AGFA 5400/516 User manual

DR Generator Sync Box, DR
Retrofit Solution
5400/516
5400/526
User Manual
0319D EN 20191031 1011

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope of this Manual ..................................................6
Warnings, Cautions, Instructions and Notes ...............7
Disclaimer ................................................................. 8
Introduction .......................................................................... 9
Intended Use ............................................................10
Intended User .......................................................... 11
Configuration .......................................................... 12
Equipment Classification ..........................................14
Options and Accessories ...........................................15
Operation Controls .................................................. 16
Exposure button ...........................................17
DR Software Console ................................... 18
DR Detector Switch ......................................19
System Documentation ............................................20
Training ................................................................... 21
Product Complaints ................................................. 22
Compatibility ...........................................................23
Compliance ..............................................................24
General ........................................................25
Safety .......................................................... 25
Electromagnetic Compatibility .....................25
Environmental Compliance ..........................25
Connectivity ............................................................ 26
Connectivity requirements ...........................26
Installation .............................................................. 27
Messages ................................................................. 28
Labels ...................................................................... 29
Consulting the About box .............................30
Cleaning and Disinfecting ........................................ 31
Patient data security ................................................ 32
Requirements on the operating environment ...
32
Maintenance ............................................................34
Environmental protection ........................................ 35
Safety Directions ......................................................36
Disconnecting the DR Generator Sync Box from
the mains power .......................................... 37
Getting started .....................................................................38
Starting ................................................................... 39
Basic Workflow ........................................................39
Step 1: retrieve the patient info ....................40
Step 2: select the exposure ........................... 41
Step 3: prepare the exposure ........................42
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Step 4: check the exposure settings .............. 43
Step 5: execute the exposure ........................44
Step 6: perform a quality control ..................45
Stopping .................................................................. 45
Problem solving ...................................................................46
NX receives black or underexposed DR image due to
repeatedly pushing the exposure button ...................47
NX receives black DR image when X-ray system not ready
for exposure .............................................................48
Wrong modality position selected ............................ 49
Exposure blocked after switching to CR ................... 50
Panel status remains in error ....................................51
Technical Data .....................................................................52
DR Retrofit Solution Technical Data .........................53
DR Generator Sync Technical Data ...........................54
Fixed DR Detector Technical Data ............................ 55
Remarks for HF-emission and immunity ..............................57
Immunity to RF wireless communication equipment ....
62
Precautions on EMC .................................................63
Cables, transducers and accessories ......................... 64
Maintenance on EMC relevant parts .........................65
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Legal Notice
0413
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. DR Retrofit Solution and DR Generator Sync box are trademarks
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 2019 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
•Warnings, Cautions, Instructions and Notes
•Disclaimer
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Scope of this Manual
This manual contains information for safe and effective operation of the DR
Retrofit Solution, further referred to as the system and the DR Generator Sync
Box, further referred to as the device.
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Warnings, Cautions, Instructions and Notes
The following samples show how warnings, cautions, instructions and notes
appear in this document. The text explains their intended use.
Warning: Warnings are directions which, if they are not
followed, can cause fatal or serious injuries to a user,
engineer, patient or any other person or can lead to a
mistreatment.
Caution: Cautions are directions which, if they are not followed,
can cause damage to the equipment described in this manual or
any other equipment or goods and can cause environmental
pollution.
Instruction: This sign is typically used in combination with the
warning sign when providing a specific instruction. If it is followed
exactly, it should avoid the subject of the warning.
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 to sale
by or on the order of a physician.
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Introduction
Topics:
•Intended Use
•Intended User
•Configuration
•Equipment Classification
•Options and Accessories
•Operation Controls
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Messages
•Labels
•Cleaning and Disinfecting
•Patient data security
•Maintenance
•Environmental protection
•Safety Directions
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Intended Use
The DR Retrofit Solution is indicated for use in general projection
radiographic applications to capture for display diagnostic quality
radiographic images of human anatomy for adult, pediatric and neonatal
examinations. The DR Retrofit Solution converts the screen-film or CR system
into a DR system.
The DR Retrofit Solution is not indicated for use in mammography.
The DR Generator Sync Box is indicated for use as a component of the DR
Retrofit Solution. The DR Generator Sync Box is making the connection
between the DR detector, the NX workstation and the X-ray generator.
