Procedure No.

474-20121219-01 ( Major ) Ultrasound Scanners

BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed.

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners

Ultrasound Scanners
Procedure No. 474-20121219-01 ( Major )

Used For:
Scannin* S,stems- Ultrasonic- ./ t almic 011-$192 Scannin* S,stems- Ultrasonic- .3stetric45,necolo*ic 016-7672 Scannin* S,stems- Ultrasonic- Porta3le 011-14$2 Scannin* S,stems- Ultrasonic- 8ascular 016-9672 Scannin* S,stems- Ultrasonic- Small-Parts 011-0622 Scannin* S,stems- Ultrasonic- Mammo*ra/ ic 016-7672 Scannin* S,stems- Ultrasonic- )3dominal 017-2412 Scannin* S,stems- Ultrasonic 014-2712 Scannin* S,stems- Ultrasonic- &ardiac 017-4222 Scannin* S,stems- Ultrasonic- (ntra+ascular 017-7472 Scannin* S,stems- Ultrasonic- 5eneral-Pur/ose 016-9772

Co

onl! Used "n:

&ardiolo*,- dia*nostic ima*in*- o3stetrics and *,necolo*,- o/ t almolo*,- radiolo*,- sur*er,- +ascular la3- emer*enc, de/artment

Sco#e:
9 is /rocedure co+ers all dia*nostic ultrasound scanners- includin* *eneral-/ur/ose and dedicated s,stems: t is /rocedure does not co+er nonima*in* dia*nostic ultrasound s,stems suc as ;o//ler 3lood-<lo= detectors and ;o//ler <etal eart monitors

$%s& 'e(el: Medium )!#e

Major Minor

"nter(al
12 Mont s 0 N)

)% e $e*u%red
0.6 ours 0 ours

+(er(%e,:
Ultrasound scanners t,/icall, /ro+ide 2-; ima*es o< so<t tissue <or a3dominal- o3stetric4*,necolo*iccardiac- small-/arts- and +ascular e>aminations. Scanners also /ro+ide =a+e<orms (M-mode)- and ne=er scanners a+e $-; ca/a3ilities. ?it s/eciall, desi*ned /ro3es- t e, can also 3e used <or intra+ascular and intrao/erati+e a//lications. BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. 2

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners Ultrasound re<ers to sound =a+es emitted at <re@uencies a3o+e t e le+el o< uman earin*. Aor dia*nostic ima*in*- <re@uencies ran*in* <rom 2 to 12 MBC are t,/icall, used. Ultrasound =a+es are mec anical +i3rations t at re@uire a medium <or transmission. Because t e, e> i3it t e normal =a+e /ro/erties o< re<lection- re<raction- and di<<raction- t e, can 3e /redicta3l, aimed- <ocused- and re<lected. %c oes are /roduced = ene+er t e 3eam encounters an inter<ace o< di<<erent acoustic im/edances- suc as t e so<t-tissue43one inter<ace. Dar*e di<<erences in tissue acoustic im/edance c aracteristics result in a i* de*ree o< re<lection. ) transducer- = ic consists o< one or more /ieCoelectric elements- is /laced on t e s!in a<ter an acoustic cou/lin* *el is a//lied. 9 e transducer con+erts an electrical si*nal into ultrasonic ener*, t at can 3e transmitted into tissues. ? en t is ultrasonic ener*, is re<lected 3ac! <rom t e tissues- t e transducer recon+erts it to an electrical si*nal. 9 e scanner s,stem measures t e intensit, o< t e ec oest e time 3et=een t em- and t eir direction. 9 is in<ormation is t en /rocessed and used to *enerate a dis/la, in one o< se+eral modes. ) scan con+erter s,stem stores t e re+ie= ec oes <or dis/la, on a i* resolution monitor. ;urin* scannin*- t e con+erter assi*ns discrete s ades o< *ra, (*ra, scale) to t e returnin* ec o am/litude le+els: t e num3er o< s ades de/ends on o= man, 3its o< in<ormation can 3e stored <or eac oriContal and +ertical /oint o< ima*e memor,. Some scanners o<<er user-selecta3le /re/rocessin* and /ost/rocessin* <eatures t at /ermit t e o/erator to o/timiCe t e ima*e @ualit, 3, alterin* t e te>ture and *ra,-scale em/ asis =it in t e ima*e. ) data-entr, !e,3oard /ermits in<ormation- suc as /atient name- date- and t,/e o< stud,- to 3e entered and dis/la,ed alon* =it t e scanned ima*e. (n some s,stems- an al/ anumeric !e,3oard interacts =it a com/uter to /ermit mani/ulation o< t e dis/la,ed ima*e or s,stem o/eratin* /arameters. (n cardiac and +ascular studies- t e ;o//ler e<<ect is used to determine t e direction and s/eed o< 3lood <lo=. 9 is /rinci/le states t at sound =a+es increase in <re@uenc, = en t e, ec o <rom o3jects (in t is case- red 3lood cells) mo+in* to=ard t e sound source and decrease in <re@uenc, = en t e, ec o <rom o3jects mo+in* a=a, <rom it. 9 is c an*e in <re@uenc,- = ic is related to t e +elocit, o< t e mo+in* red 3lood cells- is t en measured and used to determine 3lood <lo= +elocit,. ;o//ler color <lo= ma//in* (&AM) simultaneousl, assesses t e direction and relati+e +elocit, o< 3lood <lo= at multi/le /oints alon* multi/le 3eam /at s. 9 e result is an ima*e o< t e emod,namics o< t e eart and *reat +essels- = ic is use<ul <or detectin* +al+e de<ects and stenoses. )s con+entional 2-; real-time tec ni@ues dis/la, t e eartEs anatomic <eatures in 3lac! and = ite- color su/erim/osed on t is ima*e +isuall, de/icts t e direction and +elocit, o< 3lood <lo=. &AM com/lements and en ances t e dia*nostic +alue o< con+entional 2-; real-time ima*es: it also /ro+ides more in<ormation a3out and ena3les 3etter @uanti<ication o< t e direction and +elocit, o< 3lood <lo= a3normalities.

