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 Pty Ltd Suite 9, 13a Narabang Way Belrose, New South Wales 2085 Australia X-Porte SonoSite SonoSite FUJIFILM SonoSite, Inc. 2013 FUJIFILM SonoSite, Inc. P14670-01 06/2013 c0086

... 5... 5 1... 7... 8... 8... 9... 9... 9 X-Porte...12...13...13...14...14...15...16...17...18...20 2 ALARA...25 ALARA...25...26...26 MI TI...27...28 MI TI...29...29...30...30...31...31...32...32...55 iii

3... 57... 57... 58... 58... 58... 58... 58... 59 EMC... 60 DICOM... 60 HIPAA... 60... 60 4... 63 5... 67... 68... 70... 70... 70... 71... 73... 75 iv

X-Porte X-Porte FUJIFILM SonoSite 4 FUJIFILM SonoSite +1-888-482-9449 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite +1-877-657-8118 +1-425-951-1330 +1-425-951-6700 service@sonosite.com www.sonosite.com 5

FUJIFILM SonoSite FUJIFILM SonoSite - Amsterdam Science Park 402 1098 XH Amsterdam The Netherlands +31 20 751 2020 - +44 14 6234 1151 - +33 1 8288 0702 - +49 69 8088 4030 - +39 02 9475 3655 - +34 91 123 8451 SonoSite Singapore Pte Ltd 10 New Industrial Road #02-00 Fujifilm Building Singapore 536501 +65 6380-5589 6

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), 981-988. b. Craig, M. Sonography:An Occupational Hazard? Journal of Diagnostic Medical Sonography.3 (1985), 121-125. c. Smith, C.S., G.W.Wolf, G. Y. Xie, and M. D. Smith. Musculoskeletal Pain in Cardiac Ultrasonographers:Results of a Random Survey. Journal of American Society of Echocardiography.(May1997), 357-362. d. Wihlidal, L.M. and S. Kumar. An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta. International Journal of Industrial Ergonomics.19 (1997), 205-216. e. Habes, D.J. and S. Baron. Health Hazard Report 99-0093-2749. 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), 605-610. 1 7

8

MSD MSD Class I I BF CF IPX-7 IPX-8 AP/APG Class I I Class I I ECG /ECG EN60601-1 Class I I / BF CF ECG Canadian Standards Association (CSA) European Norm Harmonized Standards Underwriters Laboratories (UL) (UL) 3 1 9

Hospital Only Hospital Grade ECG / (TTC) TTC TTC (MPSO) 5 FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite / 10

FUJIFILM SonoSite JACHO / AAMI-ES1 NFPA 99 IEC 60601-1-1 IEC 60601-1-2 IEC 60950 (ITE) IEC 60601-1 FUJIFILM SonoSite 1 11

X-Porte X-Porte 1 2 X-Porte 3 4 12

X-Porte / 1948 FUJIFILM SonoSite ALARA MI TI FUJIFILM SonoSite 0.3 db/cm/mhz FUJIFILM SonoSite 1 13

P21xp P21xp IEC 60601-1-2:2007 (EMC) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 18 14

EMC (RF) (EMI) EMI EMI EMI EMI EMI EMI EMI IEC 60601-1-2 EMC X-Porte IEEE 802.11 2.412 GHz 2.484 GHz 4.915 5.824 GHz ISM IEEE 802.11a 4.915 5.824 GHz 11 dbm + 1.5 dbm @ 54 Mbps (OFDM) IEEE 802.11b 2.412 2.484GHz 16 dbm + 1.5 dbm @ 11 Mbps (DSSS) IEEE 802.11g 2.412 2.484GHz 13 dbm + 1.5 dbm @ 54 Mbps (OFDM) IEEE 802.11n 2.412 2.484 GHz 4.915 5.824 GHz 10 dbm + 1.5 dbm (802.11an) 12 dbm + 1.5 dbm (802.11gn) (OFDM) 1 15

(ESD) ESD ESD ESD ESD ESD 三联换能器连接 (TTC) 前后的针脚 ( 接触 ) ESD ESD ESD ESD IEC 60601-1-2 5.2.1.2 d 16

