Widex A S CMDEX Wireless headset for hearing aid User Manual 9 514 0313 080 booklet indb

Widex A/S Wireless headset for hearing aid 9 514 0313 080 booklet indb

Contents

User manual -part 2

UK USERINSTRUCTIONS......................................
DE BEDIENUNGSANLEITUNG................................ 
FR MODEDEMPLOI ........................................ 
ES INSTRUCCIONESDEUSO ................................ 
PT INSTRUÇÕESDEUTILIZAÇÃO ............................ 
IT LIBRETTOD’ISTRUZIONI................................. 
JP 取扱説明書
USCA USERINSTRUCTIONS...................................
PB
1
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DESCRIPTION OF DEVICE – See illustration 1
 Pushbutton
 RoomOffbutton
 LED
 Microphone
 Neckloop
 MicroUSB
Note: Read these instructions carefully before you start using the
device.
Intended use
The device is intended to improve the ability of hearing impaired
people to conduct mobile phone conversations while using their
hearing aids, to improve the usability and ease of control of such
hearing aids by equipping them with a Smartphone-based con-
trol method.
Note: The device uses Bluetooth standard which is common in
newer mobile phones.
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ACCESSORIES – See illustration 2
 USBcable
CHARGING – See illustration 3
 ConnectUSBcablebetweenthedeviceandthepower
supplyWerecommendthatthetwonecklooppartsare
notjoinedwhilechargingthedevice
 Redlightcharginggreenlightfullycharged
Batterylifehoursstreamingdaysstandby
HOW TO USE – See illustration 4
 JointhetwonecklooppartsTheneckloopfunctionsas
anonoffswitch
 PairthedevicetoyourmobilephoneusingBluetooth
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How to pair the device with your phone
To pair your device with your phone for the first time, follow these
steps:
 Makesurethatthedeviceandphonearewithinmetre
rangeofeachother
ConnecttheneckloopThedevicewillblinkredandblue
 ActivateBluetoothonyourphone
 Startthepairingprocessaccordingtotheinstructionsinyour
phone’suserguide
 YourphonewillshowalistofBluetoothdevices
SelectCOM-DEXfromthelist
Once you have paired the device, it will remain so even when you
disconnect the neck loop.
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Incoming calls – See illustration 5
 AnswercallPresspushbutton
 Speakintomicrophonewhiledeviceishangingaround
yourneck
 EndcallPresspushbutton
Note: Answering and ending calls is also possible on the mobile
phone. Notethaton some mobile phones youmay need to
selecttheCOM-DEXfromalistofdevicesOtherwisethesound
willbetransmittedthroughthephone’sspeakers
Outgoing calls – See illustration 5
 Dialfromphone
Note: You can also use the device to stream sound from any
sound source to your hearing aids.
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Sound adjustment during use
Volumeisadjustedonthemobilephone
ToshutoutsurroundingsoundspressRoomOffbutton–See
illustration
You can download the COM-DEX app from the App Store or
Google Play. This app allows you to use your phone as a remote
control.
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MAINTENANCE
Clean with a damp cloth. Do not use chemicals.
Do not expose to extreme temperatures or high humidity.
Do not immerse in liquids.
When the device is not in use keep it in a dry location out of
reach of children and pets.
Never try to open or repair the device yourself. This may only
be done by authorised personnel.
INFORMATION ABOUT EMISSION
Emission levels from Widex devices are several times lower than
the levels transmitted by mobile phones and other communica-
tions equipment.
For further information, especially regarding patients with
medical implants, download the document: “Information on
WidexLinkTM” at www.widex.com/widexlink
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TROUBLESHOOTING
Problem Possible cause Solution
The device does not
work
a) Device battery low
b) The mobile phone is
set to silent mode
c) Hearing aid battery
low
d) Out af range
a) Charge device bat-
tery
b) Set to normal
mode
c) Change hearing
aid’s battery
d) Bluetooth has a
range up to 10 m.
No sound a) Not connected via
Bluetooth
a) Repeat the pairing
process
If the problems persist, contact your hearing care professional.
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WARNINGS
WARNING
Do not use the device in mines or other areas with explosive gases.
When the device is connected via micro USB cable to external mains-
operated equipment such as a charger, PC, audio source or similar, this
equipment must comply with IEC 60065, IEC 60950-1, IEC 60601-1 or
equivalent safety standards.
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Hereby, Widex A/S declares that this COM-DEX is in compliance
with the essential requirements and other relevant provisions of
Directive 1999/5/EC.
AcopyoftheDeclarationofConformitycanbefoundat
http://www.widex.com/doc
Symbols commonly used by Widex A/S in medical device labelling
(labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose name
and address are stated next to the symbol. If appropriate,
the date of manufacture may also be stated.
Date of manufacture
The date when the product was manufactured.
Use-by date
The date after which the product is not to be used.
Batch code
The product’s batch code (lot or batch identification).
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Symbols commonly used by Widex A/S in medical device labelling
(labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose name
and address are stated next to the symbol. If appropriate,
the date of manufacture may also be stated.
Date of manufacture
The date when the product was manufactured.
Use-by date
The date after which the product is not to be used.
Batch code
The product’s batch code (lot or batch identification).
SYMBOLS
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Symbol Title/Description
Catalogue number
The product’s catalogue (item) number.
Serial number
The products serial number.*
Keep away from sunlight
The product must be protected from light sources and/or
The product must be kept away from heat
Keep dry
The product must be protected from moisture and/or The
product must be kept away from rain
Lower limit of temperature
The lowest temperature to which the product can be safely
exposed.
Symbol Title/Description
Upper limit of temperature
The highest temperature to which the product can be safely
exposed.
Temperature limits
The highest and lowest temperatures to which the product
can be safely exposed.
Consult instructions for use
The user instructions contain important cautionary infor-
mation (warnings/precautions) and must be read before
using the product.
Caution/Warning
Text marked with a caution/warning symbol must be read
before using the product.
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Symbol Title/Description
Catalogue number
The product’s catalogue (item) number.
Serial number
The products serial number.*
Keep away from sunlight
The product must be protected from light sources and/or
The product must be kept away from heat
Keep dry
The product must be protected from moisture and/or The
product must be kept away from rain
Lower limit of temperature
The lowest temperature to which the product can be safely
exposed.
Symbol Title/Description
Upper limit of temperature
The highest temperature to which the product can be safely
exposed.
Temperature limits
The highest and lowest temperatures to which the product
can be safely exposed.
Consult instructions for use
The user instructions contain important cautionary infor-
mation (warnings/precautions) and must be read before
using the product.
Caution/Warning
Text marked with a caution/warning symbol must be read
before using the product.
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Symbol Title/Description
WEEE mark
“Not for general waste”
When the product is to be discarded, it must be sent to a
designated collection point for recycling and recovery.
CE mark
The product is in conformity with the requirements set out
in European CE marking directives.
Alert
The product is identified by R&TTE Directive 1999/5/EC as
an equipment Class 2 product with some restrictions on use
in some CE member states.
RCM mark
The product complies with electrical safety, EMC and radio
spectrum regulatory requirements for products supplied to
the Australian or New Zealand market.
Symbol Title/Description
Interference
Electromagnetic interference may occur in the vicinity of
the product.
*The six- or seven-digit number on the product is the serial number. Se-
rial numbers may not always be preceded by
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Symbol Title/Description
WEEE mark
“Not for general waste”
When the product is to be discarded, it must be sent to a
designated collection point for recycling and recovery.
CE mark
The product is in conformity with the requirements set out
in European CE marking directives.
Alert
The product is identified by R&TTE Directive 1999/5/EC as
an equipment Class 2 product with some restrictions on use
in some CE member states.
RCM mark
The product complies with electrical safety, EMC and radio
spectrum regulatory requirements for products supplied to
the Australian or New Zealand market.
Symbol Title/Description
Interference
Electromagnetic interference may occur in the vicinity of
the product.
*The six- or seven-digit number on the product is the serial number. Se-
rial numbers may not always be preceded by
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GERÄTEBESCHREIBUNG – Siehe Abbildung 1
 Taste
 Taste„HG-Mikroaus“
 LED
 Mikrofon
 Nackenschlaufe
 Mikro-USB
Bitte beachten: Bitte lesen Sie diese Bedienungsanleitung auf-
merksam durch, ehe Sie das Gerät in Betrieb nehmen.
Bestimmungsgemäßer Gebrauch
Dieses Gerät ist dazu vorgesehen, Personen mit Hörminderung
Mobiltelefonate bei Benutzung Ihrer Hörsysteme zu ermöglichen,
und gleichzeitig die Benutzbarkeit und einfache Einstellbarkeit die-
ser Hörsysteme mit einem Smartphone-basierenden Verfahren zu
verbessern.
Bitte beachten: Das Gerät nutzt den Bluetooth-Übertragungsstan-
dard, der bei neueren Mobiltelefonen üblich ist.
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ZUBEHÖR – Siehe Abbildung 2
 USB-Kabel
AUFLADEN – Siehe Abbildung 3
 DasGerätmitdemUSB-KabelamNetzteilanschließenWir
empfehlendiebeidenNackenschlaufenendenbeimLaden
desGerätsnichtzuverbinden
 RotesLichtlädtaufgrünesLichtvollaufgeladen
AkkulaufzeitStundenDauerbetriebTageStandby
GEBRAUCH – Siehe Abbildung 4
 VerbindenSiedieEndenderNackenschlaufeDieNacken-
schlaufedientauchalsEin-Ausschalter
 KoppelnSiedasGerätüberBluetoothmitIhremMobiltele-
fon
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Das Gerät mit Ihrem Mobiltelefon koppeln
Gehen Sie bei der erstmaligen Kopplung des Gerätes mit Ihrem
Mobiltelefon folgendermaßen vor:
 AchtenSiedaraufdassdasGerätunddasMobiltelefonnicht
weiteralsMetervoneinanderentferntsind
 VerbindenSiedieEndenderNackenschlaufeDasGerätblinkt
rotundblau
 AktivierenSieaufIhremMobiltelefonBluetooth
 StartenSiedieKopplunggemäßderBedienungsanleitung
IhresMobiltelefons
 IhrMobiltelefonzeigteineListemitBluetooth-Gerätenan
WählenSieCOM-DEXausderListe
Die Kopplung bleibt auch dann erhalten, wenn Sie die Nacken-
schlaufe trennen.
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Eingehende Anrufe – Siehe Abbildung 5
 AnrufannehmenDrückenSiedieTaste
 SprechenSieindasMikrofonwährendSiedasGerätum
denHalsgehängthaben
 AnrufbeendenDrückenSiedieTaste
Bitte beachten: Sie können Anrufe auch an Ihrem Mobiltele-
fon annehmen und beenden. Bitte beachten, dass Sie bei eini-
gen Mobiltelefonen COM-DEX aus einer Geräteliste wählen müs-
sen. Ansonsten wird der Ton über den Lautsprecher des Mobilte-
lefons übertragen.
Anrufe tätigen – Siehe Abbildung 5
 WählenSiemitdemMobiltelefon
Bitte beachten: Sie können das Gerät auch für die Übertragung
beliebiger Audioquellen zu Ihren Hörsystemen benutzen (Mono).
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Lautstärkeeinstellung während des Gebrauchs
DieLautstärkewirdamMobiltelefoneingestellt
UmUmgebungsgeräuscheauszublendendrückenSiedieTaste
„HG-Mikroaus“(Mikrofon-Stummschaltung)–SieheAbbildung
Sie können die COM-DEX App im App Store oder über Google Play
herunterladen. Mit dieser App können Sie Ihr Mobiltelefon auch als
Fernbedienung für Ihr Hörsystem nutzen.
