NanoMaxx_UG_SCH_P book

Transcription

1 NanoMaxx 0086

2

3 NanoMaxx Nanomaxx USB USB 2D M C60n, L25n, L38n, P21n, C11n, ICTn YZB/USA

4 / FUJIFILM SonoSite, Inc th Drive SE Bothell, WA USA EC Authorized Representative FUJIFILM SonoSite B.V. Joop Geesinkweg AB Amsterdam, The Netherlands Australian Sponser FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE, NSW 2100 Australia () NanoMaxx, SiteLink, SonoCalc, SonoHD, SonoMB, SonoSite, and the SonoSite logo are registered trademarks or trademarks of SonoSite, Inc. DICOM National Electrical Manufacturers Association The SonoSite ultrasound system referenced in this document may be covered by one or more of the following U.S. patents: D D D D D D D D D D AU AU CA CA CN ZL CN ZL CN ZL CN ZL DE DE DE DE DE DE DE FR FR FR FR FR FR GB GB GB GB GB GB IT IT IT IT KR KR NO NO NZ RCD SP SP SP P / FUJIFILM Sonosite, Inc. ii

5 ...vii...vii USB iii

6 ...13 USB...13 JPEG D...15 M Mode...15 CPD USB IMT OB IMT...25 OB iv

7 ALARA...44 ALARA MI TI MI TI IMT...69 OB v

8 EMC HIPAA vi

9 NanoMaxx NanoMaxx SonoSite 1 6 SonoSite SonoSite SonoSite SonoSite comments@sonosite.com SonoSite SonoSite service@sonosite.com Resources > Support & Service +44-(0) uk.service@sonosite.com china-service@sonosite.com vii

10 viii

11 1 NanoMaxx Patient 4 Mode 2D USB

12 NanoMaxx USB SonoSite 2 2

13 5 2 V V SonoSite

14 USB USB PC USB PC USB SonoSite USB USB USB USB USB USB USB USB USB USB 1 1 USB USB 13 USB USB USB 1 USB 5 2 USB

15 4 5 Gen MB 13 6 ID cm 1cm 5cm Page x/x 1 2 Ä,ñ Symbols A a Delete < > 3 Next Prev 4 Done 1 5

16 SonoSite Aquasonic 21 CFR SonoSite SonoSite SonoSite SonoSite 31 SonoSite

17 CPD Color (PUBS) (IVF) CPD Color (IUGR) NanoMaxx 1 7

18 8

19 2 1 Options Setup 2 Page Previous Next Page Done Reset Administration 1996 (Health Insurance Portability and Accountability Act, HIPAA) (European Union Data Protection Directive, 95/46/EC) HIPAA Administrator 1 Administration Name Administrator 5 2 Password SonoSite vii SonoSite 3 Login Administrator 2 9

20 User Login 1 Administrator 2 User Login On On Off 1 Administrator 2 User List Administrator 3 User Information Password Confirm 11 Password changes 4 Save 1 Administrator 2 New 3 User Information Name Password Confirm 11 4 User 5 Administration Access 6 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 Administrator 3 Export USB 4 USB Export USB 1 USB 2 Administrator 10

21 3 Import 4 USB Import 5 Restart USB PC 1 Administrator 2 Log Back log.txt USB log.txt 1 USB 2 Log Export 1 2 User Login OK 1 2 User Login Guest 1 2 User Login Password 3 OK (A-Z) (a-z) (0-9) USB 3 USB Export Microsoft Word 1 2 Clear 3 Yes User Login 10 Annotations Annotations Exam 2 Group A B C 2 11

22 3 <New> Text Add Text Rename Delete 5 1 USB 2 Annotations Export USB 3 USB Export USB 1 USB 2 Annotations Import 3 USB Import 4 OK USB Audio, Battery Key click On Off Beep alert On Off Sleep delay Off 5 10 Power delay Off Connectivity 1 2 Connectivity Printer 3 NTSC PAL Connectivity Internal Storage Capacity Alert Date and Time Date 5 Time 24 12

23 Display Information Patient Header 18 Mode Data System Status OB Calculations 26 OB OB Calculations Gestational Age None Presets Depth Markers Type 1 1 Type 2 2 Thermal Index TIS TIB TIC OB TIB TIS Auto save Pat. Form Unfreeze Keep All Text Keep Home Text Clear All Text Keep All Text 17 Presets Calibrate for Touchscreen System Information 30 USB USB Devices USB USB USB USB DICOM AE 1 USB Devices USB Export 2 USB Export USB SiteLink SiteLink DICOM DICOM 3 JPEG JPEG 2 13