)est -##aratus and Su##l%es:

Multi/ur/ose tissue mimic!in* / antom ;o//ler ultrasound / antom Blood <lo= simulator %&5 simulator

S#ec%al Precaut%ons: Some /arts o< t Procedure:

e ultrasound e@ui/ment- es/eciall, t e transducers- ma, 3e e>/osed to 3lood and 3od, <luids so s/ecial /recautions s ould 3e a//lied.

Be sure t at ,ou understand o= to o/erate t e e@ui/ment- t e si*ni<icance o< eac control and indicatorand t e alarm ca/a3ilities. Be<ore 3e*innin* an ins/ection- care<ull, read t is /rocedure- t e o/erators manual- and t e ins/ection and /re+enti+e maintenance /rocedures recommended 3, t e manu<acturer BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. $

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners (t,/icall, included in t e ser+ice manual). Use t e BiomedicalBenc mar! Su//ort )ssessment Aorm to document a maintenance decision t at re<lects /ast e>/erience =it t is t,/e o< e@ui/ment and t e en+ironment = ere it is used. 9 en use t e (PM Procedure &ustomiCation 9ool to modi<, t is /rocedure as needed. NoteF 9 is /rocedure re@uires a dedicated <orm (seeF ;edicated (PM Aorms ta3). 9 e <orm must 3e manuall, c an*ed to corres/ond =it c an*es made to t e /rocedure. ) ;o//ler ultrasound / antom is re@uired onl, <or a com/re ensi+e e+aluation o< ultrasound scanners t at a+e ;o//ler ca/a3ilities and a 3lood <lo= simulator is re@uired i< onl, t e 3asic o/eration o< ultrasound scanners =it ;o//ler is 3ein* c ec!ed. )n %&5 simulator is needed onl, <or cardiolo*, ultrasound s,stems or *eneral-/ur/ose s,stems =it cardiac o/tions. Ai*ure 1. 9issue mimic!in* / antom t,/ical line tar*et *rou/s and corres/ondin* scanner ima*es <or Guantitati+e 9as!s. Scannin* Sur<ace

). ;ead HoneF Nine tar*ets- /ositioned 2 mm t rou* 10 mm <rom t e scannin* sur<ace. B. )>ial 'esolutionF Si> line tar*ets- /ositioned =it 1 mm- 2 mm- $ mm- and 6 mm se/arations. &. Dateral 'esolutionF Si> line tar*ets- /ositioned =it 1 mm- 2 mm- $ mm- 4 mm- and 6 mm se/arations. ;. 8ertical ;istanceF %le+en line tar*ets- /ositioned =it 10 mm se/arations. %. BoriContal ;istanceF Se+en line tar*ets- /ositioned =it 10 mm se/arations.

