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

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Table of contents 1.0 General Warnings and Safety Notices - Read This First ... 1 1.1

Important Safety Conventions ... 1

1.2

Symbols Definition ... 4

1.3

Shipping, Unpacking, and Warranty Information ... 6

2.0 Product Description ... 7 2.1

Product Description and Intended Use... 7

2.2

Product Features... 9

2.2.1

AR-6480 Console: Front View ... 9

2.2.2

AR-6480 Console: Rear View ...10

2.2.3

AR-6480 Operator Display Messages and Iconography ...11

2.3

Foot Pedal Unit (AR-6483) ... 13

2.4

Remote Control Unit (AR-6482) ... 14

2.5

Tubing ... 15

2.5.1

Tubing Configurations ...15

2.5.2

Main Pump Tubing Set (AR-6410: Region A) ...17

2.5.3

ReDeuce™ Pump Tubing Set (AR-6411: Region A) ...18

2.5.4

ReDeuce Patient Tubing Set (AR-6421: Region A) ...18

2.5.5

Extension Tubing System (AR-6220: Region A)...18

2.5.6

One-Piece Tubing Set System (AR-6415/AR-6415CL: Region B) ...18

2.5.7

Main Pump Tubing Set (AR-6420/AR-6420CL: Region B) ...18

2.5.8

Patient Extension Tubing System (AR-6425: Region B) ...19

2.5.9

Outflow Pump Tubing Set (AR-6430) ...19

2.5.10

Outflow Tub set with ReDeuce Tubing System (AR-6435: Region A) ...19

2.5.11

Y-Adapter Tubing (AR-6215) ...19

3.0 Technical Specifications ... 21 3.1

Console ... 21

3.2

Foot Pedal ... 22

3.3

Remote Control ... 22

3.4

Safety, EMC, and Regulatory Requirements... 22

4.0 Setup ... 23 4.1

How to Set Up the Console ... 23

4.2

AC Power Safety Considerations ... 23

4.3

Replacing the Fuses ... 24

DFU-0212 Rev. 1

Page i

Table of contents 4.4

Electromagnetic Compatibility (EMC) ... 25

4.5

Basic Setup Procedure for the AR-6480 ... 25

4.6

Shaver Detect ... 27

4.6.1

Shaver Detect, Synergy System Connection ...27

4.6.2

Shaver Detect, Shaver Power Cable ...27

4.6.3

Shaver Detect, Inflow only ...28

4.6.4

Shaver Detect, Inflow/Outflow ...28

4.6.5

Adjusting the Shaver Detect...29

4.7

How to Set Up the Synergy Heads-Up Display ... 30

4.8

How to Set Up Pump Tubing ... 30

4.9

How to Set Up the Two-Piece Tubing System ... 31

4.10

How to Set Up the Outflow Tubing ... 31

4.11

How to Change the Language Setting ... 32

4.12

How to Test the Power Supply Voltages ... 32

4.13

Safe Setup and Performance ... 32

4.13.1

Abnormal Operation ...32

4.13.2

Overpressure Sensing ...32

4.13.3

Roller Housing ...32

4.13.4

Tubing Sensor Coupler ...33

4.14

Shutdown Procedure ... 33

5.0 Operation and Frequently Used Functions ... 34 5.1

Initial Pressure Settings ... 34

5.2

How to Operate the AR-6480 in INFLOW ONLY Mode... 35

5.3

How to Operate the AR-6480 in INFLOW/OUTFLOW Mode ... 36

5.4

How to Operate the AR-6480 in LAVAGE Mode ... 36

5.5

How to Operate the AR-6480 in RINSE Mode ... 37

5.6

Alternative Suction Pathway (ASP) Mode ... 37

6.0 Cleaning and Disinfecting ... 38 6.1

Console (AR-6480) ... 38

6.2

Remote Control Unit (AR-6482) ... 38

6.3

Foot Pedal Control Unit (AR-6483) ... 39

6.4

Tubing ... 40

7.0 Sterilization ... 41 DFU-0212 Rev. 1

Page ii

Table of contents 7.1

Transmissible Spongiform Encephalopathy Agents ... 41

8.0 Maintenance ... 42 8.1

Periodic Maintenance... 42

9.0 Technical Support... 43 9.1

How to Display the Software Version ... 43

9.2

Additional Technical Information ... 43

10.0

Troubleshooting ... 44

10.1

Troubleshooting Interference with Other Devices ... 45

11.0

Repair Policy ... Error! Bookmark not defined.

