Siemens Acuson X600, Acuson X700 User manual [gb]

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ACUSON X600 ACUSON X700 Diagnostic Ultrasound System Instructions for Use

Siemens Medical Solutions USA, Inc. 10789007-ABS-001-01-01

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www.siemens.com/healthcare

ACUSON X600, Product Version 1.0

ACUSON X700, Product Version 2.0

Software Version X700 VB20, X600 VA10

Cadence, Clarify, DIMAQ, Dynamic TCE, DTI, eSie Touch, Evolve Package, fourSight, microCase, MultiHertz, QuickSet, SuppleFlex, Siemens, SieClear, SieScape, SwiftLink, syngo, TGO, THI, Velocity Vector Imaging, X600, X700, and 3-Scape are trademarks or registered trademarks of Siemens AG or its subsidiaries and affiliates.

All other product names are trademarks or registered trademarks of their respective companies.

Siemens reserves the right to change system specifications at any time.

Global Business Unit and Legal Manufacturer

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

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 AG Medical Solutions Henkestrasse 127 91052 Erlangen Germany

Siemens Global Headquarters

Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters

Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone: +49 9131 84-0

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Chapter 1

Introduction

Chapter 2

Safety and Care

Chapter 4

Examination Fundamentals

Chapter 6

Transesophageal Transducer

Chapter 7

Specialty Transducers

Chapter 8

Physiologic Function

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:

 EV9F3

Explanation of the physiologic function.

Instructions for Use i

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Appendix A

Technical Description

Technical description of the ultrasound system.

Appendix B

Control Panel

Appendix E

Reserved for Future Use

Appendix F

Acoustic Output Reference

Acoustic output reporting tables.

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

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

Appendix D Advanced Feature Controls Explanation of the on-screen controls for advanced features.

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

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About the User and Reference Manuals

Publication

Includes

Explanation of the clinical software programs for use on the ultrasound system

Clinical references

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

 ACUSON X600 diagnostic ultrasound system  ACUSON X700 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.

Instructions for Use  Intended Audience

 Technical description of the ultrasound system  Safety and care information for the system and compatible transducers  Descriptions of all system controls  Procedures for system setup, examination fundamentals, and the biopsy

function

 Acoustic output data

Features and Applications Reference*

System Reference*  Description of customizable system settings

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

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

 Descriptions of image acquisition and optimization, including optional imaging

features

 General and exam-specific measurements and calculations  Data management



 Information about DICOM connectivity, network capabilities, and external

devices

  Information regarding the electromagnetic compatibility (EMC) testing of this

system

Instructions for Use iii

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Conventions

SET

Take a moment to familiarize yourself with these conventions.

Warnings, Cautions, and Notes

Cross-References Examples:

Customizable System Settings System settings available for customization are depicted as shown.

Keys and Controls

On-screen Objects

Selection of On-screen Objects

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.

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

Intended Use ....................................................................................................... 7

ACUSON X600 Ultrasound System ............................................................... 7

Indications for Use Statement ................................................................ 8

Transducers and Intended Applications ................................................. 9

ACUSON X700 Ultrasound System ............................................................. 12

Indications for Use Statement .............................................................. 13

Transducers and Intended Applications ............................................... 14

Image Screen Layout ........................................................................................ 18

Screen Saver ............................................................................................... 18

Sample Image Screen ................................................................................. 19

Status Bar ............................................................................................. 20

User-Defined System Settings ........................................................................ 20

QuickSets .......................................................................................................... 20

Instructions for Use 1 - 1

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1 Introduction

1 - 2 Instructions for Use

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1 Introduction

System Overview

The ACUSON X600 and ACUSON X700 systems are portable, digital diagnostic ultrasound imaging systems. The systems utilize advanced imaging processing and transducer technology. The operating systems are based on Windows technology.

The system software supports standard applications, exam-specific imaging presets, measurements, pictograms, annotations, reports, worksheets, and system diagnostics.

Operating modes for the system include:

 2D-mode  Split mode  Dual-mode  4B-mode  2D/M-mode  Anatomical M-mode (for Cardiac imaging)  Pulsed Doppler  Color Doppler  Power Doppler  Steerable Continuous Wave Doppler  Auxiliary Continuous Wave Doppler

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

Instructions for Use 1 - 3

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1 Introduction

System Review

1 User adjustable monitor 2 Storage shelf 3 Transducer cable hanger 4 Air filter 5 Black and white printer 6 Physio module (with ECG and

auxiliary connectors) 7 CD/DVD-R/W drive 8 Rear shelf 9 Power (partial) ON/OFF switch ( ) 10 Articulating arm

Example of the ultrasound system, left front view.

1 - 4 Instructions for Use

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1 Introduction

1 Alphanumeric keyboard 2 Transducer holder 3 Transducer cable hanger 4 Swivel wheel with brake 5 Transducer port for continuous wave

(pencil) transducers 6 Transducer ports 7 Integrated Gel warmer 8 Front handle 9 Back-lit control panel

Example of the ultrasound system, right front view.

Instructions for Use 1 - 5

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1 Introduction

1 Monitor 2 Cable hanger 3 Power panel with circuit breaker 4 Input/Output panel

Example of the ultrasound system, back view.

1 - 6 Instructions for Use

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1 Introduction

Intended Use

WARNING: The analysis of results from an ultrasound examination requires that you are trained

in the interpretation of diagnostic ultrasound studies and are qualified to make clinical diagnoses.

Caution: In the United States of America, federal law restricts this device to sale or use by, or

on the order of, a physician.

ACUSON X600 Ultrasound System

The ACUSON X600 ultrasound system supports the following applications:

 Abdomen  Aorta  Breast  Cardiac  Cerebrovascular  Early Obstetrics  Emergency Medicine  Fetal Echo  Gynecology  Musculoskeletal  Obstetrics  Obstetrics (Japan)  Orthopedic  Pediatric Abdomen  Pediatric Echo  Pelvic Floor  Peripheral vascular  Renal  Small Parts  Testicle  Thyroid  Transcranial  Urology  Venous

Instructions for Use 1 - 7

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1 Introduction

Indications for Use Statement

Product Indications for Use Statement

ACUSON X600 Ultrasound System

The ACUSON X600 ultrasound imaging system is intended for the following applications: Cardiac Adult, Cerebrovascular, Peripheral Vascular, Transcranial, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Musculo-skeletal Conventional, Obstetrical, Gynecological (including monitoring of ovarian follicle development), and Urological applications using different ultrasound transducers for different applications.

The recommended use of each transducer may vary depending on the transducer design, anatomical study, patient size and imaging approach. The system also provides the ability to measure anatomical structures and supports 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.

