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IQM

Integral Quality Monitor

User Reference Manual

iRT Systems
Schlossstrasse 1, 56068 Koblenz, Germany
www.i-rt.de
Copyright & Disclaimer

IQM User Manual


© 2015-2021 iRT Systems GmbH. All rights reserved.

iRT Systems GmbH


Schlossstrasse 1, 56068 Koblenz, Germany
info@i-rt.de · http://www.i-rt.de

This device bears the CE mark in conformance with the European Medical
Device Directive

Copyright & Disclaimer for the Contents of this Manual


This manual and the software described herein are made available in confidence as
part of a license agreement and for the sole use of assisting the user in correct use of the
hardware and software of the system. This manual contains proprietary information and
may not be shared or distributed to other persons or 3 rd parties without explicit written
consent of iRT Systems.
The contents of this manual are protected under copyright law. No part of the manual
may be stored in a database or distributed in electronic, mechanical, recorded form or
in any other way, without the prior written agreement of iRT Systems GmbH.
The authors have made great effort to ensure that the information provided in this
manual is correct. To the extent possible under applicable law, iRT disclaims any liability
for material or immaterial damages, direct, indirect, incidental or consequential
damages (including business damages) arising from the use or inability to use this manual
or the information provided within, including liability due to omissions and/or errors. If the
reader is unsure of the meaning or appropriateness of any information provided in this
manual, then the reader should contact iRT Systems for more information before
proceeding to use this manual.
iRT has endeavored to respect the copyrights of the graphics and texts included in all
publications, to use his/her own graphics and texts and to rely on license-free graphics
and text. All brands and trademarks – also those held or possibly protected by third
parties - mentioned in this manual are subject to the applicable trademark laws and the
rights of the copyright owner(s) without restriction. All trademarks are the property of their
respective owners and acknowledged. Naming alone shall not imply that trademarks
are not protected by the rights of a third party. The copyright for published objects

IQM User Reference Manual (v1.35a SW-v1.8) i


created by the author remains solely with the author of this manual. The reproduction or
use of such graphics or texts in other media is prohibited unless the prior written consent
of the author has been obtained.
The test data and cases that might be delivered with the product have been created
for demonstration cases and are not based on patient files or data of real persons, living
or not living. Any references to patient names or IDs are fictional and created for this
purpose.
This disclaimer is to be regarded an integral part of this manual. Should any sections or
individual terms of this text fail to be legal, enforceable or correct, the residual part of
this document shall remain unaffected and in effect.

Trademarks and logos:


The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth
Special Interest Group (Bluetooth SIG) Inc. and any use of such marks by iRT Systems is
under license.
Other trademarks and trade names are those of their respective owners.

IQM User Reference Manual (v1.35a SW-v1.8) ii


Applicability
This manual applies to IQM software release versions v1.8 & up, used with all IQM
data acquisition hardware configurations.

Revision History
Revision Released Changes made (chapter/page)
on
1.35a 2021-07- Update to reflect IQM software update 1.8.18
09 6.4.3 [SystemLimits] Section (IQM Workstation only):
updated MinRefSignal minimum and default values to 0.1

1.35 2021-02- Updates to reflect IQM software update 1.8


23

1.34.1 2019-07- Update to reflect IQM software update 1.7.8.2.


19
1.34 2019-05- Update to reflect IQM software version 1.7.
27
1.33 2018-07- Update to reflect IQM software version 1.6.
11
1.32 2017-12- Update to reflect IQM software version 1.5.
18
1.31 2017-07- Update to reflect IQM software version 1.4.
31
1.30 2016-11- Update to reflect IQM software version 1.2.
18

IQM User Reference Manual (v1.35a SW-v1.8) iii


Declarations of Conformity

IQM User Reference Manual (v1.35a SW-v1.8) iv


Declarations of Conformity

IQM User Reference Manual (v1.35a SW-v1.8) v


Declarations of Conformity
Declarations of Conformity are made to satisfy regulatory requirements in the
markets to which IQM is distributed.

Please contact iRT to request a DoC for a specific regulation or market if desired.

IQM User Reference Manual (v1.35a SW-v1.8) vi


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IQM User Reference Manual (v1.35a SW-v1.8) vii


Table of Contents
Copyright & Disclaimer ............................................................................................... i

Applicability .............................................................................................................. iii

Revision History .......................................................................................................... iii

Declarations of Conformity ...................................................................................... iv

Table of Contents .................................................................................................... viii

1 About this Manual ........................................................................................... 1-1


1.1 Warning Messages ................................................................................... 1-1
1.2 Caution Messages .................................................................................... 1-1
1.3 Safety Signs & Symbols .............................................................................1-2
1.4 Location and Availability of the Manual and Electronic Instructions for
Use (eIFU)..............................................................................................................1-4

2 About the IQM System .................................................................................... 2-1


2.1 Medical Purpose & Main Features (Intended Use) ................................ 2-1
2.2 Theory of Operations/System Overview ................................................. 2-2
2.3 Limitations and Exclusions, Contraindications ........................................2-9
2.4 Safety Notices ......................................................................................... 2-12
2.5 Use Environment ..................................................................................... 2-17
2.6 Accuracy & Precision of the Measurement System ............................ 2-21
2.7 Not Intended to Replace Absolute Dosimetry Systems ....................... 2-22

3 Implementing IQM .......................................................................................... 3-1


3.1 Installation & Training................................................................................ 3-1
3.2 Responsibility of the User and the User Institution...................................3-2
3.3 Information for Persons Responsible for Network and IT Installation .....3-4
3.4 Overview of IQM Components ............................................................... 3-6
3.5 Integration in the Radiation Therapy Department Network ............... 3-12
3.6 Fixation Hardware - Attaching the IQM Mount to the IQM Detector 3-18
3.7 Attaching and Detaching IQM at the Linac ........................................ 3-19

IQM User Reference Manual (v1.35a SW-v1.8) viii


3.8 Setting up Patient Treatments Safely when IQM is Installed ................ 3-21
3.9 Installation of the IQM Transceiver in Treatment Room ....................... 3-22
3.10 Serial Cable & Electrical Isolation of Connections ............................... 3-25
3.11 IQM Transceiver and IQM Detector Connection ................................. 3-26
3.12 Verifying Communication between Workstation & Detector ............. 3-26
3.13 Power Supplies ........................................................................................ 3-28

4 Monitoring Treatments with IQM .................................................................... 4-1


4.1 How IQM Verifies Field Delivery ............................................................... 4-1
4.2 Daily System Startup ................................................................................. 4-6
4.3 Detector Ready and Other Detector Indicators ...................................4-8
4.4 Starting the IQM Workstation & Authorized Permissions ...................... 4-12
4.5 Importing Dicom RT Plans to the IQM Database ................................. 4-12
4.6 Starting the IQM Monitor Application & Test of “Alarm” Function...... 4-16
4.7 Confirming that IQM is Ready – Status Indicators in Software ............ 4-19
4.8 Monitoring Treatments with the IQM System ........................................ 4-22
4.9 When Field Delivery or IQM Monitoring Ends ....................................... 4-37
4.10 Clinical Alarms during Treatment Delivery ............................................ 4-41
4.11 Field Errors During Field Delivery............................................................. 4-49
4.12 At the End of Monitoring ........................................................................ 4-60
4.13 Charging the IQM Detector .................................................................. 4-61
4.14 Special Considerations for Varian ADI users ......................................... 4-64
4.15 Automated Field Sequence Handling (AFS) ........................................ 4-68

5 Using IQM Review ........................................................................................... 5-1


5.1 Main Functions, Access Permissions and Responsibility ......................... 5-1
5.2 Selecting a Patient for Review.................................................................5-2
5.3 Review Application Display .....................................................................5-3
5.4 Setting the Baseline for Future Deliveries of a Field .............................. 5-12
5.5 Creating Reports in Microsoft Excel from Review Data ....................... 5-16
5.6 Creation of Reports by IQM Reporter ................................................... 5-18

IQM User Reference Manual (v1.35a SW-v1.8) ix


6 Managing the IQM System ............................................................................. 6-1
6.1 Clinical Rules (Criteria settings for Clinical Alerts & Alarms) .................. 6-1
6.2 Segment Merging and Smoothing Rules (in Configuration Settings) . 6-22
6.3 Treatment Planning Considerations for IQM ........................................ 6-32
6.4 Software Configuration File IQM.Config.ini .......................................... 6-38
6.5 IQM Database ........................................................................................ 6-60
6.6 Periodic QA of the IQM System ............................................................. 6-61
6.7 Calculation Application and Algorithm ............................................... 6-64
6.8 Dose Output Correction (DOC) Factor ................................................ 6-71

7 EMC Declarations per IEC 60601-1-2 (Edition 4.0) ........................................ 7-1


7.1 Electromagnetic Emissions .......................................................................7-2
7.2 Electromagnetic Emissions - per IEC 60601-1-2, 4th edition .................... 7-3
7.3 Electromagnetic Immunity – per IEC 60601-1-2, 4th edition ................... 7-4
7.4 Recommended Distances between Communications Equipment and
IQM System Components – IEC 60601-1-2, 4th edition ......................................7-9
7.5 Bluetooth® Implementation & Declarations ........................................ 7-10

8 Maintenance & Service of the IQM ............................................................... 8-1


8.1 Getting Support (Service) for the IQM System .......................................8-1
8.2 Contact information for iRT Support........................................................ 8-1
8.3 Identifying Detector Serial Number & Software Version Number .........8-4
8.4 Installing IQM Software Updates ............................................................. 8-6
8.5 Data Backup ............................................................................................. 8-6
8.6 Servicing IQM Measurement Hardware ............................................... 8-10
8.7 Use of the IQM Detector Service Attenuator / Dummy....................... 8-12
8.8 Replacing the Detector Battery Pack................................................... 8-13
8.9 Proper Handling of Batteries When Device is Not in Use ..................... 8-14
8.10 Safe Removal & Recycling of Batteries ................................................ 8-14
8.11 Handling Damaged Batteries ................................................................ 8-15
8.12 Housekeeping & Cleaning Recommendations ................................... 8-16
8.13 Storage Environment .............................................................................. 8-17
8.14 End of Service Life & Disposal ................................................................ 8-18

IQM User Reference Manual (v1.35a SW-v1.8) x


8.15 RoHS Statement ...................................................................................... 8-19

9 IQM Labelling .................................................................................................. 9-1


9.1 IQM Detector ............................................................................................ 9-1
9.2 IQM Transceiver ........................................................................................ 9-6
9.3 IQM Mounts ............................................................................................... 9-8
9.4 IQM Detector Service Dummy.................................................................9-9
9.5 IQM Workstation ....................................................................................... 9-9
9.6 Internal Detector Labels ......................................................................... 9-10
9.7 IQM Server ............................................................................................... 9-10

10 Glossary ......................................................................................................... 10-1

11 List of Tables ................................................................................................... 11-1

Appendix 1 - System QA & Validation .............................................................. 1


1.1 QA Field Test........................................................................................... A1-1
1.2 General Example Applicable for Most Collimators ............................ A1-2
1.3 Example for Varian HD MLC120 Collimator ......................................... A1-3

Appendix 2 - EMC Declarations per IEC 60601-1-2, 3.0 .................................. 1

Appendix 3 – Recommendations for Training .................................................. 1

Appendix 4 – Recommendations for Safety Check per IEC 62365 ................. 1

Appendix 5 - Dose Output Correction Factor & DOC Factor Editor ................ 1
1.1 Dose Output Correction (DOC) in IQM ............................................... A5-1
1.2 Specifying the DOC Factor ................................................................... A5-2
When to update the DOC Factor .............................................................. 3
1.3 Using the DOC Factor Editor ................................................................. A5-3
Calculating the DOC Factor from Reference and Measured IQM Signals . 5
Entering the DOC Factor Manually ...................................................... A5-6
Saving the New DOC Factor ................................................................ A5-7
Reviewing Past DOC Factors ................................................................ A5-9
DOC factor update after upload of a new machine configuration file 9
1.4 DOC Factor Handling in Monitor ........................................................ A5-10

IQM User Reference Manual (v1.35a SW-v1.8) xi


1.5 How IQM Applies the DOC Factor in Monitor ................................... A5-10
1.6 DOC Factor Presentation in Reports .................................................. A5-12
1.7 DOC Factor Display in Review ............................................................ A5-14

IQM User Reference Manual (v1.35a SW-v1.8) xii


IQM User Reference Manual (v1.35a SW-v1.8) xiii
1 About this Manual
This manual follows style conventions to identify key safety, performance and
configuration information. It is intended for radiation therapy professionals
working in a professional clinical or hospital environment. Users are assumed to
be therapists, dosimetrists, oncologists and medical physicists familiar with the
correct and safe use of the linear accelerator and ancillary equipment and with
the laws and regulations of their location, in particular as these pertain to safety.

Compliance with laws and regulations and with the instructions provided in this
manual is mandatory for the safety of users and patients.

See section 1.4 for information about the location and availability of electronic
(PDF) copies of this manual ("electronic Instructions for Use" or "eIFU").

1.1 Warning Messages


Warning messages indicate situations that could cause loss of life, major or minor
harm to the patient or the system user (or other persons, if applicable).

Warning messages are shown in a black box, with a warning symbol (a black
exclamation point in a yellow triangle) at the left side. The text begins with the
title “Warning:” For the IQM System, which does not directly affect the patient
nor directly control any other system that directly affects the patient, these
messages relate primarily to electric hazards, mechanical hazards (such as the
detector physically falling or colliding with the patient) and the potential for
misuse or misunderstanding by the user.

Example:

Warning:
Never spray water or cleaner directly at the equipment. Do not
allow water or cleaner to be splashed or spilled on the
equipment. Electrical hazard!
Instruct all cleaning and department staff accordingly.

1.2 Caution Messages


Caution messages have a high impact on system function but cannot cause loss
of life or significant harm to patients or system users.

IQM User Reference Manual (v1.35a SW-v1.8) 1-1


Caution messages are shown in a black box, with a warning symbol (a black
exclamation point in a yellow triangle) at the left side. The text begins with the
title “Caution.”
Example:

Caution:
IQM can only monitor field deliveries for which the
corresponding treatment plan has been imported to the IQM
database.

1.3 Safety Signs & Symbols


The IQM Detector and the related accessories IQM Mount, IQM Transceiver and
IQM Service Dummy are all marked with product labels. The power supplies are
marked directly on the power supply and with labels indicating they belong to
the IQM. Each label is also marked with the mandatory “Read the
manual/instructions for use!” symbol.

More information about the symbols and information on the product labels can
be found in section 9 IQM Labelling.

1.3.1 “Refer to Instruction Manual” Symbols

“Follow instructions for use” - This symbol informs the user that it is mandatory to
read the instruction manual because there is important safety information
concerning that piece of equipment which is not obvious or part of the labelling
on the device. It is mandatory to consult the manual before using these items.

See section 1.4 for information about the location and availability of electronic
(PDF) copies of this manual ("electronic Instructions for Use" or "eIFU").

IQM User Reference Manual (v1.35a SW-v1.8) 1-2


“Caution - consult accompanying documents” symbol - This symbol indicates
the need for the reader to consult the accompanying documents for important
safety-related information such as warnings and precautions that cannot, for a
variety of reasons, be presented on the device itself.

“Consult instructions for use” symbol - This symbol indicates the need for the
reader to consult the operating instructions for information needed for the
proper use of the device.

1.3.2 Warning Symbols

“Warning – Danger of Electric Shock” Symbol - The “High Voltage” symbol


indicates the presence of components which carry high voltage (500v) which
pose a hazard of electrical shock. The symbol can be found inside the IQM
Detector. Do not touch anything inside the detector unless you are trained to
recognize which parts carry high voltage and whether high voltage is present.
Only persons trained and authorized by iRT shall open the IQM Detector.

IQM User Reference Manual (v1.35a SW-v1.8) 1-3


“Warning – Danger” - This warning symbol indicates a hazard that could cause
loss of life, major or minor harm to the patient or the system user (or other persons,
if applicable). It is accompanied by a text explaining the hazard.

1.4 Location and Availability of the Manual and Electronic


Instructions for Use (eIFU)
The IQM manuals are made available in an electronic version which fulfills the
regulatory requirements for "electronic Instructions For Use" (also called "eIFU"). It
is provided in electronic PDF document form and may be opened and read with
Adobe Acrobat Reader or any reader compatible with the PDF 1.4 format.

Adobe Acrobat Reader is pre-installed on the IQM Workstations. To download


the free Acrobat Adobe Reader application for viewing PDF files on other
computers, visit http://get.adobe.com/reader.

An electronic (PDF) copy of the manuals is available on the desktop of each


IQM Workstation. Either a shortcut to a central server location is provided, or a
copy is saved directly on the desktop of the IQM Workstation at the time of
installation. The manual is updated for each new software version, and the most
up-to-date PDF will be provided with the software release. Therefore, any time a
software update is applied to the IQM System, all manual PDF copies should be
replaced with the new, updated manual PDF from the software release.

It is recommended that an electronic (PDF) copy of the manuals be saved on


the desktop of any computer where IQM Review is installed, and that the
manual be updated any time the software is updated.

It is recommended to discard expired copies of the manual to ensure that all


users use the correct, current version of the manual.

To review whether the correct manual is available, compare the software


version given in the first chapter Applicability of the User Reference Manual with
the version shown in the info screen (click the “i” icon) of any IQM application.
Alternatively, browse to the IQM installation folder and view the “product
version” file property of any IQM executable. The version numbers should match
to the extent of the first two digits, e.g. 1.6.

IQM User Reference Manual (v1.35a SW-v1.8) 1-4


Users may print copies of the manuals for their own use for the purpose of
operating the IQM System. It is not permissible to supply the manuaIs to other
persons outside the user's hospital without permission of iRT Systems.

All IQM manuals are available for download to eligible users from the iRT website
www.i-rt.de/support-downloads. Contact iRT Support for information about
access details.

Users may request one print (paper) copy of the manual by contacting iRT
Support by email, phone or fax:

Email: support@i-rt.de
Telephone: +49(261) 91545-0
Fax: +49(261) 91545-99

IQM User Reference Manual (v1.35a SW-v1.8) 1-5


IQM User Reference Manual (v1.35a SW-v1.8) 1-6
2 About the IQM System

2.1 Medical Purpose & Main Features (Intended Use)


The IQM System allows independent verification of the linear accelerator
treatment delivery accuracy in radiation therapy.

Intended Use Statement

The IQM Integral Quality Monitor is a large-area ionization chamber intended to


be used for quality assurance verification measurements and documentation of
the treatment delivery accuracy (beam shape, position and dose) from medical
linear accelerators used for intensity modulated radiation therapy.

The data acquired by IQM is used to compare and verify a treatment dose
(delivered dose) to the expected dose and to compile treatment delivery
radiation beam data and consistency data over time as part of a quality
assurance program.

Device Description

The IQM System consists of an electronic detector device and software used to
control the device and to display the results. The verification of dose is based on
a realtime or near-realtime comparison of a measured or expected signal which
is proportional to a spatially dependent dose-area-product of the beam
monitored. IQM can be used for verification of treatments with therapeutic
photon beam radiation only. The verification of beam orientation is done using
a built-in inclinometer which monitors gantry and collimator angles of the Linac
and with data supplied by the therapy delivery system (linear accelerator).
Comparisons can be made and documented for quality assurance purposes,
and deviations from the expected signal can be detected and reported. Where
results can be presented on a segment by segment1 basis, the rapid reporting of
results may make it possible for the user to detect serious deviations during
treatment and interrupt treatment before a catastrophic dose is delivered to the
patient.

1 A beam segment is spanned by two consecutive control points. IQM only considers
segments where the beam is on, so the sequence of segment numbers for IMRT is usually
[1, 3, 5, …] (odd numbers) because [2, 4, …] are move-only segments. For VMAT, the
sequence is [1, 2, 3, …] because the Linac moves and delivers beam in both, odd and
even segments.

IQM User Reference Manual (v1.35a SW-v1.8) 2-1


The medical device can be used for monitoring or verifying the treatment of
humans and animals.

The IQM is designed to detect and report significant deviations from the
expected dose as prescribed by the radiation oncologist and calculated in the
treatment plan. The oncologist and the medical physicist specify the tolerances
defined as acceptable and the degree of deviations which should result in the
system alerting the user. The implementation of these ranges is made during
system installation, acceptance and commissioning by a designated
responsible staff member of the radiation therapy department (see section 3.2.2
Designation of a Designated Responsible User) together with an iRT Product
Specialist.

2.1.1 Only for Use by Trained Professional Users


The IQM System may be used and handled (installed, commissioned, attached,
detached, maintained) only by trained professional users instructed by iRT
Systems staff or qualified service partners of iRT Systems. As agreed with the site,
iRT Systems or a qualified service partner will train a designated responsible user
from the hospital who will be responsible for the ongoing training and supervision
of his or her department staff in use of the IQM after the initial commissioning and
installation (hereafter referred to as the designated responsible user).

2.1.2 Prescription Statement (per CFR 801.109(b)(1))


CAUTION: In the United States, federal law restricts this device to sale, distribution
and use by or on the order of a licensed physician.

2.2 Theory of Operations/System Overview


The IQM System consists of the data acquisition hardware of the measurement
system (detector and its ancillary components) and the IQM software
applications and requires for use (one-directional) interfaces to other systems in
the RT department and computer hardware implemented to run the IQM
software.

2.2.1 IQM Medical Electrical Equipment


The IQM has been designed and tested as a medical device. The IQM is defined
as consisting of the detector with power supply together with the IQM
Transceiver with power supply and serial cable. The IQM software is also
considered as part of the device (see Figure 1).

IQM User Reference Manual (v1.35a SW-v1.8) 2-2


The detector is attached to the linear accelerator using an integrated Linac
brand specific latching mechanism (IQMS) or a mounting adaptor (IQM Mount)
supplied by iRT.

The IQM Transceiver is installed in the treatment room, typically mounted on the
wall. Each IQM Detector is paired to a specific IQM Transceiver. The transceiver
is powered by a 5-6V power supply, depending on region/configuration. The
IQM Transceiver is connected to the computer configured as the IQM
Workstation in the control room by a serial cable, typically installed in a cable
channel in the bunker floor or wall.

For operation, the IQM requires computer hardware implemented as the IQM
Workstation, a USB to RS232 serial cable adapter and the IQM Server
implementation, which may be installed on server hardware supplied by iRT or
on server hardware provided by the user institution, if the specified minimum
hardware and configuration requirements are met. The USB to RS232 Adapter
supplied by iRT is mandatory for compliance with electrical safety requirements.
See section 3.3.5 for more information about electrical separation and safety.

The user is responsible for the safe use of the IQM together with the required
adapter and computer hardware and for continuing compliance with
regulatory requirements for safety and the IEC 60601-1 standard.

The IQM software is also part of the medical device and described in the
following section.

The classification of system components per IEC 60601-1 is summarized in the


following diagram (Figure 1, see next page).

IQM User Reference Manual (v1.35a SW-v1.8) 2-3


Classification of IQM components per the IEC 60601-1 MEE definition

Other ancillary utilities and


applications

IQM Mount accessory to detector, for Varian or Elekta


(Does not apply to IQMS Detector) Other ancillary utilities and applications

Figure 1 - The IQM consists of items defined as MEE medical electrical equipment
and other required items which are not defined as MEE

IQM User Reference Manual (v1.35a SW-v1.8) 2-4


The IQM database and IQM Calculator software are typically installed on server
hardware on the same network as the IQM Workstation, typically in the radiation
therapy department. Server hardware is not part of the medical electric
equipment (MEE) per the IEC 60601-1 definition. Server hardware is required and
supplied by iRT or the hospital as per the defined configuration. The server or
servers where the database or software services are installed are referred to
collectively as the "IQM Server" in this manual.

2.2.2 IQM Software Installation


The IQM software is based on Microsoft Windows .NET technologies (v4.6.1 or
higher) and is installed on current Windows operating systems (7, 8/8.1, 10).

The IQM software installation consists of IQM Monitor, IQM Calculator (short: IQM
Calc), IQM Review and the IQM Database which is implemented in a Microsoft
SQL Server environment together with ancillary utilities and applications.

The IQM Monitor software is installed on a computer, configured and referred to


as the IQM Workstation, in the linear accelerator control room. For each linear
accelerator outfitted with an IQM Detector, a computer configured as the IQM
Workstation running the IQM Monitor application is installed in the control room
for that linear accelerator.

The IQM Calculator (short: Calc) software and the IQM Database are installed
on a common virtualized server, referred to as the IQM Server. Alternatively, the
IQM Calc software and the database can be installed on separate virtualized
servers.
This server setup (one or two virtualized servers) may typically serve a department
with multiple IQM Detectors installed at multiple accelerators.

IQM Review is an application for reviewing the results, managing baselines


(reference data sets) for verification, making additional comparisons or statistics
and for generating reports. IQM Review may be installed on a computer outside
of the control room and outside of the controlled part of the radiation therapy
department, such as in the office of a medical physicist, with the agreement of
iRT Support and the hospital or clinic’s IT department. These computers are
referred to as IQM Review work spaces.

All computers (workstations and the server(s), as well as all computers running
IQM Review) that run any part of the IQM software need to be members of a
common Windows domain to use the Active Directory. Thus, file and database
access is controlled using domain authentication.

IQM User Reference Manual (v1.35a SW-v1.8) 2-5


See sections 3.4.4, 3.4.5 and 3.4.6 for information about computer equipment for
use with IQM.

2.2.3 Integration in the Radiation Therapy Department Network


The IQM cannot perform its measuring and monitoring function unless the IQM
has been correctly integrated into the Radiation Therapy treatment network.
IQM receives data from other systems but does not exchange data or send data
to the other systems.

Interface to the treatment planning system

The IQM must be integrated into the department network so that the IQM Calc
application can access treatment plans that are made available from the
treatment planning system. See 3.5.1 for more information about workflow and
network implementation options.

Interface to the linear accelerator control system

How IQM receives information from the Linac control system varies with the linear
accelerator model and implementation. Configuration details are finalized
during installation and acceptance. Contact iRT for more information if needed.

The IQM software receives information from the Linac over a one-direction
network interface: Each IQM Workstation is connected to the Linac network
using an Ethernet connection cable and receives data over a TCP/IP based
network stream. Depending on the Linac interface, IQM may be required to
register itself as a listener device before the interlock is cleared, but IQM never
sends any other information to the Linac.

Note: the IQM hardware does not send information to the Linac, but it is
recognizable by the Linac by means of the built-in coding recognition
connector in the detector enclosure / in the mount unit, see section 3.7.

2.2.4 How IQM Verifies Field Delivery


The IQM automatically monitors radiation therapy beam deliveries, measuring
the radiation delivered in each beam or beam segment, comparing the current
measurements to a calculated or measured reference, and informing the user if
the actual beam delivery varies from the planned delivery by more than a user-
controlled limit as defined in the software configuration files.

The measurements are taken by the detector, which mounts into place in the
Linac gantry head like an electron cone and may be left in place throughout
the treatment day.

IQM User Reference Manual (v1.35a SW-v1.8) 2-6


The IQM Monitor application unites the measurements reported by the IQM
Detector with the patient, field and segment information broadcast by the Linac
control interface to create a record of the delivery and perform realtime
verification - without any user interaction.

IQM monitors in one of three modes, depending on whether the patient and
field are “known” by IQM, i.e. a matching plan has been imported in the
database by IQM Calc, and whether a reference record exists against which
the signal being acquired can be compared.

1. Verification mode: If the treatment plan and a calculated or measured


reference record is available for the field being delivered, IQM runs in
Verification mode. The measured signal is compared to the reference
signal value found in the calculated or measured reference record for that
field. If the difference between expected and actual signal exceeds the
criteria defined by user, IQM alerts the user with a combination of audible
and visible alarms.
The evaluation of segment by segment and cumulative results is based on
the ‘Clinical Rules’, see section 6.1 Clinical Rules (Criteria settings for
Clinical Alerts & Alarms).
Also, for static and IMRT fields, the measured gantry angle is verified against
the gantry angle as defined in the treatment plan. For known VMAT fields
and for known Elekta non-VMAT fields, the nominal beam energy and
fluence mode broadcast by the linac are compared to the planned
nominal energy and fluence mode.
For information about how calculated or measured reference records are
handled, refer to section 4.1.3 Calculated versus Measured References.
2. Record mode: If no calculated nor measured reference record is
available for the field being delivered, but the plan was imported to the
IQM Database using IQM Calc, IQM runs in Record Mode. Although no
comparison is possible without a reference, the per-segment signals are
recorded to create a measured reference that will be used by default for
verification the next time this field is delivered.

Record Mode and criteria for recoding a new measured reference is


further discussed in section 4.1.3 Calculated versus Measured References.

3. Display mode: If the patient and/or field is not known (that is, have not
been imported to the IQM Database) then IQM Monitor runs in Display
mode.
No treatment record is created, but the signal counts for each segment
are shown onscreen, and the delivery is only logged in the IQM Monitor
application log file (logging is done in all modes).

IQM User Reference Manual (v1.35a SW-v1.8) 2-7


Note: The IQM signal is proportional to a spatially dependent dose-area-
product of the beam monitored.

IQM evaluates the signal for each segment against Clinical Rules that define
ranges for “scoring” deviations from the expected delivery. Clinical Rules
represent the user’s criteria for watch level alerts and action level alarms, with
separate watch and action criteria defined for individual segments and for
cumulative signals.

The designated responsible user is responsible for setting the percent deviation
thresholds that define these ranges. By default, the evaluation of the cumulative
signal is used to trigger alarms. The designated responsible user is further
responsible for establishing protocols for how staff should respond to watch level
alerts and action level alarms triggered by the Clinical Rules and other Clinical
Alarm conditions, like gantry angle deviations.

The Clinical Rules in IQM define three ranges for “scoring” signal deviations from
the expected delivery:

The Tolerance Range: The expected variation in machine output defines


the “Tolerance Range,” where the Linac is delivering the field as
expected. The Tolerance Range covers small deviations from the
reference signal that are a result of the Linac’s mechanical tolerances.
Signal deviations are in Tolerance Range if their absolute percent value is
smaller than the Watch Level value.

The Watch Range: Variations in the segment signals that are outside the
normal mechanical variation in Linac operation, but whose impact on
the patient’s well-being are clinically insignificant, fall in the Watch range.
By definition, these deviations do not warrant interrupting the treatment.
Signal deviations are in Watch Range if their absolute percent value is
larger than the Watch Level value but smaller than the Action Level
value.

The Action Range: Variations in the segment signals or cumulative signal


per field that, per the user's definition, are large enough to warrant an
alarm indicator allowing the user to immediately investigate or interrupt
the treatment fall in the Action range. These variations prompt IQM
Monitor to issue audible and visible alarms. Signal deviations are in Action
Range if their absolute percent value is larger than the Action Level
value.

IQM User Reference Manual (v1.35a SW-v1.8) 2-8


Caution:
IQM can only detect inter-segment errors, not intra-segment
errors. IQM can only detect errors in completed segments, not
in segments still in progress.

Monitoring is further described in chapter 4 and the implementation of the


Clinical Rules by the user is described in chapter 6.

2.3 Limitations and Exclusions, Contraindications

2.3.1 Only for use with Photon energy beams


Since the detector hardware is specific to the type of energy used by the Linac,
the IQM System is currently intended to be used only in combination with
therapeutic Photon radiation (i.e. not with therapeutic Electron beams,
therapeutic Proton beams or therapeutic particle beams as used in heavy-ion
therapy such as carbon-ion treatment).

2.3.2 Not for detecting errors in the treatment plan


IQM utilizes data from the treatment plan as provided by the treatment planning
system to calculate a reference signal. IQM is not intended to detect errors in
the treatment plan: Errors in the treatment plan that translate into errors in the
treatment delivery cannot be detected by the IQM System.

2.3.3 Not for detecting errors in patient identity, setup or position


The IQM monitors the radiation beam and cannot detect errors in patient
identity, setup or positioning. It does not read or monitor the position of the
treatment table or the patient.

2.3.4 Non-VMAT verification results delayed when used with certain


linear accelerator interfaces (Varian ADI)
IQM uses information concerning the current treatment session which is
broadcast over the RT network. Monitoring results are dependent on the
availability of the information. The Varian ADI interface does not broadcast the
segment start and segment end events until the end of field. IQM requires this
information to verify segment delivery for non-VMAT fields (e.g. Static or Step and
Shoot IMRT), so it cannot provide verification results for those fields until the
segment data is available at the end of the field.

IQM User Reference Manual (v1.35a SW-v1.8) 2-9


This means for treatments with Varian accelerators where fields, other than
RapidArc are monitored, IQM verification results are presented with segment by
segment level of detail for all segments at the end of each field, but not during
the field.

For all other configurations, IQM provides verification results on a segment by


segment basis during the field delivery, after each segment is completed.

See section 4.14 Special Considerations for Varian ADI users for information
about what monitoring and deviation information is available during delivery of
a field, and what deviation detection information is presented after the field is
completed.

2.3.5 Not for use with all linear accelerator interfaces


The medical device is only compatible with linear accelerators which implement
specific interfaces. These interfaces must be implemented during the IQM
System installation and include configuration files and hardware elements such
as network connections. The availability and proper functioning of the required
interfaces must be verified by the user together with iRT Support in the pre-
installation phase.

2.3.6 Not for use in surgical, oxygen-enriched or anesthesia


environments
The device is neither intended to be used in a surgical environment nor in an
oxygen-enriched environment in the presence of flammable anesthesia or other
flammable medical gasses.

2.3.7 No use with MRI


The IQM Detector contains stainless steel screws and may contain other ferrous
components and is not suitable for use with linear accelerators outfitted with MRI
(Magnetic Resonance Imaging) equipment.

2.3.8 Blind arc area at top of linear accelerator gantry


Within 2 degrees of the upmost and lower-most linear accelerator gantry
position, the IQM detector cannot detect the current gantry angle with the
same accuracy as in the other 352 degrees of rotation. Therefore, segments that
overlap this “blind” arc range are always grouped together during both
calculation and monitoring, and their collective signal is divided equally
between the grouped segments. Because the system always handles this blind
arc area the same way, monitoring results are still consistent. However, sensitivity
to positional deviations in this part of the arc is limited due to this technical
restriction.

IQM User Reference Manual (v1.35a SW-v1.8) 2-10


A site-configurable display rule allows the angle range of the blind arc area to
be adjusted, if desired.

See 6.2 Segment Merging and Smoothing Rules (in Configuration Settings) and
in section 6.2. Mandatory Segment Grouping (Merging) for information
concerning mandatory merge rules including merging around the blind arc and
6.4.1.7 Software Configuration File IQM.Config.ini for more information about the
blind arc area and the site-configurable range option.

2.3.9 Detection of deviations in collimator angle limited


Detection of deviations in the collimator angle is not supported by the current
version of IQM software.

2.3.10 Contraindication for use without ample clearance


Depending upon the linear accelerator model, the IQM or the handles of the
mount may extend beyond the touch guard of the linear accelerator. This
means that in case of a collision, IQM hardware may touch the patient before
the touch guard is touched and activated. Therefore, it is the responsibility of the
user to consider the geometry of the linear accelerator, the IQM, the patient
and the intended treatment and to determine whether there is any danger of
collision. The IQM may not be used in any treatment setup without ample
clearance between the Linac collimator and the IQM and the patient.

Treatments at shortened SSDs should be evaluated to determine if the change


in SSD affects the skin dose in a clinically significant way and whether a separate
modelling in the TPS is required. See 6.3.1 Implementing IQM Beam Attenuation
in Treatment Planning for more information.

IQM User Reference Manual (v1.35a SW-v1.8) 2-11


2.4 Safety Notices
Additional context specific warnings and safety notices are given directly in the
respective section within the User Manual.

1. Not for detecting errors in the treatment plan

Warning:
IQM utilizes data from the treatment plan as provided by the
treatment planning system to calculate a reference signal. IQM is
not intended to detect errors in the treatment plan. Errors in the
treatment plan that translate into errors in the treatment delivery
cannot be detected by the IQM System. Failure to verify the
treatment plan by other means may result in mistreatment, which
may result in minor or major side effects, including death.

2. Not for detecting errors in patient identity, setup or position

Warning:
The IQM system cannot detect errors in patient identity, setup or
positioning. It does not read or monitor the position of the
treatment table or the patient. Failure to verify the patient identity,
setup or positioning by other means may result in mistreatment,
which may result in minor or major side effects, including death.

3. Not for use in surgical, oxygen-enriched or anesthesia environments

Warning:
The device is neither intended to be used in a surgical
environment nor in an oxygen-enriched environment in the
presence of flammable anesthesia or other flammable medical
gasses. Use in the presence of flammable gasses may result in a
fire which may result in injury or death.

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4. IQM Detector only recognized by linear accelerator with IQM
Mount (not applicable to IQMS)

Warning:
The presence of IQM is only recognized correctly by the Linac by
means of the coding recognition part integrated into the detector
hardware. The coding recognition part is part of the Linac-brand-
specific IQM Mount supplied with the detector or is integrated
directly into the detector enclosure (IQMS Detector models).
The Linac interlock system reacts only to the presence of the
coding and has no facility to detect otherwise whether IQM is
present or not. The responsible user must ensure that staff do not
attempt to circumvent the Linac interlock system, such as using
the IQM Mount without a detector or service dummy attenuator
plate. Manipulation or misuse of the IQM Mount to circumvent the
Linac interlock system may result in mistreatment, which may result
in minor or major side effects, including death.

5. Do not attach or detach IQM in the presence of a patient

Warning:

Never attempt to attach or detach the IQM Detector (or mount


or service attenuator) at the Linac when a patient is on the
treatment table. The device could fall on the patient, causing
injury or death.

6. Use care when attaching IQM to the linear accelerator and ensure
that the device is properly fixed to the treatment machine.
Do not use the IQM if the mount or fixation hardware is damaged,
or not does not latch correctly

Warning:
Make sure that the IQM detector is latched securely at the
collimator before letting go of it. Observe the indicators provided
by the Linac (LED or audio signal). Pull gently on the device to
determine whether the fixation hardware is correctly engaged,
and if not, attach the device again. If the device is not latched
securely, it could fall out during treatment and onto the patient,
resulting in injury or death.

IQM User Reference Manual (v1.35a SW-v1.8) 2-13


Do not use the IQM if the mount or fixation hardware appears
damaged, or if the detector is not attached securely to the mount
(if applicable) or the latch mechanism does not engage as
expected.
Inspect the /device each time the device is attached or
detached from the linear accelerator and do not use if the device
appears damaged.
If the fixation hardware is damaged, or the detector is not
attached correctly to the mount, the device may fall off the Linac
and onto the patient, resulting in injury or death.

7. Do not use without taking the effect of the detector on the beam,
including beam attenuation, into consideration in treatment
planning

Warning:
The IQM Detector causes a beam attenuation for which the effect
on dose must be taken into consideration.
The effect of the detector in the beam path must be reviewed
and the clinical significance of the effect assessed by the user and
taken into consideration in treatment planning. Failure to correctly
take the effect on the beam into consideration in the treatment
plan may result in mistreatment, which may result in minor or major
side effects, including death.

8. Do not leave the cable attached to the detector when the Linac is
moving, or when a patient is present

Caution:
Only charge the device when it is not moving. Do not charge the
device when a patient is present or touch the patient and the
device at the same time.
Do not leave the cable attached if the linear accelerator with the
detector mounted is to be rotated. The movement of the cable
being dragged could pose a hazard if it is dragged across or
against other equipment, or if it comes in contact with a person.

IQM User Reference Manual (v1.35a SW-v1.8) 2-14


9. Always inspect the treatment setup to ensure that no collision
between the detector and patient is possible

Warning:
Always inspect the treatment setup and patient position before
treatment when IQM is in place to ensure that there is at all times
adequate space between the patient and the treatment delivery
system with the IQM installed. Depending on the orientation of the
table or the size or position of the patient, the detector mounted
on the Linac head could hit the patient before the collision
protection of the linear accelerator is activated.

10. The IQM contains a rechargeable lithium ion battery, observe all
cautions

Warning:
Danger of fire or explosion! Incorrect handling of batteries may
result in injury or death.
Observe all cautions and warnings as explained in chapter 8.6, in
8-8-8.11 and 8.14.
Only qualified and trained iRT service personnel, or qualified and
trained service personnel authorized by iRT, shall exchange the
battery.
Incorrect insertion by unqualified personnel may result in fire or
explosion which may cause injury or death.
The air transport of damaged lithium batteries is strictly prohibited.

11. Use only original power supplies supplied by iRT

Warning:
Only use the medical device power supplies supplied by iRT with
IQM. These have been tested and certified to IEC 60601-1 and
60601-1-2 (EMC) and offer 2 means of protection (MOPs) in
conformance with the medical standard. See chapter 3.13.

IQM User Reference Manual (v1.35a SW-v1.8) 2-15


12. Use a means of electrical separation, as supplied by iRT

Warning:
A separator device must be used to isolate electrically the IQM
Transceiver installed in the treatment room from the IQM
Workstation computer hardware installed in the control room for
electrical safety. The USB to RS232 Adapter supplied by IRT must
be used to connect the IQM Transceiver serial cable to the IQM
Workstation in the control room. It is mandatory for safety. See also
3.10.
Do not remove or disable this component.

13. Do not use electric equipment if wet or damp

Warning:
Do not allow the IQM hardware to become wet or liquids to enter
the devices. Danger of Electric Shock! See 8.12 Housekeeping &
Cleaning Recommendations for cleaning recommendations. If
liquid has entered into a device, it must be inspected by a
qualified person to ensure that the device is safe and has not
been damaged.

14. Do not use electric equipment if damaged

Warning:
Inspect IQM hardware including cables and connectors before
use and replace any damaged components. Do not use any part
of IQM hardware if it is damaged.

IQM User Reference Manual (v1.35a SW-v1.8) 2-16


2.5 Use Environment
The IQM data acquisition hardware is designed for use in a climate-controlled
radiation therapy department. The equipment has been designed and tested
for use under the following conditions:

• Temperature: 15 - 35 degrees Celsius


• Relative Humidity: 30% - 85% humidity
• Altitude: < 2000 m above sea level
• Mains Supply: 100 - 240V AC mains power (supplied via a separate
power supply with a region or country-specific plug)

Use or storage of the equipment under other conditions may damage the
equipment or be unsafe.

Like all dosimetry or measurement systems, the IQM will perform most accurately
when its data acquisition hardware is at room temperature and at thermal
equilibrium with its environment, see also Section 2.5.7 Using IQM at Thermal
Equilibrium.

Both detector and transceiver contain electric components and should not be
allowed to become damp or wet.

The IQM data acquisition hardware (IQM Detector and IQM Transceiver) are
rated for continuous use.

The IQM Detector is internally powered and classified as Class II equipment. The
IQM Transceiver is Class II equipment.

The emission characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A).

Note: The following statement is required in order to comply with the medical
EMC standard, although no use of the IQM System equipment is possible,
intended or permitted in a residential environment:

If it is used in a residential environment (for which CISPR 11 class B is required),


this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such
as relocating or re-orienting the equipment.

The IQM has been designed and tested for EMC and BLUETOOTH compatibility.
Nevertheless, it is necessary that the user observe equipment performance
carefully and, if needed, reposition equipment to ensure that the IQM and other
devices present do not interfere with each other. More EMC and Bluetooth
information may be found in chapter 7 EMC Declarations per IEC 60601-1-2
(Edition 4.0).

IQM User Reference Manual (v1.35a SW-v1.8) 2-17


2.5.1 Not for use in an Environment with Explosive Gases
The device is not intended for use in a surgical environment nor in an
environment with flammable or explosive gases in where quantities of these
gases are present such that there is the danger of explosion. No data is available
concerning the safety of using the IQM in such an environment.

Under some circumstances, portable or mobile systems used to assist patients


through the administration of oxygen or anesthesia may be permissible if the
responsible hospital staff has sufficient knowledge in the operation of these
systems and is able to determine whether there is any risk of explosion or
flammability when used in the treatment room. Professional users in the hospital
who possess the required authority and competency shall assess the safety of
the use of such systems where the IQM is installed and in keeping with their
institution’s procedures and risk management guidelines.

2.5.2 Use with Oxygen


The IQM System has not been designed or tested for use in an oxygen-enriched
environment where concentrations of oxygen are sufficient to pose a hazard of
explosion. No data is available concerning the safety of using the IQM in such
an environment. If patients or other persons are present who are using breathing
support systems which supply oxygen, take all necessary precautions to avoid
oxygen concentrations in the room which could pose a danger of explosion or
fire.

Professional users in the hospital who possess the required authority and
competency shall assess the safety of the use of such systems where the IQM is
installed and in keeping with their institution’s procedures and risk management
guidelines.

2.5.3 Use with Anesthesia


The IQM System has not been designed or tested for use in a surgical theater or
environment where anesthesia is used. No data is available concerning the
safety of using the IQM in such an environment. If patients or other persons are
present who are using systems administrating anesthesia, verify that these use
only non-explosive gases, and take all necessary precautions to avoid gas
concentrations in the room which could pose a danger of explosion or fire. The
IQM System may not be used in the presence of flammable or explosive gases
in quantities which could pose a risk of explosion.

Professional users in the hospital who possess the required authority and
competency shall assess the safety of the use of such systems where the IQM is
installed and in keeping with their institution’s procedures and risk management
guidelines.

IQM User Reference Manual (v1.35a SW-v1.8) 2-18


The power supplies supplied by iRT for use in the treatment room are all
“medical” power supplies and certified to IEC 60601-1, however, the IEC 60601-
1 standard as applied does not cover use with anesthesia or potentially explosive
gases.

2.5.4 No Use with MRI


The IQM Detector contains stainless steel screws and may contain other ferrous
components and is not suitable for use with linear accelerators outfitted with MRI
(Magnetic Resonance Imaging) equipment.

2.5.5 Safe Use in the Patient Environment


The IQM System is designed to be used in the proximity of the patient, however,
no contact between the IQM and the patient is necessary or allowed.

The IQM Transceiver is designed for use in the treatment room, typically mounted
on the wall. The IQM Transceiver must be positioned so that it is not in the
immediate proximity of the patient, that is, it should be located at least 1.5m
away from the treatment table (see diagram).

Warning:
Do not allow the patient to touch the IQM Detector or its
accessories.

The detector is mounted on the linear accelerator in the treatment room and
therefore in the direct proximity of the patient. It is the responsibility of clinical
staff to ensure that the patient does not attempt to touch or grab onto the
detector or linear accelerator.

Figure 2 - Example of a definition for the patient environment, taken from the safety
standard IEC 60601-1

IQM User Reference Manual (v1.35a SW-v1.8) 2-19


The computers used by the IQM System are not designed for use in proximity to
the patient. These must be installed in the linear accelerator control room, or in
the case of the server, in a different, appropriate room. Patients shall not have
access to any room where computers used with the IQM System operate.

Warning:
The operator may not touch the detector or its accessories,
(such as the mount, or the power supply) and the patient at the
same time.

2.5.6 Storage Environment


See 8.13 Maintenance & Service for information about how the IQM System is to
be stored.

2.5.7 Using IQM at Thermal Equilibrium


Like all dosimetry or measurement systems, the IQM will perform most accurately
when its data acquisition hardware is at room temperature.

In the case of first time installation it may be necessary to plan ahead in order to
achieve thermal equilibrium with the environmental conditions before the first
measurements. If the equipment has been received from a freight handler or
has been in storage then it may be substantially colder (or less frequently,
warmer) than the treatment room.

Bring all equipment into the treatment room before installation, preferably at
least a day in advance. Depending on the conditions of storage, 24-72 hours
may be required to bring equipment to room temperature.

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2.6 Accuracy & Precision of the Measurement System
The IQM is designed to be sensitive to deviations of each field or segment taken
as a whole. This means that very small deviations (such as a 2mm leaf
displacement over 1cm of the MLC bank) are detectable for small fields, where
they may be clinically important, while the same deviation occurring in a large
field, where it is less likely to be clinically significant, will typically result in a
deviation within the tolerance range for normal treatment machine and
measurement tolerances.

