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2 FUJIFILM SonoSite, Inc th Drive SE Bothell, WA FUJIFILM SonoSite B.V. Joop Geesinkweg 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 FUJIFILM SonoSite US 8,861,822 US 8,858,436 US 8,834,372 US 8,805,047 US 8,439,840 US 8,398,408 US 8,355,554 US 8,216,146 US 8,213,467 US 8,147,408 US 8,137,278 US 8,088,071 US 8,066,642 US 8,052,606 US 7,819,807 US 7,804,970 US 7,740,586 US 7,686,766 US 7,604,596 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 6,575,908 US 6,569,101 US 6,471,651 US 6,416,475 US 6,383,139 US 6,364,839 US 6,203,498 US 6,135,961 US 5,893,363 US 5,817,024 US 5,782,769 US 5,722,412 AU: AU: CA:2,372,152 CA:2,371,711 CN B CN B CN CN CN DE DE DE DE DE DE DE EP EP EP EP EP EP EP ES ES ES ES FR FR FR FR FR FR GB GB GB GB GB GB GB IT IT IT IT JP JP KR KR NO NO P FUJIFILM SonoSite, Inc. ii

3 USB iii

4 USB JPEG D M CPD Color Steep Needle Profiling iv

5 D M (Gyn) OB MSK v

6 vi

7 EMC DICOM HIPAA ALARA ALARA MI TI MI TI In Situ vii

8 viii

9 1 SonoSite SII SonoSite SII FUJIFILM SonoSite

10 FUJIFILM SonoSite

11 2 SonoSite SII SonoSite SII S-Total S-Vascular S-Vet 90 FUJIFILM SonoSite USB USB Patient Information 4 Mode 2D 3

12 USB 2-1 USB RJ45 HDMI 2-1 4

13 USB HDMI HDMI

14 V 131 6

15 FUJIFILM SonoSite

16 SonoSite SII

17 5 1 2 USB USB PC USB USB PC USB USB USB USB USB USB USB USB USB 9

18 USB USB USB USB USB USB USB 2-1 USB USB USB USB 1 USB 5 2 USB 10

19

20 SonoSite SII

21 (ROI) Select 13

22 SonoSite SII USB USB USB TAB FUJIFILM SonoSite USB USB 14

23 1 2 Äñ Symbols Caps Lock SHIFT Delete 3 Next Prev 4 OK 2D 2D 15

24 21 CFR FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 93 FUJIFILM SonoSite Aquasonic

25 SonoSite SII 41 CPD Color (PUBS) in vitro (IVF) CPD (IUGR) 17

26 (Oph) FDA Oph SonoSite SII 18

27 3 1 Settings 2 Settings Pages 3 Done Administration 1996 (Health Insurance Portability and Accountability Act, HIPAA) (European Union Data Protection Directive, 95/46/ EC) HIPAA 19

28 1 Administration Name Administrator14 Name Password 2 Password FUJIFILM SonoSite2 3 Login User Login 1 2 User Login On On Off 1 2 User List Administrator 3 a User Information Password b Confirm 23 4 Password changes 5 Save 20

29 1 2 New 3 User Information Name Password Confirm 23 User Administration Access 4 Save 1 2 User List 3 User Information 4 Save 1 2 User List 3 Delete 4 Yes 1 2 User List 3 Password Confirm 4 Save 21

30 1 USB 9 USB 2 3 Export USB 4 USB Export USB 1 USB 9 USB 2 3 Import 4 USB Import 5 Restart USB PC User Login OK 22

31 1 2 User Login Guest 1 2 User Login Password 3 OK (A-Z) (a-z) (0-9) Annotations AnnotationsExam 2 Group A B C 3 a <New> b Text c Add 23

32 4 a b Text c Rename 5 a b 6 Delete 14 Annotations Unfreeze Keep All Text Keep Home Text Clear All Text Keep All Text 46 1 USB 2 Annotations Export USB 3 USB Export USB 1 USB 2 Annotations Import 3 USB Import 4 OK USB 24

33 Audio, Battery Key click On Off Beep alert On Off Sleep delay Off 5 10 Power delay Off Connectivity PDAS Image Manager and DICOM PDAS DICOM 1 2 Connectivity Printer 3 25

34 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 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 26

35 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 14 b Time 24 Display Information ID 47 27

36 Network Status IP MAC OB Calculations 71 OB OB Calculations Gestational Age None Presets 1 2 TIS TIB TIC OB TIB TIS in/ft/lbs cm/m/kg 28

37 Save / M 1/3 2D, 2/3 Trace 1/3 2/3 1/3 2/3 1/2 2D, 1/2 Trace 1/2 1/2 1/2 Full 2D, Full Trace System Information 91 System Information Patents USB USB Devices USB USB USB 29

