Bella Ink Pro ND-YAG PRO X Tattoo Removal Laser with Cold Air Blower User Manual

Bella Ink Pro ND-YAG PRO X Tattoo Removal Laser with Cold Air Blower

Product Information

Specifications

• Product Name: Nd: YAG Laser Bella Ink Pro
• Model: ND-YAG PRO X
• Manufacturer: Beijing UNT Technology Co., Ltd
• Power Supply: 100~130VAC(50/60Hz) or 210~240VAC(50/60HZ) single-phase

Product Usage Instructions

User Information
Before using the Nd: YAG Laser, it is essential for the operator to carefully read the user manual to ensure the equipment’s functions are working correctly to prevent damage. If connecting peripheral devices, refer to their manuals for detailed instructions.

Safety Warnings

• Avoid high EMI intensity and RF shielding chambers of ME systems.
• Ensure the machine can be safely turned off by placing it where power supply disconnection is easy.
• Avoid using the device adjacent to or stacked with other devices to prevent improper operation.
• Only use accessories specified by the manufacturer to maintain proper operation.
• Maintain a distance of at least 30 cm between portable RF communication equipment and the laser apparatus.
• Take mitigation measures if using the device in a residential environment requiring CISPR 11 class B protection.
• Avoid modifying the equipment without authorization.

Chapter 1 User Information

Before using the machine, the operator must read the user manual carefully and check whether the various functions of the equipment are working properly to avoid unnecessary damage. If the operator need to connect the device to the peripheral device, the operator must read the instruction manual of the peripheral device in detail.

Safety warming

• Warning: Do not approach active HF surgical equipment with high EMI intensity and RF shielding chambers of ME systems used for magnetic resonance imaging.
• Warning: Do not put the machine in the place where it is difficult to disconnect the power supply, so that the machine can be turned off safely.
• Warning: Do not use this device adjacent to or stacked with other devices. Otherwise, improper operation may occur. If necessary, observe the device and other devices to confirm the normal operation.
• Warning: Use accessories, transducers and cables that not specified or provided by the manufacturer of this equipment may increase electromagnetic radiation or reduce electromagnetic immunity of this equipment and lead to improper operation.
• Warning: Portable RF communication equipment (including antenna cables and peripherals such as external antennas) should be at least 30 cm (12 inch) away from any part of the ND-YAG laser therapeutic apparatus, including cables specified by the manufacturer. Otherwise, the device performance may deteriorate.
• Note: The emission characteristics of this equipment make it suitable for industrial areas and hospitals (CISPR class 11 A). If used in a residential environment, which typically requires CISPR 11 class B, this device may not provide adequate protection for RF communications services. Users may need to take mitigation measures, such as repositioning or redirecting the device.
• Warning: During the equipment use, the equipment may cause risks due to mutual interference and it may also cause external electromagnetic interference to other equipment.
• Warning: It is forbidden to modify the equipment without authorization. The maintenance personnel of the equipment need to pass the special training of the company.
• Disclaimer: The manufacturer can provide the schematic diagram for maintenance upon request.

Safety measures
During emergency situations, tap the emergency stop switch, turn off the device.

User training
Only the people who had been professional trained to understand the treatment effect and know the potential risks then can use the device. The operator must read the user manual carefully before operating the device. During treatment, treatment rooms should be marked with “non-related personnel are forbidden” words. Before the treatment, the operator must be informed of the possible risks during treatment. The success of treatment depends on the operator’s experience and understanding of professional knowledge. During treatment, the operator must wear protective glasses, treated subjects wearing safety goggles, do not wear glasses which cannot meet the security needs.

Electro mechanical safety of equipment
Device power supply used 100~130VAC(50/60Hz) or 210~240VAC(50/60HZ) single- phase power supply, equipment by three line contact with the ground, the ground must ensure reliable grounding. Only authorized personnel can repair the device, otherwise it will cause warranty invalid.
Notice：In the operating range, avoid to use flammable substances, such as acetone, alcohol. When using alcohol-based products to disinfect equipment, make sure that the alcohol evaporate completely before device operation.

Chapter 2 Product Introduction

Product description
Model ND-YAG Pro X is a kind of laser pigment therapy device. It works by “light lasting”. Laser emits high-energy in a moment, The pigments particles absorb the laser energy, then rapidly expanding burst, part of the pigments burst exploded into tiny nibs excreted out of the body, another part of pigments was swallowed by human body macrophages and excreted through the lymphatic system, so that reached pigment faded and even the complete elimination purposes.

