FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 +1-888-482-9449 +1-425-951-1200 +1-425-951-1201 Emergo Europe Molenstraat 15 2513 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. 2013 FUJIFILM SonoSite, Inc. P14672-01 2013 6 c
... 5... 5 1... 7... 8... 8... 8... 9... 9 X-Porte...11...12...12...13...13...14...15...16...16...19 2 ALARA...23 ALARA...23...24...24 (MI) (TI)...24...26...27...27...27...28...28...29...30...30...53 iii
3... 55... 56... 56... 56... 56... 56... 56... 57 EMC... 58 DICOM... 59 HIPAA... 59... 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 +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
MSD 8
MSD Class I I I I I BF CF IPX-7 IPX-8 AP/APG ECG ECG EN60601-1 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
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 60601-1-1 IEC 60601-1-2 IEC 60950 (ITE) IEC 60601-1 10
FUJIFILM SonoSite X-Porte Power X-Porte Power Power X-Porte 1 11
X-Porte / 1948 FUJIFILM SonoSite ALARA MI TI FUJIFILM SonoSite 0.3 db/cm/mhz FUJIFILM SonoSite 12
P21xp P21xp IEC 60601-1-2:2007 EMC FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 16 1 13
EMC (RF) (RF) (EMI) EMI EMI EMI EMI EMI EMI EMI IEC 60601-1-2 EMC X-Porte IEEE 802.11 2.412 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 2.484 GHz 16 dbm + 1.5 dbm @ 11 Mbps (DSSS) IEEE 802.11g 2.412 2.484 GHz 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) 14
(ESD) ESD ESD ESD ESD ESD (TTC) ( ) ESD ESD ESD ESD IEC 60601-1-2 5.2.1.2 d 1 15
RF X-Porte X-Porte (RF) X-Porte RF X-Porte 1 150 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) (W) 80 MHz 800 MHz FUJIFILM SonoSite X-Porte IEC 60601-1-2:2007 FUJIFILM SonoSite X-Porte X-Porte 16
2 X-Porte L25xp L38xp P21xp 2.2 1.7 1.75 ICTxp HFL50xp 1.7 1.7 C60xp 1.7 1.5 3 - - - DVR USB (64 GB) - ECG 0.6 / 0.6 ECG Kensington 1.8 1.8 1.8 3 3 1.8 Power Park - - SPMU - - 1 17
2 X-Porte 3.1 - - - USB (16 GB) - USB (32 GB) - USB (64 GB) - - 1.8 1.8 1.2 1 1.8 0.57 18
3 4 EMC 3 - ClSPR 11 1 X-Porte RF ClSPR 11 A X-Porte IEC 61000-3-2 A / IEC 61000-3-3 1 19
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 U T >95% 0.5 40% U T U T 60% 5 70% U T U T 30% <5% U T U T >95% 0.5 40% 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 61000-4-8 3 / 3 / FUJIFILM SonoSite 20
4 - IEC 60601 IEC 61000-4-6 3Vrms 150 khz 80 MHz 3Vrms FUJIFILM SonoSite RF d = 1.2 P IEC 61000-4-3 3 / 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 60417 No. 417-IEC-5140 Source of non-ionizing radiation U T 80 MHz 800 MHz 1 21
a. / FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite b. 150 khz 80 MHz 3 / 15 X-Porte IEC 60601-1-2 IEC 60601-2-37 X-Porte 22
2 ALARA ALARA ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI 2D ALARA EN 60601-2-37 42 28 3 2 23
ALARA (ISPTA) 720 (MI) (TI) 1.0 ISPTA 50 TI 1.0 MI 0.23 MI TI ALARA MI TI BS EN 60601-2-37:2001 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
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
MI TI AIUM 27 3 TI MI 1.0 3 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 1.0 0.1 MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI 27 26
MI 95% 95% MI MI +18% -25% +0.2 TI 95% 95% TI TI +21% -40% +0.2 +1dB 3dB MI TI 0.0 0.05 53 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 NEMA Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993. 2 27
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD3-2004 NEMA 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. 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) 9.5 ( 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 (Stowe Report)1993 1 28 (Bioeffects and Safety of Diagnostic Ultrasound) 28
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 = 2.7183 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
0.3 db/cm MHz 3 1dB/cmMHz 1990 MI 0.1 1.0 MI 2.0 2D MMode M MI 1988 1990 1 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 30
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) 0.517 (PRF) (Hz) 6027 p r @PII max (MPa) 3.26 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 322 1 2 3 4 / (MB/THI) FL y (cm) # - - # 9.9 cm / ALARA (a) <1 (b) # / 2 31
