Xstrahl 150 User manual

Xstrahl 150 X-ray Therapy System Operator
Manual
Language: English

150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved
15/01/2020
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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]
FAX
[phone]
Technical Support
Web
www.xstrahl.com
Email
[email protected]om
Phone
[phone]
FAX
[phone]
Trademark
Xstrahl®is a registered trademark of Xstrahl Limited.
Notice of Copyright
Xstrahl 150 X-ray Therapy System Operator Manual ©2019
Disclaimer
Unless specifically agreed to in writing, Xstrahl assumes no liability
for use of this document if unauthorised changes to the content or
format are 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.
Compliance
The design of Xstrahl Systems is in compliance with internationally
recognised standards for safety.
All Xstrahl products have received CE marking approval for sale in
Europe, clearance by FDA for sale in the U.S.A., are licensed for
sale in Canada and are designed and manufactured in accordance
with an ISO13485:2016 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.
All systems are specified IP0X for environmental protection.

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File No., Revision, Year
150_OPMAN_GB Version 10 ©2019
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 the equipment.
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 modification 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

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Note:
Ensure the shipping box for the system and generator are stored
upright and the boxes are not stacked at any time.
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.
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

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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.
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.
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.

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Quality Assurance
The Xstrahl 150 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: 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.

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Intended Use (of
equipment)
Xstrahl® (100, 150, 200 and 300) X-Ray Therapy Systems are
intended to be used for radiation treatment of superficial skin
disorders, boney metastases and diseases of the skin, as determined
by a licensed medical practitioner where the system is being used.
They are intended to be used for single or fractionated treatment
(dose or time depending on system). Treatment should always be
determined by a licensed medical practitioner in the jurisdiction
where the system is being 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, 16/4/14).
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

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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 ............................................................................................................................... iii
Training ................................................................................................................................................. iv
Warnings and Cautions .......................................................................................................................iv
Specific Hazards ..................................................................................................................................iv
Safety ................................................................................................................................................... iv
Quality Assurance.................................................................................................................................v
Intended Function (of equipment) ....................................................................................................... v
Intended Use (of equipment)...............................................................................................................vi
Intended Function (of document) .......................................................................................................vi
Document Amendment Table .............................................................................................................vi
Table of Contents................................................................................................................................vii
List of Figures ......................................................................................................................................ix
Preface ................................................................................................................................................... x
Precautionary Information....................................................................................................... 1
1.1. Ionising Radiation .................................................................................................................... 1
1.2. Maintenance of Equipment ..................................................................................................... 1
1.3. Portable Personal Electronic Devices.................................................................................... 2
System Description.................................................................................................................. 3
2.1. Operator Interface .................................................................................................................... 4
Concerto ..................................................................................................................................... 4
Fisica........................................................................................................................................... 4
2.2. Filters and Applicators ............................................................................................................ 4
Filters......................................................................................................................................... 4
Applicators................................................................................................................................ 7
2.3. Xstrahl 150 Tube Stand............................................................................................................ 9
Xstrahl 150 Wall/Floor Stand Systems................................................................................. 10
Xstrahl 150 Ceiling System ...................................................................................................13
Manual Height Override (Power Off) .................................................................................... 15
2.4. Cleaning and Disinfecting ..................................................................................................... 15
Xstrahl 150 System Operations ............................................................................................17
3.1. Power On.................................................................................................................................17
3.2. System Warm-Up.................................................................................................................... 18
3.3. Interrupting an Exposure During the Beam Ramp Up........................................................19
3.4. Power Down Procedure .........................................................................................................19
Concerto®................................................................................................................................ 21
System Errors.........................................................................................................................23
5.1. System Error Table ................................................................................................................ 24

