Indications For Use - Salient Endo FB3.0 Manual Del Usuario

System Diagram Below is a simple schematic of how the device connects to
other instruments. Use the device with any saline delivery system that will
deliver 4–20 ml/minute (2-6 ml/minute for Endo FB3.0) of sterile saline (0.9%
NaCl) flow to the device. The saline delivery system can be any infusion pump
with flow rate setting capability or an intravenous saline bag and intravenous
tubing with a 15 drops/ml drip chamber, which can be connected to the
device.
Salient's
Device
Patient
Dispersive
Electrode
Endo FB3.0 Floating Ball (12-201-1):

Indications For Use

The Endo FB3.0™ device is a sterile, single-use electrosurgical device intended to be
used in conjunction with an electrosurgical generator for delivery of radio-frequency
energy 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 device is not intended for contraceptive tubal coagulation (permanent female
steriization).
Endo SH2.0 Sealing Hook (13-201-1):
Indications For Use
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 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).
DS3.0 and DS3.5-C Dissecting Sealers (13-101-1 and 13-121-1):
Indications For Use
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 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 for these devices are:
• The device is not intended for contraceptive tubal coagulation (permanent
female sterilization).
• The device 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 and obtain a new device
and return the used device to Salient.
• Surgery should be performed by persons with adequate training and preparation.
Personnel should fully understand the nature and use of RF energy 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.
• DO NOT use electrosurgery in the presence of flammable anesthetics or
other flammable gases, near flammable fluids or objects, or in the presence
of oxidizing agents, as fire could result.
• Examine all devices to be connected to the electrosurgical generator. After
connection, ensure that they are functioning as intended.
• The cable on the device should be positioned in a way to avoid contact with
the patient or other cables.
• Consult the operating and user manuals for other light sources,
electrosurgical units, saline delivery systems and other ancillary devices for
operating instructions, warnings and cautions prior to their use in the same
surgical field as Salient's device.
• In the event that a higher than normal electrosurgical power setting is
required, before changing power settings, check all instrument connections,
cables and patient contacts. If all connections, cables and patient contacts
are fault-free, then increase power settings in small increments, checking
carefully after each change.
• 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.
• Caution: When used in solid organ resections, Salient monopolar devices
are often applied with higher current and relatively long activation times,
different from standard, traditional electrosurgical usage. Prior to using
higher current, long-duration systems such as Salient, assure that all
components of the system set-up are compatible, including Salient devices,
generator, and patient return electrodes (PRE). Assure that the area of the
PRE placement has adequate surface area, musculature, and vasculature
for the anticipated current and duration of use. It is important that there be
sufficient musculature and vasculature for current distribution so that there
are no current concentrations, such as at the edges. Refer to manufacturer's
Instructions For Use for all devices used, including the generator, patient
return electrode, and all other associated equipment. As stated in the
manufacturer's Instructions For Use for PRE "Do not place the patient return
electrode on anatomy insufficient to allow proper return."
Footswitch
(optional)
2
Saline Delivery System
Electrosurgical Generator