• Author / Uploaded
• Hadiba

Citation preview

SONOLINE G20 User and Reference Manuals

[1] Instructions for Use [2] Instructions for Use System Reference Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration

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.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

i

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.

ii

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

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

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

iii

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:

iv

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

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

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:

[ 1 ]

Highlight the Keyboard – Annotation option.

I N S T R U C T I O N S

F O R

U S E

v

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.

vi

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

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

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 - 1

1 Introduction

1 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

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.

1

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 - 3

1 Introduction

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:

1

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

1 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 Introduction

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.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 - 5

1 Introduction

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.

1 - 6

[ 1 ]

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

I N S T R U C T I O N S

F O R

U S E

1 Introduction

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.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 - 7

1 Introduction

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.

1

Requires software version 2.0 or higher

1 - 8

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

1 Introduction

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).

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

System References System Presets

Ch 3

F6 ReadySet

1 - 9

1 Introduction

1 - 10

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

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

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

Care ................................................. 29

2 - 1

2 Safety and Care

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

2 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Operating Safety and Environment Do not operate the ultrasound imaging system until you fully understand the safety considerations and procedures presented in this manual.

[1] Instructions for Use System Controls

Ch 3

System Symbols The table below is provided for your identification of important symbols located in labels on the ultrasound imaging system and transducers. Symbol

Explanation Alternating Current V~

AC (alternating current) voltage source Caution: Risk of electric shock.

Type BF Defibrillator-proof Patient Connection

Type BF Applied Part

Type CF Patient Connection

Consult Operator's Manual Equipotential Connection

Footswitch Connector Headphone Connection Degauss Control Monitor self test

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 3

2 Safety and Care

Symbol

Explanation Monitor Contrast control

Monitor Brightness control

Protective Earth Ground Signal Earth Ground Signal Input Signal Output Video Connection (monochrome video signals) Start (of action for equipment)

Digital Interface, RS-232-C connection USB Connection Ethernet 10/100BaseT Connection Status Indicator for DC Power Good (Green) or Green Indicator Light

Printer Connection Electronic Array Transducer Port (for standard transducers) Mechanical Sector Transducer Port (for mechanical sector transducers) Parking Port (for linear and convex transducers)

Transducer unlock (left) and lock (right) positions

2 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Symbol

Explanation

Unlocked position

Locked position

Audio

Audio Level Shelf Weight Restriction

ON only for MAINS control OFF only for MAINS control Power "On" standby switch

2 Safety and Care

Symbol

Explanation

D E209216

DEMKO-Denmark approval mark.

UL symbol for listing as recognized components for Canada and United States of America Gost-R symbol indicates that this product is certified for conformity to the safety requirements of Russian state standards. (Installierte Volumen Komponente)

IVK

Identifier of selected system components or parts for product traceability. UL Listing Mark

Bar Code 9 Volt Battery

Date of Manufacture symbol with the date below

2 - 6

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Labels

1 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

X-ray shielding notice System warning label Identification label Certification label

2 - 7

2 Safety and Care

Example of X-ray shielding notice: "X-ray emission complies with FDA (DHHS) radiation performance standards, 21 CFR subchapter J applicable at date of manufacture."

1

Location of Identification Label

Example of system warning label.

2 - 8

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Example of identification label.

Example of certification label – 115V, 230V.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

Example of certification label – 230V.

2 - 9

2 Safety and Care

Biohazard Considerations WARNING: This equipment is not suitable for intracardiac use or direct cardiac contact. WARNING: For neonatal head imaging, Siemens recommends that you exercise special care during neonatal cephalic scanning to avoid possible damage to the posterior region of the eye. The ultrasound energy emitted by the transducer easily penetrates the fontanels of the infant. WARNING: Siemens makes every effort to manufacture safe and effective transducers. You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, and during endocavity or intraoperative scanning; during biopsy or puncture procedures; or when scanning patients with open wounds. WARNING: To eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials, always dispose hazardous or infectious materials according to medical regulations for biohazardous waste. WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. WARNING: Ultrasound energy is transmitted more effectively through water than through tissue. When using a standoff device of any kind, for example, a gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the output display on the system.

2 - 10

[ 1 ]

[1] Instructions for Use Transducer Care

I N S T R U C T I O N S

F O R

2-30

U S E

2 Safety and Care

The assessment of the biological effects of diagnostic ultrasound on humans is a subject of ongoing scientific research. This system, and all diagnostic ultrasound procedures, should be used for valid reasons, for the shortest possible period of time, and at the lowest mechanical and thermal indices necessary to produce clinically acceptable images. According to the ALARA (As Low As Reasonably Achievable) principles, acoustic output should be set to the lowest level required to satisfactorily perform the examination.

System Reference Acoustic Output

Ch 1

The ultrasound imaging system complies with the standards of the American Institute of Ultrasound in Medicine (AIUM), the National Electrical Manufacturer's Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA), and the guidelines of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output levels. The ultrasound output levels are stated to permit the user to critically evaluate the system settings in the event of new research findings being announced.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 11

2 Safety and Care

Acoustic Output Thermal Indices

Mechanical and

WARNING: Ultrasound procedures should be used for valid reasons, for the shortest period of time, and at the lowest mechanical/thermal index setting necessary to produce clinically acceptable images.

The ultrasound system incorporates an output display of Mechanical and Thermal Indices to allow you to monitor, and to limit, the amount of ultrasound energy that is transferred to the patient.

System Reference

Note: For systems distributed in the United States of America, refer to the Medical Ultrasound Safety ultrasound education program brochure produced by the AIUM that is included in the System Reference.

[1] Instructions for Use

Mechanical and Thermal Indices

Acoustic Output

Changing the Transmit Power Transmit Power Display

Ch 1

2-13 2-14

. . .

. . . . .

The system displays the Mechanical and Thermal Indices during real-time imaging, in all imaging modes, when the Mechanical Index or the Thermal Indices are equal to or exceed a value of 0.4.

130

Location of mechanical and thermal indices on the image screen.

Indices display in the abbreviated form shown below: MI:

Mechanical Index

TIB:

Bone Thermal Index (fetal application)

TIS:

Soft Tissue Thermal Index

TIC:

Cranial Thermal Index

2 - 12

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Transmit Power Control Adjust the transmit power and the corresponding acoustic pressure delivered through the transducer to the patient by using the designated control on the system. It is the main system function that determines the transmitted intensity of ultrasound for all transducers and imaging modes during real-time imaging, though it is not the only function that affects the mechanical and thermal indices. The range and especially the maximum level of the mechanical and thermal indices differ depending on the transducers. In addition, each diagnostic exam type has preset values for mechanical and thermal indices.

[1] Instructions for Use Functions Affecting Acoustic Output 2-15

Note: Maximum transmit acoustic intensity and the mechanical index for each exam type are limited in accordance with the United States Food and Drug Administration's (FDA) recommendations and guidelines. System default transmit intensity and mechanical index values are always below the FDA recommendations for each exam type. Although some exam types may default to a condition of maximum allowable transmit power, there are other system controls or functions that could raise acoustic output levels.

To adjust the transmit power: 1. During real-time 2D-mode or M-mode imaging, press the MENU key on the control panel. The system displays the default menu or the menu last viewed. 2. Roll the trackball to highlight the menu category (2D or M) at the top of the menu on the left of the screen and then press the SET key. The system displays the list of available menu categories. 3. Roll the trackball to highlight Tx and then press the SET key. 4. To increase the transmit power, roll the trackball to highlight Tx Power and then press the SET key. You can alternately rotate the SELECT control when Tx Power is active. 5. To decrease the transmit power, roll the trackball to highlight Tx Power and then press the SET key. You can alternately rotate the SELECT control when Tx Power is active. 6. Press the MENU key to exit the menu.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 13

2 Safety and Care

Transmit Power Display The transmit power range is from –20 dB to 0 dB. Selecting 0 dB, or 100%, in combination with other system controls or functions generates the maximum acoustic intensity and mechanical index for each transducer, where: ISPTA.3 : ≤ 720 mW/cm2 and MI ≤ 1.9 Use the system presets to determine whether the power value displays on the image screen in decibels, dB, or as a percentage of the maximum allowable power. 0 dB

-3 dB

-6 dB

-9 dB

-12 dB

-15 dB

-18 dB

-21 dB

-24 dB

100%

71%

50%

35%

25%

18%

13%

9%

6%

System Reference System Presets

Ch 3

F6 General ►Beep Volume ►Tx Power Display Format

Comparison of decibels to percentages.

. . .

. . . . .

When the power level is changed, the system briefly highlights the power value to indicate the change.

130

Location of power display on the image screen.

2 - 14

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Imaging Functions that Change Acoustic Output WARNING: Observe the real-time display of mechanical and thermal indices (MI/TI) at all times.

In addition to the adjustment of the transmit power, adjustment of the following imaging functions and/or controls may affect the acoustic output: Automatic Time-out Exam Type Field of View (Scan Angle); 2D Steering Angle for linear array transducers Focus Frame Rate Resolution/Speed setting Density setting Freeze Image Depth Imaging Mode Multi-Frequency Power On/Off System Presets and QuickSets THI (using MULTIHERTZ control) Transducer Gel Pad Use

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 15

2 Safety and Care

Transducer Surface Temperature Limits The following table provides the maximum surface temperature of the transducers compatible with the system. Maximum surface temperatures are in accordance with IEC 60601-2-37. Maximum Temperature Transducer

TMM

Still Air

C4-2

< 42.4° C

< 41.0° C

C5-2

< 41.2° C

< 41.0° C

C8-5

< 41.0° C

< 41.0° C

7.5L75S

< 41.0° C

< 41.0° C

L10-5

< 41.5° C

< 41.0° C

EV9-4

< 41.6° C

< 41.0° C

EC9-4

< 41.8° C

< 41.4° C

Endo-V II

< 41.0° C

< 41.0° C

Endo-P II

< 41.0° C

< 41.0° C

TMM = Tissue Mimicking Material

2 - 16

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Electrical Safety WARNING: For 115V systems: To ensure grounding reliability, only connect the system to a hospital-grade power outlet. WARNING: The AC power connector plug for the ultrasound system is a three-prong grounded plug (in the U.S.A.) and should never be adapted to any two-prong (non-grounded) outlet, either by modifying the plug or by using an adapter. In the U.S.A., proper grounding requires the AC power connector plug to be plugged into a hospital-grade power outlet. WARNING: To avoid electrical shock, never modify the ultrasound system's AC power connector plug, as doing so may overload your facility's power circuits. To ensure grounding reliability, connect the system only to an equivalent outlet. WARNING: To avoid electrical shock, never use equipment that shows signs of wear or tampering, or whose ground plug has been bypassed using an adapter. WARNING: Equipment connected to the ultrasound system and in the patient zone must be powered from a medically-isolated power source or must be a medically-isolated device. Equipment powered from a non-isolated source can result in chassis leakage currents exceeding safe levels. Chassis leakage current created by an accessory or device connected to a non-isolated outlet may add to the chassis leakage current of the ultrasound system. WARNING: Using an extension cord or multi-socket outlet setup to provide power to the imaging system, or to the system's peripheral devices may compromise the system grounding and cause your system to exceed leakage current limits. WARNING: To avoid electrical shock and damage to the ultrasound system, power off and unplug the equipment from the AC power outlet before cleaning and disinfecting. WARNING: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the electrical circuitry may cause excessive leakage current or system failure. WARNING: To ensure proper grounding and leakage current levels, it is the policy of Siemens to have an authorized Siemens representative or Siemensapproved third party perform all on-board connections of documentation and storage devices to the ultrasound system.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 17

2 Safety and Care

WARNING: To maintain the safety and functionality of the ultrasound system, maintenance must be performed every 12 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed. Caution: To avoid the possibility of static shock and damage to the system, avoid the use of aerosol spray cleaners on the monitor screens. Caution: Do not use spray cleaners on the ultrasound system, as this may force cleaning fluid into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components. EMC Note: Operating the ultrasound 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.

2 - 18

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Level of Protection Against Electrical Shock Transducers WARNING: Only use Type BF transducers with the ultrasound system to maintain a level of protection against electrical shock.

According to EN 60601-1 and IEC 60601-1, the assemblies for the endocavity transducers, linear array transducers, and curved array transducers provide a "Level of Protection Against Electrical Shock" of "Type BF."

The Type BF icon is located on the transducer label.

Defibrillators WARNING: The ECG function is designed to withstand the effects of defibrillation. However, when possible, disconnect the ECG leads during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient.

For patient safety, be sure to use defibrillators that do not have grounded patient circuits.

Pacemakers WARNING: Pacemakers may be susceptible to the high frequency electrical signal generated by ultrasound equipment. Use precautions when using ultrasound equipment on or near someone with a pacemaker. If there is interference, immediately discontinue the examination and power off the ultrasound system.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 19

2 Safety and Care

Possible Combinations with Other Equipment 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.

System Reference Peripheral Equipment

Ch 2, Ch 4

The ultrasound system is capable of supporting one on-board documentation device.

2 - 20

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Ultrasound System

Care

It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic operation on a daily basis. Each day, prior to using the system, perform each of the steps in the Daily Checklist. All exterior parts of the system, including the control panel, keyboard, transducers, and biopsy devices, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect components to kill vegetative organisms and viruses. The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter weekly, and clean as needed.

Daily Checklist Perform the following each day before using the ultrasound system: Visually inspect all transducers. Do not use a transducer which has a cracked, punctured, or discolored casing or a frayed cable. Discoloration Exception: The use of Cidex OPA and Gigasept FF disinfectants may cause discoloration of transducer housings. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

Visually inspect all power cords. Do not turn on the power if a cord is frayed or split, or shows signs of wear.

[1] Instructions for Use Air Filters Approved List of Disinfectants

2-27 2-35

If your system's power cord is frayed or split, or shows signs of wear, contact your Siemens service representative for power cord replacement. Verify that the trackball, DGC slide controls, and other controls on the control panel are clean and free from gel or other contaminants. Once the system is powered on: Visually check the on-screen displays and lighting. Verify that the monitor displays the current date and time. Verify that the transducer identification and indicated frequency are correct for the active transducer.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 21

2 Safety and Care

Maintenance WARNING: To maintain the safety and functionality of the ultrasound system, maintenance must be performed every 12 months. Electrical safety tests must also be performed at regular intervals as specified by local safety regulations, or as needed.

Repair For questions regarding repair or replacement of any equipment parts on your system, contact your Siemens service representative.

Siemens Authorized Care Installers and operators must observe any statutory regulations that govern the installation, operation, inspection, and maintenance of this equipment. To ensure the safety of patients, operators, and third parties, the equipment must be inspected every 12 months, and the replacement of parts is performed as necessary. This maintenance must be performed by a qualified Siemens authorized representative. It is important to inspect the equipment more frequently if it is operated under extraordinary conditions. Perform inspections and maintenance at the prescribed intervals to avoid worn and hazardous parts due to wear. Contact the Siemens service department for information regarding the required maintenance. As manufacturers and installers of ultrasound equipment, Siemens cannot assume responsibility for the safety properties, reliability, and/or performance of the equipment, if: Installations, extensions, readjustments, modifications, additions, or repairs are carried out by persons not specifically authorized by Siemens. Components that affect the safe operation of the system are replaced by parts not authorized by Siemens. The electrical installation of the room where the equipment is located does not meet the power and environmental requirements stated in this manual. The equipment is not used in accordance with the operating instructions. The system is operated by personnel not adequately educated or trained.

2 - 22

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Siemens suggests that you request any person who performs maintenance, or repairs, to provide you with a certificate showing: The nature and extent of the work performed Changes in rated performance Changes in working ranges Date of service Name of person or firm performing the service Signature of person performing the service Technical documentation pertinent to the imaging system is available at an additional charge. However, this does not in any way constitute an authorization to conduct repairs or maintenance. Siemens refuses all responsibility whatsoever for repairs that are performed without the express written consent of the Siemens service department. 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 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.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 23

2 Safety and Care

Cleaning and Disinfecting You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. Use universal precautions when cleaning and disinfecting. You should treat all portions of the imaging system that come in contact with human blood or other body fluids as if they were known to be infectious. All exterior parts of the system, including the control panel, transducers, and biopsy devices, should be cleaned and/or disinfected as necessary or between uses. Clean each component to remove any surface particles. Disinfect the components to kill vegetative organisms and viruses.

Cleaning and Disinfecting the System WARNING: To avoid electric shock and damage to the system, always power off and disconnect the equipment from the AC power source before cleaning and disinfecting. WARNING: Contents of some disinfecting agents are known to be health hazards. Their concentration in the air must not exceed an applicable specified limit. Comply with the manufacturer's instructions when using these agents. Caution: To avoid the possibility of static shock and damage to the ultrasound system, avoid the use of aerosol spray cleaners on the monitor screens. Caution: Do not clean the system with chlorinated or aromatic solvents, acidic or basic solutions, isopropyl alcohol or strong cleaners such as ammoniated products, as these can damage the surface of the system. Isopropyl alcohol exception: It is acceptable to use isopropyl alcohol when cleaning the trackball assembly only. Use the recommended cleaning procedure.

[1] Instructions for Use Trackball Cleaning

2-26

Caution: Do not use spray cleaners on the ultrasound system, or pour fluid onto the system surfaces, as fluid can seep into the system and damage electronic components. It is also possible for the solvent fumes to build up and form flammable gases or damage internal components. Caution: Do not pour any fluid onto the ultrasound system surfaces, as fluid seepage into the electrical circuitry may cause excessive leakage current or system failure.

2 - 24

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

System Surfaces The following instructions describe cleaning the surface of the ultrasound system, including the trackball and transducer holder. To clean the surface of the ultrasound system: 1. Power off ( ) the ultrasound system and unplug the power cord from the power outlet.

2. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to wipe the surface of the ultrasound system. Take particular care to clean the areas near the trackball and the slide controls. Ensure these areas are free of gel and any other visible residue. Ensure that cleaning solution does not seep into the control panel, keyboard, or any other openings. 3. After cleaning, use a clean, lint-free cloth to dry the surface. 4. After cleaning, reconnect the ultrasound system power cord into the power outlet. To clean the optional monitor filter: 1. Power off ( ) the ultrasound system and unplug the power cord from the power outlet.

2. Use the cloth provided with the optional monitor filter to gently wipe the surface of the filter. To clean the holders for transducers and coupling gel: 1. Remove the holder from the ultrasound system: Reach under the holder to locate the tab on the holder. The tab extends below the point of attachment to the ultrasound system. Squeeze the tab towards the holder and pull the holder downward.

[1] Instructions for Use Holder attachment and detachment Ch 4

2. Clean the holder under running water, using a mild detergent and dry with a lint-free cloth. 3. Reattach the holder to the ultrasound system: Align the support on the holder directly below the point of attachment on the ultrasound system and firmly push upwards until the holder snaps into place.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 25

2 Safety and Care

To clean the trackball: Caution: Do not drop or place foreign objects inside the trackball assembly. This may affect the trackball's operation and damage the system.

1. Remove the front panel bezel. 2. Remove the trackball. 3. Clean the trackball with tissue and isopropyl alcohol. 4. Clean the inside of the trackball assembly with a cotton swab and isopropyl alcohol, paying particular attention to the X and Y encoders and the idler wheel. 5. Allow the assembly parts to completely dry before reassembly. 6. Replace the trackball and front panel bezel. 1 2

Front panel bezel Trackball

1 2

X and Y encoders Idler wheel

Example of trackball assembly.

2 - 26

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Cleaning an Air Filter The air filter on the ultrasound system must be cleaned regularly to maintain proper system cooling. Remove and check the air filter weekly, and clean as needed.

1

Location of Air Filter

1

Location of air filter.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 27

2 Safety and Care

To remove and clean the air filter: Caution: Do not scrub, stretch, or bend the filter, or apply heat to the filter, as doing so could damage the filter.

1. Power off and unplug the power cord from the power outlet. 2. Grasp the filter by its tab and pull it out of the slot. 3. Rinse the air filter with running water and allow the filter to completely dry. To hasten drying, you may gently shake the filter, or blot the filter with a clean, lint-free cloth. Caution: Do not insert a wet filter as this can damage the system.

4. Slide the air filter back into the ultrasound system. 5. Plug the power cord into the power outlet.

2 - 28

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Documentation and Storage Devices Care For information on the care of an optional documentation or storage device, please refer to the manufacturer's operating instructions that accompanied the device.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 29

2 Safety and Care

Transducers

Care

WARNING: Always place a sterile, non-pyrogenic transducer sheath on a transducer used in procedures requiring sterility. WARNING: To minimize the risk of cross-contamination and infectious diseases, endocavity and intraoperative transducers must be cleaned and high-level disinfected after each use. A sterile, non-pyrogenic transducer sheath must be in place during procedures requiring sterility. WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. WARNING: During neurosurgical procedures, if a transducer becomes contaminated with tissue or fluids of a patient known to have Creutzfeld-Jacob disease, the transducer should be destroyed, as it cannot be sterilized. WARNING: When using an endocavity or intraoperative transducer with a CF type applied part, the patient leakage currents may be additive. WARNING: The outer surfaces of an endocavity or intraoperative transducer should be checked to ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause a safety hazard. Caution: Transducers are sensitive instruments – irreparable damage may occur if they are dropped, knocked against other objects, cut, or punctured. Do not attempt to repair or alter any part of a transducer. Caution: To avoid cable damage, do not roll the system over transducer cables. Caution: To avoid damage to the transducer, do not use transducer sheaths containing an oil-based coating or petroleum- or mineral oil-based ultrasound coupling agents. Use only a water-based ultrasound coupling agent. Caution: Follow all instructions provided by manufacturers of sterile goods (transducer sheaths) to ensure proper handling, storage, and cycling of all sterile goods.

Take extreme care when handling or storing transducers. They must not be dropped, jarred, or knocked against other objects. Do not allow transducers to come into contact with any sharp-edged or pointed object.

2 - 30

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Cleaning and Disinfecting Transducers WARNING: To avoid electrical shock and damage to the system, disconnect the transducer prior to cleaning or disinfecting. WARNING: Disinfectants and cleaning methods listed are recommended by Siemens for compatibility with product materials, not for biological effectiveness. Refer to disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses.

[1] Instructions for Use High-level disinfection Immersion Levels

2-32 2-33

Caution: Do not sterilize transducers using hot steam, cold gas, or Ethylene Oxide (ETO) methods. Before applying any other methods which might be recommended by manufacturers of sterilization equipment, please contact your Siemens representative. Caution: To avoid damage to the transducer, observe the immersion levels indicated for each transducer type. Do not immerse or allow the cable or connector of a transducer to become wet. Caution: The transducers have been designed and tested to be able to withstand high-level disinfection as recommended by the manufacturer of the disinfectant product. Carefully follow the disinfectant manufacturer's instructions. Do not immerse for more than one hour. Caution: Do not use abrasive cleaning agents, organic solvents such as benzene, isopropyl alcohol, or phenol-based substances, or cleaning agents containing organic solvents to clean or disinfect transducers. These substances can damage the transducers. Caution: Do not use a spray cleaner on a transducer, as this may force cleaning fluid inside the housing and damage the transducer.

All transducers should be cleaned and disinfected prior to their use on each patient. Endocavity and intraoperative transducers require high-level disinfection prior to use.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 31

2 Safety and Care

To clean and disinfect a transducer: 1. Disconnect the transducer from the system. 2. Moisten a clean gauze pad with water and wipe the transducer to remove any gel or particles remaining on the transducer. 3. Carefully wipe the entire transducer, including the cable and connector. 4. To disinfect the transducer, take care to keep the cable strain relief and connector of the transducer dry while immersing the transducer in an approved disinfectant to the level indicated in the following illustration. 5. Carefully follow the disinfectant manufacturer's instructions. 6. After cleaning or disinfecting, use a clean cloth to dry the transducer. To high-level disinfect a transducer: 1. Disconnect the transducer from the system. 2. Thoroughly clean, rinse, and dry the transducer. 3. Take care to keep the cable strain relief and connector of the transducer dry while immersing the transducer in an approved disinfectant to the level indicated in the following illustration. 4. Carefully follow the manufacturer's instructions for high-level disinfection. 5. After high-level disinfecting, use a clean cloth to dry the transducer.

2 - 32

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

IPX8 Immersion Levels Caution: To avoid damage to the transducer, observe the immersion levels indicated for each transducer type. Transducers with the protection level IPX8 are indicated by the presence of the "IPX8" symbol on the connector of the transducer. If a transducer does not have the "IPX8" symbol on the connector of the transducer, then observe the immersion levels provided in the illustration for Non-IPX8 transducers.

Transducers meet Ingress Protection level IPX8 of EN 60539 and IEC 60539 to the depth of the immersion line shown in the illustration only for transducers with the "IPX8" symbol on the connector of the transducer.

Example of transducer labels with IPX8 symbol.

!

EC9-4, EV9-4, Endo-V II

Linear

Curved

IPX8 Immersion Levels.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 33

2 Safety and Care

Non-IPX8 Immersion Levels Caution: To avoid damage to the transducer, observe the immersion levels indicated for each transducer type. Transducers without the protection level IPX8 do not have the "IPX8" symbol on the connector of the transducer. If a transducer does not have the "IPX8" symbol on the connector of the transducer, then observe the Non-IPX8 Immersion Level illustration,

!

1

Endo-P II

20 cm (Endo-P II)

7.5L75S

Non-IPX8 Immersion Levels. Note: Non-IPX8 transducers meet Ingress Protection level IPX7 to the depth of the immersion line shown in the above illustration.

2 - 34

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Approved List of Disinfectants The following matrix provides a list of approved disinfectants for all transducers. Note: Cidex OPA and Gigasept FF may discolor transducer housings. There is no associated degradation of imaging performance or transducer reliability.

Cidex

Cidex Plus

Cidex OPA

Milton

Virkon

Gigasept FF

C4-2 C5-2 C8-5 7.5L75S L10-5 EC9-4 EV9-4 Endo-V II

NC

Endo-P II

NA

NA

NA

= compatible NC = not compatible NA = not applicable (not tested)

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 35

2 Safety and Care

Storage Store transducers in a clean and dry environment. Extreme temperatures or humidity may damage a transducer.

Repair Do not attempt to repair or alter any part of the transducer. Contact your service representative at Siemens immediately if a transducer appears to be damaged or malfunctions in any way.

Protective case Due to the mechanical sensitivity of transducers, Siemens recommends that you always use the transducer case when you ship a transducer or transport it from one place of examination to another. The case is specially designed to protect the sensitive parts of the transducer. Be sure that all parts of the transducer are properly placed inside the case before you close the lid.

2 - 36

[ 1 ]

[1] Instructions for Use System Care Temperatures

I N S T R U C T I O N S

F O R

2-21 Ch 6

U S E

2 Safety and Care

Transducer Accessories

Care

WARNING: Ensure the accessories for a transducer are properly cleaned, sterilized or disinfected as appropriate before each use to avoid possible patient contamination.

[2] Instructions for Use Attachment Procedures

Ch C1

Instructions for care are provided for the following accessories for transducers: Transducer Sheaths Gel pads Needle Guide Bracket Kits

Transducer Sheaths WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. WARNING: To minimize the risk of cross-contamination and infectious diseases, endocavity transducers must be cleaned and high-level disinfected after each use. A sterile, non-pyrogenic transducer sheath must be in place during procedures requiring sterility. Caution: Siemens recommends that you follow all instructions provided by manufacturers of sterile goods (transducer sheaths) to ensure proper handling, storage, and cycling of all sterile goods.

Using a disposable latex transducer sheath on a transducer reduces the possibility of cross-contamination. Always use a protective transducer sheath for endocavity exams, and when scanning an open wound or an area where the skin is not intact.

Storage Caution: Do not store transducer sheaths in direct sunlight, as ultraviolet damage can result.

Latex products have a limited shelf life, and should be stored in a cool, dry, dark place with an ambient temperature between –5°C and +40°C and up to 80% relative humidity at +40°C. Before use, examine these products for any material flaws. Some packaging may list an expiration date. Any product showing flaws, or whose expiration date has passed, should not be used.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 37

2 Safety and Care

Gel Pad Before use, examine the gel pad for any material flaws. Thinning, bulging, or brittleness of the material indicates damage. Any product showing flaws should not be used.

Storage Do not store gel pads below 5°C nor above 57°C. Gel pads have a limited shelf life. Before use, examine these products for any material flaws. Some packaging may list an expiration date. Any product showing flaws, or whose expiration date has passed, should not be used.

2 - 38

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Needle Guide Bracket Kits WARNING: If a needle guide becomes contaminated with tissue or fluids of a patient known to have Creutzfeld-Jacob disease, then the needle guide should be destroyed. Sterilization is not effective against Creutzfeld-Jacob contamination.

Needle guide bracket kits are available for biopsy and puncture procedures for specific transducers.

[2] Instructions for Use Compatible Transducers

Ch C1

Storage and Transportation Always clean and sterilize or high-level disinfect components used in a needle puncture or biopsy procedure after each use.

Cleaning, Disinfecting, and Sterilizing Guide Bracket Kits

Needle

EC9-4 Disposable Endocavity Needle Guide WARNING: The needle guide is packaged sterile and is a single-use item. Do not use if the packaging indicates signs of tampering or if the expiration date has passed.

The disposable endocavity needle guide is a single-use item. Refer to the in-box instructions for disposal instructions.

EC9-4 Stainless Steel Endocavity Needle Guide WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use.

The stainless steel endocavity needle guide is a reusable item. Refer to the in-box instructions for attachment and care procedures, including cleaning and sterilization.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 39

2 Safety and Care

6.5EV13 Needle Guide Bracket Kit (EV9-4) WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use.

To clean: 1. Rinse the guide under water, and then scrub the inside of the guide with a brush. 2. Visually inspect the guide to make sure all debris is removed. To sterilize: 1. Prior to sterilization, clean the needle guide. 2. Sterilize holders and needle guides using steam at a temperature of 121°C to 123°C for an exposure time of 15 to 30 minutes. This is a gravity-displacement steam sterilization method.

Endo-V II Needle Guide Bracket Kit WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use.

To clean: 1. Rinse the guide under water, and then scrub the inside of the guide with a brush. 2. Visually inspect the guide to make sure all debris is removed. To sterilize: 1. Prior to sterilization, clean the needle guide. 2. Sterilize holders and needle guides using steam at a temperature of 121°C to 134°C for an exposure time of 15 to 30 minutes. This is a gravity-displacement steam sterilization method.

2 - 40

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 Safety and Care

Endo-P II Needle Guide Bracket Kit WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use.

To clean: 1. Rinse the guide under water, and then scrub the inside of the guide with a brush. 2. Visually inspect the guide to make sure all debris is removed. To sterilize: 1. Prior to sterilization, clean the needle guide. 2. Sterilize holders and needle guides using steam at a temperature of 121°C to 123°C for an exposure time of 15 to 30 minutes. This is a gravity-displacement steam sterilization method.

S-Array Needle Guide Bracket Kit (7.5L75S) WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use.

To clean: 1. Rinse the guide under water, and then scrub the inside of the guide with a brush. 2. Visually inspect the guide to make sure all debris is removed. To sterilize: 1. Prior to sterilization, clean the needle guide. 2. Sterilize holders and needle guides using steam at a temperature of 121°C to 123°C for an exposure time of 15 to 30 minutes. This is a gravity-displacement steam sterilization method.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

2 - 41

2 Safety and Care

Universal Needle Guide, Stainless WARNING: Needle Guide Bracket kits are packaged non-sterile. Sterilize these products prior to their first use. Refer to the sterilization procedures for the Universal Needle Guide in the following pages.

Prior to sterilization, clean the universal needle guide bracket and insert(s) using an enzymatic cleaner. To clean: 1. Rinse the bracket and insert(s) with water. 2. Soak the bracket and insert(s) in an enzymatic cleaner. Carefully follow the manufacturer's instructions. 3. Rinse the bracket and insert(s) with water to remove any debris and remaining cleaner. To sterilize: Sterilize the bracket and needle guide insert(s) using a wrapped, gravity-displacement steam sterilization at a temperature of 121ºC to 123ºC for an exposure time of 15 to 30 minutes.

Storage Always clean and sterilize components used in a needle puncture or biopsy procedure after each use.

2 - 42

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls Control Panel ...................................................................................................... 5 Control Panel Lighting ................................................................................... 6 Control Panel Audio Signal ............................................................................ 6 Trackball ........................................................................................................ 6 Trackball Assignment ............................................................................. 7 Select ............................................................................................................ 8 Caliper ........................................................................................................... 9 Freeze............................................................................................................ 9 Selection and Entry Keys............................................................................. 10 Escape.................................................................................................. 10 Set........................................................................................................ 10 Menu.................................................................................................... 10 2D-Mode and M-Mode Imaging Controls .................................................... 11 2D......................................................................................................... 11 Split ...................................................................................................... 11 Dual/Select ........................................................................................... 12 4B......................................................................................................... 12 M.......................................................................................................... 13 L/R Flip ................................................................................................. 13 Image Parameter Controls........................................................................... 14 Transducer ........................................................................................... 14 MultiHertz ............................................................................................ 14 DGC...................................................................................................... 14 Depth/Zoom ......................................................................................... 15 Focus.................................................................................................... 16

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 1

3 System Controls

Pictograms and Annotation ......................................................................... 17 Text ...................................................................................................... 17 Pictogram ............................................................................................. 17 Documentation Controls.............................................................................. 18 Print Store ............................................................................................ 18 Digital Store 1....................................................................................... 18 Digital Store 2....................................................................................... 18 Review ................................................................................................. 19 Special Function Controls ............................................................................ 19 CINE ..................................................................................................... 19 Alphanumeric Keyboard .................................................................................. 20 Shortcut Keys .............................................................................................. 20 Special Characters ....................................................................................... 21 Function Keys.............................................................................................. 22 F1 – New Patient.................................................................................. 22 F2 – Report........................................................................................... 22 F3 – Patient Data .................................................................................. 22 F4 – Patient Browser............................................................................ 22 F5 – Exam ............................................................................................ 22 F6 – Preset Menu................................................................................. 23 F7 – (Task Light)............................................................................. 23 F8 – QuickSet....................................................................................... 23 F9 – Arrow............................................................................................ 23 F10 – Home.......................................................................................... 23 F11 – Home Set ................................................................................... 24 F12 – Delete Word ............................................................................... 24 F13 – Hide Text .................................................................................... 24 F14 – Clear Screen ............................................................................... 24 F15 – Biopsy......................................................................................... 24 Other Alphanumeric Keys............................................................................ 25 Arrows.................................................................................................. 25 Alt......................................................................................................... 25 Backspace ............................................................................................ 25 Caps Lock............................................................................................. 25 Ctrl........................................................................................................ 25 Enter..................................................................................................... 25 Shift...................................................................................................... 26 Space Bar ............................................................................................. 26 Tab ....................................................................................................... 26 Video I/O .............................................................................................. 26

3 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Footswitch ........................................................................................................ 27 Menu Selections............................................................................................... 27 Transmit Power Selections.......................................................................... 27 2D-Mode Selections .................................................................................... 28 M-Mode Selections ..................................................................................... 29 CINE Selections........................................................................................... 29 Selections for 2D-Mode Measurements and Calculations........................... 30 Selections for M-Mode Measurements and Calculations ............................ 31 Selections for All Measurements and Calculations...................................... 31 Biopsy/Puncture Selections......................................................................... 31 Selections in DIMAQ-IP (Patient Data Management) ................................... 32 Study Screen DIMAQ-IP ........................................................................... 32 Image Screen DIMAQ-IP........................................................................... 34 Options Dialog Box............................................................................... 35 DICOM Screen Selections ............................................................................... 36 Study Screen ............................................................................................... 36 Image Screen .............................................................................................. 37 DICOM Screen ............................................................................................ 37 Printer Layout Pages ............................................................................ 38 Print and Store Queues ........................................................................ 39

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 3

3 System Controls

3 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Control Panel The controls for all imaging modes, parameters, documentation, and system selections are designed to promote quick learning and recognition of the controls and functions. The ultrasound imaging system has a combination of keys, rotary knobs, push and rotate controls, push controls, and function keys. A trackball provides direct access to calipers, menu items, and other imaging functions. These keys and controls are logically arranged to require a minimum number of hand and eye movements.

[1] Instructions for Use Keyboard

3-20

Language overlays for the control panel are available. The locations and functions of the keys and controls are not impacted by the overlay.

Example of the control panel on the ultrasound imaging system.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 5

3 System Controls

Control Panel Lighting When the imaging system is in use, all controls on the main control panel are back-lit. The system increases the lighting intensity of most active controls to show you, at a glance, which functions are active. The LED lamps located under the front of the monitor provide additional task lighting. Use the F7 key on the keyboard to turn the task lighting on and off.

Control Panel Audio Signal

System Reference System Presets

Ch 3

F6

Use the system presets to deactivate or adjust the volume of the beep.

General ► Beep ► Beep Volume

Trackball The trackball is the main interactive tool used to position image graphics and text, and make selections from onscreen menus. You can use the trackball in conjunction with the keys and controls located on the control panel, including menu selections.

Trackball.

3 - 6

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Trackball Assignment When a particular function is active, the system assigns the trackball to a specific task. The active tool or function currently under trackball control is represented by a highlighted icon on the lower right of the screen. The system may display additional icons for previously activated tools or functions. You can reassign the trackball to another tool or function by selecting the related trackball icon on the image screen or by pressing the SELECT key on the control panel (when multiple icons are displayed on the image screen). Note: The system cannot assign the trackball to more than one tool or function.

Trackball Icon

Trackball Assignment (when highlighted) Positioning the A-mode cursor or M-mode cursor Positioning of measurement markers Selecting the frame in CINE for review Positioning inflection points on a map Selecting menu items (trackball pointer) Adjusting the width of the image

Adjusting the position of the image

Positioning the image with the Offset function

Positioning a cursor for text annotation, including arrow placement

Selecting pictograms

Positioning the Region of Interest (ROI) for image magnification (zoom)

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 7

3 System Controls

Select A dual-function control that activates one function when the control is pressed and another function when the control is rotated. When several functions are active, you can assign control of the trackball to any of the active functions by pressing the SELECT control.

