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P R E C I S I O N R A D I A T I O N T H E R A P Y

Elekta Compact™ R1.0x

Installation log book

Document number 1005572 01


Language: English
Copyright statement
©2008 Elekta AB (publ.). 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 is strictly reserved for Elekta and its
Licensees. Other use in any form and / or by any means whatsoever is prohibited.

Trademarks and trade names statement


Elekta® trademarks, service marks, logos and trade names used in this document are
registered and unregistered trademarks and trade names of Elekta AB (publ), one of
its affiliates, or third parties who have licensed their trademarks and trade names to
Elekta AB (publ) or one of its affiliates. Do not reproduce, display or otherwise use
any trademark or trade name without first obtaining written permission from Elekta.

Acknowledgement of other trademarks


Registered trademarks and trade names of other manufacturer, which appear in this
document are hereby acknowledged.

Referenced documents
Not all documents referred to in this document are part of the scope of delivery for
the equipment. Elekta reserves the right to determine which documents are delivered
with a product.

Contact information

TECHNICAL SUPPORT HELPDESK

TEL +86 10 8012 5400 – FAX +86 10 8012 5401 – e-mail: [email protected]

WORLDWIDE PRODUCT MANUFACTURING and SUPPORT CENTER

Elekta BMEI (Beijing) Medical Equipment Co. Ltd.


No. 21, ChuangXin Road
Science and Technology Park
Chang Ping District
Beijing 102200
China

European Authorized Representative

Elekta Limited
Linac House
Fleming Way, Crawley
West Sussex RH10 9RR
United Kingdom
Tel: +44 1293 544 422
Fax: +44 1293 654 118

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Table of content

Table of content
1 Installation log book
1.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2 Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 Location of log book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4 Installation log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.5 Field Change Orders (FCO). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.6 Linear accelerator installation information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.7 Installation Engineers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.8 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.9 Control the use of Electrostatic Discharge (ESD) sensitive devices. . . . . . . . . . . . . . . . . . . . . . . 1-6
1.10 Installation site delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

2 Installation checklists
2.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 Installation checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.3 Setting to work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4 Earth bonding (grounding) tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

3 Installation log

4 Service tables
4.1 Test equipment used (Elekta® PSC, BU or hospital) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2 Electrostatic Discharge (ESD) sensitive devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.3 Installation site delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

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1 Installation log book


Section Title Page

1.1 Overview .................................................................................................1-3

1.2 Scope ......................................................................................................1-3

1.3 Location of log book .................................................................................1-3

1.4 Installation log .........................................................................................1-4

1.5 Field Change Orders (FCO)..........................................................................1-4

1.6 Linear accelerator installation information .................................................1-4

1.7 Installation Engineers ...............................................................................1-5

1.8 Test equipment ........................................................................................1-5

1.9 Control the use of Electrostatic Discharge (ESD) sensitive devices ...................1-6

1.10 Installation site delays ..............................................................................1-6

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Installation log book
Overview

1.1 Overview
This document is for the sole use of Elekta installation engineers and representatives
of Elekta, installing an Elekta Compact™ linear accelerator. This document provides
a mechanism for installation engineers to document problems encountered during an
installation, and their proposed solution.
This document comprises.

Chapter 2 This chapter provides checklists for an installation of a linear


accelerator.
Chapter 3 Installation log. Use this chapter to record work completed during an
installation, and exceptions or deviations from the expected results.
Chapter 4 This chapter provides tables to record the test equipment used, record
the use of wrist straps when handling electrostatic discharge (ESD)
sensitive devices, and provides a log to reocrd site delays during an
installation.

Associated documentation
• Linear Accelerator, Installation manual.
• Linear Accelerator, Installation log book (this manual).

1.2 Scope
A comprehensive range of tests are completed in the factory to make sure the linear
accelerator is within specification, according to Elekta quality requirements.
These tests are supplemented further by a larger number of tests as described in the
Installation manual. These tests are completed at various stages of the installation to
make sure that parameters, which may be affected by the installation process, are
maintained and within specification.
Some tests in the setting to work (STW) section of the Installation manual are
replicated in the Customer Acceptance Test (CAT) manual. The tests in the CAT are
intended to provide the customer with familiarization and confidence in the
configuration of the system. These tests are completed upon the completion of the
installation process, and should not be confused with tests in the setting to work of
the equipment.

1.3 Location of log book


During the installation, the log book should be located with the linear accelerator
being installed. When the installation is complete, this document should be filed
according to Elekta QA procedures.

