Healthcare Professionals

Monopolar

Sealers

Indications, Safety, and Warnings

  

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Monopolar Sealers

Monopolar Sealers

Endo SH2.0 Sealing Hook

Indications

The Endo SH2.0™ sealing hook is a sterile, single-use monopolar electrosurgical device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency (RF) energy and saline for blunt dissection, 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, and thoracoscopic procedures.

The 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.

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.

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.

 

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.

 

DS3.5-C Dissecting Sealer

Indications

The dissecting sealer is a sterile, single-use monopolar electrosurgical device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency (RF) energy and saline for blunt dissection, hemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, abdominal and thoracic surgery.

The 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.

 

DS3.0 Dissecting Sealer

Indications

The Medtronic Advanced Energy Solid Cylinder monopolar device 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 blunt dissection, hemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery.

The 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.

Aquamantys System and Bipolar Sealers

Peak Plasmablade Device