SII_UG_CHT_P book

Transcription

1 USER GUIDE

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 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 ; AU ; CA 2,371,711; CA 2,372,152; CA 2,373,065; CN ; CN ; CN ; CN ; CN ; EP ; EP ; EP ; EP P ; EP ; EP ; EP ; JP ; JP ; KR ; KR P FUJIFILM SonoSite, Inc. ii

3 USB iii

4 USB JPEG M Steep Needle Profiling iv

5 M MSK (Gyn) MSK v

6 Spaulding vi

7 EMC DICOM HIPAA ALARA ALARA MI TI vii

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

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

10 FUJIFILM SonoSite

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

12 USB 2-1 USB RJ45 HDMI

13 USB HDMI HDMI

14 FUJIFILM SonoSite 2-4

15 FUJIFILM SonoSite

16 SonoSite SII

17 1 2 USB USB PC USB USB PC USB USB USB USB USB USB USB USB USB USB USB USB USB USB FAT

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

19

20 SonoSite SII

21 2-4 (ROI) M Select 2-11

22 2-5 SonoSite SII 2-12

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

24 21 CFR FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 8-1 FUJIFILM SonoSite Aquasonic

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

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

27 USB - USB 3-12 USB 1 Settings 2 Settings Pages 3 Done 3-1

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

29 User Login 1 2 User Login On On Off 1 Administrator 2 User List Administrator 3 a User Information Password b Confirm 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

30 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

31 1 USB 2-7 USB 2 Administrator 3 Import 4 USB Import 5 Restart USB PC User Login OK 1 2 User Login Guest 1 2 User Login Password 3 OK 3-5

32 (A-Z) (a-z) (0-9) Annotations 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

33 Annotations Unfreeze Keep All Text Keep Home Text Clear All Text Keep All Text 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

34 Off Off Off Off 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

35 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

36 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

37 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

38 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

39 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

40 "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 doi: / /39/9/008 "Canadian Association of Radiologists, CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology," Approved: June

41 SonoSite SII (LCD) D 2 More Controls 4-1

42 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

43 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 M 4-3

44 4 M 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

45 4-3 Flow Sensitivity PRF Scale Invert Steering Wall Filter Variance Flow Low Flow Med Flow High PRF PRF PRF Scale Flow Sensitivity Steering WF Low WF Med WF High 4-5

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

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

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

49 4-4 SNP L25x / L38xi / SNP 4-1 SNP

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

51 Steep Needle Profiling

52 4-5 (Oph) FDA Oph 1 Transducer 2 Switch 4-12

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

54 4-5 a 2D b CPD c Color c HFL38xi / HFL50x HSL25x ICTx 4-14

55 4-5 a 2D b CPD c Color c L25x / L38xi / P10x P11x d rp19x / 4-15

56 3-6 1 Label 2 Text A B C Done 1 Label 2 Arrow Done 4-16

57 1 Label 2 Picto 3 X/X U/L / D/L / D/R / U/R / 7 Done Patient 2 End Done

58 a USB ID USB Auto save Pat Form On Patient 2 Information Done Cancel Patient 3 Information 4 End 4-18

59 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

60 Weight BSA LMP Estab.DD LMP Estab.DD OB Gyn Reading Dr. Referring Dr. Institution Department ID Beep Alert

61 3-11 FUJIFILM SonoSite Patient 2 Review List Select All USB Clear All USB 4-21

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

63 1 USB 2 Patient Review 3 List Image Gallery 4 Select USB USB 5 USB Select 6 USB USB USB USB

64 USB USB 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

65 6-1 5 M HR

66 1 Calipers 2 Ellipse Trace Delete 5-2

67 Calcs

68 5-1 1 Calipers A 2 3 cm 2 cm 1 Calipers 2 Ellipse 3 5-4

69 4 1 Calipers 2 Trace Undo 6 Set M M / (HR)/ (bpm) 200 M 1 M Calipers

70 M 1 M Calipers 2 Heart Rate Save Heart Rate 5-20 M M Add Caliper B C Heart Rate

71 5-20 (...) 1 Calcs Next Previous Save Calc 5 Back Back Calipers Calcs Save Save Calc 5-7

