Page 1 I-Max Touch 0051 User's Manual Version January, 2014 (Rev. 6c)
Page 2 USER'S MANUAL I-Max Touch - Rev 6 The manufacturer OWANDY RADIOLOGY reserves the right to make modifications to its products or to their specifications in order to improve the performance, quality, or ease of production. Specifications of products or accessories may be modified without prior notice.
Page 3: Table Of Contents
USER'S MANUAL I-Max Touch - Rev 6 Contents INTRODUCTION 1.1 Icons appearing in the manual ............... 8 SAFETY INFORMATION 2.1 Warnings ..................... 10 2.1.1 Electromagnetic emissions 13 2.1.2 Electromagnetic immunity 14 2.1.3 Recommended separation distances for non-life supporting equipment 15 ...
Page 4 USER'S MANUAL I-Max Touch - Rev 6 GENERAL INSTRUCTIONS FOR USE 6.1 Control panel - description and functions ..........38 6.1.1 Key function description 43 6.1.2 Acquired image display description 45 6.1.3 Pen Drive function description 46 6.2 Digital Sensor ..................47 ...
Page 5 USER'S MANUAL I-Max Touch - Rev 6 6.9 Cephalometric examination ..............108 6.9.1 Preparation of the device 109 6.9.2 Anatomic / Manual Exposure 112 6.9.2.1 Anatomic exposure .............. 113 6.9.2.2 Manual exposure ..............114 6.9.3 Preparation of the patient 115 ...
Page 6 USER'S MANUAL I-Max Touch - Rev 6 THIS PAGE IS INTENTIONALLY LEFT BLANK...
Page 7: Introduction
Please read this manual thoroughly before starting to use the unit; it is advisable to keep the manual near the device, for reference while operating. The I-Max Touch is an electro-medical device and it can be used only under the supervision of a physician or of highly qualified personnel, with the necessary knowledge on X-ray protection.
Page 8: Icons Appearing In The Manual
USER'S MANUAL I-Max Touch - Rev 6 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...
Page 9: Safety Information
Owandy Radiology cannot be held responsible for:  the use of the I-Max Touch 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...
Page 10: Warnings
The I-Max Touch must be switched off while using devices such as electrical lancets or similar apparatus. Please clean and disinfect, when necessary, all parts that can be in contact with the patient.
Page 11 USER'S MANUAL I-Max Touch - Rev 6 Minimum distance from X-ray source 2m Protected area Figure 1 - Panoramic version Minimum distance from X-ray source 2m Protected area Figure 2 - Cephalometric version...
Page 12 USER'S MANUAL I-Max Touch - Rev 6 WARNING: PRECAUTIONS WHILE USING LASER CENTERING DEVICES:  Always keep the room well lit.  Do not look into the output windows of laser centering units.  Do not stare at the reflections of laser pointers.
Page 13: Electromagnetic Emissions
2.1.1 Electromagnetic emissions In accordance with the IEC 60601-1-2 standard, the I-Max Touch is suitable for use in the specified electromagnetic environment. The purchaser or user of the system should assure that it is used in an electromagnetic environment as described below.
Page 14: Electromagnetic Immunity
2.1.2 Electromagnetic immunity In accordance with the IEC 60601-1-2 standard, the I-Max Touch is suitable for use in the specified electromagnetic environment. The purchaser or user of the system should assure that it is used in an electromagnetic environment as described below.
Page 15 USER'S MANUAL I-Max Touch - Rev 6 2.1.3 Recommended separation distances for non-life supporting equipment Typical Rated Distance R.F. source Power (W) Microcellular phone CT1, CT2, CT3 0.01 DECT cellular phone, wireless information 0.25 technology equipment (modems, LANs) Cellular phone, hand held (USA) Cellular phone, hand held (e.g.
Page 16: Environmental Risks And Disposal
USER'S MANUAL I-Max Touch - Rev 6 Environmental risks and disposal In some 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 centers.
Page 17: Symbols Used
USER'S MANUAL I-Max Touch - Rev 6 Symbols used In this manual and on the I-Max Touch itself, apart from the symbols indicated on the control panel, the following icons are also used (see Chapter Symbol Description Device with type B applied parts...
Page 18: Cleaning And Disinfection
USER'S MANUAL I-Max Touch - Rev 6 CLEANING AND DISINFECTION In order to guarantee a good level of hygiene and cleaning, it is necessary to respect the following procedures. WARNING: Disconnect the unit from the mains before performing any cleaning.
Page 19: Description
USER'S MANUAL I-Max Touch - Rev 6 DESCRIPTION Identification labels and laser labels 6, 7...
Page 20: Identification Labels And Laser Labels 110-120V
USER'S MANUAL I-Max Touch - Rev 6 Identification labels and laser labels 110-120V 1 I-Max Touch 2 Tube-head identification label identification label 3 CEPHALOMETRIC device identification label 4 PANO 5 PANCEPH Digital Sensor Digital Sensor identification label identification label 6 (N° 2) Spot Laser...
