Ultrasound System - Frank's Hospital Workshop · 2020. 6. 17. · HDI 5000 Scanheads and Safety 4701-0027-04 2--1 Scanheads Thescanheadthat youselect isthemost important factorinimagequality

Copyright E 2000 by ATL Ultrasound All rights reserved Printed in USA

Scanheads and SafetyATL UltrasoundP.O. Box 3003

Bothell, WA 98041-3003USA

Ultrasound System

4701-0027-04 Rev A April 2000

Manufactured by ATL Ultrasound

22100 Bothell-Everett HighwayBothell, WA 98021-8431USA

Telephone (425) 487-7000 or (800) 426-2670Fax (425) 485-6080ITT International 4740016 SMS UIInternet www.atl.com

CAUTION

United States federal law restricts this device to sale byor on the order of a physician.

“Advanced 3DI”, “Advanced Technology Laboratories”, “ATL”, “CHROMA”, “Cineloop”, “Color Power Angio”, “ENTOS”, “HDI”,“High Q”, and “Power Harmonic” are registered trademarks of ATL Ultrasound.

“DVS”, “Flash Contrast”, “High Definition”, “Power Motion”, “SonoCT”, “Tissue Specific”, and “WebLink” are trademarks of ATLUltrasound.

Non-ATL Ultrasound product names may be trademarks or registered trademarks of their respective owners.

ATL Ultrasound products may be manufactured under or operate in accordance with one or more of the followingUnited States patents and corresponding patents in other countries: U.S. Patent Numbers 4,581,636; 4,607,642;4,543,960; 4,644,795; 4,887,306; 5,016,641; 5,123,415; 5,197,477; 5,255,682; 5,050,610; 5,226,422; 5,275,167;5,207,225; 5,287,753; 5,215,094; 5,381,795; 5,386,830; 5,402,793; 5,390,674; 5,438,994; 5,471,989; 5,482,045;5,476,097; 5,471,990; 5,456,257; 5,485,842; 5,482,047; 5,479,930; Re 35,148; 5,555,887; 5,617,863; 5,669,385;5,645,066; D369,307; 5,634,465; 5,603,323; 5,706,819; 5,715,823; 5,718,229; 5,720,291; 5,879,303, 5,951,478; Re36,564; 5,980,457; 5,961,462; 5,940,123; 5,908,389; 5,891,035; 5,860,924; 5,795,297; 5,846,200; 5,833,613. Otherpatent applications are pending in various countries.

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HDI 5000 Scanheads and Safety 4701-0027-04 1--1

Read This First

About Your Manual SetThis manual is part of a manual set. The manual set addresses the reader who is familiarwith ultrasound techniques. Sonography training and clinical procedures are not includedin the manual set. The manual set includes the following:

� G etti n g Started : I nt r oduces you t o basic syst em f eat ures and concept s. W hen youcomplete the procedures in this manual, you will know how to use these features andunderst and t he c oncept s of syst em operat ion.

� S can h ead s an d S af et y: Cont ains inf or m at ion about s af et y, s c anheads , biops yguides , t r ans es ophageal and lapar os c opic s c anheads , and ac ous t ic out put .

� Reference Manual: Cont ains inf or m at ion t hat s uppor t s and am plif ies t he pr oc edur esin Getting Started. It includes image management, maintenance, troubleshooting,specifications, references, and a glossary.

� Usi n g Di si n f ect an t s an d G el s: Cont ains inf or m at ion about c om pat ible gels and dis -infectants and disinfecting ATL products.

� Acoustic Output Tables: Cont ains inf or m at ion about m ec hanic al and t her m al indexprecision and accuracy, the acoustic output default tables, and the acoustic outputtables.

� Medical Ultrasound Safety: Cont ains inf or m at ion about bioeff ec t s and biophy s ic s ,pr udent us e, and im plem ent ing A LA RA ( as low as r eas onably ac hiev able) .

� Operating Notes: Contains information that clarifies certain system responses thatmight be misunderstood or cause user difficulty.

About Your Manual Set on Compact Disc (CD)A CD is inc luded in a poc k et on t he ins ide bac k c ov er of t he Getting Started m anual. T heCD contains the complete manual set, except for the Operating Notes. The instructions forus ing t he CD ar e on t he las t page of t he Getting Started m anual.

Please take the time to use the CD, complete the brief survey card included with themanual set, and mail the survey card to us.

Read This First

HDI 5000 Scanheads and Safety 4701-0027-041--2

Conventions Used in This ManualThese conventions are used in this manual:

� All procedures are numbered. You must complete steps in the sequence they are pre-sented to ensure a reliable result.

� Bulleted lists indicate general information about a particular function or procedure.They do not imply a sequential procedure.

� Control names appear in this manual like they appear on the system.

� Menu items or titles appearing on the display are shown in the manual like they appearon the display.

� The left side of the system is to your left as you stand in front of the system, facing thesystem.

� Scanheads and pencil probes both are referred to as scanheads, unless the distinc-tion is important to the meaning of the text.

� “Select” means to place the cursor over an item and press SELECT once.

� “Double-select” means to place the cursor over an item, and quickly press SELECTtwo times, like double-clicking with a computer mouse. Pressing SELECT too slowlyon double select will only highlight an item. Pressing it rapidly will initiate an action.

System ConventionsThese conventions are used in the system:

� The software that runs the system uses graphic display elements similar to thoseusedin many personal computers. References to these elements in the software or in them anual ar e def ined in t he glos s ar y in t he Ref er enc e M anual .

� On a menu, protocol, or other display, a highlight bar indicates that the item or namecontained within the boundaries of the highlight bar is in the process of being selected.Pressing the SELECT control or other related control actually selects the item,assigns a value to a system parameter, or initiates the action related to the selecteditem.

� On a menu, an underlined letter indicates that pressing the underlined letter on thesystem keyboard will have the same effect as selecting the menu item with the track-ball and the SELECT control.

� On the system keyboard, pressing the Superkey and another designated key (forexample, 2D Maps) allows you to quickly change a system parameter without usingthe menu on which the parameter appears.


� Pressing a key or control the first time initiates a mode change, function, or operation,or changes the value of a system parameter. Pressing the same key or control a sec-ond time resumes a previous mode or system parameter, cycles to the next setting, orends the function or operation. All MENU controls work this way, and it can be quickerto press the MENU control than to select Close, especially to exit a submenu.

� On a menu, protocol, or other display, text that is lighter in color than the other text onthe display indicates that the item or name contained within the boundaries is not avail-able for selection in that menu, protocol, or display.

� A or indicates an option or alternative for selection.

� A or indicates that an option or alternative has been selected.

� Selecting Close from a menu or display removes the menu or display from the screen.

� Selecting + or -- increases or decreases the value of the parameter.

� An ellipsis ... on a menu indicates that a submenu is available from the selection.

� To highlight a menu, protocol, or other display item, use the trackball to move the cur-sor to the particular item.

� To enter text into a text field, use the keyboard.

� The softkeys, located on the lower right of the control panel, assume functions basedon your control selections. For example, pressing VCR CTRL results in the softkeysassuming these VCR control functions: PLAY, PAUSE, STOP, FF (Fast Forward),and REWIND.

System Upgrades and Manual Set UpdatesATL Ultrasound is committed to innovation and continued improvement. Upgrades may beannounced that consist of hardware or software improvements. Updated manuals willaccompany those system upgrades.

Customer CommentsIf you have questions about the manual set, or you discover an error in the manual set,please call the ATL Customer Service at (800) 433-3246; or if you are outside the USA, callthe nearest ATL office, listed later in this section. You can also send electronic mail (e-mail)to ATL Technical Publications at the following address:

[email protected]

Read This First


ScanheadsThe scanhead that you select is the most important factor in image quality. Optimal imag-ing cannot be attained without the correct scanhead. The system is optimized for usebased on your scanhead selection.

Scanhead Surface Temperature LimitThe system limits patient contact temperature to 41 degrees Celsius, and acoustic outputvalues to their respective U.S. Food and Drug Administration limits. A power monitorprotection circuit protects against over-current conditions. If the power monitor protectioncircuit senses an over-current condition, then the drive current to the scanhead is shut offimmediately, preventing overheating of the scanhead surface and limiting acoustic output.Validation of the power monitor protection circuit is performed under normal system opera-tion.

Scanhead SelectionPressing t he S can h ead k ey dis play s t he S can h ead dis play ( F igur e 2 -- 1) . F r om t his dis -play, you select a scanhead, a clinical option (listed in the left column on the Scanheaddisplay), and a Tissue Specific preset (listed in the right column on the Scanhead display).Having selected these, the system runs through a set routine: it calibrates the scanhead;enables the scanhead for operation; and updates system status to reflect scanhead type,the clinical option, and the Tissue Specific preset you selected. On the Scanhead display,t he s c anheads ar e r epr es ent ed by s y m bols ( F igur e 2 -- 2) . Table 2 -- 1 pr ov ides s c anheadselection information.

Clinical Options and ApplicationsThe system is used for diagnostic ultrasound imaging or fluid-flow analysis of the humanbody in the following applications: fetal, abdominal, ophthalmic, intraoperative, pediatric,small organ, neonatal and adult cephalic, pediatric and adult cardiac, transesophageal,transrectal, transvaginal, peripheral vessel, and laparoscopic.

Scanheads


Tissue SpecificpresetsClinical options

Figure 2--1. Scanhead Display


-- Phased -- -- Linear --

-- Curved --

-- Pencil probe --

-- Intracavity --

Figure 2--2. Scanhead Symbols

Scanheads

Scanheads


Table 2--1. Scanhead Clinical Options

Scanhead Clinical Options

C4--2 Abdomen, Generic, Gyn/Fertility, OB

C5--2 Abdomen, General Imaging (CSI), Gyn/Fertility, OB

C7--4 Abdomen, Generic, Gyn/Fertility, OB, Pediatric

C8--4v Generic, Gyn/Fertility, OB

C8--5 Cerebrovascular, Generic, Musculoskeletal, Neurosurgery, OB, Pediat-ric, Pediatric Cardiology, Peripheral Vascular, Small Parts

C9--5 ICT Generic, Gyn/Fertility, OB, Prostate

CL10--5 Adult Cardiology, Cerebrovascular, Generic, Musculoskeletal, Neuro-surgery, Pediatric, Peripheral Vascular, Small Parts, Vascular Surgery

CT8--4 Abdominal Surgery, Generic

L7--4 Advanced Breast Imaging, Cerebrovascular, Generic, Musculoskeletal,Pediatric, Peripheral Vascular, Small Parts

L10--5 Advanced Breast Imaging, Cerebrovascular, Generic, Musculoskeletal,Pediatric, Peripheral Vascular, Small Parts

L12--538mm

Advanced Breast Imaging, Cerebrovascular, General Imaging Contrast,Generic, Musculoskeletal, Pediatric, Peripheral Vascular, Small Parts

L12--550mm

Advanced Breast Imaging, Cerebrovascular, General Imaging Contrast,Generic, Musculoskeletal, Pediatric, Peripheral Vascular, Small Parts

LAP L9--5 Abdominal Surgery, Generic

LI9--5 33mm Abdominal Surgery, Generic


Table 2--1. Scanhead Clinical Options (Continued)

Scanhead Clinical Options

P3--2 Abdomen; Adult, Pediatric, and CSI Cardiology; Gyn/Fertility; Generic;OB; Transcranial Doppler

P4--2 Abdomen; Adult, Pediatric, and CSI Cardiology; Gyn/Fertility; Generic;OB; Transcranial Doppler

P5--3 Abdomen; Adult, Pediatric, and CSI Cardiology; Generic; Gyn/Fertility;OB; Pediatric

P6--3 Abdomen, Generic, Gyn/Fertility, OB, Pediatric

P7--4 Adult and Pediatric Cardiology, Cerebrovascular, Generic, Neurosur-gery, OB, Pediatric

BPT9--5 Pediatric Transesophageal Cardiology, Generic

MPT7--4 Adult Transesophageal Cardiology, Generic

D2 TC Transcranial Doppler, Generic

CW 2 Adult and Pediatric Cardiology, Generic

CW 5 Cerebrovascular, Generic, Peripheral Vascular

CW 10 Generic, Peripheral Vascular

Scanheads

Scanheads


Doppler Maximum Measurable Velocity (MMV)The accuracy with which MMV can be measured is related to the accuracy of the parame-t er s s hown in Table 2 -- 2. T he Doppler m ax im um m eas ur able v eloc it ies wit h an ac c ur ac yof1% ar e s hown in Table 2 -- 3 and Table 2 -- 4. I f angle c or r ec t ion is us ed, t he M M V willincrease. For example, with an angle correction of 60�, the MMV will be twice that listed inTable 2 -- 3. S ee F igur e 2 -- 3 f or t he v ar iat ion of ac c ur ac y wit h Doppler angle.

