Owandy Radiology i-max touch User manual
SERVICE MANUAL 0051
Revision 4 - July 2014
I-Max Touch / I-Max Touch 3D Service Manual
The manufacturer OWANDY RADIOLOGY reserves the right to make modifications to its products or to their
specifications in order to improve the performance, quality, or ease of production. Specifications of products or
accessories may be modified without prior notice.
No part of this publication can be reproduced, transmitted, transcribed or translated without the approval of
OWANDY RADIOLOGY
This manual is the English translation of the original Italian manual version.
0051
Year in which the CE marking was affixed: 2010
OWANDY RADIOLOGY
2 rue des Vieilles Vignes
77183 Croissy-Beaubourg, FRANCE
Tel. (+33) 1 64 11 18 18
Fax (+33) 1 64 11 18 10
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Contents
1.INTRODUCTION ................................................................................................................................... 7
1.1Description of the system .................................................................................................................. 8
1.2Physical principles of operation ......................................................................................................... 8
1.3Image acquisition on the I-Max Touch 3D......................................................................................... 9
1.4Icons appearing in the manual .......................................................................................................... 9
2.USABILITY .......................................................................................................................................... 10
2.1Training ............................................................................................................................................ 10
2.2Patient profile................................................................................................................................... 10
2.3Prescription use statement (USA) ................................................................................................... 10
2.4Indications for use............................................................................................................................ 10
3.SAFETY INFORMATION..................................................................................................................... 11
3.1Applicable safety regulations........................................................................................................... 11
3.1.1Standards................................................................................................................................. 11
3.1.2Classifications .......................................................................................................................... 12
3.2Warnings.......................................................................................................................................... 13
3.2.1Distribution of stray radiation (I-Max Touch 3D only) .............................................................. 16
3.2.2Electromagnetic emissions ...................................................................................................... 16
3.2.3Electromagnetic immunity........................................................................................................ 17
3.2.4Recommended separation distances for non-life supporting equipment ................................ 18
3.3Environmental risks and disposal .................................................................................................... 20
3.4Symbols used .................................................................................................................................. 21
4.DESCRIPTION .................................................................................................................................... 22
4.1Identification plates and laser labels................................................................................................ 22
4.1.1Identification plates and laser labels locations I-Max Touch ................................................... 22
4.1.2Identification plates and laser labels I-Max Touch 110-120V.................................................. 23
4.1.3Identification plates and laser labels I-Max Touch 220-240V.................................................. 24
4.1.4Identification plates and laser labels locations I-Max Touch 3D.............................................. 25
4.1.5Identification plates and laser labels I-Max Touch 3D 110-120V ............................................ 26
4.1.6Identification plates and laser labels I-Max Touch 3D 220-240V ............................................ 27
4.2Functions, models and versions ...................................................................................................... 28
4.2.1Standard version...................................................................................................................... 28
4.2.2Version with cephalometric arm............................................................................................... 29
4.3Block diagram .................................................................................................................................. 29
4.3.1I-Max Touch block diagram ..................................................................................................... 30
4.3.2I-Max Touch 3D block diagram................................................................................................ 31
4.3.3Power supply assembly ........................................................................................................... 32
4.3.4CPU Board (A5 and A6) .......................................................................................................... 32
4.3.5Generator Board (A10) and Tubehead.................................................................................... 34
4.3.6Control panel with electronic board (A4) ................................................................................. 34
4.4Control panel layout......................................................................................................................... 35
4.4.1Standard user interface ........................................................................................................... 35
4.4.2Acquired image interface (I-Max Touch only).......................................................................... 36
4.4.3Technical interface................................................................................................................... 37
5.TECHNICAL CHARACTERISTICS ..................................................................................................... 38
5.1Technical datasheets....................................................................................................................... 38
5.2Dimensions ...................................................................................................................................... 43
5.2.1Dimensions I-Max Touch ......................................................................................................... 43
5.2.2Dimensions I-Max Touch 3D ................................................................................................... 45
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5.3Loading curve tube and cooling curve anode.................................................................................. 47
5.4Accessories...................................................................................................................................... 48
5.5Measurement method technical factors........................................................................................... 49
5.5.1Invasive method....................................................................................................................... 49
5.5.2Non-invasive method ............................................................................................................... 49
5.6Technical service programs............................................................................................................. 50
5.6.1Accessing technical service menus......................................................................................... 50
5.6.2Control panel service mode ..................................................................................................... 51
5.6.3CONFIGURATION menu (password 92)................................................................................. 52
5.6.4AXIS ALIGNMENT menu (password 118)............................................................................... 60
5.6.5CEPH SETTINGS menu (password 124)................................................................................ 63
5.6.6TROUBLESHOOTING menu (password 112)......................................................................... 66
5.6.7SYSTEM menu ........................................................................................................................ 70
5.6.8BURN-IN menu........................................................................................................................ 70
