound Watertight sound Watertight sound Watertight sound
head; auto contact head; product mar- heads; product mar- heads; constant
control; 8 program- keted for cellulitis keted for cellulitis power output; auto-
mable positions. and lymphodrainage; and lymphodrainage; corrected according
Meets requirements auto contact con- auto contact con- to tissue thickness;
of IEC 60601. trol; 8 programmable trol; 8 programmable auto contact con-
positions. Meets re- positions; suitable trol; 48 program-
quirements of IEC for combination mable positions;
60601. therapy. * suitable for combi-
nation therapy. *

Colons separate data on similar models of a device.


* Meets requirements of IEC 60601.

24 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL KLD BIOSISTEMAS KLD BIOSISTEMAS KW INDUSTRIA KW INDUSTRIA

US 9002 US 9005 Liposonomaster Sonomaster


Dual Microcontrolado
WHERE MARKETED Brazil Brazil Brazil Brazil

FDA CLEARANCE Not specified Not specified Not specified No


CE MARK (MDD) Not specified Not specified Not specified No
CONFIGURATION Tabletop/cart Tabletop/cart Tabletop Tabletop

OUTPUT
Frequency, MHz 1 1, 3 3 1, 3
Maximum output, W 12 12 8 10

Maximum intensity,
W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 2 cont 2.5

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 5, 10, 20 5, 10, 20 20 10, 20, 50

Pulse rate, pps 128 128 100 16, 100


BNR Not specified Not specified Not specified Not specified

TIMER RANGE, min 0-9 0-15 6-36 1-30


OUTPUT POWER DISPLAY Digital Digital Analog LCD

TRANSDUCER
Number 1 2 2 2
ERA, cm2 4 4 4 4
Multifrequency
capability Not specified Not specified No Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No Optional No No

POWER SOURCE, VAC 117/220 117/220 120/220 110/220


Hz 60 60 50/60 50/60
H x W x D, cm (in) 9 x 19 x 22 9 x 46 x 22 9 x 20 x 35 9 x 20 x 35
(3.5 x 7.5 x 8.7) (3.5 x 18.1 x 8.7) (3.5 x 7.9 x 13.8) (3.5 x 7.9 x 13.8)
WEIGHT, kg (lb) 4.5 (10) 7 (16) 4 (8.8) 4 (8.8)
LIST PRICE $780 $1,217 $712 $1,487

WARRANTY 1 year 1 year 18 months 18 months

DELIVERY TIME, ARO Not specified Not specified Immediate Immediate


YEAR FIRST SOLD Not specified Not specified 1993 1999
FISCAL YEAR Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS None specified. Ultrasound feedback None specified. 2-channel output.
contact control.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 25
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Product Comparison Chart


MODEL KW INDUSTRIA KW INDUSTRIA KW INDUSTRIA LASER INSTRUMENTS

Sonomaster Sonomaster Standard Sonomaster Standard CTL-1107


Microcontrolado 1 MHz : 3 MHz
WHERE MARKETED Brazil Brazil Brazil Worldwide

FDA CLEARANCE No Not specified No No


CE MARK (MDD) No Not specified No Yes
CONFIGURATION Tabletop Tabletop Tabletop Tabletop, cart

OUTPUT
Frequency, MHz 1, 3 1 1:3 1, 3
Maximum output, W 10 12 10 : 12 15

Maximum intensity,
W/cm2 2.5 3 cont 3 2 cont, 3 pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50 20 20 12.5, 25, 50

Pulse rate, pps 16, 100 100 100 46, 48 or 100


BNR Not specified Not specified Not specified 6.1

TIMER RANGE, min 1-30 Not specified 1-15 0-60


OUTPUT POWER DISPLAY LCD Analog 7-segment display Not specified

TRANSDUCER
Number 1 1 1 2
ERA, cm2 4 4 4 5, 10
Multifrequency
capability Yes No No Not specified
Plug-in/hardwired Plug-in Plug-in Plug-in Not specified
NEUROMUSCULAR
STIMULATOR No No No Yes

POWER SOURCE, VAC 110/220 120/220 110/220 120/240


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 9 x 20 x 25 7 x 14 x 19.5 7 x 14 x 19.5 10.5 x 37.5 x 28.5
(3.5 x 7.9 x 9.8) (2.8 x 5.5 x 7.7) (2.8 x 5.5 x 7.7) (4.1 x 14.8 x 11.2)
WEIGHT, kg (lb) 3.8 (8.4) 1.9 (4.2) 1.9 (4.2) 5 (11)
LIST PRICE $850 $322 $400 Not specified

WARRANTY 18 months 18 months 18 months 1 year

DELIVERY TIME, ARO Immediate Immediate Immediate 2 weeks


YEAR FIRST SOLD 1998 1990 1999 1991
FISCAL YEAR Not specified Not specified Not specified October to September
OTHER SPECIFICATIONS NBR IEC 60601 None specified. None specified. Built-in clinical
certified. protocols; trans-
ducer designed to be
waterproof; can be
combined with
separate stimulator
unit.

