Operating Warnings - Johnson & Johnson DePuy Synthes FMS VUE II Manuel De L'opérateur

2.1.2 Operating 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 .
• While using the tubing with one-way valve, if additional joint pressure is created by the surgeon
during joint manipulation, the pressure displayed at the pump will not reflect the pressure
change, which could possibly lead to extravasation .
• Do not use the pump adjacent to or stacked with other electrical equipment . If adjacent or
stacked use is necessary, observe both the equipment and pump to verify normal operation in the
configuration in which it will be used .
• Portable and mobile RF communications equipment can affect Medical Electrical Equipment .
• Do not use in the presence of a flammable anesthetic mixture with air, or in the presence of a
flammable anesthetic mixture with oxygen or nitrous oxide .
• Factory settings should only be used as guidelines . The surgeon is responsible for settings
pertaining to the surgical procedure .
• Failure to follow all applicable instructions may result in serious surgical consequences to
the patient .
• Use the FMS CONNECT Interface Cable to connect handpieces other than those
manufactured by DePuy Synthes (Contact your DePuy Synthes representative for availability) .
For instructions and supported handpieces, refer to FMS CONNECT Cable for FMS VUE II
Instructions for Use . (P/N: IFU-111105) .
• Any modifications to the system must be authorized by DePuy Synthes . Modifying the device
in a manner other than specified by DePuy Synthes may result in injury . Contact Customer
Service at 1-800-382-4682 for service requests . Outside the United States, contact your local
affiliate .
• The FMS VUE II pump is equipped with a terminal for the connection of a Potential
Equalization Connector as required by Electrical Safety Standard IEC 60601-1 . To install the
connector, connect one end to the terminal on the back of the pump . Attach the other end to
the bus bar of the electrical installation . The Potential Equalization Connector is provided to
prevent electric shock hazards by maintaining a constant potential (voltage) to all exposed
metal parts so a person cannot simultaneously make contact with two different potentials . Use
of the potential equalization connector should be determined by the facility where it is installed
based on the design of the electrical distribution system .
• This device has been tested and found in compliance with limits of medical devices according
to IEC 60601-1-2 standard . These limits are designed to provide resonable protection in a
typical medical installation, against harmful interference when devices are located in close
proximity . If the pump is causing harmful interference, turn the main power off, then on again to
determine the cause of 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 .
Outside the United States, contact your local affiliate .
• Accessories labeled "REUSABLE" must be processed only according to the recommended
procedures . Refer to the applicable Instructions for Use .
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