AUFBEWAHRUNG UND ALLGEMEINE
HANDHABUNG
Zur Reinigung ein feuchtes Tuch benutzen. Keine Chemikalien
verwenden.
Setzen Sie das Gerät keinen extremen Temperaturen oder star-
ker Feuchtigkeit aus.
Bringen Sie das Gerät nicht mit Wasser oder anderen Flüssigkei-
ten in Berührung.
Wenn Sie das Gerät nicht benutzen, bewahren Sie es an einem
trockenen Ort und für Kinder und Haustiere unzugänglich auf.
Versuchen Sie nie, das Gerät selbst zu öffnen bzw. zu reparieren,
sondern bringen Sie es zu Ihrem Hörgeräte-Akustiker.
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INFORMATIONEN ZU EMISSIONEN
Die Emissionswerte von Widex Geräten betragen nur ein Bruch-
teil der Emissionen von Mobiltelefonen und anderen Kommunika-
tionsanlagen.
Für weitere Informationen besonders zu Patienten mit medizi-
nischen Implantaten laden Sie bitte dieses Dokument herunter:
“Informationen über WidexLinkTM” auf www.widex.com/widexlink
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FEHLERSUCHE UND -BEHEBUNG
Problem Mögliche Ursache Lösung
Das Gerät funktio-
niert nicht
a) Geräte Akku ist fast
leer
b) Das Mobiltelefon ist
stumm geschaltet
c) Hörsystem-Batterie
ist fast leer
d) Gerät außer Reich-
weite
a) Geräte-Akku aufla-
den
b) Normale Laut-
stärke einstellen
c) Hörsystem-Batte-
rie wechseln
d) Bluetooth hat eine
Reichweite bis zu
10 m.
Kein Ton a) Keine Verbindung
über Bluetooth
a) Kopplung wieder-
holen
Besteht das jeweilige Problem weiterhin, suchen Sie bitte Ihren
Hörgeräte-Akustiker auf.
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WARNHINWEISE
WARNUNG
Aufgrund der einschlägigen Vorschriften darf das Gerät nicht in explosi-
onsgefährdeten Räumen betrieben werden.
Wenn das Gerät über ein Mikro-USB-Kabel mit einem netzbetriebenen
externen Gerät (z.B. Ladegerät, PC, Audiogerät o.Ä.) verbunden wird,
muss dieses Gerät die Sicherheitsvorschriften der Normen IEC 60065, IEC
60950-1, IEC 60601-1 oder vergleichbarer Normen erfüllen.
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Hiermit erklärt Widex A/S, dass sich dieses COM-DEX Gerät in
Übereinstimmung mit den grundlegenden Anforderungen und den
anderen relevanten Vorschriften der Richtlinie 1999/5/EG befindet.
EineKopiederKonformitätserklärungfindenSieauf
http://www.widex.com/doc
Gemeinhin von Widex A/S für die Kennzeichnung medizinischer Geräte
(auf Labels, in Bedienungsanleitungen etc.) verwendete Symbole:
Symbol Bezeichnung/Beschreibung
Hersteller
Der Name und die Adresse des Herstellers des Produktes
stehen neben dem Symbol. Falls erforderlich kann auch
das Herstellungsdatum angegeben sein.
Herstellungsdatum
Das Herstellungsdatum des Produktes.
Verwendbar bis
Das Datum, nach welchem das Produkt nicht mehr ver-
wendet werden darf.
Chargenbezeichnung
Die Chargenbezeichnung des Produktes (Los- oder Char-
gennummer).
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Gemeinhin von Widex A/S für die Kennzeichnung medizinischer Geräte
(auf Labels, in Bedienungsanleitungen etc.) verwendete Symbole:
Symbol Bezeichnung/Beschreibung
Hersteller
Der Name und die Adresse des Herstellers des Produktes
stehen neben dem Symbol. Falls erforderlich kann auch
das Herstellungsdatum angegeben sein.
Herstellungsdatum
Das Herstellungsdatum des Produktes.
Verwendbar bis
Das Datum, nach welchem das Produkt nicht mehr ver-
wendet werden darf.
Chargenbezeichnung
Die Chargenbezeichnung des Produktes (Los- oder Char-
gennummer).
SYMBOLE
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Symbol Bezeichnung/Beschreibung
Bestellnummer
Die Bestellnummer (Artikelnummer) des Produktes.
Seriennummer
Die Seriennummer des Produktes.*
Vor Sonneneinstrahlung schützen
Das Produkt vor Lichtquellen schützen und/oder das Pro-
dukt von Hitze fernhalten.
Vor Nässe sctzen
Das Produkt vor Feuchtigkeit schützen und/oder das Pro-
dukt nicht dem Regen aussetzen.
Untere Temperaturbegrenzung
Tiefsttemperatur, der ein Produkt sicher ausgesetzt wer-
den kann.
Symbol Bezeichnung/Beschreibung
Obere Temperaturbegrenzung
chsttemperatur, der ein Produkt sicher ausgesetzt wer-
den kann.
Temperaturbegrenzung
Temperaturgrenzwerte, denen ein Produkt sicher ausge-
setzt werden kann.
Bedienungsanleitung beachten
Die Bedienungsanleitung enthält wichtige Warnhinweise
und Informationen zu Vorsichtsmaßnahmen und muss vor
Gebrauch des Produktes gelesen werden.
Vorsicht/Warnung
Hinweise mit diesem Symbol müssen vor Gebrauch des
Produktes gelesen werden.
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Symbol Bezeichnung/Beschreibung
Bestellnummer
Die Bestellnummer (Artikelnummer) des Produktes.
Seriennummer
Die Seriennummer des Produktes.*
Vor Sonneneinstrahlung schützen
Das Produkt vor Lichtquellen schützen und/oder das Pro-
dukt von Hitze fernhalten.
Vor Nässe sctzen
Das Produkt vor Feuchtigkeit schützen und/oder das Pro-
dukt nicht dem Regen aussetzen.
Untere Temperaturbegrenzung
Tiefsttemperatur, der ein Produkt sicher ausgesetzt wer-
den kann.
Symbol Bezeichnung/Beschreibung
Obere Temperaturbegrenzung
chsttemperatur, der ein Produkt sicher ausgesetzt wer-
den kann.
Temperaturbegrenzung
Temperaturgrenzwerte, denen ein Produkt sicher ausge-
setzt werden kann.
Bedienungsanleitung beachten
Die Bedienungsanleitung enthält wichtige Warnhinweise
und Informationen zu Vorsichtsmaßnahmen und muss vor
Gebrauch des Produktes gelesen werden.
Vorsicht/Warnung
Hinweise mit diesem Symbol müssen vor Gebrauch des
Produktes gelesen werden.
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Symbol Bezeichnung/Beschreibung
EEAG-Kennzeichnung
„Nicht im Hausmüll entsorgen.
Das Produkt muss zu einer vorgesehenen Sammelstelle
r elektronische Altgeräte gebracht und fachgerecht ent-
sorgt werden.
CE-Kennzeichnung
Das Produkt befindet sich in Übereinstimmung mit den
Anforderungen der europäischen Richtlinien zur CE-Kenn-
zeichnung.
Achtung
Die Richtlinie 1999/5/EG (F&TEE) identifiziert dieses Pro-
dukt als ein Produkt der Geräteklasse 2 mit bestimmten
Gebrauchseinschränkungen in manchen Ländern, in denen
die CE-Kennzeichnung gilt.
Symbol Bezeichnung/Beschreibung
RCM Zeichen
Das Produkt entspricht hinsichtlich der elektrischen
Sicherheit, der EMV und des Funkfrequenzspektrums den
regulatorischen Anforderungen an Produkte, die für den
australischen und neuseeländischen Markt bestimmt sind.
Interferenz
In der Nähe des Produktes können elektromagnetische
Interferenzen auftreten.
* Der sechs- oder siebenstellige Code am Produkt ist die Seriennummer.
Nicht in allen Fällen steht der Seriennummer voran.
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Symbol Bezeichnung/Beschreibung
EEAG-Kennzeichnung
„Nicht im Hausmüll entsorgen.
Das Produkt muss zu einer vorgesehenen Sammelstelle
r elektronische Altgeräte gebracht und fachgerecht ent-
sorgt werden.
CE-Kennzeichnung
Das Produkt befindet sich in Übereinstimmung mit den
Anforderungen der europäischen Richtlinien zur CE-Kenn-
zeichnung.
Achtung
Die Richtlinie 1999/5/EG (F&TEE) identifiziert dieses Pro-
dukt als ein Produkt der Geräteklasse 2 mit bestimmten
Gebrauchseinschränkungen in manchen Ländern, in denen
die CE-Kennzeichnung gilt.
Symbol Bezeichnung/Beschreibung
RCM Zeichen
Das Produkt entspricht hinsichtlich der elektrischen
Sicherheit, der EMV und des Funkfrequenzspektrums den
regulatorischen Anforderungen an Produkte, die für den
australischen und neuseeländischen Markt bestimmt sind.
Interferenz
In der Nähe des Produktes können elektromagnetische
Interferenzen auftreten.
* Der sechs- oder siebenstellige Code am Produkt ist die Seriennummer.
Nicht in allen Fällen steht der Seriennummer voran.
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DESCRIPTION DU DISPOSITIF – Voir l’illustration 1
 Boutonpoussoir
 Boutonpourlacoupuredesmicrophones
 Voyant
 Microphone
 Tourdecou
 MicroUSB
Remarque : Veuillez lire attentivement ce mode d’emploi avant de
commencer à utiliser le dispositif.
Usage auquel ce dispositif est destiné
Ce dispositif est destiné à améliorer la capacité des personnes
malentendantes à passer et recevoir des appels depuis leur télé-
phone portable, via leurs aides auditives. Il permet d’améliorer la
fonctionnalité et le contrôle de leurs aides auditives par une appli-
cation disponible pour Smartphone.
Remarque : Le dispositif utilise la norme Bluetooth, courante dans
les téléphones portables récents.
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LES ACCESSOIRES – Voir l’illustration 2
 CâbleUSB
LE CHARGEMENT – Voir l’illustration 3
 ConnecterlecâbleUSBentreledispositifetl’alimentation
électriqueNousrecommandonsquelesdeuxpartiesdu
tourdecounesoientpasreliéespendantlechargementde
l’appareil
 Voyantrougechargementvoyantvertchargecomplète
Autonomiedelapileheuresdetransmissionjoursen
veille
COMMENT L’UTILISER – Voir l’illustration 4
 RelierlesdeuxpartiesdutourdecouLetourdecoufonc-
tionneteluninterrupteurmarchearrêt
 Appairezledispositifàvotretéléphoneportableàl’aidedu
Bluetooth
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33
Comment appairer le dispositif à votre téléphone ?
Lorsque vous appairez le dispositif à votre téléphone pour la pre-
mière fois, veuillez suivre ces étapes :
 Assurez-vousquel’appareiletletéléphonenesontpaséloi-
gnésdeplusd’unmètrel’undel’autre
 ConnectezletourdecouLedispositifclignoteraavecune
lumièrerougeetbleue
 ActivezleBluetoothsurvotretéléphone
 Démarrezleprocessusd’appairageensuivantlesinstructions
delanoticed’utilisationdevotretéléphone
 Votretéléphoneafficheraunelisted’appareilsBluetooth
DanslalistesélectionnezCOM-DEX
Lorsque vous aurez appairé le dispositif, il restera ainsi même
quand vous déconnecterez le tour de cou.
