2AU6O-ABBTE2AB Sound Processor with 4.2

Naída CI M30 Sound Processor CI-5294 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, USA +1 661 362 1400 AdvancedBionics.com 029-M797-A2 Rev A 2020-03-02 SYMBOLS TABLE: Labeling symbols and their meanings: Date of Manufacture Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF Suitable temperature range for transport and storage See Instructions for Use Fragile Suitable relative humidity range for transport and storage Caution (refer to “Cautions & Warnings” section for further information) Dispose of in accordance with applicable national and local regulations MR Unsafe IPXX Ingress Protection Rating LIMITATIONS AND CONTRAINDICATIONS: There are no known limitations or contraindications for the Naída CI M30 sound processor. PRECAUTIONS, CAUTIONS, AND WARNINGS:  This device should be used only by the individual for whom it is prescribed.  CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) may cause bodily harm. If any parts are swallowed or inhaled, consult a physician or hospital immediately.  Ensure appropriate supervision when child is wearing the Naída CI M30 sound processor and accessories. Do not allow children to play with or leave them unattended with the sound processor or any of its accessories.  Power supplies and battery chargers should be operated in an open area to ensure adequate airflow. While no injury cases have resulted, components may become hot during normal use or a fault condition. If the device’s temperature results in discomfort or pain when touched, disconnect the power source and contact your local Advanced Bionics representative.  Do not use any other power supply with the sound processor or accessories unless it is supplied by Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement.  Do not use accessories when they are plugged into power sources such as wall outlets, or other power sources that are USB compatible (e.g. laptops).  Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes.  Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car).  Remove batteries from your sound processor when they are drained to prevent damage from possible leaking.  Do not dispose of batteries in fire.  High levels of static electricity may damage electronic components of your sound processor or implant. Care should be taken to avoid exposure of the system to static electricity.  Do not attempt to pair your sound processor to any accessories while driving or operating heavy machinery.  Do not stream audio to your sound processor while driving or operating heavy machinery.  Attenuating ambient sounds or adjusting environmental balance while streaming audio (either with the multifunction button or with the mobile application) may compromise situational awareness.  Use your sound processor for hands-free phone use only where permitted by law and only when you will not be distracted from the safe operation of your vehicle.  Do not use your Advanced Bionics wireless accessories when instructed not to use wireless electronic devices, such as on airplanes.  Remove your sound processor and headpiece before entering a room where an MRI scanner is located.  Remove your sound processor and consult your cochlear implant professional if uncomfortable sounds are heard or in case of discomfort, pain or skin irritation.  If the sound processor or accessories become unusually hot or warm, discontinue use immediately and contact Advanced Bionics or your cochlear implant professional.  The large Slim HP Color Cap is for use by recipients older than 3 years of age, as this color cap and the Slim HP magnet may become displaced upon dropping.  It is important to have the correct magnet strength, so you do not experience discomfort or retention issues. If magnet strength is insufficient, the headpiece may fall off more than is acceptable. If magnet strength is excessive, you may experience irritation or discomfort. Consult your cochlear implant professional if there are any concerns regarding magnet strength. If deemed appropriate, an audiologist may change the strength of the magnet in the headpiece. Do not change magnet strength unless under the direction of a cochlear implant professional. If you experience any redness, irritation, or discomfort, discontinue use of the headpiece immediately and contact a cochlear implant professional. See the headpiece instructions for use for additional information regarding adjustment of headpiece magnet strength.  Store additional headpieces away from items with magnetic strips (e.g., credit cards, hotel room keys, etc.) as they may de-magnetize cards.  The digitally-coded, inductive transmission technology used in this device is extremely reliable and experiences virtually no interference from other devices. It should be noted, however, that when operating the device near a computer terminal or other strong electromagnetic field (e.g. RFID system), it may be necessary to be at least 24” (60 cm) away to ensure proper operation. If the Naída CI M30 sound processor does not respond to the implant device because of an unusual field disturbance, move away from the disturbing field.  The Naída CI M30 sound processors and accessories should be used in accordance with the electromagnetic compatibility information provided in the Guidance and Manufacturer’s Declaration section of this document.  Although electromagnetic emissions of your Naída CI M30 sound processor have been confirmed within safe limits, some other devices could be sensitive to such emissions. If you notice other devices do not behave as expected when your sound processor is nearby, separate the devices.  Portable and mobil…

