ACUSON S2000 Instructions for Use Ver 2.0 June 2010

Product Version 2.0

CE Declaration

©2008-2010 Siemens Medical Solutions USA, Inc. All Rights Reserved.

This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC of June 14, 1993 concerning Medical Devices. The CE marking only applies to medical devices that have been put on the market according to the above referenced Council Directive.

June 2010 Printed in the United States of America. 3-Scape, AcuNav, ACUSON, Axius, Cadence, Clarify, Contrast Dynamics, DTI, Elastogrip, ErgoDynamic, eSieCalcs, eSieScan, eSie Touch, Evolve Package, fourSight, microCase, Multi-D, MultiHertz, S2000, SieClear, SieScape, SuppleFlex, SwiftLink, SynAps, TCE, TEQ, Vector, Velocity Vector Imaging, and Virtual Touch are trademarks of Siemens Medical Solutions USA, Inc. and syngo is a registered trademark of Siemens AG. Windows, CIDEX, CIDEX Plus, CIDEX OPA, Milton, Virkon, STERRAD and Gigasept FF are registered trademarks of their respective owners.

Unauthorized changes to this product are not covered by the CE marking and the related Declaration of Conformity. EU Authorized Representative Siemens AG Medical Solutions Henkestrasse 127 91052 Erlangen Germany

Siemens reserves the right to change system specifications at any time. Global Business Unit and Legal Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 1230 Shorebird Way Mountain View, CA 94043 U.S.A. Phone: +1-888-826-9702 www.siemens.com/healthcare

Siemens Global Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany Global Siemens Healthcare Headquarters Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare

Contents Chapter 1

Introduction General overview of the diagnostic ultrasound imaging system.

Chapter 2

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

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, imaging mode, and transducer.

Chapter 5

Transducer Accessories and Biopsy Attachment procedures for transducer accessories and an explanation of the biopsy (puncture) function, including a procedure for needle path verification.

Chapter 6

Transesophageal Transducer Description of the transesophageal transducer, including cleaning and care information for the transducer.

Chapter 7

Specialty Transducers Description of the following specialty transducers: ƒ 9EVF4

Appendix A

Technical Description Technical description of the ultrasound system.

Appendix B

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

Appendix C

On-screen Controls Explanation of all on-screen controls, including menus and soft key selections.

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 representative to determine the current availability of features and options.

Instructions for Use

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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

ƒ Technical description of the ultrasound system ƒ Safety and care information for the system and compatible transducers ƒ Descriptions of all system controls ƒ Procedures for system setup, examination fundamentals, and the biopsy function ƒ Acoustic output data

Features and Applications Reference*

ƒ Descriptions of image acquisition and optimization, including optional imaging features ƒ General and exam-specific measurements and calculations ƒ Data management ƒ Explanation of the clinical software programs for use on the ultrasound system

System Reference*

ƒ Description of customizable system settings ƒ Information about DICOM connectivity, network capabilities, and external devices ƒ Clinical references

Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration*

ƒ Information regarding the electromagnetic compatibility (EMC) testing of this system

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

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.

Cross-References

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

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Customizable System Settings

System settings available for customization are depicted as shown. Example: Use the system configuration menu to customize the registration form. System Config > Patient Registration

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.

On-screen Objects

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

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 the trackball is assigned to the pointer function. "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. "Double-click" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press the SELECT key twice. "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.

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Instructions for Use

1 Introduction System Overview ... 3 System Review... 4 Intended Use ... 6 Indications for Use Statement... 6 Transducers and Intended Applications ... 7 Image Screen Layout... 10 Screen Saver... 10 Sample Image Screens ... 11

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON S2000 ultrasound system is designed to streamline clinical workflow from image acquisition to archival in a diagnostic setting for general imaging, vascular and cardiac applications. The system supports software-based applications, exam-specific imaging presets, measurements, body markers, annotations, patient reports, and system diagnostics. The system design is based upon image quality, knowledge-based workflow, adaptive ergonomics, and innovative applications. Operating modes for the system include: ƒ

