GE LOGIQ E9 User manual

Technical Publications
Direction 5454884-100 English
Rev. 1
LOGIQ E9 User Guide
Version R4
Operating Documentation
Copyright 2012 By General Electric Co.
0459

Regulatory Requirement
LOGIQ E9 complies with regulatory requirements of the following European
Directive 93/42/EEC concerning medical devices.
This manual is a reference for the LOGIQ E9. It applies to Version R4 software for
the LOGIQ E9 ultrasound system.
0459
GE Healthcare
P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
(Asia, Pacific, Latin America, North America)
GE Ultraschall Deutschland GmbH & Co. KG
Beethovenstrasse 239
Postfach 11 05 60
D-42655 Solingen GERMANY
TEL: [phone]; FAX: [phone]

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Revision History
Reason for Change
List of Effective Pages
Please verify that you are using the latest revision of this document. Information
pertaining to this document is maintained on ePDM (GE Healthcare electronic Product
Data Management). 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 1 262 524 5698.
REV DATE
(YYYY/MM/DD) REASON FOR CHANGE
Rev. 1 2012/11/09 Initial Release
PAGE NUMBER REVISION
NUMBER PAGE NUMBER REVISION NUMBER
Title Page Rev. 1 Chapter 2 Rev. 1
Revision History Rev. 1 Chapter 3 Rev. 1
Regulatory Requirements Rev. 1 Chapter 4 Rev. 1
Table of Contents Rev. 1 Index Rev. 1
Chapter 1 Rev. 1

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Regulatory Requirements
Conformance Standards
The following classifications are in accordance with the IEC/
EN 60601-1:6.8.1:
• According to 93/42/EEC Medical Device Directive, this is
Class IIa Medical Device.
• According to IEC/EN 60601-1,
• Equipment is Class I, Type B with BF or CF Applied
Parts.
• According to CISPR 11,
• Equipment is Group 1, Class A ISM Equipment.
This product complies with the regulatory requirement of the
following:
• Council Directive 93/42/EEC concerning medical devices:
the CE label affixed to the product testifies compliance to
the Directive.
The location of the CE marking is shown in the Safety
chapter of this manual.
Authorized EU Representative
European registered place of business:
GE Medical Systems Information Technologies GmbH
(GEMS IT GmbH)
Munzinger Strasse 3, D-79111 Freiburg, GERMANY
Tel: [phone]; Fax: [phone]

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Conformance Standards (continued)
• International Electrotechnical Commission (IEC).
• IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1
General Requirements for Safety.
• IEC/EN 60601-1-1 Safety requirements for medical
electrical systems.
• IEC/EN 60601-1-2 Electromagnetic compatibility -
Requirements and tests.
• IEC/EN 60601-1-4 Programmable electrical medical
systems.
• IEC 60601-1-6 (Usability), EN 1041 (Information
supplied with medical devices)
• IEC 60601-2-37 Medical electrical equipment. Particular
requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment.
• International Organization of Standards (ISO)
• ISO 10993-1 Biological evaluation of medical devices.
• Underwriters’ Laboratories, Inc. (UL), an independent
testing laboratory.
• UL 60601-1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
• Canadian Standards Association (CSA).
• CSA 22.2, 601.1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
• NEMA/AIUM Acoustic Output Display Standard (NEMA
UD-3).
• Medical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).

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Certifications
• General Electric Medical Systems is ISO 9001 and
ISO 13485 certified.
Original Documentation
• The original document was written in English.
Country Specific Approval
• JAPAN
MHLW Certified Number: 220ABBZX00177000
• KOREA
KFDA License 09-180
• USA AND TERRITORIES
Importer Information
• Turkey
ITHALATÇI
PENTA ELEKTRONIK MEDIKAL
SISTEMLER SAN. VE TIC. A.S.
HOSDERE CAD. FUAR SOK. 5 / 3
Y. AYRANCI / ANKARA
DANGER
The following optional features ARE NOT available in the
USA and its territories:
– Elastography Quanitfication
– Contrast Enhanced Ultrasound
– Breast Measure Assistant
– OB Measure Assistant

