Arthrex DualWave User Manual

General Warnings and Safety Notices - Read This First
DualWave Arthroscopy Pump User’s Guide
DFU-0212 Rev. 1 Page 1 of 54
1.0 General Warnings and Safety Notices - Read This First
It is imperative that the symbols and conventions listed below be clearly understood. The
DualWave Arthroscopy Pump User’s Guide identifies critical, important, and useful
information using these symbols and conventions.
1.1 Important Safety Conventions
Users of this device are encouraged to contact their Arthrex representative if they
require a more comprehensive surgical technique.
WARNING!
WARNING! is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.
1. All fluid inflow devices, including gravity assist, may cause fluid extravasations
into the surrounding tissues. This extravasation may be mild, moderate or
severe. In severe cases, the resulting edema may result in a serious adverse
patient event which may include compartment syndrome, nerve compromise,
or death. Undiagnosed capsular defects will exacerbate fluid extravasation
conditions.
2. Failure to follow the setup instructions and/or continuing to use the pump
without resolving an alarm condition could result in a serious patient adverse
event.
3. Failure to adhere to the setup instructions and use of Arthrex certified tubing
may result in inaccurate pressure sensing and monitoring by the device. It is
imperative that the user is aware that patient safety may be compromised when
an alarm on the pump is ignored or silenced incorrectly. NEVER ignore or
silence alarms. Follow appropriate troubleshooting procedures and carefully
monitor the patient. Only Arthrex certified tubing must be used
4. This device is only for use in normal arthroscopic procedures as described in
the User’s Guide, under the supervision of a trained and licensed physician.
This device should not be used by untrained personnel or used for indications
other than those described in this User’s Guide.
5. When utilizing any fluid management device, the patient (extremity and
surrounding area) must be monitored closely by the surgical team for signs of
excess fluid buildup. Fluid usage volumes should be monitored and compared
to similar surgical procedures. With all arthroscopy pumps, correct setup and
proper user operation is required. Always select the lowest possible pressures
in order to achieve the required intra-articular distention. All alarms or alerts
must be acknowledged and the appropriate troubleshooting procedure
followed.
6. No modification of the console (AR-6480) or accessories is allowed.

Arthrex DualWave Specifications

General

Brand	Arthrex
Model	DualWave
Category	Medical Equipment
Language	English