Indications For Use; Contraindications - Medtronic Affinity CP BBAP40 Gebrauchsanweisung

Affinity™ CP
Centrifugal Blood Pump with Balance™ Biosurface
1. Description
The Affinity™ CP centrifugal blood pump with Balance™ biosurface (BBAP40) is intended for use in extracorporeal circulation
1
procedures. It is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-
profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the
outlet port of the pump. To limit friction and heat generation, the Affinity CP centrifugal blood pump with Balance biosurface utilizes
a pivot-bearing design on a dual ceramic pivot.
The Affinity CP centrifugal blood pump with Balance biosurface has been sterilized using ethylene oxide.
The Affinity CP centrifugal blood pump with Balance biosurface is coated with a nonleaching biocompatible surface to reduce
platelet activation and adhesion and preserve platelet function.
The Affinity CP centrifugal blood pump with Balance biosurface couples to a remote magnetic drive unit called the external drive
motor model 560A, which interfaces with a Medtronic pump speed controller. It also couples with the emergency handcrank
model HC150A in the event of controller or power failure. Refer to the appropriate Medtronic pump speed controller operator's
manual for additional information about the external drive motor and the emergency handcrank.
The Affinity CP centrifugal blood pump with Balance biosurface also couples with the Affinity™ CP adapter to enable the pump
to be operated with the Stöckert™ and Sorin™ centrifugal pump systems or the Sarns™ and Terumo™ centrifugal systems.
The adapter may not be available in your country. Contact your Medtronic representative to confirm if the adapter is available.
For additional information on using the Affinity CP adapter or operating the Medtronic pump speed controller or accessories, refer
to the instructions for use or operator's manual.

2. Indications for Use

The Affinity CP centrifugal blood pump with Balance biosurface is used to pump blood through the extracorporeal bypass circuit
for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary
bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The Affinity CP centrifugal blood pump with Balance biosurface is driven by the External Drive Motor or the Emergency Handcrank.
The Affinity CP centrifugal blood pump with Balance biosurface is intended for use with Medtronic controllers or may be used with
the Stöckert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.

3. Contraindications

The Affinity CP centrifugal blood pump with Balance biosurface is contraindicated for use as a cardiotomy suction device. This
device, used for any other purposes than the intended use, is the responsibility of the user.
4. Warnings
4.1. Affinity™ CP Centrifugal Blood Pump
■ Read all warnings, precautions, and instructions for use carefully prior to use. Failure to read and follow instructions or failure
to observe the stated warnings could cause serious injury or death to the patient.
■
The centrifugal blood pump has not been qualified through in vitro, in vivo, or clinical studies for long-term use (longer than
6 hours) as a bridge-to-transplant or for pending recovery of the natural heart.
■
The Affinity CP centrifugal blood pump and the Affinity CP adapter are not compatible with operation in a pulsatile mode.
■
Do not use the centrifugal blood pump with an external drive motor or adapter that it is not compatible with because this may
result in reduced performance, decoupling, or damage.
1 Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
10 Instructions for Use English