AGFA 6005/100 6005/200 User manual
Full Leg Full Spine DR Retrofit
System
6005/100
6005/200
User Manual
0326A EN 20211014 1141
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 the Full Leg Full Spine application ................. 9
Intended Use ............................................................10
Intended User .......................................................... 10
Connectivity ............................................................ 11
Configuration .......................................................... 12
Full Leg Full Spine wall stand .......................13
External collimator ...................................... 17
Compliance ..............................................................18
General ........................................................19
Safety .......................................................... 19
Electromagnetic Compatibility ..................... 19
Environmental Compliance ..........................19
Equipment Classification ......................................... 20
System Documentation ............................................ 21
Product Complaints ................................................. 22
Installation .............................................................. 23
Accuracy of Measurements ...................................... 24
Labels ...................................................................... 25
Additional labeling for the wall stand ...........27
Additional labeling for the external collimator .
27
Cleaning and Disinfecting ........................................ 28
Cleaning ...................................................... 29
Disinfecting ................................................. 30
Approved disinfectants .................................31
Maintenance ............................................................32
Recurrent safety tests ...................................32
Environmental protection ........................................ 33
Safety Directions ......................................................35
Basic Workflow ....................................................................37
Starting the DR Full Leg Full Spine application ........ 38
Retrieve the patient info .......................................... 39
Select the exposure ..................................................40
Prepare the Full Leg Full Spine configuration ........... 41
Prepare the Full Leg Full Spine configuration with
external collimator .................................................. 42
Prepare the examination ..........................................44
Execute the exposures ..............................................45
Execute the exposures with external collimator ....... 46
Perform a quality control ......................................... 47
ii | Full Leg Full Spine DR Retrofit System | Contents
0326A EN 20211014 1141
Finalize the examination ..........................................50
Stopping the DR Full Leg Full Spine application ....... 51
Advanced Operation ............................................................ 52
Manually adjusting a DR Full Leg Full Spine image ....
53
To rotate all partial images ...........................54
To stitch a set of partial images .................... 55
To align the partial images based on their
projection on the stitching grid .................... 56
To align the partial images based on the analysis
of the anatomical information in the image ....
57
To manually align two partial images ...........58
To turn the black borders or cropping on or off
60
To save the stitched image ............................61
Rejecting a DR Full Leg Full Spine image ..................61
Making measurements .............................................62
DAP reading when using the external collimator ......64
Problem solving ...................................................................65
Anatomical stitching is not optimal .......................... 66
Stitching fails ...........................................................67
Not all three DR detector positions are available ...... 68
Technical Data .....................................................................69
Full Leg Full Spine wall stand technical data ............ 70
External collimator technical data ............................72
Remarks for HF-emission and immunity ..................73
Precautions on EMC .....................................79
Immunity to RF wireless communication
equipment ................................................... 80
Cables, transducers and accessories ............. 81
For USA ....................................................... 82
For Canada .................................................. 83
Full Leg Full Spine DR Retrofit System | Contents | iii
0326A EN 20211014 1141
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. DX-D 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 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
4 | Full Leg Full Spine DR Retrofit System | Legal Notice
0326A EN 20211014 1141
Scope of this Manual
This manual contains information for the safe and effective operation of the
Full Leg Full Spine DR Retrofit System and the following accessories:
• Full Leg Full Spine wall stand
• Full Leg Full Spine control unit
• External collimator (optional)
6 | Full Leg Full Spine DR Retrofit System | Introduction to this Manual
0326A EN 20211014 1141
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.
Full Leg Full Spine DR Retrofit System | Introduction to this Manual | 7
0326A EN 20211014 1141
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.
8 | Full Leg Full Spine DR Retrofit System | Introduction to this Manual
0326A EN 20211014 1141
Introduction to the Full Leg Full Spine
application
Topics:
•Intended Use
•Intended User
•Connectivity
•Configuration
•Compliance
•Equipment Classification
•System Documentation
•Product Complaints
•Installation
•Accuracy of Measurements
•Labels
•Cleaning and Disinfecting
•Maintenance
•Environmental protection
•Safety Directions
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 9
0326A EN 20211014 1141
Intended Use
The FLFS DR Retrofit System will be used in a radiological environment by
qualified staff to read-out, process and route static X-ray radiographic images.
The system is intended to support acquisition of FLFS images in an X-ray
system.
Intended User
This manual is written for trained users of Agfa products and trained clinical
personnel. Users are considered as the persons who actually handle the
equipment as well as the persons having 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.