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Installation log book
Installation log

1.4 Installation log


All installation engineers should document problems encountered, and their solutions,
during an installation. A record of events affecting the installation should be recorded
in Chapter 3. Write the date, and the name of the installing engineer at the start of
each record.
Problems encountered or deviations from the specification or supplied configuration,
must be reported on a Customer Feedback Report (CFR), unless the problem is
considered an easy-to-resolve one-off problem, which does not have safety
implications and which is unlikely to be repeated. In these cases a CFR is not
required.
Make sure a record is made in the installation log, and, if necessary, record the
reference number of the CFR.

Note: Do not remove pages from the log book.

1.5 Field Change Orders (FCO)


The BU Service Manager should ensure that all mandatory FCOs, all desirable Action
for Performance, and Service recommendations have been implemented.

1.6 Linear accelerator installation information


Make a record of the equipment being installed and where it is being installed in
Table 1.1. This section can be completed by the BU Service Manager or the
installation engineer.

Table 1.1 Installation information

Machine Serial No:

Machine Type:

Table Serial No.

Table Type:

Hospital name:

City:

County:

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Installation log book
Installation Engineers

1.7 Installation Engineers


Table 1.2 is a list of all engineers working on the installation and setting to work of
the equipment. If more than one installation engineer is assigned to an installation,
make sure that their names are added.
Write your name, and the date when you start and finish on the installation. If
necessary, make sure that the names of additional engineers are recorded in
installation log (Chapter 3).

Table 1.2

Date commenced Date finished


Name of installation engineer
on project on project

1.8 Test equipment


All test equipment, and calibration dates of the test equipment, used during the
installation of a linear accelerator, supplied by either the regional office of Elekta,
Business Unit or by the hospital, must be recorded.
Test equipment should not be used if it is out of calibration. See Section 4.1.

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Control the use of Electrostatic Discharge (ESD) sensitive devices

1.9 Control the use of Electrostatic Discharge (ESD)


sensitive devices

Always wear a wrist strap when handling printed circuit boards (PCBs) and
other electronic sub-assemblies. The wrist strap and lead must be tested
prior to use. Failure to do so can lead to component failure.
CAUTION 1.1

Semiconductor devices and integrated circuits are susceptible to damage from


electrostatic discharges (ESD).
These components, and assemblies containing them, are described as electrostatic
discharge sensitive devices. If they are not handled correctly, these devices can be
destroyed immediately or suffer damage that will cause them to fail at a later date.
Whenever a printed circuit board (PCB) or other electronic subassembly is to be
handled, full electrostatic precautions should be taken.
Record when you use a wrist strap in Section 4.2. Resistances should be measured
prior to commencing tasks.

1.10 Installation site delays


Delays during the installation of a linear accelerator, should be recorded in
Section 4.3. Record the number of hours lost, the date the delay occurred. Include an
appropriate ‘delay category’, as listed in Table 1.3.

Note: The recording of installation site delays is only applicable in China. Recording
information on site delays in other regions is not necessary.

Table 1.3 Delay categories

Category Reason
This category covers time lost because the site was not in an
SR acceptable condition to commence installation, as specified in the
Linear Accelerator Site Planning Guide.
This category covers time lost due to problems that were outside the
SD control of Elekta, for example: a burst water pipe, or a power cut
not attributed to site preparation, etc.
This category covers time lost due to the fault of Elekta®, for
PQ example: design flaws, poor manufacturing, late delivery of service
parts, etc.

PF This category covers time that was lost that due to part failure.

TR This category covers time taken to travel to and from the site.

Record all delays, the date the delay occurred, a delay code, a brief description, the
time taken, and a Customer Feedback Report (CFR) number if applicable.

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Installation checklists

2 Installation checklists
Section Title Page

2.1 Overview .................................................................................................2-3

2.2 Installation checklist.................................................................................2-4

2.3 Setting to work.........................................................................................2-5

2.4 Earth bonding (grounding) tests .................................................................2-6

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Installation checklists
Overview

2.1 Overview
This chapter provides a checklist for the installing engineer to record that the required
procedures during an installation of a linear accelerator have been carried out
successfully.
Upon completion of a procedure, the installing engineer should indicate, against the
appropriate section, confirming that the check was carried out successfully, and
within specification. The installing engineer can either initial or stamp, and date, the
checklist.
Alternatively, depending upon local regulations, QA practices and procedures, it may
be acceptable to ‘tick’ the appropriate box to record that the check was completed,
and sign at the end of each checklist. It is not mandatory to initial all of these checks.
The installing engineer can be a representative of the customer, the local BU or Agent,
or an Elekta engineer (when applicable).

