Aspirators Ultrasononic - Ultrasound Surgical Units.PDF

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UMDNS Information

This Product Comparison covers the followingdevice terms and product codes as listed inECRI Institute’s Universal Medical DeviceNomenclature System™ (UMDNS™):

Aspirators, Ultrasonic [15-756] Ultrasound Surgical Units [18-049]

Aspirators Ultrasonic; Ultrasound Surgical Units

Scope of this Product Comparison

This Product Comparison covers general-purpose ultrasonic aspirators and ultrasonic surgical

cutter/coagulators. Phacoemulsification systems—a similar technology used exclusively in ophthalmology—are

covered in the Product Comparison titled Cataract Extraction Units, Phacoemulsification.

These devices are also called: therapeutic ultrasonic units, ultrasonic coagulation shears, ultrasonic

surgical cutter/coagulators, laparosonic coagulation shears, ultrasonic scalpels.

Purpose

Ultrasonic aspirators use mechanical ultrasonic vibration and an

irrigation/suction system to fragment and remove soft tissue and high-water-

content growths from various parts of the body. They are used during procedures

in which surgical blades or blunt dissection instruments might damage

surrounding healthy tissue or for cases in which a surgical laser would eradicate

a lesion, leaving no surgical specimen for pathologic evaluation.

Ultrasonic aspirators are used during neurosurgery, general surgery, and

gynecologic and orthopedic procedures. They are indicated for removing brain

and spinal cord tumors, hepatic cysts, and vulvar lesions, as well as for

performing partial nephrectomies, laparoscopic cholecystectomies, and spleen

and liver resections. Ultrasonic aspirators have also been used during endoscopic

nasal polypectomies.

Ultrasonic surgical cutter/coagulators use high-frequency mechanical

ultrasonic vibration to cut and coagulate tissue. They are indicated for cutting soft tissue with bleeding control

and minimal thermal injury. Applications for gynecologic surgery include adhesiolysis, myomectomy, ovarian

cystectomy, laparoscopically assisted vaginal hysterectomy, treatment of ectopic pregnancy, treatment of

endometriosis, and bilateral salpingectomy or salpingo-oophorectomy. Ultrasonic cutter/coagulators are also

used in general surgical procedures such as laparoscopic cholecystectomy, herniorrhaphy, Nissen fundoplication,

colectomy, adrenalectomy, splenectomy, and gastrointestinal surgical procedures.

Principles of operation

Ultrasonic aspirators

An ultrasonic aspirator, typically controlled by a footswitch, consists

of a control unit and a handpiece. The control unit houses an

ultrasound generator and a pump used for suction and irrigation. The

ultrasound generator produces an ultrasonic signal, which is sent to a

transducer. The signal is transformed into mechanical motion, vibrating

Comprehensive of Biomedical Engineering Site (www.dezmed.com

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Aspirators, Ultrasonic; Ultrasound Surgical Units

2 ©2008 ECRI Institute. All Rights Reserved.

the tip at a frequency of about 20 to 80 kHz. Control units can have either a console or tabletop configuration; a

combined cable and tubing set connects the control unit to the handpiece. The handpiece has either a piezoelectric

or a magnetostrictive transducer, which causes the hollow titanium tip to oscillate, fragmenting cellular matter.

Transducers are usually permanently housed inside the handpiece.

Handpieces are typically frequency specific, operating either at a low

frequency (e.g., 23 kHz) or a high frequency (e.g., 55 kHz). A lower-frequency, higher-amplitude probe is more effective in removing calcified

or elastic tissue, while a higher-frequency, lower-amplitude handpiece is

effective for soft- and medium-density tissue and can also accommodate

smaller tips for procedures that entail delicate dissections.

Ultrasonic surgical cutter/coagulators

Ultrasonic surgical cutter/coagulators consist of a control unit with a

high-frequency generator, an ultrasonic handpiece with a blade, and a

footswitch. The blade vibrates at a harmonic frequency of up to 55.5 kHz

to cut tissue. The ultrasonic vibrations denature protein and cause

coagulation through heat generation from internal cellular friction andthrough the breaking of tertiary hydrogen bonds as a result of the transfer

of mechanical energy to the tissue. Ultrasonic surgical cutter/coagulators

differ from ultrasonic aspirators in that they lack an irrigation/aspiration

system, are able to cut and coagulate tissue, and have different

handpieces and blades/tips.

Cavitational cutting

When the vibrating tip or blade of either device’s handpiece comes into contact with cells of high water

content, vapor pockets form within the cells, causing them to separate and eventually collapse. The aspirator and

cutter/coagulator have different effects on low-water-content, collagen-rich tissue, such as blood vessels or ducts.

These tissues remain virtually intact when they encounter the ultrasonic aspirator. Therefore, encapsulated andinvasive tumors can be delicately resected without injury to adjacent blood supplies. Manipulating the handpiece

allows the surgeon to determine the consistency of the tissue touching the tip, allowing very precise removal. The

cutter/coagulator creates a cavitational effect that facilitates dissection of certain types of tissue, such as removing

the gallbladder from the liver bed or a myoma from the uterus.

Fluidics system

The ultrasonic aspirator has a fluidic system that controls irrigation, aspiration, and cooling. Irrigation is

provided by a bottle of irrigant (saline or lactated Ringer’s) mounted on an adjustable intravenous pole. On most

units, the irrigation tubing passes through a solenoid valve that opens when the footswitch is pressed. Fluid then

flows through the irrigation tubing to the handpiece and through an irrigation sleeve, which surrounds the tip

and provides a flow path between the tip and the surgical site. The irrigant cools the tip of the handpiece during

surgery to prevent thermal trauma to the tissue and dilutes the fragmented tissue to prevent obstructions from

flowing into the handpiece or tubing.

