Arthrex

Arthroscopy Pumps

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Arthrex Continuous Wave™ III Arthroscopy Pump - Set Up and Operation 2 1 Following removal of the orange cap, the pressure line connector is plugged into the tubing sensor coupler located on the lower left corner of the front panel... The roller housing door is lifted and the tubing is loaded around the pump rollers... he green color-coded connector on the tubing set is matched with the green dot on the tubing guide to ensure proper orientation... he spikes are then inserted into the irrigation bags... 3 Power is applied to the console by pressing the power switch in the upper right corner of the front panel... he pressure and flow levels are adjusted, either by the circulating nurse or from the sterile field using the autoclavable remote control (not shown)... he pump is activated by pressing the Run/Stop button... Suggested Initial Pressure Settings with Flow Rate at 100% (default) The settings listed below are based on the use of a high-flow sheath or secondary inflow portal (suprapatellar, etc... Knee Arthroscopy - 35 mmHg Shoulder Arthroscopy - 5O mmHg Small Joint Arthroscopy - 40 mmHg Hip Arthroscopy - 45 mmHg The safety and efficacy of fluid pumps are well documented, but users should be cautioned about the possibility of fluid extravasation in patients with compromised joint capsules due to pathology or procedures which open the capsule (e... , lateral release)... t is strongly suggested that minimum effective pressures be used to achieve the desired joint distention... ressure and flow levels may be adjusted at the console by the circulating nurse, or by the surgeon or surgical assistant in the sterile field using the remote control... roper operation of this device requires the establishment of adequate fluid outflow... arefully monitor the outflow and assess the patient regularly to avoid extravasation or any other adverse patient condition... or more information, consult the console’s User's Guide and the Directions For Use card supplied with the accessory tubing sets... or additional assistance using this product, please call: Arthrex Tech Support Hotline at 1-888-420-9393, Monday - Friday, 9:00 am to 5:00 pm EST Arthrex GmbH at +49 89 909005-0 or techsupport@arthrex... from 8:00 am to 5:00 pm CET DFU-0219 Rev... 1370 Creekside Boulevard, Naples, Florida 34108-1945 • 800-934-4404 • Fax: 800-643-9310 • www... threx... m Troubleshooting Arthrex Technical Support should be informed immediately in the event of any damage or malfunction in the equipment... ttempt the remedies listed below and in the User's Guide of the Operating Instruction Manual in the order in which they are presented... OMMON PROBLEMS AND REMEDIES: PROBLEM SOLUTION * Check Tube * 1... Console fails Self Diagnostic Test 1... nsure no tubing is connected to the pump during power on sequence... eturn to Arthrex for repair... Console won’t power up 1... Check AC mains power cord... ry alternate power outlet... heck AC main fuses... eturn to Arthrex for repair... Doesn't pump when activated 1... Open all tubing clamps and shut off valves... nsure actual pressure is below target pressure... heck if the tubing is pinched, kinked, or blocked... heck whether the pressure sensor plug is seated completely and correctly... eturn to Arthrex for repair... * Door Not Closed * 1... oller Housing not secured – ensure locking lever is properly secured... eturn to Arthrex for repair... Inadequate Distention, liquid bloody or cloudy 1... Increase pressure... ctivate Flush Mode... educe outflow... se high-flow cannulas... No (or inadequate) flow 1... Check that all tubing clamps are open... heck the settings for flow and pressure... heck if the tubing is pinched, kinked or blocked... ecure the roller housing door... heck that tubing seats correctly over the rollers... erify use of high-flow cannulas... f failure remains, return to Arthrex for repair... * Overpressure * 1... ncrease outflow... anipulate joint to stress-free position... * Pressure Fault * 1... If tubing sensor indicator’s LED is red, tubing is not properly connected... nsure tubing sensor coupler is open... nsure that the tubing pressure plug is seated completely... hange tubing... eturn to Arthrex for repair... Ensure adequate fluid supply... ecrease outflow... heck the tubing for damage and if it is pinched, kinked, or blocked... heck tubing for proper connections... eplace tubing... f failure remains, return to Arthrex for repair...

Arthrex Continuous Wave III Arthroscopy Pump - Set Up and Operation Quick Guide Rev 0

