產品資訊與安全手冊

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2 FUJIFILM SonoSite, Inc th Drive SE Bothell, WA Emergo Europe Molenstraat BH, The Hague FUJIFILM SonoSite Australasia Pty Ltd Suite 9, 13a Narabang Way Belrose, New South Wales 2085 X-Porte SonoSite SonoSite FUJIFILM SonoSite, Inc FUJIFILM SonoSite, Inc. P c

3 X-Porte ALARA...23 ALARA (MI) (TI) iii

4 EMC DICOM HIPAA iv

5 X-Porte X-Porte FUJIFILM SonoSite 4 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite service@sonosite.com 5

6 FUJIFILM SonoSite FUJIFILM SonoSite - Amsterdam Science Park XH Amsterdam SonoSite Singapore Pte Ltd 10 New Industrial Road #02-00 Fujifilm Building Singapore

7 1 (MSD) 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, and 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),

8 MSD 8

9 MSD Class I I I I I BF CF IPX-7 IPX-8 AP/APG ECG ECG EN Class I I / Type BF BF Type CF CF ECG Canadian Standards Association CSA European Norm Harmonized Standards Underwriters Laboratories (UL) safety standards (UL) 3 1 9

10 Hospital Only Hospital Grade ECG (TTC) TTC TTC (MPSO) 5 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite / FUJIFILM SonoSite JACHO / AAMI-ES1 NFPA 99 IEC IEC IEC (ITE) IEC

11 FUJIFILM SonoSite X-Porte Power X-Porte Power Power X-Porte 1 11

12 X-Porte / 1948 FUJIFILM SonoSite ALARA MI TI FUJIFILM SonoSite 0.3 db/cm/mhz FUJIFILM SonoSite 12

13 P21xp P21xp IEC :2007 EMC FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite

14 EMC (RF) (RF) (EMI) EMI EMI EMI EMI EMI EMI EMI IEC EMC X-Porte IEEE GHz GHz ISM IEEE a GHz 11 dbm Mbps (OFDM) IEEE b GHz 16 dbm Mbps (DSSS) IEEE g GHz 13 dbm Mbps (OFDM) IEEE n GHz GHz 10 dbm dbm (802.11an) 12 dbm dbm (802.11gn) (OFDM) 14

15 (ESD) ESD ESD ESD ESD ESD (TTC) ( ) ESD ESD ESD ESD IEC d 1 15

16 RF X-Porte X-Porte (RF) X-Porte RF X-Porte khz 80 MHz 80 MHz 800 MHz 800 MHz 2.5 GHz d=1.2 P d=1.2 P d=2.3 P (d) (W) 80 MHz 800 MHz FUJIFILM SonoSite X-Porte IEC :2007 FUJIFILM SonoSite X-Porte X-Porte 16

17 2 X-Porte L25xp L38xp P21xp ICTxp HFL50xp C60xp DVR USB (64 GB) - ECG 0.6 / 0.6 ECG Kensington Power Park - - SPMU

18 2 X-Porte USB (16 GB) - USB (32 GB) - USB (64 GB)

19 3 4 EMC 3 - ClSPR 11 1 X-Porte RF ClSPR 11 A X-Porte IEC A / IEC

20 4 - IEC (ESD) IEC ± 2.0KV ± 4.0KV ± 6.0KV ± 2.0KV ± 4.0KV ± 8.0KV ± 2.0KV ± 4.0KV ±6.0KV ± 2.0KV ± 4.0KV ±8.0KV 30% IEC ± 2KV ± 1KV ± 2KV ± 1KV IEC ±1KV ± 2KV ±1KV ± 2KV IEC <5% U T U T >95% % U T U T 60% 5 70% U T U T 30% <5% U T U T >95% % U T U T 60% 5 70% U T U T 30% FUJIFILM SonoSite FUJIFILM SonoSite 25 <5% U T 25 <5% U T U T >95% U T >95% 5 5 IEC / 3 / FUJIFILM SonoSite 20