2D-mode

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2D-mode with THI (Tissue Harmonic Imaging)

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Dual mode

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2D/M-mode

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M-mode with THI

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M-mode with CDV

ƒ

Pulsed Wave Doppler

ƒ

Color Doppler Energy (CDE)

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Color Doppler Velocity (CDV)

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Steerable Continuous Wave Doppler

ƒ

Auxiliary Continuous Wave Doppler

See also: Technical Description, Appendix A, Instructions for Use

Instructions for Use

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1 Introduction

System Review

Example of the ultrasound system. 1 User-adjustable high-resolution flat panel monitor with two forward-facing speakers 2 Alphanumeric keyboard 3 User-adjustable control panel (height and swivel) 4 Front handle 5 Cable hanger 6 Transducer ports 7 Auxiliary continuous wave Doppler transducer port 8 Footswitch connector 9 Central brakes 10 Front swivel wheels 11 Parking port for transducers 12 Physio panel 13 CD/DVD-RW drive 14 Transducer and gel holders 15 Power ON/OFF (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

Rear handle Cable hanger Input/output panel with audio and video connections Rear swivel wheel with brake AC tray panel Back panel Storage bin Shelf

Instructions for Use

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1 Introduction

Intended 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.

The ACUSON S2000 ultrasound system supports the following applications: ƒ

Abdominal (Renal)

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Obstetrics (Fetal Echo)

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Gynecology

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Small Parts (Breast, Testicle, Thyroid)

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Musculoskeletal

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Pediatric (Abdomen, Infant Hip, and Neonatal Cephalic)

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Cardiac

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Vascular (Arterial and Venous)

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Digital

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Urology (Penile, Pelvis, Prostate)

Indications for Use Statement Product

Indications for Use Statement

ACUSON S2000 Ultrasound System

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging”.

ACUSON AcuNav Ultrasound Catheter

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The catheter is intended for intracardiac 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.

Instructions for Use

1 Introduction

Transducers and Intended Applications Only the following transducers from Siemens are compatible with the ultrasound system. Note: Certain transducers may require features not available on your system. 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 Transducer Name

Operating Frequency

4C1

2D-mode: 2.0 MHz–4.0 MHz

Modes of Operation*

Intended Applications

Curved and Linear Array Transducers 2D, C, D, M

Fetal, Abdominal

2D, C, D, M

Fetal, Abdominal, Pediatric, Peripheral Vessel

2D, C, D, M

Fetal, Pediatric, Small Organ, Neonatal Cephalic, Peripheral Vessel, Musculoskeletal Conventional

2D, C, D, M

Small Organ, Peripheral Vessel, Musculo-skeletal Conventional

2D, C, D, M

Intraoperative, Intraoperative Neurological, Small Organ, Peripheral Vessel, Musculo-skeletal Conventional

2D, C, D, M

Small Organ, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial

Doppler: 2.0 MHz–3.5 MHz 6C2

2D-mode: 2.5 MHz–6.0 MHz Doppler: 2.5 MHz–3.75 MHz

9L4

2D-mode: 4.0 MHz–9.0 MHz Doppler: 4.0 MHz–6.75 MHz

14L5

2D-mode: 6.0 MHz–14.0 MHz Doppler: 5.5 MHz–7.5 MHz

14L5 SP

2D-mode: 6.0 MHz–14.0 MHz Doppler: 5.5 MHz–7.5 MHz

18L6 HD

2D-mode: 7.0 MHz–16.0 MHz Doppler: 5.5 MHz–10.0 MHz

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Transducer Name

Operating Frequency

Modes of Operation*

Intended Applications

Phased Array Transducers 4V1

2D-mode: 2.0 MHz–4.0 MHz

2D, C, D, M

Fetal, Abdominal

2D, C, D, M, CW

Abdominal, Pediatric, Adult Cephalic, Cardiac, Other (Neonatal Cardiac)

2D, C, D, M, CW

Fetal, Pediatric, Neonatal Cephalic, Cardiac, Other (Neonatal Cardiac)

