AGFA Crystal Imager User Manual
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AGFA Crystal Imager User Manual

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Crystal Imager
5366/300
User Manual
3831B EN 20210601 1655

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Summary of Contents for AGFA Crystal Imager

  • Page 1 Crystal Imager 5366/300 User Manual 3831B EN 20210601 1655...

  • Page 2: Table Of Contents

    | Crystal Imager | Contents Contents Legal Notice ................5 About the safety notices in this document ......6 Crystal Imager ............... 7 Scope .................8 Intended use ..............9 Available Software versions ........10 Film types ..............11 Labeling the input trays ........11...
  • Page 3 Crystal Imager | Contents | iii Operator mode ..........51 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...
  • Page 4 | Crystal Imager | Contents Cleaning the print head ..........109 Calibrating the touchscreen ........112 Remarks for HF-emission and immunity ......115 Immunity to RF wireless communication equipment ..Precautions on EMC ..........122 Cables, transducers and accessories ....... 123 Quality Control Charts ............

  • Page 5: Legal Notice

    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.

  • Page 6: About The Safety Notices In This Document

    6 | Crystal Imager | 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:...

  • Page 7: Crystal Imager

    Crystal Imager | Crystal Imager | 7 Crystal Imager Topics: • Scope • Intended use • Available Software versions • Film types • Specifications • Product Complaints • Disclaimer 3831B EN 20210601 1655...

  • Page 8: Scope

    8 | Crystal Imager | Crystal Imager 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.

  • Page 9: Intended Use

    The Crystal Imager can be used for general radiography only. It cannot be used for the mammography application. The Crystal Imager is designed for high throughput and for use as a central printer. 3831B EN 20210601 1655...

  • Page 10: Available Software Versions

    10 | Crystal Imager | Crystal Imager Available Software versions The table below lists the available software versions and the type of printer they require: Software Printer version (SW) 1.8.x supports Drystar 5302 1.9.x supports Drystar 5302 (RoHS compliant) supports both Drystar 5302 & Drystar AXYS 2.1 and 2.2...

  • Page 11: Film Types

    Crystal Imager | Crystal Imager | 11 Film types Film Film base Application Film sizes Average optical type density (X-Rite 310 densi- tometer) blue-trans- General Radi- 8x10”, 10x12”, CF-B parent ography 11x14”, 14x14”, and 14x17” The printer has 2 input trays. Both trays can handle all listed film types and formats.
  • Page 12 12 | Crystal Imager | Crystal Imager 3831B EN 20210601 1655...

  • Page 13: Specifications

    Crystal Imager | Crystal Imager | 13 Specifications Product description Type of product Printer Crystal Imager Commercial name 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,...
  • Page 14 14 | Crystal Imager | Crystal Imager 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...
  • Page 15 Crystal Imager | Crystal Imager | 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)
  • Page 16 16 | Crystal Imager | Crystal Imager 4358 346.03 4303 341.66 14x17” 14” dimensions 17” dimensions pixels pixels 4358 346.03 5232 415.42 3831B EN 20210601 1655...

  • Page 17: Product Complaints

    Crystal Imager | Crystal Imager | 17 Product Complaints Any health care professional (for example a customer or a user) who has any complaints or has experienced any dissatisfaction with the quality, durability, reliability, safety, effectiveness, or performance of this product must notify iCRco.

  • Page 18: Disclaimer

    18 | Crystal Imager | Crystal Imager 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.

  • Page 19: Introduction

    Crystal Imager | Introduction | 19 Introduction Topics: • Intended user • Features • Equipment Classification • Safety precautions • Security precautions • Installation • Training • Compliance • Connectivity • Labels • Power cord regulations • Patient data security •...

  • Page 20: Intended User

    20 | Crystal Imager | 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.

  • Page 21: Features

    Crystal Imager | 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.
  • Page 22 22 | Crystal Imager | Introduction A#Sharp label Topics: • Network features • Software license information • Options and accessories 3831B EN 20210601 1655...

  • Page 23: Network Features

    Crystal Imager | 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.

  • Page 24: Equipment Classification

    24 | Crystal Imager | 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.

  • Page 25: Safety Precautions

    Crystal Imager | 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.
  • Page 26 26 | Crystal Imager | 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.

