Owandy I-Max Touch Operation & User’s Manual

i Contents 1. INTRODUCTION 1 1.1 Icons appearing in the manual ............................................................... 2 2. SAFETY INFORMATION 3 2.1 Warnings ................................................................................................ 4 2.2 Environmental risks and displacement................................................... 7 2.3 Symbols used ......................................................................................... 8 3. CLEANING AND DISINFECTION 9 4. DESCRIPTION 10 4.1 Identification labels and laser labels ..................................................... 10 4.2 Functions, models and versions............................................................ 12 4.2.1 Basic version............................................................................ 12 4.2.2 Version with cephalometric device............................................ 13 5. TECHNICAL CHARACTERISTICS 14 5.1 Dimensions........................................................................................... 19 5.2 Loading curve of the tube and cooling curve 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 for authorised personnel) ........................................................................... 25 5.6 Verification method of technical factors (paragraph for authorised personnel) ........................................................................... 26 6. GENERAL INSTRUCTIONS FOR USE 28 6.1 Control panel - description and functions............................................. 28 6.1.1 Key function description........................................................... 33 6.1.2 Acquired image display description .......................................... 35 6.1.3 Pen Drive function description.................................................. 36 6.2 Digital Sensor ....................................................................................... 37 6.2.1 Inserting the sensor in the sensor holder.................................. 38 6.2.2 Release of the sensor from the sensor holder............................ 39 6.3 Switching on the device ........................................................................ 40 6.4 Positioning of chin support ................................................................... 42

(Rev. 0) ii 6.5 Panoramic examination ........................................................................ 43 6.5.1 Preparation of the device .......................................................... 44 6.5.2 Anatomic / manual exposure ................................................... 47 6.5.2.1 Anatomic exposure .............................................................. 48 6.5.2.2 Manual exposure ................................................................. 49 6.5.3 Preparation of the patient ......................................................... 51 6.5.4 Making an exposure ................................................................. 53 6.6 TMJ examination .................................................................................. 57 6.6.1 Preparation of the device .......................................................... 58 6.6.2 Anatomic / Manual Exposure................................................... 59 6.6.2.1 Anatomic exposure .............................................................. 60 6.6.2.2 Manual exposure ................................................................. 61 6.6.3 TMJ closed mouth .................................................................... 62 6.6.3.1 Preparation of the patient..................................................... 62 6.6.3.2 Carrying out the first exposure (mouth closed)...................... 64 6.6.4 TMJ open mouth ...................................................................... 66 6.6.4.1 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 exposure ................................................................. 74 6.7.2 Preparation of the patient ......................................................... 75 6.7.3 Making an exposure ................................................................. 77 6.8 Cephalometric examination .................................................................. 80 6.8.1 Preparation of the device .......................................................... 81 6.8.2 Anatomic / Manual Exposure................................................... 84 6.8.2.1 Anatomic exposure .............................................................. 85 6.8.2.2 Manual exposure ................................................................. 86 6.8.3 Preparation of the patient ......................................................... 87 6.8.4 Making an exposure ................................................................. 88 6.9 Examination to assess bone growth (Carpus)........................................ 91 6.9.1 Preparation of the device .......................................................... 92 6.9.2 Preparation of the patient ......................................................... 95 6.9.3 Making an exposure ................................................................. 96 6.10 Messages on display ............................................................................. 98 6.10.1 Error message with error code E000 ÷ E199............................. 99 6.10.2 Error message with error code E200 ÷ E299............................. 99

iii 6.10.3 Error message with error code E300 ÷ E399........................... 100 6.10.3.1 Error message with code error E300 ÷ E303 ....................... 100 6.10.3.2 Error message with code error E320 ÷ E323 ....................... 100 6.10.3.3 E340 - Sensor holder not in PAN position ........................... 100 6.10.3.4 E360 / E361 - X-ray button pressed during start up or axis movement 100 6.10.3.5 E362 - X-ray button released during examination ............... 101 6.10.4 Error message with error code E400 ÷ E402........................... 102 6.10.5 Error message with error code E700 ÷ E799........................... 102 6.10.5.1 E755 – Safety Buckup Timer intervention........................... 102 6.10.5.2 E774 - X-rays button not pressed....................................... 102 6.10.5.3 E775 - X-rays button released prematurely......................... 102 6.10.6 Error message with error code 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 Research and correction of possible defects in dental X-rays .............. 104 6.11.1 Faults due to the wrong positioning of the patient.................. 104 6.11.2 Defects due to wrong data setting........................................... 105 6.11.3 Defects due to the device ........................................................ 106 6.12 Analysis of the problems on the panoramic examinations................... 107 6.12.1 Proper positioning of the patient............................................. 108 6.12.1.1 Errors due to poor positioning of patient............................. 110 6.12.1.2 Images with artefacts ......................................................... 117 6.13 Storing of automatical exposure parameters....................................... 120 6.13.1 Table of pre-set anatomic parameters..................................... 121 7. MAINTENANCE 122 No part of this publication can be reproduced, transmitted, transcribed or translated without the approval of Owandy. This manual in English is the original version.

1 1. INTRODUCTION NOTE: The present manual is updated for the product it is sold with, in order to guarantee an adequate reference to use the product properly and safely. The manual may not reflect changes to the product that do not affect operating modes or safety. The I-Max Touch, produced by Owandy, is an X-ray device for the radiographic analysis of the maxillo-facial complex. The basic version of the I-Max Touch performs Panoramic, Emi- panoramic, Reduced dose Panoramic, Frontal dentition, Improved orthogonality Panoramic, Sinus and TMJ examinations of the maxillo- facial complex. The following options are available, and must be ordered separately: • DIGITAL CEPH; it allows the execution of the following examinations, all available 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 the device. This Manual is limited to the description of the X-ray device; instructions on the Digital Acquisition System are given in the relevant Manuals, supplied with the Direct Digital Sensor. The device must be used complying with the procedures described and never be used for purposes different from those herewith indicated. 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. The user is liable as concerns legal fulfilment related to the installation and the operation of the device. *

(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 safety aspects of the patient and/or the operator. *

3 2. SAFETY INFORMATION WARNING: Please read this chapter thoroughly. Owandy designs and builds its devices in compliance with the safety requirements; furthermore it supplies all information necessary for correct use, and the warnings related to danger associated with X-ray generating units. Owandy 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 this Manual and in the Service Manual supplied with the unit, and by wrong operations • mechanical and/or electrical modifications performed during and after the installation, different from those described in the service manual. Installation and any technical intervention must only be performed by qualified technicians authorised by Owandy. Only authorised personnel can remove the covers and/or have access to the components under tension.

(Rev. 0) 4 2.1 Warnings This device has not been designed to be used in environments where vapours, anaesthetic mixtures flammable with air, or oxygen and nitrous oxide, can be detected. Do not let water, or other liquids, into the device, as this could cause short-circuits and corrosion. Before cleaning the device, be sure that the main power supply has been disconnected from the equipment. Pushing the ON/OFF button on the basement of the equipment, it mustn't switch on. Wherever necessary, use the appropriate accessories, such as the leaded aprons, to protect the patient from radiation. While performing the radiography, no-one, apart from the operator and the patient, must remain in the room. The I-Max Touch has been built to support a continuous operation at intermittent load; therefore please follow the described use cycles to enable the device to cool down. Although this unit has been designed with an acceptable level of protection from electromagnetic interference, in compliance with international 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 (UPS) units, from portable receiving-transmitting units for amateur use. The use of cellular telephones is only admitted at a distance of more than 1.5m (4.9 ft) from any component of the device. Other medical instruments and devices that must be used in the same installation area of the unit must comply with the Electromagnetic Compatibility rules in force. Non-complying instruments, of which the poor immunity to electromagnetic fields is well known, must be installed at least 3 m (9.8 ft) from the device, and supplied by a different electrical line. 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. Never try to rotate the moving arm manually when the unit is switched on, to avoid permanent damage to the unit. Movement is only possible in case of Error 206 because motors are disabled to permit the patient exit. After use, please replace the disposable bite protective sleeve and the ear-centring devices.

