AGFA CR HD5 Series User manual

AGFA CR Detectors, Plates and
Cassettes (CR HD5.x, CR
MD4.xR, CR HM5.x, CR
MM3.xR)
User Manual
2322D EN 20180409 1008

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope of this Manual ..................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to the AGFA CR Detectors, Plates and Cassettes ....
9
Intended Use ............................................................10
Specific Application: Full Leg Full Spine .......11
Specific Application: CR Mammography ...... 12
Specific Application: AEC - cassettes without
backscatter protection ..................................13
Intended User .......................................................... 14
Configuration .......................................................... 15
System Documentation ............................................16
Product Complaints ................................................. 17
Compatibility ...........................................................18
Installation .............................................................. 19
IP Gain Calibration .......................................19
Environmental Protection ........................................ 21
CR Plate .......................................................22
CR Cassette ..................................................23
Safety Directions ......................................................24
Quality Control ............................................25
Description of the AGFA CR Detectors, Plates and Cassettes ....
26
Description of the CR HD5.x General Detector and CR
HD5.x FLFS Detector ................................................27
Description of CR MD4.xR Plate and Cassette .......... 29
Specific Application: Description of CR Full Leg Full Spine
(FLFS) cassette ........................................................ 31
Specific Application: Description of the CR HD5.x AEC
Detector ...................................................................33
Description of CR HM5.x Mammo Detector ..............35
Description of CR MM3.xR Plate and Cassette ..........38
Special Application: Description of CR Mammo Cassette
......................................................................................41
Handling the AGFA CR Detectors, Plates and Cassettes .........42
First Use and Normal Operation ...............................43
Orientation of CR Detectors and CR Plates and
Cassettes ......................................................44
Maximum Cassette Load .............................. 46
Storage and Transport ..............................................47
Operation Conditions .............................................. 48
Cleaning .................................................................. 49
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Contents
2322D EN 20180409 1008

Cleaning Image Plates of the CR Detectors, Plates
and Cassettes ...............................................50
Cleaning the Cassettes of the CR Detectors, Plates
and Cassettes ............................................... 54
Cleaning the Interior of the Mammo Cassette ...
55
Disinfecting the Cassettes ........................................ 58
Approved disinfectants ................................ 59
Use of protective plastic envelope .................59
Safety directions for disinfection .................. 60
Technical Specifications .......................................................61
AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Contents | iii
2322D EN 20180409 1008

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 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Legal Notice
2322D EN 20180409 1008

Introduction to this Manual
Topics:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Introduction to this Manual | 5
2322D EN 20180409 1008

Scope of this Manual
This manual contains information for safe and effective operation of the AGFA
CR Detectors, Plates and Cassettes: the CR HD5.x General/FLFS/AEC
detector, the CR HM5.x Mammo detector, the CR MD4.xR General/FLFS plate
and cassette and the CR MM3.xR Mammo plate and cassette.
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Introduction to this Manual
2322D EN 20180409 1008

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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2322D EN 20180409 1008

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.
8 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Introduction to this Manual
2322D EN 20180409 1008

Introduction to the AGFA CR Detectors,
Plates and Cassettes
Topics:
•Intended Use
•Intended User
•Configuration
•System Documentation
•Product Complaints
•Compatibility
•Installation
•Environmental Protection
•Safety Directions
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2322D EN 20180409 1008

Intended Use
The AGFA CR detectors, plates and cassettes are a part of a system, consisting
of a digitizer and a workstation. The AGFA CR detectors or plates and cassettes
are identified on the workstation. The exposed AGFA CR detectors or plates
and cassettes will be scanned by the digitizer. The resulting digital image is
further processed and routed by the workstation. It is intended that these
devices are only operated in a radiological environment by qualified staff.
The CR HD5.x General detector and the CR MD4.xR plate and cassette are
specifically designed for general radiography applications.
Topics:
•Specific Application: Full Leg Full Spine
•Specific Application: CR Mammography
•Specific Application: AEC - cassettes without backscatter protection
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Introduction to the AGFA CR Detectors, Plates and Cassettes
2322D EN 20180409 1008

Specific Application: Full Leg Full Spine
CR HD5.x FLFS detectors and CR MD4.xR FLFS cassettes are specifically
designed for Full Leg Full Spine application, but can also be used for general
radiography applications.
CR HD5.x FLFS detectors and CR MD4.xR FLFS cassettes are to be used as
described in the CR Full Leg Full Spine User Manual, document 4408.
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2322D EN 20180409 1008

Specific Application: CR Mammography
CR HM5.x Mammo detectors or MM3.xR cassettes and plates are part of the
Mammography System. Mixed use of both types in one system is not
supported. The CR Mammography System can be used in a safe and effective
way for diagnostic mammography and for screening mammography, in
compliance with local regulations. For more information, refer to the CR
Mammography System User Manual, document 2344.
CR HM5.x Mammo detectors can be delivered with an IP Gain Calibration CD.
The contents of this CD (the IP gain calibration file) have to be uploaded to
the NX workstation prior to use. The IP gain calibration file can only be used
with the plate or detector it has been delivered with.
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Introduction to the AGFA CR Detectors, Plates and Cassettes
2322D EN 20180409 1008

