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GE Sales Representative or in the USA call the GE Ultra sound Clinical Answer Center at
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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 med ica l devic es :
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: +49 761 45 43 -0; Fax: +49 761 45 43 -233
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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
Console Overview, Moving the System, System
Start-up, Probes and Beginning an Exam
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1-1
Getting Started
Attention
Console Overview
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. Period ica lly
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 th e late st
information.
NOTE: Please note that orders are based on the individually agreed
NOTE: All references to standards / regulations and their revisions are
Prescription Device
upon specifications and may not cont ain all features listed in t his
manual.
valid at the time of publication of the user manual.
CAUTION: United States law restricts this device to sale or use
by, or on the order of a physician.
1-2
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Indications for Use
CAUTION
Frequency of Use
Operator Profile
Clinical Applications
Console Overview
The LOGIQ E9 is intended for use by a qualified physician for
ultrasound evaluation.
Daily (Typically 8 hours)
• Qualified and trained physicians or sonographers with at
least basic ultrasound knowledge.
• The operator must have read and understood the user
manual.
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)
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This machine should be used in compliance with law. Some
jurisdictions restrict certain uses, such as gender
determination.
1-3
Getting Started
Contraindication
The LOGIQ E9 ultrasound system is not intended for ophthalmic
use or any use causing the acoustic beam to pa ss through the
eye.
Only qualified physicians or sonographers should perform
ultrasound scanning on human subjects for medical diagnostic
reasons. Request training, if needed.
1-4
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Console Overview
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 te lev ision s ar ou n d
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
220-240V AC for 220/240V ar ea or 15 amp circuit breaker for
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.
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Getting Started
WARNING
CAUTION
CAUTION
Important Notices (continued)
To avoid risk of fire, the syst em po we r must be sup plie d fr om 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.
Use caution to ensure that the power cable does not
disconnect during system use.
If the system is accidentally unplugged, data may be lost.
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.
1-6
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
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Console Graphics
CAUTION
Console Overview
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
For compatiblity reasons, use only GE approved probes,
peripherals or accessories.
DO NOT connect any probes or accessories without approval
by GE.
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. Network and Hard Disk Drive Indicators. USB
Ports
7. Patient I/O (ECG, CW Probe Connector)
8. Volume Navigation Connectors
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.
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
1-8
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USB Ports
CAUTION
CAUTION
CAUTION
Operator Panel
Console Overview
Peripheral devices that use their own AC power source canno t
be attached to the system.
The two Operator Panel USB Ports SHOULD ONLY BE USED
for Bus-powered USB Hard Disk Drives and USB Flash Drives.
The following configurations can be used:
• One or two USB Flash Drives
• One Flash Drive and One Bus-powered Hard Disk Drive
• One Bus-powered Hard Disk Drive
DO NOT plug in TWO Bus-powered Hard Disk Drives at the
same time.
Below Operator Panel and Rear of System
The two USB ports at the back of the system and the two USB
ports below the Operator Panel SHOULD ONLY BE USED for
the following devices:
• Color or Report Printer
NOTE: When connecting an external printer to the LOGIQ E9 via
the USB port on the back of the system, you MUST ensure
that the power supplied to the printer is fed from the same
power feed as the LOGIQ E9. This assures compliance to
leakage currents.
• Flash Drive
• Service Key
ONLY plug in devices to the USB ports located at the rear of
the system WHILE the LOGIQ E9 is NOT powered up . If you
plug in a device while the LOGIQ E9 is powered on, your
system may become unusable.
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1-9
Getting Started
CAUTION
CAUTION
CAUTION
Peripheral/Accessory Connector Panel
LOGIQ E9 peripherals CAN ONLY BE properly connected using
the Peripheral/Accessory Connector Panel located behind the
rear door: Color Digital or Report printer, Audio In/Out, DVI
Analog Video Output, S-Video, and Ethernet.
For compatiblity reasons, use only GE-approved prob es,
peripherals, or accessories.
DO NOT connect any probes or accessories without approval
by GE.
The connection of equipment or transmission networks other
than as specified in these instructions can result in electric
shock hazard. Alternate connections will require verification of
compatibility and conformity to IEC/EN 60601-1-1 by the
installer.
