Zimmer Biomet Tricera Скачать руководство пользователя страница 14

 

DCO-1318 

 

Effective Date: 01-SEP-2021

 

LBL 6028 Rev. G 

Page 14 of 23 

 

15.7.

 

Controller Language Setting 

The Controller touchscreen GUI language can be set to English, 

French, Italian, German, Spanish, Greek, Portuguese, 

Portuguese (Brazil), and Russian. The GUI language is selected 

using the arrows on either side of the language displayed in the 

settings menu.

 

15.8.

 

Replacing a Fuse in the Controller 

In the event of a blown fuse, only 5x20mm 6.3A/250VAC Type “T” (slow 

blow) fuses should be used as replacements.  Turn power off and 

disconnect the power cord from the electrical outlet.  Remove the fuses 

by opening the Power Entry Module’s Fuse Drawer (Fig. 2, Item 11) on 

the back of the Controller.  Replace both fuses with new ones; then 

close the fuse drawer.  Other than the fuses, there are no user 

serviceable parts.  For replacement, return cleaned unit to manufacturer.   

15.9.

 

Troubleshooting 

See 

Appendix E

 for further information on Troubleshooting.    

16. 

LIMITED WARRANTY 

Zimmer Biomet warrants to the original purchaser of Tricera Controller 

that the Controller will be free of defects in material and workmanship 

for a period of one year after the date of purchase when used as 

intended under normal operating conditions and in conformance with its 

instructions for use and maintenance instructions.  Any warranty 

concerning software and/or hardware upgrades shall expire in the 

original one-year warranty.  The sole obligation of Zimmer Biomet and 

its affiliates under this warranty shall be limited to the replacement of the 

Tricera Controller or equivalent models, at no charge to the original 

purchaser and at the option of Zimmer Biomet, during the warranty 

period but only if examination reveals to the satisfaction of Zimmer 

Biomet that the Controller contains a defect in material or workmanship. 

 

Zimmer Biomet and its affiliates will not be liable for any incidental, 

special or consequential loss, damage, or expense resulting, directly or 

indirectly, from the use of its product regardless of whether Zimmer 

Biomet or its affiliates have been advised of the possibility of such loss, 

damage or expense. 
This warranty is made in lieu of all other warranties, expressed, implied 

or statutory, including, but not limited to the implied warranties 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 for it any 

other liability in connection with the sale of the Tricera Controller.  This 

warranty shall not apply to the Tricera Controller or any other part 

thereof that has been subject to accident, negligence, alteration, abuse 

or misuse.  Zimmer Biomet makes no warranty whatsoever with regard 

to accessories or parts used in conjunction with the Tricera Controller 

and not supplied and manufactured by Zimmer Biomet. 
No agent, employee, or representative of Zimmer Biomet or its affiliates 

has any authority to change any of the foregoing or assume or bind 

Zimmer Biomet or any of its affiliates to any additional liability or 

responsibility in connection with this device.  The essential purpose of 

this provision is to limit the potential liability of Zimmer Biomet and its 

affiliates arising out of this agreement and/or any purchase and sale 

hereunder.  Original purchaser shall be responsible for ongoing 

equipment support and maintenance not covered by this warranty and 

after the warranty period has expired. 

The term “original purchaser,” as used in this warranty means that 

person or organization and its employees, if applicable, to whom the 

Tricera Controller was sold by Zimmer Biomet.  This warranty may not 

be assigned or transferred in any manner. 
In order to make a warranty claim, the original customer must obtain a 

Return Materials Authorization Number (“RMA Number”) and return 

instructions from Zimmer Biomet’s Customer Service Department or 

authorized representative.  The allegedly defective Controller must be 

returned, cleaned, repackaged, clearly marked with the RMA number on 

all packaging, and adequately insured, to the following address: Zimmer 

Biomet, 655 Campbell Technology Parkway, Suite 275, Campbell, CA 

95008. 

17. 

CUSTOMER SERVICE/TECHNICAL 

SUPPORT 

Contact Zimmer Biomet’s Customer Service for customer or technical 

support.   

Call +1-800-253-6190or e-mail at [email protected]. 

 

 

 

Zimmer Biomet 

655 Campbell Technology Parkway, 

Suite 275 

Campbell, CA 95008, USA 

+1-800-253-6190 

[email protected] 

www.religncorp.com 

 

 

 

0459

 

 
 

 

Authorized Representative 

MedPass International SAS 

95 Bis Boulevard Péreire 

75017 Paris France 

+33 (0)1 42 12 83 30 

 

 

 

© 2019 Zimmer Biomet Corporation or its affiliates. All rights 

reserved. 

 

Содержание Tricera

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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