The IQM System is designed to detect, for a reference 10x10cm field:

• dose output variations or deviations in MU settings with a magnitude


greater than 2% and larger than the short-term system reproducibility
(typically>=0.5%), provided all other beam parameters remain constant
• changes of 1% or higher in the field intensity map due to incorrect
modifiers
• changes in beam placement: a 5mm error in leaf bank placement of
4x4cm field shall translate into a 1% (or greater) change in IQM signal,
provided all other beam parameters remain constant
• changes in gantry angle of the linear accelerator during data
acquisition, within 3 degrees, except in the areas of 0° +/- 2° and 180°
+/- 2° (the “blind arc” region, see section 6.2.1). For static fields outside
of the blind arc region, deviations from the expected gantry angle of
more than 1° are detected
It is important that the responsible medical physicist understands the
measurement sensitivity characteristics of the IQM and evaluates their usefulness
and implementation in the treatment workflow. Furthermore, the responsible
medical physicist must define the ‘Watch’ and ‘Action’ levels as well as the
gantry angle tolerances and similar parameters applied by the system
accordingly, and determine their meaning for the department staff and
workflow (see also section 3.2.4 Department Policy for Reaction to IQM
Messages and Warnings).

2.6.1 Signal Counts unit of measure


The IQM measures and compares “Signal Counts”, an abstract unit integrating
various aspects of dose at a moment in time. Signal counts, abbreviated as
“signal”, are proportional to a spatially dependent dose-area-product of the
beam monitored. E.g., the signal of a 10x10 field with 100MU delivered with 6MV
typically lies in the range between 200.000 and 300.000, depending on the
machine output calibration method applied to the linear accelerator. IQM uses

IQM User Reference Manual (v1.35a SW-v1.8) 2-21


this unit to compare the current beam with references which were previously
measured or calculated by IQM.

Signal counts cannot be converted to Grays or any radiological unit of measure


and are only used for IQM’s internal verification processes.

Temperature and barometric pressure are recorded by the IQM during signal
measurement for its internal correction of signal count values. The values
measured are not for use in other systems or calculations and may yield incorrect
results if used for other purposes than intended.

2.7 Not Intended to Replace Absolute Dosimetry Systems


The IQM System is designed for comparative measurements for verification
purposes. It is not designed for absolute dosimetry and is not intended to replace
absolute dosimetry measurements performed with other measurement systems.

IQM User Reference Manual (v1.35a SW-v1.8) 2-22


3 Implementing IQM

3.1 Installation & Training


The installation of the IQM System is performed by iRT staff or authorized
distributors who are qualified and authorized to do so.

During commissioning and installation, the institution shall ensure that persons
with the appropriate competency and authority participate in the installation
and training. A designated, responsible user shall be present during the
installation and acceptance procedure who can operate the accelerator and
who may sign the acceptance documents on behalf of the institution.
Furthermore, a designated responsible user must be present to implement the
settings for the deviation levels which IQM should report to the user as “Clinical
Alarm” warnings. See the sections 3.2 Responsibility of the User and the User
Institution and 3.3 Information for Persons Responsible for the Network and IT
Installations for more information about the role and responsibility of the
designated responsible user.

The commissioning and installation is documented in the Acceptance Protocol.


Training of the designated, responsible user (often the medical physicist) is part
of the installation. Training in routine functions affecting all users such as those
routinely delivering the treatments (radiation therapists) is typically made after
the installation and commissioning activities recorded in the Acceptance
Protocol.

It is recommended that as many users as possible participate in the training, see


also 3.2.1 Importance of Staff Training.

Other users in the department may be trained by the designated, responsible


user if so agreed between iRT and the hospital.

3.1.1 Availability of Technical Documentation Concerning Installation


The user should contact iRT Support if assistance is required for verifying the
installation in the future, or some part of the installation set up must be repeated.
iRT Support staff can supply guidance and documentation to aid the user or
other hospital staff responsible for maintaining the IQM System in managing or
validating the system installation.

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3.2 Responsibility of the User and the User Institution

3.2.1 Importance of Staff Training


In general, a distinction is to be made between users who operate the system in
the treatment routine and users who are responsible for the implementation of
clinically significant settings, system QA and system maintenance. Therefore,
training which accompanies the installation of the IQM can be organized to
address routine operational tasks separately from advanced tasks.

Routine tasks include attaching and detaching the detector, observing whether
the IQM System is available for monitoring, monitoring treatments and attaching
the power supply to the detector to recharge the battery each day after patient
treatments have been completed, and similar tasks.

Advanced tasks are typically only performed by designated members of the


department, typically medical physicists, and include the configuration of the
Clinical Rules which implement the tolerances and acceptable/not acceptable
deviation criteria which should result in “clinical alarms,” as well as duties such
as performing periodical QA on the system, and to perform software updates
and system backups, etc.

Training of at a minimum the designated, responsible user (often the medical


physicist) is part of installation and made in parallel to the installation. Training in
routine functions affecting all users such as those routinely delivering the
treatments (radiation therapists) is typically made after the installation and
commissioning per see has been completed, as documented in the
Acceptance Protocol. It is recommended that as many users as possible
participate in the training.

3.2.2 Designation of a Designated Responsible User


During commissioning and installation and acceptance, the institution shall
ensure that persons with the appropriate competency and authority participate
in the installation and training.

Each hospital or clinic using IQM shall designate a responsible user who shall
serve as the primary contact for iRT and who takes responsibility for the training
and supervision of all users of the IQM System in the department after the initial
installation and commissioning.

The IQM detector attenuates the beam and this attenuation must be taken into
consideration when calculating the prescribed dose in treatment planning. The
responsible hospital medical physicist is responsible for how evaluating how IQM
affects the beam and for determining how this is best taken into consideration in
treatment planning. See also 6.3 Treatment Planning Considerations for IQM.

IQM User Reference Manual (v1.35a SW-v1.8) 3-2


Furthermore, at least one member of the staff must be competent and
authorized to implement, define and configure the tolerances and
acceptable/not acceptable deviation levels which should result in “Clinical
Alarms,” in keeping with the department’s treatment and risk management
policies or guidelines. The responsible hospital staff must determine who is
authorized to make these decisions and to implement changes in the IQM
configuration files, and must ensure that this is known and implemented in the
department.

3.2.3 Ongoing Training & Supervision of Users within the Department


A responsible member of the RT department is designated to supervise and train
other users in the department on the correct and safe usage of the IQM System
in the future. This designated responsible user is typically a medical physicist with
detailed knowledge both about the IQM System and about the workflow and
procedures of the department. For example, new radiation therapists must be
shown how to attach and detach the detector, and instructed about the
importance of having the detector in place if a treatment has been planned
with the correction for detector beam attenuation, all users must be instructed
how to recognize if the system is available for monitoring, the cleaning staff
advised not to spray water into or at the measurement device, etc. See also
Appendix 3 Recommendations for Training.

3.2.4 Department Policy for Reaction to IQM Messages and Warnings


IQM issues “Clinical Alarms” when the measured signal deviates from the
expected signal by more than a deviation limit configured by the responsible
user. Responsible staff members must decide how their staff is to react to a
“Clinical Alarm” and train their staff accordingly. This policy must be developed
and maintained by responsible members of the radiation therapy department.

The IQM can present a warning but does not interrupt or intervene in the
treatment directly. The safety benefit of using the IQM can only be realized when
staff is aware of and trained to react to information presented by IQM.

3.2.5 Maintaining Conformity with Safety Standards


This device has been designed and tested to ensure compliance with the
standard for medical electrical equipment, IEC 60601-1, and collateral
standards such as the EMC standard IEC 60601-1-2. IT equipment used with the
IQM must comply with the standard or with the standard IEC 60950-1 or IEC
62368-1 which is (the successor standard to IEC 60950). The user must ensure that
all equipment is used in compliance with the respective standards, as well as
any local laws, and that equipment is only installed or connected in compliance
with the standards and in accordance with the manufacturer’s instructions.

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3.2.6 Defining Department Protocols with IQM
The IQM Detector can be used for a variety of QA activities as it allows fast and
accurate capture and comparison of beam deliveries.

For comparisons to be useful it is important that comparable setups of


equipment are ensured.

Consistent measurement setup is essential for all verification activities. In


particular, when using IQM for any QA purpose it is essential to clearly define
whether the detector is to be removed or mounted for any baseline QA
measurement. It must be ensured that the presence or absence of IQM be
carefully documented in department protocols or procedures and involved staff
trained accordingly. For example, when defining machine QA protocols, it must
be clear to participating staff which machine QA measurements are to be
performed with IQM in place and which measurements are to be made without
IQM. If baseline measurements are conducted with IQM in place it must be clear
which measurement must be likewise conducted with IQM in place, otherwise
the resulting measurements will be outside of the expected range. Likewise,
where baseline measurements are taken without IQM, care must be taken to
remove IQM for the corresponding measurements.

3.3 Information for Persons Responsible for Network and IT


Installation

3.3.1 Changes in the IT Network, Update of Interfaced Systems &


Analysis of Related Risks
The information in this section is for the persons or entity responsible for the
network and IT Installations at the user’s institution.

The integration of the IQM into the clinical network is validated at the time of
installation.

If changes are made to the clinical IT network on which the IQM system is
installed, including changes to other equipment on that network, the responsible
institution must ensure that the implementation remains safe and that the IQM
System and all equipment in the clinical network continue to perform correctly
and safely.

Connection of the IQM to other IT Networks including other equipment may


result in previously unidentified risks to patients, users, other persons or
equipment. The responsible institution has the responsibility to identify, analyze,
evaluate and control these risks.

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If new or different equipment is integrated into the clinical network, the
responsible institution must ensure that the IQM and all other systems on the
networks continue to function correctly.

Changes to the IT Network might include:

• changes in network configuration, e.g. change of DNS server, IPs, or


domain controllers,
• connection of additional devices (including but not limited to, treatment
equipment, information systems, measurement systems, etc.),
• disconnection of devices (as above),
• updates or upgrades of equipment, with or without software,
especially updates or upgrades of the linear accelerator software, or the
treatment planning system software.

Changes to the network could introduce new risks. The responsible institution has
the responsibility to identify, analyze, evaluate and control these risks, in
accordance with the medical safety standard IEC 60601-1.

3.3.2 Validation of the Installation after IT Changes


When changes are made to the IT Network, or the systems from which IQM
receives information, such as the treatment planning system or the linear
accelerator control system, the responsible institution has the responsibility to
ensure that the system continues to function as expected. It is recommended
that the user compare the system behavior before and after the changes, for
example by comparing the results of a monitoring session made before the
changes and the results obtained in a monitoring session for the same treatment
made after the changes. The user is free to choose the type of plan and method
for the tests. For example, the QA Plan as applied during the installation and
acceptance of the system could be repeated. A description of the QA Field Test
plan may be found in the appendix for reference.

Users are encouraged to retain records of the repeated QA measurements or


tests performed and to share these with iRT Support for review.

3.3.3 Prohibition against using Wireless Connections for IQM Installations


Do not install IQM components on computers using wireless connections to
transfer data. It is not permitted to send any data containing personalized
patient information over wireless connections. Furthermore, laws and regulations
in your region or country may forbid the transmission of personalized patient
data over wireless connections.

If the user institution has implemented a wireless network with safety controls
which permit sending patient data over the wireless network securely in

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compliance with local law, the user may install the IQM Review application on
computers which use wireless connections, upon their own responsibility and
authority. Contact iRT Support for more information.

3.3.4 Installing or Changing Software on Computers Used with IQM


The IQM Workstation is delivered pre-configured for use with IQM and intended
as a dedicated computer resource for IQM. The configuration may not be
changed without permission from iRT Support. Changing the configuration or
installing other software on the workstation may prevent IQM from functioning
properly.

Computer equipment supplied by the hospital for use with IQM, such as server
hardware (if an IQM Server from iRT is not installed) or other computers where
the IQM Review application is used, must be maintained by knowledgeable staff
as designated by the hospital. Knowledgeable persons must ensure that if
changes are made to the computers, or other software installed, that these do
not compromise the correct functioning of IQM. In the same manner, they are
responsible to ensure that the IQM components and other software or items do
not interfere with each other or pose any hazard.

See chapter 8.5 Data Backup for recommendations about sufficient disk space
for correct system performance.

3.4 Overview of IQM Components


The IQM hardware and software are installed and configured during IQM
installation by iRT or by persons trained and authorized by iRT to perform
installation, such as an authorized distributor or service representative. The user
shall not attempt to install or configure the IQM unless trained and authorized to
do so.

3.4.1 IQM Data Acquisition Hardware


An overview of the IQM, its hardware and software components and the
available accessories is given in section 2.2.1 IQM Medical Electrical Equipment.

The data acquisition hardware is typically delivered in special cartons with


protective foam inserts. It is recommended to keep the white cartons and inserts
after installation, in case a component must be returned to iRT for service (see
section 8.2).

The data acquisition hardware consists of the IQM Detector and an IQM
Transceiver. The detector is attached to the Linac collimator with integrated
fixation hardware (IQMS models) or with the separate IQM Mount supplied by

IQM User Reference Manual (v1.35a SW-v1.8) 3-6


iRT. One set of data acquisition hardware is installed per Linac treatment
machine and room and includes the following:

IQM Detector with 15V power supply for charging the detector. See section 3.13
for mandatory instructions and warnings about the power supply. Typically, one
IQM Mount accessory is delivered per detector. Mount accessories are
accelerator manufacturer-specific and further described in sections 3.6.

IQM Transceiver installed in the treatment room (typically mounted on the wall).
Each IQM Detector is paired to a specific IQM Transceiver. The transceiver unit
includes a serial cable and a 5V or 6V power supply; the model depends on the
country/region configuration. See section 3.13 for mandatory instructions and
warnings about the power supply and section 3.10 for mandatory instructions
and warnings about the USB-to-RS232 serial cable adapter used for electrical
separation for safety.

3.4.2 IQM Software & System Architecture


The IQM software is based on Microsoft Windows .NET technologies and is
installed on current Windows operating systems.

The IQM software installation consists of the three applications IQM Monitor, IQM
Calculator (short: IQM Calc) and IQM Review, and the IQM Database which is
implemented in a Microsoft SQL Server environment.

Computers used with the IQM may not be installed in the treatment room or in
the patient environment. Only computers which comply with the international
safety standard IEC 60950-1 or 62368-1 such as those supplied by iRT may be
used with IQM.

3.4.3 IQM Monitor, IQM Calc, IQM Review and IQM Database
The IQM Monitor software is installed on the IQM Workstation in the linear
accelerator control room. For each linear accelerator outfitted with an IQM
Detector, a computer configured as the IQM Workstation running the IQM
Monitor application is installed in the control room for that linear accelerator.

The IQM Calc software and the IQM Database are installed on a common
virtualized server, referred to as the IQM Server, unless the local IT environment
makes separate virtualized servers for these two components desirable.
This virtualized server setup can support a department with multiple IQM
Detectors installed at multiple accelerators.

IQM Review is an application for reviewing the results, managing baselines


(reference data sets) for verification, making additional comparisons or statistics
and for generating reports. IQM Review may be installed on any computer

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outside of the control room and outside of the controlled part of the radiation
therapy department, such as in the office of a medical physicist, agreed
between iRT Support and the hospital or clinic’s IT department. These computers
are referred to as IQM Review work spaces.

See section 3.4.5 below for the technical requirements for computers that run
IQM Review.

All computers (including workstations and the server(s), as well as all computers
running IQM Review) that run any part of the IQM software need to be members
of a common Windows domain (Active Directory). File and database access is
controlled using domain authentication.

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3.4.4 IQM Workstation
iRT supplies the IQM Monitor software on a computer with a touchscreen which
complies with the international safety standard IEC 60950-1, configured as the
IQM Workstation. Computers used with the IQM may not be installed in the
treatment room or in the patient environment (medically used area).

The IQM Workstation is installed in the Linac control room. The workstation
computer should be positioned so that the user can see the screen while
operating the Linac control console.

Figure 3 IQM Monitor Workstation 'Desktop' display, before the Monitor application is started
(example, actual screen display may vary)

3.4.4.1 IQM Workstation Cable Connections


There are sockets for 3 required connections on the back of the IQM Workstation.
During use, three cables are connected to that computer:

• Power cable connected to mains power supply


• Ethernet Network cable connected to the department network
• USB-RS232 Adapter connected to the IQM Transceiver by serial cable

Once the IQM Workstation is installed, these cables should remain connected.

IQM User Reference Manual (v1.35a SW-v1.8) 3-9


USB-RS232 Adapter (USB port)
Power Cable Ethernet Cable
for connection to the serial
(RJ45)
cable to the IQM Transceiver

Figure 4 Connections at the workstation computer

All required sockets are located at the back of the workstation:

2 2
1

Figure 5 Connections on the IQM Workstation: 1) Power Connector, 2) USB Ports and 3) RJ45
Connector

During installation and configuration activities, a USB keyboard and mouse may
also be connected to the IQM Workstation, otherwise the IQM Workstation is
operated using the touch screen.

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3.4.5 Computers Used with IQM Review
IQM Review may be installed on a computer outside of the control room and
outside of the controlled part of the radiation therapy department, such as in
the office of a medical physicist.

The computers used to run the IQM Review application to review monitoring
results and create reports should fulfill the following requirements:

• integration in the RT network and member of the same Windows domain


(Active Directory) as the IQM servers and workstations – for
communicating with the IQM Server and authenticating connections to
the IQM Database
• OS: Windows 7, 8, 8.1 or Windows 10 (32-bit or 64-bit, 64-bit
recommended)
• .NET Framework version 4.6.1 or higher
• processor: 1 gigahertz (GHz) or faster (32-bit or 64-bit processor, 64bit
recommended)
• RAM: 2 gigabyte (GB) RAM (32-bit) or 4 GB RAM (64-bit)
• hard disk space: 5 GB available hard disk space
• graphics card: DirectX 9 graphics device
• display resolution: 1280 x 720 pixels or higher
The hospital or clinic determines the safety requirements for computers which
belong to the hospital on which IQM Review may be installed. iRT recommends
using only computers which are IEC 60950-1 / 62368-1 compliant.

Responsible hospital staff should determine which persons shall have access to
the IQM Review application and who will perform which activities within Review.
During installation, the IQM Database is configured so that only users who are
members of an IQM Active Directory Security Group such as
“IQMREVusersGroup” have permission to access the database. If a user who is
not a member of this group attempts to start the Review application, an error
message will be presented and the application will not start. For more
information about IQM Active Directory Security Groups see section 3.5.1.1.

Th IQM Review application typically runs on computers maintained by the


hospital. The user should ensure that the responsibilities and roles for updating
the Review software, for updating the operating system on the computer used,
in particular for security updates, and for installing and using a virus scanner are
determined and applied in keeping with the institution’s IT, cybersecurity and

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data protection policies. The user should contact their hospital’s IT department
or IT personnel as applicable.

3.4.6 IQM Server


Server implementations vary between hospitals and the configuration is
determined before IQM installation. By default, one or two virtual machines
running Microsoft Windows Server 2012 R2 and SQL Server 2014 Express are
configured to host the IQM services and the IQM Database. The virtual
machine(s) may be pre-installed on server hardware provided by iRT, or on
existing server hardware. For details concerning the options available for
implementing IQM on server hardware, contact iRT Support.

3.4.7 IQM Detector Service Attenuator (Dummy)


The IQM Detector Service Attenuator (or "Dummy") is an optional accessory for
the IQM. The service attenuator may be purchased or borrowed from iRT as part
of a service order. See chapter section 8.7 Use of the IQM Detector Service
Attenuator / Dummy for information.

3.5 Integration in the Radiation Therapy Department Network

3.5.1 RT Department Network and Active Directory Integration


The IQM workstations and servers need to be integrated in the RT department
network and in a common Active Directory as a pre-requisite for sharing data,
accessing the IQM Database, receiving Dicom RT plans, communicating with
the linac, and other functions required by the IQM system. Computers intended
for running IQM Review need to be integrated in the same Active Directory.

The RJ45 network connector of the IQM Workstation (see 3.4.4) is used for
connecting the workstation to the network switch of the linear accelerator which
it is configured to monitor. The connector is intended only to be used for the
connection to the RT department network for clinical purposes. No other cable
attachment or network connection shall be implemented.

The network and Active Directory integration is site-specific and performed by


iRT installation staff in cooperation with department IT during installation.

3.5.1.1 Use of the Active Directory Users and Groups


Before or during installation, specific Active Directory Users and Security Groups
are implemented in the department active directory by department IT so that
IQM can rely on the Windows Integrated Security technology for application
and database authentication.

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Note: If a site does not have an active directory system in place, or if access to
the active directory is not permitted, IQM is usually delivered with a hardware
server, including a domain controller which establishes an active directory for
use by the IQM system. In this case, users and groups are pre-configured.

Assignment of users to these groups is the responsibility of department IT, usually


the domain administrator.

Security Groups:

• IQMmedphysGroup – members are medical physicists who have


permission to edit the Clinical Rules in the IQM.Config.ini file.
• IQMREVusersGroup – members are all users who are allowed to execute
IQM Review; Review allows all users to change the baseline for a field (see
section 5.3.6), so only users granted this permission may be member of this
group.
• IQMMONuserGroup – members are all users who are allowed to run IQM
Monitor, i.e. who log on at an IQM Workstation.

Users:

• IQMserveradmin – iRT support account, configured as an admin user on


IQM computers with full control.
• IQMuseradmin – account for the designated responsible user who is
trained to change IQM software settings and Clinical Rules in the
IQM.Config.ini file on all IQM computers, perform software updates (if so
instructed by iRT Support), and create SQL backups.
• IQMMONuser (member of IQMMONuserGroup) – generic user account
which can be used to automatically log in to the IQM workstations and
run IQM Monitor, if no personalized user accounts can or should be used
for IQM.

3.5.2 Interface to the Treatment Planning System


The IQM Calc application needs to receive or retrieve treatment plans from the
treatment planning system (TPS) so that it can import the plans. Two different
implementation options are available as described in the following.

3.5.2.1 Configure IQM as a Dicom Receiver at the TPS


The standard (preferred) method to interface the Treatment Planning System
(TPS) is to configure IQM as a DICOM node at the TPS. During system installation,
the TPS is configured with the IQM System as a new (destination) node for Dicom
export (default AE Title: IQMPLANS).

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When Dicom RT plan files are exported to the Linac control system, the planning
staff also send them to IQM. A Dicom Receiver program running on the IQM
Server receives and stores the Dicom RT plans in a local folder and makes them
available to the IQM Calc Service for automatic import and calculation.

3.5.2.2 Export Dicom RT Plans to a shared folder on the network


Alternatively, an existing Dicom node may be used and configured at the TPS so
that Dicom RT Plans are written to a network location configured for read and
write access by the IQM Server. IQM Calc Service monitors this folder and
automatically imports and calculates plans as they become available without
active user involvement.

Note: The IQM software deletes plans after successful import and moves plans
that could not be imported to another folder. During setup, it needs to be
ensured that the user running IQM Calc Service has the required permissions on
the chosen network location, and that no other devices access the location.

No direct connection between IQM Server and the treatment planning system
is necessary when using this interface. However, the computer where the
network folder is located must be turned on, and may need a specific user to
be logged in, for the Dicom service used by IQM to receive plans and share
them with IQM.

3.5.3 Interface to the Linear Accelerator Control System


To perform its measuring and monitoring function, the IQM needs to be correctly
integrated into the Radiation Therapy treatment network for communication
with the linear accelerator as described in section 3.5.1.

The network integration is site-specific and performed by iRT installation staff.

The IQM receives information from the Linac over a one-directional network
interface provided by the Linac manufacturer. Information about the current
patient and beam, the Linac’s current position, state, etc. is broadcast to all
connected client devices. IQM does not send any information to the Linac.

In case of Varian linear accelerators, IQM needs to be configured as a client at


the Varian ADI interface console. This is done during installation by providing the
IQM-specific client ID and description. Every time IQM Monitor is started and
connects to the ADI server, the software provides the same details to register at
the server as a known client. Otherwise, a “Device Not Connected” interlock
would prevent beam delivery.

Configuration details are finalized during installation and acceptance. Contact


iRT for more information if needed.

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The IQM Mount includes a hardware interface which connects with the Linac
system when being attached to the Linac head. The hardware interface
transmits a simple code so that IQM is recognized by the Linac coding
recognition connector, as described in section 3.7. The IQM Mount does not
send any other information to the Linac.

3.5.3.1 Linear Accelerator Types Supported


The IQM is designed and tested by iRT for use with and to work correctly with
Varian brand and Elekta brand linear accelerators.

IQM is designed to support all Elekta brand linear accelerators using the ICOM
network communication protocol.

IQM is designed to support all Varian brand linear accelerators using the ADI
network communication protocol and providing either Trajectory Log or
Dynalog files to third party QA devices via a network share.

Note: automated reference calculation from the treatment plan requires MLC
and energy specific commissioning. Contact Support for information about a
specific MLC and energy.

At the time of publication of this manual, iRT Systems has tested IQM with the
following accelerator types:

Elekta
Elekta Versa HD™
Elekta Infinity™
Elekta Synergy® / Synergy® Platform
Elekta Precise Treatment System™

Note: IQM cannot be used with the "AGL Accelerated Go Live" beam model as
provided by Elekta as the standard AGL beam model does not account for the
effect of IQM on the beam.

Note: The use of IQM with iViewDose has not been validated by Elekta or
approved by Elekta. The presence of the detector in the beam can affect
imaging taken with the detector in place. The user must evaluate the impact of
IQM on the imaging and whether IQM and iViewDose are to be used at the
same time.

Elekta is not responsible for the operation or testing of IQM or its compliance with
safety and regulatory standards. iRT Systems as manufacturer of the device is
solely responsible for compliance with safety and regulatory standards and

IQM User Reference Manual (v1.35a SW-v1.8) 3-15


certifies that IQM has been developed and tested to comply with the applicable
safety and regulatory standards.

Varian
Varian TrueBeam™ Radiotherapy System
Varian Trilogy® System
Varian Clinac® iX (requires activated custom coding)
Varian C Series (requires activated custom coding)

Varian is not responsible for the operation or testing of IQM or its compliance with
safety and regulatory standards. iRT Systems as manufacturer of the device is
solely responsible for compliance with safety and regulatory standards and
certifies that IQM has been developed and tested to comply with the applicable
safety and regulatory standards.

Correct operation with the installed equipment at the user’s site is validated at
installation.

If the user intends to use IQM in a different configuration than that which was
validated at installation, iRT Support must be contacted for information. If the
user intends to use the IQM with a linear accelerator not previously tested,
contact iRT Support to determine how use of IQM with the particular linear
accelerator can be tested.

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3.5.4 IEC 61217 coordinate system
The IQM software uses the IEC 61217 coordinate system as used in the Dicom RT
standard.

The IQM Monitor application displays information about the gantry angle and
the collimator rotation in the “Planned Geometry” Group using the IEC
coordinate system:

Figure 6 "Planned Geometry" group in IQM Monitor

This may mean that the presentation of the beam aperture in IQM may not be
the same as the presentation in other applications, such as the view presented
by the record and verify system or the treatment planning system, if these
present the view in a different native coordinate system. For example, MOSAIQ
and Elekta consoles may present in the Elekta native coordinate system, also
referred to as the bipolar coordinate system. The labelling of collimator jaws and
leaves will be different in this case.

The jaw and leaf positions presented in the Planned Geometry group are based
on the treatment plan and known adjustments applied by the linear accelerator
and the corresponding record and verify system (“as treated” configuration
versus “as planned” based only on the treatment plan). The Planned Geometry
display should match the display in the record and verify system.

The user should familiarize themselves with the display in IQM Monitor to ensure
that the display is being correctly interpreted, and any differences to the display
presented by other systems is understood.

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3.6 Fixation Hardware - Attaching the IQM Mount to the IQM
Detector
The detector is attached to the Linac collimator with integrated fixation
hardware (IQMS models) or with the separate IQM Mount supplied by iRT.

3.6.1 Attaching the IQM Mount (not applicable for IQMS)


For configurations where a separate mount is supplied, the detector is typically
attached to the mount at the time of installation and remains attached for
normal use. To connect the mount to the detector, place the mount on the
detector and secure it with the 8 screws as depicted in the figure below. When
correctly installed, the mount and detector surfaces should be flat against each
other.

Figure 7 - Screws for fixing the IQM Mount. Note the code recognition connector on the right.
(shown here: IQM Mount for Elekta)

Note: Once the mount is attached to the detector, it should be left attached.
The mount is only removed for service reasons, such as to exchange the battery
in the detector. Do not detach the mount from the detector unless instructed to
do so by iRT Support staff. If it is necessary to detach and reattach the mount,
do so with great care because an incorrectly installed detector may result in

IQM User Reference Manual (v1.35a SW-v1.8) 3-18


poor measurements or be a safety hazard if the detector is not correctly
attached to the mount.

Warning:
Applies to detectors supplied with a separate IQM Mount unit:
Do not use the IQM if the detector is not attached securely to the
IQM Mount with all 8 screws. When correctly installed, the mount
and detector surfaces should be flat against each other. Inspect
the detector and mount each time the device is attached or
detached from the Linac head and do not use if these appear
damaged.
If the mount is damaged, or the detector is not attached correctly
to the mount, the device may fall off the Linac and onto the
patient, resulting in injury or death.

3.7 Attaching and Detaching IQM at the Linac


The IQM implements a large ion chamber and is opaque to light. Therefore,
remove the detector if the use of the light field is desired or necessary to set up
and control patient positioning. Use the handles to pick up and transport the
device.

The detector (or detector with mount, if mount is supplied and attached as
described in the previous section 3.6) is attached to the Linac by sliding it into
the accessory slot until it clicks into place, like an electron cone. To detach the
detector, use the thumb lever or levers to release the latch mechanism and
carefully slide the detector out of the collimator ring on the linear accelerator.

Warning:
Make sure that the IQM is latched securely on the collimator
before letting go of it. Observe the indicators provided by the
Linac (LED or audio signal). Pull gently on the device using the
handles to determine whether the fixation mechanism is correctly
engaged, and if not, attach the device again. If the device is not
latched securely, it could fall out during treatment and onto the
patient, resulting in injury or death.

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Warning:

Never attempt to attach or detach the device at the Linac when


a patient is on the treatment table!

Warning:
Do not use the IQM if the detector (or mount, if applicable)
appears damaged. If the detector is supplied with a separate
mount, do not use if the detector is not attached securely to the
mount. Inspect the detector (and mount) each time the device is
attached or detached from the Linac and do not use if these
appear damaged.
If the detector or mount is damaged, or the detector is not
attached correctly to the mount, the device may fall off the Linac
and onto the patient, resulting in injury or death.

3.7.1 Detector Recognition for Elekta and Varian Accelerators


The IQM is equipped with a code recognition part which allows the Linac control
system to identify which device is currently attached to the treatment machine.
The code recognition part serves only to identify the presence of the IQM to the
Linac. No data is transferred between the Linac and the IQM over the code
recognition part, in either direction.

The code assigned to IQM must be entered in a treatment plan intended to be


delivered with IQM in place, mounted at the linear accelerator, i.e. in the beam.
If the treatment delivery system detects a mismatch between the code as
entered in the plan and the code that is read from the detector hardware
attached to the accelerator, the treatment delivery system will present an
interlock, inhibiting the delivery of radiation.

The code recognition connector is automatically engaged when the IQM is


attached to the Linac. There are no parts for the user to connect. Do not attempt
to attach any other plug or cable to the code recognition connector on the
mount.

The code recognition connector is specific to linear accelerator manufacturer


brand.

IQM User Reference Manual (v1.35a SW-v1.8) 3-20


Figure 8 - Code recognition connector on the IQM Mount. The connector engages
automatically with its counterpart in the Linac collimator when the Mount is attached.
Do not attach anything else to the code recognition connector.

Listen and look for signs that the detector is securely latched in place. You should
feel and hear the latch mechanism snap closed when the device is properly
installed. Pull gently on the mount to determine whether the latch is correctly
engaged, and if not, re-attach the device.

For Elekta accelerators, a loud tone is made by the linear accelerator interlock
system beginning at the moment that the mount is inserted into the accessory
slot. When the device is correctly engaged, the tone will stop.

For Varian accelerators, an LED illuminates red when the linear accelerator
interlock system registers that an accessory is being put into the accessory slot.
The LED changes to green when the device is correctly engaged by the linear
accelerator accessory slot mechanism.

3.8 Setting up Patient Treatments Safely when IQM is Installed


The detector is mounted within the touch guard system of the linear accelerator
. The detector is several centimeters thick and in the case of some physical touch
guard rings (such as Elekta Agility) protrudes out beyond the touch guard. This
means that for some positions where the treatment table is raised or rotated (not
at the home position of 0 degrees, parallel to the axis of rotation) or where a
patient is large, the detector could hit the patient before the touch guard system
is activated.

IQM User Reference Manual (v1.35a SW-v1.8) 3-21


Therefore, it is required to inspect the position of the treatment table and the
patient when controlling the patient setup, to ensure that the detector will not
touch the patient when the Linac rotates around the patient.

Warning:
When the IQM is in place, always inspect the treatment setup and
patient position before treatment to ensure that there will be
adequate space between the patient and the Linac head (with
the IQM installed) at all treatment table and gantry positions that
are part of the treatment. Depending on the orientation of the
table or the size or position of the patient, the detector mounted
on the Linac head could hit the patient (or table or other
equipment) before the collision protection of the touch guard is
activated.

Particular treatment techniques may require special review or consideration with


respect to monitoring with IQM, see 6.3 Treatment Planning Considerations for
IQM.

3.9 Installation of the IQM Transceiver in Treatment Room


The IQM Transceiver is installed in the treatment room and is paired with the
specific IQM Detector unit installed in that treatment room.

The transceiver communicates with the IQM Detector wirelessly using the
BLUETOOTH standard, and with the IQM Workstation via an RS232 serial cable.

Figure 9 - IQM Transceiver, mounted on the wall

IQM User Reference Manual (v1.35a SW-v1.8) 3-22


The IQM Transceiver should be installed by hanging it on the wall near a cable
conduit and near a wall socket for mains power supply. The IQM Transceiver is
mounted to the wall with a screw.

The transceiver must be installed outside of the patient environment (that is,
positioned at least 1.5m away from the patient treatment position, see section
2.5.5 and the figure below).

Ensure that the transceiver unit is not placed where it might be in the primary
beam of the linear accelerator when it performs a full gantry rotation.

Figure 10 - Safe positioning for the IQM Transceiver. Position the transceiver so that it is not in the
path of the primary beam, also during rotation of the treatment machine, as represented by the
dotted line along the interior of the treatment room

It may be advantageous to test locations for good communication between the


components before securing the unit to the wall. The nominal transmission range
for the transceiver is 10 meters. Positioning within the “line of sight” is generally
not required but may improve communication if the connection seems
problematic. Similarly, positioning the transceiver so that it is not more than 10
meters away from the detector will ensure continuous connection during
monitoring.

Caution:
No monitoring is possible if the wireless connection between the
detector and the transceiver is not functioning or is interrupted.
Verification measurements may be interrupted or be incomplete
if the connection is lost during the treatment measurement session.

IQM User Reference Manual (v1.35a SW-v1.8) 3-23


Ensure that the IQM Transceiver is located in an appropriate
location as described in section 3.9 of this manual.
If communication errors are presented (see section 3.12) check
the location of the transceiver and verify that the transceiver is
turned on (3.9.1).
If communication errors persist, contact iRT Support for assistance.

Incorrect positioning of the transceiver may result in communication errors if a


continuous connection between detector and transceiver cannot be
maintained. If the connection is lost, IQM will attempt to restore the connection.
If unsuccessful, IQM will present an error message on screen in the IQM Monitor
software.
If detector communication errors are presented by the IQM software (see 3.12),
repositioning the transceiver may improve the connection. If detector
communication errors persist, contact iRT Support for assistance.

3.9.1 IQM Transceiver Connections and Indicators


The connections and indicator lights on the IQM Transceiver unit are described
below.

Figure 11 - IQM Transceiver, with cover removed to show connections and LED indicators

The IQM Transceiver has two LED Indicators, labeled “Bluetooth” and “Power.”

The “Power” LED lights up whenever the power supply is connected and the
power switch is flipped to “On”.

The “BLUETOOTH” LED indicates whether the BLUETOOTH connection has been
established to the Detector. Both LEDs “Bluetooth” and “Power” are lit when the
IQM Transceiver is ready for monitoring. In routine operation, however, the LEDs
on the bottom of the transceiver are not visible. Instead, the user should check
the LEDs on the front of the detector. The LED on the front of the detector marked
with the BLUETOOTH symbol is the user’s indicator that the connection is available
and ready for monitoring (see section 4.3 Detector Ready and Other Detector
Indicators for more information)

IQM User Reference Manual (v1.35a SW-v1.8) 3-24


The power switch is on the far right and labelled Off/On.

The power supply connection is located on the far left behind the transceiver
enclosure cover. Only use the original power supply as delivered by iRT with the
IQM (see 3.11 for more information and cautions about using power supplies.)

The RS232 serial cable connection is also located behind the IQM Transceiver
cover and labelled with the serial port symbol and the text label “RS232”.
Once installed, the serial cable remains connected to the IQM Transceiver.

3.10 Serial Cable & Electrical Isolation of Connections


The serial cable is used for connecting the IQM Workstation to the wall-mounted
IQM Transceiver. Once installed, the serial cable remains connected to the IQM
Transceiver. The cable should be installed in the floor or wall conduits. It is
recommended to use clips or a cable conduit material to secure the exposed
portion of the serial cable where it lies over the wall or floor up to the cable
conduit wall or floor opening.

iRT provides standard serial cable kits in the lengths 15m, 25m/23m and 30m. In
general, the shortest cable of sufficient length should be used, and no more
cable than necessary left exposed in the treatment room outside of the
provided conduits, in any case less than 5 meters. See chapter 7 for more
information about cables and ESD concerns.

Warning:
A separator device must be used to electrically isolate the IQM
Transceiver installed in the treatment room from the IQM
Workstation computer hardware installed in the control room
for electrical safety. The USB to RS232 Adapter supplied by IRT
must be used to connect the IQM Transceiver serial cable to
the IQM Workstation in the control room.
Do not remove or disable this component.

Do not use damaged cables. If cables appear damaged these must be


replaced before use.
The supplied USB-to-RS232 Adapter ensures the electrical separation between
the computer equipment located in the control room and the IQM Transceiver
and serial cable, located in the treatment room, and therefore in the medically
used area. The use of the USB to RS232 Adapter supplied by IRT is mandatory for
compliance with electrical safety requirements. Do not remove or disable this
component.

IQM User Reference Manual (v1.35a SW-v1.8) 3-25


3.11 IQM Transceiver and IQM Detector Connection
The BLUETOOTH modules of the IQM Detector and the wall-mounted IQM
Transceiver are already paired with each other when delivered from the factory.

Once installed, the IQM Transceiver unit may be left on. In this case, turn on the
IQM Detector by pressing the power switch on the front of the detector (see
photo in section 3.9, far right) and wait for the IQM Detector and IQM Transceiver
to establish the BLUETOOTH connection. This may take as long as 60 seconds. Once
the connection has been established, both the BLUETOOTH LED on the IQM
Detector and the BLUETOOTH LED on the connector panel at the base of the IQM
Transceiver unit are illuminated.

Note: The BLUETOOTH LED on the IQM Transceiver connector panel is not visible in
normal use, since the connectors, LEDs and power switch at the base of the unit
are located behind the enclosure apron.

In routine use, the LED indicator marked with the BLUETOOTH symbol on the IQM
Detector indicates to the user that the connection has been successfully
established.

Figure 12 - Bluetooth indicator on front of IQM Detector

If the IQM Transceiver has been turned off, flip the switch on the bottom of the
unit to turn on the transceiver.

3.12 Verifying Communication between Workstation & Detector


To check if the communication between the IQM Workstation and IQM Detector
is working, start the IQM Monitor software. In the status area at the bottom left of
the display an IQM Detector Status field indicates if the connection to the IQM
Detector is available or not: field label “OK” and grey = available, yellow =
connection failed temporarily and may recover automatically, orange =
connection failed, configuration needs to be reviewed.

IQM User Reference Manual (v1.35a SW-v1.8) 3-26


Figure 13 - Verifying the connection to the IQM Detector in Monitor. Indicator fields in grey
indicate that performance is as expected

If communication with the detector is successfully established, the IQM Detector


Status indicator will be shaded grey. At the detector, the BLUETOOTH LED should
be lit green as shown in Figure 12.

If communication with the detector cannot be established or is intermittent,


resulting in the display as shown in the following figures, repositioning the
transceiver may correct the problem (see chapter section 3.12).

Figure 14 An intermittent communication Figure 15 When communication to the


error may clear itself (IQM Detector Status detector cannot be established due to a
indicator field is yellow) configuration problem which IQM cannot
resolve, the IQM Detector Status indicator
field is shaded orange and the Air Pressure,
Temperature and Battery information is
unavailable

IQM User Reference Manual (v1.35a SW-v1.8) 3-27


3.13 Power Supplies

Warning:
Only use the medical device power supplies supplied by iRT with
IQM. These have been tested and certified to IEC 60601-1 and
60601-1-2 (EMC) and offer 2 means of protection (MOPs) for
electrical safety in conformance with the medical standard.

iRT provides power supplies which have been tested for safety and certified to
the applicable international standards (IEC 60601-1 and the related national
standards) for IQM data acquisition components in the treatment room. For
computer components in the control room, iRT provides computers with original
power supplies certified to IEC 60950-1 / 6386862368-1 (internal or external power
supplies, depending on computer model).

The medical power supply supplied with IQM has been tested and certified to
IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Always use the original power
supplies as supplied with IQM to power IQM components in the treatment room.

Caution:
Always use the power supply with the proper plug (adapter) for
the country in which it is being operated.
Always plug the power supply into a grounded mains supply.
Connect the power supply to mains in such a way that the power
supply remains accessible and can be easily unplugged if
needed.

The IQM is supplied with two power supplies, a power supply to be connected
to the IQM Detector for charging the battery (15V) and a power supply for the
IQM Transceiver (5.9V). The power supplies for the IQM Detector (15V) and the
IQM Transceiver (5.9V) are different and NOT interchangeable. Do not mix or
confuse the power supplies.

The IQM power supplies are rated for mains power: 100-240V.

Power supplies must be plugged into a grounded mains supply for safety
reasons. The power supply must be equipped with the proper plug (adaptor) for
the country in which it is being operated. If the correct country-specific plug has
not been provided, contact iRT to order and receive the correct plug.

IQM User Reference Manual (v1.35a SW-v1.8) 3-28


If you are unsure whether the plug provided is correct for your country, contact
iRT or another suitable expert to determine whether the plug is correct.

If the power supply is to be replaced, contact iRT for a replacement or for


instructions and the correct power supply specifications. Only specific power
supply models have been tested and authorized by iRT for use with the IQM
System and it is required to use these models.

For information about how to charge the detector, see section 4.13.

IQM User Reference Manual (v1.35a SW-v1.8) 3-29


IQM User Reference Manual (v1.35a SW-v1.8) 3-30
4 Monitoring Treatments with IQM

4.1 How IQM Verifies Field Delivery


The IQM automatically monitors radiation therapy treatments, measuring the
radiation delivered in each segment, comparing the measurements to a
calculated or measured reference, and informing the user if the actual
treatment varies from the planned treatment beyond a user-defined tolerance
level.

The measurements are taken by the IQM Detector, which mounts into place in
the accelerator gantry head like an electron cone and may be left in place
throughout the treatment day.

The IQM Monitor application unites the measurements reported by the IQM
Detector with the patient, field (beam) and segment information broadcast by
the Linac control interface to create a record of the delivery - without any user
interaction.

4.1.1 IQM Modes of Operation


IQM monitors in one of three modes, depending on whether the patient and
field are known, and whether a reference record exists to compare against.

1. Verification mode: If the treatment plan and a calculated or measured


reference record is available for the field being delivered, IQM runs in
Verification mode. The measured signal is compared to the reference
signal value found in the calculated or measured reference record for that
field. If the difference between expected and actual signal exceeds the
criteria defined by user, IQM alerts the user with a combination of audible
and visible alarms.
The evaluation of segment by segment and cumulative results is based on
the ‘Clinical Rules’, see section 6.1 Clinical Rules (Criteria settings for
Clinical Alerts & Alarms).
Also, for static and IMRT fields, the measured gantry angle is verified against
the gantry angle as defined in the treatment plan. For known VMAT fields
and for known Elekta non-VMAT fields, the nominal beam energy and
fluence mode broadcast by the linac are compared to the planned
nominal energy and fluence mode.
For information about how calculated or measured reference records are
handled, refer to section 4.1.3 Calculated versus Measured References.

IQM User Reference Manual (v1.35a SW-v1.8) 4-1


2. Record mode: If no calculated nor measured reference record is
available for the field being delivered, but the plan was imported to the
IQM Database using IQM Calc, IQM runs in Record Mode. Although no
comparison is possible without a reference, the per-segment signals are
recorded to create a measured reference that will be used by default for
verification the next time this field is delivered.

Record Mode and criteria for recoding a new measured reference is


further discussed in section 4.1.3 Calculated versus Measured References.

3. Display mode: If the patient and/or field is not known (that is, have not
been imported to the IQM Database) then IQM Monitor runs in Display
mode.
No treatment record is created, but the signal counts for each segment
are shown onscreen, and the delivery is only logged in the IQM Monitor
application log file (logging is done in all modes).

4.1.2 IQM Clinical Rules for Scoring Deviations


IQM evaluates the signal for each segment against Clinical Rules that define
ranges for “scoring” deviations from the expected delivery. Clinical Rules
represent the user’s criteria for watch level alerts and action level alarms, with
separate watch and action criteria defined for individual segment and for
cumulative signals.

The designated responsible user is responsible for setting the percent deviation
thresholds that define these ranges. By default, the evaluation of the cumulative
signal is used to trigger alarms. The designated responsible user is further
responsible for establishing protocols for how staff should respond to watch level
alerts and action level alarms triggered by the Clinical Rules and other Clinical
Alarm conditions, like gantry angle deviations.

The Clinical Rules in IQM define three ranges for “scoring” signal deviations from
the expected delivery:

The Tolerance Range: The expected variation in machine output defines


the “Tolerance Range,” where the Linac is delivering the field as
expected. The Tolerance Range covers small deviations from the
reference signal that are a result of the Linac’s mechanical tolerances.
Signal deviations are in Tolerance Range if their absolute percent value is
smaller than the Watch Level value.

The Watch Range: Variations in the segment signals that are outside the
normal mechanical variation in Linac operation, but whose impact on
the patient’s well-being are clinically insignificant, fall in the Watch range.
By definition, these deviations do not warrant interrupting the treatment.

IQM User Reference Manual (v1.35a SW-v1.8) 4-2


Signal deviations are in Watch Range if their absolute percent value is
larger than the Watch Level value but smaller than the Action Level
value.

The Action Range: Variations in the segment signals or cumulative signal


per field that, per the user's definition, are large enough to warrant an
alarm indicator allowing the user to immediately investigate or interrupt
the treatment fall in the Action range. These variations prompt IQM
Monitor to issue audible and visible alarms. Signal deviations are in Action
Range if their absolute percent value is larger than the Action Level
value.

Watch
Range
threshold

Action
Range
threshold

Figure 16 - Illustration of Tolerance, Watch and Action Ranges. The Tolerance range is shaded
green. The Watch range is shown in white, between the green shaded Tolerance range and red-
dotted Action Range threshold. Any measurement falling outside the Action range threshold
dotted line will prompt a Clinical Alarm.

Thresholds must be set for the evaluation of cumulative results, which represent
the total accumulated dose of the field. Additional threshold values may be
defined for segment by segment evaluation, as determined by the user.

IQM can only detect inter-segment errors, not intra-segment errors. IQM
evaluates each segment when it is deemed to be completed in that segment
end information is available. IQM can only detect errors in completed segments,
not in segments still being measured.

IQM User Reference Manual (v1.35a SW-v1.8) 4-3


Caution:
IQM can only detect inter-segment errors, not intra-segment
errors. IQM can only detect errors in completed segments, not
in segments still in progress.
A Linac fault which occurs in a segment that is never completed
might not be detected and reported by IQM because IQM can
evaluate the segment only after it has been completed.

