MORTIA XYZ Slice View Tomo Graph Instruction Manual

Manufacture Date: October 21, 2024
Intended Use: Diagnosis of small regions within a limited area of hard tissue of the head such as dental or ENT

Regulatory Compliance: Federal law restricts this device to sale by or on the order of a dentist

Product Usage Instructions

Safety Precautions:
- Before using the XYZ Slice View Tomograph, carefully read the user manual and follow all safety instructions provided.
Installation:
- Ensure the unit is placed on a stable surface with proper ventilation to prevent overheating.
Operation:
- Power on the tomograph using the designated switch.
- Position the patient’s head correctly for the intended scan.
- Follow the on-screen prompts to initiate the scanning process.
- After scanning is complete, power off the unit following the shutdown procedure.

Maintenance:
- Regularly clean the exterior of the tomograph with a soft, damp cloth. Refer to the maintenance section of the manual for detailed instructions.

FAQs

What is the recommended usage environment for the XYZ Slice View Tomograph?
- The tomograph should be operated in a clean and dry environment with stable temperature and humidity levels to ensure accurate imaging results.

How often should parts be replaced?
- Parts replacement frequency depends on usage intensity. It is recommended to follow the guidelines provided in the manual and conduct regular inspections to determine replacement needs.

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XYZ Slice View Tomograph

INSTRUCTIONS FOR USE

2024-10-21 Pub. No.: X055-91001-506 (en)

Thank you for purchasing the 3D Accuitomo XYZ Slice View Tomograph. For optimum safety and performance, read this manual thoroughly before using the unit and pay close attention to the warnings and notes. Keep this manual in a convienient place for easy reference.
Trademarks and Registered Trademarks: Parts of the names of companies, products, services, etc. used in this manual may contain either trademarks or registered trademarks owned by each company.
© 2008 J. MORITA MFG. CORP. i

Prevent Accidents

ATTENTION CUSTOMERS
Do not fail to receive clear instructions concerning the various ways to use this equipment as described in this accompanying Operator’s Manual. To access the warranty information for this product, scan the following QR code and visit our website.
ATTENTION DEALERS
Do not fail to give clear instructions concerning the various ways to use this equipment as described in this accompanying Operator’s Manual.
PREVENT ACCIDENTS Most operation and maintenance problems result from insufficient attention being paid to basic safety precautions and not being able to foresee the possibilities of accidents. Problems and accidents are best avoided by foreseeing the possibility of danger and operating the unit in accordance with the manufacturer’s recommendations. First thoroughly read all precautions and instructions pertaining to safety and accident prevention; then, operate the equipment with the utmost caution to prevent either damaging the equipment itself or causing bodily injury.
Note the meaning of the following symbols and expressions: This warns the user of danger of death, serious bodily injury or total equipment damage and failure or fire. This alerts the user to the risk of light to medium injury or equipment damage. This alerts the user of important points concerning operation.
The user (e.g., healthcare facility, clinic, hospital etc.) is responsible for the management, maintenance, and use of medical devices. Disregarding the information on safety is considered ABNORMAL USE.
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PRODUCT DESCRIPTION MCT-1 EX-1 F17 / EX-2 F17 is intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head and neck using cone beam computed tomography (CBCT). It consists of an X-ray source assembly, high-voltage generator, X-ray detector, data processor, reconstruction and viewer software, and patient support. The patient is scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear, nose, and throat (ENT) applications. INTENDED OPERATOR PROFILE a) Qualification:
Legally qualified person such as radiologic technician and dentists for X-ray device operation (it may differ among countries). b) Education and Knowledge: It is assumed that the user understands the risks of X-rays and the protective steps required. It is also assumed that the user is thoroughly familiar with X-ray diagnosis, anatomy, and hygiene including the prevention of cross contamination. c) Language Understanding: English (Intended for professional use as described above.) d) Experience: Experienced person with operating X-ray devices. No special training is required except in cases where this is required by legal regulations of the relevant country or region.
Use this equipment only for diagnosis of small regions within a limited area of hard tissue of the head such as dental or ENT. Caution: Federal law restricts this device to sale by or on the order of a dentist.
(valid only for U.S.A.). RELATED DOCUMENTS · Installation Instructions THE USEFUL LIFE · The useful life of the 3D Accuitomo is 10 years from the date of installation provided it is regularly
and properly inspected and maintained. · J. MORITA MFG. CORP. will supply replacement parts and be able to repair the product for a period
of 10 years after the manufacture of the product has been discontinued.
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For Safe Operation

· Judgment and caution should be used in regards to radiographs of pregnant women. The
decision should be based on “clinical need of diagnostic information”.
· When an examination requires X-ray irradiation to implantable or wearable electronic med-
ical device, the operator must take proper care after referring to the operation manual (and related safety information) for such implantable or wearable electronic medical devices because if a diagnostic X-ray device directly irradiates an implantable or wearable electronic medical device, it can cause sufficient electronic interference to affect the function and operation of the medical device.
* For reference, U.S.A. FDA published about interference with cardiac implantable electronic devices (pacemakers and implantable cardioverter defibrillators), insulin pumps, and neurostimulators on the following web site. (Accessed July 2018) Title: Interference between CT and Electronic Medical Devices URL: https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm489704.htm
· Electromagnetic wave interference could cause this device to operate in an abnormal, ran-
dom and possibly dangerous manner. Mobile terminals, smart devices, transceivers, remote controls and all other devices which transmit electromagnetic waves located inside the building should be turned off.
· Interference from the 3D Accuitomo, devices listed below might malfunction or operate in a
random, unexpected and dangerous manner. 1. Electrical diagnostic, examination or treatment devices. 2. Personal computers
· This equipment must be installed in an X-ray shield location. Local regulation for radiation
protection must be observed.
· The control box and emission button must be installed in a radiation protected area. · The X-ray protection area should consist of a wall, floor and ceiling with a minimum of
1.5 mm lead shielding or its equivalent and should have glass windows with a minimum of 1.5 mm lead shielding or its equivalent, through which the operator can observe the patient. A sign should clearly identify the area as an x-ray protection area, and a caution sign should light up during x-ray emission. Observe local regulations.
· The patient must be provided with appropriate X-ray protection gear such as lead-impregnat-
ed clothing that conforms to local regulations.
· Proper infection control procedures must be established and maintained for each patient. · It is strongly suggested that no unauthorized personnel be in the immediate area when the
equipment is in use.
· This unit is not designed for and must not be used for “fluoroscopic examinations”. · Proper radiation safety precautions must be established in accordance with local, state and
governmental regulations in regards to operator and patient protection. The ultimate responsibility lies with the owner/operator to ensure that the protection requirements of national and local codes are met.
· The operator must be able to see the exposure emissions lights and hear the audible signal
during operation of the equipment.
· The operator must be able to see and hear the patient during the operation of the equipment. · Responsible organization in medical institution needs for providing means for audio and
visual communication between the operator and the patient.
· It may not be possible to make a diagnostically useful exposure if the patient has metal fill-
ings or prosthetic devices.
· Do not use multiple portable socket outlet nor extension cord for the system power supply.
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· The EQUIPMENT should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the EQUIPMENT should be observed to verify normal operation in the configuration in which it will be used.
· This equipment must only be operated by doctors, dentists, properly licensed persons and
other legally qualified professionals.
· Use this equipment only within an x-ray protection area. · Take steps and precautions to prevent entry into the x-ray protection area during x-ray emis-
sion.
· Do not use this equipment for patients when it is being maintained or serviced. · Make sufficient space around the Main Switch so that it is easily accessible in case of emer-
gency.
· Make sufficient space around the Power distribution panel so that it is easily to breaker open
in case of emergency.
· To avoid the risk of electric shock, this equipment must only be connected to the supply
mains with protective earth.
· Do not touch simultaneously the patient and the conductive parts, such as the connector
terminals.
· The examination protocols must be created by your facility. The examination protocols are
not preloaded on the device.
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· There may be ring-shaped artifacts in the reconstructed images caused by unavoidable gain
inconsistencies in the photodiode arrays on the flat panel. Please note that these kinds of artifacts may sometimes stand out especially in the area close to the rotation center on the axial slice images and can be an obstacle in diagnosis.
· There may be some visible dots or lines on the X-ray images during image acquisition.
These lines are caused by unavoidable gain inconsistencies in the flat panel. The presence of these dots and lines does not indicate that the panel is defective.
· This equipment is suitably designed for hard tissues such as teeth and bones. It may not be
useful for soft tissue diagnosis.
· This equipment does not provide CT Numbers (required in 21 CFR 1020.33 and
IEC60601-2-44) or any equivalent values calculated from the absolute x-ray absorption of the target material.
· The x-ray images could be affected by either constant or intermittent environmental electro-
magnetic noise. This could cause image distortions or shifts that could render the obtained images useless for diagnosis.
· Quality Tests should be performed regularly once every six months (once a month recom-
mended) to maintain the conditions for adequate image performance and x-ray safety of the equipment. The test procedure is described in the Quality Tests Procedure manual that will be provided with the equipment. Other basic functions such as mechanical movements, LCD panel display and Control Panel keys should also be checked each day before use.
· CLASS 1 LASER PRODUCT: A Class 1 laser is used for the optical interface. · To use the x-ray head assembly under appropriate loading conditions, leave an interval of
approximately 5 minutes for each irradiation and leave an additional 15 minutes after every 3 irradiations.
· The rotating green circle also works as the READY key.
Be cautious of the arm rotation as it returns to the ready position when you touch this green circle.
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Parts Identification

Main Unit

Head Safety Switch Left-Right Beam Movement Unit Left Support Column Arm X Ray Head
Front-Back Beam Horizontal Beam
Headrest Chinrest Armrest Seat

Flat Panel Detector
Right Support Column Emergency Switch
Liquid Crystal Display (LCD) Control Panel
Remote Control

Base Lower, Rear of Left Support Column

Main Switch

Control Box
Emission LED Ready LED Key Switch
Main LED Hand Switch

Emission Button

Liquid Crystal Display (LCD)
Main Settings Display
· Touch the display screen directly to set conditions. (The color of a key will change when it is
pressed.) `
READY Key CTDIvol Display* Emission Time

Not Ready During Emission
FOV (Field Of View) Size Keys

Exposure Keys
Scan Rotation Keys
Imaging Modes – Standard – High Fidelity – High Resolution – High Speed
(Optional)

Tube Voltage Tube Current Patient Size

Memory Key
(Exposure conditions memory) Memorizes initial conditions

* CTDIvol (Volume CT Dose Index): Standard index for X-ray exposure Unit: mGy. Until recently, CT radiography used the index CTDIw (Weighted CT Dose Index) for a single rotation. However, in order to accommodate helical CT and MDCT, CTDIvol is now used for one entire exposure sequence. For this MCT-1 F17 unit, CTDIvol and CTDIw have the same value.

