DCO-1318
Effective Date: 01-SEP-2021
LBL 6028 Rev. G
Page 5 of 23
•
Use only normal saline (sodium chloride 0.9% w/v; 150mmol/l) or
Ringer’s lactate irrigation solution. The performance of the system
can be adversely affected by use of any other solution.
•
DO NOT pinch, step on, kink or otherwise occlude the tubing set.
Tubing restrictions can result in high pressure or poor device
performance.
•
Continuous, extended RF energy output may cause the Tricera
Controller to overheat. If this occurs, the Controller must be
allowed to cool down before further use.
Shaver Blade/Burr and RF Probe Precautions
•
Excessive force on the shaver blade/burr and RF probe tip does
not improve the device’s performance and may increase the risk of
tissue and/or device damage.
•
DO NOT allow the tip of the shaver blades/burrs and RF probes to
touch any hard object. If such contact does occur, inspect the tip.
If there are cracks, fractures, or if there is any other reason to
suspect the tip is damaged, replace the device immediately.
•
Any monitoring electrodes are recommended to be placed as far
as possible from the Tricera devices when high frequency surgical
equipment and physiological monitoring equipment are used
simultaneously on the same patient. Monitoring systems
incorporating high frequency current-limiting devices are
recommended for use.
•
Excessive force applied during insertion or removal of the shaver
blades/burrs and RF probes may result in device damage or tissue
injury.
•
Insertion and removal of the shaver blades/burrs and RF probes
should always be under direct visualization.
•
DO NOT activate the shaver blades/burrs and RF probes unless
the tip is immersed in a saline environment. Electrodes may arc if
activated in air, damaging the device.
•
DO NOT use the shaver blades/burrs and RF probes as a tool for
mechanical displacement of tissue or bone or use the devices as a
prying or scrubbing tool, as this may result in damage to the tip of
the devices.
7.
ENVIRONMENTAL PROTECTION
•
Observe all national waste management regulations.
•
DO NOT dispose of Waste Electrical and Electronic Equipment
(WEEE) as unsorted municipal waste.
•
Follow local governing ordinances and hospital practice regarding
the disposal of the Probe/Tricera Devices and Fluid Management
Accessories – Disposable Devices.
•
The Controller contains an electronic printed circuit assembly. At
the end of the useful life of the equipment, it should be disposed of
in accordance with any applicable national or institutional policy
relating to obsolete electronic equipment.
8.
HOW SUPPLIED
8.1.
Controller with Integrated Fluid Management
The Controller is supplied non-sterile and is intended for reuse as a
capital equipment in an orthopaedic or arthroscopic surgical
environment.
The shipping box contains:
•
One (1) Controller
•
One (1) Footswitch
•
One (1) Detachable 10 ft. Hospital Grade Power Cord
•
One (1) Tricera System Instructions Manual
8.2.
Fluid Management Accessories (All Models)
The Fluid Management Accessories are supplied sterile and
are intended for single-patient use only. DO NOT re-sterilize
or reuse. After each patient use, dispose of properly.
The shelf box contains:
•
One (1) Fluid Management Accessories
•
One (1) Tricera System Package Insert
8.3.
Shaver Blade/Burr and RF Probe (All Models)
The shaver blades/burrs and RF probes are supplied sterile
and are intended for single patient use only. DO NOT re-
sterilize or reuse. After each patient use, dispose of properly.
The shelf box contains:
•
Four (4) Shaver Blade/Burr or RF Probe
•
One (1) Tricera System Package Insert
8.4.
Tricera Handpieces (All Models)
The Tricera Handpiece is supplied non-sterile and is intended
for reuse. It must be cleaned and sterilized before the first
use. Prior to each subsequent use, it must be cleaned and
sterilized.
The shipping box contains:
•
One (1) Tricera Handpiece
•
One (1) Tricera Handpiece Instructions for Use
(including cleaning and sterilization instructions)
•
Three (3) Cleaning Brushes
o
One (1) Tricera Device Cavity Brush
o
One (1) Motor Shaft Brush
o
One (1) Fluid Channel Brush
