Ceretone ELIX K1V MINI User manual

USER
MANUAL
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ceretone.co
Please read this user manual
thoroughly and completely
before using the product.
ELIX K1V MINI
v 1.0

Sound is a crucial component in the world we
live in. We perceive various things in the world
through sound every day. Losing your hearing
can hinder your ability to communicate with
your loved ones or even just the ability to get by
with your day-to-day tasks. We're here to help
you reconnect and take back control of your life
with the ELIX K1V hearing aids.
Thank you for choosing Ceretone.
Welcome
Before you can begin your journey back to better hearing,
please set some aside some time to read this manual carefully
prior to operating your hearing aids.

Contents
What is Hearing Loss?
What is a Hearing Aid
Notice
Intended Use
Warning & Safety Use
Do Not Use If
Matters Needing Attention
Accessory Kit
How to Use Your Device
Turn On & Off
Fault Self-Check Tables
Charging
Wear & Removal
Amplification Levels
Maintenance & Cleaning
Hearing Aids Care
Charging Case Care
Service & Repair
Using Your Hearing Aids
Tips For Better Communication
Troubleshooting
Technical Specification
Maintenance, Storage & Disposal
FDA Requirements
Warranty
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2
3
3
4
7
8
9
10
14
24
25
26
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11
12
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[Extracted from the literature of World Health Organization
Prevention of Blindness and Deafness (PBD) program.
Prevention of Deafness and Hearing Impaired Grades of
Hearing Impairment]
A speech frequency pure tone average
(average hearing thresholds at 0.5, 1, 2, and
4 kHz) of greater than 25 dB hearing level
(HL) in both ears was defined as hearing
loss per the World Health Organization’s
criteria, and this is the level at which hearing
loss begins to impair communication in
daily life.
What is Hearing Loss?
1

A hearing aid is a small electronic device
that you wear in or behind your ear. It
amplifies environmental sounds such as
voices or activity so that a person with
hearing loss can listen, communicate, and
participate more fully in daily activities, as
well as help people hear better in both
quiet and noisy situations.
What is a Hearing Aid?
2

❈ This hearing aid is only to be used to help people improve
their hearing ability.
❈ This device is only intended for the purpose described in
these instructions of use.
❈ The manufacturer is not liable for damage resulting from
improper or careless use and does not assume responsibility
for personal injury or property damage sustained by or
through the use of this product.
❈ This device is an amplifying device and is not a therapeutic
medical product.
❈ This device can neither prevent nor alleviate organic
hearing loss.
❈ The hearing aid can be used in indoor and outdoor
environments. Any patients needing hearing compensation, as
determined by a doctor, can use these hearing aids but the
patients must be 18 years old or older.
❈ For the patients with skin sensitive to silicone material, the
product may cause ear canal pruritus.
❈ First use may cause ear canal to appear temporarily
maladjustment, such as slight pain.
Notice
I. INTENDED USE
3

Notice
4
❈ The hearing aid can not be used by infants under 36
months old.
❈ In the case of discomfort and/or pain, please stop using
this device immediately and contact your doctor.
❈ Remove devices prior to any type of X-ray, MRI, or CT scan.
❈ This device is NOT recommended for use by those
suffering from Tympanitis or Ear Pyogenesis.
❈ This device is unsuitable for and should NOT be used in
the following situations: Patients with chronic suppurative
otitis media (CSOM), congenital ear atresia, or any type of ear
discharge
❈ This hearing aid can only be used for compensating
patients with hearing impairment, it does not have hearing
therapeutic value.
❈ NOT to be used at max volume; a sustained period may
cause discomfort or injury.
❈ Keep small parts (hearing instrument, ear domes, battery
or other detachable parts) that can be swallowed out of
children’s reach.
❈ Dropping, immersing in liquid, exposure to strong
electromagnetic fields or excessive heat will damage the
hearing aids.
II. WARNING & SAFETY USE

Notice
❈ Do not use the product in a potentially explosive or dangerous
environment.
❈ If parts become stuck in the ear canal, seek medical
assistance - do not attempt to remove them by yourself.
❈ This device uses an internal rechargeable battery that cannot
be changed by the user. DO NOT attempt to open or remove the
internal batteries as damage or injury can result and WILL VOID
the warranty
❈ Do not use at high volume for extended periods of time - ear
injury can result. Special care must be taken because this hearing
aid is a high-output type.
❈ If you experience any pain or strong discomfort using the
devices, remove and consult a doctor.
❈ Routine maintenance to keep the device clean is required.
Ensure that ear tips and sound collecting holes are free of debris
and moisture at all times.
❈ Avoid shocks or dropping the product.
❈ Do not store or use the product in environments of high
humidity or temperature (such as a sauna room), to avoid damage
II. WARNING & SAFETY USE
5

