Professional Documents
Culture Documents
IQM User Reference Manual V1.35a - SW-v1.8
IQM User Reference Manual V1.35a - SW-v1.8
iRT Systems
Schlossstrasse 1, 56068 Koblenz, Germany
www.i-rt.de
Copyright & Disclaimer
This device bears the CE mark in conformance with the European Medical
Device Directive
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
Please contact iRT to request a DoC for a specific regulation or market if desired.
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
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").
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.
Caution:
IQM can only monitor field deliveries for which the
corresponding treatment plan has been imported to the IQM
database.
More information about the symbols and information on the product labels can
be found in section 9 IQM Labelling.
“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").
“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.
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
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.
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.
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.
Figure 1 - The IQM consists of items defined as MEE medical electrical equipment
and other required items which are not defined as MEE
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 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.
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.
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.
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.
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 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.
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 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 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.
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.
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.
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.
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.
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.
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.
Warning:
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.
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.
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.
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.
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.
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.
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.
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:
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).
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
If the user institution has implemented a wireless network with safety controls
which permit sending patient data over the wireless network securely in
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.
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 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.
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.
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.
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)
Once the IQM Workstation is installed, these cables should remain connected.
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.
The computers used to run the IQM Review application to review monitoring
results and create reports should fulfill the following requirements:
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.
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.
Security Groups:
Users:
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.
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.
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
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.
The IQM Monitor application displays information about the gantry angle and
the collimator rotation in the “Planned Geometry” Group using the IEC
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 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.
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
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.
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.
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.
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.
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.
The transceiver communicates with the IQM Detector wirelessly using the
BLUETOOTH standard, and with the IQM Workstation via an RS232 serial cable.
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
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.
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)
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.
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.
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.
If the IQM Transceiver has been turned off, flip the switch on the bottom of the
unit to turn on the transceiver.
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.
For information about how to charge the detector, see section 4.13.
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.
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).
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 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.
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.
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: 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.
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 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.
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.
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!
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.
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).
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.
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.
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.
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:
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.
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.
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.
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.
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.”
If desired, click “Stop sound” to turn off the audible alert while you complete the
test:
Adjust the
speaker
settings
• Confirm that the alarm can be heard by selecting “I can hear the alarm”
and selecting ‘Finish’.
If you hear it, select “I can hear the alarm” and click ‘Finish’ to complete
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.
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.
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.
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
A B C
D F
E G
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.
The left panel indicates the Field ID (also referred to as “beam name”) last
broadcast by the Linac control system.
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.
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.
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.
In each graph, segments that are not delivered as expected are shaded:
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.
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.)
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.
• 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.
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.
More information about the Progress Bar is found in Section 4.14.1 “Progress Bar”
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.
Figure 44 - Status indicator area with Dose Output Correction and Background Signal Correction
enabled
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.
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.
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:
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.
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.
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.
When a new patient and field are loaded at the Linac console, IQM
automatically loads the new patient and field and monitors the treatment.
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
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”).
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.
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
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.)
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.
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.
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.
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
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.
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.
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.
Measured signal: X
Signal deviation: Y%
Applied action level: +/- Z %
Measured signal: X
Signal deviation: Y%
Action level: +/- Z %
Message Code:
FieldPerSegmentDeviationAlarm.Realtime
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 %
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.
Message Code:
FieldCumulativeDeviationAlarm.Concluded
Gantry angle: Y°
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 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 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).
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.
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: 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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
• 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.
If beam pauses appear not to be recognized and handled by IQM, the user
should contact Support so that the settings can be verified.
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.
If the “Too Many Fields” error is seen, the user should consider waiting briefly after
field delivery before moding up the next field.
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.
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"
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 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.
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.
Choose a patient by clicking its Patient Name or ID and then clicking “Open.”
Alternatively, double-click on the patient record.
1 2 3 4
5 9 8
10
11
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
Only records for the same field delivered with the same Linac and IQM Detector
can be overlaid and compared to one another.
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
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.
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.
Checking the box next to a record displays it in the graphs and segment table.
The color bars to the right of each selected record identifier in the selection tree
show the color in which each record is graphed.
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.
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.
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.
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.
Figure 70 - Selected treatment record shown against a Measured Reference record with
Tolerance, Watch and Action corridors in the Cumulative graph
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
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.
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.
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.
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 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.
(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.
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.
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.
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.
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
Information about IQM Reporter can be found in the IQM Reporter Extension for
IQM - User Manual.
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.
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.
Rule classification
Example:
DynamicIMRT.Calc.Watch.Cumulative.Short = 2.0
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.
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.
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.
As per the definition, the Action Level values must be greater or equal than the
Watch Level values.
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.
Figure 84 shows the resulting constant course of values for the above-mentioned
rule for the first 10 beam segments.
• 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
• 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.
