Page 1
Operation 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...
• Reproduction or reprint of part or all of the manual without prior written permission is strictly prohibited. • Modifications 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.
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 ....................
Page 5
Cooling Time ......................... 50 Software ........................51 2 Directions for Use Pre/post-operational Procedures .................. 52 Emergency Stop ......................53 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...
Page 6
3 Directions for Use of X-era Smart ControlManager Starting up X-era Smart ControlManager ..............105 Descriptions of Unit Information Monitor ..............105 Descriptions of “Setup” Screen ................... 105 3.4 Confirming Program Versions ..................107 3.5 Configuring a Communication Port (s) ................ 108 4 Directions for Use of Image Creator About the Patient Selection Screen ................
Page 7
8 Disposal 9 Patient Positioning Part 10 List of Periodical Replacement Parts and Consumable Replacement Parts 10.1 Periodical Replacement Parts ..................134 10.2 Consumable Replacement Parts ................134 11 Main Specification 11.1 Specification ........................ 135 11.2 Filter Specifications ..................... 139 11.3 Dimensional Drawing ....................140 11.3.1 Standing position wall-mount: Panoramic type ..............140 11.3.2...
Page 8
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) 12.1 Structure of the Installation Phantom ................
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 fire, serious damage to the equipment and its surrounding proprietary (e.g.totally lost...
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.
Page 11
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.
Page 12
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.
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...
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,...
Page 15
Electromagnetic Compatibility TABLE:Guidance and manufacturer's declaration - electromagnetic emissions The X-era Smart is intended for use in the electromagnetic environment specified 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 The X-era Smart uses RF energy only for its internal function.
Page 16
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, field strengths should be less than 3 V/m.
Page 17
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.
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 specifications.
Set the monitor to the area where is unaffected by the light reflection 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...
Page 20
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 qualified professional.(for USA) Operation Manual...
• Perform only the operations described in this manual. • Always follow the instructions in the labels affixed to this product. Intended Use The X-era Smart dental panoramic, cephalometric (*) and 3D(**) image acquisition device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.
Page 22
Before Using this Product * Equipment with Cephalometric ABCDEGHPT Operation Manual...
Page 23
Before Using this Product 0 0 8 6 Operation Manual...
Page 24
Before Using this Product T: Certification Statement Label U:FOV Label (**) ** For equipment with 3D function Operation Manual...
Before Using this Product Names and Functions of Units and Their Parts 1.3.1 Main body ** For equipment with 3D function * Equipment with Cephalometric For 3D Operation Manual...
Page 26
The sliding mechanism being moved up and down to align to the patient's Column unit target level by means of an electric actuator. Power switch Supplies power to X-era Smart (ON: power supplied, OFF: no power supplied.) Emergency stop switch When pressed in case of emergency, X-era Smart stops. May be used depending on the strength of the floor, on which the equipment is Base unit (optional) installed.
Page 27
Before Using this Product Name Function Converts X-ray absorption data into electronic data in response to the signals Sensor unit (movable) from the controller during image acquisition to output to the PC. Depending (**) on each image acquisition mode, the internal driving mechanism slides the sensor unit.
Before Using this Product 1.3.2 Names and functions of control panel switches and indicators (1) Each of the control panel switches executes its own function, moves the sliding mechanism up or down, moves the arm unit forward or backward, specifies radiography settings, irradiates the positioning beam, etc. A buzzer will go off intermittently during X-ray exposure. Operation Manual...
Page 29
Before Using this Product Name Function When pressed, switches between "Panoramic", "Child","Partial Panoramic Single Panorama", "TMJ", and Single to select any of these exposure modes. Partial Child The LED associated with selected Panorama mode will go on. * For equipment with Cephalometric, it switched between "Panoramic", "Child", "Partial Panorama", "TMJ", "Single", "Cephalometric...
Page 30
Before Using this Product Name Function Used to specify any value for "Tube voltage", "Tube current", and "Exposure time". "+" increases the current value by one level and "-" decreases by one level. "+" and "-" switch For more information on the allowable ranges of tube voltage, tube current, and exposure time, see "Parameter settings table"...
Before Using this Product 1.3.3 Names and functions of control panel switches and indicators (2) Name Function 1 Exposure mode indicator Panoramic, : Panorama LED turns on, if selected. Partial Panoramic Child panoramic : Child LED turns on, if selected. : TMJ LED turns on if selected.
Before Using this Product 1.3.4 Names and functions of hand-switch box indicators and switches Name Function X-ray LED (yellow) Stays on during X-ray exposure with an intermittent buzzer sound. Flashes while the equipment (e.g. the rotating arm) is operating; turns on when it has returned to its reset position in each exposure mode;...
Before Using this Product 1.3.5 Head support unit The head support unit supports and makes the patient’s head immovable at the give position during radiographic image acquisition. Name Function Supports the patient's forehead to avoid back and forth movement of the Forehead support (* patient's head.
