ACUSON P500 and P500 ICE Instructions for Use Sw Ver VC11

Product Version 3.1 Software Version VC11 ©2015-2024 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2024-01 The following trademarks are owned by: Siemens Medical Solutions USA, Inc. AcuNav, AcuNav CRYSTAL, ACUSON, ACUSON AcuNav, ACUSON P500, Advanced SieClear, Clarify, DTI, Dynamic TCE, eSie Measure, eSieScan, fourSight, microCase, MultiHertz, SieClear, SieScape, SuppleFlex, SwiftLink, TEQ, Velocity Vector Imaging 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. The user documentation includes references to third-party products for informational purposes only. These references do not represent an endorsement of the third-party products referenced in the user documentation or an assumption of responsibility for the performance of third-party products. Siemens Medical Solutions USA, Inc. reserves the right to change its products and services at any time. In addition, this publication is subject to change without notice. Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 22010 S.E. 51st Street Issaquah, WA 98029 U.S.A. Phone: +1-888-826-9702 siemens-healthineers.com

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

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 preventing unauthorized access to the ultrasound system; 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.

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

Cybersecurity Information about ultrasound system security.

Appendix D

Acoustic Output Reference Acoustic output reporting tables.

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

Instructions for Use

i

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

ACUSON P500 diagnostic ultrasound system



ACUSON P500 ICE diagnostic ultrasound system

Features and options unique to an ultrasound system are identified within the following locations in the user and reference manuals: 

Chapter 1, Instructions for Use



Appendix A, 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 system controls  Procedures for system setup, examination fundamentals, image acquisition and optimization, and examination review  Information about system security and protection of patient data against security threats  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  Description of the transesophageal transducer, including cleaning and care of the transducer  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.

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Instructions for Use

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.

Instructions for Use

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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.

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Instructions for Use

1 Introduction System Overview ... 3 Intended Use ... 5 Indications for Use Statement... 5 Operating Modes ... 6 Patient Target Groups ... 6 Intended Use Environment ... 6 Intended Users ... 7 Contraindications... 7 Transducers and Intended Applications ... 8 Legend ... 11 Principles of Operation ... 12 Clinical Benefits ... 12 About the Image Screen with Touch Technology ... 13 Soft Keys on the Touch Screen ... 15 Left Panel Controls on the Touch Screen ... 16 Controls during General Imaging... 16 Controls for the Measurement Function ... 17 System Status Indicators ... 18 About the Control Panel... 19 Control Panel Lighting ... 20 Power Control ... 20 Touchpad... 21 Touchpad Keys ... 21 Workflow Controls ... 22 Operating Mode Controls... 23 Soft Key Controls... 23 Image Acquisition and Documentation Controls ... 24 Optimization Controls ... 25 Alphanumeric Keyboard ... 26 Shortcut Keys ... 26 System Configuration ... 27

Instructions for Use

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1 Introduction

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Instructions for Use

1 Introduction

System Overview The ACUSON P500 and ACUSON P500 ICE (Intracardiac Echocardiography) ultrasound systems are hand-carried, workflow-driven systems designed for intracardiac imaging as well as general imaging and emergency medicine applications where portability and minimal manual optimization are required. See also: For a technical description of the ultrasound system, refer to Appendix A in this manual.

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. WARNING: To avoid the risk of human injury and permanent damage to the ultrasound system, do not use the ultrasound system, transducers, or ultrasound components and accessories during magnetic resonance imaging (MRI) or in an environment with magnetic resonance (MR) equipment. WARNING: The ultrasound system is not intended for ophthalmic use. Caution: In the United States of America, federal law restricts this device to sale or use by, or on the order of, a physician. 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.

Indications for Use Statement Product

Indications for Use Statement

ACUSON P500 Ultrasound System

The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Intracardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures 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.

ACUSON P500 ICE Ultrasound System

The ACUSON P500 ICE ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Intracardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures 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 the state of their cardiovascular system.

*Note: 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."

