Urologix Prostiva 8099 User manual

PROSTIVA®RF THERAPY
0° Telescope 8099
15° Telescope 8099TU15
Téléscope à 0° 8099
Téléscope à 15° 8099TU15
0°-Teleskop 8099
15°-Teleskop 8099TU15
Endoscopio a 0° Modelo 8099
Endoscopio a 15°
Modelo 8099TU15
0°-telescoop 8099
15°-telescoop 8099TU15
Ottica endoscopica a 0°
modello 8099
Ottica endoscopica a 15°
modello 8099TU15
0° teleskooppi 8099
15° teleskooppi 8099TU15
0°-behandlingsoptik 8099
15°-behandlingsoptik
8099TU15
Τηλεσκόπιο 0° 8099
Τηλεσκόπιο 15° 8099TU15
0° behandlingsteleskop 8099
15° behandlingsteleskop
8099TU15
Endoscópio 0° 8099
Endoscópio 15° 8099TU15
Instructions For Use ■Mode
d’emploi ■Bedienungsanleitung
Instrucciones de uso
Gebruiksaanwijzing ■Istruzioni
per l’uso ■Käyttöohjeet
Bruksanvisning ■Οδηγίες
χρήσης ■Brugsanvisning
Instruções de utilização
Rx only

3
Catalog number / Numéro de
catalogue / Katalognummer / N.º de
catálogo / Catalogusnummer /
Numero di catalogo / Luettelonumero
/ Katalognummer / Αριθμός
καταλόγου / Katalognummer /
Número de catálogo
Serial number / Numéro de série /
Seriennummer / Número de serie /
Serienummer / Numero di serie /
Sarjanumero / Serienummer /
Αριθμός σειράς / Serienummer /
Número de série
Non-sterile / Non stérile / Nichtsteril /
No estéril / Niet-steriel / Non sterile /
Epästeriili / Icke-steril / Μη στείρο /
Ikke-steril / Não estéril
Quantity / Quantité / Menge /
Cantidad / Aantal / Quantità /
Määrä / Mängd / Ποσότητα / Antal /
Quantidade
Temperature limitation / Limite de
température / Temperaturbereich /
Limitación de la temperatura /
Temperatuurbereik / Limiti di
temperatura / Lämpötilaraja-arvot /
Temperaturbegränsning / Όρια
θερμοκρασίας /
Temperaturbegrænsning / Limite de
temperatura
For USA audiences only / Ne
s’applique qu’aux États-Unis / Gilt
nur für Leser in den USA / Sólo
aplicable en EE.UU. / Alleen van
toepassing voor de VS /
Esclusivamente per il mercato
statunitense / Koskee vain
Yhdysvaltoja / Gäller endast i USA /
Μόνο για πελάτες εντός των ΗΠΑ /
Gælder kun i USA / Apenas aplicável
aos E.U.A.
Caution, consult accompanying
documents / Attention, se référer aux
documents joints / Achtung, siehe
Begleitdokumentation / Precaución,
consulte los documentos que se
incluyen / Let op: Zie bijgevoegde
documentatie / Attenzione, vedere i
documenti allegati / Huomio: Katso
oheiset asiakirjat / OBS! Se
medföljande dokument / Προσοχή,
συμβουλευτείτε τα συνοδευτικά
έγγραφα / Forsigtig! Se medfølgende
dokumentation / Atenção, consulte
os documentos anexos
Consult instructions for use /
Consulter le mode d’emploi /
Gebrauchsanweisung lesen /
Consultar instrucciones de uso /
Raadpleeg de gebruiksaanwijzing /
Fare riferimento alle istruzioni per
l’uso / Katso käyttöohjeet / Läs
bruksanvisningen / Συμβουλευτείτε
τις οδηγίες χρήσης / Se
brugsanvisningen / Consulte as
instruções de utilização
Manufacturer / Fabricant /
Hersteller / Fabricante / Fabrikant /
Produttore / Valmistaja / Tillverkare /
Κατασκευαστής / Fabrikant /
Fabricante
XXX °F
XX °C
-XX °F
-XX °C

