Siemens Acuson S1000, Acuson S2000, Acuson S3000 Instructions For Use Manual

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ACUSON S1000 ACUSON S2000 ACUSON S3000 Diagnostic Ultrasound System Instructions for Use

Siemens Medical Solutions USA, Inc. 11286694-ABS-001-01-01

siemens.com/healthcare

ACUSON S1000

ACUSON S2000

ACUSON S3000

Product Version VE10

ACUSON S1000, ACUSON S2000, ACUSON S3000, ACUSON S Family, Advanced fourSight, Advanced SieClear, Axius, Cadence, Clarify, Color SieScape, Contrast Dynamics, DTI, DTO, Dynamic TCE, ElastoGrip, ErgoDynamic, eSieCalcs, eSieCrypt, eSieFusion, eSieImage, eSieLink, eSieScan, eSie Touch, Evolve Package, fourSight, HELX, microCase, Multi-D, MultiHertz, SieClear, Siemens Remote Service, SieScape, SpaceTime, SuppleFlex, SwiftLink, TCE, TEQ, Vector, Velocity Vector Imaging, and Virtual Touch are trademarks of Siemens Medical Solutions USA, Inc.

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.

CE Declaration 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.

Unauthorized changes to this product are not covered by the CE marking and the related Declaration of Conformity.

EU Authorized Representative

Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany

Legal Manufacturer

Siemens Medical Solutions USA, Inc. Ultrasound 685 East Middlefield Road Mountain View, CA 94043 U.S.A. Phone: +1-888-826-9702

Siemens Healthcare Headquarters

Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 siemens.com/healthcare

Chapter 1

Introduction

Chapter 2

Safety and Care

Chapter 4

Examination Fundamentals

Chapter 6

Transesophageal Transducer

Chapter 7

Specialty Transducers

Chapter 8

Physiologic Function

Chapter 9

eSieFusion Imaging

Chapter 10

Virtual Touch Applications

General overview of the diagnostic ultrasound imaging system.

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.

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.

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

Description of the following specialty transducers:

 9EVF4

Explanation of the Physiologic function.

Explanation of eSieFusion imaging for viewing real-time ultrasound images aligned with reference data acquired using another imaging modality. Includes procedures for setting up the tracking system for eSieFusion imaging and procedures for cleaning, disinfecting, and care of the tracking system.

Explanation of the following feature and options:

 Virtual Touch imaging  Virtual Touch quantification  Virtual Touch IQ

Instructions for Use i

Appendix A

Technical Description

Technical description of the ultrasound system.

Appendix B

Control Panel and Touch Screen

Appendix C

Control Panel

Appendix D

On-screen Controls

Appendix F

Acoustic Output Reference

Description of the controls on the control panel including the special keys on the alphanumeric keyboards.

See also: An overview and example of the control panel is located in Chapter 1 of this manual.

(For systems without a touch screen)

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

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

Appendix E Advanced Feature Controls

Explanation of the on-screen controls for advanced imaging features and clinical application programs.

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.

ii Instructions for Use

About the User and Reference Manuals

Acoustic output data

Manufacturer's Declaration*

The user and reference manuals contain descriptions for the following ultrasound systems:

 ACUSON S1000 diagnostic ultrasound system  ACUSON S2000 diagnostic ultrasound system  ACUSON S3000 diagnostic ultrasound system

Features and options unique to an ultrasound system are identified in Chapter 1 and Appendix A of the Instructions for Use.

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  Technical description of the ultrasound system  Safety and care information for the system and compatible transducers  Procedures for system setup, examination fundamentals, and the biopsy function  Procedures and descriptions of specialty transducers, the physiologic function, and

the following imaging features:

– eSieFusion imaging – Virtual Touch applications

 Descriptions of system controls



Features and Applications Reference*

System Reference*  Description of customizable system settings

Electromagnetic Emissions and Immunity: Guidance and

 Descriptions of image acquisition and optimization, including optional imaging

features

 General and exam-specific measurements and calculations  Data management  Explanation of the clinical software programs for use on the ultrasound system

 Information about DICOM connectivity, network capabilities, and external devices  Clinical references  Information regarding the electromagnetic compatibility (EMC) testing of this

system

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

Instructions for Use iii

Conventions

Take a moment to familiarize yourself with these conventions.

The user and reference manuals include procedures and descriptions for ultrasound systems with and without a touch screen. Except where noted in the manuals, descriptions apply to both systems.

The following bullet symbols indicate procedures or descriptions for systems with and without a touch screen:

● This bullet symbol indicates a procedure specific to systems with a touch screen. ○ This bullet symbol indicates a procedure specific to systems without a touch screen.  This bullet symbol indicates a procedure or description for systems with and without a

touch screen. – This bullet symbol indicates a procedure or description for systems with and without a

touch screen.

Except where noted in the manuals, numbered steps apply to both systems.

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

1 Introduction

System Overview ................................................................................................ 3

System Review .............................................................................................. 4

Control Panel ...................................................................................................... 7

Example of Control Panel .............................................................................. 7

Intended Use ....................................................................................................... 9

Contraindications ........................................................................................... 9

ACUSON S1000 Ultrasound System ............................................................. 9

Indications for Use Statement .............................................................. 10

ACUSON S2000 Ultrasound System ........................................................... 11

Indications for Use Statement .............................................................. 11

ACUSON S3000 Ultrasound System ........................................................... 12

Indications for Use Statement .............................................................. 12

Transducers and Intended Applications ...................................................... 13

Image Screen Layout ........................................................................................ 19

Screen Saver ............................................................................................... 19

Sample Image Screens ............................................................................... 20

Instructions for Use 1 - 1

1 Introduction

1 - 2 Instructions for Use

1 Introduction

System Overview

The ACUSON S Family ultrasound systems are 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:

 2D-mode  2D-mode with THI (Tissue Harmonic Imaging)  Dual mode  2D/M-mode  M-mode with THI  M-mode with CDV  Pulsed Wave Doppler  Color Doppler Energy (CDE)  Color Doppler Velocity (CDV)  Steerable Continuous Wave Doppler  Auxiliary Continuous Wave Doppler

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

Instructions for Use 1 - 3

1 Introduction

System Review

Example of the ultrasound system.

1 - 4 Instructions for Use

1 Introduction

1 User-adjustable high-resolution flat panel monitor with two forward-facing speakers 2 Touch screen For systems without a touch screen, this is the location of the alphanumeric keyboard 3 User-adjustable control panel (height and swivel) 4 Front handle 5 Cable hanger 6 Retractable alphanumeric keyboard (for systems with a touch screen) 7 Transducer ports 8 Auxiliary continuous wave Doppler transducer port 9 Footswitch connector 10 Central brakes 11 Front swivel wheels 12 Parking port for transducers 13 Physio panel 14 CD/DVD-RW drive 15 Transducer and gel holders

16 Power ON/OFF (Standby)

Instructions for Use 1 - 5

1 Introduction

Example of the ultrasound system, back view.

1 Rear handle 2 Cable hanger 3 Input/output panel with audio and video connections 4 Rear swivel wheel with brake 5 AC tray panel 6 Back panel 7 Storage bin 8 Shelf

1 - 6 Instructions for Use

1 Introduction

Control Panel

The ultrasound imaging system has a combination of keys, rotary knobs, push and rotate controls, and toggle controls. A trackball provides access to on-screen objects. The keys and controls are logically arranged to require a minimum number of hand and eye movements.

Example of Control Panel

Example of the control panel and touch screen on the ultrasound system.

1 Power on/off For systems without a touch screen, the power on/off control, the backlighting and task lighting control,

the volume control and microphone control, and transmit power control are located above the alphanumeric keyboard.

Instructions for Use 1 - 7

1 Introduction

2 Touch screen with selections for each operating mode's optimization parameters and functions,

measurement labels and tools, review selections, and selections for exam types and transducers. You can tap the touch screen to make a selection.

Six controls are located on the control panel with corresponding selections on the touch screen. Press,

rotate, or press and then rotate these controls to select a setting.

For systems without a touch screen, six controls on the control panel have corresponding selections on

the LED panel. Additionally, the image menu includes the mode-specific optimization parameters and functions, measurement labels and tools, review selections, and the access to exam types and transducers.

For systems without a touch screen, this location includes soft key selections available for the active

mode or function. Soft key selections correspond to the controls and scroll wheel on the control panel

directly above the trackball. 3 Doppler audio volume control For systems without a touch screen, this control includes a microphone and is located above the

alphanumeric keyboard.

1 - 8 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.

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

in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

Contraindications

The ultrasound system is not intended for ophthalmic use or any ophthalmic application causing the acoustic beam to pass through the eye.

ACUSON S1000 Ultrasound System

The ACUSON S1000 ultrasound system supports the following applications:

 Abdominal (Renal)  Obstetrics (Fetal Echo)  Gynecology  Small Parts (Breast, Testicle, Thyroid)  Musculoskeletal  Pediatric (Abdomen, Infant Hip, and Neonatal Cephalic)  Cardiac  Vascular (Arterial and Venous)  Digital  Urology (Penile, Pelvis, Prostate)

Instructions for Use 1 - 9

1 Introduction

adult and pediatric patients.

Indications for Use Statement

Product Indications for Use Statement

ACUSON S1000 Ultrasound System

syngo Arterial Health Package (AHP)

ACUSON AcuNav Ultrasound Catheter

The S1000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), 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, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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 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."

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

1 - 10 Instructions for Use

1 Introduction

Product

Indications for Use Statement

ACUSON S2000 Ultrasound System

The ACUSON S2000 ultrasound system supports the following applications:

Indications for Use Statement

ACUSON S2000 Ultrasound System

syngo Arterial Health Package (AHP)

ACUSON AcuNav Ultrasound Catheter

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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 - 11

1 Introduction

Product

Indications for Use Statement

ACUSON S3000 Ultrasound System

The ACUSON S3000 ultrasound system supports the following applications:

Indications for Use Statement

ACUSON S3000 Ultrasound System

syngo Arterial Health Package (AHP)

ACUSON AcuNav Ultrasound Catheter

The S3000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

1 - 12 Instructions for Use

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

Transducers and Intended Applications

Refer to the table below for transducers compatible with these ultrasound systems:

 ACUSON S1000 ultrasound system  ACUSON S2000 ultrasound system  ACUSON S3000 ultrasound system

Only the following transducers from Siemens are compatible with your ultrasound 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

WARNING: In accordance with Canadian law, the 14L5 SP transducer is not licensed for use

with the ACUSON S1000 ultrasound system or the ACUSON S3000 ultrasound system.

