Kinetik JH-125 Instruction manual

KINETIK WELLBEING

HEARING AMPLIFIER

USER MANUAL

Please read instructions carefully before operating this device.

Thank you for buying the Kinetik Wellbeing Hearing Amplifier.

This device will enhance your hearing both indoors and outdoors.

Please read instructions carefully before use.

I．INTRODUCTION

1.1What is hearing loss?

A speech frequency puretone average (average of
hearing thresholds at 0.5, 1, 2 and 4 kHz) or greater
than 25 dB hearing level (HL) in both ears was defined
as hearing loss as per the World Healt h Organization
criteria, and this is the level at which hearing loss begins
to impair communication in daily life. (Extracted from the
literature of: World Health O rganization prev ention of
Blindness and deafness (PBD) program. Prevention of
Dea fness and Hearin g-Impaired Grad es of Hearin g
Impairment)

1.2 What’s the hearing amplifier?

The Kinetik Wellbeing hearing amplifier is a wearable,
sound-amplifying air-conduction aid. The fundamental
principle of the hearing amplifier is to rec eive, amplify
and transfer sound to the ear drum of the user.

Introduction

Intended Use

Important Safety Instructions

Know your Device

How to Use

Maintenance and Cleaning

Troubleshooting

Specifications and Type

Explanation of Symbols

Maintenance, Storage and Disposal

Guarantee

01

02

02

08

09

13

15

17

22

23

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II. INTENDED USE

2.1 Medical purpose

The hearing amplifier is intended to assist those with
impaired hearing.

2.2 Intended patients and environment

The hearing amplifier c an be used indoors and
outdoors.

If a doctor has decided that you require a hearing ampli­fier - patients must be over 36 months old.

2.3 Side effects

- Patients sensitive to silicone may experience ear canal
pruritus.

- F irst us e may caus e s light pain as the ear canal
adjusts to the hearing amplifier.

III. IMPORTANT SAFETY INSTRUCTIONS

Read all the informat ion in the instruction manual and
any other literature included in t he box before using the
device.

01

3.1 CONTRAINDICATION

The device is unsuitable and should not be used in t he
following situations:

- Patients with chronic suppurative otitis media, congen­ital ear atresia;

- T his hearing amplifier can only be used to assist
patients with hearing impairment, there is no therapeutic
value.

- The hearing amplifier cannot be used by infants under
36 months old.

3.2 WARNINGS

- Keep small parts (hearing instrument, battery and
detachable parts) that can be swallowed out of
children’ s reach.
electromagnetic fields or excessive heat will damage
the hearing amplifier. If parts remain in the ear, please
go to see a doctor as soon as possible, do not take it
out by yourself.

- Remove t he battery i f it is not likely t o be used for
some time – this is to avoid battery leakage.

- Remove the sealing on the positive side of battery
before loading. The battery operates normally in about 1
minute after the sealing is removed.

Dropping, immersing in liquid, strong

WARNING

WARNING

03

Don’ t throw the scrapped battery as common rubbish, it
should be handled with specialist equipment, to avoid
environmental pollution.

- Do not use this product near explosive or dangerous
environments, to avoid damaging the hearing amplifier.

- Keep device away from children as there is a risk of
injury to the child or others, or damage to the device.

- Don’ t use in an oxygen rich environment for long
periods as this may damage the device.

- Do not se t volume lev els too high. Listening f or
extended periods at high volume levels can c ause
further hearing damage. Special care must be taken
because this hearing amplifier is a high-output type.

- Do not lend your hearing amplifier to other persons.
Using a hearing amplifier designe d for someone else
can result in hearing damage.

- Monitor any unusual skin reaction. In some instances,
wearing a hearing amplifier c an cause an allergic
reaction leading to itchiness or rashes. If you notice any
unusual skin condition, stop wearing the
er and see a medical specialist.

- Do not put a mag ne tic item into contac t w ith the
hearing amplifier as this may damage the device.

hearing amplifi-

02

- Open the battery compartment lid. Load a battery into
the battery compart ment with correct polarity, the plus
mark＋on the battery and the lid should be on the same
side. Otherwise, the hearing amplif ier will not work
properly.

- Close the battery compartment lid. Dispose of batter ­ies and the h
manage ment protocol. Do not throw into fire, as the
battery may explode.

- Always store batteries out of reach of children, to avoid
accidental swallowing.

3.3 Notice

- Don’ t use devic e at high volume for a long time ­otherwise it may injure your ear. If you feel uncomfort ­able, please stop using.
Please maintain the products at all times. Pre vent the
earplug and acoustic opening from becoming obstructed
with foreign matter. This im pairs the functio n of sound
amplification.

