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STRATO 2000 0434

(120V version)

User's Manual
Release 28 April 2003 (Rev. 0)
USER'S MANUAL
Contents

Contents
1. INTRODUCTION 1
1.1 Icons appearing in the manual ...............................................................3

2. SAFETY INFORMATION 4
2.1 Warnings ...............................................................................................5
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 Function, Models and Versions ............................................................ 12
4.2.1 Film / Screen combinations................................................................ 14
4.2.2 Basic version ...................................................................................... 15
4.2.3 Version with cephalometric device ...................................................... 15
4.2.4 Optional functions .............................................................................. 16
4.3 Parts location....................................................................................... 17

5. TECHNICAL SPECIFICATIONS 19
Environmental features ...................................................................... 23
5.1 Dimensions.......................................................................................... 24
5.2 Loading curve of the tube and cooling curve of the anode ..................... 26
5.3 Applied safety regulations .................................................................... 28
5.4 Note on the “Constant magnification” for Panoramic and TMJ
(close/open mouth) exposures.............................................................. 29
5.5 Measurement method of technical factors
(Paragraph for the authorized personnel).............................................. 30
5.6 Verify method of exposure parameters
(Paragraph for the authorized personnel).............................................. 31

6. GENERAL INSTRUCTIONS FOR USE 35


6.1 Control panel - Descriptions and functions .......................................... 35
6.1.1 Key function description ..................................................................... 38
6.2 “Switching ON” the device .................................................................... 39
6.3 Positioning of chin support .................................................................. 41
6.4 Panoramic examination........................................................................ 42
6.4.1 Getting started ................................................................................... 42
6.4.2 Anatomic / Manual exposure.............................................................. 44
6.4.2.1 Anatomic exposure................................................................ 45
6.4.2.2 Manual exposure................................................................... 46
6.4.3 How to prepare the patient ................................................................. 48
6.4.4 Making an exposure ........................................................................... 50

(Rev. 0) i STRATO 2000 (120V)


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Contents

6.5 TMJ examination ................................................................................. 55


6.5.1 Getting started ................................................................................... 57
6.5.2 Anatomic / Manual exposure ............................................................. 58
6.5.2.1 Anatomic exposure................................................................ 59
6.5.2.2 Manual exposure .................................................................. 60
6.5.3 TMJ closed mouth .............................................................................. 61
6.5.3.1 Preparing the patient............................................................. 62
6.5.3.2 First exposure (Closed mouth)............................................... 64
6.5.4 TMJ open mouth ................................................................................ 66
6.5.4.1 Preparing the patient............................................................. 67
6.5.4.2 Second exposure (Open mouth) ............................................. 69
6.6 Biaxial temporomandibular joint examination ...................................... 72
6.6.1 Getting started ................................................................................... 74
6.6.2 Anatomic / Manual exposure ............................................................. 75
6.6.2.1 Anatomic exposure................................................................ 76
6.6.2.2 Manual exposure .................................................................. 77
6.6.3 How to prepare the patient ................................................................. 78
6.6.4 Making an exposure ........................................................................... 80
6.7 Sinus examination ............................................................................... 84
6.7.1.1 Preparing the patient............................................................. 86
6.7.2 Making an exposure ........................................................................... 88
6.8 IMPLANT examination.......................................................................... 92
6.8.1 Linear tomography programs.............................................................. 94
6.8.1.1 Examination preparation....................................................... 96
6.8.1.2 Anatomical parameters ......................................................... 97
6.8.1.3 Tomographic parameters..................................................... 100
6.8.1.4 Radiographic results ........................................................... 101
6.8.1.5 Right side tomography (quadrants 1 and 4) ......................... 102
6.8.1.6 Left side tomography (quadrants 2 and 3) ........................... 103
6.8.2 Positioning of the implant Bite Lock.................................................. 104
6.8.2.1 Bite block preparing: Maxilla Implant.................................. 105
6.8.2.2 Bite block preparing: Mandible Implant............................... 106
6.8.3 Equipment preparation..................................................................... 107
6.8.4 Manual / Anatomic exposure ........................................................... 108
6.8.4.1 Anatomic exposure.............................................................. 108
6.8.4.2 Manual exposure ................................................................ 109
6.8.5 Selection of anatomic and tomographic parameters .......................... 110
6.8.6 How to prepare the patient ............................................................... 112
6.8.7 Making an exposure ......................................................................... 115
6.9 Cephalometric examination................................................................ 120
6.9.1 Getting started ................................................................................. 122
6.9.2 Anatomic / Manual exposure ........................................................... 125
6.9.2.1 Anatomic exposure.............................................................. 126
6.9.2.2 Manual exposure ................................................................ 127

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6.9.3 How to prepare the patient ............................................................... 128


6.9.4 Making an exposure ......................................................................... 130
6.10 Messages on display .......................................................................... 133
6.11 Research and correction of possible defects in dental radiographies.... 137
6.11.1 Faults due to a wrong positioning of the patient ............................... 137
6.11.2 Defects due to wrong data setting and to the dark room ................... 138
6.11.3 Defects on film due to the device....................................................... 138
6.12 Analysis of the problems on the panoramic examinations ................... 139
6.12.1 Proper positioning of the patient ....................................................... 140
6.12.1.1 Error due to a bad patient's positioning............................... 142
6.12.1.2 Images with artefacts .......................................................... 150
6.12.1.3 Incorrect film contrast and density ...................................... 154
6.13 Storing of automatical exposure parameters....................................... 156
6.13.1 Exposure parameter ......................................................................... 156
6.13.2 Soft tissue filter ................................................................................ 157
6.13.3 Storing parameters ........................................................................... 157
6.13.4 Table of pre-set anatomic parameters ............................................... 158

7. MAINTENANCE 159

This publication can only be reproduced, transmitted, transcribed or translated into


any human or computer language with the written consent of VILLA SISTEMI
MEDICALI S.p.a.
This Manual in English is the original version.

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Contents

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STRATO 2000 (120V) iv (Rev. 0)


USER'S MANUAL
Introduction

1. INTRODUCTION

NOTE:
The present manual is updated for the product it is sold with in order to
grant an adequate reference to use properly and safely the product.
The manual may not reflect changes to the product not impacting
operating modes or safety.

STRATO 2000, produced by VILLA SISTEMI MEDICALI, is a X-ray device


for the radiographic analyses of the maxillo-facial complex.
The basic version of the STRATO 2000 performs panoramic examination
of the maxillo facial complex or on half of it allowing the choice left or
right. Dedicated options are available to perform additional tests
concerning the same maxillo facial complex, temporo mandibular joint
(TMJ) cephalometric examination and tomographic examination of the
dental arch particularly useful in implantation procedures.

STRATO 2000 is equipped for the use of advanced functions, than can be
accessed by connection the device to a common PC (not supplied by Villa
Sistemi Medicali).
Specifically by the connection to a common PC it is possible to make use
of the following functions:
U.C.A. (User Customizable Applications) platform
i.e. applications customized by the user. By this function you can
expand by yourself the performance of your STRATO 2000.
You can ask to the local sale organization new specific examinations
for different applications:
• IMPLANT: Linear tomography for implantation procedure
• TMJ: Specific examinations for temporo-mandibular joint
• SINUS: Examination of nasal sinus
• A.D.A.: Advanced Dental Applications including the improved
orthogonal projection, frontal dentition and the
reduced dose panoramic examination.
The new examinations software packages will be delivered on CD and
you will be able to install them in a few minutes.

(Rev. 0) 1 STRATO 2000 (120V)


USER'S MANUAL
Introduction

DMS Software
The DMS (Data Management System) allows the complete
management of the patient archive and of performed examinations,
storing an historical archive of the radiological parameters for each
examination.
The DMS software operates through a serial connection (RS232)
between STRATO 2000 and a PC.
The DMS makes possible the following functions:
• Archive personal data of patients (with the possibility to manage
different archives, for example one for each doctor operating in
the same facility)
• Archive of all examination with the relevant radiological
parameters
• Remake of an examination with the same parameters used time
before
• "Virtual keypad" allowing to select the radiological parameters
from the PC
• Print out of the archive
• Print out of labels with patient data and examination type for film
identification
• Import / Export of archived data
• Update of UCA examination software
• Consulting of on line documentation.
The DMS software is included in each UCA software package.

NOTE:
The DMS software is not an "image acquisition" software.

NOTE:
A detailed description of the function of the DMS software is given in the
specific User's Manual for DMS / U.C.A. software.

The aim of this publication is to instruct the user on the safe and
effective use of the device.
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 using the machine; it
is advisable to keep the manual near the device to refer to it while
operating.
STRATO 2000 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.

STRATO 2000 (120V) 2 (Rev. 0)


USER'S MANUAL
Introduction

1.1 Icons appearing in the manual


This icon indicates a NOTE: please read thoroughly the items marked
by this picture.

This icon indicates a WARNING: the items marked by this icon refer to
the safety aspects of the patient and/or of the operator.

(Rev. 0) 3 STRATO 2000 (120V)


USER'S MANUAL
Safety information

2. SAFETY INFORMATION

WARNING:
Please read this chapter thoroughly.

VILLA SISTEMI MEDICALI designs and builds its devices complying with
the related safety requirements; furthermore it supplies all information
necessary for a correct use and the warnings related to danger associated
with X-rays generating units.

Villa Sistemi Medicali, has not to be held responsible for:

• use of STRATO 2000 different than the intended use,


• damages to the unit, to the operator, to the patient, caused both by
installation and maintenance procedures different than 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 than those described in the service
manual.

Installation and any technical intervention must only be performed


by qualified technicians authorised by Villa Sistemi Medicali.

Only the authorised personnel can remove the covers and/or have
access to the components under tension.

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Safety information

2.1 Warnings
This device has not been designed to be used in environments where
vapours, anaestethic mixes flammable with air, or oxygen and nitrous
oxide can be detected.

Avoid pouring water, even accidentally, or other liquids into the device,
as this could cause short-circuits.

Before cleaning the device, please disconnect it from the line voltage.

Wherever necessary, use the fit accessories, such as the leaded aprons,
to protect the patient from radiations.

While performing the radiography, no one, apart from the operator and
the patient, must remain in the room.

STRATO 2000 has been built to support a continuous operation at


intermittent load; therefore please follow the described use cycles to
enable the device cooling down.

Though this unit has been designed with a quite acceptable protection
level from electromagnetic interferences, 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 amatoeurial use. Cellular telephones are only
admitted at a distance of more than 1,5 mt 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 the Electromagnetic
Compatibility rules in force. Non-complying instruments, of which the
poor immunity from electromagnetic fields is well known, must be
installed at least 3 mt far from the STRATO 2000 and supplied by a
different electrical line.

STRATO 2000 must be off while using devices such as electrical lancets
or the like.

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.

After use, please replace the bite and the ear-centring devices.

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USER'S MANUAL
Safety information

Though the X-ray quantity supplied by dental X-ray units is quite low
and distributed on a small surface, the operator must adopt the
precautions and/or fit protections 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 cable of the remote control
allows it, or at least 1,5 mt far both from the X-ray source and from the
patient, as shown in the Figure 1 and Figure 2.

Figure 1 - Panoramic version

Figure 2 - Cephalometric version

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Safety information

WARNING: PRECAUTIONS WHILE USING LASER CENTRING


DEVICE:
• Keep always a fit illumination in the room.
• Do not look into the output windows of laser centering 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. Necessary cleaning must be performed only
by authorised technicians.
Operations different than those indicated could cause the ejection of
dangerous non-ionising radiations.

NOTE:
When the unit is on, do not move manually the rotating arm or the
tube-head (part 2a of Figure 3).

2.2 Environmental risks and displacement


The device contains in some of its parts, materials and liquids that at the
end of the units life, must be disposed of at the fit disposal centres.

Particularly the device contains the following materials and/or


components:
• Tube-head: dielectric oil, lead, copper, iron, aluminium, glass,
tungsten, beryllium.
• Control panel and Remote control: 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.

NOTE:
VILLA SISTEMI MEDICALI is not responsible for the displacement of the
device performed by the user and for the related costs.

(Rev. 0) 7 STRATO 2000 (120V)


USER'S MANUAL
Safety information

2.3 Symbols used


In this manual and on the STRATO 2000 itself, apart from the symbols
indicated on the control panel, also the following icons are used:

Symbol Description

Device with type B applied parts

∼ A.C.

N Connection point to the neutral conductor

L Connection point to the line conductor

Protection grounding

Operation grounding

OFF ; device not connected to the mains

ON ; device connected to the mains

Laser

Laser source output

Dangerous voltage

Activation of cephalometry ear-set rods

Conformity to the CE 93/42 Directive


0434

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Safety information

3. CLEANING AND DISINFECTION


In order to get an accurate hygene and cleaning it is necessary to follow
thoroughly all indicated procedures.

WARNING:
Disconnect the unit from the net
before performing any cleaning.

Do not let water or liquids enter the unit, these could cause corrosion or
short-circuits.

Use only a wet cloth and a mild


detergent to clean the painted
surfaces, the accessories and the
connection cables, and wipe then
with a dry cloth; do not use
solvents (alcohol, benzine, trichloro-
ethylene) nor corrosive and abrasive
solutions.

To clean the rare earths scintillating screens in the cassette, please follow
the indication given by the manufacturer, do not use detergents, solvent
(alcohol, benzine), corrosive or abrasive stuffs.

The bite-holding rod, the centring bite and the ear centring units of
the cephalostatus must be replaced after each examination.

Clean thoroughly the chin rest, the handles, the nose-rest and the
temple-support any time these are used.

It is advisable to disinfect, whenever necessary, the chin-rest, the


handles, the nose-rest and the temple support with a 2% Glutaraldehyde
solution or similar (find out what is available; e.g. Milton).

(Rev. 0) 9 STRATO 2000 (120V)


USER'S MANUAL
Description

4. DESCRIPTION

4.1 Identification labels and laser labels

7
4, 5, 6

1, 2, 3

10, 11

STRATO 2000 (120V) 10 (Rev. 0)


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Description

1b
ETL certification label
1a
STRATO 2000
identification label

2
Tube-head 3
identification label IMPLANT device
identification label

4
TMJ device
identification label

5 6
SINUS device A.D.A. device
identification label identification label

7
CEPHALOMETRIC
device
identification label

10
8 (N° 2) Spot laser
Warning label identification label

9
Laser warning
11
label
(N° 2) Laser symbol
label

(Rev. 0) 11 STRATO 2000 (120V)


USER'S MANUAL
Description

4.2 Function, Models and Versions

NOTE:
This STRATO 2000 model is designed to be upgraded with the
implementation of new functions and new examination now under
development in VILLA SISTEMI MEDICALI laboratories.
The device has been designed to follow technological and clinical
evolution of RX examination of the maxillo-facial complex.

STRATO 2000, produced by VILLA SISTEMI MEDICALI is a complete


ortopantomoghraphic device, which enables to perform all radiographies
commonly necessary in dental field.
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 cassettes used for all examinations are flat.


For cephalometry the following cassette sizes, to be selected in the order,
are available inches (8"x10"), 18x24 cm and 24x30 cm.
For all other examinations, the size is unique: 15x30 cm.

The basic version performs Panoramic and Emi-panoramic examination.


Available options, that can be enabled using the U.C.A. (User's
Customizable Applications) function, allow the system to perform further
examination:
• A.D.A. (Advanced Dental Applications)
Improved orthogonality Panoramic examination.
• Implant
This allows for the conduction of linear tomography examination of
dental arch, useful for Implant.
• Sinus
This option is used to perform radiographs of the sinises.
• TMJ
This option allows for Temporo Mandibular Joint examination in
closed / open way and biaxial TMJ.

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Description

NOTE:
The U.C.A. function allows customer to enable the option using special
codes that must be inserted into the software using a Personal Computer
(not supplied by Villa Sistemi Medicali).
Procedure on how enabled this options is described into the STRATO
2000 DMS Manual; please refer to this Manual for information on how to
proceed.

• Cephalometric device
This option is not a U.C.A. because to be enabled it needs the
installation of the CEPH arm.

(Rev. 0) 13 STRATO 2000 (120V)


USER'S MANUAL
Description

4.2.1 Film / Screen combinations

To get a good image quality, it is advisable to match the intensifying


screens and the films, as indicated hereafter:

Supplier Films Sensibility Screen

KONIKA MG Verde KR II
KONIKA MGH Verde KR II
KODAK T-MAT G/RA Verde Lanex Regular
AGFA HTA Verde Medium
FUJI HR-G Verde G8
IMATION XDA Verde T 16
KODAK T-MAT G/RA Verde Lanex Medium
STERLING ULTRAVISION Blu Ultravision Rapid

Table 1

NOTE:
It is advisable to use always films and screens of the same brand.
Combinations of films and screen of different manufacturer are possible
so long as the same sensitivity is maintained. Never combine films and
screens with different sensibility (green and blue).

The factory set values of the exposure factors listed in paragraph 6.13.4
as default, are indicative and optimised for the combination film/screen
supplied with the device (film T-MAT G/RA and screens Lanex Regular or
film KONIKA MG and KONIKA screens). For the other combinations listed
in the table or for further combinations, the exposure factors have to be
modified accordingly by acting as described in paragraph 6.13.
The real adjustment of these values depends on different conditions such
as the preference of the user for much or less exposed images.
The quality of the image, therefore, does not exclusively depend on
STRATO 2000 but it is also extremely important to pay attention to the
processing procedure of the films and the materials related

NOTE:
Perform the maintenance of the film processor as described in the related
instruction manual.
Regularly check the levels of the used chemical substances; replace them
regularly as indicated by the manufacturer (or according to the number
of processed films).

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Description

4.2.2 Basic version

The basic version enables to perform Panoramic – Adult and Child –


examinations with 3 sizes and 3 dental arch types for a total of 18
combinations in Automatic selection; in manual selection it is possible to
select high voltage between 50 kV and 80 kV, in 2 kV steps and anodic
current from 4 mA to 10 mA in 1 mA steps.
This function support also the half panoramic for right or left dental
arch. All examination are carried out with a “constant magnification”
factor of 1.23.

4.2.3 Version with cephalometric device

The version with cephalometric device enables to perform the following


examinations:
• Panoramic with the same characteristics described for the basic
version.
• Cephalometry for Adult and Children with 3 Sizes for up to 6
combinations in automatic selection. The manual mode enables to
change the voltage from 60kV to 80kV in 2kV steps, and the anode
current from 4mA to 12mA in 1mA steps. The examinations are
performed on cassettes which size is 8"x10", 18x24 cm or 24x30 cm.
The positioning of collimators occurs automatically according to the
used cassette and to the chosen projection; the Soft Tissues Filter
(STF) is motorised and can be adjusted to get the best projection of
the face profile.

(Rev. 0) 15 STRATO 2000 (120V)


USER'S MANUAL
Description

4.2.4 Optional functions

The device is designed to add the following optional functions:


• A.D.A. (Advanced Dental Applications)
Allowing to perform improved orthogonality Panoramic examination,
reducing the overlapping of teeth in order to improve diagnosis of
interproximal caries.
• Implant
Allowing examinations for implantology in Adults with 3 sizes, with a
total of 3 combinations in automatic selection; in Manual selection,
high voltage can be varied between 50kV and 80kV in steps of 2kV
and anodic current between 4mA and 10mA in 1mA steps.
The examination makes use of flat cassette having dimensions
15x30 cm. Collimator position is automatic.
• Sinus
Allowing to get images of the paranasal sinusis in frontal (front/back)
or lateral projection for right or left side.
• TMJ
Allowing the following examinations:
– TMJ closed/open mouth in lateral projection
– TMJ in biaxial projection.

