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Product Description
Model and specifications
Structure
The dental X-ray unit consists of key components including an X-ray tube head, control box, and a frame featuring both a cross arm and telescopic arm It is categorized into two types based on its installation: the wall-mounted dental X-ray unit (SIRAY) and the floor-mounted dental X-ray unit (SIRAY PLUS) Below is a panoramic view of the device.
Wall-mounted dental X-ray unit (SIRAY)
Maximum load：the Control box is 20.4kg，the Cross arm is 16kg，the Telescopic arm A is 8.8kg，the Telescopic arm B is 5.5kg
Floor-mounted dental X-ray unit (SIRAY PLUS)
1 Tube head 5 Control box (inside the base joint cover)
Maximum load：the seat is 135kg，the column is 13.5kg，the Cross arm is 11kg，the Telescopic arm is 5.5 kg.
Intended use
This equipment is used clinically to shoot teeth and tissues film It is limited to dental clinic or dental hospital clinical for diagnosis, is limited to the dentist
Dental x-ray unit is prohibited in pregnant women and children.
Technical parameters
1.4.1 The technical parameters of this medical device are listed in the following table:
Safety class I Tube voltage 55kV/60kV/65kV/70kV
Type Type B Tube current 4mA/7mA
Intermittent-loading continuous-operations Load cycle 1/60
Applied parts for SIRAY PLUS are seat, and no applied parts for SIRAY
The PFC and three-phase bridge rectifier circuit are integral to the design, ensuring a consistent duty cycle This design prevents the unit from functioning as a single or dual peak high-voltage generator, while also ensuring that the radiation time remains unaffected by grid pulses The technical parameters of the X-ray tube are crucial for its performance and efficiency.
Manufacturer Name: Canon Electron Tubes & Devices Co., Ltd
Serial No.: Refer to the nameplate
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth
During prolonged use, an overheating signal is triggered when the tube's temperature exceeds 60°C The temperature sensor communicates this to the MCU, which then halts the voltage and current supply to the tube, displaying the error code “H3” on the operation panel The MCU also regulates the cooling duration required before re-exposure can occur In case of a malfunction in the main MCU, the backup MCU will immediately disconnect the voltage and current to the tube to ensure safety.
Therefore, it ensures that the oil that cools the X-ray tube does not expand due to the heat, resulting in failure of the seal and oil leakage
High Voltage Generator Constant Potential High-voltage Generator Grounding Center-grounded Nominal X-ray Tube Voltage 70 kV Nominal Focal Spot Value 0.7 Nominal Anode Input Power (at 1.0s) 940 W
Protection level IP20 Total filtration ≥ 1.5mmAl(70kV)
Power supply voltage AC230V Inherent filtration ≥ 1mmAl(70kV)
Main fuse tube T10AL250V/Φ5X20 Half-value layer About 1.5mm Al at 70kV
Input power 900VA Radiation leakage rate Less than 0.25mGy/h at a distance of 1m Power frequency 50/60Hz Loading time adjustment range 0.02～3.2s
Ray focus 0.7mm Distance between the focus of the circular output load surface mouth of the snoot and the skin 22cm
Anode angle 16゜ The output radiation field of the circular output load surface mouth of the snoot Φ6cm Mass of
SIRAY 25kg Mass of SIRAY PLUS 84kg
Apparent resistance 0.2Ω Accuracy of LOADING FACTORS
Nominal Radiographic Anode Input Power 980 W Exposure Duty Cycle 1:60 or More
(Exposure Time : Interval Time) Mechanical:
Overall Length See Dimensional Outline Maximum Diameter See Dimensional Outline Target:
The anode angle is set at 16 degrees, constructed from tungsten material, ensuring high durability It features inherent filtration of at least 1.0 mm of aluminum at 70 kV, providing effective X-ray coverage with a diameter of 107 mm at a source-to-image distance of 200 mm The approximate weight of the assembly is 100 grams, and it employs an oil immersion cooling method, with a maximum temperature of 60℃, supplemented by convection oil cooling for optimal performance.
