AGFA DR Full Leg Full Spine User manual

DR Full Leg Full Spine
User Manual
0179E EN 20210708 1527

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope of this Manual ..................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to the Full Leg Full Spine application ................. 9
Intended Use ............................................................10
Intended User .......................................................... 11
Configuration .......................................................... 12
Compliance ..............................................................14
General ........................................................14
System Documentation ............................................15
Accuracy of Measurements .......................................16
Product Complaints ................................................. 17
Labels ...................................................................... 18
Cleaning and Disinfection ........................................20
Maintenance ............................................................21
Environmental protection ........................................ 22
Safety Directions ......................................................23
Getting started .....................................................................25
Basic Features ..........................................................26
Basic Workflow using the DX Full Leg Full Spine Stand
27
Retrieve the patient info .............................. 28
Select the exposure ......................................28
Prepare the Full Leg Full Spine configuration ...
29
Prepare the examination ..............................32
Prepare the X-Ray system for the examination .
34
Check the exposure settings .........................35
Execute the exposure ................................... 37
Perform a quality control ............................. 38
Finalize the examination ..............................41
Basic Workflow using the FLFS Horizontal Overlay ....
42
Retrieve the patient info .............................. 43
Select the exposure ......................................43
Prepare the Full Leg Full Spine configuration ...
44
Prepare the examination ..............................46
Prepare the X-Ray system for the examination .
48
Check the exposure settings .........................49
Execute the exposure ................................... 51
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Perform a quality control ............................. 52
Finalize the examination ..............................55
Storing the FLFS Horizontal Overlay ............56
Advanced Operation ................................................ 57
Manually adjusting a DR Full Leg Full Spine image
..........................................................................58
Rejecting a DR Full Leg Full Spine image ......62
Making measurements .................................63
Problem solving ...................................................................65
Anatomical stitching is not optimal .......................... 66
Stitching fails ...........................................................67
Full Leg Full Spine examination is interrupted ......... 68
Part of the image is masked by the black border ....... 69
Bright area where partial images overlap ................. 71
Technical Data .....................................................................72
DX Full Leg Full Spine Stand .................................... 73
DX FLFS Horizontal Overlay .....................................74
DR 600 FLFS Horizontal Overlay ..............................75
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Legal Notice
Agfa NV, Septestraat 27, B-2640 Mortsel - Belgium
For more information on Agfa products, please visit www.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or
its affiliates. DX-D is a trademark of Agfa NV, Belgium or one of its affiliates.
All other trademarks are held by their respective owners and are used in an
editorial fashion with no intention of infringement.
Agfa NV makes no warranties or representation, expressed or implied, with
respect to the accuracy, completeness or usefulness of the information
contained in this document and specifically disclaims warranties of suitability
for any particular purpose. Products and services may not be available for
your local area. Please contact your local sales representative for availability
information. Agfa NV diligently strives to provide as accurate information as
possible, but shall not be responsible for any typographical error. Agfa NV
shall under no circumstances be liable for any damage arising from the use or
inability to use any information, apparatus, method or process disclosed in
this document. Agfa NV reserves the right to make changes to this document
without prior notice. The original version of this document is in English.
Copyright 2021 Agfa NV
All rights reserved.
Published by Agfa NV
B-2640 Mortsel - Belgium.
No part of this document may be reproduced, copied, adapted or transmitted
in any form or by any means without the written permission of Agfa NV
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Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
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Scope of this Manual
This manual contains information for the safe and effective operation of the
DR Full Leg Full Spine application and the following accessories:
• DX Full Leg Full Spine Stand
• DX FLFS Horizontal Overlay
• DR 600 FLFS Horizontal Overlay
DX FLFS Horizontal Overlay and DR 600 FLFS Horizontal Overlay are further
referred to as FLFS Horizontal Overlay, unless the information applies to a
specific type.
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About the safety notices in this document
The following samples show how warnings, cautions, instructions and notes
appear in this document. The text explains their intended use.
DANGER:
A danger safety notice indicates a hazardous situation of direct,
immediate danger for a potential serious injury to a user,
engineer, patient or any other person.
WARNING:
A warning safety notice indicates a hazardous situation which
can lead to a potential serious injury to a user, engineer, patient
or any other person.
CAUTION:
A caution safety notice indicates a hazardous situation which
can lead to a potential minor injury to a user, engineer, patient
or any other person.
An instruction is a direction which, if it is not followed, can
cause damage to the equipment described in this manual or any
other equipment or goods and can cause environmental
pollution.
A prohibition is a direction which, if it is not followed, can cause
damage to the equipment described in this manual or any other
equipment or goods and can cause environmental pollution.
Note: Notes provide advice and highlight unusual points. A note is
not intended as an instruction.
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Disclaimer
Agfa assumes no liability for use of this document if any unauthorized
changes to the content or format have been made.
Every care has been taken to ensure the accuracy of the information in this
document. However, Agfa assumes no responsibility or liability for errors,
inaccuracies or omissions that may appear in this document. To improve
reliability, function or design Agfa reserves the right to change the product
without further notice. This manual is provided without warranty of any kind,
implied or expressed, including, but not limited to, the implied warranties of
merchantability and fitness for a particular purpose.
Note: In the United States, Federal law restricts this device on order
of a physician for prescription use only.
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Introduction to the Full Leg Full Spine
application
Topics:
•Intended Use
•Intended User
•Configuration
•Compliance
•System Documentation
•Accuracy of Measurements
•Product Complaints
•Labels
•Cleaning and Disinfection
•Maintenance
•Environmental protection
•Safety Directions
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Intended Use
The intended use of the DR Full Leg Full Spine application is to provide a
workflow to acquire images for measurements in the orthopedic field
(skeleton).
