Phonak iCube II User Manual

1. Welcome

The iCube II is specifically designed for use by audiologists. Please read this User Manual carefully to discover all the benefits you can gain from your iCube II.

For further information, visit the Phonak website at www.phonakpro.com.

Phonak: life is on

www.phonakpro.com

2. Description

The intended use of this device is the wireless transfer of fitting data from the PC to the client's hearing aids.

Components:

• Induction coil rear opening
• Induction coil connections
• Central indicator light (battery status and PC data transfer)
• Left LED indicator (data transfer)
• Right LED indicator (data transfer)
• On/Off switch
• Pairing button
• Mini USB charging port
• Wireless USB iCube II adapter

3. iCube II Accessories (Optional)

• USB cable, 3 m
• iCube II charger

Note: Content may vary by country.

4. Preliminary Operations

4.1 Power Adapter Setup

Choose the appropriate adapter for your country.

USA / UE Adapters:

1. Insert the rounded end of the adapter into the corresponding corner of the power supply.
2. Snap the lower end of the adapter into place to lock it.
3. To remove, pull back the tab on the power supply.
4. Then pull the adapter upwards to remove it.

Power Adapter Specifications:

• Output voltage: 5 V DC 1000 mA 5 W LPS
• Charger input voltage: 100-240 V AC 50/60Hz 0.2 A USB
• Cable specifications: length < 3 m

4.2 Battery Charging

Insert the mini USB plug into the iCube II and the power adapter into a power outlet.

If using the iCube II charger, install it as illustrated.

It is recommended to charge the iCube II every time it is not in use. This ensures it is sufficiently charged and ready for the next fitting session.

Note: The iCube II charger is available as an optional accessory.

Battery Notes:

• For the first charge, leave the iCube II charging for at least three hours (even if the central LED indicator turns green earlier).
• Recharging a fully depleted battery takes approximately 2 hours. It is safe to leave the iCube II connected for longer periods, even when not in use.
• The maximum performance of a new battery is reached after three full charge and discharge cycles.
• The iCube II battery can be charged several hundred times. If you notice a significant reduction in the iCube II's operating time, contact your local Phonak representative.

4.3 Operating Time

The fully charged iCube II can operate for up to approximately twelve hours of continuous fitting.

4.4 Powering the iCube II On and Off

Slide the switch as illustrated to turn the iCube II on or off.

• When the iCube II is fully functional, the central LED indicator flashes slowly.
• Turn off the iCube II when not in use and during charging. The central LED indicator stops flashing.

4.5 Phonak Target Fitting Software Requirements

Before using the iCube II, ensure that Phonak Target 4.0 or a later version is installed on the fitting PC.

5. Connecting the iCube II to the Computer

The iCube II is shipped with a pre-paired wireless USB adapter for quick and easy wireless connection setup with your fitting PC.

The iCube II can also be connected to any PC with Bluetooth functionality if a USB port is not available, or via a USB cable if a wireless connection cannot be established.

5.1 Wireless Connection

Automatic Connection:

To connect the iCube II to the fitting PC, ensure that the Phonak Target 4.0 application or a later version is installed. Insert the iCube II USB into a free USB port on the fitting PC.

Note: Ensure the USB adapter is inserted into a USB port on the fitting PC. Do not use a USB extension cable for connection.

Manual Pairing:

Turn on the iCube II and press the pairing button for 2 seconds to initiate pairing mode.

In pairing mode, all LED indicators flash rapidly. In Phonak Target, go to Tools, select Device pairing, and click Pairing in the iCube II USB adapter section.

Follow the assistant's steps for iCube II pairing. The assistant guides the user through the pairing process.

Note: Manual pairing is also necessary after resetting to factory settings.

5.2 USB Cable Connection

To connect the iCube II via USB cable, insert the mini USB connector into the iCube II and the other end into a free USB port on the fitting PC.

Phonak Target 4.0 or a more recent version detects the iCube II automatically, and you can then select it as the fitting device.

Note: If the computer does not have USB ports available, use the optional USB hub accessory.

6. Using the iCube II

Before using the iCube II, ensure the battery is sufficiently charged. If the central LED indicator is orange, the iCube II needs charging.

Ensure the iCube II is selected and shown as the fitting device in Phonak Target.

6.1 Wearing the iCube II

• Ensure both ends of the induction neckloop are securely inserted into the iCube II.
• Open the induction neckloop by disconnecting the connector in the center of the neckloop and position the iCube II around the client's neck.
• Close the induction neckloop to ensure proper functioning of the integrated antenna.

