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NT060US
Rev A - 2021-06 2027767-1
EN English / Product Information and Instructions
DESCRIPTION OF THE DEVICES
Monopolar electrosurgical instruments are available in different configurations to be used in laparoscopic and open surgery as indicated by surgical techniques.
Electrical insulation is applied to selected portions of the instrument and a connector is provided to attach the instrument to a variety of currently available
monopolar electrosurgical generators. These devices are intended to be used by qualified physicians and operating room personnel familiar with high frequency
current and who have been properly and correctly trained in the surgical techniques that must be used. Physicians should seek relevant pre-clinical education
before attempting new surgical procedures, especially those in insufflated cavities.
MATERIALS
The instruments are fabricated of one of the following biocompatible materials: glass, ceramic, titanium nitride, stainless steel, tungsten, thermoset polymers
(including silicone), thermoplastic polymers, sterling silver or chromed brass.
INTENDED USE
Monopolar electrosurgical instruments are indicated for laparoscopic and non-laparoscopic procedures where the physician determines that high-frequency
electrical current is appropriate to remove tissue and/or control bleeding.
INDICATIONS FOR USE/INTENDED PURPOSE
The electrosurgical instruments are intended to remove tissue and/or control bleeding.
CONTRAINDICATIONS
None known.
SAFETY
• Before each use, check the outer surface of the parts introduced into the patient to verify that there is no rough surface, no sharp edge or undesirable
protrusion which may cause a safety hazard.
• Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
WARNINGS
• The maximal assigned output voltage that can be applied to a monopolar high-frequency electrosurgical accessory is 1355 Vrms [1958 Vpeak] except
for special indications etched on the instrument and/or on a specific insert. Such peak voltage can be achieved with certain modes of functioning of some
electrosurgical generators. Please check with the manufacturer of the electrosurgical generator and/or refer to the technical documentation supplied by the
manufacturer of the electrosurgical generator.
• Do not use these instruments for purposes other than those for which they are intended.
• Do not bend, disassemble or force an instrument; breakage or failure of the instrument could occur, resulting in possible harm to the patient or user.
• Use appropriate personal protection equipment when handling contaminated instruments.
• Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume and aerosols), protective eyewear,
filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Monopolar Standard Cables recommended are MicroFrance Part numbers as follows:
MicroFrance Part Number
CP391
CP391-3
CP391-4
CP391E
CP391M
CP391V
Length (mm)
1800 +/- 80
3000 +/- 80
4500 +/- 100
3500 +/- 80
• For devices that incorporate suction, do not extend suction tube while monopolar energy is applied, in order to avoid accidental burns.
• DO NOT activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling with other surgical equipment.
• DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N
2
O) and oxygen) or in close proximity to volatile solvents
(such as ether or alcohol), as explosion may occur. Fires can occur if this type of instrument is used in an environment rich in oxidizing gases such as oxygen
or nitrous oxide (N
2
O), including intubation tubes (burns of the respiratory pathways) and the concentrations of oxygen collecting under surgical drapes. Review
security procedures before using this instrument.
• Non-flammable agents should be used for cleaning and disinfection wherever possible. Flammable agents used for cleaning or disinfecting or as solvents of
adhesives should be allowed to evaporate before the application of HF surgery. There is a risk of pooling of flammable solutions under the patient or in body
depressions such as the umbilicus or in body cavities such as the vagina. ASPIRATE fluid from the area before activating the instrument. Conductive fluids
(e.g., blood or saline) in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may
cause unintended burns to the patient. Attention should be called to the danger of ignition of endogenous gases.
• DO NOT place instruments near or in contact with flammable materials (such as gauze or surgical drapes). Instruments that are activated or hot from use may
cause a fire. Some materials, for example cotton or gauze, when saturated with oxygen, may be ignited by sparks produced in normal use.
• Do not place the instrument on the patient when it is not being used. Place the instrument in an insulated support or on a clean, dry surface, very visible and
non-conductive, so as to avoid accidental electrical injuries.
• When not using instruments, place them in a clean, dry, highly visible area not in contact with the patient. Inadvertent contact with the patient may result in
burns.
• Do not try to modify the instrument. Do not try to repair the electrical insulation.
• Do not “buzz” the instrument during the surgical procedure to reduce the risk of burning the patient or the physician.
• To avoid lesions at other sites, only activate the generator when the surgical field and the distal extremity of the forceps are sufficiently visible.
• Use extreme care when coagulating long, thin tissue, such as adhesions. These tissues can carry electrical current to an unseen or remote location. In this
case, the use of bipolar techniques can be desirable so as to avoid tissue damage.
• Trocar canulas, if used with the device, should be inspected for sharp edges that may damage the electrical insulation of the instrument. When using a trocar
canula, the working end of the device must pass entirely through the trocar canula for the device to function properly and effectively.
• DO NOT USE with hybrid trocar systems, i.e., a combination of metal and plastic, when using monopolar active components. This may result in alternate site
burns due to capacitive coupling. Use only all-metal or all-plastic trocar systems.
• The pathways of the current through conductive elements like metal instruments and endoscopes can cause local burns to the patient, the physician or another
member of the care team. Contacting conductive elements with the active cautery area may cause undesired tissue heating and burns.
• The surface of the active electrode may remain hot enough to cause burns after the HF current is deactivated.
• Alternate site injuries may occur at an electromyography (EMG) needle electrodes monitoring site.
• Electrosurgical devices may cause electromagnetic interference with other operating room devices.
• To avoid alternate site burns, ensure hinges, handles and proximal un-insulated portions of the electrosurgical instruments do not inadvertently contact patient.
• DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A
possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged. In case of doubt, advice or
approval from the manufacturer of the active device should be obtained.
• Extreme care should be taken when handling instruments with a dielectric coating. Damage to the dielectric coating may result in patient / user injury.
• To ensure proper functioning of dismantable devices and devices with accessories, check the assembly and the functionality of all elements of the device
before use.