12.0

End of Life, Environmental Directives ... 47

13.0

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

Figure 6

Two-Piece Tubing Configuration ... 16

Figure 7

Outflow Tubing Configuration (AR-6430) ... 17

DFU-0212 Rev. 1

Page iii

Table of contents List of Tables Table 1

Front Panel Elements ... 9

Table 2

Rear Panel Elements ... 10

Table 3

AR-6480 Operator Display Messages and Iconography... 11

Table 4

Foot Pedal Elements (AR-6483) ... 13

Table 5

Remote Control Unit Elements (AR-6482) ... 14

Table 6

Elements of the One-Piece Tubing Configuration ... 15

Table 7

Elements of the Two-Piece Tubing Configuration ... 16

Table 8

Elements of the Outflow Tubing Configuration ... 17

Table 9

Tubing Set Correlation and Comparisons ... 20

Table 10

Control Unit (AR-6480) Specifications ... 21

Table 11

Ambient conditions for operation ... 21

Table 12

Ambient conditions 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 Statement - Electromagnetic Immunity... 49

Table 20

Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ... 50

This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the "Arthrex U.S. Product Warranty" section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

DFU-0212 Rev. 1

Page iv

General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide

1.0 General Warnings and Safety Notices - Read This First It is imperative that the symbols and conventions listed below be clearly understood. The DualWave Arthroscopy Pump User’s Guide identifies critical, important, and useful information using these symbols and conventions.

1.1

Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique.

W A R N I N G ! WARNING! is the most important safety symbol. It identifies critical information that must be followed precisely to avoid injury or death. 1. All fluid inflow devices, including gravity assist, may cause fluid extravasations into the surrounding tissues. This extravasation may be mild, moderate or severe. In severe cases, the resulting edema may result in a serious adverse patient event which may include compartment syndrome, nerve compromise, or death. Undiagnosed capsular defects will exacerbate fluid extravasation conditions. 2. Failure to follow the setup instructions and/or continuing to use the pump without resolving an 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 appropriate troubleshooting procedures and carefully monitor the patient. Only Arthrex certified tubing must be used 4. This device is only for use in normal arthroscopic procedures as described in the User’s Guide, under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide. 5. When utilizing any fluid management device, the patient (extremity and surrounding area) must be monitored closely by the surgical 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 followed. 6. No modification of the console (AR-6480) or accessories is allowed. DFU-0212 Rev. 1

Page 1 of 54

General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide Do not open or attempt to service this system, as this may void your warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks. If the system malfunctions, return it for servicing immediately. 7. To avoid the RISK of electric shock, this equipment must only be connected to a MAINS POWER SUPPLY with a protective earth terminal. 8. Do not have the device in direct contact with the patient if high-frequency devices are in use, or if the patient requires defibrillation. 9. To ensure that correct pressure monitoring occurs, the pump and operative site MUST be in the same horizontal plane. 10. DO NOT stack or place equipment adjacent to the AR-6480 console, if possible. If such a configuration is necessary, carefully observe the configuration in question to ensure that electromagnetic interference does not degrade performance. 11. 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 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 endogenous gases. All oxygen connections must be leak free for the duration of the surgical procedure. 14. Use only Arthrex approved tubing accessories. Other accessories may result in decreased pressure accuracy. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient and/or operating room staff injury. 15. The extension, patient, and/or outflow tubing must be replaced before each new patient and/or procedure. 16. The sterile connector cap must be used to cover the pump tubing set connector after each surgical procedure. This maintains sterility of the pump tubing and ensures its safe operation throughout the entire surgical day. 17. 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. 18. The safety and effectiveness of the AR-6480 is verified and documented; however, the AR-6480 must be used with an awareness of the risk of extra-

