AGFA FXRD-2530VAW User Manual Download Page 33

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General

• The product has been designed in accordance with the MEDDEV

Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).

• ISO 13485
• ISO 14971

Safety

• IEC 60601-1
• AAMI ES 60601-1
• CSA C 22.2 No.60601-1

Electromagnetic Compatibility

• IEC 60601-1-2

Radio Frequency

Declaration of conformity

U.S.A.

FCC Part 15.107(b) / Part 15.109(b)
FCC Part 15 Subpart E 15.407
FCC Part 15 Subpart C 15.247

European Un-

ion (and EEA)

ETSI EN 301 489-1 V2.1.1
ETSI EN 301 489-17 V3.1.1
EN 300 328 V2.1.1
EN 301 893 V2.1.1

South Korea

KN 301 489-1
KN 301 489-17

Brazil

ANATEL This product contains the module WLE900VX

7AA000S-VW, ANATEL ID: 05379-20-05431

Related Links

Remarks for HF-emission and immunity

on page 128

Topics:

XD 10, XD

⁺

10 | Introduction to the DR Detector |

0432A EN 20210426 1355

Summary of Contents for FXRD-2530VAW

Page 1: ...XD 10 XD 10 FXRD 2530VAW FXRD 2530VAW PLUS User Manual 0432A EN 20210426 1355 ...

Page 2: ...ol Unit 23 System Control Unit Lite 24 DR detector cable 25 DR Detector Switch 26 System Documentation 28 Wireless access point 28 Training 29 Product Complaints 30 Compatibility 31 Compliance 32 General 33 Safety 33 Electromagnetic Compatibility 33 Radio Frequency 33 Connectivity 35 Wireless Communication 36 Wired communication 37 Installation 38 Environment of Use 38 Messages 40 Labels 41 Additi...

Page 3: ...fety directions for the power supply 70 Safety directions for the System Control Unit 72 Safety directions for the DR detector battery 73 Getting started 75 Starting the DR detector 76 Basic Workflow DR Detector 78 Step 1 retrieve the patient info 79 Step 2 select the exposure 79 Step 3 prepare the exposure 80 Step 4 check the exposure settings 81 Step 5 execute the exposure 82 Step 6 perform a qu...

Page 4: ...t mode 110 Problem solving 111 Artifact in DR Detector images 112 DR detector not ready for exposure 113 The MUSICA Acquisition Workstation is connected to the DR detector but the DR detector is not active access point mode 115 Images are not sent to the printer or to the PACS archive 116 Identifying problems 117 Technical Data 119 XD 10 XD 10 technical data 120 DR detector battery technical data ...

Page 5: ...ty 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 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 u...

Page 6: ...Introduction to this Manual Topics Scope About the safety notices in this document Disclaimer 6 XD 10 XD 10 Introduction to this Manual 0432A EN 20210426 1355 ...

Page 7: ...ns information for the safe and effective operation of the XD 10 and XD 10 wireless DR detectors and peripheral equipment further referred to as the DR detector XD 10 XD 10 Introduction to this Manual 7 0432A EN 20210426 1355 ...

Page 8: ...erson CAUTION 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 follo...

Page 9: ...ns 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 order of...

Page 10: ...ssification Options and Accessories Operation Controls System Documentation Training Product Complaints Compatibility Compliance Connectivity Installation Messages Labels Cleaning and Disinfecting Maintenance Patient data security Environmental Protection Safety Directions 10 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 11: ...i Then the detector digitalizes X ray images and transfers them to the PC workstation for diagnostic review using an image display monitor Advanced digital image processing also allows efficient diagnosis information management and sharing of image information over the network The XD 10 and XD 10 DR detectors are used for the general purpose diagnostic procedures and as well as intended to replace...

Page 12: ...raphic applications to capture for display diagnostic quality radiographic images of human anatomy The DR Retrofit solution may be used wherever conventional screen film systems may be used The DR Retrofit solution is not indicated for use in mammography 12 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 13: ...s 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 Only a physician or a legally certified operator should use this product XD 10 XD 10 Introduction to the DR Detector 13 0432A EN 20210426 1355 ...

Page 14: ...m Control Unit SCU 2 Client mode the detector connects to the workstation via a wireless access point 3 Access point mode the workstation connects to the detector which is acting as an access point 4 Wired mode the detector communicates to the workstation via the DR detector cable 5 DR detector 6 System Control Unit including a wireless access point 7 Workstation 8 Wireless access point 9 DR detec...

Page 15: ...Managing network connections in client mode configuration on page 104 Managing network connections in access point mode configuration on page 106 XD 10 XD 10 Introduction to the DR Detector 15 0432A EN 20210426 1355 ...

Page 16: ...water and dust provided by enclosure Flammable anesthetics This device is not suitable for use in the presence of a flammable anesthetic mixture with air or in presence of a flammable anesthetic mixture with oxygen or nitrous oxide Operation Continuous operation Applied Parts The DR detector tube side is an applied part Expected service life Up to seven 7 years if regularly serviced and maintained...

Page 17: ...er The delivery contains a set of labels When using multiple DR Detector on the labels a nickname is written to identify the DR Detector An identical label is attached to the bucky of the X ray system to identify the dedicated workspace of each DR Detector XD 10 XD 10 Introduction to the DR Detector 17 0432A EN 20210426 1355 ...

Page 18: ...opics XD 10 XD 10 DR detector cradle DR Detector dual battery charger System Control Unit System Control Unit Lite DR detector cable DR Detector Switch 18 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 19: ...ange the network connection 3 Status display Battery status Connection status IP address SSID name 4 Antenna of the wireless network adapter Operation in wireless configuration 5 Battery status indicator 6 Connector for power adapter USB Type C 7 DR detector connector Operation in wired configuration Charging the battery 8 Effective imaging area border and center position indication Figure 2 DR de...

Page 20: ...etector battery The battery supplies power to the detector during wireless communication Figure 3 DR detector rear side Related Links Advanced Operating on page 94 XD 10 XD 10 technical data on page 120 20 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 21: ...e that the battery is fully charged 5 At the rear side Power button Connector for power adapter Figure 4 DR detector cradle WARNING Do not use the DR detector cradle within the patient s vicinity Related Links Charging the DR detector in the DR detector cradle on page 99 DR detector cradle technical data on page 123 Safety directions for the power supply on page 70 XD 10 XD 10 Introduction to the ...

Page 22: ...1 Connector for power adapter 2 Status indicator of the top slot 3 Status indicator of the bottom slot Orange to indicate that the battery is charging Green to indicate that the battery is fully charged Figure 5 DR detector battery charger WARNING Do not use the battery charger within the patient s vicinity 22 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 23: ...n the System Control Unit may not be part of the system 1 2 1 2 1 Power switch 2 Status indicator Blinking green starting up Green ready Blue communicating to the detector Figure 6 System Control Unit SCU and Mini System Control Unit Mini SCU WARNING Do not use the System Control Unit within the patient s vicinity Related Links System Control Unit on page 125 Mini System Control Unit on page 126 S...

Page 24: ...orkstation via wired network Depending on the configuration the System Control Unit Lite may not be part of the system 2 1 1 Power switch 2 Status indicator Green or orange ready Figure 7 System Control Unit Lite WARNING Do not use the System Control Unit within the patient s vicinity Related Links Safety directions for the power supply on page 70 System Control Unit Lite on page 127 Safety direct...

Page 25: ... detector cable can be used for charging the battery of the DR detector to power the DR detector and to transmit image data Related Links Charging the battery using the DR detector cable on page 101 Wired communication on page 37 XD 10 XD 10 Introduction to the DR Detector 25 0432A EN 20210426 1355 ...

Page 26: ... another DR detector Figure 8 DR Detector Switch Figure 9 Title bar with DR Detector Switch Battery status icon empty Meaning Full Medium Low Empty Wired DR Detector Wireless DR detector is off or disconnected Connection sta tus icon wifi wired empty Meaning Good Low Bad Wired DR de tector DR detector is off or disconnected DR Detec tor status icon blinking empty 26 XD 10 XD 10 Introduction to the...

Page 27: ...se lected DR Detector exposure synchronization Automatic expo sure detection icon empty Meaning The active DR Detector is using automatic exposure detection The active DR Detector is using X ray generator syn chronization Note Depending on the installed software version the icon may not be displayed XD 10 XD 10 Introduction to the DR Detector 27 0432A EN 20210426 1355 ...

Page 28: ...ion is described within this manual including the maximum number of options and accessories Not every function option or accessory described may have been purchased or licensed on a particular piece of equipment Technical documentation is available in the product service documentation which is available from your local support organization The most recent version of this document is available on h...

Page 29: ...e user must make sure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa or 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 XD 10 XD 10 Introduction to the DR Detector 29 0432A EN 20210426 1355 ...

Page 30: ...tries with identical regulatory regimes Regulation 2017 745 EU on Medical Devices 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 Contact address Agfa Service Support local support addresses and phone numbers are listed on www agfa com Agfa Septestraat...

Page 31: ...onents 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 practice and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital XD 10 XD 10 Introduction to the DR Detector 31 0432A EN 20210426 1355 ...

Page 32: ...Compliance Topics General Safety Electromagnetic Compatibility Radio Frequency 32 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 33: ...0601 1 Electromagnetic Compatibility IEC 60601 1 2 Radio Frequency Declaration of conformity U S A FCC Part 15 107 b Part 15 109 b FCC Part 15 Subpart E 15 407 FCC Part 15 Subpart C 15 247 European Un ion and EEA ETSI EN 301 489 1 V2 1 1 ETSI EN 301 489 17 V3 1 1 EN 300 328 V2 1 1 EN 301 893 V2 1 1 South Korea KN 301 489 1 KN 301 489 17 Brazil ANATEL This product contains the module WLE900VX 7AA00...

Page 34: ...estrictions on the outdoor use of the U NII Low 5150 5250 MHz and U NII Mid 5250 5350 MHz bandwidths of the WLAN module incorporated in the device in the following Member States Belgium BE Bulgaria BG Czech Republic CZ Denmark DK Germany DE Estonia EE Ireland IE Greece EL Spain ES France FR Croatia HR Italy IT Cyprus CY Latvia LV Lithuania LT Luxembourg LU Hungary HU Malta MT Netherlands NL Austri...

Page 35: ...Connectivity Topics Wireless Communication Wired communication XD 10 XD 10 Introduction to the DR Detector 35 0432A EN 20210426 1355 ...

Page 36: ...ersonnel at the medical site Note Do not place obstacles in the way of the wireless access point or of the antenna of the internal wireless module of the DR detector Otherwise the properties of wireless communication such as the throughput and operable distance may decrease Note Transmitting the image data to the MUSICA Acquisition Workstation takes a number of seconds After making an exposure sta...

Page 37: ...interfaces must be certified according to the respective IEC standards All combinations of equipment must be in compliance with IEC 60601 1 1 system requirements Any person who connects additional equipment to the signal input or signal output ports configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601 ...

Page 38: ...f the locations listed below Doing so may result in failure or malfunction equipment falling or fire or injury Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air conditioner or ventilation equipment Close to a heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment...

Page 39: ... form on the equipment In this case wait until the condensation evaporates before use If the equipment is used while condensation is formed on it problems may occur When an air conditioner is used be sure to raise lower the temperature gradually so that a difference in temperature in the room and in the equipment does not occur to prevent condensation WARNING Do not use non medical equipment in th...

Page 40: ...r 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 the local service organization Details on the contents of messages can be found in the service documentation which is available to local service personnel Related Links Problem solving on page 111 Viewing the detector status on ...

Page 41: ...al connector Provides a connection between the equipment and the potential bus bar of the electrical system as found in medical environments It is recommended to use the equipotential connection as additional safety measure This mark indicates that this is a Type B Equipment Handle with care Maximum patient weight over the whole area of the detector surface Device contains a transmitter module tha...

Page 42: ... gener al household waste This wheeled bin symbol on the products and or ac companying documents means that the used batteries should not be treated as or mixed with general house hold waste Medicine that can only be given by a prescription from a doctor or a doctor s recommendation to use a certain medicine for U S A only Read and understand all instructions and warning la bels in the product doc...

Page 43: ...ry Additional labeling of the DR detector cradle Additional labeling of the DR detector dual battery charger Additional Labeling of the System Control Unit Additional Labeling of the Mini System Control Unit Additional Labeling of the System Control Unit Lite Consulting the About box XD 10 XD 10 Introduction to the DR Detector 43 0432A EN 20210426 1355 ...

Page 44: ...pe label on the back side of the DR detector DR Detector identification label Label Meaning 1 Writable label to identify and dedicate a DR Detector to an X ray system bucky 44 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 45: ...Additional labeling of the DR detector battery Type label on the back side of the battery XD 10 XD 10 Introduction to the DR Detector 45 0432A EN 20210426 1355 ...

Page 46: ...Additional labeling of the DR detector cradle Type label on the bottom side of the DR detector cradle 46 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 47: ...Additional labeling of the DR detector dual battery charger Type label on the bottom side of the DR detector dual battery charger XD 10 XD 10 Introduction to the DR Detector 47 0432A EN 20210426 1355 ...

Page 48: ...Additional Labeling of the System Control Unit Type label on the bottom side of the System Control Unit 48 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 49: ...Additional Labeling of the Mini System Control Unit Type label on the bottom side of the Mini Sys tem Control Unit XD 10 XD 10 Introduction to the DR Detector 49 0432A EN 20210426 1355 ...

Page 50: ...Additional Labeling of the System Control Unit Lite Type label on the bottom side of the System Control Unit Lite 50 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 51: ...w This will open the About box showing the current release and version details of the DR Retrofit solution Figure 12 DR Retrofit About box Displayed data may be different Note Always quote these details when you discuss any issues with Agfa service personnel 2 Click on the dialog to close it XD 10 XD 10 Introduction to the DR Detector 51 0432A EN 20210426 1355 ...

Page 52: ...utions should be extended to avoid potential contaminations and to avoid patients coming into close contact with the device The user is responsible for selecting a disinfection procedure Topics Cleaning Use of protective plastic bag Disinfecting Approved disinfectants Safety directions for disinfection 52 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 53: ...ON Make sure no liquid gets in the device CAUTION Clean the equipment with only a little moisture Do not spray disinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Liquids ingressing the DR Detector or the battery may cause malfunction and contamination Take special care near the battery bay and near the cable connector on the side of the DR De...

Page 54: ...etector must be wrapped in a protective plastic bag while performing the examination It is considered good clinical practice to use a single use protective bag in all cases where contact of the device or contaminants is expected to avoid contamination of others Make sure that the plastic bag is not wrinkled to avoid the creases showing in the image 54 XD 10 XD 10 Introduction to the DR Detector 04...

