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

Agfa Gevaert N V Drystar Axys /xxx Medical tabletop printer manual part 1

Contents

manual part 1

Drystar AXYSUser Manual2852 A EN 20070205
22852 A EN 20070205DRYSTAR AXYSNo parts of this document may be reproduced, copied, adapted or transmitted in any form or by any means with-out 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 ofsuitability for any particular purpose. Agfa-Gevaert N.V. shall under no circumstances be liable for any damagearising 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. 2007.0413
32852 A EN 20070205DRYSTAR AXYS1 Introduction .......................................................................................7Introduction to this Manual................................................................................ 8Scope of this Manual............................................................................................ 8Warnings, Cautions, Instructions and Notes ......................................................... 9Disclaimer.......................................................................................................... 10Introduction to Drystar AXYS ........................................................................... 11Intended Use...................................................................................................... 11Intended User .................................................................................................... 11Configuration .................................................................................................... 12Main Components ......................................................................................... 12Functional Description .................................................................................. 13Film Formats ................................................................................................. 14Operation Controls ............................................................................................ 15Overview of user interface controls................................................................ 15The status indicator LED................................................................................ 16The control buttons ....................................................................................... 16System Documentation ...................................................................................... 17Options and Accessories..................................................................................... 18Training ............................................................................................................. 20Product Complaints............................................................................................ 20Compatibility ..................................................................................................... 21Compliance........................................................................................................ 22Directive........................................................................................................ 22Quality Control.............................................................................................. 22Standards...................................................................................................... 23Additional standards for documentation........................................................25Harmonization .............................................................................................. 25Performance ...................................................................................................... 26Connectivity....................................................................................................... 27Network features ........................................................................................... 27Network configuration ..................................................................................28Installation ........................................................................................................ 29Connections .................................................................................................. 30Transport after installation............................................................................ 31Changing the film format of the trays ............................................................ 32Messages............................................................................................................ 35Labels ................................................................................................................ 36Patient Data Security .........................................................................................39Node authentication, certificates and Certification Authority ........................ 39Maintenance ...................................................................................................... 40
42852 A EN 20070205DRYSTAR AXYSEnvironmental protection................................................................................... 41Waste Disposal and Environmental Regulations............................................. 41Restriction of the Use of Certain Hazardous Substances (RoHS) ....................42Safety Directions ................................................................................................432 Getting Started ............................................................................... 45Drystar AXYS Basic Features ............................................................................ 46Switching on the Drystar AXYS ........................................................................ 48Drystar AXYS Basic Workflow .......................................................................... 50Controlling the Working of the Drystar AXYS .....................................................50Operator mode ..............................................................................................51Key-operator mode ........................................................................................51Service mode.................................................................................................51Specialist mode .............................................................................................52Administrator mode (also known as Security)................................................52Working with the keypad....................................................................................53The display.........................................................................................................55General display features ................................................................................56Operator mode ..............................................................................................57Key-operator mode ........................................................................................58Data entry .....................................................................................................58Audio signals......................................................................................................59Working with Compact flash cards (CF-card)......................................................60Cooling down the Drystar AXYS ....................................................................... 62Switching off the Drystar AXYS........................................................................ 633 Basic operation (Operator mode) ...................................................................................... 65Overview of operator functions........................................................................ 66Managing the print queue .................................................................................67Checking the print queue ...................................................................................67The local print queue screen...............................................................................68Pausing the print queue ................................................................................... 69Viewing the film count info .............................................................................. 70Viewing the printer status ................................................................................ 71Deleting print jobs............................................................................................ 72About Drystar AXYS consumables .................................................................... 73
