Starkey ITC R and ITE R Hearing Aids User Manual

For charging ITC R & ITE R hearing aids

Your Custom Charger
User Manual

ITC R and ITE R Hearing Aids

Chargers included:
Starkey Custom Charger
Starkey Premium Custom Charger

Congrats!
The power to hear better is yours.

You’ve got a Custom Charger.
Smart choice.
Now you can get the most out of every day with the power to charge hearing aids you can count on.
After all – when you hear better, you live better.
Go ahead, have a read.
And get ready to experience the power of better hearing.

What’s included

Chargers covered in this user manual (select yours):

• Custom Charger

• Premium Custom Charger*

• Premium Custom Charger contains an on-board, rechargeable lithium-ion battery that is not removable.

Get to know your charger

• Meet your charger
• Use your charger
• Care for your charger

Meet your charger
Overview

1. Cleaning tool (included accessory)

2. Charging posts

3. Hearing aid indicator lights

4. Charger indicator lights
   (Premium Custom Charger only)

5. USB-C port

6. Power cord & adapter

Use your charger
It is recommended that you fully charge your hearing aids before using them.
To charge your hearing aids:

1. Plug your charger into an external power source, like a wall outlet.
   NOTE: On the Premium Custom Charger only, the back charger indicator lights will turn on for a few seconds when your charger is connected.
   Reminder – Custom Charger requires an external power source to charge hearing aids (e.g., a wall outlet).
   Premium Custom Charger lets you charge hearing aids cordless or plugged into an external power source (e.g., a wall outlet).

2. Place your hearing aids with the charging contacts facing down on the charging posts:
   • The right front hearing aid indicator light flashes green for two seconds when you insert the right hearing aid.
   • The left front hearing aid indicator light flashes green for two seconds when you insert the left hearing aid.
   (If the indicator lights do not turn on, see the Troubleshooting guide on p. 16.)
   • Your hearing aids will turn off and start charging. Charger can be open or closed during this.

3. Check the charging status of your hearing aids using the hearing aid indicator lights on the front of the charger:
   Front hearing aid indicator lights| Charging status
   ---|---
   | Charging
   | Fully charged
   | Fault state*

Your hearing aids will fully charge in 3.5 hours.

4. Take your hearing aids from the charger. They will turn on – ready to wear.

Before using your hearing aids for the first time, please see Your Custom Rechargeable Hearing Aid User Manual.

To charge your Premium Custom Charger:

1. Plug your charger into an external power source, like a wall outlet.
2. Check the charger indicator lights on the back of your charger to confirm the charging status of your charger.

Your charger will fully charge in under 3 hours.

Care for your charger

Cleaning tips
Keep your charger clean. This helps prevent damage from moisture and debris:

• Use the included cleaning tool to clear debris from the charging posts.
  This is where you insert your hearing aids for charging.

• Do not use water, cleaning fluids or solvents to clean the charging contacts. These can damage your charger.

• Try to keep the lid closed to prevent buildup of dust and debris.

Storage tips
Store your charger in a clean and dry area. This helps preserve the life of your charger and rechargeable hearing aid batteries:

• Choose a dresser or shelf in a room other than a bathroom or kitchen.
• Be sure the storage location is cool to avoid damage. Skip areas with extreme heat like a windowsill or hot car.
• It’s safe to leave your charger plugged in while wearing your hearing aids. But if you won’t be using it for an extended period (over a week), remove the power cord from your charger and/or external power source.

Troubleshooting guide

Problems with your charger? Try these tips. If issues continue, contact your hearing care professional.

