FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 +1-888-482-9449 +1-425-951-1200 +1-425-951-1201 FUJIFILM SonoSite B.V. Joop Geesinkweg 140 1114 AB Amsterdam, FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE, NSW, 2100 iviz SonoSite SonoSite FUJIFILM SonoSite, Inc. FUJIFILM FUJIFILM Corporation Value from Innovation FUJIFILM Holdings America Corporation DICOM (National Electrical Manufacturers Association) P22806-05 2018 4 2018 FUJIFILM SonoSite, Inc.
1. SonoSite iviz... 1-1... 1-1... 1-2 2. SonoSite iviz... 2-1... 2-2... 2-2... 2-3... 2-3... 2-4... 2-6... 2-6... 2-8... 2-9... 2-9...2-10...2-10...2-11 SonoSite iviz...2-11...2-11...2-12...2-14 SonoSite iviz...2-14 SonoSite iviz...2-14 SonoSite iviz...2-15...2-15 iii
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5.... 5-1... 5-2... 5-2... 5-3... 5-4... 5-5... 5-5... 5-6 CVD CPD... 5-8... 5-9... 5-9...5-10...5-11...5-11 M...5-12 M...5-12 M Mode...5-12...5-13...5-14...5-14...5-16...5-17...5-17...5-17...5-19...5-19...5-20 efast...5-20 FATE...5-21 RUSH...5-21 v
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FUJIFILM SonoSite +1-877-657-8118 +1-425-951-1330 +1-425-951-6700 ffss-service@fujifilm.com www.sonosite.com +31 20 751 2020 +44 14 6234 1151 +33 1 8288 0702 +49 69 8088 4030 +39 02 9475 3655 +34 91 123 8451 +65 6380-5581 1-2
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SonoSite iviz 2-3 2-3 SonoSite iviz Patient Scan Learn Patient- SonoSite iviz Scan - Learn - SonoSite iviz SonoSite iviz 2-4 2-6
FREEZE SAVE C COLOR 2D Orient Dynamic Range RES PEN Patient: John Smith ID: 1234567890 P21v: Abdomen (Abd) MI: 0.0 TI: 0.0 THI DR: 0 Pen MHz 0.00 Opt 89% 13% End Study 09:15 01/01/2015 2-4 1 8 - - 2 9 3 10 4 11 5 12 Android 6 Patient 13 7 2-7
- - - - - 5 2-8
Exam Type 2-9
SonoSite iviz 2-5 2-5 SonoSite iviz RF SAR RF 1 2 2-10
SonoSite iviz SonoSite iviz 1 SonoSite iviz SonoSite iviz 2 SonoSite iviz 2-11
FUJIFILM SonoSite USB (P19927) -20 C 60 C 10 C 40 C SonoSite iviz USB 11-23 SonoSite iviz SonoSite iviz USB SonoSite iviz 1 2-15 SonoSite iviz 2 2-12
3 USB SonoSite iviz SonoSite iviz 4 5 SonoSite iviz 1 2 3 SonoSite iviz SonoSite iviz 4 2-13
/ / SonoSite iviz FUJIFILM SonoSite 1 2-15 SonoSite iviz 2 SonoSite iviz 3 SonoSite iviz FUJIFILM SonoSite SonoSite iviz 2-12 SonoSite iviz SonoSite iviz 1 SonoSite iviz 2-11 2 2-14
3 SonoSite iviz SonoSite iviz SonoSite iviz 1 2 Power off OK power off 30 3-4 SonoSite iviz 2-15
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SonoSite iviz Android SonoSite iviz Google Android (OS) Android OS Android FUJIFILM SonoSite Android 3 Android Settings 1 2 Apps 3 Apps Settings FUJIFILM SonoSite Security PIN IT 1 Android Settings Wi-Fi ON Wi-Fi 2 Wi-Fi 3 Done SonoSite iviz 3-1
4 Connect 5 Wi-Fi Connected (VPN) SonoSite iviz VPN 3-1 VPN VPN VPN VPN VPN 1 Android Settings Wireless & Networks More 2 VPN 3 VPN 4 VPN VPN VPN 5 Save 6 VPN VPN VPN Save account information 7 VPN + 4-6 Bluetooth 1 Android Settings Bluetooth 2 Bluetooth Bluetooth ON Bluetooth 3 4 Bluetooth Bluetooth 5 Bluetooth 3-2 SonoSite iviz
SonoSite iviz SonoSite iviz 1 Android Settings Date & Time 2 Date & Time Automatic date & time 3 Set date Done 4 Set time Done 24 12 1 Android Settings Date & Time 2 24 Date & Time Use 24-hour format 24 3 12 Date & Time Use 24-hour format 24 < >/< >/< > SonoSite iviz 1 Android Settings Choose date format 2 1 Android Settings Sound 2 Sound Volumes 3 OK SonoSite iviz 3-3
1 Android Settings Display 2 Display Brightness 3 Auto 4 SonoSite iviz SonoSite iviz 3-4 Android SonoSite iviz 3-6 SonoSite iviz Android 1 Android Settings Display 2 Display Sleep 3 SonoSite iviz 3-4 Android Security > Screen > Android None 10 3-4 SonoSite iviz
PrintHand Android Wi-Fi 3-1 1 Android Settings Printing 2 Printing PrintHand 3 OFF 4 Use PrintHand PrintHand OK 5 Add a printer 6 Nearby Printers Nearby Wi-Fi Printers Wi-Fi SonoSite iviz 7 8 Driver Needed Select Manually Next Generic 9 10 Install 11 Print Test 12 Finish SonoSite iviz SonoSite iviz SonoSite iviz Settings / DICOM ID SonoSite iviz 3-5
SonoSite iviz SonoSite iviz Settings 1 SonoSite iviz Settings Preferences 2 Preferences Units - Generic Volume Calcs- Ellipsoid - x x x /6 Cuboid - x x Thermal Index - TIB - TIC - TIS - Auto Save Patient Form - Clip Recording - Prospective - Save Prospective - Save Clip Length - Anonymize on USB Share USB - USB AVI DICOM USB OFF USB Structured Reports USB - USB OFF 3-6 SonoSite iviz
Scan Power Management - Energy Saver- Standard- Custom - Slow frame rate - Never Freeze - Never Sleep - Never Power off - SonoSite iviz SonoSite iviz 3-7
1 SonoSite iviz Settings OB Calcs 2 OB Calculations GS - CRL - BPD - Cx Length - HC - AC - FL - HL - 1 SonoSite iviz Settings OB Calcs 2 Gestational Age Restore 10 1 SonoSite iviz Settings Labels 2 Labels Custom Labels Default Labels 1 Labels 2 3 Add 3-8 SonoSite iviz