· Gently touch on the display screen by a finger. Do not press too much or poke with a stick
such as a ball-point pen. The glass may break and may cause an electrical shock.
* Scout settings display

The display shows the current settings, gives instructions, and may display an error message.

Settings Display

Example Select either CT or Scout scan.

Instructions Error Message

Example Instruction are displayed.
Example Error message appears in display.

Control Panel BEAM On / Off Key
Turn on/off the beams. READY Key Returns arm to start position. Patient IN / OUT Key Move arm to position for patients to get in or out of chair. Arm LOCK / FREE Key Locks the arm in position or frees it.
Remote Control
HEAD REST Keys Move headrest up or down.
Chair Forward / Backward Keys Move chair frontwards or backwards.

For maintenance only; not normally used.
Chair Up / Down Keys Move chair up or down.
Chair Left / Right Keys Move chair left or right. POSITION MEMORY Key Hold this key down for 3 seconds to memorize the chair’s current position. After that, the chair will move to the memorized position whenever this key is pressed.

Emergency Switch

STOP

RELEASE

Emergency Stop Distances (distance traveled after switch is pressed)

Arm Chair Vertical Chair Horizontal

10 mm (at side of head cover) 5 mm 5 mm

· In case of an emergency, press the emergency
switch and have the patient get out of the chair immediately.
In an emergency, press the emergency switch. The chair and arm will stop moving, and x ray emission will also stop.

· If the Emergency Switch or Head Safety Switch
is pressed during exposure, the image being acquired will be lost.
After Pressing Emergency Switch
Have the patient move away from the unit, and turn off the Main switch. Restore normal, safe operation in the following way. Rotate the emergency switch in the direction shown by the arrow in the illustration above. Restart the computer. Turn the Main switch back on. Check the unit operates normally and safely. If the unit is not restored to normal, safe operation, contact your local dealer or J. MORITA MFG. CORP.

Head Safety Switch
Head Safety Switch

The Head Safety Switch is activated if the patient’s head touches the arm because the chair is raised too high or the patient stands up. The chair, arm and x ray emission will all stop. Turn off the Main switch and move the patient away from the unit. To repeat the exposure procedure, turn the Main switch back on and make sure the unit operates normally and safely. If the unit is not restored to normal, safe operation, contact your local dealer or J. MORITA MFG. CORP.

· Take care that nothing like a piece of cloth used
for cleaning gets in the gap between the safety switch and the arm. This could disable the safety switch.
5

Patient Positioning Tools and Consumable Parts
a. Head Band (A) (2) b. Headrest Cushions (small) (2) c. Head Band (B) (1) d. Headrest Cushions (large) (2) e. Child Seat (1) f. Support Seat (2) g. Chinrest (1) h. Headrest (1)

Operation

Operation Procedure Float Chart
Turn computer on
Select and lock patient folder
Turn the unit on No
Check computer Yes
Press IN/OUT Key Select FOV
Have patient sit in chair
Adjust headrest height
Stabilize patient’s head
Position patient No
170 FOV Yes
Check patient’s position vis-a-vis head rotation

Select 360° or 180° CT Scan

Select Scout

Select FOV Size Select Imaging Mode Select Technique Factor Select Tube Voltage Select Tube Current

Computer

Make CT Scan

Yes Make another?

Computer Image Reconstruction

Have patient leave Turn power off.

Select tube voltage Select tube current Make scout exposure Select Image Region Click SetPos Button
No Check Yes

Set Up
* Ambient Operation Conditions: Temperature: +10°C to +30°C. Relative Humidity: 30% to 75% (without condensation). Atmospheric pressure: 70 kPa to 106 kPa.
* If an accident occurs, the equipment must not be used until repairs have been completed by a qualified and trained technician provided by the manufacturer.
* Have the patient remove glasses, necklaces, earrings and other accessories which could interfere with diagnosis.
* If the unit has not been used for some time, make sure it operates normally and safely before actually using it.
Turn Computer On
Turn the computer on. Startup the i-Dixel software. Select a patient folder from the database or make a new folder.

New

Select Patient

Choose a patient folder to data read-in.

Patient Page

* For details refer to the instructions for the i-Dixel application.
* If the computer is not on or not ready to receive image data, the following error message will appear in the unit’s LCD: “PC is not ready to receive data. Start up i-Dixel, and open the desired patient folder to prepare for data acquisition. Turn off the main power for 3DX. Wait for at least 5 seconds, and then turn it on again.”

Main switch

Turn the Unit On Turn on the Main switch, which is located on the lower back of the left support column.
The Main LED on the control box will light up, and the message, “Checking communication with the Application Software running on the destination PC.” After confirming normal communication with the computer, the unit will display the message, “Press “IN/OUT” key on the control panel.”

LCD Message

Chinrest in closed position

· If the Emergency Switch is accidentally pressed
during cleaning or for some other reason, it must be reset by turning it in the direction indicated by the arrow in the illustration before the unit will operate.
Check that only the operator is in the vicinity of the equipment and press the IN/OUT key. “CHAIR IS IN MOTION” will appear in the LCD and the seat and arm will move into position to receive the patient.
· Before pressing the In / Out Key, make sure the
chinrest is in the closed position, the position where it can be used by the patient; otherwise, the arm might hit it causing damage or an injury.
· Both the arm and chair move so make sure there
are no obstacles or body parts (fingers, toes etc.) under the step or otherwise in the way.
· If the control panel, LCD, remote control or other
switches stop working (freeze) for some reason, guide the patient away from the chair and turn the power off. Wait about 5 seconds and then turn the power back on.

Operation Check
Before operating this unit, check the following items.
· Turn the main switch on and press In / Out key. Check that the arm and the chair automatically
move into the patient entry position.
· Set the exposure conditions and hold down the emission button. Check that the arm rotates, x
rays are emitted and the buzzer sounds.
· Release the emission button and check that the x ray emission and arm rotation is terminated
immediately and also the buzzer stops. * Move the chinrest arm to the position where it is used by the patient, and adjust it to its lowest
position.
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[Operation] · In case of electrical storms, immediately let the patient out of the unit and turn off the
mains power to avoid an electric shock, fire or system damage caused by power surges. Do not touch the main unit, Control Box, computer, optical receiver or cables.
Patient Seating and Positioning
· If you decide to switch patients, start the pro-
cedure for seating and positioning from the very beginning. Otherwise, the image might not come out right, or the arm might hit the patient.
Select FOV (Field of View). * Press the 40-140 FOV key to select the 40×40, 60×60,
80×80, 100×50, 100×100, 140×50 or 140×100.

Diameter (mm) Height (mm)

FOVs (Fields of View)
Diameter (mm) 40 60 80 *
100 * 100 * 140 * 140 * 170 * 170 *

Height (mm) 40 60 80 * 50 *
100 * 50 *
100 * 50 *
120 *

* Not available for High Resolution and High Speed modes (Optional)

· Chose as small an imaging area as possible to
minimize the absorbed x-ray dosage.
· The Flat Panel Detector has two positions: one
for 40-140 FOV and another for the 170 FOV. Therefore, it may move when the FOV is selected. In this case, a message will appear in the LCD. Take appropriate safety steps. For 40-140 FOVs * Select the 170 FOV. Selecting 170 is done later (page 28). Select 40-140 FOV.
The patient seating procedure will appear in the control panel’s LCD.
13

Open

Patient Seating
(1) Seat the patient on the chair.
Have the patient put on x-ray protection gear and sit down.
First adjust Chinrest to its lowest position, and then open the Chinrest arm to allow the patient to enter.

· Avoid pinching body parts; wait until everything
stops moving before have the patient sit in or get out of the chair.
· Make sure no body parts are pinched by mov-
ing parts. Watch the area between the arm and support columns, the headrest, the chinrest, the slide mechanism for the flat panel detector and under the foot step.
· Keep an eye on the patient and the equipment
when it is moving. In case of an emergency, stop the equipment by pressing any key on the remote control except the position memory key. (Keys in the display cannot be used to stop the chair in an emergency.)
· Always try to maintain contact with the patient
visually and auditory to ensure safe operation of the unit.
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Child Seat

* Use the auxiliary seats if the patient’s head does not reach the headrest.