Before Using this Product 1.3.6 Positioning beams Positioning for Panoramic Image Acquisition Pressing any of the positioning beam switches activates its associated positioning beam (at the same time, the arm unit moves to the positioning point). These positioning beams can be used to make the patient’s head immovable at the position appropriate for image acquisition.
Page 35
Before Using this Product Positioning for 3D image acquisition Press the positioning beam switch on the control panel to turn on the positioning beam (the arm unit moves to the positioning point). Adjust the intersection of the Midsaggital vertical beam and the Canine beam to the center of 3D. Name Function Midsaggital vertical beam...
Before Using this Product 1.3.7 Sensor unit (detachable) Name Function Handle When docking station the sensor, hold the handle to retain it. Knob for detaching Rotate the knob to fix the sensor to the docking station. Locking/unlocking position of the knob for detaching When locking When unlocking Caution • Be sure to hold the handle when detaching the sensor. The sensor may drop if you hold other parts.
Before Using this Product 1.3.8 Cephalometric unit (*) Name Function Ear rod Adjusts to the patient’s porus acusticus and fixes the head. Nose support Adjusts to the center of patient’s eyebrows and fixes the head. This unit converts the X-ray absorption data into electronic data by the Cephalometric sensor signal from the control device and exports the image to the computer (Panoramic/Cephalometric- unit.
Page 38
Before Using this Product Carpus support Carpus Support Attaching Screws When acquiring carpus images, attach the carpus support to the cephalometric main unit. Attach the carpus support by fastening the screws into the screw holes on the cephalometric main unit. Carpus Support Carpus Support Attaching Screw Holes Carpus Support edge...
Before Using this Product 1.3.9 Positioning beam allocation X-era Smart equips with a laser beam as patient positioning beam allocated in the position shown below. Laser beam Operation Manual...
Before Using this Product 1.3.10 Sensor unit (movable) (**) Sensor position for Panoramic and Cephalometric (image looking from head unit) 3D left position 3D center position 3D right position Sensor position for 3D (image looking from head unit) ** For equipment with 3D function Operation Manual...
Before Using this Product 1.3.11 Head fixator for 3D image acquisition(**) This part is attached to chin rest base for patient positioning while 3D image acquisition. Bite plate attaching hole Attaching pin (for front teeth image) Attaching pin (for Attaching pin (for wisdom teeth image) molar teeth image) Bite plate Name...
Page 42
Before Using this Product Left-right slide Fixes the left-right sliding. Loosen to adjust the left-right position of fixing knob the forehead support. Holds up the forehead support. There are two marks on both sides 7 Shaft which indicate FOV height. Upper mark shows the upper end of FOV and the lower mark shows the lower end of FOV. Up-down Adjusts the attachment and height of bite plate. positioning unit Up-down lock Fixes the up-down positioning unit at the arbitrary height.
Before Using this Product Materials of Applied Parts The applied parts coming in contact with the patient have been made of the materials described below. Name Function Chin rest block ABS resin, PC resin (adaptor for edentulous jaw) Head support ABS resin Handle ABS resin...
Before Using this Product Principle of Operation 1.5.1 X-ray generating mechanism An X-ray beam is generated using part of the kinetic energy converted when electrons rapidly spinning decelerate in the material. To accelerate the thermoelectrons of the X-ray beam emitted by an X-ray tube, several tens kilo voltages of high DC voltage is required. To this requirement, an internal high-voltage transformer increases the voltage by several hundreds voltage.
Before Using this Product 1.5.3 Principle of Radiographic Panoramic modes Keep pressing the X-ray Exposure switch to rotate the arm unit. The X-ray tube assembly that irradiates a narrow beam is suspended to the arm unit. The arm unit rotates at a specified speed around the stationary patient. During the arm unit rotation, data will be acquired by the Sensor unit multiple times.
Before Using this Product Radiographic Functions 1.6.1 Functions of exposure modes Panoramic Panoramic images of the patient’s dental arch may be acquired in a normal exposure time (approximately 14 seconds). Standard panoramic mode trajectory Child panoramic For child and small female patients, the child panoramic mode can be used to acquire images in a shorter exposure time (normal: approximately 11.2 seconds).
Page 47
Before Using this Product TMJ mode Split images of the patient’s temporomandibular joint can be acquired in an exposure time of 4 seconds/stage. TMJ-mode trajectory Cephalometric radiography (*) Choose between posteroanterior image (PA) and lateral image (LA). Image acquisition time for a posteroanterior and a lateral image is 8 seconds and 10 seconds respectively.
Page 48
Before Using this Product 3D Oral image radiography (**) Images acquired from clockwise image acquisition (irradiation time 11.5 seconds) and counter-clockwise image acquisition (irradiation time 11.5 seconds) are combined. Reconfigure the combined images to acquire a large FOV 3D image. (FOV: Diameter 77mm, height 54mm) First image acquisition (clockwise) projection image combining images right side projection image left...
