Halcyon and Ethos Radiotherapy System

Customer Release Note

Version 3.1

P1050091-004-D MARCH 2022

Legal Information
Publication ID
P1050091-004-D

Publication Title
Halcyon and Ethos Radiotherapy System Customer Release Note

Abstract
This publication provides immediate release information for using Halcyon and Ethos radiotherapy system release version
3.1.
This publication is the English-language original.

Trademarks
Varian Medical Systems, Inc. or its affiliates own the names of our products and services referenced herein. These names
® ™
are either registered trademarks ( ) or trademarks ( ) in the United States and/or other countries. All other trademarks are
the property of their respective owners. Any rights not expressly granted herein are reserved.

Copyright
© 2021–2022 Varian Medical Systems, Inc. All rights reserved. Published in the United States of America.
No part of this publication may be reproduced, translated, or transmitted without the express written permission of Varian
Medical Systems, Inc.

Notice
Information in this publication is subject to change without notice and does not represent a commitment on the part of
Varian.

Electronic Labeling
This symbol on the label indicates that the Instructions for Use for the corresponding product are available at
www.MyVarian.com. Access the Instructions for Use in electronic form by logging in with your assigned MyVarian user
credentials.

In compliance with Anvisa and EU regulations, Varian will send Brazil and EU customers a free
printed copy of the Instructions for Use within 7 days. Use the “Paper Publication Request”
form provided on the Varian webpage to order your copy.

Legal Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304
United States of America

Contact Varian Customer Support / Report Incidents

For customer support, go to www.MyVarian.com and select Contact Us. Use MyVarian to report incidents. If you do not
have access to MyVarian, contact your local representative or call +41-41-749-8844.
Any serious incident that has occurred while using the device should be reported to the manufacturer and the competent
authority of the Member State in which the user or patient is established.

FDA 21 CFR 820 Quality System Regulations (cGMPs)

Varian Medical Systems, Oncology Systems products are designed and manufactured in accordance with the
requirements specified within this federal regulation.

CAUTION:  US Federal law restricts this device to sale by or on the order of a physician.

2 Halcyon and Ethos Radiotherapy System Customer Release Note

 WHO
ICD-O codes and terms used by permission of WHO, from:
● International Classification of Diseases for Oncology, Third Edition.
ICD-10 codes and terms used by permission of WHO, from:
● International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10).

EU REACH SVHC Disclosure

The link to the current EU REACH SVHC disclosure statement can be found at
http://www.varian.com/us/corporate/legal/reach.html

International Organization for Standardization ISO 13485

Varian Medical Systems, Oncology Systems products are designed and manufactured in accordance with the
requirements specified within the ISO 13485 quality standard.

Medical Device

Authorized Representative in the EU

Varian Medical Systems Nederland B.V.
Kokermolen 2
3994 DH Houten
The Netherlands

2797

Legal Information 3
Table of Contents
Introduction ................................................................................................................... 5
About Version 3.1 .............................................................................................................................. 5

System Components and Compatibility ..................................................................... 6

System Components and Compatibility ............................................................................................ 6

New Features and Enhancements .............................................................................. 8

Version 3.1 New Features and Enhancements ................................................................................. 8

Changes from the Previous Release ........................................................................ 10

March 2022 Revision D Customer Release Note Changes ............................................................ 10
September 2021 Revision C Customer Release Note Changes ..................................................... 10
Version 3.1 Changes ....................................................................................................................... 10

Known Issues .............................................................................................................. 12

Known Issues .................................................................................................................................. 12
Known Issues for Patients ...................................................................................................... 12
Known Issues for Treatment Providers .................................................................................. 12
Known Issues for Quality Providers ....................................................................................... 14
Known Issues for Configuration Administrators ..................................................................... 16

User Documentation and Support ............................................................................ 17

Related Publications ........................................................................................................................ 17
Contact Varian Customer Support ................................................................................................... 17

4 Halcyon and Ethos Radiotherapy System Customer Release Note

Introduction

About Version 3.1

This publication covers two models of radiotherapy systems:
™
● Halcyon
™
● Ethos radiotherapy system
The system is an advanced Image Guided Radiation Therapy (IGRT) treatment system designed
to deliver high-quality treatment plans to your patients.
The customer release note provides information on the current system performance and behavior
that is considered notable and supplemental. It is important for all operators of the system to
review all user documentation prior to using the system for clinical operation.

