This manual is a reference for the Invenia ABUS 2.0.
It applies to Version 2.0 software or later.
0197
).
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Change history
Revision History
Date
Revision
Rev. 12018-07-19Initial release
Rev. 22019-01-04Update package information and unpacking procedure
Rev. 32019-01-18Update revision number
Rev. 42019-04-07Update device label information
PagesRevisionPagesRevision
FrontRev. 4Chapter 6Rev. 4
Front matterRev. 4Chapter 7Rev. 4
TOCRev. 4Chapter 8Rev. 4
Chapter 1Rev. 4Chapter 9Rev. 4
(YYYY-MM-DD)Reason for change
List of Effected Pages (LOEP)
Chapter 2Rev. 4Chapter 10Rev. 4
Chapter 3Rev. 4IndexRev. 4
Chapter 4Rev. 4Rear CoverRev. 4
Chapter 5Rev. 4
Please verify that you are using the latest revision of this document. Information
pertaining to this document is maintained in the Engineering Central portion in
MyWorkshop. 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.
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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, please contact the GE Global Ultrasound
Documentation Group with specific information listing the
system type, manual title, part number, revision number, page
number and suggestion details.
Mail the
information to:
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
9900 Innovation Drive
Wauwatosa, WI 53226
GE employees should use Post-market Quality Management
(PQM) 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
provider must read and understand all the information
presented here before installing or servicing the Invenia
ABUS 2.0.
TM
2.0. The service
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Introduction
Contents in this manual
This manual provides installation and service information for the
Invenia ABUS 2.0.
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.
Table 1-1: Contents in this manual
Manual Overview
Chapter
NumberChapter TitleDescription
1. IntroductionContains a content summary and warnings.
2. Site preparationsContains pre-setup requirements for the Invenia ABUS 2.0.
3. System SetupContains setup procedure with procedure checklist.
4. General Procedures and
Functional Checks
5. Components and
Functions (Theory)
6. Service AdjustmentsContains instructions on how to make any available adjustments
7. Diagnostics/
Troubleshooting
8. Replacement proceduresProvides disassembly procedures and reassembly procedures
9. Renewal PartsContains a list of replacement parts for Invenia ABUS 2.0.
10. Care & MaintenanceProvides maintenance procedures for Invenia ABUS 2.0.
IndexIndexA quick way to the topic you’re looking for.
Contains functional checks that must be performed as part of the
installation, or as required during servicing and periodic
maintenance.
Contains functional explanations of the electronics.
to the Invenia ABUS 2.0.
Provides procedures for running diagnostic or related routines
for the Invenia ABUS 2.0.
for all changeable FRU.
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Manual Overview
Typical users of the System Setup and Basic Service Manual
• GE Service Personnel (setup, maintenance, etc.)
• Invenia ABUS 2.0 User
• Licensed Hospitals’ Service Providers
• Technical Trainers
Invenia ABUS 2.0 models covered by this manual
Table 1-2: Invenia ABUS 2.0 Models and Hardware/Software Compatibility
Model
NumberDescriptionSystem SWApplication SW
H5018SSInvenia ABUS 2.0, GlobalWindows Embedded Standard 7 64-bitVersion 2.0.3 or later
H5018SCInvenia ABUS 2.0, ChinaWindows Embedded Standard 7 64-bitVersion 2.0.3 or later
NOTE: When not otherwise specified, the contents of this manual
applies to all Invenia ABUS 2.0 models.
Field Replaceable Units (FRUs)
Please refer to Chapter 8 in this manual.
How to turn the Invenia ABUS 2.0 ON and OFF
Please refer to Chapter 4 in this manual.
How to check for software version
To verify the software version on the instrument, please refer to
Chapter 4 in this manual.
Purpose of the operator manual
The operator manual should be fully read and understood
before operating the Invenia ABUS 2.0.
eIFU
Invenia ABUS 2.0 documentation is provided to the customer in
the electronic Instruction for Use Kit (eIFU Kit) that is shipped
with the Invenia ABUS 2.0. The eIFU Kit provides all of the
manuals in all languages. Printed version is available, free of
charge. Check with your GE representative.
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Introduction
Invenia ABUS 2.0
Instrument Overview
The Invenia ABUS* 2.0 displays three-dimensional data sets for
viewing in three orthogonal planes and standard Ultrasound
images, permitting Interpreting Physicians to quickly review,
locate, and mark regions of interest.