Restore DICOM SonoSite iviz (DICOM) SonoSite iviz Tricefy DICOM Tricefy Tricefy Tricefy DICOM 1 SonoSite iviz Settings DICOM Profiles DICOM 2 New Profile 3 General a Profile Name b AE Title AE (AE) AE SonoSite iviz 3-9
4 Institution Archive IP Address IP Subnet Mask Default Gateway Wireless a AE Title AE (AE) AE b IP Address IP IP c Port d Transfer images End of Exam - Manual - e Structured Reports Yes No f Educational Yes No g Active Inactive h Ping i Verify SonoSite iviz 5 Worklist a AE Title AE (AE) AE b IP Address IP IP c Port d Worklist Today - Yesterday - +/- 7 days 7 - e Auto Query On Off f Modality Ultrasound All g Occurs Every h Active Inactive i Ping j Verify SonoSite iviz 3-10 SonoSite iviz
6 DICOM Profiles DICOM On DICOM DICOM DICOM 1 DICOM settings 2 DICOM DICOM 1 DICOM settings Edit 2 DICOM 3 Done Tricefy Collaboration Tricefy Collaboration DICOM DICOM settings DICOM (OFF) SonoSite iviz Name DOB Study Dates / 1 SonoSite iviz Settings Patient Search 2 Patient Search 3 SonoSite iviz 3-11
ID 1 SonoSite iviz Settings Patient Search 2 Patient Search ID 3 4-3 SonoSite iviz SonoSite / SonoSite iviz HDMI SonoSite iviz 3-12 SonoSite iviz
4 SonoSite iviz SonoSite iviz SonoSite iviz SonoSite iviz ID ID ID 4-4 4-1
Patient Patient Patient SonoSite iviz SonoSite iviz 1 Patient Patient 2 Worklist 3 Name - / Patient ID ID - ID ID Study Dates- Study Dates Set the date - Set the range - Study Date 1 Patient Search 2 3 4 Search 5 4-2
SonoSite iviz ID 3-12 Barcode Capture 6 ID SonoSite iviz SonoSite iviz Worklist Schedule Patient Schedule 1 Patient 2 Worklist Patient 4-3
1 Select 2 3 4 5 Next 6 PACS 7 Share 1 Select 2 3 1 4-2 New Study 2 Notes 4-4
3 Exam Type Exam Purpose Procedure Code Procedure Meaning Reading Doctor Referring Doctor Study Date User SonoSite iviz 4 Save 4-1 SonoSite iviz End Study Anonymize on USB Share USB USB 1 Patient iviz Studies iviz 2 Select 3 4-5
4 Local PACS PACS - DICOM Tricefy - Tricefy Tricefy SonoSite iviz 30 Tricefy 30 500 USB - USB 5 Next 6 PACS 7 Share Tricefy 1 Patient iviz Studies iviz 2 Select 3 4 Tricefy 5 Yes Tricefy Uplink 6 Tricefy Tricefy 7 8 Accept Invitation Tricefy4.com 9 10 Share Archive to Cloud Tricefy 1 Patient iviz Studies iviz 2 3 Tricefy 4 Tricefy Change Activation 5 Yes Tricefy 4-6
1 4-2 2 3 Measurements Edit 4 5 6 Notes 7 Save Save Report Save / Close 8 Cancel 4-7
1 2 3 Add images to Report 4 5 Add Patient Report 6 Edit 7 Done 8 Save 1 4-2 2 3 Print 4 Print 4-8
SonoSite iviz USB SonoSite iviz 5 SonoSite iviz Freeze SonoSite iviz ROI 5-1
Scan SonoSite iviz Freeze SonoSite iviz Color 2D Color Color Depth 2D Color Box Color Gain 5-2
2D Color Mode M Mode M Motion Mode Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 8th ed., W.B. Saunders Company, (Nov. 10, 2010). 2D M Mode M Mode 2D M 2D Color 2D 5-5 M M Mode 2D M Mode 5-12 M 5-3
(Oph) FDA (Oph) SonoSite iviz SonoSite iviz SonoSite iviz 5-1 GYN Lung MSK OB C60v L25v L38v P21v Lung 5-4
1 Exam Type 2 FUJIFILM SonoSite Aquasonic FUJIFILM SonoSite 1 2 3 4 5 6 patient 4 SonoSite iviz 2-6 5-5
2D SonoSite iviz 2D M Mode 2D Color Color Depth 2D Color Box Color Gain SonoSite iviz 5-6
1 Color Box 2 Resize 3 Move 4 5-7
1 2 1 Steer 2 +15 0-15 CVD CPD C SonoSite iviz (CVD) (CPD) CVD - CVD CPD - CPD CVD CPD CVD CPD 5-8
SonoSite iviz 1 Color Gain 2 Color Gain P21v 5-9
1 Scale Scale 2 CPD Invert 5-10
1 Wall Filter H Wall Filter M L 2 H - M - L - 1 Flow 2 H - M - L - 5-11
M M Mode M Mode 2D M M Mode M M M M M M M M Mode Update M Mode M M Update 5-12
1 Update 2 Speed S Speed M F 3 S - M - F - 5-13
SonoSite 1 Orient 2 // Orient L25v L38v Centerline 5-14
5-1 5-2 5-15
Res - Pen - THI - (THI) P21v 1 Opt Opt 2 THI 5-16
1 Depth 2 Depth Overall Gain - Near/Far Gain / - 5-17
1 Overall Gain 2 Overall Gain Reset 3 Reset / 1 Near/Far Gain / 2 Near/Far Gain / 3 5-18
1 Dynamic Range 2 0 Dynamic Range SonoSite iviz P21v 1 2 5-19
PLAX PSAX IVC ph efast (efast) RUQ LUQ ph 5-20
FATE (FATE) PLAX PSAX IVC RUSH (RUSH) PLAX PSAX IVC RUQ /LUQ ph 5-21
5-22
SonoSite iviz 6 SonoSite iviz 4 SAVE SAVE 1 FREEZE ID 4 6-1
2 ID 4 SAVE SAVE 1 SAVE Preferences 3-6 2 SAVE 6-2
1 Patient 2 1 4-2 2 Images and Clips SonoSite iviz 2-8 6-3
10 12 1 2 Text Labels 3 a +Arrow + b c 4 a Right Medial b 5 12 a b Done c 6-4
6 Save 1 2 1 Patient iviz Studies iviz 2 3 4 a Select b 5 Delete USB 1 Patient iviz Studies iviz 2 3 4 a Select b 5 6-5
6 Local PACS PACS - DICOM Tricefy - Tricefy Tricefy SonoSite iviz 30 Tricefy 30 500 USB - USB Printer - 3-5 7 Next 8 PACS 9 Share 6-6
8-1 7 4-5 7-1
1 2 Measurements M 1 Measurements 2 General Distance 3 4 5 Measurements 7-2
1 Measurements 2 General Ellipse 3 4 5 7-3
6 Measurements 1 Measurements 2 General Trace 3 7-4
4 5 Measurements SonoSite iviz 4-5 SonoSite iviz Measurements 7-5
3-6 1 Measurements 2 General Volume 3 4 5 7-6
3 a Length b c 4 a Measurements b Width c d 7-7
5 a Measurements b Height c d Cardiac 7-1 LV RVWd 2D M RVDd 2D M IVSd 2D M LVDd 2D M LVPWd 2D M RVWs 2D M RVDs 2D M IVSs 2D M LVDs 2D M LVPWs 2D M MVA (2D) AVA (2D) CO CI EF SV SI LVESV LVEDV IVS LVPWFT LVDFS LV M MV AV 7-8
