Dental X-ray Device Machine Digital Xray Imaging System Portable Xray Unit

Contents
Preface————————————————————————- 1 1. Product introduction—————————————————— 1 2. Product installation and function description ————————- 3 3. Operation instruction —————————————————– 5 4. Troubleshooting ———————————————————–11 5 Maintain maintenance—————————————————–12 6 X-ray tube characteristics ————————————————12 8 Storage, maintenance and transportation ——————————14 9. Environment protection ————————————————–15 10. After-sales service ——————————————————-15 11. Electromagnetic compatibility—————————————–16 12 Symbol instruction ——————————————————-21 13 Statement——————————————————————22

Preface
Thank you for purchasing the Dental X-ray Device produced by Guilin Woodpecker Medical Instrument Co., Ltd. Woodpecker is a high-tech enterprise researching, developing, producing and selling Dental products, and it owns a sound quality control system. Please read the full text of the instruction manual carefully to ensure that you can use the equipment correctly and safely.
1. Product introduction
1.1 Product introduction
This equipment is a portable Dental X-Ray Device, which is used to photograph teeth and obtain the Dental image information. Features of this equipment: 1) Small, light, easy for doctors to carry; 2) High quality and efficient user interface, making shooting easier; 3) Low radiation and high efficiency, providing good user experience 1.2 Model
Ai Ray 1.3 Configuration
Equipment configuration is detailed in packing list. 1.4 Software title and version
Ai Ray V1 1.5 Structure and components
This product is mainly composed of X-Ray tube, control system, exposure handbrake, battery, power adapter and beam limiting equipment. 1.6 Scope of application
This product is used for X-Ray photography of teeth to obtain images for clinical diagnosis. 1.7 Contraindications
Pregnant women and young children should not be exposed to the environment for a long time when the product works. 1.8 Equipment safety classification 1. Type of operation mode: Continuous operation with intermittent loading 2. Type of protection against electric shock: Class II equipment 3. Degree of protection against harmful ingress of water: Ordinary equipment (IPX0) 4. Degree of safety application in the presence of a flammable anesthetic
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mixture with air, oxygen, or nitrous oxide: Equipment can’t be used in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. 1.9 Primary technical parameters 1. Power adapter input: 100-240V 50/60Hz 1.5A 2. Internal power supply: DC 10.8V 3. Types of radiation: X-ray 4. Electric power: Maximum power: 0.21kw70kV, 3mA, 0.1s Nominal electric power: 0.21kw70kV, 3mA, 0.1s 5. Tube voltage: tube voltage output is fixed at 70kV, error ±10% 6. Tube current: tube current output is fixed at 3mA, error ±20% 7. Loading time: the exposure loading time adjustment range is 0.02s 2s, the grade is adjustable, the grade is selected according to R’10 numerical system; with deviation ±(10%+1ms) 8. X-ray tube a) X-ray tube model: D-045; b) Focal spot: 0.4mm; c) Target angle: 12.5°; d) Total filtration: 1.5mmAl/70 kV; e) Additional filtration: 0.5mmAl/70 kV 9. Distance from focus to skin: 20cm 10. Output radiation field: 6cm±0.6cm 11. Product specifications Dimension: 114mm×363.8mm×245.6mm Weight: 2.4KG 12. Battery specification 10.8V/2450~2500mAh ×2 1.10 Operation environment
Environment temperature: 10°C ~ 40°C Relative humidity: 30% ~ 75% Atmospheric pressure: 70kPa ~ 106kPa 1.11 Transportation and storage condition
Storage temperature: -20°C ~ 55°C Transportation temperature: -20°C ~ 55°C Relative humidity: 10% ~ 93% Atmospheric pressure: 70kPa ~ 106kPa
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2. Product installation and function description
2.1 Schematic diagram of the whole machine
Figure 1 Schematic diagram of Dental X-Ray Device 2.2 Accessories installation
2.2.1 Installation area Take out all the parts from the packing box. Be careful not to drop or damage the equipment. 2.2.2 Power adapter installation Take out the power adapter and power line from the packing box and connect them as shown in the figure.
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[Note] Only the power adapter and power line provided with the equipment can be used 2.2.3 Exposure handbrake 2.3 Installation
Figure 3 Exposure hand brake Note: wired connection mode: Long press the switch of exposure hand brake, the exposure starts light on. 2.2.4 Functions of the control panel
Figure 4 Control panel 4

Table 1

S/ N Icons

Function

1

Selection of equipment: equipment of image receptor

for Digital Intraoral X-ray Imaging System, film and

image plate scanner (IP image plate)

2

Selection of human body: The patients shot include

adults/ children

3

Selection of tooth position : selection of tooth position

shot.