Select.

During mixed-mode imaging, you can press the SELECT control to reassign the trackball from controlling a function for one mode (for example, 2D FOV) to controlling a function for another mode (for example, the M-mode cursor). During the measurement function, you can use the SELECT control to delete portions of a measurement. Rotating the control when a trace measurement or drawing in a patient report is active causes the system to delete the line, one dot at a time. To assign the trackball: 1. Press the SELECT control. The active function currently under trackball control is represented by a highlighted icon on the lower right of the screen. 2. To cycle through the available functions, continue to press the SELECT control. 3. Rotate the SELECT control within a function to access its corresponding settings, pages, or values.

3 - 8

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Caliper Activates the Measurement function. When you press the CALIPER key, the menu displays measurement selections appropriate for the imaging mode and exam type. The system also places the first marker in a caliper set (set of measurement markers) in the image area. The Measurement function can generate a patient report for exam types with a report. Use the system presets to automatically activate the Measurement function each time you press the FREEZE key.

Caliper.

System Reference System Presets

Ch 3

F6 Default Settings ► Automatic Freeze Response

Freeze Freezes the image or sweep on the screen. If an image or sweep is already frozen, pressing the FREEZE key restores real-time imaging. Use the system presets to change the response of the FREEZE key to activate the CINE function or the Measurement function. Other assignments for this key include text annotation or pictograms.

Freeze.

Pedal 1 on the footswitch is programmed with the same functionality as the FREEZE key.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 9

3 System Controls

Selection and Entry Keys The ESCAPE and SET keys are located in close proximity to the trackball and provide additional functionality to the trackball and SELECT control for interacting with onscreen information and objects.

Escape Exits the currently displayed mode, function, or page and reactivates the previous mode, function, or page. Pressing the ESCAPE key, while in the Measurement function, exits the function and erases all measurements.

Escape.

Set The SET key confirms the selection of a specific function or command. For example, you can use it to anchor calipers, select a menu item or image graphic, cycle through certain menu settings, include a measurement value in a patient report, or delete a measurement from the worksheet. When used with the trackball, the function of the SET key is similar to a mouse-modeclick in the system's Windows®-based technology.

Set.

Menu Displays menu selections on the left of the screen for the active mode or function. Menu.

3 - 10

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

2D-Mode and M-Mode Imaging Controls Use the imaging controls to activate an operating mode, change the image orientation, or modify the sweep display.

2D A dual-function control that activates one function when the control is pressed and another function when the control is rotated. Pressing the 2D control activates 2D-mode for grayscale imaging. If a mixed mode or imaging function is active, pressing 2D causes the system to exit the mode or function and return to 2D-mode.

2D.

Rotating the 2D control changes the overall gain for the active mode. Rotating the 2D control clockwise increases the gain; a counterclockwise rotation decreases the gain. The range for gain settings is from 0 dB to 40 dB. When combined with the DGC controls, a gain range of –15 dB to 55 dB is possible.

Split Creates side-by-side images from one 2D-mode image. The two images are simultaneously frozen or real-time. Certain post-processing imaging parameters can be changed in the right image, allowing you to compare the effects of different image settings on an anatomical structure.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

Split.

3 - 11

3 System Controls

Dual/Select Activates Dual-mode, which displays two separately acquired images, side-by-side. The DUAL/SELECT control consists of a set of two keys. The left key displays an image on the left side of the screen. The right key displays an image on the right side of the screen. Use either key to initiate Dual-mode. Only one image can be active at any one time. The active image is indicated by the lighting intensity of the selected key and by the brightened active image indicator that displays on the image screen. The DUAL/SELECT control can be used to toggle the active image. Pressing the left key activates the left image and freezes the right image. Pressing the right key activates the right image and freezes the left image.

Dual/Select.

Active Image Indicator.

Note: The system displays a full screen image when the key for the active image is pressed. The system restores the side-by-side display when this key is pressed again.

Most imaging parameters can be changed independently.

4B Activates 4B-mode which displays four separately acquired 2D-mode images. Only one image is active at a time. The active image is indicated by the brightened active image indicator. Pressing the 4B key displays the first image on the upper left side of the screen. Pressing the FREEZE key freezes the active image and displays the next image. A total of four images can be displayed. Press the 4B key repeatedly to cycle through and activate images.

4B.

Most imaging parameters can be changed independently. For software versions 2.0 and higher: Pressing the 4B key when the (DIMAQ) Image screen is displayed activates simultaneous display of marked images.

3 - 12

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

M Activates M-mode. Pressing the M control displays an M-mode cursor in a 2D image. You can then roll the trackball to place the cursor in the area of interest. Pressing M a second time displays 2D/M-mode.

M.

L/R Flip Changes the scan direction of the active transducer. The image can be acquired from right-to-left or left-to-right. Pressing L/R FLIP while pressing and holding the Shift key on the keyboard rotates the image 90 degrees in the clockwise direction.

L/R Flip.

The location of the active image indicator defines the direction of scanning. For software versions 2.0 and higher: Pressing the L/R FLIP key when the (DIMAQ) Image screen is displayed marks the selected image for simultaneous display.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 13

3 System Controls

Image Parameter Controls Transducer Activates a transducer. Press TRANSDUCER repeatedly to cycle through the transducers connected to the system. The name of the active transducer displays on the screen.

Transducer.

MultiHertz Changes the transmit frequency of an active multi-frequency transducer in all modes. Push the MULTIHERTZ control to cycle through the available frequencies. Pushing the control up increases the frequency, and pushing the control down decreases the frequency.

MultiHertz.

DGC Increases or decreases the received gain for the depth of view. The receiver gain range is depth-dependent for the active transducer frequency. The system can display a graphic representing the DGC curve on the image screen. Use the system presets to select the length of time that the DGC graphic displays on the image screen. The 2D control also affects system gain.

DGC Control. F6 Display ► DGC Curve Display General ► DGC Invert with Image Invert

3 - 14

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Depth/Zoom A dual-function control that activates one function when the control is rotated and another function when the control is pressed and then rotated. Rotating the DEPTH/ZOOM control changes the imaging depth. Use the system presets to assign the direction of rotation (clockwise or counterclockwise) for increasing a value when using the DEPTH/ZOOM control. This assignment affects both the depth and zoom parameters. The depth scale displays in millimeters (mm), and the current depth setting displays on the lower left of the image screen.

Depth/Zoom. System Reference System Presets

Ch 3

Pressing DEPTH/ZOOM activates a zoom window in the image, initiating the magnification process. Zoom is available in real-time or when the image is frozen. Rolling the trackball positions the zoom window over the region of interest (ROI). Rotating DEPTH/ZOOM adjusts the size of the window. Pressing DEPTH/ZOOM again magnifies the selection. To exit zoom, press the 2D control. When Zoom is activated, the ROI of a real-time or frozen image can be moved by rolling the trackball.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

F6 Customize Keys ► Zoom/Depth Direction

3 - 15

3 System Controls

Focus The FOCUS control positions the transmit focal zones in the image. One, two, or four focal zone markers can be positioned at the same time. Note: When two or four focal zones are used, a reduction in frame rate occurs. The amount of reduction depends on the depth of view and the transducer in use.

Push the FOCUS control up or down to position the focal zone markers that represent the focal zone locations. One (1)

Focus.

You can position the marker throughout the field of view. Two (2) The spacing between the two focal zones adjusts automatically. Four (4) The FOCUS control adjusts the relative position of the focal zone markers within the field of view. The spacing between the focal zones adjusts automatically.

3 - 16

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Pictograms and Annotation Use the pictogram and annotation controls to display text and graphics depicting anatomical structures onscreen.

[2] Instructions for Use Annotations Pictograms

Ch A1 Ch A1

Text Allows access to tools for positioning, entering, and editing text on the image screen. You can enter text from the keyboard or select from a set of descriptive anatomical terms on the onscreen menu. Press the TEXT key to display a cursor on the screen for direct text entry using the keyboard. To reposition the text cursor, roll the trackball. To display the terms assigned to the current exam type, press the MENU key. Roll the trackball to the required term and then press the SET key. Press the ESCAPE key to remove text displayed on the screen.

Text.

System Reference System Presets

Ch 3

Use the system presets to customize the text assigned to an exam type. F6

Pictogram Pictograms are onscreen anatomical graphics that indicate the anatomy

under evaluation and the orientation of the transducer. Pictograms can also be included in patient reports for some exam types.

Default Settings ► Pictogram List ► Text Annotation

Pressing the PICTOGRAM key displays the pictograms assigned to a specific exam type on the screen. Use the system presets to customize the pictograms assigned to an exam type.

Pictogram.

To select a pictogram, roll the trackball to position the pointer on the required pictogram and then press the SET key. Press the ESCAPE key to remove the pictogram displayed on the screen. Some pictograms contain a transducer marker. Use the SELECT control to rotate the transducer marker. To reposition the marker, roll the trackball. To anchor the marker, press the PICTOGRAM key again.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 17

3 System Controls

Documentation Controls Use the documentation controls to access recording devices for printing, storing, or retrieving images and imaging parameters.

F6 Customize Keys

Print Store Stores or prints the displayed image or report to the destination configured in system presets. Use the system presets to assign functionality to this control. For example, you can configure the control to:

Print Store.

Send onscreen information to an installed documentation device, such as the black and white printer.

Digital Store 1 Stores or prints the displayed image or report to the destination configured in system presets. Use the system presets to assign functionality to this control. For example, you can configure the control to:

Digital Store 1.

Send onscreen information to an installed documentation device, such as the black and white printer. Activate the TGO (Tissue Grayscale Optimization) optional feature. Store clips. (Requires the Clip Store optional feature.)

Digital Store 2 Stores or prints the displayed image or report to the destination configured in system presets. Use the system presets to assign functionality to this control. For example, you can configure the control to:

Digital Store 2.

Send onscreen information to an installed documentation device, such as the black and white printer. Activate the TGO (Tissue Grayscale Optimization) optional feature. Store clips. (Requires the Clip Store optional feature.)

3 - 18

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Review Accesses the DIMAQ-IP feature to view images and reports, either during a patient examination or from saved studies. Review.

Special Function Controls CINE Activates the CINE function and displays CINE menu selections. Use the system presets to automatically activate the CINE function each time you press the FREEZE key.

CINE. System Reference System Presets

Ch 3

F6 Default Settings ► Automatic Freeze Response

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 19

3 System Controls

Alphanumeric Keyboard Use the alphanumeric keyboard for entering patient data, selecting an exam type, annotating clinical images, and configuring the system presets. The keyboard is arranged like a standard computer keyboard. A description of the function keys and other special keys follows.

Shortcut Keys The system supports "shortcuts" through combining keys on the keyboard. To use a shortcut, press and hold the first key and then press the second key. For example, to use the shortcut Ctrl+U, press and hold the Ctrl key and then press the U key. Use the system presets to activate functions without using shortcuts (not available for all functions). Shortcut (Key Combination) 1

Function

Ctrl+D

During the measurement function, activates the Delete feature for removing measurements from the screen.

Ctrl+M1

During the measurement function, activates the Modify feature for editing measurements.

Ctrl+P

Hides or displays patient information on the screen.

Ctrl+U1

[2] Instructions for Use Measurements and Calculations Ch B1 System Reference System Presets

Ch 3

F6 Patient ID ►Hide Patient Demographic DIMAQ Utility ►Autoprint Images

Enables or disables automatic printing of the displayed image to the selected USB printer when you store the image to the ultrasound system's hard disk using a documentation control. Note: Use the system presets to install printers, select printers, and enable or disable automatic printing.

During the measurement function, removes the label assignment from the last measured value (activates the Undo feature).

1

Requires software version 2.0 or higher

3 - 20

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Special Characters The system supports some language's special characters through the use of a combination of keys on the keyboard. The ALT key located on the left side of the keyboard accesses the special characters located on the upper right of a key. The SHIFT key located on the left or right side of the keyboard accesses the special characters located on the upper left of a key. German Character

French Key Combination

Character

Key Combination

Ä

ALT p

Ç

ALT n

ä

ALT -

ç

ALT j

ö

ALT 0 (zero)

à

ALT z

Ü

ALT [

è

ALT x

ü

ALT =

é

ALT s

ß

ALT '

ù

ALT b

Spanish Character

Italian Key Combination

Character

Key Combination

¡

ALT 1

à

ALT z

¿

ALT /

è

ALT x

Ñ

ALT I

é

ALT s

ñ

ALT 9

ì

ALT c

á

ALT a

ò

ALT v

é

ALT s

ù

ALT b

í

ALT d

ó

ALT f

ú

ALT g

Scandinavian Character

Other Key Combination

Character

Key Combination

Æ

ALT m

Œ

ALT u

æ

ALT k

œ

ALT 8

Ø

ALT . (period)

α

ALT q

ø

ALT ;

β

ALT w

Å

ALT ,

µ

ALT e

å

ALT l

θ

ALT r

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 21

3 System Controls

Function Keys The F keys located in a row across the top of the alphanumeric keyboard are called function keys.

F1 – New Patient Displays the first page of a new Patient Data entry form.

F2 – Report Displays the patient report if one is available for the current exam type. You can view, edit, or print the report.

F3 – Patient Data Displays the Patient Data form currently in use. You can view or edit the page.

F4 – Patient Browser Accesses the DIMAQ-IP feature to view images and reports, either during a patient examination or from saved studies.

F5 – Exam Displays a list of available system-defined exam types and user-defined QuickSets.

3 - 22

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

F6 – Preset Menu Displays the first page of the Preset Main Menu. Use the system presets to modify and customize the system, including general settings, QuickSets, image annotation, and calculation settings. You can use the F6 key to exit the system presets.

F7 –

(Task Light)

Illuminates the keyboard using lights on the underside of the monitor.

F8 – QuickSet Accesses the screen for saving, deleting, and overwriting QuickSets (a configuration of imaging settings for a specific transducer and exam type).

F9 – Arrow Places an arrow on the screen. Roll the trackball to reposition the arrow. Press the SET key to anchor the arrow's position.

F10 – Home Places the text cursor in the Home position (as defined with the F9 key) when the Annotation function is active.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 23

3 System Controls

F11 – Home Set Sets the default location of the text cursor. After pressing the TEXT key on the control panel, roll the trackball to place the text cursor on the image screen in the desired location and then press the F11 key. When the HOME key on the keyboard is pressed, the system places the text cursor in the position defined with the F11 key.

F12 – Delete Word Removes the most recently added term from the screen.

F13 – Hide Text Hides annotations. Press F13 again to display the annotations.

F14 – Clear Screen Deletes all text annotation displayed in the image area. Pressing the F14 key does not delete pictograms.

F15 – Biopsy Displays biopsy/puncture guidelines on the image screen for specific transducers and provides system selections for selecting and modifying the guidelines. Use the system presets to enable the Biopsy function to automatically activate when an exam type is selected. You can use the F15 key to exit the Biopsy function.

3 - 24

F6 Default Settings ► Biopsy

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Other Alphanumeric Keys Arrows Repositions the text cursor in the direction shown on the arrow key.

Alt Accesses special characters on the upper right of the keys located on the keyboard.

Backspace Deletes one character at a time from right to left during text entry. Deletes lines of completed text, one at a time. (You must press and hold the BACKSPACE key.)

Caps Lock Locks all keyboard letter keys in upper case.

Ctrl For software versions 2.0 and higher: When used in a shortcut (key combination), activates the related function. For example, when used in the shortcut Ctrl+U, enables or disables automatic printing of the displayed image to the selected USB printer (when you store the image to the ultrasound system's hard disk using a documentation control).

[1] Instructions for Use Shortcut Keys

3-20

Enter Accepts entered data.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 25

3 System Controls

Shift Accesses the upper-case letters and the character on the upper left of a key located on the keyboard.

Space Bar Inserts a blank space.

Tab Moves the cursor to the beginning of the next available entry field in the Patient Data form or a patient report.

Video I/O Displays a video signal that originates from an outside source, such as a VCR, on the system monitor. Use the system presets to select the video input source.

System Reference System Presets

Ch 3

F6 Peripheral

3 - 26

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Footswitch Use the optional footswitch as an alternative to operating keys on the control panel. Pedal 1 is assigned to the Freeze/Unfreeze function; pressing this pedal is equivalent to using the FREEZE key on the control panel. Use the system presets to assign Pedal 2 to one of the following functions:

System Reference System Presets

Ch 3

Print to a black and white printer. Store to the system's hard disk.

F6

Store clips to the system's hard disk.1

Customize Keys ► Pedal 2 function

Menu Selections The system displays onscreen menu selections for the active mode or function on the left of the screen when you press the MENU key.

Transmit Power Selections You can access the transmit power selections from the 2D-mode Imaging menu or the M-mode Imaging menu. Selection

Description

Settings

Tx Power

Increases the transmit power level and the

0 dB to –20 dB or 100% to 10%

Decreases the transmit power level and the corresponding acoustic pressure delivered through the transducer to the patient.

0 dB to –24 dB or 100% to 6%

corresponding acoustic pressure delivered through the transducer to the patient.

Tx Power

1

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 27

3 System Controls

2D-Mode Selections Selection

Description

Settings

TGO

Automatically optimizes the overall field of view (FOV) image brightness uniformity by changing the DGC, overall gain, and lateral gain.

On, Off

Re-activates TGO (Tissue Grayscale Optimization).

---

Specifies an offset value for preferred image brightness with TGO during an examination (for the current exam type and transducer). The selected value represents the increments of gain adjustment to be added to or subtracted from the default setting for the optimized gain.

-40 to 40 in increments of 1

DR (Dynamic Range)

Controls the overall contrast resolution of 2D-mode images.

35 dB to 70 dB in 1 dB increments

Persistence

Creates a visible smoothing effect by maintaining more lines of image data for each frame of imaging when the setting is increased.

0, 1, 2, 3, 4, 5, 6, 7

Edge

Distinguishes the edges of a structure.

0, 1, 2, 3, 4, 5

Gray Map

Selects a gray (processing) map.

L, B, E, S, D, A, C

Focus

For all curved or linear transducers, selects the number of focal zones.

1, 2, or 4

TGO Refresh TGO Gain

1

Use the FOCUS control on the control panel to position the markers. FOV/POS

Resizes and repositions the field of view using the trackball.

On, Off

A-mode

Activates or deactivates A-mode.

On, Off

Reset Map

Resets the current Gray Map curve back to the original factory position.

---

Modify Map (Processing)

Allows changes to the shape of the current Gray Map with the exception of Map L.

---

Reject

Increases or decreases the level of gray shades eliminated from the image.

0 to 64 in increments of 2

Offset

Enables horizontal and vertical scrolling of the image using the trackball.

On, Off

Steer

For linear array transducers only, steers the 2D image to the left, center, or right.

L, C, R

SynAps

Extends the focal zone.

On, Off

This selection is available for curved and linear array transducers.

1

Density

Increases or decreases the acoustic scan line density of a 2D image.

Std (Standard) or Hi (High)

Res/Speed

Increases image resolution by decreasing frame rate.

Std/Dtl/Far

Requires software version 2.0 or higher

3 - 28

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

M-Mode Selections Selection

Description

Settings

DR (Dynamic Range)

Controls the overall contrast resolution of M-mode sweep.

35 dB to 70 dB in 5 dB increments

Edge

Edge Enhancement. Distinguishes the edges of a structure.

0, 1, 2, or 3

Reject

Increases or decreases the level of gray shades eliminated from a sweep.

0 to 64 in increments of 1

Gray Map

Selects an M-mode gray map.

L, B, E, S, D, A, C

Full M

Displays a full-screen M sweep.

On, Off

Sweep Sp (Sweep Speed)

Adjusts the scrolling speed of the M-mode sweep. The unit is seconds.

2, 4, 8, 16

CINE Selections Selection

Description

Frame Review

Displays individual frames in a forward or reverse direction, in response to the trackball. Frame numbers are displayed. For M-mode, one frame of time motion data is displayed at a time. No frame numbers are displayed.

Motion Review

Displays CINE data in a continuous, forward direction. Reverse motion is not available.

Edit Start Edit End

Defines new beginning and ending points of a loop of CINE data.

Edit Reset

Resets the beginning and ending points to their originally acquired positions.

Align

Synchronizes the CINE display of the dual images during Dual mode.

Rate

Changes the speed of CINE review while in Motion Review.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 29

3 System Controls

Selections for 2D-Mode Measurements and Calculations Selection

Description

%Stenosis

Perform a % stenosis calculation based on the area or diameter of the same vessel.

Volume

Perform a volume measurement in either two planes or one plane. Measurement methods available for calculating a volume in two planes are: LxDxW, Ellipse, and Trace. Measurement methods available for calculating a volume in one plane are: LxD, Ellipse, and Disc.

Area

Calculates the area using Ellipse or Trace method.

A/B Ratio

Ratio of measurements. The system calculates the ratios A/B, B/A and (A-B)/A from the 2D-mode measurements: distance, area, or volume.

Angle

Determines the angle using two lines you place on the image. The lines must connect or intersect.

Distance

Simple linear measurement between two points.

Ellipse

Elliptical measurement. The system determines one diameter using the end points of the ellipse and calculates the second diameter.

Trace

Free hand trace method. Roll the trackball to delineate an area. The system determines the circumference and area using the trace segments.

2Pl Trace

Calculate volume by manually tracing structures in two planes.

1Pl Disk

Calculate a one-plane volume using the trackball to trace a structure and then positioning an axis line to be used for an assumed dimension in a second plane.

2Pl Ellipse

Calculate volume by measuring an ellipse in two planes.

2Pl LxDxW

Calculate volume by measuring length and depth in one plane and width in a second plane.

1Pl Ellipse

Calculate volume by measuring an area with an ellipse and identifying the axis common to both planes.

1Pl LxD

Calculate volume by measuring length and depth in one plane and assuming the same dimensions in the second plane.

Vol Ratio

Calculate ratios A/B, B/A, and (A-B)/A for volume.

Area Ratio

Calculate ratios A/B, B/A, and (A-B)/A for area.

Dist Ratio

Calculate ratios A/B, B/A, and (A-B)/A for distance.

Trace Length

Trace distance measurement between two points.

A-% Stenosis

Calculate area % stenosis, comparing cross-sectional areas of the same vessel.

D-% Stenosis

Calculate diameter % stenosis, comparing diameters of the same vessel.

Thyroid

Calculates thyroid volume.

Residual Incr Vol

Calculates a micturated volume by subtracting a post-void volume from a pre-void volume.

1

Calculates a volume of the prostate based on a series of area measurements. Note: Requires the Endo-P II transducer. 1

Step Vol

Calculates a volume by adding areas of slices over a length. Note: Requires the Endo-P II transducer.

1

Requires software version 2.0 or higher

3 - 30

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Selections for M-Mode Measurements and Calculations Selection

Description

Velocity

Distance over time. The measurement is determined by two distance measurement markers.

Slope

Distance over time. The measurement is determined by two distance measurement markers.

Distance

Vertical distance between two points in the M-mode sweep.

A/B Ratio

Ratio of measurements. The ratios are A/B, B/A and (A-B)/A. Ratios can be determined for Distance, Heart Rate or Time measurements.

HR

Heart rate determined over one heart cycle in 2D/M-mode.

Time

Interval in seconds between two measurement markers.

Time Ratio

Calculate ratios A/B, B/A, and (A-B)/A for time.

Dist Ratio

Calculate ratios A/B, B/A, and (A-B)/A for distance.

Selections for All Measurements and Calculations When the Measurement function is active, you can access these selections by selecting Other from the top of the menu. Selection

Description

Meas

Displays the Measured Results on the left of the screen.

Meas Pos

Specifies the position of the measurement.

Undo

Removes the last measurement from the screen and the report.

Modify

Activates the Modify feature for editing measurements.

Delete

Activates the Delete feature for removing measurements from the screen. The values of the removed measurements remain in the Measured Results and in the patient report.

Delete All

Removes all measurements from the screen. The values of the removed measurements remain in the Measured Results and in the patient report.

Biopsy/Puncture Selections For software versions 2.0 and higher: The Biopsy menu provides specific selections for the Endo-P II transducer.

[2] Instructions for Use Biopsy Menu Selections for Endo-P II

Ch A4

Selection

Description

Reset Angle

Restores the original position of the biopsy/puncture guidelines.

Guide

Selects biopsy guidelines On or Off.

Angle Adjust

Finely adjusts the angle of the biopsy/puncture guidelines.

Dot Interval

Selects dot sizes to represent guidelines.

Display cm

Displays centimeter markings (numbers) indicating depth along the guidelines.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 31

3 System Controls

Selections in DIMAQ-IP (Patient Data Management) Study Screen

DIMAQ-IP

In the upper half of the Study screen, the system displays all studies that are saved on the currently selected disk in the Disk section of the screen. The columns displayed in the upper half of the screen include Patient Name, Patient ID, Date/Time, Images, Clips1, Archived, and MBytes.

System Reference DICOM selections

Ch 6

On the upper right of the Study screen, the system displays the utilized capacity and the total capacity of the selected disk (HD or CD). The system also displays the size of the selected studies (when multiple studies are selected). On the upper left of the Study screen, the system indicates the number of studies displayed (and the total number of studies). You can select multiple studies for export, import, or deletion. In the CD section of the Study screen, the system indicates system recognition of the inserted CD (for example: Ready) and displays a graphic indicating used space on the CD. If the CD is inserted, then the system also displays a Summary sub-section (within the CD section) indicating the number of TIFF-formatted and DICOM-formatted images on the CD. For software versions 2.0 and higher: The Summary sub-section (within the CD section) indicates the number of TIFF- and AVI-formatted images/clips and the number of DICOM-formatted items on the CD. If the DICOM option is installed on the ultrasound system, then additional selections display on this screen. Study Screen Selection

Description

Hide Studies

Limits the display of studies to those newer than the age selected in the drop-down list (for studies on hard disk only).

Change Screen Image Screen

Displays the Image screen with the images from the selected study.

Worklist Screen

(Requires the DICOM option) Displays the Worklist screen.

Procedure Screen

Reserved for future use.

Live Screen

Exits the Study screen and the Review function; redisplays the real-time imaging screen.

DICOM Screen

(Requires the DICOM option)

Displays the DICOM screen.

1

Requires software version 2.0 or higher

3 - 32

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Study Screen Selection

Description

Search for Studies Search...

Displays a dialog box for entry of patient name, ID, and/or study date and then searches the currently selected disk for matching studies.

Show All

Displays all studies that are stored on the currently selected disk.

HD

Lists studies on the system's hard disk.

CD

Lists studies on the inserted compact disk (CD).

Export

Copies the selected study from the system's hard disk to a CD. This selection is available when the Disk selection is HD, a CD is inserted, and a completed study is selected. The current study can also be selected.

Import

Copies the selected study from a CD to the system's hard disk. This selection is available when the Disk selection is CD, a CD is inserted, and a completed study is selected.

Eject

Ejects the CD.

Load

Closes the CD tray.

Finalize

Prevents additional storage to the currently inserted CD.

Export format (displayed for HD only)

Specifies the format(s) of exported images:

Disk

CD

Tiff/AVI1 exports images in the "Tagged Image File Format" (TIFF) format and clips in the AVI (audio-video interleave) format. TIFF2 exports images in the "Tagged Image File Format" format. DICOM exports images in the DICOM (Digital Images and Communications in Medicine) format. Note: DICOM-formatted data cannot be imported from CD to the system's hard disk. If you plan to import data that you are archiving onto a CD, then select the Tiff/AVI check box to archive Tiff-formatted images and AVI-formatted clips.

Study New

Creates a new study by re-registering the patient listed in the selected study. If a patient is already registered, the system first prompts you to close the current study.

Close

Closes the selected study.

Delete

Removes the selected study from the hard disk. Studies on a CD cannot be deleted using the DIMAQ-IP Study screen.

Network Send

(Requires the DICOM option)

Copies the images from the selected study to the destination selected from the drop-down list. (drop-down list)

Lists the available destinations (printer layout pages and storage servers).

1

Requires software version 2.0 or higher

2

For software versions below 2.0

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 33

3 System Controls

Image Screen

DIMAQ-IP

Note: In this chapter, the term "Image screen" refers to a screen with the DIMAQ-IP option. In other chapters of the Operating Instructions, the use of "image screen" refers to a typical image screen that displays real-time images as they are acquired.

At the top of the Image screen, the system displays the Patient Name, Patient ID, and Date/Time of the study containing the displayed images.

[2] Instructions for Use Example of typical image screen Ch A2 System Reference

For software versions below 2.0: Also at the top of the Image screen, the system indicates the current page number and the total number of pages (for example, "1/2" indicates that the system is displaying the first of two pages).

DICOM selections

Ch 6

If the DICOM option is installed on the ultrasound system, then additional selections display on this screen. Image Screen Selection 1

Description

Slideshow

Enables automatic sequential viewing of images.

1 x 1, 2 x 2, 3 x 3, 4 x 4, 5 x 5 (drop-down list)

Changes the layout format (number of images per page) to the selected number. Note: 5 x 5 is not available for software versions below 2.0.

When enabled (checked), locks the selected layout format until system shutdown. When disabled (unchecked), the system optimizes the display format to fit the number of images contained in the selected study onto one page. BW Print

(Requires the DICOM option)

Sends the selected image to the DICOM BW Printer Layout page. Delete Options

Removes the selected image from storage. 2

Clip Speed2

Accesses a dialog box for enabling simultaneous clip playback and configuring sequential viewing (slide show capability). Adjusts the playback speed of all clips in the selected study.

Close Study

Completes the current patient examination and displays the Study screen.

Procedure Screen2

(Requires the DICOM option)

Displays the Choose procedure screen for selection of another procedure for the currently registered patient. Study Screen

Displays the Study screen.

Live Screen

Exits the Image screen and the Review function; redisplays the real-time imaging screen.

DICOM Screen

(Requires the DICOM option)

Displays the DICOM screen. Previous

Displays the previous page of images and automatically selects the last image on that page.

Next

Displays the next page of images and automatically selects the first image on that page.

1

For software versions below 2.0

2

Requires software version 2.0 or higher

3 - 34

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Image Screen Selection 1

Description Displays the first frame of the selected clip.

1 1

1

Displays the previous frame of the selected clip.

Stops playback of the clip.

1

Starts playback of the clip. 1

Displays the next frame of the selected clip.

Options Dialog Box (Requires software version 2.0 or higher) The system displays the Options dialog box when you select Options from the Image screen. In the table below, titles of sections are indicated in brackets ([]). Selection

Description

[Clip Playback] Play Only Selected Clip

Disables simultaneous playback of all clips in the currently displayed study.

Play All Clips

Enables simultaneous playback of all clips in the currently displayed study.

[Slideshow]

1

Slideshow on

Configures clips and images for sequential viewing in the currently displayed study.

Image Period (sec)

Specifies the length of display for each image.

Clip Play Loops

Specifies the number of times each clip is played back.

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 35

3 System Controls

DICOM Screen Selections The following descriptions for the Study, Image, and DICOM screens are specific to the DICOM Connectivity option. DIMAQ-IP Study and Image screen selections are also available for use with this option.

System Reference Study screen Image screen

Ch 4 Ch 4

In the Network section of the Study screen, the system indicates the connection status (for example: Ping OK).

Study Screen Study Screen Selections

Description

Change Screen DICOM Screen

Displays the DICOM screen for access to printer layout pages and print and store queues.

Worklist Screen

Displays the Worklist Search screen to select a scheduled procedure for either a new study or the current study (different accession number). Note: This selection is available when the Worklist option is installed and the Worklist server is configured.

Procedure Screen1

Displays the Choose procedure screen to select a scheduled procedure for the current study (same accession number). Note: This selection is available when a connected Worklist server contains multiple procedures (same accession number) for the current study.

Network

1

Send

Copies the images from the selected study to the destination selected from the drop-down list.

(drop-down list)

Lists the available destinations (printer layout pages and storage servers).

Requires software version 2.0 or higher

3 - 36

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Image Screen On the left of the Image screen, the system indicates the number of images on the printer layout page and the number of images required to fill the page. For example, "1/4" indicates that one image has been sent to the printer layout page and that four images are required to fill the layout page. Image Screen Selections BW Print

Description Sends the selected image to the DICOM BW Printer Layout page.

DICOM Screen The DICOM screen displays layout pages for the black and white printers and queue status pages for the DICOM print and store functions.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 37

3 System Controls

Printer Layout Pages The system displays the DICOM BW Printer Layout page tab at the top of the DICOM screen. The selections available for the printer layout pages are described below. The system also lists the following settings at the top of each page: setup alias, film size, number of copies, and film orientation (Portrait or Landscape); these settings are only selectable in the system presets.

System Reference System Presets

Ch 3

F6 DICOM ► Black and White Printer

Selection

Description

Delete

Removes the outlined image from the layout page.

Cut

Marks the outlined image for rearranging.

Paste

Inserts the cut image in place of the paste image.

1x1 1x2 2x2 2x3 3x2 3x3 3x5 4x5 4x6 5x6 Print Page

Identifies the columns and rows needed to assemble a full page of print images. This setting (Display Layout) is selected separately in the system presets for each type of printer and cannot be changed from a layout page.

Sends the current page of images to the DICOM Print Queue. The Display Layout requirements do not need to be filled to print the page.

Print All Pages

Sends all pages of images to the DICOM Print Queue.

Back

Displays the Study screen.

Change

Displays a dialog box for change of printer selection, film size, number of copies, and print orientation.

Previous

Displays the preceding page of print images. Not available if no preceding page exists.

Next

Displays the next page of print images. Not available if no following page exists.

1/2

3 - 38

Identifies the active page over the total number of pages.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 System Controls

Print and Store Queues Page tabs displayed along the top of the DICOM screen include:

System Reference System Presets

DICOM Print Queue

Ch 3

DICOM Store Queue The system lists the following items for each entry in the DICOM Print Queue:

F6 DICOM ► Black and White Printer ►► Write Timeout in Seconds

Patient Name Printer Time Sent No of Copies No of Sheets Status Details1, Errors Details2 The system lists the following items for each entry in the DICOM Store Queue: Type Patient Name Server Time Sent MBytes State Status Details1, Errors Details2 The selections available for the print and store queue status pages are described below. Selection

Description

Back

Displays the Study screen.

Refresh Queue2

Updates the status of each entry in the queue.

Retry Job

Attempts to resend the selected queue entry.

Delete Job

Deletes the highlighted queue entry. You can select and delete multiple queue entries.

1

Requires software version 2.0 or higher

2

For software versions below 2.0

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

3 - 39

3 System Controls

3 - 40

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup Initial Setup......................................................................................................... 3 Daily Checklist ............................................................................................... 3 System Review ............................................................................................. 4 Moving the System ............................................................................................ 8 Swivel Locking Brake .................................................................................... 9 Prior to the Move......................................................................................... 10 During the Move.......................................................................................... 10 Shipping the System ................................................................................... 11 After the Move ............................................................................................ 11 System Startup................................................................................................. 12 Plugging in the System................................................................................ 12 Supplying Power to the System .................................................................. 13 Adjusting Controls on the Monitor............................................................... 14 Connecting and Disconnecting Transducers................................................ 15 Protective Transducer Holder ............................................................... 17 Array Transducers ................................................................................ 19 Mechanical Sector Transducers ........................................................... 20 Connecting System Accessories ................................................................. 21 Footswitch ........................................................................................... 21 Input/Output Panel Connections .......................................................... 22 Accessory Outlet Panel ........................................................................ 23 Configuring the Documentation Controls ............................................. 26 General System Settings................................................................................. 27 Modifying Hospital or Clinic Name .............................................................. 27 Setting System Date and Time.................................................................... 28 Software Installation........................................................................................ 30 Loading System Software ........................................................................... 30 OS-System Disk ................................................................................... 32 Software-Based Option Installation ............................................................... 34

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 1

4 System Setup

4 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Initial Setup After your ultrasound imaging system is initially unpacked and installed, including any transducers and system options, such as the black and white printer or footswitch, you must verify system operation.

System Reference Printer Installation

Ch 5

Note: The monitor filter option includes an installation procedure.

Each day before you use the ultrasound system, perform the Daily Checklist procedures described below.

Daily Checklist Perform the following each day before using the ultrasound system: Visually inspect all transducers. Do not use a transducer with a cracked, punctured, or discolored casing, or a frayed cable. Discoloration Exception: The use of Cidex OPA and Gigasept FF disinfectants may cause discoloration of transducer housings. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

[1] Instructions for Use Approved List of Disinfectants

Ch 2

Visually inspect all power cords. Do not turn on the power if a cord is frayed or split, or shows signs of wear. If your system's power cord is frayed or split, or shows signs of wear, contact your Siemens service representative for power cord replacement. Verify that the trackball, DGC slide controls, and other controls on the control panel are clean and free from gel or other contaminants. Once the system is powered on: Visually check the on-screen displays and lighting. Verify that the monitor displays the current date and time. Verify that the transducer identification and indicated frequency are correct for the active transducer.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 3

4 System Setup

System Review

1

1

2

2

6

3 4 5 6

3

User-adjustable monitor Back-lit control panel with alphanumeric keyboard Front handle Compact Disk (CD R/W) drive Input/Output panel Transducer and gel holders

4

5

Example of the ultrasound system, left front view.

4 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

6

1

5

1

2

2 3 4 5 6

Transducer cable hanger Transducer ports Swivel wheel with brake Air filter Transducer holders Power (partial) on/off ( ) switch

4

3

Example of the ultrasound system, with standard array transducer ports, right front view.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 5

4 System Setup

Example of the ultrasound system, with standard array transducer ports and a standard array parking port right front view.

4 - 6

Example of the ultrasound system, with standard array transducer ports and a mechanical sector transducer port right front view.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

1

2

3

1 2

4

3 4 5 6

Monitor Accessory outlet panel Shelf Cable holder Power panel with circuit breaker Swivel wheel with brake

5

6

Example of the ultrasound system, back view.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 7

4 System Setup

Moving the System Caution: Preparations before moving the system are important to minimize potential damage to sensitive components and to avoid safety hazards. Review the moving instructions before moving the system. Caution: Do not park, or leave unattended, on a slope. Even when the rear brakes are engaged, the system may slide down a ramp.