5 Although the dose supplied by dental X-ray units is quite low and distributed on a fairly small surface, the operator must adopt the precautions and/or suitable protection for the patient and himself, during the execution 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 allows, or at least 1.5m (4.9 ft) both from the X-ray source and from the patient, as shown in Figure 1 and Figure 2. Minimum distance from X-ray source 1.5m Protected area Figure 1 - Panoramic version Minimum distance from X-ray source 1.5m Protected area Figure 2 - Cephalometric version

(Rev. 0) 6 WARNING: PRECAUTIONS WHILE USING LASER CENTRING DEVICES: • Always keep the room well lit. • Do not look into the output windows of laser centring units. • Do not stare at the reflections of laser pointers. • Instruct the patient to keep his/her eyes closed as long as the laser pointers are active. • Before starting an examination, the patient must remove earrings, glasses, necklaces and whatever else could reflect the laser beam or be impressed on the radiographic image. • Do not clean the 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 ejection of dangerous non-ionising radiation. 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. NOTE: Patient environment is defined as a distance of at least 1.5 m (4.9 ft) from the patient. If the PC is positioned outside the patient environment when in use, the PC has to be compliant to IEC 60950, otherwise the PC must complies with medical standard IEC 60601-1. NOTE: When the unit is switched on, do not move the rotating arm or the tube-head. * *

7 2.2 Environmental risks and displacement 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 centres. In particular, the device contains the following materials and/or components: • Tube-head: dielectric oil, lead, copper, iron, aluminium, glass, tungsten. • Control Panel: iron, copper, aluminium, glass-resin, non- biodegradable plastic material packaging. • Column, rotating arm and extensions: iron, lead, aluminium, copper, glass-resin, and non-biodegradable plastic material.

(Rev. 0) 8 2.3 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 6): Symbol Description Device with type B applied parts 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 centres ∼∼∼∼ A.C. N Connection point to the neutral conductor L Connection point to the line conductor Protection earthing Operation earthing OFF; device not connected to the mains  ON; device connected to the mains Laser Laser source output Dangerous voltage Moving parts MUST NOT be cleaned or lubricated 0459 Conformity to the EC 93/42 Directive

(Rev. 0) I-Max Touch (110-120V) 9 3. 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. Do not let water or other liquids enter the unit, as these could cause corrosion or short-circuiting. Use only a wet cloth and a 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 disposable bite protective sleeve and the ear centring devices of the cephalostatus must be replaced after each examination in which they have been used. Thoroughly clean the chin support, resting handles, nose-rest and temple clasps group any time these are used. The chin support, resting handles, nose-rest and temple clasps group should be disinfected (when considered necessary) with a solution of 2% glutaraldehyde.

(Rev. 0) 10 4. DESCRIPTION 4.1 Identification labels and laser labels 4 3 6, 7 1, 8 2 5

11 1 I-Max Touch 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 Laser identification label 7 (N° 2) Laser symbol label 8 WARNING label

(Rev. 0) 12 4.2 Functions, models and versions The I-Max Touch, produced by Owandy, 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 computerised control system) can be expanded and updated with new releases, directly at the Dentist premises. The basic version performs Panoramic, Emi-panoramic, Reduced dose Panoramic, Frontal dentition, Improved orthogonality Panoramic Sinus and TMJ examinations. Optional functions enable the system to perform the following additional examinations: • CEPH Allows you to carry out the following examinations: − CEPH exam in different formats − CARPUS exam. 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; in manual selection it is possible to select high voltage between 60kV and 86kV, in 2kV steps and anodic current from 6 mA to 10 mA in 1 mA steps. • Sinus enables to perform images of the paranasal sinuses with front projection (postero/anterior). • TMJ mouth closed/open in lateral projection. • The right or left Emi-panoramic is used when the patient is known to have a problem only on one side of the arch, in order to reduce the radiation. • The reduced dose Panoramic reduces the dose radiated on the dentition by excluding the TMJ's ascending rami from the exams. • The frontal dentition enables to perform examinations of the front part (roughly from canine to canine). • The Panoramic with improved orthogonality reduces the overlap of the teeth, thereby improving the diagnosis of interproximal decay.

13 4.2.2 Version with cephalometric device The version with cephalometric device allows you to perform the following examinations: • Panoramic, Sinus, TMJ, Emi-panoramic, Reduced dose Panoramic, Frontal dentition and Improved orthogonality Panoramic, Adult and Child, with the same characteristics described for the base version. • Digital Cephalometry for Adult and Children with 3 Sizes each. Within each combination, it is possible to select an examination in Hight or Normal Resolution, for a total of 12 combinations in Automatic selection. In Normal Resolution, the examination is carried out with a lower scanning time, allowing a further reduction of the dose. In Manual selection it is possible to vary the Hight Voltage from 60kV to 86kV, with 2kV steps, the anodic current from 6mA to 12mA with 1mA steps. The positioning of the sliding primary collimator, the 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 possible emphasis of the face profile. • Examination to evaluate the bone growth (Carpus) only Child with 3 Sizes. It is possible to select an examination in High or Normal Resolution, for a total of 6 combinations in Automatic selection. In Normal Resolution, the examination is carried out with a lower scanning time, allowing a further reduction of the dose. In Manual selection it is possible to vary the tension from 60kV to 86kV, with 2kV steps, the anodic current from 6mA to 12mA with 1mA steps. The positioning of the sliding primary collimator, the secondary collimator and the Digital Sensor (inside the relative sensor holder) is automatic The values of the exposure factors shown in the tables of paragraph 6.13, set as default, are for guidance only. The real adjustment of these values depends on user’s trade off between expose dose and image contrast. Image processing should help you getting the best contrast.

(Rev. 0) 14 5. TECHNICAL CHARACTERISTICS General features Type I-Max Touch Manufacturer OWANDY Champs sur Marne, 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 according to IEC 60601-1 Class II according to 21CFR- subchapter J Protection degree IPX0 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 switching power supply 3 A T HF generator board protection fuses F1: 10 A F F2: 5 A HF F3: 2 A T Line voltage regulation < 3 % at 99 V∼ Rated output voltage (kVp) 60 ÷ 86 kVp, with 2 kVp steps Anodic current 6 ÷ 10 mA, with 1 mA steps for PAN, TMJ, and Sinus 6 ÷ 12 mA in 1 mA steps for Ceph (up to 76 kVp) 6 ÷ 10 mA in 1 mA steps for Ceph (from 78 kVp to 86 kVp) Sensor cover additional filtration 0.5 mm Al eq @ 70 kVp

15 Exposure times Panoramic (PAN) 13.8 s PAN Adult / 13.4 s PAN 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 TMJ mouth closed/open 2.44 s per image for left and right joint in open and closed condition, total of 9.7 s Sinus P/A projection 9.4 s Cephalometry (Ceph) Exposure time variable according to the type of resolution and format selected. 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 selection • Collimator with automatic positioning Panoramic • Standard Panoramic • Half Panoramic L/R • Improved orthogonality Panoramic • Reduced dose Panoramic • Frontal dentition TMJ (Temporal Mandibular Joint) TMJ open and closed mouth Sinus Sinus P/A projection Cephalometry and Carpus • Normal resolution cephalometry in Latero-Lateral or Antero-Posterior projection (different formats) • High resolution cephalometry Latero- Lateral or Antero-Posterior projection (different formats) • Normal and High Resolution Carpus exam • Motorized Soft Tissue Filter.

(Rev. 0) 16 Image magnification Standard Panoramic Constant over dentition part: 1 : 1.23 Adult - 1 : 1.25 Child TMJ open/closed mouth, 4 images 1 : 1.20 (nominal) Sinus 1 : 1.22 (nominal) Ceph 1 : 1.10 (on the sagittal medial plane in LL projection) Tube-head characteristics Model MRE 05 Manufacturer Villa Sistemi Medicali S.p.A. 20090 Buccinasco (MI) Italia Maximum tube voltage 86 kVp kVp accuracy ± 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 insulation Oil bath Cooling By convection Leakage radiation at 1 m < 0.5 mGy/h @ 86 kVp - 12 mA - 3 s duty cycle 1/16 Tube-head maximum thermic capacity 310 kJ X-ray tube characteristics Manufacturer CEI Bologna (Italy) Type OPX 105 Nominal focus size 0.5 IEC 60336 Inherent filtration 0.5 mm Al eq. Anode tilt 5° Anode material Tungsten Nominal maximum voltage 105 kVp Filament max current 4 A Filament max voltage 8 V Anode thermal capacity 30 kJ