24 4 SiteLink Sort By Devices 21 USB USB USB USB USB 4 USB 21 USB 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 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 AE AE PACS USB Devices AE Title AE NanoMAXX DICOM SonoSite USB Devices Include private tags SonoSite NanoMaxx DICOM 14 USB

25 3 22 2D 2D 1 Mode 2D D 16 2D THI MB On MB / MB Off MB Res Gen Pen THI MB On MB MB Off MB SonoMB SonoMB MB 16 M Mode Motion mode (M Mode) is an extension of 2D 2D M-line 1 Mode MMode M 2 M-line 3 2D MMode 15 2D 3 15

26 M Mode 1 M-line MMode Mode MMode M 200 ms 1 4 Slow Med Fast Update M Mode M Mode Update 2D 2D M-line M-Mode CPD (CPD) (Color) CPD Color CPD Color 1 Mode Color CPD CPD (ROI) Color Color cm/s 2 ROI 0.5 cm 1 cm 5cm 13 Auto Gain 1 2D MMode Gain Gain Near 2D Far 2D (Color, CPD) Gain ROI 2 2D Reset 16

27 Freeze Unfreeze ROI 2 ROI 3 ROI 100% 4 SonoSite 2D 11 1 Annotate Text Label 2 Home 17 3 Keyboard 5 Label A x/x B x/x C x/x 11 Back 1 Annotate Text 2 3 Home Set Back 3 17

28 1 Annotate Arrow 2 Rotate Arrow 3 Hide Show Back 1 Annotate Picto Rotate Marker 5 Position U/L / D/L / D/R / U/R / Hide Show Back 2D 28 1 Patient 2 New/End / Done 20 ID D Patient 2 3 Cancel Done 18

29 D Patient 3 New/End / Beep Alert 12 Last, First, Middle ID Accession Gender Date of birth Type 22 LMP, Estab. DD OB LMP Estab. DD LMP Save SonoSite vii SonoSite ID/ BP IMT HR IMT Ethnicity IMT User Institution

30 1 2D Options Review Patient Review 2 List Select All Clear All ID 1 2 Edit 3 OK 1 2 Append 1 2 Review (x/x) 3 (< >) List Done 1 Options Review (x/x) 2 (< >) List Done USB USB USB USB 20

31 Print Print Print Print 1 2 Delete USB USB AE 13 USB 1 Export to USB at end of exam USB 14 2 USB 4 USB USB 4 USB 2, Exp.USB USB 3 USB Include patient information on images USB USB 14 4 Export USB 5 USB Cancel Export 3 21

32 2D Exam Exam Type 18 B M C60n, C11n, L38n, L25n, P21n, ICTn 22

33 4 NanoMaxx IMT IMT CIMT OB 7 1 Calcs 2 (OB) HC AC 3 Save 25 IMT 26 OB 1 2D IMT OB Left/Right / Up/Down / Small/Large / Touch screen 4 23

34 Select Switch A/B A/B 13 2D 1 Calipers A Select 4 5 Caliper B 6 Save M Mode cm 200 ms 1 1 MMode Calipers 2 Select M Mode 23 (M Mode) 1 M Mode Calipers 2 HR 3 Select 23 4 Select 28 (FHR) M Mode Caliper B HR 24

35 Delete Back 22 IMT IMT IMT (CCA) (ICA) IMT IMT 1 2D Calcs 2 Right Left 3 IMT Lat F Lat N Post F Post N Ant F Ant N IMT 4 IMT 26 IMT 5 Save 6 Unfreeze Clear Calc

36 IMT IMT Left/Right / Up/Down / Lumen Adventitia Hide, Show Width Smooth Left/Right / Up/Down / Touch screen lumen- - Touch screen IMT Smooth On (s) 1 2D Calcs 2 Right Left 3 Plaque Plaq 1 Plaq Save 6 Unfreeze Clear Calc OB EFW EDD OB EFW OB OB OB 27 OB 18 26

