Indications, Safety, and Warnings PlasmaBlade Soft-Tissue Dissection Devices

AEX Generator

Indications

The AEX Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF energy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological, Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Contraindications

The AEX Generator with Aquamantys Transcollation^TM and PlasmaBlade^TM should not be used on small appendages or body parts, as in finger surgery or circumcision.

Warnings and Cautions

Electrosurgery has been used safely in many procedures. Physicians should be familiar with the medical literature, complications, and hazards associated with electrosurgery before beginning any electrosurgical procedure. Electrosurgery, if misused, can pose dangers to patients or staff, as well as other equipment. Safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the user, such as surgical training and clinical decision making. The warnings and cautions presented in this manual should be read, understood, and followed for safety purposes.

Warnings for Use

It is recommended that physicians utilize pre-clinical training, review of pertinent literature, and other appropriate educational tools before attempting newer surgical procedures, such as endoscopic, laparoscopic, or thoracoscopic procedures.

Read the warnings, precautions, and instructions provided with AEX disposable handpieces before using. Specific instructions are not included in this manual.

If using the optional footswitch, ensure that the footswitch is not inadvertently depressed to prevent the device from being unintentionally activated. Place the footswitch in a location necessitating deliberate action in order to activate the unit.

If using the optional footswitch, only the primary surgeon using the handpiece should operate the footswitch. Unintentional activation may occur if the footswitch is activated by a separate user, which may result in patient or user injury.

Ensure that the sound volume on the Generator is adequately adjusted so that the activation tones are clearly heard. The activation tones are intended to alert the user that the device is active. This will help prevent unintended contact with the device which could result in patient or user injury.

Examine the handpiece before connecting it to the AEX Generator. After connecting the handpiece, ensure that the handpiece and the unit are functioning as intended.

Consult the operating and user manuals for light sources and other ancillary devices for warnings, precautions, and instructions prior to their use with the AEX Generator.
Position the AEX Generator away from life supporting and/or monitoring systems to reduce/avoid interference with these systems.

The interference produced by the operation of RF surgical equipment may adversely influence the operation of other electronic equipment.

DO NOT use electrosurgery in the presence of flammable anesthetics or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents as fire could result.

The cable on the disposable handpieces should be positioned in a way to avoid contact with the patient or other cables.

Monitoring systems incorporating RF current limiting devices are recommended.
For surgical procedures where the RF current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.

During use, a diminished power output may indicate that the Patient Return Electrode connection has been compromised, failure of an electrical lead, active electrode insulation failure, or excessive eschar buildup on the active electrode tip. Do not increase the power output before checking for obvious defects or improper connections. Check for effective contact of the Patient Return Electrode to the patient any time that the patient is moved after initial application of the Patient Return Electrode.

If the system resets due to a power interruption or low voltage, the system will check for effective contact of the Patient Return Electrode, however the user should verify effective contact of the Patient Return Electrode visually prior to resuming electrosurgery.

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.

Studies have shown that smoke generated during electrosurgery may be harmful to surgical personnel. These studies recommend the use of a surgical mask and adequate ventilation of the smoke using a surgical smoke evacuator or other means.

Neuromuscular stimulation can occur causing unexpected patient movement, especially with modes producing electrical arcs between the active device electrode and tissue. Use caution in proximity to neural structures.

Observe all caution and warning notices printed on the unit.

Operating room staff should never contact the handpiece tip while the Generator is active, as injury may result.

The tip of a recently activated handpiece may be hot enough to cause patient burns or ignite surgical drapes or other flammable material. When not in use, store the device in an electrically insulated container or holster. Never place or rest a handpiece on the patient.

PlasmaBlade 4.0

Indications

PlasmaBlade™ dissection devices are 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.

Contraindications

The PlasmaBlade should not be used on small appendages or body parts, as in circumcision.

Adverse Events

As 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 while power is being applied as this may result in user injury.
Do not contact metal objects and instruments with the PlasmaBlade while power is being applied as unintended tissue damage and electrode tip damage could occur.
Activation of the PlasmaBlade outside the field of view could cause patient injury.
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.
Inadvertent patient contact may result in burns. When not in use, place the device in a dry and nonconductive area away from the patient.
Monopolar devices require a Patient Return Electrode. The unit must detect proper Patient Return Electrode impedance before Generator output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The unit presents audible and visible alarms if the unit detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable Generator output. 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.
Do not reuse, resterilize or reprocess the PlasmaBlade 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 PlasmaBlade shaft, do not exceed a 45° angle with the plane of the shaft. Do not bend more than three times. Bend the shaft, not the tip. Excessive bending of the shaft may compromise performance of the device or cause device failure, which could result in patient or user injury. Use finger force to shape the shaft; 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 patient contact to protect against high frequency current paths to the patient as this may result in patient or user injury.
The use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous. Interference from the electrical current can cause device malfunction. Consult the cardiac pacemaker manufacturer for further information before proceeding with the surgery.
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.