Tube Holding… Holding the glass envelope of the anode end and cathode end, or the screw of the anode shank
Absolute Maximum and Minimum Ratings
(At any time, these values must not be exceeded.)
Maximum X-ray Tube Voltage 70 kV Between Anode (or Cathode) and Ground 35 kV Minimum X-ray Tube Voltage 50 kV Maximum X-ray Tube Current 19.9 mA (See Rating Charts)
Maximum Filament Current 3.0 A Filament Voltage:
At Maximum Filament Current (3.0 A) 3.0 ~ 3.7 V Filament Frequency Limits DC or AC (Sine Wave) 0 ~ 20 kHz Thermal Characteristics:
Anode Heat Content 7 kJ (10 kHU) Maximum Anode Heat Dissipation 210 W (300 HU/s)
Operating Limits (In Dielectric Oil):
Oil Temperature 10~ 60℃Oil Pressure 70~ 140 kPa
(No Condensation) Atmospheric Pressure 50 ~ 106 kPa
Contra-indications
X-ray radiation is prohibited in pregnant women and children.
Precautions, warnings and tips
When using this device, be sure to follow the basic safety precautions listed below to reduce the risk of device damage, fire, electric shock, personal injury and other hazards:
*Follow all warnings and instructions given on the device and in the accompanying text document If any
When encountering a conflict between operating instructions and safety information, prioritize the safety guidelines, as there may be a misunderstanding of the operating instructions If the discrepancy remains unresolved, seek assistance from a qualified professional.
* Please turn off the device's main power before maintenance and cleaning
* Do not place the device on unstable floors, carts or racks as the device may fall and cause damage
* Do not place the device near radiators or heaters
* Do not use the device in the presence of any flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide
* Do not place or hang heavy objects on the device
Using non-compliant wires with your device can lead to compromised performance, and may even pose serious risks such as fire hazards or electric shocks Always ensure that the wires you use meet the necessary requirements for safe operation.
To ensure safety, avoid inserting objects into the device's housing or openings, as this may expose you to dangerous voltage and risk fire or electric shock Additionally, keep liquids away from the device to prevent damage.
* Do not use with the patient while parts of the equipment are serviced or maintained
* Do not position the equipment too difficult to operate the disconnection from the supply mains
* To avoid the risk of electric shock, do not disassemble the device without prior authorization If you need to repair the device, please contact professional technical service personnel
* Opening or removing the cover may expose you to dangerous voltages or other dangers Improper assembly may cause electric shocks during subsequent use of the device
* In the event of the following cases, turn off the main power switch and ask professional service personnel for help:
(1) Any part of the power cord, plug, or connecting cable is damaged or frayed
(2) Unknown liquid is spilled into the device or the circuit of the device
(3) The performance of the device suddenly changes significantly The device still cannot work normally after being operated according to the instructions
* Please adjust only the controls mentioned in the operation instructions Incorrect adjustment of other controls may result in device damage
* Avoid using the device during thunderstorms Thunderstorms may cause a lightning strike If possible, turn off the main power during a thunderstorm
* Do not use a damaged or loose plug Insecure plug connections may cause electric shocks or sparks, which will lead to fires
* Grounded plugs and sockets must be used Poor grounding may result in electric shocks or equipment damage
Warning: When a patient has a cardiac pacemaker or hearing aid, the possible influence of the dental x-ray unit on it shall be taken into account
Warning: This device may only be used by authorized and trained individuals The manufacturer is not liable for any incorrect operation, negligence or inapplicability
Warning: When the exposure is finished and you leave work, the main power must be turned off
Warning: Users need to provide means for audio and visual communication between the operator and the patient
The notes provide comprehensive details on all optional components for both the fixed SIRAY PLUS and wall-mounted SIRAY models; however, please note that certain information may not be relevant to your specific machine.
This manual outlines the operations and maintenance procedures for the dental X-ray unit, with all information being accurate as of the publication date Please note that the company retains the right to change device specifications or designs at any time without prior notification to users.