Figure 1-1.Invenia ABUS 2.0
The terms “scan station”, “product”, “device” or “instrument” may
be used interchangeably throughout the manual to indicate the
Invenia ABUS 2.0 product.
*
ABUS=Automated Breast Ultrasound System
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Components
Instrument Overview
Figure 1-2.Invenia ABUS 2.0 Overview
1. Scan Head with C15-6XW
Reverse Curve
Ultra-broadband transducer
2. Scan Arm
3. Display Arm with Touch Screen
Monitor
4. Weight Tower
TM
5. Table with Ultrasound Coupling
Lotion Holders
6. System Standby Button (On/Off)
7. Chassis containing Power Cord,
Mains Power Switch, Network
Connector, and USB port (not
shown)
8. Base and
Locking Caster Wheels
Signal flows from the transducer in the Scan Head (1), down the
Weight Tower (4), through the Invenia ABUS 2.0 chassis (7),
and finally to the Display (3).
System configuration is stored on the itself. All necessary
software is loaded from the hard drive upon powerup.
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Introduction
Room Layout
TM
The Invenia ABUS
around the exam table. The following figure shows the
recommended clearance around the table.
2.0 can be place at various positions
Figure 1-3.Minimum space around the exam bed.
Maximum arm reach is 40 inches (1.02 m)
~0.76 m, or 30” clear space recommended
~0.61 m, or 24” clear space recommended
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View-on PACs
Instrument Overview
After performing the exam on the Invenia ABUS 2.0, the exam
can be transferred manually or automatically to a DICOMcompatible viewing station for review. After the review, the exam
can be sent to a PACS for archiving, or to some other form of
manual archive.
Figure 1-4.PACS network
Customers that want more integrated workflows or enterprises
with multiple locations can benefit from the storage and View-on
PACS capability.
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Introduction
Conventions used in book
Important conventions, used in this document, are described
next.
Icons
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.
Important conventions
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Safety precaution messages
DANGER
WARNING
CAUTION
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
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.
Important conventions
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.
NOTE: Notes are used to provide important information about an item
or a procedure.
NOTE: Be sure to read the notes; the information contained in a note
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 1-3: 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 1-4: 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 2.0.
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Introduction
Label locations
It is important to refer to the current revision of the Invenia ABUS
2.0 Basic User Manual for a full list of product labels prior to
servicing the system.
The following figure shows the location of the GE Cares Label
on the Invenia ABUS 2.0 monitor.
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Introduction
DANGER
DANGER
WARNING
Human Safety
Safety considerations
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.
Only personnel who have participated in an Invenia ABUS 2.0
Training Seminar are authorized to service the internal
components of this equipment.
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 2.0,
some metal surfaces may be warm enough to pose a potential
heat hazard if touched, even while in shutdown mode.
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Introduction
WARNING
WARNING
Explosion
Hazard
WARNING
WARNING
WARNING
Human Safety (continued)
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.
Attempts to move the Invenia ABUS 2.0 considerable
distances or on an incline by one person could result in injury
or damage or both.
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 2.0 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 2.0 components may be energized. Always refer
to LOTO warnings and cautions
Tilting the console requires two people in order to avoid injury
to service personnel and damage to the equipment.
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Human Safety (continued)
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.
Safety considerations
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Introduction
DANGER
Explosion
Hazard
WARNING
Dangerous procedure warnings
Warnings, such as the example below, precede potentially
dangerous procedures throughout this manual. Instructions
contained in the warnings must be followed.
DANGEROUS VOLTAGE WARNING
DANGEROUS VOLTAGES, CAPABLE OF CAUSING DEATH,
ARE PRESENT IN THIS EQUIPMENT. USE EXTREME
CAUTION WHEN HANDLING, TESTING AND ADJUSTING.
Heat warning
If the covers are removed from an operating Invenia ABUS 2.0,
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.
Equipment Modification Warning
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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Electrical safety
DANGER
Safe practices
Transducer
Safety considerations
Follow these guidelines to minimize shock hazards whenever
you are using the Invenia ABUS 2.0:
• The Invenia ABUS 2.0 is equipped with a three-conductor
AC power cable. This must be plugged into an approved
electrical outlet with third wire 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
Electrical Warning
Connecting an Invenia ABUS 2.0 to the wrong voltage level will
most likely damage it.
Follow these guidelines before connecting the transducer to the
Invenia ABUS 2.0:
• Inspect the transducer prior to each use for damage or
degradation to the:
• housing
• lens
• seal
• connector pins
• Do not use a damaged or defective transducer.
