Intended Use / Indications For Use; Product Description - ConMed SureFit 410-2000 Instrucciones De Uso

ENGLISH/INSTRUCTIONS FOR USE
SUREFIT™
DISPERSIVE ELECTRODES
Read and become familiar with all instructions and cautions before using this product.

INTENDED USE / INDICATIONS FOR USE:

SureFit Dual Dispersive electrodes (also referred to as neutral electrodes or pads) are designed for use with only those electrosurgical generators
equipped with Contact Quality Monitoring (CQM) systems during electrosurgery and provides a path for RF energy produced at the active electrode to
return to the generator. The SureFit Dual Dispersive electrode is for use with all patient populations providing there is sufficient surface area to ensure
full contact of the electrode with the patient's skin.

PRODUCT DESCRIPTION:

CONMED SureFit Dual Dispersive electrodes are intended to be compatible with Electrosurgical generators that include a Contact Quality Monitoring
System (CQM) that operates with a maximum CQM impedance limit of 150 ohms, such as, but not limited to the CONMED Automatic Return Monitor
system (ARM™).
SureFit Dual Dispersive electrodes are for use on patients weighing more than 2.2 kg. provided there is sufficient surface area to ensure full contact of
the pad with the patient's skin.
CONMED SureFit Dual Dispersive electrodes conform to the requirements of ANSI/AAMI/IEC 60601-2-2: 2009; § 201.15.101 for Neutral Electrodes,
and are compatible with High Frequency Electrosurgical Generators (ESU) that conform to the requirements of the ANSI/AAMI/IEC 60601-2-2: 2009
standard for Electrosurgical generators.
These devices should only be used by, or under the supervision of, a trained physician. They are to be used in hospitals and surgical centers where
electrosurgical procedures using RF energies are performed.
The information provided here applies to the following CONMED SureFit Dispersive electrodes:
SureFit Dual Foil electrodes: 410-2000, 410-2100, 410-2200, 410-2400
WARNINGS:
• Some equipment and/or techniques fall outside the intended use of standard Electrosurgery dispersive electrodes, such as application of
high current, long activation times, or use of conductive fluid (e.g. tissue ablation, joint ablation, etc.). In these high current procedures, there is a
risk that excess heat may build up in standard dispersive electrodes which may result in patient injury or burns. CONMED SureFit Dual Dispersive
electrodes have not been tested for use during high current procedures and are not recommended for non-standard electrosurgical applications.
Consult the generator and accessory manuals for recommendations provided by the manufacturer.
• SureFit Dual Dispersive electrodes are not recommended for use in High Current Procedures where the activation time and current exceed 30 A
in any 60 second period.
• Use of SureFit Dual Dispersive electrodes on adults in high current procedures exceeding 700 mA and maximum cumulative activation time of 60
seconds in any 120 second period can result in electrosurgical burns or poor electrosurgical performance.
• Use of SureFit Dual Dispersive electrodes on pediatric patients in high current procedures exceeding 500 mA and maximum cumulative activation
time of 60 seconds in any 120 second period can result in electrosurgical burns or poor electrosurgical performance.
• Contact your organization's Biomedical Engineering department and/or the electrosurgical generator manufacturer directly for questions pertaining
to any technical specifications or requirement listed here.
• Always use the lowest power settings to achieve the desired surgical effect.
• Do not modify the pad. Modification may result in patient or operator harm.
• SureFit Dual Dispersive electrodes are for use on patients weighing more than 2.2 kg provided there is sufficient surface area to ensure full contact
of the pad with the patient's skin. Failure to achieve good skin contact by the entire adhesive surface may result in electrosurgical burns or poor
electrosurgical performance.
• Do not coil dispersive electrode cable or allow the cable to overlie other electrosurgical monitoring cables or equipment, as the unintended transfer
of potentially harmful RF energy may result.
• Conductive parts of the pad and associated connectors should not contact any other conductive parts including earth, as this contact may increase
the risk of harm to the patient or operator.
• Difficulty in achieving cutting or coagulating energies requires evaluation. Stop. Do not proceed or increase power settings until you have checked
all components of the electrosurgical circuit including the active electrode and its cable, the patient pad adherence and integrity, and the electrical
generator and its connectors. Indiscriminate power increase may result in patient burns.
CAUTION:
• Heat applied by thermal blankets or other sources are cumulative with heat produced at the pad. Choice of an application site removed from
other heat sources reduces the risk of patient injury.
• Always use the lowest power settings to achieve the desired surgical effect.
• Do not use a needle monitoring ECG electrode with dispersive electrodes.
• Avoid skin to skin contact when positioning patient, using dry gauze where necessary.
• When wrapping a pad around a limb, the pad must not touch or overlap itself.
• Additional pad gel is not required and should not be used.
• If patient is repositioned, re-inspect the pad and all connections.
• Do not re-use or re-locate the pad after initial application.
• Immediately wipe up any spilled fluids in area of the pad. Keep application site dry.
• Avoid applying pressure to the pad through use of straps, tie downs, tape, etc.
• Rapid removal of the pad may cause skin irritation or damage.
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