DFU-0218, Rev.

1 English

Continuous Wave III

Arthroscopy Pump
User’s Guide
The Arthrex Continuous Wave III Arthroscopy Pump User’s Guide
provides important safety operation information for all components
of the Arthrex Continuous Wave III Arthroscopy Pump (Model AR-
6475), and accessories. All Operating Personnel should read this
AR-6475
User’s Guide thoroughly before using this system and follow all
safety warnings, cautions, and precautions.

U.S. PATENT No. 5,520,638

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-0218
Revision 1

© 2013 Arthrex, Inc. All rights reserved.

 Table of contents

1.0 General Warnings and Safety Notices - Read This First ..................... 1
1.1 Important Safety and Conventions Information .................................................. 1
1.2 Symbols Definition ............................................................................................. 5
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-6475 Console: Front View ................................................................................. 9
2 . 2 .2 AR-6475 Console: Rear View ............................................................................... 10
2 .2 .3 AR-6475 Vacuum Fluorescent Display Messages ................................................ 11
2 .2 .1 Measured Pressure Bar Graph ............................................................................. 12
2.3 Remote Control Unit (AR-6476) ....................................................................... 13
2.4 Tubing .............................................................................................................. 14
2 .4 . 1 Tubing Configurations ........................................................................................... 14
2 .4 .2 Main Pump Tubing Set (AR-6410: Region A) ....................................................... 16
2.4.3 Extension Tubing System (AR-6220: Region A) ................................................... 16
2.4.4 ReDeuce™ Pump Tubing Set (AR-6411: Region A) ............................................. 16
2.4.5 ReDeuce Patient Tubing (AR-6421: Region A) ..................................................... 16
2.4.6 One Piece Tubing Set System (AR-6415/AR-6415CL: Region B) ........................ 16
2.4.7 Main Pump Tubing Set (AR-6420/AR-6420CL: Region B) .................................... 17
2.4.8 Patient Extension Tubing System (AR-6425: Region B) ....................................... 17
2.4.9 Y-Adapter Tubing (AR-6215) ................................................................................. 17
3.0 Technical Specifications .................................................................... 19
3.1 Console ............................................................................................................ 19
3.2 Remote Control ................................................................................................ 19
4.0 Setup ................................................................................................. 20
4.1 How to Set Up the Console .............................................................................. 20
4.2 AC Power Safety Considerations ..................................................................... 20
4.3 Replacing the Fuses ........................................................................................ 21
4.4 Electromagnetic Compatibility .......................................................................... 21
4.5 Basic Setup Procedure for the AR-6475 .......................................................... 22
4.6 How to Set Up Main Pump Tubing ................................................................... 23
4.7 How to Set Up the Two-Piece Tubing System ................................................. 24

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 Table of contents
4.8 How to Change the Brightness of the VFD ....................................................... 24
4.8.1 Pumps without a Rear Access Panel ........................................................................ 24
4.8.2 Pumps with a Rear Access Panel ......................................................................... 25
4.9 How to Change the Language Setting ................................................................. 25
4.9.1 Pumps without a Rear Access Panel ........................................................................ 25
4.9.2 Pumps with a Rear Access Panel ......................................................................... 26
4.10 How to Test the Power Supply Voltages and VFD ........................................ 26
4.11 Safe Setup and Performance ........................................................................ 26
4.11.1 Pressure Reading on the Display .......................................................................... 26
4 .1 1 .2 Abnormal Operation .............................................................................................. 27
4 . 1 1 .3 Overpressure Sensing ........................................................................................... 27
4 . 1 1 .4 Roller Housing ....................................................................................................... 28
4 .1 1 .5 Tubing Sensor Coupler ......................................................................................... 28
4.12 Shutdown Procedure .................................................................................... 28
5.0 Operation and Frequently Used Functions ........................................ 29
5.1 Initial Pressure Settings ................................................................................... 29
5.2 How to Operate the AR-6475 in Normal Mode ................................................. 30
5.3 How to Operate the AR-6475 in FLUSH Mode................................................. 31
6.0 Cleaning and Disinfecting .................................................................. 32
6.1 Console (AR-6475) .......................................................................................... 32
6.2 Remote Control Unit (AR-6476) ....................................................................... 32
6.3 Tubing .............................................................................................................. 33
7.0 Sterilization ........................................................................................ 34
8.0 Transmissible Spongiform Encephalopathy (TSE) ............................ 35
9.0 Maintenance ...................................................................................... 36
9.1 Life Expectancy ................................................................................................ 36
9.2 Periodic Maintenance ....................................................................................... 36
1 0 .0 Technical Support ........................................................................... 37
10.1 How to Display the Software Version ............................................................ 37
10.2 Additional Technical Information ................................................................... 37
1 1 .0 Troubleshooting .............................................................................. 38
11.1 Troubleshooting Interference with Other Devices ......................................... 39

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 Table of contents

1 2 .0 Limited Warranty ............................................................................. 40

1 3 .0 Repair Policy................................................................................... 41
1 4 .0 End of Life, Environmental Directives ............................................. 42
1 5 .0 Notes .............................................................................................. 44
Notes .......................................................................................................... 46

List of Figures
Figure 1 AR-6475 CWIII Front Panel of Console .............................................................................. 9
Figure 2 AR-6475 Synergy CWIII Front Panel of Console ............................................................... 9
Figure 3 AR-6475 Rear Panel OF Console (Without Access Panel) .............................................. 10
Figure 4 AR-6475 Rear Panel of Console (With Access Panel) ...................................................... 10
Figure 5 Remote Control Unit (AR-6476) ......................................................................................... 13
Figure 6 One Piece Tubing Configuration ....................................................................................... 14
Figure 7 Two Piece Tubing Configuration ....................................................................................... 15

List of Tables
Table 1 Front Panel Elements ............................................................................................................. 9
Table 2 Rear Panel Elements ............................................................................................................ 11
Table 3 Vacuum Fluorescent Display Messages AND Iconography.......................................... 11
Table 4 Measured Pressure (±5%) Readings in Bar Graph ......................................................... 12
Table 5 Remote Control Unit Elements (AR-6476) ........................................................................ 13
Table 6 Elements of the One Piece Tubing Configuration ........................................................... 14
Table 7 Elements of the Two Piece Tubing Configuration .......................................................... 15
Table 8 Tubing Set Correlation and Comparisons ........................................................................ 18
Table 9 Control Unit (AR-6475) Specifications .............................................................................. 19
Table 10 Ambient conditions for operation ..................................................................................... 19
Table 11 Ambient conditions for storage (in shipping packaging) .............................................. 19
Table 12 Remote Control Unit (AR-6476) Specifications ................................................................ 19
Table 13 Initial Pressure Settings ....................................................................................................... 29
Table 14 Troubleshooting: Faults, their Causes and Solutions...................................................... 38

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide

1.0 General Warnings and Safety Notices - Read This First

1.1 Important Safety and Conventions Information
It is imperative that the symbols and conventions listed below be clearly
understood. The Continuous Wave III Arthroscopy Pump User’s Guide identifies
critical, important, and useful information using these symbols and conventions.
Users of this device are encouraged to contact their Arthrex representatives if
they require a more comprehensive surgical technique.

