Zimmer Biomet TRICERA SYSTEM Instrucciones De Uso página 11

Figure 25 (Inflow Pump Active)
4. To introduce fluid into the joint, insert the arthroscope into the joint cavity following standard arthroscopic
techniques and activate inflow.
5. Insert the Tricera Device into the joint following standard arthroscopic techniques.
6. Activation of the Tricera Device occurs by pressing the Activate (yellow) pedal on the footswitch or the
Activate (yellow) button on the Tricera Handpiece.
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 Annexe 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:
DCO-1394
Effective Date: 12-JAN-2022
Options Menu
Adjust the volume by pressing the + or – symbol.
15.2. Latching Handpiece Button ON and OFF
When this feature is on, the activate (yellow) button on the Handpiece becomes a toggle switch when using
mechanical (non-RF) modes. When pressed, non-RF modes (e.g. oscillate, bone burr) will remain active until any
button on the handpiece or footswitch is pressed. To toggle the button latching mode, enter settings and then enter
the temporary tab and press the "Handpiece Button Latch" on/off button.
15.3. Handpiece Joystick Toggle
15.3.1. If desired, the handpiece joystick functionality can be disabled by pressing the
"Handpiece Joystick" button. This setting is shown in Figure 28 below.
15.3.2. If desired, the handpiece joystick functionality can be set to adjust the suction with the
up and down directional on the joystick, and the pressure with the left and right
directional on the joystick. This setting is selected in the options menu in Figure 29
below.
15.3.3. If desired, the handpiece joystick functionality can be set to adjust the suction with the
up and down directional on the joystick, and the speed/power with the left and right
directional on the joystick (RF modes will allow RF adjustment, while mechanical modes
allow speed adjustment). This setting is selected in the options menu in Figure 29
below.
Figure 26
Figure 27
Figure 28
Figure 29
LBL 6028 Rev. K
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