38 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 BMP SonoCalc IMT BMP SonoCalc IMT "Physics in Medicine and Biology, Quality Assessment of DSA, Ultrasound and CT Digital Images Compressed with the JPEG Protocol," D Okkalides et al Phys Med Biol doi: / /39/9/ "Canadian Association of Radiologists, CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology," Approved: June USB

39 4 SonoSite SII LCD 41 2D 2D 28 2D 1 2D 2 2D 2D 31

40 D Gain Depth Auto Gain Optimize THI SonoMB Guide Dual Monitor Gain Depth 35 Res Gen Pen THI SonoMB MB U/R / U/L / D/L / D/R / Guide A B C A B C Guide 2D Dual Update 2D Off Monitor

41 M (M Mode) 2D 2D M 1 M M 2 M 3 4 M M M Mode 4-2 M Mode Gain Depth M line position M Scan speed Gain Depth M Fast Med Slow M 1 M M 33

42 4 M ms 1 5 Slow Med Fast Update M M Update 2D 2D M M CPD Color (CPD) Color CPD Color 1 C Color ROI 2D Color CPD Color Color cm/s 2 CPD CPD 3 ROI Position Size 4 CPD Color 34

43 CPD Color 4-3 CPD Color Flow Sensitivity PRF Scale PRF Invert Steering Wall Filter Variance Flow Low Flow Med Flow High PRF PRF PRF Color Steering WF Low WF Med WF High M 0.5 cm 1 cm 5 cm Depth 35

44 28 2D Auto Gain 31 2D 1 Gain 2 Gain Gain ( ) () 36

45 2D Color 1 Zoom ROI 2 ROI 3 Zoom ROI 100% 4 5 Zoom Off Steep Needle Profiling (SNP) FUJIFILM SonoSite CIVCO FUJIFILM SonoSite SNP Steep Needle Profiling - - Steep Needle Profiling SNP Steep Needle Profiling SonoMBe 4-1 Steep Needle Profiling

46 SNP 2D 4-4 SNP rc60xi & rc60xi HFL38xi HFL50x HSL25x L25x L38xi & L38xi SNP 4-1 SNP

47 A B C Steep Needle Profiling Steep Needle Profiling SNP Steep Needle Profiling L/R Flip / 31 2D Shallow Medium Steep 30 Shallow Medium 40 Steep Off SNP SNP Steep Needle Profiling (MB) 39

48 Steep Needle Profiling

49 4-5 (Oph) FDA Oph 1 Transducer 2 Switch 41

50 Transducer Patient Information Exam Type B & M CPD Color C11x rc60xi rc60xi HFL38xi & 42

51 4-5 B & M CPD Color HFL50x & HSL25x & ICTx 43

52 4-5 B & M CPD Color L25x & L38xi L38xi 44

53 4-5 B & M CPD Color P10x / / rp19x rp19x / 45

54 23 1 Label 2 Text A B C Done 1 Label 2 Arrow Done 46

55 1 Label 2 Picto 3 X/X U/L / D/L / D/R / U/R / 7 Done 74 1 Patient 47

56 2 End Done 52 Auto save Pat Form On Patient 2 Information Done Patient 3 Information 4 End 48

57 Last First Middle Patient name ID Accession Date of birth Gender Indications User Procedure Worklist 1 Query Patient Information Exam BP HR 1. DICOM Worklist DICOM 49

58 (BSA) OB LMP Estab. DD Gyn LMP OB Gyn ID Beep Alert

59 28 FUJIFILM SonoSite 2 1 Patient 2 Review List Select All USB 51

60 Clear All USB ID 1 2 Edit 3 Done 1 2 Append 1 2 Review 3 52

61 4 Play Pause Play 5 6 List 7 Done 1 USB 2 Patient Review 3 List Image Gallery 4 Select USB USB 5 USB Select 6 USB USB USB USB 53

62 USB USB USB 9 USB 2 3 Exp.USB USB USB 54

63 4 USB Include patient information on images and clips USB 5 Export USB 5 USB 6 Cancel Export 1 2 Delete SonoPHI DICOM PC DICOM SonoPHI SonoPHI DICOM 1 2 Archive 1 2 Info 55

64 56

65 5 77 M HR 59 57

66 1 Calipers 2 Ellipse Trace Delete 58

67 Calcs

68 5-1 2D 2D cm 1 2D Calipers A 2 3 cm 2 cm 1 2D Calipers 2 Ellipse 60

69 D Calipers 2 Trace Undo 6 Set M M cm / (HR) / (bpm) 200 ms 1 61

70 M 4 1 M Calipers M 1 M Calipers 2 Heart Rate Save Heart Rate 74 M 62

71 M Add Caliper B C Heart Rate (...) 1 Calcs 2 a Next Prev (...) 63

72 b 3 Done Calcs Calipers Save Save Calc Delete 74 64

73 LVd LVs IVC Atria Ao/LA RVW (2D) RVD (2D) IVS (2D) LVD (2D) LVPW (2D) RVW (2D) RVD (2D) IVS (2D) LVD (2D) LVPW (2D) Max D Min D LA A4C LA A2C RA Ao 2D M AAo (2D) LA 2D M LVOT D (2D) LVESV LVEDV IVSFT LVDFS LVPWFT LV M EF CO CI SV SI Max D Min D (%) LA A4C LA A2C LA RA Ao LA/Ao AAo LA LA/Ao LVOT D LVOT 65