Before Using this Product 1.6.2 Selecting Exposure status You may select either exposure status of AUTO or MANUAL. Exposure status AUTO : The tube voltage, tube current, and exposure time are automatically set appropriately for the size of the patient’s dental arch. In case of Cephalometric radiography and Carpus radiography, tube voltage, tube current and exposure time are set to default of each image acquisition mode.(*)
Before Using this Product 1.6.3 Names of arm unit positions Start / Reset position For 3D image acquisition, start position moves 60mm backward than the Panoramic start position (**). Patient positioning position Patient entry position Patient exit position Operation Manual...
Page 51
Before Using this Product Cephalometric and Carpus radiography position (*) ° Sensor detachment position ° For equipment with Cephalometric For equipment with 3D function Operation Manual...
Before Using this Product Cooling Time The equipment has incorporated a variable-cooling time function. X-ray radiographic may be repeated consecutively three or four times after it has not been used for a long time; however, the X-ray tube head, once reaching a given temperature, should be cooled for a given time depending on the radiographic conditions as shown in the following table.
Before Using this Product Software X-era Smart ControlManager Confirmation of the following features: exposure Condition, projection Mode, projection Status and Main Unit Circuit Board Program Version, User Program Mode Settings and Communication port Settings can be configured. Image Creator Projection Mode settings, Acquisition of images, Formulation of Panoramic images, Adjustment of the Tomographic plane of Panoramic images, and Transfer of the images to a Viewer software can be configured. Operation Manual...
Directions for Use 2 Directions for Use Caution • To assure the operator’s and patient’s safety, be sure to read through this section prior to use of the equipment. Pre/post-operational Procedures Pre-operational procedure Plug the power cable of the equipment into the medical ground outlet. Check the surrounding area of the equipment 'to make sure' there is no object that interferes with the X-ray radiography.
Directions for Use Emergency Stop In case of an emergency, one of two steps described below should be followed to immediately stop the equipment. Emergency stop switch By releasing the X-ray exposure switch during image acquisition, X-ray irradiation and image acquisition will stop immediately and Er08 will be displayed on the control panel. See also : "6.1.2 Troubles associated error messages displayed on the screen"...
Directions for Use Procedure of Panoramic and TMJ Radiography 2.3.1 Turning the power switch on Turn the computer’s power switch on. Turn the power switch on ( | ) on the equipment to check that the power LED (green) has been turned on (also, check that the Emergency Stop switch has been disabled).
Creator using TWAIN function of the viewer: Drop” function of Image Creator: Start up the viewer. Start up the viewer. Set Yoshida in equipment setting. Start up Image Creator. Start TWAIN function. The main screen of Image Creator is displayed.
Directions for Use 2.3.3 Setting the Exposure mode From the control panel: To set the Exposure mode: Keep on pressing the Mode switch until the mode you desire is selected from "Panoramic", "Child","Partial Pan- orama", "TMJ" and "Single". The LED associated with the selected mode will illuminate.
Page 59
Directions for Use To which the mode is switched when Mode Exposure Mode Function switch is pressed Acquires panoramic images of the patient's Panoramic dental arch in exposure time, normally 14 sec. Acquires panoramic images of the child Child Panoramic patient's dental arch in exposure time, normally 11.2 sec.
Page 60
Directions for Use Press the Select switch to select “Auto” or “Manual” switches. The LED associated with the selected mode will turn on. To which mode is switched when Select Exposure status Function switch is pressed Specifies automatically the values for Tube AUTO voltage and Exposure time appropriate for the patient's dental arch size.
Page 61
Directions for Use Click “New” in the main screen of Image Creator and Image Acquisition Condition Setting screen is displayed. Make sure that the settings in the screen match with the settings made on the Control Panel, and press “OK”. From the Image Creator : Set up the image acquisition mode using the Image Creator on the computer.
Page 62
Directions for Use In the “Image Acquisition Condition Setting” screen, select mode, status and parameters (tube voltage, tube current, Exposure time) of the image acquisition, and press “OK”. The setting information is transferred to the main equipment. Suppl. : Once having confirmed the modification by clicking on “Set”, you can no longer restore the previous setting (s) even by clicking “Cancel”.
Page 63
Directions for Use Preparation for using an adaptor Insert an adaptor appropriate for the selected exposure mode into the chin rest block. Insert a bite block (2) into the chin rest block (1). Panoramic mode To acquire the images of the patient with edentulous jaw or with no front teeth, insert the adaptor for edentulous jaw into the chin rest block.
Directions for Use 2.3.4 Seating the patient inside the equipment Caution • Be sure to ask the patient to wear an X-ray protective apron and child patients to wear both the X-ray protective apron and a thyroid shield prior to X-ray exposure. • Ask the patient to remove eye glasses and accessories prior to X-ray exposure, otherwise they may be reflected on the images.