This manual is protected and may not be modified, distributed, republished, or sold in any format without our company's prior written consent We retain the authority to interpret and amend all information contained within this document.
Caution: The guaranteed content shall be invalid in the event of non-compliance with any of the following alerts:
(1) Observe the terms described in the instructions
(2) The device must only be used according to the contents of this manual
(3) The indoor power cord installed shall be a three-core power cord of 1 square millimeter or more
(4) The device shall be installed according to the requirements
(5) Any maintenance, modification or correction operations related to access to the inside of the device must be performed by an engineer of our company
(6) Any accessories and used devices must be replaced by our company Otherwise the performance and safety of the dental X-ray unit will be affected.
Device Operation Instructions
Description of the operating panel and operation keys
2.1.1 Illustration of the operating panel
2.1.2 Description of buttons and symbols
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
Multi-tooth When this button is pressed, the corresponding exposure indicator and the ready-for-exposure indicator will be lit constantly, and then the exposure can be proceed
Press and hold the Exposure button to initiate the exposure process, which will cause the exposure indicator to glow steadily in yellow Once the exposure is finished, the indicator will turn off.
Press and hold the Exposure button to initiate the exposure process, during which the exposure indicator will remain lit in yellow Once the exposure is complete, the indicator will turn off.
Ready-for- exposure indicator The ready-for-exposure indicator used jointly with the operating procedure
Patient Figure Press the patient size button to toggle between the two choices, Large size and Small size, with the corresponding indicator lit constantly
“Film”, “PSP” or “Digital Program” can be selected Non-lit indicator indicates that “Film” is selected Lit indicator indicates that “PSP” or “Digital Program” is selected
When selecting voltage levels of 55kV, 60kV, 65kV, or 70kV, specific indicator light patterns are observed: at 55kV, two indicator lights remain illuminated; at 60kV, the upper indicator light stays on; at 65kV, both indicator lights turn off; and at 70kV, the lower indicator light is consistently on.
Current 7mA or 4mA, with the corresponding indicator lit constantly
Exposure Time Adjusts the exposure time
Display the voltage, current, exposure time, cumulative exposure times and error codes；
When the exposure time is displayed, the time more than 0.2s (including 0.2s) takes s as unit, and the time less than 0.2s takes ms as unit
Radiation Warning Sign Caution Sign
Setting and display of parameters
Once the installation has been thoroughly checked for any issues, connect the power supply and switch it on The power indicator will illuminate, and upon completing the self-test, the operating panel will show the parameters from the last operations performed.
To enter the program mode setting on your device, press and hold the Mode button for 5 seconds until you hear three buzzes Once this occurs, the Ready-for-Exposure indicator will turn off, signaling that the device is now in program mode.
The program is selected with the Exposure Time button and shown on the display Program definitions are:
Film Exposure Speed , Sensor , Film Type Selection , Buzzer Volume , Cumulative Exposures , and Restore Factory Settings , cycled in sequence
Once the settings are finalized, press and hold the Mode button for 5 seconds until you hear three buzzes, or simply wait for 10 seconds of inactivity This action will exit the program setting mode, and the Ready-for-Exposure indicator will illuminate steadily.
In the program mode setting, selecting "Film Exposure Speed" allows you to press the Mode button to access the Film Exposure Speed Selection mode From there, you can use the Exposure Time button to choose from three available speeds.
In program mode, selecting "Sensor" allows you to access Sensor Selection mode by pressing the Mode button You can then use the Exposure Time button to choose the Ordinary sensor.
In the program mode, selecting "Buzzer Volume" allows you to enter the Buzzer Volume Selection mode by pressing the Mode button From there, you can use the Exposure Time button to choose from nine different volume levels.
In program mode, selecting "Exposure Speed" allows you to access the Cumulative Exposure Times Display by pressing the Mode button, where you can adjust the settings using the Exposure Time button.
