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Contact Information

DualWave Arthroscopy Pump

User’s Guide

LM1-0630-EN_E

Page 43 of 43

Contact Information

15.0

Arthrex, Inc.

Naples, FL 34108-1945 USA

Tel: +1 239-643-5553

Fax: +1 239-643-6218

Toll-Free Technical Support: +1 888 420-9393,
Monday through Friday, 9:00 AM – 5:00 PM ET.

www.arthrex.com

Arthrex Med. Inst. GmbH

Carl-Zeiss-Strasse 8

D-85748 Garching/München, Germany

Tel: 49 81 31 59 57 0

Fax: 49 81 31 59 57 565

www.arthrex.de

15.1

Compliance Information

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.

According to MDD93/42/EEC, Annex IX, Rule 11, this device is classified as a
Class IIa device.

Содержание AR-6480

Страница 1: ...ncluding accessories All operating personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and precautions U S PATENT No 5 520 638 0086 Arthrex Inc Naples FL 34108 1945 USA Toll Free 800 934 4404 www arthrex com Arthrex Med Inst GmbH 85757 Karlsfeld Germany Telephone 49 81 31 59 57 290 www arthrex de LM1 0630 EN_E 2012 Arthrex Inc All rig...

Страница 2: ......

Страница 3: ...tions 12 2 5 1 Tubing Main Pump Tubing Set AR 6410 14 2 5 2 Tubing Extension Tubing System AR 6220 15 2 5 3 Tubing ReDeuce Pump Tubing AR 6411 15 2 5 4 Tubing ReDeuce Patient Tubing AR 6421 15 2 5 5 Tubing Y Adapter Tubing AR 6215 15 2 5 6 Tubing Outflow Tubing AR 6430 15 2 5 7 Tubing Outflow with ReDeuce Patient Tubing AR 6435 15 2 5 8 Technical Specifications 16 3 0 Console 16 3 1 1 Foot Pedal 1...

Страница 4: ... Initial Pressure Settings 26 5 2 How to Operate the AR 6480 in INFLOW ONLY Mode 27 5 3 How to Operate the AR 6480 in INFLOW OUTFLOW Mode 28 5 4 How to Operate the AR 6480 in LAVAGE Mode 28 5 5 How to Operate the AR 6480 in RINSE Mode 28 5 6 Alternative Suction Pathway ASP Mode 29 Cleaning and Disinfecting 30 6 0 6 1 Console AR 6480 30 6 2 Remote Control Unit AR 6482 30 6 3 Footswitches Control Un...

Страница 5: ...Table of contents LM1 0630 EN_E Page iii of 43 Limited Warranty 38 12 0 Repair Policy 39 13 0 Electromagnetic Emissions 40 14 0 Contact Information 43 15 0 15 1 Compliance Information 43 ...

Страница 6: ... 6482 11 Table 6 Elements of the Main Pump Tubing Configuration 12 Table 7 Elements of the ReDeuce Tubing Configuration 13 Table 8 Elements of the Outflow Tubing Configuration 14 Table 9 Control Unit AR 6480 Specifications 16 Table 10 Ambient conditions for operation 16 Table 11 Ambient conditions for storage in shipping packaging 16 Table 12 Foot Pedal Unit AR 6483 Specifications 16 Table 13 Remo...

Страница 7: ...lways 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 followed W A R N I N G FAILURE TO FOLLOW SET UP INSTRUCTIONS AND OR CONTINUING TO USE THE PUMP WITHOUT RESOLVING AN ALARM CONDITION COULD RESULT IN A SERIOUS PATIENT ADVERSE EVENT Failure to adhere to the set ...

Страница 8: ...tion using these symbols and conventions W A R N I N G The WARNING is the most important safety symbol It identifies critical information that must be followed precisely to avoid injury or death Safety Sign Follow Operating Instructions Power Standby On Attention Consult Accompanying Document The CAUTION symbol identifies methods and procedures that must be followed to avoid damaging the device or...

Страница 9: ... Federal Law Restricts this device to sale by or on the order of a Physician Fragile Keep Dry This Side Up Temperature Limits for Storage and Transport x Square brackets that enclose a letter number or lower case Roman numeral reference a callout on a line drawing Section 2 2 Product Features includes line drawings of all products associated with the AR 6480 Each line drawing has its own callout s...

