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2 English / 01 Ambicare Health Ltd, ALBA Innovation Centre, Alba Campus, Livingston, EH54 7GA, Tel +44 (0) Ambicare is an ISO 13485:2003 certified company Ambicare Health Ltd All rights reserved. Lustre, Lustre Pure Light, Lustre Pure Light treatment for acne and Lustre adhesive strips are trademarks of Ambicare Health.

3 English / Contents Introduction 4 What causes spots? 7 How Lustre Pure Light works the science 9 Package contents 11 Indication for use 11 Contraindications, warnings and precautions 12 Lustre controller screen indicator menu 13 Charging the Lustre controller 14 Keys 14 Turning the Lustre Pure Light On/Off 15 First time set up 15 Unlocking the keypad 18 Warnings 19 Skin preparation before treatment 20 Using Lustre Pure Light 21 Attaching the Lustre therapy heads to the treatment area 22 Connecting the Lustre therapy heads to the Lustre controller 24 Setting the treatment time 25 During treatment 26 After treatment 26 Unlocking the PIN 28 Battery 29 Cleaning 29 Warranty 30 Disposal 31 Specification 31 English 1

4 Lustre controller Lustre therapy heads Power adaptor Lustre adhesive strips Lustre instruction manual English

5 Congratulations on your purchase of Lustre To register your product and be kept up-to-date with new and exciting developments from the Lustre team, please take a moment to sign up on our website Your device is guaranteed for 12 months from the date of purchase. To register you will need to enter your serial and batch number codes which you can locate on your Lustre controller. We look forward to welcoming you!

6 Welcome to Lustre Pure Light treatment for acne You have probably purchased Lustre Pure Light because you have tried many different products to treat your spots. Lustre Pure Light harnesses the safe blue part of the natural visible light spectrum. This blue light has been clinically proven to eliminate the bacteria that cause 1, 2, 3 spots, whilst being gentle on your skin. We hope you enjoy using Lustre Pure Light. We would like to keep in touch and share your Lustre Pure Light journey with you. Your Lustre Pure Light device is guaranteed for twelve months from date of purchase, please register at and let us know how you are getting on! Lustre Pure Light is portable and, because the light therapy is delivered while you wear it, you are free to get on with the things you want to get on with. 4 English

7 Before starting treatment you must attach the Lustre therapy heads to your skin so that they are situated over the treatment area. It is important that you place the Lustre therapy heads in the same place for each treatment. The key to achieving success during treatment is to keep treating the same area. It is recommended that Lustre Pure Light treatment for acne is used every day and to achieve the best results Lustre Pure Light should be used for a total of 8 hours per week. Each person is different, but if you use the Lustre Pure Light as recommended, you may see an improvement in as little as 4 weeks. Clinical evidence shows that the best results are seen after 8 12 weeks. 1 The more that you use Lustre Pure Light treatment for acne, the better your results are likely to be. English 5

8 6 English

9 What causes spots? Hair follicle Sebum Sebaceous Gland Many treatments for spots help to unblock pores and dry up sebum and can help reduce the spots when they appear. Lustre Pure Light has clinically proven technology which has been shown to destroy the spot causing bacteria and by reducing the number of bacteria on the skin can help stop spots forming in the first place. P. acnes is a bacteria which normally lives on skin. Under certain circumstances, often associated with hormonal, lifestyle or diet changes the sebaceous gland will over produce a natural oil called sebum. As sebum production increases the spot causing bacteria, P. acnes begin to grow and multiply more rapidly. English 7

10 As this process continues hair follicles may become blocked. The increasing amount of sebum together with the P. acnes bacteria and dead skin cells, cause a plug to form. 8 English As the sebum and bacteria continue to grow, white blood cells move into the area and begin to fight the bacteria, this causes swelling or inflammation, and a spot forms. This process will continue until the white blood cells have managed to fight the P. acnes infection and the inflammation stops or until the pore is unblocked and the sebum levels are reduced.

