Siemens X300 Instruction Manual

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ACUSON X300 Ultrasound Imaging System Instructions for Use

10348702-VFT-001-01-01

Siemens Medical Solutions USA, Inc. 10348702 REV 01

Page 2

Software Version 3

Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043-1344 U.S.A.

(800) 498-7948 (650) 969-9112

February 2008 Printed in the Republic of Korea.

Siemens ACUSON X300, THI, MultiHertz, DIMAQ, microCase, QuickSet, SuppleFlex, Evolve Package, SynAps, TGO, DTI, 3-Scape, Axius, Clarify, SieClear, SieScape, Velocity Vector Imaging, AcuNav, and SwiftLink are trademarks or registered trademarks of Siemens AG or its subsidiaries and affiliates.

Windows, CIDEX, CIDEX Plus, CIDEX OPA, Milton, Virkon, STERRAD and Gigasept FF are registered trademarks of their respective owners.

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

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

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Chapter 1 Introduction

Chapter 2 Safety and Care

Chapter 4 Examination Fundamentals

Chapter 5 Transducer Accessories and Biopsy

Chapter 6 Transesophageal Transducer

Appendix A Technical Description

Appendix B Control Panel

Appendix C On-screen Controls

Appendix D Acoustic Output Reference

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.

General overview of the diagnostic ultrasound imaging system.

Detailed information on system safety and how to care for and maintain the system, transducers, and transducer accessories.

System Setup Chapter 3 Detailed descriptions of how to transport, set up, and prepare the system for use,

including transducer connection and system startup procedures.

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

Attachment procedures for transducer accessories and an explanation of the biopsy (puncture) function, including a procedure for needle path verification.

Description of the transesophageal transducer, including cleaning and care information for the transducer.

Technical description of the ultrasound system.

Explanation of all controls and keys on the control panel, alphanumeric keyboard, and optional footswitch.

Explanation of all on-screen controls, including menus and soft key selections.

Acoustic output reporting tables.

INSTRUCTIONS FOR USE i

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ii INSTRUCTIONS FOR USE

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About the User and Reference Manuals

The user and reference manuals consist of the following publications.

Publication Includes

Instructions for Use  Technical description of the ultrasound system

 Safety and care information for the system and compatible transducers  Descriptions of all system controls  Procedures for system setup, examination fundamentals, and the biopsy

function

 Acoustic output data

Features and Applications Reference*

System Reference*  Description of customizable system settings

Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration*

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

 Descriptions of image acquisition and optimization, including optional imaging

features

 General and exam-specific measurements and calculations  Data management  Explanation of the clinical software programs for use on the ultrasound system

 Information about DICOM connectivity, network capabilities, and external

devices

 Clinical references  Information regarding the electromagnetic compatibility (EMC) testing of this

system

INSTRUCTIONS FOR USE iii

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Conventions

Take a moment to familiarize yourself with these conventions.

Warnings, Cautions, and Notes

Cross-References

Customizable System Settings

Keys and Controls Keys and controls located on the control panel are identified by uppercase,

On-screen Objects On-screen objects such as menu selections, soft key selections, and buttons are

Selection of On-screen Objects

WARNING: Warnings are intended to alert you to the importance of

following the correct operating procedures where risk of injury to the patient or system user exists.

Caution: Cautions are intended to alert you to the importance of following

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

Note: Notes contain information concerning the proper use of the system and/or correct execution of a procedure.

Examples: See also: Biohazards, Safety and Care, Chapter 2, Instructions for Use

See also: Documentation Devices, Chapter 2, System Reference

1 Introduction

System Overview ................................................................................................ 3

System Review.............................................................................................. 4

Intended Use ....................................................................................................... 6

Transducers and Intended Applications......................................................... 7

Image Screen Layout.......................................................................................... 8

Screen Saver.................................................................................................8

Sample Image Screen ................................................................................... 9

Status Bar............................................................................................. 10

User-Defined System Settings......................................................................... 10

QuickSets .......................................................................................................... 10

INSTRUCTIONS FOR USE 1 - 1

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1 Introduction

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1 Introduction

System Overview

The X300 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 standard applications, exam-specific imaging presets, measurements, pictograms, annotations, reports, worksheets, and system diagnostics.

Operating modes for the system include:

 2D-mode

 Split mode

 Dual-mode

 4B-mode

 2D/M-mode

 Anatomical M-mode (for Cardiac imaging)

 Pulsed Doppler

 Color Doppler

 Power Doppler

 Steerable Continuous Wave Doppler

 Auxiliary Continuous Wave Doppler

The system is equipped with a DIMAQ-IP integrated workstation. The workstation provides capabilities for digital acquisition, storage, and review of ultrasound studies. Additional system options provide integration into a networking environment.

See also: Technical Description, Appendix A, Instructions for Use

INSTRUCTIONS FOR USE 1 - 3

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1 Introduction

System Review

15 14

13 12

1 User-adjustable monitor with two

forward-facing speakers 2 Alphanumeric keyboard 3 Back-lit control panel

4 Front handle 5 Storage shelf 6 Transducer cable hanger

7 Transducer ports 8 CW transducer port

9 Footswitch connector 10 Swivel wheel with brake

11 Air filter 12 Black-and-white printer 13 Physio module (with ECG and

8 9

auxiliary connectors) 14 CD/DVD-R/W drive 15 Transducer and gel holders 16 Rear shelf 17 Transducer cable hanger

18 Power (partial) ON/OFF switch ( 19 Articulating arm

)

Example of the ultrasound system, left front view.

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1 Introduction

1 Monitor 2 Cable hanger 3 Power panel with circuit breaker 4 Swivel wheel with brake 5 Input/Output panel

+ +

Example of the ultrasound system, back view.

INSTRUCTIONS FOR USE 1 - 5

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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 X300 ultrasound system supports the following applications:

 Abdomen

 Obstetrics

 Obstetrics (Japan)

 Early Obstetrics

 Gynecology

 Musculoskeletal

 Small Parts

 Breast

 Testicle

 Thyroid

 Urology

 Orthopedic

 Cerebrovascular

 Cardiac

 Peripheral vascular

 Venous

 Renal

 Superficial Musculoskeletal

 Pediatric Abdomen

 Pediatric Echo

 Penile

 Emergency Medicine

 Fetal Echo

 Transcranial

 Digital

 Neonatal Head

 TEE (Adult transesophageal)

SONOVISTA Systems Only

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1 Introduction

Transducers and Intended Applications

Only the following transducers from Siemens are compatible with the Siemens ACUSON X300 ultrasound imaging system:

TRANSDUCER NAME

CH5-2 2.0 – 5.0 MHz 2D, C, D, M Obstetrics, Early Obstetrics, Gynecology, Abdomen,

C8-5 5.0 – 8.0 MHz 2D, C, D, M Pediatric Abdomen, Neonatal Head, Pediatric Echo,

VF10-5 5.0 – 10 MHz 2D, C, D, M Cerebrovascular, Peripheral Vascular, Thyroid,

VF13-5 5.0 – 13 MHz 2D, C, D, M Breast, Thyroid, Testicle, Musculoskeletal, Superficial

VF13-5SP 5.0 – 13 MHz 2D, C, D, M Cerebrovascular, Musculoskeletal, Venous, Small

VF8-3 3.0 – 8.0 MHz 2D, C, D, M Cerebrovascular, Peripheral Vascular, Venous,

P4-2 2.0 – 4.0 MHz 2D, C, D, M, SCW Cardiac, Abdomen, Renal, Gynecology, Obstetrics,

P8-4 4.0 – 8.0 MHz 2D, C, D, M, SCW Pediatric Abdomen, Renal, Pediatric Echo, Neonatal

P5-1 1.0 – 5.0 MHz 2D, C, D, M, SCW Cardiac, Abdomen, Obstetrics, Transcranial, Pediatric

V5Ms 3.5 – 6.0 MHz 2D, C, D, M, SCW Adult transesophageal

EC9-4 4.0 – 9.0 MHz 2D, C, D, M Urology, Obstetrics, Early Obstetrics, Gynecology

EV9-4 4.0 – 9.0 MHz 2D, C, D, M Obstetrics, Early Obstetrics, Gynecology, Emergency

CW2 2 MHz CW Cardiac, Pediatric Echo

CW5 5 MHz CW Pediatric Echo, Cerebrovascular

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 Guidance and Manufacturer's Declaration.