74 5-1 MV Area LV mass LV EF EF: M EPSS M AV (2D) MV (2D) Epi (2D) Endo (2D) Apical (2D) LVDd LVDs EF EPSS AV MV LV Epi Endo D Apical EF LVESV LVEDV LVDFS CO CI SV SI TAPSE TAPSE TAPSE LVd LVs 1 2D M Calcs 2 EF 3 EF LVd LVs 4 a LVd LVs b 57 c Save Calc 5 Done 66

75 Ao LA AAo LVOT D 1 2D M Calcs 2 Ao/LA 3 Ao/LA Save Calcs 6 Done MV AV 1 2D Calcs 2 Area 3 Area MV AV 4 5 Undo 6 Set 7 Save Calc 64 8 Done 67

76 LV 1 2D Calcs 2 LV mass LV 3 EPI Endo a LV mass LV b c Undo d Set e Save Calc 4 LV mass LV Apical Done LVd LVs 1 2D M Calcs 2 LVd LVs 68

77 3 a LV b 57 c Save Calc 4 Done IVC 1 2D Calcs 2 IVC 3 Max D Min D a IVC b 57 c Save Calc 4 Done EF 1 M Calcs 2 EF 3 LVDd LVDs a EF b 57 c Save Calc 69

78 4 Done 64 (Gyn) (Gyn) D Calcs 2 a b 57 c D Calcs 2 Follicle 70

79 3 a Right Fol Left Fol b 57 c 64 OB EFW EDD OB EFW OB OB OB 71 OB 47 OB

80 5-2 OB 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. a FL Chitty, Hadlock, Hansmann, Osaka, Tokyo U. HL Jeanty Jeanty TCD CM Lat V CxLen a. AUA b. Toyko U APTD TTD EFW c. (Estimated Fetal Weight) EFW 28 Hadlock EFW

81 5-2 OB HC, AC, FL Hadlock 1 BPD, AC, FL Hadlock 2 AC, FL Hadlock 3 (EFW) c BPD Hansmann BPD, FL Osaka U. BPD, AC BPD, TTD, APTD, FL HC/AC FL/AC FL/BPD FL/HC Shepard Tokyo U. Campbell Hadlock Hohler Hadlock Q 1, Q 2, Q 3, Q 4 Jeng a. AUA b. Toyko U APTD TTD EFW c. (Estimated Fetal Weight) EFW 28 Hadlock EFW (2D) 2D CxLen YS 1 OB LMP Estab.DD 2 2D Calcs 73

82 3 a b 57 c Save Calc d Done M 1 M Calcs 2 FHR Save Calc 6 Done (###) \

83 1 Patient Report 2 x/x 3 Done Save 1 2 Delete 1 Details Details 2 3 Delete RA Summary RA 5 RA RVSP 75

84 MSK MSK MSK MSK 1 Patient MSK 2 Worksheet 3 x/x Comments 4 Save 5 MSK Done 76 MSK

85 6 2D

86 6-1 a b (cm) < ±2% + 1% 0-26 cm < ±2% + 1% 0-35 cm < ±2% + 1% 0-44 cm c < ±4% + ( 2%/) * % c < ±3% + ( 1.4%/) * % cm cm a. b. 0.7 db/cm MHz RMI 413a c. % = ((1 + ) * (1 + ) - 1) * % d. % = ( 2 (2 ) * 100) + 0.5% AIUM 78

87 (BSA) m 2 Grossman, W. Cardiac Catheterization and Angiography. Philadelphia: Lea and Febiger, (1980), 90. BSA = * * = = (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), 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), 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), CSA = * D 2 D = 79

88 (EF) Oh, J. K., J. B. Seward, & A. J. Tajik. The Echo Manual. 3rd e d. Ph i lad e lp hi a: L i p p i n co t t Wi ll i am s & Wi lk i n s, (2 00 7), EF = ((LVEDV - LVESV)/LVEDV) * 100% EF = LVEDV = LVESV = (HR) bpm HR = M (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 Lang R. et al. "Recommendations for Cardiac Chamber Quantification: A report from the American Society of Echocardiography s Guidelinesand 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: 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 = 80

89 2 LA Vol = p/4(h) Σ(D1)(D2) LA h D1 D2 1 LA Vol =p/4(h) Σ(D1) 2 2 LA Vol LA Vol = 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), LV = 1.04 [(LVID + PWT + IVST) 3 - LVID 3 ] * LVID = PWT = IVST = 1.04 = 0.8 = 81

90 gm 2D 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. V = π -- 4 n i = 1 L a i b i -- n V = ml a = b = n = (n=20) L = i = 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 82

