Use Instructions

ManualsBrandsEarlens ManualsElectronicsInductive Pen

IFU00042v03

1. Introduction ......................................................................................................... 2

2. Earlens Inductive Pen Description ..................................................................... 2

3. Intended Use ........................................................................................................ 2

4. Warnings .............................................................................................................. 2

5. Precautions .......................................................................................................... 3

6. Operating Instructions ........................................................................................ 3

7. Operating Specifications .................................................................................... 4

8. FCC Information .................................................................................................. 4

9. Electromagnetic Compatibility Compliance Statement .................................. 5

10. Summary of Wireless Technology ..................................................................... 9

11. Graphic Symbols Contained in Device Labeling .............................................. 9

Earlens® Inductive Pen Instructions For Use

Summary of content (10 pages)

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Earlens® Inductive Pen Instructions For Use 1. Introduction ......................................................................................................... 2 2. Earlens Inductive Pen Description..................................................................... 2 3. Intended Use ........................................................................................................ 2 4. Warnings .............................................................................................
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1. Introduction Carefully read all instructions prior to use. 2. Earlens Inductive Pen Description The Earlens Inductive Pen (Figure 1) is a portable, battery operated tool that features a lowinductive source. When placed in the ear canal, the Inductive Pen projects an Inductive signal into the ear canal. Figure 1. Inductive Pen components 3.
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5. Precautions Before using the Earlens Inductive Pen, read and make sure you understand each of the following safety precautions. • • • • • Avoid getting the Inductive Pen wet, as this may damage the device. Only individuals trained in the evaluation and placement of hearing aids should use the Inductive Pen. Handle the Inductive Pen carefully. Do not drop it and prevent hard knocks. This may damage the device.
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a. Open the battery compartment by twisting the battery cap counter-clockwise until the cap comes off. b. Replace with a disposable or rechargeable AAA battery with the positive end of the battery facing towards the Transmit Coil. c. Close the battery compartment by placing the battery cap on the Inductive Pen and twisting the battery cap until fully secured. d. The Power Indicator Display will flash blue twice indicating proper insertion. 7.
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9. Electromagnetic Compatibility Compliance Electromagnetic Compatibility Compliance Statement • Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents. • Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
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Portable and mobile RF communications should be used no closer to any part of the Earlens® Inductive Pen, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P 3 V/m 80 MHz to 2.7 GHz d = 1.2√P 80 MHz to 800 MHz Radiated RF IEC 61000-4-3 d = 2.3√P 800 MHz to 2.
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(W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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5785 a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
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10. Summary of Wireless Technologies The Earlens® Inductive Pen incorporates only one wireless technology. This is the inductive link to transmit data and power from the Inductive Pen to the Tympanic Lens. Description of Inductive Link: A proprietary inductive link which operates at a nominal range of 5 mm, transfers both the audio signal and power to the motor in the Lens via a coupled magnetic field. The Inductive Pen generates an amplitude modulated (AM) transmit signal, over a carrier frequency of 2.
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Manufactured by (Ref. ISO 15223-1:2016, 5.1.1): Earlens Corporation. 4045A Campbell Ave. Menlo Park, CA 94025 European Authorized Representative (Ref. ISO 15223-1:2016, 5.1.2): Medimark® Europe SARL 11, Rue Emile Zola, B.P.