NOTE:
All these examination can be added directly by the user, by the U.C.A.
(User Customizable Application) function. The additional function can be
added on STRATO 2000 units in field or on upgradable models of
STRATO X units.

NOTE:
The code inserted into STRATO 2000 to enable the optional examinations
is protected by an Unique Identification Code (UIC); in case the UIC is not
present or is faulty, an error E601 will be shown.

The Enter key "23" pressure will reset this condition, but at the

end of the start-up procedure only standard Panoramic examinations will


be enabled.

The UIC can be visualized on the system console by pressing at the same

time the Column up "27" and Column down "29" arrows.

The UIC is simple an identifier of the single STRATO 2000 unit; in order
to enable optional functions it is necessary to ask at Villa Sistemi
Medicali the enabling codes which are derived from the UIC.

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Description

4.3 Parts location


2

30
2a

1
1a

Figure 3

1- Column with base equipped with electrical power part and cursor
with motorised vertical movement. The column must be fixed at the
wall by 4 dowels, two fixing the upper part and two fixing the lower.
The front part of the column is equipped with an housing closed by
two covers, within which it is possible to set 4 trays (1a) containing
the consumables (bites, rods, etc.) and options (supports, etc.).

2- X, Y axes movement unit and rotation support, (CPU board) with


rotating arm equipped with: HF tubehead with power supply board
(2a), automatic primary collimator, soft tissues filter (STF) and laser
centring devices.

(Rev. 0) 17 STRATO 2000 (120V)


USER'S MANUAL
Description

3- Cassettes holder for all functions (apart from cephalometry) with flat
standard cassette 15x30 cm.

4- Chin support arm equipped with: control keyboard, temple support,


chin-rest, centring bite and handles. The control panel is equipped
with a soft-key keyboard, indication LED for the selected functions
and an alphanumeric two-row display for all technical, operative
and warning messages.

5- Cephalometric arm (optional) including cephalometric device,


cassette support (with laser alignment pointer directly from the
rotating arm) positioned on the left of the column.

30 - X-ray push button equipped with extendible cable, which allows the
user to operate the unit from proper distance as required by the
safety rules.

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Technical specifications

5. TECHNICAL SPECIFICATIONS
General features
Type STRATO 2000
Manufacturer VILLA SISTEMI MEDICALI
Buccinasco (MI) Italia
Class Class II according to 21CFR-
subchapter J.
Class II B for European Directive
for Medical Devices 93/42.
Class I with type B applied parts
according to IEC 601-1
Protection degree IP20
Rated line voltage 120 V∼ ±10%
Line frequency 60 Hz
Maximum line current 15 A (at 108V, 80kV, 12mA – see Note 1)
Power consumption 2 kVA
Protection fuse (F2) 15 A F
Transformer protection fuse T1 (F1) 0.8 A T
Controls supply protection fuse (F5) 0.5 A T
Column motor protection fuse (F3, F4) 7AT
Line voltage regulation < 3% at 108 V∼ (see Note 1)
Rated output voltage (kVp) 50 ÷ 80 kVp in 2 kVp steps
Anodic current 4 ÷ 10 mA in 1 mA steps for PAN/TMJ
4 ÷ 12 mA in 1 mA steps for Ceph

NOTE 1:
Due to the technology used to compensate line voltage fluctuations, the
max line current drawn from the line is at lowest voltage (108 V).

(Rev. 0) 19 STRATO 2000 (120V)


USER'S MANUAL
Technical specifications

Exposure time
Panoramic (PAN) 15 s PAN Adult / 13.5 s PAN Child
Emi Panoramic 8 s Adult / 8 s Child
TMJ open/closed mouth 5.3 s per image for left and right joint in
open and closed condition (11 s total
time)
TMJ biaxial 10.8 s (total time)
Implant 3.4 s (minimum) - 11.4 s (maximum) for
4 images
Sinus P/A projection 10.5 s
Sinus lateral projection 5.2 s each side
Cephalometry (Ceph) 0.2 ÷ 3 s
Exposure time accuracy ± 10 %
Examination programs
Examination selection • Automatic selection for Adult and
Child, 3 sizes, 3 arches (in Panoramic
and TMJ)
• Automatic selection for Adult and
Child, 3 sizes (in biaxial TMJ)
• Automatic selection for Adult, 3 sizes,
3 arches (in Implant)
• Manual selection
• Collimator with automatic positioning
Panoramic • Standard Panoramic
• Emi Panoramic
TMJ (Temporal Mandibular Joint) • TMJ open and closed mouth
• TMJ biaxial
Implant • 2 slices (one longitudinal and one
transversal)
• 4 slices (one longitudinal and three
transversal)
Cephalometry • Cassette 8" x 10"
• Cassette 18 x 24 cm
• Cassette 30 x 24 cm (24 x 30 cm
optional; in this case the size 24 x 18
symmetric is not available).
• Soft Tissues filter adjustable by
motorized movement.

STRATO 2000 (120V) 20 (Rev. 0)


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Technical specifications

Image magnification
PAN and TMJ open/closed mouth, 1 : 1.23 (constant)
Sinus P/A or L/L
TMJ biaxial 1.20 (overage)
Implant 1 . 1.37 (constant)
Ceph 1 : 1.1 (overage)
No. of images in TMJ (open/closed 4
mouth and biaxial)
Tubehead characteristics
Model MS 05
Manufacturer Villa Sistemi Medicali S.p.A.
20090 Buccinasco (MI) Italia
Maximum tube voltage 80 kVp
kVp accuracy ±8%
Max. anodic current 12 mA
Anodic current accuracy ± 10 %
Duty cycle 1 : 16
Nominal power 0.96 kW (80 kVp - 12 mA)
Total filtration 2.5 mm Al eq. @ 70 kVp
HVL (Half value layer) >2.5 mm Al eq. @ 80 kVp
Transformer insulation Oil bath
Cooling By convection
Leakage radiation at 1 m < 0.5 mGy/h @ 80 kVp - 12 mA - 3 s duty
cycle 1/16
Reference time product current 1.2 mAs (6mA for 200msec)

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Technical specifications

X-ray tube characteristics


Manufacturer CEI Bologna (Italia)
Type OPX 105
Nominal focus size 0.5 IEC 336
Inherent filtration 0.5 mm Al eq.
Anode tilt 5°
Anode material Tungsten
Nominal maximum voltage 105 kVp
Filament max current 4A
Filament max voltage 8V
Anode thermal capacity 30 kJ
Laser centering devices
3 laser beams are used for the patient positioning; beams align mid Sagittal,
Frankfurt and Canine Planes (please refer to relevant paragraphs for detailed
explanation).
Wave length 635 nm
Optical power of laser diode 5 mW
Optical power of the collimed beam 4.5 nW
Divergence 6.67 mRad
Optical power on the working surface < 3 mW
Laser class 3A
DNRO in 30 s application period 0.05 m

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Technical specifications

Mechanical characteristics
Focus-film distance (PAN, TMJ and 51 cm (20")
Implant)
Film size (PAN, TMJ and Implant) 15 x 30 cm flat cassette
Focus film distance (CEPH) 165 cm (65")
Film size (CEPH) 8" x 10", 18 x 24 cm and 24 x 30 cm
Telescopic motorized column run 67 cm (26.4")
Total height max. 232 cm (91.3")
Width x Length • 100 x 125 cm (39.4" x 49.2") without
CEPH
• 177 x 125 cm (69.7" x 49.2") with
CEPH
Weight • 135 kg without CEPH
• 150 kg with CEPH
Column weight 72 kg
Weight of arm support, rotating arm and 48 kg
tube head
Cassette holder weight 7 kg
Weight of the chin rest arm 8 kg
Environmental features
Working area (please refer to paragraph • 130x130 cm (51.2"x51.2") without
5.3 of the Service Manual) CEPH
• 130x190 cm (74.8"x51.2") with CEPH
Minimum height ceiling (please refer to 250 cm (98.5”)
paragraph 5.3 of the Service Manual)
Temperature in working condition + 10° ÷ + 40°
RH (related humidity) in working 30% ÷ 75%
condition
Temperature for transport and storing - 20° ÷ + 70°
Humidity for transport and storing < 95% without condense
Min. atmospheric pressure for transport 630 hPa
and storing

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Technical specifications

5.1 Dimensions


Figure 4 - Base version

STRATO 2000 (120V) 24 (Rev. 0)


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Technical specifications



Figure 5 - Version equipped with cephalometric unit

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Technical specifications

5.2 Loading curve of the tube and cooling curve of the


anode

Tube "CEI - OPX/105" (0.5 IEC 336)

Load

Anode cooling curve

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Technical specifications

Cooling curve of Tubehead

E(KJ)
350

300

250

200

150

100

50

0
0 100 200 300 400 500
min

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Technical specifications

5.3 Applied safety regulations


STRATO 2000 complies with the following standard:

• 21 CFR subchapter J

• General safety:
IEC 601-1
IEC 601-1-1
IEC 601-2-7
IEC 601-2-28

• Electromagnetic compliance:
IEC 601-1-2

• Protection against radiations:


IEC 601-1-3
IEC 825-1

0434 The symbol CE grants that STRATO 2000 complies with


directives 93/42 for medical devices issued by the European
Community.

Classifications
STRATO 2000 is an electro-medical X-ray device belonging to Class I type
B as per classifications IEC 601-1, foreseen for a continuous working at
intermittent load.
According to CE 93/42 Directives for medical devices, the equipment
belongs to class II B.
According to FDA 21CFR, the equipment belongs to class II.

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Technical specifications

5.4 Note on the “Constant magnification” for


Panoramic and TMJ (close/open mouth) exposures

NOTE:
STRATO 2000 is based on a dentition and ascending rami shape as
defined by U. Welander et al., Dentomaxillofacial Radiology, 1989, Vol.
18, May.
This paper, based on statistic study, enstabilishes a form for the
dentomaxillofacial complex that it is assumed as “standard”. A projection
geometry that maintains a constant magnification stated in the technical
characteristics of each examination throughout the exposure of this
shape has been applied to the STRATO 2000. Patient’s anatomy can
differ in a significant way from the statistical model, so the magnification
factor is not maintained and can be different from that value. Based on
his experience and competence, the user has to judge this variation.

IN ANY CASE, THE PANORAMIC RADIOGRAPHY CANNOT BE USED


TO PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON
THE FILM.

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Technical specifications

5.5 Measurement method of technical factors


(Paragraph for the authorized personnel)

WARNING:
These measurements require the removal of the HF group covers; this
means to gain access to internal parts where high voltage are normally
present.

For the measurement of the exposure parameters with the invasive


method, please follow the procedure described in paragraphs 7.2 and 7.3
of the Service manual.

WARNING:
During the panoramic examination, the set value of kV and tube current
varies according to a pre-determined curve in order to compensate the
different absorption of X-ray beam due to different anatomical structures.
In this way, it is possible to obtain a good uniformity of the image’s
contrast. Particularly, the chosen value is lowered on the initial phase of
the panoramic and increased on the scissors/canine zone, in order to
compensate the effect of the cervical spine.
The value displayed during the panoramic examination corresponds to
the to chosen one, while the instantaneous value can be different; these
effects must be considered in case of measure of the exposure factors
using standard diagnostic mode (please refer to the Note at page 52).
Accuracy declared on the section “Technical data” is referred to the
actual value of kV and/or mA. In any case, manufacturer guarantees
that the accuracy of loading factors is always compliance with the
international standard for safety of medical devices IEC 601-1.
Particularly, in accordance with IEC 601-2-7, the maximum deviation
(including the correction and instrument’s accuracy) is less than or equal
to ±10 for kV, while for tube current is less than or equal to ±15%.

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Technical specifications

5.6 Verify method of exposure parameters


(Paragraph for the authorized personnel)
The exposure parameters can also be checked using the so called “non-
invasive method”. This method requires the use of a specific instrument,
identified as a "probe" in Figure 6.

NOTE:
The instruments normally used for the measurement of the exposure
parameters (kVp) with the non-invasive method, have an intrinsic
measurement non-linearity when used to measure low dose radiations.
This non-linearity can lead to measuring errors clearly not due to the
STRATO 2000.
As example, please see the next diagram where the sensitivity curve of a
normal measuring instrument is shown. Working outside the dark area,
the instrument is not linear.

The exposure parameters can be checked with a non-invasive instrument


by performing the following procedure:

1. With the unit on, select the Panoramic examination mode by pressing

key "17" .

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Technical specifications

2. Press keys "10" , "28" and "24" at the same

time. LED’s of "patient type", "patient size" and "Arch" switch

off and the display shows the following two messages alternatively:

R E M O V E
C H I N R E S T

and

C L O S E
T E M P L E S U P P O R T

NOTE:
The following operations is a confirmation that the above points have
been performed.

3. Carry out the actions mentioned above; press key "23" ;

the unit will carry out a movement to reach the "zero" position.

During this phase, the display shows:

P L E A S E W A I T . . .

Once the "zero" position is reached, the display will show the
following message:

O P E N
C A S S E T T E U N I T

4. After opening the cassette holder to Ceph position (this action is


sensed by the unit which monitors the status of microswitches S25),
the display shows:

P L E A S E W A I T . . .

In the mean time, the unit sets the primary collimator to position
18x24 symmetric (Slot #5) and the Soft Tissue Filter in position “not
in field”; at the end of the positioning phase, the display shows:

R X P A R A M E T E R S
7 0 k V 0 8 m A 1 . 0 0 S

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Technical specifications

5. Place the measuring instrument over the chin support as shown in


Figure 6.

6. Acting on key "4" and "7" and on keys "3" or

"6" set the exposure parameters to carry out the desidered

checks.
The variation range of the parameters is shown in the following table
(see also NOTE at page 31):

Parameter Minimum value Maximum value


kV 50 80
s 0,2 15

Table 2

NOTE:
Acting on key "5" and then on keys "3" or "6" the

mA value can be changed.


The mA value ranges from 4 to 12 (1 mA step).

PROBE

Figure 6

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Technical specifications

WARNING:
X-ray will be emitted during the performance of the following operations.
Authorised technicians are therefore recommended to use the greatest
caution and to comply with the safety regulations and laws of the of their
country.

7. Perform an exposure; the emitted parameters (kV and Time) can be


read on the measuring instrument.

NOTE:
The performances are guaranteed if the measurement of kV and it is
done with the invasive method.

To quit this routine, press key "9" ; the display will show:

C L O S E C A S S E T T E
T O P A N O R A M I C

After closing the cassette holder to Panoramic position (the position is


sensed by the unit through microswitch S24), the display will show the
following message:

P R E S S E N T E R

Press key "23" ; the unit will carry out the zeroing and will set

itself in the patient entry position; the display will first show:

P L E A S E W A I T . . .

then

x x k V x x m A 1 5 . 0 s

and the unit returned at a standard mode.

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General instructions for use

6. GENERAL INSTRUCTIONS FOR USE

6.1 Control panel - Descriptions and functions


STRATO 2000 keyboard is divided into 8 functions areas, and a display
to view the messages and the error codes.
Next figure shows a general view of the keyboard, while details an each
functional area are provided in the following pages.

Signal LEDs Anatomical selection

Luminous
centering
devices

Command
confirm.
LED

Carriage
movement
(canine
plane)

Exam.
setting
key

Control keys Examination mode selection Column movement

Exposure parameters
manual selection

Figure 7

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General instructions for use

Implant Sinus
Cephalometric

Each key enables the selection of a


specific examination. The pre-set
examinations are:
Panoramic – TMJ open/closed mouth,
TMJ biaxial, Implant, Sinus,
Cephalometry.

TMJ open/closed
mouth
Biaxial TMJ Panoramic

It is possible to select the examinations


automatically (anatomic selection)
using pre-fixed exposure values. This
kind of selection enables to choose
between Adult/Child, each with three
different sizes (small, medium, large);
for Panoramic, TMJ open/closed
mouth, and Implant there is the
possibility to chose among three
different dental arches.

In panoramic and TMJ examination


mode, the system allows the selection of
Large the type of the dental arch.
The arch key allows the selection
among 3 different mouth
Medium conformations: narrow - medium -
large.
The selection made is confirmed by the
Narrow activation of the corresponding LED.
The arch selection does not influence
the values of kV and mA but acts on
the position of the focus layer.

Furthermore there is the possibility to


select manually the exposure
parameters; in this case select at first
the parameter to be changed and
secondly, using the increasing and
reducing keys, set the required value.
The parameters available are: kV, mA
and time. The latter just for
cephalometry.

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General instructions for use

This area contains the keys which control


the tubehead arm movements (canin Command
confirm.
plane) during the patient positioning, and LED
the relevant confirmation key. When the
"Command confirmation LED" is lit, it

means that the key , must be Setting


key

pressed to confirm the selected


command.

There are two light indicators; the first


one on the left indicates the condition
"Machine Ready", indicating the user that
by pressing the X-ray button key once
more, X-rays emission will start; the
second led indicates the emission of
X-rays.

The movement of the column is


controlled by the related keys; for
safety’s sake, this control is performed
pressing two keys at the same time,
the central one and one of the two
lateral.

The left button is dedicated to the center


of sagittal, canine and Frankfurt planes,
thus adapting the STRATO 2000 to the
patient anatomy.
The right button is reserved for future
use.

Apart from the keys dedicated to the


selection of the examination functions,
part of the STRATO 2000 keyboard is
dedicated to the services. From left to
right, we have: the "Test" key (which
disables the X-ray emission during
arm rotation), the "Reset" key (to be
pressed after the unwanted release of
the X-ray push button "30" during
exposure) and the "Arm return" (to
prepare the system for the next
examination).

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General instructions for use

6.1.1 Key function description

Figure 8 - Control panel

LEGEND:
Messages Examination mode
Display: indicates operative messages, warnings and 14 - Implant (Optional)
exposure parameters. 15 - Cephalometry (Optional)
16 - Sinus examination (Optional)
Signal lights 17 - Panoramic
1 - Led indicating the machine is ready for X-ray 18 - TMJ closed mouth – open mouth
emission (green LED) 19 - TMJ biaxial / TMJ P/A (Optional)
2 - Yellow LED indicating X-rays emission
Centring devices
Manual setting of exposure parameters 20 - Saggital, Frankfurt and Canine Plane centring unit
3 - kV, s or mA increasing 21 - Button not active
4 - Seconds
5 - milliAmpere Patient centring
6 - Reduction of kV, s or mA 22 - Moving canine plane / choise tooth (Implant)
7 - KVolt 23 - Enter key
24 - Button choice: cassette (Ceph), arch (Implant)
Preparation functions 25 - Moving canine plane / choice tooth (Implant)
8 - Key to set Test function 26 - Button choice: cassette (Ceph), arch (Implant)
9 - Reset, axes alignment and enabling to modify
exam modes
10 - Positioning of the rotation unit to start the Height adjustment
selected examination or return of the unit for a 27 + 28 - Column up
new setting 29 + 28 - Column down
Anatomic selection
11 - Adult or Child (green LED)
12 - Small, medium or large size (green LED)
13 - Wide, normal or narrow arch (for Panoramic,
TMJ and Implant exposure) (green LED)

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General instructions for use

6.2 “Switching ON” the device


Press the green button on the base of the column to switch the system
on. The LED on the control panel and the following display message,
indicate an auto-diagnosis is on the run:

S T R A T O X
R E L E A S E * . * *

After 3 seconds, the display shows the following message:

> T E S T <

NOTE:
During this phase, STRATO 2000 does not perform any movement, it just
performs a series of checks which, in case of negative result, could
require the intervention of the technician.
The only problem that can be solved by the user is related to the position
of the cassette holder PAN; in this case, the following message will be
displayed:

C L O S E C A S S E T T E
T O P A N O R A M I C

Once the auto-diagnosis is complete, the LED of the confirmation request

button will light; press "23" key to start the alignment phase of

motors; while waiting the display will show the following message:

M A C H I N E S E T T I N G

Once ENTER has been pressed, the related LED goes OFF and the
display shows the following message during the alignment of axes:

W A I T F O R
M A C H I N E S E T T I N G

WARNING:
During this phase, the machine checks for possible obstacles that may
create collisions simulating the movements performed during the
examination.
During this phase the machine also carries out the following actions:
• counts the motor steps of the cassette path and then position the
cassette in such a way to be accessible to the operator
• moves the carriage in the proper position for the centering of the
canine laser on standard plane.