91 V = a = 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), SI = SV/BSA SV = BSA = (SV) 2D M 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 = LVEDSV = 83

92 (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), (AUA) AUA (AUA) (EDD) / / EDD = + (280 - AUA ) (LMP) (EDD) LMP / / EDD = LMP (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), 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), 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), 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 84

93 (Estab. DD) (LMPd) (GA) (Estab. DD) (GA) LMP GA(LMPd) = - LMPd (Estab. DD) (LMPd) / / LMPd(Estab. DD) = Estab. DD (AC) Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152:(1984), 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),

94 (BPD) Chitty, L. S. and D.G. Altman. "New charts for ultrasound dating of pregnancy." Ultrasound in Obstetrics and Gynecology 10:(1997), , Table 3. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152:(1984), 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. (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), 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), , Table 8, 186. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152:(1984), 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), 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),

95 (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). (HC) Chitty, L. S. and D.G. Altman. "New charts for ultrasound dating of pregnancy." Ultrasound in Obstetrics and Gynecology 10:(1997), , Table 5, 182. Hadlock, F., et al. "Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters." Radiology, 152:(1984), 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), (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), (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),

96 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), 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 ), 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), 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), (Vol) Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987),

97 7 FUJIFILM SonoSite LCD 2 3 CPD Color OB OB 89

98 1 Connectivity C: FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite

99 7-1 ARM PCBA PCBA 1 2 Enter license number 3 Done FUJIFILM SonoSite 2 4 Done FUJIFILM SonoSite 2 91

100 93 FUJIFILM SonoSite 92

101 8 FUJIFILM SonoSite 2 (PPE) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 93

102 FUJIFILM SonoSite (FDA) A B

103 8-1 A (PPE) FUJIFILM SonoSite 95

104 a / / 1 2 SaniCloth AF3 3 SaniCloth Plus b c d e 96

105 6 SonoSite SII 7 a 1 2 SaniCloth AF3 3 SaniCloth Plus PI-Spray II C11x HFL38xi HFL50x HSL25x ICTx L25x P10x L 38xi & L38xi rc60xi & rc60xi rp19x & rp19x b c d

106 9 a Cidex C11x HFL38xi HFL50x HSL25x ICTx L25x P10x L38xi rc60xi rp19x L38xi rc60xi rp19x 25 o C 45 b c d 10 a FUJIFILM SonoSite 98

107 b 5 cm 5 cm v a 1 b cm c FUJIFILM SonoSite 99

108 B A 95 (PPE) FUJIFILM SonoSite

109 5 a / / 1 2 SaniCloth AF3 3 SaniCloth Plus b c d 6 a / 1 SaniCloth AF3 2 SaniCloth Plus PI-Spray II C11x HFL38xi HFL50x HSL25x ICTx L25x P10x L38xi L38xi rc60xi rc60xi rp19x rp19x b c d 101

110 FUJIFILM SonoSite 1 2 X 0 C +45 C 102

111 1 ISO FUJIFILM SonoSite FUJIFILM SonoSite C +65 C 103

112 SonoSite SII ECG ECG ECG ECG ECG

113 2% 10% ECG ECG ECG 10 1 (EtO) ECG 2 105

114 106

115 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), b. Craig, M. "Sonography: An Occupational Health Hazard?" Journal of Diagnostic Medical Sonography. 3 (1985), 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),

116 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), b. Habes, D.J. and S. Baron. "Health Hazard Report " 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),

117 MSD MSD 109

118 Class I I BF IPX 0 IPX-7 AP/APG Class I I SonoSite SII EN Class I I / BF

119 Hospital Only Hospital Grade / ( MSO 89 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite SonoSite SII / FUJIFILM SonoSite 111

120 89 / 112

121 0 40 C 60 C 6 FUJIFILM SonoSite 2 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 113

122 FUJIFILM SonoSite 21 CFR ALARA MI TI FUJIFILM SonoSite.3dB/cm/MHz IEC :2001 (EMC) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite

123 EMC RF (EMI) EMI EMI EMI EMI EMI EMI EMI IEC EMC SonoSite SII IEEE GHz GHz ISM 16 db (CCK) (DQPSK) (DBPSK) IEEE b 13 dbm (ODFM) IEEE g 115

124 (ESD) ESD ESD ESD ESD ESD 9-1 ESD ESD ESD ESD IEC d 116

125 FUJIFILM SonoSite SonoSite SII IEC :2007 FUJIFILM SonoSite SonoSite SII SonoSite SII 9-1 SonoSite SII rc60xi HFL38xi HFL50x HSL25x ICTx L25x L38xi rp19x P10x PowerPack 1.7 m 1.7 m 1.7 m 2.4 m 1.7 m 2.3 m 1.7 m 1.8 m 1.8 m 2 m SonoSite SII AC rp19x rc60xi L38xi 1 m 1.8 m 1.7 m 1.7 m 117

