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Xstrahl 100 Operator's Manual

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

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Summary of Contents for Xstrahl 100

  • Page 1 Xstrahl 100 X-Ray Therapy System Operator Manual Language: English...

  • Page 3: About Us

    The design of Xstrahl Systems is in compliance with internationally Compliance 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.

  • Page 4: File No., Revision, Year

    Not all documents referred to in this document are part of the scope Referenced of delivery for the equipment. Xstrahl reserves the right to determine Documents the documents delivered with the product. Xstrahl X-Ray Therapy Systems must be used only in combination...

  • Page 5: Electromagnetic Compatibility

    About Xstrahl Xstrahl 100 Operator Manual The Xstrahl Radiotherapy systems are suitable for use in a clinical or Electromagnetic hospital environment, within a suitable lead shielded treatment room Compatibility (for relevant X-Ray radiation protection). Xstrahl has declared the following essential performance when...

  • Page 6: Training

    All operators must have the required training before attempting to Training 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.

  • Page 7: Quality Assurance

    Xstrahl 100 Operator Manual 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.

  • Page 8: Intended Function (Of Equipment)

    Systems are intended to assist in the delivery of radiation to a defined target area whilst sparing surrounding normal tissue. Intended Use (of Xstrahl® (100, 150, 200 and 300) X-Ray Therapy Systems are equipment) 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.

  • Page 9: Table Of Contents

    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.
  • Page 10 Xstrahl 100 Operator Manual System Errors .......................... 5-2 5.1. System Error Table ......................... 5-3 viii | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...

  • Page 11: List Of Figures

    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) ............3-2 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd.

  • Page 12: Preface

    Xstrahl 100 Operator Manual 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.

  • Page 13: Precautionary Information

    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. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...

  • Page 14: Portable Personal Electronic Devices

    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. 1-2 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...

  • Page 15: Xstrahl 100 System Description

    ______________________________________________________ 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.

  • Page 16: Operator Interface

    More information can be found in the Concerto section in this manual. Fisica Fisica is database-driven physics software used to calibrate the system. More information on Fisica can be found in the Xstrahl Technical Manual Note: provided with the equipment.

  • Page 17: Filters

    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;...

  • Page 18: Filter Kv Settings

    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. 2-4 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...

  • Page 19: Inserting The Applicator

    It is not possible to rotate the applicator within the sub-tube assembly. Figure 2-6: cont'd.. Ensure the locking latch is in the home position before exiting the treatment room. Figure 2-7: cont'd 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 2-5...

  • Page 20: Removing The Applicator

    ® 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. 2-6 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...

  • Page 21: Xstrahl 100 Base Unit Tube Stand

    Xstrahl 100 Operator Manual 2.4. Xstrahl 100 Base Unit Tube Stand The Xstrahl 100 tube support is mounted on a TP2 base unit. The unit provides power distribution and control to all of the Xstrahl 100 system peripherals. Figure 2-8: Xstrahl 100 Base Unit...

  • Page 22: The Support Arm

    The full range of movements is detailed in the Xstrahl 100 Technical Description. The Xstrahl 100 base unit is not designed to be relocated between patients. The design enables the unit to be moved to a suitable location within the treatment room for a clinical session.

  • Page 23: Cleaning And Disinfecting

    If soiling or more stubborn stains exist, use a non-abrasive cleaning agent and apply with a damp, not wet, cloth. Follow the manufacturer’s recommended instructions supplied with your chosen cleaning agent or disinfectant. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 2-9...

  • Page 25: Xstrahl 100 Operation

    3.1. Power On If the Xstrahl System has been installed with a connection to a mains isolator, the isolator needs to be placed in the On position (this is either a key operation or a mechanical switch). The location of the mains isolator will vary between sites and is customer dependent (established during installation process).

  • Page 26: System Warm-Up

    2. Double click the icon (either Fisica or Concerto). Both Xstrahl software applications provide the ability to conduct a system warm-up. If there is a problem with the communication between the PC and TP2 hardware, an error dialog will be displayed.

  • Page 27: Interrupting An Exposure During The Beam Ramp Up

    This can be seen in the ‘actual’ kV and mA values on the exposure screen. Operator name must be at least three alphanumeric characters. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 3-3...

  • Page 28: Power Down Procedure

    3.4. Power Down Procedure The Xstrahl X-Ray Therapy System can be left powered on with the operator pod key switch in standby (position 2). During the clinical session this leaves the system with mains power. The key should be removed if the machine is left unattended;...

  • Page 29: Concerto

    ® Concerto ® Concerto is the clinical interface for the Xstrahl system. Concerto enables the operator to create patients, define treatment parameters and deliver exposures, record values to a database and print hard copy patient reports. The Concerto interface can be used without the X-Ray system being powered on, which can be useful for data housekeeping.
  • Page 32 System Error Table ............ 5-3 ____________________________________________________ System Errors Xstrahl system errors are displayed on the bottom right side of the exposure screens in Concerto and Fisica. Types of Errors Will persist whilst the problem exists; for example, a filter...
  • Page 33 Generator error. Displayed if the decay of the kV at the end of the exposure takes too long. The X-Ray Decay too Slow system status will remain as X-Ray ON until the kV threshold is reached. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 5-3...
  • Page 34 Generator error. Displayed in bipolar systems when the anode tank mA fails to Anode Under mA reach the desired value within a defined period of time. Latching error. 5-4 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...
  • Page 35 Power Up Displayed if the X-Ray beam is stopped by the door contact being open. Latching error Shutdown by Safety1 requires a new X-Ray ON signal to be reset. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 5-5...
  • Page 36 Generator error. Displayed if the generator receives an X-Ray ON initiation, but the X- X-Ray Off I/O Problem Ray OFF interlock line is not enabled (sourced with current). 5-6 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...
  • Page 37 Displayed if the TP2 fails to read data from LCD Failure the LCD. This error will persist until rectified. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 5-7...
  • Page 38 Time and Dose Stopped by Backup Timer treatments. No further exposure is allowed. X-Rays ON will be allowed, but termination will be repeated as soon as the timer starts. 5-8 | 06/04/2018 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All Rights Reserved...
  • Page 39 The error is not resettable. Fatal error No Real Time Clock NOT USED Displayed if an internal processor clock Processor Clock Fault fault arises. The error is not resettable. Fatal error. 100_OPMAN_GB Version 9 ©2017 Xstrahl Ltd. All rights reserved 06/04/2018 | 5-9...
  • Page 42 Worldwide Xstrahl Limited Xstrahl Technical Support The Coliseum Unit 2, Maybrook Industrial Estate Watchmoor Park Maybrook Road Riverside Way Walsall Wood, Brownhills Camberley West Midlands, WS8 7DG Surrey GU15 3YL t: +44 (0) 1543 688920 t: +44 (0) 1276 462696...

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