Medtronic 8225401 Instructions for Use

Side By Side Bipolar Stimulating Probe

Sonde de stimulation bipolaire côte à côte /
Sonda di stimolazione bipolare affiancata /
Bipolare Side-by-Side-Stimulationssonde /
Sonda de estimulación bipolar lado a lado /
Bipolaire ‘Side By Side’ stimulatiesonde /
Side-by-side bipolær stimuleringssonde /
Rinnakkainen bipolaarinen
simulaatioanturi /
Side-by-Side bipolär stimuleringssond /
Sonda de estimulação bipolar lado-a-lado /
Διπολική μήλη διέγερσης με τους δύο
πόλους δίπλα-δίπλα /
Sonda stymulująca dwubiegunowa typu
side-by-side /
Bipolární stimulační sonda typu side-by­side /
Párhuzamos elrendezésű bipoláris
stimulálószonda /
Yan Yana Bipolar Stimülasyon Probu /
Side-ved-side bipolar stimuleringsprobe

Product Information and Instructions

Informations et instructions concernant
le produit / Informazioni sul prodotto ed
istruzioni per l’uso / Produktinformation
und Gebrauchsanweisung / Instrucciones e
información sobre el producto / Productinformatie
en instructies / Produktoplysninger og vejledning
/ tuotetta koskevat tiedot ja käyttöohjeet
/ Produktinformation och instruktioner
/ Informação do produto e instruções /
Πληροφορίε προϊόντο και οδηγίε /
Informacje o produkcie i instrukcje / Údaje
o výrobku a pokyny / Termék információ és
használati utasítás / Ürün Bilgileri ve Talimatlar /
Produktinformasjon og instruksjoner

Rx Only

Figure 1 / Figure 1 / Figura 1 / Abbildung 1 / Figura 1 / Aeelding 1 / Figur 1 /
Kuva 1 / Figur 1 / Figura 1 / Σχήμα 1 / Rysunek 1 / Obrázek 1 / 1. ábra / Şekil 1 /
Figur 1

A

B

C

ED

F

H

A Clear Insulation/Isolation transparente/Isolamento trasparente/Transparente

Isolierung/Aislamiento transparente/Heldere isolatie/Klar isolering/Kirkas
eriste/Klar isolering/Insulação clara/καθαρή Μόνωση/Przezroczysta warstwa
izolacyjna/Čirá izolace/Átlátszó szigetelés/eaf Yalıtım/Klar isolasjon

B Locator Guide/Guide de localisation/Guida localizzatore/Platzierungshilfe/Guía

localizadora/Opsporingsgids/Guide for positionsindikator/Paikannuslaitteen
ohjain/Lokaliseringsguide/Guia do localizador/Οδηγό Εντοπιστή/Element
służący do ustalania pozycji/Návod k lokátoru/Lokátor vezető/Yer Belirleyici
Kılavuz/Posisjonsindikator

C Small Pin/Petite broche/Pin piccolo/Kleiner Pin/Patilla pequeña/Kleine

pen/Lille stikben/Pieni liitin/Litet sti/Pino pequeno/Μικρή Καρφίδα/Mała
końcówka/Malý vývod/Kis tű/Küçük Pim/Liten pinne

D Black Insulation/Isolation noire/Isolamento nero/Schwarze Isolierung/

Aislamiento negro/Zwarte isolatie/Sort isolering/Musta eriste/Svart isolering/
Insulação escura/Μαύρη Μόνωση/Czarna warstwa izolacyjna/Černá izolace/
Fekete szigetelés/Siyah Yalıtım/Svart isolasjon

E Large Pin/Grande broche/Pin grande/Großer Pin/Patilla grande/Grote

pen/Stort stikben/Iso liitin/Stort sti/Pino grande/Μεγάλη Καρφίδα/Duża
końcówka/Velký vývod/Nagy tű/Büyük Pim/Stor pinne

F Small Diameter/Petit diamčtre/Diametro piccolo/Kleiner Durchmesser/

Diámetro pequeño/Kleine diameter/Lille diameter/Pieni halkaisija/Liten
diameter/Diâmetro pequeno/Μικρή ιάετρο/Mała średnica/Malý průměr/
Kis átmérő/Küçük Çap/Liten diameter

G Black Protected Pin/Broche protégée noire/Pin con protezione nera/Schwarzer

geschützter Pin/Patilla protegida negra/Zwarte beschermde pen/Sort beskyttet
stikben/Musta suojattu liitin/Svart skyddat sti/Pino preto protegido/Μαύρη
Προστατευένη Καρφίδα/Czarna chroniona końcówka/Černý chráněný vývod/
Fekete védett tű/Siyah Korumalı Pim/Svart beskyttet pinne