Arthrex Continuous Wave III Arthroscopy Pump - Set Up and Operation 2 1 Following removal of the orange cap, the pressure sensor line is plugged into a snap-fit connection located on the lower left corner of the front panel... The roller housing door is lifted and the tubing is loaded around the pump rollers... he green color-coded connector on the tubing set is matched with the green dot on the tubing guide to ensure proper orientation... he spikes are then inserted into the irrigation bags... 3 Power is applied to the console by pressing the power switch in the upper right corner of the front panel... he pressure and flow levels are adjusted, either by the circulating nurse or from the sterile field using the autoclavable remote control... he pump is activated by pressing the Run/Stop button... Suggested Initial Pressure Settings with Flow Rate at 100% (default) The settings listed below are based on the use of a high-flow sheath or secondary inflow portal (suprapatellar, etc... Knee Arthroscopy - 35 mmHg Shoulder Arthroscopy - 5O mmHg Small Joint Arthroscopy - 35 mmHg Hip Arthroscopy - 35 mmHg The safety and efficacy of fluid pumps are well documented but users should be cautioned about the possibility of fluid extravasation in patients with compromised joint capsules due to pathology or procedures which open the capsule (e... , lateral release)... t is strongly suggested that minimum effective pressures be used to achieve the desired joint distention... ressure and flow levels may be adjusted at the console by the circulating nurse, or by the surgeon or surgical assistant in the sterile field using the remote control... roper operation of this device requires the establishment of adequate fluid outflow... arefully monitor the outflow and assess the patient regularly to avoid extravasation or any other adverse patient condition... or more information, consult the console’s User's Guide and the Directions For Use card supplied with the accessory tubing sets... or additional assistance in using this product, please call the Arthrex Tech Support Hotline at 1-888-420-9393, Monday - Friday, 9:00 am to 5:00 pm EST... 1370 Creekside Boulevard, Naples, Florida 34108-1945 • 800-934-4404 • Fax: 800-643-9310 • www... threx... m LM1-0604-EN_B Troubleshooting Arthrex Technical Support should be informed immediately in the event of any damage or malfunctions in the equipment... ttempt the remedies listed below and in the User's Guide of the Operating Instruction Manual in the order in which they are presented... PROBLEM SOLUTION COMMON PROBLEMS AND REMEDIES: * Check Tube * Console won’t power up Console fails Self Diagnostic Test 1... ncrease outflow... ncrease pressure... 1... 1... nsure no tubing is connected to the pump during power on sequence... eturn to Arthrex for repair... Tubing sensor indicator not seated... nsure that the tubing pressure plug is seated completely... hange tubing... eturn to Arthrex for repair... 1... Distention liquid bloody or cloudy Open all tubing clamps and shut-off valves... nsure actual pressure is below target pressure... heck if the tubing is pinched, kinked, or blocked... heck whether the pressure sensor plug is seated completely and correctly... eturn to Arthrex for repair... Check AC mains power cord... ry alternate power outlet... heck AC mains fuses... eturn to Arthrex for repair... Doesn't pump when activated 1... 1... oller Housing not secured – ensure locking lever is properly secured... eturn to Arthrex for repair... Inadequate pressure 1... ncrease pressure... educe outflow... se high-flow cannulas... * Door Not Closed * No (or inadequate) flow * Overpressure * 1... ncrease outflow... anipulate joint to stress-free position... Check that all tubing clamps are open... heck the settings for flow and pressure... heck if the tubing is pinched, kinked or blocked... ecure the roller housing door... heck that tubing seats correctly over the rollers... erify use of high-flow cannulas... f failure remains, return to Arthrex for repair... 1... * Pressure Fault * Ensure adequate fluid supply... ecrease outflow... heck the tubing for damage and if it is pinched, kinked, or blocked... heck tubing for proper connections... eplace tubing... f failure remains, return to Arthrex for repair... 1...

Arthrex Continuous Wave III Arthroscopy Pump - Set Up and Operation Quick Guide Rev B

Safety test Quick guide This is the “clamp test” for the main pump tubing set-up on the Arthrex Continuous Wave & DualWave Arthroscopic Pump (AR-6450, AR-6475, AR-6480) I II III IV 1... et up the pump tubing... ) First remove the protection cap ( I – IV )... b) Insert the connector fitting of the Pump Tubing into the Tubing Sensor Coupler... his step must be completed first to ensure accurate pressure measurements... ) Release the locking lever of the roller housing door and open the door completely... llow the door to rest against the stop... he roller mechanism is now exposed... green dot d) Place the green-collared section of the Pump Tubing into the Tubing IN Guide indicated by the green dot... ) Guide the tubing boot over the rollers and insert the output side of the tubing boot into the Tubing OUT Guide... locking lever AR-6475 NOTE: The Pump Tubing is connected properly when the green connector on the Main Pump Tubing is aligned with the green dot on the front panel of the console... ) Close and lock the roller housing door... ) Connect the tubing spikes to an bag... 2... After adjusting the required pressure using the Pressure Set buttons, remove the cap from the patient end of the tubing... R-6480 green dot www... threx... m 3... ssure that all appropriate tubing clamps are open... Activate the pump motor by pressing the ON/OFF button... R-6450 AR-6475 AR-6480 5... At the beginning of the pumping procedure the mem­ brane must be filled with air... ill the entire length of the tubing with fluid to remove any air bubbles... embrane Sensor Chamber NOTE: It is not necessary to remove the air within the Sensor Chamber on the Pump Tubing Set... 6... After the air has been purged from the tubing, close the clamp at the patient end of the tubing... he Sensor Chamber must not be filled completely... enerally the top water level is at ⅓ Chamber height... The rollers must stop turning, and interrupt the pumping procedure immediately... his is a safety check to ensure that the sensor system is working properly... ■■If the rollers do not stop, ensure clamp is firmly closed... ■ If the rollers turn continuously, the connector fitting may not be functioning properly... Replace the Pump Tubing... n case of continuing failure, please contact your sales representative and return the pump for investigation to Arthrex... o achieve the maximum patient safety, we would like to ask you to run this test prior to every use... Arthrex GmbH | tel + 49 89 90 90 05 0 | fax + 49 89 90 90 05 2801 | info@arthrex... | www... threx... m © Arthrex GmbH, 2015... ll rights reserved... IT2-516-EN_C www... threx... m