The aspiration line runs from the handpiece to a vacuum pump and a collection container. Suction is used to

hold larger fragments to the tip, where they can be emulsified; irrigant and smaller fragments are then aspirated

into a collection container through the aspiration line.

Irrigation/aspiration (I/A) systems commonly use peristaltic, diaphragm, and venturi pumps to create a

vacuum. In most diaphragm and venturi pump systems, only the vacuum levels can be set; the rate at which


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©2008 ECRI Institute. All Rights Reserved 3

objects are drawn to the tip—the aspiration flow—can be changed only by adjusting these levels. Peristaltic pump

systems, on the other hand, can alter the flow by varying the pump speed; a separate vacuum control is used to

adjust the maximum vacuum at the probe tip.

Additional fluidic system components provide venting of the aspiration line to relieve vacuum (e.g., when the

surgeon stops aspiration by releasing the footswitch), as well as reflux to flush obstructions out of the aspiration

flow path and to move tissue away from the tip.

Aspirator handpiece configurations

Ultrasonic aspirator handpieces are lightweight, typically between 4 and 10 oz (113.4 and 284 g). Most

suppliers offer straight and angled configurations, often with extensions. Angled and extended probes can

facilitate access to areas that are difficult to reach or see (e.g., a deep-seated brain tumor). Some suppliers offer

handpieces that fit through a laparoscopic trocar cannula, and some offer 55.5 kHz handpieces that can coagulate.

Some handpieces are of one-piece construction, while others can be disassembled for cleaning and routine

maintenance. The transducers are either air- or water-cooled to prevent them from overheating. Irrigation and

aspiration lines may run along the outside or the inside of the casing; most handpieces can be steam sterilized,

while others are sterilized with ethylene oxide or gas plasma sterilization. Ultrasonic aspirator tips can be either

reusable or disposable and are generally flat at the operative end.The ability of a handpiece to emulsify tissue is determined by the amplitude (stroke length) and frequency of

the vibrating tip; the shape and sharpness of the tip; the ability of the handpiece to maintain the resonance, or

natural frequency, of the vibrating complex (consisting of the handpiece, the tip, and the object contacting the

tip); and the level of aspiration. Most ultrasonic systems have a continuous autotuning feature that allows the

generator to adjust its output signal to match the changing resonance of the handpiece system.

Cutter/coagulator handpiece configurations

The cutter/coagulator’s handpiece is connected to the generator by a shielded coaxial cable and consists of an

acoustic transducer, an acoustic mount, an extender covered by a protective sheath, and a blade. Electrical energy

causes the piezoelectric ceramic elements in the acoustic transducer to produce mechanical vibrations, which are

transmitted along the extender to the blade. The acoustic mount holds the transducer in place and prevents the

handpiece from vibrating. The reusable, limited-life handpiece is lightweight and can be sterilized. A number of

different blade types are available for different applications, including sharp hook, dissecting hook, ball

coagulator, and coagulating shear.

Ultrasonic aspirator controls

Front-panel controls for the ultrasonic aspirator are used to select power setting, vacuum limits, and irrigation

rates. These modes are used simultaneously during active ultrasonic aspiration; some models also have a standby

mode that allows for constant low-level irrigation and aspiration. In the ultrasonic (or vibration) mode, the unit

delivers the preset aspiration vacuum and ultrasound output levels immediately with footswitch activation

(preset control). In addition, by using the footswitch, the surgeon can individually control the vacuum orultrasound output level (linear control). For example, in the linear mode, the handpiece output is directly

proportional to the displacement of the footswitch in the ultrasound position.

Most ultrasonic aspirators control and display the status of irrigation, aspiration, and vibration. Many specify

error code messages for troubleshooting; these messages include clogged or damaged tips and handpiece

malfunctions, as well as suction, electronics, and footswitch problems.


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Cutter/coagulator controls

Ultrasonic cutter/coagulator controls include those for power level, standby/ready modes, audible indicator

volume, and display brightness. The power level, which can be adjusted using a footswitch, controls the

longitudinal excursion of the blade. A microprocessor in the generator adjusts the output frequency when it

senses impedance changes or changes in the harmonic frequency of the transducer. If the generator cannot adjust

for these changes, an audible alarm is signaled and the unit shuts down.

Reported problems

Some ultrasonic aspirator handpieces need to be disassembled for cleaning and routine maintenance. Special

accessories such as a torque wrench or handpiece holder are typically required for proper disassembly and

reassembly. Improper use of these accessories or improper reassembly can compromise the handpiece, resulting

in inefficient operation. Using an inappropriate handpiece for a given tissue density can also result in inefficient

operation.

There have been reports that ultrasonic aspirators and ultrasonic surgical units can produce a fine mist or

aerosols that may travel upward and potentially contaminate the environment and the staff. It is therefore

advisable that the surgical team wear protective eyewear and take other effective measures for infection control.Risks of contamination can also be minimized by using adequately upgraded instruments at optimal irrigation

and aspiration settings.

Acoustic energy coupling and overheating of the ultrasonic surgical cutter/coagulator shaft may occur if the tip

of the instrument gets bent, leading to an increase in potential risk for injury (Awwad and Isaacson 1996).

Bending can occur when steering the extender sheath, manipulating the device through a small-diameter

opening, or exerting pressure on the shaft. Overheating can also occur if the aspirator line is impaired. Care

should be taken while directing the device, and prompt attention should be given to malfunction signals.

In order to reduce costs, some hospitals may be tempted to purchase reprocessed ultrasonic scalpels from

reprocessed-device distributors. The purchase of any reprocessed medical device designed for single use must be

considered carefully, as safety and sterility is a greater concern.