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.
1. Use this device only for purposes described in the User’s Guide, under the
supervision of a trained and licensed physician.
2. 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.
3. 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.
4. This device is only for use in normal arthroscopic purposes as described in
the User’s Guide, under the supervision of a trained and licensed physician.
5. Failure to adhere to the set up 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 of the potential compromise in patient safety
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.
6. 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
set up 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.
7. No modification of the console (AR-6475) or accessories are allowed.

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide
8. Use this device only 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.
9. 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
dangerous high voltages or other risks. If the system malfunctions,
return it for service immediately.

10. To avoid the RISK of electric shock, this equipment must only be connected
to a SUPPLY MAIN with protective earth ground.
11. Do not have device in direct contact with patient if high-frequency devices
are in use, or if the patient requires defibrillation.
12. To assure that correct pressure monitoring occurs, the pump and operative
site MUST be in the same horizontal plane.
13. DO NOT stack or place equipment adjacent to the AR-6475 console if
possible. If such a configuration is necessary, carefully observe the
configuration in question to ensure that electromagnetic interference does not
degrade performance.
14. Use only Arthrex approved electronic 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 patient and/or
operating room staff injury.
15. 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
16. 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.
17. The Extension or Patient Tubing must be changed for each patient.
18. 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 assures its safe operation throughout the entire surgical day.
19. 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 measurements.

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide
20. The safety and effectiveness of the AR-6475 is verified and documented;
however, the AR-6475 must be used with an awareness of the risk of extra-
articular edemas for patients with pathologically changed articular capsules
and for procedures involving an opening of the capsule (e.g. lateral release)
21. 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.
22. 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.
23. 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.
24. User programmed “Pressure Set” values are increased by as much as 50%
to a maximum of 120 mmHg during the FLUSH function. Exercise caution to
avoid injury to the patient.
25. The Extension or Patient tubing must be replaced before each new surgical
procedure.
26. 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 unit by pulling on the cable.
Remove the remote control unit plug 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-6475 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 supply main.
4. Connecting an extension cord to the AR-6475 may result in a reduced level of
safety.
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.

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide
7. This device may cause interference to other devices in the near vicinity, if not
set up and used as Arthrex instructs.
8. Do not attach the remote control during Self Test or the Programming Modes.
9. 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.
10. NEVER use liquid to clean the accessory device connector contacts. Remove
dust regularly with dry compressed air.
11. Liquid on the cable connector of the accessory device can damage the
device. Before connecting the cable, ensure the receptacles are clean and
dry.
12. Always comply with the instructions issued by the manufacturer of the the
cleaning disinfectant regarding concentration, exposure times, temperature
and material compatibility.
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 for detailed remote control
(DFU-0144) 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. 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.

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide

1.2 Symbols Definition

Caution: Federal Law
Authorized Restricts this device
Representative in the
to sale by or on the
European Community
order of a Physician.

On / Off (push-push) Type BF Equipment

Precaution of Warning
Fragile
Notice

Keep Dry This Side Up

Electrical Hazard,
Dangerous Voltages
are Present. Never
attempt to repair the
Temperature Limits
equipment. Only
for Storage and
Trained Service
Transport
Personnel may remove
the cover, or obtain
access to system
components.

Pressure Limits for

Alternating Current
Storage and Transport

Humidity Limits for

Fuse
Storage and Transport

Equipotential Protective Earth

[Equipment Potential] Ground [Functional]

WEEE [Waste
Electronics and RF Symbol. Non-
Electrical Equipment] ionizing
Symbol. Regarding Electromagnetic
European Union End- Radiation
of-Life of Product.

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 General Warnings and Safety Notices - Read This First
Continuous Wave III Arthroscopy Pump User’s Guide

Date of Manufacture;
Manufacturer year and month.

The product meets the

essential
Provided Non Sterile requirements of
Medical Device
Directive 93/42/EWG

Catalog number Serial Number

Quantity

[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-6475. Each line drawing has its own
callout system to identify important elements of each product.

1.3 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. Warranty could be voided if shipping or first-
installation damage is not reported within 7 business days of receiving 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 made to the product or repairs are
completed 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.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

2.0 Product Description

2.1 Product Description and Intended Use
The Arthrex AR-6475 Continuous Wave III 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-
6475 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 set up 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 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 up 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 of the potential compromise in patient safety
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 purposes as described in the
User’s Guide, under the supervision of a trained and licensed physician.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide
The AR-6475 includes:
• A universal medical-grade switching power supply that allows the pump to
function automatically at voltage ranges found worldwide.

• Improved displays that combine both vacuum fluorescent and dot matrix
displays for high contrast and visibility.
• A reprogrammable microcontroller with upgradeable software that supports
multilingual messaging.
• Membrane switch overlays for user inputs and easier cleaning.
• A FLUSH function for providing elevated pressure to stop bleeding and flow
rate to clear joint spaces quickly.
The user-defined settings for pressure and flow are adjustable through controls
located on the console front panel or on the remote control.
There are three Applied Part pump tubing options for the AR-6475:
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 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.
The optional Y-Tubing connects up to four irrigation bags and can be used with
all AR-6475 pump tubing options.
Optional Accessory:
• Remote Control

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

2.2 Product Features

2.2.1 AR-6475 Console: Front View
Figure 1 and Figure 2 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 AR-6475 CWIII Front Panel of Console

Figure 2 AR-6475 Synergy CWIII Front Panel of Console

Table 1 Front Panel Elements

1 Tubing IN Guide (beneath the Green dot)/ Tubing OUT Guide
2 Green dot (for orienting the Pump Tubing)
3 Roller assembly
4 Roller housing door
5 Type “BF” shock hazard symbol
6 Vacuum Fluorescent Display (VFD)
7 Measured pressure bar graph
8 AC mains power toggle switch
9 Activate/Deactivate FLUSH function button
10 Pump motor Enable/Disable button

