InveniaTM Automated Breast Ultrasound System (ABUS) complies with regulatory
requiem, concerning medical devices, and is certified by TUV Rheinland LGA
Products GmbH (CE
This product complies with regulatory requirements of the following European
Directive 93/42/EEC concerning medical devices.
This manual is a reference for the Invenia ABUS. It applies to Version 1
Revision 0.0 software for the Invenia ABUS System Setup.
0197
).
Page 3
Change history
/Revision History
Date
Revision
Rev. 12013-11-4Preliminary
Rev. 22014-01-16Updated Version
Rev. 32014-02-08Update Manual Name and Quality Assurance Personnel
Rev.42014-08-20UDI Label Update
Rev. 52015/02/03Workstation software only option update
Rev. 62015/07/09CE Mark Labeling Update
(YYYY-MM-DD)
Reason for change
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Important precautions
Translation policy
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Damage in transportation
All packages should be closely examined at time of delivery. If
damage is apparent, write “Damage In Shipment” on ALL copies
of the freight or express bill BEFORE delivery is accepted or
“signed for” by a GE representative or hospital receiving agent.
Whether noted or concealed, damage MUST be reported to the
carrier immediately upon discovery, or in any event, within 14
days after receipt, and the contents and containers held for
inspection by the carrier. A transportation company will not pay
a claim for damage if an inspection is not requested within this
14 day period.
Certified electrical contractor statement - For USA Only
All electrical Installations that are preliminary to positioning of
the equipment at the site prepared for the equipment shall be
performed by licensed electrical contractors. Other connections
between pieces of electrical equipment, calibrations and testing
shall be performed by qualified personnel. In performing all
electrical work on these products, GE will use its own specially
trained field engineers. All of GE’s electrical work on these
products will comply with the requirements of the applicable
electrical codes.
The purchaser of GE equipment shall only utilize qualified
personnel (i.e., GE’s field engineers, personnel of third-party
service companies with equivalent training, or licensed
electricians) to perform electrical servicing on the equipment.
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Omission and errors
If there are any omissions, errors or suggestions for improving
this documentation, contact the Global Documentation Group
with specific information listing the system type, manual title,
part number, revision number, page number and suggestion
details.
Mail the
information to:Service Documentation
447 Indio Way
SUNNYVALE, CA 94085
USA
Tel: (408) 328-7924 Fax: (408) 738-9156
GE employees should use the complaint handling system to
report service documentation issues.
These issues will then be in the internal problem reporting tool
and communicated to the writer.
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Service Safety Considerations
DANGER
WARNING
DANGEROUS VOLTAGES, CAPABLE OF
CAUSING DEATH, ARE PRESENT IN THIS
EQUIPMENT. USE EXTREME CAUTION WHEN
HANDLING, TESTING AND ADJUSTING.
Use all Personal Protection Equipment (PPE) such as gloves,
safety shoes, safety glasses, and kneeling pad, to reduce the
risk of injury.
For a complete review of all safety requirements, refer to
Chapter 1 in the Service Manual.
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Legal notes
Trademarks
Copyrights
The contents of this publication may not be copied or duplicated
in any form, in whole or in part, without prior written permission.
GE may revise this publication from time to time without written
notice.
All products and their name brands are trademarks of their
respective holders.
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Chapter 1
Introduction
This chapter describes important issues related to
safely servicing the Invenia ABUS Scan Station, Invenia
ABUS Workstation, and Invenia ABUS Review
Software. The service provider must read and
understand all the information presented here before
installing or servicing the Invenia ABUS Scan Station,
Invenia ABUS Workstation, and Invenia ABUS Review
Software.
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Introduction
Contents in this manual
This manual provides installation and service information for the
Invenia ABUS Scan Station, Invenia ABUS Workstation, and
Invenia ABUS Review Software.
The manual is divided into ten chapters.
In the beginning of the manual, before Chapter 1, you will find
the Revision overview, the Important precautions including
Translation policy, Damage in transportation, Certified electrical
contractor statement, Omission & errors, Service safety
considerations and Legal notes, and the Table of Contents.
An Index has been included after Chapter 10.
Manual Overview
Table 1-1: Contents in this manual
Chapter
Number
1. IntroductionContains a content summary and warnings.
2. Site preparationsContains pre-setup requirements for the Invenia ABUS.
3. System SetupContains setup procedure with procedure checklist.
4. General Procedures and
5. Components and
6. Service AdjustmentsContains instructions on how to make any available adjustments
7. Diagnostics/
8. Replacement proceduresProvides disassembly procedures and reassembly procedures
9. Renewal PartsContains a list of replacement parts for Invenia ABUS.
10. Care & MaintenanceProvides maintenance procedures for Invenia ABUS.
ChapterTtitleDescription
Contains functional checks that must be performed as part of the
Functional Checks
Functions (Theory)
Troubleshooting
installation, or as required during servicing and periodic
maintenance.
Contains and functional explanations of the electronics.
to the Invenia ABUS.
Provides procedures for running diagnostic or related routines
for the Invenia ABUS.
for all changeable FRU.
IndexIndexA quick way to the topic you’re looking for.
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Manual Overview
Typical users of the System Setup and Basic Service Manual
• GE Service Personnel (setup, maintenance, etc.)
• Invenia ABUS User
• Licensed Hospitals’ Service Providers
• Technical Trainers
Invenia ABUS models covered by this manual
Table 1-2: Invenia ABUS Models and Hardware/Software Compatibility
Model
NumberDescriptionSystem SWAppl. SW
H5014SSInvenia ABUS Scan StationWindows 7
Professional
H5014WSInvenia ABUS WorkstationWindows 7
Professional
H5014SWInvenia ABUS Review SoftwareWindows 7
Professional
The InveniaTM Automated Breast Ultrasound System (ABUS)
comes with a review workstation available as software only
(Invenia ABUS Review Software) or with dedicated hardware
(Invenia ABUS Workstation).
NOTE: When not otherwise specified, the contents of this manual
applies to all Invenia ABUS models.
Version 1 Revision x.x
Version 2 Revision x.x
Version 2 Revision x.x
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Introduction
Product Overview
Invenia ABUS Scan Station and System
The Invenia ABUS is composed of the following components:
• Invenia ABUS Scan Station
• Invenia ABUS Workstation or Invenia ABUS Review
Software
After performing the exam study on the Scan Station, the exam
study is transferred to the Invenia ABUS over the DICOM
network. After reviewing the patient’s study on the workstation,
the study is sent to PACS for archiving, or to some other form of
manual archive.
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Invenia ABUS Scan Station and System (continued)
For more information on the Invenia ABUS Scan Station, please
refer to the Invenia ABUS Scan Station Basic User Manual, Part
Number 4700-0014-00.
For more information on the Workstation, please refer to the
Invenia ABUS Workstation and Invenia ABUS Review Software
Basic User Manual, Part Number 4700-0015-00.
Product Overview
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Introduction
Invenia ABUS Scan Station and System (continued)
The InveniaTM Automated Breast Ultrasound System (ABUS)
comes with a review workstation available as software only
(Invenia ABUS Review Software) or with dedicated hardware
(Invenia ABUS Workstation).
There are three (3) distinctions to note with regard to the naming
conventions used in this manual:
• Workstation. A generic name for computer hardware,
provided by GE or by a 3rd party, running the Invenia ABUS
Review Software.
• 3rd Party Workstation. Computer hardware, provided by a
3rd party, running the Invenia ABUS Review Software.
• Invenia ABUS Workstation. Computer hardware, provided
by GE, running the Invenia ABUS Review Software.
Figure 1-2.Invenia ABUS Scan Station and Invenia ABUS Workstation
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Invenia ABUS Scan Station
The Invenia ABUS is intended to be used in medical practices
and in clinical departments and serves the purposes as a review
station for the radiologist’s interpretation of images, electronic
documentation of examinations in the form of text and images
and generation of medical reports.
