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November 2002 Ultrasound Therapy Systems, Physical Therapy; Ultrasound Therapy/Neuromuscular Stimulators, Physical Therapy 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 a neuromuscular stimulator to enhance pain-relief mechanisms and aid in the healing of soft-tissue injuries. The exact physiologic mechanisms of pain relief and accelerated tissue healing through local heating are unknown. Possibilities include increased local blood flow, increased local metabolic rate, muscle relaxation, and heightened pain threshold of nerves. Conditions involving scar-tissue tensions; ulcerations; bursitis; or muscle, tendon, ligament, or joint pain can be treated with ultrasonic energy. Similarly, the physiologic mechanisms of pain relief and enhanced tissue healing through nonthermal ef- fects of ultrasound are still under debate. Some theories 202594 424-008 Scope of this Product Comparison This Product Comparison covers tabletop, port- able, and cart- or wall-mounted therapeutic ul- trasound systems and combination ultrasound/ neuromuscular stimulator systems. Several low- frequency ultrasound physical therapy systems are also included in the chart. UMDNS information This Product Comparison covers the following device terms and product codes as listed in ECRI’s Universal Medical Device Nomenclature System™ (UMDNS™): Ultrasound Therapy Systems, Physical Therapy [11-248] Ultrasound Therapy/Neuromuscular Stimula- tion Systems, Physical Therapy [17-908] 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail [email protected] Portable ultrasound unit
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Page 1: ultrasonido terapeutico

November 2002

Ultrasound Therapy Systems, Physical Therapy;Ultrasound Therapy/NeuromuscularStimulators, Physical Therapy

PurposeTherapeutic ultrasound units convert electromag-

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

a neuromuscular stimulator to enhance pain-reliefmechanisms and aid in the healing of soft-tissue injuries.

The exact physiologic mechanisms of pain relief andaccelerated tissue healing through local heating areunknown. Possibilities include increased local bloodflow, increased local metabolic rate, muscle relaxation,and heightened pain threshold of nerves. Conditionsinvolving scar-tissue tensions; ulcerations; bursitis; ormuscle, tendon, ligament, or joint pain can be treatedwith ultrasonic energy.

Similarly, the physiologic mechanisms of pain reliefand enhanced tissue healing through nonthermal ef-fects of ultrasound are still under debate. Some theories

202594424-008

Scope of this Product ComparisonThis Product Comparison covers tabletop, port-able, and cart- or wall-mounted therapeutic ul-trasound systems and combination ultrasound/neuromuscular stimulator systems. Several low-frequency ultrasound physical therapy systemsare also included in the chart.

UMDNS informationThis Product Comparison covers the followingdevice terms and product codes as listed in ECRI’sUniversal Medical Device Nomenclature System™(UMDNS™):

• Ultrasound Therapy Systems, PhysicalTherapy [11-248]

• Ultrasound Therapy/Neuromuscular Stimula-tion Systems, Physical Therapy [17-908]

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USATelephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail [email protected]

Portable ultrasound unit

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propose that the increased release of analgesic chemi-cals or increased cell permeability to certain ions isresponsible. However, the most widely accepted expla-nation is acoustic streaming, which occurs in responseto mechanical pressure, in this case produced by theflow of ultrasonic energy. According to this theory, theenergy waves produced by the ultrasound transducercause extracellular fluids to move rapidly around thecell membrane, causing the cell to vibrate. The cellularvibrations produce gas-filled bubbles, a process knownas cavitation. For therapeutic purposes, the cavitationshould be stable: the bubbles should pulse but notexpand or burst. Stable cavitation leads to increasedcell permeability, which is believed to induce pain-re-lief mechanisms such as altered pain perceptions. Sta-ble cavitation is also believed to stimulate the releaseof collagen and increase platelet activity, which in turnspeeds the rate of healing. Transient cavitation isunstable and destructive to the cell and may result intissue damage. More research is needed to completelyunderstand the extent of nonthermal therapeutic ef-fects (Dyson 1987; Michlovitz 1996).

Principles of operationWhen tissues absorb energy, most of that energy is

converted into heat. Therapeutic ultrasound, a modal-ity used in the treatment of soft-tissue injuries, relieson a transducer to apply energy to the patient’s skinin the form of sound waves at frequencies well abovethose audible to the human ear. A frequency of 1 MHzis used for deep (3 to 5 cm) tissue, while a frequency of3 MHz is used for more superficial (1 to 2 cm) tissue.Ultrasonic energy is gradually absorbed and convertedto heat as it travels through the tissue; therefore, it ispossible to heat the underlying tissue without over-heating the skin itself. Muscle absorbs about twice asmuch ultrasonic energy as fat does; bone absorbs about10 times more than soft tissue does. In travelingthrough the first 3 cm of muscle, the ultrasonic beamretains about 50% of its surface intensity value, asatisfactory amount for deep heating. The rate atwhich tissue temperature increases when exposed tothe ultrasonic beam depends on the intensity (powerper unit area, expressed as watts/cm2) and local circu-lation, since blood will carry heat away from the area.

A therapeutic ultrasound unit has two basic compo-nents — a generator and a transducer. The electricaloutput of the generator is applied through a flexiblecable to a piezoelectric crystal in the transducer. Thecrystal converts electrical energy into acoustic energythrough the reverse piezoelectric effect: as the voltagealternates across the crystal, the crystal expands andcontracts, creating vibrations. This acoustic energyexits the transducer in a collimated beam pattern.

A special coupling gel or water is used to facilitatetransmission of the ultrasound beam from thetransducer to the patient’s skin. Some units are water-tight, allowing for underwater therapy. Not using gelor water, or using an inadequate amount, will causeheat at the transducer-skin interface instead of in theunderlying tissues, possibly burning the patient.

Most units allow selection of a continuous mode, inwhich the output power is constant, or a pulsed mode,in which the output is switched on and off; the pulserate is typically 60 to 120 pulses per second (pps),although some units operate at a higher or lower rate.Pulsed waves are further characterized by the dutycycle, the percentage of time that ultrasound waves arepresent during a pulsed period. Typical duty cyclesrange from 5% to 50%. Because the output power of apulsed waveform averaged over the on-and-off phaseof the cycle is lower, it causes less heating than acontinuous output on the same setting. This meansthat the pulsed setting has fewer thermal effects. Somestudies have associated a reduced healing time withpulsed ultrasound (Dyson 1987).

An important characteristic of the transducer is itsbeam nonuniformity ratio (BNR), which approximatesthe intensity across the transducer’s effective radiat-ing area (ERA) — the actual area of the transducerthat radiates ultrasound. The BNR is the ratio of themaximum point intensity on the transducer to theaverage intensity value across the transducer surface.Areas of high spatial intensities are known as “hotspots” and may cause excessive heating to the under-lying tissue. A lower BNR indicates a more even dis-tribution of energy from the transducer (see Fig. 1).

For correct application of ultrasound, thetransducer must be kept in constant motion, using

Distance from center of 10 cm transducer in mm2

Out

put

Inte

nsity

,%

100

80

60

40

20

0

C15

2UN

1A

20 2015 1510 105 50

Center

Figure 1. Curve of ultrasonic field output across thetransducer’s surface (shown greater than actual scale)

Healthcare Product Comparison System

2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.