LVd LVs 1 Exam Type Cardiac 2 2D Measurements 3 Cardiac 4 LV 5 6 Ao LA LVET M Mode 1 Exam Type Cardiac 2 M Mode Measurements 3 Cardiac 4 LA/Ao / 5 6 MV AV 1 Exam Type Cardiac 2 2D Measurements 3 Cardiac 4 Area MVA AVA 5 6 7 (HR) 1 Exam Type Cardiac 2 M Mode Measurements 3 Cardiac 4 HR HR 7-9
5 6 (L) (W) (H) 1 Exam Type GYN 2 2D Measurements 3 GYN 4 5 6 (D) 1 Exam Type GYN 2 2D Measurements 3 GYN 4 Right Ovary Left Ovary 5 6 7-10
(D) 1 Exam Type GYN 2 2D Measurements 3 GYN 4 Right Ovary Follicle Left Ovary Follicle 5 Obstetrics 8-8 SonoSite iviz 3-8 8-3 8-8 EFW EDD EFW 7-11
7-2 a YS GS Hansmann, Nyberg, Tokyo U. CRL BPD HC Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann AC Hadlock, Hansmann, Tokyo U. FL HL Chitty, Hadlock, Hansmann, Osaka, Tokyo U. Jeanty Cereb D CM Lat Vent Cx Len (EFW) c HC AC FL Hadlock 1 BPD AC FL Hadlock 2 AC FL Hadlock 3 BPD TTD Hansmann BPD FTA FL Osaka U. BPD AC Shepard BPD TTD APTD FL Tokyo U. a AUA b Tokyo U. APTD TTD EFW c (EFW) EFW Hadlock EFW 1 2 3 d LMP EDD 7-12
7-2 HC/AC Campbell FL/AC FL/BPD FL/HC Hadlock Hohler Hadlock Q 1, Q 2, Q 3, Q 4 Jeng d BPD Chitty, Hadlock, Jeanty HC AC FL EFW HC/AC Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Brenner, Hadlock, Jeanty Campbell a AUA b Tokyo U. APTD TTD EFW c (EFW) EFW Hadlock EFW 1 2 3 d LMP EDD 2D AFI 1 Exam Type OB 2 2D Measurements 3 OB 4 a b c 7-13
M Mode (HR) 1 Exam Type OB 2 M Mode Measurements 3 OB 4 HR HR 5 6 Save Save MSK 7-2 7-6 7-14
8 2D 10 10 8-1
8-1 a b (cm) c d < ±2% 1% < ±2% 1% < ±2% 1% < ±4% + ( 2%/) * 100 + 0.5% < ±3% + ( 1.4%/) * 100 + 0.5% 0-26 cm 0-35 cm 0-44 cm 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% 8-2
8-2 M M < ±2% + 1% a b 0-26 cm < ±2% + 1% c d 0.01-10 < ±2% + ( e * /100)% f 5-923 bpm a b 0.7 db/cm MHz RMI 413a c % = [(1 + ) * (1 + ) - 1] * 100 + 0.5% d % = [2 (2 ) * 100] + 0.5% e f FUJIFILM SonoSite (AIUM) (BSA) m 2 Grossman, W. Cardiac Catheterization and Angiography. Philadelphia: Lea and Febiger, (1980), 90. BSA = 0.007184 * 0.425 * 0.725 = = 8-3
(Ci) L/min/m 2 Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1999), 59. CI = CO/BSA CO = BSA = (CO) L/min Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 59. CO = (SV * HR)/1000 CO = SV = HR = (CSA) cm 2 Reynolds, Terry. The Echocardiographer s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 383. CSA = 0.785 * D 2 D = (EF) Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 40. EF = ((LVEDV LVESV)/LVEDV) * 100% EF = LVEDV = LVESV = 8-4
(HR) bpm HR = M 3 (IVS) Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71. IVSFT = ((IVSS - IVSD)/IVSD) * 100% IVSS = IVSD = / (LA/Ao) Feigenbaum, H. Echocardiography. Philadelphia: Lea and Febiger, (1994), 206, Figure 4-49. (Teichholz) ml Teichholz, L.E., T. Kreulen, M.V. Herman, et. al. Problems in echocardiographic volume determinations: echocardiographic-angiographic correlations in the presence or absence of asynergy. American Journal of Cardiology, (1976), 37:7. LVESV = (7.0 * LVDS 3 )/(2.4 + LVDS) LVESV = (ml) LVDS = (cm) LVEDV = (7.0 * LVDD 3 )/(2.4 + LVDD) LVEDV = (ml) LVDD = (cm) 8-5
gm Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1999), 39. LV = 1.04 [(LVID + PWT + IVST) 3 - LVID 3 ] * 0.8 + 0.6 LVID = PWT = IVST = 1.04 = 0.8 = ml Schiller, N.B., P.M. Shah, M. Crawford, et.al. Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography. Journal of American Society of Echocardiography. September-October 1989, 2:362. π V = -- 4 n i = 1 L a i b i -- n V = ml a = b = n = (n = 20) L = i = 8-6
ml Schiller, N.B., P.M. Shah, M. Crawford, et.al. Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography. Journal of American Society of Echocardiography. September-October 1989, 2:362. π V = -- 4 a 2 -- L i n i = 1 20 V = ml a = n = (n = 20) L = i = (LVD) Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Boston: Little, Brown and Company, (1994), 43-44. LVDFS = ((LVDD LVDS)/LVDD) * 100% LVDD = LVDS = (LVPWFT) Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71. LVPWFT = ((LVPWS - LVPWD)/LVPWD) * 100% LVPWS = LVPWD = 8-7
(SI) cc/m 2 Mosby's Medical, Nursing, & Allied Health Dictionary, 4th ed., (1994), 1492. SI = SV/BSA SV = BSA = M (SV) ml Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company, (1994), 44. SV = (LVEDV - LVESV) SV = LVEDV = LVESV = Raine-Fenning, N. et al. Ultrasound in Obstetrics & Gynecology (2008), Volume 31, Issue 6, John Wiley & Sons, Ltd., p.691 696. Balen, A.H., Laven, J.S., Tan, S.L, Dewailly, D. Ultrasound assessment of the polycystic ovary: international consensus definitions. Human Reproduction Update, (2003), Vol.9, No.6, p. 505-514. Wiener, J. J. and Newcombe, R. G. Measurements of uterine volume: a comparison between measurements by ultrasonography and by water displacement. J. Clin. Ultrasound, (1992) 20 (7), p. 457 460. (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), 674-677. 8-8