Curved and Linear Array Transducers

4C1

6C2

9L4

12L4

2D-mode:

2.0 MHz–4.5 MHz Doppler:

2.0 MHz–3.5 MHz

2D-mode:

2.5 MHz–6.0 MHz Doppler:

2.5 MHz–3.75 MHz

2D-mode:

4.0 MHz–9.0 MHz Doppler:

4.0 MHz–6.75 MHz

2D-mode:

6.0 MHz–12.0 MHz Doppler:

4.0 MHz–7.5 MHz

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  Musculo-skeletal Conventional

2D, C, D, M  Pediatric

 Small Organ  Peripheral Vessel  Musculo-skeletal Conventional

Instructions for Use 1 - 13

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

(Available only on the ACUSON S2000 system and the ACUSON S3000 system)

Curved and Linear Array Transducers

14L5

14L5 SP

18L6 HD

6C1 HD

8C3 HD

2D-mode:

6.0 MHz–14.0 MHz Doppler:

5.5 MHz–7.5 MHz

2D-mode:

6.0 MHz–14.0 MHz Doppler:

5.5 MHz–9.0 MHz

2D-mode:

7.0 MHz–17.0 MHz Doppler:

5.5 MHz–10.0 MHz

Curved and Linear Array Transducers

2D-mode:

1.5 MHz–5.5 MHz Doppler:

2.0 MHz–3.5 MHz

2D-mode:

3.0 MHz–8.0 MHz Doppler:

2.85 MHz–3.75 MHz

2D, C, D, M  Small Organ

 Peripheral Vessel  Musculo-skeletal Conventional

2D, C, D, M  Intraoperative

 Small Organ  Peripheral Vessel  Musculo-skeletal Conventional

2D, C, D, M  Small Organ

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

2D, C, D, M  Fetal

 Abdominal

2D, C, D, M  Fetal

 Abdominal  Pediatric  Small Organ  Peripheral Vessel

1 - 14 Instructions for Use

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

Other (Neonatal Cardiac)

Phased Array Transducers

4V1

4V1c

8V3

10V4

4P1

2D-mode:

2.0 MHz–4.5 MHz Doppler:

2.0 MHz–3.5 MHz

2D-mode:

1.75 MHz–4.64 MHz Doppler:

1.8 MHz–3.5 MHz

2D-mode:

4.0 MHz–8.0 MHz Doppler:

2.5 MHz–5.0 MHz

2D-mode:

4.0 MHz–10.0 MHz Doppler:

4.5 MHz–6.0 MHz

2D-mode:

1.75 MHz–4.64 MHz Doppler:

2.0 MHz–3.5 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



2D, C, D, M, CW  Fetal

 Abdominal  Pediatric  Neonatal Cephalic  Cardiac  Peripheral Vessel

2D, C, D, M, CW  Fetal

 Abdominal  Adult Cephalic  Cardiac

Instructions for Use 1 - 15

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

4.2 MHz–6.75 MHz

Phased Array Transducers

V5Ms

V7M

AcuNav 8F

AcuNav 10F

EV-8C4

2D-mode:

4.0 MHz–7.0 MHz Doppler:

3.5 MHz–4.0 MHz

2D-mode:

4.0 MHz–8.0 MHz Doppler:

3.5 MHz–4.75 MHz 2D-mode:

4.0 MHz–10.0 MHz Doppler:

4.0 MHz–6.5 MHz

2D-mode:

4.0 MHz–10.0 MHz Doppler:

4.0 MHz–6.5 MHz

2D-mode:

4.0 MHz–9.0 MHz Doppler:

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)

Endocavity Transducers

2D, C, D, M  Fetal

 Abdominal  Transvaginal

EC9-4

MC9-4

2D-mode:

4.0 MHz–8.0 MHz Doppler:

3.75 MHz–6.75 MHz

2D-mode:

4.0 MHz–8.0 MHz Doppler:

3.75 MHz–6.75 MHz

2D, C, D, M  Fetal

 Abdominal  Small Organ  Neonatal Cephalic  Transrectal  Transvaginal

2D, C, D, M  Fetal

 Abdominal  Small Organ  Neonatal Cephalic  Transrectal  Transvaginal

1 - 16 Instructions for Use

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

fourSight 4D Transducers

7CF1

7CF2

9EVF4

2D-mode:

3.0 MHz–7.0 MHz Doppler:

2.5 MHz–3.75 MHz

2D-mode:

3.0 MHz–7.0 MHz Doppler:

2.5 MHz–3.75 MHz

2D-mode:

4.0 MHz–9.0 MHz Doppler:

4.0 MHz–7.5 MHz

2D, C, D, M  Fetal

 Abdominal

2D, C, D, M  Fetal

 Abdominal

2D, C, D, M  Fetal

 Neonatal Cephalic  Transvaginal

Instructions for Use 1 - 17

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

(Available on the ACUSON S1000 system, ACUSON S2000 system, and ACUSON S3000 system)

Operating Frequency

Range of selectable operating frequencies for:

Modes of Operation

Includes one or more of the following system operating modes

Continuous Wave Transducers

CW2

2.0 MHz CW  Adult Cephalic

 Cardiac  Peripheral Vessel

CW5

5.0 MHz CW  Adult Cephalic

 Cardiac  Peripheral Vessel

2D-mode Fundamental and harmonic imaging, not including contrast Doppler Pulsed wave, continuous wave, and color imaging

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)

1 - 18 Instructions for Use

1 Introduction

Image Screen Layout

The monitor on the ultrasound system displays clinical images together with important operating parameters and patient data.

You can hide the thumbnail panel to increase the space available on the screen for the image.

For systems without a touch screen, you can also hide the soft key selections and menu located on the left side of the screen.

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. When the security package is activated on the ultrasound system, a user name and password are required to exit the active screen-saver display and access the system.

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.

Instructions for Use 1 - 19

1 Introduction

1 Toolbar buttons. Displays controls for system functions,

8 Trackball status. Indicates the function currently

Sample Image Screens

Example of a typical image screen.

for example, displaying or hiding the menu, accessing the patient browser, and displaying information about using the ultrasound system.

Displays the security icon when the security package is

activated.

2 Measured Results. Displays values for measurements

and calculations. Drag the measured results to the required location. 3 Patient banner. Customizable information for identifying

the patient, operator, institution, date, and time. 4 Imaging Parameters. Displays a list of imaging

parameter settings for each active mode. Displays a clip

icon when the clip store function is activated. 5 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. 6 Displays information about the network connection and

network job status. 7 Controls for printing and deleting thumbnails.

assigned to the trackball and the controls adjacent to the trackball.

For systems without a touch screen, this location

includes soft key selections available for the active mode or function. Soft key selections correspond to the controls and scroll wheel on the control panel directly above the trackball.

9 Image menu. Displays controls and functions of the

optional software programs available during review.

Use the trackball pointer to expand or collapse the

display of selections for each section in the menu.

For systems without a touch screen, this location

includes mode-specific optimization parameters and functions, measurement labels and tools, review selections, and access to exam types and transducers.

1 - 20 Instructions for Use

2 Safety and Care

Operating Safety and Environment ................................................................... 3

System Symbols ............................................................................................ 3

Labels .......................................................................................................... 11

Biohazard Considerations............................................................................ 13

Note on Fetal Examinations ................................................................. 14

Acoustic Output — Mechanical and Thermal Indices .................................. 15

Mechanical and Thermal Indices .......................................................... 16

Transmit Power Control ........................................................................ 16

Transmit Power Display........................................................................ 17

Imaging Functions that Change Acoustic Output ................................. 18

Transducer Surface Temperature Limits ..................................................... 19

Electrical Safety ........................................................................................... 20

Level of Protection Against Electrical Shock — System ....................... 21

Level of Protection Against Electrical Shock — Transducers ............... 21

Defibrillators ......................................................................................... 22

Defibrillator Use and the ACUSON AcuNav Ultrasound Catheter ........ 22

Implantable Devices ............................................................................. 22

Possible Combinations with Other Equipment ...................................... 23

Maintaining Data Integrity ............................................................................ 23

Data Compression ....................................................................................... 23

Caring for the Ultrasound System ................................................................... 24

Daily Checklist ............................................................................................. 24

Maintenance ................................................................................................ 25

Repair ................................................................................................... 25

Siemens Authorized Care..................................................................... 25

Caring for Documentation and Storage Devices .......................................... 26

Caring for the Battery Pack .......................................................................... 26

Recharging the Battery Pack ................................................................ 26

Battery Pack Replacement ................................................................... 26

Battery Pack Location .......................................................................... 27

Removing the Battery Pack .................................................................. 28

Installing a Battery Pack ....................................................................... 28

Recycling the Battery Pack ................................................................... 28

Cleaning and Disinfecting ............................................................................ 29

Cleaning Ultrasound System Surfaces ................................................. 29

Approved Disinfectant Wipes for the Ultrasound System Surfaces ...... 33

Cleaning the Air Filter ........................................................................... 34

Instructions for Use 2 - 1

2 Safety and Care

Caring for Transducers .................................................................................... 36

Methods for Cleaning and Disinfecting Transducers ................................... 38

Examples of Transducer Components ................................................. 39

Cleaning and Disinfecting Transducers ................................................ 42

Approved List of Cleaners .................................................................... 44

Approved List of Disinfectants .............................................................. 45

Sterilizing Transducers — 14L5 SP ............................................................. 46

Caring for Transducer Accessories ................................................................ 47

Transducer Sheaths .................................................................................... 47

Storage ................................................................................................. 47

Gel Pad........................................................................................................ 48

Storage ................................................................................................. 48

Needle Guide Bracket Kits........................................................................... 48

Storage and Transportation .................................................................. 48

Cleaning, Disinfecting, and Sterilizing Transducer Accessories .................. 49

Needle Guide Bracket Kits ................................................................... 49

Environmental Protection ................................................................................ 51

Product Recycling and Disposal .................................................................. 51

Hazardous Substances ........................................................................ 51

Caring for Batteries ...................................................................................... 51

Recycling Batteries ...................................................................................... 52

Disposing of the Packaging Materials .......................................................... 52

Disposing of Components and Accessories ................................................ 53

Energy Conservation ................................................................................... 53

2 - 2 Instructions for Use

2 Safety and Care

Symbol

Explanation

Operating Safety and Environment

Do not operate the ultrasound imaging system until you fully understand the safety considerations and procedures presented in this manual.

System Symbols

The table below is provided for your identification of important symbols located on the ultrasound imaging system and transducers:

Danger: Risk of explosion if used in the presence of flammable anesthetics.

Caution: Risk of electric shock.

Do not open. Refer servicing to qualified service personnel.

Consult instructions for use

It is mandatory you refer to the manual. (blue illustration)

Caution (black illustration)

Note: For systems and transducers shipped from the factory prior to 1 October 2010, the symbol means "Caution, consult accompanying documents."

General Warning (yellow and black illustration) Standby — ON

ON only for MAINS control

OFF only for MAINS control

Monitor Tint

Monitor Brightness

USB Connection

Ethernet Connection

Instructions for Use 2 - 3

2 Safety and Care

Symbol

Explanation

Control Panel Light or Indicator Light

Yellow Indicator Light

Status Indicator for DC Power Good (Green) or Green Indicator Light

Printer Connection

Type BF Defibrillator-proof Patient Connection

Type BF Applied Part

Type B Patient Connection

Continuous Wave Transducer Port

Transducer Port

ECG Signal Connection

Electrocardiogram (EKG) Signal Input

Signal Output

2 - 4 Instructions for Use

2 Safety and Care

Symbol

Explanation

Footswitch Connector

Equipotential Connection

Protective Earth Ground

Do not install wet

Location of Air Filter

Insert this way

Battery

Recycle Ni-MH battery

Do not dispose of by burning

The product must be properly disposed of in accordance with local, state, and regional laws and regulations.

Products bearing this symbol are subject to the European Community directive 2002/96/EC on waste electrical and electronic equipment (WEEE), amended by directive 2003/108/EC. For collection and disposal of the product, its components, or its accessories, contact your local Siemens representative.

Do not dispose of by flushing down lavatory

Instructions for Use 2 - 5

2 Safety and Care

Symbol

Explanation

Pinch hazard.

Do not lean against the monitor.