Product structure and properties

As the picture 2-2-1 shows, ND-YAG Pro X mainly composited by host, the operation handle and foot switch. The operation handle is the treatment handle.

Host
For a device, main frame is the carrier of the other product components. ND- YAG laser machine main frame generally consists of the following components: power module, control module, display module:

Power Module
Power Module: The entire device system power supply, the main power source of the device working.

Control Module
Control Module: The operation of the instrument is mainly completed through the control module, which mainly includes the following parts:
Key Switch: Start the device so that the device connected to the power supply.

Emergency stop switch
When an emergency fault occurs or operator error, press the power switch to enable the device to stop working, to protect device and people.

Display Module：
Control screen：As a man-machine interface, it can display setting of operation and adjust system parameters.

Foot switch:
Foot switch: Depresses the foot switch, the device begins to work. Lift up the foot switch, the device stops working.

Operation handle
The operating handle is the main body of the operation and is the applied part of the machine, which includes a bellows and a treatment head. The bellows are equipped with power cables and data cables. The treatment handle is equipped with a control switch, as the picture 2-2-2 shows:

The operating handle is the main body of the operation and is the applied part of the machine, which includes a bellows and a treatment head. The bellows are equipped with power cables and data cables. The treatment handle is equipped with a control switch, as the picture shows:
ND-YAG have four kinds laser wavelength: 1064nm, 532nm, 1320nm and 755nm, 1064nmwavelength which is mainly used on the skin to get rid of blue, black pigmentatio n, 532nmwavelength mainly used to get rid of the skin red, brown pigmentation. The laser h ead of the 1064 nm wavelength laser treatment handle is circular, the laser head of the 532nmwavelength laser treatment handle is square and the laser head of the 1320nm is honeycomb shaped for skin whitening.

Product technical parameters
Table 2-2-1 Product technical parameters

Intended use of the product: Applicable people and places
Eliminate endogenous pigment: nevus, dark spots, age spots, freckles. Eliminate exogenous pigment: tattoo on eyebrow, eye line, lip line, and traumatic tattoo.
Applicable places: hospitals, clinics, and beauty salons with medical qualifications; Surgery used types: single wavelength laser treatment, non- embedded.

Product Accessories
ND-YAG Pro X’ accessories composition as shown in table：

1

| Footswitch| 1
Cross screwdriver| 1| Funnel| 1
Plastic hose|

1

| Operator protective glasses| 1
---|---|---|---
Treated subjects goggles|

1

| 500ml measuring glass| 1
1064nm laser head|

1

| 532nm laser head| 1
1320nm laser head| 1| |

Label instructions

Chapter 3 Equipment Installation

Equipment installation process
Device should be installed in a non-corrosive gases, dust, particles less environment, Corrosive gases will damage electronic devices, optical components, connecting wires. Dust and larger particles in the air, will damage filters and electrical components. Installing environment temperature, humidity range should be consistent with the requirements of the technical parameters of the device.

Installation of process device:

• The device taken out.
• Taken out the device for one day, because of long-distance transportation, device may be excessive humidity, so that avoid resulting in device damage.
• After device proper humidity, assembling the various components to ensure that all connections are secure interface.
• Let the tank is filled with distilled water.
• Device’s Hand piece and power connections.
•  After various parts and power connection was completed, to ensure the device is connected correct the situation, open the device, testing of all system parameters and performance

Equipment installation and injection instructions

Water Injection instructions
When install the parts of the device, the first to be is water injection operation, before run the device each time, must check the water injection position’s water level mark whether is above the blue sign the water column or not. If do not reach it must be distilled water refilling.

Water injection instructions
When the device start to work the ambient outside temperature best at 15 ℃ ~ 30 ℃; wetness can not be higher than 80%; treatment room should always be kept clean.
Before filling with water, make sure that the ventilation hole is open and the handle is fully assembled (Picture 3.2.3 Therapeutic Handle Installation), otherwise it will not fill in water, as picture 3-2-1 shows:

Insert the white connector of the water injection funnel into the water injection hole and inject water into the device through the funnel. When the water level on the water injection pipe reaches H or water overflows, the water injection is complete, as picture 3-2-2 shows:

After water injection, press the iron sheet on the water injection/drain hole to remove the water injection device from the water injection hole, as picture 3-2-3 shows:

Water cycling debugging
After the device water injection completed, then connected the power line and foot line, then begin to do water cycle debugging test.

Water cycle debugging running steps as follows:
Before device starts to work, must ensure that the emergency stop switch in the up state. If the emergency stop switch is pressed, please click on the emergency stop button, keep it in the up state.

