LOGIQ 400 Basic User Manual Rev 0

Regulatory Requirement

This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices

This manual is a reference for the LOGIQ 400MD MR3 and the LOGIQ 400CL. It applies to all versions of 4.01 software for the LOGIQ 400 and 4.02 software for the LOGIQ 400CL.

GE Medical Systems GE Medical Systems: Telex 3797371 P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Medical Systems Ċ Europe: Tel: +49 (0) 212 28 02 208 Beethovenstraße 239, Postfach 11 05 60, D-42655 Solingen GERMANY

Revision History

Revision History REV

DATE

REASON FOR CHANGE

0

April 16, 1999

Initial Release

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LIST OF EFFECTIVE PAGES REVISION NUMBER

Title Page Revision History A and B Regulatory Requirements 1 and 2 Table of Contents 1 thru 12 1-1 thru 1-14 2-1 thru 2-24 3-1 thru 3-42 4-1 thru 4-8 5-1 thru 5-74 6-1 thru 6-28 7-1 thru 7-22

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PAGE NUMBER

REVISION NUMBER

8-1 thru 8-12 9-1 thru 9-46 10-1 thru 10-38 11-1 thru 11-10 12-1 and 12-4 13-1 thru 13-30 14-1 thru 14-104 15-1 thru 15-48 16-1 thru 16-44 Index 1 thru 24

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Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on GPC (GE Medical Systems Global Product Configuration). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1-800-682-5327 or 414-524-5698.

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Revision History A

Revision History This page left blank intentionally.

Revision History B

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Regulatory Requirements

Regulatory Requirements This product complies with the regulatory requirements of the following:

S

Council Directive 93/42/EEC concerning medical devices: the label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown on 2–23 of this manual. European registered place of business:

S S

.

S S For USA Only

GE Medical Systems Europe Quality Assurance Manager BP 34 F 78533 BUC CEDEX France Tel: +33 (0)1 30 70 40 40 Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory. Canadian Standards Association (CSA). International Electrotechnical Commission (IEC), international standards organizations, when applicable.

Caution: United States law restricts this device to sale or use by or on the order of a physician.

S S

General Electric Medical Systems is ISO 9001 and EN 46001 certified. The original document was written in English.

LOGIQ  400 Basic User Manual 2233660–100 Rev. 0

Regulatory Req 1

Regulatory Requirements NOTE: This equipment generates, uses and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emissions limits for a Group 1, Class A Medical Devices Directive as stated in EN 60601–1–2. However, there is no guarantee that interference will not occur in a particular installation. NOTE: If this equipment is found to cause interference (which may be determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s): –

reorient or relocate the affected device(s)

–

increase the separation between the equipment and the affected device

–

power the equipment from a source different from that of the affected device

–

consult the point of purchase or service representative for further suggestions

NOTE: The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users’ authority to operate the equipment. NOTE: To comply with the regulations on electromagnetic interference for a Class A FCC Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the FCC regulations. NOTE: Do not use devices which intentionally transmit RF Signals (cellular phones, transceivers, or radio controlled products) in the vicinity of the equipment as it may cause performance outside the published specifications. Keep the power to these type devices turned off when near this equipment. The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who may be around this equipment to fully comply with the above requirement.

Regulatory Req 2

LOGIQ  400 Basic Users Manual 2233660–100 Rev. 0

Table of Contents

Table of Contents VOLUME 1 Front Matter Title Page Revision History... A Regulatory Req 1 Regulatory Requirements... Table of Contents... Table of Contents 1

Chapter 1-Introduction System Overview...

1–2

Attention... Documentation... Physical Principle Used... General Indications for Use... Contraindications... Prescription Device... LOGIQ 400/LOGIQ 400CL Functionality...

1–2 1–2 1–3 1–4 1–5 1–5 1–6

Who To Contact...

1–7

Contacting GE Medical Systems-Ultrasound... Manufacturer...

1–7 1–10

How This Book is Organized...

1–11

Manual Content... Manual Format...

1–11 1–13

Chapter 2-Safety Safety Precautions...

2–2

Precaution Levels... Hazard Symbols... Patient Safety... Equipment and Personnel Safety... Device Labels... Acoustic Output... Warning Label Locations...

