ACUSON P500 Instructions for Use Sw Ver VB10

Product Version 2.0

CE Declaration

Software Version VB10

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.

©2015-2017 Siemens Medical Solutions USA, Inc. All Rights Reserved. February 2017 Printed in the Republic of Korea. ACUSON P500, AcuNav, Advanced SieClear, Clarify, Dynamic TCE, DTI, eSie Measure, eSieScan, microCase, MultiHertz, SuppleFlex, Siemens, SieClear, SieScape, SwiftLink, TEQ, and THI are trademarks of Siemens Medical Solutions USA, Inc. syngo is a trademark of Siemens Healthcare GmbH. All other product names are references to third-party products and are trademarks of their respective companies. Siemens includes references to third-party products in the user documentation for informational purposes only. Siemens does not endorse third-party products referenced in the user documentation. Siemens does not assume responsibility for the performance of third-party products.

Unauthorized changes to this product are not covered by the CE marking and the related Declaration of Conformity. EU Authorized Representative Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany

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

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

Contents Chapter 1

Introduction Overview of the diagnostic ultrasound imaging system, intended use, and a detailed description of the touch screen and control panel.

Chapter 2

Safety and Care Detailed information on system safety and care for the ultrasound system.

Chapter 3

System Setup Detailed descriptions for setting up and transporting the system. Includes procedures for updating your system software.

Chapter 4

Examination Fundamentals Procedures for registering a patient; selecting a transducer, exam type and operating mode; and optimizing and capturing images. Includes procedures for creating and editing user-defined exam types.

Chapter 5

Examination Review Procedures for reviewing images and clips in the current or previous examination.

Chapter 6

Transducer Care and Accessories Detailed information on transducer safety, cleaning and disinfecting, and transducer accessories. Attachment procedures for transducer accessories.

Instructions for Use

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Appendix A

Technical Description Technical description of the ultrasound system, including the operating and storage temperatures for the transducers and system.

Appendix B

Patient Data General description of the patient registration form and the patient browser.

Appendix C Appendix D

Reserved for Future Use 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 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 system controls  Procedures for system setup, examination fundamentals, image acquisition and optimization, and examination review  Acoustic output data

Clinical Applications Guide

 Explanation of clinical applications and clinical software programs for use on the ultrasound system  Procedures for the physiologic function and the biopsy function  General and exam-specific measurements and calculations  Exam-specific annotations

System Reference*

 General and exam-specific measurement and calculation labels  Data management  Description of customizable system settings  Information about DICOM connectivity and network capabilities  Clinical references  Information regarding the electromagnetic compatibility (EMC) testing of this system

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

Instructions for Use

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Conventions Take a moment to familiarize yourself with the following conventions in your user manual. Convention Warnings, Cautions, and Notes

Description 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.

Examples of Cross-References

See also: For additional information, refer to Chapter 2 in the System Reference manual. See also: Touch screen controls, p. 1-17 See also: For a list of transducers compatible with the needle guide accessories, refer to Chapter 5 in this manual.

Selection of On-screen Objects

Many functions on the system support interaction with the control panel, the touchpad, and the touch screen. Procedures throughout the user and reference manuals describe only one method. "Press" describes the action of pressing a control on the control panel, including the touchpad keys. "Tap" describes the action of tapping the touchpad or the touch screen. "Select" describes the action of highlighting an on-screen object, making a selection from a list, or enabling an on-screen selection. You can typically select objects using either the touchpad or the touch screen. "Click" describes the action of using the touchpad to position the pointer on an on-screen control or object and then either pressing the left or right touchpad key or tapping the touchpad. Examples:  Click Cancel to close the patient registration form.  Click an image in the thumbnail panel.

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Instructions for Use

Typographical Conventions The following typographical conventions are in descriptions and procedures within your user manual. You can use these conventions to identify the location of a control or selection on the ultrasound system. Control or Selection

Convention

Controls on the Control Panel and Keys on the Keyboard

Controls on the control panel are identified by uppercase, boldface type. Examples:  Rotate 2D.  Press FREEZE.  Press ARROW on the keyboard.  Press PATIENT.