21 4 - IEC IEC Vrms 150 khz 80 MHz 3Vrms FUJIFILM SonoSite RF d = 1.2 P IEC / 80 MHz 2.5 GHz 3 / d = 1.2 P 80 MHz 800 MHz d = 2.3 P 800 MHz 2.5 GHz P (W) d (m) a b IEC No. 417-IEC-5140 Source of non-ionizing radiation U T 80 MHz 800 MHz 1 21

22 a. / FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3 / 15 X-Porte IEC IEC X-Porte 22

23 2 ALARA ALARA ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI 2D ALARA EN

24 ALARA (ISPTA) 720 (MI) (TI) 1.0 ISPTA 50 TI 1.0 MI 0.23 MI TI ALARA MI TI BS EN :2001 Annex HH HH MI TI (MI) (TI) 24 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 24

25 1 MI C60xp HFL50xp ICTxp L25xp L38xp P21xp MI MI 2 (TIS) (TIC) (TIB) ALARA (PRF) C60xp HFL50xp ICTxp L25xp L38xp P21xp TI TI 2 25

26 MI TI AIUM 27 3 TI MI TI MI 1.0 2D/ M / C60xp MI - TIC TIB TIS - HFL50xp MI - TIC TIB TIS - ICTxp MI - TIC TIB TIS - L25xp MI - TIC TIB TIS - L38xp MI - TIC TIB TIS - P21xp MI TIC TIB TIS MI MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI 27 26

27 MI 95% 95% MI MI +18% -25% +0.2 TI 95% 95% TI TI +21% -40% dB 3dB MI TI MI TI ALARA 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 NEMA Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine,

28 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD NEMA 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 ( C) C60xp HFL50xp L25xp L38xp P21xp 12.2 C 11.1 C 12.8 C 11.5 C 14.7 C 8.2 ( 10 C) 9.0 ( 10 C) 8.6 ( 10 C) 8.8 ( 10 C) 9.5 ( 10 C) 5 ( C ) ICTxp (<6 C) (bioeffects) 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) 28

29 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) = [e -(0.23alf ) ] = = e = a = (db/cm MHz) = 0.53 ALARA = 0.66 = 0.79 = 0.43 = 0.55 l = f = / / MHz 0.3 = [e -(0.069lf) ] 2 29

30 0.3 db/cm MHz 3 1dB/cmMHz 1990 MI MI 2.0 2D MMode M MI C 1.5 C 7 C I SPTA 500 mw/cm 2 Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) TI MI

31 6 C60xp2D (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 1.3 (a) (b) 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@pll.3max (cm) 4.4 d eq (z sp ) (cm) - f c (MHz) 2.73 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 6027 p max (MPa) 3.26 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) / (MB/THI) FL y (cm) # - - # 9.9 cm / ALARA (a) <1 (b) # / 2 31

32 7 C60xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) (b) p r.3 (MPa) 2.48 W 0 (mw) - # 55.0 # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) 4.90 z@pll.3max (cm) 4.2 d eq (z sp ) (cm) 0.34 f c (MHz) # # A aprt X (cm) - # # Y (cm) - # # (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 3.70 d max (cm) 0.33 FL x (cm) - # - # I max (W/cm 2 ) 392 FL y (cm) - # - # cm 11 cm 4 (THI) (a) <1 (b) # / 32

33 8 C60xp (Color)/ (CPD) (MI) (TIS) (TIB) (TIC) A aprt 1 A aprt > (b) p r.3 (MPa) 1.99 W 0 (mw) # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 4.4 d eq (z sp ) (cm) - f c (MHz) # A aprt X (cm) # Y (cm) # (PD) (μsec) (PRF) (Hz) 2645 p max (MPa) 2.96 d max (cm) - FL x (cm) # FL y (cm) # I max (W/cm 2 ) (Color) (Color) 3 2D / (THI)/ 4 / (PRF) / / 11 cm /3049Hz / / 6.0 cm /414Hz 5 / / / ALARA (a) <1 (b) # / 2 33