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either a stroking motion or an overlapping circularmotion (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 mayalso lead to the formation of standing waves, whereinthe incident wave and the waves reflected from thetissue interface in the body are superimposed on eachother so the peaks of both waves combine to eitherincrease the effect or cancel out the waves. Standingwaves can damage the tissues that surround the waveand may cause clots in smaller blood vessels (Dyson1987).

Since there is no direct indicator of internal tissuetemperature, the operator depends on patient feed-back to adjust the intensity of the treatment andprevent burns. The operator can, however, estimatethe 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 timerwhen there is insufficient coupling between thetransducer and the patient; they can also have anaudible and/or visible alarm to alert the user to theproblem. Some units also accommodate the use of twotransducers at a time either to treat two separate areason one patient or to treat two patients at once. Inaddition, some suppliers offer watertight transducersfor use in underwater therapy.

A neuromuscular electrical stimulator is electricallysimilar to a transcutaneous electrical nerve stimula-tion (TENS) unit (see the Product Comparison titledSTIMULATORS, ELECTROANALGESIC, TRANSCUTANE-OUS ELECTRICAL NERVE). An electronic generatortransmits pulses of energy through the sound head,which acts as the active electrode, and into the tissue.Pulse waveforms are monophasic (either positive ornegative) or biphasic; typically, a biphasic waveform isused in conjunction with ultrasound therapy. Thepulse rate is variable; generally, 80 to 150 pps are usedtherapeutically. The pulse amplitude is adjusted sepa-rately for each modality, allowing the maximum bene-fit from both modalities while maintaining patientcomfort.

Neuromuscular stimulation produces some localthermal and chemical changes in the patient; however,it is most often used to create a muscle contraction.When electrical stimulation is used in conjunction withultrasound, the active electrode can be manipulated toproduce a rhythmic contraction-release episode in themuscle or muscle group that is most affected by theinjury. The contraction-release acts as a pump andpromotes the removal of metabolic by-products, whichhelps reduce spasm and pain.

Some neuromuscular stimulators are available asintegral components of therapeutic ultrasound unitsand can be used in conjunction with the ultrasound.Combined therapy has been found to be useful inpreventing scar tissue formation in healing tissues andin permitting the user to focus on particular muscletrigger points for greater pain relief (Roy and Irvin1983). However, there is much controversy about thevalidity of these studies, and very little supportingliterature has been published.

Reported problemsUltrasound output may decline over time. The in-

strument should be inspected annually and followingany mechanical impact to the transducer (e.g., fromdropping) to ensure satisfactory output calibration.The transducer assembly is prone to deterioration andshould be checked frequently for proper transmissionand watertightness.

There have been reports of patient burns during theuse of ultrasonic units. These include both internalburns, caused by excess local heating, and skin burns,

Combined ultrasound unit and neuromuscularstimulator

Ultrasound Therapy Systems/Neuromuscular Stimulators

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

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caused by contact with a hot transducer or heating ofthe skin-transducer interface due to inadequate gel.

The intensity levels of ultrasonic therapy are gener-ally much higher than those of diagnostic ultrasonicequipment. Clinicians should therefore be aware ofpotential hazards (e.g., areas of insufficient blood flowthat cannot handle the increased metabolic activitycaused by ultrasonic treatment) and use ultrasoundwith care. Inefficient coupling caused by poor design,a defective crystal, or an insufficient amount of gel willalso cause heat to build up in the transducer andthereby reduce the number of sound waves radiatedinto the treatment site.

Therapeutic ultrasound is contraindicated for use invarious areas: the eye; the uterus during pregnancy;the testes; malignant tumors; the spinal cord; andareas over the heart, a pacemaker, joint replacementswith polyethylene or methyl methacrylate (a commonglue type), prostheses, or epiphyseal (growth) plates inpatients under the age of 20. In addition, ultrasoundapplication may damage tissue that has been subjectedto deep radiation treatments.

Therapists administering ultrasound treatment arealso exposed to vibrations passed through the housingof the transducer as they hold the applicator. Thesevibrations, known as parasitic radiation, may causeacute pain in the hand and finger joints of some thera-pists (Michlovitz 1996).

Purchase considerationsA purchaser has the option of buying a tabletop,

wall-mounted, or cart-mounted therapeutic ultra-sound unit. Some portable devices are also available ina carrying case or tote bag if the unit is to be used foroff-site therapy.

Ultrasound units with dual frequencies (i.e., 1 and3 MHz) provide a greater range of treatment capabili-ties. Some therapy systems come with only onetransducer, while others are equipped with severaltransducers of various diameters to facilitate treat-ment of different areas of the body.

Although ultrasound machines are relatively inex-pensive, costs associated with the following must alsobe considered: additional transducers, coupling gel,service (inspections and repairs), and a therapist.

Instead of buying separate units, purchasers canobtain a combination ultrasound/neuromuscularstimulator unit to reduce costs. These units allow theuser to choose therapeutic ultrasound only, neuromus-cular stimulation only, or a combination of the two.

Stage of developmentTherapeutic ultrasound has been used clinically

since the 1940s. Currently, most units are of solid-state design with digital controls. In 1993, the U.S.Food and Drug Administration updated its perform-ance standard for ultrasonic physical therapy prod-ucts, which requires these units to have a powerindicator, an autoshutoff timer, and labels indicatingthe BNR and ERA of the transducer. Some manufac-turers have also incorporated features such as self-calibration, output power control in response to tissueloading, and automatic shutoff in case of an overheatedtransducer and/or inadequate coupling.

Studies are being done to evaluate ultrasound usein phonophoresis — a method of delivering medica-tion through the skin to the site where the effect isdesired. Although the technique is commonly used,Byl (1995) concluded that more carefully designedresearch is needed to improve the ability to provideeffective treatment.

Bibliography

Byl NN. The use of ultrasound as an enhancer fortranscutaneous drug delivery: phonophoresis. PhysTher 1995 Jun;75(6):539-53.

Fletcher D. The fundamentals of ultrasound equip-ment. Biomed Inst and Tech 2002 Mar-Apr;36(2):129-32.

Gann N. Ultrasound: current concepts. Clin Manage1991 Jul-Aug;11(4):64-9.

Gersh MR. Electrotherapy in rehabilitation. Philadel-phia: FA Davis; 1992.

Hekkenberg RT, Reibold R, Zeqiri B. Development ofstandard measurement methods for essential prop-erties of ultrasound therapy equipment. UltrasoundMed Biol 1994;20(1):83-98.

Michlovitz SL, ed. Thermal agents in rehabilitation.3rd ed. Philadelphia: FA Davis; 1996:168-212.

Robinson AJ, Snyder-Mackler L. Clinical electrophysi-ology: electrotherapy and electrophysiologic testing.2nd ed. Baltimore (MD): Williams & Wilkins; 1994.

Rothstein J. The rehabilitation specialist’s handbook.Philadelphia: FA Davis; 1991:627-46.

Sicard-Rosenbaum L, Lord D, Danoff JV, et al. Effectsof continuous therapeutic ultrasound on growth andmetastasis of subcutaneous murine tumors. PhysTher 1995 Jan;75(1):3-11.

Healthcare Product Comparison System

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Sussman C. Physical therapy modalities and thewound recovery cycle. Ostomy Wound Manage 1992Mar;38(2):43-51.

Zeqiri B, Hodnett M. A new method for measuring theeffective radiating area of physiotherapy treatmentheads. Ultrasound Med Biol 1998 Jun;24(5):761-70.

