Canon Omnera 500A User manual

Technical Publication:
Operator´s Manual
1000-095-071-EN Rev. 1.1

Disclaimer
The standard warranty is void if the product has been intentionally modified, or damaged by
accident, abuse or misuse. Additionally, this warranty is void if untrained personnel service
the OMNERA® 500A equipment.
Lost profits, downtime, goodwill, damage to or replacement of property, and any costs of
repairing the OMNERA® 500A resulting from a breach of warranty are not the responsibility
of Canon Medical Systems
Specifications are subject to change without notice. Not responsible for typographical errors.
Notices
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval
system or translated into any language or computer language, in any form or by any means,
electronic, mechanical, magnetic, optical, chemical, manual or otherwise, without the prior
written permission of Canon Medical Systems
Note: Photos and drawings used in this guide may be slightly different from the
actual product.
Dispose of electronic equipment in accordance with local, state, and federal
regulations.
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION AND SUCH INFORMATION
MAY NOT BE DISCLOSED TO OTHERS FOR ANY PURPOSE NOR USED FOR
MANUFACTURING PURPOSES WITHOUT WRITTEN PERMISSION FROM CANON
MEDICAL SYSTEMS.
Trademarks
OMNERA® is a registered trademarks of Canon Medical
Systems
All third-party brand names, product names, or logos
appearing in this manual are the trademarks or registered
trademarks of their respective owners.
Canon® is a registered trademark of Canon, Inc. and may
also be a registered trademark or a trademark in other
countries.