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Once the alignment is done, the software indicates the position of the
cassette holder and the presence of the cassette into its holder.
If the cassette is found in place, the following message is displayed:

R E P L A C E
C A S S E T T E

NOTE:
No operations are available if cassette is not removed.

WARNING:
The position of the identification characters "R" (right side) and "L" (left
side) are correct if the cassette is fit into the unit with the hinges
positioned upward.

After 3 seconds, the following configuration will be automatically set by


the system:
• ADULT : the upper led of key "11" switches ON
• MEDIUM SIZE: the central led of key "12" switches ON
• MEDIUM ARCH: the central led of key "13" switches ON
• PAN: the central led of key "17" switches ON
LED "23" remains ON and the display shows, for example:

S T D . P A N O R A M I C
7 4 k V 1 0 m A 1 5 . 0 s

MACHINE IS READY

NOTE:
The above mentioned condition is chosen also in case for any reason the
device repeats the initialisation phase.

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General instructions for use

6.3 Positioning of chin support


STRATO 2000 is equipped with two different chin supports: a standard
one and one dedicated to edentulous patients.
The standard chin support must be used, in panoramic and biaxial TMJ
mode, with all the people who can assure a tight bite on the centering
bite.
The edentulous chin support instead must be used in two different
conditions:
• In panoramic and biaxial TMJ examination it must be used with
edentulous patients only.
• In TMJ (open and closed mouth) and Biaxial TMJ it must be used
with all patients.
Two parts compose the chin support: the base and the real chin support.
The base part can be installed on the arm in two different positions:
• Standard position (see Figure 9 part. 1 and 3): the side of the base
marked with “L” towards the front part of the chin support.
• Raised position (see Figure 9 part. 2 and 4): the side of the base
marked with “H” towards the front part of the chin support. This
positioning can be chosen when the vertex of the chin has to be more
seen on the film.

NOTE:
When the chin support is in raised position, perform a TEST examination
to make sure that, during arm rotation, there is no collision between the
tubehead and the shoulder of the patient.

1: Chin support in low 2: Chin support in up


position position

3: Edentulous chin support in 4: Edentulous chin support in up


low position position

Figure 9

NOTE:
Always remove the chin support when performing Ceph examinations.

(Rev. 0) 41 STRATO 2000 (120V)


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General instructions for use

6.4 Panoramic examination


When making a panoramic examination, the tubehead support arm
(X-rays generator) and the film cassette holder make a continuously
rotating movement.
After an initial acceleration, rotation is made at a constant speed. The
movement of the film cassette holder is not made at constant speed since
the relative movement of the cassette with respect to the rotation speed
determines the position and thickness of the focused layer. The X-rays
are emitted only when the rotating arm is at constant rotation speed.

6.4.1 Getting started

When the unit is switched on, the Panoramic Examination is selected as


default. If the operator has previously made another kind of examination
and wishes to make a Panoramic Examination, this is selected using key

"17" .

The system sets to the following configuration:


• ADULT: the upper LED of button "11" lights up
• MEDIUM SIZE: the central LED of button "12" lights up
• MEDIUM ARCH: the central LED of button "13" lights up
• PANORAMIC: the LED of button "17" lights up
LED "23" is lit and the default parameters (if this is the first exposure) or
the radiological parameters (kV and mA) used in the last examination are
displayed. For example:

S T D . P A N O R A M I C
7 4 k V 1 0 m A 1 5 . 0 s

Once the settings have been completed, the chin support must be placed
in position (see the operative notes in paragraph 6.3).

Pressing once again the button "17" will change the selected

modality of the panoramic examination from standard to "EMI


PANORAMIC RIGHT" to "EMI PANORAMIC LEFT". This selection is a
toggle one, so pressing the button repeatedly will change the selected
modality. The "EMI PANORAMIC" mode, right or left, means that only the
corresponding half mouth is irradiated; the emission will take place only
from the beginning to slight more the mid sagittal plane for right emi
panoramic. For left emi panoramic modality, the emission will start slight
before the mid sagittal and last until the end of rotation.

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These two kinds of examinations are useful when it is already known


that the patient has a problem on only one half of the mouth, so it is
possible to reduce the irradiation of the patient.

NOTE:
If Advanced Dental Applications (A.D.A.) option is enabled, multiple

selection of key "17" will toggle the "Improved orthogonality

Panoramic" function.

• Improved orthogonality Panoramic


The improved orthogonality Panoramic delivers the image of the pure
dental arch cutting out from the image the ascending rami branches
of the temporo mandibular joint; the trajectory of the rotating arms
optimized for a better orthogonality between the X-ray beam and the
incident sections of near teeth. Thus the image has reduced
overlapping between teeth, improving the diagnosis of interproximal
caries.

As a consequence of the different trajectory, the focus layer, mainly


in the front teeth area, is smaller and then patient positioning for this
examination needs more care.

Follow the instruction for normal Panoramic for patient


positioning.

NOTE:
STRATO 2000 is based on a dention and ascending rami shape as
defined by U. Welander et al., Dentomaxillofacial Radiology, 1989, Vol.
18, May.
This paper, based on statistic study, enstabilishes a form for the the
dentomaxillofacial complex that it is assumed as “standard”. A projection
geometry that maintains a constant magnification stated on the technical
characteristics of each examination throughout the exposure of this
shape has been applied to the STRATO 2000. Patient’s anatomy can
differ in a significant way from the statistical model, so the magnification
factor is not maintained and can be different from that value. Based on
his experience and competence, the user has to judge this variation.

IN ANY CASE, THE PANORAMIC RADIOGRAPHY CANNOT BE USED


TO PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON
THE FILM.

(Rev. 0) 43 STRATO 2000 (120V)


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General instructions for use

6.4.2 Anatomic / Manual exposure

NOTE:
If the previous examination had been made manually, press key

"17" to switch to anatomic exposure.

Once the unit has been correctly set, the following two operating modes
may be selected:
• ANATOMIC: with the kV and mA values programmed according to
the type of patient and size.
• MANUAL: with the possibility of varying the default kV and mA
values.

NOTE:
In manual condition, the LED on the PANORAMIC function key

"17" , and the Adult / Child led "11" flash so that it is possible to

change the selection; press key "11" to change from Adult to

Child.

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General instructions for use

6.4.2.1 Anatomic exposure

Select the type of patient using the Adult / Child key.


Select the patient size using the Size small - medium - large key.
The kV and mA settings selected are displayed as per Table 3.

Exposure values in PAN mode


Adult Child
(15 sec.) (13,5 sec.)
kV mA kV mA
Small 70 10 66 8
Medium 74 10 68 8
Large 76 10 70 9

Table 3

These values are set according to the recommended film-screen


combination.
Select the mouth structure using the Arch wide - medium - narrow

key .

NOTE:
The type of Arch does not influence the kV and mA values but does
influence the position of the focused layer.

(Rev. 0) 45 STRATO 2000 (120V)


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General instructions for use

6.4.2.2 Manual exposure

If the kV and mA combinations of the above table are not considered


suitable for a specific examination, it will be possible to set new
parameters using the manual mode.

To change the kV or mA values, press key "7" , or key "5" .

The LED on the Patient Size key switches off and the Adult / Child and
Panoramic keys will flash. One of the two following messages will be
displayed:

> 7 4 k V 1 0 m A 1 5 . 0 s

or

7 4 k V > 1 0 m A 1 5 . 0 s

The symbol ">" indicates which parameter is being changed.

The selected parameter can be changed using the increase key "3"

and decrease key "6" .

The kV value can vary between 50 and 80 kV, with 2 kV steps.

The mA value can vary between 4 and 10 mA, with 1 mA steps.

NOTE:
To change the values rapidly, keep the increase key "3" or

decrease key "6" pressed.

Select the mouth structure using the Arch wide - medium - narrow

key .

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General instructions for use

Panoramic positioning

Legend - Patient Positioning and


Centering Devices

1 Panoramic chin rest


2 Bite rod
3 Centering bite
4 Temple support rod
5 Adjustment knob for Frankfurt
plane laser
6 Adjustment knobs for temple
support

Figure 10

Legend - Reference Lines

45 Mid-sagittal line
46 Frankfurt plane line
47 Canine centering line
45 46

47

Figure 11

(Rev. 0) 47 STRATO 2000 (120V)


USER'S MANUAL
General instructions for use

6.4.3 How to prepare the patient

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hairpins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.
2. Provide the patient with a protective apron or similar protection.
Ensure that the protection device does not interfere with the path of
the X-rays beam.
3. Place the patient in a standing position at the chin support. Using

"27+28" keys (up) or "29+28" (down)

raise/lower the column until the chin support rest is aligned with the
patient's chin.
4. Position the patient at temple support "4" (Figure 10), resting the
chin on the support base "1". The hands should rest on the front
handles. Ask the patient to bite the reference notch of bite "3" on rod
"2" (Figure 10) with his incisors. In case of edentulous patients,
he/her must rest the chin against the reference shoulder of the
edentulous chin support.
5. Instruct the patient to close the eyes.

6. Press button "20" to switch ON the laser centering device.

Three laser beams will light up the mid-sagittal plane line "45", the
horizontal line for the Frankfurt plane reference "46" (the plane that
identifies a line that ideally links the ear hole - the auditory meatus -
with the lower part of the orbital fossa in Figure 11) and the canine
plane line "47" (Figure 11). Position the patient's head in such a way
as to ensure that the luminous beams fall in correspondence of the
respective anatomical references; if it is necessary to adjust the
position of the canine laser beam, the rotating arm can be positioned

using the key "22" or key "25" , until a perfect

alignment of the canine centering device "47" (Figure 11) with the
canine tooth is obtained. If the keys are kept pressed the speed of the
canine laser beam movement is increased.
The luminous beam of the Frankfurt plane can be adjusted according
to the height of the patient. This adjustment is made using knob
"5" (Figure 10) located on the side of the tubehead.

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General instructions for use

7. At this point, the patient must move his feet towards the keyboard
making sure to maintain the head within the above mentioned
pre-aligned anatomical references. In this way, a greater
straightening of the spine in the cervical area is obtained and
collision between the cassette holder and the patient's shoulder is
prevented. Check that the Frankfurt plane is still horizontal.
8. Also, close the temple support acting on the two knobs "6" (Figure
10). The temple support will help the patient to stay in a correct
position. Check that, during this phase, patient has not changed the
position.

9. Press key "23" to confirm. The confirmation request LED

switches off. The luminous centering devices switch off and the
rotating arm goes to its examination start position. Once alignment
has been completed, the following message will be displayed:

S T A R T E X A M
x x k V x x m A 1 5 . 0 s
x = value defined by the settings

NOTE:
The laser centering device remains lit until the button "20" is

pressed again or, upon completion of the alignment procedure, key

"23" is pressed to start exposure.

10. Make the following recommendations to the patient: the lips


must remain closed, the tongue must be placed towards the
palate, he/she must remain perfectly still and do not look at the
rotating arm during the movements.

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General instructions for use

6.4.4 Making an exposure

NOTE:

When key "8" is pressed, the Test function will be activated. In

this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays.
Once the cycle has been completed, deactivate the "Test" by pressing key
"8" again

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the X-rays (see Figure 1 and Figure 2).

1. Verify once again that the exposure data are correct, if not, correct
them as described in paragraph 6.4.2.2. Check that light unit ready
for X-ray "1" is ON, then press X-ray button "30" for the entire
duration of the exposure, ensuring that the X-ray light "2" is also lit
(if the unit is in view) and that the X-ray acoustic signal sounds. The
following message will be displayed first:

E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be displayed:

> X - R A Y <
x x k V x x m A 1 5 . 0 s
x = the value defined by the settings

NOTE:
If there is no cassette, the following message will be displayed:

> S T A R T E X A M <
I N S E R T C A S S E T T E

The examination will not be continued until the cassette has been
inserted.

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General instructions for use

WARNING:
The position of the identification characters "R" (right side) and "L" (left
side) are correct if the cassette is fit into the unit with the hinges
positioned upward.

NOTE:
The rotation of the arm and the emission of the rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man" control, it must be kept pressed until the end
of the exposure.

2. Once the exposure is completed, the system will rotate back to a


position where it is possible to make the patient to exit. At the end of
this movement, the following message will be displayed:

P A T I E N T E X I T
P R E S S → 0 ←

At this point, the patient can be freed from the positioning device.

NOTE:
If the examination is made in "Test" mode with the patient already in
position, he must not be removed from the temple support group to avoid
having to reposition him.

Press button "10" to return the unit to its initial position. This

movement can be stopped by pressing button "9" .

Now the system is ready to perform a new exam.

3. Press button "10" . The unit will return to its initial position

and the following message will be displayed:

P L E A S E W A I T . . .

WARNING:
During this phase the system stores into the internal memory some data.
Switching off the unit during this phase can lead to the loss of some
set-up data normally stored in the memory, which in turn may cause
irreversible damages to the system itself.
Do not switch off the unit in this phase.
If required, switch off the unit only when the green LED "23"
is lit.

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Then, the following message will be displayed:

R E P L A C E
C A S S E T T E

Once the cassette has been removed, LED "23" will light up
and the following message will be displayed:

x x k V x x m A 1 5 . 0 s
x = the value defined by the settings

that shows the values set for that last exposure. A new exposure can
now be made.

NOTE:
If you try to perform a new exam before the cooling period has elapse
(4 minutes) the following message will be displayed indicating the time to
wait before performing a new examination:

T U B E C O O L I N G
P L E A S E W A I T x x x s

This time enables the X-ray tube's anode to cool down.

4. Once the cassette has been removed, it can be opened in a dark room
and the film developed.

WARNING:
After every examination, clean the chin support, the handles and
the temple support thoroughly and change the rod and disposable
bite.

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NOTE:
If, during the exposure the patient moves or the unit collides with the
patient or with another structure, or the operator realizes that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays and the movement
of the arm.
If this occurs, the following message will be displayed:

E 5 6 1
P R E S S R E S E T

All the motors will be switched off and it will be possible, if necessary, to
manually rotate the arm allowing the patient to move away from the unit.
It is recommended that this movement be made with great care in
order to prevent damage to the machine.

Press button "9" . The following message will be displayed:

M A C H I N E S E T T I N G

Press key "23" . The following message will be displayed:

W A I T F O R
M A C H I N E S E T T I N G

and then:

R E P L A C E
C A S S E T T E

The system now returns to its initial position and the unit must be reset
(cassette and parameters) and the patient repositioned.

NOTE:
Remove the cassette and change the film to prevent a double exposure of
the film that would then provide non-diagnostic results.

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NOTE:
During the panoramic examination, the set values of kV and tube current
vary according to a pre-determined curve in order to compensate the
different absorption of X-ray beam due to different anatomical structures.
In this way, it is possible to obtain a good uniformity of the image’s
contrast. Particularly, the chosen value is lowered in the initial and end
sections of the panoramic and increased on the scissors/canine zone.
Tube current vary according to the kV, also if the set value is slightly
increased on the initial/end sections. These variations have the effect to
compensate the higher absorption of X-ray on the zone of the spinal
column. As an example, the variation follows the curve hereafter:

Set value Actual value mA

Actual value kV

The value displayed during the panoramic examination corresponds to


the to chosen one, while the real value can be different; in any case, the
system guarantees that accuracy of exposure factors is always according
to the international standard for safety of medical devices; IEC 601-1.
Particularly, in accordance with IEC 601-2-7, the maximum deviation
(including the correction according to the above curve and instrument’s
accuracy) is within ±10% for kV, while for tube current is within ± 15%.

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General instructions for use

6.5 TMJ examination

NOTE:
TMJ functions selection is possible only if the relevant function has been
enabled using the UCA (User Customizable Application) functionality.

The TMJ examination with open or closed mouth is similar to panoramic,


the only difference is that the exposure is performed only on the involved
area (Temporal mandibular Joint). then it stops and starts on the second
articulation. The operation sequence of the examination is therefore
similar to the one described for the panoramic.

The temporo-mandibular joint examination makes use of a projection


geometry giving an image of the condyle along a direction close to its
major axis, in order to achieve a clear view of its positioning inside the
cavity.
This TMJ function enables to obtain 4 different images on the same film,
by performing two rotational movements. The 4 images represent the
right and left condyle of the temporal-mandibular arch (TMJ) with closed
mouth and open mouth.
Selecting close mouth exam only the external sectors of the film are
exposed, while selecting open mouth exam, the exposure occurs on the
inner sectors.
The position of the images couples the images corresponding to the same
condyle to help a diagnosis. The Figure 12 shows the information related
to the single sectors.

RIGHT condyle RIGHT condyle LEFT condyle LEFT condyle


with closed mouth with open mouth with open mouth with closed mouth

1st exposure 3rd exposure 4th exposure 2nd exposure

R L
Figure 12

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General instructions for use

NOTE:
During TMJ the X-rays emission is not continuous since it is interrupted
during the transition phases between the different exposures, but is
necessary to keep pressed the X-ray button “30” for the whole rotation
time.
Do not release the X-ray button during the emission interruption if not
necessary.
The cooling phase of the tubehead occurs at the end of all 4 exposures.
In the CHILD position, exposure start is delayed by a few degrees with
respect to the ADULT position.

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General instructions for use

6.5.1 Getting started

Press key "18" to select TMJ.

NOTE:
TMJ function selection is possible only if the relevant function has been
enabled using the UCA (User Customizable Application) functionality.
If the option is not enabled the following message is displayed:

T M J O / C
E X A M N O T E N A B L E D

The system will set to the following configuration:


• ADULT : the upper led of key "11" switches ON
• MEDIUM: the central led of key "12" switches ON
• MEDIUM ARCH: the central led of key "13" switches ON
• TMJ mouth open/closed: the LED of key "18" switches ON
LED "23" lights up and the display shows the default exposure
parameters, if this is the first TMJ exposure, or the exposure parameters
(kV and mA) of the last exposure performed. For example:

7 4 k V 1 0 m A 1 0 . 5 s

Once the machine is set, position the chin-support if it had previously


been removed (see notes in paragraph 6.3).

