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About the Allura Xper FD20 series

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1. Isokerma map at 150 cm 59 10 inch height 0 04 0 02 0 08 0 04 0 08 Technical data 7 17 7 2 Stray radiation 7 18 Technical data Normalized isokerma map at 1 m 39 37 in above floor for Allura Xper FD20 20 stand lateral position Technique factors Fluoroscopy 120kV no additional filter New picture here showing isokerma mappimg for FD20 20 system Figure 7 6 Isokerma map at 100 cm 39 37 inch height ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Stray radiation 7 2 ALLURA XPER FD20 SERIES Normalized isokerma map at 1 5 m 59 10 in above floor for Allura Xper FD20 20 stand lateral position Technique factors Fluoroscopy 120kV no additional filter New picture here showing isokerma mappimg for FD20 20 system Figure 7 7 lsokerma map at 150 cm 59 10 inch height Document version 3 0 Technical data 7 19 7 2 Stray radiation 7 20 Technical data Influence of additional filtering on isokerma maps The isokerma maps in Figure 7 4 through Figure 7 7 present the normalized stray radiation data if no additional filter is applied The following table presents the normalized AK values as percentage of the curves as function of the additional filter selection for filter selection see section 2 8 Radiation safety Additional filter used Percentage of normal
2. fou eee atm sms Qw 120 lnmtendedaise 1 82 KorpatibIIty oo o oot td a t 16 Contra indications MV D S 1 8 Other 5 00 2 00 00000000 000 Introduction Introduction 1 2 ALLURA XPER FD20 series Document uersion 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA FD20 series Document version 3 0 Introduction About the Allura Xper FD20 series I he Allura Xper FD20 serles used for dia nostic ar id interventional vascular procedures consists of Allura FD20 monoplane with ceiling suspended frontal stand Allura Xper FD20 monoplane with a floor mounted frontal stand Allura Xper FD20 10 biplane with ceiling suspended Lateral and floor mounted frontal stand Allura Xper FD20 20 biplane with ceiling suspended Lateral ARC N and a floor mounted frontal stand Introduction 1 3 1 2 About these Instructions for Use Referencel Frontal Frontal monitor Examination monitor Colour monitor s ateral option Examination monitor Reference 2 Lateral monitor Lateral ARC Xper module Frontal and stand viewpad Xper Patient geometry support and imaging modules Foot switches New picture here with FD20 on the Lateral ARC N Figure 1 1 General system components in the examination
3. FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems EMC compliance 8 4 ALLURA XPER FD20 SERIES NOTE 8 4 Document version 3 0 Patient Environment Any volume space in which intentional or unintentional contact between patient and parts of the System or some other persons touching parts of the System can occur Multiple portable socket outlet combination of two or more socket outlets intended to be connected to integral with flexible cables or cords and which can easily be moved from one place to the other while connected to the supply A multiple portable socket outlet may be a separate item or an integral part of medical or non medical equipment EMC compliance The Allura Xper systems are intended for use in the electromagnetic environment specified below The customer or the user of the Allura Xper systems should ensure that they are used in such an environment Electromagnetic emissions Guidance and manufacturers s declaration electromagnetic emissions Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Allura Xper systems use RF energy only for CISPR 11 their internal functions Therefore their RF emissions are low and not likely to cause any interference in nearby electronic equipment RF emissions Class A The Allura Xper systems are suitable for use in CISPR 11 all estab
4. 4 6 System and error messages Displayed Message Frontal stand not in working position frontal X ray disabled Geometry module control room not operable Geometry module examination room not operable Geometry problem Reselect procedure Illegal centerline normals file using defaults Illegal format in normals file Illegal radial normals file using defaults Illegal regional normals file using defaults Illegal slager normals file using defaults Image disk error deselect fluo subtract mode Image disk full deselect fluo subtract mode Image in other plane is not yet calibrated Imaging module control room not operable Imaging module examination room not operable Incorrect library detected Initialization error Injector not ready arm injector Injector unavailable reselect procedure Internal error Invalid application please select another application ALLURA XPER FD20 SERIES Action Meaning The frontal geo stand is not in working position Call service Call service A Geometry problem that can only be solved by starting the procedure from scratch The file containing the values of healthy people is corrupt The format of the normals file is incorrect The file containing the values of healthy people is corrupt The file containing the values of healthy people is corrupt The file containing the values of healthy people is corrupt Fluoroscopy disable due to im
5. defined time Unable to link the PNG file to data base As Examination folder deleted Call service Rotational scan time too short An error occurred during parsing of the report definition file e Run aborted tube overload limit Exposure disabled due to overloaded X ray tube Select procedure to continue Select Smart Mask not possible The Slager wall motion analysis cannot be computed Call service System and error messages 4 1 Message and error handling 4 10 System and error messages Displayed Message System failure Target position NOT reached The correction drawn is too short The correction is too short The printer door is not closed The requested film type is not available The requested number of copies is not supported Transfer close exam failed try again Transfer communication error Transfer configuration error Transfer invalid data try to restart job Transfer system failure try to restart job TUBE Bodyguard Override Tube overload Tube overloading please finish run Unknown projection please select another image WARNING Adjustment of frontal stand required Action Meaning Error in database For whatever reason the APC stand movement has not reached its targetposition Not enough points to complete a correction Internally a line is presented as an array of points between start and end of the drawn correction When there are not enough poin
6. Point of Interest Point of Interest Height Point of Interest Lateral Offset Figure 8 5 Point Of Interest and Beam IsoCenter and tiltangle 8 24 Appendices ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA XPER FD20 SERIES Table Height Document version 3 0 Table Height The Table Height is the height relative to the floor of the longitudinal centerline of the tabletop below the Beam IsoCenter When the tabletop is floated lateral or longitudinal the Table Height does not change But when the tabletop is tilted non IsoCentric or cradled the Table Height changes 27 71 E Figure 8 6 Definition of Table Height in relation to tilted table Appendices 8 25 8 3 Glossary Beam gt p Table Height Table Height 777 Tabletop M Longitudinal ES lateral Centerline aa Tabletop i Tabletop lateral 8 26 Table Base DR mam Figure 8 7 Definition of Table Height in relation to cradled table Default Point Of Interest POI When e g a new patient is selected the system will use a default Point Of Interest POI as long as the operator has not defined a new Point Of Interest when Store Iso Center is pressed The default Point Of Interest is defined
7. Radiation safety Operators are strongly urged to acquaint themselves with the current recommendations of the International Commission on Radiological Protection and in the United States with those of the US National Council for Radiological Protection ICRP Pergamon Press Oxford New York Beijing Frankfurt Sao Paulo Sydney Tokyo Toronto NCRP Suite 800 7910 Woodmont Avenue Bethesda Maryland 20814 USA The X ray equipment is intended for procedures in which the Air Kerma AK levels can be high enough during normal use to constitute a risk of deterministic effects Full use must be made of all the equipment s radiation protection features and of all radiation protection devices accessories systems and procedures available to you as the operator Information about radiation protection devices and their uses can be found in the Allura Xper FD system Accessories Instructions for Use A Do not attempt to remove modify override or frustrate any safety device on the equipment If you do interfere with safety devices this could lead to serious or fatal injury Use only the prescribed Air Kerma Rate AK R necessary to perform a particular examination or treatment Radiation guidelines Always apply the following rules when using radiation equipment never radiate unless absolutely necessary radiate for as short a time as possible when possible use automatic AKR control stay as far
8. 6 fold 180 1424 x 1150 x 524 Technical data 7 5 7 1 Specifications 7 6 Technical data 7 1 7 7 1 8 7 1 9 Movement range Type Longitudinal mm Lateral mm Vertical mm Ceiling height 2900 mm 2 fold ca 3600 ca 3000 520 mono plane only 3 fold ca 3600 ca 3000 520 mono plane only 4 fold ca 3600 ca 3000 320 6 fold ca 3600 ca 3000 320 Actuator Mains voltage 230 V Mains frequency 50 60 Hz Maximum power consumption 500 W Maximum speed 12 mm s 0 5 in s Examination light Light intensity 30 000 Lux Colour temperature 4300 K Colour rendering index Ra 96 Focusable light field size 14 25 cm 5 5 9 8 inch Working distance 70 140 cm 27 6 55 1 inch Light intensity at 30 000 Lux 114 W m Lamp type halogen 22 8 24 V 50 W Mains power 220 240 V Automatic wedge filter One or two semi transparent wedge shaped filters automatically or manually adjusted to the projector Imaging chain per channel Frontal channel 30 x 40 cm 12 x 16 inch six mode Flat Detector subsystem 7 input fields with the following image format field of view sizes are available at all SID positions 48 cm 19 inch 42 cm 17 inch 31 12 inch ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Specifications 7 1 26 cm 10 inch 22
9. Figure8 8 Default Point Of Interest Appendices 8 27 8 3 Glossary 8 28 Appendices IEC Definitions The definitions listed below have been extracted from the following IEC standards 60601 1 Medical electrical equipment Part 1 general requirements for safety IEC 60601 1 1 Medical electrical equipment Part 1 General requirements for safety 1 Collateral standard Safety requirements for medical electrical systems Functional Other connection equipment Allura Xper equipment Mains power Mains power supply supply Medical electrical equipment Equipment Electrical equipment provided with not more than one connection to a particular mains supply and intended to diagnose treat or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and or transfers energy to or from the patient and or detects energy transfers to or from the patient Equipment includes those accessories as defined by the manufacturer which are necessary to enable the normal use of the equipment Functional connection Any connection electrical or otherwise including those intended to transfer signals and or power and or substances Medical Electrical System System combination of items of equipment at least one of which must be medical electrical equipment and interconnected by functional connection or by use of a multiple portable socket outlet ALLURA
10. 1 0 mm 2 0 4 mm Cu 1 0 mm AI 3 0 9 mm Cu 1 0 mm AI x any digit 0 to 9 For information on stray radiation refer to 7 Technical data Dosimeter calibration Refer to the instructions specified in the Service Manual Filtration in mm Al eq at 75 kV 4 0 11 0 21 5 Safety 2 11 2 9 Network safety security and privacy 2 12 Safety 2 9 Network safety security and privacy Customer Role in the Product Security Partnership We recognize that the security of Philips Medical Systems products is an important part of your facility s security indepth strategy However these benefits can only be realized if you implement a comprehensive multi layered strategy including policies processes and technologies to protect information and systems from external and internal threats Following industry standard practice your strategy should address physical security operational security procedural security risk management security policies and contingency planning The practical implementation of technical security elements varies by site and may employ a number of technologies including firewalls virus scanning software authentication technologies etc As with any computer based system protection must be provided such that firewalls and or other security devices are in place between the medical system and any externally accessible systems The USA Veterans Administration has developed a wid
11. 1960 x 2480 image matrix at 14 bits depth for the largest mode Acquisition speed 0 5 1 2 8 4 and 6 fps standard and 15 and 30 fps optional image resolution up to 1960 x 2048 pixels for vascular biplane imaging e Fluoroscopy speed 3 125 6 25 12 5 frames per second at 1024 x 1024 Geometrical fill factor per channel The geometrical fill factor is the fraction of the pixel area sensitive to the incoming signal which can be divided into two parts The geometrical fill factor of the photodiode also called optical fill factor is 6996 The geometrical fill factor of the scintillator also called X ray fill factor is 10090 due to a continuous scintillator Quantum limited performance The operation range of the sensor is specified to be operated with system doses between 10nGy and 4300nGy at a maximum speed of 30 frames per second Within this range the device is operated quantum limited Beam carriers Frontal channel floor mounted C arm stand Rotation speed 0 25 s variable these speeds are only valid when the stand is in its working position otherwise the maximum speed is 8 s Angulation speed 0 25 s variable these speeds are only valid when the stand is in its working position otherwise the maximum speed is 8 s Projection angles see table below C arm position Angulation degrees Rotation degrees Head end of table 90 caudal to 90 cranial 120 LAO to 185 RAO ALL
12. 2 1 ALLURA FD20 series Document version 3 0 Safety Important safety directions Philips Medical Systems products are all designed to meet stringent safety standards However all medical electrical equipment requires proper installation operation and maintenance particularly with regard to human safety It is vital that you read note and where applicable strictly observe all DANGER notices and safety markings on the Allura Xper FD20 series equipment It is vital that you follow strictly all safety directions under the heading SAFETY and all WARNINGS and CAUTIONS throughout this manual to help ensure the safety of both patients and operators In particular you must read understand and know the Emergency procedures described in this Safety section before attempting to use the equipment for any patient examination You should also note the following information given in the Introduction section of this manual 1 4 Intended use 1 6 Contra indications 1 7 Training Only qualified and authorized personnel may operate this equipment In this context qualified means those legally permitted to operate this type of medical electrical equipment in the jurisdiction s in which the equipment is being used and authorized means those authorized by the user of the equipment Personnel operating the equipment and personnel in the examination room must observe all laws and r
13. 5 12 Maintenance If a spray has been used the operator must be satisfied that all traces of the vapour have dispersed before switching the equipment on again Disinfection techniques for both the equipment and the room must comply with all applicable laws and regulations which have the force of law within the jurisdiction in which the equipment is located ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 3 0 Product disposal 6 1 6 2 6 3 6 4 Mirror rra NM pM ORT 6 3 Passing the Allura FD20 series system on to another user 6 3 Final disposal of the Allura Xper FD20 series system 6 4 Fitting removing and disposing of batteries 6 5 6 4 1 Battery replacement for remote control 6 5 Product disposal 6 1 Product disposal 6 2 Product disposal ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 6 1 6 2 Document version 3 0 Product disposal Introduction Philips Medical Systems is concerned to help protect the natural environment and to help ensure continued safe and effective use of the Allura Xper FD20 series system through proper support maintenance and training Philips equipm
14. Dead mans principle All movement controls must be kept activated by the operator to start and continue a motorized movement Releasing the control stops the movement degree of run out must be taken into account depending on the speed of the movement Appendices 8 11 8 2 Safety devices for the stand and table movements 8 12 WARNINGS Appendices WARNING BodyGuards A BodyGuard is not a switch device but a device that senses distance and controls the maximum permitted speed of the movement All motorized movements of the C arm and table are controlled by the BodyGuard system The system will protect the patient by slowing down movement speeds when an object is detected within a certain safety distance The detection system does not prevent all collisions but due to the reduced movement speeds these collisions will not be harmful if they occur During execution of a rotational scan all BodyGuard sensors are switched off BodyGuard sensors are switched off when the Smart BodyGuard override function is active Biosense amp compatibility When the Biosense Electro Physiology system is applied in combination with the Allura Xper FD20 series system the Biosense coil mounted under the tabletop interferes with the Allura system in the following ways When the Biosense coil is activated it will impair the normal operation of the X ray tube cover BodyGuard sensor on the frontal stand such tha
15. Receptor Correction Source Skin Distance IEC The Source Skin Distance IEC is used to calculate and display the skin dose applied to the patient according to the IEC legal standards The Source Skin Distance IEC is the distance from the Focal Spot of the X ray source to the Interventional Reference Point The Source Skin Distance IEC is a fixed value which is 61 5 cm for the PolyG2 and 66 cm for the Clea Appendices 8 21 8 3 Glossary 8 22 Appendices Beam IsoCenter Interventional Reference Point Focal Spot Figure 8 3 Some reference points of the X ray beam in frontal and lateral stand Patient Space The Patient Space is the distance from the Beam IsoCenter to the surface of the Image Detector as determined by the edges of the detector see Figure 8 4 The maximum Patient Space is an indication of the maximum patient thickness that allows 3 DRA ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA FD20 series Document version 3 0 X ray sensitive layer Maximum patient Anti scatter grid space Mechanical surface of Receptor correction Image Detector Figure 8 4 Layout of Image Detector and anti scatter grid Receptor Correction The Receptor Correction is the distance between the mechanical surface of the Image Detector without anti scatter grid and the X ray