5.6.9SHOW CONFIGURATION menu ............................................................................................ 71
5.6.10Touch screen calibration.......................................................................................................... 71
6.PRE-INSTALLATION........................................................................................................................... 72
6.1Electrical setup ................................................................................................................................ 72
6.2Packaging ........................................................................................................................................ 74
6.3Space requirements......................................................................................................................... 75
6.3.1Standard version without Ceph option..................................................................................... 75
6.3.2Version with Ceph option......................................................................................................... 76
6.4Computer requirements ................................................................................................................... 77
6.4.1I-Max Touch computer requirements....................................................................................... 77
6.4.2I-Max Touch 3D computer requirements ................................................................................. 77
7.INSTALLATION ................................................................................................................................... 79
7.1Preparation wall ............................................................................................................................... 79
7.2Column mounting............................................................................................................................. 80
7.2.1Unpacking column / ceph arm ................................................................................................. 80
7.2.2Mounting the column ............................................................................................................... 84
7.3Mounting of the head (rotating arm assembly)................................................................................ 86
7.3.1Unpacking the head................................................................................................................. 86
7.3.2Mounting the head ................................................................................................................... 88
7.4Mounting of ceph arm (optional)...................................................................................................... 91
7.5How to mount the covers ................................................................................................................. 93
7.6Inserting sensor in sensor holder .................................................................................................... 94
7.7Computer installation ....................................................................................................................... 94
7.7.1Installation I-Max Touch computer and network...................................................................... 94
7.7.2Installation I-Max Touch 3D computer and network ................................................................ 95
7.7.3Installation O.S.P. (drivers)...................................................................................................... 95
7.7.4Installation 3D sensor calibration files ..................................................................................... 99
7.7.5Installation pan and ceph sensor calibration files.................................................................. 100
7.7.6Installation imaging software ................................................................................................. 100
7.8Final installation checks................................................................................................................. 100
7.8.1Verification computer setup ................................................................................................... 100
7.8.2Verification firmware versions................................................................................................ 101
7.8.3Verification panoramic function.............................................................................................. 101
7.8.4Verification 3D function.......................................................................................................... 102
7.8.5Verification ceph function....................................................................................................... 103
7.8.6Verification exposure parameters - Invasive method ............................................................ 107
7.8.7Verification exposure parameters - Non-invasive method..................................................... 109
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7.8.8Storing of personalised automatic exposure parameters ...................................................... 110
7.9Test acquisitions ............................................................................................................................ 111
7.9.1Acquisition pan/cephalometric test image ............................................................................. 111
7.9.2Acquisition 3D test volume (I-Max Touch 3D only)................................................................ 111
7.9.3Manual reconstruction 3D volume (I-Max Touch 3D only) .................................................... 112
8.TROUBLESHOOTING....................................................................................................................... 113
8.1LEDs .............................................................................................................................................. 113
8.1.1LED generator board A10...................................................................................................... 113
8.1.2LED CPU board A5................................................................................................................ 114
8.2Display messages.......................................................................................................................... 115
8.2.1Error codes E000 to E199 ..................................................................................................... 117
8.2.2Error codes E200 to E299 ..................................................................................................... 118
8.2.3Error codes E300 to E399 ..................................................................................................... 120
8.2.4Error codes E400 to E499 ..................................................................................................... 123
8.2.5Error codes E700 to E799 ..................................................................................................... 123
8.2.6Error codes E800 and E801 .................................................................................................. 126
8.2.7Error codes E831 (I-Max Touch 3D only) .............................................................................. 127
8.2.8Error codes E850, E851 and E852........................................................................................ 127
9.MAINTENANCE................................................................................................................................. 128
9.1Service tools .................................................................................................................................. 129
9.2Periodic 3D sensor calibration (I-Max Touch 3D only) .................................................................. 129
9.3Procedure for sensor or tubehead replacement............................................................................ 133
9.3.1Sensor replacement............................................................................................................... 133
9.3.2Panoramic X-ray beam centering verification (I-Max Touch only)......................................... 133
9.3.3Panoramic X-ray beam centering verification (I-Max Touch 3D only)................................... 136
9.3.43D image adjustment (I-Max Touch 3D only) ........................................................................ 141
9.4Procedure CPU board replacement .............................................................................................. 142
9.5Procedure ceph arm alignment ..................................................................................................... 143
9.5.1Alignment ear rings................................................................................................................ 144
9.5.2Ceph sensor centering........................................................................................................... 147
9.5.3Secondary collimator centering ............................................................................................. 148