Page 21: Identification Labels And Laser Labels 220-240V
USER'S MANUAL I-Max Touch - Rev 6 Identification labels and laser labels 220-240V 1 I-Max Touch 2 Tube-head identification label identification label 3 CEPHALOMETRIC device identification label 4 PANO 5 PANCEPH Digital Sensor Digital Sensor identification label identification label 6 (N° 2) Spot Laser 7 (N°...
Page 22: Functions, Models And Versions
USER'S MANUAL I-Max Touch - Rev 6 Functions, models and versions The I-Max Touch, produced by OWANDY RADIOLOGY, is a complete panoramic system, which enables to perform all X-rays commonly necessary in dental field (except for endoral x-rays). In some versions, certain examination modes are not available but the device (thanks to its computerized control system) can be expanded and updated with new releases, directly at the Dentist premises.
Page 23: Version With Cephalometric Device
USER'S MANUAL I-Max Touch - Rev 6 4.4.2 Version with cephalometric device The version with cephalometric device allows you to perform the following examinations:  Panoramic, Emi-panoramic, Reduced dose Panoramic, Frontal dentition, Improved orthogonality Panoramic, Sinus, TMJ and Implant with the same characteristics described for the base version.
Page 24: Technical Characteristics
USER'S MANUAL I-Max Touch - Rev 6 TECHNICAL CHARACTERISTICS General features Type I-Max Touch Manufacturer OWANDY RADIOLOGY Croissy-Beaubourg, France Class Class II B for European Directive for Medical Devices 93/42 Class II for Canadian MDR Class I with type B applied parts...
Page 25: Exposure Times
USER'S MANUAL I-Max Touch - Rev 6 Exposure times Panoramic (PAN) 13.8 s PAN Adult / Child EmiPanoramic 7.4 s Adult / 7.3 s Child Improved orthogonality Panoramic 11.9 s Adult / Child Reduced dose Panoramic 11.4 s Adult / Child Frontal Dentition 4.4 s Adult / Child...
Page 26: Image Magnification
USER'S MANUAL I-Max Touch - Rev 6 Image magnification Adult / Child standard Panoramic 1 : 1.23 (constant over dentition part) TMJ open/closed mouth, 4 images 1 : 1.20 (nominal) Sinus 1 : 1.22 (nominal) Implant 1 : 1.32 (constant) Ceph 1 : 1.10 (on the sagittal medial plane in LL...
Page 27: Digital Sensor
USER'S MANUAL I-Max Touch - Rev 6 X-ray tube characteristics Manufacturer CEI Bologna (Italy) Type OPX 105 Nominal focus size 0.5 EN 60336 Inherent filtration 0.5mm Al eq. Anode tilt 5° Anode material Tungsten Nominal maximum voltage 105 kV Filament max current...
Page 28: Mechanical Characteristics
USER'S MANUAL I-Max Touch - Rev 6 Mechanical characteristics Focus-receptor distance (PAN, TMJ and 50 cm (20") Sinus) Focus-receptor distance (CEPH) 165 cm (65") Telescopic motorized column run 85 cm (33.5") Maximum total height 245 cm (96.5") Weight  161 kg base version ...
Page 29: Dimensions
USER'S MANUAL I-Max Touch - Rev 6 Dimensions 1020 (40,16") Ø 1040 (40,95") Ø 1140 (44,88") with free standing base Figure 3 – I-Max Touch dimensions Base version...
Page 30 USER'S MANUAL I-Max Touch - Rev 6 1020 (40,16") Ø 1040 (40,95") Ø 1140 (44,88") with free standing base 1910 (75,20") 1970 (77,56") with free standing base Figure 4 – I-Max Touch dimensions Version equipped with cephalometric unit...
Page 31: Loading Curve Of The Tube And Cooling Curve Of The Anode
USER'S MANUAL I-Max Touch - Rev 6 Loading curve of the tube and cooling curve of the anode Tube "CEI - OPX/105" (0.5 IEC 336) Load Anode cooling curve...
Page 32 USER'S MANUAL I-Max Touch - Rev 6 Tube-head heating and cooling curve...
Page 33: Applied Safety Regulations
Community. 5.3.1 Classifications The I-Max Touch is an electro-medical X-ray device belonging to Class I type B as per classifications EN 60601-1, provided for a continuous working at intermittent load. According to EC 93/42 Directives for medical devices, the equipment belongs to class II B.
Page 34: Note On Constant Magnification For Panoramic And Tmj (Mouth Open/Closed) Examinations
Note on constant magnification for Panoramic and TMJ (mouth open/closed) examinations NOTE:  The I-Max Touch is based on a standard dentition and ascending rami shape. This shape, based on statistical studies, establishes a form for the dentomaxillofacial complex, adopted as "standard".
Page 35: Measurement Method Of Technical Factors (Paragraph For Authorized Personnel)
USER'S MANUAL I-Max Touch - Rev 6 Measurement method of technical factors (paragraph for authorized personnel) WARNING: These measurements require the removal of the HF group covers; this means to gain access to internal parts where high voltage are normally present.