OPERATING FREQUENCY

MODES OF OPERATION INTENDED APPLICATIONS

CURVED AND LINEAR ARRAY TRANSDUCERS

Renal, Urology, Fetal Echo, Emergency Medicine, Peripheral Vascular, Venous

Cerebrovascular

Testicle, Breast, Musculoskeletal, Venous, Orthopedic, Emergency Medicine

Musculoskeletal, Digital, Penile, Cerebrovascular, Venous

Parts

Musculoskeletal, Thyroid, Testicle

PHASED ARRAY TRANSDUCERS

Transcranial, Emergency Medicine

Head

Echo

ENDOCAVITY TRANSDUCERS

ENDOVAGINAL TRANSDUCERS

Medicine

CONTINUOUS WAVE TRANSDUCERS

INSTRUCTIONS FOR USE 1 - 7

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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.

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, Doppler spectrum, and their combinations, sets of calipers, pictograms and annotation text, and CINE icons. An image can be inverted on a vertical axis and reversed on a horizontal axis to facilitate viewing and measurements.

The system displays reduced-size reference images (thumbnails) of images, clips, and volumes stored during the exam.

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.

When the screen saver is activated, the system is automatically placed into freeze mode.

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.

Use the system presets to enable the screen saver feature and to specify the delay period and the background for the blank screen.

Display > Monitor > Enable Screen Saver Display > Monitor > Screen Saver Delay Display > Monitor > Screen Saver Type

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1 Introduction

Sample Image Screen

SIEMENS

13 12 11 10

Example of a typical image screen.

10:15:04 03/03/xx

1 Information for identifying the patient, operator, and the hospital or clinic. 2 Time and Date 3 Panels including Thumbnails with controls for printing, deleting, and deselecting an image, clip, or

volume and Patient Info for displaying patient information.

4 Soft key selections for a mode or function, including controls for image optimization, post-processing,

measurement types, annotations, and playback. Use the corresponding toggle key on the control panel to activate the selection. Rotate the PAGE control on the control panel to access additional selections for the mode or function. Press the PAGE control to access soft key selections for other modes or functions.

5 Page Indicator for the soft key selections. The number of available "pages" for a specific mode or

function are identified by the number of sections in the "page indicator". The highlighted section

corresponds to the displayed "page" of soft key selections. 6 Tab Indicator. Identifies the mode or function for the soft key selections. 7 Status bar. Indicates the function currently assigned to the trackball, SELECT control, UPDATE key,

ESCAPE key. During video recording, provides recording status and an icon to indicate microphone function is active.

8 During the Measurement function, the system displays the Measurement Label menu for the priority

imaging mode and exam type. Use the CALIPER key to access the Measurement Menu. During

annotation, the system displays the library of pre-defined labels for identifying body position and

anatomical structures by exam type. 9 Imaging Parameters. Displays settings for parameters adjusted by the soft key selections.

Measured Results. Displays values from measurements and calculations when the Measurement

function is active. 10 Transducer Frequency 11 Gain for the priority mode 12 Active Exam type 13 Active transducer name

INSTRUCTIONS FOR USE 1 - 9

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1 Introduction

Status Bar

Icon Description

Indicates recording status during video recording using a VCR or DVR. A red icon displays during recording and a white icon displays during pause or stop. The recording time also displays beside the icon.

Indicates the function currently assigned to the SELECT control.

Indicates the function currently assigned to the UPDATE key.

Indicates the function currently assigned to the ESCAPE key. Press the ESCAPE key to cycle through the functions for other active modes under control of the key, if any.

Indicates the function currently assigned to the trackball. Press the SET key to cycle through other functions under control of the trackball, if any.

When displayed, indicates recording function with the built-in microphone is activated.

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.

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2 Safety and Care

Operating Safety and Environment................................................................... 3

System Symbols............................................................................................ 3

Labels............................................................................................................ 7

Biohazard Considerations.............................................................................. 9

Note on Fetal Examinations ................................................................. 10

Acoustic Output — Mechanical and Thermal Indices ..................................10

Mechanical and Thermal Indices.......................................................... 11

Transmit Power Control........................................................................ 12

Transmit Power Display........................................................................ 13

Imaging Functions that Change Acoustic Output .................................14

Transducer Surface Temperature Limits .....................................................15

Electrical Safety...........................................................................................15

Level of Protection Against Electrical Shock — Transducers ............... 17

Defibrillators .........................................................................................17

Pacemakers .........................................................................................17

Possible Combinations with Other Equipment...................................... 17

Ultrasound System — Care ............................................................................. 18

Daily Checklist............................................................................................. 18

Maintenance................................................................................................ 19

Repair................................................................................................... 19

Siemens Authorized Care..................................................................... 19

Cleaning and Disinfecting............................................................................ 21

Cleaning and Disinfecting the System.................................................. 21

Cleaning an Air Filter............................................................................ 23

Caring for the Battery Pack.......................................................................... 25

Battery Pack Location ..........................................................................25

Battery Pack Replacement and Disposal .............................................26

Battery Pack Disposal .......................................................................... 27

Documentation and Storage Devices — Care................................................ 28

Transducers — Care......................................................................................... 28

Cleaning and Disinfecting Transducers ....................................................... 29

IPX8 Immersion Levels......................................................................... 31

Approved List of Pre-Cleaners and Low-Level Disinfectants................ 32

Approved List of Disinfectants .............................................................. 33

Sterilizing Transducers — VF13-5SP .......................................................... 34

Storage........................................................................................................ 34

Repair.......................................................................................................... 34

Protective case............................................................................................ 34

INSTRUCTIONS FOR USE 2 - 1

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2 Safety and Care

Transducer Accessories — Care..................................................................... 35

Transducer Sheaths ....................................................................................35

Storage................................................................................................. 35

Gel Pad........................................................................................................ 36

Storage................................................................................................. 36

Needle Guide Bracket Kits........................................................................... 36

Storage and Transportation..................................................................36

Cleaning, Disinfecting, and Sterilizing — Needle Guide Bracket Kits ... 36

Universal Needle Guide, Stainless ....................................................... 37

Storage................................................................................................. 37

Product Recycling and Disposal..................................................................... 38

2 - 2 INSTRUCTIONS FOR USE

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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.

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

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

Control Panel Task Light Indicator Light

Monitor Menu Control Monitor Menu Control, left (decrease) Monitor Menu Control, right (increase) Monitor Picture menu icon

Monitor Function menu icon

Monitor OSD menu icon

Monitor menu Exit icon

Monitor Contrast

Monitor Brightness

Protective Earth Ground

Signal Earth Ground

INSTRUCTIONS FOR USE 2 - 3

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2 Safety and Care

Symbol Explanation

B/W

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

Equipotential Connection

Footswitch Connector

Printer Connection

Black and White Printer Connection Video Luma/Color

Video Red, Green, Blue

VGA

Electronic Array Transducer Port

Continuous Wave Doppler Transducer Port

Unlocked position

Locked position

Audio

Shelf Weight Restriction

ON only for MAINS control

OFF only for MAINS control

Power "On" standby switch

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2 Safety and Care

Symbol Explanation

ECG Socket

IPX8

Protected against the effects of continuous immersion in water Do not open. Refer servicing to qualified service personnel

Danger: Risk of explosion if used in the presence of flammable anesthetics

Manufacturer's declaration of product compliance with applicable

0123

EEC directive(s) and the European Notified Body

Manufacturer's declaration of product compliance with applicable EEC directive(s)

UL symbol for listing as recognized components for Canada and

E170920

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 classified symbol for Canada and United States of America

-40ºC

2006

60ºC

Bar Code

Date of Manufacture symbol with the date below

Do not install wet

Location of air filter

Storage temperature range (example)

Indicates this side up

Do not stack

Shipping weight (example)

Do not allow to get wet

Fragile. Handle with care

INSTRUCTIONS FOR USE 2 - 5

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2 Safety and Care

Symbol Explanation

Do not dispose of by dumping in garbage. Use a separate collection for electrical and electronic equipment.

Fuse

Pinch hazard.

Control panel height adjustment

Do not lean against the monitor.

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2 Safety and Care

Labels

1 Monitor label 2 System warning and Certification label 3 Identification label

Location of labels.

+ +

INSTRUCTIONS FOR USE 2 - 7

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2 Safety and Care

Example of monitor label.

Example of system warning label with certification labels.

Diagnostic Ultrasound System ACUSON X300 Model Manufacture Date

(1P)Model No.

