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Instructions for Use
RFP-100A Footswitch
ENGLISH ................................................................................................................................... 1
FRANÇAIS ................................................................................................................................. 2
ESPAÑOL .................................................................................................................................. 3
PORTUGUÊS ............................................................................................................................ 4
ITALIANO .................................................................................................................................. 5
DUTCH ....................................................................................................................................... 6
DEUTSCH .................................................................................................................................. 7
ČEŠTINA ................................................................................................................................... 8
DANSK ...................................................................................................................................... 9
SUOMI ..................................................................................................................................... 10
NORSK .................................................................................................................................... 11
SVENSKA ................................................................................................................................ 12
SLOVENSKY ........................................................................................................................... 13
ROMÂNĂ ................................................................................................................................. 14
HRVATSKI ............................................................................................................................... 15
MAGYAR ................................................................................................................................ 16
TÜRKÇE ................................................................................................................................. 17
ΕΛΛΗΝΙΚΆ ............................................................................................................................... 18
РУССКИЙ ............................................................................................................................... 19
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801 Fax: (514)
488-7209
www.baylismedical.com
EU Authorized Representative:
Quality First International OÜ
Laki 30, 12915 Tallinn
Estonia
Telephone: +372 610 41 96
Email: enquiries@qualityfirstint.ee
© Copyright Baylis Medical Company Inc., 2011-2023
Baylis Medical and the Baylis Medical logo are trademarks of Baylis Medical
Technologies Inc.
Page 1 of 20
English
Carefully read all instructions prior to use. Observe all contraindications, warnings and
precautions noted in these instructions. Failure to do so may result in patient complications.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Notice (EU): Any serious incident as defined in the EU Medical Device Regulation (2017/745)
that has occurred in relation to the RFP-100A Footswitch should be reported to Baylis Medical
Company Inc. and the competent authority of the EU Member State in which the physician and/or
patient is established.
I.
DEVICE DESCRIPTION
The RFP-100A Footswitch (Footswitch) is used with the RFP-100A Baylis Medical Company
Radiofrequency Puncture Generator (RFP-100A Generator) for RF energy delivery. The
Footswitch is provided with redundant micro switches and is used as an alternative to the RF
On/Off button on the RFP-100A Generator for RF energy delivery.
II.
INDICATIONS FOR USE
The Footswitch is to be used with the RFP-100A Generator.
III.
CONTRAINDICATIONS
The Footswitch is not recommended for uses other than the indicated use. The RFP-100A
Generator Instructions for Use should be consulted for any other contraindications that may be
associated with use of the RFP-100A Generator.
IV.
WARNINGS
Only physicians with a thorough understanding of radiofrequency powered puncture
procedures should use this device.
Do not alter this device in any way.
The Footswitch must be used with the RFP-100A Generator only. Attempts to use it with
other radiofrequency puncture generators can result in serious electrical injury of the
patient and/or operator.
V.
PRECAUTIONS
Do not attempt to use the Footswitch before thoroughly reading the accompanying
Instructions for Use and RFP-100A Generator Instructions for Use manual.
Visually inspect the Footswitch prior to use. Do not use the Footswitch if there is any
damage.
Regularly inspect and maintain the Footswitch according to section VII. and X.
VI.
ADVERSE EVENTS
The RFP-100A Generator Instructions for Use should be consulted for any adverse events.
VII.
INSPECTION PRIOR TO USE
Prior to use all the individual components including the RFP-100A Generator and the Footswitch
should be carefully examined for damage or defects, as should all equipment used in the
procedure. Do not use defective equipment.
VIII.
DIRECTIONS FOR USE
The Footswitch serves as an actuator for the connected device. When connected to the RFP-
100A Generator, the Footswitch can be used as an alternative to the RF ON/OFF button on the
RFP-100A Generator to activate or terminate RF energy delivery.
For Footswitch procedure and connections to the RFP-100A Generator please refer to the RFP-
100A Generator Instructions for Use manual.
IX.
CLEANING INSTRUCTIONS
The outer surface of the Footswitch may be cleaned with a mild soapy solution. DO NOT
immerse the Footswitch in any liquid. Avoid caustic or abrasive cleaners. If disinfecting is
required, 70% isopropyl alcohol or 5% solution of household bleach may be used to clean the
outer surfaces. The Footswitch cannot be sterilized.
X.
MAINTENANCE
Regular checks or maintenance is recommended according to ambient conditions and
application frequency:
Check actuating elements for mechanical function. To perform this test, disconnect the
footswitch from RFP-100A Generator. Press on the footswitch and release force. Confirm that
the footswitch returns to its rest position (released state).
Check housing and connecting cable for damage and harmful dirt.
XI.
DISPOSAL OF WASTE
The Footswitch is reusable. However, when the Footswitch is determined to be unusable,
dispose of the Footswitch in compliance with standard hospital procedures.
XII.
CUSTOMER SERVICE AND PRODUCT RETURN INFORMATION
If you have any problems with or questions about Baylis Medical Equipment contact our
technical support personnel.
