YOSHIDA X-era Smart User manual


This “Operation Manual” describes information on
how to operate “X-era Smart”, a digital panoramic
tomographic X-ray diagnostic apparatus for dental
use, arm-type X-ray CT diagnostic equipment and
precautions for use.
• To avoid any unexpected accident, failure, or
damage to the system, read this “Operation
Manual” prior to system installation.
• Be sure to keep this manual after having read
through it.
Operation Manual

1
Operation Manual
Introduction
Although the equipment has undergone strict quality control and inspections before shipment,
pleasecontactyourdealerifyoundanyfailureordefectofthedevice.
• A symbol *used in this manual alerts the user to possible dangers to the human body or
possible damage to the equipment. To avoid these unexpected accidents, read carefully
and adhere to the instructions following the symbol.
• Be sure to read through the manual prior to use to take full advantage of the equipment
and use it effectively for many years to come. To avoid any unexpected accident, failure,
or damage, once you have read the manual, keep it in a prominent place near the
equipment.
• If you have any question or opinion about the manual, feel free to contact your dealer.
Should any nonconsecutive numbering or page missing is found, the defective manual will
be replaced with a new one.
• Reproduction or reprint of part or all of the manual without prior written permission is
strictly prohibited.
• Modicationsmaybemadetothemanualatanytimewithoutpriornotice.
Disclaimer
We will not be liable for any failure, damage, and condition occurring in X-era Smart
attributable to:
• Installation, relocation, maintenance, and/or repair by us any other subcontractor than
those we nominated.
• Any other product than those we delivered.
• Maintenance and/or repair using any other repair parts than those we designated.
• Negligence of precautions/instructions and the correct operating procedure described in
the manual.
• Ambient environment departing from the operating conditions (power supply, installation
environment,etc.)fortheequipmentdenedinthemanual.
• Naturaldisasterssuchasre,earthquake,ood,andlighting.

2Operation Manual
Table of Contents
Introduction............................................................................................................................... 1
Safety Precautions ................................................................................................................... 7
Precautions for Use.................................................................................................................. 8
Required Maintenance and Inspection................................................................................... 11
Durable Period........................................................................................................................ 11
Guaranteed Supply of Replacement Perfomance Parts ........................................................ 11
Actions to be taken in case of an Accident............................................................................. 11
Signage used in the Manual................................................................................................... 12
EMC Conformity Symbol ........................................................................................................ 12
Storage and Usage Environment Precautions ....................................................................... 16
Precautions for Installation and Relocation ............................................................................ 17
1 Before Using this Product 19
1.1 Intended Use................................................................................................................. 19
1.2 Main Label..................................................................................................................... 19
1.3 Names and Functions of Units and Their Parts ............................................................ 23
1.3.1 Main body ..........................................................................................................................23
1.3.2 Names and functions of control panel switches and indicators (1) ....................................26
1.3.3 Names and functions of control panel switches and indicators (2) ....................................29
1.3.4 Names and functions of hand-switch box indicators and switches ....................................30
1.3.5 Head support unit...............................................................................................................31
1.3.6 Positioning beams..............................................................................................................32
1.3.7 Sensor unit (detachable)....................................................................................................34
1.3.8 Cephalometric unit (*) ........................................................................................................35
1.3.9 Positioning beam allocation ...............................................................................................37
1.3.10 Sensor unit (movable) (**)..................................................................................................38
1.3.11 Headxatorfor3Dimageacquisition(**)...........................................................................39
1.4 Materials of Applied Parts ............................................................................................. 41
1.5 Principle of Operation.................................................................................................... 42
1.5.1 X-ray generating mechanism .............................................................................................42
1.5.2 Operating principle ............................................................................................................42
1.5.3 Principle of Radiographic ...................................................................................................43
1.6 Radiographic Functions ................................................................................................ 44
1.6.1 Functions of exposure modes............................................................................................44
1.6.2 Selecting Exposure status ................................................................................................47
1.6.3 Names of arm unit positions ..............................................................................................48