Support Seat
Forward / Backward Close Up / Down

After the patient sits down, swing the chinrest in front of him/her. Be careful not to hit the patient with it.
The chinrest can be moved up or down and backwards and forwards to line up with the patients chin.

Up Down Tighten Loosen

Forwards / Backwards

· If both the chair and the chinrest are too high, the arm could hit the chinrest. Before mak-
ing an exposure, press the Lock / Free key to free the arm and then carefully rotate it manually to make sure it will not hit the chinrest.
· Do not lean on or put excessive weight on the chinrest. It may be damaged which may
result in injury.
· Take care not to injure the patient when adjusting the chinrest.

· Take care not to pinch your fingers or the patient’s fingers in the chinrest’s slide mecha-
nism, knobs, or other moving parts.
· Never try to move the arm when it is locked; this could damage it and will cause an error
message to appear.
· Even when the arm is free, rotate it carefully, slowly, and safely.
15

Proper Seated Position
Hands on armrests Feet in center of step
Support Seat Hands on armrests With auxiliary seat

* If the armrest is in the way, pull it out slightly and then lower it.
· After the patient sits down, do not fail to raise
the armrest back up.
Seated Position Have the patient sit all the way back in the chair with his/her head up against the headrest, hands on both armrests to prevent scrunching up of his/her shoulders, and feet together in the center of the step. Before Moving the Chair Tell the patient you are going to move the chair. While Chair is in Motion Make sure patient’s hands and feet are properly positioned.
· Have the patient place his/her hands on the
armrests. Do not allow him/her to touch the other parts of the equipment, such as the arm, headrest, chinrest, support columns, control panel, or remote control.
Children If necessary use one or both auxiliary seats for children. Make sure they are sitting in the right position.
· When using an auxiliary seat, tell the patient
not to move or wiggle. The seat could slide or slip and cause an injury.
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Headrest

(2) Adjust the height of the Head Rest.
Use the headrest keys on the remote control to adjust its height. (The lower edges or the sides of the headrest should generally be about 2 mm above the ears.)
Headrest Keys

Head Band (A)

(3) Gently secure the patient’s head with the Head Band.
Fix the head band on with the Velcro tape; don’t make it too tight. Put the 2 cushions on the head band and position them against the temples as shown in the illustration.

Head Band (A)

Cushions (small)
Head Band (B) C

Cushions

Tab

(large)

After putting on the child’s head band, pull on the tabs to tighten it up so that there is firm contact at points A, B, and C in the illustration.
17

Chinrest

(4) Adjust the Chin Rest so that it touches the patient’s chin.
Adjust the position of the chinrest and have the patient lightly rest his/her chin on it.
· Never move the headrest after adjusting the
head band or chinrest. It may result in injury to the patient.
· Do not lean on or put excessive weight on the
chinrest. It may be damaged which may result in injury.
· Adjust the chinrest carefully without injuring the
patient.
· Take care not to pinch your fingers or the pa-
tient’s fingers in the chinrest’s slide mechanism, knobs, or other moving parts.
Press Next. A message will appear and the chair will move to the approximate imaging position. Then the next steps in the positioning procedure will appear in the display.

· The arm and chair will move. In case of an
emergency press the emergency switch, any key on the control panel or any key on the remote control except the position memory key. (Keys in the display cannot be used to stop the arm and chair in an emergency.)
(* Refer to page 11 for how to restore normal working order after pressing the emergency switch. If you stopped the unit by pressing some other key, press the Ready key to restore normal operation.)
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Patient Positioning

Cushions Head Band

· The laser beam could damage a person’s eye-
sight; never look directly into the beam and let it strike anyone’s eyes.
Have the patient rest the back of his/her head straight against the center of the headrest, pull in his/her chin, and straighten his/her back as much as possible. The patient’s Frankfort plane should be parallel to the floor, and the Left-Right beam should be lined up with the patient’s mid-sagittal plane. Tighten up the head band and make sure the patient’s head is sufficiently stabilized.

Left-Right Beam

* If the Left-Right beam will not line up with the patient’s mid-sagittal plane, adjust the cushions until it
does.

* The beams turn off automatically after 1 minute. Press the Beam Key on the control panel to turn
them back on.

Horizontal Beam Front-Back Beam

Adjust the chinrest so that the patient’s chin rests easily on it. Check that the patient’s head is stabilized by the chinrest.
· Do not lean on or put excessive weight on the
chinrest. It may be damaged which may result in injury.
· Adjust the chinrest carefully without injuring the
patient.
· Take care not to pinch your fingers or the pa-
tient’s fingers in the chinrest’s slide mechanism, knobs, or other moving parts.
(1) Adjust the chair height to set the Horizontal beam at the region of interest.
Use the keys on the remote control so that the lines up with the center of the imaging area.
· Never move the headrest after adjusting the
head band and chinrest. It may result in injury to the patient.
(2) Adjust the chair position to set the Front-Back beam at the region of interest.
Use the keys on the remote control to move the chair so that the Front-Back beam lines up with center of the imaging area.
· The final imaging position must be reconfirmed
visually by the positioning beams before exposure. (Do not rely only on scout positioning or the information on the display).
20

Press Next. The chair position will be memorized and
the Ready LED on the control box will light up. The main settings display will appear in the control panel.

Main Settings Display

Press “CT” to make a CT image. Press “Scout” to make a scout image. (See page 40)

For FOV 170×120 Exposures Select FOV 170. * Except for selecting “170”, the part of patient seating
procedure is the same as for FOV 40-140. Follow procedures for FOV 40-140 (pages 19 24).
· In High Resolution and High Speed modes (op-
tional), only 40×40 FOV and 60×60 FOV are available.
· The arm and chair will move. In case of an
emergency press the emergency switch, any key on the control panel or any key on the remote control except the position memory key. (Keys in the display cannot be used to stop the arm and chair in an emergency.) (* Refer to page 11 for how to restore normal working order after pressing the emergency switch. If you stopped the unit by pressing some other key, press the Ready key to restore normal operation.)
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Horizontal Beam Front-Back Beam

Patient Positioning (1) Adjust the chair height to set the Horizontal beam
at the region of interest. Use the keys on the remote control so that the lines up with the center of the imaging area.
· Never move the headrest after adjusting the
head band and chinrest. It may result in injury to the patient.
(2) Adjust the chair position to set the Front-Back beam at the region of interest.
Use the keys on the remote control to move the chair so that the Front-Back beam lines up with center of the imaging area.
· The final imaging position must be reconfirmed
visually by the positioning beams before exposure. (Do not rely only on scout positioning or the information on the display).

Ensure the patient positioning and press “Next”

Free the arm and rotate it carefully so that the arm does not hit the patient.

Arm
Slowly !

Check Patient Positioning (1) Slowly rotate the Rotation Arm manually. (2) Check that the Flat Panel does not contact the
patient’s shoulder, the chin-rest or the head-rest during rotation.
Do this carefully so that the arm does not hit the patient. Free the arm and rotated it manually. * The arm might hit something so rotate it slowly and
carefully.
If the arm hits something use the remote control key to adjust the chair height, or press the In / Out key and select a different FOV.
· Never try to move the arm when it is locked; this
could damage it and will cause an error message to appear.
· Even when the arm is free, rotate it carefully,
slowly, and safely.
24

· To lock the arm, press the Lock / Free key while
the arm is standing still. Press the same key again to free the arm.
· To put the unit into Ready mode when the arm is
free, press the Ready key while the arm is standing still.

Chair Up / Down Keys

(3) If it does, try lowering the chair as far as imaging requirement permits.
Adjust the height of the chair with the Up / Down keys on the remote control so that the arm will not hit the patient.

(4) If it still hits something, this FOV cannot be used. Press the “IN/OUT” key to select a smaller FOV.
If proper adjustment is troublesome or not possible, press the In / Out key and select a different FOV.
· Watch out for the chair’s movement when you
press the In / Out key to select a different FOV.

Press Next. The chair position will be memorized and
the Ready LED on the control box will light up. The main settings display will appear in the control panel.

Main Settings Display

Press “CT” to make a CT image. Press “Scout” to make a scout image. (See page 40)

CT Exposure Settings

1. Select CT exposure

2. Select scan rotation (180°/ 360°)

5. Set Tube Voltage 6. Set Tube Current

4. Select Preset Technique Factor

3. Imaging Modes * – Standard (Std) – High Fidelity (Hi-Fi) – High Resolution (Hi-Res) – High Speed (Hi-Speed)
7. Memory Key (Exposure conditions memory. Sets initial conditions when unit is turned on.)

* Touch the display screen directly to set conditions. (The color of a key will change when it is pressed.)
* High Fidelity, High Resolution and High Speed modes are optional.

· If the X-rays are too strong and pass through some material such as air that has very low
absorption, the detector in that area will be saturated. In the resulting image, the saturated area may falsely appear to entirely lack any tissue whatsoever. To make an accurate diagnosis, one should carefully watch the image produced during the exposure to identify saturation areas.
· Gently touch on the display screen by a finger. Do not press too much or poke with a
stick such as a ball-point pen. The glass may break and may cause an electrical shock.

1. Press CT. 2. Press 180° or 360°.

3. Imaging Mode. Select the Imaging Mode.
– Standard (Std) mode 17 second scan for all applications.
– High Fidelity (Hi-Fi) mode – optional
30 second scan for lower noise, better contrast resolution especially at peripheral area of an image, good for zoom reconstruction and volume rendering.
– High Resolution (Hi-Res) mode – optional Higher spatial resolution for limited imaging area up to 60×60 FOV by using smaller pixel mode of the flat panel detector.
– High Speed (Hi-Speed) mode – optional High speed rotation in 10 seconds for full scan, up to 60×60 FOV. It helps reduce motion artifact during scan.