34 9 C60xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (b) p r.3 (MPa) 2.44 W 0 (mw) # W.3 (z 1 ),I TA.3 (z 1 )] (mw) 84.1 z 1 (cm) 3.9 z bp (cm) 3.8 z sp (cm) 0.40 z@pll.3max (cm) 1.9 d eq (z sp ) (cm) 0.45 f c (MHz) # A aprt X (cm) # Y (cm) # (PD) (μsec) (PRF) (Hz) 1302 p max (MPa) 2.89 d max (cm) 0.45 FL x (cm) # I max (W/cm 2 ) 239 FL y (cm) # mm 12 mm 12 mm (PRF) 1302 Hz 1302 Hz 2604 Hz (a) <1 (b) # / 34

35 10 ICTxpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) - (a) (b) p r.3 (MPa) 2.46 W 0 (mw) - # # # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) # z@pll.3max (cm) 1.4 d eq (z sp ) (cm) # f c (MHz) # - # # A aprt X (cm) - # - # # Y (cm) - # - # # (PD) (μsec) (PRF) (Hz) 1600 p max (MPa) 3.07 d max (cm) # FL x (cm) - # - # I max (W/cm 2 ) (THI) FL y (cm) - # - # 4.1 cm ALARA a) <1 (b) # / 2 35

36 11 ICTxp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) (b) p r.3 (MPa) 2.01 W 0 (mw) - # 19.8 # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) 1.66 z@pll.3max (cm) 1.4 d eq (z sp ) (cm) 0.20 f c (MHz) # # A aprt X (cm) - # # Y (cm) - # # (PD) (μsec) (PRF) (Hz) 1302 p max (MPa) 2.49 d max (cm) 0.19 FL x (cm) - # - # I max (W/cm 2 ) 263 FL y (cm) - # - # mm 12 mm (PRF) 1302 Hz 1562 Hz (a) <1 (b) # / 36

37 12 L25xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) - (a) (b) p r.3 (MPa) 2.67 W 0 (mw) - # # # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) # z@pll.3max (cm) 0.9 d eq (z sp ) (cm) # f c (MHz) # - # # A aprt X (cm) - # - # # Y (cm) - # - # # (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 3.30 d max (cm) # FL x (cm) - # - # I max (W/cm 2 ) FL y (cm) - # - # 3.5 cm ALARA (a) <1 (b) # / 2 37

38 13 L25xp (Color)/ (CPD) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 1.1 (a) (b) p r.3 (MPa) 2.64 W 0 (mw) # - - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 0.8 d eq (z sp ) (cm) - f c (MHz) 6.11 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 1599 p max (MPa) 3.13 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) FL y (cm) # - - # (CPD) 3 2D / / 2.4 cm 4 / /312 Hz (PRF) 5 / / (a) <1 (b) # / 38

39 14 L25xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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) 1.40 z@pll.3max (cm) # d eq (z sp ) (cm) 0.17 f c (MHz) # # A aprt X (cm) # Y (cm) # (PD) (μsec) # (PRF) (Hz) # p max (MPa) # d max (cm) 0.16 FL x (cm) # I max (W/cm 2 ) # FL y (cm) # 7 mm 4 (PRF) ALARA (a) <1 (b) # / 2 39

40 15 L38xp2D (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 1.5 (a) (b) p r.3 (MPa) 3.32 W 0 (mw) # - - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 1.1 d eq (z sp ) (cm) - f c (MHz) 4.83 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 790 p max (MPa) 4.02 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) MB 5 FL y (cm) # - - # 3.5 cm / a) <1 (b) # / 40

41 16 L38xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (b) p r.3 (MPa) 3.37 W 0 (mw) # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) 1.0 z@pll.3max (cm) 1.2 d eq (z sp ) (cm) 0.62 f c (MHz) # A aprt X (cm) # Y (cm) # (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 4.18 d max (cm) 0.62 FL x (cm) # I max (W/cm 2 ) 538 FL y (cm) # cm 9.0 cm 9.0 cm ALARA a) <1 (b) # / 2 41

42 17 L38xp (Color)/ (CPD) (MI) (TIS) A aprt 1 A aprt >1 (TIB) a) <1 (b) # / (TIC) 1.5 (a) (b) p r.3 (MPa) 3.20 W 0 (mw) # - - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 1.1 d eq (z sp ) (cm) - f c (MHz) 4.63 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 5064 p max (MPa) 3.78 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) FL y (cm) # - - # (Color) 3 2D / / 3.5 cm 4 / (PRF) / 6250 Hz 5 / / - 42