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.

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.

Note: This feature can 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."

1 - 8 Instructions for Use

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1 Introduction

CURVED AND LINEAR ARRAY TRANSDUCERS

Transducers and Intended Applications

EMC Note: Operating the transducer in close proximity to sources of strong electromagnetic fields,

such as radio transmitter stations or similar installations may lead to temporary degradation or interference visible on the monitor screen. A lightening of image background may be noticed while visualizing hypoechoic structures, or color spectral interference, or jitter, or horizontal lines in the image screen may occur. The transducer and the system have been designed and tested to withstand such interference and will not be permanently damaged.

See Also: Electromagnetic Emissions and Immunity Guidance and Manufacturer's Declaration

Only the following transducers from Siemens are compatible with the Siemens ACUSON X600 ultrasound imaging system.

TRANSDUCER NAME

OPERATING FREQUENCY

MODES OF OPERATION2

INTENDED APPLICATIONS

CH5-2 2D-mode:

2.5 MHz–5.0 MHz Doppler:

2.0 MHz–2.7 MHz

C6-2 2D-mode:

3.1 MHz–5.0 MHz Doppler:

2.5 MHz–3.3 MHz

VF10-5 2D-mode:

6.2 MHz–10.0 MHz Doppler:

5.3 MHz–6.2 MHz

2D, C, D, M  Abdomen

 Early Obstetrics  Emergency Medicine  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Peripheral Vascular  Renal  Urology  Venous

2D, C, D, M  Abdomen

 Aorta  Early Obstetrics  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Pediatric Abdomen  Renal  Venous

2D, C, D, M  Breast

 Cerebrovascular  Emergency Medicine  Musculoskeletal  Orthopedics  Peripheral Vascular  Testicle  Thyroid  Venous

Instructions for Use 1 - 9

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1 Introduction

NAME

FREQUENCY1

OPERATION2

INTENDED APPLICATIONS

PHASED ARRAY TRANSDUCERS

ENDOCAVITY TRANSDUCERS

fourSight 4D TRANSDUCERS

Pelvic Floor

TRANSDUCER

OPERATING

VF12-4 2D-mode:

6.2 MHz–11.4 MHz Doppler:

4.0 MHz–6.7 MHz

4V1c 2D-mode:

1.7 MHz–4.0 MHz Doppler:

1.8 MHz–2.5 MHz

EC9-4w 2D-mode:

4.2 MHz–7.3 MHz Doppler:

4.0 MHz–5.3 MHz

MODES OF

2D, C, D, M  Breast

 Cerebrovascular  Emergency Medicine  Musculoskeletal  Orthopedic  Peripheral Vascular  Small Parts  Testicle  Thyroid  Venous

2D, C, D, M, SCW  Abdomen

 Cardiac  Emergency Medicine  Transcranial

2D, C, D, M  Early Obstetrics

 Gynecology  Obstetrics  Obstetrics (Japan)  Urology

C6F2 2D-mode:

2.9 MHz–5.0 MHz Doppler:

2.5 MHz–3.1 MHz

C8F3 2D-mode:

3.3 MHz–5.7 MHz Doppler:

2.7 MHz–3.3 MHz

EV9F3 2D-mode:

4.7 MHz–8.0 MHz Doppler:

4.0 MHz–5.3 MHz

2D, C, D, M  Abdomen

 Early Obstetrics  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)



2D, C, D, M  Abdomen

 Early Obstetrics  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Pelvic Floor

2D, C, D, M  Early Obstetrics

 Gynecology  Obstetrics  Obstetrics (Japan)  Pelvic Floor

1 - 10 Instructions for Use

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1 Introduction

NAME

FREQUENCY1

OPERATION2

INTENDED APPLICATIONS

Operating Frequency

Range of selectable operating frequencies for:

2D (brightness mode)

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

transducers)

TRANSDUCER

OPERATING

MODES OF

CONTINUOUS WAVE TRANSDUCERS

CW2 2 MHz CW  Cardiac

 Pediatric Echo

CW5 5 MHz CW  Cerebrovascular

 Pediatric Echo

2D-mode Fundamental and harmonic imaging, including contrast Doppler Pulsed wave, continuous wave, and color imaging

Modes of Operation Includes one or more of the following system operating modes

C (color flow imaging) Color Doppler, Power Doppler D (Doppler)

Pulsed Wave Doppler, 2D/Doppler, 2D/Doppler with Color, 2D/Doppler with Power

M (motion mode)

M-mode, M-mode with THI, 2D/M-mode, 2D/M-mode with Color, 2D/M-mode with Power

SCW (steerable continuous wave

Steerable Continuous Wave Doppler (for phased array transducers)

Doppler) CW (continuous wave Doppler)

Auxiliary Continuous Wave Doppler (for continuous wave [pencil]

Instructions for Use 1 - 11

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1 Introduction

ACUSON X700 Ultrasound System

The ACUSON X700 ultrasound system supports the following applications:

 Abdomen  Breast  Cardiac  Cerebrovascular  Early Obstetrics  Emergency Medicine  Fetal Echo  Gynecology  Musculoskeletal  Neonatal Head  Obstetrics  Obstetrics (Japan)  Orthopedic  Pediatric Abdomen  Pediatric Echo  Pelvic Floor  Penile  Peripheral vascular  Renal  Small Parts  Superficial Musculoskeletal  TEE (Adult transesophageal)  Testicle  Thyroid  Transcranial  Urology  Venous

1 - 12 Instructions for Use

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1 Introduction

Indications for Use Statement

Product Indications for Use Statement

ACUSON X700 Ultrasound System

The ACUSON X700 ultrasound imaging system, is intended for the following applications: Cardiac Adult, Cardiac Pediatric, Cardiac Transesophageal, Intracardiac Echo, Cerebrovascular, Peripheral Vascular, Transcranial, Fetal, Abdominal, Intra-operative (Specification), Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Musculoskeletal Conventional, Musculo-skeletal Superficial, Obstetrical, Gynecological (including monitoring of ovarian follicle development), and Urological applications using different ultrasound transducers for different applications.

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.

ACUSON AcuNav Ultrasound Catheter

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 - 13

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1 Introduction

CURVED AND LINEAR ARRAY TRANSDUCERS

Transducers and Intended Applications

EMC Note: Operating the transducer in close proximity to sources of strong electromagnetic fields,

See Also: Electromagnetic Emissions and Immunity Guidance and Manufacturer's Declaration

Only the following transducers from Siemens are compatible with the Siemens ACUSON X700 ultrasound imaging system.

