User Manual - Spectrum Medical X
Contents
1. 9 Switch on the digitizer Note After removing a jammed image plate erase the image plate before the next exposure 2491A EN 2012 04 06 Operating CR 10 X 53 CR 10 X Behavior in Case of Power Failure Note The description below is only applicable if an uninterruptible power supply UPS is put into the CR system configuration In case of a power failure the system is still connected to the UPS Two situations are possible e Power failure after cassette insertion and before identification with the NX workstation The digitizer pushes the image plate back in the cassette without scanning and releases the cassette After the power supply returns the cassette must be inserted into the digitizer and identified again to read out the image e Power failure after identification with the NX workstation The image plate is scanned and erased as usual The scan cycle finishes when the cassette is released If the power supply is still not available the digitizer will refuse scanning other cassettes 34 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X Cleaning the Optical Unit The only maintenance action which you must perform is checking the image quality Refer to the User Manual of the NX software Cleaning the optic unit is required if stripes parallel to the image plate movement can be seen in the image When you recognize this type of artefact when using the digitizer clean the optic unit2. AGFA CR Plates and Cassettes CR MD1 0 General User Manual document 2492 CR Full Leg Full Spine User Manual document 4408 available on NX User Doc umentation CD The Getting Started material contains Getting Started with NX document 4417 I Getting started with CR 10 X document 2493 4 Introduction 2491A EN 2012 04 06 CR 10 X Training The user must have received adequate Agfa training on the safe and effective use of the product before attempting to work with it Training requirements may vary from country to country The user should ensure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa representative can provide further information on training The user must note the following information in the preliminary section of this manual E Intended Use E Intended User M Safety Directions Product Complaints Any health care professional for example a customer or a user who has any complaints or has experienced any dissatisfaction in the quality durability reliability safety effectiveness or performance of this product must notify Agfa If the device malfunctions and may have caused or contributed to a serious injury of a patient Agfa must be notified immediately by telephone fax or written correspondence to the following address Agfa Service Support local support addresses and phone numbers listed on www agfa com Agfa H
3. As is the case for all technical devices the digitizer must be operated cared for and serviced correctly A regular quality control is recommended If you do not operate the digitizer correctly or if you do not have it serviced correctly Agfa is not liable for resulting disturbances damages or injuries If you notice conspicuous noise or smoke disconnect the digitizer immediately Do not pour water or any other liquid over the device Perform no other operations on the digitizer than those described in this document Switch the system off before moving it When reaching the new position switch the system on again Do not transport the digitizer without packaging or without mounting it in a mobile kit 2491A EN 2012 04 06 Introduction Quality Control Apply regular quality control according local regulations 0 Introduction 2491A EN 2012 04 06 Starting the Digitizer Basic Workflow Stopping the Device CR 10 X Starting the Digitizer 1 Make sure the digitizer is connected to the control PC and that the control PC is running the appropriate NX software For more information refer to the NX User Manual 2 Press the power button Power button The machine starts the following operation sequence e initialization of all components e functional test of all components e check for presence of cassettes and or IPs e establish connection to the control PC During the self
4. Dedicated configuration To install the UPS into the system 1 Plug the UPS power cord into the input connector at the UPS rear panel 2 Plug the other side of the UPS power cord into a power outlet 3 Plug the digitizer NX workstation and monitor into the appropriate UPS output receptacles In case of power failure the batteries of the UPS supply power to the digitizer the NX workstation and monitor 10 Introduction 2491A EN 2012 04 06 CR 10 X Full Leg Full Spine Application Components e CR Full Body Cassette Holder e Anti scatter grid optional e CR EasyLift optional For more information and instructions on the FLFS application refer to the document 4408 CR Full Leg Full Spine User Manual 11 2491A EN 2012 04 06 Introduction CR 10 X Operation Controls The digitizer interfaces with the user via e a power button e an erase button e astatus indicator e acassette release button 4 Power button 2 Erase button 3 Status indicator 4 Cassette release button 12 Introduction 2491A EN 2012 04 06 CR 10 X The Erase Button Press the erase button to start the erasing cycle of an image plate After pressing the erase button the status indicator is continuously lighting up in blue and the digitizer starts erasing the image plate of the cassette inserted next If no cassette with image plate has been inserted after 60 seconds the system automat
5. 1 Check that the system is ready for operation The status indicator on the digitizer constantly lights up in green 2 Click on Read and Initialize Cassette in the Functionality Overview pane of the Main Menu window of the NX station The Read and Initialize Cassette pane is opened in the middle section of the Main Menu window Le Image Overview l Monitoring amp Management Import Export n selected Please Full Leg Full Spine Hel p For more information refer to the NX Key User Manual document 4421 2491A EN 2012 04 06 Operating CR 10 X 43 CR 10 X 3 Click on the Read button at the NX workstation The digitizer waits for the cassette and the status indicator constantly lights up in green 4 Insert the cassette containing the image plate into the cassette slot of the digitizer as shown below Make sure to insert the cassette with the black side to the top and with the shutter opening mechanism and the locking mechanism inside the digitizer Make sure that the cassette is firmly pushed into the slot Otherwise the digitizer cannot read the image plate Once the cassette is locked the status indicator on the digitizer is blinking green The digitizer starts reading the initialization data 5 When the digitizer has finished reading the initialization data the status indicator constantly lights up in green and the cassette can be unlocked 6 Push the Cassette relea
