INIA SKB 2118 IPL Cooling Hair Removal Device Instruction Manual

INIA SKB 2118 IPL Cooling Hair Removal Device

Thank you

Do not apply any skincare products before use! Please follow the instructions in the “Instruction Manual” for product installation and usage.

This product is intended for use in a home care environment, regardless of whether it is used by inexperienced operators or trained medical personnel.

Thank you for purchasing this product. To facilitate its use, please read and keep this instruction manual before use. The images in this manual are for illustration purposes only, and the actual product may vary.

Cautions, Warnings, and Tips

Dear user: Greetings! Thank you for choosing our product. To better understand this user manual and use the product, and to prevent personal injuries and property damage, please read and follow the instructions provided below carefully.

   If the product is damaged, please stop using it immediately and avoid touching any internal parts to prevent electric shock.
 Do not insert any objects into this product, and please do not place it casually.
 Please do not use non-original adapters with this product.
 Do not use the product while bathing or showering.
 Deferent parts of the product require deterrent light intensity settings due to varying skin tones.
 Please refrain from using this product on the following areas of the body or in the presence of the following conditions: nipples, genitals, major arteries, inner navel, areas with plastic surgery, larynx, eyeballs/eyelids/around the eyes, or around the anus. (Please note that this list is not exhaustive. If you are unsure whether you can use this product, it is strongly recommended that you consult with a doctor.)
 Regularly check and clean the emission port to prevent burns and malfunctions during use.
 Do not place the emission port close to objects that are easily demagnetized, to avoid malfunction and damage.
 Do not direct the emission port towards black objects to prevent malfunction of the machine.
 Avoid using in the presence of children, as the hair remover emits a strong light that could harm the eyes.
 Do not touch the light emission port aver use, as it generates high temperatures and can cause burns.
 Within 24 hours after irradiation, avoid exposing the irradiated parts to direct sunlight.
 If the skin on the irradiation area is not dry and clean, it will affect the use effect of pulsed light, and it may also cause the product to not flash or flash unexpectedly.
 Avoid using the product around the eyes to prevent eye injuries. While protective goggles can protect users during normal operation, they may not completely block the energy when operating at a close distance to the eyes, which can be absorbed by the iris melanin. Please wear protective goggles before use. Although the light does not directly affect the eyes, the high- frequency flashing light may impact your vision.
 If your hair is longer than 1mm, it is recommended to use a shaver to remove the hair first. Long hair absorbing heat on the skin surface can cause redness and swelling, and burnt hair may splatter onto the light exit, producing odor, which can affect your user experience.
 If the skin in the depilation area is not dry or clean, it may affect the effectiveness of the treatment and lead to improper or accidental light emission.
 Do not use the product near water-filled bathtubs, showers, washbasins, or other containers.
 Keep the device in a well-ventilated and dry environment, away from children.
 Individuals with physical disabilities, mental disorders, or lack of relevant experience and knowledge must use, clean, and maintain the product under the supervision and guidance of a guardian.
 After using the device to treat the armpits, do not immediately apply antiperspirant.
Regularly clean any foreign objects or dirt from the light exit to avoid product malfunctions and damage to the light exit.
 Do not use the product when the ventilation ports are blocked to prevent product malfunctions and fire hazards.
 Avoid shining the light on clothes, hair, and other objects to prevent scorching, discoloration, and damage. Do not use the product on pets to avoid causing harm.
