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DualWave™ Arthroscopy Pump

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 1.7 or higher

thoroughly prior to using this system and follow all safety warnings, cautions, and precautions.
U.S. PATENTS

No. 5,520,638 and 8,206,342

0086

Arthrex, Inc.

1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-(800) 934-4404

www.arthrex.com

Arthrex GmbH

Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0

www.arthrex.de

DFU-0212

Revision 1

DFU-0212, Rev. 1 English

Содержание DualWave

Страница 1: ...ad this User s Guide for version 1 7 or higher thoroughly prior to using this system and follow all safety warnings cautions and precautions U S PATENTS No 5 520 638 and 8 206 342 0086 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA Toll Free 1 800 934 4404 www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 www arthrex de DFU 0212 Revision 1 20...

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Страница 3: ... 6410 Region A 17 2 2 5 5 3 3 ReDeuce Pump Tubing Set AR 6411 Region A 18 2 2 5 5 4 4 ReDeuce Patient Tubing Set AR 6421 Region A 18 2 2 5 5 5 5 Extension Tubing System AR 6220 Region A 18 2 2 5 5 6 6 One Piece Tubing Set System AR 6415 AR 6415CL Region B 18 2 2 5 5 7 7 Main Pump Tubing Set AR 6420 AR 6420CL Region B 18 2 2 5 5 8 8 Patient Extension Tubing System AR 6425 Region B 19 2 2 5 5 9 9 Ou...

Страница 4: ...uage Setting 32 4 12 How to Test the Power Supply Voltages 32 4 13 Safe Setup and Performance 32 4 4 1 13 3 1 1 Abnormal Operation 32 4 4 1 13 3 2 2 Overpressure Sensing 32 4 4 1 13 3 3 3 Roller Housing 32 4 4 1 13 3 4 4 Tubing Sensor Coupler 33 4 14 Shutdown Procedure 33 5 5 0 0 Operation and Frequently Used Functions 34 5 1 Initial Pressure Settings 34 5 2 How to Operate the AR 6480 in INFLOW ON...

Страница 5: ...0 1 Troubleshooting Interference with Other Devices 45 1 11 1 0 0 Repair Policy Error Bookmark not defined 1 12 2 0 0 End of Life Environmental Directives 47 1 13 3 0 0 Electromagnetic Emissions 48 List of Figures Figure 1 Front Panel of Console 9 Figure 2 Rear Panel of Console 10 Figure 3 Foot Pedal Unit AR 6483 13 Figure 4 Remote Control Unit AR 6482 14 Figure 5 One Piece Tubing Configuration 15...

Страница 6: ...nditions for storage in shipping packaging 21 Table 13 Foot Pedal Unit AR 6483 Specifications 22 Table 14 Remote Control Unit AR 6482 Specifications 22 Table 15 Initial Pressure Settings 34 Table 16 Troubleshooting Faults their Causes and Solutions 44 Table 17 Guidance and Manufacturer s Declaration Electromagnetic Emissions 48 Table 18 System Cables 48 Table 19 Guidance and Manufacturer s Stateme...

Страница 7: ...alarm condition could result in a serious patient adverse event 3 Failure to adhere to the setup instructions and use of Arthrex certified tubing may result in inaccurate pressure sensing and monitoring by the device It is imperative that the user is aware that patient safety may be compromised when an alarm on the pump is ignored or silenced incorrectly NEVER ignore or silence alarms Follow appro...

Страница 8: ...for a complete list of accessories DO NOT modify any accessory Failure to comply may result in injury to the patient and or operating room staff 12 This equipment is NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen rich or nitrous oxide environment 13 Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide oxygen or...

Страница 9: ... to the patient 23 After autoclaving the accessory devices are VERY HOT Handle with care to avoid burns The PRECAUTION symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction 1 Do not disconnect the plug of the remote control or foot pedal unit by pulling on the cable Remove it by grasping and pulling on the body of the connector 2 O...

Страница 10: ...to the Instructions for Use package insert DFU 0144 for detailed remote control cleaning and sterilization instructions included with each remote control Additional copies of this insert can be obtained from the Arthrex website at www arthrex com or by contacting your local Arthrex representative 15 Refer to the Instructions for Use package insert DFU 0140 for detailed tubing cleaning and steriliz...

