AGFA DR 600 User manual

DR 600
5530/100
User Manual
3261K EN 20210708 0808

Contents
Legal Notice ..........................................................................9
Introduction to this Manual ................................................. 10
Scope of this Manual ................................................11
About the safety notices in this document ................ 12
Disclaimer ............................................................... 13
Introduction .........................................................................14
Intended Use ........................................................... 15
Intended User .......................................................... 16
Configuration .......................................................... 17
Applied Parts ............................................... 19
Options and Accessories ...........................................20
Operation Controls .................................................. 21
Radiographic table ...................................... 22
Radiographic wall stand .............................. 23
Control Panel of the X-Ray Tube Head Unit ....
24
Remote Control for the X-Ray Tube Head Unit ..
25
Tube head display ........................................ 27
MUSICA Acquisition Workstation (NX) ........ 28
Software Console .........................................29
Extra monitor in the examination room ....... 30
DR Detector Switch ......................................31
Automatic positioning button .......................32
X-ray generator mini console (Spellman) ..... 33
X-ray generator mini console (EMD) ............ 34
Exposure button .......................................... 35
Automatic collimator ................................... 36
Collimator camera ....................................... 37
Portable DR detector ....................................39
Emergency stop button ................................ 40
Emergency shutdown power switch ............. 42
Power off behaviour .....................................43
Installation .............................................................. 44
HF-emission and immunity ..........................44
Radiation Protection ................................................45
Monitoring of Personnel .............................. 46
Protected area and significant zones of occupancy
..........................................................................47
Skin dose levels according to IEC 60601-2-54 ..
54
Ongoing quality control in digital radiography .
55
Labels ...................................................................... 56
Warning labels on the radiographic table ..... 58
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Warning labels on the radiographic wall stand .
58
Type label .................................................... 59
DR Detector identification label ................... 60
Additional Labeling of the Tube Head Unit ... 61
Additional Labeling of the Radiographic Table .
62
Additional Labeling of the Radiographic Wall
Stand ...........................................................63
Labeling of the bucky ...................................64
Labeling of the Automatic Exposure Control (AEC)
..........................................................................66
Labeling of the DR Generator Sync Box ........ 67
Labeling of the X-ray generator (Spellman) ....
68
Labeling of the X-ray generator (EMD) .........70
Labeling of the Remote Control ....................71
Labeling of components with earthquake
resistance .....................................................72
About the software ...................................... 73
Cleaning and Disinfecting ........................................ 74
Cleaning ...................................................... 75
Disinfecting ................................................. 77
Disinfecting safety directions ....................... 78
Approved disinfectants ................................ 79
Maintenance ............................................................80
Maintenance of the radiographic table,
radiographic wall stand and X-Ray Tube Head Unit
..........................................................................80
Safety Directions ..................................................................84
General Safety Directions .........................................85
Safety Directions for the X-Ray System .....................87
Safety Directions for the radiographic table ............. 89
Safety Directions for the Ceiling Suspension ............ 90
Basic Workflow ....................................................................91
Starting the System ................................................. 92
Automated workflow for warming-up of X-ray
tube ............................................................ 92
Performing an exposure using the DR Detector ........ 94
Step 1: retrieve the patient info ....................95
Step 2: select the exposure ...........................96
Step 3: Prepare the exposure ........................97
Step 4: Check the exposure settings ............. 98
Step 5: execute the exposure ........................99
Step 6: perform a quality control ................100
Performing a digital tomosynthesis examination .... 101
Step 1: prepare the examination ................ 102
Step 2: position the X-ray system and the patient
........................................................................105
Step 3: check the exposure settings ............ 106
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Step 4: execute the digital tomosynthesis exposure
sequence ....................................................107
Step 5: perform a quality control ................ 110
Performing an exposure using a CR cassette ........... 111
Step 1: retrieve the patient info .................. 112
Step 2: select the exposure ......................... 113
Step 3: prepare the exposure ...................... 114