Page 65
Directions for Use Seating the patient inside the equipment Spread the head support open by holding the base portion and seat the patient inside the equipment. Instruct the patient to sit straight up, bite on to the block and grip the handles. (Panoramic) Warning • Do not apply heavy load or shock on to the equipment, e.g.
Page 66
Directions for Use Suppl. : Patient on a wheelchair Position the patient in a wheelchair all the way to the column so that the patient is able to have their back straight and sit upright. When an optional normal-sized base is used, position the wheelchair so that the front wheels sit nicely between the base and rear wheels are free from...
Directions for Use 2.3.5 Patient Positioning in Panoramic mode Warning • 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.
Page 68
Directions for Use Suppl. : Improper midsagittal vertical beam alignment may affect the images as described below. 1. Inclined patient’s face Problems • Prominent difference between the tops of left and right temporomandibular joints. • Distorted image with a difference in size between left and right mandibular angles.
Page 69
Directions for Use Aligning the Frankfurt horizontal beam Move the sliding mechanism up or down so that the Frankfurt horizontal beam may be positioned parallel to the Frankfurt horizontal patient’s Frankfurt plane. beam Warning • Do not apply heavy load or shock on to the equipment, e.g. suspending from the chin rest or handle.
Page 70
Directions for Use 2. The patient's face inclined upward Problems • Blurred maxillary front teeth. • Patient's hard palate overlapped on the root apexes on the maxillary tooth row. Possible causes • The patient's face inclined upward. • The patient's mandible inclined anteriorly. Corrective measure • Align the reference facial plane to the horizontal reference line (horizontal line)
Page 71
Directions for Use Suppl. : Improper beam positioning on the mandibular third tooth may have the following complications; 1. The patient's face inclined downward Problems • Blurred root apexes of mandibular front teeth. • Patient's hyoid bone overlapped on the mandibular front teeth.
Page 72
Directions for Use Adjusting the head support Slide the head support in contact with the patient’s head while gripping its base and then close it. With the Auto setting, the tube voltage appropriate for the patient will be automatically set. At the end of adjustment, try to turn on the positioning beams to check that they focus on their correct positions.
Directions for Use 2.3.6 Patient Positioning in TMJ mode Caution • If the rotating arm unit deviates from its correct position, e.g. when it hits against the patient’s shoulder, positioning may not be correctly performed. To avoid this problem, be sure to return the arm unit to its reset position and then retry.
Page 74
Directions for Use Warning • 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. Suppl.
Page 75
Directions for Use Adjusting the forehead support Slide the forehead support in contact with the patient’s head by gripping its base and then close it. With the Auto setting, the tube voltage appropriate for the patient is automatically set. At the end of adjustment, turn on the positioning beam again to confirm that the beam is right on the proper point.
Directions for Use 2.3.7 X-ray Exposure Warning • Ask the patient not to move during image acquisition, otherwise the patient may be caught by the rotating arm. Monitor the patient throughout image acquisition and in case of an emergency, immediately stop the equipment. Caution • Only trained and qualified person should take radiographic photos. The use of this equipment by unqualified person is prohibited by law.
Page 77
Directions for Use The equipment employs a dead man’s switch *. If the finger is removed from the X-ray exposure switch, the X-ray exposure and image acquisition operation stop. * Dead man's switch: A system which operates only when the operator applies force to the equipment. Caution • If the X-ray exposure switch is released during an exposure, X-ray exposure and image acquisition will be stopped and an exposure error will occur, requiring a retake and consequently increases the patient dose.
Page 78
Directions for Use ● Radiography at mouth opened position Ask the patient to open the mouth with the TMJ adaptor attached to the subnasal point. Check that the patient has opened the mouth and then press and hold down the X-ray Exposure switch until image acquisition is successfully finished.
Directions for Use 2.3.8 Patient's Exit Open the head support. Ask the patient to move backward carefully. Caution • When the patient makes his/her exit, make sure to escort and lead the way. Since the patient needs to move backward when removing him/herself from the equipment, the patient might trip over or cause similar accidents.
Directions for Use Click "OK" to transfer the image using the TWAIN function. To transfer the image using the "Drag & Drop" function, drag the "Drag" button from the upper left on the screen and drop it on the display window of the Viewer. NOTE : Since a panoramic image has been converted...
Directions for Use Procedures of Cephalometric and Carpus Radiography 2.4.1 Turning the power switch on See also : "2.3.1 Turning the power switch on" 2.4.2 Flow of Image Acquisition See also : "2.3.2 Flow of Image Acquisition" 2.4.3 Setting the Exposure Mode Setting the Exposure mode using the control panel See also :"From the control panel:"...
Directions for Use Caution • Before initiating the image acquisition, make sure that the sensor unit (detachable) is firmly attached and locked to the docking station unit (Cephalometric ). • The detachable 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.
