Stryker L10, Инструкции для пользователей из Соединенных Штатов

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Using AIM IC-GREEN in ENV Mode
Endoscopic Near-Infrared Visualization (ENV) mode is intended to be used
with a contrast agent drug called indocyanine green (ICG).
AIM IC-GREEN®
(NDC # 17478-801-02) includes the required ICG supplies.
Note:
In the United States, the L10 LED Light Source with AIM Technology
and SafeLight Fiber Optic Cable are indicated for use only with AIM IC-GREEN.
For users outside the U.S., refer to Stryker user manual P27009.
• Indocyanine green is a sterile, water soluble tricarbocyanine dye with a
peak spectral absorption at 800 nm in blood or blood plasma.
• ICG contains not more than 5.0% sodium iodide.
• ICG is administered intravenously. Under sterile conditions, the ICG
powder should be dissolved with the provided Sterile Water for
Injection, USP. AIM IC-GREEN has a pH of approximately 6.5 when
reconstituted.
• Use of the ICG dye promotes the fluorescing appearance of the camera
image in ENV mode.
Each AIM IC-GREEN kit contains the following items:
• Six 25 mg vials of indocyanine green (ICG) imaging agent
• Six 10 mL ampules of Sterile Water for Injection, USP
• Instructions for use
See the ENV Mode Requirements section for complete hardware
requirements. The contents of AIM IC-GREEN must be used only with the
L10 AIM Light Source.
To use AIM IC-GREEN in conjuction with ENV mode, follow the instructions
and warnings below. The instructions for use are also packaged with AIM IC-
GREEN (NDC # 17478-801-02).