Canon DelftDI LLS-1 User manual

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

User Manual: LLS-1
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Blank Page

User Manual: LLS-1
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List of revisions
Equipment
LLS-1
Document
User manual
Document number
ODB-118-5070ENG
revision
Date
Comment
00
05-12-2017
First version
01
12-02-2018
Add new wall locking system
02
07-09-2018
Correction of WEEE symbol
03
17-06-2019
Add Name Single Shot Long-Length, warning label, alignment instructions,
specs and 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. [phone]
Fax. [phone]
E-mail: [email protected]
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 from Oldelft Benelux B.V. Reproductions,
either in part or in whole, may not be published or copied in any manner, without the explicit
written consent of Oldelft Benelux B.V.

User Manual: LLS-1
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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.

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Symbols
Symbol
Meaning
Remarks
Location: Near or on the
type identification plate.
Symbol for separated collection of electrical
and electronic equipment per Directive
2002/96 of the European Parliament and
the Council of the European Union
(Directive on Waste of Electrical and
Electronic Equipment - WEEE). If applicable
to the type of device, it indicates legally
imposed obligations within EU member
states, Iceland, Norway and Switzerland
when the equipment is disposed of, at the
end of its life-time.
Owners of marked equipment should
contact the organization that imported
the equipment into their country, when
they want to dispose of the equipment,
at the end of its lifetime. The Directive
prioritizes re-use of equipment over re-
use of components over re-use 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
Applied Part according to EN60601-1.
Consult Instructions for Use
Consulting the accompanying documents is
a mandatory action.
General warning sign
Placed together with a supplementary
symbol or text. The text associated shall
be an affirmative statement (i.e., a
safety notice) describing the principal
risk(s) foreseen (e.g. “Causes burns”,
“Risk of explosion”, etc.).
The CE Mark is a declaration by the
manufacturer that the product complies with
the requirements of the applicable
European Union (EU) medical device
directive and that the product has been
subject to conformity assessment
procedures as provided in that directive.

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Conventions
The LLS-1 has been designed to meet all safety requirements applicable to medical
equipment. However, anyone using the LLS-1 must be fully aware of potential safety
hazards. The information contained in this chapter is provided to help users to
operate the LLS-1 safely.
Throughout this manual certain conventions are used. These are Warnings, Cautions
and Notes. They provide a means of prioritizing information to be brought to the
attention of the user. Warnings, Cautions and Notes will also be used throughout this
manual in the following manner:
WARNING:
Indication of an important warning that is to be obeyed to eliminate the
risk of personal injury or an incorrect clinical diagnosis.
CAUTION:
Indication of important information to avoid serious system equipment
damage.
Note:
Additional information for reader understanding or simplification of a
task.
Precautions
The user is expected to use the product (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
with safety instructions 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 class: Class II MD, to avoid the risk of electric
shock, this equipment is double isolated (two levels of protection).
Connection to a supply main with protective earth is not required.
WARNING:
The user shall take care that potential electromagnetic or other
interferences between the unit and other equipment is avoided. If
necessary certain actions must be taken.

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WARNING:
Do not modify any part of Oldelft Benelux supplied hardware, software or
software configuration. Any modification, installation or running an
application that has not explicitly been approved by Oldelft Benelux may
compromise patient safety and will result in termination of all warranty and
service contracts.
a. If this equipment is modified, repaired or maintained, appropriate
inspection and testing must be conducted to ensure continued safe
use of the equipment.
b. Do not leave problems unattended that may affect the safety of the
product. In case you have doubts concerning the LLS-1 save
operation, call the service number of your vender for further
instructions.
c. The LLS-1 stand should be cleaned regular to prevent the
accumulation of dust. The contact surface should be cleaned after
each patient for hygienic reasons.
WARNING:
The Oldelft Benelux products are designed for use and maintenance using
only parts available from Oldelft Benelux. No liability for failure can be
accepted by Oldelft Benelux through the use of parts obtained 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 contained in this publication is subject to change without notice.
Whenever the equipment is delivered with a documentation medium such as a CD
or DVD, the user shall always check the medium for latest information. This
information is part of Release Notes and Document Upgrade files.
Neither Oldelft Benelux B.V. and its subsidiaries nor anyone else who has been
involved with the development, production or delivery of the documentation be
liable for any special, incidental or consequential damages, whether based upon
breach of warranty, breach of contract, negligence, strict liability in tort or any
other legal theory.
This manual was originally drafted in the English language.
Note:
Any serious incident with the user and/or patient that has occurred in
relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is
established.

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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

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Introduction
1.1 About this manual
This user manual is a guide for the operator of the LLS-1, a Long-Length X-ray
system. In this manual it is assumed that the operator is a professional and trained X-
ray user, who has gained sufficient knowledge to operate LLS-1 safely.
In particular this document describes 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 patient and the patient can be immediately
released from the LLS-1.
The system meets the relevant provisions of the European Medical Device
Regulation (EU) 2017/745 (MDR).

