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 TranscollationTM and PEAK 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.

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 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

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.

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.


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

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.

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.


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

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.

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.


6.0 BIPOLAR SEALER

INDICATIONS

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).

WARNINGS

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.

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.


2.3 BIPOLAR SEALER

INDICATIONS

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).

WARNINGS

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.

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.


8.2L BIPOLAR SEALER WITH CUTTING

INDICATIONS

The Aquamantys3 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. 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

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.

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.