WARNING:  This customer release note is intended for radiation therapists,

radiation oncologists, dosimetrists, and medical physicists who are
qualified and properly trained users of the above mentioned hardware
and/or software. The users must be familiar with all functions, the
consequences of all operations, and the potential hazards involved.

For additional safety related information, refer to the instructions for use. See Related
Publications on page 17.

Introduction 5
System Components and Compatibility

System Components and Compatibility

This Customer Release Note describes the compatibility of software and hardware. If your
product or component is not listed, consider it to be not compatible.

Table 1  Halcyon Compatible Software Products

Varian Software Products Version

®
ARIA OIS for Radiation Oncology 15.1.0.20 and later
®
ARIA Radiation Therapy Management 15.1.0.20 and later
™
Eclipse 15.6 (Some features might not be supported.
For more information, see the Eclipse docu-
mentation.)
16.0 and later

Table 2  Ethos Radiotherapy System Compatible Software Products

Varian Software Products Version

Ethos treatment planning 1.0.10 and later
Ethos treatment management 2.0 and later

Table 3  Compatible Hardware Products

Varian Hardware Products Version

Varian IGRT Couch top Not applicable
IDENTIFY (Non-interfaced) Refer to the latest IDENTIFY Customer Re-
lease Note

6 Halcyon and Ethos Radiotherapy System Customer Release Note

 Table 4  Compatible Third-Party Products

Third-Party Software or Hardware Products Version

®
Orfit AIO Solution 3.0
● AIO Solution 3.0 Carbon Fibre Base Plate
for Halcyon and Ethos Radiotherapy
System (Orfit Article No. 38009)
● AIO Solution 3.0 Long Extension Frame for
Knee and Foot Support (Orfit Article No.
38210)
™
● AIO Solution 3.0 Loxon Set for Halcyon
and Ethos Radiotherapy System (Orfit Ar-
ticle No. 38212)
● High Precision Plate-to-Couch Fixation De-
vices 2-Pin Bar (Orfit Article No. 32166)
— For the latest information, visit
www.varian.com/why-varian/interoperability.

Table 5  Compatible Devices and Browsers for the Responsive User Assistance

Devices and Browsers Version

® ®
Apple iOS 10 and later
®
iPhone 6S Plus or later, including XR and
XSMax
® ®
iPad Pro and iPad Air with 9.7 inch or larger
screen
™
Android platform 6.0 (Marshmallow) and later
®
Firefox browser 58.0.2 (64-bit) and later
®
Microsoft Edge browser 40.15063.674.0
Microsoft EdgeHTML browser engine 15.15063
®
Internet Explorer browser 11.0.9600 and later
™
Google Chrome browser 64.0.3282.186 (Official Build) (64-bit) and later
On some systems, video captions are not dis-
played in the Google Chrome browser.

System Components and Compatibility 7

New Features and Enhancements

Version 3.1 New Features and Enhancements

Several enhancements were made and issues addressed with version 3.1 (03.01.0023). The
following product enhancements were suggested by customers like you.
For more information on the version 3.1 enhancements, refer to the instructions for use. See
Related Publications on page 17.

CBCT Mode Editor (reference 596620)

With the CBCT mode editor, the QA provider can now customize kV modes to better meet your
imaging protocols. For more details, refer to the instructions for use.

Persistent ROI Setting for Image Matching (reference 628867)

Now, when you change the region of interest for imaging matching, the system will retain your
settings.

Privacy on the Touchscreen (reference 530905)

Like on the treatment screen, it is now possible to hide the patient information on the touchscreen
inside the treatment room. For more details, refer to the instructions for use.

Missing Time Display (reference 649570)

With version 3.0, Varian removed the clock display from the user interface. We received lots of
feedback that being able to see that the time is important, so the clock display is back.

Logged In User Display (reference 570421)

You will now see the name of the person who is logged in instead of the username.

Live View Display in Service Mode (reference 440415)

Now, there is a dedicated live view display tab in service mode.

System Calibration Summary Report (reference 511869)

It is now possible to create a PDF of a system calibration summary report.

