Indications, Safety, and Warnings Aquamantys™ Bipolar Sealers

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™ and PlasmaBlade™ 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.
• If power levels were increased to compensate diminished performance, it is recommended to reduce power to the original or a lower level upon resumption of use.
• The output power selected should be as low as possible for the intended purpose.
• Failure of the high-frequency surgical equipment could result in an unintended increase of output power.
• 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.

Aquamantys™ 9.5 XL Bipolar Sealer 

Indications for Use

The Aquamantys™ 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with a qualified pump generator for delivery of radio-frequency (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

• Special care should be taken when using the device in the proximity of neural tissue to avoid damage to nerves and similar sensitive structures.

• The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
• 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. Activating device with tips pointing straight upward may result in inadequate saline flow to surface intended for treatment.
• If saline flow stops during the electrosurgical procedure, stop using the device and attempt to resume saline flow. Ensure that the pump tubing segment has been loaded properly into the pump head located on the generator and that the saline bag is not empty. If unable to resume saline flow, discontinue use and obtain a new device and return the used device to Medtronic Advanced Energy LLC.
• This device is not intended to be bent, or used as a pry, or any other use not cleared by the FDA. Bending or using the device as a pry could cause part breakage.
• The device is provided as a sterile, non-pyrogenic, single-use device. Do not resterilize or reuse this device. Reprocessing (resterilizing or reusing) this device can result in occluded saline apertures, reducing or preventing the flow of saline.
• Be aware that all exposed metal on the electrodes is capable of treating tissue. Use caution to avoid inadvertent treatment of tissue and adjacent structures.
• Be aware that the device employs RF coupled with saline. This coupling effect may result in a deeper tissue effect than conventional RF and has the potential for hot saline run-off onto delicate structures.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.
• Use suction to avoid activating the device in a pool of saline. Activating in pooled saline may reduce the hemostatic effectiveness of the device.
• Use suction to minimize the potential for activation of the device in a pool of blood. Activating in a pool of blood may limit the hemostatic effectiveness of the device or increase the risk of an electrode becoming clogged by coagulated blood.
• The tip of the suction wand should not touch the electrodes, since this might interfere with the proper function of the device. However, the tip of the suction wand can be as close as 1 – 2 mm from the electrodes when the device is activated.
• Overuse or excessive application of this device may result in contraction, inflammation or necrosis of tissue.
• Use of this device on skin may result in incisional complications such as necrosis or desiccation of the skin.
• Inspect the device and cord for breaks, cracks, nicks, or other damage before use. Failure to observe this caution may result in injury or electrical shock to the patient or surgical team.
• Interference produced by the operation of the RF surgical equipment may adversely influence the operation of other electronic equipment.
• Failure of the RF surgical equipment could result in an unintended increase of output power.
• Use the lowest setting possible to achieve the desired tissue effect to avoid overtreatment which could result in swelling, fluid, seroma or unintended tissue necrosis.

Precautions

• 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.
• The cable on the device should be positioned in a way to avoid contact with the patient or other cables.
• Consult the operating and user manuals for light sources, other electrosurgical units, and other ancillary devices for operating instructions, warnings, and cautions prior to their use in the same surgical field as Medtronic’s device.
• 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.
• Examine the shipping carton, packaging, sterile barrier, and device for any signs of transit damage. If there are any shortages, breakage, or apparent damage, do not use the device. Return the device to Medtronic Advanced Energy LLC and use a new device.
• This device does contain Phthalates.
• Use this device only with a qualified Pump Generator. Read the warnings, precautions, and instructions provided with the selected, qualified Pump Generator user guide before use. Specific instructions for the generator are not included in this IFU.
• Use the device with caution in the presence of pacemakers, as electrosurgical devices may cause interference with pacemakers or other active implants.
  • Place any monitoring electrodes being used as far away as possible from the device to avoid electrical interference with monitoring equipment. Avoid needle-monitoring electrodes.
  • Use monitoring systems incorporating high frequency current limiting devices.
  • The depth of effect is deeper and increases with time if the electrodes are held stationary with less depth of effect if the electrodes are moved over tissue.
  • High power settings result in deeper tissue effect than lower power settings.