17 Digital Sensor Sensible area (H x L) • PAN sensor: 146 x 6 mm • PANCEPH sensor: 220 x 6 mm Pixel dimensions 48 µm, 96 µm in binning 2x2 (PAN and PANCEPH HR), 144 µm CEPH nR Pixel (H) NOTE: Number of horizontal pixels depends on the exam and resolution on CEPH. • PAN: 1536 • CEPH: 1536 in nR, 2304 in HR Laser centring devices 2 laser beams are used for the patient positioning; beams align mid Sagittal and Frankfurt planes (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 in 30s application period 0.05m Mechanical characteristics Focus-receptor distance (PAN, TMJ and Sinus) 50 cm (19.7") Focus-receptor distance (CEPH) 165 cm (65") Telescopic motorised column run 85 cm (33.5") Maximum total height 245 cm (96.5") Weight • 161 kg (354 lbs) base version • 186 kg (409 lbs) version with Ceph Column weight 87 kg (192 lbs) Weight of arm support, rotating arm and tube head 74 kg (163 lbs) CEPH arm 25 kg (55 lbs) Legs (optional) 30 kg (66 lbs) Sensor holder weight 2 kg (5 lbs)

(Rev. 0) 18 Working conditions Minimum room size (please refer to the Service Manual) • 130x120 cm (51.2"x47.2") without CEPH • 145x202 cm (57"x78.7") 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 humidity (RH) range 30% ÷ 75% Temperature range for transport and storing - 20° ÷ + 70° Humidity range for transport and storing < 95% without condense Minimum atmospheric pressure for transport and storing 630 hPa

19 5.1 Dimensions 1260 (49,60") Ø 1040 (40,95") 905 (35,63") 1755 (69,10") ÷ ÷ 1600 (63,00") 2450 (96,46") 1009 (39,74") Ø 1140 (44,88") with free standing base Figure 3 – I-Max Touch dimensions Base version

(Rev. 0) 20 1260 (49,60") Ø 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") Ø 1140 (44,88") with free standing base 1970 (77,56") with free standing base Figure 4 – I-Max Touch dimensions Version equipped with cephalometric unit

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

(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]

23 5.3 Applied safety regulations The I-Max Touch complies with the following standards: 0459 The symbol CE grants that I-Max Touch complies with directives 93/42 for medical devices issued by the European Community. • Canadian Medical Device Regulations • 21 CFR Subchapter J • General safety: IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-4:1996 + 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 + A2:2001 Classification I-Max Touch is an electro-medical X-ray device belonging to Class 1 and Type B as per classification IEC 60601-1, foreseen for a continuous working at intermittent load. According to CE 93/42 directive for medical devices, the equipment belongs to class II B. According to Canadian MDR, the equipment belongs to class II. According to FDA 21 CFR, the equipment belongs to class II.

(Rev. 0) 24 5.4 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". The I-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 dentition area. The 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, the user has to judge this variation. IN ANY CASE, THE RADIOGRAPHY IMAGES CANNOT BE USED TO PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON THE IMAGE. *

25 5.5 Measurement method of technical factors (paragraph for authorised 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. For the measurement of the exposure parameters with the invasive method, please follow the procedure described in the Service manual. WARNING: During the panoramic examination, the set value of kV and tube current 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. In particular, the chosen value is lowered 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 corresponds to the one chosen by the user, while the real value can be different; this fact must be considered if the exposure parameters are checked using standard diagnostic mode. The accuracy of the exposure parameters kV and mA, stated in the Technical Data section, refers to the accuracy compared with the instantaneous value set by the system. In any case, the manufacturer guarantees that the accuracy of the exposure parameters is always in compliance with the international standards for the safety of medical devices IEC 60601-1. In particular, in accordance with IEC 60601-2-7, the maximum deviation (including the correction and instrumental doubt) is less than or equal to ±10 for kV, while for tube current it is less than or equal to ±15%.

(Rev. 0) 26 5.6 Verification method of technical factors (paragraph for authorised 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. Measurements taken with a non-invasive instrument and a narrow beam can be difficult and/or unreliable; it is therefore necessary to use a special probe with a reduced sensitive area. It may be helpful to use a fluorescent screen to locate the X-ray beam, and consequently position the probe of the 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 indicator until it turns green and displays "S" , then press the "Test function" (5) key to enter the exposure verification mode, the display shows: x x k V x x m A x x . x s E M I S S I O N P R O G R A M WARNING: The following operations involve the emission of X-rays, so the Authorised Technician must pay the greatest attention and respect the protection regulations in force in that country. NOTE: This program allows you to carry out the measuring of the exposure parameters with the tube-head arm in a fixed position (not rotating) without variation due to spine compensation. 2. Place the measuring instrument. *

27 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: Parameter Minimum value Maximum value kV 60 86 mA 6 12 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 to the fact that the non-invasive method may introduce errors for instruments tolerance or wrong measurement condition. 5. To end the control program, press any key other than the increase and decrease keys ; the display will indicate: x x k V x x m A x x . x s P A N O R A M I C - S T D and the unit will return to standard mode. *

I-Max Touch (110-120V) (Rev. 0) 28 6. GENERAL INSTRUCTIONS FOR USE 6.1 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. 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 in progress" "Centring/Patient Entrance" button "Exposure Parameters Variation" button Light signalling "Ready for X-rays" "Exam mode selection" buttons "Centring devices ON" button Messages display "Test" button "Adult/Child selection" button "Size Selection" button "Type of biting selection" button "Column movement" button "Automatic/Manual mode" indicator "USB Pen Drive" button "View acquired image" button

(Rev. 0) I-Max Touch (110-120V) 29 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 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. Acquired image "USB Pen Drive" button "Return to main menu" button "Zoom out" button "Zoom in" button USB port for pen drive

I-Max Touch (110-120V) (Rev. 0) 30 The "Centring/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 first one, the main button, helps select the exam mode between Panoramic, TMJ, Sinus, and Cephalometric. 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 kind of selection enables to choose between Adult/Child, each with three different sizes (small, medium, large). Child Adult Large Medium Small The Panoramic mode enables to select the patient's type of biting between: protruded, standard or retracted, as indicated within the button. The arch selection does not influence the values of kV and mA but acts on the position of the focus layer. Protruded Standard Retracted

(Rev. 0) I-Max Touch (110-120V) 31 Furthermore there is the possibility to manually select the exposure parameters; in this case, it is possible to set the parameter with the desired value. The parameters available are: kV and mA (Soft Tissue Filter position, mm, only in cephalometry). When the exposure parameters are changed manually, the mode indicator switches from "Anatomic" to "Manual". Return to "Anatomic mode" using the main programme selection button. By holding the indicator for more than 1 second the special mode is activated and the indicator changes colour. In special mode modified 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 user that by pressing the X-ray button key once more, X-rays emission will start; the second indicates the effective emission of X-rays. The movement of the column is controlled by the appropriate keys. The speed has two set values. The movements are enabled during equipment setting. The key "Luminous centring device" helps turn ON/OFF the laser centring devices that allow the correct positioning of the medial-sagittal and Frankfurt planes, by adapting the I-Max Touch to the patient's anatomy. Test OFF Test ON The key "Test" is used to avoid the X-rays emission, in order to check the absence of collisions with the patient.

I-Max Touch (110-120V) (Rev. 0) 32 This key displays the acquired image stored in the memory of the unit; the main menu area is replaced by the image. View image This key is used to return to the control panel (main menu) when an acquired image is displayed. Return Main Menu The Pen Drive key appears when a pen drive (memory stick) is inserted in the USB connector 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 space and is ready for use. When the key is orange, it is busy; the image is being written on the pen drive. When the key is red, the pen drive does not have enough free space on it, or it is not recognised. Full/error In operation Ready for use When the acquired image is displayed on the control panel screen, it is possible to zoom in and out of the image using these two keys. Zoom in Zoom out

(Rev. 0) I-Max Touch (110-120V) 33 6.1.1 Key function description Figure 7 - Control panel LEGEND: Messages Display: indicates operative messages, warnings and exposure parameters. Signal lights 1 - Light indicating the machine is ready for X-ray emission (green LED) 2 - Yellow LED indicating X-ray emission Manual setting of exposure parameters 3 - kV, mA and Soft Tissue Filter increase keys 4 - kV, mA and Soft Tissue Filter decrease keys Preparation functions 5 - Key to set Test function 6 - Key for: > Resetting and realigning the device's axes (in case of collision 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 > Confirmation Anatomic selection 7 - Patient selection key: Adult or Child 8 - Size selection key: Small, Normal, or Large 9 - Arch selection key: Protruded, Standard or Retracted (for panoramic execution) Examination mode 10 - Exam mode selection key 11 +12 - Type of exam selection keys (only for panoramic mode) 13 - Mode indicator: Anatomic or Manual Centring devices 14 - Sagittal and Frankfurt plane centring device ON/OFF key Column height adjustment 15 - Column up key 16 - Column down key Other 17 - Display acquired image key 18 - USB Pen Drive key 1 2 6 10 18 17 7 8 14 3 4 9 Display 11+12 13 5 16 15

I-Max Touch (110-120V) (Rev. 0) 34 Figure 8 – Acquired image display LEGEND: Messages Display: indicates 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 acquired image, stored in the memory of the unit 20 - Zoom out on the image 21 - Zoom in on the image 21 Image Display 20 18 19 USB port

(Rev. 0) I-Max Touch (110-120V) 35 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. During acquisition, image is progressively 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 displayed on the screen of the control panel. The image can be zoomed in and out on, using keys (20) and (21) . When the image is zoomed in on, it is possible to move around the image to display parts of the image that are not visible on the screen; this can be done using a stylus or using a finger. Key (19) returns to the control panel, allowing for the acquisition of a new image. In the control panel, key (17) returns to the display of the acquired image.