Table 2--2. Doppler Accuracy

ParameterSystematicError Notes

Dopplerfrequency

¦ 0.4 % As a function of maximum frequency

Dopplerangle

¦ 1� See Table 2 -- 3 and Figure 2 -- 3

Velocity ¦ 0.4 % As a function of maximum velocity at 0� Doppler angle

Time ¦ 2.5 ms¦ 5 ms¦ 10 ms

Slow scroll rateMedium scroll rateFast scroll rate

Doppler angle (degrees)

% Accuracy variation

4

3

2

1

00 10 20 30 40 50 60

Figure 2--3. Accuracy Variation with Doppler Angle


Table 2--3. Doppler Maximum Measurable Velocities: Pulsed Wave

ScanheadDopplerFrequency (MHz)

Angle Correction(degrees)

MMV(meters/sec)

C4--2 2.5 0 7.0

C5--2 2.5 0 7.0

C7--4 4.0 0 4.4

C8--4v IVT 6.0 0 3.5

C8--5 6.0 0 3.5

C9--5 ICT 6.0 0 3.5

CT8--4 4.0 0 4.4

D2 TC 2.0 0 8.8

L7--4 4.0 0 4.4

L10--5 6.0 0 2.9

CL10--5 6.0 0 2.9

L12--5 38 mm 6.0 0 2.9

L12--5 50 mm 6.0 0 2.9

LAP L9--5 6.0 0 2.9

LI9--5 6.0 0 2.9

BPT9--5 6.0 0 2.9

MPT7--4 4.0 0 4.4

P3--2 2.0 0 8.8

P4--2 2.0 0 8.8

P5--3 3.0 0 5.8

P6--3 3.0 0 5.8

P7--4 4.0 0 4.4

Scanheads

Scanheads


Table 2--4. Doppler Maximum Measurable Velocities: Continuous Wave

ScanheadDopplerFrequency (MHz)

Angle Correction(degrees)

MMV(meters/sec)

D2 CW 2.0 0 19.3

D5 CW 5.0 0 7.7

D10 CW 10.0 0 3.9

BPT9--5 5.0 0 7.7

MPT7--4 4.0 0 9.6

P3--2 2.0 0 19.3

P4--2 2.0 0 19.3

P5--3 3.0 0 12.8

P7--4 4.0 0 9.6


Scanhead MaintenanceScanheads require proper care, cleaning, and handling. Reasonable care includesinspection, cleaning, and disinfection or sterilization, as necessary.

Inspect the scanhead cable, case, and lens before each use. Check for cracks or otherdamage that jeopardizes the integrity of the scanhead. Report any damage to your ATLUltrasound Customer Service Representative, and discontinue use of the scanhead.

Some ultrasound coupling gels, cleaning, disinfecting, and sterilizing solutionscan damage a scanhead. Before using a gel or solution on a scanhead, refer toUs ing Dis inf ec t ant s and G els , par t num ber 4700- 0249, - 16 or higher.

Acoustic ArtifactsThe transducer adds its own signature to the echo information in the form of beam widtheffects, axial resolution limitations, and frequency characteristics. The control choicesmade by the sonographer that affect amplification, signal processing, and echo signal dis-play can lead to significant differences in the displayed appearance of echo data. Follow-ing is a brief discussion of acoustic artifacts. An understanding of the physical basis for theproduction of signals displayed on ultrasound images is helpful in minimizing artifacts onimages and interpreting the results of studies.

An artifact is an echo displayed in a different position than its corresponding reflector in thebody. Artifacts can also be caused by intervening tissue properties. Artifacts can originatefrom external noise, reverberations, multi-path reflections, or misadjusted equipment.They can also come from the ultrasonic beam geometry and unusual changes in beamintensity. Artifacts and their manifestations are listed below, and following are some defini-tions of various artifacts.

� Added objects displayed as speckle, section thickness, reverberation, mirror image,comet tail, ring down.

� Missing objects due to poor resolution.

� Incorrect object brightness due to shadowing or enhancement.

� Incorrect object location due to refraction, multi-path reflections, side lobes, gratinglobes, speed error, or range ambiguity.

� Incorrect object size due to poor resolution, refraction, or speed error.

� Incorrect object shape due to poor resolution, refraction, or speed error.

Comet tail is a form of reverberation artifact produced when two or more strong reflectorsare close together and have a high propagation speed. In this case, sound does not traveldirectly to a reflector and back to the transducer; and a strong linear echo appears at thereflector and extends deeper than the reflector.

CAUTION

Scanheads

Scanheads


Enhancement is an increased relative amplitude of echoes caused by an interveningstructure of low attenuation.

Focal enhancement, also known as focal banding, is the increased intensity in the focalregion that appears as a brightening of the echoes on the display display.

Mirror imaging artifact is most commonly seen around the diaphragm; this artifact resultsfrom sound reflecting off another reflector and back.

Multi-path positioning and refraction artifacts describe the situation in which the paths toand from a reflector are different. The longer the sound takes traveling to or from a reflec-tor, the greater the axial error in reflector positioning (increased range). Refraction andmulti-path positioning errors are normally relatively small and contribute to general degra-dation of the image rather than to gross errors in object location.

A propagation speed error occurs when the assumed value for propagation speed by theultrasound system is incorrect. If the actual speed is greater than that assumed, the calcu-lated distance to a reflector is too small, and the reflector will be displayed too far from thetransducer. Speed error can cause a structure to be displayed with incorrect size andshape.

In ultrasound imaging, it is assumed that for each pulse produced, all reflections arereceived before the next pulse is sent out. If this is not thecase, rangeambiguity can result.The ultrasound system calculates the distance to a reflector from the echo arrival timeassuming that all echoes were generated by the last emitted pulse. The maximum depth tobe imaged unambiguously by the system determines its maximum pulse repetition fre-quency.

Reverberation is the continuing reception of a particular signal because of reverberationrather than reflection from a particular acoustic interface. This phenomenon is analogousto the effect created by mirrors positioned on opposite walls when an object, a head forinstance, is placed between the mirrors. The image of the head is reflected back and forthinfinitely between the two mirrors, creating the optical illusion of multiple heads. Rever-berations are easily identifiable, because they are equally spaced on the display display.

A condition of acoustic saturation occurs when received signals reach a system’s high-amplitude limit. At that point the system becomes unable to distinguish or display signalintensities. At the point of saturation, increased input will not increase output.

Scattering is the diffuse, low-amplitude sound waves that occur when acoustic energyreflects off tissue interfaces smaller than a wavelength. In diagnostic ultrasound, Dopplersignals come primarily from acoustic energy back-scattered from red blood cells.


Shadowing is the reduction in echo amplitude from reflectors that lie behind a stronglyreflecting or attenuating structure. This phenomenon occurs when scanning a lesion orstructure with an attenuation rate higher than that of the surrounding tissue. The lesioncauses a decrease in beam intensity, which results in decreased echo signals from thestructures beyond the lesion. Consequently, a dark cloud behind the lesion image formson the display. This cloud, or shadow, is useful as a diagnostic clue.

Side lobes (from single-element transducers) and grating lobes (from array scanheads)cause objects that are not directly in front of the transducer to be displayed incorrectly inlateral position.

Speckle appears as tissue texture close to the transducer but does not correspond to scat-terers in tissue. It is produced by ultrasound wave interference and results in generalimage degradation.

Speed of sound artifacts occur if the sound propagation path to a reflector is partiallythrough bone, and the speed of sound is greater than in the average soft tissue. Echo posi-tion registration artifacts will be produced. Reflectors appear closer to the transducer thantheir actual distance because of this greater speed of sound, resulting in a shorter echotransit time than for paths not containing bone.

When the detected Doppler frequency exceeds the Nyquist limit, aliasing occurs. It is char-acterized on the spectral display by the Doppler peaks going off the display, top or bottom,and then continuing on the other side of the baseline. On the Color display an immediatechange in color from one Nyquist limit to the other is seen.

Mirroring is the appearance of artifacts on a spectral display when there is improper sepa-ration of forward and reverse signal processing channels. Consequently, strong signalsfrom one channel mirror into the other.

Spectral broadening is a display phenomenon that occurs when the number of energy-bearing Fourier frequency components increases at any given point in time. As a conse-quence, the spectral display is broadened. Spectral broadening can indicate the disturbedflow caused by a lesion, and therefore it is important diagnostically. However, broadeningcan also result from interaction between flow and sample volume size, in which case it isan artifact.

Scanheads


Transesophageal ScanheadsThe MPT7-4 and the BPT9-5 transesophageal scanheads are both available for use withthe system. The MPT7-4 is a multi-plane transesophageal scanhead for adult cardiologyapplications, and the BPT9-5 is a bi-plane transesophageal scanhead for pediatric cardiol-ogy applications. The transesophageal scanheads can be used for 2D and M-mode imag-ing, pulsed-wave and continuous-wave Doppler, Color flow, and Power imaging.

Transesophageal scanhead applications include monitoring of cardiac ventricular functionby anesthesiologists of patients during cardiac and long non-cardiac surgery; pre- andpost-operative evaluation of cardiac valvular surgery; and general diagnostic and outpa-tient imaging of difficult-to-image patients. Potential future applications include coronaryartery examination and evaluation.

Transesophageal echocardiography in pediatric patients can be performed safely, butattention must be paid to possible airway obstruction or hemodynamic compromise. Foradditional information see the following references:

� Gilbert, T.B., Panico, F.G., McGill, W.A., Martin, G.R., Halley, D.G., and Sell, J.E.“Bronchial Obstruction by Transesophageal Echocardiography Probe in a PediatricCardiac Patient.” Anesth Analg, Vol. 74: 156--158, 1992.

� Muhiudeen, I., and Silverman, N. “Intraoperative Transesophageal Echocardiogra-phy Using High Resolution Imaging in Infants and Children with Congenital Heart Dis-ease.” ECHOCARDIOGRAPHY: A Jrnl. of CV Ultrasound & Allied Tech., Vol. 10, No.6: 599--608, November 1993.

� Muhiudeen, I.A., Silverman, N.H., and Anderson, R.H. “Transesophageal Transgas-tric Echocardiography in Infants and Children: The Subcostal View Equivalent.” Jour-nal of the American Society of Echocardiography, Vol. 8, No. 3: 231--244, May--June,1995.

� Stevenson, J.G., “Role of intraoperative transesophageal echocardiography duringrepair of congenital cardiac defects.” Acta Paediatric Suppl, 410: 23--33, 1995.

� Stevenson, J.G., and Sorensen, G.K. “Proper Probe Size for Pediatric Transesopha-geal Echocardiography.” THE AMERICAN JOURNAL OF CARDIOLOGY, Vol. 72:491--492, August 15, 1993.

Transesophageal Scanheads


Description

MPT7-4

The MPT7-4 consists of a multi-element ultrasound phased array mounted on an endo-scope. The transducer elements are electronically time- and phase-coordinated to gener-ate a steered and focused ultrasound beam. The scanhead is capable of imaging inmultiple scan planes. At 0-degree orientation, the acquired tomographic plane is equiva-lent to the transverse plane, and at approximately 90-degree orientation, longitudinalplane images can be obtained with the transducer array about 30 cm from the patient’steeth. The transducer array can be rotated up to 180 degrees, which provides a mirrorimage of the 0-degree orientation. Multiple tomographic image planes are continuouslyselected by rotating the transducer array without significant manipulation of the MPT7--4.Manipulation of the transducer array is accomplished by flexion of the endoscope tip withthe articulation controls.

BPT9-5

The BPT9-5 consists of two fixed phased array transducers mounted on an endoscope.The proximal transducer array is oriented inline or parallel with the endoscope, and thedistal transducer array is oriented perpendicular to the endoscope. Two switches on thecontrol module select between the two phased arrays. The distal switch selects the trans-verse array; the proximal switch selects the longitudinal array.

