AGFA DR 400 User Manual
DR 400
5520/100
5520/200
User Manual
3231A EN 20150710 1114
| DR 400 | Contents
2
Contents
Legal Notice ..........................................................................5
Introduction .......................................................................... 6
Introduction to this Manual ....................................... 7
Scope of this Manual ......................................8
Warnings, Cautions, Instructions and Notes ....
9
Disclaimer ................................................... 10
Introduction to DR 400 ............................................10
Intended Use ............................................... 11
Intended User .............................................. 12
Configuration .............................................. 13
Equipment Classification ............................. 16
Options and Accessories ...............................17
Operation Controls ...................................... 18
System Documentation ................................27
Training .......................................................28
Product Complaints ..................................... 29
Compatibility ...............................................30
Compliance ................................................. 31
Connectivity ................................................ 33
Installation .................................................. 34
Radiation Protection ....................................35
Labels .......................................................... 40
Cleaning and Disinfecting ............................ 46
Patient data security .................................... 49
Maintenance ................................................50
Environmental protection ............................ 53
Safety Directions ..........................................54
Getting started .....................................................................58
Starting the System ..................................................59
Basic workflow using the DR Detector ......................60
Step 1: retrieve the patient info ....................61
Step 2: select the exposure ...........................62
Step 3: prepare the exposure ........................63
Step 4: check the exposure settings .............. 64
Step 5: execute the exposure ........................65
Step 6: perform a quality control ..................66
Basic workflow using a CR cassette .......................... 67
Step 1: retrieve the patient info ....................68
Step 2: select the exposure ...........................69
Step 3: prepare the exposure ........................70
Step 4: check the exposure settings .............. 71
Step 5: execute the exposure ........................72
Step 6: repeat steps 2 to 5 for the next
subexposures ...............................................73
3231A EN 20150710 1114
DR 400 | Contents |
Step 7: digitize the image .............................74
Step 8: perform a quality control ..................75
X-Ray System Positioning ........................................ 76
RAD Table Exposures ...................................77
Oblique Exposures ....................................... 78
Lateral Exposures ........................................ 79
RAD Wall Stand Exposures .......................... 80
Guidelines for Pediatric Applications ....................... 81
Stopping the System ................................................ 83
Operation ............................................................................ 84
Tube head display ....................................................85
RAD Table and X-Ray Tube Stand ............................ 86
Positioning the X-Ray Tube Stand ................ 88
Positioning the RAD Table ........................... 91
Positioning the Bucky .................................. 93
RAD Table Accessories .................................94
RAD Wall Stand .......................................................96
Positioning the RAD Wall Stand ...................98
RAD Wall Stand Accessories .......................101
Bucky .................................................................... 104
Bucky configuration ...................................106
Rotating the bucky .....................................109
Loading of the bucky in the RAD Table .......110
Loading of the bucky in the RAD Wall Stand ....
111
Unloading of the bucky in the RAD Table ... 112
Unloading of the bucky in the RAD Wall Stand .
113
Centering and collimating ..........................114
Orientation of DX-D 10C, DX-D 10G in the bucky
........................................................................116
Grids ......................................................................118
Grid focal distance color indication ............119
Grid detection ............................................120
Storage box for DR Detector and grids ................... 121
Automatic Exposure Control (AEC) ........................122
Manual Collimator .................................................123
Dose Area Product Meter (DAP) .................123
Automatic Collimator ............................................ 125
Semi-automatic collimation mode ............. 127
Manual collimation mode .......................... 128
Dose Area Product Meter (DAP) .................129
Effect of SID on patient dose .................................. 130
X-Ray Generator Console .......................................131
Starting and stopping the generator ...........132
X-ray tube start-up modes ..........................133
X-ray generator messages and warning signals .
134
Exposure parameters ................................. 139
Problem solving .................................................................142
3
3231A EN 20150710 1114
4 | DR 400 | Contents
System messages ................................................... 143
Restoring connection between generator and NX after
generator failure ....................................................145
Automatic collimation always too wide or too narrow ..
146
Empty Bucky Failure, Double Exposure Failure ...... 147
NX does not connect to the generator due to ID tablet ..
