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Precise Table
User’s Manual 4513 370 1860 06
TECHNICAL SUPPORT HELPDESK - ALL PRODUCTS
TEL +44 (0)1293 654 400 FAX +44 (0)1293 654 401 E-mail: [email protected]
WORLDWIDE PRODUCT MANUFACTURING and SUPPORT CENTERS
ONCOLOGY
NEUROSURGERY
ELEKTA LIMITED LINAC HOUSE FLEMING WAY, CRAWLEY WEST SUSSEX RH10 9RR UK TEL +44 (0)1293 544 422 FAX +44 (0)1293 654 118
ELEKTA INSTRUMENT AB KUNGSTENGATAN 18 BOX 7593 SE-113 57 STOCKHOLM SWEDEN TEL +46 858 725 400 FAX +46 858 725 500
REGIONAL OFFICES
NORTH AMERICA
ASIA-PACIFIC
JAPAN
EUROPE, AFRICA, MIDDLE-EAST & SOUTH AMERICA
ELEKTA INC. 4775 PEACHTREE INDUSTRIAL BLVD BUILDING 300, SUITE 300 NORCROSS GEORGIA 30092 USA TEL +1 770 300 9725 FAX +1 770 448 6338
ELEKTA INSTRUMENTS ASIA LTD 28th FLOOR, MORRISON PLAZA 9 MORRISON HILL ROAD WANCHAI HONG KONG TEL +852 2891 2208 FAX +852 2575 7133
ELEKTA KK KOBE MK BUILDING 2F 6-1-9 ISOGAMI-DORI 6-CHOME CHUO-KU KOBE 651-0086 JAPAN TEL +81 78 241 7100 FAX +81 78271 7823
ELEKTA LIMITED LINAC HOUSE FLEMING WAY, CRAWLEY WEST SUSSEX RH10 9RR UK TEL +44 (0)1293 544 422 FAX +44 (0)1293 654 118
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©2004 Elekta Limited. All rights reserved.
Copyright Statement ©2004 Elekta Limited. All rights reserved. No part of this document may be reproduced in any form without written permission from the copyright holder. Use of the information contained herein in any form and / or by any means whatsoever is strictly reserved for Elekta® and its Licensees. Use of this equipment by unauthorized persons is strictly prohibited.
Trademarks Elekta®, Leksell Gamma Knife®, Gamma Knife®, Leksell Stereotactic System®, Stereotactic Guide™, Leksell SurgiPlan®, Leksell®, GammaPlan®, Leksell® Coordinate Frame, Leksell® Neuro Generator, Render-Plan 3-D®, Stereotactic Body Frame®, AtlasSpace™, Precise Treatment System™, PreciseSIM®, iView™, iViewGT™, PrecisePLAN®, PreciseBEAM®, Active Breathing Coordinator™, Automatic Positioning System™, Henning Instrument Guide™, Leksell GammaPlan® Wizard™, Leksell GammaPlan® Target Series™, OmniWedge™, PreciseNET™, Remote Service™, VectorView™, Elekta Paradigm™, Elekta Synergy™, Gamma FastSite™, and Neuromag® are registered trademarks of Elekta AB (publ) or its subsidiaries or are subject to filed trademark applications. All rights reserved. Communication to the DICOM standard is licensed from Merge Technologies Inc., Milwaukee USA DICOM by Merge
Acknowledgement of Other Trademarks Other manufacturers registered trademarks and trade names which appear in this document are hereby acknowledged.
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Amendments Each page of this document contains a date in the footer (e.g. 01.01) indicating its issue status. Whenever a page is amended by Elekta®, this issue status will be updated. All amendments are issued in the form of a Field Change Order Documentation (FCO) which permit Elekta® to formally distribute specific amendment instructions. Each amendment notice is identified by a unique reference number. It is the user’s responsibility to ensure that amendments are incorporated into this copy and the reference number, date and signature entered into the Amendment Record below.
Amendment Record When an amendment is incorporated in this publication, enter its number and the date of incorporation, then sign your name alongside. Amendment No.