Colons separate data on similar models of a device.

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Product Comparison Chart


MODEL METRAX METRON METRON METRON

PRIMEDIC Sono I Accusonic Accusonic Plus Sonic

WHERE MARKETED Not specified Worldwide Worldwide Worldwide

FDA CLEARANCE No Yes Yes Yes


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Tabletop, cart Tabletop, portable Tabletop, portable Tabletop, portable

OUTPUT
Frequency, MHz 1 1 1, 3 1
Maximum output, W 15 15 15 15

Maximum intensity,
W/cm2 1, 3 3 3 3

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10-100 10, 20, 50 10, 20, 50 50

Pulse rate, pps 50, 100 50 50 50/60


BNR Not specified 6 6 6

TIMER RANGE, min 0-30 0-20 0-20 0-9


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 2 1 2 1
ERA, cm2 2, 5 5 0.75, 5 5
Multifrequency
capability No No Yes No
Plug-in/hardwired Plug-in Hardwired Plug-in Hardwired
NEUROMUSCULAR
STIMULATOR No Optional Optional Optional

POWER SOURCE, VAC 110/120/220/240 110/220/240 110/220/240 110/220/240


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 34 x 42 x 15 17 x 12 x 28 17 x 12 x 28 17 x 12 x 20
(13.4 x 16.5 x 5.9) (6.7 x 4.7 x 11) (6.7 x 4.7 x 11) (6.7 x 4.7 x 7.9)
WEIGHT, kg (lb) 6 (13.2) 2.5 (5.5) 2.5 (5.5) 2.5 (5.5)
LIST PRICE DM 3,130 (US$1,487) $550 $675 $500

WARRANTY 1 year 2 years 2 years 2 years

DELIVERY TIME, ARO 2 weeks Stock Stock Stock


YEAR FIRST SOLD 1990 2000 1999 1999
FISCAL YEAR Not specified July to June July to June July to June
OTHER SPECIFICATIONS None specified. Optional carry case. Optional carry case. Optional carry case.
ISO 9001 certified ISO 9001 certified ISO 9001 certified
manufacturer. manufacturer. manufacturer.

Colons separate data on similar models of a device.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 27
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Product Comparison Chart


MODEL METTLER ELECTRONICS METTLER ELECTRONICS METTLER ELECTRONICS METTLER ELECTRONICS

Sonicator 715 : 716 Sonicator 730 Sonicator Plus 930 Sonicator Plus 992 :
Sonicator Plus 994
WHERE MARKETED Worldwide Worldwide Not specified Worldwide

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Portable/wall mount Portable/wall mount Tabletop, cart Tabletop, cart

OUTPUT
Frequency, MHz 1 1, 3.3 1, 3.2, 3.3 1, 3.2, 3.3
Maximum output, W 11 : 22 2.2, 11, 22 2.2, 11, 22 2.2, 11, 22

Maximum intensity,
W/cm2 2.2 2.2 2.2 2.2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 20 20 20 20, 50

Pulse rate, pps 100 100 100 100


BNR 6:1 or less 6:1 or less 6:1 or less 6:1 or less

TIMER RANGE, min 1-29 1-29 1-30 1-30


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 1 4 3 3
ERA, cm2 5 : 10 1, 5, 10 * 1, 5, 10 * 1, 5, 10 *
Multifrequency
capability No Yes Yes Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Optional Optional Yes Yes

POWER SOURCE, VAC 115/230 115/230 90-240 90-240


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 10.2 x 15 x 27.9 10.2 x 15 x 27.9 15.2 x 30.5 x 30.5 12.7 x 36.8 x 25.4
(4 x 6 x 11) (4 x 6 x 11) (6 x 12 x 12) (5 x 14.5 x 10)
WEIGHT, kg (lb) 2.3 (5) 2.3 (5) 4 (8.7) 4.9 (10.8)
LIST PRICE $1,340 $1,665 $2,895 $3,295 : $3,895