Page 83
Directions for Use Preparation for the Patient's entry and Positioning Press the Reset Switch on the Control Panel. The arm unit and sensor unit automatically move to the Cephalometric image acquisition position, and the slits in the head unit automatically switch. Before inviting the patient in, move the ear rod to an approximate position of his/her height.
Page 84
Directions for Use Seating and Positioning the Patient After seating the patient, move the ear rods upward or downward to match the heights of patient’s porus acusticus. Insert the ear rod into the porus acusticus on one side and close the ear rod.
Directions for Use support. Caution • In order to minimize the patient dose, make sure that the image acquisition is done with a correct positioning. • Slide the ear rods by gripping their upper portion (closer to the head) to widen or narrow. The patient might get injured if excessive force is applied to move the ear rods.
Page 86
Directions for Use Make sure that the Ready LED (green) is turned on and the equipment is ready for image acquisition.Press the X-ray exposure switch to begin X-ray radiography. By holding the X-ray exposure switch down, X-ray is irradiated according to the acquisition time specified. While X-ray is being irradiated, the X-ray LED (yellow) on the hand-switch box is lit and a buzzer...
Directions for Use Once an X-ray acquisition commences, the display will change from "standby" screen to the "acquisition" screen. In the acquisition screen, image construction is displayed simultaneously with the acquisition progress. NOTE : To make it easier to handle by cephalo analysis tools and other features, when cephalo LA image is...
Directions for Use Click "OK" to transfer the image using the TWAIN function. To transfer the image using the "Drag & Drop" function, drag the "Drag" button from the upper left on the screen and drop it on the display window of the Viewer. NOTE : Since a Cephalometric image has been converted...
Directions for Use Procedure of 3D Radiography 2.5.1 About 3D image acquisition (a) 3D Acquisition mode 3D Acquisition mode has "3D Oral Image" and "3D Dental Image". 1. 3D Oral image Move the 3D sensor position to the right. Images acquired from clockwise image acquisition (irradiation time 11.5 seconds) and counter-clockwise image acquisition (irradiation time 11.5 seconds) are combined and reconfigured to acquire a large FOV 3D image.
Page 90
Directions for Use (b) FOV position 1. FOV of 3D Oral image FOV Oral seize Operation Manual...
Page 91
Directions for Use 2. FOV of 3D Dental image FOV Dental size Operation Manual...
Directions for Use 2.5.2 Turning the power switch on See also : "2.3.1 Turning the power switch on" P.54 2.5.3 Openingng the image formulating window of Image Creator See also : "4 Directions for Use of Image Creator" P.110 2.5.4 Setting the Exposure Mode Setting the Exposure mode using the control panel See also...
Page 93
Directions for Use 2.5.5.2 Move to 3D image starting position Press the reset switch from the control panel. Arm unit and movable sensor move to 3D image position automatically. The movable sensor moves to the selected 3D image mode position automatically. Caution • Remove the head support before pressing the reset switch from the control panel.
Page 94
Directions for Use 2.5.5.4 Preparing the bite plate and the impression material Caution • To prevent the patient from infection, always use new bite plate and impressing material for each patient. Wipe off the bite plate with alcohol-dampened cloth prior to use to maintain cleanliness.
Page 95
Directions for Use 2.5.5.6 Attaching position of the bite plate Adjust the bite plate to the image acquiring position and attach it to the shaft unit of the head fixator for 3D image acquisition. For front teeth image acquisition, insert the rear row pins of the bite plate to attach.
Page 96
Directions for Use 2.5.5.7 Positioning of 3D image acquisition Warning • Do not look directly into the positioning beam although the power output (Class 2) is at the level in which adverse effect on the eyes can be avoided by blinking. Caution • Positioning beam is a laser beam.
Page 97
Directions for Use 2. How to adjust the center of FOV Position adjustment of front-back direction Press forward switch or back switch of the control panel to adjust the front-back direction of the center of FOV. It moves ±10mm in front-back direction towards the column unit. Position adjustment of left-right direction Loosen the left-right slide fixing knob of the head fixator for 3D image acquisition to adjust the left-right direction of the center of FOV. After adjustment, tighten the slide fixing knob. It moves ±20mm in left-right...
Page 98
Directions for Use 2.5.5.9 Adjusting the chin rest height Caution • Be sure to ask the patient to wear an X-ray protective apron and the child patient to wear both X-ray protective apron and a thyroid shield. • Ask the patient to remove eye glasses and accessories prior to X-ray exposure. Otherwise, they may be reflected on the images.
Page 99
Directions for Use 2.5.5.11 Adjusting forehead support Adjust the vertical and horizontal position of the forehead support of the head fixator for 3D image acquisition so that it fits the patient's forehead. Adjusting vertical position The forehead support can slide vertically if the up-down slide fixing knob is loosened. Position the forehead support at the height of the patient's head, and tighten the up- Front-back slide down slide fixing knob. fixing knob Up-down slide fixing knob Adjusting horizontal position The forehead support can slide horizontally (front-back) if the up-down slide fixing knob is...