9.5.4Soft Tissue Filter (STF) adjustment....................................................................................... 150
9.6Procedure computer replacement and software update ............................................................... 152
10.SCHEMATICS AND DRAWINGS I-MAX TOUCH............................................................................. 152
10.1General diagram ............................................................................................................................ 153
10.2Layout column CPU board A1 ....................................................................................................... 162
10.3Circuit diagram column CPU board A1.......................................................................................... 163
10.4Layout control panel board A4....................................................................................................... 166
10.5Layout CPU board A5.................................................................................................................... 167
10.6Circuit diagram CPU board A5 ...................................................................................................... 168
10.7Layout microprocessor board A6................................................................................................... 177
10.8Circuit diagram microprocessor board A6 ..................................................................................... 178
10.9Layout and circuit diagram rotation arm board A7 ........................................................................ 182
10.10Layout generator CPU board A9 ................................................................................................... 183
10.11Circuit diagram generator CPU board A9...................................................................................... 184
10.12Layout generator board A10.......................................................................................................... 186
10.13Circuit diagram generator board A10 ............................................................................................ 187
10.14Layout and circuit diagram ceph arm connection board A12 ........................................................ 190
10.15Layout DSPU board A14 ............................................................................................................... 191
11.SCHEMATICS AND DRAWINGS I-MAX TOUCH 3D ....................................................................... 192
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11.1General diagram ............................................................................................................................ 193
11.2Layout column CPU board A1 ....................................................................................................... 202
11.3Circuit diagram column CPU board A1.......................................................................................... 203
11.4Layout keyboard board A4............................................................................................................. 206
11.5Layout CPU board A5.................................................................................................................... 207
11.6Circuit diagram CPU board A5 ...................................................................................................... 208
11.7Layout microprocessor board A6................................................................................................... 217
11.8Circuit diagram microprocessor board A6 ..................................................................................... 218
11.9Layout and circuit diagram rotation arm board A7 ........................................................................ 222
11.10Layout generator CPU board A9 ................................................................................................... 223
11.11Circuit diagram generator CPU board A9...................................................................................... 224
11.12Layout generator board A10.......................................................................................................... 226
11.13Circuit diagram generator board A10 ............................................................................................ 227
11.14Layout and circuit diagram ceph arm connection board A12 ........................................................ 230
11.15Layout power hub board A21......................................................................................................... 231
11.16Circuit diagram power hub board A21 ........................................................................................... 232
11.17Layout VDSIB board A22............................................................................................................... 233
11.18Circuit diagram VDSIB board A22 ................................................................................................. 234
11.19Layout DSPU board A14 ............................................................................................................... 245
12.SPARE PARTS I-MAX TOUCH......................................................................................................... 246
12.1Column........................................................................................................................................... 246
12.1.1Electrical and mechanical parts ............................................................................................. 246
12.1.2Cables.................................................................................................................................... 246
12.2Head assembly .............................................................................................................................. 248
12.2.1Cables.................................................................................................................................... 248
12.2.2Electrical and mechanical parts ............................................................................................. 248
12.2.3Rotation arm .......................................................................................................................... 250
12.3Ceph arm (S/N ≤10020532).......................................................................................................... 252
12.4Ceph arm (S/N ≥10020533).......................................................................................................... 254
12.5Covers............................................................................................................................................ 256
12.5.1Accessories and service tools ............................................................................................... 258
13.SPARE PARTS I-MAX TOUCH 3D ................................................................................................... 260
13.1Column........................................................................................................................................... 260
13.1.1Electrical and mechanical parts ............................................................................................. 260
13.1.2Cables.................................................................................................................................... 260
13.2Head assembly .............................................................................................................................. 262
13.2.1Cables.................................................................................................................................... 262
13.2.2Electrical and mechanical parts ............................................................................................. 262
13.2.3Rotation arm .......................................................................................................................... 264
13.2.4Ceph arm ............................................................................................................................... 266
13.2.1Covers.................................................................................................................................... 268
13.2.2Accessories and service tools ............................................................................................... 270
14.APPENDICES.................................................................................................................................... 272
14.1Appendix A: Table of preset anatomic parameters ....................................................................... 272
14.1Appendix B: Setup parameters table............................................................................................. 274
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1. INTRODUCTION
NOTE: The present manual is updated for the product it is sold with in order to
guarantee an adequate reference to perform diagnostics and repairs normally carried out by
the service engineer. The manual may not reflect changes to the product not impacting
service operations.
