ACUSON Maple and Maple Select Instructions for Use VA10

An updated User and Reference Manual may be available for your ultrasound system. Refer to your printed manual or access the most recent manual from the Siemens Healthineers Document Library at doclib.siemens-healthineers.com. Product Version 1.0 Software Version VA10 ©2023 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2023-10 The following trademarks are owned by Siemens Medical Solutions USA, Inc. (hereinafter "Siemens"): 3-Scape, ACUSON, ACUSON Maple, Advanced fourSight, Advanced SieClear, Clarify, DTI, Dynamic TCE, eSie Calcs, eSie Left Heart, eSie Measure, eSie Touch, eSieScan, fourSight, microCase, MultiHertz, SieClear, SieScape, SuppleFlex, 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. Siemens includes references to third-party products in the user documentation for informational purposes only. Siemens does not endorse third-party products referenced in the user documentation. Siemens does not assume responsibility for the performance of third-party products. Siemens reserves the right to change its products and services at any time. In addition, this publication is subject to change without notice. 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 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 Siemens Healthineers representative to determine the current availability of features and options.

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

ACUSON Maple diagnostic ultrasound system



ACUSON Maple Select 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



Chapter 3, Instructions for Use



Appendix A, Instructions for Use

The user and reference manuals consist of the following publications. Publication

Includes

Instructions for Use

 Conventions and typographical conventions used in the manuals  Intended audience  Introduction to the ultrasound system  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  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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Conventions Take a moment to familiarize yourself with the following conventions in your user manual. Convention Warnings and Cautions

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 the correct operating procedures to prevent the risk of damage to the ultrasound system.

Notes and Prerequisites

Prerequisite: Prerequisites contain tasks the user must complete or information the user needs prior to performing a procedure. Note: Notes contain information concerning the proper use of the ultrasound system or correct execution of a procedure.

Examples of Cross-References

Examples: See also: For additional information, refer to Chapter 2 in the System Reference manual. See also: Touch screen controls, page 1-17 See also: For a list of transducers compatible with the needle guide accessories, refer to Chapter 6 in this manual.

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Typographical Conventions The following typographical conventions are in descriptions and procedures within your user and reference manuals. Use the conventions to identify the location of a control or selection on the ultrasound system. Control or Selection

Description

Controls on the Control Panel and Keys on the Keyboard

Controls on the control panel are indicated by uppercase, boldface type. The function of the trackball and trackball keys is indicated by on-screen labels displayed on the image screen. Examples:  Push DEPTH / FOCUS.  Rotate 2D to adjust the 2D gain.  Press CALIPER to activate the measurement function.  Press and hold the Alt key on the keyboard to access the special characters.  Press UPDATE.  Position the marker and then press SET.

Controls on the Control Panel and Soft Key Selections on the Touch Screen

The touch screen has unlabeled controls located on the control panel. Tap, press, rotate, or press and then rotate the control to make a selection or change a setting. The selection assigned to these controls is indicated by boldface type and enclosed in square brackets ([ ]). Examples:  Press [Tx Power] downward to decrease transmit power.  Rotate [Map].

Selections on the Image Screen

On-screen selections are indicated by boldface type. Roll the trackball to position the pointer on the on-screen control or object and then press a trackball key. Examples:  Click Cancel.  Double-click a thumbnail.  Select the required check box to search for scheduled procedures.

Selections on the Touch Screen

On-screen selections are indicated by boldface type. To access the selection, tap the touch screen. To change the direction of an object displayed on the touch screen, drag the object on the touch screen. Examples:  Tap Stress Echo.  Drag the blue dot to indicate the direction of the arrow.  Swipe the page to select the next page.

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1 Introduction System Overview... 3 Intended Use ... 8 Indications for Use Statement ... 9 Operating Modes ... 10 Patient Target Groups... 10 Intended Use Environment ... 10 Intended Users ... 11 Contraindications ... 11 Transducers and Intended Applications ... 12 Curved and Linear Array Transducers ... 12 Phased Array Transducers... 16 Endocavity Transducers... 17 fourSight 4D Transducers ... 17 CW Transducers... 18 Legend ... 18 Principles of Operation ... 19 Clinical Benefits ... 19 Image Screen Layout... 20 Screen Saver ... 20 System Status Indicators ... 21 About the Control Panel ... 23 Control Panel Lighting... 24 Power Control ... 24 Workflow Controls ... 25 Operating Mode Controls ... 26 Image Acquisition and Documentation Controls ... 27 Optimization Controls... 28 Touch Screen Controls ... 29 Touch Screen Symbols ... 30 Touch Screen Keyboard ... 31 Special Keys and Special Characters ... 31 System Configuration ... 32

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System Overview The ACUSON Maple and ACUSON Maple Select ultrasound systems are designed for diagnostic use in general, vascular, and cardiac imaging. The system streamlines clinical workflow from patient registration to study archival with software-based applications, transducers, and clinical communication tools. See also: For a technical description of the ultrasound system, refer to Appendix A in this manual.