4
Authorized representative in the
European community / Représentant
agréé dans la communauté
européenne / Autorisierte Vertretung
für das Gebiet der Europäischen
Union / Representante autorizado en
la Comunidad Europea /
Geautoriseerd vertegenwoordiger in
de Europese Unie / Rappresentante
autorizzato nella Comunità
Europea / Valtuutettu edustaja
Euroopan yhteisön alueella /
Auktoriserad representant inom EG /
Εξουσιοδοτημένος αντιπρόσωπος
στην Ευρωπαϊκή Κοινότητα /
Autoriseret EU-repræsentant /
Representante autorizado na União
Europeia
Conformité Européenne (European
Conformity). This symbol means that
the device fully complies with
European Directive MDD
93/42/EEC. / Conformité
Européenne. Ce symbole signifie
que l’appareil est entièrement
conforme à la Directive Européenne
MDD 93/42/CEE. / Conformité
Européenne (Europäische
Konformität) Dieses Symbol besagt,
dass das Gerät allen Vorschriften
der europäischen Direktive MDD
(93/42/EWG) entspricht. /
Conformité Européenne
(Conformidad Europea). Este
símbolo indica que el dispositivo
cumple totalmente la
Directiva Europea 93/42/CEE
relativa a los productos sanitarios. /
Conformité Européenne
(Europese Conformiteit).
Dit symbool betekent dat het
apparaat volledig voldoet aan de
Europese Richtlijn
MDD 93/42/EEG. / Conformité
Européenne (Conformità Europea).
Questo simbolo significa che il
dispositivo è conforme alla Direttiva
Europea MDD 93/42/CEE. /
Conformité Européenne
(eurooppalainen
vaatimustenmukaisuus). Tämä
symboli tarkoittaa, että laite on
kaikilta osin EU:n lääkintälaitedirektiivin
93/42/ETY mukainen. / Conformité
Européenne (EU-standard). Denna
symbol betyder att enheten helt följer
EU-direktiv 93/42/EEG om
medicintekniska produkter. /
Conformité Européenne (Eυρωπαϊκή
Συμμόρφωση). Το σύμβολο αυτό
σημαίνει ότι ησυσκευή
συμμορφώνεται πλήρως με την
Ευρωπαïκή Οδηγία 93/42/ΕΟΚ περί
ιατροτεχνολογικών προϊόντων. /
Conformité Européenne (Europæisk
Standard). Dette symbol betyder, at
enheden fuldt ud overholder
EU-direktiv MDD 93/42/EØF. /
Conformité Européenne
(Conformidade Europeia). Este
símbolo significa que o dispositivo
está em total conformidade com a
Directiva Europeia MDD 93/42/CEE.
EC REP
0086

5
Urologix and Prostiva are registered
trademarks of Urologix, Inc.
Sterrad and Enzol are registered
trademarks of Johnson & Johnson Corp.
Urologix et Prostiva sont des marques
déposées de Urologix, Inc.
Sterrad et Enzol sont des marques
déposées de Johnson & Johnson Corp.
Urologix und Prostiva sind eingetragene
Marken von Urologix, Inc.
Sterrad und Enzol sind eingetragene
Markenn von Johnson & Johnson Corp.
Urologix y Prostiva son marcas
comerciales registradas de
Urologix, Inc.
Sterrad y Enzol son marcas comerciales
registradas de Johnson & Johnson Corp.
Urologix en Prostiva zijn geregistreerde
handelsmerken van Urologix, Inc.
Sterrad en Enzol zijn gedeponeerde
handelsmerken van Johnson & Johnson
Corp.
Urologix e Prostiva sono marchi
registrati della Urologix, Inc.
Sterrad ed Enzol sono marchi registrati di
Johnson & Johnson Corp.
Urologix ja Prostiva ovat Urologix, Inc:n
rekisteröityjä tavaramerkkejä.
Sterrad ja Enzol ovat Johnson & Johnson
Corp.-yhtiön rekisteröityjä
tavaramerkkejä.
Urologix och Prostiva är registrerade
varumärken som tillhör Urologix, Inc.
Sterrad och Enzol är registrerade
varumärken som tillhör Johnson &
Johnson Corp.
Τα Urologix και Prostiva είναι σήματα
κατατεθέντα της Urologix, Inc.
Οι επωνυμίες Sterrad και Enzol είναι
σήματα κατατεθέντα της Johnson &
Johnson Corp.
Urologix og Prostiva er registrerede
varemærker tilhørende Urologix, Inc.
Sterrad og Enzol er registrerede
varemærker tilhørende Johnson &
Johnson Corp.
Urologix e Prostiva são marcas
comerciais registadas da
Urologix, Inc.
Sterrad e Enzol são marcas comerciais
registadas da Johnson & Johnson Corp.

