Not for print. Microphone Test Device with SONNET MTD Adapter. User Manual. Cochlear Implants NOT FOR PRINT

Transcription

1 Cochlear Implants Microphone Test Device with SONNET MTD Adapter User Manual AW32690_1.0 (English)

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3 Table of contents 1. Table of contents 2. INTRODUCTION 3 Product description 3 3. INTENDED USE INDICATIONS CONTRA-INDICATIONS 4 Intended use 4 Indications 4 Contra-indications 4 4. MICROPHONE TEST DEVICE 5 System components 5 Microphone Tester controls 7 How to perform a microphone test 9 5. EVALUATION AND TROUBLESHOOTING GENERAL PRECAUTIONS AND WARNINGS 13 General precautions for your Microphone Test Device (MTD) CARE AND MAINTENANCE 14 Disposal 14 Batteries TECHNICAL DATA 17 Symbols 18 Guidance and manufacturer s declaration APPENDICES 23 Warranty and guarantee 23 Manufacturer address CONTACT MED EL 24 1

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5 Introduction 2. Introduction This user manual provides information and instructions regarding the Microphone Test Device with SONNET MTD adapter (hereafter referred to as MTD). It includes descriptions of available parts and configurations as well as instructions for troubleshooting and proper care of the system and its components. The MTD is an optional service tool that can be connected to the SONNET audio processor. Please also refer to the audio processor user manual, which you should have received with your SONNET audio processor. Please contact your CI centre or MED EL with any additional questions you may have. This symbol indicates information that is particularly relevant for parents of implanted children. PRODUCT DESCRIPTION The MTD is an optional service tool for the MED EL Cochlear Implant System to subjectively evaluate the microphones contained in the SONNET audio processor. The MTD is not necessary for the function of the audio processor. Individuals with normal hearing can hear the amplified microphone signal via headphones to detect a malfunctioning microphone. The MTD is only used to subjectively evaluate the SONNET microphones. The MTD uses one primary or one rechargeable 1.2 to 1.5 Volt size AA battery. 3

6 Intended use Indications Contra-indications 3. Intended use Indications Contra-indications INTENDED USE The Microphone Test Device in combination with the SONNET MTD adapter is intended as a service tool to subjectively evaluate the microphones contained in the SONNET audio processor. It is intended for indoor use only. INDICATIONS Persons with normal hearing are indicated to use the Microphone Test Device with SONNET MTD adapter in conjunction with the SONNET audio processor. CONTRA-INDICATIONS Individuals known to be intolerant of the materials used in the audio processors or the MTD and headphones should not use the MTD. For further details please refer to chapter Technical data in the audio processor user manual and in this user manual. For more information on intended use, indications and contra-indications of your audio processor, please refer to the applicable audio processor user manual. 4

7 Microphone Test Device 4. Microphone Test Device SYSTEM COMPONENTS The MTD consists of the following components: Fig. 1 Microphone Tester (MTS) Fig. 2 SONNET MTD adapter The SONNET MTD adapter enables wireless transmission of the SONNET microphone signals via the attached audio processor coil (D Coil and DL-Coil). 5

8 Microphone Test Device Fig. 3 Headphones (example) Use standard headphones with an impedance of 8 to 32 Ohm at 1 khz. The headphones must have a 3.5 mm stereo jack connector or an adapter allowing connection to the 3.5 mm socket of the Microphone Tester. Fig. 4 FineTuner Make sure to use a FineTuner with revision x.1 (e.g. 7.1, 8.1). The MTD is delivered with the correct revision of the FineTuner. 6

9 Microphone Test Device MICROPHONE TESTER CONTROLS Headphone socket (3.5 mm) Red and green LEDs Self-test button Socket for connection cable Volume control ON/OFF switch Battery compartment Battery compartment lock Fig. 5 Microphone Tester controls 7

