DCO-1318
Effective Date: 01-SEP-2021
LBL 6028 Rev. G
Page 12 of 23
7.
To perform soft tissue resection, bone burring, or ablation, position
the tip of the device adjacent to the tissue and press the activate
button/pedal.
8.
If bleeding occurs, position the electrode adjacent to the bleeding
tissue and activate the blue pedal on the footwitch or blue button on
the Handpiece.
9.
The handpiece joystick can be used to adjust rotational speed, set
pressure, suction level, and/or RF power level depending on the
attached device, mode, and joystick setting. See section 15.2-15.3
for more detail.
10.
To change the mode, the left and right black footswitch corner
buttons can be pressed, or the mode button on the handswitch can
be used.
11.
To change the coagulation power level, press the coag power level
button next to the settings button in the bottom left of controller GUI.
12.
To activate suction at any time, press the black suction pedal on the
right-hand side of the footswitch or hold the mode button on the
handpiece.
12.
DISASSEMBLY
1.
Remove the Tricera Device from the cavity.
2.
Applies to Veriflow FMA set R-10003 only: Before the removal of
the arthroscope from the cavity, turn off saline pump by pressing the
flow button on the footswitch or the stop button on the GUI screen.
3.
Remove the red suction tubing connector from the Tricera
Handpiece.
4.
Remove the Tricera Device from the shaver handpiece. Dispose of
the Tricera Device following standard hospital practices.
Steps 5-7 apply to Veriflow FMA set R-10003 only
5.
Disconnect the inflow tube from the Arthroscope/Sheath.
6.
Remove the saline bag from the saline pole and bring to a height
lower than the controller.
7.
Disconnect the saline spikes.
8.
Press the unlock button on the controller screen to remove the FMA
cassette. The FMA cassette can now be disposed following
standard hospital practices.
9.
Disconnect the Tricera Handpiece from the Tricera Controller.
10.
Follow the cleaning and sterilization procedures for the Tricera
Handpiece per its instructions for use.
13.
CLEANING
13.1.
Cleaning Precautions
1.
Follow universal precautions for protective apparel when handling
and cleaning contaminated instruments.
2.
Clean instruments within 30 minutes after use to minimize the
potential of blood and debris drying prior to cleaning.
3.
After use, Tricera Devices may be a potential biohazard and should
be handled in accordance with acceptable medical practice and
applicable local and national requirements.
4.
Dispose of all non-reusable tubing sets, irrigation tips and Tricera
Devices properly after use.
5.
DO NOT lubricate any handpieces.
6.
DO NOT immerse the controller, footswitch or attachments.
7.
Clean the controller, footswitch and footswitch cable per the
Cleaning Instructions in Section 13.2.
8.
Clean the handpieces per the Cleaning Instructions in the
Instructions for use for the Tricera Handpiece.
9.
Never clean handpieces with bleach, chlorine-based detergents,
liquid or chemical disinfectants, or any products containing sodium
hydroxide. They will degrade the coatings.
10.
Never clean equipment in an ultrasonic cleaner or a combination
washer/sterilizer.
11.
For aluminum surfaces, a neutral-pH agent should be used. To
prevent corrosion, avoid contact with strong alkaline solutions (pH
over 10.5) or agents containing iodine or chlorine.
13.2.
Tricera Controller and Footswitch Cleaning Instructions
Follow this procedure after each operation to clean the Controller and
Footswitch:
1.
Disconnect the Controller from the electrical source.
2.
Wipe the controller, footswitch and footswitch cable with a clean,
soft cloth dampened with a mild, pH-balanced detergent. Prolonged
exposure to any corrosive solvents or disinfectants should be
avoided.
a.
Thoroughly clean the tubing cassette roller area on the
controller. Ensure the rollers are free of all debris.
b.
Be sure to wipe the underside of the footswitch to ensure no
particles have attached themselves.
3.
Wipe equipment again with distilled or sterilized water to prevent
metal discoloration.
13.3.
Tricera Handpiece Cleaning Instructions
See the Instructions for use for the Tricera Handpiece
14.
STORAGE
14.1.
Tricera Controller (See Appendix A)
14.1.1.
Fluid Management Accessories and Tricera Devices
The unused Tricera Devices and Fluid Management
Accessories should be stored at room temperature,
away from moisture and direct heat.
14.2.
Tricera Handpiece
The Tricera Handpiece should be stored at room temperature,
away from moisture and direct heat.
15.
TRICERA CONTROLLER SETTINGS,
MAINTENANCE, TROUBLESHOOTING AND
REPAIR
15.1.
Adjusting Volume
Adjusting the volume on the controller is accessed through the options
menu:
Figure 26
Options Menu