- Prote ct the devic e from impacts, humidity and high
temperatures.

earing amplifier following battery recycling

04

- Be sure to take off the hearing amplifier when getting a
diagnosis or treat ment regarding your hearing ( If you
get them with hearing amplifier worn, ens ure that the
hearing amplifier is not activated.)

- Do not touch the interior of the hearing amplifier as it
contains many delicate parts that are precision adjust­ed. Never pry the inside of the hearing amplifier with a
needle or similar object, otherwis e it will damage the
device.

- Do not place in a hot or humid location. You should
never leave y our hearing amplifier near heating
appliances or in direct sunlight, and you should also
avoid humid locations such as ba throoms or n ear a
humidifier. Otherwise it will damage the device.

- In a closed car in summer, the temperature can rise to
very high levels. Do not leave your hearing amplifier in a
car, otherwise it may damage the device.

- Do not use the hearing amplifier together with a mobile
phone, otherwise it may increase the noise and affect
the sound quality.

- Radio wave emissions from mobile phones can cause
noise in t he hearing amplifier or result in reduced
volume.

05

- Please contact Kinetik Wellbeing for assistance:

• in setting up, using or maintaining the hearing amplifi
er; or

• to report unexpected operation or events.

Specific warnings

Specific warnings / statements

Keep small parts out of children´s reach, to avoid them
swallowing parts

Warning - Common conditions that can damage the
device

Warnings that result from the risk management file

Permissible environmental conditions of transport and
storage

Each warning/safety contains: nature of Hazard, likely
consequence; precautions.

Statement about the special needs of particular Patient
groups

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List of accessories

Part name Type and

Battery A13 battery

specification

D.C. 1.4V
(JH-115:
d.c. 1.5V)

Earplug Silicone gel 3pcs 031-010000-001

NOTE: Always use the original accessories from
Kinetik Wellbeing. Changing or replacing the accesso ­ries without cons ulting Kinetik may be uns afe and
reduce effectiveness of the device.

QTY Part no.

1pc 030-700501-542

V. HOW TO USE

Turn on the device

1)Before use, make sure the power is off, or set the
volume to “1”.

2)When the battery compartment is closed, put amplifi­er on the ear and switch the “O-N switch” to N position
to turn on the device

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IV. KNOW YOUR DEVICE

NO.

Parts Description Function

A

Microphone

B

Volume control

C

On/Off switch

D

Battery compartment

E

Ear plug

F

Headphones

G

Ear Tube

Inserting/Replacing the battery

1)When the sound is weak, this
may indicate that the battery is
low and needs to be replaced.

2)Open the battery door completely.
Remove the used battery if present.

3)Prepare the new battery. Insert the new battery with
the positive side in the correct position.

4)Gently close the battery door.

Initial use and operation

1)Connect the earplug on the amplifier tightly.

2)Put the ear hook on your ear, plug in the ear plug
tightly.
(Note: T he unit is on “off ” position. And volume is on
“1” , otherwise the instant sound may be uncomfort­able).

3) Adjust the sound volume to get clear sound.

4) If you hear a whistling sound, please check whether
you have inserted the ear plug correctly int o the ear
canal. If it can’t insert deeply, please change to another
silicone tip.

/
“1~4” Volume grade,

“1”Min, “4”Max
“N” means “Power On”
“O” means “Power Off”

“+” Positive electrode of

Battery

“-” Negative electrode of

Battery

/

/

/

09 10

5) A hearing amplifier cannot cure hearing loss, but it
can augment your hearing and improve understanding
of speech. However, if the volume is set too high, or if
an unsuitable hearing amplifier is used, damage to the
ear may occur.

6) Before using a hearing amplifier, be sure to have
your hearing t ested at a medic al facility or b y a
qualified hearing amplifier dispenser. Hearing amplifier
adj ustme nt should only be carried out by a trai ned
professional, such as an otolaryngologist, audiologist,
or qualified staff at a hearing amplifier dispensary.

7) Keep the volume level low at first, and then gradual­ly increase it as you get used to the hearing amplifier.

8) The hearing amplifier is adjusted
for your individual requirements.
It will not fit and may cause
hearing damage and infection
when worn by other persons.
Do not lend your hearing
amplifier to others, and do not
use a hearing amplifier belonging to someone else.

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-- There is a rash or eczema where the hearing amplifi­er has contact with skin.

-- The parts o f the hearing amplif ier that come into
contact with skin 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 fr om the ear during heari ng
amplifier u se, or treat ment of the ear has become
necessary.

-- Hearing capability has suddenly deteriorat ed mark­edly.