Model AR- 6400 series Continuous Wave & DualWave Safety Test Quick Guide Rev C

Table of contents 1... General Warnings and Safety Notices - Read This First ... 1 1... Important Safety and Conventions Information ... 1 1... Symbols Definition ... 5 1... Shipping, Unpacking and Warranty Information ... 2... Product Description ... 7 2... Product Description and Intended Use ... 7 2... Product Features... 9 2 ... AR-6475 Console: Front View ... 9 22 ... AR-6475 Console: Rear View ... 0 2 ... AR-6475 Vacuum Fluorescent Display Messages ... 11 2 ... Measured Pressure Bar Graph ... 12 2... Remote Control Unit (AR-6476) ... 13 2... Tubing ... 14 2 ... Tubing Configurations ... 4 2 ... Main Pump Tubing Set (AR-6410: Region A) ... 6 2... 3 Extension Tubing System (AR-6220: Region A) ... 16 2... 4 ReDeuce™ Pump Tubing Set (AR-6411: Region A) ... 16 2... 5 ReDeuce Patient Tubing (AR-6421: Region A) ... 16 2... 6 One Piece Tubing Set System (AR-6415/AR-6415CL: Region B) ... 16 2... 7 Main Pump Tubing Set (AR-6420/AR-6420CL: Region B) ... 17 2... 8 Patient Extension Tubing System (AR-6425: Region B) ... 17 2... 9 Y-Adapter Tubing (AR-6215) ... 17 3... Technical Specifications ... 19 3... Console ... 19 3... Remote Control ... 19 4... Setup ... 0 4... How to Set Up the Console ... 20 4... AC Power Safety Considerations ... 20 4... Replacing the Fuses ... 1 4... Electromagnetic Compatibility ... 21 4... Basic Setup Procedure for the AR-6475 ... 2 4... How to Set Up Main Pump Tubing ... 3 4... How to Set Up the Two-Piece Tubing System ... 4 DFU-0218 Rev... Page i

Model AR-6475 Continuous System III User’s Guide Rev 1

Quick guide DualWave Pump ‑ Software version 1... | Overview Please see notes section for shaver settings! Inflow Side Power 1 Ensure shaver console to power-on prior to pump... onnect all accessories (handpiece, footswitch) to shaver... witch shaver on... Footswitch/ Remote Port Outflow Side 2 Power on DualWave... 3 Pump will display menu...

Model AR-6480 DualWave Arthroscopy Pump Quick Guide Rev A Sw Ver 1.7

Troubleshooting PROBLEM SOLUTION ** Tubing Out ** 1... ubing sensor indicator not seated 2... nsure that the tubing pressure plug is seated completely 3... hange tubing * Return to Arthrex for repair Console fails Self Diagnostic Test 1... nsure no tubing is connected to the pump during power on sequence * Return to Arthrex for repair Console will not power up 1... heck AC main power cord 2... ry alternate power outlet 3... heck AC main fuses * Return to Arthrex for repair Lack of distention liquid bloody/cloudy Does not pump when activated ** Door Open ** Inadequate pressure No/Low Flow To Adjust the Shaver Detection Settings: 1... ctivate LAVAGE mode 2... ncrease pressure 3... ecrease outflow 1... heck for error messages 2... pen all tubing clamps and shut-off valves 3... nsure actual pressure is below target pressure 4... heck if the tubing is pinched, kinked, or blocked * Return to Arthrex for repair 1... ress the MENU Button 2... ress the DEFAULTS Button 3... ress the SHAVER Button 4... hoose alternate DETECTION FILTER setting 5... ress DONE to save changes 1... oller housing not secured – ensure locking lever is properly secured * Return to Arthrex for repair 1... ncrease pressure... ctivate LAVAGE mode 3... educe outflow 4... se high-flow cannulas 1... heck for error messages 2... heck that all tubing clamps are open 3... heck the settings for flow and pressure 4... heck if the tubing is pinched, kinked or blocked 5... heck that tubing seats correctly over the rollers 6... erify use of high-flow cannulas 7... f failure remains, return to Arthrex for repair ** Overpressure ** 1... ncrease or open outflow 2... anipulate joint to stress-free position ** Pressure Fault ** 1... nsure adequate fluid supply 2... ecrease outflow 3... heck tubing for damage and if it is pinched, kinked or blocked 4... heck tubing for proper connections 5... eplace tubing 6... f failure remains, return to Arthrex for repair No Shaver Detection Arthrex DualWave Set-up and Operation 1... nsure universal shaver cable is connected 2... urn on and off DualWave while the shaver system is powered on 3... hange SHAVER DETECTION PRESET to alternate setting 4... solate the power source 5... f failure remains, return to Arthrex for repair ©2013, Arthrex Inc... ll rights reserved... M1-0625-EN_B http://www... threx... m/imaging-resection/fluid-management Arthrex DualWave Set-Up and Operation INFLOW Remove orange cap from inflow tubing Insert connector into pump Open inflow door Insert green tubing hub Wrap tubing around the roller Ensure both hubs are fully seated Close inflow door OUTFLOW Open outflow door Place tubing loop over the roller Slide cassette into place Close outflow door SHAVER DETECTION 1... ress the MENU Button Turn on shaver console Plug in handpiece Power on DualWave Choose correct joint space 1... ress the MENU Button Press RUN button The safety and efficacy of fluid pumps are well documented but users should be cautioned about the possibility of fluid extravasation in patients with compromised joint capsules due to pathology or procedures which open the capsule (i... lateral release)... t is strongly suggested that minimal effective pressures be used to achieve the desired joint distention... ressure and suction levels may be adjusted at the console or from the sterile field using a remote control... roper operation of the device requires the establishment of adequate fluid outflow... arefully monitor the outflow and assess the patient regularly to avoid extravasation or any other adverse patient condition... roperly place the pump on a dry flat surface at the same horizontal plane as the operative site... or more information consult the User’s Guide and the Directions For Use card supplied with the accessory tubing sets... or additional support, call the Arthrex Tech Support Hotline: 1-888-420-9393

