| Drystar AXYS | Contents Contents Legal Notice ................5 About the safety notices in this document ......6 Drystar AXYS .................7 Scope .................8 Intended use ..............9 Available Software versions ........10 Film types ..............11 Labeling the input trays ........11...
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Drystar AXYS | Contents | iii Key-operator mode ........52 Service mode ..........53 Specialist mode ..........54 Administrator mode ........55 The local user interface ..........56 Messages ............. 58 The status indicator LED ......59 The control buttons ........60 Rear panel ............61...
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| Drystar AXYS | Contents QC test image for mammography application Establishing the daily operating reference density levels for mammography application ..111 Establishing the image geometry reference values for mammography application ....114 Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visibility for mammography application ......
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. Drystar is a trademark of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement.
6 | Drystar AXYS | About the safety notices in this document About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. DANGER:...
8 | Drystar AXYS | Drystar AXYS Scope The user manual contains general safety instructions, system information and instructions for performing a basic workflow. Refer to the reference manual of the printer for information for the advanced operation of the printer.
Drystar AXYS | Drystar AXYS | 9 Intended use The Drystar AXYS is a dry digital tabletop printer for producing medical diagnostic images. It can print multiple formats of blue-based (8x10 inch, 10x12 inch, 11x14 inch, 14x14 inch and 14x17 inch), clear-based (8x10 inch, 10x12 inch, 11x14 inch, 14x14 inch and 14x17 inch) or Mammo film (8x10 inch, 10x12 inch, 11x14 inch) and offers crisp, dense grayscale images.
(SW) 1.60 Drystar AXYS (RoHS compatible) supports both Drystar 5302 & Drystar AXYS 2.1 and 2.2 support new PCBs on Drystar 5302 & Drystar Axys maintenance software version supporting first Private label printer maintenance software version 3.1.1 patch solving Dicom attribute issue support of additional printer models •...
Drystar AXYS | Drystar AXYS | 11 Film types Film type Film base Application Film sizes Average op- tical densi- (X-Rite 310 densitome- ter) blue-trans- General Ra- 8x10”, Original Agfa bran- parent diography 10x12”, ded Drystar film 11x14”, clear- 14x14”, and transpar- 14x17”...
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12 | Drystar AXYS | Drystar AXYS Appropriate labels have been applied on the input tray(s) by the service personnel at installation of the printer, indicating the type of new film to be loaded when the tray is empty. 2852E EN 20210601 1655...
Drystar AXYS | Drystar AXYS | 13 Specifications Product description Type of product Printer Commercial name Drystar AXYS Original seller/manufacturer Agfa NV Labelling CE-marking Dimensions Dimensions (approx. values in cm) • Unpacked: width 72.8, length 71.5, height 67.6 • Packed: width 89, length 100,...
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14 | Drystar AXYS | Drystar AXYS TIFF Postscript Not available Power consumption - heat dissipation During operation 250 W - 900 kJ/h In stand-by 70 W - 252 kJ/h Peak power (absolute max. rating) 530 W - 1908 kJ/h...
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Drystar AXYS | Drystar AXYS | 15 Noise emission (method of measurement in accordance with DIN 45635 part 19) During operation Max. 64 dBA In stand-by Max. 54 dBA Total acoustic A-weighted noise power During operation 62 dB ( = 6.4Bel = 6.4B) In stand-by 53 dB ( = 5.3Bel = 5.3B)
Manufacturer 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...
18 | Drystar AXYS | 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.
20 | Drystar AXYS | Introduction Intended user This manual is written for trained users. 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.
Drystar AXYS | Introduction | 21 Features Note: The printer is a DICOM-only network printer. The printer offers the following features: • Dry technology for printing diagnostic quality hard copies 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.
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22 | Drystar AXYS | Introduction A#Sharp label Topics: • Network features • Options and accessories 2852E EN 20210601 1655...
Drystar AXYS | Introduction | 23 Network features • The modular design offers optimal application to your specific networking requirements. • The functionality is completely controlled via the network. • You can control the printer via the local keypad or via a remote PC featuring a browser functionality.
24 | Drystar AXYS | Introduction Equipment Classification This device is classified as following: Table 1: Equipment classification Class I equipment Equipment in which protection against electric shock does not relay on basic insulation only, but includes a power supply cord with protective earth conductor.
Drystar AXYS | Introduction | 25 Safety precautions WARNING: Safety is only guaranteed when trained personnel have installed the printer. WARNING: All medical products must be used by trained and qualified personnel. WARNING: The printer must only be operated according to its specifications and its intended use.