7 C60xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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) - # - # I PA.3 @MI max (W/cm 2 ) 392 FL y (cm) - # - # 1 2 3 7.7 cm 11 cm 4 (THI) (a) <1 (b) # / 32
8 C60xp (Color)/ (CPD) (MI) (TIS) (TIB) (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 (Color) (Color) 3 2D / (THI)/ 4 / (PRF) / / 11 cm /3049Hz / / 6.0 cm /414Hz 5 / / / ALARA (a) <1 (b) # / 2 33
9 C60xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 # I PA.3 @MI max (W/cm 2 ) 239 FL y (cm) - - 6.50 # 1 2 1 mm 12 mm 12 mm 3 2 10 0 4 (PRF) 1302 Hz 1302 Hz 2604 Hz (a) <1 (b) # / 34
10 ICTxpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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) - # - # I PA.3 @MI max (W/cm 2 ) 347 1 2 3 4 (THI) FL y (cm) - # - # 4.1 cm ALARA a) <1 (b) # / 2 35
11 ICTxp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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) - # - # I PA.3 @MI max (W/cm 2 ) 263 FL y (cm) - # - # 1 2 1 mm 12 mm 3 2 3 4 (PRF) 1302 Hz 1562 Hz (a) <1 (b) # / 36
12 L25xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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) - # - # I PA.3 @MI max (W/cm 2 ) 267 1 2 3 FL y (cm) - # - # 3.5 cm ALARA (a) <1 (b) # / 2 37
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) 0.630 (PRF) (Hz) 1599 p r @PII max (MPa) 3.13 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 362 1 2 FL y (cm) # - - # (CPD) 3 2D / / 2.4 cm 4 / /312 Hz (PRF) 5 / / (a) <1 (b) # / 38
14 L25xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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) - - - # I PA.3 @MI max (W/cm 2 ) # 1 2 3 FL y (cm) - - - # 7 mm 4 (PRF) 1562 6 ALARA (a) <1 (b) # / 2 39
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) 0.426 (PRF) (Hz) 790 p r @PII max (MPa) 4.02 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 622 1 2 3 4 MB 5 FL y (cm) # - - # 3.5 cm / a) <1 (b) # / 40
16 L38xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 - # I PA.3 @MI max (W/cm 2 ) 538 FL y (cm) - 1.50 - # 1 2 3 4.0 cm 9.0 cm 9.0 cm ALARA a) <1 (b) # / 2 41
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) 0.578 (PRF) (Hz) 5064 p r @PII max (MPa) 3.78 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 678 1 2 FL y (cm) # - - # (Color) 3 2D / / 3.5 cm 4 / (PRF) / 6250 Hz 5 / / - 42
18 L38xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 - # I PA.3 @MI max (W/cm 2 ) 210 FL y (cm) - 1.5 - # 1 2 1 mm 3 mm 3 mm 3 0 11 11 4 (PRF) 1562 Hz 1562 Hz 1562 Hz ALARA a) <1 (b) # / 2 43
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) 0.493 (PRF) (Hz) 1084 p r @PII max (MPa) 3.31 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 427 1 2 3 4 MB 5 FL y (cm) # - - # 4.8 cm / a) <1 (b) # / 44
20 HFL50xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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) - # - # I PA.3 @MI max (W/cm 2 ) 401 1 2 3 FL y (cm) - # - # 1.9 cm ALARA a) <1 (b) # / 2 45
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) 0.629 (PRF) (Hz) 6649 p r @PII max (MPa) 3.35 d eq @Pll max (cm) - FL x (cm) # - - # I PA.3 @MI max (W/cm 2 ) 398 1 2 3 2D / FL y (cm) # - - # CVD /4.0 cm 4 / /7812 Hz (PRF) 5 / / 46
22 HFL50xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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 # # I PA.3 @MI max (W/cm 2 ) # FL y (cm) - 2.50 # # 1 2 6 mm 1 mm 3 11 7 4 (PRF) 1562 Hz 1953 Hz ALARA a) <1 (b) # / 2 47
23 P21xp2D (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 I PA.3 @MI max (W/cm 2 ) 240 FL y (cm) # - - 9.00 1 2 3 9.0 cm 35 cm 4 / (MB/THI) / 5 / a) <1 (b) # / 48
24 P21xpM (M Mode) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 I PA.3 @MI max (W/cm 2 ) 240 FL y (cm) - # - 9.00 1 2 3 9.0 cm 11 cm 35 cm 4 (THI) ALARA a) <1 (b) # / 2 49
25 P21xp (Color)/ (CPD) (MI) (TIS) A aprt 1 A aprt >1 (TIB) a) <1 (b) # / (TIC) 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)/ 4 / (PRF) (Color) / / 9.0 cm 5 / / - (Color) / / 5.0 cm /880 Hz / 2500 Hz / (Color) / / 5.0 cm / 2500 Hz / 50
