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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4. Attach the holster to the sterile drape using a clamp or tape.
Cable
cutouts
Electrode
cleaning
slot
The PEAK PlasmaBlade cable can be placed into the cutouts of the holster for convenience.
5. For detailed instructions on the PULSAR Generator use, please refer to the operator’s manual. Do not
use the PEAK PlasmaBlade until reading and understanding the directions for the PULSAR Generator.
6. Switch on the PULSAR Generator to perform the initial setup and self-test.
7. Plug the PEAK PlasmaBlade into the Monopolar Connector of the PULSAR Generator. Upon
connection, the unit will alarm if the device is not recognized as a PEAK PlasmaBlade device, or if it fails
a unit test. In event of an alarm, replace the device.
8. If using suction, connect the suction tubing from either a central or portable suction line to the connector on the handpiece.
The PULSAR Generator will display default power level settings for the PEAK PlasmaBlade upon connection. These settings must be
verified and adjusted by the user to ensure the appropriate settings are selected. The lowest power setting possible sh ould be used to
achieve the desired end effect. Table1 indicates the PEAK PlasmaBlade settings available.
Table 1:
Tissue Effect
CUT
low hemostasis, low collateral damage
high hemostasis, higher collateral damage
COAG
low hemostasis, low collateral damage
high hemostasis, higher collateral damage
* When Cut level is changed from 5 to 6, there is a change in Cut mode from Low Cut to Medium Cut.
** When Cut level is changed from 8 to 9, Cut mode changes from Medium Cut to High Cut (Blend 1). Hence, output power will increase when the Cut level is
changed from 9 to 8.
*** When Coag level is changed from 5 to 6, Coag mode changes from Low Coag to High Coag. Hence, output power will increase when the Coag level is changed
from 6 to 5.
(LCD display)
PEAK PlasmaBlade Settings
Level
1
2 2 @ 40 1720
3 6 @ 40 1780
4 10 @ 40 1910
5 20* @ 40 1990
6
7 35 @ 600 708
8 50** @ 600 708
9 High Cut (Blend 1) 25 @ 600 1520
10 High Cut (Blend 2) 50 @ 600 2080
1
2 20 @ 600 1550
3 25 @ 600 1690
4 30 @ 600 1880
5 35 @ 600 2020
6
7 35 @ 1000 4260
8 40 @ 1000 4520
9 45 @ 1000 4720
10 50 @ 1000 5000
Mode
Low Cut
Medium Cut
Low Coag
High Coag
[W-RMS] @ Load (Ohms)
Power
0.5 @ 40 1530
20 @ 600 708
15 @ 600 1290
30*** @ 1000 3960
Maximum Output
Voltage (Vp–p)
9. If using the optional footswitch, plug the wireless receiver into the Footswitch Connector of the PULSAR Generator. The footswitch
can only be used to activate output on a monopolar device if a bipolar device is not connected.
10. Position the Patient Return Electrode on the patient and then connect the Patient Return Electrode to the Patient Connector
receptacle of the PULSAR Generator.
11. Monopolar devices require a Patient Return Electrode. The PULSAR Generator must detect proper Patient Return Electrode
impedance before it can be active. The operator should confirm the presence of a properly connected Patient Return Electrode.
12. The PULSAR Generator has an Impedance indicator display (Single Foil = , Split Foil = ) that indicates the type and
impedance level of the Patient Return Electrode in monopolar mode. The indicator will remain green with proper return electrode
impedance. The indicator will turn red when the unit does not detect proper return electrode impedance. Ensure proper return
electrode impedance before starting surgery. Refer to the PULSAR Generator Operator’s Manual for more information.
13. Remove the electrode tip protector before activation of device.
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Manipulating the Device
Rotate
Bend
Extend
(pull)
Collapse
(push)
Attach
Detach
Insertion line
Cleaning
slot
1. Ensure power is not activated while manipulating the device or handling the electrode tip, as this may result in user injury.
2. To extend the shaft, firmly grasp the finger grip and pull away from the
handpiece.
3. To collapse the shaft, firmly grasp the finger grip and push into the handpiece.
Be careful not to pinch anything between the finger grip and the shaft when
collapsing.
4. If needed, use finger force to bend the blade to a maximum of 45°. Inspect the
blade for damage after bending and do not use if damaged. Do not bend more
than three times. Excessive bending of the shaft may cause device failure and could result in patient or user injury.
5. The tip can be rotated to any angle. Firmly grasp the finger grip and rotate to the desired position.
Using the CoagCap (Ball Electrode)
1. Ensure power is not activated while handling the tip, as this may result in user injury.
2. Remove the ball electrode from the package by peeling open the ends of the pouch.
3. Inspect the tip for damage. Do not use if damaged.
4. The blade of the device must be straight for the ball electrode to securely attach.
5. Collapse the shaft of the PEAK PlasmaBlade or hold the shaft to prevent it from
moving. If the shaft is extended, it may move while you attach the ball electrode.
6. Connect the tip by holding the finger grip of the ball electrode an d pushing the tip
over the blade and onto the finger grip. The ball electrode should be flush with the
insertion line on the device and click into place.
7. Ensure the ball electrode is securely attached to the finger gr ip before use.
8. The ball electrode can be rotated to any direction and bent to a maximum of 90°.
To bend the ball electrode, apply force only in the bendable area.
9. To remove the ball electrode, grasp the finger grip and pull straight off. Hold the shaft of the PEAK PlasmaBlade to prevent it from
extending.
During Surgery
Place the device in the holster when not in use.
1. To cut, press the yellow button/pedal on the handswitch or footswitch.
2. To coagulate, press the blue button/pedal on the handswitch or footswitch.
NOTE: The ball electrode can be used with bo th cut and coagulate modes for various tissue effects. See
Table1 for more information.
NOTE: Eschar buildup on the tip can be removed manually with gloved fingers or gauze pads, or by
inserting the tip into the slot at the front of the holster and drawing the device backwar ds through the slot .
Inspect the device for any signs of damage after cleaning. Buildup on the ball electrode can be minimized
by using it on moist tissue at the lowest effective setting.
After Surgery
1. Turn off the PULSAR Generator.
2. Disconnect the PEAK PlasmaBlade, Footswitch, and Patient Return Electrode from the PULSAR Generator.
3. Discard the PEAK PlasmaBlade after use. It is intended for Single Use Only. Do not reuse, resterilize, or reprocess. A device that
has been resterilized or reprocessed may not perform properly and may result in patie nt or u ser injury.
How Supplied
The PEAK PlasmaBlade is supplied sterile and is intended for Single Use Only. Contents are sterile unless the package is opened or
damaged. Do not reuse, resterilize, or reprocess the PEAK PlasmaBlade. The product is sterilized using Ethylene Oxide (EO).
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MANUFACTURER
Medtronic Advanced Energy LLC
180 International Drive
Portsmouth, NH 03801 USA
Tel: 866-777-9400
Fax: 866-222-0900
www.medtronic.com/advancedenergy
Trademarks: PEAK, PEAK PlasmaBlade, and PULSAR are registered trademarks or trademarks of Medtronic Advanced Energy LLC.
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© 2012 Medtronic, Inc. All rights reserved.
LBL-00169 Rev A, 2012/04
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