Arthrex AR-6480 User manual

DualWave
Arthroscopy Pump
AR-6480
User’s Guide
The Arthrex DualWave Arthroscopy Pump User’s Guide provides
safety operation information for all components of the Arthrex
DualWave Arthroscopy Pump (Model AR-6480), including
accessories. All operating personnel must read this User’s Guide
thoroughly prior to using this system and follow all safety
warnings, cautions, and precautions.
U.S. PATENT No. 5,520,638
0086
Arthrex, Inc.
Naples, FL 34108-1945 USA
Toll Free: 800 934-4404
www.arthrex.com
Arthrex Med. Inst. GmbH
85757 Karlsfeld, Germany
Telephone: [phone]
www.arthrex.de
LM1-0630-EN_E
© 2012 Arthrex, Inc. All rights reserved.

Table of contents
LM1-0630-EN_E Page i of 43
1.0 Read This First .....................................................................................1
Important Safety Information..............................................................................11.1
Important Symbols and Conventions .................................................................21.2
Shipping, Unpacking and Warranty Information.................................................41.3
Product Description ..............................................................................52.0
Product Description and Intended Use...............................................................52.1
Product Features................................................................................................62.2
AR-6480 Console: Front View................................................................................62.2.1
AR-6480 Console: Rear View ................................................................................72.2.2
AR-6480 Display Messages...................................................................................82.2.3
Foot Pedal Unit (AR-6483)...............................................................................102.3
Remote Control Unit (AR-6482).......................................................................112.4
Tubing..............................................................................................................122.5
Tubing Configurations..........................................................................................122.5.1
Tubing: Main Pump Tubing Set (AR-6410) ..........................................................142.5.2
Tubing: Extension Tubing System (AR-6220) ......................................................152.5.3
Tubing: ReDeuce Pump Tubing (AR-6411)..........................................................152.5.4
Tubing: ReDeuce Patient Tubing (AR-6421)........................................................152.5.5
Tubing: Y-Adapter Tubing (AR-6215)...................................................................152.5.6
Tubing: Outflow Tubing (AR-6430).......................................................................152.5.7
Tubing: Outflow with ReDeuce Patient Tubing (AR-6435)....................................152.5.8
Technical Specifications.....................................................................163.0
Console ...............................................................................................................163.1.1
Foot Pedal...........................................................................................................163.1.2
Remote Control....................................................................................................173.1.3
Setup...................................................................................................184.0
4.1 How to Set Up the Console..............................................................................18
4.2 AC Power Safety Considerations.....................................................................18
4.3 Replacing the Fuses ........................................................................................19
4.4 Electromagnetic Compatibility..........................................................................19
4.5 Basic Setup Procedure for the AR-6480..........................................................19
4.6 Shaver Detection..............................................................................................20
Shaver Detect, Inflow only ...................................................................................204.6.1

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Shaver Detect, Inflow/Outflow..............................................................................214.6.2
Adjusting the Shaver Detect.................................................................................214.6.3
4.7 How to Set Up the Pump Tubing......................................................................22
4.8 How to Set Up the Two-Piece Tubing System .................................................23
4.9 How to Set Up the Outflow Tubing...................................................................23
4.10 How to Change the Language Setting..........................................................24
4.11 How to Test the Power Supply Voltages.......................................................24
4.12 Safe Setup and Performance........................................................................24
Abnormal Operation.............................................................................................244.12.1
Overpressure Sensing.........................................................................................244.12.2
Roller Housing.....................................................................................................254.12.3
Tubing Sensor Coupler........................................................................................254.12.4
Operation............................................................................................265.0
5.1 Initial Pressure Settings....................................................................................26
5.2 How to Operate the AR-6480 in INFLOW ONLY Mode....................................27
5.3 How to Operate the AR-6480 in INFLOW/OUTFLOW Mode............................28
5.4 How to Operate the AR-6480 in LAVAGE Mode..............................................28
5.5 How to Operate the AR-6480 in RINSE Mode .................................................28
5.6 Alternative Suction Pathway (ASP) Mode........................................................29
Cleaning and Disinfecting...................................................................306.0
6.1 Console (AR-6480) ..........................................................................................30
6.2 Remote Control Unit (AR-6482).......................................................................30
6.3 Footswitches Control Unit (AR-6483)...............................................................30
6.4 Tubing..............................................................................................................31
Sterilization .........................................................................................327.0
Transmissible Spongiform Encephalopathy (TSE) ............................338.0
Maintenance .......................................................................................349.0
Technical Support............................................................................3510.0
10.1 How to Display the Software Version............................................................35
10.2 Additional Technical Information...................................................................35
Troubleshooting...............................................................................3611.0
Troubleshooting Interference with Other Devices.........................................3711.1

