DUEARITY 6103 Tinearity G1 Treat Tinnitus Using White Noise User Manual

: June 14, 2024
: DUEARITY

Table of Contents

DUEARITY 6103 Tinearity G1 Treat Tinnitus Using White Noise
Product Information
Product Usage Instructions
FAQs
INDICATIONS FOR USE
Packaging content
TINEARITY™ G1 DESCRIPTION
DEVICE DESCRIPTION
PREPARATION BEFORE FIRST USE
OPERATING INSTRUCTIONS USER
MAINTENANCE
CHARGING THE BATTERIES / SOUND GENERATOR
TROUBLESHOOTING
MANUFACTURER’S WARRANTY
IMPORTANT INFORMATION
DESCRIPTION OF SYMBOLS
CONTACT
Read User Manual Online (PDF format)
Download This Manual (PDF format)

DUEARITY 6103 Tinearity G1 Treat Tinnitus Using White Noise

Product Information

Specifications
- Model: REF 6103
- Date of Issue: 2024-04-16
- Intended Use: Relief and treatment of tinnitus symptoms
- Target Population: Adults over 18 years of age with normal hearing
- Lifespan: 24 months from the manufacturing date

Product Usage Instructions

Indications for Use
- The Tinearity G1 device is designed to generate noise to mask ringing in the ears or internal head noise for patients with normal hearing. It is intended for use in the home healthcare environment.
- Important: Consult a hearing healthcare professional for diagnosis, fitting, and follow-up care.
Contraindications
- The device is not suitable for individuals with hearing loss or hyperacusis.
Possible Side Effects
- Possible side effects may include irritation behind the ear from the adhesive tape and worsening tinnitus symptoms from white noise. Stop use if experiencing headaches, nausea, or dizziness.
Useful Life / Service Life
- The device and charger have a lifespan of 24 months from the manufacturing date. Check the expiry date on the adapter label.
System Overview
- The Tinearity G1 device generates white noise to treat tinnitus symptoms by transmitting sound to the inner ear via bone conduction. It can be used throughout the day, including during sleep.
- Caution: Do not clean or immerse the sound generator in liquids.
Packaging Content
- The packaging includes the Tinearity G1 device, charger, plastic holder, medical tape, and disposable adapters.

FAQs

Q: Can the Tinearity G1 device be used by individuals with hearing loss?
- A: No, the device is not intended for users suffering from hearing loss or hyperacusis.
Q: How often should the disposable adapter be replaced?
- A: The adapter should be replaced as needed, and its expiry date is indicated on the label.
Q: What should I do if I experience headaches or dizziness while using the device?
- A: Stop using the device immediately and consult your healthcare professional for guidance.

THE USER MANUAL

The Tinearity TM G1 device is designed to relieve and treat the symptoms of tinnitus. The device can be used at home, at work, and in public environments.
This user manual provides instructions on how to use and maintain your new Tinearity™ G1 device.
Please carefully read this manual to learn how to use the device. Pay attention to all warnings as indicated in this manual. If you have any questions, please contact your country’s representative.
Note The patient is the intended operator of the device.

WARNING SYMBOLS USED IN THIS MANUAL

WARNING Indicates a potentially hazardous situation which, if not avoided, could result in injury.
CAUTION Indicates a potentially hazardous situation which, if not avoided, could result in damage to the Tinearity G1 device and the nearby surroundings.
Note Indicating useful information about the safe use of the device.

INDICATIONS FOR USE

Indication for use

Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noise to provide relief for patients with normal hearing in the home healthcare environment.
The device is for prescription use only.
The target population is the adult population over 18 years of age.
Linearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea. Hearing health care professionals shall be consulted for diagnosis, fitting of devices, and follow-up care.

Contraindications

The device is NOT intended for users suffering from hearing loss or hyperacusis.

Possible side effects

The adapter consists of a plastic holder and medical tape. The tape has an acrylic adhesive that adheres the adapter to the user’s skin. Irritation may occur behind the ear when replacing the disposable adapter.
White noise may result in worsening tinnitus symptoms. Bone-conducted sound may result in headache, nausea and/or dizziness. If any of this occurs, stop using the device and consult your healthcare professional.

Useful life / service life

The device and charger have a useful lifespan of 24 months, starting from the manufacturing date.
The expiry date of the adapter is indicated on the label.

SYSTEM OVERVIEW

Your Tinearity G1 device is designed to relieve and treat tinnitus symptoms by generating white noise that is transmitted to the inner ear via the skull. This method enables treatment without obstructing your ear canal.
You can use your Tinearity G1 device throughout the day, including during sleep.

