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USER'S MANUAL

General instructions for use

(Rev. 0)

I-Max Touch (110-120V)

101

6.10.3.5 E362 - X-ray button released during examination

NOTE:

The X-ray button has the so-called "dead man’s switch" function, i.e. it
must be kept pressed for the whole time of the examination,

also during

the phases of the examination with emission interruption

(for

instance, in open/close mouth TMJ).

This message signals that the button was released during the

examination phase; the motors are unlocked, therefore the patient can
get out of the system. Repeat the system centring phase and repeat the
examination.

Содержание I-Max Touch

Страница 1: ...Version 25 September 2009 Rev 0 I Max Touch 0459 110 120V version User s Manual...

Страница 2: ...urve of the anode 21 5 3 Applied safety regulations 23 5 4 Note on constant magnification for Panoramic and TMJ mouth open closed examinations 24 5 5 Measurement method of technical factors paragraph...

Страница 3: ...4 1 Preparation of the patient 66 6 6 4 2 Carrying out the second exposure mouth open 68 6 7 SINUS examination 71 6 7 1 Anatomic Manual Exposure 72 6 7 1 1 Anatomic exposure 73 6 7 1 2 Manual exposur...

Страница 4: ...ode E850 E852 103 6 10 6 1 E850 One or more keys appear to be pressed on start up 103 6 10 6 2 E851 Column key pressed 103 6 10 6 3 E852 Key Patient Entrance pressed during the movement103 6 11 Resear...

Страница 5: ...USER S MANUAL Contents I Max Touch 110 120V Rev 0 iv THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 6: ...vailable in high resolution and normal resolution high speed modality CEPH exam in different formats CARPUS exam The aim of this publication is to instruct the user on the safe and effective use of th...

Страница 7: ...V Rev 0 2 1 1 Icons appearing in the manual This icon indicates a NOTE please read the items marked by this icon thoroughly This icon indicates a WARNING the items marked by this icon refer to the saf...

Страница 8: ...uch different from the intended use damage to the unit the operator or the patient caused both by installation and maintenance procedures different from those described in this Manual and in the Servi...

Страница 9: ...l regulations and in particular with the IEC 60601 1 2 regulation it is advisable to install it at a certain distance from electrical energy transformation chambers from Uninterruptible Power Supply U...

Страница 10: ...of radiography It is advisable to control the X ray emission from a protected area by means of a remote control If it is necessary to operate near the patient stay as far as the remote control cable...

Страница 11: ...e openings of laser centring devices with tools that could modify the optics Any cleaning must be performed only by authorised technicians Operations other than those indicated could cause the ejectio...

Страница 12: ...it must be disposed of at the appropriate disposal centres In particular the device contains the following materials and or components Tube head dielectric oil lead copper iron aluminium glass tungste...

Страница 13: ...of its parts the device contains materials and liquids that at the end of the lifespan of the unit must be disposed of at the appropriate disposal centres A C N Connection point to the neutral conduct...

Страница 14: ...mild detergent to clean the painted surfaces the accessories and the connection cables and then wipe with a dry cloth do not use corrosive abrasive solvents alcohol benzine trichloro ethylene The dis...

Страница 15: ...USER S MANUAL Description I Max Touch 110 120V Rev 0 10 4 DESCRIPTION 4 1 Identification labels and laser labels 4 3 6 7 1 8 2 5...

Страница 16: ...h identification label 2 Tube head identification label 3 CEPHALOMETRIC device identification label 4 PANO Digital Sensor identification label 5 PANCEPH Digital Sensor identification label 6 N 2 Spot...

Страница 17: ...m 4 2 1 Basic version The basic version enables to perform the following examinations Panoramic Adult or Child with 3 Sizes and 3 Types of Biting for a total of 18 combinations in Automatic selection...

Страница 18: ...e secondary collimator and the Digital Sensor inside the relative sensor holder is automatic according to the selected format projection The Soft Tissues Filter is motorized to obtain the best possibl...

Страница 19: ...standard device Rated line voltage 110 120 V Line frequency 50 60 Hz Maximum line current 15 A 115 V 50 60 Hz Power consumption 1 7 kVA 115 V 50 60 Hz Protection fuse F1 15 A T Protection fuse F2 of s...