11 the displayed values of the ones, tens, hundreds, thousands, ten-thousands and hundred-thousands digits respectively
In program mode, selecting "Exposure Speed" allows you to access the Restore Factory Settings feature by pressing the Mode button Use the Exposure Time button to choose and confirm the restoration of factory settings, which will not erase the cumulative exposure times.
Operations of the manual button panel and function button memory settings
2.3.2 Setting of tooth position buttons (8 buttons in total)
To set the tooth position button, adjust the parameters such as tooth position, mode, patient figure, voltage, current, and exposure time to the desired levels Then, press and hold the relevant tooth position selection button for approximately the specified duration.
5 seconds until you hear a prompting sound, then the current parameters will be stored for the corresponding tooth position button
Operations of a tooth position button: Select the corresponding tooth position selection button according to the shooting requirements and then the corresponding indicator will be lit constantly
2.3.3 Operations of the Mode button
To select a mode, press the Mode button and choose between "Film," "PSP," or "Digital Program," ensuring the corresponding indicator lights up continuously; note that the indicator will remain off in Film mode.
2.3.4 Operations of the Patient Size Selection button
Press the patient size button to toggle between the two choices, Large size and Small size With the corresponding indicator lit constantly
2.3.5 Operations of the Voltage button
To select the desired voltage, press the Voltage button to choose between "55kV," "60kV," "65kV," or "70kV." The indicator lights provide feedback based on your selection: for 55kV, two indicator lights remain on; for 60kV, the upper indicator light stays on; for 65kV, both indicator lights turn off; and for 70kV, the lower indicator light remains illuminated.
2.3.6 Operations of the Current button
Press the Current button to choose “7mA” or “4mA,” and then the corresponding indicator will be lit constantly
2.3.7 Operations of the Exposure Time Button
Press the Exposure Time button to choose the exposure time and then the display will show the corresponding exposure time Press or to increase or reduce the exposure time
2.3.8 Operations of the Exposure Button
To initiate the exposure process, press and hold the Exposure button after selecting the desired parameters for each item The exposure indicator will light up in yellow and a “beep” sound will be emitted by the buzzer You can release the Exposure button only once the exposure indicator turns off and the buzzer ceases to sound.
In the event of an emergency, the exposure can stop when the Exposure button is released.
Place the dental film
After adjusting the exposure time and voltage, position the dental film in the patient's mouth, instructing them to hold it in place with their index finger Align the cone of the tube head so that its end is approximately 10 mm from the skin, ensuring that the X-ray beam is perpendicular to the bisector of the angle formed between the tooth's long axis and the film.
See the following table for details of the average X-ray tilt angles for projecting the maxillary and mandibular teeth according to the desired angles of the teeth:
Tooth Position Number X-ray Tilt Direction X-ray Tube Tilt Angle
Bicuspid tooth and the first molar 4, 5, 6 Downward +30°
The second and third molars 7, 8 Downward +28°
Bicuspid tooth and the first molar 4, 5, 6 Upward -10°
The second and third molars 7, 8 Upward -5°
The numbers and layout of all teeth:
Safety protection function
Once the dental X-ray exposure is complete, the unit enters a natural cooling protection mode, displaying a countdown timer During this cooling period, pressing the exposure button on the controller will not activate the unit Once the cooling process is finished and the device returns to its last operational state, it is ready to perform new tasks.
During an exposure, in the event of an emergency, the exposure can stop when the Exposure button is released
Precautions
To optimize the use of photosensitizers, it is crucial to maximize the distance between the focus and the skin when the photosensitizer dose is adequate This approach minimizes X-ray exposure to the patient while also reducing image distortion.
During the loading process, operators must maintain a distance of at least 3 meters from the tube head and avoid standing in the direction of X-ray radiation It is essential for operators to utilize protective devices and wear appropriate protective clothing If local health regulations mandate the establishment of an engine room and necessary protective facilities, compliance with these provisions is required The designated important area occupied by the operator is illustrated in the accompanying figure.
