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DCO-1318 

 

Effective Date: 01-SEP-2021

 

LBL 6028 Rev. G 

Page 22 of 23 

 

 

 

Left: User Profile Profile Selection Screen / Right: User Prorfile Insert Name Screen 

Table 4: Profile Settings 

Profile Screen 

Setting 

Minimum 

Default 

Maximum 

Description 

Suction 

Oscillate Default 

10% 

50% 

100 

Oscillate Suction 

Forward/Reverse Default 

10% 

50% 

100 

Forward/Reverse Suction 

Bone Cutting Default 

10% 

50% 

100 

Bone Cutting Suction 

Bone Burring Default 

10% 

50% 

100 

Bone Burring Suction 

Ablation Default 

10% 

20% 

30 

Ablation Suction 

Plasma Shaver Default 

10% 

50% 

100 

Plasma Shaver Suction 

Speed 

Oscillate Default 

1500 

3000 

5000 

Oscillate RPM 

Forward Default 

1000 

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 

10 

10 

Ablation Power Level 

Plasma Shaver Default 

10 

10 

Plasma Shaver Power Level 

Coag Default 

Coag Power Level 

Coag Suction 

0% 

20% 

20% 

Coag Suction 

Pressure 

Knee Pressure 

15 mmHg 

45 mmHg 

100 mmHg 

Default Pressure Setting when Knee Cavity is 

Selected 

Shoulder Pressure 

15 mmHg 

50 mmHg 

100 mmHg 

Default Pressure Setting when Shoulder Cavity is 

Selected 

Hip Pressure 

15 mmHg 

50 mmHg 

100 mmHg 

Default Pressure Setting when Hip Cavity is 

Selected 

Small Joint Pressure 

15 mmHg 

35 mmHg 

100 mmHg 

Default Pressure Setting when Small Joint Cavity 

is Selected 

 

 

Left: User Profile Suction Screen / Right: User Prorfile Speed Screen 

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...

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