ÑPT000113861"Ó
PT00119046
Part No. PT00119046
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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
2
en
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.
7
en
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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