• Ultrasound engine with articulating arm
• Scanner Assembly with C15-6XW Reverse Curve
transducer
• Rotating Touch Screen monitor
• Workstation (please refer to the Workstation User Manual)
Product Overview
TM
Figure 1-3.Invenia ABUS Overview
Table 1-3: Main System Components
1. Rotating Touch Screen Monitor
2. Ultrasound Coupling Lotion
Holders
3. Power Cord, Mains Power
Switch, and Network Connector
(not shown, on back of system)
4. System Standby Button (On/
Off)
5. Articulating Arm
6. Scanner Assembly with
C15-6XW Reverse Curve
transducer
TM
This section will walk you through how to use the Touch Screen
monitor and scanner assembly to perform the ABUS scan. In
addition, this section will discuss how to move the system and
set the front and rear brakes.
NOTE: The Invenia ABUS Scan Station is ideally positioned with the
articulating arm adjacent to the top right or left corner of the bed.
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Introduction
Invenia ABUS Workstation and Review Software
The Invenia ABUS Review Software will typically be used in a
mammography reading room environment, normally with low
ambient light levels next to a mammography reading station and
a DICOM workstation.
The Invenia ABUS Review Software is designed to accept,
transfer, display, store and process medical images and data.
Invenia ABUS Review Software enables the user to optimize,
measure and annotate the images. The Invenia ABUS Review
Software provides images to enable Physicians to differentiate
normal and abnormal breast tissue and is intended for use by
Health Care Professionals only.
The Invenia ABUS Review Software displays three-dimensional
data sets for viewing in three orthogonal planes and standard
Ultrasound images, permitting Interpreting Physicians to quickly
rerview, locate, and mark regions of interest.
The Invenia ABUS Workstation, if provided, includes the
following components:
1. Monitor and Computer, with proprietary GE software
2. Keyboard
3. Mouse
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Product Overview
Direct Network Connection Between the Invenia ABUS Scan Station and
Workstation to PACS (typical configuration)
Exam studies are sent from the Invenia ABUS Scan Station to
the Invenia ABUS Review Software directly and reviewed by the
Interpreting Physician before they are archived.
Figure 1-4.Review Prior to Archival
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Introduction
Connection Through a Storage system, such as PACS
Exams are archived first to Storage and then reviewed by an
Interpreting Physician at any Invenia ABUS connected to the
network.
Storage and Archive
Figure 1-5.Connection through a PACS
The Workstation provides temporary storage for approximately
200 patient studies. The workstation can be configured to
maintain 10, 20, 30, 40, or 50 percent of the available disk space
free to ensure good workstation performance. If free space
reaches a percentage under the configured limit specified by the
user, a warning appears when logging into the Invenia ABUS
application. Old reviewed studies are then deleted (oldest first)
overnight or when the workstation is powered up the next time.
Transfers from the Invenia ABUS Scan Station are rejected if
free disk space falls below 5%. Scans will not transfer to the
Workstation if there is not enough disk space. Suspended or
un-reviewed studies are never automatically deleted in this
manner. Deleted studies can only be re-displayed if the whole
study was stored to PACS or external storage and re-imported.
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Product Overview
Product description in this Manual
Overview of the Invenia ABUS Scan Station and Workstation
This Invenia ABUS is a high performance digital ultrasound
imaging system with total data management via the Workstation.
Signal flows from the Probe Connector Panel through the
Invenia ABUS Scan Station and finally to the monitor.
System configuration is stored on the Scan Station and
Workstation. Each have their configuration locally.
All necessary software is loaded from the hard drive on power
up.
History - hardware/software versions
Please refer to Chapter 9 in this manual.
Field Replaceable Units (FRUs)
Please refer to Chapter 8 in this manual.
How to turn the Invenia ABUS Scan Station and Workstation ON and OFF
Please refer to Chapter 4 in this manual.
How to check for hardware/software version
To verify the hardware versions on the boards, please refer to
Chapter 4 in this manual.
Purpose of the operator manual(s)
The operator manuals should be fully read and understood
before operating the Invenia ABUS.
The online versions of the operator manuals are available via
the Help function on Invenia ABUS’s operator panel.
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Introduction
Conventions used in book
Important conventions, used in this document, are described
next.
Model designations
This manual covers the Invenia ABUS Scan Station and
Workstation (Invenia ABUS Workstation and Invenia ABUS
Review Software).
‘Invenia ABUS models covered by this manual’ on page 1-3.
Icons
Important conventions
Pictures, or icons, are used wherever they will reinforce the
printed message. The icons, labels, and conventions used on
the product and in the service information are described in this
chapter.
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Safety precaution messages
Various levels of safety precaution messages may be found on
the equipment and in the service information. The different
levels of concern are identified by a flag word that precedes the
precautionary message. Known or potential hazards to
personnel are labeled in one of three ways:
• DANGER
• WARNING
• CAUTION
Important conventions
DANGER
WARNING
CAUTION
NOTE: Notes are used to provide important information about an item
NOTE: Be sure to read the notes; the information contained in a note
Danger is used to indicate the presence of a hazard that will
cause severe personal injury or death if the instructions are
ignored.
Warning is used to indicate the presence of a hazard that can
cause severe personal injury and property damage if
instructions are ignored.
Caution is used to indicate the presence of a hazard that will or
can cause minor personal injury and property damage if
instructions are ignored. Equipment damage possible.
or a procedure.
can often save you time or effort.
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Introduction
Standard hazard icons
Important information will always be preceded by either the
exclamation point (!) contained within a triangle, or the symbols
for “Danger”, “Warning” or “Caution”, as seen throughout this
chapter. In addition to text, several different graphical icons
(symbols) may be used to make you aware of specific types of
hazards that could possibly cause harm. Even if a symbol isn’t
used in this manual, it may be included for your reference.
Table 1-4: Standard hazard icons
ELECTRICAL
MECHANICAL
HEAT
PINCH
MAGNET PACEMAKER
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Important conventions
Standard Icons that indicate that a special procedure is to be used
Some others icons make you aware of specific procedures that
should be followed.
Table 1-5: Standard Icons that indicates that a special procedure is to be used
Avoid Static ElectricityTag and LockoutWear Eye Protection
Hand ProtectionFoot ProtectionWear Eye Protection
Be sure to read the notes; the information contained in a note
can often save you time or effort.
Product icons
Always refer to the product’s User Manual for a full list of labels
used on the Invenia ABUS Scan Station and Workstation.
Labels locations
It is important to refer to the current revision of the Invenia ABUS
Scan Station and Workstation User Manuals for a full list of
product labels prior to servicing the system.
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Introduction
Introduction
Human Safety
Safety considerations
The following safety precautions must be observed during all
phases of operation, service and repair of this equipment.
Failure to comply with these precautions or with specific
warnings elsewhere in this manual, violates safety standards of
design, manufacture and intended use of the equipment.
• Operating personnel must not remove the system covers.
• Servicing should be performed by authorized personnel
only.
WARNING
This equipment contains dangerous voltages that are capable
of serious injury or death.
If any defects are observed or malfunctions occur, stop
operating the equipment and perform the proper action for the
patient. Inform a qualified service person and contact a Service
Representative for information.
There are no user serviceable components inside the console.
Refer all servicing to qualified service personnel only.
Ensure that unauthorized personnel do not tamper with the
unit.
The warranty is void if covers have been removed.
Only personnel who have participated in an Invenia ABUS Scan
Station and Workstation Training Seminar are authorized to
service the internal components of this equipment.
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Human Safety (continued)
Safety considerations
DANGER
DANGER
WARNING
WARNING
DANGEROUS VOLTAGES, CAPABLE OF
CAUSING DEATH, ARE PRESENT IN THIS
EQUIPMENT. USE EXTREME CAUTION WHEN
HANDLING, TESTING AND ADJUSTING.
