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Regulatory Information

Regulatory Information

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CAUTION:

 

If set to the maximum output level and worn for periods of time 

exceeding the following recommendations, your exposure to sound energy has the 
potential to exceed noise exposure limits. You should not use your hearing device for 
more than sixteen (16) hours a day if your device is set at the maximum output level, 
nor should you use your device if your Miracle-Ear

®

 Hearing Care Professional has set 

the device at levels that exceed your comfort level.

Important Notice for Prospective Sound Generator Users

Good health practice requires that a person with tinnitus have a medical evaluation 
by a licensed physician (preferably a physician who specializes in diseases of the ear) 
before using a sound generator. Licensed physicians who specialize in diseases of the 
ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.

The purpose of a medical evaluation is to assure that all medically treatable 
conditions that may affect tinnitus are identified and treated before the sound 
generator instrument is used.

TINNITUS TECHNICAL DATA

Custom Tinnitus™ Technology Maximum Output = 87 dB SPL (typical) when 
measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.

WIRELESS TECHNICAL DESCRIPTION

Your hearing aids contain a radio transceiver utilizing Bluetooth

®

 Low Energy wireless 

technology operating in the 2.4-2.4835 GHz frequency band with a maximum 
effective radiated power of -4 dBm using GFSK transmission modulation. The receiver 
section of the radio has a bandwidth of 1.5 MHz.

This hearing aid model has been tested to, and has passed, the following emissions 
and immunity tests:
•  IEC 60601-1-2 radiated emissions requirements for a Group 1 Class B device as 

stated in CISPR 11

•  RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as 

well as higher field levels from communications devices as stated in Table 9 of IEC 
60601-1-2

•  Immunity to power frequency magnetic fields at a field level of 30 A/m and 

proximity magnetic fields as stated in Table 11 of IEC 60601-1-2.

• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge
The Miracle-EarCHARGE

 start custom AV charger has been tested to, and has 

passed the following emissions and immunity tests:
•  IEC 60601-1-2 radiated and conducted emissions requirements for a Group 1 Class 

B device as stated in CISPR 11.

•  Harmonic distortion and voltage fluctuations affecting the power input source as 

stated in Table 2 of IEC 60601-1-2.

•  RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as 

well as higher field levels from communications devices as stated in Table 9 of IEC 
60601-1-2.

Summary of Contents for EarENERGY 2 ITC R EV

Page 1: ...www miracle ear com Miracle EarENERGY 5 4 3 2 ITC R EV Rechargeable Custom User Manual...

Page 2: ...rs 19 Memory Change 19 Mute 20 Custom Tinnitus Level Control 20 Directional Settings 20 Telephone Use 20 Custom Tinnitus Technology 23 Adjustment Mobile Phone Use 26 Pairing with an iOS Device 26 Pair...

Page 3: ...battery contact 3 Vent 4 Sound outlet 5 Multifunction button optional 6 Rotary volume control optional Your hearing aid can be identified by 7 Location of left right side indicator RED is for right e...

Page 4: ...Charger Overview Charger Overview 7 6 Features Controls and Identification 1 Cleaning Brush 2 Charging Posts 3 Hearing Aid Charging LEDs 4 Power Supply Port Power Cord 2 3 1 4...

Page 5: ...ts charging port post for three seconds and then re insert it LEDs illuminate for 10 seconds before turning off The LEDs corresponding to each hearing aid Glowing Green Charging Solid Green Fully Char...

Page 6: ...g aid with your thumb and forefinger gently rotate it as you pull outward For hearing aids with removal handle grasp removal handle and gently remove from ear 1 2 Helpful Hints Minor irritation and or...

Page 7: ...ring aid on a flat stable surface e g a table with the tip facing upwards and it will go into a low powered state after about 15 minutes To resume normal hearing aid function pick up your hearing aid...