TRANSDUCER NAME

OPERATING FREQUENCY

MODES OF OPERATION2

INTENDED APPLICATIONS

4C1 2D-mode:

2.2 MHz-5.0 MHz Doppler:

2.2 MHz-3.1 MHz

6C2 2D-mode:

2.5 MHz-5.7 MHz Doppler:

2.7 MHz-3.6 MHz

C8-5 2D-mode:

4.2 MHz-7.6 MHz Doppler:

4.2 MHz-5.0 MHz

VF10-5 2D-mode:

6.2 MHz-10.0 MHz Doppler:

5.3 MHz-6.2 MHz

2D, C, D, M

 Abdomen  Early Obstetrics  Emergency Medicine  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Peripheral Vascular  Renal  Urology  Venous

2D, C, D, M  Abdomen

 Early Obstetrics  Emergency Medicine  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Renal

2D, C, D, M  Cerebrovascular

 Neonatal Head  Pediatric Abdomen  Pediatric Echo

2D, C, D, M  Breast

 Cerebrovascular  Emergency Medicine  Musculoskeletal  Orthopedics  Peripheral Vascular  Testicle  Thyroid  Venous

1 - 14 Instructions for Use

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1 Introduction

TRANSDUCER NAME

FREQUENCY1

OPERATION2

INTENDED APPLICATIONS

PHASED ARRAY TRANSDUCERS

4.0 MHz-5.0 MHz

OPERATING

VF12-4 2D-mode:

6.2 MHz-11.4 MHz Doppler:

4.0 MHz-6.7 MHz

VF16-5 2D-mode:

8.0 MHz-13.3 MHz Doppler:

5.3 MHz-6.2 MHz

4V1c 2D-mode:

1.7 MHz-4.0 MHz Doppler:

1.8 MHz-2.5 MHz

P8-4 2D-mode:

3.8 MHz-6.7 MHz Doppler:

3.6 MHz-4 MHz

V5Ms 2D-mode:

4.0 MHz-5.7 MHz Doppler:

3.6 MHz

AcuNav 8F/ SoundStar eco 8F

2D-mode:

5.0 MHz-8.9 MHz Doppler:

4.0 MHz-5.0 MHz

AcuNav 10F/ SoundStar 10F/ SoundStar eco 10F

2D-mode:

5.0 MHz-8.9 MHz Doppler:

MODES OF

2D, C, D, M  Breast

 Cerebrovascular  Emergency Medicine  Musculoskeletal  Orthopedics  Peripheral Vascular  Small Parts  Testicle  Thyroid  Venous

2D, C, D, M  Breast

 Cerebrovascular  Emergency Medicine  Penile  Superficial Musculoskeletal  Testicle  Thyroid

2D, C, D, M, SCW

 Abdomen  Cardiac  Emergency Medicine  Transcranial

2D, C, D, M, SCW

 Neonatal Head  Pediatric Abdomen  Pediatric Echo  Renal

2D, C, D, M,

 Transesophageal Echo

SCW

2D, C, D, M, SCW

 Cardiac Adult  Cardiac Pediatric  Intra-Cardiac

2D, C, D, M, SCW

 Cardiac Adult  Cardiac Pediatric  Intra-Cardiac

Instructions for Use 1 - 15

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1 Introduction

TRANSDUCER NAME

FREQUENCY1

OPERATION2

INTENDED APPLICATIONS

Urology

fourSight 4D TRANSDUCERS

OPERATING

MODES OF

ENDOCAVITY TRANSDUCERS

EC9-4w 2D-mode:

4.2 MHz-7.3 MHz Doppler:

4.0 MHz-5.3 MHz

2D, C, D, M  Early Obstetrics

 Gynecology  Obstetrics  Obstetrics (Japan)  Urology

MC9-4 2D-mode:

4.2 MHz-7.3 MHz Doppler:

4.0 MHz-5.3 MHz

2D, C, D, M  Early Obstetrics

 Gynecology  Obstetrics  Obstetrics (Japan)



C6F2 2D-mode:

2.9 MHz-5.0 MHz Doppler:

2.5 MHz-3.1 MHz

2D, C, D, M  Abdomen

 Early Obstetrics  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Pelvic Floor

C8F3 2D-mode:

3.3 MHz-5.7 MHz Doppler:

2.7 MHz-3.3 MHz

2D, C, D, M  Abdomen

 Early Obstetrics  Fetal Echo  Gynecology  Obstetrics  Obstetrics (Japan)  Pelvic Floor

EV9F3 2D-mode:

4.7 MHz-8.0 MHz Doppler:

4.0 MHz-5.3 MHz

2D, C, D, M  Early Obstetrics

 Gynecology  Obstetrics  Obstetrics (Japan)  Pelvic Floor

CONTINUOUS WAVE TRANSDUCERS

CW2 2 MHz CW  Cardiac

 Pediatric Echo

CW5 5 MHz CW  Pediatric Echo

 Cerebrovascular

1 - 16 Instructions for Use

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1 Introduction

Operating Frequency

Range of selectable operating frequencies for:

Modes of Operation

Includes one or more of the following system operating modes

C (color flow imaging)

Color Doppler, Power Doppler

2D-mode Fundamental and harmonic imaging, including contrast Doppler Pulsed wave, continuous wave, and color imaging

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

D (Doppler)

M (motion mode)

SCW (steerable continuous wave Doppler)

CW (continuous wave Doppler)

Pulsed Wave Doppler, 2D/Doppler, 2D/Doppler with Color, 2D/Doppler with Power

M-mode, M-mode with THI, 2D/M-mode, 2D/M-mode with Color, 2D/Mmode with Power

Steerable Continuous Wave Doppler (for phased array transducers)

Auxiliary Continuous Wave Doppler (for continuous wave [pencil] transducers)

Instructions for Use 1 - 17

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1 Introduction

Image Screen Layout

The monitor on the ultrasound system displays clinical images together with important operating parameters and patient data. There is a variety of on-screen overlays and graphical objects to aid in image evaluation.

Many fields or areas of data displayed on the screen are multi-functional. The image field can display a 2D-mode image, M-mode sweep, Doppler spectrum, and their combinations, sets of calipers, pictograms and annotation text, and CINE icons. An image can be inverted on a vertical axis and reversed on a horizontal axis to facilitate viewing and measurements.

The system displays reduced-size reference images (thumbnails) of images, clips, and volumes stored during the exam.

EMC Note: Operating the ultrasound imaging system in close 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.

Screen Saver

The screen saver feature automatically replaces the display with a blank screen after the system has been inactive for a specified number of minutes.

When the screen saver is activated, the system is automatically placed into freeze mode.

Restore the screen display by pressing any key or adjusting any control. The first key that you press will restore the view without performing a function. Press the key again to execute the command.

