Oticon Intent SmartCharger Instructions For Use
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Instructions for use SmartCharger miniRITE Oticon Intent™ 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 ext marked with a warning symbol must be read before using the device. T 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. Table of contents About Intended use Package contents Charger Temperature conditions Getting started Prepare charger Charge the hearing aids Daily use Charging time Charging the charger Power bank function Power and charge using other sources Caring for your charger Warnings General warnings More info Conditions of use Compliance statements Troubleshooting 4 5 6 7 8 10 12 14 16 18 19 20 24 28 32 Intended use Intended use The charger is intended to recharge the hearing aids that contain rechargeable batteries. The product is intended to be used together with the given hearing solution. 4 Indications for use There are no indications for use (diagnoses) for the charger itself. Intended user Person with hearing loss using a hearing aid and their caregivers. Hearing care professional responsible for adjusting the accessory. Intended user group Adults and children older than 36 months. Use environment Indoor and outdoor. Contraindications No contraindications. Clinical benefits See clinical benefits of the hearing aid. | About | Getting started | Daily use | Warnings | More info | Package contents The packaging box consists of the following elements: • Charger • Cable • Power plug (varies from country to country) 5 Charger What it is and does USB cable Insert in power plug Power cable Supply power 6 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 | About | Getting started | Daily use | Warnings | More info | Temperature conditions Temperature Charging condition Below +5°C (+41°F) No charging due to low temperature. +15°C to +35°C (+59°F to +95°F) Best charging condition. The charging of hearing aids can take up to 2 hours. +5°C to +15°C and +35°C to +40°C (+41°F to +59°F and +95°F to +104°F) Extended charging. The charging of hearing aids can take up to 6 hours. Above +40°C (+104°F) No charging due to high temperature. IMPORTANT NOTICE Do not expose the charger to temperatures below -25°C (-13°F) or above +70°C (+158°F). 7 Prepare charger Connect to power source 8 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. | About | Getting started | Daily use | Warnings | More info | The charger will turn ON automatically and begin charging the built-in power bank battery. 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 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. 10 | About | Getting started | Daily use | Warnings | More info | Charging status The hearing aid LED lights turn ON when the hearing aids are correctly placed in the charger. Hearing aid LED light charging status: Charging - Low battery Charging - At least 4 hours of use* Fully charged ORANGE pulse ORANGE GREEN * Expected use time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound environment, battery age and use of wireless accessories. 11 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. Charging time may vary depending on the remaining capacity of the battery and between the left/right-hand side hearing aid. If your hearing aid’s battery is completely drained, the normal charging and use time are:* Charge time (minute) 15 30 60 120 (full) Use time (hour) 4 8 16 20 * Expected use time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound environment, battery age and use of wireless accessories. 12 | About | Getting started | Daily use | Warnings | More info | When the battery in your hearing aids is fully charged, the charging process will stop automatically. 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 Ensure that your charger is powered or that the charger’s built-in battery is charged when the hearing aid is seated in the charging port. Otherwise your hearing aids 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 time* Power bank battery Power bank + hearing aids Up to 4 hours depending on charge level Up to 6 hours depending on charge level *Temperature conditions may affect the charging times. 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 pulse 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. 70 to 100% 40 to 70% less than 40% Battery too low for a full charging cycle ORANGE blink 16 GREEN | About | Getting started | Daily use | Warnings | More info | 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. 17 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 18 | About | Getting started | Daily use | Warnings | More info | 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 +15°C and +35°C (+59°F and +95°F). IMPORTANT NOTICE Ensure you remove the USB cable when you transport the charger. IMPORTANT NOTICE 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 other objects (e.g., cotton buds), and do not use water or cleaning fluids to clean the charging ports. 19 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. 20 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. | About | Getting started | Daily use | Warnings | More info | Keep away from chemicals Keep your charger away when applying 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 recharging batteries using a USB connector is determined by the external signal source. When connected to external equipment plugged into a power socket, this equipment must comply with IEC 62368-1 or equivalent safety standards. Connecting the charger to external equipment If you connect your hearing aid charger using a USB connector other than the one originally supplied with your charger, the USB connector must comply with IEC 62368-1 or equivalent safety standards. Beware of your surroundings Do not use your charger while driving or in other situations that require your full attention. 22 Potential 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 contains magnet and should be kept at least 15 centimeters (6 inches) away from any implanted medical device. Follow the guidelines from the manufacturer of your implanted medical device regarding their use with magnets. | About | Getting started | Daily use | Warnings | More info | 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. Connecting power adapter to power socket Only use the originally supplied power adapter (5.0V/1A) when connecting the charger to a power outlet. 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 Conditions of use Operating conditions Temperature: +5°C to +40°C (+41°F to +104°F) Humidity: 5% to 93%, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa Transportation and storage conditions Temperature and humidity shall not exceed the below limits for extended periods during transportation and storage: Temperature: -25°C to +70°C (-13°F to +158°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. 24 | About | Getting started | Daily use | Warnings | More info | This medical device complies with the Medical Device Regulation (EU) 2017/745. This device complies with part 15 of the FCC Rules. 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. SBO Hearing A/S Denmark Declaration of Conformity is available at the headquarters. Oticon A/S Kongebakken 9 DK-2765 Smørum Denmark www.oticon.global/doc Waste from electronic equipment must be handled according to local regulations. 25 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 Regulations 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. 26 | 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. 27 Compliance statements User information This device 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 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. However, there is no guarantee that interference will not occur in a particular installation. If this device 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 28 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 the manufacturer or an experienced radio/TV technician for help. | About | Getting started | Daily use | Warnings | More info | Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device. 29 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 30 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. | About | Getting started | Daily use | Warnings | More info | Troubleshooting 32 Symptom Possible causes The hearing aids do not turn ON after being removed from the charger The charger did not have enough time to turn the hearing aids ON before they were removed from the charger The hearing aids do not charge when placed in the charger The hearing aids are not properly inserted 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 | 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 Ensure the hearing aids are correctly inserted If the symptom persists, contact your hearing care professional Move the charger and hearing aid to a location with a temperature between +5°C and +40°C (+41°F and +104°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 Continues on next page 33 Troubleshooting Symptom Possible causes The hearing aid LED pulses ORANGE when hearing aid is placed in the charger but does not power ON when removed from the charger Battery is very low and insufficient to power ON hearing aid 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 34 System error | About | Getting started | Daily use | Warnings | More info | Solutions Insert the hearing aid into the charger to continue charging 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 +40°C (+41°F and +104°F) Reinsert the hearing aid into the charger Check the charging ports for foreign objects Contact your hearing care professional 35 272476US / 2023.10.23 / v1 < 9.0 mm > < 19 mm Placeholder for FSC logo > < > 8,15 mm < 15 mm > 0000272476000001 272476US / 2023.10.23 / v1 ">
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