USER MANUAL | GUIDE D’UTILISATION Notice TensioSmart... · USER MANUAL | GUIDE D’UTILISATION NL...
Transcript of USER MANUAL | GUIDE D’UTILISATION Notice TensioSmart... · USER MANUAL | GUIDE D’UTILISATION NL...
www.terraillon.com
USER MANUAL | GUIDE D’UTILISATIONNL Handleiding|IT Manuale di istruzion|ES Manual de instrucciones
DE Bedienungsanleitung|PT Manual de instruções
iPhone is registered trademark of Apple Inc.Android is a trademark of Google Inc.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
Other trademarks and trade names are those of their respective owners.
Made for / Compatibilité
iPhone® 4S & +iPod® Touch 5th generation
iPad® 3 & + iPad® Mini & +Android 4.4 & +Bluetooth Smart 4.0 / Bluetooth Smart Ready
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EN TERRAILLON CONNECTED BLOOD PRESSURE MONITOR INSTRUCTION MANUAL ............................................................................ 4
FR TENSIOMÈTRE CONNECTÉE TERRAILLON NOTICE D’UTILISATION ............................................................................. 8
NL TERRAILLON BLOEDDRUKMETER HANDLEIDING ........................................................................................ 12
IT SFIGMOMANOMETRO TERRAILLON MANUALE DI ISTRUZIONI ........................................................................ 16
ES TENSIÓMETRO TERRAILLON MANUAL DE INSTRUCCIONES ............................................................... 20
DE BLUTDRUCKMESSGERÄT TERRAILLON BEDIENUNGSANLEITUNG ....................................................................... 24
PT MONITOR DE PRESSÃO SANGUINEA TERRAILLON MANUAL DE INSTRUÇÕES ..................................................................... 28
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FIND MORE INFORMATION ON
http://www.terraillon.com
Thank you very much for selecting the Terraillon Arm Blood Pressure Monitor TENSIOSMART.
This unit allows you to monitor your blood pressure. This device is not intended to be a diagnostic device. Always contact your doctor for advice, diagnostic and treatment.
PRODUCT OVERVIEW
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse
Unit
Data transmitting
Low Battery
Time [Hour/Minute - Month/Day]
Irregular Heartbeat Detector
Start-StopUser 1
Start-StopUser 2
Pair-up
On/Off button
Cuff
Power socket
LCD display
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Switch the button « on » and press and hold User1 button to set time. Press button to change the numeral then press User1 button to confi rm. After confi rming [TIME] and [DATE], the LCD will display “Done”.
If the battery is low or empty, please recharge it with the authorized adaptor included in the pack.
Download the Terraillon Wellness Coach application.
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Create your account.
Turn on Bluetooth on your Smartphone (Setting > Bluetooth > ON).
Press and hold User2 button to start pair-up.
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FIRST USE
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Tie the cuff
Press User1 or User2 button to turn on the monitor, and it will complete the measurement process automatically
2~3cm
START MEASURING
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E1 Communication error. Check the app and Bluetooth.E3 The cuff is not secure. Refasten the cuff.E10/11 The monitor detected motion while measuring.E20 Measurement process does not detect the pulse signal E21 Measure incorrectly. Eexx A calibration error occurred.Lo Low Battery. Charge the battery.
EN
Press button to access the memory. Press User1 or User2 to recall the measurement history of each user.
Press and hold button for 3 seconds to clear the memory. When the LCD display “dEL ALL”, press button to confirm.
RECORDS
This product is guaranteed for 2 years against material and manufacturing defects. During this period, such defects will be repaired free of charge (proof of purchase must be presented if the scale is under warranty). This warranty does not cover damage resulting from accidents, improper use or negligence. If you have a complaint please contact the store where you purchased the product first.
Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.
WARRANTY & ENVIRONMENT PROTECTION
TIPS FOR MEASUREMENT
TROUBLESHOOTING
* The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH).
Optimal Normal High-normal Mild Moderate Severe
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
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BESOIN D’INFORMATION ?
http://www.terraillon.com
Nous vous remercions d’avoir choisi le tensiomètre bras TENSIOSMART de Terraillon.
Cet appareil vous permet de contrôler votre tension artérielle. Il n’a pas vocation à être un dispositif de diagnostic. Contactez toujours votre médecin pour obtenir tout conseil, diagnostic ou traitement.