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Appels entrants – Voir l’illustration 5
 Répondreàl’appelAppuyezsurleboutonpoussoir
 Parlezdanslemicrophonelorsqueledispositifestsuspendu
autourdevotrecou
 Terminerl’appelAppuyezsurleboutonpoussoir
Remarque : Vous pouvez également prendre un appel et raccro-
cher sur le téléphone portable. Veuillez noter que, sur certains télé-
phones portables, il se peut que vous deviez sélectionner le COM-
DEX dans une liste d’appareils. Sinon, le son sera transmis par les
haut-parleurs du téléphone
Appels sortants – Voir l’illustration 5
 Composerunnumérodepuisletéléphone
Remarque : Vous pouvez également utiliser le dispositif pour
transmettre le son de n’importe quelle source sonore vers vos aides
auditives.
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35
Réglage du son pendant l’utilisation
Levolumeserèglesurletéléphoneportable
PourexclurelessonsenvironnantsappuyezsurleboutonCou-
puredesmicrophones–Voirl’illustration
Vous pouvez télécharger l’application COM-DEX depuis l’App Store
ou Google Play. Cette application vous permet d’utiliser votre télé-
phone tel une radiocommande.
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L’ENTRETIEN
Nettoyez-le avec un chiffon humide. N’utilisez pas de produits
chimiques.
Ne l’exposez pas à des températures extrêmes ou à une forte
humidité.
Ne l’immergez pas dans un liquide.
Lorsque vous n’utilisez pas le dispositif, rangez-le dans un
endroit sec, hors de portée des enfants et des animaux domes-
tiques.
N’essayez jamais d’ouvrir ou de réparer vous-même le dispositif.
Cela doit être fait par du personnel habilité uniquement.
INFORMATIONS SUR LES ÉMISSIONS
Les niveaux d’émissions des appareils Widex sont plusieurs fois
inférieurs à ceux transmis par les téléphones portables et autres
équipements de communication.
Pour plus d’informations, particulièrement pour les patients avec
des implants médicaux, veuillez télécharger le document :
“Information on WidexLinkTM” sur www.widex.com/widexlink
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PROBLÈMES ET SOLUTIONS
Problème Cause possible Solution
L’appareil ne fonc-
tionne pas
a) La pile de l’appareil
est épuisée
b) Le téléphone por-
table est en mode
silencieux
c) La pile de l’aide
auditive est épuisée
d) Hors de portée
a) Chargez la pile de
l’appareil
b) Mettez-le en mode
normal
c) Changez la pile de
l’aide auditive
d) Bluetooth a une
portée de 10 m.
Pas de son a) Pas connecté via
Bluetooth
a) Recommencez le
processus d’appai-
rage
Si les problèmes persistent, contactez votre audioprothésiste.
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AVERTISSEMENTS
AVERTISSEMENTS
N’utilisez pas le dispositif dans des mines ou d’autres lieux contenant des
gaz explosifs.
Lorsque le dispositif est connecté via un câble micro USB à du matériel
alimenté sur secteur comme un chargeur, un PC, une source audio ou
tout autre appareil semblable, ce matériel doit répondre aux normes CEI
60065, CEI 60950-1, CEI 60601-1 ou à toute autre norme équivalente.
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Par le présent, Widex A/S déclare que ce COM-DEX est conforme
aux exigences essentielles et aux autres dispositions pertinentes
de la directive 1999/5/CE.
Voustrouverezunecopiedeladéclarationdeconformitésur
http://www.widex.com/doc
Symboles communément utilisés par Widex A/S pour l’étiquetage des
dispositifs médicaux (étiquettes, instructions d’utilisation, etc.)
Symbole Titre/Description
Fabricant
Le produit est fabriqué par le fabricant dont le nom et
l'adresse sont mentionnés à côté du symbole. Le cas
échéant, la date de fabrication est également mentionnée.
Date de fabrication
La date à laquelle le produit a été fabriqué.
Date limite d'utilisation
La date après laquelle le produit ne doit pas être utilisé.
Nuro de lot
Le nuro de lot du produit (identification du lot).
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Symboles communément utilisés par Widex A/S pour l’étiquetage des
dispositifs médicaux (étiquettes, instructions d’utilisation, etc.)
Symbole Titre/Description
Fabricant
Le produit est fabriqué par le fabricant dont le nom et
l'adresse sont mentionnés à côté du symbole. Le cas
échéant, la date de fabrication est également mentionnée.
Date de fabrication
La date à laquelle le produit a été fabriqué.
Date limite d'utilisation
La date après laquelle le produit ne doit pas être utilisé.
Nuro de lot
Le nuro de lot du produit (identification du lot).
LES SYMBOLES
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41
Symbole Titre/Description
Référence
La référence du produit.
Numéro de série
Le numéro de série du produit.*
Ne pas exposer au rayonnement solaire
Le produit doit être conservé à l'abri de la lumière et/ou
le produit ne doit pas être exposé à la chaleur.
Tenir au sec
Le produit doit être conservé à l'abri de toute humidité et/
ou le produit ne doit pas être exposé à la pluie.
Température inférieure limite
La température la plus basse à laquelle le produit peut être
exposé sans risque.
Symbole Titre/Description
Température supérieure limite
La température la plus élevée à laquelle le produit peut
être exposé sans risque.
Limites de températures
Les températures les plus basses et les plus élevées aux-
quelles le produit peut être exposé sans risque.
Consulter le mode d’emploi
Le mode d'emploi comprend d'importantes informations
(avertissements/précautions) qui doivent être lues avant
d'utiliser le produit.
Mise en garde/Avertissement
Les textes indiqs par un symbole d'avertissement/mise
en garde doivent être lus avant d'utiliser le produit.
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Symbole Titre/Description
Référence
La référence du produit.
Numéro de série
Le numéro de série du produit.*
Ne pas exposer au rayonnement solaire
Le produit doit être conservé à l'abri de la lumière et/ou
le produit ne doit pas être exposé à la chaleur.
Tenir au sec
Le produit doit être conservé à l'abri de toute humidité et/
ou le produit ne doit pas être exposé à la pluie.
Température inférieure limite
La température la plus basse à laquelle le produit peut être
exposé sans risque.
Symbole Titre/Description
Température supérieure limite
La température la plus élevée à laquelle le produit peut
être exposé sans risque.
Limites de températures
Les températures les plus basses et les plus élevées aux-
quelles le produit peut être exposé sans risque.
Consulter le mode d’emploi
Le mode d'emploi comprend d'importantes informations
(avertissements/précautions) qui doivent être lues avant
d'utiliser le produit.
Mise en garde/Avertissement
Les textes indiqs par un symbole d'avertissement/mise
en garde doivent être lus avant d'utiliser le produit.
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Symbole Titre/Description
Marquage DEEE
"Ne pas jeter avec les ordures ménares ordinaires"
Lorsque vous devez jeter le produit, il doit être envoyé dans
un point de collecte officiel afin d'être recyclé et valorisé.
Marquage CE
Le produit est conforme aux exigences définies dans les
directives euroennes sur le marquage CE.
Alerte
Le produit est identifié par la directive RTTE 1999/5/CE
comme un équipement de Classe 2 avec quelques restric-
tions d'utilisation dans certains pays membres de la CE.
Marque RCM
Le produit est conforme aux exigences réglementaires
relatives à la CME et au spectre radioélectrique pour les
produits destinés au marché australien ou néozélandais.
Symbole Titre/Description
Interférence
Il peut se produire des interférences électromagnétiques à
proximité du produit.
*Les six ou sept chiffres indiqs sur le produit correspondent au numéro
de série. Les numéros de série ne sont pas toujours précés de
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Symbole Titre/Description
Marquage DEEE
"Ne pas jeter avec les ordures ménares ordinaires"
Lorsque vous devez jeter le produit, il doit être envoyé dans
un point de collecte officiel afin d'être recyclé et valorisé.
Marquage CE
Le produit est conforme aux exigences définies dans les
directives euroennes sur le marquage CE.
Alerte
Le produit est identifié par la directive RTTE 1999/5/CE
comme un équipement de Classe 2 avec quelques restric-
tions d'utilisation dans certains pays membres de la CE.
Marque RCM
Le produit est conforme aux exigences réglementaires
relatives à la CME et au spectre radioélectrique pour les
produits destinés au marché australien ou néozélandais.
Symbole Titre/Description
Interférence
Il peut se produire des interférences électromagnétiques à
proximité du produit.
*Les six ou sept chiffres indiqs sur le produit correspondent au numéro
de série. Les numéros de série ne sont pas toujours précés de
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DESCRIPCIÓN DEL DISPOSITIVO: vea la ilustración 1
 Teclapulsadora
 TeclaDesconexiónacústica
 LED
 Micrófono
 Cordóninductivo
 MicroUSB
Nota: lea atentamente estas instrucciones antes de empezar a
utilizar el dispositivo.
Utilización prevista
El dispositivo ha sido desarrollado para mejorar la habilidad de
las personas con pérdida auditiva de mantener conversaciones
mediante teléfonos móviles mientras utilizan sus audífonos, y
para mejorar el uso y el control de dichos audífonos ofreciendo al
usuario un método de control por Smartphone.
Nota: el dispositivo utiliza una conexión Bluetooth estándar que
es común en los teléfonos móviles más recientes.
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ACCESORIOS: vea la ilustración 2
 CableUSB
CARGA: vea la ilustración 3
 ConecteelcableUSBaldispositivoyalsuministrode
energíaRecomendamostenerdesconectadoelcordón
inductivomientrascargaeldispositivo
 Diodorojocargandodiodoverdecargado
Vidaútildelapilahorasdeusodíasenreposo
UTILIZACIÓN: vea la ilustración 4
 Conectelasdospiezasdelcordóninductivo
Elcordóninductivofuncionacomointerruptor
 Emparejeeldispositivoasuteléfonomóvilmediante
Bluetooth
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47
Cómo emparejar el dispositivo con el móvil
Para emparejar el móvil con el dispositivo por primera vez, siga
estos pasos:
 Asegúresedequeelmóvilyeldispositivoesnamenosde
metrodedistanciaentreellos
 ConecteelcordóninductivoElLEDdeldispositivopapa-
deará(luzrojayazul)
 ActiveBluetoothensuteléfono
 Inicieelprocesodeemparejamientosiguiendolaspautasde
lasinstruccionesdeusodesumóvil
 SuteléfonomostraráunalistadedispositivosconBluetooth
SeleccioneCOM-DEXenlalista
Una vez emparejados el dispositivo y el móvil, ambos per-
manecerán emparejados aunque desconecte el cordón inductivo.
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Recibir llamadas: vea la ilustración 5
 Responderllamadautilicelateclapulsadora
 Hableenelmicrófonodeldispositivomientraslollevacol-
gadoalcuello
 Finalizarllamadautilicelateclapulsadora
Nota: también puede responder y finalizar llamadas utilizando las
teclas pertinentes en su móvil. Tenga en cuenta que, con algunos
móviles, deberá elegir el dispositivo COM-DEX en una lista de dis-
positivos. De no ser así, el sonido será transmitido a través de los
altavoces del móvil.
Realizar llamadas: vea la ilustración 5
 Marqueelnúmeroensumóvil
Nota: también puede utilizar el dispositivo para transmitir sonido
de cualquier fuente a sus audífonos.
