LED Neck Mask FAC02 - Beauty care device SILKN - Free user manual and instructions

USER MANUAL LED Neck Mask FAC02 SILKN

User-friendly Manual

Copyright 2024 © Silkn Beauty Ltd. All rights reserved. Legal notice Invention Works B.V. reserves the right to make changes to its products or specifications to improve performance, reliability, or manufacturability. Information furnished by Invention Works B.V. is believed to be accurate and reliable at the time of publication. However, Invention Works B.V. assumes no responsibility for its use. No license is granted by its implication or otherwise under any patent or patent rights of Invention Works B.V. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Invention Works B.V. Data is subject to change without notification. Silkn Beauty Ltd. has patents and pending patent applications, trademarks, copyrights, or other intellectual property rights covering subject matter in this document. The furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property rights except as expressly provided in any written agreement from Silkn Beauty Ltd. Specifications are subject to change without notice. Silk’n and the Silk’n logo are registered trademarks of Silkn Beauty Ltd. Manufactured for: Silkn Beauty Ltd. Alon Ha-Tavor 15, Caesarea, 3079516, Israel www.silkn.com, www.silkn.ca – [e-mail] Distributed by: Invention Works B.V. Galileïstraat 17, 3029 AL Rotterdam, The Netherlands www.silkn.com, www.silkn.ca – [e-mail] EN4

2.1 Reading and storing the user manual ______________ 6

10.2 Carrying out the treatment _____________________ 18

1 Package contents/device parts

Operation button ( )

2.1 Reading and storing the user manual

This user manual accompanies this LED Neck Mask (hereafter referred to as the “product”), and contains important information on setup and handling. Before using the product, read the user manual carefully. This particularly applies to the safety instructions. Failure to do so may result in personal injury or damage to the product. Store the user manual for further use. Make sure to include this user manual when passing the product on to third parties.

2.2 Explanation of symbols

The following symbols and signal words are used in this user manual, on the product or packaging. WARNING! This signal symbol/word designates a hazard with moderate risk, which may result in death or severe injury if not avoided. NOTICE! This signal word warns of possible damage to property. This signal symbol provides you with useful additional information on handling and use. Read the user manual before you start using the product.7

Compliant with CE’s EMC standard requirements. This symbol identifies devices classified as type BF. Devices marked with this symbol are only suitable for household use (dry indoor rooms). IP22 IP classification. Keep the product away from fire. Place the product upwards. Keep the product dry. 3 Product desciption

3.2 Product features

• Select the corresponding working modes and adjust the treatment times according to the skincare needs.

• Small, light and easy to carry.

3.3 Remote control markings

switches the LEDs on/o and controls the power to the product. It contains a rechargeable Lithium ion polymer battery.8

Marking Meaning M1 Red LED lights M2 Blue LED lights M3 Infrared lights M4 Mixed lights A Automatic operating mode M Manual operating mode 4 Safety

The product adopts the latest LED light therapy technology by combining 4 kinds of light therapy. A single device can solve various skin problems. The product is a home use wearable LED phototherapy device which can only be used in the instructed ways and cannot be used for other purposes. Otherwise, it may cause personal injury or damage to the product. The manufacturer and distributor are not liable for damage caused by improper or incorrect use. Do not use the product to make measurements of any sort, or to draw any conclusions regarding indication to the treatment. The product does not require checking on the light output as the LEDs do not dim with age to any practical extent.

4.2 Intended use of the 4 LED lights

Red light Treatment of full-face wrinkles. Blue light Treatment of mild to moderate inflammatory acne. Infrared light Provide topical heating for the purpose of elevating tissue temperature; relieving arthritis, muscle spasm and stiness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed lights Treatment of mild to moderate inflammatory acne.9

The product is an electrical device, which under certain circumstances could present an electrical shock hazard to the user. Read the user manual thoroughly and follow the instructions to assure maximum safety during operation. The intended operators or users must be in good health to use the product.

4.4 Contraindications

• Do not use the product to treat any other conditions apart from those listed in the intended use of the LED lights. The product has not been tested for any other conditions than those listed, and the risk is unknown.

• Do not use the product if you are pregnant, planning on becoming pregnant or breastfeeding. The product has NOT been tested on pregnant or breastfeeding women and therefore the risk to the foetus, neonate or pregnant women is unknown.

• Do not use the product if you suer from Lupus erythematosus, photosensitive eczema or Albinism. Otherwise, you may have a severe skin reaction.