Shelf Weight Restriction

Brake Engaged

Brake Released

Direction/Steer Lock

Manufacturer's declaration of product compliance with applicable EEC directive(s) and the European notified body

DEMKO-Denmark approval mark

UL symbol for listing as recognized components for Canada and United States of America

UL classified symbol for Canada and United States of America

EAC (Eurasian Conformity mark) The Eurasian Conformity mark is a product marking to indicate

that the product conforms to all Technical Regulations of the Customs Union assessment procedures

Equipment complies with the standard and specifications published by IMDA (Info-communications Media Development Authority of Singapore)

"XXXXXX" represents the dealer's license number TÜV Rheinland INMETRO Certification Mark (Brazil)

Authorized representative in the European community

2 - 6 Instructions for Use

2 Safety and Care

Symbol

Explanation

Location of device manufacturing: United States of America

Location of device manufacturing: Republic of Korea

Location of device manufacturing: Japan

Location of device manufacturing: Netherlands

(System Installierte Volumen Komponente) Identifies the system for product traceability at Siemens

Healthcare (Installierte Volumen Komponente) Identifier of selected system components or parts for product

traceability Gost-R symbol indicates that this product is certified for

conformity to the safety requirements of Russian state standards

Caution: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician.

Safe working load "XXX" represents the weight of the system unpacked and ready

for operation with documentation devices installed Additional objects or devices on the system cannot exceed the

safe working load Transducer storage temperature range (example) System storage temperature range (example) Unlock (left) and lock (right) positions

Protected against the effects of temporary immersion in water Protected against the effects of continuous immersion in water Barcode

Barcode with product identification information according to the following barcode specification:

GS1 128 2D

Instructions for Use 2 - 7

2 Safety and Care

Symbol

Explanation

Global Trade Item Number Model revision

Serial number

Quantity of product

Siemens model number

Device part number Manufacturer country of origin: United States of America

Manufacturer country of origin: Republic of Korea

Manufacturer country of origin: Japan

Manufacturer country of origin: Netherlands

Date of Manufacture symbol with the date below

Manufacturer

2 - 8 Instructions for Use

2 Safety and Care

Symbol

Explanation

AC (alternating current) voltage source Identifies voltage, frequency, and current rating of system

configuration for MAINS. 100V~, 50/60 Hz, 15A maximum draw, 15A MAINS breaker.

Identifies voltage, frequency, and current rating of system configuration for MAINS.

115V~, 50/60 Hz, 12A maximum draw, 15A MAINS breaker.

Identifies voltage, frequency, and current rating of system configuration for MAINS.

230V~, 50/60 Hz, 6.5A maximum draw, 7.5A MAINS breaker.

Identifies voltage and circuit breaker current.

Instructions for Use 2 - 9

2 Safety and Care

Symbol

Explanation

Weight and size "XXX" represents the weight of the system packaged for

shipping "XX" represents the size of the box in inches

Do not stack

Recycle

Storage atmospheric pressure range (example)

Storage humidity range (example)

Indicates this side up

Do not stack

Shipping weight (example)

Do not allow to get wet

Fragile. Handle with care.

Refer to the operator's manual for information about compatible needle guides.

Environmentally friendly use period

Intentional transmitter of non-ionizing radiation.

2 - 10 Instructions for Use

2 Safety and Care

Labels

1 System warning label with certification

labels

Location of labels on the ultrasound system (example).

Instructions for Use 2 - 11

2 Safety and Care

1 Identification label 2 Country-specific labels 3 Country-specific labels

Example of system label.

Example of identification label.

1 Product name 2 System input power requirement

2 - 12 Instructions for Use

2 Safety and Care

Biohazard Considerations

WARNING: With the exception of systems licensed to use the ACUSON AcuNav catheter, this

equipment is not suitable for intracardiac use or direct cardiac contact.

See also: For additional information on the AcuNav catheter, refer to the user manual for the catheter.

WARNING: This equipment is not suitable for intracardiac use or direct cardiac contact.

WARNING: For neonatal head imaging, Siemens recommends that you exercise special care

during neonatal cephalic scanning to avoid possible damage to the posterior region of the eye. The ultrasound energy emitted by the transducer easily penetrates the fontanels of the infant.

WARNING: Siemens makes every effort to manufacture safe and effective transducers. You

must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, and during endocavity or intraoperative scanning; during biopsy or puncture procedures; or when scanning patients with open wounds.

WARNING: To eliminate the possibility of exposing patients, operators, or third parties to

hazardous or infectious materials, always dispose hazardous or infectious materials according to local, state, and regional laws and regulations.

WARNING: Transducer sheaths: There have been reports of severe allergic reactions to

medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.

WARNING: Ultrasound energy is transmitted more effectively through water than through tissue.

When using a standoff device of any kind, for example, a waterpath or gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the output display on the ultrasound system.

The assessment of the biological effects of diagnostic ultrasound on humans is a subject of ongoing scientific research. This ultrasound system, and all diagnostic ultrasound procedures, should be used for valid reasons, for the shortest possible period of time, and at the lowest mechanical and thermal indices necessary to produce clinically acceptable images.

According to the principles of ALARA (As Low As Reasonably Achievable), the acoustic output should be the lowest level required to satisfactorily perform the examination.

The ultrasound imaging system complies with the standards of the American Institute of Ultrasound in Medicine (AIUM) and the National Electrical Manufacturer's Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA) and the standards of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output levels. The ultrasound output levels are stated to permit the user to critically evaluate the ultrasound system settings in the event of new research findings being announced.

Instructions for Use 2 - 13

2 Safety and Care

Note on Fetal Examinations

The following recommendation is excerpted from the National Institute of Health in the United States of America. Consensus Statement on the Use of Ultrasound Imaging During Pregnancy, Volume 5, No. 1, based on the recommendation issued at the Health Consensus Development Conference, February, 1984:

Ultrasound examination in pregnancy should be performed for a specific medical indication. The data on clinical efficacy and safety do not allow a recommendation for routine scanning at this time.

Ultrasound examination performed solely to satisfy the family's desire to know the fetal sex, to view the fetus, or to obtain a picture of the fetus should be discouraged. In addition, visualization of the fetus solely for educational or commercial demonstrations without medical benefit should not be performed.

In August 1994, the Food and Drug Administration (FDA) notified the medical community and the ultrasound industry regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and to discourage patients from having sonograms for non-medical reasons.

The American Institute of Ultrasound in Medicine (AIUM) has also advocated the responsible use of diagnostic ultrasound for all fetal imaging (August 2005).

2 - 14 Instructions for Use

2 Safety and Care

Acoustic Output — Mechanical and Thermal Indices

WARNING: Ultrasound procedures should be used for valid reasons, for the shortest period of

time, and at the lowest mechanical/thermal index setting necessary to produce clinically acceptable images.

The ultrasound system incorporates an output display of Mechanical and Thermal Indices to allow you to monitor, and to limit, the amount of ultrasound energy that is transferred to the patient.

Example of the mechanical and thermal indices and the transmit power display on the image screen.

1 Mechanical and thermal indices 2 Transmit power display

Note: For ultrasound systems distributed in the United States of America, refer to the Medical Ultrasound Safety ultrasound education program brochure produced by the AIUM that is shipped with the system.

Instructions for Use 2 - 15

2 Safety and Care

Mechanical and Thermal Indices

The ultrasound system displays the Mechanical and Thermal Indices during real-time imaging, in all imaging modes, when the Mechanical Index or the Thermal Indices are equal to or exceed a value of 0.4.

Note: During exams using contrast agent imaging, the system always displays values for the Mechanical Index (MI) and the Maximum of Mechanical Indices measured at the active focal zones (MIF).

Indices display in the abbreviated form shown below:

 MI: Mechanical Index  MIF: Maximum of the Mechanical Indices measured at the active focal zones (displayed

during contrast agent imaging exams only)

 TIB: Bone Thermal Index (fetal application)  TIS: Soft Tissue Thermal Index  TIC: Cranial Thermal Index

Transmit Power Control

Adjust the transmit power and the corresponding acoustic pressure delivered through the transducer to the patient by using the designated control on the ultrasound system. It is the main system function that determines the transmitted intensity of ultrasound for all transducers and imaging modes during real-time imaging, though it is not the only function that affects the mechanical and thermal indices. The range and especially the maximum level of the mechanical and thermal indices differ depending on the transducers. In addition, each diagnostic exam type has preset values for mechanical and thermal indices.

Note: Maximum transmit acoustic intensity and the mechanical index for each exam type is limited in accordance with the United States Food and Drug Administration's (FDA) recommendations and guidelines. System default transmit intensity and mechanical index values are always below the FDA recommendations for each exam type. Although some exam types may default to a condition of maximum allowable transmit power, there are other system controls or functions that could raise acoustic output levels.

To increase the transmit power during real-time imaging:

● Rotate the [Transmit Power] control located below the touch screen clockwise to increase transmit power.

○ For systems without a touch screen, press the TX POWER control on the control panel

upward to increase transmit power.

To decrease the transmit power during real-time imaging:

● Rotate the [Transmit Power] control located below the touch screen counterclockwise to decrease transmit power.

○ For systems without a touch screen, press the TX POWER control on the control panel

downward to decrease transmit power.

2 - 16 Instructions for Use

2 Safety and Care

Adjusting the Transmit Power during Contrast Agent Imaging

During contrast agent imaging, you can also increase or decrease the transmit power. The transmit power range is from 0.10% to 100% for contrast agent imaging.

● Rotate the [Power] control located below the touch screen clockwise to increase transmit power. Rotate the [Power] control counterclockwise to decrease transmit power.

○ For systems without a touch screen, rotate the [Power] LED panel control clockwise to

increase transmit power. Rotate the [Power] control counterclockwise to decrease transmit power.

Transmit Power Display

The transmit power range is from 0% to 100%. Selecting 100%, in combination with other ultrasound system controls or functions, generates the maximum acoustic intensity and mechanical index for each transducer, where:

: ≤ 720 mW/cm2 and MI ≤ 1.9

SPTA.3

Instructions for Use 2 - 17

2 Safety and Care

Imaging Functions that Change Acoustic Output

WARNING: Observe the real-time display of mechanical and thermal indices (MI/TI) at all times.

In addition to the adjustment of the transmit power, adjustment of the following imaging functions and/or controls may affect the acoustic output:

 Automatic Time-out  Imaging Mode  Color Ensemble Size  Line Density/Resolution  Color ROI Position  M-mode ROI Position  Color ROI Size  Multi-Frequency  Doppler Gate Position  Doppler Color PRF  Presets  Doppler Gate Size  Reset  Exam Type  Transducer  Field of View (Scan Angle)  Transmit Power  Focus  Update  Frame Rate  Gel Pad  Freeze  Zoom  Image Depth

 Power On/Off

2 - 18 Instructions for Use

2 Safety and Care

Transducer

TMM

Still Air

38.6°C

35.9°C

40.7°C

40.5°C

41.4°C

41.0°C

36.0°C

36.7°C

41.1°C

Transducer Surface Temperature Limits

The following table provides the maximum surface temperature of the transducers compatible with the system.

Maximum surface temperatures are in accordance with IEC 60601-2-37.