 Before and after use, clean the device from any attached hair and skincare products to avoid product malfunctions and skin damage during subsequent use.
 Keep the product and power adapter dry.
 Set the energy intensity according to your skin condition. For first-time use, always start with the lowest setting.
 If your skin feels slightly warm or reddened after use, it is a normal reaction.
 You can use the cooling function to alleviate any discomfort.
 When performing back hair removal, it is recommended to seek assistance from someone else. Operating alone may pose risks.
The device should not be left unattended after turning it on. Please remember to turn it off after use.
 Clean the skin to ensure there are no residual hair, completely dry, and free from oily substances.
 When there is a temperature difference of more than 2°C in the environment (transitioning from a cold environment to a hot one or vice versa), turn off the device and let it rest for about 2 hours before use.
 Do not use the product near flammable or explosive materials (including sprayers, gas stations, etc.) as it may cause fire or electric shock hazards.
 The recommended operating temperature for this hair removal device is between 5°C and 30°C. Please ensure the room temperature before use.
 Within 48 hours offer hair removal, avoid direct exposure of the treated areas to ultraviolet rays. Apply sunscreen when going outdoors.
 Do not direct the light exit towards black objects to avoid damage to the black objects and the device.
 Do not expose the product to sunlight or keep it under UV lamps for an extended period as it can severely damage the product.
 If the built-in fan does not run (no humming sound) after turning on the power, do not use the device to prevent product malfunctions.
 This device can only be used with the supplied power adapter.
 If the power cord is damaged, to avoid any risks, it must be replaced by professionals from the manufacturer, their repair department, or similar services.
 Before connecting the device, please check if the voltage on the device matches the local mains voltage to avoid the risk of electric shock or permanent damage to the device.
 If the wall socket connection for powering the device is poor, the device’s plug may become hot. Make sure to connect the device to a properly installed wall socket to avoid the risk of fire and burns.
 Do not subject the device to severe impacts to prevent damage to the lamp.
 The fuse and other components of this product are not removable as they are located inside the product.
 There are no replaceable parts.
 The maintenance personnel for this product are only internal staff of the company. Therefore, circuit diagrams and component lists are not provided externally and are for internal reference only.
 The light exit is the application part of this product. Place the light exit on the skin area to be treated, press it gently against the skin vertically, and the product will emit light.
**Use the device in a brightly lit environment as much as possible to reduce the pupil aperture and allow less light to enter the eyes.
 When using the intense pulsed light therapy device, always wear protective goggles as required by the operating instructions.
 The patient is the intended operator.
  Warning: Modification of this device is not permitted.
  Disclaimer:** This device is intended to be connected to an independent power adapter. The adapter is part of this device.
 If it is the first time using this product or if you have recently tanned, perform a skin test on each area to be treated. To perform a skin test: Select an area near the treatment area (do not attempt to use the product on difficult or sensitive areas such as ankles or bony areas). According to your skin color type, make sure to set the device to the lowest setting. Place the device vertically on the skin, ensuring close contact between the light exit and the skin. After the indicator light blinks, press the light emission button to emit a flash, then slide the device to the next area to be treated. Gradually increase the settings, emit light once, and then move the device to the next area. After the skin test, wait for 2 hours to assess the skin condition. If there are no abnormalities (redness, blisters) in the treated area, you can proceed with the treatment.