126 9-1 SonoSite SII C11x DC 1.8 m 2 m EMC iviz EMC

127 9-2 SII GB 4824 GB 4824 GB / 1 A SII SII 9-3 SII (ESD) GB/T ±6kV ±8kV ±6kV ±8kV 30 GB/T ±2kV ±2kV GB/T ±1kV ±2kV ±1kV ±2kV 119

128 9-3 SII GB/T /60Hz GB/T < 5% U T 0.5 U T > 95% 40% U T 5 U T 60% 70% U T 25 U T 30% < 5% U T 5s U T > 95% 3 A/m 3 A/m < 5% U T 0.5 U T > 95% 40% U T 5 U T 60% 70% U T 25 U T 30% < 5% U T 5s U T > 95% SII U T 120

129 9-3 SII GB/T GB/T V 150kHz - 80MHz 3 V/m 80MHz - 2.5GHz 3 V 3 V/m d = 1.2 P 150kHz-80MHz d = 1.2 P 150kHz-80MHz d = 1.2 P 150kHz-80MHz P (W) d (m) a b 1 80MHz 800MHz 2 a. / b. 150kHz-80MHz3V/ M 121

130 9-4 SII W 150kHz - 80MHz d = 1.2 P /m 80MHz - 800MHz d = 1.2 P 800MHz - 2.5GHz d = 2.3 P d m P W 180MHz 800MHz 2 FCC FCC Rules 15 FCC Rules 15 SonoSite SII IEC IEC SonoSite SII 122

131 (AC) I 93/42/EEC Annex VII I IIa IIb III 93/42/EEC 123

132 "C" "US" CSA ANSI/UL REF 93/86/EEC STERILE EO (DC)

133 10 FCC GEL STERILE R SN 125

134 SonoSite SII BF B = F = RoHS / CCC 126

135 WARNING: Connect Only Accessories and Peripherals Recommended by FUJIFILM SonoSite FUJIFILM SonoSite 44.7 cm 151 cm cm 28.7 cm 12.2 cm 5.7 kg 26.1 kg 127

136 9-5 C11x rc60xi HFL38xi HFL50x HSL25x ICTx L25x L38xi P10x rp19x L38xi rc60xi 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 1.8 m 1.8 m 1.7 m 1.7 m 1.8 m 2D 256 Color power Doppler (CPD) 256 Color Doppler (Color) 256 M Tissue Harmonic Imaging (THI) THI 128

137 Power Park EN USB Sony DVD Kensington USB 9-6 (mm) Color (cm) Power (cm) rc60xi ±5 ±10 HFL50x ±5 ±10 ICTx ±5 ±10 HSL25x ±5 ±10 129

138 9-6 (mm) Color (cm) Power (cm) L38xi ±5 ±10 C11x ±5 ±10 HFL38xi ±5 ±10 L25x ±5 ±10 rp19x ±5 ±10 P10x ±5 ±10 (mm) Color (cm) Power (cm) rc60xi ±5 ±10 rp19x ±5 ±10 L38xi ±5 ± C 15-95% hpa C 15-95% hpa C 15-95% hpa

139 VAC, 50/60 Hz, A # VDC 5.0 A # VDC 2.3 A # VDC 5.0 A # VDC 5.0 A # VDC 2.3 A # VDC 1.8 A 75 w 10.8 VDC 5.8 AH 131

140 9-7 ANSI/AAMI ES :2005/(R) 2012 A1:2012 CAN/CSA C : IEC : IEC :2007 IEC :2010 JIS T0601-1: EMC 9-8 EMC IEC :2007 CISPR 11: (ISM) - 1 A 132

141 AAMI/ANSI/ISO : [2009] AAMI/ANSI/ISO In Vitro [2009] AAMI/ANSI/ISO [2002] AAMI/ANSI/ISO [2006] AAMI/ANSI/ISO [2007] 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 B DICOM SonoSite Edge II SonoSite SII DICOM DICOM HIPAA HIPAA The Health Insurance Portability and Accountability Act, Pub.L. No (1996).45 CFR 160, General Administrative Requirements 45 CFR 164, Security and Privacy 133

142 134

143 10 ALARA ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI ALARA ALARA 135

144 EN (ISPTA) 720 mw/cm 2 ISPTA 50 mw/cm 2 TI 1.0 MI 0.23 (MI) (TI) 1.0 MI TI 137 MI TI ALARA MI TI MI TI BS EN :2001: Annex HH HH PRF Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). 136

145 MI TI MI TI MI TI MI TI MI TI 10-1 MI C11x rc60xi & rc60xi HFL38xi HFL50x HSL25x ICTx L25x L38xi L38xi P10x rp19x rp19x MI MI MI TI 137

146 10-2 TI CPD PRF C11x rc60xi rc60xi HFL38xi HFL50x HSL25x ICTx L25x L38xi L38xi P10x rp19x rp19x TI TI 138 MI TI

