Earlens Photon Скачать руководство пользователя

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IFU00022vJ

Caution: Federal
law restricts this
device to sale by or
on the order of a
(licensed healthcare
practitioner)

FDA Final

Rule

81 FR

38911

Serial number

ISO 15223-

1:2012,5.1.7

Humidity limitation

ISO 15223-

1:2012,

5.3.8

Caution

ISO 15223-1:2012,

5.4.4

Class 1 laser
product

IEC 60825-

1:2007, 5.2

MR unsafe

ASTM F2503-13

Batch code

ISO 15223-

1:2012,

5.1.5

FCC Part 18
Declaration of
Conformity

FCC Guidelines for

Labeling, Part 18,

2014

Catalog code

ISO 15223-

1:2012,

5.1.6

0459

CE conformity
marking

MDD 93/42/EEC,

Annex XII

Date of
manufacture

ISO 15223-

1:2012,

5.1.3

Type BF applied part

IEC 60601-1:2005

IEC 60417-5333

Non-ionizing
radiation

IEC 60601-

1-2:2007

IEC 60417-

5140 (2003-

04)

14. Laser Certification

The Earlens Light-Driven Hearing Aid complies with 21CFR 1040.10 and 1040.11.

Manufactured by (Ref. ISO 15223-1:2012, 5.1.1):

Earlens Corporation.
4045A Campbell Ave.
Menlo Park, CA 94025

European Authorized Representative (Ref. ISO 15223-1:2012, 5.1.2):

Medimark® Europe SARL
11, Rue Emile Zola, B.P. 2332
F-38033 Grenoble Cedex 2 – France

0459

©2017 Earlens Corp. All rights reserved.

Earlens Photon

and the Earlens Control app are compatible with the following Apple devices: iPhone 7

Plus, iPhone 7, iPhone SE, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c,

Содержание Photon

Страница 1: ...ations 3 6 Warnings 4 7 Precautions 4 8 Clinical Study Results 5 9 Operating Instructions 7 10 Wireless Connectivity Made for iPhone Feature 28 11 Operating Specifications 32 12 Glossary of Terms 35 13 Graphic Symbols Contained in Device Labeling 35 14 Laser Certification 36 Wireless Earlens Light Driven Hearing Aid Hearing Professional Instructions ...

Страница 2: ...rained physician It is placed at the end of the ear canal on the skin around the TM 2 2 Photon Processor and Light Tip The Processor is directly connected to the Light Tip via the cable Figure 3 The Processor is designed to pick up sounds via the microphones apply signal processing and transmit the signal via the cable to the Light Tip The Processor should be placed in the Charger for recharging e...

Страница 3: ... of amplification that includes 125 Hz 10 000 Hz 4 Fitting Range The Earlens Light Driven Hearing Aid provides the full spectrum of amplification that includes 125 Hz 10 000 Hz The audiometric fitting range for the Earlens Hearing Aid is shown in Figure 6 5 Contraindications The patient must not have any known or active medical issues that would preclude having a hearing device including a an abno...

Страница 4: ...ring Aid Keep all components of the Earlens Hearing Aid out of the reach of children pets and others to avoid risk of swallowing Do not incinerate any component of the Earlens Hearing Aid or use near open flame Handle waste from electronic equipment per local regulations 7 Precautions Before using the Earlens Hearing Aid make sure you and your patients read and understand each of the following saf...

Страница 5: ...further concerns they should remove the Processors and contact their hearing professional 8 Clinical Study Results The Definitive Clinical Study of the Earlens Light Driven Hearing Aid confirmed the safety and effectiveness of the Earlens Light Driven Hearing Aid for individuals with a mild to severe sensorineural hearing impairment between the frequencies of 125 Hz 10 000 Hz The prospective singl...

Страница 6: ...ent functional gain in thresholds over the range of frequencies from 2 000 to 10 000 Hz for aided measured at 30 days post placement when compared to unaided measured prior to placement Mean functional gain was 30 5 dB p 0 0001 indicating that the Earlens Hearing Aid was able to deliver significant functional gain Figure 8 Functional gain reached a maximum of 68 dB at 9 10 kHz An additional measur...

Страница 7: ...the impression procedure 4 AEs or the inspection process pre impression 2 AE Two of the related AEs were attributed to Light Tip fit and both were resolved after Light Tip modification One subject continues to report a sensation of fullness Driven on the results of the Definitive study the Earlens Hearing Aid has been shown to be safe and effective in delivering the full spectrum of amplification ...

Страница 8: ...t it is on but unable to communicate with ELF software Factory Restore Restores a Processor to manufacture default settings erasing all fitting and data log information from the Processor Update ELF Software Initiates an ELF software update when one is available Help Help Additional functionality coming soon About Provides information regarding the ELF software version and if an update is availabl...

