Owandy I-Max Touch User manual

Version 25 September 2009 (Rev. 0)
I-Max Touch 0459
(110-120V version)
User's Manual

USER'S MANUAL
Contents
(Rev. 0) I-Max Touch (110-120V)
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

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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

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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.

USER'S MANUAL
Contents
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USER'S MANUAL
Introduction
(Rev. 0) I-Max Touch (110-120V)
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.
*

USER'S MANUAL
Introduction
I-Max Touch (110-120V) (Rev. 0)
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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.
*

USER'S MANUAL
Safety information
(Rev. 0) I-Max Touch (110-120V)
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.

USER'S MANUAL
Safety information
I-Max Touch (110-120V) (Rev. 0)
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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.

USER'S MANUAL
Safety information
(Rev. 0) I-Max Touch (110-120V)
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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