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Transcription:

USER GUIDE

FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 +1-888-482-9449 +1-425-951-1200 +1-425-951-1201 FUJIFILM SonoSite B.V. Joop Geesinkweg 140 1114 AB Amsterdam, FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE, NSW, 2100 SonoSite SII SonoHD2 SonoMB SonoSite SONOSITE FUJIFILM SonoSite, Inc. DICOM (National Electrical Manufacturers Association) FUJIFILM FUJIFILM Corporation US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US 8,527,033; US 8,500,647;US 8,376,103; US 8,216,146; US 8,213,467; US 8,137,278; US 8,066,642; US 7,978,461; US 7,804,970; US 7,740,586; US 7,686,766; US 7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US 6,371,918; US 6,364,839; US 6,135,961; US 5,893,363; US 5,817,024; US 5,782,769; US 5,722,412; US 8,805,047; US 8,527,033; US 8,858,436; US 8,861,822; US 8,956,296; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CA 2,373,065; CN103237499; CN101231457; CN 97113678.5; CN 98106133.8; CN 200830007734.8; EP 0875203; EP 0881492; EP 1175713; EP P22783-01; EP 1180971; EP 1552792; EP 1589878; JP 5782428; JP 4696150; KR 528102; KR 532359 P20554-03 2017 11 2017 FUJIFILM SonoSite, Inc. ii

1.... 1-1... 1-2 2.... 2-1... 2-1... 2-2... 2-2... 2-3... 2-4... 2-5... 2-6 USB... 2-7... 2-9...2-10...2-11...2-11...2-12...2-12...2-13...2-14...2-14...2-15 3.... 3-1... 3-2... 3-2... 3-3... 3-5... 3-5... 3-6 iii

... 3-6... 3-6... 3-7... 3-8... 3-9...3-10...3-10...3-10...3-11...3-11...3-12 USB...3-12 JPEG...3-13 4.... 4-1... 4-1 M... 4-3... 4-4... 4-6... 4-7... 4-8 Steep Needle Profiling... 4-8...4-10...4-11...4-11...4-12...4-16...4-17...4-19...4-20...4-20...4-21...4-23 iv

5.... 5-1... 5-1... 5-3... 5-4 M... 5-5... 5-6... 5-7... 5-7... 5-8... 5-8...5-10 MSK...5-15 (Gyn)...5-16...5-17...5-20 MSK...5-21 6.... 6-1... 6-2... 6-2... 6-3... 6-8...6-10...6-12...6-13 7.... 7-1... 7-2... 7-3... 7-4 v

8.... 8-1... 8-2 Spaulding... 8-2... 8-3... 8-8...8-10...8-11...8-12...8-12 9.... 9-1... 9-2... 9-2... 9-3... 9-4... 9-4... 9-6... 9-6... 9-7... 9-7... 9-8... 9-9... 9-9...9-10...9-11...9-12...9-16...9-20...9-20...9-21...9-21...9-21...9-22 vi

...9-22...9-22...9-23...9-23...9-23...9-23 EMC...9-24...9-24...9-24 DICOM...9-24 HIPAA...9-25 10. ALARA...10-1 ALARA...10-1...10-2...10-2...10-2...10-2 MI TI...10-3...10-6...10-7...10-8...10-8...10-9...10-9...10-10...10-11...10-11...10-46...10-47 vii

11. IT... 11-1... 11-1... 11-1... 11-1... 11-2... 11-2... 11-2 A....A-1...A-2...B-1 viii

SonoSite SII SonoSite SII 1 FUJIFILM SonoSite rp19x HFL38xi L25x USB rp19x HFL38xi L25x USB 9-16 A-1 1-1

FUJIFILM SonoSite +1-877-657-8118 +1-425-951-1330 +1-425-951-6700 ffss-service@sonosite.com www.sonosite.com +31 20 751 2020 +44 14 6234 1151 +33 1 8288 0702 +49 69 8088 4030 +39 02 9475 3655 +34 91 123 8451 +65 6380-5581 1-2

SonoSite SII SonoSite SII 2 S-Total S-Vascular S-Vet 7-2 FUJIFILM SonoSite USB USB 1 2-2 2-1 2 3 Patient Information 4 Mode 2D 2-1

USB 2-1 USB RJ45 HDMI 2-1 2-2

USB HDMI HDMI 1 2 3 2-3

4 1 2 3 9-23 FUJIFILM SonoSite 2-4

1 2-2 2-1 2 FUJIFILM SonoSite 2-2 2-1 3-7 2-5

SonoSite SII 1 2 3 4 5 2-6

1 2 USB USB PC USB USB PC USB USB USB USB USB USB USB USB USB USB USB USB USB USB FAT-32 2-7

USB USB USB 2-2 2-1 USB USB USB USB 1 USB 2 USB 2-8

1 2 3 4 8 5 9 6 1 3 9 5 7 7 8 9 2 4 6 2-2 2-9

SonoSite SII 2-3 2-10

2-4 (ROI) M Select 2-11

2-5 SonoSite SII 2-12

USB USB USB TAB FUJIFILM SonoSite USB USB 1 2 Äñ Symbols Shift Delete 3 Next Prev 4 OK 2D 2-13

21 CFR 801.437 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 8-1 FUJIFILM SonoSite Aquasonic 1 2 3 4 5 2-14

SonoSite SII 4-12 CPD MI/TI 10-1 (PUBS) in vitro (IVF) CPD (IUGR) 2-15

(Oph) FDA (Oph) SonoSite SII 2-16

3-3-2-3-6-3-7-3-8-3-9-3-10-3-10-3-11-3-11-3-12 USB - USB 3-12 USB 1 Settings 2 Settings Pages 3 Done 3-1

Administration USB 1 Administration Name Administrator 2-13 Name Password 2 Password FUJIFILM SonoSite 1-2 3 Login 1996 (Health Insurance Portability and Accountability Act, HIPAA) (European Union Data Protection Directive, 95/46/EC) HIPAA 3-2

User Login 1 2 User Login On On Off 1 Administrator 2 User List Administrator 3 a User Information Password b Confirm 3-6 4 Password changes 5 Save USB 1 Administrator 2 Disable USB Export USB 1 Administrator 2 New 3 User Information Name Password Confirm 3-6 User User Administration Access 3-3

4 Save 1 Administrator 2 User List 3 User Information 4 Save 1 Administrator 2 User List 3 Delete 4 Yes 1 Administrator 2 User List 3 Password Confirm 4 Save 1 USB 2-7 USB 2 Administrator 3 Export USB 4 USB Export USB 3-4

1 USB 2-7 USB 2 Administrator 3 Import 4 USB Import 5 Restart USB PC 3-3 1 2 User Login OK 1 2 User Login Guest 1 2 User Login Password 3 OK 3-5

(A-Z) (a-z) (0-9) Annotations 4-16 4-16 1 Annotations Exam 2 Group A B C 3 a <New> b Text c Add 4 a b Text c Rename 5 a b 6 Delete 2-13 3-6

Annotations Unfreeze Keep All Text Keep Home Text Clear All Text Keep All Text 4-16 1 USB 2 Annotations Export USB 3 USB Export USB 1 USB 2 Annotations Import 3 USB Import 4 OK USB Audio, Battery On Off On Off 3-7

Off Off 5 10 15 30 Off Off 15 30 Connectivity PDAS Image Manager DICOM PDAS DICOM 1 2 Connectivity Printer 3 DVD 1 Connectivity Video Mode NTSC PAL 2 3 DVD PDAS 1 Connectivity Transfer mode PDAS 2 3 Connectivity PDAS setup 4 PDAS PDAS Save 3-8

5 a New b PDAS c Save 6 PDAS a PDAS USB b PDAS Import c USB Import 7 PDAS a USB b PDAS Export c USB Export 8 Done DICOM 1 Connectivity Transfer mode DICOM 2 3 Connectivity DICOM Setup DICOM 4 DICOM DICOM 5 Verify DICOM 6 Done Connectivity Internal Storage Capacity Alert 1 Date and Time a Date 2-13 b Time 24 3-9

Display Information ID Patient Header 4-17 Mode Data System Status Footswitch Footswitch (L) Footswitch (R) Save Clip Freeze Save Image Print FUJIFILM SonoSite 1 USB USB 2 Footswitch Network Status IP MAC 3-10

OB Calculations 5-17 OB Calculations Gestational Age None Presets Depth Markers 1 2 Thermal Index TIS TIB TIC OB TIB TIS Clip Length Units in/ft/lbs cm/m/kg Language Auto save Pat.Form 3-11

Save Key Save Image Only Image/Calcs Duplex M 1/3 2D, 2/3 Trace 1/3 2D 2/3 1/3 2/3 1/2 2D, 1/2 Trace 1/2 2D 1/2 1/2 Full 2D, Full Trace 2D System Information 7-3 System Information Patents USB USB Devices USB USB USB USB USB 3-3 USB 3-12

H.264 MP4 1 USB Devices USB Export 2 PDAS JPEG JPEG 3 Sort By 4 Devices 1 DICOM FUJIFILM SonoSite 2 USB Devices USB Include private tags FUJIFILM SonoSite DICOM JPEG JPEG lossy compression BMP JPEG 100% 0 90% 75% SonoCalc IMT BMP SonoCalc IMT 3-13