• Do not use the product if you suer from any photosensitive disorder (sensitization to light). Otherwise, you may have a severe skin reaction.

• Do not use the product if you are taking any medication that can cause photosensitivity. Otherwise, you may have a severe skin reaction. Photosensitivity is a common side eect of various medications. These can10

include certain antibiotics, chemotherapy drugs, and diuretics. If you are unsure about any medication you may be taking, consult your healthcare provider.

• People with wounds should not use the product or avoid using the product on the wounds.

• The patient is the intented operator of this product. The patient can safely use the skin care functions. The patient should not perform maintenance while the product is in use, including charging the battery.

• The mask of the product is the applied part.

• Before using the product, you must carry out a sensitization test. Do not use the product if you are sensitive to the product.

• Do not use the product in any way that is not exactly as specified in this user manual. Use of the product other than exactly as specified in this user manual has not been tested and the risk is unknown.

• TURN OFF and REMOVE the product immediately if it feels hot or your skin feels uncomfortably warm.

• Do not use the product without removing creams, lotions or make-up before treatment. Some ingredients in these products may cause light sensitization or11

may reduce the eect of the treatment. If you use the product without removing these products, it may cause a skin reaction, or reduce the eect of the treatment.

• Never use the product near water or where water can be spilt onto the product.

• Do not use the product if you think it has come into contact with water.

• Keep the product away from hot surfaces.

• Do not attempt to modify the product in any way. Modifying the product will void your warranty. Modifying the product could cause an electric shock when the system is used again. The product contains no serviceable parts.

• Do not use the product if any part of the product, charging plug or cable is damaged in any way.

• Do not use the product during charging.

• Do not touch the product, USB cable and USB wall adapter with wet hands during charging.

• Do not store flammable and explosive materials (sprayers, oil, gas, etc.) near the product.

• Do not use this product in a bath, bathroom, swimming pool, etc. where it can be directly exposed to water or liquids.12

• Do not use heaters in the vicinity of the product.

• Do not use the product close to or stacked with other equipment. If such use is necessary, the product should be observed to verify that it can operate normally under the configuration used.

• Do not place the product within the reach of pets and children to avoid abuse of the product or causing damage to the product.

• Do not expose the product to the outdoors for a long time to avoid contamination of the product by pests.

• Do not excessively bend or squeeze the product and power cord with heavy objects.

• Do not modify or replace the power cord and battery by yourself.

• Do not look directly at the light sources of the product.

• Do not expose the product to harmful optical radiation.

• Do not play with cables to avoid strangulation.

• Avoid inhalation or ingestion of small parts.

• Persons with potential allergies to the accessible materials used in the product should not use the product.13

• Do not touch the product with wet hands when the product is in use to avoid injury.

• Do not use accessories, removable parts and materials not described in the user manual.

• Do not interconnect the product with other devices not described in the user manual.

• It is recommended to wear protective goggles that protect wavelength range of 200–2,000 nm when using the product.

• Do not use the product on the face without wearing protective goggles.

• Except for the connecting wires and charging wires sold by the manufacturer as spare parts of internal components, the use of accessories and cables outside the regulations may result in an increase in the emission of the product.

• The purchaser or user must install and use the product according to the information provided in the user manual.

• The product is a personal item and it is not recommended to share it with others.

• The product’s straps contain a mixture of polyester and nylon. If you are allergic to any of these materials, you may not be able to use the straps provided.14

• The expected operator or user must be trained in relevant skills and knowledge.

• The electric shock protection level of the remote control is Class II, and the electric shock protection level of the mask belongs to the discharge of internal power supply of the medical device.

• Provide the operator or responsible organization with warnings regarding any significant risks of reciprocal interference posed by the presence of the product during specific investigations or treatments.

• If the product is intended for connection to a separate power supply, either the power supply shall be specified as part of the device or the combination shall be specified as a system.

• Users and patients/clients should pay attention to eye and skin protection and should not look directly at the light when using the product.

• The light therapy skin care function is safe for the patients to use.

• Patients should not perform maintenance on their own, including changing batteries.

• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.15

5 Checking the product and package contents NOTICE! RISK OF DAMAGE!

• If you are not cautious when opening the packaging with a sharp knife or other pointed objects, you may quickly damage the product. Be very careful when opening it.