The BPT9-5 is capable of imaging in transverse or longitudinal scan planes. Off-axisimage planes are obtained by changing the orientation of the endoscope tip relative to thebody or heart. Manipulation of the two phased arrays by flexion of the endoscope tip isaccomplished with the articulation controls.


100.00 cm(39.37 inches)

Diameter of distal tip11.81 cm (0.71 inch)

10

For illustration purposes, cablelengths are not drawn to scale.

7


70.00 cm(27.55 inches)

BPT9-5MPT7-4

Figure 3--1. Critical Dimensions of the Transesophageal Scanheads




Scanhead Characteristics

T he m ax im um ac ous t ic power and int ens it y v alues for all scanheads, including the trans-es ophageal s c anheads , ar e lis t ed in A c ous t ic O ut put Tables , 4706- 0027- X X .

Ref er t o Table 3 -- 1 for a list of characteristics of the transesophageal scanheads.

Table 3--1. Scanhead Characteristics

Scanhead Characteristic MPT 7 -4 BPT9-5

Endoscope diameter 0.95 cm 0.83 cm

Transducer diameter 1.81 cm 1.01 cm

Endoscope length 100 cm 70 cm

Articulation ranges Left/right ±60_ ±60_g

Posterior 60_ 60_

Anterior 120_ 120_

ArticulationA r t ic ulat ion is c ont r olled by t wo k nobs on t he handle of t he s c anhead ( F igur e 3 -- 2 andF igur e 3 -- 3) . You c an m ov e t he s c anhead t ip t hr ough ar t ic ulat ing r anges of 60 degr ees t othe left through 60 degrees to the right and 60 degrees posteriorly through 120 degreesanteriorly.

For the MPT7-4, a scan plane position icon appears on the image display to the right of theimage. The scan plane position icon displays the current scan plane position relative to thes c anhead t ip ( F igur e 3 -- 4) . T he num ber t o t he lef t of t he M P T 7- 4 s c an plane pos it ion ic onis the value in degrees of offset of the scan plane. For the BPT9-5, the scan plane positionic on appear s t o t he r ight of t he im age dis play, and t he ac t iv e ar r ay is indic at ed as s hown inF igur e 3 -- 5.

T he br ak e but t ons on t he M P T 7- 4 s c anhead allow you to lock lock the articulation posi-tion. When the brake is on, a lock icon is displayed above the scan plane position icon( F igur e 3 -- 6) . O n t he B P T 9- 5, t he ar t ic ulat ion m ode s elec t ion lev er allows c ont inuous ordet ent m ov em ent of t he s c anhead t ip ( F igur e 3 -- 7) . W hen t he loc k ic on is dis play ed, t helever is in a locked position and the scanhead tip can only be moved in specific modes( Table 3 -- 2) .

Two articulation knobs are arranged one on the other. The smaller or upper knob controlsthe left/right articulation, and the larger or lower one controls the anterior/posterior articu-lat ion. T he r ot at ion of t he t wo k nobs is dir ec t ly r elat ed t o t he ar t ic ulat ion of t he s c anheadtip. A one-degree change in the knob corresponds to an approximate one-degree changein t he s c anhead t ip in t he s elec t ed dir ec t ion ( F igur e 3 -- 8) .


Do not manipulate a MPT7-4 transesophageal scanhead while inserted in a“locked” position. While it is physically possible, a hazard to the patient exists.

Scan Plane OrientationT he s c an plane or ient at ion of a t r ans es ophageal s c anhead is s hown in F igur e 3 -- 9 andF igur e 3 -- 10.

When you select the MPT7-4, the scan plane orientation is set to --5 degrees during initial-ization. Fully depressing the left and right scan plane rotation controls at the same time willalso reset the scan plane orientation to the --5 degrees position.

Image Orientation

Image presentation is defined by the location of the orientation marker. Top and bottomim age pr es ent at ions f or t he M P T 7- 4 ar e s hown in F igur e 3 -- 11. Top and bot t om im age pr e-s ent at ions f or t he B P T 9- 5 ar e s hown in F igur e 3 -- 12.

Scanheadconnector

Left/right articulationknob (small)Color: white

Anterior/posteriorarticulation knob(large)Color: gray

Top articulation knobbrake buttonColor: white

Bottom articulationknob brake button

Color: gray

Left scan plane rotation control

Right scan plane rotation control

Transducer array

Endoscope

Figure 3--2. MPT7-4 Features and Control Locations

WARNING




Scanhead connector


Anterior/posteriorarticulation knob(large)Color: gray

Longitudinal arraycontrol

Transverse array control

Transducer arrays

Articulation modeselection lever

Endoscope

Figure 3--3. BPT9-5 Features and Control Locations


Figure 3--4. MPT7--4 Scan Plane Position Icon




TransverseLongitudinal

Figure 3--5. BPT9--5 Scan Plane Position Icon


Press to release

Press to lock

Top brake button locks toparticulation knob

Bottom brake button locks bottomarticulation knob

Brake is enabled when the lock isshown on top of the scan planeposition icon.Scan plane

position icon

Figure 3--6. MPT7--4 Scan Plane Position Brake




Scan planeposition icon

Articulation mode selection lever(dashed lines show lever lock positions)

The lever is in a locked positionwhen the lock is shown at the topof the scan plane position icon.

1

3

2

Figure 3--7. BPT9--5 Articulation Mode Selection Lever

Table 3--2. BPT9-5 Articulation Mode Selection

Lever Positions (seeFigure 3 -- 7)

Anterior/PosteriorArticulation (lowerknob)

Left/Right Articula-tion (upper knob)

1 Locked Continuous Detent

2 Unlocked Continuous Continuous

3 Locked Detent Detent


RIGHTDEFLECTION(Upper Knob)

Scanhead orientation markers

Marker

Marker

Marker

Marker

0�DEFLECTION

LEFTDEFLECTION(Upper Knob)

ANTERIORDEFLECTION(Lower Knob)

POSTERIORDEFLECTION(Lower Knob)

CW = Clockwise CCW = Counterclockwise

60�

60�

60�

60�CCW

CW

CW

CCW

100100

100

Figure 3--8. Articulating Device Deflection




Right

0� transverse

45�short axis

Left

180� mirrored transverse

135�long axis

90� longitudinal

-- Scan plane positions for standard views of the heart --

90� longitudinal orientation0� transverse or 180� mirroredtransverse orientation

-- MPT7--4 --

-- BPT9--5 --

Figure 3--9. Scan Plane Orientation


CCW

Scan plane rotation controls

CCW rotation

Scanhead (tipof endoscope)

CW rotation

CW

Figure 3--10. MPT7--4 Scan Plane Orientation

Orientation marker in top position

Orientation marker in bottom position

Figure 3--11. MPT 7--4 Top/Bottom Image Presentation




Orientation marker in top position

Orientation marker in bottom position

Figure 3--12. Top/Bottom Image Presentation for the BPT9-5

Thermal Monitor

As a safety precaution, a thermal sensor is mounted on the scanhead tip adjacent to thetransducer array. This sensor is part of the system thermal monitoring system, which pro-vides continual thermal monitoring at the scanhead tip while the scanhead is selected.

Bioeffects have been documented at temperatures exceeding 41 degrees Celsius. Whenthe patient applied part temperature (PAPT) is greater than or equal to 41 degrees Celsius,the temperature will be displayed on the video monitor.

A warning is also displayed on the video monitor when the PAPT is 44 degrees Celsius:

Approaching thermal limit: currently 44 degrees C.

If this message appears, then reduce output power, lower PRF, or change imaging param-eters to reduce scanhead tip heating. The temperature will be updated as it changes.

The system will assume a circuit failure at a PAPT that is greater than or equal to 45degrees Celsius. This situation will result in an electronic disconnection of the transeso-phageal scanhead and the display of the following dialog on the video monitor:

Critical scanhead temperature.

Please reselect the scanhead.

Selecting OK on the dialog will display the Scanhead display. You can reselect the trans-esophageal scanhead from this display.


If you wish to resume scanning, use a lower power setting. If the scanheaddoes not enablewithin two minutes, or becomes disabled again, discontinue use and call an ATL CustomerService rupport Representative for service.

In extreme cases, a patient with a high fever may cause the system to disable the scan-head prematurely. If this occurs, attempt scanning at a lower output setting or changeimaging modes.

Operating Instructions

Inspection

Before using the scanhead, examine it for damage to the probe tip, casing, cable, and con-nector.

Do not use the scanhead if there are any signs of damage to the cable, connec-tors, casing, probe tip, or any other part. Notify ATL Customer SupportCustomerService or your local ATL representative in the event of observed or suspecteddamage.

Scanning the Patient

S A transesophageal scanhead is to be used only by askilled, trainedphysician.Before scanning, the physician should be thoroughly familiar with the articu-lating device (scan plane orientation, range of deflection, and position indica-tors).

S Prior to each exam, examine the scanhead for damage.

S Most scanheads cannot be sterilized. When sterility is required, use a sterilepr obe c ov er and gel. Ref er t o Us ing Dis inf ec t ant s and G els , 4700- 0249, - 16or higher

S Do not manipulate a transesophageal scanhead while inserted in a “locked”pos it ion ( r ef er t o “ A r t ic ulat ion” ) . W hile it is phy s ic ally pos s ible t o do s o, it isdifficult for the operator to gauge the amount of pressure applied to internalsurfaces, and a hazard to the patient exists.

S If you encounter resistance while manipulating the scanhead in the esopha-gus or stomach, stop the procedure immediately.

S Follow approved medical practices when anesthetizing and positioning thepatient, inserting the scanhead into the esophagus, and locating anatomicstructures. Ensure the patient’s airway remains open at all times.

WARNING

WARNINGS




Do not use a transesophageal scanhead without a bite guard. The scanhead canbe damaged if a bite guard is not used. Mechanical damage can be very costly torepair and is not covered by the warranty. Obtain bite guards through ATL Sup-plies and Accessories or your local ATL representative.

"""" To scan the patient with a transesophageal scanhead:

Images can be acquired starting at the transgastric position or at the base of the heart. Tohelp with patient comfort, efficient examination, and observance of the ALARA principle,minimize the number of scanhead excursions back and forth from the proximal esophagusto the gastric fundus.

1. Insert the bite guard into the patient’s mouth.

2. Introduce the endoscope with the array lens surface of the scanhead facing toward thepatient’s tongue. As the scanhead enters the esophagus, a 60-degree bend in the tipof the endoscope using the articulation knobs may aid insertion; straighten the tiponce the esophagus is entered.

3. Most images are acquired from points between 25 cm and 45 cm of depth with theM P T 7- 4 and 10 c m t o 15 c m wit h t he B P T 9- 5, m eas ur ed f r om t he pat ient ’s inc is ort eet h. M ar k ings on t he endos c ope ev er y 10 c m ( m eas ur ed f r om t he s c anhead t ip) ar eprovided for reference.

4. The scanhead orientation in the esophagus can be adjusted by turning the handleabout the scanhead longitudinal axis; the transducer array may be deflected laterally(right/left) and anteriorly/posteriorly by rotating the articulation knobs.

Maintenance

B ef or e c leaning t he s c anhead or us ing any dis inf ec t ant , r ef er t o Us ing Dis inf ec -t ant s and G els , 4700- 0249, - 16 or higher, f or inf or m at ion on c leaning and c om pat i-bility of scanhead and disinfectant.

After each examination, the transesophageal scanhead should be inspected for defectswith the transducer tip in the neutral position and all flexed positions. Possible defects aremetallic protrusions, perforations, abrasions, cracks, or dents in the insulation. Whenevera def ec t is s us pec t ed, t he s c anhead s hould not be us ed until necessary safety inspectionand repairs have been made by qualified personnel.

Visual inspection of a transesophageal scanhead does not always guarantee the integrityof t he ins ulat ion. I n addit ion t o v is ual ins pec t ion, a leakage current test should be per-formed by a qualified technician prior to every exam.

Do not store the transesophageal scanhead in its case until it has been cleaned and disin-fected.

CAUTION

CAUTION


Storage

Before you store or transport a transesophageal scanhead, ensure that you install theTEEtip guard over the tip of the scanhead. The TEE tip guard is a cylindrical foam protector thatfits over the distal tip of the scanhead to protect the transducer from damage(Figure 3--13).

To reorder the TEE tip guard, call ATL Supplies and Accessories or your local ATL repre-sentative.

To protect against disease transmission, do not reuse a TEE tip guard. Once youremove the TEE tip guard, dispose of it. Install a new TEE tip guard before storingor transporting the scanhead.