• Keep the rear of device’s circuit breaker switch to the “ON” position.
• Press the button switch, device internal water cooling system runs automatically. Observation of the water cycle is running correctly or not.
• If no leaks, water flow alarm, etc, let device work more than one minute, then turn off the power. It proves water cycle debugging is work well.
• Notice：Every 1-2 months changing the water inside the device,as much as possible to discharge all remaining water in the cooling system.

Treatment handle installation
When install the handle, need to lower than the machine height,in order to discharge bubble from the handle.After installed,start the device,let the water circulation run for at least one minute, then can do treatment.
As the 3-2-4 shows: align the hand with the interface, rotate clockwise, insert the handle socket completely and lock it. The socket connection is complete.
To remove the hand, rotate counterclockwise and pull it out. The treatment handle can be removed.

Chapter 4 Equipment software operating instructions

Interface display and instruction

As picture 4-2-1 shows: click ND-YAG to enter the system automatically generates the required parameters, click work, you can use.

System setting interface description

Work Interface

Working interface description
Table 4-1-1 Working Interface Description

Table 4-1-2 Working Interface Description

Indicator icon alarming description

Water level alarm

• When the water level alarm icon is displayed in red and “!” appears, it means that the water level is in the alarm state, and the water level of the water tank is too low.
• Handling method：Add water in time.

Water tank temperature alarm

• When the value displayed in the water tank temperature indicator icon is too high and “!”appears in the icon. , indicating that the water tank temperature alarm, the system automatically switches to standby state. The default factory alarm temperature of the water tank is set to 45℃.
  Handling method：Check whether the components of the water circulation system work properly and there is no damage. If the above situation does not occur, please contact the dealer.
  Handling method：Check whether the hand is properly and firmly inserted. If the socket is not firmly inserted, please contact after-sales maintenance personnel.

Water flow alarm
When the value displayed by the water flow indicator icon is less than “1” and the water drop in the icon is lit, it indicates water flow alarm, and the system automatically switches to standby state. The flow alarm is set to 2L/min by default.
Handling method：Observe the water label to see if there is enough water or check the connection between the treatment handle and the device for leaks.
If the above situation does not occur, please contact after-sales maintenance personnel.

Treatment interface operation instructions
Standby/working state switch Click the “standby/work” button, if the system is in the standby state, it will switch to the working state; if the system is in the working state, it will switch to the standby state. The button is gray in the standby state, and the button is green in the working state.

Detailed operations on the equipment

• Before treatment, the operator should communicate with the treatment object in detail, use a mild cleanser to clean the treatment area, wipe the treatment area with anhydrous cotton cloth, and ensure that the treatment area is dry and not damp. Start the system and enter the treatment parameter setting interface; Select according to the actual situation of the treatment object, set the treatment parameters, and click the standby/work button to enter the working state;
• When the treatment head is in working state, it is strictly forbidden to make the light outlet of the treatment head aim at the human eyes. Before the treatment, the operator should wear protective glasses, and the treated person should wear goggles.
• During the treatment process, the operator should observe the treatment situation of the treatment object in real time, and if necessary, adjust the treatment parameters according to the actual situation;
• During the treatment process, the treatment head should avoid staying in the same treatment site for a long time; bleeding may occur after treatment. The ND-YAG Pro X is an exfoliative treatment method, and bleeding is a normal phenomenon.
• After the treatment, turn off the power switch; the treatment area can be wiped with an anhydrous cotton swab.
• Clean the treatment head with a warm towel, and then disinfect the treatment head with a cotton ball dipped in disinfectant;
• Put the cleaned and sterilized treatment head into the transport box, unplug the device, and the treatment process is over.

Precautions and contraindications

During treatment, the treatment head should not stay in the treatment site for too long;
For the treatment area, do not touch the water for 72 hours, and avoid sauna bathing and sweating for 3 to 7 days;

Avoid high humidity and heat environments

Avoid spicy, seafood, and spicy foods; eat less photosensitive vegetables (for example, celery, white radish, spinach, coriander, etc.)
Pay attention to sun protection and prevent sweating. If the ultraviolet rays are strong in summer, use a sunshade or wear a sun hat;  Children, pregnant women, and lactating women should not use the machine； Those with scar constitution and light sensitivity are not allowed to use this machine;
The use of functional cosmetics on the treatment area is prohibited within the past  month.

Chapter 5 Requirements for EMC equipment

Notice:
Buyers or users should use this product in the electromagnetic environment specified in Table 1-4-2, Table 1-4-3, Table 1-4-4, and Table 1-4-5, otherwise the product may not work properly Work.
Portable and mobile radio frequency communication equipment may affect the normal use of this product, please use this product in the recommended electromagnetic environment.

