Electrosurgical dissectors

PlasmaBlade™ X dissection device

<p>The PlasmaBlade™ X device uses a 99.5%-insulated electrode to cut and coagulate soft tissue with radiofrequency energy during surgical procedures.</p>

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Indications, Safety, and WarningsIndicationsThe Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.ContraindicationsThe PlasmaBlade™ X should not be used on small appendages or body parts, as in circumcision.Adverse eventsAs a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.Warnings

Observe fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking and heating.

Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen. Do not activate the device until vapors from alcohol-based skin prepping agents have dissipated. Naturally occurring gases that accumulate in body cavities can also be an ignition source.

Do not touch the electrode tip of the PlasmaBlade™ X device while power is being applied as this may result in user injury.

Do not contact metal objects and instruments with the PlasmaBlade™ X device while power is being applied as unintended tissue damage and electrode tip damage could occur.

Activation of the handpiece when not in contact with target tissue may cause capacitive coupling.

Do not allow patient contact with grounded metal objects, as such contact may result in patient or user injury.

Activation of the handpiece simultaneously while aspirating fluid may alter the path of electrical energy away from target tissue.

Activation of the PlasmaBlade™ X device outside the field of view could cause patient injury.

Inadvertent patient contact may result in burns. When not in use, place the device in a dry and nonconductive area away from the patient.

Ensure that only the active tip of the device is in contact with the patient during use.

Monopolar devices require a Patient Return Electrode. Compatible generator contact quality monitoring (CQM) systems will only function properly with split-style patient return electrodes. Other patient return electrode products may not identify loss of safe contact between the return electrode and the patient, thereby failing to provide auditory or visual alarms and causing patient injury or product damage. Refer to the manufacturer’s instructions for application site and placement procedures when applying the Patient Return Electrode. Do not rely entirely on the impedance sensing feature as it can be affected by a damaged (shorted) Patient Return Electrode. It is recommended that the operator verify appropriate placement and contact of the Patient Return Electrode. Inadequate contact of the Patient Return Electrode may result in patient alternate site burns or injury. Refer to the selected generator's Operator's Manual for compatible Patient Return Electrodes.

Do not reuse, resterilize or reprocess the PlasmaBlade™ X device as it is supplied sterile and intended for Single Use Only. A device that has been resterilized or reprocessed may not perform properly and may result in patient or user injury.

When bending the blade, do not exceed a 45° angle. Do not bend more than three times. Excessive bending of the blade may compromise performance of the device or cause device failure, which could result in patient or user injury. Use finger force to bend the blade; do not use forceps as this could damage the device.

Avoid fluid contact with the handle and its interfaces and connections as this may result in patient or user injury, or device failure.

Position the cable to avoid creating a tripping hazard.

Position the cable to avoid patient contact to protect against high frequency current paths to the patient as this may result in patient or user injury. 2

The use of electrosurgery in the presence of internal or external electrically conductive implants is potentially hazardous due to concentration or redirection of HF currents.

Interference produced by electrosurgical equipment may adversely influence the operation of other electronic equipment. Interference with the function of or damage to cardiac pacemakers or other active implants may occur. Consult the active implant manufacturer for further information before proceeding with the surgery.

Direct contact with implanted leads can cause physical damage to the leads. Exercise caution around leads associated with any active implant; particularly those with thin insulation.

Do not use monopolar electrosurgery on small appendages, such as in finger surgery, as it can cause thrombosis or other unintended injury to tissue proximal to the surgical site.

The device should not be used near electrocardiograph electrodes as it can cause interference.

The PlasmaBlade™ device should only be used with a qualified Generator on output settings with peak voltages equal to or less than the rated accessory voltage (see Table 1).

Adequate ventilation to reduce electrosurgical smoke by use of a smokeplume evacuator or other means is recommended.

Precautions

The PlasmaBlade™ X device should only be used by qualified medical personnel possessing training in the surgical procedures to be performed.

Take care when handling the electrode tip to prevent possible damage to the tip and to prevent user injury.