2–2 2–3 2–4 2–6 2–8 2–16 2–18

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Table of Contents 1

Table of Contents Chapter 3-Preparing the System for Use Site Requirements...

3–2

Introduction... Before the system arrives... Environmental Requirements...

3–2 3–3 3–4

Console Overview...

3–5

Console graphics... Peripheral/Accessory Connection...

3–5 3–8

System Positioning/Transporting...

3–11

Moving the System... Transporting the System... Wheels...

3–11 3–14 3–15

Powering On the System...

3–16

Connecting and Using the System...

3–16

Adjusting the Display Monitor...

3–23

Rotate, tilt, raise and lower the monitor... Brightness and Contrast... Speakers...

3–23 3–24 3–27

Probes...

3–28

Introduction... Connecting the Probe... Cable Handling... Activating the Probe... Deactivating the Probe... Disconnecting the Probe... Transporting Probes... Storing the Probe...

3–28 3–28 3–30 3–30 3–31 3–32 3–32 3–32

Operator Controls...

3–33

Control Panel Map... Key Illumination... Keyboard... Soft Menu Control Panel... Mode, Display and Record... Measurement and Annotation...

3–33 3–34 3–35 3–36 3–39 3–41

Table of Contents 2

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Table of Contents Chapter 4-Preparing for an Exam Beginning an Exam...

4–2

Introduction... Beginning a New Patient... ID/Name...

4–2 4–3 4–5

Exam Application Preset Selection...

4–7

Introduction... Selecting a probe...

4–7 4–7

Chapter 5-Modes B-Mode...

5–2

Introduction... B-Mode Key Operation... Reading the B-Mode Display... Optimizing the Image...

5–2 5–2 5–3 5–9

Adding Color...

5–25

Introduction... Activating Color Flow... Reading the Color Flow Display... Optimizing the Color Flow Image... Power Doppler Imaging (option)...

5–25 5–25 5–26 5–27 5–41

Doppler...

5–42

Introduction... Pulsed Wave Doppler... Continuous Wave Doppler... Reading the Doppler Display... Activating Doppler Mode... Doppler Optimization...

5–42 5–43 5–44 5–45 5–47 5–48

M-Mode...

5–62

Introduction... Reading the M-Mode or Doppler Spectrum Only Display... Reading the Dual Doppler Spectrum Only Display... Optimizing the Timeline...

5–62 5–62 5–63 5–64

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Table of Contents 3

Table of Contents 3DvieW Mode (Option)...

5–70

Overview...

5–70

Mixed Mode Display Formats...

5–71

Display Formats...

5–71

Chapter 6-Scanning/Display Functions Zooming an Image...

6–2

Introduction... Zoom Methods... Zooming an M-Mode Image... Multi–Image Zoom...

6–2 6–2 6–4 6–5

Freezing an Image...

6–6

Introduction... Freezing an Image (Freeze Key)... Freezing an Image (Foot Switch option)...

6–6 6–7 6–7

Using Cine...

6–8

Introduction... Accessing Cine... Using Cine Loop... Cine Loop Speed... Multipl CINE... Side Change... CINE Gauge... CINE Capture (option)... Exiting Cine... Helpful Hints... ECG/Cine Gauge/Image Tracking...

6–8 6–10 6–11 6–13 6–13 6–14 6–14 6–14 6–15 6–15 6–15

Annotating an Image...

6–16

Introduction... Annotation Library... Adding Comments to an Image... Special Annotation Keys... Editing Annotations... Body Patterns...

6–16 6–19 6–21 6–22 6–23 6–24

Table of Contents 4

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Table of Contents Chapter 7-General Measurements and Calculations Introduction...

7–2

Overview... Measurement Controls... Cursors... General Mode Measurements Method... Measurement Key... General Instructions... Erasing Measurements...

7–2 7–3 7–4 7–4 7–5 7–6 7–6

Mode Measurements...

7–7

B-Mode Measurements... CFM B-Mode Measurements... Doppler Mode Measurements... M-Mode Measurements...

7–7 7–12 7–14 7–19

Chapter 8-Abdomen and Small Parts General Calculations...