Page 8: ...nts Upon activation your hearing aids use an environmental scan to bring comfort and clarity Ask your Miracle Ear Hearing Care Professional for more information Assigned User Control Settings Short Pr...

Page 9: ...direction either up or down For example a short press and release may increase the volume while a long press and hold may decrease the volume in your hearing aid Some user controls can be set for the...

Page 10: ...cators An indicator will sound when the battery voltage is low You have approximately 30 minutes of battery life remaining An indicator may also sound just before the battery stops working Memory Chan...

Page 11: ...you effectively communicate on the telephone Ask your hearing professional about your telephone solution My hearing aids have the following telephone setting s Automatic Telephone Memory and Automati...

Page 12: ...ed as part of a tinnitus treatment program Custom Tinnitus Technology plays a tinnitus stimulus through the hearing aid The tinnitus stimulus is programmed according to your hearing loss and your Mira...

Page 13: ...to decrease stimulus level Ask your Miracle Ear Hearing Care Professional if this setting would benefit you Rotary Tinnitus Stimulus Control Your hearing aid may be equipped with a rotary user contro...

Page 14: ...your iOS device Within the Settings menu go to Bluetooth and toggle to On 2 Turn your hearing aids off and back on This puts the hearing aids in pairing mode 3 Within the Settings menu go to Accessibi...

Page 15: ...ase volume for each hearing aid individually Turn off Adjust Independently to make changes to both hearing aids simultaneously Normal indicates the name of a memory setting in the hearing aid You can...

Page 16: ...with your Miracle Ear Hearing Care Professional to determine which accessories may be best for you Hearing Aid Care Keep your hearing aid clean at all times Heat moisture and foreign substances can re...

Page 17: ...easily find them Safely out of reach from children and pets Charger Care Keep your charger clean Heat moisture and foreign materials can result in poor performance Using the provided cleaning brush k...

Page 18: ...g aid receiver When you need to replace your wax guards please follow these instructions 1 Insert empty end of the application stick straight into used wax guard in hearing aid 2 Pull straight out do...

Page 19: ...the microphone from wax and debris Your Miracle Ear Hearing Care Professional will instruct you on maintenance of the microphone cover Service and Repair If for any reason your hearing aid does not o...

Page 20: ...icator when hearing aids are inserted into the charging port post Incorrect hearing aid orientation Reposition your hearing aids in the charging port post Charger is not plugged into an external power...

Page 21: ...ee seconds to turn off Your Miracle Ear Hearing Care Professional will recommend an appropriate schedule to help you adapt to your new hearing aid It will take practice time and patience for your brai...

Page 22: ...s appropriate to treat hearing losses ranging from mild to profound Your Miracle EarENERGY 5 4 3 2 ITC R EV is designed to operate in public and residential environments and are designed to comply wit...

Page 23: ...to a shock hazard please send in for repair Keep out of reach from children Do not ingest anything in the package including desiccant cleaning tool etc Any cords and AC adapters must be approved or l...

Page 24: ...drops such as condensation Do not connect the Miracle EarENERGY 5 4 3 2 ITC R EV to any devices not described in this manual The service life of the Miracle Ear Charger is 3 years Required Hearing Ai...

Page 25: ...who have obtained a medical evaluation from a licensed physician Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal belie...

Page 26: ...ed the Custom Tinnitus Technology generates the sound and allows a patient s Miracle Ear Hearing Care Professional to design and program appropriate settings for an individually prescribed sound treat...

Page 27: ...by or on the order of a doctor audiologist or other hearing care professional licensed to dispense hearing aids in your state The use of any sound generating tinnitus therapy device should be only on...

Page 28: ...8 7 WIRELESS TECHNICAL DESCRIPTION Your hearing aids contain a radio transceiver utilizing Bluetooth Low Energy wireless technology operating in the 2 4 2 4835 GHz frequency band with a maximum effect...

