da Vinci Xi Accessories Reprocessing Instructions Appendices

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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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23 24 26 28 29 31 32 34

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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

8

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

9

APPENDIX A

8 MM INSTRUMENTS

(continued)

8 mm Instruments

10

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

5

10

478115

Single-Site Wristed Needle Driver

10

15

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.

•

Only use a washer disinfector that has been validated for efficacy in accordance to ISO 15883-1.

•

The hospital shall validate the efficacy of its cleaning process if required by national regulations.

•

Follow the instructions of the washer disinfector manufacturer.

•

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