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ÑPT000113861"Ó
PT00119046
Part No. PT00119046
Medtronic and Medtronic logo are trademarks
of Medtronic. ™* Third party brands are
trademarks of their
respective owners. All other
brands are trademarks of a Medtronic company
May be covered by U.S. Patents:
www.medtronic.com/patents
© 2016 Medtronic. All rights reserved.
Covidien llc,
15 Hampshire Street,
Mansfield, MA 02048 USA.
Product of USA (from US and foreign materials).
www.medtronic.com
REV 03/2020
Caution, consult
accompanying
documents
Do not
resterilize
Consult
instructions
for use
Single use
BiZact™
Tonsillectomy Device
Advanced Bipolar Tissue Sealer/Divider
BZ4212A
en
Instructions for Use
BZ4212A Compatible with:
FORCETRIAD SW v4.0 or Higher
VLFT10GEN SW v2.0 or Higher
VLLS10GEN SW v1.2 or Higher
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BiZact™
The BiZact™ Open Sealer/Divider is designed
for use with Covidien electrosurgical
generators that include vessel sealing
capability. Please refer to the cover page for
details on compatible generator models and
software versions. If the software version on
your generator is lower than required, contact
Covidien about software updates.
These instructions assume that the operator is
knowledgeable about correct setup and
operation of the associated Covidien
generator. Refer to the generator user’s guide
for set up information and for additional
warnings and cautions.
The instrument creates a seal by application of
radiofrequency (RF) electrosurgical energy to
blood and lymphatic vessels or tissue bundles
interposed between the jaws of the
instrument. A cutting blade within the
instrument is surgeon-activated to divide
tissue.
Maximum rated voltage: 288 V
peak
Indications for Use
The BiZact™ device is a bipolar instrument
intended for use in open surgical procedures
where ligation and division of vessels, tissue
bundles, and lymphatics is desired.
The tissue fusion function of the device can be
used on vessels (arteries and veins) and
lymphatics up to and including 3 mm diameter.
The BiZact™ device is indicated for use in open
general surgical procedures.
It is also indicated for adult, children, and
adolescent ENT procedures (3 years of age and
above), including tonsillectomy, for the ligation
and division of vessels, tissue bundles, and
lymphatics 2–3 mm away from unintended
thermally sensitive structures.
The BiZact™ device has not been shown to be
effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do not
use for these procedures.
BZ4212A Tonsillectomy Device
Advanced Bipolar
Tissue Sealer/Divider
12 mm – 12 cm
Operation and Storage
Ambient temperature
Range
10°C to 40°C (50°F to
104°F)
Relative humidity 15% to 90% non-
condensing
Transport
Ambient temperature
Range
-30°C to 60°C (-22°F to
140°F)
Relative humidity 15% to 90% non-
condensing
Not made with natural rubber latex
Do not use if package is opened or
damaged
Warning
This product cannot be adequately cleaned
and/or sterilized by the user in order to
facilitate safe reuse, and is therefore
intended for single use. Attempts to clean or
sterilize these devices without appropriate
regulatory authorization may result in bioincompatibility, infection, or product failure
risks to the patient.
This instrument is intended for use only with
the Covidien equipment listed on the cover
of this document. Use of this instrument with
other generators may not result in the
desired tissue effect, may result in injury to
the patient or surgical team, or may cause
damage to the instrument.
Do not use the BiZact™ system unless
properly trained to use it in the specific
procedure being undertaken. Use of this
equipment without such training may result
in serious unintended patient injury.
Use the system with caution in the presence
of internal or external pacemakers or other
implanted devices. Interference produced
by electrosurgical equipment can cause a
pacemaker or other device to enter an
unsafe mode or permanently damage the
device. Consult the device manufacturer or
responsible hospital department for further
information when use is planned in patients
with implanted medical devices.
While every attempt has been made to
reduce patient and user risks, all surgeries
using this device carry some residual risk,
even when used by trained physicians.
Contact between an active instrument
electrode and any metal objects (hemostats,
staples, clips, retractors, etc.) may increase
current flow and may result in unintended
surgical effects, such as an effect at an
unintended site or insufficient energy
deposition.
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After Surgery
Discard the instrument after use according to
the facility’s policy for biohazards and sharps.
Do not resterilize.
Pre-Clinical Studies
Product performance of the device was
established in a chronic in-vivo porcine model.