WHERE APPLICABLE, THERE ARE SEVERAL PLACES ON
THE IMAGING ENGINE CHASSIS, THE AC DISTRIBUTION,
DC DISTRIBUTION, AND TIP BOARD THAT ARE
DANGEROUS. BE SURE TO POWER DOWN THE SYSTEM,
TURN OFF THE MAINS POWER SWITCH AND
DISCONNECT THE MAINS POWER CABLE FROM THE
WALL OUTLET BEFORE YOU REMOVE ANY PARTS. BE
CAUTIOUS WHENEVER POWER IS STILL ON AND
COVERS ARE REMOVED.
If the covers are removed from an operating Invenia ABUS
Scan Station, some metal surfaces may be warm enough to
pose a potential heat hazard if touched, even while in
shutdown mode.
Because of the limited access to cabinets and equipment in the
field, placing people in awkward positions, GE has limited the
lifting weight for one person in the field to 16 KG (35 LBS).
Anything over 16 KG (35 LBS) requires 2 people.
WARNING
Attempts to move the Invenia ABUS Scan Station considerable
distances or on an incline by one person could result in injury
or damage or both.
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Introduction
Human Safety (continued)
WARNING
WARNING
WARNING
WARNING
Explosion Warning
DO NOT operate the equipment in an explosive atmosphere.
Operation of any electrical equipment in such an environment
constitutes a definite safety hazard.
DO NOT substitute parts or modify equipment
Because of the danger of introducing additional hazards, ONLY
install GE approved parts. DO NOT perform any unauthorized
modification of the equipment.
Ensure that the Invenia ABUS Scan Station is turned off and
unplugged
Wait for at least 20 seconds for capacitors to discharge as
there are no test points to verify isolation.
Invenia ABUS Scan Station components may be energized.
Always refer to LOTO warnings and cautions
Risk of electrical shock, Invenia ABUS Scan Station must be
turned off and disconnected from power source. Cord must be
controlled at all times.
Wait for at least 20 seconds for capacitors to discharge as
there are no test points to verify isolation.
Invenia ABUS Scan Station components may be energized.
Always refer to LOTO warnings and cautions
WARNING
1-18Invenia ABUS – System Setup and Basic Service Manual
Tilting the console requires two people in order to avoid injury
to service personnel and damage to the equipment.
4700-0021-00 Rev. 6
Page 39
Human Safety (continued)
Safety considerations
WARNING
WARNING
WARNING
Use all Personal Protection Equipment (PPE) such as gloves,
safety shoes, safety glasses, and kneeling pad, to reduce the
risk of injury.
Beware of possible sharp edges on all mechanical parts. If
sharp edges are encountered, the appropriate PPE should be
used to reduce the risk of injury.
Wear all PPE including gloves as indicated in the chemical
MSDS.
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Introduction
Lockout/Tagout (LOTO) requirements
Lockout/Tagout
Follow Lockout/Tagout requirements by ensuring you are in total
control of the AC power plug at all times during the service
process.
To apply Lockout/Tagout (LOTO):
1. Plan and prepare for shutdown.
2. Shutdown the equipment.
3. Isolate the equipment.
4. Apply Lockout/Tagout Devices.
5. Control all stored and residual energy.
6. Verify isolation.
All potentially hazardous stored or residual energy is relieved.
Energy Control and Power Lockout
WARNING
Energy Control and Power Lockout for Invenia ABUS.
When servicing parts of the Invenia ABUS Scan Station where
there is exposure to voltage greater than 30 volts:
1. Follow LOCKOUT/TAGOUT procedures.
2. Turn off the Power Mains Switch.
3. Unplug the Invenia ABUS Scan Station.
4. Maintain control of the Invenia ABUS Scan Station power
plug.
5. Wait for at least 20 seconds for capacitors to discharge as
there are no test points to verify isolation.
Invenia ABUS Scan Station components may be energized.
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Dangerous procedure warnings
Warnings, such as the example below, precede potentially
dangerous procedures throughout this manual. Instructions
contained in the warnings must be followed.
Safety considerations
DANGER
WARNING
WARNING
WARNING
DANGEROUS VOLTAGES, CAPABLE OF
CAUSING DEATH, ARE PRESENT IN THIS
EQUIPMENT. USE EXTREME CAUTION WHEN
HANDLING, TESTING AND ADJUSTING.
If the covers are removed from an operating Invenia ABUS,
some metal surfaces may be warm enough to pose a potential
heat hazard if touched, even while in shutdown mode.
Explosion Warning
DO NOT operate the equipment in an explosive atmosphere.
Operation of any electrical equipment in such an environment
constitutes a definite safety hazard.
DO NOT substitute parts or modify equipment
Because of the danger of introducing additional hazards, ONLY
install GE approved parts. DO NOT perform any unauthorized
modification of the equipment.
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Introduction
Electrical safety
Safe practices
Follow these guidelines to minimize shock hazards whenever
you are using the Invenia ABUS Scan Station:
• To minimize shock hazard, the equipment chassis must be
connected to an electrical ground.
• The Invenia ABUS Scan Station is equipped with a
three-conductor AC power cable. This must be plugged into
an approved electrical outlet with safety ground.
• The power outlet used for this equipment should not be
shared with other types of equipment.
• Both the system power cable and the power connector must
meet international electrical standards
WARNING
Transducer
Connecting a Invenia ABUS to the wrong voltage level will
most likely destroy it.
Follow these guidelines before connecting the transducer to the
Invenia ABUS:
• Inspect the probe prior to each use for damage or
degradation to the:
• housing
• lens
• seal
• connector pins
• Do not use a damaged or defective probe.
• Never immerse the probe connector or adapter into any
liquid.
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Mechanical safety
Safety considerations
WARNING
WARNING
WARNING
WARNING
While the software install procedure is designed to preserve
data, ensure that all patient exams have transferred to the
Workstation or PACS.
Ultrasound probes are highly sensitive medical instruments
that can easily be damaged by improper handling. Use care
when handling and protect from damage when not in use. do
not use a damaged or defective probe. Failure to follow these
precautions can result in serious injury and equipment
damage.
Never use a probe that has fallen to the floor. Even if it looks
OK, it may be damaged.
When the Invenia ABUS Scan Station is raised for a repair or
moved along any incline, use extreme caution since it may
become unstable and tip over.
CAUTION
Invenia ABUS – System Setup and Basic Service Manual1-23
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Invenia ABUS weighs 123 kg (271 lbs.) when ready for use.
Care must be used when moving it or replacing its parts.
Failure to follow the precautions listed below could result in
injury, uncontrolled motion and costly damage.
ALWAYS:
• be sure the pathway is clear
• use slow, careful motions
• use two people when moving on inclines or lifting more
than 16 kg (35 lbs)
Page 44
Introduction
Mechanical safety (continued)
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Before you move or transport the Invenia ABUS Scan Station,
make sure to lock the Touch Screen monitor and Articulating
Arm to prevent damage to the Invenia ABUS Scan Station.
To avoid injury when you move the Touch Screen monitor and
the Articulating Arm, do not put your finger, hand, or object on
the joint of the monitor or the monitor arm.
Keep the heat venting holes on the Touch Screen monitor
unobstructed to avoid overheating of the monitor.
Do not transport Invenia ABUS in a vehicle without locking the
casters (wheels) and securing it as described in the User
Manual.
Use protective glasses during drilling, filing smooth surfaces,
and during all other work where eyes need protection.
CAUTION
CAUTION
1-24Invenia ABUS – System Setup and Basic Service Manual
Practice good ESD prevention. Wear an anti–static strap when
handling electronic parts and even when disconnecting/
connecting cables.
Do not pull out or insert circuit boards while power is on.
4700-0021-00 Rev. 6
Page 45
Mechanical safety (continued)
Safety considerations
CAUTION
CAUTION
CAUTION
Do not operate this Invenia ABUS Scan Station unless all
board covers and frame panels are securely in place. System
performance and cooling require this.
