ACUSON NX3 and NX3 Elite Instruction Manual Ver 1.0 Nov 2015

ACUSON NX3, Product Version 1.0

CE Declaration

ACUSON NX3 Elite, Product Version 1.0

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.

Software Version VA10 ©2015 Siemens Medical Solutions USA, Inc. All Rights Reserved. November 2015 Printed in the Republic of Korea. 3-Scape, ACUSON NX3, Advanced SieClear, Axius, Cadence, Clarify, DTI, DTO, Dynamic TCE, eSie Touch, fourSight, MultiHertz, QuickSet, SieClear, SieScape, and TGO are trademarks of Siemens Medical Solutions USA, Inc., and syngo is a trademark of Siemens Healthcare AG. All other product names are references to third-party products and are trademarks of their respective companies. Siemens includes references to third-party products in the user documentation for informational purposes only. Siemens does not endorse third-party products referenced in the user documentation. Siemens does not assume responsibility for the performance of third-party products.

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

Siemens reserves the right to change system specifications at any time. Global Business Unit and Legal Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 685 East Middlefield Road Mountain View, CA 94043 U.S.A. Phone: +1-888-826-9702 www.siemens.com/healthcare

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

Contents Chapter 1

Introduction General overview of the diagnostic ultrasound imaging system.

Chapter 2

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

Chapter 3

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

Chapter 4

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

Chapter 5

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

Chapter 6

Reserved for Future Use

Chapter 7

Reserved for Future Use

Chapter 8

Physiologic Function Explanation of the physiologic function.

Instructions for Use

i

Appendix A

Technical Description Technical description of the ultrasound system.

Appendix B

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

Appendix C

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

Appendix D

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

Appendix E

Reserved for Future Use

Appendix F

Acoustic Output Reference Acoustic output reporting tables.

Note: Not all features and options described in this publication are available to all users. Please check with your Siemens representative to determine the current availability of features and options.

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Instructions for Use

About the User and Reference Manuals The user and reference manuals contain descriptions for the following ultrasound systems: 

ACUSON NX3 diagnostic ultrasound system



ACUSON NX3 Elite diagnostic ultrasound system

Features and options unique to an ultrasound system are identified in Chapter 1 and Appendix A of the Instructions for Use. The user and reference manuals consist of the following publications. Publication

Includes

Instructions for Use

 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*

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

System Reference*

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

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

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

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

Instructions for Use

iii

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

WARNING: Warnings are intended to alert you to the importance of following the correct operating procedures where risk of injury to the patient or system user exists. Caution: Cautions are intended to alert you to the importance of following correct operating procedures to prevent the risk of damage to the system. Note: Notes contain information concerning the proper use of the system and/or correct execution of a procedure.

Cross-References

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

Customizable System Settings

System settings available for customization are depicted as shown. Example: Default Settings > Automatic Freeze Response

Keys and Controls

Keys and controls located on the control panel are identified by uppercase, boldface type. Example: Rotate the 2D control. Keys located on the keyboard are identified by boldface type. Example: Press the Exam key.

iv

Instructions for Use

On-screen Objects

On-screen objects such as menu selections, soft key selections, and buttons are identified by boldface type. Example: The system displays the Patient Registration form.

Selection of On-screen Objects

The SET key on the control panel functions as a point-and-select device (similar to a computer mouse) when used with the trackball. "Select" or "click" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press the SET key. "Double-click" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press the SET key twice. "Drag" describes this action: Roll the trackball to position the pointer (cursor) on an on-screen object and then press and hold the SET key. Roll the trackball to reposition the object and then release the SET key.

Touch Screen Controls

Tap the touch screen to make a soft key selection or to change a setting. Examples: Select 2D. Tap 2D. The touch screen has unlabeled controls located on the control panel. Press, rotate, or press and then rotate the controls to make a selection or change a setting. Within procedures in the user manual, the selection assigned to these controls are indicated in boldface type within brackets. Examples: Press and then rotate [Map] to select a color map.

Instructions for Use

v

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

Interaction with Ultrasound Equipment

Expected Experience and Other Characteristics

Sonographer

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

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

 Performs measurements and analysis of the acquired images  Prepares exam data for review and interpretation by a qualified physician

Cardiologist

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

Maternal-fetal Medicine Obstetrician/ Perinatologist Radiologist and Internist

 Many sonographers have a Bachelor's degree; some have advanced degrees in related health care subjects  Medical doctor  Expert in diagnostic imaging, including computed tomography (CT), magnetic resonance imaging (MRI), X-ray, ultrasound, and nuclear medicine  Advanced training in imaging physics with typically four to six years of post-doctoral training in the field of cardiology

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

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

 Writes and assembles exam findings in a report

 Skilled in interpreting ultrasound exam data

 Performs ultrasound exams

 Medical doctors

 Interprets exam data

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

 Writes and assembles exam findings in a report

System Administrator and Customer Service Engineer

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

 Configures the ultrasound system for use in a networked environment

 Advanced training in imaging physics with typically two to six years of post-doctoral training in the field of radiology  A System Administrator is an individual within your organization who is designated to set up system parameters to connect the ultrasound system or workstation to a picture archiving and communication system (PACS).  Customer Service Engineers are Siemens representatives who configure the ultrasound system or workstation during software installation and support troubleshooting activities.