Note: When using the hair removal device, it is possible to touch the illustrated body air outlet for 1-10 seconds. Please avoid contact. The highlighted air outlet is the cooling part of this product. Blocking the air outlet may cause poor heat dissipation, and higher temperatures can lead to skin discomfort.

Contraindications

 Pregnant women, breastfeeding women, women during menstruation, individuals with scars, diabetes, fragile skin, and photosensitive skin should not use this product.
 Severe heart disease, severe hypertension, malignant tumors, folliculitis, infectious skin diseases, burn wounds, and individuals with coagulation disorders are prohibited from using this product.
 Do not use if you have collagen metabolism disorders, including scars and poor wound healing.
 People with vascular diseases such as varicose veins, dilated blood vessels in the treated area, should not use this product.
 Do not use if the skin is photosensitive and prone to rashes or allergies.
 Do not use on areas with infections, herpes simplex, skin lesions, hematomas, etc.
 Do not use if you have immune response disorders (including HIV/AIDS infection, lupus, etc.).
 Prohibited for patients with any bleeding disorders and those using topical retinoic acid, alpha hydroxy acid(AHA), beta hydroxy acid (BHA), or salicylic acid.
 Caution is advised for individuals who have undergone chemical hair removal within 30 days, used whitening products in the short term, or used cosmetics containing vitamin A.
 Do not use concurrently with essential oil products. Ensure that the skin in the treated area is clean and dry, and do not apply creams, lubricants, or other cosmetics. If the skin surface is not clean or dry, it may affect the product’s efficacy or even damage the product.
 Prohibited to use aspirin, immunosuppressants, retinoic acid, and other drugs. Recent use of  photosensitive drugs (such as tetracycline, sulfonamides, etc.) is not recommended.
 For sunburned skin, wait until the skin is repaired before using the product.
 Do not apply on sensitive areas such as mucous membranes.
 Prohibited for use on any unhealed wounds. Not recommended for hirsutism or other hirsutism conditions.
 If taking analgesics, it may reduce the skin’s sensitivity to heat. Caution is advised before the analgesic effect subsides.
 Do not use this product if it is not suitable for your skin tone or hair color.
 Do not use on the nipples, genitals, major arteries, inner navel, or around the anus. Use on these areas may cause skin swelling, blisters, temporary skin discoloration, and skin whitening.
 Prohibited for use on tattooed skin, black/brown spots, or black-colored blemishes (such as dark freckles, birthmarks, moles, or warts) on the depilated area. Tattoos or dark spots may absorb excessive light energy, resulting in skin swelling, temporary or permanent blisters, skin discoloration, or whitening. (Consult a doctor before use if necessary).

Intended Use and Scope of Application

1. Intended Use: This device is intended to assist in reducing body hair and improving skin appearance.
2. Intended Usage Environment: For indoor use only.
   • Ambient Temperature: 0°C – 30°C
   • Ambient Humidity: 10% – 90%
   • Atmospheric Pressure: 86.0 kPa – 106.0 kPa
   • Power Supply Voltage: Power Input: 100-240V~ 50/60Hz, Power Output: DC12V 4A
3. Applicable Users: Only suitable for individuals over 18 years old, and skin/hair types must meet the following criteria:

Skin and Hair Usage Criteria:

Skin Tone Chart| | | | | |
---|---|---|---|---|---|---

Hair
Color Chart| Fair| Light| Light Brown| Tan| Dark Brown| Dark

White| X| X| X| X| X| X

Auburn| X| X| X| X| X| X

Light Blonde| X| X| X| X| X| X

Light Brown| 4/5| 4/5| 4/5| 1/2/3| X| X

Chestnut| 4/5| 4/5| 4/5| 1/2/3| X| X

Dark Brown| 4/5| 4/5| 4/5| 1/2/3| X| X

Black| 4/5| 4/5| 4/5| 1/2/3| X| X

(Note: indicates not applicable)

Note:

• To confirm if your skin type is suitable for using this device, please refer to the skin tone comparison card.
• Due to various factors, your skin may react differently under different exposure times or circumstances. Always adjust the frequency and intensity of device usage based on the actual condition of your skin.

Product Structure

Note: The function is only applicable to the MOOD Pro (model SKB-2118P).

Main Product Performance Parameters

1. Normal Operating Conditions
   a. Ambient Temperature: 0°C ~ 30°C
   b. Relative Humidity: 10% ~ 90%
   c. Atmospheric Pressure: 86.0 kPa ~ 106.0 kPa
   d. Power Specifications: DC12V 4A
   e. Software Release Version: V1.0
   f. Product Storage Conditions: -10°C ~ 55°C

2. Key Performance Parameters:
   a. Output Wavelength Range: 550nm ~ 1100nm
   b. Pulse Output Mode: Single Pulse
   c. Spot Size: 3 square centimeters, with an energy output of 3.2~5.5J per square centimeter at the highest level.
   d. Single Cooling Temperature ≤17°C (measured at room temperature of 25°C)
   e. The device will automatically power o¤ if there is no button operation or contact with the skin for 5 minutes. Power-on Cooling Temperature ≤17°C (measured at room temperature of 25°C)

