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User Manual - Specification of the intended use

NIMXEN020I

Owandy Radiology SAS

The air kerma for the other PANORAMIC exams available on the equipment can be calculated
using the ratios vs PANORAMIC EXAM in the table below:

Exam

Ratio

Half-panoramic

0.55

Low Dose

0.85

Ortho Rad panoramic

0.90

Frontal dentition

0.33

Bitewing L or R

0.24

Bitewing L and R

0.47

TMJ

0.71

Sinus

0.65

Содержание i-max touch 3D

Страница 1: ...EN USER MANUAL I MAX 3D NIMXEN020I June 2022...

Страница 2: ......

Страница 3: ...from 107 to 109 FDA approved revision Updated Warnings paragraph added pediatric use information Updated Cybersecurity measures paragraph Updated Quality assurance program chapter Added Metal artefac...

Страница 4: ...high definition for 3D Single Jaw 3D Maxillary Teeth and 3D Mandibular Teeth exams 0H 11 04 22 9 20 21 24 27 28 Update laser labels Update system labels Update exposure times Update laser and sensor...

Страница 5: ...User Manual Revision history NIMXEN020I Owandy Radiology SAS THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 6: ......

Страница 7: ...RY 11 3 2 1 1 INTRODUCTION 11 3 2 1 2 REFERENCES FOR PEDIATRIC DOSE OPTIMIZATION 11 3 2 1 3 DEVICE SPECIFIC FEATURES AND INSTRUCTIONS 11 3 3 INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY 12 3 3 1 EL...

Страница 8: ...E QUALITY CHECK 45 8 4 1 LOG BOOK 48 8 5 3D IMAGE QUALITY CHECK 49 8 5 1 QC TOOL SOFTWARE 49 8 5 2 3D TEST IMAGE ACQUISITION 51 8 5 3 NYQUIST FREQUENCY 53 8 5 4 CONTRAST TO NOISE RATIO 53 8 5 5 SPATIA...

Страница 9: ...12 9 TMJ SINGLE PHASE 83 12 10 SINUS 83 13 3D EXAMS 84 13 1 3D FULL DENTITION 84 13 2 3D SINUS 84 13 3 3D TMJ 84 13 4 3D SINGLE JAW 84 13 5 3D MAXILLARY TEETH 85 13 6 3D MANDIBULAR TEETH 85 13 7 3D E...

Страница 10: ...or their specifications to improve performances quality or reproducibility Product and its accessories specifications may change without advice No part of this publication can be reproduced transmitt...

Страница 11: ...ry Teeth Mandibular Teeth Extended Volume 3D Sinus 3D TMJ and 3D Airways The aim of this Manual is to instruct the user on the safe and effective use of the device The device must be used complying wi...

Страница 12: ...MAX 3D system can be used with the following type of patient Age paediatric from about 7 years to geriatric Patient status self sufficient patient the patient can autonomously place himself as reques...

Страница 13: ...by the X ray field area measured on the imaging sensor that is 52 cm far away from focal spot The typical size of the X ray beam on the imaging sensor depends on the selected exam for 2D exams 140 mm...

Страница 14: ...12 38 4 7 14 7 71 8 28 8 86 9 43 10 00 10 58 11 15 11 72 12 30 12 87 13 21 13 50 13 76 4 5 8 03 8 67 9 32 9 96 10 61 11 25 11 90 12 54 13 19 13 83 14 48 14 86 15 19 15 48 5 8 92 9 64 10 35 11 07 11 7...

Страница 15: ...erma for the other PANORAMIC exams available on the equipment can be calculated using the ratios vs PANORAMIC EXAM in the table below Exam Ratio Half panoramic 0 55 Low Dose 0 85 Ortho Rad panoramic 0...

Страница 16: ...3 18 3 40 3 62 3 84 4 06 4 29 4 51 4 73 4 95 5 17 5 39 5 61 4 5 3 08 3 33 3 58 3 83 4 07 4 32 4 57 4 82 5 07 5 32 5 57 5 82 6 06 6 31 5 3 42 3 70 3 98 4 25 4 53 4 80 5 08 5 36 5 63 5 91 6 19 6 46 6 74...