4. Select the FOV (field of view).

* Refer to page 36 for how to change a FOV 40-140 setting to FOV 170.

a a. Press the FOV key to display the FOV selec-

tions (40×40, 60×60, 80×80, 100×100, 140×100,

170×120, 100×50, 140×50, or 170×50).

(Only 40×40 and 60×60 for High Resolution and

High Speed modes, optional)

b. Press the key for the desired FOV.

· In High Resolution and High Speed modes (op-
tional), only 40×40 FOV and 60×60 FOV are available.
28

5. Select the Technique Factor. a. Press the Technique Factor. b. Select Lo, Mid, or Hi. c. Hold the Param.Memory key down for 2 seconds.
6. Set tube voltage. (1) Press the Tube Voltage key. (2) Up and Down keys will appear; press them to set the voltage (60 to 90 kV ). (3) Press the Tube Voltage key again.
7. Set tube current. (1) Press the Tube Current key. (2) Up and Down keys will appear; press them to set the current (1 to 10 mA ). For High Fidelity and High Resolution modes (optional), the maximum selectable tube current is limited to 8 mA. (3) Press the Tube Current key again.
* Recommended: 90 kV and 4 to 6 mA.
· In High Fidelity and High Resolution modes (op-
tional), the maximum selectable tube current is limited up to 8mA.
8. Press the Param.Memory key to save the current settings as those that will appear when the unit is turned on. Hold the Param.Memory key down for at least 2 second to memorize the tube voltage and current for the currently selected scan mode and Technique Factor.
29

To Change the FOV
· Follow the message in the display to change
from a 40-140 FOV to a 170 FOV or vice versa.
· The chair may move when the FOV is changed.
i) Change from a 40-140 FOV to a 170 FOV To select the 170 FOV, press the “IN/OUT” key and start over from the FOV Selection. Press “Back” to return to the procedure for a 40-140 FOV exposure.
ii) Change from a 170 FOV to a 40-140 FOV After this change is made, it is not possible to go back to the 170 FOV settings. Press “Next” to change to a 40-140 FOV. Press “Back” to continue with the procedure for a 170 FOV.
No X Ray Setting Use this to check the arm’s rotation without emitting any x rays. Set the tube voltage or the tube current for 0. You may now check the arm’s rotation to make sure it will not hit the patient or anything else. To return to normal operation, simply reset the tube voltage and current to their normal values.
30

On
Emission Button Hand Switch
X Ray Emission Status Off

CT Exposure
Make sure the Ready LED on the control box is on. Press the Ready key if it isn’t.
Insert the key and turn it to the right.
Pick up the hand switch and hold down the emission button. X ray emission will begin and be signaled by a melody. Also the control box’s buzzer will sound and the emission LED on the control box will light up. (Also the Ready key in the display will change to its x ray emission status.) Release the emission button when the buzzer stops sounding. Hang the hand switch back up on the control box. And turn the Key to the left and take it out.
During emission, the x ray penetration image will appear in the computer monitor.
· If the X-rays are too strong and pass through some
material such as air that has very low absorption, the detector in that area will be saturated. In the resulting image, the saturated area may falsely appear to entirely lack any tissue whatsoever. To make an accurate diagnosis, one should carefully watch the image produced during the exposure to identify saturation areas.
· For the 170 FOV, the flat panel detector passes
quite close to the patient. Watch carefully and make sure it does not hit him/her.
· Leave the x ray booth, and hold the emission but-
ton down outside of it.
· In case of an emergency release the emission
button or press the emergency switch. Guide the patient away from the unit as soon as it stops moving.
· Wear appropriate x-ray protection gear such as
lead-impregnated clothing when remaining in the x-ray protection area during exposure from unavoidable circumstances.
· High Fidelity and High Resolution modes (optional)
require a longer exposure time to complete a scan. Use these modes only when necessary.
· The rotation arm moves quickly in High Speed
mode (optional). Pay special attention to the arm rotation not to pinch or hit against any parts of body or other objects including the chin-rest and head-rest.

· Warn the patient not to move while the melody is playing. Otherwise, the arm might hit
him/her and spoil the image.
· Hold down the emission button until the exposure has been completed. If you release it
too soon, x ray emission will stop and the image data will be lost.
31

· If the 3D Viewer is running when x ray emission is initiated, it will close automatically, and
the i-Dixel application will return to the Image List screen.
· If the image in the 3D Viewer has been edited or modified, this data will be saved.
· If the saved data is not needed, delete it manually after the x ray emission is over.
Refer to the user manual for the i-Dixel application for how to delete the data.

Image transmission in progress

Image Reconstruction
After x ray emission, the image data will be sent to the computer and the i-Dixel software will automatically begin to process it. The message “Reconstruct volume?” will appear.
Click “No” to wait until later to reconstruct the image.
Click “Yes” to reconstruct the image immediately. After processing, the XYZ slice window will open.

* Image reconstruction takes from 3 to 20 minutes depending on the FOV and the computer’s processing speed.
* Refer to the user’s manual for the i-Dixel software for details concerning various image processing procedures such as reslicing, volume rendering, and 3D imaging.

Scout Exposure Settings [Positioning for Scout Exposure] For 40-140 FOV, check the location of the laser beams. * Making a Scout image simplifies the procedure for making a CT scan.
The Scout appears as two images at different angles. Select a point in the two-direction scout to fix the center of the FOV. The arm and slit for the x ray beam will automatically move accordingly.
· The scout function is only used as a reference in positioning. The absolute accuracy of
positioning is not guaranteed.
· Do not close the scout window until the CT exposure has been completed.
Once the scout window has been closed, it can no longer be used for positioning.
· The accuracy of the scout is ±3 mm.
1. Select Scout exposure

2. Set Tube Voltage 3. Set Tube Current

4. Memory Key (Exposure conditions memory. Sets initial conditions when
unit is turned on.)

· Gently touch on the display screen by a finger. Do not press too much or poke with a
stick such as a ball-point pen. The glass may break and may cause an electrical shock.
33

1. Select Scout exposure mode.
2. Select the FOV (field of view) a. Press the FOV key to display the FOV selections (40×40, 60×60, 80×80, 100×100, 140×100,170×120). b. Press the key for the desired FOV. FOV cannot be changed from 170FOV to 40-140FOV or vice versa. Start from IN/OUT FOV size of Scout Exposure is always equal to or larger than that of CT Exposure. FOV size of CT Exposure may be automatically changed depending on the FOV size of Scout Exposure selected.
3. Set Tube Voltage (1) Press the Tube Voltage key. (2) Up and Down keys will appear; press them to set the voltage. (60 to 90 kV ). (3) Press the Tube Voltage key again.
4. Set Tube Current (1) Press the Tube Current key. (2) Up and Down keys will appear; press them to set the current. (1 to 10 mA ). (3) Press the Tube Current key again.
* Recommended: 80 kV and 2 or 3 mA.
5. Press the Param.Memory key to save the current settings as those that will appear when the unit is turned on. Hold the Memory key down for at least 2 second to memorize the current tube voltage and tube current.
34

Scout Exposure

Make sure the Ready LED on the control box is on. Press the Ready key if it isn’t.

Insert the key and turn it to the right.

Emission Button
Hand Switch X Ray Emission Status
Off

Pick up the hand switch and hold down the emission button. X ray emission will begin and be signaled by a melody. Also the control box’s buzzer will sound and the emission LED on the control box will light up. (Also the Ready key in the display will change to its x ray emission status.)
* Hold down the emission button until two exposures are completed (until the melody stops playing). Release the emission button after the second emission buzzer stops sounding completely. Hang the hand switch back up on the control box. And turn the Key to the left and take it out.
· Leave the x ray booth, and hold the emission
button down outside of it.
· In case of an emergency release the emission
button or press the emergency switch. Guide the patient away from the unit as soon as it stops moving.
· Wear appropriate x-ray protection gear such as
lead-impregnated clothing when remaining in the x-ray protection area during exposure from unavoidable circumstances.
· Warn the patient not to move while the melody
is playing. Otherwise, the arm might hit him/her and spoil the image.
· Watch out for the chair’s motion when the scout
exposure is made.
· Hold down the emission button until the second
exposure is completed. If you release it after the first exposure, all the image data will be lost.

Image transmission in progress

After x ray emission, the image data will be sent to the computer and the i-Dixel software will automatically begin to process it.
* For the 40-140 FOV, an unexposed area will appear around the scout image.