6.2 Detecting and Programming Hearing Aids

For wireless fitting, the assignment of the right/left hearing aid is done in Phonak Target. Ensure the iCube II is selected as the fitting device and click the Connect button.

Detected devices will be shown to assign (or reassign) each hearing aid to the desired side (left or right). Click Continue.

Follow the on-screen instructions to complete the detection.

6.3 Programming Hearing Aids on Your Desk

If you need to program hearing aids while they are not worn by the client (e.g., to prepare hearing aids before a fitting session), place them on a flat surface with the iCube II induction neckloop around them, as illustrated.

7. LED Indicators

The iCube II has 3 LED indicators that simply show the status of the battery, connection, and fitting.

• Central indicator solid orange: Charging
• Central indicator solid green: Charge complete
• Central indicator solid green for 2 sec: iCube II startup
• Central indicator flashes slowly 3 times: iCube II shutdown
• Central indicator flashes slowly: On, no active connection to fitting PC
• Central indicator flashes regularly: Connection active to fitting PC
• Right and central indicators flash rapidly: Right hearing aid programming
• Left and central indicators flash rapidly: Left hearing aid programming
• All indicators flash rapidly: Pairing mode activated
• All three indicators flash rapidly: iCube II firmware update

Note: The central LED indicator turns orange when the battery is running low. Ensure to charge the iCube II after the fitting session.

Note: Phonak Target displays a notification when a new firmware version for the iCube II is available.

• Central indicator solid red: Fault, refer to the troubleshooting section.

8. Troubleshooting

9. Support and Warranty

9.1 Local Warranty

For local warranty terms, contact the Phonak representative from whom the device was purchased.

9.2 International Warranty

Phonak offers a limited international warranty valid for one year from the date of purchase. This limited warranty covers defects in materials and workmanship. The warranty is valid only upon presentation of proof of purchase.

The international warranty does not in any way prejudice the legal rights according to local consumer sales regulations.

9.3 Warranty Limitations

This warranty does not cover damage due to improper use or maintenance, exposure to chemical agents, immersion in water, or undue stress. In case of damage caused by third parties or unauthorized service centers, all rights to claim the warranty are forfeited.

Serial number:

Date of purchase:

10. Compliance Information

Europe: Declaration of Conformity

Phonak AG hereby declares that this product complies with the essential requirements of Regulation (EU) 2017/745 on medical devices and Directive 2014/53/EU on radio equipment.

The full text of the EU Declaration of Conformity can be requested from the manufacturer or the local Phonak representative, whose address can be found on the page https://www.phonak.com/com/en/certificates.html (worldwide).

Australia/New Zealand:

Indicates compliance of a device with the Spectrum Management Regulations (RSM) and Australian Communications and Media Authority (ACMA) regulations for legal sale in Australia and New Zealand.

The R-NZ compliance label is for radio products supplied in the New Zealand market with compliance level A1.

Phonak iCube II is certified according to the following standards:

• USA
  Canada
• ID FCC: KWC-ICUBE2
  IC: 2262A-ICUBE2

The Phonak iCube II USB adapter is certified according to the following standards:

• USA
  Canada
• ID FCC: 079BT402
  IC: 11512A-BT403

Notice 1

This device complies with Part 15 of the FCC Rules and Industry Canada's RSS-210 standard. Operation is subject to two conditions: 1) this device may not cause harmful interference; 2) this device must accept any interference received, including interference that may cause undesired operation.

Notice 2

Changes or modifications to this device not expressly approved by Phonak may void the FCC authorization to use the device.

Notice 3

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 and Canadian standard ICES-003 of Industry Canada. These limits are designed to provide reasonable protection against harmful interference in residential installations. 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 causes 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 device and the receiver;
• Connect the device to an outlet on a circuit different from that to which the receiver is connected;
• Consult the dealer or an experienced radio/TV technician for assistance.

Notice 4

Compliance with the Japanese Radio Law and the Japanese Telecommunications Business Law. This device is guaranteed under the Japanese Radio Law (電波法) and the Japanese Telecommunications Business Law (電気通信事業法). This device must not be modified (otherwise the assigned designation number is no longer valid).