Standards and guidelinesNote: Although every effort is made to ensure that thefollowing list is comprehensive, please note that otherapplicable standards may exist.

British Standards Institution. Specification for safetyof ultrasonic therapy equipment [standard]. BS5724:Section 2.5. 1985.

Canadian Healthcare Association. User guidelines forinterferential current therapy devices. H50-1/3-1993E. 1993.

Institute of Physics and Engineering in Medicine.Guidelines for the routine performance checking ofmedical ultrasound equipment. 58. 1988.

International Electrotechnical Commission. Medicalelectrical equipment — part 1: general require-ments for safety [standard]. IEC 60601-1 (1988-12).1988.

Medical electrical equipment — part 1: general re-quirements for safety. Amendment 1 [standard].IEC 60601-1-am1 (1991-11). 1991.

Medical electrical equipment — part 1: general re-quirements for safety. Amendment 2 [standard].IEC 60601-1-am2 (1995-03). 1995.

Medical electrical equipment — part 1: general re-quirements for safety. Section 1. Collateral stan-dard: safety requirements for medical electricalsystems. IEC 60601-1-1 (1992-06). 1992.

Medical electrical equipment — part 1: general re-quirements for safety. Section 1. Collateral stan-dard: safety requirements for medical electricalsystems. Amendment 1. IEC 60601-1-1-am1 (1995-11). 1995.

Medical electrical equipment — part 1: general re-quirements for safety. Section 2. Collateral standard:electromagnetic compatibility — requirements andtests. IEC 60601-1-2 (2001-09). 2001.

Medical electrical equipment — part 2-5: particularrequirements for the safety of ultrasonic therapyequipment. 2nd ed [standard]. IEC 60601-2-5 (2000-07). 1984 (revised 2000).

Testing and calibration of ultrasonic therapeuticequipment [standard]. 150. 1963.

TNO Prevention and Health. Development of standardmeasurement methods for essential properties ofultrasound therapy equipment. Ultrasound MedBiol 1994 Jan;20(1):83-98.

U.S. Department of Health and Human Services. Foodand Drug Administration. Performance standards forsonic, infrasonic, and ultrasonic radiation-emittingproducts. 21 CFR 1050. 2000.

Citations from other ECRI publications

Health Devices Alerts

This Product Comparison lists Health Devices Alerts(HDA) citations published since the last update of thisreport. Each HDA abstract is identified by an Acces-sion Number. Recalls and hazard reports include de-scriptions of the problem involved; abstracts of otherpublished articles are referenced by bibliographic in-formation. HPCS subscribers can call the Hotline foradditional information on any of these citations or torequest more extensive searches of the HDA database.

A4368 The U.K. Medical Devices Agency (MDA) is-sued a safety notice warning that the casing on theadapter plug of the Boots the Chemists Item Code38-08-920 units purchased in the U.K. in 1999 and 2000break away or totally detach, exposing live wires, withthe potential to cause electric shock to users. MDArecommends the following: (1) Identify and isolate anyaffected product purchased in 1999 or 2000. (2) Discon-tinue use of affected product, immediately switch thepower off at the main power supply, and remove theadapter plug from the main socket. (3) Return affectedproduct to the nearest Boots the Chemists outlet forrefund, repair, or replacement. Healthcare profession-als who become aware that their patients or clients areusing these devices should warn them about the poten-tial problem and advise them to take the above actions.For further information, contact Paul Tansley, BootsCompany PLC, by mail at the above address, by tele-phone at (0115) 949 2218, or by fax at (0115) 847 2825.Inquiries to MDA should be addressed to the MDAAdverse Incident Centre by mail at Hannibal House,Elephant and Castle, London SE1 6TQ, England; bytelephone at (0207) 972 8080; or by fax at (0207) 9728109. Source: Great Britain. Medical Devices Agency.Product recall: Boots pain therapy intrasound unit,item code 38-08-920. London: Department of Health;2001 Mar. 3 p. (Safety notice; no. SN2001[05])

Health Devices Inspection and Preventive MaintenanceSystem

Physical therapy ultrasound units. Procedure no. 470.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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

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Supplier information

Amrex

Amrex Electrotherapy Equipment [178844]641 E Walnut StCarson CA 90746-1227Phone: (310) 527-6868, (800) 221-9069Fax: (310) 366-7343E-mail: [email protected]: http://www.amrex-zetron.com

Bandelin Electronic

Bandelin Electronic GmbH & Co KG [173102]Heinrichstrasse 3-4D-12207 BerlinGermanyPhone: 49 (30) 768800Fax: 49 (30) 7734699E-mail: [email protected]: http://www.bandelin.com

Biorem

Biorem Physiotherapy [192812]via F Angrisani 18/AI-84043 Agropoli SAItalyPhone: 39 (0974) 827171Fax: 39 (0974) 824246Internet: http://www.bsbgroup.it

Celcom

Celcom Inc [277920]2-2-13 Tokoji-machiHakata-kuFukuoka 816-0096JapanPhone: 81 (92) 4718863E-mail: [email protected]

Chattanooga

Chattanooga GroupDiv Encore Medical Corp [101154]4717 Adams RdPO Box 489Hixson TN 37343-4001Phone: (423) 870-2281, (800) 592-7329Fax: (423) 875-5497E-mail: [email protected]: http://www.chattgroup.com

Diter-Elektroniikka

Diter-Elektroniikka Oy [172848]Hakkiskuja 10FIN-20300 TurkuFinlandPhone: 358 (2) 2539800Fax: 358 (2) 2384504E-mail: [email protected]: http://www.diter.com

Dynatronics

Dynatronics [105329]7030 Park Centre DrSalt Lake City UT 84121Phone: (801) 568-7000, (800) 874-6251Fax: (801) 568-7711E-mail: [email protected]: http://www.dynatronics.com

DynaWave

DynaWave Corp [102810]2520 Kaneville CtGeneva IL 60134-2506Phone: (630) 232-4945Fax: (630) 232-7042E-mail: [email protected]: http://www.inil.com/users/dynawave

Electro-Medical

Electro-Medical Supplies (Greenham) Ltd[171326]Limborough RoadWantage, Oxfordshire OX12 7ADEnglandPhone: 44 (1235) 772272Fax: 44 (1235) 763518E-mail: [email protected]: http://www.emslimited.co.uk

Electromedicarin

Electromedicarin SA [230811]Poligono Industrial Can VolartCalle Torre de Cellers 6 Nave 2E-08150 Parets del Valles (Barcelona)SpainPhone: 34 (93) 5730724Fax: 34 (93) 5730331E-mail: [email protected]: http://www.electromedicarin.com

Healthcare Product Comparison System

6 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.

