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Canon DelftDI LLS-1, User Manual

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Canon DelftDI LLS-1 User Manual Download Page 4

User Manual: LLS-1

 

 

 

 
 

 

ODB-118-0070ENG

 

Page 4 of 36

 

14-01-2022

 

Preface 

Identification 

 Manuals are identified by a part number. 

 

The part number is printed at the bottom of the title page. Numbers printed on other 
pages are for internal revision control and may differ.  

CE Classification  

Product meets the relevant provisions of the European MDR (EU 2017/745 - Medical 
Device Regulation); this is based on conformity of the products and the quality 
system according to ISO 13485:2016. 

 

 

Summary of Contents for DelftDI LLS-1

Page 1: ...User Manual LLS 1 ODB 118 0070ENG Page 1 of 36 14 01 2022 User manual LLS 1 Single Shot Long Length Imaging Rev 14 01 2022 draft ...

Page 2: ...User Manual LLS 1 ODB 118 0070ENG Page 2 of 36 14 01 2022 Blank Page ...

Page 3: ...nd small text updates 04 14 01 2022 Update to MDR storage temp Add specs Grid ODB 118 0070ENG Legal manufacturer Oldelft Benelux BV Wiltonstraat 41 3905 KW VEENENDAAL Tel 31 318 584 400 Fax 31 318 584 401 E mail info delftdi com Internet http www delftdi com All documentation of Oldelft Benelux B V is PROPRIETARY information and may not be forwarded to third parties without prior written consent f...

Page 4: ...ber is printed at the bottom of the title page Numbers printed on other pages are for internal revision control and may differ CE Classification Product meets the relevant provisions of the European MDR EU 2017 745 Medical Device Regulation this is based on conformity of the products and the quality system according to ISO 13485 2016 ...

Page 5: ... of materials over disposal as waste Article 5 part 2d allows producers to decline the return of any used equipment that is or may be biologically or radiologically contaminated Medical device Legal manufacturer Date of manufacture Serial number UDI code Unique Device Identification This mark indicated that this is CLASS II Equipment according to EN60601 1 This mark indicated that this is a Type B...

Page 6: ...soft and hardware in accordance with the instructions given in this manual which must be read before the system is used Any unauthorized deviation from the procedures laid down in this manual can affect the contractual obligations between purchaser and vendor WARNING This product was designed and manufactured to ensure maximum safety of use It should be installed and serviced in strict compliance ...

Page 7: ...ined from other suppliers unless written permission is obtained from Oldelft Benelux Copyright All rights reserved No part of this manual may be reproduced or transmitted in any form whatsoever including photocopying and recording without written permission of the copyright holder Oldelft Benelux B V Wiltonstraat 41 3961 KW VEENENDAAL The Netherlands Concerning this Publication Information contain...

Page 8: ...070ENG Page 8 of 36 14 01 2022 1 1 About this manual 9 1 2 Identification label 10 2 1 Description of the device 11 2 2 Intended purpose 14 2 3 Principles of operation of the device 13 4 1 Precautions 20 4 2 Use of the device 22 ...

Page 9: ...s the daily operation 1 2 Classification LLS 1 is classified according to Class I type B This mark indicated that this is CLASS II Equipment according to EN60601 1 Equipment with two levels of protection against electrical shock double insulation of live parts and touchable conductive casing This mark indicated that this is a Type B Applied Part according to EN60601 1 No Electrical contact with pa...

Page 10: ...User Manual LLS 1 ODB 118 0070ENG Page 10 of 36 14 01 2022 1 3 Identification label Label Location ...

Page 11: ...ced by Oldelft Benelux B V The LLS 1 is a positioning stand that forms with an X ray tube generator three flat panel detectors and acquisition computer a Long Length X ray system The system will be used as a Long Length X ray system with only the possibility to move the detector up and down depending on the length of the patient Typical application of Long Length X ray imaging is imaging of the to...