Page 36: Verification Method Of Technical Factors (Paragraph For Authorized Personnel)
USER'S MANUAL I-Max Touch - Rev 6 Verification method of technical factors (paragraph for authorized personnel) The exposure parameters (kV, time and dose) can be checked using the so- called "non-invasive method". WARNING: The device collimator gives a narrow X-ray beam.
Page 37 USER'S MANUAL I-Max Touch - Rev 6 3. The KV and mA parameters can be modified by pressing the increase key and the decrease key of the KV and mA on the display. The parameters can vary within the limits shown in the following table:...
Page 38 GENERAL INSTRUCTIONS FOR USE Control panel - description and functions The I-Max Touch keyboard is divided into function areas, plus a display to view the operative messages and error signals. The next figure shows a general view of the control interface, while details on each functional area are provided in the following pages.
Page 39 USER'S MANUAL I-Max Touch - Rev 6 The next figure shows a general view of the display of the acquired image, details on each functional area are provided in the following pages. Figure 6 Legend: Zoom out button USB port for pendrive...
Page 40 USER'S MANUAL I-Max Touch - Rev 6 The "Centering/Patient Entrance" button is used to: start/stop the start examination procedures bring the rotation arm to the patient entrance position at the end of the exam. The "Examination Selection Mode" takes place by means of three keys: the...
Page 41 ON/OFF the laser centering devices that allow the correct positioning of the medial-sagittal and Frankfurt planes, by adapting the I-Max Touch to the patient's anatomy. The key "Test" is used to avoid the Test OFF X-rays emission, in order to check the absence of collisions with the patient.
Page 42 USER'S MANUAL I-Max Touch - Rev 6 This key displays the acquired image stored in the memory of the unit; the main menu area is replaced by the View image image. Return Main Menu This key is used to return to the control panel (main menu) when an acquired image is displayed.
Page 43 USER'S MANUAL I-Max Touch - Rev 6 6.1.1 Key function description 11+12 Display Figure 7 - Control panel LEGEND: Messages Anatomic selection Display: indicates operative messages, warnings and Patient selection key: Adult or Child exposure parameters. Size selection key: Small, Normal, or Large...
Page 44 USER'S MANUAL I-Max Touch - Rev 6 Display USB port Image Figure 8 – Acquired image display LEGEND: Messages Acquired image display Display: indicates operative messages, warnings and Image: displays the last acquired image, stored in the exposure parameters. memory of the unit...
Page 45 USER'S MANUAL I-Max Touch - Rev 6 6.1.2 Acquired image display description Once an image has been acquired it is transferred to the computer through the network (if connected) and/or written on the USB pen drive (if inserted); the image remains in the memory of the unit until the unit is switched off or until a new image is acquired that replaces the previous one.
Page 46 USER'S MANUAL I-Max Touch - Rev 6 6.1.3 Pen Drive function description A pen drive can be inserted in the USB port at the top of the control panel. The pen drive has to be formatted in FAT or FAT32 (not in NTFS; please refer to your Windows manual and help for more information on formatting).
Page 47 USER'S MANUAL I-Max Touch - Rev 6 Digital Sensor The I-Max Touch is equipped with two types of digital sensors, depending on the version:  Sensor PAN: it is a sensor suitable for Panoramic-type imaging, i.e. all images with a 14cm-high field; all Panoramic, TMJ, and Sinus images belong to this type.
Page 48 USER'S MANUAL I-Max Touch - Rev 6 6.2.1 Inserting the sensor in the sensor holder The digital sensor is equipped with a handgrip used to safely transport the sensor from one holder to the other, in order to minimize the risk of fall. The...
Page 49 USER'S MANUAL I-Max Touch - Rev 6 6.2.2 Release of the sensor from the sensor holder The operations for releasing the sensor from the relative sensor holder are specular to the ones described for the hooking of the same. 1. Grip the sensor by the appropriate handgrip; close the fingers to form a...
Page 50 >TEST< NOTE:  During this phase, the I-Max Touch does not perform any movement, it just performs a series 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 holder;...
Page 51 USER'S MANUAL I-Max Touch - Rev 6 After 3 seconds, the following configuration will be automatically set by the system: ADULT with the display of the corresponding graphic in the button  MEDIUM SIZE with the display of the corresponding graphic in the button ...
Page 52 I-Max Touch - Rev 6 Positioning of chin support The I-Max Touch is equipped with different types of supports: a standard support fitted with a special removable appendix for edentulous patients, a lower one for SINUS examinations and a third one, to be used for TMJ examinations.
Page 53 USER'S MANUAL I-Max Touch - Rev 6 Panoramic examination When making a panoramic examination, the tube-head support arm (X-rays generator) makes a continuously rotating movement. After an initial acceleration, rotation is made at a constant speed. At the same time the arm carries out a scanning towards the support column.
Page 54 USER'S MANUAL I-Max Touch - Rev 6 6.5.1 Preparation of the device When the unit is switched on, the Panoramic Examination is selected as standard. If the operator has previously made another kind of examination to select Panoramic use the key "Examination Mode Selection" (10).
