AGFA Auto QC2 User manual

Auto QC²
User Manual
2370C EN 20180330 1524

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
About the safety notices in this document .................. 6
Disclaimer ................................................................. 7
Introduction .......................................................................... 8
Intended Use ............................................................. 9
Intended User .......................................................... 10
Training ................................................................... 11
Features ...................................................................12
Compatibility ...........................................................13
Compliance ..............................................................16
Connectivity ............................................................ 17
Installation .............................................................. 18
Product Complaints ................................................. 19
Messages ................................................................. 20
Related Documentation ........................................... 21
Safety Directions ..................................................................22
Auto QC² Hardware Components .........................................23
Filter Module and Filters ..........................................24
Positioning Template ............................................... 27
Test Phantom ........................................................... 31
Light Field Indicator Target ......................................35
Metal Pins ................................................................37
Dosimeter ................................................................38
Operating Auto QC² Software .............................................. 39
Starting Auto QC² Software ..................................... 40
Stopping Auto QC² Software .................................... 41
Switching to Windows without Stopping Auto QC²
Software ..................................................................42
Auto QC² Software Windows ................................... 43
Worklist Window ......................................... 44
History Window ...........................................46
Search Window ............................................47
Main Menu Window .................................... 48
General Workflow ............................................................... 49
Test Group Selection ................................................50
Preparing the Modality and Acquiring an Exposure ....
51
Identifying the Cassette and Sending the Examinations to
the Auto QC² Software Station using NX .................. 53
Managing the Worklist .............................................54
Removing images .........................................57
Editing Image Information ...........................58
Performing the Visual Check ........................60
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Generating the Result, Publishing the Report and
Exporting the Result Data ............................ 67
Managing Reports with the Search Window .........................71
Removing Reports ................................................... 73
Viewing Exposures Connected to the Report ............ 74
Creating a Report .....................................................75
Exporting the Data of a Report .................................76
Closing the List of Search Results ............................. 77
Using the History Function .................................................. 78
Creating a History Report ........................................ 81
Exporting the Data of a Report .................................82
Main Menu .......................................................................... 83
Opening the Online Help ......................................... 84
Checking the Auto QC² Software Version ................. 85
Configuring the DICOM Gateway .............................86
Editing X-Ray Tube information ............................... 87
Adding an X-Ray Tube ..................................88
Updating Settings of an Existing X-Ray Tube ....
90
Removing X-Ray Tubes .................................92
Closing the List of X-Ray Tubes .....................93
Configuring the Monitor .......................................... 94
Importing Images .................................................... 95
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Legal Notice
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. Auto QC² 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:
•About the safety notices in this document
•Disclaimer
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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
•Training
•Features
•Compatibility
•Compliance
•Connectivity
•Installation
•Product Complaints
•Messages
•Related Documentation
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Intended Use
Auto QC² is used for acceptance procedures and quality control tests of
medical CR systems, especially Agfa Digitizers and plates. Auto QC² will be
used in:
• The production of CR systems.
• Acceptance procedures of new installations.
• Quality control procedures performed by the customers.
Table 1: Intended use of Auto QC².
Category Description
Device Type Quality Control Device.
Role of the Device Quality Control.
Environment of use • In X-ray rooms.
• Outside X-ray rooms.
• Private radiologist sites.
• Clinics.
• Imaging centers.
• Emergency rooms.
• Intensive care sites.
• Mobile environments.
Medical area • General Radiology (GenRad).
• Pediatrics.
• Uro/Tomo.
• Dental.
• Radiotherapy (only for acceptance procedures by
Agfa Service personnel).
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Intended User
Performing Auto QC² examinations mainly needs two competences in the
hospital test area:
• Using all the Auto QC² hardware components (positioning template,
phantom, filter module, Light Field Indicator target), setting up the test
installations and performing the test exposures.
• Interpreting and analyzing the results using Auto QC² software and take
corrective actions if necessary.
It is the responsibility of the hospital management to assign these
competences to the most appropriate persons.
In general following users can be expected:
• In the medical environment: hospital physicists, imaging specialists,
radiographers or service engineers performing acceptance tests and
quality control tests.
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Training
The user must have received adequate training on the safe and effective use of
Auto QC² before attempting to work with it. Training requirements may vary
from country to country. 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.
The user must note the following information in the preliminary section of
this manual:
Related Links
Intended Use on page 9
Intended User on page 10
Safety Directions on page 22
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Features
Auto QC² is developed as a tool to check quality aspects related to the
radiology practice.
The concepts used for quality control with Auto QC² are defined using the
AAPM Report of Task Group 10 (Acceptance Testing and Quality Control for
photostimulable storage phosphor imaging systems) as a guideline.
In this perspective, Auto QC² has the following features:
• One phantom is used for spatial and contrast tests.
• Auto QC² Software offers an easy user interface, enabling the user to
perform the steps and to interpret and analyze the results.
• Auto QC² generates test results with acceptance levels.
• Auto QC² generates a report of the test results.
• Auto QC² offers search and history functions.
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Compatibility
• Compatibility with Agfa equipment:
Table 2: Compatibility with Agfa equipment.