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List of Figures
Figure 2-1: Xstrahl 150............................................................................................................................ 3
Figure 2-2: Filter Carousel ...................................................................................................................... 4
Figure 2-3: Filter Holder Illustration......................................................................................................... 5
Figure 2-4: Applicator Illustration ............................................................................................................ 7
Figure 2-5: Inserting the Applicator Illustration ....................................................................................... 8
Figure 2-6: Floor/Wall Mounted Xstrahl 150 Illustration.......................................................................... 9
Figure 2-7: Movement Control Illustration............................................................................................. 10
Figure 2-8: Xstrahl 150 Brake/Movement Illustration............................................................................10
Figure 2-9: Ceiling Mounted System.....................................................................................................13
Figure 3-1: Example Warm-Up Window (Xstrahl 150)..........................................................................18

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Preface
This is the Operator Manual for the Xstrahl 150 X-Ray Therapy System. This
manual provides the information a medical operator requires to operate the
Xstrahl 150.
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 150.
Xstrahl 150 System Description
This section provides an overview of the Xstrahl 150 features, including the
interface, filters and applicators, and illustrations of the base unit and
tubestand.
Xstrahl 150 Operation
This section provides an overview of how to power on, warm-up and power
off the Xstrahl 150.
Concerto®
This section provides an overview of the Xstrahl 150 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.

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Section 1
Precautionary Information
_________________ In this section ___________________
1.1 Ionising Radiation ... ..................................................1
1.2 Maintenance of Equipment.........................................1
1.3 Portable Personal Electronic Devices.........................2
______________________________________________________
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/or patient.
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.

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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.

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Section 2
Xstrahl 150 System Description
_________________ In this section ___________________
2.1 Operator Interface.... ..................................................4
2.2 Filters and Applicators ...............................................4
2.3 Xstrahl 150 Tube Stand..............................................9
2.4 Cleaning and Disinfecting ..........................................15
______________________________________________________
System Description
The Xstrahl 150 is a superficial X-Ray therapy system producing X-Rays up
to 150kV. 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: Xstrahl 150

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2.1. Operator Interface
The Xstrahl operator interface consists of two elements:
• A PC running Concerto (clinical software) and Fisica (physics software);
• An operator control pod.
Concerto
Concerto enables the clinical operator to:
• create patients;
• define and deliver treatment fields in time or dose and
• maintain records of all exposures.
More information can be found in the Concerto section in this manual.
Fisica
Fisica is database-driven physics software used to calibrate the system.
Note:
More information on Fisica can be found in the Xstrahl Technical Manual
provided with the equipment.
2.2. Filters and Applicators
The Xstrahl 150 has interlocked filters.
Filters
The filter holder consists of a main body, filter holder ring and a handle.
Figure 2-2: Filter Carousel

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Each Xstrahl 150 system can have up to ten filters—nine clinical filters and
one warm-up filter. The system uses encoding to detect treatment filters
within the filter storage unit. The clinical filters can be constructed in
accordance with the half value layers defined by the medical department.
Each filter can be constructed from a maximum of three materials, up to a
maximum physical thickness of 2 mm. The materials and thickness, in
combination with the kV for the clinical filter give a resultant HVL as
measured by the physicist; the HVL achieved will affect the percentage
depth dose achieved.
Note:
Please refer to the British Journal of Radiology, Supplement 25 for details
on percentage depth doses for a range of HVL’s.
The warm-up filter has 2 mm of lead pre-installed in the holder. The materials
used in the filters are aluminium and copper. Only the filter required for the
treatment should be removed from the storage unit. Treatment delivery will
be prohibited if more than one filter is removed from the storage unit or the
wrong filter is inserted into the machine head because all filters are
interlocked within the storage box.
Each filter has a unique place in the filter storage unit as defined by the
mechanical shape of the storage unit and filter holders. Partial insertion of a
filter into any holder position is possible, but the electronic recognition will
not occur. The Xstrahl system will display the error message: two filters out
of box.
Figure 2-3: Filter Holder Illustration
CAUTION: The filter shoulder should only be manipulated by
the handle. Contact with the filter material should be avoided to
prevent damage to the filter material.

