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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).
The AEX™ Generator with Aquamantys™, Transcollation™ and PlasmaBlade™ should not be used on small appendages or body parts, as in finger surgery or circumcision.
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.
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.
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.
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.
Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions 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).
DO NOT TREAT the following areas at any time:
Dura
|
Epidural veins
|
Nerve roots
|
Bone surfaces that are intended to be fused
|
Skin and skin edges
|
Vertebral end plates after discectomy
|
Intact nerves
|
Subcutaneous tissue
|
Intact tendons and ligaments
|
Bone to be covered by implant
|
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.
Indications for Use
DO NOT TREAT the following areas at any time:
Dura
|
Epidural veins
|
Nerve roots
|
Bone surfaces that are intended to be fused
|
Skin and skin edges
|
Vertebral end plates after discectomy
|
Intact nerves
|
Subcutaneous tissue
|
Intact tendons and ligaments
|
Bone to be covered by implant
|
DO NOT TREAT the following areas at any time:
Dura
|
Epidural veins
|
Nerve roots
|
Bone surfaces that are intended to be fused
|
Skin and skin edges
|
Vertebral end plates after discectomy
|
Intact nerves
|
Subcutaneous tissue
|
Intact tendons and ligaments
|
Bone to be covered by implant
|
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.
The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys 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).
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.
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.
Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use.