Agfa NV 5367A Drystar Axys /xxx Medical tabletop printer User Manual manual part 1

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Drystar AXYS
User Manual
2852 A EN 20070205
DRYSTAR AXYS
0413
No parts of this document may be reproduced, copied, adapted or transmitted in any form or by any means without the written permission of Agfa-Gevaert N.V.
Agfa-Gevaert 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. Agfa-Gevaert 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-Gevaert N.V. reserves the right to make changes to this document without prior notice.
Agfa-Gevaert N.V., Septestraat 27, B-2640 Mortsel, Belgium.
Windows® and Windows® XP are trademarks of Microsoft Corporation.
The Drystar AXYS uses software developed by the Apache Software Foundation (http://www.apache.org/
licenses/LICENSE).
Drystar AXYS is a trademark of Agfa-Gevaert N.V., Belgium.
Agfa and Agfa-Rhombus are trademarks of Agfa-Gevaert N.V., Belgium or one of its affiliates.
For more information on Agfa products and Agfa HealthCare products, please visit www.agfa.com.
© Agfa-Gevaert N.V. 2007.
2852 A EN 20070205
DRYSTAR AXYS
Introduction .......................................................................................7
Introduction to this Manual................................................................................ 8
Scope of this Manual ............................................................................................ 8
Warnings, Cautions, Instructions and Notes ......................................................... 9
Disclaimer.......................................................................................................... 10
Introduction to Drystar AXYS ........................................................................... 11
Intended Use...................................................................................................... 11
Intended User .................................................................................................... 11
Configuration .................................................................................................... 12
Main Components ......................................................................................... 12
Functional Description .................................................................................. 13
Film Formats ................................................................................................. 14
Operation Controls ............................................................................................ 15
Overview of user interface controls................................................................ 15
The status indicator LED................................................................................ 16
The control buttons ....................................................................................... 16
System Documentation ...................................................................................... 17
Options and Accessories ..................................................................................... 18
Training ............................................................................................................. 20
Product Complaints............................................................................................ 20
Compatibility ..................................................................................................... 21
Compliance........................................................................................................ 22
Directive........................................................................................................ 22
Quality Control.............................................................................................. 22
Standards ...................................................................................................... 23
Additional standards for documentation........................................................ 25
Harmonization .............................................................................................. 25
Performance ...................................................................................................... 26
Connectivity....................................................................................................... 27
Network features ........................................................................................... 27
Network configuration .................................................................................. 28
Installation ........................................................................................................ 29
Connections .................................................................................................. 30
Transport after installation ............................................................................ 31
Changing the film format of the trays ............................................................ 32
Messages............................................................................................................ 35
Labels ................................................................................................................ 36
Patient Data Security ......................................................................................... 39
Node authentication, certificates and Certification Authority ........................ 39
Maintenance ...................................................................................................... 40
2852 A EN 20070205
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Environmental protection................................................................................... 41
Waste Disposal and Environmental Regulations ............................................. 41
Restriction of the Use of Certain Hazardous Substances (RoHS) ....................42
Safety Directions ................................................................................................43
Getting Started ............................................................................... 45
Drystar AXYS Basic Features ............................................................................ 46
Switching on the Drystar AXYS ........................................................................ 48
Drystar AXYS Basic Workflow .......................................................................... 50
Controlling the Working of the Drystar AXYS .....................................................50
Operator mode .............................................................................................. 51
Key-operator mode ........................................................................................ 51
Service mode................................................................................................. 51
Specialist mode .............................................................................................52
Administrator mode (also known as Security)................................................52
Working with the keypad....................................................................................53
The display.........................................................................................................55
General display features ................................................................................56
Operator mode .............................................................................................. 57
Key-operator mode ........................................................................................58
Data entry .....................................................................................................58
Audio signals......................................................................................................59
Working with Compact flash cards (CF-card)......................................................60
Cooling down the Drystar AXYS ....................................................................... 62
Switching off the Drystar AXYS ........................................................................ 63
Basic operation
(Operator mode) ...................................................................................... 65
Overview of operator functions........................................................................ 66