NOTE:
STRATO 2000 is based on a dentition and ascending rami shape as
defined by U. Welander et al., Dentomaxillofacial Radiology, 1989, Vol.
18, May.
This paper, based on statistic study, enstabilishes a form for the
dentomaxillo-facial complex that it is assumed as "standard". A
projection geometry that maintains a constant magnification stated in
Technical Characteristics of each examination throughout the exposure
of this shape has been applied to the STRATO 2000. Patient’s anatomy
can differ in a significant way from the statistical model, so the
magnification factor is not maintained and can be different from that
value. Based on his experience and competence, the user has to judge
this variation.

IN ANY CASE, THE TMJ RADIOGRAPHY CANNOT BE USED TO


PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON THE
FILM.

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General instructions for use

6.5.2 Anatomic / Manual exposure

NOTE:
If the previous examination had been performed in manual mode, press

key "18" to enter the anatomic exposure mode.

After the machine has been set, one of the following modes can be
selected:
• ANATOMIC: with the kV and mA values programmed according to
the type and size of patient.
• MANUAL: with the possibility of changing the set kV and mA values.

NOTE:
The manual condition is indicated by the flashing TMJ function led

"18" , and by the flashing Adult/Child led "11" that enables the

operator to select the type of patient.

The selection is changed by pressing key "11" .

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General instructions for use

6.5.2.1 Anatomic exposure

Select the type of patient pressing the key Adult/Child.

Select the size of patient pressing the Size key small-medium-large.

The display will then show the kV and mA settings according to the
selections as per Table 4.

Exposure values in TMJ examination (10.5 sec)

Examination Adult Child


TMJ closed mouth
kV mA kV mA
& TMJ open mouth
Small 70 10 60 10
Medium 74 10 66 10
Large 78 10 70 10

Table 4

These values have been pre-set on the basis of the recommended film-
screen combination.
The time (10.5 sec.) refers to the sum of the four exposures (2 closed
mouth exposures and 2 open mouth exposures).

Select the mouth structure with the Arch key wide – medium -
narrow.

NOTE:
The type of Arch does not affect the kV and mA values but does affect the
position of the focal layer.

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General instructions for use

6.5.2.2 Manual exposure

If the kV and mA combinations in the above table are considered


unsuitable for a particular examination, new parameters can be set in
manual mode.

To change the kV or mA values press key "7" , or key "5" .

The Patient Size LED will switch off, the Adult/Child and TMJ keys will
flash. One of the following two messages will be displayed:

> 7 4 k V 1 0 m A 1 0 . 5 s

or

7 4 k V > 1 0 m A 1 0 . 5 s

The symbol ">" indicates which parameter is being changed.

Using keys "3" and "6" it is possible to increase or reduce

the value of the selected parameter.

The kV value ranges from 50 to 80 kV in 2 kV steps.

The mA value ranges from 4 to 10 mA, in 1mA steps.

NOTE:
Keep key "3" or "6" pressed to change the values rapidly as

required.

Select the mouth structure with the Arch key narrow-medium-large .

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General instructions for use

6.5.3 TMJ closed mouth

NOTE:
TMJ function selection is possible only if the relevant function has been
enabled using the UCA (User Customizable Application) functionality.
If the option is not enabled the following message is displayed:

T M J O / C
E X A M N O T E N A B L E D

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USER'S MANUAL
General instructions for use

6.5.3.1 Preparing the patient

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hair-pins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.
2. Provide the patient with a protective apron or similar. Ensure that
the protection device does not interfere with the path of the X-rays
beam.
3. Place the patient in a standing position at the edentulous chin

support. Using the "27+28" keys (up) or "29+28" keys

(down) raise/lower the column until the chin support

rest is aligned with the patient's chin.


4. If there are no functional problems in the joint, it is recommended to
use the panoramic byte to help the patient in holding a correct
positioning.

Reference lines

45 Sagittal median line


46 Frankfurt plane line

45 46

Patient positioning and


5
centering devices
6
4 1 Edentulous support
1 4 Temple support rod
5 Frankfurt plane laser
adjustment knob
6 Adjustment knobs for temple
support

Figure 13 – TMJ closed mouth positioning

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General instructions for use

5. Position the patient at temple support "4" (Figure 13). Rest the hands
on the front handles.
6. Instruct the patient to close the eyes.
7. Press the laser centering device ON key "20" . Three laser

beams will light the sagittal median plane "45", the horizontal line for
the Frankfurt plane reference "46" (the plane that identifies a line
that ideally links the ear hole - the auditory meatus - with the lower
part of the orbital fossa in Figure 13) and the canine plane line.
Position the patient's head in such a way that the first two light
beams correspond with the relative anatomical parts.
The luminous beam of the Frankfurt plane can be adjusted according
to the height of the patient. This adjustment is made using knob 5
(Figure 13) located on the side of the tubehead.
8. Also, close the temple support acting on the two knobs "6" (Figure
13). The temple support will help the patient to stay in a correct
position. Check that, during this phase, patient has not changed the
position.
9. Press key "23" to confirm. The confirmation request LED

switches off. The luminous centering devices switch off and the
rotating arm goes to its examination start position. Once alignment
has been completed, the following message will be displayed:

S T A R T E X A M
x x k V x x m A 1 5 . 0 s
x = value defined by the settings

NOTE:
The laser centering device remains lit until the laser centering device ON

button "20" is pressed or, upon completion of the alignment

procedure, key "23" is pressed to start exposure.

10. Make the following recommendations to the patient: the lips


must remain closed, he/she must remain perfectly still and do
not look at the rotating arm during the movements.

(Rev. 0) 63 STRATO 2000 (120V)


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General instructions for use

6.5.3.2 First exposure (Closed mouth)

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the rays (see the Figure 1 and Figure 2).

NOTE:
If deemed necessary it is possible to check the interference of the rotation
movement with the shoulder of the patient by activating the Test

function, pressing key "8" .

In this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays. The
test function of the TMJ open/closed mouth is the same as for panoramic
mode and so there will not be a second rotation corresponding to the
open mouth exam.
Once the cycle has been completed, deactivate the "Test" function and
press key "8" again.

1. Check once again that the exposure data are correct, if not, correct
them as described in paragraph 6.5.2.2. Check that the unit ready
for X-ray light "1" is on, then press X-ray button "30" for the entire
duration of the exposure, ensuring that the X-ray light "2" is also lit
(if the unit is in view) and that the X-ray signal sounds. The following
message will be displayed first:
E X A M
P R E - H E A T I N G
and then (after 2 seconds), the following message will be displayed:
> X - R A Y <
x x k V x x m A x . x x s
x = the value defined by the settings

NOTE:
If there is no cassette, the following message will be displayed:
> S T A R T E X A M <
I N S E R T C A S S E T T E
The examination will not be continued until the cassette has been
inserted.

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General instructions for use

WARNING:
The position of the identification characters "R" (right side) and "L" (left
side) are correct if the cassette is fit into the unit with the hinges
positioned upward.

NOTE:
The rotation of the arm and the emission of the X-rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man" control, it must be kept pressed until the end
of the exposure.
The X-rays emission to the central part of the dental arch is suspended
during the examination phase, the relative signals (sound and visual) are
therefore also suspended.

2. Once the exposure is completed, the system will carry out a short
return rotation and the following message is displayed:

P A T I E N T E X I T
P R E S S → 0 ←

it will then be possible to set-up the system for the open mouth
examination, keeping the patient in position or letting him free.

3. Press button "10" . The machine will return to its initial

position and the following message will be displayed

P L E A S E W A I T . . .

When the machine stops, the key "23" LED will light up and the
following message will be displayed:

I N S T R U C T P A T I E N T
T O O P E N M O U T H !

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USER'S MANUAL
General instructions for use

6.5.4 TMJ open mouth

NOTE:
TMJ function selection is possible only if the relevant function has been
enabled using the UCA (User Customizable Application) functionality.
If the option is not enabled the following message is displayed:

T M J O / C
E X A M N O T E N A B L E D

NOTE:
It is possible to carry out this examination with a new exposure on the
same film used for closed mouth TMJ.

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General instructions for use

6.5.4.1 Preparing the patient

1. The patient must be prepared following the operations described in


paragraph 6.5.3.1.
The following message will be displayed:

I N S T R U C T P A T I E N T
T O O P E N M O U T H

2. Press key "23" to confirm. The following message will be


displayed:

T M J P / C P H A S E 2
x x k V x x m A 1 1 . 0 s
x = value defined by the settings
3. Position the patient if he had been removed from the centering
device. Tell him to open his mouth (helping him to keep in position
using appropriate mechanical devices if necessary) and keep his chin
touching the edentulous chin support rest.
4. Put in a new panoramic byte: instruct the patient to place the inferior
scissors teeth against the lower part of the bite; this procedure will
help the patient to stay in a correct position during the exposure.

Reference lines

45 Sagittal median line


46 Frankfurt plane line

Patient positioning and


centering device

1 Edentulous support
4 Temple support rod
5 Frankfurt plane laser
adjustment knob
6 Adjustment knobs for temple
support

Figure 14 – Open mouth exam positioning

(Rev. 0) 67 STRATO 2000 (120V)


USER'S MANUAL
General instructions for use

5. Instruct the patient to close the eyes.

6. Press the laser centering device on key "20" . Three laser

beams will light the sagittal median plane "45", the horizontal line for
the Frankfurt plane reference "46" (Figure 14) and the canine plane
line. Position the patient's head in such a way that the sagittal
median plane is lit by the corresponding laser beam as per Figure 14.

7. After having positioned the head, close the temple support acting on
the two knobs "6" (Figure 14). The temple support will help the
patient to stay in a correct position. Check that, during this phase,
patient has not changed the position.

NOTE:
The laser centering device remains lit until the laser centering device ON

button "20" is pressed or, upon completion of the alignment

procedure, key "23" is pressed to start exposure.

8. Advise the patient to remain perfectly still and do not look at


the rotating arm during the movements.

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General instructions for use

6.5.4.2 Second exposure (Open mouth)

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the X-rays (see the Figure 1 and Figure 2).

WARNING:
Using the laser centering devices check that the system is still aligned
with the patient's sagittal median plane.

1. Press key "23" . The following message will be displayed:

S T A R T E X A M
x x k V x x m A 1 0 . 5 s

Check again that the exposure data are correct (see paragraph 6.5.2).

NOTE:
The Adult/Child and Size small - medium - large selection keys are
deactivated. The exposure parameters can be changed as described in
paragraph 6.5.2.

Press the X-ray key "30" for the entire time of exposure, at the same
time checking that the X-ray light “2” is lit (if the unit is in view) and
that the X-ray signal sounds. The following message will be displayed
first:

E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be


displayed:

> X - R A Y <
x x k V x x m A x x . x s
x = the value defined by the settings

(Rev. 0) 69 STRATO 2000 (120V)


USER'S MANUAL
General instructions for use

NOTE:
The rotation of the arm and the emission of the X-rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man" control, it must be kept pressed until the end
of the exposure.
The X-rays emission to the central part of the dental arch is suspended
during the examination phase, the relative signals (sound and visual) are
therefore also suspended.

2. Once the exposure is completed the system will rotate back. When it
stops, the following message will be displayed:

P A T I E N T E X I T
P R E S S → 0 ←

Now remove the patient from the positioning device.

3. Press button "10" . The machine will return to the patient

entry position and the following message will be displayed:

P L E A S E W A I T . . .

WARNING:
During this phase the system stores into the internal memory some data.
Switching off the unit during this phase can lead to the loss of some
set-up data normally stored in the memory, which in turn may cause
irreversible damages to the system itself.
Do not switch off the unit in this phase.
If required, switch off the unit only when the green LED "23"
is lit.

Then the following message will be displayed:

R E P L A C E
C A S S E T T E

When the cassette has been removed, LED "23" will light up
and the following message will be displayed:

x x k V x x m A 1 0 . 5 s
x = value defined by the settings

That shows the values set for the exposure just made. A new
exposure can now be made.

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General instructions for use

WARNING:
Clean the edentulous chin support, the handles and the temple support
thoroughly after each examination.

NOTE:
If, during the exposure the patient moves or the unit collides with the
patient or with another structure, or the operator realises that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays and the movement
of the arm.
If this occurs, the following message will be displayed:

E 5 6 1
P R E S S R E S E T

All the motors will be switched off and it will be possible, if necessary, to
manually rotate the arm and allow the patient to move away from the
unit. It is recommended that this movement be made with great care
in order to prevent damage to the machine.

Press button "9" . The following message will be displayed:

M A C H I N E S E T T I N G

Press key "23" . The following message will be displayed:

W A I T F O R
M A C H I N E S E T T I N G

and then:

R E P L A C E
C A S S E T T E

The system now returns to its initial position and the unit must be reset
(cassette and parameters) and the patient can be repositioned.

NOTE:
If the open mouth exposure is not completed, the closed mouth exposure
must be repeated or the four complete pictures will not appear on the
same plate.
No warning message will be given if the cassette is removed but the film
is not replaced, and another exposure is made. However, the film would
provide non-diagnostic results due to the double exposure.

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General instructions for use

6.6 Biaxial temporomandibular joint examination

NOTE:
TMJ function selection is possible only if the relevant function has been
enabled using the UCA (User Customizable Application) functionality.
If the option is not enabled the following message is displayed:

T M J B I A X I A L
E X A M N O T E N A B L E D

If the TMJ function is enabled, the biaxial examination is selected

pressing key "19" ; multiple selection of the same key will toggle

between biaxial TMJ and Front/Back projections TMJ.

The TMJ examination in biaxial mode will give an X-ray similar to the one
obtained with the TMJ open/closed mouth, i.e. four radiographed images
placed side by side, although the type of projection is essentially
different.

The scope of this examination is to determine whether the condyle is


correctly positioned in the mandibular fossa of the temporal bone. Each
joint is X-rayed twice at angles that show the condyle projected along its
longitudinal axis (frontal plane) and along its transversal axis inclined at
40° with respect to the longitudinal plane. The two images are placed side
by side to optimize diagnosis.

TMJ TMJ TMJ TMJ


Biaxial Biaxial Biaxial Biaxial

RIGHT Longitudinal Longitudinal LEFT


condyle axis of RIGHT axis of LEFT condyle
condyle condyle

1st 2nd 3rd 4th


exposure exposure exposure exposure

R L
Figure 15

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General instructions for use

NOTE:
During the biaxial TMJ examination, the X-rays emission is not
continuous since it is interrupted during the transition from one
exposure to another. Furthermore, the arm both rotates and translates
between the various exposures. Consequently the relative signals
(acoustic and visual) are also interrupted.

NOTE:
The arch selection is not available for this examination.

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6.6.1 Getting started

Press key "19" to select the Biaxial TMJ examination.

The following configuration is automatically set:


• ADULT: the upper led of key "11" lights up
• MEDIUM SIZE: the central led of key "12" lights up
• MEDIUM ARCH: the central led of key "13" lights up
• Biaxial TMJ: the LED of key "19" lights up
LED "23" lights up and the display shows the default exposure
parameters if this is the first Biaxial TMJ exposure made, or the exposure
parameters (kV and mA) used in the last exposure. For example:

7 4 k V 1 0 m A 1 0 . 5 s

Once the machine has been set, place the standard chin support in
position if it had been previously removed (see notes in paragraph 6.3).

NOTE:
STRATO 2000 is based on a dentition and ascending rami shape as
defined by U. Welander et al., Dentomaxillofacial Radiology, 1989, Vol.
18, May.
This paper, based on statistic study, enstabilishes a form for the the
dentomaxillofacial complex that it is assumed as "standard". A projection
geometry that maintains a constant magnification stated in Technical
Characteristics of each examination throughout the exposure of this
shape has been applied to the STRATO 2000. Patient’s anatomy can
differ in a significant way from the statistical model, so the magnification
factor is not maintained and can be different from that value. Based on
his experience and competence, the user has to judge this variation.

IN ANY CASE, THE TMJ RADIOGRAPHY CANNOT BE USED TO


PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON THE
FILM.

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6.6.2 Anatomic / Manual exposure

NOTE:
If the previous examination had been made in manual mode, press key

"19" to reset anatomic exposure.

Once the machine has been set, the following two modes may be selected:
• ANATOMIC: the kV and mA values have been programmed according
to the type of patient and size.
• MANUAL: with the possibility of changing the default kV and mA
values.

NOTE:
In manual condition, the LED on the Biaxial TMJ function key

"19" , and the Adult / Child led "11" flash so that the type of

patient may be selected. Press key "11" to change the selection.

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6.6.2.1 Anatomic exposure

Select the type of patient using the Adult / Child key.

Select the type of build using the Size small - medium - large key.

The kV and mA settings selected are displayed as per Table 5.

Exposure values in BIAXIAL TMJ examination (10.7 sec)

Examination Adult Child


TMJ Biaxial kV mA kV mA
Small 70 10 60 10
Medium 74 10 66 10
Large 78 10 72 10

Table 5

These values are set bearing in mind the recommended film-screen


combination.
The time (10.7 seconds) refers to the total 4 exposures.

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6.6.2.2 Manual exposure

If the kV and mA combinations of the above table are not considered


suitable for a specific examination, it will be possible to set new
parameters using the manual mode.
To change the kV or mA values, press key "7" , or key

"5" . The LED on the Patient Size key switches off and the

Adult / Child and Biaxial TMJ keys will flash. One of the two following
messages will be displayed:

> 7 4 k V 1 0 m A 1 0 . 5 s

or

7 4 k V > 1 0 m A 1 0 . 5 s

The symbol ">" indicates which parameter is being changed.

The selected parameter can be changed using the increase key "3"

and decrease key "6" .

The kV value can vary between 50 and 80 kV, with 2 kV steps.

The mA value can vary between 4 and 10 mA, with 1 mA steps.

NOTE:
To change the values rapidly, keep the increase key "3" or

decrease key "6" pressed.

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6.6.3 How to prepare the patient

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hairpins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.

2. Provide the patient with a protective apron or similar. Ensure that


the protection device does not interfere with the path of the X-rays
beam.

3. Place the patient in a standing position at the edentulous chin

support. Using "27+28" keys (up) or "29+28"

(down) the column until the chin support rest is

aligned with the patient's chin.

Legend - Reference lines

45 Mid-sagittal line
46 Frankfurt plane line
47 Canine centering line

Legend - Patient positioning and


centering devices

1 Edentulous support
2 Bite rod
3 Centering bite
4 Temple support rod
5 Adjustment knob for
Frankfurt plane laser
6 Adjustment knobs for temple
support

Figure 16 - Biaxial TMJ panoramic positioning

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4. Position the patient at temple support "4" (Figure 16), resting the
chin on the support base "1". The hands should rest on the front
handles. Ask the patient to bite the reference notch of bite "3" on rod
"2" (Figure 16) with his incisors. In case of edentulous patients,
he/her must rest the chin against the reference shoulder of the
edentulous chin support.
5. Instruct the patient to close the eyes.

6. Press the ON button "20" of the laser centering device. Three

laser beams will light up the mid-sagittal plane line "45", the
horizontal line for the Frankfurt plane reference "46" (the plane that
identifies a line that ideally links the ear hole - the auditory meatus -
with the lower part of the orbital fossa - Figure 16) and the canine
plane line "47" (Figure 16). Position the patient's head in such a way
as to ensure that the first two luminous beams fall in correspondence
of the respective anatomical references.
The luminous beam of the Frankfurt plane can be adjusted according
to the height of the patient. This adjustment is made using knob "5"
(Figure 16) located on the side of the tubehead.
7. Also, close the temple support acting on the two knobs "6" (Figure
16). The temple support will help the patient to stay in a correct
position. Check that, during this phase, patient has not changed the
position.