Maximum Temperature

4C1 6C1 HD 6C2 8C3 HD 9L4 12L4 14L5 14L5 SP 18L6 HD 4P1 4V1 4V1c 8V3 10V4 V5Ms V7M EV-8C4 EC9-4 MC9-4 7CF1 7CF2 9EVF4 CW2 CW5 AcuNav 8F AcuNav 10F

TMM = Tissue Mimicking Material NA = not applicable (not tested)

≤ ≤ 41.0°C ≤ 38.0°C ≤ 40.1°C ≤ 40.0°C ≤ 41.0°C ≤ 42.5°C ≤ 39.4°C ≤ 38.1°C ≤ 42.5°C ≤ 47.0°C ≤ 41.7°C ≤ 41.1°C ≤ ≤ 42.9°C ≤ 43.0°C ≤ 40.9°C ≤ 42.6°C ≤ 40.3°C ≤ 40.8°C ≤ 42.3°C ≤ 46.0°C ≤ ≤ 37.7°C ≤ 36.5°C ≤ 36.4°C ≤ 39.4°C ≤ 42.6°C ≤ 40.3°C ≤ 38.9°C ≤ 39.6°C ≤ ≤ 42.5°C ≤ 45.3°C ≤ 38.6°C ≤ 45.0°C ≤ 36.7°C ≤ 37.2°C ≤ 38.4°C ≤ 38.3°C ≤ 36.9°C ≤ 37.7°C ≤ 35.3°C ≤ 37.7°C ≤ ≤ 39.6°C

≤

NA NA

Instructions for Use 2 - 19

2 Safety and Care

Electrical Safety

WARNING: To avoid electric shock, use a protective earth connection to connect the ultrasound

system to the mains power supply. The protective earth connection ensures that the mains circuit breaker will disconnect the power supply in the event of a short circuit.

WARNING: For 115V ultrasound systems: To ensure grounding reliability, only connect the

system to a hospital-grade power outlet.

WARNING: The AC power connector plug for the ultrasound system is a three-prong grounded

plug (in the U.S.A.) and should never be adapted to any two-prong (non-grounded) outlet, either by modifying the plug or by using an adapter. In the U.S.A., proper grounding requires the AC power connector plug to be plugged into a hospital-grade power outlet.

WARNING: To avoid electrical shock, never modify the ultrasound system AC power connector

plug, as doing so may overload your facility's power circuits. To ensure grounding reliability, connect the system only to an equivalent outlet.

WARNING: To avoid electrical shock, never use equipment or a mains power cord that shows

signs of wear or tampering, or that has a ground plug which has been bypassed by using an adapter.

WARNING: Equipment connected to the ultrasound system and in the patient zone must be

powered from a medically-isolated power source or must be a medically-isolated device. Equipment powered from a non-isolated source can result in chassis leakage currents exceeding safe levels. Chassis leakage current created by an accessory or device connected to a non-isolated outlet may add to the chassis leakage current of the ultrasound system.

WARNING: Using an extension cord or multi-socket outlet setup to provide power to the

ultrasound system, or to the system's peripheral devices may compromise the system grounding and cause your system to exceed leakage current limits.

WARNING: To avoid electrical shock and damage to the ultrasound system, power off and

unplug the equipment from the AC power outlet before cleaning and disinfecting.

WARNING: To avoid electrical shock and damage to the control panel resulting from ingress of

liquid, place the gel bottle and gel warmer on the side of the system closest to the patient.

WARNING: To prevent excessive leakage current from contacting the patient, do not touch a

user-accessible connector on the system while touching or scanning the patient. Useraccessible connectors include the ECG connector, a USB connector, and any other audio, video, or data transmission connectors.

WARNING: Connecting peripheral devices to accessory outlets on the ultrasound system

effectively creates a medical electrical system, resulting in a reduced level of safety.

WARNING: Do not modify this equipment without authorization from Siemens.

2 - 20 Instructions for Use

2 Safety and Care

Caution: To avoid the possibility of static shock and damage to the system, avoid the use of

aerosol spray cleaners on the monitor screens.

Caution: Do not use spray cleaners on the ultrasound system, as this may force cleaning fluid

into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components.

Caution: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the

electrical circuitry may cause excessive leakage current or system failure.

Caution: To ensure proper grounding and leakage current levels, it is the policy of Siemens to

have an authorized Siemens representative or Siemens approved third party perform all on-board connections of documentation and storage devices to the ultrasound system.

Caution: To maintain the safety and functionality of the ultrasound system, maintenance must

be performed every 24 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed.

EMC Note: Proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations may lead to interference visible on the monitor screen. However, the device has been designed and tested to withstand such interference and will not be permanently damaged.

Level of Protection Against Electrical Shock — System

According to EN 60601-1 and IEC 60601-1, the system provides a "Level of Protection Against Electrical Shock" of "Type B."

The Type B icon is located on the system.

Level of Protection Against Electrical Shock — Transducers

According to EN 60601-1 and IEC 60601-1, the assemblies for the endocavity transducer and the linear, curved, and phased array transducers provide a "Level of Protection Against Electrical Shock" of "Type BF."

The Type BF icon is located on the transducer label.

Example of a transducer label.

Instructions for Use 2 - 21

2 Safety and Care

Defibrillators

WARNING: The ECG function is designed to withstand the effects of defibrillation. However,

when possible, disconnect the ECG leads during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient.

For patient safety, be sure to use defibrillators that do not have grounded patient circuits.

Defibrillator Use and the ACUSON AcuNav Ultrasound Catheter

WARNING: The catheter is designed to withstand the effects of defibrillation. However, when

possible, disconnect the connector from the ultrasound system during defibrillation because a malfunction of the safety controls could otherwise result in electrical burns for the patient.

The catheter is designed to withstand the effects of defibrillation. There are no exposed conductive surfaces distal to the handle. Within the flexible shaft, a chassis ground shield covers all active circuits and conductors.

Recovery Time After Defibrillation During a Catheter Procedure

If you disconnect the SwiftLink catheter connector from the ultrasound system before defibrillation, the recovery time after defibrillation is equal to the time required to reconnect the connector to the ultrasound system.

The recovery time after defibrillation for the ultrasound system:  Three (3) minutes if defibrillation is performed with the ultrasound system on.

Implantable Devices

WARNING: Ultrasound systems, like other medical equipment, use high-frequency electrical

signals that can interfere with implantable devices such as pacemakers and implantable cardioverter-defibrillators (ICDs). If the patient has such an implantable device, you should be aware of any interference in its operation and immediately power off the ultrasound system.

2 - 22 Instructions for Use

2 Safety and Care

Possible Combinations with Other Equipment

WARNING: Accessory equipment connected to the analog and digital interfaces must be

certified according to the respective EN and IEC standards (for example, EN 60950 and IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Anyone who connects additional equipment to any of the signal input or signal output ports configures a medical system and is therefore responsible that the system complies with the requirements of the system standards IEC 60601-1. Siemens can only guarantee the performance and safety of the devices listed in the Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

The ultrasound system supports a maximum of three documentation devices connected to the system. Depending on how your system is configured, certain documentation devices will maintain power when the system is powered off. Although this will not cause harm to your documentation device, Siemens recommends that you power off each device whenever the system is powered off.

Some on-board peripheral devices must be installed by an authorized Siemens representative or by a Siemens-approved third party. Devices installed by other people will be at the user's risk and may void the system warranty.

Maintaining Data Integrity

Important Information

To ensure data integrity:

 To prevent the loss of data that results from power failures and other system "down"

occurrences, you must archive important data, such as patient records, onto an external recording media, such as a CD or a network.

 Loss of data is to be expected and its retrieval is not normally possible under the following

conditions: loss of power to the ultrasound system, hard disk failure, CPU failure, system lockup, and other similar causes.

 Should an abnormal system shutdown occur, retrieval of data not saved to the hard disk or

not archived to an external recording media is not normally possible. An abnormal system shutdown occurs if you do not power off the ultrasound system using

the green partial power on/off switch ( ) located on the front of the system. Other examples of abnormal system shutdown include: equipment malfunction, loss of power, or pressing and holding the green partial power on/off switch longer than 4 seconds.

 Should an abnormal system shutdown occur, the system may initially require additional

time to reboot or to respond to user input. This is due to the operating system performing a background scan of the hard disk to detect and segregate any truncated or corrupted files.

Data Compression

WARNING: This product uses JPEG Lossy compression that is irreversible and can result in the

loss of image quality. All compressed images contain information about the compression ratio and compression type. This product conforms to the DICOM standard. DICOM conformance statements for ultrasound products are available at www.siemens.com/dicom.

Instructions for Use 2 - 23

2 Safety and Care

Caring for the Ultrasound System

It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic operation on a daily basis. Each day, prior to using the system, perform each of the steps in the Daily Checklist.

All exterior parts of the ultrasound system, including the control panel, keyboard, transducers, and biopsy devices, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to destroy pathogens and other microorganisms.

The ultrasound system has removable, washable air filters. The filters must be cleaned regularly to maintain proper system cooling. Check the air filters weekly, and clean as needed.

Daily Checklist

WARNING: To minimize the risk of cross-contamination and infectious diseases, a sterile,

non-pyrogenic transducer sheath must be in place during procedures requiring sterility.

WARNING: To avoid electrical shock, you must visually inspect a transducer prior to use. Do not

use a transducer that has a cracked, punctured, or discolored casing or a frayed cable.

Discoloration Exception: The use of approved cleaners and disinfectants may cause discoloration of the transducer. You can continue to use a transducer discolored due to the use of approved cleaners and disinfectants only.

Perform the following each day before using the ultrasound system:

 Visually inspect all transducers. Do not use a transducer that has a cracked, punctured, or

discolored casing or a frayed cable.

 Visually inspect all power cords. Do not power on the ultrasound system if a cord is frayed

or split, or shows signs of wear.

 Visually inspect the ECG connector and the cable. Do not use the ECG function if the

connector or cable is damaged or broken.

 Verify that the trackball, DGC slide controls, and other controls on the control panel appear

clean and free from gel or other contaminants.

Once the ultrasound system is powered on:

 Visually check the on-screen displays and lighting.  Verify that the monitor displays the current date and time.  Verify that the transducer identification and indicated frequency are correct for the active

transducer.

2 - 24 Instructions for Use

2 Safety and Care

Maintenance

Caution: To maintain the safety and functionality of the ultrasound system, maintenance must

be performed every 24 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed.

Repair

For questions regarding repair or replacement of any equipment parts on your system, contact your Siemens service representative.

Siemens Authorized Care

Installers and operators must observe any statutory regulations that govern the installation, operation, inspection, and maintenance of this equipment.

To ensure the safety of patients, operators, and third parties, the equipment must be inspected every 24 months, and the replacement of parts is performed as necessary. This maintenance must be performed by a qualified Siemens authorized representative. It is important to inspect the equipment more frequently if it is operated under extraordinary conditions.

Perform inspections and maintenance at the prescribed intervals to avoid worn and hazardous parts due to wear. Contact the Siemens service department for information regarding the required maintenance.

As manufacturers and installers of ultrasound equipment, Siemens cannot assume responsibility for the safety properties, reliability, and/or performance of the equipment, if:

 Installations, extensions, readjustments, modifications, additions, or repairs are carried out

by persons not specifically authorized by Siemens.

 Components that affect the safe operation of the system are replaced by parts not

authorized by Siemens.

 The electrical installation of the room where the equipment is located does not meet the

power and environmental requirements stated in this manual.

 The equipment is not used in accordance with the operating instructions.  The system is operated by personnel not adequately educated or trained.

Siemens suggests that you request any person who performs maintenance or repairs to provide you with a certificate showing:

 The nature and extent of the work performed  Changes in rated performance  Changes in working ranges  Date of service  Name of person or firm performing the service  Signature of person performing the service

Technical documentation pertinent to the ultrasound system is available at an additional charge. However, this does not in any way constitute an authorization to conduct repairs or maintenance. Siemens refuses all responsibility whatsoever for repairs that are performed without the express written consent of the Siemens service department.