Managing the print queue .................................................................................67
Checking the print queue ................................................................................... 67
The local print queue screen ...............................................................................68
Pausing the print queue ................................................................................... 69
Viewing the film count info .............................................................................. 70
Viewing the printer status ................................................................................ 71
Deleting print jobs............................................................................................ 72
About Drystar AXYS consumables .................................................................... 73
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DRYSTAR AXYS
Labeling the input trays...................................................................................... 74
Loading films.................................................................................................... 76
When the Drystar AXYS is printing or calculating and an input tray is empty ...... 77
When the Drystar AXYS is in the ready state and an input tray is empty .............. 78
Film loading procedure ...................................................................................... 79
Checking the correct position of a film in the input tray...................................... 83
Advanced operation
(Key-operator mode) ...............................................................................85
Overview of key-operator functions ................................................................. 86
Quality Control for general radiography applications (DT 2 B & DT 2 C) ......... 87
Establishing the reference values and verifying image quality for general radiography applications (DT 2 B and DT 2 C)................................................................. 88
QC test image for general radiography applications (DT 2 B and DT 2 C) ....... 90
Establishing the daily operating reference density levels for general radiography
applications (DT 2 B and DT 2 C)................................................................... 91
Establishing the image geometry reference values for general radiography
applications (DT 2 B and DT 2 C)................................................................... 95
Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visibility for general radiography applications (DT 2 B and DT 2 C)..................... 96
Performing quality control (QC) tests for general radiography applications (DT 2 B
and DT 2 C)........................................................................................................ 98
Performing the daily QC test for general radiography applications (DT 2 B and
DT 2 C).......................................................................................................... 99
Performing the Weekly QC tests for general radiography applications (DT 2 B
and DT 2 C) ................................................................................................. 101
Performing the Annual QC tests for general radiography applications (DT 2 B
and DT 2 C) ................................................................................................. 103
Quality control for mammography application (DT 2 Mammo) (optional).... 104
Establishing the reference values and verifying image quality for mammography
application (DT 2 Mammo) (optional) ............................................................. 105
QC test image for mammography applications (DT 2 Mammo) (optional) ... 107
Establishing the daily operating reference density levels for mammography
application (DT 2 Mammo) (optional)......................................................... 108
Establishing the image geometry reference values for mammography application (DT 2 Mammo) (optional).................................................................... 112
Verifying Acceptable Spatial Resolution and Artifact Levels and Low Contrast
Visibility for mammography application (DT 2 Mammo) (optional)............. 113
Performing quality control (QC) tests for mammography application
(DT 2 Mammo) (optional) ............................................................................... 115
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DRYSTAR AXYS
Performing the daily QC test for mammography application (DT 2 Mammo)
(optional) .................................................................................................... 116
Performing the Weekly QC tests for mammography application (DT 2 Mammo)
(optional) .................................................................................................... 118
Performing the Annual QC tests for mammography application (DT 2 Mammo)
(optional) .................................................................................................... 120
Preventive maintenance schedule ...................................................................121
Safety guidelines .............................................................................................. 121
Cleaning the exterior...................................................................................... 122
Cleaning the print head.................................................................................. 123
Troubleshooting checklist ...............................................................................127
Clearing of film jams ...................................................................................... 129
Film input tray jams.......................................................................................... 130
Film transport jams (clearing from the top) ...................................................... 133
Unauthorized opening of the printer ................................................................ 136
Film identification problems ...........................................................................137
No identification code detected ........................................................................ 138
Invalid content of Film Identification tag ......................................................... 141
Film overrun from current pack........................................................................ 141
Equipment information sheet ....................................................143
Specifications ..................................................................................................144
Viewing the system info area on a film............................................................148
Quality Control Charts ................................................................149
Charts for general radiography QC ................................................................ 150
Charts for mammography QC (optional) ....................................................... 155
2852 A EN 20070205
1
Introduction
This chapter covers the following topics:
❑
Introduction to this Manual
❑
Introduction to Drystar AXYS
DRYSTAR AXYS
Introduction to this Manual
Scope of this Manual
This manual contains information for the safe and effective operation of AGFA
Healthcare products.
This manual contains all instructions for the key-operator or any other skilled
person, to work easily and correctly with the Drystar AXYS.
2852 A EN 20070205
DRYSTAR AXYS
Warnings, Cautions, Instructions 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 fatal or serious injuries to a user, engineer, patient or any
other person or can lead to a mistreatment.
Figure 1: Safety icons
The purpose of the safety icons shown above is to indicate at a glance the type of
warning or danger.
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: This sign is typically used in combination with the warning
sign when providing a specific instruction. If it is followed exactly, it
should avoid the subject of the warning
Note: Notes provide advice and highlight unusual points. A note is not
intended as an instruction.
2852 A EN 20070205
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Disclaimer
Agfa assumes no liability for use of this document if any unauthorized changes
to the content or format have been made.
Every care has been taken to ensure the accuracy of the information in this document. However, Agfa assumes no responsibility or liability for errors, inaccuracies, or omissions that may appear in this document.