8. Press key "23" to confirm. The confirmation request LED

switches off. The luminous centering devices switch off and the
rotating arm goes to its examination start position. Once alignment
has been completed, the following message will be displayed:

S T A R T E X A M
x x k V x x m A 1 0 . 5 s
x = value defined by the settings

NOTE:
The laser centering device remains lit until the laser centering device ON

button "20" is pressed or, upon completion of the alignment

procedure, key "23" is pressed to start the exam procedure.

9. Make the following recommendations to the patient: the mouth


must remain closed, the tongue must be placed towards the
palate, he/she must remain perfectly still and do not look at the
rotating arm during the movements.

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6.6.4 Making an exposure

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the rays (see the Figure 1 and Figure 2).

NOTE:
If deemed necessary it is possible to check the interference of the rotation
movement with the shoulder of the patient by activating the Test

function, pressing key "8" .

In this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays. The
test function of the Biaxial TMJ is the same as for panoramic mode.
Once the cycle has been completed, deactivate the "Test" function and
press key "8" again.

1. Verify once again that the exposure data are correct, if not, correct
them as described in paragraph 6.4.2.2. Check that the unit ready
for X-ray light "1" is on, then press X-ray button "30" for the entire
duration of the exposure, ensuring that the X-ray light "2" is also lit
(if the unit is in view) and that the X-ray signal sounds. The following
message will be displayed first:

E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be displayed:

> X - R A Y <
x x k V x x m A x . x x s
x = the value defined by the settings

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NOTE:
If there is no cassette, the following message will be displayed:
> S T A R T E X A M <
I N S E R T C A S S E T T E
The examination will not be continued until the cassette has been
inserted.

WARNING:
The position of the identification characters "R" (right side) and "L" (left
side) are correct if the cassette is fit into the unit with the hinges
positioned upward.

NOTE:
The rotation of the arm and the emission of the X-rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man" control, it must be kept pressed until the end
of the exposure.
The X-rays emission to the central part of the dental arch is suspended
during the examination phase, the relative signals (sound and visual) are
therefore also suspended.

2. Once the exposure is completed, the system will rotate back to a


position where it is possible to make the patient to exit. Once the
movement is completed, the following message will be displayed:

P A T I E N T E X I T
P R E S S → 0 ←

At this point, the patient can be freed from the positioning device.

3. Press button "10" . The unit will return to its initial position

and the following message will be displayed:

P L E A S E W A I T . . .

WARNING:
During this phase the system stores into the internal memory some data.
Switching off the unit during this phase can lead to the loss of some
set-up data normally stored in the memory, which in turn may cause
irreversible damages to the system itself.
Do not switch off the unit in this phase.
If required, switch off the unit only when the green LED "23"
is lit.

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Then, the following message will be displayed:

R E P L A C E
C A S S E T T E

Once the cassette has been removed, LED "23" will

light up and the following message will be displayed:

x x k V x x m A x x . x s
x = the value defined by the settings

that shows the values set for that last exposure. A new exposure can
now be made.

NOTE:
If you try to perform a new exam before the cooling period has elapsed (4
minutes), the following message will be displayed indicating the time to
wait before performing a new examination:

T U B E C O O L I N G
P L E A S E W A I T x x x s

This time enables the X-ray tube's anode to cool down.

4. Once the cassette has been removed, it can be opened in a dark room
and the film developed.

WARNING:
After every examination, clean the chin support, the handles and
the temple support thoroughly and change the rod and disposable
bite.

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NOTE:
If, during the exposure the patient moves or the unit collides with the
patient or with another structure, or the operator realises that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays and the movement
of the arm.
If this occurs, the following message will be displayed:

E 5 6 1
P R E S S R E S E T

All the motors will be switched off and it will be possible, if necessary, to
manually rotate the arm and allow the patient to move away from the
unit. It is recommended that this movement be made with great care
in order to prevent damage to the machine.

Press button "9" . The following message will be displayed:

M A C H I N E S E T T I N G

Press key "23" . The following message will be displayed:

W A I T F O R
M A C H I N E S E T T I N G

and then:

R E P L A C E
C A S S E T T E

The system now returns to its initial position and the unit must be reset
(cassette and parameters) and the patient can be repositioned.

NOTE:
Remove the cassette and change the film to prevent a double exposure of
the film that would then provide non-diagnostic results.

NOTE:
As opposed to Panoramic exposure, the Biaxial TMJ examination is a
non-continuous exposure. There is a pause between each exposure
during which the machine positions itself for the next X-ray.

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General instructions for use

6.7 Sinus examination

NOTE:
SINUS functions selection is possible only if the relevant function has
been enabled using the UCA (User Customizable Application)
functionality.
If the option is not enabled, the following message is displayed:

S I N U S
E X A M N O T E N A B L E D

Sinus examination is selected pressing key "16" ; the display

shows the message:

M A X I L . S I N U S X
x x k V x x m A 1 0 . 4 s
x = the value defined by the settings

X, generally set to 0 (zero), identifies the position of the layer of concern

in the radiograph; using "22" and "25" keys it is possible to

modify this selection when requested by the particular morphology of the


patient. It is possible to move the layer up to +7 mm (more advanced
towards the front of the patient) or –7 mm (moved back towards the nape
of the patient).

Pressing Sinus again, it is possible to toggle the following examination:

M A X I L . S I N U S X
7 4 k V 1 0 m A 1 0 . 4 s

L A T . S I N U S R X
7 4 k V 1 0 m A 5 . 2 s

L A T . S I N U S L X
7 4 k V 1 0 m A 5 . 2 s

Selecting the lateral Sinus (right or left) it is possible to modify the


position of the layer of concern –3 mm (towards the median sagittal plane
of the patient) or +3 mm (towards the side of the patient).

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NOTE:
Images of Right lateral SINUS and Left lateral SINUS can be on the same
film; the two examinations can be carried out in sequence without
changing the film, but only sliding out an in the cassette.

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6.7.1.1 Preparing the patient

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hair-pins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.
2. Provide the patient with a protective apron or similar. Ensure that
the protection device does not interfere with the path of the X-rays
beam.
3. Place the patient in a standing position at the edentulous chin

support. Using the "27+28" keys (up) or "29+28" keys

(down) raise/lower the column until the chin support

rest is aligned with the patient's chin.


4. Position the patient at temple support "4" (Figure 17), resting the
chin on the support base "1". The hands should rest on the front
handles. Ask the patient to bite the reference notch of bite "3" on rod
"2" (Figure 17) with his incisors. In case of edentulous patients,
he/her must rest the chin against the reference shoulder of the
edentulous chin support.

Reference lines

45 Mid-sagittal line
46 Frankfurt plane line
47 Canine centering line

Legend - Patient positioning and


centering devices

4 Edentulous support
5 Bite rod
6 Centering bite
4 Temple support rod
5 Adjustment knob for
Frankfurt plane laser
6 Adjustment knobs for temple
support

Figure 17 – SINUS positioning

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General instructions for use

5. Instruct the patient to close the eyes.


6. Press the laser centering device ON key "20" . Three laser

beams will light the sagittal median plane "45", the horizontal line for
the Frankfurt plane reference "46" (the plane that identifies a line
that ideally links the ear hole - the auditory meatus - with the lower
part of the orbital fossa in Figure 17) and the canine plane line.
Position the patient's head in such a way that the first two light
beams correspond with the relative anatomical parts.
The luminous beam of the Frankfurt plane can be adjusted according
to the height of the patient. This adjustment is made using knob 5
(Figure 17) located on the side of the tubehead.
7. Also, close the temple support acting on the two knobs "6" (Figure
17). The temple support will help the patient to stay in a correct
position. Check that, during this phase, patient has not changed the
position.
8. Press key "23" to confirm. The confirmation request LED

switches off. The luminous centering devices switch off and the
rotating arm goes to its examination start position. Once alignment
has been completed, the following message will be displayed:

S T A R T E X A M
x x k V x x m A 5 . 2 s
x = value defined by the settings

NOTE:
The laser centering device remains lit until the laser centering device ON

button "20" is pressed or, upon completion of the alignment

procedure, key "23" is pressed to start exposure.

9. Make the following recommendations to the patient: the lips


must remain closed, he/she must remain perfectly still and do
not look at the rotating arm during the movements.

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General instructions for use

6.7.2 Making an exposure

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the rays (see the Figure 1 and Figure 2).

NOTE:
If deemed necessary it is possible to check the interference of the rotation
movement with the shoulder of the patient by activating the Test

function, pressing key "8" .

In this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays.
Once the cycle has been completed, deactivate the "Test" function and
press key "8" again.

5. Verify once again that the exposure data are correct, if not, correct
them as described in paragraph 6.4.2.2. Check that the unit ready
for X-ray light "1" is on, then press X-ray button "30" for the entire
duration of the exposure, ensuring that the X-ray light "2" is also lit
(if the unit is in view) and that the X-ray signal sounds. The following
message will be displayed first:

E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be displayed:

> X - R A Y <
x x k V x x m A x . x x s
x = the value defined by the settings

NOTE:
If there is no cassette, the following message will be displayed:
> S T A R T E X A M <
I N S E R T C A S S E T T E
The examination will not be continued until the cassette has been
inserted.

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WARNING:
The position of the identification characters "R" (right side) and "L" (left
side) are correct if the cassette is fit into the unit with the hinges
positioned upward.

NOTE:
The rotation of the arm and the emission of the X-rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man" control, it must be kept pressed until the end
of the exposure.
The X-rays emission to the central part of the dental arch is suspended
during the examination phase, the relative signals (sound and visual) are
therefore also suspended.

6. Once the exposure is completed, the system will rotate back to a


position where it is possible to make the patient exit. Once the
movement is completed, the following message will be displayed:

P A T I E N T E X I T
P R E S S → 0 ←

At this point, the patient can be freed from the positioning device.

7. Press button "10" . The unit will return to its initial position

and the following message will be displayed:

P L E A S E W A I T . . .

WARNING:
During this phase the system stores into the internal memory some data.
Switching off the unit during this phase can lead to the loss of some
set-up data normally stored in the memory, which in turn may cause
irreversible damages to the system itself.
Do not switch off the unit in this phase.
If required, switch off the unit only when the green LED "23"
is lit.

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Then, the following message will be displayed:

R E P L A C E
C A S S E T T E

Once the cassette has been removed, LED "23" will

light up and the following message will be displayed:

x x k V x x m A x x . x s
x = the value defined by the settings

that shows the values set for that last exposure. A new exposure can
now be made.

NOTE:
If you try to perform a new exam before the cooling period has elapsed (4
minutes), the following message will be displayed indicating the time to
wait before performing a new examination:

T U B E C O O L I N G
P L E A S E W A I T x x x s

This time enables the X-ray tube's anode to cool down.

8. Once the cassette has been removed, it can be opened in a dark room
and the film developed.

WARNING:
After every examination, clean the chin support, the handles and
the temple support thoroughly and change the rod and disposable
bite.

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NOTE:
If, during the exposure the patient moves or the unit collides with the
patient or with another structure, or the operator realises that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays and the movement
of the arm.
If this occurs, the following message will be displayed:

E 5 6 1
P R E S S R E S E T

All the motors will be switched off and it will be possible, if necessary, to
manually rotate the arm and allow the patient to move away from the
unit. It is recommended that this movement be made with great care
in order to prevent damage to the machine.

Press button "9" . The following message will be displayed:

M A C H I N E S E T T I N G

Press key "23" . The following message will be displayed:

W A I T F O R
M A C H I N E S E T T I N G

and then:

R E P L A C E
C A S S E T T E

The system now returns to its initial position and the unit must be reset
(cassette and parameters) and the patient can be repositioned.

NOTE:
Remove the cassette and change the film to prevent a double exposure of
the film that would then provide non-diagnostic results.

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6.8 IMPLANT examination


The linear tomography examination (Implant) has been implemented to
fulfil the emerging need of implant examination; in this way we make
easiest the pre surgical planning mode and also to follow up the post
surgical phase.
Essential requirements for a tomographic examination in the surgical
planning phase are to correctly determine the available space for implant;
these requirements comprise the lingual and vestibular contour, bone
thickness on the point of interest, position of the floor of the maxillary
sinus or the distance between the alveolar crest and the upper board of
the mandibular canal. All these structure are not adequately visualised
using a standard panoramic or periapicals radiographs.
Linear tomography technique make possible to answer to the above
requirements with a constant magnification factor (+37%) both in vertical
and horizontal direction, so making possible to perform measurements
directly on the film. Additional advantage of linear tomography comes out
from the dose reduction compared to the standard TC examination.

NOTE:
The presence of radio-opaque material close to the area under
examination may generate artifacts which make difficult a good
diagnosis.

Implant examinations can be conducted with two different modalities,


called reduced and complete implant respectively. First mode allows to
obtain two images of the point of interest, while the second mode obtains
four images; in both cases, examination is conducted in the same way.

The images, having a dimensions of 5x7cm, are placed side by side on


the same film. First image, the longitudinal allow a complete vision of the
interested zone while the other are transversal images (1 or 3) of the
selected point and allows to evaluate all the relevant dimensions (height
and bone thickness).

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1st Image: Longitudinal 2nd 3rd 4th Images: transversal

Figure 18

On these images, as already explained, considering the constant


magnification factor (+37%), it is possible to obtain the real values of
anatomical parts dividing the measure performed on the film by the
factor of 0.73.

For instance, if on the one radiography was measured a dimension of


3.57cm, thus real measure is equal to 3.57x0.73=2.6cm.

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6.8.1 Linear tomography programs

STRATO 2000 allows performing the linear tomography in two ways that
are very similar on the conduction of the examination but gives a
different result on film. The first mode, called “complete examination”,
results on a 4 radiographs: one longitudinal image and three cross ones;
of these last, the second one is centred on the point of interest. Referring
to Figure 19, the numbered slices are:
1: longitudinal image, centered on point of interest
3: transversal image, centered on point of interest
2 - 4: other transversal images

1 4
3
2

Figure 19

The second modality, called “reduced implant” gives two images, one
longitudinal and one cross, both centred on the point of interest.
Referring to Figure 20, numbered slices are, respectively:
1: longitudinal image, centered on point of interest
2: transversal image, centered on point of interest.

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USER'S MANUAL
General instructions for use

1
2

Figure 20

Please refer to paragraph 6.8.3 for detailed mode of selecting between two
modalities and also to paragraph 6.8.1.4 to have suggestions on how to
view images and their correct interpretation (please refer to Figure 26 and
following).

Advantage of the reduced mode can be summarised on the additional


dose reduction, so that mode can be used when a non perfect centring of
the point of interest is not important for the diagnosis; for instance in the
post surgical phase to judge the status of the implant’s bony integration.

(Rev. 0) 95 STRATO 2000 (120V)


USER'S MANUAL
General instructions for use

6.8.1.1 Examination preparation

For the correct execution of examination, which is detailed description is


given on paragraph 6.8.3, it is required to insert some anatomical
parameters, as well as some tomographic ones. Procedures on how to
position the patient and centering devices are clearly defined starting
from paragraph 6.8.2.

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USER'S MANUAL
General instructions for use

6.8.1.2 Anatomical parameters

The point of interest, i.e. the point where to perform the tomography, is
based on the statistical model of the dental arch. It is selected using the
standard European mode to number teeth, using two digits. The first
digit defines the quadrant (from 1 to 4) while the second digit identifies
the tooth itself, from 1 to 8. It means that selection of the point of
interest must be done by entering into the unit a two-digit number as
above described.
In case of use of the American standard, which is based on a different
method, see next Figure 21 where both European and American standard
numberings are provided, to find out the number (based on European
standard) to input into the unit.

American
Standard 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

European 18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28
Standard (*)

Patient Right side Patient Left side

European
Standard (*) 48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

American 32 31 30 29 28 27 26 25 24 23 22 21 20 19 18 17
Standard
(*) number to input into the unit

Figure 21

The linear tomography implemented on STRATO 2000 is based on a


statistical model of dental arch, as defined in international literature.
However, it must be considered that the natural deviation from the model
due to the individual variability can lead to the possibility that the point
of interest may be not perfectly centred on the middle of the tomographic
images.
To overpass that, STRATO 2000 uses the possibility to introduce
correcting factors that allows a better centring of the patient; these
factors are called longitudinal offset and transversal offset.

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USER'S MANUAL
General instructions for use

These offset values, that can be input on the system when it ask for
them, are measured with the following steps using longitudinal and
transversal images of the point of interest.

1. Place the radiograph on the lighted viewing plane, taking into


account that the longitudinal image is on the left whichever is the
interested teeth.

2. Place the special ruler (refer to Figure 24) on the film; care has to be
done on such a way to have the four lines (two upper and two on
lower) defining the limit of the image exactly on the borders of the
image (please refer to Figure 22). In this way, the central line of the
ruler, that now is exactly placed in the middle of the image, defines
the point of interest defined by STRATO 2000. Now measurements of
the offset can be made, having this line as a reference; the ruler has
also the positive and negative indication of the measures.

Second
Third
transversal
transversal
image (point of
image
interest)

Figure 22

3. Measure first, using the ruler, the distance from the real point of
interest to the reference line, considering also the sign: + if the
point of interest is on the right side of the reference line, - if it is on
the left one. This value is the longitudinal displacement; it has to be
input (if needed) on STRATO 2000 when display showa the following
message:
LONGIT OFFS:>+00
On the same way, it is possible to measure the transversal
displacement (offset).

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USER'S MANUAL
General instructions for use

4. Place now the special ruler (refer to Figure 23) on the film; care has
to be done on such a way to have the four lines (two upper and two
on lower) defining the limit of the image exactly on the borders of the
transversal (or cross) image of the point of interest. That image is the
third from the left (second transversal) in case of a complete exam or
the latest image in case of reduced exam. In this way, the central line
of the ruler, that now is exactly placed in the middle of the image,
defines the point of interest defined by STRATO 2000. Now
measurements of the offset can be made, having this line as a
reference; the ruler has also the positive and negative indication of
the measures.

Second
transversal
image (point of
interest)

Longitudinal
image

Figure 23

5. Measure, using the ruler, the distance from the real point of interest
to the reference line, considering also the sign: + if the point of
interest is on the right side of the reference line, - if it is on the left
one. This value is the langitudinal displacement (or longitudinal); it
has to be input (if needed) on STRATO 2000 when display shows the
following message:
TRANSV OFFS:>+00

Reference line for Point of


interest

Reference lines for Image


borders

Figure 24

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USER'S MANUAL
General instructions for use

6.8.1.3 Tomographic parameters

Resulting images are tomographic ones, so it is necessary to instruct the


system about the thickness and spacing transversal slices. On the
following Figure 25 all these parameters are defined.

Thickness (→g←) of
longitudinal slice: 4, 6 or 8 mm

Thickness (→g←) of
tranversal slice: 2, 3 or 4 mm

Spacing between transversal


slices: 2, 3 or 4 mm

Point of interest

Figure 25

The parameters defining the point of interest are called by in the


following sequence:
• Teeth selection
• Longitudinal slice thickness (→g←)
• Transversal slice thickness (→g←)
• Offsets
• Spacing between cross slices (only for complete mode).

