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

Woodpecker Dental X-ray Device Machine Digital Xray Imaging System

Portable Xray Unit

Product Information

The Dental X-ray Device produced by Guilin Woodpecker Medical Instrument Co., Ltd. is a portable device used to photograph teeth and obtain dental image information. It is designed to be small, light, and easy for doctors to carry. The equipment features a high-quality and efficient user interface, making shooting easier.
It also provides low radiation and high efficiency, ensuring a good user experience.

Model Ai Ray

Configuration The equipment configuration is detailed in the packing list.

Software Title and Version Ai Ray V1

Structure and Components The product is mainly composed of an X-Ray tube, control system, exposure handbrake, battery, power adapter, and beam limiting equipment.

Scope of Application This product is used for X-Ray photography of teeth to obtain images for clinical diagnosis.

Contraindications Pregnant women and young children should not be exposed to the environment for a long time when the product is in use.

Equipment Safety Classification

• Type of operation mode: Continuous operation with intermittent loading
• Type of protection against electric shock: Class II equipment
• Degree of protection against harmful ingress of water: Ordinary equipment (IPX0)
• Degree of safety application in the presence of a flammable anesthetic: Not specified

Schematic Diagram of the Whole Machine

1. Take out all the parts from the packing box. Be careful not to drop or damage the equipment.
2. Take out the power adapter and power line from the packing box and connect them as shown in the figure.
3. Install the exposure handbrake as shown in the figure.
4. Refer to Table 1 for functions of the control panel.

Product Usage Instructions

Installation Follow the steps below to install the Dental X-Ray Device:

1. Take out all the parts from the packing box. Be careful not to drop or damage the equipment.
2. Take out the power adapter and power line from the packing box and connect them as shown in the figure.
3. Install the exposure handbrake as shown in the figure. For wired connection mode, long press the switch of exposure handbrake to start the exposure.
4. Refer to Table 1 for functions of the control panel.

Operation Instruction Follow the instructions below to operate the Dental X-Ray Device:

1. Select the equipment type based on the image receptor for Digital Intraoral X-ray Imaging System, film, or image plate scanner.
2. Select the human body type, either adults or children, for the patients being shot.
3. Select the tooth position for the X-ray photography.
4. Select the connection mode of the exposure handbrake. For wired connection mode, refer to the installation instructions.
5. Monitor the battery power level displayed on the control panel.
6. Use the setting function to adjust the desired settings.
7. Monitor the shooting angle displayed on the control panel.
8. Monitor the X-ray exposure time displayed on the control panel.
9. Observe the X-ray exposure status indicated by different colors on the control panel (normal: not ready, green: ready, yellow: being exposed).
10. Adjust the X-ray exposure time using the time setting function. Use “-” to decrease exposure time and “+” to increase exposure time.

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.

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；

Model

• Ai Ray
• Configuration
• Equipment configuration is detailed in packing list.

Software title and version

• Ai Ray V1

Structure and components

• This product is mainly composed of X-Ray tube, control system, exposure handbrake, battery, power adapter and beam limiting equipment.

Scope of application

• This product is used for X-Ray photography of teeth to obtain images for clinical diagnosis.

Contraindications

• Pregnant women and young children should not be exposed to the environment for a long time when the product works.

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 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.

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: 0.21kw（70kV, 3mA, 0.1s）
   • Nominal electric power: 0.21kw（70kV, 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: Φ6cm±0.6cm
11. Product specifications
    • Dimension: 114mm×363.8mm×245.6mm Weight: 2.4KG
12. Battery specification
13. 8V/2450~2500mAh ×2

Operation environment

• Environment temperature: 10°C ~ 40°C
• Relative humidity: 30% ~ 75%
• Atmospheric pressure: 70kPa ~ 106kPa

Transportation and storage condition

• Storage temperature: -20°C ~ 55°C
• Transportation temperature: -20°C ~ 55°C
• Relative humidity: 10% ~ 93%
• Atmospheric pressure: 70kPa ~ 106kPa

Product installation and function description

Schematic diagram of the whole machine

Accessories installation

Installation area

• Take out all the parts from the packing box. Be careful not to drop or damage the equipment.

Power adapter installation

• Take out the power adapter and power line from the packing box and connect them as shown in the figure.
• [Note] Only the power adapter and power line provided with the equipment can be used

Exposure handbrake

Installation

Note: ① wired connection mode: Long press the switch of exposure hand brake, the exposure starts light on.
Functions of the control panel

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.