Страница 20: ...Minimum 4 5 s 18x22 nR maximum 15 s 30x22 hR Exposure time accuracy 10 Examination modes Examination selection Automatic selection for Adult and Child 3 Sizes 3 biting modes in Panoramic Manual selec...

Страница 21: ...8 Maximum anodic current 12 mA Anodic current accuracy 10 Duty cycle 1 16 Nominal power 1 032 kW 86 kVp 12 mA Total filtration 2 5 mm Al eq 70 kVp HVL Half value layer 3 1 mm Al eq 86 kVp Transformer...

Страница 22: ...please refer to relevant paragraphs for detailed explanation Wave length 650 nm Divergence 12 5 mRad Optical power on the working surface 0 5 mW Laser class Class 1 according to IEC 60825 1 A1 A2 DNRO...

Страница 23: ...78 7 with CEPH Recommended room size please refer to the Service Manual 130x140 cm 51 2 x55 1 without CEPH 160x222 cm 63 x86 6 with CEPH Maximum working temperature range 10 40 Relative working humidi...

Страница 24: ...cal characteristics Rev 0 I Max Touch 110 120V 19 5 1 Dimensions 1260 49 60 1040 40 95 905 35 63 1755 69 10 1600 63 00 2450 96 46 1009 39 74 1140 44 88 with free standing base Figure 3 I Max Touch dim...

Страница 25: ...Rev 0 20 1260 49 60 1040 40 95 905 35 63 1755 69 10 1600 63 00 2450 96 46 1009 39 74 927 36 50 1777 69 96 1910 75 20 1140 44 88 with free standing base 1970 77 56 with free standing base Figure 4 I M...

Страница 26: ...USER S MANUAL Technical characteristics Rev 0 I Max Touch 110 120V 21 5 2 Loading curve of the tube and cooling curve of the anode Tube CEI OPX 105 0 5 IEC 60336 Load Anode cooling curve...

Страница 27: ...USER S MANUAL Technical characteristics I Max Touch 110 120V Rev 0 22 Tube head heating and cooling curve 0 50 100 150 200 250 300 350 400 0 100 200 300 400 500 600 min E kJ...

Страница 28: ...1 1 4 1996 A1 1999 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 Electromagnetic compliance IEC 60601 1 2 2001 Protection against radiation IEC 60601 1 3 1994 IEC 60825 1 1993 A1 1997 A2...

Страница 29: ...Max Touch follows a rototranslation path which maintains constant the magnification factor stated in the Technical Characteristics of each type of exam along this standard shape only along the dentiti...

Страница 30: ...during the initial phase and increased on the canine incisor zone in order to compensate the effect of greater attenuation owing to the spine The value displayed during the panoramic examination corre...

Страница 31: ...kV meter The procedure to measure the exposure parameters by a non invasive kV meter is the following 1 With the unit switched ON be either in Anatomic or Manual mode press the Anatomic Manual mode i...

Страница 32: ...Table 1 4 Perform an exposure technical factors can be read on the measuring instrument NOTE The performance is guaranteed only if the measurement of kV and time is done with the invasive method due...

Страница 33: ...e following pages Figure 5 WARNING The USB port on the keyboard MUST NOT be used with an external Hard Disk with own mains connection It has to be used only with USB Pen Drives Light signalling X rays...

Страница 34: ...e details on each functional area are provided in the following pages Figure 6 WARNING The USB port on the keyboard MUST NOT be used with an external Hard Disk with own mains connection It has to be u...

Страница 35: ...tric The other two identified by the arrows help navigate within the exams of each mode It is possible to select the anatomic mode examinations anatomic selection using prefixed exposure values This k...

Страница 36: ...ified exposure parameters can be stored or exposure verification tests can be performed There are two light indicators the first one on the top indicates the condition Machine Ready indicating the use...

Страница 37: ...onnector of the control panel it writes the acquired image that is stored in the memory of the unit on the pen drive that is inserted When this key is green the pen drive is recognised has enough free...

Страница 38: ...llision with patient or in case of release of rays button Repositioning the rotation group to bring the group to the initial position after the examination and to exit from the making an exposure mode...