4.1.3 Calculated versus Measured References


If the treatment plan and a Calculated or Measured Reference record are
available for the field being delivered, IQM runs in Verification mode.

Once the IQM Calc software for generating calculated references has been
commissioned, a Calculated Reference will typically be generated
automatically each time a field is imported by IQM. This Calculated Reference
is used for the first monitoring session.

After the first monitoring session, the record of the first measurement (taken while
being verified against the calculation, if a calculated reference was present) is
automatically set as the Measured Reference, and all subsequent
measurements will be verified against this Measured Reference.

Note: Generally, it is assumed that Measured References will typically be more


representative than Calculated References, and IQM will always verify against
the most recent Measured Reference as soon as one is available, unless the user
explicitly selects another or has configured the system always to use the
Calculated Reference. If desired, the user may manually select the treatment
record against which subsequent deliveries of this field should be verified using
the Review application, see 5.4 Setting the Baseline for Future Deliveries of a
Field. To configure whether a new Measured Reference should be created the
first time each field is monitored, created every time the field is monitored, or
never created, see 5.4.3 Setting an Update Strategy for Measured Reference
Records.

Note: The user may choose to manually re-activate the Calculated Reference
record as the baseline. However, as soon as a new delivery that meets the
criteria below is recorded, that record will automatically be used as the new
Measured Reference for subsequent monitoring, unless the user again chooses
a different record as baseline. To always use the Calculated Reference as
baseline, set the Update Strategy never to create Measured References.

IQM User Reference Manual (v1.35a SW-v1.8) 4-4


4.1.3.1 Criteria for Recording Measured Reference Records
The first measured signal record is automatically saved as a Measured Reference
record unless:

1. the treat record is incomplete, i.e. the delivery was interrupted


2. there were system errors presented during the delivery
3. an action-level deviation (‘alarm’) occurred during delivery
4. the reference update strategy is configured not to create measured
references (see section 5.4.3)

Note: Watch level deviations in a treatment record do not affect the automatic
application of the record as a new Measured Reference.

In any of these instances, if IQM has a Calculated Reference, this reference will
be used as monitoring baseline again the next time this field is delivered. If no
Calculated Reference is available, IQM will run in Record Mode the next time
this field is delivered and will attempt to record a new Measured Reference
again.

If desired, the user may manually select a record where an action-level


deviation has been recorded as the Measured Reference by going to the
Review application, selecting that treatment record and clicking on the [Select
Baseline] button. Incomplete (partial) fields or errored fields may not be
manually selected as a baseline.

As soon as a Measured Reference record is available for a field, it is


automatically set as the monitoring baseline for subsequent deliveries of this
field.

If the user chooses to set the Calculated Reference as baseline again, then IQM
will save the treatment record from the next delivery as a new Measured
Reference (see criteria at beginning of this section) and will set the new
Measured Reference as the baseline, unless the reference update strategy is
configured not to do so.

4.1.3.2 Monitoring in Record Mode


If a treatment plan is available, and no Calculated Reference has been
generated (because IQM Calc has not been commissioned, for example), and
no previously measured reference record is available for the field being
delivered, IQM runs in Record Mode and automatically records a Measured
Reference. The first recorded Measured Reference will automatically be used as
the baseline reference for verification in subsequent deliveries of the field.

IQM User Reference Manual (v1.35a SW-v1.8) 4-5


4.2 Daily System Startup
To set up the IQM for daily operation, begin with the IQM Detector in the
treatment room.

The detector will typically be plugged in to charge its batteries overnight.

Caution:
Use only the original power supply to charge the detector (see
3.13 Power Supplies).

Unplug the detector from its power supply. The power connection is centered at
the back of the detector.

Figure 17 Rear view of the IQM Detector, showing power connection in center

Figure 18 For IQMS, the power connection is at the back of the detector, just off center

Note: It is not possible to turn on the detector when the power supply is attached.
See section 4.13 for more information about charging the detector.

IQM User Reference Manual (v1.35a SW-v1.8) 4-6


The IQM is attached and detached to the linear accelerator like a standard
electron cone. The detector is equipped with integrated fixation hardware
(IQMS) or supplied with a special fixation accessory (IQM Mount) for the given
linear accelerator model (see section 3.6).

If not already mounted to the gantry, attach IQM to the linear accelerator.

Observe the linear accelerator indicators for correct fixation, such as the tone
which changes when the mount latch is successfully engaged, or the change
of the LED on the accelerator head from red to green (indicator types vary
between Linac brands and models). Observe whether the device is installed
squarely and securely in the accessory slot. Do not proceed if the device
appears to be crooked, or hangs at an angle, or if the expected indicators at
the accelerator are not seen or heard.

Warning:
Make sure that the IQM is latched securely on the collimator
before letting go of the equipment.
Do not let go if the device appears to be crooked or hang at an
angle or if the expected indicators are not seen or heard. If not
properly engaged the device may fall off the linear accelerator
head. Re-attach the device and verify that the device is securely
attached. If the device cannot be attached correctly, remove it
from the linear accelerator and contact iRT Support.

Warning:
Do not use the IQM if the detector (or mount) appears damaged.
If the detector is supplied with a mount, only use if the detector is
attached securely to the mount.

Warning:
Do not attach or remove the device while the patient is on the
treatment table!

IQM User Reference Manual (v1.35a SW-v1.8) 4-7


Figure 19 – The IQM Detector attached to the accelerator

4.3 Detector Ready and Other Detector Indicators


Turn the detector on by pressing the power button centered on the front. Note
the Battery, Electrometer, Inclinometer, and BLUETOOTH LED indicators next to the
power button.

Figure 20 - LED Indicators on the front of the IQM Detector (IQM, top, IQMS, bottom)

LED indicators lit in green indicate that the relevant system component is
available and active. LED indicators lit in other colors (or not lit) indicate that the
relevant system component in not available and/or not active.

For instance, if the battery is close to running out of charge, the Battery LED will
be lit in yellow or red (see Table 1).

Caution:
Do not stare at the LED indicators or look at them for a long
period of time from a close distance. Staring at an LED can
damage your vision permanently.

IQM User Reference Manual (v1.35a SW-v1.8) 4-8


When the detector is ready for use, the power button, BLUETOOTH, and
Inclinometer LEDs will all be steadily lit in green and Battery LEDs will be lit green
or yellow, consult Table 1 for the meanings of the colors of the battery LED.

Table 1 - Colors and Meanings of LED Indicators on the IQM Detector

LED Color Meaning

Battery Green Battery has sufficient charge available for


monitoring and is ready for use
Blue Battery is charging

Yellow Caution - Battery is low


The user must take prompt action to recharge the
battery to ensure continued operation of IQM for
the next treatment (battery charge for less than
120 minutes of monitoring remains).
Red Warning - Battery is too low for monitoring
The user must take immediate action and
recharge the battery to ensure that monitoring is
possible Given the current level of battery
charge, IQM will not monitor the next treatment
(i.e. less than 30 minutes of charge remains).
Flashing Warning- Battery is too low for monitoring and the
Red detector is shutting down
The detector is now going to turn itself off to
prevent excessive depletion of the charge, in
order to protect the battery and to maintain
safety (i.e. less than 5 minutes of charge remains.)
The user must take immediate action and
recharge the battery otherwise no monitoring is
possible; IQM will not monitor the next treatment
with the current battery level.
Note: When less than 1 minute of charge remains,
the detector automatically powers off.
Electrometer Green The electrometer (measurement) electronics are
active (i.e. high voltage is on and signal
measurements are being taken) and ready for
polling, i.e. acquiring data.
This LED should remain steadily green when the
IQM Detector is powered on.

IQM User Reference Manual (v1.35a SW-v1.8) 4-9


LED Color Meaning

Unlit The electrometer is not active. There may be a


problem with the electrometer electronics.
Inclinometer Green The inclinometer is active and ready to detect
the gantry angle. This LED should remain steadily
green so long as the IQM Detector is powered on.
Unlit The inclinometer is not active. There may be a
problem with the inclinometer.
BLUETOOTH Green The BLUETOOTH connection between detector and
the external (wall-mounted) IQM Transceiver is
active and ready for use. This LED should remain
steadily green when the IQM Detector is
powered on.
Unlit No connection has been established between
the IQM Detector and the IQM Transceiver.
Note: It may take up to one (1) minute for the
Bluetooth connection to fully initialize after
turning on the IQM Detector.
If the detector’s BLUETOOTH LED remains unlit after
1 minute, check that the IQM Transceiver unit
(typically mounted to the wall) power is plugged
in and turned on.

Power Button Green The button is illuminated when the detector is


on.
In On/Ready for Use mode, the pushbutton and
all other LEDs are illuminated green.
In Standby mode, only the power button is
illuminated. The measurement electronics are
powered on with low voltage in order to support
better measurement response (IQMS only).
If the pushbutton LED is not on, the detector is in
Off mode, ready to be shipped or stowed for
longer periods.

Pushing the power button once will turn on the device for normal use. The 4
function LEDs will illuminate within several seconds.

Pushing the power button again will put the detector in Standby mode, suitable
for storage overnight (IQMS only).

IQM User Reference Manual (v1.35a SW-v1.8) 4-10


Pushing the power button steadily for 2 seconds will turn off the device
completely, suitable for long-term storage and required if the device is to be
shipped. The Off mode is required when performing for any hardware service
action.

IQM User Reference Manual (v1.35a SW-v1.8) 4-11


4.4 Starting the IQM Workstation & Authorized Permissions

Caution:
The IQM Detector cannot take measurements unless the IQM
Monitor software is running.

Caution:
The IQM Monitor software cannot evaluate the field delivery
unless a treatment plan containing the field being delivered has
been imported into the database with IQM Calc.

In the control room, turn on the IQM Workstation computer using the push-button
switch on the side of the monitor.

The IQM workstation can be configured so that the Monitor application will start
automatically at system start-up. Alternatively, an Active Directory user who is a
member of the IQMMONuserGroup needs to log in so that IQM Monitor will have
the required permissions to access the IQM Database.

The IQM Monitor application can also be started by double-clicking on the


Monitor icon on the desktop or in the taskbar.

4.5 Importing Dicom RT Plans to the IQM Database

4.5.1 Sending Dicom RT Plans to IQM


As described in section 3.5.2 Interface to the Treatment Planning System, a
Dicom destination node is configured at the TPS for the IQM System. Planning
staff needs to be trained to send approved plans both to the linear accelerator
and to the IQM system.

Caution:
It needs to be ensured that after revision of a treatment plan,
the plan is sent to IQM again, so that IQM always has the latest
version of the plan. The IQM software cannot detect whether
there should be a “newer” version a treatment plan version -
when a field is loaded at the linac console, IQM loads the most
recently imported plan from the IQM Database containing the
Patient ID and Field ID broadcast by the linac.

IQM User Reference Manual (v1.35a SW-v1.8) 4-12


4.5.2 Automatic Import of Dicom RT Plans to the IQM Database
The IQM Calc Service program is installed on the IQM Server and runs in the
background. The service retrieves new Dicom RT plans from the “Imports” folder
every minute, imports them into the database, and calculates reference records
for each imported field. Errors during startup, import or calculation are reported
to the Event Log of the server (Windows Logs → Application). For example, if
Calc Service stops because the “Imports” folder is not accessible, a new error
level Event Log entry will be written. See section 4.5.3 below for how to view Calc
Service Event Log entries.

The IQM Calculator software imports all valid Dicom RT Plan files in chronological
order, by the date and time they were stored in the folder. This is typically the
order in which plans were sent to the DICOM destination configured for use by
IQM.

Caution:
IQM only monitors fields for which the approved plan has been
sent to IQM and successfully imported by IQM Calculator.

Invalid Dicom RT Plan files, such as a file in the ”IQM_Imports” folder that is NOT
a Dicom RT Plan file, or a Dicom RT Plan file that does not contain the tags or
values required by IQM, where none of the planned fields can be imported, are
moved to an “IQM.Failed.Imports” sub folder inside the “Imports” folder. An error
event will be added to the Windows event log, and the IQM Calc application
log file will show that the particular plan file or single invalid fields were skipped
during import, e.g. ‘File […] contains non-PHOTON fields; skipping entire file’.

It should be ensured that new Dicom RT Plans are imported to IQM before they
are used to treat patients, because IQM can only monitor fields that exist in the
IQM Database.

4.5.3 Displaying the Calc Service Event Log


Since services run in the background, no visual feedback is available about the
service’s success or failure. However, the following items are logged for IQM Calc

IQM User Reference Manual (v1.35a SW-v1.8) 4-13


Service in the ‘Windows Event Log’, viewable using the ‘Event Viewer’ utility on
the Server:

Event description Level Event ID


Service started Information Undefined (0)
Service stopped Information Undefined (0)
Import or calculation thread Error 1001
ended with error
Unspecified general failure Error Undefined (0)

To open the Windows Event Viewer in Windows Server 2012 R2, right-click the
Start button and select “Event Viewer” from the menu. The Windows Event
Viewer will appear:

Figure 21 Using the Windows Event Viewer

In the ‘Windows Logs’ branch of the navigation tree at the left of the Event
Viewer screen, select “Application”, then sort the event list in the right pane by
“Source.” Look for entries with source “Calc31Service.” The logged events will
appear in chronological order, and double clicking any event shows details
about it.

IQM User Reference Manual (v1.35a SW-v1.8) 4-14


The Event Log can also be used to configure tasks that are triggered by new
event entries of the same type:

1. Navigate to the event which should be associated with a specific task,


e.g. a task with Source = Calc31Service, Event ID = 1001 (import or
calculation errors).
2. Right-click the event and select “Attach Task to This Event”.
3. Perform each step presented by the “Create Basic Task” Wizard.

For example, an administrator may choose to configure a script that sends an


email every time such an error entry appears in the Event Log. For more
information, please contact iRT Support.

4.5.4 Starting and Stopping Calc Service


Although IQM Calc Service is configured to restart automatically when an error
occurs, it may happen that the error situation does not clear itself. If the
configuration needs to be changed and the configuration file IQM.Config.ini file
updated, e.g. if the location of the “Imports” folder was changed, the Calc
Service application needs to be restarted.

To open the Task Manager in Windows Server 2012 R2, right-click on Start and
select “Task Manager” in the menu. Navigate to the “Services” tab and look for
a service named “Calc31Service” or “IQM Calculator Service […]”. The Status
column will show “Stopped” if the service is stopped, and “Running” if it is
running. To start, restart or stop, right-click the service and select the
corresponding command.

Calculation times with CalcService which get longer over time or result in
observable delays in plans being imported may be due to a system memory
issue. This is more likely to occur where there is a high volume of plans. This issue
is being investigated and will be resolved in a future release. If issues are
observed, Support can assist by scheduling a nightly automatic restart to
mitigate this system behavior. Contact iRT Support for more information.

4.5.5 Reviewing Successfully Imported Fields and References in Review


To review plans and fields successfully imported into the IQM Database, which
will be available when field delivery starts, open the Review and select the
patient for which the treatment plan was planned. In the “Linac/Detector”
menu select each Linac/Detector entry in turn and review the list of treatment
records on the left-hand side:

IQM User Reference Manual (v1.35a SW-v1.8) 4-15


Figure 22 - Reviewing imported fields and references in Review

The list will show the plans identified by the date and time each was imported
by IQM, and all imported fields. For each field, Review shows the available
references. For example, if a field was successfully imported and calculated, the
list will look as in Figure 23 for Field 2 with Field ID “F08”: there will be one entry
starting with “REF C” flagged as the current baseline.

For more information about IQM Review, please consult chapter 5 Using IQM
Review.

4.6 Starting the IQM Monitor Application & Test of “Alarm”


Function
Log in to the IQM Workstation as an Active Directory user who is a member of
the IQMMONuserGroup, in order to have the permission to access the IQM
Database. Start the IQM Monitor application by double-clicking its icon, on the
desktop or in the taskbar.

Do not run other applications while IQM Monitor is running, including not as
minimized windows. Close any other applications before starting IQM Monitor.

The Monitor application will open and attempt to connect to the IQM Database,
referred to as “DataStorage”. This step involves authentication at the SQL Server
and database, running on the IQM Server, as well as loading the specific Linac
and detector characterization data (also referred to as machine and chamber
configuration data), which the IQM Workstation is configured to support.

IQM User Reference Manual (v1.35a SW-v1.8) 4-16


Figure 24 - Status message shows "Connecting to DataStorage…"

Once that step is completed, a dialog will invite the user to see and hear how
the system looks and sounds if a serious delivery deviation occurs, the ‘Clinical
Alarm’ test.

Figure 25 - IQM Monitor application at startup, with Startup Test of Clinical Alarm Function

Run the Clinical Alarm test by clicking the button “Start Test of Alarm Function.”

Figure 26 - Demonstration and test of Clinical Alarm function at Startup

IQM User Reference Manual (v1.35a SW-v1.8) 4-17


The Monitor application background turns red, an Alarm dialog appears, and
an audible alert should sound.

Figure 27 - Initial display of Monitor application


with red application background and Clinical Alarm Test dialog

If desired, click “Stop sound” to turn off the audible alert while you complete the
test:

Adjust the
speaker
settings

Turn off the


audible
alert
Figure 28 - Clinical Alarm test at startup.

Complete the test by performing one of the following steps.

• Confirm that the alarm can be heard by selecting “I can hear the alarm”
and selecting ‘Finish’.

IQM User Reference Manual (v1.35a SW-v1.8) 4-18


• Adjust the settings if the audible alert cannot be heard by clicking “Open
Internal Speaker Settings.” After adjusting the speaker settings, click “Play
Sound” in the lower left corner of the screen to confirm that the alert can
now be heard.

If you hear it, select “I can hear the alarm” and click ‘Finish’ to complete
the test.

If the audible alert still cannot be heard, check whether speaker


hardware is turned off, turned down, or disconnected.

• Choose to run Monitor without audible alerts by selecting “Ignore


(continue anyway.)” and click ‘Finish’ to end the test.

This choice is logged with the date and time. Click ‘Finish’ to close the Clinical
Alarm startup test.

Caution:
Clinical Alarms in IQM indicate that treatment should be
interrupted immediately, based on criteria set by the
responsible staff in your own department.
The audible alert is necessary to direct your attention to the IQM
system in case of a Clinical Alarm. Disabling or subverting the
audible alert may cause Clinical Alarms to be missed.

4.7 Confirming that IQM is Ready – Status Indicators in Software


When the IQM Monitor application has loaded, check the status indicator area
at the bottom left of the application window.

IQM User Reference Manual (v1.35a SW-v1.8) 4-19


Figure 29 - Status Indicator area, system ready to monitor treatments

When communication with the Linac control system and the IQM Detector
hardware is working, the Linac Communication Indicator field says “OK” and the
Detector Status indicator field says “Monitoring.”

Look for any orange status areas, which indicate system errors that will prevent
the IQM from monitoring treatments and require user interaction such as
connecting cables or updating a setting in the configuration file. Yellow status
areas indicate conditions that may become problems, such as momentary loss
of network connectivity with the Linac control interface from which the system
may recover without user interaction, or low battery level.

Figure 30 - Status indicator fields, here with Warning indicator for Air Pressure

See the table in section 4.8.9 for the labels, colors and significance of text shown
in the Status Indicator area.

IQM User Reference Manual (v1.35a SW-v1.8) 4-20


Note the Monitoring Mode and Monitoring Status line at the top of the Monitor
application. See Table 10 - Detector Communication Errors shown at Startup,
Potentially Self-correcting and Table 11 - Detector Configuration Errors shown at
Startup, Typically Requiring User Intervention in section 6.4.4 Configuration File
Error Codes (IQM Workstation Only) for details about communication and
configuration errors that may occur.

IQM User Reference Manual (v1.35a SW-v1.8) 4-21


4.8 Monitoring Treatments with the IQM System

4.8.1 Automatic Detector Startup and Field Data Loading


No user interaction is required for the IQM system to monitor beam delivery.

Caution:
The user should not disconnect the network cable between the
Linac control system and the IQM workstation while the IQM is
monitoring the treatment. Disconnecting the network cable will
cause the IQM system to stop monitoring the treatment. In some
cases, it may interfere with the communication between the
record & verify system and the Linac, which could require user
interaction.

When the Monitor application is started, it first activates and verifies


communication with the IQM Detector and the Linac. During this startup
sequence, the system is not immediately ready to start monitoring, and the
Monitoring Status line at the top of the Monitor application will be shaded yellow
and read “Starting system communication.”

Figure 31 - Monitoring Status line while communication is being established with detector and Linac

Note that this often happens very quickly and the “Starting system
communication” message may appear only momentarily or not at all.
When communication has been successfully established, the IQM Monitor
software automatically starts receiving signal and angle measurements
(“polling”). The Monitoring Mode and Status line (also referred to as the
“Monitoring Status” line) is shaded green and the Status reads “Waiting for field.”
Field delivery can begin.

Figure 32 - Monitoring Mode and Status Line when ready for delivery to start

IQM User Reference Manual (v1.35a SW-v1.8) 4-22


When a patient and field are loaded at the Linac control console, the Patient ID
and Field ID are broadcast over the Linac network interface. IQM receives the
broadcast and looks for the patient and field in the IQM Database. If the Field
ID broadcast by the Linac interface is found in the IQM Database, the Monitor
application loads and shows the patient, Linac and field being treated, and
populates the tables and graphs with the field’s segment numbers and their
expected signal counts (Calculated Signal or Measured Signal Reference).

A B C

D F

E G

Figure 33 - Monitoring screen while field is in progress in Verification Mode

Elements of the IQM Monitor application display:

A) Patient and Treatment Machine Identification Area


B) Field ID
C) Monitoring Mode and Status Area
D) Cumulative Signal Graph
E) Segment-by-Segment Signal Graph
F) Cumulative Segment Signal Table
G) Segment-by-Segment Signal Table
H) Delivery Details Group
I) Status Indicators Group

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4.8.2 Patient and Treatment Machine Identification Area
The Patient ID, Patient Name and Date of Birth are shown in a block at the top
left of the Monitor display, with the Linac name of the treatment machine being
monitored and the beam energy and fluence mode of the field, when one is
loaded at the linac console.

Figure 34 -– Patient and treatment machine identification area

If the treatment plan for the loaded field is available, the Patient ID, Name and
Date of Birth and the nominal field energy from the plan will be shown (otherwise
“n/a” will be stated). If the fluence mode for the planned energy is flattening
filter free (FFF) the Field Energy is expressed as 6 MV FFF.

Verify that the correct patient has been detected by the IQM System by
comparing the Linac control console with the IQM Monitor display.

4.8.3 Monitoring Mode and Status Area

Figure 35 - Monitoring Mode and Status Area

The left panel indicates the Field ID (also referred to as “beam name”) last
broadcast by the Linac control system.

The top panel updates the Monitoring Status:

• Startup – As described in the startup section, messages here indicate


when the system is starting (“Starting system communication”) and when
it is ready to begin monitoring (“Waiting for field”).
• Field Delivery – reads “Field in progress” as signal measurements are
collected, indicates an Action or Watch level deviation if one occurs, and
reports the result of field delivery and issues encountered when

IQM User Reference Manual (v1.35a SW-v1.8) 4-24


measurements conclude. These messages remain on screen until the next
patient or field is loaded.
• System Errors and Alerts – if monitoring is not possible due to a system issue,
the specific issue is indicated here. More detailed information will be
presented in a dialog.

During normal operation, the Monitoring Status will read “Field in progress”
throughout field delivery.

When the Monitoring Mode is “Verification” the right panel in the second row
indicates whether the current delivery is being verified against a Measured
Reference or Calculated Reference and the date and time stamp of the
reference.

4.8.4 Segment-by-Segment and Cumulative Signal Graphs


As the treatment progresses, the signal counts for each segment are plotted on
two graphs, Segment-by-Segment and Cumulative.

The top Cumulative graph plots the sum of all signal counts measured since the
field began, accumulated as each segment completes. The plots in the
Cumulative graph always rise.

Figure 36 - Cumulative representation of the tolerance corridors derived from a reference of an


IMRT field

The bottom Segment-by-Segment graph plots the signal counts measured for
each segment. It rises and falls with the MU and spatially sensitive dose-area
product delivered in each segment.

IQM User Reference Manual (v1.35a SW-v1.8) 4-25


Figure 37 - Segment-by-Segment representation of the tolerance corridors derived from a
reference signal of an IMRT Field.

In each graph, segments that are not delivered as expected are shaded:

• Action-level deviations are shaded red.


• Watch-level deviations are shaded yellow.
• Non-delivered segments are shaded grey.
• Partially delivered segments are shaded light grey.

Figure 38 – Cumulative graph showing Segment #5 with a Watch-level deviation, partially


delivered Segment #7 and not-delivered Segments #9-21

IQM User Reference Manual (v1.35a SW-v1.8) 4-26


4.8.5 Segment Tables
As the treatment progresses, the measured signal counts for each segment are
added to the Cumulative and Segment-by-Segment Signal Tables.

With a row for each segment, the tables show the expected signal counts
(“Reference”) and the measured signal counts (“Measured”). In Verification
mode, with expected signal count values available, the deviations between
expected and measured are shown, both in absolute signal counts and as a
percentage.

Figure 39 - Segment Table

The segment last evaluated is shaded blue.

Segments that are not delivered as expected are also shaded:

• Action-level deviations are shaded red.


• Watch-level deviations are shaded yellow.
• Un-delivered segments are shaded grey.
• Partially delivered segments are shaded light grey.

4.8.6 Segment Group Display in Graphs and Segment Tables


When two or more segments are grouped together, whether due to mandatory
or elective merging, one data point represents the entire group.

In the graphs, the group data point is shown as a larger circle in the middle of
the grouped segment span. In the segment table, the group is shown in one row
with a dash separating the first and last segments in the group span (like
segments 12-14 in the example above.)

IQM User Reference Manual (v1.35a SW-v1.8) 4-27


4.8.7 Segment Presentation for Segments with No Signal Value
When one or more segments in a non-VMAT field do not have any segment
signal, as in move-only segments within Dynamic IMRT fields, no data point is
shown in MON, although the segment tick is still shown below the graph for
clarity. VMAT segments without signal are merged with neighboring segments
and become a segment group.

If a watch or action event occurs in a segment next to a move-only/no-signal


segment, the neighbor segment will be shaded but not the segment without
signal. Segments with no expected signal are not listed in the segment table. This
means that the graphs may show un-shaded segments that do not appear in
the table.

Figure 40 - Monitor display for a dynamic IMRT field with move-only segments. Every segment is
shown in the graphs, but only segments with signal are listed in the table.

IQM User Reference Manual (v1.35a SW-v1.8) 4-28


4.8.8 Delivery Details Group
The Delivery Details area is context sensitive, with four possible displays.

The area is populated when a new field is broadcast (“moded up”).

Mode Linac interface / Field Display in side bar


type

Verification Elekta: all techniques Planned Geometry


(plan & reference) (beam’s eye view)
Varian: RapidArc

Record Elekta: all techniques Planned Geometry


(plan, no reference) (beam’s eye view)
Varian: RapidArc

Verification Varian: static/IMRT (non- Progress Bar, labeled


(plan & reference) RapidArc) “Current Cumulative
(near-realtime) Signal vs. Reference”

Display Elekta: all techniques Blank


(no plan)

Record Varian: static/IMRT (non- Circle (Ring Spinner)


(plan, no reference) RapidArc)
(near-realtime)

Display Varian: all techniques Circle (Ring Spinner)


(no plan)

4.8.8.1 Planned Geometry


The Planned Geometry group displays information from the treatment plan
about the segment last evaluated by IQM, which is usually one segment previous
to the segment currently broadcast over the Linac interface.

IQM User Reference Manual (v1.35a SW-v1.8) 4-29


The Planned Geometry area displays the following information:

• Field ID
• Segment Number
• Field shape (beam’s eye view graphic)
• Gantry angle display in arc degree [°] - both planned and measured
angles are shown
• Collimator angle display in arc degree [°]

Figure 41 - Segment shape and gantry orientation (as per the treatment plan)

Note: The IQM Monitor application always displays information about the gantry
angle and the collimator rotation using the IEC 61217 coordinate system. This
may mean that the presentation of the beam aperture in IQM may not be the
same as the presentation in other applications, such as the view presented by
the record and verify system or the treatment planning system if these present
the view in a different native format. For example, MOSAIQ and Elekta consoles
may present in the Elekta native coordinate system, also referred to as the
bipolar coordinate system. The labelling of collimator jaws and leaves will be
different in this case.

The jaw and leaf positions presented in the Planned Geometry group are based
on the treatment plan and known adjustments applied by the linear accelerator
and the corresponding record and verify system (“as treated” configuration
versus “as planned” based only on the treatment plan). The Planned Geometry
display should match the display in the record and verify system.

The user should familiarize themselves with the display in IQM Monitor to ensure
that the display is being correctly interpreted, and any differences to the display
presented by other systems is understood.

IQM User Reference Manual (v1.35a SW-v1.8) 4-30


4.8.8.2 Progress Bar
For Varian IMRT fields monitored in Verification Mode, where no segment data
are available in realtime (during field delivery), a Progress Bar labeled “Current
Cumulative Signal vs. Reference” shows the total expected cumulative signal for
the field (as 100% indicator) and tracks the accumulated signal as the delivery
progresses (as a bar which is filling up). The planned collimator angles and
measured gantry angles are shown beneath this Progress Bar:

Figure 42 – Progress Bar presenting preliminary results for Varian IMRT fields in Verification Mode

For Varian IMRT fields, a conclusive evaluation of the segment-level results for a
monitored field can only be made after log file data has been received from
the Linac. While no per segment data is available in realtime, IQM tracks the
cumulative signal measured for the field as delivery progresses and evaluates it
against the total expected signal.

The Progress Bar provides an early indication of whether treatment delivery is


progressing as expected.

Significant overshooting of the planned cumulative dose can be detected and


results in a Clinical Alarm so that the user can investigate. E.g. in Figure 42, if the
cumulative signal value exceeds 120% of the expected total, a Clinical Alarm
dialog would be presented with information about the affected field and
deviation, accompanied by the familiar red frames and alarm tone. Once field
delivery is complete, the graphs and tables are populated and the conclusive
outcome indicated in the Monitoring Status Line.

IQM User Reference Manual (v1.35a SW-v1.8) 4-31


Significant undershooting can likewise be detected but is presented in a slightly
different way. Once the beam has stopped (Monitoring Status indicates “waiting
for segment data”), if the cumulative percent signal value stays below the lower
action level (e.g. in Figure 42 value stays below 80%) the Progress Bar is colored
red, but no Clinical Alarm is presented until the log file has been received from
the Linac. When the log file has been analyzed, the undershooting can be
correctly interpreted as either a partial field delivery or as a Clinical Alarm, and
presented accordingly.

More information about the Progress Bar is found in Section 4.14.1 “Progress Bar”

4.8.8.3 Ring Spinner


For Varian monitoring sessions in Display mode (all treatment techniques), and
for non-RapidArc fields in Record mode (i.e. IMRT or static), a rotating circle
labeled “Signal Acquisition” indicates when significant IQM signal is being
measured, indicating beam delivery in progress.

Figure 43 - Ring Spinner indicating Beam On time for Display Mode and Varian ADI/IMRT fields in
Record Mode

The signal acquisition circle will appear when the field is loaded to show that the
system is functioning. When the field ends, the rotating circle disappears.

IQM User Reference Manual (v1.35a SW-v1.8) 4-32


4.8.9 System Status Indicators
As described in section 4.7, the bottom left Status Indicator fields continually
update with the status of key system components.

Figure 44 - Status indicator area with Dose Output Correction and Background Signal Correction
enabled

When a system component is working fine, it appears grey.

Status Indicator fields which are shaded yellow indicate conditions that may
become problems, such as momentary loss of network connectivity with the
Linac control interface, or low battery level (System Warnings).

Orange status indicator fields indicate system issues that will prevent the IQM
from monitoring treatments and usually require user interaction (System Errors).

When a status indicator enters the warning or error state, a “ding” tone sounds
to attract attention to the IQM Monitor screen. Some warnings or errors are
accompanied by a dialog box to provide more detailed information.

The table below presents the labels, colors and significance of status labels
shown in the Status Indicator area.

Table 2 - Status Indicator Fields

Field Label/Appearance Description


Linac OK Communication with linear
Communication accelerator (iCom/ADI/…) established
Communication Communication with the Linac
Error interface was established but has been
(yellow background) temporarily interrupted. This type of
communication error often clears itself.

IQM User Reference Manual (v1.35a SW-v1.8) 4-33


Field Label/Appearance Description
Configuration Error The Monitor application cannot initiate
(orange communication with the Linac. (Such
background) as when cable or device is defective.)
This error will not clear itself and must
be resolved before the application will
work.
IQM Detector n/a At startup, communication has not yet
been established with the detector,
and no error has been encountered.
Starting system The IQM Detector is initiating polling
communication (This happens very fast, and this
message might not be seen.)
Monitoring The IQM Detector is actively polling, i.e.
the software is receiving data from the
detector.
Communication Communication with the IQM detector
Error is momentarily unavailable. This
(yellow background) problem may clear itself.
Configuration Error The Monitor application is unable to
(orange communicate with the IQM Detector
background) due to a permanent issue, such as that
required software libraries are missing,
or COM port already used.
DOC Factor 1.0NNN (Value from Dose Output Correction (DOC) factor
database) has been set in the database and is
being applied to measured segment
signals for evaluation and display.
See appendix A5.
n/a No DOC factor has been set
Background NNNN When enabled, background signal for
Signal which measured signal values are
corrected (expressed in polls/second).
See section 6.2.5.
NNNN Background signal value is not within
(yellow background) expected range
Air Pressure Current values from See following section 4.8.10.
detector sensor
n/a No communication with detector or no
pressure sensor information is available.

IQM User Reference Manual (v1.35a SW-v1.8) 4-34


Field Label/Appearance Description
Temperature Current values from See following section 4.8.10.
detector sensor
n/a No communication with detector or no
temperature sensor information is
available.
Battery HH:MM hours Remaining battery charge is above or
equal to 2 hours.
HH:MM hours Remaining battery charge is less than 2
(yellow background) hours but more than 30 minutes.
HH:MM hours Remaining battery charge is less than
(yellow flashing 30 minutes but more than 15 minutes.
background)
HH:MM hours Less than 15 minutes of battery power
(orange (in “beam on” mode) remain.
background)
n/a No communication with detector or no
battery information is available.

4.8.10 Environmental Condition Indicators


The Air Pressure and Temperature status fields show the current barometric
pressure by default in millimeter of mercury (mmHg) and temperature in degrees
Celsius (˚C). The displayed unit for air pressure can be set to kilo pascal (kPa) or
hector pascal (hPa) instead (see section 6.4.1.3.3) and will typically be set by
installation staff when the system is installed, as desired by the designated
responsible user.

The current air pressure and temperature values measured at start of a field are
used to correct the raw signal values received from the electrometer, so both
values are measured when the detector is switched on and with each poll. If the
values are in a predefined valid range, they are used to correct the raw signal,
so that signal measured at different times remains comparable.

Figure 45 Current air pressure within expected range, shown at right

Figure 46 - Current temperature within expected range, shown at right

IQM User Reference Manual (v1.35a SW-v1.8) 4-35


The expected range for air pressure and temperature values at the
department’s location is displayed at the far right of the respective indicator
field. If the environmental readings go out of these ranges, the indicator field
turns yellow, but IQM continues to monitor the treatment, using the last valid
values before they went out of range.

Figure 47 - Air pressure status label where the pressure reading


is outside the expected range

If no valid (in-range) temperature or air pressure values have been received from
the electrometer since IQM Monitor was started, the software will use default
values to correct the signal counts (760 mmHg for air pressure, 22.0° C for
temperature).

In addition to shading the detector status indicator field yellow in realtime if the
temperature or pressure goes out of range, at the beginning of each field IQM
checks the temperature and pressure against the valid range. If this “Field start”
reading is out of range, a system warning message is shown in the Monitoring
Status line at the end of the field:

Figure 48 - Monitoring Status line with air pressure caution message.

Figure 49 - Monitoring Status line with temperature caution message.

This system warning message at the end of the field is intended to highlight the
high probability that any deviations seen in the field could likely have been
caused by the unexpected environmental readings.

Because this end-of-field message is based on the check of environmental


conditions at ‘Field Start,’ the realtime indicators can be out of sync with the
end-of-field message, if the temperature or pressure changes significantly during
the field delivery. This is an unlikely occurrence, as temperature and pressure in
the treatment room typically change slowly.

The expected air pressure and temperature ranges at the user’s location will be
assessed during installation and taken into consideration during system setup
and configuration.

IQM User Reference Manual (v1.35a SW-v1.8) 4-36


The temperature and air pressure can significantly impact the results of raw
signal count correction as displayed in IQM Monitor data graphs and tables, and
an incorrect air pressure reading in particular may cause significant deviations
in the signal to be reported although the treatment delivery is progressing as
expected and within the defined tolerances. Therefore, anytime Watch level
deviations or a Clinical Alarm occur and the Air Pressure or Temperature field
label is shaded yellow, investigate the air pressure and temperature sensors as a
likely cause for the deviation by comparing it to an independent measuring
device.

Note that it is far more likely that a temperature or air pressure system error is
caused by the failure of these detector sensors than that environmental
conditions in the treatment room are really exceeding the expected range. Air
pressure or temperature values outside the expected range may indicate a
technical problem with the detector sensors and may lead to unreliable
measurement results. If the user observes that these indicator fields are
frequently turning yellow or remain yellow, contact iRT Support to determine if a
technical problem with a sensor has occurred.

4.9 When Field Delivery or IQM Monitoring Ends


The IQM system is designed to operate continuously throughout the treatment
day, without user interaction. Because field delivery is routinely interrupted to
accommodate patient or equipment issues, IQM also recognizes and responds
to paused and interrupted fields.

This section describes what happens

• when the field is completed (delivered and monitored),


• when field delivery is paused, and resumed within the same treatment
session,
• when field delivery is interrupted and the treatment session ends,
• when field monitoring stops due to an IQM System Error,
• when field delivery stops unexpectedly due to a Linac system issue.

4.9.1 When the Field Delivery is Completed


When the field delivery is finished at the Linac console, the Status Line shows that
field delivery has completed and the results of verification, if applicable, e.g.
“delivered as expected”.

When a new patient and field are loaded at the Linac console, IQM
automatically loads the new patient and field and monitors the treatment.

IQM User Reference Manual (v1.35a SW-v1.8) 4-37


4.9.1.1 Unacknowledged Alarms Persist through New Fields and Patients
If a Clinical Alarm for a previous patient has not yet been acknowledged, it
remains onscreen through subsequent field deliveries, but no user action is
required for IQM to continue monitoring.

In this case, the application background will no longer be red, and no segments
are shaded red in the graphs or Segment Table, but the dialog remains. To
indicate to which patient and field the Clinical Alarm belonged, the Patient ID
and Field ID are shown in the Clinical Alarm dialog.

Patient ID
Field ID

Figure 50 Clinical Alarm message for a Serious Deviation, before acknowledgement

4.9.2 When Field Delivery is Paused and Resumes without Termination


Sometimes field delivery is paused, i.e. stopped momentarily mid-field, but is then
resumed without ending the treatment at the Linac console, such as when a
patient shifts position and needs to be re-positioned, or if a Linac interlock occurs
but is quickly cleared.

IQM continues to wait for additional data for the current field until it receives the
FieldEnd event, so it will continue monitoring as soon as the Linac continues
delivering the field. The beam pause is not indicated in the IQM Monitor
application.

4.9.3 When Field Delivery is Interrupted and the Treatment Session Ends
Sometimes field delivery is stopped mid-field and the current delivery session
ends, such as when a patient feels nauseated or if the Linac has a service issue.
In this case the user stops (terminates) delivery at the control console, which ends
the monitoring session for the field (FieldEnd event) with the information, how
much dose was delivered so far (“MU Delivered”).

IQM User Reference Manual (v1.35a SW-v1.8) 4-38


If the “Mu Delivered” value received by IQM is less than the total MU for the field
as per the treatment plan, IQM recognizes the delivery as a partial field. The
Monitor status line indicates that the field was only partially delivered, and the
onscreen graphs reflect whether each segment was completely delivered (data
point and white background shading), partially delivered (no data point and
light gray shading) or not delivered (no data point and gray shading).

Figure 51 - Field partially delivered when treatment session ended

4.9.3.1 Inconsistent Partial Field Error


When IQM receives a “Field End” event from the Linac console with an “MU
Delivered” value less than the total Field MU from the treatment plan, and
identifies the delivery as a partial field, it uses the “MU Delivered” value to
calculate which segment corresponds to the quantity of MU delivered so far.

If the Linac’s last delivered segment was a different segment (identified by


segment number, for static/IMRT, and by gantry angle, for VMAT) IQM issues an
“Inconsistent Partial Field Error” (or possibly “Gantry Angle Alarm” for VMAT).

4.9.3.2 Detecting Deliveries of a Continued Partial Field


If a portion of a field has already been delivered in a previous session, and the
Linac control console loads the remainder of the field, the IQM software receives
the “Field Start” event with an “MU to be Delivered” value that is less than the
total MU for the field as per the treatment plan.

IQM User Reference Manual (v1.35a SW-v1.8) 4-39


IQM recognizes this situation as the continuation of a partial field and uses the
“MU to be Delivered” value to identify in which segment the continued beam
will begin. In Verification mode, it presents the skipped (previously delivered)
segments at the beginning of the field in gray and calculates the expected
cumulative signal value through the immediately preceding segment from the
reference data, so that the cumulative graph can still be meaningfully
populated. During field delivery, the Monitoring Status line states “In Progress –
Caution: Anticipating completion of a partial field based on broadcast MU ([mu-
planned-as-per-linac] instead of Planned MU [mu-as-per-plan])”, shaded yellow.

Figure 52 - Continuation of a field that was partially delivered in a previous treatment session.
Segments not delivered in this session are shaded dark grey, segments partially delivered in this
session are shaded light grey, but no data point is shown for them.

4.9.4 When Field Monitoring Stops due to an IQM System Error


When IQM is monitoring and stops due to an IQM System Error, e.g. a Field Error
which prevents monitoring from continuing, such as if the MU values per linac
broadcast and per the treatment plan do not match, the Status Line is shaded
orange and a dialog appears explaining the error that occurred. A text message
in the monitoring status line also shows the error title.

When a Field Error occurs (message code starts with “FieldError”), the segment
signal values measured up until the segment in which the error occurred are

IQM User Reference Manual (v1.35a SW-v1.8) 4-40


stored as a partial treatment record. The segment in which the error occurred
and any remaining segments after the error are not stored in the IQM Database.
For more information about Field Errors refer to section 4.11.

As soon as a new field or plan is loaded at the Linac console, IQM will attempt
to resume monitoring automatically. However, for System Errors, it may be
necessary to exit and reopen IQM Monitor, typically after investigating and
resolving the source of the error (such as a configuration error where settings in
the IQM.Config.ini file need to be corrected.)

4.9.5 When Field Delivery is Terminated Unexpectedly


Although modern linear accelerators and treatment rooms are often equipped
with backup batteries, generators and redundant systems, it is conceivable that
the Linac stops a field delivery unexpectedly, in an abrupt, “untidy” manner, and
does not continue to broadcast events such as when the field ends. This might
happen if the Linac control console failed, or if it lost connectivity to the Linac or
to the broadcast system.

Because IQM cannot know the MU delivered so far, the segment evaluated
while delivery stopped unexpectedly may be presented as “not delivered” (no
data point and gray shading) although it was delivered.

4.10 Clinical Alarms during Treatment Delivery

Caution:
By definition, Clinical Alarms in IQM Monitor indicate that
treatment should be interrupted immediately and the cause of
the deviation investigated.
Clinical Alarms in IQM Monitor typically occur when the
difference between the planned and delivered treatment
exceeds a limit set by the responsible staff in your own
department.

In Verification mode, if the responsible designated user has configured Watch


and/or Action level deviation limits, and the measured signal counts deviate
beyond those limits, a ‘Clinical Alarm’ warning will be shown.

If a Clinical Alarm condition occurs, the background of the screen is shaded red,
an audible alert sounds, and a Clinical Alarm dialog appears. In case of signal
deviations, the segment in which the alarm condition occurred is shaded red in
the graph and table where the segment criteria were exceeded.

IQM User Reference Manual (v1.35a SW-v1.8) 4-41


Figure 53 - Monitor application with an Alarm condition

The dialog provides information about the Clinical Alarm condition and allows
the user to turn off the audible alert by touching the [Stop Sound] button in the
dialog box or acknowledge and close the alarm dialog by touching the
[Acknowledge Alarm] button.

Alarm
title

Alarm
details

“Skip”
checkbox
“Acknowledge”
“Mute” button
button

Figure 54 Dialog presentation of a Clinical Alarm (detailed view)

The Clinical Alarm dialog box details include in which segment the alarm
condition occurred. The Patient ID and Field ID are included for clarity in case
the Clinical Alarm is not acknowledged before the next treatment begins.

IQM User Reference Manual (v1.35a SW-v1.8) 4-42


Caution:
The IQM System continues monitoring through Clinical Alarm
conditions whenever possible and will automatically begin
monitoring when and if a new field is broadcast at the linear
accelerator. The Clinical Alarm dialog(s) remain onscreen until
acknowledged.
If a Clinical Alarm dialog is onscreen but the Monitor application
display is not shaded red, check the Patient and Field IDs. The
Alarm was most likely for a previous field.

The “Stop Sound” button allows the audible alert to be turned off, to minimize
the stress conditions in the Linac control room while the user reads and responds
to the Clinical Alarm message.

The checkbox “Skip this message for additional action-level signal deviations in
this field” prevents IQM from showing the same alarm message in additional
segments. This is intended to allow the user to focus on the errors being shown
onscreen, rather than being distracted by messages popping up and covering
the relevant portions of the screen.

However, even if this checkbox is marked, OTHER alarm conditions will still prompt
a Clinical Alarm dialog if they occur.

The Acknowledge button “clears” the warning. The Clinical Alarm condition,
and the time and date the Clinical Alarm occurred will be recorded in the IQM
Database.

When the Clinical Alarm is acknowledged, the audible alert stops (if not already
turned off) and the Monitor application background returns to gray, except for
the Monitoring Status line at the top of the application which remains red and
displays the Alarm condition that occurred.

When an action-level signal deviation occurs, the segment’s background area


in the graph remains shaded red.

IQM User Reference Manual (v1.35a SW-v1.8) 4-43


Figure 55 – Segment graph after Clinical Alarm, shows watch-level deviation in yellow and
action-level deviation in red

The segment row in the respective table is also shaded red.

Figure 56 - Segment Table after Clinical Alarm, shows Watch level and
Action level deviations

Table 3 lists the conditions that prompt Clinical Alarms and indicates for each
whether the alarm condition automatically terminates monitoring or if
monitoring continues.

Further information about the specific alarm situation is provided in the dialog
box which accompanies the alarm. If possible, it also includes hints for
investigation of the problem.

The patient ID and further alarm-specific details are included in the dialog box
as applicable. They are omitted in the following table.

IQM User Reference Manual (v1.35a SW-v1.8) 4-44


Table 3 - Conditions for Clinical Alarms – Signal Deviations

Alarm Dialog Message Alarm Condition


Warning: Action-Level Signal Deviation (Cumulative) Signal deviation exceeds
Pause and Investigate Treatment! Action level criteria
a) in the Cumulative
Patient ID: [patient-id] evaluation

The measured cumulative IQM signal for Segment(s) Monitoring continues


[segment-id(s)] is in the action range.

Measured signal: X

Signal deviation: Y%
Applied action level: +/- Z %

Treatment should be paused and the cause of the


deviation investigated.

Message Code: FieldCumulativeDeviationAlarm.Realtime


Warning: Action-Level Segment Signal Deviation Signal deviation exceeds
Pause and Investigate Treatment! Action level criteria
b) in the Segment-by-
Patient ID: [patient-id] Segment evaluation

The measured IQM signal for Segment(s) [segment-id] is in Monitoring continues


the action range.

Measured signal: X

Signal deviation: Y%
Action level: +/- Z %

Treatment should be paused and the cause of the


deviation investigated.