(S)Serial No. Product Status Number

Siemens Medical Solutions USA, Inc. Mountain View

CA 94043 USA

Made in Korea

System

IVK

Example of identification label.

2 - 8 INSTRUCTIONS FOR USE

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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.

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.

INSTRUCTIONS FOR USE 2 - 9

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2 Safety and Care

Note on Fetal Examinations

The following recommendation is excerpted from the National Institute of Health in the United States of America. 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.

In August 1994, the Food and Drug Administration (FDA) notified the medical community and the ultrasound industry regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and to discourage patients from having sonograms for non-medical reasons.

The American Institute of Ultrasound in Medicine (AIUM) has also advocated the responsible use of diagnostic ultrasound for all fetal imaging (August 2005).

Acoustic Output — Mechanical and Thermal Indices

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.

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 shipped with the ultrasound system.

See also: Acoustic Output Reference, Appendix D, Instructions for Use

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2 Safety and Care

Mechanical and Thermal Indices

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.

SIEMENS

Location of mechanical and thermal indices on the image screen.

ACUSON X300

17:34:43 Th 03/01/xxxx

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

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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.

See also: Imaging Functions that Change Acoustic Output, p. 2-14

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 increase the transmit power:

 During real-time imaging, press the toggle key for P upward to increase transmit

power.

To decrease the transmit power:

 During real-time imaging, press the toggle key for P downward to decrease

transmit power.

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2 Safety and Care

Transmit Power Display

The transmit power range is from 0% to 100%. Selecting 100%, in combination with other system controls or functions, generates the maximum acoustic intensity and mechanical index for each transducer, where:

: ≤ 720 mW/cm2 and MI ≤ 1.9

SPTA.3

Percentage (%) Decibels (dB) Percentage (%) Decibels (dB)

100% 0 dB 4.0% -28 dB 79% -2 dB 3.2% -30 dB 63% -4 dB 2.5% -32 dB 50% -6 dB 2.0% -34 dB 40% -8 dB 1.6% -36 dB 32% -10 dB 1.3% -38 dB 25% -12 dB 1.0% -40 dB 20% -14 dB 0.79% -42 dB 16% -16 dB 0.63% -44 dB 13% -18 dB 0.40% -46 dB 10% -20 dB 0.50% -48 dB

7.9% -22 dB 0.32% -50 dB

6.3% -24 dB 0.25% -52 dB

5.0% -26 dB 0.20% -54 dB

Comparison of decibels to percentages.

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

SIEMENS

ACUSON X300

17:34:43 Th 03/01/xxxx

Location of power display on the image screen.

INSTRUCTIONS FOR USE 2 - 13

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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  M-mode cursor  Color and Power ROI Position and Size; Steering Angle for linear array

transducers

 Doppler Gate Position and Size; Steering Angle for linear array transducers  Doppler PRF  Color PRF  Exam Type  Field of View (Scan Angle); 2D Steering Angle for linear array transducers  Focus  Zoom  Frame Rate  Freeze  Image Depth  Imaging Mode  Multi-Frequency  Power On/Off  System Presets and QuickSets  THI  Resolution/Speed  Simultaneous/Update  Transducer  Gel pad use

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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.

Note: The systemic uncertainty of the transducer surface temperature is estimated as 1.39° C.

Maximum Temperature

Transducer TMM Still Air

CH5-2 <41.4° C <42.5° C C8-5 <33.1° C <43.5° C VF8-3 <33.5° C <46.2° C VF10-5 <41.1° C <42.7° C VF13-5 <41.4° C <42.7° C VF13-5SP <41.2° C <42.5° C EV9-4 <42.3° C <43.6° C EC9-4 <41.7° C <43.8° C P4-2 <42.2° C <44.1° C P5-1 <41.5° C <46.0° C P8-4 <41.2° C <42.1° C V5Ms <41.6° C <44.3° C CW2 <31.5° C <35.5° C CW5 <27.0° C <32.0° C

TMM = Tissue Mimicking Material

Electrical Safety

WARNING: For systems used in the U.S.A.: 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 or a MAINS power cord 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.

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2 Safety and Care

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 Siemens-approved third party perform all on-board connections of documentation and storage devices to the ultrasound system.

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.

Caution: To reduce the risk of fire and subsequent equipment damage, use only 26 gauge

(0.14 mm

) or heavier wire for the cable connecting to the Ethernet port located on the

ultrasound system.

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.

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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 linear, curved, and phased 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.

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 Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

The ultrasound system supports three on-board documentation devices. The ultrasound system can support two on-board documentation devices at one time.

On-board peripheral devices must be installed by an authorized Siemens representative or by a Siemens-approved third party. Devices installed by other people will be at the user's risk and may void the system warranty.

INSTRUCTIONS FOR USE 2 - 17

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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, and transducers, 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.

WARNING: To avoid electrical shock, you must visually inspect a transducer prior to use. Do not

use a transducer that has a cracked, punctured, or discolored casing or a frayed cable.

Discoloration Exception: The use of the approved disinfectants, Cidex OPA and Gigasept FF, may cause discoloration of transducer housings, including the face of the transducer. You can continue to use a transducer if it is discolored due to the use of these specific disinfectants only.

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.

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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 ultrasound 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 Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

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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, and transducers, 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 only when recommended for cleaning the trackball assembly. Use the recommended cleaning procedure.

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.

The filter location is marked with the air filter symbol.

Location of air filter.

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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 air filter tray and pull it out of the system.

1 Air filter 2 Air filter tray

Removing the air filter tray.

3. Remove the filter.

4. 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.

5. Reinsert the filter into the filter tray.

6. Slide the air filter tray back into the ultrasound system.

7. Plug the power cord into the power outlet.

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2 Safety and Care

Caring for the Battery Pack

WARNING: Do not strike or drop the battery pack because this can cause heat generation,

bursting, or fire. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

WARNING: Do not use the battery pack if it leaks fluid or has changed shape. If skin or clothing

comes in contact with fluid from the battery pack, thoroughly wash the area immediately with clean water. If any fluid comes in contact with a user's eyes, immediately flush their eyes with water and seek medical attention.

WARNING: Do not allow the battery pack to contact water. Compromising the structural integrity

of the battery pack can result in leakage or explosion and the potential for personal injury.

WARNING: Do not disassemble the battery pack. Compromising the structural integrity of the

battery pack can result in leakage or explosion and the potential for personal injury.

The battery pack is designed to maintain system memory for a maximum of forty minutes.

The length of the charge time is three hours.

Battery Pack Location

The battery pack is located on the front side of the ultrasound system, where the power is located. The battery pack cover must be removed to access the battery pack.

1 Battery pack location

Battery pack location.

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2 Safety and Care

Battery Pack Replacement and Disposal

Replace the battery pack when it is no longer able to hold a charge.

 When the system is used with the Mobile QuickStart option and frequently

disconnected from the AC power (for a duration of greater than 20 minutes), replace the battery every 6 months.

 When the system is used with the Mobile QuikStart option and only occasionally

disconnected from the AC power (for a duration of approximately 20 minutes), replace the battery every year.

1 AC OK indicator LED 2 Battery pack charge indicator LED

+ +

Example of an AC Tray panel with the battery pack charge indicator LED.

The battery pack charge indicator LED is located at the rear of the system, on the AC Tray panel. A green blinking LED indicates that the battery is actively charging. A solid green LED indicates that the battery pack is fully charged. If the LED is not illuminated, then there is a problem with the battery pack, or the battery pack may be missing.

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2 Safety and Care

Battery Pack Disposal

Caution: Never dispose of a battery pack by burning or by flushing into any waste water system,

for example, a lavatory. Compromising the structural integrity of the battery pack can result in leakage or explosion and the potential for personal injury.

Caution: Collect and dispose of used battery packs separate from other waste. Do not throw

into trash.

The battery pack should be recycled according to local, state and federal regulations. Use a battery collection program available in your country to dispose of the battery pack. The following agencies may be contacted for further collection information:

 Australia – Australian Battery Recycling Program (AMTA)  Austria – UFB  Belgium – Bebat  Canada – Rechargeable Battery Recycling Corporation (RBRC)  Denmark – BatteriForeningens  European Union – European Portable Battery Association  France – Societe de Collecte et de Recyclage des Accumulateurs (SCRA)  Finland – (NBA)  Germany – Stiftung Gemeinsames Rucknahmesystem Batterien (GRS)  Italy – COBAT  Japan – Battery Association of Japan  Netherlands – Stibat  Norway – REBATT AS  Portugal – AGEFE  Sweden – CT  Switzerland – Batterieentsorgungs-Selbsthilfeorganisation (BESO)  United Kingdom – REBAT  United States of America – Rechargeable Battery Recycling Corporation (RBRC)

Note: If a local battery recycling program does not exist then return used batteries to the address below. When returning batteries, label the package: "Attn.: Battery Recycling".