6. Hanne Troonbeeckx 5938834 Jill Peeters M3071 Mr De Jos JO3171 Muhammad EI AL M3070 Paulie Chan CHI45764 Peter Selie S789654 Serge Moambe K4567 Tony Soprano MOB4568 e Chris Tus M3070 John Doe Closed Exams 4 Manual Worklist 0 Emergency Exam 4 5 1981 Female 5 11 2003 Female 9 11 1922 Male 9 11 1911 Male 9 11 1945 Male 11 12 2002 Male Male 9 11 1922 Male 12 25 1950 Male M Accession Number HO1889 MOL2003 TMF 2555 PD7555 PI75558 GRO38 ERROO1 JC6262 Abvdi2 Image Overview 0 1 SPS Description Trauma Foot sv Pelvis Abdomen Ribbs Ankle Humerus humerus with contrast Shoulder Transfer Images Start Exam e To open a patient from the RIS select an Exam from the list 1 and click on Start Exam 2 e To enter patient data manually click New Exam 3 and enter patient data and image data manually For more information refer to the NX User Manual document 4420 Getting Started with the CR 10 X 2491A EN 2012 04 06 CR 10 X Step 2 Digitize the image At the digitizer 1 Check that the digitizer is ready for operation The status indicator on the digitizer constantly lights up in green 2 Insert the cassette containing the exposed image plate into the cassette slot of the digitizer Make sure to insert the cassette with the black side X ray tube side to the top and with the shutter opening mechanism and the
7. 04 06 Reading an Emergency Image Plate Re erasing an Image Plate Reading the Initialization Data of an Image Plate Expiry of Image Plates Troubleshooting CR 10 X Reading an Emergency Image Plate Note Reading an emergency image plate is a licensed functionality necessary to facilitate the emergency cases and to improve the workflow In emergency situations it is possible to open an emergency exam at the NX workstation without patient details and to digitize the image plate without having identified the cassette For detailed information about the emergency license refer to the NX manuals 40 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X Re erasing an Image Plate At the end of a normal or emergency digitizing cycle the digitizer returns an erased image plate However in the following cases you must re erase the image plate before re using it in order to prevent ghost images from interfering with the image of interest e Ifthe image plate has not been used for more than 48 hours e If an image plate has been exposed to an exceptionally high X ray dose In this case deep layers of the image plate may still retain a latent image after standard erasure Leave the image plate to rest at least one day before re erasing it Note To re erase an image plate you must push the Erase button at the front side before you insert the cassette After that you have 1 minute to enter a cassette If you do
8. HealthCare N V All rights reserved Published by Agfa HealthCare N V B 2640 Mortsel Belgium No part of this document may be reproduced copied adapted or transmitted in any form or by any means without the written permission of Agfa HealthCare N V Date of the latest revision of the user manual 2012 04 06 2491A EN 2012 04 06 CR 10 X Table of Contents Chapter 1 Mirodut a o scrnsseseseiaasesseaciaans eas ERE EE 5 Introduction to this Manual ssssessscsssrssrsdasrinsrsissrdrisin snssosu nd kirasi ninanais 6 E A A A A EAE ieee 6 Warnings Cautions Instructions and Nate cccsisssccesnisssacivniodineminrncesesaiacssiasaiens 6 E E e EAA A A 7 TAC io OCR TIO scissile InE 8 menoa UE era 9 ea E a E AT 9 on E E ee pie en eee 10 O E enced cicteeaiess cca te pd a aetna 12 reales Cal O te 100 lt 1 Ve atO GeO Dne Deen Rey eae nes Pim ei ere terrace veneer steerer enon err renee 14 A 5 gen reaper ecient a einen ee 15 Be acicaceisccedevsitegndaetsentese nea etteatnnetssisiaetenancaseasnncnntiaewsenaieet 15 COn oreo E EEE eames 16 SE AE E E 17 CE E E EEE O eee 19 D E 19 E E PPA PE ARE ARA EA AEEA tee eee 21 Clea and Digi ie E 24 BR ee iE 25 Jo FUEL A ETE E APII eee ea ene ee Sea nee TEAT ee er Werner ence yen romney Te 26 alaale ae Beefs 11 2 i PERPE PATEE ERO A AAN A A AT a7 eN D E E a 28 Canty COMTO Dorpe o ease 30 Chapter 2 Getting Started with the CR 10 X esssesssesseesseesseess 31 arhe thie EO eins p nacicsn t
9. Includes Corrigendum 1 2011 CAN CSA C22 2 NO 60601 1 08 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Adopted IEC 60601 1 2005 third edition 2005 12 CR 10 X Laser Products e IEC 60825 1 1993 Safety of laser products Part 1 Equipment classification requirements and user s guide corr February 1995 amendment A1 1997 amendment A2 2001 Electromagnetic Compatibility e IEC 60601 1 2 2007 Medical electrical equipment part1 2 General requirements for safety collateral standard electromagnetic compatibility requirements and tests e FCC part 15 USA e CSA 22 2 No 601 1 2 Canada Waste e WEEE 2002 96 EC amended by Directive 2003 108 EC e ROHS Directive 2002 95 EC Labeling e EN 980 2008 Symbols for use in the labeling of medical devices e EN 1041 1998 Information supplied by the manufacturer with medical devices Note The CR 10 X is in compliance with the EG regulation 93 42 EEC Directive Medical Device Radio Interference Suppression It is hereby certified that the digitizer has interference suppression according to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A WARNING 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 oper
10. MHz 800 MHz to 2 5 GHz 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 manufacturer information on the transmitter only for transmitters where the rated power is not mentioned in the above table e REMARK 1 An additional factor of 10 3 has been used to calculate the recommended protective distance of transmitters in the frequency range from 80 MHz to 2 5 GHz to reduce the probability that mobile portable communication equipment unintentionally brought into the area of the patients will lead to a disruption REMARK 2 These Guidelines may not be relevant in all situations The dispersion of electromagnetic waves is influenced by absorption and reflections from buildings objects and people 66 2491A EN 2012 04 06 CR 10 X 2491A EN 2012 04 06 67 CE 0413 Printed in Belgium Published by Agfa HealthCare N V B 2640 Mortsel Belgium AG FA L 2491A EN 2012 04 06 HealthCare