This manual provides the instructions for proper and safe installation and maintenance of the appliance by
technical personnel.
This manual is limited to the description of the radiographic equipment; the instructions for the image
acquisition, manipulation and processing are given in the user manual supplied with the imaging software
used with the I-Max Touch or I-Max Touch 3D unit.
WARNING:
1. The I-Max Touch/I-Max Touch 3D 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.
2. The device must be used in compliance with the procedures described, and never be
used for purposes different from those herewith indicated.
3. The user is liable with regards to the legal fulfillment related to the installation and the
operation of the device.
For any technical queries please contact the technical service of your vendor.
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1.1 Description of the system
The I-Max Touch produced by Owandy Radiology is a complete panoramic system that allows for the
acquisition of all X-ray examinations commonly used in dentistry and orthodontics (excluding intraoral
radiographs): Panoramic, Emi-panoramic, Reduced dose Panoramic, Frontal dentition, Improved
orthogonality Panoramic, Bitewing, Sinus, TMJ and Implant examinations of the maxillo-facial complex.
The evolution of panoramic X-ray units now provides, in addition to traditional methods of examination
(Panoramic, TMJ, Sinus, etc.), the use of three-dimensional images of the patient's maxillofacial complex.
This allows the doctor to investigate a targeted selection of the patient's mouth and to use it both during the
planning phase of the treatment as well as a diagnostic aid. The I-Max Touch 3D produced by Owandy
Radiology is a complete panoramic system that allows for the acquisition of all X-ray examinations commonly
used in dentistry and orthodontics (excluding intraoral radiographs) and also allows the acquisition of
volumetric tomographic, or 3D, X-rays. In this type of device the linear digital sensor traditionally used in the
digital panoramic X-rays has been replaced by a wide range digital sensor also known as a flat panel. These
sensors allow for the capture of an area of the maxillofacial complex that includes the most important
anatomical details by acquiring a series of two-dimensional images (imaging) and reconstructing it with a
computer.
These options are available for the I-Max Touch and I-Max Touch 3D and must be ordered separately:
Digital ceph; allows the acquisition of the following exams, available in High Resolution mode or
Normal Resolution (high speed):
oCeph exam in different formats.
oCarpus exam.
1.2 Physical principles of operation
The I-Max Touch (2D) unit uses a CCD sensor that converts the amount of dose that affects every single
sensor element (pixel) into an electrical signal that can be processed through an analog-digital conversion
system. The digital CCD system of the I-Max Touch is designed by Owandy Radiology.
The I-Max Touch 3D uses the Varian PaxScan 1313DX wide range digital system, used for the acquisition of
3D and panoramic type images. The flat panel sensor functions as a normal digital sensor. Unlike traditional
sensors used for panoramic exams that normally return one image column at a time, the flat panel returns
the entire contents of the sensor. Special functions inside the sensor also allow the acquisition of a specific
part of the sensor, functioning as a normal digital sensor. The system must be connected to a dedicated
computer, on which is installed all the software needed for image acquisition, processing and display. The
resulting images are stored in the system's database in correspondence with the selected patient.
The cephalometric images on the I-Max Touch or I-Max Touch 3D are obtained using a cephalometric digital
system designed by Owandy, similar to that for the panoramic acquisitions on the I-Max Touch.
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1.3 Image acquisition on the I-Max Touch 3D
Volumetric (3D) acquisitions)
In 3D acquisitions a sequence of two-dimensional images is acquired during a rotation of the rotating arm.
In this type of acquisition, the X-ray generator is operated in pulsed mode, with short pulses emitted at each
degree of the rotating arm. The sequence of images thus obtained is passed to special software residing on
the dedicated computer, which uses sophisticated mathematical algorithms to generate the corresponding
volume.
The spatial resolution of the image obtained is the result of both the size of the sensor's pixels and the
quality of the reconstruction software; in this case the resolution is measured in "voxels" (short for VOlume
piXEL).
The volume thus reconstructed is returned to the image display software, in which different operations are
possible that allow the operator or the physician to select which part of the volume to display, to obtain
specific sections at a given point, etc.
Panoramic image acquisitions
Special functions of the flat panel also allow acquiring partial sensor images with a frame rate (acquisition
speed) higher than that used for 3D images.
In this mode, the X-ray emission is continuous, as in normal panoramic radiography. The sequence of
images obtained are the input for special reconstruction software, developed specifically for the I-Max Touch
3D, which allows the reconstruction of the standard panoramic X-ray simulating the physical mechanism of
"kinetic cancelation" as used in analogue systems.
1.4 Icons appearing in the manual
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.