Warming:
In addition to the accessories and cables provided by the manufacturer of this product (Table 1-4-1), the use of unspecified accessories and cables may result in an increase in the emission of this product or a decrease in the immunity.

This product should not be used close to or stacked with other equipment. If it must be used close to or stacked, it should be observed to verify that it operates normally in the configuration it is used in.

Table 1-4-2

This product is intended to be used in the electromagnetic environment specified below, and the purchaser or user should ensure that it is used in this electromagnetic environment:

Launch test| Compliance| Electromagnetic Environment – Guide
RF emissions CISPR 11| Group 1|

This product uses radio frequency energy only for its internal function. Therefore, its RF emissions are low and the potential to cause interference to nearby electronic equipment is low.

RF emissions CISPR 11| Class A| This product is suitable for use in non- domestic and all installations not directly connected to the public low- voltage power supply network of domestic residences.

Harmonic emission IEC 61000-3-2

| not applicable
Voltage fluctuation/flicker emission IEC 61000-3-3| not applicable

Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions

Table 1-4-3

Guidelines and Manufacturer’s Declaration – Electromagnetic Immunity

This product is intended to be used in the electromagnetic environment specified below, and the purchaser or user should ensure that it is used in this electromagnetic environment:
Immunity test| IEC 60601 test electric level| Compliance electric level| Electromagnetic Environments – Guidelines
Electrostatic discharge

IEC 61000-4-2

| ±8kV contact discharge

±15 kV air discharge

| ±8 kV contact discharge

±15 kV air discharge

| Floors should be wood, concrete or tile, and if covered with synthetic materials, the relative humidity should be at least 30%.
---|---|---|---
Electrical fast transient burst(EFT)| ±2 kV pair of power line

Cord ±1 kV pair of input/output lines

| ±2 kV pair of power line

Cord ±1 kV pair of input/output lines

| Mains power should be of the quality used in a typical commercial or hospital environment.
Surging IEC 610004-5| ±1 kV Wire to Wire

±2 kV line-to-earth

| ±1 kV Wire to Wire

±2 kV line-to-earth

| The grid power supply should be of the quality typically used in a commercial or hospital environment.
---|---|---|---
Power input line voltage, temporary outages and voltage changes

IEC 61000-4-11

| 0% UT for 0.5

cycles at 0°, 45°,

90°, 135°,

80°,225°, 270°

and 315°0% UT for 1

cycle, 70% UT, Lasts 25/30 cycles; Single phase: at 0°, 0%

UT. 250/300 cycle

| UT by 0% for 0.5

cycles in 0 °, 45 °,

90 °, 135 °, 180 °,

225 °, 270 ° and 315 °

0% UT for 1 cycle,

70% UT for 1 cycle 25/30 cycle; Single phase: 0% UT at 0°; 250/300 cycle

| Mains power should be of the quality used in a typical commercial or hospital environment. If the user of this product requires continuous operation during power interruptions, an uninterruptible power supply is recommended for

this product.

Power frequency magnetic field（50 Hz/ 60 Hz）

IEC 61000-4-8

| 3 A/m

50Hz/60Hz

| 3 A/m

50Hz/60Hz

| The power frequency magnetic field should have the characteristics of the power frequency magnetic field level of a typical location in a typical commercial or hospital environment.
---|---|---|---
Note: UT refers to the AC network voltage before the test voltage is applied.

Table 1-4-4

Guidelines and Manufacturer’s Statement – Electromagnetic Immunity

This product is intended to be used in the electromagnetic environment specified below, and the purchaser or user shall guarantee its use in such electromagnetic
Immunity test| IEC 60601

test level

| match level| Electromagnetic Environments – Guidelines
The radio frequency transmission

IEC 61000-

4-6

| 3 V（RMS）

150 kHz～

80 MHz

6 V ISM

frequency range

150 kHz～

80 MHz

| 3 V（RMS）

150 kHz～

80 MHz

6V ISM

frequency range

150 kHz～

80 MHz

| Portable and mobile RF communications equipment should not be used closer than the recommended isolation distance to any part of this product, including cables. The distance shall be calculated by a formula corresponding to the transmitter frequency. Recommended isolation distance.d      P—According to the transmitter manufacturer’s maximum rated transmitter output power, in watts
Radio frequency radiation IEC 61000-

4-3

| 3 V/m

80 MHz～

2.7GHz

| 3 V/m

80 MHz～

2.7GHz

| (W)；d—Recommended isolation distance,    in meters (m).

