Zimmer Biomet Tricera Instruction Manual Download Page 11

 

DCO-1318 

 

Effective Date: 01-SEP-2021

 

LBL 6028 Rev. G 

Page 11 of 23 

 

 

Figure 20 

Connect a Shaver Blade/Probe 

18. Remove the Tricera Device from the sterile packaging and place 

onto the sterile table 

 

Figure 21 

19. Connect the Tricera Device to the Tricera Handpiece by inserting 

the Tricera Device into the open end of the Tricera handpiece 
20. Align the Tricera Device/probe tabs with the slots on the Tricera 

handpiece and ensure that the tabs snap into place in the Tricera 

Handpiece slots. 

 

Figure 22 

 

Figure 23 

The controller will detect that the device is connected and emit an 

audible tone. 

11. 

SYSTEM OPERATION 

 

 

NOTE: steps 1-4 apply to Veriflow FMA set R-10003 only. 

1.

 

Set the desired joint cavity pressure on the touch screen of the 

Controller by pressing the plus or minus buttons below the cavity 

pressure ring.  The cavity pressure can be adjusted at any time 

during the procedure.   

2.

 

The Tricera Controller will set the following default pressure set 

point based on the initial joint selection. 

Knee: 45mmHg 

Shoulder: 50mmHg 

Hip: 50mmHg 

Small Joint: 35mmHg 

Default pressure settings are only suggestions, and each surgery and 

patient may require different parameters. 
3.

 

To activate the inflow, press the top center button on the footswitch 

or the play button between the plus and minus buttons for the set 

pressure on the GUI screen.  When the pump is activated, a blue 

dot animation will be active.  When the pump is deactivated, no 

animation will be visible. 

 

Figure 24 (Inflow Pump Inactive) 

 

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.  

Summary of Contents for Tricera

Page 1: ...15 Appendix C Abbreviations 15 Appendix D Tones 15 Appendix E Troubleshooting 16 Appendix F Essential Performance Power Curve 18 Appendix G EMC Tables 19 Appendix H User Profiles 21 1 SYMBOLS USED ON...

Page 2: ...on 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 b...

Page 3: ...hin 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 cassett...

Page 4: ...ble 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 el...

Page 5: ...ay 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...

Page 6: ...6 Receptacle reserved for future functionality 7 Power ON OFF Switch and Power ON LED 8 Pressure Sensors Figure 2 Controller Rear 9 Equipotential Lug 10 Power Entry Module 11 Fuse Drawer 12 USB Acces...

Page 7: ...nt 6 Inflow to Patient 7 Inflow Pressure Diaphragm 8 Inflow Peristaltic Pump Tube 1 TPE Pump Tubing 2 Barb Lock 3 PVC Waste Tuing 4 Outflow Lumen 5 Barb Connector 6 Cassette Magnet Figure 5 Veriflow T...

Page 8: ...Date 01 SEP 2021 LBL 6028 Rev G Page 8 of 23 Figure 7 Tricera Handpiece LCD and Buttons 1 Activate 2 Coagulation 3 Joystick 4 Mode 9 5 Shaver Blades 1 Coupler 2 Hub 3 Shaft 4 Tip Figure 8 Tricera Devi...

Page 9: ...x H for user profile details 5 The Zimmer Biomet logo and self test progress will appear on the screen followed by the images shown in Figure 11 and 12 Figure 11 Figure 12 6 Open the FMA Cassette pack...

Page 10: ...e end of the Tricera handpiece as shown Figure 18 NOTE steps 14 17 apply to Veriflow FMA set R 10003 only 14 Select the joint for the procedure by touching the joint selection touchscreen or using the...

Page 11: ...at any time during the procedure 2 The Tricera Controller will set the following default pressure set point based on the initial joint selection Knee 45mmHg Shoulder 50mmHg Hip 50mmHg Small Joint 35m...

Page 12: ...e 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 applicabl...

Page 13: ...5 4 Allow 0 Suction YES and NO When this setting is set to Yes the suction level for Oscillate Bone Cutting Bone Burring Forward and Reverse all non RF modes shall be adjustable between 0 and 100 When...

Page 14: ...of merchantability and fitness for a particular purpose and all other obligations and liabilities on the part of Zimmer Biomet Zimmer Biomet neither assumes nor authorizes any other person to assume f...

Page 15: ...Pressure 878 to 1082 cmH2O 86 to 106 kPa IV Transport and Storage Requirements Temperature 18 C to 60 C Relative Humidity 15 to 85 non condensing Atmospheric Pressure 510 to 1082 cmH2O 50 to 106 kPa A...

Page 16: ...tomer service E11 E16 Inflow turns off High pressure detected on the inflow line Foreign object between diaphragm and pressure sensors Controller malfunction Remove any obstructions from inflow line o...

Page 17: ...t the footswitch is plugged into the gray port on the Controller Ensure the Handpiece is securely plugged into the connector Replace Tricera Device N A N A N A F12 Handpiece Cannot Position Window Pro...

Page 18: ...ntentional activation of RF output no unintentional activation of pump motors and correct pressure indication within one indicator bar II Power Curve Full and Half Output Power versus Load Resistance...

Page 19: ...ootswitch 10 ft Hospital Grade Power Cord Table 1 Electromagnetic Emissions Statement Guidance and Manufacturer s Declaration Electromagnetic Emissions The Tricera System is intended for use in the el...

Page 20: ...lity should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 4...

Page 21: ...3 79 3 79 7 27 100 12 0 12 0 23 0 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to...

Page 22: ...3000 6000 Forward RPM Reverse Default 1000 6000 6000 Reverse RPM Bone Cutting Default 3000 15000 15000 Bone Cutting RPM Bone Burring Default 3000 15000 15000 Bone Burring RPM RF Ablation Default 1 10...

Page 23: ...handpiece shall continue running when the button is released When a button is pressed again the motor shall stop running In RF modes or when Handpiece Button Latch non RF modes is Off activation shall...

Reviews: