430-11902-02 Rev N
The sparking of heating associated with electrosurgery can provide an
ignition source.
Use ESU with caution in the presence of internal and external
devices such as pacemakers or pulse generators. Interference
produced by the use of electrosurgical devices can cause
pacemakers to enter an asynchronous mode or can block pacemaker
effect entirely.
If patient has an implantable cardioverter defibrillator (ICD), contact the
ICD manufacturer for instructions before performing procedure.
Do not turn unit volume down to an inaudible level. This may prevent the
surgical team from being aware of alarm and alert messages.
For RF ablation procedures where the high frequency current could flow
thorough parts of the body having a relatively small cross-sectional area,
the use of bipolar techniques may be desirable in order to avoid
unwanted tissue damage.
Do not position the unit in a way that prevents cord removal. The cord
acts as an emergency power cut-off.
The equipotential stud should only be connected to IEC 60601-1
compliant equipment to avoid excessive leakage currents.
PRECAUTIONS:
Observe these precautions before using the System:
Do not attempt to operate the System before thoroughly reading this
Operator's Manual. It is important that the equipment's operating
instructions be read, understood and followed. For future reference,
retain this Manual in a convenient, readily accessible place.
When used with accessories that require fluid cooling, the ESU generator
should be set up so that it is not in proximity to the fluid cooling
subsystem. THE ESU IS NOT WATERPROOF.
The operator should keep the set temperature and power limit as low as
possible to achieve the desired end effect. This avoids excessive thermal
damage to tissue, or collateral damage to adjacent tissue not intended for
coagulation.
Read and follow the Disposable Indifferent (Dispersive) Pad (DIP)
Electrode manufacturer's instructions for use. Use only DIP Electrodes
which meet or exceed ANSI/AAMI IEC 60601 requirements.
Placement of DIP electrodes on thighs can be associated with higher
impedances, which can result in automatic RF power shut-off.
The ESU is capable of delivering significant electrical power. Patient or
operator injury can result from improper operation of the System. During
power delivery, the patient should not be allowed to come in contact with
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