Medtronic PS210-031S-PINK Instructions for Use
PlasmaBlade™ X 3.0S
Single-Use Device Designed for Use
with Qualied Generators
Instructions For Use
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Device Description
The PlasmaBlade™ X 3.0S is a single-use, monopolar RF device. It is designed
to be used with the qualified Generators as part of the Surgery System. It can
be operated with the integrated handswitch or a qualified Footswitch. The
PlasmaBlade™ X 3.0S consists of a single bendable blade and telescoping
shaft that can be configured in both standard and extended length. The
finger grip also incorporates a suction lumen for the evacuation of smoke
and fluids. For a full list of qualified generators, see IFU insert card.
Locking Mechanism
Yellow Button (CUT)
Blue Button (COAG)
Bendable Blade
Finger Grip
Suction
Opening
Cable
Handpiece
Indications
The Surgery System is indicated for cutting and coagulation of soft tissue
during General, Plastic and Reconstructive (including but not limited to skin
incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic,
Arthroscopic, Spinal and Neurological procedures.
Contraindications
The PlasmaBlade™ X should not be used on small appendages or body parts,
as in circumcision.
Adverse Events
As a consequence of electrosurgery, damage to surrounding tissue through
iatrogenic injury could occur.
Warnings
• Observe re precautions at all times. An electrosurgical device may
provide an ignition source due to sparking and heating.
• Do not use in the presence of ammable anesthetics or oxidizing gases such
as nitrous oxide and oxygen. Do not activate the device until vapors from
alcohol-based skin prepping agents have dissipated. Naturally occurring
gases that accumulate in body cavities can also be an ignition source.
• Do not touch the electrode tip of the PlasmaBlade™ X device while power is
being applied as this may result in user injury.
• Do not contact metal objects and instruments with the PlasmaBlade™ X
device while power is being applied as unintended tissue damage and
electrode tip damage could occur.
• Activation of the handpiece when not in contact with target tissue may
cause capacitive coupling.
• Do not allow patient contact with grounded metal objects, as such contact
may result in patient or user injury.
• Activation of the handpiece simultaneously while aspirating uid may alter
the path of electrical energy away from target tissue.
• Activation of the PlasmaBlade™ X device outside the eld of view could
cause patient injury.
• Inadvertent patient contact may result in burns. When not in use, place the
device in a dry and nonconductive area away from the patient.
• Ensure that only the active tip of the device is in contact with the patient
during use.
• Monopolar devices require a Patient Return Electrode. Compatible generator
contact quality monitoring (CQM) systems will only function properly with
split-style patient return electrodes. Other patient return electrode products
may not identify loss of safe contact between the return electrode and the
patient, thereby failing to provide auditory or visual alarms and causing
patient injury or product damage. Refer to the manufacturer’s instructions for
application site and placement procedures when applying the Patient Return
Electrode. Do not rely entirely on the impedance sensing feature as it can be
aected by a damaged (shorted) Patient Return Electrode. It is recommended
that the operator verify appropriate placement and contact of the Patient
Return Electrode. Inadequate contact of the Patient Return Electrode may
result in patient alternate site burns or injury. Refer to the selected generator's
Operator's Manual for compatible Patient Return Electrodes.
• Do not reuse, resterilize or reprocess the PlasmaBlade™ X device as it is
supplied sterile and intended for Single Use Only. A device that has been
resterilized or reprocessed may not perform properly and may result in
patient or user injury.
• When bending the blade, do not exceed a 45° angle. Do not bend more
than three times. Excessive bending of the blade may compromise
performance of the device or cause device failure, which could result in
patient or user injury. Use nger force to bend the blade; do not use forceps
as this could damage the device.
• Avoid uid contact with the handle and its interfaces and connections as
this may result in patient or user injury, or device failure.
• Position the cable to avoid creating a tripping hazard.
• Position the cable to avoid patient contact to protect against high frequency
current paths to the patient as this may result in patient or user injury.
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