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2. USABILITY
The I-Max Touch or I-Max Touch 3D medical system is intended to be used in radiology or dental practices.
In the first case the user is either the radiologist or the technician specialized in radiology, in the latter case it
is the dentist. The radiologist or the dentist is responsible for the assessment of the risk/benefit ratio. In both
cases, these are people who already have basic knowledge about:
Emission of ionizing radiation.
Danger of physical harm related to the excessive use of ionizing radiation.
Methods to reduce the risk of excessive radiation to the patient (use of lead-lined protections, etc.).
The operator must be familiar in the use of a personal computer and related programs, in order to use the
functions on the computer easily.
2.1 Training
The operator training follows at the end of the system's installation and concerns both the use of the system
and the image acquisition and display programs. The training does not require the use of special tools. The
user manual describes the steps necessary to perform standard panoramic and cephalometric type X-rays
and volumetric X-rays (or 3D).
2.2 Patient profile
The machine is suitable for all types of patients. Depending on the type of patient, the different execution
modes of each examination can be selected on the operating console (adult, child - small, medium or large
bone density - 3 types of dentition).
2.3 Prescription use statement (USA)
CAUTION: Federal law restricts this device to sale by or on the order of a dentist or
any other practitioner licensed by the law of the State in which he practices to use or order
the use of the device.
2.4 Indications for use
The I-Max Touch and I-Max Touch 3D panoramic X-ray imaging systems with cephalostat are extra-oral
source X-ray systems, intended for dental radiographic examinations of the teeth, the jaw and oral
structures. It is specifically suited for panoramic examinations, implantology, TMJ studies and cephalometry.
It has the capability, using the CBVT technique, to generate dento-maxillofacial 3D images. The 3D unit uses
a cone-shaped X-ray beam projected onto a flat panel detector to acquire the data; the examined volume
image is then reconstructed to be viewed on 3D imaging workstations. 2D Images are obtained using the
standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other
legally qualified healthcare professionals.
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3. SAFETY INFORMATION
WARNING: Please read this chapter thoroughly.
Owandy Radiology designs and builds its devices in compliance with the safety requirements; furthermore it
supplies all information necessary for the correct use and the warnings related to any danger associated with
X-ray generating units.
Owandy Radiology cannot be held responsible for:
The use of the I-Max Touch or I-Max Touch 3D in a different way 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 the user and service manuals supplied with the unit and by wrong operation
of the unit.
Mechanical and/or electrical modifications performed during and after the installation, different from
those described in the service manual.
Installation and any technical interventions must only be performed by qualified technicians authorized by
Owandy Radiology. Only authorized personnel can remove the covers and/or have access to the
components under tension.
In compliance with the IEC 60601-1 standard, the modification of the equipment or its parts is strictly
prohibited.
3.1 Applicable safety regulations
3.1.1 Standards
The I-Max Touch complies with the following standards:
General safety:
oIEC 60601-1:1988+A1:1991+A2:1995
oIEC 60601-1-4:1996+A1:1999
oIEC 60601-2-7:1998
oIEC 60601-2-28:1993
oIEC 60601-2-32:1994
Electromagnetic compatibility:
oIEC 60601-1-2:2001
Protection against radiation:
oIEC 60601-1-3:1994
oIEC 60825-1:1993+A1:1997+A2:2001
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The I-Max Touch 3D complies with the following standards:
General safety:
oIEC 60601-1:1988+A1:1991+A2:1995
oIEC 60601-1-1:2000
oIEC 60601-1-4:1996+A1:1999
oIEC 60601-2-7:1998
oIEC 60601-2-28:1993
oIEC 60601-2-32:1994
oIEC 60601-2-44:2001
Electromagnetic compatibility:
oIEC 60601-1-2:2001
Protection against radiation:
oIEC 60601-1-3:1994
oIEC 60825-1:1993+A1:1997+A2:2001
Usability:
oIEC 60601-1-6:2004
Canadian Medical Device Regulations
21 CFR Subchapter J (110-120V version only)
0051 - Ensures the compliance of the I-Max Touch/I-Max Touch 3D to the Medical Device Directive
93/42/EEC and amendments issued by the European Community.
3.1.2 Classifications
The I-Max Touch is an electro-medical X-ray device belonging to Class 1 and Type B as per the IEC 60601-
1 classification; it foreseen for continuous working at intermittent load.
According to the CE 93/42 directive for medical devices the equipment belongs to class II B.
According to the Canadian MDR the equipment belongs to class II.
According to FDA 21 CFR the equipment belongs to class II (110-120V version only).
The I-Max Touch 3D is a class I electro-medical device and Type B as per the IEC 60601-1 classification.
