AGFA CR 35-X User manual

CR 35-X
User Manual
4454C EN 2013-05-14

24454C EN 2013-05-14
CR 35-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 35-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: 2013-05-14
0413

3
4454C EN 2013-05-14
CR 35-X DIGITIZER
Table of contents
Chapter 1: Introducing the CR 35-X ..................................................................5
CR 35-X intended use ...........................................................................................6
CR 35-X intended user..........................................................................................7
CR 35-X features...................................................................................................8
Warnings, Cautions and Notes .............................................................................9
Equipment Classification ...................................................................................10
Training ..............................................................................................................11
Product Complaints............................................................................................12
Safety precautions..............................................................................................13
Safety compliance ..............................................................................................18
Operating modes................................................................................................20
Configurations ...................................................................................................21
Maintenance.......................................................................................................24
Patient data security ..........................................................................................28
Environmental Protection..................................................................................29
The user interface ..............................................................................................30
Switching on the CR 35-X...................................................................................37
Switching off the CR 35-X ..................................................................................39
Chapter 2: Basic operation (‘Operator mode’)................................................41
Workflow ............................................................................................................42
Reading an image plate......................................................................................43
Reading an emergency image plate ...................................................................48
Re-erasing an image plate..................................................................................56
Reading the identification data of a cassette (Dedicated configuration only) .59
Changing the image plate type (Dedicated configuration only) .......................61
Chapter 3: Advanced operation (‘Key-operator mode’) ................................63
Survey of advanced functions (‘Key-operator mode’) .......................................64
Troubleshooting checklist..................................................................................65
Appendix A: Equipment information sheet ....................................................71
Appendix B: CR cassettes .................................................................................77
Appendix C: Remarks for HF-emission and immunity ..................................89

44454C EN 2013-05-14
CR 35-X DIGITIZER

Introducing the CR 35-X
This chapter draws attention to important safety precautions
and introduces the CR 35-X.
CR 35-X intended use
CR 35-X intended user
CR 35-X features
Warnings, Cautions and Notes
Equipment Classification
Training
Product Complaints
Safety precautions
Safety compliance
Operating modes
Configurations
Maintenance
Patient data security
Environmental Protection
The user interface
Switching on the CR 35-X
Switching off the CR 35-X
Chapter 1

64454C EN 2013-05-14CR 35-X intended use
CR 35-X DIGITIZER
CR 35-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. This device is intended to be operated in a
radiological environment by qualified staff.

7
4454C EN 2013-05-14 CR 35-X intended user
CR 35-X DIGITIZER
CR 35-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.

84454C EN 2013-05-14CR 35-X features
CR 35-X DIGITIZER
CR 35-X features
The CR 35-X is a Digitizer for image plates retaining latent X-ray images. It has
been developed by Agfa.
The CR 35-X accepts one cassette containing one image plate at a time. The
CR 35-X:
•takes the cassette containing the image plate from the cassette slot;
•removes the image plate from the cassette;
•scans the image plate;
•converts the information of the latent image to digital data;
•transmits the image data to the preview station;
•erases the image plate and re-inserts it into the cassette;
•gives the cassette ID data the status ‘erased’;
•returns the cassette;
•transmits the digital image data to an image processing station (‘destination’).
The CR 35-X allows assigning the status ‘emergency’ to an image.
The Digitizer gives an image priority to be sent to the image processing station if
the “Emergency key” was pressed before inserting an unidentified cassette.
The CR 35-X allows 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.
If the CR 35-X is dedicated to one ID Station, additional features are available:
•quickly identifying cassettes without the need for an ID Tablet;
•reading the identification data of a cassette;
•initializing a cassette, i.e. changing the image plate type.

9
4454C EN 2013-05-14 Warnings, Cautions and Notes
CR 35-X DIGITIZER
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.

10 4454C EN 2013-05-14Equipment Classification
CR 35-X DIGITIZER
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 25.
Disinfection See section “Cleaning and Disinfection” on page 25.
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.

11
4454C EN 2013-05-14 Training
CR 35-X DIGITIZER
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 35-X intended use
CR 35-X intended user
Safety precautions

12 4454C EN 2013-05-14Product Complaints
CR 35-X DIGITIZER
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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4454C EN 2013-05-14 Safety precautions
CR 35-X DIGITIZER
Safety precautions
General safety instructions
•For software and other technical platforms, and/or if valid in combination
with any consumable, which constitute, after installation, a system for the
interpretation of medical image data 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.
•Make sure that the CR 35-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 35-X.
•If there is any visible damage to the machine casing, do not start nor use
the
CR 35-X.
•If you want to connect the CR 35-X with other devices, components or
assemblies and if the technical data do not allow 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 35-X must be operated, cared
for and serviced correctly.
•If you don’t operate the CR 35-X correctly or if you don’t have it serviced
correctly, Agfa is not liable for resulting disturbances, damages or injuries.
•When installing the CR 35-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 35-X and that it is easily accessible.
•If you notice conspicuous noise or smoke, disconnect the CR 35-X
immediately.
•Check that the mains voltage is within the specified range of the self
adapting power supply of the machine.

14 4454C EN 2013-05-14Safety precautions
CR 35-X DIGITIZER
•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).
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.
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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4454C EN 2013-05-14 Safety precautions
CR 35-X DIGITIZER
Safety warning, indicating that the CR 35-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 35-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.
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

16 4454C EN 2013-05-14Safety precautions
CR 35-X DIGITIZER
• You can hurt your fingers if they are caught between the ADC Cassette and the
edge of the input slot. Insert the cassette in the input buffer as described in
‘Reading an image plate’ on page 43. At all times, keep your fingers clear of the
input slot. As soon as the cassette enters the CR 35-X, release it.
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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4454C EN 2013-05-14 Safety precautions
CR 35-X DIGITIZER
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 35-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 35-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.
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!

18 4454C EN 2013-05-14Safety compliance
CR 35-X DIGITIZER
Safety compliance
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.
Certificates
The CR 35-X complies with:
•the general safety standards:
IEC 60601-1: 2005,
EN 60601-1: 2006,
EN 60601-1 :1990 / A1:1993, A2:1995, A13:1996,
EN 60601-1-2 :2001,
IEC 60601-1 :1988/A1 :1991, A2 :1995,
IEC 60601-1-1 / EN 60601-1-1,
UL 60601-1:2003,
CAN / CSA C22.2 No.601.1-M90.
•the laser safety standards:
EN 60825-1: 1994 / A1:2002, A2:2001,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11,
ANSI Z 136-1980.
•EN ISO 14971:2000,
EN 1041:1998,
EN 980:1996/A1.
Note: The Digitizer is in compliance with the EG regulation 93/42/EEC
Directive (Medical Device).

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4454C EN 2013-05-14 Safety compliance
CR 35-X DIGITIZER
Radio Interference Suppression
It is hereby certified that the Digitizer has interference suppression according
to the EN 55011 Class B as well as the FCC Rules CR47 Part 15 Class B (North-
America).
Short-range devices
EN 300 330-2 V1.1.1
EN 301 489-03 V1.2.1
WARNING: For USA only:
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful
interference to radio communications. In case the equipment causes
harmful interference to other devices, see the User manual for help.

20 4454C EN 2013-05-14Operating modes
CR 35-X DIGITIZER
Operating modes
The CR 35-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;
•Reading the identification data of a cassette (Dedicated configuration only);
•Changing the image plate type (Dedicated configuration only).
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.