Canon Omnera 500A User manual

Technical Publication:
Operator´s Manual
1000-095-071-EN Rev. 2.1

Disclaimer
The standard warranty is void if the system 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 system.
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.

Rev Date
New release 1.1 2020-09
1.2 Identification Labels updated
Updated 6 Cleaning and Disinfection to
Added warning from 6 Cleaning and Disinfection to
2.2 Precautions, Safety
Added 8 Complying Standards
Added AEC Accuracy in table Output Parameter and
Loading Factor in 9.3 Radiographic Specification
Added 9.4 Collimator
Added 9.5 X-ray Tube
2.1 2021–06

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 © 2021 Arcoma Corporation All Rights Reserved........................1
1.1.5 Text Emphasis ........................................................................................2
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 Wallstand 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
2.5 Installation and Repair..................................................................................17
2.6 Safety and Warning Symbols........................................................................18
2.7 Safety and Warning Labels on the Equipment ................................................19
2.8 Applied Parts...............................................................................................20
2.9 Essential Performance and Basic Safety .......................................................21
2.10 Emergency Stop..........................................................................................22
2.11 Radiation and X-Ray Tube............................................................................23
2.11.1 Radiation Protection ..............................................................................24
2.12 Mechanical Safety .......................................................................................29
2.12.1 General ................................................................................................29
2.12.2 Overhead Tube Crane ...........................................................................30
2.12.3 Cabinet ................................................................................................31
2.12.4 Table....................................................................................................32
2.12.5 Wallstand .............................................................................................38
2.13 Safety Functions..........................................................................................40
2.13.1 Table Safety Zone and Overhead Tube Crane .........................................40
2.13.2 Wallstand Safety Zone...........................................................................40
2.13.3 Collision Detection ................................................................................40
2.13.4 Dead Man’s Grip ...................................................................................41
2.14 Electromagnetic Compatibility (EMC) ............................................................42
3 User Interface ........................................................................................ 45
3.1 Overhead Tube Crane..................................................................................45
3.1.1 Direction of Movement...........................................................................45
3.1.2 Sound Signal ........................................................................................45
3.1.3 System Display Overview ......................................................................46
3.2 Automatic Collimator Control ........................................................................47
3.2.1 Automatic Collimator .............................................................................47
3.3 Display User Interface..................................................................................51
3.3.1 Patient Information ................................................................................52
3.3.2 Position Information ..............................................................................52
Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page i

Contents
3.3.3 Adjustment of Generator Parameters (kV, mA, ms, mAs, Density).............53
3.3.4 Settings................................................................................................54
3.3.5 System Mode........................................................................................61
3.3.6 Hospital method book............................................................................66
3.3.7 Selection of Technique Mode .................................................................67
3.3.8 Patient Size ..........................................................................................69
3.3.9 Collimator Centering..............................................................................70
3.3.10 Servo State Mode .................................................................................71
3.3.11 Grid Status ...........................................................................................72
3.3.12 Light Indication......................................................................................74
3.4 Exposure ....................................................................................................75
3.4.1 Exposure Hand Control .........................................................................75
3.4.2 Exposure Index.....................................................................................75
3.4.3 Deviation Index .....................................................................................75
3.5 Image System .............................................................................................76
3.6 Remote Control (option) ...............................................................................77
3.7 Servo Button ...............................................................................................79
3.7.1 External Servo Button Module................................................................79
3.7.2 Indication Light......................................................................................79
3.7.3 DAP ....................................................................................................79
3.8 Table Control elements.................................................................................80
3.8.1 Directions of Movement .........................................................................80
3.8.2 Power Indication ...................................................................................80
3.8.3 Foot Control, Table X/Y/Z (option) ..........................................................80
3.8.4 Foot Control, Wireless (option) ...............................................................81
3.8.5 XY Foot Control, Strip Type (Option) .......................................................82
3.8.6 Table Hand Control ...............................................................................83
3.8.7 Moving Table Top..................................................................................84
3.8.8 Vertical Travel Safety (option).................................................................84
3.8.9 Attach/Remove Accessories ..................................................................85
3.8.10 Motorized Imaging Unit Movement .........................................................86
3.9 Wallstand Control Elements..........................................................................87
3.9.1 Wallstand Controls ................................................................................87
4 Operating the System........................................................................ 91
4.1 Turn On The System....................................................................................91
4.2 Turn Off The System ....................................................................................93
4.3 Perform Examination ...................................................................................95
4.3.1 Select Patient .......................................................................................95
4.3.2 Start Examination..................................................................................96
4.3.3 Position The System .............................................................................97
4.3.4 Adjust Position And Collimator For Chosen Examination And
Patient...........................................................................................97
4.3.5 Exposure..............................................................................................98
4.3.6 Review Image.......................................................................................99
4.3.7 Change Work Space ...........................................................................100
4.3.8 Basic Exposure Error Handling............................................................. 101
4.4 Movement Short-Cut Zones........................................................................102
4.4.1 Wallstand Short-Cut Zone.................................................................... 102
4.4.2 Table Short-Cut Zone ..........................................................................102
4.5 Transport Interval Zone ..............................................................................103
4.6 Manual Mode ............................................................................................104
4.6.1 Activation of Manual Mode ................................................................... 104
4.7 Free Examination Procedures..................................................................... 106
4.7.1 Free Mode..........................................................................................106
4.7.2 Auto Position Mode .............................................................................106
OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page ii

