Phonak BTE Charger Case Combi Charging Station User Guide

: June 3, 2024
: PHONAK

Phonak BTE Charger Case Combi Charging Station

Parts of the charger

Charger

Charger Combi BTE with optional Power Pack

Accessories

|
---|---

USB cable (< 1 m)

|

Power supply with wallplug adapter

Power supply and charger specification

Power supply output voltage	5 VDC +/-5%, current 1 A
Power supply input voltage	100-240 VAC, 50/60Hz, current 0,25 A
Charger input voltage	5 VDC +/-5%, current 150 mA
Charger output voltage	5 VDC +/-10%, current 100 mA
USB cable specifications	5 V min. 1 A, USB-A to micro-USB, maximum length 1 m

Preparing the charger

Connecting the power supply

a) Plug the larger end of the charging cable into the power supply.
b) Plug the smaller end into the USB port on the charger.
c) Plug the power supply into a power outlet.
d) The indicator light is green when the charger is connected to the power supply

Charging the hearing aids

| Low power: You will hear two beeps when the battery is low. You will have approximately 60 minutes before you have to charge the hearing aids (this can vary, depending on the hearing aid settings).
---|---
| Before using your hearing aids for the first time, it is recommended to charge them for 3 hours.
| The hearing aids must be dry before charging, see chapter 5.
| Please ensure to charge and use the hearing aids within operating temperature range: +5° to +40° Celsius (41° to 104° Fahrenheit).

Please refer to chapter 2 for how to set up the charger.

Insert the hearing aids into the charging slots. The hearing aids will automatically be switched off when inserted into the charger.

| Make sure the left and right hearing aid markings match the left (blue), right (red) indicators next to the charging slots.
---|---

The indicator light on the hearing aids will show the charging state of the battery until the hearing aids are fully charged. When fully charged the indicator light will remain on, i.e. solid green light.

The charging process will automatically stop when the batteries are fully charged, so the hearing aids can be safely left in the charger. It can take up to 3 hours to charge the hearing aids. The charger cover can be closed while charging.

Charging times

Indicator light of the hearing aid	Charging state	Approx. charging times
0 – 10%
11 – 80%	30 min (30%)

60 min (50%)
90 min (80%)
| 81 – 99%|
| 100%| 3 h

Remove the hearing aids from the charging slots by 1. tilting the hearing aids gently towards the back and 2. lifting them out of the charger.

| Do not hold the tubes to remove the hearing aids from the charger as this can damage the tubes.
---|---

The hearing aids switch on automatically when removed from the charger. The indicator light starts blinking. The solid green light indicates the hearing aids are ready.
To switch off the charger, remove the power supply from the power outlet.

| Turn off your hearing aids before inserting them in the disconnected charger to store them.
---|---
| Always close the lid when charging you hearing aids in a humid environment.
| If you unplug the charger while the hearing aids are charging inside, please make sure to turn them off to prevent discharge.

Using the optional Power Pack

Attach the Power Pack to the bottom of the charger and lock it.

Plug in the micro-USB and connect to an external power supply. The Power Pack and hearing aids will be charged at the same time. While connected to an external power supply, the Power Pack indicator light will show the current battery charge status of the Power Pack.

| Before using Power Pack for the first time, it is recommended to charge it for 3 hours.
---|---
| The Power Pack contains a built-in and nonremovable rechargeable lithium- polymer battery.

To check the remaining battery capacity of the Power Pack, press the battery check push button. The indicator lights will show the status.

| Please ensure to charge the Power Pack within operating temperature range: +5° to +40° Celsius (41° to 104° Fahrenheit)
---|---

If the device has been subject to storage and transportation conditions outside of the recommended use conditions, wait 15 minutes before starting the device
This charger is classified as IP22. This means that the charger is protected from vertically falling drops of water when the charger is tilted up to 15 degrees from the horizontal. IP22 is satisfied when the charger lid is closed.

Operation, transport and storage conditions

Please ensure to operate, transport and store the charging accessories according to the following conditions

| Operation| Transport| **storage***
---|---|---|---
Temperature Maximum range| +5° to + 40° Celsius (41° to 104° F)| -20° to + 60° Celsius (-4° to 140° F)| -20° to + 60° Celsius (-4° to 140° F)
Humidity Maximum range| 0% to 85%
(non-condensing)| 0% to 90%
(non-condensing)| 0% to 70%
(non-condensing)
Atmospheric pressure| 800 hPa to
1060 hPa| 500 hPa to
1060 hPa| 500 hPa to
1060 hPa

Power pack storage for a year or longer: to prevent damage to the battery cell, the maximum temperature range should be -20° to 25° Celsius and the battery cell should be discharged and recharged a minimum once every three months.

