SonoSite
PX User Guide
User Guide
284 Pages
Preview
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Manufacturer
EC Authorized Representative
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FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201
FUJIFILM SonoSite B.V. Joop Geesinkweg 140 1114 AB Amsterdam, The Netherlands
FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE, NSW, 2100 Australia
CAUTION
United States federal 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. Patent: www.sonosite.com/patents
2797 P21894-06 Published May 24, 2023 Copyright © 2023 FUJIFILM SonoSite, Inc. All rights reserved.
Table of Contents Introduction ... 1 About the user guide ... 1 Getting help ... 2 Intended Use ... 3 Indications for use ... 3 Biometric Measurements ... 9 Contraindications ... 10 Getting Started ... 11 About the Sonosite PX system ... 11 Basic operating steps ... 11 Hardware features ... 12 Preparing the system ... 13 Powering the system ... 16 Inserting and removing USB devices ... 21 General interaction ... 21 Preparing transducers ... 26 On-board educational videos ... 31 Configuring the System ... 33 Navigating system settings ... 33 Returning to factory defaults ... 33 Using the system as an administrator ... 34 Logging in and out ... 43 Audio settings ... 44 Connectivity and DICOM settings ... 44 Customization settings ... 52 Date and time settings ... 55 Display information settings ... 55 Network status ... 55 Power and battery settings ... 56 General settings ... 57 System information ... 58 USB settings ... 58 Logs ... 59 Entering Patient Information ... 61 Ending the previous study ... 61 Creating a new patient ... 61 Using the worklist ... 64 Saving patient information ... 66 Editing patient information ... 66 Reviewing patient information ... 66 Scanning ... 67 Understanding imaging modes ... 67 Imaging controls ... 67 Scanning in 2D ... 67 Scanning in M Mode ... 69
Scanning in Doppler ... 70 Scanning in Color ... 73 Scanning in dual mode ... 74 Scanning in simultaneous mode ... 75 Adjusting the depth ... 75 Adjusting the gain ... 76 Zooming ... 77 Viewing frames in the cine buffer ... 77 Using the centerline ... 78 Needle profiling ... 80 Needle guide control ... 82 ECG Module ... 83 Managing Images and Clips ... 86 Saving an image or a clip ... 86 Labeling images ... 87 Printing images ... 89 Archiving and exporting images and clips ... 90 Image gallery ... 91 Measurements and Calculations ... 92 Performing measurements and calculations ... 92 Calculations and analysis packages ... 101 Managing Patient Data ... 122 Managing studies ... 122 Managing reports and worksheets ... 126 Reviewing images, clips, and measurements ... 128 Measurement References ... 131 Measurement accuracy ... 131 Measurement publications and terminology ... 132 Troubleshooting and Maintenance ... 152 Troubleshooting ... 152 Software licensing ... 153 Maintenance ... 155 Cleaning and Disinfecting ... 157 Before getting started ... 157 Determining the required cleaning and disinfecting level ... 158 Option A: Clean and disinfect system and transducer to a high-level (semi-critical uses) ... 159 Option B: Clean and disinfect the system, stand, and transducer to a low-level (non-critical uses) ... 163 Storing the transducer ... 166 Transporting the transducer ... 167 Cleaning and disinfecting accessories ... 168 Safety ... 170 Ergonomic safety ... 170 Electrical safety ... 172 Equipment safety ... 176
Battery safety ... 177 Clinical Safety ... 178 Hazardous materials ... 179 Electromagnetic compatibility ... 179 Labeling symbols ... 187 Specifications ... 193 Standards ... 195 Acoustic Output ... 197 ALARA principle ... 197 Acoustic artifacts ... 198 Output display ... 198 Transducer surface temperature rise ... 200 Acoustic output measurement ... 201 Tissue models and equipment survey ... 202 Acoustic output tables ... 203 Acoustic measurement precision and uncertainty ... 258 IT Network ... 259 Functions ... 259 Data backup ... 259 Network specifications for connecting the device ... 259 Application approved list ... 261 IT network failure recovery measures ... 261 Glossary ... 263 Index ... 274
Introduction About the user guide
The Sonosite PX User Guide provides information on preparing and using the Sonosite PX ultrasound system and on cleaning and disinfecting the system and transducers. It also provides system specifications, and safety and acoustic output information.
NOTE
We highly recommend you read the entire user guide before using the system.