I-Max Touch (110-120V) (Rev. 0) 36 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). As soon as the pen drive has been inserted, the unit will verify it. • If the pen drive is formatted with the right file system and there is enough free space available to save at least one image, the pen drive key (18) on the screen will be displayed in green . • If the pen drive is not formatted with the right file system or if there is not enough free space available to save at least one image, 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 drive has been formatted with the FAT or FAT32 and not with the NTSF (or Linux or Mac) file system, if not please use another pen drive or reformat the pen drive with the correct file system. WARNING: Make sure, before reformatting a pen drive, to copy all the data it contains onto your harddisk or CD/DVD; once the pen drive is reformatted all data on it will be irreparably lost! • When an image is being written to the pen drive, the pen drive key (18) on the screen will be displayed in orange (busy state). Do not extract the Pen Drive from the keyboard when the Pen Drive key (18) is orange. • When the keyboard displays the acquired image, pressing the green Pen Drive key (18) will save the current acquired image on Pen Drive.

(Rev. 0) I-Max Touch (110-120V) 37 6.2 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 14 cm-high field; all Panoramic, TMJ, and Sinus images belong to this type. Depending on the version, this sensor can be either movable from the sensor holder, or fixed (not removable) on the same holder. In case the sensor is fixed to the sensor holder, the latter cannot be rotated to make free the part where rays go through for the execution of the cephalometric examination. • PAN/CEPH sensor: it offers a wider use flexibility, as it can carry out both Panoramic and Cephalometric-type images. This sensor can always be removed from its sensor holder's. The I-Max Touch can also be configured in the "double sensor" version, where both PAN and PAN/CEPH sensors are present. 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 case the image management and processing system is not ready to receive the image itself, by displaying the message "Sensor not ready" • To prevent the CEPH exposure in case the PAN sensor is in the CEPH position, by displaying the message "Sensor not on Ceph" • To prevent the exposure in case, when a double-sensor system is present, the PAN sensor holder is not completely open, allowing the clearing of the X-ray beam path. The message "Open cassette holder" is displayed. NOTE: All sensor types are equipped with a shock detection sensor; this sensor is also visible from the outside to enable to operator to perform checks. Possible shocks are displayed by a change in colour (from transparent/white to red) of this sensor. The digital sensor can still function correctly also when the colour changes, displaying a fall that might also not have damaged the sensor. NOTE: The fall sensor colour change interrupts the warranty on the sensor. * *

I-Max Touch (110-120V) (Rev. 0) 38 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 minimise the risk of fall. The system used to hook the mobile sensor to the holder is also engineered to reduce the sensor's risk of fall due to failure to hook the sensor and/or due to early release. Inside the transport handgrip there is a lever that controls the sensor's hooking and release operations; at the same time, this lever works on the electronic connector in order to guarantee the correctness of the connection operations. On the fixed part of the sensor holder, there are two hooks that need to be inserted into the corresponding gaps on the mobile part of the sensor. On this latter, metallic plugs have been mounted which, by joining in the corresponding fixed part, guide 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 appropriate handgrip; close your fingers to form a fist, by engaging the control lever and bring it to the position where the lever disappears inside the handgrip, so that the whole mobile system retracts. 2. Keep the sensor with the relative handgrips vertical, so that the upper plane is parallel to the horizontal part of the sensor holder, bring the sensor close to the fixed station, by engaging the protruding part of the mobile sensor into the relative casing. 3. Push the sensor mobile part to the very end, in order to engage the mobile part onto the fixed hooking system. 4. Carry out a movement towards the lower part, ensuring that the movement is complete. 5. Only at this point, release the hooking lever, checking that the sensor is correctly engaged before releasing the handgrip. WARNING: During the lever releasing operation, hold the sensor firmly, to prevent the sensor from falling during the insertion phase due to possible errors.

(Rev. 0) I-Max Touch (110-120V) 39 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 fist, by engaging the control lever and bring it to the position where the same disappears inside the handgrip, 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, in order to free the mobile part from the hooking system. 3. By keeping the sensor with the upper part parallel to the relative horizontal part, carry out a horizontal movement in order to free the protruding part of the sensor from the relative casing of the sensor holder, disengaging thus the hooking system. 4. Always gripping firmly the sensor, in order to avoid accidental falls, it is possible to freely move the sensor to the desired position.

I-Max Touch (110-120V) (Rev. 0) 40 6.3 Switching on the device Press the green button on the base of the column to switch the system on; the display shows: I M A X T O U C H H W = x . x x S W = x x . x x This message will be present for about 20 seconds. After this time the LEDs on the control panel start blinking and on the display will be present the following message: I M A X T O U C H R E L E A S E * . * * 3 seconds later, the display shows the following message: > T E S T < 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; in this case, the following message will be displayed: C L O S E C A S S E T T E P A N O R A M I C When the self-diagnosis is completed, the following appears on the display: M A C H I N E S E T T I N G P R E S S > 0 < Press key (6) to start the device alignment phase. Once the key has been pressed, the message disappears and the display shows the following message during the alignment of the axes: W A I T F O R . . . M A C H I N E S E T T I N G WARNING: During this phase, the machine checks for possible obstacles that may create collisions simulating the movements performed during the examination. *

(Rev. 0) I-Max Touch (110-120V) 41 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 • STANDARD DENTITION with the display of the corresponding graphic in the button and the display shows (for instance): x x k V x x m A 1 3 . 8 s P A N O R A M I C - S T D THE MACHINE IS READY NOTE: The above mentioned position is chosen also in the event that, for any reason, the device repeats the initialisation phase. *

I-Max Touch (110-120V) (Rev. 0) 42 6.4 Positioning of chin support The I-Max Touch is equipped with two types of supports: a standard support fitted with a special removable appendix for edentulous patients, and a lower one, for SINUS/TMJ examinations. The standard chin support must be used, in Panoramic mode, with 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-operating and might move during the examination. For the SINUS/TMJ examinations, there is special support that, being in a lower position, ensures a better centring of the interested area in the rays field. Panoramic standard chin support Edentulous patients appendix SINUS/TMJ chin support NOTE: Always remove the chin support when performing Ceph examinations. *

(Rev. 0) I-Max Touch (110-120V) 43 6.5 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. 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 beams, which indicate the position of the sagittal medial plane; the corresponding patient's plane needs to be aligned with this plane. The latter is held in place, during the examination phase, by means of temple clasps rods and of a forehead support. A fourth fixing point is determined by the chin support.

I-Max Touch (110-120V) (Rev. 0) 44 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) . By doing so, it is possible to modify the type of examination between STD PANORAMIC, TMJ O/C, SINUS, CEPH; such variation takes place with continuous rotation, therefore, to move from the TMJ O/C mode to the STD PANORAMIC the key needs to be pressed 3 times. After selection Panoramic, the system positions itself with the following configuration: • ADULT with the display of the corresponding graphic 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 and graphic showing the default exposure parameters (if this is the first panoramic exposure), or the exposure parameters (kV and mA) of the last exposure performed. For example: 7 2 k V 0 6 m A 1 3 . 8 s P A N O R A M I C - S T D Once the settings have been completed, the chin support must be placed in position. The key "Examination Mode Selection" (10) enables the selection of specific submodes, selectable by means of the keys "Arrow right" (12) and "Arrow left" (11), enabling the sliding in one direction or another. Previous examination Next examination For the Panoramic examination, the following selections are possible: STD Panoramic -> Right Emi-panoramic -> Left Emi-panoramic -> Reduced dose Panoramic -> Improved orthogonality dentition -> Frontal dentition -> STD Panoramic. This selection is cyclic, so pressing the button repeatedly will change the selected mode.