Agfa reserves the right to change the product without further notice to improve
reliability, function or design. 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.
10
2852 A EN 20070205
DRYSTAR AXYS
Introduction to Drystar AXYS
Intended Use
The Drystar AXYS is a dry digital tabletop printer for producing medical diagnostic images. It can print multiple formats (8x10”, 10x12”, 11x14”, 14x14” and
14x17”) of blue-based (Drystar DT 2 B) and clear-based (Drystar DT 2 C) film
and offers crisp, dense grayscale images. The Drystar AXYS can be used for general radiography and optionally for the mammography application. It is
designed for high-throughput and for use as a central printer.
Intended User
This manual is written for trained users of Agfa products. Users are considered
as the persons who actually handle the equipment as well as the persons having
authority over the equipment. Before attempting to work with this equipment,
the user must read, understand, note and strictly observe all warnings, cautions
and safety markings on the equipment.
2852 A EN 20070205
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DRYSTAR AXYS
Configuration
Main Components
The figure below illustrates the main components of the printer
Figure 2: Front view
1. Top cover
2. Output tray
3. User interface (refer “Overview of user interface controls” on page 15
4. Input tray
12
2852 A EN 20070205
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Functional Description
The Drystar AXYS consists of two functional blocks: a controller and a print
engine.
Q The controller
The controller captures the incoming data and stores the image.
The controller composes the different images and generates the appropriate
print engine control signals.
Q The print engine
The print engine receives the image data from the controller, drives the film
through the device and produces black & white hardcopy prints.
The figure below illustrates how the film is transported through the printer
Figure 3: Film transport
1. Film pick up unit
2. Output module
3. Print head module
4. Drum
5. Film path
2852 A EN 20070205
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DRYSTAR AXYS
Film Formats
Multiple film formats (8x10”, 10x12”, 11x14”, 14x14” and 14x17”) can be used.
Any combination of two film formats can be used “online”. Both input trays can
be adjusted for all film formats.
14
2852 A EN 20070205
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Operation Controls
The Drystar AXYS interfaces with the user via the following controls:
Q Power/Reset button;
Q a keypad and a display;
Q a status indicator;
Q audio signals.
Overview of user interface controls
Figure 4: User interface controls
1. Power/Reset button
2. Display
3. Keypad
4. Status indicator LED
5. Film input trays
6. Film output tray
WARNING: Never try to open the printer when the Drystar AXYS is
printing a film. Always follow the instructions on the display!
2852 A EN 20070205
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DRYSTAR AXYS
The status indicator LED
On the right side of the display, an LED indicates the status of the Drystar AXYS.
Colour/Light
Status
Action
Green
Constant
Ready (stand-by)
Proceed
Blinking
Busy or in key-opertor
mode
Wait
Constant
Warning status
Blinking
Error status
Check the display for
messages.
Refer to “Checking the
status indicator LED”
on page 241 of the Reference manual.
Red
Table 1: Status indicator LED
The control buttons
One control button has been provided:
Power/Reset button
•
•
To power on or off the printer.
To reset the printer.
Table 2: Control buttons
WARNING: Do NOT press the Power/Reset button without first
following the procedure to stop printing when the Drystar AXYS is
printing a film. Refer to “Switching off the Drystar AXYS” on page 63
16
2852 A EN 20070205
DRYSTAR AXYS
System Documentation
The documentation shall be kept with the system for easy reference. Technical
documentation is available in the product service documentation that is available from your local support organisation.
The documentation consists of:
Q Reference Manual (English only), this document.
Q User Manual, document 2852.
Q Plug & Play Manual, document 2851 & 2855.
Q Mobile installation Kit, document 2854.
Q Packing slip, document 2850.
Q Documentation CD
2852 A EN 20070205
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DRYSTAR AXYS
Options and Accessories
Q ABC Ordering Codes
The table below lists the ordering codes for the Drystar AXYS and possible
options.
Description
ABC code
Remark
Drystar AXYS
EYZ4E
A#sharp technology is included
EY8RN
A#sharp technology is included
Mammo option
Drystar AXYS
for
The Drystar AXYS can be used for
printing mammography application
films. For this option, a license has to
be activated by an Agfa service technician. The feature comes with a QC procedure that complies with the NEMA
Standards Publication XR 23-2006.
For more information, refer to “Quality control for mammography application (DT 2 Mammo) (optional)” on
page 104.
Contact your local service organization for more information.
