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da Vinci Xi Accessories Reprocessing Instructions Appendices
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da Vinci Xi Reprocessing Instructions Appendices
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Additional Information for Cleaning, Disinfection, and Sterilization of Reusable Devices that are used with the da Vinci Xi System
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The reprocessing instructions and parameters given represent the manufacturer’s recommendations according to ISO 17664. These Reprocessing Appendices are intended to be used together with the Xi Instrument Reprocessing Instructions (PN 554152), the Xi Endoscope Reprocessing Instructions (PN 554151), the Xi Accessories Reprocessing Instructions (PN 554153), and the da Vinci Handheld Camera Reprocessing Instructions (PN 554120), which are provided as separate documents.
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Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA
Intuitive Surgical SAS 11 avenue de Canteranne 33600 Pessac, France
www.intuitive.com Customer Service 800.876.1310
Customer Service (Europe) +800.0821.2020
PN 554154-03 Rev. C
2460
Copyright © 2021 Intuitive Surgical Operations, Inc. All rights reserved. Trademarks Intuitive, Intuitive Surgical, da Vinci Xi, EndoWrist, and Single-Site are trademarks or registered trademarks of Intuitive Surgical. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See www.intuitive.com/trademarks.
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da Vinci Xi Reprocessing Instructions Appendices
Table of Contents INTRODUCTION
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APPENDIX A
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Validated Instruments, Endoscopes, and Accessories 8 mm Instruments Single-Site Instruments Staplers Endoscopes Handheld Camera and Accessories Accessories: Group 1 Accessories: Group 2 Accessories: Group 3 Single Use Instruments Single Use Accessories
APPENDIX B
Washer Disinfectors Validated Washer Disinfectors Typical Washer Disinfector Parameters
APPENDIX C
Validated Trays and Containers Summary of Validated Trays and Containers 8 mm Instruments and Accessories Trays 8 mm Instruments Container Single-Site Instruments and Accessories Trays Stapler Trays Endoscope Trays Handheld Camera Tray
da Vinci Xi Reprocessing Instructions Appendices
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(continued)
Table of Contents APPENDIX D
Validated Compatibility Matrix for Instruments, Endoscopes, and Accessories Compatibility Matrix Pre-Vacuum Steam Sterilization Table Validated Endoscope Sterilization Cycles Validated Handheld Camera Sterilization Cycles
BIBLIOGRAPHY
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da Vinci Xi Reprocessing Instructions Appendices
INTRODUCTION
Introduction
These appendices provide additional information for the reprocessing instructions listed in the table below. REPROCESSING INSTRUCTIONS
REPROCESSING INSTRUCTIONS PART NUMBER
da Vinci Xi Instrument Reprocessing Instructions
554152
da Vinci Xi Endoscope Reprocessing Instructions
554151
da Vinci Xi Accessories Reprocessing Instructions
554153
da Vinci Handheld Camera Reprocessing Instructions
554120
da Vinci Xi Reprocessing Instructions Appendices
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da Vinci Xi Reprocessing Instructions Appendices
Appendix A
Validated Instruments, Endoscopes, and Accessories All reusable da Vinci Xi instruments, endoscopes, and accessories listed in Appendix A are compatible with both the da Vinci Xi and the da Vinci X systems. Not all technologies have regulatory approval or are commercially available in all geographies. For availability in your country, please check with your local representative.