(Rev. 0) I-Max Touch (110-120V) 45 • 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. These two kinds of examinations are usually used when it is already known that the patient has a problem on only one half of the arch, so it is possible to reduce the irradiation of the patient. Follow the instructions for normal Panoramic for patient positioning. • Reduced dose Panoramic The reduced dose Panoramic examination makes an X-ray only of the dental arch, excluding from the image the ascending rami of the temporo-mandibular 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 phases or where the lack of pathologies of the same joint is already known. Follow the instructions for normal Panoramic for patient positioning. • Improved orthogonality dentition The improved orthogonality Panoramic delivers the image of the pure dental arch cutting out from the image the ascending rami branches of the temporo mandibular joint; the trajectory of the rotating arms is, however, optimised for a better orthogonality between the X-ray beam and the incident sections of near teeth. Thus the image has reduced overlapping of the teeth, improving the diagnosis of interproximal decay. As a consequence of the different trajectory, the focus layer, mainly in the front teeth area, is smaller and the patient positioning for this examination needs more care. Follow the instructions for normal Panoramic for patient positioning.

I-Max Touch (110-120V) (Rev. 0) 46 • Frontal dentition The Frontal dentition examination performs an X-ray of the dentition frontal area (roughly from canine to canine). 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 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 and in the dentition area. The 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, the user has to judge this variation. IN ANY CASE, THE RADIOGRAPHY IMAGES CANNOT BE USED TO PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. *

(Rev. 0) I-Max Touch (110-120V) 47 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 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 and mA values already set. NOTE: In manual condition, the "Anatomic/Manual mode" (13) indicator displays "M" to indicate the manual mode; it is possible to press key (7) to change from Adult to Child and press key (9) to modify the type of biting from Normal to Protruded to Retracted. * *

I-Max Touch (110-120V) (Rev. 0) 48 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 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 74 6 68 6 Table 2 Select the type of biting with the key "Type of Biting Selection" (9) . NOTE: The type of biting does not affect the kV and mA values, but it affects the position of the focus layer, by adapting the rotation movement to the patient's anatomy. *

(Rev. 0) I-Max Touch (110-120V) 49 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. 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 "Examination mode selection", the "Adult/Child Selection" (7) and the "Size Selection" (8) keys 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 the following two indications: > x x k V x x m A x x . x s P A N O R A M I C - S T D or x x k V > x x m A x x . x s P A N O R A M I C - S T D The symbol ">" indicates which parameter is being changed. A parameter can be modified by pressing the increase key (3) and the decrease key (4) of that parameter repeatedly. The kV value can vary between 60 and 86 kV, with 2 kV steps. The value of mA can vary between 6 and 10 mA, with 1 mA steps. NOTE: To change the values rapidly, keep the increase key (3) or decrease key (4) pressed. Select the type of mouth with the key "Type of Biting Selection" (9) . *

I-Max Touch (110-120V) (Rev. 0) 50 Panoramic positioning 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 46 Figure 10 Legend of Reference Lines 45 Sagittal medial line 46 Frankfurt plane line

(Rev. 0) I-Max Touch (110-120V) 51 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.). 2. Ask the patient to put on the protective apron, or something similar, making sure that it does not interfere with the trajectory of the X-ray beams. 3. Place the patient in a standing position at the chin support. With the keys "Column movement" (15/16) lift/lower the column until the chin support is aligned with the patient's chin. 4. Position the patient with the temple clasps (Figure 9) ensuring that the chin rests on the special support; the hands should rest on the front handles. Ask the patient 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. 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 in Figure 10). Position the patient's head in such a way as to ensure that the luminous beams fall in correspondence with the respective anatomical references. The luminous beam of the Frankfurt plane can be adjusted according to the patient's height; 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 key "Patient Entrance" (6) is pressed to start the exposure preparation phase. *

I-Max Touch (110-120V) (Rev. 0) 52 7. At this point, the patient must move his feet towards the column, making sure to keep his head within the pre-aligned anatomical references. In this way, you will have 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 collision of the tube-head with the patient's shoulders. Check that the Frankfurt plane is still horizontal. 8. Close the temple clasps (Figure 9) to help the patient keep 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 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: x x k V x x m A x x . x s S T A R T E X A M x = value defined by the settings The green LED "Ready for X-ray" lights up to indicate that pressing the X-ray button once more will start the radiation phase. 10. Ask the patient to: keep the lips closed, bring the tongue towards the palate, keep perfectly still and do not look at the rotating arm during the movements.

(Rev. 0) I-Max Touch (110-120V) 53 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. Once the cycle is completed, deactivate the "Test" function by pressing the key again. 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. 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 correct. If not, correct them as described in paragraph 6.5.2.2; ensure that the machine's indicator light "Ready for X-rays" will come on, so press the X-ray button for the entire duration of the exposure, checking the simultaneous working of the X-ray indicator light "X-rays emission" (if you are within sight of the machine) and the acoustic ray signal. The following message will be displayed first: S T A R T E X A M P R E - H E A T I N G . . . and then (after 2 seconds), the following message will be displayed: x x k V x x m A x x . x s > X - R A Y < x = value defined by the settings NOTE: If the machine is in the "Test" mode, the display will show: T E S T X R A Y N O T A C T I V E * *

I-Max Touch (110-120V) (Rev. 0) 54 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: D I G I T A L S E N S O R I S N O T R E A D Y Refer to the Manual of the Digital Acquisition System to correct the situation. To reset the message on the I-Max Touch, press key . 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. Since the X-ray button is a "dead man’s switch", it must be kept pressed until the end of the 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 free the patient from the positioning device. NOTE: If the examination is made in "Test" mode with the patient already in position, he must not be removed from the temple clasp group, to avoid having to reposition him. Press the "Patient Entrance" (6) key to return the unit to its initial position. This movement can be stopped by pressing the same key. Now the system is ready to perform a new examination. 3. Press the key "Patient Entrance" (6) , the unit will move back to the starting position showing the message: P L E A S E W A I T . . . The Digital Acquisition System will, in the meantime, process the image and display it. * * *

(Rev. 0) I-Max Touch (110-120V) 55 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: T U B E C O O L I N G P L E A S E W A I T x x x s The waiting time allows the anode in the radiogenic tube to cool down. WARNING: After every examination, clean the chin support, the handles and the temple clasps group thoroughly and change the disposable bite protective sleeve. NOTE: If, during the exposure, the patient moves, 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-rays and the movement of the arm. If this occurs, the following message will be displayed: E 2 0 6 P 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 has to be made with great care in order to prevent damage to the machine. Then press the "Patient Entrance" (6) key and the display will show: M A C H I N E S E T T I N G P R E S S > 0 < and then: W A I T F O R M A C H I N E S E T T I N G The system now returns to its initial position and the patient must be repositioned. * *

I-Max Touch (110-120V) (Rev. 0) 56 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. In particular, the chosen value of the kV is lowered in the initial and end sections of the panoramic and increased on the incisors/canine zone. The tube current varies according to the kV, also if the set value is slightly increased on the initial/end sections. These variations have 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 value kV The values displayed during the panoramic examination correspond to the ones chosen by the user, while the real value in the various positions of the examination cycle can be different; in any case, the system guarantees that the accuracy of the exposure parameters is always within the limits set by the international standards for the safety of medical devices, IEC 60601-1. In particular, in accordance with IEC 60601-2-7, the maximum deviation (including the correction according to the above curve and instrumental doubt) is within ±10% for the kV, while for the tube current it is within ± 15%. *