52852 A EN 20070205DRYSTAR AXYSLabeling the input trays...................................................................................... 74Loading films.................................................................................................... 76When the Drystar AXYS is printing or calculating and an input tray is empty ...... 77When the Drystar AXYS is in the ready state and an input tray is empty.............. 78Film loading procedure ...................................................................................... 79Checking the correct position of a film in the input tray...................................... 834 Advanced operation(Key-operator mode) ...............................................................................85Overview of key-operator functions ................................................................. 86Quality Control for general radiography applications (DT 2 B & DT 2 C) ......... 87Establishing the reference values and verifying image quality for general radiogra-phy applications (DT 2 B and DT 2 C)................................................................. 88QC test image for general radiography applications (DT 2 B and DT 2 C) ....... 90Establishing the daily operating reference density levels for general radiographyapplications (DT 2 B and DT 2 C)................................................................... 91Establishing the image geometry reference values for general radiographyapplications (DT 2 B and DT 2 C)................................................................... 95Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visi-bility for general radiography applications (DT 2 B and DT 2 C)..................... 96Performing quality control (QC) tests for general radiography applications (DT 2 Band DT 2 C)........................................................................................................98Performing the daily QC test for general radiography applications (DT 2 B andDT 2 C).......................................................................................................... 99Performing the Weekly QC tests for general radiography applications (DT 2 Band DT 2 C)................................................................................................. 101Performing the Annual QC tests for general radiography applications (DT 2 Band DT 2 C)................................................................................................. 103Quality control for mammography application (DT 2 Mammo) (optional).... 104Establishing the reference values and verifying image quality for mammographyapplication (DT 2 Mammo) (optional) ............................................................. 105QC test image for mammography applications (DT 2 Mammo) (optional) ... 107Establishing the daily operating reference density levels for mammographyapplication (DT 2 Mammo) (optional)......................................................... 108Establishing the image geometry reference values for mammography applica-tion (DT 2 Mammo) (optional).................................................................... 112Verifying Acceptable Spatial Resolution and Artifact Levels and Low ContrastVisibility for mammography application (DT 2 Mammo) (optional)............. 113Performing quality control (QC) tests for mammography application(DT 2 Mammo) (optional) ............................................................................... 115
62852 A EN 20070205DRYSTAR AXYSPerforming the daily QC test for mammography application (DT 2 Mammo)(optional).................................................................................................... 116Performing the Weekly QC tests for mammography application (DT 2 Mammo)(optional).................................................................................................... 118Performing the Annual QC tests for mammography application (DT 2 Mammo)(optional)....................................................................................................120Preventive maintenance schedule ...................................................................121Safety guidelines.............................................................................................. 121Cleaning the exterior...................................................................................... 122Cleaning the print head.................................................................................. 123Troubleshooting checklist ...............................................................................127Clearing of film jams ...................................................................................... 129Film input tray jams..........................................................................................130Film transport jams (clearing from the top)......................................................133Unauthorized opening of the printer ................................................................136Film identification problems ...........................................................................137No identification code detected ........................................................................138Invalid content of Film Identification tag ......................................................... 141Film overrun from current pack........................................................................ 141A Equipment information sheet ....................................................143Specifications ..................................................................................................144Viewing the system info area on a film............................................................148B Quality Control Charts ................................................................149Charts for general radiography QC ................................................................ 150Charts for mammography QC (optional) ....................................................... 155
1 IntroductionThis chapter covers the following topics:❑Introduction to this Manual❑Introduction to Drystar AXYS
82852 A EN 20070205DRYSTAR AXYSIntroduction to this ManualScope of this ManualThis manual contains information for the safe and effective operation of AGFAHealthcare products.This manual contains all instructions for the key-operator or any other skilledperson, to work easily and correctly with the Drystar AXYS.
92852 A EN 20070205DRYSTAR AXYSWarnings, Cautions, Instructions and NotesThe following samples show how warnings, cautions, instructions and notesappear in this document. The text explains their intended use.Figure 1: Safety iconsThe purpose of the safety icons shown above is to indicate at a glance the type ofwarning or danger.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.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 warningNote: Notes provide advice and highlight unusual points. A note is not intended as an instruction.
10 2852 A EN 20070205DRYSTAR AXYSDisclaimerAgfa assumes no liability for use of this document if any unauthorized changesto the content or format have been made.Every care has been taken to ensure the accuracy of the information in this doc-ument. However, Agfa assumes no responsibility or liability for errors, inaccura-cies, or omissions that may appear in this document.Agfa reserves the right to change the product without further notice to improvereliability, function or design. This manual is provided without warranty of anykind, implied or expressed, including, but not limited to, the implied warrantiesof merchantability and fitness for a particular purpose.
