AGFA 5366/300 User Manual Download Page 37

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Compliance

Topics:

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General

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Safety

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Electromagnetic Compatibility

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Seismic (earthquake) requirements

Crystal Imager | Introduction |

3831B EN 20210601 1655

Summary of Contents for 5366/300

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

Page 2: ...er installation 30 Environmental protection 32 Restriction of the Use of Certain Hazardous Substances RoHS 33 Security precautions 34 Installation 35 Training 36 Compliance 37 General 38 Safety 38 Electromagnetic Compatibility 38 Seismic earthquake requirements 39 Connectivity 40 Safety compliance 40 Labels 41 Viewing the System info area on a film 41 Power cord regulations 43 Patient data securit...

Page 3: ...g films 83 When the printer is printing or calculating and an input tray is empty 84 When the printer is in the ready state and an input tray is empty 85 Film loading procedure 86 Checking the correct position of a film in the input tray 90 Advanced Operation key operator mode 91 The menu structure 92 Quality Control 93 Establishing the reference values and verifying image quality 94 QC test image...

Page 4: ... Charts 124 Plug Play Installation Manual 129 Contents of the packages 130 Remove the packing materials 131 Remove the printer from the pallet 133 Unpack the accessories 135 Environment specifications 136 Remove the transport protections 137 Connect the cables 142 Verify film position tabs 143 Load film in the input trays 145 Startup the printer 147 Configure network settings 148 iv Crystal Imager...

Page 5: ...oducts and services may not be available for your local area Please contact your local sales representative for availability information Agfa NV diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa NV shall under no circumstances be liable for any damage arising from the use or inability to use any information apparatus met...

Page 6: ...UTION A caution safety notice indicates a hazardous situation which can lead to a potential minor injury to a user engineer patient or any other person An instruction is a direction which if it is not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution A prohibition is a direction which if it is not followed can ...

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

Page 8: ...he printer for information for the advanced operation of the printer Figure 1 Example of the type label Type label For product information training support service or product complaints related to Crystal Imager contact iCRco iCRco 2580 West 237th Street Torrance CA 90505 Phone 310 921 9559 Fax 310 542 7236 8 Crystal Imager Crystal Imager 3831B EN 20210601 1655 ...

Page 9: ...inch 11x14 inch 14x14 inch and 14x17 inch of blue based CF B film and offers crisp dense grayscale images 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 Crystal Imager Crystal Imager 9 3831B EN 20210601 1655 ...

Page 10: ... 4 0 support of additional printer models 5 0 support for single tray models Supports Sata Dom Supports Spare Parts without E lables 5 1 support of additional printer models 6 0 required for devices with serial number higher than 100000 6 1 is a maintenance software supports DRY IMAGER 6 1 x maintenance software 6 2 is needed for new Devnix PCB index 16 and higher 6 2 1 maintenance software 6 2 2 ...

Page 11: ...d the Film Identification tag is read and the printer settings are automatically adjusted The Key operator can overrule the film settings for the input tray Labeling the input trays Note If you want to change the film format the tray configuration must be modified Appropriate labels have been applied on the input tray s by the service personnel at installation of the printer indicating the type of...

Page 12: ...12 Crystal Imager Crystal Imager 3831B EN 20210601 1655 ...

Page 13: ...pprox 90 kg Packed approx 128 kg RAM memory 1 Gb Internal mass storage media Approx 12 Gb External mass storage media USB flash drive Electrical connection Rated voltage 100 120 V 220 240 V AC Rated current 4 A 100 120 V 2 A 220 240 V No external main fuses Mains frequency 50 60 Hz Network connectivity Ethernet connectors RJ45 twisted pair for 10 100 1000 Base TX Network protocols TCP IP serv ices...

Page 14: ... altitude on site 3000 m to 0 m Environmental storage conditions Climate conditions for storage are in accordance with EN60721 3 1 class 1K4 Room temperature Between 25 C and 55 C storage Relative humidity Between 10 and 100 Absolute humidity Between 0 1 g m3 and 35 g m3 Rate of change of temperature 1 C min Atmospheric pressure 70 kPa 106 kPa Environmental transport conditions Climate conditions ...

Page 15: ...d and main tained according to Agfa instruc tions 5 years Service interventions Max 2 interventions 3 years Earthquake standard Meets the CA requirements Imaging Array Diagnostic area 8x10 8 dimensions 10 dimensions pixels mm pixels mm 2376 188 65 3070 243 76 10x12 10 dimensions 12 dimensions pixels mm pixels mm 3070 243 76 3653 290 05 11x14 11 dimensions 14 dimensions pixels mm pixels mm 3348 265...

Page 16: ...4358 346 03 4303 341 66 14x17 14 dimensions 17 dimensions pixels mm pixels mm 4358 346 03 5232 415 42 16 Crystal Imager Crystal Imager 3831B EN 20210601 1655 ...