WARRANTY 2 years 2 years 2 years 2 years

DELIVERY TIME, ARO Stock Stock Stock Stock


YEAR FIRST SOLD 1994 1995 2002 1999
FISCAL YEAR March to February March to February March to February March to February
OTHER SPECIFICATIONS Auto shutoff if poor Auto shutoff if poor 2 channels of (2 : 4) channels of
coupling between coupling between stimulation with stimulation with
patient & applicator patient & applicator ultrasound; up to ultrasound; up to
detected; LED poor- detected; LED poor- 3 treatment proto- (3 : 5) treatment
coupling indicator; coupling indicator; cols may be run at protocols may run at
cart and tote bag universal applicator same time. Meets re- same time. Conforms
available. Meets cable. Meets re- quirements of CETL, to CETL, CSA C22.2
requirements of quirements of CSA C22.2 601-1-M90, No. 601-1-M90, EN-
CISPR II, CUL, FCC, CISPR II, CUL, FCC, EN-55011, ETL, and 55011, ETL, and
IEC, and UL. IEC, and UL. FCC Part 15. FCC Part 15-B. **

Colons separate data on similar models of a device.


* 1 cm2 @ 3.3 MHz; 5 cm2 @ 1 or 3.3 MHz; 10 cm2 @ 1 MHz.
** Also meets requirements of IEC 60601-2-10 and UL 2601-1-UL.

28 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL NEMECTRON NEMECTRON NEMECTRON PHYSIOMED

Nemectroson Nemectroson Nemectroson IONOSON


110 210 400
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Not specified Not specified Not specified No


CE MARK (MDD) Not specified Not specified Not specified Yes
CONFIGURATION Tabletop, cart Tabletop, cart Tabletop, cart Tabletop, portable,
cart
OUTPUT
Frequency, MHz 1, 3 1, 3 1, 3; 1-3 stochastic 1
Maximum output, W 10.8 10.8 5.4, 10.8 15

Maximum intensity,
W/cm2 3 3 1.5, 3 2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 5, 10, 20, 50 5, 10, 20, 50 5, 10, 20, 50 10, 33, 40, 50

Pulse rate, pps 100 100 100 Not specified


BNR 4.5 (1 MHz); 4.5 (1 MHz); 4.5 (1 MHz); 3 (3 Not specified
3 (3 MHz) 3 (3 MHz) MHz); 3 (1-3 MHz)
TIMER RANGE, min 0-30 0-30 0-30 0-30
OUTPUT POWER DISPLAY Digital LCD Digital LCD Digital LCD Digital

TRANSDUCER
Number 2 2 4 2
ERA, cm2 3.6, 4 3.6, 4 3.6, 4 2.5, 5
Multifrequency
capability Yes Yes Yes No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Optional Optional Optional Yes

POWER SOURCE, VAC 100-240 100-240 100-240 115/230 ±10%


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 10 x 40 x 25 16 x 50 x 32 9.5 x 45 x 45 80 x 37.5 x 25
(3.9 x 15.8 x 9.9) (6.3 x 19.7 x 12.6) (3.7 x 17.7 x 17.7) (31.5 x 14.8 x 9.8)
WEIGHT, kg (lb) 6 (13.2) 6.5 (14.3) 7.5 (16.5) 4.3 (9.5)
LIST PRICE Not specified Not specified Not specified Not specified

WARRANTY 1 year 1 year 1 year 1 year

DELIVERY TIME, ARO Not specified 4-6 weeks 4-6 weeks Stock
YEAR FIRST SOLD Not specified Not specified Not specified 1995
FISCAL YEAR January to December January to December January to December Not specified
OTHER SPECIFICATIONS Timer/output stops Timer/output stopped Timer/output stopped Combination unit:
when contact w/skin when contact w/skin when contact w/skin electrotherapy and
lost for >1 sec, lost for >1 sec, lost for >1 sec, ultrasound.
reactivated with reactivated with reactivated with
resumed contact; resumed contact; resumed contact;
self-calibration and self-calibration and self-calibration and
contact display. contact display. contact display.
Approved in accor- Approved in accor- Approved in accor-
dance wth IEC 601-1. dance wth IEC 601-1. dance wth IEC 601-1.

Colons separate data on similar models of a device.