Страница 39: ...cates operative messages warnings and exposure parameters Other 18 USB Pen Drive key 19 Return to control panel main menu USB port to connect a pen drive Acquired image display Image displays the last...

Страница 40: ...sively displayed on the screen adjusted to have the whole image in the screen During this processing step zoom keys are not displayed As soon as the image is acquired and fully processed it is display...

Страница 41: ...mage the pen drive key 18 on the screen will be displayed in red Please verify that there is enough free space on the pen drive if not please free up at least 25 MB of space Please verify that the pen...

Страница 42: ...resent The I Max Touch control system takes care of checking the consistency of the safety measures that allow for the correct use of the digital sensor in particular To prevent the acquisition in cas...

Страница 43: ...all parts to a position suitable for the execution of a safe and stable contact In order to insert the sensor in the desired station carry out the following operations 1 Grip the sensor by the approp...

Страница 44: ...so that the whole mobile system retracts and the electronic connectors and the reference plugs are completely released 2 Grip firmly the handgrip and move towards the upper part of the digital sensor...

Страница 45: ...ries of checks which in the event of negative result could require the intervention of the technician The only problem that can be solved by the user is related to the position of the PAN sensor holde...

Страница 46: ...raphic in the button MEDIUM SIZE with the display of the corresponding graphic in the button STANDARD DENTITION with the display of the corresponding graphic in the button and the display shows for in...

Страница 47: ...all the people who can assure a tight grip on the centring bite The appendix for edentulous patients must be applied only for patients who cannot assure a tight grip on the bite or are not co operati...

Страница 48: ...e arm carries out a scanning towards the support column The X rays are emitted only when the rotating arm is at constant rotation speed The patient s centring is assisted by two linear luminous laser...

Страница 49: ...onding graphic in the button STANDARD DENTITION with the display of the corresponding graphic in the button and the display and graphic showing the default exposure parameters if this is the first pan...

Страница 50: ...ular joint the examination is performed with the same trajectory of the standard Panoramic by reducing the rays emission time This examination is used for instance during the treatment continuation ph...

Страница 51: ...the dentomaxillofacial complex that it is assumed as standard The I Max Touch follows a rototranslation path which maintains constant the magnification factor stated in the technical characteristics...

Страница 52: ...ible to choose between the following two operating modes ANATOMIC with the values of kV and mA programmed on the basis of the type of patient and the size MANUAL with the possibility to vary the kV an...

Страница 53: ...the display will visualise the kV and mA settings as in the table Exposure values in PAN mode Adult Patient 13 8 seconds Child Patient 13 4 seconds kV mA kV mA Small 68 6 64 6 Medium 72 6 66 6 Large 7...

Страница 54: ...nd the up and down arrow keys of the parameters 3 and 4 and the Anatomic Manual mode indicator will display M The display will show respectively one of the following two indications x x k V x x m A x...

Страница 55: ...tioning 1 2 3 4 45 46 Figure 9 Legend positioning devices and patient centring 1 Panoramic chin rest 2 Centring bite 3 Temple clasps Forehead support 4 Temple clasps Forehead support release knobs 45...

Страница 56: ...tient to bite the reference notch of the bite with his incisors Figure 9 In case of edentulous patients he she must rest the chin against the reference shoulder of the edentulous chin support 5 Instru...

Страница 57: ...eep a correct position bring also the forehead support close to the patient s forehead and ensure that in this phase the patient has not changed position 9 Press the key Patient Entrance 6 to confirm...

Страница 58: ...If the operator is not protected by suitable screens he must stand at least 1 5 m 4 9 ft away from the emission of the rays see the Figure 1 and Figure 2 1 Verify once again that the exposure data are...

Страница 59: ...e exposure 2 Once the exposure is completed the system will rotate back When it has completed this movement the display shows the message P A T I E N T E X I T P R E S S 0 and it will be necessary to...

Страница 60: ...or the machine collides with the patient himself or with any object or you realise that the parameters set are not correct you must release the X ray button immediately interrupting the emission of X...

Страница 61: ...ave the effect of compensating the higher absorption of X ray in the zone of the spinal column As an example the variation of the parameters follows the curve below Set value Actual value mA Actual va...

Страница 62: ...onal movements The 4 images represent the right and left condyle of the temporo mandibular arch TMJ with closed mouth and open mouth The position of the images couples the images corresponding to the...

