User Guide
376 Pages
Preview
Page 1
User Guide
Manufacturer
EC Authorized Representative
Australia Sponsor
FUJIFILM SonoSite, Inc.
FUJIFILM SonoSite B.V.
FUJIFILM SonoSite Australasia Pty Ltd
21919 30th Drive SE
Joop Geesinkweg 140
114 Old Pittwater Road
Bothell, WA 98021 USA
1114 AB Amsterdam,
BROOKVALE, NSW, 2100
T: +1-888-482-9449 or +1-425-951-1200
The Netherlands
Australia
F: +1-425-951-1201
Caution Federal (United States) law restricts this device to sale by or on the order of a physician. SonoMB, SONOSITE, Steep Needle Profiling, and the SONOSITE logo are trademarks and registered trademarks of FUJIFILM SonoSite, Inc., in various jurisdictions. FUJIFILM is a registered trademark of FUJIFILM Corporation in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation. DICOM is a registered trademark of the National Electrical Manufacturers Association. All other trademarks are the property of their respective owners. Patents: US 11,042,696; US 10,802,547; US 10,716,542; US 10,496,137; US 9,895,133; US 9,671,491; US 9,420,998; US 9,151,832; US 8,876,719; US 8,861,822; US 8,834,372; US 8,500,647; US 8,398,408; US 8,066,642; US 7,849,250; US 7,804,970; US 7,591,786; US D904,429; US D904,428; US D904,427; US D898,922; US D625,014; US D625,015; JP 5972258; JP 6258367; JP 6322321; JP 6462164; JP 5973349; JP 6227724; JP 6850263; JP 1652769; JP 1654460; JP 1654459; JP 1655481; KR 30-1082441; KR 301097763; KR 30-1097761; KR 30 1097773; EP 2498683, validated in DE and FR; EP 1589878, validated in DE, FR, and GB; EP 2555683, validated in CH, DE, FR, GB, IE, and NL; EP 006817862-0001; EP 006817847-0001; EP 006817797 0001; EP 0068143560001; DE 602004023816; ES 2337140; IN 307120; CN 103237499; CN 101231457; CN 102753104; CN 107920797; CN 305813146; CN 305715736; CN 305661617; CN 305661618; CA 2796067; BR 112012025710-2.
Part Number: P28669-02 Publication Date: January 2022 Copyright © 2022 FUJIFILM SonoSite, Inc. All Rights reserved.
CONTENTS
1. Introduction About the Sonosite LX user guide ... 1-1 Document conventions ... 1-1 Getting help ... 1-2
2. Intended Use Indications for use ... 2-1 Diagnostic ultrasound ... 2-1 Clinical applications ... 2-2 Biometric measurements ...2-13 Contraindications ...2-13
3. Getting Started About the system ... 3-1 Basic operating steps ... 3-1 Hardware features ... 3-2 Accessories and peripherals ... 3-3 Preparing the system ... 3-4 Securing the engine to the stand ... 3-4 To remove engine from the stand ... 3-5 Adjusting the height and angle ... 3-6 Turning the system on or off ... 3-7 Putting the system into sleep mode ... 3-8 Installing or replacing the internal batteries ... 3-8 Power and battery indicators ...3-10 Inserting and removing USB devices ...3-12 General interaction ...3-14 Clinical monitor ...3-15 Digital video output ...3-16 Physical controls ...3-17 Touch panel ...3-19 On-screen keyboard ...3-20 Preparing transducers ...3-21 Connecting transducers ...3-21 Selecting a transducer and exam type ...3-23 Gel ...3-27
iii
Sheaths ... 3-27 Transporting the system ... 3-28 Educational tutorials and system help videos ... 3-28
4. Configuring the System Using the system as an administrator ... 4-2 Configuring the system for the first time ... 4-2 Accessing Administrative settings ... 4-3 Managing users on the system ... 4-4 Configuring a connection to a directory server ... 4-5 Managing password requirements ... 4-7 Protecting patient information ... 4-7 Controlling data import and export ... 4-8 Creating a sign-in notification ... 4-9 Configuring internal storage settings ... 4-9 Configuring remote worksheets access ... 4-11 Reviewing and resetting system settings ... 4-12 Logging in as a user ... 4-13 Audio settings ... 4-14 Connectivity and DICOM settings ... 4-15 About DICOM ... 4-15 Configuring the system for DICOM transfer ... 4-16 Connecting to the network ... 4-16 DICOM configuration pages ... 4-17 Associating devices with locations ... 4-21 Importing and exporting connectivity settings ... 4-23 Certificates ... 4-23 Customization settings ... 4-24 Obstetrics calculations settings ... 4-24 Abdominal calculations settings ... 4-25 Exam type customization ... 4-25 Date and Time settings ... 4-27 Display Information settings ... 4-28 Network Status settings ... 4-28 Power and Battery settings ... 4-29 General settings ... 4-29 Exporting system settings ... 4-31 System information settings ... 4-31 USB settings ... 4-31 Limitations of JPEG format ... 4-32 Logs ... 4-33