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MODEL PHYSIOMED PHYSIOMED PHYSIOMED RICH-MAR

IONOSON-Expert PHYSION-Expert PHYSIOSON 03A AutoSound 3.5

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE No No No Yes


CE MARK (MDD) Yes Yes Yes No
CONFIGURATION Tabletop, cart Tabletop, cart Tabletop, portable Tabletop, cart,
portable
OUTPUT
Frequency, MHz 1, 3 1, 3 1 1, 3
Maximum output, W 15 15 2.5 8

Maximum intensity,
W/cm2 3 3 1 2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 33, 40, 50 10, 30, 40, 50 10, 33, 40, 50 10, 20, 50

Pulse rate, pps 100 100 100 40, 80, 200


BNR <6 <6 <6 5.5 : 1

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 2 2 1 4
ERA, cm2 2.5, 5 2.5, 5 2.5 4
Multifrequency
capability Yes Yes No Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Hardwired
NEUROMUSCULAR
STIMULATOR Yes No No No

POWER SOURCE, VAC 115/230 ±10% 115/230 ±10% 115/230 ±10% 115/230
Hz 50/60 50/60 50 50/60
H x W x D, cm (in) 34.5 x 13.3 x 34.8 12 x 37 x 27 8.5 x 27 x 25 12 x 9 x 7
(13.6 x 5.2 x 13.7) (4.7 x 14.6 x 10.6) (3.3 x 10.6 x 9.8) (4.7 x 3.5 x 2.8)
WEIGHT, kg (lb) 5.5 (12.1) 3.9 (8.6) 2.5 (5.5) 8 (17.6)
LIST PRICE Not specified Not specified Not specified $3,399

WARRANTY 1 year 1 year 1 year 2 years; 5 years


optional
DELIVERY TIME, ARO Stock Stock Stock Not specified
YEAR FIRST SOLD 2000 1999 1995 1999
FISCAL YEAR Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Combination unit: Indication index; Battery operated. UL listed.
electrotherapy and memory function.
ultrasound; treat-
ment proposals.

Colons separate data on similar models of a device.

30 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL RICH-MAR RICH-MAR RICH-MAR RICH-MAR

AutoSound 5.6 AutoSound 5.8 Model 25 Multi-Hz Model V : Model X

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Submitted Submitted Yes Yes


CE MARK (MDD) No No No No
CONFIGURATION Tabletop, cart, wall Tabletop, cart, Tabletop, cart, wall Tabletop, cart or
hanging, portable portable mount wall mount
OUTPUT
Frequency, MHz 1, 3 1, 3 1, 3 1
Maximum output, W 8 8 4, 10 10 : 20

Maximum intensity,
W/cm2 2 2l 2 2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 30 10, 20, 30 10, 15, 20, 25, 10, 15, 20, 25,
30, 35 30, 35
Pulse rate, pps 40, 80, 200 40, 80, 200 40-140 40-140
BNR 5.5 : 1 5.5 : 1 5.5 5.5

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Digital Digital Analog Analog

TRANSDUCER
Number 4* 4 2 1
ERA, cm2 3.5 4 2, 5 5 : 10
Multifrequency
capability Yes Yes Yes No
Plug-in/hardwired Hardwired Hardwired Hardwired Hardwired
NEUROMUSCULAR
STIMULATOR No No No No

POWER SOURCE, VAC 115/230 115/230 120 120


Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 12 x 9 x 7 12 x 9 x 7 48.3 x 23.2 x 12.7 11.4 x 23.2 x 36.8
(4.7 x 3.5 x 2.8) (4.7 x 3.5 x 2.8) (19 x 9.1 x 5) (4.5 x 9.1 x 14.5)
WEIGHT, kg (lb) 8 (17.6) 8 (17.6) 6.8 (15) 5.4 (12)
LIST PRICE $3,499 $3,399 $1,849 $1,395 : $1,475

WARRANTY 2 years; 3 years 2 years; 3 years 3 years; additional 3 years; additional


optional optional 2 years optional 2 years optional
DELIVERY TIME, ARO Not specified Not specified Not specified Not specified
YEAR FIRST SOLD 2002 2002 1992 1991
FISCAL YEAR Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Patent pending on Patent pending on Watertight Watertight sound
hands-free ultra- hands-free ultra- sound heads. CSA head; portable
sound; mimics human sound; mimics human certified. carrying case avail-
application by mov- application by mov- able. CSA certified.
ing the ultrasound ing the ultrasound
field via micropro- field via micropro-
cessor control over cessor control over
multiple crystals; multiple crystals;
applicator secured applicator secured
with straps. with straps.