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USER'S MANUAL
General instructions for use

6.8.1.4 Radiographic results

For a correct viewing of the images, we suggest to look at the images in


such a way to have the longitudinal view on the left side. The image
result is shown on Figure 26 for a complete examination; for a reduced
one, please refer to Figure 27, where the transversal image immediately
follows the longitudinal one.

Second
Longitudinal First transversal Third transversal
transversal image
image image image
(point of interest)

Figure 26

Transversal
Longitudinal
image
image
(point of interest)

Figure 27

With the film placed as above indicated, anatomical point are as per the
following paragraphs.

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USER'S MANUAL
General instructions for use

6.8.1.5 Right side tomography (quadrants 1 and 4)

In case of complete examination, longitudinal image placed in the left


position has the distal part of the mouth on the external side of the film
(left side of film), and the mesial part of the mouth on the inner part (at
right).
Exam starts from the distal to mesial, with cross images having
vestibular part on the left side and the lingual or palatal on the right side
(refer to Figure 28).
Vestibolar

Vestibolar

Vestibolar
Palatal /

Palatal /

Palatal /
Lingual

Lingual

Lingual
Mesial
Distal

First transversal Second Third tranversal


image transversal image image
Longitudinal
image
Point of
Distal interest Mesial

Figure 28

Same reference for reduced examination is referred to on the following


Figure 29.
Vestibolar

Palatal /
Lingual
Mesial
Distal

Coronal image
Longitudinal
image Point of
interest

Figure 29

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USER'S MANUAL
General instructions for use

6.8.1.6 Left side tomography (quadrants 2 and 3)

In case of complete examination, longitudinal image is placed in right


position has the mesial part of the mouth on the external side of the film
while the distal one of the mouth is on the inner part.
Exam starts from mesial to distal, with cross images having vestibular
part on the left side and the lingual or palatal on the right side (refer to
Figure 30).

Vestibolar

Vestibolar

Vestibolar
Palatal /

Palatal /

Palatal /
Lingual

Lingual

Lingual
Mesial

Distal

First transversal Second Third tranversal


image transversal image image
Longitudinal
image
Point of
Mesial interest Distal

Figure 30

For a reduced examination, references are contained on the Figure 31.


Vestibolar
Palatal /
Lingual
Mesial

Distal

Transversal
image
Longitudinal
image
Point of
interest

Figure 31

WARNING:
All images obtained with the Implant program have a magnification
factor of 1.37.

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USER'S MANUAL
General instructions for use

6.8.2 Positioning of the implant Bite Lock

To conduct the implant mode, STRATO 2000 is delivered with two special
“Implant bite block”, used to hold the patient on the point of interest: the
first bite block is used for the maxilla while the second one is used for
mandible (for simplicity, they will be referred to as: maxilla implant bite
block and mandible implant bite block).
Two parts make up both devices: a base support and a bite. Particularly,
the mandible implant bite block has been studied to hold the mandibular
border horizontal during the exam. To do this, the bite can be inclined
having two different angles.

STRATO 2000 (120V) 104 (Rev. 0)


USER'S MANUAL
General instructions for use

6.8.2.1 Bite block preparing: Maxilla Implant

1. Remove the standards bite block and insert the special implant bite
block for maxilla (main characteristics: cannot be inclined).
2. Insert the plastic bite, after its cold disinfecting, in the bite block
base (please refer to item 3 in Figure 32.
3. Take care that the plastic bite is on the lower position, in order to
assure that the area of interest will be irradiated (please refer to
Figure 32) To do this, unscrew the stopping mechanism using the
knob 1, place the bite 2 in the lowest position and fix the position
using the knob 1, in order to hold the bite in the correct position
during the examination.

Legend:

1 - Knob
2 - Bite
3 - Base

Figure 32

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USER'S MANUAL
General instructions for use

6.8.2.2 Bite block preparing: Mandible Implant

As already stated, this kind of examination has to be performed having


the patient’s head inclined in order to maintain the mandible border in
the point of interest most horizontal as possible; in this way radiographs
will be of better quality and with all clinical interesting points.

1. Remove the standards bite block and insert the special implant bite
block for mandible (main characteristics: can be inclined).
2. Insert the plastic bite, after its cold disaffection, in the bite block
base (please refer to item 5 in Figure 33).
3. Select the correct angle; according to the patient’s morphology: it
must be evaluated case by case. As suggestion, for all teeth it advised
to use the lower angle (refer to Figure 33A). It is possible, however for
some patient, depending on his morphology that the higher angle has
to be used. (please refer to Figure 33C) for posterior teeth. To do this,
referring to Figure 33B:
• unscrew the stopping mechanism using the knob 3
• place the bite block support 4 on the chosen angle
• hold the bite support on the position using the knob 3, in order
to hold the correct position during the examination.

NOTE:
We suggest to use, as a reference to check the horizontality of the
mandibular border, the laser beam normally used for the Frankfurt
plane. Then choose the correct angle.

4. Take care that the plastic bite is on the higher position, in order to
assure that the area of interest will be irradiated (please refer to the
Figure 33A). To do this, unscrew the stopping mechanism using the
knob 1, place the bite 2 in the highest position and fix the position
using the knob 1, in order to hold the bite in the correct position
during the examination.

Legend:

1 - Knob used to
fix the bite
2 - Bite
3 - Knob to fix the
angulation
4 - Bite block
5 - Base

Figure 33

STRATO 2000 (120V) 106 (Rev. 0)


USER'S MANUAL
General instructions for use

6.8.3 Equipment preparation

To select the IMPLANT mode, press button "14" .

The equipment will configure itself on the following configuration:


• ADULT, with the LED of the upper part of button "11" lighted on
• MEDIUM SIZE, with the LED of the upper part of button "12" lighted
on
• MEDIUM ARCH with the LED of the upper part of button "13" lighted
on
• IMPLANT with the LED of the upper part of button "14" lighted on
and with the LED "23" lighted on and the following message on the
display. For reduced examination:

T O O T H : 1 4
■ ■ ( 2 )

Another pressure of button "14" will select "Complete mode".

T O O T H : 1 4
■ ■ ■ ■ ( 4 )

After this selection, the procedure has to be completed with the


positioning of the implant bite block, in case of its removal from the
support; the implant bite block has to be chosen according to the maxilla
or mandible examination.

NOTE:
Before use, it is mandatory to perform a cold disinfecting of the plastic
bite using a, for instance, a 2% water solution of Glutaraldehydes
according to the instruction for use specified by its manufacturer.

NOTE:
CHILD selection cannot be performed.

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USER'S MANUAL
General instructions for use

6.8.4 Manual / Anatomic exposure

NOTE:
If previous exam was conducted on manual mode, to select the

"Anatomic" mode press button "14" during the visualisation’s

phase of exposure parameters (point 2 of paragraph 6.8.5).

During the implant selection, it is possible to chose to operate on one of


the two modes:
• ANATOMIC: with kV and mA pre-programmed on the system, based
on patient’s size and the choose tooth
• MANUAL: with the possibility to set kV and mA.

NOTE:
Manual mode is easily recognised by the blinking of the LEDS IMPLANT

"14" and Adult/CHILD "11" .

6.8.4.1 Anatomic exposure

Select the patient size, small, standard or large.

Based on the selected size, display will show the pre-set values for kV
and mA.
The pre-set value has been chosen based on the suggested combination
of film/screen.

Select the ARCH size, large, standard or narrow, using button .

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USER'S MANUAL
General instructions for use

6.8.4.2 Manual exposure

In case the pre-set values are judged not sufficient for exam/patient, it is
always possible to set values using the manual exposure mode.

NOTE:
In manual mode, take care that exposure parameters has to be set
considering the type of images they are referring to; in fact, for
longitudinal (or lateral) images kV value is increased passing from
posterior to anterior teeth, and must be higher for scissors/canine to
compensate the high X-ray absorption due to spine column. Vice versa,
for cross images the value has to be lower for scissors/canine and higher
for molar teeth.

To modify kV or mA, the button "7" , or button "5" has to

be pressed, respectively; in this way, the LED of button Patient size will
be switched off, while LEDs of buttons Adult/Child and Implant will
blink; display will show, per example, one of the following messages:

→ g ← L O N G I T : 6 m m
> 5 8 k V 0 7 m A 0 3 . 5 s

or

→ g ← T R A N S V : 4 m m
5 8 k V > 0 7 m A 0 3 . 5 s

while the symbol ">" will signal which parameter is to be modified.

Using buttons Increase "3" and Decrease "6" , it will be

possible to change the value of the selected parameter.

kV value can be changed in the range 50÷80 kV, step 2 kV.

mA value can be changed in the range 4÷10 mA, step 1 mA.

NOTE:
For a quick change, it is possible to speed up the process holding down

the Increase button "3" or Decrease "6" .

Select the Dental arch using the button Arch select large – medium (or

standard) – narrow .

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USER'S MANUAL
General instructions for use

6.8.5 Selection of anatomic and tomographic parameters

1. Select the teeth using button "26" or "24" ; in this way

it is possible to select teeth changing the second digit between 1

(scissors) and 8 (third molar). Acting on buttons "22" or

"25" , it is possible to change the first digit ranging from 1

(right maxilla) to 4 (left mandible). Please note that in anatomic mode


kV and mA changes accordingly to the selected teeth.

The setting is confirmed by pressing button "23" .

2. Display will visualise:


→ g ← L O N G I T : 6 m m
5 8 k V 0 7 m A 0 3 . 5 s
Set the longitudinal slice thickness in the range of values of 4, 6 or

8 mm using buttons "26" or "24" .

NOTE:
In case that values of kV or mA are considered not adequate, both for
longitudinal and/or cross image, it is possible to select a new exposure
parameter’ value using the method of manual exposure as described on
paragraph 6.8.4.

The selection has to be confirmed using button "23" .

3. Display will visualise the message:


→ g ← T R A N S V : 4 m m
5 8 k V 0 7 m A 0 3 . 5 s
Set the longitudinal slice thickness between values of 2, 3 or 4mm

using buttons "26" or "24" .

NOTE:
In case that values of kV or mA are considered not adequate, both for
longitudinal and/or cross image, it is possible to select a new exposure
parameter’ value using the method of manual exposure as described on
paragraph 6.8.4.

Set the chosen value using button "23" .

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General instructions for use

4. Display will show:

L O N G I T O F F S : > + 0 0
T R A N S V O F F S : > + 0 0

Input data of the offset for longitudinal and cross slices using

buttons "26" or "24" ; in this way it is possible to set

the correct value with its sign; using buttons "22" or "25"

it will be possible to change the offset in the range ±10units of the

ruler. Set values must be confirmed using button "23" .

If reduced implant has been chosen, jump to point 6.

5. If complete examination has been selected, display will show:

D I S T A N C E : 2 m m
5 8 k V 0 7 m A 0 3 . 5 s

Where the displayed values are those of the cross slices.

Select the spacing between cross slices in one of the values 2, 3 or

4 mm using buttons "26" or "24" .Confirm the set value

using button "23" .

6. Display will visualise:

P A T I E N T E N T R Y
5 8 k V 0 7 m A 0 3 . 5 s

Where the displayed values are those of the cross slices.

NOTE:
Indicated exposure time is strictly dependent on the selection of
tomographic images parameters.

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USER'S MANUAL
General instructions for use

6.8.6 How to prepare the patient

Patient’s preparation is the key factor in order to have diagnostic images,


because of the geometrical relations between STRATO 2000 and the
natural individual variability of patients. Following suggestions must be
adapted with the experience and the user radiological skill.

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hairpins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.
2. Provide the patient with a protective apron or similar protection.
Ensure that the protection device does not interfere with the path of
the X-ray beam.
3. Place the patient in a stranding position at the implant support.

Using the "27+28" keys (up) or "29+28" (down)

raise/lower the column until the implant support bite at a convenient


height.
4. Position the patient in the temple support 4 (Figure 34); ask the
patient to bite with his incisors against the reference notch of plastic
implant’s bite block, already prepared following the instructions of
paragraphs 6.8.2.1 and 6.8.2.2. The hands should rest on the front
handles.
5. Instruct the patient to close the eyes.

6. Press button "20" to switch ON the laser centring device. Two

laser beams will light up the mid-longitudinal plane line 45, the
horizontal line for the Frankfurt plane reference 46 (the plane that
identifies a line that ideally links the ear hole - the auditory meatus -
with the lower part of the orbital fossa in Figure 34 and Figure 35).
The laser beam of the Frankfurt plane must be adjusted, according to
the selected arch using knob 5 (Figure 34 and Figure 35) located on
the side of the tubehead and according to maxilla or mandible
examinations as follows:
• Maxilla: position the patient's head in such a way as to
ensure that the luminous beams fall in
correspondence of the respective anatomical
references (refer to Figure 34).
• Mandible: position the head of the patient in such a way as to
ensure that luminous longitudinal beam fall in
correspondence of the anatomical reference. Check,
using the Frankfurt laser beam, that mandibular
border at the point of interest is more horizontal than
possible (look at Figure 35).

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General instructions for use

Legend for reference planes:

45 Mid longitudinal plane


46 Frankfurth plane

45 46 Legend of patient’s centring


devices:
5

4 1 Maxilla implant bite block


1
2 Bite
4 Temple fixing device
6 5 Knob for Frankfurth laser beam
6 Adjustment knobs for temple
support

Figure 34: Maxilla position

Legend for reference planes:

45 Mid longitudinal plane

Legend of patient’s centring devices:


45

1 Mandible implant bite block


5 2 Bite
4 4 Temple fixing device
1
5 Knob for Frankfurt laser beam
6 Adjustment knobs for temple
6 support

Note:
For mandible examination, the
Frankfurt plane is not used; the
corresponding laser beam is used as a
reference to have the mandibular
border horizontal.
Figure 35: Mandible position

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USER'S MANUAL
General instructions for use

7. At this point, the patient must move his feet towards the keyboard. In
this way, a better straightening of the spine in the cervical area is
obtained thus improving the darkening of the radiography.
8. Also, close the temple support acting on the two knobs "6" (Figure 34
and Figure 35). The temple support will help the patient to stay in a
correct position. Check that, during this phase, patient has not
changed the position.

NOTE:
The laser centring device remains lit until the button "20" is

pressed again or, upon completion of the alignment procedure, button

"23" is pressed to start exposure.

9. Once alignment has been completed, the following message will be


displayed:

S T A R T E X A M
x x k V x x m A 1 5 . 0 s
x = value defined by the settings

10. Make the following recommendations to the patient: the mouth


must remain closed, he/she must remain perfectly still and do
not look at the rotating arm during movements.

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General instructions for use

6.8.7 Making an exposure

NOTE:
When key "8" is pressed, the Test function will be activated. In

this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays.
Once the cycle has been completed, deactivate the "Test" by pressing key
"8" again.

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the regulations in
force in the country where the machine is used.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the focal spot of the tubehead.

1. Press button "23" ; display will show:

S T A R T E X A M
x x k V x x m A 1 5 . 0 s

Verify once again that the exposure data are correct, if not, correct
them as described in paragraph 6.8.4. Check that light unit ready for
X-ray is ON, then press X-ray button "30" for the entire duration of
the exposure, ensuring that the X-ray light 2 is also lit (if the unit is
in view) and that the X-ray acoustic signal sounds. The following
message will be displayed first:

> S T A R T E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be displayed:

> X - R A Y <
x x k V x x m A Y . Y Y s
x = the value defined by the settings

during emission, while during intermediate movements the message

> X - R A Y <
x x k V x x m A Y . Y Y s
x = the value defined by the settings

will be displayed.

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NOTE:
Exposure values displayed are changing according to the selected mode
(longitudinal or cross).

NOTE:
If there is no cassette, the following message will be displayed:

> S T A R T E X A M <
I N S E R T C A S S E T T E

The examination will not be continued until the cassette has been
inserted.

NOTE:
The rotation of the arm and the emission of the rays will start with a
delay of 2 seconds from pressing the X-ray button "30". Since the X-ray
button is a "dead man control, it must be kept pressed until the end
of the exposure.

2. Once the exposure is completed, the system will rotate to its initial
position. At the end of this movement, the following message will be
displayed:

P A T I E N T E X I T
P R E S S → 0 ←

At this point, the patient can be freed from the positioning device.

NOTE:
If the examination is made in "Test" mode with the patient already in
position, he must not be removed from the temple support group to avoid
having to reposition him.

Press button "10" to return the unit to its initial position. This

movement can be stopped by pressing button "9" .

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3. Press button "10" . The unit will return to its initial position

and the following message will be displayed:

P L E A S E W A I T . . .

WARNING:
During this phase the system stores into the internal memory some data.
Switching off the unit during this phase can lead to the loss of some
set-up data normally stored in the memory, which in turn may cause
irreversible damages to the system itself.
Do not switch off the unit in this phase.
If required, switch off the unit only when the green LED "23"
is lit.

Then, the following message will be displayed:

R E P L A C E
C A S S E T T E

Once the cassette has been removed, LED "23" will light up

and the following message will be displayed:

T O O T H : 1 4
■ ■ ( 2 )

or

T O O T H : 1 4
■ ■ ■ ■ ( 4 )

According to the chosen mode. A new exposure can now be made.

NOTE:
If, once a cassette has been inserted or exposure values for another
patient have been set and a new exposure needs to be made, and less
than 4 minutes has expired from the end of the previous exposure, the
following message will be displayed indicating the time to wait before
performing a new examination:

T U B E C O O L I N G
P L E A S E W A I T x x x s

This time enables the tube's anode to cool down.

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4. Once the cassette has been removed, it can be opened in a dark room
and the film developed.

WARNING:
After every examination, clean the chin support, the handles and
the temple support thoroughly and change the rod and the bite.

WARNING:
After each use, the bite MUST be removed from the unit and disinfected
using commonly utilized solution like as Glutaraldehydes.
To perform this operation, the bite has to be removed from its base
loosening the knob “1” (Figure 32 and Figure 33). It is not necessary to
remove the knob completely, but loosing it as to allow the bite to freely
rotate; at this point the bite can be taken off sliding it up to the
maximum and eventually rotating it.

NOTE:
If, during the exposure the patient moves or the unit collides with the
patient or with another structure, or the operator realises that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays and the movement
of the arm.
If this occurs, the following message will be displayed:

E 5 6 1
P R E S S R E S E T

All the motors will be switched off and it will be possible, if necessary, to
manually rotate the arm allowing the patient to move away from the unit.
It is recommended that this movement be made with great care in
order to prevent damage to the machine.

Press button "9" . The following message will be displayed:

M A C H I N E S E T T I N G

Press key "23" . The following message will be displayed:

W A I T F O R
M A C H I N E S E T T I N G

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and then

R E P L A C E
C A S S E T T E

The system now returns to its initial position and the unit must be reset
(cassette and parameters) and the patient repositioned.

NOTE:
Remove the cassette and change the film to prevent a double exposure of
the film that would then provide non-diagnostic results.

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6.9 Cephalometric examination


There is no rotation of the tubehead (X-ray generator) support arm and
cassette holder for the cephalometric examination.
Various projections are possible for the cephalometric examination. The
diaphragm positions automatically according the cassette format and the
projection selected.
The cephalometric examination uses an adjustable filter called soft tissue
filter (STF). This filter reduces the dose in areas with low bone content
and highlights the patient's profile which, under normal conditions,
would be over-exposed and so not visible.

