AGFA Drystar 5302 Guide

HEALTHCARE
Global Services Organisation Technical
Documentation
printed in Germany 2005-09-09
Agfa Company Confidential
Order No.: DD+DIS150.05E
*1YZO6N1*
1 Piece YZO6N MA1
DRYSTAR 5302
Type 5366 / 100
1st Edition

This page is intentionally left blank to enable print out of even and odd pages on duplex printers.

HEALTHCARE
Global Services Organisation
Technical
Documentation
pprinted in Germany 2005-09-09
Agfa Company Confidential
Order No.: DD+DIS150.05E
*1YZO6N1*
1 Piece YZO6N MA1
DRYSTAR 5302
Type 5366/100
1
st Edition To order spare parts and Tel.: xx49 - (0)89 - 6207 – 3760
spare part assortments: Fax.: xx49 - (0)89 - 6207 – 7388
To order documentation: Tel.: xx49 - (0)89 - 6207 - 3553
Fax.: xx49 - (0)89 - 6207 - 7271
Caution:
This system uses high voltage. Please consider the respective safety regulations.
These instructions describe adjustments and routines which must only be
performed by qualified technical personnel.
Note:
Electrical repairs and connections must only be performed by a qualified
electrician.
Mechanical repairs and connections must only be performed by a qualified
technician.
CE Declaration:
The CE Declaration (CE Conformity) becomes invalid if the product is changed
without explicit consent of the manufacturer!
This applies to all parts, not only to safety elements.
AGFA-GEVAERT AG HE/Im - GSO I&P
Tegernseer Landstr. 161 D-81539 München

OVERVIEW
0. Order List
1. Controls, Connections and
Set Up Procedures
Pictograms and conventions for this documentation
This documentation uses certain conventions (pictograms, way of writing) for better
understanding and faster locating of the required information.
Explanation of the pictograms
2. Functional Description
3. Repair and Service
3.1 Machine specific safety and
repair information
3.2 Machine specific tools, software
tools and auxiliary equipment
3.3 Troubleshooting
3.4 Electrical and mechanical
codes, fuses, LED's
3.5 Replacement of parts
3.6 Adjustments and calibrations
3.7 Software menus, settings
3.8 Software-Releases, Patches
3.9 Frequently Asked Questions
Waiting time
Required tools
Removal
Installation
Mechanical adjustment
Electrical adjustment
Calibration
4. Reference and Circuit
Diagrams
5. Spare Parts List
6. Accessories
7. Field Modifications
High voltage !
Attention !
Info
Hint
Required spare part
Required time
8. Manufacturing Standard
Modifications Conventions
9. Maintenance Actions Way of writing Sample
10. Field Service Bulletins Action,
explanation Switch the machine on Switch the machine on
123
11. Installation Planning Action with the mouse or the
"Return" key <omni-cd.exe> Double-click the <omni-cd.exe> icon
12. Glossary and Key Word Index Required text input via the
keyboard vips Enter vips and click on
<Continue>

HEALTHCARE
Imaging Services Generic Safety Directions
Document No: DD+DIS238.06E
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3
07-2009 printed in Germany
Agfa Company Confidential
Document Node ID: 11849633
eq_generic_safety_directions_e_template_v01
Copyright © 2009 Agfa HealthCare N.V.
Generic Safety Directions
for HealthCare Imaging Products
►Purpose of this Document
This Generic Safety Directions document comprises the general safety relevant information including
relevant environmental and occupational safety instructions for the Service Engineer.
It is valid for all Agfa HealthCare Imaging Products and part of each Service Documentation as well as
Installation Planning document.
The latest version is available via MedNet, GSO Library path:
General Info => Agfa HealthCare => Publications => Service Manual
►Document History
Edition.
Revision Release Date Changes compared to previous Revision 1.2:
1.3 07-2009
•Updated table with laser classification to latest changes of the
corresponding standard. See section 3.3.
•Added section Environmental and occupational Safety Instructions.
See section 9.
•Added safety note concerning inroom installations of CR equipment
and corresponding X-ray shielding. See section 17.
•Added laser safety note and safety note concerning electrical checks
after repairs. See section 19.
•Added treatment for Lithium batteries in sections 19 and 21.
•Updated information concerning the recycling pass. See section 24.
►Referenced Documents
Document Title
Not applicable Not applicable