Purchase considerations

E RI Institute’s recommendations

Included in the accompanying comparison charts are ECRI Institute’s recommendations for minimum

performance requirements for ultrasonic aspirators and ultrasound surgical units. Both ultrasonic aspirator and

ultrasound surgical unit transducer assemblies should be housed permanently in the handpieces. A piezoelectric

oscillation system operating at a maximum amplitude of 400 µm and a frequency of 20 to 80 kHz (for ultrasonic

aspirators) or 22 to 55.5 kHz (for ultrasound surgical units) is recommended. The handpiece blades or tips should

be constructed of titanium or titanium alloy metal.

Ultrasound surgical unit displays should include power level (setting), mode, and system status indicators

(e.g., alarms). Also the unit should have audible indicators and error code messages.

Ultrasonic aspirator fluidic systems should be capable of operating at a maximum vacuum of 700 mm Hg. The

footswitch control should possess both preset and linear modes. The aspirator should include power, vacuum,

irrigation level, and application time displays, as well as irrigation, aspiration, and ultrasound controls. The unit

should also have error code messages.


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Other considerations

Some ultrasonic aspirator systems are self-contained; they incorporate a vacuum pump and a standard suction

canister for holding aspirated tissue. Other systems may require hospital vacuum and suction systems.

Some systems require manual tuning before the tip is used. Once the tip encounters a change in mass (i.e., the

tissue), the unit may no longer be tuned to resonance. Other systems have a continuous autotuning function and

may or may not have a pre-use tuning button. Autotuning enables the ultrasonic generator to constantly change

its output to match the changing resonance of the handpiece, thereby eliminating the need for manual tuning and

increasing the efficiency of the ultrasound circuit and tip.

Because of the complexity of the technology, clinical evaluations should be performed before a purchase

decision is made to ensure that the surgeon is comfortable with the ultrasonic aspiration system. Handpieces are

generally chosen for particular clinical procedures on the basis of the size and weight of the handpiece and tip,

the consistency of the tumor or tissue to be removed, and the importance of minimizing damage to surrounding

tissues and structures. Each system has different performance characteristics, and its effectiveness depends on the

surgeon’s comfort level and familiarity with the system.

Service support should be readily available, and replacement or repair parts should be easily identified and

quickly obtainable from the supplier. The supplier should also offer free training (preferably on-site) for the

operation and maintenance of the unit and should provide the user with clear, concise, and comprehensive

instruction and service manuals.

Cost containment

The cost of ultrasonic aspiration systems varies greatly, not only because of differences in the initial price, but

also because of vast differences in the cost per procedure, which can include such items as handpiece tips and I/A

tubing sets. Many suppliers offer disposable handpiece tips, while others offer reusable tips that usually have a

limited number of uses.

Because ultrasonic aspirators entail ongoing maintenance and operational costs, the initial acquisition cost does

not accurately reflect the total cost of ownership. Therefore, a purchase decision should be based on issues such as

the average cost per procedure, cost of disposables, initial cost of reusables, cost per procedure for sterilization ofreusables, cost of additional handpieces, discount rates and non-price-related benefits offered by the supplier, and

local service support.

Hospitals can purchase service contracts or service on a time-and-materials basis from the supplier. Service

may also be available from a third-party organization. The decision to purchase a service contract should be

carefully considered. Purchasing a service contract ensures that preventive maintenance will be performed at

regular intervals, thereby eliminating the possibility of unexpected maintenance costs. Also, many suppliers do

not extend system performance and uptime guarantees beyond the length of the warranty unless the system is

covered by a service contract.

ECRI Institute recommends that hospitals negotiate pricing for service contracts before the system is

purchased.

Stage of development

Ultrasonic surgical aspiration was developed in 1967 by C.D. Kelman, an ophthalmologist who first used

ultrasonic technology in cataract extraction procedures (phacoemulsification). Ultrasonic aspiration is now used

for neurosurgery and many other surgical specialties; researchers are still exploring new applications. Ultrasonic

cutter/coagulators were introduced for sale in 1992 and are still a relatively new technology.

Some compact aspirators with smaller handpieces are now available. These devices may be more effective in

procedures that have a small operative field such as neurosurgery and laparoscopic surgery. The smaller probes


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allow a greater field of vision, and can be used with other surgical devices such as endoscopes or microsurgery

clamps.

Bibliography

Amaral JF. The experimental development of an ultrasonically activated scalpel for laparoscopic use. Surg

Laparosc Endosc 1994 Apr;4(2):92-9.

Awwad JT, Isaacson K. The harmonic scalpel: an intraoperative complication. Obstet Gynecol 1996 Oct;88(4 Pt

2):718-20.

Brock M, Ingwersen I, Roggendorf W. Ultrasonic aspiration in neurosurgery. Neurosurg Rev 1984;7(2-3):173-7.

ECRI. Intermittent operation of Elekta Selector ultrasonic aspirators *User Experience Network™+. Health Devices

1997 Dec;26(12):474-5.

Phacoemulsification systems [evaluation]. Health Devices 1989 Nov;18(11):377-404.

Suction canisters [evaluation]. Health Devices 1985 Dec;14(12):411-34.

Hakan P, Yuksel A, Bulent C, et al. Easy harvesting of radial artery with ultrasonically activated scalpel. Ann

Thorac Surg 1998 Apr;65(4):984-5.

Horowitz NS, Rader JS. Role of the ultrasonic surgical aspirator in gynecology. Obstet Gynecol Clin North Am 2001

Dec;28(4):775-90.

Muraki J, Addonizio JC, Lastarria E, et al. New Cavitron system (CUSA/CEM): its application for kidney surgery.

Urology 1993 Feb;41(2):195-8.

Nahhas WA. A potential hazard of the use of the surgical ultrasonic aspirator in tumor reductive surgery. Gynecol

Oncol 1991 Jan;40(1):81-3.

