AGFA DR 400 User manual

DR 400
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User Manual
3231E EN 20210708 1530

Contents
Legal Notice ..........................................................................7
Introduction to this Manual ................................................... 8
Scope of this Manual ..................................................9
About the safety notices in this document ................ 10
Disclaimer ................................................................11
Introduction to DR 400 ........................................................ 12
Intended Use ........................................................... 13
Intended User .......................................................... 14
Configuration .......................................................... 15
Applied Parts ............................................... 16
Options and Accessories ...........................................18
Operation Controls .................................................. 19
Radiographic table ...................................... 20
Radiographic wall stand .............................. 21
Control Panel of the X-Ray Tube Stand ......... 22
Tube head display ........................................ 23
NX Application on the NX Workstation .........24
Software Console .........................................25
DR Detector Switch ......................................26
X-ray generator mini console ........................27
Manual collimator ....................................... 29
Automatic collimator ................................... 30
Portable DR Detector ................................... 31
Emergency stop button ................................ 32
Emergency shutdown power switch ............. 33
Installation .............................................................. 34
HF-emission and immunity .......................... 34
Radiation Protection ................................................35
Monitoring of Personnel .............................. 36
Protected area and significant zones of occupancy
..........................................................................37
Labels ...................................................................... 42
Warning labels on the radiographic table ..... 44
Warning labels on the radiographic wall stand .
44
Type label .................................................... 45
DR Detector identification label ................... 46
Additional Labeling of the radiographic table ...
47
Additional Labeling of the radiographic wall stand
..........................................................................49
Labeling of the bucky ...................................50
Labeling of the Automatic Exposure Control (AEC)
..........................................................................52
Labeling of the DR Generator Sync Box ........53
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Cleaning and Disinfecting ........................................ 54
Cleaning ...................................................... 55
Disinfecting ................................................. 57
Disinfecting safety directions ....................... 58
Approved disinfectants ................................ 59
Maintenance ............................................................60
Maintenance of the radiographic table,
radiographic wall stand and X-Ray Tube Stand .
60
Safety Directions ..................................................................64
General Safety Directions .........................................65
Safety Directions for the X-Ray System .....................67
Safety Directions for the radiographic table ............. 69
Basic Workflow ....................................................................70
Starting the System ..................................................71
Automated workflow for warming-up of X-ray
tube ............................................................ 71
Performing an exposure using the DR Detector ........ 73
Step 1: retrieve the patient info .................... 74
Step 2: select the exposure ...........................75
Step 3: prepare the exposure ........................76
Step 4: check the exposure settings .............. 77
Step 5: execute the exposure ........................78
Step 6: perform a quality control ..................79
Performing an exposure using a CR cassette .............80
Step 1: retrieve the patient info .................... 81
Step 2: select the exposure ...........................82
Step 3: prepare the exposure ........................83
Step 4: check the exposure settings .............. 84
Step 5: execute the exposure ........................85
Step 6: repeat steps 2 to 5 for the next
subexposures ...............................................86
Step 7: digitize the image ............................. 87
Step 8: perform a quality control ..................88
X-Ray System Positioning .........................................89
Radiographic table exposures ...................... 90
Oblique Exposures ....................................... 91
Lateral Exposures ........................................ 92
Radiographic wall stand exposures .............. 93
Stopping the System ................................................ 94
Guidelines for pediatric applications ........................95
Guidelines for Pediatric Applications ........... 95
Software Console and Tube Head Display ............................ 97
Action buttons ......................................................... 98
Planned exposures ...................................................99
Image Preview Window ......................................... 100
Main screen of the Tube head display ..................... 101
Position parameters ................................... 102
X-ray tube stand tracks table height ............103
X-ray tube stand tracks wall stand height ... 104
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Collimator Parameters ............................... 106
X-ray modality status frame ....................................107
Ready For Exposure Status .........................108
Modality Position .......................................109
DR Detector Switch .................................... 110
Filter Status ................................................111
Grid Status .................................................112
Radiation status ......................................... 113
Unknown status ......................................... 114
Generator controls ................................................. 115
Radiographic working modes ..................... 116
Radiographic Parameters ........................... 118
Focal Spot Indicator ................................... 119
Automatic Exposure Control (AEC) ............120
X-Ray Tube Load ........................................ 123
DAP Value ..................................................124
Heat Units ..................................................125
X-ray modality controls .......................................... 126
System messages ....................................................127
Radiographic Table and X-Ray Tube Stand ......................... 129
Positioning the X-Ray Tube Stand ...........................132
Stop positions ............................................ 134
Collision indicator ......................................135
Positioning the radiographic table ......................... 136
Positioning the floating tabletop ................ 137