(ma*e =it all line tar*et *rou/s dis/la,ed.

(ma*e s o=in* 4 mm dead Cone- 1 mm a>ial resolution- and $ mm lateral resolution.

(ma*e s o=in* normal +ertical-distance cali3ration. BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. 4

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners

(ma*e s o=in* normal oriContal-distance cali3ration. )dd an additional 6 minutes o< (PM time <or eac additional transducer. (nter+al NoteF Per<orm t e <ollo=in* tests = ene+er a ne= or re/aired transducer is to 3e usedF (1) 9ransducer (denti<ication and Scanner Settin*s <or tests =it t e tissue mimic!in* ultrasound / antom: (2) ;ead Hone: ($) )>ial 'esolution: (4) Dateral 'esolution: (6) 8ertical ;istance: (7) BoriContal ;istance: and4or (7) ;o//ler &ali3ration. 9est )//aratus NoteF S/eci<ications <or a tissue mimic!in* ultrasound / antom ) tissue mimic!in* / antom is re@uired to com/re ensi+el, e+aluate t e /er<ormance o< dia*nostic ultrasound ima*in* s,stems. Some multi/ur/ose / antoms do not contain all o< t e recommended ca/a3ilities. 9o e+aluate 3ot *eneral-/ur/ose and small-/arts scanners- it ma, 3e necessar, to ac@uire more t an one / antom to /er<orm all o< t e recommended tests. 5eneral testin* ca/a3ilities o< t e / antom s ould includeF ;ead-Cone or rin*-do=n 8ertical and oriContal measurement cali3ration Aocal Cone Sensiti+it, )>ial and lateral resolution Aunctional resolution 5ra,scale and dis/la,ed d,namic ran*e 9 e / antom s ould 3e desi*ned =it a com3ination o< mono<ilament line tar*ets and tissue-mimic!in* c,lindrical tar*ets o< +ar,in* siCes and contrasts. 9 e mono<ilament line tar*ets s ould a+e a diameter o< 0.1 mm to 0.6 mm I6J to o/timiCe t e dis/la,ed ima*e at <re@uencies t,/icall, used on *eneral/ur/ose scanners. Mono<ilament line tar*ets =it diameters o< a//ro>imatel, 0.6 mm s ould 3e /resent to o/timiCe t e dis/la,ed ima*e at t e i* ultrasound <re@uencies t,/icall, used on small-/arts scanners. Aor dead-Cone or rin*-do=n e+aluation- at least 7 mono<ilament line tar*ets s ould 3e /resent at de/t s ran*in* <rom 2 mm to 10 mm. Aor +ertical distance measurement cali3ration- t e mono<ilament line tar*ets s ould a+e an inter+al s/acin* o< 1 cm at a de/t o< 1 cm to a total de/t o< at least 11 cm. 9o e+aluate small-/arts scanners- an inter+al s/acin* o< 0.6 cm is recommended. Aor oriContal distance measurement cali3ration- t e mono<ilament line tar*ets s ould a+e an inter+al s/acin* o< 1 or 2 cm. 9o e+aluate small-/arts scanners- an inter+al s/acin* o< 0.6 cm is recommended. 9ar*ets s ould 3e a+aila3le at more t an one de/t <or accurate determination o< oriContal distance measurement cali3ration. Aor a>ial and lateral resolution e+aluation- multi/le mono<ilament line tar*ets are re@uired =it inter+al s/acin*s o< 1 mm- 2 mm- $ mm- 4 mm- and 6 mm or less. 9o e+aluate small-/arts scanners- t e smaller inter+al s/ace s ould 3e 0.6 mm or less. 9ar*ets s ould 3e a+aila3le at more t an one de/t to /ro/erl, e+aluate lateral resolution. 9 e / antom s ould contain multi/le anec oic (nonec o*enic) c,lindrical tar*et structures o< +ar,in* siCes <rom 2 mm to at least 7 mm. )nec oic tar*et structures =it a 1 mm diameter are recommended = en e+aluatin* ultrasound scanners t at are routinel, used <or small /arts. 9 e / antom s ould contain multi/le *ra,scale (ec o*enic) c,lindrical tar*ets- cali3rated in deci3els (dB)- to e+aluate t e dis/la,ed d,namic ran*e and *ra,scale /rocessin* /er<ormance. BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. 6

