AGFA WS-Motorized-T-001 User manual

WS-Motorized-T-001
5522/600
User Manual
3255F EN 20210312 1125

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 .......................................................... 10
Applied Parts ........................................................... 10
Radiographic wall stand ...............................10
Operation Controls .................................................. 10
Radiographic wall stand ...............................11
Emergency stop button ................................ 12
Installation .............................................................. 14
HF-emission and immunity .......................... 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
Additional Labeling of the Radiographic Wall
Stand ...........................................................23
Cleaning and Disinfecting ........................................24
Cleaning ...................................................... 25
Disinfecting ................................................. 26
Disinfecting safety directions ....................... 27
Approved disinfectants ................................ 28
Maintenance ............................................................29
Maintenance of the radiographic table,
radiographic wall stand and X-Ray Tube Head Unit
..........................................................................29
Safety Directions ..................................................................31
General Safety Directions .........................................31
Radiographic Wall Stand ..................................................... 33
Positioning the Radiographic Wall Stand ................. 35
Tracking the radiographic wall stand ....................... 37
Radiographic Wall Stand Accessories .......................39
Patient hand grips ........................................40
Mounting the lateral arm rest .......................41
Spacer ......................................................... 42
Wall stand fixation kit ..................................43
Product Information ............................................................ 44
Compatibility ...........................................................45
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Compliance ............................................................. 45
General ........................................................46
Safety .......................................................... 46
Electromagnetic Compatibility .....................46
X-Ray Safety .................................................47
X-Ray Accuracy ............................................ 47
Environmental Compliance ..........................47
Biocompatibility ...........................................47
Usability ...................................................... 47
Equipment Classification ......................................... 48
Product Complaints ................................................. 49
Environmental protection ........................................ 50
Training ...................................................................51
Technical Data .........................................................52
Wall Stand Technical Data ........................... 52
Remarks for HF-emission and immunity ..................54
Immunity to RF wireless communication
equipment ................................................... 59
Precautions on EMC .....................................60
Cables, transducers and accessories ............. 61
Maintenance on EMC relevant parts .............65
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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. All 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 2021 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:
•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 600 System, an integrated
X-Ray imaging system. It explains how the different components of the DR
600 System work together.
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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 on order
of a physician for prescription use only.
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Introduction
Topics:
•Intended Use
•Intended User
•Applied Parts
•Operation Controls
•Installation
•Radiation Protection
•Labels
•Cleaning and Disinfecting
•Maintenance
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Intended Use
The wall stand is a component of a general radiography X-ray imaging system
used in hospitals, clinics and medical practices by physicists, radiographers
and radiologists to support examinations with patient standing upright or
sitting.
The device is not intended for mammography applications.
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.
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)
Operation Controls
Topics:
•Radiographic wall stand
•Emergency stop button
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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 33
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Emergency stop button
If a system malfunction causes an emergency situation involving the patient,
operating personnel or any system component, activate the emergency stop
button.
• On the front side of the radiographic table (right)
• On the rear side of the radiographic table (left)
• On the top side of the X-ray tube cover
• Close to the radiographic wall stand
• In the operator room
Figure 2: Multiple emergency stop buttons are available on the system
All motor driven movements will be stopped. Motor driven movements:
• Radiographic table
• Radiographic wall stand
• Ceiling suspension
To allow motorized movements again, turn the cap of the emergency switch in
clockwise direction (default position) and restart the system using the X-ray
generator mini console.
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CAUTION:
The emergency stop button does not switch off the voltage in
the X-ray system.
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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.
On a configuration with multiple DR detectors of the same type, it is required
to apply labeling to the DR detector containing a unique nickname for each
DR detector. The nicknames must be configured on the MUSICA Acquisition
Workstation. The DR Detector Switch shows which DR detector is active and
shows its status, by means of the nickname of the DR detector.
An identical label is attached to the bucky of the X-ray system to identify the
dedicated workspace of each DR detector.
HF-emission and immunity
The HF-emission and immunity can be influenced by connected data cables
depending on length and the manner of installation.
A specific installation environment may require special measures to put the
system into operation according to the remarks for HF-emission and
immunity.
Related Links
Cables, transducers and accessories on page 61
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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 and the
material of the object. 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, 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
2
5
4
3
r = 140 cm
(55,1")
1
1. X-ray generator
2. X-ray room
3. Patient environment
4. Workstation
5. Operator room: protected area
Figure 3: Protected area and significant zones of occupancy
CAUTION:
The radiation protection has to be applied to the patient.
The position of the patient environment depends on the position of the X-ray
tube.
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.
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CAUTION:
The radiation protection has to be applied to the patient and to
the operator.
Related Links
Radiation Protection on page 15
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 4: Significant zones of occupancy at the radiographic wall stand
CAUTION:
The radiation protection has to be applied for the patient and for
the operator.
Related Links
Radiation Protection on page 15
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Labels
Mark Meaning
This mark shows compliance of the equipment with Regulation
2017/745 (for European Union).
This mark indicates that this is a Type B Equipment
Date of manufacture
Manufacturer
Medical device
Serial number
Unique device identifier, in text format and in machine readable
format
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
Label Meaning
Dangerous voltage
Ionizing radiation
Pinch Points.
Risk of stumbling.
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