Directed Electronics 1500X User's Guide Page 6

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AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual
160-103990 Rev 03 Page 4
3. WARNINGS AND PRECAUTIONS
3.1 General Warnings and Precautions
Read all instructions for use for the RITA
System prior to its use. Safe and effective
electrosurgery is dependent not only on equipment design but also on factors under
control of the operator. It is important that the instructions supplied with this
equipment be read, understood, and followed in order to enhance safety and
effectiveness.
For use only by qualified medical personnel trained in the safe use of electrosurgery
and in the proper use of the RITA
System.
3.2 Environmental and EMI Warnings and Precautions
In the case of a pacemaker, a theoretical hazard exists because interference with the
action of the pacemaker may occur, and the pacemaker may become damaged or
may reset to its factory default. Questions should be directed to the attending
Cardiologist, or to the pacemaker manufacturer, and it is recommended that the
patient see a cardiologist after the procedure to verify functionality of the pacemaker.
Any monitoring electrodes should be placed as far as possible from the RITA
Device and should incorporate high-frequency current limiting devices.
Do not use flammable anesthetics, gases, or liquids while the RF Generator is in
use. The risk of igniting flammable gases or other materials is inherent in
electrosurgery and cannot be eliminated by device design. Precautions must be
taken to avoid contact of flammable materials and substances with electrosurgical
electrodes, whether they are in the form of an anesthetic or skin preparation agent,
or produced by natural processes within body cavities, or originate in surgical
drapes, tracheal tubes or other materials.
Interference produced by operation of high-frequency surgical equipment may
adversely affect the operation of other electronic medical equipment such as
monitors and imaging systems. This can be minimized or resolved by rearranging
monitoring device cables so they do not overlap the RITA
System cables.
Electric shock hazard. Do not saturate the RF Generator with liquids. Do not allow
liquids to run inside the unit. Do not immerse the RF Generator in water. Shut off
the RF Generator and disconnect power before cleaning. Do not sterilize the RF
Generator.
3.3 Warnings and Precautions during Electrosurgical Device Use
Precautions during ablation near organ surface or near vasculature – Due to the non-
homogenous conduction and convection of heat in this type of anatomy, shapes of
ablations performed on tissue that is near the organ surface or near vasculature may
not be spherical. Careful planning should be done for targets that require ablation in
these locations. Any application or procedure that alters tissue perfusion and affects
temperature elevation should be monitored carefully.
Any application or procedure that alters tissue perfusion and affects temperature
elevation should be monitored carefully. If a Bair Hugger® or another warming
device is used, turn it off prior to the ablation as this may constrict blood flow and
elevate the temperature. If leg/circulation compressors are used, use calf-length
devices, so that there is no overlap with the ThermoPads.
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