ACUSON Redwood Instructions for Use Sw Ver VA20

Product Version 2.0 Software Version VA20 ©2019-2021 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2021-07 The following trademarks are owned by Siemens Medical Solutions USA, Inc. (hereinafter "Siemens"): ACUSON, ACUSON Redwood, Auto TEQ, Clarify, DTI, eSieCalcs, eSie Left Heart, eSie Measure, eSieCrypt, eSieLink, TEQ, UltraArt, Velocity Vector Imaging, 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. Legal 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 Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 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, 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 exams.

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 measurement tools for the following exams:  Obstetric

Chapter 11

Cardiac Measurements and Calculations Description of the measurement function with procedures for using measurement tools specific to the cardiac exam.

Chapter 12

Reports Procedures for saving, modifying, and transferring exam-specific 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 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 – Virtual Touch applications – 3D and 4D volume imaging  Procedures for reviewing images and clips  Procedures for importing and exporting patient data  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  Procedures for clinical software programs – Velocity Vector Imaging – eSie Left Heart

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  Information regarding the electromagnetic compatibility (EMC) testing of this ultrasound system  Clinical references

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

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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: Intended Use, page 1-6 See also: Chapter 1, 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:  Push DEPTH.  Rotate 2D to adjust the 2D gain.  Press CALIPER to activate the measurement function.

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:  Roll the trackball to adjust the size or position.  Press the right trackball key once. Or, press the left trackball key twice.  Press a trackball key twice to anchor the ending marker.

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 Edit.  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 orange dot on the touch screen in the required direction.

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Instructions for Use

1 Introduction System Overview ... 3 Intended Use ... 7 Indications for Use Statement... 7 Operating Modes ... 8 Patient Target Groups ... 8 Intended Use Environment ... 8 Intended Users ... 9 Contraindications... 10 Transducers and Intended Applications ... 11 Principles of Operation ... 14 Clinical Benefits ... 14 Image Screen Overview ... 15 Screen Saver ... 15 Touch Screen Overview ... 17 Main Navigation Selections on the Touch Screen ... 18 Additional Selections and Symbols on the Touch Screen ... 18 Touch Screen Keyboard ... 20 Controls on the Control Panel ... 21 Annotation, Measurement, and Archive Controls ... 22 Trackball and Trackball Keys... 23 Trackball Status Indicator ... 23 Operating Mode Controls... 24 Image Format Controls ... 25 Footswitch... 26 Configuring the Ultrasound System ... 26

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON Redwood ultrasound system is designed for diagnostic use in general imaging, vascular, and cardiac imaging. The system streamlines 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 system, refer to Appendix A in this manual.

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1 Introduction

SIEMENS Healthineers

Example of the ultrasound system, front view. 1 2 3

User-adjustable monitor Gel warmer Accessories shelf. This example includes the optional printer and the optional Blu-ray/DVD/CD combination drive. 4 Auxiliary continuous wave transducer port 5 Transducer ports for array transducers 6 Lock and swivel lock for the front wheel 7 ECG port 8 Auxiliary continuous wave Doppler transducer port 9 Transducer cable hook 10 Transducer holder 11 Task lamp

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1 Introduction

Example of the ultrasound system, right front view. 1 Backlit control panel 2 Front handle 3 Front basket 4 Storage bin for transducer connectors 5 Lock and swivel lock for the rear wheel 6 Air filter 7 Speaker 8 Rear basket 9 Touch screen with USB ports 10 Rear handle for repositioning the ultrasound system

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1 Introduction

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9 3

8

4

5

6 7 Example of the ultrasound system, back view. 1 2 3 4 5 6 7

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Air intake Rear storage bin attached to the monitor Adjustable arm for the monitor Air intake and speaker Power cord hook Power panel Connections and indicators ‒ Input/output panel ‒ Ethernet port ‒ Service indicator lights Touch screen with brightness controls Monitor with controls for screen display and task lamp

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Instructions for Use

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. 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 Redwood Ultrasound System

The ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures: fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) 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.