Date
Signature
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Table of Contents
Table of Contents 1 Introduction 1.1 About This Manual... 1-3 1.1.1 Warnings, Cautions and Notes... 1-3 1.1.2 Intended Audience... 1-4 1.1.3 Disclaimer... 1-4 1.2 Intended Use... 1-4 1.3 Compatibility... 1-4 1.4 Compliance... 1-5 1.4.1 IEC Safety Standards... 1-5 1.4.2 IEC Classification... 1-5 1.5 Training... 1-6 1.6 Accompanying Documentation... 1-7 1.7 Safety... 1-7 1.7.1 Important Safety Directions... 1-7 1.7.2 Warning Labels... 1-8 1.7.3 Maintenance and Faults... 1-9 1.7.4 Safety Devices... 1-10 1.7.5 Emergency Procedures... 1-10 1.7.6 Electrical and Mechanical Safety... 1-10 1.7.7 Electrostatic Discharge Sensitive Devices... 1-11 1.7.8 Fire and Explosion Safety... 1-11 1.7.9 Electromagnetic Compatibility (EMC)... 1-11 1.7.10 Cardiac Pacemakers and Other Portable Electronic Medical Devices . 1-12 1.7.11 Radiation... 1-12 1.7.12 Induced Radioactivity... 1-12 1.7.13 Laser Product... 1-13 1.8 Final Disposal... 1-13 1.9 Text Formats... 1-14 1.10 Terms... 1-15 1.11 Abbreviations... 1-17 1.12 Important Notices... 1-23 1.13 User Notices... 1-25
2 Using the Precise Table 2.1 Introduction... 2-2 2.1.1 System Description... 2-2 2.2 Parts Description... 2-3 2.3 User Interfaces... 2-4 Precise Table
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Table of Contents
2.3.1
User Interface Description... 2-4
2.4 Patient Positioning... 2-5 2.5 Precise Table Movements... 2-5 2.5.1 Enabling Movements Procedure... 2-5 2.5.2 Foot of the Precise Table... 2-6 2.5.3 Direction Symbols - Movement... 2-6 2.5.3.1 User Interface Priority of Movement... 2-7 2.5.3.2 Handheld Controller Priority of Movement... 2-7 2.5.4 Assisted Set Up (ASU)... 2-7 2.5.4.1 Remote-controlled table movement using ASU... 2-8 2.6 Brakes... 2-8 2.6.1 Direction Symbols - Brakes... 2-9 2.6.2 Touch Guard Override... 2-10 2.7 Emergency Stop Motors... 2-11 2.7.1 Disable Movements Procedure... 2-11 2.7.2 Reset Motors... 2-12 2.8 Emergency Down Drive Procedure... 2-13 2.9 Precise Table Movement Limits... 2-14 2.10 Table Data... 2-15 2.10.1 Table Vertical... 2-15 2.10.2 Table Lateral... 2-16 2.10.3 Table Longitudinal... 2-17 2.10.4 Column Rotation... 2-18 2.10.5 Isocentric Rotation... 2-20
3 Table Tops 3.1 Introduction... 3-2 3.1.1 Types... 3-2 3.1.2 Usage... 3-2 3.1.3 Permissible Loads... 3-2 3.1.4 Inspection/Maintenance... 3-2 3.1.5 Removing the Table Top... 3-3 3.1.6 Rotating the Table Top... 3-3 3.1.7 Accessories... 3-4 3.1.7.1 Fitting an Accessory... 3-4 3.2 Standard Therapy Table Top... 3-5 3.2.1 Design... 3-5 3.2.2 Loading Conditions for Accessories... 3-5 3.2.3 Standard Therapy Table Top Panels... 3-6 3.2.3.1 Removing Panels... 3-6 3.2.3.2 Replacing Panels... 3-6 3.2.3.3 Special Care Instructions... 3-6 3.3 C-Arm Therapy Table Top... 3-7 3.3.1 Design... 3-7 4513 370 1860 06
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3.3.2 Loading Conditions for Accessories... 3-8 3.3.2.1 Removable Accessory Rails... 3-8 3.3.2.2 Fixed Accessory Rails... 3-8 3.3.3 C-Arm Opening Dimensions... 3-9 3.4 C-Arm Functionality... 3-10 3.4.0.1 Changing the C-Arm Position... 3-10 3.4.1 Tennis Racquet Panels... 3-11 3.4.1.1 Removing the Tennis Racquet Panel... 3-11 3.4.2 Headboard/Footboard... 3-11 3.4.2.1 Fitting the Headboard/Footboard... 3-11 3.4.2.2 Removing the End Panel... 3-12 3.4.2.3 Fitting the End Panel... 3-14 3.4.2.4 Fitting/Removing Accessory Rails... 3-15 3.4.2.5 Warning and Labels on the Table Top... 3-16 3.5 Simulator Table Top (Carbon Fiber)... 3-17 3.5.1 Design... 3-17 3.5.2 Warnings and labels... 3-17
