AGFA DR 14s User manual
DR 14s
Pixium 3543 EZ
User Manual
0350B EN 20190319 1349 *
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
Options and Accessories ...........................................16
Anti-scatter grids ......................................... 16
Operation Controls .................................................. 17
DR 14s ......................................................... 18
DR Detector Battery Charger ........................ 19
DR Detector Switch on the NX Workstation ....
20
IR Data Communication Unit ....................... 22
Wireless Access Point ................................... 23
Using the Toggle Wifi button in the NX software to
switch between the wireless DR Detector and the
wireless hospital network .............................24
System Documentation ............................................25
Wireless access point ...................................25
Training ...................................................................26
Product Complaints ................................................. 27
Compatibility ...........................................................28
Compliance ............................................................. 29
General ........................................................30
Safety .......................................................... 30
Electromagnetic Compatibility .....................30
Radio Frequency .......................................... 31
Connectivity ............................................................ 33
Wireless Communication ............................. 33
Installation .............................................................. 34
Environment of Use ..................................... 34
Messages ................................................................. 36
Labels ...................................................................... 37
Additional Labeling of the DR Detector ........ 40
Additional Labeling of the DR Detector battery
41
Additional Labeling of the DR Detector battery
charger ........................................................ 42
ii | DR 14s | Contents
0350B EN 20190319 1349 *
Consulting the About box .............................43
Cleaning and Disinfecting ........................................ 44
Cleaning ...................................................... 45
Use of protective plastic bag .........................46
Disinfecting ................................................. 47
Approved disinfectants ................................ 48
Safety directions for disinfection .................. 49
Maintenance ............................................................50
Daily inspection ........................................... 51
Yearly inspection ..........................................52
Regular Inspection and Maintenance ........... 53
Replacement Parts Support ..........................54
Repair ..........................................................55
Patient data security ................................................ 56
Environmental Protection ........................................ 57
Safety Directions ......................................................58
DR Detector Battery .....................................62
Safety directions for the power supply ..........64
Getting started .....................................................................66
Starting the DR Detector .......................................... 67
Basic Workflow DR Detector .................................... 69
Step 1: retrieve the patient info ....................70
Step 2: select the exposure ...........................70
Step 3: prepare the exposure ........................71
Step 4: check the exposure settings .............. 72
Step 5: execute the exposure ........................73
Positioning the DR Detector ......................... 74
Guidelines for Pediatric Applications ....................... 77
Stopping the DR Detector .........................................79
Automatically turning the DR Detector to sleep
80
Automatically turning off DR Detector ......... 80
Automatic exposure detection ..................................81
Attaching the Handle Unit without Grid ...................82
Attaching the Handle Unit with Grid ........................83
Advanced Operating ............................................................ 84
Detector Status Indicators ........................................85
Charging a battery ................................................... 86
Inserting the battery in the battery charger ....
87
Battery charger indicator lights ....................88
First use of a new battery ......................................... 90
Storing a battery ...................................................... 91
Storage conditions ....................................... 91
Sharing the DR Detector between NX Workstations ....
92
Registering the DR Detector to an NX Workstation
using automatic registration ........................ 93
Registering the DR Detector to an NX Workstation
using the DR 10s DR 14s Registration Tool ... 94
DR 14s | Contents | iii
0350B EN 20190319 1349 *
Renewing the EPS license ........................................ 96
Problem solving ...................................................................98
Artifact in DR Detector images ................................. 99
Identifying problems ..............................................100
Battery thermal protection ......................... 101
Technical Data ................................................................... 102
DR 14s ................................................................... 103
X-ray performance ..................................... 105
DR 10s, DR 14s Battery ...........................................107
DR 10s, DR 14s Battery Charger ............................. 108
Remarks for HF-emission and immunity ............................ 109
EMC (Electromagnetic Compatibility) Statements ..110
Precautions on EMC ............................................... 111
Electromagnetic emissions ..................................... 112
Electromagnetic immunity ..................................... 113
Recommended separation distance ........................ 117
For U.S.A. ...............................................................118
iv | DR 14s | Contents
0350B EN 20190319 1349 *
Legal Notice
0459
THALES AVS FRANCE SAS, 460 rue du Pommarin, 38430 MOIRANS
FRANCE
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 10s and DR 14s 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 2019 Agfa NV
All rights reserved.