1. Take the product out of the packaging.

2. Check to make sure that all parts are included (see Fig. A).

3. Check whether the product or individual parts are damaged. If

this is the case, do not use the product. Contact our customer service. 6 Operating modes Modes of operation: Continuous operation recommended. This product has 4 operating modes: red light, blue light, infrared light and mixed lights.

1. Red light mode: wavelength 620 nm.

2. Blue light mode: wavelength 460 nm.

3. Infrared light mode: wavelength 850 nm.

4. Mixed light mode: wavelength 620 nm, 850 nm and 460 nm.

7 Charging WARNING! RISK OF INJURY!

• Warning: Use of this product adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the16

product and the other equipment should be observed to verify that they are operating normally.

• Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this product could result in increased electronmagnetic emissions or decreased electronmagnetic immunity of this product and result in improper operation.

• Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12inches) to any part of the ME equipment, including cables specified by the manufacturer. Otherwise, this could result in the degradation of the performance of this product.

• Fully charge the product before first use and when the battery power is low.

• Only use the original USB cable and USB wall adapter for charging.

• When the battery power is low, the indicator lights on the remote control flash 5 times before switching o automatically. Recharge the product.

• The product cannot be used during charging.

• If the product is to be stored for an extended period, the battery level should be checked and the product should be charged regularly.

• Type of battery: Li-ion.

of the remote control

(see step 1 in Fig. B).17

2. Plug the smaller end of the USB cable

into the charging port

of the remote control (see step 2 in Fig. B).

3. Plug the larger end of the USB cable into the USB port of the

. Make sure the voltage marked on the adapter matches the voltage of the power outlet.

4. Plug the USB wall adapter into a power outlet for charging.

Charging starts automatically. Check the program indicator lights

for the charging progress: One indicator light = 25 % charged Two indicator lights = 50 % charged Three indicator lights = 75 % charged Four indicator lights = fully charged

5. When charging is done, unplug the USB wall adapter from the

power outlet and disconnect the USB cable from the charging port of the remote control. 8 Assembly Follow the illustrations to assemble the elastic straps (see Fig. C).

1. Open the hook-and-loop fasteners on the elastic straps

and guide the elastic straps through the side openings of the neck mask

2. Close the hook-and-loop fasteners to secure the elastic straps

on the neck mask. 9 Sensitization test Before carrying out your first treatment you must carry out a sensitization test. Follow the steps below:

1. Place the product over your inner arm.

2. Switch ON the product and allow the product to run for its

full 10-minute treatment program.

3. At any time if your skin feels hot or uncomfortable, stop using

the product immediately.

4. After the treatment, wait at least 6 hours. If the skin on your

inner arm appears red and/or itchy, then the product is not suitable for you. Return the product to the retailer within 14days of purchase.18

• If you use the product in manual mode, the treatment should be controlled within 15 minutes. If the product is used for too long, it may cause damage to the skin.

• If you are using the product for the first time, refer to the following treatment plan and adjust it according to your skin conditions. Use the product 3–4 times a week for the first 2–3weeks. Reduce to 1–2 treatments a week once results show.

10.1 Treatment recommendations

• For the best results use the product for 10 minutes in manual mode or 15 minutes in automatic mode per treatment.

• Use the product 3 to 4 times a week for the first 2–3 weeks. Reduce to 1–2 treatments a week once results show.

10.2 Carrying out the treatment

1. Assemble your mask as described in the chapter “Assembly”.

2. Clean and thoroughly dry your neck and hands.

3. Adjust the elastic straps

on the mask to ensure the mask fits comfortably.

4. Sit or lie down and place the mask over your neck.

to select the treatment.

6. Apply your preferred skincare serums or creams after treat-

ment as absorption is enhanced following the light therapy.

7. Continue with your skin care routine: 10–15 minutes for

each treatment with 3–4 treatments a week, reduce to 1–2 treatments a week once the results show.

10.3 Using the remote control

The product has 2 modes: manual mode and automatic mode. Manual mode

• Press and hold the operation button ( )

for 1 second to turn the product on. Upon turning on, the product defaults to manual mode with the red LED lights activated.

• If no buttons are pressed and after the manual mode indicator light

flashes 5 times, the product starts its timer. The product automatically switches o after 10minutes.19

once after turning the product on.

• Without any further action, the auto mode indicator light

flashes 5 times. The product then begins its automated timing sequence: red LED light for 5 minutes, blue LED light for 3minutes, infrared light for 4 minutes, and mixed lights for 3minutes.