(Rev. 0) I-Max Touch (110-120V) 57 6.6 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. The operation sequence of the examination is therefore identical to the one described for the panoramic. The temporo-mandibular joint examination makes use of a projection geometry giving an image of the X-rayed condyle along a direction almost parallel with its major axis, in order to achieve a clear view of its positioning inside the cavity. This TMJ function enables to obtain 4 different acquisitions on the same image, by performing two rotational 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 same condyle to help a diagnosis. Figure 11 shows the information related to the single sectors. RIGHT condyle with closed mouth 1st exposure RIGHT condyle with open mouth 3rd exposure LEFT condyle with open mouth 4th exposure LEFT condyle with closed mouth 2nd exposure Figure 11 NOTE: During the TMJ examination, the emission of X-rays is intermittent (it is interrupted during the transition phases between the various exposures), but it is necessary to keep the X-ray button pressed for the whole rotation time. Do not release the X-ray button during the emission interruption if not necessary. The cooling phase of the tube-head occurs at the end of all 4 exposures. In the CHILD position, exposure start is delayed by a few degrees with respect to the ADULT position. L R *

I-Max Touch (110-120V) (Rev. 0) 58 6.6.1 Preparation of the device To select the TMJ examination, press key "Examination Mode Selection" (10) until the following message and graphic is displayed: x x k V x x m A 9 . 7 0 s T M J O / C - > C L O S E The system is positioned in the following configuration: • ADULT with the display of the corresponding graphic in the button • MEDIUM SIZE with the display of the corresponding graphic in the button and the display showing the default exposure parameters (if this is the first TMJ 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 placed in position if it has been removed (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. The patient anatomy can differ significantly from the statistical model; based on his experience and competence, the user has to judge this variation. IN ANY CASE, THE RADIOGRAPHY IMAGES CANNOT BE USED TO PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. *

(Rev. 0) I-Max Touch (110-120V) 59 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 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 and mA values already set. NOTE: In the manual mode, the "Anatomic/Manual mode" (13) indicator displays "M" to indicate the manual mode; it is possible to use key (7) to change from Adult to Child. * *

I-Max Touch (110-120V) (Rev. 0) 60 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 visualise the kV and mA settings as in the table. Exposure values in TMJ examination (9.7 sec) Examination Adult Child TMJ mouth closed/open kV mA kV mA Small 68 6 62 6 Medium 72 6 64 6 Large 76 6 66 6 Table 3 The time (9.7 sec.) refers to the sum of the four exposures (2 closed mouth exposures and 2 open mouth exposures).

(Rev. 0) I-Max Touch (110-120V) 61 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. 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 "Examination mode selection", the "Adult/Child Selection" (7) and the "Size Selection" (8) keys 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 the following two indications: > x x k V x x m A 9 . 7 0 s T M J O / C - > C L O S E or x x k V > x x m A 9 . 7 0 s T M J O / C - > C L O S E The symbol ">" indicates which parameter is being changed. A parameter can be modified by pressing the increase key (3) and the decrease key (4) of that parameter repeatedly. The kV value can vary between 60 and 86 kV, with 2 kV steps. The value of mA can vary between 6 and 10 mA, with 1 mA steps. NOTE: To change the values rapidly, keep the increase key (3) or decrease key (4) pressed. *

I-Max Touch (110-120V) (Rev. 0) 62 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.). Ensure that 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 something similar, making 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 column until the chin support plane is aligned with the patient's chin. 4. Position the patient with the temple clasps (Figure 12) asking him to place his hands on the front support. 1 3 4 45 46 Figure 12 - TMJ closed mouth positioning Legend of Reference Lines 45 Sagittal medial line 46 Frankfurt plane line Legend positioning devices and patient centring 1 SINUS/TMJ support 3 Temple clasps - Forehead support 4 Temple clasps - Forehead support release knobs

(Rev. 0) I-Max Touch (110-120V) 63 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 in Figure 10). Position the patient's head in such a way as to ensure that the luminous beams fall in correspondence with the respective anatomical references. The luminous beam of the Frankfurt plane can be adjusted according to the patient's height; 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 key "Patient Entrance" (6) is pressed to start the exposure. 7. Close the temple clasps and bring the forehead support close; this will help the patient to stay in a correct position. Check that, during this phase, the patient has not changed position. 8. 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: x x k V x x m A 9 . 7 0 s S T A R T E X A M x = value defined by the settings The green LED "Ready for X-ray" lights up to indicate that pressing the X-ray button once more will start the radiation phase. 9. Ask the patient to: keep the lips closed, keep perfectly still and do not look at the rotating arm during the movements. *

I-Max Touch (110-120V) (Rev. 0) 64 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. 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). NOTE: If deemed necessary, it is possible to check the interference of the rotation movement with the shoulder of the patient; it is possible, by pressing 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. 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 corresponding to the open mouth exam. Once the cycle is completed, deactivate the "Test" function by pressing the key again. 1. Check once again that the exposure data are correct. If not, correct them as described in paragraph 6.6.2.2. ensure that the machine's indicator light "Ready for X-ray" will come on, so press the X-ray button for the entire duration of the exposure, checking the simultaneous working of the ray indicator light "X-ray emission" (if you are within sight of the machine) and the acoustic ray signal. The following message will be displayed first: S T A R T E X A M P R E - H E A T I N G . . . and then (after 2 seconds), the following message will be displayed: x x k V x x m A 9 . 7 0 s > X - R A Y < x = value defined by the settings NOTE: If the machine is in the "Test" mode, the display will show: T E S T X R A Y N O T A C T I V E * *

(Rev. 0) I-Max Touch (110-120V) 65 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: D I G I T A L S E N S O R I S N O T R E A D Y Refer to the Manual of the Digital Acquisition System to correct the situation. To reset the message on the I-Max Touch, press key . NOTE: The rotation of the arm and the emission of the X-rays will start with a delay of 2 seconds from pressing the X-ray button. As the X-ray button is a "dead man's switch", it is necessary to keep 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 also suspended. 2. Once the exposure is completed, the system will carry out a short return rotation and the following message will be displayed: P A T I E N T E X I T P R E S S > 0 < It will then be possible to set up the system for the open mouth examination, keeping the patient in position or releasing him from the working area. 3. Press the key "Patient Entrance" (6) . The machine will reposition itself back to the starting position displaying the message: P L E A S E W A I T . . . The end of the movement, the display will show the message: I N S T R U C T P A T I E N T T O O P E N M O U T H ! * *

I-Max Touch (110-120V) (Rev. 0) 66 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: I N S T R U C T P A T I E N T T O O P E N M O U T H ! 2. Press the key "Patient Entrance" (6) to confirm. The following message will be displayed: 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 in position using appropriate mechanical devices - not supplied - if necessary) and keep his chin touching the SINUS/TMJ chin support rest. 1 3 4 45 Figure 13 - Open mouth examination positioning Legend of Reference Lines 45 Sagittal medial line Legend positioning devices and patient centring 1 SINUS/TMJ chin support 3 Temple clasps - Forehead support 4 Temple clasps - Forehead support release knobs

(Rev. 0) I-Max Touch (110-120V) 67 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 (Figure 10). Using as reference the sagittal medial plane laser, position the patient's head in such a way that the sagittal medial plane is lit by the corresponding laser beam 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 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. 6. Close the temple clasps and bring the forehead support close; this will help the patient to stay in a correct position. Check that, during this phase, the patient has not changed position. 7. Advise the patient to remain perfectly still and not look at the rotating arm during the movements. *

I-Max Touch (110-120V) (Rev. 0) 68 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. 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). WARNING: Using the laser centring devices, check that 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 data are correct (see paragraph 6.6.2). NOTE: The Adult/Child and Size small - medium - large selection keys are deactivated. The exposure parameters can be changed as described in paragraph 6.6.2. Press the X-ray button for the entire duration of the exposure, checking the concurrent working of the ray indicator light "X-ray emission" (if you are within sight of the machine) and the acoustic ray signal. The following message will be displayed first: S T A R T E X A M P R E - H E A T I N G . . . and then (after 2 seconds), the following message will be displayed: x x k V x x m A 9 . 7 0 s > X - R A Y < x = value defined by the settings *

(Rev. 0) I-Max Touch (110-120V) 69 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. 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 also suspended. 2. Once the exposure is completed, the system will rotate back. When it has completed this manoeuvre, 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 free the patient from the positioning device. 3. Press the "Patient Entrance" (6) key ; the machine will return to the patient entry position and the following message will be displayed: P L E A S E W A I T . . . WARNING: After every examination, clean the chin support, the handles and the temple clasps group thoroughly. *

I-Max Touch (110-120V) (Rev. 0) 70 NOTE: If, during the exposure, the patient moves, 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-rays and the movement of the arm. If this occurs, the following message will be displayed: E 2 0 6 P 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 in order to prevent damage to the machine. Then press the "Patient Entrance" (6) key and the display will show: M A C H I N E S E T T I N G P R E S S > 0 < and then: W A I T F O R M A C H I N E S E T T I N G The system now returns to its initial position and the patient must be repositioned. NOTE: If the open mouth exposure is not completed, the closed mouth exposure must be repeated or the four complete pictures will not appear. * *

(Rev. 0) I-Max Touch (110-120V) 71 6.7 SINUS examination To select the SINUS 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, one single rotation of the rotating arm is to be expected, with the X-rays emission limited to the interested area.