11. implemented into national law by the individual European countries by August 13 2005 T The directive on Waste Electrical and Electronic Equipment WEEE Due to the implementation into national law specific requirements can be different within the European Member States This symbol on the products and or accompanying documents means that used electrical and electronic products should not be treated as or mixed with general household waste For more detailed information about take back and recycling of this product please contact your local Agfa service organization and or Agfa dealer 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 The recycling of materials will help to conserve natural resources Battery Notice This wheeled bin symbol on the products and or accompanying p documents means that the used batteries should not be treated as or 3 mixed with general household waste This wheeled bin symbol on batteries or its packaging may be used in combination with a chemical symbol In cases where a chemical symbol is available it indicates the presence of respective chemical substances If your equipment or replaced spare parts contain batteries or accumulators please dispose of them separately according to local regulations For battery replacements please
12. part of the conformity assessment procedures required by 93 42 EEC MDD European Council Directive 93 42 EEC on Medical Devices The digitizer has been designed in accordance with the IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety The digitizer complies with the safety regulations for Quality Management ISO 13485 2003 Cor 1 2009 Medical devices Quality management systems requirements for regulatory purposes IEC 62366 Medical devices application of usability engineering to medical devices first edition October 2007 IEC 62304 Medical Software Life Cycle Processes Medical Electrical Equipment 2491A EN 2012 04 06 Introduction 17 IEC 60601 1 second edition 1988 12 Medical electrical equipment General requirements for safety incl amendment 1 1991 11 and amendment 2 1995 03 IEC 601 1 1 1992 A1 1995 EN 60601 1 1 1993 A1 1996 Medical electrical equipment Part 1 General requirements for safety 1 Collateral standard Safety requirements for medical electrical systems IEC EN 60601 1 4 1996 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems inclusive amendment 1 1999 IEC 60601 1 third edition 2005 12 Medical electrical equipment General requirements for safety UL60601 1 2005 Medical electrical equipment General requirements for safety Adopted IEC 60601 1 2005 third edition 2005 12
13. test which may take up to 3 minutes the digitizer status indicator is blinking red Note During the self test you cannot activate any functions If the digitizer has completed the self test successfully the digitizer enters the operator mode and the status indicator is continuously lighting up in green 32 Getting Started with the CR 10 X 2491A EN 2012 04 06 CR 10 X Basic Workflow The main functions of the system are digitizing image plates and transmitting the digital image data to the image processing station where you can perform an image quality control The workflow consists of the following successive steps Step 1 Select a patient and start the exam Step 2 Digitize the image Step 3 Perform a quality control Step 4 Remove the cassette and insert the next one Step 1 Select a patient and start the exam At the NX workstation Open the Worklist window of NX In the Worklist window you can view and manage the exams that are scheduled via the Worklist pane Note When starting the NX software the Worklist window is the first win dow that appears after the NX splash screen Note Start the NX software on the NX station Refer to the NX User Manual document 4420 33 2491A EN 2012 04 06 Getting Started with the CR 10 X CR 10 X 2 Inthe Worklist window open a patient from the RIS or enter patient data manually Worklist Search o Worklist 32 Patient Name
14. using the cleaning brush To clean the optic unit proceed as follows 1 Remove the cassette unit 2491A EN 2012 04 06 Operating CR 10 X 39 CR 10 X 2 Move the cleaning lever from left to right and back 3 Place back the cassette unit Note that the protruding elements of the cassette unit should be positioned correctly in line with the digitizer if the cassette unit is positioned too high the protruding elements on the cassette unit may become damaged 56 Operating CR 10 X 2491A EN 2012 04 06 Specifications CR 10 X Specifications Labelling 93 42 EEC Medical Devices Europe EN 60601 1 c ETL us ETL us certified UL 60601 1 North America c ETL us c ETL certified CSA 22 2 No 601 1 Unpacked approximately 30 kg 66 1b CE Electrical connection of CR 10 X Operating voltage 24 Vdc Electrical connection of external power supply Autoranging power supply from 100 V to 240 V ac 10 Class I with protection earth Operating voltage Connect to earthed supply circuitry only Mains frequency 50 60 Hz f Europe min 10 A max 16 A Mains fuse protection USA amp Japan min 10 A max 15 A Network connectivity EEEO RJ45 female 10 100 Mbit s autosensing shielding CAT5 Equi
15. CR 10 X type 5151 100 User Manual 2491A EN 2012 04 06 AGFA L HealthCare CR 10 X CE 0413 Manufacturer Agfa HealthCare NV Septestraat 27 B 2640 Mortsel Belgium For more information on Agfa products and Agfa HealthCare products please visit www agfa com Agfa and the Agfa rhombus are trademarks of Agfa Gevaert N V Belgium or its affiliates CR 10 X NX ADC QS and ADC VIPS are trademarks of Agfa HealthCare N V 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 Agfa HealthCare N V makes no warranties or representation expressed or implied with respect to the accu racy completeness or usefulness of the information contained in this document and specifically disclaims war ranties of suitability for any particular purpose Products and services may not be available for your local area Please contact your local sales representative for availability information Agfa HealthCare N V diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa HealthCare N V shall under no circumstances be liable for any damage arising from the use or inability to use any information apparatus method or process disclosed in this document Agfa HealthCare N V reserves the right to make changes to this document without prior notice Copyright 2012 Agfa
16. Ifthe image plate is in the digitizer and visible from the front side 1 Put the cassette unit with the cassette on a table 2 Gently remove the image plate from the digitizer 3 Slide the image plate completely into the cassette 4 Push the release button to detach the cassette from the cassette unit 1 2491A EN 2012 04 06 Operating CR 10 X gt CR 10 X Ifthe image plate is in the digitizer but not visible from the front side 1 Put the cassette unit with the cassette on a table 2 Open the back of the device by turning the four fixation rings by 90 degrees ap Gently remove the image plate from the back of the digitizer Slide the image plate completely into the cassette Close the back of the device nN UW A O Push the release button to detach the cassette from the cassette unit Note Never use force to clear the jammed image plate If it is not possible to gently remove the image plate call your local service organization Note Make sure not to bend the image plate when removing it from the device Note After a jam the image plate can be used again if it is not damaged 32 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X 8 Place back the cassette unit Note that the protruding elements of the cassette unit should be positioned correctly in line with the digitizer if the cassette unit is positioned too high the protruding elements on the cassette unit may become damaged