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26 | Drystar AXYS | Introduction WARNING: When operating or maintaining the printer, always observe the following safety guidelines: • Have electrical or mechanical defects repaired by skilled personnel only! • Do not modify this equipment without authorization of the manufacturer.
Drystar AXYS | Introduction | 27 Labels 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. Safety warning, indicating that the user manuals of the printer should be consulted before making any connections to other equipment.
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28 | Drystar AXYS | Introduction Date of manufacture Manufacturer Medical device Serial number Unique device identifier, in text format and in machine readable format The most recent version of this document is available on http:// www.agfahealthcare.com/global/en/library/index.jsp WEEE Symbol, see section about Environmental protection.
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Drystar AXYS | Introduction | 29 Laser Warning Indicates the presence of a laser device. Do not sit Warning Indicates that sitting on a component can cause damage to the equipment. 2852E EN 20210601 1655...
30 | Drystar AXYS | Introduction Transport after installation WARNING: Before moving the printer, always switch off the machine. WARNING: The printer must only be transported with all covers closed. WARNING: Do not lift the printer by the output tray.
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Drystar AXYS | Introduction | 31 If only 2 persons are available, li Lift printer from pallet with 3 persons. shown below. If only 2 persons are available, lift as shown below. Put printer on a table. Always put tray side at front.
32 | Drystar AXYS | Introduction Environmental protection Figure 3: WEEE symbol Figure 4: Battery symbol WEEE end user notice The directive on Waste Electrical and Electronic Equipment (WEEE) aims to prevent the generation of electric and electronic waste and to promote the reuse, recycling and other forms of recovery.
Drystar AXYS | Introduction | 33 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.
34 | Drystar AXYS | Introduction For U.S.A. WARNING: In accordance with U.S. Law, this device can only be sold to or ordered by a licensed physician. WARNING: 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.
Drystar AXYS | Introduction | 35 Security precautions WARNING: Printed images should be treated as patient records and should only be viewed by authorized personnel. WARNING: It is good practice not to delete images from the modality, until they are correctly printed.
36 | Drystar AXYS | Introduction Installation The printer installation and configuration is performed by the local support organization. A limited number of configuration tasks can also be performed by the customer after a training course has been provided. Contact your local support organization for more information.
Drystar AXYS | Introduction | 37 Training The user must have received adequate training on the safe and effective use of the system 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.
Drystar AXYS | Introduction | 39 General • The product has been designed in accordance with Regulation (EU) 2017/745 on medical devices (MDR). • ISO 14971:2012 • IEC 60601-1-2 (ed. 4) • The Quality Control test procedure for general radiography applications complies with the grayscale reproduction constancy test, according to the international standard IEC 1223-2-4.
40 | Drystar AXYS | Introduction which case the user will be required to correct the interference at its own expense. If required, contact your local service organization. • Canada: This class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.
Drystar AXYS | Introduction | 41 Connectivity The printer must only be used in combination with other equipment or components if these are expressly recognized by the manufacturer as compatible. A list of such equipment and components is available from your local service representative on request.
42 | Drystar AXYS | Introduction Labels Type label NMPA label Topics: • Viewing the System info area on a film Viewing the System info area on a film General radiography applications On the top right corner of each film, a “System info” area will be printed.
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Drystar AXYS | Introduction | 43 • The controller (image source, date, time, etc.). For more detailed information, refer to the Service documentation. 2852E EN 20210601 1655...
44 | Drystar AXYS | Introduction Patient data security The user must ensure that the patients’ legal requirements are met and that the security of the patient data is guarded. The user must define who can access patient data in which situations.
Drystar AXYS | Introduction | 45 Storage media The user must ensure that patient confidential information is unretrievable from any internal storage media (hard disk drive, SSD or other), before the printer (or the internal storage device) is removed from the premises.
46 | Drystar AXYS | Introduction 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’...
(ISP), set in compliance with point 17(4) and 18(8) of Annex I of the EU Medical Device Regulation 2017/745, must be implemented and used in connection with the use of the Agfa medical device by the Customer (User). These are minimum requirements and designed to protect against unauthorised access that could hamper the device from functioning as intended.
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48 | Drystar AXYS | Introduction • An incident response plan detailing responsibilities and how to react and recover from incidents, shall be in place. Staff involved in the incident response plan shall be trained to respond appropriately and effectively.
Drystar AXYS | Introduction | 49 Operating modes The printer can be operated in five modes: operator mode, Keyoperator mode, service mode, specialist mode, and administrator mode. Topics: • Control modes (local and remote) • Operator mode • Key-operator mode •...