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Instructions for Use

1 Introduction System Overview ... 3 System Review ... 4 Intended Use ... 6 ACUSON NX3 Ultrasound System ... 6 Indications for Use Statement ... 7 ACUSON NX3 Elite Ultrasound System ... 8 Indications for Use Statement ... 9 Transducers and Intended Applications ... 10 Image Screen Layout... 14 Screen Saver ... 14 Sample Image Screens ... 15 Sample Layout for 2D/M-Mode ... 16 Sample Layout for 2D-Mode with Color ... 17 Sample Layout for 2D-Mode with Doppler ... 18 Status Bar ... 19 User-Defined System Settings ... 19 QuickSet User-Programmable System Parameters ... 19

Instructions for Use

1 - 1

1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON NX3 and ACUSON NX3 Elite 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

1 Introduction

System Review

Example of the ultrasound system, front view. 1 User-adjustable monitor 2 Rear handle 3 Speakers 4 Shelf for optional documentation device 5 Transducer Holder 6 Printer 7 Transducer ports 8 Wheel with brake 9 Transducer port for continuous wave (pencil) transducers 10 Front handle 11 Backlit control panel with an alphanumeric keyboard and touch screen 12 Power On/Off (Standby) control ( )

1 - 4

Instructions for Use

1 Introduction

Example of the ultrasound system, back view. 1 Monitor 2 Articulating arm 3 Gel warmer (option) 4 CD/DVD read/write drive 5 Physio module with connectors for ECG and auxiliary input 6 Side storage bin 7 Power panel with circuit breaker 8 Input/output panel 9 Power cable hanger 10 Transducer cable hanger

Instructions for Use

1 - 5

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. Note: The ultrasound system is not intended for ophthalmic use.

ACUSON NX3 Ultrasound System The ACUSON NX3 ultrasound system supports the following applications: 

Abdomen



Breast



Cardiac



Cerebrovascular



Early Obstetrics



Emergency Medicine



Fetal Echo



Gynecology



Musculoskeletal



Obstetrics



Obstetrics (Japan)



Orthopedic



Pelvic Floor



Peripheral vascular



Renal



Small Parts



Testicle



Thyroid



Transcranial



Urology



Venous

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Instructions for Use

1 Introduction

Indications for Use Statement Product

Indications for Use Statement

ACUSON NX3 Ultrasound System

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used 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.

Instructions for Use

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1 Introduction

ACUSON NX3 Elite Ultrasound System The ACUSON NX3 Elite 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



Testicle



Thyroid



Transcranial



Urology



Venous

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Instructions for Use

1 Introduction

Indications for Use Statement Product

Indications for Use Statement

ACUSON NX3 Elite Ultrasound System

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used 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 the 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

Instructions for Use

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1 Introduction

Transducers and Intended Applications Refer to the following table for transducers compatible with these ultrasound systems: 

ACUSON NX3 ultrasound system



ACUSON NX3 Elite ultrasound system

Only the following transducers from Siemens are compatible with your ultrasound imaging system. EMC Note: Operating the transducer in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations may lead to temporary degradation or interference visible on the monitor screen. A lightening of image background may be noticed while visualizing hypoechoic structures, or color spectral interference, or jitter, or horizontal lines in the image screen may occur. The transducer and the system have been designed and tested to withstand such interference and will not be permanently damaged. See Also: Electromagnetic Emissions and Immunity Guidance and Manufacturer's Declaration Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

Exam Types on the System

Curved and Linear Array Transducers (Available on the ACUSON NX3 system and the ACUSON NX3 Elite system) CH5-2

VF10-5

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 Abdomen

 Abdomen

2.5 MHz–5.0 MHz

 Early Obstetrics

 Early OB

Doppler:

 Emergency Medicine

 EM

2.0 MHz–2.7 MHz

 Fetal Echo

 Fetal Echo

2D-mode:

2D, C, D, M

 Gynecology

 GYN

 Obstetrics

 OB

 Obstetrics (Japan)

 OB (J)

 Peripheral Vascular

 P-Vascular

 Renal

 Renal

 Urology

 Urology

 Venous

 Venous

 Breast

 Breast

6.2 MHz–10.0 MHz

 Cerebrovascular

 C-Vascular

Doppler:

 Emergency Medicine

 EM

4.0 MHz–6.2 MHz

 Musculoskeletal

 MSK

 Orthopedics

 Orthopedics

 Peripheral Vascular

 P-Vascular

 Testicle

 Testicle

2D-mode:

2D, C, D, M

 Thyroid

 Thyroid

 Venous

 Venous

Instructions for Use

1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

Exam Types on the System

VF12-4

2D-mode:

2D, C, D, M

 Breast

 Breast

6.2 MHz–11.4 MHz

 Cerebrovascular

 C-Vascular

Doppler:

 Emergency Medicine

 EM

4.0 MHz–6.7 MHz

 Musculoskeletal

 MSK

 Orthopedic

 Orthopedics

 Peripheral Vascular

 P-Vascular

 Small Parts

 Small Parts

 Testicle

 Testicle

 Thyroid

 Thyroid

 Venous

 Venous

Curved and Linear Array Transducers (Available only on the ACUSON NX3 Elite system) C8-5

VF13-5sp

 Cerebrovascular

 C-Vascular

4.2 MHz–8.4 MHz

 Neonatal Head

 Neo Head

Doppler:

 Pediatric Abdomen

 Ped Abdomen

4.2 MHz–5.0 MHz

 Pediatric Echo

 Ped Echo

2D-mode:

2D, C, D, M

 Musculoskeletal

 MSK

7.3 MHz–11.4 MHz

 Small Parts

 Small Parts

Doppler:

 Cerebrovascular

 C-Vascular

2D-mode:

2D, C, D, M

6.2 MHz–7.3 MHz VF16-5

2D-mode:

2D, C, D, M

 Venous

 Venous

 Breast

 Breast

8.0 MHz–13.3 MHz

 Cerebrovascular

 C-Vascular

Doppler:

 Emergency Medicine

 EM

5.3 MHz–6.2 MHz

 Penile

 Penile

 Superficial Musculoskeletal

 Sup MSK

 Testicle

 Testicle

 Thyroid

 Thyroid

Phased Array Transducers (Available on the ACUSON NX3 system and the ACUSON NX3 Elite system) P4-2

 Abdomen

 Abdomen

 Cardiac

 Cardiac

Doppler:

 Emergency Medicine

 EM

2.0 MHz–3.3 MHz

 Gynecology

 GYN

 Obstetrics

 OB

 Obstetrics (Japan)

 OB (J)

 Renal

 Renal

 Transcranial

 TCD

2D-mode: 2.0 MHz–4.0 MHz

Instructions for Use

2D, C, D, M, SCW

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1 Introduction

Transducer Name

Operating Frequency1

Modes of Operation2

Intended Applications

Exam Types on the System

Phased Array Transducers (Available only on the ACUSON NX3 Elite system) P8-4

2D-mode: 3.8 MHz–6.7 MHz

2D, C, D, M, SCW

Doppler: 3.6 MHz–4.4 MHz

 Neonatal Head

 Neo Head

 Pediatric Abdomen

 Ped Abdomen

 Pediatric Echo

 Ped Echo

 Renal

 Renal

Endocavity Transducers (Available on the ACUSON NX3 system and the ACUSON NX3 Elite system) EC9-4

 Early Obstetrics

 Early OB

5.0 MHz–9.4 MHz

 Gynecology

 GYN

Doppler:

 Obstetrics

 OB

4.0 MHz–6.2 MHz

 Obstetrics (Japan)

 OB (J)

 Urology

 Urology

2D, C, D, M

2D-mode:

Endocavity Transducers (Available only on the ACUSON NX3 Elite system) EC10-5w

 Early Obstetrics

 Early OB

5.7 MHz–10.0 MHz

 Gynecology

 GYN

Doppler:

 Obstetrics

 OB

4.2 MHz–5.3 MHz

 Obstetrics (Japan)

 OB (J)

 Urology

 Urology

2D, C, D, M

2D-mode:

fourSight 4D Transducers (Available on the ACUSON NX3 system and the ACUSON NX3 Elite system) C8F3

 Abdomen

 Abdomen

3.3 MHz–5.7 MHz

 Early Obstetrics

 Early OB

Doppler:

 Fetal Echo

 Fetal Echo

2.7 MHz–3.3 MHz

 Gynecology

 GYN

 Obstetrics

 OB

 Obstetrics (Japan)

 OB (J)

 Pelvic Floor

 Pelvic Floor

2D, C, D, M

2D-mode:

Continuous Wave Transducers (Available only on the ACUSON NX3 Elite system) CW2 CW5

1 - 12

2 MHz 5 MHz

CW CW

 Cardiac

 Cardiac

 Pediatric Echo

 Ped Echo

 Cerebrovascular

 C-Vascular

 Pediatric Echo

 Ped Echo

Instructions for Use