17. This device is intended for use Voltage fluctuations flicker by healthcare professionals only This emissions in accordance with Complies device may cause radio interference or may IEC 61000 3 3 disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the digitizer or shielding the location 2491A EN 2012 04 06 CR 10 X 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 Resistance to IEC 60601 Level of Electromagnetic Jamming Test Test Level Agreement Environment Guidelines Discharge of static electricity in accordance with IEC 61000 4 2 Fast transient electrical disturbance variables bursts in accordance with IEC 61000 4 4 Impulse voltages surges in accordance with IEC 61000 4 5 Voltage breakthroughs short term interruptions and variations in the voltage supplied in accordance with IEC 61000 4 11 Magnetic field at the supply frequency 50 60 Hz in accordance with IEC 61000 4 8 6 kV contact discharge 8kVair discharge 2 kV for network leads 1 kV for entry and outlet leads 1 kV push pull voltage 2 kV common mode voltage e lt 5 U gt 95 breakthrough of U for 1 2 period 40 U gt 60 breakthrough of U for 5 periods 70 U 30 breakthrough of U for 25 period
18. ated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense Introduction 2491A EN 2012 04 06 CR 10 X Connectivity The digitizer is connected to the workstation via Ethernet connection and uses the DICOM protocol to communicate with the workstation Installation Caution When installing the digitizer care must be taken to ensure that there is either a mains plug or an all cable disconnecting device in the internal installation fitted near the digitizer and that it is easily accessible The digitizer is equipped with handles at the bottom left and right sides to move the device easily to another location For two persons to lift the digitizer each should stand at the side of the digitizer and hold it by the handle with both hands For one person to lift the digitizer remove the cassette unit to reduce the weight stand in front of the digitizer and hold it by the handles Caution Do not lift the device by holding the cassette unit or by holding the back cover Caution The digitizer and the cassette storage shall be protected against direct radia
19. ation and the digitizer have to be connected to an uninterruptible power supply UPS or an institutional standby generator 28 Introduction 2491A EN 2012 04 06 CR 10 X General safety instructions Make sure that the digitizer is constantly monitored in order to avoid inappropriate handling especially by children Only trained service personnel must make repairs Only authorized service personnel must make changes to the digitizer If there is any visible damage to the machine casing do not start nor use the digitizer Do not override or disconnect the integrated safety features Do not apply excessive force when inserting a cassette into the digitizer Do not push the release button during scanning status indicator is blinking green or during erasure status indicator blue Do not insert a cassette when the digitizer is switched off Do not apply excessive shock or vibration to the digitizer during operation e g putting cassettes on top of the device This may decrease the image quality Neither should the device be moved during operation Do not allow the digitizer to be subject to excessive vibration during operation due to unstable ground e g vibration of nearby equipment or footsteps Switch off the device before performing any maintenance work or repairs Disconnect the digitizer from the mains before making repairs or performing any maintenance activities during which live electrical components may be exposed
20. ch is available to Agfa service personnel 46 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X Error Viewer Error Viewer is an application running on the NX PC To verify if Error Viewer is running check if the Error Viewer icon is present in the Windows taskbar To start the Error Viewer go to the Windows Start menu gt Startup and click ErrorViewer The Error Viewer dialog contains information about the status of the digitizer ve Error Viewer 192 192 192 192 ri Ea 1 Image plate detected during selftest inthe digitizer The image plate was moved back into the cassette 2 Please check whether the image is present at the workstation and re scan the cassette if necessary If the image is present the cassette was possibly not erased Erase the cassette again in any case j Friday February 24 2012 2 52 56 PM 4 Digitizer IP address example Scroll bar to show complete message Date and time of error Confirm button Ea Error code 47 2491A EN 2012 04 06 Operating CR 10 X CR 10 X Connection Problems In case the status indicator of the digitizer is blinking red the user should look at the status of the Error Viewer to decide whether digitizer internal problems or connection problems occurred If an error message is displayed on the NX PC the user is informed which actions to perform to solve the problem In case no error message is displayed on the screen a connection p
21. classification class IIIb wavelength 640 670 nm The laser beam divergence is 120 350 mrad The laser beam s deflection frequency is 70 1 s up to 90 1 s Under normal operating conditions device with all covers there can be no laser radiation outside the digitizer The technical concept does not allow the user to remove the top cover The cassette unit and the back cover can be removed e g to solve cassette or image plate jams The digitizer must be switched off before removing the cassette unit or opening the back of the device WARNING User interventions other than those described in this manual can be hazardous with regard to laser radiation 2491A EN 2012 04 06 Introduction 23 CR 10 X 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 Details about cleaning can be found in the following pages To clean the exterior of the digitizer 1 Switch off the digitizer 2 Remove the power plug from the socket Switch off the UPS if installed 3 Wipe the exterior of the digitizer with a clean soft damp cloth Use a mild soap or detergent if required but never use ammonia based cleaner Caution Make sure no liquid gets in the digitizer Note Do not open the digitizer for cleaning No co