Страница 9: ...ettings run feedback measurement and display aided threshold data Figure 11 Select Simulation to simulate software without live Processors Select Detect to connect Processors Start Fitting to begin session Figure 10 Start screen Select to begin Measure Light Calibration Run Feedback Measurement View Earlens and or conventional aided sound field thresholds 10 kHz threshold entry blue box Figure 11 ...

Страница 10: ...ization Figure 13 and modify feature settings Figure 14 Figure 13 Fitting screen Fine Tuning Acclimatization tab Select and or change program Change display Output or Gain Copy program Binaural programming link Increase or decrease gain Fitting Data Tab Acclimatization Tab Figure 12 Fitting screen Fine Tuning Data Tab ...

Страница 11: ...or customize alert settings and enable Volume Learning Figure 15 Via drop down menu adjust noise reduction feature settings directional microphone modes and feedback cancellation settings and streaming mic settings Figure 14 Fitting screen Features Figure 15 User Controls screen ...

Страница 12: ...TE Read Processor option must be selected to obtain data logging information Summary View the summary of the fitting session enter session notes print Patient Instructions and print Audiologist Report Figure 17 Figure 16 Data Logging screen Figure 17 Summary screen ...

Страница 13: ...ning The Processor tracks and remembers volume control changes made by the patient and gradually changes the preferred volume level over time Off default On Feature Description Options Background Noise Reduction Intended to reduce background noise without reducing speech levels Off mild moderate strong Impulse Noise Reduction Designed to reduce gain in the presence of sudden loud noises Off On Win...

Страница 14: ...y connect one Processor 1 Connect to Processors To perform programming a HI PRO 2 must be used with cables provided by Earlens a Turn the Processors on by pressing and holding any user control for 3 seconds b Remove the Processor cover to expose the programming port see Figure 35a for removal instructions c Connect the Processors to the HI PRO 2 using programming cables Figure 18 d Open Noah and s...

Страница 15: ...st be completed in order to program the Processor To measure Light Calibration complete the following steps a Select Measure Light Calibration in the Initial Fit screen b A Light Calibration pop up window will appear Figure 22 c Find the patient s threshold at each frequency by presenting a tone Tones can be presented in two ways On Click Selecting the Play tone button or by pressing the space bar...

Страница 16: ...3 c Once measured the software will automatically open to the Fitting screen d If the maximum stable gain interacts with the gain prescription feedback limits will automatically be applied to the Current Fit Response Figure 24 NOTE Gain can be increased beyond the feedback limits but may result in the patient experiencing audible feedback Figure 24 Fine Tuning Output Curves displaying feedback lim...

Страница 17: ... all frequencies Experienced User Select 70 gain with an acclimatization rate of 1 level per week for high frequencies NOTE when automatic acclimatization is enabled the acclimatization curve solid orange line is based off of the Current Fit response curve and the Gain to Target value selected This ensures that any gain changes made prior to enabling acclimatization are accounted for once the auto...

Страница 18: ...ional ELF Features Simulation ELF offers a simulation mode in the Start screen that can be used when Processors are not actively connected to the software Figure 26 Once in Simulation mode any screen can be accessed and adjustments can be made as if devices were actively connected NOTE the feedback measurement functionality is disabled in Simulation mode Streaming Program and Streaming Auto Switch...

Страница 19: ...y time 5 In the Fitting screen under Fine Tuning shape the frequency response to enhance the patients streaming sound quality experience NOTE the Auto Switch streaming program can be disabled or assigned to another program Data Logging The data log feature in ELF provides a summary of a patient s device use Data captured includes average daily use time spent in each program battery life data time ...

Страница 20: ...IFU00022vJ 20 Figure 28 Data Logging Screen ...

Страница 21: ... test mode that will allow you to measure the improvement in hearing due to the Earlens Hearing Aid They may hear an increase in the noise floor as expansion is disabled c Select FG Mode under Tools in the Tool Bar d A pop up window will open and display the patient s audiometric values and space to enter aided threshold data Figure 29 e Disconnect the HI PRO 2 cables from the Processors making su...

Страница 22: ... Bar b Manually enter aided audiometric threshold data Figure 30 c View data in Initial Fit screen by clicking on Show Aided Thresholds Figure 31 d View or print the data by going to the Summary screen and selecting Print Patient Instructions Figure 32 Figure 30 FG Mode window Sound Field Threshold Entry Figure 31 Initial Fit screen Show Aided Thresholds ...

Страница 23: ...nu featured in the Tuning tab Figure 33 NOTE Duplicate programs cannot be programed to the Processors A pop up alert will appear if a duplicate program is selected Match to ELF Rx Resets the fitting response back to ELF calculated targets ELF Rx In the Fitting screen under the Tuning tab click Match to ELF Rx If Link Programs is enabled all programs will be reset to ELF Rx if Link Programs is disa...

Страница 24: ... into the Processor 9 4 Removal and Replacement of Processor Case Cover The Processor cover needs to be removed for programming and for the purposes of replacement a Gently pinch the top and bottom of the Processor This will create a small gap between the cover and Processor near the user controls Figure 35a b Using your fingernail or flat tweezers unsnap the cover on each side of the user control...