37 OB HC, AC, FL Hadlock 1 (EFW) b BPD AC FL Hadlock 2 AC FL Hadlock 3 BPD AC Shepard HC/AC Campbell FL/AC FL/BPD Hadlock Hohler a GS Hansmann, Nyberg, Tokyo U. FL/HC Hadlock Q 1, Q 2, Q 3, Q 4 Jeng CRL BPD HC AC FL Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann Hadlock, Hansmann, Tokyo U. Chitty, Hadlock, Hansmann, Osaka, Tokyo U. a. AUA b. (Estimated Fetal Weight) EFW 13 Hadlock EFW OB 1 OB LMP Estab.DD D Calcs HL Jeanty 4 27

38 3 a control First Tri GS, CRL Head BPD, HC Abdomen AC # b c Limbs FL HL AFI Q 1, Q 2, Q 3, Q 4 ( 23 ) Save 1 Options Report Patient Report (FHR) 1 M Mode Calcs 2 FHR 3 Select 23 2 (< >) Done 1 2 Delete 4 5 Save 28

39 5 SonoSite vii SonoSite 10 CPD Color Connectivity 12 Page x/x SonoSite SonoSite vii SonoSite 13 PCBA ARM SonoSite USB C: SonoSite SonoSite 5 29

40 1 2 Enter license key 3 Done SonoSite vii SonoSite (APIC) (FDA) 31 SonoSite vii SonoSite SonoSite 30

41 SonoSite 5 31

42 cm 7 8 SonoSite

43 6 ALARA a,b,c (MSD) MSD MSD MSD MSD d MSD e,f 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 hazard? Journal of Diagnostic Medical Sonography. 3 (1985), c. Smith, C.S., G.W. Wolf, G. Y. Xie, M. D. Smith. Musculoskeletal Pain in Cardiac Ultrasonographers Results of a random survey. Journal of American Society of Echocardiography. (May1997), d. Wihlidal, L.M. and S. Kumar. An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta. International Journal of Industrial Ergonomics. 19 (1997), e. Habes, D.J. and S. Baron. Health Hazard Report University of Medicine and Dentistry of New Jersey. (1999). f. 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),

44 34

45 MSD MSD Class I I BF IPX-7 AP/APG Class I I Class I I V 6 35

46 EN Class I I /BF Canadian Standards Association (CSA) European Norm Harmonized Standards Underwriters Laboratories (UL) safety standards (UL) 8 EN Hospital Only Hospital Grade NanoMaxx / ( Stand (MPSO) 36

47 5 SonoSite SonoSite SonoSite SonoSite SonoSite / SonoSite SonoSite SonoSite / - SonoSite JACHO / AAMI-ES1 NFPA 99 OR IEC IEC IEC (ITE) SonoSite 5 / 6 37

48 0 C 40 C 60 C 6 SonoSite -20 C 60 C SonoSite SonoSite SonoSite 38

49 SonoSite ALARA MI TI SonoSite 0.3 db/cm/mhz - SonoSite (LCD) LCD 6 39

50 IEC :2007 (EMC) EMC (RF) (EMI) EMI EMI EMI EMI EMI EMI EMI IEC EMC SonoSite SonoSite SonoSite SonoSite SonoSite (ESD) ESD ESD 40

51 EMC ns μs,,,;, (di/dt),, 1) 2) 3) (m) (C60n) 1.7 (L25n) 2.4 (C11n) 1.9 (L38n) 1.8 (ICTn) 1.8 (P21n)

52 2 GB GB 4824 A GB / GB IEC GB/T GB/T GB/T GB/T (50/60 Hz) GB/T ± 6 KV ± 8 kv ± 2 kv ± 1 kv / ± 1 kv ± 2 kv <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% U T 3 A/m 3 A/m ± 6 kv ± 8 kv ± 2 kv ± 1 kv / ± 1 kv ± 2 kv <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% 30% 42

53 IEC GB/T GB/T Vrms 150 khz-80 MHz 3 V/m 80 MHz- 2.5 GHz 3 Vrms 3 V/m d=1.2 P d=1.2 P 80MHz-800 MHz d=2.3 P 800 MHz-2.5 HGz P (W) d (m) a b 1 80 MHz 800 MHz 2 a : / [ ] b 150 khz 80 MHz 3 V/m (W) (m) 150 k Hz 80 MHz d=1.2 P 80 MHz 800 MHz d=1.2 P 800 MHz 2.5 GHz d=2.3 P d (m) P (W) 1 80 MHz 800 MHz