4 Maintenance 4.1 Environmental Conditions... 4-2 4.2 Maintenance... 4-3 4.2.1 Planned Maintenance... 4-3 4.2.1.1 Planned Maintenance Programme... 4-3 4.2.2 User Routine Checks... 4-4 4.3 Cleaning and Disinfecting... 4-5 4.3.1 Cleaning - General... 4-6 4.3.2 Cleaning and Disinfection - Patient Contact Surfaces... 4-6
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List of Figures & Tables
List of Figures & Tables Table 1.1 Table 1.2 Figure 2.1 Table 2.1 Figure 2.2 Table 2.2 Table 2.3 Table 2.4 Table 2.5 Table 2.6 Figure 2.3 Figure 2.4 Figure 2.5 Figure 2.6 Figure 2.7 Figure 2.8 Figure 2.9 Figure 2.10 Figure 2.11 Figure 2.12 Figure 2.13 Figure 2.14 Figure 3.1 Figure 3.2 Figure 3.3 Figure 3.4 Figure 3.5 Figure 3.6 Figure 3.7 Figure 3.8 Figure 3.9 Figure 3.10 Figure 3.11 Figure 3.12 Figure 3.13 Figure 3.14 Figure 3.15 Figure 3.16 Figure 3.17 Figure 3.18 Figure 3.19 Figure 3.20 Figure 3.21 Figure 3.22 Table 4.1 Table 4.2
Manual Set 4513 370 3951... 1-7 Manual Set 4513 341 3003... 1-7 Precise Table - main assemblies... 2-2 Precise Table parts description... 2-3 Precise Table user interface... 2-4 Enabling Precise Table movements... 2-5 Direction Symbols - movement... 2-6 Brakes... 2-8 Direction symbols - brakes... 2-9 Precise Table movement limits... 2-14 Table vertical-IEC 1217, Bipolar, IEC 601... 2-15 Table lateral-IEC 1217 and Bipolar... 2-16 Table lateral-IEC 601... 2-16 Table longitudinal-IEC 1217... 2-17 Table longitudinal-Bipolar... 2-17 Table longitudinal-IEC 601... 2-17 Column rotation-IEC 1217... 2-18 Column rotation-Bipolar... 2-19 Column rotation-IEC 601... 2-19 Isocentric rotation-IEC 1217... 2-20 Isocentric rotation-Bipolar... 2-20 Isocentric rotation-IEC 601... 2-20 Table top latch - open position... 3-3 Rotating the table top... 3-3 Table aligned and table lock in closed position... 3-4 Standard Therapy Table Top - design... 3-5 C-Arm Therapy Table Top - design... 3-7 C-Arm maximum rectangular opening dimensions (mm)... 3-9 C-Arm oblique opening dimensions (mm)... 3-9 C-Arm functionality... 3-10 C-Arm section positioned at foot of table... 3-12 Extension panel release latch - top and underside view... 3-12 Removing extension panel... 3-12 Telescopic frame latch... 3-13 Support bars... 3-13 Telescopic frame latch... 3-14 Removing support bars... 3-14 Re-latching panel... 3-14 Accessory rail fixing screw... 3-15 Warning Symbol... 3-16 Simulator table top - design... 3-17 Permissable Load on Accessory Rails... 3-18 Offset Loading of Accessory Rails... 3-18 Safe Loading... 3-19 Environmental conditions for operation... 4-2 Precise Table planned maintenance program... 4-3
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List of Figures & Tables
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Introduction
1
Introduction Section
Title
Page
1.1
About This Manual ... 1-3
1.2
Intended Use... 1-4
1.3
Compatibility ... 1-4
1.4
Compliance ... 1-5
1.5
Training ... 1-6
1.6
Accompanying Documentation... 1-7
1.7
Safety ... 1-7
1.8
Final Disposal ... 1-13
1.9
Text Formats ... 1-13
1.10
Terms ... 1-15
1.11
Abbreviations ... 1-17
1.12
Important Notices... 1-23
1.13
User Notices ... 1-25
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Introduction About This Manual
1.1
About This Manual This manual is intended to assist users in the safe and effective operation of the equipment described. The user includes the body with authority over the equipment and those persons who actually handle the equipment. Before attempting to work with this equipment the user must read, understand, note and strictly observe all: • warnings • cautions • release notes (delivered with the software media pack) Pay special attention to all the information given, and procedures described, in Section 1.7 Safety. The documentation must be kept with the system for easy reference. The most extensive configuration is described within this manual, including the maximum number of options and accessories. Not every function, option or accessory described may have been purchased or licensed on a particular piece of equipment.