CAUTION The sound generator must never be cleaned or immersed underwater or in other liquids.

Packaging content

Tinearity™ G1 Sound Generator, one pair (2pcs)
Tinearity™ G1 Adapters (62pcs)
Tinearity™ G1 Charger
USB cable
IFU

Note A power supply to connect the charger to a wall outlet is not included, see section 12.
WARNING The Tinearity™ G1 device contains small parts that may pose a choking hazard to small children. Always keep the charger station, the sound generator, and the adapter out of reach of children.
WARNING The USB cable included in the packaging may pose a choking hazard and should be kept away from children.

TINEARITY™ G1 DESCRIPTION

The Tinearity™™ G1 device comprises three components: (1) the sound generator, (2) adapters and (3) charger (including a USB cable for connection to a power supply). The sound generator is attached to the skin behind the ear using the adapter.
The sound generator works within the frequency of 700 Hz-10kHz with a maximum output level of 48 dB HL. The sound generator is supplied in pairs, to be used behind both ears.
The adapter consists of a plastic holder compatible with the sound generator and a medical grade tape that adheres to the skin. The adapter should be disposed of daily or after each treatment.
The sound generator uses a rechargeable battery as a power source. Recharge the two sound generators simultaneously by using the charger plate and the separate USB cable for connection to a compatible power supply.
The Tinearity™ G1 sound generator and adapter can be used at any time during the day & night.
CAUTION The sound generator must never be cleaned or immersed underwater or in other liquids.

DEVICE DESCRIPTION

Sound generator

The sound generator converts white noise into vibrations. It is powered by a rechargeable lithium-ion battery.
CAUTION The sound generator contains electrical parts and should be disposed of as electrical waste.
Note For explanation of the symbols, see section 15.

Adapter

The adapter transmits the vibrations generated by the sound generator to the inner ear through the skull.

Charger

The charger is used to charge the sound generators. Safety information is marked on the underside of the charger.
- Figure 4. Charger device label
- WARNING The connecting cable is included in the packaging and might pose a risk of choking, keep away from small children.
- CAUTION The sound generator contains electrical parts and shall be disposed of as electrical waste.

Packaging labels
The Tinearity G1 system is delivered in one box. The box includes packages for adapters and sound generators. Each packaging level has its own label as illustrated in figure 5-8 below.

Note for an explanation of the symbols see section 15.

PREPARATION BEFORE FIRST USE

Unpack the parts and inspect for any signs of damage, then follow the cleaning instructions for the sound generator and charger in section 8.
Check the safety-related labelling on the TinearityTM G1 device for legibility.
Make sure that the power supply (not provided in the package) connecting the charger to the wall outlet has the following performance:
- USB-A port, 5V DC, min 1000mA, Max 1500mA
- Double insulated
Fully charge the sound generators using the supplied charger, see section 9.

PREPARATION BEFORE EVERY USE

Skin hygiene
- The skin behind the ear must be clean, dry, intact, and free from hair. If needed, remove any excess hair to ensure an adequately sized contact area.
- Clean the skin with mild soap and let it dry completely before you apply the adapter.

Sound generator and adapter

Visually inspect the sound generator and adapter for any damage, before use.
WARNING If covers are damaged or any parts are loose, do not use the device.
Clean the sound generator according to section 8.

Charger

Place the device on a flat surface.
WARNING Check that the cable and connections are not pinched or damaged. Pets and pests may damage the insulation of the cables. Do not use damaged cables.

OPERATING INSTRUCTIONS USER

Applying the adapter

Locate the area for application of the adapter behind the ear. To maximize the performance of your treatment, ensure that the adapter is positioned over the mastoid bone and orientated as illustrated in the figure below. Make sure that the area is free from hair.
- Note Transmitting sound via bone conduction is most effective if the adapter is attached to the thinnest part of the skin.
- Note The curve of the adapter is designed to match the curve behind the ear, therefore ensure the adapter is rotated as shown for a proper fit.
Hold the adapter by its wings.
Remove the protective film, do not touch the adhesive surface.
- Gently press the highlighted surface of the adapter for at least 20 seconds. Figure 14.
- WARNING Risk of skin damage. Only use the adapter provided by Duearity and according to this manual.

Connecting the sound generator
To connect the sound generator safely and comfortably to the adapter, tilt it slightly and gently push it into the adapter until it clicks into place.

Note The side of the sound generator marked with CE2862 shall be towards the adapter.

Turn the sound generator on and off
Turn your sound generator on and off by pressing the power button. A short press turns your sound generator on, and a longer press turns your sound generator off.

