SONOLINE G20 Ultrasound Imaging System Instructions for Use Sw Ver 1 and 2

SONOLINE G20 Ultrasound Imaging System [1] Instructions for Use

S ie me ns M edi cal Sol uti on s USA , In c .

10031089-ABS-001-01

SONOLINE G20 Ultrasound Imaging System [1] Instructions for Use Software Versions 1 and 2 Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043-1344 U.S.A. (800) 498-7948 (650) 969-9112 CE Declaration This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC of June 14, 1993 concerning Medical Devices. Siemens Medical Solutions USA, Inc., is certified by Notified Body 0123 to Annex II.3 – Full Quality System. Authorized EC Representative: Siemens Aktiengesellschaft Medical Solutions Henkestraße 127 D-91052 Erlangen Germany ©2004-2005 Siemens Medical Solutions USA, Inc. All Rights Reserved. February 2005 Manuals distributed from the Federal Republic of Germany or Japan are printed in the Federal Republic of Germany. Manuals distributed from the United States of America are printed in the United States of America. SONOLINE G20, ReadySet, TGO, THI, MultiHertz, DIMAQ, microCase, SynAps, QuickSet, SuppleFlex, and Evolve Package are trademarks of Siemens Medical Solutions USA, Inc. Windows, CIDEX, CIDEX Plus, CIDEX OPA, Milton, Virkon, and Gigasept FF are registered trademarks of their respective owners.

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

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About This Manual The Instructions for Use consists of two volumes: [1] Instructions for Use The [1] Instructions for Use includes both a general overview and a technical description of the ultrasound imaging system. This manual contains detailed information on the safety and care of the ultrasound system and its transducers. A chapter is dedicated to the description of all system controls. The [1] Instructions for Use also includes the procedures for system setup and beginning an exam. [2] Instructions for Use The [2] Instructions for Use includes procedures for acquiring and optimizing images. This manual provides procedures for general and exam-specific measurements and calculations. The System Reference provides reference information for the ultrasound imaging system.

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Conventions Conventions used throughout this manual are listed below. Take a moment to familiarize yourself with these conventions.

Cross-References This manual provides you information by topic. When additional information exists within this or other manuals, a reference graphic and the name of the book is provided in the right column. If the information exists within the chapter, a cross-reference to the page number is listed. Otherwise, information is referenced by chapter number.

[1] Instructions for Use Screen Saver Intended Use

Ch 1 Ch 1

[2] Instructions for Use Imaging Functions ChA1

System Presets You can use the options and settings available in the system presets menu to set up the ultrasound system with your preferences. Presets define the configuration of the system software whenever you power on the system. A complete listing of system presets is located in the System Reference. Whenever a system preset is discussed in other chapters or in the User and Reference Manuals, a graphic is provided in the right column. The graphic identifies a preset option or setting in the system presets menu that is available for you to customize your ultrasound system. The name of the category on the menu containing the system preset is listed for your convenience.

System Reference Accessories and Options Storage

Ch 2 1-4

F6 Default Settings ► Automatic Freeze Response

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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.

Control Panel Keys, Controls, and Menu Selections Keys and controls located on the control panel are identified by uppercase, boldface type. Example:

Rotate the DEPTH/ZOOM control.

Function keys located on the keyboard are identified by the number of the function key. Example:

Press the F6 key.

Menu selections are indicated with the name of the selection in boldface type. Example:

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Select Next to access the second page of on-screen menu selections.

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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. To select an on-screen object such as a button or a T symbol, roll the trackball to position the pointer (cursor) on the object and then press the SET key on the control panel. In this manual, the term "select" or "click" describe the trackball and SET key action required to select an on-screen object. In the example below, phrases A, B, C, and D are equivalent actions. A. Roll the trackball to the Search button and then press the SET key. B. Select the Search button. C. Click the Search button. D. Click Search.

Special Terms and Menu Options Special terms are indicated in boldface italics and are accompanied by a brief description on their first use in the manual. Example:

Provides on-screen anatomical graphics of pictograms that indicate the anatomy under evaluation.

Within a procedure, options in the system presets are identified in text as boldface type. Example:

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Highlight the Keyboard – Annotation option.