Страница 10: ...ceiving the device Refer also to our General Terms of Business A 12 month warranty is provided to the first purchaser for any defects or failure of the medical devices All defective products will be repaired or replaced at the discretion of Arthrex at no charge The warranty does not cover damage caused by unlawful use or improper handling of a product Warranty is not valid if modifications are mad...

Страница 11: ...o clear joint spaces quickly The user defined settings for inflow pressure and outflow rates are adjustable through controls located on the touch panel screen or on the remote control There are four pump tubing options for the AR 6480 1 Main Pump Tubing Set only This tubing when used alone must be replaced after each patient 2 Main Pump Tubing Set and Extension Tubing combination The Main Pump Tub...

Страница 12: ...onsole Table 1 Front Panel Elements 1 Inflow tubing track 2 Tubing sensor 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 and foot pedal connector 5 Touch panel visual display TPVD 6 Outflow suction tubing pinch roller 7 Outflow...

Страница 13: ...onsole s rear panel which are listed and labeled in Table 2 These callouts are referenced throughout this User s Guide Figure 2 Rear Panel of Console Table 2 Rear Panel Elements 14 Input line and fuses 15 Equipotential ground connector and symbol 16 Shaver Detect power socket 17 Shaver or Output Fuse 18 Access panel For Arthrex authorized use only 19 Date of manufacture and serial number label ...

Страница 14: ...P 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 Fail Message appears if the ha...

Страница 15: ...and length 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...

Страница 16: ...nect the plug of the foot pedal unit by pulling on the cable Remove the foot pedal unit plug by grasping and pulling on the body of the connector 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 Increases the outflow rate and pressure by a rate and time selected by the user The Pump can also ...

Страница 17: ...rcase 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 five...

Страница 18: ... Main Pump Tubing Configuration Table 6 Elements of the Main Pump Tubing Configuration Element Description Tubing Set a Bag spikes Y Adapter Tubing b Tubing clamps Y Adapter Tubing Main Pump Tubing Extension Tubing c Green connector Main Pump Tubing d Tubing boot Main Pump Tubing e Pressure line connector Main Pump Tubing f Neoprene tube for sensing pressure fluctuations Main Pump Tubing g Sensor ...

Страница 19: ...on Tubing Set a Bag spikes Y Adapter Tubing b Tubing clamps Y Adapter Tubing ReDeuce Pump Tubing ReDeuce Patient Tubing c Green connector ReDeuce Pump Tubing d Tubing boot ReDeuce Pump Tubing e Pressure line connector ReDeuce Pump Tubing f Neoprene tube for sensing pressure fluctuations ReDeuce Pump Tubing g Sensor chamber ReDeuce Pump Tubing k High flow dual lumen connectors ReDeuce Pump Tubing R...

Страница 20: ... egress Outflow E Outflow Fixture Outflow F Tubing loop for Outflow roller Outflow G Paper retaining strap Outflow Tubing Main Pump Tubing Set AR 6410 2 5 2 The Main Pump Tubing Set offers inflow and pressure measurement tubing If used alone the tubing must be completely discarded following each surgical procedure The Main Pump Tubing is 13 feet 4 0 meters in length NOTE This User s Guide assumes ...

Страница 21: ...d permits its use for the entire surgical day The ReDeuce Pump Tubing must be used with the ReDeuce Patient Tubing Tubing ReDeuce Patient Tubing AR 6421 2 5 5 The ReDeuce Patient Tubing must be used in the first arthroscopic procedure of the surgical day and replaced after each surgical procedure It is used in conjunction with the ReDeuce Pump Tubing The backflow check valve of the ReDeuce Patient...

Страница 22: ...pply 100 240 V 50 60 Hz 4A Fuse T8 0A 250V Cleaning Surface cleaning with mild detergent Sterilization Surface disinfection with mild disinfectant Table 10 Ambient conditions for operation Temperature 50 to 104 F 10 to 40 C Relative Humidity 30 to 75 non condensing Air pressure 10 15 PSI 700 hPa to 15 37 PSI 1060 hPa Table 11 Ambient conditions for storage in shipping packaging Temperature 22 to 1...