"Physics in Medicine and Biology, Quality Assessment of DSA, Ultrasound and CT Digital Images Compressed with the JPEG Protocol," D Okkalides et al.1994 Phys Med Biol 39 1407-1421 doi: 10.1088/0031-9155/39/9/008 www.iop.org/ej/abstract/0031-9155/39/9/008 "Canadian Association of Radiologists, CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology," Approved: June 2008. www.car.ca/files/%5clossy_compression.pdf 3-14

SonoSite SII (LCD) 4-12 4 3-11 1 2D 2 More Controls 4-1

4-6 4-1 Gain Depth Auto Gain Optimize THI SonoMB Orientation Guide Dual Monitor Gain Depth 4-6 Res Gen Pen THI SonoMB MB U/R / U/L / D/L / D/R / Guide A B C A B C Guide Dual Update Off Monitor 8 1 10 4-2

M M M 1 M M 2 M 3 4 M M M 4-2 M Gain Depth M line position M Scan speed Gain Depth M Fast Med Slow M 1 M 2 4-6 3 M 4-3

4 M 3-11 200 5 Slow Med Fast Update M M Update 2D M M (CPD) 1 C ROI Color CPD Color / 2 CPD CPD 3 ROI Position Size 4 4-4

4-3 Flow Sensitivity PRF Scale Invert Steering Wall Filter Variance Flow Low Flow Med Flow High PRF PRF PRF Scale Flow Sensitivity Steering -15 0 +15 WF Low WF Med WF High 4-5

M 0.5 1 5 Depth 3-11 Auto Gain 4-1 Gain CPD Color Gain (ROI) 1 Gain 2 Gain Gain 4-6

Freeze ( ) ( ) Cine Cine Freeze ( ) 2D Color 1 Zoom ROI 2 ROI 3 Zoom ROI 100% 4 5 Zoom Off 4-7

Steep Needle Profiling (SNP) FUJIFILM SonoSite CIVCO FUJIFILM SonoSite 8 4-4 SNP Steep Needle Profiling Steep Needle Profiling SNP Steep Needle Profiling SonoMBe 4-9 4-1 Steep Needle Profiling 4-9 4-2 SNP 2D 4-4 SNP C35x rc60xi / HFL38xi / HFL50x HSL25x 4-8

4-4 SNP L25x / L38xi / SNP 4-1 SNP 4-2 4-9

17 25 50 4-10 4-3 50 A B C Steep Needle Profiling Steep Needle Profiling 4-3 50 SNP Steep Needle Profiling L/R Flip / 4-1 Shallow Medium Steep Linear transducer 90 180 Curved array transducer 30 Shallow 30-40 Medium 40 Steep Off SNP SNP Steep Needle Profiling MB 4-10

Steep Needle Profiling 4-4 4-11

4-5 (Oph) FDA Oph 1 Transducer 2 Switch 4-12

Transducer Patient Information Exam Type 4-17 4-5 a 2D b CPD c Color c C8x C11x C35x rc60xi / 4-13

4-5 a 2D b CPD c Color c HFL38xi / HFL50x HSL25x ICTx 4-14

4-5 a 2D b CPD c Color c L25x / L38xi / P10x P11x d rp19x / 4-15

3-6 1 Label 2 Text 3 4 2-13 5 A B C 3-6 6 3 5 7 Done 1 Label 2 Arrow 3 4 5 Done 4-16

1 Label 2 Picto 3 X/X 4 5 6 U/L / D/L / D/R / U/R / 7 Done 5-20 1 Patient 2 End 3 4-19 2-13 4 Done 4-22 4-17

a USB ID USB Auto save Pat Form On 3-11 4-22 1 Patient 2 Information 3 2-13 4 Done Cancel 1 4-20 2 Patient 3 Information 4 End 4-18

Last First Middle ID Accession Date of birth Gender Indications User Procedure Worklist 1 Query Patient Information Exam Type 4-12 A-1 BP HR Height 1. DICOM DICOM 4-19

Weight BSA LMP Estab.DD LMP Estab.DD OB Gyn Reading Dr. Referring Dr. Institution Department ID Beep Alert 3-7 4-17 3-9 4-21 4-20

3-11 FUJIFILM SonoSite 1-2 1 Patient 2 Review List Select All USB Clear All USB 4-21

ID 1 2 Edit 3 Done 1 2 Append 1 2 Review 3 4 Play Pause Play 5 6 List 7 Done 4-22

1 USB 2 Patient Review 3 List Image Gallery 4 Select USB USB 5 USB Select 6 USB USB USB USB 1 3-8 2 1 3-8 2 4-23

USB USB 4-18 1 USB 2-7 USB 2 3 Exp.USB USB USB 4 USB Include patient information on images and clips USB 5 Export USB USB 6 Cancel Export 1 2 Delete DICOM SonoPHI PC DICOM SonoPHI SonoPHI DICOM 1 2 Archive 1 2 Info 4-24

6-1 5 M HR 5-3 5-1

1 Calipers 2 Ellipse Trace Delete 5-2

4-20 5-6 1 Calcs 2 5-7 3 5-7 5-3

5-1 1 Calipers A 2 3 cm 2 cm 1 Calipers 2 Ellipse 3 5-4

4 1 Calipers 2 Trace 3 4 5 Undo 6 Set M M / (HR)/ (bpm) 200 M 1 M Calipers 2 3 5-3 5-5

M 1 M Calipers 2 Heart Rate 3 4 5 Save Heart Rate 5-20 M M Add Caliper B C Heart Rate 5-20 5-6

5-20 (...) 1 Calcs Next Previous 2 3 4 Save Calc 5 Back Back Calipers Calcs Save Save Calc 5-7

5-20 1 2 Delete 5-20 1 Calcs 2 A 1 A 2 a Area Red b c Undo 5-8

d Set e Save Calc 1 Calcs 2 D 1 D 2 a Dia Red b c Save Calc 5-9

4-17 A-1 5-1 LVd LVs IVC Atria Ao/LA / RVW RVD IVS LVD LVPW RVW RVD IVS LVD LVPW D D LA A4C LA A2C RA Ao M AAo LA M LVOT D LVESV LVEDV IVSFT LVDFS LVPWFT LV M EF CO CI SV SI D D % LA A4C LA A2C LA RA Ao LA/Ao AAo LA LA/Ao LVOT D LVOT 5-10

5-1 MV EF:Slope M EPSS M EF EPSS Area AV AV LV mass LV EF TAPSE MV Epi Endo Apical LVDd LVDs TAPSE MV LV Epi Endo D Apical EF LVESV LVEDV LVDFS CO CI SV SI TAPSE Ao LA AAo LVOT D 1 M Calcs 2 Ao/LA / 3 Ao/LA / 4 5-1 5 Save Calcs 6 7 Back 5-11

MV AV 1 Calcs 2 Area 3 Area MV AV 4 5 Undo 6 Set 7 Save Calc 5-7 8 9 Back LV 1 Calcs 2 LV mass LV 3 EPI Endo a LV mass LV b c Undo 5-12

d Set e Save Calc 4 LV mass LV Apical 5 5-1 6 Save Calc 7 8 Back LVd LVs 1 M Calcs 2 LVd LVs 3 a LVd LVs b 5-1 c Save Calc 4 5 Back (IVC) 1 Calcs 2 IVC 5-13

3 D D a IVC b 5-1 c Save Calc 4 5 Back (EF) 1 M Calcs 2 EF 3 LVDd LVDs a EF b 5-1 c Save Calc 4 5 Back (TAPSE) 1 M Calcs 2 TAPSE 3 4 Save Calc 5 6 Back 5-14

MSK MSK 1 Calcs 2 Right Left a Hip Angle Baseline b A α Line A α c A B β Line B β d B β 1 Calcs 2 Right Left a d:d Ratio d:d Fem Hd b SELECT c SET d 5-15

(Gyn) (Gyn) 5-20 4-17 1 Calcs 2 a b 5-1 c Save Calc 3 4 Back 10 1 Calcs 2 Follicle 3 a Right Fol Left Fol b 5-1 c Save Calc 4 5 Back 5-16

EFW EDD EFW 5-17 4-17 A-1 3-11 5-17

5-2 a YS GS Hansmann, Nyberg, Tokyo U. CRL Hadlock, Hansmann, Osaka, Tokyo U. BPD Chitty, Hadlock, Hansmann, Osaka, Tokyo U. HC Chitty, Hadlock, Hansmann AC Hadlock, Hansmann, Tokyo U. FL Chitty, Hadlock, Hansmann, Osaka, Tokyo U. HL Jeanty Jeanty TCD CM Lat V CxLen a AUA b Tokyo U. APTD TTD EFW c (Estimated Fetal Weight) EFW 11 Hadlock EFW 1 2 3 5-18

5-2 (EFW) c HC AC FL Hadlock 1 BPD AC FL Hadlock 2 AC FL Hadlock 3 BPD Hansmann BPD, FL Osaka U. BPD AC BPD T TD APTD FL Shepard Tokyo U. Ratios HC/AC Campbell FL/AC FL/BPD FL/HC Hadlock Hohler Hadlock Q 1, Q 2, Q 3, Q 4 Jeng a AUA b Tokyo U. APTD TTD EFW c (Estimated Fetal Weight) EFW 11 Hadlock EFW 1 2 3 CxLen YS 1 OB LMP Estab.DD 2 Calcs 5-19