43 18 L38xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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) 1.00 z@pll.3max (cm) 0.3 d eq (z sp ) (cm) 0.43 f c (MHz) # A aprt X (cm) # Y (cm) # (PD) (μsec) (PRF) (Hz) 1562 p max (MPa) 2.33 d max (cm) 0.40 FL x (cm) # I max (W/cm 2 ) 210 FL y (cm) # mm 3 mm 3 mm (PRF) 1562 Hz 1562 Hz 1562 Hz ALARA a) <1 (b) # / 2 43

44 19 HFL50xp2D (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 1.1 (a) (b) p r.3 (MPa) 2.61 W 0 (mw) # - - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 1.3 d eq (z sp ) (cm) - f c (MHz) 5.30 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 1084 p max (MPa) 3.31 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) MB 5 FL y (cm) # - - # 4.8 cm / a) <1 (b) # / 44

45 20 HFL50xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) - (a) (b) p r.3 (MPa) 3.40 W 0 (mw) - # # # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) # z@pll.3max (cm) 1.1 d eq (z sp ) (cm) # f c (MHz) # - # # A aprt X (cm) - # - # # Y (cm) - # - # # (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 4.51 d max (cm) # FL x (cm) - # - # I max (W/cm 2 ) FL y (cm) - # - # 1.9 cm ALARA a) <1 (b) # / 2 45

46 21 HFL50xp (Color)/ (CPD) (MI) (TIS) A aprt 1 A aprt >1 (TIB) a) <1 (b) # / (TIC) 1.1 (a) (b) p r.3 (MPa) 2.62 W 0 (mw) # - - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 1.2 d eq (z sp ) (cm) - f c (MHz) 5.93 # # A aprt X (cm) # # Y (cm) # # (PD) (μsec) (PRF) (Hz) 6649 p max (MPa) 3.35 d max (cm) - FL x (cm) # - - # I max (W/cm 2 ) D / FL y (cm) # - - # CVD /4.0 cm 4 / /7812 Hz (PRF) 5 / / 46

47 22 HFL50xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) (a) 1.5 (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) 1.68 z@pll.3max (cm) # d eq (z sp ) (cm) 0.19 f c (MHz) # # 5.99 # A aprt X (cm) # 0.72 # Y (cm) # 0.40 # (PD) (μsec) # (PRF) (Hz) # p max (MPa) # d max (cm) 0.18 FL x (cm) # # I max (W/cm 2 ) # FL y (cm) # # mm 1 mm (PRF) 1562 Hz 1953 Hz ALARA a) <1 (b) # / 2 47

48 23 P21xp2D (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 1.5 (a) p r.3 (MPa) 2.02 W 0 (mw) # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 4.1 d eq (z sp ) (cm) - f c (MHz) 1.85 # A aprt X (cm) # Y (cm) # (PD) (μsec) (PRF) (Hz) 2933 p max (MPa) 2.63 d max (cm) - FL x (cm) # I max (W/cm 2 ) 240 FL y (cm) # cm 35 cm 4 / (MB/THI) / 5 / a) <1 (b) # / 48

49 24 P21xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (a) p r.3 (MPa) 2.02 W 0 (mw) - # W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) 5.00 z@pll.3max (cm) 4.1 d eq (z sp ) (cm) 0.36 f c (MHz) # A aprt X (cm) - # Y (cm) # (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 2.63 d max (cm) 0.35 FL x (cm) - # I max (W/cm 2 ) 240 FL y (cm) - # cm 11 cm 35 cm 4 (THI) ALARA a) <1 (b) # / 2 49

