Symbols Glossary (English, Spanish, French, Italian, German, Dutch, Swedish, Danish, Finnish, Norwegian, Portuguese) Number 5.1.6

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1 Symbols Glossary (English, Spanish, French, Italian, German, Dutch, Swedish, Danish, Finnish, Norwegian, Portuguese) Page 1 Symbol & Title Catalogue Number Batch Code Sterilized using irradiation Sterilized using ethylene oxide Definition Catalogue number Número de catálogo Référence catalogue Numero di catalogo Bestellnummer Catalogusnummer Katalognummer Katalognummer Tuotenumero Katalognummer Número de catálogo Batch code Código de lote Numéro de lot N. lotto Chargencode Batchcode Batchnummer Batchnummer Eränumero Partinummer Número de lote Sterilized using irradiation Esterilizado mediante radiación Stérilisé par irradiation Sterilizzato tramite irraggiamento Mit Strahlung sterilisiert Gesteriliseerd met straling Steriliserad med bestrålning Steriliseret med stråling Steriloitu säteilyttämällä Sterilisert med stråling Esterilizado com irradiação Sterilized using ethylene oxide Esterilizado mediante óxido de etileno Stérilisé par oxyde d'éthylène Sterilizzato mediante ossido di etilene Mit Ethylenoxid sterilisiert Gesteriliseerd met ethyleenoxide Steriliserad med etylenoxid Steriliseret med etylenoxid Steriloitu käyttämällä etyleenioksidia Sterilisert med etylenoksid Esterilizado com óxido de etileno Title & Designation Number of Standard Symbol Reference Number

2 Page 2 Sterile Do Not Reuse Do not resterilize Do not use if package is damaged Sterile Estéril Stérile Sterile Steril Steriel Steril Steril Steriili Steril Esterilizado Do not reuse No reutilizar Ne pas réutiliser Non riutilizzare Nicht wiederverwenden Niet hergebruiken Får inte återanvändas Ikke til flergangsbrug Ei saa käyttää uudelleen Skal ikke gjenbrukes Não reutilize Do not resterilize No reesterilizar Ne pas restériliser Non risterilizzare Nicht resterilisieren Niet opnieuw steriliseren Får inte återsteriliseras Må ikke resteriliseres Ei saa steriloida uudelleen Skal ikke resteriliseres Não reesterilize Do not use if package is damaged No utilice el producto si el envoltorio está dañado Ne pas utiliser si l'emballage est endommagé Non utilizzare se la confezione è danneggiata Nicht verwenden, wenn die Verpackung beschädigt ist Niet gebruiken indien de verpakking is beschadigd Får inte användas om förpackningen är skadad Må ikke anvendes, hvis pakningen er beskadiget Älä käytä, jos pakkaus ei ole ehjä Skal ikke brukes hvis pakningen er skadet Não utilize se a embalagem estiver danificada

3 Page 3 Caution CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. PRECAUCIÓN: las leyes federales de los Estados Unidos solo permiten la venta de este dispositivo por parte un médico o por prescripción facultativa. ATTENTION : la loi fédérale américaine stipule que la vente de ce dispositif est réservée aux médecins ou sur prescription médicale ATTENZIONE: la legge federale statunitense limita la vendita di questo dispositivo a medici o su prescrizione medica. VORSICHT: US-Bundesgesetz beschränkt den Verkauf dieses Produkts an einen Arzt oder auf dessen Anordnung. Let op: Krachtens de federale wetgeving van de VS mag dit hulpmiddel alleen door of in opdracht van een arts worden gekocht. FÖRSIKTIGHET: Enligt federal lag (USA) får den här produkten endast säljas av eller på ordination av läkare. FORSIGTIG: Ifølge amerikansk lovgivning må denne anordning kun sælges af eller på foranledning af en læge. VAROITUS: Liittovaltion (Yhdysvallat) lain mukaan tätä laitetta saa myydä vain lääkäri tai lääkärin määräyksestä. FORSIKTIG: Føderal lov (USA) begrenser salg av dette utstyret til leger eller etter ordre fra leger. CUIDADO: o direito federal dos E.U.A. restringe a venda deste dispositivo por ou em nome de um médico. Caution, consult accompanying documents Precaución: consulte documentos adjuntos Attention, consulter les documents joints Attenzione, consultare la documentazione allegata Vorsicht, Begleitdokumente beachten Let op: raadpleeg de bijbehorende documenten. Iakttag försiktighet, konsultera medföljande dokument Forsigtig, læs de medfølgende dokumenter Varoitus, lue mukana toimitetut asiakirjat Forsiktig, se medfølgende dokumenter Cuidado, consulte os documentos complementares 21 CFR