5. Entering Patient Information Ending the previous study ... 5-1
iv
Creating a new patient ... 5-2 Patient form fields ... 5-2 Using the barcode scanner ... 5-4 Using the worklist ... 5-4 Selecting a procedure ... 5-7 Saving patient information ... 5-8 Editing patient information ... 5-8 Reviewing patient information ... 5-9
6. Scanning Understanding imaging modes ... 6-1 Imaging controls ... 6-1 Scanning in 2D ... 6-2 2D imaging controls ... 6-3 Scanning in M Mode ... 6-5 Anatomical M Mode ... 6-6 M Mode imaging controls ... 6-7 Scanning in Doppler ... 6-7 Doppler modes ... 6-7 Doppler imaging controls ... 6-9 Scanning in Color ...6-11 Color types ...6-11 Color imaging controls ...6-12 Scanning in dual mode ...6-14 Scanning in simultaneous mode ...6-15 Adjusting the image ...6-16 Adjusting the depth ...6-16 Adjusting the gain ...6-16 Zooming in on an image ...6-18 Viewing frames ...6-19 Using the centerline ...6-20 Using needles ...6-22 Needle profiling ...6-22 Needle guide control ...6-24 Using the ECG ...6-25 Limitations ...6-28
7. Managing Images and Clips Saving an image or a clip ... 7-1 Labeling images ... 7-2 Setting labeling options ... 7-2 Adding text labels ... 7-3 Adding arrows ... 7-4 Adding pictographs ... 7-4
v
Using the home position ... 7-5 Deleting labels ... 7-5 Reviewing images and clips ... 7-5 Printing images ... 7-6 Archiving and exporting images ... 7-7 Exporting individual images and clips ... 7-7 Image gallery ... 7-8
8. Measurements and Calculations Performing measurements and calculations ... 8-1 Working with calipers ... 8-2 Viewing measurements and calculations ... 8-3 Reviewing measurements and calculations ... 8-3 Deleting or editing a measurement ... 8-4 Basic measurements in 2D and Color ... 8-5 Basic measurements in M Mode ... 8-8 Basic measurements in Doppler ... 8-9 Volume flow ... 8-12 Calculations and analysis packages ... 8-14 Abdominal measurements and calculations ... 8-14 Cardiac measurements and calculations ... 8-15 Carotid measurements and calculations ... 8-36 Gynecological measurements and calculations ... 8-37 Obstetrics measurements and calculations ... 8-39 MSK calculations ... 8-44
9. Managing Patient Data Managing studies ... 9-1 Using the patient list ... 9-1 Archiving studies ... 9-3 Exporting studies ... 9-5 Printing studies ... 9-6 Managing internal storage space ... 9-6 Managing reports and worksheets ... 9-7 Using worksheets ... 9-8 Custom worksheets ... 9-8 Editing a report ... 9-9 Displaying reports after the study has ended ... 9-11
10. Measurement References Measurement accuracy ... 10-1 Sources of measurement errors ... 10-2
vi
Measurement publications and terminology ...10-3 Cardiac references ...10-3 Obstetrical references ...10-17 General references ...10-20
11. Troubleshooting and Maintenance Troubleshooting ...11-1 Software licensing ...11-3 Maintenance ...11-4 System backups ...11-5 Servicing ...11-6
12. Cleaning and Disinfecting Before getting started ...12-1 Determining the required cleaning and disinfecting level ...12-2 Spaulding classifications ...12-3 Cleaning and disinfection definitions ...12-4 Option A: Clean and disinfect system, stand, and transducer to a high-level (semi-critical uses) 12-5 To clean and disinfect the system, stand, and transducer ...12-5 Option B: Clean and disinfect system, stand, and transducer to a low-level (non-critical uses) 12-10 To clean and disinfect the system, stand, and transducer ...12-11 Storing the transducer ...12-13 Transporting the transducer ...12-13 ...Cleaning and disinfecting accessories 12-15
13. Safety Ergonomic safety ...13-1 Position the system ...13-2 Position yourself ...13-2 Take breaks, exercise, and vary activities ...13-3 Electrical safety ...13-4 Electrical safety classification ...13-7 Isolating the ultrasound system and stand from power ...13-7 Equipment safety ...13-8 Battery safety ...13-10 Clinical safety ...13-11 Hazardous materials ...13-12 Electromagnetic compatibility ...13-13 Wireless transmission ...13-15 Electrostatic discharge ...13-16 Separation distance ...13-17 Compatible accessories and peripherals ...13-17
vii
