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.
DRYSTAR AXYS 1 Introduction .......................................................................................7 Introduction to this Manual................................................................................ 8 Scope of this Manual ............................................................................................ 8 Warnings, Cautions, Instructions and Notes ......................................................... 9 Disclaimer.....................................................
DRYSTAR AXYS Environmental protection................................................................................... 41 Waste Disposal and Environmental Regulations ............................................. 41 Restriction of the Use of Certain Hazardous Substances (RoHS) ....................42 Safety Directions ................................................................................................43 2 Getting Started .......................................................................
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 .....................................................................
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) .........................................
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.
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.
DRYSTAR AXYS 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.
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.
DRYSTAR AXYS Configuration Main Components The figure below illustrates the main components of the printer 1 3 2 4 Figure 2: Front view 1. Top cover 2. Output tray 3. User interface (refer “Overview of user interface controls” on page 15 4.
DRYSTAR AXYS 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.
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.
DRYSTAR AXYS 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 1 2 6 3 4 5 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.
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.
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.
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.
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.
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.
DRYSTAR AXYS 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.
DRYSTAR AXYS Compliance This paragraph sums up the directives, standards and harmonization initiatives Drystar AXYS complies with.
DRYSTAR AXYS 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.
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.
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).
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”.
DRYSTAR AXYS 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.
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.
DRYSTAR AXYS 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.
DRYSTAR AXYS Connections At the rear side of the printer, one slot and three connectors are available: 1 CF-card slot To insert an external CF-card for software installation, backup, etc. 2 Network connector To connect to the hospital network. 3 Input/output connector To connect a terminal PC (used by the Service engineer). 4 Power connector To connect the printer power cord. The figure below illustrates the back-to-back connections of the printer 1 2 3 4 Figure 7: Rear view 1.
DRYSTAR AXYS 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.
DRYSTAR AXYS Procedure: 1 Switch off the Drystar AXYS (refer to “Switching off the Drystar AXYS” on page 63). 2 Disconnect the cables. 3 Move the Drystar AXYS to its destination (with 2, preferably 3 persons!). 4 Reconnect the cables. 5 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).
DRYSTAR AXYS Proceed as follows to perform the mechanical modification: 1 Make sure that the printer is in ‘Ready’ mode. 2 Open the input tray you want to adapt and remove eventually loaded films. 3 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.
DRYSTAR AXYS 34 4 Remove the film position tab. 5 Put the filmion tab in place and push it down until it locks. Tighten the screws of the width format tabs. 6 Load a new film pack. Refer to “Loading films” on page 76.
DRYSTAR AXYS 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.
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.
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.
DRYSTAR AXYS The Drystar AXYS carries the CE, TÜV, cULus and CCC labels. 1 2 Figure 21: Location CE, TÜV, cULus and CCC label 1. CCC label 2.
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.
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.
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.
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.
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.
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.
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.
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 1.
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: 1 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.
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.
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.
