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USER INSTRUCTIONS

M-DEX

PACKAGE CONTENTS

M-DEX

User instructions

Lanyard

Charger

Jack-to-jack cable

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CONTENTS

SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5YOUR NEW M-DEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6DESCRIPTION OF DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

M-DEX OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7STATUS ICONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

BATTERY STATUS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8BLUETOOTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8ROOM OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

OPERATING RANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9LANYARD USAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

CHARGING THE BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12TURNING ON THE M-DEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14TURNING OFF THE M-DEX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

STANDBY SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16MANUAL KEYLOCK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

BASIC FUNCTIONS – REMOTE CONTROL . . . . . . . . . . . . . . . . . 18CHANGING PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18ADJUSTING THE VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20CHOOSING LISTENING FOCUS . . . . . . . . . . . . . . . . . . . . . . . . . 21ROOM OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

BASIC FUNCTIONS – MOBILE PHONE . . . . . . . . . . . . . . . . . . . . 25PAIRING THE M-DEX WITH YOUR MOBILE PHONE . . . . . . . 25MOBILE PHONE CONVERSATIONS VIA THE M-DEX . . . . . . 29ACCEPT OR REJECT CALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30END CALL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31MAKING A CALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31USING THE CALL LOG TO MAKE A CALL . . . . . . . . . . . . . . . . 31TRANSFER CALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32HANDS-FREE OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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OTHER FUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34ADJUSTING THE VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34ROOM OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

ADVANCED FUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35BLUETOOTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36AUDIO INPUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39L/R VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42M-DEX T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44SETTINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

IN CASE OF MALFUNCTION.... . . . . . . . . . . . . . . . . . . . . . . . . . . 53CARING FOR YOUR M-DEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55WARNINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56SAFETY WARNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57REGULATORY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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SYMBOLS

The following symbols will be used throughout the manual:

WARNINGMessages with this heading indicate adverse reactions, potential safety hazards or inadequate device perform-ance.

CAUTIONMessages with this heading indicate/include informa-tion regarding any special care to be exercised.

Non-ionizing radiation.

Not for general waste.

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YOUR NEW M-DEX

Your M-DEX is part of the DEX™ family of assistive lis-tening devices. These user instructions explain how the M-DEX should be operated.

WARNINGThis booklet contains important information and instructions. Please read this booklet care fully before you start using the de-vice.

INTENDED USEThe M-DEX is a wireless device intended for mobile phone applications, as well as an advanced remote con-trol.

DESCRIPTION OF DEVICEM-DEX is an advanced hearing aid remote control. M-DEX reproduces mobile phone conversations direct-ly in the hearing aid and allows the user to control nor-mal mobile phone functions and listen to audio input, using a Bluetooth connection for compatibility with most models of mobile phone, and WidexLink for con-nection to Widex hearing aids.

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M-DEX OVERVIEW

�1. On/off�2. Yes (green)�3. No (red)�4. Volume up�5. Volume down�6. Previous�7. Next �8. Menu�9. Room Off10. FreeFocus11. Microphone

910

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5

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STATUS ICONS

When the M-DEX is turned on, you can see the battery, Bluetooth and Room Off status in the upper right cor-ner of the start screen.

BATTERY STATUSFull Low

BLUETOOTH (blue=connected, grey=on (but not connected), icon not visible=off)

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ROOM OFF (Icon shown only if feature is active).

OPERATING RANGES

From the M-DEX to the hearing aids

When using it as a remote control up to 1 meter/3 feet

With mobile phones, Bluetooth and transmitted audio input, incl. M-DEX T

up to 50 cm/1½ feet

From the M-DEX to mobile phone

up to 10 meters/30 feet

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LANYARD USAGE

If you wish to wear the M-DEX around your neck, place it in the plastic holder at the end of the lanyard provided, as illustrated.

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1.

WARNINGThe breakaway buckle of the lanyard must be positioned at the back of your neck (1), to make it easier to unsnap.