RF X-Porte X-Porte (RF) X-Porte RF X-Porte 1 (W) (m) 150 khz 80 MHz 80 MHz 800 MHz 800 MHz 2.5 GHz d=1.2 P d=1.2 P d=2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 (d) (m) P (W) 80 MHz 800 MHz 1 17

FUJIFILM SonoSite X-Porte IEC 60601-1-2:2007 FUJIFILM SonoSite X-Porte X-Porte 2 X-Porte L25xp L38xp P21xp ICTxp HFL50xp C60xp 2.2 m 1.7 m 1.75 m 1.7 m 1.7 m 1.7 m 1.5 m 3 - - - DVR USB (64 GB) - ECG ECG 0.6 m / 0.6 m 1.8 m 1.8 m 1.8 m 3 m 3 m 18

2 X-Porte Kensington 1.8 m Power Park - - SPMU - - 3.1 m - - - USB (16 GB) - USB (32 GB) - USB (64 GB) - - 1.8 m 1.8 m 1.2 m 1 m 1.8 m 0.57 m 1 19

3 4 EMC 3 - RF ClSPR 11 RF ClSPR 11 IEC 61000-3-2 IEC 61000-3-3 Group 1 1 Class A A Class A A X-Porte RF RF X-Porte 20

4 - IEC 60601 (ESD) IEC 61000-4-2 ± 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 61000-4-4 ± 2KV ± 1KV ± 2KV ± 1KV IEC 61000-4-5 ± 1KV ± 2KV ± 1KV ± 2KV IEC 61000-4-11 <5% U T >95% U T 0.5 40% U T 60% U T 5 70% U T 30% U T 25 <5% U T >95% U T 5 <5% U T >95% U T 0.5 40% U T 60% U T 5 70% U T 30% U T 25 <5% U T >95% U T 5 FUJIFILM SonoSite FUJIFILM SonoSite IEC 61000-4-8 3 A/m 3 A/m FUJIFILM SonoSite 1 21

4 - IEC 60601 IEC 61000-4-6 3Vrms 150 khz 80 MHz 3Vrms FUJIFILM SonoSite RF IEC 61000-4-3 3 V/m 80 MHz 2.5 GHz d = 1.2 P 3 V/m d = 1.2 P 80 MHz 800 MHz d = 2.3 P 800 MHz 2.5 GHz P (W) d (m) RF a b IEC 60417 No. 417-IEC-5140: Source of non-ionizing radiation : U T 80 MHz 800 MHz 22

a. / AM FM FUJIFILM SonoSite RF FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3V/m FCC FCC Rules 15 X-Porte IEC 60601-1-2 IEC 60601-2-37 X-Porte 1 23

24

2 ALARA ALARA ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI ALARA EN 60601-2-37 42 30 2 25

ALARA (ISPTA) 720 mw/cm 2 (MI) (TI) 1.0 ISPTA 50 mw/cm2 TI 1.0 MI 0.23 MI TI ALARA MI TI BS EN 60601-2-37:2001 Annex HH HH MI TI MI TI 27 Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). 26

MI TI MI TI MI TI MI TI MI TI 1 MI C60xp HFL50xp ICTxp L25xp L38xp P21xp ALARA MI MI 2 TI (TIS, TIC, TIB) CPD PRF PW C60xp ( HFL50xp ( ICTxp ( L25xp ( L38xp ( P21xp (PRF) TI TI 2 27

AIUM MI TI 29 3 TI MI 1.0 3 TI MI 1.0 2D/ M CPD/ PW Doppler CW Doppler 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 1.0 MI 0.1 TI TI 0.1 TI TI ALARA TI FUJIFILM SonoSite AIUM TI 29 MI TI MI 95% MI 95% MI +18% -25% +0.2 28

TI 95% TI 95% TI +21% -40% +0.2 +1dB 3dB MI TI 0.0 0.05 55 MI TI ALARA Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 1997. Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004. Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD3-2004. Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN 60601-2-37 reprinted at P05699. 2 29

4 5 (23 C ± 3 C) EN 60601-2-37 4 ( 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) 9,8 ( 10 C) 5 ( C ) ICTxp 8.9 4.7 (<6 C) (bioeffects) 1987 10 (AIUM) Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988:Vol. 7, No. 9 Supplement) Stowe 1993 1 28 Bioeffects and Safety of Diagnostic Ultrasound Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA UD2-2004) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (NEMA UDe3-2004) 30