Note Use a short press to turn your device on, a long press to turn your device off.

Adjust the volume
Adjust the volume according to the prescription from your healthcare professional. Your sound generator is by default started at mid-volume and the volume can be increased by 10 steps and decreased by 10 steps. Each step represents 2 dB HL.

Treatment

Follow the recommendations of your healthcare professional.
WARNING Risk of hearing damage. If you experience discomfort or if your tinnitus worsens, stop treatment immediately and contact a healthcare professional.

Remove the sound generator

Remove the sound generator by holding it and firmly pressing the handle furthest away from the ear on the adapter. The sound generator will then disconnect.

CAUTION To avoid damage to the device, charge the device after each use.

Remove the adapter

Remove the adapter by slowly peeling it off the skin. The adapter is single-use only and must be disposed of after each use.
WARNING Risk of skin damage, only use the adapter provided by Duearity and according to this manual.
Note Dispose the adapter after each use.

MAINTENANCE

Store your TinearityTM G1 device in a room temperature protected from dust, dirt, and sunlight. Before each use, clean your device as follows.

Note Your sound generator is protected against the ingress of water but is not waterproof.

Preparation for cleaning

Separate your sound generator from the adapter.
Make sure your sound generator is turned off.
Remove the USB cable from the charger.
Note the adapter is single use and shall be disposed after each use/treatment, no cleaning is needed.

Cleaning the sound generator and the charger
Clean your sound generator and charger at least once every seven days using soft cleaning wipes on the outside. The duration of the cleaning action shall be minimum 1 minute. Make sure to reach all areas. The level of cleaning shall be as minimum equivalent to general personal grooming items. Inspect the sound generator and charger to ensure no visual contamination remains.

CAUTION Your sound generator is protected against ingress of water, i.e., it is designed to be used in your daily life but the sound generator is not waterproof.
CAUTION The sound generator should never be cleaned or submerged underwater or in any other liquids.
CAUTION The charger should never be cleaned underwater or in any other liquids.

CHARGING THE BATTERIES / SOUND GENERATOR

General information

The sound generator is powered by a rechargeable lithium battery with a maximum duration of 12 hours.

When to re-charge batteries/sound generator

Your sound generator should be re-charged after each use.
WARNING The sound generator includes coin cell batteries that may be corrosive if swallowed. Risk for small children. Always keep the sound generator out of reach for children.
If a battery is accidentally swallowed, seek medical attention at the nearest emergency department.

How to charge the sound generator

To charge the sound generator, follow the following steps:

Make sure that the Charger is placed in a room that has a temperature of maximum 95°F (35 C).
Place your sound generators) with the front side (indicated with the Duearity symbol) facing the inductive charger, see figure 20.
The blinking green light indicates that the device is charging.
Let the sound generator(s) charge until the indicators) stops blinking. A complete charge cycle is approximately 6 hours.
If the battery is completely discharged or if the ambient temperature exceeds 86°F (30°C) during charging, the charging rate will be reduced, but not completely halted, to prevent battery damage or overheating.
Your device(s) is/are now fully charged and ready for use.
- Note To avoid damage to the device, charge the sound generator after each use.

CONSUMABLES, SERVICE AND REPAIR

If your Tinearity™™ G1 device is not functioning properly or if you need to order additional adapters, please contact your distributor.

TROUBLESHOOTING

Table 1.

Symptom	Explanation	Possible Cause	Proposed action
No white noise is heard.	The amplitude of the white

noise must exceed the hearing threshold of the user.

| Hearing impaired.| Increase the amplitude

(turn up the volume), see section 7 .4.

No white noise is

heard.

| The batteries must be charged

after each use.

| The batteries

are discharged.

| Charge your sound

generator, see section 9 .

The sound generator falls off

from the adapter.

| __

The adapter is worn out.

| The adapter is single use.| Change adapter, see section 7 .1 and 7.7.

TECHNICAL AND REGULATORY INFORMATION Technical data and regulatory information
Table 2.

Environmental conditions| Sound generator| Inductive charger
---|---|---
Ambient air pressure
Operation| 700 hPa to 1060 hPa
Transport/ storage
Ambient temperature
Operation| +41 to +95 F
Transport and storage| -13 to +158 F
Ambient humidity
Operation| RH 15% to 93%, non-condensing
Transport and storage
Operational altitude| Max 3000 m over sea level
Classification
Medical device class| EU MDR2017/745 (MDR) Class IIa, US Class II
Applied standard| IEC 60601-1:2005+A1| IEC 62368-1:2014
Class| II| III
Environmental conditions| Sound generator| Inductive charger
---|---|---
Applied part category| BF| N/A
Protection of harmful ingress| IP 22| IP 21
Pollution degree| II| II
Mode of operation| Continuous use| Continuous use
Essential performance| No| No
Isolation from supply mains| N/A| Disconnect AD / DC adapter
Nominal voltage| 3,7 VDC| 5 VDC
Battery capacity| 50 mAh| No battery
Battery type| Rechargeable Li-ion

battery.

| No battery

Requirement for ac/ dc adapter Table 3.

