ACUSON SC2000 Instructions for Use Ver 6.5

Product Version 6.5 Software Version VC15 ©2008-2024 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2024-01 The following are trademarks of Siemens Medical Solutions USA, Inc. (hereinafter "Siemens"): ACUSON, AcuNav, ACUSON AcuNav, AcuNav CRYSTAL, ACUSON SC2000, Advanced SieClear, Cadence, Clarify, DELTA, DTI, Dynamic TCE, eSie Left Heart, eSie Lines, eSie LVA, eSie Measure, eSie PISA, eSie Slice, eSie Valves, eSie VVI, eSieCrypt, eSieScan, MultiHertz, Native, Rapid Stress, RES, SieClear, SpaceTime, SuppleFlex, SwiftLink, TCE, TEQ, TrueFusion 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 General overview of the volume imaging ultrasound system.

Chapter 2

Safety and Care Detailed information on system safety and how to care for and maintain the system and transducers.

Chapter 3

System Setup Detailed descriptions of how to transport, set up, and prepare the system for use, including transducer connection and system startup procedures.

Chapter 4

Examination Fundamentals Information on starting an examination, including instructions for entering and editing patient data and selecting an exam type, operating mode, and transducer.

Chapter 5

Physiologic Function Explanation of the Physiologic function.

Chapter 6

Transesophageal Transducer Prerequisite chapter for reading and understanding prior to the use of any transesophageal transducer. Includes recommendations for leakage current testing, electrical safety, exam considerations, and cleaning and care information.

Chapter 7

V5Ms Transesophageal Transducer Descriptions and illustrations of the articulation controls and on-screen indicators and messages for the V5Ms transesophageal transducer. Includes information on temperature controls and safeguards.

Chapter 8

V7M Transesophageal Transducer Descriptions and illustrations of the articulation controls and on-screen indicators and messages for the V7M transesophageal transducer. Includes information on temperature controls and safeguards.

Chapter 9

Z6Ms Transesophageal Transducer Descriptions and illustrations of the articulation controls and on-screen indicators and messages for the Z6Ms transesophageal transducer. Includes information on temperature controls, safeguards, and imaging functions specific to the Z6Ms transesophageal transducer.

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Appendix A

Technical Description Technical description of the ultrasound system.

Appendix B

Control Panel Explanation of all controls and keys on the control panel and alphanumeric keyboard.

Appendix C

On-screen Controls Explanation of the on-screen controls for imaging, review, measurements, and patient data management.

Appendix D

Software Program Controls Explanation of the on-screen controls for clinical software programs, for example, eSie LVA and eSie VVI.

Appendix E

Cybersecurity Information about ultrasound system security.

Appendix F

Acoustic Output Reference Acoustic output reporting tables.

Appendix G

Troubleshooting On-screen Messages

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

 Intended Audience  Technical description of the ultrasound system  Safety and care information for the system and compatible transducers  Descriptions of all system controls  Procedures for system setup and examination fundamentals  Acoustic output data

Features and Applications Reference*

 Description of image acquisition and optimization, including optional imaging features  Explanation of general and exam-specific measurements and calculations  Explanation of reviewing images, clips, and volumes  Explanation of the clinical software programs

System Reference*

 Description of customizable system settings  Information about DICOM connectivity, network capabilities, and external devices  Information about data management  Clinical references  Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration, information regarding the electromagnetic compatibility (EMC) testing of this system

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

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Conventions Take a moment to familiarize yourself with these conventions. Warnings, Cautions, and Notes

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 correct operating procedures to prevent the risk of damage to the system. Note: Notes contain information concerning the proper use of the system and/or correct execution of a procedure.

Customizable Settings

Settings available for customization are depicted as shown. Example: Use the configuration settings to adjust monitor controls. System Settings > Monitor Settings

On-screen Objects

On-screen objects such as menu selections and buttons are indicated by boldface type. Example: Click Patient Registration on the toolbar.

Keys and Controls

Controls located on the control panel with corresponding selections on the LED panel are indicated with boldface type and brackets. Example: Rotate [Maps]. Soft key controls located above the trackball on the control panel with corresponding selections on the screen are indicated with boldface type. Example: Press the THI soft key. Other keys and controls located on the control panel are indicated by uppercase, boldface type. Example: Rotate 2D. Keys located on the keyboard are indicated by boldface type. Example: Press Exam.