RDSR DICOM Tags (reference 543716)

The RDSR file now populates the DICOM Accession Number Attribute (0008, 0050).

Feature List in System Administration (reference 597283)

In System Administration, the names of the installed features have been changed to reflect the
marketing terms.

8 Halcyon and Ethos Radiotherapy System Customer Release Note

 Plan and Machine QA Warning Changed to an Icon (reference 715746)
An icon in place of text was introduced to reduce confusion when translated to different
languages.

New Features and Enhancements 9

Changes from the Previous Release

March 2022 Revision D Customer Release Note Changes

This revision of the Customer Release Note is not specific to a new version of software but
documents new issues that have been identified and issues that were addressed but not
documented.

System Components and Compatibility

● New compatibility with IDENTIFY. See Table 3 Compatible Hardware Products on page 6.

New Issues
● Load button does not illuminate on page 12
● Inconsistent availability of Imaging tools on page 12
● Cannot customize the CBCT Modes on page 14
● RDSR reporting is not disabled in Plan QA workflow on page 14
● Portal dosimetry missing dose on page 15
● Missing reference to the user right for high dose treatments on page 16

September 2021 Revision C Customer Release Note Changes

This revision of the Customer Release Note is not specific to a new version of software but
documents new issues that have been identified and issues that were addressed but not
documented.

System Components and Compatibility

● New third-party compatibility with Orfit AIO. See Table 4 Compatible Third-Party Products on
page 7.

New Issues
● Extended CBCT uses wrong center for acquisition (Halcyon only) on page 12
● Incorrect model name display in the About box (Ethos radiotherapy system only) on
page 15

Version 3.1 Changes

This section describes the notable changes made to the system for release version 3.1
(03.01.0023).

Previous Known Issues

The following known issues have been addressed.
● Load zone change (reference 688722, 626234)

10 Halcyon and Ethos Radiotherapy System Customer Release Note

 With version 3.0, you might have had to move your patient up further on the couch. This was
due to the software assuming that all kV CBCT images were programed with extended
imaging. Now, the Load button is available when the longitudinal couch position is
≤106.24 cm. However, if you are going to use extended imaging, make sure to position your
patient as close to the end of the couch as possible to make sure that you can achieve the
couch shift.
● Tab order change (reference 645022, 730485)
The tab order when signing off is now working as expected.
● System recovers to conflict with adaptive workflow, in Ethos radiotherapy treatment
(reference 603908, 625351)
The Ethos radiotherapy system will respond as expected if the logged-in user does not have
the correct user rights.
● Bolus requires second verification in Ethos radiotherapy treatment (reference 625352,
559852)
You no longer need to enter the treatment room again to verify the bolus for the adapted plan.
● Closing a patient takes a long time (reference 548196, 625340)
Plans with large number of treatment fields or control points close more efficiently.
● System restarts during automatic image matching (reference 586222, 586224)
If you click Stop during automatic image matching, the system will stop as expected.
● User cannot clear message that DICOM recovery data exists (reference 586225, 664896)
You now have the option to delete the DICOM recovery data after importing.
● Missing indication for patient motion monitoring calibration (reference 606051, 664899)
The system now has an indication when calibration is complete.
● Unable to complete Initialization (reference 723277)
You can now complete initialization after canceling.
● Setting up large patients (reference 581658, 709706)
You no longer need to raise the couch a small amount before setting up your larger patients.
● Unable to complete plan QA in Ethos radiotherapy treatment after a termination (reference
588201, 625356)
The system now allows you to complete QA without encountering a connecting to service
message.
● Couch continues to move after a collision (reference 697895)
The system stops after clearing a collision and pressing a motion button at the same time.

Changes from the Previous Release 11

Known Issues

Known Issues
This section describes the notable known issues with the system.
If the suggestions do not address your issue or your issue is not listed, then Contact Varian
Customer Support.
The known issues section, like the instructions for use, is organized by the role that you perform
or by who will be affected by the issue.

Known Issues for Patients

None at this time. As a reminder, always explain to your patient that different noises during
radiation treatments are possible and not to move.

