the patient's risk tolerance for hemoglobinemia and related sequelae prior to
the procedure. Consider hydration prior to, during, and after the procedure as
appropriate to the patient's overall medical condition.
Caution: Large thrombus burdens in peripheral veins and other vessels may result
in significant hemoglobinemia which should be monitored to manage possible renal,
pancreatic, or other adverse events.
note: If the Thrombectomy Set is removed and/or inoperative, the Thrombectomy
Set tubing, guide catheter and sheath should be flushed with HepNS to avoid
thrombus formation and maintain lumen patentcy. Re-prime the Thrombectomy
Set by submerging the tip in HepNS and operating it for at least 20 seconds before
reintroduction to the patient.
8. Follow proper precautions for the handling of infectious waste. Reuse of
Thrombectomy Set is prohibited. Refer to the Console Operator's Manual for
Console cleaning instructions and proper disposal of the Thrombectomy Set.
paTIenT InforMaTIon
No separate patient information is provided because the catheter is used in association
with other interventional procedures. Risks and benefits to the patient are similar to and,
from the patient's perspective, a part of those interventional procedures.
warranTy
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in
the design and manufacture of this instrument. This warranty is in lieu of and excludes
all other warranties not expressly set forth herein, whether express or implied by
operation of law or otherwise, including, but not limited to, any implied warranties
of merchantability or fitness for a particular purpose. Handling, storage, cleaning and
sterilization of this instrument as well as other factors relating to the patient, diagnosis,
treatment, surgical procedures and other matters beyond BSC's control directly affect
the instrument and the results obtained from its use. BSC's obligation under this
warranty is limited to the repair or replacement of this instrument and BSC shall not be
liable for any incidental or consequential loss, damage or expense directly or indirectly
arising from the use of this instrument. BSC neither assumes, nor authorizes any other
person to assume for it, any other or additional liability or responsibility in connection
with this instrument. bsC assumes no liability with respect to instruments reused,
reprocessed or resterilized and makes no warranties, express or implied, including
but not limited to merchantability or fitness for a particular purpose, with respect to
such instruments.
Black (K) ∆E ≤5.0
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