Страница 11: ...mperature limits for storage and transport Alternating current Atmospheric pressure limitation Fuse Humidity limits for storage and transport Equipotential equipment potential Protective earth terminal Electrical waste RF symbol Non ionizing electromagnetic radiation Manufacturer Date of manufacture year and month Non sterile The product meets the essential requirements of Medical Device Directive...

Страница 12: ...Shipping Unpacking and Warranty Information Carefully unpack and inspect all components for shipping damage Any damage could compromise patient safety and should be reported immediately to Arthrex or any authorized Arthrex distributor The warranty could be voided if shipping or first installation damage is not reported within seven business days of receiving the device Refer also to our General Te...

Страница 13: ...ical team for signs of excess fluid buildup Fluid usage volumes should be monitored and compared to similar surgical procedures With all arthroscopy pumps correct setup and proper user operation is required Always select the lowest possible pressures in order to achieve the required intra articular distention All alarms or alerts must be acknowledged and the appropriate troubleshooting procedure f...

Страница 14: ...One piece tubing only This tubing when used alone must be replaced after each patient 2 One piece tubing and extension tubing combination The AR 6410 can be reused for an entire surgical day while the AR 6220 must be replaced after each patient 3 Two piece tubing combination The pump tubing can be reused for an entire surgical day The patient tubing must be replaced after each surgical procedure 4...

Страница 15: ... of Console Table 1 Front Panel Elements 1 Inflow tubing track 2 Tubing sensor coupler with indicator LED A steady green LED indicates that the tubing is connected properly A flashing red LED indicates that the tubing is not connected or that it is connected incorrectly 3 AC mains power switch 4 Remote control or foot pedal connector 5 Operator display 6 Outflow suction tubing pinch roller 7 Outfl...

Страница 16: ...e 2 Rear Panel of Console Table 2 Rear Panel Elements 14 AC mains power input plug 15 Shaver Detect power socket 16 Address 17 Void seal sticker 18 USB port For use ONLY with an Arthrex approved thumb drive 19 Serial ports for Arthrex integration refer to IFU 950 0052 00 20 Access panel for Arthrex authorized use only 21 Serial number label 22 Model number label 23 Shaver or output fuse label 24 S...

Страница 17: ...ned on Failure Condition 2 OVP Detect Fail Appears if the hardware overpressure diagnostic test fails when the pump is turned on Failure Condition 3 Sensor Failure Appears if the pump detects a problem with the pressure sensors Critical failure cannot continue operation Power Failure Message appears if the power supply self test fails when the pump is turned on Power supply test fails OVP Detect F...

Страница 18: ...gth of time Pressure increased for a set time RINSE Button Button appears when the pump is in inflow outflow mode Press the button and the pump will increase outflow by a user defined amount and length of time Outflow rate and pressure increased for a set time BOOST Button Button appears when the pump is in inflow only mode Press the button and the user may define the pressure increase when the sh...

Страница 19: ... on the body of the connector Figure 3 uses a lowercase Roman numeral callout system to identify the main elements on the foot pedal unit which are listed and labeled in Table 4 These callouts are referenced throughout this User s Guide Figure 3 Foot Pedal Unit AR 6483 Table 4 Foot Pedal Elements AR 6483 i Lavage increases the pressure by a percentage and time selected by the user ii Rinse increas...

Страница 20: ...ercase Roman numeral callout system to identify the main elements on the remote control which are listed and labeled in Table 5 These callouts are referenced throughout this User s Guide Figure 4 Remote Control Unit AR 6482 Table 5 Remote Control Unit Elements AR 6482 I Lavage Increases the pressure by a percentage and time selected by the user II Pressure Decrease Decreases target pressure by fiv...

Страница 21: ...nfiguration Table 6 Elements of the One Piece Tubing Configuration Element Description Tubing Set a Bag spikes AR 6215 b Tubing clamps AR 6215 AR 6410 AR 6415 AR 6220 c Green connector AR 6410 AR 6415 d Tubing boot AR 6410 AR 6415 e Pressure line connector AR 6410 AR 6415 f Neoprene tube for sensing pressure fluctuations AR 6410 AR 6415 g Sensor chamber AR 6410 AR 6415 h Connector fittings AR 6410...