3
Operation Manual
1.7 Cooling Time ................................................................................................................. 50
1.8 Software ........................................................................................................................ 51
2 Directions for Use 52
2.1 Pre/post-operational Procedures .................................................................................. 52
2.2 Emergency Stop............................................................................................................ 53
2.3 Procedure of Panoramic and TMJ Radiography ........................................................... 54
2.3.1 Turning the power switch on ..............................................................................................54
2.3.2 Flow of Image Acquisition ..................................................................................................55
2.3.3 Setting the Exposure mode................................................................................................56
2.3.4 Seating the patient inside the equipment...........................................................................62
2.3.5 Patient Positioning in Panoramic mode .............................................................................65
2.3.6 Patient Positioning in TMJ mode .......................................................................................71
2.3.7 X-ray Exposure ..................................................................................................................74
2.3.8 Patient's Exit ......................................................................................................................77
2.3.9 Image Transfer...................................................................................................................77
2.3.10 Turning Off the Equipment.................................................................................................78
2.4 Procedures of Cephalometric and Carpus Radiography............................................... 79
2.4.1 Turning the power switch on ..............................................................................................79
2.4.2 Flow of Image Acquisition ..................................................................................................79
2.4.3 Setting the Exposure Mode................................................................................................79
2.4.4 Patient's entry and Positioning...........................................................................................80
2.4.5 X-Ray Exposure.................................................................................................................83
2.4.6 Patient’s Exit ......................................................................................................................85
2.4.7 Image Transfer...................................................................................................................85
2.4.8 Turning Off the Equipment.................................................................................................86
2.5 Procedure of 3D Radiography....................................................................................... 87
2.5.1 About 3D image acquisition ...............................................................................................87
2.5.2 Turning the power switch on ..............................................................................................90
2.5.3 Openingng the image formulating window of Image Creator.............................................90
2.5.4 Setting the Exposure Mode................................................................................................90
2.5.5 Seating and positioning the patient....................................................................................90
2.5.6 X-ray Exposure ................................................................................................................100
2.5.7 Patient's Exit ....................................................................................................................102
2.5.8 Detachingtheheadxatorfor3Dimageacquisition .......................................................102
2.5.9 Image Transfer.................................................................................................................102
2.5.10 Turning Off the Equipment...............................................................................................103

4Operation Manual
3 Directions for Use of X-era Smart ControlManager 104
3.1 Starting up X-era Smart ControlManager.................................................................... 105
3.2 Descriptions of Unit Information Monitor ..................................................................... 105
3.3 Descriptions of “Setup” Screen ................................................................................... 105
3.4 ConrmingProgramVersions..................................................................................... 107
3.5 ConguringaCommunicationPort(s)........................................................................ 108
4 Directions for Use of Image Creator 110
4.1 About the Patient Selection Screen ............................................................................ 110
4.2 About the Patient Registration Screen ........................................................................ 110
4.3 About the Launcher Screen ........................................................................................ 111
4.4 How to use the Image Construction Screen................................................................ 112
4.5 Image Data.................................................................................................................. 114
4.6 Saving and Loading of Acquired Data (RAW Data) .................................................... 114
4.7 Tomographic Adjustment ............................................................................................ 115
4.8 Display Adjustment ..................................................................................................... 117
4.9 Image Export............................................................................................................... 118
5 User Program Mode 119
6 Trouble Shooting 122
6.1 Troubles and Their Corrective Measures.................................................................... 122
6.1.1 Troubles with image acquisition.......................................................................................122
6.1.2 Troubles associated error messages displayed on the screen........................................125
6.2 Contact Procedures at the Time of Failure ................................................................. 126
7 Maintenance Services 127
7.1 Cleaning ...................................................................................................................... 127
7.2 Periodical Checks ....................................................................................................... 128
7.3 Periodical Check Services .......................................................................................... 129
7.3.1 Outsourcing the Periodical check services ......................................................................129
7.3.2 Archiving records on Periodical check .............................................................................129
7.4 Performing Regular Check Services ........................................................................... 130

