Cochlear Baha 5 Power Sound Processor User Manual

Cochlear Baha 5 Power Sound Processor User Manual

Welcome

Congratulations on your choice of the Cochlear™ Baha® 5 Power Sound Processor. You are now ready to use Cochlear’s highly advanced bone conduction sound processor, featuring sophisticated signal processing and wireless technology.

This manual is full of tips and advice on how to best use and care for your Baha sound processor. By reading this manual and then keeping it handy for future reference, you will ensure that you get the most benefit out of your Baha sound processor.

Key to device

_ See figure 1

_

1. Visual indicator
2. Microphones
3. Battery compartment door
4. Tamper proof lock
5. Attachment point for the safety line
6. Volume rocker
7. Program button, Wireless audio streaming button
8. Plastic snap connector

Note on figures: The figures included on the cover correspond to information specific to this model of sound processor. Please reference the appropriate figure when reading. The images shown are not to scale.

Introduction

To ensure optimal performance, your hearing care professional will fit the sound processor to suit your needs. Be sure to discuss any questions or concerns that you may have regarding your hearing or use of this system with your hearing care professional.

Key to symbols

The following symbols will be used throughout this document. Please refer to the list below for explanations:

• “Caution” or “Caution, consult accompanying documents”

• Audible signal

• CE mark and Notified Body number

• Manufacturer

• Batch Code

• Medical device

• Catalogue number

• Serial Number

• Unique device identifier

• Keep dry

• Radio compliance certification for Korea

• Radio compliance certification for Japan

• ACMA symbol (Australian Communications and Media Authority) compliant

• Temperature limitation

• Interference risk

• Date of manufacture

• By prescription
  Rx Only

• Bluetooth®

• Refer to instructions/ booklet.

Note: Symbol is blue.

• Recyclable material

• Made for iPod, iPhone, iPad
  

• Waste of Electrical and Electronic Equipment

• Radio compliance certification for Brasil

On/off

_ See figure 2

_

1. To turn on your sound processor close the battery door completely.
2. To turn off your sound processor gently open the battery door until you feel the first “click”.

When your sound processor is turned off and then back on again, it will return to Program 1 and default volume level.

Status indicator

** See figure _3

_**

Visual indicators and beeps will alert you of changes to your sound processor. For a complete overview see the Visual indicators and beeps chart at the end of the section.

Change program/streaming

_ **See figure 4

**_

Your sound processor can be fitted with up to four programs suitable for different listening environments. The program button lets you choose from these pre-set programs and enable/disable wireless streaming.

• To change program press the program button located on the top of your sound processor.
• To activate audio wireless streaming press and hold the program button. Press the program button again to end wireless streaming and return to the previous program.

If you are a bilateral user, program changes you make to one device will automatically apply to the second device. This function can be enabled or disabled by your hearing care professional.

NOTE:
You can also change program and adjust the volume using the optional Cochlear Baha Remote Control or Cochlear Wireless Phone Clip or directly from iPhone, iPad or iPod touch (see MFi for more information).

Adjust volume

_ **See figure 5

**_

You can adjust the volume level of your sound processor using the volume rocker located on the side of the sound processor.

• To increase the volume, press the top of the volume rocker.
• To decrease the volume, press the bottom of the volume rocker.

Keylock

You can use the Keylock function to prevent inadvertent changes to your sound processor settings (such as program choice or volume level). This function can be enabled or disabled by your hearing care professional and is an important feature when the sound processor is being used by a child.

Wireless Accessories

Your sound processor is compatible with a range of Cochlear Wireless Accessories that can enhance your listening experience. Ask your hearing care professional to learn more about your options or visit www.cochlear.com.

Flight mode

_ **See figure 6

**_

Wireless functionality must be deactivated when boarding a flight.

1. To turn on Flight mode first turn off the sound processor by opening the battery door.
2. Press and hold the program button and at the same time, close the battery door.

To turn off Flight mode simply turn the sound processor off and back on again.

Made for iPhone (MFi)

Your sound processor is a Made for iPhone (MFi) hearing device. This allows you to control your sound processor and stream audio directly from iPhone, iPad or iPod touch. For full compatibility details and more information visit www.cochlear.com.

1. To pair your sound processor turn on Bluetooth on your iPhone, iPad or iPod touch.
2. Turn off your sound processor and go to Settings > General > Accessibility on your iPhone, iPad or iPod touch.
3. Turn on your sound processor and select Hearing Aids in the Accessibility menu.
4. When displayed, tap on the sound processor name under “Devices” and press Pair when prompted.

