AGFA CR 85-X User manual

CR 85-X Digitizer
Reference manual
4451C EN 2013-04-30

24451C EN 2013-04-30
CR 85-X DIGITIZER
Manufacturer: Agfa HealthCare NV, Septestraat 27, B-2640 Mortsel - Belgium
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. CR 85-X is a trade-
mark 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 accu-
racy, completeness or usefulness of the information contained in this document and specifically disclaims war-
ranties 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 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 2013 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.
Date of the latest revision of the user manual: 2013-04-30
0413

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Table of contents
Chapter 1: Introducing the CR 85-X...............................................................5
CR 85-X intended use......................................................................................6
CR 85-X intended user ....................................................................................7
CR 85-X features .............................................................................................8
Warnings, Cautions and Notes .......................................................................9
Equipment Classification..............................................................................10
Training ........................................................................................................11
Product Complaints ......................................................................................12
Safety precautions ........................................................................................13
Safety compliance.........................................................................................19
Operating modes ..........................................................................................20
Maintenance .................................................................................................21
Cleaning and Disinfection ............................................................................22
Patient data security.....................................................................................23
Environmental Protection ............................................................................24
The user interface.........................................................................................25
Switching on the CR 85-X .............................................................................32
Switching off the CR 85-X.............................................................................34
Resetting the Digitizer..................................................................................35
Chapter 2: Basic operation (‘Operator mode’) ............................................37
Reading an image plate ................................................................................38
Reading an emergency image plate..............................................................40
Re-erasing an image plate ............................................................................43
Chapter 3: Advanced operation (‘Key-operator mode’) .............................47
Consulting the image transmission queue (‘Queue management’) ............48
Customizing the CR 85-X (‘Digitizer set-up’) ...............................................52
Setting the date and time .............................................................................58
Sending test images ......................................................................................59
Consulting information on the CR 85-X .......................................................60
Installing a new software version ................................................................64
Installing a new language.............................................................................69
Installing new customer parameters............................................................74
Saving the configuration data on a diskette (backup).................................80
Enabling/disabling fast preview ..................................................................83

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Chapter 4: Troubleshooting ...........................................................................85
General procedure in case of malfunction ...................................................86
Solving the ‘ERROR’ status...........................................................................87
Clearing cassette jams ..................................................................................89
Clearing image plate jams ............................................................................93
Appendix A: Equipment information sheet.................................................97
Specifications ...............................................................................................98
Appendix B: CR cassettes............................................................................103
Safety precautions ......................................................................................104
Description of the CR cassette....................................................................105
Cleaning the image plate............................................................................ 107
Cleaning the cassettes ................................................................................ 108
Technical specifications of the cassettes ....................................................109
Technical specifications of the image plates.............................................. 111
Appendix C: Remarks for HF-emission and immunity ............................. 113

Introducing the CR 85-X
This chapter draws attention to important safety precautions
and introduces the CR 85-X.
CR 85-X intended use
CR 85-X intended user
CR 85-X features
Warnings, Cautions and Notes
Equipment Classification
Training
Product Complaints
Safety precautions
Safety compliance
Operating modes
Maintenance
Cleaning and Disinfection
Patient data security
Environmental Protection
The user interface
Switching on the CR 85-X
Switching off the CR 85-X
Resetting the Digitizer
Chapter 1

64451C EN 2013-04-30Introducing the CR 85-X
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CR 85-X intended use
This device must only be used to scan exposed X-ray cassettes, containing an
erasable image plate (IP). This device is part of a system, consisting of X-ray
cassettes with erasable phosphor image plates, an identification station for
the cassettes and a workstation where 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.

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4451C EN 2013-04-30 Introducing the CR 85-X
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CR 85-X 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.

84451C EN 2013-04-30Introducing the CR 85-X
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CR 85-X features
The CR 85-X scans the exposed CR image plate, converts the information into
digital data and automatically transfers the image to the image processing
station for further processing and visualization.
The CR 85-X requires but little manual interaction. All you have to do, after
exposure and identification of the cassette, is to place it in the input buffer of
the CR 85-X. You can deposit up to 10 cassettes of different sizes
simultaneously in the input buffer. The Digitizer takes in the cassettes one by
one. The Digitizer reads the demographic data and routing information from
the memory chip in the cassette, opens the cassette, removes the image plate
and scans the latent image by means of a sweeping laser beam.
Once the image is digitized, the cassette is returned to the output buffer to be
used for new exposures. After a full Digitizer cycle, the plate has turned 180°
in the cassette.
Depending on the X-ray intensity which has affected the phosphor during the
exposure, more or less light will be emitted during laser scanning. The light is
converted into an electrical signal. This signal is then converted into a digital
bit stream. Once converted into digital form, the digitized image is
transferred to the image processing station for further processing and
visualization.
Further features of the CR 85-X include:
The CR 85-X permits assigning the status ‘emergency’ to an image. An emer-
gency image will be given priority by the image processing station.
The CR 85-X permits re-erasing an image plate before re-using it. In specific
cases, this is necessary to prevent ghost images caused by previous exposures or
stray radiation from interfering with the image of interest. You can erase a
batch of up to 9 image plates.

