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Aquamantys System

and Bipolar Sealers

Indications, Safety, and Warnings

  

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

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.

 

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.

 

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 6.0 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 2.3 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.

Monopolar Sealers

Endo FB3.0 Floating Ball

Indications

The Monopolar Floating Ball from Medtronic Advanced Energy is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency (RF) current and saline for hemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures.

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

Warnings

The System is not intended for cardiac or neurosurgical applications.

If saline flow stops during the electrosurgical procedure, stop using the device and attempt to resume saline flow. Ensure that the saline source is adequate and the saline delivery system is functioning properly. If unable to resume saline flow, discontinue use.

Use of a return electrode pad is required for use of this device. Assure that all connections are secure and monitor closely to maintain appropriate patient contact during use. Consult return electrode pad manufacturer’s Instructions For Use for proper placement and use.

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.