10 Microphone Test Device ON/OFF switch You may select the following positions: ON: push to the left side OFF: push to the right side In switch position OFF, the Microphone Tester is turned off. No current is drawn in this position. Make sure to turn your Microphone Tester to the OFF position when not in use, as this prolongs the lifetime of the battery. In switch position ON, the Microphone Tester is turned on. Volume control Turn the volume control to the right or left to adjust the loudness of the headphone signal. The volume control is located at the bottom of the device. Self-test button Before evaluating the microphone, check for properly functioning headphones and amplifier circuit by pressing the self-test button. When the system functions properly, you will hear an acoustic signal. Light emitting diodes (LED) The light emitting diodes (LED) indicate the status of the battery. The red LED signals low battery and you should change or, if applicable, recharge the battery when the red LED illuminates. The green LED indicates operation, i.e. battery voltage is higher than approximately 1.15 Volt. Battery compartment lock The battery compartment lock is located at the right side of the device (see Fig. 4). Push it down to unlock the battery compartment. 8

11 Microphone Test Device HOW TO PERFORM A MICROPHONE TEST IMPORTANT Testing the microphone signal via headphones is a subjective evaluation. 1. Connect the SONNET MTD adapter to the Microphone Tester (MTS). 2. Connect the headphones to the Microphone Tester. 3. Turn the volume control of the Microphone Tester to the minimum position. 4. Remove the SONNET audio processor from the patient s head. 5. To activate the monitoring mode of the SONNET audio processor, press the M key of the FineTuner for more than 2 seconds. This mode transmits the microphone signal via the coil and the SONNET MTD adapter to the Microphone Tester (MTS). IMPORTANT Activating the monitoring or listening mode requires a revision x.1 (e.g. 7.1, 8.1) FineTuner. The SONNET audio processor is delivered with the correct revision of the FineTuner. When using a FineTuner provided earlier, you have to check for the correct revision. The revision is printed in the battery compartment of your FineTuner. You need to remove the battery to see the revision number. Removing/inserting the battery is described in your SONNET audio processor user manual. It is not possible to activate the monitoring or listening mode for your SONNET audio processor with a FineTuner with revision x.0 (e.g. 7.0, 8.0). The link check function of the DL-Coil is not available in the microphone test mode. 6. Make sure that the headphones are not in the vicinity of the microphone to avoid feedback. 7. Turn on the Microphone Tester. 8. Place the coil of the audio processor onto the flat side of the SONNET MTD adapter. 9. Put on the headphones to hear the signal. 10. Speak into the microphone or make a soft noise to test the microphone. Avoid loud noises near the MTD and ensure proper function of the headphones before performing this test (e.g. by connecting the headphones to other equipment). 9

12 Microphone Test Device NOTE: You can listen to different programmes. To switch between programmes press the appropriate key on your FineTuner as you would when changing programmes during normal operation. The FM signal may also be perceived with the FM cover and FM device attached. IMPORTANT A soft, high-frequency buzzing may be audible when the coil of the SONNET audio processor is connected to the control unit. This is normal and does not indicate any defect, the buzzing sound is not audible for the user of the audio processor. 11. After completing the microphone evaluation, exit the monitoring or listening mode by pressing the M key on the FineTuner for more than 2 seconds or by switching your SONNET audio processor off and back on. IMPORTANT While the monitoring or listening mode is active, transmission from the coil to the implant is interrupted. When accidentally pressing the M key on the FineTuner for more than 2 seconds while the user is wearing the audio processor with the coil over the implant, transmission to the implant will be interrupted and the user will not be able to hear. 10

13 Evaluation and troubleshooting 5. Evaluation and troubleshooting The microphone test is a subjective evaluation with generally two possible results: 1. A signal is perceived (not including hissing sounds). 2. No signal is perceived (i.e. silence or hissing sounds). In general, the microphone is working properly when sounds and signals can be heard via the headphones. Check coil cable and coil if no signal is perceived. IMPORTANT Small microphone sensitivity changes cannot be evaluated with this test. Only experienced users of the device are likely to notice a microphone sensitivity loss in a certain frequency range, but even so, evaluation is difficult and an objective test should be performed. If no signal but hissing sound is perceived, check that the SONNET MTD adapter and the headphones are correctly connected, including the cable of the headphones. Press the selftest button (see Fig. 6). When activated, this function generates an acoustic signal which is sent through the entire amplifier circuit. The signal is then received by the headphones as a test tone. Fig. 6 Activating the self-test 11