Use the lowest power setting and the shortest activation time possible to achieve the desired end effect.

Unless the product is being used to spot coagulate a vessel, it is recommended to keep the electrode tip in motion while activated to avoid excessive eschar buildup. Excessive eschar buildup can compromise device performance.

Do not use sharp or abrasive instruments or materials to clean eschar buildup on the electrode tip as this may damage the tip.

When not in use, the device should be placed in the holster securely fastened to the surgical drape.

Prior to initial use, ensure that all package inserts, including warnings, cautions, instructions for use, as well as the selected Generator Operator’s Manual, are read and understood.

Prior to use, carefully inspect the package before opening. Do not use the device if the package appears damaged in any way. Return damaged packages to Medtronic Navigation, Inc.

Prior to use, inspect the PlasmaBlade™ X device for any defects. Do not use if insulation or connectors are damaged.

The PlasmaBlade™ X device is intended for use only with a qualified Generator.

Prior to use, make sure that the locking mechanism is in the locked position and unlocked only when adjusting the device shaft length.

Equipment list

PlasmaBlade™ X Compatible Generator

Optional Generator Compatible Footswitch

Patient Return Electrode, compatible with selected Generator

Instructions for useRead all instructions carefully. Failure to comply may lead to electrical or thermal injury, or cause device malfunction. Please refer to the Generator Operator’s Manual for step-by-step instructions regarding initial setup and preparation for surgery. The PlasmaBlade™ X device may only be used with a qualified Generator.Before surgery

Inspect the PlasmaBlade™ X package to ensure that it is unopened and undamaged. If it is damaged or the sterile seal is broken, do not use the device.

Remove the PlasmaBlade™ X device and holster from packaging using aseptic technique.

Inspect the device for any signs of damage. If the device is damaged it must not be used.

Attach the holster to the sterile drape using a clamp or tape. The PlasmaBlade™ X cable can be placed into the cutouts of the holster for convenience. NOTE: Ensure that the locking mechanism is in the locked position prior to use and unlocked only when adjusting the device shaft length.

For detailed instructions on the selected Generator use, please refer to the operator’s manual. Do not use the PlasmaBlade™ X device until reading and understanding the directions for the selected Generator.

Switch on the Generator to perform the initial setup and self-test.

Plug the PlasmaBlade™ X device into the Monopolar Connector of the Generator. Upon connection, the unit will alarm if the device is not recognized as a PlasmaBlade™ X device or if it fails a unit test. In event of an alarm, replace the device.

If using suction, connect the suction tubing from either a central or portable suction line to the connector on the handpiece.

If using the optional footswitch, plug the wireless receiver into the Footswitch Connector of the selected Generator. The footswitch can only be used to activate output on a monopolar device if a bipolar device is not connected.

Position the Patient Return Electrode on the patient and then connect the Patient Return Electrode to the Patient Connector receptacle of the qualified Generator.

Monopolar devices require a Patient Return Electrode. The Generator must detect proper Patient Return Electrode impedance before it can be active. The operator should confirm the presence of a properly connected Patient Return Electrode.

The qualified Generators have an Impedance indicator display . Ensure the impedance indicator is illuminated green before starting surgery. Refer to the Generator Operator’s Manual for more information on the impedance sensing feature and approved split-style return electrodes.

Remove the electrode tip protector before activation of device.

The Generator will display default power level settings for the PlasmaBlade™ X device upon connection. These settings must be verified and adjusted by the user to ensure the appropriate settings are selected. The lowest power setting possible should be used to achieve the desired end effect.Manipulating the device

Ensure power is not activated while manipulating the device or handling the electrode tip, as this may result in user injury.

To extend the shaft, firmly grasp the finger grip and pull away from the handpiece.

To collapse the shaft, firmly grasp the finger grip and push into the handpiece. Be careful not to pinch anything between the finger grip and the shaft when collapsing.