Large Diameter/Grand diamčtre/Diametro grande/Großer Durchmesser/

H

Diámetro grande/Grote diameter/Stor diameter/Suuri halkaisija/Stor diameter/
Diâmetro grande/Μεγάλη ιάετρο/Duża średnica/Velký průměr/Nagy
átmérő/Geni Çap/Stor diameter

Red Protected Pin/Broche protégée rouge/Pin con protezione rossa/Roter

I

geschützter Pin/Patilla protegida roja/Rode beschermde pen/Rødt beskyttet
stikben/Punainen suojattu liitin/Rött skyddat sti/Pino vermelho protegido/
Κόκκινη Προστατευένη Καρφίδα/Czarna chroniona końcówka/Červený
chráněný vývod/Piros védett tű/Kırmızı Korumalı Pim/Rød beskyttet pinne

G

I

2

Figure 2 / Figure 2 / Figura 2 / Abbildung 2 / Figura 2 / Aeelding 2 / Figur 2 /
Kuva 2 / Figur 2 / Figura 2 / Σχήμα 2 / Rysunek 2 / Obrázek 2 / 2. ábra / Şekil 2 /
Figur 2

Proximal

Cathode (-)

Distal

Correct

Proximal

Proximal

Cathode (-)

Cathode (-)

Distal

Incorrect

Proximal Proximal/Prossimale/Proximal/Proximal/Proximaal/Proksimal/

Cathode (-) Cathode/Catodo/Kathode/Cátodo/Kathode/Katode/Katodi/katod/

Distal Distal/Distale/Distal/Distal/Distaal/Distal/Distaalinen/Distal/Distal/

Correct Correcte/Corretto/Richtig/Correcto/Juist/Rigtigt/Oikein/Rätt/

Incorrect Incorrecte/Non corretto/Falsch/Incorrecto/Onjuist/Forkert/Väärin/

Proksimaalinen/Proximal/Proximal/Εγγύ Άκρο/Proksymalnie/
Proximální/Proximális/Proksimal/Proksimal

Catódo/Κάθοδο/Katoda/Katoda/Katód/Katot/Katode

Άπω Άκρο/Dystalnie/Distální/Disztális/Distal/Distal

Correcto/Σωστό/Prawidłowo/Správnì/Helyes/Doğru/Riktig

Fel/Incorrecto/Λανθασένο/Nieprawidłowo/Nesprávnì/Helytelen/
Yanlı/Feil

Distal

Incorrect

® is a registered mark of Medtronic Xomed, Inc. / ® est une marque déposée de Medtronic Xomed, Inc.
/ ® è un marchio registrato della Medtronic Xomed, Inc. / ® ist ein eingetragenes Warenzeichen von
Medtronic Xomed, Inc. / ® es una marca registrada de Medtronic Xomed, Inc. / ® is een geregistreerd
handelsmerk van Medtronic Xomed, Inc. / ® er et registreret mærke tilhørende Medtronic Xomed,
Inc. / ® on Medtronic Xomed, Inc.-yrityksen rekisteröity merkki. / ® är ett registrerat märke för
Medtronic Xomed, Inc. / ® é uma marca comercial da Medtronic Xomed, Inc. / ® είναι ένα
κατοχυρωένο σήα τη Medtronic Xomed, Inc. / ® jest zarejestrowanym znakiem towarowym
rmy Medtronic Xomed, Inc. / ® je registrovanou obchodní známkou společnosti Medtronic
Xomed, Inc. / ® bejegyzett védjegy, amely a Medtronic Xomed, Inc. tulajdonában van. / ®, Medtronic
Xomed, Inc.’in tescilli markalarıdır. / ® er registrerte varemerker for Medtronic Xomed, Inc.

3

English

DEVICE DE SCRIPTION

is device consists of a stimulator probe that is insulated with uoroplastic up to
the active tip, and has a bipolar cable ending in connectors.

INTE NDED USE

is device is intended for use as an intraoperative motor nerve stimulator with the
Nerve Integrity Monitor or other EMG monitors.

INDICATION S

is device is indicated for use for intraoperative motor nerve location.

CONTR AINDICATIONS

e use of paralyzing anesthetic agents will signicantly reduce, if not completely
eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve
paralysis is suspected, consult anesthesiologist.

WARNING S

Read and understand the Warnings and Precautions, associated with the use of Side
By Side Bipolar Stimulator Probe, contained within the Instructions For Use for the
specic Monitoring equipment you are using.

CAUTION

• e stimulator plugs into the cable only one way. Any attempt to forcibly reverse
this connection will result in damage to the connections, rendering the delivery
of stimulating current ineective.

• To ensure delivery of current to intended tissues, use only with EMG monitor(s)
equipped with active audio and/or visual current delivered feedback systems.

DIREC TIONS FOR USE

When the stimulator and cable are properly assembled and the pin connectors are
plugged into the corresponding red (+) and black (-) Stimulator Output jacks in
the Patient Interface of the NIM®, the le stimulating tip of the probe is the cathode
(negative).