Instructions for Use

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1 Introduction

Operating Modes (Available on the ACUSON P500 and ACUSON P500 ICE systems) 

2D-mode –









2D-mode with Harmonics imaging

Color flow Doppler –

Color (velocity)1

–

Power (energy)2

–

Doppler Tissue Imaging

Pulsed Wave Doppler –

Pulsed Wave Doppler Tissue Imaging

–

High Pulsed Repetition Frequency Pulsed Wave Doppler

Continuous Wave Doppler –

Steerable Continuous Wave Doppler for phased array transducers

–

Auxiliary Continuous Wave Doppler for pencil transducers

M-mode –

M-mode with Harmonics imaging

–

Anatomical M-mode

Color is also known as Color Doppler Velocity (CDV).

1

Power is also known as Color Doppler Energy (CDE).

2

Combined Modes 

2D-mode with color



2D-mode with power



2D/Doppler



2D/Doppler with color



2D/Doppler with power



2D/M-mode



2D/Anatomical M-mode

Patient Target Groups 

Adult



Pediatric



Fetal

Intended Use Environment The ultrasound system is a portable device intended for use in clinical environments, such as hospitals, clinics, or medical offices. See also: For information about the environmental requirements, refer to Appendix A in this manual.

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Instructions for Use

1 Introduction

Intended Users User

Interaction with Ultrasound Equipment

Sonographer

 Acquires diagnostic views of anatomy, blood flow, and related pathology  Performs measurements and analysis of the acquired images

Physician

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

 Performs ultrasound exams

 Medical doctor

 Interprets exam data

 Trained in ultrasound imaging techniques

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

 Skilled in interpreting ultrasound exam data

 Performs ultrasound exams

 Medical doctor

 Performs image-guided access and biopsy procedures

 Expert in diagnostic imaging, including computer tomography, magnetic resonance imaging, X-ray, ultrasound, and nuclear medicine

 Interprets exam data  Writes and assembles exam findings in a report

System Administrator and Customer Service Engineer

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

 Prepares exam data for review and interpretation by a qualified physician

 Writes and assembles exam findings in a report Radiologist

Expected Experience and Other Characteristics

 Configures the ultrasound system for use in a networked environment

 Advanced training in imaging physics with typically two to six years of postdoctoral training in the field of radiology; some specialize in diagnostic ultrasound  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).  A customer service engineer is an individual representing the manufacturer of the ultrasound system who configures the ultrasound system during initial installation, supports troubleshooting activities, and repairs the system.

Contraindications There are no known contraindications for diagnostic ultrasound.

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1 Introduction

Transducers and Intended Applications WARNING: The ultrasound system is not intended to be used with high-frequency surgical equipment. Use of transducers in conjunction with high-frequency surgical equipment may result in an increased risk of harm to the patient in the event of a defect in the high-frequency surgical neutral electrode connection.

Only the following transducers are compatible with ACUSON P500 and ACUSON P500 ICE ultrasound systems. Transducer Name