112852 A EN 20070205DRYSTAR AXYSIntroduction to Drystar AXYSIntended UseThe Drystar AXYS is a dry digital tabletop printer for producing medical diag-nostic images. It can print multiple formats (8x10”, 10x12”, 11x14”, 14x14” and14x17”) of blue-based (Drystar DT 2 B) and clear-based (Drystar DT 2 C) filmand offers crisp, dense grayscale images. The Drystar AXYS can be used for gen-eral radiography and optionally for the mammography application. It isdesigned for high-throughput and for use as a central printer.Intended UserThis manual is written for trained users of Agfa products. Users are consideredas the persons who actually handle the equipment as well as the persons havingauthority over the equipment. Before attempting to work with this equipment,the user must read, understand, note and strictly observe all warnings, cautionsand safety markings on the equipment.
12 2852 A EN 20070205DRYSTAR AXYSConfigurationMain ComponentsThe figure below illustrates the main components of the printerFigure 2: Front view1. Top cover2. Output tray3. User interface (refer “Overview of user interface controls” on page 154. Input tray1 324
132852 A EN 20070205DRYSTAR AXYSFunctional DescriptionThe Drystar AXYS consists of two functional blocks: a controller and a printengine.QThe controllerThe controller captures the incoming data and stores the image.The controller composes the different images and generates the appropriateprint engine control signals.QThe print engineThe print engine receives the image data from the controller, drives the filmthrough the device and produces black & white hardcopy prints.The figure below illustrates how the film is transported through the printerFigure 3: Film transport1. Film pick up unit2. Output module3. Print head module4. Drum5. Film path 14352
14 2852 A EN 20070205DRYSTAR AXYSFilm FormatsMultiple film formats (8x10”, 10x12”, 11x14”, 14x14” and 14x17”) can be used.Any combination of two film formats can be used “online”. Both input trays canbe adjusted for all film formats.
152852 A EN 20070205DRYSTAR AXYSOperation ControlsThe Drystar AXYS interfaces with the user via the following controls:QPower/Reset button;Qa keypad and a display;Qa status indicator;Qaudio signals.Overview of user interface controlsFigure 4: User interface controls1. Power/Reset button2. Display3. Keypad4. Status indicator LED5. Film input trays6. Film output trayWARNING: Never try to open the printer when the Drystar AXYS is printing a film. Always follow the instructions on the display!1 23465
16 2852 A EN 20070205DRYSTAR AXYSThe status indicator LEDOn the right side of the display, an LED indicates the status of the Drystar AXYS.The control buttonsOne control button has been provided:Colour/Light Status ActionGreen Constant Ready (stand-by) ProceedBlinking Busy or in key-opertormodeWaitRed Constant Warning status Check the display formessages. Refer to “Checking thestatus indicator LED”on page 241 of the Ref-erence manual.Blinking Error statusTable 1: Status indicator LEDPower/Reset button •To power on or off the printer.•To reset the printer.Table 2: Control buttonsWARNING: 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
172852 A EN 20070205DRYSTAR AXYSSystem DocumentationThe documentation shall be kept with the system for easy reference. Technicaldocumentation is available in the product service documentation that is avail-able from your local support organisation.The documentation consists of:QReference Manual (English only), this document.QUser Manual, document 2852.QPlug & Play Manual, document 2851 & 2855.QMobile installation Kit, document 2854.QPacking slip, document 2850.QDocumentation CD
18 2852 A EN 20070205DRYSTAR AXYSOptions and AccessoriesQABC Ordering CodesThe table below lists the ordering codes for the Drystar AXYS and possibleoptions.Description ABC code RemarkDrystar AXYS EYZ4E A#sharp technology is includedMammo option forDrystar AXYSEY8RN A#sharp technology is includedThe Drystar AXYS can be used forprinting mammography applicationfilms. For this option, a license has tobe activated by an Agfa service techni-cian. The feature comes with a QC pro-cedure that complies with the NEMAStandards Publication XR 23-2006.For more information, refer to “Qual-ity control for mammography applica-tion (DT 2 Mammo) (optional)” onpage 104.Contact your local service organiza-tion for more information.Cleaning roller tissue EQU6YMobile / EarthquakeprovisionEX2DV The installation kit allows you to usethe Drystar AXYS in a van, or to use itin unstable environment. It containsthe necessary equipment to fix theprinter onto a table, and has provisionsfor easy service access. The mobile/earthquake installation kit is deliveredwith the necessary mounting instruc-tions.No additional software for mobile/earthquake use is required.Table 3: ABC ordering codes
192852 A EN 20070205DRYSTAR AXYSQAvailable Software codesThe table below lists the available software versions and the type of printer theyrequire.QConsumablesThe Drystar AXYS can handle DRYSTAR DT 2 B and DRYSTAR DT 2 C consum-ables (both are general radiography film types) in multiple formats (8x10” upto 14x17”) and optionally DRYSTAR DT 2 Mammo (mammograpy film type)consumables, available in the formats 8x10”, 10x12” and 11x14”.Software version (SW) Printer1.60 Drystar AXYS RoHS compatibleTable 4: Software version