In case of an unexpected emergency, such as activating the power switch or pressing the Exposure button, it is crucial to turn off the power switch immediately if the exposure indicator remains lit or the buzzer continues to sound This action is essential to prevent radiation exposure or potential damage to the machine.
The radiation dose test method for operating equipment involves measuring the average air Kerma rate at a distance of 1 meter from the X-ray tube's focus point, while the device runs at its nominal voltage with a maximum input energy equivalent to 1 hour It is crucial that the air Kerma rate does not exceed 1.0 mGy/h within any 100 cm² area, with the main linear dimension not exceeding 20 cm Additionally, adjusting the exposure time of the equipment can significantly influence the radiation exposure experienced by the operator.
(1) In areas with unstable power supplies, a voltage regulator shall be provided, and the capacity of the voltage regulator shall be no less than 2kVA
(2) For details of the applicable conditions of various types of dental film, see the applicable conditions of various types of dental film in the following table
Use conditions for various types of dental film:
The Set Parameters of the Dental X-ray Unit Development Method and Development
Time kV Mode Light Room Darkroom
1 Film 60 or 70 3 minutes or more 3 minutes or more
The radiation produced by the device is x-rays, which are essentially electromagnetic radiation
The entrance surface dose (ESD) is used to quantify patient radiation exposure, measured directly from a distance of 22 cm from the radiation source within a 6 cm area, without a reference object The results of the ESD measurements are detailed in the accompanying table.
Time of exposure(s) 70kV 60kV
Exposure values
The first time you turn on the dental x-ray unit, the default exposure values are displayed
These values can also be customized according to actual use The recommended exposure values are shown in the table below:
Exposure Time Table mA/ kV
Installation, Commissioning and Maintenance of the Dental X-ray Unit
Installation conditions
Caution: The installation of this device must be completed by the company's professional personnel or personnel trained and authorized by the company
This device shall be placed in a clean, dry, ventilated and shaded place Retain enough space around the device for routine maintenance
Do not install and use the device in the following places:
(1) Humid, dusty or poorly ventilated places or places in direct sunlight;
(2) places where changes in high temperatures or high humidity often occur, e.g., places near air conditioners and heaters;
Caution: Improper installation may damage the device!
Determine the installation location according to the overall layout of the clinic room, lighting, use convenience
To ensure optimal performance, the machine should be installed in a clean, dry, well-ventilated, and cool environment It is crucial that the mounting base's contact surface is flat, horizontal, and stable Additionally, the wall supporting the equipment must withstand a minimum load of 25 Kg, while the floor must support at least 85 Kg.
The device shall be transported to the desired installation site according to the method specified on the outer packaging box
Device packaging can be removed
Take out the packing list and check the configuration and accessories to see if they are intact If you have any doubts, please contact the company in time.
Device installation method
3.2.1 Installation of wall-mounted dental X-ray unit (SIRAY)
Dimensions of the X-ray room: 2 meters（or 2.4 meters） in length, 2 meters（or 2.4 meters） in width and 2.4 meters in height
The following figure shows the dimensions of the unfolded device It is designed to be of safe dimensions that will not cause device bumps
The power supply is 230V with a ground wire and the wire diameter is no less than 1mm 2 Power supply voltage: 230±10% VAC; power supply frequency: 50/60Hz
3.2.1.1 Installation of cross arm and telescopic arm
To assemble the cross arm, thread it through the upper connecting shaft, body, lower connecting shaft, and gasket as indicated by the thick dashed line in the figure Secure the upper and lower connecting shafts to the cross arm body using M5x12 screws Next, attach the telescopic arm to the upper connecting shaft, and complete the assembly by installing the cross arm end cover.
3.2.1.2 Installation of the control box and telescopic arm assembly
First, fix the bottom plate of the control box to the wall with M8 expansion bolts, then observe horizontal bubble and keep it level
Install the telescopic arm assembly on the cross arm fixer and tighten limit screws Then separately install damping block, spring, damping adjusting nut and bumping post decorative cap
To properly install the telescopic arm, wrap the two longest wires around the magnetic ring twice and secure them Next, connect the wire plug from the telescopic arm to the corresponding connector on the circuit board within the control box, ensuring a secure fit Finally, make sure to install the ground wire for optimal performance.