Instructions for Use 2 - 25

2 Safety and Care

AC Tray Panel

Typical Time to Recharge

Maximum Time to Recharge

Caring for Documentation and Storage Devices

For information on the care of an optional documentation or storage device, refer to the manufacturer's operating instructions that accompanied the device.

Caring for the Battery Pack

Recharging the Battery Pack

See also: Recycling Batteries, p. 2-52

2 - 28 Instructions for Use

2 Safety and Care

Cleaning and Disinfecting

You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. Use universal precautions when cleaning and disinfecting. You should treat all portions of the ultrasound system that come in contact with human blood or other body fluids as if they were known to be infectious.

Cleaning Ultrasound System Surfaces

WARNING: To avoid electric shock and damage to the ultrasound system, power off and unplug

the equipment from the AC power outlet before cleaning and disinfecting.

WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for

compatibility with product materials, not for biological effectiveness. Refer to disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses.

WARNING: The use of any disinfectants other than those specified in the instructions for use

may damage the ultrasound system and accessory surfaces and, as a result, may create electrical hazards for the patients and/or users.

Caution: To avoid the possibility of static shock and damage to the ultrasound system, avoid the

use of aerosol spray cleaners on the monitor screens.

Caution: Do not clean the ultrasound system with chlorinated or aromatic solvents, acidic or

basic solutions, isopropyl alcohol or strong cleaners such as ammoniated products, as these can damage the surface of the system. Use the recommended cleaning procedure.

Caution: Do not use spray cleaners on the ultrasound system, as this may force cleaning fluid

into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components.

Caution: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the

electrical circuitry may cause excessive leakage current or system failure.

Caution: Prior to cleaning or disinfecting the system, you must disconnect and remove

transducers from the ultrasound system. Unintended contact with disinfectants approved only for use with the system can result in damage to the transducers.

Instructions for Use 2 - 29

2 Safety and Care

The following instructions describe cleaning the surface of the ultrasound system, including the trackball and transducer holder.

To Do This

Clean and disinfect the surface of the ultrasound system

1. Power off the ultrasound system and unplug the power cord from the power outlet.

2. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to wipe the surface of the ultrasound system.

If your system has a touch screen, take care to gently wipe the surface of the touch screen.

Take particular care to clean the areas near the trackball and the slide controls. Ensure these areas are free of coupling agent (gel) and any other visible residue.

Ensure that cleaning solution does not seep into the control panel, keyboard, or any other openings.

3. After cleaning, use a clean, lint-free cloth to dry the surface.

4. As required, use an approved disinfectant wipe to disinfect the ultrasound system and accessories.

5. Reconnect the ultrasound system power cord into the power outlet.

Clean and disinfect the holders for transducers and coupling gel

1. Remove the holder from the ultrasound system. a. Reach under the holder to locate the tab on the holder. The tab extends below

the point of attachment to the ultrasound system.

b. Squeeze the tab towards the holder and pull the holder downward.

2. Clean the holder under running water, using a mild detergent and dry with a lint-free cloth.

3. As required, use an approved disinfectant wipe to disinfect the holder.

4. Reattach the holder to the ultrasound system. Align the support on the holder directly below the point of attachment on the

ultrasound system and firmly push upwards until the holder snaps into place.

2 - 30 Instructions for Use

2 Safety and Care

Do This

Clean and disinfect the gel warmer

Caution: To avoid damage to the gel warmer, do not immerse the gel warmer in

water or any solution.

Note: To facilitate cleaning, remove the cap at the bottom of the gel warmer. Rotate the cap counterclockwise to remove the cap; rotate the cap clockwise to secure the cap.

1. Remove the gel warmer from the ultrasound system. a. Unplug the power cable attached to the gel warmer from the ultrasound system.

The connector on the ultrasound system is located on the right or left side of the control panel, just behind the point of attachment for the gel warmer.

b. Reach under the gel warmer to locate the tab on the gel warmer. The tab

extends below the point of attachment to the ultrasound system.

c. Squeeze the tab towards the gel warmer and pull the gel warmer downward.

2. Unplug the power cable from the gel warmer.

3. Clean and disinfect the gel warmer using an approved disinfectant wipe.

4. Reattach the gel warmer to the ultrasound system. a. Attach one end of the power cable accompanying the gel warmer to the

connector on the back of the gel warmer and then attach the other end of the power cable to the connector on the ultrasound system.

b. Align the support on the gel warmer directly below the point of attachment on the

ultrasound system and firmly push upwards until the gel warmer snaps into place.

Instructions for Use 2 - 31

2 Safety and Care

Do This

Example of the trackball ring.

Example trackball assembly.

Clean and disinfect the trackball

Caution: Do not drop or place foreign objects inside the trackball assembly

because doing so may affect the trackball operation and damage the ultrasound system.

1 Tab for inserting into the trackball

assembly

2 Raised markings on either side of the

ring

1 Point of attachment for the trackball

ring

1. Rotate the ring around the trackball counterclockwise and then carefully lift up the ring to remove the ring and trackball.

2. Clean the ring and trackball with a cotton swab or lint-free pad moistened with mild detergent solution.

3. Clean the inside of the trackball assembly with a cotton swab or lint-free pad moistened with mild detergent solution.

4. As required, use an approved disinfectant wipe to disinfect the ring, trackball, and trackball assembly.

5. Allow the trackball components to completely dry before reassembly.

6. Reinstall the ring and trackball. a. Place the trackball inside the trackball assembly. b. Place the ring over the trackball, taking care to align the tab with the point of

attachment on the trackball assembly.

c. Rotate the ring clockwise until the ring snaps into place and the ridges of the ring

are in a horizontal position.

2 - 32 Instructions for Use

2 Safety and Care

Sani-Cloth

Bleach Wipe*

Sani-Cloth HB

Plus

Sani-Cloth

   

Trackball Assembly

Gel Warmer

Approved Disinfectant Wipes for the Ultrasound System Surfaces

The following matrix provides a list of approved disinfectant wipes for use on the ultrasound system and surfaces of the listed accessories.

Ultrasound System

Transducer Holders

*or any bleach wipe with <1% sodium hypochlorite and no other active ingredients  = approved NA = not approved

               

Sani-Cloth

Super

Instructions for Use 2 - 33

2 Safety and Care

Cleaning the Air Filter

The filter location is marked with the air filter symbol.

The ultrasound system has one removable, washable air filter. This air filter must be cleaned regularly to maintain proper system cooling. Check the air filter weekly, and clean as needed. Clean and reinstall the air filter according to the following instructions.

1 Location of back panel air filter

Example of the location of the air filter.

2 - 34 Instructions for Use

2 Safety and Care

To remove and clean the back panel air filter:

Caution: Do not scrub, stretch, or bend the filter, or apply heat to the filter, as doing so could

damage the filter.

1. Power off and unplug the power cord from the power outlet.

2. Locate the air filter tray in the back panel and pull the tray out of the ultrasound system.

3. Remove the air filter from the tray.

4. Rinse the air filter with running water and allow the filter to completely dry. To hasten drying, you may gently shake the filter, or blot the filter with a clean, lint-free

cloth.

Caution: Do not insert a wet filter as this can damage the system.

5. Replace the air filter into the tray, positioning the filter flat side down, with the angled corners fitting into the back of the tray. The filter will fit into the back corners of the tray only if the filter is positioned flat side down.

6. Press the filter against the hook and loop fasteners on the tray.

7. Slide the air filter tray back into the ultrasound system.

8. Plug the power cord into the power outlet.

Instructions for Use 2 - 35

2 Safety and Care

Caring for Transducers

WARNING: To minimize the risk of cross-contamination and infectious diseases, clean and

high-level disinfect endocavity transducers after each use; clean and sterilize intraoperative transducers after each use.

WARNING: During neurosurgical procedures, if a transducer becomes contaminated with tissue

or fluids of a patient known to have Creutzfeldt-Jacob disease, the transducer should be destroyed as it cannot be sterilized.

WARNING: When using an endocavity or intraoperative transducer with a BF or CF type applied

part, the patient leakage currents may be additive.

WARNING: Prior to each use, inspect the endocavity or intraoperative transducer for signs of

mechanical damage such as cracks, cuts, tears, perforations, or protrusions. Do not use the transducer if the transducer appears damaged in any way. Any damage could cut the patient and compromise the electrical safety of the transducer, causing possible patient or user injury. Contact your local Siemens representative.

Caution: Transducers are sensitive instruments — irreparable damage may occur if they are

dropped, knocked against other objects, cut, or punctured. Do not attempt to repair or alter any part of a transducer, contact your local Siemens representative.

Caution: To avoid cable damage, do not roll the ultrasound system over transducer cables.

Caution: To avoid damage to the transducer, do not use transducer sheaths containing an

oil-based coating or petroleum- or mineral oil-based ultrasound coupling agents. Use only a water-based ultrasound coupling agent.

Caution: Follow all instructions provided by manufacturers of sterile goods (transducer sheaths)

to ensure proper handling, storage, and cycling of all sterile goods.

Take extreme care when handling or storing transducers. They must not be dropped, jarred, or knocked against other objects. Do not allow transducers to come into contact with any sharp-edged or pointed object.

2 - 36 Instructions for Use

2 Safety and Care

Protective Case

Due to the mechanical sensitivity of transducers, Siemens recommends that you always use the transducer case when you ship a transducer or transport it from one place of examination to another. The case is specially designed to protect the sensitive parts of the transducer. Be sure that all parts of the transducer are properly placed inside the case before you close the lid.

Storage

Store transducers in a clean and dry environment. Extreme temperatures or humidity may damage a transducer.

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

Repair

Do not attempt to repair or alter any part of the transducer. Contact your service representative at Siemens immediately if a transducer appears to be damaged or malfunctions in any way.

Instructions for Use 2 - 37

2 Safety and Care

Example of Transducers

Use

Required Method

Classification

Laparoscopic

Methods for Cleaning and Disinfecting Transducers

You must observe the required methods for cleaning and disinfecting or cleaning and sterilization before the first use and after each use of a transducer.

Siemens defines the methods for cleaning and disinfecting or cleaning and sterilization by classifying the use of the transducer according to the Spaulding Classification scheme observed by the United States Food and Drug Administration (FDA).

 Intraoperative

  Endocavity  Transesophageal  Non-invasive Non-intact skin

 Non-invasive Intact skin

Sterile body tissue Cleaning and sterilization Critical

Intact mucous membranes

Cleaning and high-level disinfection

Cleaning and low-level disinfection

Semi-critical

Noncritical

Important Information

The ACUSON S1000, ACUSON S2000, and ACUSON S3000 ultrasound systems do not support the following transducers:

 Laparoscopic

See also: For information on cleaning and disinfecting transesophageal transducers, refer to Chapter 6 in this manual.

2 - 38 Instructions for Use

2 Safety and Care

1 Transducer surface in contact with

Examples of Transducer Components

1 Transducer surface in contact with

the patient 2 Handle 3 Strain relief for the transducer 4 Cable 5 Strain relief for the connector 6 Connector 7 Electrical component on the

connector

Example of transducer components.

