Read This First
DualWave Arthroscopy Pump
User’s Guide
LM1-0630-EN_E
Page 1 of 43
1.0
Read This First
Important Safety Information
1.1
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.
Содержание AR-6480
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