Xstrahl 150 Operator's Manual
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Xstrahl 150 Operator's Manual

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

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  • Page 1 Xstrahl 150 X-ray Therapy System Operator Manual Language: English...

  • Page 3: Notice Of Copyright

    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 ISO13485:2016 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

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

  • 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

    The Xstrahl 150 defines the exposure in time and does not measure Quality Assurance 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 Use (Of Equipment)

    Xstrahl® (100, 150, 200 and 300) X-Ray Therapy Systems are Intended Use (of intended to be used for radiation treatment of superficial skin equipment) 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

    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 ........................ 24 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved 15/01/2020...
  • Page 10 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved 15/01/2020 viii...

  • Page 11: List Of Figures

    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 .....................

  • Page 12: Preface

    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.

  • 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. 150_OPMAN_GB Version 10 © 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. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 15: System Description

    ______________________________________________________ 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.

  • 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: Figure 2-3: Filter Holder Illustration

    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.
  • Page 18 0.8 Al 1.4 Al 0.5 Al filtration 0.05 0.1 Cu 0.2 Cu 0.25 Cu (mm) a. The kV, mA and HVL values must be checked and recorded in the Acceptance Test Document. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 19: 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...

  • Page 20: Figure 2-5: Inserting The Applicator Illustration

    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®...

  • Page 21: Xstrahl 150 Tube Stand

    Xstrahl 150 Tube Stand Figure 2-6: Floor/Wall Mounted Xstrahl 150 Illustration The Xstrahl 150 can be supplied with a floor/wall mounted tube stand or on a ceiling track. Electromagnetic brakes lock the tube stand movements. These brakes can be released individually or in combination, by pushing the buttons located on the front panel of the X-Ray tube assembly.

  • Page 22: Xstrahl 150 Wall/Floor Stand Systems

    Figure 2-7: Movement Control Illustration Xstrahl 150 Wall/Floor Stand Systems Figure 2-8: Xstrahl 150 Brake/Movement Illustration 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 23 3. Release axial rotation clamp brake to lock See Brake/ Vernier Adjustment (Wheel) Movement There is a rotational wheel on the horizontal arm Illustration which allows the vertical height to be adjusted. The 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 24 Always reapply the brake to lock down the movement of the tube. See Brake/ Axial Rotation Clamp Brake Movement Controls the axial rotation. Use the axial rotation Illustration clamp brake to lock the axial rotation adjustment wheel. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 25: Xstrahl 150 Ceiling System

    2. Press at least one of the motion enable buttons to move the X-Ray tube longitudinally. 3. Release the motion enable buttons when the required longitudinal position is reached. 4. Release the longitudinal movement brake button to lock. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 26 Enables the tilt to be adjusted. Always release this Illustration brake gently to avoid the weight of the tube moving too quickly. Always reapply the brake to lock down the movement of the tube. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 27: Manual Height Override (Power Off)

    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. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 28 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 29: Xstrahl 150 System Operations

    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 established during the installation process.

  • Page 30: System Warm-Up

    After the system is powered on, a warm-up should be conducted. To conduct a warm-up: 1. Fit the warm-up filter and a small aperture applicator on the Xstrahl system. The Xstrahl system requires an applicator to be fitted to the sub-tube assembly, but does not require a specific applicator.

  • Page 31: Interrupting An Exposure During The Beam Ramp Up

    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 32 Turn the key switch on the operator pod to O (OFF) to shut down mains power from the controller. The Xstrahl system has an internal clock which records the time elapsed since the last exposure was conducted. The cooling system power will be Note: maintained until the shutdown delay value has elapsed.

  • Page 33: 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 34 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...

  • Page 35: System Errors

    Section 5: System Errors 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 Normal Errors filter encoding error will remain until the correct filter is...

  • Page 36: System Error Table

    Generator error. Displayed if the decay of the kV at the end of the exposure takes too long. The system status will remain as X-Ray ON until the kV threshold is reached. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 37 Latching error. Anode Under mA Generator error. Displayed in bipolar systems when the anode tank mA fails to reach the desired value within a defined period of time. Latching error. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 38 X-Ray ON signal to be reset. Shutdown by Safety2 Displayed if the X-Ray beam is stopped by the second door/room interlock contact being opened. Latching error requiring a new X-Ray ON signal to be reset. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 39 Interrupted by HS Temp Generator error. Displayed if an exposure is terminated by the heatsink thermostat. Latching error. Not Used Generator error. Displayed if the unipolar or bipolar tables are incompatible 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 40 This will prevent X- Ray ON. X-Ray On Light Failed Displayed if the external X-Ray ON lamp fails to draw current. This will terminate X- Ray ON. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 41 PC Data Interlock Displayed when the TP2 fails to receive a software interlock from the PC at less than one second intervals with the control pod key in HT (position 3). 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 42 The error is not resettable. Fatal error No Real Time Clock NOT USED Processor Clock Fault Displayed if an internal processor clock fault arises. The error is not resettable. Fatal error. 150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved...
  • Page 44 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 e: support@Xstrahl.com...

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