DFU-0212 Rev. 1

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General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide articular edemas for patients with pathologically-changed articular capsules and for procedures involving an opening of the capsule (e.g. lateral release). 19. Slight swellings have been observed and described in the literature in cases where roller pumps are used in arthroscopy. This build-up of fluid can lead to postoperative swellings and pathological changes in patients. It is of the utmost importance that the surgeon monitors both the system and the patient closely while the roller pump is in operation. 20. 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. 21. The initial pressure settings are recommendations. It is always appropriate and prudent to use the lowest possible pressure setting to minimize extravasation and any other pressure-related injury to the patient. 22. 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. 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. Only use replacement power cords that comply with medical grade standards, IEC 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. 3. Avoid positioning the console so that it is difficult to disconnect the coupler or plug from the mains power supply. 4. To prevent electrical shock do not use extension cords or two-prong/threeprong adaptors. 5. Always use fuses with the correct values to avoid allowing overcurrent to enter the system. 6. An incorrect fuse may increase the risk of electrical shock or fire hazard. 7. This device has passed testing for EMI / RFI radiation and susceptibility, and EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex. 8. Do not attach the remote control or the foot pedal during the Self Test or Programming Modes.

DFU-0212 Rev. 1

Page 3 of 54

General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide 9. NEVER use liquid to clean the accessory device connector contacts. Remove dust regularly using dry compressed air. 10. Liquid on the cable connector of the accessory device can damage the device. Before connecting the cable, ensure the receptacles are clean and dry. 11. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility. 12. Never allow the console receptacles to come into contact with liquids. If there is dust or moisture on the receptacles, remove using dry compressed air. ONLY dry connectors should be plugged into the console. 13. Do NOT clean the device with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch or damage the device. 14. Refer 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 sterilization instructions included with each tube set. Additional copies of this insert can be obtained from the Arthrex website at www.arthrex.com, or by contacting your local Arthrex representative. 16. The foot pedal is NOT suitable to be cleaned and disinfected in a thermo washer disinfector. 17. After sterilization in the autoclave, let the accessory device cool down slowly. NEVER use cold water to cool the remote control. This will damage the electronic components and seals.

1.2

Symbols Definition Safety Sign Follow operating instructions

DFU-0212 Rev. 1

Caution: Federal law restricts this device to sale by or on the order of a physician.

On/Off (push-push)

Type CF Defibrillator Proof

Caution

Fragile, handle with care

Keep dry

This side up

Page 4 of 54

General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide

DFU-0212 Rev. 1

Electrical hazard, dangerous voltages are present. Never attempt to repair the equipment. Only trained service personnel may remove the cover, or obtain access to system components.

Temperature 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. Nonionizing electromagnetic radiation

Manufacturer

Date of manufacture; year and month.

Non sterile

The product meets the essential requirements of Medical Device Directive 93/42/EWG

Catalog number

Serial number

Quantity

Authorized representative in the European Community

Page 5 of 54

General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide Remote control connection

Foot pedal connection

No user-serviceable parts inside

Do not use if package is damaged

Electrical hazard

IP22

International protection marking

USB

Universal serial bus [for use ONLY with Arthrex approved thumb drive]

[x]

1.3

RS-232

Serial port [Arthrex integration]

Square brackets that enclose a letter, number, or Roman numeral reference a callout on a line drawing. Section 2.2, Product Features, includes drawings of products associated with the AR-6480. Each line drawing has its own callout system to identify important elements of each product.

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 Terms of Business. 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. The warranty is not valid if modifications are made to the product or repairs are carried out outside of Arthrex or an authorized Arthrex distributor. Arthrex will answer any questions referring to the quality, reliability, and/or shelf life of any product identified in this User’s Guide.

DFU-0212 Rev. 1

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Product Description DualWave Arthroscopy Pump User’s Guide

2.0 Product Description 2.1

Product Description and Intended Use The Arthrex AR-6480 DualWave Arthroscopy Pump is a system that maintains constant, non-pulsed control of intra-articular rinsing and distention pressure throughout all phases of an arthroscopic surgical procedure. The AR-6480 is intended to provide continuous pulse-free flow that reacts immediately to changes in the intra-articular pressure so that joint distention can be sustained even under high shaver extraction volumes or secondary outflow.

