DX-G DX-M: User Manual
DX-G DX-M: User Manual
DX-G DX-M: User Manual
(type 5170/100)
DX-M
(type 5170/200)
User manual
M
2321 B EN 20100212
DX-G/DX-M
0413
For more information on Agfa products and Agfa HealthCare products, please visit www.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DX-G, DX-M and IMPAX
are trademarks of Agfa HealthCare N.V., 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 HealthCare N.V. 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 con-
tact your local sales representative for availability information. Agfa HealthCare N.V. diligently strives to provide
as accurate information as possible, but shall not be responsible for any typographical error. Agfa HealthCare N.V.
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 HealthCare N.V. reserves the right to make
changes to this document without prior notice.
Copyright 2010 Agfa HealthCare N.V.
All rights reserved.
Published by Agfa HealthCare N.V.
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 HealthCare N.V.
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1 Introduction .......................................................................................7
Basic Features................................................................................................... 38
DX-G/DX-M Features.......................................................................................... 38
Operating Modes ............................................................................................... 39
Operator Mode .............................................................................................. 39
Service Mode................................................................................................. 39
The User Interface ............................................................................................ 40
Status Indicator.................................................................................................. 41
Starting the Digitizer ........................................................................................ 42
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Appendix ..................................................................................................65
Specifications ................................................................................................... 68
Pixel Matrix Size ............................................................................................... 71
Compliance....................................................................................................... 74
Certificates ........................................................................................................ 74
Harmonization................................................................................................... 75
Connectivity ..................................................................................................... 76
Environmental Protection ................................................................................ 76
Remarks for HF-emission and immunity .......................................................... 78
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1 Introduction
This chapter covers the following topics:
Scope
Disclaimer
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Scope
This manual contains information for safe and effective operation of the
DX-GTM/DX-MTM digitizers.
Caution: Cautions are directions which, if they are 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 have been made to the content or format.
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 stipulates that medical devices
should only be sold to, distributed and used by or by order of a licensed
physician.
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Introduction to DX-G/DX-M
This section covers the following topics:
Intended Use
Intended User
Configuration
System Documentation
Training
Product Complaints
Compatibility
Compliance
Installation
Labels
Safety Directions
Quality Control
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Intended Use
This device must only be used to scan exposed X-ray cassettes, containing an
erasable image plate (IP). The digitizer is part of a system, consisting of X-ray
cassettes with erasable phosphor image plates and a workstation where the X-
ray cassettes are identified and the resulting digital image information is
further processed and routed. It is intended that this device is only operated
in a radiological environment by qualified staff.
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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Configuration
The digitizer is part of a CR system that has the following configuration:
• The digitizer, a digitizer for scan of image plates retaining latent X-ray
images. The digitizer accepts multiple cassettes at a time, to be scanned
sequentially.
• The NX Workstation, one or more CR workstations with ID Tablet for cassette
identification, image processing and image transmission of digitized images
received from the digitizer.
• Cassette and plate system: AGFA CR HD5.x GenRad detectors, CR HD5.x AEC
detectors and CR MD4.xR GenRad plates and cassettes.
• For DX-M additionally, AGFA CR HM5.x Mammo detectors or CR MM3.xR
Mammo plates and cassettes - mixed use of both types in one digitizer will not
be supported.
System Documentation
The documentation consists of following items:
• DX-G and DX-M User Manual.
• DX-G and DX-M Workflow Sheets.
• AGFA CR Detectors, Plates and Cassettes (CR HD5.x; CR MD4.xR; CR HM5.x;
CR MM3.xR).
• CR Full Leg Full Spine User Manual (4408).
• NX User Manual.
• CR Mammography System User Manual (2344).
The documentation shall be kept with the system for easy reference. Technical
documentation is available in the product service documentation which is
available from your local support organization.
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Training
The user must have received adequate, Agfa certified training on the safe and
effective use of the product before attempting to work with it. Training
requirements may vary from country to country. The user must ensure that
training is received in accordance with local laws or regulations that have the
force of law. Your Agfa certified representative can provide further
information on certified training.