Message Code:
FieldPerSegmentDeviationAlarm.Realtime

IQM User Reference Manual (v1.35a SW-v1.8) 4-45


Table 4 Conditions for Clinical Alarms – Signal Deviations (Varian Static/IMRT
fields only)

Alarm Dialog Message Alarm Condition


Warning: Action-Level Segment Signal Deviation in a Varian Static/IMRT fields
Delivered Field only:
Segment signal was in
Patient ID: [patient-id] Action range for field just
concluded.
The measured IQM signal for Segment(s) [segment-id(s)]
was in the action range. Monitoring continues
The cause of the deviation should be investigated.

Message Code:
FieldPerSegmentDeviationAlarm.Concluded
Warning: Action-Level Signal Deviation (Cumulative) Varian Static/IMRT fields
Pause and Investigate Treatment! only:
Cumulative signal
Patient ID: [patient-id] delivered so far, while
beam is in progress, is in
The measured cumulative IQM signal for Field [field-id] is Action range compared
in the action range for the total field. to the total expected
exceeds the expected signal by more than the cumulative signal for the
cumulative action level specified for the end of the field.
field.
Measured signal: X Monitoring continues

Signal deviation: Y%
Applied action level: +/- Z %

Treatment should be paused and the cause of the


deviation investigated.

Message Code:
FieldCumulativeDeviationAlarm.InProgress
Warning: Action-Level Signal Deviation (Cumulative) Varian Static/IMRT fields
In a Delivered Field only: Cumulative signal
was in Action range for
Patient ID: [patient-id] field just concluded.

The measured cumulative IQM signal for Field [field-id], Monitoring continues
Segment(s) [segment-id(s)], was in the action range.

The cause of the deviation should be investigated.

Message Code:
FieldCumulativeDeviationAlarm.Concluded

IQM User Reference Manual (v1.35a SW-v1.8) 4-46


Table 5 Other Conditions for Clinical Alarms

Alarm Dialog Message Alarm Condition


Warning: Gantry Angle Deviation Static/IMRT fields only:
Pause and Investigate Treatment! Gantry Angle does not
match that in the
Patient ID: [patient-id] treatment plan.

a) [Detected gantry angle for Segment [segment-id] Monitoring stops


does not match the planned gantry angle from the
treatment plan within the specified tolerance
("GantryError").] or b) [A gantry angle detected within the
field does not match the planned gantry angle from the
treatment plan within the specified tolerance (parameter
SystemLimits.GantryError).]

Detected gantry angle: Y°

Treatment should be paused and the cause of the


deviation investigated.

Message Code: FieldErrorGantryAngle


Warning: Wrong Gantry Rotation Direction GantryDirection (field
Pause and Investigate Treatment! error) – Gantry motion
(while beam is on) was
Patient ID: [patient-id] detected in the wrong
direction.
Detected gantry rotation in the wrong direction while
beam delivery was in progress. The problem was Monitoring stops
detected at the following position:

Gantry angle: Y°

Treatment should be paused and the cause of the


deviation investigated.

Message Code: FieldErrorGantryDirection

IQM User Reference Manual (v1.35a SW-v1.8) 4-47


Alarm Dialog Message Alarm Condition
Warning: Unknown Segment Number Static/IMRT fields only:
Pause and Investigate Treatment! UnknownSegment (field
error) – A segment
Patient ID: [patient-id] (actually, a control
point) number was
Segment [segment-id] was broadcast by the Linac but is broadcast by the Linac
not specified in the treatment plan. that does not exist in the
Treatment should be paused and the cause of the treatment plan for the
deviation investigated. field (as imported to
IQM).
Check whether the treatment plan loaded by IQM
Monitor corresponds to the plan loaded by the Linac Monitoring stops
record & verify system.

Message Code: FieldErrorUnknownSegment


Warning: Beam Energy Deviation VMAT and Elekta IMRT
Pause and Investigate Treatment! non-VMAT fields only:
The energy reported in a
Patient ID: [patient-id] SegmentStart event is
not the same as defined
The energy (beam energy and fluence mode) reported in the plan.
by the linear accelerator does not match the energy
specified in the treatment plan. Monitoring continues

Energy reported by linear accelerator: X ["FFF" |


"(standard)"]
Energy as per treatment plan: X ["FFF" |
"(standard)"]

Treatment should be paused and the cause of the


deviation investigated.

Message Code: BeamEnergyAlarm.Realtime

Note: IQM evaluates each segment as it is completed; for IMRT this means when
the segment end message is received, for VMAT, when the gantry exits the angle
span of the delivered segment and enters the next one. This means that if a Linac
fault occurred where the gantry stopped rotating during a VMAT segment, IQM
may not detect this deviation, because the segment is not evaluated until it is
completed.

IQM User Reference Manual (v1.35a SW-v1.8) 4-48


Caution:
IQM can only detect inter-segment errors, not intra-segment
errors. IQM can only detect errors in completed segments, not
in segments still in progress.
A Linac fault which occurs in a segment that is never completed
might not be detected and reported by IQM because IQM can
evaluate the segment only once it has been completed.

4.11 Field Errors During Field Delivery


Certain events that do not necessarily indicate serious treatment failure
nevertheless prevent the IQM from evaluating the treatment. In this case, IQM
communicates a Field Error in form of a System Error message, indicating that
something unexpected has occurred or been detected which IQM cannot
evaluate or which prevents IQM from evaluating the field. Therefore, when a
Field Error occurs, monitoring will generally stop for that field.

Note: Acknowledge the dialog by touching the [OK] button.

IQM indicates Field Errors with a System Error dialog and by shading the
Monitoring Status area orange with the text “Caution: Monitoring terminated
due to System Error ([Message Code])”. The message code which uniquely
identifies the error is displayed both in the Monitoring Status line as well as in the
dialog box as shown in the following figure.

IQM User Reference Manual (v1.35a SW-v1.8) 4-49


Figure 57 - Example for a Field Error presented as a System Error

IQM will attempt to recover automatically from System Errors and Field Errors.
When a new patient and field are loaded at the Linac console, the Field Error
will clear itself and IQM automatically loads the new patient and field and
monitors the treatment.

Other examples for Field Errors include the Linac broadcasting an unexpected
segment, (one that is repeated, FieldErrorRepeatedSegment, or out of order,
FieldErrorOutOfOrderSegment) or the IQM detecting signal when according to
the Linac broadcast no beam is being delivered (“Unexpected Signal” errors:
signal before first segment, FieldErrorPreSignal or between segments,
FieldErrorInterSignal, or signal after the last segment, FieldErrorPostSignal).

If signal is detected when no radiation is being delivered, there may be a timing


or configuration issue that might be resolved by reviewing the software
configuration. Otherwise, there may be a hardware fault in the detector or there
could be something unexpected in the equipment setup or in the treatment
delivery. For example, if one of the above-mentioned “Unexpected Signal” field
error is presented, the IQM plan version may be out of date, that is, a different /
newer version of the plan was delivered at the accelerator than IQM has
received. However, in both situations, the IQM is unable to provide its intended

IQM User Reference Manual (v1.35a SW-v1.8) 4-50


use of verifying the delivery signal against an expected signal, so monitoring
stops and a Field Error is shown.

Figure 58 – Monitoring status showing a Field Error

Because issues resulting in a Field Error could also possibly indicate a problem
with the treatment delivery, users are strongly urged to pause treatment and to
investigate. It is recommended to confirm that the right treatment plan has been
imported to the IQM database and/or loaded at the Linac control console, and
to consult a responsible medical physicist about the linear accelerator behavior.
Possible Field Errors are listed in Table 6, below.

Note: The Field Error dialog boxes include more details than summarized in the
table, e.g. patient ID, and error-specific data such as segment number(s) where
a deviation occurred, or the amount of MU that was planned versus the amount
broadcast by the Linac. These details are not included in Table 6, below.

4.11.1 Signal-related Field Errors


Table 6 – Messages for Field Error Dialogs

Field Error Dialog Message Issue


Caution: Unexpected Signal before First Segment IQM signal for beam was
detected before the first
Patient ID: [patient-id]
segment was identified.
Detected beam signal before start of the first
segment.
Cannot perform monitoring Field [field-id].
Signal value before first segment: [poll signal]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorPreSignal

IQM User Reference Manual (v1.35a SW-v1.8) 4-51


Field Error Dialog Message Issue
Caution: Unexpected Signal between Segments IQM signal value for beam
was detected between two
Patient ID: [patient-id]
segments
Detected unexpected beam signal between
segments.
Cannot resume monitoring Field [field-id].

Segment numbers: [first segment number] – [second


segment number]
Signal value between segments: [poll signal]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorInterSignal

Caution: Unexpected Signal after Last Segment IQM signal for beam was
detected after the last
Patient ID: [patient-id]
segment
Unexpected beam signal after delivery of the last
segment. Monitoring results for Field [field-id] are
inconclusive.
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
cannot be solved, contact IQM Support.
Message Code: FieldErrorPostSignal

Caution: Early Beam Delivery IQM signal was detected as


soon as polling started. This
Patient ID: [patient-id]
usually means the field
Delivery of the beam seems to have started before delivery began before IQM
IQM started monitoring. Cannot perform monitoring Monitor Status was ready to
Field [field id]. measure beam.
First measured signal value: [poll signal]
Please check Linac behavior. If the problem persists,
contact IQM Support.
Message Code: FieldErrorEarlySignal

IQM User Reference Manual (v1.35a SW-v1.8) 4-52


Field Error Dialog Message Issue
Caution: Field in Sequence at Unexpected Gantry / Occurs on Varian linear
Collimator Location accelerators during AFS
Patient ID: [patient-id] sequence delivery when
significant signal is detected
Delivery in sequence began for a field at gantry at a gantry / collimator angle
angle [NNN.N°] and collimator angle [NNN.N°] but location where there is no
the treatment plan for broadcast field [field-id] does field in the same plan.
not include a field at [NNN.N°/NNN.N°] eligible for
delivery in a field sequence. Note: applicable for static-
angle fields (static, IMRT
Cannot continue monitoring field at gantry / StepNShoot or dynamic IMRT)
collimator angle [NNN.N°/NNN.N°]. on Varian linacs
Message Code: FieldErrorSequenceNoField

Caution: Field in Sequence at Unexpected Energy Occurs on Elekta linear


and Gantry / Collimator Location accelerators during AFS
Patient ID: [patient-id] sequence delivery when
significant signal is detected
Delivery in sequence began for a field with beam at an energy/fluence and
energy [iCOM Beam Energy] [iCOM Fluence Mode] gantry / collimator angle
at gantry angle [NNN.N°] and collimator angle location that does not match
[NNN.N°] but the treatment plan for broadcast field any field in the same plan.
[field-id] does not include a field at [
NNN.N°/NNN.N°] eligible for delivery in a field Note: applicable for static-
sequence. angle fields (static, IMRT
StepNShoot or dynamic IMRT)
Cannot continue monitoring field at gantry / on Elekta linacs
collimator angle [NNN.N°/NNN.N°].

Message Code: FieldErrorSequenceNoField

IQM User Reference Manual (v1.35a SW-v1.8) 4-53


4.11.2 Segment Data-related Field Errors
Field Error Dialog Message Issue
Caution: Unexpected Segment Data from Linac A segment was broadcast by
(Invalid Segment) the Linac control system with
segment number < 1. Applies
Patient ID: [patient-id]
only to non-VMAT fields.
Segment number broadcast by the Linac was
unexpected: segment number is less than one.
Cannot resume monitoring Field [field-id].
Segment number: [segment-number]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorInvalidSegment

Caution: Unexpected Segment Data from Linac A specific segment was


(Repeated Segment) broadcast by the Linac
control system twice.
Patient ID: [patient-id]
Segment number broadcast by the linac was
unexpected: segment number was already
broadcast. Cannot resume monitoring Field [field-id].
Segment number: [segment-number]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorRepeatedSegment

Caution: Unexpected Segment Data from Linac (Out One or more segments were
of Order) received in the wrong order.
For non-VMAT treatments
Patient ID: [patient-id]
only.
Segment number broadcast by the linac was
unexpected: segment number is less than the
segment number of the previous segment. Cannot
resume monitoring Field [field-id].
Current segment number: [segment-number]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorOutOfOrderSegment

IQM User Reference Manual (v1.35a SW-v1.8) 4-54


Field Error Dialog Message Issue
Elekta linear accelerators only: The number of missed
segments, i.e. segments that
Caution: Missing Segment Data from Linac
were not broadcast by the
Patient ID: [patient-id] Linac, is higher than the
defined limit
Too many segments were not broadcast by the linac,
MaxUnrepSegments. For
starting with segment number [segment-number].
Elekta non-VMAT treatments
Cannot resume monitoring Field [field-id]. only.
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorMissingSegment

4.11.3 MU-related Field Errors


Field Error Dialog Message Issue
Caution: Invalid Planned MU Value Reported with Field The MU value to be delivered,
included with the Field Start
Patient ID: [patient-id]
broadcast event, is larger
The MU value to be delivered for this field, as than the total MU for the field
broadcast by the linac record & verify system, is larger specified in the treatment
than the MU for the field as specified in the treatment plan.
plan. This Field Error occurs only for
VMAT treatments.
Target MU as broadcast by Linac: [MuPlanned]
MU from plan: [MuField]
Message Code: FieldErrorMuPlanned

Caution: Invalid Delivered MU Value Reported with The MU delivered for this field,
Field as broadcast with a Field End
or Segment End event, is
Patient ID: [patient-id]
higher than the total MU for
The MU delivered for this field, as broadcast by the the field specified in the
linac record & verify system, is larger than the planned treatment plan OR higher
MU for this field or the target MU value broadcast at than the MuPlanned value
start of field. broadcast at the field start.
MU from plan: [MuField]
Target MU as broadcast by Linac: [MuPlanned]
Delivered MU as broadcast by Linac: [MuDelivered]
Message Code: FieldErrorMuDelivered

IQM User Reference Manual (v1.35a SW-v1.8) 4-55


Field Error Dialog Message Issue
Caution: Unexpected Segment for Partial Field Occurs if field (as broadcast)
is a partial field but the
Patient ID: [patient-id]
Planned MU broadcast with
Segment number broadcast by the Linac for the last the Field End event is not
segment before interruption was unexpected for this appropriate (as expected) for
partial field. the last segment broadcast.
Last broadcast segment before interruption: [number
of last segment which had been broadcast when
the error was detected]
Last expected segment as per MU delivered Linac
broadcast: [segment number of last expected
segment based on MuDelivered]
This indicates a problem with the IQM System, or the
Linac. Please check Linac behavior. If the problem
persists, contact IQM Support.
Message Code: FieldErrorPartial

4.11.4 Communication-related Field Errors

Field Error Dialog Message Issue


Caution: Linac Communication Problem during Field Linac communication was
Delivery interrupted while actively
monitoring. While Linac
Patient ID: [patient-id]
communication may restore
Communication between the IQM software and the itself, the field cannot be
Linac record & verify system has been interrupted monitored because one or
during field delivery. Cannot resume monitoring Field more segment or other Linac
[field-id]. messages may have been
missed.
Please contact IQM Support.
Message Code: FieldErrorLinacComm.
[ Unknown | IOError]

IQM User Reference Manual (v1.35a SW-v1.8) 4-56


Field Error Dialog Message Issue
Caution: Linac Configuration Problem during Field Linac communication was
Delivery interrupted while actively
monitoring.
Patient ID: [patient-id]
Errors of this type are not likely
Communication between the IQM software and the to occur since they are
Linac record & verify system has been interrupted typically handled at startup of
during field delivery. Cannot resume monitoring Field the Monitor application.
[field-id]. The Message Code indicates
the underlying cause.
Please contact IQM Support.

Message Code: FieldErrorLinacPerm.


[ Unknown | InvalidConnectString |
MissingCommAssemblyName |
SpecifiedCommAssemblyName |
CannotLoadCommAssembly |
CannotLoadVendorDLLs | InvalidVendorDLLs |
CannotConnect | MachineNameConflict]

Caution: Detector Communication Problem during Communication between the


Field Delivery IQM software and the IQM
Detector has been
Patient ID: [patient-id]
interrupted during field
Communication between the IQM software and the delivery. There may be a
IQM Detector has been interrupted during field problem with the network
delivery. Cannot continue monitoring Field [field-id]. connection, or the detector
may not be online.
If this issue does not resolve itself, there may be a
problem with the network connection, or the detector
may not be online.
Message Code: FieldErrorSysconComm.
[ Unknown | IOError]
Caution: Inclinometer Problem during Field Delivery The IQM system received an
error code or unexpected
Patient ID: [patient-id]
data from the inclinometer
An inclinometer error was received from the IQM and cannot resume
Detector, or the detector was moved in an monitoring. The inclinometer
unexpected manner (angular velocity not within the determines gantry and
expected range). collimator angles and the
error indicates a problem with
Cannot resume monitoring Field [field-id].
the component.
If the problem persists, contact IQM Support.
Message Code:
FieldErrorSysconComm.InclinometerError

IQM User Reference Manual (v1.35a SW-v1.8) 4-57


Field Error Dialog Message Issue
Caution: Electrometer Problem during Field Delivery The IQM system received an
error code from the
Patient ID: [patient-id]
electrometer, i.e. the signal
An electrometer error was received from the IQM measurement electronics,
Detector. and cannot resume
monitoring. This error indicates
Cannot resume monitoring Field [field-id].
a problem with the
If the problem persists, contact IQM Support. electrometer.
Message Code:
FieldErrorSysconComm.ElectrometerError

Caution: Monitoring terminated due to Low Battery This error occurs if the battery
becomes too low to continue
Patient ID: [patient-id]
monitoring during field
The IQM Detector battery is too low to continue delivery.
monitoring. Monitoring of Field [field-id] terminated.
Recharge the detector before resuming monitoring.
Message Code:
FieldErrorSysconComm.LowBattery

Detector Configuration Problem during Field Delivery Communication between the


IQM software and the IQM
Patient ID: [patient-id]
Detector has been
Communication between the IQM software and the interrupted during field
IQM Detector has been interrupted during field delivery.
delivery. Cannot continue monitoring Field [field-id]. Errors of this type are not likely
to occur since they are
If this issue does not resolve itself, there may be a
typically handled at startup
problem with the network connection, or the detector
of the Monitor application.
may not be online.
The Message Code indicates
Message Code: FieldErrorSysconPerm.[ Unknown | the underlying cause.
InvalidConnectString | InvalidFirmwareVersion |
InvalidPort | PortAlreadyOpen | PortDoesNotExist |
WrongSystemSerialNumber]

IQM User Reference Manual (v1.35a SW-v1.8) 4-58


4.11.5 Communication-related Field Errors (Varian only)
Field Error Dialog Message Issue
Caution: Missing Linac Log File The trajectory log data for this
field arrived too long after the
Patient ID: [patient-id]
ADI broadcast of the Field
The Varian Linac log file did not become available End event, or the trajectory
within the expected time frame. log data never appeared. For
Varian treatments only.
Monitoring results cannot be evaluated for Field [field-
id].
A possible solution is to increase the /TT value (log-file-
timeout in milliseconds) of the LinacConnectString
parameter in the IQM.Config.ini file.

The designated responsible user should review the


settings. If the problem persists, contact IQM Support.
Message Code:
FieldErrorLinacData.NoSegmentData

Caution: Unexpected Segment Data from Linac Log The ‘beam on times’ in the
File log data that arrived from the
accelerator do not align with
Patient ID: [patient-id]
the ‘beam on times’
The timing of “beam on” events in the linac’s log file detected by IQM. This can be
for Field [field-id] does not match the “beam on” caused by high background
times detected by IQM. This is often caused by high signal, especially for fields
signal noise or high background signal, but could with very small segments.
indicate a treatment delivery issue.
Monitoring results cannot be evaluated for Field [field-
id].
The site’s “beam on” threshold setting (MinSignalRate)
should be reviewed and the cause of the detected
signal when the beam was not “on” should be
investigated.
Please contact IQM Support. Provide the latest IQM
Monitor log file and the corresponding Linac log file.
Message Code:
FieldErrorLinacData.BadSegmentData

IQM User Reference Manual (v1.35a SW-v1.8) 4-59


Field Error Dialog Message Issue
Caution: Unexpected Segment Data from Linac Log The log data that arrived from
File the Linac indicate that beam
was delivered when the IQM
Patient ID: [patient-id]
system did not detect a
At the time point reported in the Linac log as the start beam.
of beam delivery for Field [field-id], the IQM system did
not detect a beam. Monitoring results are
inconclusive.

Please contact IQM Support. Provide the latest IQM


Monitor log file and the corresponding Linac log file.

Message Code:
FieldErrorLinacData.BadFirstSignal

Caution: Beam Pause Not Detectable in Linac Log File This error occurs if Monitor is
running in a particular mode
Patient ID: [patient-id]
in which beam pausing is not
The beam has been paused, which is not supported supported. However, this
in this mode. Monitoring results for this field cannot be should not occur in a
evaluated.
correctly installed system.
In the future, consider interrupting (terminating) the
beam instead of pausing to obtain monitoring results.
Message Code: FieldErrorLinacData.BeamPaused

Caution: Too Many Fields Started before Segment More than two fields were
Data Arrived from Linac delivered when the log data
for the first field have not
Patient ID: [patient-id]
arrived yet; the first field will
Monitoring results for field cannot be evaluated. be abandoned and the
Delivery of two subsequent fields started before following field will be further
segment data for Field [field-id] arrived from the Linac. evaluated, if the log file
arrives in time.
IQM allows only one additional field to be started
while waiting for segment data for the first field to
become available from the Linac.
Message Code:
FieldErrorLinacData.TooManyFields

4.12 At the End of Monitoring

4.12.1 Closing the IQM Monitoring Software


The IQM Monitoring application can be allowed to run throughout the clinical
day. If it is closed while the IQM Detector remains powered on and the

IQM User Reference Manual (v1.35a SW-v1.8) 4-60


communication with the detector remains active, the electrometer in the
detector remains “on” as well to promote signal stability throughout the day.

If the IQM is powered “off” and removed from the Linac, e.g. for treatment
delivery with electron cones or for plans not intended to be monitored with IQM,
the IQM Monitor application can be left open or closed as the responsible user
prefers. If the application is left open, an orange Communication error will be
shown as long as the detector is powered “off” and not available. This System
Communication error will disappear as soon as the detector is powered up
again and communication is re-established.

4.12.2 Shutting Down IQM at the End of the Day


Close the IQM Monitor software by clicking on the “X” symbol in the upper right-
hand corner of the software display. Unless otherwise directed by your site
administrator, shut down the IQM computer by clicking or tapping the onscreen
Windows icon and selecting “Shut Down”. Always use the Shut Down command
instead of pushing the power button to turn off the computer to ensure that the
system can shut down cleanly.

Turn off power at the IQM Detector by pushing the power button on the front of
the device. Unless otherwise directed by the designated responsible user,
charge the detector so it is ready for use the next day. It is strongly
recommended to charge and store the detector in the treatment room
overnight to maintain thermodynamic equilibrium concerning atmospheric
conditions.

The IQM Transceiver may be left on or may be turned off at the end of the day,
as determined by the designated responsible user. If desired, turn off the IQM
Transceiver by flipping the switch on the bottom of the transceiver unit.

4.13 Charging the IQM Detector


The detector should be charged at the end of each treatment day, or more
frequently if required.

The detector must not be charged while in use. The detector is designed so that
the measurement electronics are disabled during charging and so long as the
device is attached to the mains power supply. Do not attempt to perform
measurements while charging!

Remove the detector with mount from the accelerator head and place it on a
flat, stable surface for charging. Plug in the detector charging cable at the
detector and connect to mains power.

IQM User Reference Manual (v1.35a SW-v1.8) 4-61


If needed, it is possible to charge the detector while it is mounted at the linear
accelerator as long as the accelerator is stationary while the power supply is
attached. Only charge the device when it is not moving. The user must ensure
that the detector and accelerator are stationary so that the power supply cable
cannot be dragged behind the device, thereby causing a potential hazard.

It is strongly recommended to remove the detector from the linear accelerator


head for charging to ensure that the cable is not overlooked or forgotten. If
charging the detector while mounted at the accelerator, always supervise the
charging process or otherwise ensure that staff are aware of the cable and that
it does not become a hazard.

Warning:
Only charge the device when it is not moving. Do not charge
the device when a patient is present, or touch the patient and
the device at the same time.
It is strongly recommended to remove the detector for
charging. If the detector is to be charged while attached to the
accelerator, the user must supervise the charging process or
otherwise ensure that staff are aware of the cable and that it
does not become a hazard.
Always verify that the cable has been removed before using the
accelerator. Do not leave the cable attached if the linear
accelerator head with the detector is to be rotated. The
movement of the cable being dragged when the accelerator
is rotated could pose a hazard if it drags across or against other
equipment, or if the cable could come in contact with a person
while being dragged.

Do not charge the device when a patient is present, or touch the patient and
the power supply at the same time.

Only use the power supply provided by iRT to charge the battery. If the power
supply is to be replaced, contact iRT for a replacement or for instructions. See
also section 3.13 Power Supplies.

Warning:
Only use the medical device power supplies supplied by iRT.
These have been tested and certified to IEC 60601-1 and IEC
60601-1-2 (EMC) and offer 2 means of protection (MOPs) in
conformance with the medical equipment safety standard.

IQM User Reference Manual (v1.35a SW-v1.8) 4-62


Do not use damaged power cables. If the cable appears damaged, contact
iRT to order a replacement.

When charging, the battery indicator LED on the detector will be illuminated
blue and the LED on the power supply will be illuminated green. After plugging
in the power supply to the detector, observe whether the blue battery indicator
LED comes on. If it does not come on, wait a few seconds and verify that the
power supply is securely attached and that the correct power supply has been
attached.

Note: attaching the wrong power supply may damage the detector and it may
damage the power supply.

When charging is complete, the blue LED on the detector will turn off. Note: the
LED on the power supply remains on (illuminated green) as long as the power
supply is plugged into mains.

The approximate time available for monitoring is displayed on the IQM


Workstation screen in the IQM Monitor application. If the device is charged each
day, typically, at least 10 hours of estimated time for monitoring will be shown.

Note: The power supply may react to ESD influences such as static electricity. If
the user touches the power supply and there is a discharge of static electricity,
or another source of ESD is nearby, the internal protection circuits of the power
supply may be activated and the power supply turned off. In this case, the blue
LED on the detector and the green LED on the power supply will both go out.
Disconnect the power supply from mains and from the detector and wait a few
minutes for the internal circuit to reset. Plug the power supply into mains and to
the detector again and observe whether charging continues normally (blue and
green LEDs stay on). If the problem persists, contact iRT Support for assistance.

The IQM Detector may not be connected to mains power supply or turned on
when it is being opened for service.

Note: the detector is designed so that no routine service by the user is required.
Always contact iRT for service or assistance in troubleshooting.

When removing the detector from the linear accelerator for charging, ensure
that it is placed on a flat level surface. Do not stack the detector on other
equipment or place anything on top of the detector since this could damage
or dirty the device. It is strongly recommended to charge and store the detector
in the treatment room overnight to maintain thermodynamic equilibrium
concerning atmospheric conditions.

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4.14 Special Considerations for Varian ADI users
Linear accelerators configured with Varian’s ADI communication interface
broadcast realtime events when a field starts and ends, but do not broadcast
segment-level events which are required for realtime monitoring of IMRT fields.
Instead, the Varian Linac console accumulates a log file of delivery events and
conditions and writes out the log file when the field delivery completes.

As soon as it is written, this log, a Trajectory Log or Dynalog file, depending on


the Linac model, is copied to a shared folder location on the department
network, from where IQM can read the log files. This very limited realtime
broadcast creates a few special considerations for using IQM.

For Varian RapidArc fields, the IQM System uses its own inclinometer readings to
assess which segment the Linac is delivering (based on the identified gantry
angle) and realtime monitoring is possible.

For Varian IMRT fields, the IQM System accumulates signal measurements and
processes the field delivery when the log file becomes available. Monitoring
results are typically available within seconds of the generation of the log file,
several seconds after the delivery of the field.

To guard against a dramatic over-delivery in the absence of realtime Linac


information, the total accumulated IQM signal is compared to the expected
total cumulative signal for the field in realtime with the Varian IMRT Progress Bar.

4.14.1 “Progress Bar” Presentation for IMRT Deliveries


For Varian IMRT fields monitored in Verification Mode, where no segment data
are available in realtime (during field delivery), a Progress Bar labeled “Current
Cumulative Signal vs. Reference” shows the total expected cumulative signal for
the moded up field delivery (as 100% indicator). This Progress Bar tracks the
accumulated signal as the delivery progresses (as a bar which is filling up).

IQM User Reference Manual (v1.35a SW-v1.8) 4-64


Figure 59 - Varian IMRT "Progress Bar" shows percentage of total expected cumulative signal
delivered so far, indicates if total measured signal exceeds the expected total

The watch and action levels defined for cumulative signal evaluation of the last
segment are displayed in the progress bar as +/- percentage values with dotted
lines around the targeted “100%” and are also labeled on the right-hand side of
the progress bar.

Particular conventions for the presentation of partial fields with the Progress bar
are:
• For complete single fields and for partial fields that represent the
interruption of a field that started normally, the 100% level in the Progress
Bar represents the cumulative expected signal for the entire field.
• For partial fields that represent the completion of a previous interrupted
delivery, the 100% level represents the remaining cumulative expected
signal for the portion of the field planned to be delivered now.

The tolerance levels applied to the progress bar reflect all the possibilities for the
last segment. The levels may be symmetric or asymmetric, based on treatment
technique or reference type, and will reflect a tolerance level defined with the
SHORT Rule if one applies to the current field.

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During field delivery, the signal indicator is shaded in blue unless one of these
deviations occurs:

• If the measured signal exceeds the total expected + watch level, the
progress bar is shaded yellow and the System Warning “ding” sounds.
• If the measured signal exceeds the total expected + action level, the
progress bar is shaded red, and the familiar alarm message, alarm sound
and red shading of the Monitor application background occur.

When beam delivery has completed for the field and Monitor is waiting for the
Linac log file to provide detailed monitoring results, the progress bar is color
coded based on the measured total cumulative signal as follows, assuming the
signal has not already exceeded the total expected + watch or action
percentage value during delivery of the field, in which case it is already shaded
yellow or red:

• If the total signal is within tolerance, the bar is shaded green, but in a
lighter green tone to indicate the provisional nature of the result.
• If the total signal is less than the lower threshold of the watch level, the
bar is shaded yellow.
• If the total signal is less than the lower action level threshold, the progress
bar is shaded red.
Note: no alarm dialog and sound will be presented yet at that stage
because the beam is already delivered. The IQM system will present
conclusive field monitoring results as soon as the Linac log file has been
made available and analyzed, including an alarm dialog and sound if so
indicated in the final field evaluation.
• Field Delivery Interruption:
If the MU delivered value reported by the Linac broadcast system (ADI)
at the end of the field is smaller than the MU planned to be delivered per
treatment plan or per Field Start Linac broadcast message, the IQM
software assumes that the field was interrupted, i.e., delivered partially.
The Progress Bar will be re-calculated such that the 100% level
corresponds to the expected signal for the delivered portion of the field.
The Progress Bar will be shaded light green, yellow, or red based on the
cumulative signal measured during the partial field compared to the
expected cumulative signal for that portion of the field. The Monitoring
Status area will be updated to “Field partially delivered (waiting for
segment data).”

Note that for Varian Field Sequence deliveries, the progress bar remains blue
until the entire sequence is completed.

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Finally, when the Linac log file arrives (Field End event), IQM performs the
conclusive evaluation of the signal data. Based on this evaluation, the final
monitoring result will be presented in the Monitoring Status area, and action-level
deviations or other detected deviations reported. e.g., if the cumulative signal
was in tolerance range, but segment-by-segment action-level deviations
occurred, a corresponding alarm will be presented. The progress bar shading will
be updated to match the color of the Monitoring Status Line, which reflects the
conclusive monitoring result of the field.

4.14.2 Beam Pausing


IQM Monitor is designed to suspend monitoring when the beam is paused and
to automatically resume monitoring when un-paused.

If beam pauses appear not to be recognized and handled by IQM, the user
should contact Support so that the settings can be verified.

4.14.3 Overlapped Fields


When using Varian linacs with realtime ADI broadcast and log files which are
made available to IQM after the beam was delivered, IQM provides monitoring
results for non-RapidArc fields within seconds of the writing of those log files.

It sometimes happens that the Varian control system has not created, saved and
copied the log file for a field before the next field is moded up. In some cases,
beam delivery for the next field may even start before the log file is available to
IQM.

IQM Monitor always displays field information for the field currently broadcast.
This means that when a new field is moded up, its demographic information,
graphs and segment tables will be shown, even if the monitoring results for the
previously delivered field are not yet available.

In this case, the log-file based monitoring results will be saved in the IQM
database, but will not be shown onscreen in Monitor during treatment delivery
monitoring. If the monitoring results include an alarm, Monitor will enter the alarm
state and an alarm dialog will be shown, indicating that the alarm is for a field
already delivered.

4.14.3.1 Field Error “Too Many Fields”


If more than one field is moded up at the console before the log for the first field
is available, Monitor does not process the first field’s log and cannot save the
signal measurements it acquired for the first field. This may happen if the first field
is long, and is followed by a very short field.

IQM User Reference Manual (v1.35a SW-v1.8) 4-67


An error message with message code “FieldErrorLinacData.TooManyFields” is
shown to inform the user that monitoring results for the first field will not be
created and IQM monitors the second and third fields, displaying their results as
their logs become available. See Table 6 for details of the error message.

If the “Too Many Fields” error is seen, the user should consider waiting briefly after
field delivery before moding up the next field.

4.15 Automated Field Sequence Handling (AFS)


Linear accelerator control systems support different methods of grouping
treatment fields together for more efficient delivery. Monitor handles most of
these methods routinely.

One way of grouping treatment fields happens at the linac console immediately
prior to delivery which is referred to as automated field sequences (AFS) in this
manual. In this case the linac console broadcasts the Field ID of only the first field
in the group, with an ‘MU to be delivered’ value that represents the total MU for
all the fields in the group. All treatment fields being grouped this way belong to
the same treatment plan.

To handle this approach to grouping fields, when the linac console broadcasts
a Field ID with an MU to be delivered that is higher than the MU assigned to the
single field in the treatment plan, Monitor checks all fields in the current version
of the plan to which the broadcast Field ID belongs for a group of plans with a
total MU equal to the broadcast MU. If such a collection of fields can be found,
Monitor uses the gantry and collimator angles at which each field is delivered to
identify the order in which the fields are delivered and monitors each in turn. On
Elekta machines, the Energy value may also be used to distinguish each field.

4.15.1 Multiple Field Display for Automated Field Sequences (AFS)


When fields are grouped for delivery as an AFS, Monitor shows all fields delivered
in the sequence onscreen at the same time, adding each field to the right of
the graph areas and to the bottom of the segment tables.

IQM User Reference Manual (v1.35a SW-v1.8) 4-68


Figure 60 - Multiple fields delivered as a single sequence shown concurrently in Monitor

In addition, the phrase “[in sequence]” appears in the Monitoring Status line
throughout sequence delivery to identify that the current field is monitored as
part of a sequence.

Figure 61 - Status line messages during AFS deliveries include the phrase "In Sequence"

4.15.2 Automated Field Sequence (AFS) System Warnings


AFS system warnings happen when the linac console broadcasts a Field ID with
an MU value the linac intends to deliver that is higher than the MU assigned to
the field in the treatment plan. When this happens, MON checks all fields in the
current version of the plan to which the broadcast Field ID belongs for a group
of plans with a total MU equal to the broadcast MU. If it does not find an eligible
set of fields to be delivered in sequence, one of the AFS system warnings occurs.

The AFS-related system warnings have the special behavior that MON runs in
Display mode and that no dialog is shown, although the status lines are shaded
yellow and a ‘Ding’ sounds to alert staff that IQM cannot verify the sequence or
the next fields of a sequence.

IQM User Reference Manual (v1.35a SW-v1.8) 4-69


Table 7 - Conditions for AFS System Warnings with Corresponding Status
Messages

System Warning Messages in Monitoring Status Condition


Area
1. [Status] - Caution: Field not verified due to invalid MU to be delivered as
Planned MU (FieldStartNoSequence) broadcast by the linac is
larger than the MU specified
where [status] is one of “Field loaded”, “Field in for the broadcast Field ID in
progress” or “Field completed (waiting for the treatment plan, and no
segment data)”. The latter status is only valid for eligible sequence from the
Varian cases. same treatment plan exists for
the given total MU and
2. Field not verified: invalid Planned MU
starting Field ID.
(FieldStartNoSequence)
Occurs only for non-VMAT
fields

1. [Status] - Caution: Field not verified due to MU to be delivered as


ambiguous field sequence broadcast by the linac is
(FieldStartAmbiguousSequence) larger than the MU specified
for the broadcast Field ID in
where [status] is one of “Field loaded”, “Field in
the treatment plan, and an
progress” or “Field completed (waiting for segment
eligible sequence exists, but
data)”. The latter status is only valid for Varian cases.
with 2 fields at the same
2. Field not verified: ambiguous field sequence combination of beam energy
(FieldStartAmbiguousSequence) / fluence and gantry /
collimator angle (including
uncertainty)

Occurs only for non-VMAT


fields

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5 Using IQM Review

5.1 Main Functions, Access Permissions and Responsibility


IQM Signal Records, i.e. treatment signal records, measured references and
calculated references, may be reviewed and compared in the IQM Review
application. IQM Review also allows the user to select a calculated or measured
signal record as the “baseline” for each treatment field, the reference record
used for verification in subsequent monitoring sessions.

IQM Review is only for reviewing data; it does not interact with the measuring
hardware or the Linac control system during treatment. Therefore, it is typically
installed on a laptop or desktop PC used primarily by the designated responsible
user, or other staff member(s) assigned to review IQM results. Using the function
to change the baseline, as mentioned above, will impact how results are
presented and interpreted.

Caution:
Changing the baseline in Review will determine against which
criteria subsequent treatment deliveries will be verified. Only
trained and authorized persons should change the baseline.
Inform staff accordingly.

Although IQM Review can be run at the IQM Workstation, it should not be run at
the same time as Monitor.

Caution:
Do not run IQM Review at the same time as IQM Monitor on an
IQM Workstation. The presence of other applications or
windows, including minimized windows, may cause IQM Monitor
messages, including System Errors and Clinical Alarms, to be
improperly displayed or to not be displayed at all. In this case,
the user may miss System Error or Clinical Alarm messages, and
not be aware of system problems or detected deviations.
Inform all staff accordingly.

IQM User Reference Manual (v1.35a SW-v1.8) 5-1


Only Active Directory Users who are member of the groups IQMMONuserGroup
or IQMREVuserGroup have the required permissions for the IQM Database and
will be able to run the IQM Review application.

Caution:
The responsible user(s) should determine which computer(s) will
be used with IQM Review, how access to the Review app is
managed and who will be responsible for managing the
software installation, such as updating the Review software and
performing updates of the operating system as required, in
particular, security updates.
It is recommended that the responsible user agree with
installation staff how Review is to be installed and managed and
who will have access to Review and maintain the configuration
accordingly.
Maintaining the Review app is the responsibility of the user.
Contact Support for assistance or more information if needed.

5.2 Selecting a Patient for Review


IQM shows records for one patient at a time. When the user double-clicks the
Review application icon to start Review, a dialog to open a patient file
immediately appears.

Figure 62 - Review Application Patient Selector

Choose a patient by clicking its Patient Name or ID and then clicking “Open.”
Alternatively, double-click on the patient record.

IQM User Reference Manual (v1.35a SW-v1.8) 5-2


5.3 Review Application Display
The main Review application window appears.

1 2 3 4

5 9 8

10

11

Figure 63 - Review Application display

The main elements of the Review application window include:

1. “Linear Accelerator and Detector” selector (acts like a filter for the
patient records)
2. “Select New Patient” button
3. Patient information area
4. “Set Patient Inactive” button
5. Treatment record selector
6. “Set/Clear Baseline” buttons
7. Segment-by-Segment Table
8. Reference record and settings currently displayed
9. Cumulative Graph
10. Segment-by-Segment Graph
11. Signal Measurement Record Notes

IQM User Reference Manual (v1.35a SW-v1.8) 5-3


5.3.1 Selecting a New Patient
The “Select New Patient” button displays the Open Patient dialog shown in
section 5.2 and allows IQM records for a different patient to be shown.

5.3.2 Selecting Signal Records to Display


Review identifies the patient at the top middle of the display and provides a
drop-down menu to select a linear accelerator and detector combination at
the upper left. This selection box serves as a filter: only those records are shown
which are valid for the selected linear accelerator and detector combination.

Only records for the same field delivered with the same Linac and IQM Detector
can be overlaid and compared to one another.

Figure 64 - Linac and IQM Detector combination selector.

Below the ‘Linac / Detector’ drop down menu, a selection tree is used to choose
a ‘Field #’ and the records that are available for the field. Expanding a ‘Field #’
shows the plan versions that have been imported (as Dicom RT plan files) for this
field, listed by their imported date and time stamps.

Note: If there are several plan versions listed under a field, Monitor will always
load the plan that was last imported.

Figure 65 - Selection tree initial display. Expanding a Field shows the plan versions available

IQM User Reference Manual (v1.35a SW-v1.8) 5-4


Expanding a plan version shows all the Calculated Reference, Measured
Reference(s) and Treatment Record(s) measured with the selected Linac and
detector combination for this field in this plan version:

REF C = Calculated
Reference record

REF M = Measured
Signal records Reference record. The
green flag indicates that
Treatment
this record is currently set
records
as the baseline for
monitoring new deliveries
of this field.

Figure 66 Selection tree with Reference and Treatment Records

Caution:
If multiple plan versions are present, each plan version will have
a baseline record associated with it to be used for verification
of new deliveries of the field. However, only the most recently
imported plan version and corresponding baseline will be
loaded by IQM Monitor when the field is delivered next time.

Caution:
Changing the baseline in Review will determine against which
criteria subsequent treatment deliveries will be verified. All users
log-on permissions to start Review also automatically have rights
to change the baseline. Only trained and authorized persons
should change the baseline.
Inform staff accordingly.

Each record is identified by the date and time it was created.

• Calculated Reference records are identified with “REF C” preceding their


creation date and time.
• Measured Reference records are identified “REF M” preceding their
creation date and time.

Checking the box next to a record displays it in the graphs and segment table.

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One, several or many records may be selected.

Figure 67 - Selection tree with multiple records selected

The color bars to the right of each selected record identifier in the selection tree
show the color in which each record is graphed.

5.3.3 Setting a Patient Inactive


To “hide” a particular patient’s data, including all calculated fields and
treatment records for all plans imported for the patient, click the “Set Patient
Inactive” button at the top right of the Review display.

This action does not delete the patient data from the IQM database. However,
it does make the patient data invisible and completely inaccessible within IQM
Review and in IQM Monitor. There is no “Undo” action available. If a field for the
inactivated patient is loaded for delivery at the Linac, Monitor will run in Display
Mode, as the patient will be ‘unknown’.

When the ‘Set Patient Inactive’ button is clicked, a confirmation dialog appears,
prompting the user to confirm that all data for this patient should be set to
“Inactive” in the IQM Database.

IQM User Reference Manual (v1.35a SW-v1.8) 5-6


Figure 68 - Confirmation dialog when the ‘Set Patient Inactive’ button is activated

When this action is confirmed, the patient’s data will be cleared from the Review
display, including patient information, the per-segment table and both graphs,
and the “Select Patient” dialog will be shown again, to allow a new patient to
be loaded.

5.3.4 Reference (Corridor) Display in Review


When IQM Monitor records a treatment, it stores the applied software
configuration settings for each field in the IQM Database, including Watch and
Action level settings.

If one treatment record is selected in the selection tree, the reference record
shown as the baseline and the values defining the width of the corridor(s) shown
in the Cumulative and/or Segment-by-Segment graphs will correspond to the
settings stored with that record.

If more than one treatment record is selected in the selection tree, the values
defining the reference displayed and the width of the corridors will correspond
to the treatment record first selected by the user. For clarity, the ID (date and
time) of the treatment record from which corridor settings are displayed are
indicated in the upper right corner of each graph:

This date and time can be used to identify the corresponding treatment record
in the selection tree.

To display several treatment records against corridor settings from a different


record, de-select all the records and re-select them starting with the one with
the desired watch/action level settings.

IQM User Reference Manual (v1.35a SW-v1.8) 5-7


Note: For treatment records recorded with a software version earlier than v1.4,
the settings were not yet stored in the IQM Database. In this case, the statement
reads “Using settings from treatment --” to indicate that no settings were loaded.

The Watch and Action level settings are indicated in numbers below each
graph, and graphically as corridors around the applied reference, while the
selected measured treatment record is displayed as data points. The
background color convention for the data points is as in the IQM Monitor
application, i.e. signal counts in Tolerance range are not colored, signal counts
in Watch range are colored light yellow and signal counts in Action range are
colored light red.

Figure 69 - Review showing the Watch and Action level settings that were in effect at the time of
treatment field delivery below each graph.

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In the example of Figure 70, in the Cumulative graph, the treatment record signal
appears with the reference record against which it was monitored and
evaluated with the Tolerance, Watch and Action corridors in place at the time
of monitoring, indicated by time and date in the upper right corner of the
graphs. In the Segment-by-Segment graph, no deviation level settings were in
effect, so the Treatment Record Signal is presented as a simple line.

Figure 70 - Selected treatment record shown against a Measured Reference record with
Tolerance, Watch and Action corridors in the Cumulative graph

5.3.5 Segment Table Display in Review


The individual segment signal values from the current baseline reference are
shown in the “Baseline” column of the Segment Table (lower left). Each selected
treatment record has a column identified by date, listing the Signal Counts value
for each measured segment in the field.
Each selected treatment record’s column shows the segment’s percent
deviation from the baseline signal. If a single record is selected, the signal counts
and absolute difference also appear (see the Segment Signal Tables below).

IQM User Reference Manual (v1.35a SW-v1.8) 5-9


Figure 71 - Segment Table with a single record Figure 72 - Segment Table with multiple
compared to its baseline records compared to the baseline of the first
selected treatment record

The segments are compared against the baseline and evaluated with the
corresponding Watch and Action level thresholds.

• Segments with signal deviations larger than the Action level threshold are
shaded red.
• Segments with signal deviations larger than the Watch level threshold are
shaded yellow.
• Segments which were not delivered in a selected treatment record are
shaded in grey.

For Cumulative criteria, the segments with deviations are only shaded in the
Cumulative graph, as the table shows only Segment-by-Segment deviations.

Figure 73 - Cumulative graph showing segments with Watch level deviations, shaded yellow

IQM User Reference Manual (v1.35a SW-v1.8) 5-10


For Per-Segment criteria, the segments are shaded in both the Segment-by-
Segment graph and the Segment Table (see below).

Figure 74 - Single record shown with segment deviations in Action range,


shaded red in the Segment-by-Segment graph and Segment Table

5.3.6 Signal Measurement Record Notes


At the bottom of the Review application window, a text box lists special events,
if any occurred during monitoring of one of the selected treatment records.

The event is presented as follows:


[date] [time] [event]
where [date] [time] is the date and time of the treatment record in which the
event occurred, and [event] is the recorded event. Events recorded include
alarms other than signal deviations, including gantry errors and mismatches
between planned and broadcast energies, field errors, partial field delivery, and
environmental condition messages.

Figure 75 - Example of info shown in the Signal Measurement Record Notes section. Here, a field
error FieldErrorInterSignal (signal between segments) occurred, and due to the error, not all
segments were monitored.

For more information about a specific event, please consult Table 5Table 5 Other
Conditions for Clinical Alarms and Table 6– Messages for Field Error Dialogs.

IQM User Reference Manual (v1.35a SW-v1.8) 5-11


5.4 Setting the Baseline for Future Deliveries of a Field

Caution:
Changing the Reference record used as the baseline for future
deliveries of a field has a direct impact on what will and will not
cause Clinical Alarms and watch-level alerts. The baseline
should only be changed by a qualified person trained and
authorized to do so, typically a person with administrator rights.
To support this, only members of specific Active Directory groups
have permission to run IQM Review and connect to the IQM
Database.