(AUA) AUA (AUA) (EDD) / / EDD = + (280 - AUA ) (LMP) (EDD) LMP / / EDD = LMP + 280 (EFW) Hadlock, F., et al. Estimation of Fetal Weight with the Use of Head, Body, and Femur Measurements, AProspective Study. American Journal of Obstetrics and Gynecology, 151:3 (February 1, 1985), 333-337. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 154. Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 103-105. 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), 47-54. University of Tokyo, Shinozuka, N. FJSUM, et al. Standard Values of Ultrasonographic Fetal Biometry. Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1. (LMP) LMP GA(LMP) = - LMP 8-9
(LMPd) (GA) EDD GA LMP GA(LMPd) = - LMPd (AC) Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431. University of Tokyo, Shinozuka, N. FJSUM, et al. Standard Values of Ultrasonographic Fetal Biometry. Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885. FUJIFILM SonoSite 20.0 30.0 (AC) AC AC (BPD) Chitty, L. S. and D.G. Altman. New charts for ultrasound dating of pregnancy. Ultrasound in Obstetrics and Gynecology 10: (1997), 174-179, Table 3. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 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. 8-10
(CM) Mahony, B.; P. Callen, R. Filly, and W. Hoddick. The fetal cisterna magna. Radiology, 153: (December 1984), 773-776. (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), 501-505. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 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), 174-179, Table 8, 186. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431. Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101-102. University of Tokyo, Shinozuka, N. FJSUM, et al. Standard Values of Ultrasonographic Fetal Biometry. Japanese Journal of Medical Ultrasonics, 23:12 (1996), 886. (FTA) Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99-100. 8-11
(GS) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986). 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), 174-191, Table 5, 182. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 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), 75-79 (OFD) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431. Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. Estimate of Gestational Age from Measurements of Fetal Long Bones. Journal of Ultrasound in Medicine. 3: (February 1984), 75-79. (TTD) Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431. 8-12
(AC) Chitty, Lyn S. et al. Charts of Fetal Size: 3. Abdominal Measurements. British Journal of Obstetrics and Gynaecology 101: (February 1994), 131, Appendix: AC-Derived. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Jeanty P., E. Cousaert, and F. Cantraine. Normal Growth of the Abdominal Perimeter. American Journal of Perinatology, 1: (January 1984), 129-135. ( Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 179, Table 7.13.) (BPD) Chitty, Lyn S. et al. Charts of Fetal Size: 2. Head Measurements. British Journal of Obstetrics and Gynaecology 101: (January 1994), 43, Appendix: BPD-Outer-Inner. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Jeanty P., E. Cousaert, and F. Cantraine. A Longitudinal Study of Fetal Limb Growth. American Journal of Perinatology, 1: (January 1984), 136-144, Table 5. ( Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 176, Table 7.8.) (EFW) Brenner, William E.; D. A. Edelman; C. H. Hendricks. A standard of fetal growth for the United States of America, American Journal of Obstetrics and Gynecology, 126: 5 (November 1, 1976), 555-564; Table II. Hadlock F., et al. In Utero Analysis of Fetal Growth: A Sonographic Weight Standard. Radiology, 181: (1991), 129-133. Jeanty, Philippe, F. Cantraine, R. Romero, E. Cousaert, and J. Hobbins. A Longitudinal Study of Fetal Weight Growth. Journal of Ultrasound in Medicine, 3: (July 1984), 321-328, Table 1. ( Hansmann, Hackeloer, Staudach, and Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 186, Table 7.20.) 8-13
(FL) Chitty, Lyn S. et al. Charts of Fetal Size: 4. Femur Length. British Journal of Obstetrics and Gynaecology 101: (February 1994), 135. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Jeanty P, E. Cousaert, and F. Cantraine. A Longitudinal Study of Fetal Limb Growth. American Journal of Perinatology, 1: (January 1984), 136-144, Table 5. ( Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 182, Table 7.17.) (HC) Chitty, Lyn S., et al. Charts of Fetal Size: 2. Head Measurements. British Journal of Obstetrics and Gynaecology 101: (January 1994), 43, Appendix: HC-Derived. Hadlock, F., et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology, 152: (1984), 497-501. Jeanty P, E. Cousaert, and F. Cantraine. A longitudinal study of Fetal Head Biometry. American J of Perinatology, 1: (January 1984), 118-128, Table 3. ( Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 176, Table 7.8.) (HC)/ (AC) Campbell S., Thoms Alison. Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation, British Journal of Obstetrics and Gynaecology, 84: (March 1977), 165-174. Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131. cm 3 = (4/3) * π * /2 * /2 * /2 8-14