Страница 22: ...ion Tubing Set a Bag spikes AR 6215 b Tubing clamps AR 6215 AR 6411 AR 6420 AR 6421 AR 6425 c Green connector AR 6411 AR 6420 d Tubing boot AR 6411 AR 6420 e Pressure line connector AR 6411 AR 6420 f Neoprene tube for sensing pressure fluctuations AR 6411 AR 6420 g Sensor chamber AR 6411 AR 6420 k High flow dual lumen connectors AR 6411 AR 6420 AR 6421 AR 6425 i Backflow check valve AR 6421 AR 642...

Страница 23: ...low roller AR 6430 G Paper retaining strap AR 6430 2 2 5 5 2 2 Main Pump Tubing Set AR 6410 Region A The Main Pump Tubing Set offers inflow and pressure sensing tubing If used alone the tubing must be completely discarded following each surgical procedure From the pump the tubing is 4 meters 13 ft in length NOTE This User s Guide assumes that the AR 6410 is used alone or in combination with the AR...

Страница 24: ...n Tubing System AR 6220 Region A The Extension Tubing System is intended to be used in conjunction with the Main Pump Tubing Set AR 6410 to allow the Main Pump Tubing Set to be used for an entire surgical day while only replacing the Extension Tubing System after each individual surgery The extension tubing is 2 4 meters 8 ft in length 2 2 5 5 6 6 One Piece Tubing Set System AR 6415 AR 6415CL Regi...

Страница 25: ... mode to provide precisely controlled outflow from the shaver and a cannula optional to multiple waste consumption devices When the Outflow Tubing Set is attached to the AR 6480 the DualWave Arthroscopy Pump changes from an inflow only pump to an inflow outflow fluid management system 2 2 5 5 1 10 0 Outflow Tub set with ReDeuce Tubing System AR 6435 Region A A combination tube set with both outflo...

Страница 26: ...p Tubing Set as an additional extension AR 6220 Not sold in region B AR 6411 ReDeuce Tubing Set MUST be used with the AR 6421 ReDeuce Patient Tubing Set AR 6420 AR 6420CL Main Pump Tubing Set Main Pump Tubing Set with CareLock bag spikes MUST be used with the AR 6425 Patient Extension Tubing Set AR 6421 ReDeuce Patient Tubing MUST be used with the AR 6411 ReDeuce Tubing Set AR 6425 Patient Extensi...

Страница 27: ... V Connector CEE 7 7 Jack IEC 320 C13 Power supply 100 240 V 50 60 Hz 6 5A Mains fuse T8LA250V 5 x 20 mm Shaver supply fuse T5AL250VP 5 x 20 mm Applied part type CF Cleaning Surface cleaning with mild detergent Sterilization Surface disinfection with mild disinfectant Table 11 Ambient conditions for operation Temperature 10 to 40 C 50 to 104 F Relative Humidity 20 to 75 non condensing Barometric p...

Страница 28: ... 3 mm 3 8 in Depth 22 2 mm 0 9 in Weight 0 23 kg 0 5 lbs Cable length 3 m 9 8 ft Cleaning Surface cleaning with mild detergent Sterilization Autoclave 3 4 Safety EMC and Regulatory Requirements The DualWave Arthroscopy Pump AR 6480 is designed and tested in accordance with EN 60601 1 A2 1995 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 According to 60601 this device is Type CF Class 1 IP22 rating Ac...

Страница 29: ...EC 60320 1 Subclause 3 21 Detachable Power Supply Cords or electrical standards for the designated country where the AR 6480 is being used Contact your Arthrex representative for further information Avoid positioning the console so that it is difficult to disconnect the coupler or plug from the mains supply To prevent electrical shock do not use extension cords or two prong three prong adaptors NO...

Страница 30: ...ct the device from the AC mains 2 Open the fuse tray in the AC inlet by pinching the tabs and pulling outward 3 Replace the fuses with T8LA250V 5 x 20 mm Line Fuses as noted on the rear panel 4 Push the fuse holder back into the AC inlet 5 Ensure that the fuse holder is fully seated and that the tabs snap back The shaver supply fuse is replaced with T5AL250VP 5 x 20 mm as follows 1 Disconnect the ...