Page 55 USER'S MANUAL I-Max Touch - Rev 6 Right / Left Emi-panoramic  The Emi-panoramic mode, right or left, means that only the corresponding half arch is irradiated; 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 the rotation.
Page 56 Follow the instructions for normal Panoramic for patient positioning. NOTE:  The I-Max Touch is based on a standard dentition and ascending rami shape. This shape, based on statistic study, establishes a form for the dentomaxillofacial complex that it is assumed as "standard". The I-Max...
Page 57 USER'S MANUAL I-Max Touch - Rev 6 6.5.2 Anatomic / manual exposure NOTE:  If the previous exam was carried out manually, just press the key "Size Selection" (8) or the key "Selection Examination Mode" (10). After setting the machine, it is possible to choose between the following two...
Page 58 USER'S MANUAL I-Max Touch - Rev 6 6.5.2.1 Anatomic exposure Select the type of patient with the Adult/Child key (7). Select the type of build with the Size (8) key (small - medium - large). On the basis of these selections, the display will visualize the kV and mA settings as in the table.
Page 59 USER'S MANUAL I-Max Touch - Rev 6 6.5.2.2 Manual exposure If the kV and mA combinations of the Table 2 are not considered suitable for a specific examination, it will be possible to set new parameters using the manual mode.
Page 60 USER'S MANUAL I-Max Touch - Rev 6 6.5.3 Preparation of the patient 1. Ask the patient to remove all metallic objects located in the area to be X- rayed (necklaces, earrings, glasses, hairpins, removable dental prosthesis, etc.). Ensure that there are no thick garments in the area to be X-rayed (coats, jackets, ties, etc.).
Page 61 USER'S MANUAL I-Max Touch - Rev 6 Legend of Reference Lines 45 Sagittal medial line 46 Frankfurt plane line Legend positioning devices and patient centring Panoramic chin rest Centring bite Forehead support closing/release knob Temple clasps closing/release knob Figure 10: Panoramic positioning 7.
Page 62 USER'S MANUAL I-Max Touch - Rev 6 9. Press the key "Patient Entrance" (6) to confirm the parameters. The luminous centring devices switch off and the rotating arm goes to its examination start position. Once alignment has been completed, the following message will be displayed: xxkV xxmA 13.8s...
Page 63 USER'S MANUAL I-Max Touch - Rev 6 6.5.4 Making an exposure NOTE:  When the key "Test" (5) is pressed the Test function is activated. In this condition, it will be possible to make the unit perform all the movements made during the examination without emitting X-rays.
Page 64 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the situation.
Page 65 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  If you try to perform a new exam before the cooling period has elapsed (4 minutes), the following message will be displayed indicating the time to wait before performing a new examination:...
Page 66 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  During the Panoramic, the value of the exposure parameters varies according to a fixed curve, to compensate the variations in absorption by the patient's tissues. In this way, it is possible to obtain a good uniformity of the image contrast.
Page 67 USER'S MANUAL I-Max Touch - Rev 6 TMJ examination The TMJ examination with open/closed mouth is similar to panoramic; the only difference is that the exposure is performed only on the involved area (the temporo mandibular joint), then it stops, and starts again on the second joint.
Page 68 (see paragraph 6.4). NOTE:  The I-Max Touch is based on a standard dentition and ascending rami shape. This shape, based on statistical data, establishes a standard shape for the dentomaxillofacial complex, defining also the position and the direction of the condyles.
Page 69 USER'S MANUAL I-Max Touch - Rev 6 6.6.2 Anatomic / Manual Exposure NOTE:  If the previous exam was carried out manually, just press the key "Size Selection" (8) or the key "Examination Mode Selection" (10). After setting the machine, it is possible to choose between the following two...
Page 70 USER'S MANUAL I-Max Touch - Rev 6 6.6.2.1 Anatomic exposure Select the type of patient 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 visualize the kV and mA settings as in the table.
Page 71 USER'S MANUAL I-Max Touch - Rev 6 6.6.2.2 Manual exposure If the kV and mA combinations of the Table 3 are not considered suitable for a specific examination, it will be possible to set new parameters using the manual mode.
Page 72 USER'S MANUAL I-Max Touch - Rev 6 6.6.3 TMJ closed mouth 6.6.3.1 Preparation of the patient 1. Ask the patient to remove all metallic objects located in the area to be X- rayed (necklaces, earrings, glasses, hairpins, removable dental prosthesis, etc.).
Page 73 USER'S MANUAL I-Max Touch - Rev 6 5. Instruct the patient to close his eyes. 6. Press the key "Centring devices ON" (14). Two laser beams will light up the sagittal medial plane line and the horizontal line for the Frankfurt plane reference (the plane that identifies a line that ideally links the ear hole - the auditory meatus - with the lower part of the orbital fossa).