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners 9 e / antom s ould 3e constructed o< a tissue-mimic!in* material =it a recommended attenuation coe<<icient o< 0.6 dB4cm4MBC to 0.7 dB4cm4MBC. 9 e +elocit, cali3ration o< t e tissue-mimic!in* material s ould 3e 1-640 meters /er second at room tem/erature. 9 e dimensions o< t e scannin* sur<ace s ould 3e su<<icientl, lar*e to /ermit e+aluation o< t e lon*est <lat linear-arra, transducer. 9 e / antom s ould 3e contained in a /rotecti+e ousin*. ) 3uilt-in scannin* =ell is recommended to /ermit t e use o< =ater or a lo=-+iscosit, *el as t e cou/lin* a*ent. ) dee/ scannin* =ell- eit er 3uilt-in or remo+a3le- is recommended <or /ro/er e+aluation o< some endoscannin* transducers. S/eci<ications <or a ;o//ler ultrasound / antom ) cali3rated ;o//ler <lo= / antom is re@uired onl, <or a com/re ensi+e e+aluation o< ultrasound scanners t at incor/orate continuous-=a+e- /ulsed-=a+e- or color-<lo= ;o//ler ca/a3ilities. Some ;o//ler / antoms are desi*ned s/eci<icall, <or e+aluatin* eit er /eri/ eral +ascular or cardiac s,stems. 5eneral testin* ca/a3ilities o< t e / antom s ould includeF Alo= +elocit, Docation o< <lo= ;irectional discrimination 9 e / antom can 3e eit er t e tissue-mimic!in* t,/e =it one or more <luid-<lo= c annels (containin* a nonde*radea3le 3lood-mimic!in* solution =it cali3rated re<lectin* tar*ets) or t e t,/e t at incor/orates a mo+in* strin* tar*et =it in a <luid-<illed container. 9 e strin* / antom /ro+ides *reater accurac, <or <lo= +elocit, cali3ration. Aor /eri/ eral +ascular s,stem e+aluation- t e tar*et(s) =it in t e / antom s ould mo+e /arallel to t e / antomEs scannin* sur<ace (/er/endicular to t e transducerEs 3eam /at ). Aor cardiac s,stem e+aluationt e tar*et(s) =it in t e / antom s ould mo+e at an an*le o< a//ro>imatel, 46 to t e / antomEs scannin* sur<ace. )lt ou* not o/timum- / antoms desi*ned s/eci<icall, <or cardiac s,stem e+aluation can 3e used to e+aluate /eri/ eral +ascular s,stems. 9 e / antom s ould /ro+ide user-+aria3le +elocit, o< t e mo+in* tar*et(s). 9o c ec! onl, 3asic ;o//ler o/eration- it is not necessar, to use t e cali3rated ;o//ler / antoms descri3ed a3o+e. ) less-costl, 3lood-<lo= simulator ma, 3e /urc ased- or one ma, 3e constructed usin* a <luid /um/ and <le>i3le tu3in* su3mer*ed =it in a <luid-<illed container. (n lieu o< t e nonde*radea3le 3lood-mimic!in* solution =it cali3rated re<lectin* tar*ets- an, ec o*enic <luid- suc as a deter*ent=ater solution- ma, 3e used.

.ual%tat%(e tas&s: C/ass%s01ous%n2.

