AGFA CR 30-X User manual

CR 30-X/CR 30-Xm Plates and
Cassettes
CR MD4.0T GENERAL SET
CR MD4.0T FLFS SET
CR MM3.0T MAMMO SET
CR MM3.0T EXTREMITIES SET
User Manual
2387E EN 20180416 1238

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to Agfa CR Plates and Cassettes ......................... 9
Intended Use ............................................................10
Intended User .......................................................... 11
Product Complaints ................................................. 12
System Documentation ............................................13
Environmental Protection ........................................ 14
CR Plate .......................................................15
CR Cassette ..................................................16
Installation .............................................................. 17
Safety Directions ......................................................18
General Safety Instructions .......................... 19
Fire Hazard and Extinguishing Media .......... 20
CR 30-X/CR 30-Xm Plates and Cassettes Description ............21
Description .............................................................. 22
Description of the MD 4.xT Cassettes ........... 23
Description of the CR MM 3.xT Mammo Cassette
..........................................................................26
Description of the CR MM 3.xT Extremities
Cassette ....................................................... 28
Description of the CR MD 4.xT and MM 3.xT Tray
and Image Plate ........................................... 29
Orientation of CR Plates and Cassettes .........30
Initialization ............................................................ 31
Initializing Cassette, Tray and Image Plate ... 32
Replacement Image Plates ........................... 33
Precautionary Measures ...........................................33
First Use and Normal Operation ...................34
Maximum Cassette Load ..............................35
Transport .....................................................36
Storage ........................................................ 37
Handling the Tray and Image Plate .............. 38
Cleaning ..............................................................................39
Cleaning the Tray and Image Plate ...........................40
When to clean the tray and image plate? ...... 41
Permitted cleaning products? .......................42
How to clean the tray and image plate? ........43
Cleaning the Cassette ...............................................46
Disinfecting the Cassettes of the CR Detectors, Plates and
cassettes .................................................................. 47
Approved disinfectants ................................ 48
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Use of protective plastic envelope .................48
Safety directions for disinfection ..................49
Cleaning the Interior of a Mammo Cassette ..............50
Specifications ...................................................................... 54
CR 30-X/CR 30-Xm Plates and Cassettes | Contents | iii
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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. CR 30-X/CR 30-Xm, NX, ADC QS and ADC VIPS 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 | CR 30-X/CR 30-Xm Plates and Cassettes | 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 Plates and Cassettes | Introduction to this Manual | 5
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Scope
This manual contains information for safe and effective operation of the CR
MD 4.xT and CR MM 3.xT Plates and CassettesTM.
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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 Agfa CR Plates and
Cassettes
Topics:
•Intended Use
•Intended User
•Product Complaints
•System Documentation
•Environmental Protection
•Installation
•Safety Directions
CR 30-X/CR 30-Xm Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 9
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Intended Use
The AGFA CR plates and cassettes are part of a system, consisting of a digitizer
and a workstation. The AGFA CR plates and cassettes are identified on the
workstation. The exposed AGFA CR 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 MD4.xT General plate and cassette are specifically designed for
general radiography applications.
CR MD4.xT FLFS cassettes are specifically designed for the Full Leg Full Spine
application, but can also be used for general radiography applications.
CR MM3.xT Extremities plates and cassettes are specifically designed for
extremities examinations.
CR MM3.xT Mammo cassettes and plates are part of the Mammography
System, that can be used for diagnostic mammography and for screening
mammography, in compliance with the local regulations. For more
information refer to the CR Mammography System User Manual, document
2344.
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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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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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System Documentation
The documentation shall be kept with the system for easy reference.
For information and safety notes on the CR 30-X/CR 30-Xm System, refer to
the CR 30-X/CR 30-Xm User Manual, document 2386.
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Environmental Protection
Topics:
•CR Plate
•CR Cassette
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CR Plate
Regulations about waste disposal may differ from one country to another.
Please consult local regulations on the subject matter.
At the end of its life cycle, the CR Plate is considered as industrial waste in
most countries.
Consequently it is not allowed to dispose of it as household waste. We
recommend to have it hauled away by a licensed company.