50 | Drystar AXYS | Introduction Control modes (local and remote) You can control the working of the printer via the local keypad or via a networked remote PC. The table below gives an overview of the operating modes you can access locally and/or via the remote PC.
Drystar AXYS | Introduction | 51 Operator mode The operator mode groups all basic functions which are aimed at radiographers without special technical skills: • Producing diagnostic usable hardcopies; • Loading consumables; • Ensuring normal operation of the printer. All functions of the operator mode are described in the User manual.
52 | Drystar AXYS | Introduction Key-operator mode The Key-operator mode groups advanced functions which are aimed at technically skilled operators such as X-ray operators, network managers and service and hospital technicians. The Key-operator mode is menu-driven. The Key-operator functions are described in the Reference manual only.
Drystar AXYS | Introduction | 53 Service mode The service mode functions are reserved for trained service personnel. The service mode is password protected. Acces is possible via a connected remote PC. 2852E EN 20210601 1655...
54 | Drystar AXYS | Introduction Specialist mode The specialist mode functions are reserved for trained service personnel of the Customer Support Center. The specialist mode is password protected and is only accessible by browser via a remote PC. 2852E EN 20210601 1655...
Drystar AXYS | Introduction | 55 Administrator mode The Administrator mode functions are reserved for the System Administrator. The Administrator mode is password protected and is only accessible by browser via a remote PC. 2852E EN 20210601 1655...
56 | Drystar AXYS | Introduction The local user interface The printer interfaces with the user via the following controls: • Power/Reset button; • a keypad and a display; • a status indicator LED; • audio signals. Power/Reset button Display...
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Drystar AXYS | Introduction | 57 • The display 2852E EN 20210601 1655...
58 | Drystar AXYS | Introduction 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.
Drystar AXYS | Introduction | 59 The status indicator LED At the right side of the display, a LED indicates the status of the printer: Color / Light Status Action Green Constant Ready (stand-by) Proceed. Blinking Busy or in Keyoperator Wait.
60 | Drystar AXYS | Introduction The control buttons One control button has been provided: Power/Reset button • To power on or off the printer. • To reset the printer. WARNING: Do NOT press the Power/Reset button without first following the procedure to stop printing when the printer is busy printing a film.
Drystar AXYS | Introduction | 61 Rear panel At the rear side of the printer, one slot and three connectors are available: USB port slot To insert a USB flash drive for software installation, back-up, etc. Network connector To connect to the hospital network.
62 | Drystar AXYS | Introduction Audio signals The printer gives status information via beeps. The length of the beep indicates the response of the system to a key command. • A short beep means that printer has accepted the key command and is starting the operation.
Drystar AXYS | Introduction | 63 The keypad The keypad is displayed on the touchscreen. Press the keys on the touchscreen to use the keypad funcions. The keypad features the following keys: Key-opera- To access the advanced functions of the Key-opera- tor key tor mode..
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64 | Drystar AXYS | Introduction • To toggle between values in a field. Right key • To scroll forwards through multiple choices within a field. • To move the entry position in a(n) (alpha) nu- merical entry field from left to right.
Drystar AXYS | Introduction | 65 The display The touchscreen has a text display. We distinguish two display types depending on the selected language: • a text display with 4 lines for Western languages (e.g. Dutch, French, Portuguese, Swedish, ...).
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66 | Drystar AXYS | Introduction Operator mode In operator mode, appropriate information is displayed in accordance with the status of the printer. The operator basic screen looks as follows, indicating that the printer is ready for operation and that no job is currently being executed.
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Drystar AXYS | Introduction | 67 • Only (alpha) numerical data can be entered. • During data entry, the field is displayed in reverse mode. • Increment the number in a(n) (alpha) numerical entry field by pressing the Up key. Transition from 9 to 0 of one figure will also increment the next figure to the left, respecting the valid limits of the range.
68 | Drystar AXYS | Introduction Switching on the printer Note: Before switching on the printer, read the safety instructions. Follow the procedure below to ensure proper start-up of the printer and to check that everything is working correctly. 1. Check that the power cord is plugged in and then switch on the printer by pressing the Power/Reset button.
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Drystar AXYS | Introduction | 69 3. Make sure that the printer is loaded with appropriate consumables. Note: If the job status holds a warning or error indication, refer to the section on problem solving. Related Links Safety precautions on page 25...
70 | Drystar AXYS | Introduction Cooling down the printer If owing to certain circumstances (e.g. extensive printing), the temperature rises too much, the printer will cool down automatically. The cooling down message will appaear on the display during the cooling down process.