Страница 17: ...the operator or the patient caused both by installation and maintenance procedures other than those described in this Manual and in the Service Manual supplied with the unit and by erroneous operation...

Страница 18: ...nd corrosion Before cleaning the device make sure the main power supply has been disconnected from the equipment When pushing the ON OFF button of the equipment it must not come on Wherever necessary...

Страница 19: ...is affixed to I Max 3D to indicate a laser in class 1 is mounted internally and caution is advised Warning Always keep the room well lit Do not look into the output windows of laser centring units Do...

Страница 20: ...mself during radiography Warning Protection against radiation is regulated according to law The equipment may only be used by specialised personnel It is advisable to control the X ray emission from a...

Страница 21: ...iaea org resources rpop resources training material 11 5 HTTPS WWW IAEA ORG RESOURCES RPOP RESOURCES TRAINING MATERIAL 3 3 2 1 3 Device specific features and instructions I MAX 3D provides as standard...

Страница 22: ...t for which CISPR 11 class B is normally required this equipment even if it is usually permanently installed in X Ray shield locations might not offer adequate protection to radio frequency communicat...

Страница 23: ...Electromagnetic environment RF emissions CISPR 11 Group I I MAX 3D uses RF energy only for its internal function Therefore its R F emissions are very low and are not likely to cause any interference...

Страница 24: ...er quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 1 kV differential mode 0 5 1 2 kV common mode IEC 60601 1 2 Test level Mains power quality should be t...

Страница 25: ...nd should be periodically changed if the system is supplied with a PC the Windows user is password protected but it is user responsibility to change the default password and set new ones for all the d...

Страница 26: ...ment The symbol of the crossed waste container on the equipment or packaging shows that the product at the end of its lifecycle must be collected separately from other types of waste The separate coll...

Страница 27: ...liquids that at the end of the unit s lifecycle must be disposed of at appropriate disposal centres A C voltage N Connection point to the neutral conductor L Connection point to the line conductor Pr...

Страница 28: ...or use 0051 Conformity to the Directive 93 42 EEC and its revised version and all other applicable Directives Exposure enabled status the corresponding green LED is on X Ray emission the corresponding...

Страница 29: ...tion cables and then wipe with a dry cloth Do not use corrosive or abrasive detergents alcohol benzene trichloroethylene products containing quaternary ammonium The centring bite or the bite protectiv...

Страница 30: ...User Manual Description NIMXEN020I Owandy Radiology SAS 20 5 DESCRIPTION 5 1 Identification labels and laser labels 5 1 1 Position of Identification labels...

Страница 31: ...User Manual Description NIMXEN020I Owandy Radiology SAS 21 5 1 2 Warning and caution labels Laser symbol label Laser WARNING label WARNING label...

Страница 32: ...th automatic selection with manual selection it is possible to select a high voltage between 60kV and 86kV in 2kV steps and anodic current from 2 mA to 12 5 mA in the R20 scale steps 3D Mandibular Tee...

Страница 33: ...0Hz 6A 230V 50 60Hz Technical factors for maximum line current 86kV 12 5mA Power consumption 1 5kVA 115V 50 60Hz 1 3kVA 230V 50 60Hz Protection fuse F1 20 A T 250V 6 3x32 mm 10kA 125V 8 A T 250V 6 3x3...

Страница 34: ...f these exams are optional and depend on the system configuration Standard panoramic Half panoramic L R Ortho Rad panoramic Low dose panoramic Frontal dentition Bitewing Left Right Bitewing Left and R...

Страница 35: ...hape based on statistical studies establishes a form for the dentomaxillofacial complex adopted as standard I MAX 3D follows a rototranslation path which maintains the magnification factor as stated i...

Страница 36: ...rence loading conditions related to maximum energy input to the anode 2812 5mAs h 86 kV Nominal power 1 075 kW 86 kV 12 5 mA Total filtration 2 5 mm Al eq 86 kV HVL Half value layer 3 2 mm Al eq 86 kV...

Страница 37: ...or a detailed explanation LN60 650 Wave length 650 nm Divergence 2 0 mRad Optical power on the working surface 1 mW Laser class Class 1 laser product according to IEC standard 60825 1 2014 LN60 635 Wa...

