AGFA CR 30-X User manual

CR 30-X, CR 30-Xm
5175/200
5175/205
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User Manual
2386I EN 20151020 1518

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to CR 30-X/CR 30-Xm ....................................... 9
Intended Use ........................................................... 10
Intended User ..........................................................10
System Configuration .............................................. 10
Main System Configuration ......................... 11
Configuration with Fast ID ...........................12
Configuration with ID Tablet ....................... 13
Optional System Components ......................14
Equipment Classification ......................................... 15
System Documentation ............................................16
Training ...................................................................17
Product Complaints ................................................. 18
Compatibility ...........................................................19
Compliance ............................................................. 20
General ........................................................21
Safety .......................................................... 21
Laser Safety ................................................. 21
Electromagnetic Compatibility .....................21
Harmonization ............................................ 21
Connectivity ............................................................ 22
Installation .............................................................. 23
Mobile Use Installation ................................ 24
Image quality check after transport ..............25
Product Identification ..............................................27
Labels ...................................................................... 28
General ........................................................29
Safety Instructions for Laser Products .......... 32
Cleaning and Disinfection ........................................33
System components .....................................33
Patient data security ................................................ 34
Maintenance ............................................................35
Preventive Maintenance .............................. 36
Cleaning the optical unit ..............................37
Recurrent safety tests ...............................................39
Environmental protection ........................................40
Safety Directions ......................................................41
General safety instructions ...........................42
Quality Control ........................................................44
Getting started .....................................................................45
Basic Features ..........................................................46
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CR 30-X/CR 30-Xm Features ........................47
Operating Modes ......................................... 48
The User Interface ....................................... 49
Starting the device ...................................................51
Basic Workflow using Fast ID ...................................53
Select a patient and start the exam ...............54
Insert the Cassette in the Digitizer ................55
Identify and Digitize the Image .................... 56
Check the image .......................................... 57
Remove the cassette and insert the next one ....
58
Basic Workflow using ID Tablet ............................... 59
Select a patient and start the exam ...............60
Identify the cassette ..................................... 61
Insert the Cassette in the Digitizer ................62
Digitize the Image ........................................63
Check the image .......................................... 64
Remove the cassette and insert the next one ....
65
Stopping the Device .................................................66
Before Switching Off ....................................67
Switching Off ...............................................68
Operating CR 30-X/CR 30-Xm ............................................. 70
Reading an Emergency Image Plate ......................... 71
Re-erasing an Image Plate ........................................72
Reading the Initialization Data of an Image Plate .....74
Reading the Initialization Data in a Configuration
with Fast ID ................................................. 75
Reading the Initialization Data in a Configuration
with ID Tablet ..............................................77
Troubleshooting ...................................................... 78
Digitizer Remote Display ............................. 79
Troubleshooting Checklist ........................... 80
Removing a Jammed Image Plate ................ 84
Behavior in Case of Power Failure ................86
Technical Data .....................................................................87
Specifications .......................................................... 88
Pixel matrix size .......................................................92
Remarks for HF-emission and immunity .............................. 93
Remarks for HF-emission and immunity .................. 93
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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 30-X/CR 30-Xm, 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 30-X, CR 30-Xm | Legal Notice
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Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
CR 30-X, CR 30-Xm | Introduction to this Manual | 5
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Scope
This manual contains information for safe and effective operation of the
CR 30-XTM and CR 30-XmTM digitizer.
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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 CR 30-X/CR 30-Xm
Topics:
•Intended Use
•Intended User
•System Configuration
•Equipment Classification
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Product Identification
•Labels
•Cleaning and Disinfection
•Patient data security
•Maintenance
•Recurrent safety tests
•Environmental protection
•Safety Directions
•Quality Control
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Intended Use
This digitizer 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.
The CR system is used in a radiological environment by qualified staff to read-
out, process and route static X-ray radiographic images.
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.
System Configuration
Topics:
•Main System Configuration
•Configuration with Fast ID
•Configuration with ID Tablet
•Optional System Components
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Main System Configuration
The system has the following configuration:
• The CR 30-X or CR 30-Xm digitizer, a digitizer for image plates retaining
latent X-ray images. The digitizer accepts one cassette containing one
image plate at a time.
• The NX workstation, either a dedicated CR workstation or two 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 MD4.0T General and CR MD4.0T FLFS.
• For CR 30-Xm additionally: CR MM3.0T Mammo and CR MM3.0T
Extremities.
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Configuration with Fast ID
The digitizer is dedicated to a single workstation, on which the identification
software as well as the image processing software is running. The
identification data are transmitted from the workstation to the digitizer via
DICOM Ethernet. For more information, refer to the workstation’s On-line
Help manuals or contact your local service organization.
1
2
1. Digitizer
2. Control PC
The digitizer must not be connected to any version of the Agfa
ADC QSTM or ADC VIPSTM software.
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Configuration with ID Tablet
Two workstations can serve a shared digitizer, provided that each workstation
has an ID Tablet. There is no physical link required between the workstation
and the digitizer.
In this configuration, a cassette can be identified using any of the
workstations. The patient demographic data and examination data are
entered via the identification software and stored on the RF-tag of the cassette
via the ID Tablet.
The image is sent to the workstation where the cassette has been identified.
The image can not be rerouted to the other workstation.
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Optional System Components
Topics:
•Powerware 5115 UPS
•Full Leg Full Spine Application Components
Powerware 5115 UPS
The system can be extended with the Powerware 5115 uninterruptible power
system (UPS). The UPS is available in two voltage types: 110 V and 230 V.
The Powerware 5115 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 service technician.
With the Powerware 5115, you can safely eliminate the effects of power
disturbances and guard the integrity of your system.
To install the Powerware 5115 UPS into the system, proceed as follows:
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 and the NX workstation into the appropriate UPS output
receptacles.
In case of power failure, the batteries of the UPS supplies power to the
digitizer and the NX workstation.
Full Leg Full Spine Application Components
• CR FLFS Cassette and Plate set (e.g. CR MD4.0T FLFS).
• NX FLFS license (including Stitching software).
• CR Full Body Cassette Holder.
• Anti-scatter grid (optional).
• CR EasyLift (optional).
For more information and instructions on the FLFS application, refer to the
document 4408, CR Full Leg Full Spine User Manual.
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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
outlet.
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
ingress 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.
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System Documentation
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.
For safety precautions on stitching FLFS (Full Leg Full Spine) images, refer to
the “Safety Directions” section of the NX User Manual and the CR Full Leg Full
Spine User Manual.
The user documentation consists of:
• CR 30-X/CR 30-Xm User Documentation CD (digital media)
• NX User Documentation CD (digital media)
The CR 30-X/CR 30-Xm user documentation:
• CR 30-X/CR 30-Xm User Manual, (this document)
• CR 30-X/CR 30-Xm Plates and Cassettes User Manual, document 2387
• Getting Started with the ID Tablet, document 2287
The NX user documentation:
• NX User Manual, document 4420 and NX Key User Manual, document
4421
• CR Full Leg Full Spine User Manual, document 4408
• CR Mammography System User Manual, document 2344
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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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Compliance
Topics:
•General
•Safety
•Laser Safety
•Electromagnetic Compatibility
•Harmonization
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