3. Other Parameters
   a. Product Weight: 238g
   b. Waterproof Rating: IPX0 for the entire product (not waterproof)
   c. Dimensions: 167 x 61 x 39 mm

Product Installation and Use Instructions

1. Precautionary Check
   a. Unboxing Check: Take out the main unit and its accessories from the packaging box, count the accessories according to the packing list, and keep the related packaging materials for future transportation, storage, and reference purposes.
   b. Check if the main unit and accessories are intact, and inspect for any signs of mechanical damage. If there are any indications of equipment malfunction, do not use it and contact the dealer or afar-sales service immediately.

2. Preparations before Use
   a. Determine if your skin tone is suitable for this product using the skin color chart provided in the instruction manual.
   Note: If it is your first time using this product or if you have recently tanned, perform a skin test on each treatment area. To conduct a skin test, select a nearby area to the treatment site (avoid difficult or sensitive areas such as ankles or bony areas). Adjust the intensity level to 1 according to your skin tone, place the device vertically on the skin with the flash window in close contact, wait for the indicator light to flash, and then press the Flash Button/Mode Switch Button to emit a flash. Move the device to the next treatment area, gradually increasing the intensity level and emitting a flash each time. After the skin test, wait for 2 hours to assess the condition of your skin. If there are no abnormalities such as redness or blisters, you can safely use the product.
   b. Use a shaver to remove and clean the hair from the treatment area, ensuring that the skin is in good condition, dry, and free from any wounds or abnormalities.
   Note: Before hair removal, clean the armpits from deodorant, perfume, creams, and other cosmetics, and ensure that the skin is in good condition and dry.
   c. Check the flash window for any hair residue or dirt. If necessary, clean the flash window according to the cleaning method provided in the user manual before using it.
   Note: If the flash window on the treatment head cannot be cleaned properly, it is recommended to replace the treatment head.

3. Instructions

4. Use steps
   a. Connect the power supply and keep a distance of at least 20-30 cm between the device and the eyes when using the intense pulsed light therapy device. Users should wear protective goggles.
   b. Press and hold the Power Button/Level Switch Button for 1.5 seconds to power on/off. After pressing and holding for 1.5 seconds, power on. The device will enter the default Manual Mode (the Intensity Indicator will flash, and the Mode and Ice Cooling indicators will remain lit).
   c. Intensity selection: Without skin contact, short press the Power Button/Level Switch Button to adjust the flash energy intensity. There are 5 intensity levels that can be cycled through, with the adjustment sequence being 1-2-3-4-5-4-3-2-1.
   d. Place the device vertically on the desired hair removal area, ensuring full contact between the device head and the skin. At this point, the Intensity Indicator will change from flashing to steady. Finger switch method by pressing the flash button briefly to emit light and begin the hair removal process.
   e. Offer use, press and hold the Power Button/Level Switch Button for 1.5 seconds to power o¤, or short press the Flash Button/Mode Switch Button to select another mode for further treatment.
   Note: If the device head is not fully in contact with the skin, the Intensity Indicator will continue flashing. If there is no button operation or the light output window does not touch the skin for 5 minutes, the device will automatically shut down.

5. Post-Hair Removal Precautions
   a. It is recommended to avoid contact with water within 6 hours after hair removal. After 6 hours, moisturize the treated area with hydrating lotion.
   b. Avoid using perfume, face masks, and cosmetics with exfoliating beads on the treated skin.
   c. If any discomfort occurs, please consult a dermatologist promptly.
   d. Sunbathing can cause darkening or sunburn of the skin, and using the device during this time may result in redness, swelling, or inflammation.
   Therefore, avoid excessive sun exposure during product use, and the time required for sunburn recovery should not be less than 1 week.
   e. Avoid swimming within 24 hours after hair removal and protect the treated area from excessive sun exposure. If unavoidable, be sure to apply sunscreen.
   f. Do not attempt to achieve skin tanning during hair removal treatments.
   g. Consult a doctor if you plan to undergo any plastic surgery procedures in the treated area after hair removal.