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1.3 Identification label
Label
Location

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General description
2.1 Description of the device
Product / Trade name: LLS-1
The LSS-1 is also referenced as:
•One Shot Long-Length imaging Stand
•Single Shot Long-Length Imaging Stand
The LLS-1 is available in two variations.
•Detectors CXDI 410C
•Detectors CXDI 710C
Product description
The LLS-1 is a single product, produced 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 total length of the
spine or the legs. No stitching of three separate images is longer required. The x-ray
image can be taken in one shot.
Images: LLS-1
LSS-1 Stand + 45°
LSS-1 Stand - 45°

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LSS-1 Stand with UP/Down Movement
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.

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2.2 Principles of operation of the device
principles of operation of the device: The LLS-1 stand is intended to hold three
Canon detectors in order to be able to make a Long-Length X-ray image in one shot,
and to support the patient retaining a stable vertical position.
To perform a Long-Length X-ray image in one shot the LLS-1 needs to be positioned
against the wall in the X-ray examination room. The X-ray beam must be able to
cover the whole Field of View on the LLS-1. The Film Focus Distance (FFD) must be
> 2.0m, depending of the used collimator. Normally this 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 can be taken in
one shot. The images from the three different X-ray detectors are automatically
combined to a one-shot image.
The Canon Detectors 3x-CXDI 410C Wireless (42x43cm) or 3x CXDI-710C Wireless
(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.

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2.3 Intended purpose and patient population
Intended Purpose: The LLS-1 stand is intended to hold three Canon detectors
in order to be able to make a Long-Length X-ray image in a
single shot, and to support the patient retaining a stable
vertical position.
Variants: The LLS-1 is available in two versions.
•CXDI 410C Wireless (42x43cm).
•CXDI-710C Wireless (35x43cm).
Accessory: There are no accessories
Intended indication: General Radiography.
For taking X-rays images where the Field of View (FoV) is
greater than the FoV of one detector and it’s important that
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 professional radiographers.
Patient Population: There are no restrictions in patient population.
Duration: Transient. Even when the device is used more than once
on the same patient, the total duration will not exceed
transient use.
Intended environment: Dedicated X-ray room, in medical institutions.
Non-invase device: The device is non-invasive by its nature.
Active medical device: The device is an active medical device.

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Instructions for Installation
WARNING:
This product was designed and manufactured to ensure maximum safety
of use. It should be installed and serviced in strict compliance with the
instructions described in this Document.
WARNING:
If the Stitch Frame U package is open or damaged inspect the product on
damage and inform the distributor.
WARNING:
If the Stitch Frame U seems to be broken or damaged DO NOT install or
use it.
3.1 Material required
No special materials required
Tools required
Measuring tape
5m
Spirit level
marker
Drill & Drill 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.
Please contact your distributor immediately if parts are missing or damaged.
Table of contents
item
Description
Details
1
LSS-1 Assembly
1x
2
Power Cord
1x
3
Hand Controller
1x
5
Wall bracket LLS-1 stand
2x
To lock the stand
6
Mounting material Wall brackets LLS-1
stand
1 set
7
Wall brackets Grid
1 set
To hang the grid when not used in
the docking.
8
Mounting material Wall brackets Grid.
1set

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Setting up of the Wall bracket LLS-1 Stand
•Position the LLS-1 on the supposed
position and center the LLS-1 stand in
relation to the X-ray 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.

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•Remove the LLS-1 brackets and drill the Holes with an 8mm stone bit.
•Clean all the dust and debris from the holes and floor.
•Install Nylon Fixing Plugs into the holes and mount the wall brackets to the wall.
•Finally: Install the LLS-1 and check the centering in relation to the X-ray field.
•Position the LSS-1 stand in the wall brackets and lock the front wheels from the stand.
•Check the fixation 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 stand.
•Mount the lower bracket (2) with the
upper side 80cm from the lower side of
the upper bracket (1)
•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 stand.

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Install Detectors in the Docking
•The LLS-1 stand is prepared to work with two types Canon detectors.
oCXDI-410C Wireless detector.
oCXDI-710C Wireless detector.
•The following steps needs to be done to mount the detectors in the right way.
WARNING:
While 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 Bay.
•If the lower side fits in the bay rotate the detector
totally in the bay and lock it with the detector
latch.

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•Install the detectors in the right order starting with
o1 (middle)
o2 (lowest)
o3 (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.

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Instructions for Use
4.1 Precautions
The user is expected to use the product (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 with safety
instructions 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 class: Class II MD, to avoid the risk of electric shock, this
equipment is double isolated (two levels of protection). Connection to a
supply main with protective earth is not required.
WARNING:
The user shall take care that potentional electromagnetic or other
interferences between the unit and other equipment is avoided. If necessary
certain actions must be taken.