To avoid breaking the back cover while opening it in order to
connect up the network cable, use a paper clip an d pull hard to
open up the back cover door.
3. Reports: Activates default report and Touch
Panel of report choices.
4. End Exam: Activates Image Management and
Touch Panel with end of exam options.
NOTE: Different menus are displayed depending on which Touch Panel
is selected.
At the bottom of the Touch Panel, there are five combination
rotary dials/push buttons. The functiona lity of these rotaries
changes, depending upon the currently-displayed menu. Press
the button to switch between controls, or rot ate the dial to adjust
the value, or move the control left/right or up/down to adjust the
value.
5. Utility: Activates system configuration menus.
6. Model: Selects the application to use.
7. Probe Indicator: Indicates and selects the
probes.
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Monitor Display
Console Overview
Figure 1-7.Monitor Display Tour
Figure 1-8.Monitor Display Tour 2
NOTE: The date on the monitor may truncate the century when using
the YYYY-MM-DD date format.
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Getting Started
Monitor Display (continued)
1. Institution/Hospital Name, Date, Time, Operator
Identification.
15. Imaging Parameters by Mode, SoS indicator (if
applicable).
16. Focal Zone Indicator.
17. TGC.
18. Depth Scale.
19. Body Pattern.
20. Cine Gauge.
21. Current date and time, Caps Lock: (lit when on),
network connection indicator (PC=connected,
PC with X=not connected), wireless LAN
indicator (WLAN=connected, WLAN with X=not
connected), DVR status, InSite ExC status,
InSite ExC controls, system messages display.
22. Image Management Icons:
a. Compare Assistant
b. Active Images screen
c. Delete Images screen
d. Next/Previous Image(s); and Clipboard Slide
Show if you press and hold down the [Ctrl]
key + Next or Previous Arrow
e. Save As Menu
f. Number of Images in Exam
g. Thumbnail Size
23. Trackball Key Functionality Status.
24. 6Tc Probe temperature display
25. 6Tc Probe angle display
1-16
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Brightness
Console Overview
Adjusting the monitor's brightness is one of the most important
factors for proper image quality. If these controls are set
incorrectly, the Gain, TGC, Dynamic Range and even Power
Output may have to be changed more often than necessary to
compensate.
The proper setup displays a complete gray scale. The lowest
level of black should just disappear into the backgr ound and the
highest white should be bright, but not saturated.
To adjust the brightness:
1. Press the right adjustment button to increase brightness.
2. Press the left adjustment button to decre ase brightness.
The amount of brightness is shown on a slide bar on the
screen.
Figure 1-9.Brightness adjustment button
1. Adjustment (+) Button
2. Adjust (-) Button
Record any changes to the final brightness settings and leave
this information with the system. Generally speaking, do not
change the controls once they have been set. Once set, the
display then becomes the reference for the hard copy device(s).
Table 1-2: Brightness Settings (Recommended)
Room ConditionBrightness
Dark Room (Factory default)60
Bright Room100
NOTE: After readjusting the monitor's Brightness, readjust all preset
and peripheral settings.
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Getting Started
Before moving the system
1. Press the Power On/Off switch to power off the system.
See ‘Power Off’ on page 1-25 for more information.
2. Unplug the power cord.
3. All cables from off-board peripheral devices (external Color
Digital/Report printer, etc.) and the ethernet connection
must be disconnected from the console.
4. Ensure that no loose items are left on the console.
5. Wind the power cable around the cable hook below the rear
handle.
NOTE: To prevent damage to the Power Cord, DO NOT pull
excessively on the cord or make sharp bends while
wrapping.
Moving the System
6. Connect all probes to be used while off site. Ensure that
probe cables are out of the way from the wheels and not
protruding beyond the console. Use the probe manageme nt
hooks located below the Operator Panel to further secure
the probe cables.
NOTE: If more than four (4) probes are intended to be used, store
the additional probes securely.
7. Store all other probes in their original cases or in soft cloth
or foam to prevent damage.
1-18
LOGIQ E9
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Rev. 1
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