Страница 38: ...l mount model this value refers to the recommended installation height 219 cm 86 Weight 67 kg base version Column base optional 6 kg Working conditions Minimum room size please refer to the Service Ma...

Страница 39: ...User Manual Technical characteristics NIMXEN020I Owandy Radiology SAS 29 6 1 Dimensions Figure 3 I MAX 3D dimensions Wall mounted version...

Страница 40: ...echnical characteristics NIMXEN020I Owandy Radiology SAS 30 Figure 4 I MAX 3D dimensions Wall mounted with floor support version 1524 2184 60 0 86 0 975 1635 38 4 64 4 797 31 4 1107 43 6 953 37 5 400...

Страница 41: ...ual Technical characteristics NIMXEN020I Owandy Radiology SAS 31 Figure 5 I MAX 3D dimensions Floor mounted version 1565 2225 61 6 87 6 991 1651 39 0 65 0 962 37 9 1272 50 0 953 37 5 790 31 1 996 39 2...

Страница 42: ...nual Technical characteristics NIMXEN020I Owandy Radiology SAS 32 1 2 Tube loading curves anode heating and cooling curves Tube CEI OPX 105 12 0 5 IEC 336 Tube loading curves Anode heating and cooling...

Страница 43: ...User Manual Technical characteristics NIMXEN020I Owandy Radiology SAS 33 Tube head cooling curve 0 50 100 150 200 250 300 350 400 0 100 200 300 400 500 600 min E kJ...

Страница 44: ...x 768 pixels Colour depth 16M of colours Contrast 500 1 Brightness 200 cd m2 In the following paragraphs are listed the minimum and suggested PC characteristics 6 2 1 PC minimum characteristics Mother...

Страница 45: ...be viewed with any software that can import view and manage 3D volumes saved in DICOM slices with the following maximum dimensions Normal resolution full volume 532 slices 492x492 pixels per slice 12...

Страница 46: ...1 3 2008 2nd Ed Medical electrical equipment Part 1 3 General Requirements for Radiation Protection in Diagnostic X Ray Equipment IEC 60601 1 3 2008 2nd Ed Am1 2013 ed 2 1 Medical electrical equipment...

Страница 47: ...1 1 2005 R 2012 and A1 2012 US National differences to IEC 60601 1 CFR 21 Code Federal Regulation Sub Chapter J 0051 Guarantees the compliance of I MAX 3D with Directives 93 42 EEC as amended 2011 65...

Страница 48: ...filtration 2 5 mm Al eq 86 kV Nominal Tomographic section thickness 0 175 mm 0 0875 mm in HR Image receptor are 144 x 118 6 mm 6 6 1 Reference Plane The reference plane offset is the horizontal plane...

Страница 49: ...measured as CTDI100 as recommended in the FDA Guidance doc Provision for Alternate Measure of the Computed Tomography Dose Index CDTI to Assure Compliance with the Dose Information Requirements of the...

Страница 50: ...s CDTIwi CDTIW 11 1 mGy 6 7 3 Measured Dose values for other conditions of operation The following table lists the relative CTDI values for different conditions of operations normalized to the value o...

Страница 51: ...NIMXEN020I Owandy Radiology SAS 41 6 7 4 Dose profile In the following graph the dose profile is displayed along a line z perpendicular to the tomographic plane measured in the center to the Dose Phan...

Страница 52: ...d Chin Support Standard chin support for panoramic examination mode Panoramic Chin Support Low It s a panoramic chin support lower in height which can be used in standard panoramic exams to ensure a b...

Страница 53: ...sed to check laser alignment and to hold the centering tool Centering tool used to check Panoramic image quality 3D quality phantom compliant with DIN 6868 161 used to check 3D image quality QuickVisi...

Страница 54: ...ON the unit and perform the axis reset by pressing the O button At the end of the axis positioning select standard Panoramic exam see paragraph 12 1 and press O Place the support plate Figure 10 on th...

Страница 55: ...ng operations It is recommended to use the greatest caution and to comply with local safety regulations and laws 1 Switch ON the unit see paragraph 9 1 2 Open QuickVision software and open the patient...