The ultrasound system is designed to be a mobile unit. Before moving the system to another location, you must prepare for the move by powering off and securing the system.

4 - 8

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Swivel Locking Brake The ultrasound system has four swivel locking brakes.

Example of wheel with locking brake (unlocked).

Example of wheel with locking brake (locked).

To lock each wheel: Using your foot, push down on the lever (toward the "LOCK" label) to lock the brake and swivel. To release the brake on each wheel: Using your foot, push up on the lever (toward the "FREE" label) to release the brake and swivel.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 9

4 System Setup

Prior to the Move 1. Power off ( ) the ultrasound system. 2. Unplug the power cord from the wall outlet. Pull on the plug, not the cord. 3. Secure the power cord to avoid rolling the system wheels over the cord. 4. To ensure that the transducers are transported safely, remove each transducer and place it in its protective carrying case. 5. Unplug any connections from the system's input/output panel. These connections include network cables, peripheral devices (such as off-board documentation devices), and the optional footswitch. 6. Transport accessories (such as gel and CD-R disks) separately. 7. Release both the front and rear brakes.

During the Move Caution: When moving the ultrasound system, protect it from environmental changes including: moisture, winds, dirt and dust, and extreme heat or cold exposure.

[1] Instructions for Use Power Off Transducer Care

4-13 Ch 2

Caution: Avoid moving the ultrasound system on outside surfaces with loose dirt, contaminates, or standing liquids. Caution: Care should be taken to minimize shock and vibration of the ultrasound system. Avoid uneven surfaces that contain an abrupt height change or jarring surface irregularities.

You can move the ultrasound system from room to room within a facility and easily reposition the system during an examination. Be careful on inclines and uneven surfaces. The ultrasound system can be moved across pavement and other hardened parking lot surfaces. Note: The wheels of the ultrasound system must be locked when transporting by vehicle. The ultrasound system must be sufficiently anchored to the vehicle floor or walls such that it does not shift or move during transport.

4 - 10

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Shipping the System When shipping the system, perform the following tasks, as appropriate. To prepare the system for shipment over long distances or rough terrain: 1. Repack the system in the factory packaging and crate. 2. Load the system into a vehicle using a lift gate. To prevent lateral movement of the system, secure the system with cargo straps. To prevent sudden jarring of the system during transport, provide shock cushions beneath the system.

After the Move Caution: Make sure the ultrasound system has proper ventilation during operation. Do not position the system against walls or hard surfaces that would impede free ventilation around the system. Caution: Do not allow linens, bedding, and/or hanging curtain partitions to block the ultrasound system's ventilation. Caution: Obstructed fans can cause potential system overheating, system performance degradation, or failure. Caution: Brakes are most effective on a level surface. Never park the system on an incline greater than five degrees.

1. Position the system: Make sure the system is not placed against walls or fabrics that obstruct perimeter air flow to the system cooling fans.

[1] Instructions for Use Daily Checklist Brakes

4-3 4-9

2. Lock the front and rear brakes. 3. Plug in the cord: Plug the power cord into a hospital-grade or local equivalent wall outlet. 4. Power ON: Power on ( ) the ultrasound system. 5. Check the display: After the boot-up sequence is complete, verify that the image display is stable, that you can select a transducer, and that the system responds to selections made on the control panel.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 11

4 System Setup

System Startup The first step to operating the ultrasound system is to connect the system to a power source. Note: The ultrasound system has a universal power supply to support 100V~, 115V~, and 230V~ mains voltage.

[1] Instructions for Use Power Supply Requirements

Ch 6

Plugging in the System The ultrasound system has a detachable power cord. WARNING: For 115V units only: to ensure grounding reliability, connect the system only to a hospital-grade power receptacle.

1 2 3 4

Equipotential connector Power cord connector Safety Lock MAINS circuit breaker I = on = off

Example of power panel.

To plug in the system: 1. On initial system setup, select and connect the power cord and safety lock to your ultrasound system according to the installation instructions enclosed with the system shipment. Package Label

Power Cord Type

E-type

230V~

A-type

115V~, 100V~

2. Plug the ultrasound system's power cord into the power source (wall outlet). Ultrasound System's Universal Power Supply

Power Source

230V~

230V standard mains, i.e. "Schuko" receptacle (CEE 7-7 standard)

115V~

Hospital-grade MAINS receptacle

100V~

Standard 100V MAINS receptacle

4 - 12

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Supplying Power to the System The ultrasound system is powered on and off using the partial power on/off ( ) switch located on the upper left of the keyboard. This switch glows blue when the system's power is on and amber when the system's power is standby. Note: This switch does not completely shut down or disconnect the system from the power mains. This switch only powers on, or off, a portion of the ultrasound system. To completely disconnect the system from the power mains, the circuit breaker located on the back panel must be switched from I to O.

Caution: Wait approximately 20 seconds between powering the system off and then on again. This allows the system to complete its shutdown sequence.

To power on the system: 1. Before using the system, perform the Daily Checklist. 2. Verify the power cord is plugged into the system and then into the power supply.

[1] Instructions for Use Daily Checklist

4-3

3. Power on ( ) the ultrasound system. When powered on, the system runs through a series of self-diagnostic and calibration tests. The tests last approximately one minute, after which the system is ready for use. Note: The system will not run through the complete power-on routine if a problem occurs. Instead, an error code or message appears on the screen to indicate the problem. Please note the message and call your local Siemens service representative.

The system is factory-configured to display initially in 2D-mode. 4. Visually check the on-screen displays and lighting indicated in the Daily Checklist. To power off the system: Note: Always close dialog boxes and related error message and confirmation dialog boxes prior to powering off the system. This action will prevent excessive power off periods.

1. Press the power on/off ( ) switch located on the upper left of the control panel. The system displays a confirmation message. 2. Select OK or press the power on/off ( ) switch again. Wait approximately 20 seconds before powering on the ultrasound system.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 13

4 System Setup

Adjusting Controls on the Monitor The brightness control ( ) and the contrast control ( ) are located under the left, front edge of the monitor. Note: Factory-defined imaging presets were created using default settings of the brightness and contrast controls of the monitor. Adjusting the brightness and contrast controls on the monitor may affect the image optimization intended by the factory-defined imaging presets.

For consistency in image reproduction, adjustments to the brightness and contrast of the viewing monitor should be made prior to adjusting the print quality of installed documentation devices. To adjust the brightness or contrast control for the monitor: Note: Always begin adjusting your monitor with the controls set to the factory defaults, and then adjust each control separately to suit your preference and the lighting conditions in the room.

Rotate the brightness control ( ) clockwise for a brighter image with a lighter background. Rotate the brightness control counterclockwise for a darker image. Rotate the contrast control ( ) clockwise to increase the display contrast. Rotate the contrast control counterclockwise to decrease the display contrast.

To restore the factory default monitor settings for brightness and contrast: 1. Rotate the brightness control ( ) to the center (detent) position. The system restores the factory default setting for brightness. 2. Rotate the contrast control ( ) to the center (detent) position.

The system restores the factory default setting for contrast.

4 - 14

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Connecting and Disconnecting Transducers Caution: Ensure that the system is in freeze before connecting and disconnecting transducers. If a transducer is disconnected before the image is frozen, the system will display an error message, and it will be necessary to reset the system before continued use.

You can connect multiple transducers to the ultrasound system, with one transducer being the active transducer. 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

Example of standard array transducer ports.

1

Requires software version 2.0 and higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 15

4 System Setup

Example of standard array transducer ports and a standard array parking port.

Example of standard array transducer ports and a mechanical sector port.

4 - 16

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Protective Transducer Holder Caution: Transducer holders have variable sizes, both in depth and diameter. To avoid transducer damage, you must use the holder or insert provided for transducers that have small or large diameter handles or for specialty transducers, such as endocavity transducers.

After connecting a transducer to the system, place the transducer in the protective holder attached to the control panel platform. A holder can also be used for the coupling agent (gel).

Transducer Holders The transducer holders on the sides of the control panel are interchangeable and replaceable.

1 2 3 4

Point of attachment Tab Support Holder

Example of transducer holders.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 17

4 System Setup

To remove a transducer holder: 1. Reach under the holder to locate the tab on the holder. The tab extends below the point of attachment to the ultrasound system. 2. Squeeze the tab towards the holder and pull the holder downward. To install a transducer holder: Align the support on the holder directly below the point of attachment on the ultrasound system and firmly push upwards until the holder snaps into place. To assemble a transducer holder with an extension: Align the tabs on the transducer holder with the slots on the extension and push together until the extension snaps into place. You can now install the transducer holder onto the ultrasound system. To disassemble a transducer holder with an extension: Squeeze the tabs on the side of the transducer holder and pull the extension away from the transducer holder.

Transducer Cable Management After you have connected and secured a transducer, drape the transducer cable through one of the cable hangers located on the sides of the ultrasound system. These hangers provide support for the transducer cables, keep cables off the floor, and help to prevent tangling of the cables when more than one transducer is connected to the system.

4 - 18

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Array Transducers Caution: You must freeze the system before connecting or disconnecting a transducer. Note: When transducer connectors are being attached to or disconnected from the system, resistance may be encountered due to the special shielding material inside the connectors. This is normal for these transducers.

Array transducer port.

To connect an array transducer: 1. Insert the connector pins into the system port. Adjust the connector until you can turn the lever on the transducer connector clockwise to lock it in position. This secures the connector in position and ensures the best possible contact. 2. Place the transducer in the transducer holder and drape the cable through the cable hangers. To disconnect an array transducer: Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the transducer. Use the following instructions.

1. Turn the lock on the connector housing counterclockwise until it unlocks. 2. Firmly grasp the transducer connector and carefully remove it from the system port.

Example of locked and unlocked positions of the connector.

3. Store each transducer in its protective carrying case.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 19

4 System Setup

Mechanical Sector Transducers Caution: You must freeze the system before connecting or disconnecting a transducer.

Ultrasound systems for use with linear array, convex array, and mechanical sector transducers have a mechanical sector transducer port. Note: When transducer connectors are being attached to or disconnected from the system, resistance may be encountered due to the special shielding material inside the connectors. This is normal for these transducers.

Mechanical sector transducer port.

To connect a mechanical sector transducer: 1. Insert the connector pins into the system port. Adjust the connector until you can turn the lever on the transducer connector clockwise to lock it in position. This secures the connector in position and ensures the best possible contact. 2. Place the transducer in the transducer holder and drape the cable through the cable hangers. To disconnect a mechanical sector transducer: Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the transducer. Use the following instructions.

1. Turn the lock on the connector housing counterclockwise until it unlocks.

Example of locked and unlocked positions of the connector.

2. Firmly grasp the transducer connector and carefully remove it from the system port. 3. Store each transducer in its protective carrying case.

4 - 20

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Connecting System Accessories Footswitch The ultrasound system has an optional dual-pedal, watertight footswitch. To connect the footswitch to the system: Insert the footswitch connector housing into the socket located on the input/output panel.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

Footswitch label identifying the connector socket.

4 - 21

4 System Setup

Input/Output Panel Connections Video and communication connections are on the input/output panel. The input/output panel is located on the left side of the ultrasound system. 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 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 the Siemens service department or your local Siemens representative.

System Reference Accessories and Options

Ch 2

Input/output panel connections. 1 2 3 4 5 6

Video Out Printer Control connection (remote control Video In (composite) Footswitch S-Video In Video Out (VGA)

7 8 9 10 11

S-Video Out Serial Port Ethernet Connection USB Ports Status Indicators (for service diagnostics only)

The impedance of the video input to the ultrasound system must be matched to the output impedance of the peripheral device using system presets. Standard video devices have an output impedance of 75 ohms, so the video impedance is normally set to 75-ohm.

4 - 22

[ 1 ]

F6 Peripheral ►Video Input Impedance

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Accessory Outlet Panel The accessory outlet panel is located above the shelf on the back of the system. The panel has two isolated outlets (J2 and J3) and associated fuses. Both outlets are protected by fuse F1 when the Mains voltage is from 100V∼ to 120V∼; by fuse F2 when the Mains voltage is from 220V∼ to 240V∼.

Accessory outlet panel. 1 2

[ 1 ]

Fuse F1 (100V∼ to 120V∼) Fuse F2 (220V∼ to 240V∼)

I N S T R U C T I O N S

3 4

F O R

U S E

Accessory outlet J2 Accessory outlet J3

4 - 23

4 System Setup

Connecting Peripheral Equipment In order to fulfill EN 60601-1-1 and IEC 60601-1-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety) requirements, connection of peripheral equipment to your ultrasound imaging system must adhere to one of the following conditions:

System Reference Report Printers

Ch 5

The peripheral equipment itself is a medical device approved according to EN 60601-1 and IEC 60601-1, or Non-medical peripheral equipment approved according to any other EN or IEC standard (EN XXXXX or IEC XXXXX, e.g., equipment complying with EN 60348 and IEC 60348, EN 60950 and IEC 60950, etc.) must use the following setup for connection: — Connect the imaging system to an independent protective earth terminal, with a ground wire connection to the ultrasound systems equipotential connector. Ensure that the protective earth wire is connected to a qualified protective earth connection independent of the existing systems earth connection (via the power cable). — The peripheral equipment is located at least 1.5 meters (1.8 meters [6 feet] in Canada and the U.S.A.) outside of the patient environment. A patient environment is defined as the area in which medical examination, monitoring, or treatment of the patient takes place.

Equipotential connector located on power panel of imaging system.

— The peripheral equipment is connected to a main outlet outside the patient environment but still within the same room as the imaging system. For additional information and other possible combinations, please refer to the Medical Electrical Equipment Standard EN 60601-1-1 or IEC 60601-1-1, Annex BBB.7, Scenario 3c. Note: The above information is based on current EN 60601-1-1 and IEC 60601-1-1 standards, dated 2000-12. If your country's regulatory standards for medical equipment do not correspond to EN 60601-1 and IEC 60601-1 as well as EN 60601-1-1 and IEC 60601-1-1, your local requirements may be different.

4 - 24

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

Example of a Peripheral Equipment Connection and Patient Environment. 1

2 3

Patient environment (represented by dot pattern, extending exactly 1.5 meters (1.8 meters [6 feet] in Canada and the U.S.A.) around patient and ultrasound system) Ultrasound system Peripheral equipment power

4 5 6 7

Peripheral equipment (EN XXXXX and IEC XXXXX) RS-232C cable or video in/out Additional Protective Earth (refer to 4-24) Ultrasound system power

Serial Port The system has a serial port for connecting to a PC or to a serial printer. F6

Configuring the Serial Port Use the system presets to select the destination for data sent through the serial port on the ultrasound system.

Peripheral ►External RS-232C Port

Caution: Should you disconnect the RS-232C cable from peripheral equipment, always connect the termination cap to the cable connector. The termination cap protects the pins on the connector and protects the system from potential image degradation due to radio wave interference.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 25

4 System Setup

Configuring the Documentation Controls You can configure the documentation controls for printing, storing, and/or the TGO tissue grayscale optimization optional feature.

System Reference System Presets

Ch 3

For software versions 2.0 and higher: You can also configure documentation controls for storing clips. Use the system presets to configure clip options (such as length). F6

To configure the documentation controls:

Clip Capture

1. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 2. Select Customize Keys on the left of the screen. 3. For each documentation control (PRINT STORE, DIGITAL STORE 1, or DIGITAL STORE 2), select the required option: To configure the documentation control for:

Select this option:

Storage to the hard disk

Disk Store

Printing to the black and white printer

B/W Print

Printing to the DICOM black and white printer

DICOM B/W Printer

Storage to the hard disk and printing to the black and white printer

D. Store and B/W Pr.

Optimization of tissue grayscale (TGO feature)

TGO

Note: TGO is not available for the PRINT STORE key.

For software versions 2.0 and higher: Stores clips

Clip Capture

Note: This option is not available for the PRINT STORE key.

4. Select the Save button to store the new settings and exit the system presets.

4 - 26

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

General System Settings You can change general system settings such as the on-screen display of the date, time, and hospital name using the system presets. These settings display on the image screen as well as on patient reports.

System Reference System Presets

Ch 3

Note: If the setup menus are accessed when the system is in freeze, you must unfreeze the system to display the changes.

Modifying Hospital or Clinic Name To change the hospital or clinic name, enter a new name into the system preset. To change the hospital name:

F6 General ►Hospital Name

1. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 2. Roll the trackball to General on the left of the screen and then press the SET key on the control panel. 3. Roll the trackball to Hospital Name, and then press the SET key. 4. Enter a name and then press the SET key. You can enter up to 60 characters. 5. Roll the trackball to Save and then press the SET key to store the new settings and exit the system presets.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 27

4 System Setup

Setting System Date and Time The date is displayed numerically on the upper right of the image screen. You can change the system date and format and time, including time zone and daylight savings time correction.

System Reference System Presets

Ch 3

Note: To view your changes to the image screen, unfreeze the system. F6

To select the date format:

General ►Date format Day / Time ►Date ►Time

1. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 2. Roll the trackball to General on the left of the screen. 3. Roll the trackball to Month/Day/Year, Day/Month/Year, or Year/Month/Day in the Date Format area, then press the SET key on the control panel. 4. Roll the trackball to Save and then press the SET key to store the new settings and exit the system presets. To change the system date: 1. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 2. Roll the trackball to Day / Time and then press the SET key. 3. Enter the date by completing the Month, Day, and Year fields. For example, to enter March 20, 2005 in the Month, Day, Year format, enter 03 for the month, 20 for the day, and 2005 for the year. Use the TAB key to advance to the next field. Use the trackball to reposition the text cursor if you need to make a correction. 4. Activate the new settings by rolling the trackball to the Set button to the right of these fields and pressing the SET key on the control panel.

4 - 28

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

To change the system time: 1. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 2. Roll the trackball to Day / Time and then press the SET key. 3. Enter the time by completing the Hour, Minute, and Second fields. Use the TAB key to advance to the next field. Use the trackball to reposition the text cursor if you need to make a correction. 4. Activate the new settings by rolling the trackball to the Set button to the right of these fields and pressing the SET key on the control panel. 5. To adjust the time for Daylight Savings, roll the trackball to the Daylight Savings Time Adjustment (+1 Hour) check box and then press the SET key. 6. To set the time zone, roll the trackball to the Time Zone drop-down list and then press the SET key. a.

Using the SET key, scroll up or down the list until the required time zone appears.

b. Roll the trackball to highlight the required time zone and then press the SET key. 7. Roll the trackball to the Save button and then press the SET key on the control panel.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 29

4 System Setup

Software Installation You can install a software upgrade or you can reload existing software; you can also re-install the operating system (OS) on the ultrasound system. Before starting a software installation, back up user-defined settings, and the patient database, and uninstall key disk options.

[1] Instructions for Use Software-Based Option Installation 4-34 [2] Instructions for Use

Loading System Software

QuickSets

Prerequisite: If you plan to delete user-defined settings during software installation (by selecting Initialize Preset on the System/Language screen), then Siemens recommends that you make a back-up copy of user-defined settings (system presets, QuickSets, and OB tables and formulas) before beginning this procedure.

Ch A1

System Reference Saving Patient Data Ch 4 Compact Disk Drive Ch 5 Storing System Presets Ch 5

To load new system software or reload system software: 1. With the system powered on, insert the System Disk into the CD drive. a.

Press the eject button on the right of the CD drive, which is located below the control panel on the front of the ultrasound system.

b. Insert the System Disk into the CD tray and press the eject button to close the CD tray. 2. Press the F6 key on the keyboard to access the system presets. The system displays the Preset Main Menu screen. 3. Select System/Language on the left of the screen, and then select one of the following selections: Note: System/Language may appear on the second page of the Presets Main Menu. To see the second page of the menu, roll the trackball to the down arrow at the bottom of the menu and press the SET key on the control panel.

–

Select Retain Current Preset to retain user-defined settings (system presets, QuickSets, OB tables and formulas) and retain the current language selection.

–

Select Initialize Preset to delete user-defined settings (system presets, QuickSets, OB tables and formulas) and reset the language selection to the factory default. Initialize Presets also removes key disk options.

System Reference Compact Disk Drive Ch 5 Storing System Presets Ch 5

Note: Siemens recommends that you retain user-defined settings. If you select Initialize Presets, then make a backup copy of user-defined settings (system presets, QuickSets, and OB tables and formulas) before deleting user-defined settings.

4 - 30

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

4. Select the Upgrade System button to begin software installation. The software installation process takes approximately five minutes. When the installation process completes, the system displays a message indicating the install was successful prompts you to power off the system. 5. Press the eject button on the CD drive and remove the System Disk. 6. Roll the trackball to the Shut Down button in the message and press the SET key. The system screen goes dark and powers off. Wait 20 seconds before powering on the system. Note: If you selected Initialize Preset during this procedure, the system language may change. Use the system presets to select another language. To change the language, press the F6 key, select the down arrow at the bottom of the left side of the screen, select System/Language on the left of the Preset Main Menu, select another language, and then select the Change Language button. Wait for the system to power off and then press the power on/off switch to power on the system.

System Reference System Presets

Ch 3

7. Press the power on/off ( ) switch located on the upper left of the control panel to power on the system.

[1] Instructions for Use

8. To confirm the software installation:

Supplying Power to the System 4-13

a.

Press F6 to display the Preset Main Menu.

b. Select Service. c.

Confirm that the version of the system host software listed in the Product SW version matches the version of software from the System Disk.

d. Select Cancel to exit the service login window. 9. If you un-installed key disk options or initialized presets, then reinstall the key disk options.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

[1] Instructions for Use Software-Based Option Installation 4-34

4 - 31

4 System Setup

OS-System Disk Caution: Use extreme caution should you need to load software with the OS-System Disk. The OS-System Disk overwrites the ultrasound system's hard drive. Before you upgrade the software, back up preset and patient data, and uninstall key disk options.

The OS-System disk is an auto bootable CD. If inserted in the CD drive, then the disk will overwrite the local hard drive while cycling power to the ultrasound system.

System Reference Saving Patient Data Ch 4 Compact Disk Drive Ch 5 Storing System Presets Ch 5 [1] Instructions for Use Software-Based Option Installation 4-34

To load system software and DIMAQ software using the OS-System Disk: 1. With the system powered on, insert the OS-System Disk into the CD drive. a.

Press the eject button on the right of the CD drive, which is located below the control panel on the front of the ultrasound system.

b. Insert the OS-System Disk into the CD tray and press the eject button to close the CD tray. [1] Instructions for Use

2. Press the power on/off ( ) switch located on the upper left of the control panel to power off the system.The system displays a confirmation message.

Supplying Power to the System 4-13

3. Select OK or press the power on/off ( ) switch again. The system screen goes dark and powers off. Wait 20 seconds before powering on the system. 4. Press the power on/off ( ) switch to power on the system. The system displays an "R" prompt on the image screen in approximately five minutes. 5. Remove the OS-System Disk from the CD drive. 6. Press the power on/off ( ) switch to power off the system. The system screen goes dark and powers off. Wait 20 seconds before powering on the system. 7. Press the power on/off ( ) switch to power on the system. The system will boot up in approximately three minutes. If an "Extended Post" message displays, then select OK to dismiss the dialog box.

4 - 32

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

8. To confirm the software installation: a.

Press F6 to display the Preset Main Menu.

b. Select Service. c.

Confirm that the version of the system host software listed in the Product SW version matches the version of software from the OS-System Disk.

d. Select Cancel to exit the service login window. 9. To change the system language: a.

Select System/Language on the left of the screen.

Note: System/Language may appear on the second page of the Presets Main Menu. To see the second page of the menu, roll the trackball to the down arrow at the bottom of the menu and press the SET key on the control panel.

b. Select the required language and then select the Change Language button. The system screen goes dark and powers off. Wait 20 seconds before powering on the system. c.

Press the power on/off ( ) switch to power on the system.

10. Reinstall the key disk options.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 33

4 System Setup

Software-Based Option Installation You can install or uninstall a software-based option on the ultrasound system using a key disk (USB memory stick). One key disk is required for one option per system. You cannot concurrently install a key disk option on multiple systems. If subsequently uninstalled, the option key disk can be installed on a different SONOLINE G20 ultrasound system. Observe the following precautions when using a key disk: Do not power on the ultrasound system with a key disk inserted in a USB port. Insert only one key disk at a time. Do not remove the key disk during option installation or uninstallation. To install a software-based option: 1. Insert the media containing the option into one of the USB ports on the input/output panel. 2. Press the F6 key on the keyboard. The system displays the Preset Main Menu. 3. Roll the trackball to Installation from Key Disk and then press the SET key. 4. Roll the trackball to the Install button and then press the SET key. The system displays a confirmation dialog box. 5. Roll the trackball to the OK button and then press the SET key. The system displays a message box as the key disk flashes while the option is installed. When the installation is complete, the system displays a new message box. 6. Roll the trackball to the OK button and then press the SET key. The option is listed on the Installed Option screen. 7. Remove the key disk.

4 - 34

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 System Setup

To uninstall a software-based option: 1. Insert the source media for the option into one of the USB ports on the input/output panel. 2. Press the F6 key on the keyboard. The system displays the Preset Main Menu. 3. Roll the trackball to Installation from Key Disk and then press the SET key. 4. Roll the trackball to the Uninstall button and then press the SET key. The sytem verifies that the inserted source media matches an installed option and then displays a confirmation box. 5. Roll the trackball to the OK button and then press the SET key. The system displays a message box as the key disk flashes while the option is uninstalled. When the process in complete, the system displays a new message box. 6. Roll the trackball to the OK button and then press the SET key. The option is no longer listed on the Installed Option screen. 7. Remove the key disk.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

4 - 35

4 System Setup

4 - 36

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination Entering Patient Data......................................................................................... 3 Using the Patient Data Form ......................................................................... 4 Calendar Tool ......................................................................................... 5 General and Exam-Specific Clinical Data ................................................ 6 General Information All Exam Types.................................................... 6 Specific Patient Data Information OB, Early OB, GYN, and EM................................................................................................... 7 Specific Patient Data Information Cardiac............................................ 8 Specific Patient Data Information Urology ........................................... 8 Selecting a Scheduled Procedure .................................................................. 9 Searching the Worklist ......................................................................... 10 Selecting a Scheduled Procedure Using DIMAQ.................................. 12 Fields Displayed on the Worklist Search Screen .................................. 13 Fields Displayed on the Choose Procedure Screen.............................. 15 Editing Patient Data ..................................................................................... 15 Changing the Exam Type................................................................................. 16 Accessing the Exam and QuickSet List ....................................................... 16 Exam Type Abbreviations ............................................................................ 17 Activating a Transducer................................................................................... 18 Selecting an Operating Mode ......................................................................... 19 Examination Completion ................................................................................. 20 Printing a Patient Report.............................................................................. 20 Video Printer (On-board) ....................................................................... 20 Peripheral Printer (Off-board)................................................................ 20 Ending an Exam........................................................................................... 21

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 1

5 Beginning an Examination

5 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Entering Patient Data Before beginning a patient examination, you can use the keyboard to enter general patient information into the Patient Data form. You can retrieve previously saved patient information from a compact disk (CD).

[1] Instructions for Use Searching the Worklist Modifying the Hospital Name

5-10 Ch 4

You can also automatically register a new patient by pressing one of the documentation controls configured for disk storage when no patient is registered. The system opens a new study, identifying the Patient Name as an asterisk (*) and the Patient ID as the opening date and time. You can then change the patient information for the current study while the study remains open. You can automatically register a new patient by using the Worklist search function. To enter new patient information:

System Reference

1. Press the F1 function key located on the keyboard.

Selecting Images and Studies

The system displays the New Patient Data form with a text entry cursor positioned in the Last Name field.

Ch 4

Note: You can also review and edit an existing form by pressing the F3 (PATIENT DATA) key.

2. Enter the patient information using the instructions on the following pages. 3. Select OK at the bottom of the form to confirm your entries or select Cancel to discard your entries. –

To confirm your entries, roll the trackball to the OK button and then press the SET key to enter the patient information. The system displays the image screen with the new patient information.

–

To exit the form without saving the entries, select Cancel at the bottom of the form. The system redisplays the image screen with the previous patient's information and discards the entries on the new patient data form.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 3

5 Beginning an Examination

Using the Patient Data Form The Patient Data form contains general and exam-specific information. A calendar tool is available for entering date-dependent information for OB exams. To:

Perform this action:

Move the text cursor to the beginning position of the next entry field

Press the TAB key on the keyboard. You can also roll the trackball to the next field and then press the SET key on the control panel.

Delete characters

Press the BACKSPACE key on the keyboard.

Select a button or object on the form

Roll the trackball to the button or object and then press the SET key.

Save the new patient data, exit viewing/editing of the patient form, and redisplay the image screen

Roll the trackball to the OK button and then press the SET key or press the RETURN key on the keyboard.

Exit viewing/editing of the patient form, and redisplay the image screen without saving the new patient data

Roll the trackball to the Cancel button and then press the SET key.

5 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Calendar Tool You can display a calendar tool in the Patient Data form for use with OB exams.

Example of Calendar Tool.

To use the calendar tool: 1. Roll the trackball to select the down arrow (▼) on a date field of the patient data form and press the SET key to access the calendar. If a date has not been entered in the LMP field, the calendar automatically displays a date 60 days before the examination date. To confirm this date, select the OK button. To select another date, scroll through the months of the calendar. 2. To scroll through the months of the calendar, select either the back arrow (◄) or the forward arrow (►). 3. Roll the trackball pointer to a date and then press the SET key. The system exits the calendar tool and places the selected date in the Patient Data form. 4. To exit the calendar without saving changes, select the Cancel button below the calendar.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 5

5 Beginning an Examination

General and Exam-Specific Clinical Data The Patient Data form contains a Physical/Clinical History section. This section contains general data entry fields for all exam types and specific fields for the following exam types:

System Reference System Presets

Ch 3

OB, Early OB, GYN, and EM1 Cardiac

F6

Urology

General ►Date Format ►Height and Weight Format

General Information

All Exam Types

The system transfers patient information to the patient report for exam types with a report. Use the system presets to select the measurement convention for the height and weight fields and to include an operator ID and the referring physician's name in a report.

F6 M&R ►Measurement and Report Preset ►►Display Item ►►Display Configuration General ►Height and Weight Format

In this field:

Enter…

Last Name

Patient's last name.

First Name

Patient's first name.

MI

Patient's middle initial.

Accession Number

Identification code indicating the sequence of the current study as related to other studies for this patient. Used for billing purposes. Typically generated by a HIS/RIS (Worklist) server.

ID

Identification code for the patient.

DOB

Patient date of birth using the format selected in system presets. The system automatically calculates the patient age and displays the value in the AGE field.

1

Sex

Patient sex.

Referring MD

Name of the referring physician.

Physician ID

Identification of the physician.

Height

Patient height using the convention selected in the system presets.

Weight

Patient weight using the convention selected in the system presets.

Indication

Additional information.

Requires software version 2.0 or higher

5 - 6

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Specific Patient Data Information GYN, and EM

OB, Early OB, Patient Data form: OB, Early OB

In this field:

Enter...

LMP

Start date of the patient’s Last Menstrual Period.

GYN

EM1

Use the keyboard or the calendar tool to enter this date. You can also allow the system to calculate the LMP based on the EDC. A calculated LMP displays two asterisks (**) next to the date. EDC

Estimated Date of Confinement. The system automatically calculates and displays the Estimated Date of Confinement based on the LMP or IVF date. (EDC = LMP + 280 days or IVF Date + 266 days.) Use the keyboard or the calendar tool to enter this date.

IVF Date

Date of in-vitro fertilization. Use the keyboard or the calendar tool to enter this date. A calculated IVF displays two asterisks (**) next to the date.

Clinical Menstrual Age Based On

1

Basis of Clinical Menstrual Age (CMA). The system calculates and displays the CMA based on the LMP or IVF date already entered. Press the SET key to specify whether the LMP date or IVF date will be used to determine the Clinical MA.

Clinical MA

The system calculates and displays the Clinical Menstrual Age using the LMP or IVF. The Clinical MA displays in the patient report.

Gravida Para AB Ectopic

Patient history of pregnancies, entered with the number keys.

MAFP

Maternal Alpha-Fetoprotein level, up to four numbers, including an optional decimal place.

The entries in these fields are transferred to the Patient Report, but do not display on the image screen.

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 7

5 Beginning an Examination

Specific Patient Data Information

Cardiac Patient Data form:

In this field:

Enter…

SYS/DIA

Blood pressure, using the systole over diastole measurement in mmHg.

Cardiac

BSA

Patient Body Surface Area in m2. The system automatically calculates the BSA (based on Height and Weight entries) and transfers the value to the patient report. BSA is calculated with one of the following two formulas:

For height in centimeters and weight in kilograms: BSA = 0.007184 x (weight)0.425 x (height)0.725

For height in feet/inches and weight in pounds: BSA = 0.007184 x (weight x 0.454)0.425 x (height x 2.54)0.725

Specific Patient Data Information

Urology Patient Data form:

In this field

Enter…

PSA

Prostate specific antigen level in ng/ml.

5 - 8

Urology

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Selecting a Scheduled Procedure (Requires the DICOM option and the DICOM Modality Worklist option) You can select a scheduled procedure using the Worklist search method or the DIMAQ method. Note: The DIMAQ method for selecting a scheduled procedure requires software version 2.0 or higher.

To…

Use this method:

Register a new patient (automatically enter the patient data for a procedure into the New Patient Data form)

Worklist search

Select another procedure for the current study (different accession number)

Worklist search

Select another procedure for the current study (same accession number)

DIMAQ

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 9

5 Beginning an Examination

Searching the Worklist You can use the Worklist search function to select a scheduled procedure for a new study. You can also use the Worklist search function to select a scheduled procedure for the current study (different accession number). Note: If the Worklist server assigns the same accession number to procedures within a study, then use DIMAQ to select another procedure for the current study.

To search the Worklist server and begin a scheduled procedure: 1. Press the F1 function key located on the keyboard.

[1] Instructions for Use Selecting a Scheduled Procedure Using DIMAQ

5-12

The system displays the New Patient Data form with a text entry cursor positioned in the Last Name field. 2. Enter patient information for the search and then select the Worklist button.

F6

The system displays the Worklist Search screen, containing data entered on the New Patient Data form. If streamlined search is enabled, then the system begins searching procedures scheduled for the next 24 hours using data entered on the New Patient Data form.

DICOM ► Worklist Server ►► Streamlined Search

Note: To avoid retrieving patient data when selecting a scheduled procedure for the currently registered patient, select Use Cache in the Offline field of the Worklist Search screen.

3. If streamlined search is not enabled, then enter additional search criteria (if required) and begin the search: a.

Enter additional search criteria using the keyboard. To access the next field, press the TAB key on the keyboard. To remove data from the selected field, select Clear.

b. Select Search to begin the search. The system displays the search results at the top of the Worklist Search screen and activates the Scheduled Procedures field and the Select button. 4. To sort patient data: –

Select a column heading to sort the files in ascending order by heading.

–

Select the column heading again to sort in descending order.

5 - 10

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

5. To begin a new study: a.

Select a study from the top of the Worklist Search screen.

Note: When the Worklist server assigns different accession numbers to procedures within a study, the system lists each procedure separately at the top of the Worklist Search screen.

b. Select (click) the Select button. The system transfers the patient data into the New Patient Data form. c.

Use the keyboard to edit or enter data and then select OK to begin the study.

Note: The following fields cannot be edited for patient data transferred from the Worklist server: Patient Name, Patient ID, Accession #, DOB/Age, Sex.

6. To begin another scheduled procedure for the current study (different accession number): a.

Select a study from the top of the Worklist Search screen.

Note: When the Worklist server assigns different accession numbers to procedures within a study, the system lists each procedure separately at the top of the Worklist Search screen.

b. Select (click) the Select button. c.

Select OK in the confirmation message to end the current procedure.

d. Select either Completed or Discontinued in the confirmation message to indicate status of the ended procedure and to begin the selected procedure.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 11

5 Beginning an Examination

Selecting a Scheduled Procedure Using DIMAQ You can use DIMAQ to select a scheduled procedure for the current study (same accession number). Use DIMAQ if the Worklist server assigns the same accession number to procedures within a study (that is, if procedures are entered into the Worklist server using a billing model that is based on the Integrated Healthcare Enterprise [IHE] guidelines). Note: If the Worklist server assigns different accession numbers to procedures within a study, then use the Worklist search feature to select another procedure for the current study.

To select another procedure (same accession number) for the currently registered patient: Note: You must configure and activate a DICOM configuration (alias) for the MPPS server before using the Worklist search feature to select procedures.

System Reference DICOM Connectivity Option

Ch 6

[1] Instructions for Use Searching the Worklist

5-10

1. Press the REVIEW key on the control panel to display the Image screen. 2. Select the Procedure Screen button on the left of the screen to display the Choose procedure screen. Note: This selection is available when a connected DICOM Worklist server contains multiple procedures (same accession number) for the current study.

3. Select the procedure from the Scheduled Procedure(s) drop-down list and then select the Select button on the right of the screen. The system displays a confirmation message. 4. Select OK in the confirmation message to end the current procedure. The system displays another confirmation message. 5. Select either Completed or Discontinued in the confirmation message to indicate status of the ended procedure and to begin the selected procedure. 6. Select the Live Screen button to display the image screen.

5 - 12

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Fields Displayed on the Worklist Search Screen In this field:

Enter…

Scheduled Procedures

Lists available procedures for the selected study. Procedures are identified by study code and description. For software versions 2.0 and higher: Procedures are also identified by modality (US is ultrasound).

Patient Name Last name of patient.Use an asterisk (*) to indicate partially known values. For example, to search for the last name "Miller", you can enter "Mil*" or "*ler". First name of patient. Use an asterisk (*) to indicate partially known values. For example, to search for the first name "Christopher", you can enter "Chris*" or "*pher". Middle initial of patient.