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Elmed

Elmed Inc [101348]60 W Fay AveAddison IL 60101-5106Phone: (630) 543-2792Fax: (630) 543-2102E-mail: [email protected]: http://www.elmed.com

Enraf-Nonius

Enraf-Nonius bv [295028]Roentgenweg 1Postbus 810NL-2600 AV DelftThe NetherlandsPhone: 31 (15) 2698400Fax: 31 (15) 2561686E-mail: [email protected]: http://www.enraf-nonius.com

Enraf-Nonius Medical Equipment Co Ltd[303456]984/22-27 TSST BuildingSukhumvit 71 Road Klongton Nua WattanaBangkok 10110ThailandPhone: 66 (2) 7133366Fax: 66 (2) 7132145E-mail: [email protected]: http://www.enraf-nonius.com

Enraf-Nonius NV/SA [333675]Ingberthoeveweg 3dB-2630 AartselaarBelgiumPhone: 32 (3) 4500070Fax: 32 (3) 4500075E-mail: [email protected]: http://www.enraf-nonius.com

Enraf-Nonius SA [333676]15 rue Paul LangevinZone d’Activites les BeaudottesF-93274 Sevran CedexFrancePhone: 33 (1) 49361818Fax: 33 (1) 43847649E-mail: [email protected]: http://www.enraf-nonius.com

ERBE Elektromedizin

ERBE Elektromedizin GmbH [156988]Waldhoernlestrasse 17D-72072 TuebingenGermanyPhone: 49 (7071) 7550Fax: 49 (7071) 755179E-mail: [email protected]: http://www.erbe-med.de

Hero Medical

Hero Medical Pty Ltd [177031]PO Box 441ElwoodMelbourne, VIC 3184AustraliaPhone: 61 (3) 95318788Fax: 61 (3) 95318788E-mail: [email protected]: http://www.hero.com.au

Innokas Medical

Innokas Medical Oy [330829]Tarjusojantie 10FIN-90440 KempeleFinlandPhone: 358 (8) 5623100Fax: 358 (8) 5623111E-mail: [email protected]: http://www.innokasmedical.fi

ITO

ITO Co Ltd [156029]3-3-3 Toyotama-MinamiNerima-kuTokyo 176-8605JapanPhone: 81 (3) 39944619Fax: 81 (3) 39941465E-mail: [email protected]: http://www.itolator.co.jp

ITO JV International (S) Pte Ltd [173130]63 Hillview Avenue07-20 Lam Soon Industrial BuildingSingapore 669569Republic of SingaporePhone: 65 7638233Fax: 65 7638200

Ultrasound Therapy Systems/Neuromuscular Stimulators

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

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KLD-Biosistemas

KLD-Biosistemas Equipamentos Eletronicos Ltda[174395]Avenida Europa 610 Jd CamanducaiaCaixa Postal 14013900-909 Amparo-SPBrazilPhone: 55 (19) 38079811Fax: 55 (19) 38079812E-mail: [email protected]: http://www.kld.com

KW Industria

KW Eletronica Ltda [174401]Avenida Augusto Barassa 1211Juliana13904-990 Amparo-SPBrazilPhone: 55 (19) 38075100Fax: 55 (19) 38076774E-mail: [email protected]: http://www.kweletronica.com

Laser Instruments

CTL-Laserinstruments [416026]ulica Wiosny Ludow 49PL-02-495 WarszawaPolandPhone: 48 (22) 8678801Fax: 48 (22) 8678748E-mail: [email protected]: http://www.ctl.com.pl

Metrax

Metrax GmbH [172393]Reinwaldstrasse 22D-78682 RottweilGermanyPhone: 49 (741) 2570Fax: 49 (741) 257235E-mail: [email protected]: http://www.metrax.de

Metron

Metron Medical Australia Pty Ltd [184653]57 Aster AvenuePO Box 2164Carrum Downs, VIC 3201AustraliaPhone: 61 (3) 97751234Fax: 61 (3) 97751990E-mail: [email protected]

Mettler Electronics

Mettler Electronics Corp [101504]1333 S Claudina StAnaheim CA 92805-6235Phone: (714) 533-2221, (800) 854-9305Fax: (714) 635-7539E-mail: [email protected]: http://www.mettlerelec.com

Nemectron

Nemectron GmbH [138326]Daimler Strasse 15D-76185 KarlsruheGermanyPhone: 49 (721) 97320Fax: 49 (721) 9732175E-mail: [email protected]: http://www.nemectron.de

Physiomed

Physiomed Electromedizin AG [285969]Postfach 48D-91218 Schnaittach/LaipersdorfGermanyPhone: 49 (9126) 258720Fax: 49 (9126) 258725E-mail: [email protected]: http://www.physiomed.de

Rich-Mar

Rich-Mar Corp [101645]PO Box 879Inola OK 74036-0879Phone: (918) 543-2222, (800) 762-4665Fax: (918) 543-3334E-mail: [email protected]: http://www.richmarweb.com

Skylark

Skylark Device & Systems Co Ltd [152424]12/Fl No 34 Chung Shan North Road Section 3TaipeiTaiwanPhone: 886 (2) 25979005Fax: 886 (2) 25912344E-mail: [email protected]: http://www.skylarkdevice.com

Healthcare Product Comparison System

8 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.

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TRUMPF

TRUMPF Medizin Systeme & Co KG [407177]Am Gansacker 1bD-79224 UmkirchGermanyPhone: 49 (7665) 98020Fax: 49 (7665) 980237E-mail: [email protected]: http://www.trumpf-med.com

TUR

TUR Elektromedizin GmbH [283034]Berliner Strasse 60D-16540 Hohen NeuendorfGermanyPhone: 49 (3303) 5260Fax: 49 (3303) 52612E-mail: [email protected]: http://www.elektromedizin.com

Uniphy

GymnaUniphy NV [394679]Pasweg 6aB-3740 BilzenBelgiumPhone: 32 (89) 510510Fax: 32 (89) 510511E-mail: [email protected]: http://www.gymna-uniphy.com

XLTEK

XLTEK [375502]2568 Bristol CircleOakville ON L6H 5S1CanadaPhone: (905) 829-5300, (800) 387-7516Fax: (905) 829-5304E-mail: [email protected]: http://www.xltek.com

XLTEK Korea Co Ltd [266253]Kangnam-gu Do-Kok Gong 951-33So-Hun Building No 202Seoul 101-752Republic of KoreaPhone: 82 (2) 5382443E-mail: [email protected]: http://www.xltek.com

Zimmer

Zimmer Electromedical Corp [243015]25 Mauchly Suite 300Irvine CA 92618-2331Phone: (949) 727-3356, (800) 327-3576Fax: (949) 727-2154E-mail: [email protected]: http://www.zimmerusa.com

Zimmer Elektromedizin GmbH [232380]Junkersstrasse 9D-89231 Neu-UlmGermanyPhone: 49 (731) 9761291Fax: 49 (731) 9761299E-mail: [email protected]: http://www.zimmer.de

Note: The following companies did not provide uswith any product information in time for publication.Their addresses are listed as a service to our readers.

Cosmogamma srl [152467]via Govoni 8/AI-40066 Pieve di Cento BOItalyPhone: 39 (051) 975054Internet: http://www.cosmogamma.com

R J Lindquist Co [102114]2419 W 9th StLos Angeles CA 90006-2004Phone: (213) 382-1268Fax: (213) 382-0958

About the chart specificationsThe following terms are used in the chart:

Maximum output, W: The maximum ultrasonic energyradiated by the transducer, expressed in watts.

Maximum intensity, W/cm2: The maximum energy ra-diated per unit area, expressed in watts per squarecentimeter.

Duty cycle, %: The pulse duration (time on) divided bythe entire pulse period (time on + time off).

Pulse rate, pps: The repetition frequency of waves,expressed in pulses per second.

BNR: The beam nonuniformity ratio, or ratio of themaximum to average intensity across thetransducer surface; a lower number indicates moreuniform output from the transducer.

Transducer, number: The number of transducers avail-able; one transducer is included in the price, and theothers are optional.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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ERA, cm2: The effective radiating area of thetransducer, expressed in square centimeters.