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49
Ajuste del sonido durante el uso
Elvolumenseajustaenelteléfonomóvil
ParaeliminarlossonidosdelentornopulselateclaDesconex-
iónacústicavealailustración
Puede descargar la aplicación COM-DEX en App Store, o Google
Play. Esta aplicación le permite utilizar el móvil como control
remoto para sus audífonos.
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MANTENIMIENTO
Limpie el dispositivo con un paño húmedo. No utilice produc-
tos químicos.
No lo exponga nunca el dispositivo a temperaturas extremas
o a humedad.
No lo sumerja en líquidos.
Cuando no utilice el dispositivo, guárdelo en un lugar seco,
fuera del alcance de los niños o animales domésticos.
No intente nunca desmontar o reparar el dispositivo usted
mismo. El dispositivo solo deber ser desmontado o reparado
por personas autorizadas.
INFORMACIÓN SOBRE EMISIONES
Los niveles de emisión de los dispositivos Widex son mucho más
bajos que los niveles transmitidos por los teléfonos móviles y
otros equipos de comunicación.
Si desea ver más información en especial para pacientes con
implantes médicos, descargue el documento: “Information on
WidexLinkTM” at www.widex.com/widexlink
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SOLUCIÓN DE PROBLEMAS
Problema Causa posible Solución
El dispositivo no fun-
ciona
a) Batería del disposi-
tivo agotada
b) El móvil está en el
modo silenciado
c) Pila del audífono
agotada
d) Fuera del radio de
acción
a) Cargue la batería
del dispositivo
b) Ajuste el móvil al
modo normal
c) Cambie la pila del
audífono
d) Bluetooth tiene un
radio de acción de
hasta 10 m.
No hay sonido a) No hay conexión
por Bluetooth
a) Repita el proceso
de emparejami-
ento
Si persisten los problemas, póngase en contacto con el audiopro-
tesista.
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ADVERTENCIAS
ADVERTENCIA
No use nunca el dispositivo en minas u otras zonas con gases explo-
sivos.
Si conecta el dispositivo mediante un cable micro USB a un equipo
externo conectado a la red de suministro, dicho equipo debe cumplir
los requisitos establecidos en los esndares de seguridad IEC-60065,
IEC 60950, IEC-60601-1 u otros equivalentes.
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53
Por medio de la presente Widex A/S declara que este COM-DEX
cumple con los requisitos esenciales y cualesquiera otras disposi-
ciones aplicables o exigibles de la Directiva 1999/5/CE.
PuedeverunacopiadelaDeclaracióndeconformidaden
http://www.widex.com/doc
Éstos son los símbolos utilizados habitualmente por Widex para el eti-
quetado de productos sanitarios (etiquetas, instrucciones de uso, etc.)
Símbolo Título/descripción
Fabricante
El producto ha sido producido por el fabricante cuyo nom-
bre y dirección se indican al lado del símbolo. Si procede,
también se puede indicar la fecha de fabricación.
Fecha de fabricación
La fecha de fabricación del producto.
Fecha de caducidad
La fecha tras la cual no se debe utilizar el producto.
mero de lote
El número de lote del producto (la identificación de partida
o lote).
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53
Éstos son los símbolos utilizados habitualmente por Widex para el eti-
quetado de productos sanitarios (etiquetas, instrucciones de uso, etc.)
Símbolo Título/descripción
Fabricante
El producto ha sido producido por el fabricante cuyo nom-
bre y dirección se indican al lado del símbolo. Si procede,
también se puede indicar la fecha de fabricación.
Fecha de fabricación
La fecha de fabricación del producto.
Fecha de caducidad
La fecha tras la cual no se debe utilizar el producto.
mero de lote
El número de lote del producto (la identificación de partida
o lote).
SÍMBOLOS
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55
Símbolo Título/descripción
Número de catálogo
El número de catálogo del producto (arculo).
Número de serie
El número de serie del producto.*
No exponer a la luz solar
No se debe exponer el producto a fuentes de luz y/o Man-
tener el producto alejado de cualquier fuente de calor
Mantener seco
Se debe proteger el producto de la humedad y/o El pro-
ducto debe ser protegido contra la lluvia
Límite inferior de temperatura
La temperatura más baja a la que puede ser expuesto el
producto sin riesgos.
Símbolo Título/descripción
Límite superior de temperatura
La temperatura más alta a la que puede ser expuesto el
producto sin riesgos.
Límites de temperatura
Las temperaturas más altas y más bajas a las que puede
ser expuesto el producto sin riesgos.
Consultar las instrucciones de uso
Las instrucciones de uso contienen información cautelar
importante (avisos/precauciones) y es necesario leerlas
antes de utilizar el producto.
Aviso/Advertencia
Se debe leer todo texto marcado con un símbolo de aviso/
advertencia antes de usar el producto.
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55
Símbolo Título/descripción
Número de catálogo
El número de catálogo del producto (arculo).
Número de serie
El número de serie del producto.*
No exponer a la luz solar
No se debe exponer el producto a fuentes de luz y/o Man-
tener el producto alejado de cualquier fuente de calor
Mantener seco
Se debe proteger el producto de la humedad y/o El pro-
ducto debe ser protegido contra la lluvia
Límite inferior de temperatura
La temperatura más baja a la que puede ser expuesto el
producto sin riesgos.
Símbolo Título/descripción
Límite superior de temperatura
La temperatura más alta a la que puede ser expuesto el
producto sin riesgos.
Límites de temperatura
Las temperaturas más altas y más bajas a las que puede
ser expuesto el producto sin riesgos.
Consultar las instrucciones de uso
Las instrucciones de uso contienen información cautelar
importante (avisos/precauciones) y es necesario leerlas
antes de utilizar el producto.
Aviso/Advertencia
Se debe leer todo texto marcado con un símbolo de aviso/
advertencia antes de usar el producto.
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Símbolo Título/descripción
Marca RAEE (WEEE)
"No tire el dispositivo a la basura"
A la hora de eliminar el producto, éste debe ser enviado
a un punto de recogida designado para su reciclaje y va-
lorización.
Marca CE
El producto está en conformidad con los requisitos esta-
blecidos en las directivas europeas sobre el marcado CE.
Alerta
El producto está identificado por la Directiva R&TTE
1999/5/EC como un equipo de Clase 2, con algunas res-
tricciones de uso aplicables en algunos Estados miembros
de la UE.
Símbolo Título/descripción
Marca RCM
El producto cumple con los requisitos reguladores de se-
guridad eléctrica, compatibilidad electromagnética (EMC)
y de espectro de radio establecidos para los productos su-
ministrados a los mercados de Australia y Nueva Zelanda.
Interferencia
Pueden producirse interferencias electromagnéticas en las
zonas adyacentes al producto.
El número de seis o siete dígitos indicado en el producto es su número de
serie. El símbolo no siempre precede los números de serie
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Símbolo Título/descripción
Marca RAEE (WEEE)
"No tire el dispositivo a la basura"
A la hora de eliminar el producto, éste debe ser enviado
a un punto de recogida designado para su reciclaje y va-
lorización.
Marca CE
El producto está en conformidad con los requisitos esta-
blecidos en las directivas europeas sobre el marcado CE.
Alerta
El producto está identificado por la Directiva R&TTE
1999/5/EC como un equipo de Clase 2, con algunas res-
tricciones de uso aplicables en algunos Estados miembros
de la UE.
Símbolo Título/descripción
Marca RCM
El producto cumple con los requisitos reguladores de se-
guridad eléctrica, compatibilidad electromagnética (EMC)
y de espectro de radio establecidos para los productos su-
ministrados a los mercados de Australia y Nueva Zelanda.
Interferencia
Pueden producirse interferencias electromagnéticas en las
zonas adyacentes al producto.
El número de seis o siete dígitos indicado en el producto es su número de
serie. El símbolo no siempre precede los números de serie
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DESCRIÇÃO DO DISPOSITIVO – Ver ilustração 1
 Botãodepressão
 BotãoRoomOff
 LED
 Microfone
 Cordãodepescoço
 MicroUSB
Nota: Leia atentamente estas instruções antes de começar a utili-
zar o dispositivo.
Utilização prevista
Este dispositivo destina-se a melhorar as conversas telefónicas
de pessoas com dificuldades de audição enquanto estas utilizam
os seus aparelhos auditivos. Também permite a utilização e uma
maior facilidade de controlo destes aparelhos, ao estarem equipa-
dos com um método de controlo através de smartphones.
Nota: Este dispositivo utiliza Bluetooth padrão, que é comum nos
telemóveis mais recentes.
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ACESSÓRIOS – Ver ilustração 2
 CaboUSB
COMO CARREGAR – Ver ilustração 3
 LigueocaboUSBaodispositivoeàfontedealimentação
Recomenda-sequeasduaspartesdocordãodepescoço
nãoestejamunidasenquantoodispositivoestáacarregar
 Luzvermelhaacarregarluzverdetotalmentecarregado
Autonomiadabateriahorasdetransmissãodedadosdias
emmododeespera
COMO UTILIZAR – Ver ilustração 4
 UnaasduaspartesdocordãodepescoçoOcordãofun-
cionacomointerruptordeligardesligar
 Emparelheodispositivocomoseutelemóvelatravésdo
Bluetooth
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Como emparelhar o dispositivo com o seu telemóvel
Para emparelhar o dispositivo com o seu telemóvel pela primeira
vez, siga os seguintes passos:
 Certifique-sedequeodispositivoeotelemóvelestãoauma
distânciamáximademetroumdooutro
 UnaocordãodepescoçoOdispositivoiráemitirumaluz
intermitentevermelhaeazul
 AtiveoBluetoothnoseutelemóvel
 Inicieoprocessodeemparelhamentodeacordocomasinstru-
çõesdomanualdeutilizadordoseutelemóvel
 Oseutelemóveliráapresentarumalistadedispositivos
BluetoothNalistaapresentadaselecioneCOM-DEX
Após o emparelhamento do dispositivo, este continuará empare-
lhado mesmo quando separar o cordão de pescoço.
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Chamadas recebidas – Ver ilustração 5
 AtenderachamadaPrimaobotãodepressão
 Faleparaomicrofoneenquantoodispositivoestiverpendu-
radonoseupescoço
 TerminarachamadaPrimaobotãodepressão
Nota: Também é possível atender e terminar chamadas através do
telemóvel. Tenhaematençãoquenalgunstelemóveispoderáter
deselecionaroCOM-DEXapartirdeumalistadedispositivos
Casocontrárioosomseráemitidoapartirdosaltifalantesdotele-
móvel
Chamadas efetuadas – Ver ilustração 5
 Marqueonúmeroapartirdotelemóvel
Nota: Também pode utilizar o dispositivo para transmitir som para
os seus aparelhos auditivos a partir de qualquer fonte sonora.
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Regulação do som durante a utilização
Ovolumeéreguladoatravésdotelemóvel
ParaexcluirossonsenvolventesprimaobotãoRoomOff(ver
ilustração)
Pode descarregar a aplicação COM-DEX a partir da App Store ou
do Google Play. Esta aplicação permite que utilize o seu telemóvel
como controlo remoto.
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MANUTENÇÃO
Limpe com um pano húmido. Não utilize produtos químicos.
Não o exponha a temperaturas extremas ou a altos níveis de
humidade.
Não o mergulhe em líquidos.
Quando o dispositivo não estiver a ser utilizado, mantenha-o
num local seco fora do alcance de crianças e animais de esti-
mação.