Model AR-6480 DualWave Arthroscopy Pump Troubleshooting Guide Rev B

Table of contents 1... General Warnings and Safety Notices - Read This First ... 1 1... Important Safety Conventions ... 1... Symbols Definition ... 4 1... Shipping, Unpacking, and Warranty Information ... 6 2... Product Description ... 2... Product Description and Intended Use... 7 2... Product Features... 9 2... 1 AR-6480 Console: Front View ... 2... 2 AR-6480 Console: Rear View ... 10 2... 3 AR-6480 Operator Display Messages and Iconography ... 11 2... Foot Pedal Unit (AR-6483) ... 3 2... Remote Control Unit (AR-6482) ... 14 2... Tubing ... 15 2... 1 Tubing Configurations ... 15 2... 2 Main Pump Tubing Set (AR-6410: Region A) ... 2... 3 ReDeuce™ Pump Tubing Set (AR-6411: Region A) ... 8 2... 4 ReDeuce Patient Tubing Set (AR-6421: Region A) ... 2... 5 Extension Tubing System (AR-6220: Region A)... 18 2... 6 One-Piece Tubing Set System (AR-6415/AR-6415CL: Region B) ... 18 2... 7 Main Pump Tubing Set (AR-6420/AR-6420CL: Region B) ... 8 2... 8 Patient Extension Tubing System (AR-6425: Region B) ... 19 2... 9 Outflow Pump Tubing Set (AR-6430) ... 2... 10 Outflow Tub set with ReDeuce Tubing System (AR-6435: Region A) ... 19 2... 11 Y-Adapter Tubing (AR-6215) ... 3... Technical Specifications ... 1 3... Console ... 21 3... Foot Pedal ... 22 3... Remote Control ... 22 3... Safety, EMC, and Regulatory Requirements... 2 4... Setup ... 23 4... How to Set Up the Console ... 23 4... AC Power Safety Considerations ... 23 4... Replacing the Fuses ... 4 DFU-0212 Rev... Page i

Model AR-6480 DualWave Arthroscopy Pump Users Guide Rev 1 Feb 2012

DualWave   Arthroscopy  Pump     AR-­‐‑6480   User’s  Guide   The  Arthrex  DualWave  Arthroscopy  Pump  User’s  Guide  provides   safety  operation  information  for  all  components  of  the  Arthrex   DualWave  Arthroscopy  Pump  (Model  AR-­‐‑6480),  including   accessories... All  operating  personnel  must  read  this  User’s  Guide  for   version  1...  thoroughly  prior  to  using  this  system  and  follow  all   safety  warnings,  cautions,  and  precautions... U...  PATENT  No... 5,520,638   0086     Arthrex,  Inc... Naples,  FL  34108-­‐‑1945  USA   Toll  Free:  800  934-­‐‑4404   www... threx... m     Arthrex  Med... Inst... GmbH   85757  Karlsfeld,  Germany   Telephone:  49  81  31  59  57  290   www... threx...   LM2-­‐‑0630-­‐‑EN_E   ©  2012  Arthrex,  Inc... All  rights  reserved...     Table  of  contents   1...   Read This First ... 1   1...   Important Safety Information ...   1...   Important Symbols and Conventions ... 2   1...   Shipping, Unpacking and Warranty Information ... 4   2...   Product Description ... 5   2...   Product Description and Intended Use...   2...   Product Features ...   2... 1   AR-6480 Console: Front View ... 6   2... 2   AR-6480 Console: Rear View ... 7   2... 3   AR-6480 Display Messages ... 8   2...   Foot Pedal Unit (AR-6483) ... 10   2...   Remote Control Unit (AR-6482) ... 11   2...   Tubing ... 12   2... 1   Tubing Configurations ... 2   2... 2   Tubing: AR-6415 ... 14   2... 3   Tubing: AR-6220 ... 15   2... 4   Tubing: AR-6420 ... 15   2... 5   Tubing: AR-6425 ... 15   2... 6   Tubing: AR-6215 ... 15   2... 7   Tubing: AR-6430 ... 15   3...   Technical Specifications ... 16   3... 1   Console ... 16   3... 2   Foot Pedal ... 6   3... 3   Remote Control ... 17   4...   Setup ... 8   4...   How to Set Up the Console ... 8   4...   AC Power Safety Considerations ... 8   4...   Replacing the Fuses... 19   4...   Electromagnetic Compatibility ... 19   4...   Basic Setup Procedure for the AR-6480 ... 19   4...   Shaver Detection ... 20   4... 1   Shaver Detect, Inflow only ... 0   LM2-­‐‑0630-­‐‑EN_E   Page  i  

