Xstrahl RADiant User manual

RADiant Therapy System
Operator Manual
Language: English

About Xstrahl RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | i
About Us
Xstrahl Limited produces specialist clinical solutions for medical
practitioners and their cancer and dermatology patients by offering a
range of superficial and orthovoltage X-Ray Therapy Systems, as
well as a comprehensive superficial therapy educational (STEP)
program for training and support.
Contact Information
Web
www.xstrahl.com
Email
[email protected]om
Phone
[phone]
Technical Support
Web
www.xstrahl.com
Email
[email protected]om
Phone
[phone]
Trademark
Xstrahl®is a registered trademark of Xstrahl Limited.
Notice of Copyright
RADiant Operator Manual ©2018 Xstrahl Limited. All Rights
Reserved.
Disclaimer
Unless specifically agreed to in writing, Xstrahl assumes no liability
for use of this document if unauthorised changes to the content or
formatare made. Every care has been taken to ensure the information
in this document is accurate. However, Xstrahl assumes no
responsibility or liability for errors, inaccuracies or omissions which
may occur in this document.
To improve reliability, function or design, Xstrahl reserves the right
to change the product and/or this manual without notice.
Compliance
The design of Xstrahl Systems is in compliance with internationally
recognised standards for safety. Xstrahl’s range of X-Ray therapy
systems are classified as Class IIb Medical Devices in accordance
with the Medical Devices Directive.
RADiant has clearance by FDA for sale in the U.S.A and is
manufactured in accordance with ISO13485:2003 certified quality
management system.
Classification of
Equipment (ME)
Xstrahl’s X-Ray Therapy Systems are classified as Class I Medical
Electrical (ME) equipment and are classified for continuous
operation with intermittent loading. With continuous operation of the
system in standby. After 20min continuous treatment exposure allow
4min cooling time (80% Duty Cycle).

RADiant Operator Manual About Xstrahl
ii | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
File No., Revision, Year
PHET_OP_GB, Version 7 ©2018
This document and all accompanying documents have been drafted
in the English language.
Acknowledgments
All manufacturer tradenames and trademarks appearing in this
document are hereby acknowledged.
Referenced
Documents
Not all documents referred to in this document are part of the scope
of delivery for the equipment. Xstrahl reserves the right to determine
the documents delivered with the product.
Compatibility/Contra
indications
Xstrahl X-Ray Therapy Systems must be used only in combination
with components expressly recognised by Xstrahl as compatible with
Xstrahl X-Ray Therapy Systems. Before using any equipment or
component not supplied by Xstrahl, consult Xstrahl for advice on
compatibility.
The use of components other than those specified by Xstrahl may
affect electromagnetic compatibility (EMC) performance and result in
increased emissions or decreased immunity of theequipment.
Modification of
Equipment
Changes and/or additions to Xstrahl X-Ray Therapy Systems must
be performed only by persons expressly authorised by Xstrahl. Such
changes must comply with best engineering practice and all
applicable laws and regulations within the jurisdiction.
Any modifications during the service life of the equipment requires
evaluation to the requirements of EN60601-1 and EN60601-2-8
Environmental
Conditions
Xstrahl systems are designed to be operated and stored within the
following environmental conditions:
Ambient Humidity
Storage Temperature
Operating Temperature
Note:
Ensure the shipping box for the system and generator are stored
upright and the boxes are not stacked at any time.

About Xstrahl RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | iii
Electromagnetic
Compatibility
The Xstrahl Radiotherapy systems are suitable for use in a clinical or
hospital environment, within a suitable lead shielded treatment room
(for relevant X-Ray radiation protection).
Xstrahl has declared the following essential performance when
subject to electromagnetic emissions or RFI immunity:
Treatment Mode
X-Ray beam can carry on running and complete the correct
treatment
X-Ray beam can be interrupted or stopped
X-Ray beam can be interrupted, and error messages are
visible
Electronic component failure prevents the X-Ray beam from
running
Standby Mode
X-Ray beam cannot be run
Errors can be reported
Power on fail LCD will still read with power off
WARNING: Use of Xstrahl equipment adjacent to or stacked
with other equipment should be avoided to prevent improper
operation.
WARNING: Equipment spare parts, cabling and accessories
should only be replaced with Xstrahl specified parts to prevent
increased EMC emissions or decreased immunity of the
Xstrahl system.
WARNING: Portable RF communication equipment
(example; antenna cables or antennas) should be used no
closer than 30cm to any part of the Xstrahl system
Portable Personal
Electronic Devices
Portable personal electronic devices (intravenous pumps, cardiac
pacemakers, intravenous devices and other implanted devices)
should not be placed in front of a radiation beam. Small doses of
radiation could cause the devices to malfunction. Failure to observe
this warning could cause these devices to malfunction which could
result in serious injury or even death. Always monitor the operation
of portable personal electronic devices during radiation treatment.