Страница 63: ...J exposure or the exposure parameters kV and mA of the last exposure performed For example 7 2 k V 0 6 m A 9 7 0 s T M J O C C L O S E Once the settings have been completed the chin support must be pl...

Страница 64: ...ion 10 After setting the machine it is possible to choose between the following two operating modes ANATOMIC with the values of kV and mA programmed on the basis of the type of patient and the size MA...

Страница 65: ...key small medium large On the basis of the selections made the display will visualise the kV and mA settings as in the table Exposure values in TMJ examination 9 7 sec Examination Adult Child TMJ mou...

Страница 66: ...ppear orange frames will appear around the up and down arrow keys of the parameters 3 and 4 and the Anatomic Manual mode indicator will display M The display will show respectively one of the followin...

Страница 67: ...sure that it does not interfere with the trajectory of the X ray beams 3 Place the patient in a standing position at the SINUS TMJ chin support With the keys Column movement 15 16 lift lower the colu...

Страница 68: ...r NOTE The laser centring device will stay lit up until the Centring Devices ON 14 key or at the end of the alignment the key Patient Entrance 6 is pressed to start the exposure 7 Close the temple cla...

Страница 69: ...all the movements made during the examination but without emitting rays The test function of the TMJ closed open mouth is the same as for the panoramic mode and so there will not be a second rotation...

Страница 70: ...it pressed until the end of the exposure The X ray emission to the central part of the dental arch is suspended during the examination phase so the relative signals sound and visual are therefore als...

Страница 71: ...ed x x k V x x m A 9 7 0 s T M J O C O P E N x value defined by the settings 3 Position the patient again if he has been removed from the centring device Tell him to open his mouth helping him to keep...

Страница 72: ...am as in Figure 13 The movement of the patient head due to the open mouth positioning is automatically corrected by the software and should be not necessary any column adjustment NOTE The laser centri...

Страница 73: ...t the system is still aligned with the patient s sagittal medial plane 1 Press the key Patient Entrance 6 The display will show x x k V x x m A 9 7 0 s S T A R T E X A M Check again that the exposure...

Страница 74: ...al part of the dental arch is suspended the relative signals sonant and visual are also suspended 2 Once the exposure is completed the system will rotate back When it has completed this manoeuvre the...

Страница 75: ...R E S S 0 All the motors will switch off and it will be possible if necessary to manually rotate the arm allowing the patient to come out it is recommended that this movement be made with great care i...

Страница 76: ...NUS examination press key Examination Mode Selection 10 until the following message and graphic is displayed x x k V x x m A 9 4 0 s S I N U S x value defined by the settings During the examination on...

Страница 77: ...ion 10 After setting the machine it is possible to choose between the following two operating modes ANATOMIC with the values of kV and mA programmed on the basis of the type of patient and the size MA...

Страница 78: ...ent with the Adult Child key 7 Select the type of build with the Size 8 key small medium large On the basis of the selections made the display will visualise the kV and mA settings as in the table Exp...

Страница 79: ...will disappear orange frames will appear around the up and down arrow keys of the parameters 3 and 4 and the Anatomic Manual mode indicator will display M The display will show respectively one of th...

Страница 80: ...lace the patient in a standing position at the SINUS TMJ chin support With the keys Column movement 15 16 raise lower the column until the chin support rest is aligned with the patient s chin 4 Positi...

Страница 81: ...eight this can be adjusted by means of the laser knob on the side of the mirror NOTE The laser centring device will stay lit up until the Centring Devices ON 14 key or at the end of the alignment the...

Страница 82: ...g the key Test 5 to activate the Test function In this condition it will be possible to make the machine perform all the movements made during the examination but without emitting rays Once the cycle...

Страница 83: ...t pressed until the end of the exposure During the examination the emission of rays in correspondence with the central part of the dental arch is suspended the relative signals sonant and visual are a...

Страница 84: ...es with the patient himself or with any object or you realise that the parameters set are not correct you must release the X ray button immediately interrupting the emission of X rays and the movement...

Страница 85: ...Soft Tissues Filter STF this filter reduces the dose in areas with low bone content and highlights the patient s profile which under normal conditions would be overexposed and so not visible The I Ma...

