Indications, Safety, and Warnings
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 the return electrode pad manufacturer’s instructions for use (IFU) 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 (United States) 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 (IFU).
Endo FB3.0 floating ball
Indications
The monopolar floating ball from Medtronic Transformative Solutions 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 (IFU) 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 (United States) 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 (IFU).
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 (IFU) 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 (United States) 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 (IFU).
DS3.0 dissecting sealer
Indications
The Medtronic Transformative Solutions 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 (IFU) 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 (United States) 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 (IFU).
DS3.0 dissecting monopolar sealer
DS3.5-C dissecting monopolar sealer
Endo FB3.0 floating ball monopolar sealer