Nogler M, Lass-Florl C, Wimmer C. Contamination during removal of cement in revision hip arthroplasty. A

cadaver study using ultrasound and high-speed cutters. J Bone Joint Surg Br 2003 Apr;85(3):436-9.

Rosenberg SI. Use of the ultrasonic aspirator during endoscopic nasal polypectomy. Otolaryngol Head Neck Surg

1994 Jul;111(1):143-5.

Shiozawa H, Miki M, Tochimoto M. Newly developed ultrasonic aspirator and its application for endoscopic

surgery. J Endourol 1994 Aug;8(4):285-6.

Tulandi T, Chan KL, Arseneau J. Histopathological and adhesion formation after incision using ultrasonic

vibrating scalpel and regular scalpel in the rat. Fertil Steril 1994 Mar;61(3):548-50.

Ulmer BC. Ultrasonic surgical aspiration: an expanding method for patient treatment. AORN J 1993 Apr;57(4):865-

9.

van Dam PA, Coppens M, van Oosterom AT, et al. Is there an increased risk for tumor dissemination using

ultrasonic surgical aspiration in patients with vulvar carcinoma? Eur J Obstet Gynecol Reprod Biol 1994 Jun15;55(2):145-7.

Wetter LA, Payne JH, Kirshenbaum G, et al. The ultrasonic dissector facilitates laparoscopic cholecystectomy.

Arch Surg 1992 Oct;127(10):1195-9.

Yamakawa T, Kano N, Sakai S, et al. Preliminary experience using an ultrasonic aspirator for laparoscopic

cholecystectomy. Endoscopy 1992 Oct;24(8):721-3.

Yamasaki T, Moritake K, Nagai H, et al. A new, miniature ultrasonic surgical aspirator with a hand-piece

designed for transsphenoidal surgery. Technical note. J Neurosurg 2003 Jul;99(1):177-9.


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Supplier information

Chart A: Ul trasonic Aspi rators

INTEGRA LIFESCIENCES

Integra LifeSciences [150315]

311 Enterprise DrPlainsboro, NJ 08536-3344

Phone: (609) 275-0500, (800) 654-2873 Fax: (609) 275-5363

Internet: http://www.integra-ls.com

E-mail: [email protected]

MISONIX

Misonix Inc [184247]

1938 New Hwy

Farmingdale, NY 11735-1204

Phone: (631) 694-9555, (800) 694-9612 Fax: (631) 694-9412

Internet: http://www.misonix.com


SOERING

Soering Inc [369666]

6646 Ironhorse Blvd

North Richand Hill, TX 76180

Phone: (817) 514-4993, (866) 532-2392 Fax: (817) 514-4998

Internet: http://www.soering.com


Soering GmbH Medizintechnik [152723]

Justus-von-Liebig-Ring 10

Quickborn D-25451

GermanyPhone: 49 (4106) 61000 Fax: 49 (4106) 610010

Internet: http://www.soering.com


SOUND SURGICAL

Sound Surgical Technologies LLC [367463]

357 S McCaslin Blvd Suite 100

Louisville, CO 80027-2932

Phone: (303) 926-8608, (888) 677-8765 Fax: (303) 926-8615

Internet: http://www.soundsurgical.com


SYNERGETICS

Synergetics Inc [440152]

3845 Corporate Centre Dr

St Charles, MO 63304

Phone: (636) 939-5100, (800) 600-0565 Fax: (636) 939-6885

Internet: http://www.synergeticsusa.com



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http://www.integra-ls.com/



mailto:[email protected]



http://www.misonix.com/






http://www.soering.com/












http://www.soundsurgical.com/






http://www.synergeticsusa.com/





















Chart B: Ul trasound Surg ica l Uni ts

ETHICON

Ethicon Endo-Surgery Inc A Johnson & Johnson Co [149225]

4545 Creek Rd

Cincinnati, OH 45242

Phone: (513) 337-7000, (800) 873-3636 Fax: (513) 337-7912

Internet: http://www.ethiconendo.com


Ethicon Endo-Surgery (Scotland) A Johnson & Johnson Co [363930]

Simpson Parkway Kirkton Campus

Livingston EH54 7AT

Scotland

Phone: 44 (131) 453555 Fax: 44 (1506) 460902

Ethicon Endo-Surgery (Singapore) c/o Johnson & Johnson Medical [307283]

3 International Rd Jurong

Singapore 619619Republic of Singapore

Phone: 65 2658922

MEDICAMAT

Medicamat SA [281833]

59 avenue Augustin-Dumont

Malakoff F-92240

France

Phone: 33 (1) 46562404 Fax: 33 (1) 40929512

Internet: http://www.medicamat.com


U.S. SURGICAL

Covidien Auto Suture/United States Surgical/Syneture Div Covidien (US) [452301]

150 Glover Ave

Norwalk, CT 06856-5080

Phone: (203) 845-1000, (800) 722-8772 Fax: (203) 847-0635, (800) 544-8772

Internet: http://www.autosuture.com


Note: The data in the charts derive from suppliers’ specifications and have not been verified through

independent testing by ECRI Institute or any other agency. Because test methods vary, different products’

specifications are not always comparable. Moreover, products and specifications are subject to frequent changes.

ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse

consequences of acting on such information.When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier

discounts. And although we try to indicate which features and characteristics are standard and which are not,

some may be optional, at additional cost.

For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the

conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates

change often.