Equipment Type
Digitizers: Auto QC² is compatible with the following Digitizers.
• ADC COMPACT
• ADC COMPACT PLUS V1.1
• ADC COMPACT PLUS
• CR 25
• DX-S
• CR 75
• CR 85
• CR 30
• CR 35
• CR 55
• CR 55 ASAP
• DX-G
• DX-G ASAP
• CR 30
• DX-M
• DX-M ASAP
• CR30-X
• CR30-Xm
• CR10-X
• CR12-X
• CR15-X
• CR15-X-CROP
• Fast ID is not supported for the DICOM Digitizers (ADC
Solo, ADC Compact, ADC Compact Plus, CR 25, CR 35-X,
CR 75, CR 85-X, DX-G and DX-M) for scanning the
cassettes with quality control exposures, as high
resolution images are required for quality control
procedures.
• Fast ID for identifying the cassettes is supported for the
DX-S and CR 30-X Digitizer, in the sense that for these
digitizer types this is the only way to identify cassettes
without ID Tablet.
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Equipment Type
• DX-S does not support to be connected to a Windows 10
pc, but the images can be sent from the DX-S pc to Auto
QC² running on a standalone Windows 10 pc.
Cassette
sizes:
• 15x30 cm.
• 18x 24 cm.
• 8x10 inch.
• 24x30 cm.
• 10x12 inch.
• 35x43 cm (PQC/ATP/LFI).
• 35x35 cm.
Plate types: • ADC MD 10.
• CR MD 30.
• CR MD 40.
• CR MD 4.0.
• CR MD 4.0R.
• CR HD 5.0.
• CR MD1.0 General
• CR HD5.0S General
• Software compatibility:
Table 3: Compatibility with Agfa equipment.
Equipment Type
Browser requirements: • Internet Explorer version 5.0 or higher.
Operating Systems: Auto QC² version 1.00:
• Windows XP Home SP2.
• Windows XP Professional SP2.
• Windows Vista SP1 - 32 bit.
• Windows 7 - 32 bit.
Auto QC² version 2.00:
• Windows 10 - 64 bit.
• Older versions of Windows are not supported.
Microsoft Excel: • Excel 2000 or higher.
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• Hardware compatibility:
Table 4: Supported hardware.
Item Type
Processors: Only support for the following Windows XP 32-bit Intel
processors:
• Intel: Pentium 4 (or higher)
• AMD: Athlon 64 (or higher)
Supported
screen
resolutions:
Auto QC² Software will support the following
resolutions:
• minimum 1280 x 768 pixels.
The recommended Windows display DPI setting is 96.
Auto QC² Software will not start when the screen
resolution does not meet the specifications. The system
will show an error message and stops the initialization of
the Auto QC² Software.
Supported color
quality:
The graphic board must support 32 bits colors.
• X-ray tube collimator compatibility
Check if external DAP with rail is present. Check if it can carry the weight of
the filter module (+/- 2.5 kg)
Note:
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 practice and all applicable laws and
regulations that have the force of law within the jurisdiction of the
hospital.
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Compliance
Auto QC² has been designed in accordance with the MEDDEV Guidelines
relating to the application of Medical Devices and has been tested as part of
the conformity assessment procedures required by 93/42/EEC MDD
(European Council Directive 93/42/EEC on Medical Devices).
This Agfa product has been designed in accordance with the IEC 60601-1, Ed.
3: Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
Auto QC² is compliant with the IEC 61267 standard for Medical Diagnostic X-
Ray Equipment and Radiation conditions for use in the determination of
characteristics.
The concepts used for quality control with Auto QC² are defined using the
AAPM Report of Task Group 10 (Acceptance Testing and Quality Control for
photostimulable storage phosphor imaging systems) as a guideline.
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Connectivity
The Auto QC² workstation requires a 100 Mbit ethernet network to exchange
information with a number of other devices. Auto QC² is provided with a
mechanism to prevent data loss on network failure.
Auto QC² communicates with other devices in the hospital network using the
DICOM protocol with the following SOP Class:
• DICOM
Table 5: DICOM mapping table.
SOP Class SCU/SCP
Digital X-Ray Image Storage – For Processing SCU / SCP
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Installation
Installing Auto QC² Software is done by Agfa Service.
The availability of the Auto QC² software depends on the license dongle to be
connected to the PC. Agfa advizes not to remove the dongle, even if the
Auto QC² software is not being used, because this will consume the “license
grace period”. The grace period is a limited period of time during which you
can continue working if the dongle is accidentaly removed or lost.
To remove the dongle without consuming this license grace period, open the
License Manager tool (Start > Agfa > Service > License Manager) and click
“Disable grace functionality”. This may be useful if Auto QC² is installed on a
laptop, used for other purposes. To use Auto QC², the dongle must be plugged
in. If the dongle gets broken or lost, the licenses will be immediately blocked
and you must open the License Manager tool and click “Enable grace
functionality” to continue working for a limited period of time, during which
the dongle can be replaced.
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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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Messages
Under certain conditions Auto QC² Software will show a dialog box in the
middle of the screen containing a message. This message will tell 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 Agfa service organization.
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