26 P21xp (PW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) 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 I PA.3 @MI max (W/cm 2 ) 184 FL y (cm) - - 9.0 9.0 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) - - - ALARA a) <1 (b) # / 2 51
27 P21xp (CW Doppler) (MI) (TIS) A aprt 1 A aprt >1 (TIB) (TIC) (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 a) <1 (b) # / 52
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 53
54
3 16 67.1 53.8 162.6 107.2 47.8 36 43 40.8 25.8 30.7 3 55
2D 256 (CPD) 256 (Color) 256 M (M Mode) (PW) (CW) (TDI) (THI) 10 40 C 15 95% 800 1060 hpa 0.79 1.05-35 60 C 15 95% 500 1060 hpa 0.5 1.05 100-240V ~ 50/60 Hz 6.0A 56
1 IEC 60601-1:1988 IEC 60601-2-37:2001 + Amendment A1:2004 Medical Electrical Equipment Part 1. General Requirements for Safety 1 2 1 2 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment; as applied to IEC 60601-1:1988, 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 60601-1:1988 1 2 1 2 IECEE CB Scheme IEC 60601-1-1:2000 IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-1. General Requirements for Safety Section 1-1. Collateral Standard.Safety Requirements for Medical Electrical Systems. 1-1 1-1 Medical Electrical Equipment Part 1-4. General Requirements for Safety Section 1-4. Collateral Standard. Programmable Electrical Medical Systems. 1-4 1-4 EC 60601-1:2005/A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - 1 3 57
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; as applied to IEC 60601-1:2005/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. - 2-37 IEC 60601-1:2005/A1:2012-1 3 1 IECEE CB Scheme Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment. EMC 2 EMC IEC 60601-1-2:2007 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
DICOM NEMA PS 3.15:2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles NEMA PS3.15 2000 (DICOM) - 15 DICOM X-Porte DICOM www.sonosite.com HIPAA HIPAA The Health Insurance and Portability and Accountability Act, Pub.L.No. 104-191 (1996). 1996 104-191 45 CFR 160, General Administrative Requirements 45 CFR 164, Security and Privacy 3 59
2D 10 10 3 2D 2D a b < ±2% 1% 0 26 < ±2% 1% 0 35 < ±2% 1% 0 44 c d < ±4% + ( 2% ) * 100 + 0.5% < ±3% + ( 1.4%/ ) * 100 + 0.5% 0.01 720 0.01 96 a. b. 0.7 db/cm MHz RMI 413a c. % = ((1 + ) * (1 + ) 1) * 100 + 0.5% d. % = ( 2 (2 ) * 100) + 0.5% 60
4 M M < +/- 2% 1% a b 0 26 < +/- 2% 1% c d 0.01 10 < +/- 2% + ( c * /100) % d 5-923 a. b. 0.7 db/cm MHz RMI 413a c. d. FUJIFILM SonoSite 5 a < +/- 2% 1% b 0.01-550 < +/- 2% 0.01-20.8 1% b < +/- 2% 0.01 10 1% c a. FUJIFILM SonoSite b. c. 3 61
62
4 c (AC) 1 93/42/EEC VII 1 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 Mark ) WARNING: Connect Only Accessories and Peripherals Recommended by FUJIFILM SonoSite FUJIFILM SonoSite 66
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
USB USB USB USB USB USB USB USB USB USB Incompatible power supply...... 16 internal storage device is full (DICOM) DICOM Archiver Exclude Video Clips FUJIFILM SonoSite 68
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
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
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
1 1 2 3 1 2 72
AIUM 1997 Recommended Ultrasound Terminology, Second Edition AIUM (ALARA) C (60) C60xp 1538.5 / LCD (MI) MI/TI SonoMB (TI) TIB L (38) L38xp MI MI 2 (MI) (TI) 2D 2D / 1 C TI 2 73
TIC TIS (TDI) Color Doppler 74
A aprt d eq (z) z ( 4 ( π) )(( Wo) ( ITA( z) )) I TA (z) 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 ) (x) (y) (x) (y) MI / / z 1 / MI MI MI TIB TIS TIS z 1 75
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
AIUM 73 ALARA 23, 73 DICOM 59 DVD 67 EMC 58 HIPAA 59 LCD 27 SonoMB 73 7, 5 71 24 70 56 56 67 13 73 71 72 71 71 16 24 12 7 12 9 13 24 5 68 71 55 73 29 29 29, Color 67, CPD 67 67 24 71 56 5 22 11 68 62 24 24 24 24 77
74 DICOM 59 EMC 58 HIPAA 59 57 63 (MI) 27, 73 57 56, 5 70 73 73 24 60 62 27 56 56 14 (TI) 27, 73 56 67 24 73 73, 63, 53 30 74 74 71 70 53 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) 52 28 30, 75 L38xp 2D 40 12 11 73 28 12 30 19 55, 70 62 62 62, 5 70 71 70 73 74 68 78
27 72 67 74 69 73 73 73 28 69 56 16 67 11 24 16 9 56 9 11 13 15, 70 74 73 79
80
P14672-01 *P14672-01*