= [e -(0.23alf ) ] = = e = 2.7183 a = (db/cm MHz) = 0.53 = 0.66 = 0.79 ALARA = 0.43 = 0.55 l = cm f = / / MHz 2 31

0.3 = [e -(0.069lf ) ] 0.3dB/cmMHz 3cm 1dB/cmMHz 1990 MI 0.1 1.0 MI 2.0 M MI 1988 1990 1 C 4 C 1.5 C 7 C I SPTA 500 mw/cm 2 Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993) 4.3.2.1-4.3.2.6 6 27 TI MI 1 75 32

6 C60xp2D M.I. TIC A aprt 1 A aprt >1 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) 0.517 PRF (Hz) 6027 p r @PII max (MPa) 3.26 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 322 1 2 3 4 MB/THI 9.9cm / TIS TIB ALARA (a) <1 (b) # / 2 33

7 C60xpM Mode M TIS TIB M.I. TIC A aprt 1 A aprt >1 1.5 - (a) - 1.7 (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) 2.73 - # - 2.16 # A aprt X (cm) - # - 1.87 # Y (cm) - # - 1.30 # PD (μsec) 0.534 PRF (Hz) 800 p r @PII max (MPa) 3.70 d eq @Pll max (cm) 0.33 FL x (cm) - # - # FL y (cm) - # - # I PA.3 @MI max (W/cm 2 ) 392 1 2 3 7.7 cm 11 cm 4 THI (a) <1 (b) # / 34

8 C60xpColor/CPD Mode /CPD M.I. TIC A aprt 1 A aprt >1 1.2 1.0 - - - (b) p r.3 (MPa) 1.99 W 0 (mw) 81.3 - - # 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) 2.63 2.63 - - - # A aprt X (cm) 0.81 - - - # Y (cm) 1.3 - - - # PD (μsec) 1.415 PRF (Hz) 2645 p r @PII max (MPa) 2.96 d eq @Pll max (cm) - FL x (cm) 2.71 - - # FL y (cm) 6.5 - - # I PA.3 @MI max (W/cm 2 ) 346 1 2 3 2D /THI/ / / 11 cm 4 /PRF / 3049Hz 5 / / / / 6.0 cm / 414Hz / TIS TIB ALARA (a) <1 (b) # / 2 35

9 C60xpPW Doppler M.I. TIC A aprt 1 A aprt >1 1.55 - - 1.1 3.2 (b) p r.3 (MPa) 2.44 W 0 (mw) - - 66.9 # 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) 2.64 - - 2.67 2.67 # A aprt X (cm) - - 3.98 0.31 # Y (cm) - - 1.30 1.30 # PD (μsec) 1.233 PRF (Hz) 1302 p r @PII max (MPa) 2.89 d eq @Pll max (cm) 0.45 FL x (cm) - - 15.90 # FL y (cm) - - 6.50 # I PA.3 @MI max (W/cm 2 ) 239 1 2 1 mm 12 mm 12 mm 3 2 10 0 4 PRF 1302 Hz 1302 Hz 2604 Hz TIS TIB (a) <1 (b) # / 36

10 ICTxpM Mode M M.I. TIC A aprt 1 A aprt >1 1.1 - (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) 4.64 - # - # # A aprt X (cm) - # - # # Y (cm) - # - # # PD (μsec) 0.322 PRF (Hz) 1600 p r @PII max (MPa) 3.07 d eq @Pll max (cm) # FL x (cm) - # - # FL y (cm) - # - # I PA.3 @MI max (W/cm 2 ) 347 1 2 3 4 THI 4.1 cm TIS TIB ALARA a) <1 (b) # / 2 37

11 ICTxpPW Doppler M.I. TIC A aprt 1 A aprt >1 1.0 - (a) - 1.4 (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) 4.38 - # - 4.36 # A aprt X (cm) - # - 0.72 # Y (cm) - # - 0.50 # PD (μsec) 1.144 PRF (Hz) 1302 p r @PII max (MPa) 2.49 d eq @Pll max (cm) 0.19 FL x (cm) - # - # FL y (cm) - # - # I PA.3 @MI max (W/cm 2 ) 263 1 2 1 mm 12 mm 3 2 3 4 PRF 1302 Hz 1562 Hz TIS TIB (a) <1 (b) # / 38

