User's Manual Part 1

da Vinci
®
Si™
Introduction
1-3
DRAFT/PRE-RELEASE/CONFIDENTIAL
10/9/14
Compliance and Classifications
The Intuitive Surgical da Vinci Si Endoscopic Instrument Control System, Model IS3000, is in
conformance with the Medical Device Directive, 93/42/EEC.
The da Vinci Si System is designed to be in compliance with IEC 60601-1, with the following
mode of operation, and type and degree of protection against electric shock.
• Mo
de of Operation: C
ontinuous
• Type of Protection: Class I
• Degree of Protection: CF f
or all patient applied parts (inserted portion of instruments),
except BF for PK Dissecting Forceps. Please see Instruments and Accessories User Manual
(PN 550675) for additional details.
• Ingr
ess Protection: Or
dinary, except footswitch on the Surgeon Console, which is rated
IPX8.
The da Vinci Si Endoscopic Instrument Control System (Model IS3000) is manufactured in the
USA.
The system components may have labels as represented in Figure 1.1 and Figure 1.2.
For labels as represented in Figure 1.1 (IEC 2
nd
Edition) the da Vinci Si System Model IS3000 is
classified with respect to electric shock, fire and mechanical hazards only in accordance with
UL60601-1, CAN/CSA C22.2 No. 601.1, IEC and CAN/CSA C22.2 Nos. 60601-1, 60601-1-1,
60601-1-4, 60601-2-2, and 60601-2-18.
For labels as represented in Figure 1.2 (IEC 3
rd
Edition) the da Vinci Si System Model IS3000 is
classified with respect to electric shock, fire and mechanical hazards only in accordance with
ANSI/AAMI ES60601-1 (2005/(R) 2012), CAN/CSA-C22.2 Nos. 60601-1 (2014), 60601-2-2 (2009),
60601-2-18 (2011), and IEC publications 60601-1 (2012), 60601-2-2 (2009), and 60601-2-18
(2009).
The da Vinci Si system, also referred to as the Endoscopic Instrument Control System Model
IS3000, consists of a Surgeon Console, Model SS3000, Patient Cart, Model PS3000, and Vision
Cart, Model VS3000; the Vision Cart contains the Core, Model CR3000, and Camera Control
Unit (CCU), Model DC3000. The Surgeon Console, Model SS3000, the Patient Cart, Model
PS3000, and the Vision Cart, Model VS3000, including the Core, Model CR3000, and Camera
Control Unit (CCU), Model DC3000, have been evaluated for compliance with above
referenced standards by a Nationally Recognized Test Laboratory (NRTL), Underwriters
Laboratories, Inc. (UL). Accessories referenced in the Instruments and Accessories User Manual
were not covered by the UL evaluation.
CAUTION: The da Vinci Si is not suitable for use in the presence of a flammable
anesthetic mixture of air, oxygen and/or nitrous oxide.
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 USA
www.intuitivesurgical.com
Intuitive Surgical Sàrl
1, chemin des Mûriers,
1170 Aubonne Switzerland