Use the system presets to enable the screen saver feature and to specify the delay period and the background for the blank screen.

Display > Monitor > Enable Screen Saver

Display > Monitor > Screen Saver Delay

Display > Monitor > Screen Saver Type

1 - 18 Instructions for Use

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1 Introduction

Sample Image Screen

Example of a typical image screen.

1 Information for identifying the patient, operator, and the hospital or clinic. 2 Time and Date 3 Panels including Thumbnails with controls for printing, deleting, and deselecting an image, clip, or

volume, Patient Info for displaying patient information and Results for displaying measurement results.

4 Soft key selections for a mode or function, including controls for image optimization, post-processing,

measurement types, annotations, and playback. Use the corresponding toggle key on the control panel to activate the selection. Rotate the PAGE control on the control panel to access additional selections for the mode or function. Press the PAG E control to access soft key selections for other modes or functions.

5 Status bar. Indicates the function currently assigned to the trackball, SELECT control, UPDATE key,

ESCAPE key.

Provides an indication of the following functions: video recording or paused recording, signal strength of

the wireless connection signal, and insert text or overwrite text for annotations. 6 Tab Indicator. Identifies the mode or function for the soft key selections. 7 Page Indicator for the soft key selections. The number of available "pages" for a specific mode or

function are identified by the number of sections in the "page indicator". The highlighted section

corresponds to the displayed "page" of soft key selections. 8 During the Measurement function, the system displays the Measurement Label menu for the priority

imaging mode and exam type. Use the CALIPER key to access the Measurement Menu. 9 Imaging Parameters. Displays settings for parameters adjusted by the soft key selections. 10 Transducer Frequency 11 Gain for the priority mode 12 Active Exam type 13 Active transducer name

Instructions for Use 1 - 19

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1 Introduction

if any.

Status Bar

Icon Description

Indicates the function currently assigned to the SELECT control.

Indicates the function currently assigned to the UPDATE key.

Indicates the function currently assigned to the ESCAPE key. Press the ESCAPE key to cycle through the functions for other active modes under control of the key,

Indicates the function currently assigned to the trackball. Press the SET key to cycle through other functions under control of the trackball, if any.

Indicates recording status during video recording using a DVR. A red icon displays during recording and a white icon displays during pause. The recording time also displays beside the icon.

When displayed, indicates recording function with the built-in microphone is activated.

Indicates strength of wireless connection signal.

User-Defined System Settings

You can customize many features of the ultrasound system by using the system presets to designate default settings, or presets. The values are stored in non-volatile memory and will remain intact when the system is powered off.

Each user of the system can determine settings for imaging preferences and default settings, then store them on a disk. Those user-defined settings can then be loaded along with new system software. The disk also serves as a backup.

QuickSets

The QuickSet feature allows you to capture an optimized configuration of imaging parameter settings for a combination of a specific transducer and exam.

1 - 20 Instructions for Use

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2 Safety and Care

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

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

Labels ............................................................................................................ 8

Biohazard Considerations............................................................................ 10

Note on Fetal Examinations ................................................................. 11

Acoustic Output — Mechanical and Thermal Indices .................................. 11

Mechanical and Thermal Indices .......................................................... 12

Transmit Power Control ........................................................................ 13

Transmit Power Display........................................................................ 14

Imaging Functions that Change Acoustic Output ................................. 15

Transducer Surface Temperature Limits ..................................................... 16

Electrical Safety ........................................................................................... 17

Level of Protection Against Electrical Shock — Transducers ............... 19

Defibrillators ......................................................................................... 19

Defibrillator Use and the ACUSON AcuNav Ultrasound Catheter ........ 19

Implantable Devices ............................................................................. 19

Possible Combinations with Other Equipment ...................................... 20

Maintaining Data Integrity ............................................................................ 21

Caring for the Ultrasound System ................................................................... 22

Daily Checklist ............................................................................................. 22

Maintenance ................................................................................................ 23

Repair ................................................................................................... 23

Siemens Authorized Care..................................................................... 23

Cleaning and Disinfecting ............................................................................ 24

Cleaning and Disinfecting the System .................................................. 24

Cleaning an Air Filter ............................................................................ 27

Caring for the Battery Pack .......................................................................... 29

Battery Pack Location .......................................................................... 29

Battery Pack Replacement and Disposal ............................................. 30

Caring for Documentation and Storage Devices ........................................... 31

Caring for Transducers .................................................................................... 31

Cleaning and Disinfecting Transducers ....................................................... 32

IPX8 Immersion Levels......................................................................... 33

Approved List of Pre-Cleaners and Low-Level Disinfectants ................ 35

Approved List of Disinfectants .............................................................. 36

Storage ........................................................................................................ 37

Repair .......................................................................................................... 37

Protective Case ........................................................................................... 37

Instructions for Use 2 - 1

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2 Safety and Care

Caring for Transducer Accessories ................................................................ 38

Transducer Sheaths .................................................................................... 38

Storage ................................................................................................. 38

Gel Pad........................................................................................................ 39

Storage ................................................................................................. 39

Needle Guide Bracket Kits........................................................................... 39

Storage and Transportation .................................................................. 39

Cleaning, Disinfecting, and Sterilizing Transducer Accessories .................. 40

Needle Guide Bracket Kits ................................................................... 40

Storage ................................................................................................. 42

Environmental Protection ................................................................................ 43

Product Recycling and Disposal .................................................................. 43

Hazardous Substances ........................................................................ 43

Caring for Batteries ...................................................................................... 44

Recycling Batteries ...................................................................................... 45

Disposing of the Packaging Materials .......................................................... 46

Disposing of Components and Accessories ................................................ 46

Energy Conservation ................................................................................... 46

2 - 2 Instructions for Use

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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

Refer to this table to identify important symbols located on the ultrasound imaging system and transducers.

Alternating Current

V~ AC (alternating current) voltage source

Caution: Risk of electric shock

Type BF Defibrillator-proof Patient Connection

Type BF Applied Part

Type CF Patient Connection

Consult Instructions for Use

Operating Instruction – Mandatory Action (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)

Monitor Menu Control

Monitor Menu Control, up (increase)

Monitor Menu Control, down (decrease)

Monitor Picture menu icon

Monitor Function menu icon

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2 Safety and Care

Symbol

Explanation

B/W

Monitor OSD menu icon

Monitor menu Exit icon

Protective Earth Ground

Signal Earth Ground

Signal Input

Signal Output

Video Connection (monochrome video signals)

Start (of action for equipment)

USB Connection

Ethernet 10/100BaseT Connection

Equipotential Connection

Printer Connection

Black and White Printer Connection VGA

Digital Video Interface (DVI)

Intentional transmitter of non-ionizing radiation.