12 L25xpM Mode M M.I. TIC A aprt 1 A aprt >1 1.0 - (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) 6.85 - # - # # A aprt X (cm) - # - # # Y (cm) - # - # # PD (μsec) 0.207 PRF (Hz) 800 p r @PII max (MPa) 3.30 d eq @Pll max (cm) # FL x (cm) - # - # FL y (cm) - # - # I PA.3 @MI max (W/cm 2 ) 267 1 2 3 3.5 cm TIS TIB ALARA (a) <1 (b) # / 2 39

13 L25xpColor/CPD /CPD M.I. TIC A aprt 1 A aprt >1 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) 0.630 PRF (Hz) 1599 p r @PII max (MPa) 3.13 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 362 1 2 CPD 3 2D / / 2.4 cm 4 /PRF / 312 Hz 5 / / TIS TIB (a) <1 (b) # / 40

14 L25xpPW Doppler M.I. TIC A aprt 1 A aprt >1 (a) - - - 1.1 (b) p r.3 (MPa) # W 0 (mw) - - 14.8 # 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) # - - - 6.00 # A aprt X (cm) - - - 0.60 # Y (cm) - - - 0.30 # PD (μsec) # PRF (Hz) # p r @PII max (MPa) # d eq @Pll max (cm) 0.16 FL x (cm) - - - # FL y (cm) - - - # I PA.3 @MI max (W/cm 2 ) # 1 2 7 mm 3 6 4 PRF 1562 TIS TIB ALARA (a) <1 (b) # / 2 41

15 L38xp2D M.I. TIC A aprt 1 A aprt >1 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) 0.426 PRF (Hz) 790 p r @PII max (MPa) 4.02 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 622 1 2 3 4 MB 5 3.5 cm / TIS TIB a) <1 (b) # / 42

16 L38xpM Mode M M.I. TIC A aprt 1 A aprt >1 1.5-1.5-2.0 (b) p r.3 (MPa) 3.37 W 0 (mw) - 66.8 66.8 # 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) 5.22-4.40-4.40 # A aprt X (cm) - 2.40-2.40 # Y (cm) - 0.40-0.40 # PD (μsec) 0.277 PRF (Hz) 800 p r @PII max (MPa) 4.18 d eq @Pll max (cm) 0.62 FL x (cm) - 7.02 - # FL y (cm) - 1.50 - # I PA.3 @MI max (W/cm 2 ) 538 1 2 3 4.0 cm 9.0 cm 9.0 cm TIS TIB ALARA a) <1 (b) # / 2 43

17 L38xpColor/CPD /CPD M.I. TIC A aprt 1 A aprt >1 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) 0.578 PRF (Hz) 5064 p r @PII max (MPa) 3.78 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 678 1 2 3 2D / / 3.5 cm 4 /PRF / 6250 Hz 5 / / - TIS TIB a) <1 (b) # / 44

18 L38xpPW Doppler M.I. TIC A aprt 1 A aprt >1 1.0-2.0-2.9 (b) p r.3 (MPa) 2.21 W 0 (mw) - 80.5 80.5 # 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) 5.28-5.33-5.33 # A aprt X (cm) - 1.80-1.80 # Y (cm) - 0.40-0.40 # PD (μsec) 1.201 PRF (Hz) 1562 p r @PII max (MPa) 2.33 d eq @Pll max (cm) 0.40 FL x (cm) - 7.02 - # FL y (cm) - 1.5 - # I PA.3 @MI max (W/cm 2 ) 210 1 2 1 mm 3 mm 3 mm 3 0 11 11 4 PRF 1562 Hz 1562 Hz 1562 Hz TIS TIB ALARA a) <1 (b) # / 2 45

19 HFL50xp2D M.I. TIC A aprt 1 A aprt >1 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) 0.493 PRF (Hz) 1084 p r @PII max (MPa) 3.31 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 427 1 2 3 4 MB 5 4.8 cm / TIS TIB a) <1 (b) # / 46

