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Manual Well REF 89000

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  • Well REF 89000 - page 1

    REVOLUTION ® 45MHz ROT A TIONAL IMAGING CA THETER REF 89000 English Page 1 N e d e r l a n d s P a g e 4 Français Page 7 Deutsch Page 10 Italiano Page 13 Español Page 16 ...

  • Well REF 89000 - page 2

    1 REVOLUTION ENGLISH 45MHz ROTATIONAL IMAGING CATHETER CAUT ION: 1. U.S. Federal Law restricts this device to sale by or on the order of a physician. 2. Prior to use, read this entire Ins tructions For Use. INTENDED USE: The Revolution ® catheter is intended for the intravasc ular ultrasou nd examination of c oronary arteri es. Intravascula r ultr ...

  • Well REF 89000 - page 3

    2 INSTRUCTIONS FOR USE: Materials and Equipment Revolution Catheter Sterile PIM cover 10 in. extension tubing 3 cc and 10 cc syringes 3-way stop cock Pre-formed guide catheter [0.064 in. (1.63 mm) I.D. min.] with Y-adapter assembly* In-Vision Gold imaging system with software V5.0 or higher, Volcano s5 and Volcano s5i imaging system* Heparinized, p ...

  • Well REF 89000 - page 4

    3 LIMITE D WARRA NTY: Subject to the conditions and limitati ons on liability stated herein, Volcano Corporation (“VOLCANO”) warrants that the Revolution catheter (the “Catheter”), as so delivered, shall materially conform to VOLCANO’S then current specification for the Catheter upon receipt for a period of on e year from the date of deli ...

  • Well REF 89000 - page 5

    4 REVOLUTION NEDERLANDS 45MHz ROTERENDE IMAGINGKATHETER OPGELET: 1. Volgens de fed erale wetgeving van de VS mag dit product alleen door of op voorschrift van een arts worden verkocht. 2. Lees vóór gebruik deze volledige gebruiksaanw ijzing. BEOOGD GEBRUIK: De Revolution-katheter is bedoeld v oor gebruik bij intravasculaire echoscopie van kranssl ...

  • Well REF 89000 - page 6

    5 • De katheter bevat geen onderdelen die voor onderhoud door de gebruiker in aanmerking komen. Probeer geen onderdel en van de katheter te repa-reren of te wijzigen. • Probeer niet o m de katheter aan te sluiten op andere elektrische appara-tuur dan de hiervoor bestemde s ystemen. • Probeer de katheter nooit te bevestigen of los te koppelen ...

  • Well REF 89000 - page 7

    6 OPSLAG EN HANTERING: De producten moeten op een droge plaats worden bewaard waarbij de temperatuur in de oorspronkelijke kartonnen v erpakking niet boven 54 graden Celsius (54 ºC) uit mag komen. PRODUCTSPECIFICATIES: Model Revolution Catalogusnummer 89000 Diameter ter hoogte van transducer 3,2 F Maximale diameter voerdraad 0,36 mm (0,014") ...

  • Well REF 89000 - page 8

    7 R E V O L U T I O N FRANÇAIS CATHETER D’IMAGERIE IVUS ROTATOIRE DE 45 MHz ATTENTIO N : 1. En vertu de l a loi fédérale américain e, ce dispositif ne peut être vendu que par un médecin o u sur ordonnance médic ale. 2. Lire entièrement ce mode d’emploi avant to ut usage. INDICATIONS : L’utilisation du cathéter Revolution est indiqué ...

  • Well REF 89000 - page 9

    8 • Le cathéter ne comprend aucune pièce sur laquelle l’utilisateur peut intervenir. Ne tenter de réparer ou de modifier aucu n élément du cathéter. • Ne pas tenter de brancher le cathéter à d’autres équ ipements électroniques que les systèmes prévus à cet effet. • Ne jamais tenter d’attacher ou de détacher le cathéter lo ...

  • Well REF 89000 - page 10

    9 Diamètre maximal du guide 0,36 mm (0,014“) Cathéter-guide minimum 1,63 mm (6F) Longueur utile 135 cm Incertitude * +/- 29,1% ** +/- 14,6% TI : indice thermique défini par TI = W 01x1 f c 210 W 01x1 : sortie carré bornée (mW) f c : fréquence ce ntrale (MHz) MI : indice mécanique défini par MI= Pr.3/(f c 1/2 ) I SPPA.3 : intensité rédui ...

  • Well REF 89000 - page 11

    10 REVOLUTION D E U T S C H 45MHz-ROTATIONSKATHETER ZUR BILDGEBUNG VORSICHT: 1. Laut dem Bundesgesetz der U SA darf dieses Produkt nur von eine m Arzt oder auf Anweisung eines Arztes verkauft werden. 2. Vor Benutzung bitte diese Packungsbeila ge vollstän dig durc hl esen. VERWENDUNGSZWECK: Der Revolution-Katheter ist für die in travaskuläre Ultr ...