16. 0 System and error messages Message and error handling If a warning or error is detected a message is displayed in the operator guidance message area 12 on the Reference monitor and in the Guidance message area 2 of the AGD on the Data monitor Messages are displayed at the moment the error occurs and for as long as the error conditions remain If more than one error is detected the message relating to the error with the highest priority is displayed If an action type message is displayed the system cannot be used If a warning type message is displayed the system can be used with reduced performance Some messages relate to a specific channel frontal lateral and are only displayed on the associated monitor For certain errors the system will reset automatically Contact Service if automatic resets occur frequently Error messages The following table shows all error and warning messages valid for the Allura Xper FD20 series system Displayed Message An error occurred No further details available An invalid heart rate has been entered An invalid height has been entered An invalid weight has been entered Button active Release button to complete startup Centerline wall motion can not be computed Action Meaning Unknown error The heartrate entered was negative or not within the acceptable range The height entered was negative or not within the acceptable range The weight enter
17. 9 inch 19 cm 7 5 inch 15 cm inch FD rotation 90 Time to rotate from portrait to landscape and vice versa 3 sec Maximum rotation speed 45 sec Pixel size 154 x 154 um Detective Quantum Efficiency DQE gt 73 at low spatial frequencies Spatial resolution properties MTF 1 0 Ip mm 26076 2 0 Ip mm 23076 nyquist 21576 Dynamic range linear within 296 up to 4300nGy Output digital video 1960 x 2480 image matrix at 14 bits depth for the largest mode Acquisition speed 0 5 1 2 3 4 and 6 fps standard and 15 30 50 and 60 fps optional image resolution up to 1960 x 2048 pixels for vascular monoplane imaging Fluoroscopy speed 3 75 7 5 15 and 30 frames per second at 1024 x 1024 Lateral channel 30 x 30 cm 12 x 12 inch triple mode Flat Detector subsystem 6 input fields with the following image format field of view sizes are available at all SID positions 42 cm 17 inch 31 cm 12 inch 26 cm 10 inch 22 9 inch 19 cm 7 5 inch 15 6 inch Pixel size 154 x 154 um Detective Quantum Efficiency DQE gt 73 at low spatial frequencies Spatial resolution properties ALLURA FD20 series Document version 3 0 Technical data 7 7 7 1 Specifications 7 8 Technical data 7 1 10 MTF 1 0 Ip mm 26076 2 0 Ip mm 23076 nyquist 21576 Dynamic range linear within 296 up to 4300nGy Output digital video
18. AV HV and EH X30 GND at pcb DIG kV mA where 1 V equals 20 kVp Tube current during continuous fluoroscopy Measured with a digital mA meter connected instead of the mAs plug onto EG 100 The measured mA value must be corrected by subtracting the current flowing via the measuring divider resistor by the following expression I kV 2xR where the value R of the divider resistor is equal to 100Mohms for non GS tubes and 70Mohms for GS tubes divider resistor divider resistor Tube current during radiography and cine fluoroscopy The peak value of the tube current is measured with an oscilloscope connected via a RC filter onto EG 100 mAs plug and GND Figure 11 1 where 1 V equals 200 mA The measured value has to be corrected by subtracting the current flowing via the measuring divider resistor by the following expression I kV 2xR where the value R of the divider resistor is equal to 100Mohms for non GS tubes and 70Mohms for GS tubes divider resistor divider resistor ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Standards and regulations 8 1 ALLURA FD20 series Document version 3 0 Tube current during pulsed fluoroscopy The peak value of the tube current is measured with an oscilloscope connected via a RC filter onto EG 100 mAs plug and GND Figure 11 1 where 1 V equals 200 mA The measured val
19. Invalid accession number and or request id Invalid combination of PatientlD AccNr and RequestlD n a Job failed The examination folder was deleted Lateral stand longitudinal position is not parked Lateral stand must be moved to the parkposition first Lateral stand longitudinal position is inbetween Lateral stand must be moved to workarea or to the parkposition first No license key found The Longitudinal movement is not available FDPA is not possible n a Maximum number of images in report reached Monoplane fluoroscopy mask Biplane fluoroscopy not possible n a n a n a n a n a Displayed when no SID SOD can be found System and error messages 4 17 4 1 Message and error handling 4 18 System and error messages Displayed Message No more save positions overwriting last save No Name No name supplied for new patient No standard image used for input Number of average calibrations exceeds maximum Parallel angle lines not allowed Park LArc prior to start Bolus Chase Park LArc prior to start Rotation scan Park LArc prior to start Rotation scan Patient name part too long Performed step 26115 of the calibration Pixel size is out of limits Please move table out of the XrayBeam and press footswitch Please press exposure footswitch Please release footswitch Please wait Position table at start position Preferences file is corrupt Press speed contr
20. Rot Angulation CAUD Ang CRAN Ang Appendices 8 19 8 3 Glossary 8 20 Appendices RAO 90 CRAN 607 CRAN 90 5 8 RAO 135 CRAN 607 180 CRAN 60 180 CRAN 30 7 09 detector C AUD 30 0 CRAN 60 I 4045 gt angulation RAD 90 CRAN 30 lines RAO 90 0 RAD 90 CAUD 309 RAD 90 C AUD 60 rotation lines 7 RAD 135 CAUD 305 RAO 135 CRAN 30 RAO 1357 07 180 Figure 8 2 Angle information When the L arm is in the head position rotation and angulation of the X ray beam always results in a detector movement across either a rotation or angulation line Therefore only one angle is changing When the L arm is not in the head position and the angulation is not 0 then a rotation of the X ray beam always results in the detector crossing both rotation and angulation lines Also if rotation is not 0 180 then angulation of the X ray beam always results in the detector crossing both angulation and rotation lines Therefore both angles are changing Patient and beam positioning Source Image Distance SID The SID is the distance from the Focal Spot of the X ray source to the X ray sensitive layer in the image detector in the center of the detector The accuracy of the SID is 1 mm see Figure 8 3 Source Object Distance SOD The SOD whi
21. an insecure network The user should provide some level of network protection e g installing firewalls Implementation In order to meet the requirements described above the Allura Xper FD20 series implements the solution defined by the Integrating the Healthcare Enterprise IHE year 4 Basic Security profile The Basic Security Integration Profile establishes security measures which together with the Security Policy and Procedures of the Enterprise provide patient information confidentiality data integrity and user accountability The following IHE roles can be identified within the Allura Xper FD20 series system modality image creation image display secure node ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Standards and regulations 8 1 ALLURA FD20 series Document version 3 0 In order to fulfil these roles and to implement the Basic Security Profile the Allura Xper FD20 series system must be able to generate messages relating to security and networking related changes made via Field Service system starting and shutdown the system plays a part in a number of IHE roles as detailed above It will not however generate a message for the start up of each activity This is because these roles are initiated in parallel and too many messages would need to be generated export of images e g examination
22. away from the radiated object as possible always wear an apron use badges to monitor the radiation received collimate as much as possible keep the focal spot to skin object distance as large as possible ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Radiation safety 2 8 ALLURA XPER FD20 SERIES NOTE Document version 3 0 remove all unnecessary obscuring objects from the primary beam including the operator s hands for extra operator safety keep the X ray source under the table use the radiation disable switch at all times except when the radiation procedure is in progress to prevent the possibility of radiation being emitted by an inadvertent activation of an irradiation switch release all hand foot switches in case the display of live images stops release and depress the foot hand switches again when the requested X ray does not start or stop automatically Filtration The maximum attenuation equivalent of the tabletop is 1 43 mm Al The minimum inherent filtration at 75 kV of the X ray tube collimator is 2 5 mm Al Besides a wedge filter of 1 mm brass CuZn37 R 019 22 mm Al equivalent at 75 kV an additional filter can be set depending the Beam Limiting Device BLD that has the following values BLD Type number Additional Filter 12NC No Filter 9896 010 22xxx 1 0 1 mm Cu
23. cycles 70 U 30 dip U for 25 cycles lt 5 295 dip U for 5 sec 3 Alm t 2 kV for power 2 common mode lt 5 Ui 79576 dip in U for 0 5 cycle 40 U 6076 dip in U for 5 cycles 70 U 30 dip U for 25 cycles lt 5 U 79576 dip U for 5 sec 3 A m Note U is the ac mains voltage prior to application of the test level Appendices Mains power quality should be that of a typical commercial or Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems EMC compliance 8 4 Immunity test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Electromagnetic immunity Portable and mobile RF communications equipment Guidance and manufacturers s declaration electromagnetic immunity IEC 60601 test Compliance Electromagnetic environment guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the Allura Xper system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 Vrms d 3 5 at 150 kHz to 80 MHz 150 KHz to 800 MHz 3 3 V m
24. error Failure accessing objects in the source repository job failure invalid or not existing ROID input parameter The job contains invalid or incomplete parameters Connecting failed Network or DICOM association problems The printer can not execute the required command The pixel depth is not valid Unknown error value is returned from the ACP component The lateral geo stand is not in working position The Longitudinal movement is not available FDPA is not possible A DICOM file cannot be read because it is missing or it contains corrupt data The wall thickness related results cannot be computed The file containing the values of healthy people cannot be found No chemicals for development available No connection with printer Printer Not Found When lines are crossing each other when drawing a density measurement it is not always clear what the user meant to include in the density calculation therefore crossing lines are not allowed in a XYZ measurement System and error messages Message and error handling System and error messages Displayed Message No edges found Use other image or centerline No exposure possible reselect procedure No film available No fluo possible Selected app does not support fluo No fluo possible Selected aux doesn t support fluo No fluoroscopy possible reselect application No radial normals file using defaults No regional normals
25. error messages Displayed Message Rotation speed reduced to 30 degr s Segment too broad Select a measurement type Select another channel Select another image or correct the contour Select arterial segment Double click when ready Select calibration or analysis method Select distance Select French size Select one of the calibration methods Select procedure to continue Select sphere diameter Selected examination cannot be reopened for acquisition Send report failed Sequence Shutters unavailable May expose outside detection area Smart Mask selected Stand not ready for APC Move to workarea Stenosis too short System Service Mode Table limit Override Table limit reached Use Override to continue ALLURA XPER FD20 SERIES Action Meaning If for DRA the CArm the position is greater 1 30 the Propeller may only move with 30 sec The width of the vessel exceeds the maximum detectable width Detected contour may be incorrect n a Select another channel n a n a n a n a n a n a A condition requires that the procedure has to be reselected n a n a Error in email application Displayed on OMD AGD when Sequence is selected Radiation possibly outside detector area due to unavailable collimator n a Frontal stand must be moved to workarea first The obstruction Stenosis indicated is too short to perform an analysis Fieldservice mode The Restri
26. file using defaults No slager normals file using defaults No X ray possible Tube not inline with detector Out of angulation range Out of rotation range Panhandle not operable Path not found Print report failed check printer Printer communication error please retry Printer configuration is not correct ALLURA XPER FD20 SERIES Action Meaning The part of the image on which the contour detection is performed does not have enough contrast or is saturated Therefore the edges could not be detected Adjusting user adjustable contrast and or brightness does not influence this problem Exposure disabled Manual settings refused Reselect clinical procedure No media on stock The supply magazine is not available Selected clinical application does not support fluoroscopy Fluoroscopy not supported Fluoroscopy disabled Manual settings refused Reselect clinical application The file containing the values of healthy people cannot be found The file containing the values of healthy people cannot be found The file containing the values of healthy people cannot be found Radiation disabled due to X ray tube not in line with X ray detector The angulation of this image is out of the acceptable range The rotation of this image is out of the acceptable range Call service The directory path does not exist Examination reports could not be printed Something wrong on DICOM protocol l
27. off Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message WARNING DAP measurement not recorded WARNING Exposure stopped maximum run length reached WARNING flat det coolant low finish case call service WARNING flat det cooler problem finish case call service WARNING flat det too hot finish case call service WARNING flat detector warming up lower image quality WARNING Grabbing stopped maximum run length reached WARNING Large focus defect small focus used WARNING less than 1000 images can be stored Warning Mask run acquisition not possible WARNING Move shutters into beam reduce SID WARNING Moving stand or table with Coll Switch Override WARNING Physio data unavailable Warning Reduced IQ Perform pre scan calibration WARNING Room temp too high lower image quality Warning Rotate detector before start Rotation scan WARNING Small focus defect large focus used WARNING spectral filter unavail may exceed dose lim WARNING System self test failed X ray affected Action Meaning Area X ray dose not recorded call service Exposure stopped maximum run length reached Finish case call service Finish case call service Degraded image quality due to hot detector call service Degraded image quality due to warm
28. the service contract Without this authorization remote service will be disabled Remote system modifications and service actions that interfere with normal system use must be authorized by putting the system in service mode Interfering remote service activities can be interrupted at any time by the clinical user in order to resume normal use of the system e g in case of an emergency examination Remote service activities are indicated to the user In order to allow remote access the user must switch to the Field service mode The system remains in this mode indicated by a visible bar flag until the user switches back to the normal operating mode Runs made when the system is in the Field service mode will be stored under the Field service mode and will not be visible to the user Always ensure that the system is switched back to the normal operating mode following any remote service activities Remote service functionality is limited in order to guarantee safe operation of the system independent of the remote service activities It is not possible to remotely activate any safety related function such as X radiation or potentially harmful mechanical movements Also it is not possible to remotely modify Patient or examination information in the systems database When extracting data from the system all private patient information i e name date of birth etc is omitted ALLURA FD20 series Do
29. the system Nr 7 EPMed integrated ALLURA XPER FD20 SERIES Document version 3 0 IEC or ISO standard IEC 60601 1 Location of Electrical safety measures equipment Inside and outside The equipment shall be the patient connected to TE X4 environment ethernet and the Monitor Ceiling Suspension video signals of the Allura Xper FD20 series X ray equipment The PE of EPMed equipment HAY X100 shall be connected to PE NP X100 and the PE of the Bedside Cart HAB X earth shall be connected to SAF X100 The mains cable of the EPMed HAY X6 and HAB X Mains shall be connected to the local mains Installation 3 7 3 2 Equipment connections 3 8 Installation ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 4 Document version 3 0 System and error messages 4 1 Messigeundemorbandlinp edit ed unser tert AI Eror AULA System IOS ADS eu testes rp 42 o System restart ose utate tie ete System and error messages 4 1 System and error messages 4 2 System and error messages ALLURA XPER FD20 series Document uersion 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems 4 1 An updated list of messages is still required ALLURA XPER FD20 SERIES 4 1 1 Document version 3
30. the system Nr 5 Room interface examination light roomlighting door contacts hospital emergency switch contact 6 Video equipment First Medical DVD Recorder Second Medical DVD Recorder 3 6 Installation IEC or ISO standard IEC 60601 1 UL 2601 1 IEC standard IEC standard Location of equipment Outside the patient environment Outside the patient environment Outside the patient environment Electrical safety measures The equipment shall be connected to INP X105 NP X106 ATY X2 and NP X111 of the Allura Xper FD20 series X ray equipment The hospital devices shall meet IEC60601 1 UL 2601 1 No screened connection cables shall be used The circuits of the hospital devices shall be insulated from the protective earth The equipment shall be connected to CY X30 of the Allura Xper FD20 series X ray equipment PEofthe video equipment shall be connected to PE CY X500 The mains cable of the video equipment shall be connected to CY X5 The equipment shall be connected to CY X31 of the Allura Xper FD20 series X ray equipment PEofthe video equipment shall be connected to PE CY X500 The mains cable of the video equipment shall be connected to CY X6 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Equipment connections 3 2 Item Equipment forming part of
31. ua auqa a qaa 1 7 lE T tended se boda te ete acento dede 1 8 og Compatibility m Sinu 1 9 6 Contra ooo ee bt td 1 10 tbat aaa 1 10 aus uyasha 1 11 Safety Z Z Z Suka Su Os 2 3 2 1 Important safety directions acier tp ipod da 2 3 2 2 Emergency proced res e e elec ede rr da 2 5 25 Electrical safety uu 2 6 2 4 Mechanicalisafety uat a RD 2 7 Jc Explosion safety a a UAR ERO TUN 2 8 E 2 8 2 7 Electromagnetic compatibility EMC 2 9 28 27 Radiation Safety hin h 2 10 29 Network safety security and privacy Rd 2 12 2 10 Toxic hazardous substances and elements 2 13 Disi iir p ede TM 3 3 3 1 Introdut Ho iode tr he ai a a atia bra t 3 3 3 2 Equipment connections 3 4 System and error messages 4 3 4 1 Message and error handling pete bebe 4 3 IMS 4 24 Contents 0 1 Contents Contents aeu eine RL Behe Alea ae 5 3 5 01 Introduction Herba naandaa huasi 5 3 5 4 Planned maintenance programme Lii udine 5 3 52 Rou