50 25 P21xp (Color)/ (CPD) (MI) (TIS) A aprt 1 A aprt >1 (TIB) a) <1 (b) # / (TIC) p r.3 (MPa) 2.02 W 0 (mw) W.3 (z 1 ),I TA.3 (z 1 )] (mw) - z 1 (cm) - z bp (cm) - z sp (cm) - z@pll.3max (cm) 4.1 d eq (z sp ) (cm) - f c (MHz) A aprt X (cm) Y (cm) (PD) (μsec) (PRF) (Hz) 800 p max (MPa) 2.63 d max (cm) - FL x (cm) FL y (cm) I max (W/cm 2 ) D / (THI)/ 4 / (PRF) (Color) / / 9.0 cm 5 / / - (Color) / / 5.0 cm /880 Hz / 2500 Hz / (Color) / / 5.0 cm / 2500 Hz / 50

51 26 P21xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) p r.3 (MPa) 2.15 W 0 (mw) W.3 (z 1 ),I TA.3 (z 1 )] (mw) z 1 (cm) 3.1 z bp (cm) 2.8 z sp (cm) 3.90 z@pll.3max (cm) 1.4 d eq (z sp ) (cm) 0.71 f c (MHz) A aprt X (cm) Y (cm) (PD) (μsec) (PRF) (Hz) 1562 p max (MPa) 2.37 d max (cm) 0.49 FL x (cm) I max (W/cm 2 ) 184 FL y (cm) mm 14 mm 14 mm 7 mm (PRF) 1562 Hz 1562 Hz 1562 Hz 1953 Hz 5 (TDI) ALARA a) <1 (b) # / 2 51

52 27 P21xp (CW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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) 1.25 z@pll.3max (cm) # d eq (z sp ) (cm) 0.52 f c (MHz) # A aprt X (cm) Y (cm) (PD) (μsec) # (PRF) (Hz) # p max (MPa) # d max (cm) 0.47 FL x (cm) I max (W/cm 2 ) # FL y (cm) a) <1 (b) # / 52

53 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% % ALARA 2 53

54 54

56 2D 256 (CPD) 256 (Color) 256 M (M Mode) (PW) (CW) (TDI) (THI) C 15 95% hpa C 15 95% hpa V ~ 50/60 Hz 6.0A 56

57 1 IEC :1988 IEC : Amendment A1:2004 Medical Electrical Equipment Part 1. General Requirements for Safety Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment; as applied to IEC :1988, Medical Electrical Equipment Part 1. General Requirements for Safety (2nd Edition including Amendment 1 and 2); including all national differences necessary to meet IECEE CB Scheme certification. IEC : IECEE CB Scheme IEC :2000 IEC :2000 Medical Electrical Equipment Part 1-1. General Requirements for Safety Section 1-1. Collateral Standard.Safety Requirements for Medical Electrical Systems Medical Electrical Equipment Part 1-4. General Requirements for Safety Section 1-4. Collateral Standard. Programmable Electrical Medical Systems EC :2005/A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

58 1 IEC :2007 IEC 61157:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; as applied to IEC :2005/A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (3rd Edition including Amendment 1); including all national differences necessary to meet IECEE CB Scheme certification IEC :2005/A1: IECEE CB Scheme Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment. EMC 2 EMC IEC :2007 CISPR 11:2004 Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests. - Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics- Limits and Methods of Measurement. (ISM) - 1 A 58

59 DICOM NEMA PS 3.15:2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles NEMA PS (DICOM) - 15 DICOM X-Porte DICOM HIPAA HIPAA The Health Insurance and Portability and Accountability Act, Pub.L.No (1996) CFR 160, General Administrative Requirements 45 CFR 164, Security and Privacy 3 59

60 2D D 2D a b < ±2% 1% 0 26 < ±2% 1% 0 35 < ±2% 1% 0 44 c d < ±4% + ( 2% ) * % < ±3% + ( 1.4%/ ) * % a. b. 0.7 db/cm MHz RMI 413a c. % = ((1 + ) * (1 + ) 1) * % d. % = ( 2 (2 ) * 100) + 0.5% 60

61 4 M M < +/- 2% 1% a b 0 26 < +/- 2% 1% c d < +/- 2% + ( c * /100) % d a. b. 0.7 db/cm MHz RMI 413a c. d. FUJIFILM SonoSite 5 a < +/- 2% 1% b < +/- 2% % b < +/- 2% % c a. FUJIFILM SonoSite b. c. 3 61