Revision history Chapter/Pages Rev Date
New Release 1.1 2020-09

Contents
1 Introduction ...............................................................................................1
1.1 Document information....................................................................................1
1.1.1 System documentation ............................................................................1
1.1.2 Stylistic conventions................................................................................1
1.1.3 Document producer.................................................................................1
1.1.4 Copyright © 2020 Arcoma Corporation all rights reserved...........................1
1.1.5 Text emphasis.........................................................................................1
1.2 Identification Labels .......................................................................................3
1.3 System Description........................................................................................6
1.3.1 General ..................................................................................................6
1.3.2 Intended Use ..........................................................................................6
1.3.3 Configuration ..........................................................................................6
1.3.4 System Overview ....................................................................................7
1.3.5 Overhead Tube Crane, overview ..............................................................8
1.3.6 Table overview........................................................................................9
1.3.7 Wall stand Overview..............................................................................10
2 Safety ..........................................................................................................11
2.1 Compliance................................................................................................. 11
2.2 Precautions, safety ......................................................................................12
2.3 Qualifications of Personnel ...........................................................................15
2.3.1 Operating Personnel .............................................................................15
2.3.2 Service Personnel.................................................................................15
2.4 Service and Maintenance .............................................................................16
2.4.1 Operation, Installation and Repair ..........................................................16
2.5 Installation and repair...................................................................................18
2.6 Safety and Warning Symbols........................................................................19
2.7 Safety and Warning Labels on the Equipment ................................................20
2.8 Applied Parts...............................................................................................21
2.9 Emergency stop...........................................................................................22
2.10 Radiation and X-ray tube..............................................................................23
2.10.1 Radiation protection ..............................................................................24
2.11 Mechanical safety........................................................................................29
2.11.1 General ................................................................................................29
2.11.2 Overhead tube crane.............................................................................30
2.11.3 Cabinet ................................................................................................32
2.11.4 Table....................................................................................................33
2.11.5 Wall stand ............................................................................................39
2.12 Safety functions...........................................................................................41
2.12.1 System.................................................................................................41
2.13 Safety zone, definition..................................................................................47
2.13.1 Table Safety zone .................................................................................47
2.13.2 Two column table .................................................................................47
2.14 Electromagnetic compatibility (EMC) .............................................................48
3 User Interface ........................................................................................ 55
3.1 Overhead Tube Crane..................................................................................55
3.1.1 Direction of Movement...........................................................................55
3.1.2 Sound Signal ........................................................................................55
3.1.3 System Display Overview ......................................................................56
3.2 Automatic Collimator Control ........................................................................57
3.2.1 Automatic collimator ..............................................................................58
3.2.2 Display user interface ............................................................................61
3.2.3 Patient Information ................................................................................62
3.2.4 Position Information ..............................................................................62
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Contents
3.2.5 Adjustment of Generator Parameters (kV, mA, ms, mAs, Density).............63
3.2.6 Settings................................................................................................63
3.2.7 System Mode........................................................................................70
3.2.8 Hospital manual ....................................................................................75
3.2.9 Selection of Technique Mode .................................................................76
3.2.10 Patient Size ..........................................................................................78
3.2.11 Collimator Centering..............................................................................79
3.2.12 Servo State Mode .................................................................................80
3.2.13 Grid Status ...........................................................................................81
3.2.14 Light indication......................................................................................83
3.3 Exposure ....................................................................................................84
3.3.1 Exposure Hand Control .........................................................................84
3.3.2 Exposure Index.....................................................................................84
3.3.3 Deviation Index .....................................................................................84
3.4 Image System .............................................................................................85
3.5 Remote control (option)................................................................................86
3.6 Servo Button ...............................................................................................88
3.6.1 External Servo Button Module................................................................88
3.6.2 Indication Light......................................................................................88
3.6.3 DAP ....................................................................................................88
3.7 Table Control elements.................................................................................89
3.7.1 Directions of Movement .........................................................................89
3.7.2 Power Indication ...................................................................................89
3.7.3 Foot Control, Table X/Y/Z (option) ..........................................................90
3.7.4 Foot control, wireless (option) ................................................................90
3.7.5 XY Foot Control, Strip Type (Option) .......................................................92
3.7.6 Table Hand Control ...............................................................................92
3.7.7 Moving Table Top..................................................................................94
3.7.8 Vertical Travel Safety (option).................................................................94
3.7.9 Attach/Remove Accessories ..................................................................95
3.7.10 Motorized Imaging Unit Movement .........................................................95
3.8 Wall stand Control Elements.........................................................................97
3.8.1 Wall stand Controls ...............................................................................97
4 Operating the System......................................................................101
4.1 General.....................................................................................................101
4.1.1 Applied Parts ......................................................................................101
4.2 Turn on the system ....................................................................................102
4.3 Turn off the system ....................................................................................104
4.4 Perform examination..................................................................................106
4.4.1 Select patient......................................................................................106
4.4.2 Start examination ................................................................................ 107
4.4.3 Position the system .............................................................................108
4.4.4 Adjust position and collimator for chosen examination and
patient .........................................................................................108