Care and maintenance

Expected service life

The charger has the expected service life of five years. The device is expected to remain safe for use for this duration

Commercial service period

Diligent and routine care of your charger contributes to outstanding performance and a long service life. To ensure a long service life, Sonova AG provides a minimum of a five year service period after phase out of the charger. Please use the following specifications as a guideline. Further information regarding product safety, see chapter 10.2.

General information

Please make sure that the charger is used and maintained as described in this user guide.

Daily

Make sure that charging slots are clean. Never use cleaning agents such as household detergents, soap, etc. for cleaning your charger.

Weekly

Remove dust or dirt from the charging slots.

| Always make sure that the hearing aids and charger are dry and clean before charging.
---|---
| Always make sure that the charger is disconnected from the power mains before cleaning.

Service and warranty

Local warranty

Please ask the hearing care professional where you purchased your charger about the terms of the local warranty.

International warranty

Sonova AG offers a one year limited international warranty, valid from the date of purchase. This limited warranty covers manufacturing and material defects in the charger. The warranty only comes into force if a proof of purchase is shown.
The international warranty does not affect any legal rights that you might have under applicable national legislation governing sale of consumer goods.

Warranty limitation

This warranty does not cover damage from improper handling or care, exposure to chemicals or undue stress. Damage caused by third parties or non-authorized service centers renders the warranty null and void. This warranty does not include any services performed by a hearing care professional in their office.

Compliance information

Declaration of Conformity

Hereby Sonova AG declares that this product meets the requirements of the EU Medical Devices Regulation 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.
NOTE: 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.
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 the dealer or an experienced radio/TV technician for help.
Please keep at least 20 cm separation distance between the charger and the human body during operation.

Compliance with emission and immunity standards

Emission standards	EN 60601-1-2

IEC 60601-1-2
EN 55011
CISPR11
CISPR32
CISPR25
EN 55025
Immunity standards| EN 60601-1-2
---|---
IEC 60601-1-2
EN 61000-4-2
IEC 61000-4-2
EN IEC 61000-4-3
IEC 61000-4-3
EN 61000-4-4
IEC 61000-4-4
EN 61000-4-5
IEC 61000-4-5
EN 61000-4-6
IEC 61000-4-6
EN 61000-4-8
IEC 61000-4-8
EN 61000-4-11
IEC 61000-4-11
IEC60601-1
ISO 7637-2

Information and description of symbols

| With the CE symbol, Sonova AG confirms that this product meets the requirements of the EU Medical Device Regulation 2017/745.
---|---
| Indicates the medical device manufacturer, as defined in EU Medical Device Regulation 2017/745
| Indicates the Authorized representative in the European Community. The EC REP is also the importer to the European Union.
| This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide.
| This symbol confers that the electromagnetic interference from the device is under limits approved by the US Federal Communications Commission
| This symbol indicates that it is important for the user to pay attention to the relevant warning notices in this user guide.
| Important information for handling and product safety.
| Indicates the manufacturer’s serial number so that a specific medical device can be identified.
| Indicates the manufacturer’s catalogue number so that the medical device can be identified.
| Indicates that the device is a medical device
| This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide.
| IP Rating = Ingress Protection Rating. IP22 rating indicates that the device is protected against solid foreign objects of 12,5 mm diameter and greater and is additionally protected against vertically falling water drops when enclosure tilted up to 15°.
| Temperature during transportation and storage:
–20° to +60° Celsius (–4° to +140° Fahrenheit).
| Humidity during storage: 0% to 70%, (non condensating)
| Atmospheric pressure during, transportation and storage: 500 hPa to 1060 hPa
| During transportation keep dry.
| The symbol with the crossed-out garbage bin is to make you aware that this charger may not be thrown away as normal household waste. Please dispose of old or unused charger, at waste disposal sites intended for electronic waste, or give your charger to your hearing care professional for disposal. Proper disposal protects the environment and health.
| Regulatory Compliance Mark (RCM) is a trade mark for electrical safety for equipment which is compliant with the EESS

Symbols applicable to the European power supply only

| Power supply with double isolation.
---|---
| Device designed for indoor use only.
| Safety isolating transformer, short circuit proof.

Troubleshooting

Problem	Causes
Charging does not start	Charger not connected to power supply

Hearing aids not inserted correctly into charger
| If the problem persists, contact your hearing care professional for assistance.
---|---

What to do
Connect the charger to power supply (chapter 2)
Insert hearing aids correctly into the charger (chapter 3)

Important safety information

Please read the relevant safety information and limitationsof-use information on the following pages before using your device.

Intended use

The charger is intended to charge the battery of the rechargeable hearing aids.
The Power Pack is intended to allow the compatible charger to recharge the battery of the rechargeable hearing aid, when no external power source is available.

Intended user

Intended for people with hearing loss using the compatible rechargeable hearing aids, their caregivers and the hearing care professional.