Published by Agfa NV
B-2640 Mortsel - Belgium.
No part of this document may be reproduced, copied, adapted or transmitted
in any form or by any means without the written permission of Agfa NV
DR 14s | Legal Notice | 5
0350B EN 20190319 1349 *
Scope
This manual contains information for the safe and effective operation of the
DR 14s DR Detector and peripheral equipment, further referred to as the DR
Detector.
DR 14s | Introduction to this Manual | 7
0350B EN 20190319 1349 *
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 14s | Introduction to this Manual
0350B EN 20190319 1349 *
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 14s | Introduction to this Manual | 9
0350B EN 20190319 1349 *
Introduction to the DR Detector
Topics:
•Intended Use
•Indications for Use
•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 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
Intended Use
The DR Detector is a wireless 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 14s | Introduction to the DR Detector | 11
0350B EN 20190319 1349 *
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.
2
3
7
5
1
4
6
1. DR Detector
2. DR Detector battery
3. DR Detector battery charger
4. IR data communication unit
5. Wireless access point
6. Network switch
7. Workstation
Figure 1: DR Detector configuration
12
3
12 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, the DR Detector, including the battery pack, is classified as
following.
Class I equipment Internally powered
Type B equipment A Type B piece of equipment is one that provides a
particular degree of protection against electric shock
particularly regarding allowable leakage current and
reliability of the protective earth protection.
Applied Parts The DR Detector tube side is an applied part.
Water ingress IP43
Protection against spraying water.
Flammable anesthet-
ics
This device is not suitable for use in the presence of a
flammable anesthetic mixture with air, or in pres-
ence of a flammable anesthetic mixture with oxygen
or nitrous oxide.
Operation Continuous operation.
Estimated product
life (if regularly serv-
iced and maintained
according to Agfa in-
structions)
Up to ten (10) years
The minimal total dose that the panel shall absorb
during its lifetime is 100 Gy at RQA5
Non-medical equipment
Following components are classified as non-medical equipment:
• DR Detector battery charger
• IR data communication unit
• Wireless access point
• Network switch
• Workstation
• DR Generator Sync Box
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
14 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
Figure 3: Patient’s vicinity
DR 14s | Introduction to the DR Detector | 15
0350B EN 20190319 1349 *
Options and Accessories
• DR Detector battery
• DR Detector battery charger
• Click-on grid
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 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
Operation Controls
Topics:
•DR 14s
•DR Detector Battery Charger
•DR Detector Switch on the NX Workstation
•IR Data Communication Unit
•Wireless Access Point
•Using the Toggle Wifi button in the NX software to switch between the
wireless DR Detector and the wireless hospital network
DR 14s | Introduction to the DR Detector | 17
0350B EN 20190319 1349 *
DR 14s
34
2
1
5
1. Effective imaging area border and center position indication
2. Control panel
3. DR Detector battery lock lever
4. DR Detector battery
5. Antenna of the wireless network adapter
Figure 4: DR Detector operation controls
1
2
3
5 6 674
1. Battery indicator
2. Wifi indicator
3. Status indicator
4. IR data port: communication port for the detector link (registration/
connection).
5. On/off switch
6. Magnets for DR Detector connector
7. DR Detector cable connector
Figure 5: DR Detector control panel
Related Links
Detector Status Indicators on page 85
18 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
DR Detector Battery Charger
The battery charger has three slots to insert a battery.
1
1. Battery status indicator light
Figure 6: DR Detector Battery Charger
Related Links
Charging a battery on page 86
DR 10s, DR 14s Battery on page 107
DR 10s, DR 14s Battery Charger on page 108
Safety directions for the power supply on page 64
Non-medical equipment on page 14
DR 14s | Introduction to the DR Detector | 19
0350B EN 20190319 1349 *
DR Detector Switch on the NX Workstation
The DR Detector Switch is available in the title bar of the NX application. 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.
It is positioned in the title bar of the NX application.
Battery status
icon
(empty)
Meaning Full Medium Low Empty Wired DR Detector
Wireless DR Detector is off
or disconnected
Connec-
tion status
icon (wi-
fi/wired)
(empty)
Meaning Good Low Bad Wired DR
Detector
DR Detec-
tor is off or
disconnec-
ted
DR Detec-
tor status
icon (blinking)
(empty)
20 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
This manual suits for next models
1
Table of contents
Other AGFA Medical Equipment manuals