Page 100
Directions for Use 2.5.5.13 Gripping on the handles Ask the patient to stretch his/her back and grab the handles. Warning • Do not apply heavy load or shock on to the equipment, e.g. suspending from the chinrest or handle. Failure to follow this instruction may cause damage to the equipment.
Page 101
Directions for Use Suppl. : Patient on a wheelchair Position the patient on a wheelchair all the way to the column so that the patient is able to have the back straighten and sit upright. When an optional normal-sized base is used, position the wheelchair so that the front wheels sit nicely between the base and rear wheels are free from hitting the base.
Directions for Use 2.5.6 X-ray Exposure Caution • Only trained and qualified person should take radiographic photos. X-ray exposure (or image acquisition) by unqualified person is prohibited by law. • To minimize the X-ray exposure, properly position the patient. • Instruct the patient not to move during the image acquisition. When the patient moves during the image acquisition, the image may get blurred and the quality low. Especially for 3D oral image acquisition, advise the patient to stay still until the whole process of the acquisition is completed.
Page 103
Directions for Use Make sure that the Ready LED (green) is turned on and the equipment is ready for image acquisition. Press the X-ray Exposure switch to start image acquisition. Holding down the switch activates X-ray Exposure during the specified Exposure time. While X- ray is irradiated, the X-ray indicator (yellow) on the hand-switch box turns on, and the buzzer continually buzzes.
Directions for Use 2.5.7 Patient's Exit Remove the head band on the head fixator for 3D image acquisition, and instruct the patient to step straight back. Caution • When the patient makes his/her exit, make sure to escort and lead the way. Since the patient needs to move backward when removing him/herself from the equipment, the patient might trip over or cause similar accidents.
Directions for Use Image Creator's Image Construction screen activates the 3D viewer software, and transfers the 3D image. The 3D image transferred into the 3D viewer software is displayed. Caution • Malfunctions or erroneous operations such as unintended formatting on the hard disk drive might render important data or programs inoperative.
Directions for Use of X-era Smart ControlManager 3 Directions for Use of X-era Smart Control- Manager In ControlManager, Confirmation of the exposure Condition, the exposure Mode, the exposure status, the User Program Mode Settings, Confirmation of the Main Unit Circuit Board Program Version and Communication Port Settings can be configured. NOTE : When the software needs to be reinstalled due to replacement of computers, etc., the installation procedure needs to be done by a professional service personnel only.
Directions for Use of X-era Smart ControlManager Starting up X-era Smart ControlManager At the computer’s boot-up, ControlManager automatically starts on the background. While ControlManager is active, displayed on the task tray. Descriptions of Unit Information Monitor Clicking “Radaition Information” brings up “Unit Information Monitor”on the PC screen.
Page 108
Directions for Use of X-era Smart ControlManager Click the program number of the program to be modified to select. Click the button associated with the setting to be modified. The left-hand dialog will open. To confirm the modification, click “OK”. Suppl. : In the User Program Mode, any operation from the exposure switch or the control panel is not activated.
Directions for Use of X-era Smart ControlManager Confirming Program Versions Click “About” in “Main Menu”. The “Program Version Confirmation” screen will open. Program versions are listed as shown in the following screen. 1. Main program version 2. Control panel program version 3. Hand Switch Box program version 4.
Directions for Use of X-era Smart ControlManager Configuring a Communication Port (s) Click “About” in “Main Menu”. The “Version Confirmation” screen will open. Click “Port Setting”. The “Port Setup” dialog will open. From the pulldown menu, select your desired port (s) and then click “OK”. You will return to the “System Setup”...
Page 111
(The assigned numbers are not always serial numbers.) With more than one port incorporated in the equipment, you need to indicate (configure) which port is connected to the PC via cabling. X-era Smart ControlManager can be used to select your desired port (s) from a port list for easy configuration. Selecting any wrong port will bring up an error message;...
Directions for Use of Image Creator 4 Directions for Use of Image Creator Using Image Creator in order to set up the image acquisition mode, acquire images, formulate panoramic images, adjust the tomographic setting of panoramic images, and transfer images to the Viewer. NOTE : If the software needs to be reinstalled due to replacement of computers, etc., the installation procedure needs to be done by professional service personnel only.
Directions for Use of Image Creator About the Launcher Screen Select a patient in the patient selection screen, and the launcher screen appears. The image construction screen, 2D image viewer, and 3D image viewer can be activated from the launcher window. Operation Manual...
Directions for Use of Image Creator How to use the Image Construction Screen Image Creator main image (without panorama pictures) Image Creator main image (with panorama pictures) Operation Manual...
Page 115
Directions for Use of Image Creator Name Function Image Display Area Displays acquired image. Loads the RAW data, the last image acquired. Such operations can be done “Call Back Last Image” on the loaded RAW data as reformulation and readjustment of tomographic Button setting on the panoramic or Cephalometric radiographic images.