8–2

Overview... Volume... Angle... Stenosis Ratio (% stenosis)... S/D Ratio, RI, A/B Ratio or PI... Heart Rate... Trace Auto... Max PG... Mean PG... Cardiac Output (CO)... Stroke Volume Ratio (SV)... Heart Rate (HR)... Flow Volume (FV)... Trace Auto... Flow Volume Output (FVO)... Helpful hints... Hip Dysplasia Measurement... General Calculation Formulas...

8–2 8–2 8–3 8–3 8–3 8–3 8–3 8–3 8–3 8–4 8–5 8–6 8–7 8–8 8–8 8–8 8–9 8–11

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Table of Contents 5

Table of Contents Chapter 9-OB/GYN (Basic OB software option) Exam Preparation...

9–2

Overview...

9–2

Fetal Doppler...

9–3

Doppler Mode for Fetal Exams...

9–3

Acoustic Output...

9–4

Considerations...

9–4

OB Measurements and Formulas...

9–5

Introduction... OB Format Selection... OB Measurement Soft Menus and Formulas... Helpful Hints...

9–5 9–5 9–6 9–24

OB Summary Reports...

9–25

Starting an Exam... OB Report Page Layout... Editing the Report... Recording Summary Reports...

9–25 9–26 9–33 9–35

Anatomical Survey...

9–36

Overview... Editing... User Programmed Features...

9–36 9–37 9–37

OB Graphs...

9–38

Overview... OB Graph Selection...

9–38 9–39

Advanced Obstetrical Options...

9–41

Options...

9–41

GYN Measurements...

9–42

B-Mode... Doppler Mode...

9–42 9–43

GYN Summary Report...

9–45

GYN Report Layout... GYN Calculation Formulas...

9–45 9–46

Table of Contents 6

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Table of Contents Chapter 10-Cardiology (software option) Introduction...

10–3

Overview... Report Pages... BSA Calculation Methods... Measuring Heart Rate (HR)...

10–3 10–5 10–6 10–6

LV Measurement Methods...

10–7

Cubed Method... Teichholz Method... Bullet Method... Modified Simpson’s Rule Method... Single Plane Ellipsoid Method... Bi Plane Ellipsoid Methods...

10–7 10–9 10–11 10–13 10–15 10–17

Additional Cardiology Calculations...

10–19

Volume... Angle... % Stenosis (stenosis ratio)... PHT (Pressure Half Time)... MVA (Mitral Valve Area)... ET (Ejection Time)... Max PG... Mean PG... Trace Auto... S/D (D/S) Ratio, RI, A/B Ratio or PI... Heart Rate (HR)... Transf Calcs...

10–19 10–22 10–23 10–24 10–24 10–25 10–26 10–27 10–28 10–29 10–30 10–30

ECG Option...

10–31

Overview... Physio Sweep Speed... ECG Sub-Menu... ECG Lead Placement... ECG Sync Mark Display... ECG Sub-Menu Page 1... ECG Gain Pages 2 and 3... ECG/Cine Gauge/Image Tracking...

10–31 10–32 10–32 10–33 10–33 10–34 10–36 10–36

Advanced Cardiac Calculations (AMCAL option)...

10–37

Overview...

10–37

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Table of Contents 7

Table of Contents Chapter 11-Vascular (software option) Exam Preparation...

11–2

Introduction... General Guidelines...

11–2 11–2

Measurements...

11–3

Carotid Artery Measurements... Heart Rate (HR)... Trace Auto...

11–3 11–5 11–5

Vascular Summary Report...

11–6

Introduction... Displaying the Summary Report... Editing the Summary Report... Recording Summary Reports... Vascular Calculation Formulas...

11–6 11–6 11–7 11–8 11–9

Advanced Vascular (software option)...

11–10

Overview... Menu Selections...

11–10 11–10

Chapter 12-Urology Urology Basic Calculations...

12–2

Overview... Presumed Circle Area Ratio (PCAR)... Stepper Volume (STVOL)...

12–2 12–3 12–3

Chapter 13-Recording Images Recording Images...

13–2

Image Memory... Recall... Helpful hints... Peripheral Devices... Video Signal Specifications... Maintenance... MOD Image Archive (option)...

