Medtronic PEAK PlasmaBlade Instruction Manual

PEAK PlasmaBlade™ PLUS

Yellow Button (CUT)

Finger Grip

Bendable Blade

Handpiece

Blue Button (COAG)

Cable

Suction
Opening

CoagCap (Ball Electrode)

Device Description

The PEAK PlasmaBlade

™

PLUS is a single-use, monopolar
RF device. It is designed to be used with the PULSAR
Generator as part of the PEAK Surgery System. It can be
operated with the integrated handswitch or the PULSAR
Footswitch. The PEAK PlasmaBlade PLUS consists of a
single bendable blade and telescoping shaft that can be
configured in both standard and extended length. The finger
grip incorporates a suction lumen for the evacuation of
smoke and fluids. A CoagCap (ball electrode) attaches to the
finger grip to allow a broader application of energy.

Indications

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 Neurological
procedures.

Contraindications

The PEAK 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 fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking and heating.

• 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 while power is being applied as this may result in user injury.

• Do not contact metal objects and instruments with the PEAK PlasmaBlade 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.

• Activation of the handpiece simultaneously whi le aspirating fluid may alter the path of electrical energy away from target tissue.

• Do not allow patient contact with grounded metal objects, as such contact may result in patient or user injury.

• Activation of the PEAK PlasmaBlade outside the field 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 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 p r ocedures 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.

• Do not reuse, resterilize or reprocess the PEAK PlasmaBlade 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 shaft may

compromise performance of the device or cause device failure, which could result in patient or user injury. Use finger force to bend
the blade; do not use forceps as this could damage the device.

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• Avoid fluid 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.

• 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 pa cemaker 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 surgical site.

• The device should not be used near electrocardiograph electrodes as it can cause interference.

• Ensure the ball electrode is securely attached to the finger grip before use. Do not continue to activate the device if the ball

electrode tip becomes loose as injury might occur.

Precautions

• The PEAK PlasmaBlade should only be used by qualified medical pers onn el po ss es s ing trai nin g in the surgical procedures to be

performed.

• 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 device performance.

• 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 faste ned to the surgical drape.

• 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 for any defects. Do not use if insulation or connectors are damaged.

• The PEAK PlasmaBlade is intended for use only with the PULSAR Generator.

Equipment List

• PULSAR Generator

• Optional PULSAR Footswitch

• Any standard Patient Return Electrode

Instructions For Use

• Read all instructions carefully. Failure to comply may lead to electrical or thermal injury, or cause device malfunction.

• Please refer to the PULSAR Generator Operator’s Manual for step-by-step instructions regarding initial setup and preparation for

surgery. The PEAK PlasmaBlade may only be used with the PULSAR Generator.

Before Surgery

1. Inspect the PEAK PlasmaBlade package to ensure that it is unopened and undamaged. If it is damaged or the sterile seal is broken,

do not use the device.

2. Remove the PEAK PlasmaBlade and holster from packaging using aseptic technique.

3. Inspect the device for any signs of damage. If the device is damaged it must not be used.

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