Last updated May 2008


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http://www.ethiconendo.com/






http://www.medicamat.com/






http://www.autosuture.com/
















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Chart A: Ultrasonic Aspirators

MODEL ECRI INSTITUTE'SRECOMMENDEDSPECIFICATIONS1

INTEGRA LIFESCIENCES INTEGRA LIFESCIENCES INTEGRA LIFESCIENCES

Ultrasonic Aspirators CUSA Dissectron CUSA EXcel CUSA Selector

WHERE MARKETED Worldwide, except USA Worldwide WorldwideFDA CLEARANCE Yes Yes YesCE MARK (MDD) Yes Yes YesSURGICAL INDICATIONS General, neurosurgery,

laparoscopy, liver surgery,ENT, gastroenterology,urology

Neurosurgery, general,gynecology, urology,laparoscopy, thoracic,gastrointestinal, orthopedic,thoracoscopic, plastic, andreconstructive surgery

Neurosurgery,gastroenterology (includinglaparoscopic procedures),gynecology, thoracic

CONFIGURATION Tabletop Console Console, optional servicemodule

TRANSDUCERASSEMBLY

Permanently housed inhandpiece




ULTRASONIC SYSTEMFrequency, kHz 20-80 29 23, 36 24, 35Maximum amplitude, µm 400 320 355 straight 23 kHz, 208

angled 23 kHz, 210 straight36 kHz

300, 190

Oscillation system Piezoelectric Piezoelectric Magnetostrictive PiezoelectricFLUIDIC SYSTEM

Aspiration, mm Hg 700 0-680 0-660 0-680Irrigation system Central Coaxial Central

Fluid Saline Saline SalineFlow rate, cc/min 0-16 1-29, variable 0-50

HANDPIECECONFIGURATIONS

Straight 29 kHz 23 and 36 kHz 24/35 kHzAngled 29 kHz 23 and 36 kHz 24/35 kHzStraight extended 29 kHz Extended tips 24 kHzAngled extended 29 kHz Angled extended tips 24 kHzOther Laparoscopic,

microhandpieceLaparoscopic tip, extendedlength tip for transnasalprocedures, bone-cutting tip

Laparoscopic, microsurgicalhandpiece

TIPType Titanium, titanium alloy Titanium Titanium TitaniumReusable/disposable Both Both Both

STERILIZATION Steam Steam/flash SteamFOOTSWITCH CONTROL Yes Yes Yes

Preset mode Yes Yes Yes NoLinear mode Yes No No Yes

This is the first of threepages covering the abovemodel(s). Thesespecifications continue ontothe next two pages.


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Ultrasonic Aspirators CUSA Dissectron CUSA EXcel CUSA SelectorDISPLAYS Power, vacuum, irrigation

levels, application timeIrrigation, aspiration, power,pulse mode, others optional

Irrigation, aspiration, power,TissueSelect, laparoscopicmode, default settings,alerts

Irrigation, aspiration, power,timer clock

CONTROLS Irrigation, aspiration,ultrasound

Irrigation, aspiration, power,pulse mode, coagulation(monopolar and bipolar)

Irrigation, aspiration, power,TissueSelect, laparoscopicmode, test, prime, alarmvolume, audio feedback,electrosurgical CEM

Irrigation, aspiration, power,clock reset

ERROR CODEMESSAGES

Yes Footswitch problem, power-supply problem, suctionfailure

Footswitch, handpiece,cooling water, vibration faultindicators

Handpiece error warning, tiperror warning

POWER REQUIREMENTSVAC 100/110/220/240 95/110/240 100-120/220-240Hz 50/60 50/60 50/60

Amp 2/4 10/5 5/2.5H x W x D, cm (in) 42 x 36 x 21 (16.5 x 14.2 x

8.3)117 x 55.9 x 65 (46 x 22 x25.5)

15 x 39 x 49 (5.9 x 15.3 x19.2)

WEIGHTUltrasonic system, kg(lb)

15 (33.1) 95.3 (210) 19.5 (43)

Handpieces, g (oz) <200 (7.05), 60 (2.1)microhandpiece

180 (6.35) 23 kHz, 60 (2.1)36 kHz

Neuro 125-190 (4.4-6.7);standard 160-220 (5.6-7.7);laparoscopic 278 (9.8)

PURCHASEINFORMATION

List price, standardconfiguration

Not specified Not specified Not specified

Warranty 1 year 1 year 1 yearTraining Not specified Included in purchase price Not specifiedDelivery time, ARO Not specified Not specified Not specifiedNumber sold Not specified Not specified Not specified

Year first sold Not specified 1998 1998Fiscal year Not specified Not specified Not specified

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Ultrasonic Aspirators CUSA Dissectron CUSA EXcel CUSA SelectorOTHER SPECIFICATIONS Medical Law Approval

(Japanese).Intraoperative tip changing;11 tip configurations for 36kHz handpiece: 3 standard,4 MicroTip/MicroTip plus, 1CUSA SaberTip bonecutting, and 3 PrecisionTip;6 tip configurations for 23kHz handpiece: 1 standard,1 MicroTip, 1 MacroTip, 1short, 1 curved extendedstandard, 1 straightextended standard, and 1laparoscopic; TissueSelect;CUSA electrosurgicalmodule; preaspiration holes

on tips; color-codedassembly; quick referencecards. Meets requirementsof BSI, CSA, IEC 601 and801, TUV, and UL 544.

Can use common suctioncanisters; optional servicemodule, sterilization tray.Meets requirements of BSEN ISO 9001/1994, BS EN46001/1994, IEC, and UL.

UMDNS CODE(S) 15756 15756 15756 15756LAST UPDATED May 2008 May 2008 May 2008Supplier Footnotes 1These recommendations

are the opinions of ECRIInstitute's technologyexperts. ECRI Instituteassumes no liability fordecisions made based onthis data.