3 a b 5-1 c Save Calc 4 5 Back M 1 M Calcs 2 FHR 3 4 5 Save Calc 6 7 Back (###) A-1 5-20

1 Patient Report 2 x/x 3 Done Save 1 2 Delete 1 Details Details 2 3 Delete RA Summary RA RA 5 RVSP MSK MSK MSK MSK 1 Patient MSK 2 Worksheet 5-21

3 x/x Comments 4 Save 5 MSK Done 5-22

6 10 10 6-1

6-1 2D a b (cm) < ±2% + 1% 0-26 cm < ±2% + 1% 0-35 cm < ±2% + 1% 0-44 cm c < ±4% + ( 2%/) * 100 + 0.5% 0.01-720 cm 2 d < ±3% + ( 1.4%/) * 100 + 0.5% 0.01-96 cm a b 0.7 db/cm MHz RMI 413a c % = ((1 + ) * (1 + ) - 1) * 100 + 0.5% d % = ( 2 (2 ) * 100) + 0.5% AIUM 6-2

(BSA) m 2 Grossman, W. Cardiac Catheterization and Angiography. Philadelphia: Lea and Febiger, (1980), 90. BSA = 0.007184 * 0.425 * 0.725 = = (CI) l/min/m 2 Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition., Philadelphia: Lippincott, Williams, and Wilkins, (2007), 69-70. CI = CO/BSA CO = BSA = (CO) l/min Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition., Philadelphia: Lippincott, Williams, and Wilkins, (2007), 69-70. CO = (SV * HR)/1000 CO = SV = (ml) HR = (CSA) cm 2 Oh, J. K., J. B. Seward, and A. J. Tajik. The Echo Manual. 3rd Edition. Philadelphia: Lippincott Williams and Wilkins,(2007), 70-71. CSA = 0.785 * D 2 D = 6-3

(EF) Oh, J. K., J. B. Seward, & A. J. Tajik. The Echo Manual. 3rd ed. Philadelphia: Lippincott Williams & Wilkins, (2007), 115-116. EF = ((LVEDV - LVESV)/LVEDV) * 100% EF = LVEDV = LVESV = (HR) bpm HR = M 3 (IVS) Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71. IVSFT = ((IVSS - IVSD)/IVSD) * 100% IVSS = IVSD = / (LA/Ao) Feigenbaum, H. Echocardiography. Philadelphia: Lea and Febiger, (1994), 206, Figure 4-49. Lang R. et al. "Recommendations for Cardiac Chamber Quantification: A report from the American Society of Echocardiography s Guidelines and Standards Committee and the Chamber Quantification Writing Group, Developed in Conjunction with the European Association of Echocardiography, a Branch of the European Society of Cardiology." J Am Soc Echocardiography. (2005), 18:1440-1463. Lang R, Bierig M, Devereux R, et al. "Recommendations for Cardiac chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging." J Am Soc Echocardiography (2015), 28:1-39. LA Vol = π/4(h) Σ(D1)(D2) LA Vol = ml h = LA D1 = D2 = 6-4

2 Simpson LA Vol = p/4(h) Σ(D1)(D2) Simpson LA h D1 D2 1 Simpson LA Vol =p/4(h) Σ(D1) 2 2 LA Vol Index LA Vol Index = LA Vol/BSA (Teichholz) ml Teichholz, L.E., T. Kreulen, M.V. Herman, et. al. "Problems in echocardiographic volume determinations: echocardiographic-angiographic correlations in the presence or absence of asynergy." American Journal of Cardiology, (1976), 37:7. LVESV = (7.0 * LVDS 3 )/(2.4 + LVDS) LVESV = LVDS = LVEDV = (7.0 * LVDD 3 )/(2.4 + LVDD) LVEDV = LVDD = gm Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott Williams and Wilkins, (2007), 113-114. LV = 1.04 [(LVID + PWT + IVST) 3 - LVID 3 ] * 0.8 + 0.6 LVID = PWT = IVST = 1.04 = 0.8 = 6-5

gm Schiller, N.B., P.M. Shah, M. Crawford, et.al. "Recommendations for Quantification of the Left Ventricle by Two-Dimensional Echocardiography." Journal of American Society of Echocardiography. September-October 1998, 2:364. LV = 1.05 * {[(5/6) * A1 * (a + d + t)] - [(5/6) * A2 * (a + d)]} A1 = (Epi) A2 = (Endo) a = d = t = ml Schiller, N.B., P.M. Shah, M. Crawford, et.al. "Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography." Journal of American Society of Echocardiography. September-October 1989, 2:362. π V = -- 4 n i = 1 L a i b i -- n V = ml ai = i mm bi = i mm n = (n=20) L = i = 6-6

ml Schiller, N.B., P.M. Shah, M. Crawford, et.al. "Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography." Journal of American Society of Echocardiography. September-October 1989, 2:362. π V = -- 4 n i = 1 2 L a i -- n V = ai = i mm n = (n=20) L = i = (LVD) Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott Williams and Wilkins, (2007), 115. LVDFS = ((LVDD - LVDS)/LVDD) * 100% LVDD = LVDS = (LVPWFT) Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71. LVPWFT = ((LVPWS - LVPWD)/LVPWD) * 100% LVPWS = LVPWD = (SI) cc/m 2 Mosby's Medical, Nursing, & Allied Health Dictionary, 4th ed., (1994), 1492. SI = SV/BSA SV = BSA = 6-7

M (SV) ml Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company, (1994), 44. SV = (LVEDV - LVESV) SV = LVEDV = LVESV = (AFI) Jeng, C. J., et al. "Amniotic Fluid Index Measurement with the Four Quadrant Technique During Pregnancy." The Journal of Reproductive Medicine, 35:7 (July 1990), 674-677. (AUA) AUA (AUA) (EDD) / / EDD = + (280 - AUA ) (LMP) (EDD) LMP / / EDD = LMP + 280 6-8

(EFW) Hadlock, F., et al. "Estimation of Fetal Weight with the Use of Head, Body, and Femur Measurements, A Prospective Study." American Journal of Obstetrics and Gynecology, 151:3 (February 1, 1985), 333-337. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 154. Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 103-105. Shepard M.J., V. A. Richards, R. L. Berkowitz, et al. "An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound." American Journal of Obstetrics and Gynecology, 142:1 (January 1, 1982), 47-54. University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1. (LMP) (GA) LMP GA(LMP) = - LMP (Estab.DD) (LMPd) (GA) (Estab.DD) (GA) LMP GA(LMPd) = - LMPd (Estab.DD) (LMPd) / / LMPd(Estab.DD) = Estab.DD - 280 6-9

(AC) Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 431. University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. FUJIFILM SonoSite 20.0 cm 30.0 cm (AC) AC AC (APTD) University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. (BPD) Chitty, L. S. and D.G. Altman. "New charts for ultrasound dating of pregnancy." Ultrasound in Obstetrics and Gynecology 10: (1997), 174-179, Table 3. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 440. Osaka University. Ultrasound in Obstetrics and Gynecology.(July 20, 1990), 98. University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. 6-10

(CRL) Hadlock, F., et al. "Fetal Crown-Rump Length: Re-evaluation of Relation to Menstrual Age (5-18 weeks) with High-Resolution, Real-Time Ultrasound." Radiology, 182: (February 1992), 501-505. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 439. Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 20 and 96. Tokyo University. "Gestational Weeks and Computation Methods." Ultrasound Imaging Diagnostics, 12:1 (1982-1), 24-25, Table 3. (FL) Chitty, L. S. and D.G. Altman. "New charts for ultrasound dating of pregnancy." Ultrasound in Obstetrics and Gynecology 10: (1997), 174-179, Table 8, 186. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 431. Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101-102. University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 886. (FTA) Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99-100. (GS) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985). Nyberg, D.A., et al. "Transvaginal Ultrasound." Mosby Yearbook, (1992), 76. Nyberg Tokyo University. "Gestational Weeks and Computation Methods." Ultrasound Imaging Diagnostics, 12:1 (1982-1). 6-11

(HC) Chitty, L. S. and D.G. Altman. "New charts for ultrasound dating of pregnancy." Ultrasound in Obstetrics and Gynecology 10: (1997), 174-191, Table 5, 182. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 431. (HL) Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. "Estimate of Gestational Age from Measurements of Fetal Long Bones." Journal of Ultrasound in Medicine.3: (February 1984), 75-79 (OFD) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 431. Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. "Estimate of Gestational Age from Measurements of Fetal Long Bones." Journal of Ultrasound in Medicine. 3: (February 1984), 75-79 (TTD) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1985), 431. University of Tokyo, Shinozuka, N. FJSUM, et al. "Standard Values of Ultrasonographic Fetal Biometry." Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. FL/AC Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, and S.K. Park. "A Date Independent Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference Ratio," American Journal of Roentgenology, 141: (November 1983), 979-984. 6-12