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Warnings, Cautions and Notes
The following samples show how warnings, cautions, instructions and notes
appear in this document. The text explains their intended use.
WARNING: Warnings are directions which, if they are not followed,
can cause serious or fatal injuries.
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.
Instruction : Follow the instruction literally to avoid the topic of warnings.
Note: Notes provide advice and highlight unusual points. A note is not
intended as an instruction.

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Equipment Classification
Class I Equipment 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 reli-
ability always plug the main power cord into an earthed
mains power outlet.
Type B Equipment Not applicable: The patient does not get in contact with
any part of the device.
Water Ingress This device does not have protection against ingress of
water.
Cleaning See section “Cleaning and Disinfection” on page 22.
Disinfection See section “Cleaning and Disinfection” on page 22.
Flammable Anes-
thetics
This device is not suitable for use in the presence of a flam-
mable anesthetic mixture with air, or in presence of a
flammable anesthetic mixture with oxygen or nitrous
oxide.
Continuous Opera-
tion
The unit is suitable to run continuously.

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Training
The user must have received adequate Agfa 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 should ensure that training is
received in accordance with local laws or regulations that have the force of
law. Your local Agfa representative can provide further information on
training.
The user must note the following information in the preliminary section of
this manual:
CR 85-X intended use
CR 85-X intended user
Equipment Classification

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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 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 [phone].

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Safety precautions
General safety instructions
•For software and other technical platforms, and/or in combination with
any consumable, which constitute, after installation, a system for the
interpretation of medical image data: such system is used by trained and
qualified professionals. It is the user's responsibility to ensure that image
quality, display quality, environmental lighting and other possible
distractions are consistent with the clinical application.
The user must be aware, that automatic collimation could possibly lead to
misinterpretation of the image.
•Make sure that the CR 85-X is constantly monitored in order to avoid
inappropriate handling, especially by children.
•Only trained service personnel must make repairs. Only authorized service
personnel must make changes to the CR 85-X.
•If there is any visible damage to the machine casing, do not start nor use
the CR 85-X.
•If you want to connect the CR 85-X with other devices, components or
assemblies and if the technical data do not permit determining whether the
combination with these devices, components or assemblies involves
hazards, you must consult the respective manufacturers to avoid danger for
operating personnel or the environment.
•Do not override or disconnect the integrated safety features.
•As is the case for all technical devices, the CR 85-X must be operated, cared
for and serviced correctly.
•If you do not operate the CR 85-X correctly or if you do not have it serviced
correctly, Agfa is not liable for resulting disturbances, damages or injuries.

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•When installing the CR 85-X, 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 CR 85-X and that it is easily accessible.
•If you notice conspicuous noise or smoke, disconnect the CR 85-X
immediately.
•Check that the mains voltage is within the specified range of the self
adapting power supply of the machine.
•The classification of this product according to the medical electrical
equipment standard IEC 60601-1 requires installation outside the patient
vicinity. For definition of patient vicinity see dimensions below.
R = 1.5 m/4.9 feet (EN 60601-1) or 1.83 m/6 feet (UL 60601-1).
h = 2.5 m/8.2 feet (EN 60601-1) or 2.29 m/7.5 feet (UL 60601-1).
WARNING: To avoid risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
Patient vicinity
Patient vicinity
R
h

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4451C EN 2013-04-30 Introducing the CR 85-X
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Markings and labels
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.
Safety warning, indicating that the CR 85-X manuals
should be consulted before making any connections to
other equipment. The use of accessory equipment not
complying with the equivalent safety requirements of this
Digitizer may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice of
accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity,
• Evidence that the safety certification of the accessory
equipment has been performed in accordance with the
appropriate IEC 601-1 and IEC 601-1-1 harmonized
national standard.
In addition all configurations must comply with the
medical electrical systems standard IEC 601-1-1. The party
that makes the connections acts as system configurator
and is responsible for complying with the systems
standard.
If required contact your local service organization.
In order to reduce the risk of electric shock, do not remove
any covers.
Caution hot:
Keep hands clear from the erasure unit.
Supplementary protective earth connector:
Provides a connection between the CR 85-X and the
potential equalization busbar of the electrical system as
found in medical environments. This plug should never be
unplugged before the power is turned off and the power
plug has been removed.
It is recommended to use the supplementary protective
earth connection as additional safety measure.
Intergrounding connector:
Provides a connection between the Digitizer and other
equipment which might exhibit minor ground potential
differences. These differences may degrade the quality of
communication between different equipment. Never
remove connections to this terminal.

