DUEARITY Tinearity G1 Treat Tinnitus Using White Noise User Manual

DUEARITY Tinearity G1 Treat Tinnitus Using White Noise

The Tinearity device is intended for relief and for treatment for people suffering from Tinnitus. The device is intended to be used in homes, at work as well as in public environments. Make sure that warnings and cautions related to specific situations mentioned in the “Important information” section are considered. This user manual gives guidance on how to use and maintain your new Tinearity device. Please read through this manual carefully to optimize the use of Tinearity Sound Generator. Pay extra attention to the Warnings section, the cautions and Maintenance. If any questions, contact your country 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 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
Krusegränd 42 D
212 25 Malmö
Sweden
Name and address to the country/region representatives
Duearity AB
Krusegränd 42 D
212 25 Malmö
Sweden

Intended use

Tinearity G1 is a device that generate white noise to relieve and treat patients suffering from tinnitus. The target population is 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.
Maximum output performanceUsers is recommended to get help from an audiologist to establish their audiogram
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. Users suffering from Hyperacusis is contraindicated.

  Possible side effects

The adapter is made up of a plastic holder and a medical grade tape. The tape has an acrylic adhesive that attaches the adapter to the user’s skin. An area of irritation might appear behind the ear from switching the single use adapter.

Useful life / service life

Useful life of the sound generator and the charger is 24 months, calculated from the manufacturing date. Expiration date for the adapter is stated at the label.

Suitability of the treatment

The treatment can require involvement of healthcare professional, if the healthcare professional require 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 your symptoms associated with tinnitus by the use of white noise. The white noise is by the sound generator converted into vibrations that are transmitted via the adapter through the skull to the inner ear. This method works independently of the ear canal and the middle ear and facilitates the treatment to be performed without obstructing your normal hearing canal. Thus, your Tinearity G1 device can be used at all times during the day, during work, during activities as well as 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 include 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.

• The USB cable is included in the packaging and might pose a risk of choking, keep away from small children.

Tinearity G1 description

Device overviewTinearity™ 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 1kHz‐10Khz with a maximum output level of 48dB HL. This device is intended for use during eight (8) hours a day when set at the maximum output level. The sound generator is supplied in pairs, with the intention to be used at both sides of the head. The adapter is a disposable device that serves as a mechanical connector between the sound generator and the user. The adapter is made up of a plastic holder that are compatible with the sound generator and a medical grade tape to be attached to the user’s skin. The adapter is a single use device and is designed to be removed daily after each treatment. The sound generator uses a re‐chargeable battery as a power source which is charged with the charger. The charger consists of a charger plate designed for two sound generators to be charged simultaneously and a separate USB cable with a USB‐C port for connection to the wall socket. The Tinearity G1 sound generator and adapter can be used at all time during the day, during sleep as well as during work and spare time.
CAUTION : The sound generator shall never be cleaned or submerged in or under water or other liquids.

Device description

Sound generator

The sound generator convert white noise into vibrations. It is driven by a re‐chargeable li‐ion battery.
CAUTION : The sound generator contain electrical parts and shall be disposed as electrical waste.
Note : for explanation of the symbols see section 17 “Description of symbols used in this user manual”.
Sound generator

Adapter

The adapter transmit the vibrations generated by the sound generator through the skull to the inner ear.
Illustration of Adapter.

Charger

The charger is used for charging the sound generator. Safety information is labelled at the undersurface of the charger.
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 contain electrical parts and shall be disposed as electrical waste.

 Packaging material

The sound generator and the adapter comes in separate primary package (label illustration),
Primary package label Sound Generator.
Primary package label Adapter. all packed together with the charger, a USB cable and this manual in a customer package. The adapters is also distributed separately, in a customer package.
Customer label Tinearity System.
Customer package label Adapters
Note: for explanation of the symbols see section 17 “Description of symbols used in this user manual”.

 Preparation before first use

• Unpack the parts, check visually for any damages and follow the cleaning instructions for the sound generator and charger according to section 10.2 and 10.3.
• Check safety‐ elated labeling on the Tinearity G1 devices for legibility.
• Make sure that your power supply (not supplied in the package) for connecting the charger into the wall socket is the following performances:
  • USB‐A port, 5V DC, min 1000mA, Max 1500mA
  • Double insulated
  • CE marked
• Charge the sound generators completely, using the supplied charger, see section 11.