22. contact your local sales organization 2491A EN 2012 04 06 Introduction CR 10 X Safety Directions WARNING The user must strictly observe all warnings cautions notes and safety markings within this document and on the product WARNING Safety is only guaranteed when trained Agfa personnel has installed the digitizer WARNING All Agfa medical products must be used by Agfa trained and qualified personnel WARNING The user is responsible for judging image quality and controlling environmental conditions for diagnostic softcopy or print viewing WARNING The user must be aware that any error crash lock up leading to an image processing failure can cause loss of diagnostic information WARNING The user must follow the hospital quality assurance procedures for covering the risks resulting from errors in the image processing WARNING The digitizer is not suitable for scanning imaging plates IPs exposed with a dose higher than 5000 uG Caution Position the digitizer so that it is possible to disconnect the mains power connection if required Caution The following actions may lead to serious risk of injury and damage to the equipment as well as making the warranty void Changes additions or maintenance to the Agfa products carried out by persons without appropriate qualifications and training Using unapproved spare parts Caution To avoid images being lost due to a power failure the workst
23. ealthCare N V Septestraat 27 2640 Mortsel Belgium Agfa HealthCare N V Fax 32 3 444 7094 2491A EN 2012 04 06 Introduction 15 CR 10 X Compatibility The digitizer must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible A list of such equipment and components is available from Agfa service on request Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa Such changes must comply with best engineering practices and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital Accessory equipment connected to any interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult your local service organization Introduction 2491A EN 2012 04 06 CR 10 X Compliance The digitizer has been designed in accordance with the MEDDEV Guidelines relating to the application of Medical Devices and have been tested as
24. he device should ensure that it is used in such an environment Tests of Resistance IEC 60601 Level of Electromagnetic to Disruption Test Level Agreement Environment Use portable and mobile 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 equation suitable for the transmission frequency Recommended protective distance Conducted high frequency disturbance variables in 150 kHz accordance with to 80 MHz IEC 61000 4 6 Radiated high frequency disturbance 3 V m variables in 80 MHz d 12 JP 80 MHz to 800 MHz accordance with to 2 5 GHz IEC 61000 4 3 With P as the rated power of the transmitter in watts W in accordance with the manufacturer information on the transmitter and d as the recommended protective distance in metres m The field strength of stationary radio transmitters is lower than the level of the agreement at all frequencies in accordance with an on site investigation Disruptions are possible near devices that carry the following symbol ko 64 2491A EN 2012 04 06 CR 10 X e REMARK 1 The higher value will apply at 80 MHz and 800 MHz e REMARK 2 These Guidelines may not apply to all situations The dispersion of electromagnetic waves is influenced by absorption and reflections from buildings objects and people a The field strength of stationary transmitters such as ba
25. he technical concept does not allow the user to remove the top cover 2491A EN 2012 04 06 Operating CR 10 X 49 CR 10 X To remove a jammed image plate Caution In case of an image plate jam do not push the release button unless the status indicator constantly lights up in green Pushing the cassette release button while the status indicator is blinking may damage the image plate 1 Switch off the digitizer and switch it on again During startup the digitizer tries to return the image plate into the cassette 2 Ifthe status indicator constantly lights up in green the image plate is returned into the cassette Push the cassette release button and remove the cassette from the cassette slot 3 Ifthe status indicator does not constantly light up in green continue with the next steps 4 Switch off the digitizer 5 Simultaneously press the two buttons positioned underneath the cassette unit 50 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X 6 Slide out the cassette unit with the cassette attached 7 Remove the jammed image plate and insert it in the cassette Ifthe image plate is inside the cassette Caution The image plate may slide out of the cassette Be careful not to drop the image plate 1 Put the cassette unit with the cassette on a table 2 Slide the image plate completely into the cassette 3 Push the release button to detach the cassette from the cassette unit E
26. ically returns to standby mode For more information refer to Re erasing an Image Plate on page 41 Status Indicator The indicator informs the user by light signals about the status of the digitizer It is positioned at the front of the digitizer so that it is visible from a distance Constant Color ae 4 Status Action Blinking Activating the erasing Insert cassette to erase the Blue Constant cycle image plate e Standby mode e Proceed Read Constant y e Cassette is ready for e Remove cassette Green removal Busy with scanning Blinking erasing and return of the Wait IP into cassette a User Interface messages on Blinking Digitizer not ready the control PC Refer to section slowly Troubleshooting Red BA l Digitizer not connected Blinking fast to Error Viewer UI Refer to section Blinking 3 Digitizer not connected Troubleshooting pulses to control PC 2491A EN 2012 04 06 Introduction CR 10 X System Documentation The documentation shall be kept with the system for easy reference Technical documentation is available in the product service documentation which is available from your local support organization The user documentation consists of CR 10 X User Documentation CD digital media NX User Documentation CD digital media Getting Started material The CR 10 X User Documentation contains CR 10 X User Manual this document document 2491