• Never immerse the transducer connector or adapter into
any liquid.
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Introduction
WARNING
WARNING
WARNING
WARNING
WARNING
Mechanical safety
Personal Injury
Use protective glasses during drilling, filing smooth surfaces,
and during all other work where eyes need protection.
Personal Injury
Use safety shoes when doing work where there is any chance
of foot injury.
Personal Injury
Use protective gloves when working with sharp edges or when
directed to wear PPE during a removal/replacement procedure.
Personal Injury
Do not pull out or insert circuit boards while power is on.
Personal Injury
To avoid injury when you move the Touch Screen Display and
the Display Arm, do not put your finger, hand, or object on the
joint of the Display or the Display arm.
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Mechanical safety (continued)
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
Personal Injury
Invenia ABUS 2.0 weighs 100 kg (220 lb.) 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
personal injury, uncontrolled motion and costly damage.
ALWAYS:
• be sure the pathway is clear
• use slow, careful motions
Equipment Damage
When the Invenia ABUS 2.0 is moved along any incline, use
extreme caution since it may become unstable and tip over.
Safety considerations
Loss of Data
While the software install procedure is designed to preserve
data, ensure that all patient exams have transferred to an
image viewer or storage, such as PACS.
Equipment Damage
Ultrasound transducers 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 transducer. Failure to
follow these precautions can result in serious injury and
equipment damage.
Equipment Damage
Never use a transducer that has fallen to the floor. Even if it
looks OK, it may be damaged.
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Introduction
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Mechanical safety (continued)
Equipment Damage
Before you move or transport the Invenia ABUS 2.0, make sure
to lock the Touch Screen Display and Display Arm to prevent
damage to the Invenia ABUS 2.0.
Equipment Damage
Keep the heat venting holes on the Touch Screen Display
unobstructed to avoid overheating of the Display.
Equipment Damage
Practice good electrostatic discharge (ESD) prevention. Wear
an anti–static strap when handling electronic parts and even
when disconnecting/connecting cables.
Equipment Damage
Do not operate this Invenia ABUS 2.0 unless all board covers
and frame panels are securely in place. System performance
and cooling require this.
Equipment Damage
Be careful not to pinch any of the cables.
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Mechanical safety (continued)
CAUTION
Equipment Damage
Do not transport Invenia ABUS 2.0 in a vehicle without locking
the casters (wheels) and securing it as described in the User
Manual.
NOTE: Special care should be taken when transporting the Invenia
ABUS 2.0 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.
• System must remain upright at all times. Severe damage
may occur if transported other than upright.
Safety considerations
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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 2.0 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 2.0 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)
WARNING
WARNING
Electrostatic discharge (ESD) prevention
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
2.0 (near the power connector).
Follow general guidelines for handling of electrostatic sensitive
equipment.
Risk of electrical shock, Invenia ABUS 2.0 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 3-2 on page 3-35 to locate the System ID Serial
Number on the Invenia ABUS 2.0. Specific label descriptions
can be found in the user manuals.
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Phone numbers for Customer Assistance
Customer assistance
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Introduction
System manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Table 1-5: System manufacturer
MANUFACTURER
9900 Innovation Drive
Wauwatosa, WI 53226
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Returning parts
Returning the transducer 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 transducer).
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
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 2.0 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 as per HIPAA regulation. 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 transducer 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 2.0.
Included are descriptions of the facility and electrical
needs to be met by the purchaser of the Invenia ABUS
2.0.
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Site Preparations
CAUTION
General requirements
Invenia ABUS 2.0 environmental requirements
If the Invenia ABUS 2.0 is very cold or hot
When unpacking the Invenia ABUS 2.0, allow the temperature
of the Invenia ABUS 2.0 to stabilize before powering up. The
following table describes guidelines for reaching operational
temperatures from storage or transport temperatures.
If the Invenia ABUS 2.0 is very cold or hot, do not turn on its
power until it has had a chance to acclimate to its operating
environment.
Cooling
Lighting
Table 2-1: Invenia ABUS 2.0 acclimation 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.
Bright light is needed for Invenia ABUS 2.0 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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Electrical requirements
CAUTION
General requirements
The Invenia ABUS 2.0 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 2.0 is only a conduit.
Power outage may occur. The Invenia ABUS 2.0 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
General requirements
Unit power plug
A dedicated AC power outlet must be within reach of the Invenia
ABUS 2.0 without extension cords. Other outlets adequate for
the external peripherals, medical and test equipment needed to
support this Invenia ABUS 2.0 must also be present within 1 m
(3.2 ft.) of the Invenia ABUS 2.0. Electrical installation must
meet all current local, state, and national electrical codes.