Colons separate data on similar models of a device.


* 1 hands-free applicator.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 31
Healthcare Product Comparison System

Product Comparison Chart


MODEL RICH-MAR RICH-MAR RICH-MAR SKYLARK

Therasound 3.1/3.2 Therasound 3.4 Therasound 3.5 SD-956 Ultrasonic


Therapeutic Unit
WHERE MARKETED Worldwide Worldwide Worldwide Europe, Far East,
USA

FDA CLEARANCE Yes Yes Yes Yes


CE MARK (MDD) No No No Yes
CONFIGURATION Tabletop, cart, Tabletop, cart, Tabletop, cart, Tabletop
portable portable portable
OUTPUT
Frequency, MHz 1 1, 3 1, 3 1, 3
Maximum output, W 10, 20 10 4, 10 2, 7.6

Maximum intensity,
W/cm2 2 2 2 2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50 10, 20, 50 10, 20, 50 10, 50

Pulse rate, pps 40, 80, 200 40, 80, 200 40, 80, 200 100
BNR 5.5:1 5.5:1 5.5:1 5.5

TIMER RANGE, min 0-30 0-30 0-30 0-30


OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCER
Number 1 1 1 with 2 sound heads 2
ERA, cm2 5, 10 5 2, 5 1, 4.4
Multifrequency
capability No Yes Yes No
Plug-in/hardwired Hardwired Hardwired Hardwired Plug-in
NEUROMUSCULAR
STIMULATOR No No No No

POWER SOURCE, VAC 115/230 115/230 115/230 110, 220


Hz 50/60 50/60 50/60 60, 50
H x W x D, cm (in) 10.2 x 19 x 19 10.2 x 19 x 19 10.2 x 19 x 19 12 x 30.5 x 25.5
(4 x 7.5 x 7.5) (4 x 7.5 x 7.5) (4 x 7.5 x 7.5) (3.9 x 12 x 10)
WEIGHT, kg (lb) 2.5 (5.5) 2.5 (5.5) 2.5 (5.5) 5.5 (12.1)
LIST PRICE $1,299 $1,599 $1,899 Not specified

WARRANTY 2 years; 5 years 2 years; 5 years 2 years; 5 years 1 year


optional optional optional
DELIVERY TIME, ARO Not specified Not specified Not specified 45 days
YEAR FIRST SOLD 1999 1999 1999 2000
FISCAL YEAR Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Portable versions Portable versions 2 sound heads on 1 Meets requirements
available. UL available. UL transducer; of CE 0434 and ISO
certified. certified. portable versions 9001/1994. NS-EN
available. UL 4-6001 revision
certified. certified.

Colons separate data on similar models of a device.

32 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL SKYLARK SKYLARK TRUMPF TRUMPF
FAILED TO RESPOND * FAILED TO RESPOND *
SD-957 Ultrasonic SD-958 Ultrasonic DR BORN Impulsaphon Sonosan 50
Therapeutic Unit Therapeutic Unit NT 50
WHERE MARKETED Europe, Far East, Europe, Far East, Worldwide, except Worldwide, except
USA USA USA USA

FDA CLEARANCE Yes Yes Not specified Not specified


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Portable Portable Tabletop Portable

OUTPUT
Frequency, MHz 1 3 1 1
Maximum output, W 1.8 1.2 15 15

Maximum intensity,
W/cm2 0.45 0.3 3 3

Continuous beam No No Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10 15 5, 10, 20, 100 10, 20, 100

Pulse rate, pps 100 100 100 100


BNR 5.5 5.5 Not specified Not specified

TIMER RANGE, min 10 (auto off) 15 (auto off) 0-15 0-15


OUTPUT POWER DISPLAY Not specified Not specified Digital Potentiometer scale

TRANSDUCER
Number 1 1 2 2
ERA, cm2 4 4 2.5, 5 2.5, 5
Multifrequency
capability No No No No
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No No Connector for Connector for
external stimulator external stimulator
POWER SOURCE, VAC 110, 220 110, 220 115/230 115/230
Hz 60, 50 60, 50 50/60 50/60
H x W x D, cm (in) 5 x 4.5 x 19 5 x 4.5 x 19 7 x 36.5 x 27 10.5 x 27 x 22
(2 x 1.8 x 7.5) (2 x 1.8 x 7.5) (2.8 x 14.4 x 10.6) (4.1 x 10.6 x 8.7)
WEIGHT, kg (lb) 0.2 (0.44) 0.2 (0.44) 4 (8.8) 4 (8.8)
LIST PRICE Not specified Not specified See footnote ** See footnote ***

WARRANTY 1 year 1 year 18 months 18 months

DELIVERY TIME, ARO 45 days 45 days Stock Stock


YEAR FIRST SOLD 2001 2001 1996 1996
FISCAL YEAR Not specified Not specified July to June July to June
OTHER SPECIFICATIONS Meets requirements Meets requirements Certificate of Certificate of
of CE 0434, and ISO of CE 0434, and ISO quality assurance. quality assurance.
9001/1994. NS-EN 9001/1994. NS-EN
4-4001 revision 4-6001 revision
certified. certified.