I-Max Touch (110-120V) (Rev. 0) 72 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 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 and mA values already set. NOTE: In the manual mode, the "Anatomic/Manual mode" (13) indicator displays "M" to indicate the manual mode; it is possible to use key (7) to change from Adult to Child. * *

(Rev. 0) I-Max Touch (110-120V) 73 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 visualise the kV and mA settings as in the table. Exposure values in SINUS examination (9.4 sec) Adult Child kV mA kV mA Small 66 6 62 6 Medium 70 6 64 6 Large 72 6 66 6 Table 4

I-Max Touch (110-120V) (Rev. 0) 74 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. 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 "Examination mode selection", the "Adult/Child Selection" (7) and the "Size Selection" (8) keys 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 the following two indications: > x x k V x x m A 9 . 4 0 s S I N U S or x x k V > x x m A 9 . 4 0 s S I N U S The symbol ">" indicates which parameter is being changed. A parameter can be modified by pressing the increase key (3) and the decrease key (4) of that parameter repeatedly. The kV value can vary between 60 and 86 kV, with 2 kV steps. The value of mA can vary between 6 and 10 mA, with 1 mA steps. NOTE: To change the values rapidly, keep the increase key (3) or decrease key (4) pressed. *

(Rev. 0) I-Max Touch (110-120V) 75 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.). 2. Ask the patient to put on the protective apron, or something similar, making 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) raise/lower the column until the chin support rest is aligned with the patient's chin. 4. Position the patient with the temple clasps (Figure 14) ensuring that the chin rests on the special support; ask the patient to place his hands on the front supports. Ensure that the patient rests his chin on the chin support for SINUS/TMJ. 1 3 4 45 46 Figure 14 - SINUS positioning Legend of Reference Lines 45 Sagittal medial line 46 Frankfurt plane line Legend positioning devices and patient centring 1 SINUS/TMJ chin support 3 Temple clasps - Forehead support 4 Temple clasps - Forehead support release knobs

I-Max Touch (110-120V) (Rev. 0) 76 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 in Figure 10). Position the patient's head in such a way as to ensure that the first two luminous beams fall in correspondence with the respective anatomical references. The luminous beam of the Frankfurt plane can be adjusted according to the patient's height; 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 key "Patient Entrance" (6) is pressed to start the exposure. 7. Close the temple clasps and bring the forehead support close; this will help the patient to stay in a correct position. Check that, during this phase, the patient has not changed position. 8. Press the key "Patient Entrance" (6) to confirm. 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: x x k V x x m A 9 . 4 0 s S T A R T E X A M x = value defined by the settings 9. Ask the patient to: close his mouth, remain perfectly still and not look at the rotating arm during the movement. *

(Rev. 0) I-Max Touch (110-120V) 77 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. 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). NOTE: Before performing a lateral Sinus examination, because of the specific trajectory described by the rotating arm, it is recommended to check for possible mechanical interferences with the patient's shoulder during the rotation. By pressing 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 is completed, deactivate the "Test" function by pressing the key again. 1. Verify once again that the exposure data are correct. If not, correct them as described in paragraph 6.5.2.2; ensure that the machine's indicator light "Ready for X-ray" will come on, so press the X-ray button for the entire duration of the exposure, checking the simultaneous working of the ray indicator light "X-ray emission" (if you are within sight of the machine) and the acoustic ray signal. The following message will be displayed first: S T A R T E X A M P R E - H E A T I N G . . . and then (after 2 seconds), the following message will be displayed: x x k V x x m A 9 . 4 0 s > X - R A Y < x = value defined by the settings NOTE: If the machine is in the "Test" mode, the display will show: T E S T X R A Y N O T A C T I V E * *

I-Max Touch (110-120V) (Rev. 0) 78 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: D I G I T A L S E N S O R I S N O T R E A D Y Refer to the Manual of the Digital Acquisition System to correct the situation. To reset the message on the I-Max Touch, press key . 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. 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 also suspended. 2. Once the exposure is completed, the system will rotate back. When it has completed this manoeuvre, 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 free the patient from the positioning device. 3. Press the key "Patient Entrance" (6) . The machine will reposition itself back to the starting position displaying the message: P L E A S E W A I T . . . At the end, the following message 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 that shows the values set for that last exposure. A new exposure can now be made. * *

(Rev. 0) I-Max Touch (110-120V) 79 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: T U B E C O O L I N G P L E A S E W A I T x x x s The waiting time allows the anode in the radiogenic tube to cool down. WARNING: After every examination, clean the chin support, the handles and the temple clasps group thoroughly. NOTE: If, during the exposure, the patient moves, 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-rays and the movement of the arm. If this occurs, the following message will be displayed: E 2 0 6 P 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 in order to prevent damage to the machine. Then press the "Patient Entrance" (6) key and the display will show: M A C H I N E S E T T I N G P R E S S > 0 < and then: W A I T F O R M A C H I N E S E T T I N G The system now returns to its initial position and the patient must be repositioned. * *

I-Max Touch (110-120V) (Rev. 0) 80 6.8 Cephalometric examination There is no rotation of the tube-head (X-ray generator) support arm and sensor holder for the cephalometric examination. Various projections are possible for the cephalometric examination. On the basis of the image format selected and the projection chosen, the primary diaphragm will automatically place itself in the correct position, at the same time as the secondary collimator and the digital sensor. The Cephalometric examination is fitted with a 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-Max Touch makes different kinds of exposures, according to the type of selection made: 18x22 Asymmetric for Latero-Lateral (L.L.) 24x22 Symmetric for Posterior- Anterior (P.A.) and Antero- Posterior (A.P.) 24x22 Asymmetric for Latero-Lateral (L.L.) 30x22 Symmetric for Latero-Lateral (L.L.) 18x22 Symmetric for assessment of bone growth (A.P.) For all these formats, it is possible to carry out the examination in High Resolution (h) or Normal Resolution (n). It also possible to carry out the examination to assess bone growth, following the instructions in paragraph 6.9 below.

(Rev. 0) I-Max Touch (110-120V) 81 6.8.1 Preparation of the device To select the CEPH examination, press key "Examination Mode Selection" (10) until the following message and graphic is displayed: x x k V x x m A 4 . 5 0 s C E 1 8 x 2 2 L L n 8 . 5 x = value defined by the settings 1. Press the "Patient Entrance" (6) key ; the display will show alternatively the following messages: C E P H - R E M O V E C H I N R E S T and C E P H - C L O S E T E M P L E S U P P O R T The first message tells the operator 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 when the arm is being positioned. WARNING: Neither of the two messages are controlled by the system and they can therefore appear even if the unit has been set correctly, until the "Patient Entrance" (6) key is pressed. WARNING: There is no need to position any type of chin support for the cephalometric examination. The chin support used for panoramic examinations must be removed as indicated on the display. If the chin support is not removed, it will collide with the sensor holder during alignment and can obscure some anatomical parts of the patient during the examination. At the same time, the temple clasps must be closed, in order to avoid collision with the rotating arm.