Page 17: ... or performance of this product must notify iCRco If during the use of this device or as a result of its use a serious incident has occurred please report it to the manufacturer and or its authorised representative and to your national authority Manufacturer address iCRco 2580 West 237th Street Torrance CA 90505 Phone 310 921 9559 Fax 310 542 7236 Crystal Imager Crystal Imager 17 3831B EN 20210601...

Page 18: ...ssions that may appear in this document To improve reliability function or design Agfa reserves the right to change the product without further notice This manual is provided without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Note In the United States Federal law restricts this device on orde...

Page 19: ...Security precautions Installation Training Compliance Connectivity Labels Power cord regulations Patient data security Operating modes The local user interface Switching on the printer Cooling down the printer Switching off the printer Crystal Imager Introduction 19 3831B EN 20210601 1655 ...

Page 20: ...ually 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 20 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 21: ...olution each pixel with 14 bit contrast resolution Multiple film formats can be used Any combination of two film formats can be used on line Both input trays can be adjusted for all film formats The input trays are equipped with an RF tag reader which automatically traces the films used in the printer and protects the printer when detecting non identified media Number of input trays The printer is...

Page 22: ...1 A Sharp label Topics Network features Software license information Options and accessories 22 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 23: ... www apache org licenses LICENSE Options and accessories Mobile Earthquake provisions Hardware The OPTIONAL mobile earthquake installation kit allows you to use the printer in a van or to use it in unstable environment It contains the necessary equipment to fix the printer onto a table and has provisions for easy service access The mobile earthquake installation kit is delivered with the necessary...

Page 24: ...assified The patient does not get in contact with any part of the equipment Water ingress This device does not have protection against in gress of water Cleaning See section on cleaning and disinfecting Disinfection See section on cleaning and disinfecting Flammable anesthetics This device is not suitable for use in the presence of a flammable anesthetic mixture with air or in presence of a flamma...

Page 25: ...ions maintenance or repairs are carried out by a certified field service engineer A non certified engineer performing a modification or service intervention on a medical device acts on his own responsibility and makes the warranty void WARNING System unavailability due to hardware or software failure If the product is used in critical clinical workflows a backup system has to be foreseen WARNING A...

Page 26: ... the power cord from the outlet before carrying out any maintenance work CAUTION Strictly observe all warnings cautions notes and safety markings within this document and on the product The classification of this product according to the medical electrical equipment standard IEC 60601 1 requires installation outside the patient vicinity For definition of patient vicinity see dimensions below 1 R 1...

Page 27: ...n all configurations must comply with the medical electrical systems standard IEC 60601 1 2 The party that makes the connections acts as system configurator and is responsible for complying with the systems standard If required contact your local service organization Caution hot Keep hands clear from the thermal print head In order to reduce the risk of electric shock do not remove any covers Prot...

Page 28: ... transmitter module that generates non ioniz ing radiation Warning labels The following samples illustrate some of the warning labels ISO 3864 Safety Signs define the design principles for international safety signs that may appear on the medical equipment Symbol Explanation Dangerous voltage Ionizing radiation Hot Surface Warning Indicates that touching the part indicated can cause burns Laser Wa...

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

Page 30: ...top have to be taken into account The printer should not be placed on a soft surface since this might prevent appropriate ventilation and cause overheating Make sure the printer is placed on a stable hard surface table WARNING The appliance may not be transported continuously from one location to the other WARNING The printer should be transported by 3 persons or if not possible with 2 Refer to th...

Page 31: ...own below 2 If only 2 persons are available lift as shown below Figure 2 Transport possibilities Transporting the printer 1 Switch off the printer 2 Disconnect the cables 3 Move the printer to its destination with 2 preferably 3 persons 4 Reconnect the cables 5 Switch the printer on Crystal Imager Introduction 31 3831B EN 20210601 1655 ...

Page 32: ... organization and or dealer The recycling of materials will help to conserve natural resources CAUTION By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product Battery notice The battery symbol on the products and or accompanying docume...

Page 33: ... 0 01 Hexavalent chromium 0 1 Lead 0 1 Mercury 0 1 Polybrominated biphenyls PBB 0 1 Polybrominated diphenyl ethers PBDE 0 1 At the date of preparation of this manual Medical Devices are exempted of the RoHS Directive However the manufacturer is committed to meet the requirements of the European RoHS Directive in case the exemption is cancelled If there is a RoHS label at the rear of the printer it...

Page 34: ...practice not to delete images from the modality until they are correctly printed WARNING It is advisable to do a reprint when film artifacts are present in the image In case of general image quality degradation please refer to the section on problem solving Related Links Quality Control on page 93 34 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 35: ...tion tasks can also be performed by the customer after a training course has been provided Contact your local support organization for more information For more information about the installation refer to the Plug Play installation manual and or the Mobile Kit installation manual Crystal Imager Introduction 35 3831B EN 20210601 1655 ...