Indicator lights do not turn on when  hearing aids are placed on the charging post.| Incorrect hearing aid orientation.| Reposition your hearing aids on the charging posts.
Custom Charger:
Not plugged into an external power source (e.g., a wall outlet).
Premium Custom Charger:
Depleted onboard battery| Custom Charger:
Connect the power supply cord to your  charger and plug into an external power source (e.g., a  wall outlet). The front  hearing aid indicator lights will turn on for  a few seconds to indicate connection to the power source.
If they do not, contact your hearing care professional.
Premium Custom Charger: Connect the  power cord to your charger and plug it into  the wall. The back charger indicator lights will turn on for a few seconds to  indicate connection to the power source.  If  they do not, contact your hearing care professional.
Red blinking hearing aid indicator lights.| Fault occurred.| Remove your hearing aids from the  charging posts, wait until the front hearing aid indicator  lights turn off, then re-insert.
If the red blinking persists, contact your  hearing care professional.
While charging hearing aids, no indicator  lights are lighting up.| Hearing aids have finished charging, Premium Custom Charger has moved to “power save” mode.| To trigger indicator lights, remove hearing aid from charging post for three seconds,  then re-insert it.
Hearing aid indicator lights will remain illuminated for 10 seconds.
Hearing aids whistling in the charger.| Incorrect hearing aid orientation.| Reposition your hearing aids in the  charging posts. Confirm that the charger indicator lights  begin to light up.
Charger is not plugged into an external  ower source or a working external power source.| Custom Charger:
Your charger may not be plugged into an  adequate external power source (e.g., a  wall outlet).
Test another wall outet or power supply to  ensure charger  is powered. If you do not  have access to an external power source,  push and hold your hearing aid’s user  control for 3 seconds to turn off.
Premium Custom Charger: Your charger’s  onboard battery  may be fully depleted.  Apply  external power to  your charger.
If you do not  have the power  cord, push  and  hold your hearing  aid’s user control  for 3 seconds to  turn it off.

Additional guidance

• Intended use
• FCC information
• Regulatory information

Intended Use
These hearing aid chargers are intended to charge lithium-ion rechargeable hearing aids, and are to be used with the patient’s selected hearing aid solution. For information about your hearing aid, please consult the hearing aid specific user manual.
Your charger is designed to operate in public and residential environments and is designed to comply with international Electromagnetic Compatibility emissions and immunity standards for medical devices. However, it is still possible that you may experience interference caused by power line disturbances, airport metal detectors, electromagnetic fields from other medical devices, radio signals and electrostatic discharges.
If you use other medical devices or wear implantable medical devices such as defibrillators or pacemakers and are concerned that your hearing instruments might cause interference with your medical device, please contact your physician or the manufacturer of  your medical device for information about the risk of disturbance.
Your charger should not be used during an MRI procedure or in a hyperbaric chamber or other oxygen-rich environments.
Your charger is classified as a Type B applied part under the IEC 60601-1 medical device standard.
Your charger is not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factories.

Your charger should be stored and transported within the temperature, humidity, and pressure anges of -10°C (14°F) to +45°C (113°F),10%-95% H, and 70 kPa – 106 kPa (equivalent to altitudes rom 1,200 ft (380 m) below sea level to 10,000 ft 3,000 m).

The charging temperature range is between 10°C (50°F) and 40°C (104°F) and between 10%-95% RH and 70 kPa-106 kPa.
CAUTION:

• If the product is hot, do not touch it until cool.

• If the product is not working, do not disassemble.
  Due to a shock hazard, contact the manufacturer and send the device in for repair.

• Keep out of reach from children. Do not ingest anything in the package, including desiccant, cleaning tool, etc.

• Any cords and AC adapters must be approved or listed  by a Nationally Recognized Testing Laboratory.

Clinical benefit
The charger itself does not provide a direct clinical benefit.
An indirect clinical benefit is provided by enabling the parent device (rechargeable hearing aids) to achieve their intended purpose.

