Canon OMNERA 400T User manual

Technical Publication:
Operator´s Manual
0180-095-418-EN Rev. 6.1

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® 400T equipment.
Lost profits, downtime, goodwill, damage to or replacement of property, and any costs of
repairing the OMNERA® 400T 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 trademark 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 6.1 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 Text emphasis.........................................................................................1
1.2 Identification Labels .......................................................................................2
1.3 System description ........................................................................................4
1.3.1 Intended use...........................................................................................4
1.3.2 System Overview ....................................................................................4
1.3.3 Overhead Tube Crane Overview ..............................................................5
1.3.4 0181 Closed Table 0181 Overview ...........................................................6
1.3.5 0055 Two Column Table 0055 Overview ...................................................7
1.3.6 Wall Stand Overview ...............................................................................8
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 Emergency Stop..........................................................................................20
2.9 Radiation and X-ray Tube.............................................................................21
2.10 Mechanical Safety .......................................................................................22
2.10.1 General ................................................................................................22
2.10.2 OTC, Mechanical Safety........................................................................22
2.10.3 Mechanical Safety, Table .......................................................................24
2.10.4 Working area, Table 0055 ......................................................................31
2.10.5 Mechanical Safety, Wall Stand ...............................................................32
2.11 Safety Functions..........................................................................................33
2.11.1 System.................................................................................................33
2.12 Safety Zone, Definition.................................................................................36
2.12.1 Safety Zone, Table ...............................................................................36
2.12.2 Safety Zone, Wall stand.........................................................................37
2.13 Electromagnetic Compatibility (EMC) ............................................................38
3 User Interfaces...................................................................................... 43
3.1 Description..................................................................................................43
3.2 Overhead tube crane ...................................................................................44
3.3 Patient information.......................................................................................46
3.4 Position information .....................................................................................47
3.5 Workstation modes ......................................................................................48
3.5.1 Automatic tracking activation..................................................................49
3.6 Adjustment of generator parameters (kV, mA, ms, mAs, density) .....................50
3.7 Selection of technique mode.........................................................................51
3.7.1 Selection of active AEC Field (AEC mode only) .......................................52
3.8 Patient size .................................................................................................53
3.9 Collimator centering.....................................................................................54
3.10 Hospital manual...........................................................................................55
3.11 Settings ......................................................................................................56
3.11.1 User settings.........................................................................................56
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Contents
3.11.2 Service.................................................................................................61
3.12 Wall Stand Control Elements ........................................................................64
3.12.1 Tiltable imaging unit holder (option) ........................................................64
3.12.2 Wall stand controls................................................................................65
3.13 Ceiling stand control elements ......................................................................67
3.13.1 Direction of movement...........................................................................67
3.14 Manual collimator.........................................................................................68
3.15 Automatic collimator (option) ........................................................................69
3.15.1 General ................................................................................................69
3.15.2 Basic flow of operation...........................................................................69
3.15.3 Display and control elements .................................................................70
3.16 Table control elements .................................................................................75
3.16.1 Directions of movement .........................................................................75
3.16.2 Power indication ...................................................................................75
3.16.3 Foot control, table X/Y/Z (option) ............................................................75
3.16.4 XY foot control, strip type (option) ...........................................................76
3.16.5 Table hand control.................................................................................77
3.16.6 Moving table top....................................................................................77
4 Operating the system........................................................................ 79
4.1 General.......................................................................................................79
4.2 Applied parts ...............................................................................................81
4.3 Turning on/off the system .............................................................................82
4.3.1 General ................................................................................................82
4.3.2 Turn on the system................................................................................82
4.3.3 Turn off the system................................................................................83
4.3.4 Workstation indication light ....................................................................83
4.3.5 System techniques................................................................................84
4.4 Operating the Table......................................................................................91
4.4.1 General ................................................................................................91
4.4.2 Functional description, closed table 0181................................................91
4.4.3 Detector - Canon CXDI-401 (Standard)...................................................94
4.4.4 14x17 Detector, table.............................................................................95
4.4.5 17x17 Detector, Table............................................................................97
4.4.6 Grid......................................................................................................99
4.4.7 Attach and remove table accessories.................................................... 102
4.5 Operating the Wall Stand............................................................................103
4.5.1 General ..............................................................................................103
4.5.2 Functional description..........................................................................104
4.6 Synchronization control/tracking ................................................................. 117
4.7 Exposure .................................................................................................. 118
4.7.1 Exposure Hand Control (option) ........................................................... 118
5 Error Handling.....................................................................................119
5.1 Fault handling............................................................................................ 119
5.1.1 Notifications........................................................................................ 119
6 Cleaning..................................................................................................123
6.1 General.....................................................................................................123
6.2 Collimator..................................................................................................124
6.3 X-ray tube .................................................................................................125
6.4 Ceiling suspended X-ray tube support .........................................................126
6.5 Table.........................................................................................................127
6.6 Wall stand .................................................................................................128
OMNERA® 0180-095-418-EN Rev. 6.1 Operator´s Manual
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Contents
7 Function and Safety Checks .......................................................129
7.1 Safety checks............................................................................................129
7.1.1 General ..............................................................................................129
7.1.2 Maintenance.......................................................................................129
7.1.3 Scheduled checks for the user ............................................................. 129
7.2 Monthly checks..........................................................................................130
7.2.1 Checklist ............................................................................................130
7.3 Annual checks...........................................................................................132
8 Technical Specifications................................................................133
8.1 400T System .............................................................................................133
8.1.1 Electrical characteristics ...................................................................... 133
8.1.2 Environmental requirements ................................................................ 135
8.1.3 OTC...................................................................................................135
8.1.4 Cabinet ..............................................................................................136
8.1.5 Wall stand ..........................................................................................136
8.1.6 Closed table 0181 ...............................................................................137
8.1.7 Two column table 0055 (option)............................................................ 138
9 Waste disposal....................................................................................139
10 Accessories and options...............................................................141
10.1 General.....................................................................................................141
10.2 Options for the system, with Canon image system .......................................142
10.2.1 Ceiling Suspended X-ray Tube Support, Canon US ............................... 142
10.2.2 Options for Table.................................................................................142
10.2.3 Options for Wall Stand.........................................................................143
10.2.4 Detectors............................................................................................143
10.2.5 System cabinet ...................................................................................144
10.2.6 Other options ......................................................................................144
10.2.7 Canon integration................................................................................144
10.3 Accessories...............................................................................................147
11 Appendix A............................................................................................149
11.1 Glossary ...................................................................................................149
12 Appendix B............................................................................................153
12.1 Monthly Checklist.......................................................................................153
12.1.1 General ..............................................................................................153
12.1.2 Ceiling Suspended X-ray Tube Support ................................................ 153
12.1.3 Table..................................................................................................154
12.1.4 Wall stand ..........................................................................................154
12.1.5 Remark ..............................................................................................155
12.2 Annual Checks ..........................................................................................156
Operator´s Manual 0180-095-418-EN Rev. 6.1 OMNERA®
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Contents
OMNERA® 0180-095-418-EN Rev. 6.1 Operator´s Manual
Page iv 2020-09-18