APERÇU DU PRODUIT
Pression artérielle systolique
Pression artérielle diastolique
Pouls
Unité
Données en cours de transmission
Batterie faible
Heure [Heure/Minute - Mois/Jour]
Détecteur de rythme cardiaque irrégulier
Marche-ArrêtUtilisateur 1
Marche-ArrêtUtilisateur 2
Synchronisation
Bouton marche/arrêt
Brassard
Branchement chargeur
Écran LCD
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FR
Mettez le bouton en position « marche » puis maintenez enfoncé Utilisateur1 pour accéder au réglage de l’heure. Appuyez sur pour modifi er le chiffre puis cliquez sur le bouton Utilisateur1 pour confi rmer. Après avoir confi rmer [HEURE] et [DATE], l’écran LCD affi chera « Done».
Si la batterie est faible ou vide, branchez le produit sur une prise avec l’adaptateur fourni.
Téléchargez l’application Terraillon Wellness Coach.
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PREMIÈRE UTILISATION
Créez votre compte sur l’application.
Activez la fonction Bluetooth sur votre Smartphone (Réglages > Bluetooth > ON).
Appuyez sur le bouton Utilisateur2 et maintenez-le appuyé pour démarrer la synchronisation.
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Brassard
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Attachez le brassard.
Appuyez sur Utilisateur1 ou Utilisateur2 pour activer l’appareil. Votre prise de tension se fera de manière automatique.
CRÉEZ VOTRE COMPTE SUR L’APPLICATION
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2~3cm
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E1 Erreur de communication; Vérifiez l’application et le Bluetooth.E3 Le brassard est mal attaché. Veuillez le remettre correctement.E10/11 L’appareil a détecté un mouvement pendant la mesure.E20 Aucun signal de pouls n’a été détecté. E21 Mesure incorrecte. Eexx Une erreur d’étalonnage s’est produite.Lo Batterie faible. Veuillez recharger l’appareil.
Cet appareil est garanti 2 ans contre tout défaut matériel et de fabrication. Au cours de cette période, ces défauts seront réparés gratuitement (une preuve d’achat doit être présentée si la balance est sous garantie). Cette garantie ne couvre pas les dommages provenant d’accidents, d’une mauvaise utilisation ou de négligence. Si vous avez une réclamation, adressez-vous d’abord au magasin où vous avez acheté votre produit.
Les déchets de produits électriques ne doivent pas être jetés avec les ordures ménagères. Les recycler dans les installations prévues à cet effet. Contacter l’administration locale ou le détaillant pour tout conseil de recyclage.
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Appuyez sur le bouton pour accéder à la mémoire. Appuyez sur le bouton Utilisateur1 ou Utilisateur2 pour faire défiler l’historique de chaque utilisateur.
En mode rappel de mémoire, appuyez sur le bouton et maintenez-le enfoncé pendant 3 secondes pour effacer les enregistrements. Lorsque l’écran affiche “dEL ALL”, appuyez sur pour confirmer
MÉMOIRES
GARANTIE ET PROTECTION DE L’ENVIRONNEMENT
INDICATIONS POUR LA MESURE
DIAGNOSTIC
* Classification de la tension artérielle par l’Organisation Mondiale de la Santé (OMS) et la Société Internationale d’Hypertension (ISH).
Optimal Normal Normalà élevé Moyen Modéré Sévère
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
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MEER INFORMATIE OVER
http://www.terraillon.com
Bedankt om voor de Bloeddrukmeter TENSIOSMART van TERRAILLON te kiezen.
Met deze unit kunt u uw bloeddruk meten. Het apparaat is niet bedoeld om een diagnose te stellen. Wend u steeds tot uw arts voor advies, diagnose en behandeling.
OVERZICHT
Systolische bloeddruk
Diastolische bloeddruk
Hartslag
Unit
Gegevens worden overgedragen
Batterij bijna leeg
Tijd [Uur/Minuut - Maand/Dag]
Detector onregelmatige hartslag
Gebruiker 1
Gebruiker 2Koppeling
Aan / uit-knop
Polsband
Stopcontact
Lcd-scherm
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Zet de knop «Aan» en Houd de User1-toets 3 seconden ingedrukt om naar de tijdinstelmodus te gaan. Druk op om het cijfer te wijzigen en druk opnieuw op User1 om het te bevestigen. Nadat u [UUR] en [DATUM] hebt bevestigd, verschijnt de vermelding “Done” op het lcd-scherm schakelt.
Als de batterij bijna leeg is of leeg is, dan kunt u opladen met de bevoegde adapter meegeleverd in de verpakking.