Page 55: ...ge the device UV disinfection is also not allowed Perform the procedure following the instructions for use the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital Items contaminated with blood or body fluids which may contain blood borne pathogens should be cleaned and then receive intermediate level disinfection with a product having an EP...

Page 56: ... disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device http www agfahealthcare com global en library overview jsp ID 41651138 56 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 57: ...s provided with the cleaning or disinfection product WARNING Consult the manufacturer s Material Safety Data Sheets MSDS and recommendations on the product label for additional information prior to use CAUTION Clean the equipment with only a little moisture Do not spray disinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Be sure that all surfa...

Page 58: ... is used safely and normally be sure to inspect the equipment before use If any problem is found during the inspection and cannot be corrected please contact your sales representative or local dealer Topics Daily inspection Half yearly inspection Regular Inspection and Maintenance Replacement Parts Support Repair 58 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 59: ... inlet and the AC outlet 3 Ensure that there are no loose screws or breaks Turn on the power Start the MUSICA Acquisition Workstation and perform a test exposure Half yearly inspection To indicate when the half yearly calibration is due a message is displayed on the MUSICA Acquisition Workstation Perform calibration half yearly or when exposure conditions have changed significantly For details ref...

Page 60: ...r sales representative or local dealer for regular inspections or maintenance CAUTION Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug its periphery and AC outlet with a dry cloth If the cord is kept plugged in for a long time in a dusty humid or sooty place dust around the plug will attract moisture This could cause insulati...

Page 61: ...upport Parts required to maintain the functioning of the product will be stocked for seven years after discontinuance of production to allow for repair XD 10 XD 10 Introduction to the DR Detector 61 0432A EN 20210426 1355 ...

Page 62: ...Repair The product can only be repaired in the factory 62 XD 10 XD 10 Introduction to the DR Detector 0432A EN 20210426 1355 ...

Page 63: ...the Customer Agfa reserves the right to revise these ISP Operating Environment Requirements and to make changes to them at any time Possible revisions of the ISP Operating Environment Requirements will only be available in an electronic form on request via our website by using the user documentation request form http www agfahealthcare com global en library index jsp The information presented here...

Page 64: ...es is limited only to authorized individuals and that physical theft of the device is prohibited An incident response plan detailing responsibilities and how to react and recover from incidents shall be in place Staff involved in the incident response plan shall be trained to respond appropriately and effectively A formal user provisioning and de provisioning process shall be implemented to enable...

Page 65: ...r 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 he...

Page 66: ...rts inside the equipment Also some disinfectants are flammable Take care when using them WARNING Do not connect the equipment with anything other than specified Doing so may result in fire or electric shock WARNING Never disassemble or modify the equipment Doing so may result in fire or electric shock Also since the equipment incorporates parts that may cause electric shock as well as other hazard...

Page 67: ...nd safety markings within this document and on the product CAUTION All Agfa medical products must be used by trained and qualified personnel CAUTION This device is not intended to supply heat to a patient However during normal use surfaces will become heated due to power dissipation Patient contact surfaces will not exceed 48 ºC under normal useconditions The operator should monitor and evaluate h...

Page 68: ...over resulting in injury to the user or patient or may flip over resulting in damage to the inner device CAUTION If a malfunction occurs do not use this device until qualified personnel correct the problem Should any of the following occur immediately turn OFF the power to each piece of equipment unplug the power cord from the AC outlet and contact your sales representative or local dealer When th...

Page 69: ...acts Typical flat field exposure settings are 75 kV 10 µGy large focus and using 1 5 mm Cu filter without grid CAUTION Damaged grid Reduced image quality Please handle the grids with special care Topics Safety directions for the power supply Safety directions for the System Control Unit Safety directions for the DR detector battery XD 10 XD 10 Introduction to the DR Detector 69 0432A EN 20210426 1...

Page 70: ...pment on cables and cords or do not pull bend bundle or step on them to prevent their sheath from being damaged and do not alter them neither Doing so may result in fire or electric shock WARNING Do not supply power to more than one piece of equipment using the same AC outlet Doing so may result in fire or electric shock WARNING Do not connect a multiple portable socket outlet or extension cord to...

Page 71: ...amaged resulting in fire or electric shock WARNING When using the power supply 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 device and that it is easily accessible in case of emergency CAUTION Position the power supply so that it is possible to disconnect it from the mains power if required XD 10 XD...

Page 72: ...with voltage and current according to the product specifications If power failures are frequent an uninterrupted power supply UPS should be installed to avoid loss of data CAUTION The System Control Unit and the X ray generator must be grounded to a common protective earth Always connect the three core power cord plug to a grounded AC power outlet 72 XD 10 XD 10 Introduction to the DR Detector 043...

Page 73: ...the plug fire or electric shock may result Stop charging the battery when the battery charger indicator lights keep indicating that the battery is charging beyond the specified charging time Not doing so may result in the battery overheating or smoking or in an explosion or fire Always check the remaining amount of the battery pack during use of the detector If performance of the battery pack has ...