20 HFL50xpM Mode M M.I. TIC A aprt 1 A aprt >1 1.2 - (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) 7.82 - # - # # A aprt X (cm) - # - # # Y (cm) - # - # # PD (μsec) 0.230 PRF (Hz) 800 p r @PII max (MPa) 4.51 d eq @Pll max (cm) # FL x (cm) - # - # FL y (cm) - # - # I PA.3 @MI max (W/cm 2 ) 401 1 2 3 1.9 cm TIS TIB ALARA a) <1 (b) # / 2 47

21 HFL50xpColor/CPD /CPD M.I. TIC A aprt 1 A aprt >1 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) 0.629 PRF (Hz) 6649 p r @PII max (MPa) 3.35 d eq @Pll max (cm) - FL x (cm) # - - # FL y (cm) # - - # I PA.3 @MI max (W/cm 2 ) 398 1 2 3 2D / 4 /PRF /4.0 cm /7812 Hz 5 / / a) <1 (b) # / TIS TIB 48

22 HFL50xpPW Doppler M.I. TIC A aprt 1 A aprt >1 (a) - 1.0 (a) 1.5 (b) p r.3 (MPa) # W 0 (mw) - 33.7 23.0 # 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) # - 6.00 # 5.99 # A aprt X (cm) - 1.20 # 0.72 # Y (cm) - 0.40 # 0.40 # PD (μsec) # PRF (Hz) # p r @PII max (MPa) # d eq @Pll max (cm) 0.18 FL x (cm) - 4.68 # # FL y (cm) - 2.50 # # I PA.3 @MI max (W/cm 2 ) # 1 2 6 mm 1 mm 3 11 7 4 PRF 1562 Hz 1953 Hz TIS TIB ALARA a) <1 (b) # / 2 49

23 P21xp2D M.I. TIC A aprt 1 A aprt >1 1.5 (a) - - - 2.0 p r.3 (MPa) 2.02 W 0 (mw) # - - 146.2 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 # - - - 2.09 A aprt X (cm) # - - - 2.10 Y (cm) # - - - 1.30 PD (μsec) 1.134 PRF (Hz) 2933 p r @PII max (MPa) 2.63 d eq @Pll max (cm) - FL x (cm) # - - 18.94 FL y (cm) # - - 9.00 I PA.3 @MI max (W/cm 2 ) 240 1 2 3 9.0 cm 35 cm 4 MB/THI / / 5 TIS TIB a) <1 (b) # / 50

24 P21xpM Mode M M.I. TIC A aprt 1 A aprt >1 1.5 - (a) - 1.9 1.4 p r.3 (MPa) 2.02 W 0 (mw) - # 61.1 107.0 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) 1.85 - # - 1.99 2.14 A aprt X (cm) - # - 2.10 2.10 Y (cm) # - - 1.30 1.30 PD (μsec) 1.134 PRF (Hz) 800 p r @PII max (MPa) 2.63 d eq @Pll max (cm) 0.35 FL x (cm) - # - 22.01 FL y (cm) - # - 9.00 I PA.3 @MI max (W/cm 2 ) 240 1 2 3 9.0 cm 11 cm 35 cm 4 THI TIS TIB ALARA a) <1 (b) # / 2 51

25 P21xpColor/CPD /CPD M.I. TIC A aprt 1 A aprt >1 1.5 2.4 - - 2.8 p r.3 (MPa) 2.02 W 0 (mw) 141.3 - - 150.9 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 2.03 - - - 2.03 A aprt X (cm) 0.33 - - - 0.33 Y (cm) 1.30 - - - 1.30 PD (μsec) 1.134 PRF (Hz) 800 p r @PII max (MPa) 2.63 d eq @Pll max (cm) - FL x (cm) 1.30 - - 1.30 FL y (cm) 9.0 - - 9.0 I PA.3 @MI max (W/cm 2 ) 240 1 2 3 2D /THI/ / / 9.0 cm 4 /PRF / 880 Hz 5 / / - / / 5.0 cm / 2500 Hz / a) <1 (b) # / TIS TIB / / 5.0 cm / 2500 Hz / 52