Multifrequency capability: The ability of a dual-frequency unit’s transducer to emit both frequen-cies through the same treatment head.

Plug-in/hardwired: The transducer is either perma-nently wired or simply plugged into the unit.

Abbreviations:

CE — Communaute Europeen

CE mark — Conformite Europeene mark

CETL — Canadian ETL Testing Laboratories

CISPR — Comite International Special des Pertur-bations Radioelectriques

CSA — Canadian Standards Association

CUL — Canadian Underwriters Laboratories

EEC — European Economic Community

EN — European Norm

ETL — ETL Testing Laboratories

EU — European Union

FCC — U.S. Federal Communications Commission

FDA — U.S. Food and Drug Administration

GS — Gepruefte Sicherheit

IEC — International Electrotechnical Commission

ISO — International Organization for Standardi-zation

LCD — Liquid crystal display

LED — Light-emitting diode

MDD — Medical Devices Directive

Ni-Cd — Nickel-cadmium

SEV — Schweizerischer Electrotechnischer Verein

TENS — Transcutaneous electrical nerve stimulation

TUV — Technischer Ueberwachungs Verein

UL — Underwriters Laboratories

VDE — Verband Deutscher Electrotechniker

VGA — Video graphics array

Note: The data in the charts derive from suppli-ers’ specifications and have not been verified throughindependent testing by ECRI or any other agency.Because test methods vary, different products’ specifi-cations are not always comparable. Moreover, prod-ucts and specifications are subject to frequent changes.ECRI is not responsible for the quality or validity ofthe information presented or for any adverse conse-quences of acting on such information.

When reading the charts, keep in mind that, unlessotherwise noted, the list price does not reflect supplierdiscounts. And although we try to indicate whichfeatures and characteristics are standard and whichare not, some may be optional, at additional cost.

For those models whose prices were supplied to usin currencies other than U.S. dollars, we have alsolisted the conversion to U.S. dollars to facilitate com-parison among models. However, keep in mind thatexchange rates change often.

Need to know more?For further information about the contents of this

Product Comparison, contact the HPCS Hotline at +1(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); [email protected] (e-mail).

Healthcare Product Comparison System

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Product Comparison Chart

MODEL AMREX AMREX AMREX BANDELIN ELECTRONIC

SYNCHROSONIC SYNCHROSONIC SYNCHROSONIC UltraPuls HU/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

OUTPUTFrequency, MHz 1 1 1 0.043Maximum 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) * YesPulsed beam Yes Yes Yes YesDuty cycle, % 100 : 50 50 50 75

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

TRANSDUCERNumber 1 1 1 1ERA, cm2 4 4 4 20Multifrequency

capability No No No NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No : Optional, with Yes Yes No

external stimulator

POWER SOURCE, VAC 120/220 120/220 120/220 240Hz 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 forhead; wall bracket, head; wall bracket, head; wall bracket, wound cleaning andutility cart, quick- utility cart, quick- utility cart, quick- healing stimulation;connect transducer connect transducer connect transducer transducer designedcable optional; cable optional; cable optional; to be waterproofstandard 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.

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Product Comparison Chart

MODEL BANDELIN ELECTRONIC BIOREM BIOREM CELCOMFAILED 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, Tabletopcart cart

OUTPUTFrequency, MHz 0.068 1, 3 1, 3 1Maximum 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 specifiedPulsed beam Yes Yes Yes Not specifiedDuty 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 specifiedBNR 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

TRANSDUCERNumber 1 1 3 Not specifiedERA, cm2 3 5 5, 50 Not specifiedMultifrequency

capability No Yes Yes Not specifiedPlug-in/hardwired Plug-in Plug-in Plug-in Not specified

NEUROMUSCULARSTIMULATOR No Optional Optional Yes

POWER SOURCE, VAC 240 100/240 100/240 100-240Hz 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 specified385 (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 withdisorders; tranducer autodiagnosis. wide controldesigned to be surfaces; can bewaterproof (IP 67). applied in a fixed

way with commonelastic 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).

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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 Portablebattery option

OUTPUTFrequency, MHz 1, 3.3 1, 3.3 1, 3.3 1, 3.3Maximum output, W 20 20 20 20

Maximum intensity,W/cm2 2.5 2.5 2.5 2.5

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100 10, 20, 50, 100

Pulse rate, pps 100 100 100 100BNR <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

TRANSDUCERNumber 3 3 3 3ERA, cm2 2, 5, 10 2, 5, 10 2, 5, 10 2, 5, 10Multifrequency

capability Yes Yes Yes YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Yes Output jack Output jack Output jack

POWER SOURCE, VAC 90-260 90-260 90-260 90-260Hz 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-calibratingself-calibrating able Ni-Cd ultrasound; head ultrasound; headultrasound; built-in batteries; self- contact control. contact control;clinical protocols calibrating built-in clinicaland remote control. ultrasound; built-in protocols.

clinical protocols.

Colons separate data on similar models of a device.

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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

OUTPUTFrequency, MHz 1, 3.3 1, 3.3 1, 3.3 1, 3.3Maximum output, W 20 20 20 20

Maximum intensity,W/cm2 2.5 2.5 2.5 2.5

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty 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 100BNR <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

TRANSDUCERNumber 3 3 3 3ERA, cm2 2, 5, 10 2, 5, 10 2, 5, 10 2, 5, 10Multifrequency

capability Yes Yes Yes YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Yes Yes Output jack Yes

POWER SOURCE, VAC 90-260 90-260 90-260 90-260Hz 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-calibratingultrasound; head ultrasound. ultrasound. ultrasound; gelcontact control; warmer; built-inbuilt-in clinical clinical protocols.protocols; remotecontrol included.

Colons separate data on similar models of a device.

Healthcare Product Comparison System

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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 WorldwideMiddle East

FDA CLEARANCE Yes Not specified Yes Yes

CE MARK (MDD) No Yes Yes Yes

CONFIGURATION Cart included Tabletop Portable Portable

OUTPUTFrequency, MHz 1, 3.3 0.9, 2, 3 1, 2, 3 1, 2, 3Maximum output, W 20 9 continuous, 12 20 20

pulsedMaximum intensity,

W/cm2 2.5 2 20 20

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 20, 50, 100 Not specified 10, 20, 50, continu- 10, 20, 50, continu-

ous ousPulse rate, pps 100 16, 48, 100 100 100BNR <6 Not specified <6 <6

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

OUTPUT POWER DISPLAY Color VGA Not specified Digital Digitaltouchscreen

TRANSDUCERNumber 3 1 Up to 4 Up to 4ERA, cm2 2, 5, 10 6; 1.3 optional 1, 2, 5, 10 1, 2, 5, 10Multifrequency

capability Yes Yes 1, 2, 3 MHz 1, 2, 3 MHzPlug-in/hardwired Plug-in Not specified Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Yes Not specified Possible with Yes

interconnection

POWER SOURCE, VAC 90-260 110-120/220-240 120/240 120/240Hz 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 beultrasound; gel microprocessor; modified during modified duringwarmer; 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 includesCSA and FCC Part 18 interferential andverification. combination therapy.

Colons separate data on similar models of a device.