10 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application
0326A EN 20211014 1141
Connectivity
The NX workstation is connected to the X-ray system to exchange X-ray
exposure parameters.
The NX workstation requires a 100 Mbit ethernet network to exchange
information with a number of other devices.
The NX workstation communicates with other devices in the hospital network
using one of the following protocols:
• DICOM
• IHE
The NX workstation can be connected to a RIS system (input scheduling), a
PACS system (output image/data management) and to a hardcopy device
(output image).
Note: The connections between the components of the system are
separate from the hospital network and should not be disconnected
or modified.
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 11
0326A EN 20211014 1141
Full Leg Full Spine wall stand
The DR Full Leg Full Spine detector positioner (type 6005/100) contains a
wall stand and a control unit.
1
2
3
1. Wall-mounted base with height adjustment mechanism (optional) or fixed
height wall-mounted base
2. DR detector holder
3. Front panel
Figure 1: Full Leg Full Spine wall stand
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 13
0326A EN 20211014 1141
1
2
3
4
1. Front panel containing the Full Leg Full Spine stitching grid
2. Anti-scatter grid (optional)
3. DR detector
4. Internal mechanism to automatically position the detector and anti-scatter
grid for making Full Leg Full Spine partial images
Figure 2: DR detector holder
Topics:
•Front panel of the DR detector holder
•Control unit
•Anti-scatter grids
14 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application
0326A EN 20211014 1141
Front panel of the DR detector holder
1159
367
367
425 x 425 mm =
e?ective area
17 x 17 inch
detector
(DR 17e)
1
3
4
3
3
2
1. Region of interest when using a 17x17 inch DR detector
2. Width of the region of interest when using a 14x17 inch DR detector
3. Center line for each position of the DR detector
4. Overlap zone
Figure 3: Front panel of the DR detector holder
Control unit
1
2
1. Button to move the DR detector to the next position.
2. Indicator for the current position of the DR detector.
Figure 4: Control unit
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 15
0326A EN 20211014 1141
Table 1: Indication of current position
Three leds Top most position
Two leds Middle position
One led Bottom most position
When the DR detector is moving, the led of the target position is blinking.
When all leds are blinking, an error has occurred. Unplug the system to reset
it.
Related Links
Not all three DR detector positions are available on page 68
Anti-scatter grids
Anti-scatter grids are used to reduce scattered radiation and improve image
quality. Grids are available as an option.
Refer to the Agfa website for specifications on the anti-scatter grids that have
been found compatible with the system and the DR Detectors.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=54332498
16 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application
0326A EN 20211014 1141
External collimator
External collimator (type 6005/200, optional).
1
2
5
3
4
1. Vertical column with internal mechanism to automatically position the
collimator for making Full Leg Full Spine partial images
2. X-ray collimator
3. Initialization button
4. Height adjustment button
5. Floor mount lock
Figure 5: External collimator (optional)
The movement of the collimator is synchronized with the movement of the DR
detector and anti-scatter grid.
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 17
0326A EN 20211014 1141
General
• The DR Full Leg Full Spine detector positioner has been designed in
accordance with Regulation (EU) 2017/745 on medical devices (MDR).
• The external collimator has been designed in accordance with the
MEDDEV Guidelines relating to the application of Medical Devices and
have been tested as part of the conformity assessment procedures required
by 93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices) amended by European Directive
2007/47/CE.
Safety
• IEC 60601-1
• IEC 60601-1-3
• IEC 60601-1-6
• IEC 60601-2-54
• ANSI/AAMI ES60601-1
• CAN/CSA-C22.2 No. 60601-1:14
Electromagnetic Compatibility
• IEC 60601-1-2
Environmental Compliance
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 19
0326A EN 20211014 1141
Equipment Classification
Per EN/IEC60601-1, this device is classified as following:
Table 2: Equipment classification
Class I Equip-
ment
Equipment in which protection against electric shock does
not rely on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth relia-
bility always plug the main power cord into an earthed
mains power outlet.
Type B Equip-
ment
A Type B applied part is one that provides a particular de-
gree of protection against electric shock particularly re-
garding allowable leakage current and reliability of the
protective earth protection.
Water Ingress This device does not have protection against ingress of wa-
ter.
Cleaning See section on maintenance and cleaning.
Disinfection See section on maintenance and cleaning.
Flammable An-
esthetics
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 ox-
ide.
Continuous Op-
eration
The unit is suitable to run continuously.
Expected serv-
ice life
Minimum 7 years.
20 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application
0326A EN 20211014 1141
Table of contents
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