5
Operation Manual
8 Disposal 132
9 Patient Positioning Part 133
10 List of Periodical Replacement Parts and
Consumable Replacement Parts 134
10.1 Periodical Replacement Parts..................................................................................... 134
10.2 Consumable Replacement Parts ................................................................................ 134
11MainSpecication 135
11.1 Specication................................................................................................................ 135
11.2 FilterSpecications..................................................................................................... 139
11.3 Dimensional Drawing .................................................................................................. 140
11.3.1 Standing position wall-mount: Panoramic type ................................................................140
11.3.2 Standing position wall-mount short type: Panoramic type ...............................................141
11.3.3 Standing position wall-mount long type: Panoramic type ................................................142
11.3.4 Standing position wall-mount: 3D type.............................................................................143
11.3.5 Standing position wall-mount short type: 3D type............................................................144
11.3.6 Standing position wall-mount long type: 3D type .............................................................145
11.3.7 Standing position base-mount (with an optional base): Panoramic type .........................146
11.3.8 Standing position base-mount short type (with an optional base): Panoramic type ........147
11.3.9 Standing position base-mount long type (with an optional base): Panoramic type..........148
11.3.10 Standing position base-mount (with an optional base):3D type.......................................149
11.3.11 Standing position base-mount short type (with an optional base): 3D type .....................150
11.3.12 Standing position base-mount long type (with an optional base): 3D type ......................151
11.3.13 Standing position base-mount (with an optional wide base): Panoramic type.................152
11.3.14 Standing position base-mount short type (with an optional wide base): Panoramic type 153
11.3.15 Standing position base-mount long type (with an optional wide base): Panoramic type .154
11.3.16 Standing position base-mount (with an optional wide base): 3D type .............................155
11.3.17 Standing position base-mount short type (with an optional wide base):3D type..............156
11.3.18 Standing position base-mount long type (with an optional wide base):3D type...............157
11.3.19 Standing position wall-mount: Cephalometic type ...........................................................158
11.3.20 Standing position wall-mount short type: Cephalometic type ..........................................159
11.3.21 Standing position wall-mount long type: Cephalometic type............................................160
11.3.22 Standing position wall-mount: 3D , Cephalometic type....................................................161

6Operation Manual
11.3.23 Standing position wall-mount short type: 3D , Cephalometic type...................................162
11.3.24 Standing position wall-mount long type: 3D , Cephalometic type ....................................163
11.3.25 Standing position base-mount (with an optional base): Cephalometic type ....................164
11.3.26 Standing position base-mount short type (with an optional base): Cephalometic type....165
11.3.27 Standing position base-mount long type (with an optional base):Cephalometic type......166
11.3.28 Standing position base-mount (with an optional base): 3D , Cephalometic type.............167
11.3.29 Standing position base-mount short type (with an optionabase): 3D , Cephalometic type .... 168
11.3.30 Standing position base-mount long type (with an optional base): 3D , Cephalometic type.... 169
11.3.31 Standing position base-mount (with an optional wide base): Cephalometic type ............170
11.3.32 Standing position base-mount short type (with an optional wide base): Cephalometic type . 171
11.3.33 Standing position base-mount long type (with an optional wide base): Cephalometic type... 172
11.3.34 Standing position base-mount (with an optional wide base): 3D , Cephalometic type ...173
11.3.35 Standing position base-mount short type (with an optional wide base): 3D , Cephalometic type ....174
11.3.36 Standing position base-mount long type (with an optional wide base): 3D , Cephalometic type .....175
11.4 Circuit Block Diagram.................................................................................................. 176
11.5 Circuit Block Diagram (Cephalometic Type) ............................................................... 177
11.6 Circuit Block Diagram (for Equipment with 3D Function) ............................................ 178
11.7 Circuit Block Diagram (for Equipment with 3D Function and Cephalometric)............. 179
11.8 Spatial Resolution (MTF) ............................................................................................ 180
11.9 Anode Cooling Curve and Heat Content of X-ray Tube Head
Assembly..................................................................................................................... 181
11.10 Stray Radiation Information ...................................................................................... 182
11.10.1 Dimensions of the phantom used ....................................................................................182
11.10.2 How To Test.....................................................................................................................182
11.10.3 Stray radiation dose of X-era Smart in 3D oral mode ......................................................183
11.10.4 Stray radiation dose of X-era Smart in 3D dental mode ..................................................184
11.10.5 Stray radiation dose of X-era Smart in 3D oral mode with Cephalometric.......................185
11.10.6 Stray radiation dose of X-era Smart in 3D dental mode with Cephalometric...................186
12 QA (Quality Assurance) 187
12.1 Structure of the Installation Phantom .......................................................................... 187
12.2 3D QA Phantom Structure .......................................................................................... 187
12.3 QA Procedure (Panorama) ......................................................................................... 188
12.4 QA Procedure (3D) ..................................................................................................... 190