3.2.1.3 Installation of the tube head
Remove the front joint cover of the telescopic arm
To properly assemble the telescopic arm and tube head, first insert the cable from the tube head into the telescopic arm Next, place the flange of the tube head's bending arm into the designated hole on the front connector of the telescopic arm Secure the positioning pieces and tighten the screws After that, connect and secure the cable plug of the tube head to the cable plug of the telescopic arm, and finally, install the front joint cover of the telescopic arm.
3.2.1.4 The Installation of Operating Panel (Installed outdoors)
When installing an outdoor operation panel, it is essential to replace the spring connection line with a straight connection line Begin by opening the covers of both the control box and the operating panel Next, remove the spring connecting line and connect the circuit boards of the control box and operating panel using the straight connection line After securing the connections, reinstall the covers of both the control box and operating panel Finally, adjust the operating panel hanger to the desired position for installation.
3.2.2.1 Commissioning of the cross arm
To ensure proper alignment, verify that the horizontal bubble of the holder attached to the control box's cross arm is level If it is not, loosen the M8x12 limit lead screws and adjust the cross arm holder to achieve the correct position, then securely tighten the lead screws.
3.2.2.2 Commissioning of the telescopic arm
To ensure optimal performance, verify that the strength of the telescopic arm is suitable If the strength is either excessive or insufficient, remove the decorative cover to adjust the damping and elastic force to the desired level, then reattach the decorative cover.
3.2.2.3 Commissioning of the tube head
To ensure optimal performance, verify the bending arm strength of the tube head If the strength is either too high or too low, carefully remove the arm cover to adjust the damping and elastic force of the telescopic arm to the desired level, and then reattach the arm cover.
3.2.3 Installation of floor-mounted dental X-ray unit (SIRAY PLUS)
Dimensions of the X-ray room: 1.6 meters in length, 1.43 meters in width, and 2.2 meters in height
The following figure shows the dimensions of the unfolded device It is designed to be of safe dimensions that will not cause device bumps
Installation of floor-mounted dental X-ray unit dimension drawing 3.2.3.1 Installation method
Secure the base plate components to the floor using Φ10 expansion bolts, ensuring they are level Additionally, verify that the main control board mounted on the base plate is tightly fastened.
To install the column on the base plate, use four M10x20 screws Next, insert the wire from the arm assembly into the column assembly, and secure the arm assembly to the column using M6x40 screws Finally, connect all wires in the column to the corresponding sockets on the main control board.
The PCB shielding cover and base plate cover are respectively mounted on the base plate
Insert the air spring into the air spring hole and insert the seat cushion on the air spring
Connect and fix the plug of the X-ray tube head and the plug of the arm body assembly, fix the locating plate, and install the front connector cover
Install the control box assembly on the column with 2 M4x10 screws and connect the wire and power cord of the control box assembly
3.2.3.2 Debug The Cross Arm Damping
The structure is similar as shown below It’s same as debugging method for the cross arm damping of a wall- mounted dental X-ray machine Please refer to 3.2.2.1
3.2.3.3 Debug The Telescopic Arm Damping
The structure is similar as shown below It’s same as debugging method for the telescopic arm damping of a wall-mounted dental X-ray machine Please refer to 3.2.2.2
3.2.3.4 Commissioning of the tube head
The same as the commissioning method of the tube head of the wall-mounted type See 3.2.2.3 for details
Maintenance of the device
Caution: The correct maintenance method can extend the life of the device!
The X-ray generator (X-ray tube head) shall not vibrate and bump violently while being used
When the fuse is broken, replace it with the fuse of the original model after troubleshooting
The seat and backrest do not require special maintenance It is recommended to wipe them with a towel whenever a patient is treated
The device’s external components (e.g., the mouth of the cone) that often contact with doctors, nurses or patients must be wiped with alcohol once every day
Caution: When cleaning the surface of the dental X-ray unit, disconnect the main power
Caution: Do not use abrasives or acidic products.