32. 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Compliance 1 3 ALLURA XPER FD20 SERIES 1 3 NOTE Document version 3 0 Section 5 Maintenance specifies the planned maintenance activities for the system and also includes those activities that must be performed by the user prior to using the system Section 6 Product disposal gives information about the disposal of part of or all of the equipment in an environmentally friendly way Specifications for the equipment used in the system can be found in section 7 Technical Section 8 Appendices provides additional and supporting information including information about the safety devices for the stand and table movements The Index allows quick and easy reference to the information contained in these Instructions for Use Compliance Terms as used in the Instructions for Use As defined by Philips the Allura Xper FD20 series system includes those items supplied to form a functioning unit Under the terms of the IEC regulations the Allura Xper FD20 series system should be referred to as the Allura Xper FD20 series equipment Refer to section 8 3 4 IEC Definitions for a definition of the terms System and Equipment The Philips Allura Xper FD20 series complies with relevant international and national standards and laws Information on compliance will be supplied on request by your local Phil
33. 4 ALLURA XPER FD20 SERIES WARNING 6 4 6 4 1 NOTE CAUTION Document version 3 0 Do not dispose of the Allura Xper FD20 series system or any parts of it with industrial or domestic waste The system may contain materials such as lead tungsten or oil or other hazardous substances that can cause serious environmental pollution It is advisable to contact your Philips Service Organization before disposing of the Allura Xper FD20 series system Philips gives support for recovery of reusable parts the recycling of useful materials by competent disposal companies safe and effective disposal of equipment For advice and information contact your Philips Service Organization first or otherwise Philips Medical Systems at the address below Philips Medical Systems Dept Corporate Industrial Policy and Technology P O box 10 000 5680 DA Best The Netherlands Fax 31 40 27 63017 Fitting removing and disposing of batteries Battery replacement for remote control For safe operation the batteries must be replaced at regular intervals To replace the batteries open the cover on the rear of the remote control remove the old batteries and place new batteries in the position indicated in the battery compartment Battery type Philips PENLITE LR03 Batteries harm the environment dispose of the old batteries in an environmentally sound way Always remove the batteries if the remote control will n
34. 5 kV radiography lt 3 kV pulsed fluoroscopy 40 110 kV lt 3 8 6 Appendices ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Standards and regulations 8 1 ALLURA XPER FD20 SERIES NOTES 8 1 2 Document version 3 0 Parameter mA continuous fluoroscopy mA fluorography radiography mA pulsed fluorography Exposure time cine fluorography radiography pulsed fluoroscopy Post exposure time display mAs Range 0 2 30 mA 1 max mA max mA according to tube type 1 30 mA average value 1 5 165 1 5 165 0 5 850mA Accuracy lt 2 0 1 mA lt 8 0 1 mA t lt 35 ms exp lt 3 0 1 mA t gt 35ms exp lt 8 0 1 mA t lt 35ms exp lt 2 0 1 ms lt 2 0 1 ms lt 276 0 1 mAs Tolerances do not allow for inaccuracies of measurement t in seconds f in Hz Security and Privacy Requirements It is the policy of Philips Medical Systems to adhere to all the required standards and regulations To assist the hospital in fullfilling the Health Insurance Portability and Accountability Act HIPAA requirements introduced by the United States Department of Health and Human Services the following functionality has been added to the Allura Xper FD20 series system Access control Intended
35. 5471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Specifications 7 1 7 1 12 7 1 13 7 1 14 ALLURA FD20 series Document version 3 0 Pivot movement is always manual Pivot movement angle 180 90 or 90 180 Mechanical arret positions 0 13 and 90 Swivel movement is always motorized Swivel movement stroke 782 mm Swivel movement maximum speed 20 sec Cradle movement is always motorized Cradle movement angle 20 Cradle movement fixed speed 4 5 0 4 sec Ceiling suspended radiation shield The ceiling suspended radiation shield comprises 75 90 cm counter balanced two section suspension arm 40 x 50 cm tiltable lead acrylic shield lead equivalence 0 5 mm Pb 35 x 50 cm lead apron lead equivalence 0 5 mm Pb The total weight of the radiation shield and arm is 19 kg Accessory bracket for ceiling suspended radiation shield Accessory bracket for mounting the ceiling suspended radiation shield comprising mounting spigot with a 32 mm diameter groove for securing the ceiling suspended radiation shield Mechanical rating 200 Nm maximum Contrast medium power injectors ANGIOMAT Illumina Synchronized with the system MEDRAD Mark V ProVis Synchronized with the system MEDRAD Adanta Synchronized with the system ACIST Voyager E2000 Synchronized with the system ACIST CVI Synchronized
36. Centerline Analysis Incorrect query criteria Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Indicate catheter segment to calibrate on Indicate center point of sphere Indicate the known distance with two points Indicate three points at the rim of the sphere Invalid characters in Examination ID Invalid characters in name Invalid characters in Patient ID Invalid characters in Request ID or Accession Number Invalid combination of PatientlD AccNr and RequestlD Invalid examination id Job failed The examination folder was deleted LArc must be parked for APC frontal Move to parkposition LArc not ready for APC Move to workarea or parkposition License key error Longitudinal table movement not available Reselect procedure Mark the image Maximum number of images in report reached Monoplane fluo mask biplane fluoroscopy not possible Move frontal stand into working position for Rotation scan Move stand into doctor side position Move stand into head side position Move stand into nurse side position Move stand into proper position No autocal information found Action Meaning n a The selected calibration method is a semi automatic sphere calibration n a n a Invalid examination id Invalid person name Invalid patient id
37. Exposure preparation canceled please retry Exposure preparation failed please retry File already exists File not found Fluoroscopy cancelled please retry Fluoroscopy failed please retry Fluoroscopy not possible reselect application Fluoroscopy not possible system problem Action Meaning The application could not write to a file Configuration info on NT does not match with embedded No communication with the Interventional Hardware Exposure disabled Reselect clinical application Fullfill precondition for exposure run Finalize error during Definition run Geometry initially in replay state which is not allowed No exposure possible due to hospital emergency power No exposure possible due to full image disk Exposure disabled due to full image storage disk Exposure disabled due to insufficient available storage space for this run Exposure disabled Reselect clinical application Exposure disabled due to X ray tube anode not at operating speed Exposure disabled due to tube housing contact open Exposure disabled due to X ray tube anode not at operating speed Exposure canceled Retry Exposure canceled Retry A file already existed A file could not be found Fluoroscopy canceled Retry Fluoroscopy canceled Retry Fluoroscopy disabled Reselect clinical application Fluoroscopy disabled Reselect clinical application System and error messages 4 5 4 1 Message and error handling
38. Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 7 1 7 1 1 NOTE 7 1 2 Document uersion 3 0 Technical data Specifications Environmental requirements Ambient temperature 15 30 C Humidity 20 8096 In order to allow unrestricted air flow around the cabinets of the Allura Xper FD system do not place any item s on top of the cabinets Mains Recording mode of operation Supply configurations Mains Voltage Max Mains resistance Hospital Mains fuse Frequency Measured current Standby Maximum Power consumption Operation Fluoro typical Operation Exposure typical Power Dissipation Velara Generator Continuous short time loading 3 phase Y 4 wires L1 L2 L3 PE 380 460V 10 lt 100mQ for 380V lt 150mQ for 400V lt 200mQ for 440V 480V 63 Amp slow blow 50 60Hz lt 2 Amp per phase 290 Amp during 4 mSec pulses 3 95 kVA 90kV 5mA cont 49 9 kVA 90kV 320mA 1sec 870 W 1 Watt 1 Joule sec Main Cabinet Continuous 3 phase Y 4 wires L1 L2 L3 PE 190 600V 10 N A 43 to 63 Amp slow blow Input wiring must be accordingly 50 60Hz N A Max 11 kVA 650 W 1 Watt 1 Joule sec Technical data 7 1 Specifications 7 4 Technical data 7 1 3 7 1 4 The maximum power available for external equipment 3 additional PC modalities including accessorie
39. Philips Medical Systems 9896 002 0547 Allura Xper FD20 Series INSTRUCTIONS FOR USE Version 0 1 of Document version 3 0 English PHILIPS Published by Philips Medical Systems Nederland B V Philips Medical Systems Nederland B V reserves the right to make changes to both this Instructions for Use and to the product it describes Product specifications are subject to change without notice Nothing contained within this Instructions for Use is intended as an offer warranty promise or contractual condition and must not be taken as such Koninklijke Philips Electronics N V 2007 All rights are reserved Reproduction in whole or in part in any form or by any means electrical mechanical or otherwise is prohibited without the written consent of the copyright holder Document number 9896 002 05471 2007 Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Philips Medical Systems to provide accurate and up to date information to users Published in the Netherlands CE ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 3 0 Contents Introduction oo EUR HERR DE Pra e ERR ERR 1 3 11 About the Allura Xper FD20 series ttp tents 1 3 1 2 About these Instructions for Use 22 22 ccn ttes 1 4 1 3 Compliance ouo sassa
40. RF compliance level above the Allura Xper system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Allura Xper system 5 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances The Allura Xper systems are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Allura Xper system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Allura Xper system as recommended below according to the maximum output power of the communications equipment Appendices ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems EMC compliance 8 4 ALLURA XPER FD20 SERIES Document version 3 0 Recommended separation distances between portable and mobile RF communications equipment and the Allura Xper system Rated Separation distance according to frequency of transmitter maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 8 3 da BSP A w 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed abov
41. System 8 28 Multiple portable socket outlet 8 29 Patient Environment 8 29 M Measurement of technical parameters Exposure time 8 5 mAs 8 6 Peak tube voltage during continuous fluoroscopy 8 4 Peak tube voltage during radiography cine fluorography and pulsed fluoroscopy 8 4 Tube current during continuous fluoroscopy 8 4 Tube current during pulsed fluoroscopy 8 5 Tube current during radiography and cine fluoroscopy 8 4 Index 1 1 R Examination 8 15 Examination report 8 15 Exposure 8 15 Indication of free space for exposures 8 16 Joystick directions 8 17 Viewing examination 8 17 Remote service Remote service session 5 8 Verification test after remote service 5 9 5 Safety T Customer Role in the Product Security Partnership 2 12 Dosimeter calibration 2 11 Electrical safety 2 6 Electromagnetic compatibility EMC compliance 2 9 Emergency procedures 2 5 Equipotential ground connection 2 7 Explosion safety 2 8 Filtration and leakage radiation 2 17 Fire safety 2 8 Important safety directions 2 3 Mechanical safety 2 7 Network safety security and privacy 2 12 Radiation guidelines 2 10 Radiation safety 2 10 Toxic or hazardous substances and elements 2 13 Safety devices for the stand and table movements Balanced movements 8 12 Biosense compatibility 8 12 BodyGuards 8 12 Collision switches 8 12 Dead mans principle 8 11 Reduced performance 8 13 Slip clutches 8 13 Soft c
42. TY X2 MDAI X2 MDP X1 MDY X24 MDY X34 NP X105 NP X106 NP X111 to other Medical Electrical equipment are according to IEC 60601 1 the patient environment Outside the patient network workstation or environment printer shall be connected via Ethernet isolator TN X2 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems Equipment connections 3 2 IEC or ISO Nr standard 3 Physio ECG IEC 60601 1 UL2601 1 Item Equipment forming part of the system Location of Electrical safety measures equipment In patient The equipment shall be connected to MDY X24 of the Allura Xper FD20 series X ray equipment PE of Physio ECG shall be connected to the PE of a wall outlet The PE of this wall environment outlet shall have a direct connection with the busbar on which the X ray equipment has been connected The mains cable shall be connected to a multiple portable socket outlet with insulating mains transformer according to IEC60601 1 1 4 Report printer IEC standard Outside the patient The equipment shall be connected to CY X35 PEofprinter shall be environment connected to the PE CY X500 The mains cable of the printer shall be connected to CY X200 9896 002 05471 Philips Medical Systems ALLURA FD20 series Document version 3 0 Installation 3 5 3 2 Equipment connections Item Equipment forming part of
43. URA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Specifications 7 1 ALLURA FD20 series Document version 3 0 The X ray beam field is always aligned with the image receptor area and the reference axis is always perpendicular to the image receptor plane Isocenter to floor 113 5 cm 44 7 inch Focal spot to isocenter 81 cm 31 9 inch Focal spot to FD SID 89 5 to 119 5 cm 35 2 to 47 inch FD movement speed 10 cm s towards patient 15 cm s away from patient Throat depth 90 cm 35 4 inch Motorized stand rotation 90 left to 90 right Stand rotation speed 12 s Rotational scan From 185 RAO rotation to 120 LAO rotation stand in its head position parallel to the table propeller movement at a speed of up to 55 sec Lateral channel ceiling suspended Lateral ARC N double C arc Rotation and angulation speed 8 s Projection angles see table below L arc position Angulation degrees Rotation degrees Head end of table 45 Caudal to 45 cranial 27 RAO to 115 RAO The X ray beam field is always aligned with the image receptor area and the reference axis is always perpendicular to the image receptor plane so center to floor 113 5 cm 44 7 inch Focal spot to iso center 76 5 cm 30 1 inch Focal spot to image intensifier SID 87 5 to 130 3 cm 34 4 to 51 3 inch FD m
44. age disk error Deselect subtract mode Fluoroscopy disabled due to full image disk Deselect subtract mode Image in other plane is not yet calibrated Call service Call service The Algorithm Library version is wrong Initialisation failed Exposure disabled Coupled injector not ready Exposure disabled Reselect clinical application An internal error occurred in the application There are a number of reasons why this message can be displayed Restart the application and try again If internal errors keep occurring call Service Invalid clinical application has been selected Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Invalid normals detected Invalid procedure please select another procedure Job failure please retry Lateral stand not in working position lateral X ray disabled Longitudinal table movement not available Reselect procedure Missing or corrupt DICOM file No cardiac wall results can be computed No centerline normals file using defaults No chemicals available No connection with printer No crossing lines allowed Action Meaning This message is presented to the user when the normals files contain invalid values The Normals file are standard text files Invalid clinical procedure has been selected Unknown
45. and Release footswitch and rotate detector to landscape Release footswitch move frontal stand to head position Reporting failed to insert image fluoroscopy run Reporting failed to insert image no selection Restriction is not correct Restrictions discarded too complex Resubmitted Reverse position selected Rotation scan not available Reselect procedure Rotation scan time 2615 seconds Action Meaning When Detector is not positioned at Portrait or Landscape the BodyGuard cannot be relied on Therefor the angulation and rotation speed is reduced like when the BodyGuard is OutOfRange Displayed on OMD AGD when Reference is performed using the geometric position of the image on Reference monitor 1 Displayed on OMD AGD when APC Reference is performed using the geometric position of the image on Reference monitor 2 Displayed on OMD AGD when APC Reference is performed using the geometric position of the image on Reference monitor 1 and 2 n a n a n a n a n a The restriction performed by the user does not conform to the description in the manual intended use Too many or too complex restrictions were made The detection will proceed after discarding all restrictions Job Resubmitted User message displayed when Geo subsystem is restarting Time needed to make rotational scan System and error messages 4 19 4 1 Message and error handling 4 20 System and
46. and legal risks The original user may remain liable even if the equipment is given away Product disposal 6 3 6 3 Final disposal of the Allura Xper FD20 series system 6 4 Product disposal 6 3 Existing users are strongly advised to seek advice from their local Philips Medical Systems representative before agreeing to pass on any equipment Alternatively contact Philips Medical Systems at the address given below Philips Medical Systems Dept Corporate Industrial Policy and Technology P O box 10 000 5680 DA Best The Netherlands Fax 31 40 27 63017 Once the equipment has been passed on to a new user the previous user may still receive important safety related information such as bulletins and field change orders In many jurisdictions there is a clear duty on the previous user to communicate such safety related information to new users Previous users who are not able or prepared to do this should inform Philips Medical Systems about the new user so that Philips Medical Systems can provide the new user with safety related information Final disposal of the Allura Xper FD20 series system Final disposal is when the user disposes of the equipment or system in such a way that it can no longer be used for its intended purposes ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Fitting removing and disposing of batteries 6
47. at 80 MHz to l 2 5 GHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of the equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorbtion and reflection from structures objects and people ALLURA XPER FD20 SERIES Document version 3 0 Appendices 8 31 8 4 EMC compliance 8 32 Guidance and manufacturers s declaration electromagnetic immunity Immunity test 60601 test Compliance Electromagnetic environment guidance level level a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Allura Xper system is used exceeds the applicable
48. atient Cannot start prefetching of images from the same examination Changed settings take effect in next analysis Check table longitudinal moves free Bodyguard will be switched off Combination of AccNr RequestID already exists Combining Analysis Confirm Rotation scan end position Confirm Rotation scan start position Connection with worklist manager lost Connection with worklist manager restored Contour too small for Centerline Wall Motion Contour too small for Radial Wall Motion Contour touches boundary Correct the contour or create a report Correction crosses opposite edge Correction too small Could not draw the sphere please retry Delete or modify a density measurement Delete or modify a length measurement Delete or modify an angle measurement Density square too small ALLURA XPER FD20 SERIES Action Meaning Can not start prefetch on different patient Can not start prefetch on same examination Occurs in current analysis when user changes something in Setup Notify user about table movement Combination of AccNr and RequestID already exists Combining the new selected image run with the current analysis Ris connection is temporary off line Ris connection is back on line The detected contour is not big enough in order to perform a Centerline Wall Motion Analysis There are not enough points in the contour in order to calculate a radial wall motion Warning indi