FL/BPD Hohler, C.W., and T.A. Quetel. "Comparison of Ultrasound Femur Length and Biparietal Diameter in Late Pregnancy," American Journal of Obstetrics and Gynecology, 141:7 (Dec. 1 1981), 759-762. FL/HC Hadlock F.P., R. B. Harrist, Y. Shah, and S. K. Park. "The Femur Length/Head Circumference Relation in Obstetric Sonography." Journal of Ultrasound in Medicine, 3: (October 1984), 439-442. HC/AC Campbell S., Thoms Alison. "Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation," British Journal of Obstetrics and Gynaecology, 84: (March 1977), 165-174. (Vol) Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131. 6-13

6-14

7 FUJIFILM SonoSite 1-2 1 2 10 3 1 LCD 2 3 CPD Color OB OB 7-1

1 Connectivity 3-8 2 3 C: FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 1-2 3-12 7-2

7-1 ARM PCBA PCBA 1 2 Enter license number 3 Done FUJIFILM SonoSite 1-2 4 Done SonoSite SII FUJIFILM SonoSite 1-2 7-3

8-1 FUJIFILM SonoSite www.sonosite.com 7-4

FUJIFILM SonoSite 2-1 8 www.sonosite.com/transducers (PPE) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 8-1

FUJIFILM SonoSite (FDA) 8-1 8-1 8-3 A B 8-8 Spaulding Spaulding Spaulding 8-1 8-2

A (PPE) FUJIFILM SonoSite 8-3

1 2 3 4 5 a 8-2/ / a SaniCloth AF3 b SaniCloth Plus PI-Spray II 3 3 10 a b www.sonosite.com b c d e 8-4

6 SonoSite SII 7 a 8-3 a b Sani-Cloth AF3 c C8x, C11x, C35x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, P10x, P11x d, rc60xi, rp19x 3 Sani-Cloth Plus HFL50x, L52x e 3 PI-Spray II C8x, C11x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, L52x e, P10x, P11x d, rc60xi, rp19x 10 a b c d P11x e L52x www.sonosite.com b c d 8-5

8 5 6 7 9 10 a 8-4 a Cidex Cidex OPA C8x, C11x, C35x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, P10x, P11x b, rc60xi, rp19x C8x, C11x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, L52x c, P10x, rc60xi, rp19x 25 o C 45 20 o C 12 Revital-OX Resert C35x 20 o C 8 a b P11x c L52x www.sonosite.com b c d 11 a FUJIFILM SonoSite 8-6

b 5 cm 5 cm 8-1 12 a 1 b 31 46 cm c 13 14 15 FUJIFILM SonoSite 8-7

B A 8-3 (PPE) FUJIFILM SonoSite 1 2 3 4 8-8

5 a 8-5/ / a SaniCloth AF3 b SaniCloth Plus PI-Spray II 3 3 10 a b www.sonosite.com b c d 6 SonoSite SII 7 a 8-6/ a b Sani-Cloth AF3 c C8x, C11x, C35x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, P10x, P11x d, rc60xi, rp19x 3 Sani-Cloth Plus HFL50x, L52x e 3 PI-Spray II C8x, C11x, HFL38xi, HFL50x, HSL25x, ICTx, L25x, L38xi, L52x e, P10x, P11x d, rc60xi, rp19x 10 a b c d P11x e L52x www.sonosite.com 8-9

b c d 8 5 6 7 9 10 FUJIFILM SonoSite 1 2 x 0 o C +45 o C 8-10

1 ISO 2 1 2 8-11

FUJIFILM SonoSite FUJIFILM SonoSite 1 2-35 o C +65 o C SonoSite SII www.sonosite.com 1 2 3 www.sonosite.com 4 8-12

9 a,b,c (MSD) MSD MSD a. Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. "Work-related Musculoskeletal Complaints in Sonologists." Occupational Environmental Medicine. 41:11 (1999), 981-988. b. Craig, M. "Sonography: An Occupational Health Hazard?"Journal of Diagnostic Medical Sonography. 3 (1985), 121-125. c. Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. "Musculoskeletal Pain in Cardiac Ultrasonographers: Results of a Random Survey." Journal of American Society of Echocardiography. (May1997), 357-362. 9-1

MSD MSD a MSD b,c a. Wihlidal, L.M. and S. Kumar. "An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta." International Journal of Industrial Ergonomics.19 (1997), 205-216. b. Habes, D.J. and S. Baron. "Health Hazard Report 99-0093-2749." University of Medicine and Dentistry of New Jersey. (1999). c. Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. "Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers." Journal of Medicine. 35:6 (1993), 605-610. 9-2

MSD MSD 9-3

I BF IPX-7 I I I IPX-8 AP/APG SonoSite SII EN60601-1 Class I I / Type BF BF 9-23 9-4

Hospital Only Hospital Grade / (MPSO) SonoSite SII 7-1 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite SonoSite SII / VGA FUJIFILM SonoSite 9-5

7-1 / 0 40 C 60 C 2 6 FUJIFILM SonoSite 1-2 9-6

FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 21 CFR 801.437 ALARA MI TI FUJIFILM SonoSite 0.3 db/cm/mhz P10x rp19x P10x rp19x 9-7

IEC 60601-1-2:2001 (EMC) s FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 9-11 EMC RF (EMI) EMI EMI EMI EMI EMI EMI EMI IEC 60601-1-2 EMC 9-8

SonoSite SII IEEE 802.11 2.412 2.484GHz ISM IEEE 802.11b 16 db (CCK) (DQPSK) (DBPSK) IEEE 802.11g 13 dbm (ODFM) (ESD) ESD ESD ESD ESD ESD 1 ESD ESD ESD ESD IEC 60601-1-2 5.2.1.2 d 9-9

SonoSite SII (RF) SonoSite SII RF SonoSite SII 9-1 RF SonoSite SII 150 khz 80 MHz d=1.2 P 80 MHz 800 MHz d=1.2 P 800 MHz 2.5 GHz d=2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 (d) P (W) 80 MHz 800 MHz 9-10

FUJIFILM SonoSite SonoSite SII IEC60601-1-2:2007 FUJIFILM SonoSite SonoSite SII SonoSite SII 9-2 SonoSite SII C8x C11x C35x rc60xi / HFL38xi / HFL50x HSL25x ICTx L25x / L38xi / L52x P10x P11x rp19x / 1.8 m 1.8 m 1.7 m 1.7 m 1.7 m 1.7 m 2.4 m 1.7 m 2.4 m 1.7 m 2.4 m 1.8 m 2.0 m 1.8 m 1.5 m PowerPack PowerPack 9-11

9-2 SonoSite SII 1 m 1.8 m 1.9 m 3 m SonoSite SII 3 m 2 m 1 m PowerPark USB USB EMC 9-3 - ClSPR 11 1 SonoSite SII RF 9-12

9-3 - ClSPR 11 IEC 61000-3-2 / IEC 61000-3-3 A A SonoSite SII 9-4 - IEC 60601 (ESD) IEC 61000-4-2 ± 2.0 KV ± 4.0 KV ± 6.0 KV ± 2.0 KV ± 4.0 KV ± 8.0 KV ± 2.0 KV ± 4.0 KV ± 6.0 KV ± 2.0 KV ± 4.0 KV ± 8.0 KV 30% IEC 61000-4-4 ± 2 KV ± 1 KV ± 2 KV ± 1 KV IEC 61000-4-5 ±1 KV ± 2 KV ±1 KV ± 2 KV a. / FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3 V/m 9-13

9-4 - IEC 60601 IEC 61000-4-11 <5% U T U T >95% 0.5 40% U T U T 60% 5 70% U T U T 30% 25 <5% U T U T >95% 5 <5% U T U T >95% 0.5 40% U T U T 60% 5 70% U T U T 30% 25 <5% U T U T >95% 5 FUJIFILM SonoSite FUJIFILM SonoSite IEC 61000-4-8 RF IEC 61000-4-6 3 V/m 3 V/m FUJIFILM SonoSite 3 Vrms 150 khz 80 MHz 3 Vrms FUJIFILM SonoSite RF d = 1.2 P a. / FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3 V/m 9-14

9-4 - IEC 60601 IEC 61000-4-3 3 V/m 80 MHz 2.5 GHz 3 V/m a b IEC 60417 No. 417-IEC-5140 U T 80 MHz 800 MHz a. / FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3 V/m 15 15 9-15

SonoSite SII IEC 60601-1-2 IEC 60601-2-37 SonoSite SII 9-5 (AC) 1 93/42/EEC VII 1 IIa IIb III 93/42/EEC 9-16

9-5 LOT "C" "US" CSA ANSI/UL REF 93/86/EEC STERILE EO (DC) 9-17

9-5 # # FCC GEL STERILE R SN 9-18

9-5 SonoSite SII BF B = F = RoHS / / CCC 9-19

9-5 44.7 cm 151 cm 124.5 cm 28.7 cm 12.2 cm 5.7 kg 26.1 kg 9-20

9-6 C11x rc60xi / HFL38xi / HFL50x HSL25x ICTx L25x L38xi / L52x P10x P11x rp19x / 1.8 m 1.7 m 1.7 m 1.7 m 2.4 m 1.7 m 2.3 m 1.7 m 2.4 m 1.8 m 2.0 m 1.8 m 256 (CPD) 256 (Color) 256 M (THI) 9-21