2D, C, D, M, CW

Fetal, Abdominal, Pediatric, Neonatal Cephalic, Cardiac, Peripheral Vessel

2D, C, D, M, CW

Fetal, Abdominal, Adult Cephalic, Cardiac

2D, C, D, M, CW

Transesophageal

2D, C, D, M, CW

Pediatric, Cardiac, Intracardiac, Other (Intraluminal)

2D, C, D, M, CW

Pediatric, Cardiac, Intracardiac, Other (Intraluminal)

Doppler: 2.0 MHz–3.5 MHz 4V1c

2D-mode: 2.0 MHz–4.5 MHz Doppler: 1.8 MHz–3.5 MHz

8V3

2D-mode: 4.0 MHz–8.0 MHz Doppler: 2.5 MHz–5.0 MHz

10V4

2D-mode: 4.0 MHz–10.0 MHz Doppler: 4.0 MHz–6.0 MHz

4P1

2D-mode: 1.75 MHz–4.0 MHz Doppler: 2.0 MHz–3.5 MHz

V5Ms

2D-mode: 3.5 MHz–7.0 MHz Doppler: 3.5 MHz–4.0 MHz

AcuNav 8F

2D-mode: 4.0 MHz–10.0 MHz Doppler: 4.0 MHz–6.5 MHz

AcuNav 10F

2D-mode: 4.0 MHz–10.0 MHz Doppler: 4.0 MHz–6.5 MHz

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Instructions for Use

1 Introduction

Transducer Name

Operating Frequency

Modes of Operation*

Intended Applications

Endocavity Transducers EV-8C4

2D-mode: 4.0 MHz–9.0 MHz

2D, C, D, M

Fetal, Abdominal, Transvaginal

2D, C, D, M

Fetal, Abdominal, Small Organ, Neonatal Cephalic, Transrectal, Transvaginal

Doppler: 4.2 MHz–6.75 MHz EC9-4

2D-mode: 4.0 MHz–8.0 MHz Doppler: 3.75 MHz–6.75 MHz

fourSight 4D Transducers 7CF2

2D-mode: 3.0 MHz–6.5 MHz

2D, C, D, M

Fetal, Abdominal

2D, C, D, M

Fetal, Neonatal Cephalic, Transvaginal

Doppler: 2.5 MHz–3.75 MHz 9EVF4

2D-mode: 4.0 MHz–9.0 MHz Doppler: 4.0 MHz–7.5 MHz

Continuous Wave Transducers CW2

2.0 MHz

CW

Adult Cephalic, Cardiac, Peripheral Vessel

CW5

5.0 MHz

CW

Adult Cephalic, Cardiac, Peripheral Vessel

*Modes of Operation

Includes one or more of the following system operating modes

2D (brightness mode)

2D-mode, 2D-mode with Tissue Harmonic Imaging (THI)

C (color flow Doppler)

Color Doppler Velocity (CDV), Color Doppler Energy (CDE)

D (Doppler)

Pulsed Wave Doppler, 2D/Doppler, 2D/Doppler with CDV, 2D/Doppler with CDE

M (motion mode)

M-mode, M-mode with THI, 2D/M-mode, 2D/M-mode with CDV, 2D/M-mode with CDE

CW (continuous wave Doppler)

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

Instructions for Use

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1 Introduction

Image Screen Layout The monitor on the ultrasound system displays clinical images together with important operating parameters, patient data, and control commands. Use the system configuration menu to customize the location of information within the patient banner. System Config > Patient Banner

Use the system configuration menu to configure the parameter settings in the imaging parameters section of the screen. System Config > Image Text Editor

Screen Saver The screen saver feature automatically freezes the system and replaces the active display with a screen-saver display after the system has been inactive for a specified number of minutes. Exit the active screen saver display by pressing any key, adjusting any control, or rolling the trackball. Use the system configuration menu to select the duration of operational inactivity needed to activate the screen saver. System Config > Basic System Note: The screen saver feature is not available when the system is in external video playback or during the Biopsy function.