Last First

Middle Patient ID

Identification code for the patient. Searching for the ID requires an exact match. 1

Performing Physician

1

Last1

Last name of performing physician. Use an asterisk (*) to indicate partially known values. For example, to search for the last name "Miller", you can enter "Mil*" or "*ler".

First1

First name of performing physician. Use an asterisk (*) to indicate partially known values. For example, to search for the first name "Christopher", you can enter "Chris*" or "*pher".

Middle1

Middle initial of performing physician.

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 13

5 Beginning an Examination

In this field:

Enter…

Date

Dates for the search.

Accession #

Accession #. Searching for the accession number requires an exact match.

Requested Procedure ID

Requested procedure ID. Searching for the requested procedure ID requires an exact match.

Scope

Select US Only to search for procedures scheduled on all ultrasound systems; select This system only to confine the search to procedures scheduled on this ultrasound system.

Offline

Select the Use Cache check box to save results of the most recent Worklist search on the ultrasound system. When Use Cache is selected, fields and buttons within the Search Criterion section at the bottom of the Worklist Search screen are not available. You are unable to enter search criteria or perform a search if Use Cache is selected. Select the Reset Cache button to clear any existing Worklist search results already stored on the ultrasound system. The system then downloads the current Worklist search results onto the ultrasound system. When you select the Reset Cache button, the system selects the Use Cache checkbox automatically. You can then move the system to another location; the results of the search are available on the ultrasound system even when it is not connected to the network. Note: Before performing another search, reconnect the system to the network and ensure that Use Cache is not selected.

5 - 14

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Fields Displayed on the Choose Procedure Screen (Requires software version 2.0 or higher) The Choose procedure screen displays the selections in the Worklist Search screen.Only the Scheduled Procedures drop-down list is available. Selection

Description

Scheduled Procedures

Lists available procedures for the selected study. Procedures are identified by modality, study code, and description.For modality, US is ultrasound.

Editing Patient Data You can edit entries on the Patient Data form at any time during the patient examination. To display the Patient Data form: 1. Press the F3 function key on the keyboard. The system displays the Patient Data form. 2. Use the keyboard to update your entries. Changes to the Patient Data form are also updated on the image screen and in the report for exams with a patient report. Changes to fields used in calculations cause the system to update previously measured results. 3. Roll the trackball to the OK button and then press the SET key to save the revisions to the patient information and redisplay the image screen. To restore the current Patient Data form and redisplay the image screen without saving the revisions, roll the trackball to the Cancel button and then press the SET key.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 15

5 Beginning an Examination

Changing the Exam Type You can change the exam type at any time by making a selection from the Exam and QuickSet List. System-defined exam types and user-defined QuickSets display on this list. A QuickSet is an optimized configuration of imaging parameter settings for a specific transducer, exam, and operating mode. Use the system presets to select an exam or QuickSet to automatically activate when you power on the system.

[2] Instructions for Use Creating QuickSets

Ch A1

F6 Boot Up ►Boot Up Exam & QuickSet

Accessing the Exam and QuickSet List Use one of these methods to access the Exam and QuickSet List: Press the F5 key on the keyboard. Roll the trackball to the EXAM button on the New Patient Data or Patient Data form and then press the SET key. To select or change the exam type or QuickSet: 1. Access the Exam and QuickSet List by pressing the F5 key on the keyboard. The system displays a list of system-defined exam types and a list of QuickSets. Note: If the transducer associated with a QuickSet is not connected to the system, the QuickSet is not selectable.

2. Roll the trackball to highlight the name of the required exam type or the QuickSet and then press the SET key. The system displays the name of the selected exam type or QuickSet in the upper left of the image screen. 3. To redisplay the image screen without selecting an exam type or QuickSet, select the Cancel button.

5 - 16

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Exam Type Abbreviations The system displays an abbreviation that indicates the active exam type in the upper left of the image screen. The system-defined exams are abbreviated as follows: Abd

Abdominal

OB

Obstetrics

Early OB

Early Obstetrics

Breast

Breast

Thyroid

Thyroid

Testicle

Testicle

GYN

Gynecology

Ortho

Orthopedics

Cardiac

Cardiac

Urology

Urology

Cranial

Cranial

1

Rectal 1

EM

1

Rectal Emergency Medicine

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 17

5 Beginning an Examination

Activating a Transducer Although multiple transducers can be connected to the ultrasound system, only one transducer can be active. Use the system presets to select the transducer port that will be active at system power-on.

System Reference System Presets

Ch 3

F6 Boot Up ► Transducer Port Active On Boot Up

To activate a transducer connected to the system: 1. Press the TRANSDUCER key located on the control panel. The name of the active transducer displays on the upper left of the screen. 2. To activate another transducer connected to the system, press the TRANSDUCER key again.

5 - 18

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Selecting an Operating Mode When powered on, the system automatically displays in 2D-mode. You can change modes by pressing the appropriate control or key located on the control panel. You can select A-mode and full-screen M-mode sweeps using the 2D-mode menu. Use the system presets to display the 2D image simultaneously with the M-mode sweep when M-mode is selected. If you do not activate the bypass cursor display selection in the system presets, the system displays the 2D image with the cursor when M-mode is selected and you must select the control a second time to display the sweep.

F6 Default Settings ► Bypass M Cursor Display

Mode

Selection

A-mode

Press the 2D control on the control panel, press the MENU control on the control panel, and then select A-mode.

2D-mode

Press the 2D control on the control panel.

Split (B+B) mode

Press the SPLIT key on the control panel.

Dual-mode

Press the left or right DUAL/SELECT key on the control panel. A 2D image displays in the respective half of the image area. Press the other DUAL/SELECT key to display an image in the other half of the display area. The last DUAL/SELECT key pressed (left or right) establishes the active image. Press either key twice to display the image full-screen. Return to dual displays by pressing the key once again.

4B-mode

Press the 4B key on the control panel.

2D/M-mode

Press the M control on the control panel two times while in 2D-mode.

Split 2D/M-mode

Press the SPLIT key on the control panel and then press the M control.

M-mode

Press the M control on the control panel two times while in 2D-mode, press the MENU control on the control panel, and then select Full M.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 19

5 Beginning an Examination

Examination Completion Printing a Patient Report For exam types with a patient report, the system transfers labeled measurements and calculations from a Measurement Menu on the image screen to a report. You can print the report to an optionally installed video printer using the control panel, or you can transfer the report to the USB or RS-232C port by selecting the Send Report button on the report page.

System Reference System Presets Printer Installation

Ch 3 Ch 5

Video Printer (On-board) Use the system presets to assign a documentation control to the printing function. To print the report to an on-board video printer: Press the documentation control (PRINT STORE, DIGITAL STORE 1, or DIGITAL STORE 2) on the control panel configured for the print function.

F6 System Configuration ►Peripheral ►►RS-232 ►►USB ►Customize Keys ►Storage

The system transfers the information displayed on-screen to the specified documentation device.

Peripheral Printer (Off-board) Use the system presets to assign functionality to the serial port or to a USB port as the destination for data sent through the system. To send data to a USB port or the RS-232C port: Roll the trackball to the Send Report button on the report and then press the SET key on the control panel. The Send Report button is changed to the Cancel button. To cancel the Send Report command: To interrupt immediately, roll the trackball to the Cancel button and then press the SET key. To stop after the current page, press the ESCAPE key.

5 - 20

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 Beginning an Examination

Ending an Exam You can complete the patient examination from the DIMAQ-IP Image screen or Study screen. To access the DIMAQ-IP screens (Study screen and Image screen): 1. Press the REVIEW key on the control panel. If a patient is currently registered, then the system displays the Image screen. If there is not a patient currently registered, then the system displays the Study screen. 2. To display the Image screen (from the Study screen), select the Image Screen button on the left of the screen. 3. To display the Study screen (from the Image screen), select the Study Screen button on the left of the screen. To complete the patient examination, choose one of the following: Select the Close Study button on the left of the Image screen. Select the Close or New button in the Study box on the right of the Study screen. Press the F1 key on the keyboard to begin a new examination and select the OK button to register the new patient. Shut down the ultrasound system. You can change the Patient Name and/or ID without closing the current patient examination. Note: If you select a previous study from the Study screen list when a study is current and has not been completed, the current study is not closed.You can select the current study again from the Study screen.

A current study is identifiable in the Study screen when the following two conditions are met: It has the most recent Date/Time stamp in the Study screen list. The Close button in the Study screen is available when this study is selected.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

5 - 21

5 Beginning an Examination

5 - 22

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description Standard Features .............................................................................................. 3 Operator Control Panel .................................................................................. 3 Multi-Lingual System Operating Software..................................................... 3 Processing Power.......................................................................................... 3 High Resolution Monochrome Monitor ......................................................... 4 Mobility.......................................................................................................... 4 Transducer Compatibility ............................................................................... 4 User-Accessible Connections ........................................................................ 4 Operating Modes .......................................................................................... 5 Single Modes ......................................................................................... 5 Mixed Modes ......................................................................................... 5 Imaging Functions ......................................................................................... 6 Options................................................................................................................ 7 Measurements, Calculations, and Reports ...................................................... 8 General Functions.......................................................................................... 8 General 2D-Mode Measurements and Calculations ............................... 8 General M-Mode Measurements and Calculations ................................ 8 Exam-Specific Measurements and Calculations ............................................ 9 Abdominal .............................................................................................. 9 Breast..................................................................................................... 9 Thyroid ................................................................................................... 9 Testicle................................................................................................... 9 Gynecology ............................................................................................ 9 Urology................................................................................................... 9 Rectal ..................................................................................................... 9 Obstetrics............................................................................................. 10 Orthopedic ........................................................................................... 11 Cranial .................................................................................................. 11 Cardiac ................................................................................................. 11 Measurement Accuracy .............................................................................. 12 Image Display ................................................................................................... 13

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 1

6 Technical Description

System Requirements...................................................................................... 14 Power Supply Requirements....................................................................... 14 Possible Combinations with Other Equipment ............................................ 14 Leakage Currents ................................................................................. 14 Audio, Video, and Data Transmission Connections Input and Output Signals...................................................................................... 15 Environmental Requirements ...................................................................... 16 Protective Measures ............................................................................ 16 Maximum Physical Dimensions ........................................................... 16 System Classifications ..................................................................................... 17 Standards Compliance..................................................................................... 18

6 - 2

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Standard Features Operator Control Panel Trackball Backlit controls and keys Task lighting for control panel Language-specific control panel overlays Alphanumeric keyboard with special function keys

Multi-Lingual System Operating Software Windows-based operating software Multi-language capability, selectable during software installation User-modifiable system presets, including libraries of annotations and pictograms QuickSet feature for defining up to 32 sets of specific exam, transducer, and image parameter settings

Processing Power DIMAQ-IP integrated workstation SynAps™ synthetic aperture technology for improved image quality at depth Pathway for future performance expansion and technological innovations

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 3

6 Technical Description

High Resolution Monochrome Monitor 30 cm (12-inch) High resolution, (non-interlaced) with 640 x 480 pixel display matrix Tilt of 15° up and 15° down Swivel of 270° Brightness, contrast, and degauss controls Energy savings compliant per VESA Display Power Management Signaling standard

Mobility Mobile console with swivel wheels and brakes for transport Front steering handle for ease in mobility

Transducer Compatibility 2.0 to 10.0 MHz imaging range capability Wideband MultiHertz™ multiple frequency imaging 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

Detachable transducer and gel holders Transducer cable management microCase™ transducer miniaturization technology for increased user comfort and reduced fatigue Lightweight, ergonomic transducer design with SuppleFlex™ cables

User-Accessible Connections Compact disk CD-RW drive for use with the DIMAQ-IP integrated ultrasound workstation On-board location for one recording device (analog output) RS-232C port for data transfer to an off-board printer or personal computer (PC) USB port for off-board printer connectivity (2 ports) and for installation of software-based system options using a "key disk" (memory stick) Ethernet port User-programmable, dual-pedal footswitch (optional)

1

Requires software version 2.0 or higher

6 - 4

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Operating Modes The following modes are available on the system:

Single Modes 2D-mode, Dual mode, 4B-mode, and Split (B+B) mode in fundamental and harmonics M-mode A-mode

Mixed Modes 2D/M-mode

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 5

6 Technical Description

Imaging Functions 2D-mode and M-mode imaging with mixed modes for 2D/M and A-mode display 256 gray shade display with selectable gray maps (seven maps) Up to 22 choices for magnification in frozen or real-time imaging 20 mm to 240 mm depth of view display in 10 mm increments (transducer dependent) User-adjustable single, dual, and quadruple focusing CINE: Up to 255 gray scale frames Zoom ReadySet™ on-screen workflow shortcuts for immediate access to the most frequently-used functions (user-programmable) QuickSet™ user-programmable system parameters for streamlining exam and workflow steps

6 - 6

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Options THI™ Tissue Harmonic Imaging Technology –

Enhances visualization, particularly in difficult-to-image patients

–

Improves image contrast and spatial resolution; reduces noise

–

Ensemble Tissue Harmonic Imaging (THI) is available with the following transducers and THI frequencies: C4-21: 5.0T, 5.6T C5-2: 5.0T, 5.6T L10-5: 10.0T

TGO™ Tissue Grayscale Optimization Option –

Provides "one-button" image optimization, by immediately adjusting imaging parameters to the tissue type being imaged

–

For use with every exam type and imaging frequency, including THI (when installed)

–

Available on all transducers

DICOM 3.0 Connectivity Option –

Software license for use of networking software

–

Provides digital image transfer using a DICOM network for both printing and storage. When the option is installed, the ultrasound system is a "DICOM Print Class User" (for printing to a networked DICOM printer) and a "DICOM Storage Class User" (for storage to a networked DICOM workstation and/or archive device).

DICOM Modality Worklist Option (requires the DICOM Connectivity Option) –

Software license for querying and directing the download of a patient work schedule from a HIS/RIS system (Hospital Information System/Radiology Information System) to the ultrasound system

–

Automatically populates the patient registration form with patient demographic information

DICOM MPPS Option1 (requires the DICOM Connectivity Option and DICOM Modality Worklist Option) Dual footswitch Monitor filter (for bright lighting conditions) Clip Store1 Brachytherapy Software option1 (requires systems configured with a mechanical sector transducer port and the use of the Endo-P II transducer)

1

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 7

6 Technical Description

Measurements, Calculations, and Reports Two categories of measurements and calculations are available on the ultrasound system: general and exam-specific.

General Functions 2D-mode and M-mode imaging have up to eight (8) distance sets of caliper measurements per image Area and circumference: up to eight Ellipse and Trace measurements per image Ratio Calculations

General 2D-Mode Measurements and Calculations Angle Distance/Depth Circumference (using a Trace or Ellipse method) Area (using a Trace or Ellipse method) Volume (using a 2-Plane Volume or a 1-Plane Volume) Residual Volume and Thyroid Volume

General M-Mode Measurements and Calculations Distance Time Heart Rate Slope Ratio Calculations

6 - 8

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Exam-Specific Measurements and Calculations The measurement function is arranged by exam type and is available for use with all exam types.

Abdominal All general measurements and calculations

Breast All general measurements and calculations

Thyroid All general measurements and calculations Thyroid volume

Testicle All general measurements and calculations

Gynecology All general measurements and calculations Right and left follicle, uterus, and right and left ovary measurements Gynecology patient report

Urology All general measurements and calculations Micturated volume Prostate dimensions Prostate and urology patient report

Rectal1 All general measurements and calculations Stepwise volume Incremental volume Rectal patient report

1

Requires software version 2.0 or higher

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 9

6 Technical Description

Obstetrics All general measurements and calculations

[2] Instructions for Use

Early OB and Standard OB parameter labels

Obstetrics

Ch B2

Early OB and Standard OB measurement labels Menstrual Age paramter labels Up to five user-defined Menstrual Age formulas or tables Up to five user-defined ratios of parameters Up to five user-defined Growth Analysis formulas or tables Up to five user-defined measurement labels are available in 2D-mode Calculations for parameters and estimated fetal weight (EFW) Calculations for both clinical and ultrasound menstrual age, and estimated date of confinement Two system-defined formulas for estimating fetal body weight: EFW1 and EFW2 Up to five user-defined formulas for estimating fetal body weight Two formulas for composite ultrasound menstrual age calculation: Direct/Average, system-defined Early Obstetric patient report and Standard Obstetric patient report include a worksheet for viewing the progress of the report during the exam process and to edit the report, along with multiple fetus reporting capabilities Growth Analysis Graphs

6 - 10

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Orthopedic All general measurements and calculations Right and Left Hip Angle measurement Orthopedic report

Cranial All general measurements and calculations

Cardiac 2D-mode Trace, Distance, and Angle measurements Volume formulas for Left Ventricular function assessment (eight formulas) 2D-mode and M-mode calculations M-mode Slope, Heart Rate, Time, and Distance measurements Cardiac worksheet and patient report

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 11

6 Technical Description

Measurement Accuracy The following table describes the variability in accuracy for each parameter: Parameter

Ranges

Accuracy

Image Depth Scale

20 to 240 mm

< ± 3% of full scale

Image Time Scales

2, 4, 8, 16 sec.

< ± 5 ms

Two-dimensional Measurements – Distance/Depth

up to 240 mm

< ± 3% or < 1 mm, if below 33 mm

– Area

up to 999 cm2

< ± 6% or < 66 mm2, if below 11 cm2

– Trace (Ellipse)

up to 999 cm2

< ± 6% or < 66 mm2, if below 11 cm2

– Angle

0° to 180°

< ± 3% on ½ segment

Result B/A & (A-B)/A

up to 1.0

< ± 10% of A

Result A/B

1.0 to 99.9

< ± 10% of A

– Depth

up to 240 mm

< ± 3% or < 0.5 mm, if below 17 mm

– Time

up to 16 sec.

< ± 2%

– Heart Rate

15 to 999 bpm

< ± 5%

– Volume (Area, Length, Diameter)

up to 999 cm3

< ± 9% or < 3.2 cm3, if below 36 cm3

– Thyroid Volume

up to 999 cm3

< ± 9% or < 3.2 cm3, if below 36 cm3

– Urine Remainder

up to 999 ml

< ± 9% or < 3.2 cm3, if below 36 cm3

– Ratio (A/B)

Time Motion (TM) Measurements

Volume Measurements

6 - 12

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Image Display Video Standards:

VGA

Monitor:

Monochrome, 30 cm (12-inch), high resolution, (non-interlaced) monitor with 640 x 480 pixel display matrix

Gray Scale:

256 levels

Image polarity:

Positive (black on white) or negative (white on black)

Date/Time display:

System displays current date and time above the imaging area. Clock freezes in frozen image. Daylight saving time changes available in system presets.

Image field size: (by frequency)

3.5 MHz = 20 to 240 mm 5.0 MHz = 20 to 240 mm 7.5 MHz = 20 to 140 mm 10.0 MHz = 20 to 240 mm 12.0 MHz = 20 to 240 mm The depth is selectable in increments of 10 mm. Minimum and maximum depth values for each frequency are transducer dependent.

Image Orientation:

Left-to-right or right-to-left orientation for 2D, Split (B+B), Dual, and 4B modes; 2D image in mixed 2D/M-mode. Active image indicator designates direction of scan. 90-degree rotation for 2D, Split (B+B), Dual, and 4B modes; 2D image in 2D/M-mode.

Image Position:

Image can be offset vertically and horizontally 2D steering for linear array transducers

Other Imaging Parameters:

Transmit power displayed in decibels (dB) or percentage (%) Overall System Receiver Gain combined with DGC Gain totals 70 dB Depth Gain Compensation (DGC) – Eight DGC slide controls for DGC Gain Pre-processing – Edge Enhancement in six steps; Image Persistence in eight steps; Dynamic Range 35 to 70 dB in 1-dB steps. Post-processing – Seven variable gray scale compression maps. Focusing – 1, 2, and 4 transmit focal zones for all electronic array transducers; number and position of focal zones are user-selectable

Image Screen Display:

Millimeter (mm) scale marker with depth of display, focal zones: number and position, gray bar, trackball arbitration, active image indicator, error and help messages. Values for the following image parameters: 2D/M Gain, Dynamic Range, Edge Enhancement, and Gain. Active transducer and transmit frequency, exam type, active measurement method, Measurement Menu, Measured Results. Onscreen menu selections for mode-specific imaging and onscreen menu selections for a feature. ReadySet™ on-screen workflow shortcuts.

Patient Data Form:

Fields for identification of the patient and physician.

Text Annotation:

Customize phrase libraries for patient reports and onscreen annotation. You can directly enter text on the image screen using the keyboard.

Pictograms:

Standard and exam-specific graphics representing anatomical structures are user selectable. Transducer position and orientation are also available for positioning on the pictograms.

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 13

6 Technical Description

System Requirements This section describes the power and environmental requirements for the ultrasound imaging system.

Power Supply Requirements MAINS Voltage

Range

Maximum Current

Frequency

230V ~

196V~ to 264V~

1.6 amps

50/60 Hz

115V ~

98V~ to 132V~

3.0 amps

50/60 Hz

100V ~

90V~ to 110V~

3.5 amps

50/60 Hz

Possible Combinations with Other Equipment Only the peripheral devices listed in the System Reference are approved for use with the ultrasound system. Any use of other devices with the system will be at the user's risk and may void the system warranty.

System Reference Accessories and Options

Ch 2

On-board peripheral devices must be installed by an authorized Siemens representative or approved third party. WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards (e.g., 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 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 Accessories and Options chapter. If in doubt, consult Siemens service department or your local Siemens representative.

Leakage Currents WARNING: Connecting peripheral products and accessories from non-isolated sources may result in chassis leakage current exceeding safe levels.

6 - 14

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 Technical Description

Audio, Video, and Data Transmission Connections Input and Output Signals Input/Output

Connector

Composite Video

BNC-type (1 input, 2 output)

Y/C Video

S-terminal (1 input, 1 output)

USB

Series A type (2)

Ethernet

RJ45 (1)

Output

Connector

VGA

D-sub, 15-pin, female (1)

RS-232-C port for printer/VCR/PC communication

D-sub, 9-pin, female (1)

Remote printer connector

Mini-jack (stereo) (1)

B/W Video

BNC-type

[ 1 ]

I N S T R U C T I O N S

F O R

U S E

6 - 15

6 Technical Description

Environmental Requirements 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.

Ambient (During Storage or Transportation)

During Operation Maximum Altitude:

Operation up to 3,000 meters (1060 hPa)

Relative humidity:

20% to 80%, non-condensing

50%) Moderate(EF 30-50%) Poor(EF < 30%)

EF

[ 2 ]

Ejection Fraction

I N S T R U C T I O N S

F O R

U S E

Calculation results based on EDV and ESV measurements

B3 - 13

B3 Emergency Medicine Measurements and Calculations

Bladder Description of Unique Report Fields Note: If a measurement has been completed, the system inserts an asterisk mark (*).

Field

Description

Selections

Imaged transversely

Check box to indicate the orientation of image.

---

Depth

Measured results

---

Width

Measured results

---

Imaged sagitally

Check box to indicate the orientation of image.

---

Depth

Measured results

---

Length

Measured results

---

Volume

Calculated results based on transverse and/or sagittal plane measurements and the labeled measurements used to calculate the volume.

Trans D (Transverse Depth) Trans W (Transverse Width) Sag D (Sagittal Depth) Sag L (Sagittal Length)

DVT (Deep Vein Thrombosis) Description of Unique Report Fields Field

Description

Selections

Leg imaged

Leg Imaged

Right Left

CFV

Common Femoral Vein

Compressible Non-compressible Not imaged

SFV

Superficial Femoral Veins

Compressible Non-compressible Not imaged

Pop. V

Popliteal Vein

Compressible Non-compressible Not visualized

B3 - 14

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B3 Emergency Medicine Measurements and Calculations

Viewing and Using the Report Accessing the Report and Report Sections (Tabs) To access the Report: 1. During an EM exam, press the F2 key on the keyboard or roll the trackball to highlight Report in the Measurement Menu and then press the SET key. The system displays the first tab of the Report. 2. To access a different report tab, roll the trackball to position the pointer on the name of the tab and then press the SET key. 3. To redisplay the image screen, press the ESCAPE key or roll the trackball to position the pointer on Return at the bottom of the report and then press the SET key.

Selecting a Check box To select a check box: 1. Access the patient report. 2. Roll the trackball to position the pointer on a check box and then press the SET key.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B3 - 15

B3 Emergency Medicine Measurements and Calculations

Inserting Comments To add comments to a report: 1. Access the patient report. 2. Roll the trackball to position the pointer in the Comments field and then press the SET key. Note: When adding new comments to existing comments, roll the trackball to position the pointer at the end of the existing text in the Comments field and then press the SET key.

F6 M&R ►Measurement and Report Preset ►►Comments Library for Report

3. Use the keyboard to add new comments or edit the existing comments. Note: Enter your comments as a single paragraph. Do not use the Enter key on the keyboard to separate lines of comments.

To create comments for the patient report using the system presets: 1. Access the Comments Library for Report screen. 2. Roll the trackball to position the pointer in one of the five text boxes and then press the SET key. 3. Type the comment text and then press the SET key. Note: Enter your comments as a single paragraph. Do not use the Enter key on the keyboard to separate lines of comments.

4. Repeat steps 2 and 3 as required to create comments for the report. You can also edit or add to existing comments. 5. When you are finished, roll the trackball to position the pointer on OK and then press the SET key.

B3 - 16

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B3 Emergency Medicine Measurements and Calculations

To add comments from the system presets to a report: 1. Roll the trackball to position the pointer on Comments, and then press the SET key. The system displays the list of comments from the presets in the Comments Dialog. 2. Roll the trackball to highlight the comment and then press the SET key. 3. Roll the trackball to position the pointer on OK and then press the SET key. The system places the selected text in the Comments field. 4. Repeat steps 2 and 3 as required to annotate the report.

System Reference Documentation Devices

Ch 4

Note: When adding new comments to existing comments, roll the trackball to position the pointer at the end of the existing text in the Comments field and then press the SET key.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B3 - 17

B3 Emergency Medicine Measurements and Calculations

Printing the Report To print the patient report: Use the system presets to specify a destination device and format for the Report. 1. Roll the trackball to position the pointer on Send Report at the bottom of the report screen and then press the SET key. The system transfers the patient report to the destination device.

F6 System Configuration ►Peripheral ►Customize Keys ►Storage

2. If the system is configured for more than one destination device, then select the output destination in the dialog box, and press the SET key.

B3 - 18

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations Urology and Rectal Measurements and Calculations ..................................... 3 Measurement Menu...................................................................................... 3 Urology 2D-Mode Measurement Labels..................................................... 4 Urology 2D-Mode Calculation Label............................................................ 4 Rectal 2D-Mode Measurement Labels ....................................................... 5 Stepwise Volume ................................................................................... 6 Incremental Volume ............................................................................... 8 Urology and Rectal Patient Reports............................................................. 10 Annotating a Report ............................................................................. 11 Urology Report Descriptive Data ....................................................... 12 Rectal Report Descriptive Data.......................................................... 14 Report Drawing Function............................................................................. 15 References ........................................................................................... 16

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 1

B4 Urology and Rectal Measurements and Calculations

B4 - 2

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

Urology and Rectal Measurements and Calculations All general measurements and calculations in 2D-mode and M-mode are available for use with the Urology or Rectal1 exam. Each exam has specific 2D-mode labels and a patient report.

Measurement Menu

[2] Instructions for Use General Measurements Measurement Menu

Ch B1 Ch B1

During a Urology or Rectal exam, activating the measurement function causes the system to display a Measurement Menu on the left side of the image screen. The Measurement Menu contains system-defined measurement and calculation labels.

1

Requires software version 2.0 or higher

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 3

B4 Urology and Rectal Measurements and Calculations

Urology

2D-Mode Measurement Labels

The system-defined measurement labels display in the Measured Results when the Urology exam is selected and in the Urology patient report with the measured result, when assigned. Measurement Label

Description

Measurement Method Options

U.Blad

Urinary bladder

n/a

Pre V

Pre-void Volume

2Pl LxDxW Volume

Post V

Post-void Volume

2Pl LxDxW Volume

(Mic V)

Micturated Volume

(calculated)

Prostate Volume

2Pl LxDxW Volume

Prostate-V1 Volume Length

Distance

Depth

Distance

Width

Distance

Prostate-V2

Prostate Volume

2Pl LxDxW Volume

Volume Length

Distance

Depth

Distance

Width

Distance

Urology

2D-Mode Calculation Label

The 2D-mode calculation label for use with the Urology exam, PSAD, does not display in the Measurement Menu. Instead, the system automatically performs a calculation if you enter a PSA value in the Urology patient report and complete a volume measurement of the prostate. Calculation Label

Description

Required Measurements

PSAD

Prostate Specific Antigen Density — Index determined by the PSA value divided by the prostate volume calculation.

A Volume (V) measurement of the Prostate and the PSA value entered using the keyboard in the Urology patient report.

B4 - 4

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

Rectal

2D-Mode Measurement Labels

The system-defined measurement labels display in the Measured Results when the Rectal exam is selected and in the Rectal patient report with the measured result, when assigned. Measurement Label

Description

Measurement Method Options

Endrec-V1

Endorectal Volume

2Pl LxDxW Volume

Volume Width

Distance

Depth

Distance

Length

Distance

Endrec-V2

Endorectal Volume

2Pl LxDxW Volume

Volume

[ 2 ]

Width

Distance

Depth

Distance

Length

Distance

I N S T R U C T I O N S

F O R

U S E

B4 - 5

B4 Urology and Rectal Measurements and Calculations

Stepwise Volume (Requires software version 2.0 or higher) System Reference

Note: Use the system presets to add the Step Vol measurement to the 2D-mode Measurement menu for the Rectal or Urology exam type.

System Presets

Stepwise Volume is a real-time measurement and is available only when the Endo-P II transducer is selected. The diameter for the structure of interest is measured in the transverse plane using a Distance measurement method, and the value obtained is displayed as a length. A Trace measurement is then performed on each section of the structure of interest, in the longitudinal plane, and the system accumulates the calculated areas to determine the volume for the structure.

Ch 3

F6 M&R X Measurement and Report Preset XX Customize General Measurement Menu

To measure Stepwise Volume: 1. Activate the Measurement function without freezing the image.

[2] Instructions for Use

2. Roll the trackball into the Measurement menu to highlight Step Vol and then press the SET key on the control panel.

Endo-P II Transducer Ch C3 Biopsy (Puncture) Function Ch A4

The system displays a dialog box listing available settings for the number of sections. 3. To change the number of sections to be traced, use the trackball and SET key to select the up or down arrow to the right of the displayed setting until the required setting is displayed. Note: Available selections are 3 to 9, in increments of 1.

4. To save the number of sections and exit the dialog box, use the trackball and SET key to select the OK button on the dialog box. The system displays the first measurement marker in the image. 5. Roll the trackball to position the first measurement marker in the transverse plane and then press the SET key. The system displays the second measurement marker on the image.

B4 - 6

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

6. Roll the trackball to position the second measurement marker to define the length and then press the SET key. The transducer changes to the longitudinal plane. 7. Roll the trackball to position the first measurement marker for the trace and then press the SET key. The system anchors the first marker and displays a second measurement marker over the first marker. 8. Roll the trackball to outline the structure of interest and then press the the SET key to close the trace.. The system displays the area (A) and circumference (C) values for that section in Measured Results, and then displays a measurement marker in the next section. 9. Repeat steps 7 and 8 for each section. The system displays the area (A) and circumference (C) values for each section as the trace is completed. When all sections are measured, the system displays the calculated volume for the structure of interest in Measured Results. 10. To transfer the measured result to the patient report, you must assign the result to a Volume label. a.

Roll the trackball to highlight the menu category at the top of the Measurement Menu and then press the SET key. The system displays the list of menu categories, such as Rectal (2D), Urology (2D) and Other.

b. Roll the trackball to select Rectal (2D) or Urology (2D) and then press the SET key. c.

Roll the trackball to select the Volume label and then press the SET key. The system transfers the measured volume to the patient report.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 7

B4 Urology and Rectal Measurements and Calculations

Incremental Volume (Requires software version 2.0 or higher) System Reference

Note: Use the system presets to add the Incr Vol measurement to the 2D-mode Measurement menu for the Rectal exam type.

System Presets

Ch 3

The Incremental Volume measurement is specifically for use with the Endo-P II transducer during a Rectal exam type in combination with a separately purchased stepper device. The system calculates a volume of the prostate based on a series of sequential area measurements. Area measurements are obtained by tracing several outlines of the prostate in progressive planes. The outlines are traced in increments. These increments are determined by the stepsize. ∑ 1/3 ( PA(i) + PA(I-1) + √ (PA(i) x PA(i-1)) ) x Stepsize Use the system presets to modify the stepsize.

F6 M&R X Measurement and Report Preset XX Customize General Measurement Menu M&R XUrology Stepsize

To measure Incremental Volume: Note: This measurement method is specifically for use with the Endo-P II transducer in the transverse plane. The transducer is used with a stepper device. Activate the Biopsy function and ensure the Tpl guidelines are displayed before beginning this procedure. To display the Tpl guidelines, select the Tpl option from Type on the Biopsy menu. Note: If ESCAPE is pressed at any time during this process, the measurement will end.

[2] Instructions for Use Endo-P II Transducer Ch C3 Biopsy (Puncture) Function Ch A4

1. Activate the Measurement function. 2. Roll the trackball to highlight Incr Vol in the Measurement menu and then press the SET key on the control panel. The system displays the first measurement marker in the image and the stepsize indicated by Step in the Measured Results. 3. Roll the trackball to position the first measurement marker and then press the SET key. 4. Roll the trackball to outline the structure of interest and then press the the SET key to close the trace. The system displays values for the area, circumference, and the calculated volume in Measured Results. 5. Move (step) the transducer according to the stepsize in the Measurement menu.

B4 - 8

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

6. Press the FREEZE key on the control panel, acquire an image, then press the CALIPER key on the control panel for the next measurement. The system highlights Incr Vol in the Measurement menu to indicate that the measurement is being continued. 7. Repeat steps 3 through 6 until the last outline is complete. The system updates the cumulative total of all volumes. 8. To transfer the measured result to the patient report, you must assign the result to a Volume label. a.

Roll the trackball to highlight the menu category at the top of the Measurement Menu and then press the SET key. The system displays the list of menu categories, such as Rectal (2D), Urology (2D) and Other.

b. Roll the trackball to select Rectal (2D) and then press the SET key. c.

Roll the trackball to select the Volume label and then press the SET key. The system transfers the measured volume to the patient report.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 9

B4 Urology and Rectal Measurements and Calculations

Urology and Rectal Patient Reports The Urology exam and Rectal exam each have a patient report. The report includes data from the patient data form, measured values obtained during the exam that have been assigned to a label, and descriptive data and text entered by the user.

[2] Instructions for Use Drawing Function B4-15

You can use the Report Drawing function to indicate a specific structure of interest in the patient report. To access the Urology report: 1. During a Urology exam, press the F2 key on the keyboard or roll the trackball to highlight Report in the Measurement Menu and then press the SET key. The system displays the Urology patient report. 2. To redisplay the image screen, press the ESCAPE key or roll the trackball to Return at the bottom of the report and then press the SET key. To access the Rectal report: (Requires software version 2.0 or higher) 1. During a Rectal exam, press the F2 key on the keyboard or roll the trackball to highlight Report in the Measurement Menu and then press the SET key. The system displays the Rectal patient report. 2. To redisplay the image screen, press the ESCAPE key or roll the trackball to Return at the bottom of the report and then press the SET key. To use a drop-down box: Prerequisite: Access the report before beginning this procedure.

1. Roll the trackball to position the pointer in the drop-down box and then press the SET key. 2. Roll the trackball to highlight the selection and then press the SET key. To use a text entry field: Prerequisite: Access the report before beginning this procedure.

1. Roll the trackball to the text entry field and then press the SET key. 2. Use the keyboard to enter data.

B4 - 10

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

Annotating a Report There are two methods for entering text into the Comments section of a patient report. You can enter text from the keyboard or insert comments that you have pre-defined in the system presets. You can edit comments after placing them in the report. Note: If the report has more than one page, you must access the page containing the Comments field before the system will display the comments.

To enter text: 1. When a patient report is displayed, roll the trackball to place the text cursor at the required position in the Comments field of the report. 2. Enter text using the keyboard.

System Reference System Presets

Ch 3

F6 M&R XMeasurement and Report Preset XX Comments Library for Report\ Customize Keys

Note: Enter your comments as a single paragraph. Do not use the Enter key on the keyboard to separate lines of comments.

To insert pre-defined comments: Note: Use the system presets to pre-define comments for each exam type.

1. When a patient report is displayed, roll the trackball to the Comments button and then press the SET key. A list of available phrases displays on the screen. 2. Roll the trackball to highlight a phrase and then press the SET key. The system places the phrase in the Comments field of the report. Note: When adding new comments to existing comments, roll the trackball to position the pointer at the end of the existing text in the Comments field and then press the SET key.