Refer to Chapter 9 for Power Plug part numbers. If the Invenia
ABUS 2.0 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.
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Site Preparations
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.
Table 2-2: Power Stability Requirement
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<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.
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EMI limitations
General requirements
Ultrasound instruments 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 2.0 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 2.0 devices are set up.
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 2-6 for EMI
prevention tips.
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Site Preparations
EMI prevention/abatement
Table 2-3: EMI prevention/abatement
EMI RULEDETAILS
Be aware of Radio
Frequency sources
Ground the
Ultrasound
instrument
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 2.0 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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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
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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Site Preparations
Site Survey Planner
Use the Site Survey Planner to document the information
required to install your Invenia ABUS system.
NOTE: Your sales or support representative can obtain the Site Survey
Planner file, DOC1864913.
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
instrument’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 transducers (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
WARNING
CAUTION
CAUTION
Important Notices (continued)
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 2.0 and mains-operated
accessories to a single or multiple socket extension cord or
power strip.
The Invenia ABUS 2.0 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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Room Layout
Facility needs
The device can be place at various positions around the exam
table. The following figure shows the recommended clearance
around the table.
Figure 2-1.Position A – Desired Footprint
• Maximum arm reach is 40”
• ~0.76 m, or 30” clear side space recommended
• ~0.61 m, or 24” clear front and back space recommended
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Site Preparations
Room Layout (continued)
Figure 2-2.Invenia ABUS 2.0
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Invenia ABUS 2.0 System Specifications
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)
Facility needs
• 10/100/1000 Base-T Ethernet
• User-Replaceable Fan Filter
• Remote Service Diagnostics
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Site Preparations
Scan Head 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:
• 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
TM
• Single-Use Stabilization Membrane
• Single Volume Acquisition in less than 60 Seconds
• Multi-Row LED Task Lighting
• Removeable Scan Head Clear Cast Cover, for easier
clean-up
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Specifications
Facility needs
• 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: 227 lbs (103 kg)
• Articulating Arm Reach (max): 39 inches (100 cm)
• Main Voltage: 100-240 VAC
• Maximum Current: 10 amps
• Mains Frequency: 50/60 Hz
• SSD 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 Embedded Standard,
64 bit
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Site Preparations
Networking setup requirements
Invenia ABUS 2.0 connected to hospital’s network
Supported networks:
10/100/1000 Base-T Ethernet
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
remote viewers 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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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.
Networking setup requirements
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Site Preparations
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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Patient Vicinity UL60601-1 (USA)
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.
Environmental Dangers
1. Patient environment
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Site Preparations
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Chapter 3
System Setup
This chapter contains information needed to install
Invenia ABUS 2.0.
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, transducer, and external peripherals for electrical
safety are also included in this procedure.
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System Setup
DANGER
CAUTION
CAUTION
CAUTION
CAUTION
Average setup time
Setup warnings
Setup Time and Warnings
• Unpacking the Invenia ABUS 2.0: 1 hour
• DICOM Network Configuration: 3 hours or more, depending
on the configuration
WHEN USING ANY TEST INSTRUMENT THAT IS CAPABLE
OF OPENING THE AC GROUND LINE (I.G., 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)
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
The User Manual should be fully read and understood before
operating the Invenia ABUS 2.0 and kept near the Ultrasound
instrument for quick reference.
Setup Time and Warnings
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System Setup
CAUTION
CAUTION
Receiving and Unpacking the
Warnings for receiving and unpacking
Attempts to move the Invenia ABUS 2.0 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.
Equipment
Remember to use relevant personal protecting equipment
(PPE) during packing and unpacking. Check with your local
EHS representative.
Work gloves are highly recommended to protect your hands
while unpacking the crate.
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Receiving and Unpacking the Equipment
Receiving the Invenia ABUS 2.0
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 3-1: Examine all packages
StepTask
1. Is damage apparent?
• If YES; continue with the instructions in ‘Damage in transportation’ on page 3-6.
• If NO; continue with the next step.
2. Continue with the instructions in ‘Unpacking the Invenia ABUS 2.0’ on page 3-9.
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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 2.0 Transportation Box Label
The Invenia ABUS 2.0 transportation crate label is located at the
front of the transportation crate.