CAUTION: FOR PACEMAKER USERS

(Risks) The use of the CLEAR/DEX should not interfere with other devices such as a pacemaker. However, to be extra cautious, Widex follows the guidelines recommended by the manufacturers of implantable defibrillators and pacemakers for their patients when using mobile phones. Specifically, hearing aid wearers who also use a pacemaker should

• Keep the hearing aids at a distance of at least 15 cm/½ foot away from the pacemaker and

• Do not carry the hearing aids (and/or any of the DEX accesso-ries) in a shirt pocket or close to the chest.

• If any interference is observed, do not use the hearing aids (and/or DEX) and contact your pacemaker manufacturer and hearing healthcare professional immediately.

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GETTING STARTED

CHARGING THE BATTERYThe M-DEX uses a rechargeable battery. When fully charged, the battery has a capacity of approx. 5 hours of continuous use (when on standby, the battery will last approximately three days. If Bluetooth is turned on, this period will be considerably reduced). The charger is available in four country versions. The version you have may therefore not look exactly as illustrated in this booklet.

To charge the battery1. Connect the charger to the M-DEX.2. Plug the charger into a wall socket.

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It takes approximately 6 hours to charge the battery the first time. Allow the battery to charge for the full six hours, even if the “battery full” icon appears.

Recharging takes approx. 3 hours, depending on whether the device is turned on or off.

WARNINGDo not attempt to change the battery yourself. Contact your hearing care professional if the battery needs replacement.

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TURNING ON THE M-DEX

Push the slide button on the right side upwards.

NoteThe icons and screens in your M-DEX will depend on how it has been configured by the hearing care professional in coopera-tion with you. Your dispenser will have matched the M-DEX with your hearing aids. Once this is done, you will be able to change programs and adjust the volume in your hearing aids.

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The program in position number 1 (usually Master) is displayed.

TURNING OFF THE M-DEX

To turn the M-DEX offPush the slide button on the right side of the M-DEX downward.

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STANDBY SCREENTo save power, the M-DEX screen will automatically enter standby mode when it has not been used for 10 seconds.

To leave standby mode Use any key except the on/off button. If the other keys are locked, you can use the “No” key to leave standby mode.

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MANUAL KEYLOCKYou can activate the keylock from any program screen.

To activate the keylockPress No ➞ Menu

To deactivate the keylockPress No ➞ Menu

For information on automatic keylock, see page 49.

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BASIC FUNCTIONS – REMOTE CONTROL

From the start screen you can change programs in your hearing aid, adjust the volume, choose listening focus and activate/deactivate Room Off.

Except when using the Room Off function, your hearing aids will produce speech messages or tones when you change settings, unless the function has been deacti-vated by your hearing care professional.

If a check mark is displayed, it means that the specific function has been activated.

CHANGING PROGRAMThe selection of listening programs in your M-DEX de-pends on how many and which programs you have cho-sen to have in your hearing aid. The order of the pro-grams is the same as in your hearing aid.

The M-DEX always starts up in the program which has been chosen as program number 1 by you and your hearing care professional (usually the Master program).

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To navigate through the available programsPress or

Every time you press one of the arrows, an icon repre-senting the active program is displayed.

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ADJUSTING THE VOLUMETo access the volume barsPress or

To increase or decrease the volume in both hearing aidsPress or

The volume adjustment will apply only to the listening program that is currently active.

The wider bar in the middle indicates the default set-ting. The icon displayed reflects the number of volume adjustment steps chosen by your hearing care profes-sional in consultation with you.

The binaural volume adjustment closes automatically after a few seconds. To close it manually, press the No key.

Changing to another program or turning the M-DEX off will cancel any volume adjustment.

If you adjust the volume on the hearing aid’s volume control, this adjustment will not be copied into the M-DEX.

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To adjust the volume of your two hearing aids separate-ly, see “Advanced functions”.

CHOOSING LISTENING FOCUSThe FreeFocus feature allows you to focus on sound from a specific direction with your hearing aids.

Press the FreeFocus key

The FreeFocus key lights up to indicate that FreeFocus is activated.

To focus on sound from the frontPress ➞ Menu

To focus on sound from behindPress ➞ Menu

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To focus on sound from the rightPress ➞ Menu

To focus on sound from the leftPress ➞ Menu

When you choose a setting and lock it by pressing Menu, a check mark confirms your choice. You can “un-lock” your choice by pressing Menu again.