62 62

63 4 c (AC) 1 93/42/EEC VII 1 IIa IIb III 93/42/EEC LOT C US CSA ANSI/UL REF 4 63

64 93/86/EEC (DC) # # FCC GEL STERILE R STERILE EO 64

65 SN BF B = F = CF (UL) 4 65

66 RoHS / / ( CCC Mark ) WARNING: Connect Only Accessories and Peripherals Recommended by FUJIFILM SonoSite FUJIFILM SonoSite 66

67 5 FUJIFILM SonoSite FUJIFILM SonoSite 5 ON OFF CPD CPD. Color PRF Color Calcs More Controls DICOM DICOM DVR USB C: FUJIFILM SonoSite FUJIFILM SonoSite 5 67

68 USB USB USB USB USB USB USB USB USB USB Incompatible power supply internal storage device is full (DICOM) DICOM Archiver Exclude Video Clips FUJIFILM SonoSite 68

69 1 2 a b MORE System Settings System Information 3 FUJIFILM SonoSite FUJIFILM SonoSite 5 a b c PCBA d System Setup 1 2 Enter license number 3 Done FUJIFILM SonoSite FUJIFILM SonoSite 5 System Settings 1 MORE System Settings 2 System Information 3 System Licensing Scanhead Licensing Enter license key 4 ENTER 5 69

70 X-Porte X-Porte FUJIFILM SonoSite ON FUJIFILM SonoSite FUJIFILM SonoSite 5 X-Porte FUJIFILM SonoSite (DICOM) (LAN) FUJIFILM SonoSite DICOM X-Porte DICOM DICOM FUJIFILM SonoSite USB X-Porte USB FUJIFILM SonoSite presets X-Porte 70

71 USB DICOM Presets DICOM USB 1 2 USB DICOM X-Porte 3 Patient Patient List 4 Select All Delete 5 USB DICOM DICOM DICOM DICOM X-Porte USB ECG 5 71

73 AIUM 1997 Recommended Ultrasound Terminology, Second Edition AIUM (ALARA) C (60) C60xp / LCD (MI) MI/TI SonoMB (TI) TIB L (38) L38xp MI MI 2 (MI) (TI) 2D 2D / 1 C TI 2 73

74 TIC TIS (TDI) Color Doppler 74

75 A aprt d eq (z) z ( 4 ( π) )(( Wo) ( ITA( z) )) I TA (z) z d max A aprt fc FL I I SPTA.3 I SPTA.3 (z 1 ) MI PD P r.3 p max PRF TI TI TIB TIC TIS W.3 (z 1 ) (x) (y) (x) (y) MI / / z 1 / MI MI MI TIB TIS TIS z 1 75

76 Wo z 1 TIS min(w.3 (z), I TA.3 (z) x 1 cm 2 )] z > zbp z bp 1.69 Aaprt ( ) z sp p r.3 z sp = z b.3 76

77 AIUM 73 ALARA 23, 73 DICOM 59 DVD 67 EMC 58 HIPAA 59 LCD 27 SonoMB 73 7, , Color 67, CPD

78 74 DICOM 59 EMC 58 HIPAA (MI) 27, , (TI) 27, , 63, C60xp 2D 31 M 32 (Color)/ (CPD) 33 (PW Doppler) 33, 34 HFL50xp 2D 44 M (M Mode) 45 (Color)/ (CPD) 46 (PW Doppler) 47 ICTxp M (M Mode) 35 (PW Doppler) 36 L25xp M (M Mode) 37 (Color)/ (CPD) 38 (PW Doppler) 38, 39 L38xp M (M Mode) 41 (Color)/ (CPD) 42 (PW Doppler) 43 P21xp 2D 48 M (M Mode) 49 (Color)/ (CPD) 50 (PW Doppler) 51 (CW Doppler) , 75 L38xp 2D , ,

79 ,

80 80

82 P *P *

产品信息和安全指南

产品信息和安全指南 FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA +1-888-482-9449 +1-425-951-1200 +1-425-951-1201 Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands FUJIFILM SonoSite Australasia