Electronic Array Transducer Port

Continuous Wave Doppler Transducer Port

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Symbol

Explanation

IPX8

EEC directive(s)

Unlocked position

Locked position

Audio

Do not lean against the monitor.

Shelf Weight Restriction

ON only for MAINS control

OFF only for MAINS control

Power "On" standby switch

ECG Socket

IVK

Protected against the effects of continuous immersion in water Do not open. Refer servicing to qualified service personnel.

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

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

Manufacturer's declaration of product compliance with applicable

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

Gost-R symbol indicates that this product is certified for conformity to the safety requirements of Russian state standards

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

traceability UL classified symbol for Canada and United States of America

Bar Code

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2 Safety and Care

Symbol

Explanation

Environmentally friendly use period

Manufacturer

Date of Manufacture symbol with the date below

Do not install wet

Location of air filter

Storage temperature 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.

Do not dispose of by dumping in garbage. Use a separate collection for electrical and electronic equipment.

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.

2 - 6 Instructions for Use

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2 Safety and Care

Symbol

Explanation

WATCH YOUR HAND

Fuse

Pinch hazard WARNING: PINCH POINT

Control panel swivel

Control panel height adjustment

External input/output converter box

Instructions for Use 2 - 7

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2 Safety and Care

Labels

Location of labels.

1 Monitor label 2 System warning and Certification label 3 Identification label

Example of monitor label.

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2 Safety and Care

Example of system warning label with certification labels.

Example of identification label.

1 Product name 2 Product status number 3 Serial number 4 Serial number barcode 5 Model number 6 Model number barcode 7 Manufacturing date

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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: 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 of hazardous or infectious materials according to local, state, and regional regulations.

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

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

The assessment of the biological effects of diagnostic ultrasound on humans is a subject of ongoing scientific research. This 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 ALARA (As Low As Reasonably Achievable) principles, acoustic output should be set to 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), the National Electrical Manufacturer's Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA), and the guidelines 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 system settings in the event of new research findings being announced.

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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).

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.

Note: For 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 ultrasound system.

See also: Acoustic Output Reference, Appendix F, Instructions for Use

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Mechanical and Thermal Indices

The system displays the Mechanical Index during real time imaging, in all imaging modes. The system displays the Thermal Indices during real-time imaging when the value is equal to or exceeds 0.4.

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

Location of mechanical and thermal indices on the image screen.

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 CAI exams only)

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

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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 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.

See also: Imaging Functions that Change Acoustic Output, p. 2-15

Note: Maximum transmit acoustic intensity and the mechanical index for each exam type are 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, press the toggle key for P upward to increase transmit power.

To decrease the transmit power:

 During real-time imaging, press the toggle key for P downward to decrease transmit power.

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2 Safety and Care

Percentage (%)

Decibels (dB)

Percentage (%)

Decibels (dB)

50%

-6 dB

2.0%

-34 dB

16%

-16 dB

0.63%

-44 dB

6.3%

-24 dB

0.25%

-52 dB

Transmit Power Display

The transmit power range is from 0.20% to 100%. Selecting 100%, in combination with other 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

100% 0 dB 4.0% -28 dB 79% -2 dB 3.2% -30 dB 63% -4 dB 2.5% -32 dB

40% -8 dB 1.6% -36 dB 32% -10 dB 1.3% -38 dB 25% -12 dB 1.0% -40 dB 20% -14 dB 0.79% -42 dB

13% -18 dB 0.40% -46 dB 10% -20 dB 0.50% -48 dB

7.9% -22 dB 0.32% -50 dB

5.0% -26 dB 0.20% -54 dB

Comparison of decibels to percentages.

When the power level is changed, the system briefly highlights the power value to indicate the change.

Location of power display on the image screen.

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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  M-mode cursor  Color and Power ROI Position and Size; Steering Angle for linear array transducers  Doppler Gate Position and Size; Steering Angle for linear array transducers  Doppler PRF  Color PRF  Exam Type  Field of View (Scan Angle); 2D Steering Angle for linear array transducers  Focus  Zoom  Frame Rate  Freeze  Image Depth  Imaging Mode  Multi-Frequency  Power On/Off  System Presets and QuickSets  THI  Resolution/Speed  Simultaneous/Update  Transducer  Gel pad use

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Transducer

TMM

Still Air

<30.7° C

<44.3° C

<29.8° C

<36.4° C

<29.5° C

<36.5° 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.

Note: The systemic uncertainty of the transducer surface temperature is estimated as 1.41%.

Maximum Temperature

4C1 CH5-2 6C2 C6-2 C8-5 VF10-5 VF12-4 VF16-5 C6F2 C8F3 EV9F3 EC9-4w MC9-4 4V1c P8-4 V5Ms AcuNav 8F AcuNav 10F SoundStar 10F SoundStar eco 8F SoundStar eco 10F CW2 CW5

TMM = Tissue Mimicking Material

<32.1° C <41.6° C <31.2° C <42.7° C <32.7° C <43.5° C <31.4° C <42.1° C <28.9° C <38.8° C <33.2° C <44.5° C <32.0° C <44.8° C <28.8° C <41.7° C <28.8° C <40.2° C <26.4° C <39.4° C <28.3° C <43.2° C <30.7° C <44.3° C

<32.8° C <45.5° C <29.4° C <39.3° C <30.3° C <43.2° C <29.5° C <36.5° C

<29.8° C <36.4° C

<29.8° C <36.4° C <30.6° C <40.2° C <29.4° C <38.1° C

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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 systems used in the U.S.A.: 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's 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 whose ground plug has been bypassed 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 imaging

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 and gel warmer on the side of the system closest to the patient.

WARNING: 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.

WARNING: 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.

Instructions for Use 2 - 17

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2 Safety and Care

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.

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.

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: To reduce the risk of fire and subsequent equipment damage, use only 26 gauge

(0.14 mm

) or heavier wire for the cable connecting to the Ethernet port located on the

ultrasound system.

EMC Note: Operating the ultrasound system in close 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.

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Level of Protection Against Electrical Shock — Transducers

WARNING: Only use Type BF transducers with the ultrasound system to maintain a level of

protection against electrical shock.

According to EN 60601-1 and IEC 60601-1, the assemblies for 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.

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.

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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 EN 60601-1 and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards EN 60601-1-1 and IEC 60601-1-1. 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 EN 60601-1-1 and IEC 60601-1-1. 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 can support two on-board documentation devices at one time.

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.

Barcode Reader

WARNING: To avoid electrical shock, do not connect the barcode reader to the system when

more than two on-board documentation devices are connected to the system.