Nunca tente abrir ou reparar o dispositivo. Tal só pode ser efe-
tuado por pessoas autorizadas para o efeito.
INFORMAÇÕES SOBRE A EMISSÃO
Os níveis de emissão dos dispositivos Widex são várias vezes infe-
riores aos níveis transmitidos pelos telemóveis e outros equipa-
mentos de comunicação.
Para mais informações, nomeadamente relacionadas com pes-
soas portadoras de implantes médicos, descarregue o documento
"Informações sobre WidexLinkTM" em www.widex.com/widexlink
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RESOLUÇÃO DE PROBLEMAS
Problema Causa possível Solução
O dispositivo não
funciona
a) O dispositivo está
com a bateria fraca.
b) O telemóvel está
em modo silen-
cioso.
c) O aparelho auditivo
está com a pilha
fraca.
d) Está fora de
alcance.
a) Carregue a bateria
do dispositivo.
b) Mude para o modo
normal.
c) Mude a pilha do
aparelho auditivo.
d) O Bluetooth tem
um alcance até 10
m.
Sem som a) Não está ligado
através de Blue-
tooth.
a) Repita o processo
de emparelha-
mento.
Se os problemas persistirem, contacte o seu audiologista.
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ADVERTÊNCIAS
ADVERTÊNCIA
Não utilize o dispositivo em minas ou noutras áreas com gases explo-
sivos.
Quando o dispositivo se encontra ligado através do cabo micro USB a
equipamentos externos alimentados pela rede elétrica, tais como car-
regadores de bateria, computadores, fontes sonoras ou equipamentos
semelhantes, estes equipamentos devem estar em conformidade com
as normas de segurança IEC 60065, IEC 60950-1, IEC 60601-1 ou nor-
mas equivalentes.
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A Widex A/S declara, por este meio, que este COM-DEX está em
conformidade com os requisitos essenciais e outras disposições
relevantes da Diretiva 1999/5/CE.
PodeobterumacópiadaDeclaraçãodeConformidadeem
http://www.widex.com/doc
Os símbolos habitualmente utilizados pela Widex A/S na etiquetagem
de dispositivos médicos (etiquetas/IFU/etc.)
Símbolo Título/Descrição
Fabricante
O produto é produzido pelo fabricante cujo nome e mora-
da estão indicados ao lado do símbolo. Caso seja apropria-
do, pode tamm estar indicada a data de fabrico.
Data de fabrico
A data em que o produto foi fabricado.
Prazo de validade
A data após a qual o produto não deve ser utilizado.
Código do lote
O código do lote do produto (identificação do lote ou re-
messa).
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Os símbolos habitualmente utilizados pela Widex A/S na etiquetagem
de dispositivos médicos (etiquetas/IFU/etc.)
Símbolo Título/Descrição
Fabricante
O produto é produzido pelo fabricante cujo nome e mora-
da estão indicados ao lado do símbolo. Caso seja apropria-
do, pode tamm estar indicada a data de fabrico.
Data de fabrico
A data em que o produto foi fabricado.
Prazo de validade
A data após a qual o produto não deve ser utilizado.
Código do lote
O código do lote do produto (identificação do lote ou re-
messa).
SÍMBOLOS
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Símbolo Título/Descrição
Número de catálogo
O número de catálogo (item) do produto
Número de série
O número de série do produto.*
Proteja da luz solar.
O produto deve ser protegido de fontes de luz e/ou
O produto deve ser mantido longe do calor
Manter seco
O produto deve ser protegido da humidade e/ou
O produto deve ser protegido da chuva
Limite inferior de temperatura
A temperatura mínima a que um produto pode ser exposto
com segurança.
Símbolo Título/Descrição
Limite superior de temperatura
A temperatura máxima a que um produto pode ser expos-
to com segurança.
Limites de temperatura
A temperatura máxima e mínima a que um produto pode
ser exposto com segurança.
Consulte as instruções de utilização
As instruções de utilização contêm informão preventiva
importante (avisos/precauções) e devem ser lidas antes de
utilizar o produto.
Cuidado/Aviso
Textos marcados com um símbolo cuidado/aviso devem
ser lidos antes de utilizar o produto.
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Símbolo Título/Descrição
Número de catálogo
O número de catálogo (item) do produto
Número de série
O número de série do produto.*
Proteja da luz solar.
O produto deve ser protegido de fontes de luz e/ou
O produto deve ser mantido longe do calor
Manter seco
O produto deve ser protegido da humidade e/ou
O produto deve ser protegido da chuva
Limite inferior de temperatura
A temperatura mínima a que um produto pode ser exposto
com segurança.
Símbolo Título/Descrição
Limite superior de temperatura
A temperatura máxima a que um produto pode ser expos-
to com segurança.
Limites de temperatura
A temperatura máxima e mínima a que um produto pode
ser exposto com segurança.
Consulte as instruções de utilização
As instruções de utilização contêm informão preventiva
importante (avisos/precauções) e devem ser lidas antes de
utilizar o produto.
Cuidado/Aviso
Textos marcados com um símbolo cuidado/aviso devem
ser lidos antes de utilizar o produto.
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Símbolo Título/Descrição
Marca REEE
“Não eliminar no lixo geral”
Na altura de descartar o produto, este deve ser enviado
para um ponto de recolha assinalado como sendo de reci-
clagem e recuperação.
Marca CE
Este produto está em conformidade com os requisitos es-
tabelecidos nas diretrizes de Marcação CE Europeia.
Alerta
O produto vem identificado com a Diretiva ER&ETT
1999/5/CE, como sendo um produto de Classe 2 com algu-
mas restrições de uso em alguns estados membros da CE.
Símbolo Título/Descrição
Marca RCM
Este produto está em conformidade com os requerimen-
tos regulamentares de segurança elétrica, CEM e espetro
de rádio para produtos fornecidos ao mercado australiano
e neo-zelandês.
Interferência
Pode ocorrer alguma interferência eletromagnética na
proximidade do produto.
*O número de seis ou sete dígitos no produto é o número de série. Os
números de série nem sempre podem ser precedidos de
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Símbolo Título/Descrição
Marca REEE
“Não eliminar no lixo geral”
Na altura de descartar o produto, este deve ser enviado
para um ponto de recolha assinalado como sendo de reci-
clagem e recuperação.
Marca CE
Este produto está em conformidade com os requisitos es-
tabelecidos nas diretrizes de Marcação CE Europeia.
Alerta
O produto vem identificado com a Diretiva ER&ETT
1999/5/CE, como sendo um produto de Classe 2 com algu-
mas restrições de uso em alguns estados membros da CE.
Símbolo Título/Descrição
Marca RCM
Este produto está em conformidade com os requerimen-
tos regulamentares de segurança elétrica, CEM e espetro
de rádio para produtos fornecidos ao mercado australiano
e neo-zelandês.
Interferência
Pode ocorrer alguma interferência eletromagnética na
proximidade do produto.
*O número de seis ou sete dígitos no produto é o número de série. Os
números de série nem sempre podem ser precedidos de
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DESCRIZIONE DEL DISPOSITIVO - Vedere illustrazione 1
 Pulsante
 PulsanteRoomOff
 LED
 Microfono
 Cavettodaindossareintornoalcollo
 MicroUSB
Nota: vi preghiamo di leggere con molta attenzione il presente
libretto d’istruzioni, prima di utilizzare questo dispositivo.
Scopo del prodotto
Questo dispositivo è stato realizzato per migliorare la capacità
delle persone ipoacusiche nel comunicare con il telefono cellulare
e consente un utilizzo ed una gestione più agevoli degli apparec-
chi acustici, grazie ad un metodo di controllo tramite smartphone.
Nota: Questo dispositivo utilizza lo standard Bluetooth, comune
nei modelli di telefoni cellulari più nuovi.
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ACCESSORI – Vedere illustrazione 2
 CavoUSB
CARICAMENTO – Vedere illustrazione 3
 CollegareilcavoUSBtraildispositivoel’alimentatoreper
lacorrenteSiraccomandadiNONcollegaretraloroledue
partidelcavettodacollomentreildispositivoèinfasedi
caricamento
 Spiarossacaricamentoincorso
Spiaverdericaricacompletata
Duratadellabatteriaoreinstreaminggiorniinstandby
MODALITÀ DI UTILIZZO – Vedere illustrazione 4
 Collegareledueestremitàdelcavettoperilcollo
Ilcavettodacollofunzionaanchecomeinterruttoreonoff
perl’accensioneelospegnimentodeldispositivo
 Accoppiareildispositivoaltelefonocellularetramiteil
Bluetooth
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Come accoppiare il dispositivo al telefono cellulare
Per accoppiare il dispositivo al telefono cellulare per la prima
volta, seguire questi passi:
 Accertarsicheildispositivoeiltelefonositrovinoentro
metrodidistanzal’unodall’altro
 CollegareilcavettoperilcolloLaspialuminosarossaeblu
inizieràoraalampeggiare
 AttivareilBluetoothdelcellulare
 Quindiseguirelaproceduradiaccoppiamentosecondole
istruzionidelpropriotelefono
 Sulloschermodelvostrotelefonoappariràoral’elencodei
dispositiviBluetoothdisponibiliSelezionarelavoceCOM-
DEXdallalista
Una volta completata la procedura, l’accoppiamento resterà
valido anche quando si scollega il cavetto da collo.
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Telefonate in arrivo – Vedere illustrazione 5
 Rispondereallachiamatapremereilpulsante
 Quandosiindossaildispositivointornoalcolloparlare
dentroilmicrofono
 Terminarelatelefonatapremeredinuovoilpulsante
Nota: E’ possibile rispondere o terminare la telefonata anche
direttamente, tramite il telefono cellulare. Si fa notare che con
alcuni tipi di cellulari, potrebbe prima essere necessario sele-
zionare il COM-DEX da un elenco. Altrimenti il suono verrà tra-
smesso tramite l’altoparlante del telefono.
Telefonate in uscita – Vedere illustrazione 5
 Comporreilnumerodachiamaretramiteilcellulare
Nota: E’ possibile utilizzare questo dispositivo anche per trasmet-
tere agli apparecchi acustici il suono proveniente da qualsiasi
altra sorgete sonora esterna.
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Come regolare il suono durante l’uso
Ilvolumevaregolatodirettamentetramiteiltelefonocellulare
Pereliminaretemporaneamenteisuoniambientali
PremereiltastoRoomOff-Vedereillustrazione
La app COM-DEX può essere scaricata da App Store oppure da
Google Play. Questa app vi consente di utilizzare il telefono cellu-
lare come fosse un telecomando.
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CURA E MANUTENZIONE
Pulire il dispositivo con un panno morbido e appena inumidito.
Non usare detergenti, né altre sostanze chimiche.
Non esporlo mai a temperature estreme o a forte umidità.
Non immergerlo in acqua o altri liquidi.
Quando non lo si usa, conservarlo in un luogo fresco e asciutto,
fuori dalla portata di bambini ed animali.
Non tentare mai di aprire o di riparare da soli questo disposi-
tivo. Tali operazioni devono essere eseguite esclusivamente da
personale specializzato.
INFORMAZIONI SULLE EMISSIONI
I livelli di emissioni elettromagnetiche dei dispositivi Widex sono
parecchie volte più bassi di quelli emessi dai telefoni cellulari e
dagli altri apparecchi per la comunicazione.