The classification according to EC Directive 93/42 and subsequent amendments for medical devices is Class
II b.
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3.2 Warnings
The I-Max Touch and I-Max Touch 3D units must be used in dental surgeries, radiology and hospital
surroundings.
The unit has been built to support a continuous operation at intermittent load; therefore please follow the use
cycles described in the manual to enable the device to cool down.
The unit must be switched off while using devices such as electrosurgical devices or similar apparatus.
This device has not been designed to be used in environments where vapors, anesthetic mixtures flammable
with air, or oxygen and nitrous oxide can be detected.
Do not let water or other liquids seep into the device as this could cause short-circuits and corrosion.
Wherever necessary use the appropriate accessories such as leaded aprons to protect the patient from
radiation.
While performing the image acquisition no-one apart from the operator and the patient must remain in the
room.
WARNING: Precautions to take when using the laser centring devices (Class I
according to EN60825-1):
It is necessary to have an adequate illumination in the room.
Do not look into the output windows of the laser centring units.
Do not stare at the reflections of the laser pointers.
Instruct the patient to keep his/her eyes closed as long as the laser pointers are
switched on.
Before starting an examination, the patient must remove earrings, glasses, necklaces
and anything else that could reflect the laser beam or affect the radiographic image.
Do not clean the openings of the laser centring devices with tools that could modify
the optics. Necessary cleaning must be performed only by authorised technicians.
Operations different than those indicated could cause dangerous non-ionising
radiations to be emitted.
WARNING: The USB port on the control panel MUST NOT be used with an external
harddisk; it must only be used only with USB memory sticks.
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The centering bite or the protective bite sleeve, the head strip for 3D examinations and the ear
centering devices of the cephalostat must be replaced after each examination in which they were
used.
Clean and disinfect all parts that come into contact with the patient.
Before cleaning the device please disconnect it from the line voltage. Pushing the ON/OFF button at the
base of the equipment must not switch on the unit.
Although the dose supplied by dental X-ray units is quite low and distributed on a small surface, the operator
must adopt the precautions and/or suitable protection for the patient and himself during the image
acquisition. 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 the unit near the patient stay as far as the remote control cable allows or at least
1.5 m (4.9 ft) (I-Max Touch) or 2m (6.6 ft) (I-Max Touch 3D) both from the X-ray source and from the patient
as shown in the imagesfigures below.
Minimum distance from X-ray source 1.5 m (4.9 ft) or 2 m (6.6 ft) Protected area
Figure 1 - Panoramic version
Minimum distance from X-ray source 1.5 m (4.9 ft) or 2 m (6.6 ft) Protected area
Figure 2 - Cephalometric version
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NOTE: The dimension of the "patient's environment" is defined as a distance of at
least 1.5 m (4.9 ft) (I-Max Touch) or at least 2 m (6.6 ft) (I-Max Touch 3D) from the actual
patient. If the computer is positioned inside the patient's environment it must conform to the
requirements specified by the IEC 60601-1 standard for medical devices; if located outside of
the patient's environment it must be compliant with the IEC 60950 standard.
NOTE: Do not apply movements to the rotating arm or the tube-head when the
equipment is on. Never try to rotate the rotating arm manually when the unit is switched on,
to avoid permanent damage to the unit. The manual movement is only allowed in case of
error 206 (no power to motors) to allow the patient to exit the unit.
WARNING: Precautions during installation and service interventions:
Please take the highest care while mounting the column to the wall and strictly follow the
instructions listed in this manual.
Before removing the covers of the column or before removing the covers of the generator
board (A10) disconnect the power supply to the device, both switching the main switch
and the magneto-thermal differential off, and wait for at least 2 minutes.
When the device is operated without the covers pay the highest attention since high
voltage is generated in the power supply unit and the voltage is at about 400 Vdc on the
generator board. This is indicated by green LED H1. Should the LED be OFF, and before
any other intervention, disconnect the device from the net, wait at least 2 minutes, then
check fuse F1 (10AF) on the supply unit or F2 (5AF) on the generator board (see circuit
diagrams).
Each intervention must be performed after having disconnected the device from the
power supply net and after LED H1 is OFF. It is always advisable to wait for at least 2
minutes after the LEDs have switched off.
The system structure does not allow the repair of faulty/damaged parts; these must be
replaced using original spare parts supplied by Owandy Radiology. Only trained
personnel are authorized to make service interventions on the unit, following the
instructions contained in this manual.
