DUEARITY Tinearity G1 Tinnitus System User Manual

: June 16, 2024
: DUEARITY

DUEARITY Tinearity G1 Tinnitus System

Product Information

Specifications

Model: REF 6000, TinearityTM G1
Date of Issue: 2024-04-14
Manufacturer: Prime Health Distribution Ltd
Intended Use: Relieve and treat symptoms of tinnitus
Target Population: Adult population over 18 years of age
Treatment Time: 8 hours per day for 6-24 months
Useful Lifespan: 24 months from the manufacturing date

Product Usage Instructions

1. Introduction

The Tinearity G1 is designed to generate white noise to relieve and treat tinnitus symptoms. The device is intended for adult users over 18 years of age.

2. How to Use

Ensure the device is fully charged before initial use.
Place the device on the ear with the plastic holder and medical tape securely fastened.
Turn on the device and adjust the volume to a comfortable level.
Use the device for 8 hours per day for the recommended treatment duration.

3. Maintenance

Replace the disposable adapter as indicated on the label when necessary. Clean the device regularly with a soft, dry cloth to remove any dirt or debris.

4. Safety Precautions

Pay attention to warning symbols in the manual.
If you experience irritation or adverse effects, discontinue use and consult a healthcare professional.
Do not use the device if you have moderate or severe hearing loss.

Frequently Asked Questions

Q: How long should I use the Tinearity G1 per day?
- A: The recommended treatment time is 8 hours per day for 6-24 months.
Q: What should I do if I experience irritation behind the ear?
- A: If irritation occurs, stop using the device and consult your healthcare professional.

The User Manual

The Tinearity 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.

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 environment or properties.
Note Indicating useful information about the safe use of the device.

Introduction

Model REF: 6000, TinearityTM G1

Name and address to the manufacturer

Duearity AB
Höjdrodergatan 21
212 39 Malmö
Sweden

Name and address to the UK Distributor

Prime Health Distribution Ltd
20 Wenlock Rd
London, N1 7GU
England

Intended use

Tinearity G1 is a device that generates white noise to relieve and treat patients suffering from tinnitus. The target population is the adult population over 18 years of age.

Note The patient is the intended operator of the device.

Indications for use

Intended medical indication

Tinearity G1 is intended to treat and relieve Tinnitus in users with normal hearing or mild hearing loss. Tinearity G1 have a performance output as shown in diagram 1. Users is recommended to get help from an audiologist to establish their audiogram.

Diagram 1. Maximum output performance

The recommended treatment time is 8 hours per day for 6-24 months.

Contraindications

Users with moderate and severe hearing loss is contraindicated, i.e., hearing threshold level above 40dB HL. The device is NOT intended for users suffering from moderate and severe 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 users 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.

Suitability of the treatment

The treatment can require the involvement of a healthcare professional, if the healthcare professional requires information regarding the suitability of the treatment, further information can be obtained by contacting the manufacturer.

System Overview

Your Tinearity G1 device is designed to relief 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 shall never be cleaned or submerged in or under water or other liquids.

Packaging content

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

Note The Power supply for connection of the charger to the wall socket is not included in the packaging, see section technical data.
WARNING The Tinearity G1 device includes small parts that may be an asphyxiation risk for small children. Always keep the charger station, the sound generator and the adapter out of reach for children.
WARNING The USB cable is included in the packaging and might pose a risk of choking, keep away from small children.

Tinearity G1 description

Tinearity G1 comprises three components: (1) the sound generator, (2) adapters and (3) a charger (including a USB cable for connection to a power supply). The sound generator is attached to the skin behind the ear by means of the adapter. The sound generator works within the frequency span of 700 Hz-10Khz with a maximum output level of 48dB HL. The sound generator is supplied in pairs, with the intention of being used behind both ears. The adapter consists of a plastic holder compatible with the sound generator and a medical 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 shall never be cleaned or submerged in or under water or 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 an explanation of the symbols, see section 17

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

Charger

The charger is used for charging the sound generator. Safety information marked on the underside of the charger.

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 material

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. The adapters are also distributed separately, in a customer package

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 sections 10.2 and 10.3. Check the safety-related labeling on the Tinearity G1 devices for legibility. Make sure that the power supply (not supplied in the package) for connecting the charger into the wall outlet has the following performance:

USB-A port, 5V DC, min 1000mA, Max 1500mA
Double insulated
CE marked

Fully charge the sound generators using the supplied charger, see section charging the batteries / sound generator, see section 11.

Preparation before every use

Skin hygiene

The skin behind the ear must be clean, dry 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, prior to use
WARNING If covers are damaged or any parts are loose, do not use the device. Clean the sound generator according to section 10.

Charger

Place the device on a flat surface.

WARNING Check the cable and connections for pinching or damage. 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 oriented as illustrated in the figure below. Make sure that the area is free from hair.
- √ Figure 10. Correct application: the soft part is applied closest to the ear
- χ Figure 11. Incorrect application; rotate the adapter approx. 90 degrees relative to your skull.
- Note Transfer of sound/noise through Bone conduction is most effective if the adapter is attached to the skin where the tissue thickness is minimized.
- 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 and do not touch the adhesive surface.
Gently Press on the highlighted surface of the adapter for at least 20 seconds. Figure 14.

WARNING Risk for 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.

Adjust the volume

Adjust the volume until you feel a relief from your tinnitus noise.

Increase the volume by pressing the button marked with +
Decrease the volume by pressing the button marked with –

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

Your sound generator can be used for instant relief (masking) or as the sound source during the management of tinnitus (treatment).

For masking your tinnitus, adjust the volume until you feel a relief.
For management of tinnitus, adjust the volume just below your tinnitus sound. Use the device for 6-8h each day.