Selection of On-screen Objects

The SELECT key on the control panel functions as a point-and-select device (similar to a computer mouse) when used with the trackball. "Select" or "click" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press the SELECT key. "Drag" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press and hold the SELECT key. Roll the trackball to reposition the object and then release the SELECT key. The NEXT key on the control panel also functions as a point-and-select device (similar to the right button a computer mouse). "Right-click" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press the NEXT key. "Move" or "position" describes this action, the equivalent of "moving" a mouse: Roll the trackball to position the on-screen object.

Cross-References

Examples: See also: Biohazards, Safety and Care, Chapter 2, Instructions for Use See also: Alphanumeric Keyboard, p. 26

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Instructions for Use

Intended Audience The intended audience for the user and reference manuals includes the following 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

Cardiologist

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

Expected Experience and Other Characteristics  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  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

Maternal-fetal Medicine Obstetrician/ Perinatologist

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

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

Radiologist and Internist

 Performs ultrasound exams

 Medical doctors

 Interprets exam data

 Expert in diagnostic imaging, including CT, MRI, X-ray, ultrasound, and nuclear medicine

 Writes and assembles exam findings in a report

 Writes and assembles exam findings in a report

System Administrator and Customer Service Engineer

 Configures the ultrasound system for use in a networked environment

 Skilled in interpreting ultrasound exam data

 Advanced training in imaging physics with typically two to six years of post-doctoral training in the field of radiology  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 or workstation during software installation and support troubleshooting activities.

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Instructions for Use

1 Introduction System Overview ... 3 System Review ... 4 Intended Use ... 7 Indications for Use Statement... 7 Operating Modes ... 9 Patient Target Groups ... 9 Intended Use Environment ... 9 Intended Users ... 10 Contraindications... 11 Transducers and Intended Applications ... 12 Principles of Operation ... 14 Clinical Benefits ... 14 Image Screen Layout... 15 Screen Saver ... 15 Screen Lock... 15 Sample Image Screens ... 16

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON SC2000 volume imaging ultrasound system is designed for echocardiography studies. The system offers automatic workflow protocols, including Complete Adult Echo and Limited Adult Echo. You can select exam tasks from a list arranged in a logical sequence. You can save the selected tasks within each workflow protocol for reuse across multiple exams. In situations when a structured workflow is not required, you can select an open workflow protocol, such as Cardiac. When an open workflow protocol is selected, you can conduct an exam using exam tasks arranged in order without prompting from the system. The system is equipped with an integrated workstation for reviewing images and clips. The workstation is not intended to be used as an archive location. Siemens Healthineers recommends you archive data, including images and clips, to a network or an external recording medium, such as a CD/DVD, USB, or DICOM storage device. Portable system design and the user interface with a home base control panel design maximize user comfort and productivity. See also: For a technical description of the ultrasound system, refer to Appendix A in this manual.

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1 Introduction

System Review

Example of the ultrasound system. 1 User-adjustable high-resolution flat panel monitor 2 Speakers located on the control panel 3 DVD-RW drive 4 Transducer and gel holders 5 Auxiliary continuous wave transducer port 6 USB port for footswitch connector 7 Front swivel wheels 8 Front brake with directional swivel lock 9 Storage bin 10 Physio panel 11 Transducer ports and transducer parking ports 12 Transport lock for control panel 13 Cable hanger 14 Front handle 15 Control panel with alphanumeric keyboard 16 Power ON/OFF switch (flashes in Standby)

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Instructions for Use

1 Introduction

Example of the ultrasound system, back view. 1 2 3 4 5 6 7 8 9

Rear handle for repositioning the system. This handle is not intended for moving the system to another location. Location for cables on peripheral devices Rear door (access to the input/output panel) Rear swivel wheel Circuit breaker Location of equipotential connector Cable hanger Shelf USB ports located on back of control panel

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1 Introduction

Example of the ultrasound system, side view. 1

Column

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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. 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.

Indications for Use Statement Product

Indications for Use Statement

ACUSON SC2000 Ultrasound System

The ACUSON SC2000 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: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures 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. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediatric, neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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1 Introduction

Product

Indications for Use Statement Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or jugular veins in the neck; superficial and deep veins and arteries in the arms and legs; superficial and deep veins and arteries in the abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. Intraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information 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 

Volume imaging



Native Tissue Harmonic Imaging (NTHI)



Thin volume imaging



Auxiliary continuous wave Doppler



2D-mode



Color Doppler Velocity (CDV)



M-mode



Color Doppler Energy (CDE)



Pulsed wave Doppler



Doppler Tissue Energy (DTE)



Continuous wave Doppler



Doppler Tissue Velocity (DTV)



Left Ventricular Opacification (LVO)

Combined Modes 

2D/M-mode



2D/continuous wave Doppler with Color Doppler



2D/M-mode with Color Doppler



2D/Color Doppler



2D/pulsed wave Doppler



Thin volume/Color Doppler



2D/pulsed wave Doppler with Color Doppler



Volume imaging/Color Doppler



2D/continuous wave Doppler

Patient Target Groups 

Adult



Pediatric/Neonatal



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

 Responsible for acquiring diagnostic views of anatomy, blood flow and related pathology; performs measurement and analysis of those images and prepares the exam for review and reading by a qualified physician ("sonologist" or reading physician).