We are required by regulations to provide the following warnings:
WARNING: Use of wireless charger directly next to other electronic equipment should be avoided because it could result in improper performance. If such use is necessary, note as to whether your hearing aids and the other equipment are operating normally.
WARNING: Use of accessories, components or replacement parts other than those provided by the manufacturer of your charger could result in increased electromagnetic emissions and decreased electromagnetic immunity and could result in degradation of performance.
WARNING: If Portable Radio Frequency communications equipment is used closer than 30 cm (12 inches) from your charger, degradation of the performance of your charger could result. If this occurs, move away from the communications equipment.
DO NOT OPEN CHARGER, NO USERSERVICEABLE PARTS INSIDE
The Custom Charger and Premium Custom Charger have a rating of IP 22 per IEC 60529. This means the unit is protected against solid objects over 12 mm, such as fingers and falling water drops, such as condensation.

Do not connect the charger to any devices not described in this user manual. The service life of both the Custom Charger and Premium Custom Charger is 3 years.
The Custom Charger and Premium Custom Charger have been tested to, and have passed, the following emissions and immunity tests:

• IEC 60601-1-2 radiated and conducted emissions requirements for a Group 1 Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affecting the power input source as stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as well as higher field levels from communications devices as stated in Table 9 of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of 30 A/m and proximity magnetic fields as stated in Table 11 of IEC 60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge.
• Immunity to Electrical fast transients on the power input at a level of +/- 2 kV at a 100 Hz repetition rate.
• Immunity to Surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances induced by RF fields on the power input as stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as stated in Table 6 of IEC 60601-1-2.

EU ADVERSE EVENT REPORTING
Any serious incident that has occurred in relation to your Starkey device should be reported to your local Starkey representative and the Competent Authority of the Member State in which you are established. A serious incident is defined as any malfunction,
deterioration in the characteristics and/or performance of the device, or inadequacy in the device user manual/labeling which could lead to the death or serious deterioration in the state of health of the user, OR could do so upon recurrence.

FCC information
These devices comply with part 15 of the FCC rules and with ISED Canada license-exempt RSS standards. 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 of the device.
NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment.
Such modifications could void the user’s authority to operate the equipment.

Regulatory information

Starkey Labs Canada Co.
2476 Argentia Road, Suite 301
Mississauga, ON L5N 6M1
www.starkeycanada.ca

Starkey Laboratories (Germany) GmbH
Weg beim Jäger 218-222
22335 Hamburg
Germany

Waste from electronic equipment must be handled according to local regulations

Consult user manual

Keep dry

Instructions for Disposal of Old Electronics
Starkey Laboratories, Inc. encourages, the EU requires, and your local community laws may require that your Premium Custom Charger be disposed of via your local electronics recycling/disposal process.
The instructions below are provided for the benefit of disposal/recycling personnel. Please include this manual when disposing of your charger.

FOR DISPOSAL/RECYCLING PERSONNEL ONLY
The Premium Custom Charger contains a lithium-ion polymer battery.
To remove the battery from the charger, follow one of two options:
Option 1

• Insert pry bars between the plastic and the USB-C metal housing (top and bottom)

• Pry apart to break the seam

• Clip battery wires and dispose battery
  Option 2

• Using the style groove as a guide, sever the plastic case on all 4 sides with a dremel blade, ultrasonic knife, hot wire, or band saw blade

• In each case, establish a limit guide so entrance over 3/32 inch beyond the outer shell is prevented

• Clip battery wires and dispose battery

Regulatory information

ISO 7010- WC01
| Refer to instruction manual/booklet| EC 60601-1, Reference no. Table D.2, Safety sign 10| ISO 7010-M002
| Collect Separately| DIRECTIVE 201 2/19/EU (VVEEE)| Annex IX
****| Class II equipment| IEC 60417
Reference no. Table D.1| Symbol 9 (IEC 60417- 5172)
| Direct current| IEC 60601-1 Reference no. Table D.1| IEC 60417-5031
| Recycling Symbol| European Parliament and Council
Directive 94/62/EC| Annex I-VII

Notes____.

Starkey is a trademark of Starkey Laboratories, Inc.
©2023 Starkey Laboratories, Inc. All Rights Reserved. 5/23 BKLT3164-01-EN-XX- CA
Patent: www.starkey.com/patents

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