Colons separate data on similar models of a device.


* Specifications current as of April 2001.
** DM 2,190 (US$1,040) for unit without transducer; DM 650 (US$309) for transducer (2.5 or 5 cm2 ERA treatment head).
*** DM 2,160 (US$1,026) for unit without transducer; DM 650 (US$309) for transducer (2.5 or 5 cm2 ERA treatment head).

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 33
Healthcare Product Comparison System

Product Comparison Chart


MODEL TRUMPF TUR TUR TUR
FAILED TO RESPOND *
Sonosan 100 Curatur 421 current- Sonotur 410 Sonotur 420
ultrasonic combo
WHERE MARKETED Worldwide, except Worldwide Worldwide Worldwide
USA

FDA CLEARANCE Not specified Not specified Not specified Not specified
CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Portable Tabletop, cart Handheld Tabletop, cart

OUTPUT
Frequency, MHz 1, 3 1 0.8 1
Maximum output, W 13.5 @ 1 MHz, 6 cont 1.4 8 cont
6 @ 3 MHz
Maximum intensity,
W/cm2 2.7 @ 1 MHz, 1.5 cont, 3 pulsed 1 cont 2 cont, 3 pulsed
1.2 @ 3 MHz
Continuous beam Yes Yes Yes Yes
Pulsed beam Yes Yes No Yes
Duty cycle, % 5, 10, 20, 100 10, 30 NA 10, 20, 30, 50

Pulse rate, pps 100 50 NA 50


BNR Not specified 6:1 or less 6:1 or less 6:1 or less

TIMER RANGE, min 0-30 0-30 0-9 0-30


OUTPUT POWER DISPLAY Digital See footnote ** LED luminous band See footnote **

TRANSDUCER
Number 2 2 1 2
ERA, cm2 2.5, 5 4; 1 optional 1 4; 1 optional
Multifrequency
capability Yes No No No
Plug-in/hardwired Plug-in Plug-in Hardwired Plug-in
NEUROMUSCULAR
STIMULATOR Connector for Built-in, low- No Optional with inter-
external stimulator frequency connection
POWER SOURCE, VAC 115/230 230; 115 on request 230; 115 on request 230; 115 on request
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 11.7 x 27 x 22 13 x 33 x 31 4 x 25 x 2 13 x 33 x 31
(4.6 x 10.6 x 8.7) (5.1 x 13 x 12) (1.5 x 9.8 x 1) *** (5.1 x 13 x 12)
WEIGHT, kg (lb) 4.1 (9) 4.5 (9.9) 0.17 (0.37) 3 (7)

LIST PRICE See footnote €2,550 (US$2,510) €1,050 (US$1,034) €1,750 (US$738)

WARRANTY 18 months 2 years 2 years 2 years

DELIVERY TIME, ARO Stock 3-4 weeks 3-4 weeks 3-4 weeks
YEAR FIRST SOLD 1999 1997 1992 1995
FISCAL YEAR July to June October to September October to September October to September
OTHER SPECIFICATIONS Certificate of Watertight sound Automatic shutoff Watertight sound
quality assurance. heads; automatic after treatment; heads; automatic
shutoff (if poor automatic ultrasonic shutoff if poor
coupling detected); energy reduction if coupling detected;
coupling indications poor coupling detec- coupling indications
at sound head & LED ted; all functions at sound head and
luminous band; self- combined in banana- LED luminous band;
calibration by test shaped handle; 4 self-calibration by
modes. †† levels of intensity; test modes. †††
carrying case.

Colons separate data on similar models of a device.


* Specifications current as of April 2001.
** Digital for predicted values. LED luminous band for current values.
*** Banana shaped.

DM 3,290 (US$1,563) for unit without transducer; DM 690 (US$180) for transducer (2.5 or 5 cm2 ERA treatment head).
††
Simultaneous/sequential ultrasound and electrical stimulation.
†††
Can be combined with medium-frequency stimulators.