Emission standards:

• EN 60601-1-2:2015, IEC 60601-1-2:2014, EN 55011:2009+A1, CISPR11:2009/AMD1:2010, CISPR22:1997, CISPR32:2012, ISO 7637-2:2011, CISPR25:2016, EN 55025:2017

Immunity standards:

• EN 60601-1-2:2015, IEC 60601-1-2:2014, EN 61000-4-2:2009, IEC 61000-4-2:2008, EN 61000-4-3:2006+A1+A2, IEC 61000-4-3:2006+A1+A2, EN 61000-4-4:2012, IEC 61000-4-4:2012, EN 61000-4-5:2014, IEC 61000-4-5:2014, EN 61000-4-6:2014, IEC 61000-4-6:2013, EN 61000-4-8:2010, IEC 61000-4-8:2009, EN 61000-4-11:2004, IEC 61000-4-11:2004, IEC 60601-1 (§ 4.10.2):2005, ISO 7637-2:2011

Any serious incident that occurs in relation to the device must be reported to the manufacturer's representative and the competent authority of the country of residence. A serious incident is defined as any event that directly or indirectly led, could have led, or may lead to any of the following:

• death of a patient, user or other person
• serious temporary or permanent deterioration of the state of health of a patient, user or other person
• serious threat to public health.

To report an unexpected operation or event, contact the manufacturer or a representative.

Careful and continuous care of the iCube contributes to excellent performance and a long lifespan. To ensure a long lifespan, Phonak AG provides a minimum support period of five years after the product is withdrawn from the market.

For more information on functions, benefits, configuration, use, and maintenance or repair of your accessories, contact the manufacturer's representative. Further information is available in the product's technical data sheet.

For any information on the repair service of hearing aids or accessories, contact the manufacturer's representative.

Intended Use:

The intended use is to transfer fitting data from the fitting PC to the clients' hearing aids. Fitting data is transferred from the fitting PC to the iCube II via Bluetooth connection using a wireless USB Bluetooth adapter. The iCube II will convert the data into a 10.6 MHz wireless signal that is transferred to the hearing aids via their induction neckloop antenna. It can be used with any Phonak wireless hearing aid, from the Venture, Quest, Spice+ and Spice generations.

Target Population:

Audiologists who create individual fittings for Phonak hearing aids.

Indications:

Presence of hearing loss and therefore individual fitting of hearing aids.

Contraindications:

None.

Environment of Use:

The iCube II is suitable for the environment of a professional healthcare facility such as audiologist offices.

Antenna Information

• Antenna Type: External antenna with induction neckloop
• Operating Frequency: 10.6 MHz (wireless connection to hearing aids) 2.402-2.480 GHz / 79 Channels FHSS (Bluetooth)
• Occupied Bandwidth (99% of bandwidth): 500 kHz
• Modulation: 8DPSK (wireless connection to hearing aids) GFSK, Pi/4DQPSK, 8DPSK (Bluetooth)
• Magnetic field strength at 10 m: < -21 dBμA/m

11. Information and Symbol Descriptions

• CE Mark: With the CE symbol, Phonak AG confirms that this Phonak product meets the essential requirements of Regulation (EU) 2017/745 on medical devices, as well as the requirements of Directive 2014/53/EU on radio equipment.
• Symbol with person walking: This symbol indicates that the products described in these instructions for use meet the requirements for a Type B component in accordance with EN 60601-1. The surface of the device is defined as a Type B component.
• Symbol with 'i': This symbol indicates that it is important for the user to read and consider the information contained in this user manual.
• Symbol with exclamation mark: This symbol indicates that it is important for the user to pay attention to the warnings contained in these user manuals.
• Symbol with 'i' inside a circle: Important information for product management and safety.
• Thermometer symbol: Temperature for transport and storage: between -20° and +60° Celsius (between -4° and +140° Fahrenheit). Operating temperature: between 0° and 40° Celsius (between +32° and +104° Fahrenheit).
• Umbrella symbol: Keep dry.
• Percentage symbol: Humidity during transport and storage: <90% (non-condensing). Operating humidity: <95% (non-condensing).
• Barometer symbol: Atmospheric pressure: Transport, storage and operation: between 500 hPa and 1060 hPa.
• Symbol with a cross on a bin: The symbol with a cross on the waste bin indicates that this device must not be disposed of as normal household waste. Please return the old or unused device to the designated collection point for recycling of electronic equipment, or take it to the branch, which will ensure proper disposal. Proper disposal protects the environment and human health.
• Bluetooth® logo: The Bluetooth® graphic identity and logos are registered trademarks of Bluetooth SIG, Inc., and any use of such marks by Phonak is under license. Other trademarks and trade names belong to their respective owners.
• Japanese radio equipment certification mark.
• EC REP: Indicates the medical device manufacturer, as specified in EU Regulation 2017/745 (EU) on medical devices. Indicates the authorized representative in the European Community. The Authorized Representative in Europe is also the importer for the European Union.
• MD: The device is a medical device.