W A R N I N G ! All fluid inflow devices, including gravity assist, may cause fluid extravasations into the surrounding tissues. This extravasation may be mild, moderate, or severe. In severe cases, the resulting edema may result in a serious adverse patient event which may include compartment syndrome, nerve compromise, or death. Undiagnosed capsular defects will exacerbate fluid extravasation conditions. When utilizing any fluid management device, the patient (extremity and surrounding area) must be monitored closely by the surgical 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 followed.

W A R N I N G ! FAILURE TO FOLLOW THE SETUP 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 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 the appropriate troubleshooting procedures and carefully monitor the patient. Only Arthrex certified tubing must be used.

W A R N I N G ! This device is only for use in normal arthroscopic procedures as described in the User’s Guide, under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide.

DFU-0212 Rev. 1

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Product Description DualWave Arthroscopy Pump User’s Guide The AR-6480 includes: • •

•

A universal medical-grade switching power supply that allows the pump to function automatically at voltage ranges found worldwide. An automatic universal Shaver Detect feature that allows the device to automatically switch from low cannula suction to high flow shaver suction on demand. There is a touch panel display for user inputs. A Lavage function to provide elevated pressure to stop bleeding and a Rinse function to 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 Applied Part pump tubing options for the AR-6480: 1.

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 AR6220 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.

Outflow tubing. 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.

The optional Y-Adapter Tubing is intended to be used with all inflow Arthrex tubing sets/system combinations to connect up to four irrigation bags. The AR-6480 can be used as an inflow-only irrigation pump or, with the outflow tubing attached; it can be used as an inflow/outflow fluid management system. Other optional accessories: • • • •

DFU-0212 Rev. 1

Remote control Foot pedal Shaver Detect cord Synergy integration cable

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Product Description DualWave Arthroscopy Pump User’s Guide

2.2

Product Features 2.2.1

AR-6480 Console: Front View

Figure 1 uses a numeric callout system to identify the main elements of the console’s front panel, which are listed and labeled in Table 1. These callouts are referenced throughout this User’s Guide. Figure 1

Front Panel of Console

Table 1

Front Panel Elements

1. 2.

3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. DFU-0212 Rev. 1

Inflow tubing track 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 AC mains power switch Remote control or foot pedal connector Operator display Outflow suction tubing pinch roller Outflow tubing sensor Outflow roller assembly Outflow door Outflow door locking mechanism Inflow door locking mechanism Inflow door Inflow roller assembly Page 9 of 54

Product Description DualWave Arthroscopy Pump User’s Guide

2.2.2

AR-6480 Console: Rear View

Figure 2 uses a numeric callout system to identify the main elements of the console’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. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

DFU-0212 Rev. 1

AC mains power input plug Shaver Detect power socket Address Void seal sticker USB port (For use ONLY with an Arthrex approved thumb drive) Serial ports for Arthrex integration (refer to IFU 950-0052-00) Access panel (for Arthrex authorized use only) Serial number label Model number label Shaver or output fuse label Shaver or output fuse Equipotential ground connector and symbol Main power input - Fuse label Main power input - Fuse holder

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Product Description DualWave Arthroscopy Pump User’s Guide

2.2.3

AR-6480 Operator Display Messages and Iconography

The console’s operator display [5] provides information about the status of the AR6480 modes, pressure, and flow settings in real time. Table 3 describes each message or button, cause and explanation when the pump is in the ready state. Table 3

AR-6480 Operator Display Messages and Iconography

Message

Cause

Explanation

Arthrex DualWave

Message appears when the AC mains power switch is activated.

Power on message display.

** Tubing Out **

Message appears when tubing is not plugged into the tubing sensor coupler [2].

Check tubing installation.

** Door Open **

Message appears when the roller housing door [9] or [12] is open.

Roller housing door is not closed.

** Over Pressure **

Message appears when the sensed pressure exceeds over-pressure software limit of 300 mmHg.

Software overpressure condition.

Critical Failure

Message appears on the first line of the operator display if one of three conditions is met: Failure Condition 1: ** Power Failure ** Appears if the power supply self-test fails when the pump is turned 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 Fail **

Message appears if the hardware overpressure diagnostic test fails when the pump is turned on.

