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baxter prismaflex TPE1000 SET Notice D'utilisation

baxter prismaflex TPE1000 SET Notice D'utilisation

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BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014992
Designer: CDS
Colour Reference:
BLACK
TPE1000 SET / TPE2000 SET
Date: 02-NOV-2020
Proofread No.: 1
Page: 1 of 80
Instructions for use
Notice d'utilisation
Gebrauchsanweisung
Instrucciones de Uso
Istruzioni per l'uso
Bruksanvisning
Gebruiksaanwijzing
Instruções de uso
Bruksanvisning
Brugsanvisning
Käyttöohje
Instrukcja stosowania
Kullanma talimatları
Инструкция по применению
Návod k použití
Οδηγίες χρήσης
Használati utasítás
Инструкции за употреба
Uputstvo za upotrebu
Instrucțiuni de utilizare
Kasutusjuhend
Naudojimo instrukcijos
Lietošanas instrukcija
Інструкція з використання
Hướng dẫn sử dụng
Petunjuk penggunaan
Made in France
Date of Revision: 2020-11-01
107143
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  • Page 1 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 1 of 80 Colour Reference: BLACK TPE1000 SET / TPE2000 SET Instructions for use Notice d‘utilisation Gebrauchsanweisung Instrucciones de Uso Istruzioni per l'uso...
  • Page 2 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 2 of 80 Colour Reference: BLACK Blood warmer connection (blue) Connexion réchauffeur sang (bleue) Blutwärmeranschluss (blau) Blood warmer connection (blue) Conexión del calentador de sangre (azul) Connexion réchaffeur sang (bleue)

  • Page 3: Definition Of Symbols

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 3 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS ENGLISH FRANÇAIS DEUTSCH SYMBOL GRAPHIC TITLE AND NUMBER & REF NUM / OF STANDARD / SYMBOLES TITRE ET NUMÉRO...
  • Page 4 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 4 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS ESPAÑOL ITALIANO SVENSKA GRÁFICO Y N.º REF. / TÍTULO Y NÚMERO SIMBOLO GRAFICO E DE NORMA / N.
  • Page 5 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 5 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS NEDERLANDS PORTUGUÊS NORSK SYMBOOLWEERGAVE TITEL EN NUMMER EN REF.NR. / VAN RICHTLIJN / SÍMBOLO GRÁFICO TÍTULO E NÚMERO...
  • Page 6 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 6 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS DANSK SUOMI TITEL OG NUMMER SYMBOLGRAFIK OG PÅ STANDARD / BESKRIVELSE AF SYMBOL REF.NR. / SYMBOLIN...
  • Page 7 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 7 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS POLSKI TÜRKÇE ZNAK GRAFICZNY SYMBOLU I NUMER TYTUŁ I NUMER NAZWA REFERENCYJNY / NORMY / STANDART OPIS SYMBOLU (TEKST OBJAŚNIENIA)
  • Page 8 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 8 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS ČESKY РУССКИЙ ИЗОБРАЖЕНИЕ НАЗВАНИЕ СИМВОЛА И И НОМЕР СТАНДАРТА / ИСХОДНЫЙ НАЗВАНИЕ ОПИСАНИЕ СИМВОЛА...
  • Page 9 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 9 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS ΕΛΛΗΝΙΚΑ MAGYAR БЪЛГАРСКИ ΕΙΚΟΝΑ ΣΥΜΒΟΛΟΥ ΤΙΤΛΟΣ ΚΑΙ ΚΑΙ ΑΡΙΘΜΟΣ ΑΡΙΘΜΟΣ ΑΝΑΦΟΡΑΣ ΠΡΟΤΥΠΟΥ / ΠΕΡΙΓΡΑΦΗ ΣΥΜΒΟΛΩΝ...
  • Page 10 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 10 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS SRPSKI ROMÂNĂ EESTI KEEL NAZIV I BROJ PRIKAZ SIMBOLA STANDARDA I REF. BROJ / / DENUMIRE GRAFICĂ...
  • Page 11 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 11 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS LIETUVIŲ K. LATVISKI GRAFINIS SIMBOLIS STANDARTO IR ŠALTINIO PAVADINIMAS NUMERIS / SIMBOLA IR NUMERIS / SIMBOLIO APRAŠAS (AIŠKINAMASIS...
  • Page 12 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 12 of 80 Colour Reference: BLACK DEFINITION OF SYMBOLS УКРАЇНСЬКА TIẾNG VIỆT BAHASA INDONESIA ГРАФІЧНІ СИМВОЛИ НАЗВА ТА НОМЕР ТА ВИХІДНІ НОМЕРИ СТАНДАРТУ / / BIỂU TƯỢNG ĐỒ...

