Abiomed Impella 2.5, Instructions For Use Manual

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3.8 Instructions for Use & Clinical Reference Manual (US)
Table 3.3 Impella
® Catheter Components (continued)
Component Description
Repositioning unit The repositioning unit on the Impella
®
2.5, 5.0, and Impella CP
®
Catheters consists of a sheath, an anticontamination sleeve with an
anchoring ring, and suture pads.
• The sheath (with hemostatic valve) is graduated from 9 Fr to
15 Fr. It is located on the catheter shaft and allows repositioning of
the catheter.
• A guidewire access port on the Impella CP
®
may be used to
facilitate insertion of a 0.035” (or smaller) guidewire into the
arteriotomy prior to removal of the Impella
®
Catheter. A stylet
maintains the patency of the guidewire lumen.
• The anchoring ring of the anticontamination sleeve secures the
sheath to the catheter.
• The StatLock
®
compatible suture pads help secure the repositioning
sheath to the patient’s skin.
Red Impella ® plug The red Impella ® plug at the proximal end of the catheter connects the
catheter to the Automated Impella
®
Controller through a connector
cable. It contains:
• Memory that retains operating parameters in case the patient needs
to be transferred to another controller
• A pressure transducer (Impella
®
2.5 and Impella CP
®
Catheters) that
translates pressure for the pressure lumen proximal to the motor
• The placement signal lumen (Impella ® 2.5 and Impella CP ®
Catheters) that allows for pressure and waveform displays
The Impella
®
2.5 and Impella CP
®
Catheters have two sidearms: a
red pressure sidearm and a clear sidearm. The Impella ® 5.0 and LD
Catheters have only a clear sidearm.
Red pressure sidearm The red pressure sidearm on the Impella
®
2.5 and Impella CP
®
Catheters is attached to a standard pressure bag and is used to prime
the line of the pressure measurement system.
Clear sidearm The clear sidearm is attached to the purge cassette tubing. It leads to
the infusion filter, the pressure reservoir, and the check valve.
Infusion filter The infusion filter prevents bacterial contamination and air from
entering the purge lumen.
Pressure reservoir The pressure reservoir includes a flexible rubber diaphragm that
provides additional filling volume by means of an expansion chamber
during purge solution change.
Check valve The yellow check valve ensures that purge fluid does not flow in the
reverse direction when the purge solution is exchanged.
DIFFERENTIAL PRESSURE SENSOR FOR IMPELLA
®
5.0 AND LD
The Impella ® 5.0 and LD Catheters have an electronic differential pressure sensor located at
the proximal end of the 21 Fr cannula. The purpose of the pressure sensor is to generate the
placement signal, which is used by operators and the controller to monitor the position of the
Impella
® cannula relative to the aortic valve.