11 How Lustre Pure Light works the science Porphyrin Scientists have discovered that the spot causing bacteria, P. acnes produce a normally harmless chemical called Porphyrin. Lustre Blue Light P. acnes (spot causing bacteria) Clinical trials have proven that when safe natural visible blue light at 415 nm is shone onto the skin there is no harm to the skin itself, but the Porphyrins produced by the spot causing bacteria become excited. 1,2, 3 English 9

12 Lustre Pure Light delivers safe, visible blue light at a wavelength of 415 nm which has been clinically proven to destroy the bacteria that cause spots. With prolonged use, Lustre Pure Light can continue to destroy P. acnes reducing the number of new spots forming. When the spot causing bacteria P. acnes has been destroyed acne begins to clear and continued blue light use can help reduce P. acnes growth and stop new spots forming. When Porphyrins become excited they attach to the spot causing bacteria and begin to destroy it. 10 English

13 Package contents The Lustre Pure Light treatment for acne starter pack contains the following elements; Indication for use The Lustre Pure Light treatment for acne is indicated for the treatment of mild to moderate inflammatory acne. Lustre controller 1 Lustre therapy heads 2 Power adaptor 3 Supply of Lustre adhesive strips Lustre instruction manual 5 4 Note: The Lustre therapy heads are very delicate, they are designed to be gently bent from a slightly curved position to a flat position. If they are bent further than this they may break, and this will invalidate the warranty. English 11

14 Contraindications, safety and warnings Read all of the instructions before using Lustre Pure Light treatment for acne. Please consult your healthcare practitioner before using Lustre Pure Light if you are taking any prescription medication for Acne. Contraindications Do Not use Lustre Pure Light if you have a history of; porphyria, solar urticaria, chronic actinic dermatitis, photosensitvity. Do Not use Lustre Pure Light over any suspicious or cancerous lesions. Do Not use Lustre Pure Light if you are taking amiodarone. Do Not use Lustre Pure Light if you are taking any photosensitising treatment. Do Not use Lustre Pure Light over or near a recent steroid injection. 12 English Do Not use Lustre Pure Light on children under 13 years old. Warnings Do Not place Lustre Pure Light over the eyes, or where the light will shine into the eyes during treatment. Always use the charger that was supplied with Lustre Pure Light treatment for acne. Always keep Lustre Pure Light away from water and moisture. Never insert objects into the openings of the Lustre Pure Light. Never use Lustre Pure Light if it appears damaged or if any of the power cables appear damaged. Never disassemble Lustre Pure Light. Do Not allow any fluid to enter Lustre Pure Light at any time. If this happens do not use. The Lustre adhesive strips should always be carefully removed to help avoid damage to the skin. Lustre is NOT recommended for pregnant women. The safety of the treatment for pregnant women has NOT been tested and the risk is unknown.

15 Lustre controller screen indicator menu Review mode indicator Review mode date indicator Lustre controller screen Sound level indicator Battery Indicator Temperature warning symbol Time mode indicator Therapy head connection / Use indicator Time remaining / PIN indicator Settings mode indicator Key pad lock indicator Select key indicator Charging the Lustre controller English 13

16 Charging the Lustre controller Connect the power Charging adaptor to the the controller Lustre and controller plug the charger into a mains power socket. Then switch the power socket on. Keys The Lustre controller has the following keys. The battery icon will appear on the screen during charging. The Charging battery will the take Lustre approximately controller 6 hours to fully Keys charge. When fully charged the Lustre controller has a 4 day standby time or a 90 minute treatment time, when three Lustre therapy heads are attached. We advise that the Lustre Keys controller is recharged following every treatment session to ensure sufficient power for the next session. Down key Use to decrease a number. Also used to unlock the controller (in combination with Select key). Select key Use to select or accept a function, and to the turn the Lustre controller on and off. Up key Use to increase a number. Also used to enter review mode (in combination with Select key). 14 English

17 Turning the Lustre controller On/Off 3 Charging the Lustre controller Keys To turn the Lustre unit on, press and hold the select key for 2 seconds. First Time Setup Sound Level The first time Lustre Pure Light is used the sound level should be set. The sound level can be set in settings mode. To enter the settings mode at any time, press and hold the select key. 4 Keys To turn the Lustre controller unit off press and hold the select key for 2 Seconds. When the Lustre controller is in settings mode the volume icon will flash. By pressing the up and down keys the volume level can be set. When the required volume level has been selected, press the select key to proceed to the date settings. English 15 5 Sound Level

18 5 Sound Level 5 Sound Level Sound Level continued p p Date When the volume has been set, the day icon Date will start to flash. Press the up and down keys to select the day. Date Date Date Change volume by pressing the up/down keys Set day Change date by pressing up/down keys Select volume by pressing the select key 16 Date English Date p.17 p.17 PIN Date Date PIN Unlo