  • Page 13: Table Des Matières

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 13 of 80 Colour Reference: BLACK English ..........14 Français ..........16 Deutsch ..........18 Español ..........20 Italiano ..........22 Svenska ..........24 Nederlands ..........26 Português ..........28 Norsk ...........30 Dansk ..........32...

  • Page 14: English

    The use of the Prismaflex TPE1000 set should be restricted to patients with a 11. In the case of patients who pose a high risk of hemorrhage it is recommended body weight greater than 9kgs (20lbs).
  • Page 15 69883 MEYZIEU CEDEX, FRANCE. INSTRUCTIONS FOR USE Philippines: Baxter Healthcare Philippines Inc., Silangan Industrial Estate, Brgy. Canlubang, Note: use the set by following the detailed on-line instructions provided by the Calamba City, Laguna, Philippines control unit. Additional information is available in the control unit operator’s MDR-07360 manual.

  • Page 16: Français

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 16 of 80 Colour Reference: BLACK FRANÇAIS AVERTISSEMENTS ET PRÉCAUTIONS Le set Prismaflex TPE1000/TPE2000 est fabriqué par GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCE.

  • Page 17: Matériaux Du Set

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 17 of 80 Colour Reference: BLACK PROCÉDURES SPÉCIALES EN CAS DE 16. Une fuite externe de sang risque de ne pas être immédiatement identifiée par l'équipement de surveillance et peut entraîner une perte significative de...

  • Page 18: Deutsch

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 18 of 80 Colour Reference: BLACK DEUTSCH VORSICHTSMAßNAHMEN und WARNHINWEISE Das Prismaflex TPE1000/TPE2000-Set wird von GAMBRO Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANKREICH hergestellt.

  • Page 19: Technische Daten

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 19 of 80 Colour Reference: BLACK BESONDERE VORGEHENSWEISEN BEI 17. Um Komplikationen aufgrund der Blutviskosität zu vermeiden, sollte der Post- Filter-Hämatokritwert (Hämatokrit im Blutrückfluss des Patienten) niemals 65 KOMPLIKATIONEN % übersteigen.

  • Page 20: Español

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 20 of 80 Colour Reference: BLACK ESPAÑOL PRECAUCIONES Y ADVERTENCIAS El set Prismaflex TPE1000/TPE2000 está fabricado por GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCIA.
  • Page 21 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 21 of 80 Colour Reference: BLACK 19. Una publicación de referencia* y los datos de laboratorio han revelado un Reacciones de hipersensibilidad aumento en la caída de presión del filtro plasmático con el tiempo cuando Nota: Consulte la advertencia n.º...

  • Page 22: Italiano

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 22 of 80 Colour Reference: BLACK ITALIANO AVVISI DI ATTENZIONE E AVVERTENZE Il set Prismaflex TPE1000/TPE2000 è prodotto da GAMBRO Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCIA.
  • Page 23 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 23 of 80 Colour Reference: BLACK PROCEDURE SPECIALI IN CASO DI 17. Per evitare complicanze dovute all'aumento della viscosità del sangue, l'ematocrito post-riempimento (ematocrito nel rientro ematico del paziente) COMPLICANZE non deve superare il 65%.

  • Page 24: Svenska

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 24 of 80 Colour Reference: BLACK SVENSKA FÖRSIKTIGHETSÅTGÄRDER OCH VARNINGAR Prismaflex-setet TPE1000/TPE2000 är tillverkat av GAMBRO Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANKRIKE.

  • Page 25: Specifikationer

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 25 of 80 Colour Reference: BLACK 18. I vissa fall kan hemolys förekomma (rosa eller röd färgton i avflödespåsen) men kanske inte identifieras genom larm av kontrollenheten. När du utför SPECIALRUTINER I HÄNDELSE AV...

  • Page 26: Nederlands

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 26 of 80 Colour Reference: BLACK NEDERLANDS De Prismaflex TPE1000/TPE2000-set wordt vervaardigd door GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANKRIJK.