Touchpad Keys on the Control Panel

The touchpad keys are on either side of the touchpad or above the touchpad. Touchpad keys correspond to selections on the touch screen and are identified by boldface type. Example:  Press the Update touchpad key.

Soft Key Selections on the Touch Screen and Control Panel

Soft key selections are on the bottom of the touch screen. To access the selection, you can tap the touch screen or press the corresponding control at the top of the control panel. These selections are identified by boldface type and enclosed in square brackets ([ ]). Examples:  Tap [MultiHertz] and then tap the required setting.  Press [Tx Power] downward to decrease transmit power.

Left or Right Panel Controls on the Touch Screen

Left or right panel controls are on the left or right side of the touch screen and are identified by boldface type. Example:  Tap Color Display in the left panel.

Software Selections

Software selections are identified by boldface type. Examples:  Click Cancel.  Click OK.

Instructions for Use

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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

Radiologist and Internist

 Medical doctors  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  Medical doctors

 Interprets exam data

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

 Performs rapid assessment, treatment, and clinical stabilization of acutely ill patients before admitting the patients for further diagnosis and treatment or discharge  Performs and interprets examinations, but have limited time to complete exams

Anesthesiologist

 Many sonographers have a Bachelor's degree; some have advanced degrees in related health care subjects

 Performs ultrasound exams  Writes and assembles exam findings in a report

Emergency Medicine Physician

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

 Uses ultrasound as a tool to guide nerve blocks, primary anesthesia, and vascular access procedures

 Advanced training in imaging physics with typically two to six years of post-doctoral training in the field of radiology  Medical doctors  Varying range of ultrasound imaging experience  Typically trained in limited ultrasound examinations and Focused Assessment with Sonography for Trauma (FAST) techniques

 Medical doctors  Focused on managing patient pain during and after surgical procedures  Minimally trained in ultrasound and use ultrasound as a tool to guide procedures

Rheumatologist

 Diagnoses and treats musculoskeletal conditions  Performs musculoskeletal ultrasound exams  Performs injections under ultrasound guidance

 Medical doctors  Focused on treating conditions that affect the musculoskeletal system  Minimally trained in ultrasound and use many tools in addition to ultrasound in their practice

System Administrator

 Configures the ultrasound system for use in a networked environment

 A System Administrator is an individual within your organization who is designated to set up system parameters to connect the ultrasound system to a picture archiving and communication system (PACS).

Customer Service Engineer or Biomedical Engineer

 Installs and configures software

 Customer Service Engineers are Siemens representatives or your Biomedical Engineer trained by Siemens to configure the ultrasound system during software installation and support troubleshooting activities.

vi

 Troubleshoots system hardware and software

Instructions for Use

1 Introduction System Overview ... 3 Intended Use ... 5 Contraindications ... 5 Indications for Use Statement... 5 Transducers and Intended Applications ... 6 About the Image Screen with Touch Technology ... 9 Soft Keys on the Touch Screen ... 11 Left Panel Controls on the Touch Screen ... 12 Controls during General Imaging... 12 Controls for the Measurement Function ... 13 System Status Indicators ... 14 About the Control Panel... 15 Control Panel Lighting ... 16 Power Control ... 16 Touchpad... 17 Touchpad Keys ... 17 Workflow Controls ... 18 Operating Mode Controls... 19 Soft Key Controls... 19 Image Acquisition and Documentation Controls ... 20 Doppler Optimization Controls ... 21 Alphanumeric Keyboard ... 22 Shortcut Keys ... 22 System Configuration ... 23

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON P500 ultrasound system is a hand-carried, workflow-driven system designed for general imaging and emergency medicine applications where portability and minimal manual optimization are required. The ultrasound system supports the following operating modes: 

2D-mode



2D-mode with Tissue Harmonic Imaging (THI)



2D/M-mode



Pulsed Wave Doppler



Steerable Continuous Wave Doppler (for phased array transducers)



Auxiliary Continuous Wave Doppler (for pencil transducers)



Color Doppler Energy (CDE)



Color Doppler Velocity (CDV)



Doppler Tissue Energy (DTE)



Doppler Tissue Imaging (DTI)