Page 36: ...o country The user must make sure that training is received in accordance with local laws or regulations that have the force of law Your local dealer representative can provide further information on training The user must note the following information in the system documentation Intended Use Intended User Safety Directions 36 Crystal Imager Introduction 3831B EN 20210601 1655 ...

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

Page 38: ...part C IEC 60601 1 2 ETSI 300330 ETSI 301489 1 GB9254 1998 Class A GB17625 1 2003 EMC issues USA This equipment has been tested and found to comply with the limits for a class A digital device pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generate...

Page 39: ... 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 Seismic earthquake requirements The printer meets the CA Californian requirements Crystal Imager Introduction 39 3831B EN 20210601 1655 ...

Page 40: ...cessories The printer is also a native DICOM printer Therefore the standard DICOM protocol can be used as network protocol and again without any additional options or accessories the printer will be able to process and print the DICOM jobs Safety compliance Accessory equipment connected to any interfaces must be certified according to the respective IEC standards e g IEC 62368 for data processing ...

Page 41: ...neral radiography applications On the top right corner of each film a System info area will be printed This info can only be read using a magnifying glass The System info area contains info about The printer serial number densitometer info film counts software version etc Crystal Imager Introduction 41 3831B EN 20210601 1655 ...

Page 42: ... The controller image source date time etc For more detailed information refer to the Service documentation 42 Crystal Imager Introduction 3831B EN 20210601 1655 ...

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

Page 44: ... The user must define who can access patient data in which situations The user must have a strategy available on what to do with patient data in case of a disaster Topics Storage media Node authentication certificates and Certification Authority Requirements on the operating environment 44 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 45: ...atient 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 Crystal Imager Introduction 45 3831B EN 20210601 1655 ...

Page 46: ...owed table A Certification Authority CA is responsible for creating a certificate The CA can be the hospital the manufacturer or a third party This CA distributes the certificate to the hospital security responsible or service technician who for his part Imports the device certificate created by the CA Imports the certificates of all peer devices with which communication is authorized i e creates ...

Page 47: ...uthority from Agfa further distribution outside the company is not allowed Perimeter firewalls shall be in place and appropriately configured in order to ensure that communications between medical devices and external resources are either denied or restricted to just the communications that are essential for the medical devices to properly function Network Intrusion Detection Prevention Systems NI...

Page 48: ...ively A formal user provisioning and de provisioning process shall be implemented to enable the appropriate management of access rights to medical devices Users shall be assigned unique accounts to medical devices User access rights to medical devices shall be reviewed for appropriateness and corrected as needed at regular intervals not exceeding once a year 48 Crystal Imager Introduction 3831B EN...

Page 49: ...es operator mode Keyoperator mode service mode specialist mode and administrator mode Topics Control modes local and remote Operator mode Key operator mode Service mode Specialist mode Administrator mode Crystal Imager Introduction 49 3831B EN 20210601 1655 ...

Page 50: ...ected Operator mode No Operator mode Yes Key operator mode No Key operator mode Yes Service mode Yes Specialist mode Yes Administrator Yes Key operator mode is password protected when the default language is set to Russian The manual describes the controlling of the printer via the keypad When controlling the printer via a remote PC the menus are structured in the same way and sometimes they offer...

Page 51: ...l 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 Acces is possible via the local keypad and via a connected remote PC password protected Crystal Imager Introduction 51 3831B EN 20210601 1655 ...

Page 52: ...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 Acces is possible via the local keypad and via a connected remote PC password protected 52 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 53: ...ode The service mode functions are reserved for trained service personnel The service mode is password protected Acces is possible via a connected remote PC Crystal Imager Introduction 53 3831B EN 20210601 1655 ...

Page 54: ...ode 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 54 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 55: ...he 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 Crystal Imager Introduction 55 3831B EN 20210601 1655 ...

Page 56: ... button 2 Display 3 Keypad 4 Status indicator LED 5 Film input trays 6 Film output tray Figure 5 Overview of user interface controls WARNING Never try to open the printer during printing Always follow the instructions on the display Topics Messages The status indicator LED The control buttons Rear panel Audio signals The keypad 56 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 57: ... The display Crystal Imager Introduction 57 3831B EN 20210601 1655 ...

Page 58: ...us Action Red Blinking Warning status Check the display for messages Constant Error status The user must read these messages carefully It will provide information on what to do from then on This will be either performing an action to resolve the problem or to contact your local service organization Details on the contents of messages can be found in the service documentation which is available to ...

Page 59: ...tes the status of the printer Color Light Status Action Green Constant Ready stand by Proceed Blinking Busy or in Keyoperator mode Wait Red Blinking Warning status Check the display for mes sages Constant Error status Crystal Imager Introduction 59 3831B EN 20210601 1655 ...

