Varex Imaging Optica 30 Series User Manual
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Varex Imaging Optica 30 Series User Manual

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Download this manual See also: Technical Manual
Optica 30
Optica 40
Optica 50
Optica 30/40/50 series
0120
User Manual
UM50566-EN, Revision: 3.0
www.vareximaging.com

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  • Page 1 Optica 30 Optica 40 Optica 50 Optica 30/40/50 series 0120 User Manual UM50566-EN, Revision: 3.0 www.vareximaging.com...

  • Page 2: Table Of Contents

    Table of Contents Introduction ............................4 1.1. Contact information .........................4 1.2. Symbols used in this document ....................4 1.3. Abbreviations ..........................5 1.4. Advisory...........................5 1.5. Radiation danger ........................5 1.6. General warnings, cautions and notes ..................6 1.7. Labels and markings on the device ..................7 1.8.
  • Page 3 Although this guide is prepared with utmost care, Varex Imaging Nederland B.V. assumes no responsibility for errors or omissions. Varex Imaging Nederland B.V. cannot be held accountable for damages of any nature arising from the use, and / or use of any options other than original Varex Imaging Nederland B.V. products.

  • Page 4: Introduction

    Dear Customer, thank you for choosing a Collimator that is designed, manufactured and marketed by: Varex Imaging Nederland B.V. If you need additional information, need support or want to report a problem with the Collimator, please contact your distributor or Varex Imaging Nederland B.V.. Manufacturer Distributor Name Varex Imaging Nederland B.V.

  • Page 5: Abbreviations

    Information regarding accidents that have occurred using the Optica 30/40/50 series must be reported to Varex Imaging Nederland B.V. immediately. Varex Imaging Nederland B.V. is not liable if the provided instructions are not complied with. Varex Imaging Nederland B.V. is not liable if one or more of the following cases apply: •...

  • Page 6: General Warnings, Cautions And Notes

    Any change or modification carried out by unauthorized personnel may introduce serious hazards. When changes or modification are carried out by unauthorized personnel, Varex Imaging Nederland B.V. cannot be held responsible for injuries or damage to equipment. WARNING: Disconnect power supply before opening collimator.

  • Page 7: Labels And Markings On The Device

    CAUTION: The collimator is not intended for sterilization. NOTE: Always keep this manual and read it before using the collimator. NOTE: Please contact your distributor or Varex Imaging Nederland B.V. when the product label or other markings on the outside of the collimator are missing.
  • Page 8 Symbol Explanation Identification of compliance with the provisions for EU WEEE directive DC supply voltage indication. Protective earth. Follow the instructions for use Reading the instructions for use is crucial for a correct and safe use of the collimator Warning: Laser emission, possibly hazardous optical radiation emission (optional feature) OVERTURE Warning: Identifies the exit point of the laser beam (optional feature)
  • Page 9 Symbol Explanation Tilting angle. Setup collimator. << Return to previous screen. Accept numeric keyboard value. Cancel numeric keyboard value. < Delete entered digit on numeric keyboard. Restart collimator. When displayed in an error message: >> Continue to use the collimator with limited functionality User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0...

  • Page 10: Supplied Components

    Otherwise, you should immediately contact your distributor or Varex Imaging Nederland B.V.. It is highly recommended to always use the original packaging during transport and for return shipments. See §6 for storage conditions if the device is not used directly.

  • Page 11: Device Description

    2. Device description Intended use 2.1. The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics. The device is intended to be used as accessory of an X-ray system in a professional healthcare facility environment. The device is intended to restrict the dimensions of a diagnostic X-ray field by limiting the primary X-ray beam.

  • Page 12: Known Contraindication(S)

    Known contraindication(s) 2.5. Contraindications of the X-ray system continue to apply (see X-ray system documentation). Additional the Optica 30/40/50 series introduces matter in the primary X-ray beam which primarily results in additional X-ray scatter. Additional X-ray scatter causes a radiation risk. The Optica 30/40/50 series is mitigating the radiation risk by shielding the additional scatter and limiting the size of the primary X-ray beam and also confining the scatter generated from the X-ray tube (housing).

  • Page 13: Bucky Laser

    SID. Applied parts 2.9. The Optica 30/40/50 series do not have applied parts. 2.10. Accessories Be advised by your distributor or Varex Imaging Nederland B.V. for any accessories available. User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 13/36 www.vareximaging.com...

  • Page 14: Classifications

    2.11. Classifications Subject Classification Reference Electrical safety classification Class I IEC 60601-1 Applied Part Not applicable IEC 60601-1 Mode of operation Continuous operation IEC 60601-1 Ingress protection classification IP20 IEC 60529 Laser classification Class 2 IEC 60825-1 Field light classification Risk Group 2 IEC 62471 Not intended for use in Oxygen Rich environment.

  • Page 15: Operating Instructions

    3. Operating instructions Powering ON and OFF 3.1. POWER ON: When the power supply to the collimator is switched ON, the collimator performs a power-ON self-test for important functions of the collimator. During the power-ON self-test (which takes a few seconds), the status LED is flashing green (Optica 30/40 Series only). A Start-Up screen is displayed on the touch screen (Optica 40 Series only).
  • Page 16 The collimator shows a popup error message on the touch screen (Optica 40 Series only). WARNING: only the first detected fault condition is displayed on the touch screen. WARNING: It is important to send the following information to Varex Imaging Nederland B.V. for analysis: •...