Manufacturer’s declaration ... 13-19 Labeling symbols ... 13-23 Specifications ... 13-32 Dimensions ... 13-32 Environmental limits ... 13-33 Electrical ... 13-34 Batteries ... 13-34 Imaging modes ... 13-34 Image and video clip storage capacity ... 13-35 Standards ... 13-35 Electromechanical safety standards ... 13-35 EMC standards classification ... 13-36 DICOM standard ... 13-36 Security and privacy standards ... 13-36
14. Acoustic Output ALARA principle ... 14-1 Applying the ALARA principle ... 14-1 Direct, indirect, and receiver controls ... 14-2 Acoustic artifacts ... 14-3 Output display ... 14-3 MI and TI output display accuracy ... 14-4 Factors that contribute to display uncertainty ... 14-5 Related guidance documents ... 14-5 Transducer surface temperature rise ... 14-6 Acoustic output measurement ... 14-6 Tissue models and equipment survey ... 14-8 Acoustic output tables ... 14-9 Acoustic measurement precision and uncertainty ... 14-63 Terminology in acoustic output tables ... 14-63
15. IT Network Functions ... 15-1 Data backup ... 15-1 Network for connecting the device ... 15-1 Specifications for the connection ... 15-2 Hardware specification ... 15-2 Security and privacy ... 15-2 Data flow ... 15-3 Application approved list ... 15-4 IT network failure recovery measures ... 15-5
A. Glossary
viii
Terms ...A-1 Abbreviations ...A-2
B. Index
ix
x
CHAPTER 1
Introduction About the Sonosite LX user guide The Sonosite LX User Guide provides information on preparing and using the Sonosite LX ultrasound system and on cleaning and disinfecting the system and transducers. It also provides system specification, and safety and acoustic output information. Note We highly recommend you read the entire user guide before using the system.
The user guide is intended for a user familiar with ultrasound. It does not provide training in sonography, ultrasound, and clinical practices. Before using the ultrasound system, you must complete such training. For information on using accessories and peripherals, refer to the applicable FUJIFILM Sonosite accessory user guide or manufacturer’s instructions.
Document conventions The user guide follows these conventions: A
WARNING describes precautions necessary to prevent injury or loss of life.
A
Caution describes precautions necessary to protect the products.
A
Note provides supplemental information.
Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. Single-step procedures begin with .
About the Sonosite LX user guide
1-1
Symbols and terms used on the system and transducer are explained in “Labeling symbols” on page 13-23 and the “Glossary” on page A-1.
Getting help In addition to the system user guide, the following are available: Educational tutorials and system help videos. See page 3-28 On-board help and user guide: tap an information button FUJIFILM Sonosite Technical Support
1-2
United States or Canada
+1 (877) 657-8118
Europe and Middle East
Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451
Asia and Pacific
+61 2 9938 8700
Other regions
+1 (425) 951-1330, or call your local representative
Fax
+1 (425) 951-6700
General: [email protected] Europe, Middle East, and Africa: [email protected] Asia and Pacific: [email protected]
Web
www.sonosite.com
Getting help
CHAPTER 2
Intended Use
The Sonosite LX ultrasound system is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
Indications for use
2-1
The intended use is: Medical Diagnostic Ultrasound. The Sonosite LX ultrasound system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Indications for use Diagnostic ultrasound The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal
Ophthalmic
Adult cephalic
Pediatric
Cardiac adult
Peripheral vessel
Cardiac pediatric
Small organ (breast, thyroid, testicles, prostate)
Fetal - OB/GYN
Transesophageal (cardiac)
Musculoskeletal (conventional)
Transrectal
Musculoskeletal (superficial)
Transvaginal
Needle guidance This device is indicated for Prescription Use Only.
The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient’s body where needed to obtain the desired ultrasound image.
Clinical applications The following tables displays the clinical applications and imaging modes for the system and transducers. The predefined exam types available on each transducer are displayed in Table 3-2 on page 3-24.