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide
11 Flow rate in percent
12 Flow buttons and symbol. Increase or decrease maximum fluid flow rate
to the joint space by ten percent on a scale of ten to 100 percent.
13 Target distention pressure in mmHg
14 Pressure Set buttons and symbol. Increase or decrease target pressure in
the joint space by one mmHg on a scale of zero to 120 mmHg.
15 Locking lever for roller housing door
16 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 present or that it is connected incorrectly.
17 Tubing sensor coupler

2.2.2 AR-6475 Console: Rear View

Figure 3 and Figure 4 uses an upper case letter 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 3 AR-6475 Rear Panel OF Console (Without Access Panel)

Figure 4 AR-6475 Rear Panel of Console (With Access Panel)

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

Table 2 Rear Panel Elements

A AC mains power plug socket and ratings
B Equipotential ground connector and symbol
C AR-6476 Remote Control connector and symbol
D Date of manufacture and serial number label
E Water ingress protection rating (IPX1)
F Access panel (on some units)

2.2.3 AR-6475 Vacuum Fluorescent Display Messages

The console’s Vacuum Fluorescent Display (VFD) [6] provides information about
the status of the AR-6475 and the pressure and flow settings in real time. Table 3
describes each message and button when pump is in ready state.

Table 3 Vacuum Fluorescent Display Messages AND Iconography

Message Cause Explanation

Arthrex AR-6475 Message displayed when the AC main power Power on message display
switch is activated.
* Check Tube * Message appears when tubing is not plugged Check tubing installation
into the Tubing Sensor Coupler [17].
* Door Not Closed * Message appears when the roller housing door Roller housing door is not
[4] is open. closed
* Over Pressure * Message appears when the sensed pressure Software overpressure
exceeds over-pressure software limit of 300 condition
mmHg.
Critical Failure Message appears on the first line of the VFD if Critical failure, cannot
one of three conditions is met: continue operation.
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.
* Power Failure * Message appears if the power supply self-test Power supply test fails.
fails when the pump is turned on.
* OVP Detect Fail * Message appears if the hardware overpressure Hardware overpressure
diagnostic test fails when the pump is turned on. diagnostic fails.
* Sensor Failure * Message appears if the pump detects a problem Sensor failure.
with the pressure sensors.
* Pressure Fault * Message appears when the pump is unable to Insufficient measured
reach a desired set pressure within a specific pressure.
amount of time. This typically indicates an
improperly installed tubing set or a split in the
tube from continuous use.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide
Message Cause Explanation
Remote Message appears when the remote is plugged in Remote connected
and remains a secondary message.
Pressure Set + Pressure set increase
Message appears when the PRESSURE SET
button is pressed.

Pressure Set - Pressure set decrease

Message appears when the PRESSURE SET
button is pressed.

Flow Set + Message appears when the FLOW button Flow increase
is pressed.
Flow Set - Message appears when the FLOW button Flow decrease
is pressed.
RUN/STOP Button Message appears when the RUN/STOP button is Motors on / Motors off
pressed.
Flush Flush feature enabled
Message appears when the button is pressed
for less than one second.
Pump On Message appears when the pump motor is on. Motor on and running
Pump On/Flush Message appears when the pump is in FLUSH Motor on and flushing
mode.
Pump Off Message appears when the pump motor is off. Motor off
Pump Paused Message appears when the pump is on and the Motor on but paused
measured pressure exceeds the target pressure.
Pump Paused/Flush Message appears when the pump is in FLUSH Pump flushing but paused
mode and the measured pressure exceeds the
flush pressure.
Self Test V X.XX Message appears prior to running a self-test. Pump self-test
Power Supplies OK Message appears after a successful power supply Power supply test passed
test.

2.2.4 Measured Pressure Bar Graph

The console’s Measured Pressure Bar Graph [7] uses twenty colored LEDs that
illuminate to display the sensed pressure information in real time. Table 4
summarizes the segments, their colors, and the corresponding sensed pressure
ranges.

Table 4 Measured Pressure (±5%) Readings in Bar Graph

SEGMENTS COLOR MEASURED PRESSURE RANGE DISPLAYED
1-13 Green 8 mmHg to 98 mmHg
14-16 Yellow 105 mmHg to 120 mmHg
17-20 Red 128 mmHg to 150 mmHg

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

2.3 Remote Control Unit (AR-6476)

The AR-6475 Continuous Wave III Arthroscopy Pump can be remotely
controlled with the optional, autoclavable Remote Control Unit (AR-6476). It
provides the ability to control pressure adjustments; flow adjustments; Flush;
and the ability to activate and deactivate the pump motor. The remote control
unit’s cable is 9.8 feet (3 meters) 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 5 uses a lowercase 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 5 Remote Control Unit (AR-6476)

Table 5 Remote Control Unit Elements (AR-6476)

i. Flow buttons and symbol. Increase or decrease maximum fluid

flow rate to the joint space by ten percent on a scale of ten to 100
percent.
ii. Pressure Set buttons and symbol. Increase or decrease target
pressure in the joint space by one mmHg on a scale of zero to 120
mmHg.
iii. Activate/Deactivate FLUSH function.
iv. Pump motor Enable/Disable switch.
v. Lemo connector to attach to the corresponding plug on the rear
panel [C] of the AR-6475.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

2.4 Tubing
2.4.1 Tubing Configurations
Figure 6 and Figure 7 show the tubing combinations supported by the
AR-6475.

Figure 6 One Piece Tubing Configuration

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 AR-6410/AR-6415
fluctuations
g. Sensor chamber AR-6410/AR-6415
h. Connector fittings AR-6410/AR-6415
AR-6220
i. Backflow check valve AR-6220

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

Figure 7 Two Piece Tubing Configuration

Table 7 Elements of the Two Piece Tubing Configuration

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

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide
2.4.2 Main Pump Tubing Set (AR-6410: Region A)
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 pump tubing is 13 feet (4.0 meters) in
length.
NOTE: This User’s Guide assumes that the AR-6410 is used alone or in
combination with the AR-6220, described below. For specific
information about each tube set, refer to the Directions for Use that are
included with each set or contact your Arthrex representative.

