12 Chapter 1
P/N 130859-US, Manual Revision: AA Haemonetics
®
Cell Saver
®
Elite
®
+ User Manual
The Haemonetics Cell Saver Elite+ Device
What is the
Purpose of This
Manual?
The Cell Saver
®
Elite
®
+ User Manual provides users with the information
needed to safely operate and maintain the Cell Saver Elite+ device and ensure
optimal performance.
The manual includes:
Detailed descriptions of the device and all components
How to safely operate the device and troubleshoot any difficulties
How to properly handle and maintain the device
Use this manual in conjunction with training supplied by qualified
Haemonetics
®
personnel.
This manual applies to device list numbers CSE-EW-US and CSE-E-US and is
not for use with software prior to revision AN.
What is the Cell
Saver Elite+
Autotransfusion
System?
The Cell Saver Elite+ Autotransfusion System provides intraoperative and
postoperative blood salvage for surgical procedures with medium to high blood
loss. The shed blood is collected in a reservoir, processed in a centrifuge bowl
to pack red blood cells (RBCs), and then washed to remove cell stroma,
platelets, activated clotting factors, extracellular potassium, free hemoglobin,
anticoagulant, and cardioplegia. The washed, packed RBCs are then pumped
to a reinfusion bag.
Prior to autotransfusion, the device can also sequester platelets using the
autotransfusion processing set in conjunction with a Sequestration set.
The Cell Saver Elite+ system consists of the following three parts:
Cell Saver Elite+ device: the electro-mechanical device and graphical
user interface (GUI) touch screen.
Disposable components: the single-use collection material including
reservoir, aspiration and anticoagulant (A&A) line, processing set,
vacuum line, and post-op lines.
Solutions: anticoagulant and saline for collecting and processing
salvaged blood.
Indications for
Use
The Haemonetics
®
Cell Saver
®
Elite
®
+ Autotransfusion System and its related
accessory components are intended for use to recover blood shed during or
subsequent to an operation or as a result of trauma, processing the blood by a
centrifugation and washing procedure, and pumping the processed red blood
cells to a product bag. The intended use of the Sequestration Protocol is to
collect an autologous, preoperative, platelet rich plasma product for reinfusion