Instructions for Use
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DYONICS™ POWER II Footswitch Device Description The Smith & Nephew DYONICS POWER II Footswitch (REF 72201092) is a wired footswitch designed for use with the DYONICS POWER II Control Unit (REF 72200873) to control blade action. The footswitch communicates switch and pedal action to the control unit. The footswitch has three control pedals and two switches. The pedals control the forward, reverse, and oscillate modes. The buttons control the Lavage mode and Blade Window Lock functions. The footswitch can be operated in one of two modes: On/Off or Variable. On/Off will set the footswitch pedals to switch operation. Variable will set the footswitch pedals to adjust the handpiece speed based on pedal pressure.
Indications for Use
Contraindications None known.
Warnings
DYONICS™ POWER II Footswitch
• It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.
Figure 1: The DYONICS POWER II Footswitch
Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • In all cases, the judgment of the physician (in the best interest of the patient) may take precedence over the procedures described in this Instructions for Use.
The footswitch is required when using the following handpieces:
Instructions for Use
• POWERMAX™ Handpiece (REF 7210586) • POWERMAX ELITE™ Handpiece (REF 72200617) • Mini Shaver Handpiece (REF 7205357) The footswitch also may be used with hand control shaver handpieces.
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• Read the Smith & Nephew DYONICS POWER II Control System Operations/Service Manual (REF 10600181) completely prior to use.
• Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device.
• UltraLight Shaver Handpiece (REF 7205971)
Blade Window Lock
<> L
• Read these instructions completely prior to use.
The DYONICS POWER II Footswitch is intended as an accessory to the Smith & Nephew DYONICS POWER II Control System. The DYONICS POWER II Control System is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure. • Standard Shaver Handpiece (REF 7205355)
Note: The footswitch does not control the Forward or Reverse Speed Shift settings. The <> (oscillate) pedal causes the control unit to send alternate forward and reverse commands to the handpiece. The control unit continues the alternating signals until the foot is removed from the <> pedal.
• Inspect all components regularly for wear. • To prevent damage to the control unit connector parts, do not plug in wet. Ensure that cleaned footswitch cable connectors are completely dry prior to connecting to the control unit.
Connect the DYONICS POWER II Footswitch to the footswitch connector port located on the front panel of the DYONICS POWER II Control Unit. CAUTION: To prevent damage to the control unit connector parts, do not plug in wet. Ensure that cleaned footswitch cable connectors are completely dry prior to connecting to the control unit.
DYONICS™ POWER II Footswitch
Instructions for Use
The DYONICS™ POWER II Footswitch has three control pedals and two switches. The pedals are labeled L, R, and <>. The L and R pedals default to reverse and forward, respectively. Depressing the left or right pedal causes the control unit to supply power to the handpiece to drive the blade in the direction indicated. The left and right pedals can be configured to run either forward or reverse. The center (<>) pedal is always oscillate. The two switches provide control for the Blade Window Lock function and the DYONICS 25 Fluid Management System’s Lavage function. The footswitch can be assigned to either Port A or Port B on the DYONICS Power II Control Unit. For more information, see the DYONICS POWER II Control System Operations/Service Manual (REF 10600181).
On/Off and Variable Modes
Blade Window Lock sets the stop position of the inner blade relative to the opening at the top of the outer blade. Press and hold the Window Lock button on the footswitch to rotate the blade. When the blade is in the best stopping position for the procedure, release the Window Lock button.
Lavage The DYONICS POWER II footswitch Lavage button works only with the DYONICS 25 Fluid Management System. In addition, the footswitch Lavage button will work only when: 1. The footswitch and DYONICS 25 control unit are assigned to the same port, and 2. The DYONICS POWER II Control Unit and DYONICS 25 control unit are connected to each other via the DYONICS 25 Shaver Interface Cable (REF 91000973). For information about the DYONICS POWER II Control Unit, read that product’s Operations/Service Manual (REF 10600181). For more information about the DYONICS 25 Fluid Management System, read that product’s Opera- tions/Service Manual (REF 1061600).
Cleaning
The DYONICS POWER II Footswitch operates in either the On/Off or Variable mode.
Follow this procedure after each operation to clean the footswitch:
On/Off will set the footswitch pedals to switch operation. Depressing the pedal causes the handpiece to operate at full set speed. Releasing the pedal turns the handpiece off.
1. Disconnect the footswitch cable from the control unit. 2. Wipe the footswitch and footswitch cable with a clean damp cloth (and mild germicide or isopropyl alcohol).
Variable will set the footswitch pedals to adjust the handpiece speed based on pedal pressure, much like the gas pedal in a car. The Left, Right and Oscillate pedals each will vary set speed between 0-100%, depending upon the pressure applied to the pedal. Maximum pressure provides 100% of set speed. Zero pressure stops the device.
3. Dry the cable connector completely before connecting to the control unit footswitch connector port.
DYONICS™ POWER II Footswitch
Instructions for Use
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Follow instructions for use • Gebrauchsanweisung befolgen • Siga el Modo de empleo. • Suivre le mode d’emploi • Seguire le istruzioni per l’uso • Följ bruksanvisningen • Volg de gebruiksaanwijzing • Seguir as instruções de utilização • Følg brugsanvisningen • Følg bruksanvisningen • 사용 지침을 따르십시오.
