Basic User Manual
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LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
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 LOGIQ200 PRO Series. It applies to all version of the 3.1X software for the LOGIQ200 PRO Series.
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 Ultrasound Europe: Tel: +49(0)212 2802 0 Kranzbühler GmbH & Co KG Beethovenstraße 239, Postfach 110560, D–42655 Solingen GERMANY
Revision History
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DATE
REASON FOR CHANGE
0
August 1, 1999
Initial Release
1
January 15, 2000
Software Version 3.02 Release
2
June 15, 2000
Software Version 3.15 Release
3
November 21, 2000
Software Version 3.16 Release
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LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
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Revision History
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LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Revision History 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.
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
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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 Safety chapter of this manual. European registered place of business:
GE Medical Systems Europe Quality Assurance Manager BP 34 F 78533 BUC CEDEX France Tel: +33 (0)1 30 70 40 40
.
For USA Only
S
Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).
S
Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory.
S
Canadian Standards Association (CSA).
S
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
General Electric Medical Systems is ISO 9001 and EN 46001 certified.
S
The original document was written in English.
LOGIQt200 PRO Series Basic Users Manual 2234813–100 Rev 1
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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.
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LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Table of Contents
Table of Contents Front Matter Title Page Revision History...
A
Regulatory Requirements... Table of Contents...
Regulatory Req 1 Table of Contents 1
Chapter 1 – Introduction System Overview... Attention... Prescription Device... System Components... Documentation... Introduction... General Indications for Use... Contraindications...
Who to Contact... Who To Contact...
How This Book is Organized... Manual Content... Manual Format...
1–2 1–2 1–2 1–2 1–3 1–4 1–5 1–5
1–6 1–6
1–9 1–9 1–11
Chapter 2 – Safety Safety Precautions... Icon Description... Hazard Symbols... Patient Safety... Equipment and Personnel Safety... Related Hazards... Device Labels... Acoustic Output... Controls Affecting Output... Warning Label Locations...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
2–2 2–2 2–3 2–4 2–6 2–6 2–8 2–16 2–16 2–18
1
Table of Contents Chapter 3 – Preparing the System for Use Site Requirements... Introduction... Before the system arrives... Environmental Requirements...
Console Overview... Console graphics... Storage areas... Peripheral/Accessory Connector Panel... Foot Switch (option)...
System Positioning/Transporting... Moving the System... Transporting the System... Wheels...
Powering On the System... Connecting and Using the System... Power Up Sequence...
Adjusting the Display Monitor... Rotate, tilt, raise and lower the monitor... Brightness and Contrast...
Probes... Introduction... Connecting the Probe... Activating the Probe... Storing the Probe... Deactivating the Probe...
Operator Controls... Control Panel Map... Preset Keys... Measurement and Annotation... Mode, Display and Record... Keyboard... Special Key Function...
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3–2 3–2 3–3 3–4
3–5 3–5 3–7 3–8 3–10
3–11 3–11 3–13 3–14
3–15 3–15 3–17
3–18 3–18 3–19
3–21 3–21 3–21 3–23 3–23 3–24
3–25 3–25 3–26 3–27 3–29 3–31 3–32
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Table of Contents Chapter 4 – Preparing for an Exam Beginning an Exam... Introduction... Beginning a New Patient... OB/GYN Exam Category... ID/Name...
4–2 4–2 4–2 4–6 4–6
Chapter 5 – Modes B–Mode... Introduction... Optimizing the Image...
M-Mode... Introduction... M-Mode Display... Optimizing the Timeline...
Mixed Mode Display Formats...
5–2 5–2 5–6
5–17 5–17 5–17 5–18
5–23
Chapter 6 – Scanning/Display Functions Zooming an Image... Introduction... Zooming an Image...
Freezing an Image... Introduction... Foot Switch option...
Using Cine... Introduction... Accessing Cine... Cine Gauge... Exiting Cine...
Annotating an Image... Introduction... Annotation Library... Adding Comments to an Image... Special Annotation Keys... Editing Annotations... Body Patterns...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
6–2 6–2 6–2
6–6 6–6 6–6
6–7 6–7 6–8 6–8 6–8
6–9 6–9 6–11 6–12 6–13 6–14 6–15
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Table of Contents Chapter 7 – General Measurements and Calculations Introduction... Overview... General Instructions... Erasing Measurements... Locating measurement controls... Measurement Key... Cursors...
B-Mode Measurements... Distance Measurement... Circumference/Area (Ellipse) Measurement... Circumference/Area (Trace) Measurement... Echo Level Measurement...