For long-term storage, ATL recommends that the endoscope be kept in a straight positionrather than in the flexed position in the carrying case. Commercial racks that protect theflexible shaft in the straight position in a clear plastic tube are available for long-term stor-age.

Proximal endof probe

Distal tip

TEE tip guard

TEE tip guardin place

Figure 3--13. TEE Tip Guard

WARNING



Laparoscopic ScanheadThe LAP L9--5 is a laparoscopic scanhead used in abdominal surgery. The scanhead canbe used for 2D and M-mode imaging, pulsed-wave Doppler, Color flow, and Power imag-ing.

The LAP L9--5 consists of a multi-element ultrasound linear array mounted on a laparo-scope. The transducer elements are electronically time- and phase-coordinated to gener-ate a focused ultrasound beam.

For illustration purposes, cableand laparoscope lengths arenot drawn to scale.


37.1 cm(14.6 inches)

Figure 4--1. Critical Dimensions of the LAP L9--5 Scanhead

Laparoscopic Scanhead

4--2 HDI 5000 Scanheads and Safety 4701-0027-04

ArticulationArticulation is controlled by rotating the scanhead and by turning the two knobs on the han-dle of the scanhead (Figure 4--2). You can move the scanhead tip through articulatingranges of 90 degrees to the left through 90 degrees to the right and 90 degrees posteriorlythrough 90 degrees anteriorly. The scan plane location is marked on the laparoscope witha dotted line and is controlled by rotating the scanhead (Figure 4--2).

Scanhead connector


Anterior/posteriorarticulationknob (large)Color: gray

Transducer array

Articulation modeselection lever

Dotted line marksthe scan plane

Figure 4--2. LAP L9--5 Features and Control Locations


An articulation mode selection lever on the scanhead allows you to lock the articulationposition (Figure 4--3).

Articulation mode selection lever(dashed lines show locked positions)

1

3

2

Figure 4--3. Mode Selection Lever

The two articulation knobs are arranged one on the other. The smaller or upper knob con-trols the left/right articulation and the larger or lower one controls the anterior/posteriorar t ic ulat ion ( F igur e 4 -- 4) .




RIGHTDEFLECTION(Upper Knob)

Scanhead orientation markers

Marker (at approximately70_ from 0_ deflection)

0�DEFLECTION

LEFTDEFLECTION(Upper Knob)

ANTERIORDEFLECTION(Lower Knob)

POSTERIORDEFLECTION(Lower Knob)

90�

90�

90�

90�

CW

CCW

CW

CCW

CW = Clockwise CCW = Counterclockwise

Marker (at approximately70_ from 0_ deflection)

Marker (at approximately 70_ from 0_ deflection)

Figure 4--4. Articulating Device Deflection


LAP L9--5 Operating Instructions

Inspection

Before using the scanhead, examine it for damage to the tip, casing, cable, and connector.Inspect the patient-applied surfaces of the scanhead for sharp edges or projections.

Do not use the scanhead if there are any signs of damage to the cable, connec-tors, casing, tip, or any other part. Notify ATL Customer Service or your local ATLrepresentative in the event of observed or suspected damage.

Installing the Probe Covers

Two covers are recommended for the laproscopic scanhead: one for the laparoscope, andone f or t he c ont r ol hous ing and c able. S ee t he “ P r obe Cov er s ” s ec t ion.

Scanning the Patient

S The scanhead is to be used only by a skilled, trained physician. Before scan-ning, the physician should be thoroughly familiar with the articulating devicesand range of deflection.

S Prior to each exam, examine the scanhead for damage.

S When sterility is required, use a sterile probe cover and sterile gel. Refer toUs ing Dis inf ec t ant s and G els , 4700- 0249, - 16 or higher.

S Do not manipulate a laparoscopic scanhead while inserted in a “locked” posi-tion. While it is physically possible to do so, it is difficult for the operator togauge the amount of pressure applied to internal surfaces, and a hazard tothe patient exists.

S If you encounter resistance while manipulating the scanhead, stop the proce-dure immediately.

S Follow approved medical practices when anesthetizing and positioning thepatient, inserting the scanhead into the abdomen, and locating anatomicstructures.

S To reduce the risk of damaging the scanhead, exercise caution when usingthe scanhead near sharp surgical instruments.

WARNING

WARNINGS




"""" To scan the patient with the LAP L9-5 scanhead:

1. I ns t all t he s t er ile pr obe c ov er on t he s c anhead, s ee t he “ P r obe Cov er s ” s ec t ion.

2. Install a 10-mm trocar into the patient’s abdomen.

3. Ensure the scanhead tip is straight.

4. Insert the scanhead through the trocar and into the abdomen.

5. The transducer array may be deflected laterally (right/left) and anteriorly/posteriorlyby rotating the articulation knobs.

6. Ensure the scanhead tip is straight before removal through the trocar.

LAP L9--5 Maintenance

B ef or e c leaning t he s c anhead or us ing any s t er ilant , r ef er t o Us ing Dis inf ec t ant sand G els , 4700- 0249, - 16 or higher, f or inf or m at ion on c leaning and c om pat ibilit yof scanhead and sterilant.

A f t er eac h ex am inat ion, t he s c anhead s hould be ins pec t ed f or def ec t s wit h t he t r ans duc ertip in the neutral position and all flexed positions. Possible defects are metallic protrusions,perforations, abrasions, cracks, or dents in the insulation. Whenever a defect is sus-pected, the scanhead should not be used until necessary safety inspection and repairshave been made by qualified personnel.

Storage

Do not store the scanhead in its case until it has been cleaned and sterilized.

For long-term storage, ATL recommends that the laparoscope be kept in a straight posi-tion rather than in the flexed position in the carrying case.

CAUTION


Biopsy GuidesBiopsy guides assist in the guidance of a biopsy tool. The system generates a guidelinethat represents the anticipated path of the biopsy tool. The echoes of the anatomical targetand the tool are displayed on the video display and assist in guiding the biopsy tool to thetarget.

Detailed information about installation and removal of biopsy guides is shipped with thebiops y guide or br ac k et . F or inf or m at ion about pr obe c ov er s , r ef er t o t he “ P r obe Cov er s ”section of this manual.

S Inspect all components. Ensure that the biopsy guide you are using is the cor-rect one for the scanhead, the system, and system software. Your CustomerService representative can verify this information for you.

S Alignment verification must be performed at the selected depth for theint ended pr oc edur e, pr ior t o a biops y pr oc edur e. S ee “ Ver if y ing t he B iops yG uide A lignm ent ” lat er in t his s ec t ion.

S Use only ATL-approved biopsy guides, brackets, supplies, components, andaccessories. Other brands may not properly fit ATL scanheads. Improperinstallation may result in patient discomfort.

S T he biops y guide m us t be ins t alled ov er a s t er ile pr obe c ov er. S ee t he “ P r obeCov er s ” s ec t ion of t his m anual.

S Most scanheads can only be disinfected; they cannot be sterilized. Only thepr obe c ov er pr ov ides t he s t er ile bar r ier.

S Biopsy guides should be high-level disinfected or sterilized after each use.Ref er t o Us ing Dis inf ec t ant s and G els , 4700- 0249, - 16 or higher.

Using the Biopsy Guideline Display"""" To select the biopsy guideline display for the C9-5 scanhead:

1. Select the C9-5 scanhead.

2. Press the 2D/MM MENU control to display the 2D/MMode menu.

3. S elec t Bi o p S el to display a Bi o p sy S el ect dis play ( F igur e 5 -- 1) .

4. Select the icon for the biopsy guide that you are using.

WARNINGS

Biopsy Guides


Biopsy Selectdisplay

Biopsy guideicon

Biopsy Sel

10652608

Biopsy Select

10651811

Figure 5--1. Selecting the Biopsy Guideline Display for the C9-5 Scanhead


"""" To turn on the biopsy guideline:

In zoom, the entire biopsy guideline may not be displayed. Use the SELECT con-trol and the trackball to adjust the location of the biopsy guideline and the depthcursor as necessary.

On the 2D/MMode menu, select Biopsy On. (The Biopsy Superkey can also be used todisplay the biopsy guideline.)

The biopsy guideline appears on the left side of the 2D image. The exact location of theguideline is a function of the system depth setting and the scanhead. The depth cursorappears along the path of the guideline, and the Guide to target distance measurementv alue is dis play ed beneat h t he 2D im age ( F igur e 5 -- 2) .

Orientationmarker

Depthcursor

Guideline

Figure 5--2. Biopsy Guideline Display (Bottom/Left Orientation)

"""" To move the biopsy depth cursor:

Rotate the trackball to move the depth cursor along the guideline.

The Guide to target distance measurement value changes to reflect the distancebetween the biopsy guide reference point origin and the depth cursor.

WARNINGWARNING

Biopsy Guides

Biopsy Guides


"""" To turn off the biopsy guideline:

On the 2D/MMode menu, select Biopsy Off. (The Biopsy Superkey may also be used toturn off the biopsy guideline.)

The biopsy guideline, the depth cursor, and the Guide to target distance measurementannotation are removed from the 2D display.

Verifying the Biopsy Guide Alignment

S Alignment verification is necessary prior to performing procedures with thebiopsy guide.

S Do not use the biopsy guide if the needle is not following the intended path.

S The needle used for this alignment verification must not be used for the actualprocedure. Always use a new, sterile needle for each biopsy procedure.

S To assist in an accurate projection of the needle, use a straight, new needlefor each alignment procedure.

Perform the alignment verification before the biopsy procedure. The alignment verifies thesystem, scanhead, and biopsy guide relationships.

The biopsy guide alignment verification is not performed for the L12--5 50 mm scan-head, instead refer to “Needle/Scan Plane Verification for the L12--5 50 mm.”

The following items are needed for the alignment verification:

� Scanhead.

� Biopsy guide or bracket (The bracket is not disposable. The type of bracket you usedepends upon the scanhead you are using. For the current part number, refer to theATL Supplies and Accessories catalog.)

� Refer to the ATL Supplies and Accessories catalog for the guide clip that fits yourscanhead adapter.

� Sterile biopsy guide kit (disposable).

� New, straight, biopsy needle.

� Beaker of water (or water bath).

"""" To perform an alignment verification:

1. Attach the bracket and procedure kit or the biopsy guide to the scanhead.

2. Connect the scanhead to the system, and select the appropriate Tissue Specific pre-set.

3. Select Biopsy On from the 2D/MMode menu.

WARNINGS

Note


4. Immerse the scanhead no more than 0.64 cm (0.25 inch) into the water bath, andinsert the needle into the biopsy guide (Figure 5--3).

5. Move the needle down into the water bath until its ultrasound image is visible on thevideo display.

Sterile probe cover

Displayed portion of the needle on thevideo monitor (equals Guide to targetdistance reading on the video monitordisplay minus the value listed inTable 5 -- 1 f or t he s c anhead)

11 1

Figure 5--3. Guide to Target Distance

IIf the needle enters from the unexpected side of the display, verify that the biopsyguide is correctly mounted and that the orientation of the scanhead is correct. Ifthe needle is still not following the expected path along the guideline, do not usethe biopsy guide. Contact your ATL customer service representative.

6. Verify that the needle, as seen on the video display, falls along the guideline along theentire depth of the guideline display. The biopsy guideline is only intended to providean indication of the expected path of the needle. Actual position must be verified byidentifying the echoes from the needle.

7. Remove the needle from the biopsy guide.

8. Move the depth cursor to the Guide to target distance for the scanhead as listed inTable 5 -- 1.

9. From the tip of the needle, measure a distance equal to the Guide to target distancevalue noted in step 8. Mark this point on the needle.

10. Immerse the scanhead no more than 0.64 cm (0.25 inch) into the water bath.

WARNING

Biopsy Guides

Biopsy Guides


11. Insert the needle into the biopsy guide until the mark on the needle aligns with the ori-gin on t he biops y guide ( F igur e 5 -- 4) . ( T he or igin is t he point at whic h t he needle ent er sthe biopsy guide or needle insert.)

12. Verify that the tip of the needle, as seen on the video display, falls within the rangelis t ed in Table 5 -- 1.

13. Confirm that the needle is visible along its expected path. If so, then the biopsy guide isproperly aligned.

Location of depth cursor(The needle would intersect

the depth cursor at this point.)