Page 74: ... high humidity excessive dust or mechanical shock Otherwise battery leakage overheating or damage to the product may occur resulting in electrical shock burns injury or fire If the battery pack becomes heated or swollen immediately replace the battery with a new one before using it Otherwise overheat smoke explosion or fire may occur The Lithium ion polymer battery is recyclable Battery slowly dis...

Page 75: ...ting the DR detector Basic Workflow DR Detector Offline image acquisition workflow Guidelines for Pediatric Applications Stopping the DR detector Automatic exposure detection XD 10 XD 10 Getting started 75 0432A EN 20210426 1355 ...

Page 76: ...ous day Note The battery slowly discharges even if not in use The battery pack may have expired if it discharges immediately after being fully charged You can purchase a new battery pack to replace an exhausted one 4 Take the DR detector out of the cradle WARNING When taking the DR detector out of the cradle by lifting it upwards shock may be applied to the detector Always take the DR detector out...

Page 77: ...If the DR detector is configured in access point mode use the Windows wifi setting to connect the MUSICA Acquisition Workstation to the wireless network of the DR detector The DR detector is ready Before exposure make sure to check the equipment daily and confirm that it works properly Related Links Viewing the detector status on page 95 Managing network connections in client mode configuration on...

Page 78: ... the patient info Step 2 select the exposure Step 3 prepare the exposure Step 4 check the exposure settings Step 5 execute the exposure Step 6 perform a quality control Positioning the XD 10 XD 10 78 XD 10 XD 10 Getting started 0432A EN 20210426 1355 ...

Page 79: ...posed to unauthorized persons Step 2 select the exposure 1 At the MUSICA Acquisition Workstation select the thumbnail for the exposure in the Image Overview pane of the Examination window The selected DR detector is activated The DR Detector Switch shows the active DR detector and shows its status Flashing starting up Green constant ready for exposure 2 At the X ray generator console select the ex...

Page 80: ...tube with respect to the DR Detector and the patient 5 Set the correct distance between DR Detector and X Ray tube 6 Switch on the light on the collimator Adapt collimation if required Take care that the collimated area is not larger than the detector WARNING Monitor the patient position hands feet fingers etc with special care to avoid injury to the patient caused by unit movements Patient hands ...

Page 81: ...o error messages are displayed on the X ray system Exposure synchronization Depending on the configuration the DR Detector synchronizes to the exposure using one of these methods X ray generator synchronization Automatic exposure detection WARNING In a configuration using automatic exposure detection the X ray system allows executing an exposure even if the DR Detector is not ready Avoid unnecessa...

Page 82: ...control console lights up during exposure release WARNING Do not select another thumbnail until the preview image is visible in the active thumbnail At the MUSICA Acquisition Workstation The image is acquired from the DR detector and displayed in the thumbnail If collimation is applied the image is automatically cropped at the collimation borders 82 XD 10 XD 10 Getting started 0432A EN 20210426 13...

Page 83: ...S Picture Archiving and Communication System Connecting the MUSICA Acquisition Workstation to the hospital network If the DR detector is configured in access point mode use the Windows wifi setting to connect the MUSICA Acquisition Workstation to the hospital network to send images to the printer or to the PACS archive Related Links Switching between the wireless DR detector and the wireless hospi...

Page 84: ...ient orientation marker 1 3 2 Figure 17 Detector orientation aids 1 Tube side of the detector 2 Position of the sensor for automatic exposure detection 3 Location of the patient orientation marker The detector must be positioned with the patient orientation marker at the lower side of the region of interest The detector orientation and the patient orientation are exposure settings on the MUSICA Ac...

Page 85: ...ICA Acquisition Workstation is configured for a specific patient orientation either head left default or head right Depending on the design of the bucky the wired configuration may not support the use of the DR Detector in the bucky XD 10 XD 10 Getting started 85 0432A EN 20210426 1355 ...

Page 86: ... the demographic data and exposure timestamp for each image The user is responsible for assigning the right images to the right patient after finishing the offline image acquisition workflow WARNING Do not turn off the DR detector during the offline image acquisition workflow If the detector is turned off reconnect it to the MUSICA Acquisition Workstation The images that were already acquired will...

Page 87: ...ork connection between the DR detector and the MUSICA Acquisition Workstation is lost 5 Perform the exposures using the DR detector Wait at least 15 seconds between exposures The detector status display shows Send image while the detector is busy saving the acquired image The images are stored on the DR detector For each image write down the patient identification and the relevant image details ex...

Page 88: ...on in the worklist or select it from the drop down list in the title bar Sort the Worklist by patient name to see the examinations in chronological order The image is opened in the Examination window 9 Click the Edit button in the Image Detail pane to apply the correct image settings Check the notes that were made while acquiring the offline images to apply the correct image settings 10 Assign the...