Directions for Use of Image Creator Name Function When a time-consuming process, such as reformulation of panoramic or 15 Progress Display Cephalometric radiographic image is in progress, the processing progress is displayed. Exports the image newly acquired or formulated by tomographic adjustment 16 “Export”...
Directions for Use of Image Creator Select and Export Press the Export button and the acquired data can be named and saved. The saved data can be selected and loaded using "Select" button to specify the file. NOTE : The file size of acquired data is approximately 900 MB. Please check the capacity of destination disk when saving the file using Export. Since the file size of acquire data is approximately 900MB, loading acquired data using Select takes time. Tomographic Adjustment Manual Adjustment When “Preview”...
Page 118
Directions for Use of Image Creator Auto-Focus Click on the Domain button (1) to set the rectangular domain on the panoramic image, By selecting a rectangular domain on the panoramic image and pressing “Auto-Focus(2)”, the panoramic image is reformulated by the selected domain being focused and the tomographic domain being automatically readjusted.
Directions for Use of Image Creator Display Adjustment By operating the Display Adjustment Buttons, the left-drag function of the mouse for the Image Display area can be chosen. Domain Button Domain Button is used when defining a rectangular domain on the image shown at the Image Display area. A rectangular domain is defined by the mouse’s left-dragging from the starting coordinates to the ending coordinates. Only one rectangular domain can be set for the displayed image.
Directions for Use of Image Creator Image Export The image shown at the Image Display area can be transferred to the viewer or exported as a file in TIFF format. Transfer to the viewer • Transfer Using TWAIN When Image Creator is activated from the viewer using TWAIN, press “OK” to transfer the image shown at the Image Display area to the viewer.
In the User Program Mode, various settings can be made so that this equipment can be operated more easily. The settings can be made in “Image Creator” or “X-era Smart Control- Manager” software installed on the computer. Refer to Descriptions of User Program Mode in the end of this section for the program number and display contents.
Page 122
User Program Mode Click and select the User Program Number that needs adjustment. Press the button of the setting value needing adjustment. A dialog box as in the figure on the left is displayed and the setting is completed. Operation Manual...
Page 123
User Program Mode Descriptions of User Program Mode Program No. Description Setting Default Specifies whether an Audible alarm audible alarm sounds Prog No.02 when any button is On: an alarm sounds Off: no alarm sounds pressed on the touch panel. Specifies whether Patient positioning point (after acquisition) the arm automatically Prog No.03 moves to the patient...
Trouble Shooting 6 Trouble Shooting Troubles and Their Corrective Measures 6.1.1 Troubles with image acquisition These troubles should be appropriately addressed according to the corrective measures described in "Corrective measures for troubles with image acquisition". Corrective measures for troubles with image acquisition Symptom Possible cause Action...
Page 125
Trouble Shooting Symptom Possible cause Action Failed unit Contact your dealer. With the power switch on ( | ), X-ray The emergency stop switch has been Turn the emergency stop switch clockwise cannot be exposure. pressed. to release the switch. The X-ray tube has been shorted out or a gas has been generated in it.
Page 126
Trouble Shooting (For equipment with 3D function only) Symptom Possible cause Action 3D image was acquired while a Acquire a 3D image after closing all panoramic image was open. images. Reconstruction of When acquiring 3D images on multiple 3D image is not parts, proceed with the next image 3D images on multiple parts of the same completed.
Trouble Shooting 6.1.2 Troubles associated error messages displayed on the screen If an error message appears on the control panel, follow the corrective measures described in "Error message code list" to fix. Error message code list Error code Description Action Press the Reset switch on the The X-ray exposure switch has been released during Er08 control panel to recover from the...
If any problem persists even though the appropriate corrective measure described above has been taken, contact your dealer and provide information on: 1. Product name (X-era Smart) and its serial number (**-****). 2. Operation, which might cause the failure (as detailed as possible).
Maintenance Services 7 Maintenance Services X-era Smart has been designed so that the user may take full use of it reliably and satisfactorily over many years. To assure the operator’s and the patient’s safety in using the equipment, the user is responsible for performing preventive maintenance services.
Maintenance Services 7. Cleaning the ear rod, nose support and carpus support (*) Dampen a soft cloth with mild detergent, wring well and wipe out dirt from the ear rod, nose support and carpus support. Wipe away moisture with a dry cloth. 8.
12 months Electrical safety is assured. every 12 months 7.3.2 Archiving records on Periodical check To ensure the reliability and safety of X-era Smart, be sure to archive the result records on regular check and scheduled check services. Operation Manual...
Maintenance Services Performing Regular Check Services 1. Installation: The equipment is properly fixed to the floor. Check that the equipment has been stably installed with no rattle. 2. Column’s up and down movement: Move the column up and down to check that it moves up and down properly with no abnormal noise.