Page 74 USER'S MANUAL I-Max Touch - Rev 6 6.6.3.2 Carrying out the first exposure (mouth closed) WARNING: During the emission of X-rays, the protection procedures for the operator and personnel in the area must be in compliance with the local regulations. In all cases, it is recommended that during the emission of X-rays, only the patient and operator be present in the room.
Page 75 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the situation.
Page 76 USER'S MANUAL I-Max Touch - Rev 6 6.6.4 TMJ open mouth 6.6.4.1 Preparation of the patient 1. The patient must be prepared following the operations described in paragraph 6.6.3.1. The following message will be displayed: INSTRUCT PATIENT TO OPEN MOUTH 2.
Page 77 USER'S MANUAL I-Max Touch - Rev 6 4. Instruct the patient to close his eyes. 5. Press the key "Centring devices ON" (14). Two laser beams will light up the sagittal medial plane line and the horizontal line for the Frankfurt plane reference.
Page 78 USER'S MANUAL I-Max Touch - Rev 6 6.6.4.2 Carrying out the second exposure (mouth open) WARNING: During the emission of X-rays, the protection procedures for the operator and personnel in the area must be in compliance with the local regulations. In all cases, it is recommended that during the emission of X-rays, only the patient and operator be present in the room.
Page 79 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The rotation of the arm and the emission of the X-rays will start with a delay of 2 seconds from when the X-ray button is pressed. As the X-ray button is a "dead man's switch", it is necessary to keep it pressed until the end of the exposure.
Page 80 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  If, during the exposure, the patient moves, or the machine collides with the patient himself (or with any object), or you realize that the parameters set are not correct, you must release the X-ray button immediately, interrupting the emission of X-rays and the movement of the arm.
Page 81 X-rays emission limited to the interested area. NOTE:  The I-Max Touch is based on a standard dentition and ascending rami shape. This shape, based on statistical data, establishes a standard shape for the dentomaxillofacial complex, defining also the position and the direction of the condyles.
Page 82 USER'S MANUAL I-Max Touch - Rev 6 6.7.1 Anatomic / Manual Exposure NOTE:  If the previous exam was carried out manually, just press the key "Size Selection" (8) or the key "Examination Mode Selection" (10). After setting the machine, it is possible to choose between the following two...
Page 83 USER'S MANUAL I-Max Touch - Rev 6 6.7.1.1 Anatomic exposure Select the type of patient 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 visualize the kV and mA settings as in the table.
Page 84 USER'S MANUAL I-Max Touch - Rev 6 6.7.1.2 Manual exposure If the kV and mA combinations of the Table 4 are not considered suitable for a specific examination, it will be possible to set new parameters using the manual mode.
Page 85 USER'S MANUAL I-Max Touch - Rev 6 6.7.2 Preparation of the patient 1. Ask the patient to remove all metallic objects located in the area to be X- rayed (necklaces, earrings, glasses, hairpins, removable dental prosthesis, etc.). Ensure that there are no thick garments in the area to be X-rayed (coats, jackets, ties, etc.).
Page 86 USER'S MANUAL I-Max Touch - Rev 6 5. Instruct the patient to close his eyes. 6. Press the key "Centering devices ON" (14). Two laser beams will light up the sagittal medial plane line and the horizontal line for the Frankfurt plane reference (the plane that identifies a line that ideally links the ear hole - the auditory meatus - with the lower part of the orbital fossa).
Page 87 USER'S MANUAL I-Max Touch - Rev 6 6.7.3 Making an exposure WARNING: During the emission of X-rays, the protection procedures for the operator and personnel in the area must be in compliance with the local regulations. In all cases, it is recommended that during the emission of X-rays, only the patient and operator be present in the room.
Page 88 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the situation.
Page 89 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  If you try to perform a new exam before the cooling period has elapsed (4 minutes), the following message will be displayed indicating the time to wait before performing a new examination:...
Page 90 I-Max Touch - Rev 6 IMPLANT examination The Implant package for I-Max Touch is a valuable tool for taking transversals cross sections of the dental arch for preliminary Implant evaluation and follow Essential requirements for a tomographic examination in the surgical planning phase are to correctly determine the available space for Implant;...
Page 91 USER'S MANUAL I-Max Touch - Rev 6 Figure 15 Please refer to paragraph 6.8.7 to have suggestions on how to view images and their correct interpretation (please refer to Figure 19 and following).
Page 92 (*) number to input into the unit Figure 16 The linear tomography implemented on I-Max Touch is based on a statistical model of dental arch, as defined in international literature. However, it must be considered that the natural deviation from the model due to the individual variability can lead to the possibility that the point of interest may be not perfectly centered on the middle of the images.
Page 93 6.8.2 Implant Bite Block set-up To perform the implant mode, I-Max Touch is delivered with two special "Implant bite blocks", used to hold the patient on the point of interest: the first bite block is used for the maxilla while the second one is used for mandible (for simplicity, they will be referred to as: maxilla implant bite block and mandible implant bite block).
Page 94 USER'S MANUAL I-Max Touch - Rev 6 6.8.2.1 Bite block preparing: Maxilla Implant 1. Insert the bite in the relevant Maxilla bite support; tighten the knob 1 to fix the bite at the maximum height. 2. Select the desired metal place face according to the Figures below.