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To adjust the volume in FreeFocusFirst, choose the direction of focus and lock the setting. Then use the same procedure as for the hearing aids’ listening programs.

To deactivate FreeFocus Press the FreeFocus key

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ROOM OFFActivating ‘Room Off’ turns the hearing aid micro-phones off. This allows you to use the feature to listen directly to transmitted audio sound without interfer-ence from surrounding sounds, or as a mute function with your normal listening programs (e.g. Master).

To activate Room OffPress the Room Off key.

The Room Off key lights up and the Room Off icon is displayed.

To deactivate Room OffPress the Room Off key again

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BASIC FUNCTIONS – MOBILE PHONE

PAIRING THE M-DEX WITH YOUR MOBILE PHONEWhen you use the M-DEX with your mobile phone for the first time, you will need to pair the two devices.

1. Turn on Bluetooth on your mobile phone.2. Turn on Bluetooth on your M-DEX. To to this: 2a. Press the Menu key from any program screen.

This screen is displayed.

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2b. Press or until you reach Settings.

Press Menu ➞ Menu.

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If Bluetooth is not already turned on, this screen will be displayed.

2c. Press the Menu key to turn on BT. This screen is displayed.

3. On your mobile phone, search for new devices. Refer to the user instructions for your phone to see how to do this.

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4. When the M-DEX is found on the mobile phone, pair the two devices. To do this:

4a. Press or to go to pairing

4b. Press the Menu key 4c. Press the Menu key again to start pairing. You

can follow the progress on the screen.

5. Select the M-DEX on your phone, and enter the pin code (0000) displayed on your M-DEX into your phone, if prompted.

The devices are now paired.

If no device can be detected, “Device not found. Try again?” will be displayed on your M-DEX.

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NOTEThe next time you want to use M-DEX with your mobile phone, make sure that Bluetooth is turned on in both units. Please note that using the devices with Bluetooth turned on will significant-ly increase their battery consumption.

MOBILE PHONE CONVERSATIONS VIA THE M-DEXHold the M-DEX as you would hold a phone and speak into the microphone. The sound will be heard in both hearing aids. The mobile phone must be within range (up to 10 m/30 feet).

Mobile phone

M-DEX

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When connected to your mobile phone, the M-DEX gives access to the following functions:

1. Accept or reject call2. End call3. Transfer call4. Make a call5. Hands-free operation

ACCEPT OR REJECT CALLWhen you receive a call, you will hear your mobile phone ringing, and if the M-DEX is within range of your hearing aids, you will also hear a tone in these. You can choose to accept or reject the call by selecting “Yes” or “No”.

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END CALLTo end a callPress End

MAKING A CALLTo make an outgoing callDial the telephone number on your mobile phone and use the M-DEX as described on page 29.

USING THE CALL LOG TO MAKE A CALLTo make a call to one of the last five numbers registered in the Call log:

Press the Yes keyUse the or key to choose the desired number.Press the Yes key.

Arrows indicate whether it is an incoming or outgoing call.

To leave Call log: Press the No key.

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TRANSFER CALLThe transfer function allows you to transfer the call back to the mobile phone.

To transfer a call to the mobile

Press Transfer ➞ Yes

A check mark confirms your choice.

Turning off your M-DEX will also transfer the call back to the mobile phone.

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HANDS-FREE OPERATIONFor hands-free opera-tion, wear the M-DEX around your neck and speak into its micro-phone.






Max 30 cm Max 30 cm/1 foot

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OTHER FUNCTIONS

ADJUSTING THE VOLUMEYou can adjust the volume during a telephone conver-sation.

To access the volume barsPress or

To increase or decrease the volumePress or

ROOM OFFYou can also use the Room Off function during phone conversations. See page 24.

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ADVANCED FUNCTIONS

The following advanced functions can be accessed by pressing the Menu key once and using or :

If you use , the menu items are placed in the following order

1. Bluetooth *2. Audio Input *3. L/R volume4. M-DEX T *5. Settings

Choices made in options 1, 2 and 5 will be confirmed by a check mark.

Because items 1, 2 and 4 involve transmitted sound, the sound in your hearing aids will be affected every time you confirm a choice in these options. When you leave these functions, you will return to program 1.

* The M-DEX must be within a range of 50 cm/1½ feet of the hearing aids.