13–2 13–4 13–4 13–5 13–16 13–16 13–17

Advanced Recording Option (software option)...

13–29

DICOM...

13–29

Table of Contents 8

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Table of Contents Chapter 14-Customizing Your System Time Adjustment...

14–3

Overview... Time Adjustment...

14–3 14–3

Preset Parameters...

14–5

Overview...

14–5

Custom Display...

14–7

Overview... Parameter Menu Command Lines... Changing a Parameter Value... Custom Display Contents... Page 1 of 18 (Imaging Parameter 1 – Probe Dependent 1)... Page 2 of 18 (Imaging Parameter 2 – Probe Dependent 2)... Page 3 of 18 (Imaging Parameter 3 – Probe Dependent 3)... Page 4 of 18 (Imaging Parameter 4 – Probe Dependent 4)... Page 5 of 18 (Imaging Parameter 5 – Probe Dependent 5)... Page 6 of 18 (Imaging Parameter 6 – Probe Dependent 6)... Page 7 of 18 (Imaging Parameter 7 – Probe Dependent 7)... Page 8 of 18 (Imaging Parameter 8 – Probe Dependent 8)... Page 9 of 18 (Imaging Parameter 9)... Page 10 of 18 (Imaging Parameter 10)... Page 11 of 18 (Imaging Parameter 11)... Page 12 of 18 (Imaging Parameter 12)... Page 13 of 18 (Imaging Parameter 13)... Page 14 of 18 (Imaging Parameter 14)... Page 15 of 18 (Imaging Parameter 15)... Page 16 of 18 (Imaging Parameter 16)... Page 17 of 18 (Imaging Parameter 17)... Page 18 of 18 (Imaging Parameter 18)...

14–7 14–8 14–10 14–12 14–13 14–15 14–18 14–20 14–22 14–23 14–25 14–26 14–28 14–29 14–31 14–32 14–34 14–37 14–39 14–41 14–42 14–44

System Parameters...

14–46

Overview... System Parameters Contents... Page 1 of 7 (System Setup)... Page 2 of 7 (System Setup)... Page 3 of 7 (System Setup)... Page 4 of 7 (System Setup – Body Pattern)... Page 5 of 7 (System Setup – Recording)... Page 6 of 7 (System Setup – User ID and Password)... Page 7 of 7 (DICOM)...

14–46 14–47 14–48 14–50 14–53 14–54 14–58 14–60 14–62

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Table of Contents 9

Table of Contents Preset Program...

14–63

Overview... Preset Program Contents... Page 1 of 10 (Application)... Page 2 of 10 (Application)... Page 3 of 10 (Application – Measurement)... Page 4 of 10 (Application – Measurement)... Page 5 & 6 of 10 (Application – Measurement Sub-Menu)... Page 7 of 10 (Application – Measurement Submenu)... Page 8 & 9 of 10 (Application – Annotation Library)... Page 10 of 10 (Application – Patient Information)...

14–63 14–64 14–65 14–66 14–67 14–70 14–72 14–72 14–89 14–89

Save Values...

14–90

Overview... Saving Scan Values...

14–90 14–90

Exam Applications Presets...

14–92

Overview... Defining a User Preset... Naming a User Preset... Deleting User Presets and Names... Recall Preset...

14–92 14–92 14–95 14–96 14–96

User Define Function...

14–97

Overview... Programming the User Define Function... User Define Key Program Example... User Define Names & Lock/Unlock... Deleting User Define Functions... Saving User Define Functions...

14–97 14–97 14–99 14–100 14–102 14–102

User Data Back-up...

14–103

Overview... Saving Presets... Loading Presets...

14–103 14–103 14–104

Table of Contents 10

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Table of Contents Chapter 15-Probes and Biopsy Probe Overview...

15–2

Labeling... Applications... Specifications... Probe Usage... Care and Maintenance... Probe Safety... Probe handling and infection control... Coupling gels... Planned Maintenance...

15–2 15–5 15–6 15–9 15–9 15–10 15–12 15–18 15–18

Probe Discussion...

15–19

Introduction... Curved Array (Convex) Probes... Linear Array Probes... Sector Probes... CWD Probes...

15–19 15–20 15–23 15–26 15–28

Biopsy Special Concerns...