Use safety shoes when doing work where there is any chance
of foot injury.
Use protective gloves when working with sharp edges or when
directed to wear PPE during a removal/replacement procedure.
CAUTION
NOTE: Special care should be taken when transporting the Invenia
Invenia ABUS – System Setup and Basic Service Manual1-25
4700-0021-00 Rev. 6
Be careful not to pinch any of the cables.
ABUS in a vehicle:
• Before transporting, place the system in its special storage
container.
• Ensure that the system is firmly secured while inside the
vehicle.
• Secure system with straps or as directed otherwise to
prevent motion during transport.
• Prevent vibration damage by driving cautiously. Avoid
unpaved roads, excessive speeds, and erratic stops or
starts.
Page 46
Introduction
Electromagnetic compatibility (EMC)
What is EMC?
Electromagnetic compatibility describes a level of performance
of a device within its electromagnetic environment. This
environment consists of the device itself and its surroundings
including other equipment, power sources and persons with
which the device must interface. Inadequate compatibility
results when a susceptible device fails to perform as intended
due interference from its environment or when the device
produces unacceptable levels of emission to its environment.
This interference is often referred to as radio–frequency or
electromagnetic interference (RFI/EMI) and can be radiated
through space or conducted over interconnecting power of
signal cables. In addition to electromagnetic energy, EMC also
includes possible effects from electrical fields, magnetic fields,
electrostatic discharge and disturbances in the electrical power
supply.
Compliance
Invenia ABUS conforms to all applicable conducted and radiated
emission limits and to immunity from electrostatic discharge,
radiated and conducted RF fields, magnetic fields and power
line transient requirements.
For applicable standards, refer to the Safety Chapter of the
Invenia ABUS Scan Station and Invenia ABUS Workstation and
Invenia ABUS Review Software User’s Manuals.
NOTE: It is critical that all covers, screws, shielding, gaskets, mesh,
clamps, are in good condition, installed tightly without skew or
stress. Proper installation following all comments noted in this
service manual is required in order to achieve full EMC
performance.
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Electromagnetic compatibility (EMC)
Electrostatic discharge (ESD) prevention
WARNING
WARNING
DO NOT touch any boards with integrated circuits prior to
taking the necessary ESD precautions.
Always connect yourself, via an arm-wrist strap, to the advised
ESD connection point located on the rear of the Invenia ABUS
Scan Station (near the power connector).
Follow general guidelines for handling of electrostatic sensitive
equipment.
Risk of electrical shock, Invenia ABUS Scan Station must be
turned off. Avoid all contact with electrical contacts, conductors
and components. Always use non-conductive handles
designed for the removal and replacement of ESD sensitive
parts. All parts that have the potential for storing energy must
be discharged or isolated before making contact.
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Introduction
Contact information
Customer assistance
If this equipment does not work as indicated in this service
manual or in the user manual, or if you require additional
assistance, please contact the GE Service or appropriate
support resource. Note the following:
1. System ID serial number.
2. Software version.
3. Date and time of occurrence.
4. Sequence of events leading to issue.
5. Is the issue repeatable?
Refer to Figure 3-1 to locate the System ID Serial Number on
the Invenia ABUS Scan Station and Invenia ABUS Workstation.
Specific label descriptions can be found in the user manuals.
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Phone numbers for Customer Assistance
Table 1-6: Phone numbers for Customer Assistance
LOCATIONPHONE NUMBER
Customer assistance
USA/Canada
GE Medical Systems
Ultrasound & Primary Care Diagnostics, LLC
9900 Innovation Drive
Wauwatosa, WI 53226
Latin AmericaService
EMEA
GE Ultraschall Deutschland Gmbh & Co. KG
Beethovenstrasse 239
Postfach 11 05 60, D-42655 Solingen
Germany
EAGM
Egypt Service Center
UAE Service Center
Asia (Singapore)
GE Ultrasound Asia
Service Department - Ultrasound
298 Tiong Bahru Road #15-01/06
Central Placa
Singapore 168730
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Introduction
System manufacturer
Table 1-7: System manufacturer
MANUFACTURER
U-Systems, Inc.
447 Indio Way
Sunnyvale, CA 94085
USA
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Returning the probe and repair parts
Equipment being returned must be clean and free of blood and
other infectious substances. Policy states that body fluids must
be properly removed from any part or equipment prior to
shipment. Employees, as well as customers, are responsible for
ensuring that parts/equipment have been properly
decontaminated prior to shipment. Under no circumstance
should a part or equipment with visible body fluids be taken or
shipped from a clinic or site (for example, body coils or an
ultrasound probe).
The purpose of the regulation is to protect employees in the
transportation industry, as well as the people who will receive or
open this package.
Returning parts
Returning parts
NOTE: The US Department of Transportation (DOT) has ruled that
“items that were saturated and/or dripping with human blood
that are now caked with dried blood; or which were used or
intended for use in patient care” are “regulated medical waste”
for transportation purposes and must be transported as a
hazardous material.
NOTE: The USER/SERVICE staff should dispose of all the waste
properly, per federal, state, and local waste disposal regulations.
The Invenia ABUS is not meant to be used for long-term storage
of patient data or images. The user is responsible for the data on
the system.
If the system is sent for repair, please ensure that any patient
information is backed up and erased from the system before
shipping. It is always possible during system failure and repair to
lose patient data. GE is not responsible for the loss of this data.
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Introduction
Returning the probe and repair parts (continued)
If PHI (Patient Healthcare Information) data needs to be sent to
GE employees for service purposes, GE will ascertain
agreement from the customer. Patient information shall only be
transferred by approved service processes, tools and devices
restricting access, protecting or encrypting data where required,
and providing traceability in the form of paper or electronic
documents at each stage of the procedure while maintaining
compliance with cross-border restrictions of patient information
transfers.
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Chapter 2
Site Preparations
This chapter provides the information required to plan
and prepare for the setup of an Invenia ABUS Scan
Station, Invenia ABUS Workstation, and Invenia ABUS
Review Software. Included are descriptions of the
facility and electrical needs to be met by the purchaser
of the Invenia ABUS Scan Station, Invenia ABUS
Workstation, and Invenia ABUS Review Software.
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Site Preparations
General Invenia ABUS requirements
Invenia ABUS Scan Station environmental requirements
If the Invenia ABUS Scan Station is very cold or hot
When unpacking the Invenia ABUS Scan Station, allow the
temperature of the Invenia ABUS Scan Station to stabilize
before powering up. The following table describes guidelines for
reaching operational temperatures from storage or transport
temperatures.
CAUTION
Cooling
If the Invenia ABUS Scan Station is very cold or hot, do not turn
on its power until it has had a chance to acclimate to its
operating environment.
Table 2-1: Invenia ABUS Scan Station acclimate time
The cooling requirement for a typical console Ultrasound system
with monitor and on board peripherals, is up to 3800 BTU/h.
This figure does not include cooling needed for lights, people, or
other equipment in the room.
NOTE: Each person in the room places an additional 300 BTU/h
demand on the cooling system.
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Lighting
General Invenia ABUS requirements
Bright light is needed for Invenia ABUS Scan Station setup,
updates, and repairs. However, operator and patient comfort
may be optimized if the room light is subdued and indirect.
Therefore a combination lighting system (dim/bright) is
recommended. Keep in mind that lighting controls and dimmers
can be a source of Electromagnetic Interference (EMI) which
could degrade image quality. These controls should be selected
to minimize possible interference.
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Site Preparations
Electrical requirements
General requirements
The Invenia ABUS Scan Station requires a dedicated power and
ground for the proper operation of its Ultrasound equipment. A
separate power outlet with a minimum 10 amp circuit breaker for
100-240 VAC.
NOTE: Please note that image artifacts can occur, if at any time within
the facility, the ground from the main facility's incoming power
source to the Invenia ABUS Scan Station is only a conduit.
