ACUSON Sequoia and Sequoia Select Instructions for Use Sw Ver VA10

ACUSON Sequoia Product Version 3.0 Software Version VB10 ACUSON Sequoia Select Product Version 2.0 Software Version VB10 ©2018-2023 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2023-10 The following trademarks are owned by Siemens Medical Solutions USA, Inc. (hereinafter "Siemens"): ACUSON, ACUSON Sequoia, Auto TEQ, Clarify, Sequoia, TEQ, UltraArt, Virtual Touch syngo is a trademark of Siemens Healthcare GmbH. All other product names are references to third-party products and are trademarks of their respective companies. Siemens includes references to third-party products in the user documentation for informational purposes only. Siemens does not endorse third-party products referenced in the user documentation. Siemens does not assume responsibility for the performance of third-party products. Siemens reserves the right to change its products and services at any time. In addition, this publication is subject to change without notice. Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 22010 S.E. 51st Street Issaquah, WA 98029 U.S.A. Phone: +1-888-826-9702 siemens-healthineers.com

Siemens Healthineers Headquarters Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com

Contents Chapter 1

Introduction Overview of the diagnostic ultrasound imaging system, intended use, and a detailed description of the touch screen and control panel.

Chapter 2

Safety and Care Detailed information on the safety and care of the ultrasound system. Includes information on system maintenance.

Chapter 3

Transducer Care and Accessories Detailed information on caring for transducers. Includes procedures for cleaning and disinfecting transducers. Also includes information on compatible transducer accessories.

Chapter 4

System Setup Detailed descriptions for setting up and preparing the system for use. Includes information for transporting the system.

Chapter 5

Beginning a Study Procedures for preventing unauthorized access to the ultrasound system; registering a patient; selecting a transducer, exam association, and operating mode; and capturing an image or clip.

Chapter 6

Workflow Protocols Procedures for activating and editing a protocol to guide you through a predefined clinical workflow.

Chapter 7

CINE Procedures for playing back data in the CINE memory buffer.

Chapter 8

Image Optimization Procedures for optimizing parameters for each basic operating mode. Includes procedures for creating and editing user-defined image presets.

Chapter 9

Annotations Procedures for annotating with text, directional arrows, and body markers.

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Chapter 10

Measurements and Calculations Description of the measurement function with procedures for using basic measurement tools for 2D-mode, Doppler, and M-mode. Includes the following features or measurement and calculation packages:  Obstetric

Chapter 11

Cardiac Measurements and Calculations Description of the measurement function with procedures for using measurement tools specific to the cardiac imaging use cases. Includes the following features or measurement and calculation packages:  3D Caliper  AI Measure

Chapter 12

Reports Procedures for saving, modifying, and transferring reports.

Chapter 13

Printing and Recording Procedures for printing and recording images.

Appendix A

Technical Description Technical description of the ultrasound system. Includes the operating and storage temperatures for the system and transducers.

Appendix B

Icons and Indicators Description of system status indicators, special characters, and the imaging parameters and settings on the image screen.

Appendix C

Cybersecurity Information about ultrasound system security.

Appendix D

Acoustic Output Reference Acoustic output reporting tables.

Note: Not all features and options described in this publication are available to all users. Please check with your Siemens Healthineers representative to determine the current availability of features and options.

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Instructions for Use

About the User and Reference Manuals The user and reference manuals consist of the following publications. Publication

Includes

Instructions for Use

 Conventions and typographical conventions used in the manuals  Intended audience  Introduction to the ultrasound system  Safety and care information for the ultrasound system and compatible transducers  Procedures for setting up and preparing the system for use  Procedures for registering a patient and activating an operating mode  Procedures for acquiring, optimizing, annotating, measuring, printing, and recording images  Technical description of the ultrasound system  Acoustic output data

Advanced Imaging Manual

This manual is a companion to the Instructions for Use publication and contains additional instructions for use for the safe and proper use of advanced imaging features on the ultrasound system.  Description of the biopsy function  Procedures for specialty imaging – Panoramic imaging – Contrast agent imaging – Comparing images from multiple modalities – 3D and 4D volume imaging – Virtual Touch applications – Fusion imaging  Procedures for reviewing images and clips  Description of features for cardiology – Procedures for the physiologic function – Procedures for the stress echo function – Description of the transesophageal transducer, including cleaning and care of the transducer – Cardiac volume imaging – 2D Heart AI

System Reference*

 Description of customizable system settings  Description of all measurement labels configurable for the ultrasound system  Information about DICOM connectivity, network capabilities, and external devices  Clinical references  Information regarding the electromagnetic compatibility (EMC) testing of this ultrasound system

*Languages supported by the user interface include a translation of this publication.