• The product automatically switches o once the sequence completes. Alternatively, you can also press and hold the operation button ( ) for 3 seconds to switch o the product during use.

10.4 Light selection in manual mode

• Press the operation button ( )

for 1 second to turn on the product. The red LED light activates, and its corresponding program indicator light

• To turn o the product, either press and hold the operation button ( ) for 3 seconds or press the operation button ( ) 4 times. Blue LED light

• Press the operation button ( ) a second time. The blue LED light activates, and its corresponding program indicator light illuminates.

• To turn o the product, either press and hold the operation button ( ) for 3 seconds or press the operation button ( ) 3 times. Infrared light

• Press the operation button ( ) a third time. The Infrared light activates, and its corresponding program indicator light illuminates.

• To turn o the product, either press and hold the operation button ( ) for 3 seconds or press the operation button ( ) twice. Mixed lights

• Press the operation button ( ) a fourth time. The mixed lights activate, and its corresponding program indicator light illuminates.

• To turn o the product, either press and hold the operation button ( ) for 3 seconds or press the operation button ( ) once.20

10.5 Light selection in automatic mode

• To switch between modes, press the mode button

. The product alternates between manual mode and automatic mode.

• When automatic mode is selected, the auto mode indicator light

flashes 5 times before the indicator light stays lit and the product starts the sequence.

• In automatic mode, if no action is taken for 3 seconds following the last adjustment, the timer begins its sequence: Red LED light for 5 minutes. Blue LED light for 3 minutes. Infrared light for 4 minutes. Mixed lights for 3 minutes.

• The product switches o automatically after completing the 15-minute sequence. 11 Risks and benefits Known risks

• Immediately after the treatment your skin may appear red. It should be back to normal within 1–2 hours. Known benefits

• Reduces facial fine lines and improves texture and pigmentation.

• Improves skin imperfections. 12 Care and maintenance WARNING! RISK OF ELECTRIC SHOCK!

• Always unplug the product from the power source before cleaning. NOTICE! RISK OF DAMAGE!

• Do not use any aggressive cleaners, brushes with metal bristles, or sharp or metallic cleaning utensils such as knives, hard scrapers, and the like.21

• Do not use hot water for cleaning.

12.1 Cleaning the neck mask

Clean the neck mask before and after each treament.

1. Unplug and turn o the neck mask

surface of the neck mask twice for 3 minutes. Then wipe with a damp or dry cloth.

3. Do not use benzene, thinner, butyl acetate and other

flammable materials for cleaning.

4. Do not spray water directly on the product.

• The product contains no serviceable parts. 13 Storage All parts must be completely dry before being stored.

• Store the product in a clean and dry place, avoiding heat and direct sunlight. Avoid storing in dusty conditions, in direct sunlight or in damp and humid conditions.

• Store the product so that it is not accessible to children.

• Store the product at room temperature in dry conditions.

• For best protection, store the product in its original packaging. 14 Troubleshooting Some problems may be caused by minor faults that you can fix yourself. To do so, follow the instructions in the following table. If it is still not possible to resolve the problem, contact customer service. Do not repair the product yourself.22

Problem Possible cause Solution The product does not operate. The power cable is not properly connected. Properly connect the cable. The mask is not connected properly. Properly connect the plug of the mask into the connector of the remote control. The operation button ( ) is not properly pressed. Press and hold the operation button ( ) to turn on the product. The battery level is low. Charge the remote control. LED lights do not turn on. The mask is not connected properly. Properly connect the plug of the mask into the connector of the remote control. The circuit board is faulty. Do not pull the power cord excessively. The power cord is pulled excessively. Flashing light during use/not possible to switch operating mode. The battery level is low. Charge the remote control. Cable connection is not properly made. Properly connect the plug of the mask into the connector of the remote control. The product is faulty. Return the product to the retailer.23

15 Technical data Model: FM-03 Rated input: 5 V 0.5 A Rated voltage: 3.7 V Battery capacity: 1,800 mAh Battery cycle life: ≥ 300 times Number of LED lights: 57 IP classification: IP22 Weight: 175.1 g Dimensions (L × W × H): 237 × 108 × 8.1 mm Classification of LS equipment: Exempt group 16 Service life The service life of the product is 1 year. 17 Manufacturer Manufactured for Silkn Beauty Ltd.: Alon Ha-Tavor 15 Caesarea, 3079516 Israel www.silkn.com • www.silkn.ca – [e-mail] 18 Disposal