Page 133
Maintenance Services (4) Procedure 1. Set the measurement range of the Multimeter to AC (measurable range 0 ~300 V). 2. Connect the Multimeter probe between both the polarities (L (line) - N (neutral) of the power outlet. : “with load” indicates such a condition that the elevating motor or rotating arm is activated and/or X-ray is being irradiated. 6.
Disposal 8 Disposal This product cannot be disposed of as regular industrial waste. The customer is responsible for the proper disposal of this product with following the each countries'/local governments' regulation/code. For more information, please contact to your dealer. Proper Disposal of Electronic Equipment NOTE : The following information is valid in the European Union.
Patient Positioning Part 9 Patient Positioning Part Patient positioning part list Item Name Quantity Chin rest block Adaptor for edentulous jaw TMJ adaptor (Panorama) TMJ adaptor (CHILD) Bite block (consumable) (accessory) Head fixator for 3D image acquisition ( ** ) Bite plate (consumable) ( ** ) ** For equipment with 3D function Caution • Do not use any part other than those listed in the above table.
List of Periodical Replacement Parts and Consumable Replacement Parts 10 List of Periodical Replacement Parts and Consumable Replacement Parts 10.1 Periodical Replacement Parts The equipment contains no component. 10.2 Consumable Replacement Parts The equipment contains consumable stores listed in the following table. If you need to acquire any one of these consumable replacement parts, contact your dealer described at the end of this manual to provide information on your order (product name, part No.
11.1 Specification Item Specifications Digital panoramic, tomographic X-ray diagnostic equipment, arm-type Equipment type X-ray CT diagnostic equipment for dental use. Product name (Model name) X-era Smart Type number XP73 Operating mode Continuous operation with intermittent loading High-voltage generator DC rectification X-ray tube focal spot size 0.5 mm ×...
Page 138
Main Specification Item Specifications Standard image acquisition : 3D oral 58 kV, 2.0 mA: 2.0 mGy (center value), 2.0 mGy (surrounding value) Other image acquisition conditions (when the standard image acquisition is set as 1) 3D Oral Radiation dose (CTDI 71 kV, 6.3mA: 5.7 (center value), 5.7 (surrounding value) 82 kV, 10.0mA: 13 (center value), 12 (surrounding value) 3D Dental 58 kV, 2.0mA: 0.58 (center value), 0.56 (surrounding value) 71 kV, 6.3mA: 3.3 (center value), 3.1 (surrounding value) 82 kV, 10.0mA: 7.8 (center value), 6.6 (surrounding value) Linearity of X-ray output ±5% 100 μm isotropic/pixel Pixel Matrix 64 ×...
Page 139
Main Specification Item Specifications Standing position wall-mount short type: Cephalometic type: 165 kg Standing position wall-mount long type: Cephalometic type: 175 kg Standing position base-mount (with an optional base( Cephalometic type: 195 kg Standing position base-mount short type (with an optional base( Cephalometic type: 190 kg Standing position base-mount long type (with an optional base( Cephalometic type: 200 kg...
Page 140
CAN/CSA -C22.2 No. 601-1-M90 This product complies with DHHS 21 CFR Chapter I, Subchapter J at the date of manufacture. X-era Smart is in conformity with the provisions of Council Directive 93/42/EEC as amended by the Directive 2007/47/EC concerning medical devices.
Main Specification 11.10 Stray Radiation Information Stray radiation dose at the water surface at the height of X-ray focal point. 11.10.1 Dimensions of the phantom used Unit: mm 11.10.2 How To Test Set measurement points with 500 mm intervals at the front, back, left, and right of the equipment, making the rotation axis as the center.
QA (Quality Assurance) 12.3 QA Procedure (Panorama) NOTE : Perform an inspection according to the following steps every six months and save the result. Attach the Installation phantom to the chin rest block base. Installation phantom Chin rest base Acquire image of the Installation phantom under the following conditions. Image acquisition mode Standard panoramic Image acquisition status...
Page 191
QA (Quality Assurance) Check the following from the acquired panoramic images. Suppl. : Set the tomographic orbital position to “0.0 “ in Image Creator, and check the acquired image after the adjustment. 1. Check the circularity of the steel ball in the center. Radius of the X-direction should be within ±9% of the radius of Y-direction.
QA (Quality Assurance) 12.4 QA Procedure (3D) NOTE : Inspect the equipment every six months following steps below, and keep the record. Attach the 3D QA phantom to the chin rest base. Conduct image acquisition in two modes, Dental Mode and Oral Mode.
Page 193
QA (Quality Assurance) Measure aluminum disk thickness from Axial image. However, measure it without adjusting the crossbar tilt. Where to measure is described in the figure below. Measuring point is above the lower Teflon pin and below the aluminum disk center. Use the profile function to set the profile so it will be perpendicular to the Aluminum disk shown in the Axial image. Measure the width of the graph when the height of the graph is approximately 50%.
Need help?
Do you have a question about the X-ERA Smart and is the answer not in the manual?
Questions and answers