Step 4: check the exposure settings ............ 115
Step 5: execute the exposure ...................... 116
Step 6: repeat steps 2 to 5 for the next
subexposures ............................................. 117
Step 7: digitize the image ........................... 118
Step 8: perform a quality control ................ 119
Performing a Full Leg Full Spine examination ........ 120
Stopping the System .............................................. 121
Guidelines for pediatric applications ...................... 122
Guidelines for Pediatric Applications ..........122
Software Console and Tube Head Display .......................... 124
Action buttons ....................................................... 126
Planned exposures ................................................. 127
Live camera image on the tube head display ...........128
Previewing the position of the collimation area
and the AEC fields ......................................129
Prerequisites for previewing collimation and AEC
fields ..........................................................130
Non-perpendicular angles .......................... 131
Image Preview Window ......................................... 132
Main screen of the Tube head display ..................... 133
Device Status Frame ...............................................134
Ready For Exposure Status .........................135
Modality Position .......................................136
DR Detector Switch ....................................137
Filter Status ............................................... 138
Grid Status .................................................139
Radiation status ......................................... 140
Unknown status ......................................... 141
Generator controls ................................................. 142
One point, two point and three point working
modes ........................................................143
Radiographic Parameters ........................... 145
Focal Spot Indicator ................................... 146
Automatic Exposure Control (AEC) ............ 147
X-Ray Tube Load ........................................ 152
DAP Value ..................................................153
Heat Units ..................................................154
DR detector and X-ray tube head alignment ........... 155
X-ray modality controls .......................................... 157
Positioning controls ............................................... 158
Positioning screen of the tube head display ....
159
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Actual and target position parameters ........ 160
Collimator Parameters ................................161
Automatic positions ................................... 162
Tracking the radiographic table ..................167
Tracking the radiographic wall stand ......... 169
Automatic centering ...................................171
Controls for digital tomosynthesis .......................... 173
Radiographic Parameters for digital tomosynthesis
........................................................................ 174
Position parameters for digital tomosynthesis ..
175
Reconstruction parameters .........................176
Adjusting the reconstruction settings for digital
tomosynthesis ............................................177
System messages ....................................................178
Ceiling Suspension .............................................................180
Control Panel of the Tube Head Unit ...................... 181
Positioning the X-Ray Tube .....................................182
Stop positions ............................................ 184
Collision indicator ......................................185
Positioning the X-Ray Tube using the Remote Control ..
186
Automatic Collimator .............................................189
Semi-automatic collimation mode ..............191
Manual collimation mode .......................... 192
Collimation area for free exposures ............ 193
Dose Area Product Meter (DAP) ................. 194
Effect of SID on patient dose .................................. 195
Radiographic Table ............................................................ 196
Positioning the Radiographic Table ........................ 197
Positioning the floating tabletop ................ 198
Adjusting height .........................................199
Collision protection ............................................... 200
Positioning the bucky .............................................201
Radiographic Table Accessories ............................. 202
Mounting the patient hand grips ................203
Mounting the tabletop hand grips .............. 204
Foot pedals at the rear side ........................ 205
Mattress .....................................................206
Lateral cassette holder ............................... 207
Compression belt ....................................... 208
Radiographic Wall Stand ................................................... 209
Positioning the Radiographic Wall Stand ................211
Radiographic Wall Stand Accessories ..................... 213
Patient hand grips ...................................... 214
Mounting the lateral arm rest .....................215
Spacer ........................................................216
Wall stand fixation kit ................................ 217
Bucky .................................................................................218
Bucky configuration .............................................. 220
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Rotating the bucky .................................................221
Loading of the bucky in the Radiographic Table ..... 222
Loading of the bucky in the Radiographic Wall Stand ...
223
Unloading of the bucky in the Radiographic Table . 224
Unloading of the bucky in the Radiographic Wall Stand