Model AR-6480 DualWave Arthroscopy Pump Users Guide Rev E

DFU-0144 Revision 3 Remote Controls Fernbedienungen Télécommandes Telecomandi Unidades de control remoto IMPORTANT PRODUCT INFORMATION WICHTIGE PRODUKTINFORMATION NOTICE D’UTILISATION IMPORTANTE IMPORTANTI INFORMAZIONI PER L’USO INSTRUCCIONES IMPORTANTES PARA EL USO Arthrex, Inc... aples, FL 34108-1945 • USA Toll free: +1 800 934-4404 www... threx... m Do not reuse Nicht wiederverwenden! Ne pas réutiliser Monouso No reutilizar Manufacturer Hersteller Fabricant Produttore Fabricante ENGLISH A... ESCRIPTION The autoclavable Remote Control Units can operate the AR-6400 series Arthroscopy Pumps... he AR-6476 cannot be used with the AR-6480, Dual Wave Arthroscopy Pump... he AR-6480 uses the Dual Wave remote control (AR-6482) instead... he Remote Control Unit lets you adjust the settings from a maximum distance of 9... feet (3 meters) from the control unit of the pump... ote: The Run/Stop and Flush functions are inoperable in the original Continuous Wave Pump and Continuous Wave Pump II... ARNINGS 1... o not disconnect the remote control by pulling on the cable... emove the remote control plug by grasping the body of the connector... EVER use liquid to clean the connector contacts of the remote control connector... emove dust regularly with dry compressed air... 0086 Catalog number Bestellnummer Référence catalogue Numero di catalogo Número de catálogo DFU-0144r3 Arthrex Med... nst... mbH 85757 Karlsfeld • Germany Tel: +49 81 31 59 57 0 www... threx... Quantity Quantität Quantité Quantità Cantidad Non sterile Nicht steril Non stérile Non sterile No estéril Contains phthalates Enthält Phthalate Contient des phthalates Contiene ftalati Contiene ftalatos Authorized Representative in the European Community Bevollmächtigter in der Europäischen Gemeinschaft Mandataire dans la Communauté européenne Mandatario nella Comunità Europea Representante autorizado en la Comunidad Europea Lot number Chargenbezeichnung No... e lot Numero di lotto Número de lote See instructions for use Bitte Gebrauchsanweisung beachten Lire attentivement la notice d’utilisation Leggere attentamente il foglio illustrativo Ver instrucciones de uso SN Serial Number Serial number Seriennummer Numéro de série Numero de serie Electronic Waste Elektronischer Abfall Déchet électronique Rifiuti elettronici Desperdicio electrónico The product meets the essential requirements of Medical Device Directive 93/42 EEC... as Produkt entspricht den grundlegenden Anforderungen der Richtlinie des Rates über Medizinprodukte 93/42/EWG... e produit est conforme aux exigences de la directive sur les dispositifs médicaux CEE 93/42... l prodotto è conforme ai requisiti essenziali della Direttiva CEE 93/42 sui Dispositivi Medici... ste producto cumple con las normas básicas de la Directiva de productos médicos, 93/42 CEE... aution: Federal law (USA) restricts this device to sale by or on the order of a physician... CHTUNG: Gemäß der gesetzlichen Bestimmungen (USA) darf dieses Produkt nur durch einen Arzt oder auf Grund einer ärztlichen Verordnung verkauft werden... ise en garde : la loi fédérale des états-unis limite la vente de ce dispositif par un médecin ou sur l’ordonnance d’un médecin... ttenzione: le leggi federali (USA) autorizzano la vendita di questo dispositivo esclusivamente da parte di un medico o dietro sua prescrizione... recaución: la ley federal (estados unidos) restringe la venta de este aparato a médicos, o bajo las órdenes de éstos... DEUTSCH DFU-0144r3 A... ESCHREIBUNG Diese autoklavierbaren Fernbedienungseinheiten sind für den Betrieb der Arthroskopiepumpen Serie AR-6400 vorgesehen... ie AR-6476 ist nicht für die AR-6480 Dual Wave Arthroskopiepumpe geeignet... as Modell AR-6480 arbeitet statt dessen mit der Dual Wave Fernbedienung (AR-6482)... it der Fernbedienungseinheit können Sie aus maximal 3 m Entfernung zur Pumpe die Einstellungen vornehmen... inweis: Die Lauf/Stopp- und Spül-Funktionen stehen bei der ursprünglichen Kontinuierlichen Wave Pumpe und Kontinuierlichen Wave Pumpe II nicht zur Verfügung... ARNHINWEISE 1... icht am Kabel ziehen, um die Fernbedienung vom Gerät abzutrennen... um Abtrennen der Fernbedienung den Stecker am Steckergehäuse festhalten... ie Fernbedienungsanschlusskontakte KEINESFALLS mit Flüssigkeit reinigen... taub regelmäßig mit Druckluft entfernen... C... LEANING AND DISINFECTION The Remote Control can be cleaned and disinfected using commercially available surface disinfectants... lways comply with the instructions issued by the manufacturers of the cleaners and disinfectants... C... EINIGUNG UND DESINFEKTION Die Fernbedienung kann mit im Handel erhältlichen Oberflächendesinfektionsmitteln gereinigt und desinfiziert werden... tets die von den Herstellern der Reinigungs- und Desinfektionsmittel herausgegebenen Anweisungen beachten... D... ACKAGING AND LABELING 1... rthrex devices should be accepted only if the factory packaging and labeling arrive intact... ontact Customer Service if the package has been opened or altered... D... ERPACKUNG UND KENNZEICHNUNG 1... rthrex Produkte sollten nur entgegengenommen werden, wenn Verpackung und Kennzeichnung unbeschädigt sind... nformieren Sie den Kundendienst, wenn die Verpackung zuvor geöffnet oder verändert wurde... E... TERILIZATION This device is provided non-sterile and can be sterilized... t is designed to survive a minimum 300 cycles of steam sterilization in an autoclave... t must be adequately cleaned, then sterilized using one of the following sterilization parameters... his unit