FL/AC Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, and S.K. Park. A Date Independent Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference Ratio, American Journal of Roentgenology, 141: (November 1983), 979-984. FL/BPD Hohler, C.W., and T.A. Quetel. Comparison of Ultrasound Femur Length and Biparietal Diameter in Late Pregnancy, American Journal of Obstetrics and Gynecology, 141:7 (Dec. 1 1981), 759-762. FL/HC Hadlock F.P., R. B. Harrist, Y. Shah, and S. K. Park. The Femur Length/Head Circumference Relation in Obstetric Sonography. Journal of Ultrasound in Medicine, 3: (October 1984), 439-442. HC/AC Campbell S., Thoms Alison. Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation, British Journal of Obstetrics and Gynaecology, 84: (March 1977), 165-174. 8-15
8-16
9 LED LED M Mode 2D M Mode 2D M Mode 5-12 M SAVE Preferences 3-6 SonoSite iviz Preferences 3-6 SonoSite iviz SonoSite iviz SonoSite iviz LED SonoSite iviz 9-1
LED 2-12 LED LED 9-1 LED LED LED 60 LED 30 LED LED USB LED USB USB SonoSite iviz 9-2 The signal path has stopped because the transducer is not connected. 9-2
9-2 The temperature sensor is not working, either in the transducer or the system. The system temperature is too high. The transducer temperature is too high. 10 10 1 2 Scan Patient 1 2 3 1 2 3 Power off OK 4 FUJIFILM SonoSite 1-2 5 9-3
1 IP AE 3-1 2 3 FUJIFILM SonoSite 1-2 DICOM SonoSite iviz DICOM FAQ / DICOM Refresh Archived Status Pending Status Failed Status Not Archived Status / DICOM USB USB DICOM studies transferred successfully DICOM Studies transferred successfully USB / DICOM studies transferred successfully DICOM SonoSite iviz 100 SonoSite iviz DICOM DICOM SonoSite iviz DICOM DICOM DICOM 1 DICOM Archive Ping DICOM Ping 9-4
2 DICOM DICOM Archive Verify Ping DICOM Ping Verify DICOM a SonoSite iviz i iviz Settings iviz ii DICOM Configuration DICOM iii DICOM General iv AE IP SonoSite iviz b i Archive ii AE IP iii iv c i Worklist ii AE IP iii 3 DICOM/PACS/ SonoSite iviz DICOM DICOM 4 FUJIFILM SonoSite 1-2 5 DICOM DICOM SonoSite iviz DICOM SonoSite iviz DICOM SonoSite iviz DICOM/PACS 9-5
1 SonoSite iviz Settings 2 About iviz iviz 3 Send bug report 4 OK Wi Fi 5 OK FUJIFILM SonoSite 6 Retry Cancel 7 10 FUJIFILM SonoSite SonoSite iviz SonoSite iviz SonoSite iviz USB FUJIFILM SonoSite USB 9-6
iviz - 2D SonoSite Gammex 403GS Gammex 413A 0.7 db/cm SonoSite P21v/5-1 MHz Gammex 403 GS 413A 1 2-14 SonoSite iviz 2 3 4 5 P21v/5-1 MHz 6 7 Scan 8 9 2D 10 9-7
11 #1 1 12 SAVE 13 14 SAVE 15 1 2D P21v/5-1 MHz 2 3 #1 4 2D 5 6 7 Freeze 8 Freeze 9-8
1 2 3 Measurements 4 General 5 Distance 6 7 5-12 cm 8 9-9 9-3 1 2 3 Measurements 4 General 5 Distance 6 7 4-10 cm 8 9-9 9-3 9-3 ±2% ±2% 9-9
1 cm 1 2 3 Freeze SAVE 4 5 6 Freeze (Color) 1 P21x/5-1 MHz 2D 2 Color (ROI) 3 ROI 4 ROI 5 Depth 6 Gain ROI 7 ROI 9-10
M Mode M 1 P21x/5-1 MHz 2D 2 2D M Mode M Mode 3 M Mode 4 5 Update M Mode 6 M Mode / / 9-11
9-12
SonoSite iviz 10 SonoSite iviz FUJIFILM SonoSite 10-1
(PPE) FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite 10-2
(FDA) 10-1 10-1 10-3 A B 10-9 Spaulding Spaulding Spaulding A (PPE) 10-3
FUJIFILM SonoSite 1 a Options Power off b c d e f 10-2 10-2 a SaniCloth AF3 b Sani-Cloth Plus a b www.sonosite.com/support/cleaners-disinfectants g h i g i 10-4
2 a 10-4 10-2 b c 3 SonoSite iviz a 10-3 10-3 a Sani-Cloth AF3 b C60v L25v L38v P21v 3 Sani-Cloth Plus C60v L25v L38v P21v 3 PI-Spray II C60v L25v L38v P21v 10 a b www.sonosite.com/support/cleaners-disinfectants b c d 10-5
e f g h i c i 4 a 10-4 10-4 Cidex C60v L25v L38v P21v 25 C 45 Cidex OPA C60v L25v L38v P21v 20 C 12 www.sonosite.com/support/cleaners-disinfectants 10-6
b c d 5 a FUJIFILM SonoSite 5 cm b 5 cm 10-7
6 a 1 b 31-46 cm c 7 8 9 FUJIFILM SonoSite 10-8
B 10-3 (PPE) FUJIFILM SonoSite 1 a Options Power off b c d 10-9
e f 10-5 10-5 a SaniCloth AF3 b Sani-Cloth Plus a b www.sonosite.com/support/cleaners-disinfectants g h i g i 2 a 10-10 10-5 b c 10-10
3 iviz a 10-6 10-6 a Sani-Cloth AF3 b C60v L25v L38v P21v 3 Sani-Cloth Plus C60v L25v L38v P21v 3 PI-Spray II C60v L25v L38v P21v 10 a b www.sonosite.com/support/cleaners-disinfectants b c d 10-11
e f g h c g 4 a 10-11 10-6 b 10-12
c d e f 5 6 FUJIFILM SonoSite 10-13
iviz iviz 10-10 1 2 x 0 C +45 C 10-14
1 ISO 2 1 2 FUJIFILM SonoSite FUJIFILM SonoSite 1 2 10-15
-35 C +65 C SonoSite iviz FUJIFILM SonoSite FUJIFILM SonoSite 10-16
11 ALARA 12 11-1
(WRMSD) 1, 2, 3, 4 / WRMSD WRMSD WRMSD De Quervain 1 WRMSD WRMSD SonoSite iviz 11-2
11-3
