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

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

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

USER'S MANUAL
Contents
I-Max Touch (110-120V) (Rev. 0)
iv
THIS PAGE IS INTENTIONALLY LEFT BLANK

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)
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.
*

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)
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.

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

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

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

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

USER'S MANUAL
Cleaning and disinfection
(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.

USER'S MANUAL
Description
I-Max Touch (110-120V) (Rev. 0)
10
4. DESCRIPTION
4.1 Identification labels and laser labels
4
3
6, 7
1, 8
2
5

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

USER'S MANUAL
Description
I-Max Touch (110-120V) (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.

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

USER'S MANUAL
Technical characteristics
I-Max Touch (110-120V) (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 kVpsteps
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

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