Examples To aid the understanding of the contents in this manual, examples of patient, physician and hospital names may be used. These names are fictitious and any resemblance to person(s) and/or organization(s) is entirely coincidental.
1.1.1
Warnings, Cautions and Notes The following are samples of how warnings, cautions and notes will appear throughout this document. The text within the samples explains their intended use.
Warnings are directions which, if not followed, could constitute a health hazard or cause injury, including fatal or serious injury, or could lead to clinical mistreatment. WARNING x
Cautions are directions which, if not followed, could cause damage to the equipment described in this manual, and/or any other equipment or goods, and/or could cause environmental damage. CAUTION x
Note:
Notes provide advice and highlight unusual points. A note is not intended as an instruction.
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Introduction Intended Use
1.1.2
Intended Audience This manual is written for trained users of Precise Table and for Elekta® field service personnel.
1.1.3
Disclaimer Elekta® assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document. However, Elekta® assumes no responsibility or liability for errors, inaccuracies, or omissions that may appear in this document. Elekta® reserves the right to change the product without further notice to improve reliability, function or design. This manual is provided without warranty of any kind, either implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
1.2
Intended Use The Precise Table supplied by Elekta is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta® digital accelerators and simulators and adaptable to third party radiotherapy products. It should be installed, used and operated only in accordance with the safety procedures given within this manual. Nothing stated in this manual reduces the user’s professional responsibilities for sound judgement and best practice. Installation, use and operation of this equipment is subject to the law in the jurisdictions in which the equipment is being used. Users shall only install, use and operate the equipment in such ways that do not conflict with applicable laws or regulations which have the force of law. Use of the equipment for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use or operation, may relieve the manufacturer or his agent from all or some of the responsibility for resultant non-compliance, damage or injury..
In the United States, Federal law restricts this device to sale, distribution, and use by or on order of a licensed physician. CAUTION 1
1.3
Compatibility Equipment described in this manual shall only be used in combination with other equipment or components if these are expressly recognized by Elekta® as compatible. A list of such equipment and components is available from Elekta® on request.
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Introduction Compliance
The use of accessories, transducers, and cables other than those specified by Elekta® may result in increased emissions or decreased immunity of the equipment. Changes and/or additions to the equipment shall only be carried out by persons expressly authorized to do so by Elekta®. Such changes shall comply with best engineering practice and all applicable laws and regulations that have the force of law within the jurisdiction.
