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Da Vinci | Xi | X
intuitive.com
European Union Systems, Instruments, and Accessories User Manual Addendum
Intuitive Surgical, Inc.
Intuitive Surgical SAS
1266 Kifer Road
11 avenue de Canteranne
Sunnyvale, CA 94086 USA
33600 Pessac, France
intuitive.com
PN 550901-04 Rev. B 2024.01
2460
2
Copyright © 2024 Intuitive Surgical Operations, Inc. All rights reserved.
Trademarks Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See intuitive.com/trademarks.
Da Vinci Systems, Instruments, and Accessories User Manual Addendum
550901-04 Rev. B
Table of Contents
3
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
4
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
5
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)
Da Vinci Systems, Instruments, and Accessories User Manual Addendum
550901-04 Rev. B
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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
Da Vinci Systems, Instruments, and Accessories User Manual Addendum
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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)
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550901-04 Rev. B
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Da Vinci Systems, Instruments, and Accessories User Manual Addendum
550901-04 Rev. B