Page 95 USER'S MANUAL I-Max Touch - Rev 6 6.8.2.2 Bite block preparing: Mandible Implant This examination has to be performed with the patient’s head inclined in order to keep the mandible border in the point of interest as horizontal as possible;...
Page 96 USER'S MANUAL I-Max Touch - Rev 6 6.8.3 Equipment preparation To select the IMPLANT examination, press key "Examination Mode Selection" (10) until the following message and graphic is displayed: xxkV xxmA 9.20s MANDIB IMPL R 44 The system is positioned in the following configuration: ADULT with the display of the corresponding graphic in the button ...
Page 97 START EXAM x = value defined by the settings NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the...
Page 98 USER'S MANUAL I-Max Touch - Rev 6 After this selection, remove the skull clamp assembly and the chin support; position the implant bite block chosen according to the maxilla or mandible examination. NOTE:  Before use, it is mandatory to perform a cold disinfecting of the plastic bite using, for instance, a 2% water solution of Glutaraldehydes according to the instruction for use specified by its manufacturer.
Page 99 USER'S MANUAL I-Max Touch - Rev 6 6.8.4 Manual / Anatomic exposure NOTE:  If the previous exam was carried out manually, just press the key "Size Selection" (8) or the key "Examination Mode Selection" (10). After setting the machine, it is possible to choose between the following two...
Page 100 USER'S MANUAL I-Max Touch - Rev 6 6.8.4.2 Manual exposure If the kV and mA combinations are not considered suitable for a specific examination, it will be possible to set new parameters using the manual mode. To modify the kV or mA values, press any of the up (3) or down (4) arrows of the KV or mA parameters, the blue frames around the "Adult/Child Selection"...
Page 101 How to prepare the patient The patient’s preparation is the key factor in order to have diagnostic images, because of the geometrical relations between I-Max Touch and the natural individual variability of patients. The following suggestions must be adapted with the experience and the user radiological skill.
Page 102 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The laser centring device can be switched off using "Centring Devices ON" (14) key. 7. Make the following recommendations to the patient: the mouth must remain closed, he/she must remain perfectly still and do not look at the...
Page 103 >X-RAY< x = value defined by the settings NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the...
Page 104 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The rotation of the arm and the emission of the X-rays will start with a delay of 2 seconds from when the X-ray button is pressed. In addition, during the examination the emission of the X-rays is interrupted and started again more than once, to produce the 3 projections.
Page 105 USER'S MANUAL I-Max Touch - Rev 6 WARNING: After every examination, clean the Implant bite support, the bite and the handles as described in chapter 3. NOTE:  If, during the exposure, the patient moves, or the machine collides with...
Page 106 USER'S MANUAL I-Max Touch - Rev 6 6.8.7 Radiographic results The result obtained at the end of the examination is indicated in Figure 19. Second First transversal transversal Third transversal image image image (point of interest) Figure 19: Implant complete exam...
Page 107 USER'S MANUAL I-Max Touch - Rev 6 6.8.7.1 Right side tomography (quadrants 1 and 4) The next three images show the transversal sections, with the vestibular part on the left and the lingual or palatal part on the right (Figure 20).
Page 108 The I-Max Touch makes different kinds of exposures, according to the type of selection made: 24x22...
Page 109 USER'S MANUAL I-Max Touch - Rev 6 6.9.1 Preparation of the device To select the CEPH examination, press key "Examination Mode Selection" (10) until the following message and graphic is displayed: xxkV xxmA 4.50s CE 18x22LLN 8.5 x = value defined by the settings 1.
Page 110 USER'S MANUAL I-Max Touch - Rev 6 2. Once what was required is performed, press the key "Patient Entrance" (6); messages will disappear and the machine will align automatically with respect to the digital sensor and the following message will be displayed: AXIS POSITIONING PLEASE WAIT…...
Page 111 USER'S MANUAL I-Max Touch - Rev 6 You can pass from Normal Resolution (indicated by the letter "n") to High Resolution (indicated by the letter "h"), by pressing key "Examination Mode Selection" (10) and vice versa. Pressing twice the key (10) the unit will return to PANORAMIC STD position;...
Page 112 USER'S MANUAL I-Max Touch - Rev 6 6.9.2 Anatomic / Manual Exposure NOTE:  If the previous exam was carried out manually, just press the key "Examination Mode Selection" (10) to change to Anatomic exposure. In this case, pressing selection key does not modify the choice of resolution, which is modified by pressing the same key again.
Page 113 USER'S MANUAL I-Max Touch - Rev 6 6.9.2.1 Anatomic exposure Select the type of patient with the Adult/Child key (7). Select the type of build with the Size (8) key (small - medium - large). The kV and mA values will be displayed according to the selections made as...
Page 114 USER'S MANUAL I-Max Touch - Rev 6 6.9.2.2 Manual exposure If the kV and mA combinations in the table Table 5 are not considered suitable for a specific examination, it will be possible to set new parameters using the manual mode.