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 patient should not come into contact with metal parts which are earthed or have an appreciable capacitance to earth (e.g. operating table supports, etc.).
• Skin to Skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
• 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.
• Before using the device, confirm the following: The cable from the device is connected to a qualified Pump Generator.
• All electrical connections are tight, clean, and dry.
• All fluid connections are secure.
• The generator is set at the desired power level.
• The saline delivery tubing and device have been fully primed with sterile saline (0.9% NaCl) solution

Aquamantys™ Malleable Bipolar Sealer with Light

Indications for Use

• The Aquamantys™ single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with a qualified pump generator for delivery of 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

• Special care should be taken when using the device in the proximity of neural tissue to avoid damage to nerves and similar sensitive structures.

• 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. Activating device with tips pointing straight upward may result in inadequate saline flow to surface intended for treatment.
• If saline flow stops during the electrosurgical procedure, stop using the device and attempt to resume saline flow. Ensure that the pump tubing segment has been loaded properly into the pump head located on the generator and that the saline bag is not empty. If unable to resume saline flow, discontinue use and obtain a new device and return the used device to Medtronic Advanced Energy LLC.
• This device is not intended to be used as a pry, or any other use not cleared by the FDA. Using the device as a pry could cause part breakage. Do not use surgical instruments to bend device shaft. Do not bend shaft laterally, twist shaft or bend excessively.
• The device is provided as a sterile, non-pyrogenic, single-use disposable device. Do not resterilize or reuse this device. Reprocessing (resterilizing or reusing) this device can result in occluded saline apertures reducing or preventing the flow of saline.
• Be aware that all exposed metal on the electrodes is capable of treating tissue. Use caution to avoid inadvertent treatment of tissue and adjacent structures.
• Be aware that the device employs RF coupled with saline. This coupling effect may result in a deeper tissue effect than conventional RF and has the potential for hot saline run-off onto delicate structures.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.
• Use suction to avoid activating the device in a pool of saline. Activating in pooled saline may reduce the hemostatic effectiveness of the device.
• Use suction to minimize the potential for activation of the device in a pool of blood. Activating in a pool of blood may limit the hemostatic effectiveness of the device or increase the risk of an electrode becoming clogged by coagulated blood.
• The tip of the suction wand should not touch the electrodes since this might interfere with the proper function of the device. However, the tip of the suction wand can be as close as 1 – 2 millimeters from the electrodes when the device is activated.
• Overuse or excessive application of this device may result in contraction, inflammation or necrosis of tissue.
• Use of this device on skin may result in incisional complications such as necrosis or desiccation of the skin.
• Inspect the device and cord for breaks, cracks, nicks, or other damage before use. Failure to observe this caution may result in injury or electrical shock to the patient or surgical team.
• Interference produced by the operation of the RF surgical equipment may adversely influence the operation of other electronic equipment.
• Failure of the RF surgical equipment could result in an unintended increase of output power.
• Use the lowest setting possible to achieve the desired tissue effect to avoid overtreatment which could result in swelling, fluid, seroma or unintended tissue necrosis.

Precautions

• Operate light prior to light utilization.
• 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.
• The cable on the device should be positioned in a way to avoid contact with the patient or other cables.
• Consult the operating and user manuals for additional light sources, other electrosurgical units, and other ancillary devices for operating instructions, warnings, and cautions prior to their use in the same surgical field as Medtronic’s device.
• 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.
• Examine the shipping carton, packaging, sterile barrier, and device for any signs of transit damage. If there are any shortages, breakage, or apparent damage, do not use the device. Return the device to Medtronic Advanced Energy LLC and use a new device.
• This device does contain Phthalates.
• Use this device only with a qualified Pump Generator. Read the warnings, precautions, and instructions provided with the selected, qualified Pump Generator user guide before use. Specific instructions for the generator are not included in this IFU.
• Use the device with caution in the presence of pacemakers, as electrosurgical devices may cause interference with pacemakers or other active implants
• Place any monitoring electrodes being used as far away as possible from the device to avoid electrical interference with monitoring equipment.Avoid needle-monitoring electrodes.
• Use monitoring systems incorporating high frequency current limiting devices.
• The depth of effect is deeper and increases with time if the electrodes are held stationary with less depth of effect if the electrodes are moved over tissue.
• High power settings result in deeper tissue effect than lower power settings.
• 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 patient should not come into contact with metal parts which are earthed or have an appreciable capacitance to earth (e.g. operating table supports, etc.).
• Skin to Skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
• 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.
• Before using the device, confirm the following:The cable from the device is connected to a qualified Pump Generator.
• All electrical connections are tight, clean, and dry.
• All fluid connections are secure.
• The generator is set at the desired power level.
• The saline delivery tubing and device have been fully primed with sterile saline (0.9% NaCl) solution.