148
No table movement ................................................149
DR Detector is Exceeding the Maximum Working
Temperature ..........................................................150
DR Detector must be Recalibrated ..........................151
Technical Data ...................................................................152
DR 400 Technical Data .......................................... 153
Environmental conditions ..........................154
Generator Technical Data ...................................... 155
RAD Table and X-Ray Tube Stand Technical Data .. 157
Movement ranges ...................................... 158
RAD Wall Stand Technical Data ............................. 160
X-Ray Tube Technical Data .................................... 162
Bucky Unit Technical Data ..................................... 164
Automatic Exposure Control (AEC) Technical Data ....
166
Ralco R221 Collimator Technical Data ...................167
Ralco R225 ACS Collimator Technical Data ........... 168
Dose Area Product Meter (DAP) Technical Data .....169
DX-D Fixed DR Detector Technical Data .................170
Portable DR Detector Technical Data ..................... 172
NX Workstation Technical Data ............................. 173
DR Generator Sync Box Technical Data ..................174
Remarks for HF-emission and immunity ............................ 175
Remarks for HF-emission and immunity ................ 176
Essential performance ........................................... 182
Cables, transducers and accessories ....................... 183
For type 5520/200 only ............................. 185
Optional .................................................... 185
Stray Radiation ..................................................................186
3231A EN 20150710 1114
DR 400 | Legal Notice | 5
Legal Notice
0413
Agfa HealthCare NV, Septestraat 27, B-2640 Mortsel - Belgium
For more information on Agfa products and Agfa HealthCare 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 HealthCare N.V., 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 HealthCare N.V. 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 HealthCare N.V. diligently strives to provide as
accurate information as possible, but shall not be responsible for any
typographical error. Agfa HealthCare N.V. 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 HealthCare
N.V. reserves the right to make changes to this document without prior notice.
The original version of this document is in English.
Copyright 2015 Agfa HealthCare N.V
All rights reserved.
Published by Agfa HealthCare N.V.
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
HealthCare N.V.
3231A EN 20150710 1114
6 | DR 400 | Introduction
Introduction
Topics:
• Introduction to this Manual
• Introduction to DR 400
3231A EN 20150710 1114
Introduction to this Manual
Topics:
• Scope of this Manual
• Warnings, Cautions, Instructions and Notes
• Disclaimer
DR 400 | Introduction | 7
3231A EN 20150710 1114
8 | DR 400 | Introduction
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.
3231A EN 20150710 1114
DR 400 | Introduction | 9
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.
3231A EN 20150710 1114
| DR 400 | Introduction
10
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.
Caution: In the United States, Federal law restricts this device to
sale by or on the order of a physician.
Introduction to DR 400
Topics:
• Intended Use
• Intended User
• Configuration
• Equipment Classification
• Options and Accessories
• Operation Controls
• System Documentation
• Training
• Product Complaints
• Compatibility
• Compliance
• Connectivity
• Installation
• Radiation Protection
• Labels
• Cleaning and Disinfecting
• Patient data security
• Maintenance
• Environmental protection
• Safety Directions
3231A EN 20150710 1114
DR 400 | Introduction | 11
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.
3231A EN 20150710 1114
12 | DR 400 | Introduction
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.
3231A EN 20150710 1114
DR 400 | Introduction |
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:
• RAD 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.
• RAD 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.
• X-ray tube stand mounted on the RAD Table
• X-ray generator integrated in the RAD Table
• X-ray generator 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)
Depending on the configuration the following components are also available:
• Portable DR Detector
DR 400 can be used in combination with:
13
• 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.
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
3231A EN 20150710 1114
2
3
6
4
5
1
| DR 400 | Introduction
14
• Position tracking for keeping constand SID on table and wall stand
• Bucky with automatic cassette size sensing (ACSS) and automatic
collimator
NX workstation
1.
X-ray tube stand mounted on RAD Table
2.
X-ray tube with collimator and tube head display
3.
Portable DR Detector
4.
RAD Table with integrated generator
5.
RAD Wall Stand
6.