Drystar AXYS | Introduction | 71 Switching off the printer When you want to switch off the printer, the printer will first finish his current print job. Queued print jobs will be stored on internal media and will be resumed next time the printer is switched on.
72 | Drystar AXYS | Basic Operation (operator mode) Basic Operation (operator mode) This section focuses on the basic operating principles of the printer. After reading this chapter, the operator should be able to produce diagnostic usable hardcopies. No special technical skills are required.
74 | Drystar AXYS | Basic Operation (operator mode) Checking the print queue You can always check the status of the print jobs on a connected remote access PC via the operator menu. Note: Keep in mind that one print job can hold several films to be printed.
Drystar AXYS | Basic Operation (operator mode) | 75 The local print queue screen During printing, the local display shows the ‘print’ screen: • The screen shows information on the job that is currently being printed: the modality name, the time of receipt of the job and the job status (refer to the table below).
76 | Drystar AXYS | Basic Operation (operator mode) Pausing the print queue During printing, you can always pause the print queue by entering the operator menu. During a print job, the ‘print’ screen is displayed: 1. Press the Escape key to enter the operator menu.
Drystar AXYS | Basic Operation (operator mode) | 77 Viewing the film count info During printing, you can always view the number of films left in the trays by entering the operator menu. WARNING: Do not open the input trays to view the number of loaded films...
78 | Drystar AXYS | Basic Operation (operator mode) Viewing the printer status During printing, you can always view the printer status by entering the operator menu. To view the printer status, proceed as follows: During a print job, the ‘print’ screen is displayed: 1.
Drystar AXYS | Basic Operation (operator mode) | 79 Deleting print jobs During printing, you can always delete print jobs by entering the operator menu. To delete a print job, proceed as follows: During a print job, the ‘print’ screen is displayed: 1.
80 | Drystar AXYS | Basic Operation (operator mode) 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). First, the Key-operator has to perform a mechanical modification. After this modification, the ‘film format’...
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Drystar AXYS | Basic Operation (operator mode) | 81 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.
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82 | Drystar AXYS | Basic Operation (operator mode) To position the width format tabs, insert them in the slots and tighten the screws. To position the depth format tab, insert it in the slot and slide it to the right to lock it.
Drystar AXYS | Basic Operation (operator mode) | 83 Loading films This section describes how to load the printer with appropriate films. The printer can be loaded with 8x10”, 10x12”, 11x14”, 14x14” and 14x17” films. Note: If you want to change the film format, the tray configuration must be modified.
84 | Drystar AXYS | Basic Operation (operator mode) When the printer is printing or calculating and an input tray is empty The display shows the following message: 1. Press the Confirm key to start the loading procedure. The following screen appears when the printer is still printing: 2.
Drystar AXYS | Basic Operation (operator mode) | 85 When the printer is in the ready state and an input tray is empty The display shows the following message: 1. Open the lower input tray. 2. Load a new film pack.
86 | Drystar AXYS | Basic Operation (operator mode) Film loading procedure 1. Open the empty input tray. WARNING: To avoid possible film jams, make sure to open input tray all the way. 2. The printer is ready to receive a new film when the following message appears: 3.
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Drystar AXYS | Basic Operation (operator mode) | 87 Note: You can put the film pack onto a table to make manipulation easier. Before you do this, make sure that the table is dust-free! 5. Remove the sticker from the film pack.
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88 | Drystar AXYS | Basic Operation (operator mode) 8. Tear the plastic strip around the film pack. 9. Close the input tray. Note: The printer resumes printing as soon as the tray is closed. Note: Loading instructions are also available on the input tray cover.
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Drystar AXYS | Basic Operation (operator mode) | 89 WARNING: Never reuse a jammed film. 2852E EN 20210601 1655...
90 | Drystar AXYS | Basic Operation (operator mode) Checking the correct position of a film in the input tray You can verify that the film is properly loaded by watching the lower right corner of the films in the input tray. The rounding of this corner should be smaller than the other three corners.
Drystar AXYS | Advanced Operation (key-operator mode) | 91 Advanced Operation (key-operator mode) The printer features the following functions on the main menu level of the Key-operator mode: Menu item Function Show settings To consult the current settings of the printer.
92 | Drystar AXYS | Advanced Operation (key-operator mode) The menu structure General Show settings General Other... Upper input tray Lower input tray Time and date Network(DICOM) Language Image quality Beep on empty tray Logical printers Installed datasets Change settings...