4 Page 4 Caution Use By Date Consult Instructions for Use Operating Instructions Upper limit of temperature Caution Precaución Attention Attenzione Vorsicht Let op Iakttag försiktighet Forsigtig Varoitus Forsiktig Cuidado Use by date Fecha de caducidad À utiliser avant Data di scadenza Verfalldatum Houdbaarheidsdatum Använd före Anvendes inden Viimeinen käyttöpäivämäärä Utløpsdato Data de validade Consult instructions for use Consulte las instrucciones de uso Consulter le mode d'emploi Consultare le istruzioni per l'uso Gebrauchsanweisung beachten Raadpleeg de gebruiksaanwijzing Se bruksanvisningen Se brugsanvisningen Lue käyttöohjeet Se bruksanvisningen Consulte as instruções de utilização Follow operating instructions Siga las instrucciones de funcionamiento Suivre les instructions d'utilisation Attenersi alle istruzioni per il funzionamento Bedienungsanweisung beachten Volg de bedieningsinstructies Följ användarhandboken Følg betjeningsvejledningen Noudata käyttöohjeita Følg bruksinstruksjonene Siga as instruções de funcionamento Upper limit of temperature Límite superior de temperatura Température maximale Limite superiore di temperatura Obere Temperaturbegrenzung Bovengrens temperatuur Övre temperaturgräns Øvre temperaturgrænse Lämpötilan yläraja Øvre temperaturgrense Limite superior de temperatura ISO A ISO

5 Page 5 Lower limit of temperature Temperature limitation Non-pyrogenic Follow Instructions for Use Follow Instructions for Use Lower limit of temperature Límite inferior de temperatura Température minimale Limite inferiore di temperatura Untere Temperaturbegrenzung Ondergrens temperatuur Nedre temperaturgräns Nedre temperaturgrænse Lämpötilan alaraja Nedre temperaturgrense Limite inferior de temperatura Temperature limitation Límites de temperatura Limite de température limiti temperatura Temperaturbegrenzung Beperking temperatuur Temperaturgräns Temperaturbegrænsning Lämpötilaa koskeva rajoitus Temperaturgrenser Limitação de temperatura Non-pyrogenic No pirogénico Non pyrogène Apirogeno Nicht pyrogen Niet-pyrogeen Icke-pyrogen Ikke-pyrogen Pyrogeeniton Ikke-pyrogen Não pirogénico Follow instructions for use Siga las instrucciones de uso Suivre le mode d'emploi Attenersi alle istruzioni per l'uso Gebrauchsanweisung befolgen Volg de gebruiksaanwijzing Följ bruksanvisningen Følg brugsanvisningen Noudata käyttöohjeita Følg bruksanvisningen Siga as instruções de utilização Follow instructions for use Siga las instrucciones de uso Suivre le mode d'emploi Attenersi alle istruzioni per l'uso Gebrauchsanweisung befolgen Volg de gebruiksaanwijzing Följ bruksanvisningen Følg brugsanvisningen Noudata käyttöohjeita Følg bruksanvisningen Siga as instruções de utilização IEC TR 60878:ed2:2003 Graphical symbols for electrical equipment in medical practice 1:ed3:2005/A1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance Safety 01 ISO M002

