EnSeal® Tissue Sealing Device Instruments, Generator and Footswitch

Product Codes:
NSEAL514H, NSEAL514RH, NSEAL525H, NSEAL525RH, NSEAL535H,
NSEAL535RH, NSEAL545H, NSEAL545RH, ETRIO314H, ETRIO325H, ETRIO335H,
ETRIO345H, NSEAL514E, NSEAL514RE, NSEAL525E, NSEAL525RE, NSEAL535E,
NSEAL535RE, NSEAL545E, NSEAL545RE, ETRIO314E, ETRIO325E, ETRIO335E,
ETRIO345E, RF60 and EEF
1. Description, Function, Intended Medical Usage
The EnSeal® Tissue Sealing System consists of disposable instruments and an
electrosurgical generator and footswitch. The EnSeal disposable devices are tubular
instruments with grasping jaws at the distal end, which are actuated by a handle at the
proximal end of the device. The distal end contains bipolar electrodes for sealing vessels,
and a mechanical cutting blade for transecting vessels and soft tissues. EnSeal device
jaws are unique in that they have a patented jaw design that allows for uniform
compression and temperature control. Devices are provided sterile and are intended for
single use only. An electrical cable connects the device to the electrosurgical
radiofrequency generator. The radiofrequency generator supplies power to the EnSeal
disposable instruments. The EnSeal devices with TAPtronic have a handswitch for power
activation which allows the user an alternative to footswitch power activation.
The EnSeal device jaws employ a unique bipolar technology which provides various
enhanced tissue sealing effects. The active electrode is contained within the jaw
mechanism, unexposed to surrounding tissues, with the jaw itself as the return path. The
jaws grasp, enclose, and compress the tissue while current is directed only to the tissue
captured within the jaws. Less heat is required to obtain a seal as the tissue volume is
minimized through compression, energy is focused on the captured, tissue, and the vessel
is reformed through compression into a secure seal. This technology also provides
temperature control to minimize undesirable thermal effects. As the tissue begins to
desiccate, the electrode maintains the conductive path and the current continues to flow at
the proper temperature required to achieve an effective seal. The cutting mechanism is in
the shape of an ―I‖-beam, referred to as the I-Blade™. The I-Blade provides additional
compression to the tissue in order to enhance seal-ability as the blade is advanced along
the length of the jaw.
EnSeal devices have a 360° rotatable shaft and are available in a 5mm shaft diameter, and
various shaft lengths (14cm, 25cm, 35cm, and 45cm), as well as a variety of tip
configurations which include a 5mm dia. Standard Tip (with 90° jaw corner and grasping
rat tooth), 5mm dia. Round Tip, and 3mm dia. TRIO (with curved jaw).
The EnSeal devices are powered by EnSeal generators RF60. The EnSeal® RF-60
Generator is 100V/240V is 50/60Hz input microprocessor controlled quasi-sinusoidal
waveform, 60W maximum output electrosurgical radiofrequency generator (RFG). The
EnSeal® RF60 Generator controls and monitors the RF energy transmission to the tissue
through the EnSeal® Tissue Sealing Device (EnSeal Device). An electrical cable
connects the EnSeal instrument to the radiofrequency generator.
There is an Erbe Generator call the VIO 300D. EnSeal devices that work with the Erbe
VIO have a unique cable (8 pin), and require a special adapter (provided by Erbe). These
Erbe functional devices are designated with special product codes ending in the letter
―E‖. Erbe generators are sold in Europe.
Lifetime or Shelf life of the product --No assigned shelf life, Lifetime is 3 years from the
date of manufacture
RF60 Generator Package Includes RF Generator, IFU, power cord, and footswitch