The normal operations, transportation and storage conditions for the machine
Normal Operations Transportation and Storage
Atmospheric pressure 70kPa～106kPa Atmospheric pressure 50kPa～106kPa
Common Troubleshooting and Other Matters
Common fault analysis and maintenance
Error messages are divided into two categories One category is Use Error (H) and the other System Error (E) Use errors can be quickly processed
Display Content Error Cause Solution
E1 Abnormal self-test during boot-up Contact the maintenance department
E2 Communication error Contact the maintenance department
E3 The filament signal line is not connected or shorted Contact the maintenance department
E4 The tube voltage signal line is not connected or shorted Contact the maintenance department
E5 The tube current signal line is not connected or shorted Contact the maintenance department
E6 The temperature signal line is not connected or shorted Contact the maintenance department
E7 Low tube voltage Contact the maintenance department
E8 Low tube current Contact the maintenance department
H1 The Exposure button fails to bounce up Check the button
H2 Exposure is interrupted before the time expires Re-exposure
H3 High temperature of the tube head Wait until the tube head is cool
Replacement of the fuse tube
To replace a fuse, first turn off the main power switch Locate the fuse holder on the front of the control box, then use a medium slotted screwdriver to unscrew the fuse cap Insert a new fuse and reverse the previous steps to complete the process.
Fuse Specification Main fuse T10AL250V/Φ5X20
The device’s service life
This device has an expected service life of five years See the nameplate for the production date.
Graphics and symbols used for the device
It appears alone if other contents are shown in the user manual
“Caution”, it means important information for users or service personnel
“Warning”, it means that failure to follow the Manual may cause personal injury or damage to the device and its components
“No wet” sign "Fragile" sign
"Up" sign Storage humidity limit sign
Storage temperature limit sign Storage Atmospheric Pressure limit sign
Stacking limit by 6 Stacking limit by 3.
Means “See the accompanying document”
The symbol signifies "Do not dispose of electronic devices irresponsibly." Regulations mandate that once an electronic device reaches its expiration date, it must be disposed of in accordance with local legal requirements to prevent environmental pollution and ensure user safety.
“Grounding” sign Class: Class B of Type I
IP20 Waterproofness grade sign Radiation warning sign
X-ray source device: transmitter Manufacturer
Date of manufacture CE mark
European Authorized Representative Hazardous voltage
No stepping X-ray filter plate
Electromagnetic Compatibility
The dental X-ray machine meets the relevant electromagnetic compatibility requirements of the standard IEC60601-1-2
The user shall install and use the device according to the information provided in the accompanying document
Portable and mobile RF communication devices can affect the performance of dental X-ray machines To ensure optimal operation, it is essential to avoid strong electromagnetic interference from sources such as mobile phones and microwave ovens when using these devices.
See Annex for details of the guidelines and the manufacturers' statements
To ensure optimal performance and safety, the dental X-ray machine must be positioned away from other equipment and not stacked with them during use It is essential to regularly check and confirm that the machine operates correctly with the appropriate settings.
Using cables not supplied by the dental X-ray unit manufacturer as spare parts for internal components can lead to increased emissions from the dental X-ray machine or decreased immunity.
The dental X-ray unit is designed for operation within a specified electromagnetic environment, and it is the responsibility of the customer or user to ensure that the unit is utilized in compliance with these environmental guidelines.
Emissions test Compliance Electromagnetic environment - guideline
The dental X-ray unit classified under CISPR 11 Group 1 operates using RF energy solely for its internal functions, resulting in minimal RF emissions Consequently, it is unlikely to interfere with nearby electronic devices.
The CISPR 11 Class B dental X-ray unit is designed for use in various settings, including residential areas and facilities linked to the public low-voltage power supply network serving domestic buildings.
