Declarations of Conformity
Instructions for Bernafon models including: miniRITE T R, miniBTE T R, Alpha XT miniRITE T R, miniBTE T R, Alpha miniRITE T R, miniBTE T R, Entra B miniRITE T R, miniBTE T R, CROS miniRITE T R, ARTC100 Charging Station Plus, ARTC100, Charging Station Plus, Station Plus, Plus
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DocumentDocumentINSTRUCTIONS FOR USE Charger Plus miniRITE T R miniBTE T R Compatible with: Alpha XT miniRITE T R and miniBTE T R Alpha miniRITE T R and miniBTE T R Entra B miniRITE T R and miniBTE T R CROS miniRITE T R Introduction to this booklet This booklet guides you on how to use and maintain your new charger. Ensure you read this booklet carefully, including the Warnings section. This will help you get the most benefit from your charger. Warnings Text marked with a warning symbol must be read before using the device. If you have additional questions about the use of your charger, contact your hearing care professional. For your convenience, this booklet contains a navigation bar to help you navigate through the different sections. | About | Getting started | Daily use | Warnings | More info | IMPORTANT NOTICE For details on the functionality of your specific hearing aid solution, refer to your hearing aid's instructions for use. Intended use Intended use Indications for use Intended user Intended user group Use environment Contraindications Clinical benefits The charger is intended to recharge the hearing aids and CROS transmitter that contain rechargeable batteries. The product is intended to be used together with the given hearing solution. There are no indications for use (diagnoses) for the charger itself. Person with hearing loss using a hearing aid and their caregivers. Hearing care professional responsible for adjusting the accessory. Adults and children older than 36 months. Indoor and outdoor. No contraindications. See clinical benefits of the hearing aid. Table of contents About Charger 6 Temperature conditions 7 Getting started Prepare charger 8 Charge the hearing aids 10 Daily use Charging time 12 Charging the charger 14 Power bank function 16 Power and charge using other sources 17 Caring for your charger 18 Warnings General warnings 20 More info Troubleshooting 24 Conditions of use 28 Compliance statements 29 Warranty 35 Charger What it is and does USB cable Insert in power plug Power plug For power socket Charging ports For hearing aids when charging Battery indicator Displays charging status of the power bank/power bank battery levels 6 | About | Getting started | Daily use | Warnings | More info | Temperature conditions Temperature Below +5°C (+41°F) +10°C to +35°C (+50°F to +95°F) +5°C to +10°C and +35°C to +38°C (+41°F to 50°F and +95°F to +100°F) Above +38°C (+100°F) Charging condition No charging due to low temperature. Best charging condition. The charging of hearing aids can take up to 3.5 hours. Extended charging. The charging of hearing aids can take up to 5 hours. No charging due to high temperature. IMPORTANT NOTICE Do not expose the charger to temperatures below -20°C (-4°F) or above +60°C (140°F). 7 Prepare charger Connect to power source Step 1 Step 2 Step 3 Insert the USB plug into the power plug. Insert the other end of the USB cable into the back of the charger. Insert the power plug into a power socket. The charger will turn ON automatically and begin charging the built-in power bank battery. 8 | About | Getting started | Daily use | Warnings | More info | Charger is turned ON When the charger is connected to power, the charger's power bank charging status is shown. First use Charge the power bank's battery When you use your charger for the first time, it is important that you fully charge the charger's built-in battery. 9 Charge the hearing aids Place hearing aids in charger Charging status Place the hearing aids in the charging ports as shown in the picture and close the lid. Make sure that your hearing aids match the right and left color indicators on the charger's charging ports. The RED indicator is for the right side hearing aid. The BLUE indicator is for the left side hearing aid. The hearing aid LED lights turn ON when the hearing aids are correctly placed in the charger. Hearing aid LED light charging status: ORANGE = Charging GREEN = Fully charged 10 | About | Getting started | Daily use | Warnings | More info | Charging time Ensure you fully charge your hearing aids before first use and charge them every night. That ensures that you start your day with fully charged hearing aids. If your hearing aid's battery is completely drained, the normal charging time is: miniRITE T R miniBTE T R Fully charged 3 hours Fully charged 3.5 hours 50% charged 1 hour 40% charged 1 hour 25% charged 0.5 hours 20% charged 0.5 hours When the battery in your hearing aids is fully charged, the charging process will stop automatically. Charging time may vary depending on the remaining capacity of the battery and between the left/right-hand side hearing aid. 12 | About | Getting started | Daily use | Warnings | More info | The charger's lid serves as protection and storage for your hearing aids. During charging, when you open the lid, the LEDs in your hearing aids light up to indicate their charging status. Note If you have not used your hearing aid in a long time and you then try to recharge it, it may take up to 30 seconds before the hearing aid begins charging. For more information, see your hearing aid's instructions for use. IMPORTANT NOTICE Make sure that your charger is powered or that the charger's built-in battery is charged when the hearing aid or transmitter is seated in the charging port. Otherwise your hearing aids or transmitter will remain turned ON and continue using battery power. 