27. izer is used to scan an X ray exposed image plate it results into a digital image which is sent to the dedicated workstation The modality workstation is used to process and route the digital images from the digitizer Intended User This manual has been written for trained users of Agfa products and trained diagnostic X ray clinical personnel who have received proper training Users are those persons who actually handle the equipment and those who have 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 2491A EN 2012 04 06 Introduction CR 10 X Configuration The system consists of e the CR 10 X digitizer for image plates retaining latent X ray images The digitizer accepts one cassette containing one image plate at a time e cassette and plate system CR MD1 0 General The digitizer can be used in combination with e the NX workstation a CR workstation for image acquisition identification image processing and image transmission of digitized images received from the digitizer e UPS optional the uninterruptible power system UPS protects the PC when the main power supply has crashed and avoids the loss of images UPS configuration requires special software This software will be installed and configured by an Agfa service technician CC f digitizer Control PC
28. l is to be performed 2 Prepare the image for diagnosis by using e g L R markers or annotations 3 Ifthe image is OK send the image to a hardcopy printer and or PACS Picture Archiving and Communication System Step 4 Remove the cassette and insert the next one At the digitizer 1 When the digitizer has finished treating the cassette the status indicator constantly lights up in green 2 Push the Cassette release button and remove the cassette from the cassette slot Note When you unlock the cassette it is ready to be re used immediately However if you leave it for more than 2 days before re using it you must re erase it first The procedure how to re erase an image plate is described in Re erasing an Image Plate on page 41 37 2491A EN 2012 04 06 Getting Started with the CR 10 X CR 10 X Stopping the Device Before Switching Off Check that the digitizer is not scanning an image plate If the digitizer is scanning an image plate the status indicator is blinking green Switching Off It is recommended to switch off the digitizer at the end of the day Note Only switch off the digitizer if you do not intend to digitize emergency image plates overnight Switching on the digitizer takes approximately 3 minutes During this time emergency digitizing is not possible To switch off press the power button Power button 38 Getting Started with the CR 10 X 2491A EN 2012
29. locking mechanism inside the digitizer Make sure that the cassette is firmly pushed into the slot so that it is locked you should hear a click Otherwise the digitizer cannot read the image plate Note The cassette is unidentified so the digitizer will send a request to the NX station The NX software must be operational otherwise the digitizer is locked and the status indicator is blinking red The digitizer sends a request to the NX station 2491A EN 2012 04 06 Getting Started with the CR 10 X 35 36 CR 10 X At the NX workstation 1 Inthe Examination window of NX select the thumbnail in the Image overview pane and click ID to send the data to the digitizer Elisabeth Sewell 12 12 1983 Patient Image Overview 0 1 Name Glaabeth Sevwill M89745 12 12 1983 00 00 00 Femate PORTRAIT j ADYT 2 As soon as the digitizer has received the complete identification data from the NX station via Ethernet it will start digitizing the image plate The digitizer converts the information of the latent image to digital data 3 After digitizing the digitizer e Transmits the digital image data to the image processing station destination e Erases the image plate and re inserts it into the cassette Getting Started with the CR 10 X 2491A EN 2012 04 06 CR 10 X Step 3 Perform a quality control At the NX workstation 1 Select the image on which quality contro
30. mponents inside the digitizer require cleaning by the user 4 Plug the power plug into the socket Switch on the UPS if installed 24 Introduction 2491A EN 2012 04 06 CR 10 X Patient data security It is the responsibility of the hospital to ensure how the patients legal requirements are to be met how the security of the patient records are e maintained and tested e audited e administered locally to cover risks from third party access e how the availability of the services is to be maintained in the event of disaster It is the responsibility of the hospital to ensure how types of access are identified classified and reasons for access are justified 2491A EN 2012 04 06 Introduction CR 10 X Maintenance Preventive Maintenance No regular preventive maintenance is required other than described further in this chapter Cleaning and Disinfection Refer to section Cleaning and Disinfection on page 24 Introduction 2491A EN 2012 04 06 CR 10 X Environmental Protection WEEE end user information On August 13 2005 the European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 EC amended by Directive 2003 108 EC came into force aims to prevent the generation of electric and electronic waste and to promote the reuse recycling and other forms of recovery It therefore requires the collection of WEEE recovery and reuse or recycling This directive has to be
31. n 40 200 Hz 1m s sinusoidal vibration Physical emissions e Standby 30 W 102 BTU h e Average power consumption during J scanning 45 W 153 BTU h e Peak power consumption during scanning 85 W 290 BTU h Estimated product life if regularly serviced and maintained 7 yrs according to Agfa instructions 1 BTU British Thermal Unit Equipment Information Sheet 2491A EN 2012 04 06 CR 10 X Remarks for HF emission and immunity The device has been tested for a normal hospital environment as described below The user of the device should ensure that it is used in such an environment Nevertheless the HF emission and immunity can be influenced by connected data cables depending on length and the manner of installation Electromagnetic Environment Guidelines The digitizer uses RF energy only for its eee internal function Therefore its RF RF emissions in accordance with me CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions in accordance with Class A The digitizer is suitable for use in all CISPR 11 establishments other than domestic and Hanmoni eniecone ii m may i used in Teo ene aes accordance with IEC 61000 3 2 and those directly connected to the public Emissions test Compliance low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded WARNING
32. n 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 stipulates that medical devices should only be sold to distributed and used by or by order of a licensed physician 2491A EN 2012 04 06 Introduction CR 10 X Introduction to CR 10 X This section covers the following topics Intended Use Intended User Configuration Operation Controls System Documentation Training Product Complaints Compatibility Compliance Connectivity Installation Labels Cleaning and Disinfection Patient data security Maintenance Environmental Protection Safety Directions Quality Control Introduction 2491A EN 2012 04 06 CR 10 X Intended Use The digitizer is part of a CR system further containing a cassette image plate and modality workstation The CR system is used in a radiological environment by qualified staff to read out process and route static X ray radiographic images The cassette is used to protect the image plate from light and damages during X ray exposure transport and handling The image plate is used to capture the static X ray radiographic images the image plate is scanned by the digitizer The digit