6. Treatment Intervals
   a. Weeks 1-4: 3 times per week
   b. Weeks 5-8: 2 times per week
   c. Over 8 weeks: Once every two weeks/month
   Weeks 1-4 3 times per week Slow down hair growth, reducing it by over 75%.

Weeks 5-8 2 times per week Hair becomes finer and sparser, maintaining smooth skin.

Over 8 weeks Once every two weeks /month Long-lasting results, bidding farewell to repeated hair removal.

Note: Perform multiple treatments based on hair growth conditions. For severe hair growth, adjust the intensity and frequency accordingly. Specific circumstances may vary from person to person.

4. Skin Sensing Display Instructions  

a. When the flash window makes contact with the skin, the Intensity Indicator remains steady, indicating that the device is ready for treatment.
b. When the flash window does not make contact with the skin, the Intensity Indicator will flash.

Product Maintenance and Care Methods

1. Machine Maintenance
   a. To ensure optimal performance and longevity of the product, please clean the device before and after each use to avoid the accumulation of hair residue and dust. Failure to clean the device properly may result in reduced effectiveness.
   b. Check the device, especially the transparent window and body components, to ensure they are clean and in good condition.
   c. Do not clean the device and its accessories under running water or in a dishwasher.
   d. Avoid using steel wool, abrasive cleaners (such as toothpaste), or corrosive liquids (such as gasoline, engine oil, acetone) to clean the product.
   e. Keep the device for intense pulsed light therapy dry. Do not immerse the device or any of its components in water to avoid the risk of electric shock.
   f. To prevent damage or loss of the device and its accessories, store them in the packaging box after each use. Prior to storage, make sure to clean the product thoroughly.
   g. If the product is not in use for an extended period, store it in a dry, shaded, and cool place, away from contact with hard objects to avoid damage.
   h. Avoid storing the product and its accessories in a humid environment for a prolonged period, as it may adversely affect the performance of the product.
   i. Regularly inspect the device, including the wires, for any signs of visible damage. In case of damage or breakage, discontinue using the device and unplug it from the socket when not in use to avoid the risk of entanglement.
   Note: If it is no longer possible to clean the transparent window, please stop using the product.

2. Cleaning and Disinfection
   Turn o¤ the machine and unplug it from the power source to allow it to cool down. The flash window of the device may become hot during use.
   Ensure it has cooled down before cleaning/disinfecting.
   Cleaning: Use a cloth dampened with water or a mild detergent to thoroughly wipe the device surface, then use a dry, so¨ cloth to dry it.
   Disinfection: Use a lint-free cotton pad dipped in 70%~75% medical alcohol to wipe the device surface for disinfection, then use a dry, so¨ cloth to dry it.
   Note: Take extra care when wiping during cleaning or disinfection to ensure that no moisture enters the internal components of the device.

3. Troubleshooting
   The following are common issues that may arise during the use of the device. If the provided information does not resolve your issue, please contact INIA’s customer service for assistance.
   

