da Vinci Xi, da Vinci X Systems, Instruments, and Accessories User Manual Addendum

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Copyright © 2024 Intuitive Surgical Operations, Inc. All rights reserved.

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Da Vinci Systems, Instruments, and Accessories User Manual Addendum

550901-04 Rev. B

Table of Contents

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Contents English ... 4 Bulgarian ...8 Czech ... 14 Danish... 19 Dutch ...24 Finnish ...29 French ...34 German ... 40 Greek ...45 Hungarian...50 Italian ...55 Norwegian ...60 Polish ...65 Portuguese... 71 Romanian ...76 Slovak ...82 Spanish ...87 Swedish ...92 Turkish ...97

Da Vinci Systems, Instruments, and Accessories User Manual Addendum

550901-04 Rev. B

English

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English (en) Introduction This addendum to the da Vinci System User Manual and da Vinci Instruments and Accessories User Manual contains a note regarding cardiac surgery and information regarding substances that are carcinogenic, mutagenic, toxic to reproduction (CMR), and/or endocrine-disrupting (ED). Keep this addendum with your da Vinci system user documentation. Note: The da Vinci system, instruments, and accessories are not intended specifically to control, diagnose, monitor or correct a defect of the heart, central circulatory or central nervous system through direct contact with those parts of the body.

Da Vinci Products The caution regarding carcinogenic, mutagenic, and reprotoxic (CMR) substances is applicable to da Vinci products. CAUTION: The da Vinci products may contain substances considered carcinogenic and toxic to reproduction. In particular, consider the residual risks prior to use on sensitive groups such as children, pregnant or breastfeeding women, or other patient groups considered particularly vulnerable to a substance that is carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).

Da Vinci Systems, Instruments, and Accessories User Manual Addendum

550901-04 Rev. B

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Da Vinci Products

The da Vinci products may contain the following CMR and/or ED substances in a concentration above 0.1% weight by weight. Table 1 List of CMR/ED substances in a concentration above 0.1% weight by weight #

Substances

Description

1

Cobalt Metal • CMR 1B • CAS number 7440-48-4 • EC number 231-158-0

Cobalt Metal may be present as an impurity in the stainless steel that the device is made up of; however, exposure to Cobalt-containing alloys such as stainless steel in medical devices via clinically relevant routes does not represent a hazard for carcinogenicity or reproductive toxicity since the risk for the adverse effects from Cobalt metal are negligible from the intended use of surgical stainless steel instruments.

2

N-Methylpyrrolidone • CMR 1A • CAS number 872-50-4 • EC number 212-828-1

The N-Methylpyrrolidone is present in the sheath covering of the I-Beam drive shaft, which cannot directly contact patient anatomy, but does have a path for fluid to contact the material.

See list of applicable da Vinci products below: Table 2 Da Vinci Products with applicable CMR and/or ED substances Part Number(s)

Product Name

Cobalt Metal

N-Methylpyrrolidone

480445

SureForm 45

Yes

Yes

480460

SureForm 60

Yes

Yes

480422

Vessel Sealer Extend

Yes

No

480440

SynchroSeal

Yes

No

470430

EndoWrist Stapler 30

Yes

No

470530

EndoWrist Stapler 30 Curved-Tip

Yes

No

480275

Harmonic ACE® Curved Shears

Yes

No

(continues on next page)

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Da Vinci Products

Table 2 Da Vinci Products with applicable CMR and/or ED substances (continued) Part Number(s)

Product Name

Cobalt Metal

N-Methylpyrrolidone

480299

Suction Irrigator

Yes

No

480545

SureForm 45 CurvedTip

Yes

No

470001

Potts Scissors

Yes

No

470006

Large Needle Driver

Yes

No

470036

Debakey Forceps

Yes

No

470048

Long Tip Forceps

Yes

No

Cadiere Forceps

Yes

No

470181

Resano Forceps

Yes

No

470190

Cobra Grasper

Yes

No

470230

Large Clip Applier

Yes

No

470327

Medium-Large Clip Applier

Yes

No

470401

Small Clip Applier

Yes

No

470007

Round Tip Scissors

Yes

No

470033

Black Diamond Micro Forceps

Yes

No

470179

Monopolar Curved Scissors

Yes

No

470194

Mega Needle Driver

Yes

No

470207

Tenaculum Forceps

Yes

No

470249

Dual Blade Retractor

Yes

No

470296

Large SutureCut Needle Driver

Yes

No

Mega SutureCut Needle Driver

Yes

No

471006a

471048a 470049 471049a

471190a

471296a 470309 471309a (continues on next page)

Da Vinci Systems, Instruments, and Accessories User Manual Addendum

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Da Vinci Products

Table 2 Da Vinci Products with applicable CMR and/or ED substances (continued) Part Number(s)

Product Name

Cobalt Metal

N-Methylpyrrolidone

470318

Small Grasping Retractor

Yes

No

470093

ProGrasp Forceps

Yes

No

Micro Bipolar Forceps

Yes

No

Maryland Bipolar Forceps

Yes

No

Fenestrated Bipolar Forceps

Yes

No

Curved Bipolar Dissector

Yes

No

470347

Tip-Up Fenestrated Grasper

Yes

No

470400

Long Bipolar Grasper

Yes

No

Force Bipolar

Yes

No

488430

8 mm SureForm 30

Yes

Yes

488530

8 mm SureForm 30 Curved-Tip

Yes

Yes

471093a 470171 471171a 470172 471172a 470205 471205a 470344 471344a

471400a 470405 471405a

Notes a. Instrument has increased number of uses before expiration. Symbol

Meaning Contains hazardous substances. Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties. End

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Prodotti da Vinci

Tabella 2 Prodotti da Vinci con sostanze CMR e/o ED applicabili (segue) Numero parte

Nome prodotto

Cobalto metallico

N-metilpirrolidone

470430

EndoWrist Stapler 30 (Suturatrice EndoWrist 30)

Sì

No

470530

EndoWrist Stapler 30 Curved-Tip (Suturatrice EndoWrist 30 punta curva)

Sì

No

480275

Harmonic ACE® Curved Shears (Cesoie curve Harmonic ACE®)

Sì

No

480299

Suction Irrigator (Aspiratore/irrigatore)

Sì

No

480545

SureForm 45 CurvedTip (SureForm 45 punta curva)

Sì

No

470001

Potts Scissors (Forbice di Potts)

Sì

No

470006

Large Needle Driver (Portaghi grande)

Sì

No

470036

DeBakey Forceps (Pinza di DeBakey)

Sì

No

470048

Long Tip Forceps (Pinza a punta lunga)

Sì

No

Cadiere Forceps (Pinza Sì Cadiere)

No

470181

Resano Forceps (Pinza Resano)

Sì

No

470190

Cobra Grasper (Pinza da presa Cobra)

Sì

No

Large Clip Applier (Applicatore di clip grandi)

Sì

No

471006a

471048a 470049 471049a

471190a 470230

(segue alla pagina successiva)

Da Vinci Systems, Instruments, and Accessories User Manual Addendum

550901-04 Rev. B

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Da Vinci Systems, Instruments, and Accessories User Manual Addendum

550901-04 Rev. B