Instructions for Use

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Conventions The user and reference manuals include the following conventions. Convention Warnings and Cautions

Description WARNING: Warnings are intended to alert you to the importance of following the correct operating procedures where risk of injury to the patient or system user exists. Caution: Cautions are intended to alert you to the importance of following the correct operating procedures to prevent the risk of damage to the ultrasound system.

Notes and Prerequisites

Prerequisite: Prerequisites contain tasks the user must complete or information the user needs prior to performing a procedure. Note: Notes contain information concerning the proper use of the ultrasound system or correct execution of a procedure.

Cross-references

Examples: See also: For information about cleaning and disinfecting a transducer, refer to Chapter 3 in this manual. See also: For information about customizing the measurement function, refer to Chapter 2 in the System Reference. See also: For additional information about the measurement function, refer to Chapter 10 in the Instructions for Use. See also: For information about exporting and importing images, refer to Chapter B2 in the Advanced Imaging Manual. See also: Alphanumeric Keyboard, page 1-26 See also: Chapter 2, Instructions for Use

Customizable Ultrasound System Settings

Settings for configuring and customizing the ultrasound system are described in the System Reference. When customization is available, the user manual provides a reference to the configuration settings. Example: Use the configuration settings to customize the measurement function.

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Instructions for Use

Typographical Conventions The following typographical conventions are in descriptions and procedures within your user and reference manuals. Use the conventions to identify the location of a control or selection on the ultrasound system. Control or Selection

Description

Controls on the Control Panel

Controls located on the control panel are indicated by uppercase boldface type. Examples:  Rotate 2D to adjust the 2D gain.  Press ABC to activate or exit the annotation function.  Double-click UPDATE to display the 2D image.

Trackball and Trackball Keys

Right and left trackball keys are located on the control panel. The function assigned to the trackball and trackball keys is indicated by labels on the image screen. Examples:  Adjust the size or position of the field of view and then press a trackball key.  Position the measurement marker and then press a trackball key.  Press the right trackball key.

Selections on the Image Screen

On-screen selections are indicated by boldface type. Roll the trackball to position the pointer on the control or object on the image screen and then press a trackball key. Examples:  Click Correct on the patient registration form.  Double-click a thumbnail.  Select the check box for the required entries and then click Delete.

Controls on the Control Panel for the Touch Screen

Press and rotate controls on the control panel are labeled on the touch screen. The selection assigned to these controls is indicated by boldface type. Examples:  Rotate Tint.  Press Steer.

Selections on the Touch Screen

Touch screen selections are indicated by boldface type. Tap the touch screen to access a selection. Drag an object on the touch screen to reposition the object. Swipe the screen to display a separate page of selections. Examples:  Tap Workflow.  Drag the tail of the arrow on the touch screen to adjust the length.

Instructions for Use

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Instructions for Use

1 Introduction System Overview ... 3 Intended Use ... 6 Indications for Use Statement... 6 Operating Modes ... 7 Patient Target Groups ... 7 Intended Use Environment ... 7 Intended Users ... 8 Contraindications... 8 Transducers and Intended Applications ... 9 Principles of Operation ... 12 Clinical Benefits ... 12 Image Screen Overview ... 13 Screen Saver ... 13 Touch Screen Overview ... 15 Main Navigation Selections on the Touch Screen ... 17 Additional Selections and Symbols on the Touch Screen ... 17 Control Panel with Orange Backlighting ... 19 Annotation, Measurement, and Archive Controls ... 20 Trackball and Trackball Keys... 21 Trackball Status Indicator ... 21 Operating Mode Controls... 22 Image Format Controls ... 23 Control Panel with Blue Backlighting ... 24 Annotation, Measurement, and Archive Controls ... 25 Trackball and Trackball Keys... 26 Trackball Status Indicator ... 26 Operating Mode Controls... 27 Image Format Controls ... 29 Footswitch... 30 Retractable Keyboard... 30 Special Keys on the Retractable Keyboard ... 30 Configuring the Ultrasound System ... 30

