Care Fusion Snowden-Pencer User manual

Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
LC 04/15/13
LC 04/18/13
LC 05/07/13
Laparoscopic Ergonomic Reposable
Scissors
Ciseaux ergonomiques et laparascopiques
semi-réutilisables
Ergonomische, teilweise wiederverwendbare
(reposable) Laparoskopieschere
Forbici laparoscopiche ergonomiche
limitatamente riutilizzabili
Tijera laparoscópica ergonómica de apoyo
Tesoura laparoscópica descartável e
ergonómica
Laparoscopische ergonomische schaar voor
beperkt meermalig gebruik
Laparoskopisk ergonomisk reponerbar sax
Laparoskopisk, ergonomisk saks til
begrænset brug
Laparoskooppiset, ergonomiset, osittain
uudelleenkäytettävät sakset
Delvis gjenbrukbar laparoskopisk
ergonomisk saks
Λαπαροσκοσπικά, Εργονομικά, Μη
Επαναχρησιμοποιούμενα Ψαλίδια
腹腔鏡用人間工学的リポーザブル剪刀Laparoskopické ergonomické nůžky s
vyměnitelnými špičkami
Ergonomiczne laparoskopowe nożyce
zuchwytem wielorazowego użytku
Karın İçbakı Elverişli Yatırılabilir Makas
Foarfece laparoscopic ergonomic cu număr
limitat de utilizări
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Snowden-Pencer ™
U A
CareFusion
1500 Waukegan Road
McGaw Park, IL 60085 U.S.A.
CareFusion France 309 .A. .
8 bis rue de la Renaissance
44110 Châteaubriant - France
CF36-1833B / 26-2920-C • 2013-05
0123
Manufactured for
Snowden-Pencer, CareFusion, and the CareFusion logo are
trademarks or registered trademarks of CareFusion
Corporation, or one of its subsidiaries.
ValleyLab and Force are trademarks of Covidien AG.
ConMed is a registered trademark of ConMed Corporation.
System 5000 is a trademark of ConMed Corporation.
Ellman and Surgitron are registered trademarks of Ellman
International, Inc.
© 2013, CareFusion Corporation or one of its subsidiaries.
All rights reserved.
Caution: Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician or licensed
practitioner.
For Single Use Only

Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
LC 04/15/13
LC 04/18/13
LC 05/07/13
ymbol, ymboles, ymbole,
imboli, ímbolos, ymbolen,
ymboler, ymbolit, Σύμβολα,
記号, ymboly, imgeler,
imboluri
Consult instructions for use.
Consulter les instructions d'utilisation.
Bedienungsanleitung einsehen.
Consultare le istruzioni per l’uso.
Consultar las instrucciones de uso.
Consulte as instruções de utilização.
Raadpleeg de gebruiksaanwijzing.
Se till att studera bruksanvisningen för råd.
Se brugsanvisningen.
Katso käyttöohje.
Se bruksanvisningen.
Συμβουλευτείτε τις οδηγίες χρήσης.
使用説明書を参照してください。
Přečtěte si návod na použití.
Zapoznać się z instrukcją obsługi.
Kullanım yönergelerine bakınız.
Consultaţi instrucţiunile de utilizare.
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Do not use if package is opened or damaged.
Ne pas utiliser si l'emballage est ouvert ou
endommagé.
Nicht verwenden, wenn die Verpackung
geöffnet wurde oder beschädigt ist.
Non usare se la confezione è aperta o
danneggiata.
No utilizar si el empaque está abierto o
dañado.
Não utilize se a embalagem estiver aberta ou
danificada.
Niet gebruiken als de verpakking geopend of
beschadigd is.
Får ej användas om förpackningen har öppnats
tidigare eller är skadad.
Må ikke anvendes, hvis emballagen er åbnet
eller beskadiget.
Älä käytä, jos pakkaus on auki tai
vahingoittunut.
Skal ikke brukes hvis pakken er åpnet eller
skadet.
Να μην χρησιμοποιείται εάν η συσκευασία
έχει ανοιχθεί ήυποστεί φθορά.
パッケージが開封されていたり、損傷がある場合は使用しないでください。
Nepoužívejte, pokud je balení otevřeno nebo
poškozeno.
Nie wolno stosować w przypadku otwartego
lub uszkodzonego opakowania.
Paket açılmış ya da hasarlı ise kullanmayınız.
A nu se utiliza dacă ambalajul este deschis sau
deteriorat.
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Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
(1)
(b)
(2)
(4)
(a)
(c)
(d)
(e)
Figure, chéma, Figura, Abb,
Afbeelding, Figur, Kuva, Εικόνα,
図, Obrázek, Şekil,Rysunek,
(3)
LC 04/15/13
LC 04/18/13
LC 05/07/13