15 WRMSD 5 1 Coffin, C.T. (2014). Work-related musculoskeletal disorders in sonographers: A review of causes and types of injury and best practices for reducing injury risk. Reports in Medical Imaging, 7, 15-26. 2 Evans, K., Roll, S., & Baker, J. (2009). Work-related musculoskeletal disorders (WRMSD) among registered diagnostic medical sonographers and vascular technologists: A representative sample. Journal of Diagnostic Medical Sonography, 25, 287-299. 3 National Institute for Occupational Safety and Health (2006). Preventing work-related musculoskeletal disorders in sonography [DHSS (NIOSH) Publication Number 2006-148]. Cincinnati, OH: Department of Health and Human Services. 4 Society of Diagnostic Medical Sonography (2003, May). Industry standard for the prevention of work-related musculoskeletal disorders in sonography. Plano, TX. 5 Alaniz, J, & Veile, B.L. (2013). Stretching for sonographers: A literature review of sonographer-reported musculoskeletal injuries. Journal of Diagnostic Medical Sonography, 29, 188-190. IEC 60601-1 SonoSite iviz 41 C 43 C 48 C 10 C 40 C -20 C 60 C 10 C 40 C 10 11-4
IEC 60601-1 II / BF 11-23 SonoSite iviz FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite / FUJIFILM SonoSite Power off FUJIFILM SonoSite 10-3 11-5
II BF II 10 FUJIFILM SonoSite SonoSite iviz 11-6
FUJIFILM SonoSite -20 C 60 C FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite SonoSite iviz FUJIFILM SonoSite 11-7
FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite ALARA MI TI FUJIFILM SonoSite 0.3 db/cm/mhz (LCD) 11-8
IEC 60601-1-2:2007 IEC 60601-1-2:2014 (EMC) 60601-1-2:2014 SonoSite iviz HF ME RF SonoSite iviz SonoSite iviz SonoSite iviz / 11-9
EMC RF (EMI) EMI EMI EMI EMI EMI EMI EMI IEC 60601-1-2 EMC FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite FUJIFILM SonoSite SonoSite iviz R&TTE (1999/5/EC) 15 (1) (2) SonoSite iviz IEEE 802.11 a/b/g/n LAN Bluetooth 4.0 2.412-2.484 GHz 5.180-5.925 GHz 2.412-2.484 GHz HT20 CCK OFDM MCS0 MCS3 MCS5 MCS7 MCS8 MCS11 MCS11 MCS13 MCS15 5.180-5.925 GHz HT20 OFDM MCS0 MCS3 MCS5 MCS7 MCS8 MCS11 MCS13 MCS15 ERP 17.9 dbm 11-10
SonoSite iviz ESD (ESD) ESD ESD ESD / RF SonoSite iviz 30 cm SonoSite iviz (RF) SonoSite iviz RF SonoSite iviz 11-1 150 khz 80 MHz d=1.2 P m 80 MHz 800 MHz d=1.2 P 800 MHz 2.5 GHz 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) P (W) 11-11
FUJIFILM SonoSite SonoSite iviz IEC 60601-1-2:2007 IEC 60601-1-2:2014 FUJIFILM SonoSite SonoSite iviz iviz 11-2 SonoSite iviz SonoSite iviz SonoSite iviz SonoSite iviz USB SonoSite iviz P21v L38v C60v L25v SonoSite iviz / USB 1.5 m 1.2 m 1.2 m 1.2 m 1.2 m =1.8 m =1.9 m 11-12
CISPR SonoSite iviz 11-3 - (IEC 60601-1-2:2007, IEC 60601-1-2:2014) RF ClSPR 11 RF ClSPR 11 RF IEC 61000-3-2 / IEC 61000-3-3 1 A SonoSite iviz B SonoSite iviz A SonoSite iviz RF SonoSite iviz SonoSite iviz 11-13
11-4 - (IEC 60601-1-2:2007) IEC 60601 (ESD) IEC 61000-4-2 ±2.0 kv ±4.0 kv ±6.0 kv ±2.0 kv ±4.0 kv ±8.0 kv ±2.0 kv ±4.0 kv ±6.0 kv ±2.0 kv ±4.0 kv ±8.0 kv 30% IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-11 N/A N/A 1 N/A N/A 1 N/A N/A 1 IEC 61000-4-8 3 A/m 3 A/m FUJIFILM SonoSite RF IEC 61000-4-6 3 Vrms 150 khz 80 MHz 3 Vrms FUJIFILM SonoSite RF d = 1.2 P 11-14
11-4 - (IEC 60601-1-2:2007) IEC 60601 d = 1.2 P 80 MHz 800 MHz RF IEC 61000-4-3 3 V/m 80 MHz 2.5 GHz 3 V/m d = 2.3 P 800 MHz 2.5 GHz P (W) d (m) 2 IEC 60417 No. 417-IEC-5140 1. SonoSite iviz iviz SonoSite iviz SonoSite iviz (EFT)/ 2. 150 khz 80 MHz 3 V/m 11-15
11-5 - (IEC 60601-1-2:2014) IEC 60601-1-2 (ESD) IEC 61000-4-2 +8 kv +2 kv +4 kv +8 kv +15 kv +2 kv +4 kv +8 kv +2 kv +4 kv +8 kv +15 kv 30% / IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-11 IEC 61000-4-11 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 N/A 1 (50/60 Hz) IEC 61000-4-8 30 A/m 30 A/m SonoSite iviz RF IEC 61000-4-6 3 Vrms 150 khz 80 MHz ISM 6 Vrms 150 khz 80 MHz ISM 6 Vrms 150 khz 80 MHz 3 Vrms 6 Vrms d=2.0 P SonoSite iviz RF d = 1.2 P 6 Vrms d=2.0 P 11-16
11-5 - (IEC 60601-1-2:2014) IEC 60601-1-2 d=1.2 P 80 MHz 800 MHz d=2.3 P 800 MHz 2.7 GHz IEC 61000-4-3 3 V/m 80 MHz 2.7 GHz 3 V/m P (W) d (m) 2 IEC 60417 No. 417-IEC-5140 60601-1-2:2014 9 60601-1-2:2014 9 1. SonoSite iviz SonoSite iviz SonoSite iviz SonoSite iviz (EFT)/ 2. 150 khz 80 MHz 3 V/m 15.247 802.11 bgn Bluetooth LE 11-17
SonoSite iviz IEC 60601-1-2 IEC 60601-2-37 SonoSite iviz SonoSite iviz SonoSite iviz 11-6 (SDO) ISO 15223-1:2016 - - 1 5.1.1 90/385/EEC 93/42/EEC 98/79/EC SN ISO 15223-1:2016 - - 1 5.1.7 REF ISO 15223-1:2016 - - 1 5.1.6 11-18
11-6 (SDO) ISO 15223-1:2016 - - 1 5.4.4 ISO 15223-1:2016 - - 1 5.3.1 ISO 15223-1:2016 - - 1 5.3.4 ISO 15223-1:2016 - - 1 5.3.7 ISO 15223-1:2016 - - 1 5.3.9 ISO 15223-1:2016 - - 1 5.3.8 ISO 7000:2014 2403 10 11-19
11-6 (SDO) / IEC 60601-1 1 ISO 15223-1:2016 - - 1 IEC 60601-1-2:2007 1-2 - - D.2-10 IEC 60601-1 5.4.3 5.1.1 11-6 FDA 11-7 FDA FDA 5-118 5-103 19-4 19-2 (SDO) ISO 15223-1:2016 - - 1 ISO 7000:2014 AAMI/ANSI ES 60601-1:2005 1 AAMI/ANSI/IEC 60601-1-2:2007 1-2 11-20
11-8 (SDO) _ UL - Underwriters Laboratories _ FCC - FCC RESY - LCM CE 93/42/EEC 17 12 2 4 5 6 (RCM) AS/NZS3820 _ C-Tick - BS EN 50419:2016 2002/96/EC (WEEE) 11(2) _ 11-21
183.1 mm 116.5 mm 26.9 mm 241.3 mm 123.0 mm 28.6 mm 161.87 mm 104.52 mm 177.8 mm 10-40 C 15-95% 700 1060 hpa 0.7 1.05-20-60 C 15-95% 500 1060 hpa 0.5 1.05 11-22
