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Zimmer Biomet Tricera, Инструкция по эксплуатации

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Zimmer Biomet Tricera Скачать руководство пользователя страница 8

 

DCO-1318 

 

Effective 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 Device 

1 

3

 

2

 

4

 

1 

2

 

3

 

4

 

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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