2.4.3 Extension 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 8
feet (2.4 meters) in length.

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

The ReDeuce Pump Tubing Set is intended to be used in conjunction with
the ReDeuce Patient Tubing Set (AR-6421) to offer inflow and pressure
measurement tubing. It is not intended to be used stand-alone. The
ReDeuce Pump Tubing Set may be used for an entire surgical day, unless
sterility is compromised in any way. From the pump the tubing is 1.7
feet (0.5 meters) in length

2.4.5 ReDeuce Patient Tubing (AR-6421: Region A)

The ReDeuce Patient Tubing is intended to be used in conjunction with
the ReDeuce Pump Tubing Set to allow the use of the ReDeuce Pump
Tubing Set for an entire surgical day, while replacing only the ReDeuce
Patient Tubing after each individual surgery. The backflow check valve
built into the ReDeuce Patient Tubing Set prevents contaminated fluid
from back-flowing into the ReDeuce Pump Tubing Set, maintaining a
closed sterile fluid environment during tubing replacements. The
patient tubing is 8 feet (2.4 meters) in length.

2.4.6 One Piece Tubing Set System

(AR-6415/AR-6415CL: Region B)
The One Piece Tubing System offers inflow and pressure measurement
tubing. The One Piece Tubing System is intended to be used for ONLY
one procedure and must be replaced after each patient.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide
The only difference between the AR-6415 and the
AR-6415CL model is that the bag spikes on the “CL” model are
CareLock spikes which are used specifically with Fresenius fluid bags.

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

The Main Pump Tubing Set is intended to be used in conjunction with
the Patient Extension Tubing System (AR-6425) to offer inflow and
pressure measurement tubing. It is not intended to be used stand-
alone.
The Main Pump Tubing Set may be used for an entire surgical day when
used in conjunction with the Patient Extension Tubing System (AR-6425),
unless sterility is compromised in any way.
The only difference between the AR-6420 and the AR-6420CL model is
that the bag spikes on the “CL” model are CareLock spikes which are
used specifically with Fresenius fluid bags.
2.4.8 Patient Extension Tubing System (AR-6425: Region B)
The Patient Extension Tubing System is used in conjunction with the Main
Pump Tubing Set (AR-6420/AR-6420CL) to allow the Main Pump Tubing
Set to be used for an entire surgical day, while only replacing the Patient
Extension Tubing System after each individual surgery. The Patient
Extension Tubing System is intended to be used in conjunction with the
Main Pump Tubing Set (AR-6420/AR-6420CL) to allow the use of the
Main Pump Tubing Set for an entire surgical day, while replacing only
the Patient Extension Tubing System after each individual surgery. The
backflow check valve built into the Patient Extension Tubing System
prevents contaminated fluid from back-flowing into the Main Pump
Tubing Set, maintaining a closed sterile fluid environment during tubing
replacements.

2.4.9 Y-Adapter Tubing (AR-6215)

The optional Y-Adapter Tubing is intended to be used with all the
Arthrex tubing sets/system combinations to connect up to four
irrigation bags).
For more details on which tubing configuration are available in each your area,
contact your Arthrex representative.

NOTE: Refer to the Instructions for Use package insert for detailed tubing
(DFU-0140/DFU-0140G) instructions included with each tubing set.
Additional copies of this insert can be obtained from the Arthrex website
at www.arthrex.com, or by contacting your local Arthrex Representative.

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 Product Description
Continuous Wave III Arthroscopy Pump User’s Guide

Table 8 Tubing Set Correlation and Comparisons

Region A Region A Region B Region B

Tubing Set Tubing Set Tubing Set Tubing Set
Part Number Description Part Number Description

AR-6410 Main Pump Tubing Set AR-6415 One Piece Tubing System
(Can be used stand-alone or AR-6415CL * One Piece Tubing System with
in conjunction with the AR- CareLock bag spikes
6220 Extension Tubing Set) (Used stand-alone)

AR-6220 Extension Tubing Set

(Can be used in conjunction
with the
AR-6410 Main Pump
Tubing Set as an additional
extension)

AR-6411 ReDeuce Tubing Set AR-6420 Main Pump Tubing Set

(MUST be used with the AR-6420CL * Main Pump Tubing Set with CareLock
AR-6421 ReDeuce Patient bag spikes
Tubing Set) (MUST be used with the AR-6425
Patient Extension Tubing Set)

AR-6421 ReDeuce Patient Tubing AR-6425 Patient Extension Tubing Set

(MUST be used with the (MUST be used in conjunction with the
AR-6411 ReDeuce Tubing AR-6420/AR-6420CL Main Pump
Set) Tubing Set)

AR-6215 Y-Tubing Adapter

* CL = CareLock: Tubing spike used mainly for Fresenius fluid bags.

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 Technical Specifications
Continuous Wave III Arthroscopy Pump User’s Guide

3.0 Technical Specifications

3.1 Console
Table 9 Control Unit (AR-6475) Specifications
Width 14.5 inches (36.5 cm)
Height 5.0 inches (12.5 cm)
Depth 12 inches (30 cm)
Weight 18 pounds (8.2 kg)
Maximum Flow rate 1500 ml/minute
Pressure 10 – 120 mmHg increments of 5 mmHg.
Overpressure control 300 mmHg
Pressure control Continuous pressure checking
Protection IPX1
Main cable 10 A/250 V
Connector CEE 7/7
Jack IEC 320/C13
Power supply 100-240 V, 50/60 Hz, 6.5A
Mains Fuse T2.0A 250V
Applied Part Type BF
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 158°F (-30° to +70°C)
Relative Humidity 10% to 90%, non-condensing

3.2 Remote Control

Table 12 Remote Control Unit (AR-6476) 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

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide

4.0 Setup
4.1 How to Set Up the Console
Users are encouraged to contact their Arthrex representative if they require a
more comprehensive surgical technique.
NOTE: To minimize the effects of hydrostatic pressure differences on the actual
joint pressure, both the pump and joint must be in the same horizontal
plane.

4.2 AC Power Safety Considerations

The AR-6475 is powered by a medically rated universal AC input switching
power supply. This power supply allows users to connect the console to any
local AC mains outlet. Please use the appropriate plug and a reliable ground
conductor.
Arthrex supplies separate power cords for the U.S. and Europe CEE 7/7 with the
AR-6475. Contact your Arthrex representative if you need a power cord that
must meet the electrical standards of another country.

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-6475 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 supply main.

NOTE: Extension cords must meet local electrical standard. Extension cords
are not recommended to be used with the AR-6475.

Connecting an extension cord to the AR-6475 may result in a

reduced level of safety.

The console is designed to meet power-saving guidelines. The console has an AC

mains switch on the front panel [8]. 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 completion of these tests, the console displays on the VFD
[6] the name and model number, Arthrex CONTINUOUS WAVE III. If the tests
discover a problem, an error message shows on the VFD. Refer to Table 3 for a
complete list of VFD Messages.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
In the event of an AC power interruption, the console can run continuously
without fault for up to 10 milliseconds. If an AC power failure lasts longer than
10 milliseconds, the system will reset to default settings when AC power is
restored.