3. Continue entering phrases. When finished, press the ESCAPE key on the control panel to exit. The system removes the list of phrases from the screen.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 11

B4 Urology and Rectal Measurements and Calculations

Urology Report

Descriptive Data

The Urology patient report contains drop-down boxes with descriptive data for the following information: Digital Rectal Exam (DRE) Malignancy Suspicion Trans Rectal Ultrasound System (TRUS) Prostate Trans Rectal Ultrasound System Seminal Vesicles Report Item

Selections

DRE Malignancy Suspicion

No Yes Right Left No/-Base Yes/-Base Right/-Base Left/-Base No/-Apex Yes/-Apex Right/-Apex Left/-Apex No/-Mid Yes/-Mid Right/-Mid Left/-Mid

TRUS Prostate Echogenicity

(Blank) Normal Hyperechoic Isoechoic Hypoechoic Diffuse

TRUS Prostate Margin

(Blank) Intact Disrupted Intact/-Right Disrupted/-Right Intact/-Left Disrupted/-Left Intact/-Apex Disrupted/-Apex Intact/-Mid Disrupted/-Mid Intact/-Base Disrupted/-Base

B4 - 12

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

Report Item

Selections

TRUS Prostate Size

(Blank) Normal Enlarged Atrophic Hypertrophic

TRUS Prostate Symmetry

(Blank) Yes No L>R R>L

TRUS Seminal Vesicle Symmetry

(Blank) Yes No L>R R>L

TRUS Seminal Vesicle Size

(Blank) Normal Enlarged Atrophic Hypertrophic

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 13

B4 Urology and Rectal Measurements and Calculations

Rectal Report

Descriptive Data

(Requires software version 2.0 or higher) The Rectal patient report contains drop-down boxes with descriptive data. Report Item

Selections

Lymph Node

None Seen Yes Multiple

Echogenicity

(Blank) Hyperechoic Isoechoic Hypoechoic Diffuse

[Rectal] Wall

(Blank) Intact Disrupted Not Seen

Tumor

None Seen Yes Multiple

Echogenicity

(Blank) Hyperechoic Isoechoic Hypoechoic Diffuse

B4 - 14

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 Urology and Rectal Measurements and Calculations

Report Drawing Function Use the Report Drawing function to indicate structures of interest on the pictograms in the Urology patient report or the Rectal patient report. To indicate a structure of interest in the displayed report: 1. Roll the trackball to the Draw button on the report and then press the SET key on the control panel. A square cursor displays in the middle of the pictogram on the report. 2. Roll the trackball to place the cursor where you want to begin tracing and then press the SET key. 3. Roll the trackball to create a trace. Undo the trace prior to completion by pressing the SELECT control on the control panel. Each press of this control deletes the next most recent dot. Resume tracing by rolling the trackball at any time. If necessary, press the ESCAPE key on the control panel to delete the entire trace prior to completion. 4. When you have completed the drawing, press the SET key. The system joins beginning and ending cursor positions and marks the area created by the trace. 5. Repeat steps 1 through 4 for each structure of interest. To remove a trace drawing from the displayed report: 1. Roll the trackball to the Delete button and then press the SET key. The system displays a marker in the middle of the pictogram. 2. Roll the trackball to position the marker on the trace drawing and then press the SET key. The system deletes the trace drawing. 3. Repeat steps 1 and 2 as required for each trace drawing.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B4 - 15

B4 Urology and Rectal Measurements and Calculations

References Prostate Volume Rifkin, Matthew D., M.D. "Prostate and Seminal Vesicle Measurements." Chapter 16 in Atlas of Ultrasound Measurements. B. B. Goldburg and A. B. Kurtz. Chicago: Year Book Medical Publishers, 1990. Littrup, Peter J., M.D., et al. "Determination of Prostate Volume with Transrectal US for Cancer Screening." Radiology 1991; 178:536-542, 179:49-53. Prostate Specific Antigen Density Benson, M. C., et al. "The Use of Prostate Specific Antigen Density to Enhance the Predictive Value of Intermediate Levels of Serum Prostate Specific Antigen." Journal of Urology, 147: 817, 1992.

B4 - 16

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations Cardiac Measurements and Calculations......................................................... 3 Customizing Cardiac Measurements and Reports......................................... 3 Activating the Measurement Function............................................................. 4 Image Screen Layout..................................................................................... 4 On-Screen Calipers................................................................................. 4 Averaging Measured Results ................................................................. 4 Cardiac Measurement Menu .......................................................................... 5 Guided Measurements.................................................................................. 6 Cardiac 2D-Mode Measurement Labels ..................................................... 7 Cardiac 2D-Mode Calculation Labels........................................................... 9 Cardiac 2D-Mode Measurements ............................................................. 10 Making a 2D-Mode Distance Measurement......................................... 10 Making a 2D-Mode Trace Measurement.............................................. 12 Cardiac 2D-Mode Left Ventricular Function Assessment ......................... 13 Determining a Left Ventricular End-Diastolic or End-Systolic Volume ................................................................................................. 15 2D-Mode Guided Measurements......................................................... 16 Cardiac M-Mode Measurement Labels..................................................... 20 Cardiac M-Mode Calculation Labels.......................................................... 21 Cardiac M-Mode Measurement Methods................................................. 23 Making an M-Mode Distance Measurement........................................ 23 Making a Heart Rate Measurement ..................................................... 24 Making a Time Measurement .............................................................. 25 Making a Slope Measurement ............................................................. 26 Cardiac M-Mode Left Ventricular Function Assessment........................... 27 Cardiology Patient Worksheets and Reports................................................. 31 Using the Cardiology Worksheet.......................................................... 31 Editing Worksheets .............................................................................. 33 Using the Cardiology Report ................................................................ 35

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 1

B5 Cardiac Measurements and Calculations

B5 - 2

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac Measurements and Calculations WARNING: Do not use the Cardiac Measurements and Calculations package unless you are thoroughly trained in echocardiography and thoroughly familiar with the safe operation of the ultrasound system.

Imaging the heart necessitates a unique methodology for precision measurements and calculation of equations. For this reason, the Cardiac exam provides measurements and methods for 2D-mode and M-mode that are selected from onscreen menus. Menu selections vary with the selected measurement type and mode. Calculated results display in the Measured Results section of the screen and, along with labeled measurements, are transferred to the Cardiac worksheet and patient report.

Customizing Cardiac Measurements and Reports Use the system presets to customize the Cardiac exam type. Options for Exam Configuration Default Settings Select the system response when the FREEZE key is pressed, display CINE or activate the measurement function.

System Reference System Presets

Ch 3

Create or edit the Pictogram List. Create or edit the Text Annotation List. Options for Measurements and Reports (M & R) Specify the shape, size, and default position for the caliper. Specify whether the background for the Measured Results section of the screen has a different color than the image background. Select the default measurement method for each mode. Select the default method for each type of measurement. Select the measurement methods that display for each mode, and the order in which they display. For left-ventricle guided measurements, select a system-defined pattern of measurement labels to include all the measurements for diastole and systole, or exclude specific labels from the guided measurement. For non-guided measurements, specify which labels display in the Measurement Menu and the order in which they display. Customize display options such as measurement titles for each mode, the method used for data averaging and operator and referring physician information for the patient report. Define the Comments Library for the patient report.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 3

B5 Cardiac Measurements and Calculations

Activating the Measurement Function After acquiring and freezing an image or sweep, activate the measurement function by pressing the CALIPER key. Use the system presets to activate the measurement function when the FREEZE key is pressed. You can also customize the system to highlight the Measurement Menu or display a measurement marker in the image when you activate the measurement function. The system displays a measurement marker on the image and a list of measurements in the Measurement Menu for assessing Cardiac function. Each imaging mode has a specific list of Cardiac measurement types and measurement labels.

Image Screen Layout The exam, transducer type, and Measurement Menu display on the left side of the image screen. Measured Results display at the bottom of the screen by default.

System Reference System Presets

Ch 3

F6 Default Settings ►Automatic Freeze Response M&R ►Caliper Default Position ►Default Menu Category

On-Screen Calipers Multiple caliper sets can display on an image or sweep at one time, depending on the measurement. Each marker is positioned by rolling the trackball and anchored in place by pressing the SET key.

Averaging Measured Results You can assign up to five values to each measurement label. The system transfers the values into the worksheet. Use the system presets to select a method for data averaging, Direct or Average. If you select the Direct method, the last value assigned to a measurement label displays next to the measurement units in the worksheet and in the patient report.

F6 M&R ►Measurement and Report Preset ►►Display Item

If you select the Average method, the system performs an average of the values as each value is assigned to the label. The last measured value displays in the Measured Results; the calculated average displays next to the measurement units in the worksheet and in the patient report.

B5 - 4

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac

Measurement Menu

The Cardiac exam has a Measurement Menu that displays on the left side of the image screen when the measurement function is active. The menu indicates which Cardiac measurement type is currently in use for the active imaging mode, and displays measurement labels for the measurement type. Use the system presets to customize the list of measurement labels for a non-guided measurement type, or to select a pattern of labels for a guided measurement type. To select a Cardiac measurement type: 1. Activate the measurement function. 2. Roll the trackball to highlight the menu category at the top of the Measurement Menu. 3. Press the SET key. The system displays the list of menu categories. For the Cardiac exam, the menu categories are Cardiac measurement types and general measurements (by mode). 4. Roll the trackball to select a Cardiac measurement type and then press the SET key. The system displays a list of corresponding measurement labels in the Measurement Menu.

System Reference System Presets

Ch 3

F6 M&R ►Measurement and Report Preset ►►Measurement Order

General (2D) Simpson SP Mod. Simpson Single Plane Example list of 2D-mode measurement types for Cardiac. Simpson SP EDV ESV Report Worksheet Example list of 2D-mode measurement labels for the selected measurement type.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 5

B5 Cardiac Measurements and Calculations

Guided Measurements Guided Measurements are system-defined sequences of individual measurements. A list of the necessary measurements for a guided measurement displays in the Measurement Menu. Once you have started a guided measurement sequence, you must perform the measurements in the specified order. The Cubed, Teichholz, and Gibson measurement types for 2D-mode and M-mode left ventricular function assessment use guided measurements for systole and diastole. For each measurement type, use the system presets to select a system-defined pattern of measurement labels to include all the measurements for diastole and systole, or exclude specific labels from the guided measurement.

B5 - 6

[ 2 ]

System Reference System Presets

Ch 3

F6 M&R ►Measurement and Report Preset ►►Measurement Order

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac

2D-Mode Measurement Labels

System-defined measurement labels for the active Cardiac measurement type display in the Measurement Menu. When a measured result is assigned to a label, the label and value display in the worksheet and the patient report. Use the system presets to customize the list of measurement labels for a non-guided measurement type, or to select a pattern of labels for a guided measurement type.

Measurement Menu Label

Description

Mitral Valve

Mitral Valve Function

System Presets

M&R ►Measurement and Report Preset ►►Measurement Order

Measurement Method

E Point to Septal Separation. The distance between the anterior leaflet and the ventricular septum at early diastole.

Distance

MVA(trace)

Mitral Valve Area

Trace

HR

Heart Rate

Aortic Valve/Left Atrium

AV Area

Aortic Valve Area

Trace

RV diam

Right Ventricular Diameter

Distance

AO

Aorta

Distance

ACS

Aortic Cusp Separation

Distance

LA diam

Left Atrial Diameter

Distance

Left Ventricular Dimensions

LV Dimensions RVAWd

Right Ventricular Anterior Wall at end-diastole

Distance

RVDd

Right Ventricular Dimension at end-diastole

Distance

IVSd

Interventricular Septal Dimension at end-diastole

Distance

LVIDd

Left Ventricular Internal Dimension at end-diastole

Distance

LVPWd

Left Ventricular Posterior Wall Dimension at end-diastole

Distance

IVSs

Interventricular Septal Dimension at end-systole

Distance

LVIDs

Left Ventricular Internal Dimension at end-systole

Distance

LVPWs

Left Ventricular Posterior Wall Dimension at end-systole

Distance

I N S T R U C T I O N S

Ch 3

F6

EPSS

AV/LA

[ 2 ]

System Reference

F O R

U S E

B5 - 7

B5 Cardiac Measurements and Calculations

Measurement Menu Label

Description

Volume-specific

Left Ventricular Volume

Measurement Method

LVAd sax PM

Left Ventricular Area at Papillary Muscle level at end-diastole in short axis view

Trace

LVAd sax MV

Left Ventricular Area at Mitral Valve level at end-diastole in short axis view

Trace

LVLd apical

Left Ventricular Length at end-diastole in apical view

Distance

LVAs sax PM

Left Ventricular Area at Papillary Muscle level at end-systole in short axis view

Trace

LVAs sax MV

Left Ventricular Area at Mitral Valve level at end-systole in short axis view

Trace

LVLs apical

Left Ventricular Length at end-systole in apical view

Distance

LVAd apical

Left Ventricular Long Axis Area at end-diastole in apical view

Trace

LVAs apical

Left Ventricular Long Axis Area at end-systole in apical view

Trace

B5 - 8

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac

2D-Mode Calculation Labels

The system performs 2D-mode calculations when you complete the required measurements and assigns calculation labels to the results. Calculated results display in the Measured Results section of the screen and are transferred to the Cardiac worksheet and patient report. Calculation Label

Description

Required Measurements

Units

CI

Cardiac Index is the cardiac output

L/min/m2

CI = CO÷BSA.

HR and BSA (BSA is determined by height and weight of patient; entered in the patient data form)

For height in centimeters and weight in kilograms:

EDV ESV

per square meter of body surface area (BSA):

BSA=0.007184 x (Weight0.425)x(Height0.725) For height in feet/inches and weight in pounds: BSA=0.007184 x (Weight x 0.454)0.425x(Height x 2.54)0.725

Cardiac Output is the effective volume of blood ejected from the left ventricle of the heart per unit of time:

CO

EDV ESV HR

L/min

Varies with the selected Volume method.

mL

EDV ESV

%

LVIDd LVIDs

%

SV BSA

mL/m2

EDV ESV

mL

CO = [(EDV – ESV) ÷ 1000](HR). EDV and ESV

Left Ventricular End-Diastolic Volume Left Ventricular End-Systolic Volume

Ejection Fraction is the ratio of the stroke volume to the end-diastolic volume:

EF

EF = 100[(EDV-ESV)÷EDV].

Fractional Shortening is the

FS

percentage of shortening of the Left Ventricular dimension. FS = 100[(LVIDd - LVIDs) ÷ LVIDd].

Stroke Index is a measurement of

SI

stroke volume normalized to BSA: SI = SV÷BSA.

Stroke Volume is the volume of

SV

blood ejected from a ventricle during one cardiac cycle or phase of ventricular systole: SV = EDV-ESV.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 9

B5 Cardiac Measurements and Calculations

Cardiac

2D-Mode Measurements

When the system is in 2D-mode with the Cardiac exam selected, activating the measurement function causes the system to display the list of cardiac measurement types or 2D-mode–specific measurement methods.

Making a 2D-Mode Distance Measurement The distance measurement calculates the length of a straight line between two markers. This procedure uses the CINE playback function so that both diastolic and systolic measurements can be made from one image acquisition. Use the system presets to customize the system to activate CINE playback when you activate the measurement function. To label then measure a distance: 1. During a Cardiac exam, acquire and freeze a 2D-mode image.

[2] Instructions for Use CINE

Ch A3

System Reference System Presets

Ch 3

F6

2. Press the CINE key to activate CINE playback. 3. Roll the trackball through Frame Review to view an end systolic or end diastolic frame.

Default Settings ►Automatic Freeze Response

4. Activate the measurement function. 5. If a list of measurement labels does not display, then select the menu category at the top of the Measurement Menu, and select the measurement type from the available categories (on the right) for the Measurement Menu. The Measurement Menu displays measurement labels. 6. Roll the trackball to select a measurement label in the Measurement Menu that requires the Distance method, and then press the SET key. The system displays the measurement method at the top of the Measurement Menu, activates the measurement method, and places a measurement marker on the image. The system also displays measurement data in the Measured Results. 7. Roll the trackball to position the measurement marker and then press the SET key. The system anchors a measurement marker and displays another measurement marker. 8. Roll the trackball to position the next measurement marker and then press the SET key. The system displays the measurement label and corresponding value in the Measured Results, and assigns the value to the label in the worksheet and the patient report.

B5 - 10

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

To measure then label distance: 1. During a Cardiac exam, acquire and freeze a 2D-mode image. 2. Press the CINE key to activate CINE playback. 3. Roll the trackball through Frame Review to view an end systolic or end diastolic frame. 4. Activate the measurement function. 5. If a list of measurement methods does not display, then select the menu category at the top of the Measurement Menu, and select the name of the list of measurement methods from the available categories (on the right) for the Measurement Menu. For this procedure, select General (2D). 6. If necessary, press the CALIPER key or select a measurement method from the menu to place a measurement marker on the image. The system displays measurement data in the Measured Results. 7. Roll the trackball to position the measurement marker and then press the SET key. The system anchors the marker and displays another measurement marker. 8. Roll the trackball to position the next measurement marker and then press the SET key. The system automatically updates the measurement data in the Measured Results. 9. To assign the measurement data to a label: a.

Select the menu category at the top of the Measurement Menu, and then select the measurement type from the available categories (on the right) for the Measurement Menu.

b. Select the measurement label from the Measurement Menu. The system displays the measurement label and corresponding value in the Measured Results, and assigns the value to the label in the worksheet and the patient report.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 11

B5 Cardiac Measurements and Calculations

Making a 2D-Mode Trace Measurement Use the Trace measurement method to outline a structure such as the mitral valve, the aortic valve, or the left ventricular chamber. The system measures the circumference of the structure and then calculates the area.

[2] Instructions for Use LV Volumes

B5-15

To make a trace measurement: 1. During a Cardiac exam, acquire and freeze a 2D-mode image. 2. Activate the measurement function. The Measurement Menu displays measurement labels. 3. Roll the trackball to select a measurement label in the Measurement Menu that requires the Trace method, and then press the SET key. The system places a measurement marker on the image and displays measurement data for circumference (C) and area (A) in the Measured Results. 4. Roll the trackball to position the measurement marker and then press the SET key. The system anchors the marker. 5. Roll the trackball to create a trace of the structure. To delete (undo) a segment of the outline, rotate the SELECT control on the control panel counterclockwise. 6. To complete the trace, press the SET key. The system displays the measurement label and corresponding value in the Measured Results, and assigns the value to the label in the worksheet and the patient report.

B5 - 12

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac 2D-Mode Left Ventricular Function Assessment Analysis of the heart involves the assessment of the Left Ventricular (LV) function using 2D-mode measurements. The system allows you to select from eight different volume formulas to calculate end-diastolic (EDV) and end-systolic volumes (ESV). The Modified Simpson, Single Plane, Bi-Plane, and Bullet formulas use distance and trace measurements. The Simpson Single Plane measurement type uses the 1Pl Disk volume measurement method. The Cubed, Teichholz, and Gibson formulas use guided measurements for ventricular distances. Volume Method

[2] Instructions for Use Calculation Labels

B5-9

Calculated Results

Menu Label

Description

Simpson Single Plane

Simpson SP

Estimates Volume using the 1Pl Disk measurement at end-diastole and at end-systole for the apical two-chamber view.

EDV mL ESV mL SV mL CO L/min EF % SI mL/m2 CI n/a

Modified Simpson Formula

Mod. Simpson

Estimates Volume using the trace measurement in two different views at end-diastole and at end-systole for sax MV and for sax PM. Also requires a distance measurement of the long axis dimension in an apical four-chamber view at end-diastole and at end-systole:

EDV mL ESV mL SV mL CO L/min EF % SI mL/m2 CI n/a

EDV (mL) = LVLd apical(mm)/9 * (4*LVAd sax MV(cm2) + 2*LVAd sax PM(cm2) + SQRT (LVAd sax MV(cm2) * LVAd sax PM(cm2)) /10) ESV (mL) = LVLs apical(mm)/9 * (4*LVAs sax MV(cm2) + 2*LVAs sax PM(cm2) + SQRT (LVAs sax MV(cm2) * LVAs sax PM(cm2)) /10) Single Plane Formula

Single Plane

Estimates Volume using the trace measurement in a single plane at end-diastole and at end-systole for apical two- or four-chamber view. Also requires a distance measurement of the long axis dimension in an apical view at end-diastole end-systole: EDV = (8÷(3π)) * (LVAd apical(cm2))2 / LVLd apical(mm) * 10

EDV mL ESV mL SV mL CO L/min EF % SI mL/m2 CI n/a

ESV = (8÷(3π)) * (LVAs apical(cm2))2 / LVLs apical(mm) * 10 Bi-plane Formula

Bi-Plane

Estimates Volume using the trace measurement in two planes at end-diastole and at end-systole for apical and for sax MV. Also requires a distance measurement of the LVIDd and the LVIDs: EDV = (8÷(3π)) * LVAd apical(cm2) * LVAd sax MV(cm2) / LVIDd(mm) * 10

EDV mL ESV mL SV mL CO L/min EF % SI mL/m2 CI n/a

ESV = (8÷(3π)) * LVAs apical(cm2) * LVAs sax MV(cm2) / LVIDs(mm) * 10

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 13

B5 Cardiac Measurements and Calculations

Volume Method Bullet Formula

Calculated Results

Menu Label

Description

Bullet

Estimates Volume using the trace measurement in one view at end-diastole and at end-systole for sax MV. Also requires a distance measurement of the long axis dimension in an apical view at end-diastole end-systole. This formula assumes that the left ventricle is shaped like a bullet; the base being cylindrical and the apex cone-like: EDV = (5÷6) * LVLd apical(mm) * LVAd sax MV(cm2) / 10 ESV = (5÷6) * LVLs apical(mm) * LVAs sax MV(cm2) / 10

Cubed Formula

Cubed(2D)

Estimates Volume from the Left Ventricular Internal Diameter (LVID) using the distance measurement: EDV = LVIDd(mm)3 / 1000 ESV = LVIDs(mm)3 / 1000

Teichholz Formula

Teichholz(2D)

Estimates Volume from the Left Ventricular Internal Diameter (LVID) using the distance measurement: EDV(mL) = 7*(LVIDd(mm) * LVIDd(mm) * LVIDd(mm) / 1000) / (2.4 + LVIDd(mm) / 10) ESV(mL) = (7*LVIDs(mm) * LVIDs(mm) * LVIDs(mm) / 1000) / (2.4 + LVIDs(mm) / 10)

Gibson Formula

Gibson(2D)

Estimates Volume from the Left Ventricular Internal Diameter (LVID) using the distance measurement: EDV(mL)= π / 6*(0.98*LVIDd(mm) / 10 + 5.90) * LVIDd(mm) / 10 * LVIDd(mm) / 10 ESV(mL)= π / 6*(1.14*LVIDs(mm) / 10 + 4.18) * LVIDs(mm) / 10 * LVIDs(mm) / 10

B5 - 14

[ 2 ]

EDV mL ESV mL SV mL CO L/min EF % SI mL/m2 CI n/a EDV mL ESV mL SV mL CO L/min EF % FS % SI mL/m2 CI n/a EDV mL ESV mL SV mL CO L/min EF % FS % SI mL/m2 CI n/a EDV mL ESV mL SV mL CO L/min EF % FS % SI mL/m2 CI n/a

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Determining a Left Ventricular End-Diastolic or End-Systolic Volume When a volume measurement label is selected in the Measurement Menu, the default volume measurement method displays at the top, above the name of the measurement type. The Simpson Single Plane measurement type uses the 1Pl Disk volume measurement method.

1Pl Disk Simpson SP EDV ESV

To determine an EDV or ESV: 1. During a Cardiac exam, acquire and freeze a 2D-mode image.

Report Worksheet

2. Press the CINE key to activate CINE playback. 3. Roll the trackball through Frame Review to view an end systolic or end diastolic frame.

Example list of 2D-mode measurement labels for a left ventricular volume measurement type.

4. Activate the measurement function. The Measurement Menu displays measurement labels. 5. Roll the trackball to select a volume measurement label in the Measurement Menu and then press the SET key. The system places a measurement marker on the image, activates the 1Pl Disk volume measurement method, and displays the area (A), circumference (C), diameter (D), and volume (V) of the structure in the Measured Results. 6. Roll the trackball to position the measurement marker to begin the volume trace and then press the SET key. The system anchors the marker. 7. Roll the trackball to create a trace of the structure. To delete (undo) a segment of the outline, rotate the SELECT control counterclockwise. 8. To complete the trace, press the SET key. The system connects the beginning and end points of the trace and displays a line representing the long axis. 9. Roll the trackball to position the endpoint of the long axis and then press the SET key. The system displays the volume in the Measured Results and assigns the volume value to the measurement label.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 15

B5 Cardiac Measurements and Calculations

2D-Mode Guided Measurements The system provides guided measurements for the Cubed, Teichholz, and Gibson measurement types for left ventricular function assessment. Use the system presets to select one of the system-defined guided measurement sequences (patterns) of measurement labels for each measurement type. This procedure describes the complete series of measurements. The measurements can also be performed individually, as non-guided measurements.

System Reference System Presets

Ch 3

F6 M&R ►Measurement and Report Preset ►►Measurement Order

To make a guided LV function measurement: 1. During a Cardiac exam, acquire and freeze a 2D-mode image. 2. Activate the measurement function.

Bullet

3. Select the Cubed(2D), Teichholz(2D), or Gibson(2D) measurement type from the list in the Measurement Menu. The system displays the list of systole and diastole measurement labels in the Measurement Menu. 4. Roll the trackball to highlight Diastole in the Measurement Menu and then press the SET key.

Cubed(2D) Teichholz(2D) Gibson(2D)

Example list of 2D-Mode measurement types.

The system displays a measurement marker on the image and displays labels for the required measurements in the Measured Results. The measurement method, LVDist, displays at the top of the Measurement Menu.

B5 - 16

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

5. Perform the measurements at end-diastole as follows: a.

Roll the trackball to position the marker on the posterior right ventricular wall and then press the SET key. The system anchors the marker and displays the next measurement marker.

b. Set the plane to complete the measurement string. The measurement data for the first distance measurement in the Measured Results updates as you roll the trackball. c.

Roll the trackball to position the second marker on the anterior interventricular septum and then press the SET key. The system anchors the marker, sets the plane for the remaining measurements in diastole, and displays the first distance value in the Measured Results. The measurement data for the second distance measurement in the Measured Results updates as you roll the trackball.

Cubed(2D) LVDist Diastole RVDd IVSd LVIDd LVPWd Systole IVSs LVIDs LVPWs HR Example list of measurement labels for the 2D-Mode Cubed measurement type.

d. Roll the trackball to position the marker on the posterior interventricular septum and then press the SET key. The system anchors the marker and displays the second distance value in the Measured Results. The measurement data for the third distance measurement in the Measured Results updates as you roll the trackball. e. Roll the trackball to position the marker on the endocardium of the left ventricular free wall and then press the SET key. The system anchors the marker and displays the third distance value in the Measured Results. The measurement data for the fourth distance measurement in the Measured Results updates as you roll the trackball. f.

Roll the trackball to position the marker on the posterior left ventricular free wall and then press the SET key. The system anchors the marker, displays the values for RVDd, IVSd, LVIDd, and LVPWd in the Measured Results, and assigns the values to the labels in the worksheet and the patient report. The system also displays the calculated value for EDV in the Measured Results. In the Measurement Menu, the system displays checkmarks next to the completed measurements and highlights Systole as the next suggested measurement.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

Cubed(2D) LVDist E Diastole E RVDd E IVSd E LVIDd E LVPWd Systole IVSs LVIDs LVPWs HR Example list of measurement labels for the 2D-Mode Cubed measurement type, after completing the diastole guided measurements.

B5 - 17

B5 Cardiac Measurements and Calculations

6. To perform systolic measurements, press the SET key. The system displays a measurement marker on the image and displays labels for the required measurements in the Measured Results. 7. Perform the measurements at end-systole as follows: a.

Roll the trackball to position the marker on the anterior interventricular septum and then press the SET key. The system anchors the marker and displays the next measurement marker.

b. Set the plane to complete the measurement string. The measurement data for the first distance measurement in the Measured Results updates as you roll the trackball. c.

Roll the trackball to position the marker on the posterior interventricular septum and then press the SET key. The system anchors the marker, sets the plane for the remaining measurements in systole, and displays the first distance value in the Measured Results. The measurement data for the second distance measurement in the Measured Results updates as you roll the trackball.

d. Roll the trackball to position the marker on the endocardium of the left ventricular free wall and then press the SET key. The system anchors the marker and displays the second distance value in the Measured Results. The measurement data for the third distance measurement in the Measured Results updates as you roll the trackball. e. Roll the trackball to position the marker on the posterior left ventricular free wall and then press the SET key. The system anchors the marker, displays the values for IVSs, LVIDs, and LVPWs in the Measured Results, and assigns the values to the labels in the worksheet and the patient report. The system also displays the calculated value for ESV, SV, EF, FS, and SI in the Measured Results.

B5 - 18

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

To make a non-guided LV function measurement: Note: You can either select a measurement label and then perform the measurement, or perform the measurement and then assign the label to the measured results.

1. During a Cardiac exam, acquire and freeze a 2D-Mode image. 2. Activate the measurement function. 3. Select the Cubed(2D), Teichholz(2D), or Gibson(2D) measurement type from the list in the Measurement Menu. The system displays the list of systolic and diastolic measurement labels in the Measurement Menu. 4. Roll the trackball to highlight any measurement label except Diastole or Systole in the Measurement Menu and then press the SET key. The system displays a measurement marker on the image and displays a distance (D) measurement in the Measured Results. The measurement method, Distance, displays at the top of the Measurement Menu.

Cubed(2D) Distance Diastole RVDd IVSd LVIDd LVPWd Systole IVSs LVIDs LVPWs HR Example list of measurement labels for the 2D-Mode Cubed measurement type, performed as a non-guided measurement.

5. Roll the trackball to position the measurement marker on the image and then press the SET key. The system anchors the marker and displays another measurement marker. 6. Roll the trackball to position the next measurement marker and then press the SET key. The system displays the distance value in the Measured Results and assigns the distance to the selected label. In the Measurement Menu, the system displays a checkmark next to the completed measurement and next to the Diastole or Systole series of measurements. The system also highlights the next measurement in the series. 7. Continue making measurements, as required. When all of the required measurements are made, the system calculates the EDV or ESV and displays the value in the Measured Results along with the values for SV, EF, FS, and SI.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

Cubed(2D) Distance EDiastole RVDd IVSd ELVIDd LVPWd Systole IVSs LVIDs LVPWs HR Example list of measurement labels after the first measurement.

B5 - 19

B5 Cardiac Measurements and Calculations

Cardiac

M-Mode Measurement Labels

System-defined measurement labels for the active Cardiac measurement type display in the Measurement Menu. When a measured result is assigned to a label, the label and value display in the worksheet and the patient report.

System Reference System Presets

Use the system presets to customize the list of measurement labels for a non-guided measurement type, or to select a pattern of labels for a guided measurement type.

Measurement Menu Label

Description

AV/LA

Aortic Valve/Left Atrium function

F6 M&R ►Measurement and Report Preset ►►Measurement Order

Measurement Method

AV Area

Aortic Valve Area

Trace

RV diam

Right Ventricular Diameter

Distance

AO

Aorta

Distance

ACS

Aortic Cusp Separation

Distance

LA diam

Left Atrial Diameter

Distance

LVET

Left Ventricular Ejection Time

Time

LVPEP

Left Ventricular Pre-Ejection Period

Time

Mitral Valve

Mitral Valve function

CE amp

Amplitude of the E wave

Distance

CA amp

Amplitude of the A wave

Distance

DE excursion

Anterior excursion of the mitral leaflet at early diastole.

Slope

DE amp

Amplitude of the DE wave

Distance

EPSS

E Point to Septal Separation. The distance between the anterior leaflet and the ventricular septum at early diastole.

Distance

EF Slope

Deceleration slope of the mitral leaflet's closure at early diastole

Slope

LV Dimensions

Left Ventricle Dimensions

RVDd

Right ventricular dimension at end-diastole

Distance

IVSd

Interventricular septal dimension at end-diastole

Distance

LVIDd

Left ventricular internal dimension at end-diastole

Distance

LVPWd

Left ventricular posterior wall dimension at end-diastole

Distance

IVSs

Interventricular septal dimension at end-systole

Distance

LVIDs

Left ventricular internal dimension at end-systole

Distance

LVPWs

Left ventricular posterior wall dimension at end-systole

Distance

LV Function

Left Ventricle Function

LVET

Left ventricular ejection time

Time

LVPEP

Left ventricular pre-ejection period

Time

B5 - 20

Ch 3

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac

M-Mode Calculation Labels

The system performs M-mode calculations when you complete the required measurements. The resulting values display in the Measured Results and are automatically transferred to the patient report and the Worksheet. Calculation Label

Description

Required Measurements

Units

CI

Cardiac Index is the cardiac output

BSA entry in the patient data form (determined by height and weight of patient)

L/min/m2

Cardiac Output is the effective volume of blood ejected by either ventricle of the heart per unit of time:

EDV ESV HR

L/min

CA amp CE amp

Ratio or Index

LVIDd LVIDs

circ/s

per square meter of body surface area (BSA): CI = CO÷BSA. For height in centimeters and weight in kilograms: BSA=0.007184 x (Weight0.425)x(Height0.725) For height in feet/inches and weight in pounds: BSA=0.007184 x (Weight x 0.454)0.425x(Height x 2.54)0.725

CO

CO = [(EDV - ESV)÷1000](HR). CA/CE

Ratio of the amplitudes of the A wave and the E wave: CA/CE = CA amp(mm)/CE amp(mm)

mVcf

Mean velocity of left ventricular circumferential fiber shortening: mVcf(circ/s) = (LVIDd(mm)-LVIDs(mm))/ (LVIDd(mm)xLVET(ms)/1000)

LVSTI

Left Ventricular Systolic Time Interval is the ratio of the pre-ejection

LVPEP LVET

period to the ejection time:

EDV and ESV

EF

[ 2 ]

I N S T R U C T I O N S

LVSTI = LVPEP(ms)/LVET(ms) Left Ventricular End-Systolic Volume and Left Ventricular End-Diastolic Volume estimate volume from the left ventricular internal diameter (LVID) using the distance measurement. Cubed Volume Method: EDV = LVIDd3 ESV = LVIDs3 Teichholz Volume Method: EDV = 7(LVIDd3 / 1000) / (2.4+LVIDd/10) ESV = 7(LVIDs3 / 1000) / (2.4+LVIDs/10) Gibson Volume Method: EDV = π / 6*(0.98*LVIDd/10+5.90) * LVIDd/10*LVIDd/10 ESV = π / 6*(1.14*LVIDs/10+4.18) * LVIDs/10*LVIDs/10 Ejection Fraction is the ratio of the stroke volume to the end-diastolic volume: EF = 100[(EDV-ESV)÷EDV].

F O R

U S E

LVIDd LVIDs

mL

EDV ESV

%

B5 - 21

B5 Cardiac Measurements and Calculations

Calculation Label AO/LA

Description

Required Measurements

Units

Aortic Ratio to Left Atrium:

LA AO

Ratio or Index

HR a cardiac cycle

bpm

SV BSA

mL/m2

EDV ESV

mL

AO/LA = AO(mm)/LA diam(mm) HR

Heart Rate: HR = 60÷(R-R interval).

SI

SV

B5 - 22

Stroke Index is a measurement of

stroke volume normalized to BSA: SI = SV÷BSA. Stroke Volume is the volume of blood ejected from a ventricle during one cardiac cycle: SV = EDV-ESV.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac

M-Mode Measurement Methods

When the system is in M-mode with the Cardiac exam selected, activating the measurement function causes the system to display M-mode–specific measurement methods.

Making an M-Mode Distance Measurement The distance measurement calculates the length of a straight line between two vertical measurement markers. To label then measure distance: 1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. The Measurement Menu displays measurement labels. 3. Roll the trackball to select a measurement label in the Measurement Menu and then press the SET key. The system places a measurement marker on the image and displays measurement data in the Measured Results. 4. Roll the trackball to position the measurement marker and then press the SET key. The system anchors the marker and displays another measurement marker. 5. Roll the trackball to position the next measurement marker and then press the SET key to complete the measurement. The system displays the distance value in the Measured Results and assigns the distance to the selected label. 6. Continue measurements, as required. The system accommodates up to five measurements for each label in the worksheet.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 23

B5 Cardiac Measurements and Calculations

Making a Heart Rate Measurement This measurement method determines the heart rate by delineating one heart cycle with measurement markers that display as vertical lines. To determine a heart rate: 1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. The Measurement Menu displays measurement labels. 3. Roll the trackball to select the HR measurement label in the Measurement Menu and then press the SET key. The system places a measurement marker on the sweep and displays time (T) and heart rate (HR) values in the Measured Results. 4. Roll the trackball to position the measurement marker on the sweep at the beginning of the cardiac cycle and then press the SET key. The system anchors the marker and displays another measurement marker. 5. Roll the trackball to position the next measurement marker at the end of the cardiac cycle and then press the SET key. The system displays the calculated heart rate in the Measured Results and transfers the value to the Worksheet and the Cardiology Report.

B5 - 24

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Making a Time Measurement The Time method measures the change in time between two points. Time is calculated on the horizontal axis. A measurement marker displays as a vertical line. To label then measure time: 1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. The Measurement Menu displays measurement labels. 3. Roll the trackball to select the LVET or LVPEP measurement label in the Measurement Menu and then press the SET key. The system places a measurement marker on the sweep and displays the time (T) value in the Measured Results. 4. Roll the trackball to position the measurement marker on the image and then press the SET key. The system anchors the marker and displays another measurement marker. 5. Roll the trackball to position the next measurement marker and then press the SET key. The system displays the time value in the Measured Results and assigns the value to the selected label.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 25

B5 Cardiac Measurements and Calculations

Making a Slope Measurement The Slope measurement measures the change in distance over time, as determined by two distance measurement markers. To measure then label a slope: 1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. The Measurement Menu displays measurement labels. 3. Select Slope from the measurement methods. The system places a measurement marker on the sweep and displays the slope (S) value in the Measured Results. 4. Roll the trackball to position the measurement marker on the sweep and then press the SET key. The system anchors the marker and displays the next measurement marker. 5. Roll the trackball to position the second marker then press the SET key. The system displays the slope value in the Measured Results. 6. To assign the measurement data to a label: a.

Select the menu category at the top of the Measurement Menu, and then select the measurement type from the available categories (on the right) for the Measurement Menu.

b. Select the measurement label from the Measurement Menu. The system displays the measurement label and corresponding value in the Measured Results, and assigns the value to the label in the worksheet and the patient report.

B5 - 26

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiac M-Mode Left Ventricular Function Assessment The system provides guided measurements for the Cubed, Teichholz, and Gibson measurement types for left ventricular function assessment. Use the system presets to select one of the system-defined guided measurement sequences (patterns) of measurement labels for each measurement type. These measurements can also be performed individually, as non-guided measurements. To make a guided LV function measurement: 1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. 3. Select the LV/Cubed(M), LV/Teichholz(M), or LV/Gibson(M) measurement type from the list in the Measurement Menu. The system displays the list of systole and diastole measurement labels in the Measurement Menu.