7
Operation Manual
Safety Precautions
Meaning of symbols
A symbol *and its variations used in the manual and attached to the equipment have
the meanings described below. To avoid any possible danger, be sure to adhere to the
instructions following these symbols.
*: Informs the user of any general caution, warning, or danger.
*Danger : Alertstheusertoadirectdanger,whichmayleadtore,serious
damage to the equipment and its surrounding proprietary (e.g.totally lost
machine), serious personal injury or death.
*Warning : Thisisusedtoindicateanindirectdangerthatcouldcauseresevere
porperty damage (e.g.complete failute of the equipment), serious
personal injury or death.
Following is an example of indirect danger.
Example: Ignoring a warning label and opening a cover and touching a
high-voltage terminal could result in death.
*Caution : Alerts the user to a risk of any accident, which may lead to loss of
computer data, partially destroyed equipment or mild to moderate
injuries.

8Operation Manual
Precautions for Use
*Warning
CARELESS OR IMPROPER USE OF X-RAY EQUIPMENT CAN BE EXTREMELY
HAZARDOUS.
1. This product is only to be used in the radiaton control area.
2. During image acquisition or positioning, the rotation arm unit will rotate around the
patient. To avoid the accident, look out for patient's safety at all time. In case of any
dangerous situation occurs, immediately stop the operation.
3. During image acquisition or positioning, the rotating arm unit will rotate around the
patient. To avoid the accident, ask the patient to refrain from moving until rotating arm
unit stops the movement.
4. Ensure that the power switch is OFF (O) if you do not intend to operate the equipment
for a long period.
5. Modicationofthedeviceisprohibited.Donotremoveanycoversorcableson
system.
6. Electromagnetic wave
This medical device could malfunction due to electromagnetic waves. Instruct persons
in your fascility to turn off the power of electronic devices such as mobile phones,
transceivers, radio control transmitters, etc.
7. Be sure to plug a medical ground cable into a ground outlet prior to use of X-era
Smart. Do not plug the cable into any other kind of outlet than that for exclusive use.
8. Donotconnectanydevicesotherthanthespeciedforthisequipment.Also,donot
installsoftwareotherthanthespeciedtothePCconnectedtothesystem.
9. Donotinstallthelmprocessorinthesameroomastheequipment.Thegas
generatedbythelmprocessormaycorrodetheequipmentandcauseserious
damage.
10. Do not look directly into the positioning beam. The power output (Class 2) is at the
level which adverse effect on the eyes can be avoided by blinking. However caution
should be taken for maximum safety.
11. Do not apply any heavy load or shock on the equipment, e.g. suspending from the chin
rest or sliding mechanism, otherwise the equipment may be damaged.
12. Be sure to keep the infants and small children away from the equipment unless
required for radiographic purpose.
13. Do not give high impact or excessive external load to this product. It may cause
malfunction.