NOTES:
1.
In order to return products you must have a return authorization number before shipping
the products back to Baylis Medical Company.
2.
Baylis Medical will not accept any piece of used equipment without a sterilization
certificate. .
XIII.
LABELING AND SYMBOLS
Manufacturer
Medical Device
Caution
Only for EU member states:
Use of this symbol indicates that the product must be
disposed of in a way that complies with local and national
regulations. For questions regarding recycling of this
device please contact your distributor
Federal (U.S.A.) law restricts this device to sale by or on
the order of a physician.
Date of
Manufacture
EU Authorized Representative
Consult
Instructions
for Use
Model
number
Serial
Number
Footswitch
Use with: BMC RFP-100A generators
only
DMR RFA-FS 3.3 V-12
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Inhoudsopgave
Gerelateerde Handleidingen voor Baylis Medical RFP-100A Footswitch
Samenvatting van Inhoud voor Baylis Medical RFP-100A Footswitch
-
Pagina 1: Inhoudsopgave
Notice (EU): Any serious incident as defined in the EU Medical Device Regulation (2017/745) that has occurred in relation to the RFP-100A Footswitch should be reported to Baylis Medical Company Inc. and the competent authority of the EU Member State in which the physician and/or patient is established. -
Pagina 2: Français
Date de L’interrupteur This warranty is valid only to the original purchaser of Baylis Medical products directly from a fabrication au pied Baylis Medical authorized agent. The original purchaser cannot transfer the warranty. Use of any BMC product shall be deemed acceptance of the terms and conditions herein. -
Pagina 3: Español
L’ACHETEUR DES BIENS PRÉCISÉS VENDUS PAR BMC À L’ACHETEUR, QUI ENTRAÎNE LA RÉCLAMATION DE RESPONSABILITÉ. Aucun agent, employé ni représentant de Baylis Medical n’a l’autorité de lier la société à toute autre garantie, affirmation ou représentation concernant le produit. Precaución Número de serie... -
Pagina 4: Português
DESCRIÇÃO DO DISPOSITIVO Material de Contacto Ródio O RFP-100A Footswitch (Pedal) é usado com o Gerador de Punção por Radiofrequência RFP- Classe de Proteção IP X8 conforme IEC 60529 100A da Baylis Medical Company (Gerador RFP-100A) para fornecimento de energia de RF. -
Pagina 5: Italiano
(2017/745) che si è verificato in relazione al il Pedale di controllo deve essere segnalato Materiale di contatto Rodio a Baylis Medical Company Inc. e all'autorità competente dello Stato membro dell'UE in cui è Classe di protezione IP X8 per IEC 60529 domiciliato il medico e/o il paziente. -
Pagina 6: Dutch
IEC 60601-1-2 (2017/745) dat zich heeft voorgedaan met betrekking tot de voetschakelaar moet worden gemeld IEC 60601-2-2 aan de Baylis Medical Company Inc. en de bevoegde autoriteit van de EU-lidstaat waar de arts IEC 60601-2-22 en/of patiënt is gevestigd. IEC 60529... -
Pagina 7: Deutsch
Niet-pyrogeen Medizinprodukteverordnung (2017/745), der im Zusammenhang mit dem Fußschalter aufgetreten ist, sollte der Baylis Medical Company Inc. und der zuständigen Behörde des EU- Mitgliedstaates, in dem der Arzt und/oder der Patient niedergelassen ist, gemeldet werden. BEPERKTE GARANTIE – Artikelen voor eenmalig gebruik en accessoires... -
Pagina 8: Čeština
(2017/745), ke které došlo v souvislosti s nožním spínačem, by wurden, und sie gilt nicht für Produkte von BMC, die unsachgemäß gelagert oder měla být informována společnost Baylis Medical Company Inc. a příslušný úřad členského státu unsachgemäß gereinigt, installiert, betrieben oder entgegen den Anweisungen von EU, ve kterém má... -
Pagina 9: Dansk
INFORMACE O SLUŽBÁCH ZÁKAZNÍKŮM A VRÁCENÍ PRODUKTU ODPOVĚDNOSTI VŮČI PRODUKTU NEBO JINÉ PRÁVNÍ NEBO EKVITNÍ Pokud máte nějaké problémy se zařízením Baylis Medical nebo otázky k němu, kontaktujte TEORIE KUPUJÍCÍ VÝSLOVNĚ SOUHLASÍ, ŽE SPOLEČNOST BMC NEBUDE personál naší technické podpory. -