Siemens AG Medical Engineering TD ML RE Betr.: Battery Recycling Am Pestalozziring 3 D-91058 Erlangen GERMANY

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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.

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, 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

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.

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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.

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.

See also: Transesophageal Transducer, Chapter 6, Instructions for Use

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2 Safety and Care

To clean 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. If water is not effective, then you can use an approved pre-cleaner or low-level disinfectant.

3. Carefully wipe the entire transducer, including the cable and connector.

4. After cleaning or disinfecting, use a clean cloth to dry the transducer.

To disinfect or 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 disinfectant manufacturer's instructions for disinfection or high-level disinfection.

5. After disinfecting or high-level disinfecting, use a clean cloth to dry the transducer.

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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.

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.

Endocavity Linear Curved Phased Continuous

Wave (CW)

IPX8 Immersion Levels.

Caution: Do not immerse the label located on the cable of the CW transducer.

Note: Intraoperative transducers are immersible up to the strain relief on the connector.

INSTRUCTIONS FOR USE 2 - 31

V5Ms

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2 Safety and Care

Approved List of Pre-Cleaners and Low-Level Disinfectants

The following matrix provides a list of approved pre-cleaners and low-level disinfectants for all transducers.

Enzol Transeptic Hi-Tor Plus Theracide Plus T-Spray II Super SaniCloth

CH5-2

C8-5

VF8-3

VF10-5

VF13-5

VF13-5SP

EV9-4

EC9-4

P4-2

P5-1*

P8-4

V5Ms

CW2

CW5

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

* = Compatible pre-cleaners and low-level disinfectants for the P5-1 transducer include: T-Spray, ANIOS, Wavicide-01, MetriZyme, and Klenzyme.

9 9 9 9 9 9 9 9 9 9 9 9 9 9

9 9

9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9

NC NC NC NC NC NC

9 9 9 9 9 9 9 9

NA NA

9 9 9 9 9 9 9 9 9 9 9 9

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2 Safety and Care

Approved List of Disinfectants

The following matrix provides a list of approved disinfectants for all transducers.

Note: The approved disinfectants, Cidex OPA and Gigasept FF, may discolor transducer housings, including the face of the transducer. There is no associated degradation of imaging performance or transducer reliability.

Cidex Cidex Plus Cidex OPA Milton Virkon Gigasept FF

CH5-2

C8-5

VF8-3

VF10-5

VF13-5

VF13-5SP

EV9-4

EC9-4

P4-2

P5-1

P8-4

V5Ms

CW2

CW5

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

9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9

9 9 9 9

9 9 9 9 9 9 9 9 9 9 9 9

9 9

9 9 9

9 9 NC NC

9 9

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2 Safety and Care

Sterilizing Transducers — VF13-5SP

Caution: The transducers have been designed and tested to be able to withstand sterilization as

recommended by the manufacturer of the sterilization system. Carefully follow the sterilization manufacturer's instructions.

The STERRAD® sterilization system, a hydrogen peroxide gas plasma sterilization system, is approved for use with the listed intraoperative transducer(s).

 VF13-5SP

To sterilize a transducer with the STERRAD system:

Note: This procedure applies to the VF13-5SP transducer only.

1. Disconnect the transducer from the system.

2. Thoroughly clean, rinse, and dry the transducer.

3. Carefully follow the manufacturer's instructions for sterilization.

Storage

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

See also: Technical Description, Appendix A, Instructions for Use

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.

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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.

Transducer Sheaths

WARNING: There have been reports of severe allergic reactions to medical devices containing

WARNING: To minimize the risk of cross-contamination and infectious diseases, endocavity or

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: Only a sterile transducer sheath provides the sterile barrier required for surgical

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.

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.

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.

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.

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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.

See also: Transducer Accessories and Biopsy, Chapter 5, Instructions for Use

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.

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.

See also: Transducer Accessories and Biopsy, Chapter 5, Instructions for Use

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 — Needle Guide Bracket Kits

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.

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2 Safety and Care

CH4-1, SG-4, and SG-3 Needle Guide Bracket Kits

Disposable 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 needle guide for use with the CH4-1, SG-4 and SG-3 bracket kit is a single-use item. Refer to the in-box instructions for disposal instructions.

Reusable Bracket

WARNING: Needle Guide Bracket kits are packaged non-sterile. High-level disinfect these

products prior to their first use.

Refer to the in-box instructions for attachment and care procedures, including cleaning and high-level disinfecting procedures for the bracket.

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 121°C to 123°C 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.

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2 Safety and Care

Product Recycling and Disposal

Symbol Explanation

Products bearing this symbol are subject to the European Community directive 2002/96/EC on waste electrical and electronic equipment (WEEE), amended by directive 2003/108/EC. For take-back and disposal of the product, its components or accessories, please contact Siemens Medical Solutions Customer Service or your Siemens regional office.

Batteries and packaging may be required by local laws and regulations to be taken back and disposed at no cost to the customer. Disassembly instructions applicable to this device are prepared for treatment facilities to properly and safely remove electronic components for appropriate treatment and recycle.

For more information on the take-back and disposal of batteries and packaging, or on disassembly instructions, please contact Siemens Medical Solutions Customer Service or your Siemens regional office.

2 - 38 INSTRUCTIONS FOR USE

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3 System Setup

Initial Setup ......................................................................................................... 3

Moving the System ............................................................................................. 3

Swivel Locking Brake ....................................................................................4

Front Swivel Locking Brake.................................................................... 4

Back Swivel Locking Brake ....................................................................5

Prior to the Move ........................................................................................... 6

During the Move ............................................................................................ 8

Shipping the System...................................................................................... 9

After the Move ............................................................................................... 9

System Startup .................................................................................................10

Plugging in the System................................................................................10

Supplying Power to the System................................................................... 11

QuickStart Feature (Battery-Powered Standby Mode) ......................... 13

Adjusting Controls on the Monitor................................................................ 14

Controls on the Monitor ........................................................................ 14

Adjusting Brightness and Contrast .......................................................15

Adjusting the Monitor with the Monitor Menu Selections ...................... 16

Audio and Microphone Volume ............................................................ 17

Connecting and Disconnecting Transducers ............................................... 18

Array Transducers................................................................................ 19

Continuous Wave Transducers ............................................................ 21

Protective Transducer Holder...............................................................22

Transducer Cable Management ........................................................... 23

Connecting System Accessories ................................................................. 23

Footswitch ............................................................................................ 23

ECG (EKG) Cables .............................................................................. 24

Input/Output Panel Connections..................................................................... 24

Connecting Peripheral Equipment ............................................................... 26

Serial Port............................................................................................. 27

System Ergonomics ......................................................................................... 28

General System Settings .................................................................................30

Modifying Hospital or Clinic Name............................................................... 30

Setting System Date and Time .................................................................... 30

Configuring the Documentation Controls..................................................... 33

Software Installation......................................................................................... 34

Software-Based Option Installation ................................................................ 35

INSTRUCTIONS FOR USE 3 - 1

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Initial Setup

The ultrasound system is initially unpacked and installed by a Siemens representative. Your Siemens representative will verify the operation of the system. Any transducers, documentation and storage devices, accessories, and options delivered with your system are also connected and installed for you.

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

See also: Daily Checklist, Safety and Care, Chapter 2, Instructions for Use

Moving the System

WARNING: 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.

WARNING: To avoid damage to the monitor and the potential for personal injury to the user,

ensure the monitor does not swivel during transport. Lock the vertical position of the flat panel monitor prior to moving the ultrasound system according to the directions provided in this section of the instructions.

Caution: Do not push the flat panel monitor to move the system. Pushing on the flat panel

monitor can cause loss of control over the system and damage to the moving parts of the flat panel monitor.

Caution: Do not lean on the flat panel monitor. Subjecting the flat panel monitor to heavy loads

or extreme pressure can damage the ultrasound 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.

Caution: To prevent damage to the system during a move, retract or close any doors and trays

on the documentation devices or components on the ultrasound system. Ensure components do not protrude from the system.