49. bbing down with a dry woollen cloth Do not use abrasive polishes To preserve the finish use non abrasive WAX Patient straps The Patient straps can be washed and sterilized Patient straps should be washed cleaned as required in accordance with the manufacturer s instructions Disinfection parts of the equipment including accessories and connecting cables can be disinfected by wiping them with a cloth dampened with disinfectant Never use corrosive or solvent disinfectants If you are in any doubt about the nature of a disinfecting agent do not use it Flammable or potentially explosive disinfecting sprays must not used since the resultant vapour could ignite causing injury and or damage to equipment Disinfecting a medical equipment room by means of sprays is not recommended since the vapour can penetrate the equipment causing electrical short circuits or corrosion If non flammable non explosive spray disinfectants are to be used the equipment must first be switched off and allowed to cool This prevents convection currents drawing disinfectant mist into the equipment Plastic sheeting must be used to cover the equipment thoroughly following which disinfectant spraying can take place Once all traces of the disinfectant vapour have dispersed the plastic sheeting can be removed and the equipment itself can be disinfected in the recommended way Maintenance 5 11 5 5 Cleaning and disinfection
50. cating that the contour touches the image boundary n a correction is drawn by the user which would if calculated have a negative stenosis A correction to the contour has been requested that is too small to process Displayed when the manual marking of the sphere fails n a n a n a XYZ rectangle was drawn too small Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Difference s in DICOM file detected Do you really want a new acquisition selection Draw a density measurement Draw a length measurement Draw an angle measurement Draw the contour Draw modify or delete a density measurement Draw modify or delete a length measurement Draw modify or delete an angle measurement Edit contour select analysis or create report Emergency power active low load fluo flavor selected Enter a calibration factor Enter corrections and select processing method Enter restrictions finish with double click Error parsing INI file Defaults used Error parsing SET file Defaults used Exam can not be discontinued Examination cannot be added to the local database Examination cannot be closed Examination cannot be deleted Examination cannot be selected for reviewing Examination ID already exists use other Examination is already selected fo
51. ch 4 release the footswitch Use the Float tabletop control 1 on the Xper geometry module to position the center of the intersection of the two lead rulers to the center of the image Initiate fluoroscopy by pressing footswitch 4 and write down the ruler values A1 to D1 corresponding to the edges of the image see illustration below ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Routine user checks programme 5 2 ALLURA XPER FD20 SERIES 10 Position an adequate size film cassette on top of the rulers 11 Expose the film by performing fluoroscopy 4 The maximum density of the developed film should be 0 9 0 1 12 Write down the ruler values A2 to D2 see illustration below B2 13 Determine the distance X cm between the focal spot and the tabletop 14 For each edge A to D calculate the following Value 2 Value 1 lt X 50 Document version 3 0 Maintenance 5 7 5 3 Remote service 5 8 EXAMPLE 5 3 WARNING Maintenance Al 7 2 6 8 and X 85 the formula gives 16 8 7 lt 85 50 0 2 1 7 which is OK If any calculated value is larger than X 50 the beam limiting device is malfunctioning and Service should be called Remote service Remote service session The authorization for performing remote service is part of
52. ch is the distance of the Focal Spot of the X ray source to the Beam IsoCenter see Figure 8 3 The SOD is a fixed value which is 76 5 cm for the PolyG2 Larc C and Larc N and 81 cm for the Clea ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA XPER FD20 SERIES NOTE Document version 3 0 Interventional Reference Point The Interventional Reference Point is a point in the center of the X ray beam at 15 cm from the Beam IsoCenter in the direction of the Focal Spot of the X ray source see Figure 8 3 Minimum Source Skin Distance The Source Skin Distance is the actual distance between the Focal Spot and the skin of the patient where the X ray radiation enters the patient see Figure 8 3 The minimum Source Skin Distance is 38 cm in accordance with HHS for which purpose a spacer is supplied It is the operator s responsibility to use the spacer which is according HHS Source Skin Distance HHS The Source Skin Distance HHS is used for Entrance Doserate Limitation according to HHS FDA legal standards The Source Skin Distance HHS is the distance from the Focal Spot of the X ray source to a point 30 cm 300 mm in front of the mechanical surface of the Image Detector when no anti scatter grid attached The Source Skin Distance HHS is calculated based on the SID and the Receptor Correction SSD HHS SID 30 cm
53. ction that limits the TiltPatientSupport and ChangeHeight is overridden The PatientSupport Movement has stopped due to the SafeArea Restriction Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Table Stand collision prevention active Testshot Failure overexposed please retry Testshot Failure please retry Testshot Failure Underexposed please retry The centerline drawn has too many points The centerline drawn is too short The report can now be saved The restriction crosses the arterial centerline The restriction drawn is too short This examination is already closed This patient already exists merge with existing patient This request already exist do you want to merge with the existing Too few centerline points defined Too many centerline points defined Too many entries found restrict WLM query Too many measurements Total free space 1 s images Transfer imported images cannot be exported Transfer no job submitted check selection criteria Tube anode not at operating speed low load fluo flavor selected Action Meaning Motorized movement is stopped or not started by software to prevent a collision between the table and the frontal stand Overexposed Testshot Testshot failed retry Underexposed Testshot he us
54. cument version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Remote service 5 3 ALLURA FD20 series Document version 3 0 The remote access protocol is a standard protocol and not dependent on the system s version The remote service center does not need knowledge about the system version or configuration in order to contact the system System availability should be maximum for remote service The remote service policy includes automatic remote system access during times that the system is not normally used 24 hr data inspection access should be possible No other functionality is required at that time Part of system may be down Availability should however not lead to unacceptable system wear cost or power consumption compromise may be needed e g a guaranteed timeslot in which the system is accessible It should be possible to load new software parts and parameter sets on the system via the remote service connection Downloaded software and parameter sets will only become available for the clinical user after system verification by the user for limited modifications or by an on site service engineer When the downloaded software fails the original situation can be restored The tools used for loading new software must be verified according to the applicable standards It will be possible to transfer images from the system to a service PC and vice ver
55. cument version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Specifications 7 1 7 1 5 7 1 6 ALLURA FD20 series Document version 3 0 Tube housing ROT GS 1004 for oil cooled X ray tube with thermal safety switch Cooling unit heat exchanger for direct and continuous forced cooling with oil High Voltage cables MRC GS 05 08 and cooling unit CU 3101 lateral Maximus ROTALIX Ceramic tube MRC GS 05 08 with anode heat storage capacity of 2 4 MHU and 0 5 0 8 mm nominal focal spot values maximal 45 and 85 kW short time load Grid switching at pulsed fluoroscopy Continuous loadability 3400 W at 21 degrees Celsius room temperature Dose management with SpectraBeam filtration with 0 2 0 5 1 mm CU eq Tube housing ROT GS 1008 for oil cooled X ray tube with thermal safety switch Cooling unit heat exchanger for direct and continuous forced cooling with oil High Voltage cables LCD monochrome and colour monitors 18 inch Weight 7 7 kg Size width x height x depth 41 0 x 36 2 x 10 5 cm 16 1 x 14 3 x 4 1 in Mains voltage 90 264 V Mains frequency 50 60 Hz Maximum power consumption 70 W LCD monitor ceiling suspension and actuator Weight load and dimensions Type total weight kg Width x Height x Depth mm 2 fold 115 850 x 590 x 400 mono plane only 3 fold 145 1424 x 790 x 524 mono plane only 4 fold 155 1250 x 1150 x 524
56. d X ray operator End Systolic End Systolic Volume ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Abbreviations 8 5 Abbreviation Explanation FD Flat Detector FF Free Format HCU Hard Copy Unit HDT Head Down Tilt HIPAA Health Insurance Portability and Accountability Act HIS Hospital Information System HR Heart Rate HUT Head Up Tilt ID Identification IEC International Electro technical Commission IR Infrared Radiation viewpad IS Information System KVM Keyboard Video Mouse KVM switch LAO Left Anterior Oblique LCD Liquid Crystal Display LED Light Emitting Diode LIH Last Image Hold LVA Left Ventricular Analysis MDVDR Medical Digital Video Disc Recorder MPPS Modality Performed Procedure Step Obs D Obstruction Diameter Obs len Obstruction length OMV On Monitor Viewpad OSD On Screen Display PA Posterior Anterior PACS Picture Archiving and Communication System PC Personal Computer PE Protective Earth QCA Quantitative Coronary Analysis QVA Quantitative Vessel Analysis RAO Right Anterior Oblique Ref D Reference Diameter RIS Radiology Information System ALLURA XPER FD20 series Document version 3 0 Appendices 8 35 8 5 Abbreviations 8 36 Appendices Abbreviation ROI ROT RWM SID SV SWM TFT TSD TSF TSM TTD VCR VFR WLM WM WS WT XDR Explanation Region Of Interest Rotation Regional Wall Motion Source to Imag
57. ded as they can cause injury to the patient If the table is pivoted by more than 13 the BodyGuard cannot fully safeguard the patient during rotation and angulation movements Do not place a solid non conducting object on the patient as such objects cannot be detected by the BodyGuard sensor A collision can then occur with the object causing injury to the patient Appendices 8 13 8 3 Glossary 8 14 Appendices CAUTION 8 3 8 3 1 When the tabletop is fully extended towards the C arm do not lower it and do not angulate the C arm caudally as the tabletop can collide with the inside of the C arm trapping the patient s fingers If extreme projections are required there is risk of collision between the C arm stand and an operating module and or table mounted radiation protection device This must be avoided as it can cause damage to the equipment Glossary System definitions Doctor and nurse side of table 33720020 Top view of patient table 1 Doctor side 2 Nurse side 3 Foot end The doctor side is the right side of the table which is defined as the right side of the patient The patient lies on his her back on the table with feet pointing towards the tablebase With this patient orientation the left side of the table is the nurse side and the foot end is the side towards which the patients feet are pointing Acquisition examination An acquisition examination is automatically crea
58. e WARNING Automatic printing failure WARNING Automatic write to CD failure WARNING AutoWedgeFollow function not available Warning Biosense image correction filter active Warning BodyGuard is switched off ALLURA XPER FD20 SERIES Action Meaning Degraded image quality due to overloaded X ray tube Degraded image quality due to X ray tube anode not at operating speed It is not known which side to correct The range for CFR SFR needs to be between Oand5 The user has positioned the valve marker the wrong place During the acquisition of the first run in a Run subtract Bolus chase or Run subtract Rotational scan procedure a write error occurred resulting in not having stored one or more images on disk This may lead to bad run subtraction results afterwards The operator can continue and take this risk or reselect the procedure and start all over again x sec of exposure can be stored on an almost full image storage disk New settings loaded by FS Reported when the Lateral Stand has lost the stored adjustment data No automatic archiving for closed examination folder No automatic printing for closed examination folder No automatic archiving for closed examination folder Autowedge follow function is not available Indicates that the BioSense image correction filter is active The user is warned that during the free interactive FDPA movement the bodyguard is switched
59. e the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorbtion and reflection from structures objects and people Appendices 8 33 8 5 Abbreviations 8 34 Appendices 8 5 Abbreviations Abbreviation A sten D sten AEP AK R ANG AP APC AVA BC BSA CAUD CF CIS CREF CRT CWM DA DAP DICOM DSA ECG ED EDV EF EMC EPX ES ESV Explanation percentage Area stenosis percentage Diameter stenosis Area Exposure Product Air Kerma Rate Angulation Anterior Posterior Automatic Position Control Automated Vessel Analysis Bolus Chase Body Surface Area Caudal Calibration Factor Cardiac Index Cardiology Information System Cardiac Output Cranial Regional Contribution to global EF Cathode Ray Tube Centerline Wall Motion Digital Angiography Dose Area Product Digital Imaging and Communications in Medicine Digital Subtraction Angiography Electro Cardio Gram End Diastolic End Diastolic Volume Ejection Fraction Electro Magnetic Compatibility Examination Patient type an
60. e Distance Stroke Volume Slager Wall Motion Thin Film Transistor Tabletop Shifting Device Trace Subtract Fluoroscopy Touch Screen Module Tabletop Travel Distance Video Cassette Recorder Variable Frame Rate Worklist Management Wall Mass Wall Stress Wall Thickness Wall Volume Xcelera DICOM Recorder ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Index Cleaning 5 11 Chrome parts 5 11 Enamelled parts and aluminium surfaces 5 11 Patient straps 5 11 D Disinfection 5 11 Dose related definitions Air Kerma AK 8 17 Air Kerma Rate 8 18 Dose Area Product DAP 8 18 Dose Area Product rate 8 18 Interventional Reference Point 8 18 Reference air kerma 8 17 Skin dose 8 18 E EMC compliance Electromagnetic emissions 8 29 Electromagnetic immunity 8 30 Electromagnetic immunity Portable and mobile RF communications equipment 8 31 Recommended separation distances 8 32 G Geometric terms Angle information 8 19 Patient and beam positioning 8 20 Patient orientation 8 19 ALLURA XPER FD20 SERIES Document version 3 0 H HIPAA requirements Access control 8 7 Audit trail 8 8 Certificates 8 9 Field Service 8 9 Implementation 8 8 Network time synchronization 8 8 Security and node authentication 8 8 IEC Definitions Functional connection 8 28 Medical electrical equipment 8 28 Medical Electrical
61. ed on a regular basis usually every day The Anti virus definitions update mechanism automatically looks for updated virus definition files at system startup and implements them if available For optimal protection it is advisable to restart the system as soon as new virus definitions are loaded onto the system Cleaning and disinfection Cleaning and disinfection of the Philips Allura Xper FD20 series will normally be required in connection with most of the intended applications Guidelines for each are given below To avoid electric shock always isolate the equipment from the mains electrical supply prior to cleaning disinfecting or sterilizing it Never allow water or other liquids to leak into the equipment as this may cause short circuits or corrosion ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Cleaning and disinfection 5 5 ALLURA XPER FD20 SERIES 5 5 1 5 5 2 WARNING CAUTION Document version 3 0 Cleaning Enamelled parts and aluminium surfaces Enamelled parts and aluminium surfaces should only be wiped clean with a damp cloth and mild detergent and then rubbed down with a dry woollen cloth Never use corrosive cleaning agents solvent or abrasive detergents or polishes If you are uncertain of the nature of a cleaning agent do not use it Chrome parts Chrome parts should only be cleaned by ru
62. ed was negative or not within the acceptable range Call service The centerline wall motion analysis cannot be computed System and error messages 4 3 4 1 Message and error handling 4 4 System and error messages Displayed Message Centerline wall motion graph cannot be displayed Communication error with worklist manager Correction not applied please retry Current image is not yet calibrated Detection failed please retry DETECTOR Bodyguard Override DETECTOR TUBE Bodyguard Override Error in normals file title Error reading file Error reading font section defaults used Error reading normals file Error reading report section defaults used Error reading setup section defaults used Error reading spreadsheet section defaults used Error reading Ul section defaults used Error reading version of normals file ALLURA XPER FD20 SERIES Action Meaning The centerline wall motion graphic cannot be displayed Ris communication error The ventricle correction is not applied please retry The dicom file did not contain a calibration factor The ventricle detection failed please retry The user is pointed out that the BodyGuard at the detection that limits the speed of the CArm or Propeller to very low speed is overridden The user is pointed out that the BodyGuard at the detection and tube that limits the speed of the CArm or Propeller to very low speed if overridden This error occurs if n
63. efect DETECTOR Bodyguard active WARNING active DETECTOR TUBE Bodyguard WARNING door WARNING to continue Door contact failure please close Emergency stop activated reset WARNING exposure buzzer defect Warning Exposure not possible Warning Film jam Warning Film supply low WARNING Fluo buzzer defect Warning Frontal geometry standposition unknown WARNING Grabbing disabled image disk error Action Meaning Call service Sensor defect detected at POST call service Sensor a little bit wet or dirty no safety issue Sensor very dirty or defect detected after POST Availability of chemicals reached threshold value Communication with collimator defect cannot be used call service Collimator defect cannot be used call service The BodyGuard at the detector limits the speed of the C arm or Propeller to very low speed The BodyGuard at the detector and tube limits the speed of the C arm or Propeller to very low speed Door contact failure Ensure the examination room door has been closed The user has pressed the emergency stop button A warm restart is required to enable the motorized movements again End of exposure buzzer unavailable call service Call service Something wrong with transportation of medium The number of media on stock reached a threshold value Fluoroscopy buzzer defect call service The position of the frontal stand is unkn