4

Connection mode: Wired connection mode of the

exposure handbrake

5 Battery power: display of battery power

6 Setting function

7

Display of shooting angle

8

Display of X-ray exposure time

Indication of X-ray exposure status (normal (no

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color): not ready, green color: ready, yellow color:

being exposed)

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Time setting of X-ray exposure , “-” decreases time of exposure , “+” increases time of exposure

3.3.2 Description of Effective Occupied Area The operator should designate any valid occupied area in the place of use, the floor size should not be less than 60cm×60cm, and the height should not be less than 200cm.

3. Operation instruction

The user of the medical device must comply with the requirements of the relevant operating regulations and relevant regulations of the medical department, and is limited to the use of trained doctors or technicians. 3.1 Preparation before shooting
1. Turn on the Dental X-ray power switch, the LCD screen lights up, accompanied by a beeper “di” sound prompt; 2. Check the battery of the equipment to ensure the normal operation of the

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equipment; 3. Select the human body, tooth position and the equipment mode; 4. Adjust the exposure time. The system has a default exposure time, or adjust the shooting time as required; 5. Prepare film or image plate scanner (IP image plate) or Digital Intraoral X-ray Imaging System (sensor). 3.2 Shooting images

1. A high-quality equipment of image receptor (film or IP image plate or sensor) in a sealed protective bag will be put in the patient’s mouth, parallel to the longitudinal axis of the tooth. The effective surface of the equipment of image receptor is facing the tooth; 2. Move the Dental X-Ray Device to the teeth on the patient’s face and adjust the position of the equipment and the patient according to the angle displayed on the screen; 3. Ensure that the light cone of the equipment of image receptor is perpendicular to the position of the IP image plate, press the X-ray machine shooting switch; the exposure key should be pressed for the whole process until the “di” sound prompt of the beeper occurs; 4. When the exposure is finished and the image is taken successfully, remove the equipment of image receptor from the patient’s mouth. 3.3 Shooting angle

3.3.1 Photograph angle reference values Keep the patient in the correct sitting position and adjust the correct shooting angle of the Dental X-Ray Device. The photograph angle reference values are as follows:

Tooth position Maxillary incisor position Maxillary single canine position Maxillary bicuspid and first molar Maxillary second and third molars Mandibular incisor position Mandibular single canine position Mandibular bicuspid and first molar Mandibular second and third molars

X – ray tilt direction Downtilt Downtilt Downtilt Downtilt Uptilt Uptilt Uptilt Uptilt

Angle of tilt +42° +45° +30° +28° -15°
-18°~ -20° -10° -5°

3.4 Software Operation Instructions

This chapter introduces the front panel of the Dental X-Ray Device, which visually displays the operation interface, so that the operator can better use the machine.

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3.4.1 Mode function When different modes of the equipment, tooth positions and human bodies are selected, the control panel automatically displays the exposure time. 1. Equipment Mode Click the icon of equipment selection in the arrow indication in Figure 5 to enter the equipment interface as shown in Figure 6. Select the required equipment of image receptor, and the corresponding area of the equipment is displayed in blue. After the selection is successful, it will automatically exit to the interface in Figure 5, and the device selection icon will change to the corresponding device icon.
Figure 5
Figure 6 2. Human Body Mode After selecting the equipment mode, select human body mode. Click the human body selection icon indicated by the arrow in Figure 7 to switch back and forth between adult and child modes. Different human body models can be selected according to the age of the patient. After the selection is successful, the human body model area will display the corresponding options.
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Table 2 Human Body Mode Icons

Figure 7
Mode Adult Mode

Child Mode
3. Tooth Position Mode Click the tooth position selection icon indicated by the arrow in Figure 8 , enter the interface of the tooth position as shown in Figure 9. Select the tooth type to be shot, and the corresponding area of the tooth is displayed in blue. After the selection is successful, it will automatically exit to the interface in Figure 8, and the tooth position selection icon will change to the corresponding tooth position icon.