Page 89: ... 13 Close the examinations that contain the acquired images Open the examinations one by one Perform quality control If all images in the examination are OK click Close and Send All Recovery examinations appear as open examinations If the maximum number of open examinations is exceeded transferring a recovery image to a worklist entry will fail To solve this first close the recovery examinations c...

Page 90: ... such as bean bags and restraint systems foam wedges adhesive tapes etc to avoid the need of repeating exposures due to the movement of the pediatric patients Whenever possible use techniques based on the lowest exposure times Shielding We recommend you provide extra shielding of radiosensitive organs or tissues such as eyes gonads and thyroid glands Applying a correct collimation will help to pro...

Page 91: ...ild reducing tube output kVp and mAs limiting the duration of dynamic imaging Try to use always short exposure times large SID values and immobilizing devices Avoid multiple scans and use alternative diagnostic studies such as ultrasound or MRI when possible XD 10 XD 10 Getting started 91 0432A EN 20210426 1355 ...

Page 92: ...the detector in an empty slot of the DR detector cradle to charge the battery Insert the DR detector with the tube side to the right The status indicator for the slot in which the detector is inserted lights up yellow The battery is charging Note When the detector will not be used for some time remove the battery Otherwise overdischarge may occur leading to a shorter battery life Note When not in ...

Page 93: ... area Positioning the sensor for automatic exposure detection outside the exposed area can cause failure to trigger the image acquisition WARNING Very short exposure time can cause failure to trigger the image acquisition Use an exposure time of at least 3 ms WARNING Specific exposure conditions use of grid thickness of the exposed object can cause failure to trigger the image acquisition or horiz...

Page 94: ...e detector status Charging a battery Replacing the battery Managing network connections in client mode configuration Managing network connections in access point mode configuration 94 XD 10 XD 10 Advanced Operating 0432A EN 20210426 1355 ...

Page 95: ...splay 1 Press the power button for about 1 second The status display turns on and shows the status of the DR detector Battery status Connection status 2 Press the power button again The status display shows the IP address of the DR detector 3 Press the power button again The status display shows the SSID name used by the DR detector The status display is turned off automatically after 60 seconds T...

Page 96: ...charge level is less than 5 The battery is being charged The bar inside the battery icon repre sents the current charge level The battery is in use The bar inside the battery icon represents the current charge level 96 XD 10 XD 10 Advanced Operating 0432A EN 20210426 1355 ...

Page 97: ...ntifier Default Sy if not using Preset switching Wifi connection status is very good Wifi connection status is good Wifi connection status is normal Wifi connection status is bad Wifi connection status is very bad DR detector is disconnected Table 5 The DR detector is connected via the DR detector cable Wired DR detector connection speed 1 Gbps Wired DR detector connection speed below 100 Mbps XD ...

Page 98: ...in an empty slot of the DR detector dual battery charger The charge level of the battery is monitored and it is kept at maximum level until the battery is removed from the battery charger Related Links Safety directions for the DR detector battery on page 73 Safety directions for the power supply on page 70 Topics Charging the DR detector in the DR detector cradle Charging the DR detector using th...

Page 99: ... side facing right 2 Insert the DR detector in an empty slot of the DR detector cradle Figure 21 Inserting the DR detector in the DR detector cradle The corresponding status indicator lights up orange to indicate that the battery is charging When the battery is fully charged the status indicator light turns green Related Links DR detector cradle on page 21 XD 10 XD 10 Advanced Operating 99 0432A E...

Page 100: ...he wall socket 2 Connect the USB Type C cable to the connector on the DR detector 1 2 1 Battery status indicator 2 Connector for power adapter USB Type C Figure 22 Connector for power adapter USB Type C The battery status indicator lights up orange to indicate that the battery is charging 3 When the DR detector is turned on the battery status can be read from the status display When the battery is...

Page 101: ...r The battery status can be read from the DR Detector Switch on the MUSICA Acquisition Workstation While charging the DR detector can still be used The DR detector can also be used with the DR detector cable connected without a battery Related Links DR detector cable on page 25 XD 10 XD 10 Advanced Operating 101 0432A EN 20210426 1355 ...

Page 102: ...ultaneously 1 Insert a battery in an empty slot of the battery charger 1 1 2 2 Figure 23 Inserting the battery in the battery charger The corresponding status indicator lights up orange to indicate that the battery is charging 2 Remove the battery when the status indicator for the slot turns green 102 XD 10 XD 10 Advanced Operating 0432A EN 20210426 1355 ...

Page 103: ...ver to loosen the knobs that secure the battery cover plate Turn the knobs counterclockwise a quarter turn 3 Take off the cover plate 4 Remove the battery 5 Insert the fresh battery Make sure that the orientation of the battery is correct so that the electrical contacts of the battery connect to the electrical contacts of the DR detector 6 Put the cover plate in place 7 Use the flat head screwdriv...

Page 104: ...on Workstation 2 Press and hold the AP mode button for 3 seconds Figure 25 AP mode button The detector status display shows AP scan indicating that the wireless network is being scanned From a list of access points that is configured upon installation the one with the highest signal strength is automatically selected After a while the detector display shows Change AP Note that if the DR detector w...