Talk on the phone

_ **See figure 7

**_

For best results, use a Cochlear Wireless Phone Clip or stream the conversation directly from your iPhone. When using a normal handheld phone, place the receiver near the microphone inlet of your sound processor instead of near your ear. Ensure the receiver does not touch the sound processor as this may result in feedback.

Replace the battery

See figure 8

The visual indicators and beeps will alert you when there is approximately one hour of battery power remaining. At this time you may experience lower amplification. If the battery runs down completely the sound processor will stop working. Use one of the batteries (zinc-air, non rechargeable) included in the sound processor kit as a replacement. The batteries included in the kit reflect Cochlear’s latest recommendations. Contact your hearing care professional for additional batteries.

1. To replace the battery hold the sound processor with the front facing up.
2. Gently open the battery door until it is completely open.
3. Remove the old battery and dispose of it according to local regulations.
4. Remove the new battery from the packet and peel away the sticker on the + side.
5. Insert the battery into the battery compartment with the + side facing up.
6. Gently close the battery door.

Tips

• To maximise battery life, switch off the sound processor when it is not in use.
• Battery life decreases as soon as the battery is exposed to air (when the plastic strip is removed) so be sure to only remove the plastic strip directly prior to use.
• Battery life depends on daily use, volume levels, wireless streaming, sound environment, program setting, and battery strength.
• If a battery leaks, replace it immediately.

Lock and unlock the battery door

_ See figure 9

_

You can lock the battery door to prevent it from opening accidentally (tamper- proof). This is particularly useful to prevent children, and other recipients in need of supervision, from accidentally accessing the battery.

1. To lock the battery door, close the battery door completely and place the Locking tool into the battery door slot. Slide the locking pin up into place.
2. To unlock the battery door, place the Locking tool into the battery door slot. Slide the locking pin down into place.

WARNING:
Batteries can be harmful if swallowed, put in the nose or in the ear. Be sure to keep your batteries out of reach of small children and other recipients in need of supervision. Before use, verify that the battery door is properly locked. In the event a battery is accidentally swallowed, or stuck in the nose or in the ear, seek immediate medical attention at the nearest emergency centre.

Attach the Safety line

_ See figure 10

_

To use the Safety line, simply attach it to the sound processor and clip it on to your shirt or jacket.
Cochlear recommends connecting the Safety line when engaging in physical activities. Children should use the Safety line at all times.

General care

Your sound processor is a delicate electronic device. Follow these guidelines to keep it in proper working order:

• Turn off and store the sound processor free from dust and dirt.
• Remove the battery when storing the sound processor for long periods.
• Avoid exposing your sound processor to extreme temperatures.
• Remove your sound processor before applying hair conditioners, mosquito repellent or similar products.
• Secure your sound processor with a Safety line during physical activities. If the physical activity involves contact, Cochlear recommends removing your sound processor.
• Your sound processor is not waterproof. Do not use it when swimming and avoid exposing it to heavy rain
• For cleaning your sound processor and snap coupling use the Baha sound processor Cleaning kit.

If the sound processor becomes very wet

1. Immediately open the battery door and remove the battery.
2. Put your sound processor in a container with drying capsules such as a Dri-Aid Kit. Leave it to dry out overnight. Drying kits are available from most hearing care professionals.

Feedback (whistling) problems

_ See figure 11

_

• Check to ensure that your sound processor is not in contact with items such as glasses or a hat or in contact with your head or ear.
• Check that the battery compartment is closed.
• Check that there is no external damage to the sound processor.

Contact you hearing care professional if problems persist.

Share the experience

_See figure 12

_

Family members and friends can “share the experience” of bone conduction hearing using the test rod.

1. Turn on your sound processor and attach it on the test rod by tilting it into place.
2. Hold the test rod against the skull bone behind an ear. Plug both ears and listen.

Visual indicators

Your hearing care professional can set up your processor to show the following light indications. All light flashes are orange.

General

Light|

What it means

Steady light for 10 seconds| Start up.

4 x dual flashes| Start up in Flight Mode.

1-4 flashes| Change program. Number of flashes indicates the number of the current program.

1 quick flash| Volume level increased/decreased by one step.

1 long flash| Volume limit reached.

Rapid flashes for 2.5 seconds| Low battery warning.

Wireless

Light|

What it means

1 long flash followed by 1 short flash| Wireless streaming activated.

1 long flash followed by 1 short flash| Change from one wireless accessory to another.

