AGFA XD 10 User manual

XD 10, XD⁺10
FXRD-2530VAW
FXRD-2530VAW PLUS
User Manual
0432A EN 20210426 1355

Contents
Legal Notice ..........................................................................5
Introduction to this Manual ................................................... 6
Scope .........................................................................7
About the safety notices in this document .................. 8
Disclaimer ................................................................. 9
Introduction to the DR Detector ........................................... 10
Intended use ............................................................11
Indications for use of the DR Retrofit solution .......... 12
Intended User .......................................................... 13
Configuration .......................................................... 14
Equipment Classification ..........................................16
Non-medical equipment ...............................16
Options and Accessories ...........................................17
Operation Controls .................................................. 18
XD 10, XD⁺10 ............................................... 19
DR detector cradle ....................................... 21
DR Detector dual battery charger .................22
System Control Unit .....................................23
System Control Unit Lite .............................. 24
DR detector cable .........................................25
DR Detector Switch ......................................26
System Documentation ............................................28
Wireless access point ...................................28
Training ...................................................................29
Product Complaints ................................................. 30
Compatibility ...........................................................31
Compliance ............................................................. 32
General ........................................................33
Safety .......................................................... 33
Electromagnetic Compatibility .....................33
Radio Frequency ..........................................33
Connectivity ............................................................ 35
Wireless Communication ............................. 36
Wired communication ..................................37
Installation .............................................................. 38
Environment of Use ..................................... 38
Messages ................................................................. 40
Labels ...................................................................... 41
Additional labeling of the DR detector ......... 44
Additional labeling of the DR detector battery ..
45
Additional labeling of the DR detector cradle ...
46
Additional labeling of the DR detector dual battery
charger ........................................................ 47
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0432A EN 20210426 1355

Additional Labeling of the System Control Unit
48
Additional Labeling of the Mini System Control
Unit ............................................................. 49
Additional Labeling of the System Control Unit
Lite .............................................................. 50
Consulting the About box .............................51
Cleaning and Disinfecting ........................................ 52
Cleaning ...................................................... 53
Use of protective plastic bag .........................54
Disinfecting ................................................. 55
Approved disinfectants ................................ 56
Safety directions for disinfection .................. 57
Maintenance ............................................................58
Daily inspection ........................................... 59
Half-yearly inspection .................................. 59
Regular Inspection and Maintenance ........... 60
Replacement Parts Support ..........................61
Repair ..........................................................62
Patient data security ................................................ 63
Requirements on the operating environment ...
63
Environmental Protection ........................................ 65
Safety Directions ......................................................66
Safety directions for the power supply ..........70
Safety directions for the System Control Unit ...
72
Safety directions for the DR detector battery ....
73
Getting started .....................................................................75
Starting the DR detector ...........................................76
Basic Workflow DR Detector .................................... 78
Step 1: retrieve the patient info .................... 79
Step 2: select the exposure ...........................79
Step 3: prepare the exposure ........................80
Step 4: check the exposure settings .............. 81
Step 5: execute the exposure ........................82
Step 6: perform a quality control ..................83
Positioning the XD 10, XD⁺10 .......................84
Offline image acquisition workflow ......................... 86
Guidelines for Pediatric Applications ....................... 90
Stopping the DR detector ......................................... 92
Automatic exposure detection ..................................93
Advanced Operating ............................................................ 94
Viewing the detector status ......................................95
Battery status ...............................................96
Connection status ........................................ 97
Charging a battery ................................................... 98
Charging the DR detector in the DR detector
cradle .......................................................... 99
XD 10, XD⁺10 | Contents | iii
0432A EN 20210426 1355

Charging the DR detector using the power adapter
........................................................................100
Charging the battery using the DR detector cable
........................................................................101
Charging a battery in the dual battery charger .
102
Replacing the battery ............................................. 103
Managing network connections in client mode
configuration ......................................................... 104
Connecting to another MUSICA Acquisition
Workstation (client mode) ......................... 104
Managing network connections in access point mode
configuration ......................................................... 106
Switching between the wireless DR detector and
the wireless hospital network ..................... 107
Switching temporarily to client mode ........ 109
Connecting the MUSICA Acquisition Workstation
to another DR detector (access point mode) ....
110
Problem solving ................................................................. 111
Artifact in DR Detector images ............................... 112
DR detector not ready for exposure ........................ 113
The MUSICA Acquisition Workstation is connected to the
DR detector, but the DR detector is not active (access point
mode) ....................................................................115
Images are not sent to the printer or to the PACS archive
.................................................................................... 116
Identifying problems .............................................. 117
Technical Data ................................................................... 119
XD 10, XD⁺10 technical data .................................. 120
DR detector battery technical data ......................... 122
DR detector cradle technical data ...........................123
DR detector dual battery charger technical data .....124
System Control Unit ...............................................125
Mini System Control Unit .......................................126
System Control Unit Lite ........................................ 127
Remarks for HF-emission and immunity ............................ 128
EMC (Electromagnetic Compatibility) Statements . 129
Electromagnetic emissions .....................................130
Electromagnetic immunity ..................................... 131
For U.S.A. .............................................................. 134
iv | XD 10, XD⁺10 | Contents
0432A EN 20210426 1355

Legal Notice
2460
Vieworks Co., Ltd. (Gwanyang-dong), 41-3, Burim-ro 170beon-gil,
Dongan-gu, Anyang-si, Gyeonggi-do, Korea
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. XD 10 and XD⁺10 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 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
XD 10, XD⁺10 | Legal Notice | 5
0432A EN 20210426 1355

Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
6 | XD 10, XD⁺10 | Introduction to this Manual
0432A EN 20210426 1355