Cardiologist

 Responsible for interpreting diagnostic imaging studies, including echocardiography and rendering a report of findings.

Expected Experience and Other Characteristics  Experience can range from Novice (i.e., student) to Master (i.e., advanced practitioner) with certification in multiple subspecialties.  Sonographers are the primary users of ultrasound systems in the USA, Australia, and certain western European countries. They are well educated in anatomy, physiology, patient care, and in pathology identifiable by ultrasound. They are predominantly female. Educational experience is often at a Bachelor's degree level, with a small percentage holding advanced degrees in related health care fields.  The cardiologist is a Medical Doctor expert in diagnostic imaging, including CT, MRI, X-Ray, Ultrasound, and Nuclear Medicine. They are well trained in imaging physics and have typically undergone 4-6 years of post-doctoral training in the field of cardiology.  Cardiologists can perform invasive and non-invasive studies and may specialize in one vs the other. In many parts of the world, they perform the ultrasound exam as well as interpret the findings.

Interventional Cardiologist

 Interventional cardiologists are boardcertified cardiologists who perform interventional cardiology procedures, most often in a cardiac catheterization lab at a hospital.  Physician specifically trained to perform interventional or minimally invasive procedures. The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, preand post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based therapy, Interventional Cardiology techniques, Balloon angioplasty, intracoronary stent deployment, atherectomy, balloon valvuloplasty, and peripheral angioplasty.

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 The interventionalist is a Medical Doctor expert in minimally invasive procedures. They have typically undergone 4-6 years of post-doctoral training in the field of cardiology and 1-2 additional years of interventional cardiology training.

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1 Introduction

User

Interaction with Ultrasound Equipment

Electrophysiologist

 Electrophysiologists are board-certified cardiologists who perform electrophysiology procedures, most often in an electrophysiology lab at a hospital.  Physician specifically trained to perform electrophysiology procedures. The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based ablation therapies.

System Administrator/ Customer Service Engineer

 Responsible for configuration of ultrasound system for use in a networked environment.

Expected Experience and Other Characteristics  The Electrophysiologist is a Medical Doctor expert in electrophysiology procedures. They have typically undergone 4-6 years of post-doctoral training in the field of cardiology and 1-2 additional years of electrophysiology training.

 The system administrator is a person assigned within the department, or from IT, to set up the system parameters for networking to a PACS server.  The Customer Service Engineer is called upon to configure the system upon initial installation and for troubleshooting inquiries.  The system administrator may be a sonographer or a physician within the department or might be assigned to someone in the IT department.

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 the ultrasound system. Note: Certain transducers may require features not available on your system. Transducer Name

Operating Frequency

Modes of Operation*

Intended Applications

Curved Array Transducers 6C1 HD

1.8 to 5.0 MHz

2D, C, D, M

 Intraoperative Abdominal  Abdominal Vascular  Fetal Echo

Linear Array Transducers 9L4

3.5 to 9.0 MHz

2D, C, D

 Intraoperative Abdominal  Peripheral Vessel  Musculo-skeletal Conventional  Musculo-skeletal Superficial

Phased Array Transducers 4Z1c

1.7 to 2.8 MHz

2D, C, D, Volume

 Fetal  Pediatric  Cardiac

4V1c

1.75 to 4.3 MHz

2D, C, D, M, CW

 Fetal  Fetal Echo  Abdominal  Pediatric  Adult Cephalic  Cardiac  Other (Neonatal Cardiac)

8V3

2.5 to 8.0 MHz

2D, C, D, M, CW

 Fetal  Fetal Echo  Pediatric  Cardiac  Other (Neonatal Cardiac)

10V4

4.0 to 10.0 MHz

2D, C, D, M, CW

 Pediatric  Cardiac  Neonatal Cardiac

V5Ms

3.5 to 7.0 MHz

2D, C, D, M, CW

 Pediatric  Cardiac  Transesophageal

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