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2386G EN 20120110

Equipment Information Sheet

CR 30-X/CR 30-X

Specifications

Labelling

93/42 EEC 'Medical Devices' (Europe),
EN 60601-1

c ETL us

ETL us certified, UL 60601-1 Second Edition
(North America)

c ETL us

c ETL certified CSA 22.2 No 601.1

Dimensions

Length

786 mm

Width

693 mm

Height

525 mm

Weight

Unpacked

approximately 72 kg (158.73 lb)

Electrical connection

Operating voltage

Autoranging power supply from: 100 V to
240 V, ac

10%

Class I with protection earth
Connect to earthed supply circuitry only.

Mains frequency

50/60 Hz

Current rating

1A 2A

Mains fuse protection

Europe: min. 10 A, max. 16 A
USA & Japan: min. 10 A, max. 15 A

Mains frequency

50/60 Hz

Network connectivity

Ethernet connector

RJ45 female, 10/100 Mbit/s autosensing,
shielding CAT5

Содержание 5175/200

Страница 1: ...CR 30 X type 5175 200 5175 205 CR 30 Xm type 5179 100 User Manual m 2386G EN 20120110 ...

Страница 2: ...nd 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 cir...

Страница 3: ...3 Compliance 14 Connectivity 16 Installation 16 Product Identification 19 Labels 20 Cleaning and Disinfection 23 Patient data security 24 Maintenance 25 Environmental Protection 28 Safety Directions 29 Quality Control 32 Chapter 2 Getting Started with the CR 30 X CR 30 Xm 33 Basic Features 34 CR 30 X CR 30 Xm Features 34 Operating Modes 35 The User Interface 36 Starting the Device 38 Basic Workflo...

Страница 4: ...ge Plate 45 Troubleshooting 46 Troubleshooting Checklist 46 Removing a Jammed Image Plate 50 Behavior in Case of Power Failure 52 Appendix A Equipment Information Sheet 53 Specifications 54 Appendix B Remarks for HF emission and immunity 59 Remarks for HF emission and immunity 60 ...

Страница 5: ...Introduction This chapter covers the following topics T Introduction to this Manual T Introduction to CR 30 X CR 30 Xm Chapter 1 ...

Страница 6: ...and CR 30 XmTM 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 The purpose of safety icons is to indicate at a glance the type of caution warning or danger WARNING Warnings are directions which if they are not followed can cause fatal or serious injuries to ...

Страница 7: ... implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose 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 w...

Страница 8: ... covers the following topics Q Intended Use Q Intended User Q Configuration Q System Documentation Q Training Q Product Complaints Q Compatibility Q Compliance Q Connectivity Q Installation Q Labels Q Cleaning and Disinfection Q Patient data security Q Environmental Protection Q Safety Directions ...

Страница 9: ...ation is further processed and routed It is intended that this device is only operated in a radiological environment by qualified staff 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 equipmen...

Страница 10: ...on data are transmitted from the workstation to the digitizer via DICOM Ethernet For more information refer to the workstation s On line Help manuals or contact your local service organization For more information refer also to the CR 30 X CR 30 Xm System User Manual document 2385 Caution The digitizer must not be connected to any version of the Agfa ADC QSTM or ADC VIPSTM software digitizer Contr...

Страница 11: ...nd a System Safety User Manual document 3100 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 Refer to the CR 30 X CR 30 Xm System User Manual document 2385 before operating the product ...

Страница 12: ...ry section of this manual Q Intended Use Q Intended User Q 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 seriou...

Страница 13: ...egulations 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 additio...

Страница 14: ... regulations IEC 60601 1 EN 60601 1 IEC 60601 1 1 2000 EN 60601 1 1 2001 IEC 62304 2006 EN 62304 2006 IEC 60601 1 6 2006 EN 60601 1 6 2007 IEC 60601 1 2 2007 EN 60601 1 2 2007 UL 60601 1 2003 CAN CSA C22 2 No 601 1 ISO 14971 2009 Medical devices Application of risk management to medical devices the laser safety regulations IEC 60825 1 2001 EN 60825 1 1994 A1 2002 A2 2001 IEC 60825 1 2007 EN 60825 ...