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

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

74 4-17 A 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

75 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 / Save Calcs 6 7 Back 5-11

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

77 d Set e Save Calc 4 LV mass LV Apical 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

78 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

79 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

80 (Gyn) (Gyn) 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

81 EFW EDD EFW A

82 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

83 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 CxLen YS 1 OB LMP Estab.DD 2 Calcs 5-19

84 3 a b 5-1 c Save Calc 4 5 Back M 1 M Calcs 2 FHR Save Calc 6 7 Back (###) A

85 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

86 3 x/x Comments 4 Save 5 MSK Done 5-22

87

88 6-1 2D a b (cm) < ±2% + 1% 0-26 cm < ±2% + 1% 0-35 cm < ±2% + 1% 0-44 cm c < ±4% + ( 2%/) * % cm 2 d < ±3% + ( 1.4%/) * % cm a b 0.7 db/cm MHz RMI 413a c % = ((1 + ) * (1 + ) - 1) * % d % = ( 2 (2 ) * 100) + 0.5% AIUM 6-2

89 (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 = 6-3

90 (EF) Oh, J. K., J. B. Seward, & A. J. Tajik. The Echo Manual. 3rd ed. Philadelphia: Lippincott Williams & Wilkins, (2007), 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 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: 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

91 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), LV = 1.04 [(LVID + PWT + IVST) 3 - LVID 3 ] * LVID = PWT = IVST = 1.04 = 0.8 = 6-5

92 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

93 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), SI = SV/BSA SV = BSA = 6-7

94 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), (AUA) AUA (AUA) (EDD) / / EDD = + (280 - AUA ) (LMP) (EDD) LMP / / EDD = LMP

95 (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 (Estab.DD) (LMPd) (GA) (Estab.DD) (GA) LMP GA(LMPd) = - LMPd (Estab.DD) (LMPd) / / LMPd(Estab.DD) = Estab.DD

96 (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), 885. (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),

97 (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), (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

98 (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), 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),

99 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),

100 6-14

101 7 FUJIFILM SonoSite LCD 2 3 CPD Color OB OB 7-1

102 1 Connectivity C: FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite

103 7-1 ARM PCBA PCBA 1 2 Enter license number 3 Done FUJIFILM SonoSite Done SonoSite SII FUJIFILM SonoSite

104 8-1 FUJIFILM SonoSite 7-4

105 FUJIFILM SonoSite (PPE) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 8-1

106 FUJIFILM SonoSite (FDA) A B 8-8 Spaulding Spaulding Spaulding

107 A (PPE) FUJIFILM SonoSite 8-3

108 a 8-2/ / a SaniCloth AF3 b SaniCloth Plus PI-Spray II a b b c d e 8-4

109 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 b c d 8-5

110 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 o C 12 Revital-OX Resert C35x 20 o C 8 a b P11x c L52x b c d 11 a FUJIFILM SonoSite 8-6

111 b 5 cm 5 cm a 1 b cm c FUJIFILM SonoSite 8-7

112 B A 8-3 (PPE) FUJIFILM SonoSite

113 5 a 8-5/ / a SaniCloth AF3 b SaniCloth Plus PI-Spray II a b 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 8-9

114 b c d FUJIFILM SonoSite 1 2 x 0 o C +45 o C 8-10

115 1 ISO

116 FUJIFILM SonoSite FUJIFILM SonoSite o C +65 o C SonoSite SII

117 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),

118 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),

119 MSD MSD 9-3

120 I BF IPX-7 I I I IPX-8 AP/APG SonoSite SII EN Class I I / Type BF BF

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

122 7-1 / 0 40 C 60 C 2 6 FUJIFILM SonoSite

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

124 IEC :2001 (EMC) s FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 9-11 EMC RF (EMI) EMI EMI EMI EMI EMI EMI EMI IEC EMC 9-8