The ‘baseline’ record is the Measured or Calculated Reference Signal that will
be used by IQM Monitor when it monitors a new delivery of a specific field. In the
Segment Signal table in the lower left corner, the “Baseline” column displays the
signal values of the baseline reference record.

Caution:
If multiple versions of the same treatment plan are present in
Review, each plan version will have a baseline record
associated with it. However, only the most recently imported
plan version and corresponding baseline will be loaded by IQM
Monitor when the field is delivered next time.

If calculation is enabled for new plans being sent to IQM (determined by the
“CalcMode” parameter setting, refer to section 6.4.1.6 Import and Calculation
Settings (IQM Server only), the default baseline record for the field’s first delivery
will be the Calculated Reference. When the field is delivered for the first time
and a Signal Record is stored in the database (Monitor runs in “Record mode”),
the first Measured Reference is created automatically from the Measured Signal
Record and is set as the new baseline. Therefore, for most fields, at least two
Reference records will exist, an initial Calculated Reference and the subsequent
Measured Reference.

If calculation is disabled for new plans being sent to IQM, the default baseline
record used by IQM Monitor will be the first Measured Reference created from
the first Signal Record, if one exists for the selected field.

The user can define the default for when IQM will use the Measured or
Calculated Reference, as described below in 5.4.3 Setting an Update Strategy
for Measured Reference Records.

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In many cases, subtle differences occur between the planned and actual field
deliveries, due to characteristics of the linear accelerator hardware and control
system. These differences may make the Measured Reference record a better
baseline for ongoing deliveries of the field.

To set a specific, different Reference record as the baseline for a field, click the
desired Reference record to highlight it, and click the ‘Set selected record as
baseline…’ button (see the following illustration, below). The green flag icon will
now appear next to the Reference record against which future deliveries will be
compared.

Initial
Baseline (3) New
Baseline
record set
(1) Select
Treatment
Record

(2) Click
to set
new
Baseline

Figure 76 – To set a different reference record as the baseline, (1) Highlight the desired REF
record, and (2) click the "Set selected record as baseline..." button. (3) The green flag icon
denoting the baseline moves to the selected reference.

5.4.1 Creating a New Measured Reference from a Treatment Record


A Measured Reference record is automatically saved after the first monitored
delivery of each field, but later Treatment records may also be “promoted” to a
Measured Reference record.

A Treatment record for a field delivery during which a field error occurred, or
where the field was incomplete (‘partial field’), is not automatically saved as a
new Measured Reference and may not be selected later as the baseline.

A Treatment record where action-level deviations have occurred will not be


automatically saved as the new Measured Reference, however, if desired, the
user may manually select the record containing an action-level deviation and

IQM User Reference Manual (v1.35a SW-v1.8) 5-13


select it as the Measured Reference. More information about which criteria IQM
applies to determine when a measured signal record is automatically saved as
a Measured Reference may be found in 4.1.3.1 Criteria for Recording Measured
Reference Records.

To manually create a Measured Reference from an existing treatment record,


select only that record and click the “Set selected record as baseline…” button
as described above.

A new “REF M” record will appear at the top of the list of records and will be
automatically set as the baseline for new deliveries.

(3) New
measured
reference
created
(1) Select and set as
Treatment Baseline
Record

(2) Click to
set new
Baseline

Figure 77 – To create a Measured Reference from a measured treatment record, (1) select a
single treatment record and (2) click the "Set selected record as baseline..." button. The new “REF
M” record will appear at the top of the Record(s) list, below any pre-existing reference signals,
and will be automatically set as the new baseline for future deliveries of this field.

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5.4.2 Clearing the Current Baseline Reference Record
If the user wishes NOT to verify the next delivery of a field against any of the
existing reference records for the field, the current baseline can be cleared. In
this case, Monitor will run in Record Mode during the next delivery, and the new
treatment record will be saved as the new Baseline (assuming it meets the
criteria of being complete, non-errored and without alarm conditions.)

(1) Select
current (3) Baseline
Baseline has been
cleared.

(2) Click to
clear
Baseline

Figure 78 – To clear the Reference Record currently set as the Baseline for future deliveries of this
field, (1) select the flagged current baseline and (2) click the "Clear selected baseline" button.
The flag will be removed and the reference record de-activated. The next time this field is
delivered, MON will run in Record mode, not Verification mode.

5.4.3 Setting an Update Strategy for Measured Reference Records


IQM’s standard operation on the first delivery of a field is to monitor against the
Calculated Reference, if one exists, and record a Measured Reference, which is
then used as the baseline for the next and all subsequent deliveries of the field,
unless or until the user explicitly sets another record as the baseline.

IQM can also be configured to continue to monitor against the Calculated


Reference (i.e. to NEVER automatically create a Measured Reference) or to
update the Measured Reference every time the field is delivered (i.e. to ALWAYS
create a Measured Reference.)

These options are set in the IQM.Config.ini file, under the keyword “Reference
Update Strategy” in the [AppSettings] section. See section 6.4.1 about editing
this configuration setting.

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5.5 Creating Reports in Microsoft Excel from Review Data
The Segment Table in the IQM Review application is selectable and may be
copied to Microsoft® Excel® (further referred to as Excel) and other spreadsheet
programs.

To copy the entire Segment Table, click in the top left cell of the Segment Table.
Scroll to the right and down to the furthest, bottom-most cell in the table
(highlighted as blue when selected, see below). Alternatively, select any one
cell in the table and press [CTRL] + [A] to select all cells in the table.

Figure 79 - Selecting cells to copy results to Excel. The values highlighted blue
are selected and will be copied to the Windows Clipboard / to Excel

Press the ‘Copy’ keyboard shortcut [CTRL]+[C] to copy the data to the Windows
Clipboard. Open Excel (or another spreadsheet program) and press the ‘Paste’
keyboard shortcut [CTRL]+[V] to paste the data to the spreadsheet.

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Figure 80 - Pasting the results into Excel

Note that the column headings are not part of the copied data block. Restore
the column headings manually if using for a report or keeping data for later
reference.

Figure 81 - Column headings may be added manually in Excel

Once all records the user wishes to compare are assembled in Excel, consider
adding identification and analysis information, such as
• Patient ID, Field ID, linac and detector title/header information
• Average, mean and maximum deviation, by day/record or for
complete set of records

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The IQM Reporter service also generates an Excel file field parameters and
segment data suitable for further formatting by the user.

5.6 Creation of Reports by IQM Reporter


The IQM Reporter provides a Windows service, which runs in the background
and automatically collects and organizes data from the IQM Database into
formatted reports for QA documentation. IQM Reporter generates reports as
PDFs and creates formattable report files in Excel to support further processing
and/or statistical analysis.

Information about IQM Reporter can be found in the IQM Reporter Extension for
IQM - User Manual.

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6 Managing the IQM System
Each IQM user site must have a designated responsible user who receives
specialized training to configure the system, set Clinical Rules and define their
criteria, and otherwise administer the IQM installation, as described in section
3.2.2 Designation of a Designated Responsible User. The hospital or clinic may
name more than one user with responsibility and authority to perform these tasks
or divide responsibility and authority for tasks between designated responsible
users.

This designated responsible user is usually a medical physicist, and typically an


active participant in clinical operations. This chapter addresses the system
management tasks performed by designated responsible users (some in
collaboration with medical or IT staff):

• Configuring Clinical Rules


• Understanding mandatory segment grouping and configuring optional
segment grouping and signal smoothing rules
• Accounting for the IQM Detector in treatment planning
• Configuring data files and folders used with IQM
• Responding to System Errors

6.1 Clinical Rules (Criteria settings for Clinical Alerts & Alarms)
The Clinical Rules define the thresholds and limits for what deviations are
considered:
a) in the range of normal operation of the Linac (normal level/tolerance)
b) out of the range of normal operation but small enough to investigate after
the treatment concludes (Watch level)
c) out of the range of normal operation and large enough to issue a Clinical
Alarm (Action level).

Caution:
The Clinical Rules are only applied if IQM Monitor is operating in
Verification Monitoring Mode.

The designated responsible user is responsible for setting the percent deviation
thresholds that define these ranges, and for establishing departmental protocols
for how to respond to treatments in the Action (‘Clinical Alarm’) and Watch
ranges.

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Medical physics staff will determine the appropriate settings for these rules. In
keeping with this responsibility, only the user IQMuseradmin and users who
belong to the IQMmedphysGroup Security Group in the Active Directory may
edit the IQM.Config.ini file, where these settings are stored. (Other users can be
given this permission, as implemented during installation).

Note: It is responsibility of the user institution to determine and implement which


staff members shall be assigned to the IQMmedphysGroup Security Group and
other Security Groups per section 3.5 Integration in the Radiation Therapy
Department Network.

Caution:
The criteria set in the Clinical Rules define how IQM will perform
the intended use of verifying treatment delivery. Only deliveries
outside these criteria will result in Clinical Alarms being
presented to the user. These criteria should only be changed by
a user with the knowledge and authority to do so.

To review and edit the Clinical Rules, in File Explorer, navigate to the IQM
installation folder, by default “C:\Program Files (x86)\IQM\” and open the
IQM.Config.ini file using a text editor. More information about managing the
software configuration settings is found in section 6.4.2 [Rules] Section (IQM
Workstation only).

All clinical rules are specified in the [Rules] section of the IQM.Config.ini file.

6.1.1 Classification of Clinical Rules


Each Clinical Rule is classified with three to five differentiating parts, indicating
to which treatments it applies:

[Treatment Type].[Reference Type].[Level].[Criterion Type].[“Short”] = [value(s)]

Rule classification

Example:
DynamicIMRT.Calc.Watch.Cumulative.Short = 2.0

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6.1.1.1 Treatment Type
The [Treatment Type] may be “VMAT”,“StepIMRT”, “DynamicIMRT” or “IMRT”.

• VMAT refers to arc therapy, often called “VMAT” by Elekta and


“RapidArc” by Varian. This technique involves continuous gantry and MLC
movement throughout the beam delivery.
• StepIMRT refers to treatments including static fields as well as step-and-
shoot IMRT. These techniques involve static gantry and MLC positions
during beam delivery.
• DynamicIMRT refers to treatments including static gantry positions and
continuous MLC movement during beam delivery. This technique is often
called “sliding window IMRT” or DMLC-IMRT.
• IMRT refers to all non-VMAT treatments, unifying StepIMRT and
DynamicIMRT for backward compatibility with previous versions of the
IQM Software. It is not possible to set an IMRT-rule and a
Step/DynamicIMRT-rule at the same time.

Differentiating between these Treatment Types responds to the differences in the


IQM Signal deviation uncertainty associated with each Type.

Dynamic vs Static beams: Dynamic treatment fields (VMAT and DynamicIMRT)


are usually divided into ca. 30 – 200 beam segments, whereas StepIMRT beams
only have ca. 1 – 15 beam segments. Therefore, the IQM Signal for dynamic
beams is usually distributed across a higher number of individual data points (i.e.
segment groups), as compared to StepIMRT fields. The signal deviation
uncertainty per segment increases with (i) decreasing time per segment and (ii)
an increase in dynamic components during beam delivery, so DynamicIMRT
treatments have higher uncertainty than StepIMRT fields. Since the Watch Level
is typically derived from the IQM Signal deviation uncertainty (i.e. standard
deviation), the Clinical Rules for the PerSegment Signal, or the initial section of
the Cumulative Signal may be set to lower values for StepIMRT than for VMAT
and DynamicIMRT.

Segment boundary determination: IQM Monitor employs different methods to


determine which portion of the measured IQM Signal is allocated to which beam
segment. For VMAT, segment boundaries are detected by matching the
planned gantry angles with the ones measured by the built-in IQM inclinometer.
For StepIMRT and DynamicIMRT, either the information from the Elekta iCom-
interface, or the data from the Varian Trajectory/Dyna-Log-Files is used for IQM
Signal distribution. The IQM Signal deviation uncertainty differs between
treatment techniques because these methods inherit different uncertainties. For
VMAT, the inclinometer measurement and gantry movement uncertainties
contribute to a higher fluctuation of IQM Signal deviations, as compared to
StepIMRT, where the well-defined segment boundaries are determined via either

IQM User Reference Manual (v1.35a SW-v1.8) 6-3


the related iCom messages (Elekta), or the according Linac Log-File (Varian). In
contrast, the limited sampling rates of iCom messages or Linac-log-file entries
may lead to a higher IQM Signal deviation uncertainty for DynamicIMRT, where
ca. 2 to 15 beam segments per second are typically delivered and therefore
segment boundaries cannot be determined as precisely.

Figure 82 shows the (Cumulative) tolerance corridors for VMAT, DynamicIMRT


and StepIMRT as determined at an Elekta Linac and derived from the 2.5-fold
standard deviation of segment-specific deviations between calculated and
measured IQM Signals. The tolerance corridor for dynamic treatment techniques
decreases within the initial segments before levelling off at the same threshold
as the StepIMRT corridor which is constant throughout the whole beam delivery.
In this case, the DynamicIMRT tolerance corridor decreases to a constant
threshold earlier in the delivery as compared to the VMAT tolerance corridor.

Figure 82 – Graphical illustration of the first 50 segments of clinically employed rule sets for different
Treatment Types. The corridors were determined at an Elekta Linac based on the 2.5-fold segment-
specific standard deviation of the deviations between calculated and measured IQM Signals.

6.1.1.2 Reference Type


The [Reference Type] is an optional part any may be “Measured” or “Calc”.

• Measured refers to field measurements which are compared against a


measured reference.
• Calc refers to fields measurements which are compared against a
calculated reference.
• The tolerance values for the “Measured” Reference Type must be greater
or equal to the parallel values for the “Calc” Reference Type.

IQM User Reference Manual (v1.35a SW-v1.8) 6-4


• If a Clinical Rule is set in combination with a certain Reference Type for a
particular Treatment Type, it is mandatory to set an additional Clinical
Rule for the same Treatment Type and the other Reference Type.
• If the rule definition does not include Reference Type, the rule will be
applied to measurements with either Reference Type.
• For a particular Treatment Type, either both Measured and Calculated
Reference Type rules must be defined OR only a rule without Reference
Type can be defined. It is not possible to set a Clinical Rule for a certain
Treatment Type without a specified Reference Type and another one with
“Measured” or “Calc” at the same time.

Allowing the user to set different tolerances for different Reference Types
responds to the differences in the IQM Signal deviation uncertainty related to
Reference Type.

If a Calculated reference is set, the uncertainty of IQM Signal deviations mainly


depends on three factors:

• Beam delivery uncertainty


• IQM measurement uncertainty
• IQM calculation uncertainty

If a measured reference is set, the IQM calculation uncertainty is no longer


present, which decreases the overall fluctuation of IQM signal deviations. Since
the Watch Level is typically derived from the IQM Signal deviation uncertainty
(standard deviation) the relevant Clinical Rule may be set to lower values for
Measured Reference Types as compared to Calculated ones.

Figure 83 shows the (Cumulative) VMAT tolerance corridors as determined at a


Varian Linac and derived from the 2.5-fold standard deviation of deviations
between measured and reference IQM Signals.

The levels for the “Measured” Reference Type are tighter than the “Calc”
thresholds due to the lower IQM Signal deviation uncertainty associated with the
absence of IQM calculation uncertainty.

IQM User Reference Manual (v1.35a SW-v1.8) 6-5


Figure 83 – Graphical illustration of the initial 50 segments of Clinical VMAT Rule sets for different
Reference Types. The corridors were determined at a Varian Linac based on the 2.5-fold segment-
specific standard deviation of the deviations between measured and reference IQM Signals.

6.1.1.3 Level Type


The [Level] may be “Watch” or “Action”.

• Watch - Watch-level deviations are considered to be outside the


expected range of machine behavior but are small enough to be
clinically insignificant. By definition, their impact is small enough that
treatment may be continued.
• Action - Action-level deviations are sufficiently outside the expected
range of machine behavior so as to be clinically significant. By definition,
their impact is large enough that Medical Physics staff determines that
they should be reported as Clinical Alarms so that treatment should be
interrupted immediately (or whatever procedure the responsible Medical
physics staff have defined as department policy for these conditions).

As per the definition, the Action Level values must be greater or equal than the
Watch Level values.

6.1.1.4 Criterion Type


The [Criterion Type] may be “PerSegment” or “Cumulative”.

• PerSegment means that each segment’s signal counts are compared


to the reference signal counts for that one segment. In IQM Monitor, the
results of Per Segment rules are shown in the Segment Signal Table and
the Per-Segment graph. Per Segment criteria are recommended for IMRT
(non-VMAT) fields only.

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• Cumulative means that the total accumulated signal counts through
the current segment are compared to the reference cumulative signal
counts through the current segment. In IQM Monitor, the results of
Cumulative rules are shown in the Cumulative Signal Table and the
Cumulative graph. Cumulative criteria are recommended for both IMRT
and VMAT Treatment Types.
In IQM Monitor, it is mandatory to set a Cumulative Watch Level for all
Treatment Types, whereas setting an Action Level is optional for all
Treatment and Criterion Types.

6.1.2 Values of Clinical Rules


The [value(s)] item defines the percent (%) deviation threshold(s) that span the
Tolerance, Watch and Action ranges. These are presented as a green tolerance
corridor and ranges demarcated by red dashed lines around the baseline signal
record, as displayed in the graphs displayed in IQM Monitor (Verification Mode),
and in IQM Review.

Tolerance level values are typically defined with one decimal place (N.N%) but
may have up to two decimal places (N.NN%) to provide a smoothly decreasing
corridor.

Clinical Rules can define constant or decreasing (narrowing) tolerance corridors,


and these may be defined asymmetrically above and below 0%. Some
additional rules are available to further customize how the tolerance levels are
applied.

6.1.2.1 Constant Tolerance Corridor


The values for the Clinical Rules are referred to as Percent Error in IQM error
messages. The values are set in the same way for each Treatment Type,
Reference Type, Level and Criterion Type. As an example, a Cumulative Watch
Level of ±4.5% for VMAT beams that is applicable to both Reference Types would
be set as follows:
VMAT.Watch.Cumulative = 4.5

Figure 84 shows the resulting constant course of values for the above-mentioned
rule for the first 10 beam segments.

IQM User Reference Manual (v1.35a SW-v1.8) 6-7


Figure 84 – Graphical illustration of the values of a constant Watch Level over the course of 10
beam segments.

6.1.2.2 Decreasing Tolerance Corridor


For dynamic treatment techniques, it may be observed that the IQM Signal
deviation uncertainty decreases during the initial beam segments of a field
delivery. This effect may be caused by the following factors:

• As described in section 6.1.1.1, the IQM Signal deviation uncertainty for


dynamic Treatment Types (VMAT and DynamicIMRT) is inherently higher
compared to StepIMRT, due to the differences and limitations in segment
boundary determination and the associated IQM Signal allocation.
Clinically speaking, in most cases, the overall quality of a dynamic beam
delivery is comparable to that of a StepIMRT field. Therefore, the
enhanced Segment-by-Segment IQM Signal deviations, which are
observable individually, become less significant in their impact with the
increasing amount of signal accumulated over the course of an
increasing number of beam segments.
This phenomenon is mathematically inherent to Cumulative IQM Signals.

• For VMAT, a high gantry acceleration may occur during the start of beam
delivery, where the gantry speed increases from 0 to its maximum velocity
(commonly 6°/s) within a few beam segments. The movement accuracy
of the gantry decreases with increasing variations in its speed. Therefore,
the planned vs. actual gantry angles may not match as accurately during

IQM User Reference Manual (v1.35a SW-v1.8) 6-8


the start-up phase of an arc as during the remaining beam delivery,
where the gantry speed is steadier. As a result, the position of the segment
boundaries, as determined by the IQM System, may be less accurate
during the initial phase of an arc, and therefore the related IQM Signals
may show greater deviations from their reference.
This phenomenon affects both Cumulative and Per-Segment IQM Signals.

• Dynamic Treatment Types may inherit a high dose rate variation (e.g. from
0 to 600MU/min or more) within a relatively large portion of the first beam
segment (as compared to StepIMRT). As a result, the treatment machine
may overshoot or undershoot during this initial startup phase of the linear
accelerator which may lead to increased IQM Signal deviations.
This phenomenon affects both Cumulative and Per-Segment IQM Signals.

To address declining IQM Signal deviation uncertainty during the initial delivery
phase of dynamic treatment techniques, it is possible to set a tolerance corridor
which decreases monotonously with increasing segment numbers.

A series of values and integers may be used to define segment-specific ranges


and apply different Watch or Action Level deviation thresholds to the different
ranges. The value syntax is separated into one block per segment range
consisting of two items each. The first block item (odd positions 1, 3, 5, … in the
series) is a percent (%) deviation limit. The second block item (even positions 2,
4, 6, … in the series) designates the index (not segment number) of the last
segment to which the preceding limit applies. The final block in the series consists
of only a percent deviation limit which applies to the remaining segments.

Note: the segment indices that define ranges are further explained below the
following example.

Example for decreasing tolerance - VMAT:

Figure 85 shows a graphical representation of the following decreasing


Cumulative Watch rule set for a VMAT field with 10 beam segments:
VMAT.Watch.Cumulative = 12.0,1, 8.0,2, 6.0,4, 4.5

1st Block:
The “12.0” represents the % deviation limit for the first segment range:
±12.0%. The “1” is the index of the last segment to which ±12.0%
applies (segment index 1 = segment number 1, see “VMAT segment
indices” table below), thus the first range is only spanned by segment
number 1.
2 Block: The % deviation limit for the second segment range is ±8.0% and
nd

applies until segment number 2.

IQM User Reference Manual (v1.35a SW-v1.8) 6-9


3rd Block: The % deviation limit for the third segment range is ±6.0% and applies
until segment number 4.
4 Block: The % deviation limit for the final segment range is ±4.5% and applies
th

to the remainder of the field, since it is not limited by another segment


index (segment numbers 5 to 10).

Figure 85 – Graph labelling and values for Cumulative Rule Example - VMAT

If a series of criteria values are used, each % deviation limit value must be smaller
or equal than the preceding one, and each last segment index must be larger
than the preceding one, otherwise IQM Monitor will present an error at startup.

Note: How Segment indices as used in the Clinical Rules are defined
(background information)

Segment Index vs. Segment Number

Segment indices as used in the Clinical Rules are defined as follows:

For VMAT, the segment index starts with 1 and is incremented by 1 for each
segment in the graph. It corresponds to the segment number.

VMAT segment indices


Segment index 1 2 3 4 5 N
corresponds to 1 2 3 4 5 N
segment number

IQM User Reference Manual (v1.35a SW-v1.8) 6-10


For IMRT, the segment index starts with 1 and is typically incremented by 2 for
each segment where beam is delivered in the graph, so it does not
correspond to the segment number. The even-numbered segments are
“move-only” segments with no beam delivered, so they are not considered
in monitoring results.

IMRT segment indices


Segment index 1 2 3 4 5 N
corresponds to 1 3 5 7 9 2n – 1
segment number

Note: Assigning Segments to Ranges

Segment ranges defined for a particular rule are based on individual


segments, not on segment groups as in earlier versions of the IQM Monitoring
software. When a segment group includes segments in two (or more)
different ranges, their individual percent error values are averaged to yield
the percent error to be applied to the segment group.

Example for decreasing tolerance - StepIMRT:

A decreasing tolerance corridor for StepIMRT cases is rarely required in a clinical


environment. IQM Monitor enables the user to set a decreasing rule set for
StepIMRT fields using the same syntax as for VMAT.

The segment ranges would be assigned to different segment numbers, if the


same value series, as used in the previous example, was applied as a StepIMRT
rule:
StepIMRT.Watch.Cumulative = 12.0,1, 8.0,2, 6.0,4,
4.5

Figure 86 shows a graphical representation of the rule set above for a StepIMRT
field with 19 beam segments.

1st Block:
The % deviation limit for the first segment range is ±12.0% and applies
until segment number 2×1−1 = 1.
2 Block: The % deviation limit for the second segment range is ±8.0% and
nd

applies until segment number 2×2−1 = 3.


3 Block: The % deviation limit for the third segment range is ±6.0% and applies
rd

until segment number 2×4−1 = 7.

IQM User Reference Manual (v1.35a SW-v1.8) 6-11


4th Block: The % deviation limit for the final segment range is ±4.5% and applies
to the remainder of the field, since it is not limited by another segment
index (segment numbers 9 to 19).

Figure 86 – Graph labelling and values for Cumulative Rule Example – StepIMRT

Note: For VMAT or DynamicIMRT fields, a decreasing and eventually constant


Watch and Action level range is often defined. Typically, the constant range
begins between segment #10 and #60, meaning that for standard VMAT
with 90 segments, the level defined as constant is applied as pass criterion
for the ´Final Cumulative Deviation´ of the total field.

However, for fields where the last segment falls in the range of decreasing
levels, the level value which applies at the last segment will be applied as
the ´Final Cumulative Deviation´ pass criterion for the field on the whole. This
will be greater than the constant level of ±2.4 defined for segments after
segment #17, as there are no segments where this level comes into play,
unless a “Short Rule" (see 6.1.2.5) is set to overrule this effect.
Example:
VMAT.Watch.Cumulative = 47.5,1, 23.2,2, 15.2,3, 11.3,4, 9.0,5, 7.4,6,
6.3,7, 5.5,8, 4.9,9, 4.4,10, 4.0,11, 3.6,12, 3.3,13, 3.1,14, 2.9,15, 2.7,16,
2.5,17, 2.4
The decreasing Watch Level range ends at segment #17 and continues with
a pass criterion of ±2.4%. This means that for a VMAT field with more than 17

IQM User Reference Manual (v1.35a SW-v1.8) 6-12


segments IQM applies a pass criterion of ±2.4% to the Final Cumulative
Deviation, while for a "short" VMAT field, a larger value will be applied:

In this example, for a field with 13 segments, the Final Cumulative Deviation
would be 3.3%. The values defined in the rule for segments after #13 would
not come into play, including the constant level of ±2.4%.

6.1.2.3 Asymmetric Tolerance Corridors


For dynamic Treatment Types, where greater Per Segment IQM Signal
uncertainties may occur (see section 6.1.1.1), the frequency distribution of IQM
Signal deviations may be asymmetrical, indicating that positive % deviations
tend to be greater than negative ones.

The measured IQM Signal is always greater than 0, which means that
theoretically, the maximum possible negative % deviation is −100%, if the
measured IQM Signal is equal to 0. On the other hand, for positive IQM Signal
deviations, there is no theoretical limitation and deviations larger than +100%
may occur. This effect is pertinent during the start-up phase of the beam, where
MU over and undershooting may be present due to high dose rate variations,
leading to increased IQM Signal deviations, as described in section 6.1.2.2. An
overshoot usually leads to a more positive signal deviation (>100%) as compared
to an undershoot (≤−100%) which makes the related frequency distribution of
deviations asymmetrical. If a symmetrical tolerance corridor is specified, this
effect may lead to an increased number of positive IQM Signal deviations for
the initial segments of beam delivery resulting in undesired Caution or Alarm
messages. IQM allows Action and Watch Levels to be asymmetrically
decreasing, since the described effect may neither be clinically relevant to the
patient (Action Level), nor be desired to be highlighted as a significantly
measurable deviation from reference (Watch Level).

Figure 87 shows the comparison of a symmetric vs. an asymmetric Cumulative


Watch Level as determined based on the same VMAT data. Applying the 2.5-
fold standard deviation, the negative and positive IQM Signal deviations were
considered separately for the asymmetric corridor (solid lines), whereas for the
symmetric tolerance (dashed lines) all deviations were evaluated as a whole.
Both tolerances level off at the same constant value of ±2.5%.

IQM User Reference Manual (v1.35a SW-v1.8) 6-13


Figure 87 – Comparison of a symmetrical vs an asymmetrical Cumulative VMAT Watch Level as
determined for the same data based on the 2.5-fold standard deviation of IQM Signal
deviations.

In contrast to the constant Watch Level, the constant Action Level may be set
to asymmetrical values. The Action Level is employed to highlight clinically
relevant IQM Signal deviations and may be derived by correlating the IQM
Signal with respective variations in the planned dose distribution. Clinically
speaking, an underdosing has a negative effect on the planning target volume,
whereas an overdosing might increase the late toxicity risk of the involved organs
at risk. The Action Level may be set asymmetrically, since the different dosimetric
effects of different regions of interest may require the positive “overdose” Action
Level to be set independently from the negative “underdose” Action Level.

Example for asymmetrically decreasing tolerance – VMAT:

To set an asymmetric tolerance, the first item for each segment range block is
separated into a bracketed value-tuple where the first value represents the
positive and the second represents the negative % deviation limit:
VMAT.Watch.Cumulative =
= (14.0,-8.0),1, (10.0,-5.0),2, (6.0,-3.0),4, 3.0

Figure 88 shows a graphical representation of the Watch level rule set above for
a VMAT field with 10 beam segments.

1st Block:
The % deviation limit for the first segment range is +14.0% and −8.0%
and applies to segment number 1.
2 Block: The % deviation limit for the second segment range is 10.0% and
nd

−5.0% and applies until segment number 2.

IQM User Reference Manual (v1.35a SW-v1.8) 6-14


3rd Block: The % deviation limit for the third segment range is +6.0% and −3.0%
and applies until segment number 4.
4 Block: The % deviation limit for the final segment range is ±3.0% and applies
th

to the remainder of the field, since it is not limited by another segment


index (segment numbers 5 to 10).

As an additional option, the Action Level can be set such that the constant part
of the corridor is asymmetric:

VMAT.Action.Cumulative =
= (14.0,-10.0),3, (10.0,-8.0),4, 8.0,5, (6.0,-8.0)

Figure 88 shows a graphical representation of the Action level rule set above for
a VMAT field with 10 beam segments.

1st Block: The % deviation limit for the first segment range is +14.0% and −10.0%
and applies until segment number 3.
2nd Block: The % deviation limit for the second segment range is +10.0% and
−8.0% and applies until segment number 4.
3 Block: The % deviation limit for the third segment range is ±8.0% and applies
rd

until segment number 5.


4 Block: The % deviation limit for the final segment range is +6.0% and −8.0%
th

and applies to the remainder of the field, since it is not limited by


another segment index (segment numbers 6 to 10).

IQM User Reference Manual (v1.35a SW-v1.8) 6-15


Figure 88 – Graph labelling and values for asymmetric Cumulative Rule Example – VMAT

6.1.2.4 NA Rule
The start-up effects described above can be observed for the initial 1 to 3 beam
segments of highly modulated dynamic beam deliveries. Such start-up effects
may potentially "stack up" on each other and induce IQM Signal deviations
which may be too large for meaningful evaluation. IQM provides an option to
set a Watch and/or Action Level that starts after a selectable initial segment
range to which no Levels are applied. The underlying large IQM Signal deviations
can therefore no longer induce false, misleading or undesired Caution or Alarm
messages.

Example for NA Rule – VMAT:

To apply no Levels to the initial segment range, the referring % deviation value
in the first block can be set to “NA”:
VMAT.Watch.Cumulative = <same as for previous example>
VMAT.Action.Cumulative =
= NA,2, (14.0,-10.0),3, (10.0,-8.0),4, 8.0,5, (6.0,-8.0)

Figure 89 shows a graphical representation of the rule set above for a VMAT field
with 10 beam segments.

IQM User Reference Manual (v1.35a SW-v1.8) 6-16


1st Block:
The % deviation limit for the first segment range is NA and therefore
no Action Level is applied up to and including segment number 2.
2 to 4 : Same as in previous example.
nd th

Figure 89 – Graph labelling and values for asymmetric Cumulative Rule Example with NA Rule –
VMAT. The corridor for Action level deviations is applied only after the first 2 segments.

6.1.2.5 Short Rule


In a clinical environment, a Cumulative VMAT Watch Level may be defined as
decreasing until the (for example) 30th segment, reflecting the IQM Signal
deviation uncertainty for full VMAT arcs with e.g. 90 beam segments per field.
However, some departments also employ conformal arcs or butterfly arcs, which
are VMAT beams ranging across a shorter gantry angle span per field. As
compared to full arcs, these “Short VMAT” beams typically include a higher
amount of MU per beam segment. In addition, their modulation complexity (as
defined by e.g. gantry acceleration, dose rate variation and the amount of leaf
travel) may be lower compared to full VMAT arcs. This decrease in complexity
may reduce the IQM Signal deviation uncertainty and allow the user to set a
tighter tolerance corridor in the form of a “Short Rule".

IQM User Reference Manual (v1.35a SW-v1.8) 6-17


The optional [“Short”] part may be added as a suffix to form a separate Clinical
Rule for the same Treatment Type, Reference Type, Level and Criterion Type. The
Short Rule is only applied if the number of segments of the Treatment Field (“short
beam”) is smaller than the number of segments that are involved in the
decreasing part of the relevant Clinical Rule without the [Short] part. The Short
Rule value reflects the % deviation tolerance that is applied to the final signal of
a short-beam and can only be a single value.

Example for Short Rule – VMAT (same as for previous example; only the Short Rule
was added):
VMAT.Watch.Cumulative =
= (14.0,-8.0),1, (10.0,-5.0),2, (6.0,-3.0),4, 3.0

VMAT.Watch.Cumulative.Short = 2.0

VMAT.Action.Cumulative =
= NA,2, (14.0,-10.0),3, (10.0,-8.0),4, 8.0,5, (6.0,-8.0)

Figure 90 shows a graphical representation of the rule set above for a VMAT field
with 4 beam segments. The solid and dashed lines indicate the tolerance
corridors as they are applied with and without the set Short Rule Short = 2.0,
respectively. The defined corridors are asymmetrical, as in the previous example.

Watch Level:

The outlined Cumulative Watch Level decreases until segment number 5 and
assigns a % deviation value of +6.0% and −3.0% to the fourth segment (and ±3.0
for all segments beyond the 4th, but there aren't any). However, since the VMAT
field in question has fewer than 5 segments and therefore the Cumulative Watch
Short Rule is applicable, the final VMAT segment (number 4) will be evaluated
based on a % deviation value of ±2.0%, as defined with Short = 2.0.

Action Level:

The Cumulative Action Level does not have a Short Rule assigned, and the final
VMAT segment (number 4) is therefore evaluated based on a % deviation value
of +10.0% and −8.0%. The corridor (6.0,-8.0) never comes into play.

IQM User Reference Manual (v1.35a SW-v1.8) 6-18


Figure 90 – Graph labelling and values for the Short Rule Example – VMAT (with 4 segments)
The solid and dashed lines accord to the corridors as they would be applied with and without
the Short Rule, respectively.

6.1.3 Setting Clinical Rules


During or after initial installation, extensive measurement data are acquired
based on typical treatment plans to determine appropriate Clinical Rules
settings empirically for each linear accelerator equipped with an IQM Detector.
Contact Support as needed for assistance in planning, implementing or
updating Clinical Rules.

IQM User Reference Manual (v1.35a SW-v1.8) 6-19


6.1.4 Clinical Rules Effect on Monitor Application Display
If no rule is in effect for a treatment type (VMAT or IMRT) and criterion type
(PerSegment or Cumulative), such as for the Segment-by-Segment graph when
VMAT fields are delivered, the Reference Signal Record appears as a single line.
The “Watch Level” and “Action Level” labels state “n/a”.

Figure 91 – Segment-by-Segment graph with no Clinical Rule in effect. The Reference Signal
Record values for each segment define the green reference line.

If a Watch level rule is in effect, a green corridor will appear. This green corridor
covers the Reference Signal Record values for each segment, plus and minus
the Watch level values for the treatment and criterion type. The “Watch Level”
label states the range value defined in the rules, in this example “±5%”.

Figure 92 – Segment-by-Segment graph with Watch level rule set to ±5%.


Any segment signal value outside the green corridor is in the Watch range.

Any segment signal value within the green corridor is considered within the
normal, expected signal variation. Any segment signal value beyond the green
corridor will be registered as a Watch level deviation.

IQM User Reference Manual (v1.35a SW-v1.8) 6-20


If an Action level rule is in effect, a red dotted line will appear. This corridor covers
the Reference signal values for each segment, plus or minus the Action level
value. Any segment value beyond the red dotted corridor will trigger a signal
deviation Clinical Alarm.

Figure 93 - Segment-by-Segment graph with Action level rule. Any segment value beyond the red
dotted line is in the Action range and triggers a Clinical Alarm.

Tolerance levels with multiple segment ranges


When a Watch or Action rule has multiple segment ranges with different
tolerance values, only the first tolerance value and the final / constant tolerance
value are labeled. The beginning of each of these ranges are indicated with a
full (top and bottom) tick on the Watch or Action line. All other tolerance value
changes are indicated with a half tick below the line.

Figure 94 - Only the first tolerance level and the final, constant level are labeled with numerical %
values. Other level changes are indicated with half ticks below the Watch or Action line

6.1.5 Verifying that Clinical Rules are Applied Correctly


To verify that the Clinical Rules have been configured correctly and are applied
as intended, start the IQM Monitor application and consecutively deliver several
fields which are considered suitable to verify the changed settings. Depending
on the treatment techniques typically used at a site, at least one
VMAT/RapidArc plan and one Step-and-Shoot IMRT plan should be run to check
the Clinical Rules implemented.

IQM User Reference Manual (v1.35a SW-v1.8) 6-21


Check for configuration error messages while IQM Monitor starts. Syntax errors or
invalid values in the configuration file result in error messages that indicate what
type of mistake is causing the error message. If an error message is presented,
return to the configuration file and correct the error, then restart Monitor.

Once Monitor has started normally, inspect the screen contents. The Segment-
by-Segment and Cumulative graph displays should now be labeled with the
intended Watch level and Action level values.

6.2 Segment Merging and Smoothing Rules (in Configuration


Settings)
All settings described in this section are specified in the [Rules] section of the
IQM.Config.ini file.

6.2.1 Mandatory Segment Grouping (Merging)


Three situations require planned segments to be merged for evaluation by the
IQM Monitor application:

• Blind Arc Merging


• Multi-Arc Turnaround Points
• Move-only segments

The signal collected during delivery of the segments belonging to a mandatory


group are summed and split evenly between the member segments. This
averaged signal value is saved in the database as the segment signal.

These segment groupings are always applied before any optional merging or
averaging rules are applied.

IQM User Reference Manual (v1.35a SW-v1.8) 6-22


6.2.1.1 Blind Arc Merge Rule (Merge.BlindArc) – VMAT only
At the very top of the gantry, in the vicinity of 0/360 degrees, and at the very
bottom, around 180 degrees, technical characteristics of the IQM inclinometer
prevent the Monitor software from pinpointing the gantry angle with the same
precision that applies to the rest of the gantry arc.

In IQM, these two gantry angle ranges are called “blind arc” regions. IQM
cannot reliably assign Signal Counts to individual segments that are inside or that
overlap part of the “blind arc” regions.

Blind Arc Region


from -2° to 2°

Figure 95 Blind Arc region

To address this limitation, the measured IQM signal of all segments within a
specified range from the 0º/360º and 180º gantry positions are accumulated and
then evenly distributed between the involved segments. The segments in the
blind arc region are always merged into one segment group for the purpose of
comparison against the Reference. This allows a conclusive comparison of
reproducible reference versus actual signal values over many fractions or days.

For comparison in Monitor, the Blind Arc segments are presented in the data
tables as a group, on one line, labeled with the group’s first and last segment
numbers (e.g. N – Q).

The blind arc region is determined by the BlindHalfArc value in the


[SystemLimits] section, by default -2° – +2° (for information about the
BlindHalfArc parameter see section 6.4.3 [SystemLimits] Section (IQM
Workstation only)).

6.2.1.2 Multi-Arc Turnaround Points


When a planned field includes multiple overlapping arcs, the specific angles at
which the gantry changes direction are called Turnaround Points. When the
gantry is reversing direction, there will be a segment where the gantry finishes
the first arc and then a segment in which it begins the second arc. However,
IQM cannot distinguish the end of the first arc from the start of the second, as
the two segments share a gantry span.

IQM User Reference Manual (v1.35a SW-v1.8) 6-23


Therefore the first arc´s last segment and the second arc´s final segment are
merged into a segment group for evaluation. Any neighboring segment that
overlaps either the final or first segment span will also be included in the group.

a. b.
26 26
27 27
29
29 28
28

Figure 96 - Turnaround Point Merging: in example (a), Segments 27-28 will be grouped.
In example (b) the segment angle spans on the second arc are larger than on the first.
Segment 26-28 form the turnaround group because 26 partially overlaps Segment 28.

6.2.1.3 Move-only Segments


Treatment planning systems sometimes place control points without 'beam on´
in the middle of Dynamic IMRT or VMAT fields. This can occur when the gantry
rotates past an organ at risk in a VMAT field or when the MLC leaves shift from
one lesion to another in a Dynamic IMRT field.

The IQM Monitor Application usually only displays ticks and data points for
segments with 'beam on', but move-only segments in the middle of a dynamic
field can disrupt the pattern of showing segments. Grouping the segments
simplifies signal processing and allows for visually consistent graph displays.

6.2.2 Optional Merge Rules and Running Average Smoothing


Beyond the mandatory merging done in the cases of the blind arc, multi-arc
turnaround points and move-only segments, the IQM Monitor application offers
optional merge rules to assist users in achieving meaningful signal comparisons.

These optional groupings are applied later in the evaluation process and do not
affect the signal saved in the database for each segment. Each segment in the
group has its individual measured signal saved in the database. This means that
different optional grouping rules may be applied later, in Review or for reports.

The VMAT.Merge.MinSpan rule specifies the minimum gantry span (in


degrees) for a VMAT segment NOT to be merged with the next segment.

The VMAT/DynamicIMRT.Merge.MinMU rule specifies the minimum planned


Monitor Units for a VMAT or DynamicIMRT segment NOT to be merged with the
next segment.

IQM User Reference Manual (v1.35a SW-v1.8) 6-24


This means that consecutive segments are merged until the gantry span and
Monitor Units of the formed segment group are greater than or equal to the
specified Merge Rule values.

Recommended settings:
VMAT.Merge.MinSpan = 1.0
VMAT.Merge.MinMU = 1.0
DynamicIMRT.Merge.MinMU = 3.0
Any segment in which the gantry rotates less than this minimum span will be
merged to a segment group. In addition, any segment in which the planned
Monitor Units are less than the minimum MU value will be merged to a segment
group. This means that the signal counts for all segments within one segment
group will be summed during monitoring.

Another available, optional, rule is the VMAT/DynamicIMRT.RunAvg rule.


Although not recommended by default, the Running Average rule is available
for the case that too many false alarms occur due to signal variation in
VMAT/RapidArc deliveries, to smooth the signal curve. The rule only applies to
Type VMAT and DynamicIMRT fields.

Consult iRT Support for advice for implementing this parameter.


VMAT.RunAvg.Mode = running average mode, one of “None”
or “SimpleCenteredExt”.
VMAT.RunAvg.Count = number of segments used to average
the signal values, does not apply if Mode is “None”;
must be an odd integer equal to three or more.
The running average (RunAvg) rules define whether the IQM signal is processed
using the running average smoothing algorithm before evaluation and display
of alerts in the IQM Monitor application.

If the mode is SimpleCenteredExt, the segment plot shows a running


average graph. In this mode, every original segment signal value is replaced by
the mean of the signal values of the n=(Count-1)/2 previous and subsequent
segment signal values, and the original signal value. Count must be an odd
integer equal to three or more. The first and last segment groups have signal
values that are the mean of the available segment values. For instance, if the
Count is 3, the first segment’s signal value is the average of the first and second
segment group signal values.

If mode is None or undefined, then the segment plot shows an unprocessed


segment-by-segment graph.

IQM User Reference Manual (v1.35a SW-v1.8) 6-25


Example for MinSpan, MinMU and RunAvg Rules – VMAT (PerSegment):

The following Configuration Rules:


VMAT.Merge.MinSpan = 2.5
VMAT.Merge.MinMU = 5.0
VMAT.RunAvg.Mode = SimpleCenteredExt
VMAT.RunAvg.Count = 3
shall be applied to the VMAT segments as defined in the left part of Figure 97:

Figure 97 – Example of a VMAT field with 10 beam segments. Each segment has a specific gantry
span, Monitor Unit value and IQM Signal. The columns to the right of the vertical separator include
the properties of the segment groups formed by applying the example Configuration Rules as
specified above. The related signal graphs are illustrated in Figure 98.

The segment properties to the left are given as an example. The properties of
the segment groups to the right are formed by applying the example
Configuration Rules as specified above. The MinSpan and MinMU Merge Rules
are applied before the RunAvg Rule. Figure 98 shows a graphical representation
of the IQM Signal courses with

(i) no Configuration Rules applied (blue line)


(ii) the specified Merge Rules applied (yellow line)
(iii) the specified Merge and RunAvg Rules applied (black line)

Applying the MinSpan and MinMU Rules:

Segments 1 – 2: The first segment has a gantry span of 2°, which is lower than the
MinSpan value of 2.5°. The first segment is therefore merged with its successor
forming a segment group spanning across 2°+2°=4°>2.5° and including
6MU+6MU=12MU>5.0MU. The formed segment group fulfills both merge rule
values and is therefore not merged with further segments. The relating IQM Signal
is 17+15=32.

IQM User Reference Manual (v1.35a SW-v1.8) 6-26


Segments 3 – 5: The third segment will be merged to its successor, since neither
its gantry span (2°<2.5°), nor its Monitor Units (2MU<5MU) exceed the MinSpan
and MinMU values, respectively. The formed segment group would have a
gantry span of 2°+2°=4° which would satisfy the MinSpan Rule, although the
relating Monitor Units of 2MU+2MU=4MU would fall below the MinMU value.
Segments 3 and 4 are therefore further merged with segment 5 to form a
segment group which fulfills both Merge Rules: 2°+2°+3°=7°>2.5° and
2MU+2MU+4MU=8MU>5MU. The relating IQM Signal is 10+15+5=30.

Segments 6 – 7: The sixth segment will be merged to its successor because its
Monitor Units (4MU<5MU) do not exceed the MinMU value. The formed segment
group has a gantry span of 3°+3°=6°>2.5° and a MU value of
4MU+6MU=10MU>5MU fulfilling both rule values. The relating IQM Signal is
14+8=22.

Segments 8, 9 and 10: These segments have all a gantry span of 3°>2.5° and
6MU>5MU and are therefore not merged with any other segments. The relating
segment groups include one segment each and the relating IQM Signals stay as
they are.

Applying the RunAvg Rule:

The VMAT.RunAvg.Count of 3 indicates that the IQM Signal of a given segment


is calculated by the average of its signal value and first predecessor and
successor:

Segment Group 1: The first segment group does not have a predecessor.
Therefore, only the IQM Signal of its first successor and itself is averaged. The
RunAvg’ed IQM Signal for the first segment group is therefore (32+30)/2=31.

Segment Group 2: The IQM Signals of segment groups 1 – 3 are averaged to


determine the smoothed IQM Signal of the second segment group:
(32+30+22)/3=28.

Segment Group 3: The IQM Signals of segment groups 2 – 4 are averaged to


determine the smoothed IQM Signal of the third segment group:
(30+22+35)/3=29.

Segment Group 4: The IQM Signals of segment groups 3 – 5 are averaged to


determine the smoothed IQM Signal of the fourth segment group:
(22+35+60)/3=39.

Segment Group 5: The IQM Signals of segment groups 4 – 6 are averaged to


determine the smoothed IQM Signal of the fifth segment group:
(35+60+40)/3=45.

IQM User Reference Manual (v1.35a SW-v1.8) 6-27


Segment Group 6: The sixth segment group does not have a successor.
Therefore, its smoothed IQM Signal is calculated by averaging segment groups
5 and 6: (60+40)/2=50.

Figure 98 – Graphical representation of the different stages of applying the example Merge and
RunAvg Configuration Rules to the segments as outlined in Figure 97.

This example illustrates merging and averaging for PerSegment signals. For
Cumulative signals, the Merge Rules are applied the same way i.e. the IQM
Signal graphs will include the same segment groups for both criterion Types.