Page 12: ...ent LSS 1 Docking incl 3 detectors The Canon Detectors 3x 42x43cm or 3x 35x43cm don t need any interfacing with the X ray generator The detector system is equipped with Ultralight Automatic Exposure Detection AED for automatically triggering and acquire the image during the X ray procedure ...

Page 13: ...is is around 2 5m On this position wall brackets must be mounted on the wall so next time the LLS 1 is positioned properly and stable due the fixation on the wall The patient is positioned in front of the stand and can hold onto the handles to stand stable and as still as possible to avoid motion blur The Hight of the Docking and X ray beam can be adjusted to the Field of Interest The x ray image ...

Page 14: ...there is no movement while the X ray is being taken Making and merging of separately taken X rays images is no longer necessary because the image can be taken in one shot If the patient moves while recording the image moving blur will be introduced into the image The LLS 1 provides a stable position for the patient during an X ray procedure for patient picture improvement Intended Users Trained pr...

Page 15: ...rill bit 8mm screwdriver set 3 2 Unpacking and commissioning the LLS 1 Procedure WARNING Use at least two people to guide the LLS 1 stand of the ramp Remove the top and marked side panel of the case containing the LLS 1 stand Unpack all additional items and check if all items are included Use the marked side panel as ramp to the floor level Use at least two people to guide the LSS 1 of the ramp Pl...

Page 16: ...tube FFD 2 0m depending of the used collimator Position the Wall brackets between the LLS 1 stand and the wall Place temporally a spacer of 2mm between the stand and the wall brackets to ensure the stand can move in and out smooth Level the wall brackets Mark holes on the Wall Note check before drilling that the stand can move in and out smooth without touching the upper side of the wall brackets ...

Page 17: ...tion of the stand in the wall brackets to be sure that the stand stands stable Setting up of the Wall bracket grid Find a place in the room where the grid can hang safely Position the upper bracket 1 with the lower side at least 130cm from the floor Use a level to position the bracket horizontal Use a marker to mark the holes Mount the bracket to the wall as done with the wall brackets of the stan...

Page 18: ...closing the LLS 1 door after mounting the detectors or grid frame keep hands clear Unlock and open the LSS 1 docking using the two latches on the backside Rotate the latches a half turn CW Open the Docking Rotate the latches a half turn CCW When closing the Docking again this will automatically locked Open all detector latches as shown on the image Install the detector with the lower side in the B...

Page 19: ... detectors in the right order starting with o 1 middle o 2 lowest o 3 highest It s advised to use the systems preferred detector location Each detector is designated for a specific location within the frame Labeling the detectors with middle upper and lower is recommended ...

Page 20: ...ctions described in this Document WARNING Do not use the system before carefully study the user manuals it is assumed that the operator is a professional and trained X ray user or service engineer who has gained sufficient knowledge to operate the system safely WARNING Never attempt a shortcut to procedures which may degrade the safety considerations of the system WARNING Electrical protection cla...

Page 21: ...of a qualified technician WARNING For infection prevention is advised to disinfect the LSS 1 contact surface of the LLS 1 after each patient contact WARNING Always take radiation safety precautions The LLS 1 stand in its construction is planned to be used as a stand together with an X ray tube and 3 x ray detectors It is destined for transport in a clinic Before transportation the docking must be ...

Page 22: ...d in the Wall brackets Check the locking pin is positioned in the LLS 1 stand in position and fixates the LLS 1 stand to the wall 2x Note Rotating the locking pin can stop the pin from falling into the hole Lock the front wheels to secure the LLS 1 stand 2x Check the stability of the LLS 1 stand before starting the exam CAUTION Check the stability of the LLS 1 stand before starting the exam ...

Page 23: ... the stand for moving transport Move the Docking with the handset to the lowest position To unlock the LLS 1 stand pull the locking pin up and rotate the pin so it stays in the upper position 2x Note Rotating the locking pin can stop the pin from falling into the hole Unlock the front wheels The LLS 1 stand is ready to move ...