Страница 15: ...fa has produced a CB test report and claims national certification in all other member countries of the CB Scheme 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 ...

Страница 16: ...zer 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 Caution The digitizer and the cassette storage shall be protected against direct radiation in such a way that the annual dose equivalent at the place of installation will...

Страница 17: ...ansport The check is done with a flat field exposure and should be performed with a cassette of the largest format used at customer site 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 The table should not be subject to excessive shock and vibrations from other sources as this may distu...

Страница 18: ...ed and no rotation of the cassette Remove the compression paddle before the exposure Tape an Aluminum filter at the tube exit Insert the cassette in the bucky and make an exposure with the following settings 28 kV 200 mAs Mo Mo large focus 2 0 mm Aluminum filter If this leads to an overexposure the mAs setting can be reduced but it should not be lower than 50 mAs Identify the cassette as System Di...

Страница 19: ...r Commercial name CR 30 X Model number 5175 200 5175 205 Original seller manufacturer Agfa HealthCare N V Septestraat 27 2640 Mortsel Belgium CR 30 Xm product description Type of product Table top digitizer Commercial name CR 30 Xm Model number 5179 100 Original seller manufacturer Agfa HealthCare N V Septestraat 27 2640 Mortsel Belgium ...

Страница 20: ...C 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 ...

Страница 21: ...te as described in the basic workflow of the CR 30 X CR 30 Xm System User Manual document 2385 Off power disconnection from the mains On power connection to the mains Note The type label of the CR 30 Xm digitizer is placed at the chassis in the upper left corner when opening the front cover ...

Страница 22: ...te jam can occur in the post scan area However the user is allowed to open the front cover e g to solve cassette or image plate jams at the front side When opening the front panel all motor driven system movements will be stopped including the laser WARNING User interventions other than those described in this manual can be hazardous with regard to laser radiation CAUTION CLASS 3B LASER RADIATION ...

Страница 23: ...instructions of the plates and cassettes refer to the CR 30 X CR 30 Xm Plates and Cassettes User Manual 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 4 Plug the powe...

Страница 24: ...re to be met how the security of the patient records are maintained and tested audited administered locally to cover risks from third party access 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 ...

Страница 25: ...ance by appropriately certified people can have impact on warranty commitments Cleaning and Disinfection Refer to section Cleaning and Disinfection on page 23 Cleaning the optical unit The only maintenance action which you must perform is checking the image quality Refer to the User Manual of the NXTM Software Cleaning the optic unit is required if stripes parallel to the image plate movement can ...

Страница 26: ...26 2386G EN 20120110 Introduction CR 30 X CR 30 XM To clean the optic unit proceed as follows 1 Open the cassette unit 2 Take out the cleaning brush 3 Open the lid positioned at the right side Open lid ...

Страница 27: ... Clean the scan line Your last movement must be continuous from the rear to the front 5 Re insert the cleaning brush 6 Close the cassette unit Caution Misuse of the bowden wire leads to bending which causes a complicated replacement of the cleaning brush ...

Страница 28: ...d 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 th...

Страница 29: ...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 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 equi...

Страница 30: ...ation 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 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...

Страница 31: ...ns 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 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 sw...

Страница 32: ...ions are valid a regular quality control by means of the Agfa Auto QC2 tool is required at least once a month to maintain a safe and effective system For mammography Agfa recommends to use the Routine Quality Control Tests for Full Field Digital Mammography Systems document created by the NHSBSP National Health Service Breast Screening Program UK ...

Страница 33: ...e CR 30 X CR 30 Xm This chapter explains how to perform the first basic actions on the digitizer This chapter covers the following topics T Basic Features T Starting the Device T Basic Workflow T Stopping the Device Chapter 2 ...