Page 105: ...he AP mode button for 1 second to display the SSID name of the access point to which the DR detector is connected Related Links Configuration on page 14 XD 10 XD 10 Advanced Operating 105 0432A EN 20210426 1355 ...

Page 106: ...ting as an access point The user must manually switch the wireless connection between the hospital network and the DR detector Additionally the DR detector can be switched to client mode The detector can be configured upon installation with another MUSICA Acquisition Workstation with access point or System Control Unit to which it will connect in this status Topics Switching between the wireless D...

Page 107: ... network and the wireless connection to the DR detector WARNING If the network connection is interrupted the MUSICA Acquisition Workstation may reconnect to different access point if the option Connect automatically in the Windows wifi settings is enabled Do not enable the option Connect automatically when connecting to the hospital network or to a DR detector To switch between wireless networks 1...

Page 108: ... communication to the DR Detector is possible no exposures can be performed To connect to the wireless DR Detector select the name of the detector The MUSICA Acquisition Workstation is connected to the DR Detector to make exposures No communication to the hospital network is possible e g to RIS or PACS 4 Touch the Connect button The network connection is switched to the selected wireless network R...

Page 109: ... Press and hold the AP mode button for 3 seconds Figure 29 AP mode button The detector status display shows STA Mode Start indicating that the client mode is being activated 3 Wait until the connection to the MUSICA Acquisition Workstation is established The detector status display shows the signal strength 4 Perform the examinations 5 To return the DR detector to access point mode press and hold ...

Page 110: ...rk or to a DR detector To connect the MUSICA Acquisition Workstation to another DR detector 1 On the MUSICA Acquisition Workstation swipe in from the right side of the screen The Windows action center is displayed Wi Fi Hospital Network DR Detector 1 DR Detector 2 Figure 30 Windows action center with Wifi button highlighted 2 Touch the Wifi button The available wireless networks are displayed 3 Se...

Page 111: ...ready for exposure The MUSICA Acquisition Workstation is connected to the DR detector but the DR detector is not active access point mode Images are not sent to the printer or to the PACS archive Identifying problems XD 10 XD 10 Problem solving 111 0432A EN 20210426 1355 ...

Page 112: ...d by a DR Detector Cause Exposure conditions have changed significantly since latest calibration Brief Solution Perform calibration of the DR Detector For details refer to the DR Detector Calibration Key User Manual document 0134 112 XD 10 XD 10 Problem solving 0432A EN 20210426 1355 ...

Page 113: ...point mode The AP mode button has been pushed accidentally Brief Solution Check the detector status display If the DR detector is in client mode the connec tion status is displayed If the DR detector is in access point mode the ac cess point icon is displayed If the status does not match the way it should com municate to the workstation press and hold the AP mode button for 3 seconds The DR detect...

Page 114: ...n page 95 Connecting to another MUSICA Acquisition Workstation client mode on page 104 Switching between the wireless DR detector and the wireless hospital network on page 107 Switching temporarily to client mode on page 109 Connecting the MUSICA Acquisition Workstation to another DR detector access point mode on page 110 114 XD 10 XD 10 Problem solving 0432A EN 20210426 1355 ...

Page 115: ... that the MUSICA Acquisition Worksta tion is connected to the DR detctor but the DR Detector Switch shows an error status for the DR detector Cause Another MUSICA Acquisition Workstation is still connected to the DR detector Brief Sol ution On the other MUSICA Acquisition Workstation switch to the wireless hospital network to disconnect from the DR detector XD 10 XD 10 Problem solving 115 0432A EN...

Page 116: ... The MUSICA Acquisition Workstation has not been connected to the hospital network Brief solution Use the Windows wifi setting to connect the MUSICA Acquisition Workstation to the hospital network The images will be sent automatically as soon as a connection to the hospital network is active Related Links Switching between the wireless DR detector and the wireless hospital network on page 107 116 ...

Page 117: ...ly charge the battery pack The battery pack is broken Replace the battery pack The status indicator of the System Control Unit does not light up The power cord is unplugged from the AC out let Connect the plug to the AC outlet firmly If it still does not work replace the System Con trol Unit The status indicator of the System Control Unit does not light up in green A hardware error has occurred Tu...

Page 118: ...or used in low tempera tures In low temperatures the bat tery capacity decreases Use a battery charged in normal temperatures The battery bay is unusu ally hot The battery is malfunctioning Stop using the battery and consult your sales representa tive or local dealer 118 XD 10 XD 10 Problem solving 0432A EN 20210426 1355 ...

Page 119: ...data DR detector battery technical data DR detector cradle technical data DR detector dual battery charger technical data System Control Unit Mini System Control Unit System Control Unit Lite XD 10 XD 10 Technical Data 119 0432A EN 20210426 1355 ...

