AGFA DX-D 45C User manual

DX-D 45C, DX-D 45G
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User Manual
0292B EN 20190401 1627

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 ......................................... 15
Non-medical equipment ...............................15
Options and Accessories ...........................................16
Anti-scatter grids ......................................... 17
DR Detector cable ........................................ 18
Operation Controls .................................................. 19
DX-D 45C, DX-D 45G ....................................20
DR Detector Battery Charger ........................21
DR Detector Dual Battery Charger ................22
System Control Unit .....................................23
DR Detector Switch on the NX Workstation ....
24
System Documentation ............................................26
Wireless access point ...................................26
Training ...................................................................27
Product Complaints ................................................. 28
Compatibility ...........................................................29
Compliance ............................................................. 30
General ........................................................31
Safety .......................................................... 31
Electromagnetic Compatibility ..................... 31
Radio Frequency ..........................................32
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
43
Additional Labeling of the DR Detector battery
charger ........................................................ 44
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Additional Labeling of the System Control Unit
45
Additional Labeling of the Mini System Control
Unit ............................................................. 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
Cleaning the interior of the battery slot ........54
Maintenance ............................................................55
Daily inspection ........................................... 56
Half-yearly inspection .................................. 57
Regular Inspection and Maintenance ........... 58
Replacement Parts Support ..........................59
Repair ..........................................................60
Patient data security ................................................ 61
Environmental Protection ........................................ 62
Safety Directions ......................................................63
DR Detector Battery ..................................... 67
Safety directions for the power supply ..........69
Safety directions for the System Control Unit ...
71
Getting started .....................................................................72
Starting the DR Detector .......................................... 73
Basic Workflow DR Detector .................................... 76
Step 1: retrieve the patient info ....................77
Step 2: select the exposure ...........................77
Step 3: prepare the exposure ........................78
Step 4: check the exposure settings ..............79
Step 5: execute the exposure ........................80
Step 6: perform a quality control ..................81
Positioning the DR Detector ......................... 82
Guidelines for Pediatric Applications ....................... 84
Stopping the DR Detector .........................................86
Automatic exposure detection ..................................88
Advanced Operating ............................................................ 89
Detector Status Indicators ........................................90
Charging a battery ................................................... 91
Inserting a battery in the battery charger ..... 92
Charging the battery using the DR detector cable
..........................................................................93
Registering the DR Detector on another NX Workstation
......................................................................................94
Using the Windows wifi settings to switch between the
wireless DR detector and the wireless hospital network
96
Problem solving ...................................................................98
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Artifact in DR Detector images ................................. 99
DR detector not ready for exposure ........................ 100
Password requested when connecting to the DR Detector
via the wireless network .........................................101
Images are not sent to the printer or to the PACS archive
....................................................................................102
Identifying problems ..............................................103
Technical Data ................................................................... 105
DX-D 45C, DX-D 45G ..............................................106
DX-D 45C, DX-D 45G Battery ..................................108
DX-D 45C, DX-D 45G Battery Charger .................... 109
DR Detector Dual Battery Charger .......................... 110
System Control Unit ............................................... 111
Mini System Control Unit ....................................... 112
Remarks for HF-emission and immunity .............................113
EMC (Electromagnetic Compatibility) Statements .. 114
Electromagnetic emissions ..................................... 115
Electromagnetic immunity ..................................... 116
For U.S.A. ...............................................................119
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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. DX-D 45C and DX-D 45G 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
DX-D 45C, DX-D 45G | Legal Notice | 5
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Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
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Scope
This manual contains information for the safe and effective operation of the
DX-D 45C and DX-D 45G wireless DR Detectors and peripheral equipment,
further referred to as the DR Detector.
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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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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.
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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
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Intended Use
The DR Detector is a wired and wireless radiographic digital X-ray imaging
device commonly referred to as flat panel detector. It is designed for all
general radiography applications. The DR Detector will be used in a
radiological environment by qualified staff to capture the X-ray images and
send these images to the imaging processing software.
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.
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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. A DR Detector can be shared between multiple
workstations.
2
7 8
6
9
4
5
1
3
1. DR Detector
2. DR Detector battery
3. DR Detector battery charger
4. System Control Unit (including a wireless access point)
5. Workstation
6. Wireless access point
7. Communication via System Control Unit
8. Communication via wireless access point
9. Communication via internal wireless adapter
Figure 1: DR Detector configuration with automatic exposure detection
A DR Detector cannot be configured to communicate to more than one
workstation via the internal wireless adapter of the workstation.
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2
3
4
1
1. DR Detector
2. DR Detector connector cable (wired configuration)
3. System Control Unit
4. Workstation
Figure 2: DR Detector configuration (wired)
6
5
1
4
3
2
1. DR Detector
2. DR Detector battery
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3. DR Detector battery charger
4. X-ray generator
5. System Control Unit (including a wireless access point)
6. Workstation
Figure 3: DR Detector configuration with X-ray generator synchronization
Related Links
Automatic exposure detection on page 88
Registering the DR Detector on another NX Workstation on page 94
Using the Windows wifi settings to switch between the wireless DR detector and
the wireless hospital network on page 96
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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 equip-
ment
Internally powered
Type B equip-
ment
A Type B piece of equipment is one that provides a partic-
ular degree of protection against electric shock particular-
ly regarding allowable leakage current and reliability of
the protective earth protection.
Water ingress IP53
This device is protected against spraying water.
Flammable an-
esthetics
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 ox-
ide.
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 charger
• System Control Unit
• Workstation
DX-D 45C, DX-D 45G | Introduction to the DR Detector | 15
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Options and Accessories
• DR Detector battery
• 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.
Topics:
•Anti-scatter grids
•DR Detector cable
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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
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DR Detector cable
The DR Detector cable connects the DR Detector to the System Control Unit.
The DR Detector cable can be used for two different functions. Which of two
functions is enabled, is selected at installation. Both functions cannot be
enabled on the same detector.
1. The DR Detector is configured for wireless operation. The cable is used for
registering a shared DR Detector on another NX workstation.
2. The DR Detector is configured for wired operation. The cable is used to
power the DR Detector and to transmit image data.
Related Links
Registering the DR Detector on another NX Workstation on page 94
Charging the battery using the DR detector cable on page 93
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Operation Controls
Topics:
•DX-D 45C, DX-D 45G
•DR Detector Battery Charger
•DR Detector Dual Battery Charger
•System Control Unit
•DR Detector Switch on the NX Workstation
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DX-D 45C, DX-D 45G
S



4
1
6
4
2
85 7
3
9
1. DR Detector battery
Supplies power to the detector during wireless communication.
2. DR Detector battery lock lever
Unlock the battery.
3. Battery status indicator
4. Antenna of the wireless network adapter
Operation in wireless configuration.
5. On/off switch
6. Status indicators
• Blue indicator shows data communication status.
• Orange indicator shows if the detector is ready.
• Green indicator shows power on/off status of the detector.
7. S-button
No function is attributed.
8. DR Detector connector
Operation in wired configuration.
9. Effective imaging area border and center position indication
Figure 4: DR Detector operation controls
Related Links
Detector Status Indicators on page 90
DX-D 45C, DX-D 45G on page 106
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