Guidelines and the manufacturer's declaration − electromagnetic immunity
The dental X-ray unit image intensifier is designed for operation within a specified electromagnetic environment Users must ensure that the device is utilized in compliance with these environmental conditions to maintain optimal performance.
Immunity test IEC 60601 Test Compliance Voltage Electromagnetic environment - guidance Electrostatic discharge (ESD)
Floors should be wood, concrete or ceramic tile If the floors are covered with synthetic material, the relative humidity should be at least 30%
The input a.c power ports: ±2 kV
The input d.c power ports: ±2 kV
Signal input/output ports: ±1 kV
The input a.c power ports: ±2 kV
The input d.c power ports: ±2 kV
Signal input/output ports: ±1 kV
Mains power quality should be that of a typical commercial or hospital environments
+0.5, +1.0 kV Signal input/output:+2.0 kV ±1 kV differential mode ±2 kV common mode
Mains power quality should be that of a typical commercial or hospital environments
Voltage dips, short interruptions and voltage variations on power supply input lines
25 (50Hz)/30 (60Hz) cycles for 30% UT
250 (50Hz)/300 (60Hz) cycles for >95% UT (sync angle (degrees):0)
25 (50Hz)/30 (60Hz) cycles for 30% UT
250 (50Hz)/300 (60Hz) cycles for >95% UT
For optimal performance, dental X-ray unit image intensifiers should be powered by a reliable mains power source, typical of commercial or hospital settings To ensure uninterrupted operation during power outages, it is advisable to connect the dental X-ray unit to an uninterruptible power supply (UPS) or a battery backup.
To prevent image distortion in dental X-ray units, it may be necessary to relocate the image intensifier away from power frequency magnetic fields or to implement magnetic shielding It is essential to measure the power frequency magnetic field at the installation site to ensure it remains at a sufficiently low level Note that UT refers to the alternating current mains voltage before the test level is applied.
Guidance and manufacturer's declaration − electromagnetic immunity
The dental X-ray unit is designed for operation within a specified electromagnetic environment, and it is the responsibility of the customer or user to ensure that the unit is utilized in accordance with these environmental conditions.
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment − guidance
Professional healthcare environment: 3 V/m Home healthcare environment: 10 Vm
To ensure safety and optimal performance, portable and mobile RF communications equipment must maintain a minimum separation distance from all components of the dental X-ray unit, including cables This distance should be calculated based on the specific frequency of the transmitter used.
Recommended separation distance: d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)
Field strengths from fixed RF transmitter, 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 following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situation Electromagnetic propagation is affected by absorption and reflection from structures, objects and people a b
Field strengths from fixed transmitters, including base stations for cellular and cordless phones, land mobile radios, amateur radio, and AM/FM television broadcasts, cannot be accurately predicted To evaluate the electromagnetic environment caused by these RF transmitters, conducting an electromagnetic site survey is recommended If the measured field strength at the dental X-ray unit's location exceeds the applicable RF compliance level, it's crucial to monitor the unit's performance Should any abnormal operation be detected, further actions may be required, such as readjusting or relocating the dental X-ray unit to ensure proper functionality.
Over the frequency range150 kHz to 80 MHz, field strengths should be less than 3 V/m
Recommended separation distances between portable and mobile RF communications equipment and the dental X-ray unit
The dental X-ray unit is designed for use in environments where radiated RF disturbances are managed To minimize electromagnetic interference, it is essential for users to maintain a safe distance between the dental X-ray unit and portable or mobile RF communication devices, following the recommended guidelines based on the transmitters' maximum output power.
Rated maximum output power of transmitter
Separation distance according to frequency of transmitter m
To estimate the recommended separation distance (d) in meters for transmitters with a maximum output power not specified, use the appropriate equation based on the transmitter's frequency The variable P represents the maximum output power rating in watts (W) as provided by the manufacturer It is important to note that at frequencies of 80 MHz and 800 MHz, the higher frequency range should be considered.
Note 2: These guidelines may not apply in all situation Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.