DCO-1318
Effective Date: 01-SEP-2021
LBL 6028 Rev. G
Page 2 of 23
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
o
Tricera Footswitch
•
Fluid Management Accessories (All Models)
•
Tricera Handpieces (All Models)
•
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:
o
Inflow tubing with a pressure diaphragm (Veriflow model
only)
o
Outflow tubing (All Models)
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 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.
