AGFA CR 10-X User manual

CR 10-X, CR 12-X, CR 15-X
5151/100
5151/200
5151/300
User Manual
CR10-X
CR12-X
CR15-X
2491E EN 20150409 1543

Contents
Legal Notice ..........................................................................4
Introduction .......................................................................... 5
Introduction to this Manual ....................................... 6
Scope .............................................................7
About the safety notices in this document ...... 8
Disclaimer ..................................................... 9
Introduction to CR 10-X, CR 12-X and CR 15-X .......... 9
Intended Use ............................................... 10
Indications for Use .......................................11
Intended User .............................................. 12
Configuration .............................................. 13
Operation Controls ...................................... 15
System Documentation ................................17
Training .......................................................18
Product Complaints ..................................... 19
Compatibility ...............................................20
Compliance ................................................. 21
Connectivity ................................................ 23
Installation .................................................. 24
Labels .......................................................... 26
Cleaning and Disinfection ............................29
Patient data security .................................... 30
Maintenance ................................................31
Recurrent safety tests ...................................32
Environmental protection ............................ 33
Safety Directions ..........................................34
Quality Control ............................................37
Getting started .....................................................................38
Starting the Digitizer ............................................... 39
Basic Workflow ........................................................40
Step 1: Select a patient and start the exam ... 41
Step 2: Digitize the image ............................ 42
Step 3: Perform a quality control ..................45
Step 4: Remove the cassette and insert the next
one .............................................................. 46
Stopping the Device .................................................47
Before Switching Off ....................................48
Switching Off ...............................................49
Operating CR 10-X, CR 12-X and CR 15-X ............................ 50
Reading an Emergency Image Plate ......................... 51
Re-erasing an Image Plate ........................................52
Reading the Initialization Data of an Image Plate .....54
Expiry of Image Plates ..............................................57
Upcoming Expiry of the Image Plate ............ 58
Expired Image Plate .....................................58
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Troubleshooting ...................................................... 59
Digitizer Remote Display ............................. 60
Connection Problems ...................................61
Cassette Could Not Be Identified ..................62
Cassette release button pressed before end of cycle
..........................................................................63
Cannot read data on the image plate ............64
Image Plate Transport Problems .................. 65
Removing a Jammed Image Plate ................ 66
Behavior in Case of Power Failure ................70
Cleaning the Optical Unit .............................71
Technical Data .....................................................................73
Specifications .......................................................... 74
Cassette formats ...................................................... 78
Remarks for HF-emission and immunity .............................. 79
Remarks for HF-emission and immunity .................. 79
CR 10-X, CR 12-X, CR 15-X | Contents | 3
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Legal Notice
0413
Agfa HealthCare NV, Septestraat 27, B-2640 Mortsel - Belgium
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. CR 10-X, CR 12-X, CR 15-X, NX, ADC QS and ADC VIPS 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 2015 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 | CR 10-X, CR 12-X, CR 15-X | Legal Notice
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Introduction
Topics:
•Introduction to this Manual
•Introduction to CR 10-X, CR 12-X and CR 15-X
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Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
6 | CR 10-X, CR 12-X, CR 15-X | Introduction
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Scope
This manual contains information for safe and effective operation of the
CR 10-XTM, CR 12-XTM and CR 15-XTM digitizers, further referred to as the
digitizer, unless the information applies to a specific type.
CR 10-X, CR 12-X, CR 15-X | Introduction | 7
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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.
Safety icons
The purpose of safety icons is to indicate at a glance the type of caution,
warning or danger.
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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.
Caution: In the United States, Federal law restricts this device to
sale by or on the order of a physician.
Introduction to CR 10-X, CR 12-X and CR 15-X
Topics:
•Intended Use
•Indications for Use
•Intended User
•Configuration
•Operation Controls
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Labels
•Cleaning and Disinfection
•Patient data security
•Maintenance
•Recurrent safety tests
•Environmental protection
•Safety Directions
•Quality Control
CR 10-X, CR 12-X, CR 15-X | Introduction | 9
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Intended Use
The digitizer is part of a CR system, further containing a cassette, image plate
and modality workstation. The CR system is used in a radiological
environment by qualified staff to read-out, process and route static X-ray
radiographic images.
The cassette is used to protect the image plate from light and damages during
X-ray exposure, transport and handling.
The image plate is used to capture the static X-ray radiographic images; the
image plate is scanned by the digitizer.
The digitizer is used to scan an X-ray exposed image plate; it results into a
digital image which is sent to the dedicated workstation.
The modality workstation is used to process and route the digital images from
the digitizer.