WARNING: Do not stare into the beam of the barcode reader. This action can create a risk for

injury to the user.

You can connect a Siemens-approved barcode reader directly to a USB port on the ultrasound system. The barcode reader provides direct entry of patient information in the registration form, for example, patient name, patient identifier, or physician identifier.

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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 partial power on/off switch ( ) located on the control panel. Other examples of abnormal system shutdown include: equipment malfunction, loss of power, or pressing and holding the 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.

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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 system, including the control panel, keyboard, and transducers, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to kill vegetative organisms and viruses.

The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter 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 the approved disinfectants, Cidex OPA and Gigasept FF, may cause discoloration of transducer housings, including the face of the transducer. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

See also: Approved List of Disinfectants, p. 2-36

Perform the following each day before using the ultrasound system:

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

or discolored casing or a frayed cable.

 Visually inspect all power cords. Do not turn on the power if a cord is frayed or split, or

shows signs of wear. If your system's power cord is frayed or split, or shows signs of wear, contact your Siemens

service representative for power cord replacement.

 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 are

clean and free from gel or other contaminants.

Once the 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.

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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

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

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.

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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 imaging system that come in contact with human blood or other body fluids as if they were known to be infectious.

All exterior parts of the system, including the control panel, and transducers, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect the components to kill vegetative organisms and viruses.

Cleaning and Disinfecting the System

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

disconnect the equipment from the AC power source before cleaning and disinfecting.

WARNING: Contents of some disinfecting agents are known to be health hazards. Their

concentration in the air must not exceed an applicable specified limit. Comply with the manufacturer's instructions when using these agents.

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 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. Isopropyl alcohol exception: It is acceptable to use isopropyl alcohol only when recommended for cleaning the trackball assembly. Use the recommended cleaning procedure.

See also: Trackball Cleaning, p. 2-25

Caution: Do not use spray cleaners on the ultrasound system, or pour fluid onto the system

surfaces, as fluid can seep 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.

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System Surfaces

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

After cleaning system surfaces, including the trackball and transducer holder, you can disinfect the surface with an approved disinfectant wipe.

To clean 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.

Take particular care to clean the areas near the trackball and the slide controls. Ensure these areas are free of 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. After cleaning, reconnect the ultrasound system power cord into the power outlet.

To clean the liners of the transducer holders:

1. Remove the liner from the transducer holder.

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

3. Reinsert the liner into the transducer holder.

See also: System Setup, Chapter 3, Instructions for Use

To clean the trackball:

Caution: Do not drop or place foreign objects inside the trackball assembly. This may affect the

trackball's operation and damage the system.

Caution: Do not submerge the front bezel and Teflon seal in isopropyl alcohol - this may

damage the adhesive bond between the two components.

1. Remove the trackball front panel bezel by rotating the bezel counterclockwise.

2. Remove the ball.

3. Clean the ball with tissue and isopropyl alcohol.

4. Clean the Teflon seal (located in the front panel bezel) with a tissue and isopropyl alcohol.

5. Clean the inside of the trackball assembly with a cotton swab and isopropyl alcohol.

6. Allow the assembly parts to completely dry before reassembly.

7. Replace the ball and front panel bezel.

Instructions for Use 2 - 25

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2 Safety and Care

Ultrasound System

Transducer Liners

Trackball Assembly

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 components.

Sani-Cloth

                 

*or any bleach wipe with <1% sodium hypochlorite and no other active ingredients  = compatible NC = not compatible NA = not applicable (not tested)

Sani-Cloth

AF3

Sani-Cloth

Bleach Wipe*

Sani-Cloth

Plus

Super

Sani-Cloth

2 - 26 Instructions for Use

Page 55

2 Safety and Care

Cleaning an Air Filter

The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter weekly, and clean as needed.

The filter location is marked with the air filter symbol.

Location of air filter.

Instructions for Use 2 - 27

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2 Safety and Care

To remove and clean the 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. Grasp the air filter tray and pull it out of the system.

1 Air filter 2 Air filter tray

Removing the air filter tray.

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

lint-free cloth.

Caution: Do not insert the air filter tray into the ultrasound system with a wet filter as this can

damage the system.

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

5. Plug the power cord into the power outlet.

2 - 28 Instructions for Use

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2 Safety and Care

Caring for the Battery Pack

WARNING: Do not strike or drop the battery pack because this can cause heat generation,

bursting, or fire. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

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

comes in contact with fluid from the battery pack, 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: Do not allow the battery pack to contact water. Compromising the structural integrity

of the battery pack can result in leakage or explosion and the potential for personal injury.

WARNING: Do not disassemble the battery pack. Compromising the structural integrity of the

battery pack can result in leakage or explosion and the potential for personal injury.

The battery pack is designed to maintain system memory for a maximum of twenty minutes.

The length of the charge time is three hours.

Battery Pack Location

The battery pack is located on the front side of the ultrasound system, where the power is located. The battery pack cover must be removed to access the battery pack.

Battery pack location.

1 Battery pack location

Instructions for Use 2 - 29

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2 Safety and Care

+ +

Battery Pack Replacement and Disposal

Replace the battery pack when it is no longer able to hold a charge.  When the system is used with the Mobile QuikStart option and frequently disconnected

from the AC power (for a duration of greater than 20 minutes), replace the battery every 6 months.

 When the system is used with the Mobile QuikStart option and only occasionally

disconnected from the AC power (for a duration of approximately 20 minutes), replace the battery every year.

1 AC OK indicator LED 2 Battery pack charge indicator LED

Example of an AC Tray panel with the battery pack charge indicator LED.

The battery pack charge indicator LED is located at the rear of the system, on the AC Tray panel. A green blinking LED indicates that the battery is actively charging. A solid green LED indicates that the battery pack is fully charged. If the LED is not illuminated, then there is a problem with the battery pack, or the battery pack may be missing.

2 - 30 Instructions for Use

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2 Safety and Care

Caring for Documentation and Storage Devices

Caution: Computer viruses on a USB-compatible device can infect the ultrasound system.

Check for viruses before connecting the device to the system.

Note: Study data stored directly to a USB device can be lost. Do not use a USB device for permanent data storage.

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

Caring for Transducers

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

intraoperative transducers must be cleaned and high-level disinfected after each use.

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.

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

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

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

the patient leakage currents may be additive.

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.

Caution: To avoid cable damage, do not roll the 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.

Instructions for Use 2 - 31

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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 which 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 cable or connector of a transducer to become wet.

Caution: The transducers have been designed and tested to be able to withstand high-level

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 cleaning agents, organic solvents such as benzene, isopropyl

alcohol, or phenol-based substances, or cleaning agents containing organic solvents to clean or disinfect transducers. These substances can damage the transducers.