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Naída CI M90 Sound Processor CI-5293 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, USA +1 661 362 1400 AdvancedBionics.com 029-M796-A2 Rev A 2020-03-02 SYMBOLS TABLE: Labeling symbols and their meanings: Date of Manufacture Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF Suitable temperature range for transport and storage See Instructions for Use Fragile Suitable relative humidity range for transport and storage Caution (refer to “Cautions & Warnings” section for further information) Dispose of in accordance with applicable national and local regulations MR Unsafe IPXX Ingress Protection Rating LIMITATIONS AND CONTRAINDICATIONS: There are no known limitations or contraindications for the Naída CI M90 sound processor. PRECAUTIONS, CAUTIONS, AND WARNINGS:  This device should be used only by the individual for whom it is prescribed.  CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) may cause bodily harm. If any parts are swallowed or inhaled, consult a physician or hospital immediately.  Ensure appropriate supervision when child is wearing the Naída CI M90 sound processor and accessories. Do not allow children to play with or leave them unattended with the sound processor or any of its accessories.  Power supplies and battery chargers should be operated in an open area to ensure adequate airflow. While no injury cases have resulted, components may become hot during normal use or a fault condition. If the device’s temperature results in discomfort or pain when touched, disconnect the power source and contact your local Advanced Bionics representative.  Do not use any other power supply with the sound processor or accessories unless it is supplied by Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement.  Do not use accessories when they are plugged into power sources such as wall outlets, or other power sources that are USB compatible (e.g. laptops).  Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes.  Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car).  Remove batteries from your sound processor when they are drained to prevent damage from possible leaking.  Do not dispose of batteries in fire.  High levels of static electricity may damage electronic components of your sound processor or implant. Care should be taken to avoid exposure of the system to static electricity.  Do not attempt to pair your sound processor to any accessories while driving or operating heavy machinery.  Do not stream audio to your sound processor while driving or operating heavy machinery.  Attenuating ambient sounds or adjusting environmental balance while streaming audio (either with the multifunction button or with the mobile application) may compromise situational awareness.  Use your sound processor for hands-free phone use only where permitted by law and only when you will not be distracted from the safe operation of your vehicle.  Do not use your Advanced Bionics wireless accessories when instructed not to use wireless electronic devices, such as on airplanes.  Remove your sound processor and headpiece before entering a room where an MRI scanner is located.  Remove your sound processor and consult your cochlear implant professional if uncomfortable sounds are heard or in case of discomfort, pain or skin irritation.  If the sound processor or accessories become unusually hot or warm, discontinue use immediately and contact Advanced Bionics or your cochlear implant professional.  The large Slim HP Color Cap is for use by recipients older than 3 years of age, as this color cap and the Slim HP magnet may become displaced upon dropping.  It is important to have the correct magnet strength, so you do not experience discomfort or retention issues. If magnet strength is insufficient, the headpiece may fall off more than is acceptable. If magnet strength is excessive, you may experience irritation or discomfort. Consult your cochlear implant professional if there are any concerns regarding magnet strength. If deemed appropriate, an audiologist may change the strength of the magnet in the headpiece. Do not change magnet strength unless under the direction of a cochlear implant professional. If you experience any redness, irritation, or discomfort, discontinue use of the headpiece immediately and contact a cochlear implant professional. See the headpiece instructions for use for additional information regarding adjustment of headpiece magnet strength.  Store additional headpieces away from items with magnetic strips (e.g., credit cards, hotel room keys, etc.) as they may de-magnetize cards.  The digitally-coded, inductive transmission technology used in this device is extremely reliable and experiences virtually no interference from other devices. It should be noted, however, that when operating the device near a computer terminal or other strong electromagnetic field (e.g. RFID system), it may be necessary to be at least 24” (60 cm) away to ensure proper operation. If the Naída CI M90 sound processor does not respond to the implant device because of an unusual field disturbance, move away from the disturbing field.  The Naída CI M90 sound processors and accessories should be used in accordance with the electromagnetic compatibility information provided in the Guidance and Manufacturer’s Declaration section of this document.  Although electromagnetic emissions of your Naída CI M90 sound processor have been confirmed within safe limits, some other devices could be sensitive to such emissions. If you notice other devices do not behave as expected when your sound processor is nearby, separate the devices.  Portable and mobil…