When the CR Plate is disposed of through incineration, the nature of the
combustion products is dependent on the physical characteristics of the
burning process and on the degree of combustion, whereby different gases
can be generated, such as e.g. water vapor, carbon dioxide, carbon monoxide
and small concentrations of organic and inorganic degradation products.
Disposal
Waste codes applicable for European Union:
Plates containing storage phosphor
Product 09 01 99 Waste not otherwise specified
Packaging 15 01 06 Mixed packaging
Information applicable for USA:
Plates containing barium
Product These plates, when discarded, are a hazardous waste
(EPA waste code D005) under the Resource Conserva-
tion and Recovery Act (RCRA) due to the leachability of
barium. Hazardous waste must be managed and trans-
ported in accordance with federal, state, and local regu-
lations. Please contact your local authorities for more
information.
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CR Cassette
The cassette shall not be treated as household waste.
For more detailed information about take-back and proper recycling of this
product, please contact your local sales representative.
This information applies to the cassette only, excluding the plate or screen.
Topics:
•Labeling
•Disposal
Labeling
This label on the cassette indicates that the cassette contains
lead.
Disposal
Waste codes applicable for European Union:
Cassettes containing lead Cassettes not containing
lead
Product 16 02 13* Discarded equip-
ment containing hazardous
components other than those
mentioned in 16 02 09 to 16
02 12
16 02 14 Discarded equipment
other than those mentioned in
16 02 09 to 16 02 13
Packaging 15 01 06 Mixed packaging 15 01 06 Mixed packaging
Information applicable for USA:
Cassettes containing lead
Product These cassettes, when discarded, are a hazardous waste (EPA
waste code D008) under the Resource Conservation and Re-
covery Act (RCRA) due to the leachability of lead. Hazardous
waste must be managed and transported in accordance with
federal, state, and local regulations. Please contact your local
authorities for more information.
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Installation
The tray and image plate have been factory predefined. No further action is
required from customer side to use them with the CR 30-X/CR 30-Xm.
CR 30-X/CR 30-Xm Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 17
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Safety Directions
Topics:
•General Safety Instructions
•Fire Hazard and Extinguishing Media
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General Safety Instructions
CR plates and cassettes will not cause any special health or safety hazard, if
they are used as intended.
CAUTION:
Image quality may suffer if a cassette and plate is not scanned
soon after exposure. The Agfa phosphor has excellent dark
decay characteristics. Two hours after exposure, approximately
80% of the energy stored upon exposure is still available. The
image retention is better than 50% up to 24 hours after
irradiation. However, in order to preserve image quality, a
cassette and plate should be scanned no later than 2 hours after
exposure.
When working with the automatic exposure control device, take into account
the following two safety notices:
• Overexposure (for the MD 4.xT General/FLFS and CR MM 3.xT
Extremities cassettes)
CAUTION:
Automatic Exposure Control device may cause overexposure
if they are positioned underneath the cassette. Make sure
that the automatic exposure control device is placed above
the cassette.
The backscatter protection (lead) contained in the grey side of the
cassette, retains a certain amount of X-rays. The dose measured by the cell
will then be much lower than the dose actually given to the patient.
• Wrong response
CAUTION:
The image plate causes a specific X-ray scattering. This
influences the response of the exposure control device.
Automatic Exposure Control device may give wrong
response. Recalibrate the X-ray device for use with MD 4.xT
and MM3.xT cassettes to compensate for this effect
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Fire Hazard and Extinguishing Media
The screen base is made of polyethylene terephthalate and meets the "Safety
Film" specifications as described in ISO 18906-2000. Safety film passes the
ignition time test when the ignition time is longer than or equals 10 minutes.
It passes the burning time test when the burning time is longer than 45
seconds for a film thickness larger than or equal to 0.08 mm or when the
burning time is longer than 30 seconds for a film thickness smaller than
0.08 mm. The nature of the combustion products depends on the physical
characteristics of the burning process and on the degree of combustion,
whereby different gases can be generated, such as e.g. water vapor, carbon
dioxide, carbon monoxide and small concentrations of organic and inorganic
degradation products.
Fire extinguishing media:
• water spray,
• carbon dioxide,
• extinguishing powder,
• foam.
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