AGFA 5523/100 User manual

Bucky
5523/100 5523/110 5523/115
5523/120 5523/125 5523/200
5523/210 5523/215 5523/220
5523/225 5523/250 5523/260
5523/265 5523/270 5523/275
5523/300 5523/310 5523/320
User Manual
3253F EN 20210312 1125

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 .......................................................................... 9
Intended Use ............................................................10
Intended User .......................................................... 10
Installation .............................................................. 10
HF-emission and immunity .......................... 10
Labels ...................................................................... 11
Labeling of the bucky ................................... 11
Cleaning and Disinfecting ........................................ 13
Cleaning ...................................................... 14
Disinfecting ................................................. 15
Disinfecting safety directions ........................16
Approved disinfectants .................................17
Environmental protection ........................................ 18
Safety Directions ..................................................................19
General Safety Directions .........................................19
Bucky .................................................................................. 20
Bucky configuration ................................................ 22
Rotating the bucky ...................................................23
Loading of the bucky in the Radiographic Table ....... 24
Loading of the bucky in the Radiographic Wall Stand ...
25
Unloading of the bucky in the Radiographic Table ... 26
Unloading of the bucky in the Radiographic Wall Stand
......................................................................................27
Automatic Cassette Size Sensing .............................. 28
Centering and collimating ........................................29
Bucky types ..............................................................31
Cassette and detector formats .................................. 33
Standard cassette formats ........................................ 34
DR Detector formats and orientation ....................... 35
Orientation of DR 10s in the bucky ...............36
Orientation of DR 14s in the bucky ...............37
Orientation of DX-D 10C, DX-D 10G in the bucky
..........................................................................39
Using DX-D 45C, DX-D 45G only outside the bucky
..........................................................................40
Grids ........................................................................41
Anti-scatter grids ......................................... 42
Grid focal distance color indication ..............43
Grid detection ..............................................44
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3253F EN 20210312 1125

Product Information ............................................................ 45
Compatibility ...........................................................46
Compliance ............................................................. 46
General ........................................................47
Safety .......................................................... 47
Electromagnetic Compatibility ..................... 47
Environmental Compliance ..........................47
Equipment Classification ......................................... 48
Product Complaints ................................................. 49
Training ...................................................................50
Technical Data ......................................................... 51
Bucky Unit Technical Data ........................... 51
Remarks for HF-emission and immunity ..................54
Immunity to RF wireless communication
equipment ................................................... 59
Precautions on EMC .....................................60
Maintenance on EMC relevant parts .............61
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3253F EN 20210312 1125

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. All 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
4 | Bucky | Legal Notice
3253F EN 20210312 1125

Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
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3253F EN 20210312 1125

Scope of this Manual
This User Manual describes the features of the listed bucky types, further
referred to as the bucky. The bucky is part of a DR system.
• BT-Cassette-T-001
• BT-Cassette-T-GSS-001
• BT-Cassette-T-ACSS-001
• BT-Cassette-WS-L-001
• BT-Cassette-WS-GSS-L-001
• BT-Cassette-WS-ACSS-L-001
• BT-Cassette-WS-R-001
• BT-Cassette-WS-GSS-R-001
• BT-Cassette-WS-ACSS-R-001
• BT-Fixed-T-001
• BT-Fixed-WS-L-001
• BT-Fixed-WS-R-001
• CASS BUCKY TABLE W/O ACSS INCL DET CHARG
• CASS BUCKY WS LL W/O ACSS INCL DET CHARG
• CASS BUCKY WS RL W/O ACSS INCL DET CHARG
• CASS BUCKY TABLE ACSS INCL DET CHARG
• CASS BUCKY WS LL ACSS INCL DET CHARG
• CASS BUCKY WS RL ACSS INCL DET CHARG
This User Manual also describes the supported anti-scatter grids.
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3253F EN 20210312 1125

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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3253F EN 20210312 1125

