Monopolar

Aquamantys System and Bipolar Sealers

Aquamantys^® 3 Pump Generator

Indications

The Aquamantys3 Pump Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures.

The system is not intended for contraceptive tubal coagulation (permanent female sterilization).

Warnings

The System is not intended for neurosurgical applications.

Do not activate the device unless saline is flowing and it is in contact with tissue to be treated.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

Aquamantys^® Pump Generator

Indications

The Aquamantys Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency (RF) energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Warnings

The System is not intended for cardiac or neurosurgical applications.

Do not activate the device unless saline is flowing and it is in contact with tissue to be treated.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

9.5 XL Bipolar Sealer

Indications

The Aquamantys 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radiofrequency (RF) energy and saline for blunt dissection and for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Warnings

The device is not intended for neurosurgical applications.

Ensure that both electrodes are in contact with the tissue to be treated. Activation and saline flow occur simultaneously. Ensure that saline is flowing at the time of activation.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

Malleable Bipolar Sealer with Light (MBS)

Indications

The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radiofrequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Warnings

The device is not intended for neurosurgical applications.

Ensure that both electrodes are in contact with the tissue to be treated. Activation and saline flow occur simultaneously. Ensure that saline is flowing at the time of activation.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

6.0 Bipolar Sealer

Indications

The Aquamantys Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency (RF) energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Warnings

The device is not intended for neurosurgical applications.

Ensure that both electrodes are in contact with the tissue to be treated. Activation and saline flow occur simultaneously. Ensure that saline is flowing at the time of activation.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.  For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

2.3 Bipolar Sealer

Indications

The Aquamantys Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency (RF) energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Warnings

The device is not intended for neurosurgical applications.

Ensure that both electrodes are in contact with the tissue to be treated. Activation and saline flow occur simultaneously. Ensure that saline is flowing at the time of activation.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precautions

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

 

8.2L Bipolar Sealing with Cutting

Indications

The Aquamantys3 Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency (RF) energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Warnings

The System is not intended for neurosurgical applications.

Do not activate the device unless saline is flowing and it is in contact with tissue to be treated.

Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation.

Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

Precaution

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.

Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.

PlasmaBlade™ Device

PlasmaBlade™ 4.0

Indications

The 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.

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.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

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 PULSAR 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 PULSAR Generator.

 

PlasmaBlade™ 3.0S

Indications

The 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.

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.
• 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. 

• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

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 PULSAR 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 the PULSAR Generator.

 

PlasmaBlade™ PLUS

Indications

The 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.

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.
• Activation of the handpiece simultaneously while aspirating fluid may alter the path of electrical energy away from target tissue.
• Do not allow patient contact with grounded metal objects, as such contact may result in patient or user injury.
• 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.
• Do not insert the device into tissue past the blade, as damage to the device and unintended injury may occur.
• 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.
• 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.
• Ensure the ball electrode is securely attached to the finger grip before use. Do not continue to activate the device if the ball electrode tip becomes loose as injury might occur.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

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 PULSAR 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 PULSAR Generator.

 

PlasmaBlade™ Needle

Indications

The 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.

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. 

• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

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 PULSAR 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 the PULSAR Generator.

 

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.
• 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.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.

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, 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 PULSAR 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 PULSAR Generator.