PlasmaBlade™ PLUS
Single-Use Device Designed for Use
with Qualied Generators
Instructions For Use
© 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and
Further, Together are trademarks of Medtronic. All other brands are
trademarks of a Medtronic company.
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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• Do not reuse, resterilize or reprocess the PlasmaBlade™ 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 shaft 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.
• The use of electrosurgery in the presence of internal or external active
implants is potentially hazardous.
• Interference from the electrical current can cause device malfunction.
Consult the active implant manufacturer for further information before
proceeding with the surgery.
• Direct contact with implanted leads can cause physical damage to the
leads. Exercise caution around leads associated with any active implant;
particularly those with thin insulation.
• Do not use monopolar electrosurgery on small appendages, such as in
nger 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 nger grip before use.
Do not continue to activate the device if the ball electrode tip becomes
loose as injury might occur.
Precautions
• The PlasmaBlade™ device should only be used by qualied medical
personnel possessing training 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 eect.
• 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
fastened to the surgical drape.
• Prior to initial use, ensure that all package inserts, including warnings,
cautions, instructions for use, as well as the selected 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 damaged
packages to Medtronic Advanced Energy LLC.
• Prior to use, inspect the PlasmaBlade™ device for any defects. Do not use if
insulation or connectors are damaged.
• The PlasmaBlade™ device is intended for use only with a qualied Generator.
• Prior to use, make sure that the locking mechanism is in the locked position
and unlocked only when adjusting the device shaft length.
Equipment List
• PlasmaBlade™ Compatible Generator
• Optional Generator Compatible Footswitch
• Patient Return Electrode, compatible with selected Generator
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 Generator Operator’s Manual for step-by-step instructions
regarding initial setup and preparation for surgery. The PlasmaBlade™ device
may only be used with a qualied Generator.
Before Surgery
1. Inspect the 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 PlasmaBlade™ device 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.
4. Attach the holster to the sterile drape using a clamp or tape.
The PlasmaBlade™ cable can be placed into the cutouts of the holster for
convenience.
NOTE: Ensure that the locking mechanism is in the locked position prior to
use and unlocked only when adjusting the device shaft length.
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5. For detailed instructions on the selected
Generator use, please refer to the operator’s
manual. Do not use the PlasmaBlade™ device
until reading and understanding the directions
for the selected Generator.
6. Switch on the Generator to perform the initial
setup and self-test.
7. Plug the PlasmaBlade™ device into the
Monopolar Connector of the Generator. Upon
connection, the unit will alarm if the device is not
recognized as a 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 Generator will display default power level settings for the PlasmaBlade™
device upon connection. These settings must be veried and adjusted by the
user to ensure the appropriate settings are selected. The lowest power setting
possible should be used to achieve the desired end eect.
Cable
cutouts
Electrode
cleaning slot
Table 1: PlasmaBlade™ PLUS Settings
Tissue Effect
CUT
low
hemostasis,
low collateral
damage
Level
(LCD
display)
Mode
1
2 2W
Low Cut
3 6W
Power
[W-RMS]
0.5W
4 10W
5 20W*
high
hemostasis,
higher
collateral
damage
COAG
low
hemostasis,
low collateral
damage
6
Medium Cut
7 35W
8 50W**
High Cut
9
(Blend 1)
High Cut
10
(Blend 2)
1
2
Low Coag
3
4
5
high
hemostasis,
higher
collateral
damage
6
7
High Coag
8
9
10
* 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.
**** The listed Maximum Output Voltage values pertain to device utilization with the AEX
generator. The overall Maximum Output Voltage is 2750 Vpk in accordance with device
utilization on the Pulsar II generator.
20W
25W
50W
15W
20W
25W
30W
35W***
30W
35W
40W
45W
50W
****
Maximum
Output
Voltage (Vpk)
1000
1100
950
1400
1400
500
550
550
1500
1400
1400
1400
1400
1400
1600
2400
2400
2550
2600
2600
9. If using the optional footswitch, plug the wireless receiver into the Footswitch
Connector of the selected 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
qualied Generator.
11. Monopolar devices require a Patient Return Electrode. The Generator must
detect proper Patient Return Electrode impedance before it can be active.
The operator should conrm the presence of a properly connected Patient
Return Electrode.