Cleaning roller tissue
EQU6Y
Mobile / Earthquake
provision
EX2DV
The installation kit allows you to use
the Drystar AXYS in a van, or to use it
in unstable environment. It contains
the necessary equipment to fix the
printer onto a table, and has provisions
for easy service access. The mobile/
earthquake installation kit is delivered
with the necessary mounting instructions.
No additional software for mobile/
earthquake use is required.
Table 3: ABC ordering codes
18
2852 A EN 20070205
DRYSTAR AXYS
Q Available Software codes
The table below lists the available software versions and the type of printer they
require.
Software version (SW)
Printer
1.60
Drystar AXYS RoHS compatible
Table 4: Software version
Q Consumables
The Drystar AXYS can handle DRYSTAR DT 2 B and DRYSTAR DT 2 C consumables (both are general radiography film types) in multiple formats (8x10” up
to 14x17”) and optionally DRYSTAR DT 2 Mammo (mammograpy film type)
consumables, available in the formats 8x10”, 10x12” and 11x14”.
2852 A EN 20070205
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DRYSTAR AXYS
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 must make sure 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:
Q Intended Use
Q Intended User
Q Safety Directions
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 are listed on
www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa- Fax +32 3 444 7094
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Compatibility
Drystar AXYS 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
practice and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Drystar AXYS is a Dicom printer and can therefore be connected to Agfa equipment and all modalities supporting Dicom. Although, to ensure optimal operation and image quality, Agfa has made the effort to test and release the
Drystar AXYS with most of modalities on the market. For the complete list or if
you want to check on a specific modality, contact your Agfa representative.
2852 A EN 20070205
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DRYSTAR AXYS
Compliance
This paragraph sums up the directives, standards and harmonization initiatives
Drystar AXYS complies with.
Directive
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ
No L 169/1 of 1993-07-12)
Q ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS
The devices 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.
Q ANNEX II - EC DECLARATION OF CONFORMITY
Full quality assurance system ISO 13485
Q ANNEX X - CLINICAL EVALUATION
The clinical evaluation follows a defined and methodologically sound procedure.
Quality Control
Q The Quality Control test procedure for general radiography applications (refer
to “Quality Control for general radiography applications (DT 2 B & DT 2 C)” on
page 87complies with the grayscale reproduction constancy test, according to
the international standard IEC 1223-2-4.
Q The Quality Control test procedure for the optional mammography application
(refer to “Quality control for mammography application (DT 2 Mammo)
(optional)” on page 104 ) complies with the NEMA Standards Publication XR
23-2006
22
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Standards
Q ISO 14971:2000, Medical devices - Application of risk management to medical
devices
Q IEC 60601-1-2 It specifies the manufacturer of the medical equipment or medical system. It also provides information to the responsible organization that is
essential in determining the suitability of the medical equipment or medical
system for the electromagnetic environment of use, and in managing the electromagnetic environment of use to permit the medical equipment or medical
system to maintain basic safety and provide its essential performance without
disturbing other equipment.
Q Seismic (earthquake) requirements
The printer meets the CA (Californian) requirements.
Safety standards
Q IEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
Q IEC 60601-1 + A1 + A2
Q EN 60601-1 + A1 + A2
Q UL 60601-1
Q CSA 22.2 No. 601.1-M90
Q GB4943-2001 (for CCC-Mark)
EMC
Q FCC Rules 47 CFR part 15 subpart B
Q IEC 60601-1-2
Q CISPR 11, class A
Q CISPR 22, class A
Q IEC 61000-4-3
2852 A EN 20070205
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DRYSTAR AXYS
Q IEC 61000-4-4
Q IEC 61000-4-5
Q IEC 61000-4-6
Q IEC 61000-3-2
Q IEC 61000-3-3
Q IEC 61000-4-11
Q ETSI 300330
Q GB9254-1998(Class A) (for CCC-Mark)
Q GB17625.1-2003 (for CCC-Mark)
Q USA: This equipment has been tested and found to comply with the limits for a
class A digital device, pursuant to part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used
in accordance with the Drystar AXYS Reference manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will
be required to correct the interference at its own expense. If required, contact
your local service organization.
Q Canada: This class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.
Q EC: This is a class A product. In a domestic environment this product may cause
radio interference in which case the user may be required to take adequate measures.
24
2852 A EN 20070205
DRYSTAR AXYS
Additional standards for documentation
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presentation
Harmonization
Q Global Harmonization Task Force (GHTF) www.ghtf.org
This document been has prepared to comply with Study Group 1 guidance document of the Global Harmonization Task Force (GHTF). 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.
Q IECEE CB SCHEME www.iecee.org
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.