This user guide is meant for users familiar with ultrasound. It does not provide training in sonography, ultrasound, or clinical practices. Before using the Sonosite PX ultrasound system, you must complete such training. For information on using accessories and peripherals, refer to the applicable accessory user guide and manufacturer’s instructions.
Document conventions
The document 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. Symbols and terms used on the system and transducers are explained in Labeling symbols [187] and the Glossary [263].
Updates
The software and hardware features described in this version of the user guide could include features that are unavailable on your version of the system. Please contact FUJIFILM Sonosite Technical Support if you need an older version of the user guide. Table 1. Updates in 3.0 Features
Description
Measure and label in review
Added the ability to measure and label [129] images after saving them
Customization
Added labeling packages to customized exam types [53]
New imaging options
Added trapezoid [68]and high pulse repetition frequency (HPRF [70])
Battery and power
Added more battery saving settings [56]
Cardiac triplex
Added simultaneous [75]imaging to the cardiac exam type
Connectivity improvements
Improved certificate management [42] and added options for dealing with connectivity issues
Introduction
1
Table 2. Updates in 2.0 Features
Description
New transducers
Added the C10-3 and T8-3 (transesophageal) transducers
New exam types and measurements
Added the prostate exam type to the IC10-3 transducer and the PIV exam type to the L12-3 transducer. Added the carotid exam type and measurements.
New worksheet capabilities
Added the ability to connect to and use Qpath worksheets
Customized exams
Added exam type customization settings
Anatomical M
Added the ability to scan in anatomical M Mode
ECG
Added the ECG accessory
Cleaning mode
Added the ability to freeze system controls before cleaning
Included the material in the user guide errata and the supplement describing 1.1 features
• P28610-02 (PIV exam type, stand battery, and barcode reader) • P29198-02 user guide corrections
Getting help
In addition to the system user guide, the following are available: • On-board educational videos • On-board help and user guide: tap an information button • FUJIFILM Sonosite Technical Support: United States and 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] United Kingdom: [email protected] Europe, Middle East, and Africa: [email protected] Asia and Pacific: [email protected]
Web
www.sonosite.com
2
Introduction
Intended Use The intended use is: Medical Diagnostic Ultrasound. The Sonosite PX ultrasound system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Indications for use Diagnostic ultrasound
The Sonosite PX 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 Sonosite PX 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. 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 indications for use tables display the clinical applications and imaging modes for the system and transducers. The predefined exam types available on each transducer are displayed in Selecting a transducer and exam type [29]. The indications for use table key applies to all the following indications for use tables. Table 3. Indications for use table key. 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
Intended Use
3
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 4. Sonosite PX 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
C
PWD
CWD
Abdominal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
Combined (spec.)
Other (spec.) c, e, f
Adult cephalic
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac adult
✓
✓
✓
✓
✓
B+M; B+PWD; B+CWD; B+C;(B+C) +PWD;(B+C)+CWD
c, d, f, g, i
Cardiac pediatric
✓
✓
✓
✓
✓
B+M; B+PWD; B+CWD; B+C;(B+C) +PWD;(B+C)+CWD
c, d, f, g, i
Fetal - OB/GYN
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Musculoskeletal (superficial)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Ophthalmic
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Peripheral vessel
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h, i
Small organ (breast, thyroid, testicles, prostate)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Transesophageal (cardiac)
✓
✓
✓
✓
✓
B+M; B+PWD; B+CWD; B+C; (B+C) +PWD; (B+C)+CWD
c, d, g
Transrectal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Transvaginal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Table 5. C5-1 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
C
PWD
CWD
Combined (spec.)
Other (spec.)
Abdominal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Cardiac adult
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Fetal - OB/GYN
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Peripheral vessel
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
NOTE
The C5-1 transducer is capable of imaging superficial MSK. The frequency is limited to 3.5 MHz.
4
Intended Use
Table 6. C10-3 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
C
PWD
CWD
Combined (spec.)
Abdominal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
Other (spec.) c, e, f
Cardiac adult
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Fetal - OB/GYN
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f
Table 7. IC10-3 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
C
PWD
CWD
Combined (spec.)
Other (spec.)
Fetal - OB/GYN
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Transrectal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Transvaginal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, e, f, h
Table 8. L12-3 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
C
PWD
CWD
Combined (spec.)
Other (spec.)