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LM1-0630-EN_E Page iii of 43
Limited Warranty..............................................................................3812.0
Repair Policy....................................................................................3913.0
Electromagnetic Emissions..............................................................4014.0
Contact Information..........................................................................4315.0
15.1 Compliance Information................................................................................43

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LM1-0630-EN_E Page iv of 43
List of Figures
Figure 1 Front Panel of Console......................................................................................................6
Figure 2 Rear Panel of Console .......................................................................................................7
Figure 3 Foot Pedal Unit (AR-6483).............................................................................................. 10
Figure 4 Remote Control Unit (AR-6482) ..................................................................................... 11
Figure 5 Main Pump Tubing Configuration ................................................................................ 12
Figure 6 ReDeuce Tubing Configuration ..................................................................................... 13
Figure 7 Outflow Tubing Configuration ...................................................................................... 14
List of Tables
Table 1 Front Panel Elements ........................................................................................................6
Table 2 Rear Panel Elements..........................................................................................................7
Table 3 Touch Panel Visual Display Messages AND Iconography............................................ 8
Table 4 Foot Pedal Elements (AR-6483)...................................................................................... 10
Table 5 Remote Control Unit Elements (AR-6482)..................................................................... 11
Table 6 Elements of the Main Pump Tubing Configuration ..................................................... 12
Table 7 Elements of the ReDeuce Tubing Configuration .......................................................... 13
Table 8 Elements of the Outflow Tubing Configuration ........................................................... 14
Table 9 Control Unit (AR-6480) Specifications........................................................................... 16
Table 10 Ambient conditions for operation.................................................................................. 16
Table 11 Ambient conditions for storage (in shipping packaging)............................................. 16
Table 12 Foot Pedal Unit (AR-6483) Specifications...................................................................... 16
Table 13 Remote Control Unit (AR-6482) Specifications............................................................. 17
Table 14 Initial Pressure Settings................................................................................................... 26
Table 15 Common Problems and Remedies................................................................................. 36
Table 16 Guidance and Manufacturer's Declaration - Electromagnetic Emissions................... 40
Table 17 Guidance and Manufacturer's Statement - Electromagnetic Immunity...................... 40
Table 18 Guidance and Manufacturer's Statement - Electromagnetic Immunity...................... 42

Read This First
DualWave Arthroscopy Pump User’s Guide
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1.0 Read This First
Important Safety Information1.1
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 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.
DO NOT—under any conditions or for any reason—remove the
cover of the AR-6480.

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NOTE: Read this User’s Guide thoroughly before operating the device and
save it for future reference.
Users of this device are encouraged to contact their Arthrex representatives if
they require a more comprehensive surgical technique.
Important Symbols and Conventions1.2
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.
W A R N I N G !
The WARNING! is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.
Safety Sign Follow Operating Instructions
Power Standby/On
Attention, Consult Accompanying Document
The CAUTION! symbol identifies methods and procedures that
must be followed to avoid damaging the device or causing it to
malfunction.
NOTE: This identifies information that can simplify the setup and
operation of this device.
Type BF Equipment
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.
Alternating Current

