All CoolSeal devices are powered with the gold-standard efficacy of advanced bipolar RF vessel sealing technology. The 50W CoolSeal generator delivers precisely the power needed and automatically discontinues power when the seal is complete.
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Important Safety Information For CoolSeal® Trinity
The CoolSeal® Trinity sealer/divider/dissector is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal® Trinity sealer/divider/dissector can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
Do not use the CoolSeal® Trinity sealer/divider/dissector for tubal sterilization or tubal coagulation for sterilization procedures. The device is contraindicated for use in ENT procedures.
For further information related to warnings, cautions, and directions for use, please consult the Instructions For Use.
Important Safety Information For CoolSeal® Reveal
The CoolSeal® Reveal open sealer/divider/dissector is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal® Reveal open sealer/divider/dissector can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The CoolSeal® Reveal open sealer/divider/dissector is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
Do not use the CoolSeal® Reveal open sealer/divider/dissector for tubal sterilization or tubal coagulation for sterilization procedures.
For further information related to warnings, cautions, and directions for use, please consult the Instructions For Use.
Important Safety Information For CoolSeal® Mini
The CoolSeal® Mini sealer is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.
This device is contraindicated for use in ENT procedures. Do not use the device within 1 cm of a cochlear implant. Do not use the CoolSeal® Mini sealer for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this device on vessels in excess of 5 mm in diameter.
For further information related to warnings, cautions, and directions for use, please consult the Instructions For Use.
Important Safety Information For CoolSeal® Generator
The CoolSeal® generator is intended to provide Radio Frequency (RF) energy to compatible CoolSeal® instruments for vessel-sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used only with surgical devices compatible with the CoolSeal® technology.
For further information related to warnings, cautions, and directions for use, please consult the User’s Guide.
1. Internal Report NAR-VE-17357_2
2. Internal Report NAR-VE-17353_2
3. Internal Report NAR-EN-17455_1
4. 17557 Rev A CoolSeal Trinity Pediatric Indication Marketing Claim Report
5. Internal Report 16375_2
6. 16451 Rev 1 CoolSeal Reveal Chronic Study Seal Times and Vessel Count Engineering Report
7. Internal Report 16503_1
8. Internal Report 20088_1
9. Internal Report 20087_1
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