Download de Terraillon Wellness Coach-app.
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EERSTE INSTALLATIE
Maak een account aan.
Schakel de Bluetooth-functie van uw smartphone in (Instellingen > Bluetooth > AAN).
Houd de “Gebruiker 2”-toets om de koppeling te starten.
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Polsband
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De polsband bevestigen.
Drukt u op “Gebruiker 1/2”-toets om de meter in te schakelen. Deze zal het meetproces automatisch voltooien.
BEGINNEN MET METEN
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E1 Communicatie fout. Controleer de app en Bluetooth.E3 De manchet is niet veilig. Weer vast de manchet.E10/11 De meter detecteerde beweging tijdens het meten.E20 Het meetproces detecteert geen hartslagsignaal.E21 Onjuiste meting.Eexx Er is een ijkingsfout opgetreden.Lo Batterij bijna leeg. De batterij opladen.
Voor dit toestel geldt een garantie van 2 jaar tegen materiaal- en fabricagefouten. Gedurende deze periode zullen dergelijke defecten gratis gerepareerd worden (tijdens de garantieperiode moet een bewijs van aankoop worden overgelegd). Schade veroorzaakt door ongevallen, onjuist gebruik of nalatigheid valt niet onder de garantie. Als u klachten hebt, dient u zich in eerste instantie te wenden tot de winkel waar u de monitor heeft gekocht.
Afgedankte elektrische producten horen niet bij het huishoudelijk afval. Gelieve te recycleren waar mogelijk. Raadpleeg uw lokale overheid of verkoper voor recyclingadvies.
Optimaal Normaal Hoog-normaal Licht Matig Ernstig
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
NL
Druck op om toegang te krijgen tot het geheugen. Druk op Gebruiker 1 of Gebruiker 2 om de opgeslagen gegevens te doorbladeren.
Houd in de oproepmodus de toets 3 seconden ingedrukt om Gegevens te wissen. “dEL ALL” verschijnt op het lcd-scherm, druk opnieuw op om het te bevestigen.
GEGEVENS
GARANTIE & BESCHERMING VAN HET LEEFMILIEU
MEETTIPS
PROBLEMEN OPLOSSEN
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TROVATE MAGGIORI INFORMAZIONI SUL
http://www.terraillon.com
Grazie per aver scelto TENSIOSMART il monitor per la misurazione della pressione sanguigna TERRAILLON.
L’unità permette di monitorare la pressione del sangue. Il dispositivo non è pensato come apparecchio di diagnosi. Contattare sempre il proprio medico per consigli, diagnosi e terapia.
IN SINTESI
Utente 1
Utente 2Sincronizzazione
Pulsante On / Off
Bracciale
Presa energia
Display LCD
Pressione arteriosa sistolica
Pressione arteriosa diastolica
Pulsazioni
Unità
Trasmissione dati
Batteria scarica
Data/ora [Ore/Minuti - Mese/Giorno]
Rilevatore battito cardiaco irregolare
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Accendere il tasto «on» e mantenere premuto il tasto User1 per 3 secondi per entrare nella modalità impostazione data/ora. Premere il tasto per modifi care il numero e premere nuovamente il tasto Utente 1 per confermare. Dopo aver confermato [ORA] e [DATA], il display LCD mostra “Done”.
Se la batteria è basso o vuoto, si prega di ricaricarla con l’adattatore autorizzato incluso nella confezione.
Scaricare l’app Terraillon Wellness Coach.
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Creare un account.
Attivare la funzione Bluetooth sullo Smartphone (Impostazioni > Bluetooth > ON).
Tenere premuto il tasto “Utente 2 ” per avviare l’accoppiamento.
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PRIMA INSTALLAZIONE
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Fissaggio del bracciale.
Premere “Utente1”/”Utente2” per accendere il monitor che completerà automaticamente la procedura di misurazione.
AVVIARE LE MISURAZIONI
2~3cm
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E1 Errore di comunicazione. Controllare l’applicazione e Bluetooth.E3 Il bracciale non è sicuro. Fissare nuovamente il bracciale.E10/11 Il monitor ha rilevato un movimento durante la misurazione.E20 La procedura di misurazione non rileva il segnale del polso.E21 Misurazione incorretta.Eexx Si è verificato un errore di calibrazione.Lo Batteria scarica.