before using it again, ensuring the device head is in close contact with the skin until the indicator light turns on.
Indicator light not turning on| Poor device contact| Check if the power connection is normal. If it is, consider repair or replacement of the product.
Unusual odor during flashing| Contamination of the filter and presence of hair residue on the device body| Clean the filter and remove hair residue, reducing the intensity of light exposure.
Intense pain during hair removal| Hair not shaved before treatment| Shave the hair in the treatment area before using the device. If shaving causes skin irritation, trim the hair as short as possible and use the device in a comfortable setting.
The treatment area is not suitable for hair removal| Do not use this device on the labia, vagina, anus, nipples, or areola. It is also not suitable for use on men’s faces or scrotum.
High intensity of light exposure| Reduce the intensity of light exposure to a comfortable level.
Damaged light transmission window| Repair or replace the product immediately.
Redness in treated area after use| Mild redness is normal, harmless to the body, and will quickly fade| After hair removal, soothe the skin with aloe verge.
Unsatisfactory hair removal results| Low intensity of light exposure| Choose a higher intensity level for the next session.
Missing flash zones in the treatment area| Flash the device in areas that are close to each other, ensuring some overlap between flash zones.
Inability of the device to remove certain hair colors| This device is not suitable for removing light blonde, gray, red, or white hair.
Insufficient frequency of device usage| To successfully remove hair, it is recommended to follow the recommended irradiation plan.
Slower response to light exposure| Continuously use the device for at least 6 months, as it can still inhibit hair regrowth during this period.
Device casing becomes warm during use| Normal phenomenon| No action required. If the device has been used for a long time, you can turn it off, let it rest, and cool down before using it again.

Storage/Transportation Conditions and Methods

1. Please place the product in a dry, well-ventilated, dust-free, and pollution-free area, away from direct sunlight. The storage and transportation environment should meet the requirements.
   • Storage temperature: -10°C ~ 55°C;
   • Humidity: 10% ~ 90%;
   • Atmospheric pressure: 86.0 kPa ~ 106.0 kPa.
2. Regularly inspect the product for any safety hazards to ensure safe usage.

Main Safety Features

1. Classified by type of protection against electric shock: Class II;
2. Classified by degree of protection against electric shock: Type BF applied part;
3. Classified by degree of protection against ingress of liquids: IPX0;
4. Classified by safety in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide: Non-AP/APG type;
5. Classified by operating mode: Continuous operation;
6. Rated voltage of the device: 100-240VAC;
7. Input power of the device: 12.0V, 4.0A;
8. Whether the device has protection against defibrillation discharge effects in the applied part: Not applicable;
9. Whether the device has signal output or input parts: Not applicable;
10. Permanent installation equipment or non-permanent installation equipment: Non-permanent installation equipment;
11. Electromagnetic compatibility GB 4824 grouping: Group 1, Class B.

Use Limit and Parts List

1. Product Usage Period: 2 years, Lamp Usage Life: 300,000 exposures
2. Product Accessories List:
   No.| Accessor Name| Quantity
   ---|---|---
   1| Adapter| 1
   2| User Manual| 1
   3| Goggles| 1

Explanation of Graphics, Symbols, Abbreviations, etc. used in Medical

Device Labels

Waste Disposal Statement

As this product is classified as a medical electronic device, it should not be treated as general household waste when its usage life is over. It should be disposed of according to the regulations and guidelines applicable in the respective region.

Warranty

The warranty period for this product may vary depending on the country of sale. We will strive to extend the warranty period to the maximum extent permitted by the laws of that country. If the instrument experiences quality issues within the warranty period, we will provide free repair or replacement. However, damages caused by improper use or non-compliant operations are not covered under warranty. In such cases, we will replace the damaged parts or offer a trade-in at cost price. The ownership of the old instrument belongs to our company.

Please present your order purchase receipt and our official website’s after- sales registration information when requesting warranty service. The warranty period for our products starts from the date of receipt of the order at the time of purchase.