  • Page 27: Specificaties

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 27 of 80 Colour Reference: BLACK GEBRUIKSAANWIJZING 13. Gebruik deze set alleen wanneer de besturingseenheid zich in de TPE-modus bevindt. Het gebruik van deze set met CRRT-therapie kan leiden tot letsel of de Opmerking: gebruik de set op basis van de uitvoerige online-instructies van de dood.

  • Page 28: Português

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 28 of 80 Colour Reference: BLACK PORTUGUÊS PRECAUÇÕES E ADVERTÊNCIAS O set Prismaflex TPE1000/TPE2000 é fabricado pela GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANÇA Observação: consulte a interface do utilizador e o manual do operador da...

  • Page 29: Especificações

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 29 of 80 Colour Reference: BLACK PROCEDIMENTOS ESPECIAIS EM CASO DE 16. Fugas externas de sangue podem não ser identificadas imediatamente pelo equipamento de monitorização e podem resultar em perda significativa de COMPLICAÇÃO...

  • Page 30: Produktbeskrivelse

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 30 of 80 Colour Reference: BLACK OBSERVER-VARSLER OG ADVARSLER Prismaflex TPE1000/TPE2000-settet er produsert av GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANKRIKE.

  • Page 31: Spesifikasjoner

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 31 of 80 Colour Reference: BLACK 19. Referanselitteratur* og laboratoriedata har vist at trykkfallet i plasmafilteret Hemolyse øker over tid når nivået av antikoagulasjon (heparin) ikke er tilstrekkelig. I slike Merk: Se advarsel 18 og 19.

  • Page 32: Dansk

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 32 of 80 Colour Reference: BLACK DANSK FORSIGTIGHEDSANVISNINGER OG Prismaflex TPE1000/TPE2000-sættet er produceret af GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANKRIG.
  • Page 33 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 33 of 80 Colour Reference: BLACK 19. Referencelitteratur* og laboratoriedata har vist en stigning i plasmafilter- Den ordinerende læge skal derfor være særligt opmærksom på patienter, trykfaldet over tid, når antikoagulationsniveauet (heparin) er utilstrækkeligt.

  • Page 34: Suomi

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 34 of 80 Colour Reference: BLACK SUOMI HUOMIOT JA VAROITUKSET Prismaflex TPE1000/TPE2000 -settiä valmistaa GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, RANSKA Huomautus: katso lisätietoja huomioista ja varoituksista ohjausyksikön...

  • Page 35: Tekniset Tiedot

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 35 of 80 Colour Reference: BLACK 20. Hävitä setti yhden käyttökerran jälkeen käyttäen aseptista tekniikkaa ja Hemolyysi mahdollisesti kontaminoituneen materiaalin hävitysmenetelmiä. Älä sterilisoi Huomautus: katso varoitukset 18 ja 19.

  • Page 36: Polski

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 36 of 80 Colour Reference: BLACK POLSKI Zestaw Prismaflex TPE1000/TPE2000 jest wytwarzany przez firmę GAMBRO PRZESTROGI I OSTRZEŻENIA Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCJA.

  • Page 37: Gwarancja I Ograniczenie Odpowiedzialności

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 37 of 80 Colour Reference: BLACK SPECJALNE PROCEDURY W PRZYPADKU 17. W celu uniknięcia powikłań związanych ze zwiększoną lepkością krwi hematokryt za filtrem (hematokryt krwi zwracanej pacjentowi) nigdy nie POWIKŁAŃ...

  • Page 38: Türkçe

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 38 of 80 Colour Reference: BLACK TÜRKÇE İKAZLAR VE UYARILAR Prismaflex TPE1000/TPE2000 seti, GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANSA tarafından üretilmiştir.

  • Page 39: Kullanma Tali̇matlari

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 39 of 80 Colour Reference: BLACK Hemoliz 20. Kullanımdan sonra, potansiyel olarak kontamine olmuş ekipmanlara yönelik aseptik tekniği kullanarak bu seti imha edin. Sterilize etmeyin. Prismaflex TPE Not: 18 ve 19 numaralı...