Questo prodotto è garantito per 2 anni contro difetti di materiale e di fabbricazione. Durante questo periodo, tali difetti saranno riparati gratuitamente (presentare la prova di acquisto se la bilancia è sotto garanzia). Questa garanzia non copre i danni derivanti da incidenti, uso improprio o negligenza. In caso di reclamo contattare il negozio presso cui è stata acquistata il monitor.
I rifiuti di apparecchiature elettriche non devono essere smaltiti come rifiuti domestici. Riciclare dove esistono strutture atte allo scopo. Consultare le autorità locali o il rivenditore per indicazioni riguardanti il riciclaggio.
Ottimale Normale Alto-normale Lieve Moderato Grave
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
IT
Premere il tasto per accedere alla memoria. Premere il tasto Utente1 oppure Utente2 per modificare la disposizione delle registrazioni della cronologia.
In modalità di accesso memoria, tenere premuti contemporaneamente per 3 secondi il tasto per l’eliminazione delle registrazioni. Lo schermo LCD mostrerà il messaggio “dEL ALL”, premere nuovamente il tasto per confermare.
REGISTRAZIONI
GARANZIA & PROTEZIONE DELL’AMBIENTE
SUGGERIMENTI PER LA MISURAZIONE
RISOLUZIONE DEI PROBLEMI
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ENCONTRAR MÁS INFORMACIÓN SOBRE
http://www.terraillon.com
Muchas gracias por haber elegido el tensiómetro TENSIOSMART de TERRAILLON.
Esta unidad le permite controlar su tensión arterial. Este dispositivo no ha sido diseñado como dispositivo de diagnóstico. Para recibir asesoramiento, diagnóstico y tratamiento, consulte siempre a su médico.
DESCRIPCIÓN GENERAL
Tensión arterial sistólica
Tensión arterial diastólica
Pulso
Unidad
Transmisión de datos
Batería baja
Hora [Hora / minuto - Mes / día]
Detector de latidos irregulares
Usuario 1
Usuario 2Sincronización
Botón de encendido / apagado
Manguito
Toma de corriente
Pantalla LCD
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Cambie el botón «encendido» y mantenga pulsado el botón User1 durante 3 segundos para entrar en el modo de ajuste de hora. Pulse el botón para cambiar el número y vuelva a pulsar el botón Usuario 1 para confi rmar. Una vez confi rmados los [TIEMPO] y el [FECHA], en la pantalla LCD aparecerá el mensaje «Done».
Si la batería está bajo o vacío, por favor recarga con el adaptador autorizado incluido en el paquete.
Descargue la aplicación Terraillon Wellness Coach.
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Cree una cuenta.
Active la función Blueetooth en su smartphone (Ajustes > Blueetooth > ACTIVADO).
Mantenga pulsado el botón “Usuario 2” para iniciar el emparejamiento.
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INSTALACIÓN INICIAL
Manguito
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Fijación del manguito.
Pulse “Usuario1”/ “Usuario2” para encender el tensiómetro y este realizará el proceso de medición de forma automática.
COMENZAR A MEDIR
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E1 Error de comunicacion. Compruebe la aplicación y Bluetooth.E3 El brazalete no es seguro. Vuelva a ajustar el brazalete.E10/11 El tensiómetro ha detectado movimiento durante la medición.E20 El proceso de medición no detecta la señal de pulso.E21 Medición incorrecta.Eexx Error de calibración.Lo Batería baja. Recargar la batería.
El producto está garantizado por un período de dos años contra todo defecto de material y de fabricación. Durante dicho período, los problemas de este tipo se repararán gratuitamente, previa presentación de un justificante de compra. La garantía no cubre los daños resultantes de accidentes, uso indebido o negligencia. Si tiene una reclamación, le rogamos se ponga en contacto, en primer lugar, con la tienda en la que adquirió el producto.
Los productos eléctricos no deben desecharse con la basura doméstica. Recíclelos en las instalaciones disponibles. Consulte a las autoridades locales o al comerciante para informase sobre el reciclado.
Óptima Normal Normal-alta Leve Moderada Grave
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
ES
Pulse el botón para acceder a la memoria. Pulse el botón Usuario 1 o Usuario 2 para moverse por los registros del historia.
En el modo de consulta de memoria, mantenga pulsados el botón durante 3 segundos para el eliminación de registros. La pantalla LCD mostrará el mensaje «dEL All», vuelva a pulsar el botón para confirmar.