%>amine t e e>terior o< t e scanner <or cleanliness and *eneral / ,sical condition. Be sure t at /lastic ousin*s are intact- t at all ard=are is /resent and ti* t- and t at t ere are no si*ns o< s/illed li@uids or ot er serious a3use. Mount0Fasteners. (< t e scanner is mounted on a stand or cart- e>amine t e condition o< t e mount. (< it rests on a s el<c ec! t e securit, o< t is attac ment. Casters03ra&es. (< t e scanner mo+es on casters- c ec! t eir condition. 8eri<, t at t e, turn and s=i+el- as a//ro/riateand loo! <or accumulations o< lint and t read around t e casters. & ec! t e o/eration o< 3ra!es and s=i+el loc!s- i< t e scanner is so e@ui//ed. BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. 7

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners

-C Plu20$ece#tacles. %>amine t e )& /o=er /lu* <or dama*e. )ttem/t to =i**le t e 3lades to c ec! t at t e, are secure. S a!e t e /lu* and listen <or rattles t at could indicate loose scre=s. (< an, dama*e is sus/ected- o/en t e /lu* and ins/ect it. (< t e scanner as electrical rece/tacles <or accessories- +eri<, t e /resence o< line /o=er- and insert an )& /lu* into eac and c ec! t at it is eld <irml,. (< accessories are /lu**ed and un/lu**ed o<tenconsider a <ull ins/ection o< t e rece/tacles. '%ne Cord. (ns/ect t e cord <or si*ns o< dama*e. (< dama*ed- re/lace t e entire cord or- i< t e dama*e is near one end- cut out t e de<ecti+e /ortion. Stra%n $el%e4s. %>amine t e strain relie<s at 3ot ends o< t e line cord. Be sure t at t e, old t e cord securel,. Ca5les. (ns/ect an, ca3les (e.*.- transducer) and t eir strain relie<s <or *eneral condition. &are<ull, e>amine ca3les to detect 3rea!s in t e insulation and to ensure t at t e, are *ri//ed securel, in t e connectors at eac end to /re+ent rotation or ot er strain. 8eri<, t at t ere are no intermittent <aults 3, <le>in* electrical ca3les near eac end and loo!in* <or erratic o/eration or 3, usin* an o mmeter. )ransducers. & ec! t e sur<ace areas o< ultrasound transducers <or deterioration- crac!s- or dents in t e mem3rane. & ec! t e acoustic <luid o< mec anicall, steered transducers: re<ill =it t e recommended <luid i< air 3u33les are /resent. F%lters. & ec! t e condition o< all air +ents and <ilters. &lean or re/lace <ilters- i< a//ro/riate- and document under /re+enti+e maintenance. Controls0S,%tc/es. %>amine all controls and s=itc es <or / ,sical condition- secure mountin*- and correct motion. & ec! t at control !no3s a+e not sli//ed on t eir s a<ts. ? ere a control s ould o/erate a*ainst <i>ed-limit sto/s- c ec! <or /ro/er ali*nment- as =ell as /ositi+e sto//in*. ;urin* t e course o< t e ins/ection- 3e sure to c ec! t at eac control and s=itc /er<orms its /ro/er <unction. Fans. BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed. 7

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners & ec! t e / ,sical condition and /ro/er o/eration o< t e s,stemEs coolin* <an(s)- i< /resent. &lean and lu3ricate t e <an(s) i< re@uired and document under /re+enti+e maintenance. "nd%cators06%s#la!s. 'ecord t e readin* o< an our meter- i< /resent. ;urin* t e course o< t e ins/ection- con<irm t e o/eration o< all lam/s- indicators- meters- *au*es- and +isual dis/la,s on t e scanner. Be sure t at all se*ments o< a di*ital dis/la, <unction. .3ser+e an ima*e on t e &'9 dis/la,- and c ec! its @ualit, (e.*.distortion- <ocus- 60470 BC noise). )lso +eri<, ima*e @ualit, o< /eri/ eral accessories (e.*.- /rinter8&'). Sel4-)est. Aor units =it a sel<-test mode- acti+ate it and determine i< t e e>/ected res/onse is /roduced. (Major)cce/tance) )% e06ate Sett%n2s. 8eri<, t at t e time and date settin*s on t e unit are correct. Net,or&07%reless "nter4aces. 'e+ie= measures ta!en to ensure /rotection a*ainst t e /otential ris!s and +ulnera3ilities to t e con<identialit,- inte*rit,- and a+aila3ilit, o< electronic in<ormation stored or transmitted 3, t e de+ice or s,stem and +eri<, t at /re+enti+e measures are still acti+e. Aor e>am/le- are /ass=ords 3ein* a//lied correctl,- a+e o/eratin* s,ste- and +irus /rotection /atc es and u/*rades 3een installed- is t e de+ice still o/eratin* on a 8PN (+irtual /ri+ate net=or!) and are =ireless securit, measures still in /lace. 8eri<, t at data 3ac!u/ /rocesses are acti+ated and t at data can 3e retrie+ed <rom 3ac!u/s. User Cal%5rat%on. 8eri<, t at an, cali3ration <unctions are o/eratin*. (? ere a @uantitati+e c ec! is re@uired- it is included in t e Guantitati+e tas!s section.) -ud%5le S%2nals. ./erate t e scanner to acti+ate an, audi3le si*nals. &on<irm a//ro/riate +olume- as =ell as t e o/eration o< a +olume control- i< so e@ui//ed. 'a5el%n2. & ec! t at all necessar, /lacards- la3els- con+ersion c arts- and instruction cards are /resent and le*i3le. S!ste Per4or ance. 1

BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed.

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners Use t e multi/ur/ose ultrasound / antom to e+aluate t e o+erall /er<ormance o< t e scanner. Use t e test o3jectEs multi/le *ra,-scale (ec o*enic) tar*ets to e+aluate t e dis/la,ed d,namic ran*e and *ra,scale /rocessin* /er<ormance. Use t e multi/le anec oic (nonec o*enic) c,lindrical tar*ets to o3ser+e t e a3sence o< ec o*enicit,. 9 e anec oic tar*et s ould 3e clearl, resol+ed. Bi* er-<re@uenc, transducers s ould /roduce t e clearest ima*es o< t e smaller anec oic tar*ets. Usin* normal *ain and out/ut /o=er settin*s- c ec! <or sensiti+it,4/enetration relati+e to t e <re@uenc, o< t e transducer 3ein* used. (See t e ta3le) & ec! multi<re@uenc, transducers at eac o/eratin* <re@uenc, and +eri<, t e o/eration o< t e armonic ima*in* <unction- i< a//lica3le. 9,/ical sensiti+it,4/enetration o< a tissue mimic!in* / antom 9ransducer Are@uenc,- MBC Penetration- cm 1.9 20 2.6 11 $.0 17 $.6 16 6.0 1 7.6 6 10.0 $ Use a 3lood-<lo= simulator to c ec! t e 3asic o/eration o< t e ;o//ler s,stem- i< installed. 8C9. Usin* an %&5 simulator- +eri<, normal o/eration o< ultrasound scanners con<i*ured <or ec ocardio*ra/ ,- accordin* to t e <ollo=in* criteriaF 9 e 3aseline s ould a+e constant t ic!ness: it s ould 3e oriContal and not dri<t +erticall,. .n s,stems e@ui//ed =it a /osition control- c ec! t e ran*e o< mo+ement. )ll /ortions o< a simulated %&5 =a+e<orm s ould 3e clearl, +isi3le- includin* t e P =a+e and G'S com/le>. 60470 BC noise s ould not 3e /resent. 9 e accurac, o< inter+als 3et=een t e timin* mar!s dis/la,ed 3, t e scanner s ould 3e consistent =it t e timin* o< t e %&5 simulator.

-ccessor%es. &on<irm t e /resence and condition o< accessories (e.*.- transducers and cou/lin* *el). 8eri<, t at e>/iration dates a+e not 3een e>ceeded. ) co/, o< t e o/erators manual s ould 3e readil, a+aila3le to t e o/erators.

.uant%tat%(e tas&s: 9round%n2 $es%stance.

Measure t e resistance 3et=een t e *roundin* /in o< t e /o=er cord (i< so e@ui//ed) and e>/osed (un/ainted and not anodiCed) metal on t e c assis. 5roundin* resistance s ould not e>ceed 0.6 K. (< t e unit is dou3le insulated- *roundin* resistance need not 3e measured. )ransducer "dent%4%cat%on and Scanner Sett%n2s 4or )ests ,%t/ t/e Mult%#ur#ose Ultrasound P/anto .

BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed.