W A R N I N G !
To avoid the RISK of electric shock, this equipment must only be connected to a
SUPPLY MAIN with protective earth ground.

W A R N I N G !
Do not have device in direct contact with patient if high-frequency devices are in
use, or defibrillation of the patient is required.

4.3 Replacing the Fuses

Main fuse replaced with T2.0A 250V as follows:
1. Disconnect the device from the AC mains.
2. Open the fuse tray in the AC inlet, by pulling on the tabs.
3. Replace the fuses with T2.0A 250V Line Fuses as noted on the rear panel.
4. Push the fuse holder back into the AC inlet.
5. Ensure that fuse holder is fully seated and that the tabs snap back.

Always use fuses with the correct values to avoid allowing

overcurrent to enter the system.

An incorrect fuse may increase the risk of electrical shock or fire

hazard.

NOTE: The AR-6475 console incorporates a universal AC input power supply.

A voltage selection switch is not required.

4.4 Electromagnetic Compatibility

This device may cause interference to other devices in the near
vicinity, if not set up and used as Arthrex instructs.

AR-6475 has been designed to accept EMC from other devices within the
limitations.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
To determine if the AR-6475 is causing interference to other devices, power OFF
the AC mains power switch [8] 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 between devices.
3. Connect the device to an outlet on a different circuit than the other
device(s) are connected.
4. Consult the manufacturer or field service technician for the receiving
device for guidance.

4.5 Basic Setup Procedure for the AR-6475

W A R N I N G !
To assure that correct pressure monitoring occurs, the pump and operative site
MUST be in the same horizontal plane.

NOTE: Section 5.0, Operation, explains how to use the pump.

1. Place the AR-6475 on a flat, dry surface in the same horizontal plane
as the operative site, such as the AR-6481 Arthrex Arthroscopy pump
cart.
2. Connect the receiver end of the power cord for the AR-6475 into the
AC socket [A] and the plug end to the facility AC mains supply.
3. Turn on the AR-6475 [8].
4. Verify the status of the AR-6475 displayed in the VFD [6].
5. Connect the tubing in accordance with Section 4.6 or 4.7
6. Close the roller housing door and locking lever [4, 15].
7. Attach the Remote Control Unit, if applicable [v, C].
8. Refer to Section 5.0, Operation, for specific information on how to
operate the AR-6475, including pressure and flow settings.
9. Press the Run/Stop button [10 or vi] to activate the pump motor.

W A R N I N G !
DO NOT stack or place equipment adjacent to the AR-6475 console if possible. If
such a configuration is necessary, carefully observe the configuration in question
to ensure that electromagnetic interference does not degrade performance.

Do not attach remote control during Self Test or the Programming

Modes.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide

W A R N I N G !
Use only Arthrex approved electrical 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 patient and/or operating room staff
injury.

W A R N I N G !
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.

W A R N I N G !
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.

4.6 How to Set Up Main Pump Tubing

NOTE: These instructions describe the procedure to set up the AR-6410, AR-
6415, AR-6411 or AR-6420.
1. Remove the orange clip from the Pump Tubing and insert the
Pressure Line Connector [e] of the Pump Tubing into the Tubing
Sensor Coupler [17]. This step must be completed first to ensure
accurate pressure measurements.
2. Open the inflow door completely. Allow the door to rest against the
stop. The roller mechanism is now exposed.
3. Place the green-collared section of the Pump Tubing [c] into the
Inflow Tubing Track [1] indicated by the green dot.
4. Guide the tubing boot [d] over the rollers and insert the output side of
the tubing boot into the Tubing OUT Guide.
NOTE: The Pump Tubing is connected properly when the green connector [c]
on the Pump Tubing is aligned with the green dot [2] on the front panel
of the console.
5. Close the inflow door.
NOTE: The inflow door locking device must be secure. If the door is not closed
securely an internal safety switch prevents the AR-6475 from operating.
6. Puncture the fluid bags with the spikes on the tubing. If only one fluid
bag is being used, seal the second fluid line by closing the clamp
nearest the unused spike.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide

4.7 How to Set Up the Two-Piece Tubing System

NOTE: These instructions describe the procedure to set up the AR-6421,
AR-6425 or AR-6220.

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 6 or k to k in Figure 7].
3. 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
Tubing Set.

W A R N I N G !
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
assures its safe operation throughout the entire surgical day.

4.8 How to Change the Brightness of the V F D

The VFD supports four levels of brightness. The brightest setting is 1, which is
the default. The dimmest setting is 4. To change the brightness of the VFD,
follow these instructions:

4.8.1 Pumps without a Rear Access Panel

1. Power OFF the AC main power switch [8] on the AR-6475.
2. Press and hold—simultaneously—the PRESSURE SET [14] and FLOW
[12] buttons while powering ON the AC main power switch [8]. The
following message will appear on the console’s VFD [6]:
Prog Mode: BRIGHTNESS 1
3. Press the FLOW [12] or FLOW buttons to cycle through the
brightness settings. Repeat until the desired brightness setting appears on the
console’s VFD [6].

4. Press [10] to set the brightness.

5. Power OFF [8] the AR-6475.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
6. Power ON [8] the AR-6475. The new brightness setting is in use.

4.8.2 Pumps with a Rear Access Panel

1. Power OFF the AC main power switch [8] on the AR-6475.
2. Press and hold the PRESSURE SET [14] button while powering ON the
AC main power switch [8]. The following message will appear on the
console’s VFD [6]:
ADJUST INTENSITY
3. Press the FLOW [12] or FLOW buttons to cycle through the
brightness settings. Repeat until the desired brightness setting appears on
the console’s VFD [6].

4. Press [10] to set the brightness.

5. Power OFF [8] the AR-6475.
6. Power ON [8] the AR-6475. The new brightness setting is in use.

4.9 How to Change the L ang uag e S etting

The AR-6475 supports English, French, German, Italian, and Spanish. The
default language is English. To change the language setting for VFD messaging,
follow the instruction below:

4.9.1 Pumps without a Rear Access Panel

1. Power OFF the AC main power switch [8] on the AR-6475.
2. Press and hold—simultaneously—the PRESSURE SET [14] and FLOW
[12] buttons while powering ON the AC main power switch [8]. The
following message will appear on the console’s VFD [6]:
PROG MODE: BRIGHTNESS 1

3. Press and release the button [10] to bypass the Brightness Adjustment
Mode and switch to the Language Adjustment Mode. The following message
will appear on the console’s VFD [6]:
PROG MODE: LANGUAGE ENGLISH
4. Press the FLOW [12] or FLOW buttons to cycle through the
language settings. Repeat until the desired language appears on the
console’s VFD [6].