18.1 Disposing of the packaging

Sort the packaging before you dispose of it. Dispose of paperboard and cardboard with the recycled paper service and wrappings with the appropriate collection service.24

18.2 Disposing of the product

Old appliances may not be disposed of in the household waste! Should the product no longer be capable of being used at some point in time, dispose of it in accordance with the regulations in force in your city or country. This ensures that old appliances are recycled in a professional manner and also rules out negative consequences for the environment. Batteries and rechargeable batteries may not be disposed of with household waste! As the end user you are required by law to bring all batteries and rechargeable batteries, regardless whether they contain harmful substances* or not, to a collection point run by the communal authority or to a retailer, so that they can be disposed of in an environmentally friendly manner. Bring the entire product (including the rechargeable battery) to your collection point and make sure that it is in an uncharged state!

• labelled with: Cd = cadmium, Hg = mercury, Pb = lead 19 Warranty This product is covered by a 1-year warranty. The extent of the warranty on this product is limited to technical defects caused by faulty production processes. In the event you want to claim warranty please be sure to contact our customer service for instructions. They may be able to solve your problem without needing to return the product to the store or our service center. Our customer service is always pleased to help you! 20 Customer service For more information about the products of Silk’n visit your regional Silk’n website: www.silkn.com. If the device is damaged, defective, in need of repair or you need our assistance, please contact your nearest Silk’n service center. This manual is also available as a PDF download from: www.silkn.com. Service number: 1-800-250-5053 Email: [e-mail]25

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15kV air Electrical fast transient/ burst IEC 61000-4-4:

±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines ±1 kV for input/output lines Surge IEC 61000-4-5:

±0.5 kV, ±l kV line(s) to lines ±0.5 kV, ±1 kV, ± 2 kV line(s) to earth ±0.5 kV, ±l kV line(s) to lines ±0.5 kV, ±l kV, ±2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11:

30 A/m 30 A/m Note: UT is the AC mains voltage prior to application of the best level.26

Table 3 Declaration – Electromagnetic emission Immunity test IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6:

6 V in ISM bands between

6 V in ISM bands between

Radiated RF IEC 61000-4-3:

10 V/m 80 MHz to 2.7 GHz 10 V/m Table 4 Declaration – IMMUNITY to proximity fields from RF wireless communications equipment Immunity test IEC60601 test level Compliance level Radiated RF IEC 61000- 4-3:2010 Tes t frequencuy Modulation Maximum power Immunity level 385 MHz **Pulse Modulation: 18 Hz

810 MHz 870 MHz 930 MHz **Pulse Modulation: 18 Hz 2 W 28 V/m 28 V/m **Pulse Modulation: 217 Hz 2 W 28 V/m 28 V/m Note *As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case. **The carrier shall be modulated using a 50 % duty cycle square wave signal.27

22 Environmental conditions Item Specification Operation environment Temperature 5 °C ~ 35 °C Humidity 85 % RH or less Atmospheric pressure 80–106 KPA Altitude ≤ 2,000 meters Storage environment Temperature -10 °C ~ +50 °C Humidity 85 % RH or less Atmospheric pressure 80–106 KPA Altitude ≤ 2,000 meters The external environment that the product can withstand:

1. The product can be placed in an environment with a

temperature of 60 ±2 °C and a humidity of 85 % +2 % RH for 48 hours, and then placed at room temperature for 2hours.

2. The product can be placed in an environment with a

temperature of -20 ±2 °C for 48 hours, and then placed at room temperature for 2 hours.

3. The product can be placed in an environment with a

temperature of 40 ± 3 °C and a humidity of 90 % ±2 % RH for 48 hours, and then placed at room temperature for 2 hours.

4. The product can be placed in an environment with a

temperature of 40 °C for 2 hours, and test related functions in this environment.

5. The product can be placed in an environment with a

temperature of 0 °C for 2 hours, and test related functions in this environment. 23 EMC manufacturer’s declaration and guidance

1. The product needs to take special precautions for electro-

magnetic compatibility (EMC), and the purchaser or user must install and use it according to the information about EMC compliance provided in the user manual.28

2. Portable and mobile radio frequency communication equip-

ment may aect the proudct. Please keep away from such equipment when using it.