If needed, use finger force to bend the blade to a maximum of 45°. Inspect the blade for damage after bending and do not use if damaged. Do not bend more than three times. Excessive bending of the blade may cause device failure and could result in patient or user injury.

The tip can be rotated to any angle. Firmly grasp the finger grip and rotate to the desired position.

The shaft and finger grip may be locked into place at the desired position by rotating the locking mechanism counterclockwise. The shaft has been locked into place when the arrow lines up with the horizontal bar. Do not tighten beyond visual indicator.

To unlock the shaft and finger grip, turn the locking mechanism until loose.

During the surgeryPlace the device in the holster when not in use.

To cut, press the yellow button/pedal on the handswitch or footswitch.

To coagulate, press the blue button/pedal on the handswitch or footswitch. NOTE: Eschar buildup on the tip can be removed with gauze pads or by inserting the tip into the slot at the front of the holster and drawing the device backwards through the slot. Inspect the device for any signs of damage after cleaning.

After the surgery

Turn off the Generator.

Disconnect the PlasmaBlade™ X device, Footswitch, and Patient Return Electrode from the Generator.

Discard the PlasmaBlade™ X device after use. It is intended for Single Use Only. Do not reuse, resterilize, or reprocess. A device that has been resterilized or reprocessed may not perform properly and may result in patient or user injury.

How suppliedThe PlasmaBlade™ X device is supplied sterile and is intended for Single Use Only. Contents are sterile unless the package is opened or damaged. Do not reuse, resterilize, or reprocess the PlasmaBlade™ X device. The product is sterilized using Ethylene Oxide (EO).Customer servicePlease call Medtronic Customer Service at 866-777-9400 if you have any device returns or questions about Medtronic’s device.Limited express warrantyIF, PRIOR TO THE PRODUCT EXPIRATION DATE, THE STERILIZED DEVICE IS FOUND TO BE INOPERABLE DURING NORMAL AND PROPER USE IN ACCORDANCE WITH APPLICABLE INSTRUCTIONS, MEDTRONIC NAVIGATION, INC. WILL REPLACE THE PRODUCT AT NO CHARGE.
This Limited Express Warranty does not extend to a product where the user has compromised the sterile integrity of the package or the product is used after the product expiration date. A sterile package that has been compromised should not be used.
Disclaimer of Implied Warranties and Consequential Damages
MEDTRONIC NAVIGATION, INC. MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO EVENT SHALL MEDTRONIC NAVIGATION, INC. BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND. THE REMEDIES SET FORTH IN THE LIMITED EXPRESS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO CUSTOMER.

Features

All PlasmaBlade™ X dissection devices offer:

Non-stick coating for easy cleaning
Proprietary generator for consistent, reliable flow of energy
Steady thermal control for performance in wet or dry field

Additionally, certain PlasmaBlade™ X dissection device models have been customized to meet specific surgeon needs, with features such as:

Integrated smoke evacuation for improved visibility and safety⁴
Telescoping shaft for improved access
Integrated light for broad illumination of the surgical pocket

Lower temperature

Operates at temperatures up to 64% lower than traditional electrosurgery on cut settings⁴

Improved healing

Demonstrates reduced inflammatory response following skin incision and healed scar width compared to traditional electrosurgery²

Less surgical smoke

Produces 95% less surgical smoke than traditional electrosurgery on cut settings

Increased efficiency

Maintains cutting effectiveness and hemostatic ability when submerged in liquid fat or blood⁵

Reduced thermal damage

Produces 74% less thermal damage than traditional electrosurgery²

Decreased drainage

Reduces drainage duration and volume in mastectomy patients⁶

PlasmaBlade™ X family of products

PlasmaBlade™ X dissection device family

Closeup of the four PlasmaBlade X handpieces.

AEX™ generator

Lower temperatures. Less damage.

PlasmaBlade™ X dissection devices use less total energy and operate at significantly lower temperatures than traditional electrosurgery.

64% lower operating temperature for cutting^†,4
45% lower operating temperature for coagulation^†,1,2,4
74% reduced thermal injury depth²