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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3253F EN 20210312 1125

Introduction
Topics:
•Intended Use
•Intended User
•Installation
•Labels
•Cleaning and Disinfecting
•Environmental protection
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3253F EN 20210312 1125

Intended Use
The bucky is a component of a General Radiography X-ray imaging system
used in hospitals, clinics and medical practices by physicists, radiographers
and radiologists to hold and position the X-ray cassette (CR), the DR detector
and optionally to hold the AEC and grid.
The device is not intended for mammography applications.
Intended User
This manual has been written for trained users of Agfa products and trained
diagnostic X–Ray clinical personnel who have received proper training.
Users are those persons who actually handle the equipment and those who
have 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.
Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
HF-emission and immunity
The HF-emission and immunity can be influenced by connected data cables
depending on length and the manner of installation.
A specific installation environment may require special measures to put the
system into operation according to the remarks for HF-emission and
immunity.
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Labels
Mark Meaning
This mark shows compliance of the equipment with Regulation
2017/745 (for European Union).
Date of manufacture
Manufacturer
Medical device
Serial number
Unique device identifier, in text format and in machine readable
format
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
Further labels are listed and explained in the relevant modules of the System
Documentation.
Labeling of the bucky
Figure 1: (Sample of subtype
5523/120)
The type label is located on the rear cov-
er of the bucky or on the bucky drawer
below the rotating platform.
The type label information for each
bucky model is available in the technical
data.
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3253F EN 20210312 1125

Figure 2: (Sample of subtype
5523/125)
Class II equipment.
Pinch Points.
The label is positioned on the lateral
cover of the bucky or on the rotating
platform.
10kg
Maximum load capacity is 10 kg on the
bucky drawer when it is pulled out. Do
not lean or sit on the bucky.
The label is positioned on the lateral
cover of the bucky or on the rotating
platform.
Read the instructions in the user man-
ual.
The label is positioned on the lateral
cover of the bucky or on the rotating
platform.
Compliance with China RoHS SJ/
T11364-2006. Indication of the Environ-
ment Friendly Use Period (EFUP) as the
period (years) during which the hazard-
ous substances do not leak or mutate
under normal use.
The label is located on the rear cover of
the bucky or on the bucky drawer below
the rotating platform.
Related Links
Bucky Unit Technical Data on page 51
12 | Bucky | Introduction
3253F EN 20210312 1125

Cleaning and Disinfecting
All appropriate policies and procedures should be followed to avoid
contamination of the staff, patients and equipment. All existing universal
precautions should be extended to avoid potential contaminations and to
avoid patients coming into (close) contact with the device. The user is
responsible for selecting a disinfection procedure.
Topics:
•Cleaning
•Disinfecting
•Disinfecting safety directions
•Approved disinfectants
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3253F EN 20210312 1125

Cleaning
To clean the exterior of the equipment:
1. Stop the system
WARNING:
When the equipment is going to be cleaned, be sure to turn
off the main power of the system. Never use anhydrous or
high solvency alcohols, benzine, thinner or any other
flammable cleaning agent. Otherwise, it may result in fire or
electric shock.
2. Wipe the exterior of the system with a cloth slightly moistened with a
neutral detergent.
CAUTION:
Make sure no liquid gets in the device.
CAUTION:
Clean the equipment with only a little moisture. Do not
spray disinfectants or detergents directly on the equipment.
Do not pour liquid directly on the equipment.
CAUTION:
Do not use solvents such as anhydrous or high solvency
alcohols, thinner or benzine. Do not use any corrosive,
dissolving or abrasive cleaning or polishing detergents.
Doing so may damage the surface of the equipment. Using
unsuitable cleaning agents or methods can damage the
property when surface becomes dull and brittle (e.g. by
using alcohol-containing agents).
Note: Do not open the equipment for cleaning. No
components inside the device require cleaning by the user.
3. Start up the system.
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3253F EN 20210312 1125