64. egulations which have the force of law within the Jurisdiction s concerned If you are in any doubt about the laws and regulations which apply to the operation of this equipment do not use it Safety 2 3 2 1 Important safety directions 2 4 Safety WARNINGS WARNINGS Maintenance amp faults Do not use the Allura Xper FD20 series equipment for any application until you are sure that the User Routine Checks have been satisfactorily completed and that the periodic maintenance of the Allura Xper FD20 series is up to date If any part of the Allura Xper FD20 series is known or suspected to be defective or wrongly adjusted DO NOT USE the Allura Xper FD20 series until a repair has been made Operation of the Allura Xper FD20 series with defective or wrongly adjusted components could expose the operator or the patient to radiation or other safety hazards This could lead to fatal or other serious personal injury or to clinical misdiagnosis clinical mistreatment You can find information about the User Routine Checks Programme and the periodic Planned Maintenance Programme the Maintenance section of this Instructions for Use A Safety awareness Do not use the Allura Xper FD20 series system for any application until you have read understood and know all the safety information safety procedures and emergency procedures contained in this SAFETY section Operation of the Allura Xper FD20 series
65. ely used Medical Device Isolation Architecture for this purpose Such perimeter and network defenses are essential elements in a comprehensive medical device security strategy ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Toxic or hazardous substances and elements 2 10 2 10 Allura Xper FD System Lead Pb Electronic modules x Flat screens x Detector x Radiation sheilding x Collimator x Grid x X ray tube x Electromechanical parts Toxic or hazardous substances and elements The following table details the Toxic or hazardous substances and elements which are present in the Allura Xper FD system Toxic or Hazardous Substances and Elements Mercury Cadmium Hexavalent Polybrominated Polybrominated Hg Cd Chromium Biphenyls PBB Diphenyl Ethers Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ T11363 2006 X Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ T11363 2006 ALLURA FD20 series Document version 3 0 In this product perchlorate material is present
66. ent is therefore designed and manufactured to comply with relevant guidelines for environmental protection As long as the equipment is properly operated and maintained it presents no risk to the environment However the equipment may contain materials which could be harmful to the environment if disposed of incorrectly Use of such materials is essential for the implementation of certain functions and for meeting certain statutory and other requirements This section of the Manual is directed mainly at the user of the equipment or system the body with legal authority over the equipment Operators are not usually involved in disposal except in the case of certain batteries section 6 4 Fitting removing and disposing of batteries Passing the Allura Xper FD20 series system on to another user If the Allura Xper FD20 series system is to be passed on to another user who is to use it for its intended purpose then it should be passed on in its complete state In particular the existing user should make sure that all the product support documentation including this Manual is passed on to the new user A new user should be made aware of the support services that Philips Medical Systems provides for installing commissioning and maintaining the equipment or system and for the comprehensive training of operators Existing users must bear in mind that passing on medical electrical equipment to new users may present serious technical medical
67. er created too many centerline segments clicked too many times A centerline is drawn with not enough segments i e less than two points n a The user has drawn a restriction that crosses the centerline of the artery A minimum length is needed by the algorithm library in order to restrict n a The patient id already exists Do you want to merge the patient information The AccessionNumber and or RequestlD already exists Do you want to merge the study information The user has not drawn enough segments in order to detect a contour minimum 2 The user has created too many segments when drawing the centerline n a The maximum number of measurements allowed has been reached x images can be stored n a Transfer No ROIDs were selected for this job Degraded image quality due to X ray tube anode not at operating speed System and error messages 4 21 4 1 Message and error handling 4 22 System and error messages Displayed Message Tube overloaded low load fluo flavor selected Tube rotor problem low load fluo flavor selected Unable to determine the side to correct Unexpected CFR or Hemo values Update is not allowed Valve is not correctly indicated WARNING Run subtract might fail write problem WARNING 1 s seconds exposure left on image disk WARNING Acceptance Required WARNING Adjustment of lateral stand required WARNING Automatic archiving failur
68. ered to be the body with authority over the equipment operators are those persons who actually handle the equipment Before attempting to operate the Allura Xper FD20 series you must read these Instructions for Use noting and strictly observing all WARNINGS and CAUTION notices This symbol used throughout the Instructions for Use indicates a WARNING A WARNING alerts you to a potential serious outcome adverse event or safety hazard Failure to observe a warning may result in death or serious injury to the operator or patient A CAUTION alerts you to where special care is necessary for the safe and effective use of the Allura Xper FD20 series Failure to observe a caution may result in minor or moderate personal injury or damage to the Allura Xper FD20 series or other property and possibly in a remote risk of more serious injury andlor cause environmental pollution NOTES highlight unusual points as an aid to the operator This Introduction section gives information about compliance and regulatory requirements Section 2 Safety details the safety directions that must be observed to ensure the safe and effective use of the Allura Xper FD20 series system Section 3 Installation provides information about the equipment connections Section 4 System and error messages gives a complete list of all messages that can displayed on the user interfaces ALLURA FD20 series Document version
69. est The Netherlands Fax 31 40 27 63017 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Other manuals 1 8 ALLURA XPER FD20 SERIES 1 8 Document version 3 0 Other manuals This Instructions for Use describes the Allura Xper FD10 series If additional equipment is used with the system each will have its own manual Introduction 1 11 1 8 Other manuals 1 12 Introduction ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 3 0 Safety 2 1 Important safety directions rrt ERES 2 3 2 2 Emergency procedures aoo DODGE TH DR dU 2 5 219r yu yaya 2 6 DA Mechanical safely et 2 7 2 5 Explosion safey anoo etre rd be o UP ds 2 8 2 0 Ele RALLY ect as 2 8 2 7 Electromagnetic compatibility EMC eerte ren rns 2 9 2 8 Radiation safety ba ede prep Rer 2 10 29 Network safety security and privacy adu 2 12 2 10 Toxic or hazardous substances and elements 2 13 Safety 2 1 Safety 2 2 Safety ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems
70. evel Waiting for reply took to long Configuration items are missing or incorrect Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Printer problem inspect printer Query failed check search parameters and try again Query for worklist from worklist manager failed Radial wall motion can not be computed Receiver film magazine full Regional wall motion can not be computed Release foot handswitch and restart system Reporting cannot copy image try again Review module control room not operable Rotation scan time too low Reselect procedure RPML file could not be parsed Run aborted tube overload limit Select procedure to continue Select Smart Mask not possible Slager wall motion cannot be computed Speed controller not operable Action Meaning Something wrong with the receiver magazine e g full User should inspect the printer Hardware error Not enough memory available in printer The processor of the printer detects an error The query failed RIS query failed The radial wall motion analysis cannot be computed The receiver magazine is full The regional wall motion analysis cannot be computed Exposure Fluoroscopy hand foot switch pressed while starting system Unable to create the PNG file in the pre
71. evices could lead to fatal or other serious personal injury Intended use amp compatibility Do not use the Allura Xper FD20 series for any purpose other than those for which it is intended Do not use the Allura Xper FD20 series with any products other than those which Philips Medical Systems recognizes as compatible Operation of the Allura Xper FD20 series for unintended purposes or with incompatible products could lead to fatal or other serious injury It could also lead to clinical misdiagnosis clinical mistreatment Intended use of the Allura FD20 series system is described under the heading Intended use in the Introduction section of this Instructions for Use Compatibility is discussed under the heading Compatibility in the Introduction section of this Instructions for Use Emergency procedures A the event of a system movement emergency press emergency STOP to block all movements except manual stand rotation and tabletop float for table without tilt only To ensure free all round access to the patient do not switch off the X ray system using a local mains power switch In the event of a clinical emergency involving a patient e g a patient requiring Cardio Pulmonary Resuscitation CPR DO NOT press emergency power off move the Flat Detector away from the patient pivot the table to provide clear all round access to the patient move the tabletop into the fully ret
72. f images up to four physiological data streams and some run attributes which describe the properties of the exposure run Typical run attributes are spatial resolution of the images number of images in the run acquisition parameters e g Xper setting name kVp value image processing parameters etc For image processing parameters different sets are maintained one for image processing during acquisition one for image processing during review this set can be modified by the operator both for subtracted and non subtracted display Appendices 8 15 8 3 Glossary 8 16 Appendices NOTES Indication of free space for exposures There is no continuous display of the amount of free space on the image disks When a new acquisition examination is selected the system displays a guidance message indicating the total amount of free disk space available During the examination guidance messages are generated in case the free S pace should become a problem When the total amount of free disk space drops below the limit defined in the Xper settings a warning guidance message will be generated each time an exposure run is made The operator can then manually delete old examinations in order to get more free disk space When less than 1000 images are available for exposure a warning guidance message is generated When less images are available for exposure than needed to complete a normal run the e
73. her than those intended and expressly stated by the manufacturer as well as incorrect use or operation may relieve the manufacturer or his agent from all or some responsibility for resultant non compliance damage or injury Federal law restricts this device to sale by or on the order of a physician Compatibility The Allura Xper FD20 series described in this Instructions for Use should not be used in combination with other products or components unless such other products or components are expressly recognized as compatible by Philips Medical Systems A list of such products and components is available on request from the contact address given in the paragraph on Compliance Changes and or additions to the Allura Xper FD20 series should only be carried out by Philips Medical Systems or by third parties expressly authorized by Philips Medical Systems to do so Such changes and or additions must comply with all applicable laws and regulations that have the force of law within the jurisdiction s concerned and with best engineering practice Changes andlor additions to the Allura FD20 series that are carried out by persons without the appropriate training and or using unapproved spare parts may lead to the Philips Medical Systems warranty being voided As with all complex technical products maintenance by persons not appropriately qualified andlor using unapproved spare parts carry serious risks of damage to the Allura X
74. ient environment the level of safety stipulated in IEC 60601 1 1 provided that the equipment listed in the table below has been provided with the electrical safety measures described Installation 3 3 3 2 Equipment connections 3 4 3 2 Item Equipment forming part of the system Nr 1 Allura Xper FD20 series X ray equipment An Allura Xper FD20 series X ray equipment consists of the following main parts which have been located inside the patient environment Table with control modules Frontal and Lateral stand Frontal and Lateral X ray tube housing assembly with beam limiting devices Frontal and Lateral Flat detector FD assembly Ceiling suspended monitors and target light Optional radiation shields Optional examination light Optional injector An Allura Xper FD20 series X ray equipment consists of the following main parts which have been located outside the patient environment Monitors e Keyboard and mouse Control modules Workstation s Frontal and Lateral X ray generator and cooling units Peripheral cabinets Main cabinet for system control mains power distribution with user interfaces and viewing monitors 2 Network Xcelera Viewforum workstation and network printer Installation IEC or ISO standard IEC 60601 1 UL 2601 1 IEC standard Equipment connections Location of Electrical safety measures equipment Partly in and outside The electrical connections A
75. ificates local machine the location of the tools for certificate installation Appendices 8 9 8 1 Standards and regulations 8 10 Appendices 8 1 3 8 1 4 Certificates should be used between nodes to enable them to validate the identity of each other It is the responsibility of the Integrating the Healthcare Enterprise IHE to define the maximum validity period of certificates in its security policy Type B symbol The type B applied part symbol can be found on the patient table 33725440 Figure 8 1 B applied part symbol Definition applied part part of the equipment which in normal use must come into physical contact with the patient for the equipment to perform its function or can be brought into contact with the patient or needs to be touched by the patient Where normal use is defined as follows Operation including routine inspection and adjustments by the operator and stand by as described in the instructions for use Image Tests Results from a clinical evaluation of the Philips dynamic Flat Detector show that images produced in both fluoroscopy and acquisition are similar or better than the current level of Philips Image Intensifier TV images The general impression is that the noise is less obtrusive on the detector imaging in comparison with the Image Intensifier TV imaging Some stents and angioplasty wires are more visible with the dynamic Fla
76. image disk space becomes low please delete exams Function can not be applied on imported examination Function can not be applied AccNr and RequestID in use Function can not be applied pending jobs in the queue Geometry module pedestal not operable Geometry not in Rotation scan start position Geometry unavailable Reselect procedure after Geometry restart Illegal input text format Imaging module pedestal not operable In order to move the LArc move Frontal Stand to headside Incorrect contour for centerline WM calculation Incorrect query criteria ALLURA XPER FD20 SERIES Action Meaning The interventional Hardware is busy or not ready Fluoroscopy images cannot be stored Fluoroscopy images cannot be stored Name to identify a fluo grab run Fluoroscopy disabled due to max fluoroscopy time elapsed Fluoroscopy trace not possible FluoStore not available due to full image disk The image in use is a subtracted image Only manual pixelsize or autocalibration is available for subtracted images Low on storage space for examination Delete examinations n a n a n a Call service Move frontal stand into working position for Rotation scan n a Illegal text format Call service When the Frontal Stand is parked PolyG2 Floor or at nurse or doctorside Clea Floor the LArc cannot be parked The contour drawn by the user could not be used to calculate the
77. in EPX with the parameters DefaultPOIHeight DefaultPOlILongitudinal and DefaultPOlLateral These parameters are defined relative to a coordinate system which is defined between the heels of the patient on the surface of the tabletop see Figure 8 8 With the default position of the patient on the tabletop nose up and legs down and with the top of the head aligned with the top of the tabletop the position of the coordinate system is defined assuming a DefaultPatientLength The DefaultPatientLength mm is also defined in EPX Appendices ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA FD20 series Document version 3 0 Default POI Longitudinal Default POI Longitudinal is the distance mm of the default Point Of Interest from the bottom of the patients feet Default POI Lateral Default POI Lateral is the position mm of the default Point Of Interest in the patient sideways When positioned to the right of the patient doctor side of the table the value is negative When positioned to the left of the patient nurse side of the table the value is positive Default POI Height Default POI Height is the distance mm of the default Point Of Interest in the patient from the surface of the tabletop d P gt lt Default Point Inr gt Longitudinal
78. in Lithium coin cells and or batteries Perchlorate Material special handling may apply for more information go to www dtsc ca gov hazardouswaste perchlorate Safety 2 13 2 10 Toxic or hazardous substances and elements 2 14 Safety ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 3 Document version 3 0 Installation 3 1 3 2 Introduction Equipment connections Installation 3 1 Installation 3 2 Installation ALLURA XPER FD20 series Document uersion 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems 3 1 ALLURA FD20 series Document version 3 0 Installation Introduction The Allura Xper FD20 series equipment must be installed and configured completely by a trained service engineer as part of delivery and hand over During its use or due to changes in the place of installation modifications to the equipment or configuration may be necessary This must be carried out by a trained service engineer The information contained in this chapter is mandatory under the terms of IEC 60601 1 1 A guide for the correct connection of the equipment is described in this document General The Allura FD20 series equipment satisfies the terms of IEC 60601 1 and provides inside and outside the pat
79. ing up of the detector Fluoroscopy image grabbing stopped maximum run length reached X ray tube large focus defect Radiation with small focus Less than 1000 exposure images can be stored due to almost full image disk Geometry has no capabilities for making a replay run Move shutters inside X ray beam to obtain optimal image quality The collision switch of the LArc is overridden No physio data available Warning for STA prescan calibration Lower image quality due to too high room temperature n a X ray tube small focus defect Radiation with large focus Degraded image quality due to unavailable spectral filter Self test failed which may affect X ray System and error messages 4 23 4 2 System restart 4 24 4 2 System and error messages Displayed Message WARNING TUBE Bodyguard active WARNING tube grid defect radiation w o grid Warning Write error run subtraction might fail Worklist manager not configured X ray disabled X ray not possible please close door System restart Action Meaning The BodyGuard at the tube limits the speed of the C arm or Propeller to very low speed X ray tube grid defect Radiation without grid call service Write error subtraction might fail BWLM not configured Radiation disabled Radiation disabled due to open examination room door close door For information about restarting the system refer to the Allura Xper FD s