Cardiac adult
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Musculoskeletal (superficial)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Ophthalmic
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Peripheral vessel
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, i
Small organ (breast, thyroid, testicles, prostate)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Table 9. L15-4 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
C
PWD
CWD
Combined (spec.)
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Musculoskeletal (superficial)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Peripheral vessel
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, i
Small organ (breast, thyroid, testicles, prostate)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f
Intended Use
Other (spec.)
5
Table 10. L19-5 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
C
PWD
CWD
Combined (spec.)
Cardiac adult
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
Other (spec.) f
Cardiac pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Musculoskeletal (conventional)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Musculoskeletal (superficial)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Ophthalmic
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
e, f
Pediatric
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Peripheral vessel
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h, i
Small organ (breast, thyroid, testicles, prostate)
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
b, c, e, f, h
Table 11. 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
C
PWD
CWD
Abdominal
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
Combined (spec.)
Other (spec.) c, e, f
Adult cephalic
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
f
Cardiac adult
✓
✓
✓
✓
✓
B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD
c, d, f, g, i
Cardiac pediatric
✓
✓
✓
✓
✓
B+M; B+PWD; B+CWD; B+C; (B+C)+PWD; (B+C)+CWD
c, d, f, g, i
Fetal - OB/GYN
✓
✓
✓
✓
-
B+M; B+PWD; B+C; (B+C)+PWD
c, f
Table 12. 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 Transesophageal (cardiac)
2D
M
C
PWD
CWD
✓
✓
✓
✓
✓
Combined (spec.)
Other (spec.)
B+M; B+PWD; B+CWD; B+C; (B+C) +PWD; (B+C)+CWD
c, d, g
The system transmits ultrasound energy into the patient's body to obtain ultrasound images as described in the following table. Table 13. Clinical application descriptions Clinical application
Description
Exam types
Abdominal
You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures for the presence or absence of pathology transabdominally. You can assist with the performance of interventional abdominal procedures and evaluate hemodynamic blood flow in abdominal organs.
Abdomen
Adult cephalic
You can assess the anatomical structures and vascular anatomy of the brain for the presence or absence
Orbital, Transcranial
6
Intended Use
Clinical application
Description
Exam types
of pathology. You can use imaging temporally, transoccipitally, or transorbitally.
WARNING
To avoid injury to the patient, use only the Ophthalmic or Orbital exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits if the Ophthalmic or Orbital exam type is selected. Cardiac adult
You can assess the cardiac valves, the great vessels, chamber size and volume, cardiac function, hemodynamic assessment, and surrounding anatomical structures for the presence or absence of pathology. You can detect normal lung motion for the presence or absence of pathology.
Cardiac, Cardiac Resuscitation, Focused Cardiac, Lung
The FUJIFILM Sonosite ECG Module can be used only in conjunction with ultrasound imaging as a secondary function intended to provide a cardiac cycle reference to the ultrasound image. The ECG signal is displayed when the ECG Module is connected to the system, the electrodes are connected to a patient, and a compatible transducer is being used. The R-wave indicator is displayed with the signal to show the waveforms that are used to provide the heartrate.
WARNING
Do not use the FUJIFILM Sonosite ECG to diagnose cardiac arrhythmias or to provide long-term cardiac monitoring. The ECG accessory and features have non-standard labeling, scaling, and settings for the ECG waveform. Cardiac pediatric
You can assess the cardiac valves, the great vessels, chamber size and volume, cardiac function, hemodynamic assessment, and surrounding anatomical structures for the presence or absence of pathology. You can detect normal lung motion for the presence or absence of pathology.
Cardiac, Cardiac Resuscitation, Focused Cardiac, Lung,
Fetal -OB/GYN
You can assess the fetal anatomy, viability, estimated fetal weight, fetal heart rate, fetal position, gestational age, amniotic fluid, and surrounding anatomical structures for the presence or absence of pathology transabdominally.
Early OB, Gynecology, Obstetrics
You can evaluate the blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures. Color Power Doppler (CPD) and Color Velocity Doppler (CVD) imaging tools are intended to evaluate the blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures in all cases, including high-risk pregnancies. High-risk pregnancy indications include, but are not limited to, multiple pregnancies, fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and lupus. CPD and Color imaging tools are not intended as a sole means of diagnosis nor as a sole method of high-risk pregnancy screening.
