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NT060US
Rev A - 2021-06 2027767-1
• INSPECT instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments. This may be done visually
under magnification or with a high voltage insulation testing device. Insulation failures may result in burns or other injuries to the patient or operator. For
reusable instruments, visual inspection alone may not be sufficient to ensure the insulation is intact and the instrument is safe to use.
• Connect the device only to the monopolar receptacle of the generator. Improper connection may result in inadvertent activation or other potentially hazardous
conditions. Connect adaptors and accessories to the electrosurgical unit only when the energy is off. Failure to do so may result in an injury or electrical shock
to the patient or operating room personnel.
• The device requires the use of monopolar electrosurgical generators that monitor the current of the return electrode.
• Apply the patient return electrode according to the recommendations of the generator manufacturer.
• The entire surface of the neutral electrode should be securely connected to the patient’s body and as close as possible to the surgical field.
• The patient should not be in contact with grounded metal parts or parts having an appreciable capacity with respect to the ground (for example operating table,
supports, etc.). Antistatic wrapping is recommended in this case.
• Skin to skin contact (for example between the patient’s arms and body) must be avoided, for example by separation with dry gauze.
• Loss of safe contact between the neutral electrode and the patient will not result in an alarm as the devices are not equipped with a (CQM) contact quality
monitor.
• Prior to increasing the intensity, check the adherence of the neutral electrode and its connections. Apparent low output or failure of the device to function
correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections.
• Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure; Integra instruments have not been validated to withstand the chemical and
thermal exposure recommended to eradicate prions.
PRECAUTIONS
• Do not use abrasive cleaning products such as hard brushes, etc.
• Make a visual inspection of the instrument and the cable to ensure that the electrical insulation is in good condition.
• Extreme care must be taken when handling and cleaning instruments with sharp points or edges.
• The use of trocars made entirely of plastic or metal is recommended with electrosurgical devices in order to avoid thermal injuries in the surgical access zones.
• We recommend you to use MicroFrance
®
trocars.
• Delicate instruments should be handled with extreme care to prevent damage.
• Limit coagulation / cutting with scissors as much as possible to preserve the blades.
• The intensity should be set as low as is necessary to achieve the desired effect to reduce the risk of patient burns at high voltages.
• Keep the active electrodes clean. Build-up of eschar may reduce the instrument’s effectiveness. Do not activate the instrument while cleaning. Injury to
operating room personnel may result.
ADVERSE EVENTS
• Localized burns to the patient or physician may result from electrical current carried through conductive objects (such as trocar cannulas). Electrical current
may be generated in conductive objects by direct contact with the active electrode, or by the active accessory (electrode or cable) being in close proximity to
the conductive object.
INSTRUCTION FOR USE
• The instrument is intended to be used with Monopolar HF electrosurgical generators and cables compliant with standards IEC60601-1, IEC60601-1-2, and
IEC60601-2-2 to ensure safety and electromagnetic compatibility. Electrosurgical monopolar output frequency should be in the range between 240 kHz – 562
kHz. MicroFrance Instruments has been tested compliant to IEC60601-1-2 standard using a generator as recommended above. Please refer to manufacturer’s
generator manual for instructions for use, technical description, and equipment setup information to comply with requirements for electromagnetic compatibility.
• Reusable instruments must be cleaned and sterilized before the first use and before every new use.
• It is the responsibility of the surgical team to select the appropriate instruments for each use.
• Ensure the electrosurgical generator is in off or standby mode, and connect the device cable to the monopolar receptacle of the electrosurgical generator only,
ensuring the connector pins are fully seated in the generator receptacle.
• Position electrosurgical cables to avoid contact with the patient, user or other cables.
• Begin procedures at the lowest possible electrosurgical power setting. Slowly increase power until the desired coagulation effect is achieved. This practice
reduces the possibility of the following problems: a) capacitive coupling b) damage to insulation c) increased risk of patient burns at high voltages.
• If the output power appears weak at normal functional settings, check connections, cables, the generator and the instrument before selecting higher output
power.
• Carefully insert and remove the instruments from the trocars. Close the jaws of the instruments when passing through trocars.
• For instruments that incorporate suction, a stylet is recommended clearing and/or removing clogged tissue.
• Avoid prolonged activation. Short, multiple activations prevent surrounding tissue from heating up.
REPROCESSING INSTRUCTIONS for Reusable Instruments (PER ISO17664)
When applying dry times to Integra
®
instrument trays and their accessories, dry times outside the standard healthcare prevacuum parameters may be required.
The current recommended dry times may range from a standard 15 minutes to an extended time of 40 minutes. This is especially important for polymer-based
(plastic) instrument trays. The user should have adequate means to verify drying time, such as visual inspection.
Warnings/
Precautions
To prevent stains, use distilled or demineralized water, and uses a neutral detergent to reprocess these instruments. Do not cold soak
in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilize, as damage to the instrument finish may occur.
INSTRUCTIONS
1) Bringing into
service of a new
instrument
This product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse. The protection / silicone caps
used during shipment must be removed before cleaning and sterilization procedures.
2) Preparation at the
point of use
It is recommended that instruments be reprocessed as soon as is practical following use. Rinse instrument immediately after use in
distilled or demineralized water. Keep instrument moist (for example, cover with a wet drape or saturate with tap water – do not use
saline) after use and prior to decontamination, cleaning and sterilization to ensure adequate cleaning. Instruments with cleaning ports
and/or suction tubes shall be flushed with neutral pH enzymatic detergent, followed by a tap water rinse.
3) Preparation before
cleaning
Fully disassemble modular designed instrument for effective cleaning. Remove any cap covering the cleaning port, if applicable. For
instruments with lumens and instruments equipped with cleaning ports, inject cleaning solution through the instrument with an irrigation
syringe. When cleaning suction tubes with holes to control suction, place gloved finger over the control hole to flush through the tube.
Open any articulated instruments before positioning in the soaking solution. Place instruments so they do not touch each other. Note:
Flushing in running water is essential between decontamination and cleaning to prevent any risk of reaction between the two solutions.