Pagina 10: Suomi
Vigtigt Serienummer påstand vedrørende produktet. Denne garanti gælder kun for den oprindelige køber af produkter fra Baylis Medical, som er købt Kun til EU-medlemslande: direkte fra en autoriseret Baylis Medical-agent. Den oprindelige køber kan ikke overføre Brug af dette symbol angiver, at produktet skal bortskaffes på... -
Pagina 11: Norsk
XII. KUNDESERVICE- OG PRODUKTRETURINFORMASJON KAIKKIIN MUIHIN VAATIMUKSIIN JA VASTUIHIN, MUKAAN LUKIEN MIHIN TAHANSA Hvis du har problemer med eller spørsmål om utstyr fra Baylis Medical, kan du kontakte vårt KORVAUSVASTUISIIN LIITTYVÄT VELVOITTEET, OLIPA VAKUUTUSTA TAI EI, EI YLITÄ tekniske støttepersonell. -
Pagina 12: Svenska
Pedalen Meddelande (EU): Alla allvarliga tillbud, enligt definitionen i EU:s förordning om medicintekniska produkter (2017/745), som inträffar i samband med fotpedalen ska rapporteras till Baylis Medical Company Inc. och den behöriga myndigheten i den EU-medlemsstat där läkaren och/eller Autorisert representant i EU patienten är bosatt. -
Pagina 13: Slovensky
Nožný Denna garanti gäller endast för den ursprungliga köparen av Baylis Medical-produkter som köps Dátum výroby spínač direkt från ett auktoriserat Baylis Medical-ombud. Den ursprungliga köparen kan inte överlåta garantin. -
Pagina 14: Română
înainte de a expedia produsele înapoi la Baylis Medical Company. UVÁDZA OBMEDZENIE ZODPOVEDNOSTI, ODMIETNUTIE ZÁRUKY ALEBO PODMIENKU Baylis Medical nu va accepta niciun echipament folosit care nu include un certificat de ALEBO VYLÚČENIE ŠKÔD, JE ODDELITEĽNÉ A NEZÁVISLÉ OD AKÉHOKOĽVEK INÉHO sterilizare. -
Pagina 15: Hrvatski
INFORMACIJE O KORISNIČKOM SERVISU I POVRATU PROIZVODA OBLIGATORII ÎN BAZA PREZENTULUI DOCUMENT. ORICE ACȚIUNE ÎMPOTRIVA Ako imate bilo kakvih problema ili pitanja u vezi s opremom društva Baylis Medical, obratite se VÂNZĂTORULUI TREBUIE INIȚIATĂ ÎN TERMEN DE OPTSPREZECE (18) LUNI DUPĂ... -
Pagina 16: Magyar
Rendszeresen ellenőrizze és tartsa karban a lábkapcsolót a VII. és a X. szakaszban Društvo Baylis Medical Company Inc. (BMC) jamči da njegovi proizvodi za jednokratnu upotrebu foglaltak szerint. i pribor nemaju nedostataka u materijalu i izradi. BMC jamči da će sterilni proizvodi ostati sterilni NEMKÍVÁNATOS ESEMÉNYEK... -
Pagina 17: Türkçe
Uyarı (AB): RFP-100A Ayak Pedalı ile ilgili olarak ve AB Tıbbi Cihaz Yönetmeliğinde (2017/745) Koruma Sınıfı IEC 60529 uyarınca IP X8 tanımlandığı şekilde meydana gelen her türlü ciddi olumsuz olay Baylis Medical Company Inc.'e Elektrik Bağlantısı 4 kutuplu LEMO Konektörü olan 3 m blendajlı kablo ve hekim ve/veya hastanın bulunduğu AB Üye Ülkesinin yetkili makamına bildirilmelidir. -
Pagina 18: Ελληνικά
χειριστή λόγω ηλεκτρισμού. ΠΕΡΙΟΡΙΣΜΕΝΗ ΕΓΓΥΗΣΗ – Αναλώσιμα και παρελκόμενα ΠΡΟΦΥΛΑΞΕΙΣ Η Baylis Medical Company Inc. (BMC) παρέχει εγγύηση για τα προϊόντα μίας χρήσης και τα Μην επιχειρήσετε να χρησιμοποιήσετε τον ποδοδιακόπτη πριν διαβάσετε προσεκτικά τις παρελκόμενα έναντι ελαττωμάτων στα υλικά και την κατασκευή. -
Pagina 19: Русский
Медицинское Номер επιβεβαίωση ή εκπροσώπηση που αφορά το προϊόν. изделие модели Η παρούσα εγγύηση ισχύει μόνο για τον αρχικό αγοραστή των προϊόντων της Baylis Medical Серийный απευθείας από εξουσιοδοτημένο αντιπρόσωπο της Baylis Medical. Ο αρχικός αγοραστής δεν Внимание номер μπορεί να μεταβιβάσει την εγγύηση. - Pagina 20 ВОЗНИКАЕТ ТРЕБОВАНИЕ ОБ ОТВЕТСТВЕННОСТИ. Никакие агенты, сотрудники или представители компании Baylis Medical не имеют полномочий связывать Компанию какой-либо другой гарантией, подтверждением или представлением в отношении изделия. Настоящая гарантия распространяется только на первоначального покупателя продукции компании Baylis Medical непосредственно у уполномоченного представителя компании...