147 MI TI AIUM TI MI TI MI 1.0 /M / C11x/8-5 MI TIC TIB TIS rc60xi/5-2 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 L38xi/10-5 L38xi /10-5 MI TIC TIB TIS MI 1.0 MI 0.1 TI TI -0.1 TI TI ALARA TI FUJIFILM SonoSite AIUM TI

148 10-3 TI MI 1.0 /M / P10x/8-4 MI TIC TIB TIS rp19x/5-1 rp19x /5-1 MI TIC TIB TIS MI 1.0 MI 0.1 TI TI -0.1 TI TI ALARA TI FUJIFILM SonoSite AIUM TI 141 P11x P11x P11x MI TI MI 95% MI 95% MI +18% -25% +0.2 TI 95% TI 95% TI +21% -40% dB 3dB MI TI MI TI 140

149 / / Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN reprinted at P (23 C ± 3 C) EN P11x P11x P11x 10-4 ( C) C11x rc60xi HFL38xi HFL50x HSL25x L25x L38xi P10x rp19x

150 10-4 ( C) 10-5 ( C) rc60xi rp19x L38xi ICTx (bioeffects) (AIUM) (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988:Vol. 7, No. 9 Supplement) Stowe 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) In Situ In Situ In Situ = [e -(0.23alf ) ] In Situ = In Situ = e = a = (db/cm MHz) 142

151 = 0.53 = 0.66 = 0.79 = 0.43 = 0.55 l = cm f = / / MHz In Situ 0.3 In Situ In Situ = [e -(0.069lf ) ] In Situ In Situ In Situ 0.3 db/cm MHz In Situ In Situ 3 cm In Situ 1 db/cm MHz 143

152 1990 MI MI 2.0 M MI C 4 C 1.5 C 7 C I SPTA 500 mw/cm 2 Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) TI MI

153 10-6rC60xi & 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) PRF (Hz) 3584 p max (MPa) 3.29 d max (cm) FL x (cm) # # I max (W/cm 2 ) MB FL y (cm) # # Res 11 cm 5 THI (a) <1 (b) # / TIC 145

154 10-7rC60xi & rc60xi / M.I. TIS A aprt <1 A aprt >1 TIB (b) p r.3 (MPa) 2.21 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) # A aprt X (cm) 0.66 # Y (cm) 1.20 # PD (μsec) PRF (Hz) 1265 p max (MPa) 3.07 d max (cm) # FL x (cm) 2.50 # I max (W/cm 2 ) 342 FL y (cm) 6.50 # 1 2 CVD CVD 3 2D //THI Gen/11 cm/ Gen/4.7 cm/ 4 /PRF /342 /3125 5/ / - / - (a) <1 (b) # / TIC 146

155 10-8rC60xi & rc60xi M M.I. 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) PRF (Hz) 800 p max (MPa) 3.25 d max (cm) 0.49 FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) Msk 2 Pen Pen cm 9.2 cm 4 THI (a) <1 (b) # / TIC 147

156 10-9HFL38xi 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) PRF (Hz) 2127 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) MB FL y (cm) # # Res 3.3 cm N/A 5 (a) <1 (b) # / TIC 148

157 10-10HFL38xi M MI 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) PRF (Hz) 1600 p max (MPa) 4.35 d max (cm) # FL x (cm) # # I max (W/cm 2 ) FL y (cm) # # Nrv Pen 4.0 cm (a) <1 (b) # / TIC 149

158 10-11HFL38xi / 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 (MHz) 5.36 # # A aprt X (cm) # # Y (cm) # # PD (μsec) PRF (Hz) 2223 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4 //PRF FL y (cm) # # SmP CVD Res/ 3.3 cm /401 5/ / (a) <1 (b) # / TIC 150

159 10-12HFL50x MI TIS A aprt <1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 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) PRF (Hz) 2733 p max (MPa) 3.81 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) MBe (a) <1 (b) # / TIC 151

160 10-13HFL50x M M.I. 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) PRF (Hz) 1600 p max (MPa) 4.35 d max (cm) # FL x (cm) # # I max (W/cm 2 ) FL y (cm) # # Pen (a) <1 (b) # / TIC 152

161 10-14HFL50x / 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) PRF (Hz) 8233 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) / 4 PRF FL y (cm) # # /3.3 (a) <1 (b) # / TIC 153

162 10-15HSL25x 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) PRF (Hz) 1061 p max (MPa) 3.39 d max (cm) FL x (cm) # # I max (W/cm 2 ) 478 FL y (cm) # # 1 Nrv/Msk/ Ven/Art MBe (a) <1 (b) # / TIC 154

163 10-16HSL25x / 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) PRF (Hz) 3079 p max (MPa) 2.78 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4 //PRF FL y (cm) # # Sup CVD / 3.1 cm /401 5/ / (a) <1 (b) # / TIC 155