DD+DIS238.06E Generic Safety Directions
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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 2 of 28
►Manufacturer
Agfa HealthCare N.V.
Publisher
Agfa-Gevaert HealthCare GmbH
Tegernseer Landstraße 161
D - 81539 München
Germany
Copyright ©2009 Agfa HealthCare N.V.
All rights reserved.
Technical modifications reserved.
AGFA and the Agfa-Rhombus are trademarks of Agfa HealthCare N.V.
WARNING:
Improper operation or service activities may cause damage or injuries.
INSTRUCTION:
(1) Read the "Generic Safety Directions" document
(see MEDNET GSO => General Info => Agfa HealthCare => Publications =>
Service Manual) prior to attempting any operation, repair or maintenance task on the
equipment.
(2) Strictly observe all safety directions within the "Generic Safety Directions" and on
the product.
07-2009 Agfa Company Confidential

DD+DIS238.06E Generic Safety Directions
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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 3 of 28
07-2009 Agfa Company Confidential
20 SAFETY DIRECTIONS FOR REMOTE SERVICE ACTIVITIES ......................... 26
LIST OF CONTENTS
1DISCLAIMER......................................................................................................... 5
2USED ICONS ........................................................................................................ 6
3LABELS ................................................................................................................. 7
3.1 CE Mark................................................................................................... 7
3.2 System Labels ......................................................................................... 7
3.3 System Labels concerning Laser Radiation ............................................ 8
4PRODUCT COMPLAINTS .................................................................................. 10
5REFERENCES .................................................................................................... 10
6INTENDED USE.................................................................................................. 11
7INTENDED USER ............................................................................................... 11
8QUALIFICATIONS FOR OPERATION AND SERVICE TASKS.......................... 11
9ENVIRONMENTAL AND OCCUPATIONAL SAFETY INSTRUCTIONS............. 12
10 CONNECTIONS TO OTHER EQUIPMENT ........................................................ 13
11 ACCESSORIES AND SPARE PARTS................................................................ 14
12 COMPLIANCE..................................................................................................... 14
13 SAFETY DIRECTIONS FOR OPERATION......................................................... 17
14 RADIATION PROTECTION ................................................................................ 18
15 SAFETY DIRECTIONS FOR CLEANING AND DISINFECTION......................... 18
16 GENERAL SAFETY DIRECTIONS FOR SERVICE ACTIVITIES ....................... 19
17 SAFETY DIRECTIONS FOR INSTALLATION PLANNING ACTIVITIES ............ 20
18 SAFETY DIRECTIONS FOR INSTALLATION ACTIVITIES................................ 22
19 SAFETY DIRECTIONS FOR MAINTENANCE AND REPAIR ACTIVITIES ........ 23

DD+DIS238.06E Generic Safety Directions
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07-2009 Agfa Company Confidential
PARTS, ACCESSORIES AND DEVICES............................................................27
22
21 SAFETY DIRECTIONS FOR TRANSPORT AND SHIPMENT OF SPARE
SAFETY DIRECTIONS CONCERNING MODIFICATIONS.................................27
23 SAFETY DIRECTIONS CONCERNING HAZARDOUS MATERIALS .................27
24 RECYCLING ........................................................................................................27
25 WASTE DISPOSAL .............................................................................................28
26 ERASING PROTECTED HEALTH INFORMATION (PHI) ...................................28

DD+DIS238.06E Generic Safety Directions
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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 5 of 28
1 Disclaimer
The installation and service of equipment described herein is to be performed by qualified
personnel who are employed by Agfa HealthCare or one of its affiliates or who are
otherwise authorized by Agfa HealthCare or one of its affiliates to provide such services.
Fitters, engineers and other persons who are not employed by or otherwise directly
affiliated with or authorized by Agfa HealthCare or one of its affiliates are directed to
contact one of the local offices of Agfa HealthCare or one of its affiliates before attempting
installation or service procedures.
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.
Agfa HealthCare 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.
Agfa HealthCare 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 is not liable for resulting consequences, damages or injuries if you don’t
operate the product correctly or if you don’t have it serviced correctly.
Agfa HealthCare reserves the right to change the product, the characteristics and its
documentation without further notice to improve reliability, function or design.
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.
07-2009 Agfa Company Confidential