Depth cursor Guide to target dis-tance (13.7 cm)

Origin to image displaydistance is 11.7 cm

11.7 cm

Imagedisplay

Origin

Figure 5--4. Biopsy Guide Depth and Distance Relationships Example:C9--5 Scanhead and Biopsy Guide


Table 5--1. Guide to Target Distances and Ranges

Scanheads Distance and Range

C4--2 11.8 cm 0.50 cm

C5--2 11.8 cm 0.50 cm

C7--4 11.9 cm 0.50 cm

C8-5 6.7 cm 0.50 cm

C9--5 ICT 13.7 cm 0.50 cm

C8--4v IVT 19.8 cm 0.50 cm

L7--4 8.0 cm 0.50 cm

L10--5 8.0 cm 0.50 cm

L12--5 38 mm 6.4 cm 0.50 cm

L12--5 50 mm 6.4 cm 0.50 cm

P4--2 11.6 cm 0.50 cm

P5--3 8.8 cm 0.50 cm

P6--3 8.8 cm 0.50 cm

P7--4 9.4 cm 0.50 cm

Needle/Scan Plane Verification for the L12--5 50 mm

S Verifying that the needle appears in the scan plane is necessary prior to per-forming procedures with the L12--5 50 mm biopsy guide.

S Do not use the biopsy guide if the needle does not appear where youexpect.

S The needle used for this verification must not be used for the actual proce-dure. Always use a new, sterile needle for each biopsy procedure.

S To assist in an accurate projection of the needle, use a straight, newneedle for each verification procedure.

"""" To verify that the needle appears in the scan plane:

1. Prepare a water bath. A beaker filled with water is sufficient.

2. Install the probe cover and biopsy guide on the scanhead.

WARNINGS

Biopsy Guides

Biopsy Guides


3. Connect the scanhead to the system, and select the appropriate Tissue Specific pre-set.

4. Immerse the scanhead no more than 0.64 cm (0.25 inch) into the water bath, andinsert the needle into the biopsy guide.

5. Move the needle down into the water bath until the needle is visible in the scan planeon the display.

6. Confirm that the needle enters the display at the point you expect.

If the needle enters the display at a different position than youexpected, verify thatthe biopsy guide is correctly mounted and that the orientation of the scanhead iscorrect. If the needle is still not appearing where you expect, do not use the biopsyguide. Contact your ATL Customer Service representative.

Biopsy Procedure

S Alignment verification should be performed at the selected depth prior to thebiopsy procedure to ensure that the biopsy guide and the needle have beeninstalled properly.

S Thin needles can bend when entering tissue. Actual position must be verifiedby identifying the echoes from the needle.

S ATL does not recommend anatomical survey of the prostate with the biopsyguide attached.

S Use a straight, new needle for each procedure.

S The biopsy guideline is only intended to provide an indication of the expectedpath of the needle. Actual position must be verified by identifying the echoesfrom the needle.

S If the needle is not following the expectedpath, discontinue the procedureandcontact an ATL Customer Service representative.

"""" To perform a biopsy procedure:

1. Install the probe cover and the biopsy guide.

2. Set the system controls for the biopsy procedure.

3. Orient the scanhead to match the image presentation. Use the 2D scan plane orienta-tion marker.

4. Apply sterile, water-based lubricant to the probe cover, as needed.

5. Begin scanning the patient. Maneuver the scanhead so that the puncture target fallsalong the guideline displayed on the system monitor.

WARNING

WARNINGS


6. Perform the procedure by sliding the needle through the biopsy guide until the needle,as depicted by the echoes on the display, meets the target.

Biopsy Guide Maintenance

The procedure kit components are disposable and must not be reused.

Before cleaning, disinfecting, or sterilizing the biopsy guide or the transitionwedge, r ef er t o Us ing Dis inf ec t ant s and G els , AT L par t num ber 4700- 0249, - 16 orhigher.

WARNING

CAUTION

Biopsy Guides


Probe CoversProbe covers are recommended for clinical applications of an invasive nature, includingintraoperative, transrectal, intravaginal, transesophageal, and biopsy procedures. ATLrecommends the use of ATL-qualified probe covers. You can order probe covers from ATLSupplies and Accessories or your local ATL representative.

Some probe covers contain natural rubber latex and talc, which may cause aller-gic reactions in some individuals. Refer to the FDA Medical Alert, March 29, 1991,reprinted here.

FDA Medical Alert, March 29, 1991, Allergic Reactions to Latex-ContainingMedical Devices

Because of reports of severe allergic reactions tomedical devices containing latex (naturalrubber), the FDA is advising health care professionals to identify their latex sensitivepatients and be prepared to treat allergic reactions promptly. Patient reactions to latexhave ranged from contact urticaria to systemic anaphylaxis. Latex is a component of manymedical devices, including surgical and examination gloves, catheters, intubation tubes,anesthesia masks, and dental dams.

Reports to the FDA of allergic reactions to latex-containing medical devices haveincreased lately. One brand of latex cuffed enema tips was recently recalled after severalpatients died as a result of anaphylactoid reactions during barium enema procedures.More reports of latex sensitivity have also been found in the medical literature. Repeatedexposure to latex both in medical devices and in other consumer products may be part ofthe reason that the prevalence of latex sensitivity appears to be increasing. For example, ithas been reported that 6% to 7% of surgical personnel and 18% to 40% of spina bifidapatients are latex sensitive.

Proteins in the latex itself appear to be the primary source of the allergic reactions.Although it is not now known how much protein is likely to cause severe reactions, the FDAis working with manufacturers of latex-containing medical devices to make protein levelsin their products as low as possible.

FDA’s recommendations to health professionals in regard to this problem are as follows:

� When taking general histories of patients, include questions about latex sensitivity.For surgical and radiology patients, spina bifida patients and health care workers, thisrecommendation is especially important. Questions about itching, rash or wheezingafter wearing latex gloves or inflating a toy balloon may be useful. Patients with posi-tive histories should have their charts flagged.

WARNING

Probe Covers


� If latex sensitivity is suspected, consider using devices made with alternative materi-als, such as plastic. For example, a health professional could wear a non-latex gloveover the latex glove if the patient is sensitive. If both the health professional and thepatient are sensitive, a latex middle glove could be used. (Latex gloves labeled “Hypo-allergenic” may not always prevent adverse reactions.)

� Whenever latex-containing medical devices are used, especially when the latexcomes in contact with mucous membranes, be alert to the possibility of an allergicreaction.

� If an allergic reaction does occur and latex is suspected, advise the patient of a pos-sible latex sensitivity and consider an immunologic evaluation.

� Advise the patient to tell health professionals and emergency personnel about anyknown latex sensitivity before undergoing medical procedures. Consider advisingpatients with severe latex sensitivity to wear a medical identification bracelet.

The FDA is asking health professionals to report incidents of adverse reactions to latex orother materials used in medical devices. (See the October 1990 FDA Drug Bulletin.) Toreport an incident, call the FDA Problem Reporting Program, operated through the U.S.Pharmacopeia toll-free number: 800-638-6725. (In Maryland, call collect 301-881-0256.)

For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220,Rockville, MD 20857.

S If the sterile cover becomes compromised during surgical applications involv-ing a patient with Creutzfeldt-Jakob disease, the scanhead cannot be steri-lized or adequately disinfected by any method.

S Covers are disposable and must not be reused.

S In neurological applications, sterilized scanheads should be used with a pyro-gen-free probe cover.

S If an installed cover is cut or contaminated before use, a new cover must beinstalled.

Installing the CoverA cover is recommended for some ultrasound procedures, including intracavity, surgical,and biopsy procedures. The basic installation is described in the following procedure.

"""" To install the cover:

1. Wearing sterile gloves and without unrolling the cover, remove the cover from its pack-age.

2. Refer to the figure of the type of scanhead and cover you are using, and fill the coverwit h s t er ile ac ous t ic c oupling gel as s hown in t he appr opr iat e f igur e ( F igur e 6 -- 1 andF igur e 6 -- 2) .

WARNINGSWARNING


3. Insert the tip of the scanhead into the center of the rolled cover, and then unroll or pullthe cover to completely cover the scanhead, and if appropriate, the scanhead cable( F igur e 6 -- 3 t hr ough F igur e 6 -- 4) .

Maintain the sterility of the cover.

Gel

Sterile cover

Figure 6--1. Applying Gel to a Cover: Example

Sterile cover (in-side out)

Sterile gel

STE

RL

E

GE

L

Figure 6--2. Applying the Gel to a Cover: Example

4. Pull the tip of the sterile cover snugly over the scanhead ensuring there are no airbubbles in the acoustic gel on the face of the array.

WARNINGWARNING

Probe Covers

Probe Covers


5. Secure the cover to the scanhead, and if appropriate, the scanhead cable (Figure 6--3t hr ough F igur e 6 -- 5) . A s ec ur ing O - r ing is not r equir ed if a biops y guide is ins t alled ov erthe cover on the scanhead.

6. After the exam, dispose of the cover.

The tape strips are very strong. To remove them, carefully cut the tape with blunt--end scissors. Do not use scalpels or other sharp instruments that will damage thecable or scanhead.

C8--4v IVT

C9--5 ICT

O-ring

Cover

Figure 6--3. Intracavity Scanheads with Sterile Cover

Elastic band ortape strip placement(supplied with sterile

cover package)

Figure 6--4. Securing the Sterile Cover to a Scanhead: Example

CAUTION


Sterile cover(Pull the rest of the sterile cover to itsfull length, covering entire cable.)

Elastic bandor tape strip

Figure 6--5. Securing the Sterile Cover to the Scanhead Cable: Example

Installing Covers on the LAP L9--5Two covers are recommended for the laparoscopic scanhead: one for the laparoscope,and one for the control housing and cable.

S The cover is disposable and must not be reused.

S If the cover is cut before use, a new cover must be installed.

"""" To install the covers:

1. Wearing gloves, remove the first cover from its package.

2. Insert sterile acoustic coupling gel into the first cover using a sterile syringe. The firstcover can be filled with sterile saline solution instead of gel, if desired.

3. Insert the tip of the scanhead into the center of the cover, and pull the cover over thelaparoscope.

4. Pull the latex tip of the sterile cover snugly over the scanhead ensuring there are no airbubbles in the acoustic gel on the face of the array.

5. I f s aline s olut ion is us ed, s ec ur e t he c ov er us ing a s ut ur e s t r ing ( F igur e 6 -- 6) .

Maintain the sterility of the cover.

6. Position the second cover over the control housing and the cable, and secure it with anelas t ic band ( F igur e 6 -- 6) .

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Probe Covers

Probe Covers


First cover(with either saline solution or gel)

Elastic band

Suture string(if saline solu-tion is used)

S ec ond cover(secured with elastic band)

Figure 6--6. Laparoscopic Scanhead with Sterile Covers


SafetyPlease read this information before using an ATL ultrasound system. It applies to theultrasound system, scanheads, recording devices, and any optional equipment.

This device is intended for use by, or by the order of, and under the supervision of alicensed physician qualified to direct the use of the device.

In this manual set, a WARNING describes precautions necessary to prevent injury or lossof life.

In this manual set, a CAUTION describes precautions necessary to protect the equip-ment.

Electrical SafetyThis equipment has been certified by a recognized third-party testing agency as a Class Idevice with Type B non-isolated and Type BF and Type CF isolated patient-applied parts.For maximum safety observe these warnings:

S Shock hazards may exist if this system, including all externally mountedrecording and monitoring devices, is not properly grounded. Protectionagainst electrical shock is provided by grounding the chassis with a three-wirecable and plug. The system must be plugged into a grounded outlet. Thegrounding wire must not be removed or defeated.

S Do not remove the protective covers on the system; hazardous voltages arepresent inside. Cabinet panels must be in place while the system is in use.All internal adjustments and replacements must be made by a qualified ATLCustomer Service Representative.

S Do not operate this system in the presence of flammable gases or anesthet-ics. Explosion can result.

S To avoid risk of electrical shock hazards, always inspect the scanhead, pencilprobe, pulse transducer, and phonocardiography transducer before use:check the face, housing, and cable before use. Do not use it, if the face iscracked, chipped, or torn, the housing is damaged, or the cable is abraded.

S Inspect the Digital Video Streaming (DVS) hand controller before use. Do notuse it, if the housing or the cable is damaged.

S Inspect the Advanced 3DI Position Sensor and cable before use. Do not useit, if the position sensor or the cable is damaged.