System Reference System Presets

Ch 3

F6 M&R ►Measurement and Report Preset ►►Measurement Order

General(M) LV/Cubed(M) LV/Teichholz(M) LV/Gibson(M) Example list of M-mode measurement types.

4. Roll the trackball to highlight Diastole in the Measurement Menu and then press the SET key. The system displays a measurement marker on the sweep and displays labels for the required measurements in the Measured Results. The measurement method, LVDist, displays at the top of the Measurement Menu. 5. Perform the measurements at end-diastole as follows: a.

Roll the trackball to position the marker on the posterior right ventricular wall and then press the SET key. The system anchors the marker and displays the next measurement marker. The measurement data for the first distance measurement in the Measured Results updates as you roll the trackball.

b. Roll the trackball to position the second marker on the anterior interventricular septum and then press the SET key. The system anchors the marker and displays the first distance value in the Measured Results. The measurement data for the second distance measurement in the Measured Results updates as you roll the trackball. c.

Roll the trackball to position the marker on the posterior interventricular septum and then press the SET key.

LV/Cubed(M) LVDist Diastole RVDd IVSd LVIDd LVPWd Systole IVSs LVIDs LVPWs LVET HR Example list of measurement labels for the M-mode Cubed measurement type.

The system anchors the marker and displays the second distance value in the Measured Results. The measurement data for the third distance measurement in the Measured Results updates as you roll the trackball.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 27

B5 Cardiac Measurements and Calculations

d. Roll the trackball to position the marker on the endocardium of the left ventricular free wall and then press the SET key. The system anchors the marker and displays the third distance value in the Measured Results. The measurement data for the fourth distance measurement in the Measured Results updates as you roll the trackball. e. Roll the trackball to position the marker on the posterior left ventricular free wall and then press the SET key. The system anchors the marker, displays the values for RVDd, IVSd, LVIDd, and LVPWd in the Measured Results, and assigns the values to the labels in the worksheet and the patient report. The system also displays the calculated value for EDV in the Measured Results. In the Measurement Menu, the system displays checkmarks next to the completed measurements and highlights Systole as the next suggested measurement. 6. To perform systolic measurements, press the SET key. The system displays a measurement marker on the sweep and displays labels for the required measurements in the Measured Results.

B5 - 28

[ 2 ]

LV/Cubed(M) LVDist E Diastole E RVDd E IVSd E LVIDd E LVPWd Systole IVSs LVIDs LVPWs LVET HR

Example list of measurement labels for the M-mode Cubed measurement type, after completing the diastole guided measurements.

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

7. Perform the measurements at end-systole as follows: a.

Roll the trackball to position the marker on the anterior interventricular septum and then press the SET key. The system anchors the marker and displays the next measurement marker. The measurement data for the first distance measurement in the Measured Results updates as you roll the trackball.

b. Roll the trackball to position the marker on the posterior interventricular septum and then press the SET key. The system anchors the marker and displays the first distance value in the Measured Results. The measurement data for the second distance measurement in the Measured Results updates as you roll the trackball. c.

Roll the trackball to position the marker on the endocardium of the left ventricular free wall and then press the SET key. The system anchors the marker and displays the second distance value in the Measured Results. The measurement data for the third distance measurement in the Measured Results updates as you roll the trackball.

d. Roll the trackball to position the marker on the posterior left ventricular free wall and then press the SET key. The system anchors the marker, displays the values for IVSs, LVIDs, and LVPWs in the Measured Results, and assigns the values to the labels in the worksheet and the patient report. The system also displays the calculated value for ESV, SV, EF, FS, and SI in the Measured Results. 8. Roll the trackball to highlight LVET in the Measurement Menu and then press the SET key. The system displays a measurement marker on the sweep and displays a time (T) value in the Measured Results. 9. Roll the trackball to position the measurement marker on the image and then press the SET key. The system anchors the marker and displays another measurement marker. 10. Roll the trackball to position the next measurement marker and then press the SET key. The system displays the time value in the Measured Results and assigns the distance to the LVET label.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 29

B5 Cardiac Measurements and Calculations

To make a non-guided LV function measurement: Note: You can either select a measurement label and then perform the measurement, or perform the measurement and then assign the label to the measured results.

1. During a Cardiac exam, acquire and freeze an M-mode sweep. 2. Activate the measurement function. 3. Select the LV/Cubed(M), LV/Teichholz(M), or LV/Gibson(M) measurement type from the list in the Measurement Menu. The system displays the list of systole and diastole measurement labels in the Measurement Menu. 4. Roll the trackball to highlight any measurement label except Diastole or Systole in the Measurement Menu and then press the SET key. The system displays a measurement marker on the sweep and displays a distance (D) measurement in the Measured Results. The measurement method, Distance, displays at the top of the Measurement Menu.

LV/Cubed(M) Distance Diastole RVDd IVSd LVIDd LVPWd Systole IVSs LVIDs LVPWs LVET HR Example list of measurement labels for the M-mode Cubed measurement type, performed as a non-guided measurement.

5. Roll the trackball to position the measurement marker on the image and then press the SET key. The system anchors the marker and displays another measurement marker. 6. Roll the trackball to position the next measurement marker and then press the SET key. The system displays the distance value in the Measured Results and assigns the distance to the selected label. In the Measurement Menu, the system displays a checkmark next to the completed measurement and the set of measurements (Diastole or Systole) to which it belongs. The system also highlights the next suggested measurement. 7. Continue making measurements, as required. When all of the required measurements are made, the system calculates the EDV or ESV and displays the value in the Measured Results.

B5 - 30

[ 2 ]

LV/Cubed(M) Distance E Diastole RVDd IVSd E LVIDd LVPWd Systole IVSs LVIDs LVPWs LVET HR Example list of measurement labels after the first measurement.

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Cardiology Patient Worksheets and Reports The system transfers the labeled measurements and calculations from each Cardiac measurement type into the Cardiology Worksheets and the Cardiology Report. Information from the Patient Data form displays in the top two lines of the patient report. Each Cardiac measurement type has a separate worksheet. Measurements can be edited only in the worksheet, and edited values are indicated in the worksheet and report with an asterisk ( * ).

Using the Cardiology Worksheet The measurements for a measurement type display in the same worksheet even if the measurements are taken in different imaging modes. For example, the AV/LA measurement type uses four distance measurements; if these measurements are made in 2D-mode, they still appear in the same worksheet as the two M-mode time measurements. You can edit measurements directly in the worksheet. When you edit one of the measurements required for a calculation, the system updates the calculated value.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 31

B5 Cardiac Measurements and Calculations

To access a Cardiology Worksheet: 1. During a Cardiac exam, roll the trackball to highlight Worksheet in the Measurement Menu during the measurement function. The system displays the Cardiology Worksheet. 2. To view a different page of the worksheet, roll the trackball to position the pointer on Prev or Next at the bottom of the page and then press the SET key. 3. To return to the image, roll the trackball to position the pointer on Return at the bottom of the page and then press the SET key. To move from the worksheet to the patient report: 1. Display the Cardiology Worksheet. 2. Roll the trackball to position the pointer on Report at the bottom of the report screen, and then press the SET key. The system displays the page of the Cardiology Report for the current measurement type. 3. To access a report page for another measurement type, roll the trackball to position the pointer on the name of the measurement type and then press the SET key. To move from the patient report to the worksheet: 1. Display the Cardiology Report. 2. Roll the trackball to position the pointer on the name of the measurement type and then press the SET key. The system displays the page of the Cardiology Report for the selected measurement type. 3. Roll the trackball to position the pointer on Worksheet at the bottom-right of the report screen, and then press the SET key. The system displays the worksheet for the selected measurement type.

B5 - 32

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Editing Worksheets Edit a worksheet to change the values that display in the patient report and the Measured Results. To change calculated results, edit the measurements that are components of the calculation. The system displays an asterisk ( * ) next to an edited value. If an edited value is used in data averaging, an asterisk displays next to the calculated average.

F6 M&R ►Measurement and Report Preset ►►Display Item

To edit a value in the worksheet: 1. Display the worksheet. 2. Roll the trackball to position the pointer in the cell that you want to edit and then press the SET key. The system highlights the value. 3. Use the keyboard to edit the value and then press the SET key. The system displays an asterisk next to the value. If data averaging is used, the system also displays an asterisk next to the new average value. Note: If the value just edited is used in a calculation, the system displays an asterisk next to the newly-calculated value.

To delete one value for a measurement: 1. Roll the trackball to highlight a value in the worksheet and then press the SET key. 2. Roll the trackball to highlight Delete Cell at the bottom-right of the worksheet and then press the SET key. The system clears the selected cell in the worksheet. If data averaging is used, the system updates the averaged value based on the remaining measurements.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 33

B5 Cardiac Measurements and Calculations

To delete all values for a measurement: 1. Roll the trackball to highlight a value in the worksheet and then press the SET key. 2. Roll the trackball to highlight Delete Line at the bottom-right of the worksheet and then press the SET key. The system displays a verification message. 3. Roll the trackball to OK and then press the SET key. The system removes all values for that measurement from the Worksheet. Note: If the value just deleted is used in a calculation, the system removes the calculated value from the worksheet and the Measured Results.

To delete all values for a measurement type: 1. Roll the trackball to highlight Delete All at the bottom-right of the worksheet and then press the SET key. The system displays a verification message. 2. Roll the trackball to position the pointer on OK and then press the SET key. The system removes all values for all measurements from the worksheet, and clears the page in the report for that measurement type.

B5 - 34

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 Cardiac Measurements and Calculations

Using the Cardiology Report The measurements for a measurement type display on the same report page even if the measurements are taken in different imaging modes. To access the Cardiology Report: 1. During a Cardiac exam, press the F2 key on the keyboard or roll the trackball to highlight Report in the Measurement Menu and then press the SET key. The system displays the first page of the Cardiology Report. 2. To access a different report page, roll the trackball to position the pointer on Prev or Next at the bottom of the report and then press the SET key. 3. To redisplay the image screen, press the ESCAPE key or roll the trackball to position the pointer on Return at the bottom of the report and then press the SET key.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

B5 - 35

B5 Cardiac Measurements and Calculations

To add comments to a report: 1. Access the patient report. 2. Roll the trackball to position the pointer in the Comments field and then press the SET key. Note: When adding new comments to existing comments, roll the trackball to position the pointer at the end of the existing text in the Comments field and then press the SET key.

3. Use the keyboard to add new comments or edit the existing comments. Note: Enter your comments as a single paragraph. Do not use the Enter key on the keyboard to separate lines of comments.

To add comments from the system presets to a report: 1. Roll the trackball to position the pointer on Comments, and then press the SET key. The system displays the list of comments from the presets in the Comments Dialog. 2. Roll the trackball to highlight the comment and then press the SET key. 3. Roll the trackball to position the pointer on OK and then press the SET key. The system places the selected text in the Comments field.

System Reference

4. Repeat steps 2 and 3 as required to annotate the report. Note: When adding new comments to existing comments, roll the trackball to position the pointer at the end of the existing text in the Comments field and then press the SET key.

B5 - 36

[ 2 ]

Documentation Devices

I N S T R U C T I O N S

Ch 4

F O R

U S E

C1 Transducer Accessories Transducer Accessories ..................................................................................... 3 Transducer Sheaths....................................................................................... 4 General Information Sheaths ............................................................... 4 Application Sheaths ............................................................................. 5 Disposal Sheaths ................................................................................. 5 Gel Pad .......................................................................................................... 6 Preparation for use ................................................................................. 6 Disposal Gel Pad.................................................................................. 6 Needle Guide Brackets.................................................................................. 7 EC9-4 Disposable Needle Guide Kit ....................................................... 7 EC9-4 Stainless Steel Needle Guide Kit ................................................. 7 Universal Needle Guide S....................................................................... 8 6.5EV13 Needle Guide Bracket Kit (EV9-4)........................................... 12 S-Array Needle Guide Bracket Kits (7.5L75S)....................................... 14

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 1

C1 Transducer Accessories

C1 - 2

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

Transducer Accessories Attachment procedures for the following accessories are presented in this chapter or are shipped separately with the device. Accessories are arranged by transducer type in the following table:

[1] Instructions for Use Cleaning and Care

Ch 2

Accessory

Curved Array

Linear Array

Mechanical Sector

Transducer Sheath

All

All

All

Gel Pad

L10-5 7.5L75S

Universal Needle Guide S

C4-2 C5-2 C8-5

6.5EV13 Needle Guide Bracket Kit

EV9-4

S-Array Needle Guide Bracket Kit

L10-5

7.5L75S

EC9-4 Disposable Needle Guide Kit

EC9-4

EC9-4 Stainless Steel Needle Guide Kit

EC9-4

Endo-V II Needle Guide Bracket Kit

Endo-V II

Endo-P II Needle Guide Bracket Kit

Endo-P II

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 3

C1 Transducer Accessories

Transducer Sheaths Siemens makes every effort to manufacture safe and effective transducers. You must take all necessary precautions to eliminate the possibility of exposing patients, operators, or third parties to hazardous or infectious materials. These precautions should be considered in the use of any application that may indicate the need for such care, and during endocavity or intraoperative scanning; during biopsy or puncture procedures; or when scanning patients with open wounds.

General Information

[2] Instructions for Use Endo-P II

Ch C3

Sheaths

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. WARNING: Only a sterile transducer sheath provides the sterile barrier required for surgical or puncture procedures. To ensure sterility of a procedure, always place a sterile sheath on a transducer as transducers cannot be sterilized using hot steam, cold gas, or Ethylene Oxide (ETO) methods.

Transducer sheaths are single-use items used to ensure proper acoustic coupling and provide a prophylactic barrier for the intended ultrasound application. Sheaths are available for all transducers. Siemens recommends the use of market-cleared transducer sheaths.

C1 - 4

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

Application

Sheaths

Step-by-step instructions are provided for both non-sterile and sterile procedures. To place the transducer in a sheath for non-sterile use: Before applying any coupling agent (gel) to the sheath, remove any powder in the sheath by rinsing with water. 1. Remove the packaging and unfold the transducer sheath. 2. Apply a water-based coupling agent (gel) to the inside of the sheath and onto the face of the transducer.

7.5L40

3. Hold the transducer by the cable relief and unroll the sheath onto the transducer. 4. Pull the transducer sheath tightly over the face of the transducer to remove wrinkles. 5. Secure the sheath to the transducer housing or cable relief with the adhesive tapes or elastic bands provided.

7.5L40

To place the transducer in a sheath for sterile use: Before applying any sterile coupling agent (gel) to the sheath, remove any powder in the sheath by rinsing with sterile water. 1. Using sterile technique, remove the packaging and unfold the transducer sheath. 2. Taking care not to contaminate the sheath, apply a sterile water-based coupling agent (gel) to the inside of the sheath and onto the face of the transducer. 3. Using sterile technique, hold the transducer by the cable relief and unroll the sheath onto the transducer and cable. 4. Pull the transducer sheath tightly over the face of the transducer to remove wrinkles. 5. Secure the sheath to the transducer cable with the adhesive tapes or elastic bands provided. WARNING: After placing the sheath over the transducer, visually inspect the sheath to ensure there are no defects. Do not use the sheath if it has any holes or tears.

Disposal

Sheaths

While wearing protective gloves, remove the transducer sheath from the transducer and dispose of it according to medical regulations for biohazardous waste.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 5

C1 Transducer Accessories

Gel Pad [2] Instructions for Use

The gel pad is a disposable bacteriostatic standoff. It is used when superficial imaging requires an appropriate standoff for utilizing the focal zone of the transducer. The gel pad provides a fixed distance between the transducer face and the body surface.

Compatible Transducers

C1-3

WARNING: Ultrasound energy is transmitted more efficiently through the gel pad than through tissue. When using a standoff device of any kind, for example a waterpath or gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher than indicated in the output display on the system.

Preparation for use Before use, examine the gel pad for any material flaws. Any product showing flaws should not be used.

Disposal

Gel Pad

While wearing protective gloves, remove the gel pad from the transducer and dispose of it according to medical regulations for biohazardous waste.

C1 - 6

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

Needle Guide Brackets WARNING: Percutaneous procedures always involve heightened risk to the patient and to the operator handling biopsy needle guides. Clinicians using Siemens recommended biopsy devices under ultrasound guidance should be trained and must observe proper needle insertion sequencing with the needle guide in order to avoid undue discomfort and unnecessary risk and injury to the patient.

[2] Instructions for Use Endo-V II Endo-P II

Ch C2 Ch C3

EC9-4 Disposable Needle Guide Kit Refer to the in-box instructions for attachment and care procedures.

EC9-4 Stainless Steel Needle Guide Kit Refer to the in-box instructions for attachment and care procedures, including cleaning and sterilization.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 7

C1 Transducer Accessories

Universal Needle Guide S [2] Instructions for Use

The Universal Needle Guide is a stainless steel transducer accessory used for biopsy and needle puncture procedures.

Compatible Transducers

C1-3

The Universal Needle Guide S consists of a needle bracket and three (3) needle caps. The needle caps are designed for quick release. Components of the Universal Needle Guide S

needle bracket

needle cap

The needle bracket and needle cap have a single angle. When the needle cap is attached to the bracket, a needle channel is created. This channel secures needles in the needle guide. The needle caps are labeled with the needle size. Needle caps are provided for the following needle sizes: 0.9 mm (20 gauge) 1.2 mm (18 gauge) 1.8 mm (15 gauge) Note: The Universal Needle Guide S supports only the needle sizes in the above list.

Preparation for Use

Universal Needle Guide S [2] Instructions for Use

WARNING: Do not attempt to use the needle guide until you have read the following instructions. The needle guide should only be used after proper training and after verifying the path of the needle.

Needle Path Verification

Ch A4

WARNING: The needle guide kit is packaged non-sterile. Sterilize these components prior to the first use. [1] Instructions for Use

WARNING: Ensure that the needle guide components are properly cleaned and sterilized before each use to avoid possible patient contamination.

Cleaning and Care Sterilization

Ch 2 Ch 2

WARNING: Before attaching the needle guide to the transducer, place the transducer in a sterile transducer sheath. WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. Caution: Use only a water-based ultrasound coupling agent (gel) with this kit. Petroleum- or mineral oil-based materials can harm the transducer.

C1 - 8

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

To attach the needle cap to the needle bracket: 1. Place a sterile transducer sheath over the transducer. 2. Select the needle cap that matches the size of the needle to be used in the procedure. The needle size is marked on each needle cap.

[2] Instructions for Use Transducer Sheaths

C1-4

3. Place the needle cap into the raised edge on the needle bracket, and then snap the needle cap onto the bracket. This secures the cap to the bracket and forms the needle channel.

Attaching the needle cap to the needle bracket.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 9

C1 Transducer Accessories

To attach the needle guide to the transducer: After the needle cap is attached to the needle bracket, attach the needle guide to the transducer. Using sterile technique: 1. Loosen the thumb screw on the needle guide. Attach the needle guide to the grooves on the side of the transducer housing. Note: For illustration purposes only, the transducer is shown without a transducer sheath. Always place a sterile transducer sheath over the transducer.

Attaching the needle guide to the transducer.

2. Gently tighten the thumb screw to firmly secure the needle guide. Caution: Excessive force could harm the transducer.

3. Insert the needle into the channel on the needle guide. [2] Instructions for Use

The needle must be the correct size for the needle guide. 4. Before performing any patient procedure, verify the needle path.

C1 - 10

[ 2 ]

Needle Path Verification

I N S T R U C T I O N S

Ch A4

F O R

U S E

C1 Transducer Accessories

Detachment Procedure

Universal Needle Guide S

Before you remove the needle guide from the transducer, remove the needle cap from the needle bracket. To remove the needle cap from the needle bracket: 1. Push down with the thumb and up with the index finger on the tabs to release the needle cap. 2. Pull the needle cap away from the bracket.

Detaching the needle cap from the needle bracket.

To remove the needle guide from the transducer: 1. Loosen the thumb screw on the needle guide. 2. Lift the needle guide up and away from the transducer.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 - 11

C1 Transducer Accessories

6.5EV13 Needle Guide Bracket Kit (EV9-4) The 6.5EV13 Needle Guide Bracket Kit consists of a needle guide and two cleaning brushes. You can use the needle guide with needle sizes ranging from 16 to 22 gauge (1.60 mm to 0.7 mm).

[2] Instructions for Use Compatible Transducers

C1-3

Example of the 6.5EV13 Needle Guide. Note: The EV9-4 transducer has been designed to function properly with the 6.5EV13 Needle Guide Bracket Kit.

Preparation for Use

6.5EV13 Needle Guide Bracket Kit

WARNING: Do not attempt to use the Needle Guide Bracket Kit until you have read the following instructions. The needle guide should only be used after proper training and after verifying the path of the needle.

[2] Instructions for Use Needle Path Verification

Ch A4

WARNING: The needle guide is packaged non-sterile. Sterilize this product prior to its first use. WARNING: Ensure that the needle guide is properly cleaned and sterilized before each use to avoid possible patient contamination. [1] Instructions for Use

WARNING: Before attaching the needle guide to the transducer, place the transducer in a sterile transducer sheath.

Cleaning and Care Sterilization

Ch 2 Ch 2

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. Caution: Use only a water-based ultrasound coupling agent (gel) with this kit. Petroleum- or mineral oil-based materials can harm the transducer.

C1 - 12

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

To attach the needle guide to the transducer: WARNING: Care must be taken to ensure that the needle guide is properly positioned. When properly positioned, the bracket will cover the colored ring on the transducer handle and the hook will be firmly against the transducer tip.

[2] Instructions for Use Transducer Sheaths

C1-4

1. Place a sterile transducer sheath over the transducer. To ensure an accurate scan, there should not be any air bubbles or wrinkles between the transducer face and the transducer sheath. 2. Loosen the thumb screw in the needle guide bracket. 1

4

2

1 2 3 4

Bracket Thumb screw Raised bar Hook

3

3. Lift up the thumb screw to open the bracket. Notice the raised bar on the inside of the bracket end of the needle guide. In step 4, this bar must fit in the notch on the colored ring on the transducer handle. 4. Place the hook over the middle of the transducer's shaft and then slide it up the length of the shaft.

Note: For illustration purposes only, the transducer is shown without a transducer sheath. Always place a sterile transducer sheath over the transducer.

When properly positioned, the bracket must cover the colored ring and the raised bar fits in the notch.

5. Close the bracket, reposition and tighten the thumb screw.

6. Before performing any patient procedure, verify the needle path.

[2] Instructions for Use Needle Path Verification

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

Ch A4

C1 - 13

C1 Transducer Accessories

S-Array Needle Guide Bracket Kits (7.5L75S) The S-Array Needle Guide Bracket Kit is a transducer accessory used for biopsy and needle puncture procedures. Components of the Needle Guide Kit

Bracket

Needle Guide Holder

[2] Instructions for Use Compatible Transducers Universal Needle Guide S Needle Path Verification

C1-3 C1-8 Ch A4

[1] Instructions for Use

The Needle Guide Bracket Kit consists of the bracket and five needle guide holders.

Cleaning and Care

Ch 2

You must order both a Needle Guide Bracket Kit and a Needle Guide Set for use with your transducer. Needle guide sets contain three (3) pieces. The needle guide supports the following needle sizes: 0.9 mm (20 gauge) 1.3 mm (18 gauge) 1.8 mm (16 gauge) 2.3 mm 2.5 mm Note: The needle guide supports only the needle sizes shown in the above list.

Example of a Needle Guide.

C1 - 14

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C1 Transducer Accessories

Preparation for Use

S-Array Needle Guide

WARNING: Do not attempt to use the Needle Guide Bracket Kit until you have read the following instructions. The needle guide should only be used after proper training and after verifying the path of the needle according to the needle path verification procedure.

[2] Instructions for Use Needle Path Verification

Ch A4

WARNING: Needle Guide Bracket Kits are packaged as non-sterile. Sterilize these products prior to their first use. WARNING: Ensure the components of the Needle Guide Bracket Kit are properly cleaned and sterilized before each use to avoid possible patient contamination. WARNING: To ensure a proper fit, always use a polyethylene- or CIV-FLEX™type transducer sheath with the S-Array Needle Guide Bracket Kit. Do not use a latex transducer sheath. CIV-FLEX™ sheaths can be ordered through Civco Medical Instruments Co., Inc., Kalona, Iowa, 1-800-445-6741. WARNING: The needle guide holder should fit securely against the needle guide bracket. Evaluate the fit of the needle guide holder and bracket prior to each use. After continued use, the fit of the needle guide holder to the bracket will deteriorate. Should this occur, replace the S-Array Needle Guide Bracket Kit. CAUTION: Use only a water-based ultrasound coupling agent (gel) with this kit. Petroleum- or mineral oil-based materials can harm the transducer.

To attach the bracket to the transducer: 1. Position the bracket on the transducer. When correctly positioned, the finger grooves on the bracket should fit into the indentation on the transducer, and the clasp should be on the side of the transducer with the raised colored dot.

1

1

2

Indicator of compatible transducer type Colored dot

2 Attaching the bracket to the transducer.

2. Engage the clasp on the bracket to secure the bracket to the transducer. 3. Apply coupling agent (gel) to the face of the transducer. 4. Place a sterile polyethylene- or CIV-FLEX™-type transducer sheath over the transducer. To ensure an accurate scan, there should not be any air bubbles or wrinkles between the transducer face and the transducer sheath.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

[2] Instructions for Use Transducer Sheaths

C1-4

C1 - 15

C1 Transducer Accessories

To attach the needle guide holder to the bracket: 1. Place the holder into the raised edge on the bracket and pivot the guide until it clicks into position. The needle guide holder should rest securely against the bracket.

Attaching the holder to the bracket.

2. Select the appropriate needle guide for the intended needle size to be used in the procedure. 1

1

Peg

Needle Guide.

3. Insert the needle guide into the appropriate angle track. For curved array needle guide bracket kits, the three angle tracks are 25°, 35°, and 45°. For linear array needle guide bracket kits, the three angle tracks are 40°, 50°, and 60°. 4. Rotate the needle guide until the peg rests against the needle guide holder. When correctly installed, the needle channel should not be exposed.

Securing the needle guide against the holder.

5. Insert the needle into one of the three channels on the guide. [2] Instructions for Use

The needle must be the correct size for the needle guide. 6. Before performing any patient procedure, verify the needle path.

C1 - 16

[ 2 ]

Needle Path Verification

I N S T R U C T I O N S

Ch A4

F O R

U S E

C2 Endo-V II Transducer Mechanical Sector Endo-V II Transducer ........................................................ 3 Note on Fetal Examinations........................................................................... 4 Transducer Markings ..................................................................................... 5 Transducer Handle ................................................................................. 5 Preparation for Use........................................................................................ 6 Using a Protective Sheath ...................................................................... 6 Connecting the Transducer .................................................................... 7 Activating the Endo-V II Transducer....................................................... 8 Imaging with the Endo-V II Transducer ......................................................... 9 Changing the Transmit Frequency.......................................................... 9 2D/M-Mode Display and Update ............................................................ 9 Changing the Field of View .................................................................. 10 Changing the Image Orientation........................................................... 11 Technical Data Mechanical Sector Endo-V II Transducer........................... 12 Endo-V II Needle Guide Bracket Kit ............................................................... 13

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 1

C2 Endo-V II Transducer

C2 - 2

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Mechanical Sector Endo-V II Transducer (Requires software version 2.0 or higher) WARNING: Before attempting to use endocavity transducers, you should be trained in ultrasonography and endocavity scanning techniques, and you should be thoroughly familiar with the safe operation of the ultrasound imaging system.

The Endo-V II transducer is a mechanical sector ultrasound transducer with rotating crystals for real-time imaging. The Endo-V II transducer is designed for endovaginal imaging of the general pelvic region, such as during the early stages of pregnancy, for detection of ectopic pregnancies, and for examination of the follicles, ovaries, fallopian tubes, inner cavities, bladder, and uterus.

[1] Instructions for Use Cleaning and Care Ch 2 Storage Ch 6

The Endo-V II transducer is intended for use with the ultrasound imaging system in 2D-mode and M-mode. You can use the transducer to acquire images in Dual mode, Split mode (B+B), 4B-mode, and 2D/M-mode. The acoustic portion of the transducer consists of two acoustic elements, one 5.0-MHz element and one 7.5-MHz element. A third frequency of 6.0 MHz is provided by excitation of the 7.5-MHz crystal with a 5.0-MHz transmit pulse. You can use these frequencies to optimize the imaging capability for different depth-dependent areas of interest. The transducer samples a 220° maximum sector angle. The position of the field of view is represented on the image screen by the shaded section of the Endo-V II symbol. The Endo-V II symbol has a hook that indicates the active scan direction.

100o 220o

On-screen symbol for the Endo-V II transducer.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 3

C2 Endo-V II Transducer

Note on Fetal Examinations The following recommendation is excerpted from the National Institute of Health's Consensus Statement on the Use of Ultrasound Imaging During Pregnancy, Volume 5, No. 1, based on the recommendation issued at the Health Consensus Development Conference, February, 1984: Ultrasound examination in pregnancy should be performed for a specific medical indication. The data on clinical efficacy and safety do not allow a recommendation for routine scanning at this time. Ultrasound examination performed solely to satisfy the family's desire to know the fetal sex, to view the fetus, or to obtain a picture of the fetus should be discouraged. In addition, visualization of the fetus solely for educational or commercial demonstrations without medical benefit should not be performed.

C2 - 4

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Transducer Markings The Endo-V II transducer is designed with an orientation indicator on the handle of the transducer.

Transducer Handle An indentation on the handle of the transducer provides you with an orientation reference to the echo in the image.

Example of Orientation Indicator on Transducer Handle.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 5

C2 Endo-V II Transducer

Preparation for Use WARNING: Ensure the transducer is properly cleaned and high-level disinfected before use to avoid possible patient contamination.

[1] Instructions for Use Cleaning and Disinfecting

Ch 2

Using a Protective Sheath WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and be prepared to treat allergic reactions promptly. For additional information, refer to FDA Medical Alert MDA91-1.

[2] Instructions for Use Transducer Sheaths

Ch C1

For patient and operator safety, cover the Endo-V II transducer with a protective cover at all times during use.

C2 - 6

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Connecting the Transducer Caution: When moving the system, disconnect the transducer and transport it separately in the transducer case provided. Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the transducer. Turn the connector lock counter-clockwise, and pull the connector by holding onto the housing. Note: Always freeze the system when connecting or disconnecting the Endo-V II transducer. Note: Place the transducer in the transducer holder on the system or in its carrying case when not in use.

Mechanical sector port.

To connect a mechanical sector transducer: 1. Insert the connector pins into the system port. Adjust the connector until you can turn the lever on the transducer connector clockwise to lock it in position. This secures the connector in position and ensures the best possible contact. 2. Place the transducer in the transducer holder and drape the cable through the cable hangers.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 7

C2 Endo-V II Transducer

Activating the Endo-V II Transducer Although multiple transducers can be connected to the ultrasound system, only one transducer can be active. Use the system presets to select the transducer port that will be active at system power-on.

System Reference System Presets

Ch 3

F6 Boot Up ► Transducer Port Active On Boot Up

To activate a transducer connected to the system: 1. Press the TRANSDUCER key located on the control panel. The name of the active transducer displays on the upper left of the screen. 2. To activate another transducer connected to the system, press the TRANSDUCER key again.

C2 - 8

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Imaging with the Endo-V II Transducer The Endo-V II transducer supports all of the functions and controls that are available in 2D-mode and M-mode. When you have acquired an image, you can change the orientation of the image, make measurements and calculations, annotate with pictograms or text, or perform a biopsy or puncture procedure.

Changing the Transmit Frequency

[2] Instructions for Use Pictograms Ch Imaging Functions Ch Measurements and Calculations Ch OB Measurements and Calculations Ch EM Measurements and Calculations Ch

A1 A3 B1 B2 B3

Push the MULTIHERTZ control on the control panel up to increase the frequency or down to decrease the frequency. The system uses the next available frequency, 5.0 MHz, 6.0 MHz, or 7.5 MHz, for imaging. The system displays the name of the active transducer and operating frequency in the upper left of the image screen.

2D/M-Mode Display and Update For mechanical sector transducers, the system defaults to a periodically refreshed 2D-mode image with a real-time M-mode sweep. The 2D-mode image is frozen until the M-mode sweep is complete. The M-mode sweep then freezes while the 2D-mode image is refreshed, and then displays again in real time. Use the system presets to set the refresh rate for mechanical sector transducers.

System Reference System Presets

Ch 3

F6 Imaging ► Update Frames in 2D/M

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 9

C2 Endo-V II Transducer

Changing the Field of View The Endo-V II transducer is designed for imaging in a maximum 220° field of view. You can select a structure of interest anywhere in the 220° scan plane. A graphic, the Endo-V II symbol, represents the transducer's 220° field of view for the endovaginal transducer. The symbol displays on the right side of the image screen. Within the symbol is a shaded sector that represents the active imaging sector. You may place the shaded sector anywhere within the Endo-V II symbol. This use of the trackball steers the on-screen image.

100o 220o

On-screen symbol for the Endo-V II transducer.

The hook at the top of the symbol represents changes in the scanning direction of the transducer. Echo Survey section right

Survey section left Orientation Indicator Survey end-fire direction

C2 - 10

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Use the system presets to remove or display the scan plane icon on the image screen.

System Reference System Presets

Ch 3

To select the sector angle: 1. Press the MENU key on the control panel when 2D-mode is active. F6

2. Roll the trackball to Scan Angle on the 2D-mode menu. The current angle setting displays next to the selection. The scan angle on the ultrasound system represents the imaging sector. The available angle selections are 80°, 110°, 160°, and 220°.

Display ► Scan Plane Icon

3. Select the scan angle by rotating the SELECT control on the control panel. 4. Roll the trackball to place the imaging sector within the field of view for the active plane.

Changing the Image Orientation You can change the image orientation by rotating the image and by changing the scan direction.

90°

180°

270°

Image Orientation

To rotate the image: Press and hold the SHIFT key on the keyboard and then press the L/R FLIP button on the control panel to rotate the image 90° clockwise. To change the scan direction: Press the L/R FLIP button on the control panel.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 11

C2 Endo-V II Transducer

Technical Data Mechanical Sector Endo-V II Transducer Transducer type:

Mechanical Sector (two rotating crystals)

Frequency range:

5.0 to 7.5 MHz

Focus:

5.0 MHz: 30 ±5 mm 7.5 MHz: 25 ±5 mm

Operating modes:

2D, Dual, Split (B+B), 4B, M, 2D/M

Maximum displayable field of view:

220°

Sector angle:

80°, 110°, 160°, 220°

Scanning direction:

Right/left Bottom, 90°, 180°, 220° image rotation

Orientation:

On-screen graphical icon indicates sectional orientation.

Operating environment:

+20°C to +40°C

Storage:

-5°C to +50°C

Humidity:

Up to 80% relative humidity

C2 - 12

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 Endo-V II Transducer

Endo-V II Needle Guide Bracket Kit The optional stainless steel, reusable needle guide attachment provides the ability to perform biopsy procedures with the Endo-V II sector transducer. Two different sizes of attachments are available: one supports needle sizes up to 18 gauge/1.2 mm and the other supports needle sizes up to 16 gauge/1.6 mm.

[2] Instructions for Use Compatible Transducers

Ch C1

Example of the Endo-V II Needle Guide.

Preparation for Use

Endo-V II Needle Guide Bracket Kit

WARNING: Do not attempt to use the Needle Guide Bracket Kit until you have read the following instructions. The needle guide should only be used after proper training and after verifying the path of the needle.

[2] Instructions for Use Needle Path Verification

Ch A4

WARNING: The needle guide is packaged non-sterile. Sterilize this product prior to its first use. WARNING: Ensure that the needle guide is properly cleaned and sterilized before each use to avoid possible patient contamination. WARNING: Before attaching the needle guide to the transducer, place the transducer in a sterile transducer sheath.

[1] Instructions for Use Cleaning and Care Ch 2 Sterilization Ch 2

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. Caution: Use only a water-based ultrasound coupling agent (gel) with this kit. Petroleum- or mineral oil-based materials can harm the transducer.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C2 - 13

C2 Endo-V II Transducer

To attach the needle guide to the transducer: WARNING: Care must be taken to ensure that the needle guide is properly positioned. When properly positioned, the bracket will cover the colored ring on the transducer handle and the hook will be firmly against the transducer tip.

[2] Instructions for Use Transducer Sheaths

Ch C1

1. Place a sterile transducer sheath over the transducer. To ensure an accurate scan, there should not be any air bubbles or wrinkles between the transducer face and the transducer sheath. 2. Loosen the thumb screw in the needle guide bracket.

1 2 3

Bracket Thumb screw Hook

3. Lift up the thumb screw to open the bracket. Place the screw on the outside of the bracket Notice the bumps on the inside of the bracket end of the needle guide. These bumps must fit in the indentations above the colored ring on the transducer handle.

Note: For illustration purposes only, the transducer is shown without a transducer sheath. Always place a sterile transducer sheath over the transducer.

4. Place the hook over the middle of the transducer's shaft and then slide it up the length of the shaft. 5. Align the lower edge of the bracket with the lower edge of the colored ring on the transducer handle.

6. Align the bumps on the inside of the bracket with the indentations above the colored ring on the transducer handle. When properly positioned, the bracket must cover the colored ring and the raised bar fits in the notch. 7. Close the bracket, reposition and tighten the thumb screw. 8. Before performing any patient procedure, verify the needle path.