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BLUETOOTH The Bluetooth menu is only available (indicated by a blue colour) if Bluetooth is activated in your M-DEX and this is connected to a Bluetooth unit. Otherwise it will be greyed out.

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NoteWhen using the M-DEX for Bluetooth transmission, it must be within range of the hearing aids (up to 50 cm/1½ feet).






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To start transmission:Press the Menu key. On some personal audio devices, e.g. telephones, the music player may need to be acti-vated before it can play music. In the default Bluetooth setting, the hearing aid emphasizes Music. To optimize it for Speech instead, use or .

To confirm a new settingPress Menu key

To leave BluetoothPress No ➞ No

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AUDIO INPUTThis function may be useful if you wish to listen to an external audio source such as an mp3 player. When you connect a jack plug to the audio input, the Audio input screen will automatically be displayed.

The Audio input menu is only available (indicated by a blue colour) if the M-DEX and the audio source are con-nected by a jack-to-jack cable.

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NoteWhen using the M-DEX for audio input, it must be within range of the hearing aids (up to 50 cm/1½ feet).






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To start transmission:Press Menu. In the default Audio input setting, the hear-ing aid is optimized for Music. To optimize it for Speech instead, use or .

To confirm a new settingPress the Menu key

To leave Audio InputPress No ➞ No

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L/R VOLUMEThis function is used if you wish to adjust the volume of your two hearing aids separately.

Press the Menu key

To select which hearing aid to adjust the volume for

Use or to choose left or right, respectively.

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To adjust the volume up and downUse or

To leave L/R volumePress No ➞ No

When you leave this pop-up screen, the volume in the hearing aids will be set to default level.

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M-DEX TThis option allows you to take advantage of teleloop systems even if you do not have a telecoil in your hear-ing aid. If your hearing aid is provided with a telecoil program, we recommend using this, for optimum per-formance.

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Using the telecoil in the M-DEXTo enable the M-DEX to pick up teleloop signals, it should hang in a vertical position and be within range of the hearing aids. (Up to 50 cm/1½ feet).






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To change the volume from the M-DEX T screenPress Menu and or

To leave M-DEX TPress No ➞ No

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SETTINGS

Pressing the Menu key gives you access to the following menu items:

1. Bluetooth Settings2. Automatic Keylock3. Vibrating Alert4. Reset Bluetooth5. Short-term Log6. Reset

To select a menu itemPress or to go to the desired item.

Press the Menu key to se-lect an item

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Bluetooth settingsHere you can turn Bluetooth on and off using the Menu key.

You can also perform Bluetooth pairing.

Bluetooth pairingSee page 25.

To go back to the menuPress No.

NotePlease note that using the M-DEX and mobile phone with Blue-tooth turned on will significantly increase their battery con-sumption.

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Automatic keylockThis function helps you avoid pressing a key acciden-tally, for example if you have your M-DEX in your pock-et.

If this function has been enabled, the M-DEX keys will automatically lock when the screen enters standby mode.

Use the Menu key to turn the automatic keylock on and off

To go back to the MenuPress No

To unlock the automatic keylockPress No ➞ Menu

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Vibrating alertIf you have chosen a Silent profile in your mobile phone, the vibrating alert will alert you when you receive a call.

To turn the vibrating alert on or off Press the Menu key


Reset Bluetooth This function allows you to delete previous Bluetooth pairings. This can be necessary if you change your mo-bile phone.

To select Reset BluetoothPress Menu


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Short-term LogIf you experience difficulties in a specific listening situ-ation, this feature allows you to make a one-minute re-cording of the situation. This can help your hearing care professional to fine-tune your hearing aids.

To start recordingPress the Menu key

The recording process takes one minute and cannot be interrupted. You can follow the progress on the screen.

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Please note that if you start a new log, the previous log will be deleted.


RESETThis function resets settings to: default volume, auto-matic keylock off, vibrating alarm off.

To reset the settings and volume to defaultPress Menu

To reset Bluetooth settings see page 50.

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IN CASE OF MALFUNCTION....