  • Page 40: Русский

    Во время заполнения и эксплуатации внимательно следите за стыками в показано удаление компонентов плазмы. устройстве и соединениями с другими утвержденными принадлежностями и Prismaflex TPE1000 set можно применять, только если масса тела пациента пакетами для исключения утечки. Утечка может стать причиной кровопотери, превышает 9 кг (20 фунтов).

  • Page 41: Технические Характеристики

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 41 of 80 Colour Reference: BLACK 17. Во избежание осложнений, связанных с повышением вязкости крови, Техническое обслуживание и ремонт гематокрит после фильтра (гематокрит в магистрали возврата крови пациенту) Техническое...

  • Page 42: Český

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 42 of 80 Colour Reference: BLACK ČESKY Soupravu Prismaflex TPE1000/TPE2000 vyrábí společnost GAMBRO Není-li pacient připojen k soupravě Prismaflex okamžitě po dokončení plnění...
  • Page 43 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 43 of 80 Colour Reference: BLACK SPECIFIKACE ZÁRUKA A OMEZENÍ ODPOVĚDNOSTI Viz tabulky na konci dokumentu. Výrobce zaručuje, že souprava Prismaflex byla vyrobena v souladu s jejími technickými údaji a se zásadami správné...

  • Page 44: Ελληνικά

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 44 of 80 Colour Reference: BLACK ΕΛΛΗΝΙΚΑ ΣΥΣΤΑΣΕΙΣ ΠΡΟΣΟΧΗΣ ΚΑΙ ΠΡΟΕΙΔΟΠΟΙΗΣΕΙΣ Το σετ Prismaflex TPE1000/TPE2000 κατασκευάζεται από την GAMBRO Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, ΓΑΛΛΙΑ.

  • Page 45: Οδηγιεσ Χρησησ

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 45 of 80 Colour Reference: BLACK ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ Prismaflex . Η χρήση μεγαλύτερων βελονών μπορεί να δημιουργήσει οπές στα σημεία δειγμάτων, με αποτέλεσμα τις εξωτερικές διαρροές ή την είσοδο...
  • Page 46 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 46 of 80 Colour Reference: BLACK γ) Ο κατασκευαστής δεν φέρει καμία ευθύνη για τυχόν εσφαλμένη χρήση, ακατάλληλο χειρισμό, μη συμμόρφωση με τις προειδοποιήσεις και τις οδηγίες, ζημιά...

  • Page 47: Magyar

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 47 of 80 Colour Reference: BLACK MAGYAR FIGYELMEZTETÉSEK ÉS VESZÉLYJELZÉSEK A Prismaflex TPE1000/TPE2000 szerelék gyártója: GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCIAORSZÁG.

  • Page 48: Műszaki Adatok

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 48 of 80 Colour Reference: BLACK KÜLÖNLEGES ELJÁRÁSOK KOMPLIKÁCIÓ 18. Néhány esetben hemolízis történhet (rózsaszínes vagy pirosas árnyalat a kifolyózsákban), amit a vezérlőegység nem érzékel és nem jelzi riasztással.

  • Page 49: Български

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 49 of 80 Colour Reference: BLACK БЪЛГАРСКИ ВНИМАНИЕ И ПРЕДУПРЕЖДЕНИЕ Комплектът Prismaflex TPE1000/TPE2000 се произвежда от GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, Забележка: направете...
  • Page 50 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 50 of 80 Colour Reference: BLACK СПЕЦИАЛНИ ПРОЦЕДУРИ В СЛУЧАЙ НА 18. В някои случаи може да настъпи хемолиза (розов или червен оттенък в...

  • Page 51: Srpski

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 51 of 80 Colour Reference: BLACK SRPSKI Set Prismaflex TPE1000/TPE2000 proizvodi kompanija GAMBRO Industries, Ako pacijent ne bude povezan sa setom Prismaflex odmah nakon završenog ispiranja, isperite set sa najmanje 1000 ml rastvora za ispiranje [fiziološki ili...
  • Page 52 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 52 of 80 Colour Reference: BLACK Hemoliza 21. Koristite samo lekove kompatibilne sa plastikom navedenom u odeljku sa specifikacijama. Neke vrste plastike mogu da budu nekompatibilne sa lekovima Napomena: pogledajte upozorenja br.

  • Page 53: Română

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 53 of 80 Colour Reference: BLACK ROMÂNĂ PRECAUȚII ȘI AVERTISMENTE Setul Prismaflex TPE1000/TPE2000 este fabricat de GAMBRO Industries, 7 Avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANȚA.