3. In addition to the connecting wires and charging cables sold by

our company as spare parts of internal components, the use of accessories and cables outside the regulations may result in an increase in the emission of the product or a decrease in immunity. The following cable types must be used to ensure compliance with and adherence to interference radiation and immunity standards: Cable Length (m) Power cord 0.5 Charging Cable 0.5

4. This product should not be used close to or stacked with

other equipment. If such use is necessary, the product should be observed to verify that it can operate normally under the configuration used.

5. This product should not touch the pins of the connectors

marked with the electrostatic discharge warning symbol, and should not be connected to these connectors unless electro- static discharge precautions are used. Provisions on preventive measures against electrostatic discharge: Human body or objects carry dierent electrostatic voltages due to charge transfer; since electrostatic discharge is completed in the order of ns or μs, the peak current can reach tens of amperes, and the instantaneous power is very huge. The resulting electrostatic discharge is electromagnetic. The pulse energy is enough to damage the sensitive components in the electronic components; because the rise time of the current waveform is very short, that is, the rate of change of the current (di/dt) is very large, it can induce a high potential of hundreds of volts or even thousands of volts, thereby a strong electric field is generated to break down the sensitive element. In order to prevent damage to the instrument, the following measures should be taken: (1) Ensure the environmental humidity; (2) Laying anti-static floor or carpet;29

(3) The operator should wear an anti-static hand strap on the wrist. This hand strap should have good grounding performance. This measure is the most eective.

6. The basic performance of the product:

red light mode – radiation intensity Ee ≤ 96 mW/cm

blue light mode – radiation intensity: Ee ≤ 120 mW/cm

7. The guidelines and the company’s statement are shown in

Table 1 to Table 4: This product meets the electromagnetic compatibility requirements of IEC60601-l-2/AMD1:2020 PRV idt lEC60601-l-2:2004; Guidelines and manufacturer’s declaration – electromagnetic emissions – for all equipment and systems Table 1 Electromagnetic radiation (corresponding to Table 201 in lEC 60601-l-2/AMDl:2020 PRV) Guidelines and manufacturer’s declaration – Electromagnetic emissions The product is expected to be used in the electromagnetic environment specified below. The purchaser or user of the product should ensure that it is used in the electromagnetic environment. Launch test Compliance Electromagnetic environment-guide RF emission CI SR P11: 2O16 Team 1 The product uses radio frequency energy only for its internal functions. Therefore, its radio frequency emission is very low and the possibility of causing interference to nearby electronic equipment is very small. RF emission CI SR P11: 2O16 Type B The product is suitable for use in all facilities, including households and directly connected to the residential public low-voltage power supply network for house- holds. Harmonic emission 1EC 61000-3-2:2009 Type A Voltage fluctuation/flicker emission 1EC 61000-3-2:2009 Correspond Guidelines and manufacturer’s declaration – electromagnetic immunity – for all equipment and systems: This product is expected to be used in the electromagnetic environment specified below. The purchaser or user of this product should ensure that it is used in this electromagnetic environment.30

Table 2 Electromagnetic immunity 1 (corresponding to Table 202 in IEC 60601-1-2/AMDl:2020 PRV) Guidelines and manufacturer’s declaration – Electromagnetic immunity The product is expected to be used in the electromagnetic environment specified below and the purchaser or user of the product should ensure that it is used in this environment. Immunity test IEC60601 test level Coincidence level Electromagnetic environment-guide Electrostatic discharge IEC 61000-4-2:2008 +6 kV Contact discharge ±8 kV Air discharge ±6 kV Contact discharge ±8 kV Air discharge The floor should be wood, concrete, or ceramic tiles. If the floor is covered with a contaminated material, the relative humidity should be at least 30 %. Voltage transient burst IEC 61000-4-4:

±2 kV To the power cord ±l kV To input/ output cord ±2 kV To the power cord Not applicable The network power supply should have the quality used in a typical commercial or hospital environment. Surge IEC 61000- 4-5:2014 ±2 kV line to line ±1 kV line to ground +2 kV line to line Not applicable The network power supply should have the quality used in a typical commercial or hospital environment. The voltage on the voltage input line is temporarily Iow, short-term interruption and voltage change 1EC 61000- 4 -11: 2004 < 5 % UT lasting for 0.5 weeks (at UT 95 % temporary low) 40 % UT for 5 weeks (on UT a temporary low of > 60 %) 70 % UT for 25 weeks (at UT a temporary low of > 30 %) 5 % UT lasting 5s (at UT a temporary low of > 95 %) < 5 % UT lasting for