Intended Use
7
Clinical application
Description
Exam types
WARNING • During the first trimester, you should limit the duration of ultrasound imaging based on MI/TI. See Acoustic Output [197] for more information. • CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool, for the diagnosis of Intrauterine Growth Restriction (IUGR). • To prevent injury or misdiagnosis, do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or In Vitro Fertilization (IVF). The system has not been validated to be proven effective for these two uses. Musculoskeletal (conventional and superficial)
You can assess musculoskeletal structures, soft tissue structures, and surrounding anatomical structures for the presence or absence of pathology.
MSK, Nerve, Spine, Superficial
Ophthalmic
You can assess the ocular structures and surrounding anatomical structures for the presence or absence of pathology.
Ophthalmic, Orbital
WARNING
To avoid injury to the patient, use only the Ophthalmic or Orbital exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits if the Ophthalmic or Orbital exam type is selected. Pediatric
You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels and surrounding anatomical structures for the presence or absence of pathology trans abdominally. You can evaluate and perform interventional abdominal procedures and evaluate blood flow in abdominal organs.
Abdomen, Arterial, MSK, Superficial, Venous
Peripheral vessel
You can assess the carotid arteries, deep veins and arteries in the arms and legs, superficial vessels in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or absence of pathology.
Arterial, Carotid, PIV, Venous
Small organs (breast, thyroid, testicles, prostate)
You can assess the breast, prostate, thyroid, testicles, lymph nodes, hernias, soft tissue structures, and surrounding anatomical structures for the presence or absence of pathology. You can demonstrate blood flow in superficial anatomical structures.
Breast, Superficial
Transesophageal (cardiac)
You can assess the cardiac valves, the great vessels, chamber size and volume, cardiac function, hemodynamic assessment, and surrounding anatomical structures for the presence or absence of pathology.
Cardiac, Cardiac Resuscitation
Transrectal
You can assess the prostate and surrounding anatomical structures for the presence or absence of pathology. You can assess blood flow in the prostate.
Prostate
Transvaginal
You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence of pathology transvaginally. You can assess blood flow in pelvic organs transvaginally.
Gynecology, Early OB, Obstetrics
During early OB, you can assess the fetal anatomy, viability, fetal heart rate, fetal position, gestational age, amniotic fluid, and surrounding anatomical structures for the presence or absence of pathology transvaginally.
8
Intended Use
Clinical application
Description
Exam types
You can evaluate the blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures. Color Power Doppler (CPD) and Color Velocity Doppler (CVD) imaging tools are intended to evaluate the blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures in all cases, including high-risk pregnancies. High-risk pregnancy indications include, but are not limited to, multiple pregnancies, fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and lupus. CPD and Color imaging tools are not intended as a sole means of diagnosis nor as a sole method of high-risk pregnancy screening.
WARNING • During the first trimester, you should limit the duration of ultrasound imaging based on MI/TI. See Acoustic Output [197] for more information. • CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool, for the diagnosis of Intrauterine Growth Restriction (IUGR). • To prevent injury or misdiagnosis, do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or In Vitro Fertilization (IVF). The system has not been validated to be proven effective for these two uses.
Biometric Measurements
You can perform the following clinical measurements on the Sonosite PX ultrasound system. Calculations include: • Volume • Volume flow • Cardiac • Carotid • Obstetrics • Ratios • Percent reduction Measurements and their references include: • Cardiac measurements • Obstetrical measurements • General measurements (such as distance, area, velocity, slope, and VTI) Measurement and analysis performance encompasses the accuracy of the caliper measurements as well as the accuracy of algorithms used to further analyze the measurements. The accuracy values require that the operator can place the caliper marker over one pixel. The values do not include acoustical anomalies of the body. Other limitations and assumptions for measurement performance are given in Sources of measurement errors [131]. Accuracy of each clinical measurement possible and the range over which this accuracy can be expected to be maintained are also found in Sources of measurement errors [131]. Intended Use
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Contraindications
The ultrasound system has no known contraindications.
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Intended Use
Getting Started WARNING
Do not use the system if it exhibits erratic or inconsistent behavior. Such behavior could indicate a hardware failure. Contact FUJIFILM Sonosite Technical Support.
About the Sonosite PX system
The ultrasound system is a portable device that acquires and displays high-resolution, real-time ultrasound images. Features available depend on your system configuration, hardware and software version, transducer, and exam type.
Basic operating steps 1. 2. 3. 4. 5.