The user must note the following information in the preliminary section of
this manual:
• “Intended Use” on page 12.
• “Intended User” on page 12.
• “Safety Directions” on page 32.
Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction in 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 of a patient, Agfa must be notified immediately by telephone, fax or
written correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers listed on
www.agfa.com
Agfa HealthCare N.V. - Septestraat 27 - 2640 Mortsel, Belgium.
Agfa HealthCare N.V. - Fax +32 3 444 7094.
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Compatibility
The digitizer 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
practices and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 60950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system, and is therefore responsible
that the system complies with the requirements of the valid version of the
system standard IEC 60601-1-1. If in doubt, consult your local service
organization.
Caution: The digitizer must not be connected to any version of the Agfa
ADC QSTM or ADC VIPSTM Software.
Compliance
The digitizer 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 MDD
(European Council Directive 93/42/EEC on Medical Devices).
The digitizer has been designed in accordance with the IEC 60601-1, Ed. 2:
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
Refer to Appendix B for an overview of applied standards.
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Labelling
CE label:93/42 EEC 'Medical Devices' (Europe), EN 60601-1
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Installation
Caution: The digitizer and the cassette storage shall be protected against
direct radiation in such a way, that the annual dose equivalent at the
place of installation will not exceed 1 mSv/a.
Caution: When installing the digitizer, care must be taken to ensure that
there is either a mains plug or an all-cable disconnecting device in the
internal installation fitted near the digitizer and that it is easily
accessible.
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Labels
Product Identification
General
Product Identification
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General
Always take into account the markings and labels provided on the inside and
outside of the machine. A brief overview of these markings and labels and
their meaning is given below.
Caution hot:
Keep hands clear from the erasure unit.
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CAUTION! CUIDADO!
VORSICHT ! ATTENTION!
CLASS 1 LASER PRODUCT
LASERSTRAHLUNG KLASSE 3B: FAISCEAU LASER CLASSE 3B:
WENN ABDECKUNG GEÖFFNET QUAND CAPOT OUVERT ÉVITER
APPAREIL A LASER DE CLASSE 1
NICHT DEM STRAHL AUSSETZEN! DE S´EXPOSER AU RAYÓN!
LASERKLASSE 1
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3 Wipe the exterior of the digitizer with a clean, soft, damp cloth. Use a mild soap
or detergent if required but never use ammonia based cleaner.
3 Wipe the touch panel of the digitizer with a clean, soft, damp cloth. Use a com-
mercially available screen cleaner for monitors to clean the touch panel.
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4 Pull out the cleaning brush until you feel the stop position and put it back in the
digitizer.
Repeat this action 5 times.
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4 Open the right side door and locate the air-filter element inside the door open-
ing.
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5 Release the 2 clamps (1) to be able to remove the air filter frame (2).
1 3 2
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8 Mount the air-filter element inside the rights side door as illustrated below.
Note: Mind the air flow arrows imprinted on the air filter when positioning
the air-filter inside the door. The air flow arrows should always point to the
inside of the machine.
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Safety Directions
WARNING: The user must strictly observe all warnings, cautions,
notes and safety markings within this document and on the
product.
WARNING: The user must be aware that any error (crash / lock
up) leading to an image processing failure can cause loss of
diagnostic information.
Caution: The following actions may lead to serious risk of injury and
damage to the equipment as well as making the warranty void:
Changes, additions or maintenance to the Agfa products carried out
by persons without appropriate qualifications and certified train-
ing.
Using unapproved spare parts.
Note: To avoid images being lost due to a power failure, the workstation
and the digitizer can be connected to an uninterruptible power supply
(UPS) or an institutional standby generator.
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Only service personnel with certified Agfa training must make repairs. Only
authorized service personnel must make changes to the digitizer.
If there is any visible damage to the machine casing, do not start nor use the
digitizer.