Output power voltage	5VDC
Output power	Min. 1000mA, Max 1500mA
IP class	Minimum IP 21 (NEMA 3)
Class	II (NEMA 1-15P)
Approval	Certified to IEC 62368

EMC INFORMATION AND REGULATORY CLASSIFICATION Table 4

Electromagnetic Emissions

The TinearityTM G1 system is intended for use in the electromagnetic environment associated with a professional healthcare facility or a home healthcare environment as specified below. The customer or the

user of the TinearityTM G1 system should ensure that they are used in such an environment.

Emission Tests| Compliance
Radiated and conducted RF emissions EN 55011/CISPR 11

__

FCC 47 CFR, Part 15 Subpart B FCC 47 CFR, Part 18 Subpart C

| Sound Generator: Class B, Group 1 Charger: Class B, Group 2

__

Electromagnetic environment – guidance

The Tinearity™ G1 system uses RF energy only for their internal function. Therefore, its RF emissions are very low and are not

likely to cause any interference with nearby electronic equipment.

Harmonic emissions EN IEC 61000-3-2| Sound generator: Not applicable, battery-operated device

Charger: Not applicable, P < 75W

Voltage fluctuations/flicker emissions

EN IEC 61000-3-3

| Sound generator: Not applicable, battery-operated device

Charger: Not applicable, P < 75W

Table 5.

Electromagnetic Immunity

The Tinearity™ G1 device is intended for use in the electromagnetic environment specified below. The user should ensure that the device is used in such an environment.

__

Immunity Tests

| Basic EMC

standard or test method

| Immunity test levels
Professional Healthcare

facility environment

| Home healthcare

environment

Electrostatic Discharge| EN IEC 61000-4-2| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Radiated RF EM fields| EN IEC 61000-4-3| 3 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

Proximity fields from RF wireless communications equipment| EN IEC 61000-4-3| Test frequency

(MHz)

| Service| Immunity Test

Level (V/m)

385| TETRA 400| 27
450| GMRS460,

FRS460

| 28
710

745

780

| __

LTE Band 13, 17

| __

9

__

810

870

930

| GSM 800/900, TETRA800, iDEN 820,

CDMA 850,

LTE Band 5

| __

__

28

__

1720

1845

1970

| GSM 1800,

CDMA 1900,

GSM 1900, DECT,

LTE Band 1, 3,

4, 25, UMTS

| __

__

28

__

2450

| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450,

LTE Band 7

| __

__

28

5240

5500

5785

| WLAN 801.11

a/n

| __

9

Electrical Fast Transient/Burst| EN IEC 61000-4-4| ±2 kV for power supply lines
Surges| EN IEC 61000-4-5| Sound generator: Not applicable, battery- operated device

Charger: Tested through generic AC/DC adapter

Line-to-line: ±0.5 kV, ±1 kV

Electromagnetic Immunity

The Tinearity™ G1 device is intended for use in the electromagnetic environment specified below. The user should ensure that the device is used in such an environment.

__

Immunity Tests

| Basic EMC

standard or test method

| Immunity test levels
Professional Healthcare facility environment| Home healthcare

environment

Electrostatic Discharge| EN IEC 61000-4-2| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Radiated RF EM fields| EN IEC 61000-4-3| 3 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

Proximity fields from RF wireless communications equipment| EN IEC 61000-4-3| Test frequency

(MHz)

| Service| Immunity Test

Level (V/m)

385| TETRA 400| 27
450| GMRS460,

FRS460

| 28
710

745

780

| __

LTE Band 13, 17

| __

9

__

810

870

930

| GSM 800/900, TETRA800, iDEN 820,

CDMA 850,

LTE Band 5

| __

__

28

__

1720

1845

1970

| GSM 1800,

CDMA 1900,

GSM 1900, DECT,

LTE Band 1, 3,

4, 25, UMTS

| __

__

28

__

2450

| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450,

LTE Band 7

| __

__

28

5240

5500

5785

| WLAN 801.11

a/n

| __

9

Electrical Fast Transient/Burst| EN IEC 61000-4-4| ±2 kV for power supply lines
Surges| EN IEC 61000-4-5| Sound generator: Not applicable, battery- operated device