Known Issues for Treatment Providers

Load button does not illuminate

Reference: 1098825
If the Load button is not lit after aligning your patient, most likely the plan includes a very large
longitudinal delta couch shift, and the couch cannot reach the patient's planned isocenter inside
the bore.
Suggestion:
To ensure that you will be able to load your patient for treatment, the planned longitudinal delta
couch shift should be between:
● 0.00 cm and −17.00 cm that moves the couch away from the bore.
or
● 0.00 cm and +30.00 cm that moves the couch further into bore.

Inconsistent availability of Imaging tools

Reference: 1094469
After performing an imaging match, the show/hide structure tool might not be available.
Suggestion:
● Click on a different axis display. The show/hide structure tool is available now.

Extended CBCT uses wrong center for acquisition (Halcyon only)

Reference: 942112
If you are delivering more than one plan and at least one plan has multiple isocenters defined for
extended imaging, the system uses an incorrect center of acquisition during imaging. When this
happens, you might not see all the anatomy as expected. However, the patient shift will be
calculated correctly.

12 Halcyon and Ethos Radiotherapy System Customer Release Note

 Suggestion:
● If you do not see the intended anatomy, disable extended CBCT and try again.
● Load one plan at a time.

Couch moves in an unexpected direction

Reference: 915790 and 904558
On very rare occasion, if the Treatment Provider inside of the room presses the Unload button at
the exact same time a Treatment Provider closes the patient record, the couch might move in an
unexpected direction. This is due to a software timing issue when sending the couch unload
targets.
Suggestion:
● Release the motion control button, and then press and hold the motion control button again.

Motion controls not responding

Reference: 907325
On rare occasion, you might need to press the motion control button more than once before the
couch begins to move. This is due to a software timing issue.
Suggestion:
● Press and hold the motion control button again.

kV CBCT stops during acquisition using large pelvis mode

Reference: 896309
If you are using large pelvis mode with the maximum mAs configured, the system stops during
image acquisition.
Suggestion:
● Press beam on to continue image acquisition
● Use a lower mAs to avoid having to press beam on more than once.

Plans with high MUs result in fault 210020

Reference: 881351
On occasion during delivery of plans with a high number of MUs, you might encounter fault
210020. This is due to small offsets between the MU1 and MU2 gain that can result in the 5% or
5 MU (whichever is higher), and an upper limit of 23 MU is being reached too quickly.
Suggestion:
● Ask your Quality Provider to calibrate dose more often if you are treating several high-dose
plans.

Dynamically flattened beams cannot be delivered

Reference: 881357

Known Issues 13
 On occasion during treatment delivery of beams with low MUs and lots of control points, you
might encounter fault 142001 and cannot complete the treatment. These faults are due to the
number of monitor units and the timing of the control system. While the system might permit
delivery of these beams for one fraction, the system might fault the next time this beam is
delivered. This issue is most likely to occur during delivery of dynamically flattened beams.
Suggestion:
● Ask your Quality Provider to create a new plan using ≥10 MU for dynamically flattened
beams.

Couch moves away from the target position

Reference: 743105
On occasion when you apply the patient shift, the couch will reach the treatment position.
However, when you release the motion controls, the couch will move slightly, and beam on is not
possible.
Suggestion:
● Press and hold the motion controls again.

Couch moves unexpectedly

Reference: 155103; 444102
On occasion, when assisting heavier patients onto or from the couch, the couch might move
laterally when pressure is applied.
Suggestion:
● Use caution when assisting your patients onto or from the couch.
● Use the lateral motion control button to move the couch away from the patient until it stops,
and then assist the patient onto the couch.
● If you see an interlock indicator on the touchscreen, the couch is outside of the clinical range,
but you can continue to use the motion controls to complete patient setup.

Known Issues for Quality Providers

Cannot customize the CBCT Modes

Reference: 1106090
If your system is configured for German language, it might not be possible to customize your
CBCT Modes due to the default modes having duplicate anatomical translations.
Suggestion:
● Contact Varian. The MICAP language on the Varian Service Portal needs to be set to English
to edit the CBCT modes, and then set back to German.