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Installation checklists
Installation checklist

2.2 Installation checklist


Upon completion of an installation procedure as detailed in the Installation manual,
the installing engineer should indicate, against the appropriate section, confirming
that the action was completed successfully and, if applicable, the result within
specification.
The installing engineer can either initial or stamp, and date, the checklist or,
depending upon local regulations, ‘tick’ in the appropriate box. If the Action is not
applicable to the configuration of the equipment, write N/A in the appropriate
column.

Table 2.1 Linear Accelerator installation checklist


Engineer to initial,
Action
stamp, or tick

Establishing the isocenter

Setting the external crosswires

Checking the uniform of X-radiation fields

Fitting the HT cables

Pressurizing the dielectric gas system

Fit discharging rod

Installation of covers set

Machine calibration - movements

Installation procedures:
Name: Date:

Installation Engineer:

Installation Engineer:

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Installation checklists
Setting to work

2.3 Setting to work


Use the instructions in the setting to work (STW) section in the Linear Accelerator
Installation Manual. Make a note in Section 3 where there are significant deviation in
settings from the factory values.
Upon completion of the STW, the installing engineer should indicate below
confirming that all procedures were carried out, and if applicable, within
specification.

Setting to work procedures:


Name: Date:

Installation Engineer:

Installation Engineer:

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Installation checklists
Earth bonding (grounding) tests

2.4 Earth bonding (grounding) tests


The areas on the linear accelerator where tests will need to be completed, will depend
upon the configuration of the equipment being installed, and determined by the
installing engineer and dependent on local QA procedures and regulations.
The test locations in Table 2.2 outline the minimum number of tests that should be
completed.

Table 2.2 Earth bonding test locations

Test Measured
Resistance
Test location current voltage Remarks
(Ω)
(Amp) (V)
Beam limiting device (BLD)
PSS column
PSS floor pan
HHC bracket left
Monitor bracket left
HHC right
Monitor right
Gantry
Stand
Base frame
Gun filament PSU
Vacuum pump PSU
Magnetron filament PSU
Pulse transformer
Treatment room cabinet
(TRC)
Main control cabinet
(MCC)
EIM
Modulator
Discharge stick
Fascia posts
Front-end computer (FEC)

Note: There is no requirement to test the touchguard ring and the table top, as these items
are isolated and not intended to be earthed.

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Installation checklists
Earth bonding (grounding) tests

Action Engineer to initial, stamp, or tick, and date

Earth bonding checks

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Installation log

3 Installation log
Record problems encountered which may affect the installation, and if necessary,
make a note of the solution. Record significant deviation in settings, from the factory
settings.
Write the date and the name of the installating engineer, at the start of each record.
Make sure that this is clearly written at the top of each record. If more than one
installation engineer works on the equipment, make sure their names are added to the
log.
Record exceptions to the expected results of tests undertaken, corrective actions taken
or needed (repairs, Customer Feedback Report CFRs), and items that need to be
followed up if more than one engineer is assigned to the installation, or an engineer is
replaced.

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Service tables

4 Service tables
Section Title Page

4.1 Test equipment used (Elekta® PSC, BU or hospital) .......................................4-3

4.2 Electrostatic Discharge (ESD) sensitive devices .............................................4-4

4.3 Installation site delays ..............................................................................4-5

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Service tables
®
Test equipment used (Elekta PSC, BU or hospital)

4.1 Test equipment used (Elekta® PSC, BU or hospital)


All test equipment used during the installation of a linear accelerator, supplied by
either the regional office of Elekta, product supply center (PSC), Business Unit or by
the hospital, must be recorded.

Note: Test equipment must not be used if it is out of calibration.

Table 4.1 Product Support Center (Crawley) / Business Unit test equipment

Make / Model / Description Elekta Serial number Calibration date

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Service tables
Electrostatic Discharge (ESD) sensitive devices

4.2 Electrostatic Discharge (ESD) sensitive devices


Always wear a wrist strap when handling printed circuit boards (PCBs) and other
electronic sub-assemblies. Make sure wrist straps and leads are checked on a routine
basis. Record the resistance before and after use.

Table 4.2 Electrostatic handling

Date Test result Signed

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

Work surface

Wrist strap

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Service tables
Installation site delays

4.3 Installation site delays


Record the number of hours lost, the date the delay occurred, and a ‘delay category’
code. See Section 1.10 for a list of delay codes.

Table 4.3 Installation site delays

Delay code
Date Time taken CFR number
(see Brief description
occurred (Man hours_ (if applicable)
Section 1.10)

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Service tables
Installation site delays

Table 4.3 Installation site delays

Delay code
Date Time taken CFR number
(see Brief description
occurred (Man hours_ (if applicable)
Section 1.10)

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Fighting serious disease www.elekta.com
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Regional Head Offices for Sales, Marketing & Services

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