19 Date continued When the current day has been selected, press the select key. The month icon will start to flash. Date Select the current month and press the select key. You will then move on to the PIN settings. PIN When the date has been set, a 2 digit PIN (Personal Identification Number) can be entered. This is an optional step. Press the up and down keys to modify the first digit of the PIN. Then press the select key to move onto the second digit of the PIN. Set month Select date by pressing select key Press the up and down keys to modify the second digit of the PIN. Then press the select key. Please make a note of this PIN. The PIN will need to be entered every time the Lustre Pure Light is used. The PIN option will not be activated if these digits are left blank. If the PIN is lost or forgotten at any time then it can be reset by entering the settings mode as described above. Unlocking the Keypad Unlocking the Keypad English 17

20 17 17 p.17 PIN PIN continued Unlocking the Keypad Keypad Unlocking the Keypad Unlocking the Keypad The keypad will auto-lock if no keys are pressed for 15 seconds. To unlock the keypad press and hold the down key then press the select key whilst holding the down key. Release both keys. Unlocking the Keypad 1 (hold) 2 Use up and down keys to choose PIN digit p.18 Warning Use the select key to confirm the digit choice 18 English 18 Warning

21 p.17 PIN Unlocking the Keypad Warnings Lost Connection If any of the Lustre therapy heads are detached from the Lustre controller during a treatment, all of the heads will shut down and the following warning will be shown on the screen. The Lustre controller will beep every 5 seconds. When all the Lustre therapy heads have been reconnected, the treatment will automatically resume from the point at which it had been interrupted. Adhesion of Strips p.18 Warning Do not use for more than 70 minutes a day, on any given treatment area. This may cause some transient discolouration. Lost connection warning display High temperature warning display High Temperature In the unlikely event that one of the Lustre therapy heads overheats a built in safety mechanism will switch off all of the therapy heads until they reach a safe level. p.24 Setting the Treatment Time English 19

22 Skin Preparation before treatment Before using the Lustre Pure Light ensure skin is clean and dry and that all make-up is removed. Wash skin with normal cleanser or with a mild soap and warm water. Ensure skin is dry after cleansing and before using the Lustre Pure Light, if other topical treatments for acne are being used these should be applied following the Lustre Pure Light treatment session. Use of Adhesive Strips Care should be taken when removing the Lustre adhesive strips from the treatment area to avoid causing trauma to the treatment area. If you do have any sensitivity to the adhesiveness of the strips then a small amount of moisturising cream can be applied to the skin to reduce the adhesiveness. Ensure that the cream is not visible on your skin before you apply the therapy heads so that the cream does not block the light. Should you find that the strips are not adhesive enough then please ensure that you have thoroughly cleaned your skin before applying the therapy heads. If any problems persist, discontinue use, and then please contact info@lustrepurelight.com 20 English

23 Using Lustre Pure Light It is recommended that Lustre Pure Light treatment for acne is used every day and to achieve the best results Lustre Pure Light should be used for a total of 8 hours per week. Each person is different, but if Lustre Pure Light is used as recommended, an improvement may be seen in 4 weeks. Clinical evidence has shown that the best results are seen after 8-12 weeks. 1,2,3 Before commencing treatment the Lustre therapy heads need to be attached to the area to be treated. It is important that you place the Lustre therapy heads in the same place for each treatment. DO NOT place the Lustre therapy heads over your eyes, or in a place where the light may shine into your eyes during the treatment. To attach the Lustre therapy heads to the treatment area, the Lustre adhesive strips are used. One Lustre adhesive strip is used per Lustre therapy head. It is not recommended to re-use Lustre adhesive strips as this may transfer acne bacteria between treatments and may affect their ability to attach the Lustre therapy heads to your skin correctly. Additional Lustre adhesive strips can be purchased from English 21

24 Attaching the Lustre therapy heads to the treatment area Lustre adhesive strips are used to attach the therapy heads to the treatment area. Step 1 Step 2 Step 4 22 English

25 Attaching the Lustre Therapy Heads to the treatment area continued Step 1 Remove the Lustre adhesive strip from the box and unpeel one side from the backing paper. Step 2 Place the exposed adhesive side of the strip onto the flat surface of the Lustre therapy head ensuring that the strip aligns with the shape of the Lustre therapy head. Step 3 Press down firmly across the entire surface of the Lustre adhesive strip so that it sticks firmly to the Lustre therapy head. Step 4 Peel the top layer of backing paper from the Lustre adhesive strip, to expose the other adhesive surface of the Lustre adhesive strip. Step 5 The Lustre therapy head and Lustre adhesive strip can then be attached to the treatment area. Repeat steps 1 to 5 to attach Lustre therapy heads to additional treatment areas. 1, 2 or up to 3 Lustre therapy heads can be connected to the Lustre controller depending on the number of areas to be treated. English 23