CAUTION
Power outage may occur. The Invenia ABUS requires a
dedicated single branch circuit. To avoid circuit overload and
possible loss of critical care equipment, make sure you do not
have any other equipment operating on the same circuit.
Site power outlets
A dedicated AC power outlet must be within reach of the Invenia
ABUS Scan Station without extension cords. Other outlets
adequate for the external peripherals, medical and test
equipment needed to support this Invenia ABUS Scan Station
must also be present within 1 m (3.2 ft.) of the Invenia ABUS
Scan Station. Electrical installation must meet all current local,
state, and national electrical codes.
Unit power plug
Refer to Chapter 9 for Power Plug part numbers. If the Invenia
ABUS Scan Station and Workstation arrives without a power
plug, or with the wrong plug, you must contact your GE dealer or
the installation engineer must supply what is locally required.
Power stability requirements
Voltage drop-out:
Max 10 ms.
Power transients (all applications):
Less than 25% of nominal peak voltage for less than 1
millisecond for any time of transient, including line frequency,
synchronous, asynchronous, or aperiodic transients.
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Power stability requirement
Table 2-2: Power Stability Requirement
General Invenia ABUS requirements
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
EMI limitations
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 s
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 s
Mains power quality
should be that of a
typical commercial or
hospital environment.
Ultrasound systems are susceptible to Electromagnetic
Interference (EMI) from radio frequencies, magnetic fields, and
transients in the air or wiring. They also generate EMI. The
Invenia ABUS Scan Station and Invenia ABUS Workstation
complies with limits as stated on the EMC label. However there
is no guarantee that interference will not occur in a particular
installation.
Possible EMI sources should be identified before the Invenia
ABUS Scan Station and Workstation are set up.
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Site Preparations
EMI limitations (continued)
Electrical and electronic equipment may produce EMI
unintentionally as the result of a defect. Some of these sources
include:
• medical lasers
• scanners
• cauterizing guns
• computers
• monitors
• fans
• gel warmers
• microwave ovens
• light dimmers
• mobile phones
• in-house wireless phones (DECT phones)
• wireless computer keyboard and mouse
• air conditioning system
• High Frequency (HF) surgery equipment
• general AC/DC adapters
The presence of a broadcast station or broadcast van may also
cause interference.
See: ‘EMI prevention/abatement’ on page 2-7 for EMI
prevention tips.
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General Invenia ABUS requirements
EMI prevention/abatement
Table 2-3: EMI prevention/abatement
EMI RULEDETAILS
Be aware of Radio
Frequency sources
Ground the
Ultrasound system
Replace all screws,
Radio Frequency
gaskets, covers,
cores
Replace broken
Radio Frequency
gaskets
Do not place labels
where Radio
Frequency gaskets
touch metal
Take care with
cellular phones
• Keep the Invenia ABUS Scan Station at least 5 meters (15 feet) away from other
EMI sources.
• Special shielding may be required to eliminate interference problems caused by
high frequency, high powered radio or video broadcast signals.
Poor grounding is the most likely reason an Ultrasound system will have noisy
images. Check grounding of the power cord and power outlet.
• After you finish repairing or updating the Ultrasound system, replace all covers
and tighten all screws.
• Any cable with an external connection requires a magnet wrap at each end.
• Install all covers. Loose or missing covers or Radio Frequency gaskets allow
radio frequencies to interfere with the ultrasound signals.
If more than 20% or a pair of the fingers on an Radio Frequency gasket are
broken, replace the gasket. Do not turn on the Ultrasound system until any loose
metallic part is removed.
Where applicable, never place a label where Radio Frequency gaskets meet the
Ultrasound system. Otherwise, the gap created will permit Radio Frequency
leakage. Or, if a label has been found in such a position, move the label.
Cellular phones may transmit a 5 V/m signal; that could cause image artifacts.
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Site Preparations
Purchaser responsibilities
The work and materials needed to prepare the site is the
responsibility of the purchaser. Delay, confusion, and waste of
manpower can be avoided by completing pre-installation work
before delivery. Purchaser responsibility includes:
• Procuring the materials required
• Completing the preparations before delivery of the
Ultrasound system (See Site Survey Planner below).
• Paying the costs for any alterations and modifications not
specifically provided in the sales contract
NOTE: All electrical installations that are preliminary to the positioning
of the equipment at the site prepared for the equipment must be
performed by licensed electrical contractors. Other connections
between pieces of electrical equipment, calibrations, and testing
must also be performed by qualified personnel. The products
involved (and the accompanying electrical installations) are
highly sophisticated and special engineering competence is
required. All electrical work on these products must comply with
the requirements of applicable electrical codes. The purchaser
of GE equipment must only utilize qualified personnel to perform
electrical servicing on the equipment.
Facility needs
The desire to use a non–listed or customer provided product or
to place an approved product further from the Ultrasound
system than the interface kit allows, presents challenges to the
installation team. To avoid delays during installation, such
variances should be made known to the individuals or group
performing the installation at the earliest possible date
(preferably prior to the purchase).
The ultrasound suite must be clean prior to delivery of the
Ultrasound system. Carpet is not recommended because it
collects dust and creates static. Potential sources of EMI
(electromagnetic interference) should also be investigated
before delivery. Dirt, static, and EMI can negatively impact
Ultrasound system reliability.
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Facility needs
Site Survey Planner
Use the Site Survey Planner on the next two pages to help with
your planning activities.
You can also download this form (part number 9000-0014-01) from the Common
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Facility needs
_
_
_
Pre-Installation Site Survey Worksheet
DICOM MODALITY WORKLIST
Does your facility intend to utilize a DICOM modality
worklist to supply patient appointment data to ABUS?
If yes, please provide the DICOM
modality worklist information:
IP Address: ____.____.____.____ Gateway: ____.____.____.____ IP Address: ____.____.____.____ Gateway: ____.____.____.____
Store Print Query/RetrieveStore Print Query/Retrieve
Please Note: The ABUS workstation does not accept compre ssed image data les. So, while ABUS 3D image data may be
compressed when it is pushed to PACS or an alternative NAS, it must be uncompressed before it is pulled back to the workstation .
How many complete 3D ABUS exams do you plan to
push to storage during a typical week?
If Yes, please describe: ______________________________________________________________________________________________
3D ABUS exams will be stored (600MB) Only select 2D images will be stored
Storage on PACS Storage on facility’s network attached storage (NAS)
No image data will be stored Other _________________________________
Do you plan to utilize a secondary PACS or other
______
long-term archival system for 3D ABUS exams?
YesNo
ABUS DELIVERY INSTRUCTIONS
Is a loading dock available at the facility? YesNo If Yes, what are the hours?
Will a delivery truck with a lift gate be required? YesNo How many drivers will be needed for unloading? OneTwo
What will happen to the ABUS crate after delivery? Return to U-SystemsDisposal by Customer Storage by Customer
Site specied delivery time: _____AM PM Special notes: _______________________________________________________
____AM to_____ PM M-F Other____
ADDITIONAL SCAN STATIONS and/or WORKSTATIONS
Will multiple scan stations an d/or workstations be installed?
Scan Station 2 Room Number:
Scan Station 2 Location Relative to Scan Station 1:
Workstation 2 Room Number:
Workstation 2 Location Relative to Workstation 1:
AE Title: _____________________
IP Address: _____._____._____.__________._____._____._____ Workstation DNS: _____._____._____._____
Subnet Mask: _____._____._____.__________._____._____._____ Workstation Alt DNS: _____._____._____._____
Gateway: _____._____._____.__________._____._____._____ Workstation Internet Access: Yes No
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Site Preparations
Time and manpower requirements
Site preparation takes time. Begin site preparation checks as
soon as possible, if possible, six weeks before delivery, to allow
enough time to make any changes.