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON Sequoia and ACUSON Sequoia Select ultrasound systems are designed for diagnostic use in general imaging, vascular, and cardiac imaging. The systems streamline clinical workflow from patient registration to study archival with software-based applications, transducers, and clinical communication tools. See also: For a technical description of the ultrasound systems, refer to Appendix A in this manual.

Instructions for Use

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1 Introduction

Example of the ultrasound system, front view. 1

Monitor This example includes the monitor without a luminance sensor. 2 Speaker 3 Accessory shelf. This example includes the optional printer. Accommodates an optional accessory, for example, a printer, recordable disc drive, Fusion electronics unit, or rear accessory tray 4 Lock and swivel lock for the front wheels 5 Storage bin for transducer connectors 6 Transducer ports for array transducers 7 Access door for ports ‒ Auxiliary continuous wave Doppler transducer port ‒ Auxiliary in/out port for the physiologic function ‒ ECG port 8 Transducer cable hook 9 Keyboard (optional) 10 Front handle 11 Backlit control panel 12 Transducer holder 13 Touch screen with USB ports

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1 Introduction

Example of the ultrasound system, back view. 1

Monitor This example includes the monitor without a luminance sensor. 2 Adjustable arm for the monitor 3 Storage bin 4 Accessory shelf. This example includes the optional printer. Accommodates an optional accessory, for example, a printer, recordable disc drive, Fusion electronics unit, or rear accessory tray 5 Rear handle for repositioning the ultrasound system This handle is not intended for moving the system to another location. 6 Power cord hook 7 Storage bin and access door for connections and indicators ‒ Input/output panel ‒ Ethernet port ‒ Service indicator lights 8 Rear swivel wheel with locking lever 9 Power panel 10 Gel warmer 11 Transducer holder

Instructions for Use

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1 Introduction

Intended Use WARNING: The analysis of results from an ultrasound examination requires that you are trained in the interpretation of diagnostic ultrasound studies and are qualified to make clinical diagnoses. WARNING: To avoid the risk of human injury and permanent damage to the ultrasound system, do not use the ultrasound system, transducers, or ultrasound components and accessories during magnetic resonance imaging (MRI) or in an environment with magnetic resonance (MR) equipment. WARNING: The ultrasound system is not intended for ophthalmic use. Caution: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician. Caution: Ultrasound is used as an imaging aid, but may have further restrictions specific to invitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

Indications for Use Statement Product

Indications for Use Statement

ACUSON Sequoia Ultrasound System

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal1, Pediatric, Neonatal Cephalic, Small Parts2, OB/GYN3, Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal, and Peripheral Vascular. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Sequoia Select Ultrasound System

The ACUSON Sequoia Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal1, Pediatric, Neonatal Cephalic, Small Parts2, OB/GYN3, Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal, and Peripheral Vascular. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

1 2 3

Supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis. For example: breast, testes, thyroid, penis, prostate. Useful for visualization of ovaries, follicles, uterus, and other pelvic structures.

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Instructions for Use

1 Introduction

Operating Modes 











2D-mode –

2D-mode

–

2D-mode with Harmonics Imaging

–

2D-mode with Harmonics Imaging for Contrast Agent Imaging

Color flow Doppler –

Color (velocity)

–

Power (energy)

Doppler –

Pulsed Wave Doppler

–

Pulsed Wave Doppler Tissue Imaging

–

High Pulsed Repetition Frequency Pulsed Wave Doppler

–

Steerable Continuous Wave Doppler for imaging transducers

–

Continuous Wave Doppler for non-imaging transducers

M-mode –

M-mode with Harmonics Imaging

–

Anatomical M-mode

Elastography –

Strain Imaging

–

Shear Wave Elastography

3D/4D Volume Imaging

Combined Modes 

2D-mode with color



2D-mode with Doppler



2D-mode with color and Doppler



2D-mode with M-mode



2D-mode with M-mode and color



2D-mode with Elastography



3D/4D Volume Imaging with color

Patient Target Groups 

Adult



Pediatric



Fetal

Intended Use Environment The ultrasound system is a mobile device intended for use in clinical environments. See also: For information about the environmental requirements, refer to Appendix A in this manual.