CABLE C ONNECTIONS

See gure 1

STIMULATION

• Verify prior to surgical use that the probe delivers current at the intended
setting as evidenced by the EMG monitor’s audio and/or visual current delivered
feedback system.

• Electrical stimulation is most eective when the stimulating current ow is
from proximal-to-distal on neural tissue. e NIM® stimulating current ow is
from negative (-) to positive (+) (cathode to anode). Both electrodes should be
in complete contact with neural tissue. It is important to position the bipolar
stimulator with the cathode (-) electrode in the most proximal position on
neural tissue.

CORR ECT USE (See gure 2)

1. Tips must be parallel to nerve.

2. Cathode (negative) must be proximal.

STER ILITY

THIS DEVICE IS PROVIDED STERILE AND IS INTENDED FOR SINGLE
PATIENT USE ONLY. DO NOT RESTERILIZE THIS DEVICE. MEDTRONIC
XOMED ASSUMES NO LIABILITY FOR DEVICES THAT HAVE BEEN
RESTERILZED BY HEALTH CARE FACILITIES.

LIMI TED WARR ANTY

A. is LIMITED WARRANTY provides assurance for the customer who

purchases a Medtronic Xomed Product (hereinaer the “Product”) that should
the Product fail to function to Medtronic Xomed’s published specications
during the term of this LIMITED WARRANTY (one year from the date of
shipment for new Product, 90 days from date of shipment for refurbished or
used Product), Medtronic Xomed will either replace, repair, or issue a credit
(adjusted to reect the age of the Product) for the Product or any portion
thereof. is LIMITED WARRANTY is extended only to the buyer purchasing
the Product directly from Medtronic Xomed or from its aliate or its
authorized distributor or representative.

B. To qualify for this LIMITED WARRANTY, the following conditions must be

met:

(1) e Product must be used on or before its “Use By” or “Use Before” date,

if applicable.

(2) e Product must be used in accordance with its labeling and may not be

altered or subjected to misuse, abuse, accident or improper handling.

4

Français

(3) Medtronic Xomed must be notied in writing within thirty (30) days

following discovery of a defect.

(4) e Product must be returned to Medtronic Xomed within thirty (30)

days of Medtronic Xomed receiving notice as provided for in (3) above.

(5) Upon examination of the Product by Medtronic Xomed, Medtronic

Xomed shall have determined that: (i) the Product was not repaired
or altered by anyone other than Medtronic Xomed or its authorized
representative, (ii) the Product was not operated under conditions other
than normal use, and (iii) the prescribed periodic maintenance and
services have been performed on the Product.

C. is LIMITED WARRANTY is limited to its express terms. THIS LIMITED

WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE. In no event shall Medtronic Xomed be liable for
any consequential, incidental, prospective or other similar damage resulting
from a defect, failure, or malfunction of the Product, whether a claim for such
damage is based upon the warranty, contract, negligence or otherwise.

D. e exclusions and limitations set out above are not intended to, and should

not be construed so as to, contravene mandatory provisions of applicable law.
Users may benet from statutory warranty rights under legislation governing
the sale of consumer goods. If any part or term of this LIMITED WARRANTY
is held by any court of competent jurisdiction to be illegal, unenforceable, or
in conict with applicable law, the validity of the remaining portion of the
LIMITED WARRANTY shall not be aected, and all rights and obligations
shall be construed and enforced as if this LIMITED WARRANTY did not
contain the particular part or term held to be invalid.

CUSTOMER SERVICE INFOR MATION

For further information regarding the use of this product or to report any
problems, please contact Medtronic using the appropriate information provided on
the blue and white contact information card packaged with each device; or contact
your local distributor.

DESCR IPTION DU DISPOSIT IF

Ce dispositif est constitué d’une sonde de stimulation isolée par du plastique uoré
jusqu’à l’extrémité active et posčde un câble bipolaire terminé par des connecteurs.

USAGE PRÉV U

Ce dispositif est destiné à servir de stimulateur peropératoire des nerfs moteurs
avec le moniteur d’intégrité des nerfs ou avec d’autres moniteurs pour EMG.

INDICATION S

Ce dispositif est destiné à la localisation peropératoire des nerfs moteurs.

CONTR E-INDICATION

Les anesthésiques paralysants réduiront notablement, voire même élimineront
complčtement les réponses électromyographiques (EMG) à la stimulation nerveuse
directe ou passive. En cas de suspicion de paralysie nerveuse, toujours demander
l’avis d’un anesthésiste.

AVERTISSE MENTS

Il est important de lire et comprendre les avertissements et les précautions
concernant l’utilisation d’un Sonde de stimulation bipolaire côte à côte dans le
mode d’emploi de l’appareil de monitorage utilisé.