14 Evaluation and troubleshooting For troubleshooting the self-test function, please refer to Fig. 7. If you do not hear a signal from the microphones but hear the test tone, the microphones of the audio processor may be defective. Please contact MED EL. Switch ON the Microphone Tester Push self-test button Switch OFF the Microphone Tester Check headphones yes Microphone Tester is damaged Fig. 7 Troubleshooting Green light yes Headphones OK? Test tone audible? no Check control light of the Microphone Tester Check headphone cable alternative Green light? Red light? No light? Headphones connected correctly? no yes Red light or no light no Change headphones Use working headphones Exit Change battery Connect headphone cable correctly 12

15 General precautions and warnings 6. General precautions and warnings IMPORTANT For information on the safe use of the MED EL Cochlear Implant System please refer to your audio processor user manual or ask your CI centre or MED EL. GENERAL PRECAUTIONS FOR YOUR MICROPHONE TEST DEVICE (MTD) The MTD contains sophisticated electronic components. The electronics are designed to be durable but must be treated with care. Never open the housing of your Microphone Tester and SONNET MTD adapter. Unauthorised opening invalidates the warranty. To change the batteries or clean the battery contacts, open only the battery compartment lid as described in chapter 7, Care and maintenance. Your MTD and its components do not require regular maintenance by clinic personnel or other experts. The defined operating temperature range for the MTD is between +10 C and +45 C. Do not leave the MTD in direct sunlight (particularly inside a car). Avoid getting your MTD wet as this may impair its function. Keep the device away from moisture. The MTD is for indoor use only. The MTD contains sophisticated electronic components requiring special precautions regarding electromagnetic compatibility (EMC). When activating your MTD always follow the guidelines outlined in your audio processor user manual. Mobile phones and other portable and mobile RF communications equipment may interfere with your MTD. Do not use the MTD adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the MTD should be observed to verify normal operation in the configuration in which it is used. 13

16 Care and maintenance 7. Care and maintenance For maintenance of your audio processor please refer to the applicable audio processor user manual. Do not clean the MTD in or under water. Use a damp cloth to gently clean the components. Do not use aggressive cleaning agents. Prevent water from running into the MTD via the connectors or controls. Do not try to repair the electronic parts of the system, and do not try to open any component of the system as this voids the warranty. DISPOSAL This product must not be disposed of with your other household waste. Please dispose this product by returning it to your local MED EL subsidiary or distributor. Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserve natural resources. Moreover, proper recycling of the electronic and electrical waste equipment will ensure safety of human health and environment. 14

17 Care and maintenance BATTERIES The Microphone Tester requires one primary or rechargeable AA battery. Batteries of bad or low quality may adversely affect the durability of the device. Please note that rechargeable batteries reach their full capacity only after the first 3 4 charging/ discharging cycles. It is recommended to use the rechargeable batteries which are supplied with the complete system. Do not touch the battery contacts on the batteries and in the Microphone Tester. If the contacts need to be cleaned, use a cotton swab and a small amount of cleaning alcohol. Gently wipe dry after cleaning. If you do not use the Microphone Tester for an extended period of time, you should remove the batteries and dispose of or store them separately. Changing the battery When the red LED illuminates when turning on the Microphone Tester, or no LED illuminates, the battery must be replaced. 1. Before exchanging the battery, turn off the Microphone Tester. 2. Push the battery compartment lock at the right side of the device downwards (see Fig. 8-1). Push the battery compartment lid backwards until it snaps into place (Fig. 8-2). 3. Remove the empty battery. 4. Please make sure to clean and to keep dry both, the battery contacts of the device and the contacts of the battery. 5. Before inserting the new battery, check for correct polarity: Pick up the battery at the negative pole and place it into the Microphone Tester, the positive pole + facing the overmould battery contact as shown in Fig Close the battery pack by pushing the battery compartment lid forward until it snaps into place (Fig. 8-4). Do not use excessive force when opening or closing the battery compartment. IMPORTANT Always remove used batteries immediately to avoid leaking and possibly damaging your Microphone Tester. Used batteries should be disposed of according to local regulations. Generally, batteries are collected separately and not disposed of with the household garbage. 15

18 Care and maintenance To prevent children from swallowing or choking on batteries, always keep new and used batteries out of the reach of children. Children shall be instructed not to swallow or put any components of the MED EL Cochlear Implant System into their mouths and not to play with any components. See your audio processor user manual for further information Fig. 8 Changing the battery 16