  • Page 27: Labels

    Crystal Imager | 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.
  • Page 28 28 | Crystal Imager | Introduction 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.
  • Page 29 Crystal Imager | Introduction | 29 Do not sit Warning Indicates that sitting on a component can cause damage to the equipment. 3831B EN 20210601 1655...

  • Page 30: Transport After Installation

    30 | Crystal Imager | 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.
  • Page 31 Crystal Imager | 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.

  • Page 32: Environmental Protection

    32 | Crystal Imager | 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.

  • Page 33: Restriction Of The Use Of Certain Hazardous Substances (Rohs)

    Crystal Imager | 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.

  • Page 34: Security Precautions

    34 | Crystal Imager | Introduction 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.

  • Page 35: Installation

    Crystal Imager | Introduction | 35 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.

  • Page 36: Training

    36 | Crystal Imager | Introduction 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.

  • Page 37: Compliance

    Crystal Imager | Introduction | 37 Compliance Topics: • General • Safety • Electromagnetic Compatibility • Seismic (earthquake) requirements 3831B EN 20210601 1655...

  • Page 38: General

    38 | Crystal Imager | Introduction 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.

  • Page 39: Seismic (Earthquake) Requirements

    Crystal Imager | Introduction | 39 • Canada: This class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. • EC: This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures.

  • Page 40: Connectivity

    40 | Crystal Imager | Introduction 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.

  • Page 41: Labels

    Crystal Imager | Introduction | 41 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.
  • Page 42 42 | Crystal Imager | Introduction • The controller (image source, date, time, etc.). For more detailed information, refer to the Service documentation. 3831B EN 20210601 1655...

  • Page 43: Power Cord Regulations

    Crystal Imager | Introduction | 43 Power cord regulations • Use attached power cord set to the product. • Do not use attached power cord set for other electric equipment. 3831B EN 20210601 1655...

  • Page 44: Patient Data Security

    44 | Crystal Imager | 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.

  • Page 45: Storage Media

    Crystal Imager | 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.

  • Page 46: Node Authentication, Certificates And Certification Authority

    46 | Crystal Imager | 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’...

  • Page 47: Requirements On The Operating Environment

    (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.
  • Page 48 48 | Crystal Imager | 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.

  • Page 49: Operating Modes

    Crystal Imager | 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 •...

  • Page 50: Control Modes (Local And Remote)

    50 | Crystal Imager | 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.

  • Page 51: Operator Mode

    Crystal Imager | 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.

  • Page 52: Key-Operator Mode

    52 | Crystal Imager | 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.

  • Page 53: Service Mode

    Crystal Imager | 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. 3831B EN 20210601 1655...

  • Page 54: Specialist Mode

    54 | Crystal Imager | 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. 3831B EN 20210601 1655...

  • Page 55: Administrator Mode

    Crystal Imager | 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. 3831B EN 20210601 1655...

  • Page 56: The Local User Interface

    56 | Crystal Imager | 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...
  • Page 57 Crystal Imager | Introduction | 57 • The display 3831B EN 20210601 1655...

  • Page 58: Messages

    58 | Crystal Imager | 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.

  • Page 59: The Status Indicator Led

    Crystal Imager | 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.

  • Page 60: The Control Buttons

    60 | Crystal Imager | 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.

  • Page 61: Rear Panel

    Crystal Imager | 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.

  • Page 62: Audio Signals

    62 | Crystal Imager | 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.

  • Page 63: The Keypad

    Crystal Imager | 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..
  • Page 64 64 | Crystal Imager | 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.

  • Page 65: The Display

    Crystal Imager | 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, ...).
  • Page 66 66 | Crystal Imager | 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.
  • Page 67 Crystal Imager | 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.

  • Page 68: Switching On The Printer

    68 | Crystal Imager | 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.
  • Page 69 Crystal Imager | 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...

  • Page 70: Cooling Down The Printer

    70 | Crystal Imager | 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.

  • Page 71: Switching Off The Printer

    Crystal Imager | 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.

  • Page 72: Basic Operation (Operator Mode)

    72 | Crystal Imager | 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.

  • Page 73: Managing The Print Queue

    Crystal Imager | Basic Operation (operator mode) | 73 Managing the print queue Topics: • Checking the print queue • The local print queue screen 3831B EN 20210601 1655...