Select imaging area

· If you click on the image repeatedly or drag the
box around for a long time, the computer’s react may slow up and freeze.
· Do not press any of the keys on the control panel
as long as the box for selecting the image area appears in the computer monitor. The keys could become disabled.
The two scout images will appear in the computer monitor. The red and yellow lines pass through the center of the imaging area, and the green box indicates the size of the area. Drag the lines or the point where they intersect to select the CT imaging area. * Check the control panel display and make sure it is
set for a scout exposure.
Once you have selected the imaging area, click the SetPos button on the tool bar. A plus mark will appear at the centers of the imaging areas shown in the scout images, and a message will appear in the display on the control panel concerning patient positioning.
· Click SetPos button after changing the cursors,
otherwise the cursor position will not be sent to the device to set the CT position.
· If the device is in an error state, SetPos infor-
mation will not be sent to the device to set the CT position and the center position “+” marks will not be displayed on the screen. Restore the device from the error state and set the scout position again by SetPos button, or restart from another scout scan.
36

If you click Yes, the unit will sound a two-toned beep and a buzzer. The arm and chair will move into their positions, and a new message will appear in the display on the control panel. Click No, if you wish to repeat the scout image or select another type of exposure
If you drag a cursor outside the imaging range, it will turn red and a message will appear in the control panel display saying that the setting is out of range.
37

Change FOV with i-Dixel software Click the CT Area button. A dialogue box will appear.
Click the pull down triangle, select the FOV size, and then click OK.
· The 170 FOV cannot be selected if the unit is
already set for 40-140. A beep will sound and the size of the area will change.
· Never take your eyes off the patient during a
scout scan. In case of an emergency, stop the chair by pressing the emergency switch, any key on the control panel or any key on the remote control except the position memory key. (Keys in the display cannot be used to stop the chair in an emergency.)
· When you’ve finished positioning the patient,
perform a final visual confirmation using the three position beams.
· If the beams have gone off, turn them back on
with the Beam On / Off key.
38

Patient Egress Warn the patient that the chair will move and make sure the area is free of obstacles. Press the In / Out key on the control panel.
· The arm and chair will move. In case of an
emergency press the emergency switch, any key on the control panel or any key on the remote control except the position memory key. (Keys in the display cannot be used to stop the arm and chair in an emergency.) (* Refer to page 11 for how to restore normal working order after pressing the emergency switch. If you stopped the unit by pressing some other key, press the Ready key to restore normal operation.)
A message will appear in the display, and the chair and arm will move to the patient egress position.
The Ready LED on the control box will start blinking on and off. Move the chinrest, remove the headband, and guide the patient away from the unit.
39

After Use Turn the main switch off.
Turn off the main switch located on the lower part of the back of the left support column.
· Do not fail to turn off the main switch. This elim-
inates the risk of electrical leakage and accidental operation. The power LED will go out.
40

Automatic Cooling Intervals of X-Ray Head

· To use the x-ray head assembly under appropriate load conditions, leave an interval of
approximately 5 minutes for each irradiation and leave an additional 15 minutes after every 3 irradiations.
After each irradiation, the system will automatically leave a short interval calculated from the amount of energy based on the current settings of tube voltage, tube current and scan time to cool the x-ray tube down. Also, after every 4 irradiations, the system requires an additional cooling time of 15 minutes in order to cool down the x-ray head and high voltage circuit.
When one scan is completed, a green circle and “Remaining Time” will appear at the top of the LCD panel. While the green circle is rotating, the remaining time counts down. When the remaining time reaches zero, the circle will change to “Ready”.
The green dots below the green circle indicate the remaining number of irradiations allowed before a longer cooling interval is required. For example, when there are three dots shown, there are three irradiations possible before the 15-minute cooling interval.

Remaining number of irradiations allowed before the long 15-minute cooling interval

· The rotating green circle also works as the
READY key.
Be cautious of the arm rotation as it re-
turns to the ready position when you
touch this green circle.

As shown in the figure on the left, there is only one orange dot left in the indicator. This means that there is only one irradiation remaining before the longer cooling interval. After the last irradiation, you must wait for 15 minutes for the system to cool down and be ready for the next set of irradiations.

The default cooling intervals applied are automatically calculated from the minimum requirements of the related components. Regardless of the default cooling intervals, please try to leave as much time as possible between irradiations to ensure the system will continue to provide good quality images for the longest possible time.
41

Maintenance, Parts Replacement, and Storage

Maintenance [Daily Maintenance] Disinfect the control panel, remote control, headrest, armrest, chinrest, seat, auxiliary seat, headband, and headrest cushion after each patient by wiping them with ethanol (70 vol% to 80 vol%). Wipe the operation panel with ethanol (70 vol% to 80 vol%). If it is not possible to obtain ethanol (70 vol% to 80 vol%), use one of the disinfectants listed below; do not use any other type of disinfectant.
· DÜRR DENTAL’s FD 322 quick disinfectant · DÜRR DENTAL’s FD 333 quick disinfectant · DÜRR DENTAL’s FD 360 imitation leather cleaning and care · DÜRR DENTAL’s FD 366 sensitive Rapid disinfection
· Always turn off the main switch before you perform maintenance work. This is necessary
to avoid getting an electrical shock or burn, as well as to prevent the CT unit from sudden operation through inadvertent contact with a switch or similar action.
· Never remove the covers of the CT unit.
· Use only ethanol (70 vol% to 80 vol%) or a neutral detergent to clean outer surfaces. Nev-
er use alkaline or acidic solutions, cresol soap, or other chemical solutions; this could cause discoloration or degrade the materials.
· If any water, detergent, cleaning solvent, or other chemical solutions get on the outer sur-
faces, wipe them off immediately with ethanol (70 vol% to 80 vol%).
· Do not use ozone water to clean the unit. Ozone water could damage to the unit. · Do not disinfect the clinic with ozone gas or ultraviolet light. This could damage plastic
and rubber components.
· When cleaning the unit with ethanol (70 vol% to 80 vol%), take care that none of it seeps
inside; this could damage the unit.
Parts Replacement
* Replace the parts as necessary depending on degree of wear and length of use. For details, see page 45 “Service Life, Consumables, and Replacement Parts”.
* Order replacement parts from your local dealer or J. MORITA OFFICE.
Storage
* Ambient Storage Conditions: Temperature: -5°C to +43°C (+23°F to 109.4°C) Humidity: 8% to 85% (without condensation) Atmospheric Pressure: 70 kPa to 106 kPa No frequent or continuous exposure to direct sunlight.
* If the unit has not been used for some time, make sure it works properly before using it again.
42

Regular Inspection

· Maintenance and inspection are generally consider to be the duty and obligation of the user, but if,
for some reason, the user is unable to carry out these duties, he/she may rely on a qualified medical device serviceman. Contact your local dealer or J. MORITA MFG. CORP. for details.
· This unit should be inspected for all the items in the following list once a year. · At the start and end of each business day, make sure that switching the main switch to ON and OFF
turns the equipment on or off without fail.
· The inspection items marked * may only be performed by the service personnel for furether preven-
tive inspection and maintenance during the life of the device.
· For repair or other types of service contanct your local dealer or J. MORITA MFG. CORP.
Daily Inspection

Item

1 Main Power

Remote control of the chair and headrest

Data acquisition monitoring and slice image creation

4 Arm Rotation

5 Warning messages

6 Hard Disk Space

Description
Check that the power turns on and off when the key switch is turned on and off
Make sure the remote control moves the chair and headrest properly and that there is no abnormal noise or vibration etc.
Make sure the acquisition of the image data is being properly monitored by the software. Make sure data is reconstructed and slice images are created.
No abnormal noise, vibration etc. during CT scan
Make sure no warning messages appear when the computer is turned on or at other times.
Make sure there’s enough empty space on the hard disk

Regular Inspection List

Troubleshooting

If the equipment operation does not seem to be normal, check or adjust the following before requesting a repair service.
· If the equipment does not operate properly after the inspection, adjustment, or parts replacement
or if you cannot perform the inspection yourself, contact your local dealer or J. MORITA MFG. CORP.
· The inside parts of the equipment are charged with high voltage. Do not attempt to perform main-
tenance or adjustment that is not described in the troubleshooting table.
· If an accident occurs, the equipment must not be used until repairs have been completed by a
qualified and trained technician provided by the manufacturer.
· Contact your local dealer or J. MORITA MFG. CORP. for repairs if the apparatus does not work
normally even after performing the steps recommended below. <Error and operation messages that might appear in the LCD>
This is displayed when the user specifies an area outside the range of chair movement for a two-direction scout scan. Check the selected scan area again.
This is displayed when the PC is not ready. After confirming that the PC is on and the program is up and running, press any key on the control panel or remote control. If the system cannot be restored, temporarily turn off the power. After confirming that the PC is ready, restart the CT unit.
This is displayed when an abnormality has been found in the X-ray generator circuit. Stop using the CT unit and contact your local dealer or J. MORITA MFG. CORP.
47

This is displayed when the emergency switch has been actuated. Turn off the power, and after waiting five seconds or more, turn it back on again. If the CT unit still cannot be restored, stop using the unit and contact your local dealer or J. MORITA MFG. CORP. directly.
This is displayed when the X-ray head is overheated. Leave the CT unit on and wait at least 30 minutes until the unit cools. Leave enough time between exposures for the x ray tube and high voltage circuits to cool off.
Number: 9, 11 (The same message will be shown for either error number.) The protection circuit activated, as a temporary discharge detected in the X-ray tube. Turn off the power, and after waiting five seconds or more, turn it back on again. If the CT unit still cannot be restored, stop using the unit and contact your local dealer or J. MORITA MFG. CORP. directly.
This is displayed when the PC is not ready or there is a problem with the connection with the PC, or when the optical receiver is not turned on. Check the PC, cable connections, and the power for the optical receiver.
48

This is displayed when the PC is not ready or the driver software is busy processing image data. After confirming that the PC is on, the program is up and running, and that the driver software is not busy, press the Ready key. Otherwise, restart the program and turn the power to the CT unit briefly off and then back on again.
This is displayed when automatic movement of the chair is stopped through pressing of a key on the control panel or remote control. To restore, confirm that there is no danger to the patient and press the Ready key. If positioning by scout scan is underway, press the Ready key and be sure to specify the scan area again on the PC.
This is displayed when a problem has been found in communications with the motor controller of the rotation arm. Press the Ready key on the control panel. If the CT unit cannot be restored, temporarily turn off the power to the CT unit and then restart. If the CT unit still cannot be restored, stop using the unit and contact your local dealer or J. MORITA MFG. CORP. directly.
This is displayed when abnormal operation of the arm motor has been detected. If continuing operation involves a risk, ask that the patient exit the CT unit, and turn the power briefly off and then on to check for any abnormality in the CT unit. To restore, confirm that there is no danger to the patient and press the Ready key.
49