Problem Possible cause SolutionYour M-DEX does not work

The battery is ex-hausted

Charge the battery(see page 12)

Display shows “Please match with hearing aids”

The M-DEX is not matched with your hearing aids

Contact your hearing care professional

No Bluetooth streaming of tele-phone music when activating Bluetooth on M-DEX

On some personal audio devices, the music player may need to be activated before it can play music

Refer to the user man-ual for the telephone for further information

M-DEX not vibrat-ing when tele-phone rings

Vibrator not activat-ed in M-DEX

The vibrator function is activated under Set-tings

BT icon in M-DEX is blue but there is no connection to telephone

M-DEX has been paired with a differ-ent device, and has established contact with it

Turn BT off on the ac-tive equipment or re-set Bluetooth settings and pair telephone again

Your M-DEX is on but the display is black

Keylock is activated Press No > Menu

Sound from Blue-tooth/jack too low and/or noisy

Sound not turned up loud enough

Turn up the volume of the device connected to the M-DEX and turn down to a suitable volume on the M-DEX

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Problem Possible cause SolutionM-DEX takes a long time to charge or does not charge at all

Charger used is not the correct one

Use the charger in-cluded with your M-DEX

Program shown in M-DEX not the same as in the hearing aid

M-DEX and hearing aid not matched cor-rectly

Ask your hearing care professional to match again

Incoming call screen is shown but no telephone ringing tone is heard in the hear-ing aids

Some telephones do not produce a ring-ing tone in the hear-ing aids if telephone is set to silent

Turn off the silent function on your mo-bile phone

The M-DEX is not within range

Move it within range (up to 50 cm/1½ feet)

When a telephone key is pressed, the hearing aids beep and change to an-other program

Some telephones send keypad tone to the M-DEX

Turn off keypad tone on the telephone

Bluetooth pairing is not working

Reset Bluetooth under Settings and pair again

No sound when listening to audio

M-DEX is not within range of the hearing aids

Slide the M-DEX up-wards on the lanyard

Temporary sus-pension of com-munication be-tween hearing aids. Message: “Partner check”

Interference from devices emitting a strong electromag-netic field.

Keep at least 15 cm/½ foot away from potential sources of interference.

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CARING FOR YOUR M-DEX

The device is a valuable object and should be treated with care. Here are some things you can do to prolong the life of your M-DEX:

WARNING• Do not expose the device to extreme temperatures or high

humidity.• Do not immerse in water or other liquids.• Do not carry your M-DEX with you during X-rays, MRIs or

other scans or radiation treatments and never place it in a microwave oven. These are some of the types of radiation that can damage the device.

CAUTION• Never try to open or repair the device yourself. (This should

only be done by authorized personnel.)• Clean the device with a soft cloth. Never wash it with water,

cleaning solutions or other liquids.• Avoid dropping the M-DEX.• When the device is not in use, keep it in its case in a cool, dry

location out of reach of children and pets.

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WARNINGS

WARNING• Keep the M-DEX and its parts and accessories out of reach of

children and anyone else who might swallow parts of the de-vice, or otherwise cause injury to themselves with these items. In case of ingestion, contact a physician immediately.

• Do not use the device on aircraft or in hospitals without per-mission.

• Do not use the device in mines or other areas with explosive gases.

• If you wear your M-DEX around your neck, make sure that the breakaway buckle on the lanyard is always at the back of your neck.

CAUTION• Although the device has been designed to comply with the

most stringent international electromagnetic compatibility standards, the possibility cannot be excluded that it may cause interference with other equipment, such as medical de-vices.

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SAFETY WARNING

This device is powered by an external power supply.

• Only connect a power supply that is compatible with the M-DEX.

• The power supply must have an output rating of 5VDC, 500mA, and a mini USB connector.

• The power supply input rating voltage and wall plug must be compatible with the AC wall outlet in your region.

• The power supply must have the certification marks showing certification by a safety agency acceptable in your region.

Widex strongly recommends that you always use a power supply unit that is supplied by your Widex Dis-tributor to ensure safe and efficient use of your M-DEX.

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REGULATORY INFORMATION

The following Table summarizes the technical details of the WidexLink technology as it is implemented in the CLEAR hearing aids.

