GE Invenia ABUS 2.0 Basic Service Manual_SM_4700-0043-00_4 Sealing Autoclave Doors

Page 1
Technical Publication

4700-0043-00

Rev. 4
InveniaTM ABUS 2.0
System Setup and Basic Service Manual
Operating Documentation
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Product Information
(CE
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. 1 2018-07-19 Initial release
Rev. 2 2019-01-04 Update package information and unpacking procedure
Rev. 3 2019-01-18 Update revision number
Rev. 4 2019-04-07 Update device label information
Pages Revision Pages Revision
Front Rev. 4 Chapter 6 Rev. 4
Front matter Rev. 4 Chapter 7 Rev. 4
TOC Rev. 4 Chapter 8 Rev. 4
Chapter 1 Rev. 4 Chapter 9 Rev. 4
(YYYY-MM-DD) Reason for change
List of Effected Pages (LOEP)
Chapter 2 Rev. 4 Chapter 10 Rev. 4
Chapter 3 Rev. 4 Index Rev. 4
Chapter 4 Rev. 4 Rear Cover Rev. 4
Chapter 5 Rev. 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.
All Material Copyright © 2018-2019 by General Electric Company Inc. All Rights Reserved.
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Translation policy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Damage in transportation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-15 Certified electrical contractor statement - For USA Only - - - - - - - - - - - - i-15 Omission and errors - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-16 Service Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-17 Legal notes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-18 Trademarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-18 Copyrights - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-18