WARNING: The network connector on the base of the I-Max Touch 3D column must
be connected through a shielded Ethernet cable "Cat.5e" or greater to the dedicated
computer for image acquisition and 3D and panoramic reconstruction. Do not use this
connector to connect the I-Max Touch 3D to existing LAN networks. The Ethernet cable of an
I-Max Touch (2D) unit however can be connected to an existing network.
SERVICE MANUAL
I-Max Touch / I-Max Touch 3D – Ver. 4 Page: 16
3.2.1 Distribution of stray radiation (I-Max Touch 3D only)
-1.5 -1 -0.5 0 0.5 1 1.5m
1.5m 0.02 0.02 0.03 0.03 0.03 0.03 0.02 1.5m
1 0.025 0.03 1
0.5 0.03 0.08 0.065 0.02 0.5
0 0.03 C 0.004 0
-0.5 0.03 0.09 0.08 0.01 -0.5
-1 0.03 0.02 -1
-1.5 0.02 0.03 0.03 0.04 0.03 0.025 0.02 -1.5
-1.5 -1 -0.5 0 0.5 1 1.5m
This figure illustrates the distribution of stray radiation in the horizontal plane at the centre of rotation of the
scanning unit in the area of a 3 x 3 m rectangle. The measurement was performed using a cylindrical
phantom with a diameter of 320 mm and a length of 140 mm placed in the centre of rotation of the scanning
unit, using the "3D Dentition" examination mode and these parameters: 86 kV - 10 mA - 8 s. The distribution
values in the table are expressed as air Kerma for mAs (µGy/mAs).
3.2.2 Electromagnetic emissions
In accordance with the IEC 60601-1-2 standard, the I-Max Touch/I-Max Touch 3D is suitable for use in a
specified electromagnetic environment. The purchaser or user of the system should assure that it is used in
an electromagnetic environment as described below.
Emissions test Compliance Electromagnetic environment
Radiated and
conducted RF
emissions
CISPR 11
Group I The I-Max Touch/I-Max Touch 3D uses R.F. energy only for its
internal function. Therefore, the R.F. emissions are very low and
not likely to cause any interference in nearby electronic
equipment.
Class B The I-Max Touch is suitable for use in domestic establishments
and in establishments directly connected to the low voltage
power supply network which supplies buildings used for
domestic purposes.
Class B+12 The I-Max Touch 3D is suitable for use in domestic
establishments and in establishments directly connected to the
low voltage power supply network which supplies buildings used
for domestic purposes.
Harmonics emissions
IEC 61000-3-2
Complies The I-Max Touch is suitable for use in establishments directly
connected to a public low voltage power supply network.
Class A The I-Max Touch 3D is suitable for use in establishments directly
connected to a public low voltage power supply network.
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies The I-Max Touch/I-Max Touch 3D is suitable for use in
establishments directly connected to a public low voltage power
supply network.
SERVICE MANUAL
I-Max Touch / I-Max Touch 3D – Ver. 4 Page: 17
3.2.3 Electromagnetic immunity
In accordance with the IEC 60601-1-2 standard, the I-Max Touch/I-Max Touch 3D is suitable for use in a
specified electromagnetic environment. The purchaser or user of the system should assure that it is used in
an electromagnetic environment as described below.
Immunity test IEC 60601-1-2
test level
Compliance
level
Electromagnetic
environment
Electrostatic discharges (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
Test level
IEC 60601-1-2
Residential / Hospital
Electrical fast transient / burst
IEC 61000-4-4
2 kV for power supply lines
1 kV for input/output lines > 3 m
Test level
IEC 60601-1-2
Residential / Hospital
Surge
IEC 61000-4-5
1 kV differential mode
2 kV common mode
Test level
IEC 60601-1-2
Residential / Hospital
Voltage dips, short inter-
ruptions and voltage variations
on power supply input lines
IEC 61000-4-11
0 % Un for 0.5 cycles
40 % Un for 5 cycles
70 % Un for 25 cycles
0 % Un for 5 s
Test level
IEC 60601-1-2
Residential / Hospital
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m Test level
IEC 60601-1-2
Residential / Hospital
Additionaly for the I-Max Touch only:
Immunity test IEC 60601-1-2
test level
Compliance
level
Electromagnetic
environment
Radiated RF
IEC 61000-4-3
Non-life-supporting equipment
3 V/m
80 MHz to 2.5 GHz
Test level
IEC 60601-1-2
Residential / Hospital
Life-supporting equipment
10 V/m
80 MHz to 2.5 GHz
Test level
IEC 60601-1-2
Residential / Hospital
Conducted RF
IEC 61000-4-6
Non-life-supporting equipment
3 V
150 kHz to 80 MHz
Test level
IEC 60601-1-2
Residential / Hospital
Life-supporting equipment
3 V outside ISM band
10 V inside ISM band
Test level
IEC 60601-1-2
Residential / Hospital
SERVICE MANUAL
I-Max Touch / I-Max Touch 3D – Ver. 4 Page: 18
Additionaly for the I-Max Touch 3D only:
Immunity test IEC 60601-1-2 test
level
Compliance
level
Electromagnetic environment
Portable and mobile RF communications
equipment should be used no closer to any part
of the I-Max Touch 3D, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
Test level
IEC 60601-
1-2
d = 1.2 x √P 80 MHz to 800 MHz
d = 2.3 x √P 800 MHz to 2.5 GHz
Conducted RF
IEC 61000-4-6
3 V
50 kHz to 80 MHz
Test level
IEC 60601-
1-2
d = 1.2 x √P
Where "P" is the maximum output rating of the
transmitter in watts (W) according to the
transmitter manufacturer and "d" is the
recommended separation distance in meters (m).