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:
• RAD Table
• RAD Wall Stand
• DR Detector
RAD Table
• Table top of the RAD Table
• Patient hand grips (optional)
• Lateral cassette holder (optional)
3231A EN 20150710 1114
• Mattress (optional)
• Compression belt (optional)
RAD Wall Stand
• Front panel of the RAD Wall Stand
• Overhead arm support (optional)
• Patient hand grips (optional)
DR Detector
• DR Detector
DR 400 | Introduction | 15
3231A EN 20150710 1114
16 | DR 400 | Introduction
Equipment Classification
Per EN/IEC 60601-1:2005, EN/IEC 60601-2-54:2009, this device is classified
as following:
Table 1: Equipment classification
Class I equipment Equipment in which protection against electric
Type B equipment A Type B piece of equipment is one that provides a
Water ingress IP10
Cleaning See section on cleaning and disinfecting.
shock does not rely on basic insulation only, but
includes a fixed connection to mains power with
protective earth conductor.
particular degree of protection against electric
shock particularly regarding allowable leakage
current and reliability of the protective earth
protection.
This device does not have protection against
ingress of water.
Disinfection See section on cleaning and disinfecting.
Flammable anesthetics This device is not suitable for use in the presence of
Operation Continuous operation.
Related Links
Cleaning and Disinfecting on page 46
3231A EN 20150710 1114
a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
DR 400 | Introduction | 17
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
RAD Table Accessories on page 94
RAD Wall Stand Accessories on page 101
3231A EN 20150710 1114
18 | DR 400 | Introduction
Operation Controls
Topics:
• RAD Table
• RAD Wall Stand
• Control Panel of the X-Ray Tube Stand
• NX Application on the NX Workstation
• Software Console
• DR Detector Switch
• X-ray generator mini console
• Manual collimator
• Automatic collimator
• DR Detector
• Emergency stop button
• Emergency shutdown power switch
RAD Table
The RAD Table is used for positioning of the patient lying or sitting over the
detector or the cassette in the bucky for exposure.
The RAD Table supports the patient and the detector or the cassette for free
exposure.
Figure 2: RAD Table
Related Links
RAD Table and X-Ray Tube Stand
RAD Wall Stand
The RAD Wall Stand is used for positioning of patients standing upright or
sitting towards the bucky for exposure.
3231A EN 20150710 1114
Figure 3: RAD Wall Stand with vertical bucky
Related Links
RAD Wall Stand on page 96
Control Panel of the X-Ray Tube Stand
DR 400 | Introduction | 19
Figure 4: Control Panel of the X-Ray Tube Stand with tube head display
(controls for X-ray tube position and for X-ray exposure parameters)
Figure 5: Control Panel of the X-Ray Tube Stand with X-ray tube angle
display
Related Links
RAD Table and X-Ray Tube Stand on page 86
3231A EN 20150710 1114
Last name, first name
*June 10, 1960, 08154711032,
Chest PA
113 cm 35°
114 kV
+2
0.1 mm Cu
1 mm Al
Detector table
| DR 400 | Introduction
20
Tube head display
The tube head display can be used to control X-ray exposure parameters. It
displays the system status.
Figure 6: Example of the tube head display
Related Links
Tube head display on page 85
NX Application on the NX Workstation
The NX application is used to define patient information, select exposures and
process images.
Figure 7: the NX application
Software Console
The 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 Software Console is used to control the X-ray exposure settings.
The Software Console contains the DR Detector Switch.
3231A EN 20150710 1114
Figure 8: Software Console
DR 400 | Introduction | 21
DR Detector Switch
The DR Detector Switch is available in the device status frame of the 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.
The DR Detector Switch can be switched to CR, depending on the
configuration.
Figure 9: DR Detector Switch
DR Detector Status
Battery status icon
Meaning Full Medium Low Empty
Connection status icon (wifi/
wired)
3231A EN 20150710 1114
?
4 6
1 32
5
8
7
22 | DR 400 | Introduction
DR detector
status icon
Meaning Good Low Bad Wired DR Detector
(blinking)
Meaning Ready Initializing
exposure
Error Sleep One DR detector
X-ray generator mini console
The X-ray generator mini console is available in the operator room.
Power ON button
1.
Power ON indicator
2.
Power OFF button
3.
Press and hold to prepare for exposure
4.
Prepare ready indicator
5.
Press and hold to start the exposure
6.
Radiation indicator
7.
Exposure button
8.