20 2852 A EN 20070205DRYSTAR AXYSTrainingThe user must have received adequate Agfa training on the safe and effectiveuse of the product before attempting to work with it. Training requirementsmay vary from country to country. The user must make sure that training isreceived 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 thismanual:QIntended UseQIntended UserQSafety DirectionsProduct ComplaintsAny health care professional (for example a customer or a user) who has anycomplaints or has experienced any dissatisfaction in the quality, durability, reli-ability, safety, effectiveness, or performance of this product must notify Agfa.If the device malfunctions and may have caused or contributed to a seriousinjury of a patient, Agfa must be notified immediately by telephone, fax or writ-ten correspondence to the following address:Agfa Service Support - local support addresses and phone numbers are listed onwww.agfa.comAgfa - Septestraat 27, 2640 Mortsel, BelgiumAgfa- Fax +32 3 444 7094
212852 A EN 20070205DRYSTAR AXYSCompatibilityDrystar AXYS must only be used in combination with other equipment or com-ponents if these are expressly recognized by Agfa as compatible. A list of suchequipment and components is available from Agfa service on request.Changes or additions to the equipment must only be carried out by personsauthorized to do so by Agfa. Such changes must comply with best engineeringpractice and all applicable laws and regulations that have the force of lawwithin the jurisdiction of the hospital.Drystar AXYS is a Dicom printer and can therefore be connected to Agfa equip-ment and all modalities supporting Dicom. Although, to ensure optimal opera-tion and image quality, Agfa has made the effort to test and release theDrystar AXYS with most of modalities on the market. For the complete list or ifyou want to check on a specific modality, contact your Agfa representative.
22 2852 A EN 20070205DRYSTAR AXYSComplianceThis paragraph sums up the directives, standards and harmonization initiativesDrystar AXYS complies with.DirectiveCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJNo L 169/1 of 1993-07-12)QANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTSThe 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.QANNEX II - EC DECLARATION OF CONFORMITY Full quality assurance system ISO 13485QANNEX X - CLINICAL EVALUATION The clinical evaluation follows a defined and methodologically sound proce-dure.Quality ControlQThe 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.QThe 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
232852 A EN 20070205DRYSTAR AXYSStandardsQISO 14971:2000, Medical devices - Application of risk management to medical devicesQIEC 60601-1-2 It specifies the manufacturer of the medical equipment or medi-cal 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 elec-tromagnetic environment of use to permit the medical equipment or medical system to maintain basic safety and provide its essential performance without disturbing other equipment.QSeismic (earthquake) requirementsThe printer meets the CA (Californian) requirements.Safety standardsQIEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceQIEC 60601-1 + A1 + A2QEN 60601-1 + A1 + A2QUL 60601-1QCSA 22.2 No. 601.1-M90QGB4943-2001 (for CCC-Mark)EMCQFCC Rules 47 CFR part 15 subpart BQIEC 60601-1-2QCISPR 11, class AQCISPR 22, class AQIEC 61000-4-3
24 2852 A EN 20070205DRYSTAR AXYSQIEC 61000-4-4QIEC 61000-4-5QIEC 61000-4-6QIEC 61000-3-2QIEC 61000-3-3QIEC 61000-4-11QETSI 300330QGB9254-1998(Class A) (for CCC-Mark)QGB17625.1-2003 (for CCC-Mark)QUSA: 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 gener-ates, 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 resi-dential 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.QCanada: This class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.QEC: 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 mea-sures.
252852 A EN 20070205DRYSTAR AXYSAdditional standards for documentationIEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presen-tationHarmonizationQGlobal Harmonization Task Force (GHTF) www.ghtf.orgThis document been has prepared to comply with Study Group 1 guidance doc-ument of the Global Harmonization Task Force (GHTF). To assist developmentof a consistent, harmonized definition for a medical device that could be usedwithin a global regulatory model would offer significant benefits to the manu-facturer, user, patient or consumer, and to Regulatory Authorities and supportglobal convergence of regulatory systems.QIECEE CB SCHEME www.iecee.orgThe IECEE CB Scheme is the world's first truly international system for accep-tance of test reports dealing with the safety of electrical and electronic prod-ucts. It is a multilateral agreement among participating countries andcertification organizations. Agfa has produced a CB test report and claimsnational certification in all other member countries of the CB Scheme.