13 Charging the charger Your charger contains a built-in lithium-ion rechargeable battery that doubles as a power bank. This lets you fully charge a pair of hearing aids a minimum of three times on a fully-charged power bank while you are on-the-go. When the charger is plugged into a power source · Your hearing aids and the charger's built-in battery are being charged. When the charger is unplugged from a power source · The charger enters Power bank mode, letting you charge your hearing aids when you do not have access to a power socket. Charging times Power bank battery Up to 4 hours depending on charge level Power bank + hearing aids Up to 8 hours depending on charge level Note It is recommended that you keep the lid closed at all times while charging your hearing aids. 14 | About | Getting started | Daily use | Warnings | More info | When the charger is connected to a power source, the LEDs on your charger indicate the charging status of the power bank. The LEDs turn OFF shortly after the power bank battery is fully charged. Charging (Battery too low to recharge the hearing aids) Charging Fully charged ORANGE blink ORANGE GREEN IMPORTANT NOTICE When charging, the charging indicators on your charger should be lit as described in this booklet. If the charging indicators are not lit as described, disconnect the charger and consult your hearing care professional. 15 Power bank function When the charger is disconnected from power, the LEDs on your charger indicate the charger's power bank battery level. You can check the remaining battery level by opening the charger's lid. Three full charging cycles of two hearing aids Two full charging cycles of two hearing aids One full charging cycle of two hearing aids Battery too low for a full charging cycle ORANGE blink GREEN Long-term storage Before you put away or store the charger for a prolonged period of time (more than 14 days), ensure you first fully charge the charger's power bank battery. This way the battery can be charged again. Note To protect the rechargeable battery, it is necessary that you fully charge the charger's power bank battery every 12 months, otherwise the rechargeable battery may need to be replaced. 16 | About | Getting started | Daily use | Warnings | More info | Power and charge using other sources You can power and charge the charger's battery from other sources than a power socket. This can be done by using the charger's USB cable. Ensure that the power source is USB 2.0 compliant, with a minimum of 500mA output. Examples of power sources: · Computer · Car IMPORTANT NOTICE When using a power socket, recharge the charger using the supplied original power supply (5.0V/1A) for the charger. 17 Caring for your charger Always ensure that the charger is dry and clean before use. Keep the charging ports clean from dust by using a dry cloth. Do not use water or cleaning fluids to clean the charging ports. Store your charger in a dry location, e.g., in the bedroom. Ensure you keep the charger in an environment with a temperature between +5°C and +38°C (+41°F and +100°F). IMPORTANT NOTICE Ensure you remove the USB cable when you transport the charger. IMPORTANT NOTICE To clean the charger, use a soft, dry cloth. The charger must never be washed or immersed in water or other liquids. 18 | About | Getting started | Daily use | Warnings | More info | General warnings For your personal safety and to ensure correct usage, you should familiarize yourself fully with the following general warnings before using your charger. Consult your hearing care professional if you experience unexpected operations or serious incidents with your charger during use or because of its use. Your hearing care professional will support you with issue handling and, if relevant, reporting to the manufacturer and/or the national authorities. Charging ports Do not place anything other than rechargeable hearing aids in the charging ports. Other items may short circuit the charger and result in burns. Choking hazards of swallowing small parts Keep all small parts (for example, hearing aids, earpieces, batteries, etc.) out of reach and sight of children and others who might swallow these items. If a battery, hearing aid or small part is swallowed, see a doctor immediately and contact the National Poison Center at 1-800-222-1222 or National Battery Ingestion Hotline at 1-800-498-8666. Keep away from extreme heat Never expose your charger to extreme heat. For example, do not leave your charger inside a parked car in the sun. Never use an external heating device to dry your charger. For example, do not dry your charger using a hair dryer or in an oven such as a microwave. 