....................................................................................225
Opening the bucky drawer configured with an earthquake
kit ..........................................................................226
Automatic Cassette Size Sensing ............................ 227
Bucky types ........................................................... 228
Cassette and detector formats ................................ 230
Standard cassette formats ...................................... 231
DR Detector formats and orientation ..................... 232
Orientation of DR 10s in the bucky .............233
Orientation of DR 14s in the bucky .............234
Orientation of DX-D 10C, DX-D 10G in the bucky
........................................................................236
Using DX-D 45C, DX-D 45G, XD 10, XD⁺10 only
outside the bucky .......................................237
Grids ..................................................................... 238
Anti-scatter grids ....................................... 239
Grid focal distance color indication ............240
Grid detection ............................................ 241
Storage box for DR Detector and grids ........242
Changing the grid configured with an earthquake
kit ..............................................................243
Automatic Exposure Control (AEC) ........................244
X-Ray Generator Mini Console ........................................... 245
Starting and stopping the generator .......................246
X-ray tube start-up modes ...................................... 247
X-ray generator messages and warning signals (Spellman)
....................................................................................248
X-ray generator messages and warning signals (EMD) .
249
Exposure parameters ............................................. 250
Radiographic Parameter Limits ..................252
Exposure termination ............................................ 254
Problem solving .................................................................255
Restoring connection between generator and NX after
generator failure ....................................................256
Automatic collimation always too wide or too narrow ..
257
NX does not connect to the generator due to ID tablet ..
258
No table movement ................................................259
No movement when using remote control .............. 260
DR Detector is Exceeding the Maximum Working
Temperature .......................................................... 261
DR Detector must be Recalibrated ..........................262
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Tube head display shows screen to check network
connection .............................................................263
Radiographic Parameter Limits ..............................264
Product Information .......................................................... 265
Compatibility .........................................................266
Connectivity .......................................................... 267
Compliance ........................................................... 268
General ......................................................269
Safety ........................................................ 269
Electromagnetic Compatibility ...................269
X-Ray Safety .............................................. 270
X-Ray Accuracy .......................................... 270
Environmental Compliance ........................270
Biocompatibility ........................................ 270
Usability .................................................... 270
Earthquake resistance ................................270
Equipment Classification ....................................... 271
Patient data security .............................................. 272
Requirements on the operating environment ...
272
Product Complaints ................................................274
Environmental protection ...................................... 275
System Documentation .......................................... 277
Installing the Online Help .......................... 277
Training .................................................................279
Technical Data ....................................................... 280
DR 600 Technical Data ...............................281
Generator Technical Data (Spellman) ........ 283
Generator Technical Data (EMD) ............... 284
Radiographic Table Technical Data ............ 285
Wall Stand Technical Data ......................... 286
Ceiling Suspension Technical Data .............288
X-Ray Tube Technical Data .........................289
Bucky Unit Technical Data ......................... 291
Automatic Exposure Control (AEC) Technical Data
........................................................................293
Automatic collimator technical data ...........294
Dose Area Product Meter (IBA DAP) Technical
Data ...........................................................295
Dose Area Product Meter (VacuTec DAP) Technical
Data ...........................................................296
Fixed DR Detector ......................................297
Portable DR Detector Technical Data ..........301
NX Workstation Technical Data ..................302
DR Generator Sync Box Technical Data ...... 303
Remarks for HF-emission and immunity ................304
Immunity to RF wireless communication
equipment ................................................. 309
Precautions on EMC ................................... 310
Cables, transducers and accessories ........... 311
DR 600 | Contents | vii
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Maintenance on EMC relevant parts ........... 315
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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 600 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
DR 600 | Legal Notice | 9
3261K EN 20210708 0808

Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
10 | DR 600 | Introduction to this Manual
3261K EN 20210708 0808

Scope of this Manual
This User Manual describes the features of the DR 600 System, an integrated
X-Ray imaging system. It explains how the different components of the DR
600 System work together.
DR 600 | Introduction to this Manual | 11
3261K EN 20210708 0808

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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3261K EN 20210708 0808

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.
DR 600 | Introduction to this Manual | 13
3261K EN 20210708 0808

Introduction
Topics:
•Intended Use
•Intended User
•Configuration
•Options and Accessories
•Operation Controls
•Installation
•Radiation Protection
•Labels
•Cleaning and Disinfecting
•Maintenance
14 | DR 600 | Introduction
3261K EN 20210708 0808

Intended Use
The DR 600 system is a General Radiography X-ray imaging system used in
hospitals, clinics and medical practices by radiographers, radiologists and
physicists 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 adults and pediatric patients.
In addition, the system provides the Agfa tomosynthesis option, which is
intended to acquire tomographic slices of human anatomy and to be used with
Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize
tomographic slices from a single tomographic sweep.
Applications can be performed with the patient in sitting, standing or lying
position.
The system is not intended for use in Mammography applications.
DR 600 | Introduction | 15
3261K EN 20210708 0808

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.
16 | DR 600 | Introduction
3261K EN 20210708 0808

Configuration
DR 600 is a configurable DR (Direct Radiography X-ray system) and/or CR
(Computed Radiography) X-ray system.
DR 600 has configurations for DR, for CR and for mixed use of DR and CR.
DR 600 supports following applications:
• General radiography, including pediatrics
• Full leg full spine radiography
The complete DR 600 consists of the following components:
• Ceiling suspension with X-ray tube, collimator and tube head display
• Radiographic table with an integrated DX-D 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 DX-D 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 generator
• X-ray generator mini console
• X-ray tube with collimator
• NX workstation
• DR Generator Sync
• Automatic Exposure Control (AEC)
• Dose Area Product Meter (DAP, optional)
• Remote control (optional)
• Collimator camera ( Smart XR upgrade mounting kit, optional)
Limited DR 600 configurations can consist of a ceiling suspension with only a
wall stand or only a radiographic table.
X-ray parameters are controlled using the Software Console on the NX
workstation.
The Software Console is available on the NX workstation, to synchronize the
X-ray exposure parameters between the NX application and the generator.
Depending on the configuration the following components are also available:
• Portable DR Detector
DR 600 can be used in combination with:
• DX-G
• DX-M
• CR 30-X (5175/2XX)
• CR 30-Xm
• CR 10-X
DR 600 | Introduction | 17
3261K EN 20210708 0808

• CR 12-X
• CR 15-X
DR 600 includes following types of ceiling suspension and wall stand:
• Standard ceiling suspension or ceiling suspension with reduced ceiling
height
• Motorized wall stand (type 5522/600)
This configuration supports following functionality:
• automatic positioning
• automatic collimation
• auto-tracking functionality
• remote control (optional)
• DR Full Leg Full Spine application (optional)
• Digital tomosynthesis (optional)
Other configurable features include:
• Tube head display with controls for X-ray exposure and positioning
parameters
• Position tracking for keeping constant SID on table and wall stand
2 3 7641 5
1. NX workstation
2. Ceiling suspension
3. X-ray tube with collimator
4. Radiographic table
5. X-ray generator
6. DR Detector
7. Radiographic wall stand
Figure 1: DR 600 configuration for DR
18 | DR 600 | Introduction
3261K EN 20210708 0808

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
•DR Detector
Radiographic table
• Tabletop of the Radiographic table
• Patient hand grips (optional)
• Lateral cassette holder (optional)
• Mattress (optional)
• Compression belt (optional)
• Second set of foot pedals (optional)
Radiographic wall stand
• Front panel of the radiographic wall stand
• Lateral arm rest (optional)
• Patient hand grips (optional)
DR Detector
• DR Detector
DR 600 | Introduction | 19
3261K EN 20210708 0808

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, refer to these manuals:
• User manuals for the supported DR Detectors.
Related Links
Radiographic Table Accessories on page 202
Radiographic Wall Stand Accessories on page 213
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3261K EN 20210708 0808