Adjusting height ........................................ 138
Positioning the Bucky ............................................ 139
Radiographic Table Accessories ..............................140
Mounting the patient hand grips ................ 141
Mounting the tabletop hand grips .............. 142
Collision protection ....................................143
Mattress .....................................................144
Lateral cassette holder ................................145
Compression belt ....................................... 146
Manual Collimator ................................................. 147
Dose Area Product Meter (DAP) ................. 147
Automatic Collimator .............................................149
Semi-automatic collimation mode ..............151
Manual collimation mode .......................... 152
Dose Area Product Meter (DAP) ................. 153
Effect of SID on patient dose .................................. 154
Radiographic wall stand .................................................... 155
Positioning the Radiographic Wall Stand ................157
Radiographic Wall Stand Accessories ..................... 159
Patient hand grips ......................................160
Mounting the overhead handle ...................161
Spacer ........................................................162
Wall stand fixation kit ................................ 163
Bucky ................................................................................ 164
Bucky configuration ...............................................166
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Rotating the bucky ................................................. 167
Loading of the bucky in the Radiographic Table ..... 168
Loading of the bucky in the Radiographic Wall Stand ...
169
Unloading of the bucky in the Radiographic Table ..170
Unloading of the bucky in the Radiographic Wall Stand
....................................................................................171
Automatic Cassette Size Sensing ............................ 172
Centering and collimating ......................................173
Bucky types ............................................................175
Cassette and detector formats ................................ 177
Standard cassette formats ...................................... 178
DR Detector formats and orientation ......................179
Orientation of DR 10s in the bucky .............180
Orientation of DR 14s in the bucky ............. 181
Orientation of DX-D 10C, DX-D 10G in the bucky
........................................................................183
Using DX-D 45C, DX-D 45G, XD 10, XD⁺10 only
outside the bucky .......................................184
Grids ......................................................................185
Anti-scatter grids ....................................... 186
Grid focal distance color indication ............ 187
Grid detection ............................................188
Storage box for DR Detector and grids ........189
Automatic Exposure Control (AEC) ........................190
X-Ray Generator Mini Console ........................................... 191
Starting and stopping the generator ....................... 192
X-ray tube start-up modes ...................................... 193
X-ray generator messages and warning signals ....... 194
X-ray generator errors ................................ 196
Error numbers ............................................197
Exposure parameters ............................................. 202
Problem solving .................................................................205
Restoring connection between generator and NX after
generator failure ....................................................206
Automatic collimation always too wide or too narrow ..
207
Empty Bucky Failure, Double Exposure Failure ...... 208
NX does not connect to the generator due to ID tablet ..
209
No table movement ................................................ 210
DR Detector is Exceeding the Maximum Working
Temperature .......................................................... 211
DR Detector must be Recalibrated .......................... 212
System does not start completely if collimator is in manual
mode ..................................................................... 213
Tube head display shows screen to check network
connection ............................................................. 214
Radiographic Parameter Limits .............................. 215
Product Information ...........................................................216
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Compatibility ......................................................... 217
Connectivity ...........................................................218
Compliance ............................................................219
General ......................................................220
Safety ........................................................ 220
Electromagnetic Compatibility ...................220
X-Ray Safety .............................................. 220
X-Ray Accuracy .......................................... 221
Environmental Compliance ........................221
Biocompatibility .........................................221
Usability .................................................... 221
Equipment Classification ....................................... 222
Patient data security .............................................. 223
Product Complaints ............................................... 224
Environmental protection ...................................... 225
System Documentation ..........................................226
Training .................................................................227
Technical Data ....................................................... 228
DR 400 Technical Data ...............................229
Generator Technical Data ...........................231
Radiographic Table and X-Ray Tube Stand
Technical Data ........................................... 233
Radiographic Wall Stand Technical Data ....236
X-Ray Tube Technical Data .........................238
Bucky Unit Technical Data ......................... 240
Automatic Exposure Control (AEC) Technical Data
........................................................................243
Manual Collimator Technical Data ............. 244
Automatic Collimator Technical Data ......... 245
Dose Area Product Meter (IBA DAP) Technical
Data ...........................................................246
Dose Area Product Meter (VacuTec DAP) Technical
Data ...........................................................247
Fixed DR Detector ......................................248
Portable DR Detector Technical Data ..........252
NX Workstation Technical Data ..................253
DR Generator Sync Box Technical Data ...... 254
Remarks for HF-emission and immunity ................255
Immunity to RF wireless communication
equipment ................................................. 260
Precautions on EMC ................................... 261
Cables, transducers and accessories ........... 262
Maintenance on EMC relevant parts ...........265
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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 400 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 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
DR 400 | Legal Notice | 7
3231E EN 20210708 1530

Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
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3231E EN 20210708 1530

Scope of this Manual
This User Manual describes the features of the DR 400 System, an integrated
X-Ray imaging system. It explains how the different components of the DR
400 System work together.
DR 400 | Introduction to this Manual | 9
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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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3231E EN 20210708 1530

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.
DR 400 | Introduction to this Manual | 11
3231E EN 20210708 1530

Introduction to DR 400
Topics:
•Intended Use
•Intended User
•Configuration
•Options and Accessories
•Operation Controls
•Installation
•Radiation Protection
•Labels
•Cleaning and Disinfecting
•Maintenance
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Intended Use
• The DR 400 system is a General Radiography X-ray imaging system used in
hospitals, clinics and medical practices by physicists, radiographers and
radiologists to make, process and view static X-ray radiographic images of
the skeleton (including skull, spinal column and extremities), chest,
abdomen and other body parts on adult or pediatric patients.
• Applications can be performed with the patient in the sitting, standing or
lying position.
• This device is not intended for mammography applications.
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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.
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Configuration
DR 400 is a configurable DR (Direct Radiography X-ray system) or CR
(Computed Radiography) X-ray system.
The complete DR 400 consists of the following components:
• Radiographic table with an integrated Fixed DR Detector or with a bucky.
In the bucky a DR Detector or a CR cassette can be inserted.
• Radiographic wall stand with an integrated Fixed DR Detector or with a
bucky. In the bucky a DR Detector or a CR cassette can be inserted.
• Bucky with integrated battery charger for DR 14s detecors (optional)
• X-ray tube stand mounted on the radiographic table
• X-ray generator integrated in the radiographic table
• X-ray generator mini console
• X-ray tube with manual or automatic collimator
• NX image processing software on the NX workstation
• DR Generator Sync Box (depending on the configuration)
• Automatic Exposure Control (AEC)
• Dose Area Product Meter (DAP, optional)
DR 400 also has a configuration without radiographic wall stand.
Depending on the configuration the following components are also available:
• Portable DR Detector
DR 400 can be used in combination with:
• DX-G
• DX-M
• CR 30-X (5175/2XX)
• CR 30-Xm
• CR 10-X
• CR 12-X
• CR 15-X
DR 400 has three main configurations:
1. DR configuration with X-ray exposure parameter control on the NX
workstation.
2. CR configuration with X-ray exposure parameter control on the NX
workstation.
3. Mixed DR and CR configuration with X-ray exposure parameter control on
the NX workstation.
X-ray parameters are controlled using the Software Console on the NX
workstation.
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The Software Console is available on the NX workstation, to synchronize the
X-ray exposure parameters between the NX application and the generator.
Other configurable features include:
• Tube head display with controls for X-ray exposure parameters
• Position tracking for keeping constand SID on table and wall stand
• Bucky with automatic cassette size sensing (ACSS) and automatic
collimator
236
45
1
1. NX workstation
2. X-ray tube stand mounted on the radiographic table
3. X-ray tube with collimator and tube head display
4. Portable DR Detector
5. Radiographic table with integrated generator
6. Radiographic wall stand
Figure 1: DR 400 configuration for DR
Topics:
•Applied Parts
Applied Parts
Applied Parts refer to parts of the medical electrical equipment that in normal
use necessarily comes into physical contact with the patient for the equipment
to perform its function. This system includes the following Applied Parts:
Topics:
•Radiographic table
•Radiographic wall stand
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3231E EN 20210708 1530

•DR Detector
Radiographic table
• Table top of the radiographic table
• Patient hand grips (optional)
• Lateral cassette holder (optional)
• Mattress (optional)
• Compression belt (optional)
Radiographic wall stand
• Front panel of the radiographic wall stand
• Overhead arm support (optional)
• Patient hand grips (optional)
DR Detector
• DR Detector
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3231E EN 20210708 1530

Options and Accessories
The system is delivered with 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.
For information on options and accessories of the DR Detector, refer to the
user manual of the DR Detector.
Related Links
Radiographic Table Accessories on page 140
Radiographic Wall Stand Accessories on page 159
18 | DR 400 | Introduction to DR 400
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Operation Controls
Topics:
•Radiographic table
•Radiographic wall stand
•Control Panel of the X-Ray Tube Stand
•Tube head display
•NX Application on the NX Workstation
•Software Console
•DR Detector Switch
•X-ray generator mini console
•Manual collimator
•Automatic collimator
•Portable DR Detector
•Emergency stop button
•Emergency shutdown power switch
DR 400 | Introduction to DR 400 | 19
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Radiographic table
The radiographic table is used for positioning of the patient lying or sitting
over the detector or the cassette in the bucky for exposure.
The radiographic table supports the patient and the detector or the cassette
for free exposure.
Figure 2: Radiographic table
Related Links
Radiographic Table and X-Ray Tube Stand on page 129
20 | DR 400 | Introduction to DR 400
3231E EN 20210708 1530