Страница 23: ...age 17 of 43 Remote Control 3 1 3 Table 13 Remote Control Unit AR 6482 Specifications Width 2 5 inches 63 5 mm Height 3 8 inches 95 3 mm Depth 0 9 inches 22 2 mm Weight 0 5 lbs 0 23 kg Cable length 9 8 feet 3 m Cleaning Surface cleaning with mild detergent Sterilization Autoclave ...

Страница 24: ...st meet the electrical standards of another country NOTE Extension cords must meet local electrical standards The console is designed to meet power saving guidelines The console has an AC mains switch on the front panel 3 When the AC mains switch is OFF no electrical power is drawn by the console When the AC mains switch is ON the console executes a series of self diagnostic tests Upon successful ...

Страница 25: ...ompatibility This device may cause interference to other devices in the near vicinity if not set up and used as Arthrex instructs To determine if the AR 6480 is causing interference to other devices power OFF the AC mains power switch 3 and then ON again Try to correct the interference by following one or more of these measures 1 Reorient or relocate the receiving device 2 Increase the separation ...

Страница 26: ...y depending on if an AR 6430 Outflow Tube Set is installed on the DualWave The Shaver detection feature depends on the differential of current draw from the shaver system when it is powered on in a static state and when the shaver handpiece is activated For correct operation of Shaver Detect 1 Insure Shaver Detect power cord is properly connected between the Shaver console and the DualWave 2 Attac...

Страница 27: ... There are four Shaver Detect Presets that offer various levels of sensitivity The user may select from the four presets preloaded into the DualWave or adjust each preset according to individual need This can be done by pressing the EDIT button after a preset has been selected There are three settings inside each preset that are changeable by the user 1 THRESHOLD is the level of sensitivity that t...

Страница 28: ... shaver detect circuit This action can result in a false detection Increasing the DELAY value should alleviate this condition As the DELAY value increases the accuracy of the determination of the shaver handpiece state will improve but at the highest levels the DELAY time may result in a perceived lag before the DualWave responds to the shaver activation The shaver detect function of the DualWave ...

Страница 29: ...ReDeuce Patient Tubing W A R N I N G The Extension or Patient Tubing must be changed for each patient 1 The surgical staff removes the sterile Extension or Patient Tubing from its sterile pack and hands the connector h or k for the Pump Tubing set 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 Attach the sterile ...

Страница 30: ...erating limits In the event of a fault the pump motor is automatically disabled and an error message is displayed on the TPVD 5 See Table 3 for a complete list of TPVD messages and Section 11 0 for troubleshooting information NOTE If abnormal console operation cannot be corrected disinfect the pump re package in the original shipping materials and return to Arthrex accompanied by a brief descripti...

Страница 31: ... 12 4 The pump motor automatically deactivates when the tubing is disconnected from the pump If the tubing is disconnected during a surgical procedure it must be replaced by new tubing Do not reconnect the tubing to the pump as it could lead to unreliable pressure measurements W A R N I N G If the tubing is disconnected from the pump in the middle of a procedure it must be replaced Do not attempt ...

Страница 32: ...ion Always start with the lowest possible 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 b...

Страница 33: ...ir bubbles NOTE It is not necessary to remove the air within 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 clamp is firmly closed If the rollers turn continuous...

Страница 34: ...he AR 6480 pump has a LAVAGE function for haemostatic purposes The LAVAGE mode is accessible in INFLOW ONLY and INFLOW OUTFLOW MODE W A R N I N G User programmed Pressure Set values are increased by as much as 50 to a maximum of 120 mmHg during the LAVAGE function Exercise caution to avoid injury to the patient 1 Press the LAVAGE button Table 3 or I to enable this function The LAVAGE button should...

Страница 35: ... In ASP Mode changes the suction pathway from the shaver suction pathway to the cannula suction pathway at the shaver suction level 1 Turn ON ASP MODE in OUTFLOW SHAVER default menu 2 Press the RINSE button on the Remote control or Foot Pedal iv while the shaver is activated to enable this function The Shaver button will turn Red The suction pathway will change from the shaver suction pathway to t...