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DualWave Arthroscopy Pump User’s Guide
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Protective Earth [Ground]
Equipotential [Equipment Potential]
WEEE [Waste Electronics and Electrical Equipment] Symbol.
Regarding European Union End-of-Life of Product.
Caution: Federal Law Restricts this device to sale by or on the
order of a Physician.
Fragile
Keep Dry
This Side Up
Temperature Limits for Storage and Transport
[x] Square brackets that enclose a letter, number or lower-case
Roman numeral reference a callout on a line drawing. Section 2.2,
Product Features, includes line drawings of all products
associated with the AR-6480. Each line drawing has its own
callout system to identify important elements of each product.

Read This First
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 4 of 43
Shipping, Unpacking and Warranty Information1.3
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.

Product Description
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 5 of 43
Product Description2.0
Product Description and Intended Use2.1
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.
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. 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 pump tubing options for the AR-6480:
1. Main Pump Tubing Set only.
This tubing, when used alone, must be replaced after each patient.
2. Main Pump Tubing Set and Extension Tubing combination.
The Main Pump Tubing Set can be reused for an entire surgical day,
while the Extension Tubing must be replaced after each patient.
3. ReDeuce™ Pump Tubing and ReDeuce™ Patient Tubing combination.
The ReDeuce™ Pump Tubing can be reused for an entire surgical
day. The ReDeuce™ Patient Tubing must be replaced after each
surgical procedure. The ReDeuce system offers a higher flow rate than
the Main Pump Tubing Set/Extension Tubing combination.
4. Outflow Tubing.
When the Outflow tubing is attached to the AR-6480, the pump
changes from an inflow-only to an inflow and outflow arthroscopy
pump.
The optional Y-Tubing connects up to four irrigation bags and can be used with
all AR-6480 pump tubing options.
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.

Product Description
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LM1-0630-EN_E Page 6 of 43
Product Features2.2
AR-6480 Console: Front View2.2.1
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.
Inflow tubing track
2.
Tubing sensor indicator LED. A steady green LED indicates that
the tubing is connected properly. A flashing red LED indicates
that the tubing is not connected or that it is connected incorrectly
3.
AC mains power switch
4.
Remote control and foot pedal connector
5.
Touch panel visual display (TPVD)
6.
Outflow suction tubing pinch roller
7.
Outflow tubing sensor
8.
Outflow roller assembly
9.
Outflow door
10.
Outflow door locking mechanism
11.
Inflow door locking mechanism
12.
Inflow door
13.
Inflow roller assembly

Product Description
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LM1-0630-EN_E Page 7 of 43
AR-6480 Console: Rear View2.2.2
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.
Input line and fuses
15.
Equipotential ground connector and symbol
16.
Shaver Detect power socket
17.
Shaver or Output Fuse
18.
Access panel (For Arthrex authorized use only)
19.
Date of manufacture and serial number label

Product Description
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AR-6480 Display Messages2.2.3
The console’s Touch Panel Visual Display (TPVD) [5] provides information about
the status of the AR-6480 and the pressure and flow settings in real time. Table 3
describes each message and button when pump is in ready state.
Table 3 Touch Panel Visual 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
[12] or [9] 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 TPVD 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 an
improperly installed tubing set or a split in the
tube from continuous use.
Insufficient measured
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 TPVD displays the pressure reading until
PRESSURE (+) button is pressed. Once pressed,
the displayed pressure reading will change to
the pressure setting. Each subsequent press of
the pressure buttons will increase the pressure
setting in increments of 5.
Pressure set increase,

Product Description
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 9 of 43
Message
Cause
Explanation
-Button
The TPVD displays the pressure reading until
PRESSURE (-) button is pressed. Once pressed,
the displayed pressure reading will change to
the pressure setting. Each subsequent press of
the pressure buttons 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 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 set-up
menu.
User setups displayed.