Per ulteriori informazioni, soprattutto riguardo ai pazienti con
impianti medici, si prega di scaricare il documento: "Informazioni
su WidexLinkTM" da questo link: www.widex.com/widexlink
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SOLUZIONI RAPIDE AI PROBLEMI
Problema Possibile causa Soluzione
Il dispositivo non
funziona
a) Batteria scarica
b) Il cellulare è impo-
stato in modalità
silenziosa
c) Batteria dell’appa-
recchio acustico
quasi esaurita
d) Fuori campo opera-
tivo
a) Caricare la batteria
del dispositivo
b) Impostarlo in
modalità normale
c) Sostituire la batte-
ria dell’apparecchio
acustico
d) Il campo operativo
del Bluetooth
arriva fino a 10 mt
mtNessun suono a) Non connesso tra-
mite Bluetooth
a) Ripetere la proce-
dura di accoppia-
mento
Se il problema persiste, contattare il proprio Audioprotesista.
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AVVERTENZE IMPORTANTI
ATTENZIONE
Questo dispositivo non è omologato per l’utilizzo nelle miniere o in altre
zone con gas esplosivi e dunque, in simili circostanze, non deve essere
usato.
Quando si collega il dispositivo tramite il cavo micro USB ad apparec-
chiature esterne alimentate da corrente elettrica quali caricatore, com-
puter, riproduttori audio o simili, è necessario accertarsi che tali appa-
recchiature siano conformi alle direttive IEC 60065, IEC 60950, IEC
60601-1 ed alle norme di sicurezza equivalenti.
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Con la presente Widex A/S dichiara che il presente dispositivo
COM-DEX è conforme ai requisiti essenziali ed alle altre disposi-
zioni pertinenti stabilite dalla Direttiva 1999/5/CE.
UnacopiadellaDichiarazionediConformità
puòessereconsultatasu
http://www.widex.com/doc
Simboli utilizzati solitamente da Widex A/S per l’etichettatura dei suoi
dispositivi medici (etichette, IFU, informazioni di prodotto ecc.)
Simbolo Titolo/Descrizione
Produttore
Il prodotto è stato fabbricato dalla casa produttrice, il cui
nome ed indirizzo appaiono accanto a questo simbolo.
Quando necessario, viene riportata anche la data di fab-
bricazione.
Data di fabbricazione
La data in cui il prodotto è stato fabbricato.
Scadenza
La data oltre la quale non bisogna più utilizzare il prodotto.
Codice del lotto
Il codice che identifica il lotto del prodotto (identificazione
lotto).
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Simboli utilizzati solitamente da Widex A/S per l’etichettatura dei suoi
dispositivi medici (etichette, IFU, informazioni di prodotto ecc.)
Simbolo Titolo/Descrizione
Produttore
Il prodotto è stato fabbricato dalla casa produttrice, il cui
nome ed indirizzo appaiono accanto a questo simbolo.
Quando necessario, viene riportata anche la data di fab-
bricazione.
Data di fabbricazione
La data in cui il prodotto è stato fabbricato.
Scadenza
La data oltre la quale non bisogna più utilizzare il prodotto.
Codice del lotto
Il codice che identifica il lotto del prodotto (identificazione
lotto).
SIMBOLI
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Simbolo Titolo/Descrizione
Codice catalogo
Il codice numerico che identifica il prodotto all'interno del
catalogo.
Numero seriale
Il numero di serie del prodotto.*
Tenere al riparo dalla luce del sole
Il prodotto deve essere protetto dalle sorgenti luminose
e/o deve essere mantenuto al riparo dal calore.
Tenere all'asciutto
Il prodotto deve essere protetto dall'umidità e/o deve es-
sere tenuto al riparo dalla pioggia.
Limite minimo di temperatura
Questa è la temperatura minima che il prodotto è in grado
di sopportare senza rischi.
Simbolo Titolo/Descrizione
Limite massimo di temperatura
Questa è la temperatura massima che il prodotto è in gra-
do di sopportare senza rischi.
Limiti di temperatura
Questi sono i limiti di temperatura massima e minima che il
prodotto è in grado di sopportare senza rischi.
Consultare le istruzioni per l'uso
Le istruzioni per l'uso contengono informazioni importanti
per gli utenti (avvertenze e precauzioni) e devono essere
lette con attenzione prima di utilizzare il prodotto.
Precauzioni/Avvertenze
Il testo contrassegnato da questo simbolo contiene delle
avvertenze e precauzioni importanti e deve essere letto
con attenzione prima di utilizzare il prodotto.
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Simbolo Titolo/Descrizione
Limite massimo di temperatura
Questa è la temperatura massima che il prodotto è in gra-
do di sopportare senza rischi.
Limiti di temperatura
Questi sono i limiti di temperatura massima e minima che il
prodotto è in grado di sopportare senza rischi.
Consultare le istruzioni per l'uso
Le istruzioni per l'uso contengono informazioni importanti
per gli utenti (avvertenze e precauzioni) e devono essere
lette con attenzione prima di utilizzare il prodotto.
Precauzioni/Avvertenze
Il testo contrassegnato da questo simbolo contiene delle
avvertenze e precauzioni importanti e deve essere letto
con attenzione prima di utilizzare il prodotto.
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Simbolo Titolo/Descrizione
Marchio RAEE
Questo prodotto elettronico va smaltito come rifiuto
speciale, non generico.
Quando si decide di eliminare il prodotto è necessario in-
viarlo agli appositi punti di raccolta, per il riciclo ed il recu-
pero dei materiali.
Marchio CE
Il prodotto è conforme alle prescrizioni imposte dalle Di-
rettive Europee CE.
Avviso
Il prodotto è identificato dalla Direttiva 1999/5/CE R&TTE
come apparecchiatura di Classe 2, avente delle limitazioni
per l'utilizzo in alcuni Stati membri CE.
Simbolo Titolo/Descrizione
Marchio RCM
Questo prodotto è conforme alle normative riguardanti la
sicurezza elettrica, le emissioni elettromagnetiche e radio
in vigore in Australia e Nuova Zelanda.
Interferenza
In prossimità del prodotto potrebbero verificarsi delle in-
terferenze elettromagnetiche.
*Il numero a sei o sette cifre presente sul prodotto è il numero di serie. I
numeri seriali non sempre sono preceduti da
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Simbolo Titolo/Descrizione
Marchio RAEE
Questo prodotto elettronico va smaltito come rifiuto
speciale, non generico.
Quando si decide di eliminare il prodotto è necessario in-
viarlo agli appositi punti di raccolta, per il riciclo ed il recu-
pero dei materiali.
Marchio CE
Il prodotto è conforme alle prescrizioni imposte dalle Di-
rettive Europee CE.
Avviso
Il prodotto è identificato dalla Direttiva 1999/5/CE R&TTE
come apparecchiatura di Classe 2, avente delle limitazioni
per l'utilizzo in alcuni Stati membri CE.
Simbolo Titolo/Descrizione
Marchio RCM
Questo prodotto è conforme alle normative riguardanti la
sicurezza elettrica, le emissioni elettromagnetiche e radio
in vigore in Australia e Nuova Zelanda.
Interferenza
In prossimità del prodotto potrebbero verificarsi delle in-
terferenze elettromagnetiche.
*Il numero a sei o sette cifre presente sul prodotto è il numero di serie. I
numeri seriali non sempre sono preceduti da
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機器の概要– 図参照
1.1 プュボ
1.2補聴器フボ
1.3 LED
1. 4  イク
1 . 5 ッ ク ープ
1.6 マロUSB
器をご使用にな前にの取扱説書をお読
みくだ
使用目
補聴器を使携帯電話での通話やす
スマートフォよりすること
注 意:多 くの ストフ ォン さ れ て い
Bluetoothルース)機能を使ます
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付属品 – 図参照
2.1 USBケ
充電方法 – 図参照
3.1 USBケ本器電源接続充電す
際、ルーの接続部を推奨
3 . 2  赤 点 灯:充 電 中 点 灯:充 電 完 了
使時8時時8
使用方法 – 図参照
4.1 ネックを接続します
 ネプはオンチを兼います
4.2本器Bluetoothペ
す。
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89
リン
、以 す :
1.  本 器マートフォ距 離 が1m 以 内ようにし
す。
2.ックを接続します色と青色の点
す。
3.のBluetoothを有効に
4.ンの取に従ングを開
す。
5.表示BluetoothデらCOM-
DEXを選択
ペアリングされると、ック断してもペア
リンは 有 効 です。
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電話の着– 図参照
5.1 通話開始:プ
5.2を首からぶ下げ蔵マに話します
5.3通話終:プ
注意通話の開始終了は、の操作で
ては力可
リストか らC O M - D E X選 択 する 必 要 が あ
。C O M - D E X ス マ ー トフ ォ
スピーカ力され
電話の – 図参照
5 . 4 トフ ォン イ アル しま す
参 考:使って、々なを補
器 へ 伝 送 すが で きす。
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91
使用中音量調節
ス マトフ上 で 量 を 調 節 しま す
マ イ ボ タ す 。–
図 1 .参
COM-DEXアプをAppStoreやGooglePlay
きまのアリを使うことスマート
ンから補聴器をン操できます
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手入
• お手れのいたやわかい拭いださ
決し水やなどを使用しでくさい
• 、高 湿 て く
• やその他の液体にい。
• 使用しないはケーに保管し、子さまペットの
手の届かない涼し湿度の低い所で保管し
ださい
• 、ま う と し
れた人によのみ行われます
電 磁 放 射 にして
、ス ト フ ォ ン
他の通に比べて格段に低ています
込 み 型医 療 機 器をご 使 用する場 合 の
報“Information on WidexLinkTM”(英文)
は、下記能です
“http://www.widex.com/widexlink
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93
るとき
問題 えら解決策
作しなa)池容量の低
b)
レ ン ト(
)モ ー ド に
って い
c)補聴器の電池
量の低下
d)通信範囲外
a)充電ます
b)通常モ
設 定しま
c)補聴器の電池
しま
d)通信範囲内に
けます
(Bluetooth
囲10
m)
聞こえなa)Bluetooth
れて
a)再度
しま
それでも問善しない合は店にご相談く
ださい
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するこ
 重要
•器をガスのある場所で使用しないでくださ
い。
•ソコンなどの源コンセントにつな
にマクロUSBケーブル通しを接する場
その外部機器が国規格IEC 60065、IEC 60950-1
IEC60601-1または同等の安準に準拠しいる
が 求ら れす。
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Widex A/S 社はCOM-DEX が指令1995/5/EC
基本的要事項び関連事項適合宣言
す。
言のーは記にてご覧いただけます
http://wwwwidexcom/doc
株式会社が製造販売す管理医療機器の表示
(ラベル/書/)に通して使される
記号 名称/意味
製造元
製品の者名、所の所在
年月も記されるます
年月
された年月
使年月
品の使可能
ット 番 号
製品の番号 (製造時の生産単を特定
る番号)
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株式会社が製造販売す管理医療機器の表示
(ラベル/書/)に通して使される
記号 名称/意味
製造元
製品の者名、所の所在
年月も記されるます
年月
された年月
使年月
品の使可能
ット 番 号
製品の番号 (製造時の生産単を特定
る番号)
使用される記
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97
記号 名称/意味
カタロ
製品のグ(品目)番号
シリアル
製品のル(製造)番号*
射 日 、熱 遮 蔽
、直 て く
い。
水ぬれ禁止
湿護り、らさいでくださ
い。
の下
安全最低温度
記号 名称/意味
保管温度の上限
品 を安 全保 管きる高 温 度
保管温度限界
製品を安全に保管る最び最低温
明書を参照
取 扱 説明 書安 全関 する重 要お 知らせ
(/) が含まれていますのでのご
使必ずみください
重要/意
/ 意 の 号 を 伴 う 項 は 、製 品 の ご
使必ずみください
WEEEマーク
一 般 廃 棄 物で はりま
製品の廃棄は、自治体によれた分別
リサイ従っください
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記号 名称/意味
カタロ
製品のグ(品目)番号
シリアル
製品のル(製造)番号*
射 日 、熱 遮 蔽
、直 て く
い。
水ぬれ禁止
湿護り、らさいでくださ
い。
の下
安全最低温度
記号 名称/意味
保管温度の上限
品 を安 全保 管きる高 温 度
保管温度限界
製品を安全に保管る最び最低温
明書を参照
取 扱 説明 書安 全関 する重 要お 知らせ
(/) が含まれていますのでのご
使必ずみください
重要/意
/ 意 の 号 を 伴 う 項 は 、製 品 の ご
使必ずみください
WEEEマーク
一 般 廃 棄 物で はりま
製品の廃棄は、自治体によれた分別
リサイ従っください
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99
記号 名称/意味
CEマー
品はCEマークに関る欧州指令によて定
ら れ た 件 に 適 合 してい ます。
注意
製品は、R&TTE指令(無線機器、電気通信
末機器に関す欧州指一部CE加
盟 国 で の 使 用 に 制 限 を 伴 うラス 器 として
分 類 す。
RCMマ
、オ ア と ニ ュ
される製品に対る、性お
E M C・無 クト 規 制 要 件 に 準
す。
記号 名称/意味
電 磁 波よる干 渉
品 の 近 くで は 電 磁 波 に よる 干 渉 起 き
能 性 が あま す。
* 製 品 に記 載 さて いる6 桁は7桁 の 数 字 は 番 号
よ っ て 、シ され
い 場 合 もす。
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99
記号 名称/意味
CEマー
品はCEマークに関る欧州指令によて定
ら れ た 件 に 適 合 してい ます。
注意
製品は、R&TTE指令(無線機器、電気通信
末機器に関す欧州指一部CE加
盟 国 で の 使 用 に 制 限 を 伴 うラス 器 として
分 類 す。
RCMマ
、オ ア と ニ ュ
される製品に対る、性お
E M C・無 クト 規 制 要 件 に 準
す。
記号 名称/意味
電 磁 波よる干 渉
品 の 近 くで は 電 磁 波 に よる 干 渉 起 き
能 性 が あま す。
* 製 品 に 載 さて いま たは7桁 の 数 字 はリア 番 号
よ っ て 、シ され
い 場 合 もす。
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100
101
DESCRIPTION OF DEVICE – See illustration 1
 Pushbutton
 RoomOffbutton
 LED
 Microphone
 Neckloop
 MicroUSB
Note: Read these instructions carefully before you start using the
device.
