AGFA DX-G User manual

DX-G, DX-M
5170/100
5170/200
User Manual
2321G EN 20181126 1428

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction .......................................................................... 9
Intended Use ............................................................10
Intended User .......................................................... 10
Configuration .......................................................... 11
System Documentation ............................................12
Training ...................................................................13
Product Complaints ..................................................14
Compatibility ...........................................................15
ADC QS and ADC VIPS Software .................. 15
Compliance ..............................................................16
General ........................................................17
Safety ...........................................................17
Laser Safety ................................................. 17
Electromagnetic Compatibility ..................... 17
Environmental Compliance ..........................17
Equipment Classification ..............................18
Installation .............................................................. 19
Moving the Digitizer .................................... 21
Mobile Use Installation ................................ 24
Locking the digitizer before transport .......... 25
Unlocking the digitizer after transport ......... 28
Image quality check after transport ..............30
Labels ...................................................................... 31
Product Identification ..................................32
General ........................................................33
Cassette handling ........................................ 35
Safety Instructions for Laser Products .......... 36
Maintenance and Cleaning .......................................37
Preventive Maintenance by the Service Engineer
..........................................................................38
Maintenance by the User ..............................38
Recurrent safety tests ...............................................45
Patient data security ................................................ 46
Safety Directions ......................................................47
General Safety Instructions .......................... 49
Quality Control ........................................................ 51
Getting started .....................................................................52
Basic Features ..........................................................53
DX‑G/DX-M Features ................................... 54
Operating Modes ......................................... 55
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The User Interface ................................................... 56
Status Indicator ........................................... 56
Starting the Digitizer ............................................... 58
Basic Workflow (Scanning Images) ..........................60
Stopping the digitizer .............................................. 62
Before Switching Off ....................................63
Switching Off .............................................. 64
Advanced Operation ............................................................ 65
Re-erasing an Image Plate ........................................66
Re-routing of an Image ............................................ 68
Turning the Volume of the Digitizer Signals and Beeps On
or Off .......................................................................71
Changing the Brightness of the Touch Panel .............73
Retrieving Information About the Digitizer .............. 75
Troubleshooting and Errors during Operation ..........76
Status Indicator: continuously red ................77
Status Indicator: flashing red ....................... 78
Digitizer does not Start up ........................... 79
Technical Data .....................................................................80
Specifications .......................................................... 81
Pixel Matrix Size ...................................................... 85
Connectivity ............................................................ 86
Environmental protection ........................................ 87
Remarks for HF-emission and immunity ..................88
Immunity to RF wireless communication
equipment ................................................... 93
Precautions on EMC .....................................94
Cables, transducers and accessories ............. 95
Maintenance on EMC relevant parts .............96
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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-G and DX-M 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 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
4 | DX-G, DX-M | Legal Notice
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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 safe and effective operation of the
DX‑GTM/DX-MTM digitizers.
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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
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Installation
•Labels
•Maintenance and Cleaning
•Recurrent safety tests
•Patient data security
•Safety Directions
•Quality Control
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Intended Use
This device must only be used to scan exposed X-ray cassettes, containing an
erasable image plate (IP). The digitizer is part of a system, consisting of X-ray
cassettes with erasable phosphor image plates and a workstation where the X-
ray cassettes are identified and the resulting digital image information is
further processed and routed. It is intended that this device is only operated in
a radiological environment by qualified staff.
Related Links
Training on page 13
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.
Related Links
Training on page 13
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Configuration
The digitizer is part of a CR system that has the following configuration:
• The digitizer, a digitizer for scan of image plates retaining latent X-ray
images. The digitizer accepts multiple cassettes at a time, to be scanned
sequentially.
• The NX workstation, one or more CR workstations with ID Tablet for
cassette identification, image processing and image transmission of
digitized images received from the digitizer.
• Cassette and plate system: CR HD5.x General, CR HD5.x FLFS, CR HD5.x
AEC, CR HD5.x Extremities, CR MD4.xR General and CR MD4.xR FLFS.
• For DX-M additionally, CR HM5.x Mammo or CR MM3.xR Mammo - mixed
use of both types in one digitizer will not be supported.
• The CR HD5.x General detector, CR HD5.x FLFS detector, CR HD5.x AEC
detector, CR HD5.x Extremities detector, CR MD4.xR General plate and
cassette, CR MD4.xR FLFS plate and cassette, CR HM5.x Mammo detector
and CR MM3.xR Mammo plate and cassette are generically referred to as
‘plates and cassettes’.