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
8 MM INSTRUMENTS
8 mm Instruments
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da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470001
Potts Scissors
10
15
470006
Large Needle Driver
470007
Round Tip Scissors
470033
Black Diamond Micro Forceps
15
20
470036
DeBakey Forceps
10
15
470048
Long Tip Forceps
470049
Cadiere Forceps
470093
ProGrasp™ Forceps
470171
Micro Bipolar Forceps
470172
Maryland Bipolar Forceps
470179
Monopolar Curved Scissors
470181
Resano Forceps
470183
Permanent Cautery Hook
470184
Permanent Cautery Spatula
470190
Cobra Grasper
470194
Mega Needle Driver
470205
Fenestrated Bipolar Forceps
da Vinci Xi Reprocessing Instructions Appendices
APPENDIX A
8 MM INSTRUMENTS
(continued)
8 mm Instruments da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470207
Tenaculum Forceps
10
15
470215
Cardiac Probe Grasper¹
470230
Large Clip Applier
100 clips
25
470246
Atrial Retractor Short Right¹
10
15
470249
Dual Blade Retractor
470296
Large SutureCut™ Needle Driver
470309
Mega SutureCut™ Needle Driver
470318
Small Graptor™ Grasping Retractor
470327
Medium-Large Clip Applier
100 clips
25
470344
Curved Bipolar Dissector
10
15
470347
Tip-Up Fenestrated Grasper
470400
Long Bipolar Grasper
470401
Small Clip Applier
100 clips
25
470405
Force Bipolar
10
15
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
8 MM INSTRUMENTS
(continued)
8 mm Instruments
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da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
471006
Large Needle Driver
15
20
471048
Long Tip Forceps
18
23
471049
Cadiere Forceps
471093
ProGrasp™ Forceps
471171
Micro Bipolar Forceps
14
19
471172
Maryland Bipolar Forceps
471190
Cobra Grasper
18
23
471205
Fenestrated Bipolar Forceps
14
19
471296
Large SutureCut™ Needle Driver
15
20
471309
Mega SutureCut™ Needle
471344
Curved Bipolar Dissector
14
19
471400
Long Bipolar Grasper
471405
Force Bipolar
12
17
Driver
da Vinci Xi Reprocessing Instructions Appendices
APPENDIX A
SINGLE-SITE INSTRUMENTS
Single-Site Instruments
not commercially available in some countries
da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
478050
Single-Site Maryland Dissector
10
15
478052
Single-Site Medium-Large Clip Applier, FAS
75 clips
30
478053
Single-Site Medium-Large Clip Applier
80 clips
30
478054
Single-Site Suction Irrigator
20
25
478055
Single-Site Cadiere Forceps
10
15
478057
Single-Site Curved Scissors
7
12
478058
Single-Site Fundus Grasper
10
15
478059
Single-Site Crocodile Grasper
478088
Single-Site Curved Needle Driver
478090
Single-Site Permanent Cautery Hook
478114
Single-Site Wristed Needle Driver, FAS
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10
478115
Single-Site Wristed Needle Driver
10
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da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
STAPLERS AND ENDOSCOPES
Staplers da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470430
da Vinci Xi EndoWrist Stapler 30
50 firings
25
470530
da Vinci Xi EndoWrist Stapler 30 Curved-Tip
470298
da Vinci Xi EndoWrist Stapler 45
470545
da Vinci Xi EndoWrist Stapler 45 Curved-Tip
Endoscopes
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da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470026
8 mm Endoscope, 0°
N/A
N/A
470027
8 mm Endoscope, 30°
470056
8 mm Endoscope Plus, 0°
470057
8 mm Endoscope Plus, 30°
da Vinci Xi Reprocessing Instructions Appendices
APPENDIX A
HANDHELD CAMERA AND ACCESSORIES
Handheld Camera and Accessories da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470035
Handheld Camera
N/A
N/A
470042
Handheld Camera Light Guide Cable
470051
Handheld Camera Removable Light Guide Adapter
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
ACCESSORIES: GROUP 1
Accessories: Group 1
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da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
342562
Instrument Introducer
N/A
N/A
381215
da Vinci Xi EndoWrist Stapler Release Kit
381216
Instrument Release Kit
428064
5 x 300 mm Flexible Blunt Obturator
428074
5 x 250 mm Flexible Blunt Obturator
428076
10 mm Accessory Cannula
428084
10 mm Blunt Obturator
470002
8 mm Instrument Cannula
470004
8 mm Cannula, Long
470008
8 mm Blunt Obturator
470009
8 mm Blunt Obturator, Long
470375
da Vinci Xi EndoWrist 12 mm & Stapler Cannula
470376
da Vinci Xi EndoWrist 12 mm & Stapler Blunt Obturator
470389
da Vinci Xi EndoWrist 12 mm & Stapler Cannula, Long
470390
da Vinci Xi EndoWrist 12 mm & Stapler Blunt Obturator, Long