12. The qualied Generators have an Impedance indicator display 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 Generator Operator’s
Manual for more information.
13. Remove the electrode tip protector before activation of device.
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Manipulating the Device
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, rmly grasp the
nger grip and pull away from the
handpiece.
3. To collapse the shaft, rmly grasp
the nger grip and push into the
handpiece. Be careful not to pinch
anything between the nger grip
Collapse
(push)
Rotate
Bend
Extend
(pull)
and the shaft when collapsing.
4. If needed, use nger 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 nger grip and rotate
to the desired position.
6. The shaft and nger grip may be
locked into place at the desired
position by rotating the locking
mechanism counterclockwise. The
shaft has been locked into place
Locked
when the arrow lines up with the
horizontal bar. Do not tighten
beyond visual indicator.
7. To unlock the shaft and nger grip,
turn the locking mechanism until
Unlocked
loose.
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
Attach
Detach
ball electrode to securely attach.
5. Collapse the shaft of the
PlasmaBlade™ device or hold
the shaft to prevent it from
moving. If the shaft is extended,
it may move while you attach
the ball electrode.
Insertion line
6. Connect the tip by holding the nger grip of the ball electrode and pushing
the tip over the blade and onto the nger grip. The ball electrode should be
ush with the insertion line on the device and click into place.
7. Ensure the ball electrode is securely attached to the nger grip 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 nger grip and pull straight o.
Hold the shaft of the PlasmaBlade™ device 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.
3. The ball electrode should be oriented perpendicular to the working surface
during activation. Coagulation with the ball electrode should be achieved
with spot (vertical up and down) motion.
NOTE: The ball electrode can be used with both cut and
coagulate modes for various tissue eects. See Tables 1
and 2 for more information.
NOTE: Eschar buildup on the tip can be removed with
gauze pads or by inserting the tip into the slot at the
front of the holster and drawing the device backwards
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 eective setting.
Cleaning slot
After Surgery
1. Turn o the Generator.
2. Disconnect the PlasmaBlade™ device, Footswitch, and Patient Return
Electrode from the Generator.
3. Discard the PlasmaBlade™ device 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
patient or user injury.
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How Supplied
The PlasmaBlade™ device 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 PlasmaBlade™ device. The product is sterilized using
Ethylene Oxide (EO).
Customer Service
Please call Medtronic Customer Service at +18667779400 if you have any
device returns or questions about Medtronic’s device.
Limited Express Warranty
IF, PRIOR TO THE PRODUCT EXPIRATION DATE, THE STERILIZED DEVICE
IS FOUND TO BE INOPERABLE DURING NORMAL AND PROPER USE IN
ACCORDANCE WITH APPLICABLE INSTRUCTIONS, MEDTRONIC ADVANCED
ENERGY LLC WILL REPLACE THE PRODUCT AT NO CHARGE.
This Limited Express Warranty does not extend to a product where the
user has compromised the sterile integrity of the package or the product
is used after the product expiration date. A sterile package that has been
compromised should not be used.
Disclaimer of Implied Warranties
and Consequential Damages
MEDTRONIC ADVANCED ENERGY LLC MAKES NO OTHER
WARRANTIES WITH RESPECT TO THE PRODUCT AND
EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, AS TO MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO EVENT
SHALL MEDTRONIC ADVANCED ENERGY LLC BE LIABLE FOR
ANY INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES
OF ANY KIND. THE REMEDIES SET FORTH IN THE LIMITED
EXPRESS WARRANTY ARE THE EXCLUSIVE REMEDIES
AVAILABLE TO CUSTOMER.
Symbols
Follow Instructions for Use
Use by Date
Do Not Reuse
Do Not Resterilize
Humidity Limitation
Contains DEHP (di-2-ethyl hexyl phthalate)
Temperature Limitation
Sterilized by Ethylene Oxide
Non-Pyrogenic
Catalog Number
Lot Number
Manufacturer
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
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Medtronic Advanced Energy LLC
180 International Drive
Portsmouth, NH 03801 USA
+18667779400
medtronic.com
manuals.medtronic.com
© Copyright 2018
Medtronic Advanced Energy LLC
70-10-1453 Rev D
2018/10
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