Page 60: ...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 Related Links Switching off the printer on page 71 60 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 61: ... To connect to the hospital network 3 Power connector To connect the printer power cord Inserting a USB flash drive The printer is equipped with a USB port which is located at the rear side Note The USB flash drive must be formatted with the FAT32 file system An error will be displayed if a USB flash drive with a different file system is inserted Crystal Imager Introduction 61 3831B EN 20210601 16...

Page 62: ...eep means that printer has accepted the key command and is starting the operation A long beep means that you have pressed a non active key or that the printer has rejected the key command Note Certain conditions can cause an interval beep An interval beep accompanies an error or warning message 62 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 63: ...Key operator mode To select a menu To accept an entry in a menu Up key To move the cursor to the previous entry field To scroll upwards To increment the number in a n alpha nu merical entry field Down key To move the cursor to the next entry field To scroll downwards To decrement the number in a n alpha nu merical entry field Left key To scroll backwards through multiple choices within a field To ...

Page 64: ...alpha nu merical entry field from left to right To toggle between values in a field Note All keys except the Key operator key have an indicator that is on when the key is valid in a certain situation Note You can press and hold down an arrow key to scroll quickly through a list or a menu 64 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 65: ...neral display features The figure below shows how the display is illustrated in this manual 5 Restore config 6 Calibration 7 Service Actions 8 Quality Control 9 Installation Reachable with Up Down arrow keys Visible The visible display lines are indicated in the upper zone The other possible lines are shown in the lower zone and can be reached by scrolling using the Up Down arrow keys on the Keypa...

Page 66: ... be used to refer to the corresponding modality In case no nickname has been defined during installation the AE title will be used Related Links Managing the print queue on page 73 Key operator mode In Key operator mode operation is menu driven The menu displays the Keyoperator functions 5 Restore config 6 Calibration 7 Service Actions 8 Quality Control 9 Installation Reachable with Up Down arrow ...

Page 67: ...f one figure will also decrement the next figure to the left respecting the valid limits of the range Move the entry position in a n alpha numerical entry field from right to left by pressing the Left key Move the entry position in a n alpha numerical entry field from left to right by pressing the Right key Press and hold down a key to repeat arrow key actions To accept an entry in a menu press th...

Page 68: ...ely 9 minutes before the printer can start printing After approximately 6 minutes the READY message appears and from then on you can send print jobs to the printer but it will take another five minutes for the printer head to heat up When you send print jobs to the printer during this five minutes the printer will use that time to calculate the print job and the display will inform you that the pr...

Page 69: ...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 Loading films on page 83 Crystal Imager Introduction 69 3831B EN 20210601 1655 ...

Page 70: ...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 70 Crystal Imager Introduction 3831B EN 20210601 1655 ...

Page 71: ... be resumed next time the printer is switched on Press the Power Reset button to switch If the printer is printing it will finish that print job When the printer is ready it shuts down immediately Note After switch off the device is still in stand by mode To remove the device from the mains supply disconnect the mains plug Crystal Imager Introduction 71 3831B EN 20210601 1655 ...

Page 72: ...tion Task Description Pausing the print queue To pause the print queue The printer will finish the current print job but will not start the next print job Viewing the film count info To view the number of films left in the trays Viewing the printer status To view the current events Topics Managing the print queue Pausing the print queue Viewing the film count info Viewing the printer status Deleti...

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

Page 74: ...folder to be submitted as one print job Refer to the User manual of the acquisition modality for more information If jobs have been transmitted from the network to the printer they are put in the print queue on a first in first out schedule New jobs that are added to the queue get the waiting status As soon as the last film of a job is ejected in the output tray the next job that has been calculat...

Page 75: ...t info or to view the printer status A description of the possible status of the jobs is listed in the table below Status Description PR Printing Printing of this job is in progress CA Calculating The necessary calculations are already being made before printing of the job can be started WA Waiting Jobs are queued in the printer memory Note On the print queue screen the modality name defined durin...

Page 76: ...key to enter the operator menu The Operator menu screen appears 2 On the Operator menu press the Confirm key to select Pause print queue 3 If the printer is printing it will first finish its current print job 4 When the printer is ready the print queue is paused 5 To resume printing press the Confirm key 76 Crystal Imager Basic Operation operator mode 3831B EN 20210601 1655 ...

Page 77: ...info The following screen appears The progress bar indicates the evolutions of the film usage in an input tray The bar is divided into 10 parts each part represents approximately 10 of the total films of a film pack The last part of the bar will disappear when more than 80 of a film pack has been printed 3 Press the Confirm key to return to the print screen Note When a film job cannot be done beca...

Page 78: ...rator menu The Operator menu screen appears 2 Press the Down key twice followed by the Confirm key to select Printer status The following screen appears The screen informs you by means of short event descriptions about current events There is only one event per line An event could be e g a current film jams an empty tray 3 Press the Confirm key to return to the print screen 78 Crystal Imager Basic...