Note: The use of CR HD5.0 Extremities cassettes requires a
software version ≥ NIM_2501.
Note: For US DX-M is released in combination with CR HM5.x
Mammo detectors only.
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System Documentation
The documentation consists of following items:
• DX-G and DX-M User Manual.
• DX-G and DX-M Workflow Sheets.
• AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR
HM5.x, CR MM3.xR) User Manual.
• CR Full Leg Full Spine User Manual (4408).
• NX User Manual (4420).
• CR Mammography System User Manual (2344).
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.
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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 representative can provide further information on training.
Related Links
Intended Use on page 10
Intended User on page 10
Safety Directions on page 47
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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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Compatibility
The equipment must only be used in combination with other equipment or
components if these are expressly recognized by Agfa as compatible. A list of
such equipment and components is available from Agfa service on request.
Changes or additions to the equipment must only be carried out by persons
authorized to do so by Agfa. Such changes must comply with best engineering
practices and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 60950 for data processing equipment
or IEC 60601-1 for medical equipment). Furthermore all configurations shall
comply with the requirements for ME systems according to IEC 60601-1.
Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system, and is therefore responsible
that the system complies with the requirements for ME systems according to
IEC 60601-1. If in doubt, consult your local service organization.
ADC QS and ADC VIPS Software
The digitizer must not be connected to any version of the Agfa ADC QS or ADC
VIPS Software.
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Compliance
Topics:
•General
•Safety
•Laser Safety
•Electromagnetic Compatibility
•Environmental Compliance
•Equipment Classification
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General
• 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).
• ISO 13485
• IEC 62366
• IEC 62304
• ISO 14971
Safety
• IEC 60601-1
• UL 60601-1
• AAMI/ANSI ES 60601-1 1st Edition
• CAN/CSA C 22.2 No.60601.1
Laser Safety
• IEC 60825-1
Electromagnetic Compatibility
• IEC 60601-1-2
• FCC Rules 47 CFR part 15 subpart B
• CAN/CSA 22.2 No. 60601-1-2
Environmental Compliance
• WEEE 2012/19/EC
• RoHS 2 Directive 2011/65/EU
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Equipment Classification
This device is classified as following:
Table 1: Equipment classification
Class I equipment Equipment in which protection against electric
shock does not relay on basic insulation only, but
includes a power supply cord with protective earth
conductor. For earth reliability always plug the
main power cord into an earthed mains power out-
let.
Type B equipment Not classified.
The patient does not get in contact with any part of
the equipment.
Water ingress This device does not have protection against in-
gress of water.
Cleaning See section on cleaning and disinfecting.
Disinfection See section on cleaning and disinfecting.
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.
Related Links
Maintenance and Cleaning on page 37
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Installation
CAUTION:
Excessive light falling on the digitizer during operation may
create image artefacts leading to retakes. Do not expose the
digitizer to direct sunlight, max. 2500 Lux.
WARNING:
Do not apply excessive shock or vibration to the digitizer during
operation. This may decrease the image quality. Neither should
the device be moved during operation.
WARNING:
Mechanical shocks or external vibration applied to the digitizer
during mobile use or transport degrades image quality and may
lead to retakes. Take care not to exceed the specified vibration
conditions.
WARNING:
Failure of a protective earth connection can increase the risk of
electric shock. Regularly check the connections of the protective
earth connection of the mains plug. It is recommended to use
and regularly check the second protective earth connector.
WARNING:
Agfa recommends the installation of a UPS (uninterruptible
power supply) for the digitizer to overcome power failures of the
hospital power network and to prevent a resulting image-loss.
Digitizer installation and configuration is performed by an Agfa certified
service engineer.
The digitizer is foreseen to be installed in a stationary and weather protected
location.
In case of an installation in a mobile environment, such as a bus, van, etc, the
manufacturer of the vehicle should ensure that all components of the system
are fixed or can be fixed safely for transport. There is a mobile version of the
digitizer available that provides externally accessible locking systems for the
fixation of the mechanics inside the device.
CAUTION:
The digitizer and the cassette storage shall be protected against
direct radiation in such a way, that the annual dose equivalent
at the place of installation will not exceed 1 mSv/a.
CAUTION:
When installing the digitizer, care must be taken to ensure that
there is either a mains plug or an all-cable disconnecting device
in the internal installation fitted near the digitizer and that it is
easily accessible.
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Topics:
•Moving the Digitizer
•Mobile Use Installation
•Locking the digitizer before transport
•Unlocking the digitizer after transport
•Image quality check after transport
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