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Table of Contents Instructions for Use Chapter Title

Chapter Description

Chapter 1

General overview of the diagnostic ultrasound imaging system, including system options, features, and design.

Introduction Chapter 2

Safety and Care Chapter 3

System Controls Chapter 4

System Setup

Detailed information on system safety and how to care for and maintain the system, transducers, and transducer accessories. Explanation of all controls and keys on the control panel, alphanumeric keyboard, and optional footswitch. Detailed descriptions of how to transport, set up, and prepare the system for use, including transducer connection and system startup procedures.

Beginning an Examination

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

Chapter 6

Technical description of the ultrasound system.

Chapter 5

Technical Description

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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1 Introduction System Overview ... 3 Configurations ... 3 Language Formats... 3 Transducers... 3 Intended Use... 4 Operating Modes... 5 Image Screen Layout ... 6 Screen Saver ... 6 Documentation and Storage Devices... 7 Measurements and Reports ... 8 User-Defined System Settings... 9 QuickSets ... 9 ReadySet Feature... 9

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1 Introduction

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1 Introduction

System Overview The SONOLINE G20™ system is a portable, digital diagnostic ultrasound imaging system. The system utilizes advanced imaging processing and transducer technology. The operating system is based on Windows® technology. The system software supports 2D-mode and M-mode imaging, standard applications, exam-specific imaging presets, measurements, pictograms, annotations, reports, worksheets, and system diagnostics. The system is equipped with a DIMAQ-IP integrated workstation, including a CD-R/W drive. The workstation provides capabilities for digital acquisition, storage, and review of ultrasound studies. Additional system options provide integration into a networking environment.

[1] Instructions for Use Technical Description Ch 6 Software/Hardware Options Ch 6

The design of this compact and lightweight system allows you access to exam sites where floor space is limited. The ultrasound system can navigate doorways, elevators, mobile van doors, and small examination rooms such as those in clinics, in doctor’s offices, and in emergency departments.

Configurations System configurations: Two standard array transducer ports Two standard array transducer ports and one mechanical sector transducer port1 Two standard array transducer ports and one parking port for linear and curved array transducers

Language Formats Operating system software and control panel overlays support English, German, French, Spanish, and Italian languages.

Transducers Wideband transducer technology supports MultiHertz™ multiple frequency imaging. Multi-frequency capability is available for all imaging transducers. You can connect multiple transducers to the ultrasound imaging system, with one transducer being the active transducer.

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Requires software version 2.0 or higher

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Intended 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.

The SONOLINE G20 ultrasound system supports the following applications:

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Abdominal

Musculoskeletal

Obstetrical

Orthopedic

Gynecological

Cardiac

Endovaginal

Cranial

Urological

Endorectal

Small Parts (Breast, Testicular, Thyroid)

EM (Emergency Medicine)1

System Reference Listing of Transducers and Intended Application

Ch 1

Requires software version 2.0 or higher

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Operating Modes Important: At the time of publication, A-mode was not cleared for use by the U.S. Food and Drug Administration. Before using A-mode, check the current regulations for the country in which you are using this system to determine if A-mode is cleared for use.

A-mode: A-mode is the amplitude mode. It can be displayed in a 2D-mode image. 2D-mode: 2D-mode is the default setting. When the system is powered on, the image screen displays in 2D-mode. Split (B+B) mode: Split mode creates side-by-side images from one 2D-mode image. The two images are simultaneously real-time or frozen. Dual-mode: Dual-mode displays two acquired 2D-mode images. Because the images are obtained separately, only one image at a time displays in real-time. 4B-mode: 4B-mode displays four acquired 2D-mode images. One image at a time displays in real-time. 2D/M-mode: 2D/M-mode displays a 2D image and an M-mode sweep. Split 2D/M-mode: Split 2D/M-mode displays simultaneous 2D-mode images with an M-mode sweep. M-mode: Full screen M-mode display is available.

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

[2] Instructions for Use

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

System Reference

Sample Image Screen

System Presets

Ch A2

Ch 3

EMC Note: Operating the ultrasound imaging system in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations may lead to interference visible on the monitor screen. However, the device has been designed and tested to withstand such interference and will not be permanently damaged.

Screen Saver The screen saver feature automatically replaces the display with a blank screen after the system has been inactive for a specified number of minutes. Restore the screen display by pressing any key or adjusting any control. The first key that you press will restore the view without performing a function. Press the key again to execute the command.