Our company may not offer warranty or return services under the following conditions:

1. Product damage caused by unforeseeable events such as fire, earthquake, flood, etc.
2. Instrument malfunctions and damages caused by your negligence, misuse, or other abnormal conditions during use.
3. Instrument damage caused by unauthorized disassembly or improper storage (e.g., rodent infestation, liquid ingress).
4. Damage caused by the forced use of the product in non-product usage environments, including but not limited to exceeding workloads. Equipment damage caused by abnormal external forces (falling, compression, collision, etc.).
5. Equipment damage caused by the use of non-manufacturer accessories and expansion components.
6. Product damage caused by other uncontrollable circumstances
7. Our company shall not be liable for consequential damages or losses arising from the use or operation of this product, including but not limited to loss of business profits, business interruption, other losses caused by using the instrument, costs associated with replacing equipment, devices, or services, or customer claims.
   Our company will assume the types and extent of liability for unexpected events in accordance with relevant laws and regulations.
   All rights of final interpretation belong to X6 Technology LLC.

Electromagnetic Compatibility

Note: The intense pulsed light therapy device complies with the requirements of the YY0505 standard for electromagnetic compatibility.
Users should install and use the device based on the electromagnetic compatibility information provided in the accompanying
documentation
Portable and mobile RF communication devices may affect the performance of the intense pulsed light therapy device. Please avoid strong electromagnetic interference, such as proximity to mobile phones, microwave ovens, etc., while using the device. Refer to Annex 1 for the guide and manufacturer’s statement.

Warning: The intense pulsed light therapy device should not be placed near or stacked with other products. If it is necessary to place it near or stack it with other products, ensure that it operates normally in the configured setup.
In addition, the manufacturer of the intense pulsed light therapy device recommends using the power adapter sold as an internal component. Using accessories and power adapters that are not specified may increase the emissions or reduce the immunity of this product.

Appendix 1

Guidance and Manufacturer’s Declaration – Electromagnetic Emission

This high-intensity pulsed light therapy device is intended for use in the electro- magnetic environment specified below. The purchaser or user of this device should ensure that it is used in such an electromagnetic environment:
Emission Test| Compliance| Electromagnetic Environment  Guidance
GB 4824 RF Emission| Group 1| This high-intensity pulsed light therapy device uses radio frequency (RF) energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference with nearby electronic devices.
GB 4824 RF Emission| Class B| This high-intensity pulsed light therapy device is suitable for use in all establishments, including domestic environments and those directly connected to the public low-voltage power supply.
GB 17625.1 Harmonic Emission| Class A
GB 17625.2 Voltage Fluctuation /Flicker Emission| Compliant

Appendix 2

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

This high-intensity pulsed light therapy device is intended for use in the electromagnetic environment specified below. The purchaser or user of this device should ensure that it is used in such an electromagnetic environment:
Immunity Test| IEC 60601 Test Levels| Compliance Criteria| Electromagnetic Environment – Guidance
Electrostatic Discharge (ESD) GB/T 17626.2| ±6 kV contact discharge ±8 kV air discharge| ±6 kV contact discharge ±8 kV air discharge| The floor should be wood, concrete, or ceramic tile. If the floor is covered with synthetic material, the relative humidity should be at least 30%.
Electrical Fast Transient /Burst GB/T 17626.4| ±2 kV on power supply lines ±1 kV on input /output lines| ±2 kV on power supply lines| The power supply should have the quality typically found in a commercial or hospital environment.
Surge GB/T 17626.5| ±1 kV differential mode voltage ±2 kV common mode voltage| ±1 kV differential mode voltage ±2 kV common mode voltage| The power supply should have the quality typically found in a commercial or hospital environment.
---|---|---|---
Voltage Dips, Short Interrup- tions, and Voltage Variations on Power Supply Input Lines GB/T 17626.11| <5 % UT, duration 0.5 week (on UT, >95% dip) 40 % UT, duration 5 weeks (on UT, 60% dip) 70 % UT, duration 25 weeks (on UT, 30% dip) <5 % UT, duration 5 s (on UT, >95% dip)| <5 % UT, duration 0.5 week (on UT, >95% dip) 40 % UT, duration 5 weeks (on UT, 60% dip) 70 % UT, duration 25 weeks (on UT, 30% dip) <5 % UT, duration 5 s (on UT, >95% dip)| The power supply should have the quality typically found in a commercial or hospital environment. If continuous operation of the semiconductor laser therapy device is required by the user during a power interruption, it is recommended to use an uninterruptible power supply or battery power for the semiconductor laser therapy device.
Power Frequency Magnetic Field (50/60 Hz) GB/T 17626.8| 3A/m| 3A/m| The power frequency magnetic field should have the characteristics of the typical levels of power frequency magnetic fields in typical locations of a commercial or hospital environment.
Note: UT refers to the AC mains voltage prior to applying the test voltage.