Notice
❈ Keep the devices away from small children and pets. Injury or damage
may result.
❈ Do not set volumes too high. Listening with high-output devices for
extended periods at high volume levels can cause further hearing
damage.
❈ Do not share your hearing aids with others. Using a hearing aid
configured for someone else can result in hearing damage or injury.
❈ Monitor for any unusual skin reaction. In some instances, wearing a
hearing aid can cause an allergic reaction leading to itchiness or rashes.
If you notice any allergic reaction (itchiness, swelling, or rash), stop
wearing the hearing aids and consult a medical specialist.
❈ Do not touch the hearing aids to any type of magnet or magnetized
object. Your hearing aids are delicate electronic instruments and may be
damaged by contact with strong magnetic fields.
❈ Do not touch the inside. The inside of the hearing aid contains many
delicate parts that are precision adjusted. Never pry the inside of the
hearing aid with a needle or similar object.
❈ Do not attempt to open or repair the devices yourself. Damage can
result and will void the warranty.
❈ Do not store your devices in hot/humid locations. You should never
leave your hearing aids near heating appliances or in direct sunlight. You
should also avoid humid locations such as a bathroom or near a
humidifier.
❈ Do not leave your hearing aids in the car as inside temperatures can
reach dangerous levels which could damage the devices.
II. WARNING & SAFETY USE
6

❈ Do not use the hearing aids together with a cell phone earpiece
directly - excessive noise and distortion may result.
❈ Keep small parts (hearing instrument, ear domes, battery or other
detachable parts) that can be swallowed out of children’s reach.
❈ Dropping, immersing in liquid, exposure to strong electromagnetic
fields or excessive heat will damage the hearing aids.
Please contact the MANUFACTURER:
❈ For assistance, if needed, in setting up, using or maintaining
your devices or
❈ To report any unexpected operation or events.
Notice
II. WARNING & SAFETY USE
7
1) Congenital atresia of external ear or deformity of any part of the ear
canal (external auditory meatus) or a large amount of foreign bodies in
external auditory meatus
2) Deafness is unstable, and the degree of hearing loss often fluctuates
3) Persistent headaches, dizziness, earaches, tinnitus or other symptoms
that are not suitable for adaptation
4) Sudden onset of hearing loss within the past 3 months; rapid
progressive deafness; unilateral hearing loss or other acute ear disease;
5) Effusion (secretions/discharge) in the ear and/or frequent purulence
(pus)
6) Central deafness (central nervous system) or non-organic deafness
7) Patients with acute otitis externa and tympanitis
8) Patients with acute and chronic suppurative otitis media (in the period
of purulent infection)
9) Patients who are allergic to the materials of this product
III. DO NOT USE IF ANY OF THE FOLLOWING APPLY TO YOU:

❈ When you do not use hearing aids, please charge the product
regularly to avoid battery damage; the recommended charging time
interval of hearing aids is ≤28 days.
❈ We recommend getting a medical check to ensure there is no
injury or illness related to the ears prior to using this device.
❈ Pay attention to moisture, shock and high temperature of the
product.
❈ Do not immerse the hearing aid in any liquid. Remove the hearing
aid before swimming or bathing. After swimming or washing, wait for
the ear canal to dry before wearing the hearing aid.
❈ After removing the hearing aid at night, it should be placed in a
case with a desiccant if possible, protected from light, high
temperature and high humidity environment, as well as from falling.
❈ The external surfaces of the hearing aid should be kept clean, and
the earwax in the ear domes should be cleaned out daily.
❈ The volume control knob should be used correctly, turn it as lightly
as possible, avoid excessive force.
❈ If your ears feel uncomfortable during use, please stop using the
hearing aids immediately.
❈ Don’t put the hearing aids in reach of infants and young children. If
swallowed accidentally, please consult a doctor immediately.
❈ Applicable objects: Suitable for people with air conduction hearing
loss of about 30-50dB.
❈ Please use hearing aids with hearing aid charging cases.
Notice
IV. MATTERS NEEDING ATTENTION & TIPS
8

Specific Warnings/Statements
❈ Keep small parts away from and out of children’s reach to
avoid accidental ingestion
❈ Warning not to use in explosive or oxygen-enriched
atmospheres, as doing so may damage the device
❈ Warning that it should only be used by intended person as
using hearing aids designed for someone else may result in
hearing damage
❈ USB cable: 1 piece
❈ Ear tips: 6 pieces
❈ Cleaning tool: 1 piece
❈ Charging case: 1 piece
❈ User manual: 1 piece
Notice
III. ACCESSORY KIT
9