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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

OUTPUTFrequency, MHz 1 1 1 1Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 5-50 25, 50, 75 5-50 20

Pulse rate, pps 10 30 10 10BNR 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

TRANSDUCERNumber 1 1 1 1ERA, cm2 10 * 10 * 10 * 8Multifrequency

capability No No No NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Yes No No Yes

POWER SOURCE, VAC 115 ** 115 115 ** 115Hz 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 mobileindicator for output regardless indicator for cart.open/short circuit, of tissue density; open/short circuit,overheated, or automatic treatment overheated, ordetuned transducer; suspension for detuned transducer;includes constant inadequate coupling; constant powerpower output audiovisual coupling output regardless ofregardless 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.

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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

OUTPUTFrequency, MHz 1, 3 1 or 3 : 1, 3 1, 3 1Maximum output, W 10 10 10 15

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

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty 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

TRANSDUCERNumber 2 1 : 2 2 1ERA, cm2 0.5, 5 5 : 0.5, 5 0.5, 5 6Multifrequency

capability Yes No : Yes Yes NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in (3)

NEUROMUSCULARSTIMULATOR 2/4 pole No Optional No

interferential

POWER SOURCE, VAC 100/240 100/240 100/240 110/220Hz 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 soundplus a treatment head; ultrasoundhead (ML9120 or feedback contactML9130, 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.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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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

OUTPUTFrequency, MHz 1 1 1, 3 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty 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

TRANSDUCERNumber Up to 2 Up to 2 (1) Up to 2 Up to 2ERA, cm2 1.6, 6 1.6, 6 1.6, 6 1.6, 6Multifrequency

capability No No No NoPlug-in/hardwired Plug-in (3) Plug-in (3) Plug-in (3) Plug-in (3)

NEUROMUSCULARSTIMULATOR Yes Yes No Yes

POWER SOURCE, VAC 110/220 110/220 110/220 110/220Hz 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 feedbackoperation; 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 soundbration head; para- head; parameters can head; parameters can head; parameters canmeters can be modi- be modified during be modified during be modified duringfied 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.

Healthcare Product Comparison System

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Product Comparison Chart

MODEL ELMED ELMED ELMED ELMED

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

OUTPUTFrequency, MHz 1 1 1 1Maximum output, W 18 18 18 18

Maximum intensity,W/cm2 3 3 3 3

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 50 50 50 50

Pulse rate, pps 120 120 120 120BNR 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

TRANSDUCERNumber 1 1 1 1ERA, cm2 6 6 6 6Multifrequency

capability Not specified Not specified Not specified Not specifiedPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR 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 withseparate stimulator voltage stimulator low-voltage faradic low-voltage faradicunit on cart; auto- in modular cabinet stimulator in stimulator; hasmatic transducer with mobile cart. modular cabinet; automatic shutoffshutoff. mobile cart switch in the trans-

available. ducer cradle.

Colons separate data on similar models of a device.* Others available.

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Product Comparison Chart

MODEL ELMED ELMED ENRAF-NONIUS ENRAF-NONIUSFAILED 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

OUTPUTFrequency, MHz 0.875 0.875 1 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 25 25 5-80 5-80 (continuous)

Pulse rate, pps 29 30 100 100BNR 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

TRANSDUCERNumber 1 1 1 2ERA, cm2 4 1, 4 5 0.8, 5Multifrequency

capability Not specified Not specified No YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Yes No Fixed No : Yes

POWER SOURCE, VAC 117 117 ** 110-120/220-240 110-120/220-240Hz 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; 10diadynamic 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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Product Comparison Chart

MODEL ENRAF-NONIUS ENRAF-NONIUS ERBE ELEKTROMEDIZIN ERBE ELEKTROMEDIZINFAILED TO RESPOND * FAILED TO RESPOND *Sonopuls 590 : Sonopuls 992+ Erbogalvan E2 Erbosonat ComfortSonopuls 591 VAK Plus

WHERE MARKETED Worldwide Worldwide Worldwide, except Worldwide, exceptUSA USA

FDA CLEARANCE Yes No No No

CE MARK (MDD) Yes Yes CE 0124 CE 0124

CONFIGURATION Tabletop, portable, Tabletop, portable, Tabletop or with Tabletopcart cart movable trolley

OUTPUTFrequency, MHz 1, 3 1, 3 1 1Maximum output, W 15 15 7.5 cont unmodulated 15

15 pulse modulatedMaximum intensity,

W/cm2 2 cont, 3 pulsed 2 cont, 3 pulsed 1.5 pulse modulated, 1.5 continuous, 33 continuous pulsed

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 20 20 10, 20, 33 10, 20, 33

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

TRANSDUCERNumber 4 2 2 2ERA, cm2 0.5, 0.8, 5 0.8, 5 2.5, 5 2.5, 5Multifrequency

capability No Yes Not specified Not specifiedPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR 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 requirementscombination therapy; nels; protocols for of EU Directive 93/ of IEC 601-1 and VDEcontact 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.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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Product Comparison Chart

MODEL HERO MEDICAL HERO MEDICAL HERO MEDICAL INNOKAS MEDICALFAILED TO RESPOND *

DM1 : DM2 DM 3 DP 1 PTC 2100 Ultrasound

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide, exceptUSA

FDA CLEARANCE No No No Not specified

CE MARK (MDD) Not specified Not specified Not specified Yes

CONFIGURATION Tabletop Tabletop Portable Tabletop

OUTPUTFrequency, MHz 1 1 and 3 1 1, 3Maximum output, W 15 15 2.5 15

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

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 1-100 : 50 1-100 50 11, 14, 20, 33, 50

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

TRANSDUCERNumber 1 2 1 2ERA, cm2 5 5 2.5 2.1, 4.7Multifrequency

capability No Yes No NoPlug-in/hardwired Hardwired Plug-in Hardwired Plug-in

NEUROMUSCULARSTIMULATOR No No No Combination

available

POWER SOURCE, VAC 110/240 110/240 110/240 110/240Hz 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 8 x 4 x 3 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 specifiedAU$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 controlpersonal use. reduces power if

poor couplingbetween sound headand patient; soundheads individuallycalibrated by com-puter; calibrationdata stored insidesound head.

Colons separate data on similar models of a device.* Specifications current as of September 1999.

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Product Comparison Chart

MODEL ITO ITO KLD BIOSISTEMAS KLD BIOSISTEMAS

US-100 US-700 Avatar 1-1MHz Avatar 1-EstheticTUS0101 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

OUTPUTFrequency, MHz 0.8 1, 3 1 2.5Maximum 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 YesPulsed beam Yes Yes yes YesDuty cycle, % 2.9 ±30 5, 10, 20, 30, 50 20 20

Pulse rate, pps 100 100 100 100BNR <4 <4 <8 <8

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

OUTPUT POWER DISPLAY LCD LCD LED LED

TRANSDUCERNumber 2 2 1 1ERA, cm2 0.8, 4 0.9, 5.5 3 3Multifrequency

capability No Yes No NoPlug-in/hardwired AC adapter Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No Optional No No

POWER SOURCE, VAC 110-240 110-240 120/220 120/220Hz 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 soundsource; 10 preset memories; treatment head. head; product mar-programs; 1 free protocols; automatic keted for cellulitisuser-programmable contact control; and lymphodrainage.memory; auto automaticcontact control; calibration.adjustable coupling CE mark.sensitivity; LCDscreen; automaticcalibration.

