AGFA DX-D 10C User manual

DX-D 10C, DX-D 10G, DX-D 20C,
DX-D 20G
User Manual
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Contents
Legal Notice ..........................................................................3
Introduction to this Manual ................................................... 4
Scope of this Manual ..................................................5
About the safety notices in this document .................. 6
Disclaimer ................................................................. 7
Introduction .......................................................................... 8
Intended Use ............................................................. 9
Intended User ............................................................9
Configuration ............................................................ 9
Operation Controls .................................................... 9
System Documentation ............................................10
Product Complaints ................................................. 11
Compliance ..............................................................12
Connectivity ............................................................ 13
Messages ..................................................................14
Labels ...................................................................... 15
Cleaning and Disinfecting ........................................ 16
Cleaning ...................................................... 17
Use of protective plastic bag ......................... 18
Disinfecting ..................................................19
Approved disinfectants ................................ 20
Maintenance ............................................................21
Environmental protection ........................................ 22
Safety Directions ..................................................................23
Limitations for patient contact ................................. 25
Basic Workflow ....................................................................26
Starting the DR Detector .......................................... 27
Attaching the Grid ................................................... 28
Positioning the DR Detector ..................................... 29
Executing the Exposure ............................................33
Stopping the DR Detector .........................................34
Problem solving ...................................................................35
DR Detector must be recalibrated .............................36
DR Detector Problem ............................................... 36
Technical Data ..................................................................... 37
DR Detector Technical Data ......................................37
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Legal Notice
0086
Manufactured by Varex Imaging for Agfa NV
Varex Imaging Corporation, 1678 So. Pioneer Rd, Salt Lake City, UT 84104,
USA
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 is a trademark 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 2018 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
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Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
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Scope of this Manual
This manual contains information for safe and effective operation of the DX-D
10G, DX-D 10C, DX-D 20G and DX-D 20C portable DR Detector, 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
Topics:
•Intended Use
•Intended User
•Configuration
•Operation Controls
•System Documentation
•Product Complaints
•Compliance
•Connectivity
•Messages
•Labels
•Cleaning and Disinfecting
•Maintenance
•Environmental protection
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Intended Use
The DR Detector is a 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.
Intended User
This manual has been written for trained users of Agfa products and trained
diagnostic X–Ray clinical personnel who have received proper training.
Users are those persons who actually handle the equipment and those who
have 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.
Configuration
The DR Detector is a component that can be integrated in an X-ray system,
connected to an NX workstation and to the X-ray generator through the X-Ray
Device Integration (XRDI) software.
Operation Controls
The DR Detector is controlled via the NX workstation and via the DR Detector
control unit.
The DR Detector control unit has a switch to power the DR Detector on and
off.
The DR Detector control unit has indicator lights that reflect the status of the
DR Detector.
Note: Depending on the integration, the DR Detector control
unit may not be available to the user.
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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.
The most extensive configuration is described within this manual, including
the maximum number of options and accessories. Not every function, option
or accessory described may have been purchased or licensed on a particular
piece of equipment.
Technical documentation is available in the product service documentation
which is available from your local support organization.
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
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Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify
Agfa.
If the device malfunctions and may have caused or contributed to a serious
injury, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax [phone]
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Compliance
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
• IEC 60601-1 2nd edition
• IEC 60601-1-2 2nd edition
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Connectivity
The DR Detector is connected to the control unit. The DR Detector’s control
unit is connected to the mains power, to the NX workstation and to the X-ray
generator.
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Messages
Under certain conditions the system shows a dialog box in the middle of the
screen containing a message, or a message is displayed in a fixed message area
in the user interface. This message informs the user that either a problem has
occurred or that a requested action cannot be performed. The user must read
these messages carefully. It will provide information on what to do from then
on. This will be either performing an action to resolve the problem or to
contact the service organization. Details on the contents of messages can be
found in the service documentation which is available to service personnel.
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Labels
Symbol Explanation
On (power: connection to the mains)
Off (power: disconnection from the mains)
Tube side
Direct current
Alternating current
Protective earth (ground)
This mark indicates that this is a Type B Equipment
Handle with care
Maximum patient weight
Patient orientation mark
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Cleaning and Disinfecting
All appropriate policies and procedures should be followed to avoid
contamination of the staff, patients and equipment. All existing universal
precautions should be extended to avoid potential contaminations and to
avoid patients coming into (close) contact with the device. The user is
responsible for selecting a disinfection procedure.
Topics:
•Cleaning
•Use of protective plastic bag
•Disinfecting
•Approved disinfectants
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Cleaning
To clean the exterior of the equipment:
1. Stop the system
WARNING:
When the equipment is going to be cleaned, be sure to turn
OFF the power of each device, and to unplug the power cord
from the AC outlet. Never use anhydrous or high solvency
alcohols, benzine, thinner or any other flammable cleaning
agent. Otherwise, it may result in fire or electric shock.
2. Wipe the exterior of the system with a cloth slightly moistened with a
neutral detergent. Some approved disinfectants can be used for cleaning
as well.
CAUTION:
Make sure no liquid gets in the device.
CAUTION:
Clean the equipment with only a little moisture. Do not
spray disinfectants or detergents directly on the equipment.
Do not pour liquid directly on the equipment.
CAUTION:
Do not use solvents such as anhydrous or high solvency
alcohols, thinner or benzine. Do not use any corrosive,
dissolving or abrasive cleaning or polishing detergents.
Doing so may damage the surface of the equipment. Using
unsuitable cleaning agents or methods can damage the
property when surface becomes dull and brittle (e.g. by
using alcohol-containing agents).
Note: Do not open the equipment for cleaning. No
components inside the device require cleaning by the user.
3. Start up the system.
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Use of protective plastic bag
WARNING:
Liquids ingressing the DR Detector may cause malfunction and
contamination.
If there is a chance that the detector comes in contact with liquids (bodily
fluids, disinfectants,...), the DR Detector must be wrapped in a protective
plastic bag while performing the examination.
It is considered good clinical practice to use a single-use protective bag in all
cases where contact of the device or contaminants is expected, to avoid
contamination of others.
Make sure that the plastic bag is not wrinkled to avoid the creases showing in
the image.
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Disinfecting
To disinfect the device, use only disinfectants and disinfection methods that
are approved by Agfa and that correspond to the national regulation and
guidelines as well as explosion protection. If you plan to use other
disinfectants, approval of Agfa is needed before use, as most disinfectants can
damage the device. UV disinfection is also not allowed.
Perform the procedure following the instructions for use, the disposal
instructions and the safety instructions of the selected disinfectants and tools
and of the hospital.
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Approved disinfectants
Refer to the Agfa website for specifications on the disinfectants that have been
found compatible with the cover material of the device and can be used on the
outer surface of the device.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138
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