S To avoid risk of electrical shock hazards, always disconnect the system fromthe wall outlet prior to cleaning the system.

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S All patient contact devices, such as scanheads, pencil probes, pulse trans-ducers, phonocardiography transducers, and ECG leads must be removedfrom patient contact prior to application of a high voltage defibrillation pulse.

S Connection of optional devices not supplied by ATL could result in electricalshock. When such optional devices are connected to your ultrasoundsystem,ensure that the total system earth leakage current does not exceed 300 μA.

S To avoid risk of electrical shock, do not use any scanhead or probe that hasbeen im m er s ed bey ond t he s pec if ied c leaning or dis inf ec t ion lev el. S ee Us ingDis inf ec t ant s and G els , par t num ber 4700- 0249, - 16 or higher.

S To avoid risks of electrical shock and fire hazards, inspect the system powercord and plug on a regular basis. Ensure that they are not damaged in anyway.

WARNINGS


S Prior to connecting the system to a power outlet, verify the voltage and fre-quency of the power outlet.

S Although your system has been manufactured in compliance with existingEMI/EMC requirements, use of this system in the presence of an electromag-netic field can cause momentary degradation of the ultrasound image. If thisoccurs often, ATL suggests a review of the environment in which the systemis being used, to identify possible sources of radiated emissions. These emis-sions could be from other electrical devices used within the same room or anadjacent room. Communication devices such as cellular phones and pagerscan cause these emissions. The existence of radio, TV, or microwave trans-mission equipment located nearby can cause emissions. In cases where EMIis causing disturbances, it may be necessary to relocate your system.

S Electrostatic discharge (ESD), commonly referred to as a static shock, is anaturally occurring phenomenon. ESD is most prevalent during conditions oflow humidity, which can be caused by heating or air conditioning. During lowhumidity conditions, electrical charges naturally build up on individuals andcan create static shocks. An ESD condition occurs when an individual withan electrical energy build-up comes in contact with objects such as metaldoorknobs, file cabinets, computer equipment, and even other individuals.The static shock or ESD is a discharge of the electrical energy build-up froma charged individual to a lesser or non-charged individual or object. The levelof electrical energy discharged from a system user or patient to theultrasoundsystem can be significant enough to cause damage to the system or scan-heads.

S The following precautions can help to reduce ESD: anti-static spray on car-pets; anti-static spray on linoleum; anti-static mats; or a ground wire connec-tion between the system and the patient table or bed. Additionally, anybuild-up of electrical energy can be dissipated by first touching the gray, rub-ber ESD pads provided on the system handles and wrist support of the sys-t em k eyboard, bef ore using t he syst em (F igure 7 -- 1).

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Wrist support

ESD pads

Figure 7--1. Locations of the Wrist Support and ESD Pads


Mechanical SafetyS Be aware of the casters, especially when moving the system. The system can

weigh 200 kg (440 pounds), depending upon configuration, and it could causeinjury to you or others if it rolls over feet or into shins. ATL recommends thatyou exercise caution when going up or down ramps.

S Position external hardcopy devices away from the system. Ensure that theyare secure. Do not stack them on the system.

S The monitor has been designed so that it can be easily removed from the sys-tem if needed. While using the system, or transporting the system with themonitor on the system, ensure that the two monitor latches are in the forward-horizontal, “locked” position.

Ensure that the cables for all patient-applied parts are secure. Use the cable man-agement system to ensure that scanhead cables are protected from damage.

System BrakesThe system has brakes for the front and the rear wheels. Push back with your foot on abrake to lock it, and pull forward to release it. Release the brakes when you move the sys-tem.

Moving the System

The front and back wheels are steerable on the system. If the system operates abnormallyafter you move it, contact ATL Ultrasound Customer Service immediately. The compo-nents are installed securely and can withstand considerable shock, but excessive shockcan cause a system failure.

Equipment ProtectionFollow these precautions to protect your system:

S Excessive bending or twisting of cables on patient-applied parts may causefailure or intermittent operation of the system.

S Improper cleaning or sterilization of a patient-applied part may cause perma-nent dam age. F or c leaning and dis inf ec t ion ins t r uc t ions , s ee Us ing Dis inf ec -t ant s and G els , par t num ber 4700- 0249, - 16 or higher.

S Do not submerge the cables of patient-applied parts in solution. The cablesare not liquid-tight beyond the applied part/cable or cable/connector inter-faces.

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CAUTIONS

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S Systems designed for connection to 230 or 240 Vac power have both 120 Vacand 240 Vac available for the installed hardcopy devices. The 120 Vac is pro-vided for the monitor, and the 240 Vac for the VCR and printer. Prior to con-necting an OEM power cord, verify that the voltage indicated on the powercord matches the voltage rating of the OEM device.

S Do not use solvents such as thinner or benzine, or abrasive cleaners on thesystem, scanhead or any hardcopy device.

S For optimal performance, your ATL ultrasound system should be connectedto a circuit dedicated solely for the HDI 5000 system.

S An isolation transformer protects the system from power surges. The isola-tion transformer continues to operate when the system is in standby. Ensurethat the circuit breaker is off, before unplugging the system from the wall out-let.

S In general, only the area of the scanhead acoustic window is watertight. Ex-cept where specified in specific scanhead cleaning instructions, do not im-merse the remainder of a scanhead in any liquid.

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SymbolsThe International Electrotechnical Commission (IEC) has established a set of symbols formedical electronic equipment which classify a connection or warn of potential hazards.The classifications and symbols are shown below.

Non-isolated patient connection. (Type B)

Isolated patient connection. (Type BF)

Isolated patient connection for applied parts in direct contact with major ves-sels. (Type CF)

/ On the circuit breaker, represents ON and OFF.

/ On the ON/STANDBY switch, represents ON and STANDBY.

This symbol identifies a safety note. Ensure you understand the function oft his c ont r ol bef or e us ing it . Ref er t o t he appr opr iat e s ec t ion in t he Ref er enc eM anual f or an ex planat ion of t he c ont r ol.

Identifies equipotential ground.

IPX1 Indicates that this device is protected against dripping water. This degree ofprotection can apply to scanheads and footswitches.

IPX7 Indicates that this device is protected against the effects of immersion. Thisdegree of protection can apply to scanheads.

The following symbols are also used on the system:

Connection for a pencil probe.

Connection for a scanhead.

Connection for ECG.

A Connection for pulse transducer.

B Connection for phono transducer.

Connection for footswitch.

Monitor brightness control.

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Monitor contrast control.

Color background control.

Lightbar control.

Microphone.

Non-interlaced RGB video with separate composite sync.

Interlaced RGB video with separate composite sync.

S video NTSC/PAL video output and input.

Composite NTSC/PAL video output and input.

B&W VID Composite monochrome video.

Serial and parallel printer connection. Parallel printer not supported.

Serial output connection.

Ethernet connection.

Left and right audio input.

Left and right audio output.

DVS hand-controller connection.

Lock.

Unlock.

The following symbols are used inside the system:

Identifies high voltage components.

Ground.


Biological SafetyThis section contains information about biological safety and a discussion of the prudentuse of the system.

A list of precautions related to biological safety follows; observe these precautions whenusing t he syst em. F or more inf ormat ion ref er t o 4700-0263-01, M edic al Ult r as ound S af et y.

S Do not use the system if an error message appears on the video display indi-cating that a hazardous condition exists. Note the error code, turn off power tothe system, and call your ATL Customer Service Representative.

S Do not use a system that exhibits erratic or inconsistent updating. Disconti-nuities in the scanning sequence are indicative of a hardware failure that mustbe corrected before use.

S Perform ultrasound procedures prudently. Use the ALARA (as low as reason-ably achievable) principle.

S Use only acoustic standoffs that have been approved for use by ATL.

S Ver if y t he alignm ent of t he biops y guide bef or e us e. S ee t he “ B iops y G uides ”section of this manual.

S Verify the condition of the biopsy needle before use. Do not use a bent biopsyneedle.

S Biopsy guide probe covers may contain natural rubber latex. These coversmay cause allergic reactions in some individuals. Refer to the FDA MedicalA ler t on Lat ex P r oduc t s , dat ed M ar c h 29, 1991, in t he “ P r obe Cov er s ” s ec t ionof this manual.

S For transcranial or cephalic use: when imaging or conducting pulsed Dopplerand color flow studies, this device is only intended for use in adults with intactskulls through the temporal and suboccipital windows.

S This device is not intended for use through the orbital window, burrholes, cra-niotomies, or neonatal fontanelles.

S Avoid scanning the posterior orbit of the eye. For transcranial or cephalic use:when scanning in the posterior region of the orbits, please be advised that thisdevice exceeds the FDA acoustic power and intensity limits for ophthalmicscanning.

ALARA Education Program

The guiding principle for the use of diagnostic ultrasound is defined by the “as low as rea-sonably achievable” (ALARA) principle. The decision as to what is reasonable has beenleft to the judgement and insight of qualified personnel. No set of rules can be formulatedthat would be sufficiently complete to dictate the correct response to every circumstance.

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By keeping ultrasound exposure as low as possible, while obtaining diagnostic images,users can minimize ultrasonic bioeffects.

Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonogra-pher’s responsibility to control total energy transmitted into the patient. The sonographermust reconcile exposure time with diagnostic image quality. To ensure diagnostic imagequality and limit exposure time, an ultrasound system provides controls that can be manip-ulated during the exam to optimize the results of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in diagnosticultrasound not only in the technology but in the applications of that technology, haveresulted in the need for more and better information to guide the user. The output displayindices are designed to provide that important information.

There are a number of variables which affect the way in which the output display indicescan be used to implement the ALARA principle. These variables include indice values,body size, location of the bone relative to the focal point, attenuation in the body, and ultra-sound exposure time. Exposure time is an especially useful variable, because it is con-trolled by the user. The ability to limit the index values over time supports the ALARAprinciple.

Applying ALARA

The system imaging mode used depends upon the information needed. 2D and M-Modeimaging provide anatomical information, while Doppler, Power, and Color imaging provideinformation about blood flow. A scanned mode, like 2D, Power, or Color, disperses or scat-ters the ultrasonic energy over an area, while an unscanned mode, like M-Mode or Dop-pler, concentrates ultrasonic energy. Understanding the nature of the imaging mode beingused allows the sonographer to apply the ALARA principle with informed judgement. Addi-tionally, the scanhead frequency, system setup values, scanning techniques, and opera-tor experience allow the sonographer to meet the definition of the ALARA principle.

The decision as to the amount of acoustic output is, in the final analysis, up to the systemoperator. This decision must be based on the following factors: type of patient, type ofexam, patient history, ease or difficulty of obtaining diagnostically useful information, andthe potential localized heating of the patient due to scanhead surface temperatures. Pru-dent use of the system occurs when patient exposure is limited to the lowest index readingfor the shortest amount of time necessary to achieve acceptable diagnostic results.

Although a high index reading does not mean that a bioeffect is actually occurring, a highindex reading should be taken seriously. Every effort should be made to reduce the pos-sible effects of a high index reading, limiting exposure time is an effective way to accom-plish this goal.


There are several system controls that the operator can use to adjust the image qualityand limit the acoustic intensity. These controls are related to the techniques that an opera-tor might use to implement ALARA. These controls can be divided into three categories:direct, indirect, and receiver controls.

Direct Controls

Application selection and the output intensity control directly affect acoustic intensity.Application selection refers to your selection of a clinical option and a Tissue Specific pre-set. There are different ranges of allowable intensity or output based on your selection.Selecting the correct range of acoustic intensity for the application is one of the first thingsthat occurs in any exam. For example, peripheral vascular intensity levels are not recom-mended for fetal exams. Some systems automatically select the proper range for a partic-ular application, while others require manual selection. Ultimately, the user has theresponsibility for proper clinical use. The ATL system provides both automatic or defaultand manual or user-selectable settings.

Output has direct impact on acoustic intensity. Once the application has been established,the output control can be used to increase or decrease the intensity output. The outputcontrol allows you to select intensity levels less than the established maximum. Prudentuse dictates that you select the lowest output intensity that is consistent with good imagequality.

Indirect Controls

The indirect controls are those that have an indirect effect on acoustic intensity. Thesecontrols affect imaging mode, pulse repetition frequency, focus depth, pulse length, andscanhead selection.