Страница 31: ... 3 Connect the device to an outlet on a different circuit than the other device s are connected to 4 Consult the manufacturer or field service technician for the receiving device for guidance 4 5 Basic Setup Procedure for the AR 6480 W A R N I N G To ensure that correct pressure monitoring occurs the pump and operative site MUST be in the same horizontal plane NOTE Section 5 0 Operation explains h...

Страница 32: ...e performance Do not attach the remote control or the foot pedal during the Self Test or Programming Modes W A R N I N G Use ONLY Arthrex approved accessories Other accessories may result in increased emissions or decreased immunity of the system Contact your Arthrex representative for a complete list of accessories DO NOT modify any accessory Failure to comply may result in injury to the patient ...

Страница 33: ...sion 1 8 or greater and Synergy Resection Console version 2 3 or greater Refer to IFU 950 0052 00 for more information NOTE It is recommended that the Shaver Detect Power Cable not be connected when using the Synergy System Integration cable for Shaver Detection NOTE The Shaver Detect feature will function as described in sections 4 6 3 4 6 4 4 4 6 6 2 2 Shaver Detect Shaver Power Cable The Shaver...

Страница 34: ...LAVAGE mode will be overridden except when LAVAGE mode causes a larger pressure increase 4 4 6 6 4 4 Shaver Detect Inflow Outflow During inflow outflow operation outflow tube set present the DualWave responds to shaver activation by closing the cannula suction tube and opening the shaver suction tube for fluid egress The level of suction will automatically change to either the preset shaver suctio...

Страница 35: ...ole before it activates the pinch roller mechanism This ranges from 0 10 1 10th of a second 3 DRIFT TRACKER controls whether or not the DualWave will constantly adjust the stored shaver current baseline reading This can be turned on or off Once the necessary adjustments have been made press the DONE button to save the changes to the selected preset Note to the user Select the highest THRESHOLD tha...

Страница 36: ...otential hazards of utilizing the DualWave with an alternate shaver console 4 7 How to Set Up the Synergy Heads Up Display 1 First obtain the Synergy System Integration Cable Kit AR 3200 1040 2 Connect the Synergy System Integration Cable between the rear panel of the DualWave 19 and the rear of the Synergy Imaging Console communication connections labeled RS 232 3 Turn on the DualWave and Synergy...

Страница 37: ...et to the circulating nurse 2 The circulating nurse connects the two tubing systems together h to h in Figure 5 or k to k in Figure 6 3 At the end of each case detach the extension or patient tubing set and attach the sterile connector cap supplied with each extension or patient tubing set to the patient end of the pump tubing NOTE Following each surgery detach and discard the extension or patient...

Страница 38: ...st of operator display messages and section 10 0 for troubleshooting information NOTE If abnormal console operation cannot be corrected disinfect the pump repackage in the original shipping materials and return to Arthrex accompanied by a brief description of the malfunction Prior to shipping it is necessary to obtain a return authorization number from Arthrex 4 4 1 13 3 2 2 Overpressure Sensing T...

Страница 39: ...edure it must be replaced by new tubing Do not reconnect the tubing to the pump as it could lead to unreliable pressure W A R N I N G If the tubing is disconnected from the pump it must be replaced Do not attempt to reconnect the tubing to the pump as it could lead to unreliable pressure 4 14 Shutdown Procedure The AR 6480 can be safely shut down at any time by powering down the console All tubing...

Страница 40: ...pressure to achieve the desired joint distention Continue to increase distention pressure until a clear liquid medium is obtained After the DualWave power up sequence has finalized the user will be able to select from four preprogrammed pressure settings for the knee shoulder small joint and hip joint spaces Once the icon for the selected joint space has been pressed the DualWave will display the ...

Страница 41: ...ithin the sensor chamber g on the pump tubing set 5 After the air has been purged from the tubing close the clamp at the patient end of the tubing The rollers 13 should stop turning This is a safety check to ensure that the sensor system is working properly If the rollers do not stop ensure the clamp is firmly closed If the rollers turn continuously the pressure line connector e may not be functio...

Страница 42: ...lue tubing labeled CANNULA can be attached to an outflow cannula working cannula or left unutilized NOTE If the CANNULA tubing end is not used leave unclamped or set cannula suction to off 5 4 How to Operate the AR 6480 in LAVAGE Mode The AR 6480 pump has a LAVAGE function for hemostatic purposes The LAVAGE mode is accessible in INFLOW ONLY and INFLOW OUTFLOW MODE W A R N I N G User programmed Pre...