Страница 86: ...he temple clasps These operations are necessary to prevent interference with the rays beam and with the panoramic sensor holder when the arm is being positioned WARNING Neither of the two messages are...

Страница 87: ...he sensor in CEPH position folloing instruction in paragraph 6 2 and wait some seconds before to press Patient Entrance 6 key NOTE In case of a double sensor unit once the alignment is completed the f...

Страница 88: ...nning time is lower in Normal Resolution this allows you to give the patient a smaller dose yet still obtaining an image of sufficient quality for the orthodontic diagnostics albeit with a spatial res...

Страница 89: ...which is modified by pressing the same key again After setting the machine accordingly the following two operating modes may be selected ANATOMIC with the kV and mA values programmed according to the...

Страница 90: ...of build with the Size 8 key small medium large The kV and mA values will be displayed according to the selections made as per the following tables Adult Child kV mA kV mA Small 66 6 62 6 Medium 70 6...

Страница 91: ...Examination mode selection the Adult Child Selection 7 and the Size selection 8 will disappear orange frames will appear around the up and down arrow keys of the parameters 3 and 4 and the Anatomic M...

Страница 92: ...g device itself Move the nose rest Figure 15 away outwardly to its maximum extension Manually rotate the craniostat group according to the cephalometric projection to be made moving the upper part of...

Страница 93: ...graph 6 8 2 Advise the patient to remain still and to keep his mouth closed with the teeth touching throughout the duration of the exposure Press the Patient Entrance 6 key The unit will move into the...

Страница 94: ...ment and the control of all set parameters Since the X ray button is a dead man s switch it must be kept pressed until the end of the exposure 3 Once the exposure is completed the secondary collimator...

Страница 95: ...cessary to stop pressing the X ray button immediately to interrupt the emission of rays The following message will be displayed E 2 0 6 P R E S S 0 Then press the Patient Entrance 6 key The system now...

Страница 96: ...ng the hand wrist complex to obtain an X ray that contains the anatomic details necessary to evaluate the patient s bone growth trend The image format set in order to carry out this examination is 18x...

Страница 97: ...to remove the chin support while the second message tells him to close the temple clasps These operations are necessary to prevent interference with the rays beam and with the panoramic sensor holder...

Страница 98: ...e sensor in CEPH position following instruction in paragraph 6 2 and wait some seconds before to press Patient Entrance 6 key NOTE In case of a double sensor unit once the alignment is completed the f...

Страница 99: ...6 key to confirm or the Test 5 key to cancel the setting NOTE With the same image format the scanning time is lower in Normal Resolution this allows you to give the patient a smaller dose yet still ob...

Страница 100: ...atient slightly to the side of the cephalometry device 4 Position the patient s hand on the positioning support Figure 16 The support leads the operator to place the body part in the centre of the irr...

Страница 101: ...D Ready for X ray will light up indicating that the machine is ready to produce X rays NOTE If you want to cancel the operation press key Patient Entrance 6 2 Press the X ray button for the entire dur...

Страница 102: ...NOTE If you want to carry out a new exposure but the necessary waiting time for the cooling of the anode hasn t yet passed the display will show a message indicating the time you still have to wait be...

Страница 103: ...d by the operator or by pressing key Patient Entrance 6 The message displayed will be as follows E X X X P R E S S 0 xxx error message code number Operations are reset by pressing key 6 2 Messages gen...

Страница 104: ...al Assistance Service 6 10 2 Error message with error code E200 E299 This category of errors apply to the rotation motor of these only the error E206 Collision with patient caused by a possible collis...

Страница 105: ...ors These errors are related to the primary collimator Switch off the system and on again in case of further error message call the Technical Assistance Service 6 10 3 3 E340 Sensor holder not in PAN...

Страница 106: ...nction i e it must be kept pressed for the whole time of the examination also during the phases of the examination with emission interruption for instance in open close mouth TMJ This message signals...

Страница 107: ...6 10 5 1 E755 Safety Buckup Timer intervention This message is signalling that the RX emission has not ended at the correct time but it has been terminated by the Safety Backup Timer This hardware dev...

