Intuitive Surgical
8mm Endoscope Plus, 30°
Endoscope Plus Addendum to the Reprocessing Instructions Appendices
8 Pages
Preview
Page 1
Addendum to the Reprocessing Instructions Appendices
Supplemental instructions for the cleaning, disinfection, and sterilization information for Endoscopes used with da Vinci Xi and da Vinci X System The reprocessing instructions and parameters given represent the manufacturer’s recommendations according to BS EN ISO 17664:2017. This Addendum is intended to be used together with the Reprocessing Instructions Appendices, which is provided in a separate document (554154).
1
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA
Intuitive Surgical, Sàrl Chemin des Mȗriers 1 1170 Aubonne, Switzerland
www.intuitivesurgical.com Customer Service 800.876.1310
Customer Service (Europe) +800.0821.2020
PN 555165-01 Rev. C
4
7
Endoscope Plus
1
2
3
4
da Vinci Xi Reprocessing Instructions Appendices Addendum
Copyright © 2019 Intuitive Surgical, Inc. All rights reserved.
Trademarks Intuitive Surgical, da Vinci Xi, da Vinci X, and EndoWrist, are trademarks or registered trademarks of Intuitive Surgical, Inc. Product names are trademarks or registered trademarks of their respective holders.
2
da Vinci Xi Reprocessing Instructions Appendices Addendum
Table of Contents INTRODUCTION
4
APPENDIX A
5
Endoscopes
7
BIBLIOGRAPHY
8
European Standards Standards Specific to Germany
8 8
da Vinci Xi Reprocessing Instructions Appendices Addendum
3
INTRODUCTION
Introduction
This addendum is intended to be used together with the da Vinci Xi Reprocessing Instructions Appendices.
4
REPROCESSING INSTRUCTIONS
REPROCESSING INSTRUCTIONS PART NUMBER
da Vinci Xi Reprocessing Instructions Appendices
554154
da Vinci Xi Reprocessing Instructions Appendices Addendum
Appendix A
da Vinci Xi Reprocessing Instructions Appendices Addendum
5
THIS PAGE LEFT INTENTIONALLY BLANK
6
da Vinci Xi Reprocessing Instructions Appendices Addendum
APPENDIX A
ENDOSCOPES
Endoscopes da Vinci Xi PRODUCT CODES
PRODUCT DESCRIPTION
NUMBER OF USES
NUMBER OF REPROCESSING CYCLES
470056
8 mm, Endoscope Plus, 0°
N/A
N/A
470057
8 mm, Endoscope Plus, 30°
N/A
N/A
da Vinci Xi Reprocessing Instructions Appendices Addendum
7
BIBLIOGRAPHY
Bibliography
The following international and national standards are stated for reference and were consulted in the formulation of this document.
European Standards
• BS EN ISO 17664:2017 – Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices • Directive (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Official Journal of the European Union L396 of 30.12.2006 • Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal of the European Union L 169 of 12/07/1993 P. 0001- 0043 • BS EN ISO 15883-1: 2009+A1:2014 Washer/disinfectors Part 1: General requirements, terms and definitions and tests • BS EN ISO 15883-2: 2009 Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. • BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems • BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices • BS EN 20594-1:1994 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. General requirements • BS ISO 8573-01:2010 Compressed Air. Contaminants and purity classes.
Standards Specific to Germany
• Regulation concerning the construction, operation and use of medical products. Recommendations of the Committee for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) (Federal Health Gazette 201255:1244–1310. DOI 10.1007/s00103-012-1548-6) • Regulation concerning the construction, operation and use of medical products (medical product operator regulation, MPBetreibV)
8
da Vinci Xi Reprocessing Instructions Appendices Addendum