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Example of the ultrasound system, front view. 1 User-adjustable monitor 2 Gel warmer 3 Transducer ports for array transducers 4 Wheel 5 Transducer port for continuous wave (pencil) transducers 6 Retractable keyboard 7 Transducer cable hook 8 Transducer holder 9 Speaker 10 Touch screen 11 Task light

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Example of the ultrasound system, right view. 1 2 3 4 5 6 7

Printer CD/DVD drive Physio module Input/output panel door Power supply unit Touch screen brightness controls Monitor controls and task light control

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Example of the ultrasound system, left front view. 1 2 3 4 5

Storage bin Air filter Power on/off Side storage bin Touch screen with USB ports

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Example of the ultrasound system, back view. 1 2

Adjustable arm Power cord hook

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

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Indications for Use Statement Product

Indications for Use Statement

ACUSON Maple Ultrasound System

The ACUSON Maple 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: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

ACUSON Maple Select Ultrasound System

The ACUSON Maple Select 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: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic 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 Medicine."

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Operating Modes 

2D-mode –











2D-mode with Harmonic imaging

Color flow Doppler –

Color (velocity)

–

Power (energy)

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 Harmonic imaging

–

Anatomical M-mode

3D/4D Volume Imaging

Combined Modes 

2D-mode with Color



2D-mode with Doppler



2D-mode with Color and Doppler



2D-mode with M-mode



2D-mode with M-mode and Color



2D-mode with Elastography



2D-mode with Contrast Agent Imaging



2D/Anatomical M-mode

Patient Target Groups 

Adult



Pediatric



Fetal

Intended Use Environment The ultrasound system is a mobile device intended for use in clinical environments. See also: For information about the environmental requirements, refer to Appendix A in this manual.

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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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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 from Siemens Healthineers are compatible with your ultrasound system.

Curved and Linear Array Transducers The following transducers are available on the ACUSON Maple ultrasound system: 

5C1a, 7C2, C5-2v, 14L4a, 16L4, L10-5v, 11M3

The following transducers are available on the ACUSON Maple Select ultrasound system: 

C5-2v, 14L4a, L10-5v Transducer Name

Modes of Operation1

5C1a

2D, C, D, M

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Intended Applications

Exam Types on the System

 Abdominal

 Abd

 Renal

 Renal

 Bowel

 Bowel

 Focused Assessment with Sonography for Trauma

 FAST

 Lung

 Lung

 Obstetrics

 OB

 Early Obstetrics

 Early OB

 Advanced Obstetrics

 OB(Adv)

 Fetal Echocardiography

 Fetal Echo

 Gynecology

 GYN

 Peripheral Venous

 Venous

 Peripheral Arterials

 Arterial

 Pelvis

 Pelvis

 Spine

 Spine

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Transducer Name

Modes of Operation1

Intended Applications

Exam Types on the System

7C2

2D, C, D, M

 Abdominal

 Abd

 Renal

 Renal

 Bowel

 Bowel

 Focused Assessment with Sonography for Trauma

 FAST

 Lung

 Lung

 Obstetrics

 OB

 Early Obstetrics

 Early OB

C5-2v

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2D, C, D, M

 Advanced Obstetrics

 OB(Adv)

 Fetal Echocardiography

 Fetal Echo

 Gynecology

 GYN

 Spine

 Spine

 Pediatric Abdomen

 Ped Abd

 Pelvis

 Pelvis

 Abdominal

 Abd

 Renal

 Renal

 Bowel

 Bowel

 Lung

 Lung

 Obstetrics

 OB

 Early Obstetrics

 Early OB

 Fetal Echocardiography

 Fetal Echo

 Gynecology

 GYN

 Spine

 Spine

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Transducer Name

Modes of Operation1

Intended Applications

Exam Types on the System

14L4a

2D, C, D, M

 Bowel

 Bowel

 Focused Assessment with Sonography for Trauma

 FAST

 Lung

 Lung

16L4

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2D, C, D, M

 Obstetrics

 OB

 Breast

 Breast

 Testis

 Testis

 Penile

 Penile

 Thyroid

 Thyroid

 Pediatric Hip Joint

 Ped Hip

 Carotid

 Carotid

 Peripheral Venous

 Venous

 Peripheral Arterials

 Arterial

 Spine

 Spine

 Musculoskeletal

 MSK

 Digital

 Digital

 Nerve

 Nerve

 Bowel

 Bowel

 Focused Assessment with Sonography for Trauma

 FAST

 Lung

 Lung

 Breast

 Breast

 Testis

 Testis

 Penile

 Penile

 Thyroid

 Thyroid

 Pediatric Hip Joint

 Ped Hip

 Carotid

 Carotid

 Musculoskeletal

 MSK

 Digital

 Digital

 Nerve

 Nerve

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