Страница 34: ...data to the preview station erases the image plate and re inserts it into the cassette gives the image plate ID data the status erased unlocks the cassette transmits the digital image data to an image processing station destination Q The digitizer permits assigning the status emergency to an image Q The digitizer permits re erasing an image plate before reusing it In specific cases this is necessa...

Страница 35: ...oups all basic functions which are aimed at radiographers Reading an image plate Reading an emergency image plate Re erasing an image plate Reading the identification data of a cassette All functions of the operator mode are described in this manual Service Mode The service mode functions are reserved for trained service personnel They are password protected and they are described in a separate do...

Страница 36: ...n two modes the operator mode for basic operation the service mode reserved for trained service personnel The functions of the operator mode are described in this manual The digitizer interfaces with the user via an erase button a status indicator 1 2 1 Status indicator 2 Erase button 3 DICOM Ethernet connection 4 Main switch 4 3 ...

Страница 37: ...s 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 The indicator is divided in two parts The upper part is used to inform the operator about the image plate erasing cycle progress and is only then lit The lower part is used for all other operational indications Color Constant Flashing Status Action Blue...

Страница 38: ... the following operation sequence initialization of all components functional test of all components check for presence of cassettes and or IPs establish connection to the Control PC During the self test which may take up to 60 seconds the digitizer status indicator is flashing red If the digitizer has completed the self test successfully the digitizer enters the operator mode and the status indic...

Страница 39: ...CR 30 XM Basic Workflow Briefly The digitizer starts reading out the image plate as soon as it has received the complete identification data from the NX Station via DICOM Ethernet Note The basic workflow is described in the CR 30 X CR 30 Xm System User Manual document 2385 ...

Страница 40: ...age plate the status indicator is flashing green Switching Off It is recommended to switch off the digitizer at the end of the day To switch off press the main switch to the Off 0 position Note Only switch off the digitizer if you do not intend to digitize emergency image plates overnight Switching on the digitizer takes approximately 60 seconds During this time emergency digitizing is not possibl...

Страница 41: ...ailable in operator mode Finally you will find some preventive maintenance and troubleshooting guidelines This chapter covers the following topics T Reading an Emergency Image Plate T Re erasing an Image Plate T Reading the Initialization Data of an Image Plate T Troubleshooting Chapter 3 ...

Страница 42: ...ge Plate Briefly In emergency situations it is possible to open an emergency exam at the NX workstation without patient details and to digitize without having identified the cassette Note Reading an emergency image plate is described in the CR 30 X CR 30 Xm System User Manual document 2385 ...

Страница 43: ...age plate may still retain a latent image after standard erasure Leave the image plate to rest at least one day before re erasing it 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 upper part of the status indicator is continuously lighting up in blue The lower part...

Страница 44: ...ushed up to the right side of the slot 2 Otherwise the digitizer cannot read the image plate As a result the digitizer starts erasing the image plate The upper part of the status indicator is continuously lighting up in blue The lower part of the status indicator is flashing green When the digitizer has finished erasing the cassette the upper part of the status indicator is not lit and the lower p...

Страница 45: ...eading the Initialization Data of an Image Plate Briefly The initialization data stored in the RF tag of the tray can be read via the digitizer Note Reading the Initialization Data of an Image Plate is described in the CR 30 X CR 30 Xm System User Manual document 2385 ...

Страница 46: ...he status indicator on the digitizer Other errors need more detailed information and instructions to repair the malfunction or they can only be fixed by a Service engineer In this case consult the ASAP UI Agfa Service Access Package User Interface messages on the control PC General Errors Error Action The digitizer does not start up Check the power supply If the power supply is ok call your local ...

Страница 47: ...mpty cassette and restart the digitizer Red constant Switch off the digitizer and open the front cover see page 50 If there is no image plate visible in the transport unit close and switch on the digitizer After restart remove the cassette from the digitizer and check if there is an image plate inside the cassette In case of an image plate jam remove the plate from the transport unit manually and ...

Страница 48: ... Image plate during self test in the digitizer detected The image plate was moved back into the cassette Please check whether the image is present at the PC and re scan the cassette if necessary If the image is present the cassette was not erased possibly Erase the cassette again in any case Red flashing After unlocking green constant After power failure a remaining image plate in the digitizer wi...