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The filter material is held in place in the filter holder by a ring, which is fixed
by screwing through the ring and the filter material into the filter holder body.
The front handle end of the filter bears the filter holder identification R for
the warm-up filter and 1 to 9 for all of the other filters.
The warm-up filter has 2 mm of lead pre-installed in its holder to prevent
unwanted X-Ray emissions during the warm-up. When either the warm-up
filter or any of the treatment filters are required for use, they need to be
removed from the filter storage unit.
2.2.1.1. Removing the Filter
To remove a filter from the filter ladder:
1. Gently pull on the filter, then, holding the filter by its integral handle,
insert the holder into the filter slot in the system sub-tube assembly.
2. Gently push the filter into the slot until a distinctive click sound can
be heard to indicate the filter holder is correctly located (by a
ball/indent locating mechanism).
When the filter is no longer required, it should be returned to the filter storage
unit. It is recommended that the warm-up filter be inserted into the sub-tube
assembly overnight, thus enabling the system to be ready for its daily warm-
up on the next working day.
2.2.1.2. Filter kV Settings
Xstrahl 150 filter settings:
Xstrahl 150 Filter kV Settingsᵃ
Filter
1
2
3
4
5
6
7
8
9
kV
30
40
50
80
100
120
120
140
150
HVL
(mm)
0.2 Al
0.5 Al
1.0 Al
2.0 Al
3.0 Al
4.0 Al
5.0 Al
8.0 Al
0.5 Cu
Added
filtration
(mm)
0.25 Al
0.55 Al
1.2 Al
2.0 Al
2.5 Al
1.1 Al
0.05
Cu
0.8 Al
0.1 Cu
1.4 Al
0.2 Cu
0.5 Al
0.25 Cu
a. The kV, mA and HVL values must be checked and recorded in the
Acceptance Test Document.

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Applicators
CAUTION: Care should be exercised at all times when handling
the applicators so as not to damage the applicator.
Figure 2-4: Applicator Illustration
Standard range of applicators for the Xstrahl 150:
Xstrahl 150 Applicators
15 cm FSD Open Applicators
25 cm FSD Open Applicators
1.5 cm diameter
10 cm diameter
2 cm diameter
15 cm diameter
2.5 cm diameter
3 cm diameter
4 cm diameter
5 cm diameter
Note:
Applicators are not interlocked in the sub-tube assembly. The operator
must ensure the correct applicator is fitted to the machine before enabling
X-Rays On..
System applicators are normally stored in the treatment room. They should
be stored with the stainless steel top, face down on a protective fabric surface.
Usually, the 15 cm and 25 cm FSD applicators are open-ended with clear
viewing ends.
CAUTION: Care should be exercised at all times when handling
applicators. The weight of each applicator varies (0.45 to 1.1 kg) with
the heaviest being the largest field size at 25 cm FSD. The identification
of each applicator in terms of the field size and FSD is engraved on the
underside of the top element of each applicator.

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2.2.2.1. Inserting the Applicator
Note:
Two hands should always be used to hold the applicator when carrying the
applicator for insertion into the sub-tube assembly. The applicator should
only be inserted with the sub-tube assembly in the 0º position.
Figure 2-5: Inserting the Applicator Illustration
Inserting the Applicator:
1. Align the applicator with the sub-tube assembly opening.
2. Push the applicator up into the assembly and twist anti-clockwise
until the spring locking system engages and a click is heard as it is
locked in place. It is not possible to rotate the applicator within the
sub-tube assembly. Figure 2–7: Applicator Movement
2.2.2.2. Removing the Applicator
Removing the applicator:
1. Twist the applicator clockwise within the sub-tube assembly until the
locking system disengages. Care should be taken when removing the
applicator because the sub-tube assembly does not support the
applicators weight.
2. Use two hands to remove the applicator from the sub-tube assembly
and return the applicator to the storage facility.
2.2.2.3. Cleaning the Applicators
WARNING: Contact with alcohol can damage the applicators.
Xstrahl recommends that only products which are free from
alcohol are used to clean the applicators.
Due to the ends of the treatment applicators being constructed of Lucite®
(Perspex®), it is not recommended that products containing a high level of
alcohol be used to clean the applicators after use. It is possible that alcohol
could cause significant damage to the Lucite®.