M-Mode Measurements... Overview... Tissue depth... Time... Slope...
7–2 7–2 7–2 7–3 7–4 7–5 7–5
7–6 7–6 7–8 7–10 7–12
7–13 7–13 7–14 7–15 7–16
Chapter 8 – Abdomen and Small Parts General Calculations... Overview... Measuring Volume... Measuring Angle... Measuring Stenosis Area Ratio (% stenosis)... Echo Level Histogram... Measuring heart rate (HR)... Helpful hints... General Calculation Formulas...
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8–2 8–2 8–5 8–8 8–9 8–15 8–17 8–19 8–19
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Table of Contents Chapter 9 – OB/GYN Exam Preparation... Overview...
OB Measurements and Formulas... Introduction... OB Format Selection... OB Measurement Menus and Formulas...
OB Summary Reports... Overview... Starting an Exam... Formulas... Editing the OB Summary Report... Gestational Age Error Markers... OB Report Layout... Measurement Averaging Page Layout... OB Anatomical Survey Page Layout... OB Trend Graph Page Layout... OB Trend Graph Labeling... Changing OB Trend Graph Selection... Input Previous Data Page Layout...
Fetal Trend Management... Overview... Storing Patient Information... Growth Trending... Patient List Management...
MGOB–Multigestational... Overview... Patient Entry Menu... Distinguishing Each Fetus... Measurements/Calculations... Change the Number of Fetuses... Report Page Layout... OB Graph...
GYN Measurements... B-Mode...
GYN Summary Report... Overview... GYN Report Layout... GYN Calculation Formulas... Measurement Averaging Page Layout... IVF Report Page Layout...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
9–3 9–3
9–4 9–4 9–4 9–4
9–17 9–17 9–19 9–20 9–21 9–22 9–23 9–27 9–29 9–30 9–31 9–33 9–34
9–36 9–36 9–36 9–41 9–42
9–47 9–47 9–47 9–48 9–48 9–49 9–50 9–52
9–54 9–54
9–60 9–60 9–62 9–63 9–64 9–65
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Table of Contents Chapter 10 – Cardiology Introduction... Overview... Cardiology Calculations Measurement Menus... General Guidelines... Auto Sequence Measurement... BSA Calculation Methods...
LV Analysis Measurements... Cubed, Teichholz, Gibson Methods... Cubed Method Formulas... Teichholz Method Formulas... Gibson Method Formulas... Bullet and Modified Simpson’s Rule Methods... Bullet Method Formulas... Modified Simpson’s Rule Method Formulas... Single Plane Ellipsoid Methods... Bi Plane Ellipsoid Methods... Single Plane Ellipsoid Method Formulas... Bi Plane Ellipsoid Method Formulas...
M–Mode Analysis Measurement...
10–2 10–2 10–5 10–6 10–6 10–7
10–8 10–8 10–9 10–10 10–11 10–12 10–13 10–14 10–15 10–15 10–16 10–17
10–18
Overview... 10–18 M-Mode Analysis – Left/Right Ventricle (M-LV/RV)... 10–19 M-Mode Analysis – Left/Right Ventricle (M-LV/RV) Formulas... 10–20 M-Mode Analysis – Mitral Valve (M-MV)... 10–22 M-Mode Analysis – Mitral Valve (M-MV) Formulas... 10–23 M-Mode Analysis – Aortic Valve (M-AV)... 10–24 M-Mode Analysis – Aortic Valve (M-AV) Formulas... 10–25 M-Mode Analysis – Pulmonic Valve (M-PV)... 10–26 M-Mode Analysis – Pulmonic Valve (M-PV) Formulas . . 10–27 M-Mode Analysis – Tricuspid Valve (M-TV)... 10–28 M-Mode Analysis – Tricuspid Valve (M-TV) Formulas . . 10–29
Additional Cardiology Calculations...
10–30
ECG Option...
10–31
Overview... ECG Lead Placement... ECG Default Preset... ECG Controls...
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10–31 10–32 10–33 10–33
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Table of Contents Chapter 11 – Urology Urology Calculations... Overview... Urology Summary Report Page...
Using the Transaxial Probe... Transaxial Probe Preparation... Use of Transaxial Probe with Volume Stepper Device . .
Stepper Volume Calculation... Stepper Volume Formula... Description... Prerequisite... Area Measurement for Each Slice (Step Increment) . . .
11–2 11–2 11–2
11–8 11–8 11–9
11–13 11–13 11–14 11–14 11–16
Chapter 12 – Recording Images Archiving Images... Image Memory... Recall... Helpful hints... Peripheral Devices... Black /White Video Page Printer Operations... Multi-Image Camera (MIC) (IIE Model 460)... Video cassette recorder (VCR)... MOD Image Archive (option)...