34 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL TUR UNIPHY UNIPHY UNIPHY

Sonotur 430 Guidance C Gymna Combi 500 Phyaction 190i

WHERE MARKETED Worldwide Worldwide, except Worldwide, except Worldwide, except


USA USA USA

FDA CLEARANCE Not specified No No No


CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Tabletop, cart Tabletop Tabletop Tabletop

OUTPUT
Frequency, MHz 1 1, 3 1, 3 1, 3
Maximum output, W 8 cont 12 12 12

Maximum intensity,
W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 2 cont, 3 pulsed 2 cont, 3 pulsed

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 10, 20, 50 10, 20 30, 40, 50 10, 20, 30, 40, 50 6, 12, 25, 50, 100

Pulse rate, pps 50 100 100 100


BNR 6:1 or less <5 (1 MHz), <5 (1 MHz), <5 (1 MHz),
<8 (3 MHz) <8 (3 MHz) <4 (3 MHz)
TIMER RANGE, min 0-30 Not specified Not specified 0-30
OUTPUT POWER DISPLAY See footnote * Digital VGA LCD Digital VGA LCD Digital LCD

TRANSDUCER
Number 2 2 2 2
ERA, cm2 4; 1 optional 4; 1 optional 4; 1 optional 4; 1 optional
Multifrequency
capability No Yes Yes Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Optional with inter- Biphasic TENS, Biphasic TENS, No
connection interferential interferential
POWER SOURCE, VAC 230, 115 100/110/220/230/240 100/110/220/230/240 100/110/220/230/240
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 9 x 23 x 21 43 x 31 x 16 45 x 12.5 x 32 15 x 38 x 22
(3.5 x 9.1 x 8.3) (16.9 x 12.2 x 6.3) (17.7 x 5 x 12.6) (5.9 x 15 x 8.7)
WEIGHT, kg (lb) 2.7 (6) 9 (19.8) 8 (17.6) 5 (11)
LIST PRICE €1,425 (US$1,403) €5,100 (US$5,021) €4,300 (US$4,234) SFr 3,000 (US$1,837)

WARRANTY 2 years 1 year 1 year 1 year

DELIVERY TIME, ARO 3-4 weeks Not specified Not specified Not specified
YEAR FIRST SOLD 1999 Not specified Not specified Not specified
FISCAL YEAR October to September Not specified Not specified Not specified
OTHER SPECIFICATIONS Watertight sound 2 total independent 2 total independent Visual and acoustic
heads; automatic channels; coupling channels; coupling coupling control;
shutoff if poor control on display control on display memory of 20
coupling detected; and treatment heads; and treatment heads; treatments; can be
coupling indications memory of 500 memory of 500 combined with
at sound head; treatments; calcu- treatments; calcu- electrostimulation
self-calibration by lation of effective lation of effective unit; calculation of
test modes. output; indication output; indication effective output;
menu; GTS concept menu; GTS concept indication menu.
with help. with help. CE 0344 certified.

Colons separate data on similar models of a device.


* Digital for predicted values.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 35
Healthcare Product Comparison System

Product Comparison Chart


MODEL UNIPHY UNIPHY XLTEK XLTEK

Phyaction 793 Phyaction Supporta Ultra III/ Ultra IV


Ultra III-HV
WHERE MARKETED Worldwide, except Worldwide, except Worldwide Worldwide
USA USA

FDA CLEARANCE No No Not specified Not specified


CE MARK (MDD) Yes Yes Not specified Not specified
CONFIGURATION Tabletop Tabletop Cart Cart

OUTPUT
Frequency, MHz 1, 3 1, 3 1, 3 1, 3
Maximum output, W 12 8 15 15

Maximum intensity,
W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 2 2

Continuous beam Yes Yes Yes Yes


Pulsed beam Yes Yes Yes Yes
Duty cycle, % 1-100 12.5, 25, 50, 100 10-90 10-90

Pulse rate, pps 100 100 10-100 10-100


BNR <5 (1 MHz), <5 (1 MHz), 4 4
<4 (3 MHz) <4 (3 MHz)
TIMER RANGE, min 0-60 0-30 0-99 0-99
OUTPUT POWER DISPLAY Digital LCD Digital LCD Digital Digital

