Xstrahl 100 User manual

Xstrahl 100 X-Ray Therapy System
Operator Manual
Language: English

About Xstrahl Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 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]
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 100 Operator Manual ©2017 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
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 ISO13485:2003 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.
All systems are specified IP0X for environmental protection.

Xstrahl 100 Operator Manual About Xstrahl
ii | 06/04/2018 100_OPMAN_GB Version 9© Xstrahl Ltd. All Rights Reserved
File No., Revision, Year
100_OPMAN_GB, Version 9 ©2014
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
Note:
Ensure the shipping box for the system and generator are stored
upright and the boxes are not stacked at any time.

About Xstrahl Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 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.
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

Xstrahl 100 Operator Manual About Xstrahl
iv | 06/04/2018 100_OPMAN_GB Version 9© Xstrahl Ltd. All Rights Reserved
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.

About Xstrahl Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | v
Quality Assurance
The Xstrahl 100 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

Xstrahl 100 Operator Manual About Xstrahl
vi | 06/04/2018 100_OPMAN_GB Version 9© Xstrahl Ltd. All Rights Reserved
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.
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, 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

Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | vii
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) ...................................................................................................... vi
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
1.1. Ionising Radiation....................................................................................................................1-1
1.2. Maintenance of Equipment......................................................................................................1-1
1.3. Portable Personal Electronic Devices .....................................................................................1-2
Xstrahl 100 System Description ..............................................................................................2-1
2.1. Operator Interface ...................................................................................................................2-2
Concerto ..................................................................................................................................2-2
Fisica .......................................................................................................................................2-2
2.2. Filters.......................................................................................................................................2-3
Filter kV Settings .....................................................................................................................2-4
2.3. Applicators...............................................................................................................................2-4
Inserting the Applicator............................................................................................................2-5
Removing the Applicator .........................................................................................................2-6
Cleaning the Applicators .........................................................................................................2-6
2.4. Xstrahl 100 Base Unit Tube Stand ..........................................................................................2-7
Movement Controls .................................................................................................................2-7
The Support Arm .....................................................................................................................2-8
Range of Movements ..............................................................................................................2-8
2.5. Cleaning and Disinfecting........................................................................................................2-9
Xstrahl 100 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
3.4. Power Down Procedure ..........................................................................................................3-4
Concerto®................................................................................................................................4-1

Xstrahl 100 Operator Manual
viii | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved
System Errors..........................................................................................................................5-2
5.1. System Error Table .................................................................................................................5-3

Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | ix
List of Figures
Figure 2-1: Xstrahl 100.........................................................................................................................2-1
Figure 2-2: Filter Carousel ...................................................................................................................2-3
Figure 2-3: Xstrahl 100 Filters..............................................................................................................2-3
Figure 2-4: Fiting the Applicator ...........................................................................................................2-5
Figure 2-5: cont'd.. ...............................................................................................................................2-5
Figure 2-6: cont'd.. ...............................................................................................................................2-5
Figure 2-7: cont'd .................................................................................................................................2-5
Figure 2-8: Xstrahl 100 Base Unit ........................................................................................................2-7
Figure 2-9: Rotational Movement Illustration .......................................................................................2-7
Figure 2-10: Clamp Brake Illustration ..................................................................................................2-8
Figure 3-1Warm-Up Window (Using 200 Warm-Up Times Only) ........................................................3-2

Xstrahl 100 Operator Manual
x | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved
Preface
This is the Operator Manual for the Xstrahl 100 X-Ray Therapy System.
This manual provides the information a medical operator requires to operate
the Xstrahl 100.
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 100.
Xstrahl 100 System Description
This section provides an overview of the Xstrahl 100 features, including the
interface, filters and applicators, and illustrations of the base unit and
tubestand.
Xstrahl 100 Operation
This section provides an overview of how to power on, warm-up and power
off the Xstrahl 100.
Concerto®
This section provides an overview of the Xstrahl 100 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.

Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved 06/04/2018 | 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
______________________________________________________
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.

Xstrahl 100 Operator Manual Section 1: Precautionary Information
1-2 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 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.

Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved 06/04/2018 | 2-1
Section 2
Xstrahl 100 System Description
_________________ In this section ___________________
2.1 Operator Interface.... ..................................................2-2
2.2 Filters....................... ..................................................2-3
2.3 Applicators .............. ..................................................2-4
2.4 Xstrahl 100 Base Unit Tube Stand .............................2-7
2.5 Cleaning and Disinfecting ..........................................2-9
______________________________________________________
Xstrahl 100 System Description
The Xstrahl 100 is a superficial X-Ray therapy system producing X-Rays up
to100kV. 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 100

Xstrahl 100 Operator Manual Section 2: Xstrahl 100 System Description
2-2 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved
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.

Section 2:Xstrahl 100 System Description Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 2-3
2.2. Filters
The Xstrahl 100 comes with an interlocked filter carousel pre-installed by
Xstrahl.
Figure 2-2: Filter Carousel
Figure 2-3: Xstrahl 100 Filters
Each Xstrahl 100 system can have up to six standard filters—five clinical
filters and one warm-up filter. The system uses encoding to detect treatment
filters within the machine head. The clinical filters can be constructed in
accordance with the half value layers defined by the customer.
The Xstrahl 100 filter can be made of aluminium or copper and be 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.
To install a filter:
Rotate the filter wheel, either anti-clockwise or clockwise until the required
filter clicks into the home position. Each filter location is numbered.

Xstrahl 100 Operator Manual Section 2: Xstrahl 100 System Description
2-4 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved
Filter kV Settings
Xstrahl 100 standard filter settings:
Xstrahl 100 Filter kV Settingsᵃ
Filter
1
2
3
4
5
kV
30
50
80
95
100
HVL1 (mm)
0.4 Al
1.00 Al
2.0 Al
3.0 Al
4.0 Al
Added filtration
(mm)
0.25 Al
0.80 Al
1.70 Al
2.0 Al
1.90 Al
0.05 Cu
a. The kV, mA and HVL values must be checked and recorded in the acceptance test
document.
2.3. Applicators
CAUTION: Care should be exercised at all times when handling
applicators. Two hands should be used when carrying the
applicator for insertion. The applicators weigh approximately 1
kg. 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.
Xstrahl 100 standard range of applicators:
Xstrahl 100 Applicators
15 cm FSD Open Applicators
25 cm FSD Open Applicators
2 cm diameter
10 cm diameter
4 cm diameter
15 cm diameter
6 cm diameter
8 cm diameter
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. Normally, the 15 cm and 25 cm FSD applicators are open-ended
with clear viewing ends.
The identification of each applicator, in terms of the field size and FSD, is
engraved on the forward facing base shoe.

Section 2:Xstrahl 100 System Description Xstrahl 100 Operator Manual
100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 2-5
Inserting the Applicator
To insert the applicator
1. Lift latch from the locked position.
Figure 2-4: Fiting the Applicator
2. Insert the applicator into the sub-tube assembly (the applicator will
only fit in one direction).
Figure 2-5: cont'd..
3. Push the applicator fully into the sub-tube assembly. When the
applicator reaches the home position, the latch will spring back
down into its locked position. It is not possible to rotate the
applicator within the sub-tube assembly.
Figure 2-6: cont'd..
4. Ensure the locking latch is in the home position before exiting the
treatment room.
Figure 2-7: cont'd

Xstrahl 100 Operator Manual Section 2: Xstrahl 100 System Description
2-6 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved
Removing the Applicator
To remove the applicator:
1. Lift latch and the applicator will be ejected slightly forward.
2. Pull the applicator (gently) out from the sub-tube assembly.
Two hands should be used to remove the applicator from the sub-tube
assembly before returning the applicator to the storage facility
Cleaning the Applicators
CAUTION: 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®.
The applicator manufacturer recommends a product free from alcohol be
used to clean the applicators, such as Sterets Unisept®, a sterile aqueous
solution containing Chlorhexidine Gluconate 0.05% w/v.
If you have any queries regarding the suitability of various cleaning
products, please contact Xstrahl Limited before using on the applicators.