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

Page 80: ... print head TPH Note Avoid to mix trays between printers Incompatibilities in the tray mechanism may cause damage or failure to detect the tray The tray mechanism of printers with serial numbers starting with 10 or 70 are incompatible with the tray mechanism of printers with serial numbers starting with 15 or 75 Note The system performs an automatic calibration when the film format has been change...

Page 81: ...rovided with a screw 4 Remove the film position tab 1 1 2 2 1 To remove the width format tabs loosen the screw first and then pull out the tab 2 To remove the depth format tab slide it to the left to unlock it and then pull out the tab 5 Put the film format tab in place Crystal Imager Basic Operation operator mode 81 3831B EN 20210601 1655 ...

Page 82: ... the slots and tighten the screws 2 To position the depth format tab insert it in the slot and slide it to the right to lock it 6 Load a new film pack Related Links Loading films on page 83 82 Crystal Imager Basic Operation operator mode 3831B EN 20210601 1655 ...

Page 83: ...s In the examples below we will assume that the lower input tray is to be loaded Note The procedure is slightly different depending on the fact wether the printer is printing calculating or in the ready state WARNING Never load an additional film sheet or film sheets to a film pack in use Only load a new film pack when the current input tray is empty Related Links Changing the film format of the t...

Page 84: ...dure The following screen appears when the printer is still printing 2 Wait while the printer finishes printing any current jobs When the film path is cleared the following screen appears automatically 3 Open the lower input tray 4 Load a new film pack Related Links Loading films on page 83 84 Crystal Imager Basic Operation operator mode 3831B EN 20210601 1655 ...

Page 85: ... 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 Related Links Loading films on page 83 Crystal Imager Basic Operation operator mode 85 3831B EN 20210601 1655 ...

Page 86: ... receive a new film when the following message appears 3 Remove the white cover sheet 4 Take film pack and open it Note Verify that the film type on the film pack corresponds with the sticker on the tray If you do use an other film type you are advised to change the label on the tray 86 Crystal Imager Basic Operation operator mode 3831B EN 20210601 1655 ...

Page 87: ...u do this make sure that the table is dust free 5 Remove the sticker from the film pack 6 Remove the plastic film bag partially 7 Slide the film pack into the input tray and remove the plastic film bag completely Crystal Imager Basic Operation operator mode 87 3831B EN 20210601 1655 ...

Page 88: ...hen a film job cannot be done because the tray to which the job is assigned is empty then the printer will check if the films in the other tray can be used for this and other print jobs in the print queue The printer will skip the print jobs that cannot be done and will resume them later Note When a film sheet is inserted wrongly in the input tray then the printer will print on the back side non e...

Page 89: ...WARNING Never reuse a jammed film Crystal Imager Basic Operation operator mode 89 3831B EN 20210601 1655 ...

Page 90: ...t the right side of the input tray cover When closing the input tray the Film Identification tag is read and the printer settings are automatically adjusted The Film Identification tag is located on the protective sheet on the backside of the film pack The figure below shows the film pack upside down For some new film types the Film Identification tag will be covered by a sticker and therefore wil...

Page 91: ...rint images from a USB flash drive Save configuration To make a back up of the printer settings Restore configuration To restore the back up of the printer settings Calibration To calibrate the printer Service actions To view error and maintenance data Quality Control To perform the QC procedure Installation To install or update the printer software Note These functions are described in detail in ...

Page 92: ...ng messages Clean therm head Language Beep on empty tray General setting Service actions Quality Control Installation Printer installation Calibration Restore configuration Save configuration Change settings NETWORK only SMPTE Etc Show open and update Show closed items Show settings Print image General NETWORK only General Other Per modality setting Film type Film format Film view Lower Input tray...

Page 93: ... Copy quality procedures for each input tray loaded with general radiography films The results of these tests are recorded on Quality Control Charts 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 Related Links Establishing the reference values and verifying image quality on page 94 Performing quality control QC t...

Page 94: ...Artifact Levels and the Image Geometry values are all recorded on the Quality Control charts On these charts the following test conditions are also recorded The type and serial number of the printer The type and emulsion number of the film used to determine the reference values The type of densitometer used The time day month year that the values were established WARNING Before you can establish t...

Page 95: ...The location size and shape of the QC objects do not jeopardize the functionality of the QC and can be altered depending on software versions film types and film sizes QC test image for film format 14x17 Lo D Base Fog Max D Hi D Mid D Lo D Sets of dots visible Yes Base Fog DD Density Difference H i D L o D Weekly spatial Resolution test Daily density tests Geometry test Max D Hi D Mid D Identifica...

Page 96: ...ible Yes Base Fog DD Density Difference H i D L o D Weekly spatial Resolution test Daily density tests Geometry test Max D Hi D Mid D Identification Initials Date Time No 2 3 1 96 Crystal Imager Advanced Operation key operator mode 3831B EN 20210601 1655 ...