Страница 56: ...6 5 Mount the centering tool on the support plate and place it on the chin rest support Centering tool Support plate Figure 10 Support plate and centering tool positioning 6 On the main menu of the vi...

Страница 57: ...2D exam 8 Make an exposure at 66 kV 6 3 mA see chapter 10 9 Select the Ruler icon and measure the distance between the two external spheres this value must be 173mm 2mm In case the test fails call te...

Страница 58: ...User Manual Quality assurance program NIMXEN020I Owandy Radiology SAS 48 8 4 1 Log book Dimension Symmetry Acceptance range 171 175 mm 2 mm Date Measured value Measured value...

Страница 59: ...ftware The QC Tool software can be started either from the desktop shortcut or directly from QuickVision by right clicking on the acquired 3D test image as described below After each test record the m...

Страница 60: ...d skip to the next measure At the end of the test click on Save test in order to save the result The result of past test can be accessed from the main page of the QC tool by clicking on Past tests A t...

Страница 61: ...ded for the quality test create if not present a patient Quality Test and perform the following steps 1 From the virtual keyboard click on the Setting icon and verify that the apply anti artefact filt...

Страница 62: ...he chin rest and place the 3D quality phantom on the plate in such a way as the reference central line is on the top 3D Quality phantom Support plate Figure 13 5 On the PVC insertion is present a posi...

Страница 63: ...ample picture on the right panel 5 Figure 11 Verify that the Nyquist frequency value displayed is greater or equal to 1 Report this value in the Nyquist frequency cell of the QC log book at paragraph...

Страница 64: ...right panel 5 Figure 11 The mean and standard deviation of the gray levels inside the area are displayed The mean value must be in the range from 100 to 100 HU Report this value in the CT number cell...

Страница 65: ...ents are required The dose measures must be taken in free air with the dosimeter as close as possible to the image receptor plane and the exposure parameters set to Full Dentition 3D Adult patient Med...

Страница 66: ...ge noise Low contrast resolution High contrast resolution CT number Width measure Length measure Slice thickness Homogeneity Dose at isocentre Dose max aberration Acceptance Index Pass Criterion 1 CNR...

Страница 67: ...he PhD_Test software located at C Program Files x86 OWANDY OSP PHD PANORAMIC and check that the unit is connected to the PC the message MCU is connected is displayed in the bottom left corner of the p...

Страница 68: ...cceptance limits 60 2 3 55 2 to 64 8 kV 2 85 to 3 15 s 86 12 5 3 79 1 to 92 8 kV 2 85 to 3 15 s 7 In case the test fails result do not match the indicated values proceed with the following actions Che...

Страница 69: ...e program NIMXEN020I Owandy Radiology SAS 59 8 6 1 Log book Parameter set 60 kV 2mA 3s 86 kV 12 5 mA 3s Acceptance range 55 2 64 8 kV 2 85 3 15 s 79 1 92 8 kV 2 85 3 15 s Date kV measured Time measure...

Страница 70: ...t an exam see also chapter 10 1 Press O button on the keyboard to run the equipment axis zero 2 Run the GUI on the PC and wait for the connection between the PC and the equipment this status is indica...

Страница 71: ...tatus is signalled by the green LED on the equipment 3 Figure 17 and on the GUI lighting up Ready for X ray status remains as long as the equipment is in the start exam position and the GUI is connect...

Страница 72: ...ure a tight grip on the bite or are not co operating and might move during the exam The tiniest chin rest can be used with bite or with appendix for edentulous on 3D Maxillary Teeth and 3D Single Jaw...

Страница 73: ...IMXEN020I Owandy Radiology SAS 63 Thin chin support 3D Single Jaw Maxillary 3D Maxillary Teeth Frontal Premolar Molar Thin chin support with edentulous patients appendix 2D Sinus 3D Sinus 3D TMJ TMJ p...

Страница 74: ...General instructions for use NIMXEN020I Owandy Radiology SAS 64 Temple clamps must be always used to block the patient s head For 3D exams the head strip shall also be used Temple clamps Head strip f...