2852 A EN 20070205
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DRYSTAR AXYS
Performance
Q The direct thermal printing system provides grayscale images with high quality:
508 pixels per inch resolution, each pixel with 12 bit contrast resolution and an
average density of 3.2 for general radiography applications and an average density of 3.8 for optional mammography application (measured with an X-Rite
densitometer).
Q Multiple film formats (8x10”, 10x12”, 11x14”, 14x14” and 14x17”) can be used.
Any combination of two film formats can be used “online”. Both input trays can
be adjusted for all film formats.
26
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Connectivity
The Drystar AXYS is a standard network printer. This means that you can just
plug it into the (existing) ethernet network without any additional options or
accessories. Drystar AXYS is also a native DICOM printer. Therefore the standard DICOM protocol can be used as network protocol, and again without any
additional options or accessories the printer will be able to process and print the
DICOM jobs.
Network features
Q The modular design offers optimal application functionality for your specific
networking requirements.
In a network configuration, the Drystar AXYS is fully compatible with all other
AGFA imaging system components, including the CR digitizers, CR workstations, image buffer components, Paxport and the entire line of Impax stations.
For more information, contact your Agfa representative
Q The modular design offers optimal application functionality for your specific
networking requirements.
Q The functionality of the Drystar AXYS is completely controlled via the network.
Q You can control the working of the Drystar AXYS via the local keypad or via a
remote PC with a functioning web browser.
2852 A EN 20070205
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DRYSTAR AXYS
Network configuration
Network
Images
Paxport
Modality
CR Workstation
Drystar AXYS
PACS
Example of Drystar AXYS in a network configuration
Figure 5:
Modality
Paxport
Drystar AXYS
Example of Drystar AXYS in a point-to-point configuration
Figure 6: Network configuration
* A Paxport is required if the modality is not a DICOM modality.
28
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Installation
Drystar AXYS installation and configuration is performed by Agfa. (A limited
number of configuration tasks can also be performed by the customer after an
Agfa training course has been provided.) Contact your local support organization for more information.
For more information about the installation, refer to the Drystar AXYS Plug &
Play installation manual and/or the Drystar AXYS Mobile Kit installation manual.
2852 A EN 20070205
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DRYSTAR AXYS
Connections
At the rear side of the printer, one slot and three connectors are available:
CF-card slot
To insert an external CF-card
for software installation, backup, etc.
Network connector
To connect to the hospital network.
Input/output connector
To connect a terminal PC (used
by the Service engineer).
Power connector
To connect the printer power
cord.
The figure below illustrates the back-to-back connections of the printer
Figure 7: Rear view
1. CF-card slot
2. Network
3. RS-232 =>Service PC
4. Power connection
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Transport after installation
The Drystar AXYS is quite compact, so moving the printer over a short distance if required - can be done in a convenient way.
Always keep in mind the following safety guidelines:
Note: Refer to “Safety Directions” on page 43.
WARNING: The Drystar AXYS should be transported by 3 persons
or if not possible with 2.
WARNING: The Drystar AXYS must only be transported with all
covers closed.
WARNING: Always lift the Drystar AXYS by gripping the handles,
situated at front, left and right side. Do not lift the Drystar AXYS
by the output tray.
WARNING: When transporting the Drystar AXYS, the stability and
the structure of the tabletop have to be taken into account.
The printer should not be placed on a soft surface, since this might
prevent appropriate ventilation and cause overheating.
Make sure the printer is placed on a stable, hard surface table.
Figure 8: Transport posibilities
2852 A EN 20070205
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DRYSTAR AXYS
Procedure:
Switch off the Drystar AXYS (refer to “Switching off the Drystar AXYS” on
page 63).
Disconnect the cables.
Move the Drystar AXYS to its destination (with 2, preferably 3 persons!).
Reconnect the cables.
Switch Drystar AXYS on (refer to “Switching on the Drystar AXYS” on page 48).
Changing the film format of the trays
The key-operator can adjust the film size setting of both input trays (8x10” up to
14x17” film sizes).
Before a different film format can be loaded, the film format settings of the tray
has to be changed. After this modification, the ‘film format’ parameter is automatically read from the Film Identification tag when the new film pack is
loaded.
Note: Never load another film format when the input tray is not empty.
Intermediate changing of film formats increases the risk for dust, which
can damage the thermal print head (TPH).
Note: The system performs an automatic calibration when the film format
has been changed.
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Proceed as follows to perform the mechanical modification:
Make sure that the printer is in ‘Ready’ mode.