Do not apply excessive shock or vibration to the digitizer during operation. This
may decrease the image quality. Neither should the device be moved during
operation.
Switch off the digitizer before performing any maintenance work or repairs.
Disconnect the digitizer from the mains before making repairs or performing
any maintenance activities during which live electrical components may be
exposed.
As is the case for all technical devices, the digitizer must be operated, cared for
and serviced correctly.
If you do not operate the digitizer correctly or if you do not have it serviced cor-
rectly, Agfa is not liable for resulting disturbances, damages or injuries.
Note: The DX-M only supports one Mammo plate type at a time. It has to be
decided to use either HM5.x detectors or MM3.xR plates and cassettes.
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The digitizer complies with the EN 60601-1 and UL 60601-1 standards for Med-
ical Electrical Equipment. This means that, although it is absolutely safe,
patients may not come in direct contact with the equipment. Therefore the
operator console must be placed outside a radius of 1.5 m (EN) or 1,83m (UL)
around the patient (according to the local valid regulation).
h= 2.5 m
(2.29 m*)
Patient environment
Perform no other operations on the digitizer than those described in this docu-
ment.
Switch the system off before moving it. When reaching the new position, fix the
digitizer in place and switch the system on again.
The digitizer is suitable for use in all establishments other than domestic, and
may be used in domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used for
domestic purposes, provided the warning concerning radio interference in the
paragraph ‘Safety Directions’ is heeded.
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Quality Control
Regular Quality Control has to be applied according the local regulations. If
no specific regulations are valid, a regular quality control applied with the
Agfa Auto QC² tool at least once a month is required to maintain a safe and
effective system.
For Mammography, constant quality control can be applied with the Agfa
Auto QC Mammo tool or with the “Routine Quality Control Tests for Full Field
Digital Mammography Systems” document, created by the NHSBSP (National
Health Service Breast Screening Program, UK).
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2 Getting Started with the
DX-G/DX-M
This chapter explains how to perform the first basic actions on the digitizer.
This chapter covers the following topics:
❑ Basic Features
❑ The User Interface
❑ Starting the Digitizer
❑ Basic Workflow (Scanning Images)
❑ Stopping the digitizer
DX-G/DX-M
Basic Features
DX-G/DX-M Features.
Operating Modes.
DX-G/DX-M Features
The digitizer reads out the latent X-ray images on image plates and sends
them to the workstation.
The digitizer has an input and output buffer for 5 cassettes. Consecutively on
each cassette in the buffer, the digitizer:
• takes the cassette from the input buffer in the digitizer.
• locks the cassette containing the image plate in the cassette slot,
• removes the image plate from the cassette,
• scans the image plate,
• converts the information of the latent image to digital data,
• erases the image plate and re-inserts it into the cassette,
• gives the image plate ID data the status 'erased',
• unlocks the cassette,
• transmits the digital image data to the workstation.
• pushes the processed cassette into the output buffer.
• permits re-routing of images to another workstation (limited demographic
data of the image).
The digitizer permits re-erasing an image plate before reusing it. In specific
cases, this is necessary to prevent ghost images caused by previous exposures or
scattered radiation from interfering with the image of interest.
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Operating Modes
The digitizer can be operated in two modes:
Operator Mode
Service Mode
Operator Mode
The operator mode groups all basic functions which are aimed at
radiographers:
• Re-erasing an image plate.
• Rerouting of images.
• Retrieving information with the information button.
• Changing touch panel properties (brightness and loudness of beeper).
All functions of the operator mode are described in this manual.
Service Mode
The service mode functions are reserved for trained service personnel. They
are password protected, and they are described in a separate document.
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Status Indicator
The indicator informs the user by light signals about the status of the digitizer
(e.g. image plate erasing cycle progress, operational indications such as warm
up,...). It is positioned at the front of the digitizer, so that it is visible from a
distance.
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1 Make sure the digitizer is connected to a workstation and that the workstation
is running the appropriate NX Software.