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.

Preparation before shooting

1. Turn on the Dental X-ray power switch, and 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 equipment;
3. Select the human body, tooth position and equipment mode;
4. Adjust the exposure time. The system has a default exposure time, or adjusts the shooting time as required;
5. Prepare film or image plate scanner (IP image plate) or Digital Intraoral X-ray Imaging System (sensor).

Shooting images

1. High-quality equipment of image receptors (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 the 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 the image receptor from the patient’s mouth.

Shooting angle

• 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:

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.

Mode function

• When different modes of the equipment, tooth positions and human bodies are selected, the control panel automatically displays the exposure time.

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.

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.

Table 2 Human Body Mode

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.

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.

The setting of exposure time

• If there is required to change the exposure time, click the “±” button to 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.

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

Charging and battery maintenance

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.

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

• 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.
• 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.
• 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;
• 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.
• 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.
• Other safety information can be found in each chapter of this instruction manual. Please read the whole manual carefully.
• 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.
• 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.
• Due to electromagnetic compatibility, the use of other equipment may
  interfere with the our product.

Troubleshooting

• 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.

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.

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.

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;

X-ray tube characteristics

• Filament voltage: 3.0-3.7V
  • Maximum filament current: 3.0A
• Filament frequency: DC/ AC sine wave (0-20kHz)
• Nominal anode input power: 585W (1s)
• Anode heat capacity : 4300J
• Maximum anode heat dissipation: 100W
• O verall 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

Storage, maintenance and transportation

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.

Transportation

1. Avoid excessive shock and vibration during transportation, and handle 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;

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.

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.

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 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.

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:

Connection line of exposure

handbrake

| 8.0m| No| /

• 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.

Guidance and manufacturer’s declaration-electromagnetic emission

Guidance and manufacturer’s declaration-electromagnetic emission

The  Dental X-Ray Device is intended for 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

RF emission CISPR 11

|

Group 1

| The Dental X-Ray Device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic

equipment.

RF emission

CISPR 11

| Group B| 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.

---|---|---
Harmonic emission

lEC 61000-3-2

| Group A
Voltage fluctuation/ flicker emission

lEC 61000-3-2

|

Complied

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

Electrostatic discharge lEC 61000-4-2

|

±6kV contact

discharge

±8kV air

discharge

|

±6kV contact

discharge

±8kV air

discharge

| 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 transient/burst IEC 61000-4-

4

| ±2kV for power supply lines

±1kV for

input/output lines

| ±2kV for power supply lines

±1kV for

input/output lines

|

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

Surge

IEC 61000-4-

4

| ±1kV DMV

±2kV CMV

| ±1kV DMV

±2kV CMV

| Mains power quality should be that of a typical commercial or

hospital environment.

Voltage  dips, short interruptions, and voltage variations on

power supply input lines IEC 61000-4-

11

| <5% UT

(>95% dip in

UT.) for 0.5

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 (50Hz) lEC 61000-4-8|

3A/m

|

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 the application of the test level.

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

Conducted RF

lEC 61000-4-6

Radiated RF

lEC 61000-4-3

| 3Vrms 150kHz

~80MHz 3V/m

80MHz

~2.5GHz

| 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.

• 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.

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 output power of transmitter

/W

| Separation distance according to frequency of transmitter/

m

150kHz~80MHz

d =

| 80MHz~800MHz

d =

| 800MHz~2.5GHz

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

• 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.

Symbol instruction

Statement

Please refer to the product packaging label for the production date, service life: 10 years.

• Guilin Woodpecker Medical Instrument Co., Ltd.
• Information Industrial Park, Guilin National High-Tech
• Zone,Guilin, Guangxi,541004 P.R.China
• Sales Dept: +86-773-5873196/2350599
• After-sales Service Dept: 0773-5827898
• E-mail: woodpecker4@glwoodpecker.com
• Website: http://wwwglwoodpecker.com

Warranty Instruction

Period validity:
Since the date of sale, with a warranty card ,this product enjoys 1 years warranty for the main unit.
Range of warranty:
Within the warranty period of validity, we are responsible for any troubles caused by quality problems or products technique and structure.
The following are beyond our warranty:

1. The damage caused by disobeying the operation instruction or lack of the needed condition.
2. The damage caused by unsuitable operation or disassembly without authorization.
3. The damage caused by unadvisable transportation or preservation.
4. There isn’t the seal of distributor or the warranty card isn’t filled in completed.

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