26 P21xpPW Doppler M.I. TIC A aprt 1 A aprt >1 1.5 - - 1.3 3.7 2.8 p r.3 (MPa) 2.15 W 0 (mw) - - 204.3 82.3 W.3 (z 1 ),I TA.3 (z 1 )] (mw) 126.9 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) 2.07 - - 2.09 2.09 2.08 A aprt X (cm) - - 2.10 2.10 0.33 Y (cm) - - 1.30 1.30 1.30 PD (μsec) 1.195 PRF (Hz) 1562 p r @PII max (MPa) 2.37 d eq @Pll max (cm) 0.49 FL x (cm) - - 14.01 1.30 FL y (cm) - - 9.0 9.0 I PA.3 @MI max (W/cm 2 ) 184 1 2 0 mm 14 mm 14 mm 7 mm 3 1 8 8 0 4 PRF 1562 Hz 1562 Hz 1562 Hz 1953 Hz 5 TDI - - - TIS TIB ALARA a) <1 (b) # / 2 53

27 P21xpCW Doppler M.I. TIS A aprt 1 A aprt >1 TIB (a) - 1.1-4.0 2.6 p r.3 (MPa) # W 0 (mw) - 113.2 110.9 113.2 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) # - 2.0-2.00 2.00 A aprt X (cm) - 0.72-0.85 0.72 Y (cm) - 1.30-1.30 1.30 PD (μsec) # PRF (Hz) # p r @PII max (MPa) # d eq @Pll max (cm) 0.47 FL x (cm) - 1.30-1.30 I PA.3 @MI max (W/cm 2 ) # FL y (cm) - 9.0-9.0 1 2 0 1 0 TIC a) <1 (b) # / 54

Output Display Standard 6.4 28 % 95% Pr 1.9% +11.2% Pr.3 1.9% +12.2% Wo 3.4% +10% fc 0.1% +4.7% PII 3.2% +12.5-16.8% PII.3 3.2% +13.47-17.5% ALARA 2 55

56

3 18 67.1 cm 53.8 cm 162.6 cm 107.2 cm 47.8 cm 36 cm 43 cm 40.8 cm 25.8 cm 30.7 cm 2D 256 Color Power Doppler (CPD) 256 Color Doppler (Color) 256 M Mode M Pulsed wave (PW) Doppler Continuous wave (CW) Doppler 3 57

Tissue Doppler Imaging (TDI) Tissue Harmonic Imaging (THI) 10 40 C, 15 95% 800 1060hPa 0.79 1.05-35 60 C, 15 95% 500 1060hPa 0.5 1.05 100 240V ~ 50/60 Hz 6.0A 58

1 IEC 60601-1:1988 IEC 60601-2-37:2001 + A1:2004 IEC 60601-1-1:2000 IEC 60601-1-4:2000 Medical Electrical Equipment Part 1. General Requirements for Safety - 1 2 1 2 IEC 60601-1:1988 1 General Requirements for Safety 2 1 2 IECEE CB Medical Electrical Equipment Part 1-1. General Requirements for Safety-Section 1-1 - 1-1 1-1 Collateral Standard Safety Requirements for Medical Electrical Systems Medical Electrical Equipment Part 1-4. General Requirements for Safety-Section 1-4 - 1-4 1-4 Collateral Standard Programmable Electrical Medical Systems EC 60601-1:2005/A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-1 IEC 60601-2-37:2007 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 - 2-37 IEC 60601-1:2005/A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 3 1 IECEE CB Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment 3 59

EMC 2 EMC IEC 60601-1-2:2007 General Requirements for Basic Safety and Essential Performance-Collateral Standard - CISPR 11:2004 Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement (ISM) - Group 1, Class A 1 A DICOM NEMA PS 3.15:2000 (DICOM) - 15 X-Porte DICOM DICOM www.sonosite.com HIPAA HIPAA The Health Insurance and Portability and Accountability Act, Pub.L.No. 104-191 (1996). 45 CFR 160, General Administrative Requirements 45 CFR 164, Security and Privacy 2D 10 10 10 60