Hardware overpressure diagnostic fails.

** Sensor Failure **

Message appears if the pump detects a problem with the pressure sensors.

Sensor failure.

** Pressure Fault **

Message appears when the pump is unable to reach a desired set pressure within a specific amount of time. This typically indicates improperly installed tubing or a split in the tube from continuous use.

Insufficient pressure.

Remote Control Icon

Icon appears when the remote is attached.

Remote connected.

Foot Pedal Icon

Icon appears when the foot pedal is attached.

Foot pedal connected.

+ Button

The operator display shows the pressure reading until the PRESSURE (+) button is pressed. Once pressed, the displayed pressure reading will change to the pressure setting. Each subsequent press of the pressure button will increase the pressure setting in increments of 5.

Pressure set increase.

DFU-0212 Rev. 1

Page 11 of 54

Product Description DualWave Arthroscopy Pump User’s Guide Message

Cause

Explanation

− Button

The operator display shows the pressure reading until the PRESSURE (-) button is pressed. Once pressed, the displayed pressure reading will change to the pressure setting. Each subsequent press of the pressure button will decrease the pressure setting in increments of 5.

Pressure set decrease.

RUN Button

Button appears when the pump is stopped. Press this button to start the pump.

Motors on.

STOP Button

Button appears when the pump is running. Press this button to stop the pump.

Motors off.

LAVAGE Button

Button appears when the pump is in either inflow only or inflow/outflow mode. Press the button and the pump will increase pressure by a user-defined amount 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 the shaver is activated.

Pressure increased.

CANNULA Button

Button appears when the pump is in inflow/outflow mode. Press the button and the user may define the outflow rate.

Outflow rate change.

SHAVER Button

Button appears when the pump is in inflow/outflow mode. Press the button and the user may define the outflow rate of the shaver and pressure increase. In ASP mode (Alternative Suction Pathway), the button is red.

Shaver suction change and pressure increase.

MENU Button

Button appears when the pump is stopped. Press the button and the pump will enter the setup menu.

User setups displayed.

DFU-0212 Rev. 1

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Product Description DualWave Arthroscopy Pump User’s Guide

2.3

Foot Pedal Unit (AR-6483) The AR-6480 DualWave Arthroscopy Pump can be remotely controlled with the optional foot pedal unit (AR-6483). It provides a Lavage function and a Rinse function. See Figure 3 and Table 4. Do not disconnect 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 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)

i Table 4 i ii

DFU-0212 Rev. 1

ii Foot Pedal Elements (AR-6483) Lavage increases the pressure by a percentage and time selected by the user. Rinse increases the outflow rate and pressure by a rate and time selected by the user. The pump can also enter Alternative Suction Pathway (ASP) if pressed while the shaver is activated and the ASP mode is enabled via the outflow shaver menu.

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Product Description DualWave Arthroscopy Pump User’s Guide

2.4

Remote Control Unit (AR-6482) The AR-6480 DualWave Arthroscopy Pump can be remotely controlled with the optional, autoclavable remote control unit (AR-6482). It provides the ability to control pressure adjustments; a Lavage function; a Rinse function; shaver suction controls; and the ability to activate and deactivate the pump motor. The remote control unit’s cable is 3 meters (9.8 ft.) in length. Do not disconnect the plug of the remote control unit by pulling on the cable. Remove the remote control unit plug by grasping and pulling on the body of the connector. Figure 4 uses an uppercase 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 II III IV

V VI VII

DFU-0212 Rev. 1

Lavage - Increases the pressure by a percentage and time selected by the user. Pressure Decrease - Decreases target pressure by five mmHg. Shaver Suction - Cycles through shaver suction settings. Rinse - Increases the outflow rate and pressure by a rate and time selected by the user. The pump can also enter Alternative Suction Pathway (ASP) if pressed while the shaver is activated and the ASP mode is enabled via the outflow shaver menu. Pressure Increase - Increases target pressure by five mmHg. Run/Stop Lemo Connector - Attaches to the corresponding plug on the front panel [4] of the AR-6480. Page 14 of 54