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ENGLISH
FMS
®
5-Way Foot Pedal
DESCRIPTION
The FMS 5-way Foot Pedal controls shaver and suction functions when used with the FMS VUE™ or NEXTRA™ Fluid
Management Systems.
INTENDED USE
The FMS 5-Way Foot Pedal is intended for use with the FMS VUE or NEXTRA Fluid Management and Tissue Debridement Systems in
a surgical setting by personnel trained in arthroscopy.
INDICATION FOR USE
The 5-Way Foot Pedal is an accessory to the FMS VUE and NEXTRA Fluid Management and Tissue Debridement Systems.
The FMS VUE and NEXTRA Fluid Management and Tissue Debridement Systems which provide controlled fluid distention and suction,
controlled cutting, burring, shaving and abrading of bone and tissue for arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist
and hip joints.
CONTRAINDICATION
Do not use the 5-Way Foot Pedal with systems other than the FMS VUE or NEXTRA Fluid Management Systems.
WARNINGS
•
This equipment may be operated only by arthroscopic surgeons. The surgeon using this device must be trained in arthroscopic
surgical procedures, be aware of the risks associated with those procedures, and have current knowledge of technological advances in
surgical products and techniques.
•
Prior to use, check the system components for damage. Check the cable integrity carefully. If there are signs of damage, do not use.
•
Failure to follow all applicable instructions may result in serious surgical consequences to the patient.
•
Factory settings should be used only as guidelines. The surgeon is responsible for settings pertaining to his surgical procedure.
•
Do not wrap Foot pedal power cables around metal objects. Wrapping cables around metal objects may induce currents that could lead
to electric shock, fire and/or injury to patient or surgical personnel.
•
This device has been tested and found in compliance with limits of medical devices according IEC 60601-1-2 standard. These limits
are designed to provide reasonable protection in a typical medical installation, against harmful interference when devices are located
in close proximity. If the pump is causing harmful interference with other devices, turn the main power off, then on again to determine
if it is causing the interference, relocate the system or separate it from other devices. If you cannot resolve the problem contact DePuy
Customer Service at 1-800-382-4682. In the European Union, contact your local affiliate.
•
Disconnect the device from the pump when cleaning or inspecting.
Summary of Contents for FMS 283573
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