-20-60 C 15-95% 30 500 1060 hpa 0.5 1.05 USB PN P19927 100-240 VAC 0.1-0.3 A 50/60 Hz 5 VDC 2 A 10 W II 7.4 V 2.0 Ah (14.8 Wh) IPX-7 AP/APG ANSI/AAMI ES60601-1:2005/(R) 2012 A1:2012-1 3.1 CAN/CSA C22.2 No. 60601-1:2014 3.1-1 IEC 60601-1:2012 3.1-1 11-23
IEC 60601-2-37:2007-2-37 IEC 61157:1992 - JIS T0601-1:2013 (3rd Edition), Japanese Industrial Standard, General Requirements for Safety of Medical Electrical Equipment. JIS T0601-1:2013 3 EMC CISPR 11 (ISM) - - 1 B IEC 60601-1-2:2007-1-2 - - NEMA UD 2-2004 IEC 60601-2-37:2007 2-37 IEC 62359:2010 - Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. IEC 62359:2010 - - - AAMI/ANSI/ISO 10993-1:2009-1 (2009) AAMI/ANSI/ISO 10993-5 - 5 In Vitro (2009) AAMI/ANSI/ISO 10993-10 - 10 (2002) RTCA DO-160G, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118 RTCA DO-160G 21.0 B.118 11-24
DICOM NEMA PS 3.15, Digital Imaging and Communications in Medicine (DICOM) - Part 15: Security and System Management Profiles NEMA PS 3.15 (DICOM) - 15 Health Insurance and Portability and Accountability Act HIPAA 45 CFR 160, General Administrative Requirements 45 CFR 160 45 CFR 164, Security and Privacy 45 CFR 164 IEC TR 80001-2-2, Application of risk management for IT networks incorporating medical devices - part 2-2: guidance for the disclosure and communication of medical device security needs, risks and controls (2012). IEC TR 80001-2-2-2-2 FCC15.247:2015 FCC2.1093:2015 EN 301 893 EN 300 328 EN 62311:2008 EN 62209-2 / AS/NZS 4268 - RCM 11-25
11-26
ALARA 12 ALARA ALARA ALARA ALARA ALARA 2D CPD Color THI 2D ALARA 12-1
12-6 ALARA (ISPTA) 720 mw/cm 2 (MI) (TI) 1.0 MI TI ALARA MI TI BS EN 60601-2-37:2001 HH MI TI MI TI 12-3 MI TI AIUM 3 Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). 12-2
MI TI MI TI MI TI MI TI MI TI 12-1 MI C60v L25v L38v P21v MI 12-2 TI TIS TIC TIB CPD PRF C60v L25v L38v P21v MI MI 12-3
MI TI AIUM 12-5 TI MI 1.0 12-3 TI MI 1.0 2D/M Mode CPD/ C60v L25v L38v P21v MI TIC TIB TIS MI TIC TIB TIS MI TIC TIB TIS MI TIC TIB TIS MI 1.0 0.1 MI TI 0.1 TI TI TI ALARA TI FUJIFILM SonoSite AIUM TI MI TI MI 95% 95% MI MI +18% -22.4% +0.2 TI 95% 95% TI TI +21% -32.8% +0.2 MI TI 0.0 0.005 12-4
12-22 MI TI / / Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 2008. Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 2014. (A copy is included with each system.) 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. 12-5
(23 C ± 3 C) EN 60601-2-37 12-4 C C60v L25v L38v P21v 17.5 ( 27 C) 17.0 ( 27 C) 16.0 ( 27 C) 20.4 ( 27 C) 8.6 ( 10 C) 8.3 ( 10 C) 8.6 ( 10 C) 9.2 ( 10 C) 1987 10 AIUM (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement) Stowe (Journal of Ultrasound in Medicine) 2008 4 (AIUM) (NEMA UD2-2004) IEC 60601-2-37:2007-2-37 IEC 62359:2010 - - - = [e -(0.23alf) ] = = e = 2.7183 a = (db/cm MHz) 12-6
= 0.53 = 0.66 = 0.79 = 0.43 = 0.55 l = cm f = / / MHz 0.3 = [e -(0.069lf) ] 0.3 db/cm MHz 3 cm 1 db/cm MHz 12-7
1990 MI 0.1 1.0 MI 2.0 M Mode MI 1988 1990 1 C 4 C 1.5 C 7 C ISPTA 500 mw/cm 2 (AIUM, 1993) 4.3.2.1-4.3.2.6 TI MI 1.0 12-22 C60v... 12-9 C60v M... 12-10 C60v /... 12-11 L25v... 12-12 L25v M... 12-13 L25v /... 12-14 L38v /... 12-15 L38v... 12-16 L38v M... 12-17 L38v (Color)/ (CPD)... 12-18 P21v M... 12-19 P21v /... 12-20 P21v... 12-21 12-8
12-5 C60v M.I. TIS A aprt <1 A aprt >1 TIB 1.32 (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 (cm) 4.0 d eq (Z sp ) (cm) F c (MHz) 2.21 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.74 PRF (Hz) 2304 p r @PII max (MPa) 2.57 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 304 1 Abd 2 THI 3 8.2 cm 4 5 (a) <1 (b) # / TIC 12-9
12-6 C60v M M.I. TIS A aprt <1 A aprt >1 TIB 1.32 (a) (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 (cm) 4.0 d eq (Z sp ) (cm) F c (MHz) 2.21 # # # A aprt X (cm) # # # Y (cm) # # PD (μsec) 0.74 PRF (Hz) 600 p r @PII max (MPa) 2.57 d eq @Pll max (cm) # FL x (cm) # FL y (cm) # I PA.3 @MI max (W/cm 2 ) 304 1 Abd 2 THI 3 7.0 cm 4 5 (a) <1 (b) # / TIC 12-10
12-7 C60v / M.I. TIS A aprt <1 A aprt >1 TIB 1.34 (a) (b) p r.3 (MPa) 1.98 W 0 (mw) # # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) z@pii.3max (cm) 4.0 d eq (Z sp ) (cm) F c (MHz) 2.19 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 1.18 PRF (Hz) 1700 p r @PII max (MPa) 2.60 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 315 1 Abd 2 CVD 3/ / 9.6 cm 4/ H/831 Hz 5 / / (a) <1 (b) # / TIC 12-11
12-8 L25v M.I. TIS A aprt <1 A aprt >1 TIB 0.171 0.009 (b) p r.3 (MPa) 0.509 W 0 (mw) 0.206 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) z@pii.3max (cm) 1.1 d eq (Z sp ) (cm) F c (MHz) 8.89 9.23 # A aprt X (cm) 2.56 # Y (cm) 0.3 # PD (μsec) 0.102 PRF (Hz) 9216 p r @PII max (MPa) 0.701 d eq @Pll max (cm) FL x (cm) 2.7 # FL y (cm) 2.7 # I PA.3 @MI max (W/cm 2 ) 12.77 1 Oph Oph 2 Res Res 3 2.3 cm 4.9 cm 4 5 (a) <1 (b) # / TIC 12-12