Disinfecting
WARNING:
To disinfect the device, use only disinfectants and disinfection
methods that are approved by Agfa and that correspond to the
national regulation and guidelines as well as explosion
protection.
If you plan to use other disinfectants, approval of Agfa is needed before use, as
most disinfectants can damage the device. UV disinfection is also not allowed.
Perform the procedure following the instructions for use, the disposal
instructions and the safety instructions of the selected disinfectants and tools
and of the hospital.
Items contaminated with blood or body fluids, which may contain blood-
borne pathogens, should be cleaned and then receive intermediate level
disinfection with a product having an EPA-registered claim for activity against
hepatitis B.
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3253F EN 20210312 1125

Disinfecting safety directions
WARNING:
Using a disinfectant that can form an explosive or flammable
gas mixtures is hazard to life and health because of explosion
risk. Switch the equipment off before disinfecting. Allow the gas
mixture to evaporate before switching the x-ray system back on.
CAUTION:
Using unsuitable disinfectants can cause discoloration and
damage of the surface of the equipment. If a functional
degradation or malfunctioning of the product is noticed due to
disinfection, contact the medical device manufacturer.
To disinfect the device:
• Do not use any corrosive, soluble or gaseous disinfectants.
• Consult the manufacturer’s Material Safety Data Sheets (MSDS) and
recommendations on the product label for additional information prior to
use.
• Use of spray disinfection can cause malfunctions due to ingress of the
disinfectant into the equipment. Disinfect all parts of the unit, including
the accessories and connection cables by just wiping them. Switch off the
system and cover the cooled system carefully before performing a room
disinfection using nebuliser.
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3253F EN 20210312 1125

Approved disinfectants
Refer to the Agfa website for specifications on the disinfectants that have been
found compatible with the cover material of the device and can be used on the
outer surface of the device.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138
Bucky | Introduction | 17
3253F EN 20210312 1125

Environmental protection
Figure 3: WEEE symbol
WEEE end user notice
The directive on Waste Electrical and Electronic Equipment (WEEE) aims to
prevent the generation of electric and electronic waste and to promote the
reuse, recycling and other forms of recovery. It therefore requires the
collection of WEEE, recovery and reuse or recycling.
Due to the implementation into national law, specific requirements can be
different within the European Member States. The WEEE symbol on the
products, and/or accompanying documents means that used electrical and
electronic products should not be treated as, or mixed with general household
waste. For more detailed information about take-back and recycling of this
product please contact your local service organization and/or dealer. The
recycling of materials will help to conserve natural resources.
c2-caution: By ensuring this product is disposed of correctly, you will help
prevent potential negative consequences for the environment and human
health, which could otherwise be caused by inappropriate waste handling of
this product.
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3253F EN 20210312 1125

Safety Directions
General Safety Directions
WARNING:
Safety is only guaranteed when an Agfa certified field service
engineer has installed the product.
WARNING:
The product must only be installed using released components
and in released configurations.
CAUTION:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.
CAUTION:
All Agfa medical products must be used by trained and qualified
personnel.
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3253F EN 20210312 1125

Bucky
The bucky is installed in the radiographic table and in the radiographic wall
stand.
The bucky clamps the cassette or detector during exposure and centers them
relative to the Automatic Exposure Control (AEC) and the grid.
The bucky supports cassettes in standard formats as well as DR Detectors with
cassette size format.
The bucky functionalities can be configured according the customer needs.
1
43
6
5
7
2
1. Bucky drawer
2. Button to release the brake
3. Bucky drawer handle
4. Carrier for the cassette or detector
5. Knob for rotating the cassette or detector
6. Clamps
7. Side clamps
Figure 4: Bucky
1
23 4 5
1. Tabletop
2. Removable grid
3. Automatic exposure control (AEC)
4. Carrier for cassette or detector
5. Bucky drawer with rotation mechanism
Figure 5: Bucky front view
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