Field strength for fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
: iInterference may occur in the vicinity
of the equipment marked with this symbol.
3.2.4 Recommended separation distances for non-life supporting
equipment
3.2.4.1 I-Max Touch
The I-Max Touch is intended for use in an electromagnetic environment in which the radiated RF
disturbances are controlled. The customer or the user of the system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the I-Max Touch as recommended below, according to the maximum output
power of the communications equipment.
RF source Typical rated power (W) Distance (m/ft)
Microcellular phone CT1, CT2, CT3 0.01 0.4
DECT cellular phone, wireless information
technology equipment (modems, LANs)
0.25 2
Cellular phone, hand held (USA) 0.6 3
Cellular phone, hand held (e.g. GSM and NMT,
Europe; DECS 1800)
2
8
6
11
Walkie-talkie (rescue, police, fire, maintenance) 5 9
Cellular phone, bag 16 16
Mobile radio (rescue, police, fire) 100 40
SERVICE MANUAL
I-Max Touch / I-Max Touch 3D – Ver. 4 Page: 19
For transmitters using frequencies below 800 MHz, the distance can be estimated using equation A: d = 4
P
For transmitters using frequencies between 800 MHz and 2.5 GHz, the distance can be estimated using
equation B: d = 2.3 P
where P is the rated power of the transmitter in watt (W) according to the transmitter manufacturer.
3.2.4.2 I-Max Touch 3D
The I-Max Touch 3D is intended for use in an electromagnetic environment in which the radiated RF
disturbances are controlled. The customer or the user of the system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the I-Max Touch 3D as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum
output power of
the transmitter (W)
Separation distance according to
frequency of transmitter (m)
150kHz to 80MHz
d = 1.2 x √P
80MHz to 800MHz
d = 1.2 x √P
800MHz to 2.5GHz
d = 2.3 x √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at the maximum output power not listed above, the recommended separation distance
"d" in meters (m) can be estimated using the equation applicable to the frequency of the transmitter where
"P" is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE: At 80 MHz and 800 MHz the separation distance for the higher frequency range
applies.
NOTE: These guidelines may not apply to all situations. Electromagnetic propagation
is affected by absorption and reflection of structures, objects and people.
SERVICE MANUAL
I-Max Touch / I-Max Touch 3D – Ver. 4 Page: 20
3.3 Environmental risks and disposal
In some of its parts the device contains materials and liquids that, at the end of the lifespan of the unit, must
be disposed of at the appropriate disposal centers. The device contains the following materials and/or
components in particular:
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.
Applied parts: non-biodegradable plastics, iron and aluminium.
Digital sensor: iron, lead, copper, integrated electronic components.
INFORMATION TO USERS IN THE EUROPEAN COMMUNITY: According to art. 13 of
the Legislative Decree of July 25th, 2005, nr. 151 "Implementation of Directives 2002/95/CE,
2002/96/CE, and 2003/108/CE, regulating the reduction of the use of hazardous substances in
electrical and electronic equipment, as well as the waste disposal"
The symbol with the waste bin crossed on the equipment or its packaging, indicates that the
product must be separately collected from other waste at the end of its life.
The separate collection of the present equipment that has reached the end of its life is
organized and managed by the manufacturer. The user who wishes to dispose of this
equipment must contact the manufacturer and follow their system to enable the separate
collection of the equipment at the end of its life.
Suitable separate waste collection for the subsequent start of the equipment discarded for
recycling, for treatment and for environmentally friendly disposal, contributes in preventing
possible adverse effects on the environment and health and promotes the reuse and/or
recycling of materials of which the equipment is comprised.
Illegal disposal of the product by the holder implies the application of administrative
sanctions provided by law
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