Страница 43: ... 5 6 Alternative Suction Pathway ASP Mode The AR 6480 pump has an ASP function for minimizing clogging issues The ASP MODE is only accessible in INFLOW OUTFLOW MODE ASP mode changes the suction pathway from the shaver suction pathway to the cannula suction pathway while shaving The shaver suction level will be maintained while the shaver is activated 1 Turn ON ASP MODE in the OUTFLOW SHAVER defaul...

Страница 44: ...concentration exposure times temperature and material compatibility NEVER allow the console receptacles to have any contact with liquids If there is dust or moisture on the receptacles remove with dry compressed air ONLY dry connectors should be plugged into the console Do NOT clean the device with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch or damage...

Страница 45: ...isinfectant for surfaces Alkaline agents with a pH value 8 are to be avoided Clean the foot pedal with an enzymatic cleaner without subsequent acid neutralization Rinse the foot pedal thoroughly under lukewarm water after cleaning Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration exposure times temperature and material compatibility...

Страница 46: ...ditional copies of this insert can be obtained from the Arthrex website at www arthrex com or by contacting your local Arthrex representative W A R N I N G The extension patient and or outflow tubing must be replaced before each new patient and or procedure Every extension or patient tubing set is supplied with a sterile connector cap for the pump tubing set connection Use this connector cap to co...

Страница 47: ...e cable connector of the accessory device can damage the device Before connecting the cable ensure the receptacles are clean and dry W A R N I N G After autoclaving the accessory devices are VERY HOT Handle with care to avoid burns 7 1 Transmissible Spongiform Encephalopathy Agents It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible...

Страница 48: ... is extremely knowledgeable about the Arthrex Medical DualWave Arthroscopy Pump tubing and or foot pedal and remote control and will provide a competent and efficient service Any services and or repairs carried out by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure 8 1 Periodic Maintenance The product should be inspected prior to and afte...

Страница 49: ...hrex de from 8 00 AM to 5 00 PM CET 9 1 How to Display the Software Version Technical Support may request the pump s software version Follow these instructions to display the software version 1 Power on the AC mains power switch 3 on the AR 6480 2 The software version is displayed on the operator display during the power up sequence 9 2 Additional Technical Information Contact your Arthrex represe...

Страница 50: ...t the tubing pressure line connector e is seated completely 4 Change the tubing 5 If the failure persists return to Arthrex for repair Console fails Self Diagnostic Test 1 Ensure no tubing is connected to the pump during the power on sequence 2 If the failure persists return to Arthrex for repair Console will not power up 1 Check the AC mains power cord 2 Try an alternate power outlet 3 Check the ...

Страница 51: ... THRESHOLD settings 4 Isolate the power source 5 If the failure persists return to Arthrex for repair If the problems persist disinfect the DualWave Arthroscopy Pump and send to Arthrex using the original packaging Always send the corresponding console together with the tubing foot pedal and remote control Please enclose a brief explanation of the detected malfunction Refer to section 11 0 for mor...

Страница 52: ...epair Policy DualWave Arthroscopy Pump User s Guide DFU 0212 Rev 1 Page 46 of 54 1 11 1 0 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device ...

Страница 53: ... The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste Instead it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment The separate collection and recycling of your waste equipment at the time of disposal will help co...

Страница 54: ...nction Therefore its RF emissions are very low and not likely to cause any interference with nearby electronic equipment RF emissions CISPR 11 Class A The AR 6480 DualWave Arthroscopy Pump is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC...

Страница 55: ...ital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Uτ 95 dip in Uτ for 0 5 cycle 40 Uτ 60 dip in Uτ for 5 cycles 70 Uτ 30 dip in Uτ for 25 cycle...

Страница 56: ...ccording to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range a...

Страница 57: ... Arthroscopy Pump User s Guide DFU 0212 Rev 1 Page 51 of 54 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ...

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Страница 60: ...945 USA www arthrex com Customer Service 1 800 934 4404 Toll Free Technical Support 1 888 420 9393 Monday through Friday 9 00 AM 5 00 PM EST Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 www arthrex de All rights reserved 0086 Comp dfu 0212 1 r0 ...

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