5. Press [10] to set the language.

6. Power OFF [8] the AR-6475.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
7. Power ON [8] the AR-6475. The new language setting is in use.

4.9.2 Pumps with a Rear Access Panel

1. Power OFF the AC main power switch [8] on the AR-6475.
2. Press and hold the PRESSURE SET [14] button while powering ON the
AC main power switch [8]. The current language will appear on the
console’s VFD [6]:
ENGLISH
3. Press the FLOW [12] or FLOW buttons to cycle through the
language settings. Repeat until the desired language appears on the
console’s VFD [6].

4. Press [10] to set the language.

5. Power OFF [8] the AR-6475.
6. Power ON [8] the AR-6475. The new language setting is in use.

4.10 How to Test the Power Supply Voltages and VFD

1. Power OFF [8] the AR-6475.
2. Press and hold the FLOW [12] button while powering ON the AC main
power switch [8]. The following message will appear on the console’s
VFD[6]:
Self Test Vx.x
Vx.x is the version of the firmware self test.
The self test is comprised of two parts. The first test checks the VFD by
illuminating all of the pixels and then displaying a series of digits. The VFD
must be visually inspected to verify that all characters are legible and of the same
brightness.
The second test verifies that the power supply voltages are within tolerance and
that the hardware overpressure protection circuit is running as a backup to the
software protection. The following message will appear on the console’s VFD
after successful completion of the tests:
Power Supplies OK

4.11 Safe Setup and Performance

4.11.1 Pressure Reading on the Display
The pump runs as an open system in nearly all applications. This means inflow
and outflows are open (the outflow on the sheath or the outflow over the optical
and working portals).

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
Under this system, the 50 mmHg shown on the display corresponds to the actual
pressure in the joint. If there is a fall in pressure, the pump increases pressure up
to 50 mmHg and then stops.
In contrast, a closed system has a100% impermeable joint and no egress of water
through the portals. For example, at a pressure measurement at the end of the
applied part a dynamic pressure arises here which is increased by a factor of 2.2
(at a setting of 50 mmHg , the maximum is 110 mmHg). The pump stops when
this value is reached.

Joint Pressure reading on Actual pressure in Theoretical

display open systems maximum pressure
in closed systems
Knee 35 – 60 mmHg 35 – 60 mmHg 77 – 132 mmHg
Hip 35 – 60 mmHg 35 – 60 mmHg 77 – 132 mmHg
S houlder 60 – 80 mmHg 60 – 80 mmHg 132 – 176 mmHg
S m all joints 50 – 70 mmHg 50 – 70 mmHg 110 – 154 mmHg
Overpressure 136 mmHg 136 mmHg 300 mmHg

4.11.2 Abnormal Operation

The AR-6475 employs a dual-pressure sensor design. Microcontroller-based
internal circuitry monitors the sensors, as well as other circuit parameters, to
ensure that the pump remains within normal operating limits. In the event of a
fault, the pump motor is automatically disabled and an error message is
displayed on the VFD [6]. See Table 3 for a complete list of VFD 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 description of the malfunction. Prior to
shipment, it is necessary to obtain a Return Authorization Number from
Arthrex.

4.11.3 Overpressure Sensing

The sensing circuitry in the AR-6475 measures the pressure of the fluid in the
tubing. The overpressure alarm can be activated when the flow is abruptly
interrupted or the joint is suddenly positioned in a way which reduces the joint
capsule volume (e.g., bending the knee joint to the “Figure 4” position).
If an overpressure event occurs (300 mmHg), a warning message reading *Over
Pressure* will flash on the VFD and an audible alarm will sound. The pump
motor is automatically disabled until the pressure returns to the set range.
To reduce the pressure in a joint, open an outflow and/or manipulate the joint to
a stress-free position.

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 Setup
Continuous Wave III Arthroscopy Pump User’s Guide
4.11.4 Roller Housing
The pump motor automatically deactivates when the roller housing door is
opened. A locking mechanism prevents access to the rotating parts while the
device is operating.

4.11.5 Tubing Sensor Coupler

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 it must be replaced. Do not attempt
to reconnect the tubing to the pump as it could lead to unreliable pressure
measurements.

4.12 Shutdown Procedure

The AR-6475 can be safely shut down at any time by powering down the console.
All tubing accessories must be discarded as a biohazards waste.

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 Operation and Frequently Used Functions
Continuous Wave III Arthroscopy Pump User’s Guide

5.0 Operation and Frequently Used Functions

Users of this device should contact their Arthrex representative if they require a more
comprehensive surgical technique.

5.1 Initial Pressure Settings

W A R N I N G !
The safety and effectiveness of the AR-6475 is verified and documented;
however, the AR-6475 must be used with an awareness of the risk of extra-
articular edemas for patients with pathologically changed articular
capsules and for procedures involving an opening of the capsule (e.g.
lateral release).
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.
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 Continuous Wave III 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. Normally, pressure settings of 10 mmHg above
the patient’s diastolic pressure are adequate to control capillary bleeding.
The ideal intra-articular pressure depends on the indications for the arthroscopic
procedure, bleeding tendency, and the possibility of ischemia.

Table 13 Initial Pressure Settings

Knee arthroscopy 35
Shoulder arthroscopy 50
Small joint arthroscopy 40
Hip arthroscopy 45

All settings are based on the use of a high-flow sheath or secondary inflow portal
(suprapatellar, etc.).
To obtain a clear fluid environment, slowly increase distention pressure
beginning with the initial pressure settings in Table 13.

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 Operation and Frequently Used Functions
Continuous Wave III Arthroscopy Pump User’s Guide

W A R N I N G !
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.

5.2 How to Operate the AR-6475 in Norm al Mode

W A R N I N G !
The Extension or Patient Tubing must be replaced before each new surgical
procedure.

1. After adjusting the required pressure using the Pressure Set buttons
[14 or ii], remove the cap from the patient end of the tubing.
2. Open all appropriate tubing clamps.

3. Activate the pump motor by pressing [10 or iv].

4. Fill the entire length of the tubing with fluid to remove any air
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 [3] 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 continuously, the pressure line connector [e] or
sensor chamber [g] may not be functioning properly. Replace the
Pump Tubing.
6. Connect the tubing to the inflow cannula.
NOTE: A high-flow arthroscope sheath should be used for optimum flow when
rinsing through the inflow cannula.
7. Open the clamp on the tubing to release the flow.
Once the set pressure is reached, the pump will reduce flow to
maintain the set pressure. When the pressure drops, the flow
automatically increases until the set pressure is achieved. If the set
pressure cannot be attained, (no fluid restriction at the end of distal
end of tubing) flow will not exceed the user setting.
8. When the procedure is completed, close all clamps and disable the
pump motor [10].