Operator´s Manual 0180-095-418-EN Rev. 6.1 OMNERA®
2020-09-18 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 was written in the English language.
Training is provided by Arcoma AB. Training material is the Operation manual and the Instal-
lation and service manual.
1.1.1 System documentation
The following documentation is available for the system:
• OMNERATM 400T Planning guide
• OMNERATM 400T Installation and service manual
• OMNERATM 400T Operator´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 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

OMNERA® 0180-095-418-EN Rev. 6.1 Operator´s Manual
Page 2 2020-09-18
1.2 Identification Labels
The figure shows the location of the identification labels on the equipment.
400 3~VAC
400 3~N VAC
480 3~VAC
Model: 0180 SC
SN XXXX
MM/YYYY
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
Model: 0180
SN XXXX
Power rating:
Intermittent operation: 20% 1min ON / 4min OFF
MM/YYYY
Type: X-ray System
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0175
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETYACT OF 1968.
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0413
Model: 0170CS
SN XXXX
MM/YYYY
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
0181
THIS PRODUCT COMPLIES WITH ALLA PPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACTOF 1968.
Aluminium equivalence <= 0.9 mm AL
Max patient weight: 295 kg
Model: 0181
SN XXXX
MM/YYYY
Intermittent operation: 20% 1min ON / 4min OFF
0413
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0058
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETYACT OF 1968.
Model: 0058
SN XXXX
MM/YYYY
Al equivalency: 0.6 mm AL
0180
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATIONCONTROL
FOR HEALTH & SAFETYACT OF 1968.
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0413
Model: 0175
SN XXXX
MM/YYYY
Intermittent operation: 20% 1min ON / 4min OFF
Power rating:
230VAC, 50/60 Hz, 6A
100-230VAC, 50/60Hz, 1A
0413
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
0170CS
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATIONCONTROL
FOR HEALTH & SAFETYACT OF 1968.
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0413
Power rating: 2x115 VAC
Long-time (positioning) 2A, 50/60Hz
Momentary (exposure) 150A, 50/60 Hz
Associated equipment:
0181, 0175, 0170CS, 0058, 0180 SC
IEC60601-2-54:2009
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0058
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETYACT OF 1968.
Model: 0058
SN XXXX
MM/YYYY
Al equivalency: 0.25 mm AL
Associated equipment 0181, 0058
IEC60601-2-54:2009
0413
0413
13
14
3
12
3
11
10
7
6
3
1
2
3
4
5
8
9
Fig. 1-1
3484-01
ARCOMA AB
Annavägen 1, 352 46 Växjö, SWEDEN.
0413 0055
THIS PRODUCT COMPLIES WITH ALLAPPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATIONCONTROL
FOR HEALTH &SAFETYACT OF 1968.
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
Power rating: 100-240VAC 50/60Hz, 16A
Aluminium equivalence <= 0.9 mm
Max patient weight: 300 kg
Model: 0055
SN XXXX
MM/YYYY
Intermittent operation: 20% 1min ON / 4min OFF
15
16
3
Fig. 1-2
Introduction
Identification Labels