Aquamantys 6.0 Bipolar Sealer
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 radio-frequency (RF) energy with saline for haemostatic 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: The device is not intended for cardiac applications.
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.
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 2.3 Bipolar Sealer
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 radio-frequency (RF) energy with saline for haemostatic 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: The device is not intended for cardiac applications.
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.
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 Malleable 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 radio-frequency (RF) energy and saline for haemostatic 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: The device is not intended for cardiac applications.
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.
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 Epidural Vein Sealer (EVS)
Indications: The AQUAMANTYS Epidural Vein Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the AQUAMANTYS Pump Generator for delivery of radio-frequency (RF) energy and saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Warnings: The device is not intended for cardiac applications.
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.
Precautions: Special care should be taken when using the device in the proximity of neural tissue.
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 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 radio-frequency (RF) energy and saline for blunt dissection and for haemostatic 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: The device is not intended for cardiac applications.
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.
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.
EndoFB3.0 Floating Ball
Indications: The Salient Surgical Technologies Monopolar Floating Ball is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio-frequency (RF) current and saline for haemostatic 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.
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.
EndoSH2.0 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 radio-frequency (RF) energy and saline for blunt dissection, haemostatic 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.
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 TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio-frequency (RF) current and saline for blunt dissection, haemostatic 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.
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-CDissecting 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 radio-frequency (RF) energy and saline for blunt dissection, haemostatic 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.
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 (100 V version, Only in Japan)
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 radio-frequency (RF) energy with saline for haemostatic 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: The System is not intended for cardiac or neurosurgical applications.
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.
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 (115 V version In US and Canada)
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 radio-frequency (RF) energy with saline for haemostatic 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: The System is not intended for cardiac or neurosurgical applications.
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.
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 (230 V version In EU)
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 radio-frequency (RF) energy with saline for haemostatic 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: The System is not intended for cardiac or neurosurgical applications.
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.
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. |