Colons separate data on similar models of a device.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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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 5TUS0201 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

OUTPUTFrequency, MHz 1 2.5 1, 2.5 1, 3Maximum output, W 15 15 15 15

Maximum intensity,W/cm2 3 3 3 3

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 5, 10, 20 5, 10, 20 5, 10, 20 5, 10, 20

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

TRANSDUCERNumber 1 1 2 6ERA, cm2 3 3 3 1, 3, 5Multifrequency

capability No No No NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No No Connector for Connector for

external stimulator external stimulator

POWER SOURCE, VAC 120/220 120/220 120-220 120-220Hz 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 soundhead; auto contact head; product mar- heads; product mar- heads; constantcontrol; 8 program- keted for cellulitis keted for cellulitis power output; auto-mable positions. and lymphodrainage; and lymphodrainage; corrected accordingMeets 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.

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Product Comparison Chart

MODEL KLD BIOSISTEMAS KLD BIOSISTEMAS KW INDUSTRIA KW INDUSTRIA

US 9002 US 9005 Liposonomaster SonomasterDual 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

OUTPUTFrequency, MHz 1 1, 3 3 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 5, 10, 20 5, 10, 20 20 10, 20, 50

Pulse rate, pps 128 128 100 16, 100BNR 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

TRANSDUCERNumber 1 2 2 2ERA, cm2 4 4 4 4Multifrequency

capability Not specified Not specified No YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No Optional No No

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

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Product Comparison Chart

MODEL KW INDUSTRIA KW INDUSTRIA KW INDUSTRIA LASER INSTRUMENTS

Sonomaster Sonomaster Standard Sonomaster Standard CTL-1107Microcontrolado 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

OUTPUTFrequency, MHz 1, 3 1 1 : 3 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 20, 50 20 20 12.5, 25, 50

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

TRANSDUCERNumber 1 1 1 2ERA, cm2 4 4 4 5, 10Multifrequency

capability Yes No No Not specifiedPlug-in/hardwired Plug-in Plug-in Plug-in Not specified

NEUROMUSCULARSTIMULATOR No No No Yes

POWER SOURCE, VAC 110/220 120/220 110/220 120/240Hz 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 clinicalcertified. protocols; trans-

ducer designed to bewaterproof; can becombined withseparate stimulatorunit.

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

OUTPUTFrequency, MHz 1 1 1, 3 1Maximum output, W 15 15 15 15

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

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10-100 10, 20, 50 10, 20, 50 50

Pulse rate, pps 50, 100 50 50 50/60BNR Not specified 6 6 6

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

OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCERNumber 2 1 2 1ERA, cm2 2, 5 5 0.75, 5 5Multifrequency

capability No No Yes NoPlug-in/hardwired Plug-in Hardwired Plug-in Hardwired

NEUROMUSCULARSTIMULATOR No Optional Optional Optional

POWER SOURCE, VAC 110/120/220/240 110/220/240 110/220/240 110/220/240Hz 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 certifiedmanufacturer. manufacturer. manufacturer.

Colons separate data on similar models of a device.

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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

OUTPUTFrequency, MHz 1 1, 3.3 1, 3.2, 3.3 1, 3.2, 3.3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 20 20 20 20, 50

Pulse rate, pps 100 100 100 100BNR 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

TRANSDUCERNumber 1 4 3 3ERA, cm2 5 : 10 1, 5, 10 * 1, 5, 10 * 1, 5, 10 *Multifrequency

capability No Yes Yes YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Optional Optional Yes Yes

POWER SOURCE, VAC 115/230 115/230 90-240 90-240Hz 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 ofcoupling between coupling between stimulation with stimulation withpatient & applicator patient & applicator ultrasound; up to ultrasound; up todetected; LED poor- detected; LED poor- 3 treatment proto- (3 : 5) treatmentcoupling indicator; coupling indicator; cols may be run at protocols may run atcart and tote bag universal applicator same time. Meets re- same time. Conformsavailable. Meets cable. Meets re- quirements of CETL, to CETL, CSA C22.2requirements 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, andIEC, 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.

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Product Comparison Chart

MODEL NEMECTRON NEMECTRON NEMECTRON PHYSIOMED

Nemectroson Nemectroson Nemectroson IONOSON110 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

OUTPUTFrequency, MHz 1, 3 1, 3 1, 3; 1-3 stochastic 1Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 5, 10, 20, 50 5, 10, 20, 50 5, 10, 20, 50 10, 33, 40, 50

Pulse rate, pps 100 100 100 Not specifiedBNR 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

TRANSDUCERNumber 2 2 4 2ERA, cm2 3.6, 4 3.6, 4 3.6, 4 2.5, 5Multifrequency

capability Yes Yes Yes NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR 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 andlost for >1 sec, lost for >1 sec, lost for >1 sec, ultrasound.reactivated with reactivated with reactivated withresumed contact; resumed contact; resumed contact;self-calibration and self-calibration and self-calibration andcontact 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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Product Comparison Chart

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

OUTPUTFrequency, MHz 1, 3 1, 3 1 1, 3Maximum output, W 15 15 2.5 8

Maximum intensity,W/cm2 3 3 1 2

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 33, 40, 50 10, 30, 40, 50 10, 33, 40, 50 10, 20, 50

Pulse rate, pps 100 100 100 40, 80, 200BNR <6 <6 <6 5.5 : 1

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

OUTPUT POWER DISPLAY Digital Digital Digital Digital

TRANSDUCERNumber 2 2 1 4ERA, cm2 2.5, 5 2.5, 5 2.5 4Multifrequency

capability Yes Yes No YesPlug-in/hardwired Plug-in Plug-in Plug-in Hardwired

NEUROMUSCULARSTIMULATOR Yes No No No

POWER SOURCE, VAC 115/230 ±10% 115/230 ±10% 115/230 ±10% 115/230Hz 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 yearsoptional

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.

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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 orhanging, portable portable mount wall mount

OUTPUTFrequency, MHz 1, 3 1, 3 1, 3 1Maximum output, W 8 8 4, 10 10 : 20

Maximum intensity,W/cm2 2 2l 2 2

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 20, 30 10, 20, 30 10, 15, 20, 25, 10, 15, 20, 25,

30, 35 30, 35Pulse rate, pps 40, 80, 200 40, 80, 200 40-140 40-140BNR 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

TRANSDUCERNumber 4 * 4 2 1ERA, cm2 3.5 4 2, 5 5 : 10Multifrequency

capability Yes Yes Yes NoPlug-in/hardwired Hardwired Hardwired Hardwired Hardwired

NEUROMUSCULARSTIMULATOR No No No No

POWER SOURCE, VAC 115/230 115/230 120 120Hz 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; additionaloptional 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 soundhands-free ultra- hands-free ultra- sound heads. CSA head; portablesound; mimics human sound; mimics human certified. carrying case avail-application by mov- application by mov- able. CSA certified.ing the ultrasound ing the ultrasoundfield via micropro- field via micropro-cessor control over cessor control overmultiple crystals; multiple crystals;applicator secured applicator securedwith straps. with straps.

Colons separate data on similar models of a device.* 1 hands-free applicator.