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Sky CI M90 Sound Processor CI-5295 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, USA +1 661 362 1400 AdvancedBionics.com 029-M798-A2 Rev 1 2019-12-16 SYMBOLS TABLE: Labeling symbols and their meanings: Date of Manufacture Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF Suitable temperature range for transport and storage See Instructions for Use Fragile Suitable relative humidity range for transport and storage Caution (refer to “Cautions & Warnings” section for further information) Dispose of in accordance with applicable national and local regulations MR Unsafe IPXX Ingress Protection Rating LIMITATIONS AND CONTRAINDICATIONS: There are no known limitations or contraindications for the Sky CI M90 sound processor. PRECAUTIONS, CAUTIONS, AND WARNINGS:  This device should be used only by the individual for whom it is prescribed.  CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) may cause bodily harm. If any parts are swallowed or inhaled, consult a physician or hospital immediately.  Ensure appropriate supervision when child is wearing the Sky CI M90 sound processor and accessories. Do not allow children to play with or leave them unattended with the sound processor or any of its accessories.  Power supplies and battery chargers should be operated in an open area to ensure adequate airflow. While no injury cases have resulted, components may become hot during normal use or a fault condition. If the device’s temperature results in discomfort or pain when touched, disconnect the power source and contact your local Advanced Bionics representative.  Do not use any other power supply with the sound processor or accessories unless it is supplied by Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement.  Do not use accessories when they are plugged into power sources such as wall outlets, or other power sources that are USB compatible (e.g. laptops).  Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes.  Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car).  Remove batteries from your sound processor when they are drained to prevent damage from possible leaking.  Do not dispose of batteries in fire.  High levels of static electricity may damage electronic components of your sound processor or implant. Care should be taken to avoid exposure of the system to static electricity.  Do not attempt to pair your sound processor to any accessories while driving or operating heavy machinery.  Do not stream audio to your sound processor while driving or operating heavy machinery.  Attenuating ambient sounds or adjusting environmental balance while streaming audio (either with the multifunction button or with the mobile application) may compromise situational awareness.  Use your sound processor for hands-free phone use only where permitted by law and only when you will not be distracted from the safe operation of your vehicle.  Do not use your Advanced Bionics wireless accessories when instructed not to use wireless electronic devices, such as on airplanes.  Remove your sound processor and headpiece before entering a room where an MRI scanner is located.  Remove your sound processor and consult your cochlear implant professional if uncomfortable sounds are heard or in case of discomfort, pain or skin irritation.  If the sound processor or accessories become unusually hot or warm, discontinue use immediately and contact Advanced Bionics or your cochlear implant professional.  It is important to have the correct magnet strength, so you do not experience discomfort or retention issues. If magnet strength is insufficient, the headpiece may fall off more than is acceptable. If magnet strength is excessive, you may experience irritation or discomfort. Consult your cochlear implant professional if there are any concerns regarding magnet strength. If deemed appropriate, an audiologist may change the strength of the magnet in the headpiece. Do not change magnet strength unless under the direction of a cochlear implant professional. If you experience any redness, irritation, or discomfort, discontinue use of the headpiece immediately and contact a cochlear implant professional. See the headpiece instructions for use for additional information regarding adjustment of headpiece magnet strength.  Store additional headpieces away from items with magnetic strips (e.g., credit cards, hotel room keys, etc.) as they may de-magnetize cards.  The digitally-coded, inductive transmission technology used in this device is extremely reliable and experiences virtually no interference from other devices. It should be noted, however, that when operating the device near a computer terminal or other strong electromagnetic field (e.g. RFID system), it may be necessary to be at least 24” (60 cm) away to ensure proper operation. If the Sky CI M90 sound processor does not respond to the implant device because of an unusual field disturbance, move away from the disturbing field.  The Sky CI M90 sound processors and accessories should be used in accordance with the electromagnetic compatibility information provided in the Guidance and Manufacturer’s Declaration section of this document.  Although electromagnetic emissions of your Sky CI M90 sound processor have been confirmed within safe limits, some other devices could be sensitive to such emissions. If you notice other devices do not behave as expected when your sound processor is nearby, separate the devices.  Portable and mobile radio frequency (RF) communications equipment, including radios and cellular phones, may affect sound quality of the Sky CI M90 sound processor and accessories; however,…