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners 'ecord transducer identi<ication and instrument settin*s <or eac transducer as noted in t e ta3le <or t e S,stem Per<ormance tas!. Set t e controls <or o/timum /enetration and ima*e @ualit, <or eac transducer and <re@uenc, to 3e tested. ) /icture or /rintout s ould 3e made to document t e ima*e o3tained =it eac transducer. Most e@ui/ment /arameters =ill 3e dis/la,ed on t ese ard-co/, recordin*s. See Ai*ure 1 <or re<erence scanner ima*es. 9ransducer (denti<ication 9,/e Serial No. Are@uenc, ('an*e) MBC Scanner Settin*s Are@uenc, MBC Po=er dB Master 5ain dB ;,namic 'an*e dB Pre/rocessin* Post/rocessin* 9ransmit Aocal 'an*e cm .t erF

6ead :one. Place t e transducer o+er t e dead Cone line tar*et *rou/. ;etermine t e minimum distance (in mm) at = ic t e scanner can resol+e indi+idual structures. (See Ai*ure 1 in Procedure section.) -;%al $esolut%on. Place t e transducer o+er one o< t e a>ial resolution line tar*et *rou/s. ;etermine t e minimum re<lector se/aration (in mm) alon* t e a>is o< t e transducer 3eam re@uired to /roduce se/arate re<lections. (See Ai*ure 1 in Procedure section.) 'ateral $esolut%on. Place t e transducer o+er eac lateral resolution line tar*et *rou/. ;etermine t e minimum re<lector se/aration (in mm) /er/endicular to t e sound /at needed to /roduce discrete re<lections. Because lateral resolution can +ar, =it de/t - multi/le transducer locations s ould 3e used. (See Ai*ure 1 in Procedure section.) 'ecord t e lateral resolution <or eac de/t c ec!ed. (< t e transducer as adjusta3le transmit <ocus- +eri<, its o/eration and /er<orm eac lateral resolution measurement in t e res/ecti+e <ocal Cone- i< /ossi3le. <ert%cal 6%stance. Place t e transducer o+er a +ertical distance cali3ration line tar*et *rou/. Use t e scannerEs di*ital cali/ers and4or mar!er *rids to determine t e accurac, o< linear measurements alon* t e a>is o< t e transducer 3eam at 20 mm and 100 mm measured distances. (See Ai*ure 1 in Procedure section.) 1or%=ontal 6%stance.

BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed.

10

Procedure No. 474-20121219-01 ( Major ) Ultrasound Scanners Place t e transducer o+er a oriContal distance cali3ration line tar*et *rou/. Use t e scannerEs di*ital cali/ers and4or mar!er *rids to determine t e accurac, o< linear measurements /er/endicular to t e sound /at . (See Ai*ure 1 in Procedure section.) .n ima*es /roduced 3, <lat se@uenced linear-arra, transducers- c ec! at 20 mm and 70 mm measured distances- usin* an, le<t to ri* t location. .n ima*es /roduced 3, sector transducers- c ec! at 20 mm and 70 mm measured distances- 3ut at multi/le le<t to ri* t /ositions. (< t e transducer as adjusta3le transmit <ocus- /er<orm measurements =it in t e <ocal Cone- i< /ossi3le. 6o##ler Cal%5rat%on . (< a cali3rated ;o//ler ultrasound / antom is a+aila3le- +eri<, t e accurac, o< <lo= +elocit,- directional discrimination- and- i< a//lica3le- /ulsed-;o//ler *ate /ositionin*. Measurement /arameters and dis/la, @ualit, s ould not +ar, 3et=een ins/ections =it t e same transducer con<i*uration- scanner settin*sand tec ni@ue.

Pre(ent%(e Ma%ntenance: Clean.

&lean t e scanner e>terior- as =ell as t e interior i< needed. Use onl, manu<acturer-a//ro+ed solutions on t e scannin* sur<aces o< transducers. &lean t e e>terior and t e interior o< ima*e recordin* de+icesincludin* multi-ima*e cameras- +ideo /a*e /rinters- and 8&'s. 'u5r%cate. Du3ricate mo+in* /arts- includin* = eels- casters- and dra=er slides. $e4%ll. 'e<il mec anicall, steered transducers =it t e recommended acoustic <luid i< air 3u33les are /resent. Clean. &lean air +ents and or <ilters- i< re@uired.

BiomedicalBenc mar!" # 201$ %&'( (nstitute. )ll 'i* ts 'eser+ed.

11