80. ins transformer secondary windings of mains power distribution unit Physio ECG report printer Reason Check accuracy and functioning of All controls All visible audible indicators Table controls movements SID Shutter speed Check that applied movement is inhibited and that an audible alarm is generated Check oil level and clean oil filter Check maximum earth ground of whole system Clean FD AK check monitors and stability Calibrate Velara generator Check condition Look for damage Calibrate Ensure secure fitting and check for dust and corrosion Check freedom from dust grease and oil Counterweight fasteners and cables All mechanical stops limits Brakes and locks Grease lubricate Air filter liquid filter check pump Replace coolant Calibrate Check for presence and readability of warning label Check insulation resistance Ensure mains electrical supply is provided from a Multiple portable socket outlet with insulating transformer ALLURA FD20 series Document version 3 0 Frequency 6 monthly 6 monthly 6 monthly 6 monthly 6 monthly 6 monthly 6 monthly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly 2 Yearly 2 yearly 2 yearly 2 yearly 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 5 2 Docume
81. ips Medical Systems representative or by the manufacturer from Philips Medical Systems Dept Corporate Industrial Policy and Technology P O box 10 000 5680 DA Best The Netherlands Fax 31 40 27 63017 The Philips Allura Xper FD20 series complies with relevant international and national law and standards on EMC electromagnetic compatibility for this type of equipment when used as intended Such laws and standards Introduction 1 7 1 4 Intended use 1 8 WARNINGS Introduction 1 4 NOTE define both the permissible electromagnetic emission levels from equipment and its required immunity to electromagnetic interference from external sources The use of accessories transducers and cables other than those specified for this equipment may result in increased emissions or decreased immunity The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the user must verify that the system operates normally in the configuration in which it will be used Intended use This Philips Allura Xper FD20 series is intended to be installed used and operated only in accordance with the safety procedures and operating instructions given in this Instructions for Use for the purposes for which it was designed The purposes for which the Allura FD20 series is intended are given below However nothing stated in this Instructions for Use red
82. ized AK values 0 100 1 160 2 290 3 530 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 8 Appendices 8 1 Standards and regulations juice pint p Prope Font 8 3 8 1 1 Measurement of technical parameters ess 8 3 8 1 2 Security and Privacy Requirements eee 8 7 84113 bol ie eat gi iru d e qud ea nn 8 10 OU AME DN E 8 10 8 1 5 Typical Air Kerma onion 8 11 8 2 Safety devices for the stand and table movements 8 11 8 14 BOE System definitions 8 14 832 Dose related definitions Mur 8 17 82597 Geometri terms Du AUN DP DS DOS 8 18 834 De OM duet TERRI RR RARI Ed 8 28 8 4 EMG Sou updated tree Ree 8 29 892 Abbrevidt Ons Sosa ede 8 34 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 3 0 Appendices 8 1 Appendices 8 2 Appendices ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 8 0 8 1 8 1 1 Document version 3 0 Appendices Introduction This section provides the user with additional background and supporting information Section De
83. l reference point 100 x 100 mm Scatter object 25 x 25 x 25 cm Polymethyl methacrylate PMMA according to IEC 60601 2 43 clause 29 208 101 Figure 7 3 ALLURA FD20 series Document version 3 0 gt UK Isocenter Focus distance Focus interventional f Frontal 810 mm reference point P Lateral 765 mm distance Frontal 660 mm Lateral 615 mm Focal Spot Measurement configuration graph SID Frontal 1000 mm Lateral 1000 mm Technical data 7 15 7 2 Stray radiation Normalized isokerma map at 1 m 39 37 in above flo Xper FD20 20 stand frontal position Technique factors Fluoroscopy 120kV no additional filter Y m 3 Figure 7 4 Isokerma map at 100 cm 39 37 inch height 7 16 Technical data ALLURA XPER FD20 SERIES or for Allura Legend Isokerma uGy yGy m 0 01 0 005 0 02 0 01 0 04 0 02 0 08 0 04 2 0 08 Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Stray radiation 7 2 Y m 3 Normalized isokerma map at 1 5 m 59 10 in above floor for Allura Xper FD20 20 stand frontal position Technique factors Fluoroscopy 120kV no additional filter Legend Isokerma uGy uGy m 0 01 0 005 0 02 0 01 ALLURA XPER FD20 SERIES Document version 3 0 Figure 7 5
84. lishments other than domestic and those Harmonic emissions Not applicable directly connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings Voltage fluctuations Not applicable used fer domesuc purposes Flicker emissions IEC 61000 3 3 Appendices 8 29 8 4 EMC compliance Electromagnetic immunity Guidance and manufacturers s declaration electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance advise especially if compliance is not met 8 30 Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are discharge ESD covered with synthetic material the relative humidity should IEC 61000 4 2 t 8 kV air 8 kV air be at least 30 Electrical fast transient burst supply lines supply lines hospital environment IEC 61000 4 4 1 kV for input n a output lines Surge 1 kV differential t 1 kV differential Mains power quality should be that of a typical commercial or IEC 61000 4 5 mode mode hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz characteristic of a typical location in a typical commercial or magnetic field hospital environment IEC 61000 4 8 2 kV for power 2 kV common mode lt 5 Ui 79576 dip U for 0 5 cycle 40 U 60 dip U for 5
85. mination room Biplane fluoroscopy not possible Busy with system startup or recovery Please wait Calibration in progress Cannot merge existing examinations Action Meaning 1Examination protected Proceed 1Examination protected nothing archived or printed Proceed 1Toggle protection Proceed 1Toggle protection Nothing archived or printed Proceed Displayed on OMD AGD when APC 3D RA is performed using the geometric position of selected 3DRA image Other action performed while Acquisition Active Unknown error Select an image run to combine with the current analysis The wrong image was used for Lateral Apex positioning The apex is the point that is the furthest away from the valve A check on the calculation results failed The vessel that is indicated for detection has too many curves The calibration module was not able to autodetect a sphere The exposure of the image is incorrect or the image depth number of bits pixel is set incorrect in the Dicom file Biplane APC is not allowed from the control room because of limited system visibility Biplane fluoroscopy not possible Wait until system has been started up n a Can not change examination ID into an existing examination ID System and error messages 4 13 4 1 Message and error handling 4 14 System and error messages Displayed Message Cannot start prefetching of images from a different p
86. mpatibility EMC for this type of product when used as intended Such laws and standards define both the permissible electromagnetic emission levels from the Allura Xper FD20 series and its required immunity to electromagnetic interference from external sources Other electronic products exceeding the limits defined in such EMC standards could under unusual circumstances affect the operation of the Allura Xper FD20 series Medical electrical products need special precautions regarding EMC and need to be installed and put into service according to EMC information provided in the accompanying documents The use of accessories and cables other than those specified may result in increased emission or decreased immunity The Allura Xper FD20 series should not be used adjacent to or stacked with other products If adjacent or stacked use is necessary it should be observed to verify normal operation See also 8 4 compliance Portable and mobile phones Other electronic equipment that exceeds EMC radiation standards such as certain portable and mobile RF communications equipment can affect medical electrical equipment when used within a specified range A Portable and mobile RF communications can affect medical electrical equipment Use caution when using such communication devices within the specified range of medical electrical devices Safety 2 9 2 8 Radiation safety 2 10 Safety 2 8 WARNING
87. n see in the illustration the protective device lowers the AK by at least one order of magnitude The indicated significant zone of occupancy is designated to be used for radiologic examinations according to section 1 4 Intended use Influence of additional filtering on protection against stray radiation Figure 7 2 presents the protection against stray radiation if no additional filter is applied The following table presents the AK values as percentages of the curves as function of the additional filter selection for filter selection see section 2 8 Radiation safety kV Filter No protection 110 0 100 1 66 2 38 3 19 90 0 64 1 39 2 19 3 8 5 70 0 35 1 18 2 7 1 3 2 3 7 14 Technical data Reduction 0 5 mm lead 1 0 mm lead equivalence equivalence 100 87 69 49 33 27 20 12 6 0 4 1 24 1 3 100 85 64 47 34 24 15 9 0 13 72 3 1 1 0 1 5 mm lead equivalence 100 76 53 32 46 31 17 92 22 12 4 6 1 9 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Stray radiation 7 2 7 2 2 Stray radiation isokerma data Measurement configuration for Allura Xper FD20 20 X ray field size in plane of image receptor 163 x 163 mm w Yr Phantom 25 25 25 cm 4 4 X ray field size in plane of interventiona
88. ncluding the Allura Xper FD20 series equipment and is required to be supplied from a multiple portable socket outlet with insulation transformer is not to be connected to a normal mains electrical supply The electrical safety of the Allura Xper FD20 series equipment may then be compromised and could lead to serious or fatal injury to the patient and or damage to equipment Covers and cables Do not remove covers or cables from this Allura Xper FD20 series unless expressly instructed to do so in this Instructions for Use Dangerous electrical voltages are present within the Allura Xper FD20 series Removing covers or cables could lead to serious or fatal personal injury 2 6 Safety ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Mechanical safety 2 4 ALLURA XPER FD20 SERIES 2 4 WARNING Document version 3 0 Covers or cables should only be removed by qualified and authorized service personnel In this context qualified means those legally permitted to work on this type of medical electrical equipment in the jurisdiction s in which the product is being used and authorized means those authorized by the user of the product Only use the Allura FD20 series in rooms or areas that comply with all applicable laws or regulations having the force of law concerning electrical safety for this type of equipment Always electricall
89. nstraints X ray indicator defect call service The detector spinangle is unknown User should move it manually to default position Shutter defect cannot be moved call service Wedge defect cannot be moved call service Radiation disabled due to overheated detector Exposure disabled because system is shutting down Fluoroscopy disabled because system is shutting down Radiation disabled due to X ray tube defect focus call service XRes unavailable System messages are messages with a lower status of importance and are displayed to inform the user about active system processes The following table shows the System messages valid for all Allura Xper FD20 series system ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message 1Examination protected Confirm deletion 1Examination protected Nothing archived or printed Confirm deletion 1Toggle protection Confirm toggle 1Toggle protection Nothing archived or printed Confirm toggle 3DRA CA Acquisition is currently active Add run and mark image Apex is not ina LAO projection Apex is too close to valve Apex not on contour Arterial curvature too large Automatic detection of the sphere failed Bad exposure conditions found Biplane APC is only selectable in exa
90. nt is being used and authorized means those authorized by the user of the equipment Philips is able to provide a full planned maintenance and repair service on either a call basis or a contract basis Contact your Philips Service Organization To ensure that planned maintenance is performed at the prescribed intervals the user should issue a request to the maintenance organization for planned maintenance to be carried out in accordance with the Planned maintenance programme detailed below Planned maintenance programme Planned maintenance tasks may only be carried out by qualified and authorized service technicians and are comprehensively described in the service documentation summary of the planned maintenance programme is given in the table below sure that the system is in the disable radiation mode before you start any maintenance procedure Review module Disable radiation button 6 If during maintenance the radiation is not disabled inadvertent exposure of personnel to radiation can occur This can cause serious injury Maintenance 5 3 5 1 Planned maintenance programme 5 4 Maintenance Check Controls and indicators Collision sensors Oil level Earth ground Air filters Image quality Allura Xper FD20 series system End stops Stand motion PCBs and racks Bearings Mechanical FD cooling FD cooling FD Warning DHHS label on Xper module Ma
91. nt uersion 3 0 Routine user checks programme 5 2 Check Reason Frequency Alignment Collimator alignment and field limitation 2 yearly Beam alignment and centering 2 yearly Patient straps Replace straps 2 yearly Oil hoses Replace oil hoses 5 yearly Routine user checks programme The user of the equipment must establish a programme of routine user checks as detailed in the table below Normally the user will instruct the operator to perform these checks However it is for the operator of the equipment to ensure that all checks have been satisfactorily completed before using the equipment for its intended purpose Routine user checks may be carried out by the user Check Allura Xper FD20 series equipments Allura Xper FD20 series equipments All accessible parts of the stand and table All accessories All controls Brakes and wheels All indicators Cabling Table cleanliness Accessories Radiation shield s Reason Check for evidence of collision damage Check the condition of the spacer if fitted and the cable protective hoses ornamental hoses and ducting Check for collision damage Availability and integrity Ensure correct functioning Ensure correct functioning Ensure correct functioning Inspect for kinks and or cracks Hygiene and to ensure safe and optimum life of equipment To ensure that applicable accessories are fastened securely to the table especially the footrest Check for cracks o
92. oller to move table back Procedure selection in progress Please retry Ready for first Rotation scan Ready for second Rotation scan Ready to acquire mask run ALLURA XPER FD20 SERIES Action Meaning The maximum number of save positions was reached The last results saved will be overwritten Prefix emergency patient name Patient name is not supplied for new patient An internal error with a mini image occurred The maximum number of calibrations to be averaged was exceeded It is not possible to calculate an angle of horizontally placed lines Request to park the lateral stand Patient name part too long n a The pixelsize should be within specified boundaries n a n a n a Please wait while the system completes the action if it takes more than 20 seconds warm reboot the system n a The preferences file was corrupted Preferences files are used to store the last used values n a Procedure selection in progress when attempt to start X ray Ready for rotational angio definition run Ready for rotational angio replay run Ready to acquire mask run Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message Reduced speed due to Detector orientation Reference 1 Reference 2 Reference Biplane Release footswitch and park lateral st
93. ollision technology 8 13 Xper patient table 8 13 System definitions Acquisition examination 8 14 Doctor and nurse side of table 8 74 Terms as used in the manual 1 7 Type B symbol Definition applied part 8 10 1 2 Index ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems
94. on should be selected for viewing from the review folder The done list is a list of all finished examinations including the current acquisition examination The selected examination becomes the viewing examination There can be only one viewing examination at any time All review functions performed using the Review monitor operate on the viewing examination Unless a viewing examination other than the acquisition examination is explicitly selected all reviewing functions performed will be related to the acquisition examination Joystick directions Right gt Left gy Down 36260180 Dose related definitions Air Kerma AK Kinetic energy released in air by ionizing radiation The unit of kerma is the Gray Gy where 1Gy 1J kg Joules per kilogram Where Air Kerma is used in this manual the IEC defined Reference Air Kerma is meant Reference air kerma Air kerma expressed as an equivalent value at the interventional reference point Also known as skin dose Appendices 8 17 8 3 Glossary 8 18 Appendices 8 3 3 Air Kerma Rate AKR Air kerma per unit of time Dose Area Product DAP Product of the area of the cross section of an X ray beam and the averaged air kerma over that cross section The unit is the Gray square meter Gy m2 Dose Area Product rate DAP per unit of time Skin dose See Reference Air Kerma Interventional Reference Point IRP For interven
95. or serious injury and or damage to equipment Use of the Allura Xper FD20 series in an environment for which it was not designed can lead to fire or explosion Fire safety Use of an electrical product in an environment for which it was not designed can lead to fire or explosion Fire regulations for the type of medical area being used should be fully applied observed and enforced Fire extinguishers should be provided for both electrical and non electrical fires All operators of the Allura Xper FD20 series should be fully aware of and trained in the use of fire extinguishers and other fire fighting equipment and in local fire procedures Only use extinguishers on electrical or chemical fires which are specifically labelled for those purposes Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury If it is safe to do so attempt to isolate the Allura Xper FD20 series from electrical and other supplies before attempting to fight a fire This will reduce the risk of electric shocks ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Electromagnetic compatibility EMC 2 7 2 7 CAUTION ALLURA XPER FD20 SERIES Document version 3 0 Electromagnetic compatibility EMC The Allura Xper FD20 series complies with relevant international and national law and standards on Electromagnetic co
96. ormals files are used and there is an error in the title of the file The application could not read from a file The FONT section of the shared settings file is not correctly formatted This message is presented to the user if the application has problem reading the normals files Normals files determine the normal values for a population in Regional Wall motion analysis The REPORT section of the shared settings file is not correctly formatted The SETUP section of the shared settings file is not correctly formatted The SPREADSHEET section of the shared settings file is not correctly formatted The UI section of the shared settings file is not correctly formatted The version info in the header of the normals file is not correct Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document uersion 3 0 Displayed Message Error writing file ERROR Geometry configuration mismatch Exposure not possible Exposure not possible reselect application Exposure not possible Reselect procedure Exposure not possible emergency power active Exposure not possible image disk full Exposure not possible Not enough storage space Exposure not possible system problem Exposure not possible tube anode not at operating speed Exposure not possible Tube overload Exposure not possible tube rotor problem