  • Page 74: Checking The Print Queue

    74 | Crystal Imager | 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.

  • Page 75: The Local Print Queue Screen

    Crystal Imager | 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).

  • Page 76: Pausing The Print Queue

    76 | Crystal Imager | 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.

  • Page 77: Viewing The Film Count Info

    Crystal Imager | 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...

  • Page 78: Viewing The Printer Status

    78 | Crystal Imager | 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.

  • Page 79: Deleting Print Jobs

    Crystal Imager | Basic Operation (operator mode) | 79 Deleting print jobs Note: You can only remove print jobs from the print queue via the remote browser interface (remote operator mode). 3831B EN 20210601 1655...

  • Page 80: Changing The Film Format Of The Trays

    80 | Crystal Imager | 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’...
  • Page 81 Crystal Imager | 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.
  • Page 82 82 | Crystal Imager | 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.

  • Page 83: Loading Films

    Crystal Imager | 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.

  • Page 84: When The Printer Is Printing Or Calculating And An Input Tray Is Empty

    84 | Crystal Imager | 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.

  • Page 85: When The Printer Is In The Ready State And An Input Tray Is Empty

    Crystal Imager | 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.

  • Page 86: Film Loading Procedure

    86 | Crystal Imager | 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.
  • Page 87 Crystal Imager | 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.
  • Page 88 88 | Crystal Imager | 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.
  • Page 89 Crystal Imager | Basic Operation (operator mode) | 89 WARNING: Never reuse a jammed film. 3831B EN 20210601 1655...

  • Page 90: Checking The Correct Position Of A Film In The Input Tray

    90 | Crystal Imager | 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.

  • Page 91: Advanced Operation (Key-Operator Mode)

    Crystal Imager | 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.

  • Page 92: The Menu Structure

    92 | Crystal Imager | 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...

  • Page 93: Quality Control

    Crystal Imager | Advanced Operation (key-operator mode) | 93 Quality Control 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.

  • Page 94: Establishing The Reference Values And Verifying Image Quality

    94 | Crystal Imager | 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.

  • Page 95: Qc Test Image

    Crystal Imager | 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.
  • Page 96 96 | Crystal Imager | 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 )

  • Page 97: Establishing The Daily Operating Reference Density Levels

    Crystal Imager | 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.
  • Page 98 98 | Crystal Imager | 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:...
  • Page 99 Crystal Imager | 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 Quality Control Charts on page 124 Preventive maintenance schedule...

  • Page 100: Establishing The Image Geometry Reference Values

    100 | Crystal Imager | 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.

  • Page 101: Verifying Acceptable Spatial Resolution, Artifact Levels And Low Contrast Visibility

    Crystal Imager | 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...

  • Page 102: Performing Quality Control (Qc) Tests

    102 | Crystal Imager | 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.
  • Page 103 Crystal Imager | 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.
  • Page 104 104 | Crystal Imager | 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.
  • Page 105 Crystal Imager | Advanced Operation (key-operator mode) | 105 4. Compare the measured A and B dimensions with the reference dimension values, A and B on Chart 4 (‘Geometric Consistency Control Chart’). The differences between measured dimensions of A and B and the...

  • Page 106: Preventive Maintenance Schedule

    106 | Crystal Imager | 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’...

  • Page 107: Safety Guidelines

    Crystal Imager | Preventive maintenance schedule | 107 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.

  • Page 108: Cleaning And Disinfection

    108 | Crystal Imager | 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.

  • Page 109: Cleaning The Print Head

    Crystal Imager | Preventive maintenance schedule | 109 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’.
  • Page 110 110 | Crystal Imager | 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. 3831B EN 20210601 1655...
  • Page 111 Crystal Imager | Preventive maintenance schedule | 111 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.

  • Page 112: Calibrating The Touchscreen

    112 | Crystal Imager | 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.
  • Page 113 Crystal Imager | Preventive maintenance schedule | 113 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.
  • Page 114 114 | Crystal Imager | Preventive maintenance schedule 5. Press the OK button on the touchscreen. 3831B EN 20210601 1655...