Страница 36: ...can be cleaned disinfected using commercially available surfactants or surface disinfectants Always comply with the instructions issued by the manufacturer of the surfactant or disinfectant It is not designed to be submersed in Gluteraldehyde Steris or Sterrad disinfectants NEVER use liquid to clean the connector contacts of the remote control unit connector Remove dust regularly with dry compress...

Страница 37: ...h new surgical procedure The tubing is supplied pre packaged sterile by EO sterilization Do not re sterilize Every Extension or Patient Tubing Set is supplied with a sterile connector cap for the Pump Tubing Set connection Use this connector cap to cover the Pump Tubing Set connector after each surgical procedure to maintain sterility and assure safe use throughout the entire surgical day ...

Страница 38: ...y in design and performance characteristics so cycle parameters should always be verified against the sterilizer manufacturer s instructions for the specific sterilizer and load configuration being used It is recommended that the user perform appropriate validation tests Drying It is recommended to use a dry cycle of a minimum of 4 minutes Cooling Once removed from the sterilizer the device must b...

Страница 39: ...ase are believed to be resistant to normal processes of disinfection and sterilization Therefore the normal processing methods of decontamination and sterilization as described above may not be appropriate where CJD transmission is a risk In general the tissues that come into contact with orthopedic surgical instruments are those of low TSE infectivity However take particular precautions when hand...

Страница 40: ...E Page 34 of 43 Maintenance 9 0 There is no recommended maintenance schedule Follow instructions listed in Section 6 0 for cleaning the console and remote control units If the AR 6480 should malfunction contact an Arthrex representative or Arthrex Technical Support ...

Страница 41: ...upport may request the software version of the pump 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 TPVD during the power up sequence 10 2 Additional Technical Information Contact your Arthrex representative if require more comprehensive technical information or consult the DualWave Service G...

Страница 42: ...ge mode 2 Increase pressure 3 Decrease outflow 4 If failure remains return to Arthrex for repair Does not pump when activated 1 Check for error messages 2 Open all tubing clamps and shut off valves 3 Ensure actual pressure is below target pressure 4 Check if the tubing is pinched kinked or blocked 5 If failure remains return to Arthrex for repair Door Open 1 Roller Housing not secured ensure locki...

Страница 43: ...aver cable is connected 2 Turn On and Off DualWave while the shaver system is powered on 3 Adjust the DELAY and or THRESHOLD settings 4 Isolate the power source 5 If failure remains return to Arthrex for repair Troubleshooting Interference with Other Devices 11 1 Try one or more of the following to correct interference Reorient or relocate the receiving device Increase the distance between devices...

Страница 44: ... If Arthrex determines that any product or service is not defective or that Arthrex is not liable for the defect the Customer will be notified thereafter Arthrex will repair or replace such product upon the Customer s written consent and at prevailing prices Arthrex may in its discretion provide reasonable use of loaner Equipment while repair or replacement is underway This warranty applies only t...

Страница 45: ...Repair Policy DualWave Arthroscopy Pump User s Guide LM1 0630 EN_E Page 39 of 43 Repair Policy 13 0 Contact Arthrex for a Return Authorization Number and instructions prior to returning the device ...

Страница 46: ...tly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Table 17 Guidance and Manufacturer s Statement Electromagnetic Immunity The AR 6480 DualWave Arthroscopy Pump is intended for use in the electromagnetic environment specified below The ...

Страница 47: ... 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 95 Reduction 10ms 60 Reduction 100ms 30 Reduction 500ms 95 Reduction 5s Mains power quality should be that of a typical commercial or hospital environment If the AR 6480 DualWave Arthroscopy Pump requires continued operation during power mains interruptions it is recommended that the AR 6480 DualWave Arthroscopy Pump be powered...

Страница 48: ...to 80 MHz 3 Vrms 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the AR 8305 Synergy Resection System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17P1 2 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz ...

Страница 49: ...www arthrex com Arthrex Med Inst GmbH Carl Zeiss Strasse 8 D 85748 Garching München Germany Tel 49 81 31 59 57 0 Fax 49 81 31 59 57 565 www arthrex de 15 1 Compliance Information 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 According to MDD9...

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