PEAK PlasmaBlade Needle
The PEAK® 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
The PEAK PlasmaBlade® Needle should not be used on small
appendages or body parts, as in circumcision.
As a consequence of electrosurgery, damage to surrounding tissue
through iatrogenic injury could occur.
- Observe fire precautions at all times. An electrosurgical
device may provide an ignition source due to sparking and
- Do not use in the presence of flammable 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 PEAK PlasmaBlade Needle while power is being
applied as this may result in user injury.
- Do not contact
metal objects and instruments with the PEAK PlasmaBlade Needle while
power is being applied as unintended tissue damage and electrode tip
damage could occur.
Activation of the PEAK PlasmaBlade Needle
outside the field of view could cause patient injury.
- 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 fluid may alter the path of electrical energy away from
- Inadvertent patient contact may result in
burns. When not in use, place the device in a dry and nonconductive
area away from the patient.
- 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 and displayed 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 affected 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.
not reuse, resterilize, or reprocess the PEAK PlasmaBlade Needle 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
PEAK PlasmaBlade Needle shaft, do not exceed a 45° angle with the
plane of the shaft. Do not bend more than three times. Bend the
shaft, not the tip. Excessive bending of the shaft may compromise
performance of the device or cause device failure, which could
result in patient or user injury. Use finger force to shape the
shaft; do not use forceps as this could damage the device.
- Avoid fluid contact with the handle and its interfaces and
connections, as this may result in patient or user injury, or device
- 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.
The use of
electrosurgery in the presence of internal or external cardiac
pacemakers is potentially hazardous. Interference from the
electrical current can cause device malfunction. Consult the cardiac
pacemaker manufacturer for further information before proceeding
with the surgery.
- Do not use monopolar electrosurgery on
small appendages, such as in finger surgery, as it can cause
thrombosis or other unintended injury to tissue proximal to the
- The device should not be used near
electrocardiograph electrodes as it can cause interference.
- The PEAK PlasmaBlade Needle should only be used by qualified
medical personnel possessing training in the surgical procedures to
- Take care when handling the electrode tip to
prevent possible damage to the tip and to prevent user injury.
- Use the lowest power setting and the shortest activation time
possible to achieve the desired end effect.
- Unless the
product is being used to spot coagulate a vessel, it is recommended
to keep the electrode tip in motion while activated to avoid
excessive eschar buildup. Excessive eschar buildup can compromise
- Do not use sharp or abrasive
instruments or materials to clean eschar buildup on the electrode
tip as this may damage the tip.
- When not in use, the device
should be placed in the holster securely fastened to the surgical
- Prior to initial use, ensure that all package inserts,
including warnings, cautions, instructions for use, as well as the
PULSAR Generator Operator’s Manual, are read and understood.
- Prior to use, carefully inspect the package before opening. Do
not use the device if the package appears damaged in any way. Return
any damaged packages to Medtronic Advanced Energy, LLC.
- Prior to use, inspect the PEAK PlasmaBlade Needle for any
defects. Do not use if insulation or connectors are damaged.
- The PEAK PlasmaBlade Needle is intended for use only with the