[2] Instructions for Use Needle Path Verification

C2 - 14

[ 2 ]

I N S T R U C T I O N S

Ch A4

F O R

U S E

C3 Endo-P II Transducer Mechanical Sector Endo-P II Transducer......................................................... 3 Scan Planes ................................................................................................... 4 Transverse Scan Plane Symbol .............................................................. 5 Longitudinal Scan Plane Symbol............................................................. 6 Plane Cursor ........................................................................................... 7 Transducer Markings and Indicators.............................................................. 8 Transducer Shaft .................................................................................... 8 Transducer Handle ................................................................................. 9 Preparation for Use...................................................................................... 10 Using a Protective Sheath .................................................................... 10 Connecting the Transducer .................................................................. 11 Activating a Transducer................................................................................... 12 Imaging with the Endo-P II Transducer ....................................................... 13 Changing the Transmit Frequency........................................................ 13 2D/M-Mode Display and Update .......................................................... 13 Selecting the Sector Angle and Adjusting the FOV .............................. 14 Changing the Image Orientation........................................................... 15 Selecting a Scan Plane ......................................................................... 16 Measurements and Calculations .......................................................... 18 Biopsy or Puncture Procedures ............................................................ 18 Endo-P II Transducer Accessories .................................................................. 19 Endo-P II Needle Guide Kit .................................................................. 19 Preparation for Use .............................................................................. 19 Technical Data Mechanical Sector Endo-P II Transducer.......................... 22

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 1

C3 Endo-P II Transducer

C3 - 2

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Mechanical Sector Endo-P II Transducer (Requires software version 2.0 or higher) WARNING: To reduce the risk of electrical shock, you must use the protective sheaths that are specified in the Endo-P II transducer kit number 10030776. You must refer to the in-box instructions for proper application of the protective sheath. WARNING: Before attempting to use endocavity transducers, you should be trained in ultrasonography and endocavity scanning techniques, and you should be thoroughly familiar with the safe operation of the ultrasound imaging system. WARNING: To avoid electrical shock to the patient, you must visually inspect the transducer prior to each use. Examine the entire transducer with particular attention to the transducer tip. Do not use the transducer if the transducer tip is cracked or shows signs of fluid leakage. Do not use a transducer which has a cracked, punctured, or discolored casing or a frayed cable.

Discoloration Exception: The use of Cidex OPA and Gigasept FF disinfectants may cause discoloration of transducer housings. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

[1] Instructions for Use Approved List of Disinfectants

Ch 2

The Endo-P II transducer is intended for use with the ultrasound imaging system in 2D-mode and M-mode. You can use the transducer to acquire images in Dual mode, Split mode (B+B), 4B-mode, and 2D/M-mode. The Endo-P II transducer is a mechanical sector ultrasound transducer with rotating crystals for real-time imaging. The Endo-P II transducer is designed for adult endorectal sonography of the rectum, prostate, bladder, and urethra. The acoustic portion of the transducer consists of two acoustic elements; one operates at a frequency of 5.0 MHz, and the other at 7.5 MHz. A third frequency of 6.0 MHz is provided by excitation of the 7.5-MHz crystal with a 5.0-MHz transmit pulse, resulting in 6.0-MHz imaging. You can use these frequencies to optimize the imaging capability for different depth-dependent areas of interest.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 3

C3 Endo-P II Transducer

Scan Planes The Endo-P II transducer enables you to view an area of interest in both the transverse and longitudinal planes, without having to reposition the transducer. Instead, you can use the trackball and on-screen graphics to position an active imaging sector. The transverse plane can provide a 355° field of view and the longitudinal plane can provide a 240° field of view. The scan planes are represented as graphical symbols on the image screen. The system automatically displays both scan plane symbols on the image screen when you activate the Endo P-II transducer. 1

12

3

.

9

2

.

6

.

3

. . .

Longitudinal scan plane symbol Transverse scan plane symbol In-line cursor indicates the orientation of the transverse plane in relation to the longitudinal plane

. . In this example, the Endo-P II transducer is scanning in the longitudinal plane as indicated by the shaded sector in the longitudinal plane symbol on the upper left.

C3 - 4

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Transverse Scan Plane Symbol 12

9

The transverse plane symbol is a circle representing the transducer's field of view.

3

6

Transverse Plane Symbol and Transverse Plane.

The transverse plane is the initial plane for the Endo-P II transducer. By rolling the trackball, you can position the shaded sector anywhere within the field of view. This use of the trackball steers the field of view. The shaded sector shown in the transverse plane symbol is relative to the position of the transducer. SIEMENS 12 3

9 6

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

When the transverse plane is active, a shaded sector, representing the active imaging sector, displays within the transverse scan plane symbol.

C3 - 5

C3 Endo-P II Transducer

Longitudinal Scan Plane Symbol

Longitudinal Plane Symbol and Longitudinal Plane.

The longitudinal scan plane symbol represents the Endo-P II transducer's 240° field of view in the longitudinal plane. By rolling the trackball, you can move the sector anywhere within the 240° scan plane. This use of the trackball steers the field of view. SIEMENS

C3 - 6

12

3

9

. . . . . . . .

When the longitudinal plane is active, a shaded sector, representing the active imaging sector, displays within the longitudinal scan plane symbol.

6

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Plane Cursor 1

Both the transverse and longitudinal plane symbols display a plane cursor when that plane is active. The plane cursor indicates the position of the two planes relative to each other, representing the line where the active plane is intersected by the alternate plane at a 90° angle. 12

When you change planes from transverse to longitudinal, the transducer acquires the active imaging sector at the position of the plane cursor in the transverse plane symbol. For this reason, ensure that the plane cursor protrudes through the shaded sector in the active plane symbol as shown below. If the cursor does not protrude through the shaded sector in the symbol, the plane cursor and sector are not properly aligned.

3

6 1

2

3

Plane cursor in longitudinal scan plane symbol Plane cursor in transverse scan plane symbol Shaded sector

Incorrect

12

12 3

9

6

Correct positioning of plane cursor shown in the longitudinal (left) and transverse (right) plane symbol.

I N S T R U C T I O N S

3

9

6

[ 2 ]

3

9

The plane cursor for the longitudinal plane is fixed and cannot be moved. However, you can roll the trackball to reposition the shaded sector.

Correct

2

F O R

U S E

Incorrect positioning of plane cursor. The cursor must extend through the shaded sector.

C3 - 7

C3 Endo-P II Transducer

Transducer Markings and Indicators The Endo-P II transducer is designed with orientation markings on the handle of the transducer and depth markings along the shaft of the transducer.

Transducer Shaft The transducer shaft is marked in one-centimeter increments from 6 cm to 20 cm. These markings indicate the depth of the transducer upon insertion into the rectum. The markings also provide a reference for attaching accessories.

Transducer Insertion Depth Marks.

C3 - 8

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Transducer Handle The transducer handle contains the numbers 3, 6, 9, and 12. These numbers correspond to the numbers in the transverse scan plane symbol that displays on the image screen. Use these numbers as a reference when imaging with the transducer. By holding the transducer with the number 12 on top, you can orient the transducer with the scan plane symbol as shown in the following example.

12

3

9

The numbers shown in the transverse plane symbol indicate the relationship of the sector image to the handle on the transducer. This symbol displays in the image area. When you roll the trackball to change the location of the imaging sector, the position of the shaded sector in the symbol also changes in a corresponding manner.

6 Orientation Markings for Transverse Plane Symbol.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 9

C3 Endo-P II Transducer

Preparation for Use [1] Instructions for Use

WARNING: Ensure the transducer is properly cleaned and high-level disinfected before use to avoid possible patient contamination. WARNING: To avoid electrical shock to the patient, you must visually inspect the transducer prior to each use. Examine the entire transducer with particular attention to the transducer tip. Do not use the transducer if the transducer tip is cracked or shows signs of fluid leakage. Do not use a transducer which has a cracked, punctured, or discolored casing or a frayed cable.

Cleaning and Disinfecting Approved List of Disinfectants

Ch 2 Ch 2

Discoloration Exception: The use of Cidex OPA and Gigasept FF disinfectants may cause discoloration of transducer housings. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

Using a Protective Sheath WARNING: To reduce the risk of electrical shock, you must use the protective sheaths that are specified in the Endo-P II transducer kit number 10030776. You must refer to the in-box instructions for proper application of the protective sheath. WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and be prepared to treat allergic reactions promptly. For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1.

For patient and operator safety, you must cover the Endo-P II transducer with a protective sheath at all times during use. Refer to the in-box instructions for proper application of the protective sheath.

C3 - 10

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Connecting the Transducer Caution: When moving the system, disconnect the transducer and transport it separately in its protective carrying case. Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the transducer. Turn the lock counter-clockwise and grasp the connector by holding on to the connector housing. Note: Always freeze the system when connecting or disconnecting the Endo-P II transducer. The transducer should be in the transverse plane before it is disconnected from the system. Note: Always ensure that the Endo-P II transducer is in the transverse plane and the system is in freeze before activating another transducer, disconnecting the Endo-P II transducer, or powering off the system. Note: Place the transducer in the transducer holder on the system or in its protective carrying case when not in use.

Mechanical sector port.

To connect a mechanical sector transducer: 1. Hold the transducer connector with the cable pointing upwards. 2. Insert the connector pins into the system port and turn the lock on the transducer connector clockwise until it locks in position. This secures the connector in position and ensures the best possible contact. 3. Place the transducer in the transducer holder and drape the cable through the cable holder.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 11

C3 Endo-P II Transducer

Activating a Transducer Although multiple transducers can be connected to the ultrasound system, only one transducer can be active. Use the system presets to select the transducer port that will be active at system power-on.

System Reference System Presets

Ch 3

F6 Boot Up ► Transducer Port Active On Boot Up

To activate a transducer connected to the system: 1. Press the TRANSDUCER key located on the control panel. The name of the active transducer displays on the upper left of the screen. 2. To activate another transducer connected to the system, press the TRANSDUCER key again.

C3 - 12

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Imaging with the Endo-P II Transducer The Endo-P II transducer supports all of the functions and controls that are available in 2D-mode and M-mode. When you have acquired an image, you can change the orientation of the image, make measurements and calculations, annotate with pictograms or text, or perform a biopsy or puncture procedure.

Changing the Transmit Frequency Push the MULTIHERTZ control on the control panel up to increase the frequency or down to decrease the frequency. The system uses the next available frequency, 5.0 MHz, 6.0 MHz, or 7.5 MHz, for imaging. The system displays the name of the active transducer and operating frequency in the upper left of the image screen.

2D/M-Mode Display and Update For mechanical sector transducers, the system defaults to a periodically refreshed 2D-mode image with a real-time M-mode sweep. The 2D-mode image is frozen until the M-mode sweep is complete. The M-mode sweep then freezes while the 2D-mode image is refreshed, and then displays again in real time. Use the system presets to set the refresh rate for mechanical sector transducers.

System Reference System Presets

Ch 3

F6 Imaging ► Update Frames in 2D/M

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 13

C3 Endo-P II Transducer

Selecting the Sector Angle and Adjusting the FOV You can change the sector angle to select the field of view. The scan plane icon indicates the position of the field of view. Use the system presets to display the scan plane icon. To select the sector angle:

F6 Display ► Scan Plane Icon

1. Press the MENU key on the control panel when 2D-mode is active. 2. Roll the trackball to Scan Angle on the 2D-mode menu. The current angle setting displays next to the selection. The scan angle on the ultrasound system represents the imaging sector. The available angle selections are 80°, 110°, 160°, and 220°. 3. Select the scan angle by rotating the SELECT control on the control panel or cycle through the selections by pressing the SET key. 4. Place the imaging sector within the field of view for the active plane by rolling the trackball. 5. To rotate the sector and plane cursor in the longitudinal plane: a.

Press the SELECT control.

b. Roll the trackball to place the sector and plane cursor. c.

Press the SELECT control to release the plane cursor.

The active imaging sector is represented by a shaded sector in the graphical plane symbols that display onscreen.

12

3

9 6

When the transverse plane is active, a shaded sector is depicted in the transverse scan plane symbol.

When the longitudinal plane is active, the shaded sector is depicted in the longitudinal scan plane symbol.

The sector in these illustrations represents a 110° scan angle selection.

C3 - 14

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Changing the Image Orientation The following illustrations indicate how the displayed image is oriented when you use ROTATE. Each press of ROTATE rotates the image 90° clockwise.

90°

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

180°

270°

C3 - 15

C3 Endo-P II Transducer

Selecting a Scan Plane To make it easier to locate the area of interest, begin imaging in the transverse plane, then change to the longitudinal plane. To change from the transverse to the longitudinal plane: 1. Using the Endo-P II transducer in the transverse plane, acquire an image. SIEMENS 12

3

9 6

The shaded sector is in the transverse scan plane symbol when you are imaging in the transverse plane.

2. Roll the trackball until the area of interest displays on the image screen. SIEMENS 12

3

9 6

The scan plane symbol containing the shaded sector represents the active imaging sector. NOTE: When the 355° field of view is active, the trackball will not change the scan plane.

3. Press SET to place the in-line cursor on the image screen. SIEMENS 12

. . . . . . . .

C3 - 16

3

9 6

The in-line cursor indicates where the intersection of the longitudinal plane will occur.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

4. Roll the trackball to place the in-line cursor in the area of interest. SIEMENS 12

. . . . . . . .

3

9 6

The position of the in-line cursor is represented by the plane cursor in the transverse scan plane symbol. The plane cursor must protrude through the shaded sector in the icon.

5. Press SET to change to the longitudinal plane. The transducer changes from the transverse plane to the longitudinal plane and is indicated by the shaded sector in the longitudinal plane icon. SIEMENS 12

The in-line cursor indicates the intersection of the transverse plane. The plane cursor is in a fixed position when imaging in the longitudinal plane.

3

9

. . . . . . . .

6

6. To reposition the sector in the longitudinal plane, roll the trackball. SIEMENS 12

3

9

. . . . . . . .

The plane cursor in the longitudinal plane icon must protrude through the shaded sector in the symbol.

6

7. To return to the transverse plane, press SET. The image displays with the in-line cursor. To remove the in-line cursor, press ESCAPE. 8. Always ensure that the Endo-P II transducer is in the transverse plane and the system is in freeze before activating another transducer, disconnecting the Endo-P II transducer, or powering off the system.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 17

C3 Endo-P II Transducer

Measurements and Calculations Measurements are available for determination of volume and other calculations. The Stepwise Volume and Incremental Volume are exclusively for use with the Endo-P II transducer.

Biopsy or Puncture Procedures When you use a needle guide with the Endo-P II transducer, always begin imaging in the transverse plane. Since the needle guide is in a fixed position on the transducer, you cannot reposition the active image sector using the trackball. The active image sector during a biopsy or puncture procedure is at the 12 o'clock position of the transducer. To locate the region of interest, rotate the Endo-P II transducer. Ensure that the in-line cursor passes through the region of interest, and then switch to the longitudinal plane.

ABCDEFGHIJKLM 12 . . . . . . . . . . . . . 12 9 11 . . . . . . . . . . . . . 11 10 . . . . . . . . . . . . . 10 9 . . . . . . . . . . . . .9 8 .. .. .. .. .. .. .. .. .. .. .. .. .. 8 7 . . . . . . . . . . . . .7 6 . . . . . . . . . . . . .6 5 5 4 . . . . . . . . . . . . .4 3 . . . . . . . . . . . . .3 2 . . . . . . . . . . . . .2 1 . . . . . . . . . . . . .1 0 . . . . . . . . . . . . .0 ABCDEFGHIJKLM

[2] Instructions for Use Biopsy

Ch A4

12 3 6

Example of Tpl (template) guidelines available for use with the brachytherapy option.

C3 - 18

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

Endo-P II Transducer Accessories Refer to the in-box instructions for proper application of the protective sheath.

Endo-P II Needle Guide Kit The Endo-P II Needle Guide Bracket Kit consists of the bracket, syringe-adapter, and cleaning brush. The kit can be configured with three different needle guide sets: Endo-P II Needle Guide Sets

90 mm linear needle guide, qty 3

120 mm needle guide, qty 3

120 mm curved needle guide, qty 3

Preparation for Use WARNING: To reduce the risk of electrical shock, you must use the protective sheaths that are specified in the Endo-P II transducer kit number 10030776.

[1] Instructions for Use Cleaning and Care Sterilization

Ch 2 Ch 2

You must refer to the in-box instructions for proper application of the protective sheath. WARNING: Do not attempt to use the Needle Guide Bracket Kit until you have read the following instructions. The needle guide should only be used after proper training and after verifying the path of the needle. WARNING: The bracket and needle guide sets are packaged non-sterile. Sterilize these products prior to their first use. WARNING: Ensure the bracket and needle guide are properly cleaned and sterilized before each use to avoid possible patient contamination.

[2] Instructions for Use Biopsy Needle Path Verification

Ch A4 Ch A4

WARNING: There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Health care professionals are advised to identify latex-sensitive patients and to be prepared to treat allergic reactions promptly. In the USA, refer to FDA Medical Alert MDA91-1. Caution: Use only a water-soluble ultrasound coupling agent with this kit. Petroleum- or mineral oil-based materials can harm the transducer.

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 - 19

C3 Endo-P II Transducer

To attach the needle guide to the transducer: 1. Place the tranducer in the protective sheath specified in the Endo-P II transducer kit. You must refer to the in-box instructions for proper application of the protective sheath. 2. Loosen the knurled knob on the bracket completely.

Knob Needle Guide Bracket.

3. Position the bracket onto the Endo-P II transducer. The bracket should sit flat against the top level of the transducer.

Attaching the Bracket to the Transducer, Top View. Note: If using the 90 mm needle guide only, perform step 4. If using either of the 120 mm needle guides, skip step 4 and proceed to step 5.

4. For the 90 mm needle guide only, slide the bracket until the center is aligned with the 10 cm marking on the transducer. The edge of the bracket closest to the scan face of the transducer should align with the 9 cm marking on the transducer shaft. Now tighten the knurled knob of the bracket. Proceed to step 6.

Bracket Position for 90 mm Needle Guides, Top View.

5. Slide the bracket until the center is aligned with the 13 cm marking on the transducer. The edge of the bracket closest to the scan face of the transducer should align with the 12 cm marking on the transducer shaft. Now tighten the knurled knob of the bracket.

Bracket Position for 120 mm Needle Guides, Top View.

C3 - 20

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

C3 Endo-P II Transducer

6. Wet the covered transducer tip with a water-soluble coupling agent. 7. Pull a transducer sheath (not a protective sheath provided in the Endo-P II transducer kit) tightly over the transducer and bracket.

Covering the Transducer and Bracket.

8. Set the needle guide on the bracket.

Placing a Curved Needle Guide onto the Bracket.

9. Rotate the needle guide lock 90° to secure the needle guide to the bracket.

Securing the Needle Guide to the Bracket.

10. Insert the desired needle into the needle guide. The needle size should be a maximum of 18 gauge with a recommended length of at least 20 cm. 11. Before performing any patient procedure, verify the path of the needle.

[2] Instructions for Use Needle Path Verification

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

Ch A4

C3 - 21

C3 Endo-P II Transducer

Technical Data Mechanical Sector Endo-P II Transducer Transducer type:

Mechanical Sector (two rotating crystals)

Frequency range:

5.0, 6.0 and 7.5 MHz for B-mode

Focus:

5.0 MHz: 25 mm 7.5 MHz: 22 mm

Operating modes:

B, 2B, SPLIT B (B+B), 4B, M, B/M

Maximum displayable field of view:

Transverse plane: Longitudinal plane:

355° 240°

Sector angle:

80°, 110°, 160°, 240°, 355°

Scanning direction:

Right/left Bottom, 90°, 180°, 270° image rotation

Field size:

3 to 12 cm

Orientation:

An icon for the longitudinal plane and an icon for the transverse plane.

Operating environment:

+20°C to +40°C Up to an altitude of 3,000 m

Storage:

-5°C to +50°C Up to an altitude of 4,000 m

Humidity:

Up to 80% relative humidity at 40°C

C3 - 22

[ 2 ]

I N S T R U C T I O N S

F O R

U S E

SONOLINE G20 Ultrasound Imaging System System Reference

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

10031089-ABS-003-01

ii

S Y S T E M

R E F E R E N C E

SONOLINE G20 Ultrasound Imaging System System Reference 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.

S Y S T E M

R E F E R E N C E

iii

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.

iv

S Y S T E M

R E F E R E N C E

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

System Presets

Imaging Functions ChA1

Screen Saver Intended Use

Ch 1 Ch 1

[2] Instructions for Use

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.

S Y S T E M

R E F E R E N C E

System Reference Accessories and Options

Ch 2

F6 Default Settings ►Automatic Freeze Response

v

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

vi

S Y S T E M

R E F E R E N C E

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:

S Y S T E M

Highlight the Keyboard – Annotation option.

R E F E R E N C E

vii

Table of Contents System Reference Chapter Title

Chapter Description

Chapter 1

Acoustic output and MI/TI information.

Chapter 2

Listing of the available configurations of the ultrasound system.

Chapter 3

Instructions for using the options in the Preset Main Menu to customize the system.

Chapter 4

Explanation of the integrated workstation option, including storage and management of studies on the hard disk or CD.

Chapter 5

Information on documentation and storage devices, including procedures for storing and retrieving system presets and QuickSets.

Acoustic Output Reference Accessories and Options System Presets Patient Data Management Documentation Devices Chapter 6

DICOM Connectivity Option

Explanation of the Digital Imaging and Communications in Medicine (DICOM) Connectivity option. This option works in conjunction with the DIMAQ-IP integrated workstation to provide digital image transfer via a DICOM network for both storage and printing.

Chapter 7

A description of setting up and using the network export function. This function copies patient data to a password-protected shared folder on a destination device (export host) for offline-analysis.

Chapter 8

Guidelines for transmitting data from the ultrasound system through the serial ports to a personal computer (PC), printer, or other device.

Network Export Function

Data Transmission Guidelines Chapter 9

Listing of authors and reference tables implemented for the Obstetric exam.

Chapter 10

Listing of authors implemented for the Cardiac exam.

Obstetrical References Cardiac References Chapter 11

Brochure

Medical Ultrasound Safety, American Institute of Ultrasound in Medicine.

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.

viii

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference Transducer Technical Data and Acoustic Output............................................ 3 Display Resolution and Measurement Accuracy ........................................... 3 Default Displayed MI and TI Values by Transducer ....................................... 4 Transducers and Intended Applications......................................................... 5 IEC 61157 Acoustic Output Reporting .............................................................. 6 Track 3, FDA 510(k) Acoustic Output Reporting............................................ 11 Summary Table for Acoustic Output ........................................................... 11 Definitions ................................................................................................... 12

S Y S T E M

R E F E R E N C E

1 - 1

1 Acoustic Output Reference

1 - 2

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Transducer Technical Data and Acoustic Output The assessment of the biological effects of diagnostic ultrasound on humans is a subject of ongoing scientific research. This system, and all diagnostic ultrasound procedures, should be used for valid reasons, for the shortest possible period of time, and at the lowest mechanical and thermal indices necessary to produce clinically acceptable images. According to the ALARA (As Low As Reasonably Achievable) principles, acoustic output should be set to the lowest level required to satisfactorily perform the examination. The ultrasound imaging system complies with the standards of the American Institute of Ultrasound in Medicine (AIUM), the National Electrical Manufacturer's Association (NEMA), the guidelines of the United States Food and Drug Administration (FDA), and the guidelines of the International Electrotechnical Commission (IEC) in terms of safety and acoustic output levels. The ultrasound output levels are stated to permit the user to critically evaluate the system settings in the event of new research findings being announced. For systems distributed within the United States of America, the Medical Ultrasound Safety ultrasound education program brochure produced by the AIUM is included at the end of this manual. Refer to this brochure for information relating to the bioeffects and biophysics and prudent use of diagnostic ultrasound, and how to implement the principle of ALARA.

Display Resolution and Measurement Accuracy For any transducer capable of exceeding a mechanical or thermal index value of 1.0, the ultrasound imaging system displays indices starting from 0.4. The resolution of the display is 0.1 for all displayed values of MI. For all TI values, the resolution of the display is 0.2. It is important to note that displayed indices are obtained through measurement, and are subject to measurement errors. Specific measurement uncertainties for acoustic power, pressure, and center frequency are 4.2%, 9.4%, and 2.0% respectively. Measurement precision for ultrasonic power, peak rarefactional pressure, and center frequency from a standard test transducer/driver combination is 6.1%, 8.1%, and 0.2% respectively. The reported values assume 90% population (P ) at 90% confidence level ( γ ).Definitions for these parameters can be found in the 1998 AIUM/NEMA document entitled Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment – Revision 1 (also known as the Output Display Standard).

S Y S T E M

R E F E R E N C E

1 - 3

1 Acoustic Output Reference

Default Displayed MI and TI Values by Transducer (Per transducer/mode that exceeds default MI or TI value of 1.0) Mode B Transducer

MI

M TI

MI

TI

7.5L75S

----

----

----

----

L10-5

----

----

----

----

C4-2

----

1.2

----

----

C5-2

----

----

----

----

C8-5

----

1.0

----

----

EC9-4

----

----

----

----

EV9-4

----

----

----

----

Endo-P II

----

----

----

----

Endo-V II

----

----

----

----

1 - 4

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Transducers and Intended Applications Only the following transducers from Siemens are compatible with the SONOLINE G20 ultrasound imaging system: TRANSDUCER NAME

OPERATING FREQUENCY

MODES OF OPERATION

INTENDED APPLICATIONS

CURVED AND LINEAR ARRAY TRANSDUCERS C4-2

2 – 5 MHz

B, M

Abdomen, Renal, Cardiac

C5-2

2 – 5 MHz

B, M

Abdomen, Renal, Obstetrics, Gynecology

C8-5

5 – 8 MHz

B, M

Pediatric Abdomen, Neonatal Cephalic

EC9-4

4 – 9 MHz

B, M

Prostate, Early Obstetrics, Gynecology

EV9-4

4 – 8 MHz

B, M

Early Obstetrics, Gynecology

7.5L75S

5 – 10 MHz

B, M

L10-5

5 – 10 MHz

B, M

Breast, Thyroid, Orthopedics, Musculoskeletal Thyroid, Breast, Testis, Orthopedics, Musculoskeletal

Endo-V II

5.0 – 7.5 MHz

B, M

Early Obstetrics, Gynecology

Endo-P II

5.0 – 7.5 MHz

B, M

Endorectal, Prostate

MECHANICAL SECTOR TRANSDUCERS

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. Refer to the Electromagnetic Emissions and Immunity Guidence and Manufacturer’s Declaration.

S Y S T E M

R E F E R E N C E

1 - 5

1 Acoustic Output Reference

IEC 61157 Acoustic Output Reporting Acoustic output information for the SONOLINE G20 ultrasound imaging system. Linear Array Transducer. Type: 7.5L75S Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Bp

Bi

Mp

p_ (MPa)

Mode

2.9

2.9

2.9

Mi 2.9

I spta (mW/cm2)

170

200

230

260

System settings

6.0 MHz

6.0 MHz

6.0 MHz

6.0 MHz

Focus in mm

25

30

25

30

Output in dB

0

0

0

0

I p (mm)

22

25

22

25

W pb6 (II) (mm)

1.1

1.2

1.1

1.2

(⊥) (mm)

1.2

1.1

1.2

1.1

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

252

252

-

-

6.0 x 8.3

7.2 x 8.3

6.0 x 8.3

7.2 x 8.3

f awf (MHz)

6.1

6.1

6.1

6.1

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

42

47

3.6

4.0

I ob (mW/cm2)

85

79

7.3

6.7

Power-up mode

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Linear Array Transducer. Type: L10-5 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Bp

Bi

Mp

p_ (MPa)

Mode

3.3

3.0

3.3

Mi 3.0

I spta (mW/cm2)

190

260

170

210

System settings

7.5 MHz

6.5 MHz

7.5 MHz

6.5 MHz

Focus in mm

21

21

21

21

Output in dB

0

0

0

0

I p (mm)

17

17

17

17

W pb6 (II) (mm)

1.2

1.3

1.2

1.3

(⊥) (mm)

1.2

1.4

1.2

1.4

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

252

252

-

-

4.6 x 5.0

4.6 x 5.0

4.6 x 5.0

4.6 x 5.0

f awf (MHz)

6.8

6.3

6.8

6.3

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

33

53

2.8

4.5

I ob (mW/cm2)

140

230

12

20

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Power-up mode

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 6

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Convex Array Transducer. Type: C4-2 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Mode

Bp

Bi

Mp

Mi

p_ (MPa)

1.8

1.5

1.8

1.5

I spta (mW/cm2)

150

250

79

160

System settings

3.5 MHz

5.6(2.8) MHz

3.5 MHz

5.6(2.8) MHz

Focus in mm

120

102

120

102

Output in dB

0

0

0

0

I p (mm)

56

52

56

52

W pb6 (II) (mm)

6.7

5.6

6.7

5.6

(⊥) (mm)

1.9

1.9

1.9

1.9

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

250

250

-

-

12 x 14

11 x 14

12 x 14

11 x 14

f awf (MHz)

3.3

2.9

3.3

2.9

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

140

230

12

20

I ob (mW/cm2)

81

150

6.9

13

Power-up mode

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Convex Array Transducer. Type: C5-2 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Bp

Bi

Mp

p_ (MPa)

Mode

2.6

1.7

2.6

Mi 1.7

I spta (mW/cm2)

160

210

150

180

System settings

3.5 MHz

5.6(2.8) MHz

3.5 MHz

5.6(2.8) MHz

Focus in mm

73

61

73

61

Output in dB

0

0

0

0

I p (mm)

53

44

53

44

W pb6 (II) (mm)

2.9

3.0

2.9

3.0

(⊥) (mm)

2.9

4.2

2.9

4.2

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

252

252

-

-

15 x 12

11 x 12

15 x 12

11 x 12

f awf (MHz)

3.7

3.0

3.7

3.0

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

170

310

14

26

I ob (mW/cm2)

120

250

9.8

21

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Power-up mode

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

S Y S T E M

R E F E R E N C E

1 - 7

1 Acoustic Output Reference

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Convex Array Transducer. Type: C8-5 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Mode

Bp

Bi

Mp

Mi

p_ (MPa)

2.3

2.3

2.3

I spta (mW/cm2)

110

110

93

93

System settings

6.5 MHz

6.5 MHz

6.5 MHz

6.5 MHz

Focus in mm

27

27

27

27

Output in dB

0

0

0

0

I p (mm)

17

17

17

17

W pb6 (II) (mm)

1.6

1.6

1.6

1.6

(⊥) (mm)

1.0

1.0

1.0

1.0

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

250

250

-

-

4.0 x 5.0

4.0 x 5.0

4.0 x 5.0

4.0 x 5.0

f awf (MHz)

6.4

6.4

6.4

6.4

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

21

21

1.8

1.8

I ob (mW/cm2)

100

100

8.7

8.7

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Power-up mode

Inclusive modes a b

2.3

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Convex Array Transducer. Type: EC9-4 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Bp

Bi

Mp

p_ (MPa)

Mode

3.0

2.8

3.0

Mi 2.8

I spta (mW/cm2)

200

220

190

210

System settings

4.2 MHz

4.2 MHz

4.2 MHz

4.2 MHz

Focus in mm

21

26

21

26

Output in dB

0

0

0

0

I p (mm)

18

20

18

20

W pb6 (II) (mm)

1.8

2.0

1.8

2.0

(⊥) (mm)

2.1

1.7

2.1

1.7

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

252

252

-

-

5.3 x 5.0

5.7 x 5.0

5.3 x 5.0

5.7 x 5.0

f awf (MHz)

4.8

4.7

4.8

4.7

a

APF (%)

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

98

94

8.4

8.1

I ob (mW/cm2)

370

330

32

28

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Power-up mode

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 8

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Convex Array Transducer. Type: EV9-4 Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Bp

Bi

Mp

p_ (MPa)

Mode

2.9

2.7

2.9

Mi 2.7

I spta (mW/cm2)

120

170

140

220

System settings

6.5 MHz

4.2 MHz

6.5 MHz

4.2 MHz

Focus in mm

19

19

19

19

Output in dB

0

0

0

0

I p (mm)

18

17

18

17

W pb6 (II) (mm)

1.3

1.3

1.3

1.3

(⊥) (mm)

1.5

1.7

1.5

1.7

prr (kHz)

7.8

7.8

1.0

1.0

srr (Hz)

252

252

-

-

4.9 x 6.0

4.9 x 6.0

4.9 x 6.0

4.9 x 6.0

f awf (MHz)

5.8

5.5

5.8

5.5

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

39

68

3.3

5.8

I ob (mW/cm2)

130

230

11

20

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Power-up mode

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Mechanical Sector Transducer. Type: Endo-V II Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Mode

Bp

Bi

Mp

Mi

p_ (MPa)

1.4

1.4

1.4

I spta (mW/cm2)

10

10

25

25

System settings

5.0 MHz

5.0 MHz

5.0 MHz

5.0 MHz

Focus in mm

30

30

30

30

Output in dB

0

0

0

0

I p (mm)

25

25

25

25

W pb6 (II) (mm)

1.6

1.6

1.6

1.6

(⊥) (mm)

1.7

1.7

1.7

1.7

6.2

6.2

0.25

0.25

prr (kHz) srr (Hz)

1.4

17

17

-

-

8.0Φ

8.0Φ

8.0Φ

8.0Φ

f awf (MHz)

5.4

5.4

5.4

5.4

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

30

30

0.80

0.80

I ob (mW/cm2)

59

59

1.6

1.6

Power-up mode

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

S Y S T E M

R E F E R E N C E

1 - 9

1 Acoustic Output Reference

Acoustic output information for the SONOLINE G20 ultrasound imaging system. Mechanical Sector Transducer. Type: Endo-P II Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group Parameter

Mode

Bp

Bi

Mp

Mi

p_ (MPa)

1.4

1.3

1.4

I spta (mW/cm2)

8.2

8.8

21

22

System settings

5.0 MHz

7.5 MHz

5.0 MHz

7.5 MHz

Focus in mm

35

20

35

20

Output in dB

0

0

0

0

I p (mm)

24

19

24

19

W pb6 (II) (mm)

1.7

1.5

1.7

1.5

(⊥) (mm)

1.7

1.4

1.7

1.4

6.8

6.8

0.25

0.25

prr (kHz) srr (Hz)

1.3

17

17

-

-

7.0Φ

7.0Φ

7.0Φ

7.0Φ

f awf (MHz)

5.2

5.9

5.2

5.9

APF (%)

a

n/a

n/a

n/a

n/a

AIF (%)

b

n/a

n/a

n/a

n/a

Maximum power (mW)

29

22

0.71

0.55

I ob (mW/cm2)

76

58

1.9

1.4

Power-up mode

B

B

B

B

Initialization mode

n/a

n/a

n/a

n/a

Acoustic output freeze

Yes

Yes

Yes

Yes

I tt (mm)

n/a

n/a

n/a

n/a

I ts (mm)

contact

contact

contact

contact

-

-

B+M

B+M

Output beam dimensions (mm)

Inclusive modes a b

Acoustic power-up fraction Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 10

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Track 3, FDA 510(k) Acoustic Output Reporting Data presented in Track 3 format represents the average MI/TI values for five transducers measured under worst-case acoustic output conditions. The on-screen MI/TI values are based on measurements on one transducer under worst case acoutstic output conditions - rounded up to the nearest display increment. It is possible that the values displayed on screen may exceed the MI/TI values presented in the Track 3 format.

System Reference IEC 61157

1-6

Summary Table for Acoustic Output An "X" indicates that either the MI index or TI indices is greater than 1.0 for each transducer/mode. A Track 3 format acoustic output table is supplied for each transducer/mode combination marked with an "X". Operating Mode

Transducer Model

X

X X

M-mode

X

X

X X

Endo-V II

X

Endo-P II

C8-5

C4-2

EV9-4

EC9-4

C5-2

L10-5

75L75S B-mode (2D)

The following rules apply to the summary table: B-mode (2D)

No other mode active. Only MI (when larger than 1.0) is reported for this mode.

M-mode

Includes simultaneous B-mode.

PW-Doppler

In duplex modes, the largest displayed TIS (scanned or non-scanned) is reported if it is larger than 1.0.

Color Flow or Power

Includes simultaneous color flow M-mode, B-mode, and Doppler.

Other

The output is reported as a separate mode if the largest formulation of TIS, TIB, or TIC (if an intended use) is greater than the corresponding value reported for all constituent mode.

In combined modes, the largest displayed TIS (scanned or non-scanned) is reported if it is larger than 1.0.

TIC is reported if the transducer is intended for transcranial or neonatal cephalic use.