97. ot be used for some time Product disposal 6 5 6 4 Fitting removing and disposing of batteries 6 6 Product disposal ALLURA XPER FD20 SERIES Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems 7 Technical data TF Specifications 7 3 7 1 1 Environmental requirements on OB ODER 7 3 Tal Rv te FUR Ret E e 7 3 Tile 7 4 Xray tubos NE IRR RETO TE REVUE rS 7 4 7 1 5 LCD monochrome and colour monitors 18 inch 7 5 7 1 6 LCD monitor ceiling suspension and actuator 7 5 7 5 70598 20808 7 6 I9 Imaging chain per channel sad e Depos 7 6 Peleo Beam Carrie n naa ha IQ Ore dU 7 7 IE Angie DIAGNOSE 7 9 7 1 12 Ceiling suspended radiation shield suse 7 10 7 1 13 Accessory bracket for ceiling suspended radiation shield 7 10 7 1 14 Contrast medium power injectors 7 10 la 7 11 7 1 16 Network 7 11 7 2 Stray radiation u EE huuu 7 12 7 2 1 Protection against stray radiation 7 12 72222 Stay radiation isokermd data seite 7 14 ALLURA FD20 series Document version 3 0 Technical data 7 1 Technical data 7 2 Technical data ALLURA XPER FD20 series Document uersion 3 0 9896 002 05471
98. ovement speed 6 cm s towards patient 9 cm s away from patient Longitudinal movement 300 cm 118 inch manual or motorized Motorized longitudinal movement speed optional 12 cm s outside working area 6 cm s inside working area Minimum ceiling height 297 cm 117 inch Technical data 7 9 7 1 Specifications 7 10 7 1 11 Neuro tabletop dimensions Cardio tabletop dimensions Technical data Xper Table Patient support Dimensions 3115 1250 e 440 190 s 1 560 1250 Figure 7 1 tabletop dimensions Maximum patient weight 250 kg Additional weight reanimation equipment 50 kg Maximum weight of all accessories total 25 kg Movements Lateral movement stroke 180 mm Lateral motorized movement maximum speed 150 mm sec 20 mm sec Longitudinal movement stroke 1200 mm Longitudinal motorized movement speed 150 mm sec 20 mm sec Height movement is always motorized Height movement stroke 785 1065 mm distance between upper side of tabletop and floor Height movement stroke with swivel applicable 865 1145 mm Height movement fixed speed 30 mm sec 2 mm sec Tilt movement is always motorized Tilt movement angle range 20 to 20 Tilt movement fixed speed 2 sec 0 2 sec ALLURA FD20 series Document version 3 0 9896 002 0
99. own Grabbing disabled image disk error System and error messages 4 11 4 1 Message and error handling 4 12 4 1 2 System and error messages Displayed Message WARNING Image disk error no storage possible WARNING Larc Collision Switch activated Warning Lateral geometry standposition unknown WARNING Limited image size due to rotated detector position WARNING low storage space 1 s exposures left WARNING Motorized movement not available WARNING No DAP measurement possible Warning position not reachable press footswitch or cancel WARNING Projection not reachable WARNING Radiation indication lamp defect WARNING Rotate Detector error move to landscape manually WARNING Shutters unavailable WARNING Wedges unavailable X ray not possible flat detector overheated X ray not possible system shutdown X ray not possible system shutdown X ray not possible tube defect XRes unavailable System messages Action Meaning Image disk error no storage possible The user is pointed out that there is a collision with the LArc The position of the lateral stand is unknown Flat detector is being rotated Low disk space allows storage of max x exposure images The motorized movement is not ready for use because it is malfunctioning or not present Area X ray dose not recorded call service n a Target projection not reachable during recall due to mechanical co
100. per FD20 series and of personal injury Introduction 1 9 1 6 Contra indications 1 10 Introduction 1 6 1 7 Contra indications This Philips Allura Xper FD20 series should not be used if any of the following contra indications exist or are thought to exist Special precautions must be taken and or caution must be exercised in the following cases Special consideration must be given to the protection of the embryo or fetus during radiological examination or treatment of women known to be pregnant Sensitive body organs e g lens of eye gonads must be shielded whenever they are likely to be exposed to the working beam Acute skin burns patients Acute hair loss patients Chronic radiation injury staff Training Users of this Allura Xper FD20 series must have received adequate training in its safe and effective use before attempting to operate the Allura Xper FD20 series described in this Instructions for Use Training requirements for this type of device will vary from country to country Users must make sure they receive adequate training in accordance with local laws or regulations If you require further information about training in the use of this Allura Xper FD20 series please contact your local Philips Medical Systems representative Alternatively contact the manufacturer at Philips Medical Systems Dept Corporate Industrial Policy and Technology P O box 10 000 5680 DA B
101. printed on film or paper or examinations saved to a file for Field Service examinations transfer to a remote network node examination deletion i e examinations not Scheduled Prepared or Completed or with origin Other examinations which are In progress user authentication security alerts i e secure node authentication failure or invalid certificate Field Service Field Service is used to enable the following configuration items based on information supplied by the hospital authentication and encryption time synchronization configuration of the Syslog server configuration of any other programs e g tools used to install certificates Certificates Certificate requests should be handled by the hospital T he hospital should decide on a procedure to create the Certificate request and import the certificates The hospital should also define the types of certificates required for example the certificate of the machine itself the certificates of the machines it chooses to trust the certificate of the Certificate Authority CA Certificates should always be signed by someone else i e no self signed are allowed However the signer of the certificate need not be present on the system Self signed certificates are the certificates required by the Integrating the Healthcare Enterprise IHE The following should also be specified the location of the cert
102. r acquisition Action Meaning Differences were detected in administrative items such as patient name run series date between the first loaded the ED or the ES image Do you really want a new acquisition selection n a n a n a n a n a n a n a n a Degraded image quality due to hospital emergency power Enter a calibration factor Enter corrections and select processing method Enter restrictions finish with double click The data in the INI file was not correct and the Analysis module used it s default values for the values it could not read The data in the SET file was not correct and the Analysis module used it s default values for the values it could not read n a Entry from other modality in worklist e g MR n a n a Selected examination can not be selected for reviewing Incorrect reviewing examination selected Examination already exists Examination is already selected for acquisition System and error messages 4 15 4 1 Message and error handling 4 16 System and error messages Displayed Message Exposure not possible FieldService user may not save QA report image Fluo grab not possible image disk full Fluo grab not possible system problem Fluoroscopy Fluoroscopy disabled due to max fluoroscopy time elapsed Fluoroscopy trace not possible FluoStore not available Image disk full For subtracted images use autocal or pixelsize cal Free
103. r tears fluoroscopy Maintenance Frequency Before the equipment is used Before the equipment is used Daily see note Daily see note Daily see note Daily see note Daily see note Daily see note Daily or as needed Daily Weekly 5 5 5 2 Routine user checks programme 5 6 NOTE 5 2 1 Maintenance Check Reason Frequency Inscriptions and labels Check for legibility Weekly Frontal C arm and Lateral ensure optimum life of equipment check Weekly ARC N that the tracks are free from dust grease or other particles XperCT user calibration To ensure optimum image quality Daily Visual and or audible checks during routine use Refer to Service documentation Beam limitation How to check the beam limiting device shutters Press the Frontal shutter joystick 11 on the Xper imaging module to reset the shutters Position the tabletop horizontally and adjust it to maximum height Position the C arm stand in the frontal position with the X ray beam perpendicular to the tabletop Position two lead rulers crosswise on the tabletop and use tape to attach the rulers Use the Frontal SID joystick 13 on the Xper geometry module to move the Flat Detector as close as possible to the rulers With the Detector fieldsize toggleswitch 1 on the Xper imaging module select an appropriate Flat Detector field size Initiate fluoroscopy by pressing footswit
104. racted position adjust the tabletop height as required perform CPR Safety 2 5 2 3 Electrical safety 2 3 Electrical safety WARNINGS Multiple portable socket outlets with insulation transformers Multiple portable socket outlets with insulation transformers are not to be placed on the floor If liquids are spilled on the multiple portable socket outlets there is a risk of electric shock hazard which can lead to serious or fatal injury to the patient and or damage to equipment Multiple portable socket outlets with insulation transformers that are part of the system including the Allura Xper FD20 series equipment are only to be used for equipments that are part of that system Connection to non approved equipment can lead to serious or fatal injury to the patient and or damage to equipment Multiple portable socket outlets with insulation transformer supplied with the system including the Allura Xper FD20 series equipment have been designed for a specified maximum load It is not permitted to connect other electrical equipment that is not part of the system including the Allura Xper FD20 series equipment to these multiple portable socket outlets The electrical safety of the Allura Xper FD20 series equipment cannot then be guaranteed and could lead to serious or fatal injury to the patient and or damage to equipment Non medical electrical equipment Non medical electrical equipment that is a part of the system i
105. re continuously monitored If a collision occurs the current will increase until it attains the calibrated threshold value The stand will then automatically back off from the object by a short reverse movement to clear the collision Reduced performance If the BodyGuard becomes defective stand movements are only possible at reduced speed Meanwhile a message is displayed on the Xper On Monitor Display of the Reference monitor and the Acquisition and Geometry Display of the Data monitor to alert the operator to this situation Xper patient table All the motorized table movements are monitored and controlled by the BodyGuard system on the C arm stand The BodyGuard sensors must kept dry otherwise the BodyGuard system will operate with reduced efficiency and the maximum speeds are limited to 8 s An audible warning is sounded during movement and a warning message is displayed on the Xper On Monitor Display on the Reference monitor xx and the Acquisition and Geometry Display on the Data monitor xx Collisions must be avoided as this can cause injury to the patient and or damage to the equipment The safety devices only operate if the stand and table are in a normal working position and normal projections are applied If other stand positions and projections are applied during operations a collision can occur while the moving part is out of range of a BodyGuard sensor or a collision sensor Such collisions must be avoi
106. room NOTE Monitor positioning in the monitor ceiling suspension can be freely configured i e not necessarily the order shown above For monoplane systems there will not be a Lateral ARC or lateral channel monitors and the frontal stand may be floor mounted or ceiling suspended Also there will be a three pedal Footswitch 1 2 About these Instructions for Use These Instructions for Use give a general system description for the Allura Xper FD20 systems 1 4 Introduction ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems About these Instructions for Use 1 2 ALLURA FD20 series Document version 3 0 Instructions for Use identification In order to identify the Instructions for Use and the system for which they are intended to be used a label has been placed on the Frontal stand The label indicates the following Type a unique code which identifies the kind of system as follows 722 003 Allura Xper FD10 722 005 Allura Xper FD10 10 722 006 Allura Xper FD20 722 008 Allura Xper FD20 10 and Allura Xper FD20 20 ON Order Number SN Serial Number The following illustration is an example of such a label note that each system delivered will have its own unique numbers Type 722 003 ON 100038492 SN 593 Figure 1 2 Label example Instructions for Use supplied with your system will be identified using the
107. s 1400 Watts at 230 V 1096 50 and 60 Hz X ray generators Velara CVFD microprocessor controlled 100 kW high frequency converter generator two generators for biplane systems Minimum exposure time of 1 ms Program selection Voltage range 40 kV to 125 kV Max current MRC GS 04 07 802 mA at 80 kV MRC GS 05 08 1062 5 mA at 80 kV Automatic kV and mA control for optimal image quality prior to run to safe dose Max continuous power for fluoroscopy 2 4 kW for 0 5 hour and 2 kW for 8 hours Nominal power highest electrical power 100 kW 1000 mA at 100 kV IEC 601 2 7 1987 Reference loading conditions 110 kV 18 mA continuous Pulsed X ray of 3 75 7 5 15 and 30 frames sec in monoplane and biplane mode for pulsed fluoroscopy Pulsed X ray of 0 5 to 6 frames sec for digital subtracted acquisition in monoplane and biplane mode Pulsed X ray up to 6 frames sec for digital acquisition in monoplane and biplane mode 15 and 30 frames sec optional Noise 55 dB A X ray tubes MRC GS 04 07 and cooling unit CU 3101 frontal Maximus ROTALIX Ceramic tube MRC GS 04 07 with anode heat storage capacity of 2 4 MHU and 0 4 0 7 mm nominal focal spot values maximal 30 and 67 kW short time load Grid switching at pulsed fluoroscopy Continuous loadability 3400 W at 21 degrees Celsius room temperature Dose management with SpectraBeam filtration with 0 2 0 5 1 mm CU eq ALLURA FD20 series Do
108. sa via the central service connection Verification test after remote service After certain remote service actions a verification test can become necessary When indicated by Service that a verification test is required the clinical user shall perform the test procedure as follows Under fluoroscopy conditions test the collimator wedges shutters for proper function Without X ray radiation test the movements of the table and the stand for proper function Test the system for proper behaviour as follows Set the stand to a vertical position On the table position a phantom lead rulers in the X ray beam area Maintenance 5 9 5 4 Anti viru s updates 5 10 Maintenance 5 4 NOTE 5 5 WARNING CAUTION Adjust the SID to 1 m 39 4 inches and select the smallest detector format Perform a fluoroscopy and check if the system behaviour is normal and the kV and mA values indicated on the AGD and the reference monitor are within the specified range Perform a digital cardiac or vascular exposure run and check if the system behaviour is normal and the kV and mA values indicated on the AGD and the reference monitor are within the specified range Anti virus updates The Allura Xper FD20 series system is equipped with anti virus software which is designed to detect viruses on your system and to deny access to infected files before they can do any damage Anti virus definitions should be updat
109. same labelling information Type ON and SN For CD s the label is attached to the front of the CD s case and for printed matter the label is attached to either the Front cover or rear of the title page Before using these Instructions for Use with your system ensure that the label situated on the Frontal stand and all the related materials supplied with the system are identified with the same labelling information This English language version of the Instructions for Use was originally drafted approved and supplied by Philips Medical Systems under the product part code Document number indicated on the rear of the Title Page The following table details the Instructions for Use that have been supplied with the Allura FD20 series system Instructions for Use IFU Product IFU this document User Interface Basic Operation Introduction 1 5 1 2 About these Instructions for Use 1 6 WARNINGS CAUTIONS Introduction NOTES Instructions for Use IFU Extended Operation Quantitative Analysis Accessories The combination of Instructions for Use detailed in the table above describes the most extensive configuration of the Allura Xper FD20 series with the maximum number of options and accessories Not every function described may be available on your product These Instructions for Use are intended to assist users in the safe and effective operation of the product described The user is consid
110. scription 8 1 Standards and regulations 82 Safety devices for stand and table movements 8 3 Glossary 8 4 EMC compliance 8 5 Abbreviations Standards and regulations The Philips equipment complies with all relevant national and international standards and laws Information on compliance with these standards will be issued on request by your Philips Medical Systems representative or by contacting Philips Medical Systems Dept Corporate Industrial Policy and Technology P O box 10 000 5680 DA Best The Netherlands Fax 31 40 27 63017 Measurement of technical parameters The following measurements are required in order to check compliance of the technical parameters of the system Appendices 8 3 8 1 Standards and regulations 8 4 Appendices Peak tube voltage during continuous fluoroscopy Direct kVp measurements should never be made with the HV dividers normally supplied to field service T he kVp is factory calibrated for FDA compliance The must be measured with a digital voltmeter connected to measuring points EH X3 AV HV and EH X30 GND at pcb DIG kV mA where 1 V equals 20 kVp Peak tube voltage during radiography cine fluorography and pulsed fluoroscopy Direct kVp measurements should never be made with the HV dividers normally supplied to field service The kVp is factory calibrated for FDA compliance The must be measured with an oscilloscope connected to measuring points EH X3