164 10-17HSL25x M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.96 # Y (cm) 0.30 # PD (μsec) PRF (Hz) p max (MPa) 0.58 d max (cm) FL x (cm) 3.80 # I max (W/cm 2 ) Oph Oph 2 Res Pen cm 4.3 cm 4 MB FL y (cm) 2.70 # (a) <1 (b) # / TIC 156

165 10-18HSL25x M M.I. TIS A aprt <1 A aprt >1 TIB (b) p r.3 (MPa) 0.47 W 0 (mw) # [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) # A aprt X (cm) # Y (cm) # PD (μsec) PRF (Hz) 1600 p max (MPa) 0.61 d max (cm) 0.27 FL x (cm) 3.80 # FL y (cm) 2.70 # I max (W/cm 2 ) Oph Oph Oph 2 Res Pen Pen cm 4.3 cm 4.3 cm (a) <1 (b) # / TIC 157

166 10-19HSL25x / M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.52 # Y (cm) 0.30 # PD (μsec) PRF (Hz) 3096 p max (MPa) 0.49 d max (cm) FL x (cm) 2.80 # I max (W/cm 2 ) Oph Oph 2 CVD CVD 3 2D / FL y (cm) 2.70 # / 1.9 cm / 5.1 cm 4 /PRF /401 /4167 5/ / / - (a) <1 (b) # / TIC 158

167 10-20L25x 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) PRF (Hz) 1061 p max (MPa) 3.39 d max (cm) FL x (cm) # # I max (W/cm 2 ) 478 FL y (cm) # # 1 Nrv/Msk/ Ven/Art MBe (a) <1 (b) # / TIC 159

168 10-21L25x / 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) PRF (Hz) 5261 p max (MPa) 2.78 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4 /PRF FL y (cm) # # CVD / 3.1 cm /779 5/ / (a) <1 (b) # / TIC 160

169 10-22L25x M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.96 # Y (cm) 0.30 # PD (μsec) PRF (Hz) p max (MPa) 0.58 d max (cm) FL x (cm) 3.80 # I max (W/cm 2 ) Oph Oph 2 Res Pen cm 4.3 cm 4 MB FL y (cm) 2.70 # (a) <1 (b) # / TIC 161

170 10-23L25x M M.I. TIS A aprt <1 A aprt >1 TIB (b) p r.3 (MPa) 0.47 W 0 (mw) # [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) # A aprt X (cm) # Y (cm) # PD (μsec) PRF (Hz) 1600 p max (MPa) 0.61 d max (cm) 0.27 FL x (cm) 3.80 # FL y (cm) 2.70 # I max (W/cm 2 ) Oph Oph Oph 2 Res Pen Pen cm 4.3 cm 4.3 cm (a) <1 (b) # / TIC 162

171 10-24L25x / M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.52 # Y (cm) 0.30 # PD (μsec) PRF (Hz) 3096 p max (MPa) 0.49 d max (cm) FL x (cm) 2.80 # I max (W/cm 2 ) Oph Oph 2 CVD CVD 3 2D / FL y (cm) 2.70 # / 1.9 cm / 5.1 cm 4 /PRF /401 /4167 5/ / / - (a) <1 (b) # / TIC 163

172 10-25L38xi & 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) PRF (Hz) 1312 p max (MPa) 3.79 d max (cm) FL x (cm) # # I max (W/cm 2 ) MB FL y (cm) # # Nrv Res 2.0 cm N/A 5 (a) <1 (b) # / TIC 164

173 10-26L38xi & L38xi M M.I. 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) PRF (Hz) 1600 p max (MPa) 4.32 d max (cm) 0.49 FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) Art Art 2 Gen Pen cm 7.3 cm (a) <1 (b) # / TIC 165

174 10-27L38xi & L38xi / M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.54 # Y (cm) 0.40 # PD (μsec) PRF (Hz) 2190 p max (MPa) 3.79 d max (cm) FL x (cm) 1.50 # I max (W/cm 2 ) 605 FL y (cm) 1.50 # 1 Art 2 CVD CVD 3 2D / / 2.0 cm / 3.1 cm 4 /PRF /393 /2315 5/ / / - (a) <1 (b) # / TIC 166

175 10-28P10x / 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 max (MPa) # d max (cm) FL x (cm) # 6.74 I max (W/cm 2 ) # D // 4 /PRF TIC FL y (cm) # 5.00 CVD /8.9 cm/ /2033 5/ / - (a) <1 (b) # / 167

176 10-29rP19x & rp19x M.I. TIS A aprt <1 A aprt >1 TIB p r.3 (MPa) 2.10 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) 4.8 d eq (Z sp ) (cm) F c (MHz) A aprt X (cm) Y (cm) PD (μsec) PRF (Hz) 6186 p max (MPa) 2.92 d max (cm) FL x (cm) I max (W/cm 2 ) 184 FL y (cm) Gen Res Pen 3 10 cm 10 cm 4.7 cm 4 MB/THI Off/Off Off/Off / 5 N/A N/A (a) <1 (b) # / TIC 168

