AGFA DX-D 40C User manual

DX-D 40C, DX-D 40G
FXRD-1417WA
FXRD-1417WB
User Manual
0290A EN 20140626 1622

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
Documentation by the manufacturer ..............6
Warnings, Cautions, Instructions and Notes ...............7
Disclaimer ................................................................. 8
Introduction to the DR Detector .............................................9
Intended Use ........................................................... 10
Intended User ..........................................................10
Configuration .......................................................... 11
Equipment Classification ......................................... 12
Non-medical equipment .............................. 12
Options and Accessories ...........................................13
Recommended grid specifications ................13
Operation Controls .................................................. 14
DX-D 40C, DX-D 40G ................................... 15
DR Detector Battery Charger ........................16
System Control Unit .....................................17
DR Detector Switch on the NX Workstation ....
18
System Documentation ............................................19
Documentation by the manufacturer ............19
Training ...................................................................20
Product Complaints ................................................. 21
Compatibility ...........................................................22
Compliance ............................................................. 23
Documentation by the manufacturer ............23
Connectivity ............................................................ 24
Wireless Communication ............................. 25
Wired communication ................................. 26
Installation .............................................................. 27
Environment of Use ..................................... 27
Messages ................................................................. 29
Labels ...................................................................... 30
DR Detector identification label ................... 31
Documentation by the manufacturer ............32
Cleaning and Disinfecting ........................................33
Cleaning ...................................................... 34
Use of protective plastic bag .........................35
Disinfecting ................................................. 36
Approved disinfectants ................................ 37
Safety directions for disinfection ..................38
Maintenance ............................................................40
Daily inspection ........................................... 41
Half-yearly inspection ..................................42
2 | DX-D 40C, DX-D 40G | Contents
0290A EN 20140626 1622

Regular Inspection and Maintenance ........... 43
Replacement Parts Support ..........................44
Repair ..........................................................45
Environmental Protection ........................................46
Safety Directions ......................................................48
DR Detector Battery .....................................51
Safety directions for the power supply ......... 53
Safety directions for the System Control Unit ...
55
Getting started .....................................................................56
Starting the DR Detector ..........................................57
Basic Workflow DR Detector ....................................59
Step 1: retrieve the patient info ....................60
Step 2: select the exposure ...........................60
Step 3: prepare the exposure ........................61
Step 4: check the exposure settings .............. 62
Step 5: execute the exposure ........................63
Positioning the DR Detector .........................64
Guidelines for Pediatric Applications ....................... 67
Stopping the DR Detector ........................................ 69
Advanced Operating ............................................................ 70
Detector Status Indicators ........................................71
Charging a battery ................................................... 72
Problem solving ...................................................................73
Artifact in DR Detector images .................................74
DX-D 40C, DX-D 40G .............................................. 75
Technical Data .....................................................................77
DX-D 40C, DX-D 40G ............................................... 78
DX-D 40C, DX-D 40G Battery ................................... 80
DX-D 40C, DX-D 40G Battery Charger ......................81
System Control Unit .................................................82
Remarks for HF-emission and immunity .............................. 83
Documentation by the manufacturer ....................... 83
DX-D 40C, DX-D 40G | Contents | 3
0290A EN 20140626 1622

Legal Notice
0434
Vieworks Co., Ltd. #107-108, 601-610, Suntechcity 2, 52 Sagimakgol-ro
(307-2, Sangdaewon-dong), Jungwon-gu, Seongnam-si, Gyeonggi-do,
462-736, South Korea
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. DX-D 40G and DR 40C are trademarks 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 2014 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.
4 | DX-D 40C, DX-D 40G | Legal Notice
0290A EN 20140626 1622

Introduction to this Manual
Topics:
•Scope
•Warnings, Cautions, Instructions and Notes
•Disclaimer
DX-D 40C, DX-D 40G | Introduction to this Manual | 5
0290A EN 20140626 1622