REGISTROS
GARANTÌA & PROTECCIÓN MEDIOAMBIENTAL
CONSEJOS PARA REALIZAR MEDICIONES
SOLUCIÓN DE PROBLEMAS
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MEHR INFORMATIONEN FINDEN SIE
http://www.terraillon.com
Vielen Dank, dass Sie sich für ein TERRAILLON Blutdruckmessgerät TENSIOSMART entschieden haben.
Dieses Gerät ermöglicht Ihnen die Kontrolle Ihres Blutdrucks. Es ist nicht für diagnostische Zwecke bestimmt. Für Diagnose, Rat und Behandlung sollten Sie stets Ihren Arzt aufsuchen.
FUNKTIONEN
Systolischer Blutdruck
Diastolischer Blutdruck
Puls frequenz
Gerät
Datenübertragung
Batterie schwach
Zeit [Stunde/Minute - Monat/Tag]
Melder für unregelmäßigen Herzschlag
Benutzer 1
Benutzer 2Synchronisation
Ein / Aus-Taste
Manschette
Steckdose
LCD-Display
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Schalten Sie den Knopf «auf» und halten Sie die User1-Taste 3 Sekunden lang gedrückt, um den Zeiteinstellungsmodus aufzurufen. Drücken Sie die Taste um die Zahl zu ändern und Drücken Sie erneut Benutzer 1, um die Zahl zu bestätigen. Nachdem Sie [ZEIT] und [DATUM]bestätigt haben, erscheint die Meldung „Done“ auf dem Display.
Wenn die Batterie schwach oder leer ist, laden Sie ihn bitte mit dem autorisierten Adapter in der Packung enthalten.
Laden Sie die App Terraillon Wellness Coach herunter.
A
Legen Sie ein Konto an.
Aktivieren Sie die Bluetooth-Funktion auf Ihrem Smartphone (Einstellungen > Bluetooth > ON).
Halten Sie die “Benutzer 2” -Taste um das Koppeln zu aktivieren.
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ERSTINSTALLATION
Manschette
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Anbringen der Manschette.
Drücken Sie “Benutzer1”/ “Benutzer2”--Taste, um das Gerät einzuschalten. Dann erfolgt die Messung automatisch.
ERSTE MESSUNGEN
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E1 Kommunikationsfehler. Überprüfen Sie die App und Bluetooth.E3 Die Manschette ist nicht sicher. Befestigen Sie wieder die Manschette.E10/11 Das Gerät hat während der Messung eine Bewegung erkannt.E20 Während der Messung wurde kein Pulssignal erfasst.E21 Falsche Messung.Eexx Ein Kalibrationsfehler ist aufgetreten.Lo Niedriger Batteriestatus. Lade die Batterie auf.
Für dieses Produkt besteht eines 2-Jahres-Garantie gegen Material- und Fabrikationsfehler. Während dieses Zeitraums werden diese Fehler kostenlos repariert (wenn die Waage unter Garantie steht, muss ein Kaufnachweis vorgelegt werden). Diese Garantie deckt keine Schäden, die aus Unfällen, unsachgemäßer Verwendung oder Nachlässigkeit entstehen. Bei Reklamationen wenden Sie sich bitte an das Geschäft, in dem Sie die Blutdruckmessgerät erworben haben.
Elektrische Geräte getrennt von Hausmüll entsorgen. Bitte nach Möglichkeit recyceln. Erkundigen Sie sich bei Ihrem Händler oder Ihrer Gemeinde nach Recyclingmöglichkeiten.
Optimal Normal Hoch-normal Leichte Hypertonie
MittlereHypertonie
SchwereHypertonie
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
DE
Drücken Sie , um auf den Speicher zuzugreifen. Drücken Sie Benutzer 1 oder Benutzer 2, um die gespeicherten Ergebnisse einzusehen.
Halten Sie im Speicher-Aufruf-Modus gleichzeitig die Taste 3 Sekunden lang gedrückt, um die Daten zu löschen. Erscheint „dEL ALL“ im Display, drücken Sie erneut , um zu bestätigen.
DATEN
GARANTIE & UMWELTSCHUTZSYMBOL
TIPPS ZUR MESSUNG DES BLUTDRUCKS
PROBLEMLÖSUNG
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OBTENHA MAIS INFORMAÇÕES SOBRE
http://www.terraillon.com
Muito obrigado por escolher TENSIOSMART o Monitor de Pressão Sanguínea TERRAILLON.
Esta unidade permite-lhe controlar a sua pressão sanguínea. Este dispositivo não se destina a ser utilizado como dispositivo de diagnóstico. Contacte sempre o seu médico relativamente a diagnósticos, aconselhamento e tratamento.