12. Important Safety Information

Warnings regarding hazards

• The following instructions apply only to users with implantable medical devices (e.g., pacemakers, defibrillators, etc.).
• Keep the wireless hearing aid or wireless accessory at least 15 cm away from the active implant. If interference is encountered, do not use the wireless hearing aids and contact the manufacturer of the active implant. Interference can also be caused by power lines, electrostatic discharges, airport metal detectors, etc.
• Keep magnetic elements (such as the battery tool, EasyPhone magnet, etc.) at least 15 cm away from the active implant.
• Keep this device out of the reach of children under 3 years of age, persons with mental disabilities, or domestic animals.
• Changes or modifications to the device are not permitted without the express authorization of Phonak.
• If you attempt to open the device, you are likely to damage it. If you encounter problems that cannot be resolved by following the troubleshooting guidance in this user manual, contact your Phonak representative.
• This product contains a non-replaceable built-in battery. Do not attempt to open the product or remove the battery, as this may result in personal injury and damage to the device.
• To avoid electric shock, use only accessories approved by Phonak AG.
• Improper use of the device and its connectors or cables as described in this user manual (e.g., wearing the USB cable around the neck) may cause injury.
• When operating machinery, ensure that no part becomes entangled in the machine.

For the charger, use only EN60950- or EN60601-1 certified equipment with an output power of 5 V DC, min. 500 mA.

Caution: electric shock. Do not insert the plug alone into electrical outlets.

• Do not use the device in explosive areas (mines or industrial areas with explosion risk, oxygen-rich environments, or areas where flammable anesthetics are handled) or in areas where electronic equipment is prohibited.
• Avoid using this equipment near or over other equipment, as it may cause a malfunction. If such use is necessary, both pieces of equipment must be kept under observation to verify their correct operation.
• The use of accessories, transducers, and cables other than those specified or supplied by the manufacturer of this equipment may increase electromagnetic emissions or reduce the electromagnetic immunity of this equipment and cause incorrect operation.
• Portable RF communication equipment (including antenna peripherals such as antenna cables and external antennas) and specified cables from the manufacturer should be used at a distance greater than 30 cm from any part of the iCube II. Otherwise, a deterioration in the performance of this equipment may occur.

Product Safety Information

• Protect the device from excessive humidity (bathroom, swimming pool), heat (radiators, car dashboard), or contact with skin when sweating.
• Do not drop the device. Dropping it on a hard surface may damage it.

• Do not disconnect the induction neckloop while the device is transmitting signals to the hearing aid.
• Protect the device's connectors, sockets, charging port, and power adapter from dirt and impurities.
• Never use a microwave oven or other heating devices to dry the device.
• The inductive transmission technology with digital coding used in the device is extremely reliable and practically free from interference from other devices. However, it should be noted that when using the acoustic system near a computer, large electronic installations, or other strong electromagnetic fields, it may be necessary to maintain a distance of at least 60 cm from the electromagnetic field to ensure proper operation.
• Keep the device at least 10 cm away from any type of magnet.
• Do not connect a USB cable exceeding 3 meters in length to the device.
• When not in use, turn off the device, keep the neckloop closed, and store it in a safe place.

Other important information

• If multiple devices are used in the same building, pay attention to the fact that their inductive fields may interfere with each other within a radius of 2 meters. This situation can also occur if the devices are used in different rooms.
• High-power electronic equipment, large electronic installations, and metal structures can significantly compromise and reduce the device's operating range.
• If hearing aids do not respond to the device due to unusual field disturbance, move away from the field causing the disturbance.

13. Care and Maintenance

Device Cleaning

For cleaning, use a lint-free cloth. Dry cleaning is preferred. If necessary, the surface can be cleaned with water and mild soap. However, the cloth must be damp and not soaked or dripping, to prevent moisture from penetrating the device.

Do not use aggressive substances such as solvents or paint thinners, as they can damage the surface.

Notes