Publicidad
Idiomas disponibles
Idiomas disponibles
2.
DEVICE DESCRIPTION
The Tricera System is an arthroscopic surgery platform designed for use in orthopedic and arthroscopic procedures
for the fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist, and hip. The Tricera System provides
abrasion, resection, debridement, and removal of bone; removal, ablation, and coagulation of soft tissue; as well as
hemostasis of blood vessels. Examples of uses of the product include resection of torn knee cartilage, subacromial
decompression, and resection of synovial tissue in other joints.
The Tricera System consists of the following components:
•
Tricera Controller
Tricera Footswitch
o
•
Fluid Management Accessories (All Models)
•
Tricera Handpieces (All Models)
•
Tricera Shaver Blades/Burrs and RF Probes (All Models)
The Tricera Controller performs fluid management control, shaver control, and RF control. The Tricera Controller
provides power to the Tricera Handpiece for arthroscopic resection and bone burring. The Tricera Controller pumps
operate with the Veriflow Fluid Management Accessories to deliver fluid under pressure control to the joint. The
Tricera Controller delivers RF through the Tricera handpiece to the disposable RF devices. The RF is used for the
resection, ablation, and coagulation of soft tissue within the joint.
The Tricera Footswitch includes the following features:
•
Activate Pedal
•
Coagulation Pedal
•
Flush Pedal
•
Inflow Toggle
•
Cycle Forward Mode Button
•
Cycle Backward Mode Button
The Veriflow/Exoflow Fluid Management Accessories (FMA) is a single-patient use only device, which consists of
the following:
•
The Cassette that houses:
Inflow tubing with a pressure diaphragm (Veriflow model only)
o
Outflow tubing (All Models)
o
The Tricera Handpiece is a reusable, electrically powered, hand-held surgical instrument that uses interchangeable
devices to abrade and remove bone and accomplish the debridement of soft tissue. The Tricera handpiece has RF
contacts which connect to the disposable devices to deliver RF to the tissue for resection, ablation, and coagulation
of soft tissue within the joint. The Tricera handpiece features: hand switches for controlling disposable device
activation, modes, settings, speed, suction adjustment and flush; and a suction irrigation port for removing irrigant
from the operating site.
The Tricera Shaver Blades/Burrs provide abrasion, resection, and debridement of bone and soft tissue. The Shaver
Blades/Burrs and RF Probes provide ablation and coagulation of soft tissue, as well as hemostasis of blood vessels.
3.
INDICATIONS FOR USE
The Tricera System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System
of the Tricera Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist
and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of
the Tricera Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver
blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver
blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial
decompression, and resection of synovial tissue in other joints.
Contraindications: The electrosurgical probe should not be used in procedures where a nonconductive irrigant is
used or with patients having cardiac pacemakers or other electronic implants.
4.
CONTRAINDICATIONS
The Tricera System contains many metal components. Therefore, it is MRI unsafe. DO NOT use the Tricera System
in conjunction with MRI, CT or RFID.
5.
WARNINGS
A warning contains critical information regarding serious adverse reactions and potential safety hazards that can
occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a
Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff.
Tricera System General Warnings
WARNING: The Tricera System is only intended for use as outlined in Section 3, Indications for Use.
WARNING: Before using the Tricera System, please review all available product information carefully!
WARNING: The Tricera System should only be used by physicians trained in arthroscopic procedures. It is the
responsibility of the user to be familiar with indications, contraindications, potential complications, and risks
associated with the arthroscopic procedures being performed.
WARNING: DO NOT open the controller chassis, as this may void the warranty. There are no user-serviceable parts
inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or
other risks.
WARNING: DO NOT attach, insert or remove accessories or attachments while the handpiece is operating.
WARNING: All accessories of the fluid management are one-time use ONLY. DO NOT re-sterilize or reuse. After
use, dispose of properly.
WARNING: Disposable shaver blades/burrs and RF probes are provided sterile and for single-use ONLY. DO NOT
re-sterilize or reuse. After use, dispose of properly.