Scope
This manual contains information for the safe and effective operation of the
XD 10 and XD⁺10 wireless DR detectors and peripheral equipment, further
referred to as the DR detector.
XD 10, XD⁺10 | Introduction to this Manual | 7
0432A EN 20210426 1355

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.
8 | XD 10, XD⁺10 | Introduction to this Manual
0432A EN 20210426 1355

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.
XD 10, XD⁺10 | Introduction to this Manual | 9
0432A EN 20210426 1355

Introduction to the DR Detector
Topics:
•Intended use
•Indications for use of the DR Retrofit solution
•Intended User
•Configuration
•Equipment Classification
•Options and Accessories
•Operation Controls
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Messages
•Labels
•Cleaning and Disinfecting
•Maintenance
•Patient data security
•Environmental Protection
•Safety Directions
10 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355

Intended use
Indications for use
The XD 10 and XD⁺10 DR detectors are a digital X-ray imaging solution. They
acquire images by detecting X-rays that has been passed through the human
body. When X-ray photons pass through the scintillator in the detector, the
photons convert to visible ray, and the visible ray is converted to electronic
signals through TFTs – thin film transistors (a-Si). Then the detector
digitalizes X-ray images and transfers them to the PC (workstation) for
diagnostic review using an image display monitor. Advanced digital image
processing also allows efficient diagnosis, information management, and
sharing of image information over the network.
The XD 10 and XD⁺10 DR detectors are used for the general-purpose
diagnostic procedures, and as well as intended to replace radiographic film/
screen systems.
The XD 10 and XD⁺10 DR detectors are not intended for mammography
applications.
XD 10, XD⁺10 | Introduction to the DR Detector | 11
0432A EN 20210426 1355

Indications for use of the DR Retrofit solution
The DR Retrofit solution is indicated for use in general projection
radiographic applications to capture for display diagnostic quality
radiographic images of human anatomy. The DR Retrofit solution may be used
wherever conventional screen-film systems may be used.
The DR Retrofit solution is not indicated for use in mammography.
12 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355

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.
Only a physician or a legally certified operator should use this product.
XD 10, XD⁺10 | Introduction to the DR Detector | 13
0432A EN 20210426 1355

Configuration
The DR detector is a component that can be integrated in an X-ray system and
that communicates to a workstation. Multiple DR detectors can communicate
to a single MUSICA Acquisition Workstation. A DR detector can be used on
more than one MUSICA Acquisition Workstation.
1 2
8
3
6
7
5
9
4
1. Client mode: the detector connects to the workstation via the built-in
access point of the System Control Unit (SCU).
2. Client mode: the detector connects to the workstation via a wireless
access point.
3. Access point mode: the workstation connects to the detector, which is
acting as an access point.
4. Wired mode: the detector communicates to the workstation via the DR
detector cable.
5. DR detector
6. System Control Unit (including a wireless access point)
7. Workstation
8. Wireless access point
9. DR detector cable
Figure 1: Configurations
A DR detector is during installation configured either in client mode or in
access point mode.
14 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355

Related Links
Managing network connections in client mode configuration on page 104
Managing network connections in access point mode configuration on page 106
XD 10, XD⁺10 | Introduction to the DR Detector | 15
0432A EN 20210426 1355

Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety, the DR Detector, including the battery pack, is classified as following.
Type of protection
against electrical shock
Internally powered (wireless configuration)
Class I equipment (wired configuration)
Degree of protection
against electrical shock
Type B applied parts
Degree of protection
against ingress of water
and dust
IP67
(degrees of protection against ingress of water
and dust provided by enclosure)
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.
Applied Parts The DR detector tube side is an applied part.
Expected service life Up to seven (7) years
(if regularly serviced and maintained according to
Agfa instructions)
Non-medical equipment
Following components are classified as non-medical equipment:
• System Control Unit (SCU)
• DR detector cradle
• DR detector battery charger
• Workstation
16 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355

Options and Accessories
• DR detector cradle
• DR detector battery
• Power adapter with USB Type-C cable
• DR detector battery charger
The delivery contains a set of labels. When using multiple DR Detector, 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.
XD 10, XD⁺10 | Introduction to the DR Detector | 17
0432A EN 20210426 1355

Operation Controls
Topics:
•XD 10, XD ⁺ 10
•DR detector cradle
•DR Detector dual battery charger
•System Control Unit
•System Control Unit Lite
•DR detector cable
•DR Detector Switch
18 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355

XD 10, XD⁺10
1 2 3 4 5 6 7 8
44
1. Power button with indicator light
• Press to start the DR detector or to display the status of the DR
detector.
• Press and hold for 3 seconds to stop the DR detector.
2. AP mode button
• Press to display the status of the DR detector.
• Press and hold for 3 seconds to change the network connection.
3. Status display
• Battery status
• Connection status
• IP address
• SSID name
4. Antenna of the wireless network adapter
Operation in wireless configuration.
5. Battery status indicator
6. Connector for power adapter (USB Type-C)
7. DR detector connector
• Operation in wired configuration.
• Charging the battery.
8. Effective imaging area border and center position indication
Figure 2: DR detector operation controls
XD 10, XD⁺10 | Introduction to the DR Detector | 19
0432A EN 20210426 1355

21
1. Knobs securing the battery cover plate.
2. Cover plate for the DR detector battery
The battery supplies power to the detector during wireless
communication.
Figure 3: DR detector rear side
Related Links
Advanced Operating on page 94
XD 10, XD
⁺ 10 technical data on page 120
20 | XD 10, XD⁺10 | Introduction to the DR Detector
0432A EN 20210426 1355