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.

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Swivel Locking Brake

The ultrasound system has four swivel locking brakes. The two front brakes each have a locking lever, a swivel lever, and a release lever. The two back brakes each have a locking lever, and a release lever. Set the swivel locking brakes with the levers on each wheel.

Front Swivel Locking Brake

1 OFF (release lever) 2 STOP (locking lever) 3 × (swivel lever)

Example of wheel with locking brake (unlocked).

To lock the brake:  Press the STOP lever down with your foot into the locked position.

To release the brakes:  Press the Off lever down with your foot to release the brake.

To lock the swivel:

 Press the × lever with your foot until the swivel brake locks into place.

To release the swivel:

 Press the OFF lever down with your foot until the brake unlocks and the × lever

releases.

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Back Swivel Locking Brake

Example of wheel with locking brake (locked). Example of wheel with locking brake (unlocked).

To lock the brake and the swivel for each wheel:

 Using your foot, press the "ON" lever into the lowest position (locked).

To release the brakes and the swivel:

 Using your foot, press the "OFF" lever to release the brake.

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Prior to the Move

1. Power off the ultrasound system. The power (partial) on/off ( ) switch is located on the upper left of the control panel.

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. Retract or close any doors or trays of the documentation devices or components on the ultrasound system.

+ +

Retracting open doors or trays.

6. Disconnect off-board documentation devices from the system.

7. Transport gel, video tapes, and CD/DVD disks separately.

8. Disconnect the optional footswitch.

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9. Lock the position of the flat panel monitor for transport:

a. Align the flat panel monitor to the front, center of the ultrasound system. b. Push and rotate the transport lock into the locked position. Ensure the locking

pin engages with the hole on the articulating arm.

1 Pin hole 2 Transport lock

Example of transport lock in the unlocked position.

1 2

1 Pin 2 Pin hole 3 Transport lock

Example of transport lock in the locked position.

Example of monitor in vertical position for transport.

10. Release both the front and rear brakes.

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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.

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.

Caution: For systems installed with an on-board documentation device located on the rear shelf

of the ultrasound system, avoid damage to cables and connectors protruding from the documentation device, particularly when moving the system around corners or through doorways.

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.

System Startup

The first step to operating the ultrasound system is to connect the system to a power source.

Plugging in the System

WARNING: For systems used in the U.S.A.: To ensure grounding reliability, only connect the

system to a hospital-grade power outlet.

The ultrasound system has a non-detachable power cord.

12 34

+ +

1 Equipotential connector 2 MAINS circuit breaker 3 MAINS Voltage Selector 4 Accessory Outlet Output

Voltage Selector

5 Status Indicator (for Service

diagnostics)

6 Connector cover for power cord

Example of power panel.

To plug in the system:

 Connect the power cord to the MAINS supply:

– 200V~ to 240V~ systems: connect the power cord to a standard MAINS

receptacle. For example, a "Schuko" receptacle (CEE 7-7 standard).

– 100V~ to 120V~ systems used in the U.S.A.: connect the power cord to a

hospital-grade MAINS receptacle.

– 100V~ to 120V~ systems outside the U.S.A.: connect the power cord to a

standard MAINS receptacle.

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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.

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 On to Off.

Caution: Wait approximately 20 seconds between powering the system off and then on again.

This allows the system to complete its shutdown sequence.

Power on/off button display System status:

Blue Powered on Amber Stand-by mode Off (not lit) Powered off

To power on the system:

1. Before using the system, perform the Daily Checklist.

See also: Daily Checklist, Safety and Care, Chapter 2, Instructions for Use

2. Verify the power cord is plugged into the system and then into the power supply.

3. Power on (

) the ultrasound system.

When powered on, the system runs through a series of self-diagnostic and calibration tests. The tests last a few minutes, 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.

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To power off the system:

Note: To cancel the power off procedure, select the Cancel button in the System Shut Down

dialog box.

1. Briefly press the partial power on/off ( ) button on the upper left of the ultrasound system.

The system displays the System Shut Down dialog box.

2. Select the Power off button.

Wait approximately 30 seconds before powering on the ultrasound system.

Note: In case the system is down, use the compulsory shutdown by pressing and holding the power on/off (

) button for at least five seconds.

To restart the system:

1. Briefly press the partial power on/off (

) button on the upper left of the ultrasound

system.

The system displays the System Shut Down dialog box.

2. Select the Restart button.

The system will power off and restart.

To enter Standby mode:

Note: The system preserves patient data when in standby mode. To avoid the possibility of data loss,

Siemens recommends that you close the current patient study, activate 2D-mode, and wait until the system finishes writing data to external storage media before entering standby mode.

1. Briefly press the partial power on/off ( ) button on the upper left of the ultrasound system.

2. Select Stand-by from the displayed dialog box.

The system enters standby mode.

3. If you are using the QuickStart battery-powered feature, wait approximately 20 seconds after the system powers off before unplugging the ultrasound system.

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To exit Standby mode:

Note: You must wait approximately 20 seconds after the system powers off before powering on ( )

the ultrasound system.

1. If you are using the QuickStart feature, verify the power cord is plugged into the system and into the power supply.

2. Press the partial power on/off (

) button on the upper left of the ultrasound

system. The system is ready for use in less than 15 seconds.

3. To re-enter standby mode, wait approximately 20 seconds after powering on the system.

QuickStart Feature (Battery-Powered Standby Mode)

The QuickStart feature for portable studies decreases the time required to power the system on or off by using the installed battery to place the ultrasound system in a standby status.

The system can maintain the standby status for approximately 40 minutes when the system's power cord is not plugged into the power supply.

When the system is in standby status running on battery power, the power on/off ( button functions as a battery power indicator.

Power on/off button display Battery status:

Steady amber More than 60% charge remaining. Flashing amber (slow) More than 30% charge remaining. Flashing amber (fast) Battery power is low. Flashing amber (fast) with audible beep Battery power is very low. If the system is not plugged

in, it will shut down automatically within 5 minutes.

)

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Adjusting Controls on the Monitor

Use the controls located on the underside of the monitor to directly adjust the brightness and contrast settings of the monitor. Additional settings are available as menu selections from the monitor.

See also: Monitor Menu Selections, p. 3-16

Note: The language setting for the monitor menu is separate from the language setting of the

ultrasound system.

1 Menu

Left, Down (-)

2 3 Monitor On/Off LED 4

Right, Up (+) Control panel task light

5 6 Microphone On/Off LED

12345 6

Example of monitor.

Controls on the Monitor

Monitor button Description

Left (-) Decreases the values of a control, or moves to the left or down. Right (+) Increases the values of a control, or moves to the right or up.

Light Intensity

Briefly press to step cycle through:

 Contrast control  Brightness control  Off

Press and hold Menu and monitor menu with additional controls.

Turns the control panel task light on or off. (Cycles through settings: off, low, mid and high intensity.)

(for at least 8 seconds) to display the

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Adjusting Brightness and Contrast

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.

These processes assure consistent quality in the image display and reduces the potential for image quality issues.

To adjust the brightness or contrast of 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.

1. Press the control on the monitor to display the setting for Contrast or press twice to display the setting for Brightness.

2. Press the

control to decrease the setting or press the control to increase the

setting.

Decrease the setting for darker images or lower contrast; increase the setting for lighter images or higher contrast.

To restore and lock the factory default monitor settings for brightness and contrast:

1. Press the

control on the monitor to display the setting for Contrast or press

twice to display the setting for Brightness.

2. Press the

control and the control simultaneously.

The system restores the factory default settings for the selection.

3. Press and hold the

control or the control (for at lease 5 seconds)

simultaneously.

The system displays the OSD Main Menu is locked message.

4. To unlock the monitor settings, repeat step 3.

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Adjusting the Monitor with the Monitor Menu Selections

You can adjust the monitor controls through the monitor menu.

Monitor Menu Selections

Menu Icon Menu Selection

Picture Contrast Brightness Color Mode Exit

Function Scale Information Memory Recall SBC Exit

OSD Language Half Tone Exit

Exit

To adjust monitor controls from the monitor menu:

1. Press and hold

and simultaneously on the monitor to display the

monitor menu.

2. Press

3. Press

4. Press

5. Press

6. Select the EXIT button or press

or to highlight a selection.

to select a Menu Icon. or to select a menu selection and press to adjust the setting.

or to change the setting.

to confirm the setting and return to the main

Selection screen.