Open the input tray you want to adapt and remove eventually loaded films.
Locate the correct tab position for the desired film format.
17"
14"
12"
11"
8"
10"
14"
10” and 14” width
tab
Note: Note that there is a screw to secure the position of the 10” and 14”
width format tabs. The format tabs positioned in the depth are not
provided with a screw.
2852 A EN 20070205
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DRYSTAR AXYS
34
Remove the film position tab.
Put the filmion tab in place and push it down until it locks. Tighten the screws
of the width format tabs.
Load a new film pack. Refer to “Loading films” on page 76.
2852 A EN 20070205
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Messages
Under certain conditions the red LED on the right side of the display lits up and
a warning or error message is shown on the display. This message informs the
user that either a problem has occurred or that a requested action cannot be
performed.
Colour/Light
Status
Action
Red
Constant
Warning status
Blinking
Error status
Check the display for
messages. Refer to
“Checking the status
indicator LED” on
page 241 of the Reference manual.
Table 5: Red status indicator LED
The user must read these messages carefully. It will provide information on
what to do from then on. This will be either performing an action to resolve the
problem or to contact the Agfa service organization. Details on the contents of
messages can be found in the service documentation which is available to Agfa
service personnel.
2852 A EN 20070205
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DRYSTAR AXYS
Labels
[The following samples illustrate some of the warning labels (ISO 3864 Safety
Signs define the design principles for international safety signs) that may
appear on the medical equipment.]
Symbol
Explanation
Radiation Warning
Indicates the possibility of increased levels of radiation.
Figure 9: Radiation Warning
High Voltage Warning
Indicates the presence of high voltage.
Figure 10: High Voltage
Warning
Laser Warning
Indicates the presence of a laser device.
Figure 11: Laser Warning
Hot Surface Warning
Indicates that touching the part indicated can
cause burns.
Figure 12: Hot Surface Warning
Do not sit Warning
Indicates that sitting on a component can cause
damage to the equipment.
Figure 13: Do not sit Warning
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2852 A EN 20070205
DRYSTAR AXYS
Always take into account the markings provided on the inside and outside of
the printer. A brief overview of these markings and their meaning is given
below.
Symbol
Explanation
Keep hands clear from the thermal print head.
Figure 14: Caution hot:
In order to reduce the risk of electric shock, do not
remove any covers.
Figure 15: High voltage
Indicates that the Drystar AXYS complies with the limits for type B equipment.
Figure 16: Type B
equipment:
Figure 17: Supplementa
ry protective earth
connector:
Figure 18: Intergroundi
ng connector:
Figure 19: Protective
earth (ground):
Provides a connection between the Drystar AXYS and
the potential equalization bus bar 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.
Provides a connection between the printer 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.
Provides a connection between the printer and the
protective earth of the mains. Do not remove this connection, because this will have a negative influence on
the leakage current.
Note that the power cord has to be disconnected from
the wall outlet in order to disconnect the unit entirely
from the mains.
Figure 20: Power button
2852 A EN 20070205
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DRYSTAR AXYS
The Drystar AXYS carries the CE, TÜV, cULus and CCC labels.
Figure 21: Location CE, TÜV, cULus and CCC label
1. CCC label
2. CE, TÜV and cULus label
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2852 A EN 20070205
DRYSTAR AXYS
Patient Data Security
It is the responsibility of the hospital to ensure that the patients’ legal requirements are met and that the security of the patient records is:
Q maintained and tested,
Q audited,
Q administered locally to cover risks from third party access and
Q how the availability of the services is to be maintained in the event of disaster.
It is the responsibility of the hospital to ensure that types of access are identified, classified and reasons for access are justified.
Node authentication, certificates and Certification
Authority
Each device - connected to a network - will receive a unique identifier: the
X.509 certificate, a digital passport. Any device on the network is only allowed
to communicate with another node of which it is holding the certificate in a
‘communication allowed’ table.
A Certification Authority (CA) is responsible for creating a certificate. The CA
can be the hospital, Agfa or a third party.
This CA distributes the certificate to the hospital security responsible or service
technician, who for his part:
Q Imports the device certificate, created by the CA.
Q Imports the certificates of all peer devices with which communication is authorized, i.e. creates the list of ‘communication allowed’ device certificates.
2852 A EN 20070205
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DRYSTAR AXYS
Maintenance
Print head cleaning must be done when image quality problems occur. For more
information, refer to “Cleaning the print head” on page 123.
Always consult the Agfa Service documentation and the Agfa trained service
personnel for complete maintenance schedules.
