AGFA 5522/100 User manual

WS-Manual-001, WS-Manual-
T-001, WS-Manual-002, WS-
Manual-T-002
5522/100
5522/200
5522/300
5522/400
User Manual
3252C EN 20191206 1610

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 DR 400 ..........................................................9
Intended Use ............................................................10
Intended User .......................................................... 10
Applied Parts ........................................................... 10
Radiographic wall stand ...............................10
Equipment Classification ..........................................11
Operation Controls .................................................. 12
Radiographic wall stand .............................. 13
Emergency stop button .................................14
Training ...................................................................15
Product Complaints ................................................. 16
Compatibility ........................................................... 17
Compliance ..............................................................18
General ........................................................19
Safety .......................................................... 19
Electromagnetic Compatibility ..................... 19
X-Ray Safety .................................................19
X-Ray Accuracy ............................................ 20
Environmental Compliance ..........................20
Biocompatibility .......................................... 20
Connectivity ............................................................ 21
Installation .............................................................. 22
HF-emission and immunity .......................... 22
Radiation Protection ................................................23
Monitoring of Personnel .............................. 24
Protected area and significant zones of occupancy
..........................................................................25
Labels ...................................................................... 28
Warning labels on the radiographic wall stand .
30
Additional Labeling of the radiographic wall stand
..........................................................................31
Cleaning and Disinfecting ........................................ 32
Cleaning ...................................................... 33
Disinfecting ................................................. 34
Disinfecting safety directions ....................... 35
Approved disinfectants ................................ 36
Maintenance ............................................................37
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Maintenance of the radiographic table,
radiographic wall stand and X-Ray Tube Stand .
37
Environmental protection ........................................ 39
Safety Directions ......................................................40
General Safety Directions .............................41
Safety directions for the radiographic wall stand
..........................................................................43
Operation ............................................................................44
Radiographic wall stand .......................................... 44
Positioning the Radiographic Wall Stand ..... 46
Radiographic Wall Stand Accessories ........... 49
Technical Data ..................................................................... 51
Radiographic Wall Stand Technical Data ..................51
Environmental conditions ............................52
Remarks for HF-emission and immunity ..............................54
Immunity to RF wireless communication equipment ....
59
Precautions on EMC .................................................60
Cables, transducers and accessories ......................... 61
For type 5520/200 only ............................... 63
Maintenance on EMC relevant parts ........................ 64
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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 2019 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 WS-Manual-L-001, WS-
Manual-R-001, WS-Manual-T-L-001 and WS-Manual-T-R-001, further referred
to as the radiographic wall stand, that is part of the DR 400 system.
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Manual
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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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Manual
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Introduction to DR 400
Topics:
•Intended Use
•Intended User
•Applied Parts
•Equipment Classification
•Operation Controls
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Radiation Protection
•Labels
•Cleaning and Disinfecting
•Maintenance
•Environmental protection
•Safety Directions
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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
• Overhead arm support (optional)
• Patient hand grips (optional)
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Equipment Classification
Per EN/IEC 60601-1, EN/IEC 60601-2-54, this device is classified as
following:
Table 1: Equipment classification
Class I equipment Equipment in which protection against electric
shock does not rely on basic insulation only, but in-
cludes a fixed connection to mains power with pro-
tective earth conductor.
Type B equipment A Type B piece of equipment is one that provides a
particular degree of protection against electric
shock particularly regarding allowable leakage cur-
rent and reliability of the protective earth protec-
tion.
Water ingress IP10
This device does not have protection against in-
gress of water.
Cleaning See section on cleaning and disinfecting.
Disinfection See section on cleaning and disinfecting.
Flammable anesthetics This device is not suitable for use in the presence of
a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
Operation Continuous operation.
Related Links
Cleaning and Disinfecting on page 32
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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 44
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Emergency stop button
Figure 2: Emergency stop button
If a system malfunction causes an emergency situation involving the patient,
operating personnel or any system component, activate the emergency stop on
the radiographic table. All motor driven movements will be stopped.
Motor driven movements:
• Radiographic table
• Radiographic wall stand
• X-ray tube stand
To allow motorized movements again, turn the cap of the emergency switch in
clockwise direction (default position).
WARNING:
The emergency stop button does not switch off the voltage in
the X-ray system.
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Training
The user must have received adequate training on the safe and effective use of
the system before attempting to work with it. Training requirements may vary
from country to country. The user must make sure that training is received in
accordance with local laws or regulations that have the force of law. Your local
Agfa or dealer representative can provide further information on training.
The user must note the following information in the system documentation:
• Intended Use.
• Intended User.
• Safety Directions.
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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.
For a patient/user/third party in the European Union and in countries with
identical regulatory regimes (Regulation 2017/745/EU on Medical Devices);
if, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorised
representative and to your national authority.
Manufacturer 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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Compatibility
The system must only be used in combination with other equipment or
components if these are expressly recognized by Agfa as compatible. A list of
such equipment and components is available from Agfa service on request.
Changes or additions to the equipment must only be carried out by persons
authorized to do so by Agfa. Such changes must comply with best engineering
practice and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
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Compliance
The system is compliant with specific directives and standards.
Topics:
•General
•Safety
•Electromagnetic Compatibility
•X-Ray Safety
•X-Ray Accuracy
•Environmental Compliance
•Biocompatibility
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General
• The product has been designed in accordance with Regulation (EU)
2017/745 on medical devices (MDR)
• ISO 13485
• ISO 14971
Safety
• IEC 60601-1
• IEC 60601-1-6, EN 60601-1-6
• CSA C22.2 60601-1
• AAMI ES 60601-1
Electromagnetic Compatibility
• IEC 60601-1-2, EN 60601-1-2
Topics:
•For USA
•For Canada
For USA
This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the installation manual, may cause harmful
interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user
will be required to correct the interference at his own expense. If required,
contact your local service organization.
For Canada
This class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.
X-Ray Safety
• IEC 60601-1-3
• IEC 60601-2-54
• IEC 60601-2-28
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For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
X-Ray Accuracy
The system fulfills the X-ray radiation accuracy according EN IEC 60601-2-54
with a variation of max. 0.05 (5%).
Environmental Compliance
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)
Biocompatibility
• EN ISO 10993-1
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