The STRATO 2000 makes different kinds of exposures, according to the


original configuration and the type of cassette used:

• INCHES

8"x10"
8"x10" Symmetrical for 10"x8" 12"x10"
Asymmetrical Antero-Posterior Asymmetrical Symmetrical
for Latero-Lateral and Postero- for Latero-Lateral for Latero-Lateral
Anterior

• 18 x 24 cm

18x24
18x24 Symmetrical for 24x18 30x24
Asymmetrical Antero-Posterior Asymmetrical Symmetrical
for Latero-Lateral and Postero- for Latero-Lateral for Latero-Lateral
Anterior

• 24 x 30 cm

24x30
18x24 Symmetrical for 24x30 30x24
Asymmetrical Antero-Posterior Asymmetrical Symmetrical
for Latero-Lateral and Postero- for Latero-Lateral for Latero-Lateral
Anterior

NOTE:
The size of the cassette is not automatically recognized by the unit but
must be input by the operator.

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NOTE:
The cephalometric examination may
also be used for radiographies made to
determine the current state of bone
calcification. For example, the
hand/wrist group can be X-rayed as
shown in Figure 36. To perform this
kind of exposure, the ear rods and
nose rest must be positioned as for the
postero-anterior cephalometric
examination.
To perform this kind of examination,
the exposure parameters allowed by
current regulations can give an
overexposed film. It is recommended
to use a cassette having a medium
type intensifying screen or a cassette Figure 36
with only one screen.
An alternative can be to set technique
factors at 60kV, 8mA, 0.5sec.

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6.9.1 Getting started

WARNING:
In order to make a radiographic examination that can be diagnosed, it is
important to position the cephalostat group for cephalometric
examination all the way down using knob "6" located on the ceph arm
close to the cassette holder (Figure 37). Otherwise, the ear rods will not
be aligned.
The cephalostat group can be positioned in a different position for
making examinations that require a larger view of the cervical vertebrae
areas.

Press key "15" to select the cephalometric examination.

The following two messages will be displayed alternatively:

C E P H - R E M O V E
C H I N R E S T

and

C E P H - C L O S E
T E M P L E S U P P O R T

The first message tells the operator to remove the chin support, while the
second message tells him to close the temple support. These operations
are necessary to prevent interference with the rays beam and with the
panoramic cassette holder when the arm is being positioned.

WARNING:
Neither of the two messages are controlled by the system and therefore
they can appear even if the unit has been set correctly.
These messages can be reset even if the unit has not been set
accordingly.

WARNING:
There is no need to position any type of chin support for the
cephalometric examination. The chin support used for panoramic
examinations must be removed as indicated on the display. If the chin
support is not removed, it will collide with the cassette holder during
alignment and can obscure some anatomical parts of the patient during
the examination.
At the same time, the temple support must be closed in order to avoid
collision with the rotating arm.

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1. Having completed the above, press key "23" . The two previous

messages will disappear and the machine will align automatically


with respect to the cassette and the following message will be
displayed:

C E P H
P L E A S E W A I T . . .

Once alignment is completed, the following message will be


displayed:

C E P H - O P E N
C A S S E T T E U N I T

requesting the operator to open the cassette holder for panoramic


examination.

NOTE:
The position of the cassette holder for panoramic examination is
controlled by two microswitches, it must therefore be completely opened.

The following message will be displayed:

8 x 1 0 A S T F = 0 8 . 3
7 0 k V 1 0 m A 0 . 8 0 s

NOTE:
The system sets to the following configuration:
• ADULT: the upper LED of button "11" lights up
• MEDIUM BUILD: the central LED of button "12" lights up
• CEPHALOMETRY: the LED of button "15" lights up
LED "23" lights up.

None of the leds of button "13" , Arch wide - medium - narrow

lights up during the cephalometric examination.

2. Insert the cassette ensuring that it is correctly aligned with the


reference marks on the support and lock it in with the round block.

NOTE:
The size and the orientation of the cassette is not automatically
recognized by the unit but must be input by the operator.

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3. With key "22" or key "25" it is possible to select the

size of the cassette and the type of projection (see the Table 6 at the
beginning of the chapter).

NOTE:
Exposure cannot be made if a cassette has not been inserted.

NOTE:
If the presence of a cassette is detected the system will ask for its
replacement before the exposure.
It is possible to erase this request, if the cassette had been replaced

earlier, by pressing key "9" .

NOTE:
The system does not detect if the film has already been exposed; if the
cassette has been removed, but the film has not been replaced the
exposure will be allowed, but the result will not be significant from the
diagnostic point of view.

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6.9.2 Anatomic / Manual exposure

NOTE:
If the preceding examination had been made manually, press key

"15" to change to anatomic exposure.

After having set the machine accordingly, the following two operating
modes may be selected:
• ANATOMIC: with the kV, mA and s values programmed according to
the type of patient and size
• MANUAL: with the possibility of changing the kV, mA and s values
set.

NOTE:
In manual condition, the LED on the CEPHALOMETRY function

key "15" , and the Adult / Child led "11" flash so that the type of

patient may be selected. Press key "11" to change the selection.

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6.9.2.1 Anatomic exposure

Select the type of patient with the Adult / Child key.

Select the type of build using the Size small - medium - large key.

The kV, mA and s values will be displayed according to the selections


made as per the following table:

Adult Child
kV mA s kV mA s
Small 74 12 0,8 72 11 0,9
Medium 76 12 0,8 74 11 0,9
Large 78 12 0,8 76 12 0,7
Table 6

These values have been set for latero-lateral projection, according to the
recommended film-screen combination. Different selections are used for
antero-posterior.

NOTE:
The Arch selection key is not activated.

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6.9.2.2 Manual exposure

If the kV, mA and s combinations of the above table are not considered
suitable for a specific examination, it will be possible to set new
parameters using the manual mode.
To change the kV or mA values, press key "7" , or key "5" .

The LED on the Patient Size key switches off and the Adult / Child and
Cephalometry keys will flash. One of the following messages will be
displayed:

8 x 1 0 A S T F = 0 8 . 3
> 7 0 k V 1 0 m A 0 . 8 0 s

8 x 1 0 A S T F = 0 8 . 3
7 0 k V > 1 0 m A 0 . 8 0 s

8 x 1 0 A S T F = 0 8 . 3
7 0 k V 1 0 m A > 0 . 8 0 s

The symbol ">" indicates which parameter is being changed.

The selected parameter can be changed using the increase key "3"

and decrease key "6" .

The "kV" value can vary between 60 and 80 kV, with 2 kV steps.
The "mA" value can vary between 4 and 12 mA, with 1 mA steps.
The "s" value can vary between 0.20 s and 3.00 s as per the following
table:

Exposure times selectable in manual mode


0,20 - 0,23 - 0,26 - 0,30 - 0,33 - 0,36 - 0,40 - 0,45 - 0,50 - 0,60
- 0,70 - 0,80- 0,90- 1,00 - 1,30- 1,60 - 2,00 - 3,00

NOTE:
To change the values rapidly, keep the increase key "3" or

decrease key "6" pressed.

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6.9.3 How to prepare the patient

1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hair-pins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.

2. Provide the patient with a protective apron or similar. Ensure that


the protection device does not interfere with the path of the X-rays
beam.

3. Open the ear centering device "4" (Figure 37) as wide as possible by
pressing open the upper part of the rods of the device. Push the nose
rest "2" (Figure 37) outwards as far as it will go. Manually rotate the
cephalostat group according the cephalometric projection to be made,
moving the upper part of the ear centering device "4" (Figure 37).

4. Place the patient in a standing position at the ear centering device.

Using the "27+28" keys (up) or "29+28" keys

(down) move the column until the centering pins "5"

(Figure 37) are close to the ear hole and then with the upper part of
the rods fix the head of the patient so that the pins enter the ear hole
(Figure 37).

5. Instruct the patient to close the eyes.

6. Press the ON button "20" of the laser centering device. A laser

beam will light up the FRANKFURT "1" plane reference (Figure 37).
The luminous beam of the Frankfurt plane (the plane that identifies a
line that ideally links the ear hole - the auditory meatus - with the
lower part of the orbital fossa) must be adjusted according to the
height of the patient. This adjustment is made using knob "5" (Figure
10) located on the side of the tubehead.

Once centering has been completed, press key "20" to switch


off the laser centering device.

NOTE:
The laser centering device remains lit until the button "20" is

pressed again or, upon completion of the alignment procedure, key

"23" is pressed to start exposure.

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7. If an "asymmetric" projection as been selected, the Soft Tissue Filter

(STF) will be automatically inserted; by pressing key "26" or

key "24" , the STF position can be changed to match the value

read on the graded scale "3", so to fit the patient’s profile.

NOTE:
The value relative to the soft tissues filter (STF) corresponds to the value
given on the graded scale located on the patient centering device in
cephalometry (see paragraph 6.9.3).

NOTE:
The graded scale of the nose rest serves only for making a latero-lateral
projection. For postero-anterior or antero-posterior projections, its use is
not necessary and so it must be placed in a parked position by rotating it
until it lies horizontal. Furthermore, for latter projections, the software
automatically moves the Soft Tissue Filter out-of-field to enable
exposures to be correctly made.

Legend

1 Frankfurt plane line


2 Nose rest
3 Graded scale for Soft
Tissues Filter
4 Ear centering device
5 Pins for ear centering device
6 Height adjustment knob for
cephalostat group (in low
position for L.L.
examinations)

Figure 37

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6.9.4 Making an exposure

WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the regulations in
force in the country where the machine is used.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 1.5 meters away
from the emission of the rays (see Figure 1 and Figure 2).

1. Verify once again that the exposure data are correct (see paragraph
6.9.2). Advise the patient to remain still and to keep his mouth closed
with the teeth touching throughout the duration of the exposure.

Press key "23" .

The collimator corresponding to the selected cassette will be placed in


position. Furthermore, if the type of exposure requires it, the soft
tissues filter will be positioned according to the value set by the
operator.
Check that the light unit ready for X-ray is ON.

NOTE:
To cancel this operation, press button "10" .

2. Press the X-ray button "30" for the entire duration of the exposure,
ensuring that the X-ray light 2 is also lit (if the unit is in view) and
that the X-ray signal acoustic sounds. The following message will be
displayed first:

S T A R T E X A M
P R E - H E A T I N G

and then (after 2 seconds), the following message will be displayed:

> X - R A Y <
x x k V x x m A x . x x s
x = the value defined by the settings

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NOTE:
If there is no cassette, the following message will be displayed:

C E P H
I N S E R T F I L M

NOTE:
If, during the preparation of the first cephalometric examination the
system detects a cassette which has not been replaced, the following
message will be displayed:

C E P H
R E M O V E F I L M

The examination will not be continued until a new cassette has been
inserted.

NOTE:
X-rays are emitted with a delay of two seconds from pressing the X-ray
button to allow the heating of the filament and the control of all set
parameters. Since the X-ray button is a "dead man" control, it must
be kept pressed until the end of the exposure.

3. Once the exposure is completed, the following message will be


displayed:

C E P H
R E M O V E F I L M

4. Remove the cassette. LED "23" lights up and the set cassette,

STF, kV, mA and seconds values relative to the exposure made will
be displayed.

NOTE:
If you try to perform a new exam before the cooling period has elapse (4
minutes), the following message will be displayed indicating the time to
wait before performing a new examination:

T U B E C O O L I N G
P L E A S E W A I T x x x s

This time enables the X-ray tube's anode to cool down.

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5. The cassette can now be opened in a dark room and the film
developed.

NOTE:
After every examination, clean the ear centering device and temple
support thoroughly.

NOTE:
If, during the exposure the patient moves or the operator realizes that the
parameters set are incorrect, the X-ray button "30" must be released
immediately, thus suspending emission of the X-rays.
The following message will be displayed:

E 5 6 1
P R E S S R E S E T

Press button "9" . The following message will be displayed:

C E P H
R E M O V E F I L M

The system now returns to the position for Ceph exam and the unit
starts the procedure for the new examination.

NOTE:
We recommend verifying that the system is still aligned correctly with the
patient (Frankfurt plane) via the laser centering devices.

NOTE:
No warning message will be given if the cassette is removed but the film
is not replaced, and another exposure is made. However, the film would
provide non-diagnostic results due to the double exposure.

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6.10 Messages on display


STRATO 2000 is fully controlled by a microprocessor which controls the
programming of the emission parameters and signals the various
conditions of the machine, the possible abnormalities and errors via
displayed messages.
The messages can be divided into two groups:
• operation messages: these messages tell the operator how to set up
the unit for the examination
• error messages: these messages are displayed when an error occurs.
There are three kinds of error messages as follows:

1- Messages prompted when the X-ray emission button is released by

the operator or by pressing key "9" . The message displayed

will be as follows

E x x x
P R E S S R E S E T
xxx = error message code number

Operations are reset by pressing key "9" .

2- Messages generated by a system error. In this case, the Technical


Service must be called.
Messages that require the intervention of the Technical Service are
displayed as follows:

E x x x
C A L L T E C H A S S .
xxx = error message code number

3- Messages related to H.F. board problems. If this occurs, switch off


the unit. Wait a few minutes for the capacitors of the relative circuit
to discharge and then switch the machine on again. If the problem
persists, call the Technical Service.

E x x x
S W I T C H P O W E R O F F
xxx = error message code number

Those messages requiring the intervention of the Technical Service


together with the relative verifications and actions are listed here
below.

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Motors movement

Code Error description


500 Unexpected limit switch activation, X- axis
501 Unexpected limit switch activation, Y-axis
502 Unexpected limit switch activation, rotation axis
503 Unexpected limit switch activation, cassette axis
504 Time-out motor zeroing
505 Time-out Y axis
506 Time-out R axis
508 Time-out X axis

Collimator 1

Code Error description


510 Primary collimator position 0 not found
Decoding error of primary collimator position (optical-
511
switches)
Maximum number of "seek retries" on primary
512
collimator exceeded
Motor in "time-out" during movement of primary
513
collimator
Limit switch not found during reset of primary
514
collimator
515 The "0" microswitch is always closed

Soft Tissues Filter

Code Error description


520 Soft Tissues Filter time-out
The movement of the Soft Tissues Filter stops at the
521
limit switch
Limit switch not found during reset of Soft Tissues
522
Filter

Collimator 2

Code Error description


530 Secondary collimator time-out

Cassette Holder

Code Error description


540 Cassette holder limit switch time-out not found
Cassette holder not in "PAN" position (cassette holder
541
open) or collision alarm (i.e. chin rest collision)
542 Collision of rotation arm with patient

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HF Board and Tubehead

Code Error description


550 "No power supply" alarm H.F. generator board
551 H.F. generator board "Overvoltage" alarm
552 H.F. generator board "Overload" alarm
553 H.F. generator board "Broken filament" alarm
554 H.F. generator board "No X-ray emission" alarm
555 "X-ray emission too long" alarm

Buttons

Code Error description


One or more keys are reported as pressed during the
560
switching on phase (see following table)
561 X-ray key released during X-rays examination
X-ray key short-circuited during start-up and/or
562
during examination programming
Remote X-ray button in short-circuit at switch ON or
563
during exam preparation

Memory Checksum

Code Error description


570 Checksum error on Flash EPROM
571 Writing error on Flash EPROM
572 Error during erase of Flash EPROM
573 Error during the verification phase of Flash EPROM
574 Unspecified error on Flash EPROM
575 Configuration data corrupted on Flash EPROM

Code Error description


600 Reset key pressed during movement
601 Hardware error protection key

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If error E560 is detected, the display will show which key has been
pressed in start-up phase, and the following message is shown:

E 5 6 0 ( x x x x x x x x )
C A L L T E C H A S S .
xxxxxxxx code number for error message 560

Code Description Key no.


(Figure 7)
00000001 Not used 21
00000002 PANORAMIC centring device switch 20
00000004 Arrow up 22
00000008 Arrow right 24
00000010 ENTER 23
00000020 Arrow left 26
00000040 Arrow down 25
00000100 Selection of Arch type (large, 13
normal, narrow)
00000200 Column key 28
00000800 Translateral TMJ selection 16
00001000 Size selection (small, medium, large) 12
00002000 Adult/Child selection 11
00004000 Selection CEPHALOMETRY 15
00008000 Selection IMPLANT 14
00010000 Column down 29
00080000 Selection PANORAMIC 17
00100000 Selection TMJ open/closed month 18
00200000 Selection TMJ BIAXIAL 19
00400000 Patient input 10
00800000 Reset 9
02000000 Increase by steps 3
04000000 Column up 27
08000000 kV selection 7
10000000 Exposure time selection 4
20000000 mA selection 5
40000000 Reduction by steps 6
80000000 Test 8

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6.11 Research and correction of possible defects in


dental radiographies

6.11.1 Faults due to a wrong positioning of the patient

Problem Description Solution


Too large and blurred The patient is not positioned Position the patient correctly, check
incisors. correctly, too far from the that he holds the bite with the
optimal focal plane. incisors on the fit notch and that the
bite holder rod is vertical.
Too small and blurred The patient is not positioned Position the patient correctly, check
incisors. correctly, he is too much that he holds the bite with the
beyond the optimal focal incisors on the fit notch and that the
plane. bite holder rod is vertical.
Radiography with The spine of the patient Check the alignment of the
blank central area. inhibits the passage of the Frankfurt plane, try to stretch the
X-ray since it’s too cervical part of the spine moving the
compressed. feet of the patient forward (see
paragraph 6.4.3 points 3/4/6/7)
and eventually correct the height of
the chin support.
Asymmetric dental The mid-sagittal line does Re-align the patient (see paragraph
arch. not correspond to the laser 6.4.3 point 6).
centring beam.
Upper apical area too The patient does not keep See paragraph 6.4.3 point 8.
dark. his lips shut and the tongue
is not against the palate.
Upper central apical The patient keeps his head Position the patient again and re-
area out of focus. rotated backwards align the Frankfurt plane.
(Frankfurt plane not
aligned).
The image is slanted in The patient head is slanted Position the patient again, correcting
comparison with the (not vertical). the position of the sagittal plane.
longitudinal axis of the
film and some
anatomical structures
are not symmetric.
The teeth on one side The head of the patient is Position the patient again correcting
are bigger than those rotated with respect to the the position of the sagittal plane and
on the other side. axis of the bite. controlling that the head does not
rotate.
CEPH exam: white Panoramic chin-rest still Perform the exam again removing
area in the lower part mounted. the PAN chin-rest.
of the film.

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6.11.2 Defects due to wrong data setting and to the dark room

Problem Description Solution


Under or overexposed The set kV value is not fit for Check the development system, or
film. the size of the patient. repeat the exam varying the kV
Possible error during value: see paragraph 6.4.4.
development. Should this solution fail, call the
Technical Service.
Completely black film. The film caught too much Verify the locking of the dark room
light or underwent an and do not keep new films near
unvoluntary radiation. radiogene sources or light sources.
Veiled film. This defect is checked Verify that the film is not expired
looking at the film edges not and that the storing indications
impressed by the radiation: given by the manufacturer have
if they are not perfectly been followed.
transparent, thus causing a Verify the working of the non-actinic
poor definition on all film. lamp in dark room.
Film with stripes. Being rapidly scratched Clean the screens with the antistatic
against its box the film liquid.
accumulated electrostatic
charges or the scintillating
screens have not been
treated with antistatic
liquid.
Film with blurred The film is not correctly Replace the cassette.
details and good pressed between the
contrast. screens.
Film completely white. Missing X-ray emission or Verify the emission of the X-rays by
wrong development. acoustical and luminous signal
(led 2), if the error persists, check
the development procedure. If no
solution can be found, call the
Technical Service.
Soft Tissues not or The STF value is not correct. Refer to paragraph 6.9.3 to adjust
poorly visible in L-L the position of the “STF”.
projection. A symmetric cassette size Select an asymmetrical cassette size
was selected. (which will enable the STF filter).