Drystar AXYS | Advanced Operation (key-operator mode) | 93 Quality Control for general radiography applications In order to establish and maintain consistent image quality, a regular evaluation of image quality is advised. The printer contains an automatic QC feature that has been designed to comply with the grayscale reproduction constancy test, according to the international standard IEC 1223-2-4.
94 | Drystar AXYS | Advanced Operation (key-operator mode) Establishing the reference values and verifying image quality After installation of a new printer and before initial use you must establish Quality Control aim values. These values will be used as the base line for comparison when daily Quality Control is done.
Drystar AXYS | Advanced Operation (key-operator mode) | 95 QC test image The QC image has several additional fields where the QC data can be filled in. This image should be filed as part of the QC procedure. The following two examples illustrate a QC test image for a different film format.
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96 | Drystar AXYS | Advanced Operation (key-operator mode) Geometry test Daily density tests Max D Max D Hi D Hi D Mid D Mid D Lo D Lo D Base Base + Fog + Fog Density Difference H i D - L o D )
Drystar AXYS | Advanced Operation (key-operator mode) | 97 Establishing the daily operating reference density levels WARNING: The densitometer of the printer is calibrated at installation. Authorized service personnel should recalibrate the densitometer annually or after major service or repair.
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98 | Drystar AXYS | Advanced Operation (key-operator mode) The printer will automatically print the QC test image. 6. After the image is printed, the system will display the optical density values: The displayed values represent the following steps on the test film:...
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Drystar AXYS | Advanced Operation (key-operator mode) | 99 Mid density 1,2 ± 0,15 High density 2,0 ± 0,2 12. These charts will be used for the daily quality test. Related Links Charts for general radiography QC on page 139...
100 | Drystar AXYS | Advanced Operation (key-operator mode) Establishing the image geometry reference values To establish the image geometry reference values, proceed as follows: 1. Print the QC test image or use the previously printed test image. 2. To determine the reference values for geometry, measure the distances A and B of the geometric square on the test image.
Drystar AXYS | Advanced Operation (key-operator mode) | 101 Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visibility WARNING: Good viewing conditions are important for the correct interpretation of both diagnostic and test images. Make sure that the light box intensity (luminance) is between 2000 and 4000 cd/m²...
102 | Drystar AXYS | Advanced Operation (key-operator mode) Performing quality control (QC) tests The following procedures must be performed daily, weekly or annually as indicated. When used in a mobile application it is required to do a QC after every move.
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Drystar AXYS | Advanced Operation (key-operator mode) | 103 6. Press the Up/Down arrow keys to select the desired tray, followed by the Confirm key. The following screens appear successively: The printer will automatically print the QC test image. After the image is printed, the system will display the optical density values: 7.
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104 | Drystar AXYS | Advanced Operation (key-operator mode) 4000 cd/m² (4500 and 6500 °K). Use a magnifying glass and use shutters to collimate. Make sure the ambient light is low. 1. First, print out the QC test image. 2. Check the QC test image visually for artifacts: no significant disturbing artifacts should be visible.
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Drystar AXYS | Advanced Operation (key-operator mode) | 105 3. Record these values as measured dimensions A and B on Chart 4 (‘Geometric Consistency Control Chart’). 4. Compare the measured A and B dimensions with the reference dimension values, A and B on Chart 4 (‘Geometric Consistency Control Chart’).
106 | Drystar AXYS | Advanced Operation (key-operator mode) Quality Control for mammography application In order to establish and maintain consistent image quality, a regular evaluation of image quality is advised. The printer contains an automatic QC procedure for general radiography applications.
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Drystar AXYS | Advanced Operation (key-operator mode) | 107 • Establishing the image geometry reference values for mammography application • Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visibility for mammography application • Performing quality control (QC) tests for mammography application...
108 | Drystar AXYS | Advanced Operation (key-operator mode) Establishing the reference values and verifying image quality for mammography application After installation of a new printer and before initial use you must establish Quality Control aim values. These values will be used as the base line for comparison when daily Quality Control is done.
Drystar AXYS | Advanced Operation (key-operator mode) | 109 QC test image for mammography application The QC image has several additional fields where the QC data can be filled in. This image should be filed as part of the QC procedure.
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110 | Drystar AXYS | Advanced Operation (key-operator mode) Geometry test Daily density tests Max D Max D Hi D Hi D Mid D Mid D Lo D Lo D Base Base + Fog + Fog Density Difference H i D - L o D )
Drystar AXYS | Advanced Operation (key-operator mode) | 111 Establishing the daily operating reference density levels for mammography application WARNING: The densitometer of the printer is calibrated at installation. Authorized service personnel should recalibrate the densitometer annually or after major service or repair.