Scope
This manual contains information for the safe and effective operation of the
DX-D 40C and DX-D 40G wireless DR Detectors and peripheral equipment,
further referred to as the DR Detector.
Documentation by the manufacturer
For complete safety directions and technical documentation, refer to the
ViVIX-S 1417W User Manual that is delivered with the product.
6 | DX-D 40C, DX-D 40G | Introduction to this Manual
0290A EN 20140626 1622

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.
DX-D 40C, DX-D 40G | Introduction to this Manual | 7
0290A EN 20140626 1622

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.
8 | DX-D 40C, DX-D 40G | Introduction to this Manual
0290A EN 20140626 1622

Introduction to the DR Detector
Topics:
•Intended 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
•Environmental Protection
•Safety Directions
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 9
0290A EN 20140626 1622

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.
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.
10 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622

Configuration
The DR Detector is a component that can be integrated in an X-ray system,
connected to a workstation and to the X-ray generator.
6
1
23
5
4
1. DR Detector
2. DR Detector battery
3. DR Detector battery charger
4. System Control Unit (including a wireless access point)
5. Workstation
6. X-ray generator
Figure 1: DR Detector configuration
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 11
0290A EN 20140626 1622

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.
Water ingress This device does not have protection against ingress of
water.
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.
Non-medical equipment
Following components are classified as non-medical equipment:
• DR Detector battery charger
• System Control Unit
• Workstation
12 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622

Options and Accessories
• DR Detector battery
• DR Detector battery charger
• Handle with screws
• Click-on grid
Recommended grid specifications
Size 14 inch x 17 inch
Ratio 10:1 or 6:1
Line pairs per inch 215
SID range 1 m - 1.8 m
Orientation Longitudinal
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 13
0290A EN 20140626 1622

Operation Controls
Topics:
•DX-D 40C, DX-D 40G
•DR Detector Battery Charger
•System Control Unit
•DR Detector Switch on the NX Workstation
14 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622

DX-D 40C, DX-D 40G



5
13
2
7
6
4
1. DR Detector battery lock lever
Unlock the battery.
2. DR Detector battery
Supplies power to the detector during wireless communication.
3. Antenna of the wireless network adapter
Operation in wireless configuration.
4. Effective imaging area border and center position indication
5. DR Detector connector
Operation in wired configuration.
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. On/off switch
Figure 2: DR Detector operation controls
Related Links
Detector Status Indicators on page 71
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 15
0290A EN 20140626 1622

DR Detector Battery Charger
The battery charger has three slots to insert a battery.
Figure 3: DR Detector Battery Charger
Warning: Do not use the battery charger within the patient’s
vicinity.
Related Links
Safety directions for the power supply on page 53
16 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622

System Control Unit
The System Control Unit is connected to the DR Detector via wireless
network.
12
1. Power switch
2. Status indicator
• Blinking green: starting up
• Green: ready
• Blue: communicating to the detector
Figure 4: System Control Unit (SCU)
Warning: Do not use the System Control Unit within the
patient’s vicinity.
Related Links
Safety directions for the power supply on page 53
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 17
0290A EN 20140626 1622

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
Meaning Full Medium Low Empty
Connection status icon (wifi/
wired)
Meaning Good Low Bad Wired DR Detector
Panel status icon
(blinking)
Meaning Ready Initializing exposure Error Sleep
18 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622

System Documentation
The documentation consists of a User manual (this document) and related
documentation:
• NX User Manual (4420).
• NX Key User Manual (4421).
• NX Getting Started Sheets (4424).
• NX Problem Solving Sheets (4425).
• DX-D DR Detector Calibration Key User Manual (0134).
• DX-D System User Documentation (if applicable).
The documentation shall be kept with the system for easy reference. Technical
documentation is available in the product service documentation which is
available from your local support organization.
Documentation by the manufacturer
For complete safety directions and technical documentation, refer to the
ViVIX-S 1417W User Manual that is delivered with the product.
DX-D 40C, DX-D 40G | Introduction to the DR Detector | 19
0290A EN 20140626 1622

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 previous section of this
manual:
• Intended Use.
• Intended User.
• Safety Directions.
20 | DX-D 40C, DX-D 40G | Introduction to the DR Detector
0290A EN 20140626 1622