111. sensitive layer inside the Image Detector For the FD20 the Receptor Correction is 10 mm Point Of Interest POI and IsoCenter The POI Height is the height of the Point Of Interest in the patient relative to the surface of the tabletop The POI Height Offset is the deviation in height of the Point Of Interest in the patient relative to the Beam IsoCenter but possibly shifted longitudinal along the tabletop surface and or lateral horizontal The POI Height Offset changes when the tabletop is moved up or down When the Point Of Interest in the patient is higher than the Beam IsoCenter in case there is no longitudinal or lateral offset the POI Height Offset 0 Appendices 8 23 8 3 Glossary Likewise the POI Longitudinal Offset is the deviation in longitudinal direction of the patient The POI Longitudinal Offset changes when the tabletop is moved longitudinal and when the X ray beam is moved longitudinal When the X ray beam is moved towards the patient s feet the POI Longitudinal Offset gt 0 The POI Lateral Offset is the horizontal deviation lateral to the patient The POI Lateral Offset changes when the tabletop is moved lateral When the patient is moved to his her right direction the POI Lateral Offset gt 0 Beam IsoCenter Point of Interest Height Offset Point of Interest Point of Interest Height Point of Interest Longitudinal Offset Beam IsoCenter Point of Interest Height Offset
112. t Detector than with the conventional Image Intensifier TV Fluoroscopy imaging in steep angles and rotations i e Spider view is improved with the dynamic Flat Detector ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Safety devices for the stand and table movements 8 2 ALLURA XPER FD20 SERIES 8 1 5 8 2 WARNING NOTE Document version 3 0 Typical Air Kerma For typical data see Addendum Reference Air Kerma rate for Allura Xper FD20 series Safety devices for the stand and table movements A During execution of both manual and motorized movements of the C arm Lateral ARC or the table the operator is responsible for the safety of patient staff and equipment The operator must avoid collisions in order to prevent serious injury to patient and staff or damage to the equipment The system is provided with several safety devices to help the operator avoid collisions and carry out the appropriate movements See also the Allura Xper FD system Basic Operation Instructions for Use section BodyGuard and collision switch protection The safety features apply to motorized movements only The system is provided with the following safety features dead mans principle bodyguards collision switches balanced movements slip clutches soft collision technology reduced performance
113. t it is not reliable The frontal stand can collide with the Biosense amp equipment mounted under the tabletop because the X ray tube cover BodyGuard sensor is not sensitive to the Biosense equipment Collision switches The collision switches on the Lateral ARC will detect a collision and stop motorized movements to prevent injury to the patient and personnel or damage to equipment Collision switches are not active when the Lateral ARC is in the parked position Collision switches are switched OFF when the Collision Override Mode function is active It is the responsibility of the operator to ensure that the stand will be moved away from the collision situation Balanced movements If movement ofa device is balanced e g the stand rotation movement it can be carried out manually ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Safety devices for the stand and table movements 8 2 WARNINGS ALLURA XPER FD20 SERIES Document version 3 0 Slip clutches Slip clutches are provided between motor and drive They only operate in balanced movements If a collision occurs and the motor keeps running the clutch starts slipping thus limiting the collision impact Soft collision technology The maximum motor current is calibrated to be just greater than that required for normal movement During operation all motor currents a
114. ted if a scheduled patient record is selected for Acquisition at the Data monitor ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA XPER FD20 SERIES Document version 3 0 The examination attributes for that examination are derived from the selected scheduled patient record and the physician record belonging to that scheduled patient record acquired runs both exposure and grabbed fluoro are stored in the acquisition file of the selected acquisition examination If an acquisition examination has no patient name present the system will create one automatically with the patient name NO NAME Examination An examination consists of a number of examination attributes such as patient name examination ID and examination date all entered by the operator in an examination schedule and a number of exposure runs When an examination has been scheduled for acquisition images can be acquired and will be collected in a file for that examination Examination report The Report examination function allows the operator to print AK DAP and examination information concerning the acquisition examination on a locally connected printer Printing is a background process and the next acquisition examination can be selected as soon as the print process has been started Exposure run An exposure run consists of a number o
115. tine user checks programme Gene tete ene hoa 5 5 9 9 7 R moteservicena sone MA Nep Qu ions asi m e FO e i paid 5 8 54 Anti virus updates coti Davide t es er HR 5 10 5o Cleaning and disinfection tes Ree aA Mna UE 5 10 Product disposal ee es 6 3 ume 6 3 6 2 Passing the Allura FD20 series system on to another user 6 3 6 3 Final disposal of the Allura Xper FD20 series system 6 4 6 4 Fitting removing and disposing of batteries 6 5 Technical data uud ufi duin e aeneae 7 3 Fake Specifications 7 3 742 SEA Pad tation asado doa uade od ove o eit 7 13 Appendices e i e Te ERREUR doeet 6 3 8 0 ntr duction 25 8 3 8 1 Standards and regulations o uoo ettet terrere ton 8 3 8 2 Safety devices for the stand and table movements 8 11 8 3 Glossary sacia aiii i d enden lun Rec ERU FEBR a nad 8 14 8 4 EMC compliance NE du eed 8 29 8 5 Abbreviations 8 34 LLL 1 1 ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 3 0 Introduction 11 About the Allura FD10 series 1 2 About these Instructions for Use 1 3
116. tional X ray equipment specified point on the reference axis used as a reference location for the indication of patient incident air KERMA and air kerma rate Geometric terms Geometric term Angulation ANG Anterior Posterior AP Posterior Anterior PA Caudal CAUD Cranial CRAN Frontal Height Isocenter Lateral Explanation Movement in the longitudinal plane of the patient from head to feet or vice versa Angulation clockwise is denoted as positive or plus With the patient is in a supine position is when the X ray tube is above the patient PAis when the X ray tube is under the patient The imaging device is angulated in the direction of the patient s feet with patient in head to stand position i e positive angulation The imaging device is angulated in the direction of the patient s head i e negative angulation Direction of the X ray beam perpendicular to the patient in the vertical plane Direction perpendicular to the patient in the vertical plane Point in space around which both the rotation and angulation movements occur Direction of the X ray beam perpendicular to the patient in the horizontal plane ALLURA XPER FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA FD20 series Document version 3 0 Geometric term Explanation Left Anterior X ray beam perpendic
117. to restrict access to the system to authorized users only customisable on off a user log on log off procedure is required to gain access to the system access to the system is granted according to a customisable list of authorised users aseparate list of user accounts is included but which is not integrated with the Xper settings physician list Appendices 8 7 8 1 Standards and regulations 8 8 Appendices Audit trail Required to log user activities which are information security critical applies to logging on reading and or modifying clinical information requires that means be provided for auto backup on a hospital server e g the use of an external standard Syslog server Network time synchronization Intended to synchronize system time to an external time standard uses a standard Network Time Protocol the coupling is configured by Field Service during system installation Security and node authentication Intended to secure the exchange of clinical data and restrict this exchange to pre determined nodes Applies to RIS CIS and PACS nodes e g archives and viewers does not apply to e mail data e g clinical reports sent via e mail does not apply to Field Service access uses standard Transport Layer Security Protocol the user can decide at installation to use encryption this may result in reduced performance Computer systems cannot be guaranteed to be safe in
118. ts line is too short the algorithm is not able to calculate the result Close the printer door The requested medium is not on stock n a Automation Job failed AutoArchive or AutoExport The connection failed due to network or DICOM problems Something wrong on protocol level The system is configured wrong Invalid or corrupt data objects The data repository is not accessible Data objects not found or locked A data object is not supported by the repository and therefore skipped A data object is rejected by the repository e The job contains invalid parameters The user is pointed out that the BodyGuard at the tube that limits the speed of the CArm or Propeller to very low speed if overridden X ray tube overload Tube is in overload during exposure The projection of the selected image is unknown Reported when the Frontal Stand has lost the stored adjustment data ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Message and error handling 4 1 ALLURA XPER FD20 SERIES Document version 3 0 Displayed Message WARNING Area AK R measurement not recorded WARNING Bodyguard defect move at own risk WARNING Bodyguard dirty move at own risk WARNING Bodyguard very dirty clean sensor Warning Chemicals low WARNING collimator communication defect WARNING WARNING collimator general d
119. uces users responsibilities for sound clinical judgment and best clinical procedure The Allura Xper FD20 series is intended for Dedicated vascular and neurovascular imaging applications including diagnostic and interventional procedures This includes e g peripheral cerebral thoracic and abdominal angiography as well as PTCAs stent placements embolisations and thrombolysis Cardiac imaging applications including diagnostics interventional procedures such as PTCA stent placement and atherectomies pacemaker implantations and electrophysiology e Non vascular interventions such as drainages biopsies and vertebroplasties procedures Use of the Allura Xper FD20 series system in the OR environment is restricted the system should not be used for surgery applications only for endo vascular procedures ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Compatibility 1 5 ALLURA XPER FD20 SERIES CAUTION 1 5 WARNING Document version 3 0 Installation use and operation of this Allura Xper FD20 series is subject to the law in the jurisdiction s in which the Allura Xper FD20 series is being used Users must only install use and operate the Allura Xper FD20 series in such ways as do not conflict with applicable laws or regulations which have the force of law Uses of the Allura Xper FD20 series for purposes ot
120. ue has to be corrected by subtracting the current flowing via the measuring divider resistor by the following expression I kV 2xR where the value R of the divider resistor is equal to 100Mohms for non GS tubes and 70Mohms for GS tubes The average tube current Ipulsed fluoro is calculated by means of the expression divider resistor divider resistor pulsed fuoro X t x f where I electrical current A t exposure time s and f frequency Hz Exposure time The exposure time is measured with an oscilloscope connected to measuring points EH X3 AV HV and EH X30 GND at pcb DIG kV mA where 1 V equals 20 kVp The exposure time is the time during which the measured kV remains equal to or greater than 75 of the maximum value Appendices 8 5 8 1 Standards and regulations Velara Upper jack Oscilloscope 12 kOhm L jack OWEE had mAs 10nF plug Chassis GND of chassis mAs Measured with a digital mAs meter connected instead of the mAs plug onto EG 100 The measured mAs value must be corrected with the mAs product of the current flowing via the measuring divider resistor by the following expression MAS L divider X Exposure time Indicated values and readings are accurate within the following limits Parameter Range Accuracy kV continuous fluoroscopy 40 110 kV lt 3 kV cine fluorography 40 12
121. ular to the longitudinal axis of the patient with the Oblique LAO imaging device on the left side of the patient i e positive rotation Longitudinal Direction of a movement in the horizontal plane parallel to the longitudinal axis of the patient Rotation ROT Movement around the longitudinal axis of the patient Clockwise rotation is denoted as positive or plus Right Anterior X ray beam perpendicular to the longitudinal axis of the patient with the Oblique RAO imaging device on the right side of the patient i e negative rotation Source Image Distance between the X ray tube focus and the input screen of the Distance SID imaging device Transversal Direction of a movement in the horizontal plane perpendicular to the longitudinal axis of the patient Patient orientation Patient orientation refers to the position of the patient on the table and the direction of the X ray beam The displayed angle information is patient oriented This means that the patient orientation stand rotation angulation and L arm position are all taken into account when displaying the angle information Angle information Angle information is displayed on the On Monitor Display OMD of the Reference monitor and at the Acquisition and Geometry Display AGD of the Data monitor The displayed angle titles depend on the system configuration cardiac or vascular which is EPX customization defined Cardiac Vascular Rotation LAO Rot RAO
122. with the system Technical data 7 11 7 1 Specifications 7 12 Technical data 7 1 15 7 1 16 NOTE Storage media Xcelera DICOM Recorder Refer to the Xcelera DICOM Recorder Instructions for Use Network data Xper DICOM image interface Maximum Ethernet transfer speed see note 100 Mbit s Transfer speed for images see note 2 Mbyte s RIS CIS DICOM interface Maximum Ethernet transfer speed see note 10 Mbit s Transfer speeds mentioned above depend on the local situation network load and external station ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Stray radiation 7 2 7 2 Stray radiation 7 2 1 Protection against stray radiation Technique factors 110kV 3600 mAs no additional filter Scatter object 25 x 25 x 10 cm water equivalent material according to IEC 601 1 3 clause 29 208 6 Height above floor 200 180 160 140 120 100 80 60 40 20 0 s With 19 10 Without 19 protective device protective device Figure 7 2 Technique factors graph ALLURA XPER FD20 series Document version 3 0 Air kerma in one hour uGy Significant zone of occupancy Protective device with 0 5 1 0 or 1 5 mm Dimensions in centimetres Technical data 270020 36 7 2 Stray radiation NOTE As you ca
123. without a proper awareness of how to use it safely could lead to fatal or other serious personal injury It could also lead to clinical misdiagnosis clinical mistreatment Adequate training Do not use the Allura Xper FD20 series for any application until you have received adequate and proper training in its safe and effective operation If you are unsure of your ability to operate this Allura Xper FD20 series safely and effectively DO NOT USE IT Operation of this Allura Xper FD20 series without proper and adequate training could lead to fatal or other serious personal injury It could also lead to clinical misdiagnosis clinical mistreatment Do not operate the Allura Xper FD20 series with patients unless you have an adequate understanding of its capabilities and functions Using this Allura Xper FD20 series without such an understanding may compromise its effectiveness and or reduce the safety of the patient you and others For information about training please refer to Training in the Introduction section of this manual ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Emergency procedures 2 2 WARNINGS 2 2 WARNINGS ALLURA XPER FD20 SERIES Document version 3 0 Safety devices Never attempt to remove modify override or frustrate any safety device on the Allura Xper FD20 series Interfering with safety d
124. xposure run cannot be started A guidance message is generated to indicate this fact If any of the following warning messages is displayed during an examination carry out the required action Displayed message Action WARNING less than 1000 images can be Remove patients and or examination folders stored WARNING low storage space 1 s exposures Remove patient and or examination folders left WARNING Possibly not enough free disk space Delete not used examinations to make some disk space If the last of these three messages is displayed for the first time the examination can be finished Before starting a new examination delete or unprotect examinations in order to make more space Free disk space can be obtained in the following ways Automatically When a new acquisition examination is selected the system will try to obtain enough disk space for this examination This is done by deleting old examinations that have been archived and have not been manually protected ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems Glossary 8 3 ALLURA XPER FD20 SERIES 8 3 2 Document version 3 0 Manually The operator may delete old examinations at any time This will make free disk space available that was used by those examinations Viewing examination To review an examination other than the acquisition examination an examinati
125. y isolate this Allura Xper FD20O series from the mains electrical supply before cleaning disinfecting or sterilizing it Equipotential ground connection An equipotential ground earth connection point is provided This Allura Xper FD20 series may only be used in areas meeting local standards for electrical safety in rooms used for medical purposes such as the US National Electrical Code International Electro technical Commission IEC also gives guidance on equipotential ground earth connection points Mechanical safety Do not remove covers from the Allura Xper FD20 series unless expressly instructed to do so in this Instructions for Use Moving parts are present within the Allura Xper FD20 series Removing covers could lead to serious or fatal personal injury Covers should only be removed by qualified and authorized service personnel In this context qualified means those legally permitted to work on this type of medical electrical product in the jurisdiction s in which the product is being used and authorized means those authorized by the user of the product Safety 2 7 2 5 Explosion safety 2 8 2 5 WARNINGS 2 6 WARNING Safety Explosion safety Do not use the Allura FD20 series in the presence of explosive gases vapours such as certain anaesthetic gases Do not use flammable or potentially explosive disinfecting sprays The resultant vapour could ignite causing fatal
126. ystem Basic operation Instructions for Use section Switching the system ON OFF ALLURA FD20 series Document version 3 0 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES Document version 1 2 Maintenance 5 1 5 2 219 5 4 5 5 Planned maintenance programme oues aaa 5 3 Routine user checks programme eie prends 5 5 Ded Beam TIE OI RO DATA NR TUAE 5 6 Remote SERVICE n ananassa 5 8 Antivir s oo oce E E de o eds 5 10 Cleaning disinfection eerta p RD aot atate 5 10 Fendt 5 11 5522 Disinfection sso dite one aie madonna 5 11 Maintenance 5 1 Maintenance 5 2 Maintenance ALLURA XPER FD20 series Document uersion 1 2 9896 002 05471 Philips Medical Systems 9896 002 05471 Philips Medical Systems ALLURA XPER FD20 SERIES 5 0 NOTE 5 1 WARNING Document version 3 0 Maintenance Introduction To ensure satisfactory operation the Philips Allura FD20 series requires periodic planned maintenance and routine user checks These are essential to keep the equipment operating safely effectively and reliably Planned maintenance may only be carried out by qualified and authorized service technicians In this context qualified means those qualified to work on this type of medical electrical equipment in the jurisdiction in which the equipme

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