19 Technical data 8. Technical data Dimensions of the Microphone Tester 1 Length: 72 mm Width: 43 mm Height: 19 mm Weight: 42 g (without battery) Dimensions of the SONNET MTD adapter 1 Length: 46 mm Length (with cable): 580 mm Width: 33 mm Height: 8 mm Weight: 8 g Power supply One primary or rechargeable size AA battery ( V) Stereo connector Standard 3.5 mm stereo jack Use commercial headphones with 8 to 32 Ω (typically Ω) at 1 khz Temperature range and humidity Temperature range in operation: 10 C to 45 C Temperature range for storage: 20 C to 60 C Relative humidity range: 0 % to 93 % under 31 C 0 % to 90 % from 31 C to 60 C For technical data of the audio processor please refer to the applicable audio processor user manual. 1 typical values 17

20 Technical data SYMBOLS The Microphone Test Device is in compliance with directive 2004/108/EC (Electromagnetic Compatibility / EMC) and directive 2011/65/EU (Restriction of Hazardous Substances / RoHS). CE mark applied in Fragile; handle with care Relative humidity Temperature limit 18

21 Technical data GUIDANCE AND MANUFACTURER S DECLARATION Tables according to IEC for Microphone Test Device Electromagnetic emissions for all equipment and systems The Microphone Test Device is intended for use in the electromagnetic environment specified below. The customer or the user of the Microphone Test Device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations / flicker emissions IEC Group 1 Class B Not applicable Not applicable The Microphone Test Device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Microphone Test Device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 19

22 Technical data Electromagnetic immunity for all equipment and systems The Microphone Test Device is intended for use in the electromagnetic environment specified below. The customer or the user of the Microphone Test Device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC Electrical fast transient / burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply lines IEC ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input / output lines ±1 kv line(s) to line(s) ±2 kv line(s) to earth <5 % U T (>95% dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles ±6 kv contact ±8 kv air Not applicable Not applicable Not applicable Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Microphone Test Device requires continued operation during power mains interruptions, it is recommended that the Microphone Test Device be powered from an uninterrupted power supply or a battery. <5 % U T (>95% dip in U T ) for 5 sec Power frequency 3 A/m 3 A/m Power frequency magnetic fields should (50/60 Hz) be at levels characteristic of a typical magnetic field location in a typical commercial or hospital IEC environment. NOTE U T is the a.c. mains voltage prior to application of the test level. 20

23 Technical data Electromagnetic immunity for equipment and systems that are not life-supporting The Microphone Test Device is intended for use in the electromagnetic environment specified below. The customer or the user of the Microphone Test Device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the Microphone Test Device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17 * P d = 1.17 * P 80 MHz to 800 MHz d = 2.33 * P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a: Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Microphone Test Device is used exceeds the applicable RF compliance level above, the Microphone Test Device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Microphone Test Device. b: Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 21

24 Technical data Recommended separation distances between portable and mobile RF communications equipment and the Microphone Test Device for equipment and systems that are not life-supporting The Microphone Test Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Microphone Test Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Microphone Test Device as recommended below according to the maximum output power of the communications equipment. Rated maximum output power of Separation distance according to frequency of transmitter m transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz W d = 1.17 * P d = 1.17 * P d = 2.33 * P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 22

25 Appendices 9. Appendices WARRANTY AND GUARANTEE Our warranty is in agreement with statutory warranty claims. In addition, MED EL grants a one-year guarantee for the Microphone Tester unless local laws provide for longer warranties. This warranty exclusively covers product failures; it shall not apply to any MED EL product subjected to physical or electrical abuse or misuse, or operated in any manner inconsistent with the applicable MED EL instructions. The period of warranty and guarantee begins on the day of delivery of the device. Repair of a device under guarantee does not renew or prolong the original guarantee period. MANUFACTURER ADDRESS MED EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) office@medel.com 23

26 Contact MED-EL 10. Contact MED EL Please refer to the accompanying Contact Sheet for your local office. 24

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28 MED-EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria medel.com 10% -20 C (-4 F) 93% +60 C (+140 F)