MISE EN GARDE

• Le stimulateur ne se raccorde au câble que dans un sens. Toute tentative visant à
forcer l’inversion de cette connexion endommagera les connexions, ce qui rendra
la délivrance du courant de stimulation inecace.

• Pour garantir la délivrance de courant aux tissus visés, utiliser ce dispositif
uniquement avec un ou des moniteurs EMG équipés de systčmes actifs de
rétrocontrôle sonore et/ou visuel du courant délivré.

MODE D’EM PLOI

Lorsque le stimulateur et le câble sont correctement assemblés et que les
connecteurs à broches sont raccordés aux ches de sortie stimulateur rouge (+) et
noire (-) correspondantes au niveau de l’interface patient du NIM®, l’extrémité de
stimulation gauche de la sonde est la cathode (électrode négative).

CONNETEUR S DU CÂBLE

Voir gure 1

5

Italiano

STIMULATION

• Avant toute utilisation chirurgicale, vérier à l’aide du systčme de rétrocontrôle
sonore et/ou visuel du courant fourni par le moniteur de l’EMG si le courant
délivré par la sonde correspond au réglage prévu.

• La stimulation électrique est la plus ecace lorsque le courant de stimulation
circule le long du tissu neural dans le sens proximal vers distal. Le sens de
circulation du courant de stimulation des dispositifs NIM® est de l’électrode
négative (-) vers l’électrode positive (+) (de la cathode vers l’anode). Les deux
électrodes doivent être totalement en contact avec le tissu neural. Il est important
de positionner le stimulateur bipolaire avec la cathode (-) en position proximale
sur le tissu neural.

UTIL ISATION CORREC TE (Voir gure 2)

1. Les extrémités doivent être parallčles aux nerfs.

2. La cathode (électrode négative) doit se trouver en position proximale.

STER ILITE

CET ACCESSOIRE EST LIVRÉ STÉRILE ET EST STRICTEMENT À USAGE
UNIQUE. NE PAS LE RESTÉRILISER. MEDTRONIC XOMED DÉCLINE
TOUTE RESPONSABILITÉ POUR LES ACCESSOIRES QUI AURAIENT ÉTÉ
RESTÉRILISÉS PAR L’ÉTABLISSEMENT HOSPITALIER.

GARANTI E LIMITÉE

www.medtronicENT-TechComms.com

SERVICE CLIEN TELE

Pour plus d’informations concernant l’utilisation de ce produit ou pour signaler
un problème quelconque, contacter Medtronic, en mentionnant les informations
appropriées indiquées sur la che de renseignements bleue et blanche fournie avec
chaque dispositif ; ou contacter votre distributeur local.

DESCR IZIONE DEL DISPOSITIVO

Questo dispositivo consiste in una sonda di stimolazione isolata con uoroplastico
no alla punta attiva e dotata di un cavo bipolare terminante in connettori.

USO PREV ISTO

Questo dispositivo deve essere utilizzato come uno stimolatore intraoperatorio del
nervo motore con il monitor Ner ve Integrity o con altri monitor EMG.

INDICAZIONI

Questo dispositivo č indicato per la localizzazione intraoperatoria del nervo
motore.

CONTROINDICAZIONI

L’uso di agenti anestetici paralizzanti consente di ridurre in maniera
signicativa, se non eliminare completamente, le risposte EMG alla
stimolazione neurale diretta o passiva. Ove si sospetti una paralisi nervosa,
consultare un anestesista.

AVVERTENZE

Leggere attentamente le avvertenze e le precauzioni associate all’utilizzo dello
Sonda di stimolazione bipolare aancata, contenute nelle istruzioni per l’uso
dell’apparecchiatura di monitoraggio utilizzata.

ATTENZIONE

• Lo stimolatore si inserisce nel cavo solo in un senso. Qualsiasi tentativo di
forzare la connessione in senso contrario provocherà danni alle connessioni,
rendendo inecace la somministrazione della corrente di stimolazione.

• Per garantire la somministrazione della corrente ai tessuti prescelti, utilizzarlo
esclusivamente con monitor EMG dotati di sistemi attivi audio e/o video di
rialimentazione (feedback) della corrente erogata.

ISTRUZIONI PER L’USO

Una volta installati correttamente lo stimolatore e il cavo, e dopo aver inserito i
connettori a pin nelle corrispondenti prese jack rossa (+) e nera (-) dell’output dello
stimolatore nell’interfaccia paziente del NIM®, la punta di stimolazione sinistra
della sonda č il catodo (negativo).

CONNESSIONI A CAVO

Vedere la gura 1

STIMOLAZIONE

• Prima dell’utilizzo chirurgico, vericare che la sonda eroghi corrente nella
collocazione prescelta, come evidenziato dal sistema attivo audio e/o video di
rialimentazione (feedback) della corrente erogata del monitor EMG.

6