54 ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI ALARA EN (ISPTA) 720 mw/cm 2 (MI) (TI) 1.0 MI TI 46 MI TI ALARA MI TI MI TI BS EN :2008: Annex HH HH 44 ALARA

55 PRF Kremkau, Frederick W. Diagnostic Ultrasound:Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). 6 45

56 MI TI MI TI MI TI MI TI MI TI 3 MI C11n C60n L25n L38n P21n Depth MI MI 4 TI TIS TIC TIB CPD Depth Optimize C11n C60n L25n L38n P21n TI TI 46 MI TI

57 MI TI AIUM 5 TI MI TI MI 1.0 2D M Mode CPD/ Color C11n/8-5 MI TIC TIB TIS C60n/5-2 MI TIC TIB TIS L25n/13-6 MI TIC TIB TIS L38n/10-5 MI TIC TIB TIS P21n/5-1 MI TIC TIB TIS MI 1.0 MI 0.1 TI TI TI TI ALARA TI SonoSite AIUM TI

58 MI TI MI 95% MI 95% MI +18% -25% +0.2 TI 95% TI 95% TI +21% -40% dB 3dB MI TI 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 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

59 6 23 C ± 3 C EN C C11n C60n L25n L38n P21n (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 UD3-2004) = [e -(0.23alf) ] = = e = a = (db/cm MHz) 6 49

60 = 0.53 = 0.66 = 0.79 = 0.43 = 0.55 l = cm f = // MHz 0.3 = [e -(0.069lf ) ] 0.3 db/cm MHz 3cm 1dB/cmMHz 50

61 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

62 7 C60n/5-2 2D MI TIC A aprt 1 A aprt >1 1.1 (a) (b) p r.3 (MPa) 1.95 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 5.1 d eq (z sp ) (cm) f c (MHz) 2.86 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.58 PRF (Hz) 4827 p max (MPa) 3.22 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) D 3 Depth 4 THI 5 MB Res 7.8 cm (a) <1 (b) # / TIS TIB 52

63 8 C60n/5-2 TIS M Mode MI TIC A aprt 1 A aprt >1 1.1 (a) (a) (a&b) p r.3 (MPa) 1.81 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 4.7 d eq (z sp ) (cm) # f c (MHz) 2.84 # # # A aprt X (cm) # # # Y (cm) # # # PD (μsec) 0.58 PRF (Hz) 1600 p max (MPa) 2.88 d max (cm) # FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) Abd 2 2D Pen 3 Depth THI 5 MB TIB (a) <1 (b) # / 6 53

64 9 C60n/5-2 CPD/ Color MI TIC A aprt 1 A aprt >1 1.1 (a) (b) p r.3 (MPa) 1.95 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 5.1 d eq (z sp ) (cm) f c (MHz) 2.86 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.58 PRF (Hz) 1249 p max (MPa) 3.22 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) Mode 2 3 2D 4 Depth 5 THI 6 CPD Color Abd/Gyn/ Nrv/OB Pen 7.8 cm (a) <1 (b) # / TIS TIB 54

65 10 L38n/10-5 TIS 2D MI TIC A aprt 1 A aprt >1 1.5 (a) (b) p r.3 (MPa) 3.23 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 0.9 d eq (z sp ) (cm) f c (MHz) 5.07 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.32 PRF (Hz) 5221 p max (MPa) 3.78 d max (cm) FL x (cm) # # FL y (cm) # # I max (W/cm 2 ) Msk/ Nrv 2 2D Pen 3 Depth 4.7 cm 4 MB TIB (a) <1 (b) # / 6 55

66 11 L38n/10-5 M Mode MI TIC A aprt 1 A aprt > (b) p r.3 (MPa) 3.23 W 0 (mw) # [W.3 (z 1 ),I TA.3 (z 1 )] (mw) z 1 (cm) z bp (cm) z sp (cm) 1.6 z@pii.3max 0.9 d eq (z sp ) (cm) 0.21 f c (MHz) # A aprt X (cm) # Y (cm) # PD (μsec) 0.32 PRF (Hz) 5221 p max (MPa) 3.78 d max (cm) 0.20 FL x (cm) 5,54 # FL y (cm) 2.5 # I max (W/cm 2 ) Vas/ Ven Vas/Ven 2 2D Pen Pen Pen 3 Depth 4.7 cm 9.0 cm 4.7 cm 4 MB (a) <1 (b) # / TIS TIB 56

