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1 Description
The Medtronic Affinity CP adapter Model AP40AST (Figure 1) is intended to be
used to enable the Medtronic Affinity CP centrifugal blood pumps (Model
AP40, Model BBAP40, and Model CBAP40) to be operated with the
Stöckert™ and Sorin™ centrifugal pump systems or the Sarns™ and
Terumo™ centrifugal systems.
Compatible systems:
• Stöckert and Sorin centrifugal pump systems (with drive unit
Model 60-01-04 and Model 60-01-00 and emergency drive unit
Model 60-01-35 and Model 60-01-50)
• Sarns and Terumo centrifugal systems (with drive unit Model 164267 and
manual drive unit Model 164268)
The adapter uses magnetic coupling to transfer drive motor torque to the
disposable centrifugal blood pump.
The adapter is supplied nonsterile.
The use of the adapter does not require modification of the Stöckert and Sorin
centrifugal pump systems or the Sarns and Terumo centrifugal systems.
The adapter is designed for multiple uses with different patients. The adapter
may be reused until the Use-by date on the device label.
For additional information on operating the Affinity CP centrifugal blood
pumps, refer to the instructions for use provided with the pumps.
2 Intended purpose
The Affinity CP adapter has no direct effect on the body. It enables the use of
a Medtronic Affinity CP blood pump with compatible systems (see Chapter 1).
2.1 Indications for use
Refer to the Affinity CP centrifugal blood pump IFU for indications for use.
2.2 Contraindications
Refer to the Affinity CP centrifugal blood pump IFU for contraindications.
2.3 Intended users
This device should be used only by clinicians thoroughly trained in
extracorporeal circulation procedures.
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