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System Setup
Label/IconPurpose/MeaningLocation
Table 3-2: Package Label Icons
Humidity LimitationPackage
Temperature LimitationPackage
Pressure LimitationPackage
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Receiving and Unpacking the Equipment
CAUTION
Unpacking the Invenia ABUS 2.0
Instructions and pry bar are provided in the materials attached to
the shipping crate.
There are two sizes of Invenia ABUS 2.0 package, one is
1715x845x1650mm and the other is 1167x905x1807mm.
Wear gloves to protect your hands from wood splinters or metal
edges.
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
1. Position the crate to allow room
at both narrow ends to unload
the Invenia ABUS 2.0.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
2. Locate the pry tool taped to one
of the sides of the crate.
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
3. Remove the top of the crate.
a. Use the pry tool to lift all
of the metal tabs along
the top of the crate.
b. Lift the crate top until it
clears the metal tabs, and
set aside.
NOTE: Ensure that the metal
tabs are straightened until they
are vertical, or the top will be
difficult to remove.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
4. Continue lifting the metal tabs
along the side of the crate to
remove all side panel.
NOTE: Straighten the bottom
tabs first, and then straighten
the tabs on the side panels.
Use caution when removing the
crate side panels.
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
5. Use a pair of scissors to remove
the clear plastic wrapping.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
6. Remove the waterproof foil.
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
7. Remove the accessories box
(membranes, lotion, network
cable, power cord, etc..)
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
8. Detach the orange safety strap
that secures the Invenia to the
crate base.
Ratchet Strap Release
Instructions:
a. To release, pull and hold
release tab on top
assembly to override
ratcheting function.
b. Open ratchet until it is
completely open and flat.
c. Grab webbing from
non-fixed side and pull to
release webbing.
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
9. Remove the ramps from both
sides of the Invenia ABUS 2.0.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
10. Unfold both ramps. Then attach
the ramps to the end of the
crate with the black hook and
loop straps.
CAUTION: Ensure
positioned with the white
bounding boards outside of the
black straps. These boards
keep the wheels on the ramp.
that the ramps are
3-18Invenia ABUS 2.0 – System Setup and Basic Service Manual
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
11. Unlock the caster wheels, and
then carefully move the Invenia
ABUS 2.0 down the ramp.
Invenia ABUS 2.0 – System Setup and Basic Service Manual3-19
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
12. Remove the Scan Arm
Assembly protective foam.
Then, use a pair of scissors to
cut the cable ties holding the
protective Display Monitor foam.
3-20Invenia ABUS 2.0 – System Setup and Basic Service Manual
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
13. Move up the Scan Arm
Assembly then remove the
Scan Arm Assembly and
Display monitor protective foam.
14. Remove the Tube Covers
protective foam.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
StepDescriptionIllustration
15. Remove the Service Table
protective foam.
16. Place the Scan Head Handle
into the Transport Ring on the
Articulating Display Arm.
WAR NIN G:
Secure the Scan Head
and Scan Arm PRIOR to
moving the Invenia
ABUS 2.0. Failure to do so may
cause the Scan Head and Scan
Arm to swing around the unit
and cause personal injury or
cause damage to the Scan
Head or other equipment.
17. Remove all of the packaging and place the removed packaging back into the crate to store for
possible future use.
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Receiving and Unpacking the Equipment
Table 3-4: Unpacking the Invenia ABUS 2.0 (for Size 1167x905x1807mm)
StepDescriptionIllustration
1. Position the crate to allow room
which have enough space to
unload the Invenia ABUS 2.0.
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System Setup
Table 3-4: Unpacking the Invenia ABUS 2.0 (for Size 1167x905x1807mm)
StepDescriptionIllustration
2. Unlock 4pcs Butterfly Lock,
open the package door and put
it down carefully.
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Receiving and Unpacking the Equipment
Table 3-4: Unpacking the Invenia ABUS 2.0 (for Size 1167x905x1807mm)
StepDescriptionIllustration
3. Detach the orange safety strap
that secures the two accessory
boxes to the crate base.
Ratchet Strap Release
Instructions:
a. To release, pull and hold
release tab on top
assembly to override
ratcheting function.
b. Open ratchet until it is
completely open and flat.
c. Grab webbing from
non-fixed side and pull to
release webbing.
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System Setup
Table 3-4: Unpacking the Invenia ABUS 2.0 (for Size 1167x905x1807mm)
StepDescriptionIllustration
4. Take out the accessory box.
3-26Invenia ABUS 2.0 – System Setup and Basic Service Manual
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