Facility needs
The following are required:
• Dedicated single branch power outlet of adequate
amperage, meeting all local and national codes, which is
located less than 2.5 m (8 ft.) from the Ultrasound system’s
proposed location
• Door opening is at least 76 cm (30 in) wide
• Proposed location for Ultrasound system is at least 0.5 m
(1.5 ft.) from the wall for cooling
• Power outlet and place for any external peripheral are within
2 m (6.5 ft.) of each other with peripheral within 1 m of the
Ultrasound system to connect cables.
• Power outlets for other medical equipment
• Power outlets for test equipment within 1 m (3.2 ft.) of
Ultrasound system
• Material to safely clean probes (done with a plastic
container, never metal)
The following are desired:
• Door is at least 92 cm (3 ft.) wide
• Circuit breaker for dedicated power outlet is easily
accessible
• Sink with hot and cold water
• Receptacle for bio–hazardous waste, for Single Use
Stabilization Membrane
• Storage for linens and equipment
• Nearby waiting room, lavatory, and dressing room
• Dual level lighting (bright and dim)
• Storage area for Single Use Stabilization Membranes and
Ultrasound Coupling Lotion
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Facility needs
Important Notices
General Electric, Affiliate, or Distributor Field Engineers and
Application Specialists will setup the system.
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 minimum of a minimum 10
amp circuit breaker for 100-240 VAC.
• 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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Site Preparations
Important Notices (continued)
WARNING
CAUTION
CAUTION
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
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.
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 Invenia ABUS Scan Station or Workstation and
mains-operated accessories to a single or multiple socket
extension cord or power strip.
The Invenia ABUS requires a dedicated power and ground for
the proper operation of its Ultrasound equipment. A separate
power outlet with a minimum 10 amp circuit breaker for 100-240
VAC.
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Invenia ABUS Scan Station
Facility needs
Figure 2-3.Typical Room Layout for the Invenia ABUS Scan Station
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Site Preparations
Invenia ABUS Scan Station (continued)
Figure 2-4.Desired Footprint
1. Maximum arm reach is ~1 m, or 39”
2. ~0.76 m, or 30” clear space recommended
3. ~0.61 m, or 24” clear space recommended
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Invenia ABUS Scan Station (continued)
Facility needs
Figure 2-5.Invenia ABUS Scan Station
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Site Preparations
Invenia ABUS Scan Station System Specifications
System Features
• Multi-slice B-Mode image acquisition with frame-by-frame
3D position registration
• User-customizable workflow protocols
• Image Processing Algorithms
• Tissue Equalization Algorithm (TEA)
• Speckle Reduction
• Nipple Shadow Compensation (NSC)
• Breast Border Detection
• Chest Wall Detection
• Acquisition Scout Images
• Transverse Plane (Real-time)
• Coronal Plane (Static, for Nipple Placement)
• DICOM 3.0 Compliant
• Worklist (DMWL)
• Modality Performed Procedure Step (MPPS)
• Store (SCU)
• 10/100/1000 Base-T Ethernet
• User-Replaceable Fan Filter
• Remote Service Diagnostics
• Embedded User Manual
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Invenia ABUS Scan Station System Specifications (continued)
Scanner Assembly Features
• Compression Assist
• Increase/Decrease Compression
• Start Scan (one-touch volume acquisition)
• Abort Scan
• Ergonomic Arm with 3 Operator-selectable Levels of
Compression between 5-20 lbs (2.25-9.7 kg)
• Integrated, extra-wide transducer:
TM
• C15-6XW Reverse Curve
• Frequency Range: 6-15 MHz
• Aperture Length: 15.3 cm
• Transducer Travel Distance: 16.9 cm
• Number of Elements: 768
• Element Pitch: 0.20 mm
• Out-of-plane Aperture: 3.5 mm
• Transducer Bandwidth: 85%
• Imaging Depth: Up to 5.0 cm
Facility needs
• Single-Use Stabilization Membrane
• Single Volume Acquisition in less than 60 Seconds
• Multi-Row LED Task Lighting
• Removeable Scanner View Window, for easier clean-up
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Site Preparations
Invenia ABUS Scan Station System Specifications (continued)
Specifications
• Width: 23 inches (59 cm)
• Length: 26 inches (66 cm)
• Height (Arm):
Lowest Position 65 inches (165 cm)
Highest Position 85 inches (216 cm)
• Footprint: 4.2 sq. ft. (0.39 sq. m)
• Weight: 271 lbs (123 kg)
• Articulating Arm Reach (max): 39 inches (100 cm)
• Main Voltage: 100-240 VAC
• Maximum Current: 10 amps
• Mains Frequency: 50/60 Hz
• HDD Data Capacity: 200 GB (approximately 200 Studies),
with Storage Status Indicator
• Study Transfer: Auto and Manual
• Display: 17” High Resolution LCD Touch Screen
• Cart: Mobile platform with 4-wheel steering and braking
• Operating System: MS Windows 7 Professional, 64 bit
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Invenia ABUS Review Software
Facility needs
Figure 2-6.Invenia ABUS Review Software
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Site Preparations
Invenia ABUS Workstation System Specifications
NOTE: Workstation Specifications are only applicable for the Invenia
ABUS Workstation Option.
Image Display and Navigation
• Individual user-defined Hanging and Viewing Protocols
• Multi-Slice Viewing: 4-12 Images
• Streamlined Review Protocols
• Standardized View Orientations: Thick-slice Coronal,
Transverse, Sagittal, Radial, Anti-radial, and ROI Views
• Variable Slice Thickness: 0.5 to 10.00 mm (increments of
0.5 mm)
• Grayscale Windowing and Leveling
• Pan and Zoom Feature
• 4X Magnifying Tool
• CINE Review with Adjustable Playback Speed
• 360 Degree Any Point of Compass Display
• Side-by-Side Display for Coronal View Comparison
• Right-Click Graphical Navigational Tools
Networking/Storage/Archiving
• User Login Authentication
• DICOM 3.0 Compliant:
• Query/Retrieval SCU
• Store SCP/SCU
• Print SCU
• 10/100/1000 Base-T Ethernet
• Compatible Media Storage
• USB Media Stick
• DVD +/- RW
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Invenia ABUS Workstation System Specifications (continued)
Annotation and Reporting
• 3-Dimensional Position Referencing By:
• Clock Position
• Distance from Nipploe
• Depth from Skin Surface
• Measurement Toolbox
• Standardized Labeling for Scan Positions
• Graphic Labels for Scan Position and Clock Position
• Customizable auto Report Function with User-Selectable
Images
• Patient Study Browser
• Patient List Filtering Based on User’s Setting
Hardware Specifications
• Tower: Workstation Class Hardware
• Operating System: Windows 7 Professional, 64 bit
• Display: 24-inch (diagonal) Display
Facility needs
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Site Preparations
Workstation Hardware Specifications for ABUS Review Software
Operating System (O.S.)
• Windows 7 Professional 64 Bit
Monitor
Minimum Requirements:
• Dedicated 24" Color Monitor
• Minimum resolution 1920x1200
Recommended Monitor Specs:
• 24” or greater diagonal size
• 1920 x 1200 resolution or higher
• LED backlit, Color Panel
• Brightness 250 cd/m or greater
• Contrast Ratio 1000:1 or higher
Input Devices
• Standard Keyboard
• Mouse with 3 Buttons and Scroll Wheel with individually
distinct detents
Available Disk Space
Video Card
NOTE: On-board GPU (e.g Intel HD graphics) is not supported.
Hard Drive with 400MB reserved for application and separate
Hard Drive/disk space for Exams (1GB per exam, recommend
300 exams cache)
Minimum requirements at installation:
• 300 GB of available space
• Support for OpenGL 3.3 or Higher
• 2 GB GDDR5 Dedicated Video Memory or more
• Memory Bandwidth 100GB/s or higher
• Support Resolution of at least 1920 x 1200 at 60Hz
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Facility needs
Workstation Hardware Specifications for ABUS Review Software (continued)
Processor, Memory
• Xeon E5-1620 3.6GHz or better
• 8.0GB RAM or better
Minimum requirements at installation:
• 8.0 GB of RAM
Database
The Invenia ABUS software uses MySQL database. The
database is installed and configure automatically during the
installation process.