4.4.5 Exposure............................................................................................109
4.4.6 Review image ..................................................................................... 111
4.4.7 Change work space............................................................................. 111
4.4.8 Basic exposure error handling.............................................................. 113
4.5 Movement Short-cut Zones......................................................................... 114
4.5.1 Wallstand Short-cut Zone .................................................................... 115
4.5.2 Table Short-cut Zone ........................................................................... 115
4.6 Transport Interval Zone .............................................................................. 116
4.7 Manual Mode ............................................................................................ 117
4.7.1 Activation of Manual Mode................................................................... 117
4.8 Free Examination Procedures..................................................................... 119
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Contents
4.8.1 Free Mode.......................................................................................... 119
4.8.2 Auto Position Mode ............................................................................. 119
4.9 X-ray Table Examination Procedures...........................................................121
4.9.1 Table Flexible Mode ............................................................................121
4.9.2 Film Tracking Mode .............................................................................122
4.9.3 Pendulum Mode..................................................................................123
4.9.4 Stitching Table Mode (Option) .............................................................. 123
4.10 Wallstand Examination Procedures ............................................................. 126
4.10.1 Wall Flexible Modes ............................................................................126
4.10.2 NoWait Configuration ..........................................................................128
4.10.3 Stitching Wall Stand Mode ................................................................... 128
4.10.4 AEC Technique Setup .........................................................................130
4.11 Detector, Wallstand....................................................................................131
4.11.1 14x17 Detector, Wallstand ................................................................... 132
4.11.2 17x17 Detector, Wallstand ................................................................... 136
4.12 Portable detector, table ..............................................................................139
4.12.1 Set the detector...................................................................................139
4.12.2 Change between portrait and landscape ............................................... 141
4.12.3 Remove detector.................................................................................142
4.12.4 Exchange grid.....................................................................................143
5 Error Handling.....................................................................................145
5.1 Fault Handling ...........................................................................................145
5.1.1 Notifications........................................................................................145
5.2 Diagnostic.................................................................................................149
6 Cleaning..................................................................................................151
6.1 General.....................................................................................................151
6.2 Collimator..................................................................................................152
6.3 Wall stand, Table, OTC and X-ray Tube ....................................................... 153
7 Function and safety checks.........................................................155
7.1 Monthly Checks.........................................................................................155
7.1.1 General ..............................................................................................155
7.1.2 OTC...................................................................................................155
7.1.3 Table..................................................................................................155
7.1.4 Wall stand ..........................................................................................155
8 Technical specification...................................................................157
8.1 Electrical Characteristics ............................................................................157
8.2 Environmental Requirements...................................................................... 158
8.3 Ceiling suspended X-ray tube support ......................................................... 159
8.3.1 General ..............................................................................................159
8.3.2 Configuration ......................................................................................159
8.3.3 Weight................................................................................................159
8.3.4 Electrical Characteristics ..................................................................... 159
8.3.5 Classification ......................................................................................159
8.3.6 Speed ................................................................................................160
8.4 Cabinet .....................................................................................................161
8.4.1 Dimensions ........................................................................................161
8.4.2 Weight................................................................................................161
8.5 Table.........................................................................................................162
8.5.1 Column ..............................................................................................162
8.5.2 Table Top............................................................................................162
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Contents
8.5.3 Weight................................................................................................162
8.5.4 Electrical Characteristics ..................................................................... 162
8.5.5 Attenuation Equivalent.........................................................................162
8.6 Wall stand .................................................................................................163
8.6.1 Attenuation equivalent .........................................................................163
8.6.2 Weight................................................................................................163
8.6.3 Speed ................................................................................................163
9 Waste Disposal ...................................................................................165
10 Accessories..........................................................................................167
10.1 General.....................................................................................................167
10.1.1 Table..................................................................................................167
10.1.2 Wallstand ...........................................................................................168
10.1.3 Detector .............................................................................................168
10.1.4 Grid....................................................................................................168
11 Appendix A............................................................................................169
11.1 Glossary ...................................................................................................169
12 Appendix B............................................................................................173
12.1 Monthly Checklist.......................................................................................173
12.1.1 OTC...................................................................................................173
12.1.2 Remark ..............................................................................................176
12.2 Annual Checks ..........................................................................................177
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Operator´s Manual 1000-095-071-EN Rev. 1.1 OMNERA®
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1 Introduction
1.1 Document information
• It is important to keep this document for the life of the equipment, and pass the document
on to any subsequent holder or user of the equipment.
• The original version of this manual is written in English.
• Training is provided by or via Arcoma. Training material consists of the Operation manual
and the Installation and service manual.
1.1.1 System documentation
The following documentation is available for the system:
• Installation and service manual
• Operation manual
• Planning guide
1.1.2 Stylistic conventions
All warning label texts are shown in italic style in this manual.
All references are shown in italic style in this manual.
1.1.3 Document producer
This document has been produced by:
Arcoma AB
Annavägen 1
S–352 46 VÄXJÖ,
Sweden
www.arcoma.se
1.1.4 Copyright © 2020 Arcoma Corporation all rights reserved
The reproduction, transmission or use of this document or its content is not permitted without
express written authority. Offered will be liable for damages. All rights, including rights cre-
ated by patent grant or registration of a utility model or design, are reserved.
1.1.5 Text emphasis
WARNING!
All texts labelled with “WARNING” call attention to potential risk to health or life.
CAUTION!
All texts labelled with “CAUTION” contain information about dangerous situations
and measures to avoid risk.
Introduction
Document information