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Indications for Use
Agfa’s Computed Radiography (CR) System with CR 10-X, CR 12-X or CR 15-X
digitizer is indicated for use in general projection radiographic applications to
capture for display diagnostic quality radiographic images of human anatomy.
The system may be used wherever conventional screen film systems are used.
Agfa’s Computed Radiography (CR) System with CR 10-X, CR 12-X or CR 15-X
digitizer is not indicated for use in mammography.
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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.
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Configuration
The system consists of:
• the digitizer for scanning image plates retaining latent X-ray images. The
digitizer accepts one cassette containing one image plate at a time.
• cassette and plate system:
• CR MD1.0 General
• CR MD1.0F General
• CR DD1.0 Vet
• CR HD5.0S Genrad (CR 15-X only)
The digitizer can be used in combination with:
• the NX workstation, a CR workstation for image acquisition, identification,
image processing and image transmission of digitized images received
from the digitizer.
• UPS (optional): the uninterruptible power system (UPS) protects the PC
when the main power supply has crashed, and avoids the loss of images.
UPS configuration requires special software. This software will be
installed and configured by an Agfa trained service technician.
1
2
1. Digitizer
2. Control PC
Topics:
•To install the UPS into the system
•Full Leg Full Spine Application Components
•Cassette adapter
To install the UPS into the system
To install the UPS into the system:
1. Plug the UPS power cord into the input connector at the UPS rear panel.
2. Plug the other side of the UPS power cord into a power outlet.
3. Plug the digitizer, NX workstation and monitor into the appropriate UPS
output receptacles.
CR 10-X, CR 12-X, CR 15-X | Introduction | 13
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In case of power failure, the batteries of the UPS supply power to the
digitizer, the NX workstation and monitor.
Full Leg Full Spine Application Components
• CR Full Body Cassette Holder
• Anti-scatter grid (optional)
• CR EasyLiftTM (optional)
For more information and instructions on the FLFS application, refer to the
document 4408, “CR Full Leg Full Spine User Manual”.
Cassette adapter
The cassette adapter is required for using a 24 cm x 30 cm cassette, depending
on the digitizer model.
Figure 1: Cassette adapter
Related Links
Cassette formats on page 78
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Operation Controls
The digitizer interfaces with the user via:
• a power button,
• an erase button,
• a status indicator,
• a cassette release button.
1
2
4
3
1. Power button
2. Erase button
3. Status indicator
4. Cassette release button
Topics:
•The Erase Button
•Status Indicator
The Erase Button
Press the erase button to start the erasing cycle of an image plate. After
pressing the erase button, the status indicator is continuously lighting up in
blue and the digitizer starts erasing the image plate of the cassette inserted
next. If no cassette with image plate has been inserted after 60 seconds, the
system automatically returns to standby mode.
Related Links
Re-erasing an Image Plate on page 52
Status Indicator
The indicator informs the user by light signals about the status of the digitizer.
It is positioned at the front of the digitizer, so that it is visible from a distance.
Color Constant/
Blinking
Status Action
Blue Constant Activating the
erasing cycle
Insert cassette to erase
the image plate.
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Color Constant/
Blinking
Status Action
Blinking Busy with erasing
and return of the IP
into cassette
Wait.
Green Constant Standby mode
(Ready)
Cassette is ready
for removal
Proceed.
Remove cassette.
Yellow Blinking Busy with
scanning, erasing
and return of the IP
into cassette
Wait.
Red Constant Error Consult the Digitizer
Remote Display UI (User
Interface) messages on
the control PC. Refer to
section
‘Troubleshooting’.
Blinking slowly Digitizer not ready
Blinking fast Digitizer not
connected to
Digitizer Remote
Display UI
Refer to section
‘Troubleshooting’.
Blinking - 3
pulses
Digitizer not
connected to
control PC
Related Links
Troubleshooting on page 59
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System Documentation
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.
The user documentation consists of:
• CR 10-X, CR 12-X, CR 15-X User Documentation CD (digital media).
• NX User Documentation CD (digital media).
The CR 10-X, CR 12-X, CR 15-X User Documentation CD contains:
• CR 10-X, CR 12-X, CR 15-X User Manual (this document), document
2491.
• AGFA CR Plates and Cassettes User Manual, document 2492.
• Getting started with CR 10-X, CR 12-X and CR 15-X, document 2493.
The NX User Documentation CD contains:
• NX user documentation
• CR Full Leg Full Spine User Manual, document 4408.
• Getting Started with NX, document 4417.
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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 or dealer representative can provide further information on
training.
The user must note the following information in the system documentation:
• Intended Use.
• Intended User.
• Safety Directions.
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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.
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