Catalog Number • Best.-Nr. • N.° de catálogo • No de référence de catalogue • N. di catalogo • Katalognummer • Catalogusnummer • Número de catálogo • Katalognummer • Katalognummer • 카탈로그 번호
Follow instructions for use • Gebrauchsanweisung befolgen • Siga el Modo de empleo. • Suivre le mode d’emploi • Seguire le istruzioni per l’uso • Följ bruksanvisningen • Volg de gebruiksaanwijzing • Seguir as instruções de utilização • Følg brugsanvisningen • Følg bruksanvisningen • 사용 지침을 따르십시오.
CE Mark • CE-Zeichen • Marca CE • Marque CE • Marchio CE • CE-märkning • CE-markering • Marca CE • CE-mærke • CE-merke • CE 마크
Non-sterile • Unsteril • No esterilizado • Non stérile • Non sterile • Osteril • Niet-steriel • Não esterilizado • Usteril • Usteril • 비살균
Oscillate pedal • Pedal zum Oszillieren • Pedal de oscilación • Pédale d’oscillation • Pedale oscillazione • Oscillerande pedal • Pedaal voor oscilleren • Pedal oscilante • Oscillationspedal • Oscillasjonspedal • 진동 페달
Watertight equipment per IEC 60529 • Wasserdichte Geräte gemäß IEC 60529 • Equipo estanco de conformidad con IEC 60529 • Matériel étanche conforme à la norme CEI 60529 • Apparecchiatura a tenuta stagna a norma IEC 60529 • Vattentät utrustning i enlighet med IEC 60529 • Waterdichte uitrusting volgens IEC 60529 • Equipamento estanque, segundo a norma IEC 60529 • Vandtæt udstyr ifølge IEC 60529 • Vanntett utstyr i henhold til IEC 60529 • IEC 60529에 따른 방수 기구
Lavage • Spülen • Lavado • Lavage • Lavaggio • Sköljning • Spoelen • Lavagem • Udskylning • Skylling • 세정
Serial Number • Seriennummer • N.° de serie • No de série • N. di serie • Serienummer • Serienummer • Número de série • Serienummer • Serienummer • 일련 번호
Manufacturer • Hersteller • Fabricante • Fabricant • Produttore • Tillverkare • Fabrikant • Fabricante • Producent • Produsent • 제조업체
Authorized representative in the European community • Bevollmächtigter Vertreter in der europäischen Gemeinschaft • Representante autorizado en la Comunidad Europea • Représentant agréé dans l’Union européenne • Rappresentante autorizzato nella Comunità Europea • Auktoriserad representant i EU • Bevoegd vertegenwoordiger in de Europese Gemeenschap • Representante autorizado na Comunidade Europeia • Autoriseret repræsentant i EU • Autorisert representant i Den europeiske union • 유럽 공동체 공인 대리점
Blade window lock - adjustment of cutting window stop position • Klingenfenster verriegeln – Einstellen der Stopp-Position des Schneidefensters • Bloqueo de la ventana de la hoja – ajuste de la posición de parada de la ventana de corte • Verrouillage de la fenêtre de la lame – réglage de la position d’arrêt de la fenêtre de coupe • Blocco finestra lama – regolazione della posizione di arresto della finestra di taglio • Bladlås – justering av skärfönstrets stopplägen • Vergrendeling bewegingsruimte mes - aanpassing van de stoppositie van de snijruimte • Bloqueio da janela da lâmina - regulação da posição de paragem da janela de corte • Bladvindueslås - justering af det skærende vindues stop-position • Bladets vinduslås – justering av skjærevinduets stopposisjon • 날 창 잠금 - 절제되는 창의 정지 위치 조정
Left pedal • Linkes Pedal • Pedal izquierdo • Pédale gauche • Pedale sinistro • Vänster pedal • Linkerpedaal • Pedal esquerdo • Venstre pedal • Venstre pedal • 좌측 페달
Right Pedal • Rechtes Pedal • Pedal derecho • Pédale droite • Pedale destro • Höger pedal • Rechterpedaal • Pedal direito • Højre pedal • Høyre pedal • 우측 페달
EU: Not for general waste • EU: Nicht für den Hausmüll vorgesehen • UE: No apto para residuos generales • UE : Ne pas déposer dans la poubelle générale • UE. Da separare dai rifiuti generali • EU: Får ej kasseras med allmänt avfall • EU: Niet voor algemeen afval • UE: Não se pode eliminar juntamente com os resíduos normais • EU: Ikke til almindeligt affald • EU: Skal ikke avhendes med vanlig avfall • EU: 특수 폐기물
Date of manufacture • Herstellungsdatum • Fecha de fabricación • Date de fabrication • Data di fabbricazione • Tillverkningsdatum • Fabricagedatum • Data de fabrico • Fremstillingsdato • Produksjonsdato • 제조일자
Lot number • Chargennummer • N° de lote • N° de lot • Numero di lotto • Lot-nummer • Lotnummer • Número de lote • Lotnummer • Partinummer • 제조 일련번호
Temperature limitation • Zulässiger Temperaturbereich • Limitación de temperature • Limitation de température • Limitazione della temperatura • Temperaturbegränsning • Temperatuurgrenzen • Limitação da temperatura • Temperaturbegrænsning • Temperaturbegrensning • 온도 제한 범위
Humidity limitation • Feuchtigkeitsbereich • Limitación de humedad • Limite d’humidité • Limite di umidità • Luftfuktighetsbegränsning • Vochtigheidslimiet • Limite de humidade • Fugtighedsbegrænsning • Fuktighetsgrense • 습도 제한
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
Smith & Nephew Orthopaedics GmbH Alemannenstraße 14 78532 Tuttlingen Germany [email protected]
www.smith-nephew.com +1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service
©2007, 2018 Smith & Nephew, Inc. All rights reserved. 11/2018 10600267 Rev. E