Page 24: ...sing the two latches on the backside Rotate the latches a half turn CW Open the Docking Slide the grid frame into notch on the bottom of the frame Tilt the grid frame upwards towards the lock Push the lock gently behind the lock bar Check if the grid frame is secured by the lock Removal of the grid frame can be done in reversed order ...

Page 25: ... CAUTION Check if the LLS 1 stand can move up and down without bumping against any obstacles Attach and remove the anti scatter grid Hand controller of the LLS 1 stand To change the height of the LLS 1 stand Press the appropriate button on the hand controller ...

Page 26: ... the proper height of the stand Align the X ray center beam on the horizontal centerline in the middle of the stand move the X ray tube up or down Collimate the target area Note To prevent overlap artefacts stay in between the center area with the X ray center beam FFD 2 0m depending of the used collimator Normally this is around 2 5m Note When using only 2 detectors Align the X ray center beam on...

Page 27: ...tart the examination Click Start Exam 3 Select the Single Shot LL type protocol Confirm that the indicator changes to in the system status Indicators and that a ready thumbnail appears in the target protocol 4 If the and indicators appear in the system status indicator check that Note The detectors are attached to the stand The cables are securely connected The power boxes are turned on ...

Page 28: ...e also Alignment patient LLS 1 and the X ray beam 6 Perform exposure Press and release the exposure switch of the X ray generator The indicator changes to and then to in the system status indicator The first image the second image and the third image are captured one after another The partial images are aligned and stitched automatically Then a stitched image appears on the image view pane Exposur...

Page 29: ...User Manual LLS 1 ODB 118 0070ENG Page 29 of 36 14 01 2022 Stitched Image ...

Page 30: ...d perform precise alignment on the Stitch Screen Note When the stitched image cannot be generated correctly after the detector receives some mechanical shock the calibration for stitching boundaries by service engineer is required Contact your sales representative or local Canon dealer for details 8 Finish the examination Click End Exam The image data will be transferred to a preset destination su...

Page 31: ...the wrong positions in a stand accidentally the stitched image is not generated correctly You can rearrange partial images manually and regenerate the correct stitched image 1 Rearrange partial images Click the thumbnail of the image in the wrong position drag it onto to the correct position and release the mouse button ...

Page 32: ...ated Preparing system for transportation For transportation of the LLS 1 stand follow the following steps Move the docking to their lowest position Disconnect the power cord Unlock the front wheels The LLS 1 is now ready for transportation to another location WARNING Before transporting the LLS 1 move the docking to their lowest position and disconnect the power cord ...

Page 33: ...ration is not possible any longer take the LLS 1 stand out of operation immediately and protect it against inadvertent operation Cleaning Stand Wipe the LLS 1 stand with a piece of soft cloth soaked in water containing neutral detergent and wrung dry DO NOT use abrasive or chemical agents as gasoline benzene acetone and carbon tetrachloride de icing fluids lacquer thinner or detergents containing ...

Page 34: ...ctor Suitable for Canon detectors CXDI 410C CXDI 710C Synchronized column movement allowing easy patient positioning up down Setup time 2 minutes Travel 60 cm Line power 100 240V 50 60Hz 450W Standby Power 0 1W Dimensions 107 4 x 69 1 x 144 3 204 3cm LxWxH and 60cm travel range Weight 92 kg Specifications GRID 1000 ASS 43x122cm Grid Ratio 10 1 Line 52 L cm Focal Distance Parallel Interspacer AL En...

Page 35: ...118 0070ENG Page 35 of 36 14 01 2022 8 1 Dimensions LLS 1 Stand height 1344 mm min 1944mm max travel range 600mm length 1074 mm depth 691 mm weight 92 kg Top View Front View Side view lower position Side View higher position ...

Page 36: ...2max 1 6max 0 05max 0 05max 0 05max Stainless steel RVS 304 K320 1 4301 stainless steel is a variation of the 18 chromium 8 nickel austenitic stainless steel the most familiar and most frequently used alloy in the stainless steel family This stainless steel be considered for a wide variety of application on good corrosion resistance ease fabrication excellent formability and high strength with low...

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