No other instances of MySQL database are supported on the
same computer.
Networking/Storage/Archiving
• 10/100/1000 Base-T Ethernet
• Compatible Media Storage
• USB Media Stick
• DVD +/- RW
I/O ports
• One or more USB 2.0 port
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Site Preparations
Environmental Requirements
The system should be operated, stored, or transported within
the parameters outlined below. Either its operational
environment must be constantly maintained or the unit must be
turned off.
NOTE: You may get an overheating message with regard to fan speed.
Ensure adequate system/room ventilation.
Table 2-4: System Environmental Requirements
OperationalStorageTransport (<16hrs.)
Temperature5° - 35°C
41° - 95°F
Humidity30% to 75%
non-condensing
Altitude0-3,000 m (9,800 feet)0-5,000 m (16,400 feet)0-5,000 m (16,400 feet)
-10° - 60°C
14° - 140°F
10% to 85%
non-condensing
-10° - 60°C
14° - 140°F
10% to 85%
non-condensing
Packaging Information
The shipping crate size is 55”L x 34”W x 73”H (1.4m L x 0.86m
W x 1.85m H).
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Networking setup requirements
Networking setup requirements
Scanner connected to hospital’s network
Supported networks:
10/100/1000 Base-T Ethernet
InSite Requirements
InSite ExC allows GE to remotely assist users, Biomedical
Technicians, and Field Service personnel by using a secure
remote connection across the network.
Internet access is needed to be able to connect to InSite ExC.
The following is needed to configure InSite:
• System IP Address
• Default Gateway
• Proxy Server, if necessary, and Port
• Proxy Authentication, if necessary
• User Name and Password
• System ID (SID) Number
Purpose of the DICOM network function
DICOM services provide the operator with clinically useful
features for moving images and patient information over a
hospital network.
Examples of DICOM services include the transfer of images to
workstations for viewing or transferring images to remote
printers.
As an added benefit, transferring images in this manner frees up
the on-board monitor and peripherals, enabling viewing to be
done while scanning continues.
With DICOM, images can be archived, stored, and retrieved
faster, easier, and at a lower cost.
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Site Preparations
DICOM setup requirements
To configure the Ultrasound system to work with other network
connections, the site’s network administrator must provide
information to complete the form “Worksheet for DICOM
Network Information”. Ensure that there are no spaces in any
field of the form.
Entries must include:
• A host name, local port number, AE Title, IP address and
Net Mask for the Ultrasound system.
• The IP addresses for the default gateway and other routers
at the site for ROUTING INFORMATION.
• The host name, IP address, port and AE Title for each
device the site wants connected to the Ultrasound system
for DICOM APPLICATION INFORMATION. A field for the
make (manufacturer) and the revision of the device, is also
included. This information may be useful for error solving.
Refer to the Site Planning worksheet on the Figure 2-1 on page 2-10.
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Environmental Dangers
Environmental Dangers
Commercial devices such as laser cameras, printers, VCRs and
external monitors, usually exceed allowable leakage current
limits and, when plugged into separate AC outlets, are in
violation of patient safety standards. Suitable electrical isolation
of such external AC outlets, or providing the device with extra
protective earth, will be required in order to meet UL60601-1
and IEC60601-1 / IEC60601-1-1 standards for electrical
leakage.
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Site Preparations
Patient Vicinity UL60601-1 (USA)
NOTE: This section is only applicable if the Workstation is provided by
GE (Invenia ABUS Option).
2.12.20DV (UL60601-1:2003)
In area in which patients are normally cared for, the patient
vicinity is the space with surfaces likely to be contacted by the
patient or attendant who can touch the patient. This encloses a
space within the room 1.83 m (6 ft.) beyond the perimeter of the
bed (examination table, dental chair, treatment booth, and the
like) in its intended location, and extending vertically 2.29 m
(7.5 ft.) above the floor.
1. Patient environment
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Chapter 3
System Setup
This chapter contains information needed to install
Invenia ABUS.
Included is a procedure that describes how to receive
and unpack the equipment and how to file a damage or
loss claim.
How to set up the system and how to check and test the
unit, probes, and external peripherals for electrical
safety are also included in this procedure.
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System Setup
Average setup time
Setup warnings
Setup reminders
• Unpacking the Invenia ABUS: 0.5 hour
• Set up Scan Station and Workstation: 3 hours or more,
depending on the configuration
• DICOM Network Configuration: 3 hours or more, depending
on the configuration
• Install InSite: 0.5 hour
DANGER
CAUTION
CAUTION
CAUTION
CAUTION
WHEN USING ANY TEST INSTRUMENT THAT IS CAPABLE
OF OPENING THE AC GROUND LINE (I.E., METER’S
GROUND SWITCH IS OPEN), DON’T TOUCH THE
ULTRASOUND SYSTEM!
To prevent electrical shock, connect the unit to a properly
grounded power outlet. Do not use a three to two prong
adapter. This defeats safety grounding.
Do not wear the ESD wrist strap when you work on live circuits
and more than 30 V peak is present.
Do not operate this unit unless all board covers and frame
panels are securely in place. System performance and cooling
require this.
The system must be supplied by an adequately rated electrical
circuit. The capacity of the supply circuit must be as specified.
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Setup warnings (continued)
Setup reminders
CAUTION
CAUTION
If the Ultrasound system is very cold or hot, do not turn on its
power until it has had a chance to acclimate to its operating
environment.
The following table describes guidelines for reaching operational
temperatures from storage or transport temperatures.
Operator Manual(s)
The User Manual(s) should be fully read and understood
before operating the Invenia ABUS and kept near the
Ultrasound system for quick reference.
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System Setup
Receiving and unpacking the
Warnings for receiving and unpacking
equipment
CAUTION
CAUTION
Attempts to move the Ultrasound system considerable
distances or on an incline by one person could result in injury
or damage or both.
Two people are required whenever a part weighing 16 KG (35
LBS) or more must be lifted.
Remember to use relevant personal protecting equipment
(PPE) during packing and unpacking. Check with your local
EHS representative.
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The Tilt & Shock indicators
Overview
Improper handling during transportation may harm the
equipment inside the package even if the package itself is
undamaged.
To make it easier to detect if the handling during transportation
has been improper, a set of Tilt & Shock indicators have been
attached to the transportation box.
Table 3-1: Shock and Tilt Watch
DescriptionIllustration
ShockWatch
Receiving and unpacking the equipment
Tilt Watch
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System Setup
Receiving the Invenia ABUS
Overview
Improper handling during transportation may harm the
equipment inside the package even if the package itself is
undamaged.
Examine all packages
Examine package closely at time of delivery, as described in the
procedure below.
Table 3-2: Examine all packages
StepTaskIllustrations
1. Is damage apparent?
• If YES; continue with the instructions in
‘Damage in transportation’ on page 3-10.
• If NO; continue with the next step.
2. Is the Shock Indicator red colored inside the
middle of the indicator?
• If YES: The Shock Indicator has been
activated. Continue with the instructions in
‘Damage in transportation’ on page 3-10,
then continue with the next step.
• If NO: continue with the next step.
1 - Red Color
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Receiving and unpacking the equipment
Table 3-2: Examine all packages (Continued)
StepTaskIllustrations
3. Is the Tilt Indicator red colored inside the
middle of the indicator?
• If YES: The Tilt Indicator has been
activated. Continue with the instructions in
‘Damage in transportation’ on page 3-10
before you continue with the next step.
• If NO: continue with the next step.
4. Continue with the instructions in ‘Unpacking
the Invenia ABUS’ on page 3-11.
1 - Red Color
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System Setup
Position of the Tilt & Shock indicators
The Tilt & Shock indicators have been attached to the
transportation crate.