26 2852 A EN 20070205DRYSTAR AXYSPerformanceQThe 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 den-sity of 3.8 for optional mammography application (measured with an X-Rite densitometer).QMultiple 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.
272852 A EN 20070205DRYSTAR AXYSConnectivityThe Drystar AXYS is a standard network printer. This means that you can justplug it into the (existing) ethernet network without any additional options oraccessories. Drystar AXYS is also a native DICOM printer. Therefore the stan-dard DICOM protocol can be used as network protocol, and again without anyadditional options or accessories the printer will be able to process and print theDICOM jobs.Network featuresQThe modular design offers optimal application functionality for your specific networking requirements.In a network configuration, the Drystar AXYS is fully compatible with all otherAGFA imaging system components, including the CR digitizers, CR worksta-tions, image buffer components, Paxport and the entire line of Impax stations.For more information, contact your Agfa representativeQThe modular design offers optimal application functionality for your specific networking requirements.QThe functionality of the Drystar AXYS is completely controlled via the network.QYou can control the working of the Drystar AXYS via the local keypad or via a remote PC with a functioning web browser.
28 2852 A EN 20070205DRYSTAR AXYSNetwork configurationFigure 5: Figure 6: Network configuration* A Paxport is required if the modality is not a DICOM modality.PaxportModalityDrystar AXYSPACSCR WorkstationNetworkImagesExample of Drystar AXYS in a network configuration*PaxportExample of Drystar AXYS in a point-to-point configurationModality Drystar AXYS*
292852 A EN 20070205DRYSTAR AXYSInstallationDrystar AXYS installation and configuration is performed by Agfa. (A limitednumber of configuration tasks can also be performed by the customer after anAgfa training course has been provided.) Contact your local support organiza-tion 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 man-ual.
30 2852 A EN 20070205DRYSTAR AXYSConnectionsAt the rear side of the printer, one slot and three connectors are available:The figure below illustrates the back-to-back connections of the printerFigure 7: Rear view1. CF-card slot2. Network3. RS-232 =>Service PC4. Power connection1 CF-card slot To insert an external CF-cardfor software installation, back-up, etc.2 Network connector To connect to the hospital net-work.3 Input/output connector To connect a terminal PC (usedby the Service engineer).4 Power connector To connect the printer powercord.4321
312852 A EN 20070205DRYSTAR AXYSTransport after installationThe 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:Figure 8: Transport posibilitiesNote: 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.
32 2852 A EN 20070205DRYSTAR AXYSProcedure:1Switch off the Drystar AXYS (refer to “Switching off the Drystar AXYS” on page 63).2Disconnect the cables.3Move the Drystar AXYS to its destination (with 2, preferably 3 persons!).4Reconnect the cables.5Switch Drystar AXYS on (refer to “Switching on the Drystar AXYS” on page 48).Changing the film format of the traysThe key-operator can adjust the film size setting of both input trays (8x10” up to14x17” film sizes).Before a different film format can be loaded, the film format settings of the trayhas to be changed. After this modification, the ‘film format’ parameter is auto-matically read from the Film Identification tag when the new film pack isloaded.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.
332852 A EN 20070205DRYSTAR AXYSProceed as follows to perform the mechanical modification:1Make sure that the printer is in ‘Ready’ mode.2Open the input tray you want to adapt and remove eventually loaded films.3Locate the correct tab position for the desired film format.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.8"11"12"14"17"10"14"10” and 14” width tab
34 2852 A EN 20070205DRYSTAR AXYS4Remove the film position tab.5Put the filmion tab in place and push it down until it locks. Tighten the screws of the width format tabs.6Load a new film pack. Refer to “Loading films” on page 76.