Model Footnotes

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MODEL MISONIX SOERING SOERING SOERINGSonastar FS1000 RF SONOCA 150 SONOCA 180 SONOCA 185

WHERE MARKETED Asia, Europe, Middle East Worldwide, except USA Worldwide Worldwide, except USAFDA CLEARANCE Yes Not specified Yes Not specifiedCE MARK (MDD) Yes Yes Yes YesSURGICAL INDICATIONS General surgery,

neurosurgeryLiposuction, woundtreatment

Wound treatment Wound treatment

CONFIGURATION Console, 2 handpieces,wireless footswitch

Tabletop Tabletop with trolley Tabletop with trolley

TRANSDUCERASSEMBLY





ULTRASONIC SYSTEMFrequency, kHz 23 20-80 20-80 20-80Maximum amplitude, µm 345 200 peak 200 peak 200 peakOscillation system Piezoelectric Electrostrictive PZT Electrostrictive PZT Electrostrictive PZT

FLUIDIC SYSTEMAspiration, mm Hg 75-585 Not specified Not specified Not specifiedIrrigation system Coaxial Central or outside Central or outside Central or outside

Fluid Saline Saline Saline Saline

Flow rate, cc/min 2-25, variable Not specified Not specified 0-150HANDPIECECONFIGURATIONS

Straight Yes Not specified 25 kHz 25 kHzAngled Yes Not specified Not specified Not specifiedStraight extended Yes 25 kHz Not specified Not specifiedAngled extended Yes 25 kHz Not specified Not specifiedOther Not specified Not specified Not specified Not specified

TIPType Straight and curved

aspiration and bone-shavingtips, titanium

Titanium alloy Titanium alloy Titanium alloy

Reusable/disposable Disposable Reusable Reusable ReusableSTERILIZATION EtO, steam, flash Autoclavable at 134°C Autoclavable at 134°C Autoclavable at 134°CFOOTSWITCH CONTROL Yes, wireless Not specified Not specified Not specified

Preset mode Yes Yes Yes Yes

Linear mode Yes No No No



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DISPLAYS Irrigation, aspiration,vibration, bar graphs 0-100%, ultrasound time, errorcodes

Ultrasound, frequency,active time

Ultrasound, frequency,active time

Ultrasound, frequency,irrigation, active time

CONTROLS Up/down ramp for irrigation,aspiration, vibration, linear,preset select, audiofeedback, alarm override,alarm volume

Ultrasound Ultrasound Ultrasound, irrigation

ERROR CODEMESSAGES

Clogged/damaged tip,handpiece malfunction,suction/footswitch/electronicsproblem

Handpiece malfunction,functional error



POWER REQUIREMENTSVAC 110/220/240 110-120/220-240 110-120/220-240 110-120/220-240Hz 50/60 50/60 50/60 50/60Amp 4/2 2/1 2/1 2/1

H x W x D, cm (in) 108 x 48 x 36 (40 x 19 x 14) 15 x 31 x 38.5 (5.9 x 12.2 x15.2)

15 x 31 x 38.5 (5.9 x 12.2 x15.2)

15 x 31 x 38.5 (5.9 x 12.2 x15.2)


70 (154) 13.5 (29.8) 13.5 (29.8) 13.5 (29.8)

Handpieces, g (oz) 226 (8) 147 (5.2) straight, 163 (5.8)long curved, 283 (10) liposhort, 287 (10.1) lipo long

147 (5.2) straight 147 (5.2) straight

PURCHASEINFORMATION


$100,000 Not specified Not specified Not specified

Warranty 1 year for console andhandpieces

1 year 1 year 1 year

Training Not specified Not specified Not specified Not specifiedDelivery time, ARO 4 weeks Not specified Not specified Not specifiedNumber sold 200 Not specified Not specified Not specified

Year first sold 2003 Not specified Not specified Not specifiedFiscal year July to June Not specified Not specified Not specified



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OTHER SPECIFICATIONS RF electrocautery capable;wireless technology;OsteoSculpt bone-shavingtips. Meets requirements ofUL 2601-1/IEC 601-1.

None specified. Includes trolley. Includes trolley.

UMDNS CODE(S) 15756 15756 15756 15756LAST UPDATED May 2008 May 2008 May 2008 May 2008Supplier Footnotes

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MODEL SOERING SOERING SOERING SOERINGSONOCA 190 SONOCA 300 SONOCA 400 SONOCA Lipo

WHERE MARKETED Worldwide Worldwide Worldwide, except USA WorldwideFDA CLEARANCE Yes Yes Not specified YesCE MARK (MDD) Yes Yes Yes YesSURGICAL INDICATIONS General, minimally invasive,

thoracic, neurology,gynecology

General, minimally invasive,thoracic, neurology,gynecology

General, minimally invasive,thoracic, neurology,gynecology, liposuction,wound treatment

Liposuction, woundtreatment

CONFIGURATION Tabletop Trolley based, generatorand pumps integrated

Trolley based, generatorand pumps integrated

Trolley based, generatorand pumps integrated

TRANSDUCERASSEMBLY





ULTRASONIC SYSTEMFrequency, kHz 20-80 20-80 20-80 20-80Maximum amplitude, µm 200 peak 200 peak 200 peak 200 peakOscillation system Electrostrictive PZT Electrostrictive PZT Electrostrictive PZT Electrostrictive PZT

FLUIDIC SYSTEMAspiration, mm Hg Not specified 0-0.9 bar 0-0.9 bar 0-0.9 bar

Irrigation system Central or outside Central or outside Central or outside Not specifiedFluid Saline Saline Saline Not specifiedFlow rate, cc/min Not specified 0-150 mL/min 0-250 0-250


Straight 25 kHz 25 kHz, 35 kHz 25 kHz, 35 kHz Not specifiedAngled 25 kHz 25 kHz, 35 kHz 25 kHz, 35 kHz Not specifiedStraight extended 25 kHz 25 kHz 25 kHz 25 kHzAngled extended 25 kHz 25 kHz, 35 kHz 25 kHz, 35 kHz 25 kHzOther 55 kHz, laparoscopic 55 kHz, laparoscopic 55 kHz, laparoscopic Not specified