> 95 % temporary low) 40 % UT for 5 weeks (on UT a temporary low of > 60 %) 70 % UT for 25 weeks (at UT, a temporary low of > 30 %) 5 % UT lasting 5s (at UT a temporary low of > 95 %) The network power supply should have the quality used in a typical commercial or hospital environment. If the user of the product needs to continue to operate during the power interruption, it is recommended that the product be powered by an uninterrupted power supply or battery.31

Power frequency magnetic field (50 Hz) 1EC 61000-4-8:2001 3 A/m 3 A/m If image distortion occurs, the product must be placed farther a way from the source of the power frequency magnetic field or a magnetic shielding protection must be installed. The power frequency magnetic field should be measured to ensure that the installation position is suciently low when it is expected to be used. Note: UT refers to the AC network voltage before the test voltage is applied. Guidance and manufacturing statement – electromagnetic immunity – for non-life support equipment and systems Table 3 Electromagnetic immunity (corresponding to Table 204 in I EC 60601-l-2/AMDl:2020 PRV) Guidelines and manufacturer’s declaration – Electromagnetic immunity The product is expected to be used in the electromagnetic environment specified below and the purchaser or user of the product should ensure that it is used in this environment. Immunity test IEC60601 test level Coincidence level Electromagnetic environment-guide Radio frequency conduction 1EC 61000-4-6:

Radio frequency radiation 1EC 61000-4-3:

3 V (Eective value) 150 kHz–80 MHz 3 V/m 80 MHz–2.5 GHz 3 V (Eective value) 3 V/m Portable and mobile radio frequency communication equipment should not be used closer to any part of the product, including cables, than the recommended isolation distance. This distance should be calculated based on the formula corresponding to the transmitter frequency. Recommended isolation distance d = 1.2 √p d = 1.2 √p 80 MHz–800 MHz d = 2.3 √p 80 MHz–2.5 GHz32

In the formula: P-According to the maximum rated output power of the transmitter provided by the transmitter manufacturer, nwatts; d-Recommended isolation distance, in meters, the field strength of the fixed radio frequency transmitter is deter- mined by surveying the electromagnetic fields, and in each frequency range b should be lower than the compliance level. Interference may occur in the vicinity of equipment marked with the following symbols. Note 1: At 80 MHz and 800 MHz frequency points, the higher frequency band formula is used. Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is aected by absorption and emission from buildings, objects and humans. a: Fixed transmitters, such as base stations for wireless (cellular/cordless) telephones and terrestrial mobile radios, business radios, AM and FM radio broadcasting, and TV broadcasting. The field strength cannot be accurately predicted theoretically. In order to assess the electromagnetic environment of fixed radio frequency transmitters, the survey of electromagnetic fields should be considered. If the measured field strength of the place where the product is located is higher than the above-mentioned applicable radio frequency compliance level, the product should be observed to verify its normal operation. If abnormal performance is observed, supplementary measures may be necessary, such as re-adjusting the direction or position of the product. b: In the entire frequency range of 150 kHz–80 MHz, the field strength should be less than 3 V/m. Recommended isolation distance between portable and mobile RF communication equipment and this product or system – for non-life support equipment or systems.33

Table 4 Safety distance (corresponding to Table 206 in lEC 60601-l-2/AMDl:2020 PRV) Recommended isolation distance between portable and mobile RF communication equipment and the product or system The product is expected to be used in an electromagnetic environment where radiated RF disturbances are controlled. According to the maximum output function of the communication device, the purchaser or user of the product can prevent electromagnetic interference by maintaining the minimum distance between the portable and mobile RF communication device (transmitter) and the product as recommended below. Rated maximum output power of the transmitter/

Corresponding to the isolation distance of the transmitter at dierent frequencies/m 150 kHz–80 MHz d = 1.2 √p 80 MHz–800 MHz d = 1.2 √p 80 MHz–800 MHz d = 2.3 √p

For the maximum rated output rate of the transmitter not listed in the above table, the recommended isolation distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency column, where P is provided by the transmitter manu- facturer. The maximum rated output power of the transmitter; in watts (W). Note 1: At 80 MHz and 800 MHz frequency points, the formula for the higher frequency range should be used. Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is aected by absorption and reflection from buildings, objects, and humans.34