Page 29: ...voltage dips and interruptions on the power input as stated in Table 6 of IEC 60601 1 2 REGULATORY NOTICES FCC ID EOA 24LIVIOITEL left EOA 24LIVIOITER right IC 6903A 24LIVIOITEL left 6903A 24LIVIOITER...

Page 30: ...idity Limitation BS EN ISO 15223 1 2021 5 3 8 Caution BS EN ISO 15223 1 2021 5 4 4 General warning sign EC 60601 1 Reference no Table D 2 Safety sign 2 ISO 7010 W001 Refer to user manual EC 60601 1 Re...

Page 31: ...and your local community laws may require that your hearing aids and charger be disposed of via your local electronics recycling disposal process The instructions below are provided for the benefit o...

Page 32: ...www miracle ear com Miracle EarENERGY 5 4 3 2 ITC R EV Gu a del usuario para productos hechos a medida...

Page 33: ...s de pila 19 Cambio de memoria 19 Silenciar 20 Aud fono Cargador hecho a medida Control de nivel de Custom Tinnitus 20 Ajustes direccionales 21 Uso del tel fono 21 Tecnolog a Custom Tinnitus 24 Config...

Page 34: ...a recargable 3 Ventilaci n 4 Salida de sonido 5 Bot n multifunci n opcional 6 Control del volumen giratorio opcional Puede identificar el aud fono mediante 7 Ubicaci n del n mero de serie ROJO es para...

Page 35: ...Visi n general del Cargador Visi n general del Cargador 7 6 Funciones controles e identificaci n 1 Cepillo de limpieza 2 Puertos de carga 3 LED de carga de aud fonos 4 Puerto microUSB 2 3 1 4...

Page 36: ...erlos en el cargador despu s de estar completamente cargados y en el momento que no los est utilizando Si no va a usar los aud fonos durante un per odo prolongado de tiempo por ejemplo semanas retire...

Page 37: ...a bajo Cuando se carga la pila incorporada con el cable suministrado los cuatro LED Glowing while charging Solid when charged Inserci n y remoci n Para insertar el aud fono 1 Sujete el aud fono con el...

Page 38: ...cenderlo Sigue habiendo una demora para darle tiempo a insertar el aud fono en el o do APAGADO Los aud fonos se apagar n autom ticamente cuando se coloquen en los puertos de carga El proceso de carga...

Page 39: ...ea compatible con un control de usuario adicional Este control puede ser configurado por su profesional de la audici n Una vez configurado y mientras el aud fono est en el o do basta con dar dos toque...

Page 40: ...aumente Subir bajar el control del volumen Si el control de usuario est configurado para subir bajar espec ficamente el control del volumen cada vez que se active el control de usuario el volumen de s...

Page 41: ...control Control de volumen Presionar y soltar Control de volumen Presionar y sostener Indicadores de pila Un indicador sonar cuando el voltaje de pila est bajo Tendr aproximadamente 30 minutos de dura...

Page 42: ...mulo Custom Tinnitus Consulte la secci n etiquetada como Tecnolog a Custom Tinnitus p gina 25 para m s informaci n Ajustes direccionales Su aud fono puede tener un micr fono direccional para ayudar a...

Page 43: ...ticamente a la memoria del tel fono si est habilitada Memoria tel fono manual y Telebobina manual El acceso manual le permite cambiar los aud fonos a una memoria de tel fono o telebobina seg n sea nec...

Page 44: ...l de usuario hasta que se alcance el volumen deseado NOTA Si pasan 10 minutos o m s desde el ltimo cambio de nivel de est mulo el nivel disminuir autom ticamente antes de que aumente Subir bajar el co...

Page 45: ...ra direccionar el audio llamadas y multimedia desde su tel fono inteligente a los aud fonos Emparejar el aud fono con un dispositivo iOS Para ajustar sus aud fonos con su dispositivo iOS debe empareja...

