Varex Imaging Optica 20 Series User Manual Download Page 1

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UM50589-EN, Revision: 4.0

www.vareximaging.com

Optica 20 series

User Manual

Summary of Contents for Optica 20 Series

Page 1: ...UM50589 EN Revision 4 0 www vareximaging com Optica 20 series User Manual ...

Page 2: ...User Manual UM50589 EN Optica 20 series Revision 4 0 Date of release 2019 01 23 2 20 www vareximaging com This page is deliberately left blank ...

Page 3: ...essories 11 2 6 Aluminium attenuation equivalence 11 2 7 Restrictions on use 11 2 8 Essential performance 11 2 9 Applied parts 11 2 10 Known contraindication s 11 2 11 Classifications 11 2 12 Installation 11 3 Operating instructions 12 3 1 Switching the device ON and OFF 12 3 2 Overview general Optica 20 controls 12 3 3 Bucky line laser 15 3 4 Filter module 15 4 Quality Assurance 16 5 Maintenance ...

Page 4: ...x Imaging Nederland B V products Warranty The product has the warranty provisions of our general conditions The warranty on your equipment will be void if Service and maintenance are not carried out according to the instructions and if repairs are not performed or performed without proper validation Changes or modifications made without our prior written consent Non original parts or other than th...

Page 5: ...2 Abbreviations acronyms and definitions Term Definition Collimator Optica 20 series X ray Collimator Optica 20 Optica 20 series X ray Collimator SID Source Image Distance The distance from the source of radiation the focal spot of the x ray tube to the film or other image receptor Synonym Focal Film Distance FFD RF Radio Frequency 1 3 Symbols used in this document To ensure adequate and clear und...

Page 6: ...of the following cases apply Modification or repairing of the Optica 20 series in any way other than described in this manual Use of the Optica 20 series other than the INTENDED USE The Optica 20 series is not subjected to regular inspection and maintenance Use of the Optica 20 series in a way which could not be reasonable foreseen by Varex Imaging Nederland B V Direct or indirect damage which are...

Page 7: ...and B V cannot be held responsible for injuries or damage to equipment WARNING The collimator shall only be used with specified conditions listed in chapter 7 WARNING The temperature of the enclosure can become more then 41 C WARNING Preventive checks see Technical manual TM50590 shall be carried on a regular basis The interval of these checks shall be tailored to the application and frequency of ...

Page 8: ...acturer Date of manufacture Serial number Catalogue number 0120 CE mark directive 93 42 EC conformity assessment by notified body 0120 optional feature 710383 SGS recognized component for US Canada registration number 710383 optional feature Identification of compliance with FCC 47 CFR Part 15 optional feature CAUTION Federal law restricts this device to sale by or on the order of a physician opti...

Page 9: ...tly The packaging contains the following components Amount Description Reference 1 Optica 20 series Standard Model DC input Standard Model DC input Filter module Standard Model ACDC input Standard Model ACDC input Filter module 50250 1N LLL 50251 1N LLL 50600 1N LLL 50601 1N LLL 1 Document Kit Contains 1 User Manual 1 Technical Manual 1 Strain relief 1 Top shutter caliber 1 ECDoC 50771 LLL The cat...

Page 10: ...size of the direct X ray exposure to the patient and for reducing the scattered radiation The Optica 20 series contains a LED for indication of the actual field to be exposed and optional has a laser line for alignment with the Bucky For measuring the SID a measuring tape is integrated Additionally a filter module can be integrated for extra filtering of the X ray beam see 1 8 2 3 Principle of ope...

Page 11: ...ontinue to apply see X ray system documentation Additionally the Optica 20 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 20 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 gene...

Page 12: ...system is powered on The Optica 20 series can be powered off at any time without causing damage to the device 3 2 Overview general Optica 20 controls Layout and units of the graphics is depending on the Optica 20 series model and can be different from the pictures below A Knob for moving shutters in cross direction B Knob for moving shutters in long direction Turn the applicable knob in direction ...

Page 13: ...e into account that a read inaccuracy can occur since it is an approximate and optical read out D Push button for activating laser line for Bucky alignment optional feature The laser will be activated for a pre defined time and will switch off automatically Push the button for 2 seconds to switch off the laser A green indication LED will light inside the button Pay attention In case the collimator...

Page 14: ...maximum value can cause breakage and or distortion of the tape Always guide the measuring tape back to its start position sudden release of the measuring tape can cause damage to humans the tape itself and or collimator housing G Accessory rails suitable for holding maximum of two accessories with outside dimensions of 176x176mm and a maximum thickness of 2mm in the cut out of the rail H Lock spri...

Page 15: ...ter disc Turn the disc clockwise or counter clockwise to select the required additional filter material the disc will snap lock once in the correct position The filter material is written on top of the disc for example see also print screen above and at the bottom of the disc the composition of the material is configured on request and can vary Also each position has an indication from 1 up to 4 l...

Page 16: ...ing Cleaning with a damp cloth is recommended Use neutral cleaning products and do not soak the device with liquid 5 4 Disinfection Disinfection with a damp cloth with Isopropyl alcohol is recommended Before using a disinfectant check at an inconspicuous spot on the device if the disinfectant will not damage the plastic and or coated metal surfaces Do not soak the device with liquid 6 Disposal and...

Page 17: ...they are operating normally WARNING Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and ho...

Page 18: ...ty 160 lx Light field X ray alignment 1 SID Light field edge contrast ratio 4 SID tape measure range 90 200 cm Field size Min 3x3cm 1m SID 1 2 x1 2 39 4 SID Max 43x43cm 1m SID 16 9 x16 9 39 4 SID Weight 8 kg Size WxDxH 230x267x177mm 9 1 x10 5 x7 0 Leakage 0 5 mGy h Filter module added filtration optional feature 1 mm Al 0 1 mm Cu 1 mm Al 0 2 mm Cu 2 mm Al None Operation environment Ambient tempera...

Page 19: ...ating 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 e ffect on the date of manufacture This product complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated July 26 2001 Medical Device Anholtseweg 44 7091 HB Dinxperlo The Netherlands www ...

Page 20: ... Varex Imaging Technology Beijing Co Ltd China t 86 10 6780 2708 t 86 10 6780 2129 f 86 10 6780 2170 China CNC vareximaging com Varex Imaging Philippines Inc Philippines t 63 49 5024 520 t 63 49 5024 521 f 63 49 5024 500 f 63 2 8076 472 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 b...

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