Preparation before every use

 Skin hygiene

The skin behind the ear must be clean, dry and free from hair. If the hairless area is not large enough, adjust the hairline with a razor.
Clean the skin with mild soap and let it dry completely before you apply the adapter.

Sound generator and Adapter

Check the sound generator and the adapter visually before use, for any damage.
WARNING: If covers are damaged or any parts are loose, do not use the device.
Clean the sound generator according to section 11.

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

1.  Locate the area for application of the adapter behind the ear. To maximize the performance of your treatment make sure that the adapter is placed at the mastoid bone and orientated as illustrated in below figure. Make sure that the area is free from hair. Note: the adapter has a single curvature designed to be follow the curvature behind the ear, therefore correct rotation on the application of adapter is advised to ensure a good adhesion.
   Correct application, the soft part is applied closest to the ear. In‐correct application, rotate the adapter 180 degrees relative your skull. In‐correct application, rotate the adapter 90 degrees relative 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.

2.  Hold the adapter in the wings.

3. Remove the protective film, do not touch  the adhesive surface.

4. Press gently on the highlighted surface of the adapter for at least 20 seconds.

WARNING : Risk for skin damage. Only use the adapter provided by Duearity and according to this manual.

Connecting the Sound generator
To safely and comfortably connect the sound generator to the adapter, tilt it slightly and carefully push it onto 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 will turn your sound generator on and a longer press will turn your sound generator off.
Note: use a short press to turn your device on, a long press will turn your device off.

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

•  Turn the volume up by pressing the button marked with “+”
•  Turn the volume down by pressing the button marked with “‐“

Treatment
Use your sound generator for 8h each day. The total treatment period shall not exceed 24 months.
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 the sound generator and firmly pressing the wing handle furthest away from the ear on the adapter. The sound generator will now 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 from the skin. The adapter shall be removed after each use. It is for single‐use only.
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 protected from dust, dirt and sunlight when you do not use the device. Before each use, follow these cleaning instructions.
Note : Your sound generator is protected against ingress of water but is not waterproof.

Preparation for cleaning

•  Separate your sound generator from the adapter.
•  Secure that 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

Clean your sound generator on the outside with soft detergent wipes, as minimum every 7 days, the duration of the cleaning action shall be minimum 1 minute. Make sure to reach all sides, gaps and ridges. The level of cleaning shall be as minimum equivalent to general personal grooming items.
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.

• The sound generator shall never be cleaned or submerged in or under water or other liquids.

Cleaning the Charger

Clean your charger on the outside with soft detergent wipes, as minimum every 7 days, the duration of the cleaning action shall be minimum 1 minute . Make sure to reach all sides, gaps and ridges . The level of cleaning shall be as minimum equivalent to general personal grooming items.
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 driven by a Li‐Ion battery. The sound generator is rechargeable and have an operating period of maximum 12 hours, depending on the used amplitude level.

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 23.
•  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 will be prolonged, but not entirely stopped in order to prevent damaging the battery or overheating, respectively.
•  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 device is not functioning properly, please visit your My Page and follow the instructions. If you need to order an additional set of adapters, please visit your My Page and follow the instructions.

Technical description

Trouble shooting

Symptom| Explanation| Possible Cause| Proposed action
---|---|---|---
No white noise is perceived.| 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 9.4.
No white noise is perceived.| The batteries must be charged after each use.| The batteries are discharged.| Charge your sound generator, see section 11.
The sound generator falls of from the adapter.| __ The adapter is worn.| The adapter is single use.| Change adapter, see section 9.1 and 9.7.

__ Technical data

Environmental conditions| Sound generator| Inductive charger
---|---|---
Ambient air pressure
Operation| 700 hPa to 1060 hPa
Transport/ storage
Ambient temperature
Operation| +5 to +35 C
Transport and storage| ‐25 to +70 C
Ambient humidity
Operation| RH 15% to 93% , non condensing
Transport and storage
Operational altitude| Max 3000 m over see level
Classification
Class| II| III
Applied part category| BF| Non
Protection of harmful ingress| IP 22| IP 21
Pollution degree| __ II| II
Mode of operation| Continous use| Continous use
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.