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Product Comparison Chart

MODEL RICH-MAR RICH-MAR RICH-MAR SKYLARK

Therasound 3.1/3.2 Therasound 3.4 Therasound 3.5 SD-956 UltrasonicTherapeutic 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, Tabletopportable portable portable

OUTPUTFrequency, MHz 1 1, 3 1, 3 1, 3Maximum output, W 10, 20 10 4, 10 2, 7.6

Maximum intensity,W/cm2 2 2 2 2

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10, 20, 50 10, 20, 50 10, 20, 50 10, 50

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

TRANSDUCERNumber 1 1 1 with 2 sound heads 2ERA, cm2 5, 10 5 2, 5 1, 4.4Multifrequency

capability No Yes Yes NoPlug-in/hardwired Hardwired Hardwired Hardwired Plug-in

NEUROMUSCULARSTIMULATOR No No No No

POWER SOURCE, VAC 115/230 115/230 115/230 110, 220Hz 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 yearoptional 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 requirementsavailable. UL available. UL transducer; of CE 0434 and ISOcertified. certified. portable versions 9001/1994. NS-EN

available. UL 4-6001 revisioncertified. certified.

Colons separate data on similar models of a device.

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Product Comparison Chart

MODEL SKYLARK SKYLARK TRUMPF TRUMPFFAILED TO RESPOND * FAILED TO RESPOND *

SD-957 Ultrasonic SD-958 Ultrasonic DR BORN Impulsaphon Sonosan 50Therapeutic Unit Therapeutic Unit NT 50

WHERE MARKETED Europe, Far East, Europe, Far East, Worldwide, except Worldwide, exceptUSA USA USA USA

FDA CLEARANCE Yes Yes Not specified Not specified

CE MARK (MDD) Yes Yes Yes Yes

CONFIGURATION Portable Portable Tabletop Portable

OUTPUTFrequency, MHz 1 3 1 1Maximum output, W 1.8 1.2 15 15

Maximum intensity,W/cm2 0.45 0.3 3 3

Continuous beam No No Yes YesPulsed beam Yes Yes Yes YesDuty cycle, % 10 15 5, 10, 20, 100 10, 20, 100

Pulse rate, pps 100 100 100 100BNR 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

TRANSDUCERNumber 1 1 2 2ERA, cm2 4 4 2.5, 5 2.5, 5Multifrequency

capability No No No NoPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No No Connector for Connector for

external stimulator external stimulator

POWER SOURCE, VAC 110, 220 110, 220 115/230 115/230Hz 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 ofof CE 0434, and ISO of CE 0434, and ISO quality assurance. quality assurance.9001/1994. NS-EN 9001/1994. NS-EN4-4001 revision 4-6001 revisioncertified. 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).

Ultrasound Therapy Systems/Neuromuscular Stimulators

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Product Comparison Chart

MODEL TRUMPF TUR TUR TURFAILED TO RESPOND *Sonosan 100 Curatur 421 current- Sonotur 410 Sonotur 420

ultrasonic combo

WHERE MARKETED Worldwide, except Worldwide Worldwide WorldwideUSA

FDA CLEARANCE Not specified Not specified Not specified Not specified

CE MARK (MDD) Yes Yes Yes Yes

CONFIGURATION Portable Tabletop, cart Handheld Tabletop, cart

OUTPUTFrequency, MHz 1, 3 1 0.8 1Maximum output, W 13.5 @ 1 MHz, 6 cont 1.4 8 cont

6 @ 3 MHzMaximum intensity,

W/cm2 2.7 @ 1 MHz, 1.5 cont, 3 pulsed 1 cont 2 cont, 3 pulsed1.2 @ 3 MHz

Continuous beam Yes Yes Yes YesPulsed beam Yes Yes No YesDuty cycle, % 5, 10, 20, 100 10, 30 NA 10, 20, 30, 50

Pulse rate, pps 100 50 NA 50BNR 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 **

TRANSDUCERNumber 2 2 1 2ERA, cm2 2.5, 5 4; 1 optional 1 4; 1 optionalMultifrequency

capability Yes No No NoPlug-in/hardwired Plug-in Plug-in Hardwired Plug-in

NEUROMUSCULARSTIMULATOR 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 requestHz 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 soundquality assurance. heads; automatic after treatment; heads; automatic

shutoff (if poor automatic ultrasonic shutoff if poorcoupling detected); energy reduction if coupling detected;coupling indications poor coupling detec- coupling indicationsat sound head & LED ted; all functions at sound head andluminous band; self- combined in banana- LED luminous band;calibration by test shaped handle; 4 self-calibration bymodes. †† 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.

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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, exceptUSA USA USA

FDA CLEARANCE Not specified No No No

CE MARK (MDD) Yes Yes Yes Yes

CONFIGURATION Tabletop, cart Tabletop Tabletop Tabletop

OUTPUTFrequency, MHz 1 1, 3 1, 3 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty 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 100BNR 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

TRANSDUCERNumber 2 2 2 2ERA, cm2 4; 1 optional 4; 1 optional 4; 1 optional 4; 1 optionalMultifrequency

capability No Yes Yes YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR Optional with inter- Biphasic TENS, Biphasic TENS, No

connection interferential interferential

POWER SOURCE, VAC 230, 115 100/110/220/230/240 100/110/220/230/240 100/110/220/230/240Hz 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 acousticheads; automatic channels; coupling channels; coupling coupling control;shutoff if poor control on display control on display memory of 20coupling detected; and treatment heads; and treatment heads; treatments; can becoupling indications memory of 500 memory of 500 combined withat sound head; treatments; calcu- treatments; calcu- electrostimulationself-calibration by lation of effective lation of effective unit; calculation oftest 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.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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Product Comparison Chart

MODEL UNIPHY UNIPHY XLTEK XLTEK

Phyaction 793 Phyaction Supporta Ultra III/ Ultra IVUltra III-HV

WHERE MARKETED Worldwide, except Worldwide, except Worldwide WorldwideUSA USA

FDA CLEARANCE No No Not specified Not specified

CE MARK (MDD) Yes Yes Not specified Not specified

CONFIGURATION Tabletop Tabletop Cart Cart

OUTPUTFrequency, MHz 1, 3 1, 3 1, 3 1, 3Maximum 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 YesPulsed beam Yes Yes Yes YesDuty cycle, % 1-100 12.5, 25, 50, 100 10-90 10-90

Pulse rate, pps 100 100 10-100 10-100BNR <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

TRANSDUCERNumber 2 2 3 3ERA, cm2 4; 1 optional 4; 1 optional 2, 5, 10 2, 5, 10Multifrequency

capability Yes No Yes YesPlug-in/hardwired Plug-in Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR 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 120/240 120/240Hz 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 dosement 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.

Healthcare Product Comparison System

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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

OUTPUTFrequency, MHz 1, 3 0.8, 3 0.8, 3Maximum output, W 15 1, 10 1, 10

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

Continuous beam Yes Yes YesPulsed beam Yes Yes YesDuty cycle, % 10, 20, 30, 50 20, 50 20, 50

Pulse rate, pps 100 20, 50 20, 50BNR 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

TRANSDUCERNumber 3 2 2ERA, cm2 2, 5, 10 1, 3.3 1, 3.3Multifrequency

capability Yes No NoPlug-in/hardwired Plug-in Plug-in Plug-in

NEUROMUSCULARSTIMULATOR No, I/P jack Combination possible Yes

installed

POWER SOURCE, VAC 120/240 120/230 120/230Hz 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 insufficientcontrol. coupling; micro- coupling; micro-

processor control; processor control;self-diagnostics; self-diagnostics;user-defined program user-defined programmemory; 40 preset memory; LCD; carry-protocols; LCD; opt ing case; watertightcart and watertight sound heads; 7sound 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.

Ultrasound Therapy Systems/Neuromuscular Stimulators

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