2 Make sure that the power plug is plugged into the socket.
3 Remove cassettes from the input buffer and input slot of the digitizer.
main switch
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If the digitizer has completed the self-test successfully, the digitizer enters the opera-
tor mode and the status indicator is continuously lighting up in green. The Standby
screen is shown:
Note: The brightness of the touch panel is temporarily reduced after not
being used for a while.
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Workflow:
3 Put the cassettes with the exposed and identified image plates in the input
buffer on the left side of the digitizer.
There can be up to five cassettes in the input buffer.
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6 Take the processed cassettes from the output buffer on the right side.
When the digitizer has finished, the status indicator is continuously lighting up in
green.
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Switching Off.
Switching Off
It is recommended to switch off the digitizer at the end of the day.
Note: Only switch off the digitizer if you do not intend to digitize emergency
image plates overnight. Switching on the digitizer takes approximately
3 minutes. During this time emergency digitizing is not possible!
To switch off, press the main switch to the Off (“0”) position.
main switch
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3 Operating DX-G/DX-M
This chapter provides information about functions that are available in operator
mode. Finally you will find some preventive maintenance and troubleshooting
guidelines.
This chapter covers the following topics:
GenRad: If the image plate has not been used for more than 48 hours.
Mammography: If the image plate has not been used for more than 24 hours.
2 Press the Erase button on the touch panel at the front side of the digitizer.
Erase button
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3 Put the cassettes containing the image plate on the cassette buffer [1] of the
digitizer as shown below.
Make sure to insert the cassette with the black (tube) side to the front and with the
shutter opening mechanism and the locking mechanism down, towards the cassette
slot.
4 Remove the cassette with the erased image plates from the cassette output
buffer.
Note: To re-erase an image plate, you must push the Erase button at the
front side before you insert the cassette. After that, you have 10 seconds to
enter a cassette. If you do not, the digitizer returns to the standby mode.
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Re-routing of an Image
Normally, an image is sent to the workstation where it was identified. But in
case of transmission problems, the image can be rerouted on the digitizer and
sent to an alternative workstation.
To reroute an image
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Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT
1 2 3
1. Image UID.
2. Workstation.
3. Status: T - Transmitting (the digitizer is busy transmitting the image) / W - Warning (the image
transmission has failed; manual re-transmission to a new workstation necessary) / Q - Queued
(the image is in the transmission queue; a manual transmission to another workstation is possi-
ble).
Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT
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VAM1254
MORLS234
PREVIEWSTAT
MORWF452
MORWF475
HOUSE M.D.
E.R.
GRACE ANATOMY
AGFA
UZA 452
MY OFFICE
4 Select the new workstation and confirm by clicking the Confirm button.
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Configuration button
Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT
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Configuration button
Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT
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3 In the Brightness section on the lower part of the Configuration window, use
the + or - buttons to adjust the brightness.
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Information button
The Information window appears, showing the IP Address, Name, Software version
and name of the primary NX workstation:
Confirmation button
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4 Collect all cables together to prevent them from being crushed when moving
the digitizer.
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7 Take the tool from the tool box at the inside of the right door.
8 Insert the tool in the opening and turn the screw counterclockwise, until the
digitizer is lifted up approximately 1,5-2 cm, until you encounter resistance.
1,5 - 2 cm
0.59 - 0.78 inch
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10 Once on the desired site, turn the screw clockwise until the digitizer is fixed on
the ground and you encounter resistance.
Now the digitizer is ready for operation.
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Proceed as follows:
2 Contact immediately your Agfa certified service engineer for more information.
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Proceed as follows:
1 Put the cassettes with the exposed and identified image plates wrongly in the
input buffer on the left side of the digitizer.
2 As a result, the digitizer moves the cassette into the intermediate position and
the following error message appears.