12-9 L25v M M.I. TIS A aprt <1 A aprt >1 TIB 0.171 (a) 0.002 0.002 (b) p r.3 (MPa) 0.509 W 0 (mw) # 0.034 [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) 1.45 z@pii.3max (cm) 1.1 d eq (Z sp ) (cm) 0.120 F c (MHz) 8.89 # 9.12 9.18 # A aprt X (cm) # 1.16 0.64 # Y (cm) # 0.3 0.3 # PD (μsec) 0.102 PRF (Hz) 600 p r @PII max (MPa) 0.701 d eq @Pll max (cm) 0.112 FL x (cm) # 3.4 # FL y (cm) # 2.7 # I PA.3 @MI max (W/cm 2 ) 12.77 1 Oph Oph Oph 2 Res Res Res 3 1.9 cm 6.2 cm 3.3 cm 4 5 (a) <1 (b) # / TIC 12-13
12-10 L25v / M.I. TIS A aprt <1 A aprt >1 TIB 0.188 0.045 (b) p r.3 (MPa) 0.552 W 0 (mw) 1.072 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) z@pii.3max (cm) 0.95 d eq (Z sp ) (cm) F c (MHz) 8.59 8.64 # A aprt X (cm) 2.5 # Y (cm) 0.3 # PD (μsec) 0.33 PRF (Hz) 2940 p r @PII max (MPa) 0.730 d eq @Pll max (cm) FL x (cm) 3.4 # FL y (cm) 2.7 # I PA.3 @MI max (W/cm 2 ) 10.61 1 Oph Oph 2 CVD CVD 3/ / / 2.3 cm 6.2 cm 4/ H/4464 Hz H/12,500 Hz 5 / / / (a) <1 (b) # / TIC 12-14
12-11 L38v / M.I. TIS A aprt 1 A aprt >1 TIB 1.1 (a) (b) p r.3 (MPa) 2.50 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) 4.83 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.543 PRF (Hz) 2197 p r @PII max (MPa) 3.11 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 400 1 MSK 2 CVD 3/ Res/ 3 4/ / 0 5 / / (a) <1 (b) # / TIC 12-15
12-12 L38v M.I. TIS A aprt <1 A aprt >1 TIB 0.171 0.016 (b) p r.3 (MPa) 0.436 W 0 (mw) 0.514 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) z@pii.3max (cm) 1.1 d eq (Z sp ) (cm) F c (MHz) 6.51 6.57 # A aprt X (cm) 3.84 # Y (cm) 0.4 # PD (μsec) 0.198 PRF (Hz) 9216 p r @PII max (MPa) 0.552 d eq @Pll max (cm) FL x (cm) 4.3 # FL y (cm) 1.5 # I PA.3 @MI max (W/cm 2 ) 7.06 1 Oph Oph 2 Res Pen 3 2.1 cm 7.4 cm 4 5 (a) <1 (b) # / TIC 12-16
12-13 L38v M M.I. TIS A aprt <1 A aprt >1 TIB 0.170 (a) 0.005 0.006 (b) p r.3 (MPa) 0.438 W 0 (mw) # 0.170 0.170 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) 1.2 z@pii.3max (cm) 1.6 d eq (Z sp ) (cm) 0.375 F c (MHz) 6.68 # 6.57 6.57 # A aprt X (cm) # 1.44 1.44 # Y (cm) # 0.4 0.4 # PD (μsec) 0.194 PRF (Hz) 600 p r @PII max (MPa) 0.639 d eq @Pll max (cm) 0.192 FL x (cm) # 4.3 # FL y (cm) # 1.5 # I PA.3 @MI max (W/cm 2 ) 7.93 1 Oph Oph Oph 2 Res Pen Pen 3 3.1 cm 7.4 cm 7.4 cm 4 5 (a) <1 (b) # / TIC 12-17
12-14 L38v / M.I. TIS A aprt <1 A aprt >1 TIB 0.172 0.021 (b) p r.3 (MPa) 0.383 W 0 (mw) 0.867 # [W.3 (z 1 ), I TA.3 (z 1 )] (mw) z 1 (cm) Z bp (cm) Z sp (cm) z@pii.3max (cm) 1.1 d eq (Z sp ) (cm) F c (MHz) 5.00 5.02 # A aprt X (cm) 3.69 # Y (cm) 0.4 # PD (μsec) 0.621 PRF (Hz) 6503 p r @PII max (MPa) 0.461 d eq @Pll max (cm) FL x (cm) 3.69 # FL y (cm) 0.4 # I PA.3 @MI max (W/cm 2 ) 4.70 1 Oph Oph 2 CVD CVD 3/ / 2.1 cm / 5.9 cm 4/ L/391 Hz H/10,417 Hz 5 / / / (a) <1 (b) # / TIC 12-18
12-15 P21v M M.I. TIS A aprt 1 A aprt >1 TIB 1.4 (a) (a) (b) p r.3 (MPa) 1.83 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) 4.5 # # # d eq (z sp ) (cm) # # # f c (MHz) 1.81 # # # A aprt X (cm) # # # Y (cm) # 1.30 # PD (μsec) 0.919 PRF (Hz) 600 p r @PII max (MPa) 2.43 d eq @Pll max (cm) # FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 229 1 Abd 2 THI 3 3 4 (a) <1 (b) # / TIC 12-19
12-16 P21v / M.I. TIS A aprt 1 A aprt >1 TIB 1.3 (a) (b) p r.3 (MPa) 1.70 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) 1.81 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.938 PRF (Hz) 640 p r @PII max (MPa) 2.24 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 174 1 Abd 2 CVD 3/ THI/ 3 4/ / 0 5 / / (a) <1 (b) # / TIC 12-20
12-17 P21v M.I. TIS A aprt 1 A aprt >1 TIB 1.4 (a) (b) p r.3 (MPa) 1.83 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) 4.5 d eq (z sp ) (cm) f c (MHz) 1.81 # # A aprt X (cm) # # Y (cm) # # PD (μsec) 0.919 PRF (Hz) 2580 p r @PII max (MPa) 2.43 d eq @Pll max (cm) FL x (cm) # # FL y (cm) # # I PA.3 @MI max (W/cm 2 ) 299 1 OB 2 THI 3 3 4 (a <1 (b) # / TIC 12-21
6.4 12-18 % 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% A aprt d eq (z) cm 2 z z I TA (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 (x) (y) MHz (x) (y) MI W/cm 2 / z 1 / MI MI 12-22
p r @PII max PRF TI TI TIB TIC TIS W 3 (z 1 ) Wo z 1 z bp z sp MI TIB TIS TIS z 1 TIS min [(W.3 (z 1 ), I TA.3 (z) x 1 cm 2 )] z zbp 1.69 (A aprt ) MI p r.3 TIB z sp = z b.3 12-23
AIUM 2008 (Recommended Ultrasound Terminology) AIUM LCD MI/TI SonoMB TIB TIC TIS (as low as reasonably achievable, ALARA) (MI) (TI) (MI) (TI) C (60) C60xp MI MI MI 12-2 1538.5 / 1 C TI TI 12-2 / L (38) 12-24
(TDI) 12-25
12-26
IT IT 13 DICOM PACS DICOM (MWL) IT 802.11 a/b/g/n Bluetooth 4.0 DICOM PACS MWL DICOM IT 13-1
WLAN WLAN SonoSite iviz SonoSite iviz WLAN SonoSite iviz USB USB USB TCP/IP WLAN DICOM 104 2762 11112 Tricefy HTTPS / 443 HTTP 80 DICOM MWL -----------> SonoSite iviz ----------------> PACS (DICOM MWL) DICOM * DICOM 13-2 IT
IT IT 13-1 13-19 IT IT PACS PACS iviz IT PACS iviz TCP/IP DICOM MWL iviz / MWL MWL iviz TCP/IP DICOM iviz iviz iviz iviz IT 13-3
1 IT IT IEC 80001-1:2010 2 IT IT IP IT 1 13-4 IT
P22806-05 *P22806-05*