VISÃO GERAL
Pressão Sanguínea Sistólica
Pressão Sanguínea Diastólica
Batimentos cardíacos
Unidade
Dados em transmissão
Pilha Fraca
Tempo [Hora/Minuto - Mês/Dia]
Detetor de batimentos cardíacos irregulares
Utilizador 1
Utilizador 2Sincronização
Botão On / Off
Bracelete
Tomada de alimentação
Ecrã LCD
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Mudar o botão «on» e prima e mantenha premido o botão User1 durante 3 segundos, para entrar no Modo de Defi nição do Tempo. Prima o botão para alterar o número e prima novamente o botão Utilizador 1 para confi rmar. Depois de confi rmar os [HORA] e [DATA], o LCD apresenta a mensagem “Done”.
Se a bateria estiver baixo ou vazio, por favor, recarregá-lo com o adaptador autorizado incluído no pacote.
Descarregue a aplicação Terraillon Wellness Coach.
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PRIMEIRA INSTALAÇÃO
Crie uma conta.
Active a função Bluetooth no Smartphone (Defi nições > Bluetooth > Ligado).
Mantenha premido o botão “Utilizador 2” para iniciar a sincronização.
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Bracelete
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Coloque a bracelete.
Prima “Utilizador 1/Utilizador 2” para ativar o monitor. Este completará o procedimento de medição automaticamente.
COMEÇAR A UTILIZAÇÃO
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E1 Erro de comunicação. Verifique o aplicativo e BluetoothE3 O manguito não é seguro. Refasten o manguito.E10/11 O monitor detetou movimento durante a medição.E20 O processo de medição não deteta batimentos cardíacos.E21 Medição incorreta.Eexx Ocorreu um erro de calibração.Lo Bateria fraca. Carregue a bateria.
Este aparelho é garantido 2 anos contra qualquer defeito material e de fabrico. Durante este período, os defeitos serão reparados gratuitamente (uma prova de compra deve ser apresentada se a balança estiver abrangida pela garantia). Esta garantia não cobre os danos resultando de acidentes, utilização incorrecta ou negligência. Se quiser apresentar uma reclamação, dirija-se em primeira instância à loja onde comprou o aparelho.
Equipamentos elétricos desativados não devem ser eliminados juntamente com os resíduos domésticos. Entregue num ponto de reciclagem existente. Consulte as autoridades locais ou o revendedor para obter informação sobre a reciclagem.
Ótimo Normal Elevada-normal Ligeira Moderato Grave
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
PT
Prima o botão para aceder à memória. Prima o botão Utilizador 1 ou Utilizador 2 para avançar ou retroceder nos registos.
Prima o botão No Modo de Chamada de Memória, prima e mantenha premido o botão durante 3 segundos para eliminar Registos. O LCD apresenta a informação “dEL ALL” , prima novamente o botão para confirmar
REGISTOS
GARANTIA & PROTEÇÃO AMBIENTAL
SUGESTÕES DE MEDIÇÃO
RESOLUÇÃO DE PROBLEMAS
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General Description* Thank you for selecting TERRAILLON Blood pressure Monitor (LS808-B).
The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime.
* This manual contains important safety information and caution, and provides step by step instructions for using the product.
* Please do read this user manual carefully and thoroughly before use.
FEATURES:86.1mm×24mm Blue LCD Display with White BacklightMeasure-during-inflating TechnologyUp to 60 pieces of record stored
Indications for UseThe TERRAILLON Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ).It is intended for adult indoor use only.
Measurement PrincipleThis product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to deter-mine the systolic pressure and diastolic pressure as well as pulse rate. The device also compares the longest and the shortest intervals of detected pulse wave to with the average value, and then calculates the standard deviation.
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Safety InformationThe below signs might be in the user manual, labeling or other components.They are the requirement of standard and using.
CAUTION
This device is intended for adult use only. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result. If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the corresponding user button to stop inflation. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch output of adapter and the patient simultaneously. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. The device doesn’t need to be calibrated within the two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of TERRAILLON. Don’t open or repair the device by yourself. Please report to TERRAILLON if any unexpected operation or events occur. Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
Symbol for “THE OPERATION GUIDE MUST BE READ”
Symbol for “TYPE BF APPLIED PARTS”
Symbol for “COMPLIES WITH MDD93/42/EEC REQUIREMENTS”
Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”
Symbol for “MANUFACTURER”
Symbol for “DIRECT CURRENT”
Symbol for “SERIAL NUMBER” EC REPSymbol for “Authorised Representative in the European Community”
The Bluetooth Combination Mark T1A/250V 3.6*10CCC
Symbol for “MANUFACTURE DATE For indoor use only
Symbol for “Class II Equipment” Caution: These notes must be observed to prevent any damage to the device.Symbol for “Including RF transmitter”
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Tips for MeasurementMeasurements may be inaccurate if taken in the following circumstances.