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1 Introduction

Intended Users User

Interaction with Ultrasound Equipment

Sonographer

 Acquires diagnostic views of anatomy, blood flow, and related pathology  Performs measurements and analysis of the acquired images  Prepares exam data for review and interpretation by a qualified physician

Physician

Radiologist

 Ranges from novices (for example, students) to advanced practitioners with certification in multiple subspecialties  Educated in anatomy, physiology, patient care, and identification of pathology in ultrasound images  Many sonographers have a Bachelor's degree; some have advanced degrees in related health care subjects

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

 Trained in ultrasound imaging techniques

 Writes and assembles exam findings in a report

 Skilled in interpreting ultrasound exam data

 Performs ultrasound exams

 Medical doctor

 Performs image-guided access and biopsy procedures

 Expert in diagnostic imaging, including computer tomography, magnetic resonance imaging, X-ray, ultrasound, and nuclear medicine

 Interprets exam data  Writes and assembles exam findings in a report

Cardiologist

Expected Experience and Other Characteristics

 Advanced training in imaging physics with typically two to six years of post-doctoral training in the field of radiology; some specialize in diagnostic ultrasound

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

 Expert in diagnostic imaging, including computer tomography, magnetic resonance imaging, X ray, ultrasound, and nuclear medicine

 Writes and assembles exam findings in a report

 Advanced training in imaging physics with typically two to six years of post-doctoral training in the field of cardiology; some specialize in diagnostic ultrasound System Administrator and Customer Service Engineer

 Configures the ultrasound system for use in a networked environment

 A system administrator is an individual within your organization who is designated to set up system parameters to connect the ultrasound system or workstation to a picture archiving and communication system (PACS).  Customer service engineers are Siemens Healthineers representatives who configure the ultrasound system during initial installation, support troubleshooting activities, and repair the system.

Contraindications There are no known contraindications for diagnostic ultrasound.

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1 Introduction

Transducers and Intended Applications WARNING: The ultrasound system is not intended to be used with high-frequency surgical equipment. Use of transducers in conjunction with high-frequency surgical equipment may result in an increased risk of harm to the patient in the event of a defect in the high-frequency surgical neutral electrode connection.

Only the following transducers from Siemens Healthineers are compatible with your ultrasound system. 

The following transducers are available on the ACUSON Sequoia ultrasound system: 7L2, 10L4, 14L5, 15L4, 18L6, DAX, 5C1, 7VC2, 9C2, 9C3, 11M3, 18H6, 4V1, 5V1, 8V3, 10V4, Z6T, 9EC4, 9VE4, 10EV3, CW2, CW5



The following transducers are available on the ACUSON Sequoia Select ultrasound system: 7L2, 10L4, 14L5, 15L4, 18L6, DAX, 5C1, 7VC2, 9C2, 11M3, 18H6, 4V1, 5V1, 8V3, 10V4, Z6T, 9EC4, 9VE4, 10EV3, CW2, CW5 Transducer Name

Modes of Operation1

7L2

2D, C, D, M

Intended Applications

Curved and Linear Array Transducers  Abdominal  Peripheral Vessel  Pediatric

10L4

2D, C, D, M

 Abdominal  Fetal  Musculoskeletal, conventional  Musculoskeletal, superficial  Pediatric  Peripheral Vessel  Small Organ (breast, thyroid, and testicle)  Neonatal Cephalic

14L5

2D, C, D, M

 Musculoskeletal, conventional  Musculoskeletal, superficial  Pediatric  Peripheral Vessel  Small Organ (breast, thyroid, and testicle)