PDAS Image Manager (3.1 m) EN60601-1 USB Sony www.sony.com/digitalphotofinishing Kensington 10 40 C 15 95% 700 1060 hpa 0.7 1.05 ATM -35 65 C 15 95% 500 1060 hpa 0.5 1.05 9-22

-20 60 C 15 95% R.H. 30 500 1060 hpa (0.5 1.05 ATM) 100 240 VAC 50/60 Hz 2.0 1.0 A #1 15.0 VDC 5.0 A #2 9 12.6 VDC 2.3 A 75 W 9-7 ANSI/AAMI ES60601-1:2005/(R) 2012 A1:2012 CAN/CSA C22.2 No. 60601-1:2014 3.1 IEC 60601-1:2012 3.1 IEC 60601-2-37:2007 IEC 60601-1-6:2013 JIS T0601-1:2012 1 3.1-1 3-1 - 1 3-1 - 2-37 2-37 1-6 - 9-23

EMC 9-8 EMC IEC 60601-1-2:2007 CISPR 11:2009 - (ISM) - 1 A AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing (2009) AAMI/ANSI/ISO 10993-1:2009-1 (2009) AAMI/ANSI/ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity (2009) AAMI/ANSI/ISO 10993-5 - 5 In Vitro (2009) AAMI/ANSI/ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (2014) AAMI/ANSI/ISO 10993-10 - 10 (2002) AAMI/ANSI/ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity (2006) AAMI/ANSI/ISO 10993-11 11 (2006) AAMI/ANSI/ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials (2012) AAMI/ANSI/ISO 10993-12 12 (2012) RTCA DO-160E, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118 21.0 B.118 DICOM DICOM SonoSite Edge II SonoSite SII DICOM www.sonosite.com 9-24

HIPAA HIPAA The Health Insurance Portability and Accountability Act, Pub.L.No. 104-191 (1996). 1996 104-19145 CFR 160, General Administrative Requirements 45 CFR 160 45 CFR 164, Security and Privacy 45 CFR 164 9-25

9-26

ALARA 10 ALARA ALARA ALARA ALARA ALARA 2D CPD Color (THI) 2D ALARA 10-1

EN 60601-2-37 42 10-9 3 (ISPTA) 720 mw/cm 2 ISPTA 50 mw/cm 2 TI 1.0 MI 0.23 (MI) (TI) 1.0 MI TI 10-3 MI TI ALARA MI TI MI TI BS EN 60601-2-37:2001 HH PRF 10-2

Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). MI TI MI TI MI TI MI TI MI TI P11x MI TI P11x P11x 10-1 MI C8x C11x C35x rc60xi / HFL38xi / HFL50x HSL25x MI MI 10-3

10-1 MI ICTx L25x / L38xi / P10x rp19x / MI MI 10-2 TI PRF C8x C11x C35x rc60xi / TI TI 10-4

10-2 TI PRF HFL38xi / HFL50x HSL25x ICTx L25x / L38xi / P10x rp19x / TI TI 10-5

MI TI AIUM 10-8 10-3 TI MI 1.0 10-3 TI MI 1.0 2D/M CPD/ C8x MI TIC TIB TIS C11x/8-5 MI TIC TIB TIS C35x MI TIC TIB TIS rc60xi/5-2 / MI TIC TIB TIS HFL38xi/13-6 / MI TIC TIB TIS HFL50x/15-6 MI TIC TIB TIS HSL25x/13-6 MI TIC TIB TIS ICTx/8-5 MI TIC TIB TIS L25x/13-6 / MI TIC TIB TIS MI 1.0 0.1 MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI 8 10-6

10-3 TI MI 1.0 2D/M CPD/ L38xi/10-5 / MI TIC TIB TIS P10x/8-4 MI TIC TIB TIS rp19x/5-1 / MI TIC TIB TIS MI 1.0 0.1 MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI 8 P11x P11x P11x P11x MI 95% 95% MI MI +18% -25% +0.2 TI 95% 95% TI TI +21% -40% +0.2 +1 db -3 db MI TI 0.0 0.05 10-7

10-47 MI TI / / Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 2008. Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004. Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD3-2004. Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN 60601-2-37 reprinted at P05699. 10-8

10-4 10-5 (23 C ± 3 C) EN 60601-2-37 42 P11x P11x P11x P11x 10-4 ( C) C11x C35x rc60xi HFL38xi HFL50x HSL25x L25x L38xi P10x rp19x 14.2 15.3 15.0 12.4 10.7 17.5 16.1 12.5 16.0 14.9 7.3 8.5 8.9 7.7 7.7 9.1 8.5 8.8 9.1 7.6 10-5 ( C) C8x ICTx 11.3 9.2 5.5 5.2 1987 10 (AIUM) - Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement) Stowe (Stowe Report) 1993 1 28 (Bioeffects and Safety of Diagnostic Ultrasound) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment(NEMA UD2-2004) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (NEMA UDe3-2004) 10-9

= [e -(0.23alf) ] = = e = 2.7183 a = (db/cm MHz) = 0.53 = 0.66 = 0.79 = 0.43 = 0.55 l = f = / / MHz 0.3 = [e -(0.069lf) ] 10-10

0.3 db/cm MHz 3 1dB/cmMHz 1990 MI 0.1 1.0 MI 2.0 M MI 1988 1990 1 4 C 1.5 C 7 C I SPTA 500 mw/cm 2 Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) 4.3.2.1-4.3.2.6 10-6 10-38 TI MI 1.0 10-46 * P11x P11x P11x P11x C8x... 13 C8x CPD/... 14 C8x M Mode... 15 10-11

C35x... 16 rc60xi /... 17 rc60xi / CPD/... 18 rc60xi / M... 19 HFL38xi /... 20 HFL38xi / M... 21 HFL38xi / CPD/... 22 HFL38xi... 23 HFL38xi M... 24 HFL38xi M... 25 HFL50x... 26 HFL50x M Mode... 27 HFL50x CPD/... 28 HSL25x... 29 HSL25x CPD/... 30 HSL25x... 31 HSL25x M... 32 HSL25x CPD/... 33 L25x /... 34 L25x / CPD/... 35 L25x... 36 L25x M... 37 L25x CPD/... 38 L38xi /... 39 L38xi / M... 40 L38xi / CPD/... 41 P10x CPD/... 42 rp19x /... 43 rp19x / M... 44 rp19x / CPD/... 45 10-12

10-6 C8x M.I. TIS A aprt <1 A aprt >1 TIB 1.1 (a) (b) p r.3 (MPa) 2.48 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.2 d eq (Z sp ) (cm) F c (MHz) 5.53 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.239 PRF (Hz) 9524 p r @PII max (MPa) 3.11 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 264 1 2 3 2.5 3.2 4 MB (a) <1 (b) # - / TIC 10-13

10-7 C8x M.I. CPD/ TIS A aprt <1 A aprt >1 TIB 1.4 (a) (b) p r.3 (MPa) 3.18 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 4.82 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.694 PRF (Hz) 2548 p r @PII max (MPa) 3.63 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 555 1 2 CVD 3 2D / / 1.5-1.9 4/ / 5 / / (a) <1 (b) # - / TIC 10-14

10-8 C8x M.I. M Mode TIS A aprt <1 A aprt >1 TIB 1.4 (a) (a) (b) p r.3 (MPa) 3.16 W 0 (mw) # # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.1 # d eq (Z sp ) (cm) # F c (MHz) 5.07 # # # A aprt X (cm) # # # Y (cm) # # # PD (μsec) 0.427 PRF (Hz) 800 p r @PII max (MPa) 3.83 d eq @Pll max (cm) # FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 482 1 2 3 4.2 (a) <1 (b) # - / TIC 10-15

10-9 C35x M.I. TIS A aprt <1 A aprt >1 TIB 1.0 (a) (b) p r.3 (MPa) 1.8 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 3.3 d eq (Z sp ) (cm) F c (MHz) 3.4 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 1.111 PRF (Hz) 1021 p r @PII max (MPa) 2.61 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 250 1 2 3 4 MB 5 8.3 cm N/A (a) <1 (b) # - / TIC 10-16

10-10 rc60xi / M.I. TIS A aprt <1 A aprt >1 TIB 1.5 (a) (b) p r.3 (MPa) 2.31 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 4.3 d eq (Z sp ) (cm) F c (MHz) 2.36 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.680 PRF (Hz) 3584 p r @PII max (MPa) 3.29 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 356 FL y (cm) # # 1 2 3 11 cm 4 MB 5 THI (a) <1 (b) # - / TIC 10-17

10-11 rc60xi / M.I. CPD/ TIS A aprt <1 A aprt >1 TIB 1.5 1.2 (b) p r.3 (MPa) 2.21 W 0 (mw) 107.5 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 4.3 d eq (Z sp ) (cm) F c (MHz) 2.22 2.21 # A aprt X (cm) 0.66 # Y (cm) 1.20 # PD (μsec) 0.729 PRF (Hz) 1265 p r @PII max (MPa) 3.07 d eq @Pll max (cm) # FL x (cm) 2.50 # I PA.3 @MI max (W/cm 2 ) 342 FL y (cm) 6.50 # 1 2 CVD CVD 3 2D //THI 4/ 5 / / 11 cm/ /342 / - / 4.7 cm/ /3125 / - (a) <1 (b) # - / TIC 10-18