Unit M-DEX Hearing aid C4-PA

Type W-link Bluetooth* W-link

Antenna type

Inductive antenna

Embedded ce-ramic antenna

Inductive antenna

Antenna dimensions

Ø6 mmL – 40mm

NA Ø1.8 mmL – 4.85mm

Modulation FSK FHSS/GFSK, π/4 DPSK, 8DPSK

FSK

Magnetic Field Strength

-11dBμA/m at 10m distance

NA -54dBμA/m at 10m distance

Output power

8nW EIRP** +4dBm 29pW EIRP**

Range <1m remote unit to hearing aid.

<10m between M-DEX and Bluetooth device

<1m remote unit to hearing aid. <30cm be-tween hearing aids

Center frequency

10.6MHz 2.45GHz ISM 10.6MHz

Channels Single channel radio

5 logical channels

Single channel radio

Bandwidth 660kHz (-15dB) 1MHz 660kHz (-15dB)

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Data rate 212kbit/s raw channel capacity

2.1Mbit/s 212kbit/s raw channel capacity

Data flow Simplex or semiduplex

Time division duplex (TDD)

Simplex or semiduplex

Protocol Random access – no collision avoidance.

Packet based protocol, time divided; secure serial port pro-file (SPP)

Random access – no collision avoidance.

* Bluetooth specification v2.0 + EDR published by the Bluetooth Special Interest Group (SIG).

** EIRP = Equivalent isotropically radiated power.

Bluetooth Qualified design ID (QD ID): B017413

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(Benefits) The use of wireless transmission allows convenient and synchronized control of hearing aid functions. The CLEAR wireless hearing aids share input information between the two partner hear-ing aids. In so doing, the wearers would experience the following additional user benefits (only when wearing binaural CLEAR hearing aids).

Synchronization of volume control settings between hearing aids – The volume in both hearing aids will change when the VC is adjusted on one ear.

Synchronization of listening programs between hearing aids – The same listening program is used in both hearing aids when one is changed by the user.

Surveillance of partner hearing aid – The hearing aid(s) will signal an alert (“partner check”) when a hearing aid battery has expired, or that one of the hearing aids has fallen off. In rare instances, a much stronger wireless source nearby may activate this alert. This serves as an early warning to the wearer of such service interruption.

Coordination of compression – The CLEAR hearing aids maintain the intensity level difference between ears (inter-aural level difference, ILD). In some situations where speech is presented to one side and noise the other side, this coordinated action could enhance the rela-tive loudness of the speech sounds to the noise background and im-prove speech understanding for some wearers.

More accurate identification of feedback – The CLEAR hearing aids distinguish between “true” hearing aid whistling (or feedback) and music sounds to prevent unnecessary feedback cancellation and preserve natural sound quality.

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(Contraindications):• Congenital or traumatic deformity of the ear• Active drainage from the ear within 90 days• History of rapid progressive hearing loss within previous 90

days• Acute or chronic dizziness• Sudden unilateral hearing loss in previous 90 days

WARNING

(Warnings) In rare situations, the performance of the CLEAR hearing aids and/or the M-DEX may be affected by other de-vices emitting a much stronger EM field. For example, radia-tion from room surveillance equipment, burglar alarms and mobile phones may cause interference. Some mobile phone displays and computer monitors could interfere with the wire-less functions when the hearing aids are within a few cm from them. While the hearing aids are still functional, the communi-cations between the hearing aids may be temporarily sus-pended until the wearers remove themselves from the vicinity of the stronger EM field. A message “partner check” may be audible. Keep at least a distance of 15 cm/½ foot from these potential interfering sources.

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The M-DEX contains radio transmitters / receivers with the following

M-DEX radio 1 (Bluetooth-+) transmitter parameters:• Frequency (range): 2.45 GHz (2.4 – 2.5 GHz)• Bandwidth : 1 MHz• Channel: 5 logical channels• Modulation: FHSS/GFSK, π/4 DPSK, 8DPSK• Radiated output power: 2.5 mW / +4 dBm• Magnetic field strength: N/A• Duty Cycle: 100 % (averaged over 1 hour of operation)• Time division duplex (TDD)

M-DEX radio 2 transmitter parameters:• Frequency (range): 10.6 MHz (10.2 – 11.0 MHz)• Bandwidth (-15dB): 660 kHz• Channel: Single channel radio• Modulation: FSK• Radiated output power: 8 nW / -51 dBm• Magnetic field strength: -11 dBμA/m @ 10 m• Duty Cycle: 100 % (averaged over 1 hour of operation)• Simplex or semi duplex capability

The radio receivers in the M-DEX are using the same frequency and bandwidth as the corresponding transmitter.