RADiant Operator Manual About Xstrahl
iv | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
Intended Audience
The information contained in this manual is intended solely for the
use of trained and competent medical operators preferably trained by
Xstrahl or an authorised person. Training requirements vary by
country. Operators must ensure that training is provided in
accordance with all applicable local laws and regulations.
Training
All operators must have the required training before attempting to
operate the Xstrahl X-Ray Therapy System. Because countries have
different regulations for training, the operator must be compliant
with the local laws and regulations of the jurisdiction in which the
equipment is installed..
Warnings and Cautions
All potential hazards to the health of personnel and to the integrity of
Xstrahl’s equipment are presented as Warning and Caution notices.
All Warning and Caution notices in this manual will appear at the
point of application.
Sample Warnings and Cautions:
WARNING: Warnings alert operators to potential hazards to
personal health and safety. Each warning explains the nature
of the hazard, states the means by which the risk can be
avoided and explains the consequences of failing to observe
the warning.
CAUTION: Cautions alert operators to the potential risk of
damage to the equipment or the environment, but not of
hazards to health and safety. Each caution explains the nature
of the hazard, the means by which the risk can be avoided and
explains the consequences of failing to observe the caution.

About Xstrahl RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | v
Specific Hazards
Xstrahl X-Ray Therapy Systems have system specific hazards that
are a potential risk to both personnel and equipment. All Specific
Hazard notices in this manual will appear at the point of application.
Sample specific hazards:
RADIATION: Xstrahl X-Ray Therapy Systems generate
ionising radiation which can cause death or injury if
precautions are not adhered to
WARNING: Warnings alert operators to potential hazards to
personal health and safety. Each warning explains the nature
of the hazard, states the means by which the risk can be
avoided and explains the consequences of failing to observe
the warning.
PROTECTIVE EARTH: Protective earth labels are placed
next to protective earth terminal studs. Ensure earth terminals
are connected to system earth at installation and before
operating the equipment. If any protective earth point is
disconnected, the equipment must not be used.
WARNING: To avoid risk of electric shock, this equipment
must only be connected to a supply mains with a protective
earth.
APPLIED PART: Type BF Applied Part
INSTRUCTIONS FOR USE: Consult Operator Manual for
Instructions for Use.
Safety
All operators of this equipment must read, obey and understand all
safety warnings, cautions, notes and safety labels on equipment.
All operators must read and understand all information in this
document.

RADiant Operator Manual About Xstrahl
vi | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
Quality Assurance
The RADiant defines the exposure in time and does not measure the
output of the X-Ray tube for each exposure conducted. The output
of each clinical energy needs to be measured during the acceptance
of the unit and schedule in the daily quality assurance conducted on
the machine.
The IPEM report 81, kilo voltage X-Ray units recommends that the
following quality control checks are conducted on superficial
systems
Table 1-1: Recommended Quality Control Checksa
Recommended Quality Control Checksb
Test Frequency
Tolerance
Daily
Output constancy check
± 5% If the daily output
constancy check
varies by more than
±5% from the previous
monthly output
calibration, an
investigation should be
performed. This should
include at least a
measurement of HVL.
Interlocks and warnings
Mechanical fixtures
Filter interlock
Weekly
(or following
repair)
Filter interlock
Monthly (or
following
repair
Output measurement
± 3%
Timer accuracy
± 0.01 min.
Filter interlocks
HVL constancy
± 10%
Annually (or
following
repair
Field uniformity
± 2%
Half value layer
Focal spot alignment
± 10%
a .Where no quantitative action level is indicated, the assessment is
subjective or based
on a yes/no decision.
b. Refer to IPEM (Institute of Physics and Engineering Medicine) report 81
for further details on recommended quality assurance checks
Intended Function (of
equipment)
Xstrahl’s range of superficial and orthovoltage X-Ray Therapy
Systems are intended to assist in the delivery of radiation to a
defined target area whilst sparing surrounding normal tissue

About Xstrahl RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | vii
Intended Use (of
equipment)
The Xstrahl RADiant Therapy System is a low energy X-ray system
intended for superficial radiotherapy and surface electronic
brachytherapy treatment of primary malignant epithelial neoplasms
of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma,
Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous
Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma,
Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous
Lymphomas (B and T cell) and Keloids.
Treatment determined by a licensed medical practitioner. Intended to
be used for single or fractionated treatment. Treatment should always
be determined by a licensed medical practitioner in the jurisdiction
where the system is used
Note:
In the United States, Federal law restricts the sale of these
devices, distribution and use by, or on or order of, a licensed
physician.
Intended Function (of
document)
The intended function of this document is to assist the operator in the
safe and correct operation, application and preventative maintenance
of the equipment. The operator is the authority who has the control
of the equipment and the person(s) who operates and works on the
equipment.
Xstrahl recommends that this document is kept with the equipment at
all times.
Document Amendment
Table
Xstrahl, at their discretion, may update sections of this document
after first issue. Updated document amendments will be marked by
an identifying release date which can be found at the bottom of all
document pages (for example, 22/5/14).
It is the responsibility of the operator to update the following
Document Amendment Table as new document amendments are
issued:
Document
No.
Section
Release Date
Authorised By