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Table of Contents
Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3
Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5
Original Documentation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5
Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5
Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5
Table of Contents
Chapter 1 — Getting Started
Console Overview
Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Prescription Device- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3
Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4
Important Notices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5
Console Graphics- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Moving the System
Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18
When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20
Operator Panel Movement Controls - - - - - - - - - - - - - - - - - - - - - - - - - 1-21
Setting the front wheels lock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-23
System Start-Up
Power On- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-24
Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-25
Circuit breaker - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-27
Probes
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-28
Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-29
Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30
Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30
Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-31
Probe Discussion - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-31
Biopsy Special Concerns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-41
Preparing for a Biopsy- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-43
Surgery/Intra-operative Use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-64
Beginning an Exam
Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-66
Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-68
Chapter 2 — Performing an Exam
Optimizing the Image
B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

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Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5
M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7
M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7
Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
3D Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10
Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11
Measurement and Analysis
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16
Location of Measurement Controls- - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
B-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18
Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26
M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29
Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-31
Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-36
Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - - 2-39
Chapter 3 — After the Exam is Over
Probe Overview
Probe Naming Conventions- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
Probe handling and infection control- - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - - 3-4
Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16
System Presets
Foreign Language Keyboard Setup - - - - - - - - - - - - - - - - - - - - - - - - - 3-18
Data Backup
EZBackup and EZMove- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-25
Backup procedure: user-defined configurations - - - - - - - - - - - - - - - - - 3-32
Restore procedure: patient data- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33
Restore procedure: user-defined configurations- - - - - - - - - - - - - - - - - 3-34
Configuring Connectivity
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35
Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36
Anti-Virus Software Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37
Electronic Documentation
Accessing Documentation Via a Windows PC - - - - - - - - - - - - - - - - - - 3-39
Accessing Documentation on the Ultrasound Scanner Via the media- - 3-40
Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41
Contact Information
Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - 3-42
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48
System Data
Features/Specifications- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49
System Care and Maintenance
Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55
Inspecting the System- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-56
Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58
Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-63

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Assistance
Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66
Chapter 4 — Safety
Owner Responsibility
Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2
Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3
Safety Precautions
Precaution Levels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4
Hazard Symbols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5
Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7
Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-11
Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18
EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-19
Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31
Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33
Device Labels
Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-37
Warning Label Locations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-43
Index

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LOGIQ E9 – User Guide 1-1
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Chapter 1
Getting Started
Console Overview, Moving the System, System
Start-up, Probes and Beginning an Exam

Getting Started
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Console Overview
Attention
This manual contains necessary and sufficient 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 E9 system.
Keep this manual with the equipment at all times. Periodically
review the procedures for operation and safety precautions.
Disregarding information on safety is considered abnormal use.
Not all features or products described in this document may be
available or cleared for sale in all markets. Please contact your
local GE Healthcare Ultrasound representative to get the latest
information.
NOTE: Please note that orders are based on the individually agreed
upon specifications and may not contain all features listed in this
manual.
NOTE: All references to standards / regulations and their revisions are
valid at the time of publication of the user manual.
Prescription Device
CAUTION: United States law restricts this device to sale or use
by, or on the order of a physician.

Console Overview
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Indications for Use
The LOGIQ E9 is intended for use by a qualified physician for
ultrasound evaluation.
Frequency of Use
Daily (Typically 8 hours)
Operator Profile
• Qualified and trained physicians or sonographers with at
least basic ultrasound knowledge.
• The operator must have read and understood the user
manual.
Clinical Applications
Specific clinical applications and exam types include:
• Fetal/Obstetrics
• Abdominal (includes renal, GYN/Pelvic)
• Pediatric
• Small Organ (breast, testes, thyroid)
• Neonatal Cephalic
• Adult Cephalic
• Cardiac (adult and pediatric)
• Peripheral Vascular
• Musculo-skeletal Conventional and Superficial
• Urology (including prostate)
• Transrectal
• Transvaginal
• Transesophageal
• Intraoperative (abdominal, thoracic, vascular and
neurosurgical)
CAUTION
This machine should be used in compliance with law. Some
jurisdictions restrict certain uses, such as gender
determination.