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This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics. Technical Construct File for AB Marvel CI Sound Processor Rev A Page 1 of 4 Technical Construction File for Advanced Bionics Marvel CI Sound Processor Contents 1.0 Product List 2 2.0 External Pictures 2 Technical Construct File for AB Marvel CI Sound Processor Rev A Page 2 of 4 D000019857 Rev. C 1.0 Product List Product Name Model Number Naída CI M90 CI-5293 Naída CI M30 CI-5294 Sky CI M90 CI-5295 2.0 External Pictures Naída CI M90, Naída CI M30 and Sky CI M90 External Pictures Note: All models share identical hardware and are identified once model specific firmware is installed. Top Right Side Technical Construct File for AB Marvel CI Sound Processor Rev A Page 3 of 4 Left Side Rear Front Bottom - Naída CI M90 Bottom - Naída CI M30 Technical Construct File for AB Marvel CI Sound Processor Rev A Page 4 of 4 Bottom - Sky CI M90

This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics. FCC ID Label and ID Label Location for AB Marvel CI Sound Processor Rev A Page 1 of 2 FCC Label and ID Label Location for Advanced Bionics Marvel CI Sound Processor Pursuant to §2.925 of 47 C.F.R., the Advanced Bionics Marvel CI sound processor, which is the object of this filling, shall bear a permanently affixed, readily visible label listing the information as specified in §2.925 and §15.19(a) of 47 C.F.R. Due to the specific use of this product, its external surface is in permanent contact with the skin behind the ear. Therefore, it is not appropriate to permanently affix a label on the outer surface of the device which is in contact with the skin in order to prevent any possible skin irritations. The only possible location where the FCC ID, the hardware identification number and the serial number of the device can be placed is the battery interface shown below. This surface is smaller than 15mm X 4mm. In this case the size of the FCC ID font size will be smaller than two points, which does not satisfy the requirements for the size of the label as defined in §2.925(f). This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics. FCC ID Label and ID Label Location for AB Marvel CI Sound Processor Rev A Page 2 of 2 According to §15.19(a)(5) of 47 C.F.R., the FCC ID will be placed in the Instruction for Use (IFU) document and on the device packing label for the sound processor. The certification statement placed in the sound processor IFU is as follows: This instrument is certified under:  FCC ID: 2AU6O-ABBTE2  IC: 25853-ABBTE2 This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Advanced Bionics may void the FCC authorization to operate this equipment. This Class B digital apparatus complies with Canadian ICES-003. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. This equipment complies with FCC and ISED radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device has been evaluated in compliance with portable exposure condition. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving antenna.  Increase the separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  Consult your cochlear implant professional or an experienced radio/TV technician for help.