Caution: Do not use a spray cleaner on a transducer, as this may force cleaning fluid inside the

housing and damage the transducer.

All transducers should be cleaned and disinfected prior to their use on each patient. Endocavity and intraoperative transducers require high-level disinfection prior to use.

See also: Transesophageal Transducer, Chapter 6, Instructions for Use

2 - 32 Instructions for Use

Page 61

2 Safety and Care

To clean a transducer:

1. Disconnect the transducer from the system.

2. Moisten a clean gauze pad with water and wipe the transducer to remove any gel or particles remaining on the transducer. If water is not effective, then you can use an approved pre-cleaner or low-level disinfectant.

3. Carefully wipe the entire transducer, including the cable and connector.

4. After cleaning or disinfecting, use a clean cloth to dry the transducer.

To disinfect or high-level disinfect a transducer:

1. Disconnect the transducer from the system.

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

3. Take care to keep the cable strain relief and connector of the transducer dry while immersing the transducer in an approved disinfectant to the level indicated in the following illustration.

4. Carefully follow the disinfectant manufacturer's instructions for disinfection or high-level disinfection.

5. After disinfecting or high-level disinfecting, use a clean cloth to dry the transducer.

IPX8 Immersion Levels

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

transducer type. Transducers with the protection level IPX8 are indicated by the presence of the "IPX8" symbol on the connector of the transducer.

Transducers meet Ingress Protection level IPX8 of EN 60539 and IEC 60539 to the depth of the immersion line shown in the illustration only for transducers with the "IPX8" symbol on the connector of the transducer.

Example of transducer labels with IPX8 symbol.

Instructions for Use 2 - 33

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2 Safety and Care

IPX8 Immersion Levels.

1 Endocavity 2 Linear 3 Curved 4 Phased 5 fourSight 4D 6 fourSight 4D (endocavity) 7 Continuous Wave (CW) 8 V5Ms

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

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

2 - 34 Instructions for Use

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2 Safety and Care

4C1

CH5-2

    

C8-5

VF10-5

VF12-4

C8F3

EV9F3

4V1c

P8-4

V5Ms

CW5

Approved List of Pre-Cleaners and Low-Level Disinfectants

The following matrix provides a list of approved pre-cleaners and low-level disinfectants for all transducers.

Enzol Transeptic Hi-Tor Plus Theracide Plus T-Spray II Super SaniCloth

           

6C2

C6-2

VF16-5 C6F2 NA NA NA NA

EC9-4w

MC9-4

CW2

 = compatible NC = not compatible NA = not applicable (not tested)

  

    

  

NC NA NA

NA NA

     

 

   

NA NA NA NA NA



NA NA NA



       

                

NA NA

             

NA NA



Instructions for Use 2 - 35

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2 Safety and Care

Cidex

Cidex Plus

Cidex OPA

Milton

Virkon

Gigasept FF

Resert XL HLD

4C1

CH5-2

C8-5

VF10-5

VF12-4

C6F2    NA

C8F3

EV9F3

4V1c

P8-4

V5Ms

CW5      

Approved List of Disinfectants

The following matrix provides a list of approved disinfectants for all transducers.

Note: The approved disinfectants, Cidex OPA and Gigasept FF, may discolor transducer housings, including the face of the transducer. There is no associated degradation of imaging performance or transducer reliability.

             

6C2        C6-2       NA

           

VF16-5 NA NA

  

NA NA NA NA NA



NA NA NC



NA NA NA NA

  

NA NA

EC9-4w

 



     

MC9-4       NA

                 



CW2       NA

 = compatible

NC = not compatible NA = not applicable (not tested)

2 - 36 Instructions for Use

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2 Safety and Care

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.

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.

Instructions for Use 2 - 37

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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

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.

Transducer sheaths are single-use items used to ensure proper acoustic coupling and provide a prophylactic barrier for the intended ultrasound application. Sheaths are available for all transducers. Siemens recommends the use of market-cleared transducer sheaths.

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.

2 - 38 Instructions for Use

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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.

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

Storage

Do not store gel pads below 5°C nor above 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 Creutzfeld-Jacob disease, then the needle guide should be destroyed. Sterilization is not effective against Creutzfeld-Jacob contamination.

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

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

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.

Instructions for Use 2 - 39

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2 Safety and Care

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.

CH4-1, SG-3, SG-5, and Infiniti Plus Needle Guide Bracket Kits

Disposable Needle Guide

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 guide for use with the CH4-1, SG-3, SG-5, and Infiniti Plus bracket kit is a singleuse item. Refer to the in-box instructions for disposal instructions.

Reusable Bracket

WARNING: Needle Guide Bracket kits are packaged non-sterile. High-level disinfect these

products prior to their first use.

EV9F3 Reusable Needle Guide Bracket Kit (Stainless Steel)

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.

2 - 40 Instructions for Use

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2 Safety and Care

EC9-4w Disposable Needle Guide Bracket Kit

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.

EC9-4w Reusable Needle Guide Bracket Kit (Stainless Steel)

WARNING: The needle guide is packaged non-sterile. Sterilize this product prior to its 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.

VF12-4 Reusable Needle Guide Bracket Kit

WARNING: The needle guide is packaged non-sterile. Sterilize this product prior to its first use.

Refer to the in-box instructions for attachment and care procedures, including cleaning and sterilization.

Instructions for Use 2 - 41

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2 Safety and Care

Universal Reusable Needle Guide Bracket Kit S (Stainless Steel)

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

their first use. Refer to the sterilization procedures for the Reusable Needle Guide Bracket Kit S (Stainless Steel) in the following pages.

Prior to sterilization, clean the Universal Reusable Needle Guide Bracket and insert(s) using an enzymatic cleaner.

To clean:

1. Rinse the bracket and insert(s) with water.

2. Soak the bracket and insert(s) in an enzymatic cleaner. Carefully follow the manufacturer's instructions.

3. Rinse the bracket and insert(s) with water to remove any debris and remaining cleaner.

To sterilize:

 Sterilize the bracket and needle guide insert(s) using a wrapped, gravity-displacement

steam sterilization at a temperature of 121°C to 123°C for an exposure time of 15 to 30 minutes.

Storage

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

2 - 42 Instructions for Use

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2 Safety and Care

Environmental Protection

Product Recycling and Disposal

Dispose of this product according to local, state, and regional 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 laws and regulations, Siemens has programs for the return of used products. For more information, contact your local Siemens representative.

Hazardous Substances

WARNING: This product consists of devices that may contain mercury, which must be recycled

or disposed of in accordance with local, state, or federal laws.