Page 115 USER'S MANUAL I-Max Touch - Rev 6 6.9.3 Preparation of the patient 1. Ask the patient to remove all metallic objects located in the area to be X- rayed (necklaces, earrings, glasses, hairpins, removable dental prosthesis, etc.). Ensure that there are no thick garments in the area to be X-rayed (coats, jackets, ties, etc.).
Page 116 USER'S MANUAL I-Max Touch - Rev 6 6.9.4 Making an exposure WARNING: During the emission of X-rays, the protection procedures for the operator and personnel in the area must be in compliance with the regulations in force in the country where the machine is used. In all cases, it is recommended that during the emission of X-rays, only the patient and operator be present in the room.
Page 117 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the situation.
Page 118 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  If the patient moves during the exposure, or if you realize that incorrect parameters have been set, it will be necessary to stop pressing the X-ray button immediately, to interrupt the emission of rays. The following...
Page 119 USER'S MANUAL I-Max Touch - Rev 6 6.10 Examination to assess bone growth (Carpus) The cephalometric device can also be used to carry out X-rays to evaluate the state of calcification and bone growth, X-raying the hand/wrist complex to obtain an X-ray that contains the anatomic details necessary to evaluate the patient's bone growth trend.
Page 120 USER'S MANUAL I-Max Touch - Rev 6 6.10.1 Preparation of the device 1. Select the CEPH examination, pressing key "Examination Mode Selection" (10) until the following message and graphic is displayed: xxkV xxmA 4.50s CE 18x22LLn 8.5 x = value defined by the settings 2.
Page 121 USER'S MANUAL I-Max Touch - Rev 6 4. Once what was required is performed, press the key "Patient Entrance" (6); messages will disappear and the machine will align automatically with respect to the digital sensor and the following message will be displayed: AXIS POSITIONING PLEASE WAIT…...
Page 122 USER'S MANUAL I-Max Touch - Rev 6 Pressing twice the key (10) the unit will return to PANORAMIC STD position; the display shows: CONFIRM PAN? >O< = Y, T = N Press the "Patient Entrance" (6) key to confirm or the "Test" (5) key to cancel the setting.
Page 123 USER'S MANUAL I-Max Touch - Rev 6 6.10.2 Preparation of the patient 1. Turn the ear centring device to the Antero-Posterior position; bring the nose-rest to a parking position. 2. Hook up the positioning support for hand projection, by screwing it on the related housing close to the ear centering device.
Page 124 >X-RAY< x = value defined by the settings NOTE:  The I-Max Touch assumes that the digital sensor is ready: if this is not the case, the following error message will be displayed: DIGITAL SENSOR IS NOT READY Refer to the Manual of the Digital Acquisition System to correct the...
Page 125 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  X-rays are emitted with a delay of two seconds from pressing the X-ray button to allow the heating of the filament 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.
Page 126 I-Max Touch - Rev 6 6.11 Messages on display The I-Max Touch is fully controlled by a microprocessor which controls the programming of the emission parameters and signals the various conditions of the machine, the possible abnormalities and errors via displayed messages.
Page 127 USER'S MANUAL I-Max Touch - Rev 6 6.11.1 Error message with error code E000  E199 NOT resettable errors. These are internal errors of the control system; it is necessary to call the Technical Assistance Service. 6.11.1.1 E110 – Battery fault This message means that the clock battery is low or fault.
Page 128 USER'S MANUAL I-Max Touch - Rev 6 6.11.3 Error message with error code E300  E399 6.11.3.1 Error message with code error E300  E303 NOT resettable errors. These errors are related to the secondary collimator of the Digital CEPH.
Page 129 USER'S MANUAL I-Max Touch - Rev 6 6.11.3.5 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).
Page 130 USER'S MANUAL I-Max Touch - Rev 6 6.11.4 Error message with error code E400  E402 NOT resettable errors. These errors are related to the Soft Tissue Filter of the Digital CEPH. Switch off the system and on again, in case of further error message, call the Technical Assistance Service.
Page 131 USER'S MANUAL I-Max Touch - Rev 6 6.11.6 Error message with error code E850  E852 These errors signal abnormal situations due to the operator's interface. 6.11.6.1 E850 - One or more keys appear to be pressed on start-up The system checks that all keys are not pressed at start-up; if one or more appear to be pressed, this error is displayed.
Page 132 USER'S MANUAL I-Max Touch - Rev 6 6.12 Research and correction of possible defects in dental X-rays 6.12.1 Faults due to the wrong positioning of the patient Problem Description Solution Overlarge and blurred The patient is not positioned Position the patient correctly, check incisors.
Page 133 USER'S MANUAL I-Max Touch - Rev 6 6.12.2 Defects due to wrong data setting Problem Description Solution Light or poorly The set kV values are not Try to modify the contrast, using the contrasted image. adequate for the size of the appropriate commands of the image Over-dark image.