I-Max Touch (110-120V) (Rev. 0) 82 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: A X I S P O S I T I O N I N G P L E A S E W A I T . . . NOTE: In case of a single sensor unit, if the sensor holder is in PAN position, once the alignment is completed, the following message will be displayed: R E M O V E S E N S O R I N P A N S L O T Move the 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 following message will be displayed: C E P H - O P E N C A S S E T T E H O L D E R requesting the operator to open the sensor holder for panoramic examination. NOTE: The position of the sensor holder for panoramic examination is controlled by two micro-switches, it must therefore be completely opened. The following message will be displayed: x x k V x x m A 4 . 5 0 s C E 1 8 x 2 2 L L n 8 . 5 This message indicates the image format predefined by the system; the letter "n" after the format indicates that the execution will be in Normal Resolution. * * *

(Rev. 0) I-Max Touch (110-120V) 83 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 viceversa. Pressing twice the key (10) the unit will return to PANORAMIC STD position; the display shows: C O N F I M P A N ? > 0 < = S , T = N Pess the "Patient Entrance" (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 obtaining an image of sufficient quality for the orthodontic diagnostics, albeit with a spatial resolution lower compared with that obtained from High Resolution images. NOTE: The system is positioned in the following configuration: • ADULT with the display of the corresponding graphic in the button • MEDIUM SIZE with the display of the corresponding graphic in the button. The key "Type of Biting Selection" (9) is disabled. 3. By means of the keys "Arrow right" (12) and "Arrow left" (11) select the dimensions of the image and the type of projection (see the table at the beginning of the Chapter). * *

I-Max Touch (110-120V) (Rev. 0) 84 6.8.2 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 choise of resolution, 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 type of patient and size; Soft Tissue Filter in default position • MANUAL: with the possibility of changing the kV, mA and Soft Tissue Filter values set (mm). NOTE: In the manual mode, the "Anatomic/Manual mode" (13) indicator displays "M" to indicate the manual mode; it is possible to use key (7) to change from Adult to Child. * *

(Rev. 0) I-Max Touch (110-120V) 85 6.8.2.1 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 per the following tables: Adult Child kV mA kV mA Small 66 6 62 6 Medium 70 6 64 6 Large 72 6 66 6 Table 5: Latero-Lateral projection Adult Child kV mA kV mA Small 74 12 70 10 Medium 76 12 72 10 Large 80 10 74 10 Table 6: Antero-Posterior projection

I-Max Touch (110-120V) (Rev. 0) 86 6.8.2.2 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. NOTE: It will be possible to modify manually kV, mA and Soft Tissue Filter position (mm). The "mm" value in the exposure parameters and parameter "fxx.x" in the display indicate the position of the STF; it has to be adjusted according to the value read on the graduate scale present on the nose rest (Figure 15). To modify the kV, mA and STF values, press any of the up (3) or down (4) arrows of the KV, mA or mm parameters, the blue frames around the "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/Manual mode" indicator will display "M". The display will show respectively one of the following three indications: > x x k V x x m A x x . x s C E 1 8 x 2 2 L L n 8 . 5 x x k V > x x m A x x . x s C E 1 8 x 2 2 L L n 8 . 5 x x k V x x m A > f x x . x C E 1 8 x 2 2 L L n 8 . 5 The symbol ">" indicates which parameter is being changed. A parameter can be modified by pressing the increase key (3) and the decrease key (4) of that parameter repeatedly. The "kV" value can vary between 60 and 80 kV, with 2 kV steps. The "mA" value can vary between 4 and 12 mA, with 1 mA steps. The "Soft Tissue Filter" value can vary between 6 and 10.5 cm, with 0.1 cm steps. NOTE: To change the values rapidly, keep the increase key (3) or decrease key (4) pressed. * *

(Rev. 0) I-Max Touch (110-120V) 87 6.8.3 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.). 2. Ask the patient to put on the protective apron, or something similar, making sure that it does not interfere with the trajectory of the X-ray beams. 3. Open the ear centring device (Figure 15) to its maximum span by using the upper part of the rods of the centring 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 the ear centring device (Figure 15). 4. Position the patient upright near the auricular centring device. With the keys "Column movement" (15/16) lift/lower, the column till the centring pins (Figure 15) are close to the ear to clasp the patient's head so that the pivots penetrate the ear (Figure 15) moving the upper part of the rods. If a Latero-Lateral examination is performed, position the nose rest. 5. By selecting an "asymmetric" projection, the Soft Tissues Filter (STF) will be automatically inserted. 2 3 1 4 Figure 15 Legend 1 Nose rest 2 Ear centring device 3 Pins for ear centring device 4 Nose rest graduate scale

I-Max Touch (110-120V) (Rev. 0) 88 6.8.4 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. 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 Figure 1 and Figure 2). 1. Verify once again that the exposure data are correct (see paragraph 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 selected examination start position. The signalling LED "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 duration of the exposure, checking the concurrent working of the ray indicator light "X-ray emission" (if you are within sight of the machine) and the acoustic ray signal. The following message will be displayed first: S T A R T E X A M P R E - H E A T I N G . . . and then (after 2 seconds), the following message will be displayed: x x k V x x m A x . x x s > X - R A Y < x = value defined by the settings *

(Rev. 0) I-Max Touch (110-120V) 89 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: D I G I T A L S E N S O R I S N O T R E A D Y Refer to the Manual of the Digital Acquisition System to correct the situation. To reset the message on the I-Max Touch, press key . 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. 3. Once the exposure is completed, the secondary collimator moves into a back resting position, to allow the patient to come out. The display will again show all the exposure values relating to the exposure just completed. 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 before carrying out the new test: T U B E C O O L I N G P L E A S E W A I T x x x s This time enables the X-ray tube's anode to cool down. * * *

I-Max Touch (110-120V) (Rev. 0) 90 NOTE: If the patient moves during the exposure, or if you realise 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 message will be displayed: E 2 0 6 P R E S S > 0 < Then press the "Patient Entrance" (6) key . The system now returns to the position for Ceph exam and the unit starts the procedure for the new examination. NOTE: After every examination, clean the ear centring device and temple clasps group thoroughly. * *

(Rev. 0) I-Max Touch (110-120V) 91 6.9 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. The image format set in order to carry out this examination is 18x22 Symmetric, not adjustable; it is therefore necessary to position the auricular rods and the nose-rest as for the cephalometric Antero- Posterior examination, so that these elements do not interfere with the X-ray trajectory. Refer to Figure 16.

I-Max Touch (110-120V) (Rev. 0) 92 6.9.1 Preparation of the device 1. Select the CEPH examination, pressing key "Examination Mode Selection" (10) until the following message and graphic is displayed: x x k V x x m A 4 . 5 0 s C E 1 8 x 2 2 L L n 8 . 5 x = value defined by the settings 2. By means of the keys "Arrow right" (12) and "Arrow left" (11) select the CARPUS examination: x x k V x x m A 4 . 5 0 s C A R P U S 1 8 x 2 2 n 3. Press the "Patient Entrance" (6) key ; the display will show alternatively the following messages: C E P H - R E M O V E C H I N R E S T and C E P H - C L O S E T E M P L E S U P P O R T The first message tells the operator 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 when the arm is being positioned. WARNING: Neither of the two messages are controlled by the system and they can therefore appear even if the unit has been set correctly, until the "Patient Entrance" (6) key is pressed. WARNING: There is no need to position any type of chin support for the Carpus examination. The chin support used for panoramic examinations must be removed as indicated on the display. If the chin support is not removed, it will collide with the sensor holder during alignment and can obscure some anatomical parts of the patient during the examination. At the same time, the temple clasps must be closed, in order to avoid collision with the rotating arm.

(Rev. 0) I-Max Touch (110-120V) 93 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: A X I S P O S I T I O N I N G P L E A S E W A I T . . . NOTE: In case of a single sensor unit, if the sensor holder is in PAN position, once the alignment is completed, the following message will be displayed: R E M O V E S E N S O R I N P A N S L O T Move the 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 following message will be displayed: C E P H - O P E N C A S S E T T E H O L D E R requesting the operator to open the sensor holder for panoramic examination. NOTE: The position of the sensor holder for panoramic examination is controlled by two micro-switches, it must therefore be completely opened. The following message will be displayed: x x k V x x m A 4 . 5 0 s C A R P U S 1 8 x 2 2 n This message indicates the image format predefined by the system; the letter "n" after the format indicates that the execution will be in Normal Resolution. * * *

I-Max Touch (110-120V) (Rev. 0) 94 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 viceversa. Pressing twice the key (10) the unit will return to PANORAMIC STD position; the display shows: C O N F I M P A N ? > 0 < = S , T = N Pess the "Patient Entrance" (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 obtaining an image of sufficient quality for the orthodontic diagnostics, albeit with a spatial resolution lower compared with that obtained from High Resolution images. 5. Regulate the exposure parameters as required, using the pre-set values or manual selection; the display will show the kV and mA settings as per the following table. Child kV mA Small 60 6 Medium 60 6 Large 60 6 Table 7 *

(Rev. 0) I-Max Touch (110-120V) 95 6.9.2 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 plastic positioning support for hand projection. 3. Place the patient 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 irradiated area. The horizontal line should help the vertical adjustment of the hand. The common radiological procedure to assess bone growth in children, suggests placing the end of the middle finger tangent to the reference line. The patient's hand and arm must form a vertical line. Figure 16