PlasmaBlade™ PLUS
Single-Use Device Designed for Use
with Qualied Generators
Instructions For Use
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PlasmaBlade™ PLUS
Device Description
The PlasmaBlade™ PLUS is a single-use, monopolar RF device. It is designed
to be used with the qualied Generators as part of the Surgery System. It can
be operated with the integrated handswitch or a qualied Footswitch. The
PlasmaBlade™ PLUS consists of a single bendable blade and telescoping shaft
that can be congured in both standard and extended length. The nger grip
also incorporates a suction lumen for the evacuation of smoke and uids.
A CoagCap (ball electrode) attaches to the nger grip to allow a broader
application of energy. For a full list of qualied generators, see IFU insert card.
Yellow Button (CUT)
Locking Mechanism
Blue Button (COAG)
Cable
Handpiece
Cable Clips
Bendable Blade
Finger Grip
CoagCap (Ball Electrode)
Suction
Opening
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 aps), ENT, Gynecologic, Orthopaedic,
Arthroscopic, Spinal and Neurological procedures.
Contraindications
The PlasmaBlade™ 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™ device while power is
being applied as this may result in user injury.
• Do not contact metal objects and instruments with the PlasmaBlade™
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™ 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.
• Do not insert the device into tissue past the blade, as damage to the device
and unintended injury may occur.
• Monopolar devices require a Patient Return Electrode. The unit must detect
proper Patient Return Electrode impedance before Generator output can be
active. The impedance is continuously monitored while in Monopolar Mode.
The unit presents audible and visible alarms if the unit detects improper
impedance with the Patient Return Electrode in Monopolar Mode and
will disable Generator output. 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. Inadequate contact of the
Patient Return Electrode may result in patient alternate site burns or injury.
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