Страница 25: ...should they go swimming or do an activity that causes the ear canals to fill with water The patient may apply oil up to once per day as needed however the patient should take care not to overfill their ear canals with oil as this may dampen their hearing temporarily 9 6 Processor Functions Battery Life The Processor battery life lasts a minimum of 16 hours and an average of 20 hours on a full char...

Страница 26: ...cessor and Charger are communicating Table 2 details what each indicator light means 9 8 Care Maintenance Storage Store the Earlens Hearing Aid in a clean dry location out of direct sunlight Avoid exposure to excessively high or low temperatures Store the Processor and Light Tip in the Earlens Charger The Earlens Charger is designed to protect the Light Tip and charge the device Processor Battery ...

Страница 27: ...at the Lens is damaged contact Earlens customer service If the Lens is malfunctioning the ENT physician may reposition the Lens remove and reinsert the Lens or remove the Lens Feedback If the patient is experiencing feedback check the position insertion and alignment of the Light Tip Check feedback measurement data in the Gain Curves display located in the Tuning tab in ELF to determine if there i...

Страница 28: ...pple device should start searching for hearing aids Figure 37 4 Once the hearing aids are discovered the First Name Hearing Aid will display Figure 38 5 Tap on the name to connect the left and or right hearing aid to the Apple device 6 A pairing request window will appear for each device Figure 39 select Pair 7 When the devices are paired and connected a black check mark will appear next to your n...

Страница 29: ...r Speaker 4 Select the End icon to disconnect from the call Incoming Call 1 The iPhone will indicate the arrival of an incoming call NOTE If the call is received while streaming media the stream will be interrupted by the call Once the call is ended the stream will resume 2 Select the Accept or Decline icons on the iPhone 3 Select the End icon to disconnect 10 5 Earlens Control Mobile Application ...

Страница 30: ...ome screen 1 Select Home on the bottom navigation bar 2 Depending on the number of Programs stored in the Processor active circular icons will display numbers 1 4 Under each icon the name of the program will display 3 Tap on the desired program The active program will display in orange Live Mic Users can turn the Apple device into a remote microphone that can be used as an assistive device This fe...

Страница 31: ...a Select Settings General Accessibility Hearing Devices b Select the blue I icon c Select Forget this device d A window will appear select Forget e Proceed with instructions for Pairing and Connecting to Your Apple Device Audio Not Streaming to Hearing Aids If audio fails to stream through the hearing aids perform the following actions 1 Verify that the Bluetooth is enabled on your Apple device 2 ...

Страница 32: ...ars o Light Tip one year o Lens one year The Earlens Hearing Aid is designed for continuous use The Processor features an IP57 rating 11 1 Approximate Dimensions and Weight Component Dimensions Weight Lens 15 x 5 x 10mm 135mg Processor 37 x 18 x 8 6mm 5g Charger 81 5 x 68 5 x 77mm 177g 11 2 Power Requirements 11 3 Operating and Storage Conditions If the system is stored at a temperature outside th...

Страница 33: ...ser of the Earlens Hearing Aid should ensure that it is used in such an environment not to exceed conditions listed below Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Earlens Hearing Aid does not use RF energy for any of its functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipme...

Страница 34: ...in the electromagnetic environment specified below The customer or user of the Earlens Hearing Aid should ensure that it is used in such an environment not to exceed conditions listed below Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz V1 3Vrms 6Vrms in I...

Страница 35: ...Level 10 V m 0 01 0 12 0 2 0 12 0 23 0 1 0 38 0 63 0 38 0 73 1 1 2 2 0 1 2 2 3 10 3 7 6 3 3 8 7 3 100 12 20 12 23 11 5 FCC Compliance FCC ID 2AGDU EL1 IC ID 20825 EL1 The Earlens Light Driven Hearing Aid complies with part 18 of the FCC rules and ICES 003 of the IC rules 12 Glossary of Terms 13 Graphic Symbols Contained in Device Labeling Symbol Description Reference Symbol Description Reference R...

Страница 36: ... manufacture ISO 15223 1 2012 5 1 3 Type BF applied part IEC 60601 1 2005 IEC 60417 5333 Non ionizing radiation IEC 60601 1 2 2007 IEC 60417 5140 2003 04 14 Laser Certification The Earlens Light Driven Hearing Aid complies with 21CFR 1040 10 and 1040 11 Manufactured by Ref ISO 15223 1 2012 5 1 1 Earlens Corporation 4045A Campbell Ave Menlo Park CA 94025 European Authorized Representative Ref ISO 1...

Страница 37: ...ad Air iPad 4th generation iPad mini 4 iPad mini 3 iPad mini with Retina display iPad mini iPod touch 5th generation using iOS 9 or later Apple the logo AirPlay iPhone iPad iPod are trademarks of Apple Inc registered in the U S and other countries ...

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