Note: the segment indices that define ranges are further explained below the
following example.
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
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)
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.
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
Figure 86 – Graph labelling and values for Cumulative Rule Example – StepIMRT
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
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%.
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).
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.
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
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
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.
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.
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.
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.
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%”.
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.
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.
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
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.
These segment groupings are always applied before any optional merging or
averaging rules are applied.
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.
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).
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.
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.
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.
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.
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
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.
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.
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.
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.
The example from section 6.1.2.4 is modified such that the Action Level NA Rule
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 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).
Note: FIR Filtering will not generally improve results for VMAT arcs that start in a
blind arc region, near 0˚ and ±180˚.
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.
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
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.
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:
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.
Please see sections 8.6 Removing the IQM Detector for Service and 8.7 Using the
IQM Service Dummy for more information.
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.
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: 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.
Example:
[AppSettings]
MachineName = EM01
SystemSerial = 0302101301
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:
Elekta ICom
LinacAssemblyName = Linac4.ElektaICom /LAG=100
SysconAssemblyName = Syscon4.DevCon4
LinacConnectString = 168.1.1.10
SysconConnectString = COM1
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.
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.
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.
Remarks:
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:
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.
Default settings:
[AppSettings]
PlanImportDir = C:\IQM_Imports
CalcMode = Full
CalcInterval = 60000
CalcThreads = 1
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.
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.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”.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
𝑛,𝑚
𝑁𝐼𝑄𝑀
= 𝑈 ∙ 𝐴𝑂𝐹(𝑓𝑖𝑒𝑙𝑑𝑠𝑖𝑧𝑒) ∙ ∙ ∑ 𝑆𝐼𝑄𝑀 (𝑖, 𝑗) ∙ ((1 − 𝑓𝑆 )𝐼𝑃 (𝑖, 𝑗) + 𝑓𝑆 𝐼𝑆 (𝑖, 𝑗))
𝑛×𝑚
𝑖,𝑗
where
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.
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
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
a)
b)
xSS′,ySS′
dIQM
xd′,yd′
𝑛 × 𝑚 ∙ 𝐶𝐼𝑄𝑀 (𝑟𝑒𝑓)
𝑁𝐼𝑄𝑀 = .
𝑈 ∙ ∑𝑛,𝑚
𝑖,𝑗 𝑆𝐼𝑄𝑀 (𝑖, 𝑗) ∙ 𝐼(𝑖, 𝑗)
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)
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
Figure 108 - An example of an AOF table derived from a series of rectangular field
measurements.
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.
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.
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.
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 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
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)
710
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
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.
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.
Only ship the separate mount unit when instructed to do by iRT Support.
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
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>
...
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.
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.
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.
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.
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:
• C:\IQM_Imports\IQM.Failed.Imports
(plan files that failed to be imported)
IQM Workstations:
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.
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.
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.
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.
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
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-
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.
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.
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.
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.
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!
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.
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.
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.
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.
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.
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.
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.
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
Detailed information about the indicators on the front of the IQM is provided in
section 4.3 Detector Ready and Other Indicators.
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.
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.
All other icons and indicators have the same meaning as on the detector
product label. See above, section 9.1.2.
Always use the original power supply as supplied by iRT. Do not confuse the
power supplies.
All icons and indicators have the same meaning as on the detector product
label, described in 9.1.2.
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.
All icons and indicators have the same meaning as on the detector product
label, described in 9.1.2.
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.
4-46
Table 4 Conditions for Clinical Alarms – Signal Deviations
(Varian Static/IMRT fields only)
6-57
Table 10 - Detector Communication Errors shown at Startup
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).
If you have questions about EMC declarations per IEC 60601-1-2, edition 3.0
(the previous version of the standard) please contact Support.
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.
Information about safety tests per IEC 62353 are now located in chapter 8.6.1.
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.
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.
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.
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.
With this calculation, DOCF values larger than 1.0000 indicate higher than
expected machine output.
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.
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).
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.
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.
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.
Check that the DOC factor is correct for the machine and energy combination
shown and click “Yes.”
Updated DOC
factor for the
selected linear
accelerator
Figure 119 – the ‘History’ tab shows all DOC values set for this machine, up to and including the
current DOC factor
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).
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.
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.
For example: The measured signal (𝑠𝑖𝑔𝑛𝑎𝑙𝑐𝑜𝑟𝑟 ) is 1020. The docf is 1.02. The value
for 𝑠𝑖𝑔𝑛𝑎𝑙𝑑𝑜𝑐 is calculated as 1020/1.02 = 1000.
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 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.
The Excel treatment reports include the DOC factor value applied to each
individual segment.
Figure 123 - Field Overview in Treatment Report showing the DOC Factor applied during monitoring
for each field
Figure 124 - Field Details section in Treatment Report showing 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