WARNING: The ability to effectively clean and re-sterilize single-use devices has not been established and
subsequent re-use may adversely affect the performance, safety and/or sterility of the device.
WARNING: After use, the fluid management accessories and shaver blades/burrs and RF probes may be a
potential biohazard and should be handled in accordance with acceptable medical practice and applicable local and
national requirements.
WARNING: DO NOT use equipment if, upon receipt, package is opened, damaged, or shows any signs of
tampering.
WARNING: DO NOT use a Tricera device if it shows any signs of damage.
WARNING: When using blades/burrs and RF probes, avoid excessive lateral force as damage or breakage may occur.
WARNING: DO NOT use sterile devices after the stated expiration date.
WARNING: Continually check all handpieces and attachments for overheating. If overheating
is sensed,
immediately discontinue use and return equipment for service. Overheating can lead to patient injury (burn).
Refer to Tricera Handpiece Instructions for Use LBL 6059 for additional warnings and precautions for the
Tricera Handpieces (All Models).
WARNING: The service intervals are required to keep the handpieces at their optimum operating performance.
Failure to follow the recommended PM schedule can cause devices to overheat which may lead to patient injury
(burn). Refer to Tricera Handpiece Instructions for Use LBL 6059 for additional warnings and precautions for the use
of the Tricera Handpieces (All Models).
WARNING: DANGER: DO NOT operate the Tricera System in close proximity to volatile solvents such as methanol
or alcohol, or in the presence of flammable anesthetics, as explosion may occur.
WARNING: DO NOT connect the Tricera FMA to another fluid management system, shaver handpiece, or controller.
Use with another fluid management system, shaver handpiece or controller may result in failure of the device to
operate or lead to patient or physician injury.
WARNING: Equipment grounding is vital to ensure safe operation. Plug the power cord into a properly earthed
mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in
this manual. DO NOT use plug adapters or extension cords; such devices defeat the safety ground and could cause
injury.
Fluid Management Warnings
WARNING: Place the pump at the same height or lower than the joint to ensure accurate pressure readings.
DCO-1394
Effective Date: 12-JAN-2022
WARNING: Perform the endoscope calibration at the same height as the joint to ensure accurate pressure readings.
Ensure that the endoscope stopcock connected to the inflow tubing is completely open during the calibration
procedure and that any other stopcock is closed.
WARNING: Using fluid to distend the joint carries the possibility of fluid extravasation into the surrounding tissue.
Select the optimal pressure based on the patient profile, including but not limited to: blood pressure, height, weight,
age, and tissue quality. Recommended pressure settings are included in this manual; however, these are only
suggestions, and each surgery and each patient may require different parameters.
WARNING: The fluid pump is only intended for use with flexible containers for the inflow fluid. Do not use glass
containers as they might implode due to the vacuum being generated inside of the container.
WARNING: For Veriflow inflow only, DO NOT partially open or close the stopcocks on the inflow sheath as this may
lead to overpressure or underpressure within the joint. The inflow stopcock should be completely open or completely
closed.
WARNING: Keep the pump dry. If liquid has accidentally leaked into the pump from the Fluid Management
Accessories cassette, change the cassette.
WARNING: Failure of the system may result in an unintended increase or decrease in flow and/or pressure.
Carefully monitor the joint when using the system.
Known Risks Associated with use of Electrosurgical Devices:
1.
EMC issues – interference causes device failure, interference causes other devices to fail, RF
interferes with pacemaker, defibrillator
2.
Electrical safety issues – shock, burn – device/controller overheats, incorrect power source used,
fluid enters the controller, use of incorrect power source, arcing.
3.
Explosion/fire if operated near volatile solvents
4.
Tissue damaged during coagulation/resection
Shaver Blade/Burr and RF Probe Warnings
WARNING: DO NOT operate the Tricera Devices without clear visualization. The device should be in the field of
view while it is operating. If visualization is lost at any point during the procedure, the device's function must be
stopped immediately.