TIPType Titanium alloy Titanium alloy Titanium alloy Titanium alloyReusable/disposable Reusable Reusable Reusable Reusable

STERILIZATION Autoclavable at 134°C Autoclavable at 134°C Autoclavable at 134°C Autoclavable at 134°CFOOTSWITCH CONTROL Not specified Not specified Not specified Not specified

Preset mode Yes Yes Yes Yes

Linear mode No No No No



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DISPLAYS Ultrasound, frequency,active time

Irrigation, aspiration,ultrasound, frequency,active time

Irrigation, aspiration,ultrasound, frequency,active time

Irrigation, aspiration,ultrasound, active time

CONTROLS Ultrasound Irrigation, aspiration,ultrasound

Irrigation, aspiration,ultrasound

Irrigation, aspiration,ultrasound

ERROR CODEMESSAGES





POWER REQUIREMENTSVAC 110-120/220-240 110-120/220-240 110-120/220-240 110-120/220-240Hz 50/60 50/60 50/60 50/60Amp 2/1 2/1 2/1 2/1

H x W x D, cm (in) 15 x 31 x 38.5 (5.9 x 12.2 x15.2)

15 x 43 x 56 (5.9 x 16.9 x22)

15 x 43 x 56 (5.9 x 16.9 x22)

15 x 43 x 56 (5.9 x 16.9 x22)


13.5 (29.8) 24 (52.9) 22 (48.5) 24 (52.9)

Handpieces, g (oz) 147 (5.2) straight/short

curved, 163 (5.8) longcurved, 281 (9.9)laparoscopic, 114 (4)microhandpiece

147 (5.2) straight/short





curved 163 (5.8) longcurved, 283 (10) lipo short,287 (10.1) lipo long

PURCHASEINFORMATION


Not specified Not specified Not specified Not specified

Warranty 1 year 1 year 1 year 1 yearTraining Not specified Not specified Not specified Not specifiedDelivery time, ARO Not specified Not specified Not specified Not specifiedNumber sold Not specified Not specified Not specified Not specified

Year first sold Not specified Not specified Not specified Not specifiedFiscal year Not specified Not specified Not specified Not specified



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OTHER SPECIFICATIONS 3 default workingfrequencies available.

3 default workingfrequencies available;includes trolley.

3 default workingfrequencies; includes trolley.

Includes trolley.

UMDNS CODE(S) 15756 15756 15756 15756LAST UPDATED May 2008 May 2008 May 2008 May 2008Supplier Footnotes

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MODEL SOUND SURGICAL SOUND SURGICAL SYNERGETICSVASER System(Suction/Irrigation Console)

VASER System (Ultrasonic Amplifier)

Omni Ultrasonic SurgicalSystem UST2001

WHERE MARKETED Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes YesCE MARK (MDD) Yes Yes YesSURGICAL INDICATIONS Soft-tissue fragmentation

and aspiration, soft-tissuedissection and coagulation,lipoplasty

Soft-tissue fragmentationand aspiration, soft-tissuedissection and coagulation,lipoplasty

Neurosurgery,gastrointestinal andaffiliated organ surgery,urologic, plastic andreconstructive, general,orthopedic, gynecologic,thoracic, laparoscopic,thoracoscopic, ophthalmic,oculoplastic,otorhinolaryngologic,otolaryngology, abdominal

CONFIGURATION Console Tabletop ConsoleTRANSDUCER

ASSEMBLY

NA Permanently housed in

handpiece

Permanently housed in

handpieceULTRASONIC SYSTEM

Frequency, kHz NA 23-55 handpiece dependent 25, 34Maximum amplitude, µm NA Handpiece dependent 365 (25 kHz), 210 (34 kHz)Oscillation system NA PZT Piezoelectric, Omni LT

technologyFLUIDIC SYSTEM

Aspiration, mm Hg 686 NA 0-500Irrigation system Not specified NA Coaxial

Fluid Not specified NA SalineFlow rate, cc/min 0-500 NA 3-40, variable


Straight Yes Yes 25 kHz, 320 µmAngled No No 25 kHz, 300 µm; 34 kHz,

210 µm; 25 kHz, 365 µm;

25 kHz, 320 µmStraight extended No No Not specifiedAngled extended No No Not specifiedOther Not specified Not specified Not specified

TIPType Stainless steel Titanium TitaniumReusable/disposable Reusable Reusable Sterile, disposable

STERILIZATION Steam, STERRAD, EtO Steam, STERRAD, EtO EtO, steam autoclavableFOOTSWITCH CONTROL Yes Yes Yes

Preset mode Yes Yes YesLinear mode No No No

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DISPLAYS Irrigation rate, infusedamount ±1 mL, aspirationlevel, irrigation pumpforward/reverse, poweron/off, footswitches on/off

Vibration mode (pulsed orcontinuous), vibrationamplitude (%), faultcondition indicator, timer

Irrigation, aspiration,ultrasound power, alarms

CONTROLS Irrigation rate, aspirationlevel, forward/reverse onpump, on/off footswitches

Vibration amplitude,vibration mode(pulsed/continuous), timerreset, speaker on/off, testswitch, footswitch on/off,power on/off

Irrigation, aspiration,ultrasound power

ERROR CODEMESSAGES

Not specified Vibration fault Frequency, overload,ultrasound

POWER REQUIREMENTSVAC 115/230 115/230 110/220Hz 50/60 50/60 50/60

Amp 6.3 3.1 3/2H x W x D, cm (in) 79 x 46 x 43 (31 x 18 x

16.9)10 x 40 x 36 (4 x 15.8 x14.2)

23.5 x 41 x 40 (9.2 x 16.1 x15.7)


43 (95) 14.5 (32) 20.4 (45)

Handpieces, g (oz) 43 (1.5) 241 (8.5) 82.2 (2.9)PURCHASEINFORMATION


Not specified Fee per procedure Not specified

Warranty 1 year 1 year 3 yearsTraining Off-site, manual Off-site, manual Included in purchase priceDelivery time, ARO 2 weeks 2 weeks Shipped same dayNumber sold Not specified Not specified Not specified

Year first sold 2001 2001 2001Fiscal year January to December January to December Not specified



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OTHER SPECIFICATIONS Precision fluid managementsystem; proprietarycannulae; patented suctionhandpiece minimizesclogging; low-noise suction.Meets requirements of EN60601-1 and 60601-1-2,ISO 10993 and 13485, UL2601-1.