10-12 rc60xi / M.I. M TIS A aprt <1 A aprt >1 TIB 1.3 (a) 1.0 (b) p r.3 (MPa) 2.18 W 0 (mw) 69.8 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 4.20 z@pii.3max (cm) 4.3 d eq (Z sp ) (cm) 0.69 F c (MHz) 2.66 # 2.89 # A aprt X (cm) # 2.25 # Y (cm) # 1.20 # PD (μsec) 0.620 PRF (Hz) 800 p r @PII max (MPa) 3.25 d eq @Pll max (cm) 0.49 FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 290 FL y (cm) # # 1 2 3 6.6 cm 9.2 cm 4 THI (a) <1 (b) # - / TIC 10-19

10-13 HFL38xi / MI TIS A aprt <1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 3.05 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 1.2 d eq (Z sp ) (cm) F c (cm) 5.36 # # z bp (MHz) # # A aprt X (cm) # # Y (cm) PD (μsec) 0.521 PRF (Hz) 2127 p r @PII max (MPa) 3.81 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 494 FL y (cm) # # 1 2 3 3.3 cm 4 MB N/A 5 (a) <1 (b) # / TIC 10-20

10-14 HFL38xi / MI M TIS A aprt <1 A aprt >1 TIB 1.2 (a) (a) (b) p r.3 (MPa) 3.14 W 0 (mw) # # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) # z@pii.3max (cm) 1.4 d eq (Z sp ) (cm) # F c (cm) 6.75 # # # z bp (MHz) # # # A aprt X (cm) # # # Y (cm) PD (μsec) 0.263 PRF (Hz) 1600 p r @PII max (MPa) 4.35 d eq @Pll max (cm) # FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 388 1 2 3 FL y (cm) # # 4.0 cm (a) <1 (b) # / TIC 10-21

10-15 HFL38xi / MI CPD/ TIS A aprt <1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 3.05 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 1.2 d eq (Z sp ) (cm) F c (MHz) 5.36 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.521 PRF (Hz) 2223 p r @PII max (MPa) 3.81 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 494 1 2 3 2D / 4// 5 / FL y (cm) # # CVD / 3.3 cm /401 / (a) <1 (b) # - / TIC 10-22

10-16 HFL38xi M.I. TIS A aprt <1 A aprt >1 TIB 0.17 0.01 (b) p r.3 (MPa) 0.43 W 0 (mw) 0.21 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 2.1 d eq (Z sp ) (cm) F c (MHz) 6.59 6.75 # A aprt X (cm) 0.88 # Y (cm) 0.40 # PD (μsec) 0.117 PRF (Hz) 11339 p r @PII max (MPa) 0.70 d eq @Pll max (cm) FL x (cm) 2.65 # FL y (cm) 2.44 # I PA.3 @MI max (W/cm 2 ) 11.4 1 2 3 4.9 cm 4.9 cm 4 MB (a) <1 (b) # - / TIC 10-23

10-17 HFL38xi M.I. M TIS A aprt <1 A aprt >1 TIB 0.17 0.01 0.01 (b) p r.3 (MPa) 0.44 W 0 (mw) 0.087 0.064 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.10 z@pii.3max (cm) 1.0 d eq (Z sp ) (cm) 0.12 F c (MHz) 6.58 6.86 6.78 # A aprt X (cm) 0.68 0.44 # Y (cm) 0.40 0.40 # PD (μsec) 0.123 PRF (Hz) 800 p r @PII max (MPa) 0.55 d eq @Pll max (cm) 0.12 FL x (cm) 2.00 # FL y (cm) 2.44 # I PA.3 @MI max (W/cm 2 ) 10.3 1 2 3 1.5 cm 6.0 cm 4.0 cm (a) <1 (b) # - / TIC 10-24

10-18 HFL38xi M.I. M TIS A aprt <1 A aprt >1 TIB 0.17 0.02 (b) p r.3 (MPa) 0.39 W 0 (mw) 0.75 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.9 d eq (Z sp ) (cm) F c (MHz) 5.34 5.37 # A aprt X (cm) 0.76 # Y (cm) 0.40 # PD (μsec) 0.533 PRF (Hz) 4537 p r @PII max (MPa) 0.46 d eq @Pll max (cm) FL x (cm) 2.65 # FL y (cm) 2.44 # I PA.3 @MI max (W/cm 2 ) 5.5 1 2 CVD CVD 3 2D / / 1.5 cm / 4.9 cm 4/ /7813 / 6944 5 / / / (a) <1 (b) # - / TIC 10-25

10-19 HFL50x MI TIS A aprt <1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 3.051 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 1.2 d eq (Z sp ) (cm) F c (MHz) 5.36 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.521 PRF (Hz) 2733 p r @PII max (MPa) 3.81 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 493 FL y (cm) # # 1 2 3 3.3 4 MBe (a) <1 (b) # - / TIC 10-26

10-20 HFL50x M.I. M Mode TIS A aprt <1 A aprt >1 TIB 1.2 (a) (a) (b) p r.3 (MPa) 3.14 W 0 (mw) # # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.4 # d eq (Z sp ) (cm) # F c (MHz) 6.75 # # # A aprt X (cm) # # # Y (cm) # # # PD (μsec) 0.263 PRF (Hz) 1600 p r @PII max (MPa) 4.35 d eq @Pll max (cm) # FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 388 FL y (cm) # # 1 2 3 4.0 (a) <1 (b) # - / TIC 10-27

10-21 HFL50x CPD/ M.I. TIS A aprt <1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 3.05 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.2 d eq (Z sp ) (cm) F c (MHz) 5.36 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.521 PRF (Hz) 8233 p r @PII max (MPa) 3.81 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 494 1 2 3/ 4 FL y (cm) # # /3.3 (a) <1 (b) # - / TIC 10-28

10-22 HSL25x M.I. TIS A aprt <1 A aprt >1 TIB 1.2 (a) (b) p r.3 (MPa) 2.87 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 6.11 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.630 PRF (Hz) 1061 p r @PII max (MPa) 3.39 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 478 FL y (cm) # # 1 / / / 2 3 1.9 2.2 4 MBe (a) <1 (b) # - / TIC 10-29

10-23 HSL25x CPD/ M.I. TIS A aprt <1 A aprt >1 TIB 1.0 (a) (b) p r.3 (MPa) 2.35 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 6.11 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.630 PRF (Hz) 3079 p r @PII max (MPa) 2.78 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 276 1 2 3 2D / 4// 5 / FL y (cm) # # CVD / 3.1 cm /401 / (a) <1 (b) # - / TIC 10-30

10-24 HSL25x M.I. TIS A aprt <1 A aprt >1 TIB 0.17 0.02 (b) p r.3 (MPa) 0.47 W 0 (mw) 0.70 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 7.65 6.97 # A aprt X (cm) 0.96 # Y (cm) 0.30 # PD (μsec) 0.101 PRF (Hz) 12580 p r @PII max (MPa) 0.58 d eq @Pll max (cm) FL x (cm) 3.80 # I PA.3 @MI max (W/cm 2 ) 13.4 FL y (cm) 2.70 # 1 2 3 1.9 cm 4.3 cm 4 MB (a) <1 (b) # - / TIC 10-31

10-25 HSL25x M.I. M TIS A aprt <1 A aprt >1 TIB 0.17 0.01 0.02 (b) p r.3 (MPa) 0.47 W 0 (mw) 0.45 0.45 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.85 z@pii.3max (cm) 1.0 d eq (Z sp ) (cm) 0.35 F c (MHz) 7.59 6.25 6.25 # A aprt X (cm) 0.96 0.96 # Y (cm) 0.30 0.30 # PD (μsec) 0.098 PRF (Hz) 1600 p r @PII max (MPa) 0.61 d eq @Pll max (cm) 0.27 FL x (cm) 3.80 # I PA.3 @MI max (W/cm 2 ) 14.9 FL y (cm) 2.70 # 1 2 3 1.9 cm 4.3 cm 4.3 cm (a) <1 (b) # - / TIC 10-32

10-26 HSL25x M.I. CPD/ TIS A aprt <1 A aprt >1 TIB 0.17 0.06 (b) p r.3 (MPa) 0.42 W 0 (mw) 1.9 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.7 d eq (Z sp ) (cm) F c (MHz) 6.11 6.10 # A aprt X (cm) 0.52 # Y (cm) 0.30 # PD (μsec) 0.628 PRF (Hz) 3096 p r @PII max (MPa) 0.49 d eq @Pll max (cm) FL x (cm) 2.80 # I PA.3 @MI max (W/cm 2 ) 7.5 FL y (cm) 2.70 # 1 2 CVD CVD 3 2D / / 1.9 cm / 5.1 cm 4/ /401 /4167 5 / / / - (a) <1 (b) # - / TIC 10-33

10-27 L25x / M.I. TIS A aprt 1 A aprt >1 TIB 1.2 (a) (b) p r.3 (MPa) 2.87 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 6.11 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.630 PRF (Hz) 1061 p r @PII max (MPa) 3.39 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 478 FL y (cm) # # 1 / / / 2 3 1.9 2.2 4 MBe (a) <1 (b) # - / TIC 10-34