6.11.3 Defects on film due to the device

1. Should the film show non irradiated areas or be completely white,


this can mean that there is a defect in the alignment between X-ray
beams and film or a partial or total missing of irradiation; in any
case, call the Technical Service.

2. In case the soft tissue of the patient are not highlighted while
performing a cephalometry, in a latero-lateral, let the technician
verify the adjustment of the soft tissue filter.

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6.12 Analysis of the problems on the panoramic


examinations

The panoramic radiography is the examination of the maxillo-facial


region normally used to view the dental region inside the complete head
and sinuses-orbital complex. A good panoramic examination allows
distinguishing the main anatomical structures that are shown in the next
drawing:

Figure 38

Ref. Anatomic structure


1 Hard palat plane
2 Maxillary sinus
3 Mandible
4 Temporo mandibular condyle
5 Ascending ramus of the TMJ
6 Coronoid process
7 Mandibular canal
8 Foramen
9 Nasal anterior spine
10 Nose
11 Ioid bone (normally duplicated)

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6.12.1 Proper positioning of the patient

The proper positioning of the patient during the panoramic examination


is very important in order to get good quality radiography. This is due to
the fact that the shape of the focussed area, e.g. of the layer clearly
shown on the film, tends to follow the dental arch and has a non-
constant deepness.
The objects outside this focussed area will therefore appear blurred on
the resulting radiography.

1. The patient should not dress clothes that may interfere with the
X-ray beam, also to leave more space between the patient’s shoulders
and the rotating arm of the machine. Care must be taken in order to
avoid interference between the X-ray beam and the protective apron
worn by the patient.
2. Metal objects (neck chain, ear-ring) must be avoided; this objects not
only create radio-opaque images in their own position but also false
images projected in other parts of the radiography, so disturbing the
correct view of the anatomy.
3. The patient’s head must be lightly tilted downward in order to have
the Frankfurt plane horizontal. In this way, the hard palatal ceiling
will be projected slightly over the superior apex of anterior teeth. If
the patient has a low palatal ceiling, slightly increase the tilting
downward.
4. Align the middle sagittal plane with centre of the chin support,
normally indicated by the relevant light beam.
5. Check that the vertical light beam falls on the canine and lays
between the third and fourth teeth. This will insure that the apex of
the anterior teeth are positioned within the focussed area and
therefore will be properly reproduced on the radiography. Normally,
the panoramic equipment has a narrower focussed layer in the front
area, and therefore a proper positioning of the anterior teeth is of the
utmost importance.

Figure 39
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6. The patient must extend the spine; this is normally obtained by


asking the patient to step forward, making sure that all other
conditions are unchanged. If not properly extended, the spine will
cause the appearing of a lower exposed area (clearer) in the front part
of the film.
7. The patient’s tongue must be positioned against the palate, otherwise
the air between the tongue and the palate will create a lower
absorbance area which will result on the film as a darker area which
in turn will hide the apex of the superior incisor teeth.

The result of all the above listed actions will be radiography where all the
parts are properly exposed are well identifiable as in the schema of
Figure 40.

Figure 40

It must be noted that radiography is quite symmetrical, with the


ascending rami of temporo mandibular joints almost parallel. The
occlusal plane is shown slightly tilted upward, the palatal plane does not
overlap the apex of the upper arch and therefore allows a good sight of
the same.

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USER'S MANUAL
General instructions for use

6.12.1.1 Error due to a bad patient's positioning

• The film shows the anterior teeth with reduced magnification


and not well defined. The cervical spine is shown an evident
white shadow.
In addition, on the molar zone there are too much shadows,
disturbing the view.
The resulting film is similar to the schema shown on Figure 41.

Figure 41

Possible cause:
The patient is positioned too forward, e.g. the centring light beam
falls at the back as shown in the drawing, the anterior teeth will
result unfocussed and reduced.

Remedy:
Check the patient positioning by using the light beams and the
adjustment knob of the canine light beam.
If, after the correct patient’s positioning, the problem still remain,
check the alignment of the centering laser lights, simply lighting on
the beams and verifying its positioning. The mid sagittal line must lay
on the center of chin rest while the canine one has to lay on the
terminal part of the bite block.

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General instructions for use

• Anterior teeth are enlarged and blurred


The Figure 42 depicts the resulting film.

Figure 42

Possible cause:
In the case the patient is positioned too backward, e.g. the centring
light beam falls at the beginning of the anterior teeth, as shown in
the drawing.

Remedy:
Check the patient positioning by using the light beams and the
adjustment knob of the canine light beam as above described.

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USER'S MANUAL
General instructions for use

• Part of the image is enlarged while the other one is reduced

The schema described on Figure 43 the film obtained; it is possible to


observe that one part of the radiography is blurred and enlarged,
while the other one is reduced and seems to be on focus; the two
condiles are at the same height on the film.

Figure 43

Possible cause:
This effect can be due to two different causes.
In the first one, the median-sagittal plane is not
aligned with the relevant centring light beam, which
falls at the centre of the chin support.
In the second case instead, the centre of the median-
sagittal plane matched the centre of the chin support,
but the patient’s head is rotated.
In both cases, one side is closer to the film plane than the other, thus
resulting in a different magnification of the two sides; the part more
distant from the film will be more magnified while the part closer to
the film plane will result smaller. This error in positioning the patient
will result in a radiography as shown in the next drawing: the right-
most area of the image shows a bigger magnification that can be
noticed either on the teeth and on the ascending rami of the TMJ.

Remedy:
Check the positioning of the median-sagittal plane by using the
relevant centring light beam.
Check also the position of the middle sagittal beam; lighted, it must
fall down on the center of the chin rest and also on the center of the
byte.

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General instructions for use

A more accurate check is performed using the special rounded tool


and making a film; the dimensions measured on the obtained film
must match those reported on the service manual, with a ± 1 mm
tolerance.
In case these dimensions are not respected, perform a calibration of
the X and Rotation axis; particularly X axis has to be checked if the
mid sagittal beam is off center, while the rotation must be checked if
the two measures (center to right against center to left) are different.
In case of rotation adjustment, the X axis position must be always
cheched; this can be accomplished using the program for Y axis and
measuring the distance between , with the beam lighted , pressing

the Test button to perform a rotation of 180°, looking at the

intersection of the laser beam with the reference line of the flat
template. The intersection point must not drift more than 2 mm,
measure this drift.
If this does not happens, means that the sigittal laser is not aligned
with the rotation center, so it must be adjusted; to perform it, remove
the upper cover of the STRATO 2000.

Still in the Y axis position, using the and/or , moves

the X axis half of the above measure and on the opposite direction of
the drift; save the new position of the X-axis. At this point, the mid
sagittal laser will not be in the correct position and it must be aligned
using the four screws of the laser support; this operation must be
performed in such a way that all the laser beam falls on the reference
line.

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USER'S MANUAL
General instructions for use

• The image shows TMJ at different height

This fact is described in Figure 44.

Figure 44

Possible cause:
The mid sagittal plane is not vertical. This can be a patient’s
problem, but if the defect is always present, check the laser beam.

Remedy:
Verify that the laser beam is vertical; this check can be performed
very quicly using the laser beam and verifying that falls on the center
of the chin support; remove the chin support itself and check that
the beam falls on the center of the holes used to fix the chin itself.
If not, a possible cause can be due to a non perfect horizontally of the
chin arm, that must be adjusted using the relevant screws.

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General instructions for use

• The image shows undulated teeth rows

As can be seen on Figure 45, the upper teeth are magnified and
unfocussed, with the shadow of the hard palate positioned over the
superior apex. The temporo-mandibular joints are exposed outward,
with lines divergent upward. In some cases, the condile vertex might
not appear on the image.

Figure 45

Possible cause:
Patient’s head tilted upward.
A Frankfurt plane too tilted upward produces different anomalies
that may also appear contemporaneously. A chin support plane too
high during the patient positioning or when extending the spine may
generate this mistake. In this condition, the rear side of the patient’s
head may also interfere with rotating arm of the panoramic
equipment.

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USER'S MANUAL
General instructions for use

• The radiographic image shows the teeth row too curved


upward with the lower incisor non-focussed

Additional defects shown on Figure 46, the temporo-mandibular


joints will be positioned too high with lines converging upward. In
some cases the upper condile might not be visible in the image.

Figure 46

Possible cause:
Patient’s head tilted downward, as on the aside schema.

Remedy:
Check the positioning of the patient by aligning it with the help of the
corresponding light beam.

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General instructions for use

NOTE:
In some cases the positioning of the Frankfurt plane too tilted downward
produces a correct image of the lower incisors, but the projection of the
palate falls on the lower teeth apex, as shown on Figure 47.

Figure 47

In this case, a light tilting downward of the Frankfurt plane causes the
palate to be projected over and too far from the root of the teeth of the
maxilla arch, without distortion of the incisor teeth, as on Figure 48.

Figure 48

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USER'S MANUAL
General instructions for use

6.12.1.2 Images with artefacts

• Radiographs that show images with soft tissues or artefacts

The radiographs may show anatomical parts of the soft tissues or


show radiographic artefacts.
Normally the soft tissues might be more or less present depending on
the patient positioning, while the presence of artefacts is strictly
dependent on the presence of foreign objects on the trajectory of the
X-ray beam.
Next figure shows these cases; please consider that all structures
have a bilateral duplicate.

Figure 49

Where different references are described among with the


cause/remedy, if any.

Soft tissue Description Artifacts Description

2 Hear soft tissue 1 Dark shadows due to


the air gap between
tongue and palat
3 Nose soft tissue 4 Spine column
7 Epiglottis 5 Leaded apron too high

The part identified with "6" in Figure 49 represents the image of the
controlateral mandible (the other side of the mandible). That
therefore results as a clearer area overlapped to the real image. Very
often the resulting darker area in the bottom corner is noticed and is
considered as an artefact of the radiological image.

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General instructions for use

This is not true, because it is derived from the projection


geometry used to obtain the panoramic image. The effect can be
more evident if the film in underexposed due to wrong
radiological parameters.

With reference to the previous Figure 49, let’s analyse the cause and
remedy.

• Wrong positioning of the spine

In the case the image shows a too clear and unfocussed area in the
central portion (see point "4" - Figure 49), this is probably caused by
the wrong position of the spine that has not been properly extended
by the patient. In this case, the spine absorbs a too big quantity of
radiation that therefore causes the image to be too clear. This
lightness can be noticed especially in the lower part of the film, while
it’s normally less visible on the upper part of the film.

Remedy:
Ask the patient to step forward thus extending the spine, in order to
reduce X-ray absorption.

• Shadows or bright artefacts

The most common cause for the presence of these artefacts is the
presence of metal objects worn by the patient (ear-rings, necklace).
The necklace worn on the neck of the patient can normally result in a
radio-opaque arch positioned in the chin area. This arch normally
overlaps the chin itself and the shadow of the spine, disturbing the
diagnosis of possible problems in the chin area and in the area of the
superior apex.
The ear-rings instead creates real images in the proper position and
shadow images projected in the contro-lateral area, thus hiding
possible problems or generating bright areas within the paranasal
sinuses.
In some cases, that may depend either on the trajectory of the
panoramic machine or on the position of the metal objects, they can
generate up to three images (one real ad two shadows), thus further
disturbing the correct diagnosis.
This situation may occur especially if the patient has large prothesis
or metal cures and if it is associated to a positioning error, that
projects the shadow of the metal part on wide area of the image.

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General instructions for use

• Non-exposed area in the lower-central part of the image

If the problem appears as shown in point "5" of the previous Figure


49, it indicates that there has been interference between the leaded
apron worn by the patient and the X-ray beam.

Remedy:
Properly position the leaded apron (it must be worn well tight to the
shoulder and neck of the patient) then carry out a new examination.

• The teeth rows are overexposed

As already described, if the tongue is not positioned against the


palate during the exposure, it will create an air chamber between the
tongue and the palate; this air gap creates a less absorbing area that
overlaps the teeth, often in the apex area. This area is identified with
reference "1" in Figure 49.

Remedy:
Ask the patient to position the tongue against the palate during the
exposure.

• Presence of bright spots or rows

If these artefacts are always in the same position on the film, they are
probably generated by dirty or damaged intensifying screen.

Remedy:
Check and clean/replace the screen.

• Film with images of the cassette locking device

The cassette has been fit into the machine on the wrong side. As
general rule, the film is underexposed due to the presence of the
secondary lead shielding.

Remedy:
Repeat the examination by properly fitting the cassette into the
machine.

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General instructions for use

• Damaged films

– Presence of scratches or residuals.

Possible cause:
The problems are probably due to the developer (ruler worn out
or dirty).

Remedy:
Check the developing machine, looking to scratches on ruler;
replace the developing liquids.

– The film shows an unexposed area 10x50mm wide.

Possible cause:
In this case a cassette with patient identification window has
been used.

Remedy:
Use a cassette without the identification label.

• The film shows spots similar to lightning

Possible cause:
They might be caused by electrostatic charges produced by the
intensifying screens or the scratching of the intensifying screens
against the film.

Remedy:
Check the humidity of the dark room and place the film into the
cassette without scratching it against the intensifying screen.

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General instructions for use

6.12.1.3 Incorrect film contrast and density

• Images too clear

Normally this indicates that the exposure parameters are too low
with respect to the patient size. Another possible cause is a wrong
film development process, especially if a manual developer is used.
Another possibility is the misalignment of the X-ray beam with
respect to the alignement of the two collimators.

Remedy:
– Increase the exposure parameters
– Check the development process (liquids, temperatures, duration,
etc.)
– Check that the panoramic cassette holder is fully closed in
panoramic position (check that it is really fully pushed against
the mechanical stop)

• Images too dark

Possible cause:
Exposure parameters too high with respect to the patient size.

Remedy:
– Decrease the exposure parameters
– Check that the development process (liquids, temperatures,
duration, etc.).

• Image without contrast (flat image)

In the case the film has a poor contrast (flat image), there can be
different causes.

Possible cause Remedy

kV value too high Decrease the kV value


Improper film-screen combination Check film-screen compatibility
Edge of the film (non-exposed area) Check the film (expiration date,
blurred storage)

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General instructions for use

• Blurred film

Possible cause:
This problem is normally coupled to the presence of poor brightness
in the areas with metal parts.
This may indicate a problem of the dark room (the film has been
exposed to the light during the handling), or to the wrong storage of
the film package or, the films themselves are expired.
Also the film package has been unintentionally exposed to X-ray.

Remedy:
Avoid the above conditions.

• One side of the film is overexposed

Possible cause Remedy

The film was already exposed Check the film package, if exposed
by mistake or casually, replace it
with a new one; take care of not
expose it to X-ray or light
Light filters through the dark room Check for the presence of light in the
or in the cassette dark room and eliminate it. Use
special lamps in the dark room
The cassette has not been properly Close correctly the cassette before
closed exiting from the dark room with a
new film

(Rev. 0) 155 STRATO 2000 (120V)


USER'S MANUAL
General instructions for use

6.13 Storing of automatical exposure parameters


At the end of mechanical installation and functional check the stored
exposure parameters can be modified depending on the operator needs
such as the combinations between screens and films or the need to get
less or more contrasted (exposed) images.

6.13.1 Exposure parameter

To modify the automatic exposure parameters, please follow the indicated


procedure:

1. Select the exam, the type of patient and the size to be modified.

2. According to the parameter to be modified press "7" and/or

"5" and/or "6" (the latter just for Cephalometric

function). On the display, on the left of the selected parameter value,


a reference character ">" will be displayed

NOTE:
The pressure of one of the three parameters setting keys will cause the
de-activation of the patient size LED and the blinking of the patient type
and function/examination LED's. This LED's will be reactivated only
when storing parameters (paragraph 6.13.3).

3. Press "3" or "6" to set the value to store.

STRATO 2000 (120V) 156 (Rev. 0)


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General instructions for use

6.13.2 Soft tissue filter

It is possible to set the default value of the Soft Tissue Filter in function
of patient type (Adult/Child) and the patient size (small, medium, large).

NOTE:
The value of Soft Tissue Filter is stored for all Asymmetric projections.
For the symmetrical projections instead, the default position of the STF is
out (the display shows OUT).

6.13.3 Storing parameters

To store the set value, press the key "28" e "23" , at the

same time, the display will show the following message:

U P D A T E C H A N G E S ?
E N T E R = Y R E S E T = N

press key "23" to confirm, the LED's will lit again, or the key

"9" to cancel the setting; in this case the LED's blink and the

display still shows the same value.

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General instructions for use

6.13.4 Table of pre-set anatomic parameters

PANORAMIC TMJ open/close mouth


Adult Child Adult Child

70 kV 66 kV 70 kV 60 kV
Thin Thin
10 mA 8 mA 10 mA 10 mA

74 kV 68 kV 74 kV 66 kV
Normal Normal
10 mA 8 mA 10 mA 10 mA

76 kV 70 kV 78 kV 70 kV
Robust Robust
10 mA 9 mA 10 mA 10 mA

TMJ BIAXIAL CEPHALOMETRY (L.L)


Adult Child Adulto Bambino

70 kV 60 kV 74 kV 72 kV
12 mA 11 mA
Thin Thin
10 mA 10 mA 0.8 s 0.9 s
83 FPM 83 FPM

74 kV 66 kV 76 KV 74 kV
12 mA 11 mA
Normal Normal
10 mA 10 mA 0.8 s 0.9 s
83 FPM 83 FPM

78 kV 72 kV 78 KV 76 kV
12 mA 12 mA
Robust Robust
10 mA 10 mA 0.8 s 0.7 s
83 FPM 83 FPM

STRATO 2000 (120V) 158 (Rev. 0)


USER'S MANUAL
Maintenance

7. MAINTENANCE
This unit, exactly as all other electrical appliances, requires to be
correctly employed and also serviced and controlled at regular intervals.
This precaution ensures a safe and efficient performance.

The periodical maintenance consists in periodical checks performed


either by the operator himself and/or by a qualified technician.

The operator can control the following items:


• check that the plates are in order and well fixed
• check possible oil leaks from the tubehead
• check that the button cable does not show breaking or wearing signs
• check that the unit is not damaged externally as to compromise the
safety of protection from radiations.

WARNING:
In case the operator would detect faults or abnormalities, he must
immediately call the Technical Service.

(Rev. 0) 159 STRATO 2000 (120V)


USER'S MANUAL
Maintenance

MAINTENANCE LOG-BOOK

Installation: Date ........... Technician ....................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

Maintenance: Date ............. Technician ....................

Cause .............................................

STRATO 2000 (120V) 160 (Rev. 0)


Cod. 6909903703_Rev.0 0434

Dent-X
250 Clearbrook Rd.
Elmsford, NY 10523 - USA
Tel. (914) 592-6100
Fax (914) 592-6148
www.Dent-X.com

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