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Appendix
DX-G/DX-M
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A Equipment Information
Sheet
This appendix covers the following topic:
❑ Specifications
❑ Pixel Matrix Size
DX-G/DX-M
Specifications
Dimensions
Max. Height 48.4 inch
Max Floor space WxD 660 mm x 510 mm
(26.0 inch x 20.1 inch)
Max Projected Floor space WxD 1150 mm x 510 mm
(45.3 inch x 20.1 inch)
Weight
Unpacked approximately 180.0 kg (396.8 lb)
Buffer
Input/output cassette buffer 5 cassettes
Integrated data buffer If the connection to the workstation is inter-
rupted (e.g. workstation is shut off), the digi-
tizer will finish actual scanning-job and
temporary store the image until the connec-
tion to the NX workstation is re-established. A
new cassette will only be accepted if the previ-
ous transmission job has been finished.
Greyscale resolution
Output to workstation 16 bits/pixel square root compressed
Electrical connection
Operating voltage Autosensing power supply from: 100 V to
240 V, AC +/- 10%
Mains fuse protection Europe: 16 A
USA & Japan: 15 A
Mains frequency 50/60 Hz
Network connectivity
Ethernet connector
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•Standby 87 W
•Standby 92 W
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B Technical Documentation
This appendix contains technical information. It is only available in English.
❑ Compliance
❑ Connectivity
❑ Environmental Protection
❑ Remarks for HF-emission and immunity
DX-G/DX-M
Compliance
Certificates
Europe USA/Canada
Laser
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Harmonization
This document has been prepared to comply with the Study Group 1 guidance
document of the Global Harmonization Task Force (GHTF) (www.ghtf.org).
To assist development of a consistent, harmonized definition for a medical
device that could be used within a global regulatory model would offer
significant benefits to the manufacturer, user, patient or consumer, and to
Regulatory Authorities and support global convergence of regulatory systems.
The IECEE CB Scheme is the world's first truly international system for
acceptance of test reports dealing with the safety of electrical and electronic
products. It is a multilateral agreement among participating countries and
certification organizations. Agfa has produced a CB test report and claims
national certification in all other member countries of the CB Scheme.
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Connectivity
The digitizer is connected to one or more NX workstations via an ethernet
connection and uses a dedicated protocol to communicate with the
workstation.
Environmental Protection
WEEE end user information
On August 13, 2005, the European Directive on Waste Electrical and
Electronic Equipment (WEEE) 2002/96/EC, amended by Directive 2003/
108/EC came into force.
Battery Notice
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REMARK 1: The higher value will apply at 80 MHz and 800 MHz.
REMARK 2: These Guidelines may not apply to all situations. The dispersion of electromagnetic
waves is influenced by absorption and reflections from buildings, objects and
people.
a.The field strength of stationary transmitters, such as base stations of radio telephones, mobile
broadcasts for rural areas, amateur stations, and AM and FM radio transmitters, cannot be precisely
predetermined theoretically. An investigation of the location is recommended, to ascertain the elec-
tromagnetic environment as a result of stationary high frequency transmitters. If the field strength
of the device exceeds the level of agreement given above, the device must be observed with regard
to its normal operation at each place of use. In case of unusual performance characteristics, it can be
necessary to take additional measures, such as the re-orientation of the device, for example.
b.The field strength will be lower than 3 V/m above the frequency range from 150 kHz to 80 MHz.
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The distance can be determined through the equation for each respective column.
P is the rated power of the transmitter in watts (W) according to the manufacturer infor-
mation on the transmitter, only for transmitters where the rated power is not mentioned
in the above table.
REMARK 1 : An additional factor of 10/3 has been used to calculate the recommended
protective distance of transmitters in the frequency range from 80 MHz to 2.5 GHz, to
reduce the probability that mobile portable communication equipment unintentionally
brought into the area of the patients will lead to a disruption.
REMARK 2 : These Guidelines may not be relevant in all situations. The dispersion of
electromagnetic waves is influenced by absorption and reflections from buildings,
objects and people.
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Printed in Belgium
Published by Agfa HealthCare N.V., B-2640 Mortsel-Belgium
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