Charger: Tested through generic AC/DC adapter

Line-to-line: ±0.5 kV, ±1 kV

CW = Continuous Wave (non-modulated), PM = Pulse Modulated

MANUFACTURER’S WARRANTY

Duearity sound generators and chargers are covered by a limited warranty issued by the manufacturer. The warranty period is 24 months from the date of manufacture. This limited warranty covers manufacturing and material defects in the sound generator or charger itself.
Duearity intends that this device should be used only according to these instructions for use and as directed by a physician with knowledge of the device. Problems arising from improper handling or care, excessive use, accidents, repairs, or exposure to corrosive conditions, are NOT covered by the limited warranty and may void the warranty.
Duearity shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from off-label use of this device. Duearity neither assumes nor authorizes any person to assume for it any other or additional liability or responsibility in connection with these devices. Federal law in the USA restricts this device to sale by or on the order of a physician.

IMPORTANT INFORMATION

Warnings

WARNING Risk of hearing damage. If you experience discomfort or your tinnitus worsens, stop treatment immediately and contact a healthcare professional.
WARNING Risk of electric shock. The sound generator has an IP22 classification and is water resistant but not waterproof. Always remove your Sound generator before showering or bathing.
WARNING Risk of electric shock. Use cables, chargers, adapters, and sound generators provided by the manufacturer, ONLY.
WARNING Risk of bodily injury. Never expose your Tinearity™ G1 device to extreme heat, do not dry the device in microwave ovens or other ovens.
WARNING Risk of electric shock or burns.
- Do not open the device.
- Do not use the device if the casing or cable is damaged.
- Do not service or repair the device.
- No modification of this equipment is permitted.
- Use only power supplies as specified in this instruction.
WARNING Risk of infection. This device must be used by one user and should not be shared between multiple individuals.
WARNING Risk of fire and hazardous smoke. Do not use the device in an oxygen-rich environment or areas with flammable gases.
WARNING Risk of affecting measurement results and treatment results. This device emits electromagnetic radiation, do not use it closer than 30 cm from other medical devices.
WARNING Risk of hearing damage. Patients suffering from hyperacusis (increased sensitivity to sound) or other underlying illnesses should consult a doctor before starting treatment.
WARNING Risk of burn injury. Do not use the device during MRI (Magnetic Resonance Imaging) examinations.
WARNING Risk of damage to your skin (irritation or redness from the use of the adapter). It is important to follow the skin hygiene guidelines. Please contact your doctor if you have any concerns. Only use the adapter provided by Duearity and according to this manual.
WARNING Risk of hearing damage. The Device is not to be used by persons under the age of 18 years old.
WARNING The Tinearity™ G1 device contains small parts that may pose a choking hazard to small children. Always keep the charger, the sound generator, and the adapter out of reach of children.
WARNING Check that the cable and connections are not pinched or damaged. Pets and pests may damage the cables’ insulation. Do not use damaged cables.
WARNING The sound generator includes button cell batteries that may be corrosive if swallowed and pose a choking risk to small children. Always keep the sound generator out of reach of children. If a battery is accidentally swallowed, seek medical attention at the nearest emergency department.
WARNING The device should not be stacked on top of itself or placed near other equipment. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally.
WARNING Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or degraded performance and result in improper operation.
WARNING 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 [ME EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
WARNING Risk of hearing damage. If the Tinearity™ G1 device is combined with a hearing aid, the combination needs to be evaluated by a healthcare professional.
WARNING This device is MR unsafe. It must not be brought into an MR environment.

Caution

CAUTION The power source in your sound generator has insufficient energy to cause fire under normal conditions. The sound generator has not been tested for compliance within explosive atmospheres. It is recommended to avoid using your sound generator in areas with danger of explosion.
CAUTION No part of the device should be cleaned under water or in other liquids.
CAUTION The sound generator and the charging station contain electrical parts and should be disposed of as electrical waste.

Contacts

For assistance setting up, using, or maintaining the Tinearity™™ G1 system; or to report unexpected functionality, please find contact information on the back cover of this manual. All product complaints relating to the safety, efficacy, or performance of the device shall be reported immediately to Duearity Americas Inc. by telephone, e-mail, or letter, per the contact information below. All complaints shall be accompanied by the product name, model/part number (as applicable), and lot number (as applicable). The person formulating the complaint shall provide their name, address, and as many details as possible. You may contact Duearity directly according to the contact details available on the back cover of this manual.