33. not the digitizer returns to the standby mode To re erase an image plate 1 Check that the digitizer is ready for operation The status indicator is continuously lighting up in green 2 Press the erase button at the front side The status indicator is continuously lighting up in blue 41 2491A EN 2012 04 06 Operating CR 10 X CR 10 X 3 Insert the cassette containing the image plate into the cassette slot as shown below Make sure to insert the cassette with the black side to the top and with the shutter opening mechanism and the locking mechanism inside the digitizer Make sure that the cassette is firmly pushed into the slot Otherwise the digitizer cannot read the image plate As aresult the digitizer starts erasing the image plate the status indicator switches to the state blue blinking When the digitizer has finished erasing the cassette the status indicator is constantly lit in green 4 Push the cassette release button and remove the cassette from the cassette slot 5 To erase a second cassette the erase mode has to be accessed again 42 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X Reading the Initialization Data of an Image Plate The initialization data stored in the IP barcode can be read via the digitizer Reading the initialization data of an image plate can be necessary in case you want to find a specific IP To read the initialization data
34. nuals should be consulted before making any connections to other equipment The use of accessory equipment not complying with the equivalent safety requirements of this digitizer may lead to a reduced level of safety of the resulting system Consideration relating to the choice of accessory equipment shall include e Use of the accessory equipment in the patient vicinity e Evidence that the safety certification of the accessory equipment has been performed in accordance with the appropriate IEC 601 1 and IEC 601 1 1 harmonized national standard In addition all configurations must comply with the medical electrical systems standard IEC 601 1 1 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 In order to reduce the risk of electric shock do not remove any covers Caution hot Keep hands clear from the erasure unit Power button 2491A EN 2012 04 06 Introduction CR 10 X Sectoid wal Septestraat 27 2640 Morts Type 5151 100 SN xxxxx w YYYY MM DAN AAs ceeneceeceeeseneeseenescnng Type label Made in Germany eissenberg MMMMM YYYYT Date of manufacture Manufacturer Introduction 2491A EN 2012 04 06 CR 10 X Safety Instructions for Laser Products The digitizer is a Class 1 Laser Product It uses one laser diode of a 80 mW type
35. pment Information Sheet 2491A EN 2012 04 06 CR 10 X Power consumption e 110 V 240 V 50 60 Hz configuration e 110 V 240 V 50 60 Hz configuration Uninterruptible power supply optional 120 V UPS Powerware 5115 ABC ordering code EGPSE 230 V UPS Powerware 5115 ABC ordering code EGPTG Environmental conditions recommended 20 C 25 C allowed 15 C 35 C Maximum temperature change 0 5 C min recommended 30 60 allowed 15 80 Magnetic field compliant with EN 61000 4 8 Level 2 A E deh ae not to be operated in direct sunlight max Gr EAP 2500 lux Environmental conditions during storage In line with IEC721 3 1 class 1K4 Temperature 29 Getroo G Environmental conditions during transport In line with IEC721 3 2 1997 class 2K2 and 2M3 with following restrictions Room temperature Relative humidity Temperature 29 G 55 C 5 200 Hz vertical longitudinal transversal Vibration ig 59 2491A EN 2012 04 06 Equipment Information Sheet CR 10 X Environmental conditions for mobile installation during transport In line with IEC721 3 5 5K1 and 5M3 with following restrictions 5 150 Hz all axis 1m s sinusoidal vibration Environmental conditions for mobile installation during operation In line with IEC721 3 3 1997 3K2 and 3M1 with following restrictions Temperature PS C1039 C Relative Humidity 15 to 75 non condensing Vibratio
36. roblem occurred a Error Viewer bene Condition Status indicator Action message Connection problem between digitizer and the Error Viewer Connection problem between digitizer and NX PC 48 Operating CR 10 X No error message on NX PC Red blinking fast Red blinking 3 pulses Check if Error Viewer is running Start restart Error Viewer Check the Ethernet cables If the error remains restart PC and digitizer or call service 2491A EN 2012 04 06 CR 10 X Cassette Could Not Be Identified This error message is displayed on the NX PC Identify Cassette The cassette could not be identified No cassette x could be found Ref MESS56 To identify a cassette insert it in the digitizer Cancel Cause A cassette has been inserted in the digitizer and the ID button was clicked directly afterwards Solution Wait until the digitizer has read the data on the cassette and sent it to the NX PC This may take a few seconds The error message will disappear Removing a Jammed Image Plate Note The digitizer always reads and digitizes the plate first then erases it and transports it back into the cassette If a plate jam occurs before the plate is scanned there is a fair chance that you can recover the image by putting the image plate back into the cassette and digitizing it again While handling the image plate prevent exposing it to daylight as much as possible Vv Note T
37. s lt 5 U 95 breakthrough of U for 5 s 6 kV contact discharge 8 kV air discharge 2 kV for network leads 1 kV for entry and outlet leads 1 kV push pull voltage 2 kV common mode voltage e lt 5 U gt 95 breakthrough of U for 1 2 period 40 U gt 60 breakthrough of U for 5 periods 70 U 30 breakthrough of U for 25 periods lt 5 U 95 breakthrough of U for 5 s Floors should consist of wood concrete or ceramic tiles The relative humidity must be at least 30 if the floor is made of synthetic material The quality of the voltage supplied should correspond to a typical commercial or clinical environment The quality of the voltage supplied should correspond to that of a typical commercial or clinical environment The quality of the voltage supply should correspond to that of a typical commercial or clinical environment If the user wants the device to work continuously even when the energy supply is interrupted it is recommended to use an uninterruptible power supply or a battery Magnetic field at the network frequency should correspond to the typical values as they are ina commercial and clinical environment e REMARK U is the alternating current in the network before the application of the test level 2491A EN 2012 04 06 CR 10 X This device is intended for operation in the electromagnetic environment given below The user of t
