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.

9
Operation Manual
*Warning
14. Do not hang down from or apply force on the Cephalometric unit (including the
Cephalometric-arm). The equipment may fall or be damaged.
15. Also, do not allow children to hang on or lean on to the Cephalometric unit (including
the Cephalometric-arm).
16. User or operator of the device is responsible to follow the relevant local law, regulation
and standards regarding the usage, the installation and the maintenance.
*Caution
1. Onlytrainedandqualiedpersonnelshouldtakeradiographicphotos.Theuseofthis
equipmentbyunqualiedpersonnelisprohibitedbylaw.
2. Usually, turning the power switch on moves the arm unit automatically to the patient
positioning point. To avoid damage to surrounding physical assets, do not place
anything within a movable range of the arm unit.
3. Be sure to press the correct switches, such as the Up and Down switches, during
positioning, otherwise the patient may be injured.
4. Be sure to carefully open or close the head support by gripping its base without
applying excessive force, otherwise the patient may be injured.
5. Do not wipe off the plastic or coated surfaces of the equipment with cloth dampened
with any solution containing chemicals, e.g. paint thinner, benzene, and alcohol.
It may cause discloration, malfunction or accident.
6. Carefully read "Safety Precautions in Using Medical Electric Equipment".
7. Ask the patient to wear an X-ray protective apron and the child patient to wear both the
X-ray protective apron and a thyroid shields.
8. Avoid taking X-ray of pregnant patient or patient with possibility of pregnancy.
9. Do not use any other accessories other than designated by YOSHIDA.
10. Keep the patient away from the equipment until the arm unit of the equipment has
returned to its start position. Patient may get caught by the arm unit and cause injury.
11. Be careful not to direct the positioning laser beam into patient’s eyes. And also, advise
the patient not to look directly into the beam.
12. To ensure proper function of the equipment, operate the equipment only under the
speciedconditiondenedin"11.1Specication".
13. Take great care when turning on the heater in the X-ray room. A sudden temparature
rise in the cold X-ray room may cause dew condensation, leading to malfuction of the
equipment.

10 Operation Manual
*Caution
14. To minimize the X-ray dose irradiated on the patient, be sure to position the patient
correctly prior to image acquisition.
15. To prevent the patient from infection, always use a new bite block for each patient and
wipe it with alcohol-dempened cotton prior to use.
16. Correctly connect the PC protective earth terminal to ground.
17. Do not rotate the arm unit manually, as the patient body may be caught by the arm unit
or a failure may occur in the equipment.
18. Once the arm unit is positioned, be sure to return the positioning mirror to its original
position.
19. Becarefulnottogetyourngerscaughtintheequipmentduringtheoperation,such
as rotating, opening and closing, moving back and forth, of the ear rod and nose
support of the Cephalometric unit.
20. Do not touch the Sensor unit and the Second Slit unit while the Cephalometric Sensor
isoperating.Itisdangerousasyourngersorhandsmaygetcaughtandcause
injured.
21. Do not apply force to the Sensor unit. It may cause failure in the equipment.
22. Be sure to open or close the ear rod of the Cephalometric unit by its knob without
applying excessive force. Otherwise the patient may be injured.
23. Be sure to connect the additional protective earth conductor of the equipment.
24. Beware not to touch the equipment while the movable 3D sensor is in motion. The
ngerorhandmightgetcaughtandinjured.
25. Look out for the safety of the patient when moving the nose support of the
Cephalometric unit up, down, back or forth.
26. Advise the patient to stay still while an image is being acquired. If the patient moves,
it causes image blurring and degrades the image quality.Especially for 3D oral image
acquisition, advise the patient to stay still until the whole process of the acquisition is
completed.
27. Setupthemonitorwhereisnotaffectedbythereectionoflightusedinsideoroutside
the room and ensure you get the most suitable viewing condition and quality of the
image.
28. Do not operate this equipment in case of earthquake occurrence. After an earthquake,
check to see if the equipment operates properly to ensure the safety of the patient.
29. DonotplaceanyobjectsinsidetheX-rayeldoftheequipment.
30. Whenattachinganddetachingthesensor,rmlyholditbytheknobandmakesure
you do not drop it. Dropping the sensor may cause failure of the equipment.
31. The sensor unit is equipped with a shock sensor. The shock sensor records any
excessive impact incurred, such as when the equipment falls down, and the equipment
will not qualify as being warrantable. Exercise caution in handling the equipment.