If continuing operation involves a risk, ask that the patient exit the CT unit and turn the power briefly off and then on to check for any abnormality in the CT unit. To restore, confirm that there is no danger to the patient and press the Ready key.
This is displayed when a scan has been aborted by the operator. In this case, only a partial image can be processed. When you press the Ready key, the chair returns to its home position, and the CT unit is restored to the normal operating state.
This is displayed when an error has been found in the backup data (initial setting data) stored in the CT unit. To avoid danger, automatic positioning in the direction of height and chair-position memory can no longer be used. Since in this case inspection and adjustment are required, please contact your local dealer or J. MORITA MFG. CORP. directly.
This is displayed when an error has been found in the collimator that limits the X-ray irradiation area. The correct radiation field may not be selected. Since in this case inspection and adjustment are required, stop using the CT unit and contact your local dealer or J. MORITA MFG. CORP. directly.
50

Problem with chair remote control transmission. Press the Ready key. If this does not solve the problem, turn the unit off and then try again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
51

Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. Guide the patient away from the unit. Turn main power off. Wait for 5 seconds. Turn power back on again. If this still does not solve the problem, stop using the unit and contact J. MORITA MFG. CORP. or your local dealer.
Anomaly detected for chair movement. If continued use presents some danger, Guide the patient away from the unit. Turn main power off, and then turn it back on again. Make sure the unit is operating normally and safely. If normal operation has been restored, check that the unit is safe for the patient and press the Ready key.
52

Anomaly detected for chair movement. If continued use presents some danger, Guide the patient away from the unit. Turn main power off, and then turn it back on again. Make sure the unit is operating normally and safely. If normal operation has been restored, check that the unit is safe for the patient and press the Ready key.
Anomaly detected for chair movement. If continued use presents some danger, Guide the patient away from the unit. Turn main power off, and then turn it back on again. Make sure the unit is operating normally and safely. If normal operation has been restored, check that the unit is safe for the patient and press the Ready key.
Scout scan was not completed. The second exposure was cancelled by releasing Emission Button after the first exposure. Emission Button must be kept pressed until the second exposure is completed. Press READY key and retry scout scan.
Scout scan was interrupted during the second exposure. Emission Button may have been released before the second exposure is completed. Press READY key and retry scout scan. If this error still occurs even though Emission Button is kept pressed, stop using the unit and contact J. MORITA MFG.CORP. or your local dealer.
53

There is some problem with the back-up or teaching data.
This requires inspection and adjustment. Contact J. MORITA MFG. CORP. or your local dealer.

CT position selected by Scout scan is cancelled when the chair position is moved manually by Remote Control. Press READY key and start from selecting the CT imaging area on the PC again, or taking another scout scan.
CT scan can be taken at the position manually selected by Remote Control. However, the link from the scout image to the CT image will be cancelled and the CT image can not be opened from the scout image.There is some problem with the back-up or teaching data. This requires inspection and adjustment. Contact J. MORITA MFG. CORP. or your local dealer.

Problem

Conceivable Cause

Solution

· Lines are superimposed on the image.
· A part of the image is lost.
· The image is entirely black.

* Noise may have been introduced.

One of the following symptoms is encountered:
· While in use, the unit behaves the same way as it does when it first turns on.
· The switch does not work.

* The power supply may have been momentarily
interrupted.

Temporarily turn the power off, and after confirming that the patient and the user are in a safe place, turn it back on again and ensure that the CT unit operates normally.
Make sure the power used for the CT unit is 120 VAC with a capacity of 20 A for EX-1, 220/230/240 VAC with a capacity of 10 A for EX-2 or more and supplied from a single, devoted circuit, and that the power is properly grounded. During scanning, do not use any other device in the vicinity that may generate noise.

7. Cautionary Remarks on Imaging
Artifacts Due to Sensitivity Discrepancies of the Flat Panel Detector
The flat-panel detector (FPD) is an extremely dense and precise array of photo diodes (pixels). By compensating for the discrepancy in pixel sensitivity, the image can show greater detail than ordinary fluoroscopy. However, this discrepancy cannot be completely eliminated when a CT image is reconstructed. To make a CT image, the X-ray beam rotates around the object and produces a fluoroscopic image. Points away from the center of the imaging area move on the imaging surface depending on the angle of their projection. This tends to even out the fluctuations in sensitivity, but it does not completely eliminate them. (See Fig. 1.) Therefore, artifacts can appear near the center of the imaging area as shown in Fig. 2. The appearance of these artifacts depends somewhat on the exposure conditions and the X-ray transparency of the object. To make a detailed analysis and precise diagnosis, the radiologist must carefully take into consideration the possibility and nature of artifacts.

Rotation

Focal Point Imaging Surface

Center is always projected onto the same area of the imaging surface regardless of the angle of projection.

Note: View from above the plane of rotation

A point near the center is projected onto different places on the imaging surface depending on the angle (i.e., it moves on the imaging surface).

Fig. 1 Principle of CT Exposure

Fig. 2 Example of an Artifact 56

Artifacts due to Metal Prosthetics Useful images may not be possible if a patient has metal fillings or prosthetic devices, and it is usually impossible to make a useful image of a crown if it is right next to a metal prosthetic. Also it is sometimes impossible to make useful images of a root or jaw bone if there is a metal post, crown or other prosthetic right next to it. Photos 3 through 9 were made of a mandible model with various metal prosthetics, posts and canal fillings to demonstrate what needs to be taken in consideration for accurate diagnosis and analysis.
Photo 3 Model of full metal crown. (Top of crown was removed and replaced with a piece of lead.)
57

Image Area
Photos 4 No metal Prosthetic (Top: Model and Image Area. Bottom: Images.)
58

Image Area Metal Prosthetic
Photos 5 Full metal crown is on the opposite side of the image area. (Top: Model and Image Area. Bottom: Images.)
59

Image Area Metal Prosthetic
Photos 6 Imaging area on same side as metal crown (Top: Model and Image Area. Bottom: Images.) 60

Photos 7 Post and Crown Left: Post and Crown made after filling root canal with gutta percha and
point. Center: Post and Crown attached to tooth. Right: Simple dental x ray.
61

Image Area Post and Crown
Photos 8 Image area on opposite side. (Top: Model and Image Area. Bottom: Images.)
62

Image Area Post and Crown
Photos 9 Image area on same side (Top: Model and Image Area. Bottom: Images.)
63

Artifacts for 180° Exposures
For 180º exposures, when the X-ray beam passes through the lower plane (a) in Figure 10, the result is the flat shape shown in Figure 11, where the beginning of 180º circuit matches the end of the circuit. However, when the X-ray beam passes through the upper plane (b) in Figure 10, the result is the conical shape shown in Figure 12, where there is a discontinuity between the beginning and end of the circuit.
Therefore, some slight streaking appears in a 180º exposure that does not appear in a 360º exposure (Figure 13). These streaks run in the direction of the rotation. As a result, some semi-circular artifacts appear in the Z-plane image, and these must be recognized and taken into consideration for accurate diagnosis and analysis.

b a
Fig. 10

Continuous

a Beginning

X Ray Beam

X Ray Beam
End
Fig. 11

b Beginning

X Ray Beam X Ray Beam

Discontinuous
End
Fig. 12

Fig. 13

8. Technical Specifications

Specifications
Model Type

MCT-1 EX-1 F17 / EX-2 F17

Classification
Protection against electric shock Protection against ingress of liquids Type B applied parts

CLASS I, TYPE B
IPX0
Headrest, Chinrest, seat, and headband (no conductive connection to patient)

Disinfection methods:
– Between patients, type B applied parts disinfect by wiping them with ethanol (70 vol% to 80 vol%). Disposable paper sheets can be used for this purpose, also.
– Occasionally, control panel, remote controller, headrest, chinrest, seat and headband should be wiped with ethanol (70 vol% to 80 vol%) and LCD surface should be wiped with dry cloth.

Mode of operation Laser Class

Non continuous operation Stand-by is continuous
Class 1 : Positioning Beams, Optical Interface

Product Description
Model: MCT-1 Type: EX (herein after MCT) is a limited cone-beam X-ray CT. MCT makes diagnosis possible with high resolution three-dimensional images for small lesions within a limited area of the extremely complex morphology of the hard tissue of the head and neck region.
High resolution images in the same short period as Panoramic Radiography. Low X-radiation dosage and Compact.