Patented pulsed-energydelivery providesfragmentation with lessenergy and heat to thepatient; proprietary tipdesign reduces tip-endenergy concentration andincreases effective area offragmentationcircumferentially around tip.Meets requirements of EN60601-1 and 60601-1-2,ISO 10993 and 13485, UL2601-1.

Bone emulsificationtechnology standard;intraoperative tip changing;10 tip choices; preaspirationholes on tips; color-codeddisposables. Meetsrequirements of UL 2601-1,CSA 22.2 No. 601.1, andEMC UL 2601-1-2 testing,IEC 601-1 and 601-1-2.

UMDNS CODE(S) 15756 15756 15756LAST UPDATED May 2008 May 2008 May 2007

Supplier FootnotesModel Footnotes

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Chart B: Ultrasound Surgical Units


ETHICON MEDICAMAT U.S. SURGICAL

Ultrasound Surgical Units Harmonic Scalpel Morpho Sonic Endotron AutoSonix System

WHERE MARKETED Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes YesCE MARK (MDD) Not specified Yes YesSURGICAL INDICATIONS General, gynecology,

pediatrics, urology,laparoscopic thoracicsurgery, ENT

General, plastic surgery,lipoaspiration

Abdominal, thoracic,gynecologic, pediatric,open/laparoscopicprocedures for dissection,coagulation, andhemostasis of soft tissue

CONFIGURATION Tabletop Wheeled cart Console, tabletopTRANSDUCERASSEMBLY





ULTRASONIC SYSTEMFrequency, kHz 22-55.5 55.5 22-28 55.5Maximum amplitude, µm 400 60-100, depends on power

level and blade design220 steel, 378 Ti 110

Oscillation system Piezoelectric Piezoelectric Piezoelectric PiezoelectricBLADE CONFIGURATIONMaterial Titanium, titanium alloy Titanium alloy Titanium alloy cannula

configurationTitanium alloy

Style Dissecting hook, curvedblade, sharp curved blade,sharp hook, ball coagulator,coagulating shears, curvedcoagulating shears

Not specified 5 mm coagulating shears, 5mm hook, 5 mm ball

Reusable/disposable Both Reusable (70 hr) DisposableLaparoscopic/open Both Both Not specified Both

STERILIZATION EtO, steam, flash autoclave Autoclave 121°C, 136°C 2bars max

Steam, EtO, STERIS

DISPLAYS Power level (setting), mode,system status indicators(e.g., alarms)

Power level, standby mode,ready mode, vibrationstatus, other alarms

Power, irrigation Power setting, ultrasoundon electrical fault,mechanical fault

AUDIBLE INDICATORS Yes Power level, vibration

status, other alarms

Vibrations Power setting, electrical

fault, mechanical fault

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Chart B: Ultrasound Surgical Units


ETHICON MEDICAMAT U.S. SURGICAL

Ultrasound Surgical Units Harmonic Scalpel Morpho Sonic Endotron AutoSonix SystemCONTROLS Power level (footswitch

control), standby/readymodes, volume, displaycontrast

Ultrasound power, vacuum,peristaltic pump

Dual footpedal,ready/standby switch,control knob

ERROR CODEMESSAGES

Yes System error Flashing LED when novacuum

Electrical fault, mechanicalfault

POWER REQUIREMENTSVAC 100-240 110/220 110/220/240Hz 50/60 50/60 50/60Amp 2/1 Not specified 4/2

H x W x D, cm (in) 13 x 37 x 39 (5.3 x 14.5 x15.2)

102 x 35 x 34 (40.1 x 13.7 x13.3)

30.5 x 19.8 x 47 (12 x 7.8 x18.5)


7.4 (16.3) 13-28 (28.7-61.7) 8.9 (19.6)

Handpieces, g (oz) 170 (6) 500 (17.6) 125.7 (4.4)PURCHASEINFORMATION

List price, stdconfiguration

$20,902 GEN04, handpiece $30,800 complete unit;$22,000 tabletop

$19,898

Warranty 1 year 1 year 36 monthsDelivery time, ARO Not specified ≤3 months 2 weeksService contract $1,370/year Optional 12 or 24 months beyond

warrantyTraining Included in purchase price Yes Included in purchase price

Year first sold 1992 1997 1998Fiscal year January to December Not specified January to December

OTHER SPECIFICATIONS Optional cart andsterilization tray. CSA andTUV listed. Meets CISPR,11 EMI, UL 544 emission,

AAMI ES1, AAMI HF-18defibrillator-proof, IEC 601-1, IEC 801-2 electrostaticdischarge, IEC 801-3radiated EMF, IEC 801-4electrical transients/bursts,IEC 801-5 electrical surgeimmunity.

Allows liposuction withsimultaneous irrigation.

Meets requirements of ETL,IEC, and UL.

UMDNS CODE(S) 18049 18049 18049 18049LAST UPDATED March 2004 May 2008 May 2008Supplier Footnotes 1These recommendations

are the opinions of ECRIInstitute's technologyexperts. ECRI Instituteassumes no liability fordecisions made based onthis data.

Model FootnotesData Footnotes


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Documents

Aspirators Ultrasononic - Ultrasound Surgical Units.PDF