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Summary of Contents for Xstrahl RADiant
- Page 1 RADiant Therapy System Operator Manual Language: English...
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Page 3: About Us
Xstrahl’s range of X-Ray therapy systems are classified as Class IIb Medical Devices in accordance with the Medical Devices Directive. RADiant has clearance by FDA for sale in the U.S.A and is manufactured in accordance with ISO13485:2003 certified quality management system. -
Page 4: File No., Revision, Year
All manufacturer tradenames and trademarks appearing in this document are hereby acknowledged. Referenced Not all documents referred to in this document are part of the scope of delivery for the equipment. Xstrahl reserves the right to determine Documents the documents delivered with the product. Compatibility/Contra... -
Page 5: Electromagnetic Compatibility
About Xstrahl RADiant Operator Manual Electromagnetic The Xstrahl Radiotherapy systems are suitable for use in a clinical or 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: 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. -
Page 7: Specific Hazards
About Xstrahl RADiant Operator Manual 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:... -
Page 8: Quality Assurance
RADiant Operator Manual About Xstrahl Quality Assurance The RADiant 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 9: Intended Use (Of Equipment)
About Xstrahl RADiant Operator Manual Intended Use (of The Xstrahl RADiant Therapy System is a low energy X-ray system equipment) intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Typical applications include treatment for Basal Cell Carcinoma,... - Page 10 RADiant Operator Manual About Xstrahl viii | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 11: Table Of Contents
Inserting the Applicator ......................2-5 2.3.2 Removing the Applicator ......................2-6 2.3.3 Cleaning the Applicators ......................2-7 RADiant Therapy Base Unit Tube Stand ................. 2-7 2.4.1 Movement Controls ......................... 2-8 2.4.2 The Support Arm ........................2-8 Warning Lights and Door Interlock ..................2-10 Cleaning and Disinfecting ..................... - Page 12 RADiant Operator Manual About Xstrahl Power Down Procedure ......................3-3 ® Concerto ..........................4-1 Overview ..........................4-1 5 System Errors ........................5-1 System Error Table ........................5-2 x | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 13: List Of Figure And Tables
Figure 2-4: RADiant Therapy filter being fitted ................. 2-4 Figure 2-5: RADiant Therapy Applicator ................... 2-5 Figure 2-6: RADiant Therapy system applicator being fitted ............2-6 Figure 2-7: RADiant Therapy system applicator fitted ..............2-6 Figure 2-8: RADiant Therapy System Base Unit ................2-7 Figure 2-9: Brake Button ........................ - Page 14 RADiant Operator Manual ii | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 15: Preface
RADiant Operator Manual Preface This is the Operator Manual for the Xstrahl RADiant System. This manual provides the information a medical operator requires to operate the Xstrahl RADiant. 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 RADiant. - Page 16 RADiant Operator Manual iv | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 17: 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. PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved... -
Page 18: 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 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved... -
Page 19: Xstrahl Radiant System Description
______________________________________________________ Xstrahl RADiant System Description The RADiant Therapy system is a superficial X-Ray therapy system producing X-Rays up to 80kV. 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 20 Treatment Room Controller X-Ray System (Base Unit) Warning Lights By Access Door to Treatment Room Door Interlock Control POD Control Room PC Computer Figure 2-2: RADiant Therapy System 2-2 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 21: Operator Interface
The Xstrahl RADiant Therapy system comes with interlocked filter. Figure 2-3: RADiant Therapy System filter Each Xstrahl RADiant Therapy system can have up to 9 standard filters — clinical filters and one warm-up filter. The system uses encoding to detect treatment filters fitted within the machine head. -
Page 22: Filter Settings
RADiant Operator Manual Section 2: Xstrahl RADiant System Description The Xstrahl RADiant Therapy filter is made of aluminium and be up to a maximum physical thickness of 3mm. The materials and thickness, in combination with the kV for the clinical filter, give a resultant HVL as measured by the physicist;... -
Page 23: Applicators
Two hands should be used when carrying the applicator for insertion. The identification of each applicator is engraved on the top side of each applicator Table 2-3: Xstrahl RADiant Therapy range of applicators RADiant Therapy Applicators eBt Standard Applicator Set... -
Page 24: Removing The Applicator
RADiant Operator Manual Section 2: Xstrahl RADiant System Description Figure 2-6: RADiant Therapy system applicator being fitted 3. Push the applicator fully into the sub-tube assembly. It is not possible to rotate the applicator within the sub-tube assembly. Figure 2-7: RADiant Therapy system applicator fitted 2.3.2... -
Page 25: Cleaning The Applicators
Xstrahl Limited before using on the applicators. RADiant Therapy Base Unit Tube Stand The Xstrahl RADiant Therapy tube support is mounted on a base unit. The unit provides power distribution, generator control and power to tube stand peripherals. -
Page 26: Movement Controls
CAUTION: Never try to force a movement of the arm without first releasing the brakes WARNING: When carrying out movements with the RADiant Therapy system, avoid colliding with objects or persons within the room. Familiarise yourself with fixed collision hazards... - Page 27 Once the machine has been moved into position, the foot brake can be applied to prevent wheel movement. At the end of the clinical session, the foot brake can be released, and the base unit moved to a storage position. PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 12/02/18 | 2-9...
