Salient Endo FB3.0 Manual Del Usuario página 3

For example, for infants, the safest PRE position is on larger anatomy such
as the infant's back. Placing a PRE around the thigh, calf, or arm increases
the possibility of increased temperature at the PRE site. It is also important
not to have warming pads or blankets in operation over or around the PRE
during the time that a Salient device is activated as this could increase the
temperature at the site of the PRE.
When multiple PRE must be used, each PRE must be placed in an area
that has adequate surface area, musculature, and vasculature. This is
important, particularly on patients with small body weight or mass, such as
neonatal, infant and pediatric patients, or debilitated adult patients. See PRE
manufacturer's Instructions For Use for specific weight and current limitations.
Please be aware that Salient's monopolar devices employ RF energy coupled
with saline. This coupling effect may result in a deeper tissue effect than
conventional RF energy and has the potential for hot saline run off onto
delicate structures. Protect delicate structures from the hot saline run off by
utilization of suction or other protective measures.
Precautions
• DO NOT TREAT the following areas at any time:
• Dura
• Epidural veins
• Nerve roots
• Bone surfaces that are intended to be fused
• Vertebral end plates after discectomy
• Brain tissue
• Skin and skin edges
• Subcutaneous tissue
• Intact nerves
• Bone to be covered by implant
• Intact tendons and ligaments
• 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.
• Examine the shipping carton, packaging, sterile barrier and device for any
signs of transit damage. If there are any shortages, breakage or apparent
damage, do not use the device. Return the device to Salient and use a
new device.
• The device is provided as a sterile, latex free, non-pyrogenic, single-use
disposable device. Do not resterilize or reuse this device.
• For Endo FB3.0 and Endo SH2.0 devices, carefully insert and withdraw the
device from trocar cannulas to avoid possible damage to the devices and/or
injury to the patient.
• Use the device with an appropriate electrosurgical generator. Recommended
generators are listed in Appendix 1, Recommended Generator Settings,
document 70-10-1353.
• Do not activate the device unless it is in contact with tissue to be treated.
• Use the device with caution in the presence of pacemakers, as electrosurgical
devices may cause interference with pacemakers or other active implants.
• Before using the device, confirm the following:
• The cable from the device is connected to the monopolar output of the
electrosurgical generator.
• The dispersive electrode return pad is in place and appropriately
connected, according to the manufacturer's instructions.
• All electrical connections are tight, clean and dry.
• All fluid connections are secure.
• The generator is set at the desired power level.
• The saline delivery tubing and device have been fully primed with sterile
saline (0.9% NaCl) solution.
Setting Up the Monopolar Device
Warning:
Electric Shock Hazard
•
connected and that no metal pins are exposed.
Precautions:
• Read the instructions, warnings, and precautions provided with the
electrosurgical device before using.
• Inspect the device and cord for breaks, cracks, nicks, or other damage
before use. Failure to observe this caution may result in injury or electrical
shock to the patient or surgical team.
• Set the RF energy power to the lowest setting for desired tissue effect.
• Place any monitoring electrodes being used as far away as possible from
the device.
• Avoid needle monitoring electrodes.
• Use monitoring systems incorporating high frequency current limiting
devices.
STEP 1: Place dispersive electrode pad on patient, according to its
manufacturer's instructions, and connect pad to appropriate
generator.
STEP 2: Using aseptic technique, open the package and place contents on
sterile field.
STEP 3: Set up and prime the saline delivery system according to
manufacturer's Instructions For Use. Use an appropriate volume I.V.
bag of sterile saline (0.9% NaCl) and a primary I.V. Tubing Set with
a drip chamber.
STEP 4: Using aseptic technique, remove the vented luer cap from the
device tubing. Connect tubing from the device to tubing from the
saline delivery system, making sure the luer connections are secure.
. Ensure that the device plug is correctly
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