125 SonoSite SII IEEE GHz ISM IEEE b 16 db (CCK) (DQPSK) (DBPSK) IEEE g 13 dbm (ODFM) (ESD) ESD ESD ESD ESD ESD 1 ESD ESD ESD ESD IEC d 9-9

126 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 (d) P (W) 80 MHz 800 MHz 9-10

127 FUJIFILM SonoSite SonoSite SII IEC :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

128 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 ClSPR 11 1 SonoSite SII RF 9-12

129 9-3 - ClSPR 11 IEC / IEC A A SonoSite SII IEC (ESD) IEC ± 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 ± 2 KV ± 1 KV ± 2 KV ± 1 KV IEC ±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

130 9-4 - IEC IEC <5% U T U T >95% % 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% % 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 RF IEC 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

131 9-4 - IEC IEC V/m 80 MHz 2.5 GHz 3 V/m a b IEC 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

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

133 9-5 LOT "C" "US" CSA ANSI/UL REF 93/86/EEC STERILE EO (DC) 9-17

134 9-5 # # FCC GEL STERILE R SN 9-18

135 9-5 SonoSite SII BF B = F = RoHS / / CCC 9-19

136 cm 151 cm cm 28.7 cm 12.2 cm 5.7 kg 26.1 kg 9-20

137 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

138 PDAS Image Manager (3.1 m) EN USB Sony Kensington C 15 95% hpa ATM C 15 95% hpa

139 C 15 95% R.H hpa ( ATM) VAC 50/60 Hz A # VDC 5.0 A # VDC 2.3 A 75 W 9-7 ANSI/AAMI ES :2005/(R) 2012 A1:2012 CAN/CSA C22.2 No : IEC : IEC :2007 IEC :2013 JIS T0601-1:

140 EMC 9-8 EMC IEC :2007 CISPR 11: (ISM) - 1 A AAMI/ANSI/ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing (2009) AAMI/ANSI/ISO : (2009) AAMI/ANSI/ISO , Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity (2009) AAMI/ANSI/ISO In Vitro (2009) AAMI/ANSI/ISO , Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (2014) AAMI/ANSI/ISO (2002) AAMI/ANSI/ISO , Biological evaluation of medical devices Part 11: Tests for systemic toxicity (2006) AAMI/ANSI/ISO (2006) AAMI/ANSI/ISO , Biological evaluation of medical devices Part 12: Sample preparation and reference materials (2012) AAMI/ANSI/ISO (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 B.118 DICOM DICOM SonoSite Edge II SonoSite SII DICOM

141 HIPAA HIPAA The Health Insurance Portability and Accountability Act, Pub.L.No (1996) CFR 160, General Administrative Requirements 45 CFR CFR 164, Security and Privacy 45 CFR

142 9-26

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

144 EN (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 :2001 HH PRF 10-2

145 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

146 10-1 MI ICTx L25x / L38xi / P10x rp19x / MI MI 10-2 TI PRF C8x C11x C35x rc60xi / TI TI 10-4

147 10-2 TI PRF HFL38xi / HFL50x HSL25x ICTx L25x / L38xi / P10x rp19x / TI TI 10-5

148 MI TI AIUM TI MI 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 MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI

149 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 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% db -3 db MI TI

150 10-47 MI TI / / 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

151 (23 C ± 3 C) EN P11x P11x P11x P11x 10-4 ( C) C11x C35x rc60xi HFL38xi HFL50x HSL25x L25x L38xi P10x rp19x ( C) C8x ICTx (AIUM) - Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement) Stowe (Stowe Report) (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

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

153 0.3 db/cm MHz 3 1dB/cmMHz 1990 MI MI 2.0 M MI C 1.5 C 7 C I SPTA 500 mw/cm 2 Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) TI MI * P11x P11x P11x P11x C8x C8x CPD/ C8x M Mode