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Page 28: Warning Lights And Door Interlock
RADiant Operator Manual Section 2: Xstrahl RADiant System Description Warning Lights and Door Interlock The RADiant Therapy System has warning lights on access to the treatment room. Controlled Area X-rays illuminated (Yellow) when the system is powered. Do Not Enter illuminated (Red) and flashing when X-rays are on. -
Page 29: Cleaning The Applicators
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. Service Life and Disposal The X-ray tube contains a beryllium window. At the end of the useful life of the X-Ray tube (with Be-window) must be disposed in accordance with your local regulations. - Page 30 RADiant Operator Manual Section 2: Xstrahl RADiant System Description 2-12 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 31: Xstrahl Radiant Therapy System Operation
80% ambient relative humidity (non-condensing). 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. The location of the mains isolator will vary between sites and is customer dependent (established during installation process). -
Page 32: 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 33: Interrupting An Exposure During The Beam Ramp Up
1. Operator name must be at least three alphanumeric characters. 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 PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved... - Page 34 The key should be removed if the machine is left unattended. After the last exposure of the day has been conducted, the Xstrahl System should be powered down, however the main isolator does not have to be switched off.
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Page 35: Concerto
® Concerto Overview 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 36 RADiant Operator Manual 4-2 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
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Page 37: System Errors
RADiant Operator Manual 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 Normal Errors Will persist whilst the problem exists; for example, a filter encoding error will remain until the correct filter is fitted. -
Page 38: System Error Table
Generator error. Displayed if the decay of the X-Ray Decay too Slow 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. 5-2 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved... - Page 39 Latching error. Generator error. Displayed in bipolar systems Anode Under mA when the anode tank mA fails to reach the desired value within a defined period of time. Latching error. PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 14/11/2018| 5-3...
- Page 40 Power Up Displayed if the X-Ray beam is stopped by the Shutdown by Safety1 door contact being open. Latching error requires a new X-Ray ON signal to be reset. 5-4 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
- Page 41 Generator error. Displayed if the generator X-Ray Off | / O Problem receives an X-Ray ON initiation, but the X-Ray OFF interlock line is not enabled (sourced with current). PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 14/11/2018| 5-5...
- Page 42 This error will persist until a compliant dose is entered. Displayed if the TP2 fails to read data from the LCD Failure LCD. This error will persist until rectified. 5-6 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
- Page 43 The calculation of the limit will vary between Time and Dose treatments. No further exposure is allowed. X-Rays ON will be allowed, but termination will be repeated as soon as the timer starts. PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved 14/11/2018| 5-7...
- Page 44 Fatal error NOT USED No Real Time Clock Displayed if an internal processor clock fault Processor Clock Fault arises. The error is not resettable. Fatal error. 5-8 | 14/11/2018 PHET_OP_GB Version 7© Xstrahl Ltd. All Rights Reserved...
- Page 46 Worldwide Xstrahl Limited Xstrahl Technical The Coliseum Support Watchmoor Park Unit 2, Maybrook Riverside Way Industrial Estate Camberley Maybrook Road Surrey GU15 3YL Walsall Wood, Brownhills t: +44 (0) 1276 462696 West Midlands, WS8 e: support@Xstrahl.com www.xstrahl.com t: +44 (0) 1543 688920 United States Xstrahl Inc.
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