S Y S T E M

R E F E R E N C E

1 - 11

1 Acoustic Output Reference

Definitions Symbol

Definition

Units

MI

Mechanical Index

N/A

TIS Scan

Soft Tissue Thermal Index in autoscanning mode

N/A

TIS Non-scan

Soft Tissue Thermal Index in non-autoscanning mode

N/A

TIB

Bone Thermal Index

N/A

TIC

Cranial Thermal Index

N/A

Aaprt

Area of the active aperture

cm2

Pr.3

Derated peak rarefactional pressure

MPa

Wo

Ultrasonic power, except for TIS Scan, in which case it is the ultrasonic power passing through a one centimeter window.

mW

W.3(Z1)

Derated ultrasonic power at axial distance Z1

mW

ITA.3(Z1)

Derated spatial-peak, temporal-average intensity at axial distance Z1.

mW/cm2

Z1

Axial distance corresponding to the location of the max [W.3(Z1), ITA.3(Z) x 1 cm2)], where Z > Zbp.

cm2

Zbp

1.69 (Aaprt)1/2.

cm

Zsp

For MI: axial distance at which Pr.3 is measured For TIB: axial distance at which TIB is a maximum (i.e., Zsp = ZB.3)

cm

deq (Zsp)

Equivalent beam diameter as a function of axial distance, and is equal to where ITA (Z) is the temporal-average intensity as a function of Z

cm

fc

Center frequency

MHz

Dim. of Aaprt

Active aperture dimensions for the azimuth and elevational planes

cm

PD

Pulse duration

µs

PRF

Pulse repetition frequency

Hz

Pr @ PII max

Peak rarefactional pressure at the point where the free-field, spatial-peak pulse intensity integral is a maximum

MPa

d eq@ PII max

Equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity integral is a maximum

cm

FL

Focal Length, or azimuthal and elevational lengths, if different

cm

I pa.3 @ MI max

Derated pulse-average intensity at the point of global maximum

W/cm2

1 - 12

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

L10-5

Transducer model:

Operating mode: B-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

Maximum Value

---

1.0

Pr.3

(MPa)

2.5

TIB Non-scan

Aaprt ≤1

Aaprt >1

(a)

(a)

(a)

#

#

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

fc

(MHz)

Dim. of Aaprt

TIC

Non-scan (a)

(a)

#

#

# 1.3

# #

6.4

#

#

#

#

#

X (cm)

#

#

#

#

#

Y (cm)

#

#

#

#

#

#

#

#

#

#

#

#

#

Other information PD

(µsec)

0.26

PRF

(Hz)

7800 2.9

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

#

FLy (cm) I pa.3 @ MI max

(W/cm2)

#

360

Operator Control TX-Level

(dB)

0

Focus (mm)

18

PRF (Hz)

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

L10-5

Transducer model:

Operating mode: M-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

TIB Non-scan

Aaprt ≤1

Aaprt >1

0.49

0.06

---

17

1.7

Maximum Value

---

1.0

Pr.3

(MPa)

2.5

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

TIC

Non-scan 0.13

0.38

1.9

17

# 1.3

1.4 0.18

fc

(MHz)

6.2

7.0

#

6.2

6.2

Dim. of Aaprt

X (cm)

1.6

1.6

#

1.6

1.6

Y (cm)

0.50

0.50

#

0.50

0.50

0.17

0.50

6.4

Other information PD

(µsec)

0.26

PRF

(Hz)

1000 2.9

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

8.3

8.3

#

8.3

FLy (cm)

2.0

2.0

#

2.0

I pa.3 @ MI max

(W/cm2)

360

Operator Control TX-Level

(dB)

Focus (mm)

0

0

0

0

0

18

83

83

83

83

PRF (Hz) a b c #

This Index is not relevant to this operating mode. This transducer is not intended for transcranial or neonatal cephalic uses. This formulation for TIS is less than that for an alternate formulation in this mode. No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

S Y S T E M

R E F E R E N C E

1 - 13

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model:

EC9-4

Operating mode: B-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

Maximum Value

---

1.0

Pr.3

(MPa)

2.3

TIB Non-scan

Aaprt ≤1

Aaprt >1

(a)

(a)

(a)

#

#

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

fc

(MHz)

Dim. of Aaprt

TIC

Non-scan (a)

(a)

#

#

# 1.8

# #

4.8

#

#

#

#

#

X (cm)

#

#

#

#

#

Y (cm)

#

#

#

#

#

#

#

#

#

#

#

#

#

Other information PD

(µsec)

0.28

PRF

(Hz)

7800 3.0

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

#

FLy (cm) I pa.3 @ MI max

(W/cm2)

#

370

Operator Control TX-Level

(dB)

0

Focus (mm)

21

PRF (Hz)

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model:

EC9-4

Operating mode: M-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

TIB Non-scan

Aaprt ≤1

Aaprt >1

0.34

0.03

---

10

1.3

Maximum Value

---

1.0

Pr.3

(MPa)

2.3

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

TIC

Non-scan 0.12

0.19

1.2

12

# 1.8

2.0 0.12

fc

(MHz)

4.6

5.0

#

4.6

4.6

Dim. of Aaprt

X (cm)

1.0

1.0

#

1.0

1.0

Y (cm)

0.50

0.50

#

0.50

0.50

0.13

0.45

4.8

Other information PD

(µsec)

0.28

PRF

(Hz)

1000 3.0

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

5.3

10

#

5.3

FLy (cm)

2.2

2.2

#

2.2

I pa.3 @ MI max

(W/cm2)

370

Operator Control TX-Level

(dB)

Focus (mm)

0

0

0

0

0

21

53

102

53

53

PRF (Hz) a b c #

This Index is not relevant to this operating mode. This transducer is not intended for transcranial or neonatal cephalic uses. This formulation for TIS is less than that for an alternate formulation in this mode. No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

1 - 14

S Y S T E M

R E F E R E N C E

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

C4-2

Transducer model:

Operating mode: B-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

Maximum Value

---

0.57

Pr.3

(MPa)

1.1

TIB Non-scan

Aaprt ≤1

Aaprt >1

(a)

(a)

(a)

#

#

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

fc

(MHz)

Dim. of Aaprt

TIC

Non-scan (a)

(a)

#

#

# 5.2

# #

3.4

#

#

#

#

#

X (cm)

#

#

#

#

#

Y (cm)

#

#

#

#

#

#

#

#

#

#

#

#

#

Other information PD

(µsec)

0.21

PRF

(Hz)

7800 1.7

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

#

FLy (cm) I pa.3 @ MI max

(W/cm2)

#

160

Operator Control TX-Level

(dB)

0

Focus (mm)

102

PRF (Hz)

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

C4-2

Transducer model:

Operating mode: M-mode

Associated Acoustic Parameters MI Index Label

TIS Scan

TIB Non-scan

Aaprt ≤1

Aaprt >1

1.5

---

0.11

110

#

Maximum Value

---

0.57

Pr.3

(MPa)

1.1

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

4.0 2.3

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

TIC

Non-scan 0.28

1.6

8.7

110

2.3 5.2

4.9 0.26

fc

(MHz)

2.8

#

2.8

3.0

2.8

Dim. of Aaprt

X (cm)

1.3

#

1.3

1.0

1.3

Y (cm)

1.4

#

1.4

1.4

1.4

0.27

1.2

3.4

Other information PD

(µsec)

0.21

PRF

(Hz)

1000 1.7

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

14

#

14

14

FLy (cm)

6.0

#

6.0

6.0

I pa.3 @ MI max

(W/cm2)

160

Operator Control TX-Level

(dB)

Focus (mm)

0

0

0

0

0

102

141

141

86

141

PRF (Hz) a b c #

This Index is not relevant to this operating mode. This transducer is not intended for transcranial or neonatal cephalic uses. This formulation for TIS is less than that for an alternate formulation in this mode. No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

S Y S T E M

R E F E R E N C E

1 - 15

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

C8-5

Transducer model:

Operating mode: B-mode

Associated Acoustic Parameters MI

TIS

Index Label

Scan

Maximum Value

---

0.70

Pr.3

(MPa)

1.8

TIB Non-scan

Aaprt ≤1

Aaprt >1

(a)

(a)

(a)

#

#

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

fc

(MHz)

Dim. of Aaprt

TIC

Non-scan (a)

(a)

#

#

# 1.4

# #

6.4

#

#

#

#

#

X (cm)

#

#

#

#

#

Y (cm)

#

#

#

#

#

#

#

#

#

#

#

#

#

Other information PD

(µsec)

0.14

PRF

(Hz)

7800 2.0

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

#

FLy (cm) I pa.3 @ MI max

(W/cm2)

#

380

Operator Control TX-Level

(dB)

0

Focus (mm)

27

PRF (Hz)

Acoustic Output Reporting Table – Track 3, FDA 510(k) (Per transducer/mode that exceeds MI or TI value of 1.0)

C8-5

Transducer model:

Operating mode: M-mode

Associated Acoustic Parameters MI

TIS

Index Label

Scan

TIB Non-scan

Aaprt ≤1

Aaprt >1

1.3

0.09

---

25

2.9

Maximum Value

---

0.70

Pr.3

(MPa)

1.8

Wo

(mW)

min of [W.3(Z1), ITA.3(Z1)]

(mW)

# #

Z1

(cm)

Zbp

(cm)

Zsp

(cm)

deq (Zsp)

(cm)

TIC

Non-scan 0.11

0.74

2.1

25

# 1.4

1.5 0.24

fc

(MHz)

6.5

6.5

#

5.7

6.5

Dim. of Aaprt

X (cm)

0.88

0.88

#

0.88

0.88

Y (cm)

0.50

0.50

#

0.50

0.50

0.24

0.92

6.4

Other information PD

(µsec)

0.14

PRF

(Hz)

1000 2.0

Pr @ PII max

(MPa)

d eq@ PII max

(cm)

Focal Length

FLx (cm)

7.8

7.8

#

7.8

FLy (cm)

1.9

1.9

#

1.9

I pa.3 @ MI max

(W/cm2)

380

Operator Control TX-Level

(dB)

Focus (mm)

0

0

0

0

27

78

78

78

PRF (Hz) a b c #

This Index is not relevant to this operating mode. This transducer is not intended for transcranial or neonatal cephalic uses. This formulation for TIS is less than that for an alternate formulation in this mode. No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

1 - 16

S Y S T E M

R E F E R E N C E

2 Accessories and Options Accessories and Options ................................................................................... 3 SONOLINE G20............................................................................................. 4 Language-Specific Operating System .................................................... 4 Options.......................................................................................................... 4 Transducers, Linear Array.............................................................................. 5 Transducers, Curved Array ............................................................................ 5 Transducer Accessories ................................................................................ 5 PAL Documentation Devices......................................................................... 6 NTSC Documentation Devices ...................................................................... 6 Consumables................................................................................................. 6 Control Panel Overlays .................................................................................. 7 English.................................................................................................... 7 German .................................................................................................. 8 French .................................................................................................... 8 Spanish................................................................................................... 9 Italian...................................................................................................... 9

S Y S T E M

R E F E R E N C E

2- 1

2 Accessories and Options

2 - 2

S Y S T E M

R E F E R E N C E

2 Accessories and Options

Accessories and Options 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 availaibility of features and options.

The only Siemens-authorized accessories and options for the SONOLINE G20 ultrasound imaging system are described in this chapter. WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards (e.g., 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 standard EN 60601-1-1 and IEC 60601-1-1. Anyone who connects additional equipment to 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 standard EN 60601-1-1 and IEC 60601-1-1. Siemens can only guarantee the performance and safety of the devices listed in the Accessories and Options chapter. If in doubt, consult Siemens service department or your local Siemens representative. Note: To ensure compliance with the Medical Device Directive, use only the devices listed in this chapter with your ultrasound imaging system.

S Y S T E M

R E F E R E N C E

2 - 3

2 Accessories and Options

SONOLINE G20 Includes system software (CD), preset data disk (CD), transducer cups, power cord(s).

System Configurations Two standard array transducer ports1 Two standard array transducer ports and one mechanical sector transducer port2 Two standard array transducer ports and one parking port for linear and curved array transducers

Language-Specific Operating System Includes an overlay for the control panel and system user and reference manuals. English Language Operating System German Language Operating System French Language Operating System Spanish Language Operating System Italian Language Operating System

Options THI™ Tissue Harmonic Imaging Option TGO™ Tissue Grayscale Optimization Option DICOM 3.0 Connectivity Option DICOM Modality Worklist Option (requires the DICOM Connectivity Option) DICOM MPPS Option2 (requires the DICOM Connectivity Option and DICOM Modality Worklist Option) Dual-pedal footswitch Monitor filter Clip Store2 Brachytherapy Template Software2 (requires systems configured with a mechanical sector transducer port and the use of the Endo-P II transducer)

1 2

No longer available for purchase Requires software version 2.0 or higher

2 - 4

S Y S T E M

R E F E R E N C E

2 Accessories and Options

Transducers, Linear Array L10-5 7.5L75S

Transducers, Curved Array C4-21 C5-2 C8-51 EV9-4 EC9-4

Transducers, Mechanical Sector Endo-P II1 Endo-V II1

Transducer Accessories Transducer Sheaths: –

Non-sterile, EC9-4, Endo-V II1

–

Sterile, EV9-4, EC9-4, Endo-V II1

Biopsy Protective Sleeves, C5-2, L10-5, 7.5L75S, C4-21, C8-51 Standoff Gel Pad, Disposable, L10-5, 7.5L75S Universal Needle Guide Kit, Stainless Steel, C5-2, L10-5, C4-21, C8-51 Needle Guide Bracket Kit, 7.5L75S –

Needle Guide, 20G/0.9mm, 7.5L75S

–

Needle Guide, 18G/1.3mm, 7.5L75S

–

Needle Guide, 15G/1.8mm, 7.5L75S

–

Needle Guide, 2.3mm, 7.5L75S

–

Needle Guide, 2.5mm, 7.5L75S

Needle Guide Bracket Kit, Disposable, EC9-4 Needle Guide Bracket Kit, Stainless Steel, EC9-4 Needle Guide Bracket Kit, EV9-4 Needle Guide Bracket Kit, Endo-V II1 –

Needle Guide, 18G/1.2mm, Endo-V II

–

Needle Guide, 16G/1.6mm, Endo-V II

Needle Guide Bracket Kit, Endo-P II1

1

–

Needle Guide, 90, Endo-P II

–

Needle Guide, 120, Endo-P II

–

Needle Guide, C120, Endo-P II

Requires software version 2.0 or higher

S Y S T E M

R E F E R E N C E

2 - 5

2 Accessories and Options

PAL Documentation Devices B&W Video Printer, P93-W, Mitsubishi VCR, S-VHS, HS-MD3000, PAL, Mitsubishi

NTSC Documentation Devices B&W Video Printer, P93-W, Mitsubishi VCR, S-VHS, HS-MD3000, NTSC, Mitsubishi

Consumables Contact Scan Gel, 5 liter Contact Scan Gel, 0.25 liter Contact Scan Gel, Sterile Packets Paper, Black and White Video Printer Cleaning Sheets, Black and White Video Printer CD-R (10)

2 - 6

S Y S T E M

R E F E R E N C E

2 Accessories and Options

Control Panel Overlays The control panel on the ultrasound imaging system has overlays available in English, German, French, Spanish, and Italian.

English

S Y S T E M

R E F E R E N C E

2 - 7

2 Accessories and Options

German

French

2 - 8

S Y S T E M

R E F E R E N C E

2 Accessories and Options

Spanish

Italian

S Y S T E M

R E F E R E N C E

2 - 9

2 Accessories and Options

2 - 10

S Y S T E M

R E F E R E N C E

3 System Presets Setting General Preferences ............................................................................. 3 Using the System Presets............................................................................. 3 Navigating the Menu .............................................................................. 3 Making Screen Selections ...................................................................... 5 Preset Main Menu......................................................................................... 6 General – System Configuration Selections................................................... 8 Day/Time – System Configuration Selections................................................ 9 Patient ID – System Configuration Selections ............................................... 9 Imaging – System Configuration Selections ................................................ 10 Peripheral – System Configuration Selections ............................................. 11 Customize Keys – System Configuration Selections ................................... 12 Boot Up – System Configuration Selections................................................ 13 Storage – System Configuration Selections................................................. 13 Display – System Configuration Selections ................................................. 14 ReadySet – System Configuration Selections.............................................. 15 Default Settings – Exam Configuration Selections ...................................... 18 Selecting Pictograms............................................................................ 19 Selecting Text Annotation .................................................................... 21 QuickSet Parameters – Exam Configuration Selections .............................. 23 User-Defined Exam List – Exam Configuration Selections .......................... 23 M & R – Measurement & Report Configuration Selections ......................... 24 General Caliper Settings....................................................................... 24 Measurement and Report Preset Settings........................................... 25 Installation From Key Disk – Options Selections ......................................... 32 Clip Capture................................................................................................. 32 DIMAQ Utility – Options Selections ............................................................ 33 DICOM – Options Selections....................................................................... 34 Networking – Options Selections ................................................................ 34 Preset/QuickSet – Serviceability Selections................................................. 34 Service – Serviceability Selections............................................................... 34 System/Language – Serviceability Selections.............................................. 34

S Y S T E M

R E F E R E N C E

3 - 1

3 System Presets

Customizing OB and Early OB Measurements, Calculations, and Reports....................................................................................................... 35 Item & Reference Selection, Standard OB .................................................. 36 2D/M-Mode and Ratio Tabs ................................................................. 36 EFW/USMA Tab ................................................................................... 38 Item & Reference Selection, Early OB......................................................... 39 Display Configuration, Standard OB/Early OB ............................................. 39 Customize Growth Analysis Graphs, OB and Early OB ............................... 40 Standard OB/Early OB User-Defined Formulas ........................................... 41 Standard OB/Early OB User-Defined Tables................................................ 44 User-Defined Label, OB and Early OB ......................................................... 46 Customizing Cardiac Measurements, Calculations, and Reports ................ 47 Measurement Order – Cardiac .................................................................... 47 Customizing Emergency Medicine, Calculations, and Reports ................... 49

3 - 2

S Y S T E M

R E F E R E N C E

3 System Presets

Setting General Preferences When the ultrasound system is installed at your site, all system settings are factory-defined. You can use the options and settings available in the system presets to set up the ultrasound system with your preferences for imaging. System presets define the configuration of the system software whenever you power on the system.

System Reference CD Disk Drive

Ch 4

[2] Instructions for Use QuickSets

Ch A1

Using the System Presets You can use the system presets at any time to change the factory (default) settings or modify your own presets and QuickSets. It is advisable to back up your system presets and QuickSets on a CD to prevent accidental loss of your information. Presets saved on a disk also expedite the installation of a new system software release. To access the system presets: Press the F6 key on the keyboard. The system displays the Preset Main Menu screen with the most recently activated menu item selected. If no menu item has been activated since the system powered on, the system automatically selects (highlights) the General menu item on the left of the screen and displays its selections and options on the right of the screen.

Navigating the Menu The system organizes the system presets by menu items, selections, and options. You cannot select the heading for menu items (for example, System Configuration). You can select an indented menu item listed below the heading (for example, General).

S Y S T E M

R E F E R E N C E

3 - 3

3 System Presets

To use the Preset Main Menu: 1. After accessing the menu, roll the trackball up and down the left side of the screen to highlight a menu item. 2. Activate a highlighted menu item by pressing the SET key. The system displays either a new set of selections and options on the right of the Preset Main Menu screen or a full new screen.

Menu items marked with this symbol display a new screen.

3. Roll the trackball to an option or selection and then press the SET key. To exit the Preset Main Menu: Save your changes by selecting the Save button on the screen. The system saves any new options and selections and returns to imaging. Discard your changes by selecting the Cancel button on the screen or by pressing the ESCAPE on the control panel or F6 key on the keyboard. The system displays a dialog box if changes were made. –

To discard your changes and redisplay the image screen, select the OK button.

–

To retain your changes and stay in the current screen, select the Cancel button.

3 - 4

S Y S T E M

R E F E R E N C E

3 System Presets

Making Screen Selections Use the following techniques to make selections from the right side of the Preset Main Menu or in a newly-accessed screen. You can typically roll the trackball to position the trackball pointer on a menu item or setting and then press the SET key to complete the selection. Drop-down menus – To open the menu, roll the trackball to position the pointer on the arrow and then press the SET key. To make a selection, roll the trackball to highlight the selection and then press the SET key. Spin buttons – To set a higher or lower numeric value, roll the trackball to position the pointer on the up or down arrow and press the SET key until the desired value displays. Check boxes – The option is selected when a checkmark displays inside the box and de-selected when the box is clear. To select or clear the check box, roll the trackball to position the pointer in the box and then press the SET key. Buttons – To select a labeled button, roll the trackball to position the pointer on the button or the label and then press the SET key. In some places, only one button can be selected at a time. Text entry – Roll the trackball to position the cursor in the field and then press the SET key. Use the keyboard to enter text. When finished, use the TAB key to move to another field or roll the trackball to reposition the cursor and then press the SET key.

S Y S T E M

R E F E R E N C E

Drop-down menu.

Spin button.

Check box.

Option button. Text entry.

3 - 5

3 System Presets

Preset Main Menu The left side of the Preset Main Menu screen lists the following menu items: Menu Item

Allows you to...

System Configuration General

Enter the hospital name, designate format for date/time, height, and weight, and define other system settings.

Day / Time

Set the date and time, select the time zone, and specify a time server, if used.

Patient ID

Define settings for patient information.

Imaging

Designate maximum image brightness and video invert.

Peripheral

Assign connection for the RS-232C (Serial) port. Enable printing through the USB port. Designate the video source, format and impedance and the hard copy video polarity.

Customize Keys

Assign functions for the PRINT/STORE, DIGITAL STORE 1, and DIGITAL STORE 2 keys and the optional footswitch Pedal 2. Specify rotation direction for the DEPTH/ZOOM control.

Boot Up

Select a transducer port to be active at boot up. Select an exam type or QuickSet to activate automatically at system boot up.

Storage

Designate the image and patient report storage destination. Specify whether measurement data is stored with the image.

Display

Activate the on-screen status display, DGC curve, time markers, and icons. Control the screen saver, playback code, and character brightness. Set monitor contrast and flicker control.

ReadySet

nn

MUP1

1

Access a new screen. Establish onscreen icons that provide shortcuts to other screens and imaging and documentation functions. The ReadySet list is available for all exam types. Activate a password dialog box for use with the MODULARIS Uro Plus system.

Requires software version 2.0 or higher

3 - 6

S Y S T E M

R E F E R E N C E

3 System Presets

Menu Item

Allows you to...

Exam Configuration Default Settings

nn

Access a new screen. Designate display features and freeze response. Select pictograms and text labels for each exam type.

QuickSet Parameters

nn

Access a new screen if QuickSets have been defined. Edit certain parameters for QuickSets.

User-Defined Exam List nn

Access a new screen. Enable or disable access to each exam type.

M & R Configuration M&R

Select caliper (measurement function) conventions and establish measurement and report presets for each type of exam. Specify a default measurement menu category of measurement methods or labels.

Options Installation From Key Disk

List installed option information, Install, Uninstall, or Update an option installed with a key disk.

Clip Capture1

Designate clip capture parameters, such as capture length and compression.

DIMAQ Utility DICOM

nn nn

Networking

Activate password-protection of patient data. Install printers. Configure DICOM devices. Configure the network export function.

Serviceability Preset/QuickSet Utility

nn

Access a new screen. Select data for backup to CD and specify the write speed for the CD-R/RW drive.

Service

nn

Access a new screen. Access password-protected service procedures.

System / Language

1

Upgrade the system software or change the operating language.

Requires software version 2.0 or higher

S Y S T E M

R E F E R E N C E

3 - 7

3 System Presets

General – System Configuration Selections The General item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

Hospital Name

Text entry

Enter the name of your hospital or clinic using up to 60 characters. The first 20 characters display in a report. You can modify this entry at any time.

Date Format

Month/Day/Year Day/Month/Year Year/Month/Day

Select the format for the date. The date displays on the image screen, in the Patient Data form, and on patient reports.

Height and Weight Format

Feet/Pounds Centimeters/Kilograms

Select the format for the display of the patient's height and weight used in the Patient Data entry form.

Beep

On Off

Select this check box to enable the beep to sound when a key is pressed.

Beep Volume

1 through 9

Set the volume of the beep. Option 1 is the quietest, Option 9 is the loudest. The Beep check box must be selected for the Beep Volume to be effective.

DGC Invert with Image Invert

On Off

Select this check box to invert the DGC graphic on the image screen along with the image when you rotate the image.

Tx Power Display Format

dB %

Determine the format of the transmit power display on the image screen. dB displays the transmit power in decibels. % displays the transmit power as a percentage.

Trackball Travel/Speed

Low Medium High

Select the responsiveness of the system to trackball movement. Low repositions an object a short distance with minimal trackball movement. Medium repositions an object a moderate distance with minimal trackball movement. High repositions an object a long distance with minimal trackball movement.

Text Character Size

8 through 18

Arrow Size

8 through 18

Select the size of an arrow entered on the screen.

Delete Text on Unfreeze

On Off

Select this check box to erase on-screen text annotation after an image is unfrozen.

Default Annotation Type

Anatomy Position

Select the type of text displayed when you press the TEXT key.

Select the size of the font for displaying text annotation.

Anatomy displays anatomy annotations. Position displays body position annotations. Delete Pictogram on Unfreeze

On Off

Select this check box to erase an on-screen pictogram after an image is unfrozen.

Confirmation Power SW Dialog

On Off

Select this check box to display a confirmation dialog box when the system is powered off.

3 - 8

S Y S T E M

R E F E R E N C E

3 System Presets

Day/Time – System Configuration Selections The Day/Time item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

Date

Month _ _ Day _ _ Year _ _ _ _

Enter the current date.

Time

Hour _ _ Minute _ _ Second _ _

Enter the current time. The time displays on the Image screen.

Daylight Saving Time Adjustment (+1 Hour)

On Off

Quickly adjust the system clock to compensate for Daylight Saving Time. When this check box is selected, the system adds one hour to the clock.

Time Zone

Settings relative to GMT

Select the time zone relative to Greenwich Mean Time (GMT).

Time Server

Text entry

Enter the server that provides the time.

Use Time Server

On Off

Select this check box to user the time server.

Patient ID – System Configuration Selections The Patient ID item on the Preset Main Menu provides the following selections:

1

Selection

Option(s)

Allows you to...

Hide Patient Demographic

On Off

Display or hide the patient demographics, such as the patient name and patient identification on the image screen.

AutoStore New Patient Form1

On Off

Automatically store a screen representation of the completed patient data form to the registered patient's study.

Requires software version 2.0 or higher

S Y S T E M

R E F E R E N C E

3 - 9

3 System Presets

Imaging – System Configuration Selections The Imaging item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

Max Brightness (BW)

180 – 255

Select a brightness level for the image display. A higher number designates a brighter image.

Video Invert

Positive Negative

Select the polarity of the video display for the main image screen. Text is always white against black or black against white. Positive displays a white image area against a black background. Negative displays a black image area against a white background.

Update Frames in 2D/M1

1

1 sec 2 sec 3 sec

Select the number of frames of 2D-mode images to be acquired during the image refresh at the end of the M-mode sweep for mechanical sector transducers.

Requires software version 2.0 or higher

3 - 10

S Y S T E M

R E F E R E N C E

3 System Presets

Peripheral – System Configuration Selections The Peripheral item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

External RS-232C Port

Off Laser Printer PC2 Card Reader

Assign functionality to the serial port on the input/output panel of the ultrasound system. Off disables the RS-232C Serial port. Laser Printer sends report data, including graphics such as growth graphs, to a laser printer, using the HP PCL 3 protocol. PC2 sends OB report data to a PC. Card Reader reads the patient name and ID into the Patient Data form.

USB Printer

On Off

Enable Patient Report printing through the USB port. Select an available printer from a list.

Video Format

NTSC PAL

Select the video format for output to the onboard printer.

Video Input Source

Composite S-VHS

Select the input source for the VCR.

Video Input Impedance

75 [ohm] Hi-Z

Select the input impedance. Select 75 for inputs to the system monitor only. Select Hi-Z for inputs routed to other devices.

Hard Copy Video Polarity (Image)

Positive Negative

Select the polarity of the video output for an image. Positive displays a white image against a black background. Negative displays a black image against a white background.

Hard Copy Video Polarity (Report)

Positive Negative

Select the polarity of the video output for a report. Positive displays a white report against a black background. Negative displays a black report against a white background.

S Y S T E M

R E F E R E N C E

3 - 11

3 System Presets

Customize Keys – System Configuration Selections The Customize Keys item on the Preset Main Menu provides the following selections: Note: The MUP option is available for use only with the MODULARIS Uro Pro system.

1

[1] Instructions for Use Configuring Documentation Controls

Selection

Option(s)

Allows you to...

PRINT STORE key

B/W Print Disk Store DICOM B/W Printer D. Store & B/W Pr. MUP

Assign functionality to the PRINT STORE key.

DIGITAL STORE 1 key

B/W Print Disk Store DICOM B/W Printer D. Store & B/W Pr. TGO Clip Capture1 MUP

Assign functionality to the DIGITAL STORE 1 key.

DIGITAL STORE 2 key

B/W Print Disk Store DICOM B/W Printer D. Store & B/W Pr. TGO Clip Capture1 MUP

Assign functionality to the DIGITAL STORE 2 key.

Pedal 2 function

B/W Print Disk Store Clip Capture1

Assign foot pedal 2 functionality to the optional footswitch.

Zoom/Depth Direction

Clockwise Counterclockwise

Select which direction increases zoom depth.

Ch 4

Requires software version 2.0 or higher

3 - 12

S Y S T E M

R E F E R E N C E

3 System Presets

Boot Up – System Configuration Selections The Boot Up item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

Transducer Port Active on Boot Up

LC2 LC1 S11

Select the transducer port to be active when you power on the system.

Boot Up Exam & QuickSet

Note: Option S1 requires a mechanical sector port.

The Boot Up Exam & QuickSet List screen appears. Select a specific exam type or QuickSet to be active when you power on the system.

Storage – System Configuration Selections The Storage item on the Preset Main Menu provides the following selections:

1

Selection

Option(s)

Allows you to...

Image with Caliper

Yes No

Select whether to store caliper (measurement) information with the image.

Autostore to Network

On Off

Automatically save the current study to the network when the study (examination) is ended.

Autostore to DICOM

On Off

Automatically transfer the contents of the DICOM Store Queue to the DICOM storage server when the study (examination) is ended.

Requires software version 2.0 or higher

S Y S T E M

R E F E R E N C E

3 - 13

3 System Presets

Display – System Configuration Selections The Display item on the Preset Main Menu provides the following selections: Selection

Option(s)

Allows you to...

System Status Display

On Off

Display the parameters in the Image Parameter area at the bottom of the image screen.

Screen Saver

On Off

Activate or deactivate the screen saver.

Screen Saver Type

Black SONOLINE

Select either a black background or a SONOLINE logo background.

Screen Saver Time

5min. 10min. 15min. 20min.

Select the time delay before the system activates the screen saver.

DGC Curve Display

Off Always On Time Out

Select when the DGC graphic displays on the image screen. Off prevents the DGC from displaying on the image screen. Always On displays the DGC continuously on the image screen. Time Out removes the DGC from the screen three seconds after you adjust the curve. When you adjust the DGC controls again, the curve reappears on-screen.

Time Marker Display

On Off

Display a time marker on the image screen.

Scan Plane Icon1

On Off

Display a scan plane symbol on the image screen when a mechanical sector endocavity transducer is active.

Playback Code

On Off

Select when the encoded image displays on the screen. The encoded image information is used to make measurements on the images displayed from a video tape. Off prevents the encoded image information from displaying on the image screen. On displays the encoded imaging information continuously on the image screen.

1

Character Brightness

1, 2, 3, 4, 5, 6, 7

Select display character brightness.

Flicker Control

On Off

Select to improve the display of on-screen elements, images, and reports on an external monitor connected to the analog video output port on the ultrasound system.

Monitor Contrast

Low High

Select the amount of contrast for the monitor.

Requires software 2.0 or higher

3 - 14

S Y S T E M

R E F E R E N C E

3 System Presets

ReadySet – System Configuration Selections Use this selection to establish shortcuts to other screens and imaging and documentation functions. The shortcuts display as icons at the right side of the imaging screen. The ReadySet list is available for all exam types. Selection

Icon

Description

Arrow

Displays an arrow on the image that you can position using the trackball and orient using the SELECT control.

Biopsy

Activates the Biopsy function.

Modify

Provides a shortcut for modifying a measurement that has just been completed.

Current Patient

Displays the (current) Patient Data form.

Print Store

Prints to the output device selected in the system presets.

Angle (FOV)

Assigns the trackball to adjust the Field of View.

Hide Text

Toggles the display of on-screen text on and off.

L/R Flip

Changes the scan direction of a transducer.

New Patient

Displays a (new) Patient Data form.

Pictogram

Displays pictograms for the current exam.

Digital Store 1

Transfers exam data to the device selected in the system presets.

Digital Store 2

Transfers exam data to the device selected in the system presets.

Report

Displays the Patient Report.

Review

Activates review of stored exam data.

Rotate

Rotates the image 90°.

Split

Creates two live images, side by side.

Text

Places the text cursor on the image.

Worksheet

Displays the Worksheet.

Zoom

Activates a zoom window on the image.

S Y S T E M

R E F E R E N C E

3 - 15

3 System Presets

The system displays a new screen when you select ReadySet, presenting the choices described below. To reaccess the Preset Main Menu screen and retain new screen selections, roll the trackball to the OK button and then press the SET key. To reaccess the Preset Main Menu screen and discard new screen selections, roll the trackball to the Cancel button and then press the SET key. Selection 1

ReadySet Icon Display

Option(s)

Allows you to...

Always On With On-screen menu

Display the ReadySet icons on the image screen at all times or display the ReadySet icons only while an on-screen menu is active.

To add an item to the ReadySet list: Note: You can add up to six ReadySet items.

1. Roll the trackball to an item in the Selectable column and then press the SET key. The system highlights the item. 2. Roll the trackball to the Add button and then press the SET key. The item is moved to the bottom of the Order column and its icon displays at the bottom of the Preview box. To delete an item from the ReadySet list: 1. Roll the trackball to an item in the Order column and then press the SET key. The system highlights the item. 2. Roll the trackball to the Delete button and then press the SET key. The item displays in the Selectable column and its icon is removed from the Preview box.

1

Requires software version 2.0 or higher

3 - 16

S Y S T E M

R E F E R E N C E

3 System Presets

To rearrange items in the ReadySet list: 1. Roll the trackball to an item in the Order column and then press the SET key. The system highlights the item. 2. To move the item up or down in the list, roll the trackball to the Up or Down button and then press the SET key as required to reposition the item. The icon for the item is repositioned in the Preview box. To separate items into groups in the ReadySet list: Note: You can add up to three separators.

1. Roll the trackball to the Separator button and then press the SET key. The system displays the separator at the bottom of the Order column and the Preview box. 2. To move the separator up or down in the list, roll the trackball to the Up or Down button and then press the SET key as required to reposition the separator. The icon for the separator is repositioned in the Preview box.

S Y S T E M

R E F E R E N C E

3 - 17

3 System Presets

Default Settings – Exam Configuration Selections The system displays a new screen when you select Default Settings, presenting the choices described below. To reaccess the Preset Main Menu screen and retain new screen selections, roll the trackball to the Save button and then press the SET key. To reaccess the Preset Main Menu screen and discard new screen selections, roll the trackball to the Cancel button and then press the SET key. To automatically change all selections on this screen to factory defaults for the selected exam, roll the trackball to the Default button and then press the SET key. Repeat this process as required to restore defaults for other exam types.

1

Selection

Option(s)

Allows you to...

Exam

Abd OB Early OB Breast Thyroid Testicle GYN Ortho Cardiac Urology Cranial Rectal1 EM1

Select an exam for which you want to specify default settings to automatically become active when the exam is activated. The system lists only the exam types enabled on the User-Defined Exam List configuration screen.

Pictogram List

Select pictograms to display as selections when the PICTOGRAM key is pressed during the selected exam. See page 3-19 for more information.

Text Annotation

Select labels for anatomy and position to display as menu selections for the exam. See page 3-21 for more information.

Biopsy

On Off

Activate the Biopsy function automatically when the selected exam is activated.

Automatic Freeze Response

Cine Caliper Text Picto None

Select the system response when the FREEZE key is pressed. Cine activates the CINE function. Caliper activates the Measurement function. Text activates the Annotation function. Picto activates the Pictogram function. None freezes the image without changing the current function; if no function is active, the system activates the CINE function.

Bypass M Cursor Display

On Off

Select the system response when the M key is pressed. Select this check box to immediately display M-mode. De-select the check box to initially display an M-mode cursor in the 2D-mode image; the M key must then be pressed a second time for full M-mode to display.

2D/M Display Format

40/60 1/2-1/2 1/3-2/3

Specify the image screen layout when two imaging modes are active. 40/60 presents 2D-mode in the left 40% of the screen and the M-mode sweep in the right 60% of the screen. 1/2-1/2 presents 2D-mode on the right side of the upper 1/2, with M-mode in the lower 1/2. 1/3-2/3 presents 2D-mode on the right side of the upper 1/3, with M-mode in the lower 2/3.

Requires software version 2.0 or higher

3 - 18

S Y S T E M

R E F E R E N C E

3 System Presets

Selecting Pictograms To begin pictogram selection, roll the trackball to the Pictogram List button on the Default Settings screen and then press the SET key. The system displays the Customize Pictogram List screen, with the full selection of available pictograms on the top. On the bottom, the system displays the pictogram menu selections that will appear for this exam when the PICTOGRAM key is pressed. To add pictogram selections: 1. Locate the required pictogram in the selection of available pictograms. To scroll through the selection, roll the trackball to the up or down arrow on the scroll bar and then press the SET key. 2. Roll the trackball to the displayed pictogram and then press the SET key. The system displays a box around the selected pictogram. 3. Roll the trackball to the Add button and then press the SET key. The pictogram is copied to the next available cell in the Pictogram List Display Preview on the bottom. You can copy the same pictogram repeatedly. To delete pictogram selections: 1. Locate the required pictogram selection. To scroll through the selections, roll the trackball to the right or left arrow on the scroll bar and then press the SET key. 2. Roll the trackball to the displayed pictogram and then press the SET key. The system displays a box around the selected pictogram. 3. Roll the trackball to the Delete button and then press the SET key. The system deletes the pictogram from the Pictogram List Display Preview on the bottom. To insert a pictogram between existing selections: 1. Roll the trackball to an available pictogram and then press the SET key. The system displays a box around the selected pictogram. 2. Roll the trackball to position the cursor in the Pictogram List Display Preview, on the pictogram to the right of the position in which you want to add the new pictogram, and then press the SET key. The system displays a box around the selected pictogram. 3. Roll the trackball to the Insert button and then press the SET key. The system inserts the pictogram to the left of the selected position in the Pictogram List Display Preview.

S Y S T E M

R E F E R E N C E

3 - 19

3 System Presets

To reposition the transducer inside a pictogram: 1. Roll the trackball to position the cursor on a pictogram in the Pictogram List Display Preview and then press the SET key. The system displays a box around the selected pictogram. 2. Roll the trackball to the Transducer button and then press the SET key. 3. Roll the trackball to position the transducer indicator and then press the SET key. To rearrange pictogram selections: 1. Roll the trackball to a pictogram in the Pictogram List Display Preview on the bottom and then press the SET key. The system displays a box around the selected pictogram. 2. Roll the trackball to the > button and then press the SET key. The selected pictogram moves left or right on the Pictogram List Display Preview page. 3. Continue pressing the SET key with the trackball positioned on the > button to step the pictogram left or right. 4. To move the pictogram to a higher page number, use only the >> button. To move the pictogram to a lower page number, use only the