154 C35x rc60xi / rc60xi / CPD/ rc60xi / M HFL38xi / HFL38xi / M HFL38xi / CPD/ HFL38xi HFL38xi M HFL38xi M HFL50x HFL50x M Mode HFL50x CPD/ HSL25x HSL25x CPD/ HSL25x HSL25x M HSL25x CPD/ L25x / L25x / CPD/ L25x L25x M L25x CPD/ L38xi / L38xi / M L38xi / CPD/ P10x CPD/ rp19x / rp19x / M rp19x / CPD/

155 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) PRF (Hz) 9524 p max (MPa) 3.11 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) MB (a) <1 (b) # - / TIC 10-13

156 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) PRF (Hz) 2548 p max (MPa) 3.63 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) CVD 3 2D / / / / 5 / / (a) <1 (b) # - / TIC 10-14

157 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) PRF (Hz) 800 p max (MPa) 3.83 d max (cm) # FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) (a) <1 (b) # - / TIC 10-15

158 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) PRF (Hz) 1021 p max (MPa) 2.61 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) MB cm N/A (a) <1 (b) # - / TIC 10-16

159 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) PRF (Hz) 3584 p max (MPa) 3.29 d max (cm) FL x (cm) # # I max (W/cm 2 ) 356 FL y (cm) # # cm 4 MB 5 THI (a) <1 (b) # - / TIC 10-17

160 10-11 rc60xi / M.I. CPD/ 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 4/ 5 / / 11 cm/ /342 / - / 4.7 cm/ /3125 / - (a) <1 (b) # - / TIC 10-18

161 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) PRF (Hz) 800 p max (MPa) 3.25 d max (cm) 0.49 FL x (cm) # # I max (W/cm 2 ) 290 FL y (cm) # # cm 9.2 cm 4 THI (a) <1 (b) # - / TIC 10-19

162 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) PRF (Hz) 2127 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) 494 FL y (cm) # # cm 4 MB N/A 5 (a) <1 (b) # / TIC 10-20

163 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) PRF (Hz) 1600 p max (MPa) 4.35 d max (cm) # FL x (cm) # # I max (W/cm 2 ) FL y (cm) # # 4.0 cm (a) <1 (b) # / TIC 10-21

164 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) PRF (Hz) 2223 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4// 5 / FL y (cm) # # CVD / 3.3 cm /401 / (a) <1 (b) # - / TIC 10-22

165 10-16 HFL38xi M.I. TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.88 # Y (cm) 0.40 # PD (μsec) PRF (Hz) p max (MPa) 0.70 d max (cm) FL x (cm) 2.65 # FL y (cm) 2.44 # I max (W/cm 2 ) cm 4.9 cm 4 MB (a) <1 (b) # - / TIC 10-23

166 10-17 HFL38xi M.I. M TIS A aprt <1 A aprt >1 TIB (b) p r.3 (MPa) 0.44 W 0 (mw) # [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) # A aprt X (cm) # Y (cm) # PD (μsec) PRF (Hz) 800 p max (MPa) 0.55 d max (cm) 0.12 FL x (cm) 2.00 # FL y (cm) 2.44 # I max (W/cm 2 ) cm 6.0 cm 4.0 cm (a) <1 (b) # - / TIC 10-24

167 10-18 HFL38xi M.I. M TIS A aprt <1 A aprt >1 TIB (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) # A aprt X (cm) 0.76 # Y (cm) 0.40 # PD (μsec) PRF (Hz) 4537 p max (MPa) 0.46 d max (cm) FL x (cm) 2.65 # FL y (cm) 2.44 # I max (W/cm 2 ) CVD CVD 3 2D / / 1.5 cm / 4.9 cm 4/ /7813 / / / / (a) <1 (b) # - / TIC 10-25

168 10-19 HFL50x 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) # # I max (W/cm 2 ) 493 FL y (cm) # # MBe (a) <1 (b) # - / TIC 10-26

169 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) PRF (Hz) 1600 p max (MPa) 4.35 d max (cm) # FL x (cm) # # I max (W/cm 2 ) 388 FL y (cm) # # (a) <1 (b) # - / TIC 10-27

170 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) PRF (Hz) 8233 p max (MPa) 3.81 d max (cm) FL x (cm) # # I max (W/cm 2 ) / 4 FL y (cm) # # /3.3 (a) <1 (b) # - / TIC 10-28

