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Valleylab FT10 Energy Platform User’s Guide
Warnings and Precautions for Monopolar Procedures
Warnings and Precautions for Patient Return Electrodes
Warning
It is not possible to foresee what combination of current and duty cycle may be safely used in every
situation—for example, when higher currents and/or longer duty cycles are used on procedures
such as tissue lesioning, tissue ablation, tissue vaporization; and procedures where conductive fluid
is introduced into the surgical site. Under these conditions a greater risk may exist that the heating
under a fully applied return electrode may be high enough to injure the patient.
When using a Covidien energy platform or a patient return electrode during these types of surgical
procedures, the user should seek written guidance in the form of detailed user instructions from
the manufacturer of the active accessory regarding the currents and duty cycles that can be
expected. In some instances, the application of additional patient return electrodes may help
mitigate the increased risk.
Do not attempt to use patient return electrodes that disable the Return Electrode Monitoring (REM)
system. The VLFT10GEN REM system will function correctly only with contact quality monitoring
(CQM) split-style patient return electrodes. Other patient-return-electrode products may cause
patient injury or product damage.
The safe use of monopolar electrosurgery requires proper placement of the patient return
electrode. To avoid electrosurgical burns beneath the patient return electrode, follow all directions
provided with the product.
Do not cut a patient return electrode to reduce its size. Patient burns due to high current density
may result.
To avoid patient burns, ensure that the patient return electrode makes firm and complete contact
with the skin. Always check the patient return electrode periodically, after the patient is
repositioned, and during procedures involving long periods of activation.
Use of duty cycles greater than 25% (10 seconds active followed by 30 seconds inactive) will
increase the risk that heat build-up under a return electrode may be high enough to injure the
patient. Do not continuously activate for longer than one minute.
Apparent low-power output at the normal operating settings may indicate faulty application of the
return electrode. Verify the return electrode is correctly placed and attached to the patient as
described in the electrode’s instructions for use. Verify the connection between the electrode and
the generator.
Use of a non-REM return electrode while in DEMO mode does not monitor the quality of pad
contact with the patient. No warning will be issued from the generator when a non-REM return
electrode’s pad-to-patient contact degrades when in DEMO mode.
Precaution
Covidien REM Polyhesive patient return electrodes are recommended for use with the FT10. Return
electrodes from other manufacturers may not provide proper impedance to work correctly with the
energy platform.