DD+DIS238.06E Generic Safety Directions
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2 Used Icons
Icon Name and Circumstances
CAUTION: Possible dangerous situation: Light injuries or
damage to the equipment described in the manual and/or
damage to any other equipment or goods and/or environmental
pollution can be the consequence.
WARNING: Dangerous situation: Potential serious injury to a
user, engineer, patient or any other person and possible
mistreatment of patients can be the consequence.
DANGER: Direct, immediate danger: Death or heavy injuries
can be the consequence.
INSTRUCTION:
If used in combination with the warning or caution sign: Indicates
a specific instruction, which if followed exactly, avoids the
subject of the warning or caution.
If used without warning or caution sign: Indicates an instruction
where it is important to follow literally as described.
IMPORTANT:
Highlights very important actions which have to be carried out to
prevent malfunction.
NOTE:
Indicates advice to facilitate the following step or action.
Highlights unusual points.
Indicates background information.
Can be used to explain or highlight displays of the
graphical user interface.
Is additional information without influence on the action or step!
07-2009 Agfa Company Confidential

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3 Labels
3.1 CE Mark
CE Mark
This product carries the CE Mark. The CE Declaration (CE Conformity)
becomes invalid if the product is changed without explicit consent of the
manufacturer! This applies to all parts, not only to safety elements.
3.2 System Labels
All system labels and software version number locations are referred to within this service
document in the appropriate section.
Enclosed an overview of common labels, according to ISO 3864.
This list is not complete.
Magnetic Field
Hot Surface Laser Beam
C&W
07-2009 Agfa Company Confidential
_
005.cdr
Ionizin
g
Radiation
Obstacles High Voltage Corrosive Liquid Hand Injuries

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3.3 System Labels concerning Laser Radiation
According to its classification, laser radiation can lead to eye and skin injuries.
Each laser source is classified from class 1 to class 4, based on standard
DIN EN 60825-1:2007.
The table below lists the meaning of the different laser classes. Note the detailed
instructions in the user manual and technical documentation.
Class # Meaning Example Label
Class 1: Not dangerous to the human eye, even
when using optical instruments. Can
nevertheless produce irritating effects,
especially with low ambient light
conditions.
CLASS 1 LASER PRODUCT
Class 1 M: Not dangerous to the human eye if no
optical instruments (magnifying glass or
binocular) are used.
Can nevertheless produce irritating
effects, especially with low ambient light
conditions.
CLASS 1M LASER PRODUCT
DO NOT VIEW DIRECTLY WITH
OPTICAL INSTRUMENTS
LASER RADIATION
Class 2: Dangerous to the human eye for
intentional staring into the beam.
Not dangerous for short term exposure
< 0,25 seconds.
Using optical instruments does not
increase the risk of eye injury.
Can even for short term exposure < 0,25
seconds produce dazzling and irritating
effects, especially with low ambient light
conditions.
CLASS 2 LASER PRODUCT
DO NOT STARE INTO BEAM
LASER RADIATION
07-2009 Agfa Company Confidential