6 Page 6 Humidity limitation Serial number MR Conditional MR Safe MR Unsafe Humidity limitation Límites de humedad Limite d'humidité Limiti umidità Feuchtigkeitsbegrenzung Beperking luchtvochtigheid Luftfuktighetsgräns Fugtighedsbegrænsning Kosteutta koskevat rajoitukset Fuktighetsgrenser Limitação de humidade Serial number Número de serie Numéro de série Numero di serie Seriennummer Serienummer Serienummer Serienummer Sarjanumero Serienummer Número de série Magnetic resonance conditional Condicionado por resonancia magnética Compatibilité IRM conditionnelle A compatibilità condizionata con risonanza magnetica Bedingt MR-sicher MR-conditioneel MR-villkorad Betinget MR-sikker Magneettikuvaus ehdollinen MR-betinget Condicional para ressonância magnética Magnetic resonance safe Seguro ante resonancia magnética Compatible IRM compatibile con risonanza magnetica MR-sicher MR-veilig MR-säker MR-sikker Magneettikuvaus turvallinen MR-sikker Seguro para ressonância magnética Magnetic resonance unsafe No seguro ante resonancia magnética Non-compatible IRM non compatibile con risonanza magnetica Nicht MR-sicher MR-onveilig Ej MR-säker Ikke MR-sikker Magneettikuvaus ei turvallinen MR-usikker Não seguro para ressonância magnética ASTM F 2503:2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ASTM F 2503:2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ASTM F 2503:2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

7 Page 7 Contains or presence of phthalate Non-sterile Stand-by Non-ionizing radiation Contains or presence of phthalate Contiene o puede presentar ftalato Contient/Présence de phtalates Presenza di/contiene ftalato Enthält oder Anwesenheit von Phthalaten Bevat of aanwezigheid van ftalaten Innehåller eller förekomst av ftalat Indeholder ftalater Sisältää ftalaatteja Inneholder ftalat Contém ftalato ou vestígios da substância Non-sterile Sin esterilizar Non stérile Non sterile Nicht steril Niet-steriel Icke-steril Ikke-steril Epästeriili Ikke-steril Não esterilizado Stand-by En espera Veille Standby Standby Stand-by Standby Standby Valmiustila Standby Em espera Non-ionizing radiation Radiación no ionizante Rayonnement non-ionisant Radiazione non ionizzante Nichtionisierende Strahlung Niet-ioniserende straling Icke-joniserande strålning Ikke-ioniserende stråling Ionisoimaton säteily Ikke-ioniserende stråling Radiação não ionizante BS EN 15986:2011 Symbol for use in the labelling of medical devices Requirements for labelling of medical devices containing phthalates EN : Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ISO

8 Page 8 Separate collection for waste of electrical and electronic equipment. Alternating current Type BF Applied Part Protected against splashing water Separate collection for waste of electrical and electronic equipment. Recogida independiente para el desecho de equipos eléctricos y electrónicos Collecte sélective des équipements électriques et électroniques Raccolta separata per rifiuti di apparecchiature elettriche ed elettroniche Getrennte Abfallentsorgung von elektrischen und elektronischen Geräten Aparte inzameling van afval van elektrische en elektronische apparatuur Separat insamling av elektriskt och elektroniskt avfall Separat indsamling af affald fra elektrisk og elektronisk udstyr Kierrätettävä sähkö- ja elektroniikkalaiteromuna Separat innsamling for avfall fra elektrisk og elektronisk utstyr. Separe para a recolha de resíduos de equipamento elétrico e eletrónico Alternating current Corriente alterna Courant alternatif Corrente alternata Wechselspannung Wisselstroom Växelström Vekselstrøm Vaihtovirta Vekselstrøm Corrente alternada Type BF Applied Part Pieza aplicada de tipo BF Pièce appliquée de type BF Parte applicata di tipo BF Anwendungsteil des Typs BF Type BF toegepast onderdeel Typ BF tillämpad del Type BF-anvendt del Tyypin BF sovellettu osa Anvendt del av type BF Peça aplicada tipo BF Protected against splashing water Protegido contra salpicaduras de agua Protégé contre les éclaboussures d'eau Protetto contro gli spruzzi d'acqua Vor Spritzwasser geschützt Beschermd tegen spatwater Skyddad mot vattenstänk Beskyttet mod vandstænk Roiskevesisuojattu Beskyttet mot vannsprut À prova de salpicos EN Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC IEC AMD1:1999+ AMD2:2013CSV/COR2:2015 Degrees of protection provided by enclosures (IP code)