da Vinci Xi Reprocessing Instructions Appendices
APPENDIX A
ACCESSORIES: GROUP 1
(continued)
Accessories: Group 1 da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470395
da Vinci Xi EndoWrist 12 mm & Stapler Bladeless Obturator, Standard
N/A
N/A
470396
da Vinci Xi EndoWrist 12 mm & Stapler Bladeless Obturator, Long
470397
8 mm Cannula Gage Pin
470398
8 mm Hasson Cone
470399
da Vinci Xi EndoWrist 12 mm & Stapler Hasson Cone
478008
8 mm Blunt Obturator
478013
5 mm Blunt Obturator
478060
5 mm Accessory Cannula
478061
5 x 300 mm Curved Cannula (Endoscope Right)
478062
5 x 300 mm Curved Cannula (Endoscope Left)
478071
5 x 250 mm Curved Cannula (Endoscope Right)
478072
5 x 250 mm Curved Cannula (Endoscope Left)
478263
8 mm Endoscope Cannula
470319
8 mm Flared/Grounded Cannula
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
ACCESSORIES: GROUP 2 AND 3
Accessories: Group 2 da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470383
Monopolar Cautery Cord
20
25
470384
Bipolar Cautery Cord
Accessories: Group 3
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da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
400490
8 mm Endoscope Sterilization Tray (Plastic)
N/A
N/A
400498
8 mm Stainless Steel Endoscope Reprocessing Tray (Stainless Steel)
400499
da Vinci Handheld Camera Sterilization Tray
da Vinci Xi Reprocessing Instructions Appendices
APPENDIX A
SINGLE USE INSTRUMENTS
Single Use Instruments
do not reprocess
da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
480275
8 mm Harmonic ACE®
480322
8 mm Vessel Sealer
480299
8 mm Suction Irrigator
480440
Synchroseal™
480422
Vessel Sealer Extend
480545
SureForm™ 45 Curved-Tip Instrument
480445
SureForm™ 45 Instrument
480460
SureForm™ 60 Instrument
478080
Single-Site Maryland Bipolar Forceps
478093
Single-Site Fenestrated Bipolar Forceps
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX A
SINGLE USE ACCESSORIES
(continued)
Single Use Accessories
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do not reprocess
da Vinci Xi PART NUMBER
PRODUCT DESCRIPTION
400180
Tip Cover Accessory (Monopolar Curved Scissors)
48345
Reload, SureForm™ 45
48360
Reload, SureForm™ 60
410370
EndoWrist® Stapler Sheath
478161
Single-Site Cannula Seal
478065
Single-Site Port
48445
Reload, Stapler 45
48630
Reload, Stapler 30
48645
Reload, Stapler 45
470359
8 mm Bladeless Obturator (Optical)
470360
8 mm Bladeless Obturator, Long (Optical)
470381
8 mm Reducer
470361
5 mm - 8 mm Cannula Seal
470380
12 mm & Stapler Cannula Seal
da Vinci Xi Reprocessing Instructions Appendices
Appendix B Washer Disinfectors
da Vinci Xi Reprocessing Instructions Appendices
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APPENDIX B
VALIDATED WASHER DISINFECTORS
Validated Washer Disinfectors WARNING Cleaning processes described in these instructions have been validated by Intuitive. Alternative cleaning processes may result in incomplete reprocessing, which may lead to patient harm.
NOTE •
The table below shows examples of washer disinfector manufacturers and models that have been validated in accordance to ISO 15883-1. Please contact the washer disinfector manufacturer to receive the current list of validated models that are compatible with da Vinci instruments.
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Only use a washer disinfector that has been validated for efficacy in accordance to ISO 15883-1.
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The hospital shall validate the efficacy of its cleaning process if required by national regulations.
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Follow the instructions of the washer disinfector manufacturer.
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Use only pH-neutral to mildly alkaline cleaning agent (pH 7–11) that is compatible with the specific washer disinfector.
MANUFACTURER
MODEL
VALIDATED PRODUCT FAMILIES
CYCLE
Atherton
Platypus IQ6
8 mm Instruments
Belimed
WD 290
Use the manufacturer's recommended wash cycle.
WD 290 IQ Getinge
8668 88 Turbo
20
KEN
IQ6
Matachana
LD1000
Miele
PG 8528
Skytron
Sterling P1800
Single-Site Instruments Staplers Endoscopes Handheld Camera and Accessories Accessories (Groups 1, 2, and 3)
For instruments, use the manufacturer's wash rack which connects to the instrument flush ports. For endoscopes, use the validated tray (PN 400498) and connector set (PN 400482). For handheld camera, use the validated tray (PN 400499).
da Vinci Xi Reprocessing Instructions Appendices