C000047776 ECO 2020-02-25 Data Created Label Title LABEL, Naida CI M30 Sound Processor (sand beige) A REV 024-P819-A2 LABEL NO. This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Notes: 024-P737-031. USE LABEL STANDARD

C000047776 ECO 2020-02-25 Data Created Label Title LABEL, Sky CI M90 Sound Processor (sand beige) A REV 024-P802-A2 LABEL NO. This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Notes: 024-P737-031. USE LABEL STANDARD

C000047776 ECO 2020-02-25 Data Created Label Title LABEL, Naida CI M90 Sound Processor (sand beige) A REV 024-P813-A2 LABEL NO. This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Notes: 024-P737-031. USE LABEL STANDARD

This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics. Technical Construct File for AB Marvel CI Sound Processor Rev A Page 1 of 4 Technical Construction File for Advanced Bionics Marvel CI Sound Processor Contents 1.0 Product List 2 2.0 Internal Pictures 2 Technical Construct File for AB Marvel CI Sound Processor Rev A Page 2 of 4 D000019857 Rev. C 1.0 Product List Product Name Model Number Naída CI M90 CI-5293 Naída CI M30 CI-5294 Sky CI M90 CI-5295 2.0 Internal Pictures PCBA Top Layer Technical Construct File for AB Marvel CI Sound Processor Rev A Page 3 of 4 PCBA Bottom Layer Assembly Side Views Assembly Top Views Technical Construct File for AB Marvel CI Sound Processor Rev A Page 4 of 4 Antenna Top View Antenna Bottom View

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Report No: (NIE) 62758RAN.002 2020-03-05 Test report No: NIE: 62758RAN.002 Assessment report RF EXPOSURE REPORT ACCORDING TO FCC 47 CFR Part 2.1093 ISED RSS -102 Issue 5:2015 (*) Identification of item under evaluation AB Sound Processor with 4.2 (*) Trademark --- (*) Model and /or type reference Naída CI M90 (*) Derived model not tested Naída CI M30, Sky CI M90 Other identification of the product FCC ID: 2AU6O-ABBTE2 IC: 25853-ABBTE2 HW version: CI-5293 SW version: 067-0353; 1.0.2.0 (RC2). (*) Features BT Classic, BLE, DM, Flora Manufacturer ADVANCED BIONICS LLC 28515 Westinghouse PL, Valencia, CA 91355, USA Test method requested, standard FCC 47 CFR Part 2.1093. Radiofrequency radiation exposure evaluation: portable devices. ISED RSS-102 Issue 5 (2015-03) – Radio Frequency Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands) Summary IN COMPLIANCE Approved by (name / position & signature) Miguel Lacave Antennas Lab Manager Date of issue 2020-03-05 Report template No FAN24_02 (*) “Data provided by the client” DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Report No: (NIE) 62758RAN.002 Page 2 of 11 2020-03-05 Index Competences and guarantees .................................................................................................... 3 General conditions ...................................................................................................................... 3 Data provided by the client .......................................................................................................... 3 Identification of the client............................................................................................................. 4 Document history ........................................................................................................................ 4 General description of the device under evaluation ..................................................................... 5 Assessment summary ................................................................................................................. 5 Evaluation Results ...................................................................................................................... 6 Appendix A: FCC RF Exposure information ................................................................................ 7 FCC SAR test exclusion considerations for portable devices ................................................. 8 Appendix B: ISED RF Exposure information ............................................................................. 10 ISED SAR test exclusion considerations .............................................................................. 11 DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Report No: (NIE) 62758RAN.002 Page 3 of 11 2020-03-05 Competences and guarantees In order to assure the traceability to other national and international laboratories, DEKRA Testing and Certification, S.A.U. has a calibration and maintenance program for its measurement equipment. DEKRA Testing and Certification, S.A.U. guarantees the reliability of the data presented in this report, which is the result of the measurements and the tests performed to the item under test on the date and under the conditions stated on the report and, it is based on the knowledge and technical facilities available at DEKRA Testing and Certification, S.A.U. at the time…

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