11
Operation Manual
Required Maintenance and Inspection
Maintenance and inspection are needed to ensure safe use of the equipment.
Durable Period
The usable life is 10 years from the date of manufacture as long as the equipment is properly
maintained and inspected. * Based on Company data.
Guaranteed Supply of Replacement
Perfomance Parts
Supply of the replacement performance parts for this product (parts required to maintain
the function of the product) is guaranteed by the Company for 10 years from the date of
manufacture.
Actions to be taken in case of an Accident
1. In the event an accident occurs, immediately stop the equipment by pressing the
emergency button and ensure the safety of the persons involved in the accident.
2. Provideappropriaterstaidasrequiredbytheaccidentconditions.
3. If necessary, turn off the power of the computer and then turn off the equipment’s
scanner switch and system main switch.
4. Immediately contact the dealer where the equipment was purchased.
5. Use the contact information provided at the end of this manual.
*Warning
• Never use the equipment until the measure for preventing from possible dangers have
betakenandithasbeenconrmedthatsafetyisensuredinthedentalofce.

12 Operation Manual
Signage used in the Manual
The following signage is used throughout the manual.
NOTE : Provides general information on operations independent of safety precautions.
Suppl. : Provides supplementary information on operations and functions independent of
safety precautions.
See also :Indicates the title to be quoted or page.
EMC Conformity Symbol
• Complied Standard Number and Publication Year: IEC 60601-1-2:2001, A1:2004
• Compliance Statement: This product complies with EMC Standard IEC 60601-1-2: 2001,
A1: 2004
• Classication:CISPR11Group1ClassA

13
Operation Manual
Electromagnetic Compatibility
TABLE:Guidance and manufacturer's declaration - electromagnetic emissions
TheX-eraSmartisintendedforuseintheelectromagneticenvironmentspeciedbelow.
The customer or the user of the X-era Smart should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The X-era Smart uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The X-era Smart is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those
directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes, provided the following
warning is heeded:
Warning: This equipment/system is intended for use by healthcare
professionals only. This equipment/system may cause radio
interference or may disrupt the operation of nearby equipment. It may
be necessary to take mitigation measures, such as re-orienting or
relocating the X-era Smart or shielding the location.
Harmonic emissions
IEC 61000-3-2 Class A
Voltageuctuations/
ickeremissions
IEC 61000-3-3
Complies
TABLE: Guidance and manufacturer's declaration - electromagnetic immunity
TheX-eraSmartisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerorthe
user of the X-era Smart should assure that is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floors should be wood, concrete,
orceramictile.Ifoorsare
covered with synthetic material the
relative humidity should be at least
30%.
Electrical fast
transient / burst
IEC 61000-4-4
±2kVforpowersupplylines
±1kVforinput/outputlines
±2kV
±1kV
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kVdifferentialmode
±2kVcommonmode
±1kV
±2kV
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltagedips,short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0,5 cycles
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
Functions Interruption
Functions Interruption
Functions Interruption
Functions Interruption
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
X-era Smart requires continued
operation during power main
interruptions, it is recommended
that the X-era Smart be powered
from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magneticeld
IEC 61000-4-8
3 A/m Complies
Powerfrequencymagneticelds
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.

14 Operation Manual
TABLE: Guidance and manufacturer's declaration - electromagnetic immunity
TheX-eraSmartisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerorthe
user of the X-era Smart should assure that is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment –
guidance
Conducted RF
IEC 61000-4-6
3Vrms
150 kHz to 80 MHz 3V
Portable and mobile RF communications
equipment should be used no closer to
any part of the X-era Smart, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
d=1.2√P
d=1.2√P80MHzto800MHz
d=2.3√P800MHzto2.5GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
FieldsstrengthsfromxedRF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity
of equipment marked with the following
symbol:
Radiated RF
IEC 61000-4-3
3V/m
80 MHz to 2.5 GHz 3V/m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionandreectionfromstructures,objectsandpeople.
a:Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless),telephones
andlandmobileradios,amateurradio,AMandFMradiobroadcast,andTVbroadcastcannotbepredicted
theoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetoxedRFtransmitters,an
electromagneticsitesurveyshouldbeconsidered.Ifthemeasuredeldstrengthinthelocationinwhichthe
X-era Smart is used exceeds the applicable RF compliance level above, the X-era Smart should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the X-era Smart
b:Overthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan3V/m.