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Protective earth (ground):
Provides a connection between the Digitizer and the
protective earth of the mains. Do not remove this
connection, because this will have a negative influence on
the leakage current.
Power On
Power Off
Note that the power cord has to be disconnected from the
wall outlet in order to disconnect the unit entirely from the
mains.
Precautions for use in USA only:
Make sure that the circuit is single-phase center-tapped, if
the Digitizer is connected to a 240 V/60 Hz source instead
of a 120 V/60 Hz source.
Type label
Date of manufacture
Manufacturer
Serial number
WEEE symbol, see section Environmental Protection
Device contains a transmitter module

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•You can hurt your fingers if they are caught between the CR cassette and
the edge of the input slot. Insert the cassette in the input buffer as
described in ‘Reading an image plate’ on page 38. At all times, keep your
fingers clear of the input slot. As soon as the CR 85-X takes in the cassette,
release it.
Safety instructions for laser products
The digitizer is a Class 1 Laser Product. It uses one laser diode of a 80 mW
type, classification class IIIb, wavelength 640-670 nm. The laser beam’s
deflection frequency is 120 1/s up to 170 1/s. The laser beam divergence is
12 mrad.
Under normal operating conditions - when both doors are closed - there can
be no laser radiation outside the CR 85-X. It is nonetheless imperative that the
local radiation safety regulations regarding the protection of staff against
scattered radiation are complied with, if the CR 85-X is located in the
immediate vicinity of an X-ray room.
Open the front left and right door only to solve cassette or image plate jams.
When you open either of the doors, the power supply of all critical
components is switched off automatically as a precaution.

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Observe the Caution instructions on the Optical module label:
WARNING: User interventions other than those described in this
manual can be hazardous with regard to laser radiation.
CAUTION!
CLASS 3B LASER RADIATION:
WHEN OPEN AVOID DIRECT
EXPOSURE TO THE BEAM!
CUIDADO!
RAYO LASER CLASE 3B:
EVITAR LA EXPOSICIÓN AL HAZ
CUANDO LA TAPA ESTÁ ABIERTA.
VORSICHT !
LASERSTRAHLUNG KLASSE 3B:
WENN ABDECKUNG GEÖFFNET
NICHT DEM STRAHL AUSSETZEN!
ATTENTION!
FAISCEAU LASER CLASSE 3B:
QUAND CAPOT OUVERT ÉVITER
DE S´EXPOSER AU RAYÓN!

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Safety compliance
The CR 85-X complies with:
•general safety standards:
IEC 60601-1: 2005,
EN 60601-1: 2006,
EN 60601-1:1990+A1:1993+A2:1995,
IEC 60601-1:1988+A1:1991+A2:1995,
IEC 60601-1-1 / EN 60601-1-1,
EN 60601-1-2,
UL 60601-1;
•laser safety standards:
EN 60825, DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11, ANSI Z 136-1980.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 60950 for data processing equipment
or IEC 60601-1 for medical equipment). Furthermore all configurations shall
comply with the valid version of the system standard IEC 60601-1-1
respectively IEC 60601-1:2005. 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
respectively IEC 60601-1:2005. If in doubt, consult your local service
organization.

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Operating modes
The CR 85-X can be operated in three modes: operator mode, key-operator
mode and service mode.
Operator mode
The operator mode groups all basic functions which are aimed at
radiographers:
•Reading an image plate;
•Reading an emergency image plate;
•Re-erasing an image plate.
A normal image plate is read automatically after it is placed in the CR 85-X
input buffer; the other functions of the operator mode can be accessed via the
keypad. All functions of the operator mode are described in Chapter 2, ‘Basic
operation (‘Operator mode’)’.
Key-operator mode
The key-operator mode groups advanced functions which are aimed at
technicians.
The key-operator mode can be accessed via the Key-operator key on the
keypad and is menu-driven. The key-operator functions are described in
Chapter 3, ‘Advanced operation (‘Key-operator mode’)’.
Service mode
The service mode functions are reserved for trained service personnel. They
are password protected.