9 Page 9 Defibrillation-proof type CF applied part On Off Equipotentiality Defibrillation-proof type CF applied part Pieza a prueba de desfibrilación tipo CF Équipement de type CF protégé contre les défibrillateurs Compatibile con defibrillatori con parte applicata di tipo CF Defibrillationssicheres Anwendungsteil des Typs CF Type CF defibrillatiebestending toegepast onderdeel Defibrilleringssäker patientansluten del, typ CF Defibrillationssikker type CF anvendt del Defibrillointisuojattu tyypin CF liityntäosa Defibrilleringssikker, pasientnær del av type CF Peça aplicada do tipo CF à prova de desfibrilhação On Activado Marche Acceso Ein Aan På Til Päällä På Ligado Off Desactivado Arrêt Spento Aus Uit Av Fra Pois päältä Av Desligado Equipotentiality Equipotencialidad Équipotentialité Equipotenzialità Potenzialgleichheit Equipotentiaal Ekvipotentialitet Ækvipotentialitet Tasapotentiaali Ekvipotensialitet Equipotencialidade

10 Page 10 Authorised Representative in the European Community Alarm, General Manufacturer Manufacturer and date of manufacture Authorised Representative in the European Community Representante autorizado en la Comunidad Europea Représentant agréé pour la Communauté européenne Rappresentante autorizzato nella Comunità Europea Autorisierte Vertretung in der Europäischen Gemeinschaft Gemachtigde vertegenwoordiger in de Europese Gemeenschap Auktoriserad representant i EU Autoriseret repræsentant i EU Valtuutettu edustaja Euroopan yhteisössä Autorisert representant i Det europeiske fellesskap Representante Autorizado na Comunidade Europeia Low priority alarm Alarma de prioridad baja Alarme priorité basse Allarme a bassa priorità Alarm geringer Priorität Alarm met lage prioriteit Larm av låg prioritet Lavprioritetsalarm Ei tärkeä hälytys Alarm med lav prioritet Alarme de prioridade baixa Manufacturer Fabricante Fabricant Produttore Hersteller Fabrikant Tillverkare Producent Valmistaja Produsent Fabricante Manufacturer and date of manufacture Fabricante y fecha de fabricación Fabricant et date de fabrication Produttore e data di produzione Hersteller und Herstellungsdatum Fabrikant en productiedatum Tillverkare och tillverkningsdatum Producent og produktionsdato Valmistaja ja valmistuspäivämäärä Produsent og produksjonsdato Fabricante e data de fabrico 1-8:2006:am1:2012 : Part 1-8: General requirements for basic safety and essential performance Colatteral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems

11 Page 11 Date of manufacture Date of manufacture Fecha de fabricación Date de fabrication Data di produzione Herstellungsdatum Productiedatum Tillverkningsdatum Fremstillingsdato Valmistuspäivämäärä Produksjonsdato Data de fabrico Not made with natural rubber latex No contiene látex de caucho natural Non fabriqué avec du latex de caoutchouc naturel Non prodotto con lattice di gomma naturale Ohne Naturkautschuk hergestellt Niet vervaardigd met natuurlijk rubberlatex Inte tillverkad med naturlig gummilatex Ikke fremstillet med naturgummilatex Ei sisällä luonnonkumilateksia Ikke laget med naturgummilateks Sem látex de borracha natural Applied Medical Resources Corporation. All rights reserved B

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