352852 A EN 20070205DRYSTAR AXYSMessagesUnder certain conditions the red LED on the right side of the display lits up anda warning or error message is shown on the display. This message informs theuser that either a problem has occurred or that a requested action cannot beperformed.The user must read these messages carefully. It will provide information onwhat to do from then on. This will be either performing an action to resolve theproblem or to contact the Agfa service organization. Details on the contents ofmessages can be found in the service documentation which is available to Agfaservice personnel.Colour/Light Status ActionRed Constant Warning status Check the display formessages. Refer to“Checking the statusindicator LED” onpage 241 of the Refer-ence manual.Blinking Error statusTable 5: Red status indicator LED
36 2852 A EN 20070205DRYSTAR AXYSLabels[The following samples illustrate some of the warning labels (ISO 3864 SafetySigns define the design principles for international safety signs) that mayappear on the medical equipment.]Symbol ExplanationFigure 9: Radiation WarningRadiation Warning Indicates the possibility of increased levels of radi-ation.Figure 10: High Voltage WarningHigh Voltage WarningIndicates the presence of high voltage.Figure 11: Laser WarningLaser WarningIndicates the presence of a laser device.Figure 12: Hot Surface WarningHot Surface WarningIndicates that touching the part indicated cancause burns.Figure 13: Do not sit WarningDo not sit WarningIndicates that sitting on a component can causedamage to the equipment.
372852 A EN 20070205DRYSTAR AXYSAlways take into account the markings provided on the inside and outside ofthe printer. A brief overview of these markings and their meaning is givenbelow.Symbol ExplanationFigure 14: Caution hot:Keep hands clear from the thermal print head.Figure 15: High voltageIn order to reduce the risk of electric shock, do notremove any covers.Figure 16: Type B equipment:Indicates that the Drystar AXYS complies with the lim-its for type B equipment. Figure 17: Supplementary protective earth connector: Provides a connection between the Drystar AXYS andthe potential equalization bus bar of the electrical sys-tem as found in medical environments. This plugshould never be unplugged before the power is turnedoff and the power plug has been removed.Figure 18: Intergrounding connector:Provides a connection between the printer and otherequipment, which might exhibit minor ground poten-tial differences. These differences may degrade thequality of communication between different equip-ment. Never remove connections to this terminal.Figure 19: Protective earth (ground):Provides a connection between the printer and theprotective earth of the mains. Do not remove this con-nection, because this will have a negative influence onthe leakage current.Figure 20: Power buttonNote that the power cord has to be disconnected fromthe wall outlet in order to disconnect the unit entirelyfrom the mains.
38 2852 A EN 20070205DRYSTAR AXYSThe Drystar AXYS carries the CE, TÜV, cULus and CCC labels.Figure 21: Location CE, TÜV, cULus and CCC label1. CCC label2. CE, TÜV and cULus label12
392852 A EN 20070205DRYSTAR AXYSPatient Data SecurityIt is the responsibility of the hospital to ensure that the patients’ legal require-ments are met and that the security of the patient records is:Qmaintained and tested,Qaudited,Qadministered locally to cover risks from third party access andQhow 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 identi-fied, classified and reasons for access are justified.Node authentication, certificates and Certification AuthorityEach device - connected to a network - will receive a unique identifier: theX.509 certificate, a digital passport. Any device on the network is only allowedto 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 CAcan be the hospital, Agfa or a third party.This CA distributes the certificate to the hospital security responsible or servicetechnician, who for his part:QImports the device certificate, created by the CA.QImports the certificates of all peer devices with which communication is autho-rized, i.e. creates the list of ‘communication allowed’ device certificates.
40 2852 A EN 20070205DRYSTAR AXYSMaintenancePrint head cleaning must be done when image quality problems occur. For moreinformation, refer to “Cleaning the print head” on page 123.Always consult the Agfa Service documentation and the Agfa trained servicepersonnel for complete maintenance schedules.