10-28 L25x / CPD/ M.I. TIS A aprt <1 A aprt >1 TIB 1.0 (a) (b) p r.3 (MPa) 2.35 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 6.11 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.630 PRF (Hz) 5261 p r @PII max (MPa) 2.78 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 276 1 2 3 2D / 4/ 5 / FL y (cm) # # CVD / 3.1 cm /779 / (a) <1 (b) # - / TIC 10-35

10-29 L25x M.I. TIS A aprt <1 A aprt >1 TIB 0.17 0.02 (b) p r.3 (MPa) 0.47 W 0 (mw) 0.70 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max 0.8 d eq (Z sp ) (cm) F c (MHz) 7.65 6.97 # A aprt X (cm) 0.96 # Y (cm) 0.30 # PD (μsec) 0.101 PRF (Hz) 12580 p r @PII max (MPa) 0.58 d eq @Pll max (cm) FL x (cm) 3.80 # I PA.3 @MI max (W/cm 2 ) 13.4 FL y (cm) 2.70 # 1 2 3 1.9 cm 4.3 cm 4 MB (a) <1 (b) # - / TIC 10-36

10-30 L25x M.I. M TIS A aprt <1 A aprt >1 TIB 0.17 0.01 0.02 (b) p r.3 (MPa) 0.47 W 0 (mw) 0.45 0.45 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.85 z@pii.3max (cm) 1.0 d eq (Z sp ) (cm) 0.35 F c (MHz) 7.59 6.25 6.25 # A aprt X (cm) 0.96 0.96 # Y (cm) 0.30 0.30 # PD (μsec) 0.098 PRF (Hz) 1600 p r @PII max (MPa) 0.61 d eq @Pll max (cm) 0.27 FL x (cm) 3.80 # I PA.3 @MI max (W/cm 2 ) 14.9 FL y (cm) 2.70 # 1 2 3 1.9 cm 4.3 cm 4.3 cm (a) <1 (b) # - / TIC 10-37

10-31 L25x M.I. CPD/ TIS A aprt <1 A aprt >1 TIB 0.17 0.06 (b) p r.3 (MPa) 0.42 W 0 (mw) 1.9 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max 0.7 d eq (Z sp ) (cm) F c (MHz) 6.11 6.10 # A aprt X (cm) 0.52 # Y (cm) 0.30 # PD (μsec) 0.628 PRF (Hz) 3096 p r @PII max (MPa) 0.49 d eq @Pll max (cm) FL x (cm) 2.80 # I PA.3 @MI max (W/cm 2 ) 7.5 FL y (cm) 2.70 # 1 2 CVD CVD 3 2D / / 1.9 cm / 5.1 cm 4/ /401 /4167 5 / / / - (a) <1 (b) # - / TIC 10-38

10-32 L38xi / M.I. TIS A aprt <1 A aprt >1 TIB 1.5 (a) (b) p r.3 (MPa) 3.30 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 4.82 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.544 PRF (Hz) 1312 p r @PII max (MPa) 3.79 d eq @Pll max (cm) FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 605 1 2 3 4 MB 5 FL y (cm) # # 2.0 cm N/A (a) <1 (b) # - / TIC 10-39

10-33 L38xi / M.I. M TIS A aprt <1 A aprt >1 TIB 1.5 (a) 1.2 (b) p r.3 (MPa) 3.54 W 0 (mw) # 37.1 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 0.90 z@pii.3max (cm) 1.0 d eq (Z sp ) (cm) 0.49 F c (MHz) 5.76 # 5.20 # A aprt X (cm) # 1.86 # Y (cm) # 0.40 # PD (μsec) 0.146 PRF (Hz) 1600 p r @PII max (MPa) 4.32 d eq @Pll max (cm) 0.49 FL x (cm) # # I PA.3 @MI max (W/cm 2 ) 776 FL y (cm) # # 1 2 3 4.7 cm 7.3 cm (a) <1 (b) # - / TIC 10-40

10-34 L38xi / CPD/ TIS TIB M.I. TIC A aprt < A 1 aprt >1 1.5 1.1 (b) p r.3 (MPa) 3.30 W 0 (mw) 49.0 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 0.8 d eq (Z sp ) (cm) F c (MHz) 4.82 483 # A aprt X (cm) 0.54 # Y (cm) 0.40 # PD (μsec) 0.544 PRF (Hz) 2190 p r @PII max (MPa) 3.79 d eq @Pll max (cm) FL x (cm) 1.50 # I PA.3 @MI max (W/cm 2 ) 605 FL y (cm) 1.50 # 1 2 CVD CVD 3 2D / 4/ / 2.0 cm /393 / 3.1 cm /2315 5 / / / - (a) <1 (b) # - / 10-41

10-35 P10x CPD/ M.I. TIS A aprt <1 A aprt >1 TIB (a) (a) 1.1 p r.3 (MPa) # W 0 (mw) # 42.2 [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) # d eq (Z sp ) (cm) F c (MHz) # # 3.89 A aprt X (cm) # 0.99 Y (cm) # 0.70 PD (μsec) # PRF (Hz) # p r @PII max (MPa) # d eq @Pll max (cm) FL x (cm) # 6.74 I PA.3 @MI max (W/cm 2 ) # 1 2 3 2D // 4/ 5 / TIC FL y (cm) # 5.00 CVD / 8.9 cm/ /2033 / - (a) <1 (b) # - / 10-42

10-36 rp19x / M.I. TIS A aprt <1 A aprt >1 TIB 1.5 1.0 2.7 p r.3 (MPa) 2.10 W 0 (mw) 96.1 177.8 [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 4.8 d eq (Z sp ) (cm) F c (MHz) 1.99 2.08 1.53 A aprt X (cm) 1.44 0.54 Y (cm) 1.15 1.15 PD (μsec) 0.492 PRF (Hz) 6186 p r @PII max (MPa) 2.92 d eq @Pll max (cm) FL x (cm) 6.43 1.55 I PA.3 @MI max (W/cm 2 ) 184 TIC FL y (cm) 9.00 9.00 1 2 3 10 cm 10 cm 4.7 cm 4 MB/THI / / / 5 N/A N/A (a) <1 (b) # - / 10-43

10-37 rp19x / M.I. M TIS A aprt <1 A aprt >1 TIB 1.5 (a) 1.7 1.0 p r.3 (MPa) 2.10 W 0 (mw) # 55.0 62.1 [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 4.33 z@pii.3max (cm) 4.8 d eq (Z sp ) (cm) 0.43 F c (MHz) 1.99 # 1.81 1.77 A aprt X (cm) # 1.68 1.74 Y (cm) # 1.15 1.15 PD (μsec) 0.492 PRF (Hz) 800 p r @PII max (MPa) 2.92 d eq @Pll max (cm) 0.42 FL x (cm) # 9.82 I PA.3 @MI max (W/cm 2 ) 184 TIC FL y (cm) # 9.00 1 TCD 2 3 7.5 cm 10 cm 16 cm 4 THI (a) <1 (b) # - / 10-44

10-38 rp19x / TIS CPD/ TIB M.I. TIC A aprt <1 A aprt > 1 1.5 1.2 2.5 p r.3 (MPa) 2.10 W 0 (mw) 115.6 170.5 [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) z@pii.3max (cm) 4.8 d eq (Z sp ) (cm) F c (MHz) 1.99 2.14 2.12 A aprt X (cm) 0.78 1.80 Y (cm) 1.15 1.15 PD (μsec) 0.492 PRF (Hz) 505 p r @PII max (MPa) 2.92 d eq @Pll max (cm) FL x (cm) 3.68 9.82 I PA.3 @MI max (W/cm 2 ) 184 FL y (cm) 9.00 9.00 1 TCD 2 /THI CVD/ CVD/ CVD/ 3 2D // / 10 cm/n/a / 7.5 cm/n/a / 16 cm/ 4/ /300 /3125 /5208 5 / / / / (a) <1 (b) # - / 10-45

10-39 Ispta.3 TI / TI MI Ipa.3@MImax TIS TIB TIC Aaprt Pr.3 Wo W.3(z1) ISPTA.3(z1) z1 MI / TIS TIS TIB MI TIS z 1 z 1 / min(w.3 (z), I TA.3 (z) x 1 cm 2 )] z > zbp zbp 1.69 Aaprt zsp MI p r.3 TIB z sp = z b.3 deq(z) z ( 4 ( π) )(( Wo) ( ITA( z) )) I TA (z) z fc ( ) Aaprt PD PRF (x) (y) MI MI 10-46

10-39 p r @PIImax deq@piimax FL (x) (y) Output Display Standard 6.4 10-40 % 95% Pr 1.9% +11.2% Pr.3 1.9% +12.2% Wo 3.4% +10% fc 0.1% +4.7% PII 3.2% +12.5-16.8% PII.3 3.2% +13.47-17.5% 10-47

10-48

IT IT 11 DICOM (Picture Archiving and Communication System, PACS) DICOM (Modality Worklist, MWL) (Modality Performed Procedure Step, MPPS) (Storage Commitment) IT 802.11 b/g/n RJ45 100BASE-TX/10BASE-T IT 11-1

DICOM PACS MWL DICOM DICOM SonoSite Edge II SonoSite SII DICOM www.sonosite.com DICOM 104 2762 11112 WLAN DICOM DICOM MWL ------------------------> SonoSite SII ------------------------> PACS (DICOM MWL) DICOM SonoSite SII DICOM (D18493) 1 IT IT IEC 80001-1:2010 2 IT IT IP IT 1 11-2 IT