Page 120: ...adapter with USB Type C cable DC 18 V max 2 78 A Power consumption max 15 W max 50 W while battery is charging Operating time early in the battery life 7 hours image acquisition each 100 sec onds 8 hours standby Network connection Wireless connection IEEE 802 11n ac 2 4 GHz 5 GHz Environmental conditions during normal operation Room temperature between 0 C and 40 C Humidity non condensing between ...

Page 121: ...r the whole detector surface Vibration tolerance 2 G during normal operation 5G during storage and transport Shock tolerance 20 G during normal operation 30 G during storage and transport Drop limit 1000 mm once Image acquisition Image acquisition time mini mum cycle time 4 s Conversion screen CsI Pixel size 124 µm Active pixel matrix 2048 x 2560 Effective pixel matrix 2024 x 2536 Detector type am...

Page 122: ...imensions length x width x height 189 0 mm x 89 0 mm x 6 65 mm Weight 185 g Battery output Output voltage DC 11 55 V Capacity 3400 mAh Lifecycle Preventive maintenance frequen cy No preventive maintenance required Estimated product life Estimated product life 800 charge cy cles 122 XD 10 XD 10 Technical Data 0432A EN 20210426 1355 ...

Page 123: ...ultaneous charging 2 detectors Dimensions Dimensions width x height x depth 410 0 mm x 159 0 mm x 168 0 mm Weight 4040 g Electrical connection Rated Power Supply DC 24V 2 A max Lifecycle Preventive maintenance frequency No preventive maintenance required XD 10 XD 10 Technical Data 123 0432A EN 20210426 1355 ...

Page 124: ...ber FXRC 04A Simultaneous charging 2 batteries Dimensions Dimensions length width height 304 0 mm 230 0 mm 15 5 mm Electrical connection Rated power supply DC 24 V 3 33 A max Lifecycle Preventive maintenance frequency No preventive maintenance required 124 XD 10 XD 10 Technical Data 0432A EN 20210426 1355 ...

Page 125: ...C100 to 240V 50 60 Max 2 0 0 8A Rated power supply output DC 24V 3 25A 78W Wireless connection IEEE 802 11n 2 4 GHz 5 GHz Dimensions width x height x depth 300 mm x 236 mm x 58 mm 140 mm antenna height Weight 2 8 kg XD 10 XD 10 Technical Data 125 0432A EN 20210426 1355 ...

Page 126: ...RS 04A Rated power supply input DC 24V 2A max Wireless connection IEEE 802 11n 2 4 GHz 5 GHz Dimensions width x height x depth 210 mm x 170 mm x 45 mm 140 mm antenna height Weight 1 2 kg 126 XD 10 XD 10 Technical Data 0432A EN 20210426 1355 ...

Page 127: ... Control Unit Lite Part number FXRP 02A Rated power supply input DC 24V 1A max Dimensions width x height x depth 109 mm x 108 mm x 29 5 mm Weight 0 33 kg XD 10 XD 10 Technical Data 127 0432A EN 20210426 1355 ...

Page 128: ...HF emission and immunity Topics EMC Electromagnetic Compatibility Statements Electromagnetic emissions Electromagnetic immunity For U S A 128 XD 10 XD 10 Remarks for HF emission and immunity 0432A EN 20210426 1355 ...

Page 129: ...between electrical devices to prevent malfunction WARNING Obtaining diagnostic images and transferring them to a PC workstation are the essential performance of the DR detector If the required performance is degraded or lost due to electromagnetic interference images that are not suitable for diagnosis may be obtained or the image may be lost XD 10 XD 10 Remarks for HF emission and immunity 129 04...

Page 130: ... low voltage power supply network and can be used in all facilities except the ones that sup ply voltage to home facilities or buildings The emissions charac teristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential envi ronment for which CISPR 11 class B is normally required this equipment might not offer ade quate prote...

Page 131: ...typical commer cial or clinical envi ronment Impulse voltages surges in accord ance with IEC 61000 4 5 1 kV push pull voltage 2 kV com mon mode voltage 1 kV push pull voltage 2 kV com mon mode voltage The quality of the voltage supplied should correspond to that of a typical commercial or clini cal environment Voltage break throughs short term interruptions and variations in the voltage supplied i...

Page 132: ...iables in accord ance with IEC 61000 4 6 3 Veff 150 kHz to 80 MHz 6 Veff in the ISM bands 150 KHz to 80 MHz 3 Veff 150 kHz to 80 MHz 6 Veff in the ISM bands 150 KHz to 80 MHz The electromagnetic field strength of a stationary RF trans mitter determined by an electromagnetic test survey must be less than the compli ance level of each frequency range Radiated high fre quency disturbance variables in...

Page 133: ... in the location in which this device is used exceeds the applicable RF compli ance level above this device should be observed to verify normal operation If abnormal performance is observed ad ditional measures may be necessary such as re orienting or relocating this device WARNING The field strength will be lower than 3 V m above the fre quency range from 150 kHz to 80 MHz WARNING Portable RF com...

Page 134: ... may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measure Reorient or...

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