Note that the RunAvg rule is not directly applied to Cumulative signals. Instead,
the Cumulative signals are calculated from the smoothed PerSegment signals.
In the example above, the Cumulative IQM Signal for segment group 3 would
be calculated by the sum of the smoothed PerSegment signals from segment
group 1 to 3: 31+28+29=88.

6.2.3 Effect of Merge Rules on Clinical Rules


If the segments in a segment group cover multiple segment ranges, as defined
in the tolerance corridor, the % deviation values of each individual segment in
the group are averaged to yield a single deviation level that is applied to the
group. If any segment in the group falls inside an NA-segment-range, the
segment group’s % deviation value will be “NA”.

Example Merge Rules & Clinical Rules – VMAT:

The example from section 6.1.2.4 is modified such that the Action Level NA Rule

IQM User Reference Manual (v1.35a SW-v1.8) 6-28


is extended to the first 3 beam segments:
VMAT.Watch.Cumulative =
= (14.0,-8.0),1, (10.0,-5.0),2, (6.0,-3.0),4, 3.0

VMAT.Action.Cumulative =
= NA,3, (10.0,-8.0),4, 8.0,5, (6.0,-8.0)

Figure 99 lists the resulting Watch and Action Level values for each beam
segment to the left of the vertical separator. The Watch and Action Level values
for the segment groups (same merging applied as in section 6.2.2) are listed to
the right of the separator and can be derived as described below.

Figure 99 – Tabular representation of the values for the Merge Rules & Clinical Rules example –
VMAT. The values to the right of the vertical separator apply to the segment groups as merged in
the previous example and can be derived by averaging the values to the left.

Segment Group 1: The first segment group consists of the first two segments. The
relating Watch Level is (14%+10%)/2=+12% and (−8%−5%)/2=−6.5%, whereas the
Action Level is NA, since both segments are assigned to a NA Rule.

Segment Group 2: The second segment group consists of segments 3 to 5. The


relating Watch Level is (6%+6%+3%)/3=5% and (−3%−3%−3%)/3=−3%, whereas
the Action Level is NA, since the first segment in this group (segment 3) includes
an NA Rule.

Segment Groups 3 – 6: All segments of the remaining segment groups fall into
the same segment ranges per group. The tolerance levels for the segment
groups are therefore the same as for the relating segments.

As illustrated in Figure 100, the tolerance values per segment group (solid lines)
represent an approximation (interpolation) of the values per segment (dashed
lines).

IQM User Reference Manual (v1.35a SW-v1.8) 6-29


Figure 100 – Graph labelling and values for the Merge Rules & Clinical Rules example – VMAT. The
segment groups are highlighted by the larger circles. The tolerance values for the segment groups
(solid lines) are linearly interpolated by averaging the involved values per segment (dashed lines).

6.2.4 FIR Gantry Angle Filtering


During VMAT beam delivery, the Linac control system adjusts the gantry velocity,
along with the dose rate and MLC leaf and jaw positions, to deliver a predefined
dose in each segment. The variations in gantry velocity can create mechanical
vibrations throughout the Linac. IQM supports a digital, software-based “FIR”
(finite impulse response) filter, which reduces the vibrational noise to the
accelerometer’s total signal. If vibrations are affecting the accuracy of IQM’s
assessment of gantry angle, it is recommended to consider use of the optional
FIR filter setting. The FIR filter is described in 6.4.3 [SystemLimits] Section (IQM
Workstation only).

Note: FIR Filtering will not generally improve results for VMAT arcs that start in a
blind arc region, near 0˚ and ±180˚.

6.2.5 Background Signal (Dynamic Leakage) Handling


Background signal is the activity measured by the IQM Detector when the beam
is off. It is the combined result of electrometer leakage currents and background
radiation, such as cosmic rays penetrating the detector. For some detectors, the
leakage is humidity-dependent, which causes a diverging influence on the IQM
Signal with varying geographical location and climatic conditions. When

IQM User Reference Manual (v1.35a SW-v1.8) 6-30


humidity-based leakage is very low, leakage from one channel to the other
(crosstalk between channels) becomes the primary background signal.
Background signal is usually positive but can also be negative.

The maximum tolerable background signal value for the IQM Detector is ±1000
Signal Counts/min. On average, the background signal ranges between 0 and
500 Signal Counts/min.

Monitor offers a mode in which the current background signal is identified and
subtracted from all poll values included in a treatment record. When this mode
is activated, Monitor constantly re-measures the current background in between
field deliveries, when no significant signal is expected to occur.

When this mode is enabled the background signal value applied to a field is
displayed in the status block at the bottom left of the Monitor application.

Configuration of this mode is described in section 6.4.1.3.5 Settings for Dynamic


Background Signal Handling.

6.2.5.1 Effect on measurement signal


Activating the dynamic Background Signal handling mode has an impact on
the measured signal: its uncertainty decreases, i.e. on average, long-term and
short-term signal stability increases. Comparing measurement results where
background signal correction was enabled versus measurements of the same
beam where correction was disabled may result in higher deviations than when
comparing measurement results where the mode was the same.

6.2.5.2 Advice for enabling Dynamic Background Signal Handling


Due to the previously described effect on the measurement signal, the following
recommendations are provided for enabling Dynamic Background Signal
Handling:

IQM User Reference Manual (v1.35a SW-v1.8) 6-31


For fraction QA, if previous sessions have been recorded without background
signal correction enabled, the calculated reference should be set (again) as the
baseline for further treatment verification, rather than comparing new treat
records with background correction to an un-corrected measured reference.
This can be done by the site’s Responsible User using IQM Review. Alternatively,
a new measured reference may be recorded, reviewed, and set as the new
baseline for constancy checks in further treatment sessions.

6.2.5.3 Recommendations for the Workflow


As described before, the Monitor software measures and determines the
background signal correction offset before each field begins. With the default
configuration settings, this requires Monitor to be started up and connected to
the detector and the Linac - without a treatment field being loaded -– for at
least 7 seconds before a background signal correction value is available. If the
time elapsed between establishing the connection and loading the first field is
shorter, background signal correction will not be applied when monitoring and
recording the field, which may lead to high deviations, if leakage is high during
treatment.

6.3 Treatment Planning Considerations for IQM


The effect of the presence of the detector in the beam must be reviewed and
the clinical significance of the effect assessed by the user and taken into
consideration in treatment planning as required.

6.3.1 Implementing IQM Beam Attenuation in Treatment Planning


The IQM Detector is installed in the beam path and causes a beam attenuation
for which the effect on dose must be taken into consideration. The user institution
is responsible for the correct implementation of the beam attenuation in
treatment planning.

Evaluation of the type and method of correction required depends on the linear
accelerator, the treatment planning system, method of treatment and the
radiation therapy department’s own criteria and policies. Evaluation and

IQM User Reference Manual (v1.35a SW-v1.8) 6-32


implementation of the correction for beam attenuation is the responsibility of
medical physicist and outside the scope of the IQM.

Warning:
The IQM Detector causes a beam attenuation whose effect on
dose must be taken into consideration.
The user must review the effect of the presence of the detector
in the beam, assess the clinical significance of the effect, and
take the effect into consideration in treatment planning if
required.
Failure to take the beam attenuation caused by the detector
into consideration in the treatment plan may result in
mistreatment, which may result in minor or major side effects,
including death.

The user, typically the responsible medical physicist, shall measure depth dose
and profile measurements for the photon energies to be used with the IQM in
place and compare these measurements to the depth dose and profile
characteristics measured without IQM in place and evaluate the effects of the
beam attenuation.

The attenuation due to the detector will be approximately 4.5% (for 15MV) or
5.5% (for 6MV) depending on the treatment machine, energy and measurement
setup. Note: these approximate values are NOT to be used as default values but
rather are provided to underscore that the detector has an effect on the beam
and to emphasize the importance of taking measurements to characterize the
beam accurately.

When using non-standard SADs/SSDs, other factors may impact beam


characterization with IQM as well. The user is cautioned to evaluate non-
standard SADs/SSDs separately.

The responsible user determines how to incorporate the beam into the treatment
planning system (TPS). Depending on the beam characteristics observed and
the TPS, the beam attenuation may be accounted for by various methods
including:

• acquisition of TPS beam data with the IQM Detector in place


• adjustment of the beam data with factors based on the depth dose and
profile measurements taken with the detector in place
• implementation of a correction factor, such as a tray factor
• other methods chosen by the user

Particular treatment techniques may require additional considerations and/or


measurements. The beam delivered through the detector as used in Total Body

IQM User Reference Manual (v1.35a SW-v1.8) 6-33


Irradiation (TBI) may have different characteristics which require different
modeling in the TPS than as implemented for standard SSDs. Treatments at
shortened SSDs should be evaluated to determine if the change in SSD affects
the skin dose in a clinically significant way and whether a separate modelling in
the TPS is required. Evaluation and implementation of appropriate methods for
taking into account the effect of the detector on the beam is the responsibility
of medical physicist and outside the scope of the IQM.

IRT cannot make a recommendation concerning the suitability of methods for a


particular combination of linear accelerator and treatment planning system
(TPS). It is the responsibility of the user to determine the appropriate method and
implement the correction for the beam attenuation and any other effect on the
beam in accordance with his or her professional judgement and department
policies.

6.3.2 Correcting for the Absence of the IQM Detector


Once the detector’s beam attenuation has been implemented in the TPS and
the dose corrected for the presence of the IQM Detector, delivering these plans
without the detector in place would result in an incorrect dose delivery. Coding
in the IQM Mount accessory allows the Linac to recognize whether the IQM
Detector is present or not. Therefore, the Linac control system should not allow
treatment if the plan has been made with IQM in place and the IQM has been
removed. The designated responsible user should inform the staff how to
proceed in this situation.

Warning:
If a treatment field was planned for delivery with the IQM
Detector in place, and the IQM Detector is NOT in place, the
user must account for its absence by:
Re-planning the treatment without the IQM Detector in the
beam model
OR
Using the IQM Service Attenuator (dummy) as described in
sections 8.6 and 8.7, and treating with the dummy in place.

If the detector is removed from the beam path for some reason, the user must
take action to ensure that the correct dose is delivered although the detector is
not present in the beam, either by re-planning the treatment plan or by using
the IQM Service Attenuator (dummy). Only then 1) will the delivered dose match
the planned dose and 2) should the Linac allow the treatment to be delivered,
as the accessory code is or is not present as called for in the delivered plan.

IQM User Reference Manual (v1.35a SW-v1.8) 6-34


If the treatment plan is re-planned, the IQM Mount accessory flag or setting in
the plan must also be removed so that the Linac control system permits the
corrected plan to be delivered without the IQM present. If the treatment plan is
not changed, then the IQM Service Dummy is affixed to the IQM Mount in place
of the detector.

Please see sections 8.6 Removing the IQM Detector for Service and 8.7 Using the
IQM Service Dummy for more information.

6.3.3 DICOM File Attributes


IQM Calc reads the following keywords (or tags) from DICOM-RT Plan files. This
tag reference is provided to assist users in investigating errors that prevent
DICOM-RT Plan files from being imported successfully.

Unless otherwise specified, all attributes are mandatory. If a plan does not
include all required values from mandatory attributes, the plan will not be
imported. IQM Calc moves the DICOM-RT Plan file to a “Failed Imports” folder
(to prevent IQM Calc from attempting to import it over and over) and logs the
error that prevented the file from importing.

Table 7 - Dicom-RT Plan Tags Required by IQM

(“>” represents hierarchy)

Attribute Name Tag Description


Patient ID (0010,0020) Primary identification code for the patient.
PatientsName (0010,0010) Patient’s name
(optional)
PatientsBirthDate (0010,0030) Patient’s date of birth
(optional)
RTPlanLabel (300A,0002) Plan ID
(optional)
Fraction Group (300A,0070) Introduces sequence of fraction groups.
Sequence Must have a length of at least 1.
>Referenced Beam (300C,0004) Introduces sequence of treatment beams in
Sequence current fraction group.
Note: Entries that do not have a BeamMeterset
tag are ignored (they are valid parts of the
DICOM file, but not parts of importable plan
data, e.g. kV images / CT pictures)
>>Referenced Beam (300C,0006) Uniquely identifies the beam.
Number Note: The Beam Numbers must be unique.

IQM User Reference Manual (v1.35a SW-v1.8) 6-35


Attribute Name Tag Description
>>Beam Meterset (300A,0086) MU to be delivered for the beam.
(conditional) Note: If the tag exists, the value is mandatory.
When the tag does not exist, the entry is ignored
(see 300C,0004).

Beam Sequence (300A,00B0) Introduces sequence of treatment beams.


>Beam Number (300A,00C0) Uniquely identifies beam.
Each “Beam Number” (300A,00C0) must match
a corresponding “Referenced Beam Number”
(300C,0006), and vice versa (except those
ignored because they have no
meterset=assigned MU). The entries can be in
any order.
>Beam Name (300A,00C2) Name (id) of beam.
Note: Beam Name (300A,00C2) is referred to as
the Field ID in IQM software.
This tag is required by IQM: it must exist and must
not be empty.
>Beam Description (300A,00C3) Description of beam.
(optional) Note: Beam Description (300A,00C3) is referred
to as the field description in IQM software. It is
optional. If the attribute is omitted and the
machine type is Varian, then the private
SecondaryBeamName attribute (3243,1009) is
also checked.
>Radiation Type (300A,00C6) Radiation Type. Must be PHOTON for all fields in
the Plan.
If empty, it is assumed that type is NOT PHOTON,
i.e. the field shall be rejected.
>Manufacturer (0008,0070) Machine manufacturer name.
(optional) Relevant only on BeamSequence level (not on
root/plan level).
Note:
If Manufacturer (0008,0070) is equal to or
contains the substring “Elekta”, the machine
type is Elekta. In this case, if the machine
configuration file doesn’t match, the field is
rejected from import.
If it is equal to or contains the substring “Varian”,
the machine type is Varian. In this case, if the
machine configuration file doesn’t match, the
field is rejected from import.
Otherwise the machine type is of other type.
Then the field is not rejected from import.
All string comparisons are case insensitive.
>Treatment Machine (300A,00B2) Treatment machine name.
Name

IQM User Reference Manual (v1.35a SW-v1.8) 6-36


Attribute Name Tag Description
>Primary Dosimeter (300A,00B3) Measurement unit of machine dosimeter.
Unit Note: Although not a mandatory DICOM tag per
all linac manufacturer specifications (e.g.
Varian), the Primary Dosimeter Unit (300A,00B3) is
required by IQM and must be “MU”.
>Final Cumulative (300A,010E) Proportional Value representing the complete
Meterset Weight intended MU to be delivered for this beam. Used
in connection with Cumulative Meterset Weight
to apportion MU to individual segments.
>Primary Fluence (3002,0050) Sequence defining whether treatment beam is
Mode Sequence standard or non-standard.
(optional) Note: Primary Fluence Mode Sequence
(3002,0050) is optional.
>>Fluence Mode (3002,0051) Treatment beam fluence type. May be
(optional) “STANDARD” or “NON_STANDARD”. IQM only
accepts NON_STANDARD if Fluence Mode ID
(3002,0052) is FFF and there is an FFF energy
defined in the IQM Machine File for the planned
Linac. Any other Fluence Mode ID value will
cause IQM to reject the plan.
>>Fluence Mode ID (3002,0052) Fluence ID if Fluence Mode (3002,0051) is
(mandatory if NON_STANDARD. If Fluence Mode ID is “FFF”,
(3002,0050) exists) then the beam is flattening filter free.
>Number of Control (300a,0110) Quantity of Control Points
Points VMAT=Qty of Segments + 1
IMRT=2*Qty of Segments (because each
Segment has two control points; even numbered
control points describe beam geometry
changes for the segment, and odd control
points define how many MU to deliver in the
segment).
>Control Point (300A,0111) Introduces sequence of control points.
Sequence
>>Nominal Beam (300A,0114) Nominal beam energy (MV) at control point.
Energy Note: Must be defined for the first control point. If
omitted in subsequent control points, value from
first control point is used.
>>Cumulative (300A,0134) Proportion of total MU assigned to this beam
Meterset Weight delivered by the end of this segment.
Note: The “Cumulative Meterset Weight”
(300A,0134) must be zero for the first control
point, and equal to “Final Cumulative Meterset
Weight” (300A,010E) for the last control point.
>>Gantry Angle (300A,011E) Gantry angle at control point.
Note: Must be defined for the first control point. If
omitted in subsequent control points, value from
first control point is used.

IQM User Reference Manual (v1.35a SW-v1.8) 6-37


Attribute Name Tag Description
>>Gantry Rotation (300A,011F) Direction of gantry motion starting at control
Direction point.
Note: The Gantry Rotation Direction (300A,011F)
is one of:
CW Clockwise
CC Counter-clockwise
NONE No rotation
The value must be NONE in the last control point.
>>Beam Limiting (300A,0120) Collimator angle at control point.
Device Angle Note: Must be defined for the first control point. If
omitted in subsequent control points, value from
first control point is used.
>>Beam Limiting (300A,011A) Introduces sequence of beam limiting device
Device Position positions at control point.
Sequence Note: The Beam Limiting Device Position
(conditional) Sequence (300A,011A) has multiple entries,
denoted by the RT Beam Limiting Device Type
(300A,00B8) value:
ASYMX Position of Asymmetric
X Jaws
X Position of X Jaws
ASYMY Position of Asymmetric
Y Jaw
Y Position of Y Jaws
MLCX Position of X-axis leafs
Note: In case the Linac has X jaws, one of “X” or
“ASYMX” must appear, and in case the Linac
has “Y” or “ASYMY” must appear. The correct
term is vendor/model dependent.
>>>RT Beam Limiting (300A,00B8) Type of beam limiting device.
Device Type
>>>Leaf/Jaw (300A,011C) Positions of beam limiting device.
Positions Note: All jaw and leaf positions are specified in
mm using IEC 61217 coordinates.

6.4 Software Configuration File IQM.Config.ini


The IQM.Config.ini software configuration file is included in the same folder
where the software executables lie, i.e. in the installation folder on the IQM
Workstation, on the IQM Server, and any other computer which runs an IQM
application.

Sections within the configuration file are denoted by brackets, such as


[AppSettings]. Not all sections of the file are required for all applications, but the
[AppSettings] section is always required.

IQM User Reference Manual (v1.35a SW-v1.8) 6-38


A copy of the original configuration file(s) (after initial installation, and / or of the
most recently verified configuration) should be kept in a secure place for
reference.

The IQM.Config.ini file on each IQM Workstation can only be edited by the
following Active Directory users logged on to the IQM Workstation:
IQMuseradmin or a member of the IQMmedphysGroup Security Group (or
another user with this permission, as implemented during installation).

The IQM.Config.ini file on the IQM Server can only be edited by the
IQMuseradmin Active Directory user.

To review and edit the Clinical Rules, log in as an authorized user (member of
IQMmedphysGroup or IQMuseradmin) to the IQM Workstation. In File Explorer,
navigate to the IQM installation folder, by default “C:\Program Files
(x86)\IQM\”. Open the IQM.Config.ini file using a text editor.

Caution:
Changes to the configuration file must be made with care.
Invalid or improper settings can lead to performance issues of
the IQM system, including how and whether deviations are
presented.
Consult iRT Support for assistance when making changes to the
configuration file.

Caution:
iRT strongly recommends that the user perform acceptance
tests after making changes and before using the changed
configuration clinically.

Note: In the examples in the following subsections, the sections such as


[AppSettings] is noted for each group of parameters to clarify that the described
parameters belong to that section. In a valid IQM.Config.ini file however, there
can only be one occurrence of each section, otherwise the IQM software will
not start.

IQM User Reference Manual (v1.35a SW-v1.8) 6-39


6.4.1 [AppSettings] Section
To validate the syntax of edited [AppSettings] settings, save the edited file and
start IQM Monitor or IQM Calc application. If no error message occurs, the
settings are confirmed to be valid in syntax.

6.4.1.1 System Folders


The first keyword is the path to the log directory, which is currently the only folder
required on any computer that runs an IQM application.

Note: It is strongly recommended to use a local folder as the log file directory,
not a network location. Using a network location, especially with IQM Monitor,
might impact performance of the IQM application.

Parameter Description Default setting


LogDirectory Local directory where log files are written C:\IQM_Data\Logs
to (not a network location!)

Default setting for “LogDirectory” on an IQM Workstation:


[AppSettings]
LogDirectory = C:\IQM_Data\Logs

6.4.1.2 Database Settings


The IQM software uses an SQL database for sharing data between the different
software components and third-party systems. The database is installed in a
Microsoft SQL Server environment which is operated on the IQM Server. The
following parameters are required for proper database connection and
authentication.

Parameter Description Default setting


DataStorageAssembly Full name of data storage DataStorage5.Sql
Name assembly (DLL)
SqlSchemaName Name of the SQL database IQMDB
files (*.mdf, *.ldf, etc.)
SqlDbPath Path on IQM Server where the Only set on Server which
SQL database files will be hosts the database,
stored when the database is otherwise omitted:
created (*.mdf, log file, E:\IQM_Data\DB
filestream data folder)
SqlConnectionString Connection information for the DataStorage assembly,
consists of the following sub settings, consisting of the sub
parameters defined below (Server, AttachDbFilename,
Database, Trusted_Connection)

IQM User Reference Manual (v1.35a SW-v1.8) 6-40


Parameter Description Default setting
Server Name of the SQL server which Server:
should operate the database. IQMSERVER\SQLEXPRESS or
May be different for localhost\SQLEXPRESS
workstations and server. Workstations:
IQMSERVER\SQLEXPRESS

Note: IQMSERVER is the


Computer name of the
server and can be
replaced by the IP
address.
AttachDbFilename Path where the SQL database Only set on Server which
file will be stored on the local hosts the database,
computer. Set to "{1}\{0}.mdf". otherwise omitted:
This parameter will be {1}\{0}.mdf
populated with the SqlDbPath
and SqlSchemaName values
during runtime.
Database Set to "{0}". This parameter will {0}
be populated with the
SqlSchemaName value.
Trusted_Connection Set to "yes" (this means that yes
Windows Authentication is
used, not SQL Authentication).

Example for Database Settings on the IQM Server, or on an IQM Workstation


running a local SQL database:
[AppSettings]
DataStorageAssemblyName = DataStorage5.Sql
SqlSchemaName = IQMDB
SqlDbPath = E:\IQM_Data\DB
SqlConnectionString = Server=localhost\SQLEXPRESS;
AttachDbFilename={1}\{0}.mdf;
Database={0};Trusted_Connection=Yes

Example for Database Settings on an IQM Workstation connecting to a


database on the IQM Server (IQMSERVER):
[AppSettings]
DataStorageAssemblyName = DataStorage5.Sql
SqlSchemaName = IQMDB
SqlConnectionString = Server=IQMSERVER\SQLEXPRESS;
Database={0};Trusted_Connection=Yes

IQM User Reference Manual (v1.35a SW-v1.8) 6-41


6.4.1.3 Linac and Detector Settings (IQM Workstation only)

Linac & Detector Machine Identification Parameters


The two parameters, linear accelerator machine name MachineName and IQM
Detector serial number SystemSerial for which this IQM Monitor workstation is
configured, are required for correct functioning of IQM and should not be
changed after initial installation.

Example:
[AppSettings]
MachineName = EM01
SystemSerial = 0302101301

Parameter Description Example


MachineName Linac name as used in treatment plans EM01
(real machine name, not an alias)
SystemSerial Serial number of the IQM Detector 0302101301

Linac & Detector Communication Settings


The next group of settings identifies the libraries (DLL files, in .NET referred to as
“assemblies”) required to communicate with the particular Linac and detector
installed at the site.

Parameter Description & parameters Example/Default settings


LinacAssemblyName Name of the Linac Elekta:
communication assembly Linac4.ElektaICom

Varian:
Linac4.VarianAdi
LinacConnectString Connection information for 168.8.8.2
the Linac communication
assembly: Elekta:
168.8.8.2 /LAG=55
IP address of ICOM (Elekta)
or ADI (Varian) + optional Varian:
parameters (see 168.8.8.2
specification below table) /TD=”C:\TrajectoryLogs”
SysconAssemblyName Name of the IQM detector Syscon4.DevCon4
communication assembly
SysconConnectString Connection information for COM1
the detector
communication assembly:

IQM Serial port + optional


parameters (see
specification below table)

IQM User Reference Manual (v1.35a SW-v1.8) 6-42


Examples for specific configurations:

Elekta ICom
LinacAssemblyName = Linac4.ElektaICom /LAG=100
SysconAssemblyName = Syscon4.DevCon4
LinacConnectString = 168.1.1.10
SysconConnectString = COM1

Varian ADI + Trajectory Logs


LinacAssemblyName = Linac4.VarianAdi
SysconAssemblyName = Syscon4.DevCon4
LinacConnectString = 168.3.2.1 /TD=”C:\Trajectory”
SysconConnectString = COM2

The parameters are described in the following sections.

Optional parameters for Elekta LinacConnectString


The following parameters can be used in the LinacConnectString for
configuration with Elekta linacs.
• /LAG=<icom-lag-time> (milliseconds; default 50)
The icom-lag-time is the time subtracted from ICOM messages to get a
truer indication of the time the event really occurred.
• /SEGBUF=<segment-buffer-time> (milliseconds; default 300)
The segment-buffer-time is subtracted from the start time and added to
the end time of each segment.
• /FIELDBUF=<field-buffer-time> (milliseconds; default 1000)
The field-buffer-time is added to the end time of each field.

Optional parameters for Varian LinacConnectString


The following parameters can be used in the LinacConnectString for
configuration with Varian linacs.
For Varian TrueBeam and other linacs which write out trajectory log files:
• /TD=<trajectory-log-directory>
The trajectory-log-directory is the location in which the trajectory log files
will appear. Use multiple /TD entries if there is more than one trajectory
log directory, but only one /TT setting. Use "" to enclose paths with blanks.
• /TF=<trajectory-max-time-difference> (seconds, default
1)

IQM User Reference Manual (v1.35a SW-v1.8) 6-43


The trajectory-max-time-difference is the maximum allowable difference
between the timestamps in the .txt and .bin files. The minimum value is 0.
The default is 1.
• /TB
If the /TB parameter is set, the IQM software will only use the trajectory
.bin file (not the corresponding .txt file). This is required for newer Varian
TrueBeam linacs where the .txt file is omitted.

For Varian C-Series and other linacs which write out dynalog files:
• /DD=<dynalog-directory>
The dynalog-directory is the directory in which the dynalog files will
appear. Use multiple /DD entries if there is more than one dynalog
director. Use "" to enclosed paths with blanks.

For all Varian linacs:

• /TT=<log-file-timeout> (milliseconds, default 20000)


The log-file-timeout duration is the maximum time the Linac[v].VarianAdi
module will wait for an expected file (trajectory log or dynalog) before
timing out. This parameter can only be specified if /TD or /DD is also
specified.
• /SB=<segment-buffer-time> (milliseconds, default 300)
The segment-buffer-time is the amount of extra-time added to the start
and stop time of segments.
• /AD=<adi-logging-directory>
The adi-logging-directory is the location of where to log ADI packets for
servicing and problem investigation by iRT Support. The actual packets
will be in a subdirectory named ADI.yyyyMMdd.HHmmss.zzz. ADI packets
are NOT logged if the directory is not specified.
• /BD
The /BD (“beam data”) parameter enables an internal mode for handling
field data introduced to handle beam pauses. It is enabled by default if a
Trajectory Log directory is defined via the /TD parameter.
• /SE (deprecated)
The /SE (“segments at end”) parameter enables an internal mode for
handling field data. It is deprecated and should not be used without
advice by iRT Support as this mode does not support beam pausing. It will
be removed in upcoming releases.

IQM User Reference Manual (v1.35a SW-v1.8) 6-44


Optional parameters for SysconConnectString
• /ACCEL=<accel-ratio>
The accel-ratio is a percent ratio (integer 0 to 100) which indicates the
number of pre- and post-accelerometer samples which must be
received in each poll to prevent an Accelerometer error. By default, it is
75.

FIR Gantry Angle Filtering


During VMAT beam delivery, the Linac control system adjusts the gantry velocity,
along with the dose rate and MLC leaf and jaw positions, to deliver a predefined
dose in a given segment. The variations in gantry velocity can create
mechanical vibrations throughout the Linac. These vibrations are most
pronounced at the Linac collimator head, where the IQM system, including its
accelerometer, is located. The Linac's vibrations extend to the accelerometer
components and introduce noise into its readings, impacting the accelerometer
accuracy.

IQM supports a digital, software-based “FIR” (finite impulse response) filter, which
reduces the vibrational noise to the accelerometer’s total signal. This FIR filter
can significantly improve the accelerometer's ability to measure the true
orientation of the IQM system. The FIR filtering technology allows measured signal
to be assigned more accurately to individual VMAT segments, improving
“segment by segment” monitoring results.

Note that the additional FIR Filter data processing can delay the reporting of
signal deviations by up to 1 second.

Note: FIR Filtering will not generally improve results for VMAT arcs that start in a
blind arc region, near 0˚ and ±180˚. This is because the gantry angle uncertainty
in the blind arc regions prevents the accelerometer from determining a precise
starting angle for such an arc, and any error in the arc’s starting angle leads to
a systemic inaccuracy in the FIR filter results.

The decision to activate FIR filtering should be made by the responsible user in
consultation with iRT Support, who will then update the software configuration.

The FIR filter is set in the IQM.Config.ini configuration file in the [AppSettings]
section with the parameter PollFilter.

IQM User Reference Manual (v1.35a SW-v1.8) 6-45


Parameter Description Default setting
PollFilter One of “None”, ”FIR8” or “FIR10” None

The “None” choice results in gantry angles that


are the same as un-filtered angles

The FIR8 and FIR10 refer to coefficients in the


filtering algorithm. When a site decides to
implement gantry angle filtering, Support will
help determine the best option for local
conditions.

Gantry Angle (AngleAdjuster)


The IQM inclinometer reports gantry and collimator angles with every “poll”,
multiple times per second. From time to time, one of these polls reports an invalid
gantry or collimator angle, which can cause an Inclinometer Error in the IQM
Monitor application and stop monitoring for a field, if one is in progress, even if
all other inclinometer readings are valid.

IQM offers a configuration choice that resolves these isolated, momentary


invalid readings by replacing the invalid reported value with the average of the
preceding and following polls.

Parameter Description Default setting


AngleAdjuster One of “True” or ”False”. False

Indicates whether polls with invalid angles are


fixed: an isolated poll with an invalid angle is
given angles equal to the average of the
preceding and succeeding polls.

Settings for Dynamic Background Signal Handling


background signal is the activity measured by the IQM Detector when the beam
is off. Electrometer leakage is the main contributor of background signal. Section
6.2.5 describes how background signal is defined in the context of IQM and how
it is handled. This section describes how the Dynamic Background Signal
Handling mode can be enabled and configured.

Monitor offers a mode in which it identifies the current leakage and subtracts it
from all the poll values included in a treatment record. When this mode is
activated, Monitor constantly re-calculates the current leakage in between field
deliveries, when no significant signal should occur.

IQM User Reference Manual (v1.35a SW-v1.8) 6-46


Parameter Description Default setting
Leak.Enabled One of “True” or “False”. False
Determines whether background signal (i.e., not
handling is enabled. enabled)

Leak.WaitTime Determines how long Monitor should wait 2.0


after a FieldEnd event before starting to
acquire a background signal sample.
Leak.MeasureTime Determines the length (in seconds) of 5.0
Monitor’s measurement samples for
determining background signal
Leak.LeakRateLimit Sets an upper limit for the determined 100
background signal which will be used for
correction. If the calculated background
signal is higher than (Leak.LeakRateLimit /
PollFrequency), then (Leak.LeakRateLimit /
PollFrequency) is used as the correction
value.

Remarks:

1 If the time between establishing communication with both the detector


and the linac and loading the first field is less than (WaitTime +
MeasureTime), then there will be too little time to calculate a new
background signal value and no background signal correction will be
performed.
2 Likewise, if the gap between two fields is less than (WaitTime +
MeasureTime), then the previously determined value will be used for
background signal correction.
3 If the signal rate between fields is higher than the value of the
Leak.LeakRateLimit parameter due to exceptionally high background
signal, the system error “Early Beam Delivery” (Message Code:
FieldErrorEarlySignal) may be shown.

IQM User Reference Manual (v1.35a SW-v1.8) 6-47


6.4.1.4 Data storage performance analysis (DataStorageLogging)
To analyze performance of the data storage access, e.g. to see how long it
takes IQM Monitor to receive a response from the central database,
“DataStorageLogging” can be enabled. This should only be done temporarily
as it increases the amount of data recorded and therefore increases the size of
the log files.

Parameter Description Default setting


DataStorageLogging One of “True” or “False”. False
Indicates whether data storage calls and (i.e., not
their duration are logged. This setting should enabled)
only be enabled temporarily for database
performance analysis.

6.4.1.5 Environment Settings (IQM Workstation only)


The following optional parameters are used by Monitor to set ranges for the
expected local temperature and air pressure in which the IQM system will
operate.

Because air pressure and temperature values are used as correction factors in
IQM’s signal determination and can significantly impact measured signal values,
a system warning is given if IQM’s onboard sensors report temperature or air
pressure values outside these ranges.

If the onboard sensors do not report any valid temperature or air pressure values,
i.e. values inside these ranges, between the time that the IQM Monitor software
was started and the beginning of field delivery, default, predefined temperature
and pressure values will be used to correct the IQM signal:

Default Pressure: 760 mmHg


Default Temperature: 22.0° C

At the end of the field, the Monitoring Status line message will include the
caution that the reported values were out of range (with yellow coloring and
warning sound).

Note: These parameters may not be changed without consulting iRT Support, as
corresponding firmware settings also need to be updated.

Parameter Description Default setting


Temperature.Min Minimum expected temperature, in degrees 15
Celsius
Temperature.Max Maximum expected temperature, in degrees 35
Celsius
Pressure.Min Minimum expected air pressure, in mmHg 640

IQM User Reference Manual (v1.35a SW-v1.8) 6-48


Pressure.Max Maximum expected air pressure, in mmHg 815
PressureUnit Pressure unit displayed in Monitor. One of: MillimeterOfMercury
• MillimeterOfMercury
• KiloPascal
• HectoPascal
shown abbreviated in Monitor as mmHg, or
hPa, respectively.
Note: Regardless of this setting, the
Pressure.Min and Pressure.Max values must be
defined in mmHg.

6.4.1.6 Import and Calculation Settings (IQM Server only)


The following parameters are used by Calculator application and Calculator
Service.

Parameter Description Default setting


PlanImportDir Folder containing DICOM plan files which are C:\IQM_Imports
being imported by IQM
CalcMode Options: Full
“None”: no calculation performed, only import;
“Full”: import and calculation performed

CalcInterval Number of milliseconds between attempts to 60000 (1 minute)


import and calculate new plans.
CalcThreads Number of calculation threads to spawn, 1 (one thread)
expressed as integer. The limit depends on the Recommended:
number of cores available. 0 or -1 if no other
Positive integers specify the absolute number of performance-
threads which will be used during calculation. Zero critical software
and negative integers specify how many threads running on the
to leave available for other tasks (for example, computer, or -2 if all
“CalcThreads= -2” on a computer with 8 cores will IQM applications
use 6 calculation threads.) are running on one
computer

Default settings:
[AppSettings]
PlanImportDir = C:\IQM_Imports
CalcMode = Full
CalcInterval = 60000
CalcThreads = 1

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6.4.1.7 Reference Update Strategy Setting (IQM Workstation only)
This parameter controls when Monitor should record a new measured reference
record and set it as the current baseline.

Parameter Description Default


settings
ReferenceUpdate When Monitor should record a new measured KeepCurrent
Strategy reference during field delivery. Reference

Options:
“KeepCurrentReference”:
Keeps the current reference as is. If a calculated
reference exists, Monitor will continue to use it for all
subsequent deliveries. Only if Record mode, when
there is no calculated reference, will Monitor update
the current reference.
“ReplaceCurrentReference”: Always replaces the
current reference with the newest measurement.
“ReplaceCurrentCalcReference”: Replaces the
current reference in Record mode (when there is no
reference) and in verification mode when the current
reference is a calculated reference.

6.4.2 [Rules] Section (IQM Workstation only)


To validate syntax of the [Rules] settings after editing, save the IQM.Config.ini file
and start IQM Monitor. If no error message occurs, the syntax of the setting is
considered valid.

6.4.2.1 Clinical Rules for Signal Deviation


The Clinical Rules define the thresholds and limits for what deviations are
considered in the range of normal accelerator operation, what deviations are
considered out of the range of normal operation but small enough to investigate
after the treatment concludes, and what deviations are significant enough to
call for attention by audible and visible alarm function.
Refer to section 6.1 Clinical Rules (Criteria settings for Clinical Alerts & Alarms) for
detailed information about configuring the Clinical Rules.

6.4.2.2 Merge and Running Average Rules


The Merge rules define whether segments should be merged together while
being compared.
[Rules]
VMAT.Merge.MinSpan = 1.0
[Mode].Merge.MinMU = 1.0

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VMAT.RunAvg.Mode = none

Refer to section 6.2 for detailed information about configuring the Merge Rules.
Parameter Description Default setting
VMAT.Merge. Minimum gantry span, in decimal degrees, for a 1.0
MinSpan segment to be individually evaluated; segments
that span a smaller range are merged with the next
segment. Only valid for VMAT fields. If defined,
value must be greater than zero. One decimal
place supported (N.N).

VMAT.Merge. Minimum segment MU for a segment to be 1.0


MinMU individually evaluated; segments with smaller MU
values are merged with the next segment(s) until
the group’s total MU is at least this value. Valid for
VMAT and non-VMAT fields. If defined, value must
be greater than zero and less than or equal to 10.
One decimal place supported (N.N).

VMAT.RunAvg. One of “None” or “SimpleCenteredExt”. None


Mode Defines how VMAT segments are smoothed for
evaluation and display.

VMAT.RunAvg. Sets the number of segments used in the running not defined
Count average, only applies if VMAT.RunAvg.Mode is not
“None.” The “Count” must be an odd integer equal
to three or more. Recommended value is “5”.

6.4.3 [SystemLimits] Section (IQM Workstation only)


Relevant parameters to be set in the [SystemLimits] section are described as
follows. If not set in the IQM.Config.ini configuration file, the default values are
applied. The default values are the recommended values, if not specified
otherwise.
Note: These parameters may not be changed without consulting Support, as
adverse settings can lead to high numbers of “false positive” deviations.

Parameter Description Default setting


GantryError Tolerance, in degrees, for identifying the 0.2
current segment in VMAT fields, and
comparing the gantry angle in the plan (Recommended:
to the gantry angle detected by IQM. 1.0)
Valid range [0.0 to 3.0].

IQM User Reference Manual (v1.35a SW-v1.8) 6-51


Parameter Description Default setting
PollFrequency Number of polls to acquire per second. 5.0
Minimum value is 1.0.

MinSignalRate Signal counts rate (counts per second) in 100


a poll for the beam to be considered (if PollFrequency =
“on” within a segment. Must be greater 5, i.e. polling at
than zero. 5Hz, corresponds
to a poll signal
value of 100/5=20)
MinErrorRate Signal counts rate (counts per second) in 500
a poll for the beam to be considered (if PollFrequency =
“on” outside of a segment. Must be 5, corresponds to
greater than zero. a poll signal value
Signal rates higher than the MinErrorRate of 500/5=100)
outside of a segment trigger a signal
error which currently leads to premature
ending of monitoring.
MinErrorCount Number of consecutive polls to which 1
the MinErrorRate settings must be
applied for the beam to be considered
“on” outside of a segment (the poll
values are averaged) Must be an integer
greater than 0.
BlindHalfArc Span, in degrees, of one half of each 2.0
Blind Arc region. Valid range [0.0 to 5.0].

The BlindHalfArc value is used to


combine segments when allocating
signal. When more than one segment
span a Blind Arc region, any signal for
any of those segments is averaged
between them. So if there are two
segments in the blind arc region around
gantry 0/360, then they will end up with
the same signal value.

MinRefSignal Signal count value used for comparison 0.1


in case original signal counts are zero.
Must be 0.1 or more.

MaxUnrepSegments Maximum number of unreported 1


segment before a missing segments error
is generated. Specific to Elekta ICOM
monitoring, to handle the rare situation
that a very small segment is delivered so
quickly that its segment number is never
broadcast by the Linac. Must be an
integer equal to or greater than 0.

IQM User Reference Manual (v1.35a SW-v1.8) 6-52


Parameter Description Default setting
FieldMUError Maximum acceptable difference (in 0.1
fraction of MU) between:
1. MuPlanned (MU linac plans to deliver)
and MuField (MU as per treatment plan)
at field start, and
2. MuPlanned (MU linac plans to deliver)
or MuField (MU as per treatment plan)
values and the MuDelivered value (MU
linac reports was delivered) at field end.
Valid range [0.0 to 2.0]

6.4.4 Configuration File Error Codes (IQM Workstation only)


System Errors caused by problems in the configuration files typically prevent IQM
Monitor from running. A Configuration Error message appears at startup, as soon
as the IQM Monitor application is launched.

Figure 101 - Configuration Error message, as potentially shown when IQM Monitor is started

The System Error dialog box message shows the configuration file and specific
element that is causing the problem.

Other System Error messages may occur after the Startup Alarm Test (described
in chapter 4.6) when IQM Monitor establishes communication with the Linac and
IQM Detector.

IQM User Reference Manual (v1.35a SW-v1.8) 6-53


Figure 102 - Configuration Error message related to Linac communication, with Message Code.

The following tables list the configuration error messages and their causes.

In the case of a configuration error, please make a note of the message code,
if provided, or the error message and contact iRT Support.
Linac Communication Errors (see Table 8) reflect temporary issues that
sometimes correct themselves.
Table 8 – Linac Communication Errors shown at Startup

Monitoring Status Line Dialog Message Text


(Title: Linac Communication Problem (may clear
itself)
Linac communication Communication between the IQM software and the
problem, may clear Linac record & verify system has been temporarily
itself interrupted. If this issue does not resolve itself, there
may be a problem with the network connection, or
the linac record & verify system may not be online.
Message Code: LinacStatusCommError.Unknown
Linac communication Communication between the IQM software and the
problem, may clear Linac record & verify system has been temporarily
itself (IOError) interrupted. If this issue does not resolve itself, there
may be a problem with the network connection, or
the linac record & verify system may not be online.
Message Code: LinacStatusCommError.IOError

The Linac connection configuration errors described in Table 9 prevent the IQM
System from running successfully. The IQM Monitor application must be closed,
the problem corrected, and IQM Monitor re-started.

IQM User Reference Manual (v1.35a SW-v1.8) 6-54


Table 9 - Linac Connection Configuration Errors shown at Startup, Typically
Requiring User Intervention

Monitoring Status Line Dialog Message Text


(Title: Linac Configuration Problem)
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
established.
Check that the Linac record & verify system is
active and that network connection to the
record & verify system and configured network
paths exists.
The designated responsible user should review
the settings. If the problem persists, contact IQM
Support.
Message Code: LinacStatusPermError.Unknown
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
(InvalidConnectString) established.
If the Linac is running, the settings for the
LinacConnectString parameter in the
IQM.Config.ini file may not be valid in terms of
syntax (e.g. IP address).
The designated responsible user should review
the settings. If the problem persists, contact IQM
Support.
Message Code:
LinacStatusPermError.InvalidConnectString
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
(CannotLoadCommAsse established. The Linac communication module
mbly) failed to load.
Please contact IQM Support.
Message Code:
LinacStatusPermError.CannotLoadCommAssem
bly

IQM User Reference Manual (v1.35a SW-v1.8) 6-55


Monitoring Status Line Dialog Message Text
(Title: Linac Configuration Problem)
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
(CannotLoadVendorDLLs) established. The Linac manufacturer-specific
assemblies required by the Linac
communication module failed to load.
Please contact IQM Support.
Message Code:
LinacStatusPermError.CannotLoadVendorDLLs
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
(InvalidVendorDLLs) established. The Linac manufacturer-specific
assemblies required by the Linac
communication module are invalid. They may
be the wrong versions or corrupted.
Please contact IQM Support.
Message Code:
LinacStatusPermError.InvalidVendorDLLs
Linac configuration Communication between the IQM software and
problem the Linac record & verify system could not be
(CannotConnect) established. Could not connect to the Linac
record & verify system or to a required network
path.
Check that the Linac record & verify system is
active and that network connection to the
record & verify system and configured network
paths exists.
The designated responsible user should review
the settings. If the problem persists, contact IQM
Support.
Message Code:
LinacStatusPermError.CannotConnect
Linac configuration The Linac name being broadcast does not
problem match the Linac name defined in the
(MachineNameConflict) IQM.Config.ini file (parameter
AppSettings.MachineName).
The designated responsible user should review
the settings. If the problem persists, contact IQM
Support.
Message Code:
LinacStatusPermError.MachineNameConflict

IQM User Reference Manual (v1.35a SW-v1.8) 6-56


Detector Communication Errors (see Table 8) may reflect temporary issues that
sometimes correct themselves.

Table 10 - Detector Communication Errors shown at Startup, Potentially Self-


correcting

Monitoring Status Line Dialog Message Title & Text


Detector communication Detector Communication Problem (may clear
problem, may clear itself itself)
Communication between the IQM software
and the IQM Detector has been interrupted. If
this issue does not resolve itself, there may be a
problem with the network connection, or the
detector may not be online.
Message Code:
SysconStatusCommError.Unknown
Detector communication Detector Communication Problem (may clear
problem, may clear itself itself)
(IOError) Communication between the IQM software
and the IQM Detector has been interrupted. If
this issue does not resolve itself, there may be a
problem with the network connection, or the
detector may not be online.
Message Code: SysconStatusCommError.IOError
Caution: Critically low Caution: Shutdown due to Low Battery
detector battery The remaining battery power is too low to
maintain communication with the detector. The
detector will shut itself down momentarily.
Recharge the detector before resuming
monitoring.
Message Code:
SysconStatusCommError.LowBattery
Detector communication Detector Communication Problem:
problem, may clear itself Inclinometer Error (may clear itself)
(InclinometerError) An inclinometer error was received from the
IQM Detector, or the detector was moved in an
unexpected manner (angular velocity not
within the expected range).
Restart the detector and if the issue persists,
contact IQM Support.
Message Code:
SysconStatusCommError.InclinometerError

IQM User Reference Manual (v1.35a SW-v1.8) 6-57


Detector communication Detector Communication Problem:
problem, may clear itself Electrometer Error (may clear itself)
(ElectrometerCountsNotZe An electrometer error was received from the
ro) IQM Detector.
Restart the detector and if the issue persists,
contact IQM Support.
Message Code:
SysconStatusCommError.ElectrometerCountsNot
Zero
Detector communication Detector Communication Problem:
problem, may clear itself Electrometer Error (may clear itself)
(ElectrometerError) An electrometer error was received from the
IQM Detector.
Restart the detector and if the issue persists,
contact IQM Support.
Message Code:
SysconStatusCommError.ElectrometerError
Detector communication Detector Communication Problem:
problem, may clear itself Electrometer Error (may clear itself)
(HVDidNotTurnOn) An electrometer error was received from the
IQM Detector.
Restart the detector and if the issue persists,
contact IQM Support.
Message Code:
SysconStatusCommError.HVDidNotTurnOn

The detector configuration errors described in Table 11 prevent the IQM system
from running successfully. The IQM Monitor application must be closed, the
problem corrected, and IQM Monitor re-started.