Recommended Ultrasound Terminology, Second Edition1997 American Institute of Ultrasound in Medicine (AIUM) A LCD MI/TI NTSC PAL SonoHD2 SonoMB Steep Needle Profiling TIB TIC TIS (MI) (TI) PAL NTSC (ALARA) / A-1

(TI) (MI) L (38) L38xi C (60) rc60xi rp19x 1538.5 / 1 C TI 10-1 MI MI 10-1 A-1 A A PG A/B A2Cd A A A /B 2 A-2

A-1 A2Cs A4Cd A4Cs AAA AAo Abd abs ACC ACS Adur AI AI PHT Ann D ANT F ANT N Ao AoD Apical AT AUA AV AV Area AVA BA 2 4 4 A AUA OB A-3

A-1 Bifur BP BPD BPM Bre BSA CCA CI CM CO CPD Crd CW CxLen D D Apical DCCA DECA DICA Dist dp:dt E E PG E:A E/e' E E E:A E = E e' A-4

A-1 ECA ECICA ECVA EDD by AUA EDD by LMP EDV EF EF:SLOPE EFW Endo Endo Th Epi EPSS Estab.DD ET FM (Right and Left) GA by LMP GA by LMPd Gate Gyn E-F EFW EFW E LMPd SO (LMP) A-5

A-1 HL HR IVRT IVS IVSd IVSFT IVSs LA LA/Ao Lat V LMP LMPd LV LV Area LV mass LV Volume LVd LVD LVDd LVDFS LVDs LVEDV LVESV LVET / A-6

A-1 LVO LVOT LVOT Area LVOT D LVOT VTI LVPW LVPWd LVPWFT LVPWs LVs MB MI MM MR PISA MR/VTI Msk MV MV Area MV Regurgitant Fraction MV Regurgitant Volume MV/VTI MVA MV ERO MV PISA Area MV Rate SonoMB M / / A-7

A-1 Neo Nrv NTSC OB Oph P. Vein PGmax PGmean PGr PHT PI PICA PISA PRF PSV PV PW Qp/Qs RA RI RVD RVDd RVDs RVOT D RVOT VTI A-8

A-1 RVSP RVW RVWd RVWs S/D SI SmP Sup SV TAM TAP TCD TDI THI TI TRmax TV TVA UA VA VArty Vas Ven Vmax / OB A-9

A-1 Vmean VTI YS A-10

2-3, 3-10, 11-1 / (MV/AV) 5-12 4-1 4-1 9-1 (IVC) 5-13 5-14 5-16 4-8 (SmP) 5-15 MSK 5-21 2-15 4-11 2-15 (AAo) 5-11 4-5 6-4 (IVS) 6-4 (CI) 6-3 (HR) 4-19 (SI) 6-7 (SV) 6-8 (HR) 5-20 6-4 5-6 2-15 (EF) 5-14 5-10 AAo 5-11 Ao 5-11 IVC 5-13 5-14 LA 5-11 LV 5-12 LVd 5-13 LVOTD 5-11 LVs 5-13 MV/AV 5-12 TAPSE 5-14 6-3 2-11 2-13, 4-16 4-2 4-5 6-12 (Ao) 5-11 (GA) 5-18, 6-9 6-10 3-11 2-15, 5-18, 6-9 5-19 B-1

(LA) 5-11, 6-4 (LVD) 6-7 6-5 (LVPWFT) 6-7 6-6 6-5 (LVOT D) 5-11 (AUA) 6-8 9-7 9-24 2-15 A-1 2-4, 2-15 9-5, 9-12, 9-22 9-4 9-16 9-23 2-5, 3-8 4-23 7-2 3-8 2-3 9-6 9-7 3-2 9-6 9-4 9-8 9-21 4-12 4-13 5-19 (Msk) 5-15 2-16 5-16 6-11 3-8 1 6-5 2 6-5 2-7, 3-2, 3-5 3-3 1-1 3-4 3-3 2-16 9-22 2-9, 4-7 (OFD) 6-12 1-1 B-2

2-2 2-5 2-2 2-3 (HL) 6-12 6-11 2-16 3-13 2-9 4-5 (FHR) 5-20 (FTA) 6-11 (SmP) 5-15 5-7 (Msk) 5-15 5-8 5-8 5-20 5-7 5-7 (Gyn) 5-16 5-17 5-7 5-6 5-8 9-8 9-22 4-12 3-7 A-1 6-13 6-4 6-5 6-6 5-20 (EF) 6-4 9-22 8-4, 8-8 8-4, 8-8 ECG 8-10 7-4, 8-3 8-4, 8-9 8-6, 8-9 4-8 2-15 2-15 9-11 7-4, 8-12 9-22 3-12 2-10 4-23 3-11 2-7, 4-20, 9-21 4-22 B-3

6-13 6-3 6-12 6-10 6-8 5-16 2-15 3-3 3-6 10-10 10-10 10-10 (CPD) 2-15, 4-4, 4-13, 9-21, 10-1, 10-4 (Color) 2-15, 4-4, 4-13, 9-21, 10-1, 10-4 4-21 5-20 4-17, 4-22 3-10 4-21 10-2 10-2 10-2 2-11 2-9 2-9 2-12 M 4-3 2-12 4-3 M 4-4 2-1, 7-2 6-2 2-9, 2-12 (LCD) A-1 8-4, 8-8 8-4, 8-8 ECG 8-10 Spaulding 8-2 8-1 2-9 2-10, 4-1 4-3 A-2 MI 10-3 TI 10-4 3-11 4-6 5-17 2-15 10-2 10-2 9-16 2-3 10-11 (THI) 4-2 B-4

9-22 9-22 9-23 9-23 9-20 9-21 3-1 2-15 7-2 6-11 5-20 3-12, 4-3, 5-2 4-2 5-6 5-1 5-1 5-4 5-6 (HR) 5-13 6-2 5-2, 5-21 5-4 5-20 5-7 5-4 6-2 5-2 5-2 5-2, 5-4 5-5 5-2, 6-1 (AC) 6-10 6-2 5-2 5-2 5-3 M 5-5 5-18 2-10 3-3 3-2 4-16 3-6 3-6 4-17 A-1 2-5 5-1 5-2, 5-4 M 5-5 6-8 3-4 3-7 3-5 3-4 3-7 4-24 B-5

2-16 3-3 9-22 10-8 2-16 2-15 9-6 8-12 9-22 2-4 9-6 2-3 2-2 3-10 9-22 9-23 3-7 9-4 2-4, 2-15 2-3, 9-4 3-8 3-10 2-2 9-13 9-23 2-2 7-1 9-22 2-5 9-8 (EFW) 5-17, 6-9 (EDD) 6-8 (CSA) 6-3 7-1 4-2 3-2 3-2 10-47 3-9 3-10 2-2 7-3 7-2 4-2 3-11 6-2 6-2, 10-8 6-2 2-9 2-1 4-1 4-2 2-9, 4-2 4-3 7-2 2-12, 4-7 4-23 4-23 4-24 4-23 B-6

USB 4-24 4-20 4-22 7-1 2-7, 9-21 9-24 9-23 EMC 9-24 HIPAA 9-25 3-6, 4-16 9-16 3-10 (TI) 3-11, 10-7 4-16 CPD 4-5 4-5 5-2, 5-4 (MI) 2-10, 10-2, 10-7, A-2 9-24 9-23 10-1, 10-7 2-5, 9-5 7-2 4-8 6-12 5-7 5-3 4-20 9-22 9-21 4-18 4-12 4-13 4-12 4-13 9-13, 9-19, 9-22 4-7 A-2 10-47 10-2 10-11, 10-46 10-46 10-9 2-13 USB 2-13, 4-21 DICOM 4-24 USB 4-24 5-16 B-7

2-14 4-13 A-2 A-2 A-2 2-14 7-2 2-6 2-14 8-11 4-13 2-14 3-12 (BPD) 6-10 4-2 3-8 2-10, 2-12 3-9 3-7 1-1 (BSA) 6-3 5-15 5-15 9-11, 9-21 9-5 ALARA 9-7, 10-1, A-1 Color (Color) CPD (CPD) DICOM 3-8, 3-13, 4-24, 9-24, 11-1 11-2 DVD 3-8, 7-2 EDD (AUA) 6-8 (LMP) 6-8 EMC 9-24 FL/AC 6-12 FL/BPD 6-13 FL/HC 6-13 HC/AC 6-13 HDMI 2-3 HDMI 2-2 HIPAA 9-25 LCD 10-7 LMP 4-20 LVD 6-7 LVd 5-13 LVDd 5-14 LVDs 5-14 LVs 5-13 M 4-3 4-3 4-3 5-5 M 4-3 MSK 5-21 NTSC B-8

A-1 3-8 OB 6-8 PAL A-1 3-8 PC 3-8 PRF 4-5 RA 5-21 Save 3-12 SNP 4-8 SonoHD A-1 SonoMB 4-2 Spaulding 8-2 Steep Needle Profiling (SNP) 4-8 USB 2-3 2-7 4-24 B-9

B-10

P20554-03 *P20554-03*