AGFA DR 400 User manual

DR 400 (Radiographic wall stand)
5520/150
User Manual
3256C EN 20221124 1627

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 .......................................................................... 9
Intended Use ............................................................10
Intended User .......................................................... 11
Radiographic wall stand .......................................... 12
Applied Parts ........................................................... 13
Radiographic wall stand .............................. 13
Installation .............................................................. 14
Radiation Protection ................................................15
Monitoring of Personnel ...............................16
Protected area and significant zones of occupancy
..........................................................................17
Labels ...................................................................... 20
Warning labels on the radiographic wall stand .
22
Type label .................................................... 23
Additional Labeling of the radiographic wall stand
..........................................................................24
Labeling of the bucky ...................................25
Cleaning and Disinfecting ........................................26
Cleaning ...................................................... 27
Disinfecting ................................................. 28
Disinfecting safety directions ....................... 29
Approved disinfectants ................................ 30
Maintenance ............................................................31
Maintenance of the radiographic wall stand ....
31
Environmental protection ........................................ 33
Safety Directions ..................................................................34
General Safety Directions .........................................35
Safety directions for the radiographic wall stand ......37
Radiographic wall stand ...................................................... 38
Positioning the Radiographic Wall Stand ................. 40
Radiographic Wall Stand Accessories .......................42
Patient hand grips ........................................43
Mounting the lateral arm rest ...................... 44
Spacer ......................................................... 45
Wall stand fixation kit ..................................46
Bucky .................................................................................. 47
Bucky configuration ................................................ 49
Rotating the bucky ...................................................50
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Loading of the bucky in the Radiographic Wall Stand ...
51
Unloading of the bucky in the Radiographic Wall Stand
......................................................................................52
Cassette and detector formats .................................. 53
Standard cassette formats ........................................54
DR Detector formats and orientation ....................... 55
Anti-scatter grids ..................................................... 56
Anti-scatter grids ......................................... 57
Anti-scatter grid focal distance color indication
58
Product Information ............................................................ 59
Compatibility ...........................................................60
Compliance ............................................................. 60
General ........................................................61
Safety ...........................................................61
Electromagnetic Compatibility ..................... 61
Environmental Compliance ..........................61
Biocompatibility .......................................... 62
Equipment Classification ......................................... 63
Product Complaints ................................................. 64
Training ...................................................................65
Technical Data .........................................................66
DR 400 Technical Data .................................67
Radiographic Wall Stand Technical Data ......68
Bucky Unit Technical Data ........................... 70
Fixed mounted DR detector technical data ... 72
Remarks for HF-emission and immunity ..................74
Immunity to RF wireless communication
equipment ................................................... 79
Precautions on EMC .....................................80
Cables, transducers and accessories ............. 81
Maintenance on EMC relevant parts .............82
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Legal Notice
2862
Agfa NV, Septestraat 27, 2640 Mortsel - Belgium
For more information on Agfa products, please visit medimg.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or
its affiliates. DR 400 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 2022 Agfa NV
All rights reserved.
Published by Agfa NV
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:
•Scope of this Manual
•About the safety notices in this document
•Disclaimer
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Scope of this Manual
This User Manual describes the features of the DR 400 wall stand, further
referred to as the radiographic wall stand, that is a variant of the DR 800
system.
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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, service
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, service 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, service 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 on order
of a physician for prescription use only.
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Introduction
Topics:
•Intended Use
•Intended User
•Radiographic wall stand
•Applied Parts
•Installation
•Radiation Protection
•Labels
•Cleaning and Disinfecting
•Maintenance
•Environmental protection
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Intended Use
• The DR 400 system is a General Radiography X-ray imaging system used in
hospitals, clinics and medical practices by physicists, radiographers and
radiologists to make, process and view static X-ray radiographic images of
the skeleton (including skull, spinal column and extremities), chest,
abdomen and other body parts on adult or pediatric patients.
• Applications can be performed with the patient in the sitting or standing
position.
• This device is not intended for mammography applications.
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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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Radiographic wall stand
The radiographic wall stand is used for positioning of patients standing
upright or sitting towards the bucky for exposure.