20 | About | Getting started | Daily use | Warnings | More info | Keep away from chemicals Keep your charger away from products that contain certain chemicals that can damage your charger. For example, cosmetics, hairspray, perfume, aftershave lotion, suntan lotion and insect repellent. Keep away from environments with risk of explosions Your charger is safe to use under normal usage conditions. The charger has not been tested for compliance with international standards concerning explosive environments. Do not use your charger in environments with risk of explosions such as mines, oil fields, oxygen rich environments or areas where flammable anesthetics are handled. Never attempt to replace rechargeable batteries Do not attempt to open your charger as it may damage the battery. Never attempt to replace the battery. If battery replacement is needed, return your device to the supplier. The warranty is void if there are signs of tampering. Beware of battery leakage Do not touch your charger if the battery appears to be leaking as the acids may cause skin irritation. If you have been in contact with battery acids, wipe it off using a wet cloth. If you experience skin irritation, consult your doctor. In the event of battery leakage contact your hearing care professional for further instructions. Continues on next page 21 General warnings Connection to external equipment The safety of the charger, when connected to external equipment with USB cable, is determined by the external signal source. When the charger is connected to external equipment which is plugged into a power socket, this equipment must comply with IEC 62368-1 or equivalent safety standards. Be aware of your surroundings Do not use your charger while driving or in other situations that require your full attention. Possible side effects The otherwise non-allergenic materials used in your charger may, in rare cases, cause a skin irritation or other side effects. If these conditions occur, consult your doctor. Transporting charger on aircraft Consult the airline for details about bringing your hearing aids charger onto an aircraft. Use with active medical implants If you have an active brain implant, contact the manufacturer of your implanted device for information about the use with a hearing aid. Your charger has been thoroughly tested and developed for human health according to international standards for human exposure (Specific Absorption Ratio SAR), induced electromagnetic power and voltages into the human body. 22 | About | Getting started | Daily use | Warnings | More info | The exposure values are well below international accepted safety limits for SAR, induced electromagnetic power and voltages into the human body defined in the standards for human health and coexistence with active medical implants, such as pacemakers and heart defibrillators. Charge charger every 12 months Ensure you charge the charger every 12 months to prevent potential battery damage during storage. Use of third-party accessories Only use accessories, cables or transducers (for example, microphones) supplied by the manufacturer. Non original accessories may result in reduced electromagnetic compatibility (EMC) of your charger. Remove your charger before certain medical procedures Remove your charger before medical procedures such as X-ray examinations, CT/ MR/PET scans, electrotherapy, surgery, etc. Your charger may be damaged if exposed to strong magnetic or electromagnetic fields. 23 Troubleshooting Symptom The hearing aids do not turn ON after being removed from the charger Possible causes The charger did not have enough time to turn the hearing aids ON before they were removed from the charger Two charger LEDs show ORANGE blinks The hearing aid or charger's temperature is too cold or too warm Three charger LEDs show ORANGE blinks System error The charger LEDs remain turned OFF when the charger is connected to power The charger is not charging 24 | About | Getting started | Daily use | Warnings | More info | Solutions Place the hearing aids in the charger ports and try again, or use the push button to turn the hearing aids ON manually Move the charger and hearing aid to a location with a temperature between +5°C and +38°C (+41°F and +100°F) Contact your hearing care professional Verify that the power plug is correctly connected Ensure that the power source delivers sufficient output for your charger, a minimum of 500mA. Continues on next page 25 Troubleshooting Symptom Possible causes The hearing aid LED blinks GREEN when the hearing aid is placed in the charger The hearing aid has not been in use for an extended period of time The charger is not turned ON The hearing aid LED remains turned OFF when the hearing aid is placed in the charger The hearing aid or charger's temperature is either too warm or too cold Charging is incomplete. The charger has stopped charging to protect the battery. The hearing aid is not correctly seated in the charger The hearing aid LED blinks ORANGE when the hearing aid is placed in the charger System error 26 | About | Getting started | Daily use | Warnings | More info | Solutions Depending on how depleted the battery in the hearing aid is, the hearing aid automatically resumes normal charging mode after a time frame of up to 10 minutes. Ensure you leave the hearing aid in the charger during this process. Verify that the charger power plug is correctly connected or the power bank has enough battery Move the charger and hearing aid to a location with a temperature between +5°C and +38°C (+41°F and +100°F) Reinsert the hearing aid into the charger. This completes the charging within approximately 15 minutes. Check the charging ports for foreign objects Contact your hearing care professional 27 Conditions of use Operating conditions Transportation and storage conditions Temperature: +5°C to +38°C (+41°F to +100°F) Humidity: 5% to 93%, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa Temperature and humidity shall not exceed the below limits for extended periods during transportation and storage: Temperature: -20°C to +60°C (-4°F to +140°F) Humidity: 5% to 93%, non-condensing For information about your hearing aid's conditions of use, see your hearing aid's instructions for use. 28 | About | Getting started | Daily use | Warnings | More info | Compliance statements This device complies with part 18 of the FCC Rules. Radiofrequency radiation exposure information This device complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This device should be installed and operated with minimum distance of 20 centimeters / 8 inches between the device and your body. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Use of other accessories not verified by the manufacturer may not ensure compliance with FCC RF exposure guidelines. User information This device has been tested and found to comply with the limits pursuant to part 18 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device 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. 29 However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to other electronic equipment, which can be determined by turning the device 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 equipment · Increase the separation between the equipment Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the device. 30 | About | Getting started | Daily use | Warnings | More info | This medical device complies with the Medical Device Regulation (EU) 2017/745. The device is classified as CISPR 11 group 2 class B equipment. This means that the device is using locally generated radio-frequency energy which is used for wireless power transfer (WPT) and, that the device is suitable for use in residential environments. Declaration of Conformity is available at the headquarters. Bernafon Kongebakken 9 DK-2765 Smørum Denmark www.bernafon.com/doc SBO Hearing A/S Denmark Waste from electronic equipment must be handled according to local regulations. 31 Description of symbols accompanying the product Warnings Text marked with a warning symbol must be read before using the device. Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Regulation 2017/745. CE mark The device complies with all required EU regulations and directives. Electronic waste (WEEE) Recycle hearing aids, accessories or batteries according to local regulations. Hearing aid users can also return electronic waste to their hearing care professional for disposal. Electronic equipment covered by Directive 2012/19/EU on waste and electrical equipment (WEEE). Regulatory Compliance Mark (RCM) The device complies with electrical safety, EMC and radio spectrum requirements for devices supplied to the Australian or New Zealand markets. Keep dry Indicates a medical device that needs to be protected from moisture. Catalog number Indicates the manufacturer's catalog number so that the medical device can be identified. 32 | About | Getting started | Daily use | Warnings | More info | Description of symbols accompanying the product Serial number Indicates the manufacturer's serial number so that a specific medical device can be identified. Medical Device The device is a medical device. Nature of supply voltage Indicates that the nature of the device's power supply voltage shall be DC (direct current). Battery recycling symbol Li-ion Battery recycling symbol. Temperature limit Indicates the temperature limits to which the medical device can be safely exposed. Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed. FW Firmware version used in the device. Unique device identifier Indicates a carrier that contains unique device identifier information. 33 International warranty Your device is covered by an international warranty issued by the manufacturer. This international warranty covers manufacturing and material defects in the device itself, but not in accessories such as batteries, tubing, speakers, earpieces and filters, etc. Problems arising from improper/incorrect handling or care, excessive use, accidents, repairs made by an unauthorized party, exposure to corrosive conditions, physical changes in your ear, damage due to foreign objects entering the device, or incorrect adjustments are NOT covered by the international warranty and may void it. The above international warranty does not affect any legal rights that you might have under applicable national legislation governing the sale of consumer goods in the country where you have bought your device. Your hearing care professional may also have issued a warranty that goes beyond the clauses of this international warranty. Please consult him/her for further information. If you need service Take your device to your hearing care professional, who may be able to sort out minor problems and adjustments immediately. Your hearing care professional may charge a fee for their services. 34 | About | Getting started | Daily use | Warnings | More info | Warranty Certificate Name of owner: _______________________________________________________ Hearing care professional:_______________________________________________ Hearing care professional's address: _______________________________________ Hearing care professional's phone: ________________________________________ Purchase date: ________________________________________________________ Warranty period: _______________ Month: ________________________________ Model: _______________________ Serial no.: ______________________________ 35 281904US / 2025.01.21 / v1 < > 8,15 mm < 21 mm > Placeholder for FSC logo < 15 mm > > 9.0 mm < 0000281904000001 281904US / 2025.01.21 / v1