  • Page 115: Remarks For Hf-Emission And Immunity

    Crystal Imager | Remarks for HF-emission and immunity | 115 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.
  • Page 116 116 | Crystal Imager | 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...
  • Page 117 Crystal Imager | Remarks for HF-emission and immunity | 117 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.
  • Page 118 118 | Crystal Imager | 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-...
  • Page 119 Crystal Imager | Remarks for HF-emission and immunity | 119 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...
  • Page 120 120 | Crystal Imager | Remarks for HF-emission and immunity • Cables, transducers and accessories 3831B EN 20210601 1655...
  • Page 121 Crystal Imager | Remarks for HF-emission and immunity | 121 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;...

  • Page 122: Precautions On Emc

    122 | Crystal Imager | 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.

  • Page 123: Cables, Transducers And Accessories

    Crystal Imager | Remarks for HF-emission and immunity | 123 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...

  • Page 124: Quality Control Charts

    124 | Crystal Imager | Quality Control Charts Quality Control Charts Quality Control for Chart 1 General radiography applications Determination of Operating Levels Imager Type: __________ Serial #: _________________ Date ____________________ Input Tray: _______________ Film Type: ____________ Emulsion #: ______________ Densitometer: ________________ (default selection) Step 1: Print QC Test images on five consecutive days.
  • Page 125 Crystal Imager | Quality Control Charts | 125 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 :...
  • Page 126 126 | Crystal Imager | Quality Control Charts 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...
  • Page 127 Crystal Imager | Quality Control Charts | 127 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...
  • Page 128 128 | Crystal Imager | Quality Control Charts 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:...

  • Page 129: Plug & Play Installation Manual

    Crystal Imager | Plug & Play Installation Manual | 129 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.

  • Page 130: Contents Of The Packages

    130 | Crystal Imager | Plug & Play Installation Manual Contents of the packages Power cord set (order separately) Network cable Printer Set of documents User documentation Figure 16: Contents of the packages Crosshead screwdriver Flathead screwdriver Wire cutter Figure 17: Required tools (not included)

  • Page 131: Remove The Packing Materials

    Crystal Imager | Plug & Play Installation Manual | 131 Remove the packing materials Remove the packing materials Remove box containing country specific Remove accessories box. accessories. 1. Remove accessories box. Remove the packing materials e packing materials Remove box containing country specific Remove accessories box.
  • Page 132 132 | Crystal Imager | Plug & Play Installation Manual Remove plastic bag. 4/18 2832E EN 20151008 3831B EN 20210601 1655...

  • Page 133: Remove The Printer From The Pallet

    Crystal Imager | Plug & Play Installation Manual | 133 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.
  • Page 134 134 | Crystal Imager | 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). 3831B EN 20210601 1655...

  • Page 135: Unpack The Accessories

    Crystal Imager | Plug & Play Installation Manual | 135 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...

  • Page 136: Environment Specifications

    136 | Crystal Imager | 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), •...

  • Page 137: Remove The Transport Protections

    Crystal Imager | Plug & Play Installation Manual | 137 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. 3831B EN 20210601 1655...
  • Page 138 138 | Crystal Imager | Plug & Play Installation Manual 5. Cut 3 red straps. 6. Open hold-down bracket. 7. Open print head. 8. Remove foam sheet. 3831B EN 20210601 1655...
  • Page 139 Crystal Imager | Plug & Play Installation Manual | 139 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. 3831B EN 20210601 1655...
  • Page 140 140 | Crystal Imager | 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. 3831B EN 20210601 1655...
  • Page 141 Crystal Imager | Plug & Play Installation Manual | 141 3831B EN 20210601 1655...

  • Page 142: Connect The Cables

    142 | Crystal Imager | 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...

  • Page 143: Verify Film Position Tabs

    Crystal Imager | Plug & Play Installation Manual | 143 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.
  • Page 144 144 | Crystal Imager | 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”...

  • Page 145: Load Film In The Input Trays

    Crystal Imager | Plug & Play Installation Manual | 145 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.
  • Page 146 146 | Crystal Imager | Plug & Play Installation Manual 6. Close upper (lower) input tray. 7. Stick film ID-label to tray handle. 3831B EN 20210601 1655...

  • Page 147: Startup The Printer

    Crystal Imager | Plug & Play Installation Manual | 147 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.

  • Page 148: Configure Network Settings

    148 | Crystal Imager | 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:...

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