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.

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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

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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

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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

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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) ...................................................................................................... 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

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System Errors..........................................................................................................................5-2
5.1. System Error Table .................................................................................................................5-3