Страница 75: ...ing Column movement is not possible if the emergency button is pressed 3 The Luminous centring device key turn the laser centring devices ON OFF allowing the correct positioning of the patient 4 Light...

Страница 76: ...available Blue blinking fast the equipment is in error state Refer to the GUI for error description 7 The Centring Patient Entrance key is used to Start Stop the exam procedures Put the rotation arm...

Страница 77: ...trajectory are automatically updated based on the current selection Patient size selection Small Medium Large The pre set exposure values will be automatically updated based on the current selection...

Страница 78: ...rameters are manually changed the mode indicator switches from Anatomic to Manual Return to Anatomic mode using the main programme selection key Exam type selection is done in two steps for 2D exams F...

Страница 79: ...Interface is divided in three sections section 1 permit exam selection section 2 patient characteristic selection section 3 exposure parameters Selecting the area indicated in the red circle it is po...

Страница 80: ...election Scanning of dental impression and dental models only in 3D Mandibular single jaw and if High Definition mode is supported by PC see paragraph 6 2 A status bar indicates the current status of...

Страница 81: ...ED lighting up on the keyboard and on the Virtual Interface 4 Select the exam and parameters on the Virtual Interface 5 Press the button O on the keyboard to run the chin rest automatic positioning ac...

Страница 82: ...d deactivate the Test function by pressing the key again 12 Once the exposure is completed the system will rotate back to patient exit position It is now possible to free the patient from the position...

Страница 83: ...es and the temple clamps group thoroughly and change the disposable bite protective sleeve 10 1Anatomic Manual exposure Note If the previous exam was carried out manually press the Size Selection key...

Страница 84: ...Type of Biting Selection option available in Panoramic mode only Default exposure values in 2D Panoramic modes Adult Patient 14 seconds Child Patient 12 8 seconds kV mA kV mA Small 76 9 66 8 Medium 80...

Страница 85: ...ium 84 10 66 8 Large 84 12 5 68 8 Exposure values in 3D TMJ mode Adult Patient 6 2 seconds Child Patient 6 2 seconds kV mA kV mA Small 82 5 64 6 3 Medium 82 6 66 6 3 Large 82 7 68 6 3 Exposure values...

Страница 86: ...parameters can be set in manual mode To modify the kV or mA values press any of the up or down cursors of the KV or mA parameters A parameter can be modified by pressing the increase key and the decr...

Страница 87: ...OCESSING WINDOW The Image Processing menu if activated will be displayed at the end of the acquisition in order to customize the default image post processing settings The feature can be either enable...

Страница 88: ...s Clicking the button the corresponding filter will be applied and the preview displayed The default post processing can be modified through dedicated toolbars from the top respectively brightness con...

Страница 89: ...patient s anatomy can differ significantly from the statistical model so the magnification factor is not maintained and can be different from the value stated Based on his experience and competence t...

Страница 90: ...tions have the effect of compensating for greater X ray absorption in the spinal column area As an example the variation of the parameters follows the curve below Set value Actual value mA Actual valu...

Страница 91: ...n that the patient has a problem on only one half of the arch so it is possible to reduce patient irradiation Follow the instructions for normal panoramic exams for patient positioning 12 3Frontal den...

Страница 92: ...adiated the emission will start from the beginning to just after the mid sagittal plane for the right part For the left it will start just before the mid sagittal plane and continue until the end of t...

Страница 93: ...T condyle with closed mouth 1st exposure R RIGHT condyle with open mouth 3rd exposure LEFT condyle with open mouth 4th exposure LEFT condyle with closed mouth 2nd exposure L Figure 22 TMJ Open Closed...

Страница 94: ...61200 is present the acquired volume will change to 80x80 mm FOV 13 33D TMJ The acquired volume is an 85x90 mm FOV centered to the temporo mandibular joint right or left accordingly with the user sele...

Страница 95: ...mandibular arch depending on the user selection Two acquisition modes are available Standard definition 175 m voxel size for a standard resolution 3D acquisition and High definition 87 5 m voxel size...

Страница 96: ...tion mode is available see paragraph 6 2 the following dental impression dental model scan programs are available 1 Cast scan Denture 2 Dental impression Silicone 3 Plaster model To perform the scan p...