Within 1 hour after dinner or drinking
Within 20 minutes after taking a bath
In a very coldenvironment
Immediate measurement after tea, coffe, smoking
When talking or moving your fingers
When you want to discharge urine
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MaintenanceTo obtain the best performance, please follow below instructions.
Put in a dry place and avoid the sunshine
Avoid intense shaking and collisions
Use the slightly damp cloth to remove the dirt
Avoid immersing it in the water.Celan it with a dry cloth in case
Avoid dusty environment and unstable temperature
surrounding
Avoid washing the cuff
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What are systolic pressure and diastolic pressure?When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.
What is the standard blood pressure classification?The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:
Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.
Irregular Heartbeat DetectorAn irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.
press
artery veinblood dischargingSystolic
relax
blood enteringDiastolic
CAUTION
CAUTION
Óptima Normal Normal-alta Leve Moderada Grave
SYS <120 120-129 130-139 140-159 160-179 ≥180
DIA <80 80-84 85-89 90-99 100-109 ≥110
LevelBloodPressure (mm Hg)
Grade 2 hypertension (moderate)
Grade 3 hypertension (severe)
High-normal BloodPressure
Grade 1 hypertension (mild)
Normal Blood Pressure
Subgroup: borderline
Optimal Blood
PressureDia
sto
lic b
loo
d p
ress
ure
(m
mH
g)
110
120 150130 160140 180
95
85
100
90
80
Systolic blood pressure (mmHg)
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.
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Why does my blood pressure fluctuate throughout the day?1. Individual blood pressure varies
multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.
Why do I get a different blood pressure at home comparedto the hospital?The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.
Is the result the same if measuring on the right arm?It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.
What you need to pay attention to when you measure your blood pressure at home:
If the cuff is tied properly.If the cuff is too tight or too loose.If the cuff is tied on the upper arm.If you feel anxious.Taking 2-3 deep breaths before beginning will be better for measuring.Advice: Relax yourself for 4-5 minutes until you calm down.
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WARNING: No modification of this equipment is allowed.
Power supply 3.7V 1000mAH Built-in rechargeable li-polymerbattery, 6V 1A AC Adaptor
Display mode Blue LCD with White BacklightV.A.= 86.1mm(L) x24mm(W)
Measurement mode Oscillographic testing mode
Measurement range
Rated cuff pressure:0kPa-40kPa(0mmHg-300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg)pulse value:(40-199)beat/minute
AccuracyPressure:5°C-40°C within±0.4kPa(3mmHg)pulse value:±5%
Normal working conditionTemperature:5°C to 40°CRelative humidity: ≤85%RHAtmospheric pressure: 86kPa to 106kPa
Storage & transportation conditionTemperature:-20°C to 60°CRelative humidity: 10%RH to 93%RHAtmospheric pressure: 50kPa to 106kPa
Measurement perimeter of the upper arm About 22cm-32cm
Net Weight Approx.284 g
External dimensions Approx.130.9mm×73mm×29.4mm
Attachment AC Adaptor,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection againstingress of water
IP22, It means the device could protectedagainst solid foreign objects of 12.5 mm andgreater, and against vertically falling waterdrops when ENCLOSURE tilted up to 15°
Software version V01
Device classification Battery Powered Mode:Internally Powered ME EquipmentAC Adaptor charged Mode:Class II ME Equipment
SPECIFICATIONS
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Complied European Standards List
Risk management ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices
LabelingISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
User manual EN 1041: 2008 Medical equipment manufacturers to provide information
General Requirements for Safety
EN 60601-1: 2006+A1:2013 Medical electrical equipment- Part 1: General requirements for basic safety and
essential performanceIEC/EN 60601-1-11: 2010 Medical electrical equipment --Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC/EN 80601-2-30:2009 Medical electrical equipment -Part 2-30: Particular requirements for the basic safety
and essential performance of automated noninvasive sphygmomanometers
Electromagneticcompatibility
IEC/EN 60601-1-2:2007 Medical electrical equipment -Part 1-2: General requirements for basic safety
and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
Performancerequirements
EN 1060-1:1995+A2:2009 Non-invasive blood pressurePart 1: General requirementsEN 1060-3:1997+A2:2009 Non-invasive blood pressurePart 3: Supplementary requirements for electromechanical blood pressure measuring system
Clinical investigationEN 1060-4: 2004 Automatic Blood Pressure Monitoroverall system Interventional accuracy of the testing process
Usability
IEC/EN 60601-1-6: 2010 Medical electrical equipment --Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard: Usability
IEC/EN 62366: 2007 Medical devices - Application of usability engineering to medical devices
Software life-cycle processes IEC/EN 62304:2006+AC: 2008 Medical device software- Software life cycle processes
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EMC Guidance1) This equipment needs to be installed and put into service in accordance with
the information provided in the user manual;
2) Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d=3,3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)
Athorized Component 1. Please use the TERRAILLON authorized adaptor
AdaptorInput: 100-240V~50/60Hz 0.3A MaxOutput: 6V 1A
CAUTION
1. The battery of LS808-B is built-in rechargeable li-polymer battery, please do not disassemble it by the unauthorized maintenance personel.