Product Description
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 10 of 43
Foot Pedal Unit (AR-6483)2.3
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 Foot Pedal Elements (AR-6483).
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 Foot Pedal Unit (AR-6483)
Table 4 Foot Pedal Elements (AR-6483)
i.
LAVAGE. Increases the pressure by a percentage and time
selected by the user.
ii.
RINSE. Increases the outflow rate and pressure by a rate and time
selected by the user. The Pump can also enter Alternative Suction
Pathway (ASP) Mode if pressed while shaver is activated and the
ASP mode is enabled via the Outflow Shaver menu.
i
ii

Product Description
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 11 of 43
Remote Control Unit (AR-6482)2.4
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 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 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.
Lavage. Increases the pressure by a percentage and time selected
by the user.
II.
Pressure Decrease. Decreases target pressure by five mmHg.
III.
Shaver Suction. Cycles through shaver suction settings.
IV.
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) Mode if pressed while shaver is activated and the
ASP mode is enabled via the Outflow Shaver menu.
V.
Pressure Increase. Increases target pressure by five mmHg.
VI.
Run/Stop.
VII.
Lemo Connector. Attaches to the corresponding plug on the front
panel [4] of the AR-6480

Product Description
DualWave Arthroscopy Pump User’s Guide
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Tubing2.5
Tubing Configurations2.5.1
Figure 5, Figure 6 ReDeuce Tubing Configuration, and Figure 7
Outflow Tubing Configuration show the tubing combinations supported
by the AR-6480.
Figure 5 Main Pump Tubing Configuration
Table 6 Elements of the Main Pump Tubing Configuration
Element
Description
Tubing Set
a.
Bag spikes
Y-Adapter Tubing
b.
Tubing clamps
Y-Adapter Tubing
Main Pump Tubing
Extension Tubing
c.
Green connector
Main Pump Tubing
d.
Tubing boot
Main Pump Tubing
e.
Pressure line connector
Main Pump Tubing
f.
Neoprene tube for sensing pressure
fluctuations
Main Pump Tubing
g.
Sensor chamber
Main Pump Tubing
h.
Connector fittings
Main Pump Tubing
Extension Tubing

Product Description
DualWave Arthroscopy Pump User’s Guide
LM1-0630-EN_E Page 13 of 43
Element
Description
Tubing Set
l.
Backflow check valve
Extension Tubing
Figure 6 ReDeuce Tubing Configuration
Table 7 Elements of the ReDeuce Tubing Configuration
Element
Description
Tubing Set
a.
Bag spikes
Y-Adapter Tubing
b.
Tubing clamps
Y-Adapter Tubing
ReDeuce Pump Tubing
ReDeuce Patient Tubing
c.
Green connector
ReDeuce Pump Tubing
d.
Tubing boot
ReDeuce Pump Tubing
e.
Pressure line connector
ReDeuce Pump Tubing
f.
Neoprene tube for sensing pressure
fluctuations
ReDeuce Pump Tubing
g.
Sensor chamber
ReDeuce Pump Tubing
k.
High flow, dual lumen connectors
ReDeuce Pump Tubing
ReDeuce Patient Tubing
l.
Backflow check valve
ReDeuce Patient Tubing

Product Description
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Figure 7 Outflow Tubing Configuration (AR-6430)
Table 8 Elements of the Outflow Tubing Configuration
Element
Description
Tubing Set
A.
Tubing clamp
Outflow
B.
Shaver attachment
Outflow
C.
Cannula attachment
Outflow
D.
Waste egress
Outflow
E.
Outflow Fixture
Outflow
F.
Tubing loop for Outflow roller
Outflow
G.
Paper retaining strap
Outflow
Tubing: Main Pump Tubing Set (AR-6410)2.5.2
The Main Pump Tubing Set offers inflow and pressure measurement tubing. If
used alone, the tubing must be completely discarded following each surgical
procedure. The Main Pump Tubing is 13 feet (4.0 meters) in length.
NOTE: This User’s Guide assumes that either the Main Pump Tubing is used
alone or in combination with the Extension Tubing, described below.