Page 46: ...scuchar en vivo para transmitir la entrada del micr fono del dispositivo iOS directamente en su aud fono Dirija el micr fono del dispositivo iOS hacia la fuente de audio Para minimizar el ruido de fon...

Page 47: ...directamente a sus aud fonos Consulte con su profesional de la audici n para determinar qu accesorios pueden ser los mejores para usted Cuidado del aud fono Mantenga sus aud fonos limpios en todo mom...

Page 48: ...impio El calor la humedad y las sustancias extra as pueden provocar un rendimiento deficiente Mantenga los puertos de carga libres de residuos empleando el cepillo de limpieza suministrado No utilice...

Page 49: ...afuera sin girar para quitar la barra y desecharla Cubierta adaptada del micr fono La cubierta adaptada del micr fono sirve para proteger el micr fono de residuos de cera y otros restos Su profesiona...

Page 50: ...mience el proceso de carga y a continuaci n ret relo Esto inicia un ciclo de alimentaci n de sus aud fonos Molde tubo adaptador obstruidos Limpie o sustituya el molde seg n proceda Gu a para la soluci...

Page 51: ...orriente de pared Conecte el cable de alimentaci n a su cargador y con ctelo a una fuente de alimentaci n externa por ejemplo un tomacorriente de pared Los LED de carga del aud fono se encender n dura...

Page 52: ...a la fuente de alimentaci n Si no es as p ngase en contacto con su profesional de la audici n Su profesional de la audici n le recomendar un programa apropiado para ayudarle a adaptarse a su nuevo aud...

Page 53: ...os aud fonos est n disponibles con varios niveles de salida ganancia apropiados para tratar las p rdidas auditivas que van de leve a profunda Los aud fonos est n dise ados para cumplir con las normati...

Page 54: ...be estar homologado o indicado por un laboratorio de pruebas reconocido a nivel nacional Uso en aeronaves El uso de las capacidades inal mbricas opcionales que pueden ser funciones destacadas en sus a...

Page 55: ...de p rdida repentina de audici n de r pida progresi n o en los 90 d as anteriores iv Mareos agudos o cr nicos v P rdida auditiva unilateral de reciente aparici n s bita o en los 90 d as anteriores vi...

Page 56: ...r un aud fono cuyo nivel de presi n ac stica m xima supere los 132 decibelios ya que puede existir el riesgo de perjudicar la audici n que le queda al usuario del aud fono Algunos usuarios de aud fono...

Page 57: ...ancha de ruido blanco que var a en frecuencia y amplitud Estas caracter sticas son ajustables por el profesional de la audici n y son espec ficos de la terapia prescrita por el profesional dise ado p...

Page 58: ...ngan la prescripci n m dica pertinente de un doctor audi logo u otro profesional de la audici n con autorizaci n para suministrar aud fonos en su regi n El uso de otros dispositivos generadores de rui...

Page 59: ...dicamente tratables que puedan afectar al tinnitus est n identificadas y tratadas antes de utilizar el instrumento generador de sonido FICHA T CNICA SOBRE EL TINNITUS Tecnolog a Custom Tinnitus Salid...

Page 60: ...or conducci n inducidas por los campos de RF en la entrada de alimentaci n como se indica en la Tabla 6 de la norma IEC 60601 1 2 Inmunidad a las interrupciones y ca das de tensi n en la entrada de al...

Page 61: ...15223 1 2021 5 3 8 Precauci n BS EN ISO 15223 1 2021 5 4 4 Se al de advertencia general CE 60601 1 N referencia Tabla D 2 Se al seguridad 2 ISO 7010 W001 Consulte el manual folleto de instrucciones C...

Page 62: ...os Las instrucciones siguientes se proporcionan para el personal encargado de la eliminaci n reciclaje Incluya este manual cuando deseche sus aud fonos y o el cargador PARA EL PERSONAL DE ELIMINACI N...

Page 63: ...t Suite 2300 Minneapolis MN 55402 www miracle ear com The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks is under license All trade names...

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