26 Connecting the Lustre therapy heads to the Lustre controller Once the Lustre therapy heads are attached to the treatment area, they should be connected to the Lustre controller. Each Lustre therapy head is inserted into connections on the Lustre controller. 1, 2 or 3 Lustre therapy heads can be attached to the Lustre controller depending on the number of areas you wish to treat. Once the Lustre therapy heads are attached to your skin, and connected to the Lustre controller, you can turn the Lustre controller on. Each therapy head will appear individually as they are connected to the controller as a solid bar on the facial diagram of the display screen. The location shown on the diagram is for illustration purposes and does not directly relate to the treatment area which the therapy heads are actually attached to. 24 English

27 Setting the Treatment Time A treatment time should be selected prior to commencing a treatment session. It is recommended that Lustre Pure Light treatment for acne is used every day and to achieve the best results Lustre Pure Light should be used for a total of 8 hours per week. p.24 Setting the Treatment Time When the Lustre therapy heads have been connected to the Lustre controller, press the select key to switch the controller on. The treatment time indicator will flash, press the up and down keys as required to select the treatment time required. The treatment time can be varied between 5 and 60 minutes per treatment session. p.25 p.25 Decrease Increase Decrease Increase Select Treatment time During Treatment English 25

28 p.25 During Treatment When the treatment time has been selected, press the select key to start. When the treatment starts, the Lustre therapy heads on the screen will flash to show that the treatment is progressing. The timer will also count down and show how many minutes are remaining of the current treatment. During Treatment After Treatment When the treatment timer reaches zero, the Lustre controller will automatically turn the therapy heads off. The controller will remain on until it is turned off, to inform you that the treatment is complete. To remove the Lustre therapy heads from the treatment area carefully and slowly pull the Lustre adhesive strip using the adhesive strip removal tab. Be careful to pull gently so that you don t harm your skin. p.26 Reviewing 26 English your past treatments

29 After treatment continued Ensure that the Lustre therapy head does not bend. Carefully pull the Lustre adhesive strip from the therapy head, and discard it. Lustre adhesive strips should only be used once. After treatment clean and dry the treated area as before treatment. English 27

30 Unlocking the PIN If a PIN has been entered during set up, every time the Lustre Pure Light controller is switched on a PIN code will be requested. p.28 Unlocking the PIN p.28 Unlocking the PIN Choose the PIN number by pressing the up/down key Press the up and down keys to select the number for the first digit of the PIN. When the number has been selected press the select key and move on to the second digit of the PIN. When you have chosen the number, press the select key Once the correct PIN is entered the device is ready for use. 28 English p.29 p.29 Battery

31 9 Battery Warning, the Lustre Pure Light will automatically turn off if the battery is too low. We advise that the Lustre controller is recharged following every treatment session to ensure sufficient power for the next session. Cleaning Lustre Pure Light is not waterproof. If the Lustre Pure Light requires cleaning at any time, use a soft dry cloth or a cleansing wipe. Do not allow any fluid to enter any part of the Lustre Pure Light, this includes cleaning detergent. If this happens do not use. For hygiene reasons do not share Lustre Pure Light with anyone else. English 29

32 Warranty Lustre Pure light treatment for acne is warranted to be free from defects in material and workmanship for a period of 12 months from its original purchase date under normal use. This warranty extends only to the original retail purchaser with original proof of purchase and only when purchased from an authorised retailer or reseller. If the product should become defective within the warranty period, contact the retailer that you purchased the device from. This warranty does not cover products damaged by: Accident, misuse, abuse or alteration, this includes the therapy heads. Use with unauthorised accessories or use other than as instructed Connecting to incorrect current and voltage Servicing by unauthorised persons 30 English

33 Disposal Waste Electrical and Electronic Equipment (WEEE) Do not dispose of the device with normal domestic waste at the end of its life. Please take it to an official recycling point to be disposed of correctly. In order to recycle this device you can return it to Ambicare Health. Specifications Product Name: Lustre Pure Light treatment for acne Model Number: PR2001 Operating Wavelength: 415nm +/- 10nm Operating Temperature / Humidity: 10 C to 40 C / 20% to 85% Storage and Transport Temperature / Humidity: -5 C to 60 C / less than 85% Mains Electrical Input: 220V/50Hz/220mA Mains Charger Electrical Output: 12V/1000mA English 31