  • Page 54: Instrucțiuni De Utilizare

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 54 of 80 Colour Reference: BLACK 19. Bibliografia de referință* și datele de laborator au arătat o creștere în timp a Dacă apar reacții alergice acute (sindrom la prima utilizare) în primele minute scăderilor de presiune la nivelul filtrului pentru plasmă...

  • Page 55: Eesti Keel

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 55 of 80 Colour Reference: BLACK EESTI KEEL ETTEVAATUSABINÕUD JA HOIATUSED Komplekti Prismaflex TPE1000/TPE2000 on tootnud ettevõte GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, PRANTSUSMAA.
  • Page 56 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 56 of 80 Colour Reference: BLACK 20. Hävitage komplekt pärast ühekordset kasutamist, kasutades TPE-ravi ajal esineb risk hemolüüsiks tulenevalt membraani pooride suhtelisest potentsiaalselt saastunud seadmete aseptilist tehnikat. Mitte re-steriliseerida.

  • Page 57: Lietuvių K

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 57 of 80 Colour Reference: BLACK LIETUVIŲ K. „Prismaflex TPE1000/TPE2000“ rinkinio gamintojas „GAMBRO Industries“, 7 Jei pacientas neprijungiamas prie „Prismaflex“ rinkinio iškart po to, kai pabaigiamas užpildymas, prieš...
  • Page 58 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 58 of 80 Colour Reference: BLACK SPECIFIKACIJOS GARANTIJA IR ĮSIPAREIGOJIMŲ APRIBOJIMAS Žr. lenteles dokumento gale. Gamintojas garantuoja, kad „Prismaflex“ rinkinys buvo pagamintas pagal jo specifikacijas ir atitinka geros gamybos praktikos reikalavimus, kitus taikomus pramonės standartus ir reguliavimo reikalavimus.

  • Page 59: Latviski

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 59 of 80 Colour Reference: BLACK LATVISKI Komplekta Prismaflex TPE1000/TPE2000 ražotājs ir GAMBRO Industries, 7 Avenue Ja Prismaflex komplekts netiek pievienots pacientam uzreiz pēc uzpildes pabeigšanas, pirms pievienošanas pacientam izskalojiet komplektu ar vismaz...
  • Page 60 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 60 of 80 Colour Reference: BLACK 21. Izmantojiet tikai tādus medikamentus, kas ir saderīgi ar specifikāciju sadaļā Lēna asins plūsma un liels aizvietošanas plūsmas ātrums (un vai liels pacienta norādītajiem plastmasas materiāliem.

  • Page 61: Українська

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 61 of 80 Colour Reference: BLACK УКРАЇНСЬКА ЗАСТЕРЕЖЕННЯ ТА ПОПЕРЕДЖЕННЯ Комплекти Prismaflex для терапевтичного плазмообміну TPE1000/TPE2000 (далі комплект Prismaflex) виробляється компанією Гамбро Індастріс...

  • Page 62: Гарантія Та Обмеження Відповідальності

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 62 of 80 Colour Reference: BLACK 16. Зовнішні витікання крові можуть не відразу виявлятись обладнанням для Підвісьте пакет із заповнюючим розчином (фізіологічним розчином або лужним...

  • Page 63: Tiếng Việt

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 63 of 80 Colour Reference: BLACK TIẾNG VIỆT THẬN TRỌNG VÀ CẢNH BÁO Bộ quả lọc trao đổi huyết tương Prismaflex TPE1000/TPE2000 được sản xuất bởi GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, PHÁP.

  • Page 64: Thông Số Kỹ Thuật

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 64 of 80 Colour Reference: BLACK Tan máu 20. Tiêu hủy bộ quả lọc này sau một lần sử dụng, sử dụng kỹ thuật vô trùng cho các thiết bị...

  • Page 65: Bahasa Indonesia

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 65 of 80 Colour Reference: BLACK BAHASA INDONESIA PERHATIAN DAN PERINGATAN Set Prismaflex TPE1000/TPE2000 diproduksi oleh GAMBRO Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, PRANCIS.

