AGFA CR MD1.0 GENERAL SET User manual

AGFA CR Plates and Cassettes
CR MD1.0 GENERAL SET
CR HD5.0S General
CR MD1.0F General
CR DD1.0 Vet
User Manual
2492F EN 20180417 1049

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
System Documentation ............................................12
Product Complaints ................................................. 13
Compliance ..............................................................14
Design ......................................................... 15
Labeling .......................................................15
Environmental Protection ........................................ 16
CR Plate ....................................................... 17
CR Cassette ..................................................18
Safety Directions ......................................................19
General Safety Instructions .......................... 19
Using the Agfa CR Plates and Cassettes ................................ 20
CR MD1.0 Cassettes ................................................. 21
Large format CR General cassette ................22
Small format CR General cassette ................ 24
Image Plate ..................................................26
CR HD5.0S General Detector ................................... 27
Orientation of large format CR General cassette .......29
Orientation of small format CR General cassette ...... 30
CR Full Leg Full Spine (FLFS) cassette ......................31
CR MD1.0F General Image Plate and Cassette ..........32
Exposure outside the cassette .......................33
Performing an examination ......................... 34
Compatibility ...............................................35
Cleaning the image plate adapter .................36
CR DD1.0 Vet Image Plate and Cassette ....................37
Exposure outside the cassette .......................39
Performing an examination ......................... 40
Black border and cropping on NX .................42
Cleaning the image plate adapter .................43
Precautionary Measures .......................................... 44
First Use and Normal Operation ...................45
Transport .....................................................45
Storage ........................................................ 45
Maximum Cassette Load .............................. 45
Handling the Image Plate .............................46
Cleaning ...................................................... 46
Quality Control ............................................52
ii | AGFA CR Plates and Cassettes | Contents
2492F EN 20180417 1049

Specifications .......................................................... 53
AGFA CR Plates and Cassettes | Contents | iii
2492F EN 20180417 1049

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 MD1.0 General, CR MD1.0F, CR DD1.0 Vet, CR HD5.0S and
NX 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 Plates and Cassettes | Legal Notice
2492F EN 20180417 1049

Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
AGFA CR Plates and Cassettes | Introduction to this Manual | 5
2492F EN 20180417 1049

Scope
This manual contains information for safe and effective operation of the CR
MD1.0 General, CR HD5.0S General, CR MD1.0F General and CR DD1.0 Vet
Plates and Cassettes.
6 | AGFA CR Plates and Cassettes | Introduction to this Manual
2492F EN 20180417 1049

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.
AGFA CR Plates and Cassettes | Introduction to this Manual | 7
2492F EN 20180417 1049

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 Plates and Cassettes | Introduction to this Manual
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Introduction to Agfa CR Plates and
Cassettes
Topics:
•Intended Use
•Intended User
•System Documentation
•Product Complaints
•Compliance
•Environmental Protection
•Safety Directions
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 9
2492F EN 20180417 1049

Intended Use
The CR MD1.0 General and CR HD5.0S General image plates and cassettes are
part of a CR system, further containing a digitizer 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.
The CR DD1.0 Vet image plate and cassette is used for intra oral dental
radiography. The CR DD1.0 Vet image plate and cassette must be used for
veterinary applications only.
The flexible CR MD1.0F General image plate and and the CR DD1.0 Vet image
plates are exposed outside of the cassette.
10 | AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes
2492F EN 20180417 1049

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.
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 11
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System Documentation
The documentation shall be kept with the system for easy reference.
For information and safety notes on the digitizer systems, refer to the user
manual of the digitizer.
12 | AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes
2492F EN 20180417 1049

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]
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 13
2492F EN 20180417 1049

Compliance
The CR MD1.0, CR HD5.0S and CR MD 1.0F plate and cassette complies with
the following safety requirements.
The CR DD1.0 Vet image plate and cassette must be used for veterinary
applications only. The cassette does not carry the CE mark and is not
compliant with Directive 93/42/EEC. (For European Union)
Topics:
•Design
•Labeling
14 | AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes
2492F EN 20180417 1049

Design
• ISO4090:2001 Photography - Medical radiographic cassettes/screens/
films and hard-copy imaging films - Dimensions and specifications
• IEC 62366:2007 Medical devices - Application of usability engineering to
medical devices
• RoHS Directive 2002/95/EC
Labeling
• ISO 15223:2000 incl. amdt 1:2002 Medical devices - Symbols to be used
with medical device labels, labelling and information to be supplied
• EN 1041:2008, Information supplied by the manufacturer with medical
devices
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 15
2492F EN 20180417 1049

Environmental Protection
Topics:
•CR Plate
•CR Cassette
16 | AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes
2492F EN 20180417 1049

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 Conservation
and Recovery Act (RCRA) due to the leachability of bari-
um. Hazardous waste must be managed and transported
in accordance with federal, state, and local regulations.
Please contact your local authorities for more informa-
tion.
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 17
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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.
Disposal
Waste codes applicable for European Union:
Cassettes
Product 16 02 14 Discarded equipment other than those men-
tioned in 16 02 09 to 16 02 13
Packaging 15 01 06 Mixed packaging
Information applicable for USA:
Cassettes
Product
Hazardous waste must be managed and transported in
accordance with federal, state, and local regulations.
Please contact your local authorities for more informa-
tion.
18 | AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes
2492F EN 20180417 1049

Safety Directions
General Safety Instructions
CR plates and cassettes will not cause any special health or safety hazard, if
they are used as intended.
When working with the automatic exposure control device, take into account
the following two warnings and read the instruction:
• Overexposure (for the MD1.0 General)
CAUTION:
Automatic Exposure Control devices may cause
overexposure if they are positioned underneath the
cassette.
The image plate retains a certain amount of X-rays. The dose
measured by the cell will then be lower than the dose
actually given to the patient.
Make sure that the automatic exposure control device is
placed above the cassette.
• Wrong response
CAUTION:
Automatic Exposure Control device may give a wrong
response.
The image plate causes a specific X-ray scattering. This
influences the response of the exposure control device.
Recalibrate the X-Ray device for use with MD1.0 cassettes to
compensate for this effect.
AGFA CR Plates and Cassettes | Introduction to Agfa CR Plates and Cassettes | 19
2492F EN 20180417 1049

Using the Agfa CR Plates and Cassettes
Topics:
•CR MD1.0 Cassettes
•CR HD5.0S General Detector
•Orientation of large format CR General cassette
•Orientation of small format CR General cassette
•CR Full Leg Full Spine (FLFS) cassette
•CR MD1.0F General Image Plate and Cassette
•CR DD1.0 Vet Image Plate and Cassette
•Precautionary Measures
•Specifications
20 | AGFA CR Plates and Cassettes | Using the Agfa CR Plates and Cassettes
2492F EN 20180417 1049