34 References 1 Phototherapy with blue (415nm) and red (660 nm) light in the treatment of acne vulgaris. Papageorgiou et al British Journal of Dermatology 2000; 142: An open study to determine the efficacy of blue light in the treatment of mild to moderate acne. Morton et al. Journal of Dermatological Treatment. 2005; 16: Phototherapy in the treatment of Acne Vulgaris- What is the role? Charakida et al American Journal of Clinical Dermatology 2004; 5(4): English

35 General Safety/EMC and Electrical Information for the Lustre Device 1. General Safety 1.1 The Lustre device is an electrical device, which under certain circumstances could present an electrical shock hazard to the user. Please read the accompanying user manual thoroughly and follow directions stated in the manual to assure maximum safety during charging and operation. 1.2 EN : Protection against electrical shock Class II Degree of protection against electrical shock Type B Applied Part Degree of protection against ingress of water IP Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide 1.3 EMI/EMC Compliance against standard EN : LED lighting (Blue Light) Compliance against standard EN62471:2008 English 33

36 2. Electromagnetic Compatibility (EMC) 2.1 Important information regarding Electro Magnetic Compatibility (EMC) In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN :2007 standard has been implemented. This standard defines levels of electromagnetic emissions for medical devices. The Lustre Device manufactured by Ambicare Health Ltd conforms to this EN :2007 standard for both immunity and emissions. Refer to further guidance below regarding the EMC environment in which the device should be used. 34 English

37 Guidance and manufacturer s declaration electromagnetic emissions Lustre Device is intended for use in the electromagnetic environment specified below. The customer or the user of Lustre Device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Not applicable Lustre Device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Lustre Device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. English 35

38 Guidance and manufacturer s declaration electromagnetic immunity Lustre Device is intended for use in the electromagnetic environment specified below. The customer or the user of Lustre Device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC ±6 kv contact ±8 kv air ±6 kv contact ±8 kv air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Portable and mobile RF communications equipment should be used no closer to any part of the Lustre Device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 36 English

39 Immunity test IEC test level Compliance level Electromagnetic environment guidance Electrical fast transient/burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply IEC Power frequency (50/ 60 Hz) magnetic field IEC Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable The Lustre Pure Light Acne Treatment Device doesn t operate while being charged and no electricity is required for operation of the device. For operation of the device by the user the device is power via SELV battery. English 37

40 Guidance and manufacturer s declaration electromagnetic immunity Lustre Device is intended for use in the electromagnetic environment specified below. The customers or the user of Lustre Device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Conducted RF IEC Not applicable Not applicable Portable and mobile RF communications equipment should be used no closer to any part of the Lustre Pure including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommended separation distance d = 1.2 P d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). 38 English

41 Immunity test IEC test level Compliance level Electromagnetic environment guidance Radiated RF IEC V/m 80 MHz to 2.5 GHz 3 V/m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Lustre is used exceeds the applicable RF compliance level above, Lustre should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Lustre. English 39

42 Recommended separation distance between portable and mobile RF communications equipment and the Lustre Device Lustre Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the user of Lustre Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Lustre Device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter in Watt Separation distance according to frequency of transmitter in meters 150 khz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5GHz d = 2.3 P English

43 Rated maximum output power of transmitter in Watt 150 khz to 80 MHz d = 1.2 P Separation distance according to frequency of transmitter in meters 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5GHz d = 2.3 P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. English 41

44 3. Explanation of Symbols on Technical Label Refer to operating instructions Class II equipment provides double Isolation to protect against electric shock IP40 Degree of protection IP40 Protection against penetration by solid particles with diameters larger than 1 mm. No special protection against penetration by water Batch/Lot/ID Number For the Lustre Device: Each device has a guaranteed unique batch /id number example: :2012 The 7 digit number is the unique batch/id for the device and the then the year of manufacture of the device is added Expiry date of Lustre Adhesive Strips 42 English

45 WEEE Compliance Catalogue number Manufacturer Quantity of Lustre Adhesive Strips Keep Dry English 43

46 Do not reuse Single Use Store in a clean dry area up to 24 C Lustre Adhesive Strips 4. Customer Service/Contact Information: Ambicare Health Ltd, ALBA Innovation Centre, Alba Campus, Livingston, EH54 7GA, Tel: +44 (0) English

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