Appendix 3

Guidelines and Manufacturer’s Declaration – Electromagnetic Immunity

This intense pulsed light therapy device is intended for use in the electromagnetic environment specified below. The purchaser or user should ensure that it is used in such an environment:
Immunity Test| IEC60601

Test Level

| Compliance Level| Electromagnetic Environment – Guidance
RF
Conducted GB/T 17625.6
RF
Radiated GB/T 17626.3| 3 Vrms
150 KHz –
80 MHz
3V/m
80 MHz – v
2.5 GHz| 3 Vrms
3V/m| Portable and mobile RF communication equipment should not be used closer than the recommended separation distance to any part of the (Infrared Forehead Thermometer, Model: HP-311), including cables. The distance should be calculated using the formula corresponding to the transmitter frequency. d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz
Where, P is the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W), and d is the recommended separation distance, in meters (m).
The field strength of a fixed RF transmitter is determined by surveying the electromagnetic field, and should be lower than the compliance level at each frequency range
Interference may occur near equipment marked with the following symbol.
Note 1: Use the formula for the higher frequency range at 80MHz and 800MHz.

Note 2: These guidelines may not be suitable for all situations, as electromagnetic propagation is affected by the absorption and reflection of buildings, objects, and the human body.

a The field strength of fixed transmitters, such as wireless (cellular/cordless) phones and base stations for land mobile radios, amateur radios, AM (Amplitude Modulation) and FM (Frequency Modulation) radio broadcasts, and television broadcasts, cannot be predicted theoretically. To evaluate the electromagnetic environment of a fixed RF transmitter, the electromagnetic field survey should be considered. If the field strength at the location of the (Infrared Forehead Thermometer, Model: HP-311) is found to be higher than the RF compliance level for the application described above, the (Infrared Forehead Thermometer, Model: HP-311) should be observed to verify that it is operating normally. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the (Infrared Forehead Thermometer, Model: HP-311).
b Across the entire frequency range of 150KHz to 80MHz, the field strength should be less than 3 V/m.

Appendix 4

Recommended Isolation Distance Between Portable and Mobile RF Communication Equipment and this Intense Pulsed Light Therapy Device

This Intense Pulsed Light Therapy Device is intended to be used in an electro- magnetic environment where radiation from RF communications equipment is controlled. Based on the maximum output power of the communication equipment, the purchaser or user can prevent electromagnetic interference by maintaining the minimum distance recommended below between portable and mobile RF communication equipment (transmitters) and this Intense Pulsed Light Therapy Device.
Rated Maximum Output Power of Transmitter /W| Isolation Distance /m for Different Frequencies of Transmitter
150 KHz~
80 MHz
d = 1 . 2√P| 80 MHz~

800 MHz d = 1 . 2√P

| 800 MHz~

2 . 5 GHz d = 1 .2√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 rated maximum output power of the transmitter not listed in the above table, the recommended isolation distance d, in meters (m), can be determined using the formula in the corresponding frequency column of the transmitter. Here, P is the maximum rated output power of the transmitter provided by the manufacturer in watts (W)
Note 1 : For frequencies of 80 MHz and 800 MHz, use the formula for the higher frequency range.
Note 2 : These guidelines may not apply to all situations as electromagnetic propagation is affected by the absorption and reflection of buildings, objects, and human bodies.

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