  • Page 66: Petunjuk Penggunaan

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 66 of 80 Colour Reference: BLACK 19. Literatur referensi* dan data laboratorium telah menunjukkan peningkatan Jika kebocoran darah eksternal diamati, segera hentikan pompa darah. Mulai...
  • Page 67 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 67 of 80 Colour Reference: BLACK TRANSLATIONS ENGLISH FRANÇAIS DEUTSCH ESPAÑOL PHYSICAL CHARACTERISTICS CARACTÉRISTIQUES PHYSIQUES ÄUẞERE MERKMALE CARACTERÍSTICAS FÍSICAS Membrane effective surface area Surface effective de la membrane Wirksame Filteroberfläche der...
  • Page 68 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 68 of 80 Colour Reference: BLACK ITALIANO SVENSKA NEDERLANDS PORTUGUÊS CARATTERISTICHE FISICHE FYSISKA EGENSKAPER FYSIEKE KENMERKEN CARACTERÍSTICAS FÍSICAS Superficie filtro effettiva della Membranets effektiva ytarea Fibrernas Effectieve oppervlakte membraan Área de superfície efetiva da membrana...
  • Page 69 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 69 of 80 Colour Reference: BLACK NORSK DANSK SUOMI POLSKI FYSISKE EGENSKAPER FYSISKE KARAKTERISTIKA FYYSISET OMINAISUUDET CHARAKTERYSTYKA FIZYCZNA Effektivt overflateområde for Membraneffektivt overfladeareal Kalvon tehokas pinta-ala Kuitujen Efektywna powierzchnia błony...
  • Page 70 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 70 of 80 Colour Reference: BLACK TÜRKÇE РУССКИЙ ČEŠTINA ΕΛΛΗΝΙΚΑ FİZİKSEL ÖZELLİKLER ФИЗИЧЕСКИЕ ХАРАКТЕРИСТИКИ FYZIKÁLNÍ CHARAKTERISTIKY ΦΥΣΙΚΑ ΧΑΡΑΚΤΗΡΙΣΤΙΚΑ Membran etkin yüzey alanı Fiber iç çapı...
  • Page 71 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 71 of 80 Colour Reference: BLACK MAGYAR БЪЛГАРСКИ SRPSKI ROMÂNĂ FIZIKAI JELLEMZŐK ФИЗИЧЕСКИ ХАРАКТЕРИСТИКИ FIZIČKE KARAKTERISTIKE CARACTERISTICI FIZICE Membrán effektív felszín Szál belső...
  • Page 72 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 72 of 80 Colour Reference: BLACK EESTI LIETUVIŲ K. LATVISKI УКРАЇНСЬКА FÜÜSIKALISED OMADUSED FIZINĖS CHARAKTERISTIKOS FIZIKĀLĀS ĪPAŠĪBAS ФІЗИЧНІ ХАРАКТЕРИСТИКИ Membraani efektiivne pindala Membranos efektyvusis paviršiaus Membrānas lietderīgā...

  • Page 73: Bahasa Indonesia

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 73 of 80 Colour Reference: BLACK TIẾNG VIỆT BAHASA INDONESIA ĐẶC TÍNH VẬT LÝ KARAKTERISTIK FISIK Diện tích bề mặt hiệu dụng của màng Luas permukaan efektif membran Kích thước trong của sợi (ướt)

  • Page 74: Physical Characteristics

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 74 of 80 Colour Reference: BLACK PRISMAFLEX TPE 1000 set TPE 2000 set PHYSICAL CHARACTERISTICS (1) Membrane effective surface area 0.15 m² 0.35 m²...
  • Page 75 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 75 of 80 Colour Reference: BLACK Prismatherm SP420 line connection...
  • Page 76 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 76 of 80 Colour Reference: BLACK...
  • Page 77 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 77 of 80 Colour Reference: BLACK...
  • Page 78 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 78 of 80 Colour Reference: BLACK THIS PAGE HAS BEEN LEFT DELIBERATELY BLANK...
  • Page 79 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 79 of 80 Colour Reference: BLACK THIS PAGE HAS BEEN LEFT DELIBERATELY BLANK...
  • Page 80 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 1000014992 Date: 02-NOV-2020 Proofread No.: 1 Designer: CDS Page: 80 of 80 Colour Reference: BLACK Baxter, Prismaflex, Prismatherm and Prismax are trademarks of Baxter International Inc. or its subsidiaries.

Ce manuel est également adapté pour:

Prismaflex tpe2000 set

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