7. To exit the monitor menu, allow the menu to time out (for 10 seconds), or press to select EXIT, and then press again.

Monitor Error Messages

Message Action

NO SIGNAL

OUT OF FREQUENCY SBC ERROR (blank dialog box)

Check the signal cable Check if the operating frequency is out of range Exchange the Monitor

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Audio and Microphone Volume

You can adjust the volume of the speakers. Use the system presets to set a default volume level.

General 1 > Audio

You can also adjust the volume using the volume control on the control panel located above the DGC controls.

Example of the volume control.

To adjust the volume during Doppler:

 Rotate the volume control on the control panel.

To activate the microphone during recording:

1. Press the volume control to activate the microphone.

The system illuminates the LED located on the front of the monitor.

2. To adjust the volume, rotate the volume control.

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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.

Press the TRANSDUCER key on the control panel to change the active transducer.

Note: When three transducers are connected to the system, the names of the transducers display as soft key selections.

Example of transducer ports.

1 Two 260-pin ports for standard array transducers 2 One 260-pin port for standard and specialty array transducers 3 Continuous Wave (CW) Doppler port for CW Doppler pencil transducers

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Array Transducers

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

Connect an array transducer to any of the available array ports.

Example of array 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.

1 Locked 2 Unlocked

Example of locked and unlocked positions of the connector.

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To connect an array transducer:

1. Hold the transducer connector with the cable extending upward from the

connector.

2. 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.

3. 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.

3. Store each transducer in its protective carrying case.

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Continuous Wave Transducers

Caution: You must freeze the system before connecting or disconnecting a CW transducer.

Connect a continuous wave transducer to the round sector port located to the left of the array ports.

Continuous wave transducer port.

1 Connector 2 Retractable connector housing 3 Transducer cable

Example of CW transducer connector.

To connect a continuous wave transducer:

1. Align the connector key until it fits smoothly into the port.

2. Insert the connector into the system port until it locks into position.

To disconnect a continuous wave transducer:

Caution: To avoid damaging the transducer cable, do not pull on the cable to disconnect the

transducer. Use the following instructions.

1. Pull on the connector housing ring to disengage the locking mechanism and

remove the connector from the system port.

2. Store each transducer in its protective carrying case.

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Protective Transducer Holder

Caution: Transducer holders have variable sizes both in depth and diameter. To avoid

transducer damage, you must use the holder and/or insert provided for transducers that have small or large diameter handles or for specialty 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 Point of

attachment 2 Tab 3 Support 4 Holder

3 4

Example of transducer holders.

To remove a transducer holder:

1. Locate the tab underneath the holder.

Note: The tab extends below the point of attachment to the ultrasound system.

2. Press the tab against the holder and pull the holder downward.

To install a transducer holder:

1. Press the tab against the holder.

2. Align the support on the holder with the attachment slot on the system and slide the holder upwards until it snaps into place.

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Transducer Cable Management

WARNING: To avoid injury to the patient or operator, use the cable hooks located on the

ultrasound system to manage one or more transducer cables. Entanglement with the transducer cables could result in injury.

After you have connected and secured a transducer, drape the transducer cable through one of the cable hangers located on the back of the control panel.

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.

Connecting System Accessories

Footswitch label identifying the connector socket.

Footswitch

The ultrasound system has an optional dual-pedal, watertight footswitch.

Ingress Protection

With the exception of the connector on the footswitch, the footswitch meets Ingress Protection level IPX8 of EN 60539 and IEC 60539.

To connect the footswitch to the system:

 Insert the footswitch connector housing into the socket located on the front of the

system.

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ECG (EKG) Cables

The ECG feature allows the system to display a scrolling ECG waveform on the image screen.

ECG label identifying the connector socket.

To connect the ECG cables:

 Insert the six-pin ECG connector into the socket labeled ECG on the left side of

the system.

Input/Output Panel Connections

Audio and video connections are located on the Input/Output (I/O) panel.

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 Instructions for Use. If in doubt, consult the Siemens service department or your local Siemens representative.

See also: Accessories and Options, Technical Description, Appendix A, Instructions for Use

Caution: To ensure proper grounding and leakage current levels, it is the policy of Siemens

to have an authorized Siemens representative or approved third party perform all on-board connections of documentation and storage devices to the ultrasound system. The Instructions for Use lists the peripheral devices specified for use with the ultrasound system.

Caution: To reduce the risk of fire and subsequent equipment damage, use only 26 gauge

(0.14 mm ultrasound system.

) or heavier wire for the cable connecting to the Ethernet port located on the

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1 Status Indicators (for service diagnostics only) 2 Ethernet Connection 3 USB Port 4 RS-232-C Port

5 RGB Out 6 VGA Out 7 S-VHS- In/Out

Y/C In/Out 8 VHS In/Out (BNC)

9 Audio Out 10 Audio In 11 Accessory Power Outlet

Input/output panel connections.

Accessory outlet label.

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

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Connecting Peripheral Equipment

See also: Documentation Devices, Chapter 2, System Reference

On-board peripheral devices must be installed by an authorized Siemens representative or by a Siemens approved third party. Any use of other devices with the system will be at the user's risk and may void the system warranty.

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:

 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:

Equipotential connector located on power panel of imaging system.

– 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.

– 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.

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Example of a peripheral equipment connection and patient environment.

1 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) 2 Ultrasound system 3 Peripheral equipment power

4 Peripheral equipment (EN XXXXX and

IEC XXXXX) 5 RS-232C cable or video in/out 6 Additional Protective Earth (refer to 37 Ultrasound system power

26)

Serial Port

The system has a serial port for connecting to a PC. This port is located on the Input/Output panel.

Peripheral > External RS-232C Port #1 Peripheral > External RS-232C Port #2

Configuring the Serial Port

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

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.

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System Ergonomics

WARNING: Do not lean on the monitor. Doing so might cause the system to tilt over and may

result in the potential for personal injury to the user or patient and/or damage to the system.

You can make the following adjustments to the system:

Monitor – Tilt the monitor for optimal viewing while scanning.

Monitor Arm – Use the monitor arm to extend the monitor forward over the control

panel, and swivel the monitor right or left or swivel the monitor arm right or left.

Example of monitor in tilted and upright positions. Example of monitor swivel and monitor arm

swivel.

Example of monitor arm in forward, extended position.

Example of monitor in non-extended position.

Lighting – A task light is available under the monitor to illuminate the keyboard.

Control Panel – Use the button located under the control panel to adjust the height of

the control panel.

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Example of the location of the button for adjusting the height of the control panel.

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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.

General 1 > Organization > Hospital Name

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:

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 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. You can enter up to 25 characters.

5. Roll the trackball to Save and then press the SET key to store the new settings and exit the system presets.

Setting System Date and Time

The date is displayed numerically on the upper right of the image screen. You can enter a new date and time, and you can select the format in which the date displays on-screen.

Use the system presets to select a date format and to set the date and time.

General 1 > Format > Date Format General 1 > Format > Date & Time Settings

Note: You cannot change the date and time during an active study. Close the active study before

changing date and time.

To select the date format:

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 on the left of the screen and then press the SET key on the control panel.

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.

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To change the system date:

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 and then press the SET key on the control panel.

3. Roll the trackball to Date & Time Settings and press the SET key.

The system displays the Date and Time Properties screen.

4. Enter the date by completing the Date fields:

a. Select a month from the list of months.

b. Select a year from the list of years. c. Select a day from the calendar.

5. Roll the trackball to the OK button or to the Apply button and then press the

SET key.

Note: Selecting OK applies the change and closes the window; selecting Apply applies the

change and leaves the window open.

To change the system time:

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 and then press the SET key on the control panel.

3. Roll the trackball to Date & Time Settings and press the SET key.

The system displays the Date and Time Properties screen.

4. 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.

5. Roll the trackball to the OK button or to the Apply button and then press the

SET key.

Note: Selecting OK applies the change and closes the window; selecting Apply applies the

change and leaves the window open.

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To adjust the time for Daylight Savings:

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 and then press the SET key on the control panel.

3. Roll the trackball to Date & Time Settings and press the SET key.

The system displays the Date and Time Properties screen.

4. Roll the trackball to the Time Zone tab and then press the SET key on the control panel.

5. Select the time zone from the list. If Daylight Savings time is used by that time zone, then a check box displays at

the bottom of the window.