Example of endocavity transducer components.

the patient 2 Handle 3 Strain relief for the transducer 4 Cable 5 Strain relief for the connector 6 Connector 7 Electrical component on the

connector

Instructions for Use 2 - 39

2 Safety and Care

1 Transducer surface in contact with

the patient (flexible shaft with depth

markings, articulating section, and

distal tip) 2 Strain relief for the handle 3 Cable 4 Strain relief for the connector 5 Electrical component on the

connector 6 Connector 7 Handle with controls 8 Strain relief for the handle

Example of transesophageal transducer components.

2 - 40 Instructions for Use

2 Safety and Care

Immersion Levels

Caution: To avoid damage to the transducer, observe the immersion levels indicated for each

transducer type.

Caution: Do not immerse the label located on the cable of the CW transducer.

Note: Transducers meet Ingress Protection level IPX8 of EN 60529 and IEC 60529 to the depth of the immersion line shown in the illustration. Endocavity transducers exceed minimum Ingress Protection level IPX7 of IEC 60601-2-18 to the depth of the immersion line shown in the illustration.

Note: Intraoperative transducers are immersible up to the strain relief on the connector.

Example of immersion levels.

1 Endocavity 2 Linear 3 Curved 4 Phased 5 fourSight 4D 6 fourSight 4D (endocavity) 7 Continuous Wave (CW)

Instructions for Use 2 - 41

2 Safety and Care

Cleaning and Disinfecting Transducers

WARNING: To avoid electrical shock and damage to the system, disconnect the transducer

prior to cleaning or disinfecting.

WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for

compatibility with product materials, not for biological effectiveness. Refer to disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses.

Caution: Do not sterilize transducers using hot steam, cold gas, or Ethylene Oxide (EO)

methods. Before applying any other methods that might be recommended by manufacturers of sterilization equipment, please contact your Siemens representative.

Caution: To avoid damage to the transducer, observe the immersion levels indicated for each

transducer type. Do not immerse or allow the connector of a transducer or the strain relief on the connector to become wet.

Caution: The transducers have been designed and tested to be able to withstand disinfection as

recommended by the manufacturer of the disinfectant product. Carefully follow the disinfectant manufacturer's instructions. Do not immerse for more than one hour.

Caution: Do not use abrasive cleaners, organic solvents such as benzene, isopropyl alcohol, or

phenol-based substances, cleaners, or disinfectants containing organic solvents to clean or disinfect transducers. These substances can damage the transducers.

Caution: Do not use an abrasive sponge or brush. These materials can damage the transducer.

Caution: The use of a spray cleaner or disinfectant may force fluid inside the transducer and the

ultrasound system. To avoid damage, first remove the transducer from the system and then carefully spray the transducer. Never spray the transducer connector.

Caution: Prior to cleaning or disinfecting a transducer, you must disconnect and remove the

transducer from the ultrasound system. Do not clean or disinfect the transducer on or near the ultrasound system. Unintended contact with approved transducer cleaners and disinfectants can result in severe damage to the ultrasound system components.

2 - 42 Instructions for Use

2 Safety and Care

Read and understand the biohazard considerations.

p. 2-13

Clean and disinfect the transducer after each use.*

p. 2-43

Location in This

Required Task

Manual

Perform the steps in the daily checklist. p. 2-24 Read and understand the cleaning and disinfecting information for the ultrasound system. p. 2-24 Read and understand all transducer-specific warnings and cautions. p. 2-36 Disconnect the transducer. Chapter 3

Select an approved disinfectant. p. 2-45 Dry and store the transducer in its protective carrying case. p. 2-37

*Information on cleaning and disinfecting transesophageal transducers is located in Chapter 6 in this manual.

To clean and disinfect a transducer:

1. Wipe visible gel or particles from the transducer with a soft cloth.

2. Remove any transducer accessories from the transducer.

3. Disconnect and remove the transducer from the ultrasound system.

4. To remove existing particles from the transducer prior to disinfection, moisten a clean gauze pad or cloth with water or an approved cleaner and then wipe the transducer. Avoid touching the electrical components on the connector.

See also: For a list of approved cleaners, refer to p. 2-44.

5. Select an approved disinfectant for low-level or high-level disinfection. Follow the disinfectant manufacturer's instructions for the required level of disinfection.

See also: For a list of approved disinfectants, refer to p. 2-45.

a. Moisten a clean gauze pad with the disinfectant, if necessary. b. Carefully wipe the transducer from the connector to the surface which was in contact

with the patient. Avoid touching the electrical components on the connector.

Note: If immersion is required, keep the transducer connector and connector strain relief dry while immersing the transducer in an approved disinfectant to the immersion level indicated on p. 2-41.

6. Follow the disinfectant manufacturer's instructions for drying the transducer.

Note: If the disinfectant manufacturer does not provide drying instructions, dry the transducer with a clean, lint-free, soft cloth.

Instructions for Use 2 - 43

2 Safety and Care

ENZOL

Gigasept FF

Transeptic

4C1

 

6C2

7CF1

7CF2

EC9-4

MC9-4

 

12L4

14L5

14L5 SP

4V1

4V1c

 

V5Ms

V7M

CW2

 

Approved List of Cleaners

Note: Gigasept FF may discolor the transducer. There is no associated degradation of imaging

performance or transducer reliability. You can use Gigasept FF as a cleaner and a disinfectant.



6C1 HD

8C3 HD

EV-8C4

9EVF4

9L4

18L6 HD 4P1 NA

8V3

10V4

CW5

 = approved NA = not approved

                     

 

 NA NA

 

      

         

   



NA NA NA NA

2 - 44 Instructions for Use

2 Safety and Care

4C1

6C2

7CF1

7CF2

     



EC9-4

MC9-4

9EVF4

      



14L5

14L5 SP

4V1

4V1c

         

V5Ms

V7M

CW2

Approved List of Disinfectants

Note: CIDEX OPA and Gigasept FF may discolor the transducer. There is no associated degradation

of imaging performance or transducer reliability. You can use Gigasept FF as a cleaner and a disinfectant.

6C1 HD

8C3 HD

EV-8C4

9L4

12L4

18L6 HD

4P1

8V3

10V4

CW5

 = approved NA = not approved

CIDEX

                                            

                       

                                                        

                                  

CIDEXPLUS

CIDEX OPA

Gigasept FF

NA NA NA NA

Milton

PI-Spray II

   

Rely+On Virkon

Revital Ox

NA NA

NA NA NA NA

NA NA NA NA NA NA NA NA

RESERT HLD

Sani-Cloth AF3

 



NA NA NA

   NA NA

   NA NA NA

  

 

  

Sani-Cloth HB

   

 



 

   

Super

Sani-Cloth

Instructions for Use 2 - 45

2 Safety and Care

Sterilizing Transducers — 14L5 SP

Caution: The transducers have been designed and tested to be able to withstand sterilization as

recommended by the manufacturer of the sterilization system. Carefully follow the sterilization manufacturer's instructions.

The STERRAD® sterilization system, a hydrogen peroxide gas plasma sterilization system, is approved for use with the listed intraoperative transducer(s).

 14L5 SP

To sterilize a transducer with the STERRAD system:

Note: This procedure applies to the 14L5 SP transducer only.

1. Disconnect the transducer from the system.

2. Thoroughly clean, rinse, and dry the transducer.

3. Carefully follow the manufacturer's instructions for sterilization.

2 - 46 Instructions for Use

2 Safety and Care

Caring for Transducer Accessories

Instructions are provided for the following accessories for transducers:

 Transducer Sheaths  Gel Pads  Needle Guide Bracket Kits

See also: Transducer Accessories and Biopsy, Chapter 5, Instructions for Use

Transducer Sheaths

WARNING: There have been reports of severe allergic reactions to medical devices containing

latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.

WARNING: To minimize the risk of cross-contamination and infectious diseases, a sterile,

non-pyrogenic transducer sheath must be in place during procedures requiring sterility.

WARNING: Only a sterile transducer sheath provides the sterile barrier required for surgical

procedures. To ensure sterility of a procedure, always place a sterile sheath on a transducer, as transducers cannot be sterilized using hot steam, cold gas, or Ethylene Oxide (EO) methods.

Caution: Siemens recommends that you follow all instructions provided by manufacturers of

sterile goods (transducer sheaths) to ensure proper handling, storage, and cycling of all sterile goods.

Using a disposable latex transducer sheath on a transducer reduces the possibility of cross-contamination. Always use a protective transducer sheath for endocavity exams, and when scanning an open wound or an area where the skin is not intact.

Storage

WARNING: Before use, examine sterile goods, such as sheaths, for any material flaws. Some

packaging may list an expiration date. Any product showing flaws, or whose expiration date has passed, should not be used.

Caution: Do not store transducer sheaths in direct sunlight, as ultraviolet damage can result.

Latex products have a limited shelf life, and should be stored in a cool, dry, dark place with an ambient temperature between -5°C and +40°C and up to 80% relative humidity at +40°C. Before use, examine these products for any material flaws. Some packaging may list an expiration date. Any product showing flaws, or whose expiration date has passed, should not be used.

Instructions for Use 2 - 47

2 Safety and Care

Gel Pad

Before use, examine the gel pad for any material flaws. Thinning, bulging, or brittleness of the material indicates damage. Any product showing flaws should not be used.

Storage

Do not store the gel pads below 40°F (5°C) nor above 135°F (57°C). Gel pads have a limited shelf life. Before use, examine these products for any material flaws. Some packaging may list an expiration date. Any product showing flaws, or whose expiration date has passed, should not be used.

Needle Guide Bracket Kits

WARNING: If a needle guide becomes contaminated with tissue or fluids of a patient known to

have Creutzfeldt-Jacob disease, then the needle guide should be destroyed. Sterilization is not effective against Creutzfeldt-Jacob contamination.

Needle guide bracket kits are available for biopsy and puncture procedures for specific transducers.

Storage and Transportation

Always clean and sterilize or high-level disinfect components used in a needle puncture or biopsy procedure after each use.

Refer to the in-box instructions for storage and transportation information for all needle guide accessories except as noted below.

Storing or Transporting the EC-1 Bracket Kit

 Do not use the carrying case for storing the bracket assembly. If the carrying case is used

for storage, it may become a source of infection.

 The bracket assembly must be stored and transported under the following environmental

conditions:

– Ambient temperature: -10°C to 60°C – Relative humidity: 30% to 95% (no condensation) – Atmospheric pressure: 700 hPa to 1060 hPa

 Between examinations, keep the bracket assembly in a sterile environment.  When the biopsy adapter is transported to a different hospital or clinic or is sent to your

Siemens representative for repair, be sure to sterilize it and keep it in the carrying case for transportation to prevent infection.

2 - 48 Instructions for Use

2 Safety and Care

Method

Concentration

Procedure

Temperature

Humidity

Pressure

Time

(1.0 kgf/cm2)

Cleaning, Disinfecting, and Sterilizing Transducer Accessories

WARNING: Ensure the accessories for a transducer are properly cleaned, sterilized, or

disinfected as appropriate before each use to avoid possible patient contamination.

Needle Guide Bracket Kits

Needle guide bracket kits are available for specific transducers. Instructions follow for the cleaning, disinfecting, and sterilization of each kit. Bracket assemblies should be cleaned and sterilized or high-level disinfected after each use.

See also: For a list of transducers compatible with the needle guide accessories, refer to Chapter 5 in this manual.

EC-1 Needle Guide Bracket Kit for Endocavity Transducers

WARNING: The EC-1 Needle Guide Bracket kit is packaged non-sterile. Sterilize this product

prior to its first use.