Intended use
MCT-1 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.
Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

Generator/X-Ray Head Assembly

Tube Focal Spot Target Angle Target Material Scan Modes
Operating Tube Potential Operating Tube Current
Reproducibility of Air Kerma Maximum Output Power FOV
Filtration
Beam Quality (HVL) Primary Protective Shield Outer Shell Temperature Duty Cycle
Filament Rectification Cooling Maximum Heat Unit of X-Ray Head Assembly Leakage Radiation
Minimum mAs

D-051 0.5
5º Tungsten
Standard (Std) mode High Fidelity (Hi-Fi) mode (optional) High Resolution (Hi-Res) mode (optional) High Speed (Hi-Speed) mode (optional)
60 kV to 90 kV(accuracy of displayed values ±10%) 1 mA to 10 mA (accuracy of displayed values ±10%) limited up to 8 mA in Hi-Fi and Hi-Res modes Coefficient of variation max. 0.05 0.9 kW nominal at 90 kV, 10 mA 40 × 40 to 170 × 120 mm (Diameter × Height) limited up to 60 × 60 mm in Hi-Res and Hi-Speed modes Inherent filtration minimum 3.1 mm Al, 75 kV/HVL 4.2 mm AL
(X-ray tube: min. 0.8 mm Al, Al plate: min. 1.3 mm, Al wedge filter: min. 1.0 mm)
Min. 3.2 mmAl at 90 kV Minimum 0.5 mm Pb or equivalent
+45ºC (+113ºF) maximum 1:59, 90 kV/10 mA for example, maximum 30.8 s of irradiation with 1818 s (30.3 min) of interval Preheated
Direct Current Oil and Forced Air Cooling 194.45 kJ (1 HU=1.35 Joule)
Max. 1.0 mGy/h at 1 m Max. 0.88 mGy/h at 1 m (valid for USA only) 5.4 mAs

Power Requirements (EX-1)

Input Voltage Fuse (at the distribution panel)

120 V AC 50/60 Hz single phase, Permanent installation Voltage fluctuation shall be within ±5%
20 A, 250 V, slow

Power Consumption Rated Input amperes

Max. 2.0 kVA
Max. 19 A (with operation) Max. 3 A (stand by)

Power Line Resistance

Max. 0.5 ohm

Power Requirements (EX-2)

Input Voltage
Fuse (at the distribution panel) Power Consumption

220/230/240 V AC 50 Hz 60 Hz single phase, Permanent installation Voltage fluctuation shall be within ±5%
16 A, 250 V, slow
2.0 kVA 0.24 kVA (stand by)

Power Line Resistance

Max. 1.0 ohm

Circuit breaker, complied with IEC61058-1 standard, shall be applied. It is recommended to wire a breaker only for this unit.

Mechanical Parameters
SID
SOD (source-object) SSD Outer Dimensions
Main Unit Control Box Vertical Height of Focal Spot Weight of C-arm Patient Positioning
Positioning Beam (laser)

740 (±20) mm for FOV 170 diameter 840 (±20) mm for FOV other diameters 540 (±20) mm 200 (±20) mm minimum
W 1,620 mm × D 1,200 mm × H 2,080 mm W 70 (96) mm × D 40 mm × H 115 mm 1,480 (±20) mm Approx. 70 kg Positioned using 3 positioning beams and an electrically operated positioning system (Scout) Class 1 IEC 60825-1: 2014 Max. 0.39 mW, 655 or 670 nm

Exposure Time

Standard mode High Fidelity mode (optional) High Resolution mode (optional) High Speed mode (optional) Scout mode Accuracy of displayed values Emission Switch

17.5 s (Full:360º) 30.8 s (Full:360º) 30.8 s (Full:360º) 10.5 s (Full:360º) 1.0 s (0.5 s × 2) ± (5% + 50 ms) Dead Man Type

/ 9.0 s (Half:180º) / 15.8 s (Half:180º) / 15.8 s (Half:180º) / 5.4 s (Half:180º)

CT Image Quality
Resolution (MTF)
Other index

More than 0.75 lp/mm @ 50% More than 2.0 lp/mm @ 10%
User Information document

X-ray Dose Information
The following image information is recorded for each exposure. · Dose Area Product (DAP) (mGy × cm2) · tube voltage average (kV) · tube current average (mA)

Refer to the application’s software manual as the displayed image information differs according to the application software.
The Dose Area Product (DAP) (mGy × cm2) may not be displayed depending on the application software.
The displayed Dose Area Product refers to the tube voltage (kV)/current (mA) for each exposure. The Dose Area Product is calculated based on typical measurement results. The Dose Area Product displayed is the multiplication product of the air kerma and the size of the radiation field. These values are typical values and are not the measured Dose Area Products for each X-ray exposure. The air kerma is calculated by divided the Dose Area Product by the X-ray field size. The accuracy of the air kerma and the Dose Area Product do not exceed ±50%. The dose meter to check and maintain the accuracy of the Dose Area Product indications shall be calibrated at the appropriate energy.
Method used to estimate dose area product: Measured by DAP (Dosage Area Product) meter. The DAP meter is calibrated according to the instructions in the accompanying user manual. The DAP meter is attached to the front of the X-ray head. Be careful it does not fall and that its wiring is properly routed.

Leakage Technique Factors
90 kV, 600 mAs/h (90 kV, 10 mA, duty cycle 1:59, for example 17.5 s exposure per 17.2 min cool-down period)

Measurement Bases
The tube voltage kV is measured by differentially monitoring the current flowing through 450 M, 1% feedback resistors connected between the tube anode and ground. The tube current mA is measured by monitoring the current in the HT return line, which equals the tube current.
The exposure time. Starting point of exposure is determined at the time when the kV value reaches to 75% of the average kV. Termination of exposure is determined at the time when the kV value decreases to 75% of the average kV.
Test instruction of X-ray tube voltage, current and exposure time: Constant (manual) exposure mode.

Emergency Stop Conditions

When the Emergency Stop is activated, the automated movements of the equipment will stop within the following distances:

Chair horizontal movements: Within 5 mm

Chair vertical movements:

Within 5 mm

Arm rotation:

Within 10 mm (at the side of the head assembly cover)

Environmental Data

Operating Conditions
Ambient temperature range Humidity Atmospheric pressure range
Transport and Storage Conditions
Ambient temperature range Humidity Atmospheric pressure range
Original Language

+10°C to +30°C (+50°F to +86°F) 30% to 75% no condensation 70 kPa to 106 kPa
-5°C to +43°C (+23°F to +109.4°F) 8% to 85% 70 kPa to 106 kPa English

Disposal
The package should be recycled. Metal parts of the equipment are disposed as scrap metal. Synthetic materials, electrical components, and printed circuit boards are disposed as electrical scrap. Material must be disposed according to the relevant national legal regulations. Consult specialized disposal companies for details. Please consult local city/community administrations concerning local disposal companies.
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Contact your local dealer or J. MORITA OFFICE for details.

Collimator
MCT-1F17 Collimator – motorized variable collimator.

Requirements for Computers or Other Devices Connected to the Computers
1. MCT-1 has been tested and found to comply with the limits for medical devices to the IEC 606011-2 for electro magnetic compatibility. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
– Reorient or relocate the receiving device. – Increase the separation between the equipment. – Connect the equipment into an outlet on a circuit different from that to which the other device(s) are
connected. – Consult the nearest J. MORITA OFFICE, its representative or its dealer for help.
2. The following equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e. IEC 60950-1 or IEC62368-1 for data processing equipment and IEC 60601-1 for medical equipment). Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 60601-1. If in doubt, consult the nearest J. MORITA OFFICE, its representative or its dealer for help.
Some of the following devices may cause some technical problems with 3D Accuitomo. Ask your nearest J. MORITA OFFICE for proper selection of equipment and connections.
69

Hardware

Windows based Personal Computer

CPU:

Intel Xeon dual CPU, or higher, or compatible

Memory:

RAM minimum 16 GB

HDD:

HDD 100 GB or more are recommended

Image Acquisition Intel Pro 1000BASE-TX or SX NIC

Network:

100BASE-TX x2 or adding equivalent NIC

Connection MCT-1 main component

1 ch

1 ch serial communication (RS-232C)

CD/DVD Drive: Recommended

OS:

Microsoft Windows 10 64 bit or latar

Monitor:

17 inch TFT LCD

16 million colors

1024 × 768 pixels or better

Standard:

IEC60950-1, IEC62368-1, or IEC60601-1

EMC regulation

Related UL standard (U.S.)

Related C-UL standard (Canada)

Local regulations

Hub

10 Base-T, Non intelligent Shared HUB

Standard:

IEC60950-1 or IEC62368-1 if it is used in non patient environment

IEC60601-1 or

IEC60950-1 or IEC62368-1 with leakage current conformed with IEC60601-1

EMC regulation

Related UL standard (U.S.)

Related C-UL standard (Canada)

Local regulations

Storage Device

DVD-RW burner is recommended as the data storage device.

Standard:

IEC60950-1 or IEC62368-1 if it is used in non patient environment

EMC regulations

Related UL standard (U.S.)

Related C-UL standard (Canada)

Local regulations

Media Converter

1000BASE-TX/SX Gigabit Media Converter Hobbes, HME2-1000 or equivalent

Other equipment connected to PC directly

Standard:

IEC60950-1 or IEC62368-1 if it is used in non patient environment

EMC regulation

Related UL standard (U.S.)