412852 A EN 20070205DRYSTAR AXYSEnvironmental protectionWaste Disposal and Environmental RegulationsWEEE NoticeThe Directive on Waste Electrical and Electronic Equipment (WEEE), whichentered into force as European law on 13th February 2003, resulted in a majorchange in the treatment of electrical equipment at end-of-life. The purpose ofthis Directive is, as a first priority, the prevention of WEEE, and in addition, topromote the reuse, recycling and other forms of recovery of such wastes so as toreduce the disposal of waste.The WEEE logo on the product or on its box indicates that this product must notbe disposed of or dumped with household waste. The owner of the equipment isliable to dispose of all electronic or electrical waste equipment by delivering itto the specified collection point for recycling of such hazardous waste. Collec-tion and proper recovery of electronic and electrical waste equipment at thetime of disposal will allow the producer to help conserve natural resources.Recycling of the electronic and electrical waste equipment will ensure safety ofhuman health and the environment. For more information about electronic andelectrical waste equipment disposal, recovery and collection points, please con-tact your local waste disposal service or producer / distributor of this equip-ment.If your equipment contains removable batteries or accumulators please disposeof these separately according to local regulations.Figure 22: The WEEE logo EN 50419: 2005
42 2852 A EN 20070205DRYSTAR AXYSRestriction 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 ofthe 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), doesnot contain the following substances above specified concentrations at thehomogeneous material level:QCadmium (0.01%) QHexavalent chromium (0.1%) QLead (0.1%) QMercury (0.1%) QPolybrominated biphenyls (PBB) (0.1%) QPolybrominated diphenyl ethers (PBDE) (0.1%) At the date of preparation of this manual, Medical Devices are exempted of theRoHS Directive.However Agfa HealthCare is committed to meet the requirements of the Euro-pean 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 isRoHS compliant and does not contain the above listed substances above thementioned concentrations at the homogeneous material level.In case of questions or more detailed information do not hesitate to contactyour local sales organization.
432852 A EN 20070205DRYSTAR AXYSSafety DirectionsQObserve the following general safety guidelines:QWhen operating or maintaining the Drystar AXYS, always observe the following 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.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.
44 2852 A EN 20070205DRYSTAR AXYSQ[In the United States, Federal law restricts this device to sale, distribution and use by, or on order of, a licensed physician.]WARNING: Do not override or disconnect the integrated safety featuresCaution: Ventilation openings should not be covered.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 center-tapped, if the printer is connected to a 240 V/60 Hz source instead of a 120 V/60 Hz source.
2 Getting StartedThis 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
46 2852 A EN 20070205DRYSTAR AXYSDrystar AXYS Basic FeaturesThe Drystar AXYS offers the following features:QThe Drystar AXYS is a Dicom-only network printerQDry technology for printing diagnostic quality hardcopies in full daylight offers important advantages: no chemistry, no wet processing, simple cleaning proce-dures, no time-consuming adjustments, no darkroom and no chemical disposal costs. The consumables can be loaded in full daylight.QWith its compact design, the Drystar AXYS needs little workspace and allows easy customer access. Maintenance and service activities are reduced to a mini-mum.QThe 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.QNumber 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”).QNumber of output trays: The Drystar AXYS is equipped with 1 output tray, which is suitable for the multiple formats without any adjustment.QA 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 inter-national 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.
472852 A EN 20070205DRYSTAR AXYSQIntegrated 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 thistechnology.1. A#Sharp label1
48 2852 A EN 20070205DRYSTAR AXYSSwitching on the Drystar AXYSFollow the procedure below to ensure proper start-up of the Drystar AXYS andto check that everything is working correctly.Procedure:1Check that the power cord is plugged in and then switch on the printer by press-ing the Power/Reset button.On the display, the following message is displayed. After a short while, a progress indi-cator will show the progress of the self-test.If anything goes wrong during the self-test, refer to “Start-up errors” on page 256.2The printer is ready for operation:Note: Before switching on the Drystar AXYS, read the safety instructions. Refer to “Safety Directions” on page 43.
492852 A EN 20070205DRYSTAR AXYSIf, on the front panel display, the READY message is shown, the status indicator LED isconstantly green.If, on the front panel display, the print queue screen is shown, the status indicator LED is green and blinking.3Make sure that the printer is loaded with appropriate consumables.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.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.Mod.name PR1 2
50 2852 A EN 20070205DRYSTAR AXYSDrystar AXYS Basic WorkflowControlling the Working of the Drystar AXYSYou can control the working of the Drystar AXYS via the local keypad or via anetworked remote PC.The Drystar AXYS can be operated in five modes: Operator mode, Key-operatormode, Service mode, Specialist mode and Administrator mode. The table below gives an overview of the operating modes you can accesslocally and/or via the remote PC.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 inthe same way and sometimes they offer even more possibilities. Refer to thechapter “Controlling the Drystar AXYS via a remote PC (with browser)” onpage 219 of the Reference manual.Local Password protected Remote Password protectedOperator mode No Operator mode YesKey-operator mode No Key-operator mode Yes––– ––– Service mode Yes––– ––– Specialist mode Yes––– ––– Administrator Yes

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