Stryker L10, Инструкции для пользователей из Соединенных Штатов

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Precautions
• Federal law (USA) restricts this device to use by, or on order of, a
physician.
• Observe sterile handling techniques when preparing and
administering the ICG solution. The inner contents of the ICG powder
vial and Sterile Water for Injection, USP capsule are sterile. Handle
them aseptically during the procedure to maintain the sterile field.
Do not use any of these packages if they appear to be damaged or
improperly sealed.
• Due to freeze drying, the ICG powder may lump together or cling to
the vial. This is normal and the ICG should be suitable for use after
reconstitution with the Sterile Water for Injection, USP. If a precipitate
is present after preparation, however, discard the solution.
• Use only the Sterile Water for Injection, USP provided with the AIM IC-
GREEN kit to dissolve the ICG powder. Commercially available water for
injection may be incompatible and should not be used.
• Each preparation of the ICG solution should be used in only one
patient. Once the ICG solution is prepared, it must be used within
6 hours. ICG is not stable in aqueous solution.
• Heparin preparations that contain sodium bisulfite reduce the
absorption peak of ICG in blood. Do not use heparin preparations with
sodium bisulfite as an anticoagulant for the collection of samples for
analysis.
• Radioactive iodine uptake studies should not be performed for at least
one week after the use of ICG.
• The potential for ICG to impair fertility or have a carcinogenic or
mutagenic effect has not been studied. ICG should be administered
to a pregnant woman only when clearly indicated. Exercise caution
when administering ICG to a nursing woman. It is not known if ICG is
excreted in human milk.
• ICG is generally injected through a shared intravenous line with no
reported difficulties or unexpected results to date.
• Use ICG only at recommended doses and concentrations listed in this
user manual.