Cables and transducers: The M-DEX is using a standard 3.5 mm jack to 3.5 mm jack cable for audio input signal.

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Quality of Service for Wireless Technology in the WidexLink System WidexLink wireless technology enables communication between two partners of a binaural pair of CLEAR hearing aids and with their matched external devices. The requirements for the quality of ser-vice (QoS) vary among the various components and their intended user scenarios.

During daily use, the requirements on audio streaming between hearing aids include a BER better than 10-3. The communication is simplex with a bitrate of 212 kbits/s. The additional audio decoding in this mode results in a longer latency which is less than 10 ms. For remote control commands the QoS requirements include a BER bet-ter than 10-2. The lower BER requirement results from redundant transmissions. Each key press results in transmissions of 7 data packages of which only one is needed for a successful communica-tion.

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Wireless Security Measures Security of the wireless signals is assured through device system de-sign that includes:

• Individual MAC address for each unit which is checked during each transmission.

• A built-in pairing table which specifies valid and legitimate pairing among units

• A proprietary Widex communication protocol which checks the package numbers during each transmission.

• A Cyclic Redundancy Check (CRC) to check data validity and correct errors.

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Guidance and manufacturer’s declaration

Electromagnetic emissions The M-DEX is intended for use in the electromagnetic environment specified below. The customer or the user of a M-DEX should assure that it is used in such an environment.

Emissions test

Compliance Electromagnetic environment - guidance

RF emissionsCISPR 11

Group 2 The M-DEX must emit electro-magnetic energy in order to per-form its intended function. Nearby electronic equipment may be af-fected.

RF emissionsCISPR 11

Class B The M-DEX is suitable for use in all establishments, including do-mestic establishments and those directly connected to the public low-voltage power supply net-work that supplies buildings used for domestic purposes.

Harmonic emissionsIEC61000-3-2

Not applicable *)

Voltage fluc-tuations/ flicker emis-sionsIEC 61000-3-3

Not applicable *)

*) Battery powered equipment

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Electromagnetic immunityThe M-DEX is intended for use in the electromagnetic environment specified below. The customer or the user of a M-DEX should assure that it is used in such an environment.

Immunity Test

IEC 60601Test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD)IEC 61000-4-2

± 6 kV con-tact± 8 kV air

± 6 kV con-tact± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic ma-terial, the relative humidity should be at least 30 %.

Electrical fast tran-sients/burstIEC 61000-4-4

± 2 kV for power line supplies± 1 kV for in-put/output lines

Not applicable *)

SurgeIEC 61000-4-5

± 1 kV line(s) to line(s)± 2 kV line(s) to earth

Not applicable *)

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Voltage dips, short inter-ruptions and voltage variations on power sup-ply input linesIEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles<5 % UT (>95 % dip in UT) for 5 s

Not applicable *)

Power fre-quency (50/60 Hz) magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commer-cial or hospital en-vironment

NOTE UT is the a.c. mains voltage prior to the application of the test level.

*) Battery powered equipment

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Electromagnetic immunity – cont.The M-DEX is intended for use in the electromagnetic environment specified below. The customer or the user of a M-DEX should assure that it is used in such an environment.

Immunity Test

IEC 60601Test level

Compli-ance level

Electromagnetic environ-ment – guidance

Portable and mobile RF communications equip-ment should be used no closer to any part of the M-DEX, including cables, than the recommended separa-tion distance calculated from the equation applica-ble to the frequency of the transmitter.

Conduct-ed RFIEC61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

Recommended separation distance

d = 1.2 √P

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Immunity Test

IEC 60601Test level

Compli-ance level

Electromagnetic environ-ment – guidance

Radiated RFIEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m d = 1.2 √P 80 MHz to 800 MHz

d = 2.3 √P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmit-ter manufacturer and d is the recommended separa-tion distance in metres (m).

