Product Description
DualWave Arthroscopy Pump User’s Guide
DFU-0212 Rev. 1 Page 7 of 54
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Product Description
2.1 Product Description and Intended Use
The Arthrex AR-6480 DualWave Arthroscopy Pump is a system that maintains
constant, non-pulsed control of intra-articular rinsing and distention pressure
throughout all phases of an arthroscopic surgical procedure. The AR-6480 is
intended to provide continuous pulse-free flow that reacts immediately to changes
in the intra-articular pressure so that joint distention can be sustained even under
high shaver extraction volumes or secondary outflow.
WARNING!
All fluid inflow devices, including gravity assist, may cause fluid extravasations into
the surrounding tissues. This extravasation may be mild, moderate, or severe. In
severe cases, the resulting edema may result in a serious adverse patient event
which may include compartment syndrome, nerve compromise, or death.
Undiagnosed capsular defects will exacerbate fluid extravasation conditions.
When utilizing any fluid management device, the patient (extremity and
surrounding area) must be monitored closely by the surgical team for signs of
excess fluid buildup. Fluid usage volumes should be monitored and compared to
similar surgical procedures. With all arthroscopy pumps, correct setup and proper
user operation is required. Always select the lowest possible pressures in order to
achieve the required intra-articular distention. All alarms or alerts must be
acknowledged and the appropriate troubleshooting procedure followed.
WARNING!
FAILURE TO FOLLOW THE SETUP INSTRUCTIONS AND/OR CONTINUING TO
USE THE PUMP WITHOUT RESOLVING AN ALARM CONDITION COULD
RESULT IN A SERIOUS PATIENT ADVERSE EVENT.
Failure to adhere to the setup instructions and use of Arthrex certified tubing may
result in inaccurate pressure sensing and monitoring by the device. It is imperative
that the user is aware that patient safety may be compromised when an alarm on
the pump is ignored or silenced incorrectly. NEVER ignore or silence alarms.
Follow the appropriate troubleshooting procedures and carefully monitor the
patient. Only Arthrex certified tubing must be used.
WARNING!
This device is only for use in normal arthroscopic procedures as described in the
User’s Guide, under the supervision of a trained and licensed physician. This
device should not be used by untrained personnel or used for indications other
than those described in this User’s Guide.
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