Figure 8 8

Figure 9 3.4.2 Setting function Click the setting icon indicated by the arrow in Figure 10 to enter the setting interface. Different languages and factory modes can be set as shown in Figure 11. After the setting is successful, it will automatically exit to the Figure 10 interface.
Figure 10
Figure 11 3.4.3 Setting of exposure time If there is required to change the exposure time, click the “±” button to
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adjust the exposure time from 0.04 second to 1 second. The exposure time can be adjusted from 0.04 seconds to 1 second in 15 steps. 3.4.4 Exposure 1. Long press the exposure switch of Dental X-Ray device to carry out exposure. See Table 3 for different states of exposure icons on the screen. 2. Long press the exposure button on the exposure handbrake to carry out exposure. During exposure, the exposure indication light of the exposure handbrake will be on. See Table 3 for different states of the exposure icon on the screen. Table 3

Exposure icon

State

Not ready

Being exposed

Ready
3.5 Charging and battery maintenance
3.5.1 Charging 1. Connect one end of the charger to the charging port of the equipment and the other end to the power supply of the network (100-240V, 50/60Hz); 2. When charging, the equipment displays the charging icon, and when charging is finished, the battery is charged fully; 3. Disconnect the power supply and the charger when the charging is complete; 4. A single charge takes about 4 hours. 3.5.2 Battery maintenance 1. When the machine is not in use, the power switch should be turned off to save electrical energy; 2. Please use the original charger to charge; 3. Separate the battery from the equipment when it is not used for a long time, and charge it once every three months; 4. Keep the electrical energy more than 20%; 5. High position and single charge over 12 hours should be avoided; 6. Avoid exposing the battery to high temperature or fire, and avoid direct sunlight when storing the battery. 7. If you find that the battery life cannot meet the needs of use, please contact the manufacturer and authorized dealers in time to replace the new battery.Notes
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3.6 The Dental X-Ray Device shall never be used in the presence of flammable anesthetic gas, pure oxygen or nitrogen oxide to avoid any risk of explosion. 3.7 Patients and operators are advised to wear radiation protector when taking X films; and the distance between the operators and Dental X-Ray Device components should be 2m. 3.8 Dental X-Ray Device and its accessories have been designed and developed to ensure the highest level of safety and performance. The use of accessories not provided by the original manufacturer may pose a risk to patients, users or the equipment itself; 3.9 The equipment complies with the IEC 60601-1 standard. Only peripheral equipment conforming to IEC 60950-1 can be connected to it so as to avoid any risk of failure of the Dental X-Ray Device. 3.10 Our company is specialized in the production of medical equipment. We are responsible for the safety of the equipment only when the maintenance, repair and modification of the machine are carried out by our company or by our authorized dealers, and the replacement parts are our Woodpecker accessories and operated according to the operating instructions. 3.11 Other safety information can be found in each chapter of this instruction manual. Please read the whole manual carefully. 3.12 In order to ensure safe and correct operation and use of the Dental X-Ray Device, it is quite important to use the charger provided by the equipment. The power line of the Dental X-Ray Device can only be replaced by the same type of line. 3.13 Due to the electromagnetic compatibility of X-ray generator, other equipment nearby may be affected during the use. There is a risk of malfunction of nearby equipment. 3.14 Due to electromagnetic compatibility, the use of other equipment may
interfere with the our product.

4. Troubleshooting

Fault

Reason

Solution

Exposure button is not Press the exposure button

pressed all the time

once and use it after the

during exposure

warning disappears

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The temperature of

Equipment is cooled down

equipment is too high before use

The voltage of equipment is too high

Restart the machine, if the fault still exists, please contact the manufacturer

If the above methods can not eliminate the fault, please contact the distributor to return the equipment to the manufacturer for handling. Do not try to open the casing of this equipment and repair it yourself.
5 Maintain maintenance
Before the first use of this equipment, a complete cleaning procedure must be followed. The Dental X-Ray Device should be disconnected from the power supply before cleaning and disinfection each time. 5.1 Cleaning
a) Wipe the shell of the product and the head of the X-ray machine with non-abrasive materials (gauze and soft cloth) dipped with detergent, and pay attention not to allow liquid to flow into the equipment; b) Dry the equipment with a clean, dry and soft cloth. 5.2 maintainance
a) Immerse a piece of clean dry gauze in 70% -80% ethanol disinfectant, and then wipe the disinfected parts twice with soaked dry gauze; b) Dry the equipment naturally or with a clean, dry and soft cloth. Caution: Do not use the following methods of disinfection a) Do not use organic solvents or corrosive cleaning products to clean the Dental X-Ray Device; b) Do not spray detergent directly on the Dental X-Ray Device; c) Do not use organic solvent or corrosive disinfectant to disinfect the Dental X-Ray Device; d) Do not spray disinfectant directly on the Dental X-Ray Device;
6 X-ray tube characteristics
Filament voltage: 3.0-3.7V Maximum filament current: 3.0A
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Filament frequency: DC/ AC sine wave (0-20kHz) Nominal anode input power: 585W (1s) Anode heat capacity: 4300J Maximum anode heat dissipation: 100W Overall dimension and wiring: as shown in Figure 12 Maximum rated value: as shown in Figure 13 Thermal characteristics: see Figure 14 Filament and emission characteristics: see Figure 15
Figure 12 Mechanical dimension machine wiring
Figure 13 Maximum rating diagram
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Figure 14 X-ray tube anode heating and cooling curve
Figure 15 Filament and emission characteristic curve
8 Storage, maintenance and transportation
8.1 Storage/ maintenance 1) The equipment shall be handled with care, away from the hypocenter, and shall be installed or stored in a cool, dry and ventilated place. 2) Do not store with toxic, corrosive, flammable and explosive substances. 3) When the equipment is not used for a long time, turn off the power switch and unplug the power plug. 4) The product shall be stored in an environment with relative humidity of 10% -93%, atmospheric pressure of 70kPa ~ 106kPa and temperature of -20 °C ~ + 55 °C. 5) Inspect the equipment for scratches, wear and other mechanical scratches or damage after each use.
8.2 Transportation 1) Avoid excessive shock and vibration during transportation, and handle 14