Page 97: ...or mode 2 Press the down key seven times followed by the confirm key to select Quality Control 5 Restore config 6 Calibration 7 Service Actions 8 Quality Control 9 Installation Reachable with Up Down arrow keys Visible A confirmation screen appears 3 Do one of the following Press the Confirm key YES to start the QC procedure and proceed with step 4 Press the Escape key NO to quit 4 Define the tray...

Page 98: ...eet or exceeds the recommended values the reason must be found and the problem solved before any further clinical films can be printed 7 Record the low mid and high density levels on Chart 1 Determination of Operating Levels 8 Press the Confirm key to return to the main menu 9 Repeat step 1 through 8 once a day for five consecutive days as indicated on Chart 1 10 Calculate the average value of the...

Page 99: ...rts will be used for the daily quality test Related Links Quality Control Charts on page 124 Preventive maintenance schedule on page 106 Performing the daily QC test on page 102 Crystal Imager Advanced Operation key operator mode 99 3831B EN 20210601 1655 ...

Page 100: ...dge of the right line and distance B from the upper edge of the upper line to the lower edge of the lower line We strongly recommend using a 30 cm 12 inch machinist scale with 0 5 mm divisions 1 64 inch 3 Record these values as reference dimensions Aref and Bref on Chart 4 Geometric Consistency Control Chart These charts will be used for the annual quality test 4 Save this film for future referenc...

Page 101: ...e circles Within each circle there are three groups each consisting of five dots All five dots of each group must be visible with a magnifying glass The smallest cluster of 5 dots is only visible if the viewing conditions are good 4 Check the Low Contrast Visibility at both the high 100 95 and low end 0 5 of the density scale You should be able to see the circle in the square and the upper circle ...

Page 102: ...daily QC test Performing the weekly QC tests Performing the annual QC tests Performing the daily QC test WARNING This test must be performed every day before any clinical film can be processed 1 Turn on the printer and wait at least for 15 minutes 2 Press the Key operator key to enter the Key operator mode 3 Press the down key seven times followed by the ok key to select QC 5 Restore config 6 Cali...

Page 103: ...or the unacceptable density variations must be identified and resolved before any further clinical films can be processed This may include repeating the film calibration procedure Related Links Switching on the printer on page 68 Quality Control Charts on page 124 Performing the weekly QC tests Spatial Resolution Artifact Test and Low Contrast Visibility To identify artifacts and verify spatial re...

Page 104: ...NG In case of significant artifacts insufficient spatial resolution or failure of any other recommended QC tests the cause of the problem must be identified and corrective action must be taken before the printer can be used for any further clinical imaging Related Links Performing the daily QC test on page 102 QC test image on page 95 Performing the annual QC tests Geometric Consistency Test To be...

Page 105: ...Bref should be less than or equal to 1 0 5 Check for image distortion 6 Calculate the aspect ratio by dividing A by B The result must be 1 0 01 WARNING If the image size or distortion values are outside of limits contact your local service organization to resolve the problem Related Links Establishing the image geometry reference values on page 100 Crystal Imager Advanced Operation key operator mo...

Page 106: ...tion When image quality tends to degrade An appro priate warning message is displayed Cleaning the print head Print head cleaning must be done when image quality problems occur Always consult your local service representative for complete maintenance schedules Topics Safety guidelines Recurrent safety tests Cleaning and disinfection Cleaning the print head Calibrating the touchscreen 106 Crystal I...

Page 107: ...efore carrying out any maintenance work inside the printer Note Film jam removal or cleaning the printer head can be done without switching the power off Related Links Safety precautions on page 25 Recurrent safety tests The printer shall be tested according to IEC 62353 in a time interval of at least 36 months or less if local regulations are different Medical electrical equipment Recurrent test ...

Page 108: ...er 1 Switch off the printer 2 Remove the power plug from the socket 3 Wipe the exterior of the printer with a clean soft damp cloth Use a mild soap or detergent if required but never use an ammonia based cleaner WARNING Make sure no liquid gets in the printer Note Do not open the printer for cleaning No components inside the printer require cleaning by the user 4 Plug in the printer and switch it ...

Page 109: ...ig 6 Calibration 7 Service Actions 8 Quality Control 9 Installation Reachable with Up Down arrow keys Visible 3 On the Select calibration menu press the Down key followed by the Confirm key to select Clean therm head 4 The Thermal head cleaning screen will give step by step instructions on what to do 5 Open the top cover 6 As soon as the top cover is opened the Thermal head cleaning screen continu...

Page 110: ...old 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 110 Crystal Imager Preventive maintenance schedule 3831B EN 20210601 1655 ...

Page 111: ... because this pressure may cause damage on the interconnections underneath the print head 11 Close the print head unit the hold down bracket and finally the top cover After you have cleaned the print head resistor line and you have closed the top cover you will return automatically to the Select calibration menu see step 3 Note If residue dust is present as part of the cleaning procedure it will d...