is NOT designed for submersion or chemical sterilization... ollow your country-specific guidelines, standards, and requirements... E... TERILISATION Dieses Produkt wird unsteril geliefert und kann sterilisiert werden... as Produkt ist so konzipiert, dass es mindestens 300 Dampfsterilisationszyklen in einem Autoklaven übersteht... s muss entsprechend gereinigt und dann anhand der folgenden Parameter sterilisiert werden... ie Einheit ist NICHT für Sterilisation durch Eintauchen oder Chemikalien vorgesehen... ie länderspezifischen Richtlinien, Normen und Anforderungen befolgen... STERILIZATION PARAMETERS: FOR THE USA ONLY: Exposure Exposure Drying Temperature Time Time Gravity-Displace- 121°C (250°F) 30 Minutes 15 to 30 Minutes ment Steam Ster- 132°C (270°F) 15 Minutes 15 to 30 Minutes ilization Cycle 135°C (275°F) 10 Minutes 30 Minutes 132°C (270°F) 4 Minutes 20 to 30 Minutes Pre-vacuum Cycle 135°C (275°F) 3 Minutes 16 Minutes STERILIZATION PARAMETERS: FOR OUTSIDE THE USA ONLY: Exposure Exposure Drying Temperature Time Time Gravity-Displace- 132°C – 135°C 18 Minutes 15 to 30 Minutes ment Steam Ster- (270°F – 275°F) ilization Cycle 121°C (250°F) 30 Minutes 15 to 30 Minutes 132°C - 135°C Pre-vacuum Cycle 4 Minutes 20 to 30 Minutes (270°F - 275°F) Certain Arthrex instruments that may be used during this procedure are provided non-sterile and must be adequately cleaned and sterilized prior to use or re-use... lease refer to DFU-0023 and ANSI/AAMI ST79, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities” for specific information... terilizers vary in design and performance characteristics... ycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions... ooling – The device must be adequately cooled, after being removed from the sterilizer... fter autoclave sterilization, the device must be fully dry before use... TORAGE CONDITIONS Products must be stored in the original unopened packaging, away from moisture... NFORMATION Surgeons are advised to review the product specific surgical technique prior to performing any surgery... rthrex provides detailed surgical techniques in print, video, and electronic formats... he Arthrex website also provides detailed surgical technique information and demonstrations... r, contact your Arthrex representative for an onsite demonstration... STERILISATIONSPARAMETER: NUR FÜR USA: Sterilisations- Sterilisations- Trocknungstemperatur dauer dauer Gravitations- 121°C (250°F) 30 Minuten 15 bis 30 Minuten V e r f a h r e n 132°C (270°F) 15 Minuten 15 bis 30 Minuten Dampf-Sterili10 Minuten 30 Minuten sations-Zyklus 135°C (275°F) Prävakuum- 132°C (270°F) Zyklus 135°C (275°F) 4 Minuten 3 Minuten 20 bis 30 Minuten 16 Minuten STERILISATIONSPARAMETER: NUR AUSSERHALB DER USA: Sterilisations- Sterilisations- Trocknungstemperatur dauer dauer Gravitations- 132°C – 135°C 18 Minuten 15 bis 30 Minuten V e r f a h r e n (270°F – 275°F) Dampf-Sterili30 Minuten 15 bis 30 Minuten sations-Zyklus 121°C (250°F) Pr ä v a k u u m - 132°C - 135°C 4 Minuten 20 bis 30 Minuten Zyklus (270°F - 275°F) Bestimmte, während dieses Eingriffs verwendete Arthrex Instrumente werden unsteril geliefert und müssen vor Gebrauch bzw... iederverwendung ordnungsgemäß gereinigt und sterilisiert werden... iehe hierzu bitte DFU-0023 und ANSI/AAMI ST79, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities” (Umfassende Informationen zu Dampfsterilisation und Sterilisationsprüfung in klinischen Einrichtungen) für weitere Informationen... terilisiergeräte variieren im Design und in den Leistungseigenschaften... eshalb sollten die Ablaufparameter immer mit den Herstelleranweisungen des speziellen Sterilisiergerätes und dessen Ladungseinstellungen überprüft/validiert werden... bkühlung – Das Produkt muss nach der Entnahme aus dem Sterilisator genügend abkühlen... ach der Sterilisation im Autoklaven muss das Gerät vollständig trocken sein, ehe es verwendet wird... AGERUNGSBEDINGUNGEN Produkte sind in der ungeöffneten Originalverpackung vor Feuchtigkeit geschützt aufzubewahren... NFORMATIONEN Chirurgen wird angeraten, sich vor der Durchführung von Operationen mit den produktspezifischen Operationstechniken vertraut zu machen... rthrex stellt detaillierte Operationstechniken in gedruckter Form, als Video oder in elektronischem Format bereit... udem sind auf der Arthrex Website detaillierte Informationen und Vorführungen zur Operationstechnik zu finden... ie können sich jedoch auch mit dem zuständigen Arthrex Produktspezialisten zwecks einer Produktvorführung vor Ort in Verbindung setzen... FRANÇAIS DFU-0144r3 A... ESCRIPTION Les télécommandes autoclavables permettent de commander le fonctionnement des pompes arthroscopiques de la gamme AR-6400... a télécommande AR-6476 ne peut pas être utilisée avec la pompe arthroscopique à double débit AR-6480... a pompe AR-6480 est par contre compatible avec la télécommande à double débit (AR-6482)... a télécommande permet de régler les paramètres depuis une distance maximale de 3 mètres (9,8 pieds) de la console de commande de la pompe... emarque : Les fonctions de marche/arrêt et de rinçage sont inopérantes avec la pompe à débit continu d’origine et avec la pompe à débit continu version II... ISES EN GARDE 1... e pas débrancher la télécommande en tirant sur le câble... etirer la prise de la télécommande en saisissant le corps du connecteur... E JAMAIS utiliser un liquide pour nettoyer les contacts du connecteur de la télécommande... es dépoussiérer régulièrement avec de l’air comprimé sec... ETTOYAGE ET DÉSINFECTION La télécommande peut être nettoyée et