2. Under the normal using, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personel. If measured three times per day, and the battery is fully charged, it can be used for about 20 days.
3. Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid to approach to the fire and the heat source, or it will cause the battery explode.
4. Only can use the TERRAILLON’s authorized AC Adaptor(6V 1A) to charge the power. You cannot use the blood pressure monitor during the process of charging.
5. During the process of charging, the blood pressure monitor display When the charging is finished, please pull the plug in time.
6. When charging, shall not touch charging connector and the patient simultaneously.
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Table 2Guidance and manufacturer’s declaration – electromagnetic immunity – for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The LS802-B is intended for use in the electromagnetic environment specified below.The customer of the user of the LS802-B should assure that it is used in such an environment
Immunity test IEC 60601 test level Compliance level Electromagnetic
environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact±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 humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines
±2kV forpower supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV line(s) to line(s)
±1 kVdifferential mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT(>95% dip in UT )for 0.5 cycle
<5% UT(>95% dip in UT )for 0.5 cycle
Mains power quality should be that of a typical commercial or hospital environment. If the user of LS802-B requires continued operation during power mains interruptions, it is recommended that LS-802-B be powered from an interruptible power supply or a battery.
40% UT(60% dip in UT )for 5 cycles
40% UT(60% dip in UT )for 5 cycles
70% UT(30% dip in UT )for 25 cycles
70% UT(30% dip in UT )for 25 cycles
<5% UT(>95% dip in UT )for 5 sec
<5% UT(>95% dip in UT )for 5 sec
Power frequency (50Hz) magnetic fieldIEC 61000-4-8
3A/m 3A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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Table 4Guidance and manufacturer’s declaration – electromagnetic immunity – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The LS802-B is intended for use in the electromagnetic environment specifi ed below.The customer of the user of the LS802-B should assure that it is used in such an environment.
Immunity test IEC 60601test level
Compliancelevel
Electromagneticenvironment - guidance
Conducted RFIEC 61000-4-6
3 Vrms150 kHz to80 MHz 3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of the LS802-B, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.167
d = 1.167 80 MHz to 800 MHz
d = 2.333 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture and d is the recommended separation distance in metres (m).
Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey, ashould be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RFIEC 61000-4-3
3 V/m80 MHz to2.5 GHz
3 Vrms
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and refl ection from structures, objects and peoplea Field strengths from fi xed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the LS802-B is used exceeds the applicable RF compliance level above, the LS802-B should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LS802-B.
b Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3V/m.
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Table 6Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTING
Recommended separation distancesbetween portable and mobile RF communications equipment at the LS802-B.
The LS802-B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LS802-B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the LS802-B as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.167
80 MHz to 800 MHz
d = 1.167
800 MHz to 2.5 GHz
d = 2.333
0.01 0.167 0.167 0.233
0.1 0.369 0.369 0.738
1 1.167 1.167 2.333
10 3.690 3.690 7.338
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and people.
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTDZone A, 5/F., Investment Building, No. 12, Huizhan East Rd., TorchDevelopment District, Zhongshan, Guangdong, 528437, China
MDSS - Medical Device Safety Service GmbHSchiffgraben 41, 30175 Hannover, Germany
EC REP
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Terraillon Corp [email protected]