The results showed that no animals studied
experienced any hemostatic complications
related to the device during the 21-day survival
period. A variety of tissue types and vessels was
evaluated to demonstrate effective sealing in
arteries and veins up to and including 3 mm.
California Proposition 65 Statement
For information regarding California Proposition 65, please refer to www.covidien.com/caprop65.
Reasons for alert
Too little tissue between the jaws – The user is grasping thin tissue or not enough
tissue; open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If
necessary, increase the thickness of tissue that is grasped and reactivate the seal cycle.
Too much tissue between the jaws – The user is grasping too much tissue; open the
jaws, reduce the amount of tissue that is grasped, and reactivate the seal cycle.
Activating on a metal object – Avoid grasping objects, such as staples, clips, or
encapsulated sutures in the jaws of the instrument.
Dirty jaws – Use a wet gauze pad to clean surfaces and edges of instrument jaws.
Excess fluids in the surgical field – Minimize or remove excess fluids from around the
instrument jaws.
Activation switch released before seal complete tone – The footswitch or activation
button was released before the seal cycle was complete.
Maximum seal cycle time has been reached – The system needs more time and energy
to complete the seal cycle.
Troubleshooting Information
Notice
There is no animal data qualified to predict
the effectiveness of this device in sealing
vessels containing atherosclerotic plaque.
In Vivo Vessel Performance (Chronic)
Vessel type Tissue/Vessel name Vessel size range
A/V bundle Omentum up to 1.0 mm
Gastrosplenic 3.0 mm – 4.0 mm arteries within bundles
Ovarian Pedicle 4.0 mm – 5.0 mm
Broad Ligament 1.0 mm – 3.0 mm
Short Gastric 2.5 mm – 5.0 mm
Isolated vessel
(artery, vein)
Splenic 1.5 mm – 4.0 mm
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4. To divide tissue, maintain steady pressure
on the lever and pull the cutting trigger
until a hard stop is reached. Then release
the cutting trigger to allow the blade to
retract.
5. Open the jaws to release tissue.
6. To seal adjacent tissue, overlap the edge of
the existing seal. The second seal should be
distal to the first seal to increase seal
margin.
Note: If both the activation button and the
footswitch pedal are activated during the
same seal cycle, the vessel sealing system
delivers energy from the activation source
it detects first.
Cutting Tissue
1. To divide tissue, maintain steady pressure
on the lever and pull the cutting trigger
until a hard stop is reached. Then release
the cutting trigger to allow the cutting
blade to retract.
2. Open the jaws to release tissue.
Cleaning the Instrument During Use
1. Ensure the instrument is not plugged into
the generator.
2. Wipe jaw surfaces and edges with a sterile,
wet gauze pad as needed.
Troubleshooting
Warning
Energy-based devices, such as ES pencils or
ultrasonic scalpels that are associated with
thermal spread, should not be used to
transect seals and sealed tissue.
Notice
Failure to maintain steady pressure on the
lever while cutting could result in
inadvertent reactivation of energy.
Warning
Inspect the instrument jaws prior to cleaning
to ensure the cutting blade is not deployed.
Do not activate the instrument or cutting
trigger while cleaning the jaws. Injury to
operating room personnel may result.
Notice
Do not attempt to clean the instrument jaws
by activating the instrument on wet gauze.
Product damage may occur.
Remove any embedded tissue from blade
track and jaw hinge area.
Do not clean the instrument jaws with a
scratch pad or other abrasives.
Troubleshooting Information
The following is a list of troubleshooting suggestions for situations encountered when using the instrument
with compatible Covidien vessel sealing generators. For details on specific situations, refer to the
corresponding generator user’s guide or the generator quick reference guide.
Alert situations
When an alert condition occurs, energy delivery stops, the generator produces a
sequence of pulsed tones, and an alert will be displayed on the generator. Do not cut the
vessel. The user should inspect the seal site and instrument before proceeding. After the
alert condition has been corrected, energy delivery will be immediately available.
Troubleshooting
steps
1) Release the footswitch pedal or activation button, if still engaged.
2) Open the instrument jaws and inspect for a successful seal.
3) Follow the suggested corrective actions on the generator screen, the generator quick
reference card, or in the generator user’s guide.
4) If possible, reposition the instrument and regrasp tissue in a location that overlaps the
previous seal, then reactivate the seal cycle.