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1 Introduction

Operating Modes 

2D-mode –











2D-mode with Harmonics imaging

Color flow Doppler –

Color (velocity)

–

Power (energy)

–

Doppler Tissue Imaging

Pulsed Wave Doppler –

Pulsed Wave Doppler Tissue Imaging

–

High Pulsed Repetition Frequency Pulsed Wave Doppler

Continuous Wave Doppler –

Steerable Continuous Wave Doppler for phased array transducers

–

Auxiliary Continuous Wave Doppler for pencil transducers

M-mode –

M-mode with Harmonics imaging

–

Anatomical M-mode

Volume Imaging

Combined Modes 

2D-mode with color



2D-mode with power



2D/Doppler



2D/Doppler with color



2D/Doppler with power



2D/M-mode



2D/M-mode with color



2D/Anatomical M-mode

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 Sonographer

Interaction with Ultrasound Equipment

Expected Experience and Other Characteristics

 Acquires diagnostic views of anatomy, blood flow, and related pathology

 Ranges from novices (for example, students) to advanced practitioners with certification in multiple subspecialties

 Performs measurements and analysis of the acquired images

 Educated in anatomy, physiology, patient care, and identification of pathology in ultrasound images

 Prepares exam data for review and interpretation by a qualified physician Radiologist and Internist

 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

 Performs invasive and noninvasive ultrasound exams  Interprets exam data, including echocardiography exam data  Writes and assembles exam findings in a report

Maternal-fetal Medicine Obstetrician or Perinatologist

Instructions for Use

 Many sonographers have a Bachelor's degree; some have advanced degrees in related health care subjects

 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  Medical doctor  Expert in diagnostic imaging, including computed tomography (CT), magnetic resonance imaging (MRI), X-ray, ultrasound, and nuclear medicine  Advanced training in imaging physics with typically four to six years of post-doctoral training in the field of cardiology

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

 Manages high-risk obstetrical patients for the safe and successful delivery of the fetus

 Writes and assembles exam findings in a report

 Skilled in interpreting ultrasound exam data

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1 Introduction

User

Interaction with Ultrasound Equipment

Expected Experience and Other Characteristics

System Administrator and Customer Service Engineer or Biomedical 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).

 Installs and configures software  Troubleshoots system hardware and software

Remote Customer Service Engineer/Remote Clinical Applications Specialist

 Delivers service or applications support through the Smart Remote Services (SRS) infrastructure

 Customer service engineers or biomedical engineers are Siemens Healthineers representatives who configure the ultrasound system during initial installation, support troubleshooting activities, and repair the system.  Remote customer service engineers or remote clinical applications specialists trained to remotely access the ultrasound system for troubleshooting, information gathering, and providing advice on the use of clinical applications and workflow.  Clinical applications specialists have additional training as an ultrasound sonographer and understand the complex workflow of a clinical environment.

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. Electromagnetic Compatibility (EMC) Note: Operating the transducer in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations, may lead to temporary degradation or interference visible on the monitor screen. A lightening of image background may be noticed while visualizing hypoechoic structures, or color spectral interference, or jitter, or horizontal lines in the image screen may occur. The transducer and the system have been designed and tested to withstand such interference and will not be permanently damaged. See also: Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration

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

Modes of Operation1

Intended Applications

Curved and Linear Array Transducers 10L4

2D, C, D, M

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

14L5

2D, C, D, M

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

18L6

2D, C, D, M

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

18H6

2D, C, D, M

 Musculoskeletal, superficial  Pediatric

5C1

2D, C, D, M

 Abdominal  Fetal  Pediatric

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1 Introduction

Transducer Name

Modes of Operation1

Intended Applications

Curved and Linear Array Transducers 9C3

2D, C, D, M

 Abdominal  Fetal  Pediatric  Musculoskeletal, conventional

7VC2

2D, C, D, M, Volume Imaging

 Abdominal  Fetal  Gynecology

Phased Array Transducers 4V1

2D, C, D, M

 Abdominal  Fetal  Pediatric

5V1

2D, C, D, M, CW

 Cardiac  Pediatric

8V3

2D, C, D, M, CW

 Cardiac  Pediatric  Abdominal

10V4

2D, C, D, M, CW

 Abdominal  Cardiac  Neonatal Cephalic  Pediatric

V5Ms

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2D, C, D, M, CW

 Transesophageal (Cardiac)

Instructions for Use