STERILE
EO
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
LC 04/15/13
LC 04/18/13
LC 05/07/13
ymbol, ymboles, ymbole, imboli,
ímbolos, ymbolen, ymboler,
ymbolit, Σύμβολα, 記号, ymboly,
imgeler, imboluri
For single use only.
Pour usage unique.
Nur zum Einmalgebrauch.
Esclusivamente monouso.
Sólo para un uso.
Para uma única utilização.
Uitsluitend voor eenmalig gebruik.
Endast för engångsbruk.
Udelukkende til engangsbrug.
Ainoastaan kertakäyttöön.
Bare til engangsbruk.
Μόνο για μια χρήση.
本品は一回のみ使用できます。
Pouze pro jednorázové použití.
Tylko do jednorazowego użytku.
Yalnız tek kullanımlıktır.
Exclusiv de unică folosin.ă
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Sterilized using Ethylene Oxide.
Stérilisé à l'oxyde d'éthylène.
Mit Ethylenoxid sterilisiert.
Sterilizzare con ossido di etilene.
Esterilizado utilizando óxido de etileno.
Esterilizada utilizando óxido de etileno.
Gesteriliseerd met ethyleenoxide.
Steriliserad med etylenoxid.
Steriliseret med ethylenoxid.
Steriloitu käyttäen eteenioksidia.
Sterilisert med etylenoksid.
Έχει αποστειρωθεί με οξείδιο του αιθυλενίου.
酸化エチレンで滅菌されています。
terilizováno s použitím etylénoxidu.
Produkt wyjałowiony tlenkiem etylenu.
Etilen oksitle arındırılmıştır.
terilizat folosind oxid de etilenă.
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Catalog Numbers
SP8301, SP8302, SP8303, SP8401, SP8402, SP8403
Device Features
a. Insert
b. Handle
c. Rotation Knob
d. Nose Key
e. Assembly/Release Buttons
Indications For Use
The Snowden-Pencer™ Laparoscopic Ergonomic Reposable
Scissors is a monopolar electrosurgical instrument indicated to
be used in general laparoscopic and gynecologic procedures to
allow high frequency monopolar cutting and coagulation. The
reposable scissors are indicated to mechanically cut tissue and
suture.
Contraindications
The Snowden-Pencer Laparoscopic Ergonomic Reposable
Scissors have not been shown to be effective for tubal
sterilization or tubal coagulation for sterilization procedures. Do
not use the Reposable Scissors for these procedures.
Handle Compatibility
The Snowden-Pencer Laparoscopic Ergonomic Reposable
Scissors are intended to be used with Snowden-Pencer
Ergonomic Take-Apart Reusable Handles SP94 and SP95.
Electrode Cable Compatibility
Snowden-Pencer monopolar electrosurgical devices are
compatible with the Unipolar Bovie Cord with universal plug
(88-9199) or equivalent.
Generator Compatibility
The Snowden-Pencer Laparoscopic Ergonomic Reposable
Scissors are only compatible with FDA-cleared high frequency
monopolar electrosurgical generators such as the ValleyLab™
Force™ 2 PC, Conmed®, System 5000™, Ellman®, Surgitron®
4.0 Dual RF. Refer to the generator manual for more detailed
information on using this device under various modes of
operation.
How upplied
Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors
are packaged sterile. Do not use if single use sterile package is
opened, damaged, or expired.
Reference product Instructions for Use (IFU# CF36-1750/26-
0792) for complete cleaning and sterilization instructions for
the Snowden-Pencer Ergonomic Reusable Handle.
Limitations on Reprocessing
Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors
are single use only devices. Do not reuse. Reuse may result in a
non-functional product or contribute to cross-contamination.
Warnings
• Snowden-Pencer devices shall be used in accordance with
these instructions for use. Read all sections of this insert
prior to use. Improper use of these devices may cause
serious injury.
• When not in use, store in a location that is isolated from the
patient.
• Prior to use of the device in patients who have cardiac
pacemakers or other active implants, a possible hazard
exists because interference with the action of the device may
occur or damage to the device may occur. Consult device
manufacturer’s instructions for use. In case of doubt,
qualified advice should be obtained.
•To prevent the possibility of electrical shocks or burns, do
not use devices with breaks in the insulation.
• Gas embolism may result from over-insufflation of air, inert
gas prior to HF surgery or laser assist gas.
• The Snowden-Pencer Laparoscopic Ergonomic Reposable
Scissors is a monopolar device and should only be
connected to an electrosurgical generator that is compatible
with monopolar devices.
•Do not exceed the 1 kVp maximum rating specified for this
device. Adjust the electrosurgical generator to a setting
appropriate for the maximum peak output voltage.
• A dispersive electrode, such as a grounding pad, should be
used with the device and electrosurgical generator to
prevent burns/injury to the patient when using the
monopolar device. Ensure the pad is properly sized and
properly placed and always recheck the pad when patient is
moved. It is recommended that the device is used with an
electrosurgical generator that contains contact quality
monitoring (return electrode monitoring) with a signal to
indicate there is contact to the patient.
1
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
LC 04/15/13
LC 04/18/13
LC 05/07/13
en
For Outside United States Market.The Snowden-Pencer
Laparoscopic Ergonomic Reposable Scissors are compatible
with IEC compliant high frequency monopolar electrosurgical
generators. Refer to the generator manual for more detailed
information on using this device under various modes of
operation.