Hazardous Substance Included in the Product? Location

Mercury Yes

A small amount of mercury (maximum

5.0 mg/lamp) is included in the backlight of the flat panel monitor.

Instructions for Use 2 - 43

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2 Safety and Care

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 regulations.

For maximum battery life, observe all of the following steps 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).  Store the system in an environment with low humidity and a temperature range between

0°C and 21°C, where possible.

2 - 44 Instructions for Use

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2 Safety and Care



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 Estimated Use Period Handling Instructions

Lithium batteries 1.5 years

Battery packs (lithium-ion battery)

6 months

Recycle batteries according to local, state, and regional regulations. Use a battery collection program available in your country to recycle batteries.

To the extent required by local laws and regulations, Siemens will collect and recycle batteries for this product at no charge. Contact your local Siemens representative for battery shipment instructions.

3 System Setup

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

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

Swivel Locking Brake .................................................................................... 4

Front Swivel Locking Brake .................................................................... 4

Back Swivel Locking Brake .................................................................... 5

Prior to the Move ........................................................................................... 6

During the Move ............................................................................................ 8

Shipping the System .................................................................................... 10

After the Move ............................................................................................. 10

System Startup ................................................................................................. 11

Plugging in the System ................................................................................ 11

Supplying Power to the System ................................................................... 12

QuikStart Feature (Battery-Powered Standby Mode) .................................. 14

Adjusting Controls on the Monitor ................................................................ 15

Controls on the Monitor ........................................................................ 15

Adjusting Brightness ............................................................................. 16

Adjusting the Monitor with the Monitor Menu Selections ...................... 17

Audio and Microphone Volume ............................................................ 18

Connecting and Disconnecting Transducers ............................................... 19

ACUSON X600 System ........................................................................ 19

ACUSON X700 System ........................................................................ 20

Array Transducers ................................................................................ 21

Continuous Wave Transducers ............................................................ 22

Protective Transducer Holder ............................................................... 23

Transducer Cable Management ........................................................... 23

Connecting System Accessories ................................................................. 23

Footswitch ............................................................................................ 23

ECG (EKG) Cables .............................................................................. 24

Auxiliary Inputs ..................................................................................... 24

Wireless Network Connections .................................................................... 25

Approved Wireless Adapters ................................................................ 25

Connecting the Wireless Adapter to the System .................................. 26

Informational Icons for the Wireless Adapter ........................................ 26

Instructions for Use 3 - 1

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3 System Setup

Input/Output Panel Connections ..................................................................... 27

Input/Output Converter Box (Video Converter) ............................................ 29

Connecting Peripheral Equipment ............................................................... 30

System Ergonomics ......................................................................................... 32

General System Settings ................................................................................. 34

Modifying Hospital or Clinic Name ............................................................... 34

Setting System Date and Time .................................................................... 34

Configuring the Documentation Controls ..................................................... 36

Software Installation ......................................................................................... 37

Software-Based Option Installation ................................................................ 39

3 - 2 Instructions for Use

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3 System Setup

Initial Setup

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

Each day before you use the ultrasound system, perform the Daily Checklist.

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

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: To avoid damage to the monitor and the potential for personal injury to the user,

ensure the monitor does not swivel during transport. Lock the vertical position of the flat panel monitor prior to moving the ultrasound system according to the directions provided in this section of the instructions.

Caution: Do not push the flat panel monitor to move the system. Pushing on the flat panel

monitor can cause loss of control over the system and damage to the moving parts of the flat panel monitor.

Caution: Do not lean on the flat panel monitor. Subjecting the flat panel monitor to heavy loads

or extreme pressure can damage the ultrasound system.

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

engaged, the system may slide down a ramp.

Caution: To prevent damage to the system during a move, retract or close any doors and trays

on the documentation devices or components on the ultrasound system. Ensure components do not protrude from the system.

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.

Instructions for Use 3 - 3

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3 System Setup

Lock the brake

Press the locking lever down with your foot into the locked position.

ON (on)

into place.

Swivel Locking Brake

The ultrasound system has four swivel locking brakes. The two front brakes each have a locking and locking release lever and a swivel and swivel release lever. The two back brakes each have a locking lever and a release lever. Set the swivel locking brakes with the levers on each wheel.

Front Swivel Locking Brake

Example of wheel with locking brake (unlocked).

1 Locking release lever 2 Locking lever 3 Swivel lock lever 4 Swivel release lever

To Do This Symbol



Release the brake

Lock the swivel

Release the swivel

 Press the locking release lever down with your foot to release

the brake.

 Press the swivel lock lever with your foot until the swivel brake locks

 Press the swivel release lever with your foot until the brake unlocks

and the lock swivel lever releases.

OFF (off)

3 - 4 Instructions for Use

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3 System Setup

Example of wheel with locking brake (locked).

Example of wheel with locking brake (unlocked).

Do This

Symbol

position

Back Swivel Locking Brake

Lock the brake

Release the brake

 Press the locking lever down with your foot into the lowest (locked)

 Press the locking release lever down with your foot to release

the brake.

ON (on)

OFF (off)

Instructions for Use 3 - 5

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3 System Setup

Prior to the Move

1. Power off the ultrasound system. The power (partial) on/off ( ) switch is located on the upper left of the control panel.

2. Unplug the power cord from the wall outlet. Pull on the plug, not the cord.

3. Secure the power cord to avoid rolling the system wheels over the cord.

4. To ensure that the transducers are transported safely, remove each transducer and place it in its protective carrying case.

5. Retract or close any doors or trays of the documentation devices or components on the ultrasound system.

Retracting open doors or trays.

6. Disconnect off-board documentation devices from the system.

7. Transport gel and CD/DVD disks separately.

8. Disconnect the optional footswitch.

3 - 6 Instructions for Use

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3 System Setup

Example of transport lock in the unlocked position.

Example of transport lock in the locked position. Example of monitor in vertical position for transport.

9. Lock the position of the flat panel monitor for transport: a. Align the flat panel monitor to the front, center of the ultrasound system. b. Push and rotate the transport lock into the locked position. Ensure the locking pin

engages with the hole on the articulating arm.

1 Pin hole 2 Transport lock

1 Pin 2 Pin hole 3 Transport lock

10. Release both the front and rear brakes.

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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.

Caution: For systems installed with an on-board documentation device located on the rear shelf

of the ultrasound system, avoid damage to cables and connectors protruding from the documentation device, particularly when moving the system around corners or through doorways.

See also: Supplying Power to the System, p. 3-12

See also: Transducers — Care, Safety and Care, Chapter 2, Instructions for Use

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Protruding cables and connectors.

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.

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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.

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.

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.