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Class # Meaning Example Label
Class 2M: Dangerous to the human eye when
staring into the beam or when using
optical instruments (magnifying glass or
telescope). No hazard for short term
exposure < 0,25 seconds (aversion
response of the eye) without use of
optical instruments. Can produce
dazzling and irritating effects even for
short term exposure < 0,25 seconds,
especially at low ambient light conditions.
CLASS 2M LASER PRODUCT
LASER RADIATION
DO NOT STARE INTO THE BEAM
OR VIEW DIRECTLY WITH
OPTICAL INSTRUMENTS
Class 3R: Possibly dangerous to the human eye for
direct view into the beam.
Risks of an eye injury is increasing with
duration of exposure.
Can produce dazzling and irritating
effects, especially with low ambient light
conditions.
CLASS 3R LASER PRODUCT
LASER RADIATION
AVOID DIRECT EYE EXPOSURE
Class 3B: Normally dangerous to the human eye
for direct view into the beam.
Viewing diffuse reflections is normally not
dangerous.
Risk of small skin injuries or ignition of
explosive material if the power of the
laser beam is close to the upper limits of
class 3 B.
CLASS 3B LASER PRODUCT
LASER RADIATION
AVOID EXPOSURE TO BEAM
Class 4: Dangerous to the human eye for direct
view into the beam or viewing diffuse
reflections.
Very often class 4 lasers also implicate a
fire hazard.
CLASS 4 LASER PRODUCT
LASER RADIATION
AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED
RADIATION
07-2009 Agfa Company Confidential

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07-2009 Agfa Company Confidential
4 Product Complaints
Any service person who has any complaints or has experienced any dissatisfaction in the
quality, durability, reliability, safety, effectiveness or performance of this product must
notify Agfa HealthCare by the Agfa HealthCare complaint procedure.
If the product malfunctions and may have caused or contributed to a serious injury of a
patient or an accident or if there are any hazards which may cause an accident
Agfa HealthCare 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 – Gevaert N.V.
Septestraat 27
2640 Mortsel, Belgium.
Fax [phone]
5 References
Technical Documentation is available via MedNet (PDF) and your local Agfa HealthCare
support organisation (Paper).
Access to MedNet:
IntraNet: http://docs.agfanet/bu/mi/mednet/mednetcso.nsf
ExtraNet: http://extranet.agfa.com/bu/mi/mednet/mednetcso.nsf

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07-2009 Agfa Company Confidential
6 Intended Use
This Agfa HealthCare product should only be operated in a hospital or clinical radiological
environment by qualified staff.
It must only be operated according to its specifications and its intended use. Any
operation not corresponding to the specifications or intended use may result in hazards,
which in turn may lead to serious injuries or fatal accidents (for example electric shocks).
AGFA will not assume any liability whatsoever in these cases.
Make sure that the product is constantly monitored in order to avoid inappropriate
handling, especially by children.
The product must only be installed and put into operation under the specified conditions.
7 Intended User
This manual is written for Agfa trained Field Service Engineers and Clinical Application
Specialists, trained users of Agfa HealthCare products and trained diagnostic X–Ray
clinical personnel who have received proper training. Users are considered as the persons
who handle the equipment as well as the persons having authority over the equipment.
8 Qualifications for Operation and Service Tasks
This Technical Documentation describes adjustments and routines which must only to be
performed by qualified technical personnel.
The Agfa (trained) Field Service Engineers and Clinical Application Specialists must have
received adequate Agfa HealthCare training on the safe and effective use of the product
and applicable environmental and occupational safety matters before attempting to work
with it. Training requirements may vary from country to country.
Agfa (trained) Field Service Engineers and Clinical Application Specialists must make
sure that training is received in accordance with local laws or regulations that have the
force of law.
Your local Agfa HealthCare representative can provide further information on training.

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07-2009 Agfa Company Confidential
9 Environmental and occupational Safety Instructions
Each Agfa (trained) Field Service Engineer and Clinical Application Specialist:
•Must make his or her personal contribution to improve safety and protect the
environment.
•When working on a customers site, has a duty to take reasonable care to avoid injury
to himself or herself or to others who may be affected by their acts or omissions.
•Is obligated to adhere strictly to regulations and instructions.
•Shall familiarise himself or herself with the provisions of the Agfa Healthcare
Health, Safety and Environment Policy and any specific rules or procedures relating to
occupational safety at work and the protection of the environment.
•Shall promptly report any near misses, accidents, incidents or dangerous occurrences
to their line manager and co-operate fully in any investigation.
•Shall co-operate with company management on matters relating to
health, safety and environment and, where appropriate, discuss with and / or assist
their manager in resolving matters relating to health, safety and environment.
•Shall ensure that any company equipment issued to them, or, for which they are
responsible, is correctly used and properly maintained.
•Shall wear protective equipment whenever instructed or if it is recommended to do so.
•Shall be responsible for good housekeeping in the area in which he or she is working.
•Shall report situations, which could put them at risk, on either company or
customers' premises, to their manager or supervisor; and, if warranted, directly and in
confidence, to the Health and Safety Co-ordinator, Global HSE Manager, or ultimately
to the Managing Director.
•Shall report any injuries, diseases or dangerous occurrences to his or her line
manager.
•Shall report any accidents, incidents or near misses to his or her line manager.
•Shall report any situation of which he or she is aware that is potentially dangerous.
•Shall comply with any health surveillance procedure instituted for his or her benefit or
for compliance with regulations.