The field strength of the stationary RF transmitter passes through the electric pair The magnetic field measured by a is determined at each frequency range b should be lower than the conforming level.Interference may occur near devices marked with the following symbols.

---|---|---|---
Notice

1. At 80 MHz and 800 MHz, the formula for the higher frequency band is used.
2. Notice    2 ： These guidelines may not be suitable for all situations. Electromagnetic transmission is affected by buildings, objects and people and effects of absorption and reflection.

• Fixed transmitters, such as base stations for wireless (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasting, and television broadcasting, have field strengths that cannot be predicted theoretically with accuracy. To assess the electromagnetic environment of fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where this product is located is above the applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product.

Recommended isolation distance between portable and mobile RF communication equipment and the product.

This product is intended for use in electromagnetic environments where RF radiation disturbance is controlled. Based on THE maximum rated output power of the communication equipment, the purchaser or user may prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF

communication equipment (transmitter) and the product as recommended below.

Maximum rated output power of the transmitter: W| The isolation distance of different frequencies of the corresponding transmitter /m
150 kHz～80 MHz

d      1.2 P

| 80 MHz～800 MHz

d      1.2 P

|

800 MHz～2.5 GHz

d      2.3 P

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 maximum rated output power of the transmitter not listed in the above table, it is recommended that the isolation distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency column, where P is the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W).

1. Notice 1：At 80 MHz and 800 MHz frequency points, the formula of higher frequency range is used.
2. Notice 2 ： These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by absorption and reflection from buildings, objects and people.

Chapter 6 Equipment Maintenance

Clean the device
Clean the device with a soft and damp cloth, but to avoid liquid into the interior of the device.

Therapy handle cleaning and replacement

Clean the hand piece lens regularly (In the course of treatment will be a small amount of pigment granules splashed on the treatment lens, affecting the laser output), and wipe the lens with lens paper or cotton ball moistened with ethanol (Wipe the treatment lens after each use)
Each hand piece has a certain life with 1 million treatments. It must be replaced after a certain time, you need to contact the dealer to buy again.

Waste disposal of equipment
The waste of the equipment shall be treated harmlessly in accordance with the relevant regulations of local environmental protection.

System troubleshooting

Table 5-3-1 System troubleshooting

Check circuit breakers, fuses. The specification of the fuse is 250V/16A, just open the fuse box to replace the fuse.
Check the power switch
Please contact your dealer
Power button no response| Please contact your dealer
---|---
System can not initialize| Check the power
| Please contact your dealer
The output of the laser energy is weak or empty gun – no laser| Voltage is too low, the treatment head does not work
Check whether the laser mirrors dirt or not, please wipe clean up if has
Internal handle damaged, replace treatment head.
Remove the treatment head, check the front-end mirror damage or not
Treatment head is overheated, closed the device,cooling a half hours
Check whether the handle or treatment head leaks
Laser treatment head naked| Check whether the laser treatment head is damaged, if damaged to replace a new one.
Treatment process, click the trigger button, appear a “creak” sound| Equipment unused for a long time, triggering difficulties.
Water temperature alarm, check whether the water temperature is

normal.

Water flow alarm, check whether the water flow is normal.
Water level alarm, check whether the water level is normal.
The xenon lamp is damaged, replace the lamp.

Cooling system temperature too high

| Close the system , let the system cooling for a period ,then restart .If still not OK, please contact the dealer.
Treatment handle energy is too low| Check whether there are impurities on the lens surface, if any, wipe it

clean

Check whether the treatment handle overheating , if any, shut off and cooling half an hour then used again
| Check whether the front mirror is complete , if damaged , please contact the dealer
---|---

Chapter 7 Specifications

This chapter describes the most important technical parameters and system categories of treatment system.

Table 7-1 System Specification

210-240VAC         10A(refer to system tag)
Circuit Frequency:| 50/60Hz
System Category|
The Type Of Electric Shock:| A kind of equipment
The Degree Of Electric Shock:| B type device
The Degree Of Harmful Water Intrusion

Protection：

| General equipment
Climatic Conditions(During

Operation)

|
Ambient Temperature| +15℃ to +30℃
Relative Humidity| 30％ – 80％
Atmospheric Pressure| 86.0kpa – 106.0kpa
Climatic Conditions (During

Transport Storage )

|
Ambient Temperature| -20°C – +60°C;
Relative Humidity| ≤ 93 %, no condensation
---|---
Atmospheric Pressure| 86.0kpa – 106.0kpa

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