6

7
English ...............................................9
Français ...........................................19
Deutsch............................................29
Español............................................39
Nederlands.......................................49
Italiano .............................................57
Suomi...............................................67
Svenska ...........................................75
Ελληνικά ..........................................83
Dansk...............................................93
Português.......................................101

8

8099/8099TU15 2012-11 English 9
Prostiva RF Therapy
Telescope
Introduction
The instructions below describe the
general procedure for safe handling of
the Prostiva RF Therapy Telescopes.
The telescope is a reusable device.
Before you use the telescope and for
each subsequent use, it must be
cleaned, decontaminated, and
sterilized. These instructions are
designed to assist you in cleaning,
sterilizing, caring for, and storing your
telescopes. Please read them carefully.
By following these instructions, your
telescopes will provide you with a long
service life.
Indications for Use
The telescope is used to position the
Model 8929 Prostiva RF Hand Piece
through the urethra into the prostate.
This telescope shall only be used in
conjunction with the Prostiva Hand
Piece.
Safety Information
For a list of contraindications, warnings,
precautions and adverse events refer to
the Prostiva RF Therapy System User
Guide.
Instructions for Use
Inspection
Upon receipt, immediately inspect the
telescope for signs of damage. Also
inspect the Prostiva RF Therapy
Telescope before and after every
procedure. Dents along the shaft and
scratches on the lens are the most
noticeable signs of damage. Look
through and rotate the telescope to
check the clarity of the view. Scratches,
fingerprints and debris will cause an
impaired view. Additionally, debris may
act as an abrasive and scratch the lens.
To make certain a telescope is in good
working order, observe the reflected
light on the surfaces of the ocular and
objective lenses. These surfaces should
be smooth and shiny.
Inspect the integrity of the fiber optics
by holding the light post towards a light
and observing the distal tip. The fiber
optics are intact when the light is evenly
distributed. Darkened areas indicate
broken fibers. Foggy images may result
from moisture entering a damaged seal
around the lens. A partially or
completely obstructed view may be the
result of damaged lenses within the

10 English 2012-11 8099/8099TU15
telescope shaft or eyepiece. Do not use
a telescope that shows signs of
damage.
If it is necessary to dispose of the
telescope, discard in accordance with
local environmental regulations.
For assembly, installation and
connection instructions, refer to the
Prostiva RF Therapy System User
Guide.
Handling
The Prostiva RF Therapy Telescope
consists of an eyepiece with glass
ocular lens, a fiber optic light cable
connection with screw-on type cable
connectors to accept several
manufacturers’ light cables, and a
stainless steel shaft containing the rod
lens system and objective lens.
As with all optical instruments, the
telescope is a very delicate piece of
endoscopic equipment. To ensure the
long-lasting quality of the telescope,
please follow the handling instruction
described below.
■To prevent breakage, the telescope
should be supported by firmly
grasping the eyepiece end. Never
handle by the distal end alone.
■Never bend the stainless steel
shaft. This could lead to breaks or
cracks in the rod lens system.
■Handle the telescope with care.
Hard knocks, particularly at the
distal end, may result in damage or
cracks in the telescope and allow
liquid, steam and other material to
penetrate. If so, the image will
appear foggy or have an unclear
visual area.
■To prevent damage when cleaning,
disinfecting and sterilizing the
telescope, it is recommended that
they be handled separately from
other instruments.
Cleaning
General Considerations – Adequate
reprocessing is contingent upon the
thoroughness of cleaning. Cleaning is
the initial step and sterilization occurs
later in reprocessing and is intended to
kill microorganisms to reduce the
likelihood of transmission and
possibilities of infection. To ensure
acceptable reprocessing, there should
be no delay between the steps in this
document.