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10 Connections to other Equipment
Agfa HealthCare equipment must only be used in combination with other Agfa HealthCare
equipment or components if these are expressly recognized by Agfa HealthCare as
compatible. A list of such equipment and components is available from Agfa HealthCare
service on request.
Changes or additions to the equipment must only be carried out by persons authorized to
do so by Agfa HealthCare. 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.
The Agfa HealthCare products are designed to communicate with other devices in the
hospital network using DICOM protocols.
Connections to other equipment:
Warning:
Accessory equipment not complying with the safety requirements of this product
may lead to a safety hazard.
INSTRUCTION:
Consult the Technical Documentation before making any connections to other equipment.
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 60601-1 and IEC 60601-1-1 harmonized
national standard.
In addition all configurations must comply with the medical electrical systems standard IEC
60601-1-1. The party that makes the connections acts as system Configurer and is
responsible for complying with the systems standard.
If required, contact your local service organization.
07-2009 Agfa Company Confidential

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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 14 of 28
11 Accessories and Spare Parts
Parts and accessories replacement:
WARNING:
Hazards may be introduced because of component failure or improper operation.
INSTRUCTION:
•Replace defective parts with Agfa HealthCare original spare parts.
•Use only tools and measuring instruments which are suitable for the procedure.
•Only approved Agfa HealthCare accessories must be used. For a list of compatible
accessories contact your local Agfa HealthCare organization or www.agfa.com.
12 Compliance
Directive for HealthCare Imaging Products:
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(OJ No L 169/1 of 1993-07-12)
•ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS The
products are designed and manufactured in such a way that, when used under the
conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of
users.
•ANNEX II - EC DECLARATION OF CONFORMITY: Full quality assurance system
ISO 13485
•ANNEX X - CLINICAL EVALUATION: The clinical evaluation follows a defined and
methodologically sound procedure.
07-2009 Agfa Company Confidential

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07-2009 Agfa Company Confidential
Applied Standards for HealthCare Imaging Products
•IEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
•ISO 14971:2000, Medical devices – Application of risk management to medical devices
•IEC 60601-1-2, It specifies the MANUFACTURER of the ME EQUIPMENT or ME
SYSTEM provides information to the RESPONSIBLE ORGANIZATION that is essential
in determining the suitability of the ME EQUIPMENT or ME SYSTEM for the
electromagnetic environment of use, and in managing the electromagnetic environment
of use to permit the ME EQUIPMENT or ME SYSTEM to maintain BASIC SAFETY and
provide its ESSENTIAL PERFORMANCE without disturbing other equipment.
Additional standards for documentation:
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presentation
Harmonization:
Global Harmonization Task Force (GHTF) www.ghtf.org/
This document has been prepared to comply with 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 and would offer significant benefits to the manufacturer, user,
patient or consumer, and to Regulatory Authorities and support global convergence of
regulatory systems.
IECEE CB SCHEME
The IECEE CB (Certification Body) 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.
Details see www.iecee.org

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Radiation of radio frequency:
CAUTION: For USA only:
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the service manual, may cause interference
to radio communication.
Note:
This product has been tested and found to comply with the limits for a Class A
computing device pursuant to Subpart B of Part 15 of FCC Rules, which are designed to
provide reasonable protection against such interference when operated in a commercial
environment.
Operation of this equipment in a residential area is likely to cause interference.
The user will be required to take all necessary measures to correct the interference at
his own expense.
07-2009 Agfa Company Confidential