8/9/2019 Aspirators Ultrasononic - Ultrasound Surgical Units.PDF http://slidepdf.com/reader/full/aspirators-ultrasononic-ultrasound-surgical-unitspdf 1/23 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail [email protected]UMDNS Information This Product Comparison covers the following device terms and product codes as listed in ECRI Institute’s Universal Medical Device Nomenclature 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 W W W . D E Z M E D . C O M
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail [email protected]
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
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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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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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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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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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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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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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,
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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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)
WEIGHTUltrasonic system, kg(lb)
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
List price, standardconfiguration
$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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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
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
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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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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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
HANDPIECECONFIGURATIONS
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
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)
WEIGHTUltrasonic system, kg(lb)
43 (95) 14.5 (32) 20.4 (45)
Handpieces, g (oz) 43 (1.5) 241 (8.5) 82.2 (2.9)PURCHASEINFORMATION
List price, standardconfiguration
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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MODEL SOUND SURGICAL SOUND SURGICAL SYNERGETICSVASER System(Suction/Irrigation Console)
VASER System (Ultrasonic Amplifier)
Omni Ultrasonic SurgicalSystem UST2001
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
Data Footnotes
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