Table 2-1: Sonosite LX diagnostic ultrasound indications for use Intended use: Clinical application Abdominal Adult cephalic Cardiac adult Cardiac pediatric
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
Musculoskeletal (conventional) Musculoskeletal (superficial) Ophthalmic Pediatric Peripheral vessel Small organ (breast, thyroid, Fetal - OB/GYN
testicles, prostate) Transesophageal (cardiac)
2-2
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
c, e, f
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+PWD; (B+C)+CWD
c, d, g
-
- - - - - -
f c, d, f, g c, d, f, g c, e, f, h b, c, e, f, h b, c, e, f, h c, e, f b, c, e, f, h b, c, e, f, h, i b, c, e, f, h
Indications for use
Table 2-1: Sonosite LX diagnostic ultrasound indications for use Intended use: Clinical application Transrectal Transvaginal
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
-
c, e, f, h
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-2: C5-1 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
Cardiac adult Cardiac pediatric Fetal - OB/GYN Musculoskeletal (conventional) Pediatric Peripheral vessel
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Abdominal
- - - - - -
f f c, e, f b, c, e, f b, c, e, f b, c, e, f
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode
Indications for use
2-3
c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Note The C5-1 transducer is capable of imaging superficial MSK. The frequency is limited to 3.5 MHz.
Table 2-3: C10-3 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
Cardiac adult Cardiac pediatric Fetal - OB/GYN Musculoskeletal (conventional) Pediatric
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Abdominal
- - - - -
f f c, e, f b, c, e, f b, c, e, f
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
2-4
Indications for use
Table 2-4: IC10-3 transducer diagnostic ultrasound indications for use Intended use: Clinical application Fetal - OB/GYN Transrectal Transvaginal
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
- -
c, e, f, h c, e, f, h
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-5: L12-3 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
Cardiac pediatric Musculoskeletal (conventional) Musculoskeletal (superficial) Ophthalmic Pediatric Peripheral vessel
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac adult
Indications for use
- - - - - -
f b, c, e, f b, c, e, f e, f b, c, e, f b, c, e, f, i
2-5
Table 2-5: L12-3 transducer diagnostic ultrasound indications for use Intended use: Clinical application Small organ (breast, thyroid, testicles, prostate)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-6: L15-4 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
Peripheral vessel Small organ
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Musculoskeletal (conventional) Musculoskeletal (superficial) Pediatric
- - - -
b, c, e, f, b, c, e, f b, c, e, f, i b, c, e, f
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
2-6
Indications for use
i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-7: L19-5 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
C
PWD
CWD
Combined (spec.)
Other (spec.)
Cardiac pediatric Musculoskeletal (conventional) Musculoskeletal (superficial) Ophthalmic Pediatric Peripheral vessel Small organ (breast, thyroid,
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac adult
- - - - - - -
testicles, prostate)
f b, c, e, f, h b, c, e, f, h e, f b, c, e, f, h b, c, e, f, h, i b, c, e, f, h
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-8: P5-1 transducer diagnostic ultrasound indications for use Intended use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa
Clinical application
2D
M
Abdominal
Indications for use
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
2-7
Table 2-8: P5-1 transducer diagnostic ultrasound indications for use Intended use: Clinical application
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa 2D
M
Cardiac pediatric Fetal - OB/GYN
Adult cephalic Cardiac adult
C
PWD
CWD
Combined (spec.)
Other (spec.)
-
f
-
B+M; B+PWD; B+C; (B+C)+PWD B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD B+M; B+PWD; B+C; (B+C)+PWD
c, d, f, g c, d, f, g c, f
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures i. B+PWD and (B+C)+PWD includes simultaneous PWD
Table 2-9: T8-3 transducer diagnostic ultrasound indications for use Intended use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of operationa
Clinical application
2D
M
Transesophageal (cardiac)
C
PWD
CWD
Combined (spec.)
Other (spec.)
B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+PWD; (B+C)+CWD
c, d, g
a. 2D = B Mode; M = M Mode including simultaneous; PWD = Pulse Wave Doppler; CWD = Continuous Wave Doppler; C = Color Doppler (Color Velocity Doppler or CVD, Color Power Doppler or CPD, Variance or Var) b. Steep Needle Profiling (SNP) = Needle enhancement in B Mode c. Tissue Harmonic Imaging (THI) d. Tissue Doppler Imaging (TDI) e. Multi-beam imaging (SonoMB) in B Mode f. Color Doppler includes Power/Velocity g. Color Doppler includes Velocity/Variance h. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures
2-8
Indications for use