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BZ4212A BiZact™ Open Sealer/Divider
Jaws (gray)
ཱLever (gray)
ིActivation button (blue)
ཱིCutting trigger (gray)
ུHandle (white)
ཱུConnector (blue and white)
ྲྀCable (blue)
ཷOuter shaft (metallic)
Setup
1
8
2
5
7
6
4
3
Warning
The safe and effective use of RF energy
depends on many factors solely under the
control of the operator. There is no
substitute for properly trained and vigilant
personnel. It is important that the operating
instructions supplied with this or any other
medical equipment be read, understood,
and followed.
Use only with HF surgical mode output
settings resulting in a peak output voltage
not greater than the rated accessory.
Caution
Use caution during surgical cases in which
patients exhibit certain types of vascular
pathology (atherosclerosis, aneurysmal
vessels, etc.). For best results, apply the seal
to unaffected vasculature.
Warning
Electric Shock Hazard – Do not connect wet
accessories to the BiZact™ system.
Position instrument cords to avoid contact
with the patient or other cords. Do not wrap
cords around metal objects. This may induce
currents that could lead to shocks, fires, or
injury to the patient or surgical team.
Examine all BiZact™ system and instrument
connections before using. Improper
connections may result in arcing, sparks,
accessory malfunction, or unintended
surgical effects.
Confirm proper BiZact™ system settings
before proceeding with surgery.
Do not bend instrument shaft. If the
instrument shaft is visibly bent, discard and
replace the instrument. A bent shaft may
prevent the instrument from sealing or
cutting properly.
Inspect the instrument and cords for breaks,
cracks, nicks, or other damage before use.
Failure to observe this caution may result in
injury or electrical shock to the patient or
surgical team or cause damage to the
instrument. If damaged, do not use.
Do not use in the presence of flammable
anesthetics or oxidizing gases, such as
nitrous oxide (N2O) and oxygen, or in close
proximity to volatile solvents (such as ether
or alcohol) as explosion may occur.
Because of concerns about the carcinogenic
and infectious potential of electrosurgical
by-products (such as tissue smoke plume
and aerosols), protective eye wear, filtration
masks, and effective smoke evacuation
equipment should be used.
Connect adapters and accessories to the
electrosurgical unit only when the unit is off
or in standby mode. Failure to do so may
result in injury or electrical shock to the
patient or operating personnel.
Warning
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1. Open the pouch, remove the device from
the pouch and the card.
2. Insert the instrument connector (6) of the
BiZact™ device into the LigaSure™
instrument port of the generator. Refer to
the generator user’s guide for additional set
up information.
During Surgery
The BiZact™ instrument can be used during
surgery both to manipulate and dissect tissue,
and to seal and cut vessels and tissue bundles.
Instructions for use of the instrument during a
procedure are provided in this section.
Tissue Manipulation and Dissection
The instrument can be used to manipulate and
dissect tissue with the jaws either open or
closed.
Sealing and Cutting Vessels and Tissue
Bundles
Caution
The performance of this single use device
has been tested according to the expected
conditions of a single surgical procedure.
Subjecting the device to process steps, tools,
and/or chemicals commonly used by thirdparty reprocessors may negatively affect its
performance.
Inspect packaging for damage. If damaged,
do not use.
Warning
Avoid placing fingers between the jaws or
the lever (2) and the handle. Injury to the
user may result.
Use caution when handling the instrument
between uses to avoid accidental activation
of the BiZact™ system. Do not place the
instrument on the patient or drapes when
not in use.
Keep the cable free from between the jaws
or the lever and the handle of the
instrument.
Fire Hazard – Do not place instruments near
or in contact with flammable materials (such
as gauze, surgical drapes, or flammable
gases). Instruments that are activated or hot
from use may cause a fire. When not using
instruments, place them in a clean, dry,
highly visible area not in contact with the
patient. Inadvertent contact with the patient
may result in burns.
Warning
Prior to sealing or manipulating tissue,
ensure that the cutting blade is not exposed.
Do not use this instrument on vessels larger
than 3 mm in diameter.
Do not place the vessel and/or tissue in the
jaw hinge. Place the vessel and/or tissue in
the center of the jaws.
Do not divide tissue before the seal cycle is
complete as this may result in improper
sealing.
Prior to cutting, inspect the vessel or tissue
to ensure proper sealing.