Страница 108: ...P O W E R O F F xxxxxxxx error message code number Release the key and switch ON again the unit If the problem is still present call Technical Service 6 10 6 2 E851 Column key pressed This error is di...

Страница 109: ...ee paragraph 6 5 3 points 3 4 6 7 and if necessary correct the height of the chin support Asymmetric dental arch The sagittal medial line does not correspond to the laser centring beam Realign the pat...

Страница 110: ...examination varying the kV and or the mA Increase them if the image was too clear and reduce them if it was too dark If the error is repeated call the Technical Service Image completely white No X ra...

Страница 111: ...hite this can mean that there is a defect in the alignment between X ray beams and sensor PAN or CEPH or a partial or total missing of irradiation in any case call the Technical Service 2 In the event...

Страница 112: ...bital complex In a good Panoramic you can distinguish the main anatomic structures that are simplified in the diagram below which indicates only the main ones and is not complete Figure 17 Ref Anatomi...

Страница 113: ...ive apron worn by the patient 2 Metal objects necklaces earrings etc must be avoided these objects not only create radio opaque images in their own position but also false images projected in other pa...

Страница 114: ...f the maxilla The result of all the above listed actions will be a radiography where all the parts are properly exposed and are well identifiable as in the diagram of Figure 19 Figure 19 It must be no...

Страница 115: ...oo many shadows disturbing the reading The resulting image is similar to the schema shown on Figure 20 Figure 20 Possible causes The patient it positioned too much forward Solution Check the patient s...

Страница 116: ...v 0 I Max Touch 110 120V 111 Anterior teeth are enlarged and blurred Figure 21 shows the result of this error Figure 21 Possible causes The patient it positioned too much backward Solution Check the p...

Страница 117: ...e the centre of the sagittal medial plane corresponds with the centre of the chin support but the patient s head is rotated In both cases one side is closer to the sensor plane than the other thus res...

Страница 118: ...em but if the defect is always present check the laser beam Solution Verify that the laser beam is vertical this check can be performed very quickly by using the laser beam and verifying that it falls...

Страница 119: ...are exposed outward with lines divergent upward In some cases the condylar vertices might not appear on the image Figure 24 Possible causes A Frankfurt plane tilted too much upward produces different...

Страница 120: ...the result of this type of error The temporo mandibular joints are shown very high up with lines converging towards the top In some cases the upper condyle might not be visible in the image Figure 25...

Страница 121: ...ct image of the lower incisors but the projection of the palate falls on the upper teeth apex as shown in Figure 26 Figure 26 In this case a light tilting forward and downward of the Frankfurt plane c...

Страница 122: ...figure shows these cases please consider that all structures have a bilateral duplicate Figure 28 Soft tissue Description Artefacts Description 2 Ear soft tissue 1 Space between tongue and palate All...

Страница 123: ...orption Shadows or bright artefacts The most common cause for the presence of these artefacts is the presence of metal objects worn by the patient earrings necklaces etc The necklaces worn by the pati...

Страница 124: ...position the leaded apron tight around the patient s shoulders and neck then carry out a new examination The teeth rows are overexposed As already described if the tongue is not positioned against the...

Страница 125: ...modified 2 Modify the KV mA and or time for Cephalometric programs parameters to suit your needs the Anatomic Manual mode indicator changes to manual New parameters can only be saved in Manual mode 3...

Страница 126: ...V mA 66 6 kV mA Medium 72 6 kV mA 64 6 kV mA Large 74 6 kV mA 68 6 kV mA Large 76 6 kV mA 66 6 kV mA SINUS Adult Child Small 66 6 kV mA 62 6 kV mA Medium 70 6 kV mA 64 6 kV mA Large 72 6 kV mA 66 6 kV...

Страница 127: ...or by a qualified technician The operator can control the following items check that the labels are complete and well fixed check possible oil leaks from the tube head check that the X ray button cab...

Страница 128: ...BOOK Installation Date Technician Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Ca...

Страница 129: ...USER S MANUAL Maintenance I Max Touch 110 120V Rev 0 124 THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 130: ...Code 6906910703_Rev0 0459 OWANDY 6 all e Kepler 77420 Champs sur Marne FRANCE Tel 33 01 64 11 18 18 Fax 33 01 64 11 18 10 www owandy com...

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