Related C-UL standard (Canada)

Local regulations

Cables

RS-232C: Optical Fiber:

Shielded crossover, 9-pin D-Sub, Female to male Non-conductive connector housings required
Length less than 15 m 2P, Multi-mode, Push-lock SC Connectors Length less than 15 m

· Above devices may not be located in the x ray protection area or the patient vicinity.
* The patient vicinity is the area where intentional or unintentional contact can occur between a patient or a patient’s attendant and the above devices, or between a patient or a patient’s attendant and other persons touching the above devices. This area extends 1.83 m beyond the perimeter of the bed (examination table, dental chair, treatment booth, and the like) in its intended location, and vertically 2.29 m above the floor.
· Connect only items that have been specified as part of medical electric system or specified
as being compatible with medical electric system.
· Do not use multiple portable socket outlet nor extension cord for the system power supply.
* Computers or any other external devices must be connected in accordance with IEC 60601-1. * Computers or any other external devices must be cleaned in accordance with the manufac-
turer’s instructions. * Computers or any other external devices must be transport, storage, and operation in ac-
cordance with the manufacturer’s instructions.
Application Software
Application software i-Dixel ver. 2.3 or later provided by J. MORITA is used to process and view the images. It shall be used with an Windows based computer matching to the above mentioned specifications.
71

Symbols and Markings (EX-1)
* Some symbols may not be used.
Laser Caution Label
X-ray Tube Head Assembly Label
Rating Label Main Switch | : On
: Off

Focal Spot

Caution Label Emergency Stop Type B Applied Part

X-ray Warning Label

Equipotentiality
Use this terminal when it is required to use potential equipotentialization conductors, do not use for protective earth connection.
Chinrest Warning Label
Key Switch : On : Off

Accuracy Label
Audible Signal Label X-ray Warning (Canada) X-ray Emission Switch

Symbols and Markings (EX-2)
* Some symbols may not be used.
Laser Caution Label

Focal Spot

X-ray Tube Head Assembly Label
Rating Label
Main Switch | : On
: Off

Caution Label Emergency Stop
Type B Applied Part
Warning Label Notice Label

Key Switch
: On : Off

Equipotentiality
Use this terminal when it is required to use potential equipotentialization conductors, do not use for protective earth connection.

Warning Label

X-ray Emission Switch

Package

This way up

Keep away from rain

Humidity limitation Attention, consult accompany documents

Prescription Device CAUTION: Federal law restricts this device to sale by or on the order of a dentist and a
licensed healthcare practitioner. (Valid only for U.S.A.)

* Some symbols may not be used.
Fragile
Temperature limitation
Atmospheric pressure limitation
Do not reuse
Country or region (Country Names: Conforming to the ISO 3166-1 alpha-3 codes and EU for European Union) Description noted next to the code is an indication that conforms to the regulations valid only for the relevant country or region.

Packaging unit

Importer

Distributor

Registration number of medical device in Thailand
(The 12-digit sample number shown is for demonstration purposes only.)

Rating Label, X-ray Tube Head Assembly Label, and Operation Instructions

Serial Number

Unique device identifier

Medical device

Manufacturer

Date of manufacture

GS1 DataMatrix

Alternating current
Country or region (Country Names: Conforming to the ISO 3166-1 alpha-3 codes and EU for European Union) Description noted next to the code is an indication that conforms to the regulations valid only for the relevant country or region.
Marking of electrical equipment in accordance with the European Directive 2012/19/EU (WEEE) (Valid only for EU)
CE(0197) marking (Valid only for EU)
Conforms with the European Directive, 93/42/EEC.
CE marking (Valid only for EU)
Conforms with the European Directive, 2011/65/EU.
74

Refer to instructions for use
EU authorized representative under the European Directive 93/42/EEC (Valid only for EU)
cTUVus certification mark (Valid only for U.S.A. and Canada)
Authorized representative in Switzerland

Indicated Items on the Rating Label and X-ray Tube Head Assembly Label
* For details, refer to “Technical Specifications” (p.65). * Some symbols described on the previous page may be included. Rating Label
Model: Model of X-ray system Type: Type Input: Rated input voltage, frequency, and power in operation Standby: Input power in standby Duty Cycle: Duty cycle of X-ray system 2D barcode at bottom right: Label code X-ray Tube Head Assembly Label MODEL: Model of tube housing assembly HEAD NO.: Serial number of tube housing assembly DATE OF MFG.: Date of manufacture TOTAL FILTRATION: Min. inherent filtration RATING: Rated output of tube housing assembly TUBE MODEL: Model of X-ray tube TUBE ANODE NO.: Serial number of X-ray tube MFD. BY: Manufacturer of X-ray tube EFFECTIVE FOCAL SPOT: Nominal focal spot value
75

Tube Housing Assembly Information Heating Curve
(kJ)

Cooling Curve (kJ)

(min)

(min) 76

Tube Rating Chart

Maximum Rating Chart (Absolute Maximum Rating Charts)
D051
DC Focal Spot: 0.5mm

80kV

70kV

90kV 100kV

60kV

50kV

TUBE CURRENT (mA)

EXPOSURE TIME (S)

Anode Thermal Characteristics

D051

280W

230W

170W

HEAT STORAGE (kJ)

COOLING HEATING
TIME (min) 77

Relationship of Focal Spot, X-ray Beam and Image Detector 78

9. Electromagnetic Disturbances (EMD)
The 3D Accuitomo XYZ Slice View Tomograph (Model: MCT-1, hereafter “this device”) conforms to IEC 60601-1-2 Edition 4.1, the relevant international standard for electromagnetic disturbances (EMD).
Use Environment The use environment of this device is the Professional healthcare facility environment.

· Use of this device adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this device and the other equipment should be observed to verify that they are operating normally.
· Use of accessories, transducers and cables other than those specified or provided by us
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
· Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MCT-1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this device could result.
· RFID readers and electronic article surveillance (EAS) systems should not be near from
any part of the MCT-1.

Cable List

No.

Name

1 Serial Cable

Cable Length, Shielding 15 m, Shielded

SIP/SOP & In/Out Port Type SIP/SOP

Compliance for Each EMISSIONS and IMMUNITY Standards

Emissions Test
Conducted disturbance CISPR 11

Compliance
Group 1 Class B

Electromagnetic Environment Guidance
This device 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.

Radiated disturbance CISPR 11
Harmonic current IEC 61000-3-2
Voltage fluctuations and flicker IEC 61000-3-3

Group 1 Class B Class A
Clause 5

This device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

±2 kV, ±4 kV, ±6 kV, ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transients/bursts IEC 61000-4-4

±2 kV for power supply lines
±1 kV for input/output lines

±2 kV for power supply lines
±1 kV for input/output line

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

AC/DC power ±0.5 kV, ±1 kV line(s) to line(s) ±0.5 kV, ±1 kV, ±2 kV line(s) to earth
Signal input/output ±2 kV line(s) to earth

AC/DC power ±0.5 kV, ±1 kV line(s) to line(s) ±0.5 kV, ±1 kV, ±2 kV line(s) to earth
Signal input/output*1 ±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

dips
0% UT: 0.5 cycle (at 0, 45, 90, 135, 180, 225, 270, 315°) 0% UT: 1 cycle (at 0°) 70% UT: 25/30 cycles (at 0°)
25 (50 Hz)/30 (60 Hz)
short interruptions
0% UT: 250/300 cycles 250 (50 Hz)/300 (60 Hz)

Mains power quality should be that of a typical commercial or hospital environment. If user of this device requires continued operation during power mains interruptions, it is recommended that this device be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m (r.m.s.) 50 Hz or 60 Hz

Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Proximity magnetic fields IEC61000-4-39

30 kHz CW, 8 A/m
134.2 kHz 2.1 kHz, 65 A/m
13.56 MHz 50 kHz, 7.5 A/m

30 kHz CW, 8 A/m*2
134.2 kHz 2.1 kHz, 65 A/m*3
13.56 MHz 50 kHz, 7.5 A/m*3

The proximity magnetic
field should be at a level
characteristic of magnetic fields emitted from RFID, IH (Induction Heating), etc.

NOTE 1: UT is the a.c. mains voltage prior to application of the test level. NOTE 2: r.m.s.: root mean square
*1: Not applicable because it does not connect directly to outdoor cable. *2: This test is not applicalble since this device is not intended for use in the HOME HEALTHCARE
ENVIRONMENT. *3: This test is not applicable since this device does not use a circuit that is sensitive to magnetic fields,
such as a Hall element or a magnetic resistance element.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3

3 V ISM(c) / amateur radio frequency band: 6 V 150 kHz to 80 MHz
3 V/m 80 MHz to 2.7 GHz
27 V/m 385 MHz
28 V/m 450 MHz
9 V/m 710, 745, 780 MHz
28 V/m 810, 870, 930, MHz
28 V/m 1720, 1845, 1970 MHz
28 V/m 2450 MHz
9 V/m 5240, 5500, 5785 MHz

Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distances

d = 1.2 P

d = 2.3 P

d =

6 E

150 kHz to 80 MHz 80 MHz to 800 MHz
800 MHz to 2.7 GHz
Portable wireless RF communication equipment

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, E is the compliance level in V/m and d is the recommended separation distance in meters (m).

Field strengths from field RF transmitters, as determined by an electromagnetic site survey(a), should
be less than the compliance level in each frequency range(b).

Interference may occur in the vicinity of equipment marked with the follow-
ing symbol:

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 reflection from structures, objects and people.
(a) Field strengths from fixed transmitters, such as base stations for ratio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this device is used exceeds the applicable RF compliance level above, this device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting of relocating this device.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
(c) The ISM (Industrial, Scientific and Medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

Pass / Fail Criteria on Immunity Test · No X-ray irradiation without active operation of the emission button. · X-ray termination with release of the emission button. · No unexpected movement of the equipment.
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Documents / Resources

MORTIA XYZ Slice View Tomo Graph [pdf] Instruction Manual
F17, X055-91001-506, XYZ Slice View Tomo Graph, XYZ, Slice View Tomo Graph, View Tomo Graph, Tomo Graph, Graph

References

User Manual

MORTIA XYZ Slice View Tomo Graph

Specifications

Product Usage Instructions

FAQs

Prevent Accidents

For Safe Operation

Parts Identification

Operation

Maintenance, Parts Replacement, and Storage

Regular Inspection

Troubleshooting

Documents / Resources

References

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