RADiant Operator Manual About Xstrahl
viii | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved

RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | ix
Table of Contents
About Us ................................................................................................................................................. i
Trademark............................................................................................................................................... i
Notice of Copyright................................................................................................................................ i
Disclaimer ............................................................................................................................................... i
Compliance............................................................................................................................................. i
Classification of Equipment (ME)......................................................................................................... i
File No., Revision, Year .........................................................................................................................ii
Acknowledgments .................................................................................................................................ii
Referenced Documents.........................................................................................................................ii
Compatibility/Contra indications .........................................................................................................ii
Modification of Equipment....................................................................................................................ii
Environmental Conditions ....................................................................................................................ii
Electromagnetic Compatibility ............................................................................................................iii
Portable Personal Electronic Devices ................................................................................................iii
Intended Audience................................................................................................................................iv
Training ..................................................................................................................................................iv
Warnings and Cautions........................................................................................................................iv
Specific Hazards ................................................................................................................................... v
Safety ................................................................................................................................................... v
Quality Assurance ................................................................................................................................vi
Intended Function (of equipment).......................................................................................................vi
Intended Use (of equipment) ..............................................................................................................vii
Intended Function (of document).......................................................................................................vii
Document Amendment Table .............................................................................................................vii
Table of Contents ....................................................................................................................................ix
List of Figure and Tables ........................................................................................................................xi
Preface ...................................................................................................................................................iii
1 Precautionary Information .......................................................................................................1-1
1.1 Ionising Radiation.................................................................................................................... 1-1
1.2 Maintenance of Equipment ..................................................................................................... 1-1
1.3 Portable Personal Electronic Devices ..................................................................................... 1-2
2 Xstrahl RADiant System Description ......................................................................................2-1
2.1 Operator Interface ...................................................................................................................2-3
2.1.1 Concerto..................................................................................................................................2-3
2.1.2 Fisica .......................................................................................................................................2-3
2.2 Filters.......................................................................................................................................2-3
2.2.1 Filter Settings .......................................................................................................................... 2-4
2.2.2 Installing the filter ....................................................................................................................2-4
2.2.3 Removing the filter ..................................................................................................................2-4
2.3 Applicators............................................................................................................................... 2-5
2.3.1 Inserting the Applicator............................................................................................................ 2-5
2.3.2 Removing the Applicator .........................................................................................................2-6
2.3.3 Cleaning the Applicators.......................................................................................................... 2-7
2.4 RADiant Therapy Base Unit Tube Stand.................................................................................2-7
2.4.1 Movement Controls ................................................................................................................. 2-8
2.4.2 The Support Arm .....................................................................................................................2-8
2.5 Warning Lights and Door Interlock........................................................................................2-10
2.6 Cleaning and Disinfecting .....................................................................................................2-10
2.6.1 Cleaning the Applicators .......................................................................................................2-11
2.7 Service Life and Disposal......................................................................................................2-11
3 Xstrahl RADiant Therapy System Operation ..........................................................................3-1
3.1 Power On ................................................................................................................................3-1
3.2 System Warm-Up .................................................................................................................... 3-2
3.3 Interrupting an Exposure During the Beam Ramp Up ............................................................3-3

RADiant Operator Manual About Xstrahl
x | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
3.4 Power Down Procedure ..........................................................................................................3-3
4 Concerto®............................................................................................................................... 4-1
4.1 Overview ................................................................................................................................. 4-1
5 5 System Errors....................................................................................................................... 5-1
5.1 System Error Table.................................................................................................................. 5-2

RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | xi
List of Figure and Tables
Figure 2-1: System Schematic.......................................................................................................... 2-1
Figure 2-2: RADiant Therapy System ............................................................................................... 2-2
Figure 2-3: RADiant Therapy System filter ....................................................................................... 2-3
Figure 2-4: RADiant Therapy filter being fitted ................................................................................. 2-4
Figure 2-5: RADiant Therapy Applicator........................................................................................... 2-5
Figure 2-6: RADiant Therapy system applicator being fitted ............................................................ 2-6
Figure 2-7: RADiant Therapy system applicator fitted ...................................................................... 2-6
Figure 2-8: RADiant Therapy System Base Unit .............................................................................. 2-7
Figure 2-9: Brake Button................................................................................................................... 2-8
Figure 2-10: Support Arm Range of Movement................................................................................ 2-9
Figure 2-11: Warning Lights (at access to treatment room) ........................................................... 2-10
Figure 3-1: Warm-Up Window .......................................................................................................... 3-2
Table 1-1: Recommended Quality Control Checksa............................................................................ vi
Table 2-1: System Schematic Descriptions ...................................................................................... 2-2
Table 2-2: Xstrahl RADiant Therapy standard filter settings ............................................................ 2-4
Table 2-3: Xstrahl RADiant Therapy range of applicators ................................................................ 2-5
Table 2-4: Support Arm Range of Movement ................................................................................... 2-9
Table 3-1: Warm up times................................................................................................................. 3-2

RADiant Operator Manual
ii | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved

RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | iii
Preface
This is the Operator Manual for the Xstrahl RADiant System. This manual
provides the information a medical operator requires to operate the Xstrahl
RADiant.
Precautionary Information
This section provides an overview of important safety information and
cautionary warnings which should be read and thoroughly understood
prior to operating the Xstrahl RADiant.
RADiant System Description
This section provides an overview of the Xstrahl RADiant features,
including the interface, filters and applicators, and illustrations of the base
unit and tube stand.
RADiant Operation
This section provides an overview of how to power on, warm-up and
power off the Xstrahl RADiant.
Concerto®
This section provides an overview of the Xstrahl RADiant main menu
options, including file, treatment, system errors, system interlocks, reports
and treatment database and errors.
System Errors
This section provides a description of the system messages and errors.
About Xstrahl
Refer to the About Xstrahl section at the front of this manual for more
information about Xstrahl.

RADiant Operator Manual
iv | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved

RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | 1-1
Section 1:
Precautionary Information
_________________ In this section___________________
1.1 ...........Ionising Radiation ...........................................1-1
1.2 ...........Maintenance of Equipment .............................1-1
1.3 ...........Portable Personal Electronic Devices..............1-2
______________________________________________________
1 Precautionary Information
RADIATION: X-Ray equipment emits ionising radiation and is
dangerous to both operator and personnel within close proximity.
To avoid risk of injury, observe all safety measures and ensure
you are adequately trained prior to operating this equipment.
1.1 Ionising Radiation
The instructions within this operator’s manual should be thoroughly read
and understood before operating the Xstrahl X-Ray Therapy System.
This equipment incorporates various safety features and components.
Before using this equipment, operators must carefully read and thoroughly
understand the instructions in this manual. The operator should pay special
attention to all safety warnings. Failure to observe these instructions could
result in serious injury to the operator and/or patient.
1.2 Maintenance of Equipment
As with all electro-mechanical equipment, the various components of the
Xstrahl Systems require periodic maintenance to ensure both operational
safety and optimum performance. Failure to observe periodic maintenance
can present a serious safety risk which could result in serious injury to the
operator and/orpatient.
Please observe the Preventive Maintenance Procedures included in the
Xstrahl Technical Manual provided with the equipment. Recommended
maintenance intervals and schedules are also described in the Xstrahl
Technical Manual.

RADiant Operator Manual Section 1: Precautionary Information
1-2 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
1.3 Portable Personal Electronic Devices
WARNING: Portable personal electronic devices (intravenous
pumps cardiac pacemakers, intravenous devices and other
implanted devices) should not be placed in front of a radiation
beam. Small doses of radiation could cause these devices to
malfunction. Failure to observe this warning could cause these
devices to malfunction, which could result in serious injury or
death.
Always monitor the operation of portable personal electronic devices
during radiation treatment.

RADiant Operator Manual
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | 2-1
Section 2:
RADiant System Description
_________________ In this section___________________
1.1 ...........Ionising Radiation ...........................................1-1
1.2 ...........Maintenance of Equipment .............................1-1
1.3 ...........Portable Personal Electronic Devices..............1-2
______________________________________________________
2 Xstrahl RADiant System Description
The RADiant Therapy system is a superficial X-Ray therapy system
producing X-Rays up to 80kV. The energy of the beam is defined as the half
value layer, which is dependent on the kV selected and the filter materials
placed within the X-Ray beam.
Figure 2-1: System Schematic

RADiant Operator Manual Section 2: Xstrahl RADiant System Description
2-2 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved
Table 2-1: System Schematic Descriptions
Description
Location
1
Mains isolator and Circuit breaker or Maint
socket
Treatment Room
2
Controller
3
X-Ray System (Base Unit)
4
Warning Lights
By Access Door to Treatment Room
5
Door Interlock
6
Control POD
Control Room
7
PC Computer
Figure 2-2: RADiant Therapy System