Page 112: ...eep the touchscreen accurate 1 Press and hold the text display of the touchscreen for 7 seconds Figure 6 Text display The first calibration screen is displayed Figure 7 Calibration screen 2 Press the indicated point on the touchscreen as precise as possible The second calibration screen is displayed 112 Crystal Imager Preventive maintenance schedule 3831B EN 20210601 1655 ...

Page 113: ...ossible The third calibration screen is displayed Figure 9 Calibration screen 4 Press the indicated point on the touchscreen as precise as possible The final calibration screen is displayed Figure 10 Calibration screen Crystal Imager Preventive maintenance schedule 113 3831B EN 20210601 1655 ...

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

Page 115: ...radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment Harmonic emis sion in accord ance with IEC 61000 3 2 Class A Voltage fluctua tions flickering in accordance with IEC 61000 3 3 Fulfilled The device is used in a professional healthcare radiological environment Environmental conditions are stated in the user manual...

Page 116: ... typical com mercial or clini cal environment Voltage break throughs short term interrup tions and varia tions in the volt age supplied in accordance with IEC 61000 4 11 0 Ur for peri od 0 Ur for 1 peri od 70 Ur 30 breakthrough of Ur for 25 peri ods 0 Ur for 250 pe riods 0 Ur for period 0 Ur for 1 periods 70 Ur 30 break through of Ur for 25 periods 0 Ur for 250 periods The quality of the voltage s...

Page 117: ...and mo bile radio sets at a safe distance from the device including the leads not closer than the recommended protective distance which is calculated according to the equa tion suitable for the RF emission frequen cy Recommended pro tective distance Conducted high frequency disturbance variables in ac cordance with IEC 61000 4 6 6 V m in ISM fre quency bands be tween 150 kHz and 80 MHz 6 V m in IS...

Page 118: ...s and people a The field strength of stationary transmitters such as base stations of radio telephones mobile broadcasts for rural areas amateur stations and AM and FM radio transmitters cannot be precisely predetermined theoretically An investigation of the location is recommended to ascertain the electromagnetic environment as a result of stationary high frequency transmitters If the field stren...

Page 119: ...73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 The distance can be determined through the equation for each respective column P is the rated power of the transmitter in watts W according to the manu facturer information on the transmitter only for transmitters where the rat ed power is not mentioned in the above table REMARK 1 An additional factor of 10 3 has been used to calculate the recommended p...

Page 120: ... Cables transducers and accessories 120 Crystal Imager Remarks for HF emission and immunity 3831B EN 20210601 1655 ...

Page 121: ...0 0 3 28 704 787 LTE Band 13 17 0 3 9 800 960 GSM 800 900 TETRA 800 IDEN 820 COMA 850 LTE Band 5 0 3 28 1700 1990 GSM 1800 COMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS 0 3 28 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 0 3 28 5100 5800 WLAN 802 11 a n 0 3 9 Crystal Imager Remarks for HF emission and immunity 121 3831B EN 20210601 1655 ...

Page 122: ...er of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation CAUTION Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the system including cables specified by the manufacturer Otherwi...

Page 123: ...aution Using cables and accessories not mentioned in this manual or spare parts not ordered from Agfa may cause a higher emission of electromagnetic phenomena and or may rise the susceptibility against it function type maximum length remark network connection CAT5 10 m shielded Crystal Imager Remarks for HF emission and immunity 123 3831B EN 20210601 1655 ...

Page 124: ...ce Mid Density level High Density Average of 5 Values calculated reference Hi g h D e nsi ty l e v el Step 1 Print QC Test images on five consecutive days Record the optical densities measurements in the tables below After five days average the values to determine the reference levels for each of the parameters Step 2 Copy the calculated reference levels to Charts 2A B Daily Density Control Chart ...

Page 125: ...sity Mid Density Upper Control limit 0 05 Calculated Reference Low Density Level Lower Control Limit 0 05 Upper Control limit 0 15 Calculated Reference Mid Density Level Lower Control Limit 0 15 General radiography applications Input Tray ________ Quality Control for Chart 2A Figure 12 Chart 2A Daily Density Control Chart Crystal Imager Quality Control Charts 125 3831B EN 20210601 1655 ...

Page 126: ...nal _____________ default selection High Density Upper Control limit 0 20 Lower Control Limit 0 20 Calculated Reference High Density Level General radiography applications Input Tray ________ Quality Control for Chart 2B Figure 13 Chart 2B Daily Density Control Chart 126 Crystal Imager Quality Control Charts 3831B EN 20210601 1655 ...

Page 127: ...lity of all Dots Month Day Artifacts Visibility of all Dots Month Day Artifacts Visibility of all Dots Month Day Artifacts Visibility of all Dots Low Contrast Visibility Low Contrast Visibility Low Contrast Visibility Low Contrast Visibility Low Contrast Visibility General radiography applications Input Tray ____________ Quality Control for Chart 3 Figure 14 Chart 3 Artifacts and Spatial Resolutio...

