Additional Information - Medtronic Affinity NT Gebrauchsanweisung

b. To increase PCO
3. Patient temperature is controlled by regulating the temperature of water flow into the heat exchanger.
Note: Care should be taken to minimize temperature gradient during cooling and rewarming phases of bypass.
9.7. Termination of bypass
1. Terminate bypass as individual case and patient condition indicate.
2. Turn off gas flow before turning off blood flow.
3. Turn off water flow to heat exchanger.
4. After terminating bypass, continue to slowly recirculate through oxygenator using recirculation line and/or
reconnected arterial venous loop.
9.8. Emergency oxygenator replacement
A standby Affinity NT oxygenator with Cortiva bioactive surface should always be available during perfusion.
1. With the cardiotomy reservoir outlet line clamped, add volume if required to prime replacement oxygenator.
2. Turn off water flow to the heat exchanger; clamp and remove water lines. Remove oxygen line from gas
inlet port.
3. Clamp venous line at reservoir. Turn off blood pump and clamp arterial outlet.
4. Remove any monitoring/sample line from oxygenator.
5. Double clamp recirculation line, oxygenator inlet, and outlet tubing, and cut tubing between clamps, leaving
adequate lengths for reconnection.
6. Remove old oxygenator from holder.
7. Place replacement oxygenator in holder. Connect and band all blood lines. Connect oxygen line.
8. Connect water lines, unclamp, turn on water source, and inspect for water leaks.
9. Remove clamps from cardiotomy line, recirculation line, and the oxygenator inlet.
Warning: Do not unclamp arterial line or venous return line at this time.
10. Turn on blood pump and slowly fill the oxygenator.
11. Increase blood flow to 5 L/min through recirculation line.
12. Vent air bubbles from venous reservoir.
13. Ensure that the entire system is free of leaks and gas bubbles.
14. Remove all clamps from venous and arterial lines, clamp recirculation line, and reinitiate bypass.

10. 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, relevant tolerances for data in the
Instructions for Use, and test methods used to determine coverage, leaching, and bioactivity.
11. Important notice — limited warranty (US customers only)
A. This LIMITED WARRANTY provides the following assurance to the patient who receives an Affinity NT
oxygenator with Cortiva bioactive surface, hereafter referred to as the "Product."
(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship
prior to its Use-by date, Medtronic will, at its option: (a) issue a credit to the purchaser equal to the
Purchase price, as defined in Subsection A(2), against the purchase of the replacement Product or
(b) provide a functionally comparable replacement Product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current
functionally comparable, or replacement Product.
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 unused portion of the Product must be returned to Medtronic and shall be the property of
Medtronic.
(3) The Product must not have been altered or subjected to misuse, abuse, or accident.
(4) The Product must be used in accordance with the labeling and instructions for use provided with the
Product.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) Except as expressly provided by this LIMITED WARRANTY, Medtronic is not responsible for any direct,
incidental, or consequential damages based on any defect, failure or malfunction of the product,
whether the claim is based on warranty, contract, tort, or otherwise.
(2) THIS LIMITED WARRANTY IS MADE ONLY TO THE PATIENT IN WHOM THE PRODUCT WAS
USED. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESSED OR IMPLIED,
, decrease the total gas flow rate to decrease the amount of CO
2
removed.
2
Instructions for Use English 11