Страница 49: ...he Ethernet cable is damaged If the error remains restart PC and digitizer or call service Time out after 5 minutes if the ID button of the image processing software was not pressed ID button not pressed within the timeout period Image plate was not scanned Cassette stays clamped until ID data are supplied by the operator After ID button has been pressed green flashing Confirm the message on the P...

Страница 50: ...ath the feed table Note The technical concept does not allow the user to remove the top cover The concept provides maximum reliability that no image plate jam can occur in the post scan area 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 recov...

Страница 51: ...e front cover 3 Remove the jammed image plate 4 Close the front cover 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 After a jam the image plate can be used again if not damaged ...

Страница 52: ...the power supply returns the cassette must be inserted into the digitizer and identified again to read out the image 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 Note The description below is...

Страница 53: ...Equipment Information Sheet This appendix covers the following topic T Specifications Appendix A ...

Страница 54: ...Width 693 mm Height 525 mm Weight Unpacked approximately 72 kg 158 73 lb Electrical connection Operating voltage Autoranging power supply from 100 V to 240 V ac 10 Class I with protection earth Connect to earthed supply circuitry only Mains frequency 50 60 Hz Current rating 1A 2A Mains fuse protection Europe min 10 A max 16 A USA Japan min 10 A max 15 A Mains frequency 50 60 Hz Network connectivit...

Страница 55: ...E UPS Powerware 5115 230 V ABC ordering code EGPTG Environmental conditions Room temperature recommended 20 C to 25 C allowed 15 C to 30 C Maximum temperature change 0 5 C min Relative humidity recommended 30 to 60 allowed 15 to 75 non condensing Magnetic field compliant with EN 61000 4 8 Level 2 Sunlight exposure not to be operated in direct sunlight max 2500 lux Environmental conditions during s...

Страница 56: ...0 200 Hz 1m s sinusoidal vibration Warming up time Cold start fully operational after max 30 min Warm start fully operational after self test on condition that the digitizer has not been switched off for more than 3 minutes has been operational for at least 30 minutes Physical emissions Noise emission sound power level according to ISO 7779 During scanning max 65 dB A Standby max 55 dB A Heat emis...

Страница 57: ...Information Sheet CR 30 X CR 30 XM 1 BTU British Thermal Unit Preventive maintenance Preventive maintenance frequency Note Needs to be done by an Agfa certified field service engineer Once a year or 12000 cycles whatever comes first ...

Страница 58: ...58 2386G EN 20120110 Equipment Information Sheet CR 30 X CR 30 XM ...

Страница 59: ...Remarks for HF emission and immunity Appendix B ...

Страница 60: ...ot likely to cause any interference in nearby electronic equipment RF emissions in accordance with CISPR 11 Class A The digitizer is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heed...

Страница 61: ... kV common mode voltage 1 kV push pull voltage 2 kV common mode voltage The quality of the voltage supplied should correspond to that of a typical commercial or clinical environment Voltage breakthroughs short term interruptions and variations in the voltage supplied in accordance with IEC 61000 4 11 5 Ur 95 breakthrough of Ur for period 40 Ur 60 breakthrough of Ur for 5 periods 70 Ur 30 breakthro...

Страница 62: ...transmission frequency Recommended protective distance Conducted high frequency disturbance variables in accordance with IEC 61000 4 6 3 Veff 150 kHz to 80 MHz 3 Veff d 1 2 Radiated high frequency disturbance variables in accordance with IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz With P as the rated power of the transmitter in watts W in accordance...

Страница 63: ... 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 t...

Страница 64: ...y m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 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 manufacturer information on the transmitter only for transmitters where the rated power is not ...

Страница 65: ...65 2386G EN 20120110 CR 30 X CR 30 XM ...

Страница 66: ...0413 Printed in Belgium Published by Agfa HealthCare N V B 2640 Mortsel Belgium 2386G EN 20120110 ...

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