40
2852 A EN 20070205
DRYSTAR AXYS
Environmental protection
Waste Disposal and Environmental Regulations
WEEE Notice
The Directive on Waste Electrical and Electronic Equipment (WEEE), which
entered into force as European law on 13th February 2003, resulted in a major
change in the treatment of electrical equipment at end-of-life. The purpose of
this Directive is, as a first priority, the prevention of WEEE, and in addition, to
promote the reuse, recycling and other forms of recovery of such wastes so as to
reduce the disposal of waste.
The WEEE logo on the product or on its box indicates that this product must not
be disposed of or dumped with household waste. The owner of the equipment is
liable to dispose of all electronic or electrical waste equipment by delivering it
to the specified collection point for recycling of such hazardous waste. Collection and proper recovery of electronic and electrical waste equipment at the
time of disposal will allow the producer to help conserve natural resources.
Recycling of the electronic and electrical waste equipment will ensure safety of
human health and the environment. For more information about electronic and
electrical waste equipment disposal, recovery and collection points, please contact your local waste disposal service or producer / distributor of this equipment.
If your equipment contains removable batteries or accumulators please dispose
of these separately according to local regulations.
Figure 22: The WEEE logo EN 50419: 2005
2852 A EN 20070205
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DRYSTAR AXYS
Restriction of the Use of Certain Hazardous
Substances (RoHS)
The RoHS (Restriction of Hazardous Substances)
Directive No 2002/95/EC of the European Union focuses on the restriction of
the use of certain hazardous substances in electrical and electronic equipment.
Member States of the European Union (EU) shall ensure that, from 1 July 2006,
new electrical and electronic equipment put on the market (EU countries), does
not contain the following substances above specified concentrations at the
homogeneous material level:
Q Cadmium (0.01%)
Q Hexavalent chromium (0.1%)
Q Lead (0.1%)
Q Mercury (0.1%)
Q Polybrominated biphenyls (PBB) (0.1%)
Q Polybrominated diphenyl ethers (PBDE) (0.1%)
At the date of preparation of this manual, Medical Devices are exempted of the
RoHS Directive.
However Agfa HealthCare is committed to meet the requirements of the European RoHS Directive in case the exemption is cancelled.
If there is a RoHS label at the rear of the printer it means that the printer is
RoHS compliant and does not contain the above listed substances above the
mentioned concentrations at the homogeneous material level.
In case of questions or more detailed information do not hesitate to contact
your local sales organization.
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2852 A EN 20070205
DRYSTAR AXYS
Safety Directions
Q Observe the following general safety guidelines:
WARNING: Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.
WARNING: Safety is only guaranteed when trained personnel have
installed Drystar AXYS.
WARNING: All Agfa medical products must be used by Agfa trained
and qualified personnel.
WARNING: [The user is responsible for judging image quality and
controlling environmental conditions for diagnostic softcopy or
print viewing.]
WARNING: [Any error (crash/ lock up) leading to an image
processing failure can cause loss of diagnostic information.]
Caution: Position the Agfa product so that it is possible to disconnect the
mains power connection if required.
Caution: Changes, additions or maintenance to the Agfa products carried
out by persons without appropriate qualification and training as well as
using unapproved spare parts may lead to serious risk of injury and
damage to the equipment as well as making the warranty void.
Q When operating or maintaining the Drystar AXYS, always observe the following
safety guidelines:
WARNING: The Drystar AXYS 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.
WARNING: All images created using any image technology can
show artifacts, which could be mixed up with diagnostic relevant
information. If there is any doubt that the diagnostic information
could not be absolutely true, additional investigations must be
performed to get a clear diagnostic.
WARNING: Have electrical or mechanical defects repaired by
qualified personnel only!
WARNING: Always switch off the Drystar AXYS and disconnect the
power cord from the outlet before carrying out any maintenance
work.
2852 A EN 20070205
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DRYSTAR AXYS
WARNING: Do not override or disconnect the integrated safety
features
Caution: Ventilation openings should not be covered.
Q [In the United States, Federal law restricts this device to sale, distribution and
use by, or on order of, a licensed physician.]
WARNING: (U.S.A. only): In accordance with U.S. Law, this device
can only be sold to or ordered by a licensed physician.
WARNING: Printed images should be treated as patient records
and should only be viewed by authorized personnel.
WARNING: It is advisable to do a reprint when film artifacts are
present in the image.
In case of general image quality degradation, please refer to
“Maintaining image quality and resolving image quality problems”
on page 258 (Reference manual).
