AGFA DR 10e User manual

DR 10e, DR 14e, DR 17e
DR 10e C (6011/111)
DR 14e C (6011/101)
DR 14e G (6011/102)
DR 17e C (6011/103)
DR 17e G (6011/104)
User Manual
0370C EN 20200228 1449

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 ................................................... 11
Intended User .......................................................... 11
Configuration .......................................................... 12
Equipment Classification ..........................................14
Non-medical equipment ...............................14
Accessories .............................................................. 16
Anti-scatter grids ......................................... 16
Operation Controls .................................................. 17
DR 10e, DR 14e, DR 17e ............................... 18
DR Detector Battery Charger ........................20
DR Detector Switch on the NX Workstation ....
21
Wireless Access Point ................................... 23
DR Detector connector cable and power box ....
24
DR Detector registration cable ......................27
System Documentation ............................................28
Wireless access point ...................................28
Training ...................................................................29
Product Complaints ................................................. 30
Compatibility ...........................................................31
Compliance ............................................................. 32
General ........................................................33
Safety .......................................................... 33
Electromagnetic Compatibility .....................33
Connectivity ............................................................ 34
Wireless Communication ............................. 35
Wired communication ................................. 36
Installation .............................................................. 37
Environment of Use ..................................... 37
Messages ................................................................. 39
Labels ...................................................................... 40
Additional Labeling of the DR Detector ........ 43
Additional Labeling of the DR Detector battery
44
Additional Labeling of the DR Detector battery
charger ........................................................ 45
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0370C EN 20200228 1449

Additional Labeling of the DR Detector power box
..........................................................................46
Consulting the About box .............................47
Cleaning and Disinfecting ........................................48
Cleaning ...................................................... 49
Use of protective plastic bag .........................50
Disinfecting ................................................. 51
Approved disinfectants ................................ 52
Safety directions for disinfection ..................53
Maintenance ............................................................54
Yearly inspection ..........................................55
Regular Inspection and Maintenance ........... 56
Replacement Parts Support ..........................57
Repair ..........................................................58
Patient data security ................................................ 59
Environmental Protection ........................................ 60
Disposal .......................................................60
Safety Directions ......................................................62
Safety Directions for the DR Detector battery ...
66
Safety Directions for the DR Detector power box
..........................................................................70
Safety directions for the power supply ..........71
Getting started .....................................................................73
Starting the DR Detector (wireless configuration) .... 74
Starting the DR Detector (wired configuration) ....... 77
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
Positioning the DR 10e .................................83
Positioning the DR 14e .................................85
Positioning the DR 17e .................................88
Guidelines for Pediatric Applications ....................... 90
Stopping the DR Detector (wireless configuration) ....
92
Automatically turning the DR Detector to sleep
94
Automatically turning off DR Detector ......... 94
Stopping the DR Detector (wired configuration) ...... 95
Automatic exposure detection ..................................96
Attaching the Handle Unit without Grid ...................97
Attaching the Handle Unit with Grid ....................................98
Advanced Operating ............................................................ 99
Detector Status Indicators ...................................... 100
Battery Status Indicator ..........................................101
Charging a battery ................................................. 102
DR 10e, DR 14e, DR 17e | Contents | iii
0370C EN 20200228 1449

Inserting the battery in the battery charger ....
103
Battery charger indicator lights ..................104
First use of a new battery ........................... 105
Storing a battery .................................................... 106
Storage conditions ..................................... 106
Registering the DR Detector on another NX Workstation
....................................................................................107
Renewing the EPS license ...................................... 108
Problem solving ................................................................. 110
Artifact in DR Detector images ................................111
DR Detector status is not changing to ready for exposure
.................................................................................... 111
DR Detector is not switched to standby or switched off
automatically .........................................................112
A program is preventing Windows from logging off ....
113
Identifying problems .............................................. 114
Technical Data ................................................................... 115
DR 10e, DR 14e, DR 17e ......................................... 116
DR 10e, DR 14e, DR 17e Battery ............................. 118
DR 10e, DR 14e, DR 17e Battery Charger ................ 119
DR 10e, DR 14e, DR 17e Power Box ........................120
Remarks for HF-emission and immunity .............................121
EMC (Electromagnetic Compatibility) Statements . 122
Precautions on EMC ...............................................123
Cables, transducers and accessories ....................... 125
Electromagnetic emissions .....................................126
Electromagnetic immunity .....................................127
Recommended separation distance ........................ 131
For U.S.A. and Canada ........................................... 132
iv | DR 10e, DR 14e, DR 17e | Contents
0370C EN 20200228 1449

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 10e, DR 14e and DR 17e 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 2020 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 10e, DR 14e, DR 17e | Legal Notice | 5
0370C EN 20200228 1449

Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
6 | DR 10e, DR 14e, DR 17e | Introduction to this Manual
0370C EN 20200228 1449

Scope
This manual contains information for the safe and effective operation of the
DR 10e, DR 14e and DR 17e wireless DR Detectors and peripheral equipment,
further referred to as the DR Detector.
DR 10e, DR 14e, DR 17e | Introduction to this Manual | 7
0370C EN 20200228 1449

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 | DR 10e, DR 14e, DR 17e | Introduction to this Manual
0370C EN 20200228 1449

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 10e, DR 14e, DR 17e | Introduction to this Manual | 9
0370C EN 20200228 1449

Introduction to the DR Detector
Topics:
•Intended Use
•Indications for Use
•Intended User
•Configuration
•Equipment Classification
•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 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449

Intended Use
The DR Detector is a wireless or wired radiographic digital X-ray imaging
device commonly referred to as flat panel detector. It is designed for general
radiography applications. The DR Detector will be used in a radiological
environment by qualified staff to capture and route static X-ray images.
The DR Detector is not intended for mammography applications.
Indications for Use
The DR Retrofit solution is indicated for use in general projection
radiographic applications to capture for display diagnostic quality
radiographic images of human anatomy. 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.
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.
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 11
0370C EN 20200228 1449

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 workstation.
1
2
7
5
3
6
9
1110
8
4
6
1. DR Detector battery
2. DR Detector battery charger
3. DR Detector
4. DR Detector registration cable (wireless configuration)
This cable is only required to register the DR Detector on another NX
Workstation.
5. Wireless access point
6. Network switch (optional)
7. Workstation
8. DR Detector connector cable (wired configuration)
9. Power box
10. Wireless configuration
11. Wired configuration
Figure 1: DR Detector configuration
The wired and wireless configurations can be combined.
12 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449

12
1. X-ray generator synchronization through the DR Generator Sync Box
2. Automatic exposure detection
Figure 2: DR Detector synchronization
Both synchronization methods are available on the wired configuration as
well.
Related Links
Automatic exposure detection on page 96
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 13
0370C EN 20200228 1449

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 protec-
tion agains elec-
trical shock
Internally powered (wireless configuration)
Class I equipment (wired configuration)
Type B equip-
ment
A Type B piece of equipment is one that provides a par-
ticular degree of protection against electric shock partic-
ularly regarding allowable leakage current and reliability
of the protective earth protection.
Water ingress IPX0
(The DR detector conforms to IPX3)
Flammable anes-
thetics
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:
• DR Detector battery
• DR Detector battery charger
• Wireless access point
• Network switch
• Workstation
• DR Generator Sync Box
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
14 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449

Figure 3: Patient’s vicinity
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 15
0370C EN 20200228 1449

Accessories
• DR Detector battery
• DR Detector battery charger
• Power box with DR Detector connector cable
• DR Detector registration cable
• Click-on grid
• Cover plates for the battery bay and for the connector for the cable
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.
Anti-scatter grids
Anti-scatter grids are used to reduce scattered radiation and improve image
quality. Grids are available as an option.
Refer to the Agfa website for specifications on the anti-scatter grids that have
been found compatible with the system and the DR Detectors.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=54332498
16 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449

Operation Controls
Topics:
•DR 10e, DR 14e, DR 17e
•DR Detector Battery Charger
•DR Detector Switch on the NX Workstation
•Wireless Access Point
•DR Detector connector cable and power box
•DR Detector registration cable
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 17
0370C EN 20200228 1449

DR 10e, DR 14e, DR 17e



1 4
5
6
23
7
7



5
1 4
5
6
2 3
6
7
7



5
1 4
5
6
2 3
6
7
7
1. Effective imaging area border and center position indication
2. DR Detector battery lock lever
3. DR Detector battery
4. Battery status indicator
5. DR Detector status indicators
6. DR Detector cable connector
18 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449

7. Antenna of the wireless network adapter
Figure 4: DR Detector operation controls



1



3



4
2
1. Ready indicator
2. Power indicator
3. Error indicator
4. Link indicator
Figure 5: DR Detector status indicators
Related Links
Detector Status Indicators on page 100
Introduction to this Manual on page 6
DR 10e, DR 14e, DR 17e | Introduction to the DR Detector | 19
0370C EN 20200228 1449

DR Detector Battery Charger
The battery charger has two slots to insert a battery.
1
1. Battery status indicator light
Figure 6: DR Detector Battery Charger
Related Links
Safety directions for the power supply on page 71
Charging a battery on page 102
Battery charger indicator lights on page 104
DR 10e, DR 14e, DR 17e Battery Charger on page 119
Non-medical equipment on page 14
20 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449