Table 11 - Detector Configuration Errors shown at Startup, Typically Requiring


User Intervention

Monitoring Status Line Dialog Message Text


(Title: Detector Configuration Problem)
Detector configuration The IQM.Config.ini file has errors related to
problem communication with the IQM Detector.
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code: SysconStatusPermError.Unknown

IQM User Reference Manual (v1.35a SW-v1.8) 6-58


Monitoring Status Line Dialog Message Text
(Title: Detector Configuration Problem)
Detector configuration The connection string specified in the
problem IQM.Config.ini file may not be valid in terms of
(InvalidConnectString) syntax (parameter
AppSettings.SysconConnectString).
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code:
SysconStatusPermError.InvalidConnectString
Detector configuration The DevCon module specified in the
problem IQM.Config.ini file (parameter
(InvalidFirmwareVersion) AppSettings.SysconAssemblyName) does not
match the firmware version of the IQM Detector.
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code:
SysconStatusPermError.InvalidFirmwareVersion
Detector configuration The port specified in the IQM.Config.ini file is
problem (InvalidPort) invalid (parameter
AppSettings.SysconConnectString).
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code: SysconStatusPermError.InvalidPort
Detector configuration The port specified in the IQM.Config.ini file
problem (parameter AppSettings.SysconConnectString) is
(PortAlreadyOpen) already in use by another process.
Please close all open applications and restart the
detector as well as the Monitor application. If the
problem persists, contact IQM Support.
Message Code:
SysconStatusPermError.PortAlreadyOpen
Detector configuration The port specified in the IQM.Config.ini file does
problem not exist (parameter
(PortDoesNotExist) AppSettings.SysconConnectString) or the port was
not found, possibly due to a communication
problem.

IQM User Reference Manual (v1.35a SW-v1.8) 6-59


Monitoring Status Line Dialog Message Text
(Title: Detector Configuration Problem)
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code:
SysconStatusPermError.PortDoesNotExist
Detector configuration The serial number communicated by the IQM
problem Detector does not match the serial number
(WrongSystemSerialNum specified in the IQM.Config.ini file (parameter
ber) AppSettings.SystemSerial).
The designated responsible user should review the
settings. If the problem persists, contact IQM
Support.
Message Code:
SysconStatusPermError.WrongSystemSerialNumber

6.5 IQM Database


The IQM software uses an SQL database for sharing data between the different
software components and third-party systems, referred to as the “IQM
Database”. The database is installed in a Microsoft SQL Server 2014 environment
which is operated on the IQM Server and uses Windows authentication, using
Active Directory Security Groups and Users when logging in to the IQM
Workstations and computers running IQM Review.

The machine and chamber configuration files which characterize each linear
accelerator and detector are created and imported into the IQM Database as
part of the installation and commissioning procedure.

6.5.1 Machine Configuration File


Each machine (i.e. Linac) to be used with an IQM Detector must have a
Machine configuration file for that accelerator stored in the IQM Database.
Changes to the machine may require the machine configuration file to be
updated, for example if the MLC hardware is upgraded or if the site decides to
commission the IQM System for another energy. Please consult IQM Support for
information if needed.

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6.5.2 Chamber Configuration File
Chamber (detector) configuration files are machine-specific. The
characterization data in the chamber configuration file only apply to the
machine with which they were measured. Chamber configuration files are
stored in the IQM Database. Please consult IQM Support for information if
needed.

6.6 Periodic QA of the IQM System


It is recommended that the responsible user perform periodic QA tests with the
IQM to verify that the system as implemented in the clinical network functions as
expected.

The need for periodic QA should be considered:

• at annual, bi-annual or other QA intervals, as determined by the Medical


Physics staff
• after installing IQM software updates
• after service or repair on the IQM hardware
• after major linear accelerator service or repair
• after network configuration changes, updates, or repairs

Periodic QA may be performed by re-exporting a known treatment plan with


specific characteristics and re-applying the IQM workflow. IQM should receive
the plan and calculate the expected IQM signal for the plan automatically.
Then, the plan should be delivered and the resulting IQM Measured Signal
Record compared with previous deliveries of the same plan.

During the IQM System commissioning and installation, test plans are received,
calculated and the resulting treatments monitored. These test plans may be
repeated for use for periodic QA. An example of the QA Field Test plan as used
during installation is supplied for reference in Appendix 1.

An institution-specific or linac-specific test plan created by the user may be used


in addition to (or instead of) the standard IQM acceptance test and
commissioning plans. The user can choose performance variables (gantry
position, field sizes and shapes, number of segments or control points, dose rates)
which reflect the clinic’s local practice and priorities. This local QA test plan and
acquired baseline measurements can be used for periodic QA and to evaluate
the performance of IQM and the linac after service interventions.

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6.6.1 After Update of the IQM Software
After each IQM software update, it is recommended to execute the IQM
workflow using a known plan or plans. A plan may be imported and the beams
delivered in order to verify the IQM Calculator (CALC) software workflow as well
as the IQM Monitor (MON) workflow. A previously monitored plan can be
delivered again and the measured results compared with previously measured
results.

The software release notes for each software release provide useful information
about what has changed and should be consulted by the user when planning
acceptance activities.

6.6.2 After Service of the IQM Detector


Should the detector require service, it is recommended to repeat the detector
acceptance tests as performed during installation. These include the tests for
reproducibility, linearity, dose dependence and the QA field test (gradient
response and symmetry).

It is also recommended to inspect and compare the deviation between


measurements of a given plan before and after the service intervention.

Ideally, the IQM QA Test Plan or a QA plan developed by the user should be
monitored before and after the service is performed. These before and after
measurements can then be compared with the same QA plans monitored at
the time of acceptance testing.

6.6.3 After Service of the Linear Accelerator


Before bringing the CALC software functionality of IQM into clinical use, several
commissioning measurements (AOFs, OARs) are performed and the acquired
data used to implement the calculation of expected reference signal datasets.
If the calibration of the linear accelerator changes significantly, the
commissioning data must be inspected to determine whether it captures the
performance characteristics of the treatment machine. If not, the
commissioning measurements must be repeated and the commissioning of IQM
CALC repeated for that linac.

Any change in the calibration of the linac which is significant enough to require
an adjustment of the treatment planning data, or which requires new
measurements for the TPS beam data, will typically require commissioning
measurements for IQM (AOFs, OARs) to be repeated as well.

Often, service of the linear accelerator is performed in order to maintain


calibration conditions or to return the accelerator to its calibration conditions.
Therefore, previously acquired AOFs and OARs may continue to be valid If the

IQM User Reference Manual (v1.35a SW-v1.8) 6-62


linac is restored to the previous calibration conditions. It is recommended to
inspect and compare the deviation between two measurements of a given plan
before and after the service intervention. Otherwise, the AOF and OAR
measurements should be repeated and the commissioning for CALC repeated.

Changes in calibration of the Linac’s gantry and collimator angle


potentiometers require also a new IQM inclinometer offset and angle
calibration. Please consult IQM Support for information about how to check and
correct the calibration, if needed.

6.6.4 After Other Changes in the RT Network


When components in the RT network are changed or updated (e.g. IP address,
port, trajectory log file format, ADI (for Varian)/ICOM (for Elekta) protocol
version), it is the responsibility of the hospital to verify that the IQM System
continues to work as expected. Delivering a known plan for which baseline data
is available for comparison is the recommended starting point for any analysis of
performance.

If the connection to the TPS has changed, the known plan should be re-exported
from the TPS and re-imported to the IQM database, and the newly imported
plan used for monitoring. See the section 3.3 Information for Persons Responsible
for the Network and IT Installations for more information.

IQM User Reference Manual (v1.35a SW-v1.8) 6-63


6.7 Calculation Application and Algorithm

6.7.1 Calculation Algorithm


The IQM chamber has several unique characteristics when compared to
conventional chambers routinely used in radiotherapy. These properties enable
the chamber to uniquely identify individual segments, encoding aperture shape,
aperture position and intensity into a single signal. Unlike a conventional ion
chamber used in dosimetry which samples a point of interest within a radiation
field, the IQM chamber encompasses the entire radiation field, and so the
chamber signal is a composite of radiation interactions on multiple points on the
detector coming from both the open aperture shape and transmission through
collimation elements. The signal calculation algorithm models dose fluence from
the entire field sampled by the chamber.

Figure 103 - A schematic representation of the accelerator geometry modelled by the IQM
calculation algorithm. Radiation from a point source at the target and an extended source at the
level of the flattening filter is propagated to the IQM chamber, represented by a wedge at the
bottom of the model, through multiple collimating elements consisting of primary collimator, MLC
leaves and jaws.

IQM User Reference Manual (v1.35a SW-v1.8) 6-64


6.7.1.1 Calculation Framework
The IQM signal is calculated for each distinct segment in a treatment beam.

A segment, defined by a treatment planning system, is typically defined by two


bounding aperture configurations, commonly referred to as control points, as
well as the set quantity of radiation to be delivered over the interval, typically
given as the number of monitor units, U. The signal calculation for each segment
divides the area of the IQM chamber into a rectangular grid. The relative
response at a point on the chamber to a pencil beam of radiation, S_IQM (i,j), is
multiplied by the radiation fluence at the corresponding point in the beam. The
sum of the elements of this signal array, multiplied by appropriate normalization
factors and the segment monitor units, results in the calculated IQM signal.

6.7.1.2 Calculation Components


The IQM detector is a transmission chamber that fully encompasses the radiation
beam. The signal is comprised of contributions from open regions of the field as
well as attenuated radiation passing through beam collimating elements. The
IQM signal for a beam segment, CIQM, delivering U monitor units, is given by the
equation:
𝑛,𝑚
𝑁𝐼𝑄𝑀
𝐶𝐼𝑄𝑀 = 𝑈 ∙ 𝐴𝑂𝐹(𝑓𝑖𝑒𝑙𝑑𝑠𝑖𝑧𝑒) ∙ ∙ ∑ 𝑆𝐼𝑄𝑀 (𝑖, 𝑗) ∙ 𝐼(𝑖, 𝑗)
𝑛×𝑚
𝑖,𝑗

𝑛,𝑚
𝑁𝐼𝑄𝑀
= 𝑈 ∙ 𝐴𝑂𝐹(𝑓𝑖𝑒𝑙𝑑𝑠𝑖𝑧𝑒) ∙ ∙ ∑ 𝑆𝐼𝑄𝑀 (𝑖, 𝑗) ∙ ((1 − 𝑓𝑆 )𝐼𝑃 (𝑖, 𝑗) + 𝑓𝑆 𝐼𝑆 (𝑖, 𝑗))
𝑛×𝑚
𝑖,𝑗

where

i,j indicate positional indices within an 𝑛×𝑚 calculation array,


NIQM is a normalization constant derived from a 10×10cm² reference field,
AOF(fieldsize) is an aperture size parameter accounting for machine output
variation with field dimensions

The impact of the aperture shape and position on the signal are determined by
the factors under summation: the chamber sensitivity map SIQM(i,j) and the
beam intensity I(i,j). The signal calculation is further refined by considering
contributions different sources of radiation: IP, the point source of radiation
emanating from the target of the machine, and IS, an extended source of
radiation. The parameter fS is a mixing factor which permits adjustment of the
component contributions.

IQM User Reference Manual (v1.35a SW-v1.8) 6-65


Chamber Sensitivity Map
The chamber sensitivity map (CSM) is an array normalized to 1.0 on the beam
central axis which characterizes the response of chamber at points away from
the central axis. The CSM intensity values are roughly proportional to the ratio of
the electrode separations at points of interest. The CSM can be measured using
heavily shielded stereotactic apertures which limit the transmission signal outside
the open field.

Figure 104 - The wedged shape of the IQM chamber gives rise to a positional gradient in the
sensitivity. Exposing the chamber at different points to small fields enables the construction of 2D
chamber sensitivity map

Fluence Intensity Calculation

6.7.1.2.2.1 Primary Fluence


The primary fluence array is constructed by first calculating an array of
transmission values across the entire field based on a point source of radiation
and assuming divergence matching of all collimating element edges. This
approximation allows for the simultaneous assessment of transmission values
through multiple layers of collimation which may be in motion over the course of
a beam segment. The position of collimating elements is determined from a plan
file (DICOM-RT or RTP). Both static (step and shoot) and dynamic (VMAT/sliding
window) calculations use the same primary transmission calculation and include
effects of interleaf transmission and tongue and groove leaf edge overlap.

Once a transmission array has been fully calculated, the primary fluence IP is
derived by multiplying the transmission at each point by the wide field intensity
parameterized by the off-axis ratio (OAR). The OAR is assumed to be a radial

IQM User Reference Manual (v1.35a SW-v1.8) 6-66


symmetric intensity function derived from in-water profiles for the largest field
sizes.

a)

b)

Figure 105 - Primary transmission geometry for a beam segment.


The time averaged transmission through collimating elements for an area on the IQM chamber
shown by the dashed blue square. Section a) shows a BEV of the leaf bank positions (green and
cyan) and jaw positions (magenta) at the start of the segment, while b) shows the position of the
same elements at the ended of the segment. The overlap of leaves illustrates the regions where
a tongue and groove effect is taken into accounted.

6.7.1.2.2.2 Extended Source Fluence


The extended source fluence is modelled as a plane located at the position of
the flattening filter. The source itself is assumed to have a Gaussian shaped
spatial source intensity and an angular emission intensity based on the Klein-
Nishina differential scattering cross section for Compton scattered photons.
Transmission factors are applied to source intensities for oblique ray line paths
through collimating elements from each point in the source plane to each point
on the IQM detector. Due to the complex geometry of the source and
collimator, calculations are performed only for the static collimation
configuration at the start and the end of the beam segment.

IQM User Reference Manual (v1.35a SW-v1.8) 6-67


dSS

xSS′,ySS′

dIQM

xd′,yd′

Figure 106 - Geometry for extended source fluence.


The contribution to a point on the chamber is function of both the source intensity,
modeled as a 2D Gaussian, and the Compton scattering angle.

The calculation algorithm can be configured to treat the extended source as


either circular or rectangular to support variation between different linear
accelerator models.

Chamber Normalization Factor


The chamber normalization factor NIQM is a simple scaling factor that relates the
measured signal for a reference field, CIQM (ref), to the calculation parameters.
Since, by definition, AOF(ref)=1.0, the normalization factor is simply given by the
ratio of the measured to the calculated intensity:

𝑛 × 𝑚 ∙ 𝐶𝐼𝑄𝑀 (𝑟𝑒𝑓)
𝑁𝐼𝑄𝑀 = .
𝑈 ∙ ∑𝑛,𝑚
𝑖,𝑗 𝑆𝐼𝑄𝑀 (𝑖, 𝑗) ∙ 𝐼(𝑖, 𝑗)

This relationship implies that any change in the characterization of collimating


elements or the chamber response would require a recalculation of the
normalization factor from existing measurements.

IQM User Reference Manual (v1.35a SW-v1.8) 6-68


1,0

0,9
Relative Intensity

1 MeV Photon
0,8
2 MeV Photon
0,7
4 MeV Photon

0,6
6 MeV Photon

0,5
0 5 10 15 20
Scattering Angle (degrees)

Figure 107 - Extended source intensity dependence on scattering angle.


The Klein-Nishina coefficients for Compton scattering dictate a strong dependence of intensity on
emission angle relative to the original photon direction. A monoenergetic curve is used for IQM
signal calculation, taken at 1/3 of the nominal photon energy.

Area Output Factor (AOF)


The area output factor, AOF(fieldsize), is a factor introduced to account for
residual machine output variations with field aperture size. Conceptually, this
factor is similar to the head scatter factor SC of conventional output calculation
systems but differs in this instance due to the nature of the IQM system itself. In
particular, the behavior of the AOF differs from SC in that 1) a major component
of the variation, the extended source IS is explicitly included in the calculation,
and 2) the intensity is calculated over the entire area of the chamber rather than
simply to a point on the central axis.

These features result in the AOF functioning as a residual factor for the
calculation; the AOF is derived in an analogous manner as the normalization
factor NIQM from a number of measurements using rectangular fields. The AOF
itself is accessed within the calculation for arbitrary fields by calculating an
average width and length for the field aperture.

The field size characterized in the AOF may be defined with two or three
variables. The two variable definition is based on the aperture width and length
as defined by the accelerator’s x- and y-jaws. The three variable definition is
suitable for sites implementing IQM for multi-lesion fields and certain other small

IQM User Reference Manual (v1.35a SW-v1.8) 6-69


fields, because it also takes into account the degree to which the MLC leaves
extend into the jaw opening.

Figure 108 - An example of an AOF table derived from a series of rectangular field
measurements.

6.7.2 Algorithm Limits and Limitations


The Math 3.1 calculation algorithm in the current IQM software supports beam
openings of any size and shape anywhere in the field. However, our research
partners have found that the expected signal IQM calculation for long (> 20cm),
narrow (<1.0 cm) far-off-axis field segments does not agree with measured signal
values for these beam openings with the same fidelity seen for other IMRT
calculations.

This limitation is related to the input data to the calculation algorithm, for which
the narrowest far-off-axis field measured is 1.0cm wide. Improvements to the
modeling of long, narrow far-off-axis fields are under active investigation and
are expected to be implemented in an upcoming clinical release. Until this time,
however, IQM users should be prepared to see significant deviations between
calculated and measured signals for long, narrow beam openings at the very
edge of the treatment area, and should consider using a measured reference
rather than a calculated reference when monitoring fields that include these
openings.

IQM User Reference Manual (v1.35a SW-v1.8) 6-70


6.7.3 Order of Plan and Field Calculations
The IQM Calc applications handle all the Dicom RT Plans present in the
“IQM_Imports” folder as a batch.

All plans in the “IQM_Imports” folder are processed (imported and calculated)
to the IQM Database in order of their timestamps, which most of the time, is the
order in which they were stored in the “IQM_Imports” folder.

For each treatment plan, for each Linac machine eligible to deliver the field (i.e.
for all matched machines) and each chamber (detector) commissioned for use
with the machine, each field is calculated and stored in the database.

To optimize calculation in terms of processing speed, machine/chamber pairs


are collected in calculation groups. All machine/chamber pairs in a group share
the same raw calculation, and only differ when it comes to applying the AOF,
CSM, OAR and Norm values.

The calculation process is as follows: for each calculation group, calculate all
fields in the plan (= raw calculation). For each raw field calculation, determine
and save the final field calculation result for each machine/chamber by
applying AOF, CSM, OAR and Norm values.

6.8 Dose Output Correction (DOC) Factor


IQM offers the user an optional method of applying a correction to measured
signals to account for a known daily dose variation. Some users observe variation
in output which presents itself as a consistent offset to the known calibration
conditions. For example, with a +2% output variation measured during Daily QA,
even if there are no delivery deviations, the measured IQM signal for every field
that day will be about 2% high. Conversely, if the Daily QA showed that the
output was -1% (low), the measured IQM signal for every field would be 1% low
without any other delivery deviation occurring. To address this, the department
can either implement wider watch and action limits for signal verification or
normalize this known variation out of the measured signal by implementing a
DOC factor as described in Appendix 5 Dose Output Correction & DOC Factor
Editor.

IQM User Reference Manual (v1.35a SW-v1.8) 6-71


IQM User Reference Manual (v1.35a SW-v1.8) 6-72
7 EMC Declarations per IEC 60601-1-2 (Edition 4.0)
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC) and must be installed or put into service
according to the EMC information provided in this manual.

Portable and mobile RF communications equipment, in particular equipment


with antennas, can affect medical electrical equipment. Keep portable
communications equipment at a safe distance away from the IQM System
components, at least 30 cm (12 inches). The detector contains a BLUETOOTH
module which should not be used within 20 cm of the patient. If the responsible
institution desires to use the detector at a distance smaller than 20cm, then it
shall perform SAR measurements, or otherwise determine that the SAR level is
acceptable.

To ensure EMC compliance, always use original parts supplied by iRT with the
IQM System as listed in the User Manual. The use of cables or components other
than those specified or manufactured by iRT Systems may result in increased
radiation emissions or decreased immunity of the equipment to electromagnetic
interference (EMI).

Do not use the equipment directly adjacent to other MEE equipment, or stacked
with other equipment. If use adjacent to other equipment or stacked with other
equipment is necessary, verify that the equipment performs as expected before
clinical use: Place the equipment in the intended configuration and observe the
performance to verify normal operation. Erratic measurements or lack of
measurements may indicate EMC disturbances. If repositioning the equipment
does not solve the problem, contact iRT for assistance.

The IQM has been tested in conformance with the current version of the EMC
standard IEC 60601-1-2. The following declarations follow the requirements as
described in IEC 60601-1-2:2014 (4th) edition.

For information concerning testing and EMC declarations in accordance with


IEC 60601-1-2:2007 (3rd) contact support@i-rt.de.

IQM User Reference Manual (v1.35a SW-v1.8) 7-1


7.1 Electromagnetic Emissions

7.1.1 ISM Classification per CISPR-11/EN 55011


CISPR-11 and the standard EN 55011 classify Industrial, Scientific and Medical
(“ISM”) equipment into two groups and two classes. The IQM System is Group 1,
Class A type equipment.

Group 1 Contains all ISM equipment which intentionally generates or uses


conductively coupled radio frequency (RF) energy that is necessary
for the internal functioning of the equipment
Group 2 Contains all ISM equipment which intentionally generates or uses
conductively coupled radio frequency (RF) energy in the form of
electromagnetic radiation for the treatment of material, and spark
erosion equipment
Class A Equipment suitable for all establishments other than domestic
Equipment not directly connected to a low-voltage power supply
network that supplies a building used for domestic purposes
Class B Equipment suitable for use in buildings used for domestic purposes
Equipment suitable for use in establishments directly connected to a
low-voltage power supply network that supplies buildings used for
domestic purposes

IQM User Reference Manual (v1.35a SW-v1.8) 7-2


7.2 Electromagnetic Emissions - per IEC 60601-1-2, 4th edition
EMC Table 1 - Guidance and Manufacturer’s Declaration—Electromagnetic
Emissions
The IQM System is intended for operation in a Professional Healthcare Facility environment,
assumed to be a controlled electromagnetic environment and as described below. The user
of the product shall ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment —
guidance
RF emissions Group 1 The IQM Detector and/or System has very
CISPR 11 low / no RF emissions and will not be the
cause of the interference in the near
electronic equipment.
RF emissions Class A The IQM Detector and/or System is
designed to be used in a Professional
Healthcare Facility Environment. It may
be used in all sites other than domestic
and those which connect directly to the
public low-voltage power supply network
which supplies domestic-purpose
buildings.

Harmonic Not applicable


emissions IEC
61000-3-2
Voltage Not applicable
fluctuations/
flicker emissions
IEC 61000-3-3

IQM User Reference Manual (v1.35a SW-v1.8) 7-3


7.3 Electromagnetic Immunity – per IEC 60601-1-2, 4th edition
EMC Table 2 - Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The IQM System is intended for operation in a specific electromagnetic environment, a
Professional Healthcare Facility (hospital) environment, assumed to be a controlled
electromagnetic environment and as described below. The user of the product shall ensure
that it is used in such an environment.
Immunity Test IEC 60601-1- Compliance Level Electromagnetic
2:2014 (4th ed.) environment – guidance
Test level
Electrostatic ± 8 kV contact ± 8 kV contact In a Professional
discharge (ESD) Healthcare Facility
± 15 kV air ± 15 kV air
Environment.
IEC 61000-4-2
The floors must be wood,
concrete or ceramic tile. If
the floors have synthetic
material covers, the
relative humidity must be a
minimum of 30%.
Electrical fast ± 2 kV for power ± 2 kV for power The mains power supply
transient/burst supply lines supply lines quality must be that of a
(on AC & DC, 100 (on AC & DC, 100 Professional Healthcare
IEC 61000-4-4
kHz repetition) kHz repetition) Facility Environment
(hospital)
± 1kV for ± 1kV for
input/output lines input/output lines
(100 kHz (100 kHz
repetition) repetition)
Surge ± 1kV Line(s) to ± 1kV differential The mains power supply
Line(s) mode quality must be that of a
IEC 61000-4-5
Professional Healthcare
± 2kV Line(s) to ± 2kV common
Facility Environment
Earth mode
(hospital)
Voltage dips, short Dips to 0% UT Dips to 0% UT The mains power supply
interruptions and for 1 cycle @ for 1 cycle @ quality must be that of a
voltage variations 0°phase angle 0°phase angle Professional Healthcare
on power supply Facility Environment
Dips to 70% UT Dips to 70% UT
input lines (hospital)
for 25/30 cycles for 25/30 cycles
IEC 61000-4-11 @ 0° phase angle @ 0° phase angle
Droppout to 0% UT Droppout to 0% UT
for 0.5 cycle for 0.5 cycle
@ 0°, 45°, 90°, @ 0°, 45°, 90°,
135°, 180°. 225°, 135°, 180°. 225°,

IQM User Reference Manual (v1.35a SW-v1.8) 7-4


IEC 61000-4-11 270°, 315° phase 270°, 315° phase
continued angle angle
Interrupts Interrupts
100% UT 100% UT
for 250/300 cycles for 250/300 cycles
Power frequency 30 A/m 30 A/m The power frequency
(50/60Hz) Power frequency Power frequency magnetic fields should be
magnetic field (50/60Hz) (50/60Hz) at levels of a location in a
IEC 61000-4-8 typical Professional
Healthcare Facility
Environment (hospital)
Note: UT is the AC mains voltage before the test level is applied.

IQM User Reference Manual (v1.35a SW-v1.8) 7-5


EMC Table 4 - Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The IQM System is intended for operation in a Professional Healthcare Facility environment,
assumed to be a controlled electromagnetic environment and as described below. The user of
the product shall ensure that it is used in such an environment.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and persons.
Immunity Test IEC 60601-1- Compliance Electromagnetic environment
2:2014 (4th ed.) Level — guidance
Test level
Radiated RF See Table 9 See Table 9 (below) Portable and mobile RF
Immunity (below) communications equipment
should be used not closer to the
IEC 61000-4-3
IQM System (including cables)
than the recommended
separation distance and in any
case not closer than 30cm (12
inches).
This is calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
Conducted RF 3 Vrms / 6 Vrms 3 Vrms
Immunity
150 kHz to 80
IEC 61000-4-6
MHz

For 3 V d = 1.2 √ P
Radiated RF 3 V/m 3 V/m
Immunity 80 MHz to 2.7
IEC 61000-4-3 GHz
1kHz 80%AM
modulation
For E= 3V/m d = 1.2 √ P

(table continued on next page)

IQM User Reference Manual (v1.35a SW-v1.8) 7-6


Immunity Test IEC 60601-1- Compliance Electromagnetic environment
2:2014 (4th ed.) Level — guidance
Test level
For E= 3V/m d = 2.3 √ P
where:
P is the maximum output power
(ERP) rating of the transmitter in
watts (W) according to the
transmitter manufacturer, and
d is the recommended separation
distance in meters (m).
E is the field strength (rms value)
(V/m)
To ensure disturbance free
operation of equipment, the field
strengths from fixed RF
transmitters, as determined from
an electromagnetic inspection or
site surveya, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked with
this symbol:

Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range
applies. (Table continued on next page)
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and persons.
Note a: Field strengths from fixed transmitters (such as base stations for radio telephones
(cellular and cordless), mobile radio, amateur radio, AM and FM radio broadcast and TV
broadcasts) cannot be accurately estimated. Assessment of the electromagnetic environment
as impacted by RF transmitters may require an electromagnetic site survey.
If the measured field strength in the location where the IQM System component is to be used
exceeds the applicable compliance levels described above, the system should be monitored
to verify that performance is normal. If abnormal performance is observed, additional
measures may be required, such as relocating or reorienting the components and repeating
the measurements.
Note b: For the frequency range 150 kHz to 80 MHz, field strengths shall be less than 3 V/m
(V1 V/m)

IQM User Reference Manual (v1.35a SW-v1.8) 7-7


EMC Table 9 - Guidance and Manufacturer’s Declaration—Electromagnetic Immunity to
RF Wireless Communication Devices (Radiated RF Immunity per IEC 61000-4-3)
The IQM System is intended for operation in a Professional Healthcare Facility environment, assumed to
be a controlled electromagnetic environment in conformance with the test levels described below. The
stated test level is the compliance level. The user of the product shall ensure that it is used in such an
environment.
Test frequency Band Service Modulation IMMUNITY
(MHz) (MHz) TEST LEVEL
(V/m)
Pulse modulation
385 380 to 390 TETRA 400 18 Hz 27
FM
GMRS 460, FRS 460 土 5 kHz deviation
450 430 to 470 1 kHz sine 28

710

745 704 to 787 LTE Band 13, 17 Pulse modulation 9


217 Hz
780

810 GSM 800/900, TETRA


800, iDEN 820, CDMA
870 800 to 960 Pulse modulation 28
850, LTE Band 5
18 Hz
930

1720 GSM 1800,


CDMA 1900,
1845 1700 to 1990 GSM 1900, DECT, Pulse modulation 28
LTE Band 1, 3, 4, 25; 217 Hz
1970 UMTS

Bluetooth, WLAN,
2450 2400 to 2570 802.11 b/g/n , RFID Pulse modulation 28
2450, LTE Band 7 217 Hz

5240
5100 to 5800 WLAN 802.11 a/n Pulse modulation 9
5500 217 Hz
5785

IQM User Reference Manual (v1.35a SW-v1.8) 7-8


7.4 Recommended Distances between Communications
Equipment and IQM System Components – IEC 60601-1-2, 4th
edition
EMC Table 6 - Recommended separation distances between portable and mobile RF
communications equipment and the IQM System components
The IQM System is intended for operation in an electromagnetic environment in which the
radiated RF disturbance is controlled. The customer or user can help prevent the
electromagnetic interference. Keep a minimum distance between portable and mobile RF
communications equipment (transmitters) and IQM Detector or other system components as
indicated below.
To determine the applicable recommended separation distance, use the maximum output
power of the communications equipment and the equation applicable to the frequency of the
transmitter, where P is the maximum output power (ERP) rating of the transmitter in watts (W),
as stated by the transmitter manufacturer.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and persons.
Separation distances according to the frequency of the transmitter (d in m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz

Applying the 60601-1 test levels V1=3, E1=3 results in:


Rated maximum
output power (ERP)
of transmitter / W
0.01 W 0.12 0.12 0.23
0.1 W 0.38 0.38 0.73
1W 1.2 1.2 2.4
10 W 3.8 3.8 7.3
100 W 12 12 23
Note 1: For transmitters rated at a maximum output power not listed here, the recommended
separation distance d in meters (m) can be calculated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W), as stated by the transmitter manufacturer.
Note 2: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

IQM User Reference Manual (v1.35a SW-v1.8) 7-9


7.5 Bluetooth® Implementation & Declarations
Bluetooth®1 Information
The IQM System is intended for operation in the bunker provided for the use of a medical
linear accelerator and installed in the configuration described in this manual.
The IQM Detector and the IQM Transceiver unit contain Bluetooth components with a modular
certification which allows them to be used according to the integration instructions of the
manufacturer while maintaining the validity of the certifications. For more information about
the Bluetooth modules used in the IQM, contact iRT Support.
The IQM with Bluetooth components installed has not been tested as a unit for SAR impact.
Therefore, it is not allowed to position the IQM detector closer than 20cm to any person. If the
responsible organization concludes that it is necessary or desirable to operate the detector at a
distance of closer than 20cm than that organization shall perform measurements or otherwise
verify that the SAR levels are acceptable.
Bluetooth module operating characteristics
RF Transmit 2.402-2.480 GHz (receiving and transmitting)
Power/Operation
Preferred frequency: none. Uses Bluetooth standard 2.1 and adaptive
Frequency
frequency-hopping spread spectrum (AFH) (79 designated Bluetooth
channels, each channel has a bandwidth of 1 MHz.)
RF Output Power Maximum permitted: 20 dB / 100 mW in EDR Mode (Class 1 transmitter)
(ERP) Typical: 18.84 dB / 76.6 mW in EDR Mode (Bluetooth standard 2.1)
2.402 GHz 2.441 GHz (middle) 2.480 GHz
16.3 dB typical 17.0 dB typical 18.8 dB typical
USA/FCC Contains Transmitter Module FCC ID: T9JRN41-3
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) this device may
not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired
operation
- This equipment has been tested and found to comply with the limits for
a Class B digital device, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy, and if not installed and used in
accordance with the instructions, may cause harmful interference to
radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.

IQM User Reference Manual (v1.35a SW-v1.8) 7-10


• Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Canada Contains Transmitter Module IC: 6514A-RN413
The module has been certified for use in Canada under Industry Canada
(IC) Radio Standards Specification (RSS) RSS-210 and RSS Gen. Modular
approval permits the installation of a module in a host device without
the need to recertify the device.
This device complies with Industry Canada license exempt RSS
standard(s). Operation is subject to the following two conditions: (1) this
device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operation
of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada
applicables aux appareils radio exempts de licence. L'exploitation est
autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas
produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout
brouillage radioélectrique subi, même si le brouillage est susceptible
d'en compromettre le fonctionnement.
European The module is an R&TTE Directive assessed radio module that is CE
Community marked and has been manufactured and tested with the intention of
being integrated into a final product.
The module has been tested to R&TTE Directive 1999/5/EC Essential
Requirements for Health and Safety (Article (3.1(a)), Electromagnetic
Compatibility (EMC) (Article 3.1(b)), and Radio (Article 3.2), European
Compliance Testing. A Notified Body Opinion has also been issued.
For more information about the regulatory status of Bluetooth modules used in the IQM
System, contact iRT.
1 The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth
Special Interest Group (Bluetooth SIG) Inc. and any use of such marks by iRT Systems is under
license. Other trademarks and trade names are those of their respective owners.”

IQM User Reference Manual (v1.35a SW-v1.8) 7-11


IQM User Reference Manual (v1.35a SW-v1.8) 7-12
8 Maintenance & Service of the IQM

8.1 Getting Support (Service) for the IQM System


Contact iRT Systems or the local distributor for service and support. Contact
information for local distributors may be found on the iRT website under the menu
item interactive.

Do not send any part of the system to iRT without authorization from iRT Customer
Support! If you ship your equipment without insurance or without an RMA
number, the shipment cannot be traced and any loss or damage will be at the
shipper’s risk and expense.

8.2 Contact information for iRT Support


Email: support@i-rt.de
Telephone: +49(261) 91545-0
Fax: +49(261) 91545-99
Post address:
iRT Systems
Customer Support
Schlossstrasse 1
56068 Koblenz, Germany

If you require assistance, service or a repair, contact iRT Customer Support by


phone, email or fax to receive instructions about how to proceed.
Important: Do not send any equipment to iRT for service or repair before
obtaining an RMA number or other authorization from iRT Customer Support!
Include the product name and the device serial number(s) when referring to this
device for any reason (on the phone, per email, written repair order etc.).

8.2.1 Handling Patient-related Data in Support Communications


iRT handles all user and patient data with care and discretion and in according
to data protection and privacy laws.
If the user supplies files such as DICOM-RT or treatment planning files containing
demographic patient data which indicate the patient’s identity, such as name
and date of birth, as part of a support interaction with iRT, the file should be
anonymized, for example, using a tool to edit the DICOM fields. If data must be

IQM User Reference Manual (v1.35a SW-v1.8) 8-1


supplied where patient name or date of birth is still present, contact iRT Support
to arrange for secure handling of these data.
IQM Treatment Reports contain the patient name, patient ID and date of birth.
If the user needs to send a copy of a paper report in order to get assistance with
reports (or a scan or fact of the report) It is recommended that the user cross out
the patient name with a marker before sending a report to iRT.

If a report is received with a patient name visible, the name will be blacked out
with a marker by Support staff. The received sample report will be immediately
destroyed / deleted as soon as the inquiry from the user has been reviewed.

All Support staff are trained to observe for sensitive patient data in their
interactions with users and as part of their duties in their support and service role,
and to handle this data with appropriate caution and care.

If data or records with patient identification are received or viewed as part of


Support activities, these are handled in a safe and confidential manner, used
only for the purpose for which the data or records were provided and then
depending on the nature of the item and inquiry, deleted, destroyed or stored
as defined in the iRT Data Protection Policy. Contact Support if you have
questions about the policy or the handling of data or records.

8.2.2 Returning equipment to iRT


If it is intended to return the IQM or one of its accessories or components to iRT
for repair, inspection or to replace the battery, contact iRT Support for
instructions and to obtain an RMA “Materials Return Authorization” number. Do
not send any equipment to iRT for service or repair before obtaining an RMA
number or receiving authorization! If you ship your equipment without insurance
or without an RMA number, the shipment cannot be traced and any loss or
damage will be at the shipper’s risk and expense.
Note: Turn off the detector completely before shipment. The detector is off when
no LEDs are illuminated. Note: If only the power button is illuminated, the
detector is in Standby mode. Push the button for 2 seconds to turn the detector
off completely. Once the power button LED is off, the detector is Off mode and
can be shipped or stored.
Securely pack and ship the device, as shown below.

IQM User Reference Manual (v1.35a SW-v1.8) 8-2


Pack the equipment AS INSTRUCTED BY iRT in the special white cartons in which
the equipment was delivered, and place these in the original shipping carton or
in a sturdy shipping container (for example, double corrugated cardboard)
large enough to provide space for at least 2cm of cushioning (bubble wrap or
foam peanuts) between the white cartons and the external shipping carton.
Together these provide sufficient protection for shipping.
Arrange the packing material so that the power button is not accidently pushed
during shipment, so that the device remains off.

Figure 109 - Packing the detector for shipment

Prepare the IQM Detector for shipping


by placing it in the original white
carton and using the original
protective foam.
Place the white carton in the shipping
carton, taking care to fill at least 2 cm
of packing material (foam, Styrofoam
peanuts or similar) between the white
carton and the shipping carton.

Only return the items which iRT instructs you to return!


For detector models supplied with a separate IQM Mount, if the detector is to be
shipped for service, typically, the mount should be removed and the detector
placed without the mount in the fitted white carton. When the detector has
been detached from the mount, the mount may be used with the IQM Service
Attenuator / Dummy as described in 8.7.

Only ship the separate mount unit when instructed to do by iRT Support.

IQM User Reference Manual (v1.35a SW-v1.8) 8-3


Check the size and shape of the white carton and foam for the detector.
Depending on the carton and foam type it may be necessary to add additional
packing material for a secure fit for the detector, in particular if the mount has
been removed.

8.3 Identifying Detector Serial Number & Software Version


Number
When contacting iRT for assistance, have the serial number of the detector
ready and the software release ID of the IQM software installed.

8.3.1 Serial Number / Control Number


The serial number of the detector may be found on the back label in the white
field UDI (“Universal Device Identifier”) field.

Figure 110 - Location of SN Serial Number field on back of the detector

The UDI contains the serial number. The serial number is


preceded by a character string code “$$+/7” and
followed by a string “/6D….”. Between these string codes
you will find the serial number.

In this example, the serial number is T03061013-07.

Information about how to recognize which software version is currently


implemented follows on the next page.

IQM User Reference Manual (v1.35a SW-v1.8) 8-4


8.3.2 Software Release Information
The release ID of the IQM software may be read by clicking on the “I” info button
in the upper right-hand corner of the IQM Monitor display (here in the red box).

Figure 111 - Click on the “I” button to find the software release ID

Click on the “I” to open the “About IQM Monitor” information box and to see the
release ID for the software.

Figure 112 - Reading the software release ID in the "About IQM Monitor" window

IQM User Reference Manual (v1.35a SW-v1.8) 8-5


8.4 Installing IQM Software Updates
From time to time, iRT may provide updates to the IQM software. iRT may require
that updates are made to the operating system (Windows). Only make updates
to the system after consulting iRT and follow the instructions provided exactly.
Contact iRT for more information.

Do not install other software on the IQM Workstation or Server. If components of


the system are to be installed on hardware shared by other systems (some server
configurations) then the hospital is responsible for verifying the integrity of the
system and the compatibility between systems. Contact iRT for more information.

8.4.1 Mandatory Updates


Upon iRT’s authority and at iRT’s discretion, iRT may make the installation of a
software update mandatory. This may be for the purpose of complying with a
regulatory requirement, for safety or for improved supportability. In this case, the
user is obligated to perform the update and inform iRT once the update is
completed.

8.4.2 System QA & Validation


Recommendations for system QA and validation of the IQM, for example, after
updates or changes in equipment, are found in section 6.6 Periodic QA of the
IQM System.

8.5 Data Backup

8.5.1 Backup of Application Data


The user shall create and maintain a backup copy of the current software
installation (typically located on each computer under C:\Program Files
(x86)\IQM) at a backup location such as on a burned CD, external hard drive
or network directory. It is advised in particular to make a backup copy of the
installed software before a software update is made.

When making a backup copy of the current software installation (either from
server or workstation), it is recommended to perform this task by storing a copy
of the “IQM” folder on the IQM Server, using the following folder structure:
E:\IQM_Data\Support\SW Archive\IQMSERVER\<YYYYMMDD>
E:\IQM_Data\Support\SW Archive\IQMWORKSTATION1\<YYYYMMDD>
E:\IQM_Data\Support\SW Archive\IQMWORKSTATION2\<YYYYMMDD>
...

IQM User Reference Manual (v1.35a SW-v1.8) 8-6


Backups of the database, configuration files and log files are also necessary to
aid in system recovery and in troubleshooting, should problems occur.

The user should therefore maintain a backup of the IQM Server data drive (by
default E:\) where the SQL database backups, configuration files and log files
from the IQM Workstation and IQM Server are stored. By default, backups of
these data are created on a daily basis. See also the section “Implemented
Backup Scheme” for information about backing up these files.

Note: The IQM Server data drive (by default E:\) should be inspected periodically
to evaluate whether there is enough remaining disk space.

8.5.2 Backup of Verification Records


The monitoring results are automatically saved to the IQM internal database.
Therefore, it is recommended that backups of the database be maintained to
ensure that monitoring results may be retrieved as needed in the future. Your
institution may desire (or may be required) to maintain access to these files as
records of the quality assurance measures performed and/or as documentation
that the treatment delivery was within specification. Consult the responsible
persons with knowledge of your institution’s document retention policies to
determine which files should be maintained for which time periods.

Note: The user is responsible for implementing a backup procedure in keeping


with institution’s data protection and retention policy and in keeping with the
requirements of the responsible medical personnel for quality assurance and
verification records.

8.5.3 Implemented Backup Scheme


A backup scheme is implemented during installation to support the user in
backing up the IQM System. The user is responsible to review the results of the
tool and determine whether they suit the insitution's needs, and to ensure that
the tool is working properly.

The installed backup tool is configured to automatically store important


application data as compressed ZIP files at pre-defined locations. Should the
backup scheme, such as location of backup files, be changed, the user should
document any changes made and inform Support about the changes.

The default locations of the configuration files, logs and database backups as
generated by the supplied backup tool are listed below. These files should be
collected and moved regularly to the desired back up location or media as
determined by the responsible user and their institution, either manually or by
implementing a service or script to retrieve and save the files. It is recommended
to retrieve and save the backups daily.

IQM User Reference Manual (v1.35a SW-v1.8) 8-7


8.5.4 Prerequisites for Backup
The backup tool is typically installed on the server as a service, executed as an
administrator user, and is configured to create backup files at the same time
each day. Therefore, it is important that the server and all IQM Workstations as
well as relevant network devices are turned on at the time of backup and that
the network connection between server and the workstations be available,
otherwise the generation of the backup files is not possible.

iRT supplies a script-based solution for back-up. The backup tool will attempt to
execute any missed backup tasks once the computer is (back) on.

8.5.5 Locations of the Backup Files


The backup tool will automatically make backups available as ZIP files. The user
should retrieve these files and save them to the desired backup location or
media.

Typically, the log file and configuration file backups from the IQM Workstation(s)
are made available at the following default folder locations on IQM Server:
E:\WorkstationBackups\IQMWORKSTATION1\Logs
E:\WorkstationBackups\IQMWORKSTATION1\ConfigFiles
E:\WorkstationBackups\IQMWORKSTATION2\Logs
E:\WorkstationBackups\IQMWORKSTATION2\ConfigFiles

Log file, configuration file and database backups from the IQM Servers are
made available at the following folder locations on IQM Server (IQMDBSERVER):
E:\ServerBackups\Logs
E:\ServerBackups\ConfigFiles
E:\ServerBackups\SQL

Note: Backup files should be archived to an external media and removed from
the above locations regularly. If the files are not moved or deleted, the E:\
partition will eventually become full which may impair system performance.

To initiate a backup manually, consult the subchapter “Manual “Full Backup”


below for more information.

IQM User Reference Manual (v1.35a SW-v1.8) 8-8


8.5.6 Automatic Cleanup of Application Data
It is recommended to clean up older back up data.

iRT Support can support users in implementing some clean up tasks. iRT Support
can provide a script-based solution or the user may implement their own
approach. With the default script-based solution, the following application data
are automatically cleaned up every day by deleting the files that are by default
older than 30 days to ensure that disk storage does not fill up. If it is required to
retain data beyond 30 days, ensure that the data are retrieved and stored in an
external backup location.

Note: the exact path(s) may differ at your institution's computers used with IQM.

IQM Server:

• E:\IQM_Data\Logs (IQM application log files)

• E:\ServerBackups\SQL (IQM database backups)

• C:\IQM_Imports\IQM.Failed.Imports
(plan files that failed to be imported)

IQM Workstations:

• As local path: C:\IQM_Data\Logs


As network path: \\IQMWORKSTATION1\Logs
\\IQMWORKSTATION2\Logs

Note: IQM application log files are copied to the Server Backup locations
(E:\WorkstationBackups and E:\ServerBackups, respectively) on a daily basis, as
described in section 8.5.3. Therefore, the original log folders can be cleaned up
without losing data. The database is always appended, that is, only grows, as
there is no function to delete data. Therefore, older database backups can also
be deleted without losing data. The treatment plans that failed to be imported
can be reviewed in the IQM Calculator application log file based on the file
name, so the treatment plans can be safely deleted without losing information.

8.5.7 Manual “Full Backup”


The “Full Backup” task is useful for the purpose of supplying a complete set of
current application data for iRT Support to aid in the resolution of a question or
support issue. The “Full Backup” must be initiated by the user.

IQM User Reference Manual (v1.35a SW-v1.8) 8-9


Consult the "Backup with the iRT Script Solution Guide" or "Backup with Cobian
Guide" for details about making a full back up manually.

8.6 Servicing IQM Measurement Hardware


Service is performed only by trained persons authorized by iRT Systems. Contact
iRT Support if you require service.

Caution:
There are no service tasks intended to be performed by the user
or service staff of the hospital or clinic. Always contact iRT for
service.
Opening the IQM Detector without the express permission of iRT
Support will invalidate the warranty for the device.

The IQM Detector and Transceiver require no service or calibration by the user.
There are no installed components intended to control EMC immunity or
emissions which require periodic replacement or service activities in order to
ensure EMC compliance. See 8.14 End of Service Life & Disposal for information
about general requirements for inspection and refurbishment.

In the event that a service activity, repair or component exchange makes a new
adjustment of parameters or calibration necessary, iRT Support staff performing
the repair will inform the user.

It is recommended that the user compare measurements made before and


after service to confirm that the serviced detector delivers results as expected.
See chapter 6.6 Periodic QA of the IQM System for more information.

The battery in the IQM Detector must be replaced every two years or as
indicated by authorized iRT service staff or service representatives authorized by
iRT. See sections 8.8 through 8.11 for important information about the safe use of
the lithium battery in IQM.

Warning:
High voltage inside! Never open the detector unless explicitly
advised to do so by iRT Support. Always turn off the detector
and disconnect from mains power before attempting to open
the detector.
Do not perform any service task in the presence or proximity of
a patient.

IQM User Reference Manual (v1.35a SW-v1.8) 8-10


Warning:
If this equipment or system is modified, appropriate inspection
and testing must be conducted to ensure continued safe use of
the equipment. This equipment or system shall only be modified
as determined and authorized by iRT.
Only personnel authorized and trained by iRT shall make any
modification or repair to the IQM equipment or system.

Do not attempt repairs or trouble-shooting measurements with the detector


connected to mains power or turned on. Always disconnect the detector from
mains power before opening the device or before any repair or service action.
Do not open the detector unless explicitly instructed to do so by iRT. The detector
may only be serviced by qualified service personnel designated by iRT.

Information for service personnel: Turn off the detector completely before
performing any service activity. If power button only is illuminated (Standby
mode, IQMS only) then push the button for 2 seconds to turn off the detector
completely. The power button and all 4 function LEDs on the front panel should
be off.

The detector is equipped with a DC high voltage generating component


capable of generating 500V. Do not touch the high voltage generator, the
chamber electrode or its related circuits if the detector is on or attached to
mains power, or if you suspect a short circuit, without taking protective measures.
Always follow iRT servicing instructions.