Caution: (USA only): Make sure that the circuit is single-phase centertapped, if the printer is connected to a 240 V/60 Hz source instead of a
120 V/60 Hz source.
44
2852 A EN 20070205
2
Getting Started
This chapter covers the following topics:
❑
Drystar AXYS Basic Features
❑
Switching on the Drystar AXYS
❑
Drystar AXYS Basic Workflow
❑
Cooling down the Drystar AXYS
❑
Switching off the Drystar AXYS
DRYSTAR AXYS
Drystar AXYS Basic Features
The Drystar AXYS offers the following features:
Q The Drystar AXYS is a Dicom-only network printer
Q Dry technology for printing diagnostic quality hardcopies in full daylight offers
important advantages: no chemistry, no wet processing, simple cleaning procedures, no time-consuming adjustments, no darkroom and no chemical disposal
costs. The consumables can be loaded in full daylight.
Q With its compact design, the Drystar AXYS needs little workspace and allows
easy customer access. Maintenance and service activities are reduced to a minimum.
Q The input trays of the Drystar AXYS are equipped with an RF-tag reader, which
automatically traces the films used in the printer and protects the printer when
detecting non-identified media.
Q Number of input trays: The Drystar AXYS is equipped with 2 input trays. Both
input trays can use multiple formats (8x10” up to 14x17”) of Drystar DT 2 B and
DT 2 C and optionally Drystar DT 2 Mammo (8x10”, 10x12” and 11x14”).
Q Number of output trays: The Drystar AXYS is equipped with 1 output tray,
which is suitable for the multiple formats without any adjustment.
Q A Quality Control software module is available for the key-operator.
The QC procedure for general radiography applications has been designed to
comply with the grayscale reproduction constancy test, according to the international standard IEC 1223-2-4.
The QC procedure for the optional mammography application has been
designed to comply with the NEMAStandards Publication XR 23-2006.
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2852 A EN 20070205
DRYSTAR AXYS
Q Integrated A#sharp technology.
A#sharp is a technology that enhances image sharpness for the Drystar AXYS.
An A#sharp label on the lower tray shows that the imager is equipped with this
technology.
1. A#Sharp label
2852 A EN 20070205
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DRYSTAR AXYS
Switching on the Drystar AXYS
Note: Before switching on the Drystar AXYS, read the safety instructions.
Refer to “Safety Directions” on page 43.
Follow the procedure below to ensure proper start-up of the Drystar AXYS and
to check that everything is working correctly.
Procedure:
Check that the power cord is plugged in and then switch on the printer by pressing the Power/Reset button.
On the display, the following message is displayed. After a short while, a progress indicator will show the progress of the self-test.
If anything goes wrong during the self-test, refer to “Start-up errors” on page 256.
48
The printer is ready for operation:
2852 A EN 20070205
DRYSTAR AXYS
If, on the front panel display, the READY message is shown, the status indicator LED is
constantly green.
Note: It takes 9 minutes before the Drystar AXYS can start printing. After 4
minutes the READY message appears and from then on you can send print
jobs to the printer, but it will take another five minutes for the printer head
to heat up. When you send print jobs to the Drystar AXYS during this five
minutes, the printer will use that time to calculate the print job and the
display will inform you that the printer is warming up.
If, on the front panel display, the print queue screen is shown,
the status indicator LED is green and blinking.
Mod.name
PR
Make sure that the printer is loaded with appropriate consumables.
Note: Refer to page for detailed information on loading films.
Note: If the job status displays a warning or error indication, refer to
“Troubleshooting checklist” on page 127.
2852 A EN 20070205
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DRYSTAR AXYS
Drystar AXYS Basic Workflow
Controlling the Working of the
Drystar AXYS
You can control the working of the Drystar AXYS via the local keypad or via a
networked remote PC.
The Drystar AXYS can be operated in five modes: Operator mode, Key-operator
mode, Service mode, Specialist mode and Administrator mode.
The table below gives an overview of the operating modes you can access
locally and/or via the remote PC.
Local
Password
protected
Remote
Password
protected
Operator mode
No
Operator mode
Yes
Key-operator mode
No
Key-operator mode
Yes
–––
–––
Service mode
Yes
–––
–––
Specialist mode
Yes
–––
–––
Administrator
Yes
The manual describes the controlling of the Drystar AXYS via the local keypad.
The menus for controlling the Drystar AXYS via a remote PC are structured in
the same way and sometimes they offer even more possibilities. Refer to the
chapter “Controlling the Drystar AXYS via a remote PC (with browser)” on
page 219 of the Reference manual.
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2852 A EN 20070205

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