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112 | Drystar AXYS | Advanced Operation (key-operator mode) The printer will automatically print the QC test image. 6. After the image is printed, the system will display the optical density values: The displayed values represent the following steps on the test film:...
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Drystar AXYS | Advanced Operation (key-operator mode) | 113 Mid density 1.35 ± 0.15 High density 2.35 ± 0.15 12. These charts will be used for the daily quality test. Related Links Preventive maintenance schedule on page 120 Charts for mammography QC...
114 | Drystar AXYS | Advanced Operation (key-operator mode) Establishing the image geometry reference values for mammography application To establish the image geometry reference values, proceed as follows: 1. Print the QC mammography test image or use the previously printed test image.
Drystar AXYS | Advanced Operation (key-operator mode) | 115 Verifying Acceptable Spatial Resolution, Artifact Levels and Low Contrast Visibility for mammography application WARNING: Good viewing conditions are important for the correct interpretation of both diagnostic and test images. Make sure that the light box intensity (luminance) is between 3000 and 6000 cd/m²...
116 | Drystar AXYS | Advanced Operation (key-operator mode) Performing quality control (QC) tests for mammography application The following procedures must be performed daily, weekly or annually as indicated. When used in a mobile application it is required to do a QC after every move.
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Drystar AXYS | Advanced Operation (key-operator mode) | 117 5. Define the tray for printing. The ‘Select tray’ screen appears: 6. Press the Up/Down arrow keys to select the desired tray, followed by the Confirm key. The following screens appear successively: The printer will automatically print the QC test image.
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118 | Drystar AXYS | Advanced Operation (key-operator mode) WARNING: Good viewing conditions are important for the correct interpretation of both diagnostic and test images. Make sure that the light box intensity (luminance) is 3000 and 6000 cd/m² (4500 and 6500 °K) for mammography. Use a magnifying glass and use shutters to collimate.
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Drystar AXYS | Advanced Operation (key-operator mode) | 119 WARNING: Make sure to measure distance A from the left edge of the left line to the right edge of the right line and distance B from the upper edge of the upper line to the lower edge of the lower line.
120 | Drystar AXYS | Preventive maintenance schedule Preventive maintenance schedule The printer is designed for trouble-free operation. Maintenance and cleaning involve only some minor user tasks. Refer to the following pages for the appropriate cleaning procedure. Interval What to do? Ad hoc ‘Cleaning and disinfection’...
Drystar AXYS | Preventive maintenance schedule | 121 Safety guidelines WARNING: To prevent damage to the printer while performing maintenance, observe the following safety precautions: • Do not lubricate the printer. • Do not attempt to disassemble the printer. • Do not touch the resistor line of the print head.
122 | Drystar AXYS | Preventive maintenance schedule Cleaning and disinfection All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and device. All existing universal precautions should be taken to avoid that the digitizer comes into contact with potential contaminations.
Drystar AXYS | Preventive maintenance schedule | 123 Cleaning the print head WARNING: Print head cleaning must be done when image quality problems occur. To clean the print head: 1. Press the Key-operator key to enter the Key-operator mode. 2. On the Key-operator main menu, press the Down key five times, followed by the Confirm key to select ‘Calibration’.
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124 | Drystar AXYS | Preventive maintenance schedule 7. Open the hold-down bracket. 8. Open the print head unit. WARNING: The print head unit can be warm. 9. Locate and check on sight the print head resistor line. 2852E EN 20210601 1655...
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Drystar AXYS | Preventive maintenance schedule | 125 Note: Be careful not to touch the print head resistor line with your fingers 10. Clean the print head resistor line. Gently pass over the resistor line a few times with a lint free cloth, slightly moistened with Isopropyl alcohol or Ethanol.
126 | Drystar AXYS | Preventive maintenance schedule Calibrating the touchscreen To detect the exact position of your finger on the touchscreen, the touchscreen must be calibrated. The calibration can be repeated regularly to keep the touchscreen accurate. 1. Press and hold the text display of the touchscreen for 7 seconds.
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Drystar AXYS | Preventive maintenance schedule | 127 Figure 8: Calibration screen 3. Press the indicated point on the touchscreen as precise as possible. The third calibration screen is displayed. Figure 9: Calibration screen 4. Press the indicated point on the touchscreen as precise as possible.
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128 | Drystar AXYS | Preventive maintenance schedule 5. Press the OK button on the touchscreen. 2852E EN 20210601 1655...