6. To adjust for Daylight Savings time, select the check box.

7. Roll the trackball to the OK button or to the Apply button and then press the

SET key.

Note: Selecting OK applies the change and closes the window; selecting Apply applies the

change and leaves the window open.

To set the time using an Internet time server:

Note: To use the time server option, the system must be configured with access to the Internet.

1. Press the Presets key on the keyboard to access the system presets.

2. Roll the trackball to General 1 and then press the SET key on the control panel.

3. Roll the trackball to Date & Time Settings and press the SET key.

The system displays the Date and Time Properties screen.

4. Roll the trackball to the Internet Time tab and then press the SET key on the control panel.

5. Select the check box to synchronize with an internet time server.

6. Enter the Internet server name in the Server field.

7. To update the time immediately, roll the trackball to the Update Now button, and then press the SET key.

8. To update the time at the next interval, roll the trackball to the OK button or to the

Apply button and then press the SET key.

Note: Selecting OK applies the change and closes the window; selecting Apply applies the

change and leaves the window open.

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3 System Setup

Configuring the Documentation Controls

You can configure the documentation controls for printing and storing. The system stores images, patient reports, and CINE data to its hard disk.

Customize Keys > Print/Store 1 Key Customize Keys > Print/Store 2 Key

To configure the documentation controls:

1. Press the Presets key on the keyboard to access the system presets.

2. Select Peripheral on the left of the screen.

3. For each documentation control (PRINT/STORE1 or PRINT/STORE2, or CLIP STORE), select the required option:

Note: The PC Printer and Disk Store & PC Printer selections are available when you select a PC printer on the Printer screen.

To configure the documentation control to: Select an option:

Store images and patient reports Store Clip data Store 3D volume data Print images and patient reports

Store and print images and patient reports

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

Disk Store

Clip Capture

Volume Store

 B/W Print  Color Print  PC Printer  USB B/W  USB Color  DICOM B/W Print  DICOM Color Print  Disk Store & B/W Print  Disk Store & Color Print  Disk Store & PC Printer  Disk Store & USB B/W  Disk Store & UBS Color

INSTRUCTIONS FOR USE 3 - 33

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3 System Setup

Software Installation

You can install new software or you can re-install existing software. When you install or re-install, you can choose to retain user-defined settings (system presets and QuickSets) or you can remove the user-defined settings. Retaining user-defined settings allows you to use the new software without having to reconfigure the system. Removing user-defined settings allows you to completely reset the system for another purpose or to reset the system in order to re-load all user-defined settings from a back-up.

See also: Software-Based Option Installation, p. 3-35

 To install software and retain all existing user-defined settings, follow the

procedure to install system software.

 To install new software and remove existing user-defined settings, follow the

procedure to reset system software. Removing user-defined settings also removes any installed software-based options.

Note: Siemens recommends that you retain user-defined settings. Whether you retain or remove user-defined settings, you should make a backup copy of system presets and QuickSets before installing software.

Refer to the software installation procedure that accompanies your system software disks.

3 - 34 INSTRUCTIONS FOR USE

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3 System Setup

Software-Based Option Installation

You can install a software-based option on the ultrasound system using a software-based option media.

To install a software-based option:

1. Prepare the system for the software load:

a. Press the Presets key to display the Presets screen.

b. Select Service on the left of the screen. c. Select Service.

d. Delete none from the text box and then click OK.

e. Select Configuration. f. Select Licensing & Components on the left of the screen.

2. Install the software:

a. Press the eject button on the CD/DVD drive on the left side of the ultrasound

system to eject the CD/DVD tray, insert the license disk, and then press the eject button again to load the disk.

b. Select Select New License File on the upper right of the screen.

The system displays the License File to be set section.

c. Select the license file from Browse or from History.

d. Click Save.

The system displays a status dialog box.

e. Click OK.

The software-based options are displayed in the Available Features section.

3. Click OK when the system displays a reboot dialog box.

The system restarts and confirms the installation of the options.

INSTRUCTIONS FOR USE 3 - 35

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3 System Setup

3 - 36 INSTRUCTIONS FOR USE

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4 Examination Fundamentals

Entering Patient Data .........................................................................................3

Retrieving Patient Data for Registration ........................................................ 4

Using the Patient Data Form .........................................................................4

Calendar Tool.........................................................................................5

Fields in the Patient Data Form ..................................................................... 5

Patient — Original .................................................................................. 6

Patient — e-entry ...................................................................................7

History (All Examinations) ......................................................................7

History (OB, Early OB, GYN, Fetal Echo, or EM) — Original Method .... 8

History (C-Vascular, P-Vascular, and Venous)....................................... 9

History (Urology) ....................................................................................9

Institution................................................................................................ 9

Exam ...................................................................................................... 9

Selecting a Scheduled Procedure .................................................................9

Searching the Worklist.......................................................................... 10

Worklist and Procedure Screen............................................................ 11

Selecting Another Procedure................................................................ 12

Editing Patient Data.....................................................................................12

Changing the Exam Type................................................................................. 13

Exam Type Abbreviations............................................................................ 14

Activating a Transducer................................................................................... 15

Changing a Transducer Frequency .............................................................15

Selecting an Operating Mode .......................................................................... 16

2D-Mode and M-Mode Imaging........................................................................ 17

Example Screen Layout...............................................................................17

2D-Mode with Color .......................................................................................... 18

Example Screen Layout...............................................................................18

Doppler .............................................................................................................. 19

Example Screen Layout...............................................................................19

2D-Mode/Doppler Formats................................................................... 19

Optimizing Images............................................................................................ 20

Creating and Viewing Thumbnails .................................................................. 20

Viewing Patient Information in the PatientInfo Tab ....................................... 22

Measurement Function — Overview............................................................... 23

General and Exam-Specific Measurements ................................................ 23

Examination Completion.................................................................................. 24

INSTRUCTIONS FOR USE 4 - 1

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4 Examination Fundamentals

4 - 2 INSTRUCTIONS FOR USE

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4 Examination Fundamentals

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 entered patient information.  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.

See also: Searching the Worklist, p. 4-10

Use the system presets to select the registration method (patient registration form and data entry requirements):

 Original uses the standard patient registration form with conventional

requirements for data entry.

 e-entry displays an overlay of patient identification fields on the Image screen.

General 2 > Common Mode > Patient Registration

Use the system presets to select the order that the tab key moves from field to field on the New Patient Data form.

General 2 > Patient ID > Customize Entry Order

To enter new patient information:

1. Press the NEW PATIENT key located on the control panel. The system displays the New Patient Data form with a text entry cursor

positioned in the Last Name field.

Note: You can also review and edit an existing form by pressing the Patient Data key on the keyboard.

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.

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4 Examination Fundamentals

Retrieving Patient Data for Registration

You can retrieve previously entered patient data for registration from the ultrasound system's hard disk or external media.

To retrieve previously entered patient data:

1. Press the Patient Browser key on the keyboard.

If a patient is currently registered, then the system displays the DIMAQ-IP Image screen. If a patient is not currently registered, then the system displays the DIMAQ-IP Study screen.

2. To display the Study screen (from the Image screen), select the Study Screen button on the left of the screen.

3. Select the location of the patient data from the Disk section of the Study screen.

4. Select the required study at the top of the screen and then select the New button in the Study section of the Study screen.

The system transfers the patient data into the New Patient Data form.

5. Use the keyboard to edit or enter data.

6. To begin the study, select OK.

Using the Patient Data Form

The Patient Data form contains general and exam-specific information.

To: Perform this action:

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

Delete characters Select a button or object on the form Roll the trackball to the button or object and then press

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

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

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.

Press the Backspace key on the keyboard.

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

SET key or press the Enter key on the keyboard. Or, press the 2D control.

Roll the trackball to the Cancel button and then press the SET key, or press the ESCAPE key on the control panel.

4 - 4 INSTRUCTIONS FOR USE

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4 Examination Fundamentals

Calendar Tool

You can display a calendar tool in the Patient Data form for use with the following exam types: OB, Early OB, GYN, Fetal Echo, and EM.

The calendar tool is available for date fields in the History section of the Patient Data form.

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.

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.

Fields in the Patient Data Form

The Patient Data form includes the following sections: Patient, History, Institution, and Exam.

Use the system presets to select the following formats: date, height, and weight.

