Earlens INDPEN User Manual

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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
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IFU00042v03
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. Intended Use
The Inductive Pen is an optional tool available for the convenience of the health care professional to demonstrate the Earlens Contact Hearing Solution sound quality experience after proper placement. The Inductive Pen does not affect the normal operation of the Earlens Contact Hearing Solution to amplify sound in the ear. The Inductive Pen is not intended to support, supplement, or augment the performance of the Earlens Contact Hearing Solution to amplify sound in the ear.
4. Warnings
Before using the Earlens Inductive Pen, read and make sure you understand each of the following safety warnings.
Should the device become damaged, stop use and contact Earlens Customer Care.
Do not crush, short circuit, modify or disassemble any component of the Inductive Pen.
Do not incinerate any component of the Inductive Pen or use near open flame.
Handle waste from electronic equipment per local regulations.
When using any instruments in the ear canal, be careful to avoid damaging the
ear canal or tympanic membrane.
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IFU00042v03
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.
If the Inductive Pen fails to operate or if it appears damaged, including battery leakage, or swelling of the device, stop use and contact Earlens Customer Care.
DO NOT AUTOCLAVE.
6. Operating Instructions
First Time Inductive Pen Use
When you receive the Inductive Pen, you must first insert the supplied AAA battery.
a. Open the battery compartment by twisting the battery cap counter-clockwise
until the cap comes off.
b. Place the AAA battery with the positive end of the battery facing towards the
transmit coil tip.
c. Close the battery compartment by place the battery cap on the Inductive
Pen and twisting until fully secured.
d. The LED will blink twice, indicating the battery was inserted correctly.
Earlens Inductive Pen Demonstration Instructions
a. Prior to use, wipe the Transmit Coil with an isopropyl alcohol-soaked wipe
or cloth.
b. Turn on the Inductive Pen by pressing the button. When the device is
ON, the power indicator will display a blue light.
c. Place the Inductive Pen carefully in the ear canal aiming it at the Lens and
gradually advance it forward until the patient can hear the music. Ensure the Inductive Pen does not contact the Lens.
d. Hold the Inductive Pen in position for 30 seconds to demonstrate the
sound experience for the patient. e. Gently remove the Inductive Pen from the ear canal. f. Turn OFF the Inductive Pen by pressing the On/Off button again. g. Wipe the Transmit Coil with an isopropyl alcohol-soaked wipe or cloth.
Note – If the Inductive Pen is not turned off following use, it will automatically turn off after 5 minutes.
Battery Replacement
If the battery is low, the Power Indicator Display will turn from blue to red when the Inductive Pen is ON.
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