Connect a transducer. See Preparing transducers [26]. Turn on the system. See Turning the system on and off [20]. Select the transducer and exam type, or use the default selections. See Selecting a transducer and exam type [29]. (Optional) Enter patient information. See Entering Patient Information [61]. Scan. See Scanning [67].
Getting Started
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Hardware features Figure 1. Sonosite PX
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Front view
Back view
1.
Clinical monitor
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System USB ports
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DC connector for the portable power supply (used off the stand)
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System handle
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Touch panel
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System TTC connector
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Physical controls
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Wipes and gel holders
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Cable management system
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Storage container, cord wrap, and drawer
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Stand with stand battery
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Printer
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Locking wheels (4)
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Plugs for the stand and printer power cords
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Height adjustment pedal
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Ports on the stand (USB, video out, Ethernet)
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Stand head/platform with built-in triple transducer connector (TTC)
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ECG port
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Getting Started
Front view
Back view
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20.
Transducer and barcode scanner holders
Power on/off button
Accessories and peripherals WARNING
Use only accessories and peripherals recommended by FUJIFILM Sonosite, including the power supply. Connection of accessories and peripherals not recommended by FUJIFILM Sonosite could result in electrical shock and system malfunction. Contact FUJIFILM Sonosite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM Sonosite.
The ultrasound system is designed to support a variety of accessories and peripherals. For a complete list, see Compatible accessories and peripherals [183].
Preparing the system
You can use the system on or off the stand.
WARNING
Do not lean on the ultrasound system's handle while the system is on the stand. The system could tilt suddenly, causing you to lose your balance.
Docking the system to the stand CAUTION
Disconnect any devices attached to the ultrasound system before docking it to the stand. Failure to disconnect attached devices may result in damage to the system or accessories.
1.
Make sure that the connector located on the bottom of the Triple Transducer Connect (TTC) is loose by pulling the latch down then rotating it.
Getting Started
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2.
Dock the system to the stand head or platform.
3.
Secure the system by rotating the system handle down until it clicks.
4.
Tighten the connection between the system and the TTC by pushing the connector back into place, rotating the latch in the opposite direction, then pressing it up.
Securing the Sonosite PX system to the stand
The stand head or platform has two security latches located on the back left and the back right. By default, the right latch is spring-loaded in a closed position, while the left latch is held open by an adjacent screw. You can change how the system is secured to the stand.
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Getting Started
Figure 2. Security latches and adjacent screws
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4 3 1. Left latch 2. Spring-loaded lock 3. Screws 4. Right latch Do one of the following: • To partially secure the system to the stand, leave the security latches in the default configuration. • To securely lock the system to the stand, loosen the screw holding the left latch open. Allow the latch to close, then tighten the screw. You can also tighten the screw next to the right latch. • To more easily remove the system from the stand, hold the spring-loaded latch open while tightening the adjacent screw. The latch will remain in the open position.
Removing the Sonosite PX system from the stand
CAUTION
Disconnect any devices attached to the ultrasound system before removing it from the stand. Failure to disconnect attached devices may result in damage to the system or accessories.
1. 2.
Loosen the connection between the system and the built-in Triple Transducer Connect (TTC) by pulling the latch down then rotating it. Depending on how the system is secured (see the previous section), do one of the following: • If the system is partially secured, hold the spring-loaded latch open and simultaneously pull up on the system handle.
Getting Started
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• If the system is locked to the stand, loosen the screw or screws locking one or both latches, hold the left safety latch open, and re-tighten the screw. Remove the system by holding the spring-loaded latch open and simultaneously pulling up on the system handle. • If the system is not locked to the stand, pull up on the system handle.
Adjusting the system or stand
WARNING
Lock the stand wheels whenever the system is unattended or stationary.
Do any of the following: • To lock or unlock a wheel, press down the lever on the wheel or press up on the bottom of the lever. • To adjust the angle of the stand head or platform, grasp it on both sides and tilt it up or down. • To raise or lower the stand head or platform, press down the height-adjustment pedal located at the bottom of the stand while grasping both sides of the platform and pushing it up or down.
Transporting the system 1. 2. 3.
Close the lid and lower the stand. Secure the transducers and check that the cables are clear of the floor. To wheel the system, unlock the stand’s wheels and then push forward on the handle located on the back of the stand.
Powering the system
The system can be powered by internal battery, stand battery, or by AC power.
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Getting Started