désinfectée au moyen de désinfectants de surface commerciaux... oujours se conformer aux instructions du fabricant du nettoyant ou du désinfectant... MBALLAGE ET ÉTIQUETAGE 1... es accessoires Arthrex ne doivent être acceptés que lorsque l’emballage et l’étiquetage d’origine sont intacts à la livraison... ontacter le Service Clients si l’emballage a été ouvert ou endommagé... TÉRILISATION Ce dispositif est livré non stérile et peut être stérilisé... l est conçu pour résister à un minimum de 300 cycles de stérilisation à la vapeur à l’autoclave... l doit être correctement nettoyé, puis stérilisé en utilisant l’un des ensembles de paramètres de stérilisation suivants... et appareil n’est PAS conçu pour supporter l’immersion ou la stérilisation chimique... e conformer aux directives, normes et exigences spécifiques de chaque pays... ARAMÈTRES DE STÉRILISATION : POUR LES QUEMENT : Température Temps d’exposition d’exposition C y c l e s d e 121°C (250°F) 30 minutes stérilisation 132°C (270°F) 15 minutes à la vapeur à déplacement 135°C (275°F) 10 minutes par gravité 4 minutes Cycles avec 132°C (270°F) pré-vide 135°C (275°F) 3 minutes ÉTATS-UNIS UNITemps de séchage 15 à 30 minutes 15 à 30 minutes 30 minutes 20 à 30 minutes 16 minutes PARAMÈTRES DE STÉRILISATION : EN DEHORS DES ÉTATS-UNIS UNIQUEMENT : Température Temps Temps d’exposition d’exposition de séchage C y c l e s d e 132°C – 135°C 18 minutes 15 à 30 minutes stérilisation (270°F – 275°F) à la vapeur à déplacement 121°C (250°F) 30 minutes 15 à 30 minutes par gravité Cycles avec pré-vide 132°C – 135°C (270°F – 275°F) 4 minutes 20 à 30 minutes Certains instruments Arthrex pouvant être utilisés au cours de cette procédure sont livrés non stériles et doivent être correctement nettoyés et stérilisés avant leur utilisation ou réutilisation... our des informations plus spécifiques, consulter les documents DFU-0023 et ANSI/AAMI ST79, « Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities »... es stérilisateurs peuvent varier dans leur conception et leurs caractéristiques de performances... es paramètres de stérilisation et la configuration de charge doivent toujours être contrôlés par rapport aux instructions du fabricant du stérilisateur... efroidissement – Une fois retiré du stérilisateur, ce dispositif doit être correctement refroidi... près stérilisation à l’autoclave, laisser sécher complètement le dispositif avant de l’utiliser... ONDITIONS DE STOCKAGE Les produits doivent être conservés dans leur emballage d’origine non ouvert et à l’abri de l’humidité... G... NFORMATIONS Il est conseillé au chirurgien de passer en revue la technique chirurgicale spécifique au produit avant de pratiquer une intervention... rthrex propose des techniques chirurgicales détaillées sous forme de documents imprimés, de documents électroniques et sous format vidéo... e site Web d’Arthrex propose également des informations détaillées sur la technique chirurgicale et des démonstrations... n peut également contacter son représentant Arthrex pour une démonstration sur site... ITALIANO DFU-0144r3 A... ESCRIZIONE Con i telecomandi sterilizzabili in autoclave è possibile controllare le pompe per artroscopia della serie AR-6400... l telecomando AR-6476 non può essere utilizzato con la pompa per artroscopia a doppia onda AR-6480... on questo modello di pompa è invece possibile usare il telecomando a doppia onda AR-6482... l telecomando consente di regolare le impostazioni da una distanza massima di 3 metri dall’unità di comando della pompa... ota: Le funzioni di Avviamento/Arresto e Sciacquo non sono utilizzabili nella Pompa a onda continua originale e nella Pompa a onda continua II... VVERTENZE... on scollegare il telecomando tirando il cavo... strarre la spina del telecomando afferrando il corpo del connettore... ON usare MAI liquidi per pulire i contatti del connettore del telecomando... liminare frequentemente la polvere con aria compressa secca... ULIZIA E DISINFEZIONE Il telecomando può essere pulito e disinfettato utilizzando i normali disinfettanti di superficie disponibili in commercio... eguire sempre le istruzioni dei produttori dei detergenti e dei disinfettanti... MBALLAGGIO ED ETICHETTATURA 1... dispositivi Arthrex devono essere accettati alla consegna solo se l’imballaggio e l’etichettatura del fabbricante sono intatti... ontattare il Servizio clienti se la confezione è stata aperta o alterata... TERILIZZAZIONE Questo dispositivo viene fornito non sterile e può essere sterilizzato... concepito per resistere ad almeno 300 cicli di sterilizzazione a vapore in autoclave... eve essere pulito bene, quindi sterilizzato mediante uno dei seguenti parametri di sterilizzazione... uesta unità NON può essere immersa in liquidi o sterilizzata chimicamente... eguire le linee guida, le norme e la legislazione del proprio Paese... ARAMETRI DI STERILIZZAZIONE: ESCLUSIVAMENTE PER GLI STATI UNITI: Temperatura di Te m p o d i Tempo di esposizione esposizione essiccazione Ciclo di steriliz- 121°C (250°F) 30 minuti da 15 a 30 minuti zazione a vapore 132°C (270°F) 15 minuti da 15 a 30 minuti ad eliminazione dell’aria per gra135°C (275°F) 10 minuti 30 minuti vità: Ciclo prevuoto 132°C (270°F) 4 minuti da 20 a 30 minuti 135°C (275°F) 3 minuti 16 minuti PARAMETRI DI STERILIZZAZIONE: ESCLUSIVAMENTE PER GLI ALTRI PAESI (NON USA): Temperatura di Te m p o d i Tempo di esposizione esposizione essiccazione Ciclo di steriliz- 132°C – 135°C zazione a vapore (270°F – 275°F) 18 minuti da 15 a 30 minuti ad eliminazione dell’aria per gra- 121°C (250°F) 30 minuti da 15 a 30 