171 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) PRF (Hz) 1061 p max (MPa) 3.39 d max (cm) FL x (cm) # # I max (W/cm 2 ) 478 FL y (cm) # # 1 / / / MBe (a) <1 (b) # - / TIC 10-29

172 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) PRF (Hz) 3079 p max (MPa) 2.78 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4// 5 / FL y (cm) # # CVD / 3.1 cm /401 / (a) <1 (b) # - / TIC 10-30

173 10-24 HSL25x 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 ) 13.4 FL y (cm) 2.70 # cm 4.3 cm 4 MB (a) <1 (b) # - / TIC 10-31

174 10-25 HSL25x M.I. M 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 # I max (W/cm 2 ) 14.9 FL y (cm) 2.70 # cm 4.3 cm 4.3 cm (a) <1 (b) # - / TIC 10-32

175 10-26 HSL25x M.I. CPD/ 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 ) 7.5 FL y (cm) 2.70 # 1 2 CVD CVD 3 2D / / 1.9 cm / 5.1 cm 4/ /401 / / / / - (a) <1 (b) # - / TIC 10-33

176 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) PRF (Hz) 1061 p max (MPa) 3.39 d max (cm) FL x (cm) # # I max (W/cm 2 ) 478 FL y (cm) # # 1 / / / MBe (a) <1 (b) # - / TIC 10-34

177 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) PRF (Hz) 5261 p max (MPa) 2.78 d max (cm) FL x (cm) # # I max (W/cm 2 ) D / 4/ 5 / FL y (cm) # # CVD / 3.1 cm /779 / (a) <1 (b) # - / TIC 10-35

178 10-29 L25x 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 ) 13.4 FL y (cm) 2.70 # cm 4.3 cm 4 MB (a) <1 (b) # - / TIC 10-36

179 10-30 L25x M.I. M 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 # I max (W/cm 2 ) 14.9 FL y (cm) 2.70 # cm 4.3 cm 4.3 cm (a) <1 (b) # - / TIC 10-37

180 10-31 L25x M.I. CPD/ 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 ) 7.5 FL y (cm) 2.70 # 1 2 CVD CVD 3 2D / / 1.9 cm / 5.1 cm 4/ /401 / / / / - (a) <1 (b) # - / TIC 10-38

181 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) PRF (Hz) 1312 p max (MPa) 3.79 d max (cm) FL x (cm) # # I max (W/cm 2 ) MB 5 FL y (cm) # # 2.0 cm N/A (a) <1 (b) # - / TIC 10-39

182 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) PRF (Hz) 1600 p max (MPa) 4.32 d max (cm) 0.49 FL x (cm) # # I max (W/cm 2 ) 776 FL y (cm) # # cm 7.3 cm (a) <1 (b) # - / TIC 10-40

183 10-34 L38xi / CPD/ TIS TIB M.I. TIC A aprt < A 1 aprt > (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 2 CVD CVD 3 2D / 4/ / 2.0 cm /393 / 3.1 cm / / / / - (a) <1 (b) # - / 10-41

184 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 max (MPa) # d max (cm) FL x (cm) # 6.74 I max (W/cm 2 ) # D // 4/ 5 / TIC FL y (cm) # 5.00 CVD / 8.9 cm/ /2033 / - (a) <1 (b) # - / 10-42

185 10-36 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 TIC FL y (cm) cm 10 cm 4.7 cm 4 MB/THI / / / 5 N/A N/A (a) <1 (b) # - / 10-43

186 10-37 rp19x / M.I. M 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 cm 10 cm 16 cm 4 THI (a) <1 (b) # - / 10-44

187 10-38 rp19x / TIS CPD/ TIB M.I. TIC A aprt <1 A aprt > 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/n/a / 7.5 cm/n/a / 16 cm/ 4/ /300 /3125 / / / / / (a) <1 (b) # - / 10-45

188 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

189 10-39 p deq@piimax FL (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% % 10-47