Indications And Contraindications; Warnings, Precautions, And Adverse Reactions - estech COBRA 604-4810B Instrucciones De Uso

430-11902-02 Rev N

2. INDICATIONS AND CONTRAINDICATIONS

Indications for Use
The Estech ESU is intended to supply controlled RF energy to the
electrodes of Estech RF Ablation Probes. Please see the specific
Probe's Instructions for Use for the Probe's intended use.
Contraindications
•
This system is contraindicated for tissue coagulation in any situation
where, in the physician's opinion, excessive thermal damage to
tissue, or collateral damage to adjacent tissue not intended for
coagulation may result.
•
Local or systemic infection

3. WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS

WARNINGS:
Before operating the System, read the following warnings carefully:
This equipment is for use only by trained, licensed physicians.
The voltage selector must be set to the same setting as the power entry
module.
Grounding reliability can only be achieved when the power supply cord is
connected to a receptacle marked Hospital Only or Hospital Grade.
Connect the power cord to a properly polarized and grounded power
source with the frequency and voltage characteristics that match those
on the back panel of the unit.
Always turn off and unplug the unit before cleaning to prevent electric
shock hazard.
For patient safety use the unit only if the self-test has been completed as
described.
Only use the ESU with Estech ablation probes. See
for available Estech ablation probes.
Do not use Estech ablation probes or cables that are damaged in any
way.
Do not use the ESU in the presence of fire and explosion hazards in the
operating room:
•
Flammable substances
•
Flammable gases
•
Oxygen enriched atmospheres
•
Oxidizing agents
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