Field strengths from fixed RF transmitters, as deter-mined by an electromag-netic site survey a, should be less than the compli-ance level in each frequen-cy √P range b. Interference may occur in the vicinity of equipment marked with the following symbol:

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NOTE 1 At 80 MHz and 800 MHz, the higher frequency range ap-plies.

NOTE 2 These guidelines may not apply in all situations. Electro-magnetic 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, ama-teur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro-magnetic environment due to fixed RF transmitters, an electro-magnetic site survey should be considered. If the measured field strength in the location in which the M-DEX is used exceeds the applicable RF compliance level above, the M-DEX should be ob-served to verify normal operation. If abnormal performance is ob-served, additional measures may be necessary, such as re-orient-ing or re-locating the M-DEX.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances

Recommended separation distances between portable and mobile RF communication equipment and the M-DEX.

The M-DEX is intended for use in the electromagnetic environment in which RF disturbances are controlled. The customer or the user of the M-DEX can help prevent electromagnetic interference by main-taining a minimum distance between portable and mobile RF com-munications equipment (transmitters) and the M-DEXs as recom-mended below, according to the maximum output power of the communications equipment.

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Rated maximum output power of

transmitterW

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

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 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 man-ufacturer.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2 These guidelines may not apply in all situations. Electro-magnetic propagation is affected by absorption and reflection from structures, objects and people.

This M-DEX may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements.

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EMC/EMI ComplianceThe M-DEX complies with the following EMC/EMI standards.

Standard Test type Note

47 CFR Part 15, subpart C

RF emissions USA Federal Communications Commission (FCC) require-ments for intentional radiators.

EN 303 330-2 V1.3.1

RF emissions incl. Spurious emission

EMC and radio spectrum mat-ters for Short Range Devices in the frequency range 9 kHz – 25 MHz

EN 300 328 V1.7.1

RF emissions incl. Spurious emission

EMC and radio spectrum mat-ters for Wideband transmission systems in the 2.4GHz ISM band and using wide band modulation techniques.

IEC 60601-1-2:2007

EMC emissionImmunity, RF and ESD

Medical electrical equipment.General requirements for basic safety and essential perform-ance. Electromagnetic compatibility.

EN 301 489-3 V1.4.1

Immunity, RF and ESD

Standard for Low Power Trans-mitters in the frequency range 9 kHz – 40 GHz

EN 301 489-17 V2.1.1

Immunity, RF and ESD

Standard for 2.4 GHz Wide-band Transmitters

Important notice for prospective hearing aid users Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing

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aid. Licensed physicians who specialize in diseases of the ear are of-ten referred to as otolaryngologists, otologists, or otorhinolaryngol-ogists. The purpose of medical evaluation is to assure that all medi-cally treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.

Following the medical evaluation, the physician will give you a writ-ten statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation.

The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dis-penser to select and fit a hearing aid to your individual needs.

If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nom-inal fee after which you may decide if you want to purchase the hearing aid.

Federal law restricts the sale of hearing aids to those individuals 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 beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.

Children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evalua-tion and rehabilitation since hearing loss may cause problems in lan-guage development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

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FCC ID: TTY-MDEXIC: 5676B-MDEX

This device contains:

FCC ID: TTY092802IC: 5676B-092802

Federal Communications Commission Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

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— Reorient or relocate the receiving antenna.— Increase the separation between the equipment and

receiver.— Connect the equipment into an outlet on a circuit

different from that to which the receiver is connected.— Consult the dealer or an experienced radio/TV

technician for help.

NOTE: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Changes or modifications to the equipment not expressly approved by Widex could void the user’s authority to operate the equipment.

Industry Canada Statement / Déclaration d’industrie Canada

Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:

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(1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour l’émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à l’intention des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensité nécessaire à l’établissement d’une communication satisfaisante.

Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes:

(1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.

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Hereby, Widex A/S declares that this M-DEX is in com-pliance with the essential requirements and other rele-vant provisions of Directive 1999/5/EC.

A copy of the Declaration of Conformity can be found at: http://www.widex.com

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Hearing aids, accessories and batteries should not be disposed of with normal household waste. Please consult your na-tional Widex distributor for advice on how to dispose of these items.

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Manufacturer

CIB202/0411

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