  • Page 17: Status Led Color

    Status LED color 3.2. The status LED indicates the Collimator modes (Optica 30/40 Series only). The table below explains the status LED indications. During the POWER-ON self-test and normal OPERATING MODE, the collimator software can detect fault conditions see §3.3 Collimator Color of the Explanation of the color indication...

  • Page 18: Error Codes And Troubleshooting

    Error codes and troubleshooting 3.3. The table below shows error codes and actions for troubleshooting. For Optica 40 series the codes are displayed on the touch screen. Error code Description Troubleshooting 1 - 49 POWER ON self-test fault. Restart the collimator by selecting the fault condition message.

  • Page 19: Collimator Functions During Operating Mode

    Collimator functions during OPERATING MODE 3.4. Optica 40 Series only Example for pre-set selecting SID to 100 cm User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 19/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 20 Example for manually selecting SID to 110 cm User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 20/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 21 Field size display and selection The field size is displayed in the left and right bottom corners of the touch screen. Indicated by the Long and Cross symbols on the Collimator front. The displayed value is only correct when the SID value is correctly entered.
  • Page 22 Method 3. Set the field size manually The field size X x Y can be selected manually in centimeters. User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 22/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 23 User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 23/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 24 Switching ON field light and Bucky laser WARNING: Always close the Bucky laser shutter (see §2.7) when no Bucky laser light function is needed. The collimator has a field light and Bucky laser for X-ray field indication. Both are switched ON and OFF simultaneously with the light button on the display or the button on the front panel.
  • Page 25 Collimator Operating mode The collimator can be used in MANUAL and AUTOMATIC operating mode. Actual settings are available through CAN-bus. The active operating mode is displayed on the touch screen as indicated in the picture below with the symbols described in the table. Symbol Definition MANUAL operating mode.
  • Page 26 Additional filter selection When the button for additional filters is pressed on the touch screen, a filter combination can be selected and will be displayed. Parameter default settings See the Technical Manual for instructions about changing of the default settings. Contact your service department.

  • Page 27: Emc Compatibility

    EMC compatibility 3.5. The device conforms to IEC 60601-1-2:2014 for EMC compatibility and must be used according to the EMC information provided in this manual. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.

  • Page 28: Troubleshooting, Maintenance And Service

    4. Troubleshooting, maintenance and service This chapter describes troubleshooting, cleaning, maintenance and service. 4.1. Troubleshooting Information about troubleshooting can be found in the Technical Manual. 4.2. Cleaning Cleaning procedures and agents Follow local, national and organizational procedures regarding cleaning. The following agents are safe to use: Agents Isopropanol...

  • Page 29: Disposal

    5. Disposal Disposal 5.1. This Collimator contains substances that can be hazardous to the environment and care should be taken when disposed of. The Collimator is marked with the following symbol: Follow national and local regulations regarding disposal of electronic equipment. Packaging material shall be recycled according national and local regulations.

  • Page 30: Technical Specification

    6. Technical specification Stainless steel, aluminium, copper, lead, brass, leaded Materials bronze, plastics (ABS) Power source 24 V DC ± 10% 35 VA (Optica 30/50 series only) Power consumption 80 VA (Optica 40 series only) X-ray rating up to 150 kVp Application Stationary equipment for radiography Collimation...

  • Page 31: Product Label

    SID precision of measurement with retractable tape < 2 % SID (EN60601-1-3: §8.5.2) Leakage radiation ≤ 0.5 mGy/h (At 1 m, X-ray beam = 150 kVp, 4 mA; EN60601-1-3: §12.4) Collimator rotation (+/- 90°) Optional with rotating flange Remote control interface Yes (via CAN bus) Maximum load for accessory rails 70 N...
  • Page 32 Anholtseweg 44 7091 HB Dinxperlo 0120 Only The Netherlands 710383 www.vareximaging.com Medical Device Model: OPTICA XX XXXXX-NN-LLL 24 VDC / 35VA XXXXXXXXXXXX Min. inherent filtration YYYY-MM-DD Al. Equi v .: 1.2mmAl / 75 kV X-ray rating up to: 150 kVp IP20 (01)0XXXXXXXXXXXX(11)XXXXXX(21)WOXXXXXX/E-XX This product complies with the requirements of 21 CFR Subchapter J for radiation emitting products in effect on the date of manufacture.
  • Page 33 (This page is intentionally left blank) User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 33/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 34 (This page is intentionally left blank) User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 34/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 35 (This page is intentionally left blank) User Manual: UM50566-EN Optica 30/40/50 series Revision: 3.0 35/36 www.vareximaging.com Date of release: 2019-01-09...
  • Page 36 +63 2 8076 472 China.CNC@vareximaging.com Philippines.CNC@vareximaging.com © 2018 by Varex Imaging Nederland B.V. All Rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of Varex Imaging Nederland B.V.

This manual is also suitable for:

Optica 50 seriesOptica 40 series

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