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 Operation and Frequently Used Functions
Continuous Wave III Arthroscopy Pump User’s Guide

5.3 How to Operate the AR-6475 in FLUSH Mode

The AR-6475 pump has a FLUSH function for hemostatic purposes.

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 and hold down the button [9 or iii] for one second to enable this
function. The following message will be displayed on the VFD [6]:
Pump On/Flush

2. Press and hold the button for continuous FLUSH operation. The
FLUSH function only operates while the button is pressed. When in FLUSH
mode, the pump maximum flow rate increases to 100 % and the pressure

increases by 50% to a maximum of 120 mmHg. Release the button [9 or

iii] to disable this function and return to Normal Mode with the pre-FLUSH
pressure and flow settings.

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 Cleaning and Disinfecting
Continuous Wave III Arthroscopy Pump User’s Guide

6.0 Cleaning and Disinfecting

6.1 Console (AR-6475)
The AR-6475 console is provided non-sterile and must
not be sterilized.
The AR-6475 console can be cleaned/disinfected using a cloth and commercially
available surfactants or surface disinfectants only. Use a commercially available
cleaning disinfectant for surfaces. Alkaline agents with a pH value > 8 are to be
avoided. The AR-6475 must not be submersed in any liquid.
Always place the Main Power Switch [8] to “Off (O), position” and disconnect
the power before cleaning the AR-6475 console.
Always comply with the instructions issued by the manufacturer of
the cleaning disinfectant regarding 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 the device.

6.2 Remote Control Unit (AR-6476)

Refer to the Instructions for Use package insert for detailed remote
control (DFU-0144) 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.
The Remote Control Unit (AR-6476) is supplied non-sterile.
The Remote Control Unit can be autoclaved for sterilization.
The Remote Control Unit 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 accessory device connector

contacts. Remove dust regularly with dry compressed air

Do NOT clean the device with abrasive cleaning or disinfectant

compounds, solvents, or other materials that could scratch or
damage the device.

DFU-0218 Rev. 1 Page 32 of 47

 Cleaning and Disinfecting
Continuous Wave III Arthroscopy Pump User’s Guide

6.3 Tubing
The tubing is supplied pre-packaged sterile by EO sterilization. Do not re-
sterilize.

W A R N I N G !
The Extension or Patient tubing must be replaced before each new surgical
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 cover
the Pump Tubing Set connector after each surgical procedure to maintain
sterility and assure safe use throughout the entire surgical day.

DFU-0218 Rev. 1 Page 33 of 47

 Sterilization
Continuous Wave III Arthroscopy Pump User’s Guide

7.0 Sterilization
Sterilization capabilities, cleaning, disinfecting, handling, and storage of instrumentation
are the responsibility of qualified facility and/or user personnel. Qualified personnel
must still properly clean and disinfect the instruments prior to sterilization.

Refer to the Instructions for Use package insert for detailed Remote
Control (DFU-0144) 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.

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.

Liquid on the 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.

DFU-0218 Rev. 1 Page 34 of 47

 Transmissible Spongiform Encephalopathy (TSE)
Continuous Wave III Arthroscopy Pump User’s Guide

8.0 Transmissible Spongiform Encephalopathy (TSE)

It is outside the scope of this document to describe in detail the precautions that should
be taken for Transmissible Spongiform Encephalopathy (TSE) Agents.
The agents for transmission of Creutzfeldt-Jakob disease 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 handling
instruments that have been used on known, suspected, or at risk patients.
References:
ANSI/AAMI ST79: Good Hospital Practice: Steam sterilization and sterility assurance.

DFU-0218 Rev. 1 Page 35 of 47

 Maintenance
Continuous Wave III Arthroscopy Pump User’s Guide

9.0 Maintenance
Regular and proper maintenance of your Continuous Wave III Arthroscopy Pump is the
best way to protect your investment and avoid non-warranty repairs.
Recommended care and handling of the Continuous Wave III Arthroscopy Pump
includes proper day-to-day operation, cleaning, and sterilization which are extremely
important to ensure safe and efficient operation. It is important to visually inspect the
tubing, remote control, cable and connectors before each use.
Your authorized Arthrex service department is the most knowledgeable about the
Arthrex Continuous Wave III Arthroscopy Pump, tubing and remote control and will
provide competent and efficient service. Any services and/or repairs done by any
unauthorized repair facility may result in reduced performance of the instruments or
instrument failure.

9.1 Life Expectancy

The standard warranty for this product is twelve months.

9.2 Periodic Maintenance

The product should be inspected prior to and after each use to ensure that the
remote control, cable, strain relief, overmold, or connector contacts are not
damaged or worn. If it becomes necessary to return the remote control to Arthrex
for service, please sterilize the remote control before shipping.

DFU-0218 Rev. 1 Page 36 of 47

 Technical Support
Continuous Wave III Arthroscopy Pump User’s Guide

10.0 Technical Support

For assistance in using the products identified in this User’s Guide, contact an Arthrex
representative or contact the Arthrex Technical Support Hotline at 1-(888) 420-9393,
Monday through Friday from 9:00 AM to 5:00 PM EST; at +49 8131 5957 803 or
techsupport@arthrex.de from 8:00 AM to 5:00 PM CET.

10.1 How to Display the Software Version

Technical Support may request the software version of the pump. Follow these
instructions to display the software version.
1. Power On the AC mains power switch [8] on the AR-6475.
2. The software version is displayed on the VFD [6] during the power-
up sequence.

10.2 Additional Technical Information

Contact your Arthrex representative if you require more comprehensive
technical information. Pressure Verification Procedure, Circuit diagrams,
component part lists, descriptions, calibration instructions, or other information
can accessed at: www.Arthrex.com or will be provided upon request by Arthrex
APPROVED SERVICE PERSONNEL.

DFU-0218 Rev. 1 Page 37 of 47

 Troubleshooting
Continuous Wave III Arthroscopy Pump User’s Guide

11.0 Troubleshooting
Refer to Table 14 for device troubleshooting if problems occur after cleaning,
transporting or changing operating staff.