WARNING 1
1.4
Changes, additions or maintenance to the equipment carried out by persons without appropriate qualifications and training and/or using unapproved spare parts may lead to fatal or serious personal injury and/or damage to the equipment as well as making the warranty void.
Compliance Note:
The Precise Table has been designed and tested for compliance when used in the Clinical mode only. Precise Table is designed to comply with internationally recognized standards for safety and performance.
1.4.1
IEC Safety Standards Precise Table complies with the following IEC Safety Standards: • IEC 60601-1 Medical electrical equipment, Part 1: General requirements for safety. • IEC 60601-2-1 (including Amendment 1) Safety of Medical Electrical Equipment: Particular requirements for medical electron accelerators in the range 1 MeV to 50 MeV. Section One: General Section. Section 2: Radiation Safety for Equipment.
1.4.2
IEC Classification According to IEC 60601-2-1 Precise Table is classified as set out in the table below: Type of protection against electric shock
CLASS 1 EQUIPMENT TYPE B APPLIED PARTS
Degree of protection against electric shock
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Introduction Training
1.5
Degree of protection against ingress of liquids
IPX0 as defined in IEC 60529. Ordinary equipment (enclosed equipment without protection against ingress of liquids)
Methods of disinfection recommended by the manufacturer
Disinfectable equipment (or elements). See ‘Accompanying Documentation’ for methods
Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide
Equipment NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen, or nitrous oxide
Mode of operation
Suitable for continuous operation
Training Users of the Precise Table shall have received adequate training on its safe and effective use before attempting to work with it. Training requirements may vary from country to country. The user shall make sure that training is received in accordance with local laws or regulations that have the force of law. Information on training is available from the local Elekta® representative.
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Introduction Accompanying Documentation
1.6
Accompanying Documentation This manual forms part of the accompanying documentation set for this product. The complete sets of documents are listed in Table 1.1(Elekta Precise Treatment System™, Elekta SLS Simulator and Elekta Synergy™ Platform) and in Table 1.2 (when used with Elekta PreciseSIM™) Table 1.1
Manual Set 4513 370 3951
Manual Set: 4513 370 3951 Publication Title
Publication No.
Precise Table User’s Manual
4513 370 1860
Precise Table Installation Manual
4513 370 1861
Precise Table Corrective Maintenance Manual
4513 370 1862
Precise Table Customer Acceptance Tests
4513 370 1863
Precise Table Preventative Maintenance Manual
4513 370 1864
Table 1.2
Manual Set 4513 341 3003
Manual Set: 4513 341 3003 Publication Title
Publication No.
Precise Table Installation Manual
4513 370 1861
Precise Table Corrective Maintenance Manual
4513 370 1862
PreciseSIM
TM
4513 370 1910
PreciseSIMTM Installation Manual
4513 370 1918
PreciseSIMTM Service Manual
4513 370 1919
TM
4513 370 1920
PreciseSIM
1.7
Users Manual
QA Manual
PreciseSIMTM Customer Acceptance Tests
4513 370 1921
Installation Log Book
4513 370 3640
Safety Every reasonable precaution has been taken during manufacture to safeguard the health and safety of persons who will operate this system. The precautions in the following sections must be observed at all times.
1.7.1
Important Safety Directions Elekta® products are designed to meet stringent safety standards. All medical electrical equipment requires proper installation, operation, and maintenance (particularly with regard to safety).
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Introduction Safety
To help ensure the safety of users and patients, it is vital that the user read, understand, note, and where applicable, strictly observe all warnings, cautions and safety markings within this document and on the machine. In particular, the user must read, understand and know the Emergency Procedures described in Section 1.7.5 before attempting to work with the equipment. The user should note the following information in this chapter: • Intended use • Training
1.7.2
Warning Labels The following are examples of some of the warning labels that may be found on Elekta® products:
Warning label
Indicates a specific warning if displayed in conjunction with warning text. Instructs user to refer to system documentation if displayed without warning text.
Radiation warning label
Indicates the possibility of a radiation hazard.
High voltage warning label
Indicates the presence of high voltage.
Laser warning label
Indicates the presence of a laser device.
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