Modes of Operation1

Intended Applications

Exam Types on the System

Curved and Linear Array Transducers CH5-2

VF10-5

VF13-5

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2D, C, D, M

2D, C, D, M

2D, C, D, M

 Obstetrics

 OB

 Early Obstetrics

 Early OB

 Gynecology

 GYN

 Abdomen

 Abdomen

 Renal

 Renal

 Pelvis

 Pelvis

 Emergency Medicine

 EM

 Lung

 Lung

 Focused Assessment with Sonography for Trauma

 FAST

 Thyroid

 Small Parts

 Testicle

 Small Parts

 Breast

 Breast

 Musculoskeletal

 MSK

 Cerebrovascular

 CV

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

 Emergency Medicine

 EM

 Lung

 Lung

 Thyroid

 Small Parts

 Testicle

 Small Parts

 Breast

 Breast

 Musculoskeletal

 MSK

 Cerebrovascular

 CV

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

 Emergency Medicine

 EM

Instructions for Use

1 Introduction

Transducer Name

Modes of Operation1

Intended Applications

Exam Types on the System

Curved and Linear Array Transducers VF16-5

2D, C, D, M

L10-5v

2D, C, D, M

11M3

2D, C, D, M M3 11

18H5

2D, C, D, M

 Breast

 Breast

 Cerebrovascular

 CV

 Emergency Medicine

 EM

 Testicle

 Small Parts

 Thyroid

 Small Parts

 Musculoskeletal

 MSK

 Superficial Musculoskeletal

 Sup MSK

 Breast

 Breast

 Cerebrovascular

 CV

 Testicle

 Small Parts

 Thyroid

 Small Parts

 Musculoskeletal

 MSK

 Emergency Medicine

 EM

 Peripheral Vascular

 PV-Arterial

 Venous

 PV-Venous

 Lung

 Lung

 Cerebrovascular

 CV

 Neonatal Head

 Neo Head

 Pediatric Abdomen

 Ped Abd

 Pediatric Echo

 Ped Echo

 Cerebrovascular

 CV

 Venous

 PV-Venous

 Superficial Musculoskeletal

 Sup MSK

Phased Array Transducers P4-2

P8-4

Instructions for Use

2D, C, D, M, CW

2D, C, D, M, CW

 Obstetrics

 OB

 Abdomen

 Abdomen

 Emergency Medicine

 EM

 Cardiac

 Cardiac

 Lung

 Lung

 Transcranial Doppler

 TCD

 Focused Assessment with Sonography for Trauma

 FAST

 Neonatal Head

 Neo Head

 Pediatric Abdomen

 Ped Abd

 Pediatric Echo

 Ped Echo

 Renal

 Renal

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1 Introduction

Transducer Name

Modes of Operation1

Intended Applications

Exam Types on the System

Phased Array Transducers 5VT

2D, C, D, M, CW

 Transesophageal

 TEE

AcuNav 8F/ SOUNDSTAR eco 8F

2D, C, D, M, CW

 Intracardiac

 Intracardiac

AcuNav 10F/ SOUNDSTAR 10F/ SOUNDSTAR eco 10F

2D, C, D, M, CW

 Intracardiac

 Intracardiac

AcuNav CRYSTAL/ SOUNDSTAR CRYSTAL

2D, C, D, M, CW

 Intracardiac

 Intracardiac

Endocavity Transducers EC9-4

2D, C, D, M

 Obstetrics

 OB

 Early Obstetrics

 Early OB

 Gynecology

 GYN

 Emergency Medicine

 EM

Continuous Wave Transducers CW2

CW5

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CW

CW

 Cardiac

 Cardiac

 Pediatric Echo

 Ped Echo

 Cerebrovascular

 CV

 Pediatric Echo

 Ped Echo

Instructions for Use

1 Introduction

Legend Modes of Operation

Includes one or more of the following system operating modes:

2D (brightness mode)

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

C (color flow Doppler)

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

D (Doppler)

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

M (motion mode)

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

CW (continuous wave Doppler)

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

1

Doppler Tissue Imaging (DTI), Doppler Tissue Energy (DTE)

Instructions for Use

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1 Introduction

Principles of Operation Diagnostic ultrasound uses high-frequency (above the audible range) sound waves to produce an image of anatomical structures within the body. Electrical pulses vibrate ceramics within a transducer to transmit the sound waves into the body. Sound waves travel through body tissue at approximately 1,540 meters per second and reflect back as echoes to the transducer at each point of change in tissue density, for example, at the border of two organs in the body. These return signals provide information about the acoustic properties of the tissue. The time to receive the echo in microseconds indicates a distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image.

Clinical Benefits Ultrasound has a positive impact on the health of an individual as a non-ionizing diagnostic imaging tool. The device provides real-time anatomic and kinetic visualization of internal organs, tissue structures, blood flow, and Doppler-enabled hemodynamics. Ultrasound is the accepted imaging modality for the safe visualization of fetal anatomy and monitoring of fetal development. The mobility and cost effectiveness of ultrasound increases access to patients in clinical environments. Patient benefits also include a safer examination compared to imaging modalities using ionizing radiation. Real-time ultrasound imaging provides guidance during interventional procedures, for example, needle biopsies and fluid aspirations; in the absence of ultrasound, these procedures are conducted without visualization or with ionizing radiation.

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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. A user name and password are required to exit the screen saver and access the system.

ACUSON P500

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