Additional Information - Medtronic Affinity Pixie Gebrauchsanweisung

6. To vent the vacuum line, ensure that the Y-connector with side tubing is easily accessible and open to
atmosphere. This may be clamped and unclamped regularly throughout the procedure to apply or stop
vacuum.
Caution: Do not exceed vacuum levels greater than –6.67 kPa (–50 mmHg) as measured in the venous
line.
7. Ensure that all access ports on the CVR and manifold are properly sealed and are secure before initiating
bypass.
Caution: Vacuum will result in excess atmospheric air being entrained into the CVR and potentially into the
blood pathway with opened blood pathway ports. Vacuum may result in increased flow through the sampling
manifold during use.
8. Use vacuum assistance as needed to institute and maintain CPB.
Warning: Do not apply vacuum to the venous reservoir when there is no forward blood flow through the
oxygenator. This applies to arterial centrifugal and roller pumps (roller may not be occlusive in all positions).
This will prevent air from being pulled across the membrane into the blood path by the reservoir vacuum.
Warning: Do not allow the CVR to become pressurized as this could obstruct venous drainage, force air
retrograde into the patient or into the blood path of the oxygenator.

12. Additional information

The following additional information and data are available upon request: sterilization method, materials of the
blood pathway, plasma leakage across the semipermeable membrane, blood and gas pathway pressure drop at
the maximum blood and gas flow rates, blood cell damage, particle release, air-handling capability, antifoam
characteristics, breakthrough volume, filtration efficiency, relevant tolerances for data in the instructions for use,
protocol summaries, and test methods used to determine coverage, leaching, and bioactivity.
13. Important notice — limited warranty (for countries outside the US)
Important: This limited warranty does not apply in Australia.
A. This LIMITED WARRANTY provides assurance for the purchaser who receives an Affinity Pixie hollow fiber
oxygenator and/or cardiotomy/venous reservoir with Cortiva bioactive surface, hereafter referred to as the
"Product", that, should the Product fail to function to specification, Medtronic will issue a credit, equal to the
original Product purchase price (but not to exceed the value of the replacement Product) against the
purchase of any Medtronic replacement Product used for that patient.
The Warnings contained in the product labeling are considered an integral part of this LIMITED
WARRANTY. Contact your local Medtronic representative to obtain information on how to process a claim
under this LIMITED WARRANTY.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used prior to its Use-by date.
(2) The Product must be returned to Medtronic within 60 days after use and shall be the property of
Medtronic.
(3) The Product may not have been used for any other patient.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) In no event shall any replacement credit be granted where there is evidence of improper handling,
improper implantation or material alteration of the replaced Product.
(2) Medtronic is not responsible for any incidental or consequential damages based on any use, defect or
failure of the Product, whether the claim is based on warranty, contract, tort or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to,
contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held
by any court of competent jurisdiction to be illegal, unenforceable or in conflict with applicable law, the
validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and
obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular
part or term held to be invalid.
26 Instructions for Use English