with care to avoid inversion; 2) It shall not be mixed with dangerous goods during transportation; 3) Avoid sun exposure or rain and snow immersion during transportation;

9. Environment protection

This equipment can’t be disposed of as household waste. Therefore, this equipment should be placed in a special recycling place for waste electronic medical equipment. For more detailed information about equipment disposal and recycling, please contact the Dental equipment dealer.

Part

Toxic or harmful substances or elements (Pb) (Hg) (Cd) (Cr6+) (PBB) (PBDE)

Power adapter

Main unit

Mechanical

elements,

including bolts,

nuts, washers, etc.

: Indicates that the content of the toxic substance in all homogeneous

materials of the part is below the limit requirement stipulated in SJ/T-11363-

2006 “Marking for Control of Pollution Caused by Electronic Information

Products”.

×: Indicates that the content of the toxic substance in at least one of the

homogeneous materials of the part exceeds the limit requirement specified in

SJ/T-11363-2006.

(This product meets EU RoHS environmental protection requirements;

there is currently no mature technology in the world to replace or reduce

the content of lead in electronic ceramics, optical glass, steel and copper

alloy.) According to the “Administrative Measures on the Restriction of the

Use of Hazardous Substances in Electric and Electronic Products” and the

“Regulations on the Administration of the Recycling and Disposal of waste

Electrical Appliances and Electronic Products” and related standards, please

observe the safety and precautions of the products, and please recycle or

dispose this product according to the methods in local laws and regulations

after use.

10. After-sales service
Since the date of sale, if the equipment fails to work normally due to quality problems, our company will be responsible for the maintenance

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based on the warranty card. Please refer to the warranty card for the warranty period and scope. This product does not contain self-maintained parts, and the maintenance of this equipment should be carried out by designated professionals or special repair shops.

11. Electromagnetic compatibility

For this equipment, special precautions regarding electromagnetic compatibility (EMC) must be taken, and the installation and use must be performed according to the electromagnetic compatibility information specified in this manual. Portable and mobile radio frequency communication equipment may affect this equipment. The following cables must be used to meet electromagnetic emission and anti-interference requirements:

Name Power adapter cable DC cable Connection line of exposure handbrake

Cable length 1.2m 1.5m 8.0m

Shielded or not No No No

Remark / / /

In addition to cables (transducers) sold as spare parts of internal components, the use of accessories and cables (transducers) other than those specified may result in increased emission or reduced immunity of the equipment or system. The equipment or system should not be used close to or stacked with other equipment. If it is required to be used in this way, it should be observed to verify that it can operate normally under the configuration used. 11.1 Guidance and manufacturer’s declaration-electromagnetic emission

Guidance and manufacturer’s declaration-electromagnetic emission

The Dental X-Ray Device is intended for the use in the electromagnetic

environment specified below. The customer or the user should assure that it

is used in such an electromagnetic environment.

Emission test Compliance Electromagnetic environment-guidance

The Dental X-Ray Device uses RF

energy only for its internal function.

RF emission CISPR 11

Group 1

Therefore, its RF emissions are very low and are not likely to cause any

interference to nearby electronic

equipment.

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RF emission CISPR 11

Group B

Harmonic emission lEC 61000-3-2

Group A

Voltage fluctuation/

flicker emission Complied

lEC 61000-3-2

The Dental X-Ray Device is suitable for used in all establishments, including domestic establishments and establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

11.2 Guidance and manufacturer’s declaration-electromagnetic immunity

Guidance and manufacturer’s declaration-electromagnetic immunity

The Dental X-Ray Device is intended for the use in the electromagnetic

environment specified below. The customer or the user should assure that it

is used in such an electromagnetic environment.