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Note!
All texts labelled with “NOTE” contain additional information regarding the work step, and is
provided for a better understanding or as a warning about unnecessary and avoidable
difficulties.
Introduction
Document information

Operator´s Manual 1000-095-071-EN Rev. 1.1 OMNERA®
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1.2 Identification Labels
The figure shows the location of the identification labels on the equipment.
1000
1
2
3
3
44 5
76
510 311
15
16
12
13
14
4007-01
Fig. 1-1
Introduction
Identification Labels

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1 10
2 11
3 12
413
5
14
Introduction
Identification Labels

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6 15
4041
1000
4102
OMNERA 500A
716
1000
Introduction
Identification Labels

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1.3 System Description
1.3.1 General
Arcoma Precision includes:
• Overhead tube crane (OTC) with x-ray tube and collimator
• Table
• Wall stand
• System cabinet with a high voltage generator
• Image Acquisition system
• Flat panel detectors
1.3.2 Intended Use
The system is a stationary X-ray system intended for obtaining radiographic images of vari-
ous portions of the human body in a clinical environment.
The system is not intended for mammography.
1.3.3 Configuration
The basic system consists of system Cabinet (including generator), Image acquisition sys-
tem, Flat panel detectors, and Overhead tube crane. The basic system can be equipped with
one of the following three configurations:
• Table and Wall Stand
• Wall Stand
• Table
Introduction
System Description

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1.3.4 System Overview
1
5
3
2
36
4
4008-01
Fig. 1-2 System Overview
1. Overhead tube crane, OTC
2. Table
3. Detector holder
4. Wall stand
5. System cabinet
6. Computer and monitor
Introduction
System Description

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1.3.5 Overhead Tube Crane, overview
Z
Y
X
0
124
7
3
68
5
4072
Fig. 1-3 Overhead Tube Crane, OTC
1. Ceiling rail (Y)
2. Traverse rail (X)
3. Ceiling wagon
4. Column (Z)
5. X-ray tube
6. Manoeuvre handle
7. Collimator
8. Display
Introduction
System Description

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1.3.6 Table overview
002003-01
10
11
1
2
3
Z
Y
X
0
6
4
9
57
8
Fig. 1-4 Table overview
1. Foot plate
2. Column
3. Table top
4. Table hand control (X/Y/Z, Ceiling
tube pendulum movement)
5. Detector holder
6. Brake release for detector holder
7. XY foot control strip type (Option)
8. Foot control table top (X/Y/Z)
(Option)
9. Collimator hand control (option)
10.Head end
11. Foot end
Introduction
System Description

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1.3.7 Wall stand Overview
Z
T
2
1
53
4
2004-06
Fig. 1-5 Wall stand overview, T = Tilt
1. Lateral armrest
2. Detector holder
3. Column
4. Foot plate
5. Hand control
(Collimator and movement
adjustments)
Introduction
System Description

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2 Safety
2.1 Compliance
External equipment intended for connection to signal input, signal output or other connectors
shall comply with the relevant product standard e.g. IEC 60950–1 for IT equipment and the
IEC 60601–series for medical electrical equipment.
In addition, all such combinations – systems – shall comply with the safety requirements sta-
ted in the collateral standard IEC 60601–1–1 or the general standard IEC 60601–1, edition
3.1, clause 16. Any equipment not complying with the leakage current requirements in IEC
60601–1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient
support.
Any person who connects external equipment to signal input, signal output or other connec-
tors has formed a system and is therefore responsible for the system to comply with the
requirements.
If in doubt, contact qualified medical technician or your local representative.
If external equipment is connected, an isolation device is needed to isolate the equipment lo-
cated outside the patient environment from the equipment located inside the patient environ-
ment. In particular such a separation device is required when a network connection is made.
The requirements on the separation device is defined in IEC 60601–1–1 and in IEC 60601–
1, edition 3.1, clause 16.
Safety
Compliance

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2.2 Precautions, safety
WARNING!
No modification of this equipment is allowed.
WARNING!
The equipment is intended for use in radiographic examinations under the guidance
of trained health care professionals. Operating personnel must be familiar with the
equipment and the instructions given in this manual before using the equipment.
WARNING!
Safety devices must not be removed or modified. Any modification or removal will im-
mediately impair the safety.
WARNING!
All motorized movements shall be supervised by trained personnel.
WARNING!
Do not use non-medical electrical devices in the X-ray room.
CAUTION!
Do not use any flammable or explosive gases near the device.
CAUTION!
Before using this device, read the manuals supplied with the devices in order to
understand functions, operation, and performance. Follow the manuals for correct
procedures.
CAUTION!
Before using the device again after a longer period of time, check the correct opera-
tion of the system.
Safety
Precautions, safety