Page 128: ...ect Ratio Aref A A Aref A B Bref B B Bref Reference Dimensions Date Measured Dimensions Date Consistency Aspect Ratio Aref A A Aref A B Bref B B Bref General radiography applications Input Tray _______________________ Quality Control for Chart 4 Figure 15 Chart 4 Geometric Consistency Control Chart 128 Crystal Imager Quality Control Charts 3831B EN 20210601 1655 ...

Page 129: ...ed use may result in hazards which in turn may lead to serious injuries or fatal accidents for example electric shock AGFA positively will not assume any liability in these cases Note The device must only be installed and put into operation under the specified conditions For more information about safety security and use refer to the Reference and User manual Topics Contents of the packages Remove...

Page 130: ...etwork cable 3 Printer 4 Set of documents 5 User documentation Figure 16 Contents of the packages 1 2 3 1 Crosshead screwdriver 2 Flathead screwdriver 3 Wire cutter Figure 17 Required tools not included 130 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 131: ...ontaining country specific accessories 4 Remove 5 foam blocks at left and right side 3 Remove cardboard box 2 Remove the packing materials 1 Remove accessories box 3 Remove cardboard box 5 Remove plastic bag 2 Remove box containing country specific accessories 4 Remove 5 foam blocks at left and right side A Unpacking 4 Remove 5 foam blocks at left and right side e packing materials ox x 2 Remove b...

Page 132: ...4 18 2832E EN 20151008 5 Remove plastic bag 132 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 133: ...1 Lift printer from pallet with 3 persons 3 Put printer on a table Always put tray side at front 2 If only 2 persons are available lift as shown below 2 If only 2 persons are available lift as shown below 2 If only 2 persons are available lift as shown below Crystal Imager Plug Play Installation Manual 133 3831B EN 20210601 1655 ...

Page 134: ...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 134 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 135: ...XX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX XXXXXX XXXX XXXXXX Note Refer to the Packing slip for a complete list of accessories 2 Return the packing material Wood Paper Plastic Metals Crystal Imager Plug Play Installation Manual 135 3831B EN 20210601 1655 ...

Page 136: ...densing Power requirements The AC outlet must have either of following specifications 100 120 V 50 60 Hz 16 15 A 200 240 V 50 60 Hz 16 15 A Network requirements Ethernet connectors RJ45 twisted pair for 10 100 1000 Base TX Network protocols TCP IP services HTTP Space requirements 1 2 1 Space required for servicing and installation 2 Space required for normal use 136 Crystal Imager Plug Play Instal...

Page 137: ...ransport 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 Crystal Imager Plug Play Installation Manual 137 3831B EN 20210601 1655 ...

Page 138: ...5 Cut 3 red straps 6 Open hold down bracket 7 Open print head 8 Remove foam sheet 138 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 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 Crystal Imager Plug Play Installation Manual 139 3831B EN 20210601 1655 ...

Page 140: ... Remove orange screw The belt tightens itself 14 Reinstall side cover Slide bottom into slots 15 Tighten 3 screws 16 Close top cover 140 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 141: ...Crystal Imager Plug Play Installation Manual 141 3831B EN 20210601 1655 ...

Page 142: ...ar the printer and that it is easily accessible 1 Select power cable country specific order separately 10 Connect the cables 1 of 2 2 Locate the mains connector 4 Mount the strain relief 6 Move the printer to its final destination and lock the wheel 1 Select power cable country specific order separately 3 Connect the power cable 5 Locate the network connector and connect the network cable 2 Connec...

Page 143: ...ration 1 Verify that position tabs of upper tray are configurated for 14x17 films Possible film size settings 2 Verify that position tabs of lower tray are configurated for 8x10 films 3 To change configuration remove film position tab Crystal Imager Plug Play Installation Manual 143 3831B EN 20210601 1655 ...

Page 144: ...en the screws of the width format tabs 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 144 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 145: ... Take film pack and remove sticker 3 Remove plastic film bag partially 4 Slide film pack into tray and remove plastic film bag completely 5 Pull plastic tape from around films Crystal Imager Plug Play Installation Manual 145 3831B EN 20210601 1655 ...

Page 146: ...6 Close upper lower input tray 7 Stick film ID label to tray handle 146 Crystal Imager Plug Play Installation Manual 3831B EN 20210601 1655 ...

Page 147: ...creen 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 2 Wait until READY Crystal Imager Plug Play Installation Manual 147 3831B EN 20210601 1655 ...

Page 148: ...wizard a Press the Key operator key b In the Key operator main menu select Installation c In the Installation menu select Printer install wizard d Follow the instructions see Reference manual 2 Select and initiate printer calibration a Press the Key operator key b In the Key operator main menu select calibration c In the Select Calibration menu select Film d Follow the instructions see Reference m...

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