Specific Application: AEC - cassettes without backscatter
protection
It is intended to use the CR HD5.x AEC Detectors for general radiography
applications only in combination with X-ray modalities, with an AEC system
(Automatic Exposure Control) positioned behind the cassette as this is the
case for e.g. specific trauma- or pediatric X-ray modalities.
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2322D EN 20180409 1008

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.
14 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Introduction to the AGFA CR Detectors, Plates and Cassettes
2322D EN 20180409 1008

Configuration
The different detector, plate and cassette types are :
• CR HD5.x General detector
• CR HD5.x FLFS detector
• CR HM5.x Mammo detector
• CR HD5.x AEC detector
• CR MD4.xR General plate and cassette
• CR MD4.xR FLFS cassette
• CR MM3.xR Mammo plate and cassette
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2322D EN 20180409 1008

System Documentation
The documentation consists of following items:
• DX-G/DX-M User Manual (2321).
• DX-G/DX-M Workflow Sheets (2323).
• AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR
HM5.x, CR MM3.xR) User Manual (2322, this document).
• CR Mammography System User Manual (2344).
• CR Full Leg Full Spine User Manual (4408).
• NX User Manual (4420).
• CR HM5.x User Documentation - IP Gain Calibration CD.
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.
16 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Introduction to the AGFA CR Detectors, Plates and Cassettes
2322D EN 20180409 1008

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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2322D EN 20180409 1008

Compatibility
The use of CR HM5.x Mammo detectors is restricted by compatibility criteria
specified in the table below, depending on the availability of an IP gain
calibration file.
There are two valid system configurations. If one component is upgraded or
replaced, all other components must be upgraded or replaced to fit the new
configuration.
Table 1: Compatibility of CR HM5.x Mammo detectors with the NX software
Configuration 1
NX software Version NX 2.0.8500/3.0.8500 or older
CR HM5.x Mammo
detector
Without IP gain calibration file
Configuration 2
NX software Version NX 2.0.8500/3.0.8500 SU1 or newer. For
plates or detectors that are delivered with an IP gain
calibration file, the IP gain calibration files must be
loaded on the NX workstation.
CR HM5.x Mammo
detector
With or without IP gain calibration file
How to retrieve the version number of the NX software is described in the NX
User Manual.
18 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
Introduction to the AGFA CR Detectors, Plates and Cassettes
2322D EN 20180409 1008

Installation
The CR HD5.x detectors and the CR MD4.xR plates and cassettes are factory
predefined. No further configuration is required from customer side to use
them with the digitizer.
The cassettes have to be erased before first use, as described later in this
document.
Topics:
•IP Gain Calibration
IP Gain Calibration
For CR HM5.x Mammo detectors that are delivered with an IP Gain
Calibration CD, the IP gain calibration file has to be installed on the NX
workstation prior to first use. The installation is performed by Agfa certified
service personnel.
To replace a plate or detector or introduce a new plate or detector to the
system without a certified Agfa service engineer being present, the IP gain
calibration file has to be uploaded by the end-user.
Problem Solving
Table 2: Uploading the gain calibration file
Problem A plate or detector is replaced or a new plate or detector is intro-
duced to the system without a certified Agfa service engineer
being present.
Solution The IP gain calibration file has to be uploaded by the end-user.
Procedure Follow the instructions on the IP Gain Calibration CD sleeve.
The IP gain calibration file is automatically distributed to other
NX workstations in the network.
Table 3: Checking whether a gain calibration file is required
Prob-
lem
It is not known if a plate or detector requires an IP gain calibration
file.
Solu-
tion
If it is not clear if the plate or detector has been delivered with an IP
gain calibration file, check on the NX workstation if the plate or de-
tector requires an IP gain calibration file.
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2322D EN 20180409 1008

Proce-
dure
1. On the NX workstation, click Read and Initialize Cassette in the
Functionality Overview pane of the Main Menu window.
2. Insert a cassette in the ID Tablet.
3. Click Read.
The Read and Initialize Cassette pane shows the details of the in-
serted cassette.
On NX 2.0.8500/3.0.8500 or newer, the field “IP Gain Calibration”
specifies if the plate or detector requires a gain calibration file.
On NX 2.0.8400/3.0.8400 or older, an error is displayed in case the
plate or detector requires a gain calibration file (“The cassette is
not initialized (properly)”). The plate or detector can only be used
after upgrade of the NX software.
Table 4: Finding the right gain calibration file
Problem It is not clear which IP gain calibration CD belongs to which
plate or detector.
Solution Match the identification values.
Procedure 1. Read the RF tag on the plate or detector. The field “Identifi-
cation” contains the plate identification.
2. Check whether the “Identification” on the label of the CD
corresponds with the plate identification.
20 | AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) |
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2322D EN 20180409 1008