Precautions

The PlasmaBlade 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 any damaged packages to Medtronic Advanced Energy, LLC.
Prior to use, inspect the PlasmaBlade for any defects. Do not use if insulation or connectors are damaged.
The PlasmaBlade is intended for use only with qualified generators.

PlasmaBlade 3.0S

Indications

PlasmaBlade dissection devices are 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.

Contraindications

The PlasmaBlade should not be used on small appendages or body parts, as in circumcision.

Adverse Events

As 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 while power is being applied as this may result in user injury.
Do not contact metal objects and instruments with the PlasmaBlade 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 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. The unit must detect proper Patient Return Electrode impedance before Generator output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The unit presents audible and visible alarms if the unit detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable Generator output. 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.
Do not reuse, resterilize or reprocess the PlasmaBlade 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 shaft 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.
The use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous.
Interference from the electrical current can cause device malfunction. Consult the cardiac pacemaker 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.

Precautions

The PlasmaBlade 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 Advanced Energy, LLC.
Prior to use, inspect the PlasmaBlade for any defects. Do not use if insulation or connectors are damaged.
The PlasmaBlade is intended for use only with qualified generators.
Prior to use, make sure that the locking mechanism is in the locked position and unlocked only when adjusting the device shaft length.

PlasmaBlade Needle

Indications

Contraindications

The PlasmaBlade Needle should not be used on small appendages or body parts, as in circumcision.

Adverse Events

As 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 Needle while power is being applied as this may result in user injury.
Do not contact metal objects and instruments with the PlasmaBlade Needle while power is being applied as unintended tissue damage and electrode tip damage could occur. Activation of the PlasmaBlade Needle outside the field of view could cause patient injury.
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.
Inadvertent patient contact may result in burns. When not in use, place the device in a dry and nonconductive area away from the patient. 
Monopolar devices require a Patient Return Electrode. The unit must detect proper Patient Return Electrode impedance before Generator output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The unit presents audible and visible alarms if the unit detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable Generator output. 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.
Do not reuse, resterilize, or reprocess the PlasmaBlade Needle 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 PlasmaBlade Needle shaft, do not exceed a 45° angle with the plane of the shaft. Do not bend more than three times. Bend the shaft, not the tip. Excessive bending of the shaft may compromise performance of the device or cause device failure, which could result in patient or user injury. Use finger force to shape the shaft; 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 patient contact to protect against high frequency current paths to the patient as this may result in patient or user injury.
 The use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous. Interference from the electrical current can cause device malfunction. Consult the cardiac pacemaker manufacturer for further information before proceeding with the surgery.
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.

Precautions

The PlasmaBlade Needle 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 any damaged packages to Medtronic Advanced Energy, LLC.
Prior to use, inspect the PlasmaBlade Needle for any defects. Do not use if insulation or connectors are damaged.
The PlasmaBlade Needle is intended for use only with qualified generators.

PlasmaBlade TnA

Indications

The PlasmaBlade TnA device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

Adverse Events

As 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.
Proper suction connection is important to prevent a build-up of flammable or oxidizing gases at the surgical site. During use, monitor the device for inadequate suction performance, which might be apparent by excessive/visible smoke or burnt odor. Use the Cleaning Brush providing to remove excess eschar build-up and maintain a clear channel for suction.
Do not contact metal objects and instruments with the PlasmaBlade while power is being applied as unintended tissue damage and electrode tip damage could occur.
Activation of the PlasmaBlade outside the field of view could cause patient injury.
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.
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. The unit must detect proper Patient Return Electrode impedance before generator output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The unit presents audible and visible alarms if the unit detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable generator output. 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.
Do not reuse, resterilize or reprocess the PlasmaBlade 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.
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 patient contact to protect against high frequency current paths to the patient as this may result in patient or user injury.
Position the cable to avoid creating a tripping hazard.
The use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous. Interference from the electrical current can cause device malfunction. Consult the cardiac pacemaker manufacturer for further information before proceeding with the surgery.
The device should not be used near electrocardiograph electrodes as it can cause interference.
Ensure that the tip is fully seated into the suction shaft as any gaps may cause unintended tissue damage, and injury could occur.
Excessive bending may compromise performance and cause device failure, resulting in patient or user injury.
Postoperative bleeding is inherent to surgical procedures and may occur regardless of the electrosurgical hemostatic device used. Appropriate and thorough post-op surgical care should be administered to the patient.

Precautions

The PlasmaBlade 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.
Take care when cleaning around the adenoid wire electrode, as excessive force may cause damage or breakage.
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, including reduced or clogged suction.
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 a secure sterile location to prevent accidental damage to the tip.
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 any damaged packages to Medtronic Advanced Energy, LLC.
Prior to use, inspect the PlasmaBlade for any defects. Do not use if insulation or connectors are damaged.
The PlasmaBlade is intended for use only with the qualified generators.