38. s information for safe and effective operation of the CR 10 X digitizer further referred to as the digitizer Warnings Cautions Instructions and Notes The following samples illustrate how warnings cautions instructions and notes appear in this document The text explains their intended use WARNING Warnings are directions which if they are not followed can cause fatal or serious injuries to a user engineer patient or any other person or can lead to a mistreatment The purpose of safety icons is to indicate at a glance the type of caution warning or danger A A AX AAA Introduction 2491A EN 2012 04 06 CR 10 X Caution Cautions are directions which if they are not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution Instruction This sign is used typically in combination with the warning sign when providing a specific instruction which if followed exactly should avoid the subject of the warning Note Notes provide advice and highlight unusual points A note is not intended as an instruction Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes have been made to the content or format Every care has been taken to ensure the accuracy of the information in this document However Agfa assumes no responsibility or liability for errors inaccuracies or omissions that may appear i
39. s sannssndiangsse ea tanbina extortion eenasaueediadaels 32 De A EE enemas 33 OR I re aa eee eres 38 Chapter 3 Operaning CB ssrin 39 Reading an Emergency Image Plate eseoeosesseoessesseseosesecsessesesseseosesseseo 40 Re erasing an Image Plate seseesesscsessesecscsseseoscscosecsescesesecsessesecsessesesse 41 Reading the Initialization Data of an Image Plate cssccsseeoseeeees 43 Eoy ol linage PROE sana 45 Upcoming Exar OF tie Image Flai caniae 45 a a gL 1 Scene en eT RE new Per UneT ORee ae ree Pre On Nee MeT ccoraee erry 45 2491A EN 2012 04 06 CR 10 X EOC AO a 46 iinet A nh a eee anne ne te Reo RU EE ot ane ERE EIA SY DE ene Re EAEN DENE AE nn enc AE ee 47 BI at caisson RE teen sees 48 Cassehe Cit Not Be IO CH ICO essre 49 Remy a Jae 1 6 PI irs onsite 49 Behavior in Case of Power Pa i erieieretintenincniemineiaumns 54 Ae taan LE ae I E a A T A I AENA E E EATI N EAA ao Appendix A Equipment Information Sheet csssccceseeeeeees 57 SPee E O E 58 Appendix B Remarks for HF emission and immunity 61 Remarks for HF emission and immunity sccssscossccssccssecssccsceesces 62 2491A EN 2012 04 06 Introduction to this Manual Introduction to CR 10 X CR 10 X Introduction to this Manual This section covers the following topics M Scope E Warnings Cautions Instructions and Notes W Disclaimer Scope This manual contain
40. se button and remove the cassette from the cassette slot Note You can only remove the cassette from the cassette slot when the cassette is unlocked 44 Operating CR 10 X 2491A EN 2012 04 06 CR 10 X Expiry of Image Plates Upcoming Expiry of the Image Plate The digitizer Error Viewer informs you about upcoming expiry of the image plate 90 and 30 days before the expiry date Please replace the image plates before expiry to avoid reduced system performance Expired Image Plate The digitizer Error Viewer informs you about reduced system performance whenever you use an expired image plate The expiry date is printed on the image plate Refer to the Agfa CR Plates and Cassettes CR MD1 0 General User Manual document 2492 45 2491A EN 2012 04 06 Operating CR 10 X CR 10 X Troubleshooting In case of a malfunction of the digitizer consult the Error Viewer UI User Interface messages on the control PC Error messages are displayed in a dialog box in the middle of the screen or ina fixed part of the screen These messages will tell that either a problem has occurred or that a requested action cannot be performed The user must read these messages carefully They 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 whi
41. se 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 strength of the device exceeds the level of agreement given above the device must be observed with regard to its normal operation at each place of use In case of unusual performance characteristics it can be necessary to take additional measures such as the re orientation of the device for example b The field strength will be lower than 3 V m above the frequency range from 150 kHz to 80 MHz 2491A EN 2012 04 06 65 CR 10 X 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 disruptions by maintaining the minimum distances between portable and mobile high frequency communication equipment transmitters and the device as recommended below in accordance with the maximum output power of the communications equipment Recommended Protective Distances between Portable and Mobile High Frequency Communication Equipment and the Device Rated Power of Protective Distance in accordance with Transmission Frequency the Transmitter 150 kHz to 80 MHz 80 MHz to 800
42. tion in such a way that the annual dose equivalent at the place of installation will not exceed 1 mSv a 2491A EN 2012 04 06 Introduction CR 10 X Caution If the digitizer is installed inside an X ray room it must be protected from stray radiation by proper shielding WARNING The device is a table top digitizer The structure and stability of the table used need to be suitable in relation with the size and weight of the system Do not use excessive force when inserting cassettes in the digitizer as the device may slip or drop off the table Use a non slip mat below the digitizer or other anti skid measures The table should not be subject to excessive shock and vibrations from other sources as this may disturb the operation of the digitizer The digitizer complies with the EN 60601 1 and UL 60601 1 standards for Medical Electrical Equipment This means that although it is absolutely safe patients may not come in direct contact with the equipment Therefore the operator console must be placed outside a radius of 1 5 m EN or 1 83 m UL around the patient according to the local valid regulation ao a R 1 5 m 1 83 m 20 Introduction 2491A EN 2012 04 06 CR 10 X Labels General Always take into account the markings and labels provided on the inside and outside of the machine A brief overview of these markings and labels and their meaning is given below Safety warning indicating that the ma
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