Do not pull the cutting trigger while the jaws
are open as injury to the patient or surgical
team may occur.
Keep the external surface of the instrument
jaws away from adjacent tissue while
activating the BiZact™ system or unintended
injury may result.
Conductive fluids (e.g., blood or saline) in
direct contact with or in close proximity to
the instrument may carry electrical current
or heat, which may cause unintended burns
to the patient. Aspirate fluid from around the
instrument jaws before activating the
instrument.
During a seal cycle, energy is applied to the
tissue between the instrument jaws. This
energy may cause water to be converted
into steam. The thermal energy of steam
may cause unintended injury to tissues in
close proximity to the jaws. Care should be
taken in surgical procedures occurring in
confined spaces in anticipation of this
possibility.
Do not attempt to seal or cut over clips or
staples as incomplete seals/damage to the
cutting blade will occur. Contact between an
active electrode and any metal objects may
result in alternate site burns or incomplete
seals.
If the seal-cycle-complete tone has not
sounded, an optimal seal may not have been
reached. Reactivate RF energy until a sealcycle-complete tone is heard.
Use caution when grasping, manipulating,
sealing, and dividing large tissue bundles.
The surfaces of the jaws and distal shaft may
remain hot enough to cause burns after the
RF current is deactivated.
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Hand Activation
1. Ensure hand-activation is enabled on the
appropriate port. Refer to the generator
user’s guide if needed.
2. Grasp the intended vessel and/or tissue in
the center of the jaws.
3. Close the lever until you hear or feel the
click. At the click, energy is delivered.
A continuous tone sounds to indicate the
activation of RF energy. When the
activation cycle is complete, a twopulsed seal-cycle-complete tone sounds
and (RF) output ceases.
4. To divide tissue, maintain steady pressure
on the lever and pull the cutting trigger (4)
until a hard stop is reached. Then release
the cutting trigger to allow the blade to
retract.
5. Open the jaws to release tissue.
6. To seal adjacent tissue, overlap the edge of
the existing seal. The second seal should be
distal to the first seal to increase seal
margin.
Footswitch Activation
A footswitch can be used instead of the handactivation button (3). Ensure that the LS0300
footswitch is connected to the footswitch
receptacle. Refer to the generator user’s guide
for additional information.
1. Grasp the intended vessel and/or tissue in
the center of the jaws.
2. Press and hold the lever to the click to
ensure appropriate pressure on the
grasped tissue.
3. Press and hold the footswitch pedal to
activate energy.
A continuous tone sounds to indicate the
activation of RF energy. When the
activation cycle is complete, a twopulsed seal-cycle-complete tone sounds
and (RF) output ceases.
Inadvertent activation or movement of the
activated instrument outside of the field of
vision may result in injury to the patient or
surgical team.
Do not activate the energy system in an
open-circuit condition. Activate the energy
system only when the instrument is in direct
contact with the target tissue to lessen the
possibility of unintended burns.
Do not activate the instrument while
instrument jaws are in contact with, or in
close proximity to, other metal instruments
as localized burns to the patient or physician
may occur.
If the cutting trigger does not automatically
return to position, open the lever to
manually return the cutting trigger.
Eliminate tension on the tissue when sealing
and cutting to ensure proper function and
reduce bleeding.
Caution
When intending only to grasp or manipulate
tissue, ensure pressure from the lever to the
button does not activate energy delivery.
During tonsillectomy procedures, stay in the
correct surgical plane to prevent damage to
critical structures such as the
glossopharyngeal nerve.
Keep the instrument jaws clean. Build-up of
eschar may reduce the seal and/or cutting
effectiveness. Do not activate the instrument
while cleaning. Wipe jaw surfaces and edges
with a wet gauze pad as needed.
Do not overfill the jaws of the instrument
with tissue, as this may reduce device
performance.
Notice
Closing the lever until it clicks activates
energy delivery if hand-activation is being
used.
Warning
Notice
Failure to maintain steady pressure on the
lever while cutting could result in
inadvertent reactivation of energy.
Important
The LS10 generator does not support
footswitch activation.
Warning
Activating energy delivery with a footswitch
when the hand-activation button is not fully
depressed may result in improper sealing
and increase thermal spread to tissue
outside the surgical site.
Notice
If the footswitch is activated with the jaws
open, the generator will provide a regrasp
alarm indicating the user should regrasp the
tissue.
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