Applications are performed with the patient in standing position using the DX
Full Leg Full Spine Stand or in lying position using the FLFS Horizontal
Overlay. The patient should not move during the examination to allow
accurate alignment of the X-ray images.
The DX Full Leg Full Spine Stand and the FLFS Horizontal Overlay are tools to
align multiple X-ray images during stitching by the image processing software.
The DX Full Leg Full Spine Stand will help the patient to stay in a fixed
position during the FLFS examination and separate the patient from the
moving DR detector.
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Intended User
This manual is written for trained users of Agfa products and trained clinical
personnel. Users are considered as the persons who actually handle the
equipment as well as the persons having authority over the equipment. Before
attempting to work with this equipment, the user must read, understand, note
and strictly observe all warnings, cautions and safety markings on the
equipment.
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Configuration
The DR Full Leg Full Spine application consists of following components:
• DR X-Ray system with automatic positioning
• NX Workstation
• DX Full Leg Full Spine Stand (type 6001/100)
• DX FLFS Horizontal Overlay (type 6001/200)
• DR 600 FLFS Horizontal Overlay (type 6001/220)
1
9
8
7
6
5
2
3
4
1. Stitching grid of the DX Full Leg Full Spine Stand
2. Handle of the DX Full Leg Full Spine Stand
3. Removable footstep
4. Collapsable footstep
5. Floor mount lock
6. Vertical ruler
7. Horizontal ruler
8. Patient belt
9. Knobs for attaching the patient belt
Figure 1: DX Full Leg Full Spine Stand
A protection shield must be added to the configuration in combination with
DX-D 300, to protect the patient from moving parts of the X-Ray system.
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Figure 2: Protection shield
2
2
1
1. Stitching grid
2. Ruler
Figure 3: FLFS Horizontal Overlay
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Compliance
General
• The DX Full Leg Full Spine Stand, DX FLFS Horizontal Overlay and DR 600
FLFS Horizontal Overlay have been designed in accordance with
Regulation (EU) 2017/745 on medical devices (MDR)
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System Documentation
The documentation shall be kept with the system for easy reference. The most
extensive configuration is described within this manual, including the
maximum number of options and accessories. Not every function, option or
accessory described may have been purchased or licensed on a particular
piece of equipment.
Refer to the System User Documentation before using the Full Leg Full Spine
application:
• User Manual of the DR system and related user documentation
• NX User Manual
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
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Accuracy of Measurements
Distance measurements on DR Full Leg Full Spine images in NX are displayed
with a resolution of one or more decimal places (such as 0.01 cm). You should
be aware that the real measurement accuracy is generally considerably lower
for a number of different reasons, many beyond the control of the product.
Distance measurements can be calibrated based on the Estimated
Radiographic Magnification Factor.
The measurement accuracy is limited by at least four factors:
• The quality and nature of the input data, including but not limited to the
accuracy of the calibration values.
• The user's ability to select appropriate points on the screen.
• The transformations inherent in generating images on a finite pixel
display.
• The stability of the patient during the examination.
It is the user’s responsibility to understand these limitations and to use the
measurement tools responsibly.
For the distance measurements on DR Full Leg Full Spine images, the accuracy
is 0.2 cm. The accuracy applies to the difference between the size of the
projection of the object on the stitching grid and that measured with the
product, on these conditions:
• The image is stitched based on the grid markers.
• The object has not moved during the examination.
• No pressure is applied on the stitching grid, causing it to bend.
WARNING:
If the patient leans against the stitching grid, the bending of the
grid will decrease the accuracy of length measurements.
WARNING:
The system cannot predict the impact of patient movement or of
inaccurate input data on the accuracy of a measurement done
on anatomical parts.
The user is responsible for observation of the movement of the
patient during the examination. Such movement influences the
accuracy of measurements when using the anatomical stitching.
Perform the quality control of stitched image as described in the
basic workflow and take into account vertical and horizontal
correction in stitching zones when performing measurements.
Related Links
Making measurements on page 63
Perform a quality control on page 38
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Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify
Agfa.
If, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorised
representative and to your national authority.
Manufacturer address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax [phone]
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Labels
Date of manufacture
Manufacturer
Medical device
Serial number
Production lot number
Unique device identifier, in text format
and in machine readable format
The most recent version of this docu-
ment is available on http://www.agfa-
healthcare.com/global/en/library/
index.jsp
Table 1: DX Full Leg Full Spine Stand (type 6001/100)
Label Meaning
Figure 4: Example of the type label
Type label
Maximum patient weight
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Table 2: DX FLFS Horizontal Overlay (type 6001/200), DR 600 FLFS
Horizontal Overlay (type 6001/220)
Label Meaning
Figure 5: Example of the type label
Type label
300
Maximum patient weight
Handle with care
Tube side
Top side according to pa-
tient orientation
Bottom side according to
patient orientation
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Cleaning and Disinfection
All appropriate policies and procedures should be followed to avoid
contamination of the user/staff, patients and other equipment. All existing
universal precautions should be extended to avoid coming into contact with
patient or close contact with patient or potential contaminations. The user is
responsible for selecting a disinfection procedure.
• If required, wipe the patient contact surfaces of the DX Full Leg Full Spine
Stand or of the FLFS Horizontal Overlay using disinfectants such as
ethanol (70%), to prevent the risk of infection.
• Do not spray the equipment directly with disinfectants or detergents.
• Wipe it with a cloth slightly damped with a neutral detergent. Do not use
solvents such as anhydrous or high solvency alcohols, thinner or benzine.
Doing so may damage the surface of the equipment.
• Take care that by using disinfectants, the skin of the user or of the patient
cannot be irritated.
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