15–29

Precautions Concerning the Use of Biopsy Procedures...

15–29

Preparing for a Biopsy...

15–30

Displaying the Guidezone... Determining Needle Length... Needle Guide Type Preset Selection... Preparing the Biopsy Guide Attachment... E721 Probe Biopsy Guide... Biopsy Probes...

15–30 15–31 15–32 15–35 15–43 15–47

Chapter 16-User Maintenance System Data...

16–3

Specifications... LOGIQ 400 Clinical Measurement Accuracy... LOGIQ 400 Clinical Calculation Accuracy...

16–3 16–5 16–6

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Table of Contents 11

Table of Contents Warranties...

16–7

Scope and Duration of Warranties... Warranty Exclusions... Exclusive Warranty Remedies...

16–7 16–9 16–10

System Care and Maintenance...

16–11

Overview... Inspecting the System... Weekly Maintenance... Other Maintenance...

16–11 16–11 16–12 16–16

Troubleshooting...

16–19

Introduction... Trouble images... Loose cables... Display Messages... System Error Message Description... Operation Error Message Description... Operation Guide Message Description... Warning Message Description...

16–19 16–19 16–25 16–26 16–27 16–28 16–32 16–33

Operator Diagnostics...

16–34

Introduction... Probe Selection... Accessing Diagnostics... System Test 1 (reduced)... Test Pattern Black & White... Test Pattern Color... Test Pattern Graphics...

16–34 16–34 16–35 16–36 16–37 16–38 16–38

Assistance...

16–39

Clinical Questions... Service Questions... Literature... Accessories... Supplies/Accessories...

16–39 16–39 16–39 16–39 16–40

Index...

Index 1

Table of Contents 12

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System Overview

System Overview Attention This manual contains enough information to operate the system safely. Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed upon time period. Read and understand all instructions in this manual before attempting to use the LOGIQ 400 system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions.

Documentation LOGIQ 400 Documentation consists of three manuals: S

The Quick Start Guide (TRANSLATED) provides a step-by-step description of the basic features and operation of the LOGIQ 400. It is intended to be used in conjunction with the Basic User Manual in order to provide the information necessary to operate the system safely.

S

The Basic User Manual (TRANSLATED) provides information needed by the user to operate the system safely. It describes basic functions of the system, safety features, operating modes, basic measurements/ calculations, probes, user care and maintenance.

S

The Advanced Reference Manual (ENGLISH ONLY) is intended for the trained, professional user. It contains all the information found in the Quick Start Guide and Basic User Manual, as well as information on options, advanced customization techniques and data tables.

The LOGIQ 400 manuals are written for users who are familiar with basic ultrasound principals and techniques. They do not include sonography training or clinical procedures.

1–2

LOGIQ  400 Basic Users Manual 2233660–100 Rev. 0

System Overview Physical Principle Used The transmission and reception of mechanical high frequency waves through a transducer associated with a computer that creates the image in a digital memory, are used for the creation of medical ultrasound images. The spreading of mechanical ultrasound waves produces echoes when body changes density. In the case of human tissue, these echoes are created when the signal goes from an adipose tissue (fat) region to a muscular tissue region, among others. The echoes are returned through the same transducer that converts them back into electrical signals. These signals are highly amplified, processed by filters with several frequency and time response options, and finally scanned and stored in a digital memory. Once in the memory, the image can be displayed in real-time on a monitor. Several analog and digital circuits transform the electrical high frequency signals into a flow of digital signals, allowing the composition of the image in the memory. All the signal reception and transmission parameters are controlled by the main computer. Through the selection of these parameters by the operator, the system modifies the transmission and reception features allowing a wide range of uses, from obstetrics to peripheral vascular examinations. As its design is based on solid state components, the system is free from variations over time and requires very little maintenance. All the transducers are accurate solid state devices, allowing control of creation of images from convex, micro-convex and linear transducers. The use of a solid state design allows a wide range of sweep parameters that can be optimized resulting in a consistent creation of fine anatomical details with excellent penetration and dynamic contrast band in the tissue. The system features a sophisticated design, providing multiple functions of diagnostic and function setup keys. This makes the system user-friendly and easy to use.

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