1-4 flashes| End wireless streaming due to low battery voltage and return to program. Number of short flashes indicates the number of the current program.

Beeps
Your hearing care professional can set up your processor so you can hear the following beeps. The beeps are only audible to the recipient.

General

Beeps|

What it means

10 beeps| Start up.

10 x dual beeps| Start up in Flight Mode.

1-4 beeps| Change program. Number of beeps indicates the number of the current program.

1 beep| Volume level increased/ decreased by one step.

1 long beep| Volume limit reached.

4 beeps 2 times| Low battery warning.

Wireless

Beeps|

What it means

Ripple tone in upward melody| Wireless Accessory pairing confirmation.

Ripple tone upward melody| Wireless streaming activated.

2 × ripple tone downward melody| End wireless streaming due to low battery voltage and return to program.

6 beeps followed by ripple tone upward melody (about 20 seconds after pairing)| MFi pairing confirmation.

Ripple tone upward melody| Change from one wireless accessory to another

General advice

A sound processor will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.

• Infrequent use of a sound processor may not enable a user to attain full benefit from it.
• The use of a sound processor is only part of hearing rehabilitation and may need to be supplemented by auditory and lip reading training.

Serious incidents

Serious incidents are rare, any serious incident in relation to your device should be reported to your Cochlear representative and to the medical device authority in your country, if available.

Warnings

• Contains small parts that may present a choking or suffocation hazard.
• Adult supervision is recommended when the user is a child.
• The sound processor and other external accessories should never be brought into a room with an MRI machine, as damage to the sound processor or the MRI equipment could occur.
• The sound processor must be removed before entering a room where an MRI scanner is located.

Advice

• The sound processor is a digital, electrical, medical instrument designed for specific use. As such, due care and attention must be exercised by the user at all times.

• The sound processor is not waterproof!

• Never wear it in heavy rain, in the bath or shower!

• Do not expose the sound processor to extreme temperatures. It is designed to operate within the temperature ranges +5 °C (+41 °F) to +40 °C (+104 °F). In particular, battery performance deteriorates in temperatures under +5 °C.

• The processor should not be subjected, at any time, to temperatures below -10 °C (+14 °F) or above +55 °C (+131 °F).

• The sound processor should be stored at temperature ranges +15 °C (+59 °F) to +30 °C (+86 °F).

• This product is not suitable for use in flammable and/or explosive environments.

• If you are to undergo an MRI (Magnetic Resonance Imaging) procedure, refer to the MRI Reference Card included in the document pack.

• Portable and mobile RF (radio frequency) communications equipment can affect the performance of your sound processor.

• The sound processor is suitable for use in electromagnetic environments with power frequency magnetic fields of typical commercial or hospital levels.

• Interference may occur in the vicinity of equipment with the symbol to the right.

• Dispose of batteries and electronic items in accordance with your local regulations.

• Discard your device as electronic waste according to local regulations.

• When the wireless function is activated, the sound processor uses low-powered digitally coded transmissions in order to communicate with other wireless devices. Although unlikely, nearby electronic devices may be affected. In that case, move the sound processor away from the affected electronic device.

• When using wireless functionality and the sound processor is affected by electromagnetic interference, move away from the cause of this interference.

• Be sure to deactivate wireless functionality when boarding flights.

• Turn off your wireless functionality by using the flight mode in areas where radio frequency emission is prohibited.

• Cochlear Baha wireless devices include an RF transmitter that operates in the range of 2.4 GHz–2.48 GHz.

• For wireless functionality, only use Cochlear Wireless accessories. For further guidance regarding e.g.  pairing, please refer to the user guide of the relevant Cochlear Wireless accessory.

• No modification of this equipment is allowed.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of your Baha 5 Power, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• Use of accessories, transducers and cables other than those specified or provided by Cochlear could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

CT scanners and diathermy systems

Potential disruption might occur due to electromagnetic emissions, f you are to undergo a CT scan (computed tomography) or have surgery where diathermy is used. If this occurs, you should turn off the sound processor.

Theft and metal detection systems and Radio Frequency ID (RFID) systems:

Devices such as airport metal detectors, commercial theft detection systems, and RFID scanners may produce strong electromagnetic fields. Some Baha users may experience a distorted sound sensation when passing through or near one of these devices. If this occurs, you should turn off the sound processor when in the vicinity of one of these devices. The materials used in the sound processor may activate metal detection systems. For this reason, you should carry the Security Control MRI Information Card with you at all times.