Страница 97: ...ive a specific filter for compensating metal artefacts will be applied during the exam reconstruction Figure 24 The same filter may be also applied removed retroactively at any time through the option...

Страница 98: ...y SAS 88 13 10 New reconstruction To run a new reconstruction of a 3D study select its icon inside the exam list of the patient folder and right click on it Then select New Reconstruction Figure 26 Th...

Страница 99: ...ton to run a new reconstruction with MAR correction A 3D study reconstructed with MAR filter active is identified the exam list of the patient folder with the MAR label as shown in figure Figure 28 No...

Страница 100: ...earrings glasses hairpins removable dental prosthesis etc Ensure there are no thick garments in the area to be X rayed coats jackets ties etc 2 Ask the patient to put on the protective apron or somet...

Страница 101: ...ithin the pre aligned anatomical references This ensures a greater extension of the spine in the cervical area improving the darkening of the X ray in the apical area of the incisors and avoiding the...

Страница 102: ...e clamps closing release knob 1 Panoramic chin rest 4 Laser Knob Figure 30 2D Panoramic 3D Full Dentition patient positioning Label Description Label Description 45 Sagittal medial line 3 Temple clamp...

Страница 103: ...Temple clamps closing release knob 46 Frankfurt line 4 Laser knob 1 TMJ positioner Figure 32 2D TMJ closed mouth patient positioning Label Description Label Description 45 Sagittal medial line 3 Templ...

Страница 104: ...ust be horizontal Spine should be well stretched In case of use of the bite patient s incisors must be positioned into the reference notch Patient s tongue must be against the palate Patient must stay...

Страница 105: ...al sensor of rotation axis always activated 201 Zero position optical sensor never activated 202 203 Zero position optical sensor of rotation still active after exiting from zero sensor 204 Unexpected...

Страница 106: ...760 Alarm NO RX button command 761 Alarm NO X ray emission 762 Bad unit status emission flag detected unexpectedly 763 kV analog feedback out of range 764 mA analog feedback out of range 765 Filament...

Страница 107: ...1202 Unexpected value detected by the software 1203 Software allocation failure 1204 Exposure parameters failure 1205 Image buffer allocation failure PC driver interface OSP VSP Code Error descriptio...

Страница 108: ...ow signs of breaking or wear Visual inspection Daily Check that the unit is not damaged externally in such a way that the safety of protection from radiation is compromised Visual inspection Daily Che...

Страница 109: ...d panoramic exam 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 34 Ref Anatomic structure 1 Pal...

Страница 110: ...X ray beam and the protective 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 i...

Страница 111: ...s are well represented and an equal magnification and sharpness of all structures can be seen The image must be symmetric with the ascending rami of the temporo mandibular joints almost parallel and s...

Страница 112: ...17 2 Patient positioning errors 17 2 1 Turned head Figure 37 Problem The patient s head is turned to one side left or right in the mid sagittal plane Effects Condyles are different in size The ramous...

Страница 113: ...ssessment NIMXEN020I Owandy Radiology SAS 103 17 2 2 Tilted head Figure 38 Problem The patient s head is tilted to one side Effects One condyle appears higher than the other one and the inferior borde...

Страница 114: ...is tilted downward Effects The roots of the mandibular anterior teeth are positioned outside the focal trough so it is out of focus and blurred The shadow of the hyoid bone is typically superimposed o...

Страница 115: ...plane is tilted backward Effects The roots of the maxillary anterior teeth are positioned outside the focal trough so it is out of focus and blurred The hard palate is superimposed over the apices of...

Страница 116: ...Tongue effect Figure 41 Problem The patient s tongue was not held closely to the roof of the mouth during the exposure Effects A dark air space between the dorsum of the tongue and the hard and soft p...

Страница 117: ...ssessment NIMXEN020I Owandy Radiology SAS 107 17 2 6 Spine effect Figure 42 Problem The patient is slumped Effects The spinal column isn t well stretched causing a ghost image of the spine superimpose...

Страница 118: ...Installation Date Technician Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause...

Страница 119: ...User Manual NIMXEN020G Owandy Radiology SAS 109...

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