Intended patient population

The intended patient population is the user of the compatible hearing aids

Indication

Indications are not derived from the charging accessories but from the compatible hearing aids. General clinical indications for the use of hearing aids and Tinnitus feature are

Presence of a hearing loss
Uni- or bilatera
Conductive, sensorineural or mixed
Mild to profound
Presence of a chronic tinnitus (only applicable for devices which provide the Tinnitus feature)

Contra-indication

Contra-Indications are not derived from the charging accessories, but from the compatible hearing aids. General clinical contra-indications for the use of hearing aids and Tinnitus feature are

Hearing loss is not in the fitting range of the hearing aid (i.e. gain, frequency response)
Acute tinnitus
Deformity of the ear (i.e. closed ear canal; absence of the auricle)
Neural hearing loss

The primary criteria for the referral of a patient for a medical or other specialist opinion and / or treatment are as follows

Visible congenital or traumatic deformity of the ear;
History of active drainage from the ear in the previous 90 days;
History of sudden or rapidly progressive hearing loss in one or both ears within the previous 90 days
Acute or chronic dizziness;
Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz and 2000 Hz;
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal;
Pain or discomfort in the ear;
Abnormal appearance of the eardrum and ear canal such as:
- Inflammation of the external auditory canal
- Perforated eardrum
- Other abnormalities which the hearing care professional believes are of medical concern

The hearing care professional may decide that referral is not appropriate or in the best interests of the patient when the following applies

When there is sufficient evidence that the condition has been fully investigated by a medical specialist and any possible treatment has been provided;
The condition has not worsened or changed significantly since the previous investigation and / or treatment.

If the patient has given their informed and competent decision not to accept advice to seek a medical opinion, it is permissible to proceed to recommend appropriate hearing aid systems subject to the following considerations

The recommendation will not have any adverse effects on the patients’ health or general well-being;
The records confirm that all necessary considerations about the patient´s best interests have been made If legally required, the patient has signed a disclaimer to confirm that the referral advice has not been accepted and that it is an informed decision.

Clinical benefits

The charging accessories themselves do not provide a direct clinical benefit. An indirect clinical benefit is provided by enabling the rechargeable hearing aids to achieve their intended purpose.
Any serious incident that has occurred in relation to the charging accessories, should be reported to the manufacturer representative and the competent authority of the state of residence. The serious incident is described as any incident that directly or indirectly led, might have led or might lead to any of the following:
a) the death of a patient, user or other person
b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health
c) a serious public health threat
To report an unexpected operation or event, please contact the manufacturer or a representative.

Hazard warnings

| Do not use the charging accessories in explosive areas (mines or industrial areas with danger of explosions, oxygen rich environments or areas where flammable anesthetics are handled) The device is not ATEX certified.
---|---
| Keep the charging accessories out of reach of children, individuals with cognitive impairment and pets.
| Do not cover the whole charger while charging, e.g. with a cloth etc.
| Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
| The following is only applicable for persons with active implantable medical devices (i.e. pacemakers, defibrillators, etc.):
Keep the charging device at least 15 cm (6 inches) away from the active implant. If you experience any interference do not use the charging device and contact the manufacturer of the active implant. Please, note that the interferece can also be caused by powerlines, electrostatic discharge, airport metal detectors etc.
| Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
| Do not touch the contacts of the charger when powered
| Cables and cords wrapped around the neck may cause strangulation. Do not leave the device and its components unattended with children, individuals with cognitive impairment or pets
| The USB port of the charger is to be used for the described purpose only.
| For charger, use only IEC 60950-1*, IEC 62368-1 and/or IEC 60601-1 certified equipment with an output rating of 5 VDC. Min. 500 mA.
| Changes or modifications to the device that were not explicitly approved by Sonova AG are not permitted.
| Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the charger including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Information on product safety

| Protect your charging accessories from heat (never leave near a window or in the car). Never use a microwave or other heating devices to dry your charging accessories (due to risk of fire or explosion). Ask your hearing care professional about suitable drying methods.
---|---
| Do not place the charging accessories close to an induction cooking surface. Conductive structures inside the charging accessories could absorb inductive energy resulting in thermal destruction.
| Do not drop your charging accessories! Dropping onto a hard surface can damage your charging accessories.
| Charging accessories and power supply must be protected against shocks. If the charging accessories or power supply is damaged after a shock, they must not be used anymore.
| Do not use your charging accessories in areas where electronic equipment is prohibited.
| The hearing aids have to be dry before charging. Otherwise the charging reliability cannot be guaranteed.

Sonova Deutschland GmbH
Max-Eyth-Strasse 20
70736 Fellbach-Oeffingen
Germany

Australian Sponsor:
Sonova Australia Pty Ltd
12 Inglewood Place,
Norwest NSW 2153
Australia

Manufacturer:
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
Switzerland
www.phonak.com