The choice of imaging mode determines the nature of the ultrasound beam. 2D is a scan-ning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam con-centrates energy in a single location. A moving or scanned ultrasound beam disperses theenergy over an area and the beam is concentrated on the same area for a fraction of thetime as that of an unscanned mode.

Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy overa specific period of time. The higher the pulse repetition frequency, the more pulses ofenergy in a period of time. Several controls affect pulse repetition frequency: focal depth,display depth, sample volume depth, color sensitivity, number of focal zones, and sectorwidth controls.

Different exams require different focal depths. Setting the focus at the proper depthimproves the resolution of the structure of interest. Changing the focus can affect theacoustic output.

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Pulse length is the time during which the ultrasonic burst is turnedon. The longer thepulse,the greater the time-average intensity value. The greater the time-average intensity, thegreater the likelihood of temperature increase and cavitation. Increasing the Doppler sam-ple volume increases the pulse length.

Scanhead selection indirectly affects intensity. Tissue attenuation changes with fre-quency. The higher the scanhead operating frequency, the greater the attenuation of theultrasonic energy. To scan deeper at the same output intensity, a lower scanhead fre-quency is required. Using more gain and output beyond a point, without correspondingincreases in image quality, can mean that a lower frequency scanhead is needed.

Receiver Controls

Receiver controls are used by the operator to improve image quality. These controls haveno effect on output. Receiver controls only affect how the ultrasound echo is received.These controls include gain, TGC, dynamic range, and image processing. The importantthing to remember, relative to output, is that receiver controls should be optimized beforeoutput is increased. For example: before increasing output, optimize gain to improveimage quality.

An Example of Applying ALARA

An ultrasound scan of a patient’s liver begins with selecting the appropriate scanhead fre-quency. After selecting the scanhead, clinical option, and Tissue Specific preset, whichare based on patient anatomy, adjustments to output power should be made to ensure thatthe lowest possible setting is used to acquire an image. After the image is acquired, adjust-ing the focus of the scanhead, and then increasing the receiver gain to produce a uniformrepresentation of the tissue follows. If an adequate image can be obtained with theincrease in gain, then a decrease in output should be made. Only after making theseadjustments should you increase output to the next level.

Having acquired the 2D display of the liver, Color can beused to localize blood flow. As withthe 2D image display, gain and image processing controls must be optimized beforeincreasing output.

Having localized the blood flow, use the Doppler controls to position the sample volumeover the vessel. Before increasing output, adjust velocity range or scale and Doppler gainto obtain an optimal Doppler trace. Only if maximum Doppler gain does not create anacceptable image do you increase output.

In summary: select the correct transducer frequency and application for the job; start witha low output level; optimize the image using focus, receiver gain, and other imaging con-trols; if the image is not diagnostically useful at this point, then increase output.


Additional Considerations

Ensure that scanning time is kept to a minimum, and ensure that only medically requiredscanning is performed. Never compromise quality by rushing through an exam. A poorexam may require a follow-up, which ultimately increases exposure time. Diagnostic ultra-sound is an important tool in medicine, and, like any tool, it should be used efficiently andeffectively.

Output Display

The system output display comprises two basic indices: a mechanical index (MI) and a thermalindex. The thermal index further consists of three indices: soft tissue (TIs), cranial bone(TIc), and bone (TIb). One of these three thermal indices will be displayed at all times.Which one depends upon the system preset or user choice, depending upon the applica-tion at hand.

The MI is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1.

The TI consists of the three indices, and only one of these is displayed at any one time.Each scanhead application has a default selection that is appropriate for that combination.The TIb, TIc, or TIs is continuously displayed over the range of 0.0 to 6.0 in increments of0.1.

The application-specific nature of the default setting is also an important factor of indexbehavior. A default setting is a system control state which is preset by the manufacturer orthe operator. The system has default index settings for the scanhead application. Thedefault settings are invoked automatically by the ultrasound system when power is turnedon, new patient data is entered into the system data base, or a change in application takesplace.

F igure 7 -- 2 illust rat es t he implement at ion of t he out put display in t he syst em.

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Figure 7--2. On-Screen TI and MI

The decision to display one or the other of the three thermal indices should bebased on thefollowing criteria:

� Appropriate index for the application: TIs is used for imaging soft tissue; TIc for trans-cranial; and TIb for a focus at or near bone.

� Mitigating factors that might create artificially high or low thermal index readings: loca-tion of fluid or bone, or blood flow. For example, is there a highly attenuating tissuepath so that the actual potential for local zone heating is less than the thermal indexdisplays.

� Scanned modes versus unscanned modes of operation affect the thermal index. Forscanned modes, heating tends to be near the surface; for unscanned modes, thepotential for heating tends to be deeper in the focal zone.

� Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indicesare kept to a minimum and that exposure time is limited without compromising diag-nostic sensitivity.


Mechanical Index Display

Mechanical bioeffects are threshold phenomena that occur when a certain level of outputis exceeded. The threshold level varies, however, with the type of tissue. The potential formechanical bioeffects varies with peak pressure and ultrasound frequency. The mechani-cal index accounts for these two factors. The higher the mechanical index value, thegreater the likelihood of mechanical bioeffects occurring. There is no specific mechanicalindex value at which a mechanical effect actually occurs. The mechanical index should beused as a guide for implementing the ALARA principle.

Thermal Index Displays

The TI informs the user about the conditions that exist that might lead to an increase intemperature at the surface of the body, within the body tissue, or at the point of focus of theultrasound beam on bone. That is, the TI informs the user of the potential for temperaturerise in body tissue. The TI is an estimate of temperature increase in body tissue with spe-cific properties. The actual amount of any temperature rise is influenced by such factors astissue type, vascularity, mode of operation, and others. The TI should be used as a guidefor implementing the ALARA principle.

The soft tissue TI (TIs) informs the user about the potential for heating within soft homoge-neous tissue.

The cranial bone TI (TIc) informs the user about the potential heating of bone at or near thesurface, for example, cranial bone.

The bone TI (TIb) informs the user about potential heating at or near the focus after theultrasound beam has passed through soft tissue or fluid, for example, at or near second orthird trimester fetal bone.

Mechanical and Thermal Indices Precision and Accuracy

The displayed values should be interpreted as relative information to help the systemoperator achieve the ALARA principle through prudent use of the system. The valuesshould not be interpreted as actual physical values in interrogated tissue or organs. Theinitial data that is used to support the output display is derived from laboratory measure-ments based on the AIUM measurement standard. The measurements are then put intoalgorithms for calculating the displayed output values.

Many of the assumptions used in the process of measurement and calculation are conser-vative in nature. Over-estimation of actual in situ intensity exposure, for thevast majority oftissue paths, is built into the measurement and calculation process; for example:

� The measured water tank values are derated using a conservative, industry standardattenuation coefficient of 0.3 dB/cm--MHz.

� Conservative values for tissue characteristics were selected for use in the TI models.Conservative values for tissue or bone absorption rates, blood perfusion rates, bloodheat capacity, and tissue thermal conductivity were selected.

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� Steady state temperature rise is assumed in the industry standard TI models, and theassumption is made that the ultrasound scanhead is held steady in one position longenough for steady state to be reached.

A number of factors are considered when estimating the accuracy of the displayed values;primary among them are hardware variations, estimation algorithm accuracy, and mea-surement variability. Variability among scanheads and systems is a significant factor.Scanhead variability is a product of, among others: the variability in piezoelectric crystalefficiencies, process-related impedance differences, and sensitive lens focusing parame-ter variations. Differences in system pulser voltage control and efficiencies is a contributorto variability, though in general, system variability tends to be smaller than scanhead vari-ability. There are inherent uncertainties in the algorithms used to estimate acoustic outputvalues over the very large range of possible system operating conditions and pulser volt-ages. Inaccuracies in laboratory measurements are related to, among others, differencesin hydrophone calibration and performance; positioning, alignment, and digitization toler-ances; and variability among test operators.

The conservative assumptions of the output estimation algorithms of linear propagation,at all depths, through a 0.3 dB/cm--MHz attenuative medium is not considered in the accu-racy estimate for the display. Neither linear propagation nor uniform attenuation at the 0.3dB/cm--MHz rate occur in water tank measurements or in most tissue paths in the body. Inthe body, different tissues and organs have dissimilar attenuation characteristics. In water,there is almost no attenuation. In the body, and in particular in water tank measurements,non-linear propagation and saturation losses occur as pulser voltages increase.

Therefore, the display accuracy estimates are based on the variability range of scanheadsand systems, inherent acoustic output modeling errors, and measurement variability. Dis-play accuracy estimates are not based on errors in, or caused by, measuring according tothe AIUM measurement standards or the effects of non-linear loss on the measured val-ues.

Thermal Index Help

The system provides an on-screen help feature. Press TI Help to access this feature.Pressing TI Help displays a summary of the information contained in this section.

You can select either TIs or TIb using the TIs/TIb selection on the 2D/MMode menu or bypressing the Superkey and the TI key on the system keyboard. TIc is displayed when youselect a transcranial application.


Control Effects

Controls Affecting the Indices

As various system controls are adjusted, the TI and MI values may change. This will bemost apparent as the OUTPUT control is adjusted; however, other system controls willaffect the on-screen output values. The following information supplements the TI Helpfunction.

OUTPUT

OUTPUT controls the system acoustic output. Two real-time output values are on thescreen: a thermal index and a mechanical index. They change as the system responds toOUTPUT control adjustments.

In combined modes, such as simultaneous Color, 2D and pulsed Doppler, the individualmodes each add to the total thermal index. One mode will be the dominant contributor tothis total. The displayed MI will be from the mode with the largest peak pressure.

2D Controls

Sector Angle

Narrowing the sector angle may increase frame rate. This action will increase the thermalindex. Pulser voltage may be automatically adjusted down with software controls to keepthe thermal index below the system maximums. A decrease in pulser voltage will decreaseMI.

ZOOM and HD ZOOM

Increasing the zoom magnification may increase frame rate. This action will increase thethermal index. The number of focal zones may also increase automatically to improve res-olution. This action may change MI since the peak intensity can occur at a different depth.

Frame Rate

A lower frame rate will decrease the thermal index. Pulser voltage may be automaticallyincreased. An increase in pulser voltage will increase MI.

ZONES

More focal zones may change both the thermal index and MI by changing frame rate orfocal depth automatically. Lower frame rates decrease the thermal index. MI displayed willcorrespond to the zone with the largest peak intensity.

FOCUS

Changing the focal depth will change MI. Generally, higher MI values will occur when thefocal depth is near the natural focus of the transducer.

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Color and Power Controls

Color Sensitivity

Increasing the color sensitivity may increase the thermal index. More time is spent scan-ning the color image. Color pulses are the dominant pulse type in this mode.

Color Sector Width

Narrower color sector width will increase color frame rate and the thermal index willincrease. The system may automatically decrease pulser voltage to stay below the sys-tem maximum. A decrease in pulser voltage will decrease the MI. If pulsed Doppler is alsoenabled then pulsed Doppler will remain the dominant mode and the thermal index changewill be small.

Color Sector Depth

Deeper color sector depth may automatically decrease color frame rate or select a newcolor focal zone or color pulse length. the thermal index will change due to the combinationof these effects. Generally, the thermal index will decrease with increased color sectordepth. MI will correspond to the peak intensity of the dominant pulse type which is a colorpulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain thedominant mode and the thermal index change will be small.

SCALE

Using the SCALE control to increase the color velocity range may increase the thermalindex. The system may automatically adjust pulser voltage to stay below the system maxi-mums. A decrease in pulser voltage will also decrease MI.

SEC WIDTH

A narrower 2D sector width in Color imaging will increase color frame rate. The thermalindex will increase. MI will not change. If pulsed Doppler is also enabled, then pulsed Dop-pler will remain the dominant mode and the thermal index change will be small.

M-Mode and Doppler Controls

Sweep Speed

M-mode and Doppler sweep speed adjustments will not affect the thermal indices or MI.

Simultaneous and Update Methods

Use of combination modes affects both the thermal index and MI through the combinationof pulse types. During simultaneous mode, the thermal index is additive. During auto-up-date and duplex, the thermal index will display the dominant pulse type. The displayed MIwill be from the mode with the largest peak pressure.


Sample Volume Size

An increase in the Doppler sample volume size will increase the thermal index. MI is notaffected. The system may decrease pulser voltage to maintain output below the systemmaximum. This decrease in pulser voltage would decrease MI.