8.6.1 Electrical Safety Testing per IEC 62353


iRT specifies that the user perform electrical safety testing per IEC 62353 every 24
months. National law in your country may specify other time intervals or make
other requirements. Contact your institution’s bio-medical department for more
information.

iRT performs an electrical safety test per the standard IEC 62353 before the IQM
leaves the factory. The test is documented in the Electrical Safety Test Report
and is included in the documentation sent with the system. A copy may be
obtained from iRT Support.

Follow national laws and regulations concerning the testing of electrical safety
of medical devices.

IQM User Reference Manual (v1.35a SW-v1.8) 8-11


8.7 Use of the IQM Detector Service Attenuator / Dummy
The attenuation of the beam caused by presence of the IQM Detector must be
accounted for in treatment planning.

The presence of the detector in the beam path results in an attenuation of the
beam of 5-7% (energy dependent) and this must be incorporated in the TPS
beam model. All fields to be delivered with the IQM Detector in place must be
planned with the attenuation correction taken into consideration. If the IQM
Detector is removed from the beam path for some reason, the user must take
action to ensure that the correct dose is delivered although the detector is not
present in the beam, either by re-planning the treatment plan or by using the
IQM Detector Service Attenuator / Dummy.

Warning:
If a treatment field was planned for delivery with the IQM
Detector in place, and the IQM Detector is NOT in place, the
user must account for its absence by:
a) Re-planning the treatment without the IQM in the beam
model
OR
b) Using the IQM Detector Service Attenuator / Dummy

The coding recognition component of the detector or separate mount


accessory allows the Linac to recognize whether the detector is present or not.
Typically, if the patient plan has been made with the flag set for IQM present,
the Linac control system will expect to “see” the coding presented by the IQM
hardware which indicates that the IQM is present. If the IQM is not present, for
example because it has been removed for service, either the treatment plan
must be recalculated without correction for IQM since the attenuation due to
the IQM is no longer present and a new plan sent to the Linac, OR, the IQM
Detector Service Attenuator / Dummy may be used to continue treatment
without re-planning the patient. If the treatment plan is re-planned, the flag or
setting in the plan must also be removed so that the Linac control system permits
application of the corrected plan without the IQM present. If the treatment plan
is not to be changed, then the attenuator (dummy) is used in place of the
detector. The dummy has the same attenuation as the part of the detector
which is directly in the beam, although constructed differently. Treatment can
proceed without re-planning.

All staff must be instructed and aware that the attenuator component does not
allow measurement or monitoring. It only serves as a convenience to avoid re-

IQM User Reference Manual (v1.35a SW-v1.8) 8-12


planning in the absence of the IQM Detector. The responsible user must
determine which work-around method is better for the department workflow: re-
planning of the treatment plans or use of the attenuator (dummy) in place so
long as the detector is not available.

The IQM Detector Service Attenuator / Dummy is an optional accessory for the
IQM. The service attenuator (dummy) may be purchased or borrowed from iRT
as part of a service order. If your institution does not own a service attenuator
and you wish to use one while the detector is being serviced, contact iRT
Support.

8.8 Replacing the Detector Battery Pack


The lithium ion battery pack in the detector must be replaced by authorized (iRT)
service staff at designated intervals.

The detector must be serviced every 2 years, or as advised by iRT, to ensure that
the battery pack is replaced correctly. Failure to replace the battery correctly,
such as incorrect insertion, may damage the device and may cause a safety
hazard.

Warning:
Danger of Explosion! Incorrect battery insertion may result in
explosion or other safety hazards! Only qualified and trained
service personnel may exchange the battery.
Incorrect insertion by unqualified personnel may result in fire or
explosion which may cause injury or death.

Information for service personnel: Observe the correct position of pin 1 when
exchanging the battery. Incorrect battery insertion may result in explosion or
other safety hazards. Always follow iRT service instructions. If signs of leakage are
observed, see section 8.11.

If iRT determines that the battery must be replaced at an interval shorter than 2
years, the responsible user is obligated to have the battery changed at that time.
Failure to comply may invalidate the product warranty or guarantee.

Contact iRT if you suspect that the battery is not performing correctly, or is
damaged, to arrange for the replacement of the battery.

IQM User Reference Manual (v1.35a SW-v1.8) 8-13


Warning:
Do not attempt to repair a battery pack! Do not dismantle or
disassemble or open the battery pack!

8.9 Proper Handling of Batteries When Device is Not in Use


It is recommended to return the detector to Off mode if the detector is to be
stored for several weeks or longer.

The battery pack should not be allowed to become completely discharged, for
example because of a long period of storage without recharging.

Warning:
Do not allow the battery to become completely discharged. A
completely empty battery may pose a hazard. If IQM is to be
stored and not used for a long period of time, check the battery
every 3 months and recharge if necessary, as described below.

If the IQM Detector must be stored for 3 months or more, then the user should
control the status of the battery charge. Attach the power supply to recharge
the battery pack, preferably to 40% of full charge, before storage, and repeat
the process every three months. Storing the battery when charged to its full
capacity will not damage the battery but storing with a charge of about 40%
may extend the service life of the battery. If the device is left in storage without
recharging for 6-12 month or longer, the battery pack may lose its charging
function.

If you believe that the device has been stored without recharging the battery
pack and has lost its charging function, or the device appears not to function
correctly after long term storage, contact iRT Support for an RMA (Return of
Materials Authorization) to have the device inspected and, if necessary, the
battery replaced.

8.10 Safe Removal & Recycling of Batteries


Should the battery be replaced at the user’s site, the user is required to dispose
of the battery locally, in accordance with local laws for battery disposal. Most
countries require that the battery contact ends be secured for safety reasons,
such as by taping over the ends of the cells. The battery connection wires have

IQM User Reference Manual (v1.35a SW-v1.8) 8-14


connectors which offer correct protection for disposal, do not cut the ribbon
cables or disassemble the connectors!

Used batteries should not be shipped since old batteries may pose a hazard
during transport.

The battery may be removed from the IQM by authorized service personnel by
squeezing the release mechanism on the connector and gently disconnecting
the connector from the printed circuit board.

Contact local authorities for more information and for the location of battery
recycling facilities.

Warning:
Do not cut the battery connection wires! Unprotected wire ends
may cause short circuits which may cause fire or explosion,
resulting in injury or death!
If wires are cut or damaged, secure these by taping each wire
individually so that the wires do not touch each other or any
conductive material present. Contact iRT for more information if
needed.

8.11 Handling Damaged Batteries


If the battery does not function or if you suspect that the battery is damaged,
dispose of the battery locally, in agreement with local laws, anywhere where
batteries are accepted for recycling.

Regulations in most countries require that the battery contact ends be secured
when disposing of batteries to prevent short circuits during collection and
recycling of the batteries, such as by taping over the ends of the cells. The
ribbon cables with connectors offer correct protection for disposal, do not cut
the ribbon cables or disassemble the connectors! If the ribbons or connectors
are damaged, then tape over any exposed wires before disposing of or
recycling the battery pack.

Warning:
Do not crush or puncture batteries! Do not dispose of batteries
by fire – danger of explosion and fire, resulting in injury or death!

IQM User Reference Manual (v1.35a SW-v1.8) 8-15


Note: International law and regulations forbid the transport of damaged
batteries by air and therefore batteries cannot be shipped with most carriers
unless these specifically guarantee ground transport. Additional local laws or
regulations may apply at the user’s location. It is the user’s responsibility to handle
damaged batteries safely and in accordance with law.

Warning:
Shipping damaged batteries by air is strongly prohibited as this
may pose a safety risk. Shipping damaged batteries by air is
contrary to federal law and international regulations.

If there is evidence that a battery has leaked, contact iRT for instructions.

Warning:
If the battery leaks, the electrolyte may cause skin irritation or
burns. Only qualified staff trained by iRT may handle leaking or
damaged batteries. If you suspect leaked electrolyte, use
gloves and other skin protection to avoid any contact and
contact iRT for instructions.

8.12 Housekeeping & Cleaning Recommendations

Warning:
Never spray water or cleaner directly at the equipment. Use only
a dry or barely damp cloth to wipe the exterior surface of the
device if needed. Do not allow water or cleaner to be splashed
or spilled on the equipment. Electrical hazard!
Instruct all cleaning and department staff accordingly.

Warning:
Do not submerge the equipment in any liquid. Do not attempt
to sterilize the equipment. Electrical hazard! Allowing the
electronics to become wet may cause a short circuit or
damage the lithium ion battery and cause a fire or explosion,
resulting in injury or death.

Turn off the device before cleaning it.

IQM User Reference Manual (v1.35a SW-v1.8) 8-16


The device is not for use in a surgical environment and cannot be sterilized. If the
user desires to clean the IQM with a disinfectant, follow the instructions below for
cleaning with water or cleaner. Do not use strong solvents which might damage
the plastic or the protective paint. In any case, do not spray any liquid at the
device!

The IQM Detector and the IQM Transceiver may be cleaned by wiping the
external surfaces with a dry or barely damp cloth. A 30x30cm smooth, lint-free
cotton cloth is suitable. If moisture is desired for cleaning, then spray a little water
on the cleaning cloth, never spray water or cleaner directly at the equipment.
Only use a small amount of water - the cloth should never be so wet that any
water drips out if the cloth is squeezed hard. Be certain that no water drips from
the cloth! Instruct all cleaning and department staff accordingly.

Do not allow any moisture to come into contact with the electronic coding
recognition connector on the detector (IQMS) or the separate IQM Mount unit.
If the coding connector part appears dirty, use a brush or pressurized air spray
to loosen and remove any dirt. Contact iRT if the coding connector still appears
dirty or does not perform as expected.

Do not attempt to insert the cleaning cloth into any openings of the device.
Keep moisture outside of the device.

Moisture or liquids may permanently damage the IQM Detector or IQM


Transceiver and may cause an electrical short circuit. A short circuit may
permanently damage the equipment and may pose a hazard to persons. Do
not allow water or cleaner to be splashed or spilled on the equipment.

If you suspect that the equipment has become wet and moisture has seeped
into the inside of the device, do not use the device until it can be confirmed that
no moisture has entered the device. Contact iRT Support for advice and arrange
to return the equipment to iRT Support for inspection.

8.13 Storage Environment


If the IQM System is to be stored, store at the (room) conditions described in “Use
Environment”.

If the system has been stored or transported under other conditions, allow the
system to come to thermal equilibrium before use. In particular, the use of the
system when colder than the use environment may result in irregular
measurement results. Depending on conditions, 24-72 hours may be required to
achieve thermal equilibrium.

IQM User Reference Manual (v1.35a SW-v1.8) 8-17


The IQM is Medical Electrical Equipment and may not be used if the circuitry is
damp or wet. Damp or wet electrical circuitry will not work properly and is a
shock hazard.

If the IQM System is to be stored for a longer period of time (more than 3 months),
the user must inspect the battery charge level periodically, as described above
in section 8.9.

Store the IQM Detector a flat level surface when not mounted at the linear
accelerator. Do not stack the detector on other equipment or place anything
on top of the detector since this could damage or dirty the device, inhibiting
correct performance.

8.14 End of Service Life & Disposal


The IQM System has been designed and tested for an expected service life of 6
years. After 6 years of use, the equipment should be inspected and updated or
refurbished to allow its continued use. Contact iRT for a quotation and details
about this service.

When taking the IQM System out of service, the owner is required to obey all laws
and regulations concerning waste disposal. Make use of the recycling facilities
in your area. Do not dispose of the device in the municipal trash. See section
8.10 about removing the battery for recycling.

The equipment may be shipped at the user’s expense to iRT for recycling and
safe disposal. Contact iRT for a quotation and for details about this service. Do
not send any equipment without a return materials authorization (RMA).
Unauthorized shipments will be returned at the equipment owner’s expense.

8.14.1 WEEE Statement


The WEEE symbol indicates to all residents of the EU that waste must be disposed
of in accordance with the EC Waste Electrical and Electronic Equipment
Directive (WEEE Directive).

Figure 113 WEEE Symbol

The symbol indicates that the electrical and electronic equipment may not be
disposed of in the trash. The equipment is to be disposed of in conformance with

IQM User Reference Manual (v1.35a SW-v1.8) 8-18


local law, and so that its components may be separated for recycling and to
minimize the negative impact on the environment.

8.15 RoHS Statement


The IQM data acquisition hardware has been manufactured in conformance
with the EU Directive 2011/65/EU, commonly referred to as “RoHS2”. Article 4(2)
in Annex II to RoHS 2 lists the maximum concentration values for 6 materials of
concern. For lead, mercury, hexavalent chromium, polybrominated biphenyls
(PBBs) and polybrominated diphenyl ethers (PBDEs), the maximum
concentration is 0.1 % by weight in all homogeneous materials in the EEE. For
cadmium, the corresponding maximum concentration is 0.01 % by weight in all
homogeneous materials in the EU. All IQM hardware conforms with these
requirements and with the Directive.

IQM User Reference Manual (v1.35a SW-v1.8) 8-19


IQM User Reference Manual (v1.35a SW-v1.8) 8-20
9 IQM Labelling
The IQM data acquisition hardware bear the product labels with important
information for the user.

9.1 IQM Detector

9.1.1 IQM/IQMS Detector – Front

Left: IQM Detector

Below: IQMS Detector

Detailed information about the indicators on the front of the IQM is provided in
section 4.3 Detector Ready and Other Indicators.

Battery Indicator: battery status (various display colors, see 4.3)

Electrometer Polling Indicator: Electrometer (measurement electronics) is


active/not active

Inclinometer Indicator: inclinometer is active/not active

BLUETOOTH Indicator: the BLUETOOTH connection is active/not active

Power Button: The detector is on. In On/Ready for Use mode, the
pushbutton and all other LEDs are illuminated green. In Standby
mode, only the power button is illuminated (IQMS only).
If the pushbutton LED is not on, the detector is in Off mode, ready to
be shipped or stored for longer periods.

IQM User Reference Manual (v1.35a SW-v1.8) 9-1


9.1.2 IQM Detector – Back

Name of this component

Name & address of the manufacturer, iRT Systems)

MANUFACTURED: MM-YYYY Month (MM) and year (YYYY) of manufacture

Indicates that only the original power supply


as supplied by iRT may be used with this
device. See chapter 3.13.

Address of iRT website. Visit the website regularly for


information about IQM

Indicates the country of origin, Germany, where the device


was manufactured

Indicates that this is the back of the device

Plug receptacle label, directly below where the power


supply is connected for charging the battery

The blue “Consult the instructions for use!” symbol informs


the user that it is mandatory to read the instruction manual
because there is important safety information concerning
this piece of equipment which is not obvious or part of the
labelling on the device.

It is mandatory to consult the manual before using this


device.

IQM User Reference Manual (v1.35a SW-v1.8) 9-2


CE marking indicating that the device complies with the
medical Device Directive, followed by the registration
number of the Notified Body

Indicates that the component contains a Lithium ion


battery

Specifications of the power supply. Only the original power


supply as supplied by iRT may be used with this device. See
chapter 3.13.

WEEE symbol indicates to users in the European Economic


Community that this device may not be disposed of in the
municipal trash. When disposing of the device, return it to a
designated collection point for the recycling of waste
electrical and electronic equipment. See the WEEE
statement in chapter 8.14.1.

The FCC Declaration of Conformity symbol indicates that


the electromagnetic interference from the device is under
limits approved by the United States Federal
Communications Commission

Indicates that this equipment is classified as class II electrical


equipment for the duration of time when attached to mains
power supply, during charging

The serial number / control number may also be indicated:


using SN followed by the serial number of the device

Or alternatively as UDI (“Unique Device Identifier”) in


machine and human readable form:

The UDI contains the Product Identifier and the Device


Identifier including the serial number (in some countries:
“control number”) in coded form. See chapter 8.3 for
instructions how to recognize the serial number in the code.

IQM User Reference Manual (v1.35a SW-v1.8) 9-3


9.1.3 IQMS Detector – Back

Name of this component

Name & address of the manufacturer, iRT Systems

This is a medical device

The IFU (user manual) is available in electronic form at


the iRT web address

Indicates the country of origin, Germany, where the device


was manufactured

The device contains a Lithium ion battery

Month (MM) and year (YYYY) of manufacture


MM-YYYY

Indicates that this is the back of the device

Indicates that only the original power supply as


supplied by iRT may be used.

DC power input – connect power supply here

Specifications of the power supply. Only the 15V original


power supply as supplied by iRT may be used with this
device. See chapter 3.13

IQM User Reference Manual (v1.35a SW-v1.8) 9-4


The blue “eIFU indicator - Consult the instructions for use!”
symbol informs the user that the IFU is made available in
electronic (pdf) form, and that it is mandatory to read the
instructions for use because there is important safety
information concerning the equipment which is not obvious
or part of the labelling on the device

WEEE symbol indicates to users in the European Economic


Community that this device may not be disposed of in the
municipal trash. When disposing of the device, return it to a
designated collection point for the recycling of waste
electrical and electronic equipment. See the WEEE
statement in chapter 8.14.1

The FCC Declaration of Conformity symbol indicates that


the electromagnetic interference from the device is under
limits approved by the United States Federal
Communications Commission

CE marking indicating that the device complies with the


medical Device Directive, followed by the registration
number of the Notified Body

Indicates that this equipment is classified as class II electrical


equipment for the duration of time when attached to mains
power supply, during charging

The serial number / control number may also be indicated:


using SN followed by the serial number of the device

Or alternatively as UDI (“Unique Device Identifier”) in


machine and human readable form (in regions where UDI is
required):

The UDI contains the Product Identifier and the Device


Identifier including the serial number (in some countries:
“control number”) in coded form. See chapter 8.3 for
instructions how to recognize the serial number in the code

IQM User Reference Manual (v1.35a SW-v1.8) 9-5


9.1.4 IQM Detector Power Supply

This label indicates to the user that this power supply is for the detector.
Additional information about the ratings for power and for connection the mains
power is given directly on the power supply.

Always use the original power supply as supplied by iRT. Do not confuse the
power supplies.

9.2 IQM Transceiver

9.2.1 IQM Transceiver - Back

Name of this component

Indicates that only the original 5-6V power


supply as supplied by iRT may be used with this
device. See chapter 3.13 for important
information about using the correct power
supply.

All other icons and indicators have the same meaning as on the detector
product label. See above, section 9.1.2.

IQM User Reference Manual (v1.35a SW-v1.8) 9-6


9.2.2 IQM Transceiver Power Supply
This label indicates to the user that this power supply is for the IQM Transceiver.
Additional information about the ratings for power and for connection the mains
power is found directly on the power supply.

Always use the original power supply as supplied by iRT. Do not confuse the
power supplies.

9.2.3 USB to RS232 Serial Cable Adapter

This label indicates to the


user that the USB to RS232
Adapter and the attached
serial cable are for use with
the IQM Workstation, and to
only use the original
adapter as supplied by iRT.

The blue “Consult the instructions for use!” symbol informs


the user that it is mandatory to read the instruction manual
because there is important safety information concerning
this piece of equipment which is not obvious or part of the
labelling on the device.

It is mandatory to consult the manual before using this


device.

IQM User Reference Manual (v1.35a SW-v1.8) 9-7


9.3 IQM Mounts
IQM Mounts are accessories to the IQM Detector (not for IQMS).

9.3.1 IQM Mount for Elekta linear accelerators

Name of this accessory

All icons and indicators have the same meaning as on the detector product
label, described in 9.1.2.

9.3.2 IQM Mount for Varian linear accelerators

IQM Mount
for Varian Name of this accessory

All icons and indicators have the same meaning as on the detector product
label, described in 9.1.2.

IQM User Reference Manual (v1.35a SW-v1.8) 9-8


9.4 IQM Detector Service Dummy

Name of this (optional) accessory

All icons and indicators have the same meaning as on the detector product
label, described in 9.1.2.

9.5 IQM Workstation

The IQM Workstation is


installed in the Linac control
room.

The IQM Workstation is an all-


in-one computer with a
touch screen for user input.

IQM User Reference Manual (v1.35a SW-v1.8) 9-9


9.6 Internal Detector Labels
The following labels are not visible to the user but are inside the equipment and
intended for service personnel.

9.6.1 High Voltage

This warning reminds the service personnel that high voltage may be present. It
is mandatory to follow service instructions and policy when operating the device
with high voltage on for testing during service.

9.6.2 Battery Safety (located on battery pack enclosure)

This warning reminds service personnel of hazards relating to batteries. It also


warns any person attempting to disassemble the device for recycling not to cut
the wires.

9.7 IQM Server


Server hardware supplied by iRT is identified with an IQM Server label.

Additional labelling information is supplied in the accompanying documents


delivered with the server hardware.

IQM User Reference Manual (v1.35a SW-v1.8) 9-10


10 Glossary
Term (English) Description

Acceptance iRT document used during installation, commissioning and


Protocol training to document the installation of the IQM at a
particular Linac at the user’s site, serving as a record of
the on-site system validation in the network environment
Acceptance Test which is conducted at the customer’s site after
Test installation of the system; this test is usually combined
with the user training
Automated When two or more fields from one treatment plan are
Field Sequence grouped together at the Linac console for delivery
(AFS) without breaks or any user interaction between them.
Beam All parameters that are used for comparing the Linac
characteristics performance/delivery against expected parameters,
i.e. dose (aka signal counts) and orientation (aka gantry
& collimator angle)
Calculated The signal calculated by IQM Calculator based on the
Reference treatment plan (expected signal)
Clinical Alarm / Visual and audible indication produced by the IQM
Alarm Monitor software to inform user about a detected
deviation in treatment which requires the user’s attention
and could result in a wrong treatment
Commissioning Activities to measure the characteristics of a specific
chamber and Linac for consideration by the IQM Calc
algorithm
Dynamic IMRT Field is composed of segments in which there may be
jaw and leaf motion while the beam is on, but no gantry
motion
eIFU Electronic IFU (Information for Use)
The electronic (pdf) version of the user manual available
on the IQM Workstation and for download from the
internet, see 1.4
Expected Signal The signal counts baseline which the signal
(also measurement is compared to in verification mode. May
“Reference”) be a Calculated or a Measured Reference.
Field / General type of technique used for Linac treatment, i.e.
treatment type • Non-VMAT / IMRT
• VMAT / Rapid Arc

IQM User Reference Manual (v1.35a SW-v1.8) 10-1


Field Error Special case of System Errors: situation where the IQM
System cannot continue monitoring because of
unexpected data received from the Linac
FIR Filter Finite Impulse Response filtering, applied in IQM to gantry
angles reported by the built-in inclinometer. See “Gantry
Angle Filtering”
Gantry Angle Realtime mathematical processing of IQM’s inclinometer
Filtering readings with a “Finite Impulse Response” algorithm to
remove noise from “bouncy” gantry readings, frequently
seen at start and stop of gantry rotation and when
changing gantry speed.
Interrupted Field A treatment where the Linac is stopped unexpectedly
during the delivery and broadcasts a “FieldEnd” event
and “MU delivered so far” value. (This might happen if
the patient is nauseous or if the Linac has a service issue,
so the treatment has to stop for a while)
Inter-segment Between two segments – IQM evaluates each segment
vs. intra- after its completion (inter-segment), not during segment
segment delivery (intra-segment)
IFU Information for Use - user manual, see also eIFU
IQM Name of the medical device as a whole
IQMS, IQMS IQM Slim – slimmer, low profile variant of the IQM
Detector
IQM Calculator Component of IQM: Software application that imports
(aka Calc) Dicom RT Plan files and calculates Reference signals
IQM data Comprises all hardware components of the medical
acquisition device: IQM/ Detector, IQM Transceiver, IQM Mount for
hardware detector (accessory to the detector) and their
components (excludes any computer hardware)
IQM Detector Component of IQM: measuring device attached to the
Linac
IQM hardware Comprises all hardware components of the medical
device: IQM Detector (also IQMS variants), IQM
Transceiver, IQM Mount for detector if supplied
(accessory to the detector) and their components
(excludes any computer hardware)
IQM Monitor Component of IQM: software application that records
measured IQM signals, compares them to Reference
Signals and issues alerts and alarms when applicable;
also monitors the state of the detector and
communication with the Linac and database. Installed
at the IQM Workstation

IQM User Reference Manual (v1.35a SW-v1.8) 10-2


IQM Mount An accessory to the detector. (Not applicable for the
IQMS variant). Part fixed to the IQM Detector to attach it
to the Linac, the mechanical interface to the collimator
head of the Linac (also "holder" or "adapter")
IQM Reporter The IQM Windows service that automatically generates
reports for Calc and Monitor and provides optional
report distribution by email
IQM Review Component of IQM: software application to review the
measurements and results as recorded and evaluated
by IQM Monitor
IQM Server Computer installed in the RT department network;
location of the IQM Database
IQM System See “IQM”, i.e. all components that are part of IQM
IQM Transceiver Component of IQM: part of the data acquisition
hardware installed in the treatment room on the wall,
receives measured data from the detector component
by BLUETOOTH and sends these via cable to the IQM
Workstation
IQM Workstation Workstation (computer) which runs the IQM Monitor
(aka control application, located in the linear accelerator control
unit) room
Linac linear accelerator
Measured The signal recorded by IQM Detector in a previous
Reference treatment/session; used as the expected signal for
comparison with subsequent deliveries of the same plan
Near-realtime During beam delivery - comparison results of expected
results and measured data are available as soon as
information is provided by the Linac, i.e. at the end of a
field
Non-VMAT Summarizes the treatment types StepNShoot IMRT,
(“IMRT”) Dynamic-IMRT, and static fields
Paused Field A treatment where the Linac is suspended by the
operator or interlock during the delivery but continues
without broadcasting a “FieldEnd” event and “MU
delivered so far” value. (This might happen if the patient
shifts and needs to be re-positioned, or if a Linac
interlock occurs but is cleared)
Realtime results During beam delivery - comparison results of expected
and measured data are available within a time frame
where the user is able to react to prevent the patient
from being harmed, i.e. within 2 seconds of the end of a
segment

IQM User Reference Manual (v1.35a SW-v1.8) 10-3


Reporter See “IQM Reporter”
RT Radiotherapy, Radiation Therapy
Segment A beam segment is spanned by two consecutive control
points. IQM only considers segments where the beam is
on, so the sequence of segment numbers for IMRT is
usually [1, 3, 5, …] (odd numbers) because [2, 4, …] are
move-only segments. For VMAT, the sequence is [1, 2, 3,
…] because the Linac moves and delivers beam in all
segments.
SbS Segment by Segment
Session All fields delivered for a single patient in a single block of
time; used to group delivered fields for reports. A delivery
session ends when a new patient is loaded or when the
Monitor application is closed.
Static field Field has only one segment, no motion during the
segment
StepNShoot Also “Step and Shoot”
IMRT Field is composed of segments in which there is no
motion while the beam is on
System Alert Indication of a System Error or System Warning in
(Functional software using color, text and/or sound to attract the
Alert, user’s attention. The intensity depends on the severity of
Operational the situation
Alert)
System Error Indication of problems that prevent the system from
functioning correctly or continuing its function, such as
loss of network connectivity, missing or incorrect
configuration files or values, or hardware failures
System Warning Indication of problems that may prevent the system from
functioning correctly in the future, such as intermittent
network connectivity or a room temperature above the
normal range
Treatment Used interchangeably to mean linear accelerator.
machine Also ‘Machine’
Treatment The IQM Signal (counts) measured by the IQM Detector
Record device during the current treatment session (fraction or
Measured QA measurement)
Signal
Turnaround When a planned field includes multiple overlapping arcs,
Points the specific angles at which the gantry changes direction
Unexpectedly A treatment where the Linac is stopped unexpectedly in
Terminated an abrupt “untidy” manner and does not broadcast a
Field “FieldEnd” event. (This might happen if the Linac control

IQM User Reference Manual (v1.35a SW-v1.8) 10-4


console failed, or if it lost connectivity to the Linac or
broadcast system.) In this case IQM does not “know” the
MU delivered so far and may not be able to close and
evaluate the segment that was being broadcast when
the Linac stopped
VMAT / Rapid Field is composed of segments in which there may be
Arc jaw, leaf, and gantry motion while the beam is on. The
term
VMAT is used in association with Elekta machines and
Rapid Arc for Varian treatments of this type
Watch Event Visual indication produced by the IQM Monitor software
to inform the user about a detected deviation in
treatment which is outside normal delivery variation but
which is sufficiently insignificant to be investigated at a
later time

IQM User Reference Manual (v1.35a SW-v1.8) 10-5


IQM User Reference Manual (v1.35a SW-v1.8) 10-6
11 List of Tables
Table Number & Label Page Number
Table 1 - Colors and Meanings of LED Indicators on the IQM 4-9
Detector

Table 2 - Status Indicator Fields 4-33

Table 3 - Conditions for Clinical Alarms 4-45

4-46
Table 4 Conditions for Clinical Alarms – Signal Deviations
(Varian Static/IMRT fields only)

Table 5 Other Conditions for Clinical Alarms 4-47

Table 6 – Messages for Field Error Dialogs 4-51

Table 7 - Dicom-RT Plan Tags Required by IQM 6-35

Table 8 – Linac Communication Errors shown at Startup 6-54

Table 9 - Linac Connection Configuration Errors shown at 6-55


Startup, Typically Requiring User Intervention

6-57
Table 10 - Detector Communication Errors shown at Startup

Table 11 - Detector Configuration Errors shown at Startup 6-58

IQM User Reference Manual (v1.35a SW-v1.8) 11-1


IQM User Reference Manual (v1.35a SW-v1.8) 11-2
Appendix 1 - System QA & Validation
Various tests are made during installation and commissioning of the IQM System
in order to validate the functionality of the system in its particular clinical and
network context. These or other tests are suitable for repetition as quality
assurance measures or for validation of system behavior, for example after
updating or adding systems in/to the network. Tests made during installation
include reproducibility, linearity, dose rate dependence and the QA Field Test.
The QA Field Test is described here as an example; the user is encouraged to
design their own test fields and to develop their own test criteria.

1.1 QA Field Test


An IQM QA test field consists of an IMRT plan with eighteen segments, seventeen
4 cm x 4 cm segments at different off-axis locations, and one axial 10 cm x 10
cm segment. For some collimators a different plan might be necessary (see
below for an example). The intention of the QA Field test is a quick combined
evaluation of the IQM performance and the Linac. If both the systems are in their
reference operating conditions, then the QA field results (raw values, as well as
normalized values) should show a consistent increasing/ decreasing variation in
the gradient direction, and symmetric values in the non-gradient direction.
As for the symmetric values in the non-gradient direction, the agreement
(tolerance) between the identical fields (fields with same distances from the mid-
line) should be well within +/- 3% (this tolerance includes 1% variation of IQM
chamber sensitivity and 2% variation in beam symmetry). If the machine is strictly
in its reference condition, then this tolerance could be narrower.
The figures below demonstrate the beam location of each segment for a
standard collimator and the Varian HD MLC120 as an example for how the test
field can be adapted to better capture the characteristics of a particular
collimator configuration. The sequence of the segments is indicated by the red
number at the bottom of each open area. Segment 1 and 2 are the central 4x4
and 10x10 respectively.

Modality/Energy Photons/All used Energies (at minimum for 6 MV)

Segment Sizes For standard collimators:


17x 4x4cm and 1x 10x10cm (defined by MLC and Jaws)
For Varian HD MLC120:
15x 4x4cm and 1x 10x10cm (defined by MLC and Jaws)
Dose Output 50 MU/Segment

IQM User Reference Manual (v1.35a SW-v1.8) A1-1


1.2 General Example Applicable for Most Collimators

E.g. 6MV QA Field Test: The number in each box is the typical IQM signal factor
normalized to the axial 4 cm x 4 cm segment.

When designing test fields, consider the characteristics of the Linac being
monitored, such as the over travel characteristics of the X and Y jaws, and the
relation of MLC positions to the shielding / jaws behind the MLCs (the extent to
which the collimators close behind the MLC in the X and Y direction may be
different).

IQM User Reference Manual (v1.35a SW-v1.8) A1-2


1.3 Example for Varian HD MLC120 Collimator

The different arrangement of segments (15 x 4 cm X 4 cm segments, and the 10


cm x 10 cm segment) is based on the following limitations of the Varian HD
MLC120 compared to other collimators:

Maximum static field size: 22 cm x 40 cm


Maximum static aperture field size: 22 cm x 30 cm
Maximum IMRT field size: 22 cm x 32 cm
There is a limitation on total number of MU assigned to an IMRT field. This
parameter is configurable, and may vary from accelerator to accelerator.
Additional constraints for the Varian HD MLC120 to consider in using the QA Test
Plan or when designing your own test fields:

1. X jaws can only over travel center by 2cm


2. Y jaws can over travel by 10cm
3. MLC in direction of motion can travel 15cm beyond shielding X jaw, but
4. only 22cm of MLC perpendicular to leaves (Y direction)

IQM User Reference Manual (v1.35a SW-v1.8) A1-3


IQM User Reference Manual (v1.35a SW-v1.8) A1-4
Appendix 2 - EMC Declarations per IEC 60601-1-2, 3.0
The IQM System has been tested to the EMC standard for medical devices IEC
60601-1-2 in the 3rd and 4th editions whereas the IQMS variant was tested with the
current 4th edition only. The declarations in accordance with the 4th edition are
found in chapter 7 EMC Declarations. Specifically, Tables 2 and 4 reflect the test
requirements of 3rd edition.

If you have questions about EMC declarations per IEC 60601-1-2, edition 3.0
(the previous version of the standard) please contact Support.

IQM User Reference Manual (v1.35a SW-v1.8) A2-1


Appendix 3 – Recommendations for Training
User training is part of the IQM installation & commissioning process.

Important information for safety is presented during training. Staff members who
were not present during training at the time of installation should be trained
before they use the equipment, either by a designated responsible user
designated by the hospital or by iRT.

For example, new radiation therapists must be shown how to attach and detach
the detector and instructed about the importance of having the detector in
place if a treatment has been planned with the correction for detector beam
attenuation. All users must be instructed how to recognize if the system is
available for monitoring, and the cleaning staff advised not to spray water into
or at the measurement device, etc.

Contact iRT Support for more information about receiving additional training
from an iRT Support Specialist. Training for medical physicists and radiation
therapists may be combined or made separately by user group. Designated
responsible users who conduct training in their departments are welcome to
contact iRT Support for advice concerning the content of internal department
trainings.

IQM User Reference Manual (v1.35a SW-v1.8) A3-1


Appendix 4 – Recommendations for Safety Check per
IEC 62365
This appendix has been removed.

Information about safety tests per IEC 62353 are now located in chapter 8.6.1.

IQM User Reference Manual (v1.35a SW-v1.8) A4-1


Appendix 5 - Dose Output Correction Factor & DOC
Factor Editor

1.1 Dose Output Correction (DOC) in IQM


IQM offers the user an optional method of applying a correction to measured
signals to account for a known daily dose variation. Treatment machine output
varies day to day, and depending on the linear accelerator, many institutions
routinely expect up to 2% or 3% variation. Some users observe variation in output
which presents itself as a consistent offset to the known calibration conditions.
For example, with a +2% output variation measured during Daily QA, even if
there are no delivery deviations, the measured IQM signal for every field that
day will be about 2% high. Conversely, if the Daily QA showed that the output
was -1% (low), the measured IQM signal for every field would be 1% low without
any other delivery deviation occurring. To address this, the department can
either implement wider watch and action limits for signal verification or normalize
this known variation out of the measured signal by implementing a DOC factor
as described here.

The Dose Output Correction (DOC) Factor (or “DOCF”) is a normalization factor
(or divisor) that is applied to measured values to account for day-to-day
variation in machine output. The DOCF value may be updated regularly (daily)
based on a selected field monitored by IQM and compared against a stored
reference for that field. Alternatively, the factor can be calculated with data
from the department’s daily QA output check.

Each DOCF value is specific to a particular Linac for a particular energy and is
stored in the IQM Database. The DOCF value is initially 1.0 (neutral value, does
not have an effect).

If a DOCF value is set at the time that a field is monitored with IQM, the measured
IQM signal values shown in Monitor and later in Review will include the
normalization, and the DOCF value applied is shown onscreen and indicated on
generated reports. The measured signal values are saved in the IQM Database
as un-normalized signal values together with the DOCF value that was applied
during monitoring.

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Daily measurements with IQM can aid in making a trend in machine output more
visible and trackable. Applying a correction factor for a given day’s
measurements “normalizes out” a defined quantity of variation in an absolute
direction. The user should carefully evaluate the usefulness of any factor applied,
and be aware that normalizing for an expected offset will have the intended
effect of making that amount of variation captured in the DOC factor not visible,
or differently visible, in monitoring.

Caution:
Only knowledgeable, authorized users should implement or
change a DOC factor. The usefulness of the DOC factor will
depend on how well the DOC factor reflects a systematic
deviation in the output of the treatment machine and the user’s
approach to analyzing and using the presented results.

1.2 Specifying the DOC Factor


The DOC factor is based on two measurements and mirrors the absolute dose
output measurement or dose output constancy check performed during Daily
Machine QA.

The same QA field used for daily output verification can be used for deriving the
DOCF value for IQM. When using the same QA field, the Daily machine QA and
IQM DOC factor reflect the same data.

Many institutions will use a 100 MU 10x10 cm2 field at the central axis, but if a
different field is routinely used for measuring and evaluating machine output,
that field can be used to calculate the daily DOC value.

The measurements may be made with the IQM or with other QA or absolute
dosimetry systems.

The DOC factor can be derived from:

• A daily measurement taken with the IQM Detector and a reference


measurement also taken with the IQM Detector
• A daily measurement taken with the IQM Detector and a calculated
reference value computed by IQM Calculator
• A daily measurement taken with another QA device or absolute dose
measurement solution system and a reference measurement also taken
with the QA device or absolute dose measurement solution

If using daily and reference measurements taken with the IQM Detector, the
reference measurement should be one acquired during IQM commissioning or
on another day when the machine was known to be well-calibrated.

IQM User Reference Manual (v1.35a SW-v1.8) A5-2


Similarly, if using another QA device or an absolute dosimetry system, the
reference measurement should be one from your most recent machine
calibration, or otherwise correlating with calibration conditions.

The DOCF value is calculated as


𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑚𝑒𝑛𝑡𝑐𝑜𝑟𝑟
𝑑𝑜𝑐𝑓 =
𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑚𝑒𝑛𝑡𝑟𝑒𝑓

where measurementcorr is the measurement taken on the day of interest (corrected


for temperature and air pressure, if applicable) and measurementref is the
reference measurement taken under calibration conditions.

With this calculation, DOCF values larger than 1.0000 indicate higher than
expected machine output.

When to update the DOC Factor


The DOC factor is an option available to the user and is to be applied at the
user’s discretion. If DOC factors are applied, it is recommended to measure and
inspect whether the active DOC factor remains valid. In particular, it is
recommended to verify the applicability of the DOC factor after calibration of
the linear accelerator or major service. As a general rule, any change in dose
output which requires an update of the dose output as implemented in the TPS
will indicate that a new reference measurement made at the new calibration
conditions is needed for deriving the DOC factor, regardless of whether the
measurements are made with the IQM or other QA or absolute dosimetry system.

1.3 Using the DOC Factor Editor


IQM provides a software application, the DOC Factor Editor, to set the DOC
factor. Start the DOC Factor Editor by clicking its shortcut on the Desktop.

The DOC Factor Editor allows immediate application of the defined DOC factor
in subsequent monitoring. If the DOC factor is updated during a field delivery,
that field delivery will not be impacted but the new DOC value will be applied
to the next monitored field. The DOC factor is used to normalize the measured
data and will have a direct impact on how the measured signal is presented
and evaluated as within tolerance or as at ‘watch’ or ‘action’ (clinical alarm)
level.

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Caution:
Only knowledgeable, authorized users should implement or
change a DOC factor. The DOC factor is used by IQM to
normalize the measured values and will impact which values will
be evaluated as within expected tolerances or within the
‘watch’ or 'action’ (clinical alarm) range.
Inform staff about the department policy concerning who is
authorized to implement DOC factors and how these are to be
derived.

The Editor loads with the currently active linear accelerator highlighted to show
that it is selected. The available energies for the selected accelerator are listed
at the right in the main panel with their current DOC factors. Select another
machine on the list at the left to review the current DOC factor for its
commissioned energies.

There are two ways to update the DOC factor: to manually enter the desired
factor, or to enter a reference IQM signal value and today’s measured IQM
signal value for the same field and let the DOC Factor Editor calculate the factor
automatically.

To change a DOC factor, select the relevant treatment machine and energy
combination. The selected energy and its DOC factor will be shown in the
“Change DOC Factor” tab (middle of the display).

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Select
energy to
edit here

Currently selected energy


Currently and DOC factor for it
selected
linear
accelerator
is highlighted

Figure 114 - Editor showing several linear accelerators (selection list on the left) and the energies
associated with the currently active linear accelerator, with their current DOC factors (main panel
on the right).

Proceed with 1.3.1 to let the DOC Factor Editor derive the factor or enter a
calculated factor directly by hand as described in 1.3.2.

Calculating the DOC Factor from Reference and Measured


IQM Signals
The DOC Factor Editor may be used to derive a calculated DOC factor from
IQM signal measurements. A reference measurement at calibration conditions
is required together with a measurement from the day/time for which the DOC
factor is to be derived.

If an IQM measurement is taken every morning as a consistency check on


treatment machine dose output, this same measurement may be used to
calculate the day’s DOC factor.

IQM User Reference Manual (v1.35a SW-v1.8) A5-5


The reference measurement used for this dose output consistency check should
have been acquired during IQM system commissioning, or on another day when
the linear accelerator was known to be well calibrated.

Enter the IQM Signal Counts value from this reference measurement, then
today’s measured value for the same delivered field.

Figure 115 – The DOCF Editor may be used to derive the DOC factor from reference and measured
IQM Signal Count values from the day of interest

The editor will calculate the ratio of these two signal measurements and
automatically display the resulting DOC factor below them. To use this
calculated DOC factor, click the “Continue with Calculated Factor” button.

The calculated value will be populated into the “New DOC Factor” field directly
below this calculation area.

Entering the DOC Factor Manually


The user may calculate the DOC factor using another method and the
measured values from another daily QA measurement, whether acquired with
another daily consistency checking device or an absolute measurement. In this
case, the resulting DOC factor should be typed directly in the “New DOC Factor”
field below the calculation area.

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Saving the New DOC Factor
Click “Save DOC Factor” to apply the new DOC value as it appears in the box.

Figure 116 - Click "Save DOC Factor” to update the DOC factor value for the selected machine
and energy. The Save button will not be enabled unless the entered value is in the range from
0.9700 to 1.0300 and a reason or source for the change in value is listed.

Note that by default the DOC factor entered must be in the range from 0.97 to
1.03 (equivalent to +/-3%) and a note about the reason or source of the DOC
factor change must be entered before the “Save DOC Factor” button will be
enabled.

The system can be configured to accept DOC factors outside of the default
range of 0.97 to 1.03 (+/-3%). If a DOC outside of the default range is desired,
contact iRT Support for instructions how to implement a different range.

A confirmation dialog appears.

Figure 117 - Update DOC factor confirmation dialog

Check that the DOC factor is correct for the machine and energy combination
shown and click “Yes.”

IQM User Reference Manual (v1.35a SW-v1.8) A5-7


The DOC Factor Editor will now show the updated DOC value for this energy.

Updated DOC
factor for the
selected linear
accelerator

Figure 118 – DOC Factor Editor with updated value for 6 MV

IQM User Reference Manual (v1.35a SW-v1.8) A5-8


Reviewing Past DOC Factors
Past DOC factor values with corresponding data (reference signal, measured
signal, reason/source information) for the selected linear accelerator and
energy can be reviewed in the ‘History’ tab in the middle of the display, next to
the ‘Change Doc Factor’ tab.

Figure 119 – the ‘History’ tab shows all DOC values set for this machine, up to and including the
current DOC factor

DOC factor update after upload of a new machine


configuration file
When a new machine configuration file is uploaded to the database (see
chapter 6.5), for example after commissioning of a new energy, the DOC Factor
entries for this machine are automatically reset to 1.0.

When selecting the respective machine in the selection tree of the DOC Factor
application (see Figure 114) for the first time after the machine configuration file
was uploaded, a dialog appears, asking the user whether the DOC Factor
values for the previous machine version shall be applied to the new machine
version (Figure 120).

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Figure 120 – Dialog for adopting DOC Factor of previous machine version

If the user confirms with “Yes”, the previous DOC factor values are applied to the
new configuration and both the DOC Reference and the DOC Measurements
for calculating the DOC factor value will be available for the new machine
version for all energies in the DOC factor application.

If the user cancels the prompt with “No”, the default DOC factor value 1.0 is kept
and no dose output correction will be performed for the machine. In this case,
the “Reason/Source” entry ("Initialization") in the upper table in the main
window, is updated to record that the user chose to not take over the values
from the previous version.

If the user closes the dialog via the close button (x), the dialog opens again the
next time the machine is selected in the DOC factor application.

1.4 DOC Factor Handling in Monitor


If a DOCF value is currently specified for the machine and energy being used to
deliver the monitored beam, that DOCF is applied to the measured signal values
for each segment and shown onscreen in Monitor. The values shown in the
graphs and table reflect the normalization of the values using the DOC factor.

The measured signal values are saved in the IQM Database as un-normalized
signal values together with the DOCF value that was applied during monitoring.

1.5 How IQM Applies the DOC Factor in Monitor


The DOCF is applied to the measured (and corrected for temperature and
pressure) signal for a segment to get the normalized measured signal:
𝑠𝑖𝑔𝑛𝑎𝑙𝑐𝑜𝑟𝑟
𝑠𝑖𝑔𝑛𝑎𝑙𝑑𝑜𝑐 =
𝑑𝑜𝑐𝑓

For example: The measured signal (𝑠𝑖𝑔𝑛𝑎𝑙𝑐𝑜𝑟𝑟 ) is 1020. The docf is 1.02. The value
for 𝑠𝑖𝑔𝑛𝑎𝑙𝑑𝑜𝑐 is calculated as 1020/1.02 = 1000.

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Displaying the Applied DOC Factor Value in Monitor
IQM will display the current DOC factor in the Status Block area with the label
“DOC Factor Applied:”

Figure 121 - Status area showing DOC factor applied

In the (rare) case that not all segments in a monitored field share the same
nominal energy, the ‘DOC Factor Applied’ is displayed as “Multiple” to indicate
that two or more different DOC factors were applied to the individual segments,
based on their nominal energy.

Figure 122 - Monitoring status area showing that two or more different DOC factor values were
applied to individual segments based on their nominal energies

The DOC factor is also applied and displayed in Record mode.

The DOC factor is not applied in Display Mode because in the absence of a
treatment plan there is not enough information about the treatment machine
and energy available to IQM.

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1.6 DOC Factor Presentation in Reports
If a DOC factor was applied during monitoring, the Treatment Reports
generated for that monitored delivery will include the DOC factor for each field
in the ‘Field Overview’ and ‘Field Details’ sections.

The Excel treatment reports include the DOC factor value applied to each
individual segment.

Example Report: Field Overview

DOC factor for the


field; says “Multiple”
if more than one
value was applied

Figure 123 - Field Overview in Treatment Report showing the DOC Factor applied during monitoring
for each field

IQM User Reference Manual (v1.35a SW-v1.8) A5-12


Example Report: ‘Field Details’ Section

DOC factor for the


field; says “Multiple” if
more than one value
was applied

Figure 124 - Field Details section in Treatment Report showing the DOC Factor applied during
monitoring

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1.7 DOC Factor Display in Review
If a DOC factor was applied during monitoring, the ‘Signal Measurement Record
Notes’ area at the bottom of the screen in Review will include a message stating
that fact and the value of the DOC factor applied during monitoring.

Figure 125 – ‘Record Notes’ area in the Review application including note that a DOC factor was
applied to all segments in the field and stating its value

In the (rare) case that not all segments in a monitored field share the same
nominal energy, the message in the ‘Signal Measurement Record Notes’ area
indicates which different DOC factors were applied to which specific segments.

Figure 126 – ‘Record Notes’ area in the Review application including which DOC factor values
were applied to which individual segments in the field, for the case that not all segments share the
same nominal energy

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IQM User Reference Manual (v1.35a SW-v1.8) A5-15

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