Abiomed Impella 2.5 Instructions For Use Manual Download

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A.1

Impella

System for Use During Cardiogenic Shock

APPENDIX A: IMPELLA

SYSTEM LIMITED SERVICE

WARRANTY (UNITED STATES)

Abiomed

, Inc. warrants that, at the time of installation, all Impella

Systems (the “Goods”) sold will

be free from defects in material and workmanship and remain free from defects under normal use
and service for a period of one (1) year from the date of shipment. Extended warranty and service may, at
Abiomed's option, be offered for an additional charge, in which event separate or additional terms and
conditions may apply. This warranty provides coverage for the Automated Impella

Controller.

This warranty does not cover routine preventative maintenance or replacement parts that are consumed
per the controller's periodic maintenance schedule outlined in the Operator’s and Service Manuals.

The express warranty set forth on this page is the only warranty given by Abiomed with
respect to any goods furnished hereunder. Abiomed makes no other warranty, express,
implied or arising by custom or trade usage, and specifically makes no warranty of
merchantability or of fitness for any particular purpose. Said express warranty shall not
be enlarged or otherwise affected by Abiomed’s rendering of technical or other advice or
service in connection with the Goods.

Abiomed shall not be liable for incidental or consequential losses, damages or expenses, directly or
indirectly arising from the sale, handling or use of the Goods, or from any other cause relating thereto,
and Abiomed’s sole responsibility under this warranty will be, at its option, to 1) repair or replace the
Goods or any components of the Goods found to be defective in workmanship or material during the
foregoing warranty period, or 2) to refund the purchase price paid. All replaced components and Goods
will become the property of Abiomed. This warranty shall not apply if the Goods have been: (a) repaired
or altered in any way by other than Abiomed or Abiomed authorized service personnel; (b) subjected
to physical or electrical abuse or misuse; or (c) operated in a manner inconsistent with Abiomed’s
instructions for use of the Goods. If Abiomed determines that a claim was not caused by Abiomed
or Abiomed’s authorized service personnel, then Buyer shall pay Abiomed for all related costs incurred by
Abiomed. This warranty is not transferable without the express written consent of Abiomed.

Under this warranty, Abiomed will provide at no charge, updates or modifications which directly affect
the safe operation of the Goods. Abiomed is not obligated to provide updates or modifications which
provide (a) product improvement or enhancement; (b) new product features, or (c) options to the Goods.

Abiomed has no obligation to provide a loaner system during service or maintenance of the Goods.
However, at Abiomed’s sole discretion, Abiomed may provide such loaner systems.

This warranty applies to the Automated Impella

Controller and not to any disposable or other

component of the Impella

System. Specific items excluded from this warranty include, but are not limited

to, pumps, external tubing, and accessories.

This warranty may not be amended without the express written consent of an authorized officer of
Abiomed.

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