WARNING: Do NOT touch the device tip at any time during the application of motor or RF power.
WARNING: Do NOT insert or withdraw the device during application of power.
WARNING: Do NOT activate the device while in contact with metal objects and/or instruments as unintended tissue
or device damage can occur.
WARNING: During extended periods of activation the shaft of the device may become hot. Pause occasionally to
keep the shaft cool.
WARNING: Ensure that adequate inflow and outflow of conductive irrigant is maintained at all times during RF
probe use or else irrigant may overheat and damage surrounding tissue.
6.
PRECAUTIONS
A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective
use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in
damage to the equipment.
Tricera System General Precautions
•
Federal (US) law restricts this device to sale by or on the order of a physician.
•
DO NOT expose the Tricera Controller to moisture, operate in wet areas, or place liquids on or above the
controller.
•
Tricera handpieces are factory sealed. DO NOT disassemble or lubricate, as this may void the warranty.
There are no user-serviceable parts inside.
•
Use only associated Tricera attachments and accessories as defined within the descriptions of each
attachment.
•
After each use, thoroughly clean the controller, footswitch, and handpieces.
•
DO NOT use the shaver blades/burrs and RF probes or the Fluid Management Accessories if the sterile
barrier or sterility is compromised prior to or during the procedure. Failure to maintain sterile technique in
the operating room could result in the transfer of microorganisms into the body tissues.
•
The shaver blades/burrs and RF probes and Fluid Management Accessories are intended for single patient
use only. Discard these Tricera disposable devices after each patient use.
•
DO NOT re-use or re-sterilize the shaver blades/burrs and RF probes and Fluid Management Accessories.
Use of re-processed, single-use device(s) may result in patient or physician injury.
•
Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately
for service.
•
Prior to each use, perform the following:
Inspect all equipment for proper operation.
o
Ensure all attachments and accessories are correctly and completely attached to the Tricera
o
Handpiece.
Perform the required Performance Tests for each associated handpiece (See LBL 6059 Handpiece
o
IFU).
•
DO NOT excessively bend or kink the instrument handpiece cord or power cord. Always inspect cords for
signs of excessive wear or damage, or bent, broken or missing pins within the connector(s). If any wear or
damage is found, discontinue use and replace immediately.
•
DO NOT handle the controller, handpieces or footswitch by the cord. DO NOT pull on the cord to remove it
from the handpiece or controller.
•
Running the shaver blades/burrs and RF probes without fluid flow (dry) may cause damage to the device.
•
DO NOT stall handpieces, damage can occur.
•
Always inspect for bent, dull or damaged blades/burrs and RF probes before each use. DO NOT attempt to
straighten or sharpen. DO NOT use if damaged. After use, dispose of properly.
•
Direct contact of the rotating cutting edge of shaver blades/burrs with metallic surfaces and/or other hard
surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices. If contact
does occur, shaver blades/burrs can break, seize, or shed particles. Shaver blades/burrs should be
examined for damage and replaced if necessary.
•
DO NOT apply excessive loading on the shaver blade/burr or RF probe. Performance is not increased with
force. Excessive force or using devices as a lever can cause damage to the device including permanent
deformation, wear and seizure.
•
Use Tricera System with caution in the presence of any active implantable or body worn medical devices
such as internal or external pacemakers or neurostimulators. Interference produced by the use of
electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the
pacemaker effect entirely. The output of the Tricera device might also affect other types of active devices
such as implanted neurostimulator devices. Consult the active implantable device manufacturer (for
implanted pacemakers and ICDs the hospital cardiology department might also be helpful) for further
information when use of electrosurgical devices is planned in patients with active implantable devices such
as cardiac pacemakers.
•
If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD manufacturer for
instructions before performing ablation, coagulation, or other electrosurgery. Electrosurgery or
tissue coagulation may cause multiple activations of ICDs.
LBL 6028 Rev. K
Page 4 of 306
Publicidad