Sample Volume Depth

When Doppler sample volume depth is increased the Doppler PRF may automaticallydecrease. A decrease in PRF will decrease the thermal index. The system may also auto-matically decrease the pulser voltage to remain below the system maximum. A decreasein pulser voltage will decrease MI.

Other

PULSED, CW, COLOR, PWR IMG, M MODE, COMP IMG, and 2D Imaging Controls

When a new imaging mode is selected, both the TI and MI may change to default settings.Each mode has a corresponding pulse repetition frequency and maximum intensity point.In combined or simultaneous modes, the thermal index is the sum of the contribution fromthe modes enabled and MI is the MI for the focal zone and mode with the largest deratedintensity. The system will return to the previously selected state if a mode is turned off andthen reselected.

Scanhead

Each scanhead model available has unique specifications for contact area, beam shape,and center frequency. Defaults will be initialized when you select a scanhead. ATL factorydefaults vary with scanhead, clinical option, Tissue Specific preset, and selected mode.Defaults have been chosen below the FDA limits for intended use.

DEPTH

An increase in 2D depth will automatically decrease the 2D frame rate. This woulddecrease the TI. The system may also automatically choose a deeper 2D focal depth. Achange of focal depth may change the MI. The MI displayed is that of the zone with thelargest peak intensity.

Clinical Options and Tissue Specific Presets

Acoustic output defaults are set when you select a Tissue Specific preset. ATL factorydefaults vary with scanhead, clinical option, Tissue Specific preset, and selected mode.Defaults have been chosen below the FDA limits for intended use.

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Related Guidance Documents

For more information about ultrasonic bioeffects and related topics refer to the following:

� “Bioeffects and Safety of Diagnostic Ultrasound.” AIUM Report, January 28, 1993.

� “Bioeffects Considerations for the Safety of Diagnostic Ultrasound.” Journal of Ultra-sound in Medicine, Vol. 7, No. 9 Supplement: September 1988.

� Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.AIUM, NEMA, May 1998.

� Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment. AIUM, Jan-uary 1998.

� Second Edition of the AIUM Output Display Standard Brochure, March 10, 1994. (Acopy of this document is shipped with each system.)

� Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultra-sound Systems and Transducers. FDA. September 1997.

� Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indiceson Diagnostic Ultrasound Equipment, Revision 1. AIUM, NEMA, 1998.

� WFUMB. “Symposium on Safety of Ultrasound in Medicine: Conclusions and Recom-mendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultra-sound”. “Ultrasound in Medicine and Biology, Vol. 24, Supplement 1: 1998.

Acoustic Output and MeasurementSince the initial use of diagnostic ultrasound, the possible human biological effects (bioef-fects) from ultrasound exposure have been studied by various scientific and medical insti-tutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratifieda report prepared by its Bioeffects Committee “Bioeffects Considerations for the Safety ofDiagnostic Ultrasound.” Journal of Ultrasound in Medicine, Vol. 7, No. 9 Supplement: Sep-tember 1988, sometimes referred to as the Stowe Report, which reviewed available dataon possible effects of ultrasound exposure. Another report “Bioeffects and Safety of Diag-nostic Ultrasound,” dated January 28, 1993, provides more current information.

The acoustic output for this system has been measured and calculated in accordance withthe “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment”(AIUM, NEMA 1998), the “Standard for Real-Time Display of Thermal and MechanicalAcoustic Output Indices on Diagnostic Ultrasound Equipment” (Revision 1, AIUM, NEMA,1998), and the September, 1997, FDA document “Information for Manufacturers SeekingMarketing Clearance of Diagnostic Ultrasound Systems and Transducers.”


In Situ, Derated, and Water Value Intensities

All intensity parameters are measured in water. Since water does not absorb acousticenergy, these water measurements represent a worst case value. Biological tissue doesabsorb acoustic energy. The true value of the intensity at any point depends on the amountand type of tissue and the frequency of the ultrasound that passes through the tissue. Theintensity value in the tissue, in situ, has been estimated by using the following formula:

In Situ = Water [e−(0.23alf)]

where: In Situ = In Situ Intensity Value

Water = Water Value Intensity

e = 2.7183

a = Attenuation Factor

Tissue = a(dB/cm--MHz)

Brain = .53

Heart = .66

Kidney = .79

Liver = .43

Muscle = .55

l = Skin line to measurement depth (cm)

f = Center frequency of the scanhead/system/mode com-bination (MHz)

Since the ultrasonic path during an examination is likely to pass through varying lengthsand types of tissue, it is difficult to estimate the true in situ intensity. An attenuation factor of0.3 is used for general reporting purposes; therefore, the in situ value which is commonlyreported uses the formula:

In Situ (derated) = Water [e−(0.069lf)]

Since this value is not the true In Situ intensity, the term “derated” is used.

Mathematical derating of water-based measurements, using the 0.3 dB/cm/MHz coeffi-cient, may yield lower acoustic exposure values than would be measured in a homoge-nous 0.3 dB/cm/MHz tissue. This is true because non-linearly propagating acousticenergy waveforms experience more distortion and saturation in water than in tissue,where attenuation present all along the tissue path will dampen the build up of non-lineareffects.

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The maximum derated and the maximum water values do not always occur at the sameoperating conditions; therefore, the reported maximum water and derated values may notbe related by the In Situ (derated) formula. For example: a multi-zone array scanhead thathas maximum water value intensities in its deepest zone, but also has the smallest derat-ing factor in that zone. The same scanhead may have its largest derated intensity in one ofits shallowest focal zones.

Conclusions Regarding Tissue Models and Equipment Survey

Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situfrom measurements of acoustic output made in water. Presently, available models may belimited in their accuracy because of varying tissue paths during diagnostic ultrasoundexposures and uncertainties in acoustical properties of soft tissues. No single tissuemodel is adequate for predicting exposures in all situations from measurements made inwater, and continued improvement and verification of these models is necessary for mak-ing exposure assessments for specific applications.

A homogeneous tissue model with an attenuation coefficient of 0.3 dB/cm--MHz through-out the beam path is commonly assumed when estimating exposure levels. The model isconservative in that it overestimates the in situ acoustic exposure when the path betweenthe transducer and the site of interest is composed entirely of soft tissue, because theattenuation coefficient of soft tissue is generally higher than 0.3 dB/cm--MHz. When thepath contains significant amounts of fluid, as in many first and second-trimester pregnan-cies scanned transabdominally, this model may underestimate the in situ acoustical expo-sure. The amount of underestimation depends on each specific situation.

Fixed-path tissue models, in which soft tissue thickness is held constant, sometimes areused to estimate In Situ acoustical exposures when the beam path is longer than 3 cm andconsists largely of fluid. When this model is used to estimate maximum exposure to thefetus during transabdominal scans, a value of 1 dB/MHz may be used during all trimesters.

Existing tissue models that are based on linear propagation may underestimate acousticalexposures when significant saturation due to non-linear distortion of beams in water ispresent during the output measurement.

The maximum acoustic output levels of diagnostic ultrasound devices extend over a broadrange of values:

� A survey of 1990-equipment models yielded mechanical index (MI) values between0.1 and 1 at their highest output settings. Maximum MI values of approximately 2 areknown to occur for currently available equipment. Maximum MI values are similar forreal-time 2D, M-mode, pulsed Doppler, and Color flow imaging.


� Computed estimates of upper limits to temperature elevations during transabdominalscans were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. Thevast majority of models yielded upper limits less than 1 degree C and 4 degrees C forexposures of first-trimester fetal tissue and second-trimester fetal bone, respectively.The largest values obtained were approximately 1.5 degrees C for first-trimester fetaltissue and 7 degrees C for second-trimester fetal bone. Estimated maximum temper-ature elevations given here are for a “fixed-path” tissue model and are for devices hav-ing ISPTA values greater than 500 mW/cm2. The temperature elevations for fetal boneand tissue were computed based on calculation procedures given in Sections4.3.2.1--4.3.2.6 in “Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993).”

Acoustic Output Tables

Acoustic output tables are found in HDI 5000 Ultrasound System Acoustic Output Tables,4706-0027-XX. All table entries have been obtained at the same operating conditions thatgive rise to the maximum index value in the first column of the tables.

Acoustic Measurement Precision and Uncertainty

Measurement precision and uncertainty for power, pressure, intensity, and center fre-quenc y ar e s hown in Table 7 -- 1 and Table 7 -- 2.

Table 7--1. Acoustic Measurement Precision

Per Section 6.4 of the Output Display Standard, measurement precision on the follow-ing quantities is determined by making repeated measurements and stating the stan-dard deviation as a percentage.

Quantity Precision(percentage standard deviation)

Pr is the un-derated and Pr.3 is the der-ated peak rarefactional pressure mea-sured in MegaPascals.

Pr: 2.2%Pr.3: 5.4%

Wo is the ultrasonic power in milliWatts. 6.2%

fc is the center frequency in MHz (NEMAUD--2 definition).

<1%

PII is the un-derated and PII.3 is thederated spatial-peak pulse intensity inte-gral in Joules/cm2.

PII: 3.2%PII.3: 3.2%

Note

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Table 7--2. Acoustic Measurement Uncertainty

Quantity Measurement Uncertainty(percentage, 95% confidence value)

Pr is the un-derated and Pr.3 is the der-ated peak rarefactional pressure mea-sured in MegaPascals.

Pr: 13%Pr.3 15%

Wo is the ultrasonic power in milliWatts. 19%

fc is the center frequency in MHz (NEMAUD--2 definition).

4.5%

PII is the un-derated and PII.3 is thederated spatial-peak pulse intensity inte-gral in Joules/cm2.

PII: +18% to --23%PII.3: +19% to --24%

HDI 5000 Scanheads and Safety 4701-0027-04 I--1

IndexAA c ous t ic out put m eas ur em ent , 7 -- 20

ALARA, 7 -- 10, 7 -- 12

Articulation, 3 -- 4, 4 -- 2

Artifacts, 2 -- 9

BB iologic al s af et y, 7 -- 9

Biopsyguideline dis play, 5 -- 1pr oc edur e, 5 -- 8

B iops y guide, 5 -- 1alignm ent , 5 -- 4at t ac hing, 5 -- 1m aint enanc e, 5 -- 9

BrakeMPT 7 -- 4, 3 -- 9syst em, 7 -- 5

CCaut ion, 7 -- 1

Clinic al opt ions , 2 -- 4

Com pac t dis c ( m anual s et ) , 1 -- 1

Cont r ol eff ec t s , 7 -- 17

Conv ent ions , 1 -- 2

Cus t om er c om m ent s , 1 -- 3

DDef ault t ables , 7 -- 23

Doppler ac c ur ac y, 2 -- 6

Doppler m ax im um m eas ur able v eloc it y, 2 -- 6

EElectrical safety, 7 -- 1

E lec t r os t at ic dis c har ge pads , 7 -- 4

E quipm ent pr ot ec t ion, 7 -- 5

GG uidanc e doc um ent s , 7 -- 20

HHelp, t her m al index , 7 -- 16

LLapar os c opic s c anhead, 4 -- 1

Loc k , B P T 9 -- 5, 3 -- 10

MMaintenance

biops y guide, 5 -- 9lapar os c opic s c anhead, 4 -- 6s c anhead, 2 -- 9t r ans es ophageal s c anhead, 3 -- 16

M anual s et , 1 -- 1

M ax im um m eas ur able v eloc it y, 2 -- 6

M ec hanic al s af et y, 7 -- 5

M ode s elec t ion lev er, 3 -- 10, 4 -- 3

OO ut put dis play, 7 -- 13

Index

HDI 5000 Scanheads and Safety 4701-0027-04I--2

PP r ec is ion, ac ous t ic m eas ur em ent , 7 -- 23

Probe covers, 6 -- 1

P r udent us e s t at em ent , 7 -- 9

SSafety

biologic al, 7 -- 9elec t r ic al, 7 -- 1equipm ent pr ot ec t ion, 7 -- 5m ec hanic al, 7 -- 5

S c anheads , 2 -- 1

Symbolssafety, 7 -- 7s c anheads , 2 -- 3

TTem per at ur e, 2 -- 1, 3 -- 14

T her m al index help, 7 -- 15

T her m al m onit or, 3 -- 14

Tip guar d, 3 -- 17

Tr ans es ophageal s c anhead, 3 -- 1

UUpgrades, syst em, 1 -- 3

WWar ning, 7 -- 1

Wr is t s uppor t , 7 -- 4