  • Well REF 89000 - page 12

    11 • Bei Wiederverwendung, Wiede raufbereitung oder Resterilisation besteht auch das Risiko einer Kontaminati on des Gerätes, und/oder es kann zur Infektion oder Kreuzinfektion des Patienten kommen, bei der unter anderem ansteckende Erkrankungen von einem Patienten auf den anderen übertragen werden können. Eine Kontamination des Geräts kann z ...

  • Well REF 89000 - page 13

    12 in die am meisten distal gelegene Positi on. Halten Sie den Draht in seiner Position und entfernen Sie den Katheter. Fehlerbehebun g Wenn das Systemmenü die Option „Rev olution-Katheter” nich t enthält, wenden Sie sich an Ihren Vertreter der Volcan o Corporation, bevor Sie fortfahren. Wenn die Bilder während des Gebrauchs blasser werden, ...

  • Well REF 89000 - page 14

    13 REVOLUTION ITALIANO CATETERE ROTATORIO PER IMAGING A 45 MHz ATTENZIO NE: 1. Le leggi federali statunite nsi limitano la vendita di questo dispositivo a personale medico o provvisto di a utorizzazione medica. 2. Prima dell’uso, leggere atte ntamente le presenti Istruzi oni per l’uso. USO PREVISTO: Il catetere Revolution è stato progettato pe ...

  • Well REF 89000 - page 15

    14 • Il catetere non include parti riparabili dall’utente. Non riparare né modificare alcun componente del catetere. • Non collegare il catetere ad apparecchiature elettroniche diverse dai sistemi specificati. • Non collegare né scollegare il catetere m entre l’interfaccia PIM è attivata. Tale operazione può danneggiare il connettore. ...

  • Well REF 89000 - page 16

    15 Catetere guida minimo 1,63 mm (6F) Lunghezza utile 135 cm Incertezza * +/- 29,1% ** +/- 14,6% TI : indice termico definito come TI = W 01x1 f c 210 W 01x1 : uscita quadrata limitata per la scansione (mW) f c : frequenza portante (MHz) MI : indice meccanico definito come MI= Pr.3/(f c 1/2 ) I SPPA.3 : intensità ridotta, media impulso di picco sp ...

  • Well REF 89000 - page 17

    16 REVOLUTION ESPAÑOL CATETER DE IMAGEN ROTACIONAL DE 45MHz AVI SO : 1. Las le yes federales de EE.UU. restringe n la venta de este producto a médicos o por orden fac ultativa. 2. Antes de usar el product o, lea estas Instruccio nes de uso en su totalidad. INDICACIONES DE USO: El catéter Revolution está previsto para la ecograf ía intravascula ...

  • Well REF 89000 - page 18

    17 • La reutilización, el reprocesami ento o la reesterilización también conlleva el riesgo de contaminación del dispositivo y puede provocar la infección del paciente o la infección cruzada incluida, entre otras, la transmisión de enfermedades infe cciosas entre pacientes. La contaminación del dispositivo puede ocasionar lesiones, enferm ...

  • Well REF 89000 - page 19

    18 ALMA CENAMI ENTO Y MA NIPULA CIÓN: Los productos deben almacenarse en un sitio seco a una temperatura que no supere los 54 grados centígrados (54 ÞC) en su caja original. ESPECIFICACIONES DEL PRODUCTO: Modelo Revolution Número de catálogo 89000 Perfil de cruce en el transductor 3,2F Guía máxima 0,36 mm (0,014") Catéter guía mínimo ...

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A complete manual for the device Well REF 89000, how should it look like?
A manual, also referred to as a user manual, or simply "instructions" is a technical document designed to assist in the use Well REF 89000 by users. Manuals are usually written by a technical writer, but in a language understandable to all users of Well REF 89000.

A complete Well manual, should contain several basic components. Some of them are less important, such as: cover / title page or copyright page. However, the remaining part should provide us with information that is important from the point of view of the user.

1. Preface and tips on how to use the manual Well REF 89000 - At the beginning of each manual we should find clues about how to use the guidelines. It should include information about the location of the Contents of the Well REF 89000, FAQ or common problems, i.e. places that are most often searched by users in each manual
2. Contents - index of all tips concerning the Well REF 89000, that we can find in the current document
3. Tips how to use the basic functions of the device Well REF 89000 - which should help us in our first steps of using Well REF 89000
4. Troubleshooting - systematic sequence of activities that will help us diagnose and subsequently solve the most important problems with Well REF 89000
5. FAQ - Frequently Asked Questions
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