Intended use:
This device is intended to improve your ability to use Bluetooth
enabled mobile phone connections with your hearing aid(s). The
aid(s) can further be manipulated by the controls on the mobile
phone.
Note: The device uses Bluetooth standard which is common in
newer mobile phones.
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100
101
ACCESSORIES – See illustration 2
 USBcable
CHARGING – See illustration 3
 ConnectUSBcablebetweenthedeviceandanypower
supplyWerecommendthatthetwonecklooppartsare
notjoinedwhilechargingthedevice
 Redlightcharginggreenlightfullycharged
Batterylifehoursstreamingdaysstandby
HOW TO USE – See illustration 4
 JointhetwonecklooppartsTheneckloopfunctionsas
anonoffswitch
 PairthedevicetoyourmobilephoneusingBluetooth
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102
103
How to pair the device with your mobile phone
To pair your device with your mobile phone for the first time, fol-
low these steps:
 Makesurethatthedeviceandmobilephonearewithinft
rangeofeachother
ConnecttheneckloopThedevicewillblinkredandblue
 ActivateBluetoothonyourmobilephone
 Startthepairingprocessaccordingtotheinstructionsinyour
mobilephonesuserguide
 YourmobilephonewillshowalistofBluetoothdevices
SelectCOM-DEXfromthelist
Once you have paired the device, it will remain paired even when
you disconnect the neck loop.
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103
Incoming calls – See illustration 5
 AnswercallPresspushbutton
 Speakintomicrophonewhiledeviceishangingaround
yourneck
 EndcallPresspushbutton
Note: Answering and ending calls is also possible on the mobile
phone. Notethat on some mobile phones youmay need to
selecttheCOM-DEXfromalistofdevicesOtherwisethesound
willbetransmittedthroughthemobilephonesspeakers
Outgoing calls – See illustration 5
 Dialfrommobilephone
Note: You can also use the device to stream sound from any
Bluetooth enabled sound source to your hearing aids.
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105
Sound adjustment during use
Volumeisadjustedonthemobilephone
ToshutoutsurroundingsoundspressRoomOffbutton–See
illustration
You can download the COM-DEX app from the App Store or
Google Play. This app allows you to use your mobile phone as a
remote control.
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105
MAINTENANCE
Clean with a damp cloth. Do not use chemicals.
Do not expose to extreme temperatures or high humidity.
Do not immerse in liquids.
When the device is not in use keep it in a dry location out of
reach of children and pets.
Never try to open or repair the device yourself. This may only
be done by authorized personnel.
INFORMATION ABOUT EMISSION
Emission levels from Widex devices are several times lower than
the levels transmitted by mobile phones and other communica-
tions equipment.
For further information, especially regarding patients with
medical implants, download the document: “Information on
WidexLinkTM” at www.widex.com/widexlink
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106
107
TROUBLESHOOTING
Problem Possible cause Solution
The device does not
work
a) Device battery low
b) The mobile phone is
set to silent mode
c) Hearing aid battery
low
d) Out af range
a) Charge device bat-
tery
b) Set to normal
mode
c) Change hearing aid
battery
d) Bluetooth has a
range up to 30 ft.
No sound a) Not connected via
Bluetooth
a) Repeat the pairing
process
If the problems persist, contact your hearing care professional.
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106
107
WARNINGS
WARNING
Do not use the device in mines or other areas with explosive gases.
When the device is connected via micro USB cable to external mains-
operated equipment such as a charger, PC, audio source or similar, this
equipment must comply with IEC 60065, IEC 60950-1, IEC 60601-1 or
equivalent safety standards.
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108
109
REGULATORY INFORMATION
The following Table summarizes the technical details of the Bluetooth
and WidexLink technology as it is implemented in the COM-DEX.
Unit COM-DEX Hearing aid
Type W-link Bluetooth* W-link
Antenna type Inductive Loop
antenna
Embedded
ceramic
antenna
Inductive
antenna
Antenna
dimensions
L: 70 cm NA Ø1 .8 mm
L – 4 .85mm
Modulation FSK FHSS/GFSK,
π/4 DPSK,
8DPSK
FSK
lch
D:20141117083232+01’00’17-11-2014 08:32:32
------------------------------------------
-- M-DEX
Magnetic Field
Strength
-26dBμA/m at
10m distance
NA -54dBμA/m at
10m distance
Output power 1.2 nW EIRP**
-59 dBm
2.5 mW EIRP
+4dBm
29pW EIRP**
-75 dBm
Range <1m remote
unit to hearing
aid
<10m between
COM-DEX and
Bluetooth
device
<1m remote unit
to hearing aid
<30cm be-
tween hearing
aids
Center fre-
quency
10.6MHz 2 .45GHz ISM 10.6MHz
Channels Single channel
radio
80 channels Single channel
radio
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108
109
REGULATORY INFORMATION
The following Table summarizes the technical details of the Bluetooth
and WidexLink technology as it is implemented in the COM-DEX.
Unit COM-DEX Hearing aid
Type W-link Bluetooth* W-link
Antenna type Inductive Loop
antenna
Embedded
ceramic
antenna
Inductive
antenna
Antenna
dimensions
L: 70 cm NA Ø1 .8 mm
L – 4 .85mm
Modulation FSK FHSS/GFSK,
π/4 DPSK,
8DPSK
FSK
lch
D:20141117083232+01’00’17-11-2014 08:32:32
------------------------------------------
-- M-DEX
Magnetic Field
Strength
-26dBμA/m at
10m distance
NA -54dBμA/m at
10m distance
Output power 1.2 nW EIRP**
-59 dBm
2.5 mW EIRP
+4dBm
29pW EIRP**
-75 dBm
Range <1m remote
unit to hearing
aid
<10m between
COM-DEX and
Bluetooth
device
<1m remote unit
to hearing aid
<30cm be-
tween hearing
aids
Center fre-
quency
10.6MHz 2 .45GHz ISM 10.6MHz
Channels Single channel
radio
80 channels Single channel
radio
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110
111
Bandwidth 660kHz
(-15dB)
1MHz 660kHz (-15dB)
Duty Cycle *** Up to 100 % < 100 % < 5 %
Data rate 212kbit/s raw
channel capac-
ity
3 Mbit/s 212kbit/s raw
channel capac-
ity
Data flow Simplex or
semiduplex
Time division
duplex (TDD)
Simplex or
semiduplex
Protocol Random
access
– no collision
avoidance
Packet based
protocol, time
divided
Random access
– no collision
avoidance
* Bluetooth specification v 4.1 + EDR/LE published by the Bluetooth
Special Interest Group (SIG)
** EIRP = Equivalent isotropically radiated power
*** Duty Cycle averaged over 1 hour of operation
Cablesandtransducers
The COM-DEX is using a micro USB cable for charging.
Guidanceandmanufacturer’sdeclaration
Electromagneticemissions
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Emissions
test
Compliance Electromagnetic environment
- guidance
RF emissions
CISPR 11
Group 1 The COM-DEX 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.
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110
111
Bandwidth 660kHz
(-15dB)
1MHz 660kHz (-15dB)
Duty Cycle *** Up to 100 % < 100 % < 5 %
Data rate 212kbit/s raw
channel capac-
ity
3 Mbit/s 212kbit/s raw
channel capac-
ity
Data flow Simplex or
semiduplex
Time division
duplex (TDD)
Simplex or
semiduplex
Protocol Random
access
– no collision
avoidance
Packet based
protocol, time
divided
Random access
– no collision
avoidance
* Bluetooth specification v 4.1 + EDR/LE published by the Bluetooth
Special Interest Group (SIG)
** EIRP = Equivalent isotropically radiated power
*** Duty Cycle averaged over 1 hour of operation
Cablesandtransducers
The COM-DEX is using a micro USB cable for charging.
Guidanceandmanufacturer’sdeclaration
Electromagneticemissions
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Emissions
test
Compliance Electromagnetic environment
- guidance
RF emissions
CISPR 11
Group 1 The COM-DEX 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.
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112
113
RF emissions
CISPR 11
Class B The COM-DEX 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 pur-
poses.
Harmonic
emissions
IEC
61000-3-2
Not
applicable *)
Voltage fluc-
tua-tions/
flicker emis-
sions
IEC
61000-3-3
Not
applicable *)
*) Battery powered equipment
Electromagneticimmunity
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Immunity Test IEC 60601
Test level
Compliance
level
Electromagnetic
environment
– guidance
Electro-static
discharge
(ESD)
IEC
61000-4-2
± 6 kV con-
tact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humid-
ity should be at
least 30 %.