67 12 L38n/10-5 TIS CPD/ Color MI TIC A aprt 1 A aprt > (b) p r.3 (MPa) 3.21 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 0.8 d eq (z sp ) (cm) f c (MHz) # A aprt X (cm) 0.42 # Y (cm) 0.4 # PD (μsec) 0.55 PRF (Hz) p max (MPa) 3.66 d max (cm) FL x (cm) 1.16 # FL y (cm) 2.5 # I max (W/cm 2 ) Mode 2 CPD Color SmP/ Msk CPD Color SmP/ Msk 3 2D Pen Res 4 Depth 2.0 cm 2.0 cm 5 TIB (a) <1 (b) # / 6 57

68 13 P21n/5-1 TIS 2D MI TIC A aprt 1 A aprt >1 1.4 (a) 2.1 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 3.6 d eq (z sp ) (cm) f c (MHz) 1.94 # 1.90 A aprt X (cm) # 0.59 Y (cm) # 1.3 PD (μsec) PRF (Hz) 5556 p max (MPa) 2.39 d max (cm) FL x (cm) # 1.55 FL y (cm) # 5.5 I max (W/cm 2 ) Abd Abd 2 2D Res/ Gen Res/Gen 3 Depth 7.5 cm 4.7 cm 4 THI 5 MB TIB (a) <1 (b) # / 58

69 14 P21n/5-1 TIS M Mode MI TIC A aprt 1 A aprt >1 1.2 (a) 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) 3.5 z@pii.3max 4.9 d eq (z sp ) (cm) 0.84 f c (MHz) 2.26 # A aprt X (cm) # Y (cm) # PD (μsec) PRF (Hz) 800 p max (MPa) 2.7 d max (cm) 0.68 FL x (cm) # FL y (cm) # 5.5 I max (W/cm 2 ) Abd Abd Abd 2 2D Pen Pen Pen 3 Depth 7.5 cm 35 cm 35 cm 4 THI 5 MB TIB (a) <1 (b) # / 6 59

70 15 P21n/5-1CPD/ Color MI TIC A aprt 1 A aprt > p r.3 (MPa) 2.15 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 4.9 d eq (z sp ) (cm) f c (MHz) A aprt X (cm) Y (cm) PD (μsec) 0.85 PRF (Hz) 1126 p max (MPa) d max (cm) FL x (cm) FL y (cm) I max (W/cm 2 ) Mode CPD Color CPD Color (a) <1 (b) # / TIS TIB Color 2 Cardiac Abd 3 2D Pen Pen Gen 4 Depth 4.7 cm 7.5 cm 24 cm 5 THI 6 60

71 16 I SPTA.3 TI TI MI I TIS TIB TIC A aprt P r.3 Wo W.3 (z 1 ) I SPTA.3 (z 1 ) milliwatts/cm 2 MI W/cm 2 TIS TIS TIB cm 2 MI milliwatt TIS z 1 milliwatt z 1 / z 1 [min(w.3 (z), I TA.3 (z) x 1 cm 2 )] z > zbp cm z bp 1.69 Aaprt cm z sp d eq (z) ( ) MI p r.3 TIB TIB z sp = z b.3 cm z ( 4 ( π) )(( Wo) ( ITA( z) )) I TA (z) z cm z@pii.3max fc MHz 6 61

72 16 A aprt PD PRF p max d max FL (x) (y) MI MI Hz cm (x) (y) cm 62

73 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% % 6 63

74 (AC), 93/42/EEC Annex VII 1 IIa IIb III 93/42/EEC LOT CUS CSA ANSI/UL REF 93/86/EEC STERILE EO 64

75 18 (DC) FCC GEL STERILE R 6 65

76 18 SN BF B = F = (UL) RoHS / 66

77 18 CCC LCD WARNING: Connect Only Accessories and Peripherals Recommended by SonoSite SonoSite 6 67