15L4

2D, C, D, M

 Small Organ (breast, thyroid, and testicle)  Musculoskeletal, conventional  Musculoskeletal, superficial  Pediatric  Peripheral Vessel

18L6

2D, C, D, M

 Musculoskeletal, conventional  Musculoskeletal, superficial  Pediatric  Small Organ (breast, thyroid, and testicle)

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1 Introduction

Transducer Name

Modes of Operation1

Intended Applications

Curved and Linear Array Transducers DAX

2D, C, D, M

 Abdominal  Fetal  Pediatric

5C1

2D, C, D, M

 Abdominal  Fetal  Pediatric

7VC2

2D, C, D, M, Volume Imaging

 Abdominal  Fetal  Pediatric

9C2

2D, C, D, M

 Abdominal  Fetal  Pediatric

9C3

2D, C, D, M

 Abdominal  Fetal  Pediatric  Musculoskeletal, conventional

11M3

2D, C, D, M

 Pediatric  Neonatal Cephalic

18H6

2D, C, D, M

 Musculoskeletal, superficial  Small Organ (breast, thyroid, and testicle)  Pediatric

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Transducer Name

Modes of Operation1

Intended Applications

Phased Array Transducers 4V1

2D, C, D, M

 Abdominal  Fetal  Pediatric

5V1

2D, C, D, M, CW

 Cardiac  Pediatric  Adult Cephalic

8V3

2D, C, D, M, CW

 Cardiac  Pediatric  Abdominal  Neonatal Cephalic

10V4

2D, C, D, M, CW

 Cardiac  Neonatal Cephalic  Pediatric

Z6T

2D, C, D, M, CW, Volume Imaging

 Cardiac  Transesophageal

Endocavity Transducers 9EC4

2D, C, D, M

 Transrectal  Transvaginal

9VE4

2D, C, D, M, Volume Imaging

 Transvaginal

10EV3

2D, C, D, M

 Transvaginal

CW2

CW

Continuous Wave Transducers  Cardiac  Pediatric

CW5

Instructions for Use

CW

 Peripheral Vessel

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1 Introduction

Modes of Operation

Includes one or more of the following system operating modes:

2D (brightness mode)

2D-mode, 2D-mode with Harmonics imaging

C (color flow Doppler)

Color (velocity) or Power (energy)

D (Doppler)

Pulsed Wave Doppler, 2D/Doppler, 2D/Doppler with color, 2D/Doppler with power, 2D/Pulsed Wave Doppler Tissue Imaging

M (motion mode)

M-mode, M-mode with Harmonics imaging, 2D/M-mode, 2D/M-mode with color

CW (continuous wave Doppler)

Steerable Continuous Wave Doppler (for phased array transducers), Auxiliary Continuous Wave Doppler (for continuous wave [pencil] transducers)

Volume Imaging

3D volume imaging, 4D volume imaging

1

Principles of Operation Diagnostic ultrasound uses high-frequency (above the audible range) sound waves to produce an image of anatomical structures within the body. Electrical pulses vibrate ceramics within a transducer to transmit the sound waves into the body. Sound waves travel through body tissue at approximately 1,540 meters per second and reflect back as echoes to the transducer at each point of change in tissue density, for example, at the border of two organs in the body. These return signals provide information about the acoustic properties of the tissue. The time to receive the echo in microseconds indicates a distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image.

Clinical Benefits Ultrasound has a positive impact on the health of an individual as a non-ionizing diagnostic imaging tool. The device provides real-time anatomic and kinetic visualization of internal organs, tissue structures, blood flow, and Doppler-enabled hemodynamics. Ultrasound is the accepted imaging modality for the safe visualization of fetal anatomy and monitoring of fetal development. The mobility and cost effectiveness of ultrasound increases access to patients in clinical environments. Patient benefits also include a safer examination compared to imaging modalities using ionizing radiation. Real-time ultrasound imaging provides guidance during interventional procedures, for example, needle biopsies and fluid aspirations; in the absence of ultrasound, these procedures are conducted without visualization or with ionizing radiation.

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