Electrostatic discharge

A discharge of static electricity can damage the electrical components of the sound processor or corrupt the program in the sound processor. If static electricity is present (e.g. when putting on or removing clothes over the head or getting out of a vehicle), you should touch something conductive (e.g. a metal door handle) before your sound processor contacts any object or person. Prior to engaging in activities that create extreme electrostatic discharge, such as playing on plastic slides, the sound processor should  be removed. If disruptions keep occurring,please contact your clinician to resolve the issue.

Sound processor type designations for models included in this User Manual are:

FCC ID: QZ3BAHA5POWER IC: 8039C-BAHA5POWER, IC model: Baha® 5 Power.

Statement:
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 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 the device does cause harmful interference to radio or television reception, 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 receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device into an outlet on a circuit different from the one in which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
• Changes or modifications can void the user´s authority to operate the device.

Intended use

The Cochlear Baha System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. The Baha 5 Power Sound Processor is intended to be used as part of the Cochlear Baha System to pick up surrounding sound and transfer it to the skull bone via a Baha Implant, Baha Softband or Baha SoundArc and can be used unilaterally or bilaterally.

Indications

The Baha System is indicated for patients with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD). The Baha 5 Power Sound Processor is indicated for patients with up to 55 dB SNHL.

Clinical benefit

Most recipients of a bone conduction hearing solution will experience improved hearing performance and quality of life compared to unaided listening. The fitting is to be done either at a hospital, by an audiologist, or in some countries, by a hearing care professional.

List of countries:

Not all products are available in all markets. Product availability is subject to regulatory approval in the respective markets.

The products are in compliance with the following regulatory requirements:

• In EU: the device conforms to the Essential Requirements according to Annex I of Council Directive 93/42/ EEC for medical devices (MDD) and essential requirements and other relevant provisions of Directive 2014/53/EU (RED).
• Other identified applicable international regulatory requirements in countries outside the EU and US. Please refer to local country requirements for these areas.
• In Canada the Sound Processor is certified under the following certification number: IC: 8039C-BAHA5POWER and model no.: IC model: Baha ® 5 Power.
• This device complies with Industry Canada licence-exempt RSS standard(s).
• Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Equipment includes RF transmitter.

NOTE:
The sound processor is suited for use in a home healthcare environment. The home healthcare environment includes locations such as homes, schools, churches, restaurants, hotels, cars, and airplanes, where equipment and systems are less likely to be administered by healthcare professionals.

Warranty

The warranty does not cover defects or damage arising from, associated with, or related to the use of this product with any non-Cochlear processing unit and/ or any non-Cochlear implant. See the “Cochlear Baha Global Limited Warranty card” for more details.

Contacting Customer Service

Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information. In Australia, Baha bone conduction implant systems are intended for the treatment of moderate to profound hearing loss.

Cochlear Baha 5 sound processors are compatible with Apple devices. For compatibility information, visit www.cochlear.com/compatibility.

Cochlear, Baha, 科利耳, コクレア, 코클리어, Hear now. And always, SmartSound, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB or Cochlear Limited (unless otherwise noted).

Apple, the Apple logo, iPhone, iPad and iPod are trademarks of Apple Inc., registered in the U.S. and other countries.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear Limited is under license.

© Cochlear Bone Anchored Solutions AB 2021. All rights reserved. 2021-10.

We strive to provide you with the best possible products and services. Your views and experiences with our products and services are important to us. If you have any comments you would like to share, please contact us.

Customer Service – Cochlear Americas
10350 Park Meadows Drive, Lone Tree
CO 80124, USA
Toll free (North America) 1800 523 5798
Tel: +1 303 790 9010,
Fax: +1 303 792 9025
E-mail: customer@cochlear.com

Customer Service – Cochlear Europe
6 Dashwood Lang Road, Bourne Business
Park, Addlestone, Surrey KT15 2HJ, United
Kingdom
Tel: +44 1932 26 3400,
Fax: +44 1932 26 3426
E-mail: info@cochlear.co.uk

Customer Service – Cochlear Asia Pacific
1 University Avenue, Macquarie University,
NSW 2109, Australia
Toll free (Australia) 1800 620 929
Toll free (New Zealand) 0800 444 819
Tel: +61 2 9428 6555,
Fax: +61 2 9428 6352 or
Toll free Fax 1800 005 215
E-mail: customerservice@cochlear.com.au

References

• Cochlear Americas | Hear Now And Always | Cochlear Implants
• Sound Processor and App Compatibility

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