VI. MAINTENANCE AND CLEANING

6.1Daily maintenance

It is important to keep your
instrument clean and dry.
On a daily basis, clean the
hearing instruments using
a soft cloth or tissue. In order
to avoid damage due t o humidity or excessive persp i­ration, the use of a drying kit is recommended.

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Note:

-Hearing problems in children are especially difficult to
diagnose. Children should only be fitted with a hearing
amplifier under the supervision of an otolaryngologist.

- If you currently hav e an ear ailment or hav e had an
ailment in the past, consult your physician before using
a hearing amplifier.

- You s hould nev er attempt to bend or modify the
shape of the thin tube.

Removal

1）Hold the thin tube with your thumb and forefinger.
2）Then remove the ear hook from your ear. If any part
of the hearing amplifier remains in the ear consult a
professional immediately.
3）Consult your hearing care professional if you have
difficulties removing the hearing amplifier.

Stop using the Hearing Amplifier

1) If any of the symptoms
described below occur, stop using
the hearing amplifier and seek
medical assistance or contact
your hearing amplifier dispenser:

6.2Care and maintenance

Put it out of reach from children, keep dry and do not
expose in the sun.
Do not expose the hearing amplifier to heat from
stoves, etc. Also, avoid leaving it in places with high
humidity.

Operate the controls with care. Do not press hard.
If the hearing amplifier is dropped in water, wipe with

dry cloth and contact manufacturer.
Do not pick the microphone with nail, pin, etc. As this
will cause the microphone to be damaged.
Do not disassemble or a ttempt any repairs by
yourself. Contact Kinetik Wellbeing for assistance.

6.3Cleaning

1)Cleaning the earplug

Remove ear wax in the earpiece
using a cotton bud.

2)Cleaning hook

Using a soft cloth or tissue wipe off any moisture,
perspiration, or debris from the surface of the hook.
Note: Do not use alcohol or other cleaning solvents to
clean the hook as this could damage the protective
covering.

VII. TROUBLESHOOTING

Check the following if the device should fail during
operation.

Problem Cause Remedy

No sound 1). Power is off.

2). Battery is incorre

-ctly fitted.

3). Battery is flat.

4). Earphone is dama

-ged.

5). Lead is broken

6). Hearing amplifier
is dropped in water or
other liquid.

7). Hearing amplifier
was in a microwave
oven, a dish dryer, or
used with a hair dryer.
This may damage the
hearing amplifier.

1) Turn on the devices;

2) Remove and re

-install the battery;

3) Replace the new
battery;
4/5) Contact Kinetik
Wellbeing or distributor;

6) Carefully wipe it off
with a soft, dry cloth.
Then have it tested by
your hearing amplifier
dispenser as soon as
possible.

7) Please ensure total
compliance with
manual.

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Problem

Cannot
hear
sound well

Cause Remedy

1)Battery is flat

2) The receiver or
tube is clogged with
earwax

1) Replace with a new
battery.

2) Remove the receiver
and tube from the
hearing amplifier and
carefully wash these
parts with lukewarm
water or similar.

VIII. SPECIFCATIONS AND TYPE

Device name

Mode JH-125

Type

Power supply

Working current ≤10mA 1.5V

Sound travels
mode

Signal process

-ing method

Max sound
output (Peak
OSPL90)

Hearing Amplifier

BTE

DC 1.5V, LR754 button battery
(JH-115: DC1.5V)

Gas conductivity

Analog signal amplification

≤ 133+3dB

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Problem Cause Remedy

1). Battery power is

The sound

weak.

is very

2). Damage or fault to

weak and

earphone.

vague

3). Receiver or tube is
clogged with earwax.

4). Battery compart

-ment is not properly
closed.

5). Tube is blocked by
water droplets.

Receiver of the

Volume

hearing amplifier

level set

does not fit the ear

too high

properly, or a whistl

-ing unpleasant noise
is heard (which is
caused by acoustic
feedback).

Sound gain
(HFA Full-on
gain，50 dB SPL
input)

Sound pressure
level (HFA
OSPL90)

Total harmonic
distortion

≤42+3db

126.8±3dB

≤10% 1600Hz

1）Replace the new
battery;
2）Contact your distri

-butor;
3）Remove the receiver
and tube from the
hearing amplifier and
carefully wash these
parts with lukewarm
water or similar.
4）Close the battery
compartment correctly.
5）Remove the tube
and shake it or blow
through it to remove
the water.

1)Turn the hearing
amplifier off and
reposition it properly in
the ear.
If the receiver does not
fit your ear properly, try
replacing it with another
type. The use of a
correctly fitted ear mold
is recommend. Please
consult your hearing
amplifier dispenser.