Immunity test Test level

Compliance level

Electromagnetic environment – guidance

Floors should be wood,

Electrostatic discharge lEC 61000-4-2

±6kV contact discharge ±8kV air discharge

±6kV contact discharge ±8kV air discharge

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

%.

±2kV for

±2kV for

Electrical fast power supply

transient/burst lines

IEC 61000-4- ±1kV for

4

input/output

power supply lines ±1kV for input/output

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

lines

lines

Surge IEC 61000-44

±1kV DMV ±2kV CMV

±1kV DMV ±2kV CMV

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

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Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-411

<5% UT (>95% dip in UT.) for 0.5 cycle 40 % UT (60% dip in UT.) for 5 cycles 70 % UT (30% dip in UT.) for 25 cycles 95% dip in UT.) for
5s

<5% UT (>95% dip in UT.) for 0.5 cycle 40 % UT (60% dip in UT.) for 5cycles 70 % UT (30% dip in UT.) for 25cycles 95% dip in UT.) for
5s

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

Power frequency magnetic field 3A/m (50Hz) lEC 61000-4-8

3A/m

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

NOTE: UT refers to the AC mains voltage prior to application of the test level.

11.3 Guidance and manufacturer’s declaration-electromagnetic immunity

Guidance and manufacturer’s declaration-electromagnetic immunity

The Dental X-Ray Device is intended for the use in the electromagnetic

environment specified below. The customer or the user should assure that it

is used in such an environment.

Immunity test

Test level

Compliance level

Electromagnetic environment – guidance

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Conducted

RF

3Vrms

lEC

150kHz

61000-4-6 ~80MHz

Radiated 3V/m

RF

80MHz

lEC

~2.5GHz

61000-4-3

3Vrms 3V/m

Portable and mobile RF communication equipment should be used not closer to any part of the Dental X-Ray Device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 150kHz~80MHz
d = 80MHz~800MHz d = 800MHz~2.5GHz where “P” is the maximum output rated power of the transmitter provided by the transmitter manufacturer in watts (W) and “d” is the recommended separation distance in meters (m). Field strengths of b fixed RF transmitters is determined by an electromagnetic site survey of a, and frequency range b should be less than the compliance level in each. Interference may occurs in the vicinity of equipment marked with the following symbol:

NOTE1: At 80 MHz and 800 MHz, the formula of higher frequency range is applied. NOTE2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by the absorption and emission from buildings, objects and human bodies.

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a. Field strengths of a fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dental X-Ray Device is used exceeds the applicable RF compliance level above, the Dental X-Ray Device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dental X-Ray Device. b. In the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
11.4 Recommended separation distances between RF communications equipment and Dental X-Ray Device

Recommended separation distances between portable and mobile RF

communications equipment and the Dental X-Ray Device

The Dental X-Ray Device is intended for use in electromagnetic

environment in which radiated RF disturbances are controlled. The customer

or the user of the Dental X-Ray Device can help prevent electromagnetic

interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the Dental X-Ray

Device as recommended below, according to the maximum output power of

the communications equipment.

Rated maximum Separation distance according to frequency of transmitter/

output power

m

of transmitter 150kHz~80MHz 80MHz~800MHz 800MHz~2.5GHz

/W

d =

d =

d =

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

20

For the rated maximum output power of transmitters not listed in the above table, the recommended separation distance “d” (m) can be determined by the formula in the corresponding transmitter frequency column. Where “P” is the maximum output rated power of the transmitter in watts (W) provided by the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the formula of higher frequency range is applied. NOTE 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by the absorption and emission from buildings, objects and human bodies.
Notes: Without the explicit consent of Woodpecker, unauthorized changes or modifications to the equipment may cause electromagnetic compatibility problems of this equipment or other equipment.
12 Symbol instruction

Manufacturer
Attention!Access to accompanying files Class equipment

Serial number Item number Ordinary equipment

Avoid sun exposure

Products comply with WEEE directive

Danger! High voltage
Date of manufacture Products comply with WEEE directive

Electrostatic Discharge Sensitive Device (ESDS) X-ray, beware of ionizing radiation
Follow the manual

Humidity limit for storage: 10% ~ 93%

Atmospheric pressure for storage: 70kPa ~ 106kPa

Temperature limit for storage: -20°C ~ +55°C

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13 Statement
Please refer to the product packaging label for the production date, service life: 10 years.
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ZMN-SM-661 V1.2- 20220414