Drystar AXYS | Remarks for HF-emission and immunity | 129 Remarks for HF-emission and immunity This device is intended for operation in the electromagnetic environment given below. The user of the device should ensure that it is used in such an environment.
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130 | Drystar AXYS | Remarks for HF-emission and immunity in accordance + 15 kV air dis- + 15 kV air dis- concrete or ce- with IEC charge charge ramic tiles. The 610004-2 relative humidi- ty must be at least 30%, if the...
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Drystar AXYS | Remarks for HF-emission and immunity | 131 accordance with the typical val- IEC 61000-4-8 ues as they are in a commercial and clinical environ- ment. REMARK : U is the alternating current in the network before the application of the test level.
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132 | Drystar AXYS | Remarks for HF-emission and immunity d = 2.3 800 MHz to 2.5 GHz With P as the rated power of the transmit- ter in watts (W) in ac- cordance with the manufacturer infor- mation on the trans-...
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Drystar AXYS | Remarks for HF-emission and immunity | 133 This device is intended for operation in an electromagnetic environment in which the radiated high frequency disturbance variables are monitored. The user of the device can help to prevent electromagnetic...
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134 | Drystar AXYS | Remarks for HF-emission and immunity • Cables, transducers and accessories 2852E EN 20210601 1655...
Drystar AXYS | Remarks for HF-emission and immunity | 135 Immunity to RF wireless communication equipment Service ISM Band Distance Immunity test level (MHz) (V/m) 300-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787 LTE Band 13, 17 800-960 GSM 800/900; TETRA 800, IDEN 820;...
136 | Drystar AXYS | Remarks for HF-emission and immunity Precautions on EMC WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Drystar AXYS | Remarks for HF-emission and immunity | 137 Cables, transducers and accessories Cables, transducers and accessories which were tested and found to comply with the collateral standard IEC60601-1-2 (EMC): Caution: Using cables and accessories not mentioned in this...
138 | Drystar AXYS | Quality Control Charts Quality Control Charts Topics: • Charts for general radiography QC • Charts for mammography QC 2852E EN 20210601 1655...
Drystar AXYS | Quality Control Charts | 139 Charts for general radiography QC Quality Control for Chart 1 General radiography applications Determination of Operating Levels Imager Type: __________ Serial #: _________________ Date ____________________ Film Type: ____________ Emulsion #: ______________ Input Tray: _______________ Densitometer: ________________ (default selection) Step 1: Print QC Test images on five consecutive days.
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140 | Drystar AXYS | Quality Control Charts Quality Control for Chart 2A General radiography applications Daily Density Control Chart Imager Type: __________ Serial #: _____________ Film Type:____________ Emul #:___________ Input Tray: ________ Densitometer Internal: ____________ (default selection) Da te :...
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Drystar AXYS | Quality Control Charts | 141 Quality Control for Chart 2B General radiography applications Daily Density Control Chart Imager Type: __________ Serial #: _____________ Film Type:____________ Emul #:___________ Densitometer Internal: _____________ (default selection) Input Tray: ________ High Density Upper Control limit = +0.20...
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142 | Drystar AXYS | Quality Control Charts Quality Control for Chart 3 General radiography applications Artifacts and Spatial Resolution Control Chart Test Frequency: Weekly Serial # _____________ Input Tray: ____________ Initial Reference Test Date Initial Reference Artifacts Initial Reference Dot Visibility...
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Drystar AXYS | Quality Control Charts | 143 Quality Control for Chart 4 General radiography applications Geometric Consistency Control Chart Test Frequency: Annually or as required Serial # ______________ Input Tray: _______________________ Reference Dimensions Measured Dimensions Consistency Aspect Ratio Date:...
144 | Drystar AXYS | Quality Control Charts Charts for mammography QC Figure 16: Chart 1, Determination of Operating Levels 2852E EN 20210601 1655...
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Drystar AXYS | Quality Control Charts | 145 Quality Control for Chart 2A Mammography applications Daily Density Control Chart Imager Type: __________ Serial #: _____________ Film Type:____________ Emul #:___________ Densitometer: _________________ (default selection) Input Tray: ________ Da te : Initia ls : Upper Control limit = +0.03...
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146 | Drystar AXYS | Quality Control Charts Quality Control for Chart 2B Mammography applications Daily Density Control Chart Imager Type: __________ Serial #: _____________ Film Type:____________ Emul #:___________ Densitometer: _________________ (default selection) Input Tray: ________ Da te : Initia ls :...