Contents
4.8 X-ray Table Examination Procedures........................................................... 108
4.8.1 Table Flexible Mode ............................................................................108
4.8.2 Film Tracking Mode .............................................................................109
4.8.3 Pendulum Mode.................................................................................. 110
4.8.4 Stitching Table Mode (Option) .............................................................. 111
4.9 Wallstand Examination Procedures............................................................. 113
4.9.1 Wall Flexible Modes ............................................................................ 113
4.9.2 NoWait Configuration .......................................................................... 115
4.9.3 Stitching Wallstand Mode (option) ........................................................ 116
4.9.4 AEC Technique Setup ......................................................................... 117
4.10 Detector, Wallstand.................................................................................... 118
4.10.1 14x17 inches Detector, Wallstand......................................................... 119
4.10.2 17x17 inches Detector, Wallstand......................................................... 123
4.11 Portable detector, table ..............................................................................125
4.11.1 Set the detector...................................................................................125
4.11.2 Change Between Portrait and Landscape ............................................. 127
4.11.3 Remove detector.................................................................................128
4.11.4 Exchange Grid....................................................................................129
5 Error Handling.....................................................................................131
5.1 Fault Handling ...........................................................................................131
5.1.1 Notifications........................................................................................131
5.2 Diagnostic.................................................................................................133
6 Cleaning and Disinfection ............................................................135
6.1 General.....................................................................................................135
6.1.1 Cleaning and Disinfection Permitted with System Switched ON .............. 135
6.2 Cleaning ...................................................................................................136
6.3 Disinfection ...............................................................................................137
6.4 Maneuver Handle and Display ....................................................................138
7 Function And Safety Checks.......................................................139
7.1 AEC Functional Check ...............................................................................139
7.2 Monthly Checks.........................................................................................140
7.2.1 General ..............................................................................................140
7.2.2 Overhead Tube Crane .........................................................................140
7.2.3 Table..................................................................................................140
7.2.4 Wallstand ...........................................................................................140
8 Complying Standards .....................................................................141
9 Technical specification...................................................................143
9.1 Power requirements...................................................................................143
9.2 Power line requirements ............................................................................144
9.3 Radiographic Specification ........................................................................145
9.4 Collimator..................................................................................................147
9.5 X-ray Tube ................................................................................................148
9.6 Environmental Requirements...................................................................... 149
9.7 Ceiling Suspended X-Ray Tube Support......................................................150
9.7.1 General ..............................................................................................150
9.7.2 Configuration ......................................................................................150
9.7.3 Weight................................................................................................150
9.7.4 Electrical Characteristics ..................................................................... 150
Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page iii

Contents
9.7.5 Classification ......................................................................................150
9.7.6 Speed ................................................................................................151
9.8 Cabinet .....................................................................................................152
9.9 Table.........................................................................................................153
9.9.1 Column ..............................................................................................153
9.9.2 Table Top............................................................................................153
9.9.3 Weight................................................................................................153
9.9.4 Electrical Characteristics ..................................................................... 153
9.9.5 Attenuation Equivalent.........................................................................153
9.10 Wallstand..................................................................................................154
10 Waste Disposal ...................................................................................155
11 Accessories..........................................................................................157
11.1 General.....................................................................................................157
11.1.1 General Accessories ...........................................................................157
11.1.2 Table..................................................................................................157
11.1.3 Wallstand ...........................................................................................158
11.1.4 Detector .............................................................................................158
11.1.5 Grid....................................................................................................158
12 Appendix A............................................................................................159
12.1 Glossary ...................................................................................................159
13 Appendix B............................................................................................163
13.1 Monthly Checklist.......................................................................................163
13.1.1 Overhead Tube Crane .........................................................................163
13.1.2 Remark ..............................................................................................165
13.2 Annual Checks ..........................................................................................166
OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page iv

Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page 1
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 Canon Medical Systems. Training material consists of the
Operator’s Manual and the Installation and service manual.
1.1.1 System Documentation
The following documentation is available for the system:
• Omnera 500A System installation and service manual
• Omnera 500A System operation manual
• Omnera 500A System planning guide
• Image system service manual
• Image system user manual
• Detector user’s manual
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 © 2021 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
created by patent grant or registration of a utility model or design, are reserved.
Introduction
Document Information

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 2
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.
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. 2.1 OMNERA 500A
Page 3
1.2 Identification Labels
The figure shows the location of the identification labels on the equipment.
1000
1
2
3
3
44 5
76
5839
13
14
10
11
12
4007-02
OMNERA 500A
Fig. 1-1 Location of identification labels
Label 13 and label 14 apply for US market only.
Introduction
Identification Labels

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 4
1 8
2 9
3 10
OMNERA 500A
411
5
12
6 13
4041
1000
US only
Introduction
Identification Labels

Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page 5
714
1000
US only
Introduction
Identification Labels

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 6
1.3 System Description
1.3.1 General
Omnera 500A includes:
• Overhead tube crane (OTC) with x-ray tube and collimator
• Table
• Wallstand
• 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
various 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
system, Flat panel detectors, and Overhead tube crane. The basic system can be equipped
with one of the following three configurations:
• Table and Wallstand
• Wallstand
• Table
1.3.3.1 Table Models and Designs
The table is prepared for different types of detectors, fixed or portable in different sizes.
1.3.3.2 Wallstand Models and Designs
The wallstand has different options:
• Tiltable detector holder wagon.
• Motorized Z movement
• Prepared for different types of detectors; fixed or portable in different sizes.
• The detector holder for the portable detector is available for either left-hand or right-hand
loading.
Introduction
System Description

Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page 7
1.3.4 System Overview
1
5
3
2
36
4
4008-01
B
E
F
D
A
C
C
Fig. 1-2 System Overview
A Overhead tube crane
B Table
C Detector holder
D Wallstand
E System cabinet
F Computer and monitor
Introduction
System Description

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 8
1.3.5 Overhead Tube Crane, Overview
Z
Y
X
0
AB
D
G
C
F
H
E
4072-04
Fig. 1-3 Overhead Tube Crane
A Ceiling rail Y
B Traverse X
C Ceiling wagon
D Column (Z)
E X-ray tube
F Maneuver handle
G Collimator
H Display
Introduction
System Description

Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page 9
1.3.6 Table Overview
002003-02
J
K
A
B
C
Z
Y
X
0
F
D
I
EG
H
Fig. 1-4 Table overview
A Foot plate
B Column
C Table top
D Table hand control (X/Y/Z, Ceiling
tube pendulum movement)
E Detector holder
F Brake release for detector holder
G XY foot control strip type (Option)
H Foot control table top (X/Y/Z)
(Option)
I Collimator hand control (option)
J Head end
K Foot end
Introduction
System Description

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 10
1.3.7 Wallstand Overview
Z
T
B
A
EC
D
2004-10
Fig. 1-5 Wallstand overview
Wallstand with tilt option
T= Tilt
With non-tilt detector (standard)
A. Lateral armrest
B. Detector holder
C. Column
D. Foot plate
E. Hand control
(Collimator and movement
adjustments)
Introduction
System Description

Operator´s Manual 1000-095-071-EN Rev. 2.1 OMNERA 500A
Page 11
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
stated in 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
connectors 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
located outside the patient environment from the equipment located inside the patient
environment. 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, edition 3.1,
clause 16.
Safety
Compliance

OMNERA 500A 1000-095-071-EN Rev. 2.1 Operator´s Manual
Page 12
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
immediately impair the safety.
WARNING!
All motorized movements shall be supervised by trained personnel.
WARNING!
Only medical-approved products shall be in the X-ray room.
Risk of electric shock to patient or user.
• No non-medical electrical devices shall be used in the x-ray room.
• Note that the monitor and the PC for the Image system, are non-medical approved
products.
WARNING!
Risk of electrical hazard or damage to the system
• Before cleaning or disinfection, switch off the system to prevent electric shocks,
for exceptions see
6.1.1 Cleaning and Disinfection Permitted with System Switched ON.
• Do not spray or pour cleaning liquid on any part of the system.
Use a lint-free cloth moistened with a moderate amount of liquid to avoid that
cleaning liquids seep into the openings of the system, e.g., air openings, gaps
between covers.
• Do not restart the system if cleaning liquids have leaked in.
Safety
Precautions, Safety