78 68

79 D a b (cm) AIUM < ±2% + 1% < ±2% + 1% < ±2% + 1% a. b. 0.7 db/cm MHz RMI 413a IMT Howard G, Sharrett AR, Heiss G, Evans GW, Chambless LE, Riley WA, et al. Carotid Artery Intima-Medial Thickness Distribution in General Populations As Evaluated by B-Mode Ultrasound. ARIC Investigators. Atherosclerosis Risk in Communities. Stroke. (1993), 24: O Leary, Daniel H., MD and Polak, Joseph, F., MD, et al. Use of Sonography to Evaluate Carotid Atherosclerosis in the Elderly. The Cardiovascular Health Study. Stroke. (September 1991), 22, Redberg, Rita F., MD and Vogel, Robert A., MD, et al. Task force #3 What is the Spectrum of Current and Emerging Techniques for the Noninvasive Measurement of Atherosclerosis? Journal of the American College of Cardiology. (June 4, 2003), 41:11,

80 OB (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 = 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), 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), (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 (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. SonoSite 20.0 cm 30.0 cm (AC) AC AC 70

81 (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. (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),

82 72

83 8 C11n/8-5 MHz (1.8 m) C60n/5-2 MHz (1.7 m) L25n/13-6 MHz (2.3 m) L38n/10-5 MHz (1.7 m) P21n/5-1 MHz (1.8 m) 2D 256 M Mode Color power Doppler (CPD) 256 Color Doppler (Color) 256 EN Sony C 15 95% R.H hPa (3.1 m) V C 15 95% R.H hPa C, 15 95% R.H hPa V AC, 50Hz, 2.0A #1 15V 5.0 A #2 12V 2.3 A 75 W 8 73

84 45 EN :2003, European Norm, Medical Electrical Equipment Part 1. General Requirements for Safety. EN :2001, European Norm, Medical Electrical Equipment Part 1. General Requirements for Safety Section 1-1. Collateral Standard. Safety Requirements for Medical Electrical Systems. EN :2008, European Norm, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. CAN/CSA C22.2, No M90: 2002, Canadian Standards Association, Medical Electrical Equipment Part 1. General Requirements for Safety (including CSA Supplement 1:1994 and CSA B-90:2002). CEI/IEC 61157:2007, International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment. UL (1st Edition), Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety. EMC EN :2007, European Norm, Medical Electrical Equipment.General Requirements for Safety-Collateral Standard.Electromagnetic Compatibility. Requirements and Tests. CISPR11:2004, International Electrotechnical Commission, International Special Committee on Radio Interference.Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement. Group 1, Class A 1 A RTCA/DO-160E:2004, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. HIPAA The Health Insurance and Portability and Accountability Act, Pub.L. No (1996). 45 CFR 160, General Administrative Requirements. 45 CFR 164, Security and Privacy. 74

85 Recommended Ultrasound Terminology, Third Edition (American Institute of Ultrasound in Medicine, AIUM) LCD MI/TI NTSC PAL SonoHD (MI) (thermal index, TI) (National Television Standards Committee) PAL NTSC 2D 2D SonoMB TIB 2D 2D TIC TIS (MI) (ALARA) (skinline) MI MI 6 / 75

86 (curved array transducer) (thermal index, TI) (linear array transducer) (phased array) (in situ) C ( 60) C11n C60n 1 C TI / L 38 L38n 76

87 Abd AC AFI BPD Crd CRL FHR FL Gen GS HC HL IMT MB (Abdomen) (Abdominal Circumference) (Cardiac) (Crown Rump Length) (Fetal Heart Rate) (Femur Length) (Gestational Sac) (Head Circumference) (Intima Media Thickness) SonoMB MI Msk Nrv Pen Plaq Q Res SmP Sup (Plaque) 77

88 THI TI Tri Vas Ven LMP Estab. DD 78

89 2D 15 Administrator 9 AE DICOM 14 ALARA 44, 75 CIMT 23 Color (Color) CPD (CPD) DICOM 13 EMC 74 Guide 17 HIPAA 74 IMT 25 M-line 15 NTSC 75 PAL 75 SiteLink 13 SonoHD 75 SonoMB 15, 75 USB 4 13, 21 A B EMC 74 HIPAA C 69 (Color) 16 (CPD) , , 23, D

90 USB Devices USB Administrator E 7 F G 29 H , , J 74 (MI) 48, vii IMT vii IMT K 23, 24 vii L 18 80

91 M 10, 11 5, 13 9 P Q R (thermal index, TI) 13, 48, S M Mode , (in situ) T USB W , X ,

92 Y 2, vii 6 15 (EDD) 70 (EFW) Z vii

93

94 P *P *