Dual mode

Instructions for Use

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1 Introduction

Example of the ultrasound system. 1 Touch screen monitor 2 Control panel and alphanumeric keyboard 3 ECG connector 4 Transducer release lever 5 Transducer port 6 Speakers 7 Battery indicator 8 USB ports 9 HDMI connection for an external VGA monitor 10 Ethernet connection 11 Power on/off

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Instructions for Use

1 Introduction

Intended Use WARNING: The analysis of results from an ultrasound examination requires that you are trained in the interpretation of diagnostic ultrasound studies and are qualified to make clinical diagnoses. Caution: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician. Caution: Ultrasound is used as an imaging aid, but may have further restrictions specific to invitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

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

Indications for Use Statement Product

Indications for Use Statement

ACUSON P500 Ultrasound System

The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Pelvic, Neonatal, Cardiac, Intracardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial)} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

syngo Arterial Health Package (AHP)

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."

ACUSON ACUNAV Ultrasound System

Instructions for Use

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.

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1 Introduction

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

Operating Frequency 1

CH5-2

2D-mode:

Modes of Operation 2

Intended Applications

Exam Types on the System

Curved and Linear Array Transducers

VF10-5

VF13-5

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 Obstetrics

 OB

2.5-5.0 MHz

 Early Obstetrics

 Early OB

Doppler:

 Gynecology

 GYN

2.0-3.3 MHz

 Abdomen

 Abdomen

 Renal

 Renal

2D, C, D, M

 Pelvis

 Pelvis

 Emergency Medicine

 EM

 Thyroid

 Small Parts

6.2-10.0 MHz

 Testicle

 Small Parts

Doppler:

 Breast

 Breast

4.0-6.2 MHz

 Musculoskeletal

 MSK

 Cerebrovascular

 CV

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

 Emergency Medicine

 EM

 Thyroid

 Small Parts

7.3-12.0 MHz

 Testicle

 Small Parts

Doppler:

 Breast

 Breast

4.7-7.3 MHz

 Musculoskeletal

 MSK

 Cerebrovascular

 CV

2D-mode:

2D-mode:

2D, C, D, M

2D, C, D, M

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

 Emergency Medicine

 EM

Instructions for Use

1 Introduction

Transducer Name

Operating Frequency 1

Modes of Operation 2

Intended Applications

Exam Types on the System

VF16-5

2D-mode:

2D, C, D, M

L10-5v

 Breast

 Breast

8.0-15.0 MHz

 Cerebrovascular

 CV

Doppler:

 Emergency Medicine

 EM

5.3-6.2 MHz

 Testicle

 Small Parts

 Thyroid

 Small Parts

 Musculoskeletal

 MSK

 Superficial Musculoskeletal

 Super MSK

 Breast

 Breast

2D-mode:

2D, C, D, M

6.2-10.0 MHz

 Cerebrovascular

 CV

Doppler:

 Testicle

 Small Parts

4.0-6.2 MHz

 Thyroid

 Small Parts

 Musculoskeletal

 MSK

 Emergency Medicine

 EM

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

Phased Array Transducers P4-2

P8-4

AcuNav 8F/ SoundStar eco 8F

2D-mode:

2D, C, D, M, CW

 Obstetrics

 OB

2.5-4.0 MHz

 Abdomen

 Abdomen

Doppler:

 Emergency Medicine

 EM

2.0-3.3 MHz

 Cardiac

 Cardiac

 Neonatal Head

 Neo Head

4.2-7.2 MHz

 Pediatric Abdomen

 Ped Abd

Doppler:

 Pediatric Echo

 Ped Echo

3.6-4.4 MHz

 Renal

 Renal

2D, C, D, M, CW

 Intracardiac

 Intracardiac

2D, C, D, M, CW

 Intracardiac

 Intracardiac

2D-mode:

2D-mode:

2D, C, D, M, CW

5.0-8.0 MHz Doppler: 3.6-4.4 MHz

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

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

Instructions for Use

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1 Introduction

Transducer Name

Operating Frequency 1

Modes of Operation 2

EC9-4

2D-mode:

2D, C, D, M

Intended Applications

Exam Types on the System

Endocavity Transducers  Obstetrics

 OB

 Early Obstetrics

 Early OB

Doppler:

 Gynecology

 GYN

4.0-6.2 MHz

 Emergency Medicine

 EM

5.0-9.4 MHz

Continuous Wave Transducers CW2

CW5

1

2.0 MHz

5.0 MHz

Operating Frequency

CW

CW

 Cardiac

 Cardiac

 Pediatric Echo

 Ped Echo

 Cerebrovascular

 CV

 Pediatric Echo

 Ped Echo

Range of selectable operating frequencies:

2D-mode

Fundamental and harmonic imaging, not including contrast

Doppler

Pulsed wave, continuous wave, and color imaging

2

Modes of Operation

Includes one or more of the following system operating modes:

2D (brightness mode)

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

C (color flow Doppler)

Color Doppler Velocity (CDV), Color Doppler Energy (CDE), Doppler Tissue Imaging (DTI), Doppler Tissue Energy (DTE)

D (Doppler)

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

M (motion mode)

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

CW (continuous wave Doppler)

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

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Instructions for Use

1 Introduction

About the Image Screen with Touch Technology During real-time imaging, the screen displays clinical images, operating parameters, patient data, and controls. Use the configuration settings to customize the screen elements to accommodate your preferences and workflow. The screen supports touch technology for selecting options during real-time imaging. For example, you can select options and settings by tapping the required control on the screen. Note: During real-time imaging, the screen area with the image does not support touch technology. During review, the entire screen supports touch technology.

The screen saver feature freezes the system and replaces the active display with a screen saver after the system has been inactive for a specified number of minutes. Exit the active screen saver by pressing any key, adjusting any control, or tapping the touchpad.

Example of a typical image screen. 1

2 3

Mode indicators Displays the activated operating modes and highlights the indicator for the priority mode. Tap the required mode indicator to change the active priority mode. Patient banner Displays patient information and the system date and time. System status bar Displays information about the system, for example, wireless connectivity and battery life.

Instructions for Use

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1 Introduction

4

Right panel Displays reference images of stored images and clips or provides functions for workflow protocols such as eSieScan or Stress Echo. Swipe upwards or downwards on the thumbnail panel to view the images. During review, double-tap a thumbnail to display the image in a full-screen format. You can also tap thumbnails to add images to reports. 5 Soft keys Tap a soft key to display the available selections and then tap the required selection. During the measurement function, the soft keys display the measurement methods. 6 Touchpad legend Identifies the function assigned to the touchpad keys and gestures supported on the touchpad. When you view a patient report, the system displays the legend in the left panel. 7 Soft keys Tap a soft key to display the available selections and then tap the required selection. During the measurement function, the soft keys display the measurement methods. 8 Left panel controls Tap the control to activate and deactivate functions or to select the required setting. The left panel displays measurement labels during the measurement function and text or body markers during the annotation function. 9 Imaging parameters Displays a list of imaging settings for the active operating mode. 10 Transducer orientation indicator Indicates the direction of the scan

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Instructions for Use

1 Introduction

Soft Keys on the Touch Screen You can access the functions assigned to the soft keys using the touch screen or the control panel. Use the configuration settings to assign functions to the soft keys.

Example of 2D-mode soft keys at the bottom of the image screen. 1

2 3 4 5

6

Imaging parameters currently assigned to the soft keys Tap the required on-screen soft key or press the assigned soft key control on the control panel to change the setting for the imaging parameter. Imaging parameters currently assigned to the soft keys Next set of soft key assignments Tap the list to assign this set of parameters to the soft keys. On/off imaging parameter Tap the soft key or press the soft key control to activate or deactivate the parameter or function. Adjustable imaging parameters Tap the soft key to display the available settings for the parameter and then tap the selection. The current setting is displayed on the soft key. Previous set of soft key assignments Tap the list to assign this set of parameters to the soft keys.

Instructions for Use

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1 Introduction

Left Panel Controls on the Touch Screen You can access functions specific to the current operating mode or task using the selections in the left panel of the touch screen.

Controls during General Imaging

Example of Doppler selections in the left panel. 1

2 3

Multiple selections Tap the control to cycle through the available selections or display additional selections. The current selection is displayed on the control. Activated function An on/off selection displays this symbol when the function is activated. On/off selection Tap the control to activate or deactivate the function.

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Instructions for Use