Da Vinci Firefly Imaging System User Manual Addendum 552064-10 Rev. A
Introduction
This addendum to the
da Vinci Xi System User Manual
and the
da Vinci X System User Manual
provides details specific to the Firefly Imaging System.
Note: Aspects of the da Vinci Firefly Imaging System not addressed in this document are
the same as for the da Vinci Vision system. For details, refer to the applicable system user
manual, including current addenda, if any.
Note: All da Vinci instruments and accessories are compatible with both the da Vinci
systems.
This addendum to the user manual presents representative images of the system, instruments,
accessories, and user interface. The representative images provide instruction on the use of the
product. In some cases, the aesthetics or dimensions of the device shown in the representative
images may be different from the product in use.
Indications for Use
Upon intravenous administration and use of an ICG drug product consistent with its approved
label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and
near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to
perform minimally invasive surgery using standard endoscopic visible light as well as visual
assessment of vessels, blood flow and related tissue perfusion, and at least one of the major
extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near
infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use
with standard of care white light and, when indicated, intraoperative cholangiography. The device
is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of an ICG drug product consistent with its approved label,
the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and
visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Safety Information for Indocyanine Green
The da Vinci Firefly Imaging System is restricted for use only with legally-marketed indocyanine
green (ICG) imaging agent that has indications for use consistent with its approved label and
indications for use with a fluorescence imaging device.
Note: For information on the imaging agent precautions, warnings, and contraindications,
refer to the imaging agent labeling.
ICG Contraindications
Indocyanine green is contraindicated in patients with a history of hypersensitivity to indocyanine
green. Reactions have included anaphylaxis.
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Introduction
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