Stryker L10, Инструкции для пользователей из Соединенных Штатов

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Product Description and Intended Use
The Stryker L10 LED Light Source with Advanced Imaging Modality
Technology (or “L10 AIM Light Source”) is a light-generating unit designed
to illuminate surgical sites in the following applications: visible light (White
Light mode), near-infrared fluorescence (ENV mode), and near-infrared
transillumination (IRIS mode).
• White Light mode:
The light source uses light-emitting diode (LED)
technology to generate bright, crisp light in the visible light spectrum that
is intended to illuminate surgical sites during endoscopic procedures. The
light is delivered to the surgical site through an endoscope via a fiber optic
light cable.
• ENV mode: The light source uses laser technology to generate light in the
near-infrared light spectrum, which is intended to enable fluorescence
imaging of anatomy that has been targeted with the contrast agent
indocyanine green. The light is delivered to the surgical site through an
endoscope via a fiber optic light cable.
• IRIS mode:
The light source uses laser technology to generate light in the
near-infrared light spectrum that is intended to transilluminate the ureter
during open or laparoscopic surgical procedures. The light is delivered to
the surgical site via a disposable fiber.
The light source is equipped with a safety feature that minimizes light output
if the fiber optic light cable is not connected to the scope adapter, which
prevents exposure to laser radiation, high-intensity light, and accidental
burns. For more information, see the section Checking the ESST Feature.
Indications
The L10 AIM Light Source and SafeLight™ Cable are indicated for use to
provide real-time endoscopic visible and near-infrared fluorescence imaging.
The L10 AIM Light Source and SafeLight Cable enable surgeons to perform
minimally invasive surgery using standard endoscope 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
and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L10 AIM Light Source and
SafeLight Cable is intended for use with standard-of-care white light and,
when indicated, intraoperative cholangiography. The devices are not
intended for standalone use for biliary duct visualization.
The L10 AIM Light Source is also intended to transilluminate the ureter during
open or laparoscopic surgical procedures.