Table of Contents

Chapter 1 — Introduction
Manual Overview
Contents in this manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Typical users of the System Setup and Basic Service Manual- - - - - - - - 1-3 Invenia ABUS 2.0 models covered by this manual - - - - - - - - - - - - - - - - 1-3
Instrument Overview
Invenia ABUS 2.0 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 View-on PACs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Important conventions
Conventions used in book - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Standard hazard icons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Standard Icons that indicate that a special procedure is to be used - - - 1-11 Product icons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Label locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12
Safety considerations
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13 Dangerous procedure warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-16 Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17 Mechanical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18
Electromagnetic compatibility (EMC)
What is EMC? - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Electrostatic discharge (ESD) prevention - - - - - - - - - - - - - - - - - - - - - 1-23
Customer assistance
Contact information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-24 Phone numbers for Customer Assistance - - - - - - - - - - - - - - - - - - - - - 1-25 System manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26
Returning parts
Returning the transducer and repair parts - - - - - - - - - - - - - - - - - - - - - 1-27
Table of Contents
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Chapter 2 — Site Preparations
General requirements
Invenia ABUS 2.0 environmental requirements - - - - - - - - - - - - - - - - - - 2-2 Electrical requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3
Facility needs
Purchaser responsibilities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Time and manpower requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Facility needs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
Networking setup requirements
Invenia ABUS 2.0 connected to hospital’s network- - - - - - - - - - - - - - - 2-16 Purpose of the DICOM network function - - - - - - - - - - - - - - - - - - - - - - 2-16 DICOM setup requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
Environmental Dangers
Patient Vicinity UL60601-1 (USA) - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19
Chapter 3 — System Setup
Setup Time and Warnings
Average setup time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Setup warnings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
Receiving and Unpacking the Equipment
Warnings for receiving and unpacking - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Receiving the Invenia ABUS 2.0- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Unpacking the Invenia ABUS 2.0 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9
Preparing for Setup
Verify customer order - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Physical inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 EMI protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Setup Warnings and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-40 Electrical specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Connections on the Rear Panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42 Switch ON the AC Power to Invenia ABUS 2.0 - - - - - - - - - - - - - - - - - 3-45 Power shut down - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45
Setting up the Invenia ABUS 2.0
Powering on the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Logging in as Admin - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Calibrating the Touch Screen Display - - - - - - - - - - - - - - - - - - - - - - - - 3-47 Entering Institution Name - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Setting up Time and Date Setting - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49 Setting up the Windows network - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Setting up Connectivity between Invenia ABUS 2.0 and destinations- - 3-55
Customizing the Invenia ABUS 2.0
General Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57 Scanning Protocols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-64 Worklist Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-65 Worklist Configuration (continued) - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66 Storage Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-67
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Service Configuration Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-68 About Page - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-69 Checking connections between the Invenia ABUS 2.0 and destinations 3-70
Paperwork after setup
User’s Manual(s) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-71 Product Locator Installation Card - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-72
Chapter 4 — Functional Checks
General procedures
General Precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Power ON/Boot Up - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Moving and Transporting the Invenia ABUS 2.0- - - - - - - - - - - - - - - - - - 4-7 Where are the User Manuals and the Service Manual? - - - - - - - - - - - 4-11
Functional checks
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 Performance Functional Checks- - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 Mechanical Functions Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 Connectivity Functional Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15
Chapter 5 — Components and Functions (Theory)
Introduction
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 General physical design of the ABUS 2.0 system- - - - - - - - - - - - - - - - - 5-5 Physical / mechanical main elements - - - - - - - - - - - - - - - - - - - - - - - - - 5-5
General theory of operation
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Image handling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Image file management - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-8 System elements and their operation - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 PC box - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11 Weight Tower - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Scan Arm Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Scan Head - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Display arm assembly with Touchscreen Monitor- - - - - - - - - - - - - - - - 5-23 Controls, displays, and ports - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24 Electrical / Electronic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27 Service-Related - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27
Chapter 6 — Service Adjustments and lubrication
Service Adjustments
Scan Head Drive Screw Damper Adjustment- - - - - - - - - - - - - - - - - - - - 6-3 Ball Joint Lubrication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4
Chapter 7 — Diagnostics/Troubleshooting
Service safety considerations Gathering troubleshooting data
Collecting a screen capture with logs - - - - - - - - - - - - - - - - - - - - - - - - - 7-3
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Service Desktop
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 Connecting to Service Desktop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Color status - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-6 Licenses - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 Basic Class Access- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Utilities- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-27
Troubleshooting and System Messages
Invenia ABUS 2.0 Troubleshooting and System Messages - - - - - - - - - 7-29 Invenia ABUS 2.0 Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-38
Invenia ABUS 2.0 Error Log
Daily error logs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-41 Collecting Error Logs- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-44 Common Error Codes for the Invenia ABUS 2.0 - - - - - - - - - - - - - - - - 7-45 Error Code Identifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-46 Error Code List - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-48
Chapter 8 — Replacement Procedures
Warnings and important information
Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Manpower - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Returning/shipping transducers and repair parts - - - - - - - - - - - - - - - - - 8-4
Parts Disposal
Used Media and Used Parts Disposal- - - - - - - - - - - - - - - - - - - - - - - - - 8-5
Cleaning the Filter / Replacement
Filter Replacement Functional Check - - - - - - - - - - - - - - - - - - - - - - - - - 8-7
Replacing the Transducer
Replacing the Transducer (continued) - - - - - - - - - - - - - - - - - - - - - - - 8-10 Transducer Functional Check - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 B-Mode Functional Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 3D Volume Functional Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 Performing the Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-12
Replacing the Power Cord System Backup and Software Load
Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-14
Internal Component Replacement
Chapter 9 — Renewal Parts
List of Abbreviations Reordering Supplies
Chapter 10 — Care and Maintenance
Why Do Maintenance?
Keeping Records - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 Customer Quality Assurance Program - - - - - - - - - - - - - - - - - - - - - - - 10-2
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Care and Maintenance Schedule Cleaning
Cleaning Scan Head Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6 Cleaning Air Filter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8
Index
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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 Number Chapter Title Description
1. Introduction Contains a content summary and warnings.
2. Site preparations Contains pre-setup requirements for the Invenia ABUS 2.0.
3. System Setup Contains setup procedure with procedure checklist.
4. General Procedures and Functional Checks
5. Components and Functions (Theory)
6. Service Adjustments Contains instructions on how to make any available adjustments
7. Diagnostics/ Troubleshooting
8. Replacement procedures Provides disassembly procedures and reassembly procedures
9. Renewal Parts Contains a list of replacement parts for Invenia ABUS 2.0.
10. Care & Maintenance Provides maintenance procedures for Invenia ABUS 2.0.
Index Index A 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
Number Description System SW Application SW
H5018SS Invenia ABUS 2.0, Global Windows Embedded Standard 7 64-bit Version 2.0.3 or later
H5018SC Invenia ABUS 2.0, China Windows Embedded Standard 7 64-bit Version 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 Electricity Tag and Lockout Wear Eye Protection
Hand Protection Foot Protection Wear 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 RULE DETAILS
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
Step Task
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.
Figure 3-1. Invenia ABUS 2.0 transportation box label
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Receiving and Unpacking the Equipment
Invenia ABUS 2.0 Transportation Box Label (continued)
Table 3-2: Package Label Icons
Label/Icon Purpose/Meaning Location
Keep this way up. Package
Fragile. Package
Keep it away from rain. Package
2 levels at most. Package
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System Setup
Label/Icon Purpose/Meaning Location
Table 3-2: Package Label Icons
Humidity Limitation Package
Temperature Limitation Package
Pressure Limitation Package
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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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
Step Description Illustration
11. Unlock the caster wheels, and then carefully move the Invenia ABUS 2.0 down the ramp.
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System Setup
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
Step Description Illustration
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.
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Receiving and Unpacking the Equipment
Table 3-3: Unpacking the Invenia ABUS 2.0 (for Size 1715x845x1650mm)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
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)
Step Description Illustration
4. Take out the accessory box.
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