Getting Started
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Contraindication
The LOGIQ E9 ultrasound system is not intended for ophthalmic
use or any use causing the acoustic beam to pass through the
eye.
Only qualified physicians or sonographers should perform
ultrasound scanning on human subjects for medical diagnostic
reasons. Request training, if needed.

Console Overview
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Important Notices
Do not attempt to install the system alone. General Electric,
Affiliate, or Distributor Field Engineers and Application
Specialists will install and setup the system. See ‘Contact
Information’ on page 3-42 for more information.
NOTICE This medical equipment is approved, in terms of the prevention
of radio wave interference, to be used in hospitals, clinics and
other institutions which are environmentally qualified. The use of
this equipment in an inappropriate environment may cause
some electronic interference to radios and televisions around
the equipment.
Ensure that the following is provided for the new system:
• A separate power outlet with a 20 amp circuit breaker for
120 VAC for 120V area, 7.5 amp circuit breaker for
220-240VAC for 220/240V area or 15amp circuit breakerfor
100 VAC for Japan.
• Take precautions to ensure that the console is protected
from electromagnetic interference.
Precautions include:
• Operate the console at least 5 meters (15 feet) away
from motors, typewriters, elevators, and other sources
of strong electromagnetic radiation (non-medical grade
UPS must be at least 2 meters (6 feet) away from
console).
• Operation in an enclosed area (wood, plaster or
concrete walls, floors and ceilings) helps prevent
electromagnetic interference.
• Special shielding may be required if the console is to be
operated in the vicinity of radio broadcast equipment.

Getting Started
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Important Notices (continued)
Figure 1-1. Example Plug and Outlet Configurations
1. 100-120 VAC, 1200 VA
Plug and Outlet Configuration
2. 220-240 VAC, 1200 VA
Plug and Outlet Configuration
WARNING
To avoid risk of fire, the system power must be supplied from a
separate, properly rated outlet.
Under no circumstances should the AC power plug be altered,
changed, or adapted to a configuration rated less than
specified. Never use an extension cord or adapter plug.
To help assure grounding reliability, connect to a “hospital
grade” or “hospital only” grounded power outlet.
CAUTION
Use caution to ensure that the power cable does not
disconnect during system use.
If the system is accidentally unplugged, data may be lost.
CAUTION
To avoid leakage current above safety limits as prescribed by
IEC 60601-1 and to ensure continuity of protective earth. DO
NOT connect LOGIQ E9 and mains-operated accessories to a
single or multiple socket extension cord or power strip.

Console Overview
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Console Graphics
The following are illustrations of the console:
Figure 1-2. LOGIQ E9 System (right and left side views)
1. LCD
2. Gel Holder / Specialty Probe Holder
3. Operator Panel, Probe Holders with Cable
Management
4. Brake Release / Up/Down Controls
5. Peripherals (Black/White Printer, CD/DVD
Drive), V Nav option, and Network Activity/
Speed (Green=1 Gigabyte and Yellow=100 Mb)
and Hard Disk Drive Indicator
6. Probe Connectors
7. Brakes
CAUTION
For compatiblity reasons, use only GE approved probes,
peripherals or accessories.
DO NOT connect any probes or accessories without approval
by GE.

Getting Started
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Console Graphics (continued)
Figure 1-3. LOGIQ E9 System (front and back views)
1. Power On/Off; Operator Panel USB Ports
2. Brake and Up/Down Controls
3. Probe Cable Management Hooks (underneath
Operator Panel)
4. Black/White Printer
5. CD/DVD Drive
6. Network and Hard Disk Drive Indicators. USB
Ports
7. Patient I/O (ECG, CW Probe Connector)
8. Volume Navigation Connectors
9. Probe Connectors
10. Brake Pedal
11. Rear Handle
12. Power Cord Hook
13. Op Panel Up/Down Manual Release Lever
14. Access to Peripheral USB Ports, Audio In/Out,
DVI Connector, Ethernet Connectors, S-Video
15. Breaker, Ground and Power Cord
16. Back Filter
WARNING
DO NOT touch the patient and any of the connectors on the
ultrasound unit simultaneously, including ultrasound probe
connectors.
DO NOT touch the conducting parts of the USB, Ethernet,
Video, Audio cables when connecting equipment to the unit.