General 1 > Format

INSTRUCTIONS FOR USE 4 - 5

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4 Examination Fundamentals

Patient — Original

In this field: Enter the…

Last Name

First Name Prefix Dr., Miss, Mrs., Ms., Mr., Prof. Suffix Jr., Sr., I, II, III

Patient ID

Date of Birth

Age

Sex

Height

Weight

BP [mmHg]

BSA

Patient's last name. Patient's first name.

Patient's middle initial(s). Identification code for the patient. If an identification (ID) is not entered, then the system generates a unique identifier starting

with the system date and time. This ID code displays on the Image screen. If there is not enough space for the entire code to

display on the Image screen, a portion of the code is displayed followed by three dots (…). Patient's date of birth using the date format selected in the system presets. When you enter or change this value, the system calculates and displays values for Age. The system automatically calculates and displays the patient's age based on the

Date of Birth, if entered. Patient's sex. If Male or Female is not selected, then the system selects Unknown. Patient's height using the measurement system selected in the system presets:

Metric or U.S. Patient's weight using the measurement system selected in the system presets:

Metric or U.S. Patient's blood pressure. Patient Body Surface Area in m

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)

For height in feet/inches and weight in pounds:

BSA = 0.007184 x (weight x 0.454)

. The system automatically calculates the BSA (based on

0.425

x (height)

0.725

0.425

x (height x 2.54)

0.725

4 - 6 INSTRUCTIONS FOR USE

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4 Examination Fundamentals

Patient — e-entry

Note: To move the cursor, press the Tab key on the keyboard. To confirm your entries, press the SET key on the control panel. Or, press the 2D control.

OB, Early OB, Fetal Echo and EM Exams

Note: The EDC and gestational age display at the top of the screen during imaging. These values

also display in the patient report.

In this field: Enter the…

Name Age Fetal age in weeks (w) and days (d).

LMP

EDC

Other Exams

Identification code for the patient. If an identification (ID) is not entered, then the system generates a unique identifier

starting with the system date and time. Patient's last and first name.

The system automatically calculates and displays the fetal age in weeks and days if a value already exists for LMP.

Start date of the patient's Last Menstrual Period (LMP) using the date format displayed on the screen.

When you enter or change this value, the system calculates and displays values for Age and EDC.

Estimated Date of Confinement (EDC) using the date format displayed on the screen. The system automatically calculates and displays the Estimated Date of Confinement

(EDC) if a value already exists for LMP and/or Age. When you enter or change this value, the system calculates and displays values for

LMP and Age.

In this field: Enter the…

Identification code for the patient. If an identification (ID) is not entered, then the system generates a unique identifier

starting with the system date and time.

Name

Birth

Patient's last and first name. Patient's date of birth using the date format displayed on the screen. When you enter or change this value, the system calculates and displays values

for Age.

Age

The system automatically calculates and displays the patient's age based on the

Date of Birth, if entered.

Sex

Patient's sex. If Male or Female is not selected, then the system selects Unknown. To select the sex, press the right or left arrow key on the keyboard.

History (All Examinations)

In this field: Enter...

Additional Info

Additional information.

INSTRUCTIONS FOR USE 4 - 7

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4 Examination Fundamentals

History (OB, Early OB, GYN, Fetal Echo, or EM) — Original Method

See also: Obstetrical Measurements and Calculations, Chapter B2, Features and Applications

Reference

History

In this field: Enter… OB

Date LMP/IVF

Select either LMP or IVF. For the LMP, enter the start date of the patient’s

Last Menstrual Period (LMP) using the date format selected in the system presets.

For IVF, enter the date of in-vitro fertilization using the date format selected in the system presets.

When you enter or change this value, the system calculates and displays values for Age[wks/days] and EDC.

The system automatically enters the year when you enter the month and day (if a compatible

Date Format option [Day/Month/Year or Month/Day/Year] is selected in the system presets).

EDC

The system automatically calculates and displays the Estimated Date of Confinement (EDC) if a value already exists for Date LMP/IVF and/or Age[wks/days].

Enter the Estimated Date of Confinement (EDC) using the date format selected in the system presets.

When you change a value (other than zero) for EDC, the system recalculates and displays values for

Date LMP/IVF and Age[wks/days].

Age[wks/days]

The system automatically calculates and displays the fetal age in weeks and days if a value already exists for Date LMP/IVF.

Enter the fetal age in weeks and days. When you enter or change this value, the system

calculates and displays values for Date LMP/IVF and EDC.

The system automatically calculates the EDC, but not the Date LMP/IVF, when you enter only the fetal age. If you enter the Date LMP/IVF and then change the fetal age, the system recalculates both the

Date LMP/IVF and EDC according to the fetal age.

Gravida Para Aborta Ectopics

Patient's history of pregnancies. The entries in these fields are transferred to the

Patient Report, but do not display on the Image screen.

Early

9 9 9 9 9

9 9

9 9 9 9 9

Gyn

Fetal Echo

9 9

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4 Examination Fundamentals

History (C-Vascular, P-Vascular, and Venous)

History

In this field: Enter…

BP(Left)

Blood pressure of the left arm, using the systole over

C-Vascular P-Vascular Venous

9 9 9

diastole measurement in mmHg.

BP(Right)

Blood pressure of the right arm, using the systole

9 9 9

over diastole measurement in mmHg.

ABI [Left/Right]

Ankle Brachial Index.

History (Urology)

In this field: Enter… PSA (ng/ml)

Prostate specific antigen level.

Institution

Use the system presets to display physician identification on the patient report.

M & R Configuration 1 > Measurement and Report Preset > Display Item

In this field: Enter the…

Referring MD

Performing MD

Sonographer

Identifying information for the referring physician. Identifying information for the performing physician. Identifying information for the sonographer.

Exam

Field: Description:

Transducer

Exam

Accession No

Lists the available transducers. Lists the exam types available for the selected transducer. 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.

Indication

Information describing the symptom or particular circumstance that indicates the advisability or necessity of a specific medical procedure.

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.

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4 Examination Fundamentals

Searching the Worklist

You can use the Worklist search function to select a scheduled procedure for a new study.

DICOM > Worklist Server > Streamlined Search

To search the Worklist server and begin a scheduled procedure:

1. Press the NEW PATIENT key on the control panel.

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 located at the upper left side of the form.

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.

3. If streamlined search is not enabled, you must first select the Search button before entering additional search criteria.

a. Enter additional search criteria using the keyboard.

 To access the next field, press the Tab key on the keyboard.  To remove data from all fields, select Clear.

b. Select Search to begin the search.

Note: 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.

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. 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 Number, DOB/Age, Sex.

4 - 10 INSTRUCTIONS FOR USE

Siemens X300 Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

About the User and Reference Manuals

Conventions

1 Introduction

System Overview

System Review

Intended Use

Transducers and Intended Applications

Image Screen Layout

Screen Saver

Sample Image Screen

Status Bar

QuickSets

2 Safety and Care

Operating Safety and Environment

System Symbols

Labels

Biohazard Considerations

Note on Fetal Examinations

Acoustic Output — Mechanical and Thermal Indices

Mechanical and Thermal Indices

Transmit Power Control

Transmit Power Display

Imaging Functions that Change Acoustic Output

Transducer Surface Temperature Limits

Electrical Safety

Level of Protection Against Electrical Shock — Transducers

Defibrillators

Pacemakers

Possible Combinations with Other Equipment

Ultrasound System — Care

Daily Checklist

Maintenance

Repair

Siemens Authorized Care

Cleaning and Disinfecting

Cleaning and Disinfecting the System

Cleaning an Air Filter

Caring for the Battery Pack

Battery Pack Location

Battery Pack Replacement and Disposal

Battery Pack Disposal

Documentation and Storage Devices — Care

Transducers — Care

Cleaning and Disinfecting Transducers

IPX8 Immersion Levels

Approved List of Pre-Cleaners and Low-Level Disinfectants

Approved List of Disinfectants

Sterilizing Transducers — VF13-5SP

Storage

Repair

Protective case

Transducer Accessories — Care

Transducer Sheaths

Storage

Gel Pad

Storage

Needle Guide Bracket Kits

Storage and Transportation

Cleaning, Disinfecting, and Sterilizing — Needle Guide Bracket Kits

Universal Needle Guide, Stainless

Storage

Product Recycling and Disposal

3 System Setup

Initial Setup

Moving the System

Swivel Locking Brake

Front Swivel Locking Brake

Back Swivel Locking Brake

Prior to the Move

During the Move

Shipping the System

After the Move

System Startup

Plugging in the System

Supplying Power to the System