We recommend you consult a healthcare professional for individual adjustments.

WARNING Risk of hearing damage. If you perceive discomfort or if your tinnitus is getting worse, immediately abort the treatment and consult a healthcare professional

Remove the Sound generator

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

CAUTION Risk of damage to the device, charge the transducer 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 as plastic waste

Maintenance

Store your Tinearity G1 device in room temperature environment protected from dust, dirt and sunlight. Before each use, clean your device as follows. Note Your sound generator is protected against 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 shall never be cleaned or submerged in or under water or other liquids.
CAUTION The charger shall never be cleaned in or under water or 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 shall be re-charged after each use.

WARNING The sound generator include 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 below steps:
Make sure that the Charger is placed in a room that has a temperature of maximum 35 C
Place your sound generator(s) with the front side (indicated with the Duearity symbol) facing the inductive charger, see figure 21.
The blinking green light indicates that the device is charging.
Let the sound generator(s) charge until the indicator(s) stops blinking. A complete charge cycle is approximately 6 hours. If the battery is fully discharged or if the ambient temperature exceeds 30 degC 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, Risk of 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.

Technical description

Trouble shooting

Technical data

Requirement for AC/ DC adapter

EMC information

Table 4

Electromagnetic Emissions

The Tinearity 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 Tinearity system should assure that they are used in such environment.

Emission Tests| Compliance
Radiated and conducted RF emissions EN55011/CISPR 11| Sound Generator: Class B, Group 1 Charger: Class B, Group 2

__

Electromagnetic environment – guidance

The Tinearity 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 system is intended for use in the electromagnetic environment specified below. The customer or the user of Tinearity system should assure that they are used in such 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,

| __

28

| | | LTE Band 1, 3,

4, 25, UMTS

|
---|---|---|---|---

2450

| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450,

LTE Band 7

|

28

5240

5500

5785

| WLAN 801.11

a/n

|

9

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

Conducted disturbances| EN IEC 61000-4-

6

| Sound generator: Not applicable, battery operated device

Charger: Tested through generic AC/DC adapter

3 V/m

0,15 MHz 80 MHz

6 V/m in ISM bands

80 % AM at 1 kHz

| 3 V/m

0,15 MHz 80 MHz

6 V/m in ISM and amateur radio bands 80 % AM at 1 kHz

Rated power frequency magnetic

fields

| EN IEC 61000-4-

8

| 30 A/m

50 Hz

Voltage dips| EN IEC 61000-4-

11

| Sound generator: Not applicable, battery operated device

Charger: Tested through generic AC/DC adapter 0% UT, 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°,

270°, 315°

0% UT, 1 cycle at 0°

70% UT, 25 cycles at 0°

Voltage interruptions| EN IEC 61000-4-

11

| Sound generator: Not applicable, battery operated device

Charger 0% UT, 250 cycles at 0°

Manufacturers warranty

Duearity sound generators and inductive chargers are covered by a limited warranty issued by the manufacturer. The warranty period is 24 months from the date of delivery. This limited warranty covers manufacturing and material defects in the sound generator or charger itself. 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. The above warranty does not affect any legal rights that you might have under applicable nationallegislation governing the sale of consumer goods

Important information

Warnings

WARNING Risk of hearing damage. If you perceive discomfort or if your tinnitus is getting worse, immediately abort the treatment and consult a healthcare professional.
WARNING Risk of electric chock. Your Sound generator has achieved IP 22 classification and is referred as water-resistant, not water-proof. Always remove your Sound generator before showering or bathing.
WARNING Risk of electric chock. Use cables, chargers, adapters and sound generators provided by the manufacturer, ONLY.
WARNING Risk of body damage. Never expose your Tinearity G1 device for extreme heat, do not dry the device in microwave or other ovens.
WARNING Risk of electric chock or burns,
Do not open the device
Do not use device if the enclosure or cable is damaged
Do not service or repair the device
No modification of this equipment is allowed
Only use power supply that fulfills the specification in this instruction
WARNING Risk of infection. This device is to be used by one user and shall not be reused byseveral individuals
WARNING Risk of fire and hazardous smoke. Do not use in an Oxygen rich environment or in areas with flammable gases.
WARNING Risk of affecting measurement results and treatment results. This device emitselectromagnetic radiation, do not use closer than 30 cm from other medical devices.
WARNING Risk of hearing damage. Patient suffering from Hyperacusis (sound over sensitive) or other underlaying illnesses shall consult physician before treatment is started.
WARNING Risk of burn injury. Do not use during MRI (Magnetic Resonance Imaging) examination.
WARNING Risk for 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 local general practitioner if you have any concerns. Only use the adapter provided by Duearity and according to this manual.
WARNING Risk for hearing damage. The Device is not to be used by persons under the age of18 years old.
WARNING The Tinearity G1 device include small parts that may be an asphyxiation risk for small children. Always keep the charger, the sound generator and the adapter out of reach for children.
WARNING Check the cable and connections for pinching or damage. Pets and pests maydamage the insulation of the cables. Do not use damaged cables.
WARNING The sound generator include 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 nearestemergency department.
WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment 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 for hearing damage. If the Tinearity G1 device is combined with a hearing aid, the combination needs to be evaluated by a health care 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 of use. The sound generator has not been tested for compliance \with international standards concerning explosive atmospheres. It is recommended not to use your sound generator in areas with danger of explosion.
CAUTION No part of the device shall be cleaned in or under water or other liquids.
CAUTION The sound generator and the charging station contain electrical parts and shall be disposed as electrical waste.

Contacts

For assistance, if needed, in setting up, using or maintaining the Tinearity system; or to report unexpected operation or events, please find contact information, depending on your location, at www.Duearity.com If any serious incident has occurred in relation to the device it shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established