Table 14 Troubleshooting: Faults, their Causes and Solutions

Message Cause
* Critical Failure * 1. Return to Arthrex for repair.
* Door Not Closed * 1. Roller Housing not secured – ensure locking lever is properly secured.
2. If failure remains, return to Arthrex for repair.
* Overpressure * 1. Increase or open outflow.
2. Manipulate joint to stress-free position.
3. If failure remains, return to Arthrex for repair.
* Pressure Fault * 1. Ensure adequate fluid supply.
2. Decrease outflow.
3. Check tubing for damaged and if it is pinched, kinked or blocked.
4. Check tubing for proper connections.
5. Replace tubing.
6. If failure remains, return to Arthrex for repair.
* Check Tube * 1. If tubing sensor indicator’s LED is red then tubing is not properly connected.
2. Ensure tubing sensor coupler [17] is open not seated.
3. Ensure that the tubing pressure line connector [e] is seated completely.
4. Change tubing.
5. If failure remains, return to Arthrex for repair.
Console fails Self 1. Ensure no tubing is connected to the pump during power on sequence.
Diagnostic Test 2. If failure remains, return to Arthrex for repair.
Console will not power 1. Check AC mains power cord.
up 2. Try alternate power outlet.
3. Check AC mains fuses.
4. If failure remains, return to Arthrex for repair.
Does not pump when 1. Check for error messages.
activated 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.
Inadequate distention, 1. Increase pressure.
liquid bloody or cloudy 2. Activate Flush mode.
3. Reduce outflow.
4. Use high-flow cannulas.
5. If failure remains, return to Arthrex for repair.
No (or inadequate) flow 1. Check for error messages.
2. Check that all tubing clamps are open.
3. Check the settings for flow and pressure.
4. Check if the tubing is pinched, kinked or blocked.
5. Check that tubing seats correctly over the rollers.
6. Verify use of high-flow cannulas.
7. If failure remains, return to Arthrex for repair.

DFU-0218 Rev. 1 Page 38 of 47

 Troubleshooting
Continuous Wave III Arthroscopy Pump User’s Guide
If the problems persist, disinfect the Continuous Wave III Arthroscopy Pump and send
in to Arthrex using the original packaging. Always send the corresponding console
together with the tubing and remote control. Please enclose a brief explanation of the
detected malfunction. Refer to Section 13.0 for more information.

11.1 Troubleshooting Interference with Other Devices

Try one or more of the following to correct interference:
• Reorient or relocate the receiving device.
• Increase the distance between devices.
• Connect the device to an outlet on a different circuit than the other device(s).
• Consult the manufacturer or field service technician for the receiving device
for assistance.

DFU-0218 Rev. 1 Page 39 of 47

 Limited Warranty
Continuous Wave III Arthroscopy Pump User’s Guide

12.0 Limited Warranty

For a period of one (1) year after delivery of the Equipment and subject to the terms
hereof, Arthrex warrants the Equipment to be free from manufacturers’ defects in
material and craftsmanship under normal use and service. The Warranty does not apply
to any Equipment that has been repaired, serviced or altered outside of the
manufacturer’s or Arthrex’s facility or to Equipment that has been subjected to abuse,
misuse, neglect, accident or negligence in use, storage or handling. Arthrex’s obligation,
and the Customer’s sole and exclusive remedy, is limited to the replacement or repair of
any Equipment which Arthrex’s examination shall disclose, in its sole discretion, to be
defective or inoperative, and will be conditioned upon Arthrex’s receiving written notice
of any alleged nonconformity or defect during the applicable warranty period and the
return of defective products to Arthrex, F.O.B. Arthrex’s facility. 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 to the original Customer and is not transferable except at the
discretion of Arthrex. Repairs and replacements made under this warranty are not
warranted beyond the remainder of the warranty period. ARTHREX’S LIABILITY
SHALL BE LIMITED SOLELY, AT ARTHREX’S OPTION, TO REPAIR OR
REPLACEMENT OF THE GOODS OR COMPONENT PARTS NOT MEETING THE
QUALITY AND SPECIFICATIONS WARRANTED. THERE ARE NO WARRANTIES,
IMPLIED OR STATUTORY (INCLUDING THE WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR INTENDED USE,
NON-INFRINGEMENT, OR ARISING OUT OF A COURSE OF PERFORMANCE,
DEALING OR TRADE USAGE) THAT EXTEND BEYOND THIS EXPRESS
WARRANTY. IN THE EVENT THAT APPLICABLE LAW PREVENTS THE
DISCLAIMER OF ANY IMPLIED WARRANTIES, THEN SUCH IMPLIED
WARRANTIES SHALL BE LIMITED TO THE CONTENTS AND DURATION OF THIS
EXPRESS WARRANTY.

DFU-0218 Rev. 1 Page 40 of 47

 Repair Policy
Continuous Wave III Arthroscopy Pump User’s Guide

13.0 Repair Policy

Contact Arthrex for a Return Authorization Number and instructions prior to returning
the device.

DFU-0218 Rev. 1 Page 41 of 47

 End of Life, Environmental Directives
Continuous Wave III Arthroscopy Pump User’s Guide

14.0 End of Life, Environmental Directives

WEEE Directive [2002/96/EC] on Waste Electrical and Electronic

Equipment

The Directive on Waste Electrical and Electronic Equipment obliges manufacturers,

importers, and/or distributors of electronic equipment to provide for recycling of the
electronic equipment at the end of its useful life.

Do not dispose of WEEE in unsorted municipal waste.

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 conserve natural resources and ensure
that it is recycled in a manner that protects human health and the environment. For
more information about where you can drop off your medical endoscopic video
equipment at the end of its useful life for recycling, please contact Arthrex Customer
Service Department.

DFU-0218 Rev. 1 Page 42 of 47

 End of Life, Environmental Directives
Continuous Wave III Arthroscopy Pump User’s Guide

DFU-0218 Rev. 1 Page 43 of 47

 Notes
Continuous Wave III Arthroscopy Pump User’s Guide

15.0 Notes

DFU-0218 Rev. 1 Page 44 of 47

 Notes
Continuous Wave III Arthroscopy Pump User’s Guide

Notes

DFU-0218 Rev. 1 Page 45 of 47

 Notes

DFU-0218 Rev. 1 Page 46 of 47

 1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Customer Service
1-(239) 643-5553

Arthrex, Inc.
Toll-Free Technical Support: +1-(888) 420-9393,
Monday through Friday, 9:00 AM – 5:00 PM ET.
Fax: +1-(239) 598-5534
www.arthrex.com

Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0
www.arthrex.de

All rights reserved. Printed in USA

0086

DFU-0218 Rev. 1 Page 47 of 47