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Intended User
This manual is written for trained users of Agfa products. 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 Retrofit Solution consists of the following components:
• DR Detector
• NX workstation
• DR Generator Sync Box
The DR Retrofit Solution supports two levels of integration with the X-ray
system.
1. Integration of the exposure signal.
• The exposure button of the X-ray system is removed or disabled and a
new exposure button is connected to the DR Generator Sync Box.
2. Integration of X-ray exposure parameters.
• The exposure button of the X-ray system is replaced by an exposure
button connected to the DR Generator Sync Box.
• X-ray parameters can be controlled using either the Software Console
on the NX workstation or the X-ray generator console of the X-ray
system, depending on the configuration.
The DR Generator Sync Box synchronizes the exposure signal between the DR
detector, the NX workstation and the generator.
Maximum three exposure buttons can be connected to the DR Generator Sync
Box. An exposure button can be a hand switch or a foot switch.
The Software Console is available on the NX workstation and synchronizes the
X-ray exposure parameters between the NX workstation and the generator.
Note: Integration of X-ray exposure parameters is only supported
on specific types of X-ray systems. Contact your local service
representative for more information about the supported X-ray
systems.
1
2
3
4
5
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1. X-ray system
2. NX workstation with NX application and DR Software Console or DR
Detector Switch
3. DR Detector
4. Replacement exposure button
5. DR Generator Sync Box
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Equipment Classification
This device is classified as following:
Table 1: Equipment classification
Class I equipment Equipment in which protection against electric
shock does not relay on basic insulation only, but
includes a power supply cord with protective earth
conductor. For earth reliability always plug the
main power cord into an earthed mains power out-
let.
Type B equipment Not classified.
The patient does not get in contact with any part of
the equipment.
Water ingress This device does not have protection against in-
gress of water.
Cleaning See section on cleaning and disinfecting.
Disinfection See section on cleaning and disinfecting.
Flammable anesthetics This device is not suitable for use in the presence of
a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
Operation Continuous operation.
Related Links
Cleaning and Disinfecting on page 31
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Options and Accessories
The delivery contains a set of labels. When using multiple DR Detectors, on
the labels a nickname is written to identify the DR Detector. An identical label
is attached to the bucky of the X-ray system to identify the dedicated
workspace of each DR Detector.
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Operation Controls
The main operation controls are:
• Power switch
• Exposure button
• DR Detector Switch on the NX workstation
Warning: The exposure button of the original system should
be disabled.
Topics:
•Exposure button
•DR Software Console
•DR Detector Switch
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Exposure button
Preparing for exposure
Press the exposure button down to the first pressure point and hold it for
approximately 0.5 s to 2 s.
The X-ray tube is prepared for performing an exposure.
Starting the exposure
Before starting the exposure:
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check the Ready for Exposure status.
Press the exposure button down fully and keep it pressed until the exposure
has ended.
The radiation indicator on the control console lights up and a signal sounds to
indicate the exposure.
Note: Letting the exposure button go ends the exposure
immediately and the exposure can be underexposed.
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DR Software Console
The DR Software Console is available to support X-ray exposure parameter
control on the NX workstation. It is displayed on the NX workstation next to
the NX application.
The DR Software Console is used to control the X-ray exposure settings.
The DR Software Console contains the DR Detector Switch.
Figure 1: DR Software Console
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DR Detector Switch
The DR Detector Switch is available in the title bar of the NX application or in
the device status frame of the DR Software Console.
The DR Detector Switch shows which DR Detector is active and shows its
status. The DR Detector Switch can be used to activate another DR Detector.
Figure 2: DR Detector Switch
Figure 3: DR Detector Switch in the title bar of the NX application
DR Detector Status
Battery status icon
Meaning Full Medium Low Empty
Connection status icon (wifi/
wired)
Meaning Good Low Bad Wired DR Detector
Panel status icon
(blinking) (blinking)
Meaning Ready Initializing exposure Starting up Error Sleep
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System Documentation
The DR Retrofit Solution user documentation consists of
• DR Generator Sync Box, DR Retrofit Solution User Documentation CD
(digital media)
• NX User Documentation CD (digital media)
• User documentation for the supported DR Detectors
The DR Generator Sync Box, DR Retrofit Solution Documentation CD
contains:
• DR Generator Sync Box, DR Retrofit Solution User Manual (this
document), document 0319
• DR Software Console User Manual, document 0289
• DR Detector Calibration Key User manual, document 0134
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