12–2 12–2 12–4 12–4 12–5 12–6 12–8 12–9 12–10
Chapter 13 – Customizing Your System Introduction... Overview... Setup Menu Command Lines... Basic Operation...
Menu Structure... General System 1 Setup (page 1 of 11)... General System 2 Setup (page 2 of 11)... Probe Parameter 1 Setup (page 3 of 11)... Probe Parameter 2 Setup (page 4 of 11)... Image Display & Application Setup (page 5 of 11)... Body Pattern Setup (page 6 of 11)... Comment Setup (page 7 of 11)... Measurement Setup (page 8 of 11)... Patient Entry Setup (page 9 of 11)... User Define Category and Key Setup (page 10 of 11) . . User Utility (page 11 of 11)...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
13–2 13–2 13–3 13–5
13–8 13–8 13–12 13–19 13–22 13–24 13–28 13–31 13–32 13–45 13–47 13–48
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Table of Contents Chapter 14 – Probes and Biopsy Probe Overview... Ergonomics... Applications... Specifications... Connecting and Disconnecting a Probe... Care and Maintenance... Probe Safety... Probe handling and infection control... Coupling gels... Planned Maintenance...
Probe Discussion... Introduction... Curved Array (Convex) Probes... Linear Array Probes... Sector Array Probes...
Biopsy Special Concerns... Precautions Concerning the Use of Biopsy Procedures
Guidezones... Biopsy Procedure... Needle Guide Type Selection... Biopsy Guide Attachment... MTZ Probe Biopsy Guide... Biopsy Probes...
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14–2 14–2 14–5 14–6 14–7 14–8 14–9 14–11 14–17 14–17
14–18 14–18 14–19 14–22 14–24
14–25 14–25
14–27 14–27 14–28 14–30 14–33 14–36
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Table of Contents Chapter 15 – User Maintenance System Data... Specifications... LOGIQ 200 PRO Series Clinical Measurement Accuracy LOGIQ 200 PRO Series Clinical Calculation Accuracy .
Warranties... Scope and Duration of Warranties... Warranty Exclusions... Exclusive Warranty Remedies...
System Care and Maintenance... Overview... Inspecting the System... Weekly Maintenance... Planned Maintenance...
Troubleshooting... Introduction... Loose cables... Display Messages... System Error Message Description... Operation Error Message Description... Operation Guide Message Description...
Assistance... Clinical Questions... Service Questions... Literature... Accessories... Supplies/Accessories...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
15–2 15–2 15–4 15–6
15–7 15–7 15–9 15–10
15–11 15–11 15–11 15–12 15–16
15–17 15–17 15–17 15–18 15–19 15–20 15–21
15–22 15–22 15–22 15–22 15–22 15–23
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Table of Contents Chapter 16 – Acoustic Output Bioeffects... Concerns Surrounding the Use of Diagnostic Ultrasound Operator Awareness and Actions to Minimize Bioeffect Implementing ALARA Methods... Training and User Assistance...
IEC Acoustic Output Tables... IEC Acoustic Output Tables...
16–2 16–2 16–5 16–8 16–9
16–10 16–10
Index
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LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
Introduction
Introduction Introduction System Overview... Attention... Prescription Device... System Components... Documentation... Introduction... General Indications for Use... Contraindications...
Who to Contact... Who To Contact...
How This Book is Organized... Manual Content... Manual Format...
LOGIQ200 PRO Series Basic Users Manual 2234813–100 Rev 1
1–2 1–2 1–2 1–2 1–3 1–4 1–5 1–5
1–6 1–6
1–9 1–9 1–11
1
System Overview
System Overview Attention This manual contains enough information to operate the system safely. Advanced equipment training will 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 LOGIQt200 PRO Series system. Keep this User’s Manual with the equipment at all times. Periodically review the procedures for operation and safety precautions.
Prescription Device
.
For USA Only
Caution: United States law restricts this device to sale or use by or on the order of a physician.
System Components
.
2
Refer to the Service Manual (2235374) for the LOGIQt200 PRO Series system components.
LOGIQt200 PRO Series Basic Users Manual 2234813–100 Rev 1
System Overview Documentation LOGIQt200 PRO Series 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 LOGIQt200 PRO Series. 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 LOGIQt200 PRO Series manuals are written for users who are familiar with basic ultrasound principals and techniques. They do not include sonography training or clinical procedures.
LOGIQt200 PRO Series Basic Users Manual 2234813–100 Rev 1
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