Turn the knob from “OFF” to “1”, the hearing aid is
turned on.
Choose one of the three different sizes of ear tips
that suits you and fit it to the sound outlet of the
hearing aid.
Adjust the volume knob to the appropriate position.
Fit the hearing aid ear tips deeply within your ear
canal until it is stable.
When removing it after use, gently remove the ear tips
by pulling on the line.
After use, turn the knob to the “OFF” position.
If the power is too low to work, please put the hearing
aid in the charging case to charge.
❈ The knob can switch the power as well as the volume, please
always turn it off when not in use.
[How to use hearing aids]
1.
2.
3.
4.
5.
6.
7.
❈ Notice: Please turn off the hearing aid when charging
❈ If whistling/feedback occurs, please check if your hearing aid is
being worn according to the right steps. If the operation is correct
but whistling persists, please replace it with a bigger sized ear tip.
How To Use Your Device
I. TURN ON & OFF
10
Ear Tip
Microphone
Removal Cord
Volume Knob
Charging Contacts

How To Use Your Device
11
Table 1: Hearing aid failure self-checking table
Table 2: Charging case fault self-checking table

[How to use the hearing aid charging case]
Charging the charging case: When the USB cable
connected to the power adapter is inserted into the USB
port of the charging case, the screen of the charging case
lights up.
When the blue light in the battery icon marked “Case” is
on, it indicates the status as follows:
❈ When the blue light blinks, the case is charging;
❈ When the blue light is all lit and stops blinking, the
case has completed charging;
When using the adapter to charge the charging case, the
hearing aids are charging as well.
II. CHARGING
How To Use Your Device
12

NOTE: Always use the original accessories provided by Ceretone. Change or
replace the accessories if worn out or damaged as the safety and effectiveness of
the device may be reduced. 13

II. CHARGING
1. Removing Your Devices From The Charger
Pull up on the removal cord to remove the device from
the charger.
2. Inserting Your Devices Into The Charger
Remove the device from your ear, and gently push
straight down on the body of the device. When correctly
positioned, the blue cradle light will turn on and the
hearing device indicators on the display screen of the
charger will scroll, then show the charge level.
How To Use Your Device
FINDING THE PERFECT FIT
Grasp the body of the device between your thumb and
index finger. With your other hand, grasp the regular size
ear tip on one side at the bottom and peel it up and away
from the body of the device.
14
III. WEAR & REMOVAL

How To Use Your Device
INSERTING HEARING AID & STARTING USE
1. To insert the device into your ear, hold it with your
thumb and index finger, grasping the removal cord.
2. Gently insert the tip of the device into your ear canal.
Softly press it into place with your finger.
REMOVAL
1. Grasp the removal cord and gently pull.
15
III. WEAR & REMOVAL

Note: Everyone’s ear canals are shaped differently. In fact, it is not
uncommon for the left and right ear canals to bend in different
directions, even in the same person. If you feel light resistance
when you first insert the device, and it doesn’t feel like it has gone
in all the way, the device might just need a little help. Give it a little
nudge left, right, up, or down to see if you have a bend in your ear
canal, and if you can, nudge it around the bend so it goes into place
more fully. To help you find the best fit, you can also rotate the
device once it is in your ear canal until it feels secure. PLEASE
always be gentle and don’t ever force it.
❈ Make sure that the ear tip is correctly attached prior to
inserting the device. In rare cases the ear tip could remain in
your ear after removing the device. If this happens, have the
ear tip removed by a healthcare professional.
❈ If you apply hairspray or cosmetics, please do so
BEFORE inserting the ELIX K1V devices, otherwise they could
clog the microphone. Likewise, if you apply hand lotion,
please do so AFTER the devices have been inserted, so the
lotion does not clog the microphone.
❈ Consult your hearing care professional if you have
difficulties removing the hearing aid.
❈ After removal, it’s a good idea to inspect your devices
for wax buildup, or to replace the ear tips as needed. You can
read more about this in the Cleaning section.
How To Use Your Device
16
III. WEAR & REMOVAL

Your devices have three volumes, ranging from different
amplifications. To go from one volume to the next, turn the
knob for volume control.
Stop Using the Hearing Aid:
1. If any of the symptoms described below occurs, stop
using the hearing aid and seek medical assistance or
contact your hearing aid dispenser:
❈ There is a rash or eczema on parts where the
hearing aid contacts the skin.
❈ The skin contacting parts of this hearing aid are
made of a special material designed to minimize skin
irritation. ❈ However, in rare cases, allergic reactions
may occur, which can lead to eczema.
❈ There is discharge from the ear during hearing aid
use, or treatment of the ear has become necessary.
❈ Hearing capability has suddenly deteriorated
markedly.
2. In rare cases, the ear tip could remain in your ear after
removing the device. If this happens or you cannot locate
the ear tip, have a healthcare professional remove it or
verify it is not still in your ear.
AMPLIFICATION LEVELS
17
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