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112
113
RF emissions
CISPR 11
Class B The COM-DEX 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 pur-
poses.
Harmonic
emissions
IEC
61000-3-2
Not
applicable *)
Voltage fluc-
tua-tions/
flicker emis-
sions
IEC
61000-3-3
Not
applicable *)
*) Battery powered equipment
Electromagneticimmunity
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Immunity Test IEC 60601
Test level
Compliance
level
Electromagnetic
environment
– guidance
Electro-static
discharge
(ESD)
IEC
61000-4-2
± 6 kV con-
tact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humid-
ity should be at
least 30 %.
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114
115
Electrical fast
transients/
burst
IEC
61000-4-4
± 2 kV for
power line
supplies
± 1 kV for
input/output
lines
Not
applicable *)
Not applicable
*)
Not
applicable *)
Surge
IEC
61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Not
applicable *)
Not
applicable *)
Not
applicable *)
Voltage dips,
short inter-rup-
tions and volt-
age variations
on power sup-
ply input lines
IEC
61000-4-11
<5 % UT
(>95 % dip
in UT
) for
0.5 cycle
40 % UT
(60 % dip
in UT
) for 5
cycles
70 % UT
(30 % dip
in UT
) for 25
cycles
<5 % UT
(>95 % dip
in UT
) for 5 s
Not
applicable *)
Not
applicable *)
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114
115
Electrical fast
transients/
burst
IEC
61000-4-4
± 2 kV for
power line
supplies
± 1 kV for
input/output
lines
Not
applicable *)
Not applicable
*)
Not
applicable *)
Surge
IEC
61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Not
applicable *)
Not
applicable *)
Not
applicable *)
Voltage dips,
short inter-rup-
tions and volt-
age variations
on power sup-
ply input lines
IEC
61000-4-11
<5 % UT
(>95 % dip
in UT
) for
0.5 cycle
40 % UT
(60 % dip
in UT
) for 5
cycles
70 % UT
(30 % dip
in UT
) for 25
cycles
<5 % UT
(>95 % dip
in UT
) for 5 s
Not
applicable *)
Not
applicable *)
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116
117
Power fre-
quency (50/60
Hz) magnetic
field
IEC
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 commercial
or hospital environ-
ment
NOTE UT is the a.c. mains voltage prior to the application of the test
level.
*) Battery powered equipment
Electromagneticimmunity–cont
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Immunity
Test
IEC 60601
Test level
Compli-
ance level
Electromagnetic
environment
– guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the COM-DEX,
including cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the trans-
mitter.
9 514 0313 080_booklet.indb 116 21-08-2015 14:03:48
116
117
Power fre-
quency (50/60
Hz) magnetic
field
IEC
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 commercial
or hospital environ-
ment
NOTE UT is the a.c. mains voltage prior to the application of the test
level.
*) Battery powered equipment
Electromagneticimmunity–cont
The COM-DEX is intended for use in the electromagnetic environment
specified below. The customer or the user of a COM-DEX should assure
that it is used in such an environment.
Immunity
Test
IEC 60601
Test level
Compli-
ance level
Electromagnetic
environment
– guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the COM-DEX,
including cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the trans-
mitter.
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118
119
Conducted
RF
IEC
61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Recommended separation
distance
d = 1.2 P
Radiated
RF
IEC
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 transmitter
manufacturer and d is the
recommended separation
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 compliance
level in each frequency
range b.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
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118
119
Conducted
RF
IEC
61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Recommended separation
distance
d = 1.2 P
Radiated
RF
IEC
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 transmitter
manufacturer and d is the
recommended separation
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 compliance
level in each frequency
range b.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
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120
121
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromag-
netic propagation is affected by absorption and reflection from struc-
tures, 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 pre-
dicted theoretically with accuracy. To assess the electromagnetic envi-
ronment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in
which the COM-DEX is used exceeds the applicable RF compliance level
above, the COM-DEX should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be neces-
sary, such as re-orienting or re-locating the COM-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 COM-DEX.
The COM-DEX is intended for use in the electromagnetic environment in
which RF disturbances are controlled. The customer or the user of the
COM-DEX can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the COM-DEX as recommended below,
according to the maximum output power of the communications equip-
ment.
Rated maximum
output power of
transmitter
W
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
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120
121
Recommended separation distances
Recommended separation distances between portable and mobile RF
communication equipment and the COM-DEX.
The COM-DEX is intended for use in the electromagnetic environment in
which RF disturbances are controlled. The customer or the user of the
COM-DEX can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the COM-DEX as recommended below,
according to the maximum output power of the communications equip-
ment.
Rated maximum
output power of
transmitter
W
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
9 514 0313 080_booklet.indb 121 21-08-2015 14:03:49
122
123
11.2 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 manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromag-
netic propagation is affected by absorption and reflection from struc-
tures, objects and people.
This COM-DEX may be interfered with by other equipment even if that
other equipment complies with CISPR emission requirements.
EMCEMICompliance
The COM-DEX complies with the following EMC/EMI standards:
Standard Test type Note
47 CFR Part
15, subpart C
RF emissions USA Federal Communications Commis-
sion (FCC) requirements to intentional
radiators.
EN 300
330-2 V1.6.1
RF emissions
incl. Spurious
emission
EMC and radio spectrum matters for
Short Range Devices in the frequency
range 9 kHz – 25 MHz
EN 300 328
V1.9.1
RF emissions
incl. Spurious
emission
EMC and radio spectrum matters for
data transmission systems in the 2.4
GHz ISM band and using wide band
modulation techniques
IEC 60601-1-
2:2007
EMC emission
Immunity, RF
and ESD
Medical electrical equipment.
General requirements for basic safety
and essential performance.
Electromagnetic compatibility.
9 514 0313 080_booklet.indb 122 21-08-2015 14:03:49
122
123
11.2 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 manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromag-
netic propagation is affected by absorption and reflection from struc-
tures, objects and people.
This COM-DEX may be interfered with by other equipment even if that
other equipment complies with CISPR emission requirements.
EMCEMICompliance
The COM-DEX complies with the following EMC/EMI standards:
Standard Test type Note
47 CFR Part
15, subpart C
RF emissions USA Federal Communications Commis-
sion (FCC) requirements to intentional
radiators.
EN 300
330-2 V1.6.1
RF emissions
incl. Spurious
emission
EMC and radio spectrum matters for
Short Range Devices in the frequency
range 9 kHz – 25 MHz
EN 300 328
V1.9.1
RF emissions
incl. Spurious
emission
EMC and radio spectrum matters for
data transmission systems in the 2.4
GHz ISM band and using wide band
modulation techniques
IEC 60601-1-
2:2007
EMC emission
Immunity, RF
and ESD
Medical electrical equipment.
General requirements for basic safety
and essential performance.
Electromagnetic compatibility.
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125
EN 301 489-3
V1.6.1
Immunity, RF
and ESD
Standard for Low Power Transmitters in
the frequency range
9 kHz – 40 GHz
EN 301
489-17 V2.2.1
Immunity, RF
and ESD
Standard for Broadband Data Trans-
mission Systems in the frequency
range 9 kHz – 40 GHz
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125
Hereby, Widex A/S declares that this COM-DEX is in compliance
with the essential requirements and other relevant provisions of
Directive 1999/5/EC.
AcopyoftheDeclarationofConformitycanbefoundat
http://www.widex.com/doc
EN 301 489-3
V1.6.1
Immunity, RF
and ESD
Standard for Low Power Transmitters in
the frequency range
9 kHz – 40 GHz
EN 301
489-17 V2.2.1
Immunity, RF
and ESD
Standard for Broadband Data Trans-
mission Systems in the frequency
range 9 kHz – 40 GHz
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Symbols commonly used by Widex A/S in medical device labelling
(labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose
name and address are stated next to the symbol. If ap-
propriate, the date of manufacture may also be stated.
Date of manufacture
The date when the product was manufactured.
Use-by date
The date after which the product is not to be used.
Batch code
The product’s batch code (lot or batch identification).
SYMBOLS
Symbol Title/Description
Catalog number
The product’s catalog (item) number.
Serial number
The products serial number.*
Keep away from sunlight
This product must be protected from light source and
must be kept away from heat.
Keep dry
The product must be protected from moisture and/or
The product must be kept away from rain.
Lower limit of temperature
The lowest temperature to which the product can be
safely exposed.
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127
Symbols commonly used by Widex A/S in medical device labelling
(labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose
name and address are stated next to the symbol. If ap-
propriate, the date of manufacture may also be stated.
Date of manufacture
The date when the product was manufactured.
Use-by date
The date after which the product is not to be used.
Batch code
The product’s batch code (lot or batch identification).
Symbol Title/Description
Catalog number
The product’s catalog (item) number.
Serial number
The products serial number.*
Keep away from sunlight
This product must be protected from light source and
must be kept away from heat.
Keep dry
The product must be protected from moisture and/or
The product must be kept away from rain.
Lower limit of temperature
The lowest temperature to which the product can be
safely exposed.
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129
Symbol Title/Description
Upper limit of temperature
The highest temperature to which the product can be
safely exposed.
Temperature limits
The highest and lowest temperatures to which the prod-
uct can be safely exposed.
Consult instructions for use
The user instructions contain important cautionary infor-
mation (warnings/precautions) and must be read before
using the product.
Caution/Warning
Text marked with a caution/warning symbol must be read
before using the product.
Symbol Title/Description
WEEE mark
“Not for general waste”
When the product is to be discarded, it must be sent to a
designated collection point for recycling and recovery.
CE mark
The product is in conformity with the requirements set
out in European CE marking directives.
Alert
The product is identified by R&TTE Directive 1999/5/EC as
an equipment Class 2 product with some restrictions on
use in some CE member states.
RCM mark
The product complies with EMC and radio spectrum regu-
latory requirements for products supplied to the
Australian or New Zealand market.
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129
Symbol Title/Description
Upper limit of temperature
The highest temperature to which the product can be
safely exposed.
Temperature limits
The highest and lowest temperatures to which the prod-
uct can be safely exposed.
Consult instructions for use
The user instructions contain important cautionary infor-
mation (warnings/precautions) and must be read before
using the product.
Caution/Warning
Text marked with a caution/warning symbol must be read
before using the product.
Symbol Title/Description
WEEE mark
“Not for general waste”
When the product is to be discarded, it must be sent to a
designated collection point for recycling and recovery.
CE mark
The product is in conformity with the requirements set
out in European CE marking directives.
Alert
The product is identified by R&TTE Directive 1999/5/EC as
an equipment Class 2 product with some restrictions on
use in some CE member states.
RCM mark
The product complies with EMC and radio spectrum regu-
latory requirements for products supplied to the
Australian or New Zealand market.
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Symbol Title/Description
Interference
Electromagnetic interference may occur in the vicinity of
the product.
*The six-or seven-digit number on the product is the serial number.
Serial numbers may not always be preceded by
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PB
131
FCC AND IC STATEMENTS
FCC ID: TTY-CMDEX
IC: 5676B-CMDEX
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 interfer-
ence 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 communica-
tions. 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
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133
equipment off and on, the user is encouraged to try to correct the interfer-
ence by one or more of the following measures:
— 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 oper-
ate 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 radi-
ated power (e.i.r.p.) is not more than that necessary for successful com-
munication.
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This device complies with Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following two conditions:
(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 émet-
teur radio peut fonctionner avec une antenne d’un type et d’un gain maxi-
mal (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 dIndustrie 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 den compromettre le fonc-
tionnement.
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