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Drystar AXYS | Quality Control Charts | 147 Quality Control for Chart 3 Mammography applications Artifacts and Spatial Resolution Control Chart Test Frequency: Weekly Serial # _____________ Input Tray: ____________ Initial Reference Test Date Initial Reference Artifacts Initial Reference Dot Visibility...
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148 | Drystar AXYS | Quality Control Charts Quality Control for Chart 4 Mammography applications Geometric Consistency Control Chart Test Frequency: Annually or as required Serial # ___________ Input Tray: ______________________ Reference Dimensions Measured Dimensions Consistency Aspect Ratio Date: Date:...
Drystar AXYS | Plug & Play Installation Manual | 149 Plug & Play Installation Manual The Plug & Play Manual is intended for both the printers with one and with two trays. The operation is identical for each input tray.
150 | Drystar AXYS | Plug & Play Installation Manual Contents of the packages Power cord set (order separately) Network cable Printer Set of documents User documentation Figure 21: Contents of the packages Crosshead screwdriver Flathead screwdriver Wire cutter Figure 22: Required tools (not included)
Drystar AXYS | Plug & Play Installation Manual | 153 Remove the printer from the pallet Note: Locate 2 handles at left, front and right side. If only 2 persons are available, lift as Lift printer from pallet with 3 persons.
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154 | Drystar AXYS | Plug & Play Installation Manual 3. Put printer on a table. Always put tray side at front. WARNING: The table should be able to support the printer’s full weight (90 kg). 2852E EN 20210601 1655...
Drystar AXYS | Plug & Play Installation Manual | 155 Unpack the accessories 1. Check all accessories. Note: Refer to the Packing slip for a complete list of accessories. 2. Return the packing material. Wood P a pe r P la s tic...
156 | Drystar AXYS | Plug & Play Installation Manual Environment specifications Environment requirements • Ventilated room, • away from direct sunlight, • away from sources of dust, humidity, heat and cold, • room temperature between 15°C (50°F) and 30°C (86°F), •...
Drystar AXYS | Plug & Play Installation Manual | 157 Remove the transport protections 1. Mount the 2 tray supports at the underside of the output tray. 2. Install output tray. 3. Open top cover. 4. Take wire cutter. 2852E EN 20210601 1655...
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158 | Drystar AXYS | Plug & Play Installation Manual 5. Cut 3 red straps. 6. Open hold-down bracket. 7. Open print head. 8. Remove foam sheet. 2852E EN 20210601 1655...
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Drystar AXYS | Plug & Play Installation Manual | 159 9. Close print head. 10. Close hold-down bracket until you hear a click. 11. Remove 3 screws from left side panel. 12. Lift up side panel. 2852E EN 20210601 1655...
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160 | Drystar AXYS | Plug & Play Installation Manual 13. Remove orange screw. The belt tightens itself. 14. Reinstall side cover. Slide bottom into slots. 15. Tighten 3 screws. 16. Close top cover. 2852E EN 20210601 1655...
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Drystar AXYS | Plug & Play Installation Manual | 161 2852E EN 20210601 1655...
162 | Drystar AXYS | Plug & Play Installation Manual Connect the cables WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING: When installing the printer, care must be taken to ensure that...
Drystar AXYS | Plug & Play Installation Manual | 163 Verify film position tabs Note: Only change the tray configuration if the user needs another tray configuration. 1. Verify that position tabs of upper tray are configurated for 14x17” films.
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164 | Drystar AXYS | Plug & Play Installation Manual 4. Put film position tab in place and push down until it locks. 5. Tighten the screws of the width format tabs. Note: Note that there is a screw to secure the position of the 10”...
Drystar AXYS | Plug & Play Installation Manual | 165 Load film in the input trays 1. Open film box. 2. Take film pack and remove sticker. 3. Remove plastic film bag partially. 4. Slide film pack into tray and remove plastic film bag completely.
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166 | Drystar AXYS | Plug & Play Installation Manual 6. Close upper (lower) input tray. 7. Stick film ID-label to tray handle. 2852E EN 20210601 1655...
Drystar AXYS | Plug & Play Installation Manual | 167 Startup the printer 1. Press the POWER button. A startup screen is displayed on the touchscreen. After startup, the following message is displayed. After a short while, a progress indicator will show the progress of the self-test.
168 | Drystar AXYS | Plug & Play Installation Manual Configure network settings The printer is configured with the following APIPA addresses: Printer IP address: 169.254.10.10 Subnet mask: 255.255.0.0 Ask your network manager the following information: Printer IP address: Netmask:...