Frequency range 300-4000Hz

Input noise （EQ
input noise）

≤ 45dB

Material of shell ABS

Material of hook PVC

Material of ear
plug

Type of protection
against electric
shock

Degree of protec

-tion against
electric shock

Silicone gel

Internally power supply

Continuous operation

Grade of
waterproof

Product life

IP41

3 years

Sterilized? No

Used in an
Oxygen Rich
Environment

No

Software version V1.0

Operation
environment

Storage &
transportation
environment

*The above specifications are subject to change without
prior notice.Result of Maximum output (OSPL 90)
Result of Full-on and reference test gain

-10~40℃, 30%~75%RH,
860-1060hPa

-10 ~+50 ℃, ≤90%RH,
700-1060hPa

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Performance Characteristics accordingto IEC 60118-0: 2015

OSPL90
Model

Maximum
(dB SPL)

HFA- OSPL90
(dB SPL)

Full on gain (input 50 dB SPL)

Model

Maximum (dB)

FA- FOG(dB)

Reference test setting(RTS)
Model
FrequencyRange (Hz)
Reference test Gain (dB)
Current Drainat RTS (mA)
Typical Battery Life (h)

Equivalent Input Noise
atRTS (dB SPL)

Total Harmonic
Distortion at
500Hz/800Hz
/1600Hz (%)

JH-125
<125±3dB

126.8±3dB

JH-125

40±5dB

35dB±5dB

JH-125

100~6000Hz

≤ 32dB

<10mA
120H

≤ 32dB

≤10%

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1）Measured by Huizhou JINGHAO medical technology
Co., Ltd.

2) The test result was according to IEC 60118-7:2005.

Notes:

-This hearing amplifier is produc ed under the strict
quality system of Huizhou JINGHAO medical technolo­gy Co., Ltd.

-The dev ice f ulfils the provisions of the EC directive
93/42/EEC (Medical Device Directive) and the Harmo­nize Standard as IEC 60601-1, IEC 60601-2-66, IEC
60118-7, IEC 60118-13, EN ISO 10993-1/-5/-10 and EN
ISO 14971.

IX. EXPLANATION OF SYMBOLS

Follow operating instructions

BF type applied part

Disposal in accordance with Directive
2002/96/EC (WEEE)

Complies with the European Medical
Device Directive (93/42/EEC and amended
Directive 2007/47/EC. Notified Body is
SGS United Kingdom Ltd.

Manufacturer information:
The manufacturer is: Huizhou JINGHAO
medical technology Co., Ltd.

Authorized representative in the European
Community. The European representative
is: Shanghai International Holding Corp

Date of manufacture

Serial number

Warning/ Danger: Improper use might
cause serious injuries.

IP code of the device: this device’s grade
of against ingress of solid foreign objects
– the access probe of 2.5 mm Ø shall not

IP41

penetrate; the grade of waterproof is v
ertically falling drops shall have no
harmful effects.

X．MAINTENANCE, STORAGE AND DISPOSAL

10.1 Maintenance

1)We do not autho rise a ny institu tion or i ndividual to
maintain and repair the product. If you have any ques­tions, please contact the manufacturer or distributor.

2)The user must not attempt any repairs to the device or
any of its accessories. Please contact the manufa cturer
for repair.

3)Opening of the equipment by unauthorised agencies is
not allowed and will terminate any claim to warranty.

warning: No modifi cation of this equi pment is
allowed!

10.2 Storage

1)If you don’ t use it, turn off the hearing amplifier, take
out the batteries, and then put it into the travel case.

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Huizhou Jinghao Medical Techology Co., Ltd.

Address: Floor 6, Huicheng Industry Building, No.9
HuifengDong’er Road, Zhongkai High-tech Zone,
Huizhou City, Guangdong Province, China.

Shanghai International Holding
Corp.GmbH(Europe)
Eiffestrasse 80, 20537 Hamburg, Germany

2)Don’ t put the device directly in the sun, high tempera­ture and moist environments or where it is vulnerable to
fire or vibrations.

3)Keep the device storage in following env ironmental
ranges:

-10~50℃, ≤90%RH, 700-1060hPa

10.3 Disposal

Please dispose of the device in accordance with t
directive 2002/96/EC – WEEE (Waste E lectrical
and Electronic Equipment). If you have any queries,
please refer to the local authorities responsible for
waste disposal.

he

XI.GUARANTEE

Any damage caus ed by improper handling shall not be
covered by the guarantee. User damaged packaging are
also excluded from t he guarantee. All other damage
claims excluded. A guarantee claim must be submitted
with th e purchase receipt. Pleas e pack your defective
instrument well and send with tracked postage to Kinetik
Wellbeing.

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