GUILIN WOODPECKER F2 Ai Ray Dental X-Ray Device Instruction Manual

GUILIN WOODPECKER F2 Ai Ray Dental X-Ray Device

Specifications

• Model: Ai Ray
• Configuration: Detailed in packing list
• Software title and version: Ai Ray V1
• Structure and components: X-ray tube, control system, exposure handbrake, battery, power adapter, beam limiting equipment
• Scope of application: X-ray photography of teeth for clinical diagnosis
• Contraindications: Pregnant women and young children should not be exposed to the environment for a long time during operation
• 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

FAQs

• Q: Is the Dental X-ray device safe for pregnant women?
  • A: Pregnant women should not be exposed to the environment for a long time when the product is in operation.
• Q: What is the recommended age for patients to undergo X-ray photography using this device?
  • A: This device can be used for patients of all ages but special care should be taken for young children.

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

• Product introduction
  • This equipment is a portable Dental X-ray device, which is used to photograph teeth and obtain 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 a good user experience；

• Model
  • Ai Ray
• Configuration
  • Equipment configuration is detailed in the packing list.
• Software title and version
  • Ai Ray V1
• Structure and components
  • This 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 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, and the grade is selected according to the 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** 10.8V/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: ①wired connection mode: Long press the switch of exposure hand brake, the exposure starts light on.
• Functions of the control panel

Table 1

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, 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 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).

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 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 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, and 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 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.

Setting of exposure time
If there is required to change the exposure time, click the “±” button to adjust the exposure time from 0.04 seconds 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 the 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 at more than 20%;
5. High position and single charge over 12 hours should be avoided;
6. Avoid exposing the battery to high temperatures 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 protectors when taking X films, and the distance between the operators and Dental X-ray device components should be ≥2m.
   • Dental X-ray devices and their 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 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 are 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.
   • 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 the 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 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;

6 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
• 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

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, or 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 a 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.

○: 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 of 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:

• 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 with nearby electronic equipment.
RF emission CISPR 11| Group B| The Dental X-ray device is suitable for use 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 ensure 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 cycles 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 before 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 use in the electromagnetic environment specified below. The customer or the user should ensure 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 fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts 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 for this equipment or other equipment.

Symbol instruction

Statement

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

Cut along the dashed line
Dental X-Ray Device Warranty Card

• 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://www.glwoodpecker.com

Dental X-Ray Device Warranty Card

• 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://www.glwoodpecker.com.

Warranty Instruction

1. Period validity:
   • Since the date of sale, with a warranty card, this product enjoys 1 years warranty for the main unit.
2. Range of warranty:
   • Within the warranty period of validity, we are responsible for any troubles caused by quality problems or product technique and structure.
3. The following are beyond our warranty:
4. The damage caused by disobeying the operation instructions or lack of the needed condition.
5. The damage is caused by unsuitable operation or disassembly without authorization.
6. The damage caused by unadvisable transportation or preservation.
7. There isn’t the seal of the distributor or the warranty card isn’t filled in completed.

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CONTACT INFORMATION

• Guilin Woodpecker Medical Instrument Co., Ltd.
• Information Industrial Park, Guilin National High-Tech
• Zone, Guilin, Guangxi, 541004 P. R. China
• Tel:
  • Europe Sales Dept.: +86-773-5873196
  • North/South America & Oceania Sales Dep.: +86-773-5861105
  • Asia & Africa Sales Dep.: +86-773-2350599
  • Fax: +86-773-5822450
• E-mail: woodpecker@g|woodpecker.com, sales@glwoodpecker.com
• Website: http://www.glwoodpecker.com
• ZMN-SM-661 V1.2- 20220414
• F2 Medical Supplies Ltd
• T: 0116 319 1182
• E: sales@f2medicalsupplies.com.

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