Stryker PINPOINT PC9000 Manual Del Operador página 36

The Imaging System should not be used for NIR imaging during surgical
procedures with patients who are known to be sensitive to iodides or iodinated
imaging agents.
WARNING: Anaphylactic deaths have been reported following ICG administration during
cardiac catheterization.
Each vial of ICG and accompanying Sterile Water for Injection are intended for use
with only 1 patient and within 6 hours of reconstitution. Discard any unused
reconstituted ICG after each surgery is completed or 6 hours have lapsed since
reconstitution. If a precipitate is present upon reconstitution, do not use and discard
the solution.
ICG powder may cling to the vial or lump together because it is freeze-dried in the
vials. This is not due to the presence of water - the moisture content is carefully
controlled. The ICG is suitable for use.
The outside packaging of needles, syringes, stopcock, ICG vials, and the Sterile
Water for Injection are NOT sterile. The contents of the ICG vial are sterile and
must be handled aseptically to maintain the sterile field during surgery.
Radioactive iodine uptake studies should not be performed for at least a week
following the use of ICG for injection.
Pregnancy Category C: Animal Reproduction studies have not been conducted
with ICG. It is not known whether ICG can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. ICG should be given to a
pregnant woman only if clearly indicated.
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when ICG is administered to a nursing woman.
Only use ICG at indicated doses and concentrations as defined in the SPY
Portable Handheld Imaging System Operator's Manual.
Do not use needles, syringes, stopcocks, ICG vials and Sterile Water for Injection
that appear to have packaging or seals that are compromised in any way.
ICG is generally injected through a shared intravenous line with no reported
difficulties or unexpected results to date. However, drug / drug interactions have
not been identified in the ICG Package Insert.
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