Prior to sterilization, clean the bracket assembly.

To clean the bracket assembly:

1. Rinse the bracket under water and remove all debris. Avoid using a brush as it may damage the needle guide bracket.

2. Visually inspect the guide to make sure all debris is removed.

3. Wipe off water on the bracket assembly using a sterile cloth or sterile gauze.

To sterilize the bracket assembly:

Use sterile technique to perform this procedure.

1. Sterilize assembly using high-pressure steam sterilization (130°C [266°F] for an exposure time of 10 minutes), EO (ethylene oxide) sterilization, or hydrogen peroxide plasma sterilization.

2. Perform one of the gas sterilization methods listed below:

Sterilization

Gas

Ethylene Oxide Gas 10% 50°C (122°F) 50%

Hydrogen Peroxide Plasma

STERRAD

For details, refer to the operation manual for the STERRAD® sterilization system.

Maximum operating pressure 980 hPa

3. After gas sterilization, thoroughly degas (aerate) the biopsy adapter to remove all gas residues.

7 hours

Instructions for Use 2 - 49

2 Safety and Care

CH4-1, C7F2/C5F1, 7CF1, 18L6 HD, 8C3 HD, SG-2, SG-3, SG-4, SG-5 and VF12-4 Bracket Assemblies

WARNING: The needle guide is packaged sterile and is a single-use item. Do not use if the

packaging indicates signs of tampering or if the expiration date has passed.

The needle guides for use with the CH4-1, C7F2/C5F1, 7CF1, 18L6 HD, 8C3 HD, SG-2, SG-3, SG-4, SG-5, and VF12-4 brackets are single-use items. Refer to the in-box instructions for disposal instructions.

The brackets are reusable items. Refer to the in-box instructions for cleaning and high-level disinfecting procedures for the bracket.

MC9-4, EC9-4 and EV-8C4 Disposable Endocavity Needle Guides

WARNING: The needle guide is packaged sterile and is a single-use item. Do not use if the

packaging indicates signs of tampering or if the expiration date has passed.

The disposable endocavity needle guide is a single-use item. Refer to the in-box instructions for disposal instructions.

MC9-4, 9EVF4 and EV-8C4 Stainless Steel Endocavity Needle Guide Kits

WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to

their first use.

The stainless steel endocavity needle guide is a reusable item. Refer to the in-box instructions for attachment and care procedures, including cleaning and sterilization.

Tracking Brackets and Needle Guides for eSieFusion Imaging

WARNING: The needle guide is packaged sterile and is a single-use item. Do not use if the

packaging indicates signs of tampering or if the expiration date has passed.

The needle guides for use with eSieFusion imaging are single-use items. Refer to the in-box instructions for disposal instructions.

Refer to the in-box instructions for cleaning and high-level disinfecting procedures for the tracking brackets.

See also: For a list of tracking brackets and needle guides compatible with eSieFusion Imaging, see Technical Description, Appendix A, Instructions for Use.

2 - 50 Instructions for Use

2 Safety and Care

Environmental Protection

Siemens recognizes its responsibility to minimize the environmental impacts of services, operations, and products. For more information, contact your local Siemens representative.

Product Recycling and Disposal

Dispose of this product according to local, state, and regional laws and regulations.

Batteries and electrical and electronic equipment can contain hazardous substances. If released, the hazardous substances can harm people and the environment.

Siemens provides disassembly instructions to treatment facilities for the safe and proper removal and recycling of electrical and electronic components in this product. For more information, contact your local Siemens representative.

To the extent required by local, state, and regional laws and regulations, Siemens has programs for the return of used products. For more information, contact your local Siemens representative.

Hazardous Substances

The 54.5 cm (21.5 inch) flat panel display monitor does not contain mercury.

Caring for Batteries

WARNING: Do not strike or drop batteries, allow batteries to contact water or other fluids,

disassemble batteries, allow conductive object to contact a battery's terminals, cause a battery to become short circuited, heat batteries, or expose batteries to fire. Any of these actions can compromise the structural integrity of a battery. Compromising the structural integrity of a battery can result in battery leakage, heat generation, fire, or explosion, causing possible personal injury.

WARNING: Do not use a battery if it leaks fluid or has changed shape. If skin or clothing comes

in contact with fluid from the battery, thoroughly wash the area immediately with clean water. If any fluid comes in contact with a user's eyes, immediately flush their eyes with water and seek medical attention.

WARNING: Replace batteries with the same or equivalent type. Use of incompatible batteries

can result in battery leakage, heat generation, fire, or explosion, causing possible personal injury.

WARNING: Do not attempt to recharge non-rechargeable batteries, such as the batteries

included on printed circuit boards. Recycle non-rechargeable batteries according to local, state, and regional laws and regulations.

For maximum battery life, do both of the following when the system is not in use:

 Keep the system plugged into the power outlet.  Ensure the mains circuit breaker is in the on position (I = ON).

Instructions for Use 2 - 51

2 Safety and Care



Contact your local Siemens representative.

Recycling Batteries

WARNING: Never dispose of batteries by burning or by flushing into any waste water system,

for example, a lavatory. Compromising the structural integrity of a battery can result in leakage or explosion and the potential for personal injury.

WARNING: Do not throw batteries into the trash. Collect and recycle used batteries separate

from other waste.

Item Handling Instructions

lithium batteries

3 System Setup

Initial Setup ......................................................................................................... 3

Moving the System ............................................................................................. 3

Using the Front Brakes .................................................................................. 3

Using the Rear Brakes .................................................................................. 4

Securing the Monitor ..................................................................................... 5

Prior to the Move ........................................................................................... 5

During the Move ............................................................................................ 6

After the Move ............................................................................................... 6

Shipping the System ...................................................................................... 7

System Startup ................................................................................................... 7

AC Tray Panel ............................................................................................... 7

Plugging in the System .................................................................................. 7

Supplying Power to the System ..................................................................... 8

Mobile QuikStart for Portable Studies (Standby) .................................... 9

Adjusting the Screen Brightness .................................................................. 10

Connecting and Disconnecting Transducers ............................................... 11

Array Transducers ................................................................................ 12

Continuous Wave Transducers ............................................................ 13

Protective Transducer Holder ............................................................... 13

Transducer Cable Management ........................................................... 14

Connecting System Accessories ................................................................. 15

Footswitch ............................................................................................ 15

Physio Cables ...................................................................................... 15

Gel Warmer .......................................................................................... 16

Virtual Communication for Remote Assistance .................................... 18

Connecting the Ultrasound System to a Network ........................................ 19

Wired Connection ................................................................................. 19

Wireless Connection ............................................................................ 19

Network Connection Icons .................................................................... 20

System Security ................................................................................................ 21

Restricting User Access and Permissions ................................................... 21

Tracking User Activities ............................................................................... 21

Disk Space Security Indicators ............................................................. 21

Input/Output Panel Connections ..................................................................... 22

Connecting Peripheral Equipment ............................................................... 23

On-Board vs. Off-Board Documentation Devices ................................. 25

System Ergonomics ......................................................................................... 26

Installing System Updates ............................................................................... 27

Instructions for Use 3 - 1

3 System Setup

3 - 2 Instructions for Use

3 System Setup

Initial Setup

WARNING: Do not tip the system in any direction more than 10 degrees. This action can cause

the system to tip over and create a risk for injury to the user or patient and damage to the system.

WARNING: Do not lean on or apply excessive force to the control panel or monitor. These

actions can cause the system to tip over and create a risk for injury to the user or patient and damage to the system.

The ultrasound imaging system is initially unpacked and installed by a Siemens representative. Your Siemens representative will verify the operation of the system. Any transducers, documentation devices, accessories, and options delivered with your system are also connected and installed for you.

Moving the System

WARNING: Preparations before moving the system are important to minimize potential damage

to sensitive components and to avoid safety hazards. Review the moving instructions before moving the system.

WARNING: Do not park, or leave unattended, on a slope. Even when the rear brakes are

engaged, the system may slide down a ramp.

The ultrasound system is designed to be a mobile unit. Before moving the system to another location, you must prepare for the move by powering off and securing the system.

Using the Front Brakes

Front Brake.

The front brakes (on the wheels nearest you when you face the control panel on the ultrasound system) are set differently from the rear brakes.

The front brakes are set simultaneously from a foot pedal in the central section of the system front bumper as either unlocked, locked swivel, or locked.

Positions of the front brake.

1 Locked swivel (wheels only roll

straight forward or backward)

2 Unlocked (wheels can swivel

and roll)

3 Locked (wheels cannot swivel

or roll)

Instructions for Use 3 - 3

3 System Setup

Task

Procedure

the brakes lock into place. This is the lowest position for the front bumper.

highest position for the front bumper.

To release the rear brakes:

Using your foot, move lever to the Unlock position until you hear a click.

To set the front brakes:

To release the front brakes:

To set the swivel brakes:

To release the swivel brakes:

 Press the center section of the front bumper down firmly with your foot until

 Lift the center section of the front bumper from underneath until it clicks once,

using the top of your foot. This is the center position for the front bumper.

 Lift the center section of the front bumper from underneath firmly until the

wheels are locked in a forward position, using the top of your foot. This is the

 Press the center section of the front bumper down with your foot until it clicks

once. This is the center position for the front bumper.

Using the Rear Brakes

The rear brakes are set individually as either unlocked or locked.

Rear Brakes.

Task Procedure

To set the rear brakes:  Using your foot, move lever to the Lock position until you hear a click.



3 - 4 Instructions for Use

3 System Setup

Securing the Monitor

1 Flat panel monitor 2 Articulating arm 3 Transport lock 4 Locking pin

Example of monitor in locked position.

To lock the position of the flat panel monitor for transport:

1. Ensure the directional swivel of the wheels (swivel brakes) on the ultrasound system is locked.

2. Align the flat panel monitor to the front, center of the ultrasound system.

3. Gently tip the monitor toward the front of the system to increase visibility during transport.

4. Push and rotate the transport lock into the locked position. Ensure the locking pin engages with the hole on the articulating arm.

Prior to the Move

1. Power OFF: Briefly press and then release the power on/off switch ( ) to power off the ultrasound system. The power on/off switch is located to the right of the CD-R drive.

2. Unplug cord: Unplug the power cord from the wall outlet. Pull on the plug, NOT the cord. If applicable, also unplug the Ethernet cable.

3. Secure components: The following components must be secured or transported separately:

– Power cord: Secure the power cord to avoid rolling the system wheels over the cord. – Transducers: To ensure that the transducers are transported safely, remove each

transducer and place it in its protective carrying case.

– Gel, videotapes, and CD-R disks: Transport separately. – Control panel: Ensure the control panel is in the center position. – Flat panel monitor: Lock the flat panel monitor.

4. Release brakes: Release both the front and rear brakes.

Instructions for Use 3 - 5

3 System Setup

During the Move

Caution: When moving the ultrasound system, protect it from environmental changes including:

moisture, winds, dirt and dust, and extreme heat or cold exposure.

Caution: Avoid moving the ultrasound system on outside surfaces with loose dirt, contaminates,

or standing liquids.

Caution: Care should be taken to minimize shock and vibration of the ultrasound system. Avoid

uneven surfaces that contain an abrupt height change or jarring surface irregularities.

You can move the ultrasound system from room to room within a facility and easily reposition the system during an examination. Be careful on inclines and uneven surfaces. The ultrasound system can be moved across pavement and other hardened parking lot surfaces.