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F6 Display ►Screen Saver Display ►Screen Saver Type Display ►Screen Saver Time

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Documentation and Storage Devices Caution: Peripheral devices specified for use with the ultrasound system are listed in the System Reference. Any use of other devices with the system is at the user's risk.

System Reference Accessories and Options

Ch 2

The system is configured with a CD (compact disk) disk drive for storage of system software, patient data, and images. You can connect one on-board image/report documentation device to the system. Black and white video printer (standard equipment) Videocassette recorder (VCR) Note: Refer to the manufacturer’s instructions for specific information concerning the operation of these devices.

WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards (for example, EN 60950 and IEC 60950 for data processing equipment and EN 60601-1 and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards EN 60601-1-1 and IEC 60601-1-1. Anyone who connects additional equipment to any of the signal input or signal output ports configures a medical system and is therefore responsible that the system complies with the requirements of the system standards EN 60601-1-1 and IEC 60601-1-1. Siemens can only guarantee the performance and safety of the devices listed in the System Reference. If in doubt, consult Siemens service department or your local Siemens representative.

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Measurements and Reports The measurement function is arranged by exam type and is available for use with all exam types. The ultrasound system has measurement and report packages for the following exam types: Obstetrics Early Obstetrics Gynecology Orthopedics

[2] Instructions for Use Measurements and Reports: General Obstetrical EM Urology Rectal Cardiac QuickSets

Ch B1 Ch B2 Ch B3 Ch B4 Ch B4 Ch B5 Ch A1

Urology Cardiac EM (Emergency Medicine)1 Rectal1 Additional specialty measurements include Hip Dysplasia, Residual Volume, and Thyroid Volume.

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Requires software version 2.0 or higher

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User-Defined System Settings You can customize many features of the ultrasound system by using the system presets to designate default settings, or presets. The values are stored in non-volatile memory and will remain intact when the system is powered off. Each user of the system can determine settings for imaging preferences and default settings, then store them on a disk. Those user-defined settings can then be loaded along with new system software. The disk also serves as a backup.

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

[2] Instructions for Use QuickSets

Ch A1

ReadySet Feature Use the ReadySet™ onscreen workflow shortcut feature to provide immediate access to your most frequently-used functions. For example, you can assign an onscreen button to the image rotation function. During imaging, you would roll the trackball to Rotate icon (button) and then press the SET key for each 90° rotation of the image. Use the system presets to assign onscreen buttons to the functions to use with the ReadySet feature. For software versions 2.0 and higher, you can also use the system presets to select a display option for the ReadySet icons (onscreen buttons).

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System References System Presets

Ch 3

F6 ReadySet

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1 Introduction

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2 Safety and Care Operating Safety and Environment ... 3 System Symbols ... 3 Labels ... 7 Biohazard Considerations ... 10 Acoustic Output Mechanical and Thermal Indices ... 12 Mechanical and Thermal Indices ... 12 Transmit Power Control ... 13 Transmit Power Display ... 14 Imaging Functions that Change Acoustic Output ... 15 Transducer Surface Temperature Limits ... 16 Electrical Safety ... 17 Level of Protection Against Electrical Shock Transducers ... 19 Defibrillators ... 19 Pacemakers... 19 Possible Combinations with Other Equipment... 20 Ultrasound System Care ... 21 Daily Checklist ... 21 Maintenance... 22 Repair ... 22 Siemens Authorized Care... 22 Cleaning and Disinfecting ... 24 Cleaning and Disinfecting the System... 24 Cleaning an Air Filter ... 27 Documentation and Storage Devices

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Care ... 29

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Transducers Care ... 30 Cleaning and Disinfecting Transducers... 31 IPX8 Immersion Levels... 33 Approved List of Disinfectants ... 35 Storage... 36 Repair ... 36 Protective case... 36 Transducer Accessories Care... 37 Transducer Sheaths... 37 Storage... 37 Gel Pad ... 38 Storage... 38 Needle Guide Bracket Kits... 39 Storage and Transportation ... 39 Cleaning, Disinfecting, and Sterilizing Needle Guide Bracket Kits ... 39 Storage... 42

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