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Instructions for Use

1 Introduction

Sample Image Screens

Example of a typical image screen. 1

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6 7

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Shortcut buttons. Open and close the patient registration form, patient report, patient browser, film sheet, system configuration menu, information about using the ultrasound system, and the security dialog box. The security dialog box provides access to log in as a different user of the ultrasound system or to log off the system. Patient banner. Customizable information for identifying the patient, operator, institution, date, and time. Imaging Parameters. Displays a list of imaging parameter settings for each active mode. Displays a clip icon when the clip store function is activated. Measured Results. Displays values for measurements and calculations. Thumbnail Display. Displays reference images (reduced-size images) of stored clips, images, and volumes. Use the arrows on either end of the thumbnail panel to scroll the thumbnails. Controls for printing and deleting thumbnails. Trackball status. Indicates the function currently assigned to the trackball, SELECT, UPDATE, PRIORITY, and NEXT keys on the control panel. Soft key selections for a mode or function. These labels correspond to the controls and scroll wheel on the control panel directly above the trackball.

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Image menu. Displays image optimization parameters and functions for each operating mode. Note: During combined mode imaging, click the name of the mode on the image menu to view selections specific to the mode. Use the trackball pointer to expand or collapse the display of selections for each section in the menu. During the measurement function, displays the measurement menu with mode- and exam-specific labels and measurement tools. During review, displays menu selections for image management. 10 Exam list. Selects a system or user-defined exam type. The exam type consists of a configuration of image optimization settings and a compatible transducer. 11 Transducer list. Activates a connected transducer.

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1 Introduction

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Instructions for Use

2 Safety and Care Operating Safety and Environment... 3 System Symbols... 3 Labels ... 8 Biohazard Considerations... 10 Note on Fetal Examinations ... 11 Acoustic Output - Mechanical and Thermal Indices ... 12 Mechanical and Thermal Indices... 13 Transmit Power Control... 13 Transmit Power Display... 13 Imaging Functions that Change Acoustic Output ... 14 Transducer Surface Temperature Limits ... 14 Electrical Safety... 15 Level of Protection Against Electrical Shock - System ... 16 Level of Protection Against Electrical Shock - Transducers ... 16 Defibrillators ... 17 Defibrillator Use and the ACUSON AcuNav Ultrasound Catheter ... 17 Implantable Devices ... 17 Possible Combinations with Other Equipment... 18 Maintaining Data Integrity ... 18 Caring for the Ultrasound System... 19 Daily Checklist ... 19 Maintenance ... 19 Repair... 19 Siemens Authorized Care... 20 Caring for Documentation and Storage Devices... 21 Caring for the Battery Pack... 21 Recharging the Battery Pack... 21 Battery Pack Replacement ... 21 Battery Pack Location ... 22 Removing the Battery Pack ... 23 Installing a Battery Pack ... 23 Recycling the Battery Pack... 23 Cleaning and Disinfecting ... 24 Cleaning Ultrasound System Surfaces ... 24 Cleaning the Air Filters ... 26 Caring for Transducers ... 29 Protective Case ... 30 Storage... 30 Repair... 30 Cleaning and Disinfecting Transducers ... 31 IPX8 Immersion Levels... 32 Approved List of Disinfectants ... 33 Sterilizing Transducers - 14L5 SP... 33

Instructions for Use

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2 Safety and Care

Caring for Transducer Accessories ... 34 Transducer Sheaths ... 34 Storage... 34 Gel Pad... 34 Storage... 35 Needle Guide Bracket Kits... 35 Storage and Transportation... 35 Cleaning, Disinfecting, and Sterilizing Transducer Accessories ... 36 Needle Guide Bracket Kits ... 36 Environmental Protection ... 38 Product Recycling and Disposal ... 38 Hazardous Substances ... 38 Caring for Batteries... 38 Recycling Batteries ... 39 Disposing of the Packaging Materials... 39 Disposing of Components and Accessories ... 40 Energy Conservation ... 40

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Instructions for Use