 EMC information

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 IEC 61000‐3‐2| Sound generator: Not applicable, battery operated device
Charger: Not applicable, P < 75W
Voltage fluctuations / flicker emissions IEC 61000‐3‐3| Sound generator: Not applicable, battery operated device
Charger: Not applicable, P < 75W
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| 61000‐4‐2| ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields| 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| 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
Surges| 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| 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| 61000‐4‐8| 30 A/m
50 Hz
Voltage dips| 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| IEC 61000‐4‐11| Sound generator: Not applicable, battery operated device
| | Charger 0% UT, 250 cycles at 0°
---|---|---

Manufacturer’s 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 national legislation governing the sale of consumer goods.

Important information

Warnings

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

•  Risk of electrocution. Your Sound processor has achieved IP 22 classification and is
  referred as water‐resistant, not water‐proof. Always remove your Sound processor before showering or bathing.

• Risk of electrocution. Use cables, chargers, adapters and sound generators provided by the manufacturer, ONLY.

•  Risk of body damage. Never expose your Tinerity G1 device for extreme heat, do not dry the device in microwave or other ovens.

• Risk of electrocution 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

• Risk of infection. This device is to be used by one user and shall not be reused by  several individuals

•  Risk of fire and hazardous smoke. Do not use in an Oxygen rich environment or in areas with flammable gases.

• Risk of affecting measurement results and treatment results. This device emits electromagnetic radiation, do not use closer than 30 cm from other medical devices.

• Risk of hearing damage. Patient suffering from Hyperacusis (sound over sensitive) or other underlaying illnesses shall consult physician before treatment is started.

•  Risk of burn injury. Do not use during MRI (Magnetic Resonance Imaging) examination.

•  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.

•  Risk for hearing damage. The Device is not to be used by persons under the age of 18  years old.

•  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.

• Check the cable and connections for pinching or damage. Pets and pests may damage the insulation of the cables. Do not use damaged cables.

•  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.

• 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.

• 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.

• 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.

•  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.

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 processor in areas with danger of explosion.
• No part of the device shall be cleaned in or under water or other liquids.
•  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.

Description of symbols used in this user manual

directives. The four digit number indicates the identification of the notified body
| Manufacturer| The device is produced by the manufacturer whose name and address are stated next to the symbol.
| Use‐by‐date| Indicate the date after which the device is not to be used.
| Batch code| Indicates the manufacturer’s batch code so that the batch or lot can be identified.
| Catalogue number| Indicates the manufacturer’s catalogue number so that the medical device can be identified.
| Serial number| Indicates the manufacturer’s serial number so that a specific medical device can be identified.
| Country of manufacturer| Identifies the country of manufacture of products.
| Do not use if package is damage and consult instructions for use| Indicates that the device should not be used if the package has been damaged or opened and that the user should consult the instructions for use (user manual) for additional information.
| Fragile, handle with care| Indicates a device that can be broken or damaged if not handled carefully.
| Keep dry| Indicates a medical device that needs to be protected from moisture.
| Temperature limitation| Indicates the temperature limits to which the medical device can be safely exposed.
| Humidity limitation| Indicates the Humidity limits to which the medical device can be safely exposed.
| Atmospheric pressure limitation| Indicates the Atmospheric pressure limits to which the medical device can be safely exposed.
---|---|---
| Do not re‐use / Single use| Indicates a device that is intended for one single use only.

| Single patient use| Indicates a device that is intended for one patient only.
| Consult instructions for use or consult electronic instructions for use| Consult instructions for use for warnings and cautions.
| IFU| Consult instructions for use for warnings and cautions.
| Medical Device| The device is a medical device.

| Electronic waste (Weee)| Waste from electronic equipment must be handled according to local regulations.
| Type BF Applied Part| Classification of protection against electrical shock.
IP 21| IP 21| Indicates the class of protections against harmful ingress of water and objects.
IP21 indicates protected from touch by fingers and objects greater than 12 millimeters and vertically falling drops.
IP 22| IP 22| Indicates the class of protections against harmful ingress of water.
IP 22 protects from dripping water, from vertical direction.
| MR Unsafe| The device is not safe in MR environment, i.e., magnetic resonance imaging (magnet camera, MR‐camera), and shall be removed.
Rx ONLY| Prescription device| The device is sold with prescription. Applicable for the US market.

duearity.com

References

• Relieve and alleviate tinnitus on your terms, with Tinearity G1
• Tinnitus | New patented product from Duearity
• Tinnitus | New patented product from Duearity

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