Aquamantys™ 6.0 Bipolar Sealer

Aquamantys™ 3 Bipolar Sealer

Indications for Use

• The Aquamantys™ Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified pump generator for delivery of 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

• Special care should be taken when using the device in the proximity of neural tissue to avoid damage to nerves and similar sensitive structures.

• 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. Activating device with tips pointing straight upward may result in inadequate saline flow to surface intended for treatment.

If saline flow stops during the electrosurgical procedure ,stop using the device and attempt to resume saline flow. Ensure that the pump tubing segment has been loaded properly into the pump head located on the generator and that the saline bag is not empty. If unable to resume saline flow, discontinue use and obtain a new device and return the used device to Medtronic Advanced Energy LLC.

• This device is not intended to be bent, or used as a pry, or any other use not cleared by the FDA. Bending or using the device as a pry could cause part breakage.
• The device is provided as a sterile, non-pyrogenic, single-use device. Do not resterilize or reuse this device. Reprocessing (resterilizing or reusing) this device can result in occluded saline apertures, reducing or preventing the flow of saline.
• Be aware that all exposed metal on the electrodes is capable of treating tissue. Use caution to avoid inadvertent treatment of tissue and adjacent structures.
• Be aware that the device employs RF coupled with saline. This coupling effect may result in a deeper tissue effect than conventional RF and has the potential for hot saline run-off onto delicate structures.
• Protect delicate structures from hot saline run-off by utilization of suction or other protective measures.
• Use suction to avoid activating the device in a pool of saline. Activating in pooled saline may reduce the hemostatic effectiveness of the device.
• Use suction to minimize the potential for activation of the device in a pool of blood. Activating in a pool of blood may limit the hemostatic effectiveness of the device or increase the risk of an electrode becoming clogged by coagulated blood.
• The tip of the suction wand should not touch the electrodes, since this might interfere with the proper function of the device. However, the tip of the suction wand can be as close as 1 – 2 mm from the electrodes when the device is activated.
• Overuse or excessive application of this device may result in contraction, inflammation or necrosis of tissue.
• Use of this device on skin may result in incisional complications such as necrosis or desiccation of the skin.
• Inspect the device and cord for breaks, cracks, nicks, or other damage before use. Failure to observe this caution may result in injury or electrical shock to the patient or surgical team.
• Interference produced by the operation of the RF surgical equipment may adversely influence the operation of other electronic equipment.
• Failure of the RF surgical equipment could result in an unintended increase of output power.
• Use the lowest setting possible to achieve the desired tissue effect to avoid overtreatment which could result in swelling, fluid, seroma or unintended tissue necrosis.

Precautions

• 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.
• The cable on the device should be positioned in a way to avoid contact with the patient or other cables.
• Consult the operating and user manuals for light sources, other electrosurgical units, and other ancillary devices for operating instructions, warnings, and cautions prior to their use in the same surgical field as Medtronic’s device.
• 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.
• Examine the shipping carton, packaging, sterile barrier, and device for any signs of transit damage. If there are any shortages, breakage, or apparent damage, do not use the device. Return the device to Medtronic Advanced Energy LLC and use a new device.
• This device does contain Phthalates.
• Use this device only with a qualified Pump Generator. Read the warnings, precautions, and instructions provided with the selected, qualified Pump Generator before using. Specific instructions are not included in this manual.
• Use the device with caution in the presence of pacemakers, as electrosurgical devices may cause interference with pacemakers or other active implants.
  • Place any monitoring electrodes being used as far away as possible from the device to avoid electrical interference with monitoring equipment.Avoid needle-monitoring electrodes.
  • Use monitoring systems incorporating high frequency current limiting devices.
  • The depth of effect is deeper and increases with time if the electrodes are held stationary with less depth of effect if the electrodes are moved over tissue.
  • High power settings may result in deeper tissue effect than lower power settings.
  • 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 patient should not come into contact with metal parts which are earthed or have an appreciable capacitance to earth (e.g. operating table supports, etc.)