15
Operation Manual
TABLE: Recommended separation distances between portable and mobile RF
communications equipment and the equipment
The X-era Smart is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the X-era Smart can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment and the X-era
Smart as recommended below, according to the maximum output power of the communication equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitter rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionandreectionfromstructures,objectsandpeople.
*Warning
Useofaccessories,transducers,andcablesotherthanthosespeciedmayresultindegraded
electromagnetic compatibility performance of this device!

16 Operation Manual
Storage and Usage Environment Precautions
Do not operate or store the equipment in the environment as described below. If you must
operate or store it in such an environment, contact YOSHIDA or your dealer prior to use or
storage.
1. Inareaswithatemperaturerangethatexceedsthevaluesstatedinthespecications.
2. Areas where the air pressure is less than 700 hPa or over 1060 hPa.
3. Areas subject to harmful gases.
4. Areas with excessive relative humidity (30 to 75%, no condensation).
5. Areas subject to steam.
6. Areas subject to water drops.
7. Areas with much dust or sand.
8. Areas with much oil vapor.
9. Areas subject to salty air.
10. Areas containing explosive gases or dust.
11. Areas subject to excessive vibration or shock.
12. Areas with a noticeable slope.
13. Areaswherethepowervoltageuctuatesabnormally.
14. Areas where the power voltage drops excessively when a load is applied.
15. Areas subject to direct sunlight.
16. Areas where chemical products are stored.
17. Areas where developer units are installed.
18. Areas exposed to intense noise.
*Caution
• Be sure to use the equipment at ambient temperatures of 10 - 40 degree C.
If used at other range of temperature, it may not work properly.
See also : For information regarding Storage and Usage Environment Precautions of the
computer, refer to the Product Information Guide included with the computer at
delivery.

17
Operation Manual
Precautions for Installation and Relocation
1. Installation Areas
(1) Install in the X-ray room.
(2) The size of the installation area should be at least 1,350 mm (W) × 1,350 mm (D) ×
2,400 mm (H) or 54" (W) × 54" (D) × 95" (H) (* in case of Cephalometric -attached
model, 2,300 mm (W) × 1,500 mm (D) × 2,400 mm (H) or 92" (W) × 60" (D) × 95"
(H)), to allow the patients to be put in and taken out, the equipment to be operated,
the equipment to be used correctly such as allowing for daily inspections, and to
perform work to maintain equipment performance.
If installed alongside other pieces of equipment, be sure not to place them within the
range of the arm unit’s movement.
The installation area size differs depending on the room shape, door locations, etc.
For details contact the dealer where the equipment was purchased.
(3) Rapidly warming a cool X-ray room results in condensation inside the equipment that
causes problems. When heating a room, do so slowly.
The environmental range for using this equipment in good condition is as follows.
Temperature: 10 to 40ºC (50 to 95°F)
Relative humidity: 30 to 75% (no condensation)
Air pressure: 700 to 1060 hPa
(4) Installintheareaequippedwithlightxturetoensuretheproduct’soperability,X-ray
image quality and its viewability. Set the monitor to the area where is unaffected by
thelightreectionfromindoorsandoutdoors.
2. Power
(1) Prepare a hospital grade outlet (grounding is required) of your area’s power voltage
and dedicate it for X-era Smart
 100V:MorethanAC100V,15.0A
 110V:MorethanAC110V,18.1A
 120V:MorethanAC120V,16.6A
 220V:MorethanAC220V,9.09A
 230V:MorethanAC230V,8.69A
 240V:MorethanAC240V,8.33A
(2) Never use an extension cord or plug multiple cords into one outlet.
(3) Wipe off dust that has accumulated on the power plug and outlet. Leaving the dust
onthemcouldallowaminuteelectricalcurrenttoowduetohumidity,etc.,and
resultinoverheatingorare.
(4) Do not impair, damage, or modify the power cord. In addition, do not place heavy
objects on it, pull on it, or bend it excessively as these could damage the power cord
andcauseareorelectricalshock.
(5) Be sure to connect the additional protective groundings of the main unit and the
computer.

18 Operation Manual
3. Grounding
This product is grounded by plugging the medical grade plug into a medical grade outlet.
4. Movement and Transport
To move or transport this equipment, contact the dealer where the equipment was
purchased.
*Caution
Federallawrestrictsthisdevicetosalebyorontheorderofadentistorotherqualiedprofessional.(forUSA)