RDSR reporting is not disabled in Plan QA workflow

Reference: 1086845

14 Halcyon and Ethos Radiotherapy System Customer Release Note

 When performing plan QA, because the system uses the patient plan, the system will generate a
Radiation Dose Structured Report (RDSR) to report the dose from kV imaging. Besides the date,
it is not possible to distinguish that it was delivered to a phantom and not a patient.
Suggestions:
● When reporting accumulated imaging dose for a patient, do not include the imaging dose
from plan QA.
● Do not acquire a kV CBCT when performing QA on a patient plan.

Portal dosimetry missing dose

Reference: 1082839
On occasion when acquiring portal dosimetry images for quality assurance, there will be missing
frames. This can happen when delivering multiple beams and the last integrated image does not
finish sending before the next acquisition has started.
Suggestion:
● Do not enable automatic beam sequencing when acquiring portal dosimetry images. Deliver
one beam at time.

Incorrect model name display in the About box (Ethos radiotherapy system only)
Reference: 985844
On occasion during the installation process, the configuration file does not get updated to reflect
the model name for the Ethos radiotherapy system and will display “Halcyon” in the About box
instead.
Suggestion:
● Contact Varian Customer Support.

Unexpected error when launching plan QA mode

Reference: 882100
If you select a plan from the QUEUE for plan QA, you might encounter an error that will close the
treatment application.
Suggestion:
● Wait for the system to recover, move the couch to a longitudinal position > 0.00 cm, and then
load the plan again.

IEC standard for acoustic energy

Reference: 843217
Reference:
● Reference IEC 60601-1:2005 Clause 9.6.1
ME EQUIPMENT shall be designed so that human exposure to acoustic energy and vibration
shall not result in an unacceptable RISK.
Or

Known Issues 15
 ● Reference IEC 60601-1:2005 Clause 9.6.2.1
In NORMAL USE, the PATIENT, OPERATOR, and other persons shall not be exposed to
acoustic energy from ME EQUIPMENT, except sound from auditory alarm signals, exceeding
the levels specified as follows.
● 80 dBA for a cumulative exposure of 24 hours over a 24 hour period; an offset of 3 dBA is
to be added to this value when halving the cumulative exposure time over a 24 hour
period (for example, 83 dBA for 12 hours over a 24 hour period);
● 140 dB un-weighted sound pressure level for impulsive or impact acoustic energy (noise).
NOTE 1: Interpolation or extrapolation is allowed for exposure times in accordance with
the following formula, 80 – 10 * log10(h/24), in dBA, where h is cumulative exposure time
over a 24 hour period.
NOTE 2: Since PATIENTS might have a higher sensitivity to acoustic energy (noise), a
lower level could be more appropriate. Consideration should also be given to perception
of auditory alarm signals. The World Health Organization has recommended a maximum
impulse or impact acoustic energy (noise) level for children of 120 dB.
NOTE 3: If the A-weighted sound pressure level exceeds 80 dB(A), noise protection
measure should be considered.

Known Issues for Configuration Administrators

Missing reference to the user right for high dose treatments

Reference: 1040331
Your treatment providers might require the user right for High Dose Treatments when delivering
radiation treatments on this system.
Suggestion:
● Add this user right, if necessary.

Two files cannot be restored

Reference: 799757
If you need to restore all of your system configuration files, you will get a message that two files
did not restore. This is because these are system files and require Varian to restore them.
Suggestion:
● Contact Varian Customer Support

16 Halcyon and Ethos Radiotherapy System Customer Release Note

User Documentation and Support

Related Publications
The following user documentation is available on MyVarian:
● Halcyon and Ethos Radiotherapy System Instructions for Use (P10500891 and P10500902)
● Halcyon and Ethos Radiotherapy System Quick Reference Guide (P1028963)
● Halcyon and Ethos Radiotherapy System Machine Performance Check Reference Guide
(P1028964)
● Ethos End-to-End Workflow Description (P1037353)
● Halcyon and Ethos Radiotherapy System IEC Accompanying Documents Functional
Performance Characteristics (P1028966)
● Halcyon and Ethos Radiotherapy System IEC Accompanying Documents Site Tests and
Procedures (P1028967)
● Halcyon and Ethos Radiotherapy System IEC Accompanying Documents Type Tests and
Procedures (P1028968)

Contact Varian Customer Support

For user documentation, online training, or customer support, go to www.MyVarian.com.

1 PDF
2 Responsive User Assistance

User Documentation and Support 17