TRANSDUCER
Number 2 2 3 3
ERA, cm2 4; 1 optional 4; 1 optional 2, 5, 10 2, 5, 10
Multifrequency
capability Yes No Yes Yes
Plug-in/hardwired Plug-in Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR Biphasic TENS, Biphasic TENS, 2-channel 4-channel
interferential, NMES * interferential
POWER SOURCE, VAC 100/110/220/230/240 110-240; 12 V Ni-Cd 120/240 120/240
Hz 50/60 50/60 50/60 50/60
H x W x D, cm (in) 13 x 41 x 28 36 x 20 x 8 19 x 43 x 35.6 20 x 52 x 31.5
(5.1 x 16.1 x 11) (14.2 x 8 x 3.1) (7.5 x 17 x 14) (8 x 20.5 x 12.5)
WEIGHT, kg (lb) 6 (13.2) 2.5 (5.5) 11.3 (25) 9.5 (21)
LIST PRICE SFr 5,500 (US$3,368) SFr 3,100 (US$2,000) $3,495 $3,995

WARRANTY 1 year 1 year 1 year 1 year

DELIVERY TIME, ARO Not specified Not specified Immediate Immediate


YEAR FIRST SOLD Not specified Not specified 1994 1995
FISCAL YEAR Not specified Not specified February to January February to January
OTHER SPECIFICATIONS Coupling control on Coupling control on Total-energy- Total-energy-
display and treat- display; memory of delivered dose delivered dose
ment heads; memory 20 treatments; control. control.
of 250 treatments; indication menu;
calculation of CE 0344 certified.
effective output;
indication menu.
CE 0344 certified.

Colons separate data on similar models of a device.


* Continuous and interrupted current, Ultra Reiz, Diadynamic.

36 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Ultrasound Therapy Systems/Neuromuscular Stimulators

Product Comparison Chart


MODEL XLTEK ZIMMER ZIMMER

Ultra Max Sono 5 Sonostim

WHERE MARKETED Worldwide Worldwide Worldwide

FDA CLEARANCE Not specified Not specified Not specified


CE MARK (MDD) Not specified Yes Yes
CONFIGURATION Cart or wall mount Tabletop/cart Tabletop/portable

OUTPUT
Frequency, MHz 1, 3 0.8, 3 0.8, 3
Maximum output, W 15 1, 10 1, 10

Maximum intensity,
W/cm2 2 1, 3 1, 3

Continuous beam Yes Yes Yes


Pulsed beam Yes Yes Yes
Duty cycle, % 10, 20, 30, 50 20, 50 20, 50

Pulse rate, pps 100 20, 50 20, 50


BNR 4 <6 (3 MHz), <6 (3 MHz),
<5 (0.8 MHz) <5 (0.8 MHz)
TIMER RANGE, min 0-99 0-30 0-30
OUTPUT POWER DISPLAY Digital Digital Digital

TRANSDUCER
Number 3 2 2
ERA, cm2 2, 5, 10 1, 3.3 1, 3.3
Multifrequency
capability Yes No No
Plug-in/hardwired Plug-in Plug-in Plug-in
NEUROMUSCULAR
STIMULATOR No, I/P jack Combination possible Yes
installed
POWER SOURCE, VAC 120/240 120/230 120/230
Hz 50/60 50/60 50/60
H x W x D, cm (in) 14 x 29 x 31.5 14 x 45 x 32.5 14 x 21.5 x 36
(5.5 x 11.5 x 12.5) (5.5 x 17.7 x 12.8) (5.5 x 8.5 x 14.2)
WEIGHT, kg (lb) 8 (18) 6.8 (15) 4.8 (11)
LIST PRICE $1,495 €2,390 (US$2,342) €2,890 (US$2,831)

WARRANTY 1 year 2 years 2 years

DELIVERY TIME, ARO Immediate 2-3 weeks 2-3 weeks


YEAR FIRST SOLD 1993 1994 1995
FISCAL YEAR February to January Not specified Not specified
OTHER SPECIFICATIONS Total-energy- Treatment interrup- Treatment interrup-
delivered dose ted if insufficient ted if insufficient
control. coupling; micro- coupling; micro-
processor control; processor control;
self-diagnostics; self-diagnostics;
user-defined program user-defined program
memory; 40 preset memory; LCD; carry-
protocols; LCD; opt ing case; watertight
cart and watertight sound heads; 7
sound heads. * currents included. *

Colons separate data on similar models of a device.


* GS, SEV, and TUV (acc. VDE 0750/IEC 601-1) approved; manufacturer ISO 9001 certified.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 37

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