3 2D 2D a b (cm) < ±2% + 1% 0 26 cm < ±2% + 1% 0 35 cm < ±2% + 1% 0 44 cm c d < ±4% + ( 2% / ) * 100 + 0.5% < ±3% + ( 1.4% / ) * 100 + 0.5% 0.01 720 cm 2 0.01 96 cm a. b. 0.7 db/cm MHz RMI 413a c. % = ((1 + ) * (1 + ) 1) * 100 + 0.5% d. % =( 2 (2 ) * 100) + 0.5% 4 M M < +/- 2% + 1% a b 0 26 cm < +/- 2% + 1% c d 0.01 10 < +/- 2% + ( c * /100)% d 5 923 bpm a. b. 0.7 db/cm MHz RMI 413a c. d. FUJIFILM SonoSite 3 61

5 PW a < +/- 2% + 1% b 0.01 cm/ sec- 550 cm/sec < +/- 2% + 0.01 khz 20.8 khz 1% b < +/-2% + 0.01 10 1% c a. FUJIFILM SonoSite b. c. Acquisition Error Algorithmic Error 62

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

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

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

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

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

U USB U U USB USB USB U Incompatible power supply.. 18 internal storage device is full. (DICOM) DICOM Config DICOM Archiver Exclude Video Clips FUJIFILM SonoSite 68

1 2 System Information a b MORE System Settings System Information System Licensing Scanhead Licensing 3 FUJIFILM SonoSite FUJIFILM SonoSite 5 System Information 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

X-Porte X-Porte FUJIFILM SonoSite ON FUJIFILM SonoSite FUJIFILM SonoSite 5 X-Porte FUJIFILM SonoSite Digital Imaging and Communications in Medicine (DICOM) (LAN) FUJIFILM SonoSite DICOM X-Porte DICOM DICOM FUJIFILM SonoSite U X-Porte USB FUJIFILM SonoSite X-Porte 70

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

1 1 2 3 1 2 72

AIUM 1997 Recommended Ultrasound Terminology, Second Edition AIUM (ALARA) (in situ) LCD (MI) MI/TI SonoMB (TI) TIB C (60) C60xp 1538.5 / L (38) L38xp MI MI 2 (MI) (TI) 2D 2D / 1 C TI 2 73

TIC TIS (TDI) 74

A aprt d eq (z) d eq @PII max A aprt fc FL I pa.3 @MImax I SPTA.3 I SPTA.3 (z 1 ) MI PD P r.3 p r @PII max PRF TI TI TIB TIC TIS W.3 (z 1 ) cm 2 z ( 4 ( π) )(( Wo) ( ITA( z) )), I TA (z) z cm cm (x) (y) cm MHz (x) (y) cm MI W/cm 2 mw/cm 2 z 1 / MI MI MI Hz TIB TIS TIS z 1 mw 75

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

AIUM 73 ALARA 25, 73 DICOM 60 DVD 67 EMC 60 HIPAA 60 LCD 29 SonoMB 73 71 71 73 57 57 58 58 11 A 14 9 13 7 13 B 71 70 63 DICOM 60 EMC 60 HIPAA 60 59 30 C 62 60 62 74 72 71 D 67 14 9 58 9 12 26 12 F, 63 18 G 73 67 57 H 58 30 72 74 73 77

67 73 73 69 69 71 J 59 (MI) 29, 73 5 17 26 26, 55, 5 16 K 23 67 5 26 26 26 68 L 13 74 P 70 Q 58 73 R (TI) 29, 73 7 68 74 S 13 32 73 26 55 31 31 (in situ) 31 C60xp 2D 33 Color/CPD /CPD 35 M 34 PW Doppler 35, 36 HFL50xp 2D 46 Color/CPD /CPD 48 M Mode M 47 PW Doppler 49 ICTxp M Mode M 37 PW Doppler 38 L25xp Color/CPD /CPD 40 M Mode M 39 PW Doppler 40, 41 L38xp 2D 42 Color/CPD /CPD 44 M 43 PW Doppler 45 P21xp 2D 50 Color/CPD /CPD 52 CW Doppler 54 M Mode M 51 PW Doppler 53 32, 75 31 58 78

29 73 T CPD 67 67 67 26 Z 26 26 20, 5 71 74 32 74 W 18 70 71 26 58 15 62 62 62 X 70 70 71 73 30 73 70 68 Y 73 12, 5 14 70 73 58 79

80

P14670-01 *P14670-01*