177 10-30rP19x & rp19x M M.I. TIS A aprt <1 A aprt >1 TIB 1.5 (a) p r.3 (MPa) 2.10 W 0 (mw) # [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 # A aprt X (cm) # Y (cm) # PD (μsec) PRF (Hz) 800 p max (MPa) 2.92 d max (cm) 0.42 FL x (cm) # 9.82 I max (W/cm 2 ) 184 TIC FL y (cm) # TCD 2 Gen Res Res cm 10 cm 16 cm 4 THI (a) <1 (b) # / 169

178 10-31rP19x & rp19x / M.I. TIS A aprt <1 A aprt >1 TIB p r.3 (MPa) 2.10 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) 4.8 d eq (Z sp ) (cm) F c (MHz) A aprt X (cm) Y (cm) PD (μsec) PRF (Hz) 505 p max (MPa) 2.92 d max (cm) FL x (cm) I max (W/cm 2 ) 184 FL y (cm) TCD 2 /THI CVD/ CVD/ CVD/ 3 2D // /10 cm/ /7.5 cm/ TIC /16 cm/ 4 /PRF /300 /3125 /5208 5/ / / / (a) <1 (b) # / 170

179 10-32 Ispta.3 TI TI MI TIS TIB TIC Aaprt Pr.3 Wo W.3(z1) ISPTA.3(z1) z1 zbp mw/cm 2 MI W/cm 2 TIS TIS TIB - cm 2 MI mw TIS scan z 1 mw z 1 / min(w.3 (z), I TA.3 (z) x 1 cm 2 )] z > zbp cm ( ) 1.69 Aaprt cm zsp MI p r.3 TIB TIB z sp = z b.3 cm deq(z) z ( 4 ( π) )(( Wo) ( ITA( z) )), I TA (z) z cm fc Aaprt MHz (x) (y) cm 171

180 10-32 PD PRF p deq@piimax FL MI MI Hz (x) (y) Output Display Standard % 95% Pr 1.9% +11.2% Pr.3 1.9% +12.2% Wo 3.4% +10% fc 0.1% +4.7% PII 3.2% % PII.3 3.2% % 172

181 Recommended Ultrasound Terminology, Second Edition (American Institute of Ultrasound in Medicine AIUM) 1997 in situ LCD MI/TI NTSC PAL (MI) (TI) (National Television Standards Committee) PAL NTSC SonoHD2 2D 2D SonoMB Steep Needle Profiling (bone thermal index, TIB) (MI) (ALARA) 2D 2D MI MI

182 (cranial bone thermal index, TIC) (skinline) (TI) (soft tissue thermal index, TIS) (phased array transducer) / C (60) rc60xi 1 C TI / L (38) L38xi rp19x 174

183 A A PG A/B "A" "A" A /B A2Cd A2Cs A4Cd A4Cs AAA AAo abs ACC ACS Adur AI AI PHT Ann D ANT F ANT N Ao AoD Apical AT "A" 175

184 AUA AV AV AVA BA Bifur BP BPD BPM Bre BSA CCA CI CM CO CPD CW CxLen D D Apical DCCA DECA DICA AUA OB 176

185 Dist dp:dt E E PG E:A E/e' : "E" "E" E-A E = E e' ECA ECICA ECVA EDD by AUA EDD by LMP LMP EDV EF EF:SLOPE EFW Endo Endo Th Epi EPSS Estab.DD ET E-F EFW EFW "E" LMP LMPd 177

186 FM GA by LMP GA by LMPd Gyn HL HR IVRT IVS IVSd IVSFT IVSs LA LA/Ao Lat V LMP LMPd LV LV LV LV Volume LVd SO (LMP) Estab. DD (LMPd) / EDD Estab. DD 178

187 LVD LVDd LVDFS LVDs LVEDV LVESV LVET LVO LVOT LVOT LVOT D LVOT VTI LVPW LVPWd LVPWFT LVPWs LVs MB SonoMB MI MM MR PISA MR/VTI Msk MV MV M / 179

188 MV MV MV/VTI MVA MV ERO MV PISA MV Neo Nrv NTSC OB Oph / P. PGmax PGmean PGr PHT PI PICA PISA PRF PSV PV PW Qp/Qs 180

189 RA () RI RVD RVDd RVDs RVOT D RVOT VTI RVSP RVW RVWd RVWs S/D / SI SmP Sup SV TAM TAP TCD TDI THI TI TRmax TV TVA 181

190 UA VA VArty Vas Vmax Vmean VTI YS 182

191 SII C11x L25x ICTx HFL38xi HFL50x P10x HSL25x rc60xi L38xi rp19x rc60xi L38xi rp19x / FUJIFILM SonoSite, Inc th Drive SE, Bothell, Washington, 98021, United States th Drive SE, Bothell, Washington, 98021, United States

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