Medtronic BZ4212A Instructions for Use

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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
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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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