Page 134 USER'S MANUAL I-Max Touch - Rev 6 6.12.3 Defects due to the device 1. Should the image show non irradiated areas or be completely white, 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;...
Page 135 USER'S MANUAL I-Max Touch - Rev 6 6.13 Analysis of the problems on the panoramic examinations The panoramic radiography is the examination of the maxillo-facial region normally used to view the dental region inside the complete head and sinuses- orbital complex.
Page 136 USER'S MANUAL I-Max Touch - Rev 6 6.13.1 Proper positioning of the patient The proper positioning of the patient during the panoramic examination is very important in order to get a good quality radiography. This is due to the fact that the shape of the focussed area, e.g. of the layer clearly shown on the image, tends to follow the dental arch and has a non-constant deepness.
Page 137 USER'S MANUAL I-Max Touch - Rev 6 6. The patient’s tongue must be positioned against his palate. Otherwise, the air between the tongue and the palate forms an area of lower absorption, which leads to a darker area that hides the apex of the teeth of the maxilla.
Page 138 USER'S MANUAL I-Max Touch - Rev 6 6.13.1.1 Errors due to poor positioning of patient The image shows the anterior teeth with reduced magnification  and not well defined. The cervical spine is shown as evident white shadow. In addition, on the molar zone there are too many shadows, disturbing the reading.
Page 139 USER'S MANUAL I-Max Touch - Rev 6 Anterior teeth are enlarged and blurred  Figure 28 shows the result of this error. Figure 28 Possible causes: The patient it positioned too much backward. Solution: Check the patient's positioning by using luminous beams.
Page 140 USER'S MANUAL I-Max Touch - Rev 6 Part of the image is enlarged while the other is reduced  The schema described on Figure 29 the image obtained; it is possible to observe that one part of the radiography is blurred and enlarged, while the other is reduced and seems to be in focus;...
Page 141 USER'S MANUAL I-Max Touch - Rev 6 The image shows the upper vertex of the condylar rami of  different heights; Figure 30 shows the result of this error. Figure 30 Possible causes: The sagittal medial plane is not vertical. This can be the patient’s problem, but if the defect is always present, check the laser...
Page 142 USER'S MANUAL I-Max Touch - Rev 6 The image shows undulated teeth rows  As can be seen in Figure 31, the upper teeth are magnified and unfocused, with the shadow of the hard palate positioned over the superior apex. The temporo-mandibular joints are exposed outward, with lines divergent upward.
Page 143 USER'S MANUAL I-Max Touch - Rev 6 The radiographic image shows the teeth row too curved upward  with the lower incisor not focused Figure 32 shows 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.
Page 144 USER'S MANUAL I-Max Touch - Rev 6 NOTE:  In some cases, the positioning of the Frankfurt plane too tilted downward produces a correct image of the lower incisors, but the projection of the palate falls on the upper teeth apex, as shown in Figure 33.
Page 145 USER'S MANUAL I-Max Touch - Rev 6 6.13.1.2 Images with artefacts Radiographs that show images with soft tissues or artefacts  The radiographs may show anatomical parts of the soft tissues or show radiographic artefacts. Normally the soft tissues might be more or less...
Page 146 USER'S MANUAL I-Max Touch - Rev 6 This is not true, because it is derived from the projection geometry used to obtain the panoramic image. The effect can be more evident if the image in underexposed due to wrong radiological parameters.
Page 147 USER'S MANUAL I-Max Touch - Rev 6 Non-exposed area in the lower-central part of the image  If the problem appears as shown in point "5" of Figure 35 above, it indicates that there has been interference between the leaded apron worn by the patient and the X-ray beam.
Page 148 USER'S MANUAL I-Max Touch - Rev 6 6.14 Storing of automatic exposure parameters The pre-set technical exposure factors can be varied according to the needs of the user, or to obtain somewhat more contrasted images. To modify the automatic exposure parameters, please follow the indicated procedure: 1.
Page 149 USER'S MANUAL I-Max Touch - Rev 6 6.14.1 Table of pre-set anatomic parameters PANORAMIC TMJ open/close mouth Child Child Adult Adult Small Small Medium Medium Large Large SINUS Adult Child Small Medium Large CEPHALOMETRY (L.L.) CEPHALOMETRY (A/P - P/A) Child...
Page 150 USER'S MANUAL I-Max Touch - Rev 6 Maxilla IMPLANT Tooth Tooth Tooth Tooth Tooth Tooth Tooth Tooth 11/21 12/22 13/23 14/24 15/25 16/26 17/27 18/28 9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 Small 9.20 9.20 9.20 9.20 7.30 7.30 7.30...
Page 151 USER'S MANUAL I-Max Touch - Rev 6 MAINTENANCE This unit, like all other electrical appliances, must be used correctly and also serviced and controlled at regular intervals. This precaution ensures a safe and efficient performance. The periodical maintenance consists in checks performed by the operator himself and/or by a qualified technician.
Page 152 USER'S MANUAL I-Max Touch - Rev 6 MAINTENANCE LOGBOOK Installation: Date ... Technician ....Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....

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