Figure 1: Radiographic wall stand with vertical bucky
Related Links
Radiographic wall stand on page 38
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Applied Parts
Applied Parts refer to parts of the medical electrical equipment that in normal
use necessarily comes into physical contact with the patient for the equipment
to perform its function. This system includes the following Applied Parts:
Radiographic wall stand
• Front panel of the radiographic wall stand
• Lateral arm rest (optional)
• Patient hand grips (optional)
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Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
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Radiation Protection
X-ray radiation can cause serious damage to the health, therefore observe
great care and ensure that protection against X-ray exposure is always applied.
Some of the effects of X-ray radiation are cumulative and may extend over a
period of time. Therefore the X-ray operator should avoid exposure by X-ray
radiation at all times.
Objects in the path of the X-ray beam may produce scattered radiation. The
intensity depends on the energy and intensity of the X-ray exposure, the
material of the object and the distance to the object producing scattered
radiation. Protective measures have to be taken to prevent exposure through
scattered radiation.
Protective measures include:
• structural configuration of the X-ray room (e.g. lead shielded rooms)
• radiation protection for the operators (e.g. personal radiation dosimeters,
lead aprons, radiation protection glasses, mobile lead screens, keep
maximum distance from X-ray source and from the object producing
scattered radiation, regular training, etc.)
• protection of patients against unnecessary radiation (e.g. limitation of X-
ray field by collimation, lead shielding, lead aprons, etc.)
Topics:
•Monitoring of Personnel
•Protected area and significant zones of occupancy
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Monitoring of Personnel
The monitoring checks the amount of X-ray radiation the personnel has been
exposed to. It determines safety of the operators and it helps checking if safety
measures of the X-ray environment are adequate. Inadequate or improper
protection can lead to serious damage to the health.
To measure radiation, personal radiation dosimeters are typically used. They
are worn on the body at all times during working in an environment where X-
ray radiation is applied. They provide an indication for the amount of
radiation the operator was exposed to.
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Protected area and significant zones of occupancy
If the operator or staff does not need to be close to the patient during the
exposure, the operator and staff use the protected area to control the
following functions:
• selection of mode of operation
• selection of exposure settings (X-ray loading factors)
• actuation of the exposure button
• other necessary controls for the operator during exposure
6
1
2
3
4
1. X-ray room
2. Patient environment
3. Workstation
4. Operator room: protected area
Figure 2: Protected area and significant zones of occupancy
WARNING:
The patient must wear appropriate radiation protection
garments.
If operator or staff needs to be close to the patient during normal use (e.g.
some pediatric examinations or types of examinations for which the patient
requires assistance), the significant zone of occupancy applies for operator
and staff.
Keep maximum distance from the X-ray source and from the object producing
scattered radiation. The intensity of scattered radiation depends on the energy
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and intensity of the X-ray exposure, the material of the object and the distance
to the object.
WARNING:
The patient and the operator must wear appropriate radiation
protection garments.
Significant zones of occupancy at the radiographic wall stand
140 cm
SID115 cm
Phantom
S1 S2
S
S
50 cm
1
2
3
42
5
6
7
2
1
8
9
1. X-ray tube
2. Focal spot label [—]
3. Significant zone of occupancy.
Minimum area 60x60 cm.
Minimum height above the floor 200 cm.
4. Dose meter
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5. Protective device
6. Wall
7. DR Detector or cassette
8. Significant zone of occupancy at the right side of the radiographic wall
stand
9. Significant zone of occupancy at the left side of the radiographic wall
stand
Figure 3: Significant zones of occupancy at the radiographic wall stand
CAUTION:
The radiation protection has to be applied for the patient and for
the operator.
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Labels
Mark Meaning
This mark shows compliance of the equipment with Regulation
2017/745 (for European Union).
Type B applied part
Date of manufacture
CC
Country of origin. The two character code on the actual label
contains the country code defined in ISO 3166-1.
Manufacturer
Medical device
Serial number
Unique device identifier, in text format and in machine readable
format
#
Type and subtype number
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
Read the instructions in the user manual.
Label Meaning
Dangerous voltage
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