minuti vità: Ciclo prevuoto 132°C - 135°C (270°F - 275°F) 4 minuti da 20 a 30 minuti Determinati strumenti Arthrex utilizzabili per questa procedura vengono forniti non sterili e devono essere puliti e sterilizzati accuratamente prima di ogni uso... er informazioni specifiche, consultare DFU-0023 e ANSI/AAMI ST79, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities” (“Guida completa alla sterilizzazione a vapore e garanzia di sterilità in centri medici”)... li sterilizzatori vengono prodotti in modelli e con caratteristiche di rendimento diversi... ccorre sempre verificare i parametri dei cicli e la configurazione del carico riferendosi alle istruzioni del produttore della sterilizzatrice... affreddamento - Questo dispositivo deve essere raffreddato adeguatamente dopo la rimozione dallo sterilizzatore... opo la sterilizzazione in autoclave, assicurarsi che il dispositivo sia completamente asciutto prima di utilizzarlo... ONDIZIONI DI CONSERVAZIONE I prodotti devono essere conservati nella confezione originale chiusa e al riparo dall’umidità... G... NFORMAZIONI Si consiglia ai chirurghi di rivedere la tecnica chirurgica specifica per il prodotto prima di eseguire qualsiasi intervento... a Arthrex fornisce tecniche chirurgiche dettagliate in formato stampa, video ed elettronico... nformazioni e dimostrazioni di tecniche chirurgiche dettagliate sono inoltre disponibili nel sito web della Arthrex... ppure, contattare il rappresentante Arthrex per una dimostrazione in sede... ESPAÑOL DFU-0144r3 A... ESCRIPCIÓN Las unidades de control remoto esterilizables en autoclave funcionan con las bombas artroscópicas de la serie AR-6400... a AR-6476 no se puede utilizar con la bomba artroscópica Dual Wave, AR-6480... n su lugar, la AR-6480 utiliza el control remoto Dual Wave (AR-6482)... on la unidad de control remoto se pueden hacer ajustes a una distancia máxima de 3 metros (9,8 pies) de la unidad de control de la bomba... ota: Ciertas funciones, como encender/detener e irrigar, no se pueden utilizar con la bomba Continuous Wave original ni con la bomba Continuous Wave II... DVERTENCIAS 1... o tire del cable cuando necesite desconectar la unidad de control remoto... garre el conector entero cuando vaya a sacar el enchufe de la unidad de control remoto... o use NUNCA líquidos para limpiar los contactos del conector del control remoto... impie el polvo regularmente con aire seco comprimido... IMPIEZA Y DESINFECCIÓN La unidad de control remoto se puede limpiar y desinfectar con un desinfectante comercial normal para superficies... iga siempre las instrucciones recomendadas por el fabricante del producto de limpieza o desinfectante... MPAQUE Y ETIQUETA 1... os dispositivos Arthrex solamente deben ser aceptados si el empaque y etiquetado de fábrica están intactos... i el empaque ha sido abierto o alterado, comuníquese con el Servicio de atención al cliente... STERILIZACIÓN Este dispositivo se suministra sin esterilizar y puede esterilizarse... a unidad ha sido diseñada para durar un mínimo de 300 ciclos de esterilización a vapor en autoclave... rimero hay que lavarlo a fondo y luego esterilizarlo según uno de los siguientes parámetros de esterilización... a unidad NO puede esterilizarse por medios químicos ni sumergirse... iga las pautas, normas y requisitos particulares de su país... ARÁMETROS DE ESTERILIZACIÓN: SÓLO PARA ESTADOS UNIDOS: Temperatura de Tiempo de Tiempo de secado exposición exposición Ciclo de este- 121 °C (250 °F) 30 minutos 15 a 30 minutos rilización al 132°C (270°F) 15 minutos 15 a 30 minutos vapor con desplazamiento 135°C (275°F) 10 minutos 30 minutos por gravedad Ciclo prevacío 132°C (270°F) 4 minutos 20 a 30 minutos 135°C (275°F) 3 minutos 16 minutos PARÁMETROS DE ESTERILIZACIÓN: FUERA DE ESTADOS UNIDOS: Temperatura de Tiempo de Tiempo de secado exposición exposición Ciclo de este- 132 °C – 135 °C rilización al (270 °F – 275 °F) 18 minutos 15 a 30 minutos vapor con desplazamiento 121°C (250°F) 30 minutos 15 a 30 minutos por gravedad 132 °C – 135 °C Ciclo prevacío 4 minutos 20 a 30 minutos (270 °F – 275 °F) Algunos instrumentos de Arthrex que pueden utilizarse durante este procedimiento se suministran sin esterilizar, y deben limpiarse y esterilizarse adecuadamente antes de usarlos o de volver a usarlos... onsulte las instrucciones de DFU-0023 y la norma ANSI/AAMI ST79, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities” (Guía completa de esterilización a vapor y garantías de esterilidad en centros médicos) para obtener información específica... as características de diseño y rendimiento varían de un esterilizador a otro... or eso es necesario verificar siempre los parámetros del ciclo y la configuración de carga comparándolos con las instrucciones del fabricante del esterilizador... nfriamiento: después de sacar el dispositivo del esterilizador, es necesario dejarlo enfriar de forma adecuada... a unidad debe estar totalmente seca después de la esterilización en autoclave para poder usarla... ONDICIONES DE ALMACENAMIENTO Los productos deben almacenarse en el empaque original sin abrir en un lugar libre de humedad... G... NFORMACIÓN Se recomienda que el cirujano repase la técnica quirúrgica específica del producto antes de la operación... rthrex facilita estas técnicas en detalle en formato impreso, de video y electrónico... n el sitio web de Arthrex se puede encontrar información sobre técnicas quirúrgicas y demostraciones... ambién se puede solicitar que el representante de Arthrex haga una demostración a domicilio...

Remote Control Directions for Use Rev 3