NOTE: Before cutting the straps, check Shock and Tilt Tags to make
sure they have not been triggered. If damaged, report it to the
carrier. If not, then cut the straps around the crate.
If Shock Indicator has triggered or is missing
The purpose of a shock indicator label is NOT to tell if a product
has been damaged during shipment. The purpose of these
labels are to alert people handling a package that the product
contained is very sensitive to shock damage and that it should
be handled carefully. It is basically an active "Fragile" label that
turns red if a predetermined shock does occur. Because the
labels can receive false activation due to an impact shock
directly on the label, an activated label must not be interpreted
to mean product damage. It simply means that the receiver
should note on the shipping papers at the time of receipt that the
label was activated and the product should be inspected for
possible concealed damage. Conversely, a high level,
product-damaging shock could occur to the package in a way
that does not activate the label, so a non activated label does
not insure that the product is not damaged. Some degree of
inspection is still required.
Table 3-3: Shock Indicator has triggered or is missing
StepTas k
1. If the Shock Indicator is missing:
Note on the shipping papers at the time of receipt that the
Shock Indicator label is missing.
If the Shock Indicator has triggered:
Note on the shipping papers at the time of receipt that the
Shock Indicator label was activated.
2. Inspect the product for possible concealed damage.
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Receiving and unpacking the equipment
If Tilt Indicator has triggered or is missing
The purpose of the tilt indicator label is to alert people handling a
product that it is sensitive to tipping and it must remain upright at
all times. It is basically an active "Up Arrow" that changes color if
the package is tipped 89 degrees or more from horizontal.
These labels can be false activated if tipped less than 89
degrees, and shocked or vibrated at the same time. This event
does occur, but is considered uncommon. If a package is
received with an activated tilt indicator label, there is high
degree of certainty it tipped 89 degrees or more from horizontal
during shipment.
An activated tilt indicator label does not indicate if the package
was simply “Tipped” (laid down with no impact shock) or “Tipped
Over” (free fall, with an impact shock). Using both shock
indicator labels and tilt indicator labels will help identify if a Tip
Over impact shock occurred.
Table 3-4: Tilt Indicator has triggered or is missing
StepTas k
1. If the Tilt Indicator is missing:
2. Inspect the product for possible concealed damage.
Note on the shipping papers at the time of receipt that the
Tilt Indicator label is missing.
If the Tilt Indicator has triggered:
Note on the shipping papers at the time of receipt that the
Tilt Indicator label was activated.
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System Setup
Damage in transportation
Follow this procedure if damage is apparent:
1. Write “Damage In Shipment” on ALL copies of the freight or
express bill BEFORE delivery is accepted or “signed for“ by
a GE representative or hospital receiving agent.
2. Report the damage to the carrier.
• Whether noted or concealed, damage MUST be
reported to the carrier immediately upon discovery, or in
any event, within 14 days after receipt, and the contents
and containers held for inspection by the carrier.
• A transportation company will not pay a claim for
damage if an inspection is not requested within this 14
day period.
Invenia ABUS transportation box label
The Invenia ABUS transportation crate label is located at the
front of the transportation crate.
Table 3-5: transportation box label
SymbolsDefinition/Comments
1. TOP,. UPRIGHT - Transportation and Storage
2. FRAGILE, Handle with Care
3. RECYCLING
4. KEEP DRY (protect from moisture)
1
3
2
4
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Receiving and unpacking the equipment
Unpacking the Invenia ABUS
Instructions are provided in the materials attached to the
Shipping Crate.
Table 3-6: Unpacking the Invenia ABUS Scan Station and Workstation
StepsIllustration
1. Carefully remove any shipping straps that secure the front door/ramp and back door.
2. Lift the hasp handles away from the crate.
Repeat for the step for the other three hasps.
3. Rotate the hasp handles counterclockwise to
release.
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System Setup
Table 3-6: Unpacking the Invenia ABUS Scan Station and Workstation
StepsIllustration
4. Slowly lower the front door/ramp until it rests on
the floor.
5. Remove any loose packaging, if present.
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Table 3-6: Unpacking the Invenia ABUS Scan Station and Workstation
StepsIllustration
6. Lift the front blocking plate up and out of the
crate.
7. If the wheel locks are locked, release the
brakes.
Receiving and unpacking the equipment
Slowly roll/remove the Invenia ABUS Scan
Station straight out of the crate.
8. Repeat the steps for opening the hasps, on the crate back door.
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System Setup
Table 3-6: Unpacking the Invenia ABUS Scan Station and Workstation
StepsIllustration
9. Slowly swing the door open and remove the
Workstation (if ordered) and any other supplies.
10. Remove all of the packaging and place the removed packaging back into the crate to store for possible
future use.
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Packing materials
Packing materials - recycling information
Packing materials -
recycling information
The packing materials for Invenia ABUS are recyclable:
• The Transportation Box is made of spruce or similar
material. (“PHYTOSANITARY CERTIFICATE” included in
all shipments to The People's Republic of China.)
• Lever lockings (hinges) are made of zinc plated steel.
• The inner reinforcements are made of Ethafoam
(Polyethylene foam).
• The plastic foil is made of LDPE (Low Density
Polyethylene).
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System Setup
Verify customer order
Compare items received by the customer to that which is listed
on the delivery order. Report any items that are missing, back
ordered, or damaged.
Physical inspection
Verify that the system arrived intact (visual inspection).
If the system has been damaged, please refer to ‘Damage in
transportation’ on page i-11 in the beginning of this manual.
Preparing for setup
EMI protection
The Invenia ABUS has been designed to minimize the effects of
Electro-Magnetic Interference (EMI). Many of the covers,
shields, and screws are provided primarily to protect the system
from image artifacts caused by this interference. For this reason,
it is imperative that all covers and hardware are installed and
secured before the unit is put into operation.
See ‘EMI limitations’ on page 2-5 for more information about
EMI protection.
The Invenia ABUS has been designed to minimize the effects of
Electro-Magnetic Interference (EMI). Many of the covers,
shields, and screws are provided primarily to protect the system
from image artifacts caused by this interference. For this reason,
it is imperative that all covers and hardware are installed and
secured before the unit is put into operation.
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Product Labels and Descriptions
Preparing for setup
Figure 3-1.Product Labels
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System Setup
Product Labels and Descriptions (continued)
Table 3-7: Rear Panel Label Explanations
1. “ATTENTION” - Consult accompanying
documents” is intended to alert the user to refer
to the operator manual or other instructions
when complete information cannot be provided
on the label.
2. TUV Rhineland Label: NRTL Listing and
Certification Mark is used to designate
conformance to nationally recognized product
safety standards. The Mark bears the name
and/or logo of the testing laboratory, product
category, safety standard to which conformity is
assessed, and a control number.
3. The CE Mark of Conformity indicates this
equipment conforms with the Council Directive
93/42/EEC.
4. Prescription Device (For U.S.A. Only)
5. BF Applied Part
6. Identification and Rating Plate–USA/Asia 120V
console
7. CISPR Emissions Label
8. System and Probe IP Code
9. Mercury Warning Label
10. WEEE Symbol
11. Possible shock hazard. Do not remove covers
or panels. No user serviceable parts are inside.
Refer servicing to qualified service personnel.
12. The equipment weighs approximately 123 kg
(271 lbs). To avoid possible injury and
equipment damage when transporting from one
area of use to another:
• Be sure the pathway is clear.
• Limit movement to a slow careful walk.
• Use two or more persons to move the
equipment on inclines or long distance.
13. Fuse Label
14. Invenia ABUS Scan Station (A), Workstation
Rating Plate (B) and Invenia ABUS Review
Software CD Label (C)
• Manufacturer’s name and address
• Part Number
• Model/Serial Number/Date of Manufacturer
3-18Invenia ABUS – System Setup and Basic Service Manual
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