Figure 10: X-ray generator mini console
must be selected
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.
3231A EN 20150710 1114
DR 400 | Introduction |
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.
23
Manual collimator
The collimator sets the exposure field and displays it by means of a light field.
The collimator provides X-ray filtering using the integrated filters or by
inserting a filter in the rails.
A DAP meter (Dose Area Product Meter) can be mounted on the collimator by
inserting it in the rails.
Figure 11: Collimator
Related Links
Ralco R221 Collimator Technical Data on page 167
Automatic collimator
The collimator sets the exposure field and displays it by means of a light field.
3231A EN 20150710 1114
24 | DR 400 | Introduction
The collimator provides X-ray filtering using the integrated filters or by
inserting a filter in the rails.
An integrated DAP meter (Dose Area Product Meter) in the collimator is
available as an option.
Figure 12: Collimator
Related Links
Automatic Collimator on page 125
Automatic Cassette Size Sensing on page 114
Ralco R225 ACS Collimator Technical Data on page 168
DR Detector
When performing an exposure, keep in mind the following detector
orientation aids:
1. Tube side
2. Patient orientation marker
For an overview of the operation controls of the DR Detector, refer to the user
manual of the DR Detector.
The DR Detector may come in contact with the patient.
3231A EN 20150710 1114
Note: DR Detectors that operate wireless contain an RF
transmitter. For detailed information, refer to the DR Detector
User Manual.
DR 400 | Introduction | 25
Emergency stop button
Figure 13: Emergency stop button
If a system malfunction causes an emergency situation involving the patient,
operating personnel or any system component, activate the emergency stop
on the RAD Table. All motor driven movements will be stopped.
Motor driven movements:
• RAD Table
• RAD Wall Stand
• X-ray tube stand
To allow motorized movements again, turn the cap of the emergency switch in
clockwise direction (default position).
Warning: The emergency stop button does not switch off the
voltage in the X-ray system.
Emergency shutdown power switch
Use the emergency shutdown power switch, if a dangerous situation cannot
be eliminated by pressing the emergency stop button.
Warning: Use the emergency shutdown power switch in
case of danger to patients, operators, third parties, or one of
the units. The entire system will be shut down and the
power supply will be disconnected.
The emergency shutdown power switch for the room is typically located on
the wall and easy to access, often close to the power off switch of the X-ray
system. It is installed and labeled by customer.
3231A EN 20150710 1114
26 | DR 400 | Introduction
Warning: It must be ensured that the emergency switches
are always freely accessible.
3231A EN 20150710 1114
DR 400 | Introduction | 27
System Documentation
The DR 400 user documentation consists of
• DR 400 User Documentation CD (digital media)
• NX User Documentation CD (digital media)
The DR 400 User Documentation CD contains:
• DR 400 User Manual (this document)
• DX-D Software Console, DR Tube Head Display User Manual, document
0389
• User manuals for the supported DR Detectors
• DX-D DR Detector Calibration Key User manual, document 0134
Other documentation available on the DR 400 User Documentation CD:
• DAP Datasheet
• X-ray Tube Documentation
• Collimator Datasheet
• AEC Datasheet
• X-ray Generator User Manual
• Test Report for IEC60601-1-3
• Test Report for DIN6868-150
3231A EN 20150710 1114
28 | DR 400 | Introduction
Training
The user must have received adequate training on the safe and effective use of
the system before attempting to work with it. Training requirements may vary
from country to country. The user must make sure that training is received in
accordance with local laws or regulations that have the force of law. Your
local Agfa or dealer representative can provide further information on
training.
The user must note the following information in the system documentation:
• Intended Use.
• Intended User.
• Safety Directions.
3231A EN 20150710 1114
DR 400 | Introduction | 29
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 the device malfunctions and may have caused or contributed to a serious
injury, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094
3231A EN 20150710 1114
30 | DR 400 | Introduction
Compatibility
The system must only be used in combination with other equipment or
components if these are expressly recognized by Agfa as compatible. A list of
such equipment and components is available from Agfa service on request.
Changes or additions to the equipment must only be carried out by persons
authorized to do so by Agfa. Such changes must comply with best engineering
practice and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
3231A EN 20150710 1114
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