Note: The wheels of the ultrasound system must be locked when transporting by vehicle. The ultrasound system must be sufficiently anchored to the vehicle floor or walls such that it does not shift or move during transport.

After the Move

Caution: Make sure the ultrasound system has proper ventilation during operation. Do not

position the system against walls or hard surfaces that would impede free ventilation around the system.

Caution: Do not allow linens, bedding, and/or hanging curtain partitions to block the ultrasound

system's ventilation.

Caution: Obstructed fans can cause potential system overheating, system performance

degradation, or failure.

Caution: Brakes are most effective on a level surface. Never park the system on an incline

greater than five degrees.

 Position system: Make sure the system is not placed against walls or fabrics that obstruct

perimeter air flow to the system cooling fans.

 Set brakes: Set the front and rear brakes.  Unlock the flat panel monitor.  Plug in cord: Plug the power cord into a hospital-grade or local equivalent wall outlet.

If applicable, also plug the Ethernet cable into an appropriate connector.

 Power ON: Power on ( ) the ultrasound system.  Check display: After the boot-up sequence is complete, verify that the image display is

stable, that you can select a transducer, and that selections made on the control panel respond to your selection.

3 - 6 Instructions for Use

3 System Setup

Shipping the System

When shipping the system, perform the following tasks, as appropriate.

To prepare the system for shipment over long distances or rough terrain:

1. Repack the system in the factory packaging and crate according to the instructions shown on the container.

2. Load the system into a vehicle using a lift gate.

– To prevent lateral movement of the system, secure the system with cargo straps. – To prevent sudden jarring of the system during transport, provide shock cushions

beneath the system.

System Startup

WARNING: Operating the ultrasound system in close proximity to other equipment can cause

reciprocal interference. You should observe and ensure normal operation of the ultrasound system and other equipment.

The first step to operating the ultrasound system is to connect the system to a power source.

AC Tray Panel

The AC tray panel on your system may have a connector cover for protection of the power cord.

1 Power cord connector 2 Equipotential connector 3 Service diagnostic lights 4 MAINS circuit breaker I = ON  = OFF

Example of AC Tray panel with a connector cover.

Plugging in the System

WARNING: Before connecting the ultrasound system to a power supply, you must read and

understand the Electrical Safety section of Chapter 2, Instructions for Use.

The ultrasound system has a non-detachable power cord.

To plug in the system:

 Connect the power cord plug to the MAINS supply in the following manner:

– 230V systems to a 230V standard MAINS, i.e., "Schuko" receptacle

(CEE 7-7 standard).

– 115V systems to a hospital-grade MAINS receptacle. – 100V systems to a standard 100V MAINS receptacle.

Instructions for Use 3 - 7

3 System Setup

Supplying Power to the System

The ultrasound system is powered on and off using the green partial power on/off switch ( ) located on the control panel.

Siemens recommends powering off the system every 24 hours to maintain optimal performance.

Note: This switch does not completely shut down or disconnect the system from the power mains. This switch only powers on, or off, a portion of the ultrasound system. To completely disconnect the system from the power mains, the circuit breaker located on the back panel must be switched from the I to O position.

Caution: Wait approximately 20 seconds between powering the system off and then on again.

This allows the system to complete its shutdown sequence.

To power on the system:

1. Before using the system, perform the Daily Checklist.

See also: Daily Checklist, Safety and Care, Chapter 2, Instructions for Use

2. Verify the power cord is plugged into the system and then into the power supply.

3. Power on ( ) the ultrasound system.

Note: Only power on the system when the power on/off switch is flashing green and when the system is plugged into the power supply. Ensure the MAINS circuit breaker is in the on position (I = ON).

When the system is powered on, it runs through a series of self-diagnostic and calibration tests, after which the system is ready for use.

Note: The system will not run through the complete power-on routine if a problem occurs. Instead, an error code or message appears on the screen to indicate the problem. Please note the message and call your local Siemens service representative.

If you selected the Standby button during system power off, then the system is ready for use within approximately 60 seconds.

The system restarts the transfer of images if a network connection is detected upon system power on from a standby status. This restart occurs only for images that could not be transferred when the system was placed in a standby status. For example, a network connection did not exist when the system was placed in a standby status.

4. Visually check the on-screen displays and lighting indicated in the Daily Checklist.

To power off the system:

1. Briefly press and then release the power on/off switch ( ) to power off the ultrasound system.

2. Select the Shut Down button on the displayed System Shut Down dialog box. If the system is transferring images, then it will wait until the transfer is complete to

power off.

Wait approximately 20 seconds after the system powers off before powering on ( ) the ultrasound system.

3 - 8 Instructions for Use

3 System Setup

Mobile QuikStart for Portable Studies (Standby)

The QuikStart feature for portable studies decreases the time required to power the system on or off by using the installed battery to place the ultrasound system in a standby status.

The system can maintain the standby status for approximately four hours when the system's power cord is not plugged into the power supply.

To place the system in a standby status:

1. Briefly press and then release the power on/off switch ( ) to power off the ultrasound system.

2. Select the Standby button on the displayed System Shut Down dialog box.

Note: If the system detects errors that require a system shutdown, then the Standby button is not available. You can either select Cancel or power off the system.

If the system is transferring images, then it will wait until the transfer is complete to power off.

Wait approximately 20 seconds after the system powers off before powering on ( ) or unplugging the ultrasound system.

Note: Only power on the system when the power on/off switch is flashing green and when the system is plugged into the power supply. Ensure the MAINS circuit breaker is in the on position (I = ON).

Instructions for Use 3 - 9

3 System Setup

Example of monitor, front view.

Example of monitor, side view.

Adjusting the Screen Brightness

Note: Factory-defined imaging presets were created using default settings of the brightness and

contrast controls of the monitor. Adjusting the brightness and tint controls on the monitor may affect the image optimization intended by the factory-defined imaging presets.

1 Monitor On/Off LED 2 Microphone 3 Microphone On/Off LED 4 Monitor handle

1 Monitor Menu Control 2  Up (increase brightness) 3  Down (decrease brightness)

For consistency in image reproduction, adjustments to the brightness of the viewing monitor should be made prior to adjusting the print quality of installed documentation devices.

To adjust the screen brightness with the monitor controls:

1. Press the menu control on the monitor. The system displays the menu for approximately ten seconds.

Note: To immediately dismiss the menu, press the menu control.

2. Adjust the screen brightness.

– To increase the screen brightness, press the up control. – To decrease the screen brightness, press the down control. – To restore the default screen brightness, simultaneously press the up and down

controls.

3. Press the menu control to confirm the setting.

Note: If you press an unsupported key combination, the screen displays a message indicating the menu is locked. To dismiss the message, press the menu control. Or, wait a few seconds for the message to automatically close.

3 - 10 Instructions for Use

3 System Setup

Connecting and Disconnecting Transducers

Caution: Ensure that the system is in freeze before connecting and disconnecting transducers.

If a transducer is disconnected before the image is frozen, the system will display an error message. Select another transducer before continuing to use the system.

You can connect multiple transducers to the ultrasound system, with one transducer being the active transducer.

1 Three micro-pinless (MP) ports

for array transducers

2 Continuous wave transducer

port

Transducer ports.

Instructions for Use 3 - 11

3 System Setup

Array Transducers

Connect an array transducer to any of the three available array ports.

Caution: You must freeze the system before connecting or disconnecting a transducer.

Note: When transducer connectors are being attached to or disconnected from the system, resistance may be encountered due to the special shielding material inside the connectors. This is normal for these transducers.

To connect an array transducer:

1. Hold the transducer connector with the cable extending upward from the connector.

2. Insert the connector into the system port and turn the lock on the transducer connector clockwise until it locks in position.

This secures the connector in position and ensures the best possible contact.

3. Place the transducer in the transducer holder.

Example of locked (left illustration) and unlocked (right illustration) positions of the transducer connector.

To disconnect an array transducer:

Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the

transducer. Use the following instructions.

1. Turn the lock on the connector housing counterclockwise until it unlocks.

2. Firmly grasp the transducer connector and carefully remove it from the system port.

3. Store each transducer in its protective carrying case.

3 - 12 Instructions for Use

3 System Setup

Continuous Wave Transducers

Continuous wave transducer port.

Caution: You must freeze the system before connecting or disconnecting a CW transducer.

To connect a continuous wave transducer:

1. Align the connector key until it fits smoothly into the receptacle.

2. Insert the connector into the system port until it locks in position.

To disconnect a continuous wave transducer:

Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the

transducer. Use the following instructions.

1. Pull on the connector housing ring to disengage the locking mechanism. Continue pulling on the ring to remove the connector from the system port.

2. Store each transducer in its protective carrying case.

1 Connector 2 Retractable connector housing 3 Transducer cable

Example of CW transducer connector.

Protective Transducer Holder

Caution: Transducer holders have variable sizes, both in depth and diameter. To avoid

transducer damage, you must use the holder or insert provided for transducers that have small or large diameter handles or for specialty transducers, such as endocavity transducers.

After connecting a transducer to the system, place the transducer in the protective holder attached to the control panel platform. There is also a holder for the coupling agent (gel).

Transducer Holders

The transducer holders on the sides of the control panel are interchangeable and replaceable.

Instructions for Use 3 - 13

3 System Setup

Transducer Cable Management

WARNING: To avoid injury from tripping over a transducer cable, use the cable hooks on the

ultrasound system to keep the transducer cable from contact with the floor.

After you have connected and secured a transducer, drape the transducer cable through one of the cable hooks located on the ultrasound system. These hooks provide support for the transducer cables, keep cables off the floor, and help to prevent tangling of the cables when more than one transducer is connected to the system.

3 - 14 Instructions for Use

3 System Setup

Connecting System Accessories

The ultrasound system has connections for system accessories.

Footswitch

Attach the optional footswitch connector into the corresponding socket located on the front system panel.

Physio Cables

1 ECG connector 2 Aux 1 ECG plug

Example of Physio panel.

Attach the optional Physio leads and auxiliary connectors to the Physio panel, located on the left front of the system.

The optional Physio feature allows the system to display a scrolling ECG waveform on the image screen.

Note: The Physio inputs are Defibrillation Proof. However, in the event of defibrillation while using the Physio function, the Physio inputs may become saturated (overloaded). An ECG pattern may not be visible for up to 30 seconds. After this time, the Physio function should return to normal operation.

To connect the Physio cables:

 Connect the six-pin Physio cable to the socket labeled ECG on the front of the system.

Instructions for Use 3 - 15

3 System Setup

Example of the gel warmer, front view.

Example of the gel warmer, back view.

Gel Warmer

(Available only on systems with a touch screen)

WARNING: To avoid electrical shock and damage to the control panel resulting from ingress of

liquid, place the gel bottle and gel warmer on the side of the ultrasound system closest to the patient.

Caution: Do not attempt to repair or alter the gel warmer. Contact your local Siemens service

representative immediately if your gel warmer appears to be damaged or malfunctions in any way.

See also: Refer to the cleaning and disinfecting procedures in Chapter 2 in this manual.

When the ultrasound system is powered on, the gel warmer continuously heats the bottle of gel inserted into the gel warmer.

1 Temperature control 2 Power control 3 Cap for collecting gel spilled from the inverted gel bottle

3 - 16 Instructions for Use

1 Support 2 Tab 3 Label 4 Power cable connector 5 Cap

Siemens Acuson S1000, Acuson S2000, Acuson S3000 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

About the User and Reference Manuals

1 Introduction

2 Safety and Care

3 System Setup